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

• US 5,779,721 A
• Filed: 07/26/1996
• Issued: 07/14/1998
• 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:
  US08/690,438
• Time in Patent Office: 718 Days
• Field of Search: 606/159, 606/170, 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'"'"'s vascular system. The system comprises an instrument having a working head, e.g., a rotary impacting impeller located within an apertured shroud, and a debris extraction sub-system. The instrument 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 by the operation of the working head on the occlusive material. The debris extraction sub-system introduces an infusate liquid at a first flow rate adjacent the working head, e.g., through a opening in the shroud, and withdraws that liquid and some blood at a second and higher flow rate, e.g., through the guide catheter. This action creates a differential flow adjacent the working head, whereupon debris produced by the operation of the working head is withdrawn in the infusate liquid and blood by the differential flow for collection outside the being'"'"'s body. The introduction of the infusate liquid establishes an unbalanced flow adjacent the working head to enable the catheter to be steered hydrodynamically.

Claims

1. An intravascular system for opening a lumen in an occluded blood vessel portion of a living being'"'"'s vascular system, the occluded blood vessel portion being occluded by an occlusive material, said system comprising an instrument and debris extraction means, said instrument having an exterior surface and a working head and being arranged to be located within the being'"'"'s vascular system, whereupon a passageway is established outside said exterior surface of said instrument and within the being'"'"'s vascular system, said working head being arranged to operate on the occlusive material in the interior of the occluded blood vessel portion to open a lumen therein for the flow of blood therethrough, whereupon some debris may be produced from the occlusive material by the operation of said working head, said debris extraction means introducing an infusate liquid at a first flow rate adjacent said working head and withdrawing said liquid at a second and higher flow rate through said passageway to create a differential flow adjacent said working head, whereupon debris produced by the operation of said working head is withdrawn through said passageway 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 establishes a vortex flow that circulates locally adjacent the working head.

4. The intravascular system of claim 3 wherein said working head comprises an impeller which establishes said vortex flow adjacent said working head.

5. The intravascular system of claim 4 wherein said impeller is a rotary member and wherein debris produced by the operation of said working head is in the form of particles which are carried by said vortex flow into repeated engagement with said impeller to reduce the size of such particles.

6. The intravascular system of claim 4 wherein said impeller is located within a shroud, said shroud having at least one opening through which said vortex flow passes.

7. The intravascular system of claim 1 wherein said working head is arranged to mechanically engage the occlusive material to open the lumen therein.

8. The intravascular system of claim 7 wherein said working head is an impacting member.

9. The intravascular system of claim 8 wherein said working head is a rotary member.

10. The intravascular system of claim 9 additionally comprising a flexible drive shaft coupled to said working head for effecting the rotation of said working head at a high rate of speed.

11. The intravascular system of claim 10 additionally comprising motor means for effecting the rotation of said flexible drive shaft.

12. The intravascular system of claim 1 wherein said instrument is arranged to introduce said infusate liquid at said first flow rate adjacent said working head.

13. The intravascular system of claim 12 wherein the first and second flow rates are adjustable.

14. The intravascular system of claim 12 wherein said instrument is arranged to be located within said catheter to form said passageway between said instrument and said catheter, said infusate liquid and the debris therein being withdrawn from the occluded blood vessel through said passageway.

15. The intravascular system of claim 14 wherein said debris extraction means comprises first pump means coupled to said instrument for establishing said first flow rate and second pump means coupled to said catheter for establishing said second flow rate.

16. The intravascular system of claim 12 wherein said system establishes a vortex flow that circulates locally adjacent the working head.

17. The intravascular system of claim 12 wherein said working head is a rotary member.

18. The intravascular system of claim 17 wherein said rotary member comprises an impeller which establishes a vortex flow that circulates locally adjacent the working head.

19. The intravascular system of claim 12 wherein said debris extraction means includes means for correlating said first and second flow rates to each other.

20. The intravascular system of claim 19 wherein said means for correlating enables said each of said first and second flow rates to be adjustable.

21. The intravascular system of claim 1 additionally comprising hydrodynamic steering means for steering said working head.

22. The intravascular system of claim 21 wherein said hydrodynamic steering means comprises a portion of said instrument and is located adjacent the working head, said instrument being arranged to be rotated about its central longitudinal axis to bring said hydrodynamic steering means to a desired orientation with respect to the central longitudinal axis of the blood vessel in which said instrument is located.

23. The intravascular system of claim 22 wherein said instrument has a distal end portion at which said working head is located and wherein said hydrodynamic steering means produces an unbalanced flow of fluid with respect to said instrument to propel said distal end portion of said instrument laterally of the central longitudinal axis of the blood vessel in which it is located.

24. The intravascular system of claim 23 wherein said instrument comprises a rotating working head located within a shroud, said shroud including at least one side directed window therein, said window forming at least one port of said hydrodynamic steering means.

25. The intravascular system of claim 24 wherein said rotary working head is arranged to impact the occlusive material to produce the lumen therethrough.

26. The intravascular system of claim 25 wherein said rotary working head is arranged to impact the occlusive material to produce the lumen therethrough.

27. The intravascular system of claim 26 wherein said instrument is arranged to be rotated about its central longitudinal axis to bring said window to a desired orientation with respect to the central longitudinal axis of the blood vessel in which said instrument is located.

28. The intravascular system of claim 25 wherein said instrument is arranged to be rotated about its central longitudinal axis to bring said window to a desired orientation with respect to the central longitudinal axis of the blood vessel in which said instrument is located.

29. The intravascular system of claim 21 wherein said instrument has a distal end portion at which said working head is located and wherein said hydrodynamic steering means produces an unbalanced flow of fluid with respect to said instrument to propel said distal end portion of said instrument laterally of the central longitudinal axis of the blood vessel in which it is located.

30. The intravascular system of claim 29 wherein said instrument comprises a rotating working head located within a shroud, said shroud including at least one side directed window therein, said window forming at least one port of said hydrodynamic steering means.

31. The apparatus of claim 1 wherein said system additionally comprises a tubular member arranged for introduction into the being'"'"'s vascular system adjacent the occluded blood vessel portion, said instrument being arranged to be disposed within said tubular member to establish said passageway between said tubular member and said instrument.

32. The apparatus of claim 31 wherein said tubular member is arranged to introduce and guide said working head of said instrument to a position adjacent the occlusive material.

33. An intravascular system for opening a lumen in an occluded blood vessel portion of a living being'"'"'s vascular system, said occluded blood vessel portion being occluded by an occlusive material, said system comprising an instrument, a catheter and debris extraction means, said instrument including a working head, said instrument being located within said catheter, said working head being arranged to operate on the occlusive material in the interior of the occluded blood vessel portion to open a lumen therein for the flow of blood therethrough, whereupon some debris may be produced from the occlusive material by the operation of said working head, said debris extraction means including debris removal means coupled to said catheter, said debris extraction means being arranged for introducing an infusate liquid through said instrument at a first flow rate to a position adjacent said working head, said debris extraction being also being arranged for withdrawing said liquid at a second and higher flow rate to create a differential flow adjacent said working head, whereupon debris produced by the operation of said working head 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, said infusate liquid and the debris therein being withdrawn from the occluded blood vessel portion through said passageway under the influence of said debris removal means.

34. The intravascular system of claim 33 wherein said catheter comprises a guide catheter.

35. The intravascular system of claim 33 wherein said catheter comprises an introducer sheath.

36. The intravascular system of claim 33 wherein the first and second flow rates are correlated to each other.

37. The intravascular system of claim 36 wherein said first and second flow rates are adjustable.

38. The intravascular system of claim 33 wherein said debris extraction means comprises first pump means coupled to said instrument for establishing said first flow rate and wherein said debris removal means comprises second pump means for establishing said second flow rate.

39. The intravascular system of claim 38 wherein said first and second pump means are each positive displacement pumps.

40. The intravascular system of claim 33 wherein said instrument and said catheter are each sufficiently flexible to be passed longitudinally through a portion of the vascular system so that said working head is located adjacent the occluded blood vessel portion.

41. A method for opening a lumen in an occluded blood vessel portion of a living being'"'"'s vascular system located downstream of a first blood vessel portion from which blood will flow to the occluded blood vessel portion, the occluded blood vessel portion being occluded by an occlusive material and being located upstream of a second blood vessel portion, said method comprising:

(a) providing a working head and debris extraction means within the being'"'"'s vascular system,

(b) operating said working head on the occlusive material in the interior of the occluded blood vessel portion to open a lumen for the flow of blood therethrough to said second blood vessel portion, whereupon some debris may be produced from the occlusive material by the operation of said working head,

(c) causing said debris extraction means to introduce an infusate liquid at a first flow rate adjacent said working head, and

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

42. The method of claim 41 wherein said differential flow prevents debris produced by the operation of said working head from flowing into either the first blood vessel portion or the second blood vessel portion.

43. The method of claim 42 wherein said occluded blood vessel portion comprises a bypass graft.

44. The method of claim 43 wherein the bypass graft is a coronary bypass graft, wherein said living being'"'"'s vascular system includes an aorta, and wherein the first vessel portion comprises the aorta.

45. The method of claim 43 wherein said living being'"'"'s vascular system includes a femoral artery and wherein the occluded blood vessel portion comprises a portion of the femoral artery.

46. The method of claim 45 wherein said living being'"'"'s vascular system includes a profunda femoris and wherein the first blood vessel portion comprises the profunda femoris.

47. The method of claim 41 additionally comprising:

(d) establishing a vortex flow that circulates locally adjacent said working head.

48. The method of claim 41 wherein said working head is arranged to engage the occlusive material to open the lumen therein.

49. The method of claim 48 wherein said working head is a rotary member which is rotated to cause to repeatedly engage the occlusive material to open the lumen therein.

50. The method of claim 49 wherein the repeated engagement causes portions of the occlusive material to be removed to produce the lumen therethrough.

51. The method of claim 49 wherein said repeated engagement comprises repeated impacting of the occlusive material, to break portions of the occlusive material away to produce the lumen.

52. The method of claim 50 additionally comprising:

(d) establishing a vortex flow that circulates locally adjacent said working head.

53. The method of claim 50 wherein said vortex flow carries removed portion of the occlusive material into repeated engagement with said working.