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

• US 5,997,558 A
• Filed: 11/02/1998
• Issued: 12/07/1999
• 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:
  US09/183,991
• Time in Patent Office: 400 Days
• Field of Search: 606/159, 606/169, 606/170, 606/180, 606/167, 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, the occluded blood vessel portion being occluded by occlusive material and being located distally of a patent blood vessel portion, said system comprising a guide catheter, a lumen-opening catheter, a debris blocking member, and a fluid flow system, said lumen-opening catheter having a working head for introduction through the guide catheter into the lumen of the occluded blood vessel portion, whereupon a fluid-flow passageway is established between said guide catheter and said lumen-opening catheter, said working head being operative for operating on the occlusive material in the interior of the occluded blood vessel portion, whereupon some debris may be produced, said debris blocking member being located distally of said working head to prevent debris from flowing distally thereof, said fluid flow system introducing an infusate liquid at a first flow rate adjacent said working head and withdrawing said liquid through said fluid-flow passageway at a second and higher flow rate to create a differential flow adjacent said working head, whereupon debris is withdrawn by said differential flow and flows with said liquid proximally through said fluid-flow passageway for extraction, said guide catheter being arranged to enable blood within the patent blood vessel portion to enter into said fluid-flow passageway for merger with said liquid and the debris.

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

3. The intravascular system of claim 1 wherein said working head comprises a movable impacting member.

4. The intravascular system of claim 3 wherein said first and second flow rates are adjustable.

5. The intravascular system of claim 3 wherein said working head is rotatable.

6. The intravascular system of claim 1 wherein said guide catheter has a distal end portion having an opening therein to enable blood within the patent blood vessel portion to enter through said opening into said fluid-flow passageway for merger with said liquid and the debris.

7. 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, the occluded blood vessel portion being located distally of a patent blood vessel portion, said method comprising:

(a) extending a guide catheter through said patent blood vessel portion into said occluded blood vessel portion;

(b) extending a lumen-opening catheter having a working head through said guide catheter so that said working head is located in the lumen in the occluded blood vessel portion, said guide catheter and said lumen-opening catheter defining a fluid-flow passageway therebetween;

(c) operating said working head to open the lumen for the freer flow of blood therethrough,

(d) blocking the flow of blood and debris distally of said working head;

(e) introducing an infusate liquid at a first flow rate adjacent said working head and withdrawing said liquid at a second and higher flow rate to create a differential flow adjacent said working head, whereupon debris is withdrawn with said liquid for passage proximally through said fluid-flow passageway; and

(f) providing a path for blood within the patent blood vessel portion to flow into said fluid-flow passageway for merger with said liquid and the debris.

8. The method of claim 7 wherein said occluded blood vessel portion comprises a bypass graft.

9. The method of claim 7 wherein said occluded blood vessel portion comprises a portion of the femoral artery.

10. The method of claim 7 wherein said guide catheter has a distal end portion having an opening therein to enable blood within the patent blood vessel portion to enter through said opening into said fluid-flow passageway for merger with said liquid and the debris.