ANEURYSM METHOD AND SYSTEM

Abstract

A vaso-occlusive device is disclosed herein having a delivery configuration when restrained within a delivery catheter and a deployed configuration when released from the delivery catheter into an aneurysmal sac. The vaso-occlusive device includes a tubular structure and an elongated embolic element. The tubular structure is configured to form at least two nested sacks within the aneurysm, thereby creating a multi-layer scaffolding within the aneurysm sac. The elongate embolic element is coupled to proximal end of the tubular structure and is configured to fill an interior region of the multi-layer scaffolding when deployed into the aneurysmal sac. At least one of the two nested sacks can be inverted upon deployment. The tubular structure can include a tubular braided mesh.

Claims

1. A vaso-occlusive device having a delivery configuration when restrained within a delivery catheter and a deployed configuration when released from the delivery catheter into an aneurysmal sac, the vaso-occlusive device comprising: a tubular structure, comprising: a distal portion configured to form a first sack within the aneurysmal sac when distally deployed from the delivery catheter into the aneurysmal sac, a proximal portion configured to form a second sack within the first sack when distally deployed from the delivery catheter, thereby creating multi-layer scaffolding within the aneurysmal sac; and an elongate embolic element coupled to proximal end of the tubular structure, wherein the elongate embolic element is configured to fill an interior region of the multi-layer scaffolding when distally deployed from the delivery catheter into the aneurysmal sac.

2. The vaso-occlusive device of claim 1, wherein the tubular structure comprises a tubular braided mesh.

3. The vaso-occlusive device of claim 1, wherein the elongate embolic element comprises a braided ribbon.

4. The vaso-occlusive device of claim 1, wherein the elongate embolic element comprises an embolic coil.

5. The vaso-occlusive device of claim 1, wherein at least one of the distal portion and the proximal portion is configured to invert upon movement of the vaso-occlusive device from the delivery configuration to the deployed configuration.

6. The vaso-occlusive device of claim 5, wherein the tubular structure further comprises an inflection region between the distal portion and the proximal portion, the inflection region configured to urge the inversion of the proximal portion and/or urge the inversion of the distal portion.

7. The vaso-occlusive device of claim 6, wherein the inflection region is configured for urging the inversion of the proximal portion and/or the distal portion while the vaso-occlusion device moves from the delivery configuration to the deployed configuration in free-space.

8. The vaso-occlusive device of claim 1, wherein each of the distal portion and the proximal portion is configured for self-expanding into a spherical, oblong, or saddle shape.

9. The vaso-occlusive device of claim 1, wherein the distal portion comprises a non-expanding terminal end.

10. An implant configured to traverse vasculature within a delivery catheter and move from a delivery configuration with restrained by the delivery catheter to a deployed configuration within a spherical cavity, the implant comprising: an expandable tubular braid comprising a first portion configured to form a first sack conformal to walls of the spherical cavity and a second portion configured to form a second sack within the first sack when the implant moves from the delivery configuration to the deployed configuration; and an elongate embolic element coupled to the tubular braid and configured to be positioned within the first sack and the second sack when the implant moves from the delivery configuration to the deployed configuration.

11. The implant of claim 10, wherein the elongate embolic element comprises a braided ribbon.

12. The implant of claim 10, wherein the elongate embolic element comprises an embolic coil.

13. The implant of claim 10, wherein at least one of the first portion and the second portion is configured to invert upon movement of the implant from the delivery configuration to the deployed configuration.

14. A method of treating an aneurysm in a patient, the method comprising: distally advancing a vaso-occlusive device in a delivery configuration through a delivery catheter to an aneurysm neck, the vaso-occlusive device comprising a tubular structure and an elongated embolic element coupled to a proximal end of the tubular structure; deploying a distal portion of the tubular structure from a distal end of the delivery catheter into a sac of the aneurysm; expanding the distal portion of the tubular structure, thereby creating a single-layer scaffolding that lines a wall of the aneurysm sac; deploying a proximal portion of the tubular structure from the distal end of the delivery catheter; expanding the proximal portion of the tubular structure within the expanded distal portion of the tubular structure, thereby creating a multi-layer scaffolding that lines the wall of the aneurysm sac; and positioning the elongated embolic element within the multi-layer scaffolding.

15. The method of claim 14, wherein the tubular structure comprises a tubular braided mesh.

16. The method of claim 14, wherein the elongate embolic element comprises an embolization coil and/or a braided ribbon.

17. The method of claim 14, further comprising: inverting at least of the distal portion and the proximal portion upon deployment of the tubular structure from the distal end of the delivery catheter.

18. The method of claim 17, wherein the tubular structure further comprises an inflection region between the distal portion and the proximal portion, the inflection region configured to urge the inversion of the proximal portion and/or urge the inversion of the distal portion.

19. The method of claim 18, wherein inversion of the tubular structure at the inflection region is initiated absent an application of an opposing proximal force on the tubular structure by a dome of the aneurysmal sac.

20. The method of claim 14, further comprising: expanding each of the distal portion and the proximal portion respectively into a spherical, oblong, or saddle shape.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Reference will now be made to the accompanying drawings, which are not necessarily drawn to scale.

[0038] FIG. 1 depicts an example occlusion device of this disclosure deployed into an aneurysm.

[0039] FIG. 2 is a schematic side view of an exemplary delivery system with an occlusion device held in a collapsed condition within a microcatheter.

[0040] FIG. 3 is an enlarged schematic side view of the delivery system of FIG. 2 along section A-A;

[0041] FIG. 4 is a flow diagram for a method of delivering an occlusion device to the vasculature using the herein disclosed delivery system;

[0042] FIG. 5A is an enlarged schematic side view of the delivery system of FIG. 2 along section B-B of FIG. 4;

[0043] FIG. 5B is an enlarged schematic side view of the delivery system of FIG. 2 along section C-C of FIG. 4;

[0044] FIG. 5C is an enlarged schematic side view of the delivery system of FIG. 2 along section D-D of FIG. 4;

[0045] FIG. 5D is an enlarged schematic side view of the delivery system of FIG. 2 along section E-E of FIG. 4;

[0046] FIG. 6A is an enlarged perspective schematic view of section F-F across its center line showing an exemplary proximal implant end of the braid in communication with an exemplary pushing mechanism;

[0047] FIG. 6B is an enlarged schematic overview showing an exemplary attachment system as between a delivery tube, pushing mechanism and catheter in an embodiment of the delivery system;

[0048] FIG. 6C is an enlarged schematic view showing an exemplary attachment system as between a delivery tube, pushing mechanism and catheter in an embodiment of the delivery system.

[0049] FIG. 6D is an enlarged schematic view showing an exemplary attachment system as between a delivery tube, pushing mechanism and catheter in an embodiment of the delivery system.

[0050] FIG. 6E is an enlarged schematic view showing an exemplary attachment system as between a delivery tube, pushing mechanism with the catheter removed in an embodiment of the delivery system.

[0051] FIG. 6F is an enlarged schematic view showing an exemplary attachment system as between a delivery tube, pushing mechanism with the catheter removed in an embodiment of the delivery system.

[0052] FIG. 7 is an enlarged schematic side view of the attachment system of FIG. 6E along section G-G.

[0053] FIG. 8 is a schematic side view of an exemplary delivery system with an occlusion device being deployed with an embolic coil.

[0054] FIG. 9 is a flow diagram for a method of delivering an occlusion device.

[0055] FIG. 10 is a flow diagram for a method of delivering an occlusion device using the herein disclosed delivery system.

[0056] FIG. 11A depicts an example braid of this disclosure.

[0057] FIG. 11B depicts an example braid of this disclosure deployed.

[0058] FIG. 11C depicts an example braid with embolic coil of this disclosure.

[0059] FIG. 12A is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapsed condition to a deployed condition.

[0060] FIG. 12B is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapsed condition to a deployed condition.

[0061] FIG. 12C is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapsed condition to a deployed condition.

[0062] FIG. 12D is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapse0d condition to a deployed condition.

[0063] FIG. 12E is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapsed condition to a deployed condition.

[0064] FIG. 12F is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapsed condition to a deployed condition.

[0065] FIG. 12G is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapsed condition to a deployed condition.

[0066] FIG. 12H is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapsed condition to a deployed condition.

[0067] FIG. 12I is an enlarged view one step of an exemplary delivery system device being deployed into an aneurysm in accordance with this disclosure, wherein the system is shown moving from a collapsed condition to a deployed condition.

DETAILED DESCRIPTION

[0068] Although example embodiments of the disclosed technology are explained in detail herein, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the disclosed technology be limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The disclosed technology is capable of other embodiments and of being practiced or carried out in various ways.

[0069] It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. By “comprising” or “containing” or “including” it is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

[0070] In describing example embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. It is also to be understood that the mention of one or more steps of a method does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Steps of a method may be performed in a different order than those described herein without departing from the scope of the disclosed technology. Similarly, it is also to be understood that the mention of one or more components in a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.

[0071] As discussed herein, vasculature of a “subject” or “patient” may be vasculature of a human or any animal. It should be appreciated that an animal may be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc. As an example, the animal may be a laboratory animal specifically selected to have certain characteristics similar to a human (e.g., rat, dog, pig, monkey, or the like). It should be appreciated that the subject may be any applicable human patient, for example.

[0072] As discussed herein, “operator” may include a doctor, surgeon, or any other individual or delivery instrumentation associated with delivery of a braid body to the vasculature of a subject.

[0073] Cerebrovascular aneurysms are known to be treated using embolic coils, which are delivered to the aneurysm sack via a microcatheter and detached in situ. It is understood that “packing density” is the volume of the aneurysm sack occupied by the coil mass. In previous coil approaches, multiple coils (e.g. five coils) have been used to pack the aneurysms and the packing density can typically range between 15-25%, depending on the aneurysm size. The herein disclosed device improves on use of embolic coils by using a single device without a need for even a single coil to pack the device. Instead, the disclosed device is operable to seal the aneurysm neck and pack the aneurysm to a higher packing density than using coils. In practice, the packing density can be as increased 25-50% depending on the length of braid in the aneurysm, or double what can be achieved with conventional coils. However, the multiple braid layers formed as the braid packs the aneurysm may mean that a lower packing density may achieve blood flow alteration and coagulation in a way that a lower packing density may achieve the same level of occlusion. This allows for the aneurysm neck to heal.

[0074] In contrast, in previous embolic-based approaches, packing the aneurysm required in placement of coils into the aneurysm sack until the aneurysm obtained the desired packing density to occlude the aneurysm. However, obtaining such a packing density was difficult, time consuming, and aneurysm morphology (e.g. wide neck, bifurcation, etc.), and the like required ancillary devices such a stents or balloons to support the coil mass and obtain the desired packing density. Furthermore, aneurysms treated with multiple coils often reanalyze or compact as a result of poor coiling, lack of coverage across the aneurysm neck, as a result of flow, or even aneurysm size.

[0075] The occlusion device 1 and corresponding delivery system 30 disclosed herein addresses the drawbacks of previous approaches, including low packing density, compaction and recanalization of aneurysms.

[0076] Turning to FIG. 1, an example occlusion device 1 of this disclosure is shown deployed into an aneurysm A of blood vessel BV but not yet released from its delivery system. The catheter 20 has been delivered to the aneurysm A and as shown and discussed more particularly below, occlusive sack 12 of braided tubular implant 10 (hereinafter also referred to “braid” or “braid 10”) of device 1 has formed a predetermined shape and structure that outlines and supports the walls of the aneurysm A so as to occlude aneurysm A.

[0077] FIG. 2 depicts a schematic side view of braid 10 and delivery system 30 prior to being positioned in a location of interest in the vasculature for occluding aneurysm A. The braid 10 can include a lumen with a distal implant end 16 opposite a proximal implant end 14, as shown more particularly in FIG. 3. Specifically, FIG. 3 is an enlarged schematic side view of the delivery system of FIG. 2 along section A-A prior to deployment. System 30 can include a pusher delivery tube 34 with an inner lumen and a braid pushing mechanism 38. System 30 can deliver an occlusive device, which includes braid 10, to a location of interest (e.g. a lesion site) using a microcatheter 20. System 30 may be preplaced in microcatheter 20. In certain embodiments, microcatheter 20 can be pre-placed, with or without system 30, at a level of the aneurysm neck and used to track the device 1 to the lesion. Mechanism 38 may be tubular, solid, elongate, and/or be pliable to be able to pass through tortuous pathways of the vasculature within delivery tube 34 and/or microcatheter 20. Mechanism 38 can include an inner lumen and be disposable or capable of functioning with a hypotube. For example, a hypotube can be attached or in communication with mechanism 38 to distally slide mechanism 38 toward the aneurysm A.

[0078] In this respect, mechanism 38 may be slidably disposed within delivery tube 34, wherein mechanism 38 can be in mechanical connection with braid 10 at attachment 36. When braid 10 is mechanically attached to pushing mechanism 38 at attachment 36, distally translating, sliding, or otherwise moving mechanism 38 toward the aneurysm can cause a distal implant end 16 of braid 10 to begin moving from a collapsed condition to a deployed condition, as discussed below. Both delivery tube 34 and mechanism 38 can extend from the proximal 24 to the distal end 26 of microcatheter 20.

[0079] It is understood that braid 10 can include a self-expanding braid for treating an aneurysm. The inner lumen of braid 10 can form a self-expanding multi-filament outer surface that can include a mesh. It can be seen that mechanism 38 is disposed proximal of braid 10 and braid 10 is in communication with mechanism 38 across attachment 36 at proximal implant end 14. Braid 10 may be attached to attachment 36 by being crimped thereon or by a detachable connection. In certain embodiments, proximal implant end 14 may be inserted within the distal end of mechanism 38 at attachment 36 wherein mechanism 38 can then be attached therewith or thereon. However, attachment 36 is not so limited and instead braid 10 may be slidably, detachably inserted over or otherwise with attachment 36.

[0080] Prior to deployment within an aneurysm A, distal implant end 16 of braid 10 is adjacent or in contact with distal end 46 of delivery tube 34. Delivery tube 34 may also include one or more fasteners 32 operable to securely fasten braid 10 in place prior to deployment. The area of braid 10 of distal implant end 16 adjacent or in communication with fastener 32 may be substantially atraumatic and/or rounded so to minimize kinking or other damage to the adjacent area of braid 10. Fastener 32 may include a crimping, soldering, bracing, adhesive, pressure cuff, welding, or other fastener means, including clamps, or the like, so that delivery tube 34 is secured therewith but translation of mechanism 38 and braid 10 is still permitted when actuation is desired.

[0081] Braid 10 may be operable to expand over the neck of the aneurysm A during delivery which can substantially reduce and/or prevent further blood flow from the parent vessel into the aneurysm sac. Portions of braid 10 on or proximate end 16 may be more pliable than portions of braid 10 on or proximate end 14 in order to induce self-expansion during delivery and inversion as braid 10 forms its predetermined, sack-like shape within aneurysm A (see, e.g., FIG. 1). The braid 10, including its outer surface, can be self-expanding and made from nitinol with interwoven platinum filaments for radiopacity. Braid 10 is not so limited, however, and any material or combination of materials can be used to form an outer surface of braid 10 can be used as needed or required.

[0082] Turning to FIG. 4, a flow diagram for a method 400 is shown for safely and precisely delivering an example braid 10 to the vasculature. As can be seen, in step 405 of method 400, the occlusion device 1 is assembled with a microcatheter 20. The assembly between microcatheter 20 and device 1 can take place before being introduced into the vasculature. In step 410, device 1, including system 30, may now have been selectively positioned at the lesion site and mechanism 38 can begin its distal translation of the braid 10. As can be seen in step 410, braid 10 begins expanding and/or inverting as its distal implant end 16 moves away from distal end 26 of catheter 20 and/or delivery end 46 (not identified in this figure) of delivery tube 34 to form sack 12 within aneurysm A being treated (see, e.g., formed sack 12 of device 1 that occludes aneurysm A of FIG. 1).

[0083] In certain embodiments, sack 12 begins being formed as braid 10 is advanced to the vicinity of the neck or dome of the aneurysm such that mechanism 38, attachment 36, and/or portions of delivery tube 34 are at the level of the neck as seen under fluoroscopy. However, device 1 is not so limited and instead braid 10 can begin inverting and folding into itself to form sack 12 as distal implant end 16 simply distally slides away from delivery tube 34 and/or catheter 20. As shown in step 415, sack 12 is now taking a generally spherical shape as braid 10 is translated distally deeper into aneurysm A and/or further away from catheter 20 and tube 34. In moving between steps 405 to 415, the outer diameter of the braid 10 radially expands to a diameter greater than the microcatheter 20 as sack 12 is formed. The braid wire count of interstices of braid 10 that may form the outer surface can vary depending of the diameter of the sack 12 or sacks needed to occlude the aneurysm. For example, in order to induce formation of the predetermined shape and strength of sack 12, distal implant end 16 of braid 10 may be more pliable than proximal implant end 14 and portions of braid 10 may vary from most pliable on or about end 16 and less pliable on or about end 14. Interstices of braid 10 may also form openings for occlusion of the aneurysm.

[0084] Such distal movement of mechanism 38 and initial formation of sack 12 of braid 10 is more clearly shown in FIG. 5A which is an enlarged view of section B-B of FIG. 4. As distal implant end 16 of braid 10 distally translates toward aneurysm A and away from end 26 of microcatheter 20, the distal implant end 16 of braid 10 can begin to invert and fold into itself thereby beginning to form an occlusive sack 12 for occluding an aneurysm. This is more clearly shown in FIG. 5B, which is an enlarged view of section C-C of FIG. 4. Mechanism 38 may be driven by a hypotube from its proximal end by an operator or the like. It is understood that braid 10 can also be attached to and/or foldable over an inner portion of mechanism 38, for example at attachment 36.

[0085] In step 420, mechanism 38 may continue to be distally translated while distal implant end 16 of braid 10 continues inverting as it approaches or contacts the dome of aneurysm A. Braid 10 can also begin inverting immediately as it exits catheter 20 (see, e.g., step 410 of FIG. 5A). It can be seen that sack 12 has now completely expanded into its predetermined, spherical shape designed to conform to the shape of aneurysm A. This is more clearly shown in FIG. 5C which is an enlarged view of section D-D, wherein sack 12 can be seen in the spherical shape. More specifically, in moving between steps 405 and 420 as shown between FIGS. 5A-5C, mechanism 38 distally translates braid 10 until braid folds about its distal implant end 16 to form the sack 12. Sack 12 may take on any shape necessary to occlude the respective aneurysm A.

[0086] Between steps 420 to 425, mechanism 38 continues to distally slide until unexpanded, braid portion(s) 17 proximal of sack 12 folds and randomly fills sack 12, as shown more particularly in FIG. 5D, which is an enlarged view of section E-E. Sack 12 can be the depicted spherical shape and formed to impart a predetermined packing density and portion 17 which is formed with braid 10 has filled sack 12 to further reinforce sack 12. In other words, as the braid 10 reaches the dome of the aneurysm, the braid portion(s) 17 proximal to sack 12 coming from mechanism 38 can be forced to deflect and start filling the sack 12 as shown starting in step 415.

[0087] In step 430, with the sack 12 fully formed in a manner sufficient to occlude aneurysm A, braid 10 can be detached from attachment 36. However, if sack 12 is not precisely positioned or if needs to be reset within aneurysm A for safe occlusion without risk of rupture, braid 10, including sack 12, can be retracted back into delivery tube 34 by proximally moving mechanism 38. It is understood that when sack 12 is fully formed, it is capable of packing aneurysm A with a 15-25% packing density without the need for any embolic coils. However, braid 10 can be designed to achieve a packing density of 40%, 50%, or less than 15-25%, as needed or required. The change in packing density can be affected by changing the length or diameter of the braid 10. A longer or shorter braid 10 in the same aneurysm A can change the amount of braid deployed, which in turn can dictate the number of sacks 12 formed and the amount of unexpanded, braid portion 17 filling the sack 12. The same can hold true for the diameter of the braid 10, a larger diameter filling more of the aneurysm A in less length, but at a lower density. The operator can then choose between the differing parameters of a braid 10 for each particular aneurysm A.

[0088] In step 435, because sack 12 has been properly positioned and formed within aneurysm A, braid 10 has been detached from mechanism 38 and mechanism 38 can now be retracted therefrom. As shown, opposing grasper arms 42a, 42b can be formed with the microcatheter 20 or delivery tube 34 and withdrawn proximally so arms 42a, 42b can release sack 12 formed by expanding braid 10. It is understood that some or all of arms 42a, 42b can be radiopaque so that positioning and detachment can be monitored and/or driven under fluoroscopy.

[0089] One example of attachment 36 is shown in FIG. 6A which is an enlarged perspective schematic view of section E-E of step 425 across center line in order to show braid 10 in communication with mechanism 38. It can be seen that mechanism 38 may include a pull wire 39 that hooks into or attaches to braid 10 and similarly can be released therefrom and that attachment will be secure so long as pull wire 39 is not pulled proximally. If pull wire 39 is pulled back braid 10 can be released. FIG. 6A is merely one way that mechanism 38 may attach to braid 10 across attachment 36 and any number of attachment means are contemplated as needed or required.

[0090] Another example of how system 30 may release braid 10 is shown in FIG. 6B. In a first step 605B of method 600B, mechanism 38′ is shown in a collapsed condition within delivery tube 34′ and catheter 20. Mechanism 38′ includes a substantially elongate portion 37′ that generally runs along the inner cavity or lumen of tube 34′ leaving a space between the elongate portion 37′ and the tube 34′. Portion 37′ may be axially aligned with tube 34′. A base portion 33′ of mechanism 38′ may also be included disposed on a proximal end of mechanism 38′. Portion 33′ may at least be wider than portion 37′ and can extend to the inner surface of tube 34′. During use, braid 10 can be axially positioned over the space between portion 37′ and tube 34′, advanced over portion 37′, and secured to portion 33′. In step 610B, it can be seen that mechanism 38′ has been distally translated so that portion 37′ is now distal of tube 34′ and catheter 20. Base 33′ has similarly been distally translated until it contacts protrusions 41′ of tube 34′. When base 33′ contacts protrusion 41′ in step 610B, protrusion 41′ will be distal of tube 34′ so that proximal implant end 14 of braid 10 is free to detach. Protrusion 41′ may also include a gap or space 43′ into which end 14 of braid 10 can be attached. When space 43′ is distal of catheter 20 and tube 34′, in those embodiments where end 14 was previously fastened at space 43′, end 14 may now freely disengage and release.

[0091] Protrusions 41′ may be members or extensions of tube 34′ that inwardly protrude to reduce the inner diameter thereabout to be less than a diameter of base 33′. In this regard, only one protrusion 41′ may be provided integrally formed with tube 34′ or detachably connected and positioned therewith. However, method 600B is not so limited and more than one protrusion 41′ can be provided as well as a cylindrical protrusion 41′, or any other protrusion shaped and designed to reduce the inner diameter to prevent base 33′ from moving passed.

[0092] Another example of how system 30 may release braid 10 is shown in FIG. 6C-FIG. 6F. In FIG. 6C, a schematic is shown of an exemplary prototype. FIG. 6D is a photograph of an exemplary prototype exemplifying the embodiment shown in FIG. 6C. Braid 10 is depicted in both FIGS. 6C and 6D in a deployed condition wherein sack 12 is formed distal of catheter 20 and tube 34″. Mechanism 38″ in this embodiment is mechanically attached to braid 10 via attachment 36″, as more clearly shown in FIGS. 6E and 6F. Specifically, in FIG. 6E, catheter 20 has been removed to show braid 10 interconnected with mechanism 38″ at attachment 36″. In FIG. 6F., mechanism 38″ has been detached from braid 10. In practice, mechanism 38″ and catheter 20 can now be removed from the vasculature and from the patient altogether leaving occlusive sack 12 selectively positioned and formed to occlude aneurysm A.

[0093] Attachment 36″ is more clearly shown in FIG. 7 which is an enlarged perspective schematic view of section G-G of FIG. 6E showing end 14 of braid 10 in communication with mechanism 38″. It can be seen that mechanism 38″ may include a releasable attachment interface formed by an interlinking member 39″ about its distal end 46. Member 39″ may be integrally formed with mechanism 38″ and be constructed from a recess or channel portion operable to securely engage with attachment portion 11 of braid 10. Portion 11 may in turn be a separate portion fastened to, formed with, or otherwise disposed on end 14 of braid 10. Portion 11 may include a corresponding channel or recess operable to detachably, securely engage with member 39″. In practice, member 39″ may be securely engaged with portion 11 within delivery tube 34 prior to delivery to the vasculature. However, the mechanism 38″ and braid 10 are not so limited and engagement can occur contemporaneous with delivery of system 30 being delivered to the vasculature. When the operator desires to deliver and release sack 12 with aneurysm A, braid 10 may be advanced distally from catheter 20 and/or delivery tube 34 by moving mechanism 38″. Once member 39″ is distal of tube 34, corresponding portion 11 of braid 10 can be released therefrom. Mechanism 38″ can then be retracted and system 30 can be removed from the location of interest in the vasculature. It is understood that FIG. 7 is merely one way that a pushing mechanism of the herein disclosed system 30 may attach and detach to end 14 of braid 10 across attachment 36″ and any number of attachment means are contemplated as needed or required.

[0094] FIG. 8 is a schematic side view of another example delivery system 30 with device 1 in the process of being deployed and sack 12 in the process of being formed. In this embodiment, a coil 33 is also assembled with the delivery system 30 for later filling sack 12 to further facilitate packing of aneurysm A. It is understood that one or more additional coils can be inserted with proximal implant end 14 as needed or required. System 30 is not so limited, however, and braid 10 can include portions behind sack 12 that do not invert to form a sack. Instead, these aft portions are capable of being slid distally into formed sack 12 similar to adjusting a packing density delivered by sack 12 (see, e.g., FIGS. 12A-12I).

[0095] FIG. 9 is a flow diagram for a method 900 of delivering an occlusion device. In step 905, a self-expanding braid inverts as it distally translates from a delivery catheter into the aneurysm. In step 910, the braid forms an occlusive sack that conforms to the size and/or shape of the aneurysm. The braid may invert and/or radially expand in step 910 to form the occlusive sack. In step 915, the braid continues distally translating and when the braid reaches the top of the aneurysm, portions of the braid cease inverting (e.g., portions of the braid proximal the occlusive sack) and are in a non-inverted condition. In some embodiments, portions of the braid proximal the occlusive sack are in a non-inverted condition (e.g., unexpanded) as the braid is distally translated deeper into the aneurysm. In step 920, the portions of the braid in the non-inverted condition distally translate and fill the occlusive sack inside the aneurysm to a predetermined packing density. The density can be increased at least 25%, between 25-50%, or as much as 75% more than existing coil approaches.

[0096] FIG. 10 is a flow diagram for a method 1000 of delivering an occlusion device using the herein disclosed delivery system. Step 1005 includes selectively positioning a microcatheter in the vasculature. Step 1010 includes slidably positioning a delivery system of the occlusion device within the microcatheter, the delivery system comprising a delivery tube comprising a distal end and a proximal end and a pushing mechanism slidably disposed within the delivery tube, the pushing mechanism comprising a distal end and a proximal end. Step 1015 includes slidably positioning a self-expanding braid of the occlusion device within the delivery tube, the braid comprising a distal end and a proximal end. Step 1020 includes detachably attaching the proximal end of the braid to the distal end of the pushing mechanism. Step 1025 includes advancing the delivery system to the vasculature to the aneurysm. Step 1030 includes distally sliding the braid, by the pushing mechanism, in the delivery tube toward the aneurysm thereby causing the braid to invert and/or radially expand whiling moving from a collapsed condition within the delivery tube to a deployed condition within the aneurysm as the distal end of the braid is moved outside and away from the distal end of the delivery tube. Step 1035 includes releasing the occlusion device and withdrawing the delivery system and the catheter from the patient.

[0097] FIGS. 11A and 11B illustrate an example of the braid, or braided mesh 100. The mesh 100 can be self-expanding and which can be comprised of a tube of mesh. The self-expanding mesh 100 can include multiple wires 102, for example from 4 to 96 wires. The number of wires 102, and the diameter of the wires can be a factor in controlling the stiffness and pore size. y. For example, the distal end of the braid can more porous or more flexible than the proximal end, or vice versa. The combination of a braid with only one sack or multiple sacks (e.g., two or more sacks) can be taken into account when determining the number of wires. Fewer wires 102 can be used as a whole and still result in desired occlusion. The wires 102 can be made from multiple alloys such as a nickel-titanium alloy, cobalt chromium alloys, Platinum, Nitinol, Stainless Steel, Tantalum, or other alloys, or any other suitable biocompatible materials, or combination of these materials, including deposited thin films. Also, these materials can be absorbable or non-absorbable by the patient over time.

[0098] The apertures 104 in the mesh 100 create a substantially unitary frame work or mesh in the wall 106. Thus, the apertures 104 may be of any size, shape, or porosity, and may be uniformly or randomly spaced throughout the wall 106 of the mesh 100. The apertures 104 provide the tubular element with flexibility and also assist in the transformation of the mesh 100 from the collapsed state to the expanded state, and vice versa.

[0099] As discussed above, the mesh 100 inverts as it forms. This means that the inside 108 of the mesh 100 when the mesh is formed, becomes the “outside” on deployment or is in contact with the aneurysm A wall, as illustrated in FIG. 11B. For clarity, the mesh 100, is initially formed as a hollow cylindrical shape. This shape has an inside 108 and an outside. The inside 108 being akin to the hollow portion of a tube. Upon deployment, the mesh 100 is turned inside-out so the “inside” 108 on formation is now the “outside” of the sack 112 once deployed in the aneurysm A.

[0100] Note that the mesh 100 has a length L and that length L forms both the sack 112 and the unexpanded mesh 110 (or “tail”) that forms within the sack 112. Controlling the length L can provide differing diameters of the sack 112, the number of internal sacks and/or the length of the tail 110 that fills the sack 112 and affects packing density.

[0101] In one example, the inversion of the mesh 100 can be formed when the proximal end 114 of the mesh 100 is pushed forward while the distal end 116 remains fixed. The proximal end 114 is pushed inside 108 forcing the proximal end 114 to exit the delivery tube first while end 116 remains fixed. Once the entire length L is deployed out of the delivery tube, the distal end 116 is detached and is thus the last end to be deployed. As above, the proximal end 114 engages the proximal implant end 14 and the distal end 116 engages the distal implant end 16. The mesh 100 can be formed akin to a tube sock.

[0102] Another example fixes the distal end 116 as above, and as the proximal end 114 is pushed, the mesh 110 just behind the distal end 116 is deployed, still causing the mesh 100 to deploy “inside out.” Here, once the mesh 100 is fully deployed, both the proximal and distal ends 114, 116 are next to each other.

[0103] FIG. 11C illustrates the mesh 100 post-deployment with an embolic coil 330 at the proximal end 114 which can be opened. With end 114 being opened, the embolic coil 330 may be inserted therethrough to increase packing density of the corresponding occlusive sack or otherwise support the occlusive sack in certain aneurysm morphologies, such as aneurysms with wide necks. Coil 330 be made with any biocompatible materials commonly used in the art such as nickel-titanium alloy, cobalt chromium alloys, Platinum, Nitinol, Stainless Steel, Tantalum, or other alloys; or any other suitable biocompatible materials, or combination of these materials. The stiffness of the coil 330 can be adjusted by, for example, typical coil parameters of coil wire diameter, coil wound diameter, coil pitch, and coil material. In the instance of a coil, the diameter of the coil is selected in consideration of the size and shape of the aneurismal sac A, which can be a variety of shapes and sizes.

[0104] FIGS. 12A-12I depict example embodiments of braid 10 being delivered to an example aneurysm A. Specifically, in FIG. 12A, braid 10 can be seen being initially advance into aneurysm A and sack 12 beginning to take shape. In FIG. 12B, it can be seen that braid 10 continues to be distally advanced toward dome D of aneurysm A and folds into itself to form sack 12. However, braid 10 is not so limited and in certain embodiments as braid 10 exits catheter 20, braid 10 can begin inverting to form sack 12 without a break 13 and independent of its position relative to dome D. “The term “break” is used herein to include a region of the braid that facilitates inversion and/or avoid kinking of the braid during delivery. The break can include one or more local changes in physical properties with respect to other regions of the braid (e.g., increased flexibility, pre-weakened, etc.). Sack 12 is radially expanding toward the walls of aneurysm A while unexpanded portions 17 of braid 10 continue to be translated. It is understood that break 13 may be formed into the interstices of braid 10 so that inverted, folding occurs after braid 10 has distally translated a predetermined distance. Break 13 may include localized heat treatment to render braid 10 more ductile but kink 243382.000323 DSP5326USCNT2 preventative and induce a gradual folding curve. In this respect, the break 13, including localized heat treatment, can render braid 10 capable of expanding after inverting. Break 13 may also be simply be a weak point or buckling point pre-set for a particular sack 12 so that buckling is induced so as to avoid strain of aneurysm A. Alternatively, no break 13 may be included and instead braid 10 may invert and fold into itself upon contacting the dome D of aneurism A based on pre-selected pliability of braid 10.

[0105] In certain embodiments, sack 12 can be sized for only a specific sized aneurysm A. However, in other embodiments, sack 12 can be conformable or adjusted by the operator to sufficiently pack aneurysms across multiple sizes (e.g. across approximately 6 mm to approximately 10 mm) by continuing to advance portion 17 so that sack 12 is adjusted, as needed. For example, translating portion 17 distally from first to second positions can adjust from a first occlusion setting to a second setting. This is particularly advantageous in a clinical setting since it means that accurate measuring of aneurysm A is unnecessary and instead, sack 12 can be precisely and safely adjusted to fit aneurysm A in a manner that occludes without risk of rupture.

[0106] In FIG. 12C, sack 12 is nearly fully formed and in FIG. 12D, portions 17 have been distally translated so that sack 12 is fully formed with no additionally portions necessary to expand. In FIG. 12D specifically, it can be seen that formed sack 12 is now adjacent and supporting dome D. Braid 10 meanwhile may continue to be translated to form one or more additional sacks internal to sack 12 in order to overlay sack 12 to decrease porosity and/or further slow flow into the aneurysm. For example, in FIG. 12E, a second break may be included in braid 10 so that as portion 17 continues to be translated distally, a second sack 15 can begin to form and invert into itself. In FIG. 12F, portion 17 has distally translated more so that second sack 15 is now fully formed and overlaid internal to sack 12. In FIGS. 12G-12I, after formation of sacks 12, 15, portion 17 may continue to be distally translated while other portions of braid 10 no longer invert. In this respect, portion 17 can be considered a non-inverted portion of braid 10 proximal of sacks 12, 15. Portion 17 distally translates to fill sack 15 with portions 17, similar to a coil approach. However, unlike a coil approach, portions 17 can both fill sacks 12, 15 and then be retracted therefrom if an operator desires to re-position or re-set braid 10 with aneurysm A. The packing density of sack 12 can be adjusted by distally or proximally advancing portions 17 between one or more predetermined (e.g. a first setting of 15%, a second setting of 20%, a third setting of 25% etc). Rates of fluid occlusion can also be optimized by varying porosity throughout braid 10, including ends 14, 16, portion 17, and/or sacks 12, 15. The depicted embodiments here are merely example approaches of the herein disclosed braid 10. Other embodiments could include only one occlusive sack or more than two example occlusive sacks as depicted.

[0107] It is understood that variations of the braid 10 can include various materials such as stainless steel, bio absorbable materials, and polymers. Braid 10, including any specific portions such as any breaks and corresponding sacks, can be heat set to various configurations such as spherical, oblong, saddle shaped, etc. for the purpose of shaping the initial sack to better match the aneurysm morphology. In addition, the braid 10 can be heat shaped to include weak points to facility the braid buckling once it reaches the dome of the aneurysm.

[0108] It is also understood that any sack formed by the herein discussed braids 10 can be in a spherical shape as depicted or any other shape, as needed or required, such as ellipsoidal, heart-shaped, ovoid, cylindrical, hemispherical, or the like. Further, interstices of braid 10 that form the sack can vary, or be selectively designed, in size or shape along its length depending on how much braid 10 is caused to radially expand as pushing mechanism 38 is distally moved.

[0109] The specific configurations, choice of materials and the size and shape of various elements can be varied according to particular design specifications or constraints requiring a system or method constructed according to the principles of the disclosed technology. Such changes are intended to be embraced within the scope of the disclosed technology. The presently disclosed embodiments, therefore, are considered in all respects to be illustrative and not restrictive. It will therefore be apparent from the foregoing that while particular forms of the disclosure have been illustrated and described, various modifications can be made without departing from the spirit and scope of the disclosure and all changes that come within the meaning and range of equivalents thereof are intended to be embraced therein.

ASPECTS OF THE INVENTION

[0110] 1. A vaso-occlusive device having a delivery configuration when restrained within a delivery catheter and a deployed configuration when released from the delivery catheter into an aneurysmal sac, the vaso-occlusive device comprising: [0111] a tubular structure, comprising: [0112] a distal portion configured to form a first sack within the aneurysmal sac when distally deployed from the delivery catheter into the aneurysmal sac, [0113] a proximal portion configured to form a second sack within the first sack when distally deployed from the delivery catheter, thereby creating multi-layer [0114] scaffolding within the aneurysmal sac; and [0115] an elongate embolic element coupled to proximal end of the tubular structure,
wherein the elongate embolic element is configured to fill an interior region of the multi-layer scaffolding when distally deployed from the delivery catheter into the aneurysmal sac. [0116] 2. The vaso-occlusive device of aspect 1, wherein the tubular structure comprises a tubular braided mesh. [0117] 3. The vaso-occlusive device of aspect 1 or 2, wherein the elongate embolic element comprises a braided ribbon. [0118] 4. The vaso-occlusive device of any preceding aspect, wherein the elongate embolic element comprises an embolic coil. [0119] 5. The vaso-occlusive device of any preceding aspect, wherein at least one of the distal portion and the proximal portion is configured to invert upon movement of the vaso-occlusive device from the delivery configuration to the deployed configuration. [0120] 6. The vaso-occlusive device of aspect 5, wherein the tubular structure further comprises an inflection region between the distal portion and the proximal portion, the inflection region configured to urge the inversion of the proximal portion and/or urge the inversion of the distal portion. [0121] 7. The vaso-occlusive device of aspect 6, wherein the inflection region is configured for urging the inversion of the proximal portion and/or the distal portion while the vaso-occlusion device moves from the delivery configuration to the deployed configuration in free-space. [0122] 8. The vaso-occlusive device of any preceding aspect, wherein each of the distal portion and the proximal portion is configured for self-expanding into a spherical, oblong, or saddle shape. [0123] 9. The vaso-occlusive device of any preceding aspect, wherein the distal portion comprises a non-expanding terminal end. [0124] 10. An implant configured to traverse vasculature within a delivery catheter and move from a delivery configuration with restrained by the delivery catheter to a deployed configuration within a spherical cavity, the implant comprising: [0125] an expandable tubular braid comprising a first portion configured to form a first sack conformal to walls of the spherical cavity and a second portion configured to form a second sack within the first sack when the implant moves from the delivery configuration to the deployed configuration; and [0126] an elongate embolic element coupled to the tubular braid and configured to be positioned within the first sack and the second sack when the implant moves from the delivery configuration to the deployed configuration. [0127] 11. The implant having aspect 10, wherein the elongate embolic element comprises a braided ribbon. [0128] 12. The implant of aspect 10 or 11, wherein the elongate embolic element comprises an embolic coil. [0129] 13. The implant of any of aspects 10 through 12, wherein at least one of the first portion and the second portion is configured to invert upon movement of the implant from the delivery configuration to the deployed configuration. [0130] 14. A method of treating an aneurysm in a patient, the method comprising: [0131] distally advancing a vaso-occlusive device in a delivery configuration through a delivery catheter to an aneurysm neck, the vaso-occlusive device comprising a tubular structure and an elongated embolic element coupled to a proximal end of the tubular structure; [0132] deploying a distal portion of the tubular structure from a distal end of the delivery catheter into a sac of the aneurysm; [0133] expanding the distal portion of the tubular structure, thereby creating a single-layer scaffolding that lines a wall of the aneurysm sac; [0134] deploying a proximal portion of the tubular structure from the distal end of the delivery catheter; [0135] expanding the proximal portion of the tubular structure within the expanded distal portion of the tubular structure, thereby creating a multi-layer scaffolding that lines the wall of the aneurysm sac; and [0136] positioning the elongated embolic element within the multi-layer scaffolding. [0137] 15. The method of aspect 14, wherein the tubular structure comprises a tubular braided mesh. [0138] 16. The method of aspect 14 or 15, wherein the elongate embolic element comprises an embolization coil and/or a braided ribbon. [0139] 17. The method of any of aspects 14 through 16 further comprising: [0140] inverting at least of the distal portion and the proximal portion upon deployment of the tubular structure from the distal end of the delivery catheter. [0141] 18. The method of aspect 17, wherein the tubular structure further comprises an inflection region between the distal portion and the proximal portion, the inflection region configured to urge the inversion of the proximal portion and/or urge the inversion of the distal portion. [0142] 19. The method of aspect 18, wherein inversion of the tubular structure at the inflection region is initiated absent an application of an opposing proximal force on the tubular structure by a dome of the aneurysmal sac.
20. The method of any of aspects 14 through 19, further comprising: [0143] expanding each of the distal portion and the proximal portion respectively into a spherical, oblong, or saddle shape.