System and method of use for revascularizing stenotic bypass grafts and other blood vessels

• US 5,938,672 A
• Filed: 01/13/1998
• Issued: 08/17/1999
• Est. Priority Date: 07/26/1996
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Nash, John E.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/006,910
• Time in Patent Office: 581 Days
• Field of Search: 606/159, 606/170, 606/167, 606/180, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22048 Balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2205/05 combined with other kinds of therapy
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 5/14232 Roller pumps

Abstract

A system and method for opening a lumen in an occluded blood vessel, e.g., a coronary bypass graft, of a living being. The system comprises an atherectomy catheter having a working head, e.g., a rotary impacting impeller, and a debris extraction sub-system. The atherectomy catheter is located within a guide catheter. The working head is arranged to operate on, e.g., impact, the occlusive material in the occluded vessel to open a lumen therein, whereupon some debris may be produced. The debris extraction sub-system introduces an infusate liquid at a first flow rate adjacent the working head and withdraws that liquid and some blood at a second and higher flow rate, through the guide catheter to create a differential flow adjacent the working head, whereupon the debris is withdrawn in the infusate liquid and blood for collection outside the being'"'"'s body. The introduction of the infusate liquid may also be used to establish an unbalanced flow adjacent the working head to enable the atherectomy catheter to be steered hydrodynamically. A guide wire having an inflatable balloon on its distal end may be used with the atherectomy catheter to block the flow of debris distally, while enabling distal tissues to be perfused with an oxygenating liquid.

Claims

1. An intravascular system for opening a lumen in a portion of an occluded blood vessel of a living being'"'"'s vascular system, said occluded blood vessel portion being occluded by an occlusive material, said system comprising a lumen-opening member for introduction into the lumen of the blood vessel portion, debris blocking means, and debris extraction means, said lumen-opening member being arranged to act on the occlusive material in the interior of the occluded blood vessel portion to open the lumen for the freer flow of blood therethrough, whereupon some debris may be produced from the occlusive material by the action of said lumen-opening member, said debris blocking means being arranged to be located within the occluded blood vessel distally of said lumen opening member for preventing debris from flowing distally of said debris blocking means, said debris extraction means introducing an infusate liquid at a first flow rate adjacent said member and withdrawing said liquid at a second and higher flow rate to create a differential flow adjacent said lumen-opening member, whereupon debris produced by the action of said lumen-opening member is withdrawn by said differential flow for collection remote from the occluded vessel portion and is prevented from flowing into any upstream blood vessel or downstream blood vessel.

2. The intravascular system of claim 1 wherein the first and second flow rates are adjustable.

3. The intravascular system of claim 1 wherein said system comprises a catheter, said infusate liquid and the debris therein being withdrawn from the occluded blood vessel portion through said catheter.

4. The intravascular system of claim 1 wherein the first and second flow rates are correlated to each other.

5. The intravascular system of claim 4 wherein said first and second flow rates are adjustable.

6. The intravascular system of claim 1 wherein said lumen-opening member is tubular.

7. The intravascular system of claim 6 wherein said lumen-opening member comprises an elongated tubular instrument having distal end including a working head.

8. The intravascular system of claim 7 wherein said working head comprises a movable impacting member.

9. The intravascular system of claim 8 wherein said working head is rotatable.

10. A method for opening a lumen in a portion of an occluded blood vessel of a living being'"'"'s vascular system, the occluded blood vessel portion being occluded by an occlusive material, said method comprising:

(a) providing a lumen-opening member into the lumen in the occluded blood vessel portion;

(b) providing debris extraction means within the being'"'"'s vascular system adjacent said lumen-opening member;

(c) providing debris blocking means within the blood vessel-distally of said lumen opening member;

(d) causing said lumen-opening member to act on the occlusive material in the interior of the occluded blood vessel portion to open the lumen for the freer flow of blood therethrough, whereupon some debris may be produced from the occlusive material by the action of said member;

(e) causing said debris extraction means to introduce an infusate liquid at a first flow rate adjacent said member; and

(f) causing said debris extraction means to withdraw said liquid at a second and higher flow rate to create a differential flow adjacent said member, whereupon debris produced by the operation of said member is withdrawn for collection remote from the occluded blood vessel portion and whereupon said debris blocking means blocks debris from flowing distally of said debris blocking means.

11. The method of claim 10 wherein said occluded blood vessel portion comprises a bypass graft.

12. The method of claim 11 wherein said bypass graft is a coronary bypass graft.

13. The method of claim 11 wherein said differential flow prevents debris produced by the action of said member from flowing into either the a first blood vessel portion or a second blood vessel portion.

14. The method of claim 13 wherein said occluded blood vessel portion comprises a bypass graft.

15. The method of claim 14 wherein said bypass graft is a coronary bypass graft and wherein said first vessel portion comprises the aorta.

16. The method of claim 14 wherein said occluded blood vessel portion comprises a portion of the femoral artery.

17. The method of claim 14 wherein said first blood vessel portion comprises the profunda femoris.

18. The method of claim 10 wherein said occluded blood vessel portion comprises a portion of an artery.

19. The method of claim 18 wherein said artery is a coronary artery.

20. The method of claim 18 wherein said artery is a femoral artery.

21. An intravascular system for opening a lumen in a portion of an occluded blood vessel of a living being'"'"'s vascular system, said occluded blood vessel portion being occluded by an occlusive material, said system comprising a catheter, a lumen-opening member, and debris extraction means, said catheter having a longitudinal passageway extending at least partially therethrough, said lumen-opening member being arranged for introduction through said passageway into the lumen of the blood vessel portion to act on the occlusive material in the interior of the occluded blood vessel portion to open the lumen for the freer flow of blood therethrough, whereupon some debris may be produced from the occlusive material by the action of said lumen-opening member thereon, said debris extraction means introducing an infusate liquid at a first flow rate adjacent said lumen-opening member and withdrawing said liquid at a second and higher flow rate through said passageway of said catheter to create a differential flow adjacent said lumen-opening member, whereupon debris produced by the action of said lumen-opening member on the occlusive material is withdrawn by said differential flow through said passageway for collection remote from the occluded vessel portion and is prevented from flowing into any upstream blood vessel or downstream blood vessel.

22. The intravascular system of claim 21 wherein the first and second flow rates are adjustable.

23. The intravascular system of claim 21 wherein said system comprises a catheter, said infusate liquid and the debris therein being withdrawn from the occluded blood vessel portion through said catheter.

24. The intravascular system of claim 23 wherein the first and second flow rates are correlated to each other.

25. The intravascular system of claim 24 wherein said first and second flow rates are adjustable.

26. The intravascular system of claim 21 wherein said lumen-opening member is tubular.

27. The intravascular system of claim 26 wherein said lumen-opening member comprises an elongated tubular instrument having distal end including a working head.

28. The intravascular system of claim 27 wherein said working head comprises a movable impacting member.

29. The intravascular system of claim 28 wherein said working head is rotatable.