Aneurysm occlusion system and method

• US 20070239261A1
• Filed: 04/06/2007
• Published: 10/11/2007
• Est. Priority Date: 04/07/2006
• Status: Abandoned Application

• Current Assignee: Penumbra, Inc.
• Original Assignee: Penumbra, Inc.
• Inventors: Gupta, Vikas, Barry, David, Hui, Delilah, Bose, Arani, Leynov, Aleksandr
• Application Number:
  US11/784,236
• Publication Number:
  US 20070239261A1
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0095 : Saddle-shaped
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

An aneurysm occlusion device is positionable within a cerebral blood vessel covering a neck of an aneurysm on the blood vessel. The device includes a tubular element having a lumen surrounded by an occlusive sidewall including a plurality of gaps. The gaps are sufficiently small to cause at least partial occlusion against flow of blood from the blood vessel through the side wall into the aneurysm, but are expandable in response to a fluid pressure differential between a first area inside the lumen and a second area outside the lumen to allow flow of fluid through the side wall between the blood vessel and a side branch vessel.

Claims

1. An aneurysm occlusion device positionable within a cerebral blood vessel covering a neck of an aneurysm on the blood vessel, the device comprising:

a tubular element having a lumen, the tubular element including an occlusive sidewall including a plurality of gaps, the gaps of a size sufficiently small to cause at least partial occlusion against flow of blood from the blood vessel through the side wall into the aneurysm, wherein the gaps are proportioned to allow flow of fluid through the side wall between the blood vessel and a side branch vessel in response to a fluid pressure differential between a first area inside the lumen and a second area outside the lumen.

2. The occlusion device of claim 1, wherein the gaps are expandable in response to the fluid pressure differential to allow flow of fluid through the side wall.

3. The occlusion device of claim 1, wherein the tubular element includes a plurality of bands having the gaps between them, and at least two elongate members extending from a proximal portion of the sidewall to a distal portion of the sidewall, each band including at least one end connected to one of the elongate members.

4. The occlusion device of claim 1, wherein each band includes a first end connected to a first one of the elongate members and a second end connected to a second one of the elongate members.

5. The occlusion device of claim 2, wherein the bands are deflectable in response to the fluid pressure differential to expand the gaps.

6. The occlusion device of claim 1, wherein the bands are parallel to one another.

7. The occlusion device of claim 1, wherein the elongate members extend longitudinally from a proximal portion of the sidewall to a distal portion of the sidewall.

8. The occlusion device of claim 1, wherein the elongate members include flexures.

9. The occlusion device of claim 1, wherein the tubular element includes between 2-8 elongate members.

10. The occlusion device of claim 1, wherein the elongate members extend helically from the proximal portion to the distal portion.

11. The occlusion device of claim 1, wherein the bands include a first portion having a first width, and second portion having a second width, wherein the first width is greater than the second width.

12. The occlusion device of claim 1, wherein the bands are v-shaped bands having an apex, the apex extending in a longitudinal direction.

13. The occlusion device of claim 11, wherein the bands have a first leg and a second joined at the apex, and wherein the first leg is wider than the second leg.

14. The occlusion device of claim 1, wherein the tubular element is an outer tubular element and wherein the device further includes an inner tubular element having a second occlusive sidewall, the inner tubular element positionable within the lumen of the outer tubular element with the second occlusive sidewall overlapping the sidewall of the outer tubular element.

15. The occlusion device of claim 14, wherein the second occlusive sidewall includes a plurality of second bands and at least two second elongate members extending from a proximal portion of the second sidewall to a distal portion of the second sidewall, each second band including at least one end connected to one of the second elongate members.

16. The occlusion device of claim 15, wherein the elongate members of the outer tubular element extend helically in a first direction, and wherein the second elongate members of the inner tubular element extending helically in a second direction opposite from the first direction.

17. The occlusive device of claim 16, wherein the first direction is clockwise and the second direction is counterclockwise.

18. The occlusive device of claim 16, wherein the first direction is counterclockwise and the first direction is clockwise.

19. The occlusive device of claim 1, wherein the occlusive device is functionally uniform around the circumference of the occlusive sidewall.

20. The occlusion device of claim 1, wherein the tubular member is radially expandable from a compressed position within a sheath to an expanded position within a blood vessel, and wherein the tubular member has a length in the compressed position that is longer than the length in the expanded position by an amount less than or equal to 15%.

21. The occlusive device of claim 1, wherein the tubular member is proportioned to be compressible to a diameter suitable for insertion into a microcatheter having an inner diameter of 2 mm or less.

22. The occlusion device of claim 1, wherein the tubular element includes a proximal section positioned proximally of the occlusive sidewall portion, and a distal section position distally of the occlusive sidewall portion, the proximal and distal sections including sidewalls that are less occlusive to blood flow than the occlusive sidewall portion.

23. The occlusion device of claim 1, wherein the sidewalls are non-braided and non-woven.

24. The occlusive device of claim 14, wherein the bands and the elongate elements are cut from a length of tubing.

25. The occlusive device of claim 1, wherein the tubular member includes a first end positionable in a first blood vessel and a bifurcated second end having bifurcated sections positionable in second and third vessels.

28. The method of claim 27, wherein occlusion device of claim 1 wherein the tubular element includes a plurality of bands having the gaps between them, and wherein the bands deflect in response to the fluid differential to expand the gaps.

26. A method of treating an aneurysm in a blood vessel, comprising the steps of:

introducing into the blood vessel a tubular element having an occlusive sidewall, the sidewall defining a lumen and including a plurality of gaps,

covering a neck of the aneurysm with the occlusive sidewall, wherein the tubular element substantially occludes flow of blood through the sidewall into the aneurysm, and wherein the gaps, in response to a fluid pressure differential between a first area inside the lumen and a second area outside the lumen, allow flow of fluid through the side wall between the blood vessel and a side branch vessel.

27. The method according to claim 26, wherein the gaps expand in response to a fluid pressure differential between the first area and the second area.

29. The method of claim 26, wherein the tubular element is an outer tubular element and wherein the method further includes positioning an inner tubular element having a second occlusive sidewall within the lumen of the outer tubular element.

30. The method of claim 29, wherein the inner tubular element is introduced into the lumen after the outer tubular element is introduced into the blood vessel.

31. The method of claim 29, wherein the inner tubular element includes first radiopaque markers, wherein the second tubular element includes second radiopaque markers, and wherein the method includes aligning the first and second markers under fluoroscopic visualization.

32. The method of claim 26, wherein the tubular element includes a first end and a bifurcated end having first and second bifurcations, and wherein the method includes positioning the first end in a first blood vessel, positioning the first bifurcation in a second blood vessel, and positioning the second bifurcation in a third blood vessel.

33. The method of claim 26, wherein the method includes radially compressing the tubular element, inserting the tubular element into a sheath, passing the sheath into the cerebral blood vessel, and releasing the tubular element from the sheath to cover the neck.

34. The method of claim 33, wherein the method includes fluroscopically observing release of the tubular element from the sheath.

35. The method of claim 34, wherein the method includes, during the releasing step, withdrawing the tubular element from the blood vessel into the sheath, repositioning the sheath, and releasing the tubular element from the sheath.

36. The method according to claim 33, wherein the method includes:

positioning a distal portion of the tubular element in the sheath, wherein the sheath is a distal sheath;

positioning the proximal portion of the tubular element in a second sheath;

passing the device with the sheaths thereon into the blood vessel;

removing the distal sheath to release the distal portion of the tubular element; and

removing the proximal sheath to release the proximal portion of the tubular element.

37. The method according to claim 36, wherein removing the distal sheath includes pushing the distal sheath in a distal direction, and wherein removing the proximal sheath includes withdrawing the proximal sheath in a proximal direction.

38. The method according to claim 36, wherein the step of removing the distal sheath is performed prior to the step of removing the proximal sheath.