巴西专利BR112014022291B1 CATHETER SET

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专利摘要:
the catheter set. This report describes the treatment of a patient's vasculature with an expandable implant. the implant is constrained to a reduced diameter delivery from within the vasculature by at least one sleeve. the implant can be constrained to other diameters, such as intermediate diameters. the gloves can be expanded, allowing expansion of the expandable implant diameter by disengaging a coupling member from the glove or gloves from outside the patient's body. the expandable implant may include a guideline or lines that facilitate flexion and direction of the expandable implant through a patient's vasculature.
公开号:BR112014022291B1
申请号:R112014022291-6
申请日:2013-01-21
公开日:2021-08-24
发明作者:Patrick M. Norris
申请人:W. L. Gore & Associates, Inc；
IPC主号:

专利说明:

[0001] This application claims priority from provisional patent application US 61/610,372 entitled "External steerable fiber for use in endoluminal implantation of expandable devices" and filed March 13, 2012, which is incorporated herein by reference in its entirety . FUNDAMENTALS OF THE INVENTION
[0002] The present invention relates generally to endoluminal devices and, more specifically, to guideable endoluminal devices within the vasculature of a patient. PRIOR TECHNIQUE
[0003] Endoluminal therapies typically involve the insertion of a delivery catheter to transport a prosthetic device implanted into the vascular system through a small, often percutaneous, access site into a remote vessel. Once access to the vasculature is achieved, the delivery catheter is used to mediate endoluminal delivery and subsequent device implantation through one of several techniques. In this way, the device can be remotely implanted to obtain a therapeutic result. In contrast to conventional surgical therapies, endoluminal treatments are distinguished by their "minimally invasive" nature.
[0004] Expandable endoluminal devices can consist of a graft or a stent component, with or without a covering graft along the stent interstices. They can be designed to expand when a retention system is removed or be a balloon expanded from its delivery diameter, through a variety of intermediate diameters, up to a maximum, pre-determined functional diameter.
[0005] It remains desirable to provide improved systems for endoluminal delivery and implantation of expandable endoluminal devices into vascular treatment sites. BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The accompanying drawings are included to provide a better understanding of the description and are incorporated into and constitute a part of this specification, and illustrate embodiments of the invention and together with the description serve to explain the principles of the invention, wherein:
[0007] Figure 1 illustrates a side view of a catheter assembly that has an expandable implant;
[0008] Figures 2A and 2B illustrate perspective views of catheter assemblies with expandable implants;
[0009] Figures 3A-3B and 3C-3D illustrate cross-sectional and perspective views, respectively, of catheter assemblies with expandable implants;
[0010] Figures 4A-4D illustrate multiple profile views of a distal end of an expandable implant;
[0011] Figures 5A to 5D illustrate perspective views of a catheter assembly having an expandable implant;
[0012] Figure 6 illustrates a perspective view of an expandable implant;
[0013] Figures 7A-7H illustrate cross-sectional views of an expandable implant and sleeve;
[0014] Figure 8 illustrates a cross-sectional view of the catheter assembly having an expandable implant;
[0015] Figure 9 illustrates a side view of a catheter assembly having an expandable implant;
[0016] Figure 10A illustrates a side view of a catheter assembly having an expandable implant;
[0017] Figures 10B-10D illustrate interior curve, exterior curve and open views, respectively, of the expandable implant and direction lines illustrated in Figure 10A; and
[0018] Figures 11A-11B illustrate additional configurations of expandable implants with guide lines. DETAILED DESCRIPTION
[0019] Those skilled in the art will readily appreciate that the various aspects of the present invention can be accomplished by any number of methods and apparatus configured to perform intended functions. Differently stated, other methods and apparatus can be incorporated here to perform the intended functions. It should also be noted that the accompanying drawing Figures referred to herein are not all drawn to scale, but may be exaggerated to illustrate various aspects of the present invention, and so far as the Figures in the drawings are concerned, they should not be construed as limiting. Finally, although the present invention can be described in connection with several principles, the present invention should not be limited by theory.
Throughout this specification and claims, the term "distal" refers to a site that is, or a portion of, an endoluminal device (such as a stent graft) that, when implanted, is more downstream in blood flow than another portion of the device. Likewise, the term "distal" refers to the direction of blood flow or downstream in the direction of blood flow.
[0021] The term "proximal" refers to a site that is, or a portion of an endoluminal device that when implanted, is upstream with respect to the blood flow than another portion of the device. Likewise, the term "proximal" refers to the direction opposite the direction of blood flow or upstream from the direction of blood flow.
[0022] Also with respect to the proximal and distal terms, and because the present invention is not limited to peripheral and/or central approaches, this disclosure should not be interpreted restrictively with respect to these terms. Rather, the devices and methods described herein may be altered and/or adjusted in relation to a patient's anatomy.
[0023] Throughout this specification and claims, the term "front" refers to a relative location on the device that is closest to the end of the device, which is inserted into and progressed through a patient's vasculature. The term "rear" refers to a relative location on the device that is closest to the end of the device that is located outside of a patient's vascular system.
[0024] In various embodiments, a catheter assembly is described that utilizes one or more flexible gloves that (i) releasably constrain an expandable implant, such as an expandable endoluminal stent graft, toward a suitable dimension for the delivering the stent for local treatment, such as a vascular limb in a patient's body; and (ii) to further restrict the implant to an outer peripheral dimension larger than the dimension suitable for endoluminal delivery, but smaller than an unrestricted or fully implanted outer peripheral dimension, thereby facilitating selective and/or rotational or rotational axial positioning or further manipulation of the implant at the treatment site prior to complete implantation and expansion of the implant.
[0025] Several embodiments of the present invention comprise a catheter assembly configured to deliver an expandable implant to a treatment area of a patient's vasculature. In accordance with a number of embodiments, the catheter assembly includes at least one guideline that allows selective flexion of the expandable implant within the vasculature.
[0026] With initial reference to Fig. 1, a catheter assembly 100 in accordance with the present invention comprises an expandable implant 106, the expandable implant 106 may comprise any device suitable for endoluminal delivery to the treatment area of a vasculature. Such devices can include, for example, grafts, stents, and stent grafts. Thus, the expandable implant can include one or more stent components with one or more graft members disposed over and/or under the stent, which can expand from a delivery diameter through a variety of larger diameters. , intermediates, and for a predetermined maximum functional diameter.
[0027] In various embodiments, the expandable implant 106 comprises one or more stent members made of nitinol and a graft member made of ePTFE. However, as discussed above, any suitable combination of stent components and graft members is within the scope of the present invention.
[0028] For example, the stent members can have various configurations, such as, for example, flat shaped rings, tubes, coiled wires (or tapes or sheets) rolled into a tubular shape. Stent components can be formed from metal or natural polymeric materials and can include conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorothylene on PVC and polyurethane polymers organosilicon elastomers; metals such as stainless steels, cobalt-chromium alloys and nitinol and materials of biological origin such as bovine arteries/veins, pericardium and collagen. Stent components can also comprise resorbable materials such as poly(amino acids), poly(anhydrides), poly(caprolactones), poly(lactic/glycolic acid) polymers, poly(hydroxybutyrates) and poly(orthoesters). Any configuration of the expandable member that can be delivered by a catheter is in accordance with the present invention.
[0029] In addition to polytetrafluoroethylene, potential materials for graft limbs include, for example, expanded (ePTFE), polyester, polyurethane, fluorinated polymers such as perfoorelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra-high polyethylene molecular weight, aramid fibers, and combinations. Other embodiments of a limb graft material may include high strength polymer fibers such as ultra high molecular weight polyethylene fibers (eg Spectra, Dyneema Purity®, etc.) or aramid fibers (eg. , Technora, etc). The graft member can include a bioactive agent. In one embodiment, an ePTFE graft includes a carbon member along a blood contact surface thereof. Any graft member that can be delivered by a catheter, in accordance with the present invention.
[0030] In various embodiments, a stent component and/or a graft member can comprise a therapeutic coating. In these embodiments, the interior and/or exterior of the stent component and/or a graft member can be coated with, for example, a CD34 antigen. In addition, any number of drugs or therapeutic agents can be used to coat the graft limb, including, for example, heparin, sirolimus, paclitaxel, everolimus, ABT-578, mycophenolic acid, tacrolimus, estradiol, free radical scavenger. oxygen, biolimus A9, anti-CD34 antibodies, PDGF receptor blockers, MMP-1 receptor blockers, VEGF, G-CSF, HMG-CoA reductase inhibitors, iNOS and eNOS stimulators, ACE inhibitors, ARB, doxycycline, and thalidomide, among others.
[0031] In various embodiments, the expandable implant 106 may comprise a radially closed configuration suitable for delivery to the treatment area of a patient's vasculature. The expandable implant 106 can be constrained to a radially closed configuration and releasably mounted over a delivery device, such as a catheter shaft 102. The diameter of the expandable implant 106 in the closed configuration is small enough for the implant to be delivered through from the vasculature to the treatment area. In various embodiments, the diameter of the folded configuration is small enough to minimize the crossover profile of the catheter assembly 100 and to reduce or prevent tissue damage to the patient. In the closed configuration, the expandable implant 106 can be guided by the shaft of the catheter 102 through the vasculature.
[0032] In various embodiments, the expandable implant 106 may comprise a radially expanded configuration suitable for implanting the device in the treatment area of a patient's vasculature. In the expanded configuration, the diameter of the expandable implant 106 can be approximately equal to that of the vessel to be repaired. In other embodiments, the diameter of the expandable implant 106 in the expanded configuration may be slightly larger than the vessel being treated to provide a traction fit within the vessel.
[0033] In various embodiments, the expandable implant 106 can include a self-expanding device, such as a self-expanding stent graft. Such devices expand radially from a closed configuration to a radially expanded configuration when unconstrained. In other embodiments, expandable implant 106 may include a device that is expanded with the aid of a secondary device, such as, for example, a balloon. In still other embodiments, catheter assembly 100 can comprise a plurality of expandable implants 106. The use of a catheter assembly with any number of expandable implants is within the scope of the present invention.
[0034] Various medical devices according to the invention comprise a glove or gloves. The glove or gloves can condition an expandable implant device in a closed configuration for delivery of the stent to a treatment portion of a patient's vasculature. For the purposes of the description, the term "condition" may mean (i) limiting the expansion, either by self-expanding or assisted by a device, of the diameter of an expandable implant or (ii) covering or enveloping but not otherwise containing an expandable implant (eg for storage or biocompatibility reasons and/or to provide protection for the expandable implant and/or the vasculature). Catheter assembly 100, for example, comprises a sleeve 104 that surrounds and confines expandable implant 106 to a reduced or closed diameter configuration.
[0035] After implantation, the glove or gloves can be removed in order to allow the expandable implant to expand to a functional diameter and achieve a desired therapeutic result. Alternatively, the glove or gloves can remain attached to the implant or otherwise implanted without interfering with the expandable implant.
[0036] In various embodiments, an expandable implant is constrained by a single sleeve circumferentially surrounding the expandable implant. For example, with reference to FIG. 2B, the catheter assembly 200 includes a sleeve 204. In various embodiments, the sleeve 204 circumferentially surrounds the expandable implant 206 and confines it to a closed configuration, in which the diameter is less than the diameter of an implant without restriction or otherwise used. For example, sleeve 204 may constrain expandable implant 206 toward a closed configuration for delivery into the vasculature.
[0037] In other embodiments, an expandable implant is constrained by a plurality of gloves circumferentially surrounding the expandable implant, which allow the expandable implant to be deployed and maintained in intermediate configurations larger than the closed configuration and smaller than the unfolded configuration. The plurality of gloves may comprise at least two gloves circumferentially encircling each other.
[0038] In various embodiments, gloves can be tubular and serve to constrain an expandable implant. In such configurations, gloves are formed from a sheet of one or more materials rolled or folded over the expandable implant. Although the illustrative embodiments herein are described as comprising one or more tubular gloves, gloves of any shape non-tubular which correspond to an underlying expandable implant or which are otherwise appropriately molded for a particular application, are also within the scope of present invention.
[0039] In various embodiments, gloves are formed by wrapping or folding the sheet of material(s) such that two parallel edges of the sheet are substantially aligned. Said alignment may or may not be parallel or coaxial with the catheter axis of a catheter assembly. In various embodiments, the edges of the sheet of material(s) do not contact each other.
[0040] In various embodiments, the edges of the sheet of material(s) do not contact each other and are coupled with a coupling member (as described below), an adhesive, or the like. In various other embodiments, the edges of the sheet of material(s) are aligned so that edges of the same side of the sheet or sheets (e.g., the front or back of the sheet) are in contact with each other. In still other embodiments, the edges of opposite sides of the sheet of material(s) are in contact with each other, such that the ends overlap each other, such that a portion of one side of the sheet is in contact with a portion on the other side. In other words, the front of the sheet may overlap the back of the sheet, or vice versa.
[0041] In various embodiments, gloves comprise materials similar to those used to form a graft member. For example, a flexible precursor sheet used to make the sleeve can be formed from a thin, flat-walled ePTFE tube. Thin wall tube may incorporate "rip-stops" in the form of high strength longitudinal fibers bonded or embedded in the sheet or tube wall.
[0042] The sheets of materials used to form the glove(s) may comprise a series of openings, such that the openings extend from one edge of the sheet to the other. In such configurations, the coupling member can be woven or sewn through the series of openings in the sheet of material(s), securing each of the two edges together and forming a tube. For example, in FIG. 1, coupling member 124 protects the edges of sleeve 104 such that sleeve 104 holds expandable implant 106 toward a reduced diameter or peripheral outer dimension suitable for endoluminal delivery.
[0043] In various embodiments, the coupling member may comprise a woven fiber. In other embodiments, the coupling member may comprise a monofilament fiber. Any type of rope, cord, thread, fiber, or yarn that is capable of holding a glove in a tubular shape is within the scope of the present invention.
[0044] In various embodiments, a single coupling member can be used to constrain the diameter of one or more sleeves. In other embodiments, multiple coupling members can be used to constrain the diameter of one or more sleeves.
[0045] Once a suitable expandable implant is in a closed configuration, the expandable implant can be implanted within a patient's vasculature. An expandable implant in a collapsed configuration can be introduced into a vasculature and directed by a catheter assembly to a treatment area of the vasculature. Once in position in the vasculature treatment area, the expandable implant can be expanded to an expanded configuration.
[0046] When the expandable implant is in position within the vasculature, the coupling member or members can be disengaged from the glove or the gloves from outside the patient's body, which allows the glove(s) open and the expandable implant expands. As discussed above, the expandable implant can be by self-expansion, or the implant can be expanded by an expansion device such as a balloon.
[0047] The coupling member or members can be disengaged from the glove or gloves by a mechanical mechanism operated from outside the patient's body. For example, the member or members can be disabled by applying sufficient tension to the member or members. In another example, a transposable member can be attached to the coupling member or the outer body members. Displacement of translatable members, such as rotating a dial or rotating member or translating a handle or knob, can provide sufficient tension to displace and disengage the coupling member or members.
[0048] In various embodiments, disengaging a single coupling member that closes a single sleeve from the sleeve allows the expandable device to be expanded to a larger diameter or an outer peripheral dimension. For example, with reference to FIG. 2A, catheter assembly 200 can be used to deliver an expandable implant 206 to a treatment area of a vasculature. The expandable implant 206 has a collapsed diameter for delivery, and the sleeve 204 circumferentially surrounds the expandable implant 206 and is held closed by the coupling member 224. As described in more detail below, the folding of the expandable implant 206 can be controlled prior to full expansion (eg to an intermediate diameter) to help facilitate distribution to the desired position. Once the expandable implant 206 is in position relative to the treatment area, the coupling member 224 is disengaged from the sleeve 204 and the sleeve 204 is released, allowing the expandable implant 206 to expand to a larger diameter.
[0049] As mentioned above, in various embodiments of the present description, an expandable implant may further comprise an intermediate configuration. In the intermediate configuration, the diameter of the expandable implant is restricted to a diameter smaller than the expanded configuration and larger than the closed configuration. For example, the diameter of the expandable device in the intermediate configuration can be about 50% of the diameter of the expandable device in the expanded configuration. However, any diameter of the intermediate configuration, which is smaller than the diameter of the expanded configuration, and larger than the closed configuration, is within the scope of the invention.
[0050] In such embodiments, the expandable implant can be expanded from the closed configuration to the intermediate configuration when the implant has been delivered close to the treatment area of a patient's vasculature. The intermediate configuration can, among other things, help in the correct orientation and location of the expandable implant within the treatment area of the vasculature.
[0051] In various embodiments, an expandable implant may be concentrically surrounded by two sleeves having different diameters. In these configurations, a main sleeve constrains the expandable implant to the closed configuration. Once the closed configuration sleeve is opened, a secondary sleeve constrains the expandable implant to the intermediate configuration. As discussed above, the expandable implant can be self-expanding, or the implant can be expanded by a device such as a balloon.
[0052] For example, with reference to FIG. 2A, a catheter assembly 200 comprises an expandable implant 206 and a sleeve 204. Secondary sleeve 204 constrains the expandable implant 206 to an intermediate configuration. Secondary sleeve 204 is held in position around expandable implant 206 by secondary coupling member 224.
[0053] The catheter assembly 200 further includes a primary sleeve 208, which restricts the expandable implant 206 to a closed configuration, for delivery into a patient's vasculature. Primary sleeve 208 is held in position around expandable implant 206 by primary coupling member 234.
[0054] Once the expandable implant 206 is sufficiently close to the vasculature treatment area, the primary coupling member 234 is disengaged from the primary sleeve 208, which releases the primary sleeve 208 and allows the implant 206 to expand to a diameter bigger.
[0055] With reference to FIG. 2B, after primary sleeve 208 is enlarged, secondary sleeve 204 constrains expandable implant 206 to the intermediate configuration. In the intermediate configuration, as mentioned above and as described in more detail below, the expandable implant 206 can be oriented and adjusted (e.g., by flexion and torsional rotation) to a desired location within the treatment zone of the vasculature.
[0056] In other embodiments of the present invention, a single or "mono" or sleeve may be used to restrain the expandable implant in both a closed configuration and an intermediate configuration. For example, with reference to Figs. 3A-3D, catheter assembly 300 comprises an expandable implant 306, a mono sleeve 304, a primary coupling member 334, and a secondary coupling member 324.
[0057] Mono sleeve 304 further comprises a plurality of secondary holes 332. In this configuration, a secondary coupling member 324 is stitched or woven through secondary holes 332, constricting mono sleeve and expandable implant 306 to the diameter of one configuration. intermediate. In the intermediate configuration, the diameter of the expandable implant 306 is smaller than the enlarged diameter and larger than the diameter of the closed configuration. In the intermediate configuration, as described in more detail below, the expandable implant 306 can be oriented and adjusted (e.g., by flexion and torsional rotation) to a desired location within the treatment zone of the vasculature.
The mono glove 304 further comprises a plurality of primary holes 330. In this configuration, a primary coupling member 334 is stitched or woven through the primary holes 330, constraining the mono glove 304 and the expandable implant 306 to the closed configuration. The diameter or outer peripheral dimension of the closed configuration is selected to allow delivery of the expandable stent 306 to the treatment area of a patient's vasculature.
[0059] Once the expandable implant 306 has been delivered to a region close to the vasculature treatment area, the primary coupling member 334 can be detached from the mono sleeve 304, allowing the expandable implant 306 to be expanded to the intermediate configuration. The expandable implant 306 can be oriented and adjusted (e.g., by flexion and rotational torsion) to a desired location within the treatment zone of the vasculature. After final positioning, secondary coupling member 324 can be detached from mono sleeve 304, and expandable implant 306 can be expanded to the expanded configuration.
[0060] Although a number of specific configurations of constraint members (eg primary and secondary members) and gloves (eg primary and secondary gloves) have been discussed, the use of any number and/or configuration of constraint members and any number of gloves are within the scope of the present invention. In addition, the expandable implant can be allowed to partially expand to the intermediate configurations and expanded by partially selectively disengaging the secondary and primary engagement members of the mono sleeve, respectively.
[0061] In various embodiments, the catheter further comprises a steering line assembly. In such configurations, tension can be applied to the guideline to shift the guideline and bend the expandable implant. Folding the expandable implant can, among other things, help travel through curved or tortuous regions of the vasculature. Folding the expandable implant can also allow the implant to conform to the curvatures in a patient's vasculature.
[0062] For example, with reference to Figs. 2A-2B, the guide line 220 passes from outside a patient's body, through the catheter shaft 202, and is releasably coupled to the implant 206 in such In configurations, guide line 220 can be threaded through expandable implant 206 so that tension applied to guide line 220 outside the patient's body causes expandable implant 206 to bend in a desired manner.
[0063] As a further example, with reference to FIG. 6, an expandable implant 606 is illustrated. The guide line 620 is threaded along the surface of the expandable implant 606.
[0064] In various embodiments, guideline 220 may comprise metallic, polymeric or natural materials, may also include conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochloroethylene in PVC and polyurethane, elastomeric silicon organic polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol. Elongated members or locking wires can also be formed from high strength polymer fibers such as ultra high molecular weight polyethylene fibers (eg Spectra, Dyneema Purity®, etc.) or aramid fibers (by example, Technora, etc).
[0065] With reference to Fig. 7A-H, cross-sectional views of various configurations of expandable implants are illustrated. In various embodiments, an expandable implant can comprise a stent 705 and a graft member 707, which is surrounded by sleeve 704. In such configurations, a guide line 720 can be threaded through stent 705, a graft member 707. , and/or the 704 sleeve in a variety of different patterns. Such patterns can, among other benefits, facilitate folding of the expandable implant by applying tension to (and corresponding displacement) 720 direction line outside the body. Additionally, these patterns can reduce or prevent the 720 guideline from damaging tissue within the patient's vasculature, limiting or preventing "bowstringing." Bowstringing occurs when a thread or thread travels in a straight line between two points on the inside of a curve in an expandable graft. This can cause the thread or thread to come in contact with and potentially damage tissue in the vasculature. Bowstringing and its effects on tissue can also be reduced and/or minimized by the 704 sleeve, as the 704 sleeve surrounds the 720 direction line during folding and prior to full expansion of the expandable implant.
[0066] As illustrated in FIGS. 7B-7H, steering line 720 can be woven through any combination of stent 705, graft member 707, and sleeve 704 In each Figure, described below, a segment of a pattern is depicted. A guideline can be woven between a stent, a graft limb, and the glove, in any combination of these patterns. Alternatively, the guideline may interact with an expandable implant and one or more gloves in no way that allows the guideline 720 to bend the expandable implant in a desired manner.
[0067] In Fig. 7B, the guide line 720 is threaded between the inner wall of the sleeve 704 and the stent 70. In FIG. 7C, guide line 720 passes between a first apex 751 of stent 705 and the outer wall of graft member 707, passes between second apex 742 and interior wall of glove 704, extends to and through the wall of the limb. of graft 707, re-enters graft member 707, passes between a third apex 753 of stent 705 and the interior wall of glove 704, and passes between a fourth apex 754 and interior wall of glove 704. In FIG. 7D, guide line 720 passes between first tip 751 and the outer wall of graft member 707, then between second tip 752 and inner wall of sleeve 704.
[0068] In Fig. 7E, direction line 720 passes between the first tip 751 and the outer wall of graft member 707, extends through the outer wall of graft member 707, re-enters graft member 707, and passes between the third apex 753 and the outer wall of the graft member 707. In FIG. 7F, guideline 720 passes between the outer wall of graft member 707 and stent 705.
[0069] In Fig. 7G, direction line 720 passes from the inner wall of graft member 707, through the outer wall of graft member 707 between the first 751 and second 752 vertices, back through the outer wall of the limb of graft 707, and back through the interior wall of graft member 707 between third apex 753 and fourth apex 754. In FIG. 7H, guide line 720 is disposed against the inner wall of graft member 707. As discussed previously, Figs. 7B-7G illustrate examples of patterns where a guideline can interact with an expandable implant. Any mode in which a direction line interacts with an expandable implant facilitates the folding of the implant within the scope of the present disclosure.
[0070] In various configurations, a catheter assembly may include more than one guideline. For example, with reference to FIG. 9, catheter assembly 900 comprises two guide lines 920. As described in relation to Figs. 7A-7G, guide lines 920 can be woven across the surface of expandable implant 906. In various embodiments, guide lines 920 can exit the axis of catheter 902 and engage expandable implant 906 near the proximal end of the expandable implant 906. In such configurations, guide lines 920 may move transversely and remain substantially in contact with the surface of expandable implant 906 from the proximal end to the distal end. Guide line 920 may then release the expandable implant surface 906 and secure catheter assembly 900.
[0071] In various embodiments, the direction lines 920 interact with the expandable implant surface 906 in a pattern that facilitates the folding of the controllable expandable implant 906. For example, as illustrated in FIG. 9, guide lines 920 can traverse the surface of expandable implant 906 so that, across a significant portion of expandable implant 906, both guide lines 920 are parallel and in close proximity to each other. Such a configuration allows the tension applied to 920 guide lines to work together to form a bend or curvature in the same expandable implant segment 906. Any configuration of guide lines 920 and expandable implant surface 906 allows for selective flexion and controllable expandable implant 906 is within the scope of the present invention.
[0072] In various embodiments, one or more guide lines are configured to allow selective and controllable flexion of an expandable implant, for example, as described above, and also to allow temporary, non-concentric coupling of an implant expandable, relative to a catheter assembly. For example, it may be desirable for a portion of the interior surface of an expandable implant to be temporarily coupled distally to a catheter assembly. Such a portion, for example, may be what will present the largest radius of curvature during selective and controllable flexion of the expandable implant, either during and/or after its delivery and implantation. Such a portion may thus be an outer curved portion of an expandable implant.
[0073] To achieve the above objectives, in various embodiments, one or more direction lines may start and end at proximal and distal ends, respectively, along an edge of an expandable implant that will have the largest radius of curvature during selective and controllable bending. Between the distal and proximal ends, one or more direction lines can transition to and along an edge of an expandable implant that will have the smallest radius of curvature during selective and controllable flexion.
[0074] For example, with reference to FIG. 10A, a catheter assembly 1000 is illustrated as having a catheter shaft 1002 temporarily coupled distally to an outer curved portion of the inner surface of an expandable implant 1006 by two direction lines 1020, each comprising a helical pattern. As described in relation to Figs. 7a through 7G, guide lines 1020 can be woven across the surface of expandable implant 1006. In various embodiments, guide lines 1020 can exit catheter shaft 1002 and surround expandable implant 1006 near the distal end. of the expandable implant 1006. In such configurations, the guide lines 1020 may migrate and remain substantially in contact with the surface of the expandable implant 1006 from the distal end to the proximal end. Guide line 1020 may then release the surface of expandable implant 1006 and become secured to catheter assembly 1000.
[0075] As illustrated in FIGS. 10B-10D, illustrating the inner curve, outer curve, and open views, respectively, of the expandable implant and the guide lines illustrated in Figure 10A, the helical pattern of each guide line 1020 begins near the distal end on the outer curve of the implant. expandable 1006 and terminates thereon proximally within the expandable implant curve 1006. Each direction line 1020 continues in a direction substantially parallel to the central axis of the expandable implant 1006 to the proximal end within the expandable implant curve 1006, where it circumferentially traverses the expandable implant 1006 and returns to its outer curve. As illustrated in FIGS. 10B-10D, the pattern of each guideline 1020 mirrors the other across a sagittal plane through the central axis of the expandable implant 1006. In this way, the guide lines 1020 cooperate to allow controllable selective flexion of the expandable implant 1006, as well as to allow non-concentric, temporary coupling of the expandable implant 1006 with respect to the axis of the catheter 1002. Any configuration of guide lines 1020 and expandable implant surface 1006 allowing for selective and controllable flexion and non-concentric, temporary coupling of the expandable implant 1006 is within the scope of the present invention.
[0076] For example, and as illustrated in FIG. 11A, the helical pattern of guide line 1120 begins outside the expandable implant 1106 near the distal end on the outer curve of the expandable implant 1106 and ends proximal thereto within the expandable implant curve 1106. The guide line 1120 continues on the curve internally in a direction substantially parallel to the central axis of the expandable implant 1106 and toward the proximal end of the inner curve of the expandable implant 1106. From the proximal end, the direction line 1120 enters the expandable implant 1106 and returns to the distal end, on the outer curve. of the expandable implant 1106, where it is locked with a distal pin. Fig. 11B illustrates a similar configuration, in which, as tensile forces F is applied to the guideline 1120, but in which the guideline is threaded 1120 and locked in an opposite configuration.
[0077] In various embodiments, the direction lines may travel a path through and/or across the expandable implant surface that is at least partially parallel and substantially covered by one or more gloves.
[0078] In various embodiments, the catheter assembly may further comprise a lock wire. In these presentations, the locking wire can provide a guideline or lines for the catheter assembly. For example, with reference to FIG. 8, catheter assembly 800 includes a catheter shaft 802, expandable implant 806, two guide lines 820, and a locking wire lock 880 880 passages outside the patient's body, through catheter shaft 802, and the exits to a point near the tip of the 818 catheter At this point, it interacts with the 820 direction lines, then re-enters the axis of the 802 catheter and continues to the 818 catheter tip. In such a configuration, the locking wire releasably couples 880 couples directing lines 820 of catheter assembly 800 Any mode in which it locks wire 880 may interact with guide line or lines 820 to releasably maintain a connection between guide line or lines 820 and catheter assembly 800 se is within the scope of the present invention.
[0079] In various embodiments, each guideline may further comprise an end circuit. For example, with reference to FIG. 9, each guide line 920 comprises an end circuit 922 of the lock wire 980 may pass through each end of loop 922, ensuring each guide line 920 of catheter assembly 900 Any method of securing line or guide lines 920 of catheter assembly 900 falls within the scope of the invention.
[0080] In various embodiments, the interlocking wires can be formed from metallic, polymeric or natural materials and can include conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochloroethylene on PVC and polyurethane, organosilicon elastomeric polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol. Elongated members or locking wires can also be formed from high strength polymer fibers such as ultra high molecular weight polyethylene fibers (eg Spectra, Dyneema Purity®, etc.) or aramid fibers (by example, Technora, etc).
[0081] In various embodiments, a catheter assembly used to provide an expandable implant comprises a catheter shaft, an expandable implant, one or more gloves, one or more guide lines, and a locking wire. In such configurations, the expandable implant is capable of flexion, tension applied across one or more lines of direction and corresponding displacement, to conform to the curvature in a patient's vasculature.
[0082] For example, with reference to Figs. 5A-D, a catheter assembly 500 comprising an expandable implant 506 is illustrated. Catheter assembly 500 further comprises two guide lines 520, a lock wire 580, a primary coupling member 524, and a secondary coupling member 534. Primary coupling member 524 is released coupled to main sleeve 504. coupling member Secondary 534 is released coupled to secondary sleeve 508.
[0083] The catheter set 500 is inserted into a patient's vasculature, and the expandable implant 506 is advanced to a treatment area of the vasculature. Upon arriving at a location close to the treatment area, primary coupling member 524 can be detached from primary sleeve 504, allowing expandable implant 506 to be expanded to an intermediate configuration. In various embodiments, the sleeve 504 can be removed from the coupling member once the primary vasculature 524 has been disengaged.
[0084] With reference to FIG. 5B, after expansion to an intermediate configuration, tension can be applied to guide lines 520, causing the expandable implant 506 to bend in a desired manner. For example, the expandable implant 506 may bend in a direction aligned with the location of guide lines 520. Once the expandable implant 506 has been sufficiently bent, tension is applied in accordance with the guide lines 520 to maintain the grade. of curvature.
[0085] In various embodiments, tension can be applied to guide lines 520 by pulling the lines outside the patient's body. In another embodiment, guide lines 520 may be connected to one or more dials, or other mechanisms for applying tension to the rear end of catheter shaft 502 In this configuration, the connection may be used to apply the desired tension, as well as maintaining the correct amount of tension once a desired flexion angle of the expandable implant 506 has been achieved. Various embodiments may also comprise an indicator, scale, gradient, or the like, which shows the amount of tension or displacement of the direction line, and/or the amount of curvature in the expandable implant 506. In various embodiments, the assembly The catheter may comprise a further marking (e.g. on an identifier) that allow a user to determine the orientation of the guideline with respect to the vasculature.
[0086] After a sufficient degree of flexion is performed on the expandable implant 506, the implant can be rotated into the final position in the area of treatment of the vasculature. In various exemplary embodiments, locking wire 580 is engaged with guide lines 520 such that torsional rotation of the catheter axis causes the expandable implant 506 to rotate within the vasculature. However, any configuration of catheter assembly 500 that allows rotation of the expandable implant 506 is within the scope of the present invention.
[0087] In various embodiments, an expandable implant may further comprise one or more radio-opaque markers. In one embodiment, one or more radio-opaque markers form a band around the distal end of the expandable implant. In these configurations, radiopaque markers can aid in the implantation of an expandable implant, providing greater visibility when viewing the expandable implant with a radiographic device such as an x-ray machine. Any arrangement of radiopaque markers that aids in the implantation of an expandable implant is within the scope of the present invention.
[0088] In various embodiments, the radiopaque markers can assist in orienting the expandable implant through a profile view of the distal end of the expandable implant. For example, with reference to FIG. 4, a series of potential profiles 491-495 of the distal end of an expandable implant 406 are illustrated. In such configurations, radiopaque markers located at the distal end of the expandable implant 406 provide a profile view of the distal end of the expandable implant 406 when viewed by a radiographic device. Such profile visits can be used to correctly orient the 406 Expandable Implant, assisting the user in determining the degree of rotation and/or orientation of a curve in the 406 Expandable Implant.
[0089] For example, profile 491 represents a distal end of an expandable implant 406 with an orientation substantially orthogonal to a radiographic image capture device such as an x-ray camera. Profile 492 represents a distal end of an expandable implant with an orthogonal orientation less than profile 491 of profile 493 represents a distal end of an expandable implant 406 has an orthogonal orientation less than profile 492. Finally, profile 494 represents a distal end of an expandable implant 406 that has an orientation parallel to a radiographic image capture device.
[0090] After the expandable implant 506 has been properly oriented and located within the patient's treatment area, secondary coupling member 534 can be uncoupled from secondary sleeve 508. Once secondary coupling member 534 is uncoupled from secondary sleeve 508, expandable implant 506 can be expanded to a final position and diameter within the treatment area. In various exemplary embodiments, the secondary glove 508 is removed from the vasculature. In other exemplary embodiments, the secondary sleeve 508 remains in a circumferential position around a portion of the expandable implant 506.
[0091] With reference to FIG. 5C, after expandable implant 506 is in the expanded position and in the vasculature, lockout wire 580 can be disengaged from catheter assembly 500. In various embodiments, lockout wire 580 is disengaged, applying sufficient tension to the wire. lock 580 from the outside of the patient's body. After locking wire 580 is disengaged, guide lines 520 can be released from engagement with catheter shaft 502 and can be removed from expandable implant 506 and mounting catheter 500.
[0092] As illustrated in FIG. 5D, after the primary and secondary coupling members 524 and 534, guide lines 520, 580, and locking wire are removed from catheter assembly 500, catheter assembly 500 is fully disengaged from expandable implant 506, and can be removed at from the patient's vascular system.
[0093] It is evident to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover modifications and variations of the present invention, provided they come within the scope of the appended claims and their equivalents.
[0094] Likewise, numerous features and advantages have been established in the previous description, including several alternatives, along with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications can be made, in particular with regard to structure, materials, members, limbs, shape, size and arrangement of parts, including combinations within the principles of the disclosure, to the extent indicated by the broad meaning , general of the terms in which the claims are expressed. Insofar as these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be covered therein.

权利要求:
Claims (25)
[0001]
1. Catheter assembly comprising: a catheter having a leading end and a trailing end and comprising a main lumen extending between the leading end and the trailing end; an expandable device positioned at the forward end of the catheter, the expandable device having a closed configuration for endoluminal delivery of the expandable device to a treatment site, and an expanded configuration having a diameter greater than the diameter of the closed configuration; a primary glove wrapped circularly around the expandable stent graft, wherein the primary glove comprises a sheet of material having first and second main surfaces and a plurality of openings extending from the first main surface to the second main surface; and a primary coupling member cooperating with the apertures to releasably couple the portions of the sheet together to constrain the expandable stent graft toward the closed configuration; and at least one guide line extending through the main lumen of the catheter and at least disposed between the expandable device and the primary sleeve to allow selective folding of the expandable device and non-concentric coupling of the expandable implant with respect to the catheter and into helical transition between the distal end and the proximal end towards an inner curve of the expandable device.
[0002]
2. Catheter assembly according to claim 1, characterized in that the at least one guiding line begins at a distal end of the expandable device in an outer curve of the expandable device, wherein the at least one guiding line ends in a proximal end of the expandable device on the inner curve of the expandable device.
[0003]
Catheter assembly according to claim 2, characterized in that the at least one guideline comprises a first guideline and a second guideline.
[0004]
4. Catheter assembly according to claim 3, characterized in that the first direction line mirrors the second direction line through a sagittal plane through an axis of the expandable device.
[0005]
5. Catheter assembly according to claim 1, characterized in that the at least one direction line begins outwardly at a distal end of the expandable device in an outer curve of the expandable device, wherein the at least one steering line helically transitions between the distal end and the proximal end toward an interior curve of the expandable device, wherein the at least one steering line enters an interior of the expandable device at a proximal end of the expandable device on the interior curve of the expandable device, wherein the at least one guidance line returns from the proximal end of the expandable device towards the distal end of the expandable device, and wherein the at least one guidance line is attached to the distal end of the device expandable with a distal pin.
[0006]
The catheter assembly of claim 2, further comprising a secondary sleeve and a secondary coupling member, wherein the secondary sleeve limits the expansion of the expandable device to an intermediate configuration having a diameter greater than the diameter of the closed configuration and smaller than the diameter of the expanded configuration.
[0007]
Catheter assembly according to claim 2, characterized in that the expandable device comprises a stent graft.
[0008]
The catheter assembly of claim 7, characterized in that the stent graft comprises at least one apex, and wherein the at least one guideline is woven across the at least one apex of the stent graft. .
[0009]
9. Catheter assembly according to claim 2, characterized in that the at least one guideline is removable.
[0010]
10. Catheter assembly according to claim 2, characterized in that the expandable device is releasably coupled to the catheter.
[0011]
The catheter assembly of claim 10, further comprising a locking wire extending through the main lumen, wherein the locking wire releasably engages with the at least one guide line.
[0012]
A catheter assembly according to claim 6, characterized in that the at least one guide line is disposed within the secondary sleeve such that when the catheter assembly is inserted into a vessel, the at least one steering line remains covered by the secondary sleeve.
[0013]
A catheter assembly according to claim 6, characterized in that the at least one guide line is disposed within the secondary sleeve such that when the catheter assembly is inserted into a vessel, the at least one line steering does not directly contact the tissue inside the vessel.
[0014]
The catheter assembly of claim 2, characterized in that the expandable device is bendable more than about 90 degrees with respect to an axis of the catheter.
[0015]
15. Catheter assembly according to claim 2, characterized in that the degree of curvature of the expandable device in relation to an axis of the catheter is proportional to the amount of tension in the at least one line of direction.
[0016]
16. Catheter assembly according to claim 2, characterized in that the degree of flexion of the expandable device in relation to an axis of the catheter is proportional to the amount of displacement of the at least one direction line.
[0017]
The catheter assembly of claim 2, characterized in that the expandable device substantially maintains a desired radius of curvature while the expandable device is deployed in an expanded configuration.
[0018]
Catheter assembly according to claim 2, characterized in that the at least one guideline is connected to the proximal end of the expandable device.
[0019]
The catheter assembly of claim 2, further comprising a radiopaque marker located at the proximal end of the expandable device.
[0020]
20. Catheter assembly according to claim 19, characterized in that the radiopaque marker comprises a band that extends around a perimeter of the expandable device.
[0021]
21. Catheter assembly according to claim 19, characterized in that the catheter assembly is seen with a radiographic device located outside a patient's body, and wherein, when the expandable device is correctly positioned within the treatment site, a profile of the two-dimensional radiopaque marker is substantially a line.
[0022]
22. Catheter assembly according to claim 2, characterized in that the at least one guideline torsionally anchors the expandable device and the catheter allows rotational positioning of the device at the treatment site by means of rotation of the catheter.
[0023]
The catheter assembly of claim 6, further comprising first and second secondary restraint members, wherein the first secondary coupling member is threaded along approximately half the length of the secondary sleeve and the second coupling member secondary is threaded along the other approximately half of the secondary sleeve.
[0024]
The catheter assembly of claim 2, further comprising a secondary coupling member and a plurality of secondary openings, wherein the secondary coupling member cooperates with the secondary openings to releasably couple portions of the sheet to a with each other to constrain the expandable device to an intermediate configuration, the intermediate configuration having a larger diameter than the closed configuration and smaller than the expanded configuration.
[0025]
25. Catheter assembly comprising: a catheter having a leading end and a trailing end and comprising a main lumen extending between the leading end and the trailing end; an expandable device positioned at the forward end of the catheter, the expandable device having a closed configuration for endoluminal delivery of the expandable device to a treatment site and an expanded configuration having a diameter greater than the diameter of the closed configuration; a primary glove wrapped circumferentially around the expandable stent graft, wherein the primary glove comprises a sheet of material having first and second main surfaces and a plurality of apertures extending from the first main surface to the second main surface; a primary coupling member cooperating with the apertures to releasably couple portions of the sheet together to limit the expandable insert toward the closed configuration; and at least one guideline extending through the main lumen of the catheter and extending generally helically around the expandable device between the expandable device and the primary sleeve to allow for the bending of the expandable device in response to selective tensioning of the , at least one direction line.

类似技术:

公开号 | 公开日 | 专利标题

BR112014022291B1|2021-08-24|CATHETER SET

AU2015207853B2|2017-07-27|External steerable fiber for use in endoluminal deployment of expandable devices

US20180071126A1|2018-03-15|External steerable fiber for use in endoluminal deployment of expandable devices

ES2881102T3|2021-11-26|Steerable catheter for use in endoluminal deployment of expandable devices

同族专利:

公开号 | 公开日

KR20140139554A|2014-12-05|

EP3205314A2|2017-08-16|

ES2748099T3|2020-03-13|

CN106344208A|2017-01-25|

JP6835769B2|2021-02-24|

CA2950600C|2019-10-22|

ES2628344T3|2017-08-02|

JP6346165B2|2018-06-20|

EP2825137B1|2017-04-19|

EP3205314B1|2019-08-07|

CN106344208B|2020-10-09|

JP2018143787A|2018-09-20|

JP2015513926A|2015-05-18|

US20180036113A1|2018-02-08|

AU2013232766A1|2014-09-18|

EP3205314A3|2017-12-06|

US11123174B2|2021-09-21|

AU2013232766B2|2016-01-14|

US20130245742A1|2013-09-19|

US9770322B2|2017-09-26|

US20140081376A1|2014-03-20|

US9375308B2|2016-06-28|

CA2866687A1|2013-09-19|

EP2825137A1|2015-01-21|

HK1204280A1|2015-11-13|

WO2013137977A1|2013-09-19|

CA2950600A1|2013-09-19|

RU2014141048A|2016-04-27|

BR112014022291A2|2020-09-24|

CA2866687C|2017-01-17|

CN104244876A|2014-12-24|

CN104244876B|2016-10-19|

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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]|

2020-10-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-06-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-08-24| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/01/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US201261610372P| true| 2012-03-13|2012-03-13|

US61/610.372|2012-03-13|

US13/743,118|US9375308B2|2012-03-13|2013-01-16|External steerable fiber for use in endoluminal deployment of expandable devices|

US13/743.118|2013-01-16|

PCT/US2013/022404|WO2013137977A1|2012-03-13|2013-01-21|External steerable fiber for use in endoluminal deployment of expandable devices|

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