Catheter apparatus for treating occluded vessels and filtering embolic debris and method of use

• US 6,761,732 B2
• Filed: 09/27/2002
• Issued: 07/13/2004
• Est. Priority Date: 12/30/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Burkett, David H., Kokish, Arkady, Wang, Chicheng
• Primary Examiner(s): Bui, V
• Application Number:
  US10/259,920
• Publication Number:
  US 20030028238A1
• Time in Patent Office: 655 Days
• Field of Search: 623/1-1-, 606/108, 606/159, 606/200, 606/191, 606/192, 606/194, 606/195, 606/198, 604/96-97, 604/104-108
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A catheter apparatus includes a lesion dilating member disposable at a lesion position in a vessel (e.g. a patient'"'"'s artery) which is dilatable to open the vessel at the lesion position. An emboli-capturing assembly having a perfusion member and filter is displaced downstream from the lesion dilating member to capture embolic debris released in the fluid flow. The perfusion member may illustratively have peaks and channels formed between adjacent peaks which cooperate with the filter to create trapping pockets that capture embolic debris. The filter may be made from any flexible and porous material with dimensions to pass the fluid and block the emboli. The perfusion member is thereafter deflated to provide for emboli retention in the perfusion member.

Claims

1. A catheter apparatus for treating a lesion-blocked vessel and capturing emboli in a fluid flowing in the vessel, comprising:

a lesion dilating member for disposition in the vessel at the position of the lesion blockage, the lesion dilating member being expandable to open the vessel at the position of the lesion, and

a perfusion member and a filter for disposition in the vessel at a position displaced from the lesion, the perfusion member having proximal and distal ends with the filter attached to the outer surface of the perfusion member at a location distal to the proximal end of the perfusion member, wherein

the outer surface of the perfusion member has a plurality of annularly spaced peaks to define channels formed between adjacent peaks and the filter to allow the flow of the fluid and the filter is made from a material which allows the fluid to pass but not emboli.

2. The catheter apparatus of claim 1 wherein the distance between the peaks and the bottoms of the channels at the start of the coverage of the filter is less than the distance between the peaks and the bottoms of the channels at the distal end of the perfusion member.

3. The catheter apparatus of claim 1 wherein the perfusion member is expandable from a collapsed to an expanded position.

4. The catheter apparatus of claim 1 wherein the perfusion member is an expandable member.

5. The catheter apparatus of claim 4 wherein the expandable member is a balloon.

6. The catheter apparatus of claim 1 wherein the filter coverage starts substantially near the center of the perfusion member.

7. The catheter apparatus of claim 1 wherein each channel of the perfusion member has a particular depth.

8. The catheter apparatus of claim 7 wherein the depth of the channel varies along the length of the perfusion member.

9. An emboli-capturing device for capturing emboli released into the fluid of a body vessel, comprising:

a perfusion member having proximal and distal ends and a filter attached to the outer surface of the perfusion member at a location distal to the proximal end of the perfusion member, wherein

the outer surface of the perfusion member has a plurality of annularly spaced peaks to define channels formed between adjacent peaks and the filter to allow the flow of the fluid and the filter is made from a material which allows the fluid to pass but not emboli.

10. The emboli-capturing device of claim 9 wherein the distance between the peaks and the bottoms of the channels at the start of the coverage of the filter is less than the distance between the peaks and the bottoms of the channels at the distal end of the perfusion member.

11. The catheter apparatus of claim 9 wherein the perfusion member is expandable from a collapsed to an expanded position.

12. The catheter apparatus of claim 9 wherein the perfusion member is an expandable member.

13. The catheter apparatus of claim 12 wherein the expandable member is a balloon.

14. The catheter apparatus of claim 9 wherein the filter coverage starts substantially near the center of the perfusion member.

15. The catheter apparatus of claim 9 wherein each channel of the perfusion member has a particular depth.

16. The catheter apparatus of claim 9 wherein the depth of the channel varies along the length of the perfusion member.

17. The catheter apparatus of claim 9 wherein the filter is bonded to the peaks of the perfusion member.

18. A method of opening a vessel, at least partially blocked, to pass a fluid in the vessel and to capture emboli from the fluid, comprising the steps

providing a lesion dilating member and a perfusion member and a filter, all attached to a catheter at displaced positions in the direction of the fluid flow,

the lesion dilating member being constructed to be disposed at the position of the lesion in the vessel and being expandable to open the vessel at the position of the lesion and being collapsible after opening the vessel,

the outer surface of the perfusion member having a plurality of annularly spaced peaks and channels formed between adjacent peaks and the perfusion member being constructed to be disposed after the lesion in the direction of the fluid flow and to provide for the flow of the fluid through the channels, the perfusion member being expandable and collapsible,

the filter being attached to the outer surface of the perfusion member to form a pocket with each channel and constructed to pass the fluid and to block the passage of the emboli,

disposing the catheter in the vessel, the lesion dilating member and perfusion member being collapsed with the lesion dilating member in juxtaposition to the lesion and with the perfusion balloon and the filter distal from the lesion in the direction of the fluid flow,

expanding the perfusion member,

expanding the lesion dilating member,

collapsing the lesion dilating member, and

collapsing the perfusion member.

19. The method of claim 18 wherein the distance between the peaks and the bottoms of the channels at the start of the coverage of the filter is less than the distance between the peaks and the bottoms of the channels at the distal end of the perfusion member.

20. The method of claim 18 wherein the perfusion member is a balloon.

21. The method of claim 18 wherein each channel of the perfusion member has a particular depth.

22. The method of claim 21 wherein the depth of the channel varies along the length of the perfusion member.

23. The method of claim 18, including the step of:

removing the catheter, the lesion dilating member and the perfusion member and the filter from the vessel after collapsing the lesion dilating member and perfusion member.

24. In a method of opening a vessel, at least partially blocked, to pass a fluid in the vessel and to prevent emboli from the fluid, the steps of:

attaching a perfusion member and a filter to a catheter, the perfusion member being inflatable and deflatable, an outer surface of the perfusion member having a plurality of annularly spaced peaks to define channels formed between adjacent peaks and the filter, the filter being disposed on the perfusion member and being distal from the perfusion member in the direction of the fluid flow,

the perfusion member being constructed in the inflatable relationship to pass the fluid to the filter and to retain the emboli after the passage of the emboli partially through the filter, the filter being constructed to retain the emboli and pass the fluid,

the perfusion member being constructed in the deflatable relationship to block the passage of the emboli,

disposing the catheter and the perfusion member and the filter in the vessel with the perfusion member and the filter distal from the lesion in the direction of the fluid flow,

initially inflating the perfusion member before enlarging the vessel at the position of the lesion,

retaining the perfusion member in the inflated relationship during the enlargement of the vessel at the position of the lesion, and

deflating the perfusion member a particular time after the enlargement of the vessel at the position of the lesion.

25. The method of claim 24, wherein

the perfusion member has proximal and distal ends,

the perfusion member is provided with undulations providing variations in depth at progressive annular positions, the depth of the undulations in the perfusion member in the inflated relationship of the perfusion member being less than the depth of the undulations in the perfusion member in the deflated relationship of the perfusion member,

the depth of the undulations in the perfusion member increases with progressive amounts of deflation of the perfusion member to prevent the emboli from passing from the perfusion member in the deflated relationship of the perfusion member.

26. The method of claim 24, wherein

the perfusion member is provided with peaks at annularly spaced positions and with channels formed between adjacent peaks and the distance between the peaks and the channels in the perfusion member in the inflated relationship of the perfusion member being less than the distance between the peaks and the channels in the perfusion member in the deflated relationship of the perfusion member to provide for a retention of the emboli in the perfusion member in the deflated relationship of the perfusion member,

the perfusion member has proximal and distal ends,

the distance between the peaks and the channels at the proximal end of the perfusion member in the inflated relationship of the perfusion member is less than the distance between the peaks and the troughs in the perfusion member at the distal end of the perfusion member in the inflated relationship of the perfusion member.

27. The method of claim 25, wherein

the filter is made from a material having pores with dimensions to pass the fluid but not the emboli and the filter being bonded to the perfusion member, and further including the step of,

removing the catheter and the perfusion member and filter from the vessel after the deflation of the perfusion member.

28. The method of claim 26, wherein

the filter is made from a material having pores with dimensions to pass the fluid but not the emboli and the filter being bonded to the perfusion member, and including the step of

removing the catheter and the perfusion member and the filter from the vessel after the deflation of the perfusion member.