Patent Grant
11890020
The present invention generally relates to medical instruments, and more particularly, to embolic implants for aneurysm therapy.
Cranial aneurysms can be complicated and difficult to treat due to their proximity to critical brain tissues. Prior solutions have included endovascular treatment whereby an internal volume of the aneurysm sac is removed or excluded from arterial blood pressure and flow. Current alternatives to endovascular or other surgical approaches can include intravascularly delivered treatment devices that fill the sac of the aneurysm with embolic material and/or block the entrance or neck of the aneurysm. Such approaches attempt to prevent blood flow into the aneurysm and promote formation of a thrombotic mass within the aneurysm.
Intravascularly delivered aneurysm treatment devices can typically be anchored in place within the aneurysm sac, within the blood vessel, or both. Intrasaccular aneurysm treatment devices, such as embolic coils, are anchored in place primarily within the aneurysm sac. Alternatives to embolic coils are being explored, for example a tubular braided implant is disclosed in US Patent Publication Number 2018/0242979, incorporated herein by reference.
Intrasaccular aneurysm treatment devices can typically include embolic material to promote formation of thrombotic mass within the aneurysm. Care must be taken when placing the intrasaccular devices so that embolic material and/or a clot formed thereon does not impede the flow of blood in the adjoining parent blood vessel, which can occur if the entrance to the aneurysm is overpacked. Conversely, if the entrance and/or sac is insufficiently packed, blood flow can persist into the aneurysm. Certain aneurysm morphology (e.g. wide neck, bifurcation, etc.) can be particularly challenging to treat, and current treatments of such morphology commonly rely on ancillary devices such a stents or flow diverters positioned within the adjoining blood vessel to cover the aneurysm entrance, protecting the adjoining blood vessel from becoming obstructed and retaining the intrasaccular device within the aneurysm. Placement of ancillary devices can be non-ideal as it can generally increase treatment time and complexity of the treatment procedure compared to treatments that can be performed without ancillary devices.
There is therefore a need for improved methods, implants, and systems for aneurysm treatment.
It is an object of the present invention to provide systems, implants, and methods to meet the above-stated needs. Generally, it is an object of the present invention to provide an intrasaccular implant for treating an aneurysm having one or more coated regions, each coated region having a coating to either inhibit blood cell adhesion or promote blood cell adhesion. One or more regions of the implant that are designed to be implanted (and/or can potentially be implanted) in a position to contact blood from a parent blood vessel can be coated with a coating to inhibit blood cell adhesion to thereby reduce the likelihood that a thrombus can form on the implant that occludes the parent blood vessel. One or more regions of the implant that are designed to be contained within the aneurysm sac can be coated, abraded, or otherwise modified to promote blood cell adhesion to thereby promote thrombus formation within the aneurysm sac to reduce the likelihood of blood flow persisting into the aneurysm. The coatings can be applied linearly on separate lengths of a tubular braided implant. Coatings that are applied linearly on separate lengths of the tubular braid can be easier to apply compared to coatings that are applied opposite each other on an interior surface of the tubular braid and an outer surface of the tubular braid.
An example implant can include a braided mesh and two separate coatings. The braided mesh can be movable from a delivery configuration sized to traverse a catheter to an implanted configuration sized to be implanted in an aneurysm sac. The coatings can be disposed on the braided mesh, each respectively defining a section of the braided mesh, such that a section defined by one coating is separate from the section defined by the other coating. When the braid is in the implanted configuration, one of the coated sections can be positioned to occlude some or all of the aneurysm neck, and the other of the coated sections can be positioned within the aneurysm sac. The coated section positioned to occlude the aneurysm neck can be coated with an anti-thrombogenic and/or hydrophilic coating. The coated section positioned within the aneurysm sac can be coated with a cell adhesion coating.
The braided mesh can have, be movable to, and/or be constructed from a tubular shape having a single layer. The coated sections can be disposed along separate lengths of the braided mesh when the mesh is in the single-layer tubular shape. The coated sections can be non-overlapping.
The implant can also have one or more uncoated sections. An uncoated section can be positioned between the two coated sections.
When the braided mesh is in the implanted configuration, the coated section positioned to occlude the aneurysm neck can be positioned to form a barrier between the other coated section and a parent blood vessel.
When the braided mesh is in the implanted configuration, the coated section positioned for placement in the aneurysm sac can be shaped to form a sack within the aneurysm sac.
When the braided mesh is in the implanted configuration, the coated section positioned to occlude the aneurysm neck can also be positioned to contact the wall of the aneurysm, and the other coated section can be positioned to press the aforementioned coated section against the aneurysm wall.
An example method for designing, constructing, and/or configuring an implant for aneurysm treatment can include one or more of the following steps presented in no particular order, and the method can include additional steps not included here. A braided mesh can be selected. The selected braided mesh can be shaped as a tube. Two non-overlapping sections of the braided mesh can be respectively coated. When the braided mesh is shaped as a tube, the two coated sections can define two, separate, non-overlapping lengths along the axis of the tube. One of the sections can be coated with an anti-thrombogenic coating and the other section can be coated with a cell adhesion coating. The braided mesh can be shaped into a predetermined shape sized to be placed within an aneurysm sac. When in the predetermined shape, one of the sections can be shaped to extend across an aneurysm neck, contact an aneurysm wall, and at least partially surround the other section. The braided mesh can be collapsed to a delivery configuration sized to traverse a catheter positioned within vasculature.
An example method for treating an aneurysm can include one or more of the following steps presented in no particular order, and the method can include additional steps not included here. An implant having a braided mesh can be selected such that one portion of the braided mesh has an anti-thrombogenic coating and another portion has a cell adhesion coating. The braided mesh can be collapsed to a delivery configuration sized to traverse a catheter to the aneurysm. The braided mesh can be positioned within the catheter such that the anti-thrombogenic coated portion is positioned distally in relation to the blood cell adhesion coated portion. Alternatively, the braided mesh can be positioned within the catheter such that the anti-thrombogenic coated portion is positioned proximally in relation to the blood cell adhesion coated portion. In addition to either delivery configuration, or as an alternative delivery configuration, the braided mesh can be positioned within the catheter such that the anti-thrombogenic coated portion at least partially surrounds the cell adhesion coated portion.
The portion of the braided mesh with the anti-thrombogenic coating can be positioned to occlude the aneurysm's neck. The portion of the braided mesh with the cell adhesion coating can be placed within the aneurysm's sac. The portion of the braided mesh with the anti-thrombogenic coating can be positioned to obstruct communication between a parent blood vessel of the aneurysm and the blood cell adhesion coating. The portion of the braided mesh coated with the anti-thrombogenic coating can be positioned to extend beyond a plane defined by the aneurysm's neck. The portion of the braided mesh having the blood cell adhesion coating can form a sack within the aneurysm sac. Additionally, or alternatively, the braided mesh having the blood cell adhesion coating can loop within the aneurysm sac.
The portion of the braided mesh coated with the anti-thrombogenic coating can be positioned to contact the aneurysm's wall. The portion of the braided mesh coated with the cell adhesion coating can be positioned to press the first portion of the braided mesh to the aneurysm's wall.
Blood clotting within the parent blood vessel near the aneurysm's neck can be inhibited by the portion of the braided mesh coated with the anti-thrombogenic coating. Thrombosis can be induced within the aneurysm's sac with the portion of the braided mesh coated with the cell adhesion coating.
Blood flow through a rupture in the aneurysm's wall can be inhibited by the implant.
The above and further aspects of this invention are further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation.
In known treatments of wide neck aneurysms, the aneurysm is typically treated by placing embolic coils within the aneurysm sac and placing a stent within the parent blood vessel across the aneurysm neck. The stent is necessary in many cases to inhibit the embolic coils from entering the parent blood vessel. If embolic coils enter the parent blood vessel, the coils can obstruct the vessel and/or clots can form on the coils within the blood vessel and create an obstruction in the parent blood vessel. Braided aneurysm intrasaccular implants can be used to treat wide neck aneurysms without requiring a stent to secure the braided implant at the aneurysm neck. In some treatments, to provide a secure seal to block blood flow into the aneurysm neck, it can be desirable to position a portion of the braided intrasaccular implant to partially protrude into the parent blood vessel. However, for braid material having cell adhesion properties, clots can potentially form on the protruded portion within the parent vessel and obstruct the parent blood vessel. Braided aneurysm intrasaccular implants, in some cases, rely on less embolic mass within the aneurysm sac compared to embolic coils, and in those cases, blood stasis may not occur as quickly within the aneurysm sac compared to a treatment wherein the aneurysm sac is densely packed with embolic coils.
Aspects of the present invention are directed to address the above challenges. In examples presented herein, a braided aneurysm implant can be coated with an anti-thrombogenic coating (such as a hydrophilic coating), a cell adhesion coating, or both. The braid of the implant can be formed from a generally tubular, single layer, linear weave. When used herein, the terms “tubular” and “tube” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length. For example, the tubular structure or system is generally illustrated as a substantially right cylindrical structure. However, the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.
Each coating can be disposed on a linear section of the braid. The braid can have a predetermined shape that is shaped to treat a predetermined range of aneurysm sizes, a delivery shape sized to traverse a lumen of a catheter to an aneurysm, and an implanted shape that is based on the predetermined shape and the shape of the sac and neck of the aneurysm.
When in the implanted shape, a portion of the braid can occlude the neck of the aneurysm, and this portion can be coated with the anti-thrombogenic coating. Implanted this way, if the braid protrudes into the parent vessel, the anti-thrombogenic coating can be effective to prevent thrombus from forming on the protruding braid portion and thereby preventing occlusion of the parent blood vessel by such a thrombus formation. Additionally, or alternatively, a portion of the braid contained within the aneurysm sac can be coated with a cell adhesion coating. The cell adhesion coating can be effective to promote thrombus formation within the aneurysm sac. In some treatments, a portion of the braid having cell adhesion coating thereon can be placed across a rupture in the aneurysm's wall, and the cell adhesion coated braid portion can be effective to inhibit and ultimately eliminate blood flow out of the sac through the rupture.
Turning to the figures,
Coatings can be applied by dipping, spraying, or other means as would be appreciated and understood by a person of ordinary skill in the art. Abrading can be applied in place of, or in addition to a cell adhesion coating in sections 162, 262, 362, 462, 562, 662, 762, 862, 962, 1062, 1162 with enhanced cell adhesion properties. For ease of discussion, sections with enhanced cell adhesion properties are described herein as “coated”, however, it is to be understood that abrading or otherwise enhancing the cell adhesion properties can be used in addition to, or in place of coating.
A coating (or other surface enhancement) can be applied to only one side of the braid (e.g. either within the lumen of a tubular braid or on the outer surface of the tubular braid), or a coating can be applied to both sides of the braid. In some examples, one coating can be applied to one side of the braid and a second coating can be applied to the other side of the braid. In some examples, two coatings can be applied to the same side of the braid. In some examples, one coating can be applied to both sides of the braid and a second coating can be applied to only one side of the braid. In some examples, two coatings can each be applied to both sides of the braid.
Examples presented herein primarily illustrate two coated regions, however, the braid can be coated or abraded, or otherwise enhanced in multiple lengths according to aspects of the present disclosure.
In the examples illustrated, each braided mesh 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110 can have a delivery shape that is sized to traverse a lumen of a catheter 20 to an aneurysm 10, 10a, 10b and an implanted shape that is sized to be implanted in the aneurysm sac 12, 12a, 12b. Each braided mesh 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110 can also have a predetermined shape that is shaped to treat a predetermined range of aneurysm sizes. When the implant 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100 exits the catheter 20 and enters the aneurysm 10, 10a, 10b, the braid 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110 can move toward the predetermined shape and be confined by the shape of the aneurysm walls 14, 14a, 14b and aneurysm neck 16, 16a, 16b such that the resulting implanted shape of the braid is based on the predetermined shape and the anatomy of the aneurysm.
In the examples illustrated, coatings can be positioned on the braided mesh 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110 such that when implanted, the section 164, 264, 364, 464, 564, 664, 764, 864, 964, 1064, 1164 coated with anti-thrombogenic coating is placed at the aneurysm neck 16, 16a, 16b and/or the section 162, 262, 362, 462, 562, 662, 762, 862, 962, 1062, 1162 coated with cell adhesion coating is confined within the aneurysm sac 12, 12a, 12b. The position of the coated section(s) when implanted can be predetermined to a large extent by virtue of the predetermined shape and the anatomy of the aneurysm 10, 10a, 10b being known. In other words, the coated section(s) 162, 262, 362, 462, 562, 662, 762, 862, 962, 1062, 164, 264, 364, 464, 564, 664, 764, 864, 964, 1064, 1164 can be positioned in relation to the predetermined shape of the braid 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110 such that when the braid is implanted, each coated section can be predictably placed either to occlude the aneurysm neck 16, 16a, 16b or to be contained within the aneurysm sac 12, 12a, 12b.
In the examples illustrated, each implant 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100 can be formed from a generally tubular, single-layer braided mesh 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110. Each tubular braid 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110 can respectively have a first end 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 and a second end 114, 214, 314, 414, 514, 614, 714, 814, 914, 1014, 1114. The coatings can be applied in two separate linear sections 162, 262, 362, 462, 562, 662, 762, 862, 962, 1062, 164, 264, 364, 464, 564, 664, 764, 864, 964, 1064, 1164 of the braided mesh between the two ends of the braided mesh.
In some of the illustrated examples, some implants 100, 200, 400, 500, 700, 800, 900, 1100 can include an uncoated section 166, 266, 466, 566, 766, 866, 966, 1166 between the two coated sections 162, 262, 462, 562, 762, 862, 962, 164, 264, 464, 564, 764, 864, 964, 1164. The section 162, 262, 462, 562, 662, 762, 862, 962, 1162 of each braided mesh 110, 210, 410, 510, 610, 710, 810, 910, 1110 coated with cell adhesion coating can have enhanced cell adhesion properties compared to the uncoated section 166, 266, 466, 566, 766, 866, 966, 1166 of that braided mesh. The section 164, 264, 464, 564, 664, 764, 864, 964, 1164 of each braided mesh coated with anti-thrombogenic coating can have inhibited cell adhesion properties compared to the uncoated section 166, 266, 466, 566, 766, 866, 966, 1166 of that braided mesh. In some applications it can be advantageous to position an uncoated section on a portion of the braid that can be positioned to be in communication with the parent blood vessel or positioned within the aneurysm sac depending on the aneurysm morphology and the positioning of the braid within the aneurysm. In some applications it can be advantageous to include an uncoated section to define a boundary between two coated sections so that the two coated sections are non-overlapping.
In some applications, a portion of the section 164, 264, 364, 464, 564, 646, 764, 864, 964, 1064, 1164 coated with anti-thrombogenic coating be purposefully or unintentionally positioned to extend to a proximal side of a plane 18 defining a boundary between an aneurysm 10, 10a, 10b and a parent blood vessel BV as illustrated in
Implants 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100 presented herein, in some applications, can be effective to inhibit blood flow circulation in the aneurysm. By inhibiting blood flow circulation, the implant can be effective to inhibit blood flow through a rupture in the aneurysm, particularly for ruptures near the distal portion 15, 15a, 15b, thereby promoting healing of the rupture and inhibiting blood flow through the rupture.
In the examples illustrated, each implant 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100 can include a locking portion/detachment feature 50 that can be engaged to a delivery system (not illustrated) to facilitate delivery of the implant through the catheter 20 to the aneurysm 10, 10a, 10b. The locking portion/detachment feature 50 can be disengaged from the delivery system when the implant is positioned within the aneurysm 10, 10a, 10b to allow the delivery system to be extracted. A delivery system suitable for delivering the example implants illustrated herein is disclosed in U.S. patent application Ser. No. 15/964,857 incorporated herein by reference. As would be appreciated and understood by a person of ordinary skill in the art, many other alternative delivery systems can be suitable for delivering example implants disclosed herein.
In the examples illustrated, each shape illustrated can be substantially radially symmetrical. Shapes are illustrated in profile unless otherwise stated. Some shapes are illustrated in cross-section. Examples are illustrated with portions of and aneurysm 10, 10a, 10b or a catheter 20 cut away or in cross-section.
As illustrated in
In the predetermined shape, the section 164 coated with anti-thrombogenic coating can extend across the proximal inversion 122 and include some or all of the outer segment 142 and a first portion of the middle segment 144. The uncoated section 166 can extend across the constriction 126 and include a second portion of the middle segment 144. The section 162 coated with cell adhesion coating can extend across the distal inversion 124 and can include a third portion of the middle segment 144 and some or all of the inner segment 146.
As illustrated in
As illustrated in
In either implanted shape, the section 164 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16a, 16b. The section 164 coated with anti-thrombogenic coating can form a barrier between the section 162 coated with cell adhesion coating and a parent blood vessel BV. The section 164 coated with anti-thrombogenic coating can extend to a proximal side of a plane 18 defining a boundary between the aneurysm 10a, 10b and the parent blood vessel BV. The section 164 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16a, 16b. A portion of the section 164 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14a, 14b. The anti-thrombogenic coating can be disposed on a side of the braid 110 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14a, 14b.
In either implanted shape, the section 162 coated with cell adhesion coating can be contained within the aneurysm sac 12a, 12b. The section 162 coated with cell adhesion coating can press the section 164 coated with anti-thrombogenic coating to the aneurysm wall 14a, 14b. The section 162 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12a, 12b. The cell adhesion coating can be disposed on a side of the braid 110 that is interior to the sack formed by the middle segment 144a illustrated in
In treatments wherein the aneurysm 10a has a rupture near a distal portion 15a of the aneurysm wall 14a, a portion of the section 162 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. In the implanted shape illustrated in
In either implanted shape, the uncoated section 166 can be positioned near the center of the aneurysm neck 16a, 16b.
As illustrated in
In the predetermined shape, the section 264 coated with anti-thrombogenic coating can extend across the proximal inversion 222 and include some or all of the outer segment 242 and a first portion of the middle segment 244. The uncoated section 266 can extend across the constriction 226 and include a second portion of the middle segment 244. The section 262 coated with cell adhesion coating can extend across the distal inversion 224 and can include a third portion of the middle segment 244 and some or all of the inner segment 246.
As illustrated in
As illustrated in
In the implanted shape, the section 264 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 264 coated with anti-thrombogenic coating can form a barrier between the section 262 coated with cell adhesion coating and a parent blood vessel BV. The section 264 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 264 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 210 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 262 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 262 coated with cell adhesion coating can press the section 264 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 262 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 210 that is interior to the sack formed by the middle segment 244a and on an outer surface of the compaction resistant post 248a.
In treatments in which the aneurysm 10 has a rupture near a distal portion 15 of the aneurysm wall 14, a portion of the section 262 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. The implant 200 can thereby be effective to inhibit blood flow through such a rupture.
In the implanted shape, the uncoated section 266 can be positioned near the center of the aneurysm neck 16.
As illustrated in
In the predetermined shape, the section 364 coated with anti-thrombogenic coating can extend across the proximal inversion 322 and include some or all of the outer segment 342 and a first portion of the middle segment 344. The section 362 coated with cell adhesion coating can extend across the distal inversion 324 and can include a second portion of the middle segment 344 and some or all of the inner segment 346.
As illustrated in
As illustrated in
In the implanted shape, the section 364 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 364 coated with anti-thrombogenic coating can form a barrier between the section 362 coated with cell adhesion coating and a parent blood vessel BV. The section 364 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 364 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 310 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 362 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 362 coated with cell adhesion coating can press the section 264 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 362 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 310 that is interior to the sack formed by the middle segment 344a.
In treatments in which the aneurysm 10 has a rupture near a distal portion 15 of the aneurysm wall 14, a portion of the section 362 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. The implant 300 can thereby be effective to inhibit blood flow through such a rupture.
As illustrated in
In the predetermined shape, the section 464 coated with anti-thrombogenic coating can extend across the proximal inversion 422 and include some or all of the outer segment 442 and a first portion of the middle segment 444. The uncoated section 466 can extend across the constriction 426 and include a second portion of the middle segment 444. The section 462 coated with cell adhesion coating can extend across the distal inversion 424 and can include a third portion of the middle segment 444 and some or all of the inner segment 446.
As illustrated in
As illustrated in
In the implanted shape, the section 464 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 464 coated with anti-thrombogenic coating can form a barrier between the section 462 coated with cell adhesion coating and a parent blood vessel BV. The section 464 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 464 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 410 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 462 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 462 coated with cell adhesion coating can press the section 464 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 462 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 410 that is interior to the sack formed by the middle segment 444a and on an outer surface of the compaction resistant post 446a.
In the implanted shape, the uncoated section 466 can be positioned near the center of the aneurysm neck 16.
In treatments in which the aneurysm 10 has a rupture near a distal portion 15 of the aneurysm wall 14, a portion of the section 462 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. The implant 400 can thereby be effective to inhibit blood flow through such a rupture.
As an alternative to coating the entire portion of the braid 410 corresponding to the outer segment 442 of the braid 110 in the predetermined shape illustrated in
As illustrated in
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As illustrated in
In the implanted shape, the section 564 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 564 coated with anti-thrombogenic coating can form a barrier between the section 562 coated with cell adhesion coating and a parent blood vessel BV. The section 564 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 564 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 510 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 562 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 562 coated with cell adhesion coating can press the section 564 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 562 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 510 that is exterior to the distal sack 544a. Additionally, or alternatively, cell adhesion coating can be disposed on a surface that is interior to the distal sack 544a. Preferably, the cell adhesion coating can be disposed on the surface interior to the distal sack 544a.
In treatments in which the aneurysm 10 has a rupture near a distal portion 15 of the aneurysm wall 14, a portion of the section 562 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. The implant 500 can thereby be effective to inhibit blood flow through such a rupture.
In the implanted shape, the uncoated section 566 can be positioned centrally within the aneurysm sac 12.
The implant 600 can be constructed from a braid 610 that can be shaped into a single layer tube having a first end 614 and a second end 612. When the braid 610 is extended as such, each of the respective coated sections 662, 664 can be positioned such that they are non-overlapping, occupying separate portions of the length of the braid 610. In some examples, the band 670 can be positioned at or near a boundary between the coated sections 662, 664 or between the two coated sections 662, 664. In some examples, the band 670 can be positioned over the section 664 coated with anti-thrombogenic coating.
As illustrated in
As illustrated in
As illustrated in
In the implanted shape, the section 664 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 664 coated with anti-thrombogenic coating can form a barrier between the section 662 coated with cell adhesion coating and a parent blood vessel BV. The section 664 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 664 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 610 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 662 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 662 coated with cell adhesion coating can press the section 664 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 662 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 610 interior to the inner sack 644a.
In treatments in which the aneurysm 10 has a rupture near a distal portion 15 of the aneurysm wall 14, a portion of the section 662 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. The implant 600 can thereby be effective to inhibit blood flow through such a rupture.
As illustrated in
As illustrated in
As illustrated in
In the implanted shape, the section 764 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 764 coated with anti-thrombogenic coating can form a barrier between the section 762 coated with cell adhesion coating and a parent blood vessel BV. The section 764 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 764 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 710 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 762 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 762 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 510 that is between the central segment 744 and proximal segment 742. Additionally, or alternatively, the cell adhesion coating can be disposed on the opposite side of the braid.
In the implanted shape, the uncoated section 766 can be positioned near the center of the aneurysm neck 16.
As illustrated in
As illustrated in
As illustrated in
In the implanted shape, the section 864 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 864 coated with anti-thrombogenic coating can form a barrier between the section 862 coated with cell adhesion coating and a parent blood vessel BV. The section 864 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 864 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 810 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 862 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 862 coated with cell adhesion coating can press the section 864 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 862 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 810 that is interior to the inner sack 844a. Additionally, the cell adhesion coating can be disposed on portion of the braid and on a side of the braid 810 that is in contact with the aneurysm wall 14.
In the implanted shape, the uncoated section 866 can be positioned along a ridge defined by the fold 822a. Alternatively, the uncoated section 866 can be positioned to contact the aneurysm wall 14 and the section 864 coated with anti-thrombogenic coating can include the fold 822a. In another alternative, the implant 800 need not include an uncoated section.
As illustrated in
It is also contemplated that the implant 900 can include an embolic coil in addition to and/or in place of the elongated portion 942 illustrated in
As illustrated in
As illustrated in
As illustrated in
In the implanted shape, the section 964 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 964 coated with anti-thrombogenic coating can form a barrier between the section 962 coated with cell adhesion coating and a parent blood vessel BV. The section 964 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 964 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 910 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 962 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 962 coated with cell adhesion coating can press the section 964 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 962 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 910 that is on the outside of the looping portion 942b.
In treatments in which the aneurysm 10 has a rupture near a distal portion 15 of the aneurysm wall 14, a portion of the section 962 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. The implant 900 can thereby be effective to inhibit blood flow through such a rupture.
In the implanted shape, the uncoated section 966 can be positioned to form a band in the sack 944b and positioned to contact the aneurysm wall 14. Alternatively, the uncoated section 966 can be positioned to extend across the inversion 922b and be positioned near the distal portion 15 of the aneurysm wall 14. Alternatively, the implant 900 need not include an uncoated section.
As illustrated in
The implant 1000 can be constructed from a braid 1010 that can be shaped into a single layer tube having a first end 1014 and a second end 1012. When the braid 1010 is extended as such, each of the respective coated sections 1062, 1064 can be positioned such that they are non-overlapping, occupying separate portions of the length of the braid 1010. The band 1026 can be positioned at or near a boundary between the coated sections 1062, 1064 or between the two coated sections 1062, 1064.
It is also contemplated that the implant 1000 can include an embolic coil in addition to and/or in place of the elongated portion 1042 illustrated in
As illustrated in
As illustrated in
In the implanted shape, the section 1064 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 1064 coated with anti-thrombogenic coating can form a barrier between the section 1062 coated with cell adhesion coating and a parent blood vessel BV. The section 1064 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 1064 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 1010 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 1062 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 1062 coated with cell adhesion coating can press the section 1064 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 1062 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12. The cell adhesion coating can be disposed on a side of the braid 1010 that is on the outside of the looping portion 1042b. It is also contemplated that an embolic coil used in addition to or in place of the looping portion 1042a can press the section 1064 coated with cell adhesion coating to the aneurysm wall 14.
In treatments in which the aneurysm 10 has a rupture near a distal portion 15 of the aneurysm wall 14, a portion of the section 1062 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. The implant 1000 can thereby be effective to inhibit blood flow through such a rupture.
As illustrated in
The implant 1100 can be constructed from a braid 1110 that can be shaped into a single layer tube having a first end 1114 and a second end 1112 as illustrated in
As illustrated in
In the implanted shape, the section 1164 coated with anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm neck 16. The section 1164 coated with anti-thrombogenic coating can form a barrier between the section 1162 coated with cell adhesion coating and a parent blood vessel BV. The section 1164 coated with anti-thrombogenic coating can inhibit blood clotting within the parent blood vessel BV near the aneurysm neck 16. A portion of the section 1164 coated with anti-thrombogenic coating can be positioned to contact the aneurysm wall 14. The anti-thrombogenic coating can be disposed on a side of the braid 1110 that is in communication with the parent blood vessel BV and in contact with the aneurysm wall 14.
In the implanted shape, the section 1162 coated with cell adhesion coating can be contained within the aneurysm sac 12. The section 1162 coated with cell adhesion coating can press the section 1164 coated with anti-thrombogenic coating to the aneurysm wall 14. The section 1162 coated with cell adhesion coating can induce thrombosis within the aneurysm sac 12.
In treatments in which the aneurysm 10 has a rupture near a distal portion 15 of the aneurysm wall 14, a portion of the section 1162 with cell adhesion coating that is positioned across and/or near the rupture can be effective to form a clot over the rupture and thereby inhibit blood flow through the rupture. The implant 1100 can thereby be effective to inhibit blood flow through such a rupture.
Referring to method 1200 outlined in
In step 1220, two non-overlapping sections of the tubular braided mesh can be coated. The coating can be applied with spray coating, dip coating, or by other means described herein and/or as would be appreciated and understood by a person of ordinary skill in the art. In some examples, one or both of each respective coating can be applied to only one of an inner surface or an outer surface of the braid. In some examples, one or both of each respective coating can be applied to both an inner surface and an outer surface of the braid. In some examples, one coating can be applied to an inner surface of the braid and not an outer surface of the braid and the other coating can be applied to an outer surface of the braid and not an inner surface of the braid such that the inner surfaces and the outer surfaces are defined by the inner (intralumenal) and outer surfaces of the braid when the braid is in a single-layer, non-inverted configuration.
In step 1230, the braided mesh can be shaped into a predetermined shape sized to be placed within an aneurysm. The predetermined shape can be sized such that the implant is configured for treating a predetermined range of aneurysm sizes. The predetermined shape can be sized such that when implanted the braid conforms to an implanted shape effective to anchor within an aneurysm sac. The predetermined shape can be a predetermined shape as described herein, a variation thereof, or a predetermined shape as otherwise appreciated and understood by a person of ordinary skill in the art.
In step 1240, a delivery system locking portion/detachment feature can be attached to the braided mesh. The detachment feature can be attached to the braided mesh such that the detachment feature remains attached to the braided mesh when the implant is implanted. The detachment feature can be configured to detachably attached to a delivery system and/or otherwise be configured to engage a delivery system during delivery of the implant and disengage the delivery system once the implant is in an implanted position.
In step 1250, the braided mesh can be collapsed to fit within a catheter. The braided mesh can be collapsed to a delivery shape as described herein, variations thereof, or alternative delivery shape as would be appreciated and understood by a person of ordinary skill in the art.
Referring to method 1300 outlined in
In step 1320, the implant can be collapsed to fit within a catheter. The implant can be collapsed to a delivery shape as described herein, a variation thereof, or an alternative as would be appreciated and understood by a person of ordinary skill in the art.
In step 1330, the implant can be delivered through the catheter to the aneurysm. During delivery, the implant can be positioned within the catheter in an orientation described herein, a variation thereof, or an alternative orientation as would be appreciated and understood by a person of ordinary skill in the art.
In step 1340, a portion of the braid coated with an anti-thrombogenic coating can be positioned to occlude some or all of the aneurysm's neck.
In step 1350, a portion of the braid coated with cell adhesion coating can be positioned in the aneurysm's sac. The portion of the braid coated with cell adhesion coating can form an expanded shape such as a sack, bowl, or other expanded shape. Additionally, or alternatively, the braid coated with cell adhesion coating can loop within the aneurysm's sac. The portion of the braid coated with cell adhesion coating can be positioned to press into the aneurysm wall and anchor the implant within the aneurysm's sac.
In step 1360, the anti-thrombogenic coating can inhibit blood clotting in a parent blood vessel adjacent the aneurysm. The anti-thrombogenic coating can inhibit blood clot formation within the parent blood vessel on a portion of the braid extending within the parent blood vessel when implanted.
In step 1370, the cell adhesion coating can promote blood clotting within the aneurysm. In an implant having a rupture, the blood clotting can be effective to inhibit blood flow through the rupture.
The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the implants, including alternative braid shapes, alternative coating placements, alternative materials, alternative delivery system engagement/detachment features, alternative braid size, alternative braid porosity, alternative methods for applying a coating to a braid, additional intrasaccular implant structures such as struts or anchors, alternative braid materials, alternative surface enhancement techniques to achieve enhanced cell adhesion to the braid, alternative surface enhancement techniques to achieve enhanced anti-thrombogenic properties of the braid, etc. These modifications would be apparent to those having ordinary skill in the art to which this invention relates and are intended to be within the scope of the claims which follow.
The present application is a continuation of, and claims priority under 35 U.S.C. § 120 to, U.S. patent application Ser. No. 16/595,050, filed Oct. 7, 2019, and is a continuation-in-part of, and claims priority under 35 U.S.C. § 120 to, U.S. patent application Ser. No. 16/997,543, filed on Aug. 19, 2020, which is a continuation of U.S. patent application Ser. No. 15/903,860, filed Feb. 23, 2018, which claims the benefit of U.S. Provisional Application No. 62/462,685, filed Feb. 23, 2017. The entire contents of these applications are fully incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20210007755 A1 | Jan 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62462685 | Feb 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16595050 | Oct 2019 | US |
| Child | 16997543 | US | |
| Parent | 15903860 | Feb 2018 | US |
| Child | 16997543 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16997543 | Aug 2020 | US |
| Child | 17031709 | US |
