Devices, systems, and methods for treating aneurysms

Abstract

Disclosed herein are devices, systems, and methods for treating aneurysms. In accordance with some embodiments, the present technology includes a treatment system including a delivery shaft, a manipulation shaft slidably positioned within a lumen of the delivery shaft, and an occlusion device configured for implantation within an aneurysm. The occlusion device may include a plurality of filaments secured to each other by a curing material at a proximal end of the occlusion device. The occlusion device may include an inner layer of braided filaments and an outer layer, where a proximal end region of the inner layer has an exposed portion extending proximally beyond a proximal end region of the outer layer, and where the cured material extends into and fills voids between braided filaments at the proximal end regions of the inner layer and the outer layer.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. patent application No. 17 / 816,380, filed on July 29, 2022, the entirety of which is incorporated herein by reference. Technical Field

[0003] The present technology relates generally to medical devices, and particularly to implantable devices for treating vascular defects. Background Art

[0004] An intracranial aneurysm is a portion of an intracranial blood vessel that bulges outward from the main channel of the vessel. This condition often occurs in a portion of a blood vessel that is abnormally fragile due to congenital anomalies, trauma, hypertension, or other reasons. Once an intracranial aneurysm forms, there is a significant risk that the aneurysm will eventually rupture and cause a high-risk medical emergency with death from bleeding. Vascular surgery is often indicated when an unruptured intracranial aneurysm is detected or when a patient survives the initial rupture of an intracranial aneurysm. One conventional type of vascular surgery used to treat intracranial aneurysms involves placing a platinum coil within the interior volume of the aneurysm using a microcatheter. Over time, the presence of the coil leads to the formation of a thrombus. Ideally, the neck of the aneurysm closes at the site of the thrombus and is replaced by new endothelial tissue. The blood then bypasses the aneurysm, thereby reducing the risk of aneurysm rupture (or re-rupture) and associated bleeding. Unfortunately, long-term recanalization (i.e., restoration of blood flow to the interior volume of the aneurysm) after this type of vascular surgery occurs in many cases, particularly for intracranial aneurysms with relatively wide necks and / or relatively large interior volumes.

[0005] Another conventional type of vascular surgery used to treat intracranial aneurysms involves the deployment of a flow shunt within the relevant intracranial vessel. A flow shunt is typically a mesh tube that allows blood to flow preferentially along the main channel of the vessel, while blood within the aneurysm stagnates. Stagnant blood within the aneurysm eventually thrombi, resulting in closure of the aneurysm neck and growth of new endothelial tissue, as with platinum coil therapy. A significant disadvantage of flow shunts is that it may take weeks or months for the aneurysm to thrombose, and it may take significantly longer for the aneurysm neck to be covered by endothelial cells to be fully effective. This delay may be unacceptable when the risk of aneurysm rupture (or re-rupture) is high. In addition, flow shunts often require antiplatelet therapy to prevent thrombus formation within the main channel of the vessel at the site of the flow shunt. Antiplatelet therapy may be contraindicated shortly after the initial aneurysm rupture occurs, because the risk of re-rupture is high at this time, and if re-rupture occurs, antiplatelet therapy often exacerbates intracranial bleeding. For these and other reasons, innovation is needed in the treatment of intracranial aneurysms. Summary of the invention

[0006] The present technology relates to occlusive devices for treating aneurysms and associated systems and methods. Some embodiments include an occlusive device comprising a plurality of braided filaments that are fixed to each other via a curing material at the proximal end of the occlusive device. Compared to conventional fixation devices that utilize one or more metal bands placed around the ends of the filaments, the curing material of the present technology extends into the gaps between the bundled filaments and holds them together without adding additional thickness to the braid. In some embodiments, one or more detachment features may be formed in the curing material that advantageously provide a low-profile connection mechanism between the occlusive device and the delivery system. The low-profile fixation and detachment device implemented by the curing material may be particularly beneficial for use in a system for treating cerebral aneurysms because the small vessels of the neurovascular system can only be accessed by catheters (e.g., microcatheters) with extremely small diameters.

[0007] The subject technology is for example based on various aspects described below, including reference Figures 2A to 8 Description. For convenience, various examples of aspects of the subject technology are described as numbered clauses (clauses 1, 2, 3, etc.). These are provided as examples and do not limit the subject technology.

[0008] 1. A treatment system comprising:

[0009] a delivery shaft having a proximal portion, a distal portion, and a lumen extending through the delivery shaft, wherein the distal portion is configured to be positioned within the blood vessel proximate the aneurysm;

[0010] a steering shaft slidably positioned within the lumen of the delivery shaft, the steering shaft having a proximal portion and a distal portion; and

[0011] An occlusive device configured for implantation in the aneurysm, the occlusive device having a proximal end, a distal end, and a longitudinal axis, wherein the occlusive device comprises a plurality of filaments fixed to each other at the proximal end of the occlusive device by a solidifying material, wherein the solidifying material has: a first region having a first diameter and a second region having a second diameter greater than the first diameter, the second region being located distal to the first region along the longitudinal axis of the occlusive device,

[0012] wherein the occluding device is disposed in a collapsed state within the lumen of the delivery shaft for delivery to the aneurysm and the occluding device is coupled to the manipulation shaft such that the distal portion of the manipulation shaft is positioned above the first region of the solidified material and proximal to the second region of the solidified material.

[0013] 2. A treatment system according to clause 1, wherein the first region of the solidified material defines a recess, and wherein the distal portion of the manipulation shaft includes an interlocking element configured to be received within the recess of the solidified material.

[0014] 3. A treatment system according to claim 1 or claim 2, wherein the solidifying material defines a channel extending longitudinally through the solidifying material, and wherein the treatment system also includes an injection shaft positioned within at least a portion of the manipulation shaft and extending distally through the channel.

[0015] 4. A treatment system according to clause 3, wherein the injection shaft is configured to receive the embolic composition passing through the injection shaft.

[0016] 5. A treatment system according to claim 3 or claim 4, wherein the injection shaft has: a proximal portion having a first outer diameter and a first inner diameter and a distal portion having a second outer diameter smaller than the first outer diameter and a second inner diameter smaller than the first inner diameter, and wherein the proximal portion of the injection shaft terminates distally before a proximal edge of the solidifying material, and the distal portion of the injection shaft extends through the channel in the solidifying material.

[0017] 6. A treatment system according to any one of clauses 1 to 5, wherein the solidifying material does not comprise metal strips.

[0018] 7. A therapeutic system according to any one of clauses 1 to 6, wherein the occlusive device comprises an inner layer of braided filaments and an outer layer of braided filaments, the inner layer and the outer layer each having a proximal end region, and wherein the proximal end region of the inner layer extends proximally beyond the proximal end region of the outer layer.

[0019] 8. A therapeutic system according to clause 7, wherein:

[0020] The first region of solidified material surrounds and secures a portion of the proximal end region of the inner layer that extends proximally beyond the outer layer, and

[0021] The second region of the solidified material surrounds and secures the proximal end regions of both the inner layer and the outer layer.

[0022] 9. A treatment system according to any one of clauses 1 to 8, wherein the solidifying material extends radially between the filaments at the proximal end of the occluding device.

[0023] 10. A treatment system comprising:

[0024] a delivery shaft having a proximal portion, a distal portion, and a lumen extending through the delivery shaft, wherein the distal portion is configured to be positioned within the blood vessel proximate the aneurysm;

[0025] a manipulation shaft slidably positioned within the lumen of the delivery shaft, the manipulation shaft having a proximal portion and a distal portion, and an interlocking element at the distal portion; and

[0026] an occlusion device configured for implantation within the aneurysm, the occlusion device having a proximal end, a distal end, and a longitudinal axis, wherein the occlusion device comprises a plurality of filaments secured to one another at the proximal end of the occlusion device by a solidifying material, wherein the solidifying material defines a recess that receives the interlocking element of the manipulation shaft therein,

[0027] wherein the interlocking element is configured to be movable into and out of the recess along a radial direction, and

[0028] wherein, when the occluding device is disposed in the delivery shaft, an inner surface defining the lumen of the delivery shaft prevents the interlocking elements of the manipulation shaft from radially lifting out of the recesses in the occluding device, thereby securing the occluding device to the manipulation shaft.

[0029] 11. A therapeutic system according to claim 10, wherein when the occluding device is pushed proximally out of the delivery shaft so that the solidified material is distal to the distal end of the delivery shaft, the interlocking element is free to lift radially away from the solidified material, thereby separating the occluding device from the manipulation shaft.

[0030] 12. A treatment system according to clause 10 or clause 11, wherein the solidifying material defines a channel extending through the solidifying material, and wherein the treatment system further comprises an injection shaft positioned within at least a portion of the manipulation shaft and extending distally through the channel.

[0031] 13. A treatment system according to clause 12, wherein the injection shaft is configured to receive an embolic composition passing through the injection shaft.

[0032] 14. A treatment system according to claim 12 or claim 13, wherein the injection shaft has: a proximal portion having a first outer diameter and a first inner diameter and a distal portion having a second outer diameter smaller than the first outer diameter and a second inner diameter smaller than the first inner diameter, and wherein the proximal portion of the injection shaft terminates distally before a proximal edge of the solidified material, and the distal portion of the injection shaft extends through the channel in the solidified material.

[0033] 15. A treatment system according to any one of clauses 10 to 14, wherein the solidifying material does not comprise metal strips.

[0034] 16. A therapeutic system according to any one of clauses 10 to 15, wherein the occlusive device comprises an inner layer of braided filaments and an outer layer of braided filaments, the inner layer and the outer layer each having a proximal end region, and wherein the proximal end region of the inner layer extends proximally beyond the proximal end region of the outer layer.

[0035] 17. A therapeutic system according to clause 16, wherein:

[0036] The first region of solidified material surrounds and secures a portion of the proximal end region of the inner layer that extends proximally beyond the outer layer, and

[0037] The second region of the solidified material surrounds and secures the proximal end regions of both the inner layer and the outer layer.

[0038] 18. A treatment system according to any one of clauses 10 to 17, wherein the solidifying material extends radially between the filaments at the proximal end of the occluding device.

[0039] 19. A treatment system according to any one of clauses 10 to 18, wherein the manipulation shaft comprises a plurality of interlocking elements and the solidified material comprises a plurality of recesses, each recess being configured to receive a separate one of the interlocking elements.

[0040] 20. A method comprising:

[0041] advancing a delivery system through the vasculature to a treatment site proximate the aneurysm, the delivery system comprising a delivery shaft, a manipulation shaft positioned within the delivery shaft, and an occlusion device positioned within the delivery shaft in a collapsed state, wherein the occlusion device comprises a plurality of braided filaments coupled to one another at a proximal end of the occlusion device by a solidifying material, and wherein a distal portion of the manipulation shaft extends beyond at least a portion of the solidifying material to secure the occlusion device to the manipulation shaft;

[0042] The occlusive device is separated from the manipulation shaft by withdrawing the delivery shaft proximally beyond the solidified material, thereby exposing the distal portion of the manipulation shaft and allowing the distal portion to be lifted radially away from the solidified material.

[0043] 21. A method according to clause 20, wherein the delivery system further includes an injection shaft having a distal region, wherein the distal region extends distally through the channel in the solidified material, and wherein the method further includes delivering embolic material through the injection shaft when at least a portion of the occluding device expands within the aneurysm.

[0044] 22. A treatment system comprising:

[0045] a delivery shaft having a proximal portion, a distal portion, and a lumen extending through the delivery shaft, wherein the distal portion is configured to be positioned within the blood vessel proximate the aneurysm;

[0046] a steering shaft slidably positioned within the lumen of the delivery shaft, the steering shaft having a proximal portion and a distal portion; and

[0047] An occlusive device configured for implantation in the aneurysm, the occlusive device having a proximal end, a distal end and a longitudinal axis, wherein the occlusive device comprises a plurality of filaments secured to each other at the proximal end of the occlusive device by a curing material, wherein the occlusive device comprises an inner layer of braided filaments and an outer layer of braided filaments, the inner layer of braided filaments and the outer layer of braided filaments each having a proximal end region, and wherein the proximal end region of the inner layer has an exposed portion extending proximally beyond the proximal end region of the outer layer, and wherein the curing material extends into and fills gaps between the braided filaments at the proximal end region of the inner layer and the proximal end region of the outer layer, and

[0048] wherein the occluding device is disposed in a collapsed state within the lumen of the delivery shaft for delivery to the aneurysm and the occluding device is coupled to the manipulation shaft such that the distal portion of the manipulation shaft is positioned above the exposed portion of the inner layer and proximal to the proximal end region of the outer layer.

[0049] 23. A therapeutic system according to clause 22, wherein the solidified material has: a first region having a first diameter and a second region having a second diameter greater than the first diameter, the second region being located distally of the first region along the longitudinal axis of the occluding device.

[0050] 24. A therapeutic system according to clause 23, wherein:

[0051] The first region of solidified material surrounds and secures a portion of the proximal end region of the inner layer that extends proximally beyond the outer layer, and

[0052] The second region of the solidified material surrounds and secures the proximal end regions of both the inner layer and the outer layer.

[0053] 25. The treatment system of clause 23, wherein the first region of the solidified material defines a recess, and wherein the distal portion of the manipulation shaft includes an interlocking element configured to be received within the recess of the solidified material.

[0054] 26. A treatment system according to any one of clauses 21 to 25, wherein the solidifying material defines a channel extending longitudinally therethrough, and wherein the treatment system further comprises an injection shaft positioned within at least a portion of the manipulation shaft and extending distally through the channel.

[0055] 27. The treatment system of clause 26, wherein the injection shaft is configured to receive an embolic composition therethrough.

[0056] 28. A treatment system according to claim 26, wherein the injection shaft has: a proximal portion having a first outer diameter and a first inner diameter and a distal portion having a second outer diameter smaller than the first outer diameter and a second inner diameter smaller than the first inner diameter, and wherein the proximal portion of the injection shaft terminates distally before a proximal edge of the solidified material and the distal portion of the injection shaft extends through the channel in the solidified material.

[0057] 29. A treatment system according to any one of clauses 21 to 28, wherein the solidifying material does not comprise metal strips.

[0058] 30. A therapeutic system according to any of clauses 21 to 29, wherein the solidified material forms a first layer over the exposed portion of the outer surface of the inner layer and a second layer over the radially inner surface of the inner layer. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Many aspects of the present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0060] Figure 1 is an axial cross-sectional view of a fixed portion of a prior art occluding device.

[0061] Figure 2A is a partial schematic diagram of a system for treating an aneurysm according to an embodiment of the present technology.

[0062] Figure 2B yes Figure 2A A partial schematic enlarged cross-sectional view of a distal portion of the system is shown.

[0063] Figure 2C is a partial schematic illustration of a proximal portion of an occluding device engaged with a delivery system constructed in accordance with several embodiments of the present technology.

[0064] Figure 2D is a photograph showing the proximal regions of the inner and outer layers secured by a curing material according to several embodiments of the present technology.

[0065] Figure 2E It is along Figure 2C A cross-sectional axial view taken along line 2E-2E in FIG. Figure 2E , the delivery axis and injection axis have been removed for ease of illustration.

[0066] Figure 2F is a cross-sectional axial view of a mold assembly constructed in accordance with several embodiments of the present technology.

[0067] Figure 2G is a partial schematic illustration of a proximal portion of an occluding device engaged with a delivery system constructed in accordance with several embodiments of the present technology.

[0068] Figure 3 is a cross-sectional view of a distal portion of a system for treating an aneurysm in accordance with an embodiment of the present technology.

[0069] Figure 4 yes Figure 3 A partially transparent perspective view of the distal portion is shown in FIG. Figure 4 , the system is shown in a fixed delivery configuration.

[0070] Figure 5 yes Figure 3 A partially transparent perspective view of the distal portion is shown in FIG. Figure 4 , the system is shown in an intermediate stage of releasing the implant.

[0071] Figure 6 is a cross-sectional view of a distal portion of a system for treating an aneurysm in accordance with an embodiment of the present technology.

[0072] Figure 7 yes Figure 6 A partially transparent perspective view of the distal portion is shown in FIG. Figure 7 , the system is shown in a fixed delivery configuration.

[0073] Figure 8 yes Figure 6 A partially transparent perspective view of the distal portion is shown in FIG. Figure 8 , the system is shown in an intermediate stage of releasing the implant. DETAILED DESCRIPTION

[0074] The present technology relates to devices, systems and methods for delivering occlusive devices and embolic fluids to treatment locations (such as aneurysms) in blood vessels. In some embodiments, the technology includes delivering the occlusive device to the treatment location via a delivery system, and before the occlusive device is disassembled from the delivery system, the embolic fluid is delivered to the aneurysm through the proximal end of the occlusive device. In order to maintain a large inner diameter through the occlusive device (to reduce the pressure required to push the embolic fluid), it is beneficial to minimize the number and / or size of the components at the proximal end. However, when the occlusive device includes multiple braided filaments and / or woven filaments, this may be particularly difficult. The free ends of the filaments need to be constrained so that the braid cannot spread out, and to prevent the breakage or damage of a single filament in the delivery system or once deployed in the aneurysm.

[0075] Conventional methods for constraining the free ends while maintaining the central lumen typically involve clamping the ends of the filaments between two metal bands. Examples of such prior art assemblies are Figure 1 . The filament end 30 is positioned between the outer metal band 10 and the inner metal band 20, and the lumen 40 extends through the inner metal band 20 and is defined by the inner metal band. One of the disadvantages of this approach is that the space occupied by the metal bands reduces the diameter of the flow channel for the embolic fluid. For example, the minimum wall thickness of each band ranges from 0.001 inches to 0.002 inches, which achieves a minimum accumulation of 0.002 inches to 0.004 inches across one side of the band. The inner and outer bands thus together occupy a minimum of 0.004 inches to 0.008 inches, which is, for example, about 25% to 50% of the total available space in a delivery catheter having an inner diameter of 0.017 inches (which is the smallest existing commercial microcatheter).

[0076] In order to reduce the wall thickness or accumulation of additional components inside the delivery catheter, the occlusion device of the present technology is fixed at their proximal ends by a solidified material and does not include any bands or other mechanical constraints. The solidified material can only add a nominal amount to the total thickness / diameter of the bundled filaments, thus providing 25% to 50% more space (relative to the band) in the delivery catheter, which can be used to expand the fluid channel passing through the fixed filament ends. The solidified material provides the additional advantage of being able to be molded to include one or more features that engage with the delivery system to facilitate the disengagement of the occlusion device, as described in more detail below.

[0077] I. Overview of the therapeutic system of the present invention

[0078] Figure 2A A system 100 for treating an aneurysm, such as a cerebral aneurysm, is shown in accordance with one or more embodiments of the present technology. Figure 2B is an enlarged cross-sectional view of a distal portion of system 100. Figure 2A and Figure 2B As shown in FIG. 1 , system 100 includes a delivery system 101, an occluding device 120 (shown in a collapsed delivery configuration), and an embolization kit 200. In some embodiments, system 100 does not include embolization kit 200. Occluding device 120 is configured to be removably coupled to delivery system 101, and delivery system 101 is configured to position occluding device 120 intravascularly within an aneurysm. Occluding device 120 may have a collapsed configuration (e.g., a collapsed configuration) for delivery to an aneurysm via a catheter. Figure 2B ) and an expanded deployed state for implantation into an aneurysm cavity.

[0079] The embolic kit 200 includes an embolic composition 202 and a syringe device 204 ("syringe 204") configured to be fluidically coupled to a proximal portion of the delivery system 101 for injecting the embolic composition 202 into the aneurysm cavity. The embolic composition 202 may be delivered to the space between the occluding device 120 and the dome of the aneurysm to fill and occlude the aneurysm cavity. Additionally or alternatively, once the occluding device 120 has been at least partially deployed in the aneurysm, the embolic composition 202 may be delivered to an interior region of the occluding device 120. The occluding device 120 prevents the embolic composition 202 from migrating into the parent vessel, and the occluding device 120 and the embolic composition 202 together prevent blood from flowing into the aneurysm. The bioabsorption of the embolic composition 202 and the endothelialization of the occluding device 120 cause complete degradation of the aneurysm wall, leaving a successfully remodeled (aneurysm-free) region of the vessel.

[0080] The embolic composition 202 can be any material suitable for forming a solid or semisolid structure (e.g., a hydrogel) that partially or completely occludes the lumen of the aneurysm. For example, the embolic composition 202 can include one or more polymers, such as synthetic polymers (e.g., poly(glycolide), poly(lactide), poly(vinyl alcohol)), biopolymers (e.g., chitosan, gelatin, silk, cellulose, alginate, hyaluronic acid), or combinations thereof. The embolic composition 202 can optionally include one or more components such as crosslinkers, stabilizers, thickeners, spacers, etc. to promote gelation and / or enhance storage stability. Optionally, the embolic composition 202 can include a contrast agent to enable visualization (e.g., iohexol, iopromide, ioversol, iopamidol, iodixanol, ioxilan, iothalamic acid / meglumine, iodixan / acid meglumine, diatrizoate / meglumine). The embolic composition 202 can be biodegradable or non-biodegradable.

[0081] Still reference Figure 2A and Figure 2B, the delivery system 101 has a proximal portion 101a configured to be positioned in vitro during treatment and a distal portion 101b configured to be positioned intravascularly at or within the aneurysm. The delivery system 101 may include a handle 102 at the proximal portion 101a and a plurality of elongated shafts extending between the handle 102 and the distal portion 101b. For example, the delivery system 101 may include a delivery shaft 108 (such as a microcatheter) and a manipulation shaft 110 ( Figure 2B ), which is configured to be slidably disposed within the lumen of the delivery shaft 108. The system 101 may optionally include an injection shaft 112 ( Figure 2B ), the injection shaft is configured to be disposed within the lumen of the manipulation shaft 110. In such embodiments, the injection shaft 112 may be slidably disposed within the lumen of the manipulation shaft 110, or the manipulation shaft 110 and the injection shaft 112 may be fixed to each other. The delivery system 101 and / or the manipulation shaft 110 is configured to be detachably coupled to the occlusion device 120 at its distal end portion, as described below with reference to Figures 3 to 8 Described in more detail.

[0082] The manipulation shaft 110 may have a proximal portion at the handle 102 and a distal portion 111 configured to releasably engage a portion of the occluding device 120 to secure the occluding device 120 to the delivery system 101. The manipulation shaft 110 may be moved within the delivery shaft 108 to position the occluding device 120 at a desired location. The manipulation shaft 110 may be sufficiently flexible to enable manipulation (e.g., advancement and / or retraction) of the occluding device 120 through a tortuous passage.

[0083] The injection shaft 112 can have a proximal portion at the proximal portion 101a of the delivery system 101 (eg, at the handle 102) and a distal portion 115 that terminates within the occlusion device 120, such as Figure 2B As shown. The proximal portion of the injection shaft 112 is configured to be fluidly connected to a syringe 204 or other device containing an embolic composition 202 (e.g., via a port 104 on the handle 102). The pressure generated at the syringe 204 causes the embolic composition 202 to flow through the lumen of the injection shaft 112 and into a space located distal to the proximal end of the occluding device 120, for example, to an interior area of ​​the occluding device 120 or to a space between a portion of the occluding device 120 and the dome of the aneurysm. Once the embolic composition 202 has sufficiently filled the aneurysm cavity and / or the occluding device 120, the occluding device 120 can be removed from the delivery system 101. The delivery system 101 including the injection shaft 112 can then be withdrawn from the treatment site. In some embodiments, the lumen of the injection shaft 112 can be configured to receive a guide wire therethrough.

[0084] In some embodiments, the injection shaft 112 does not extend proximally back to the proximal portion 101a of the delivery system 101, but rather terminates proximally at an intermediate position along the lumen of the steering shaft 110. For example, the injection shaft 112 can be an extension tube (not shown) attached to the distal end of the steering shaft 110. The proximal end of the injection shaft 112 can reside and be fixed to the inner surface of the steering shaft 110 that defines the steering shaft lumen, and the distal end of the injection shaft 112 extends beyond the distal end of the steering shaft 110. In such embodiments, the proximal portion of the steering shaft 110 can be configured to be fluidly coupled to the syringe 204 (or other source of embolic composition 202), and the lumen of the steering shaft 110 can be configured to receive and transfer the embolic composition to the injection shaft 112.

[0085] Figure 2C A cross-sectional view of a portion of the occluding device 120 is shown. Figure 2C 101 , wherein the proximal portion remains within the delivery shaft 108 and the occluding device 120 remains coupled to the delivery system 101 . Figure 2C The steering shaft 110 is removed. The occluding device 120 may include an elastic mesh 121 formed of a plurality of braided and / or woven filaments that have been shaped to assume a desired three-dimensional shape when unconstrained (e.g., released from the delivery shaft 108). The mesh 121 may have any shape or size in the expanded state that enables the mesh 121 to cover the neck of the aneurysm and have a porosity sufficient to prevent the embolic composition 202 from leaking into the parent vessel. Representative examples of grids suitable for use with system 100 are described in U.S. Patent No. 8,142,456, U.S. Patent No. 9,855,051, U.S. Patent No. 10,327,781, U.S. Patent Application Publication No. 2020 / 0187953, U.S. Patent Application Publication No. 2021 / 0128169 and U.S. Patent Application Publication No. 2021 / 0153872, and U.S. Application No. ________ filed on July 30, 2022 and entitled “DEVICES, SYSTEMS AND METHODS FOR TREATING ANEURYSMS” [Attorney Docket No. A0007246US01], the disclosures of which are incorporated herein by reference in their entirety.

[0086] The mesh 121 may be formed of metal wires, polymer wires, or both, and the wires may have shape memory and / or superelastic properties. The mesh 121 may be formed of 24, 32, 36, 48, 64, 72, 96, 128, or 144 filaments. The mesh 121 may be formed of a range of filament or wire sizes, such as wires having a diameter of about 0.0004 inches to about 0.0020 inches, or about 0.0009 inches to about 0.0012 inches. In some embodiments, the diameter of each of the wires or filaments is about 0.0004 inches, about 0.0005 inches, about 0.0006 inches, about 0.0007 inches, about 0.0008 inches, about 0.0009 inches, about 0.001 inches, about 0.0011 inches, about 0.0012 inches, about 0.0013 inches, about 0.0014 inches, about 0.0015 inches, about 0.0016 inches, about 0.0017 inches, about 0.0018 inches, about 0.0019 inches, or about 0.0020 inches.

[0087] like Figure 2C As best shown in FIG. 1 , in some embodiments, the mesh 121 may include an inner layer 122 and an outer layer 124, each of which includes a plurality of braided and / or woven filaments. The inner layer 122 and the outer layer 124 may have respective proximal end regions 132, 134 that meet at a proximal region of the occluding device 120. Distal ends (not shown) of the inner layer 122 and the outer layer 124 may be attached to each other at the distal end of the occluding device 120, or may be separately secured and / or spaced apart from each other.

[0088] Each of the proximal end regions 132, 134 terminates proximally at a respective proximal tip 133, 135. Figure 2C As shown in , in some embodiments, the first proximal end region and / or the first proximal tip and the second proximal end region and / or the second proximal tip are staggered along the longitudinal axis of the device 120 so that the proximal tip 133 of the inner layer 122 is proximal to and spaced apart from the proximal tip 135 of the second layer or outer layer 124. Thus, the proximal end region 132 of the inner layer 122 may include an exposed portion 143 that does not radially overlap the proximal end region 134 of the outer layer 124 and a covered portion 170 that radially overlaps the proximal end region 134 of the outer layer 124. In some embodiments, the proximal tip 135 of the outer layer 124 is proximal to and spaced apart from the proximal tip 133 of the inner layer 122.

[0089] The occlusive device 120 may also include a solidified material 140 that extends between and holds together the filaments of the first proximal end region 132 of the inner layer 122 and the second proximal end region 134 of the outer layer 124. Figure 2C and Figure 2D As shown in , the solidified material 140 can be disposed within and / or fill the interstices 131 between the filaments that make up the mesh 121, such that the filaments and the solidified material 140 together form a composite structure at the proximal end of the occluding device 120. The solidified material 140 can be applied to the proximal end regions 132, 134 in a flowable form (e.g., via insert molding, overmolding, injection molding, reflow, etc.), which advantageously allows the material to flow into and / or through the interstices between the layers and / or filaments, and also allows the final shape and thickness of the solidified material 140 to be controlled.

[0090] Depending on the delivery system requirements and manufacturing methods, the solidified material 140 may be confined in the space 131 below and between the outermost surfaces 151 of the bundled filaments 123 ( Figure 2D and Figure 2E ), and may not typically be disposed above and / or on the outermost surface 151 (e.g., if the outermost surface 151 contacts a mold or other element during an insert molding or reflow process). In some embodiments, the solidified material 140 is disposed in the space 131 below and between the outermost surfaces 151 of the bundled filaments 123 ( Figure 2D and Figure 2E ), and along the radial outer surface 138 of the proximal end region 134 of the outer layer 122, the radial outer surface 137 of the proximal end region 132 of the inner layer 124, the radial inner surface 139 of the inner layer 124, the outermost surface 151 of all or a portion of the radial inner surface 141 of the outer layer 122, and / or above each proximal end of the proximal ends 133, 135.

[0091] According to some aspects of the present disclosure, for example Figure 2C and Figure 2D As shown in FIG. , in some embodiments, the solidified material 140 is disposed only adjacent to the filaments 123 ( Figure 2D) within gaps 131 (shown schematically) between the filaments, including gaps between the filaments along the various layers and at the interface between the radially outer surface 137 of the inner layer 122 and the radially inner surface 138 of the outer layer 124, where the inner layer 122 and the outer layer 124 overlap at this interface. In several such embodiments, the solidified material 140 is not disposed on the outer surface 137 of the exposed portion 143 of the inner layer 122, the radially outer surface 138 of the outer layer 124, and / or the radially inner surface 139 of the inner layer 122. Although the solidified material 140 may be present at or near the radially outer surfaces of the aforementioned portions by filling the gaps 131 between the filaments at the corresponding surfaces, the solidified material 140 does not form a layer of material above the filaments. In these and other embodiments where the solidified material 140 does not form a layer above the radially inner surface of the inner layer 122, the outermost filament surface 151 and the solidified material 140 between the outermost filament surfaces 151 together define the lumen 127 ( Figure 2E ), which extends through the fixed proximal end regions 132, 134 and through which the injection shaft 112 can be positioned. Figure 1 ) In comparison, the proximal end regions 132, 134 of the filaments of the present technology are fixed without increasing the existing outer diameter defined by the bundled filaments and without occupying the inner diameter extending through the bundled filaments.

[0092] According to some embodiments, Figure 2C and Figure 2D The composite structure shown in FIG. 1 can be formed by an overmolding process such as insert molding, injection molding, etc. Figure 2F As shown in , the mold assembly 160 may include an outer member 150 having a lumen approximately equal to the outer diameter of the composite structure and an inner member 152 having an outer diameter approximately equal to the outer diameter of the injection shaft 112. The proximal end regions 132, 134 may be inserted into the mold between the outer member 150 and the inner member 152, and a curing material in liquid form may be injected between the outer member 150 and the inner member 152 and allowed to cure (e.g., harden, solidify, etc.). Figure 2E and Figure 2F As shown, because the filament 123 is tightly sandwiched between the outer member 150 and the inner member 152, when the filament 123 is removed from the mold, the portion of the surface of the filament (such as the outermost surface 151, only a few are marked) that presses against the outer member 150 or the inner member 152 may be free of any curable material 140. The material can be any suitable curable material, such as an injectable adhesive, liquid plastic, and / or other composite material. In some embodiments, the material is a UV curable epoxy resin. In some embodiments, the curable material 140 is a single-piece body.

[0093] refer to Figure 2GIn some embodiments, the solidified material 140 forms at least one of: a first layer 176 on and along all or a portion of the radially outer surface 138 of the proximal end region 134 of the outer layer 124, a second layer 174 on and along all or a portion of the radially outer surface 137 of the proximal end region 132 of the inner layer 122, and / or a third layer 172 on and along all or a portion of the radially inner surface 139 of the inner layer 122. The layers 172, 174, and 176 may be disposed on top of the solidified material 140 within the outermost surface 151 of the filaments and the voids 131. In such embodiments where the solidified material 140 forms a layer 172 over the radially inner surface of the inner layer 122 along the proximal end region 132, the solidified material 140 defines a lumen 126 that extends through the fixed proximal end regions 132, 134 and through which the injection shaft 112 may be positioned. Compared to conventional metal strips, the cured material 140 may conform to the step created by the staggered proximal ends 132 , 134 .

[0094] According to some manufacturing methods, Figure 2G The layers of the composite structure can be formed by reflowing a solid material over the filaments. The solid material can be a thermoplastic material such as Pebax ® , polyolefins, polyvinyl chloride (PVC), fluoropolymers, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), Kynar ® 、Viton ® In some embodiments, a first layer of solid material (in the form of a wrap, tube, strip, etc.) may be placed on the inner member 152 of the mold (see Figure 2F ), and the inner layer 122 and the outer layer 124 are placed over the first layer. A second layer of solid material (in the form of a wrap, tube, strip, etc.) may be placed over the proximal end regions of the inner layer 122 and the outer layer 124, and a shrink tube (e.g., PTFE, etc.) is placed over the entire assembly. Heat is then applied to the assembly, causing the shrink tube to generate a radially inward force while the thermoplastic layer melts into the pores of the braid, which once hardened produces a composite structure including filaments and solidified material.

[0095] The completed assembly includes a layer of solidified material 140 (formed by reflowing the second layer) on the radially outer surface 138 of the outer layer 124 and a layer of solidified material 140 (formed by reflowing the first layer) on the radially inner surface of the inner layer 122. In some embodiments, other techniques (such as an overmolding process using a standoff between the filament and the mold surface) may be used to form one, some, or all of the layers 172, 174, 176.

[0096] refer to Figure 2G Due to the staggered arrangement of the proximal end regions 132, 134 of the grid 121, the outer diameter of the composite structure along the second layer 174 of the solidified material 140 is greater than the outer diameter of the composite structure along the second region 144, thereby forming a shelf 145 in the solidified material 140. The shelf 145 can be defined by the second layer 174 and the proximally facing annular surface 136 formed by the step between the second layer 174 and the first layer 176. As described in detail below, the shelf 145 formed by the solidified material 140 can be manipulated by the shaft 110 ( Figure 2B ) engage to secure the occluding device 120 to the operating shaft 110 and / or act as a lever to push the occluding device 120 out of the operating shaft 110.

[0097] It should be understood that the solidified material 140 can be used with single-layer occlusion devices as well as multi-layer occlusion devices that do not have staggered proximal ends (i.e., have aligned proximal ends). Although the topography created by the staggered mesh layers can help form the shelf 145 in the solidified material 140, the solidified material 140 can be molded during manufacturing to include any shape, including the shelf 145, regardless of the underlying mesh topography. In addition, in any of the foregoing embodiments, the solidified material 140 can be loaded with a radiopaque material, such as barium sulfate, bismuth subcarbonate, etc., to enhance intraoperative visualization.

[0098] II. Selected embodiments of disassembly areas and methods of use

[0099] The solidified material 140 of the present technology and / or the composite structure formed by the solidified material 140 and the filaments can be configured to engage with one or more components of the delivery system 101 to releasably secure the occlusive device 120 to the delivery system 101. For example, Figures 3 to 5 As shown in the delivery system 301, in some embodiments, the solidified material 340 can be configured to be attached to the distal portion 111 ( Figure 2B ) can be releasably interlocked to secure the occluding device 120 to the delivery system 101. The solidifying material 340 can have the same Figures 2A to 2G The same features as discussed above for the solidified material 140, except that the shelf 145 of the solidified material 340 includes one or more recesses 350 (in Figure 5). Likewise, the delivery system 301 can have the same features and components as the delivery system 101, except that the distal portion 111 of the manipulation shaft 110 of the delivery system 301 includes one or more interlocking elements 370 that are configured to be received by the recess 350 in the solidified material 140. When the interlocking element 370 is positioned within the recess 350 of the solidified material 140 and the delivery shaft 108 is positioned radially above the interlocking element 370, the delivery shaft 108 prevents the interlocking element 370 from lifting out of the recess 350, thereby securing the occlusion device 120 to the delivery system 101. Figure 5 As shown, when the occluder device 120 is advanced distally such that the interlocking element 370 is positioned distal to the distal end of the delivery shaft 108 , the interlocking element 370 is free to lift out of the recess 350 , thereby allowing the delivery system 101 to be withdrawn proximally and disengaged from the occluder device 120 .

[0100] In some embodiments, the steering shaft 110 has a distal edge 372 ( Figure 4 and Figure 5 ), and the interlocking element 370 includes a plurality of tabs extending distally away from the edge 372. Figures 3 to 5 370, but the manipulation shaft 110 may have any number of interlocking elements 370 (e.g., one interlocking element, three interlocking elements, four interlocking elements, five interlocking elements, six interlocking elements, etc.). Each of the interlocking elements 370 may include a stem 374 extending longitudinally away from the distal edge 372 and a head 376 disposed at the distal end of the stem 374. The recess 350 may have a shape that is complementary to the shape of the interlocking element 370. The width of the head 376 may be greater than the width of the stem 374, so that the proximal-facing surface of the head 376 abuts the distal-facing surface of the solidified material 140 that defines the recess 350. Therefore, when the interlocking element 370 is located in the recess 350, the solidified material 140 prevents the interlocking element 370 from sliding proximally relative to the solidified material 140 and / or the occluding device 120. Thus, when the interlocking element 370 is positioned within the lumen of the delivery shaft 108 and is prevented from lifting out of the recess 350, distal movement of the manipulator shaft 110 pushes the occlusion device 120 distally (e.g., to push the occlusion device 120 out of the delivery shaft 108 and into the aneurysm), and proximal movement of the manipulator shaft 110 pulls the occlusion device 120 proximally (e.g., to reinsert the occlusion device 120 into the delivery shaft 108 as needed for repositioning).

[0101] It should be understood that the interlocking element 370 may have other Figures 3 to 5. For example, in some embodiments, one, some, or all of the interlocking portions 330 may have a substantially constant width along their length. According to several embodiments, the head 376 may have a non-circular or circular shape, such as a T-shape. Likewise, the recess 350 in the solidified material 140 may have other suitable shapes.

[0102] Because the inner diameter of the manipulation shaft 110 is larger than the inner diameter of the passageway extending through the solidified material 340, the outer diameter of the injection shaft 112 can taper proximally. In some embodiments, both the outer diameter and the inner diameter of the injection shaft 112 can taper proximally. For example, Figure 3 As shown, the injection shaft 112 may have a first more proximal portion 112a and a second more distal portion 112b, wherein the first more proximal portion has a first outer diameter and a first inner diameter, and the second more distal portion has a second outer diameter and a second inner diameter, which are respectively smaller than the outer diameter and the inner diameter of the first portion 112a.

[0103] Figures 6 to 8 Another embodiment of a delivery system 601 is shown, which includes a tube 680 extending between the distal portion 111 of the steering shaft 110 and the proximal portion of the solidified material 140. The solidified material 640 may have the same FIG. 2A to FIG. 2C Similarly, the delivery system 601 can have the same features and components as the delivery system 101, except that the distal portion 111 of the steering shaft 110 of the delivery system 601 has a reduced outer diameter relative to the remainder of the steering shaft 110. For example, the steering shaft 110 can have a proximal portion 117 having a first diameter, and the distal portion 111 can have a second diameter that is smaller than the diameter of the proximal portion 117. In some embodiments, the reduced diameter of the distal portion 111 can be substantially the same as the diameter of the composite structure along the second layer 174 of the solidified material 140. The inner diameter of the steering shaft 110 can remain the same between the proximal portion 117 and the distal portion 111.

[0104] In some embodiments, the proximal portion 686 of the tube 680 is coupled to the distal portion 111 of the steering shaft 110, while the distal portion 688 of the tube 680 is not adhered to the shelf 145 of the solidified material 640 ( Figure 6 ), and is held to the solidified material 640 only by the restraining force of the inner surface of the delivery shaft 108. In some embodiments, the distal portion 688 of the tube 680 includes a first longitudinal slit and a second longitudinal slit 682 (at Figure 7In any event, the slits 682 can separate the tube 680 into a first flexible region and a second flexible region 684, which are free to lift radially away from the solidified material 640 when the distal end of the delivery shaft 108 is pulled to a position proximal to the flexible region 684 so that the flexible region 684 is exposed. The steering shaft 110 can be pulled proximally to release the composite structure through the flexible region 684. Once the composite structure is released and delivery of the embolic composition 202 is complete, the injection shaft 112 can be withdrawn from the passage extending through the composite structure. The delivery system can then be withdrawn from the body, leaving the occluding device 120 implanted in the aneurysm. Although in Figure 7 and Figure 8 Two slits 682 and two flexible regions 684 are shown in FIG, but the tube 680 may have any number of slits 682 and flexible regions 684 (eg, three slits and three flexible regions, four slits and four flexible regions, etc.).

[0105] In some embodiments, the tube 680 is a thermoplastic tube (or "shrink tube") or other thin-walled polymer tube. In those embodiments where the tube 680 is a shrink tube, the slit 682 can be cut into the shrink tube after it has shrunk. In other embodiments, the tube 680 can have other configurations, such as a strip of material (not shown) having a proximal end bonded to a location along the distal portion 110b of the steering shaft 110. The remainder of the strip can be wrapped around the distal portion 110b of the curing material 640 and the shelf 145 ( Figure 6 ) around. The band can be formed of a shrinkable material or other material. In some embodiments, the mating surfaces of the solidified material 640 and / or the flexure zone 684 can be textured to increase the coefficient of friction and thus improve retention, but still allow release when the delivery shaft 108 is withdrawn. In addition, the mating surfaces of the solidified material 640 and / or the flexure zone 684 can be formed to include topographical features, such as rings, teeth, and / or other textures, that interlock with topographical features on the mating surface of the other of the solidified material 640 or the flexure zone 684.

[0106] in conclusion

[0107] Although many of the embodiments are described above with respect to systems, devices, and methods for securing and delivering occlusive devices to neurovascular aneurysms, the technology is applicable to other applications and / or other methods, such as securing and delivering other non-braided and / or non-occlusive devices, treating vascular disease other than aneurysms, and treating vascular disease in other parts of the vasculature. In addition, other embodiments than those described herein are also within the scope of the present technology. In addition, several other embodiments of the present technology may have different configurations, components, or procedures than those described herein. Therefore, a person of ordinary skill in the art will accordingly understand that the present technology may have other embodiments with additional elements, or the present technology may have other embodiments without the above references. Figures 2A to 8 Other embodiments of several features are shown and described.

[0108] The description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the exact form disclosed above. Where the context permits, singular terms or plural terms may also include plural terms or singular terms, respectively. Although the above describes the specific embodiments and examples of the present technology for illustrative purposes, it should be recognized by those skilled in the relevant art that various equivalent modifications may be made within the scope of the present technology. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in different orders. The various embodiments described herein may also be combined to provide additional embodiments.

[0109] As used herein, the terms "substantially," "substantially," "about" and similar terms are used as terms of approximation rather than terms of degree, and are intended to take into account the inherent variations in measured or calculated values ​​that those of ordinary skill in the art will recognize.

[0110] In addition, unless the word "or" is explicitly limited to referring only to a single item excluding other items when referring to a list of two or more items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term "comprising" is used throughout the text to mean including at least the described features, so that any greater number of the same features and / or other features of additional types are not excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the present technology. In addition, although the advantages associated with certain embodiments of the present technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments are required to exhibit such advantages to fall within the scope of the present technology. Therefore, the present disclosure and associated technology may cover other embodiments not explicitly shown or described herein.

Claims

1. A treatment system comprising: a delivery shaft having a proximal portion, a distal portion, and a lumen extending through the delivery shaft, wherein the distal portion is configured to be positioned within the blood vessel proximate the aneurysm; a manipulation shaft slidably positioned within the lumen of the delivery shaft, the manipulation shaft having a proximal portion and a distal portion; and An occlusive device configured for implantation in the aneurysm, the occlusive device having a proximal end, a distal end and a longitudinal axis, wherein the occlusive device comprises a plurality of filaments secured to each other at the proximal end of the occlusive device by a curing material, wherein the occlusive device comprises an inner layer of braided filaments and an outer layer of braided filaments, the inner layer of braided filaments and the outer layer of braided filaments each having a proximal end region, and wherein the proximal end region of the inner layer has an exposed portion extending proximally beyond the proximal end region of the outer layer, and wherein the curing material extends into and fills gaps between the braided filaments at the proximal end region of the inner layer and the proximal end region of the outer layer, and wherein the occluding device is disposed in a collapsed state within the lumen of the delivery shaft for delivery to the aneurysm and the occluding device is coupled to the manipulation shaft such that the distal portion of the manipulation shaft is positioned above the exposed portion of the inner layer and proximal to the proximal end region of the outer layer.

2. The treatment system of claim 1, wherein the solidified material comprises: a first region having a first diameter and a second region having a second diameter greater than the first diameter, the second region being located distal to the first region along the longitudinal axis of the occluding device.

3. The therapeutic system of claim 2, wherein: The first region of the solidified material surrounds and secures the proximal end region of the inner layer extending proximally beyond the exposed portion of the outer layer, and The second region of the solidified material surrounds and secures the proximal end regions of both the inner layer and the outer layer.

4. The treatment system of claim 2, wherein the first region of the solidified material defines a recess, and wherein the distal portion of the manipulation shaft includes an interlocking element configured to be received within the recess of the solidified material.

5. A treatment system according to any one of claims 1 to 4, wherein the solidified material defines a channel extending longitudinally through the solidified material.

6. The treatment system of claim 5, wherein the treatment system further comprises an injection shaft positioned within at least a portion of the manipulation shaft and extending distally through the channel.

7. The treatment system of claim 6, wherein the injection shaft is configured to receive an embolic composition therethrough.

8. The treatment system of claim 7, wherein the occluding device is configured to be positioned over a neck of the aneurysm, the neck connecting the aneurysm cavity to a parent vessel, and wherein the occluding device has a porosity sufficient to prevent leakage of the embolic composition through the neck into the parent vessel.

9. A treatment system according to any one of claims 6 to 8, wherein the injection shaft has: a proximal portion having a first outer diameter and a first inner diameter and a distal portion having a second outer diameter smaller than the first outer diameter and a second inner diameter smaller than the first inner diameter, and wherein the proximal portion of the injection shaft terminates distally before a proximal edge of the solidified material, and the distal portion of the injection shaft extends through the channel in the solidified material.

10. The treatment system of any one of claims 1 to 9, wherein the solidifying material does not include metal strips.

11. The treatment system of any one of claims 1 to 10, wherein the solidified material forms a first layer over the exposed portion of the outer surface of the inner layer and a second layer over the radially inner surface of the inner layer.

12. The treatment system of any one of claims 1 to 11, wherein the solidified material comprises a hardened adhesive.

13. The treatment system of any one of claims 1 to 11, wherein the solidified material comprises plastic.

14. The treatment system of any one of claims 1 to 11, wherein the curable material comprises a UV curable epoxy resin.

15. The therapeutic system of any one of claims 1 to 14, wherein the filaments comprise an elastic material and have been shaped such that the occlusive device assumes a predetermined three-dimensional shape when unconstrained.

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