WO2004016150A2

WO2004016150A2 - Aneurysm stent

Info

Publication number: WO2004016150A2
Application number: PCT/US2003/025430
Authority: WO
Inventors: Jeffrey M. D. Thramann; Michael M. D. Fulton
Original assignee: Thramann Jeffrey M D
Priority date: 2002-08-19
Filing date: 2003-08-15
Publication date: 2004-02-26
Also published as: AU2003259830A8; US7241301B2; AU2003259830A1; WO2005037129A2; WO2005037129A3; US20070225794A1; WO2004016150A3; US20040034386A1; US20040106945A1; US7621928B2

Abstract

The present invention relates to an aneurysm stent having a base and connector. The base has a vessel facing side and an aneurysm facing side, and is shaped to cover an aneurysm sufficiently. The connector is coupled to the aneurysm facing side of the base such that when deployed the connector is adapted to extend partially into the aneurysm to anchor the base about the aneurysm and inhibit flow into the aneurysm.

Description

ANEURYSM STENT The present invention claims the benefit of United States Provisional Application Serial Number 60/404,422, filed August 19, 2002, titled CEREBRAL ANEURYSM COIL STENT, incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to the surgical repair of aneurysms and, more particularly, to a patch that provides a seal between the arterial wall and a neck of the aneurysm to inhibit flow in the aneurysm.

BACKGROUND OF THE INVENTION An aneurysm is a blood-filled dilation of a blood vessel. Major concerns with aneurysms revolve around rupturing of the arterial wall causing internal bleeding and clots breaking away from the aneurysm causing strokes.

There exist two generally approved methods of treating aneurysms. The first method of treatment includes surgical treatment. The second method of treatment includes endovascular treatment. Surgical removal of the aneurysm is sometimes not possible, leaving endovascular treatment as the only available option. Even when not the only option, endovascular treatment often is preferred because of the reduced risks and complications.

Conventionally, endovascular treatment of an aneurysm involves "packing" the aneurysm such that an endovascular occlusion is formed. Packing the aneurysm with coils, such as Guglielmi Detachable Coils (or GDCs), helps form an occlusion. While using GDCs is conventional, the aneurysm can be packed with numerous devices, such as, for example, other types of coils, balloons, glues, polymers, clotting agents, liners, or the like. Endovascular treatment, while considered less risky than surgical treatment, has drawbacks. One drawback of endovascular treatment of the aneurysm includes the potential to over pack the aneurysm. Over packing the aneurysm can cause the material to enter the parent blood vessel, potentially inhibiting blood flow or generate undesirable pressure in the aneurysm. Also, some aneurysms have a wide connection to the blood vessel, a.k.a. wide neck aneurysms. Wide neck aneurysms have the additional risk that the occluded material will break free of the aneurysm and enter the parent blood vessel, potentially causing blockage of the parent blood vessel. Finally, clotting agents and polymers used to form occlusions in the aneurysm can seep to the parent blood vessel causing complications. Balloons and liners are intuitively pleasing as a solution, but have the potential for an inexact fit causing complications. For example, a balloon may be over inflated causing unwanted pressure or under inflated causing seepage in the aneurysm.

While the packing methods described above inhibit blood flow to the aneurysm, the aneurysm neck typically is open to the parent blood vessel. Thus, blood continues to flow to the aneurysm. To reduce the blood flow, several devices have been developed to cover the neck area of the aneurysm. United States Patent No. 6,454,780, issued September 24, 2002, to

Wallace, titled Aneurysm Neck Obstruction Device, shows a device designed to cover or block the neck of the aneurysm. FIG. 1 shows the Wallace device 10 in some detail. The device 10 is placed inside aneurysm 50 using a catheter 46 and deployment tool 44. When inside the aneurysm 50, device 10 has walls 12 that expand or unfold to contact the inside of the aneurysm 50 and block neck 51. But the device resides internal to aneurysm 50 allowing blood flow shown by arrow A in the parent vessel 52 to push up against the walls 12. The upward pressure of the blood vessel on the wall 12 may allow blood from the parent vessel to seep in aneurysm 50. Also, because the wall is internal to the aneurysm 50, the neck 12 has the potential to expand. Other types of internal devices include liners and other neck bridges.

Devices to block the neck of the aneurysm external to the aneurysm exist also. These devices use the pressure of the blood vessel to help seat the block against the parent vessel wall and shield the neck from the blood vessel. One such device is shown in United States Patent No. 6,309,367, issued October 30, 2001, to Boock, titled Aneurysm Shield. The Boock device is shown in FIG. 2. The Boock device 30 has a cylindrical shaft 32 that covers the neck 37 of the aneurysm 38 and is anchored by anchor rings 34 and 36. While device 30 resides external to the aneurysm it has multiple parts that could break free or deteriorate that reside in the parent vessel. While the Boock device 30 seemingly works for its intended purpose in theory, its relatively large size and surface area makes its impractical to actually use. In the brain, for example, multiple blood vessels may branch off from the location of an aneurysm. Attempting to use the Boock device would block blood flow to one or more of the branch vessels as well as the aneurysm, which makes the Boock device useful in only limited situations, if any. Thus, it would be desirous to develop and improve internal and external aneurysm stents.

SUMMARY OF THE INVENTION

To attain the advantages and in accordance with the purpose of the invention, as embodied and broadly described herein, apparatuses to inhibit the flow of blood to an aneurysm comprise a base and connector. The base has a vessel facing side and an aneurysm facing side, and is shaped to cover an aneurysm sufficiently. The connector is coupled to the aneurysm facing side of the base such that when deployed the connector is adapted to extend partially into the aneurysm to anchor the base about the aneurysm and inhibit flow into the aneurysm.

The foregoing and other features, utilities and advantages of the invention will be apparent from the following more particular description of a preferred embodiment of the invention as illustrated in the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWING

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention, and together with the description, serve to explain the principles thereof. Like items in the drawings are referred to using the same numerical reference.

FIG. 1 shows a prior art aneurysm device;

FIG. 2 shows a prior art aneurysm device; FIG. 3 shows a perspective view of an aneurysm stent deployed in a blood vessel illustrative of the present invention;

FIG. 4 shows a cross section of a blood vessel with an aneurysm prior to deployment of the aneurysm stent illustrated in FIG. 3;

FIG. 5 shows a cross section of the aneurysm stent just prior to deployment;

FIG. 6 shows a cross section of the aneurysm stent mostly deployed about the aneurysm;

FIG. 7 shows a cross section of the aneurysm stent deployed;

FIG. 8 shows a cross section of a portion of a stent consistent with the present invention;

FIGS. 9A and 9B show a stent consistent with the present invention; and

FIGS. 10A and 10B show a cross-section of a stent consistent with the present invention.

DETAILED DESCRIPTION

Some embodiments of the present invention are described with reference to FIGS. 3 to 10B. FIG. 3 shows an aneurysm stent 300 consistent with an embodiment of the present invention deployed. Stent 300 is deployed in a parent blood vessel 302, which is shown as an artery but could be a vein a capillary, or the like, about aneurysm 304. A blood flow path from vessel 302 to aneurysm 304 is provided by an aneurysm neck 306. Neck 306 is shown as a narrow neck, but could be a wide neck. Aneurysm 304 is shown packed with conventional GDCs 308. While shown as packed with conventional coils, aneurysm 304 could be packed with any type of packing agent, such as, for example, other types of coils, balloons, glues, polymers, clotting agents, liners, or the like. In fact, aneurysm 304 does not need to be packed at all as stent 300 blocks blood flow to aneurysm 304. The attachment of stent 300 to cover neck 306 will depend, in part, on the type of material used to pack aneurysm 304, if any. With reference to FIG. 3, which illustrates aneurysm 304 packed with conventional GDCs 308, stent 300 includes a base 310, a base connection point 312, and a connector 314. Base 310 has opposed sides, a vessel side and a wall side (not specifically labeled). The vessel side can be covered with a graft material or other biocompatible material. The vessel side may be coated with a material to stimulate cell growth and encourage formation of a pseudointima. The wall side could be covered with an adhesive to assist in seating stent 300 about neck 306 by forming a seal between base 310 and vessel 302. Base connection point 312 couples base 310 to connector 314. Base connection point 312 does not need to exist as a separate component, but is identified for convenience to distinguish between base 310 and connector 314. Base connection point 312 could, as a matter of design choice, be a fitting to connect base 310 and connector 314 if desired. Connector 314 can be a conventional coil material attached to base 312 that extends to GDCs 308. When deployed, connector 314 assumes its coiled shape and engages GDCs 308 to assist in keeping stent 300 seated about neck 306. Connector 314 could physically curl around or hook into GDCs 308 for anchoring, but connector 314 could simply pack in aneurysm 304 similar to a conventional GDC. Connector 314 could simply anchor stent 300 in place, but could also contract and pull base 310 snug against vessel 302 to firmly seat base 310 about aneurysm neck 306 further inhibiting blood flow to aneurysm 304.

While only one base connection point 312 and one connector 314 is shown in FIG. 3, multiple connections and connectors are possible. Also, the connections do not necessarily have to be in the center of the stent, but could be offset. It is believed greater stability will be obtained by symmetrical placement of connectors and connection points, but asymmetrical placement is possible. Multiple connectors could be attached to a single connection point as well.

Referring now to FIGS. 4-7, a method of deploying the stent 300 will be described. Referring first to FIG. 4, parent vessel 302 is shown with aneurysm 304 and neck 306 existing off the main body of vessel 302. Unlike FIG. 3, a second vessel 402 resides about neck 306 forming a junction 404. While the present invention will be explained in connection with deploying stent 300 about junction 404, stent 300 could be similarly deployed at locations with more or less junctions. First, aneurysm 304 is packed using, for example, conventional GDCs 308 in a conventional manner. Without going in much detail, GDCs 308 are placed by first directing a catheter 406 to the site of aneurysm 304. GDCs 308 are passed through catheter 406 and packed in aneurysm 304 in a conventional manner. Once GDCs 308 are placed, stent 300 is passed through the same or a different catheter 406 using a guide wire 502 (FIG. 5). Stent 300 includes base 310 and connector 314. As can be seen, base 310 is compacted to pass through catheter 406. Also, connector 314 enters the packed GDCs 308.

Referring now to FIG. 5, stent 300 has exited catheter 406 and guide wire 502 can be seen attached to stent 300. Base 310 is approaching neck 306 and connector 314 has extended in GDCs 308 packed in aneurysm 304. As shown, base 310 can be made of a self- expanding material that begins expanding on exiting catheter 406. Alternatively, base 310 can be made of a material that requires activation or other manipulation to expand.

Referring now to FIG. 6, stent 300 is shown in the appropriate position and guide wire 502 has been withdrawn. Base 310 has expanded sufficiently to mostly block neck 306 and connector 314 has begun curling, packing, embedding or otherwise anchoring in aneurysm. For example, connector 314 can be placed about GDCs 308 as conventional packing material, connector 314 can curl and engage GDCs 308, or the like. While one connector 314 is shown, it would be possible to have two of more connectors 314. As described in more detail below, a number of other devices and techniques can be used to anchor stent 300 about the neck.

Referring now to FIG. 7, stent 300 is shown with base 310 and connector coils 314 fully deployed. In this case, base 310 is flush with the wall of vessel 302, wraps around junction 404 and is flush with the wall of vessel 402. Connectors 314 are engaged with GDCs 308 and, optionally, connectors 314 contract in a manner that pulls base 310 in toward GDCs 308 providing a snug seating between base 310 and vessel 302.

The stent 300 could be made of many materials. Some material includes conventional graft material. Alternatively, stent 300 could be made of one or more shaped memory alloys (SMAs) or a combination of graft material and SMAs. SMAs are a group of materials that demonstrate an ability to return to some previously defined shape or size when subjected to the appropriate thermal procedure. Generally, these materials can be plastically deformed and, upon exposure to thermal manipulation, will return to the pre-deformation shape. Some SMA material is considered to be two- way shaped memory alloys because they will return to the deformed shape upon proper thermal activation. SMAs include Ag-Cd alloys, Cu-Al-Ni alloys, Cu-Sn alloys, Cu-Zn alloys, Cu-Zn-Si alloys, Cu-Zn-Sn alloys, Cu-Zn- Al alloys, In-Ti alloys, Ni-Al alloys, Ni-Ti alloys, Fe-Pt alloys, Mn-Cu alloys, Fe-Mn-Si alloys, and the like. As shown by FIGs. 4-7, SMAs would work well for stent 300 because, for example, connectors 314 could be shaped with a predefined curl that will engage GDCs 308. The SMA could be deformed at a predefined temperature to a straight, or substantially straight, shape to allow for connectors 314 to penetrate packed GDCs 308 in aneurysm 302. Thermal manipulation would cause connector coils 314 to assume the original curled shape that will anchor stent 300 about aneurysm 302 and may provide a force tending to pull base 310 in towards aneurysm 302 further seating stent 300 about aneurysm 302. Similarly, base 310 could be made of SMA. In this case, base 310 could be originally shaped to approximate the shape of the vessel(s) around aneurysm neck 304 to allow for as close a fit as possible. This would also allow use of stent 300 in areas having many vessels branching around the aneurysm.

As shown in FIGS. 3-7, base 310 is shown having a circular or semicircular shape. In particular, FIG. 3 illustrates base 310 as a coil of material that expands on deployment. The shape of base 310, however, is largely a function of material, design choice, and the aneurysm location. Thus, stent 300 could take many shapes including triangular, rectangular, square, elliptical, conical, spherical, circular, cylindrical, or the like

The present invention has been described with the aneurysm packed with conventional GDC coils, as described above, the aneurysm could be packed with alternative material. For example, if the aneurysm was packed with a polymer or clotting agent, the connector or anchor could be a simple post connected to the stent and embedded in the occlusion. Base 310 connected to the post would be held in place by the occlusion. Further seating force could be supplied by using a material that contracts on activation, such as SMAs. If the aneurysm was packed with a liner or balloon, a connection post could be provided on the balloon or liner to allow attaching the stent to the balloon or liner. For example, a balloon inserted in aneurysm 302 could have a flanged lower post (similar to some helium balloons) that connector coil 314 could wrap around. In this case, if, for example, connector coil 314 was made out of SMAs, thermal activation could cause coil 314 to tighten around the post attached to the balloon and contract. The contraction would be resisted by the flange on the post tending to pull base 310 in towards aneurysm 302 to assist in seating base 310 about aneurysm 302. Alternatively to a post, the stent could have prongs that extend along the inside walls of the aneurysm such that the expanded balloon or liner would press the prongs against the wall of the aneurysm and seat the stent. Referring to FIG. 8, base 310 could be designed with a clamp 802 around an edge 804 of base 310. As shown, clamp 802 could have opposed surfaces 806 such that when deployed, surfaces 806 move together and grip vessel 302 at neck 306. A ridge 808 could be provided to assist in the grip. Clamp 802 would be particularly useful if aneurysm 304 was not packed with anything. Referring to FIGS. 9A and 9B, another stent 900 consistent with the present invention is shown. Stent 900 includes a base 910 and a connector 920. Un deployed, connector 920 is a tightly wrapped coil of material. On deployment, connector 920 unwinds into a bulbous or volumous area sufficiently to anchor the stent 900. Generally, connector 920 would expand to completely fill aneurysm space, but at a minimum the expansion should be sufficient to prevent connector 920 from pulling out of the aneurysm. As can be appreciated, stent 900 could be used to treat the aneurysm without packing material. But if packing material were used to treat the aneurysm, connector 920 would not need to expand as much.

FIGS. 10A and 10B show another stent 1000 consistent with the present invention. FIG. 10A shows a front plan view of a stent 1000 that includes a base 1010 and expanded connectors 1020 and 1030. While stent 1000 is shown with two orthogonal rings as connectors 1020 and 1030, more rings could be used. Further the rings could be cross-linked or individual rings. FIG. 10B shows a side plan view of stent 1000 also with expanded connectors 1020 and 1030. As can be seen, connectors 1020 and 1030, which are shown in the deployed state, expand to form rings that act similar to the corkscrew anchor above. Also, while shown as rings any shape is possible, such as diamond, circular, square, triangular, elliptical, helical, or the like. While the invention has been particularly shown and described with reference to a preferred embodiment thereof, it will be understood by those skilled in the art that various other changes in the form and details may be made without departing from the spirit and scope of the invention.

Claims

We claim:

1. An apparatus to inhibit flow to an aneurysm, comprising:

a base having a vessel facing side and an aneurysm facing side; the base comprising a shape sufficient to cover an aneurysm; a connector; and the connector coupled to the aneurysm facing side, wherein the connector is adapted to anchor the base about the aneurysm to inhibit flow into the aneurysm.

2. The apparatus according to claim 1, wherein the connector is a coil adapted to pack in the aneurysm.

3. The apparatus according to claim 2, wherein the connector is adapted to couple to at least one of the group consisting of: GDCs, balloons, liners, polymers, and clotting agents.

4. The apparatus according to claim 1, wherein: the base comprises an edge; and the connector has at least a first prong, such that the edge and at least the first prong form a clamp that grips the vessel wall to seat the base about the aneurysm.

5. The apparatus according to claim 1, wherein: the base comprises graft material.

6. The apparatus according to claim 1, wherein: the base comprises self-expanding material such that the base can be delivered in a small package and expands on deployment to cover the aneurysm.

7. The apparatus according to claim 6, wherein the base also comprises graft material.

8. The apparatus according to claim 1, wherein the connector comprises at least one coil adapted to engage GDCs packed in the aneurysm.

9. The apparatus according to claim 8, wherein the at least one coil is made of at least a first shaped memory alloy.

10. The apparatus according to claim 9, wherein the at least one coil is deformed such that on thermal treatment the at least one coil engages GDCs and provides a force tending to seat the base about the aneurysm.

11. The apparatus according to claim 1, wherein the base is at least one of a triangular shape, a circular shape, a conical shape, a spherical shape, an elliptical shape, a rectangμlar shape, and an irregular shape.

12. The apparatus according to claim 1, wherein the base resides completely in the vessel.

13. The apparatus according to claim 1, wherein the aneurysm facing side is coated with an adhesive.

14. The apparatus according to claim 1, wherein the connector comprises a post to be anchored in an occlusion in the aneurysm.

15. The apparatus according to claim 1, wherein the connector comprises at least one prong extending along an interior wall of the aneurysm, the at least one prong adapted to be held in place by at least one of a balloon or liner inserted in the aneurysm.

16. The apparatus according to claim 1, wherein the base comprises at least one base coil arranged to expand on deployment.

17. The apparatus according to claim 16, wherein the at least one base coil expands on activation.

18. The apparatus according to claim 16, wherein the at least one base coil is arranged in the shape of a spiral.

19. The apparatus according to claim 16, wherein the at least one base coil comprises a shaped memory alloy that is activated on thermal manipulation.

20. The apparatus according to claim 1, wherein the vessel facing side is coated with a material to stimulate cell growth and encourage formation of a pseudointima.

21. The apparatus according to claim 1, wherein the connector is a tightly wound coil of material that expands to a corkscrew shape to anchor the stent.

22. The apparatus according to claim 1, wherein the connector is a plurality of rings that expand to anchor the stent.

23. The apparatus according to claim 22, wherein the plurality of cross- linked rings are orthogonal.

24. An aneurysm stent, comprising: a base; at least one connector coupled to the base; the at least one connector adapted to be inserted into an aneurysm packed with GDCs and, upon insertion, to curl and pack into the aneurysm.

25. The aneurysm stent according to claim 24, wherein: the at least one connector is coupled to a geometric center of the base.

26. The aneurysm stent according to claim 24, wherein: the at least one connector is at least two connectors, each connector extending in the aneurysm.

27. The aneurysm stent according to claim 26, wherein: the at least two connectors are coupled to the base in a symmetrical manner.

28. The aneurysm stent according to claim 24, wherein the at least one connector is made of a first shaped memory alloy.

29. The aneurysm stent according to claim 28, wherein the base is made of a second shaped memory alloy.

30. The aneurysm stent according to claim 29, wherein the first shaped memory alloy and the second shaped memory alloy are the same.

3 1. The aneurysm stent according to claim 30, wherein the first shaped memory alloy and the second shaped memory alloy are nitinol.

32. The aneurysm stent according to claim 24, wherein the base has a vessel side and an aneurysm side, the vessel side comprises a layer of biocompatible material that promotes permanent fixation of the stent

33. The aneurysm stent according to claim 32, wherein the biocompatible material is a graft coated with a material to stimulate cell growth and encourage formation of a pseudointima.

34. The aneurysm stent according to claim 32, wherein the aneurysm side has a layer of adhesive.

35. An apparatus to inhibit flow to an aneurysm, comprising:

a base having a vessel facing side and an aneurysm facing side; the base comprising a shape sufficient to cover an aneurysm; and means for anchoring the base about the aneurysm to inhibit flow into the aneurysm.

36. The apparatus according to claim 35, wherein the means for anchoring comprises: at least one of a coil, a post, a prong, and a clamp.

37. A method for obstructing the flow of blood through the neck of an aneurysm, the method comprising the steps of: passing a catheter to the site of an aneurysm; inserting an anchor into the aneurysm; deploying an aneurysm base to block the neck of the aneurysm; and anchoring the aneurysm base about the neck of the aneurysm using the anchor to inhibit the flow of blood in the aneurysm.

38. The method according to claim 37, further comprising the step of: packing material in the aneurysm to form an occlusion.

39. The method according to claim 38, wherein the anchoring step includes engaging the anchor with the packed material.

40. The method according to claim 38, wherein the anchoring step further includes the step of: providing a seating force to assist in seating the aneurysm base about the neck of the aneurysm. '

41. The method according to claim 37, further comprising the steps of: providing an adhesive coating on the aneurysm base; and adhering the aneurysm base to the vessel during deployment.

42. An aneurysm stent, comprising: a base; at least one connector coupled to the base; the at least one connector adapted to be inserted into an aneurysm and, upon insertion, to anchor the base about a neck of the aneurysm.

43. The aneurysm stent according to claim 42, wherein the at least one connector comprises: at least one tightly wound coil that extends from the base into the aneurysm; the at least one tightly wound coil expands after insertion to pack the aneurysm and anchor the stent.

44. The aneurysm stent according to claim 43, wherein the at least one tightly wound coil expands into a corkscrew shape.

45. The aneurysm stent according to claim 42, wherein the at least one connector comprises at least one of a plurality of coils, a plurality of prongs, and a plurality of posts.

46. The aneurysm stent according to claim 45, wherein the plurality of cross-linked coils are orthogonal.