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    • 专利摘要:
    aneurysm device and delivery system. The present invention relates to a self-expanding braid for treating an aneurysm. The braid may include a lumen with a proximal end opposite a distal end. translation of the braid may cause a distal segment of the braid to expand and form an outer occlusive sac while a proximal segment to the distal segment may invert into the outer occlusive sac like a tube sock. The braid can then be separated from its application system.
    公开号:BR102018076836A2
    申请号:R102018076836-0
    申请日:2018-12-21
    公开日:2019-07-02
    发明作者:Juan Lorenzo
    申请人:DePuy Synthes Products, Inc.；
    IPC主号:
    专利说明:

    Descriptive Report of the Invention Patent for DEVICE FOR ANEURISM AND APPLICATION SYSTEM.
    FIELD OF THE INVENTION [0001] This description refers to medical instruments, and more particularly, to application systems for aneurysm therapy. BACKGROUND OF THE INVENTION [0002] Aneurysms can be complicated and difficult to treat. For example, access to treatment may be limited or unavailable when an aneurysm is located close to critical tissues. Such factors are of particular concern with cranial aneurysms due to the brain tissue surrounding the cranial vessels that have corresponding limited access to treatment.
    [0003] Previous solutions included access to endovascular treatment so that an internal volume of the aneurysm sac is removed or excluded from arterial pressure and blood flow. In this respect, due to the fact that the inner walls of the aneurysm can continue to be subjected to blood flow and related pressure, rupture of the aneurysm remains possible.
    [0004] Alternatives to the endovascular approach or other surgical approaches may include occlusive devices. Such devices typically incorporate multiple embolization springs that are applied to the vasculature using microcatheter delivery systems. For example, when treating cranial aneurysms, an application catheter with embolization springs is typically inserted first into the non-cranial vasculature through a femoral artery in the hip or groin area. After that, the catheter is guided to a place of interest within the skull. The aneurysm sac can then be filled with embolic material to create a thrombotic mass that protects the arterial walls from blood flow and related pressure. However, such occlusive devices have certain disadvantages, including the effect of
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    2/24 mass, which can cause compression in the brain and its nerves.
    [0005] A specific type of occlusive approach strives to apply and treat the entrance or neck of the aneurysm as opposed to the volume of the aneurysm. In such neck approaches, by minimizing blood flow through the neck, then a cessation of flow into the aneurysm can be achieved. In turn, a thrombotic mass can form naturally without having to apply embolic materials, as previously described. This is preferable for masses formed from embolic material, since a natural mass can improve healing by reducing possible distension of the arterial walls and allows reintegration into the original shape of the parental vessel along the plane of the neck of the aneurysm. It is understood that the neck plane is an imaginary surface on which the innermost layer of the parental wall would be only for the aneurysm. However, occlusive neck approaches are not without disadvantages. It is desired to block the neck of the aneurysm in the parental vessel. In addition, embolization springs do not always treat aneurysms effectively, since aneurysm recanalization and / or spring compression can occur over time.
    [0006] The solution of this description solves these and other problems of the technique.
    SUMMARY OF THE INVENTION [0007] In some respects, the present invention relates to a self-expanding braid to treat an aneurysm. The braid can include a lumen with a distal end opposite to a proximal end. The translation of the braid can cause the application portion to expand and form an occlusive bag as well as to invert and bend itself, thus occluding an aneurysm.
    [0008] In certain embodiments, an occlusive device is provided
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    3/24 to treat an aneurysm. The device may include an application system and a braid that is slidably disposed within the microcatheter in a retracted state. The braid can have a distal end opposite to a proximal end. The braid can include a distal segment between the distal and proximal ends. The braid can be translatable distally from inside the microcatheter to an implanted state. The braid can expand to the implanted state as the distal end of the braid exits the microcatheter, causing the distal segment to expand radially to form an occlusive sac for the aneurysm.
    [0009] In some modalities, the distal segment is able to be arranged through the neck of the aneurysm, in which the distal segment may include reduced porosity in relation to the occlusive sac, thus deflecting, deflecting and / or slowing a flow in the aneurysm. [0010] In some modalities, the distal segment is able to be arranged through the neck of the aneurysm, in which the distal segment may include a higher braid angle in relation to the occlusive sac. [0011] In some modalities, moving the braid distally after the occlusive bag is formed causes one or more segments proximal to the distal segment to invert and fold into the occlusive bag. In some embodiments, the one or more segments proximal to the distal segment have an increased braid angle in relation to a distal segment braid angle to facilitate inversion. In some modalities, in the implanted state, the braid is removable from the application system in the aneurysm. The delivery system can also include an delivery tube with a distal end and a proximal end. The distal end of the application tube can be removably connected to the proximal end of the braid so that the application tube can be
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    4/24 translatable inside a microcatheter. The application tube can transfer the braid distally inside the microcatheter from the retracted state to the implanted state.
    [0012] In some embodiments, the braid may include a tapered segment disposed between the distal segment and a proximal segment that can be elongated (for example, partial, substantial and / or totally). The tapered segment can have a tapered shape. The proximal segment can be arranged on or adjacent to the proximal end of the braid. The occlusive bag of the distal segment can be spherical or of any other suitable shape to occlude the aneurysm when in the implanted, expanded state. The distal segment can form in the occlusive bag of the braid, which can be located in the neck area of the aneurysm, making the distal segment remain in place in the aneurysm, and the proximal segment translates distally, eventually inverting in the segment distal. The occlusive sac may be able to seal the aneurysm's neck. In some embodiments, the tapered segment is operable to cover the neck of the aneurysm and the proximal segment can be operable to bend into the occlusive sac formed by the distal segment. The tapered segment can deflect the flow or slow the flow into the aneurysm. The proximal segment can attach the braid to the distal end of the delivery tube and, after the distal segment has expanded to form the occlusive bag, it can initiate the inversion of the proximal end of the braid into the occlusive bag of the distal segment. In one embodiment, the inversion of the proximal end works like a tube sock in the distal segment.
    [0013] In some embodiments, the occlusive bag of the distal segment may be a retractable cage-type vessel-occlusive structure. In some embodiments, the braid may include one or more portions of buckling defined between the distal segment and the tapered segments
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    5/24 and / or proximal. In this sense, the proximal end of the overlapping braid internal to the occlusive bag of the distal segment can be formed by inversion in the buckling portion, as the braid continues to translate distally from the microcatheter and after the occlusive bag of the distal segment has been formed by the radial expansion. The distal segment may also include fewer wire segments than the tapered and proximal segments.
    [0014] In some modalities, each of the distal, tapered and proximal segments can include different braiding properties. [0015] In some modalities, the tapered segment diverts the flow as the distal segment forms the adjacent occlusive sac or is against an aneurysm wall and the proximal segment is inverted in the distal segment in the aneurysm neck.
    [0016] In some modalities, an imaging device is in operational communication with the occlusive device, in which the imaging device is capable of imaging the sac in relation to the aneurysm. An orientation of the occlusive bag can be adjusted by the braid being distal or proximally moved.
    [0017] In some modalities, a braid is provided to treat an aneurysm. The braid can have a distal segment defined between the proximal and distal ends of the braid. The braid can also have a tapered segment arranged between the distal segment and a proximal segment. The proximal segment can be arranged on or adjacent to the proximal end. The braid may be able to move from a retracted state within a microcatheter to an implanted state external to the microcatheter. In this modality, the translation of the braid so that the distal end is distal to the microcatheter causes the distal segment to expand radially and form an external occlusive sac. The occlusive bag may have a diameter greater than a diameter of the microcatheter. Additionally, the translation of the braid distally
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    6/24 after the external occlusive bag is formed can cause the tapered segment to reverse into the occlusive bag.
    [0018] In some modalities, the braid may be removable by means of a system applied to an aneurysm. The lumen of the braid may also include a buckle portion arranged between the distal segment and the tapered and / or proximal segments. The buckling portion can cause the tapered segment to reverse into the occlusive bag. In some embodiments, a braid angle of the tapered segment can be adjusted (for example, increased) compared to a braid angle of the distal segment.
    [0019] In some embodiments, a method for applying an occlusive device to an aneurysm in a blood vessel in a patient is disclosed. The method may include sliding an application tube into a microcatheter; slidingly position a braid with the application tube, where the braid is in a retracted state and comprises a distal end and a proximal end; selectively position the microcatheter, the delivery tube and the braid in the vasculature of the aneurysm; slide the braid distally through the application tube of the microcatheter towards the aneurysm; cause a distal segment between the proximal and distal ends of the braid to move from the retracted state within the microcatheter to an implanted state defined by the distal segment expanding radially to form an occlusive sac as the distal end of the braid is moved distally from the microcatheter ; invert a segment close to the distal segment in the occlusive sac; and release the braid inside the aneurysm and remove the application tube and microcatheter from the aneurysm.
    [0020] In some modalities, the inversion of the proximal segment
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    7/24 to the distal segment in the occlusive sac can deflect, deflect and / or slow down a flow in the aneurysm.
    [0021] In some modalities, the method may include imaging the occlusive bag of the braid with respect to the aneurysm; determine whether the aneurysm is occluded by the sac; and distally or proximally slide the braid to adjust the sac and occlude the aneurysm.
    [0022] In some modalities, the method may include adjusting (for example, increasing) a braid angle of the proximal segment; positioning said segment adjacent or in communication with an aneurysm neck; and deflect, deflect and / or slow a flow to the aneurysm when the proximal segment is inverted into the occlusive sac.
    [0023] In some modalities, the method may include sealing the aneurysm's neck by the occlusive bag.
    [0024] In some modalities, the method may include positioning the distal segment through an aneurysm neck; and reduce the porosity of the distal segment in relation to the occlusive sac.
    [0025] In some modalities, the method may include positioning the distal segment through an aneurysm neck; and providing a higher braid angle in relation to the occlusive bag.
    [0026] Other aspects and characteristics of the present invention will be evident to those skilled in the art, through the analysis of the detailed description below, together with the attached figures.
    BRIEF DESCRIPTION OF THE DRAWINGS [0027] Reference will now be made to the associated drawings, which are not necessarily drawn to scale.
    [0028] Figure 1 shows an occlusive device exemplifying this description implanted in an aneurysm;
    [0029] Figure 2 is a schematic side view of an exemplifying application system with an occlusive device in communication
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    8/24 inside a microcatheter;
    [0030] Figure 3 is an enlarged schematic side view of the braid of Figures 1 to 2 in an expanded state;
    [0031] Figure 4A is an enlarged schematic side view of the application system and the braid of Figures 1 to 3 as the braid is being pushed into an exemplary aneurysm; [0032] Figure 4B is an enlarged schematic side view of the application system and the braid of Figures 1 to 3 as the braid is being pushed into an exemplary aneurysm; [0033] Figure 5A is an enlarged schematic side view of the application system and the braid of Figures 1 to 3 as the braid is being pushed into an exemplary aneurysm; [0034] Figure 5B is an enlarged schematic side view of the application system and the braid of Figures 1 to 3 after the braid has been implanted in an exemplary aneurysm;
    [0035] Figure 6A is a schematic perspective view showing an exemplary application system for use with an exemplary occlusive device;
    [0036] Figure 6B is a schematic perspective view of Figure 6A, but with partial cross section of the application system and the occlusive device;
    [0037] Figure 7A is a schematic perspective view of Figures 6A to 6B being implanted with partial cross section of the application system and the occlusive device;
    [0038] Figure 7B is a schematic perspective view of Figures 6A to 6B implanted with the exemplifying application system separate from the occlusive device;
    [0039] Figure 8 is a flow diagram for a method of applying an occlusive device; and
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    9/24 [0040] Figure 9 is a flow diagram for a method of applying an occlusive device.
    DETAILED DESCRIPTION [0041] Although exemplary modalities of the disclosed technology are explained in detail in the present invention, it should be understood that other modalities are contemplated. Therefore, it is not intended that the disclosed technology be limited in scope to the details of construction and arrangement of components set out in the following description or illustrated in the drawings. The technology revealed is capable of other modalities and can be practiced or performed in several ways.
    [0042] It should also be noted that as used here and in the appended claims, the singular forms one, one, o and a include the respective plural forms, unless the context clearly determines otherwise. By comprising or containing or including it is understood that at least the mentioned compound, element, particle or method step is present in the composition, article or method, but does not exclude the presence of other compounds, materials, particles or steps method, even if the other such compounds, materials, particles or steps of the method have the same function as the named one.
    [0043] In the description of the exemplifying modalities, the terminology will be used for the sake of clarity. It should be understood that each term contemplates its broadest meaning, as understood by those skilled in the art, and includes all technical equivalents that operate in a similar way to accomplish a similar purpose. It should also be understood that the mention of one or more steps of a method does not exclude the presence of additional steps of the method or intermediate steps of the method between those steps expressly identified. The steps of a method can be performed in
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    10/24 an order different from that described here without departing from the scope of the technology presented. Similarly, it should also be understood that the mention of one or more components in a device or system does not exclude the presence of additional components or intermediate components between those components expressly identified.
    [0044] As discussed in this document, the vasculature of an individual or patient can be the vasculature of a human or an animal. It should be noted that an animal can be a variety of any applicable type, including, but not limited to, mammals, veterinary animals, pets or livestock, etc. For example, the animal may be a laboratory animal specifically selected to have certain characteristics similar to those of a human being (for example, rat, dog, pig, monkey or the like). It should be noted that the individual can be, for example, any suitable human patient.
    [0045] As discussed in the present invention, an operator can include a doctor, surgeon or any other individual or application instrument associated with the application of a braided body to an individual's vasculature.
    [0046] The occlusive device 1 and the corresponding application system 40 disclosed here address the disadvantages of the previous approaches. Returning to Figure 1, an occlusive device 1 exemplifying this description is shown implanted in an aneurysm A of the blood vessel BV, but not yet released from the delivery system 40. The delivery system 40 can include a microcatheter 20 with an application tube 30 slidably arranged on it. In Figure 1, microcatheter 20 had been applied to aneurysm A and an occlusive sac formed by the distal segment 12 of the braid 10 is shown forming
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    11/24 a predetermined shape and the structure that contours and supports the walls of aneurysm A in order to occlude aneurysm A. Segment 12 can be formed on, with, or otherwise around the distal end 14 of the braid 10. The size of the microcatheter 20 is selected taking into account the size, shape and direction of the aneurysm or body lumens that the catheter needs to pass to reach the treatment site. Microcatheter 20 can have a total useful length anywhere from 80 centimeters to 170 centimeters. Microcatheter 20 can have an internal diameter DI anywhere between 0.038 and 0.081 centimeters (0.015 and 0.032 inches). The outer diameter DE can also vary in size and may narrow at its proximal or distal end. At its proximal end 26, microcatheter 20 can be attached to another device, and at its distal end 24 it can be operable to be positioned on the neck of aneurysm A. Although the distal end 24 of microcatheter 20 as shown contains the braid 10, the end 24 can vary in shape and can curve at an angle. [0047] Returning to Figure 2, a schematic side view of the braid 10 and the application system 40 is shown in an implanted configuration, but before being positioned in a location of interest in the vasculature. The system 40 may include an delivery tube 30 and a microcatheter 20. The delivery tube 30 may be able to be pushed distally from a microcatheter 20 and the delivery tube 30 may have an internal lumen. The delivery tube 30 can be substantially elongated and can extend from the proximal end 26 to the distal end 24 of the microcatheter 20. The tube 30 can, in general, extend along the inner lumen of the microcatheter 20 and can leave a space between its outer surface and the inner surface of the microcatheter 20. In turn, the delivery tube 30 and the microcatheter 20 can be axially aligned. System 40 can apply the braid
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    12/24 at a site of interest (for example, an injury site) using microcatheter 20. In certain embodiments, microcatheter 20 can be pre-placed at a level in the neck of the aneurysm and used to track device 1 to the lesion. The application tube 30 can be in mechanical connection with the braid 10 in the locking portion 54. The braid 10 can be fixed to the locking portion 54 by sliding fixation, permanent fixation (for example, crimped, laser, ultrasonic welding, or other heat sources, adhesive or the like) or other removable fixation approaches. When the delivery tube 30 is mechanically attached to the braid 10 in the locking portion 54, moving distally, sliding, or otherwise moving the tube 30 towards aneurysm A may cause the braid 10 to begin to move from a condition retracted inside the microcatheter 20 to a condition implanted externally to the microcatheter with the segment 12 occlusive sac, as discussed more particularly below.
    [0048] The inner lumen of the braid 10 may include a distal end 14 and a proximal end 16. The distal end 14 may be open and / or capable of allowing sizing or adaptation to aneurysm A. For example, if the aneurysm is relatively small, the distal end 14 can be a closed end, while in a larger aneurysm, the same braid 10 can have an open distal end 14. The inner lumen of the braid 10 can be formed from an invertible and multi-filament outer surface self-expanding that can include a network. The occlusive bag of the braid 10 can be formed during implantation as the distal end 14 of the braid 10 slides out and leaves the microcatheter 20. The braid net 10 can be defined by one or more net patterns with net openings defined by braided filaments. For example, the braid 10 can include a region of porosity associated with the occlusive bag formed by the braid 10. The braid 10 can be
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    13/24 comprised of a mesh tube, closed at one end (for example, proximal end 16) and can be produced from various materials such as deposited thin films. The self-expanding braid network 10 can include multiple strands, for example, from 4 to 96 strands. The number of threads can be a factor in controlling the material properties of braid 10, including hardness.
    [0049] The occlusive bag of the braid 10 can be formed by the braid 10 being transferred distally from a retracted state inside the microcatheter 20 and fixed to the application tube 30. The braid net 10 is configured so that, according to the braid 10 it is distally translated and its end 14 comes out of the microcatheter 20, the segment 12 will immediately begin to expand. As the braid 10 is additionally translated, the braid segments 10, including the segment 12 and its corresponding occlusive bag, will take shape. Fewer strands of braid 10 can be used as a whole. The wires can be produced from multiple alloys such as a nickel-titanium alloy, cobalt-chromium alloys, platinum, nitinol, stainless steel, tantalum or other alloys, or any other suitable biocompatible materials, or a combination of these materials. In addition, these materials may be absorbable or non-absorbable by the patient over time.
    [0050] The openings in the braid 10 can also create a substantially unitary structure or net. In this way, the openings can be of any size, shape or porosity, and can be evenly or randomly spaced across the wall of the braid mesh 10. The openings can provide flexibility to the tubular element of the braid 10 and also help in transforming the mesh of the braid. retracted state to the expanded, implanted state, and vice versa.
    [0051] Returning to Figure 3, an enlarged schematic side view of the braid 10 of Figures 1 to 2 is shown in an expanded state, from
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    14/24 close. Other portions of the braid 10 can have different porosities and / or other material properties, including segments 11 and 13 of braid 10. Braid 10 can include several segments, including a generically spherical shape segment associated with bag 12 together with a proximal tapered cone segment 13 leading to a relatively elongated proximal segment 11. Segment 11 of braid 10 may have less porosity than the porosity of segment 13 and / or the bag segment 12. The porosities associated with segments 11, 12, 13 and / or any other region or braid segment 10 include filaments that have modified braid angles in the respective respective regions. For example, the braiding angle can be modified by removing filaments in the respective region or by adding a coating or covering to a respective region or by selective modification of the cross section of the threads. Braid portions 10 at or near end 16 may be more malleable than braid portions 10 at adjacent end 14 in order to induce self-expansion during application and inversion as braid 10 forms its predetermined bag-like shape within the aneurysm A (see, for example, segment 12). The outer surface of the braid 10 can also be produced from nitinol with interwoven platinum filaments for radiopacity. The tapered segment 13 adjacent to the spherical segment 12 can allow the braid 10 to invert itself (like a sock) as the device 1 is fully implanted in the aneurysm A. To facilitate the inversion of the braid 10 in the segment 13, the braid 10 it can be modified to weaken or make it more likely to reverse. For example, segment 13 may include a buckle portion 17 that includes a change of localized braid angle, removal of thread segments, localized heat treatment and other approaches to changing properties 870190015044, 02/14/2019, pg . 17/46
    15/24 braiding activities. In certain embodiments, the braid angle of segment 13 can be increased in relation to other portions of braid 10 so that the porosity of braid 10 across the neck is reduced so that a flow into the aneurysm is deflected, deflected or slowed . This is due to the fact that segment 13 may be in communication with the neck of the aneurysm when braid 10 is inverted and implanted in the aneurysm, since the end 16 can be folded into segment 12 (for example, see Figure 5B).
    [0052] In certain embodiments, a braid angle of one or some of the segments 11, 12, 13 of braid 10 can vary from the longitudinal geometric axis of the braid 10. The diameter of the yarn, number of passes (that is, the number of wire intersections per linear measurement) of braid 10 may also vary or otherwise be modified between the braid segments 10 to change the characteristics of the device. The shape of the braid 10 and any of its respective segments can also be adjusted by heat. The fibers of the braid 10 can be formed by being fixed at their free ends by hot bonding by laser or ultrasonic welding, bonding by solvent or adhesive, crimping or any other means of fixation. The fibers of each braid segment 10 can be bonded at their internal intersection points by solvent, adhesive, or heat bonding, such as laser, ultrasonic soldering, or any other heat source. However, braid 10 is not limited to this and can have a braid angle, step count, wire diameter, porosity or any other braid property 10 that is substantially similar throughout.
    [0053] Figures 4A to 5B show an enlarged schematic side view of the application system 40 and the braid 10 as the braid 10 is being pushed into an exemplary aneurysm. The mesh of braid 10 expands and then the proximal end 16 reverses in
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    16/24 braid 10 as the occlusive bag of segment 12 of braid 10 is formed. This means that braid 10 inverts along segment 11 in and rests within the aneurysm bag as soon as it has been implanted. In one example, the inversion of the braid 10 net can be formed when the end 14 of the braid 10 is relatively fixed against the wall of aneurysm A while the end 16 is distally pushed forward away from the microcatheter 20 and folded into the bag of segment 12. In certain embodiments, the proximal end 16 of the braid 10 can begin to reverse as the braid 10 moves distally forward as shown in Figure 4B and the braid 10 does not need the entire length of 10 to be implanted before the braid start inversion. In other embodiments, since the entire length of the braid 10 is implanted and distal from the microcatheter 20, the proximal end 16 can invert and bend into the segment 12. Regardless, in the implanted state, once selectively positioned and arranged in the implanted configuration with respect to the aneurysm, braid 10 can be separated. The inversion of the braid 10 can be formed in a tube sock. In other embodiments, since the braid 10 is fully implanted and the occlusive bag of the braid 10 is formed inside aneurysm A, both ends 14, 16 can be close to or adjacent to each other.
    [0054] Before the arrangement of Figure 4A, the braid 10 can be mounted with an application tube 30 and / or inside a microcatheter 20 in a retracted state. In that regard, the innovative application system 40 and the innovative braid 10 disclosed herein can be packaged as a kit or portable system. The assembly between the microcatheter 20, the application tube 30 and / or the braid 10 can occur before being introduced into the vasculature. Application system 40 used with braid 10, which may include microcatheter 20 and application tube 30,
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    17/24 can be selectively positioned at the site of the lesion and the application tube 30 can begin to move the braid 10 distally towards the aneurysm. Braid 10 can expand according to or by contacting its application end 14 with aneurysm A as it moves distally away from the distal end 24 of catheter 20 to form the spherical sac associated with segment 12 within aneurysm A. As shown in Figure 4A, segment 12 of braid 10 begins to have a generally spherical shape internal to aneurysm A, since braid 10 comes into contact with the dome of aneurysm A and / or as the braid is moved distally deeper into aneurysm A, further from catheter 20 and tube 30. The delivery tube 30 can also include one or more operable fasteners to securely hold braid 10 in place prior to implantation.
    [0055] As shown in Figure 4A, the bag 12 can expand radially towards the external walls of aneurysm A while unexpanded portions (for example, segment 11) of braid 10 continue to be translated by the application tube 30. In Figure 4B, the delivery tube 30 moves distally away from the microcatheter 20 and the braid 10 begins to reverse as its end 16 continues to move distally, through the delivery tube 30, away from the microcatheter 20 towards the aneurysm A. O delivery tube 30 can be driven by a hypotube from its proximal end 36 (not shown) by an operator or the like. The microcatheter 20 can remain relatively stationary or fixed while the delivery tube 30 can be seen distally by translating the braid 10 towards and through the neck of the aneurysm A. The braid 10 can include a pre-weakened or buckling portion 17 so that braid 10 and application tube 30 are moved distally away from microcatheter 20 and to aneurysm A, segment 11 can be
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    18/24 transferred, causing radial expansion of segment 12 to form the corresponding occlusive sac. The continued distal translation of the braid 10 can also cause the braid 10 to bend and the end 16 to be inverted in the segment 12 bag. In certain embodiments, the portion 17 can initiate the inversion of the end 16 in the segment 12. The inversion of the end 16 in segment 12 is particularly advantageous since it prevents the braid 10 from creating a protuberance that would otherwise extend into the parental vessel. Instead, any bulge is now inverted and folded into segment 12. By arranging braid 10 in this way through the neck of the aneurysm, including inversion of the end 16 in the segment 12 bag, a flow deflection is created essentially inside the segment 12 bag.
    [0056] It is understood that the buckling portion 17 can be formed in the interstices of the braid 10 between the end 14 of the braid 10 and the locking portion 54 between the braid 10 and the application tube 30 so that an inversion occurs after the braid 10 has distally translated a predetermined distance out of the application tube 30. The portion 17 can simply be a weak point or pre-adjusted buckling point for a specific bag 12 so that the buckling is induced in order to avoid deformation of aneurysm A. Alternatively, no buckle portion 17 can be included, and instead, braid 10 can invert and bend itself by contacting the end 14 of the braid with the dome D of an aneurysm A (for example, based on the pre-selected elasticity of the braid 10).
    [0057] The locking portion 54 and / or portions of the application tube 30 may be at the level of the neck of aneurysm A, as seen under fluoroscopy. Moving between Figures 4A to 5B, the outer diameter of braid 10 around segment 12 expands radially
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    19/24 to a diameter larger than microcatheter 20 as the occlusive bag of segment 12 is formed. In Figure 5A, delivery system 40 can continue to be moved distally until the junction between end 16 of braid 10, locking portion 54 and delivery tube 30 are completely within the spherical occlusive bag of segment 12 and the reverse braid 10 stop. Once the braid 10, the segment 12 and the corresponding inversion of the end 16 are selectively positioned and arranged for the desired condition (for example, the braid 10 was translated distally to expand the segment 12 to form its bag and the segments were inverted in it), the braid 10 can be separated from the application tube 30, as shown in Figure 5B. The application tube 30 between Figures 4A and 5A continues to slide the braid 10 distally until, in Figure 5A, unexpanded, segments behind segment 12 (for example, segment 13, segment 11, or any other segments behind the segment 12 not shown) invert and be folded into the segment 12 bag. In other words, as the braid 10 is distally translated towards the dome of aneurysm A, the braid 10 segments that are proximal to the segment 12 can be used to force the inversion like a tube sock. In turn, the application tube 30 can be moved proximally into the microcatheter 20 and collected from the braid 10 and aneurysm A.
    [0058] The count of interstices of braid wire 10 that can form the outer surface of your expandable and invertible net may vary depending on the diameter of the segment 12 bag and / or any inverted bags inside it. For example, to induce the formation of the predetermined shape and strength of the occlusive bag of segment 12, the end 14 of the braid 10 may be more malleable than the other end 16, or vice versa, and other segments of braid 10, including the segments 11, 12 and 13, can vary from more
    Petition 870190015044, of 02/14/2019, p. 22/46
    20/24 malleable at or over the end 14 and less malleable at or over the end 16. The interstices of the braid 10 can also form openings for occlusion of the aneurysm.
    [0059] In Figure 5B, an exemplary spherical segment bag 12 fully formed in a manner sufficient to occlude aneurysm A with one or more inverted portions disposed internal to the segment bag 12, the braid 10 can be separated from the locking portion 54 However, if the segment 12 bag is not precisely positioned or if the segment 12 and / or any internally arranged segments formed by inversion of segments proximal to them need to be reset or adjusted within aneurysm A for safe occlusion without risk of rupture, braid 10, including segment 12, can be retracted back into application tube 30 by proximally withdrawing application tube 30 back into microcatheter 20 while still attached to braid 10. In Figure 5B, a Since the segment 12 bag was selectively positioned and formed within aneurysm A, the braid 10 was separated from the application tube 30 and the tube d and application 30 and microcatheter 20 can now be retrieved from aneurysm A and the lesion site. It is understood that part or all of the locking portion 54 can be formed with the microcatheter 20 or the delivery tube 30 and / or can be radiopaque so that positioning and separation can be monitored and / or triggered under fluoroscopy.
    [0060] Figures 6A to 7B generally illustrate the exemplary fixation and application between the application tube 30 and the braid 10 for implantation and separation of the braid 10 in the aneurysm A. The modalities of Figures 6A to 7B are merely a way that the tube of application 30 and the braid 10 can be fixed at the end 34 and any number of fixing means is contemplated as necessary or required. Application tube 30, as shown, may have a lumen
    Petition 870190015044, of 02/14/2019, p. 23/46
    21/24 extending from a proximal end 36 to a distal application end 34. Figure 6A illustrates braid 10 engaged with locking member 52 and loop wire 58 locked in locking portion 54. The opening 60 of the loop wire 58 can be placed through the locking portion 54. The locking portion 54 preferably takes the form of a small diameter elongated filament, however, other shapes such as wire or tubular structures are also suitable. Although the locking portion 54 is preferably formed of nitinol, other metals and materials such as stainless steel, PTFE, nylon, ceramic or fiberglass and composites may also be suitable. The locking member 52, in one example, can be an elongated retractable fiber that can extend between the ends 24 and 26 of the microcatheter 20. The locking member 52 preferably takes the form of a small diameter elongated filament, however, other shapes such as wires or tubular structures are also suitable. Although locking member 52 is preferably formed of nitinol, other metals and materials such as stainless steel, PTFE, nylon, ceramic or fiberglass and composites may also be suitable. When the locking member 52 is placed through the opening 60, the braid 10 is now secured. It is understood that the delivery tube 30 can include a compressible portion 38 disposed between its ends 34 and 36.
    [0061] The compressible portion 38 may allow the delivery tube 30 to bend and / or flex. Such flexibility can help to trace the braid 10 through the microcatheter 20 and the tortuous trajectory through the vasculature. The compressible portion 38 can be formed with interference spiral cuts which can allow for bends to allow bending, but, in one example, do not act as a spiral cutting spring. The compressible portion 38 can be axially adjustable between an elongated condition and a compressed condition. However, any other
    Petition 870190015044, of 02/14/2019, p. 24/46
    22/24 arrangement that allows axial adjustment (for example, a coiled wire or spiral ribbon) may also be suitable for use with separation systems according to the present invention). The compressible portion 38 can be in the stretched condition at rest and automatically or resiliently returns to the stretched condition from a compressed condition, unless otherwise specified. The function of the compressible portion 38 is described in more detail in this document.
    [0062] In Figure 6A, a force F was previously applied to place the application tube 30 in a compressed state. Figure 6B illustrates locking member 52 being pulled proximally to initiate the release sequence for braid 10. Figure 7A illustrates the instant when locking member 52 exits opening 60 and is pulled free from loop wire 58. The distal end 62 of the loop wire 58 falls / returns to its preformed shape and exits the locking portion 54. As can be seen, there is now nothing to attach the braid 10 to the application tube 30. Figure 7B illustrates the end of the release sequence. Here, the compressible portion 38 of the delivery tube 30 has expanded / returned to its original shape and pushed forward. An elastic force E is provided by the distal end 34 of the application tube 30 for the braid 10 to push it in the opposite direction to ensure a clean separation and application of the braid 10 to the aneurysm A. It should be understood that the application scheme described in the Figures 6A to 7B are merely exemplary approaches for applying the braid 10.
    [0063] Figure 8 is a flow diagram for an 800 method of applying an occlusive device. Step 805 includes positioning an occlusive device within a microcatheter and in communication with an application tube, wherein the occlusive device includes a braid capable of expanding and reversing itself. Step 810 includes sliding the microcatheter braid distally through the application tube. The stage
    Petition 870190015044, of 02/14/2019, p. 25/46
    23/24
    815 includes expanding radially as the braid extends distally from the microcatheter, a distal segment of the braid between the proximal and distal ends of the braid to form an occlusive sac within the aneurysm. Step 820 includes reversing the proximal end of the braid in the occlusive bag. Step 825 includes separating the application tube braid and removing the application tube from the aneurysm.
    [0064] Figure 9 is a flow diagram for a method 900 of applying an occlusive device. Step 905 includes sliding an application tube into a microcatheter. Step 910 includes slidingly placing a braid with the application tube, where the braid is in a retracted state and comprises a distal end and a proximal end. This step may also include removably attaching the proximal end of the braid to the distal end of the delivery tube. Step 915 includes selectively positioning the microcatheter, the delivery tube and the braid in the aneurysm vasculature. Step 920 includes sliding the braid distally through the application tube of the microcatheter towards the aneurysm. Step 925 includes causing a distal segment between the proximal and distal ends of the braid to move from the retracted state within the microcatheter to an implanted state defined by the distal segment expanding radially to form an occlusive sac as the distal end of the braid is moved distally from the microcatheter. Step 930 includes inverting and / or folding a proximal segment into the occlusive bag. Step 935 includes releasing the braid into the aneurysm and removing the delivery tube and microcatheter from the aneurysm and vasculature.
    [0065] It is understood that variations of braid 10 can include various materials such as nitinol, stainless steel, bioabsorbable materials and polymers. Braid 10, including any specific portions like
    Petition 870190015044, of 02/14/2019, p. 26/46
    24/24 any breaks and corresponding bags, can be adjusted by heat for various configurations, such as spherical, oblong, saddle-shaped, etc. with the purpose of formatting the initial sac to better match the morphology of the aneurysm. In addition, the braid 10 can be thermally shaped to include weak points to facilitate buckling of the braid when it reaches the aneurysm dome. It is also understood that any bag formed by the braids 10 discussed herein can have a spherical shape as shown or any other shape, as needed or required, such as ellipsoidal, heart-shaped, ovoid, cylindrical, hemispherical or the like. Additionally, the interstices of the braid 10 that form the bag can vary, or be selectively designed, in size or shape along its length, depending on how much of the braid 10 is caused to expand radially as the application tube 30 is moved distally. . [0066] The specific configurations, the choice of materials and the size and shape of various elements may vary according to the specifications or restrictions of a specific design that require a system or method built according to the principles of the revealed technology. Such modifications are intended to be included within the scope of the disclosed technology. Therefore, the modalities disclosed herein are considered in all respects to be illustrative and not restrictive. Therefore, it will be evident from the aforementioned that, although specific forms of the description have been illustrated and described, several modifications can be made without deviating from the character and scope of the description, and all changes understood in the meaning and scope of their equivalents are designed to be included in them.
    权利要求:
    Claims (20)
    [1]
    1. Occlusive device for the treatment of an aneurysm, characterized by the fact that it comprises:
    an application system; and a braid that is slidably disposed within the microcatheter in a retracted state, wherein the braid has a distal end opposite to a proximal end, where the braid comprises a distal segment between the distal and proximal ends;
    wherein the braid is translatable distally from inside the microcatheter to an implanted state;
    where the braid expands radially to the implanted state as the distal end of the braid exits the microcatheter, causing the distal segment to form an occlusive sac for the aneurysm.
    [2]
    2. Device, according to claim 1, characterized by the fact that the distal segment is able to be disposed through the neck of the aneurysm, in which the distal segment comprises a reduced porosity in relation to the occlusive sac, thus inducing an effect of flow deviation or reduced flow velocity in the aneurysm.
    [3]
    3. Device, according to claim 1, characterized by the fact that the distal segment is able to be disposed through the neck of the aneurysm, in which the distal segment comprises a higher braiding angle in relation to the occlusive sac.
    [4]
    4. Device according to claim 1, characterized by the fact that moving the braid distally after or as the occlusive bag is formed causes the proximal end of the braid to reverse and one or more segments proximal to the distal segment to bend inward of the occlusive bag.
    Petition 870190015044, of 02/14/2019, p. 28/46
    2/5
    [5]
    5. Device according to claim 4, characterized by the fact that the one or more segments proximal to the distal segment have a braid angle increased in relation to a braid angle of the distal segment to facilitate inversion.
    [6]
    6. Device according to claim 1, characterized by the fact that the distal end of the braid is open.
    [7]
    7. Device, according to claim 1, characterized by the fact that, in the implanted state, the braid is removable from the application system in the aneurysm, in which the application system comprises:
    an application tube comprising a distal end and a proximal end, where the distal end of the application tube is removably connected to the proximal end of the braid, where the application tube is available translatably within a microcatheter;
    wherein the application tube moves the braid distally inside the microcatheter from the retracted state to the implanted state.
    [8]
    8. Device according to claim 7, characterized by the fact that the braid additionally comprises:
    a tapered segment disposed between the distal segment and a proximal segment, where the proximal segment is disposed on or adjacent to the proximal end of the braid;
    where the occlusive bag of the distal segment is spherical and is able to seal the neck of the aneurysm.
    [9]
    9. Device according to claim 8, characterized by the fact that the distal segment expands to form the occlusive bag as the distal end of the braid is distally translated away from the application tube.
    [10]
    10. Device according to claim 8, characterized by the fact that the proximal segment fixes the braid to the end
    Petition 870190015044, of 02/14/2019, p. 29/46
    3/5 distal of the application tube and, after the distal segment has expanded to form the occlusive sac, the inversion of the proximal end of the braid superimposed on the occlusive sac of the distal segment begins.
    [11]
    11. Device according to claim 8, characterized by the fact that the occlusive bag of the distal segment is a retractable cage-type vessel-occlusive structure.
    [12]
    12. Device according to claim 8, characterized by the fact that the distal segment comprises fewer segments of wire than the tapered and proximal segments.
    [13]
    13. Device according to claim 8, characterized by the fact that the tapered segment diverts the flow as the distal segment forms the adjacent occlusive sac or is against an aneurysm wall and the proximal segment is inverted in the distal segment in the neck of the aneurysm.
    [14]
    14. Device according to claim 7, characterized in that the braid additionally comprises a portion of buckling defined between the distal segment and the tapered and / or proximal segments.
    [15]
    15. Device according to claim 14, characterized by the fact that the proximal end of the overlapping braid internal to the occlusive bag of the distal segment is formed by inversion in the buckling portion, as the braid continues to move distally from the microcatheter and after the occlusive bag of the distal segment has been formed by the radial expansion.
    [16]
    16. Device according to claim 1, characterized by the fact that it additionally comprises:
    an imaging device in communication with the occlusive device, in which the imaging device is capable of imaging the sac in relation to the aneurysm; and where an orientation of the occlusive bag is adjustable by
    Petition 870190015044, of 02/14/2019, p. 30/46
    4/5 braid being distal or proximally moved.
    [17]
    17. Braid to treat an aneurysm, where the braid is characterized by the fact that it comprises:
    a distal segment defined between the proximal and distal ends of the braid; and a tapered segment disposed between the distal segment and a proximal segment, wherein the proximal segment is disposed on or adjacent to the proximal end;
    wherein the braid is able to move from a retracted state within a microcatheter to an implanted state external to the microcatheter;
    in which the translation of the braid so that the distal end is distal to the microcatheter causes the distal segment to expand radially and form an external occlusive sac, in which the occlusive sac has a larger diameter than the microcatheter;
    wherein the translation of the braid distally after the external occlusive sac has been formed causes the proximal end of the braid to reverse into the occlusive sac.
    [18]
    18. Braid according to claim 17, characterized by the fact that the lumen additionally comprises a buckling portion disposed between the distal segment and tapered and / or proximal segments, wherein the buckling portion causes the proximal end of the reverse braid into the occlusive bag.
    [19]
    19. Braid according to claim 17, characterized by the fact that a braid angle of the tapered segment is reduced compared to a braid angle of the distal segment.
    [20]
    20. Method for applying an occlusive device to an aneurysm in a blood vessel in a patient, characterized by the fact that it comprises:
    Petition 870190015044, of 02/14/2019, p. 31/46
    5/5 slide an application tube into a microcatheter;
    slidingly position a braid with the application tube, where the braid is in a retracted state and comprises a distal end and a proximal end;
    selectively position the microcatheter, the delivery tube and the braid in the vasculature of the aneurysm;
    slide the braid distally through the application tube of the microcatheter towards the aneurysm;
    cause a distal segment between the proximal and distal ends of the braid to move from the retracted state within the microcatheter to an implanted state defined by the distal segment expanding radially to form an occlusive sac as the distal end of the braid is moved distally from the microcatheter ;
    invert a proximal segment close to the distal segment in the occlusive sac; and release the braid inside the aneurysm and remove the application tube and microcatheter from the aneurysm.
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    公开号 | 公开日
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    RU2018145543A|2020-06-22|
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    AU2018282472A1|2019-07-11|
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    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US6168622B1|1996-01-24|2001-01-02|Microvena Corporation|Method and apparatus for occluding aneurysms|
    US7410482B2|1998-09-04|2008-08-12|Boston Scientific-Scimed, Inc.|Detachable aneurysm neck bridge|
    US6391037B1|2000-03-02|2002-05-21|Prodesco, Inc.|Bag for use in the intravascular treatment of saccular aneurysms|
    US20030195553A1|2002-04-12|2003-10-16|Scimed Life Systems, Inc.|System and method for retaining vaso-occlusive devices within an aneurysm|
    US20040044391A1|2002-08-29|2004-03-04|Stephen Porter|Device for closure of a vascular defect and method of treating the same|
    US8777974B2|2004-03-19|2014-07-15|Aga Medical Corporation|Multi-layer braided structures for occluding vascular defects|
    BE1016067A3|2004-06-03|2006-02-07|Frid Noureddine|Luminal endoprosthesis FOR OBSTRUCTION OF ANEURYSM AND METHOD OF MANUFACTURING SUCH STENT.|
    CA2595809A1|2004-08-31|2006-03-09|Cook Incorporated|Device for treating an aneurysm|
    AU2005305367A1|2004-09-22|2006-05-18|Lee R. Guterman|Cranial aneurysm treatment arrangement|
    JP2008519613A|2004-11-09|2008-06-12|ボストン サイエンティフィック リミテッド|Vascular occlusion device with composite shaped proximal portion and smaller diameter distal|
    US20080281350A1|2006-12-13|2008-11-13|Biomerix Corporation|Aneurysm Occlusion Devices|
    US9232992B2|2008-07-24|2016-01-12|Aga Medical Corporation|Multi-layered medical device for treating a target site and associated method|
    US8758423B2|2009-06-18|2014-06-24|Graftcraft I Goteborg Ab|Device and method for treating ruptured aneurysms|
    US20110152993A1|2009-11-05|2011-06-23|Sequent Medical Inc.|Multiple layer filamentary devices or treatment of vascular defects|
    JP6087281B2|2010-09-10|2017-03-01|メディナ メディカル，インコーポレイテッド|Device and method for treating vascular abnormalities|
    US8998947B2|2010-09-18|2015-04-07|Medina Medical, Inc.|Devices and methods for the treatment of vascular defects|
    US20120283768A1|2011-05-05|2012-11-08|Sequent Medical Inc.|Method and apparatus for the treatment of large and giant vascular defects|
    US8993831B2|2011-11-01|2015-03-31|Arsenal Medical, Inc.|Foam and delivery system for treatment of postpartum hemorrhage|
    US20130204351A1|2012-02-02|2013-08-08|Inceptus Medical LLC|Aneurysm Graft Devices And Methods|
    US20140135811A1|2012-11-13|2014-05-15|Covidien Lp|Occlusive devices|
    US10342546B2|2013-01-14|2019-07-09|Microvention, Inc.|Occlusive device|
    WO2014144980A1|2013-03-15|2014-09-18|Covidien Lp|Occlusive device|
    US9314324B2|2013-07-29|2016-04-19|Insera Therapeutics, Inc.|Vascular treatment devices and methods|
    US9955976B2|2013-08-16|2018-05-01|Sequent Medical, Inc.|Filamentary devices for treatment of vascular defects|
    US11154302B2|2014-03-31|2021-10-26|DePuy Synthes Products, Inc.|Aneurysm occlusion device|
    WO2015160721A1|2014-04-14|2015-10-22|Sequent Medical Inc.|Devices for therapeutic vascular procedures|
    BR102014014407A2|2014-06-12|2016-04-19|Biocelere Agroindustrial Ltda|expression cassette to transform eukaryotic cell, genetically modified micro-organism with efficient xylose consumption, process for biofuel and biochemical production and biofuel and / or biochemical thus produced|
    CN204683687U|2015-04-15|2015-10-07|中国人民解放军第二军医大学|A kind of intracranial aneurysm neck reconstructing device|
    AU2017218115B2|2016-02-10|2020-03-05|Microvention, Inc.|Devices for vascular occlusion|
    US10751066B2|2017-02-23|2020-08-25|DePuy Synthes Products, Inc.|Aneurysm device and delivery system|US11076860B2|2014-03-31|2021-08-03|DePuy Synthes Products, Inc.|Aneurysm occlusion device|
    US11154302B2|2014-03-31|2021-10-26|DePuy Synthes Products, Inc.|Aneurysm occlusion device|
    CA2976260A1|2015-02-25|2016-09-01|Galaxy Therapeutics, Llc|System for and method of treating aneurysms|
    US10751066B2|2017-02-23|2020-08-25|DePuy Synthes Products, Inc.|Aneurysm device and delivery system|
    US11185335B2|2018-01-19|2021-11-30|Galaxy Therapeutics Inc.|System for and method of treating aneurysms|
    US10905430B2|2018-01-24|2021-02-02|DePuy Synthes Products, Inc.|Aneurysm device and delivery system|
    US11058430B2|2018-05-25|2021-07-13|DePuy Synthes Products, Inc.|Aneurysm device and delivery system|
    US10939915B2|2018-05-31|2021-03-09|DePuy Synthes Products, Inc.|Aneurysm device and delivery system|
    US11123077B2|2018-09-25|2021-09-21|DePuy Synthes Products, Inc.|Intrasaccular device positioning and deployment system|
    US11076861B2|2018-10-12|2021-08-03|DePuy Synthes Products, Inc.|Folded aneurysm treatment device and delivery method|
    US11134953B2|2019-02-06|2021-10-05|DePuy Synthes Products, Inc.|Adhesive cover occluding device for aneurysm treatment|
    US11202636B2|2019-05-25|2021-12-21|Galaxy Therapeutics Inc.|Systems and methods for treating aneurysms|
    US20210169495A1|2019-12-05|2021-06-10|DePuy Synthes Products, Inc.|Intrasaccular inverting braid with highly flexible fill material|
    法律状态:
    2019-07-02| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US15/852,887|US10716574B2|2017-12-22|2017-12-22|Aneurysm device and delivery method|
    US15/852,887|2017-12-22|
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