Embolic filtering devices

• US 8,262,689 B2
• Filed: 09/28/2001
• Issued: 09/11/2012
• Est. Priority Date: 09/28/2001
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Schneiderman, Gary, Patel, Anuja H., Muller, Paul F., Boyle, William J., Hassing, Thomas A., Majcher, Thomas H.
• Primary Examiner(s): Severson, Ryan
• Application Number:
  US09/967,906
• Publication Number:
  US 20030065354A1
• Time in Patent Office: 4,001 Days
• Field of Search: 606/200, 606191-198, 606/108, 623/1.15, 623/1.11, 623/1.12
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A self-expanding basket for use in conjunction with an embolic filtering device has a proximal set of struts which are connected to a distal set of struts by a bending region which provides enhanced bending characteristics to the basket. The bending region can be formed by intermediate links which are extremely flexible and bendable to allow the basket to be delivered through tortuous anatomy. The intermediate links are extremely flexible and create a mechanical hinge-like connection between the proximal and distal strut assemblies. The basket thus is capable of substantial bending when being delivered through the patient'"'"'s vasculature and will bend and conform to the patient'"'"'s anatomy once positioned for filtering purposes. The intermediate links can also lengthen, when needed, when positioned in a curved vessel in the patient'"'"'s vasculature, when needed. As a result, the basket will easily conform to a curved body vessel to maintain proper wall apposition of the filtering element with the wall of the body vessel.

Claims

1. An embolic filtering device used to capture embolic debris in a body vessel, the device comprising:

a guide wire;

a proximal strut assembly including a plurality of struts adapted to move between an unexpanded position and an expanded position and a deployment ring attached to the struts;

a distal strut assembly including a deployment ring movable between an unexpanded position and an expanded position;

a bending region disposed between and connecting the proximal strut assembly and the distal strut assembly, wherein each of the proximal strut assembly, distal strut assembly and bending region has a particular bending stiffness, the bending region having the lowest bending stiffness and a nominal longitudinal length capable of expanding or contracting when the basket is in the expanded position and each of the deployment rings of the proximal strut assembly and distal strut assembly has an undulating pattern of peaks and valleys, the bending region including a plurality of interconnecting links attached to the peaks of the deployment rings to connect the proximal strut assembly with the distal strut assembly; and

a filtering element having a proximal end with a proximal edge forming a proximal inlet opening and a plurality of distal outlet openings, the outlet openings allowing the body fluid to flow through the filtering element but retaining embolic debris within the filtering element, the proximal inlet opening being larger than the outlet openings, the proximal edge of the filtering element being attached directly to the distal strut assembly.

2. The filtering device of claim 1, wherein the distal strut assembly further includes a plurality of struts attached to the deployment ring.

3. The filtering device of claim 1, wherein the proximal edge of the filtering element is attached to the deployment ring of the distal strut assembly.

4. The filtering device of claim 1, wherein the proximal edge of the filtering element has the same undulating pattern of the deployment ring of the distal strut assembly.

5. An embolic filtering device used to capture embolic debris in a body vessel, comprising:

a guide wire having a proximal end and a distal end; and

an expandable filter assembly including a self-expanding basket having a proximal strut assembly adapted to move between an unexpanded position and an expanded position, a distal strut assembly adapted to move between an unexpanded position and an expanded position and a bending region disposed between and connecting the proximal strut assembly and the distal strut assembly;

a filtering element having a proximal end with a proximal edge forming a proximal inlet opening and a plurality of distal outlet openings, the outlet openings allowing the body fluid to flow through the filtering element but retaining embolic debris within the filtering element, the inlet opening being larger than the outlet openings and the proximal edge of the filtering element being attached directly to the distal strut assembly; and

means for mounting the expandable filter assembly to the guide wire, wherein the bending region is made from a material having a different composition than the proximal strut assembly and distal strut assembly and has a longitudinal length capable of expanding or contracting when the basket is in the expanded position.

6. The filtering device of claim 5, wherein the bending region is made from a material which is more flexible than the material forming the proximal strut assembly and distal strut assembly.

7. An embolic filtering device used to capture embolic debris in a body vessel, the device comprising:

a guide wire;

a plurality of struts connected together to form a proximal strut assembly adapted to move between an unexpanded position and an expanded position;

a plurality of struts connected together to form a distal strut assembly movable between an unexpanded position and an expanded position;

a bending region disposed between and connecting the proximal strut assembly and the distal strut assembly, wherein the bending region includes a plurality of intermediate links connecting the proximal strut assembly and the distal strut assembly and at least one intermediate link has a nominal longitudinal length which is capable of expanding or contracting when the basket is in the expanded position and the intermediate links are subjected to a certain amount of force; and

a filtering element having a proximal end with a proximal edge forming a proximal inlet opening and a plurality of distal outlet openings, the outlet openings allowing the body fluid to flow through the filtering element but retaining embolic debris within the filtering element, the proximal inlet opening being larger than the outlet openings and the proximal edge of the filtering element being attached directly to the distal strut assembly.

8. The filtering device of claim 7, wherein each intermediate link has a nominal length which is capable of expanding or contracting when subjected to a certain amount of force.

9. The filtering device of claim 7, wherein the intermediate links are made from a different material than the proximal strut assembly and distal strut assembly.

10. The filtering device of claim 7, wherein each intermediate link is independently capable of expanding or contracting when subjected to a certain amount of force.

11. The filtering device of claim 7, wherein each intermediate link includes an S-shape portion.

12. The filtering device of claim 11, wherein the S-shape portion of the intermediate link is capable of expanding or contracting when subjected to a certain amount of force.

13. The filtering device of claim 7, wherein each intermediate link includes a Z-shape portion.

14. The filtering device of claim 13, wherein the Z-shape portion of the intermediate link is capable of expanding or contracting when subjected to a certain amount of force.

15. The filtering device of claim 7, wherein each intermediate link is made from a bendable wire.

16. The filtering device of claim 15, wherein the bendable wire is elastic and capable of expanding when subjected to a certain amount of force.

17. The filtering device of claim 16, wherein the bendable wire is resilient.

18. The filtering device of claim 7, wherein the intermediate link is resiliently expandable and contractible.

19. The filtering device of claim 7, wherein the proximal strut assembly includes two struts which move between the unexpanded position and the expanded position.

20. The filtering device of claim 7, wherein:

the proximal strut assembly and distal strut assembly are made with struts having a particular strut width and strut thickness and the intermediate links are made from a strut having a smaller strut thickness than the strut thickness of the proximal strut assembly or distal strut assembly.

21. The filtering device of claim 7, wherein:

the proximal strut assembly and distal strut assembly are made with struts having a particular strut width and strut thickness and the intermediate links are made from a strut having a smaller strut width than the strut width of the proximal strut assembly or distal strut assembly.

22. The filtering device of claim 7, wherein:

the proximal strut assembly and distal strut assembly are made with struts having a particular strut width and strut thickness and the intermediate links has both a strut width and strut thickness less than the strut width and strut thickness of the proximal strut assembly or distal strut assembly.

23. An embolic filtering device used to capture embolic debris in a body vessel, comprising:

a guide wire;

an expandable filter assembly associated with the guide wire, the filter assembly including a self-expanding basket having a proximal strut assembly adapted to move between an unexpanded position and an expanded position, a distal strut assembly adapted to move between an unexpanded position and an expanded position and a filter element having a proximal end with a proximal edge forming a proximal inlet opening and a plurality of distal outlet openings, the outlet openings allowing the body fluid to flow through the filter element but retaining embolic debris within the filter element, the proximal inlet opening being larger than the outlet openings and the proximal edge of the filter element being attached directly to the distal strut assembly, and a plurality of intermediate links connecting the proximal strut assembly to the distal strut assembly, wherein the intermediate links are expandable and contractible independent from any movement of the proximal and distal strut assemblies as the assemblies move between the expanded and unexpanded positions.

24. The filtering device of claim 23, wherein the filter assembly is rotatably mounted to the guide wire.

25. The filtering device of claim 23, further including means for maintaining the filter assembly in the unexpanded position until it is ready to be deployed into the expanded position.

26. The filtering device of claim 23, wherein the intermediate links are capable of expanding or contracting when subjected to a certain amount of force.

27. The filtering device of claim 23, wherein the intermediate links are made from a material different in composition than the proximal strut assembly and distal strut assembly.

28. The filtering device of claim 23, wherein each intermediate link is independently capable of expanding or contracting when subjected to a certain amount of force.

29. The filtering device of claim 23, wherein the intermediate links are resiliently expandable and contractible.

30. An embolic filtering device used to capture embolic debris in a body vessel, comprising:

a guide wire;

a filter assembly associated with the guide wire, the filter assembly including a basket having a proximal strut assembly and a distal strut assembly, each of the strut assemblies being adapted to move between an unexpanded position and an expanded position, an intermediate link connecting the proximal strut assembly to the distal strut assembly, wherein the basket has a particular longitudinal length which lengthens or shortens as the proximal and distal struts assemblies move between the unexpanded and expanded positions, the intermediate link being adapted to lengthen or shorten independent from movement of the proximal and distal strut assemblies between expanded and unexpanded positions; and

a filter element having a proximal end with a proximal edge forming a proximal inlet opening and a plurality of distal outlet openings, the outlet openings allowing the body fluid to flow through the filtering element but retaining embolic debris within the filtering element, the inlet opening being larger than the outlet openings, the proximal edge of the filter element being attached directly to the distal strut assembly of the basket.

31. The filtering device of claim 30, further including a plurality of intermediate links connecting the proximal strut assembly to the distal strut assembly.

32. The filtering device of claim 31, wherein the intermediate links are capable of lengthening or shortening when subjected to a certain amount of force.

33. The filtering device of claim 30, further including means for maintaining the filter assembly in the unexpanded position until it is ready to be deployed into the expanded position.

34. The filtering device of claim 30, wherein each intermediate link is independently capable of lengthening or shortening from each other.

35. The filtering device of claim 30, wherein the intermediate links are made from a material different in composition than the proximal strut assembly and distal strut assembly.

36. The filtering device of claim 30, wherein the intermediate links are resilient.

37. The filtering device of claim 30, wherein the proximal strut assembly is made from a self-expanding material.

38. The filtering device of claim 30, wherein the intermediate link is made from a self-expanding material.

39. An embolic filtering device used to capture embolic debris in a body vessel, comprising:

a guide wire;

a filter assembly carried by the guide wire, the filter assembly including;

a basket having a proximal strut assembly including a deployment ring movable between an unexpanded position and an expanded position, a distal strut assembly including a deployment ring movable between an unexpanded position and an expanded position, an intermediate link connecting the proximal strut assembly to the distal strut assembly; and

a filter element having a proximal end with a proximal edge forming a proximal inlet opening and a plurality of distal outlet openings, the outlet openings allowing the body fluid to flow through the filtering element but retaining embolic debris within the filtering element, the inlet opening being larger than the outlet openings, the proximal edge of the filter element being attached directly to the distal strut assembly of the basket.

40. The filtering device of claim 39, wherein the intermediate link has a nominal length which is capable of expanding or contracting when subjected to a certain amount of force.

41. The filtering device of claim 39, wherein the intermediate link is made from a different material than the proximal strut assembly and distal strut assembly.

42. The filtering device of claim 39, wherein the intermediate link is independently capable of expanding or contracting when subjected to a certain amount of force.

43. The filtering device of claim 39, wherein each intermediate link includes an S-shape portion.

44. The filtering device of claim 43, wherein the S-shape portion of the intermediate link is capable of expanding or contracting when subjected to a certain amount of force.

45. The filtering device of claim 39, wherein the intermediate link is made from a bendable wire.

46. The filtering device of claim 45, wherein the bendable wire is elastic and capable of expanding when subjected to a certain amount of force.

47. The filtering device of claim 39, wherein the intermediate link is attached to the deployment rings of the proximal and distal strut assemblies.