System and Method of Use for Revascularizing Stenotic Bypass Grafts and Other Blood Vessels

• US 20070118072A1
• Filed: 01/26/2007
• Published: 05/24/2007
• Est. Priority Date: 07/26/1996
• Status: Active Grant

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Nash, John
• Granted Patent: US 7,833,239 B2
• Time in Patent Office: Days
• US Class Current: 604/35
• 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'"'"'s vascular system. The system introduces an infusate liquid at a first flow rate to the occluded portion of the blood vessel, and withdraws that liquid and some blood at a second and higher flow rate. This action creates a differential flow in the occluded blood vessel portion and thereby prevent particles of occlusive material from flowing into any upstream blood vessel or downstream blood vessel in said living being'"'"'s vascular system.

Claims

1. A system for removing occlusive material from an occluded blood vessel portion of a living being'"'"'s vascular system, comprising:

an elongated flexible tubular body member having a free end adapted to be delivered intravascularly to the occluded blood vessel portion and deliver a jet of infusate liquid into said vessel to dislodge particles of said occlusive material;

an infusate pump for delivering said infusate liquid to said occluded blood vessel portion at an infusate flow rate; and

an aspiration pump for aspirating infusate liquid, blood and dislodged particles from the occluded blood vessel portion at an aspiration flow rate;

wherein said aspiration flow rate is greater than said infusate flow rate and said infusate and aspiration pumps are simultaneously operable to create a differential flow rate in said occluded blood vessel portion and thereby prevent particles of occlusive material from flowing into any upstream blood vessel or downstream blood vessel in said living being'"'"'s vascular system.

2. The system according to claim 1, further comprising a guide catheter.

3. The system according to claim 1, further comprising a collection vessel located outside the body of said living being.

4. The system according to claim 1, wherein the aspiration flow rate is in the range of 5 to 100 ml per minute.

5. The system according to claim 1, wherein the aspiration flow rate exceeds the infusion flow rate by between 5 and 50 percent.

6. The system according to claim 1, wherein said aspiration flow rate and said infusion flow rates are variable.

7. The system according to claim 1, wherein said infusate and aspiration pumps are piston pumps.

8. The system according to claim 1, wherein said infusate and aspiration pumps are peristaltic pumps.

9. The system according to claim 1, wherein said elongated flexible tubular body is adapted to direct said jet of liquid laterally toward the wall of said blood vessel.

10. The system according to claim 1, wherein said aspiration flow rate and said infusion flow rate are coordinated, so that a change in one flow rate automatically results in a proportional change in the other flow rate.

11. The system according to claim 1, further comprising an electrical controller for controlling said infusate flow rate and said aspiration flow rate.

12. The system according to claim 11, wherein said controller automatically coordinates said aspiration flow rate and said infusion flow rate, so that a change in one flow rate automatically results in a proportional change in the other flow rate.

13. A method for removing occlusive material from an occluded blood vessel portion of a living being'"'"'s vascular system, comprising:

providing a system comprising;

(i) an elongated flexible tubular body member having a free end adapted to be delivered intravascularly to the occluded blood vessel portion and deliver a jet of infusate liquid into said vessel to dislodge particles of said occlusive material;

(ii) an infusate pump for delivering said infusate liquid, at an infusate flow rate; and

(iii) an aspiration pump for aspirating infusate liquid, blood and occlusive material from the occluded blood vessel portion at an aspiration flow rate;

simultaneously aspirating infusate liquid, blood and dislodged particles from the occluded blood vessel portion at an aspiration flow rate that is greater than said infusate flow rate to create a differential flow rate in said occluded blood vessel portion and thereby prevent particles of occlusive material from flowing into any upstream blood vessel or downstream blood vessel in said living being'"'"'s vascular system.

14. The method according to claim 13, wherein the infusate liquid contains a therapeutic drug.

15. The method according to claim 13, wherein the infusate liquid contains a contrast medium.

16. The method according to claim 13, wherein the aspiration flow rate is in the range of 5 to 100 ml per minute.

17. The method according to claim 13, wherein the aspiration flow rate exceeds the infusion flow rate by between 5 and 50 percent.

18. The method according to claim 13, wherein said aspiration flow rate and said infusion flow rates are variable.

19. The method according to claim 13, wherein said aspiration flow rate and said infusion flow rate are coordinated, so that a change in one flow rate automatically results in a proportional change in the other flow rate.

20. The method according to claim 13, wherein said system further comprises an electrical controller for controlling said infusate flow rate and said aspiration flow rate.

21. The method according to claim 20, wherein said controller automatically coordinates said aspiration flow rate and said infusion flow rate, so that a change in one flow rate automatically results in a proportional change in the other flow rate.

22. The method according to claim 13, wherein said infusate and aspiration pumps are piston pumps.

23. The method according to claim 13, wherein said infusate and aspiration pumps are peristaltic pumps.

24. The method according to claim 13, wherein said elongated flexible tubular body is adapted to direct said jet of liquid laterally toward the wall of said blood vessel.

25. A system for removing occlusive material from a blood vessel portion of a living being'"'"'s vascular system comprising:

an elongated flexible tubular body member adapted to be delivered intravascularly to the occluded portion of a blood vessel;

an infusate pump for delivery an infusate liquid at an infusate flow rate into said blood vessel; and

an aspiration pump for aspirating said infusate liquid and said occlusive material at an aspiration flow rate,

wherein said infusate flow rate is less than said aspiration flow rate, and wherein said rates serve to prevent embolization of said occlusive material in the living being'"'"'s vascular system.

26. The system of claim 25 wherein said tubular body member is arranged to deliver said infusate liquid in the form of a liquid jet that serves to dislodge particles of said occlusive material to open the lumen.

27. The system of claim 26 wherein said tubular body member comprises a working head arranged to dislodge particles of said occlusive material.

28. The system of claim 27 wherein said working head is arranged to deliver said infusate liquid in the form of a jet.

29. The system of claim 25 wherein said infusate comprises at least one of a contrast medium, a drug, or an oxygenated fluid.

30. The system of claim 29, wherein the drug is heparin or urokinase.

31. The system of claim 25 wherein said tubular body member is arranged to act on the occlusive material to produce debris.

32. The system of claim 31 wherein said tubular body member comprises an atherectomy device or a thrombolectomy device.

33. The system of claim 25 wherein said infusate flow rate and said aspiration flow rate are coordinated, such that a change in one flow rate automatically causes a proportional change in the other flow rate.

34. The system of claim 33 further comprising a mechanical linkage between said infusate pump and said aspiration pump.