Endovascular device

• US 8,262,692 B2
• Filed: 09/05/2008
• Issued: 09/11/2012
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: Merlin MD Pte. Ltd.
• Original Assignee: Merlin MD Pte. Ltd.
• Inventors: Rudakov, Leon
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US12/205,827
• Publication Number:
  US 20100063582A1
• Time in Patent Office: 1,467 Days
• Field of Search: 606/153, 606/191, 606/200, 606/213, 623/1.1, 623/1.13, 623/1.36, 623/1.49
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

Embodiments of an endovascular device and of methods for treating an aneurysm therewith are described. In certain embodiments, an endovascular device includes a distal assembly coupled to a flow reducing member. In some embodiments, the distal assembly is composed of multiple engagement members that, when deployed within an aneurysm, engage an inner surface of the aneurysm. In certain embodiments, the engagements members are substantially parallel to a central axis of the distal assembly in a first position and shift away from the central axis to a second position, and the distal ends of some engagement members are substantially curled when in the second position. In certain embodiments, the flow-reducing member reduces blood flow from a blood vessel into the aneurysm. In certain embodiments the flow reducing member includes a membrane, which can include a porous section.

Claims

1. An endovascular device, for treating an aneurysm of a body vessel, comprising:

a distal assembly, movable from a first position to a second position when the distal assembly is at least partially in an aneurysm; and

a first flow-reducing member, coupled to the distal assembly, that reduces blood flow from the body vessel into the aneurysm when the distal assembly is in the second position;

wherein the distal assembly comprises a plurality of engagement members, each of which extends, from a proximal portion to a distal portion, away from the flow-reducing member;

wherein, when the distal assembly is in the first position, each of the plurality of engagement members is substantially parallel to a central axis of the distal assembly;

wherein, when the distal assembly changes from the first to the second position, the distal portion of each of the plurality of engagement members moves away from the central axis, such that the distal portions of each of the plurality of engagement members;

substantially curl;

move closer to the first flow-reducing member; and

engage an inner surface of the aneurysm;

the device further comprising a second flow-reducing member, coupled to the first flow-reducing member or to the distal assembly, that reduces blood flow from the body vessel into the aneurysm when the distal assembly is in the second position;

the device further comprising a linking member that couples the second flow-reducing member to the first flow-reducing member or to the distal assembly;

wherein the second flow-reducing member comprises a plug, and wherein, when the distal assembly is in the second position, the plug is configured to reside substantially within a neck of the aneurysm and substantially inhibits blood flow through the neck of the aneurysm.

2. The endovascular device of claim 1, wherein at least one of the plurality of engagement members comprises a polymer selected from the group consisting of ePTFE, polyurethane, polyethylene terephthalate, polyvinylchloride, nylon, polyimide, polyurethane ether, polyurethane ester, polyurethaneurea, polylactide, polyglycolide, poly-orthoester, polyphosphazene, polyanhydride, and polyphosphoester.

3. The endovascular device of claim 1, wherein at least one of the plurality of engagement members comprises a metal selected from the group consisting of NiTi, tungsten, stainless steel, iridium, and platinum.

4. The endovascular device of claim 1, wherein a distal end of at least one of the plurality of engagement members is blunt.

5. The endovascular device of claim 1, wherein, when the distal assembly is in the second position, a distal end of each of the plurality of engagement members engages the inner surface of the aneurysm.

6. The endovascular device of claim 1, wherein, when the distal assembly is in the second position, the first flow-reducing member is configured to reside in the body vessel.

7. The endovascular device of claim 1, wherein, when the distal assembly is in the second position, the first flow-reducing member is configured to reside in the aneurysm.

8. The endovascular device of claim 1, wherein, when the distal assembly is in the second position, the first flow-reducing member is configured to reside in the body vessel and the second flow-reducing member is configured to reside in the aneurysm.

9. The endovascular device of claim 1, wherein at least one of the linking member, the distal assembly, the first flow-reducing member, and the second flow- reducing member comprises at least one metal selected from the group consisting of NiTi, tungsten, stainless steel, iridium, and platinum.

10. The endovascular device of claim 1, wherein the linking member comprises a wire.

11. The endovascular device of claim 1, wherein each of the linking member, the first flow-reducing member, the second flow-reducing member, and the distal assembly comprises a metal, and wherein a weld couples the linking member to at least one of the distal assembly, the first flow-reducing member, and the second flow-reducing member.

12. The endovascular device of claim 1, wherein the first flow-reducing member comprises a membrane.

13. The endovascular device of claim 12, wherein the membrane comprises at least one polymer selected from the group consisting of ePTFE, polyurethane, polyethylene terephthalate, polyvinylchloride, nylon, polyimide, silicone, polyurethane ether, polyurethane ester, polyurethaneura, polylactide, polyglycolide, poly-orthoester, polyphosphazene, polyanhydride, and polyphosphoester.

14. The endovascular device of claim 12, wherein the first flow-reducing member is coupled to the distal assembly by suture or interweaving.

15. The endovascular device of claim 12, wherein at least a portion of the membrane is non-porous.

16. The endovascular device of claim 12, wherein the membrane comprises a porous section having a porosity over a length extending from a proximal end of the porous section to a distal end of the porous section;

wherein a pore spacing and a pore size of the porous section determine the porosity of the porous section;

wherein, when the distal assembly is in the second position, the membrane is effective to reduce blood flow into the aneurysm and to promote thrombosis at or in the aneurysm.

17. The endovascular device of claim 16, wherein the porosity is selected such that, when the distal assembly is in the second position, the porous section of the membrane is effective to enhance endothelial cell migration and tissue growth onto the membrane and to substantially inhibit blood flow from the body vessel into the aneurysm.

18. The endovascular device of claim 16, wherein a material ratio of the porous section of the membrane comprises a ratio of a total area of an outer surface of the porous section of the membrane that comprises material to a total area of an outer surface of the porous section that comprises pores.

19. The endovascular device of claim 12, further comprising at least one agent, permanently attached to the membrane, that, when the distal assembly is in the second position, promotes healing of the aneurysm.

20. The endovascular device of claim 19, wherein the at least one agent comprises at least one of a peptide, a protein, an enzyme regulator, an antibody, a naturally occurring molecule, a synthetic molecule, a nucleic acid, a polynucleotide, L-PDMP, and D-PDMP.

21. A method of treating an aneurysm of a body vessel comprising:

providing an endovascular device comprising;

a distal assembly, movable from a first position to a second position when the distal assembly is at least partially within an aneurysm, the distal assembly comprising a plurality of engagement members, each of which extends, from a proximal portion to a distal portion, away from the flow-reducing member and each of which, when the distal assembly is in the first position, is substantially parallel to a central axis of the distal assembly; and

a first flow-reducing member, coupled to the distal assembly, that reduces blood flow from the body vessel into the aneurysm when the distal assembly is in the second position;

positioning the distal assembly at least partially within the aneurysm; and

changing the distal assembly from the first position to the second position such that the distal portion of each of the plurality of engagement members moves away from the central axis, whereby the distal portions of each of the plurality of engagement members;

substantially curl;

move closer to the first flow-reducing member; and

engage an inner surface of the aneurysm;

wherein the endovascular device further comprises a second flow-reducing member, coupled to the first flow-reducing member or to the distal assembly, that reduces blood flow from the body vessel into the aneurysm when the distal assembly is in the second position; and

further comprising;

positioning the second flow-reducing member at least partially in the aneurysm;

wherein the endovascular device further comprises a linking member that couples the second flow-reducing member to the first flow-reducing member or to the distal assembly;

wherein the second flow-reducing member comprises a plug, and wherein, when the distal assembly is in the second position, the plug is configured to reside substantially within a neck of the aneurysm and substantially inhibits blood flow through the neck of the aneurysm.

22. The method of claim 21, wherein at least one of the plurality of engagement members comprises a polymer selected from the group consisting of ePTFE polyurethane, polyethylene terephthalate, polyvinylchloride, nylon, polyimide, polyurethane ether, polyurethane ester, polyurethaneurea, polylactide, polyglycolide, poly-orthoester, polyphosphazene, polyanhydride, and polyphosphoester.

23. The method of claim 21, wherein at least one of the plurality of engagement members comprises at least one metal selected from the group consisting of NiTi, tungsten, stainless steel, iridium, and platinum.

24. The method of claim 21, wherein a distal end of at least one of the plurality of engagement members is blunt.

25. The method of claim 21, wherein, when the distal assembly is in the second position, a distal end of each of the plurality engagement members engages the inner surface of the aneurysm.

26. The method of claim 21, wherein, when the distal assembly is in the second position, the first flow-reducing member is configured to reside in the body vessel.

27. The method of claim 21, wherein, when the distal assembly is in the second position, the first flow-reducing member is configured to reside in the aneurysm.

28. The method of claim 21, wherein, when the distal assembl, is in the second position, the first flow-reducing member is configured to reside in the body vessel and the second flow-reducing member is configured to reside in the aneurysm.

29. The method of claim 21, wherein the first flow-reducing member comprises a membrane.

30. An endovascular device, for treating an aneurysm of a body vessel, comprising:

a distal assembly, movable from a first position to a second position when the distal assembly is at least partially in an aneurysm; and

a first flow-reducing member, coupled to the distal assembly, that reduces blood flow from the body vessel into the aneurysm when the distal assembly is in the second position;

wherein the distal assembly comprises a plurality of engagement members, each of which extends, from a proximal portion to a distal portion, away from the flow-reducing member;

wherein, when the distal assembly is in the first position, each of the plurality of engagement members is substantially parallel to a central axis of the distal assembly;

wherein, when the distal assembly changes from the first to the second position, the distal portion of each of the plurality of engagement members moves away from the central axis, such that the distal portions of each of the plurality of engagement members;

substantially curl;

move closer to the first flow-reducing member; and

engage an inner surface of the aneurysm;

the device further comprising a second flow-reducing member, coupled to the first flow-reducing member or to the distal assembly, that reduces blood flow from the body vessel into the aneurysm when the distal assembly is in the second position;

the device further comprising a linking member that couples the second flow-reducing member to the first flow-reducing member or to the distal assembly;

wherein the second flow-reducing member comprises a plug, and wherein, when the distal assembly is in the second position, the plug is configured to reside substantially within a neck of the aneurysm and substantially inhibits blood flow through the neck of the aneurysm;

wherein the plug comprises a balloon.

31. The endovascular device of claim 30, wherein at least one of the plurality of engagement members comprises a polymer selected from the group consisting of ePTFE, polyurethane, polyethylene terephthalate, polyvinylchloride, nylon, polyimide, polyurethane ether, polyurethane ester, polyurethaneurea, polylactide, polyglycolide, poly-orthoester, polyphosphazene, polyanhydride, and polyphosphoester.

32. The endovascular device of claim 30, wherein at least one of the plurality of engagement members comprises a metal selected from the group consisting of NiTi, tungsten, stainless steel, iridium, and platinum.

33. The endovascular device of claim 30, wherein a distal end of at least one of the plurality of engagement members is blunt.

34. The endovascular device of claim 30, wherein, when the distal assembly is in the second position, a distal end of each of the plurality of engagement members engages the inner surface of the aneurysm.

35. The endovascular device of claim 30, wherein, when the distal assembly is in the second position, the first flow-reducing member is configured to reside in the body vessel.

36. The endovascular device of claim 30, wherein, when the distal assembly is in the second position, the first flow-reducing member is configured to reside in the aneurysm.

37. The endovascular device of claim 30, wherein, when the distal assembly is in the second position, the first flow-reducing member is configured to reside in the body vessel and the second flow-reducing member is configured to reside in the aneurysm.

38. The endovascular device of claim 30, wherein at least one of the linking member, the distal assembly, the first flow-reducing member, and the second flow-reducing member comprises at least one metal selected from the group consisting of NiTi, tungsten, stainless steel, iridium, and platinum.

39. The endovascular device of claim 30, wherein the linking member comprises a wire.

40. The endovascular device of claim 30, wherein each of the linking member, the first flow-reducing member, the second flow-reducing member, and the distal assembly comprises a metal, and wherein a weld couples the linking member to at least one of the distal assembly, the first flow-reducing member, and the second flow-reducing member.

41. The endovascular device of claim 30, wherein the first flow-reducing member comprises a membrane.

42. The endovascular device of claim 41, wherein the membrane comprises at least one polymer selected from the group consisting of ePTFE, polyurethane, polyethylene terephthalate, polyvinylchloride, nylon, polyimide, silicone, polyurethane ether, polyurethane ester, polyurethaneura, polylactide, polyglycolide, poly-orthoester, polyphosphazene, polyanhydride, and polyphosphoester.

43. The endovascular device of claim 41, wherein the first flow-reducing member is coupled to the distal assembly by suture or interweaving.

44. The endovascular device of claim 41, wherein at least a portion of the membrane is non-porous.

45. The endovascular device of claim 41, wherein the membrane comprises a porous section having a porosity over a length extending from a proximal end of the porous section to a distal end of the porous section;

wherein a pore spacing and a pore size of the porous section determine the porosity of the porous section;

wherein, when the distal assembly is in the second position, the membrane is effective to reduce blood flow into the aneurysm and to promote thrombosis at or in the aneurysm.

46. The endovascular device of claim 45, wherein the porosity is selected such that, when the distal assembly is in the second position, the porous section of the membrane is effective to enhance endothelial cell migration and tissue growth onto the membrane and to substantially inhibit blood flow from the body vessel into the aneurysm.

47. The endovascular device of claim 46, wherein a material ratio of the porous section of the membrane comprises a ratio of a total area of an outer surface of the porous section of the membrane that comprises material to a total area of an outer surface of the porous section that comprises pores.

48. The endovascular device of claim 41, further comprising at least one agent, permanently attached to the membrane, that, when the distal assembly is in the second position, promotes healing of the aneurysm.

49. The endovascular device of claim 48, wherein the at least one agent comprises at least one of a peptide, a protein, an enzyme regulator, an antibody, a naturally occurring molecule, a synthetic molecule, a nucleic acid, a polynucleotide, L-PDMP, and D-PDMP.