Aneurysm treatment devices and methods

• US 8,771,294 B2
• Filed: 04/21/2005
• Issued: 07/08/2014
• Est. Priority Date: 11/26/2004
• Status: Expired due to Fees

• Current Assignee: Biomerix Corp., Biometrix, Ltd. (Q Holding Company)
• Original Assignee: Biomerix Corp.
• Inventors: Sepetka, Ivan, Aboytes, Maria, Jordan, Maybelle, Friedman, Craig, Datta, Arindam
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US11/111,487
• Publication Number:
  US 20060116712A1
• Time in Patent Office: 3,365 Days
• Field of Search: 606/144, 424/426, 424/144
• US Class Current: 606/144
• 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 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

An aneurysm treatment device for in situ treatment of aneurysms comprises a collapsible member having a first shape wherein the first shape is an expanded geometric configuration, and a second shape, wherein the second shape is a collapsed configuration that is loadable into a catheter. The aneurysm treatment device is capable or returning to the first shape in the sac of an aneurysm upon deployment, where it occludes the aneurysm. In another embodiment an occlusion device comprises a flexible, longitudinally extending elastomeric matrix member that assumes a non-linear shape to conformally fill a targeted vascular site.

Claims

1. An occlusion device for occluding a cerebral aneurysm comprising

a member comprising a porous, explosively reticulated, elastomeric matrix, wherein the porous, explosively reticulated elastomeric matrix has at least partially removed cell walls between adjoining pores of the porous, explosively reticulated elastomeric matrix, and

at least one longitudinally extending reinforcing filament,

wherein the porous, explosively reticulated elastomeric matrix comprises a cross-linked, biodurable, reticulated, resilient elastomeric matrix comprising interconnected and intercommunicating networks of pores, channels, and voids, configured to permit ingrowth of tissue into the interconnected and intercommunicating networks of pores, channels, and voids,

wherein the elastomeric matrix comprises polycarbonate polyurethane-urea, polycarbonate polyurea-urethane, polycarbonate polyurethane, polycarbonate polysiloxane polyurethane, or polysiloxane polyurethane, or a copolymers thereof, or any mixture thereof,

wherein the elastomeric matrix is at least partially hydrophobic,

wherein the device is configured to assume a non-linear shape that conformally fills a targeted vascular site, and

wherein the device is configured to prevent recanalization and migration after tissue ingrowth has taken place in the reticulated matrix.

2. The device of claim 1, wherein there are two longitudinally extending reinforcing filaments.

3. The device of claim 2, wherein the reinforcing filaments are knotted or looped together at various points to secure the elastomeric matrix.

4. The device of claim 3, where the reinforcing filaments are knotted together by radiopaque bands.

5. The device of claim 2, wherein one longitudinally extending reinforcing filament comprises shape memory material and the other longitudinally extending reinforcing filament comprises radiopaque material.

6. The device of claim 5, wherein one longitudinally extending reinforcing filament comprises nitinol and the other longitudinally extending reinforcing filament comprises platinum.

7. The device of claim 6, wherein one longitudinally extending reinforcing filament is a nitinol wire and the other longitudinally extending reinforcing filament is a platinum coil.

8. The device of claim 1, wherein at least one reinforcing filament is radiopaque.

9. The device of claim 1, wherein the elastomeric matrix is formed from an isocyanate component comprising diphenylmethane diisocyanate, wherein the diphenylmethane diisocyanate is a mixture of 2,4′

-diphenylmethane diisocyanate, 4,4′

-diphenylmethane diisocyanate, polymeric MDI, and mixtures thereof.

10. The device of claim 1 which prevents recanalization and migration after tissue ingrowth has taken place in the reticulated structure.

11. The vascular occlusion device of claim 1,

wherein the longitudinally extending component is configured to be engaged with the member to secure the member and assist the device in conformally filling a cerebral aneurysm.

12. The vascular occlusion device of claim 11, wherein the member comprises resiliently compressible material.

13. The vascular occlusion device of claim 11, wherein each longitudinally extending component is selected from the group consisting of platinum wire, polymeric fiber or filament, a braid of platinum wire and polymeric fiber or filament, and a braid of two or more platinum wires.

14. The vascular occlusion device of claim 11, wherein there are two longitudinally extending components.

15. The vascular occlusion device of claim 14, wherein one longitudinally extending component comprises shape memory material and the other longitudinally extending component comprises radiopaque material.

16. The vascular occlusion device of claim 15, wherein one longitudinally extending component comprises nitinol and the other longitudinally extending component comprises platinum.

17. The vascular occlusion device of claim 16, wherein one longitudinally extending component is a nitinol wire and the other longitudinally extending component is a platinum coil.

18. The vascular occlusion device of claim 11 which prevents recanalization and migration after tissue ingrowth has taken place in the reticulated structure.

19. The occlusion device of claim 11, wherein the elastomeric matrix comprises polycarbonate polyurethane-urea, polycarbonate polyurea-urethane, polycarbonate polyurethane, or any mixture thereof.

20. The occlusion device of claim 1, wherein the elastomeric matrix comprises polycarbonate polyurethane-urea, polycarbonate polyurea-urethane, polycarbonate polyurethane, or any mixture thereof.

21. The occlusion device of claim 1, wherein the member comprises resiliently compressible material.

22. The occlusion device of claim 1, wherein the elastomeric matrix is free from a hydrogel.

23. The occlusion device of claim 1, wherein the elastomeric matrix is formed from a polyol component wherein the polyol component comprises polycarbonate polyol, polysiloxane polyol, poly(carbonate-co-siloxane) polyol, and mixtures thereof.

24. A packaging or introducer system comprising:

an occlusion device of claim 1.

25. The system of claim 24, further comprising an introducer sheath having a longitudinally extending lumen and proximal and distal ends;

a side arm attached to the proximal end of the introducer sheath and having a hemostasis valve and a flusher port; and

a pusher member extending through the hemostasis valve into the introducer sheath and having a distal end removably engaged to the proximal end of the occlusion device;

wherein the occlusion device is positioned within said lumen, said occlusion device having a proximal end; and

wherein an interlocking wire having a distal end extends longitudinally into the pusher member, the occlusion device has a loop at its proximal end, the distal end of the pusher member has an opening through which said loop extends, the distal end of the interlocking wire is releasably held within the distal end of the pusher member, and the distal end of the interlocking wire releasably engages said loop so that the distal end of the pusher member releasably engages the proximal end of the occlusion device.

26. The system of claim 25, wherein the distal end of the interlocking wire and the distal end of the pusher member are both radiopaque.

27. A method for occluding a cerebral aneurysm comprising:

introducing an introducer system of claim 24 into a delivery catheter having a longitudinally extending lumen and proximal and distal ends;

withdrawing the introducer sheath and side arm, leaving the occlusion device positioned within the lumen of the delivery catheter;

advancing the occlusion device using the pusher member to position the occlusion device within a targeted vascular site;

disengaging the pusher member from the occlusion device; and

withdrawing pusher member.

28. An occlusion device comprising

a member comprising a porous, explosively reticulated elastomeric matrix, wherein the porous, explosively reticulated elastomeric matrix by explosion has at least partially removed cell walls between adjoining pores of the porous, explosively reticulated elastomeric matrix such that the explosively reticulated elastomeric matrix comprises interconnected and intercommunicating networks of pores, channels, and voids, and

at least one longitudinally extending component,

wherein the interconnected and intercommunicating networks of pores, channels, and voids are configured to permit ingrowth of tissue into the interconnected and intercommunicating networks of pores, channels, and voids,

wherein the device is configured to assume a non-linear shape that conformally fills a targeted vascular site.

29. An occlusion device comprising

a member comprising a porous, explosively reticulated elastomeric matrix, wherein the porous, explosively reticulated elastomeric matrix by explosion has at least partially removed cell walls between adjoining pores of the porous, explosively reticulated elastomeric matrix such that the explosively reticulated elastomeric matrix comprises interconnected and intercommunicating networks of pores, channels, and voids, and

at least one longitudinally extending component,

wherein the interconnected and intercommunicating networks of pores, channels, and voids is configured to permit ingrowth of tissue into the interconnected and intercommunicating networks of pores, channels, and voids,

wherein the device is configured to be in a collapsed form and assume a non-linear shape in-situ within the aneurysm to conformally fill the aneurysm.

30. The occlusion device of claim 29, wherein the elastomeric matrix provides support and resilient compressibility enabling the device to be in the collapsed form for delivery to the aneurysm.

31. The occlusion device of claim 30, wherein the reinforcing filaments are knotted or looped together at various points to secure the elastomeric matrix, and wherein one longitudinally extending reinforcing filament comprises shape memory material and the other longitudinally extending reinforcing filament comprises radiopaque material.

32. The occlusion device of claim 29, wherein the elastomeric matrix comprises polycarbonate polyurethane-urea, polycarbonate polyurea-urethane, polycarbonate polyurethane, or any mixture thereof.