METHODS AND APPARATUS FOR LUMINAL STENT IMPLANTATION

专利摘要:
abstract patent of invention: "methods and apparatus for implantation of luminal stent". the present invention relates to a stent delivery system, a core assembly and methods of operating them. the delivery system may comprise a catheter and the core assembly. the core assembly may comprise a constricting member, a projecting member, a core member and a stent extending along the core member. the tubular constricting member can be separated from the core member and define a capture area. the projecting member may be arranged along the core member at least partially distal to the capture area. the stent may have a first portion disposed within the capture area and a second portion, distal to the first portion, which extends through or on an external surface of the projecting member in such a way that the projecting member and the constricting member cooperate to inhibit expansion of the first portion of the stent.
公开号:BR112014020689A2
申请号:R112014020689-9
申请日:2013-02-18
公开日:2020-01-07
发明作者:Newell Gabriel；Huynh Andy；Farhat Lawrence；Holloway Kenneth
申请人:Covidien Lp；
IPC主号:

专利说明:

Descriptive Report of the Invention Patent for ’’ METHODS AND APPARATUS FOR LUMINAL STENT IMPLANTATION ”.
BACKGROUND [001] Vasculature walls, particularly arterial walls, can develop areas of pathological dilation called aneurysms. As is well known, aneurysms have thin, weak walls that are prone to rupture. Aneurysms can be the result of the weakening of the vessel wall due to illness, injury or a congenital abnormality. Aneurysms could be found in different parts of the body and the most common are aneurysms of the abdominal aorta and aneurysms in the brain or brain in the neurovasculature. When the weakened wall of an aneurisms breaks, it can result in death, especially if it is a brain aneurysm that breaks.
[002] Aneurysms are usually treated by excluding the weakened part of the vessel from the arterial circulation. To treat a cerebral aneurysm, such reinforcement is performed in many ways, including: (i) performing surgical clipping, in which a metal clip is attached around the base of the aneurysm; (ii) wrap the aneurysm with small coils of flexible wire (microspirals); (iii) using embolic materials to fill an aneurysm; (iv) using detachable balloons or spirals to occlude the parental vessel that feeds the aneurysm; and (v) implanting an intravascular stent.
[003] Intravascular stents are well known in medical techniques for the treatment of stenosis or vascular aneurysms. Stents are prostheses that expand radially or, otherwise, into a vessel or lumen to provide support against vessel collapse. Methods for delivering these intravascular stents are also well known.
[004] In conventional methods to introduce a stent with
2/115 After being inserted into a vessel and positioning it within an area of stenosis or an aneurysm, a guide catheter that has a distal tip is introduced percutaneously into a patient's vascular system. The guide catheter is advanced into the vessel until its distal tip is close to the stenosis or aneurysm. A guidewire, positioned inside an internal lumen of a second internal catheter and the internal catheter are advanced through the distal end of the guide catheter. The guide wire is then advanced out of the distal end of the guide catheter into the vessel until the distal portion of the guide wire that carries the compressed stent is positioned at the point of injury within the vessel. Once the compressed stent is located in the lesion, the stent can be released and expand to support the vessel.
SUMMARY [005] The following is a non-limiting summary of some of the modalities disclosed in this document.
[006] One embodiment disclosed in this document is a method for operating a stent delivery system within a patient's vessel. The method comprises positioning a catheter in the vessel, the catheter having a lumen that defines a geometric axis that extends between a proximal end and a distal end, such that the distal end of the catheter is in a treatment site; positioning a core assembly within the lumen of the catheter, the core assembly having (i) an elongated member comprising a distal end, (ii) an intermediate portion comprising a distal end positioned at the distal end of the member, (iii ) a stent that has a distal portion and is carried by the intermediate portion and (iv) a distal cover coupled to the distal end of the member, the core assembly being positioned inside the lumen in such a way that the end
3/115 distal of the intermediate portion is positioned axially adjacent to the distal end of the catheter with at least a portion of the distal cover, which extends radially in a space within the lumen between the distal end of the intermediate portion and the distal end of the catheter; advancing the nucleus assembly distally in relation to the catheter to allow the expansion of the distal portion of the stent, the expansion pushing the distal coverage away from the intermediate portion; and proximally removing the core assembly inside the catheter in such a way that the intermediate portion is positioned axially adjacent to the distal end of the catheter with the distal cover positioned outside the space.
[007] The additional optional aspects of this method will now be described, as follows.
[008] During the proximal removal of the nucleus assembly inside the catheter, the distal cover can be positioned outside the space to provide a gap between the intermediate portion and the catheter.
[009] The method may further comprise releasing the stent at the treatment site within the vessel. The method may further comprise further removing the nucleus assembly proximally from the lumen while holding the distal end of the catheter in place at the treatment site. The method can further comprise further inserting a second core assembly into the lumen, the second core assembly being configured to deliver a second stent to the treatment site.
[0010] The proximal withdrawal of the core assembly may comprise ever having a first free end of the distal covering from a position proximally to a position distally oriented. The distal cover can be coupled to the core assembly at a second end of the distal cover, the first end being positioned distally from the second
4/115 when the distal cover is everted.
[0011] Another embodiment disclosed in the present document is a method for operating a stent delivery system within a patient's blood vessel. The method comprises placing a catheter in the vessel, the catheter having a lumen that extends between a proximal end and a distal end, such that the distal end of the catheter is in a treatment site; advancing a core assembly distally into the catheter, the core assembly having (i) a distal portion, (ii) a distal cover extending from the distal portion and (iii) a stent having a distal portion and it is carried by the core assembly, the core assembly being advanced into the catheter in such a way that the distal cover extends proximally from the distal portion and an annular space between the distal portion and the catheter; advancing the nucleus assembly distally in relation to the catheter to allow the distal portion of the stent to expand, the expansion driving the distal coverage radially away from the nucleus assembly; and proximally removing the core assembly inside the catheter in such a way that the distal cover extends distally through the annular space.
[0012] The additional optional aspects of this method will now be described, as follows.
[0013] During the proximal withdrawal of the core assembly within the catheter, the distal cover may extend distally through the annular space to provide a clearance between the catheter and an intermediate portion of the core assembly proximal to the distal cover.
[0014] The proximal removal of the core assembly may comprise ever having a first free end of the distal cover from a position oriented proximally to a position oriented
5/115 distally. The distal cover can be coupled to the core assembly at a second end of the distal cover, the first end being positioned distally in relation to the second end when the distal cover is everted.
[0015] Another embodiment disclosed in this document is a method for operating a stent delivery system within a patient's vessel. The method comprises positioning a catheter in the vessel, the catheter having an internal wall and a lumen that extends between a proximal end and a distal end, such that the distal end of the catheter is in a treatment site; positioning a core assembly within the lumen, the core assembly comprising a distal cover extending in a proximal direction to close, at least partially, a distal portion of a stent supported on the core assembly, at least a portion of the distal coverage interposed between the distal portion of the stent and the internal wall; advancing the distal portion of the stent distally beyond the distal end of the catheter to allow expansion of the distal portion of the stent; and proximally removing the core assembly within the lumen, the distal cover being retracted within the lumen in an everted configuration and distally oriented from the core assembly.
[0016] The additional optional aspects of this method will now be described, as follows.
[0017] The distal cover may comprise an elongated flexible material having a first end and a second end, the material being coupled to the core assembly at the second end and proximally removing the core assembly may comprise ever changing the distal cover from such. so that the first end moves from a first configuration, in which the first end is located proximally to the second
6/115 of the end, for a second configuration, in which the first end is located distally from the second end.
[0018] The distal cover can comprise a plurality of elongated flexible strips having first ends and second ends, the second ends being coupled to the core assembly and removing proximally the core assembly can comprise ever changing the distal cover, in such a way that the first ends are attracted together distally to the second ends.
[0019] Removing the core assembly proximally may comprise retracting the distal cover inside the catheter in such a way that the distal cover extends distally through an annular space between the core assembly and the Internal wall.
[0020] Another modality revealed in this document is a core assembly. The core assembly comprises: a core member that has an intermediate region and a distal tip; a stent extending over the intermediate region of the nucleus member and comprising a distal portion; and a distal cover comprising a first end and a second end, the second end being coupled to the distal tip, the distal cover having a delivery orientation in which the first end (i) extends proximally to the tip distal and (li) surrounds, at least partially, the distal portion of the stent, the distal covering being movable from the delivery orientation to an everted orientation in which the first end is positioned distally from the second end.
[0021] The additional optional aspects of this core assembly will now be described, as follows.
[0022] The first end of the distal cover may comprise
7/115 gives a folded portion. The folded portion may comprise an inner layer and an outer layer, the inner layer being positioned in an intermediate way to the stent and the outer layer, the inner layer being eversible to facilitate the expansion of the stent.
[0023] The distal cover may comprise one or more elongated strips of material.
[0024] The distal cover may comprise no more than two elongated strips of material.
[0025] The distal coverage can extend over at least about one third of the stent.
[0026] The distal tip of the core member can comprise a transport structure by the core member, the distal covering being coupled to the tip structure. The tip structure can comprise at least one cross member oriented generally across the core member and the distal cover can be coupled to the tip structure by virtue of the formation of a shell that involves at least one cross member. The tip structure can comprise a spiral, and at least one cross member can comprise at least one segment of the spiral. The distal cover can form a wrapper that involves at least one segment of the spiral due to the at least partial winding around the segment.
[0027] The distal tip may comprise Teflon.
[0028] The core member may comprise a thread.
[0029] The distal cover can be configured to rotate around the core member. The second end of the distal cover can be coupled in a rotatable manner with respect to the core member. The stent can be configured to rotate around the core member, at least in part, due to the passable coupling
8/115 rotation of the distal coverage.
[0030] Another embodiment disclosed in the present document is a core assembly for a stent delivery system, the core assembly comprises a core member that extends in a longitudinal direction, the core member having a distal section and a proximal section; a tubular constricting member that has an internal lumen disposed along the core member, and that has a distal portion (i) spaced apart from the core member and (ii) that defines a capture area in the lumen; a projecting member that extends radially disposed along the nucleus member at least partially distal to the capture area, the projecting member having an external surface, and the projecting member is disposed between the distal section and the proximal section of the core; and a stent that has (i) a first portion disposed within the capture area and (ii) a second portion, distal to the first portion, which extends through or over the external surface of the projecting member in such a way that the projecting member and the constricting member cooperate to inhibit expansion of the first portion of the stent.
[0031] The additional optional aspects of this core assembly will now be described, as follows.
[0032] The assembly may additionally comprise a distal cover coupled to the distal section of the core member, the distal cover covering, at least partially, a distal portion of the stent such that, when the core assembly is arranged Slidable inside a catheter, the distal cover is arranged between the distal portion of the stent and an internal catheter wall.
[0033] The core assembly can be operative to engage the stent in both a delivery position and a re-alignment position, and the distal portion of the constricting member can be spaced
9/115 axially separated from a distal portion of the stent in both the delivery position and the repackaging position.
[0034] The constricting member may comprise a sheath that has a distal end and an internal lumen. The projecting member may have an external cross-sectional profile that is equal to or larger than a cross-sectional profile of the lumen of the constricting member.
[0035] The distal section of the nucleus member may be a cuneiform distal section.
[0036] The core member may comprise a thread.
[0037] The projecting member and the constricting member can attach the stent by inducing a variable diameter in the stent between the first portion and the second portion.
[0038] The projecting member can comprise a generally cylindrical outer surface, and the capture area can be defined between an external surface of the core member and an internal surface of the tubular constricting member, and the external surface of the projecting member can be displaced radially. from the outer surface of the core member. The external surface of the projecting member can be displaced radially from the internal surface of the constricting member. The outer surface of the projecting member can be spaced radially between the outer surface of the core member and the inner surface of the constricting member.
[0039] The second portion of the stent can be supported on the external surface of the projecting member.
[0040] The stent can be engaged between the projecting member and the constricting member through a pressure fitting to inhibit the expansion of the first end of the stent.
[0041] The stent can be engaged between the projecting member and the constricting member in an interference fit to inhibit ex
10/115 expansion of the first end of the stent.
[0042] The projecting member can be mounted in a rotatable way on the core member.
[0043] The projecting member may comprise an annular ring supported on the core member.
[0044] The capture area can be defined between the distal portion of the constricting member and the nucleus member.
[0045] The projecting member can be spaced axially apart from the distal portion of the constricting member.
[0046] Another modality disclosed in this document is the method for operating a stent delivery system. The method comprises moving a core assembly through a catheter to a treatment site, the core assembly comprising (i) a stent having a proximal section and a distal section, (ii) a core member having a distal section and a proximal section, (iii) a projecting member arranged along the nucleus member between the distal section and the proximal section, and (iv) a constricting member axially spaced apart from the projecting member and the distal portion of the stent, being that the constricting member extends over a proximal section of the first portion of the stent with the projecting member seated under a second portion of the proximal section of the stent, distal to the first portion, such that the stent is attached between a distal end of the constricting member and a proximal end of the projecting member in a delivery position; proximally retract the catheter in relation to the core assembly until the distal constricting end of the limb and the first portion of the stent are positioned distally beyond a distal end of the catheter while maintaining the first portion of the stent in a flexed state when attaching the stent between the distal constricting end of the limb and the proximal end of the projecting limb in the delivery position
11/115 with the distal section of the nucleus member extending distally from the stent; and expanding a distal portion of the stent in apposition with a vessel wall while maintaining the first portion of the stent in the flexed state in the delivery position.
[0047] The additional optional aspects of this method will now be described, as follows.
[0048] The method may additionally comprise proximally removing the core assembly from inside the catheter to rewire the stent into the catheter after the distal portion of the stent has been expanded.
[0049] Expanding the distal portion of the stent may comprise unrolling a distal covering that covers, at least partially, the distal portion of the stent. The method may further comprise ever maintaining the distal cover in such a way that a first free end of the distal cover moves from a position proximally to a position distally oriented.
[0050] Expanding the distal portion of the stent may comprise automatically expanding the distal portion of the stent as the distal portion of the stent exits the catheter.
[0051] The method may additionally comprise releasing the first portion of the stent to enable the first portion of the stent to expand in apposition with the vessel wall. Releasing the first portion of the stent may comprise proximally retracting the constricting member in relation to the projecting member to enable the first portion of the stent to expand in apposition with the vessel wall. The method may further comprise proximally retracting the catheter core assembly to remove the catheter core assembly. The method may further comprise inserting a second core assembly into the catheter to deliver a second stent to the treatment site.
12/115 [0052] Another modality disclosed in this document is a stent delivery system. The system comprises a catheter that has a distal end; and a core assembly comprising a tubular constricting member comprising a lumen and a distal portion, a stent having a proximal portion disposed within the lumen and a distal portion disposed outside the lumen, a core member extending within the lumen and distally beyond the distal portion of the stent, and a protruding member radially coupled to the nucleus member and which is arranged distally from the distal portion to the constricting member within the distal portion of the stent; in which the constricting member and the projecting member collectively form a grasping mechanism that engages the proximal portion of the stent in a flexed state, the grasping mechanism being operative to (i) exert a distal pushing force on the stent to advance distally the stent in relation to the catheter until the proximal portion of the stent is distally beyond the distal end of the catheter and (ii) exert a proximal traction force on the stent to proximally remove the stent from inside the catheter when the proximal portion of the stent is distally beyond distal end of the catheter and the stent is expanded, at least partially, in apposition with a vessel wall.
[0053] The additional optional aspects of this system will now be described, as follows.
[0054] The gripping mechanism can be configured to exert the distal impulse force and the proximal traction force alone, without the cooperation of other components or structures.
[0055] The gripping mechanism can be formed collectively by the distal portion of the constricting member and a proximal portion of the projecting member.
[0056] An arcuate tip of the core member may extend distally to the projecting member.
13/115 [0057] When the assembly is oriented substantially in a straight line, the projecting member may optionally not press the stent against an internal surface of the catheter.
[0058] The projecting member may comprise a generally cylindrical outer surface that is spaced radially apart from an internal surface of the catheter in such a way that when the assembly is oriented substantially in a straight line, the projecting member does not press the stent against the internal surface of the catheter.
[0059] The projecting member may comprise a generally cylindrical outer surface that is spaced radially apart from an inner surface of the catheter in such a way that when the assembly is oriented substantially in a straight line, a radial distance between the outer surface of the projecting member and the lumen of the internal catheter is larger than a stent thickness.
[0060] Another modality disclosed in this document is a stent delivery system. The system comprises a microcatheter that has a distal end configured to be inserted into a blood vessel; a constricting member that extends into the microcatheter and has a distal portion; a nucleus member extending into the microcatheter, the nucleus member having a distal segment; at least one glove positioned around the distal segment of the core member and coupled in a rotatable manner to the core member; and a stent that extends along the distal segment of the nucleus member, a proximal end of the stent that engages with the distal portion of the constricting member and the glove to restrict the movement of the stent in relation to the constricting member and the glove while the core member is capable of rotating in relation to the stent, the constricting member and the glove.
[0061] The additional optional aspects of this system will now be described, as follows.
14/115 [0062] The core member may be capable of pivoting in relation to the stent and the microcatheter when a distal end of the stent is expanded in contact with the vessel.
[0063] The microcatheter may comprise a lumen that has a central geometric axis, and the distal segment of the nucleus member may comprise an arcuate tip that extends transversely to the geometric axis.
[0064] The glove can be positioned adjacent to the distal portion of the constricting member along the core member in an engaged position. The constricting member can have a capture area configured to receive a first portion of the stent, the stent having a second portion, distal to the first portion, supported on an external surface of the glove to restrict the movement of the stent in relation to the glove and to the constricting member. The constricting member and the glove can cooperate to grasp the proximal end of the stent.
[0065] The core member can extend into the constricting member.
[0066] The system may additionally comprise a distal cover that extends proximally from the distal segment of the nucleus member and interposed between an external surface of the stent and an internal surface of the microcatheter. The distal tip can be swivelably coupled to the core member. The glove and the distal cover can allow the rotation of the core member in relation to the stent.
[0067] The system may additionally comprise an actuator attached to a proximal portion of the core member, the actuator being configured to grant rotation to the core member. [0068] The core member may comprise a delivery thread. [0069] Another modality disclosed in this document is a method for operating a rotatable stent delivery system.
11/15
The method comprises advancing a distal end of a catheter into a blood vessel; advancing the delivery system inside the catheter, the delivery system comprising a stent, a constricting member, a core wire that has a central longitudinal geometric axis, and a glove coupled liable to rotate around the core wire, being that the stent extends over the glove and is restricted of movement in relation to the glove and the constricting member, the core wire being able to rotate in relation to the stent, the glove and the constricting member; and advancing the core wire distally to guide the delivery system along a path of the vessel.
[0070] The additional optional aspects of this method will now be described, as follows.
[0071] Advancing the stent may comprise moving the stent into position with a blood vessel wall.
[0072] The core wire may comprise a more distal curvilinear tip that curves away from the geometric axis, and the method may further comprise rotating the tip by means of the core wire in relation to the stent, the sleeve and the constricting member. The tip can be advanced towards a vessel fork. Rotating the tip may comprise directing the tip in a direction away from the apex of the bifurcation.
[0073] Another modality disclosed in this document is a stent delivery system. The system comprises a microcatheter that has a lumen; a constrictor sheath that has a distal portion and extends into the lumen of the microcatheter; a core member extending into the lumen of the microcatheter; at least one glove positioned around and swivelably coupled to the core member; and a self-expanding stent that has (i) a first portion disposed within the lumen of the sheath, and (ii) a second portion distal from the first portion that extends over an external surface
16/115 of the glove, while the core member is liable to rotate in relation to the stent, the constricting member and the glove.
[0074] The additional optional aspects of this system will now be described, as follows.
[0075] The glove can have an external profile with a cross-section that is larger than an internal profile with a cross-section of the lumen of the constrictor sheath.
[0076] The core member may extend into a lumen of the constrictor sheath.
[0077] When in a delivery position, the first portion of the stent may be restricted in expansion and restricted in longitudinal movement in relation to the glove and the distal portion of the sheath. The stent may have a first diameter in the first portion and a second diameter in the second portion, larger in size than the first diameter, such that the stent is trapped between the sleeve and the distal portion of the sheath.
[0078] A collective external profile of the stent and the glove may be larger than the internal profile of the sheath.
[0079] The distal portion of the constrictor sheath (i) may be spaced apart from the core member and (ii) may have a capture area. An outer surface of the glove can be moved radially from the capture area.
[0080] At least one aspect of the disclosure provides methods and apparatus for delivering an occlusion device or devices (eg, stent or stent) to the body. The occlusion device can easily adapt to the shape of the tortuous vasculature vessels. The occlusion device can be used in a variety of applications. For example, in some embodiments, the occlusion device may direct blood flow within a vessel away from an aneurysm. Furthermore, such an occlusion device may allow
17/115 that adequate blood flow is provided to adjacent structures in such a way that the structures, regardless of whether they are branched vessels or tissues that require oxygen, are not deprived of the necessary blood flow.
[0081] The delivery of an intravascular stent to a treatment site within a patient's vessel requires substantial precision. Generally, during the implantation process, a stent is passed through a vessel to a treatment site. The stent can be expanded at the treatment site, often due to the possibility of a first end of the stent expanding and consequently slowly expanding the rest of the stent until the entire stent has been expanded. The process of initially attaching the vessel wall while the first end of the stent expands can be termed as depositing the stent. The final position of the stent within the vessel is usually determined by its initial placement or deposit within the vessel. In some situations, the stent may initially be deposited in a less than ideal location within the vessel. With the use of traditional methods and devices, it can be very difficult for a clinician to reposition the stent inside the vessel. For example, a clinician may not be able to recapture, flex, withdraw, or retrain the stent back into the catheter after the stent has been partially expanded into the vessel. Therefore, the initial deposit is critical for successful stent placement.
[0082] In accordance with an aspect of at least some modalities disclosed in this document, it is the realization that a medical device delivery system can be configured to advantageously enable a clinician to recapture, flex, withdraw, or redeploy a stent within a delivery system catheter after the stent has been expanded, at least partially, and deposited in the vessel to enable the clinician to improve the placement of the
18/115 stent inside the vessel. In addition, some modalities can be configured to allow a clinician to recapture, bend, remove or retrain the stent even if the entire stent has moved out of the catheter lumen and has expanded, at least partially, against the vessel wall. In addition, some modalities can be provided in such a way that the delivery system can engage and retain any braided stent without requiring special purpose engagement structures on the stent.
[0083] In order to allow a clinician to recapture, fold, remove or re-stent a stent within a delivery system, some modalities enable a core assembly that is slidably disposed within a catheter and capable of holding, grasping or engage at least a portion of the stent to control the movement, arrangement and expansion of the stent. In some embodiments, the core assembly may comprise a constricting member and a core member. The stent can extend over the core member and into a recess formed by the constricting member to engage or secure a portion of the stent.
[0084] Optionally, the core assembly can also comprise a projecting portion or member arranged along the core member. In such modalities, the stent can extend over the projecting member and into the recess.
[0085] For example, the projecting member and the constricting member can collectively form a grasping mechanism that engages or holds the stent. The gripping mechanism can engage a first or proximal portion of the stent in a flexed state. The gripping mechanism can provide a grip or interference fit between the constricting member and the projecting member to inhibit expansion of the first end of the stent. The grasping mechanism can enable the stent to be removed, recaptured, retracted, or
19/115 retrained inside the catheter until after the stent has been moved out of the catheter lumen (i.e., the catheter has been completely removed from the stent) and the stent has expanded, at least partially, in apposition with the vessel wall .
[0086] The grasping mechanism can enable the core assembly to exert a pulling force and a pulling force on the stent to adjust its axial position in relation to the catheter. In some embodiments, the grasping mechanism may be operative to exert a distal force on the stent to advance the stent distally from the catheter until the proximal portion of the stent is distally beyond the distal end of the catheter. In addition, the grasping mechanism can also be operative to exert a proximal traction force on the stent to proximally remove the stent from inside the catheter when the proximal portion of the stent is distally beyond the distal end of the catheter and the stent is expanded, at least partially, in apposition with a vessel wall. The gripping mechanism can be configured to exert distal force and proximal traction force on its own without the cooperation of other components or structures.
[0087] In some embodiments, the stent may be attached or engaged between the projecting member and a distal end of the constricting member (which may be a sheath) in order to prevent the expansion of a first or proximal portion of the stent. For example, the projecting member and the constricting member can attach the stent by inducing a variable diameter in the stent between the first portion and the second portion.
[0088] In some modalities, the assembly can be configured in such a way that the core member has a distal section and a proximal section. The distal section of the nucleus member can be a cuneiform distal section. The core member can understand
20/115 a thread. For example, the distal section of the nucleus member may comprise a distal tip. The distal tip core member may comprise polytetrafluoroethylene (PTFE or TEFLON®).
[0089] The constricting member may have an internal lumen that is configured to receive the core member. In addition, the constricting member may have a distal portion that can be spaced apart from the core member and may have a capture area in the lumen. The capture area can be defined between the distal portion of the constricting member and the nucleus member. For example, the capture area can be defined radially between an outer surface of the core member and an inner surface of the tubular constricting member.
[0090] Additionally, the projecting member can be arranged along the core member at least partially distal to the capture area. The projecting member can extend radially. In addition, the projecting member may have an external surface. In some embodiments, the projecting member can be arranged axially between the distal section and the proximal section of the nucleus member. In addition, the stent can have a first portion and a second portion. The first portion may be a proximal portion that is disposed within the capture area. The second portion can be arranged distally from the first portion. The second portion may extend through or on an external surface of the projecting member so that the projecting member and the constricting member cooperate to inhibit the expansion of the first stent portion.
[0091] In some embodiments, the nucleus member may extend into the lumen of the stent and distally beyond the distal portion of the stent. The projecting member can be coupled to the core member and be disposed distal to the distal portion of the constricting member within the distal portion of the stent.
[0092] The projecting member can optionally have a surface
21/115 of external generally cylindrical. For example, the projecting member may comprise an annular ring coupled or supported on the core member. The outer surface of the projecting member can be displaced radially from the outer surface of the core member. Additionally, the projecting member can be spaced axially apart from the distal portion of the constricting member. For example, the external surface of the projecting member can be displaced radially from the internal surface of the constricting member. In addition, the external surface of the projecting member can be displaced radially from the capture area, which is defined by the constricting member and the core member. In some embodiments, the outer surface of the projecting member may be spaced radially between the outer surface of the core member and the inner surface of the constricting member. In addition, the second portion of the stent may extend over or be supported on the external surface of the projecting member.
[0093] The projecting member can be arranged, at least partially, distal to the distal portion of the constricting member. Additionally, when the assembly is oriented substantially in a straight line, the projecting member can be configured in such a way that it does not press the stent against the internal surface of the catheter.
[0094] The projecting member can also have an external surface that is spaced radially apart from the internal surface of the catheter in such a way that when the assembly is oriented substantially in a straight line, the projecting member does not press the stent against the internal surface of the catheter. For example, the projecting member may have a generally cylindrical outer surface. In addition, when the assembly is oriented substantially in a straight line, a radial distance between the external surface of the projecting member and the internal surface of the catheter may be larger than a stent thickness.
22/115 [0095] In addition, in some embodiments the catheter can be supplied in order to form a stent delivery system. The stent delivery system can comprise the catheter and a core assembly. The catheter may have a distal end. As noted above, the core assembly may comprise a tubular constricting member, a stent, a core member and a radially protruding member.
[0096] In accordance with some modalities, the constrictor sheath may include a lumen that has an internal profile with a cross section. The projecting member may have an external profile with a cross-section that is equal to or larger than the internal profile of the catheter. The cross-sectional external profile of the projecting member may be larger than the internal profile of the catheter. The stent can extend over the projecting member and into the constricting sheath in such a way that the stent has a first diameter in the proximal portion of the stent and a second diameter in the distal portion of the stent, with a larger size than the first diameter. Thus, the stent can be attached between the projecting member and the distal end of the sheath. In accordance with some modalities, the projecting member can be mounted in a rotatable way on the core member, as further discussed in this document. In addition, the projecting member and the core member can also be formed from a continuous piece of material.
[0097] Additionally, a collective external profile of the stent and the proximal member may be larger than the internal profile of the sheath. The core member can be configured to be steerable when the stent is partially expanded within a blood vessel by being able to rotate in relation to the stent and the constrictor sheath. In some modalities that comprise a projecting member, the core member may also be capable of turning in
11/23 in relation to the projecting member.
[0098] The delivery of a stent in a vessel and the subsequent expansion of the stent in apposition with the vessel wall can present some challenges in tortuous vessels. For example, during delivery to the treatment site, the delivery system can be configured to comprise one or more rotatable components that enable components of the system to rotate relative to each other while the delivery system traverses tortuous geometries. Such flexibility can reduce the total push force required and tends to prevent rebounding ”of the stent when it is drawn and / or expanded into the vessel.
[0099] For example, in accordance with some modalities, the delivery system may comprise a rotatable core assembly. In such modalities, the core member can rotate independently of the projecting member (if present) and / or the stent and the constricting member inside the catheter to reduce the rebound, and also, to allow the targeting of the core member, as discussed further in the this document. Such a pivoting ability can facilitate the movement of the core assembly through a delivery system catheter to reduce the delivery force required to reach the treatment site.
[00100] Additionally, the rotatable core assembly can be configured to allow the core member to rotate independently of the stent disposed in the vessel. Thus, the projecting end of the core member can be rotated without interrupting contact between the vessel wall and the stent. Thus, the clinician can rotate a projecting end, distal, from the core member to preferably align the projecting end with the geometry of the adjacent vessel to prevent abrasion or perforation of the vessel wall while advancing the assembly.
24/115 [00101] For example, after the stent has been moved to the treatment site, the core member of the delivery system can often include a distally projecting end that can be displaced distally as the stent is expanded and released. The distal movement of the projecting end represents a danger of potentially rubbing or puncturing a wall of the vessel into which the stent is being delivered. In addition, when the stent is delivered adjacent to a vessel bifurcation or a sharp curve in the vessel, the vessel's geometry, such as a peak in the bifurcation, can be particularly difficult to avoid.
[00102] In some embodiments, a core assembly may be rotatable by providing a projecting member that is mounted rotatable in the core member. In such embodiments, the core member can be coupled in a rotatable manner with respect to its projecting member in order to enable the core member to rotate in relation to the projecting member, the constricting member and the stent. For example, the projecting member may comprise an annular component that is rotatable in the constrictor mechanism.
[00103] Thus, a delivery system with a directable or rotatable stent can be provided. The modalities of such a system can comprise a microcatheter, a core member and a stent. The microcatheter may have a distal end configured to be inserted into a blood vessel. The core member can extend into the microcatheter. In addition, the core member may have a distal portion and an intermediate portion proximal to the distal portion. The stent can extend along the intermediate portion. In addition, the core member can be configured to be steerable when the stent is partially expanded within the vessel as it is capable of pivoting in relation to the stent and the microcatheter. In
According to the agreement, the core member can be steerable to avoid dislodging the stent from the vessel wall and abrasion or perforation of the vessel wall.
[00104] In some modalities, the system may also include a projecting member. The projecting member can be positioned along the core member in the intermediate portion and can be swiveled to the core member. In some embodiments, the core member may comprise an arcuate tip that extends distally to the projecting member. The distal portion of the core member may comprise the arcuate tip, which may extend transversely to a longitudinal geometric axis of the microcatheter. The arcuate tip can extend transversely or curve away from a central geometric axis of the lumen of the microcatheter. The microcatheter can be either like the constrictor sheath or the catheter discussed in this document.
[00105] In some embodiments, the distal portion may comprise an assembly that includes the distal cover and a structure of the distal tip. The tip structure can be coupled in a rotatable manner or fixedly in relation to the core member. In addition, the distal cover can be attached to the tip structure.
[00106] The structure of the distal tip may comprise at least one member or component that can be driven by the core member. In some embodiments, at least one member can be oriented generally across or parallel to the core member. For example, the tip structure may comprise one or more spirals, one or more bands of material that extend circumferentially, one or more clips, and / or other structures that can pass smoothly into a vessel in the distal portion of the member of core. In addition, at least one member can comprise at least one segment of the spiral or other structure.
26/115 [00107] In some embodiments of a rotatable core assembly, the distal portion of the core member may comprise a distal tip structure and / or distal cover that can be rotatably coupled to the core member . Thus, a rotatable interconnection between the distal tip structure and / or distal cover and the core member can enable the core member to rotate freely from the distal tip structure and / or distal cover, thus preventing transmission of any efforts to rotate or twist the stent through the distal cover. For example, the distal cover can be configured to rotate around the core member. In addition, the second end of the distal cover can be coupled in a rotatable manner with respect to the core member. Furthermore, the stent can be configured to rotate around the core member, at least in part, due to the rotatable coupling of the distal cover.
[00108] In operation, after the catheter has been positioned in the blood vessel, the stent can be partially expanded in apposition with a vessel wall. The clinician can rotate a curvilinear tip more distal from the core member of the delivery system. The tip can be configured to curve away from a central longitudinal geometric axis of the core member. Thus, when rotated, the curvilinear tip of the core member can rotate in relation to the stent and the constricting member. Additionally, as noted above, in some embodiments that comprise a projecting member, the core member can be swivelably coupled to the projecting member. In such modalities, when rotated, the curvilinear tip of the core member can rotate in relation to the stent, the projecting member and the constricting member. Accordingly, the clinician can align the curved tip with a path of the vessel to avoid rubbing or puncturing the vessel wall. Consequently, the core member
27/115 can be advanced distally to guide the core member along a path of the vessel. Such methods and systems can be particularly useful when the geometry of the vessel includes a bifurcation or a sharp curve in the vessel, especially for guiding the tip of the core member away from an apex of a bifurcation adjacent to the treatment site.
[00109] In accordance with yet other modalities disclosed in this document, the core assembly can be configured to comprise a distal portion that allows a distal or front end of the core assembly and the stent to be passed with the use of a lubricant through of a catheter while also facilitating the re-routing of the distal portion inside the catheter, as desired.
[00110] In some embodiments in which the distal portion comprises a distal cover, the distal cover can be attached to the core member and, at least partially, surround or cover the distal portion of the stent. Thus, when the core assembly is slidably disposed within the catheter, the distal cover can be positioned, for example, radially between, the distal portion of the stent and the internal catheter wall.
[00111] In embodiments comprising a distal cover, the distal cover may comprise a flexible material that can extend previously over at least a portion of the stent in order to provide a lubricating interface between the core assembly and an internal surface of the lumen of the catheter.
[00112] The distal cover can be fixed or attached to the structure of the distal tip or core wire with the use of a variety of fixation means. According to some modalities, the distal cover can be attached to the structure of the distal tip due to the formation of an envelope that involves at least one member of the structure of the distal
28/115 distal tip. For example, the distal cover can form a wrapper that surrounds the tip structure, for example, at least one segment of the spiral, by virtue of the at least partial winding around the segment.
[00113] The distal cover may comprise one or more elongated strips of material. For example, the distal cover may comprise a pair of elongated strips that extend longitudinally that cover, at least partially, or surround the distal portion of the stent. In some embodiments, the distal cover comprises no more than two elongated strips of material. In some embodiments, the distal cover may be cut from a tubular member in such a way that a plurality of elongated strips are formed and interconnected by an annular ring of material.
[00114] Additionally, the distal cover can be configured to allow the distal end of the stent to expand when the distal end of the stent is moved axially beyond a distal end of the catheter. In some embodiments, the distal coverage may be configured to provide little or no constricting force or otherwise inhibit expansion of the distal end of the stent.
[00115] The distal coverage can be configured to invert, everter, or otherwise, move from one position to another. In accordance with some embodiments, the distal cover may comprise a first end and a second end. The first end can be a free first end, and the second end can be coupled to the distal portion. The distal cover may have a first delivery position, or proximally oriented, orientation, or configuration in which the first end extends proximally to the distal portion of the core and copper member, at least partially, or surrounds the distal portion of the stent . The co
29/115 Distal coverage can be movable from the first delivery position or proximally oriented, orientation, or configuration, in which the first free end is located proximally to the second end, to a second, everted, rewiring position or position distally oriented, orientation, or configuration in which the first end is positioned distally from the second end. Thus, the distal cover may allow the core assembly to be easily removed or received within the catheter lumen. In addition, the distal portion of the constricting member can be spaced axially apart from a distal portion of the stent in both the delivery position or configuration and the repackaging position or configuration.
[00116] In some modalities, the distal coverage may extend previously in relation to the fixation point of the distal coverage and / or the structure of the distal tip while the stent is being delivered to the treatment site. For example, the distal coverage may extend over at least about one third of the stent. In addition, the distal cover may be everted to extend distally from the point of attachment of the distal cover and / or the structure of the distal tip after the distal end of the stent has been expanded.
[00117] Various methods for operating the core assembly and the stent delivery system are also provided. Initially, in order to position the stent delivery system within a patient's vessel, a clinician may first place a catheter in the vessel. The catheter may have a lumen that defines a geometric axis that extends between a proximal end and a distal end in such a way that the distal end of the catheter is at a treatment site. The clinician can position a core assembly within the lumen of the catheter. The clinician can also advance the assembly of
30/115 nucleus distally inside the catheter. Consequently, varied implementations of methods can be performed using one or more of the core assemblies disclosed in this document.
[00118] For example, the operation of a modality of a stent delivery system can be carried out by first moving a core assembly through a catheter to a treatment site. A constricting member of the assembly can be configured to receive a portion of a proximal portion of the stent, such that the stent is trapped between a distal end of the constricting member and a proximal end of a projecting member in a delivery position. The catheter can be proximally retracted in relation to the core assembly until the distal constricting end of the limb and the proximal portion of the stent are positioned distally beyond a distal end of the catheter while holding the proximal portion of the stent in the delivery position or configuration with the distal section of the nucleus member that extends distally from the stent. In addition, a distal portion of the stent can be expanded in apposition with a vessel wall while maintaining the proximal portion of the stent in the delivery position.
[00119] Thus, in accordance with some modalities, the core assembly can be proximally removed inside the catheter in order to reshape the stent inside the catheter after the distal portion of the stent has already been expanded. When using a self-expanding stent, a distal portion of the stent may expand automatically when the distal portion of the stent exits the catheter. In addition, in order to expand a distal portion of the stent, a distal cover, which surrounds or covers, at least partially, a distal portion of the stent, can be unrolled.
[00120] Furthermore, in some modalities in which the
31/115 core gem comprises distal cover, the distal cover can extend in a proximal direction to close, at least partially, a distal portion of a stent supported on the core assembly. At least a portion of the distal cover can be interposed between the distal portion of the stent and the inner wall. The distal portion of the stent can be distally advanced beyond the distal end of the catheter to allow expansion of the distal portion of the stent. The core assembly can then be removed from within the lumen, such that the distal cover is retracted into the lumen in an everted and distally oriented configuration from the core assembly.
[00121] Additionally, in some embodiments, in which the core assembly has (i) an elongated member comprising a distal end, (li) an intermediate portion comprising a distal end positioned at the distal end of the member, (iii) a stent that has a distal portion and is conducted by the intermediate portion, and (iv) a distal covering coupled to the distal end of the member, the core assembly being positioned within the lumen such that the distal end of the intermediate portion is positioned axially adjacent to the distal end of the catheter with at least a portion of the distal cover extending into a space within the lumen radially between the distal end of the intermediate portion and the distal end of the catheter. The clinician can then advance the nucleus assembly distally from the catheter to allow expansion of the distal portion of the stent. The expansion can propel the distal cover away from the middle portion. Finally, the clinician can proximally remove the core assembly from inside the catheter in such a way that the intermediate portion is positioned axially adjacent to the distal end of the catheter with the distal cover positioned outside the space. There
32/115 In some modalities, during the proximal removal of the core assembly from inside the catheter, the distal cover can be positioned outside the space to provide a gap between the intermediate portion and the catheter.
[00122] Furthermore, in some embodiments, the core assembly may have (i) a distal portion, (ii) a distal covering that extends from the distal portion and (iii) a stent that has a distal portion and is conducted by the core assembly. The core assembly can be advanced into the catheter such that the distal cover extends proximally from the distal portion and an annular space between the distal portion and the catheter. The clinician can advance the nucleus assembly distally from the catheter to allow expansion of the distal portion of the stent. The expansion can propel the distal cover radially away from the core assembly. In addition, the core assembly can be proximally removed from inside the catheter in such a way that the distal cover extends distally through the annular space. In such embodiments, during the proximal removal of the core assembly from within the catheter, the distal cover may extend distally through the annular space to provide a spacing between the catheter and an intermediate portion of the core assembly proximal to the distal cover.
[00123] Additionally, the methods of the methods may further comprise advancing the nucleus assembly distally into the catheter in such a way that a proximal end of the stent is positioned outside the lumen. The method can be carried out to further understand the step of releasing the stent at the treatment site within the vessel. The method may also comprise proximally removing the lumen core assembly while holding the distal end of the catheter in place at the treatment site. In addition, a second core assembly can be inserted into the
33/115 lumen. The second core assembly can be configured to deliver a second stent to the treatment site.
[00124] In some method embodiments, removing the core assembly proximally may comprise ever having a first free end of the distal cover from a position proximally oriented to a position distally oriented. In addition, the distal cover can be coupled to the core assembly at a second end of the distal cover, and the first end can be positioned distally from the second end when the distal cover is everted.
[00125] In accordance with yet other modalities of the methods, the distal cover may comprise a plurality of elongated flexible strips having first ends and second ends. The second ends can be attached to the core assembly. In such embodiments, removing the core assembly proximally may comprise ever maintaining the distal cover in such a way that the first ends are attracted together distally to the second ends.
[00126] In accordance with some implantations, a targetable stent delivery system that can comprise a microcatheter, a core member, a projecting member and a stent is provided. The microcatheter may have a distal end configured to be inserted into a blood vessel. The core member can extend into the microcatheter. The core member may have a distal portion and an intermediate portion proximal to the distal portion. The projecting member can be positioned along the core member in the intermediate portion. The projecting member can be swiveled to the core member. The stent can extend over the projecting member and along the intermediate portion. Additionally, the core member can be configured to be
34/115 steerable when the stent is partially expanded inside the vessel as it can be rotated in relation to the stent and the microcatheter. [00127] The core member can be steerable to prevent (i) dislodgement of the vessel wall stent and (ii) perforation of the vessel wall. In addition, the microcatheter may comprise a lumen that has a central geometric axis, and the distal portion of the core member may comprise an arcuate tip that extends transversely to the geometric axis. In addition, the system may additionally comprise a constricting member disposed along the core member and a spaced distal portion (I) separated from the core member and (il) that has a capture area. The projecting member can be positioned adjacent to a distal end of the constricting member. The stent may have (i) a first portion disposed within the capture area and (ii) a second portion, distal to the first portion, supported on an external surface of the projecting member to secure the stent between the projecting member and the constricting member. [00128] The system may also comprise a distal cover that extends proximally from the distal portion of the nucleus member and Interposed between an external surface of the stent and an internal surface of the microcatheter. The system may also comprise a distal tip attached to the core member in the distal portion thereof, and the distal cover may be attached to the distal tip. The distal tip can be swivelably coupled to the core member. The distal tip and the core member can be formed of a continuous piece of material.
[00129] The system can additionally comprise an actuator attached to a proximal portion of the core member and the actuator can be configured to give rotation to the core member.
[00130] Methods for operating a targetable stent delivery system can be provided. According to aspects of some
35/115 embodiments disclosed in this document, the delivery system may comprise a tubular constricting member, a member or core wire that has a central longitudinal geometric axis, an annular projecting member coupled in a rotatable manner to the core wire, and a more distal curvilinear tip that curves away from the geometric axis. The stent can extend over the projecting member and be trapped between the projecting member and the constricting member in such a way that the core wire can be rotated in relation to the stent, the projecting member and the constricting member. In accordance with some aspects of methods disclosed in this document, a clinician may position a distal end of a delivery system catheter in a blood vessel. The clinician can partially expand a delivery system stent in apposition with a blood vessel wall. The clinician can then rotate the tip in relation to the stent, the projecting member and the constricting member. For example, the clinician can rotate the tip until it reaches a desired orientation in relation to the geometry of the blood vessel. Consequently, the clinician can advance the core wire distally to guide the core wire along a path of the vessel.
[00131] In some modalities, when the clinician rotates the tip, the relative movement between the core wire and the stent can prevent displacement of the stent from the vessel wall. Additionally, in some modalities, the clinician may advance the tip towards a vessel bifurcation. In addition, in some modalities, the method can be implemented in which rotating the tip comprises directing the tip in a direction away from the apex of the bifurcation.
[00132] In accordance with some deployments, a stent delivery system comprising a constrictor sheath, a core member, a projecting member and a stent can be provided. The constrictor sheath may have a distal end and a lumen
36/115 which has an internal profile with cross section.
[00133] The stent may have (i) a proximal portion disposed within the lumen of the sheath and (ii) a distal portion that extends over an external surface of the projecting member. In some embodiments, the distal portion may be covered, at least partially, in the region of the distal nucleus member. The stent may have a first diameter in the proximal portion and a second diameter in the distal portion with a size larger than the first diameter, such that the stent is trapped between the projecting member and the distal end of the sheath.
[00134] In some embodiments, the nucleus member may have a distal region and extend into the sheath lumen. The projecting member can be rotatable mounted on the core member. For example, the projecting member can be mounted in a rotatable manner on the core member proximal to the distal region. The projecting member may have an external profile with a cross-section that is equal to or larger than the internal profile of the catheter. In some embodiments, the projecting member may have an external profile with a cross-section that is larger than the internal profile of the catheter.
[00135] The stent can be attached between the projecting member and the distal end of the sheath to prevent expansion of the first portion of the stent. Additionally, a collective external profile of the stent and the proximal limb may be larger than the internal profile of the sheath. The core member can be configured to be steerable when the stent is partially expanded within a blood vessel because it can be rotated in relation to the stent, the projecting member and the constrictor sheath. The external profile projecting member can be generally cylindrical. The projecting member may comprise a tubular structure fitted over the core member. The constrictor sheath may comprise a distal (i) spaced portion
37/115 separate from the core member and (ii) have a capture area. Optionally, an external surface of the projecting member can be moved radially from the capture area. The stent can be engaged between the projecting member and the constricting sheath using a pressure fitting to prevent expansion of the first portion of the stent. The stent can be engaged between the projecting member and the constricting sheath in an interference fit to prevent expansion of the first portion of the stent.
[00136] Additional features and advantages of the technology in question will be exposed in the description below and, in part, will be apparent from the description, or can be learned by practicing the technology in question. The advantages of the technology in question will be perceived and obtained by the structure pointed out particularly in the written description and modalities of the same, as well as the attached drawings. [00137] It should be understood that both the aforementioned general description and the following detailed description are exemplary and explanatory and are intended to provide additional explanation of the technology in question.
BRIEF DESCRIPTION OF THE DRAWINGS [00138] The accompanying drawings, which are included to provide additional understanding of the technology in question and are incorporated and constitute a part of that specification, illustrate aspects of the disclosure and together with the description serve to explain the principles of the technology in question.
[00139] Figure 1 is a schematic cross-sectional view of a stent delivery system, according to one or more revealed modalities.
[00140] Figure 2 is a schematic side view of a core assembly of the system shown in Figure 1 with a stent mounted on it, according to some modalities.
38/115 [00141] Figure 3A is a schematic side cross-sectional view of a proximal portion of the core assembly shown in Figure 2, according to some modalities.
[00142] Figure 3B is a schematic side cross-sectional view of a proximal portion of the core assembly shown in Figure 2, according to some modalities.
[00143] Figure 4A is a schematic side cross-sectional view of an embodiment of a core assembly.
[00144] Figure 4B is a schematic side cross-sectional view of another embodiment of a core assembly.
[00145] Figure 5A is a schematic side cross-sectional view of a distal portion of the core assembly shown in Figure 2, according to some embodiments.
[00146] Figure 5B is a schematic side cross-sectional view of another embodiment of a distal portion of the core assembly shown in Figure 2.
[00147] Figure 5C is a rear perspective view of yet another embodiment of a distal portion of the core assembly shown in Figure 2.
[00148] Figure 6 is a schematic side view of the core assembly of the system of Figure 1 in which the stent is not shown, according to some modalities.
[00149] Figure 7A is a schematic cross-sectional view of the system in Figure 1, in which a stent was initially expanded against a vessel wall and a distal cover of the system is disengaged, according to some modalities.
[00150] Figure 7B is a schematic cross-sectional view of the system in Figure 1, in which the distal cover has migrated to an everted position, according to some modalities.
[00151] Figure 7C is a schematic cross-sectional view,
39/115 of the system in Figure 1, in which the distal coverage migrated to another everted position, according to some modalities.
[00152] Figure 8 is a schematic cross-sectional view of the system in Figure 1, in which the stent was partially expanded against the vessel wall and moved out of a catheter lumen, according to some modalities.
[00153] Figure 9 is a schematic cross-sectional view of the system in Figure 1, in which the stent was retracted or retrained within the catheter lumen after the initial expansion of the stent, according to some modalities.
[00154] Figure 10 is a schematic cross-sectional view of the system in Figure 1, in which the stent and a distal tip assembly of the core assembly have been retracted or retrained within the catheter lumen after the initial expansion of the stent, according to some modalities.
[00155] Figure 11 is a schematic cross-sectional view of the system in Figure 1, in which the stent was expanded and released from the core assembly in apposition with the vessel wall, according to some modalities.
[00156] Figure 12 is a schematic cross-sectional view of the system in Figure 1, in which the core assembly was retracted or received within the lumen of the catheter after releasing the stent, according to some modalities.
[00157] Figure 13A is a schematic cross-sectional view of a stent delivery system positioned at a treatment site adjacent to a vessel bifurcation.
[00158] Figure 13B is a schematic cross-sectional view of the stent delivery system and the treatment site shown in Figure 13A, in which a distal portion of a core member of the stent delivery system has been rotated to avoid rubbing or drilling
40/115 a vessel wall, according to some modalities.
DETAILED DESCRIPTION [00159] In the detailed description that follows, numerous specific details are set out to provide a complete understanding of the technology in question. It must be understood that the technology in question can be practiced without some of these specific details. In other circumstances, well-known structures and techniques have not been shown in detail so as not to obscure the technology in question.
[00160] Various modalities of stent delivery systems are described in this document that exhibit small cross-sections that are highly flexible and can provide advantages such as allowing the clinician to recapture, fold, remove, or re-arrange and reposition a partially expanded stent, avoid rubbing or perforating the vessel during placement, place several stents (eg, telescopes) without removing the microcatheter, and / or avoid twisting and rebounding efforts that may occur during stent delivery. The other features and varied advantages of modalities are discussed and shown in this document.
[00161] In some embodiments, a stent delivery system that may include a core assembly and an introducer sheath and / or catheter is provided, the core assembly may comprise a stent that extends through, is conducted, or supported by a core member. The core member may comprise a core yarn. The core assembly can be movable within the introducer sheath and / or catheter in order to deliver the stent to a predetermined treatment site, such as an aneurysm, within a patient's vasculature. Thus, prior to stent delivery, the catheter can be configured to be introduced and advanced through the patient's vasculature. The catheter can be made of various thermoplastics, for example,
41/115 polytetrafluoroHeno (PTFE or TEFLON®), fluorinated propylene ethylene (FEP), high density polyethylene (HDPE), polyether ether ketone (PEEK), etc., which can optionally be aligned on the inner surface of the catheter or on a surface adjacent with a hydrophilic material such as polyvinylpyrrolidone (PVP) or some other plastic coating. In addition, any surface can be coated with different combinations of different materials, depending on the desired results.
[00162] The stent may take the form of a vascular occlusion device, a revascularization device and / or an embolization device. In some embodiments, the stent can be an expansive stent! made of two or more filaments. The filaments can be formed from known flexible materials that include memory-shaped materials, such as nitinol, platinum and stainless steel. In some embodiments, the filaments may be round or oval yarn. In addition, the filaments can be configured in such a way that the stent is self-expanding. In some embodiments, the stent can be manufactured from platinum / 8% tungsten and 35N LT alloy wire (nickel cobalt alloy, which is a low-titanium version of MP35N alloy). In other embodiments, one or more of the filaments may be formed by a biocompatible metallic material or a biocompatible polymer.
[00163] The yarn filaments can be braided within a structure similar to the resulting net. In at least one modality, during the braiding or winding of the stent, the filaments can be braided using a pattern 1 above 2 below 2. In other modalities, however, other methods for braiding can be followed, without depart from the scope of the revelation. The stent may exhibit a porosity configured to reduce hemodynamic flow within and / or induce thrombosis within, for example, an aneurysm,
42/115 but simultaneously allows perfusion to an adjacent branched vessel from which the ostium is crossed by a portion of the stent. As will be noted, the porosity of the stent can be adjusted by wrapping the stent during disposal, as is known in the art. The ends of the stent can be cut to length and therefore remain free for radial expansion and contraction. The stent can exhibit a high degree of flexibility due to the materials used, the density (that is, the porosity) of the filaments and the fact that the ends are not attached.
[00164] Information regarding additional modalities, resources and other details of the occlusion devices or stents, methods of use and other components that can be used or optionally implanted in modalities of the occlusion devices or stents described in this document, can be found in copendent patent applications from claimants No. 12 / 751,997, filed March 31, 2010; 12 / 426,560, deposited on April 20, 2009; 11 / 136,395, deposited on May 25, 2005; 11 / 420,025, deposited on May 24, 2006; 11 / 420,027, deposited on May 24, 2006; 12 / 425,604, filed on April 17, 2009; 12 / 896,707, filed on October 1, 2010; 61 / 483,615, deposited on May 6, 2011; 61 / 615,183, filed on March 23, 2012; 61 / 753,533, entitled Methods and Apparatus for Luminal Stenting, filed on January 17, 2013; 13 / 614,349, entitled Methods and Apparatus for Luminal Stenting, filed on September 13, 2012; and 13 / 664,547, entitled Methods and Apparatus for Luminal Stenting, filed on October 31, 2012; the totality of each of which is incorporated by reference in this document.
[00165] For example, in some modalities, the occlusion device or stent may be a self-expanding stent made of two or
43/115 more filaments of oval or round thread. The filaments can be formed from flexible materials that include biocompatible metals or alloys, such as nitinol, platinum, platinum-tungsten, stainless steel, cobalt-chromium, or cobalt-nickel. In some embodiments, the occlusion device or stent can be manufactured from a first plurality of platinum / 8% tungsten filaments and a second plurality of 35N LT filaments (nickel cobalt alloy, which is a low grade version) alloy titanium MP35N). In other embodiments, one or more of the filaments may be formed by a biocompatible metallic material or a biocompatible polymer.
[00166] The core member can be flexible enough to allow the stent delivery system to curve and adapt to the curvature of the vasculature as needed for axial movement of the stent within the vasculature. The core member can be made of a conventional guidewire material and have a solid cross-section. Alternatively, the core member can be formed by a hypotube. The material used for the core member can be any of the known guidewire materials that include superelastic metals or memory-shaped alloys, for example, nitinol. For example, the core member, along its length or at least at its distal end or tip, may comprise polytetrafluoroethylene (PTFE or TEFLON®). Alternatively, the core member can be formed from metals such as stainless steel.
[00167] In one or more modalities, the stent delivery system can exhibit the same degree of flexion along its entire length. In other embodiments, however, the stent delivery system may have two or more longitudinal sections, each with different degrees of flexion or stiffness. Different degrees of flexion for the stent delivery system can be created using different materials and / or thicknesses within different longitudinal sections
44/115 of the core member. In another embodiment, the flexion of the core member can be controlled by spaced cuts (hand shown) formed within the core member. These cuts can be spaced longitudinally and / or circumferentially from one another. [00168] In some embodiments, the core assembly may attach, capture, or engage with a proximal end of the stent to facilitate recapture, retraction, withdrawal, or retraining of the stent within the catheter lumen. the core assembly can optionally comprise a constricting member or containment sheath. In addition, the core member of the core assembly may additionally comprise at least one projecting member or portion of variable diameter disposed along the length of the core member that can cooperate with the constricting member or containment sheath to secure, grasp or engage the stent in a fit by pressure, abrasion or interference. Accordingly, in some modalities, the constricting member and the projecting member can cooperate to form a grasping mechanism that engages a first or proximal portion of the stent. The gripping mechanism can secure or engage the first portion of the stent in a folded or expanded state [00169] For example, the containment sheath can be movable in relation to the core member and configured to receive a first or proximal end of the stent. When assembled, the stent can extend over the core member with a proximal portion of the stent that extends over a variable diameter portion of the core member and the proximal end of the stent received axially within a distal end of the containment sheath. The distal end of the containment sheath and the variable diameter portion of the core member can be axially spaced or displaced from one another. The spacing of the distal end of the sheath
45/115 contention and the variable diameter portion of the core member can be configured to create a fit by pressure, abrasion or interference with the stent that extends between them in order to secure, capture, retain or engage the proximal portion of the stent. Accordingly, the variable diameter portion or projecting member of the core member can cooperate with the containment sheath or the constricting member to inhibit the expansion of the first or proximal portion of the stent.
[00170] In some embodiments, the proximal portion of the stent can be secured, gripped, retained, maintained or engaged in a folded or unexpanded state. In addition, in some embodiments, the proximal portion of the stent may be attached or engaged in a manner that induces a change in diameter in the proximal portion of the stent. For example, the proximal portion of the stent may extend over or be seated on the variable diameter portion of the core member while a section of the proximal portion of the stent is axially disposed within the distal end of the containment sheath, a session which is driven a diameter size smaller than the diameter size of the proximal portion that extends over or sits on the variable diameter portion of the core member. In addition, in some embodiments, the distal end of the containment sheath may be contiguous with a portion of the stent's diameter change, thereby creating a fit by pressure, abrasion or interference.
[00171] In some embodiments, the variable diameter portion of the core member may comprise one or more steps and / or projections that extend axially. The variable diameter portion can be formed as an integrated structure of the core member (for example, the core member and the variable diameter portion can be formed of a single continuous piece of material). However, the portion of variable diameter can be a separate structure that is
46/115 each, coupled, and / or fixed to the core member. Additionally, in some embodiments, the variable diameter portion can be fixed in relation to the core member. In other embodiments, the portion of variable diameter may be movable longitudinally or liable to rotate in relation to the core member.
[00172] For example, the variable diameter portion may comprise a cylindrical structure or support member that is configured to rotate around the core member, but can be fixed in a longitudinal position (or have a limited range of longitudinal movement) in relation to the core member. Consequently, in some embodiments, the variable diameter portion may facilitate stent rotation. Normally, during delivery of the stent to the treatment site, passing through tortuous vessels can induce a torsional strain on the delivery system and / or the stent. However, in some embodiments, a portion of variable diameter (preferably cylindrical) that can be rotated can support the stent and allow the stent to rotate around the core member, thus relieving torsion efforts during delivery. Such a swiveling variable diameter portion can therefore reduce or eliminate the tendency of the stent to bounce when released or expanded. Ricochet is the rapid spinning unwinding that sometimes occurs when the stent is released due to the release of torsional forces that were exerted on the stent during delivery. Additionally, the rotatable variable diameter portion can also allow the core assembly to exhibit greater flexibility during delivery of the stent to the treatment site.
[00173] Additionally, a gripping or engaging of the proximal portion of the stent may allow a clinician to exert a distal impulse force on the stent to distally advance the stent in relation to the catheter, as well as exert a proximal traction force on the stent to extract
47/115 proximally or retract the stent into the catheter, even after the entire stent has been moved distally beyond a distal end of the catheter and partially expanded in an apposition to a vessel wall.
[00174] Indeed, after navigating the core assembly along the length of the catheter to the treatment site within the patient, the stent can be disposed of the catheter in a variety of ways. In one embodiment, the catheter can be retracted while maintaining the position of the core member to expose the distal end of the core member and the distal end of the stent. While this is done, the stent can be engaged in a collapsed state at least at the proximal end or portion thereof. In some embodiments, the stent may be attached to both the distal and proximal ends or portions thereof while the catheter is retracted.
[00175] For example, the catheter can be extracted proximally in relation to the core assembly, which thus exposes a tip assembly distal from the core assembly. The distal portion or assembly of the core assembly may comprise a distal tip structure and / or a flexible distal cover.
[00176] The distal tip structure can comprise at least one member or component that can be transported by the core member. In some embodiments, the at least one member can be oriented generally across or parallel to the core member. For example, the tip structure may comprise a spiral (s), a band (s) that circumferentially extend material, a clamp (s) and / or other structures that can pass smoothly into a vessel in the distal portion of the core member. In addition, the at least one member can comprise at least one segment of the spiral or other structure.
[00177] In some modalities, the distal coverage may cover or
48/115 at least partially surround a distal end of the stent that extends over an intermediate portion of the core assembly in a first winding, delivery, or pre-expansion position. For example, in this position, the core assembly can be positioned axially within the lumen of the catheter so that the distal end of the stent is positioned axially adjacent to the distal end of the catheter with at least a portion of the distal cover that extends into a space inside the catheter lumen radially between the distal end of the catheter and at least one of the stent or the intermediate portion of the core assembly. The distal coverage may extend proximally to the distal or assembly portion and the space between the distal portion and the catheter. Additionally, in some embodiments, at least a portion of the distal cover may be positioned out of a space radially between the distal tip structure of the core assembly and the catheter. Consequently, in some embodiments, the distal cover may comprise one or more strips of a flexible and / or oily material that can be positioned radially between portions of the distal end of the stent and the inner surface of the catheter to reduce sliding friction between the mounting of nucleus and the catheter.
[00178] However, as the distal end of the stent is drawn or moved beyond the distal end of the catheter lumen, the distal end of the stent can begin to expand and thereby drive the distal coverage of the first winding, delivery or position pre-expansion or configuration to a second position or configuration rolled out, expanded, when re-flushed or everted. As the distal cover moves to the everted position or configuration, the distal end of the stent can be expanded in apposition with the vessel wall. If the stent is deposited in the correct position inside the vessel, the rest of the stent can be drawn, eg
49/115 pandited and released into the target vessel.
[00179] However, according to some modalities, after the stent has been partially expanded and even if the stent has been completely drawn or moved beyond a distal end of the oateter, the stent delivery system can allow the clinician to recapture, collapse, retract or retrain the stent inside the oateter and then dispose, expand or draw again from the catheter. As noted above, some modalities allow the stent to be attached, captured, or proximally engaged by the core assembly to either exert a distal pushing force on the stent or exert a proximal traction force on the stent. Thus, even when the stent is drawn or moved completely beyond a distal end of the catheter, a proximal end of the stent can remain attached, captured, or engaged with the core assembly to allow the stent to be retracted or removed proximally into the catheter until the entire length of the stent has been repackaged into the catheter. According to some modalities, the distal cover can be retracted or removed inside the catheter in the second position or unrolled, expanded configuration, when it is reshaped or everted.
[00180] For example, while the stent is retracted or withdrawn into the catheter, the distal cover can be positioned out of space radially between the catheter and at least one of the stent or the intermediate portion to provide clearance between them and facilitate re-routing to retract the stent and set up the nucleus inside the catheter Additionally, in some embodiments, the distal cover can be positioned in the space radially between the catheter and the distal tip structure of the core assembly. Thereafter, the catheter and / or core assembly can be repositioned axially within the vasculature at a desired location and
50/115 the stent can be drawn, expanded, deposited and released into the vasculature if the placement location is appropriate.
[00181] Therefore, according to some modalities, the distal coverage can facilitate re-routing of the core assembly. The re-routing of the core assembly can be done with or without the stent attached or attached to the core assembly.
[00182] In some modalities, the distal coverage may also facilitate retraction and removal of the nucleus assembly after the stent has been released in the vasculature. As noted, the distal cover can be removed inside the catheter in the second position or unrolled, expanded, when reshaping or everted configuration. Regardless of whether or not the stent was released into the vasculature, the entire nucleus assembly can be removed proximally into the catheter and removed proximally from the catheter. Thus, if the stent has been released into the vasculature, the core assembly can be removed from the catheter and a second core assembly can be inserted into the catheter to provide a second stent at the treatment site. Such modalities can provide significant benefits to a clinician, including, for example, that the catheter does not need to be removed and removed from the vasculature to have a first or subsequent stent at the treatment site. Consequently, the vasculature does not need to undergo additional effort and the operation can be performed with greater speed and efficiency.
[00183] The stent delivery system can also optionally include a steerable tip mechanism or steerable tip assembly. The steerable tip mechanism can allow a clinician to avoid abrasion or perforation of the vessel wall during the procedure. In some embodiments, the steerable tip mechanism may comprise a steerable thread having a curvilinear distal end. For example, a core member of the mount
51/115 core gem can be configured to be targetable as it can be rotated in relation to a projecting member (if present) and the stent, catheter and / or other components of the stent delivery system. The core member may comprise a core yarn. In addition, the core wire may comprise a curved or arcuate distal section that can be rotated or reoriented to point the core wire in a desired direction by turning the core wire. Consequently, in some embodiments, rotation of the core member in relation to the stent may allow the clinician to avoid dislodging the stent from the vessel wall after the initial expansion of the stent and also prevents abrasion or perforation of the blood vessel.
[00184] For example, in some modalities, the stent can extend over a projecting member of the nucleus member and if trapped between the projecting member and a constricting member. The projecting member can be rotatable coupled to or supported on the core member so that the core member is rotatable in relation to the stent, the projecting member and the constricting member. Consequently, rotation of the core member can allow a clinician to adjust the position or orientation of a terminating or distal portion of the core member. Additionally, in some embodiments, the distal portion of the core member may be formed in an arcuate or curved configuration to allow the core member to conform to tortuous vessel geometries. For example, the distal portion of the core member may comprise a curled, curved or arched tip that extends distally from the core member and is oriented transversely to or folds away from a central geometric axis of the catheter lumen.
[00185] Therefore, if the treatment site is adjacent to a tortuous vessel location (for example, a sharp curve in the vessel) or a bifurcation, for example, the clinician can select or control
52/115 the direction in which the core member extends to avoid abrasions or perforations of the vessel during expansion and delivery of the stent at the treatment site.
[00186] For example, before or during drawing of the stent at the treatment site, the clinician can observe the position of the distal tip assembly of the nucleus member in relation to the surrounding vasculature. As the stent expands during the disposition process, it can generally shorten, which requires that or causes the core assembly to include the distal tip assembly to move distally to accommodate the shortening of the stent. This distal movement of the tip assembly may present a danger of abrasion or perforation or a risk that the distal tip may engage the vessel wall in a manner that may create an abrasion or perforation in the vessel. If the clinician can identify a danger of abrasion or perforation, the clinician can assess whether reorienting the tip will allow it to move distally without producing an abrasion or perforation. The clinician can use a proximal actuator of the stent delivery system to rotate the core member, which thus rotates the distal tip of the core member. In some embodiments, the distal tip may have a curved or arched configuration. In some modalities, the arcuate or curved part of the tip may be radiopaque to allow the physician to observe through fluoroscopy or other imaging the orientation of the tip in relation to the surrounding vasculature and to determine whether the tip should be rotated or reoriented in a position where the further distal advancement of the nucleus assembly is less likely to damage the vasculature. Such a position can be one in which the tip points towards a less risky path (for example, at a fork, the softest instead of the sharpest of the turns provided at the fork or the largest vessel instead of the smallest). Thus, a rotation of the distal tip can reorient the direction of the limb
53/115 core to avoid an apex of the bifurcation, a sharp curve in the vessel or other structures of the vasculature that may represent a danger of abrasion or perforation. Subsequently, if the nucleus is advanced axially distally within the vasculature, a properly oriented distal tip can follow the trajectory of the vasculature without abrasion, perforation or otherwise damaging the vessel wall.
[00187] Additionally, in some embodiments, the core assembly of the stent delivery system can be configured to comprise one or more rotatable projecting members mounted on the core member or core wire. The projecting member can be positioned axially adjacent to a distal end of a constricting member that extends over the core member. In some embodiments, the projecting member may have an external cross-sectional profile that is dimensioned at about equal to or greater than the inner cross-sectional profile of the catheter. For example, the projecting member may have an external cross-sectional profile that is dimensioned larger than the inner profile of the catheter.
[00188] Additionally, in some embodiments, the distal tip assembly or structure, for example, which includes the distal cover, can be configured to rotate around the core member. For example, one end of the distal cover can be pivotally coupled with respect to the core member. Thus, the stent can be configured to rotate around the core member at least in part due to the rotatable coupling of the distal cover.
[00189] As observed in a similar way above in other modalities, a stent can extend over the projecting member and be engaged or secured between the projecting member and the constricting member. The stent can have a variable diameter from a first portion to a second portion as the stent is attached to a
54/115 abrasion and / or interference adjustment. The rotatable projecting member can allow the core assembly to exhibit torsion flexibility which can reduce the pushing force required to move the core assembly through the catheter to the treatment site.
[00190] Figures 1 to 6 show modalities of a stent delivery system 100 that can be used to deliver and / or arrange a stent 200 in a hollow anatomical structure like a blood vessel 102. The stent 200 can comprise a proximal end 202 and a distal end 204. Stent 200 may comprise a braided stent or other form of stent such as a laser cut stent, coiled stent, etc. The stent 200 can optionally be configured to act as a flow diverting device for treating aneurysms such as those found in blood vessels that include arteries in the brain or inside the skull or at other locations in the body such as peripheral arteries. The 200 stent can optionally be similar to any versions or sizes of the PIPELINE ™ Embolization Device sold from Covidien of Mansfield, Massachusetts USA. Stent 200 may alternatively additionally comprise any suitable tubular medical device and / or other features as described herein.
[00191] As shown in Figure 1, the stent delivery system 100 shown may comprise an elongated tube or catheter 110 that slidably receives a core assembly 140 configured to load stent 200 through catheter 110. Figure 2 illustrates core assembly 140 without presenting catheter 110 for clarity. The catheter 110 shown (see Figures 1, 5, 7 and 8) has a proximal end 112 and an opposite distal end 114, an inner lumen 116 that extends from proximal end 112 to distal end 114, and an inner surface 118 facing lumen 116. At the distal end 114, catheter 110 has
55/115 is a distal opening 120 through which the core assembly 140 can be advanced beyond distal end 114 to expand stent 200 into blood vessel 102. The proximal end 112 may include a catheter center 122.
[00192] Catheter 110 can optionally comprise a microcatheter. For example, catheter 110 can optionally comprise any of the various lengths of the MARKSMAN ™ catheter available from Covidien of Mansfield, Massachusetts USA. Catheter 110 may optionally comprise a microcatheter that has an internal diameter of about 0.07 cm (0.030 inches) or less and / or an outside diameter of 1 mm (3 French Units) or less near the distal end 114. Instead or in addition to these specifications, catheter 110 may comprise a microcatheter that is configured to percutaneously access the internal carotid artery or a location within the distal neurovasculature of the internal carotid artery, with its distal opening 120.
[00193] Information related to additional catheter modalities 110 and additional details and components that can optionally be used or implanted in the catheter modalities described in this document can be found in Patent Application Publication n-. US 2011/0238041 A1 published September 29, 2011 entitled Variable Flexibility Catheter. The entire publication mentioned above is hereby incorporated by reference into this document and is part of this specification.
[00194] Core assembly 140 may comprise a core member 160 configured to extend generally longitudinally through lumen 116 of catheter 110. Catheter 110 may define a generally longitudinal geometric axis extending between a proximal end and a distal end thereof. As discussed in this document, the distal end of the
56/115 catheter 110 can be positioned at a treatment site within a patient. Core member 160 may comprise an intermediate portion 814 which is the portion of the core member on or over which stent 200 is positioned or extends when core assembly 140 is in the pre-arrangement configuration as shown in Figures 1 to 5B, 13A and 13B. Stent 200 can be fitted into or extended over the intermediate portion of core member 160. Core member 160 may comprise a core wire. Core member 160 may have a proximal end or section 162 and a distal end or end 164. In some embodiments, distal end 164 and / or other portions of core member 160 may be tapered so that core member 164 becomes thinner as it extends distally.
[00195] Core member 160 may be coupled to, terminate at or terminate at a distal end. In some embodiments, the core member 160 may comprise a proximal section and a distal section. The distal section of the core member 160 may be a distal tapered section as illustrated. The distal tapered section may have a gradual cone that continues to the distal tip of the core member 160. [00196] The distal tip of the core member 160 may comprise a distal portion or assembly 180. In some embodiments, the distal tip assembly 180 may comprise a distal tip structure 182 and / or a distal cover 400 or portion that engages a stent. The distal tip structure 182 can comprise at least one member or component that can be carried by the core member 160. In some embodiments, the at least one member can be oriented generally across or parallel to the core member 160. For example , the tip structure 182 may comprise a spiral (s), a band (s) which extends in a circumference manner! material, a clamp (s) and / or other structures that
57/115 can pass smoothly into a vase. In addition, the at least one member can comprise at least one segment of a spiral or other structure.
[00197] In the illustrated embodiment, the core wire can optionally be configured to extend through the distal tip assembly 180 and end at the distal end 164. In some embodiments, the core member 160 can be configured to transmit axial force and torque longitudinal from the proximal end 162 of the core member 160 to the distal end 164 where the distal tip assembly 180 is arranged.
[00198] The distal end 164 of the core member 160 can be a level section of the core member 160. The distal end 164 can be leveled from a cuneiform diameter of the core member 160 for a generally rectangular cross-section having a dimensioned thickness less than the diameter of the adjacent portion of the core member. For example, the distal end 164 may have a thickness between about 0.012 mm (0.0005 inches) to about 0.076 mm (0.003 inches). The distal end 164 can therefore be flush from a distal portion of the core member 160 which has a diameter between about 0.076 mm (0.003 inches) to about 0.12 mm (0.005 inches). In some embodiments, the distal end 164 may be a flat portion having a thickness of about 0.025 mm (0.001 inches). In addition, the length of the flat portion of the distal end 164 can be between about 8 mm and about 15 mm. In some embodiments, the length of the flat portion of the distal end 164 may be between about 10 mm and about 12 mm. Regardless of whether it is in the form of a leveled wire described above or a distally extending spiral tip or other configuration, the distal end 164 can optionally be covered with or include radiopaque material
58/115 as a radiopaque polymer. A suitable radiopaque polymer is a thermoplastic polyurethane (for example, PELLETHANE ™ 80A or TECOFLEX ™) doped with a radiopacifier such as tungsten or barium sulfate.
[00199] As shown in Figures 1 to 2, some embodiments of the core member 160 can be configured with an arcuate or curved distal end 164. The distal end 164 extends distally from the core member 160 and can be oriented transverse to or flexing away from a central axis of catheter lumen 116. The distal end 164 can be curved or flexed to form an angle of approximately 45 degrees with the longitudinal geometric axis of the core member 160. The distal end 164 can be thermoset or otherwise processed to retain an arched / curved / angled configuration. As further discussed in the present document, the core member 160 can be deformed or twisted to rotate the arcuate or curved distal end 164 thereof to advantageously allow a clinician to carefully navigate and guide the distal tip assembly 180 and core member 160 through of tortuous vessel geometry, thus preventing abrasion or perforation of a vessel wall.
[00200] The distal tip assembly 180 can be axially coupled adjacent the distal end 164 of the core member 160. In addition, the core member 160 can extend into and form a core of the distal tip assembly 180 or be connected otherwise the distal tip assembly 180.
[00201] In some embodiments, the distal tip assembly 180 can be rotatable coupled to the distal end 164 of the core member 160. As further discussed in this document, a rotatable coupling between the distal end 164 of the member 160 core and distal tip assembly
59/115
180 may allow core member 160 to rotate independently from distal tip assembly 180 (and possibly other components of core assembly 140). Such relative rotation can advantageously provide better flexibility to the core assembly 140 as it passes through the catheter 110 to the treatment site. In addition, in embodiments in which the distal end 164 of the core member 160 extends distally beyond the distal tip assembly 180, such relative rotation can also advantageously allow the distal end 164 to be rotated independently of the distal tip assembly 180, which can reduce any torsional stress on stent 200, core assembly 140 and / or the surrounding vasculature.
[00202] However, in other embodiments, the distal tip assembly 180 can be rigidly or fixedly coupled to the distal end 164 of the core member 160 so that the distal tip assembly 180 and the core member 160 rotate as one. single unit. For example, core member 160 can be operationally coupled to distal tip assembly 180 so that distal tip assembly 180 is useful for directing or radially orienting core member 160 within catheter 110 and / or a blood vessel through deformation or twist of the core member 160.
[00203] The distal tip structure 182 can be configured to comprise an atraumatic distal end face formed by a round weld bead, especially in embodiments in which the distal end 164 of the core member 160 does not extend distally beyond the distal tip assembly 180. Additionally, distal tip structure 182 may have other atraumatic shapes designed to prevent injury to the vessel into which it may be introduced.
[00204] Core member 160 can be flexible enough to
60/115 allow flexion and bending as it crosses tortuous blood vessels. In some embodiments, the core member 160 may be cuneiform over at least part of its length or contain multiple tapering or angled sections of different diameters or profiles and become narrower and more flexible as it extends in shape. distant.
[00205] Core assembly 140 may also optionally include a proximal retaining member 220 located proximal to stent 200. Proximal retaining member 220 may comprise one or more materials. For example, in some embodiments, the proximal retaining member 220 may include a marker band 222 attached to the core member 160 via a weld bead 224 or other suitable connection. Marking band 222 can be a generally cylindrical structure made of platinum or other radiopaque material. In at least one embodiment, the proximal retaining member 220 can be arranged in the core assembly 140 so that there is a small gap, for example, from about 0.0 mm to about 0.5 mm, axially between the band 222 of the retaining member 220 and the proximal end 202 of the stent 200.
[00206] In modalities in which marker band 222 of the proximal retention member 220 is made of platinum or other radiopaque material / substance visible through fluoroscopy, CAT scan, X-rays, MRi, ultrasound technology or other imaging, a user can be able to determine the location and track the progress of the proximal end 202 of the stent 200 within the catheter 110 or blood vessel 102 by determining the location of the proximal retention member 220.
[00207] Instead of or in addition to the components shown from the proximal retaining member 220, the retaining member 220 may include a marker spiral (not shown) or a spiral or other
61/115 glove (not shown) which has a longitudinally oriented distal open lumen that receives at least partially and surrounds the proximal end 202 and / or another proximal portion of the stent 200. In addition, the proximal retaining member 220 may also comprise an induction member such as a spiral spring wound around core member 160 that can be configured to induce stent 200 in the distal direction.
[00208] Referring now to Figure 3A, some embodiments of system 100 may also comprise a stent retainer assembly 300 configured to releasably engage a proximal portion 206 of stent 200. The stent retainer assembly 300 may allow a clinician to attach , capture or engage the proximal portion 206 of stent 200 in a way that allows the stent to be controlled, positioned and released in a precise and desired position within the vessel. In some embodiments, stent retainer assembly 300 may allow a clinician to push the stent distally, pull the stent proximally, draw or move the stent distally beyond the distal end of the catheter and / or recapture, collapse, withdraw or retrain the stent into the catheter after the stent has been partially expanded into the vessel.
[00209] Additionally, according to some modalities, the stent retainer assembly 300 can be configured to obtain such superior control by using only the grasp, capture or engagement between the stent retainer assembly 300 and the proximal portion 206 of the stent 200. Thus, a distal portion 210 of the stent does not need to go through or directly receive the impulse and traction forces exerted by the clinician. Instead, the distal portion 210 of the stent can be guided by the forces exerted on the proximal portion of the stent and generally expand freely when moved outside the catheter. In this way, the clinician can carefully control the axial position of the
62/115 distal stent placement to properly deposit the stent into the vessel and, if the stent needs to be repositioned, the clinician can recapture, collapse, withdraw or retrain the stent into the catheter and attempt to deposit the stent back into the vessel in the desired position.
[00210] The stent retainer assembly may comprise one or more components that cooperate to secure, capture or engage a portion of the stent 200. In some embodiments, a component attached to, coupled to, carried by or formed in core member 160 may cooperate with other system 100 structures to provide such superior stent control.
[00211] For example, as seen in Figures 2a3A, core assembly 140 may also comprise a constricting member or external grip member 320. Constricting member 320 may have a proximal end 322 and a distal end 324. Constricting member 320 it may comprise an elongated sheath having a central lumen that extends between the proximal end 322 and the distal end 324. The central lumen can be configured to receive the core member 160 therethrough.
[00212] In some embodiments, the constricting member may be a tube or simple sheath. For example, the constricting member can have an internal diameter between about 0.38 mm (0.015 inch) and about 0.58 mm (0.023 inch). The internal diameter can also be between about 0.43 mm (0.017 inch) and about 0.53 mm (0.021 inch). In some embodiments, the inside diameter can be about 0.43 mm (0.017 inch) or about 0.53 mm (0.021 inch). In addition, an external diameter of the constricting member can be between about 0.45 mm (0.018 inch) and about 0.71 mm (0.028 inch). The outside diameter can also be between about 0.50 mm (0.020 inch) and about 0.66 mm
63/115 (0.026 inch). In some embodiments, the outside diameter can be about 0.50 mm (0.020 inch) or about 0.63 mm (0.025 inch). The axial length of the constricting member can also be between about 150 cm and about 200 cm. In addition, the constricting member can be formed of a flexible material. For example, the constricting member can be formed of material such as PTFE, polyimide or the like of such polymers.
[00213] However, the constricting member can also be configured as a structural alternative to a tube or simple sheath. Such structures may include a distal portion end that is completely tubular coupled to a proximal portion that is made of one or more columns or longitudinal threads or that comprises a spiral cut or notched tube. In any of the disclosed constricting members, the distal portion end may comprise a spiral (e.g., a metallic spiral) or other form of retractable sleeve proximally sized appropriately for use in core assembly 140.
[00214] Additionally, the core assembly 140 can also comprise at least one locking member. The blocking member can comprise a projecting or recess disposed along the core member 160. For example, the blocking member can comprise a projecting member or internal handle member 340. The projecting or internal handle member 340 can be a component that extends radially. The projecting or internal handle member 340 can be arranged along the core member 160 between distal section 164 and proximal section 162 thereof. For example, the projecting member 340 can be arranged axially between the proximal section 162 and the distal section of the core member 160. According to some embodiments, the stent retainer assembly 300 can be configured so that the constricting member 320 and the member
64/115 projecting 340 cooperate to secure, engage or capture the proximal end 202 and / or proximal portion 206 of the stent 200. Additionally, the constricting member 320 can be displaced longitudinally in relation to the core member 160 and / or the projecting member 340 to release the proximal portion of the stent and allow it to expand within the vessel. Thus, during axial advancement or withdrawal of stent 200 into lumen 116 of catheter 110 or expansion of stent 200 into the vessel, the proximal portion 206 of stent 200 can be controlled by stent retainer 300.
[00215] In some embodiments, the stent retainer assembly 300 can be configured so that one or more components of the same define a capture area in which at least a portion of the proximal portion of the stent can be attached, engaged or captured. The capture area can extend around at least a portion of the circumference of the core member 160. Consequently, at least a portion of the circumference of the proximal portion of the stent can be attached, engaged or captured in the capture area.
[00216] As shown in Figure 3A, a presented embodiment illustrates that the constricting member 320 can comprise a tube or sheath that receives a portion of the core member 160 in a lumen of the constricting member 320. The distal end 324 of the constricting member 320 can be separated from the core member 160 to define a capture area 350 between them. Capture area 350 in the illustrated embodiment can be formed as a generally cylindrical shaped span configured to receive at least the proximal end 202 of stent 200 within it. Consequently, the distal end 324 of the constricting member 320 can cover at least partially circumferentially or surround at least the proximal end 202 of the stent 200 when the proximal end 202 is received axially within the capture area 350.
65/115 [00217] In some embodiments, a distal portion of the constricting limb can be adjusted over or extended over the proximal end of the stent. As shown in Figures 1 to 3A, a proximal end 202 of stent 200 can be positioned in the lumen of the constricting member 320; preferably the proximal end portion of the stent 200 is lightly compressed radially and rests radially adjacent the inner wall of the constricting member 320. The projecting member 340 can retain the proximal portion of the stent 200 in the constricting member 320. Where the projecting member 340 is located distally from the distal end of the constricting member 320, this can be achieved totally or in part by engaging, closing or capturing the stent 200 between the projecting member 340 and the rim of the distal opening of the constricting member 320. In such embodiments, the stent 200 can be engaged, secured or picked up in a generally axial direction. Where the projecting member 340 is positioned partially or completely within the lumen of the constricting member 320, this can be achieved in whole or in part by capturing the stent 200 between the outer surface of the projecting member 340 and the internal surface of the constricting member 320. In such cases modalities, stent 200 can be engaged, secured or picked up in a generally radial direction. In addition, some modalities can be provided in which stent 200 can be engaged, secured or captured in a direction transversal to the radial and axial directions.
[00218] In certain embodiments, the outer surface of the projecting member 340 can be cuneiform so that its outer diameter increases in a distal direction and the inner surface of the constricting member 320 can be cuneiform to match the tapering of the projecting member 340. In these modalities, stent 200 can be captured between the external surface of the projecting member 340 and the internal surface of the constricting member 320 and / or between the
66/115 projecting member 340 and the rim of the distal opening of the constricting member
320.
[00219] With reference to Figures 1 to 4B and 7 to 10, preferably only a relatively small portion (for example, significantly less than half the length or less than 25% of the length or less than 10% of the length) of the stent 200 is positioned axially within the constricting member 320. In the delivery or catheter configuration shown in Figure 1, the balance of the stent 200 extends distally and somewhat radially outwardly to the distal end 324 of the constricting member 320, preferably resting radially adjacent to the inner surface 118 of catheter 110 except where the distal portion 210 of the stent extends into a distal cover or distal stent cover 400 (discussed further in this document). For example, the axial length of the constricting member extending over the stent can be between about 4 mm and 15 mm. The axial length of the constricting member that extends over the stent can also be between about 6 mm and 10 mm. In addition, in some embodiments, the axial length of the constricting member that extends over the stent can be about 8 mm.
[00220] Additionally, in the embodiment of Figure 3A, the retaining member 220 is shown in dotted lines to illustrate that this component can optionally be included in some embodiments of the stent retaining assembly 300. The gripping, gripping or engagement of the proximal portion 206 stent 200 can be obtained with or without the use of retention member 220. However, in some embodiments, retention member 220 can provide a proximal limit for stent migration and tends to ensure that stent 200 does not migrate proximally as constricting member 320 is moved proximally to the projecting member 340 when stent 200 is released.
67/115
Retaining member 220 can be formed integrated with core member 160 by being formed of a single piece of continuous material. However, the retaining member 220 can also be formed separately from and then coupled to the core member 160. In some embodiments, the retaining member 220 can be fixed relative to the core member 160. However, the retaining member 220 also it can be free to rotate and / or slide longitudinally along the core member 160.
[00221] According to some modalities, the blocking or projecting member 340 may extend in a radial direction around at least a portion of the circumference of the core member. The projecting member may have an outer surface that extends radially beyond or is radially separated from an outer surface of the core member. The projecting member can be generally cylindrical, oval or circular in shape. The projecting member can be an annular ring, cylindrical sleeve or other structure. However, the projecting member may also have one or more protrusions that extend radially that do not extend around the entire circumference of the core member. The projecting member can also be configured to extend over at least a portion of the axial length of the intermediate portion of the core member.
[00222] The blocking or projecting member can be formed of a material that can be adjusted by reduction in the core member. The blocking or projecting member can also be configured to comprise one or more materials. For example, in some embodiments, the projecting member may be formed from a material that has 30% BaSO4. The projecting member can define an axial length between about 1 mm and about 5 mm. In some embodiments, the projecting member can define an axial length
68/115 between about 2 mm and about 4 mm. Additionally, in some embodiments, the projecting member can define an axial length of about 2 mm. The projecting member can define an internal diameter between about 0.12 mm (0.005 inch) and about 0.38 mm (0.015 inch). The internal diameter can also be between about 0.22 mm (0.009 inch) and about 0.33 mm (0.013 inch). In some embodiments, the internal diameter can be about 0.15 mm (0.006 inch), about 0.17 mm (0.007 inch) or about 0.27 mm (0.011 inch). In addition, in some embodiments, the projecting member can define an outside diameter between about 0.33 mm (0.013 inch) and about 0.07 cm (0.030 inch). The outside diameter can also be between about 0.48 mm (0.019 inch) and about 0.63 mm (0.025 inch). In some embodiments, the outside diameter can be about 0.35 mm (0.014 inch) or about 0.50 mm (0.020 inch).
[00223] The projecting member can be formed integrated with the core member as a single piece of continuous material. For example, the projecting member may be an enlarged portion of the core member that has a diameter or profile that is dimensioned greater than a diameter or profile of the axially adjacent portions of the core member. However, the projecting member can also be formed separately from and attached to the core member. For example, in some modalities discussed further in this document, the projecting member can be rotatable coupled to the core member. Alternatively, the projecting member can also be fixedly coupled to the core member.
[00224] Additionally, one or more projecting members can be used in some modalities. For example, as shown in Figure 6, core assembly 840 is illustrated with a first
69/115 ro projecting member 844 and a second projecting member 846 positioned along a core member 860. The first and second projecting members 844, 846 can be configured or operate according to the configurations and functions discussed in this document in relation to any of the modalities of the projecting members. In addition, the first and second projecting members 844, 846 can be configured to slide in relation to each other or otherwise cooperate to support the stent in the core assembly 840.
[00225] Referring again to Figure 3A, the projecting member 340 is shown as a radially prominent component that is formed integrally with the core member 160 of a continuous piece of material. The projecting member 340 is a generally cylindrical shaped component that has a proximal section 342. The proximal section 342 may comprise a proximal wall extending in a radial direction upward from the core member 160, an outer circumferential surface that extends generally extends parallel to a longitudinal geometric axis of the core member 160 and / or an edge formed between the proximal wall and the outer circumferential surface. The edge may be round or formed having a generally perpendicular orientation.
[00226] The projecting member 340 may alternatively comprise a component that is separate from the core member 160 (see, for example, Figure 1). Such a projecting member may comprise, for example, a polymer tube or other suitable material that is attached to the core member 160 by adhesives, heat shrinkage or any suitable technique. In one embodiment, the projecting member 340 comprises a polymeric tube surrounding the core member 160 which passes through a lumen of the tube. One or more coils of metallic wire (such as platinum or alloy wire of
70/115 platinum (not shown) can be wound around and welded to the core member 160 and thus interposed between the core member and the polymeric tube to serve as a mechanical lock between them. Preferably, the tube is heat-reduced material such as PET which is heat-reduced on the outer surface of the spiral (s) so that the reduced tube adheres close to the spiral (s) and becomes securely attached to the core member 160. One projecting member 340 that can rotate around and / or move longitudinally along core member 160 can be constructed in a somewhat similar way. In this case, the fundamental spiral (s) can have a luminal inner diameter that is slightly larger than the outer diameter of the core member 160. The desired luminal inner diameter of the spiral can be defined by winding the spiral (s) in a dimensioned mandrel. appropriately. The polymeric tube is then reduced by heat in the spiral (s) (or otherwise joined to it) to form the outer portion of the projecting member 340. The resulting projecting member 340 is then slid over the core member 160 to the desired position thereof where the projecting member can rotate and / or move in relation to the core member. A block (s) can be formed on the proximal and / or distal core member 160 of the rotatable / translatable projecting member 340 to define boundaries for any longitudinal movement of the projecting member and allow it to rotate. Such a lock (s) can be formed in the manner described above for the projecting member fixed with an underlying spiral attached to the core member and a reduced overlying tube, but in an outside diameter somewhat smaller than the projecting member.
[00227] As shown in Figure 3A, The proximal portion 206 of the stent 200 can extend over the projecting member 340 and the proximal end 202 of the stent can extend into the capture area
71/115
350 formed radially between the constricting member 320 and the core member 160. In this embodiment, these components cooperate to form the stent retaining assembly 300 that can secure, engage or grip the proximal end 202 and / or proximal portion 206 of the stent 200. Thus, during axial advancement or withdrawal of stent 200 within lumen 116 of catheter 110 or during expansion of stent 200 within the vessel, the proximal portion 206 of stent 200 can be controlled by stent retainer 300.
[00228] In particular, the projecting member 340 and the constricting member 320 can cooperate to engage, secure or capture stent 200 in a pressure fitting, an interference fitting or a friction fitting as shown in Figures 3A to 4B. The presence of the projecting member 340 may create a slight increase in the diameter of stent 200 axially adjacent to the distal end 324 of the constricting member 320. Thus, the diameter of the proximal end 202 of stent 200 within the capture area 350 may become smaller than the diameter of stent 200 that extends over the projecting member 340. Instead or in addition to these conditions, stent 200 may be in contact with friction with a distal internal surface 331 and / or edge 332 of the side wall of the constricting member 320 and the section proximal 342 of the projecting member 340, which thus secures, engages or captures stent 200 between them.
[00229] Additionally, in some embodiments, the projecting member 340 may have an external profile or diameter that is dimensioned almost equal to or greater than an Interior profile or internal diameter of the lumen of the constricting member 320. The relative dimensioning of the projecting member profiles 340 and the constricting member 320 can be configured so that the projecting member 340 can be positioned axially adjacent to the constricting member 320 to tighten, secure, grasp or engage the proximal portion 206 of stent 200 in
72/115 a press or interference fit. The outer profile of the projecting member 340 can also be configured to be smaller than the inner lumen profile of the constricting member 320 if the stent thickness is sufficient to create interference or otherwise restrict or decrease the movement of the projecting member 340 in or through the lumen of the constricting member 320. For example, a collective external profile of the stent 200 and the projecting member 340 can be dimensioned larger than the interior lumen profile of the constricting member 320. In some embodiments, the collective external profile can be a diameter measured by adding the outer diameter of the projecting member 340 and twice the thickness of the stent 200. However, in other modalities the internal and external profiles (which can be measured as a size or shape of a cross-section of the corresponding component (s) ) may not be circular, comprise one or more radial projectors, or otherwise understand formats that are different from s circular or rounded.
[00230] Additionally, although the modality illustrated in Figure 3A illustrates that stent 200 can be attached, captured or engaged without the projecting member 340 entering the lumen of the constricting member 320, in some embodiments, the projecting member 340 extends into or is received at least partially in the lumen of the constricting member 320.
[00231] Figure 3B illustrates an alternative embodiment of a stent retainer assembly. As noted in this document, the configuration of the core member, locking member and retaining member can be varied according to several modalities. Figure 3B illustrates a stent retainer assembly 300 'in which a locking member is formed as a recess 170 within a body of a core member 160'. The recess 170 may extend circumferentially around the core member
73/115
160 ’to provide a capture area 350’ configured to receive at least a portion of the proximal end 202 ’of stent 200’.
Alternatively, the recess 170 may comprise one or more penetrations in which a portion of the proximal portion 206 'of the stent 200' can be received.
Thus, in the embodiment illustrated in Figure 3B, the core member 160 'can have a generally constant diameter (or a taper diameter) and the recess 170 can be configured to receive at least a portion of a proximal portion of the 200 'stent. The diameter of the core member 160 'can be dimensioned larger along a section of projecting member 340' than along a proximal section that extends within a lumen of a constricting member 320 '. However, the relative diameters of the core member sections 160 'can be varied and configured with respect to the inner diameter or inner profile of the constricting member 320' as discussed in a similar manner above with respect to Figure 3A. Like the modalities discussed above, the stent retainer assembly 300 'can cooperatively engage, secure or grasp a proximal portion 206' of the stent 200 'to provide superior control of the stent 200' during operation.
[00233] With reference again to Figure 2, modalities of the system 100 can be configured so that the constricting member 320 can be removably coupled with respect to the core member 160 through a removable, disengaging or breakable coupling 360 (or selectively) otherwise longitudinally movable, adjustable or retractable with respect to core member 160). The coupling 360 is preferably located near the proximal end 162 of the core member 160 or at another location on the core member that is accessible to the clinician outside the patient's body proximal to the center 122 or another portion of the proximal end of the
74/115 catheter 110. The constricting member 320 can extend distally from a proximal end 322 thereof on the coupling 360 to a distal end 324 which is located slightly proximal to (or overlapping) the projecting member 340.
[00234] A longitudinal or axial position of the constricting member 320 in relation to the core member 160 can be maintained or modified by means of the 360 coupling. The 360 coupling can be located in a proximal location that is outside a lumen body so that a clinician can trigger the 360 coupling or to maintain or change the relative axial positioning of the constricting member 320 in relation to the core member 160. Consequently, in some embodiments, a clinician may disengage or break a connection between the 360 coupling and the constricting member 320 to move the distal end 324 of the constricting member 320 in relation to the core member 160. The clinician can therefore maintain a stent engagement, fixation, or capture by using the stent retainer assembly until the stent is positioned in one location. desired at the treatment site. Once the stent is in the desired location and deposited properly, the clinician can later disengage and release the stent by acting on the 360 coupling to proximally remove the constricting member 320 in relation to the core member 160 (or to allow proximal removal) subsequent limitation of the constricting member).
[00235] Additionally, in some embodiments, the coupling 360 and the constricting member 320 can be configured with one or more locking points along a longitudinal movement range of the constricting member 320 in relation to the core member 160. Such points of blocking can control the relative axial movement between the constricting member 320 and the core member 160, which causes the constricting member to block at one or more locations
75/115 desired. For example, a first locking point can be provided where the constricting member 320 is in an engaged position (for example, where the proximal portion of the stent is captured by the stent retainer assembly 300). The first blocking point can indicate tactfully to the clinician that the constricting member 320 is positioned to capture the proximal portion of the stent. Instead of or in addition to the first blocking point, a second blocking point can be provided that tactfully signals to the clinician that the constricting member 320 has been retracted proximally to the core member 160 and / or the blocking member by a distance that is sufficient to ensure that the stent has been released from the stent retainer assembly.
[00236] The modalities disclosed in this document provide useful advantages. In addition to those discussed in this document, the stent retainer assembly can provide a system with superior flexibility and therefore decreases the delivery force required to advance the system to the treatment site. To some extent, the stent retainer assembly retains a portion of the stent in a collapsed configuration that will tend to decrease the amount of frictional engagement between the stent and the internal surface of the catheter, which further decreases the required delivery force.
[00237] In addition, as further discussed in this document, some modalities may provide a delivery system in which the distal end of the stent automatically expands when exiting the distal end of the catheter, thus eliminating the need for a structure that controls the expansion characteristics of the distal end of the stent. For example, some embodiments disclosed in this document do not require a distal cover that must be rotated or moved in another way to disengage from the distal end of the stent.
76/115 [00238] In addition, modalities of the stent retention structure may allow a clinician to recapture, collapse, retract, or retrain the stent into the catheter after partial expansion of the stent. Even in situations where the entire stent has left the catheter lumen, some modalities of the stent retention structure disclosed in this document may allow the clinician to recapture, collapse, retract or retrain the proximal portion of the stent and, therefore, the entire stent inside the catheter lumen so that the core assembly can be removed entirely or to allow the stent to be repositioned and deposited again at a desired location at the treatment site.
[00239] As noted above, the locking member or the projecting member of the core assembly can be formed integrated with the core member as a single piece of continuous material or formed separately from the core member and coupled thereto. In some embodiments, the projecting member can be swivelably coupled to the core member.
[00240] For example, with reference to Figures 4A to B, alternative modalities of the blocking member or projecting member are shown. As shown in Figure 4A, similar to Figure 3A, a core assembly 600 comprises a constricting member 620, a distal cover 630, a projecting member 640, a core member 660 and a stent 670. The projecting member 640 can be formed of a single piece of continuous material with the core member 660 as discussed above in relation to some embodiments.
[00241] However, Figure 4B illustrates another core assembly 700 comprising a constricting member 720, a distal cover 730, a projecting member 740 and a core member 760. The projecting member 740 is formed separately from the numbered member.
77/115 dec 760. The projecting member 740 can optionally be configured to rotate in relation to the core member 760. Consequently, in the core assembly 700, the core member 760 can freely rotate within the constricting member 720 of the projecting member 740 and stent 770. In some of such embodiments, a distal tip assembly 780 of core assembly 700 can be pivotally coupled to core member 760 which can allow core member 760 to also rotate freely with respect to distal tip assembly 780 instead of or in addition to the projecting member 740 and stent 770.
[00242] In modalities that use a lockable or rotating projecting member, the core assembly can exhibit improved flexibility and also reduce torsion effort on the stent mounted on it. Consequently, while the core assembly is deposited at the treatment site, the rotating freedom of the core member can allow the core member to adjust as it traverses tortuous paths without transferring torque to the stent. This improved turning ability can reduce rebound. In addition, the improved flexibility of the core assembly can also reduce the required delivery force.
[00243] Additionally, in some embodiments, the rotatable limb of the blocking or projecting member can be swiveled coupled with respect to the core member while the distal tip assembly is fixedly coupled with respect to the core member so that the distal tip assembly and the core member rotate as a unit. In such modalities, the turning capacity of the projecting member can be affected indirectly through contact of the stent with the distal tip assembly and the projecting member. Although the stent may not be swiveled in relation to the distal tip assembly, the interaction between the
78/115 distal tip assembly and the stent can create some resistance for rotation of the stent in relation to the core member that would otherwise be freely allowed in the interconnection of the projecting member and the core member. However, once the distal tip assembly exits the catheter and the distal end of the stent is allowed to expand, the core member can rotate freely in relation to the projecting member and the stent.
[00244] According to aspects of some modalities, the blocking or projecting member can also be configured to slide longitudinally in relation to the core member, instead of or in addition to any rotation capacity. For example, the blocking or projecting member and the core member can be configured so that the core member comprises one or more projectors or limits against which the blocking or projecting member can touch to limit longitudinal movement (proximal or distal) of the blocking or projecting member.
[00245] The projecting member preferably comprises a relatively soft or compressible cylindrical member and can be formed from a suitable polymer or elastomer. In some embodiments, the external diameter of the projecting member is preferably small enough in relation to the internal diameter of the catheter to inhibit the projecting limb from uptake or to propel the stent against the inner wall of the catheter and thus generate significant friction between the stent and catheter . For example, as shown in Figure 1, the projecting member 340 can leave sufficient radial space between the external surface of the projecting member 340 and an internal surface or wall 118 of catheter 110 to allow the stent wall to move radially between the projecting member 340 and an internal surface of catheter 118 when it is otherwise unrestricted. Alternatively, the projecting member 340 can be dimensioned and configured to
79/115 capture the stent 200 against the internal surface 118 of the catheter 110. [00246] In the core assembly shown 140, the constricting member 320 and the projecting member 340 can capture the stent 200 to facilitate delivery of the stent 200 through the lumen 116 catheter 110 and a stent 200 retargeting when it is partially expanded while completely or substantially insulating catheter 110 from the uptake forces involved in uptake of stent 200 by core assembly 140. In this way, core assembly 140 can safely capture the proximal end of stent 200 securely balanced enough to facilitate retraining without generating high radial frictional forces between stent 200 and the internal surface 118 of catheter 110 that can prevent the stent from advancing through catheter 110. Instead, only relatively light radial frictional forces can exist between stent 200 and catheter 110 generated by the self-expansion of the stent against internal surface 118, which does not significantly impede the axial advance of stent 200 into lumen 116 of catheter 110.
[00247] It can also be seen that the stent delivery system 100 can grasp stent 200 radially and / or axially between components that do not (or do not need to) move relative to each other during axial movement of the stent within the lumen 116 of catheter 110, thereby reducing the abrasion that can arise between two components (core assembly 140 and catheter 110) that can move relative to each other for a significant distance during delivery of stent 200. Catheter 110 can remain relatively stationary within the patient's vasculature while core assembly 140 and stent 200 are advanced to and / or through the distal end of catheter 110. During this advance, constricting member 320 and projecting member 340 can remain stationary with respect to each other and either one or both remain stationary
80/115 in relation to the 200 stent.
[00248] Structures different from the modalities described in the present document of the constricting member 320 and the projecting member 340 can be used in the core assembly 140 to move the stent 200 along the catheter 110. For example, the constricting member 320 and the projecting member 340 can be omitted and the proximal damper 220 employed for this purpose. Instead of or in addition to shock absorber 220, additional blocks or shock absorbers can be mounted on core member 160 underlying stent 200 and configured to cooperate with radially adjacent portions of the side wall catheter to capture stent 200 and facilitate movement along the catheter 110.
[00249] According to some embodiments, the distal tip assembly of the core assembly may comprise a distal cover configured to reduce abrasion between the stent (for example, the distal portion or distal end thereof) and the internal surface of the catheter. The distal tip assembly can be configured to comprise either one or both the distal tip structure and the distal cover.
[00250] Some modalities can be provided in which the distal coverage provides a restrictive force that assists in maintaining the distal portion of the stent in a collapsed configuration until released by the clinician. However, coverage distal from other modalities disclosed in this document does not, in itself, provide a restraining force to maintain the stent at a collapsed diameter.
[00251] For example, the distal cover can be configured as a flexible oily structure that has a first end or free section that can extend over at least a portion of the stent and / or intermediate portion of the core assembly and a second end or fixed section that can be attached to the
81/115 distal tip and / or the core member at a fixation point. The second section can be coupled directly to the core member or indirectly to the core member, for example, because it is attached to the distal tip structure. The distal cover can have a first position, configuration or orientation or delivery (see, for example, Figures 1, 2, 4A, 4B, 5A, 5B, 6, 13A, 13B) in which the distal cover can extend proximally in relation to the distal tip structure or fixation point and at least partially surround or cover a distal portion of the stent. In addition, the distal cover can be movable from the first orientation or delivery to a second position, configuration or orientation or re-routing (see, for example, Figures 7B to 7C, 8 to 12) in which the distal cover can be placed so that the first end of the distal cover is positioned distally with respect to the second end of the distal cover to allow for re-routing of the core assembly 140 or with the stent 200 retained by the stent retainer assembly 300 or without the stent.
[00252] Figures 5A and 5B reveal modalities of the distal cover 400. The modalities of Figures 5A and 5B can be similar in structure, function and method of use, except for the way in which the cover 400 is fixed to the core assembly 140. Consequently, in the discussion of this 400/400 distal coverage document, any mention of a component that has a numerical reference used in Figure 5A (eg 420) must comprise including the corresponding raw numeric reference used in Figure 5B ( for example 420 ') and to apply with force equal to the component designated in Figure 5B and vice versa.
[00253] With reference to Figures 5A to 5B, core assembly 140 can include distal cover 400 which, as noted above, can be configured to reduce radial abrasion between stent 200
82/115 (for example, distal portion 210 or distal end 204 thereof) and inner surface 118 of catheter 110. Distal cover 400 may include a first section or free end 420 and a second section or fixed end 440. According to illustrated, the second section 440 is coupled Indirectly to the core member 160 through the distal tip structure 182 which is further discussed below. [00254] Additionally, as shown in Figures 5A to 5B, at least a portion of the distal cover 400 may at least partially extend or be interposed radially between the distal portion 210 of the stent 200 and the inner surface 118 of the catheter 110 in the first position , configuration or orientation. In the first orientation, the first section 420 of the distal cover 400 can extend from the second section 440 in a proximal direction to a point where the first section is interposed between the distal portion 210 of the stent 200 and the inner surface 118 of the catheter 110. In this orientation, the first section of the distal cover may assume a proximally oriented position or configuration.
[00255] The core assembly 140 shown in Figures 5A to 5B can operate as shown in Figures 7A to C. With reference to Figures 7A to C, the core assembly 140 can be distally advanced to the distal portion 210 of the stent 200 be positioned distally beyond the distal end 114 of catheter 110 to allow expansion of distal portion 210 of stent 200 into a lumen 104 of blood vessel 102. As the distal portion 210 of stent 200 expands, it can cause distal cover 400 is opened or moved from the first orientation. Because stent 200 can shorten as it expands, stent 200 can be removed from the engagement with distal cover 400 as shown in Figure 7A.
[00256] After the distal cover 400 has been disengaged from the stent 200 to achieve the state shown in Figure 7A, the cover can
83/115 proceed to the second orientation as shown in Figure 7B or 7C as approaching blood flow impels the first section 420 distally. Alternatively, the distal cover 400 can remain substantially in the disengaged distally extending configuration shown in Figure 7A until the core assembly 140 is removed proximally into the catheter 110 at which point the distal end of the catheter 110 can force the first section 420 approaching the cover 400 to everter or otherwise assume the second configuration as shown in Figures 10 or 12. In each case, the distal cover 400 can move towards a position or everted configuration in which the first section 420 of the cover distal 400 is flipped, everted or rotated to extend in a distal direction or in a distally oriented position or configuration. In some embodiments of a second, distally oriented configuration, all or at least a portion of the first section 420 is located distal from all or at least a portion of the second section 440.
[00257] Stent 200 can be additionally drawn (as shown in Figure 8) and subsequently released (as shown in Figure 11), or stent 200 can be retracted and returned into catheter 110 (as shown in Figures 9 to 10) if necessary. In any event, when the distal portion of the core assembly 140 is removed in the lumen of the catheter 110, the distal cover 400 can be retracted into the catheter 110 in the second position, configuration or orientation in which the distal cover 400 can be at least partially everted as shown in Figures 9 to 10 and
12. This can facilitate complete re-routing of stent 200 and / or core assembly 140 within catheter 110.
[00258] In some modalities, in the first orientation, the first section 420 of the distal cover 400 is positioned outside a space
84/115 radial 800 located between tip assembly 180 and catheter 110, as shown in Figure 5. The distal cover 400 can extend proximally from the distal portion or tip assembly 180 and the radial space 800 between the distal portion or tip assembly 180 and catheter 110. Additionally, in some of such modalities, in the second orientation, the first section 420 of the distal cover 400 extends distally through the radial space 800 after retraction of the core assembly 140 inside the catheter 110 , as shown in Figures 10 and 12.
[00259] Additionally, in some embodiments, in the first orientation, at least a portion of the distal cover 400 may extend into a radial space 804 within the catheter lumen 116 located between a distal end 812 of the intermediate portion 814 of the core member 160 and the distal end 114 of the catheter 110. For example, with reference to Figures 5A to B, the first section 420 of the distal cover 400 may extend or be interposed radially between the distal end 812 of the intermediate portion 814 and the inner surface 118 of the catheter 110. Additionally, in some embodiments, in the second orientation, the first section 420 of the distal cover 400 no longer extends or is no longer radially interposed between the distal end 812 of the intermediate portion 814 and the inner surface 118 of catheter 110 (and the first section 420 can be located distally from such a location), after retraction of the core assembly 140 within of catheter 110 as shown in Figures 10 and
12.
[00260] Additionally, in some embodiments, the first section 420 of distal cover 400 may radially overlap distal end 204 of stent 200 at a point of overlap 820 along core member 160. As shown in Figures 5A to B and 12 , the overlapping point 820 can be located along the
85/115 core member 160 proximal to tip assembly 180. In some embodiments, the overlapping point 820 can be spaced about 5 mm to about 12 mm from the proximal end of the distal tip structure 182. In some embodiments, the overlap point 820 can be spaced about 6 mm to about 10 mm from the proximal end of the distal tip structure 182. In addition, in some embodiments, the overlap point 820 can be spaced about 8 mm from the proximal end of the tip structure distal 182. The overlapping point 820 can be located at or near the distal end 812 of the intermediate portion 814 of the core member 160 or at any location along the core member 160 that supports an overlap of the (first section 420 of) the cover 400 over the stent 200 when the core assembly 140 is in the pre-arrangement configuration shown in Figures 1 to 5B and 13A to 13B. Additionally, in some of these modalities, in the second orientation, the first section 420 of the distal cover 400 no longer overlaps (the distal end 204 of the) stent 200 at the overlapping point 820 (and the first section 420 can be located distally from such location) after retraction of core assembly 140 into catheter 110 as shown in Figures 10 and 12.
[00261] In the second orientation, as shown in Figures 7A to 8, there is no longer a radial overlap of the stent 200 and the cover 400 at the overlap point 820 or at the distal end 812 of the intermediate section 814. Thus, after disengaging the distal cover 400 from stent 200, core assembly 140 can be extracted proximally into catheter 110 and distal cover 400 will generally extend in a distal direction away from overlapping point 820. As also shown in Figures 9 to 10, in such a time that the 200 stent is either reshaped or removed from within the
86/115 catheter 110 after partial expansion, stent 200 and distal coverage 400 will not overlap at overlapping point 820. Thus, distal coverage 400 will not overlap stent 200 or overlapping point 820 after at least partial expansion of the stent 200 when the core assembly 140 is removed from inside the catheter 110. Additionally, since the distal cover 400 is disengaged, the intermediate portion 814 of the core member 160 can be positioned radially adjacent to the distal end 114 of the catheter 110 with the distal cover 400 being positioned outside the radial space 804 between the intermediate portion 814 and the catheter 110. Consequently, the movement and configuration of the distal cover 400 can allow the core assembly 140 to provide radial clearance between the core member 160 or intermediate portion 814 and catheter 110 to facilitate retargeting of core member 160 as shown in Figures 9 to 10 and 12.
[00262] The distal cover can be coupled in relation to the core member. The distal cover can be attached to the core member and / or to the tip assembly 180 of the core assembly. In some embodiments, the distal cover can be threaded in a spiral of the tip assembly 180. In the embodiment shown in Figure 5A, the distal cover 400 can be coupled directly to the distal tip structure 182 and indirectly coupled to the core member 160. In the embodiment of Figure 5A, the distal tip structure 182 is rigidly coupled to the core member 160. However, the distal tip structure 182 can also be movable with respect to the core member 160 to provide relative rotation or sliding along the member of the core. core 160 as discussed below in relation to Figure 5C.
[00263] For example, distal cover 400 and / or distal tip structure 182 can be configured to rotate around core member 160. For example, one end of distal cover 400
87/115 can be pivotally coupled with respect to core member 160. Thus, stent 200 can be configured to rotate around core member 160 at least in part due to the rotatable coupling of distal cover 400. Consequently , in some embodiments, the stent can rotate relative to the core member 160 while minimizing any torsional stresses on the stent.
[00264] In the embodiment of Figure 5A, the distal cover 400 comprises a reduction tube 460 configured to reduce and adhere to the second section 440 to the distal tip structure 182. Alternatively, the second section 440 of the distal cover 400 can be coupled to the structure distal edge 182 through other fixing devices or means which include, but are not limited to, mechanical fasteners, welding techniques, adhesives, hot bonding and combinations thereof or the like. In yet another embodiment, the second section 440 can be coupled directly to a distal portion or to the distal end 164 of the core member 160 itself by using any suitable fixation.
[00265] In some embodiments, the distal tip structure 182 may comprise at least one member that may have the orientation, in general, transversal or parallel to the core member. For example, the tip structure 182 may comprise a spiral (s), a circumferentially extending band (s) of material, a clamp (s), and / or other structures that can smoothly pass through the interior of a vessel in the distal portion of the nucleus member. Furthermore, the at least one member can comprise at least one segment of the spiral or other structure. According to some embodiments, the distal cover 400 can be coupled to the distal tip structure 182 by virtue of the formation of a wrapper that involves at least one member. For example, the distal cover 400 can form a wrapper that involves at least one spiral segment
88/115 of the distal penta structure 182 because it curls, at least partially, around the segment.
[00266] Figure 5B illustrates another embodiment of a core assembly 140 '. The core assembly 140 'comprises a core member 160', a distal tip assembly 180 '(which has a distal tip structure 182' in the form of a spiral) and a distal cover 400 '. The distal cover 400 'comprises a first free section 420' and a second fixed section 440 '. The second section 440 'is attached to the spiral of the distal tip structure 182' by passing or being looped between adjacent windings of the spiral (or otherwise through one side of the spiral or around one or more windings of the spiral ), as illustrated. The second section 440 'may comprise a looped portion 442' that extends between the adjacent spiral windings and, proximally, back in contact with another portion of the second section 440 '. The overlapping aspects of the looped portion 442 'and the second section 440' can be fused or otherwise joined or adhered to each other to securely secure the distal cover 400 'to the distal tip structure 182'. The other components of the core assembly 140 'and catheter 110' are labeled similarly to Figure 5A, as shown.
[00267] Figure 5C is a rear perspective view of a distal cover 400. The distal cover 400 can be similar in terms of structure, function and method of use to distal cover 400 (for example, as shown in Figure 5A) and / or the distal cover 400 '(for example, as shown in Figure 5B), however, with additional or replaced structures, functions and uses as described in this document. The distal cover 400 can be used in place of the distal covers 400/400 'in the construction of any modality of the core assembly 140. The distal cover 400 can be coupled to a distal tip assembly 180 in a similar manner as illustrated.
89/115 in Figure 5B. However, in this embodiment, the distal tip assembly 180 comprises a distal tip structure 182 that is longitudinally movable and / or liable to rotate in relation to the core member 160 ”.
[00268] In some embodiments, the core member 160 may comprise a proximal lock 430 and a proximal lock 432. Proximal lock 430 and proximal lock 432 ”can be configured to limit the sliding movement range of the distal tip structure 182. The proximal lock 430 and the proximal lock 432 can be separated from each other along the core member 160 by a distance that allows longitudinal movement of the tip structure 182 in relation to the core member 160. In some embodiments, the locks 430, 432 do not substantially allow any longitudinal movement of the tip structure 182 and cover 400, however, allow these components to rotate around the core member 160. The distal tip structure 182 may comprise an internal lumen that receives the limb from core 160 itself in such a way that the distal tip structure 182 can slide and / or rotate relative to the core member 160. For example, some embodiments of the distal tip structure 182 may comprise a spiral. In this way, the distal cover 400 can rotate and / or slide in relation to the core member 160. Such movement can allow the distal cover 400 to move or rotate with the stent during delivery to reduce the strain and pushing force as required. core assembly 140 passes through the patient's vasculature.
[00269] The distal cover may be one or more strips, wings, or elongated portions that are coupled to the tip assembly and / or core member of the core assembly. In some embodiments, the distal covering does not comprise more than two elongated strips, wings, or elongated portions. The strips, wings, or portions elongate
90/115 das can be formed as separate components that are coupled to the core assembly. In addition, strips, wings, or elongated portions can also be formed from a single continuous piece of material that is coupled to the core assembly. The strips, wings, or elongated portions may have first free ends, as well as second ends that are coupled to the core assembly. The first free ends can cover at least a portion of the distal stent portion during stent delivery. Furthermore, when the core assembly is removed proximally into the catheter, the strips, wings, or elongated portions may be extroverted, such that the first free ends of the strips, wings, or elongated portions are attracted together in a distal manner. to the second ends.
[00270] For example, the distal cover can be produced or otherwise cut from a tube of the material selected for the distal cover. As shown in Figures 5 to 6, in some embodiments, the first section 420 can be formed according to multiple longitudinal strips cut from the tube and the second section 440 can be an uncut length of the tube. Consequently, the second tubular section 440 and the strips proximally extending from the first section 420 can form a unique integral device or structure.
[00271] In some embodiments, the distal cover 400 may comprise a tube and the first section 420 may include two or more portions of strips or semi-cylindrical or partially cylindrical tubes separated by a corresponding amount of longitudinally oriented, generally parallel cuts, or separations formed or otherwise positioned on the side wall of the tube. Therefore, when in the pre-expansion state, as shown in Figures 1, 2, 4, 5 and 6, the first section 420 can generally have the
91/115 shape of a longitudinally divided or longitudinally notched tube that extends or interposes radially between the outer surface 208 of stent 200 and the inner surface 118 of catheter 110.
[00272] In various embodiments, the strips, wings, or elongated portions of the first section 420 can collectively span substantially the entire circumference of the outer surface 208 of the stent 200 (e.g., where the cuts between the strips are substantially width divisions zero), or be dimensioned somewhat smaller than the entire circumference (for example, where the cuts between the strips are notches that have a non-zero width). According to some embodiments, the width of the strips, wings, or elongated portions of the first section 420 can be between about 0.5 mm and about 4 mm. The width can be about 0.5 mm to about 1.5 mm. According to some modalities, the width can be about 1 mm.
[00273] The strips, wings, or elongated portions of the first section 420 can also extend longitudinally over at least a portion of the distal portion of the stent. In some embodiments, the first section 420 may extend between about 1 mm and about 3 mm over the distal portion of the stent. In addition, the first section 420 can also extend between about 1.5 mm and about 2.5 mm over the distal portion of the stent. According to some modalities, the first section 420 can extend about 2 mm over the distal portion of the stent.
[00274] The first section 420 and the second section 440 can define a total length of the distal cover 400. In some embodiments, the total length can be between about 4 mm and about 10 mm. The total length can also be between about 5.5 mm and about 8.5 mm. In some embodiments, the total length can be about 7 mm.
[00275] The strips of the first section 420 can be of size
92/115 substantially uniform. For example, the first section 420 may comprise two strips that span approximately 180 degrees each, three strips that span approximately 120 degrees each, four strips that span approximately 90 degrees each, or otherwise be divided to collectively cover all or part of the stent circumference, etc. Alternatively, the strips can be differentiated in angular dimension and coverage area without departing from the scope of the development. In one embodiment, only two portions of strips or tube are employed in the first section 420. The use of only two strips can facilitate radial expansion, distal movement and / or bending over or eversion of the first section 420, as discussed in this document, while while minimizing the amount of free or non-contained strips in the blood vessel lumen and any potential for injury to the vessel due to contact between a strip and the vessel wall.
[00276] According to some modalities, at the distal end 204 of the stent 200 or close to it, the first section 420 of the distal cover 400 can be configured to everter or, otherwise, to fold over and / or to the inside of itself even so that it therefore creates a folded portion 480 that extends or interposes radially between the outer surface 208 of stent 200 and the inner surface 118 of catheter 110, as shown in Figures 5A to B. As shown, the folded portion 480 may have an outer layer 482 and an inner layer 484, wherein the outer layer 482 is radially adjacent to the inner surface 118 of catheter 110 and the inner layer 484 is radially adjacent to the outer surface 208 of stent 200. In such embodiments, the configuration of the inner layer 484, which is radially adjacent to the outer surface 208 of stent 200, can advantageously facilitate expansion of stent 200 due to the fact that stent 200 would not be needed air slide along the
93/115 inner layer 484. Instead, inner layer 484 can ever change as the stent expands so that it therefore reduces any friction between stent 200 and distal cover 400.
[00277] Furthermore, in some embodiments, the distal cover 400 can be configured to fold over itself in a manner opposite to that shown in Figures 5A to B, such that layer 482 is the inner layer and layer 484 is the outer layer. In other embodiments, the first section 420 is not folded, everted, or not at all, when in the first configuration or pre-expansion configuration.
[00278] The distal cover can be produced using a lubricating and / or hydrophilic material such as PTFE or Teflon®, however, it can be produced from other suitable lubricating materials or lubricating polymers. The distal cover may also comprise a radio-opaque material. For example, one or more Teflon® strips can be coupled to the distal core member or tip structure to form the distal cover. The distal cover can define a thickness of between about 0.01 mm (0.0005) and about 0.08 mm (0.003). In some embodiments, the distal cover may be one or more strips of PTFE that have a thickness of about 0.03 mm (0.001). The material of the distal cover can also be fixed by means of another material, such as the retractable tube 460, fitted around the perimeter of the distal cover. The retractable tube 460 can define a radial thickness of between about 0.03 mm (0.001) and about 0.05 mm (0.002). In some embodiments, the radial thickness of the retractable tube is about 0.04 mm (0.0015) (based on a tubular shape that has an inside diameter of about 0.41 mm (0.016) and an outside diameter of about 0.48 mm (0.019)). Thus, a radial spacing between the distal cover (when everted) and the internal surface of the catheter can be about 0.05 mm (0.002) and about
94/115 0.1 mm (0.004).
[00279] When the tube assembly 140 is removed, as shown in Figures 10 or 12, the distal cover 400 may extend distally through the annular space between the distal tip of the core member 160 and the inner surface 118 of the catheter 110 and provides a gap between them. The spacing between the inner surface 118 and the distal cover 400 (when pushed against the distal tip of the core member 160) can be equal to or greater than the spacing between the outer surface of the constricting member 320 and the inner surface 118 of the catheter 110. so, as noted above, if the internal diameter of catheter 110 is about 0.76 mm (0.030) and the outside diameter of the constricting member 320 is about 0.64 mm (0.025), the spacing between the internal surface 118 and distal coverage 400 would be at least about 0.06 mm (0.0025). Furthermore, as also noted in this document, the outer diameter of the distal tip structure 182 can be about 0.38 mm (0.015).
[00280] In operation, the distal cover 400, and in particular the first section 420 or the folded portion 480, can generally cover and protect the distal end 204 of stent 200 as stent 200 is moved distally to the inside of catheter 110. The distal cover 400 can serve as a support or cushioning layer that, for example, inhibits the filament ends 212 of the distal end 204 of the stent 200 (shown schematically in Figures 5A-B) from contact with the internal surface 118 of catheter 110, which could damage stent 200 and / or catheter 110, or otherwise compromise the structural integrity of stent 200. Since the distal cover 400 can be produced from a lubricating material, the distal cover 400 may exhibit a low coefficient of friction that allows the distal end 204 of stent 200 to slide axially
95/115 inside the catheter 110 with some ease. The coefficient of friction between the distal cover and the internal surface of the catheter can be between about 0.02 and about 0.4. For example, in the modalities in which the distal cover and the catheter are formed from Teflon®, the friction coefficient can be about 0.04. Such modalities can advantageously improve the ability of assembling the pass-through core through the catheter, specifically in tortuous vasculature. [00281] Structures in addition to the modalities described in this document of distal coverage 400 can be used in core assembly 140 to cover the distal end of stent 200. For example, a protective spiral or other glove that has a lumen proximally open , longitudinally oriented, can be used. Suitably, the protection spirals include those disclosed in Patent Application Publication No. U.S. U.S. 2009/0 318947 A1.
[00282] Furthermore, as also noted in this document, some modalities can be configured in such a way that the distal tip assembly (for example, the distal tip structure 182) is movable in a way that can be rotated and / or axial in relation to to the core member 160. Similarly, in the modalities where the distal tip assembly comprises only the distal cover 400, although the distal cover 400 can be fixedly attached in relation to the core member 160, the distal cover 400 can also be rotatable and / or axially coupled in relation to the core member 160. Furthermore, when the distal tip assembly comprises both the distal tip structure and the distal cover, the distal tip assembly can be movably coupled rotationally and / or axially in relation to the core member; however, the distal tip assembly can also be fixedly coupled to the core member. Thus, as observed in a similar way above, some modalities of distal coverage
96/115 allow the core member to rotate freely in relation to the distal cover and the stent so that, therefore, prevent torsional forces from being exerted on the stent and / or distal cover as the core assembly is moved through the catheter to the treatment site.
[00283] As noted, the modalities of distal coverage can provide several advantages. For example, the use of the distal cover may allow the stent retention assembly to be easily propelled towards the treatment site inside the catheter. This can advantageously reduce the delivery force required to move the core assembly through the catheter. In addition, the distal tip assembly can be configured compactly, and therefore provide excellent maneuverability as the stent retention assembly moves through tortuous anatomy. In addition, a flexible distal cover, such as the distal covers shown 400, 400 ', 400, can also allow the distal portion of the stent to open or expand radially immediately as the distal portion of the stent exits the catheter. The distal cover can be easily propelled in the opposite direction to the first position or position of encapsulation or configuration in such a way that the expansion of the stent is not blocked and the expansion can be predictable to the clinician. Where used, this can be a significant improvement compared to prior art devices that used a relatively rigid tube, such as a spiral to distally distal a distal end of the stent, which could prevent or make the proper expansion or arrangement of a stent unpredictable. occlusion device, specifically, large diameter occlusion devices.
[00284] Furthermore, where the first portion 420 is flexible, liable to eversion and / or provides a minimum cross section, the assembly
97/115 of the distal tip can be easily recaptured inside the catheter to facilitate retraining to retract the core assembly into the catheter. In this way, the catheter can remain in place and the entire core assembly can be removed from it. This can enable the clinician to telescope one or more other occlusion devices (for example, so that it delivers more than one occlusion device such as overlapping another occlusion device) without having to remove the catheter, so that saves time and reduces trauma for the patient.
[00285] Figures 1 and 7 to 12 represent some modalities and methods of using the stent delivery system 100. First, catheter 110 can be inserted into the patient's vasculature through a paracutaneous access procedure assembly or another method of adequate access. The distal end 114 of catheter 110 is then advanced to a treatment site or location in blood vessel 102. Blood vessel 102 may comprise a vein or artery, such as an artery in a brain or inside a patient's skull . As previously mentioned, catheter 110 can comprise a microcatheter. A guide catheter can be used instead of or in addition to catheter 110; for example, the guide catheter can first be placed in the vasculature in such a way that it extends part or all of the trajectory to the treatment site and a microcatheter or other catheter is then inserted through the guide catheter into the treatment site.
[00286] The treatment site may be close to an aneurysm (not shown) formed in a blood vessel wall 102 and advancing catheter 110 to the treatment site may include advancing distal end 114 and / or distal opening 120 to a locality that is distal to the aneurysm. Such advancement of catheter 110 may include advancing distal end 114 and / or distal opening 120 dis
98/115 via the aneurysm ostium or neck, to the location in vessel 102 distal to the aneurysm.
[00287] Once catheter 110 has been inserted, it can extend proximally from distal end 114 and / or distal opening 120 at the treatment site, through the vascular access site, to proximal end 112 and / or connector 122 which are preferably located outside the patient's body.
[00288] After catheter 110 is placed, core assembly 140 (with stent 200 carried over it) can be inserted, the distal end first, into lumen 116 of catheter 110 through connector 122 and / or proximal end 112. When the distal portion of core assembly 140 is initially contained within an introducer sheath (not shown), the introducer sheath can be partially inserted into the catheter lumen 116 and core assembly 140 is advanced distally through the introducer sheath until the distal portion and stent 200 exit the distal end of the introducer sheath and pass lumen 116 of catheter 110 inward (direct contact with). Core assembly 140 and stent 200 are, at this moment, arranged in catheter 110, in general, as shown in Figure 1, however, in a proximal portion of catheter 110. In particular, stent 200 and the distal portion of core assembly 140 can be positioned in lumen 11 6 of catheter 110, so that the proximal end 202 of stent 200 is received in the constricting member 320 and the remaining portions of stent 200 extend distally and, in general, in contact with the internal surface 118 of the catheter, except where the first section 420 of distal cover 400 extends or interposes radially between distal end 204 of stent 200 and inner surface 118 of catheter 110. In addition, core member 160 and constricting member 320 can extend proximally to proximal end 112 and / or connector 122 to the catheter
99/115
110, to a location outside the patient's body, such that the coupling 360 and proximal ends 162, 322 of the core member 160 and constricting member 320 can be easily accessed.
[00289] Next, the core assembly 140 with the stent 200 can be axially advanced distally inside the lumen 116 of catheter 110, towards the distal end 114 of catheter 110 and the treatment location. In general, during advancement of core assembly 140 in catheter 110, constricting member 320 and projecting member 340 can secure, grasp, or engage stent 200 to facilitate stent distal thrust through catheter 110, substantially without transmitting any clamping forces for catheter 110 or otherwise independently of catheter 110. Constricting member 320 and projecting member 340 can clamp, grip, or engage stent 200 during distal advancement through catheter 110 without relative axial movement between the constricting member 320 and the projecting member 340, while the constricting member 320, the projecting member 340 and the stent 200 move distally in relation to catheter 110 and the vasculature.
[00290] As stent 200 and distal cover 400 are advanced towards distal end 114 and the treatment location, the first section 420 of distal cover 400 remains extended or radially interposed between outer surface 208 and / or distal end 204 of the stent 200 and the internal surface 118 of the catheter 110. In this way, the distal cover 400 can inhibit the distal end 204 of the stent 200 which advances (for example, the filament ends 212 of it) from damaging, rubbing, or gouging the catheter 110 and thus, therefore, prevents the stent 200 from falling along catheter 110. This, in turn, can prevent damage to stent 200 such as longitudinal compression resulting from the high friction generated between the end
100/115 of distal 204 of stent 200 and catheter 110 while distally directed force is exerted on the proximal portions of stent 200.
[00291] Where the treatment site is close to an aneurysm and the distal end 114 and / or distal opening 120 of catheter 110 have been advanced to a location that is distal to the aneurysm, advancing the core assembly 140 with stent 200 in towards distal end 114 and treatment location may include advancing distal portion of core assembly 140 and distal end 204 of stent 200 distally through catheter 110 across the aneurysm ostium or neck, to a location in vessel 102 distal of the aneurysm .
[00292] To start expanding the stent 200 (see Figure 7, that is, Figures 7A to 7C), core assembly 140 can be retained stationary and catheter 110 can be removed proximally over stent 200 and the portion distal from core assembly 140, until distal end 114 of catheter 110 is level or proximal to distal end 324 of constricting member 320 or level or proximal to proximal end 202 of stent 200 or proximal retention member 220, as shown in Figure 8. (Optionally, the core and stent assembly can be advanced distally while performing this step, rather than or in addition to withdrawing the catheter.) As a result, stent 200 (except for the portion retained in the constricting member 320) can be released and it can be allowed to expand to engage with the inner wall of blood vessel 102, as shown in Figure 8. Some modalities of stent 200 (such as certain traceable stents can decrease axially while expanding radially. As a result of (i) any axial ramp shortening of the stent 200, (ii) radial expansion of the stent 200 and / or (iii) radial expansion of the distal cover 400 in response to the radial expansion of the stent 200, the strip portions
101/115 or tube of the first section 420 of the distal cover 400 may disengage from contact with the distal end 204 of the stent 200, although in some embodiments, it separates and moves radially outward as well.
[00293] In some modalities, as the distal cover 400 disengages from the stent, it unwinds or, otherwise, detaches from its folded configuration 480 (see Figures 7 to 8). Once the distal cover 400 disengages or detaches, it no longer covers the distal end 204 of stent 200; instead, its first section 420 is thereafter spaced distally from that of the distal stent end 204 as shown in Figures 7 to 8. In that state, the strip or tube portions that form the proximal end can be free or not confined within the lumen of blood vessel 102. As noted above in a similar manner, the strip or tube portions may have first free ends, as well as second ends that are coupled to core assembly 140. The first free ends can cover at least a portion of the distal stent portion during stent delivery. In addition, when the stent is expanded and / or the core assembly 140 is removed proximally into the catheter, the strip or tube portions may be everted, such as the first free ends of the strips, wings, or elongated portions are attracted distal joints at the second ends of the same.
[00294] Withdrawal of catheter 110 (and / or distal movement of core assembly 140) and expansion of stent 200 can be performed in multiple discrete steps. For example, catheter 110 can initially be retracted proximally by only part of the path to the location shown in Figures 7A to C and only the distal portion 204 of stent 200 expanded for engagement with the wall of
102/115 vase. Such initial partial expansion facilitates the anchoring of the distal portion of the stent in vessel 102, which in turn facilitates longitudinal stretching or compression of stent 200 as desired by the clinician during or before the expansion of the remaining portions of stent 200 inward. of the vessel 102. The initial partial expansion may also facilitate confirmation by the clinician that the distal portion of the stent 200 has been deposited in the desirable location in vessel 102 (for example, distal to the neck or ostium of any aneurysm formed in the vessel wall ) prior to the expansion of the remaining portions of stent 200. In general, where an aneurysm is present in vessel 102, proper placement of stent 200 may include the placement of a distal portion! of the stent 200 in the distal lumen of the aneurysmal neck vessel and a proximal portion of the stent in the proximal lumen of the aneurysmal neck vessel, such that the stent 200 extends transversely to the neck. Where the expanded stent 200 is properly configured, a therapeutic flow deviation function is then performed in relation to the aneurysm.
[00295] While the stent delivery system 100 is in the configuration shown in Figure 8, with the proximal end 202 of the stent 200 retained within the constricting member 320, the partially expanded stent 200 can be retracted or retracted proximally into the catheter 110 as shown in Figures 9-
10. The engagement mechanism, for example, the constricting member 320 and the projecting member 340, can secure, grasp, or engage the stent 200 to a degree sufficient to allow the catheter 110 to be distally advanced over the partially expanded stent 200 ( and / or core member 160 removed proximally to catheter 110) until stent 200 is again positioned in lumen 116 of catheter 110. In this way, the engagement mechanism of core assembly 140 can exert a proximal force on the 200 con stent
103/115 as stent 200 is removed or retracted into catheter 110. [00296] Figure 9 shows a first aspect of a stent 200 retargeting process, in which stent 200, which includes distal end 204, was drawn into lumen 116 of catheter 110. Due to the fact that the anterior stent engagement portion (e.g., the first section 420) of the distal cover 400 has moved radially out of the core member 160 and / or distally with respect to the core member 160, this does not prevent the entry of the distal portion and distal end 204 of stent 200 into the distal opening 120 of catheter 110 during retargeting. Consequently, the re-routing process of Figures 9 to 10 may comprise moving stent 200 (which includes distal end 204) into catheter 110 through distal opening 120 while the anterior stent engagement portion (e.g., the first section 420) of distal cover 400 is in a second, everted configuration, or repackaging configuration in which the stent engagement portion is arranged radially outwardly from core member 160 and / or the first section 420 of distal cover 400 is arranged distally from the core member 160, the second section 440 and / or the distal tip structure 182, compared to the first encapsulation configuration, or delivery configuration (e.g., Figure 1) of the stent engagement portion ( for example, the first section 420) of the distal roof 400.
[00297] Although Figure 9 illustrates an initial aspect of the redraw process, Figure 10 shows a second aspect of the redraw process that is currently under discussion. In this aspect of the process, the core assembly 140 can be further moved proximally into the catheter 110 (and / or the catheter 110 is additionally moved distally over the core assembly 140) until the distal cover 400 enters the catheter 110 a
104/115 through the distal opening 120. As noted above, the first section 420 of the distal cover 400 is preferably flexible enough to everter, and therefore achieves the second everted configuration, or re-configuration shown in Figures 9 to 10 In the second everted configuration, or repackaging configuration, the first section 420 of the distal coverage 400 may generally extend in a distal direction, away from the 200 stent and / or extend distally to the second section 440 of the distal coverage 400. In addition, in some embodiments, the first section 420 of the distal cover 400 may also radially overlap the distal tip structure 182. Instead, or in addition to these aspects of the second everted configuration, or repackaging configuration, the distal coverage 400 may be radially small enough to extend into lumen 116 of catheter 110, either partially as r shown in Figure 9, as completely as shown in Figure 10 and / or the entire distal cover 400 can be spaced distally from distal end 204 of stent 200 in lumen 116 of catheter 110.
[00298] Consequently, according to some modalities of methods disclosed in this document, during the operation of the stent delivery system, a clinician can verify whether the initial partial expansion of the stent 200 (for example, as shown in Figures 7A to 8) and if the placement is unsatisfactory or if the initial expansion of the stent 200 is unsatisfactory, the clinician can recapture, collapse, withdraw, or retrain the stent 200 in catheter 110, as described above in relation to Figures 9 and / or 10. After re-routing, the clinician may make an attempt to deposit the stent again, as described in this document starting, for example, with the state shown in Figure 9 or 10 and so that it results, for example, in the state shown in Figure 7A. Re-routing can also
105/115 be performed and the stent delivery system 100 and stent 200 removed from the patient completely if, for example, the delivery and / or expansion of the stent 200 damages or reveals a defect, or inappropriate size of the stent 200 or delivery system. delivery 100. After an initial partial expansion of stent 200, the depicted core assembly 140 can optionally be removed entirely with stent 200 from catheter 110 without the need to remove catheter 110 from blood vessel 102. In this way, access the treatment site in blood vessel 102 can be maintained through catheter 110 and, if desired, additional attempts to deliver stent 200 can be performed through catheter 110.
[00299] If the initial expansion of stent 200 in vessel 102 is satisfactory, the total expansion can be completed to result in the state shown in Figure 11.0 360 coupling is removed, broken, or otherwise disengaged to allow the constricting member 320 moves relative to the core member 160. The proximal end 202 of the stent 200 can then be released from the constricting member 320 and the projecting member 340 by retaining the stationary core member 160 and removing the constricting member 320 proximally to core member 160 and stent 200 until distal end 324 is approximately flush with proximal retention member 220, or otherwise proximal to proximal end 202 of stent 200. (If distal end 114 of catheter 110 has not yet been removed to a proximal location of the proximal end 202 of stent 200, which can also be performed.) No longer constricted by constricting member 320 and the projecting member 340, the proximal end 202 of stent 200 can now expand so that it comes in contact with the vessel wall 102, as shown in Figure 11. (It is observed that up to this moment, according to an aspect of some modalities , the partially expanded stent 200
106/115 had been completely redeemable.) Where the vessel
102 includes an aneurysm, the proximal end 202 is preferably located in vessel 102 proximal to the aneurysm neck after expansion.
[00300] After the total expansion of the stent 200, the core assembly 140 can be retracted into the catheter 110, as shown in Figure 12. Both catheter 110 and core assembly 140 can be removed from the patient, both simultaneously in sequence. However, when the stent has been successfully released, core assembly 140 can also be removed entirely from catheter 110, with catheter 110 remaining in place and a second core assembly can be inserted into the lumen. The second core assembly can be configured to deliver a second stent to the treatment site to perform, for example, a telescopic procedure.
[00301] In another method embodiment, stent 200 can be partially expanded initially (for example, as shown in Figure 8) in a blood vessel 102 characterized by the fact that a branched vessel (not shown) joins the vessel blood at a junction located along the portion of vessel 102 in which stent 200 has been partially expanded. The unblocking of the branched vessel can then be verified, for example, by injecting a contrast agent close to the junction and observing through, for example, fluoroscopy whether the agent can flow from vessel 102 into the branched vessel . In this way it can be determined whether a portion of the stent 102 has occluded the branched vessel. If it becomes evident that the branched vessel has been occluded, stent 200 can be repositioned inside vessel 102 without re-routing, or stent 200 can be re-routed using any of the procedure assemblies discussed in this document. After redeployment, the stent 200 may
107/115 be partially expanded again and the unblocking of the branched vessel verified again.
[00302] In the present disclosure, several references are made with respect to moving catheter 110 axially over core assembly 140 and moving core assembly 140 axially within catheter 110. Except where specifically noted to the contrary, all such references to one form of this relative movement must be understood by including the others as an alternative.
[00303] As discussed above, the stent delivery system 100 can also be configured to allow the clinician to control the articulation and delivery of the system by targeting a portion of the system. For example, with reference to Figures 13A to B, the stent delivery system 100 can optionally include a 900 tipping tip assembly. The 900 tipping tip assembly can allow a clinician to prevent perforation or abrasion of the vase from a vase fork or a sharp curve in the vase while performing the procedure. As noted above, in some embodiments, the steerable tip assembly 900 may include core member 160, which may have a curvilinear distal end 164. Optionally, in some embodiments, the steerable tip assembly 900 may be employed with one or more projecting members 340 that are pivotally mounted on core member 160. Consequently, core member 160 can be configured to be steerable during stent expansion, or when the stent is inside the catheter or partially expanded in the interior of the vessel that can be rotated in relation to stent 200, catheter 110 and / or other components of the stent delivery system 100.
[00304] During use, the clinician can advance the stent delivery system 100 to the treatment location axially within the
108/115 vessel 102. In preparation for delivery and expansion of the 200 stent, the clinician may consult the vasculature surrounding the treatment site and determine whether there is a risk that the distal end of the core member will cause abrasion or perforate a wall of vessel according to the core member is advanced distally as anticipated during stent expansion or during the advancement of system 100 to the treatment location. In general, core member 160 and distal tip assembly 180 are often advanced distally in the course of expansion of a stent, such that early distal movement may be the result of stent delivery near a bifurcation or curve accentuated in the vase. If there is a risk that abrasion or perforation of a vessel will occur, the clinician may carefully deposit the stent and then (or before) rotate the core member to reorient or redirect the distal end or point of the core member toward the trajectory of the vessel and in the opposite direction to the vessel wall.
[00305] The risk of abrasion or perforation can be substantially greater when the treatment location is adjacent to a bifurcation or sharp curve in the vessel. For example, Figures 13A to B illustrate a scenario in which an apex 940 of a fork 942 rests on the anticipated path of the distal end 164 of the core member 160. In such a way, if the distal end 164 is advanced distally towards the apex 940 in the position, configuration, or orientation shown in Figure 13A (and specifically, if the core member and the distal tip are straight and not curved), there is a possibility that the apex of the bifurcation will be rubbed or punctured by the distal tip of the member of nucleus.
[00306] However, as shown in Figure 13B, to avoid abrasion or perforation, the distal end 164 of the core member 160 can be rotated to reorient the curved portion of the end
109/115 distal 164 towards a low-risk trajectory such as a desirable branched vessel. The distal end 164 can be formed from a radio-opaque material to make the distal end 164 visible under electromagnetic radiation or other imaging and therefore facilitate the clinician's recognition of the orientation of the distal end 164 with respect to the surrounding vasculature. After observing the orientation of the distal end 164, the clinician can determine how to aim the distal end 164 of the core member 160 to prevent abrasion or perforation of the vessel wall. For example, according to some modalities, after determining the proper direction after viewing the position of the distal end 164, the clinician can rotate and reorient the distal end 164 to point the core member 160 in a desirable or low-risk direction. rotating a proximal end of the core member 160. In addition, as noted in this document, turning the core member in relation to the stent may allow the clinician to avoid dislodging the stent from the vessel wall after the initial expansion of the stent and also avoid abrasion or perforation of the blood vessel. In this way, the stent delivery system can advantageously allow a clinician to direct and control the stent delivery system joint to ensure that the vessels adjacent to the treatment site are not damaged as the stent is deposited and the stent is assembled. core 140 is advanced.
[00307] Information regarding the additional modalities of the stent delivery system 100 and additional details and components that can optionally be used or implanted in the modalities of the stent delivery system described in this document, can be found in the Ordering Publications Patent no .: US 2011/0152998 A1 and US 2009 / 0318947A1 incorporated above. The stent delivery system 100 disclosed in this document can, optionally,
110/115 Finally, be similar to any of the delivery systems disclosed in these publications, except as further described in this document.
[00308] The apparatus and methods discussed in this document are not limited to the expansion and use of a stent or occlusion device inside any specific vessels, however, they can include any number of different types of vessels. For example, in some ways, the vessels may include arteries or veins. The vessels may have bifurcations and / or sharp curves. In some respects, the vessels may be suprathoracic vessels (for example, vessels in the neck or above), intrathoracic vessels (for example, vessels in the chest), sub-thoracic vessels (for example, vessels in the abdominal area or below), lateral thoracic vessels (for example, vessels on the sides of the chest such as vessels in the shoulder area and beyond), or other types of vessels and / or branches thereof.
[00309] In some aspects, suprathoracic vessels may comprise at least one of the intracranial vessels, cerebral arteries and / or any branches thereof. For example, suprathoracic vessels may comprise at least one of a common carotid artery, an internal carotid artery, an external carotid artery, a middle minineal artery, superficial temporal arteries, an occipital artery, a lacrimal (ophthalmic) artery, a minineal artery accessory, an anterior ethmoidal artery, a posterior ethmoidal artery, a maxillary artery, a posterior auricular artery, a descending pharyngeal artery, a vertebral artery, a left middle mininous artery, a posterior cerebral artery, an upper cerebellar artery, a basilar artery, a left internal acoustic (labyrinthine) artery, an anterior inferior cerebellar artery, a left descending pharyngeal artery, a posterior inferior cerebellar artery, a deep cervical artery, a supreme intercostal artery, a
111/115 costocervical trunk, subclavian artery, middle cerebral artery, anterior cerebral artery, anterior communicating artery, ophthalmic artery, posterior communicating artery, facial artery, lingual artery, superior laryngeal artery, thyroid artery superior, an ascending cervical artery, an inferior thyroid artery, a thyro-cervical trunk, an internal thoracic artery and / or any branches thereof. Suprathoracic vessels may also comprise at least one of a medial orbitofrontal artery, a recurrent (Heubner's) artery, medial and lateral lenticulo-striated arteries, a lateral orbitofrontal artery, an ascending frontal artery (candelabrum), an anterior choroidal artery, pontines, an internal acoustic (labyrinthine) artery, an anterior spinal artery, a posterior spinal artery, a posterior medial choroidal artery, a posterior lateral choroidal artery and / or branches thereof. Suprathoracic vessels may also comprise at least one of perforating arteries, a hypothalamic artery, lenticular-striated arteries, an upper pituitary artery, an inferior pituitary artery, an anterior thalamic-striated artery, a posterior thalamic-striated artery and / or their ramifications. Suprathoracic vessels can also comprise at least one of the pre-central (pre-Rolandica) and central (Rolandica) arteries, anterior and posterior parietal arteries, an angular artery, temporal arteries (anterior, middle and posterior), a paracentral artery , a pericalous artery, a callous marginal artery, a frontopolar artery, a pre-coneal artery, a parieto-occipital artery, a calcarine artery, an inferior vermian artery and / or branches thereof.
[00310] In some respects, suprathoracic vessels may also comprise at least one of diploic veins, an emissary vein, a cerebral vein, a medium mininous vein, superficial temporal veins, a frontal diploic vein, a diploic temporal vein
112/115 anterior, a parietal emissary vein, a posterior temporal diploic vein, an occipital emissary vein, a occipital diploic vein, a mastoid emissary vein, an upper cerebral vein, efferent pituitary veins, long pituitary portal veins and infundibulum (pituitary stem) and / or branches thereof.
[00311] Intrathoracic vessels may comprise the aorta or its branches. For example, intrathoracic vessels may comprise at least one of an ascending aorta, a descending aorta, an aortic arch and / or branches thereof. The descending aorta can comprise at least one of a thoracic aorta, an abdominal aorta and / or any branches thereof. Intrathoracic vessels may also comprise at least one subclavian artery, an internal thoracic artery, a pericardiacophrenic artery, a right pulmonary artery, a right coronary artery, a brachiocephalic trunk, a pulmonary trunk, a left pulmonary artery, an interventricular artery previous and / or branches thereof. Intrathoracic vessels may also comprise at least one of a lower thyroid artery, a thyro-cervical trunk, a vertebral artery, a right bronchial artery, an upper left bronchial artery, a lower left bronchial artery, aortic esophageal arteries and / or branches of the aortic themselves.
[00312] In some respects, intrathoracic vessels may also comprise at least one of a right internal jugular vein, a right brachycephalic vein, a subclavian vein, an internal thoracic vein, a pericardiacophrenic vein, an upper vena cava, an upper vena cava right superior pulmonary, a left brachiocephalic vein, left internal jugular vein, left superior pulmonary vein, inferior thyroid vein, an external jugular vein, a vertebral vein, right highest intercostal vein, the vein 6 intercostal
113/115 right, an azigo vein, an inferior vena cava, a supreme left intercostal vein, an accessory hemiazygos vein, a herniazygos vein, and / or branches thereof.
[00313] In some respects, the sub-thoracic vessels may comprise at least one of the renal arteries, inferior phrenic arteries, a celiac trunk with common hepatic arteries, left gastric and splenic arteries, superior adrenal arteries, a middle adrenal artery, an inferior adrenal artery, a right renal artery, a subcostal artery, 1 ^to 4 ^a right lymph arteries, common iliac arteries, an iliolumbar artery, an internal iliac artery, lateral sacral arteries, an external iliac artery, a testicular (ovarian) artery, an ascending branch the deep circumflex iliac artery, a superficial circumflex iliac artery, a lower epigastric artery, a superficial epigastric artery, a femoral artery, a testicular and deferent canal artery, a superficial external pudendal artery, a deep external pudendal artery and / or branches of the same. Sub-thoracic vessels may also comprise at least one of an upper masentery artery, a left renal artery, an abdominal aorta, an inferior masenteric artery, colic arteries, sigmoid arteries, an upper rectal artery, 5 ^the lumbar arteries, a sacral artery middle, an upper gluteal artery, umbilical and upper vesical arteries, a obturator artery, a lower vesical artery and an artery for the vas deferens, a middle rectal artery, an internal pudendal artery, an inferior gluteal artery, cremisteral, pubic (obturator anastomotic) branches of inferior epigastric artery, a left colic artery, rectal arteries and / or branches thereof.
[00314] In some respects, the lateral thoracic vessels may comprise at least one among humeral arteries, a transverse cervical artery, a suprascapular artery, a scapular artery
114/115 dorsal and / or branches thereof. The lateral thoracic vessels may also comprise at least one of an anterior circumflex humeral artery, a posterior circumflex humeral artery, a subescupular artery, a circumflex scapular artery, a brachial artery, a thoracodrosal artery, a lateral thoracic artery, an inferior thyroid artery, a tirocervical trunk, a subclavian artery, an upper thoracic artery, a thoracoacromial artery and / or branches thereof.
[00315] In some embodiments, delivery system 100 may include an expandable occlusion device (e.g., stent 200) configured to be placed transversely to an aneurysm. The occlusion device can be delivered through the distal portion of the catheter, out of a distal tip assembly and into a vasculature adjacent to an aneurysm, for example, in the middle cerebral artery. A proximal portion of the catheter may remain partially or totally inside a guide catheter during delivery and an intermediate portion, tapered portion and distal portion of the catheter may extend distally to the guide catheter. The occlusion device can be released at the target location and can be used to occlude blood flow into the aneurysm. The catheter can be used to reach target locations (eg, aneurysms) located elsewhere in the body as well as, including, but not limited to, other arteries, branches and blood vessels such as those described above.
[00316] The apparatus and methods discussed in this document are not limited to the delivery and use of an occlusion or stent device within the vascular system, however, they can include any number of treatment applications. Other treatment sites may include areas or regions of the body such as organ bodies.
[00317] Although the detailed description contains several specifi
115/115 cations, they should not be interpreted as limiting the scope of the technology in question, but merely as illustrative of examples and illustrative aspects of the technology in question. It should be noted that the scope of the technology in question includes other modalities not discussed in detail above. Various other modifications, changes and variations can be made in the arrangement, operation and details of the method and apparatus of the technology in question disclosed in this document without departing from the scope of the present disclosure. Unless otherwise stated, a reference to an element in the singular is not intended to mean one and only one except when specifically mentioned, but it means one or more. In addition, it is not necessary for a device or method to mention all problems that are solved by means of different disclosure modalities in order to be covered by the scope of the disclosure.

权利要求:
Claims (16)
[1]
1. Core assembly characterized by the fact that it comprises:
a core member that has an intermediate region and a distal tip;
a stent extending over the intermediate member region of the nucleus and comprising a distal portion; and a distal cover comprising a first end and a second end, the second end being coupled to the distal tip, the distal cover having a delivery orientation in which the first end (i) extends proximally to the tip distal and (ii) at least partially surrounds the distal stent portion, the distal cover being movable from the delivery orientation to an everted orientation in which the first end is positioned distally from the second end:
wherein the distal cover is configured to rotate around the core member.
[2]
Core assembly according to claim 1, characterized in that the first end of the distal cover comprises a folded portion.
[3]
3. Core assembly, according to claim 2, characterized by the fact that the folded portion comprises an inner layer and an outer layer, the inner layer being positioned in an intermediate way to the stent and the outer layer, the inner layer is eversible to facilitate stent expansion.
[4]
Core assembly according to claim 1, characterized in that the distal cover comprises one or more elongated strips of material.
2/3
[5]
Core assembly according to claim 1, characterized by the fact that the distal cover comprises no more than two elongated strips of material.
[6]
6. Core assembly according to claim 1, characterized by the fact that the distal coverage extends over at least about one third of the stent.
[7]
7. Core assembly according to claim 1, characterized by the fact that the distal tip of the core member comprises a tip structure carried by the core member, the distal cover being coupled to the tip structure.
[8]
Core assembly according to claim 7, characterized in that the tip structure comprises at least one cross member oriented, in general, transversely to the core member and the distal cover is coupled to the tip structure in by virtue of the formation of a shell that involves at least one cross member.
[9]
Core assembly according to claim 8, characterized in that the tip structure comprises a spiral and the at least one cross member comprises at least one segment of the spiral.
[10]
Core assembly according to claim 9 characterized by the fact that the distal cover forms a wrapper that involves at least one spiral segment by virtue of being wound, at least partially, around the segment.
[11]
11. Core assembly according to claim 1, characterized by the fact that the distal tip comprises Teflon.
[12]
Core assembly according to claim 1, characterized in that the core member comprises a wire.
[13]
13. Core assembly, according to any of the
3/3 claims 1 to 12, characterized by the fact that the second end of the distal covering is coupled in a rotating manner in relation to the core member.
[14]
Core assembly according to claim 13, characterized in that the stent is configured to rotate around the core member, at least in part, due to the rotatable coupling of the distal cover.
[15]
15. Core assembly according to claim 7, characterized by the fact that the tip structure is rotatable in relation to the core member.
[16]
Core assembly according to any one of claims 1 to 15, characterized in that the core member comprises a hypotube.

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-02-04| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-08-10| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-10-13| B350| Update of information on the portal [chapter 15.35 patent gazette]|

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2021-11-23| B11D| Dismissal acc. art. 38, par 2 of ipl - failure to pay fee after grant in time|

优先权:

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申请号 | 申请日 | 专利标题

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US201261602567P| true| 2012-02-23|2012-02-23|

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US61/602,567|2012-02-23|

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US201261679106P| true| 2012-08-03|2012-08-03|

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US61/679,106|2012-08-03|

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US13/614,349|2012-09-13|

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US13/614,349|US20130226278A1|2012-02-23|2012-09-13|Methods and apparatus for luminal stenting|

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US13/664,547|US20130304185A1|2012-02-23|2012-10-31|Methods and apparatus for luminal stenting|

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US13/664,547|2012-10-31|

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US13/692,021|US8591566B2|2012-02-23|2012-12-03|Methods and apparatus for luminal stenting|

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US13/692,021|2012-12-03|

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PCT/US2013/026562|WO2013126299A1|2012-02-23|2013-02-18|Methods and apparatus for luminal stenting|

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