Expandable atherectomy catheter device

• US 5,030,201 A
• Filed: 11/24/1989
• Issued: 07/09/1991
• Est. Priority Date: 11/24/1989
• Status: Expired due to Term

• Current Assignee: Aubrey Palestrant
• Original Assignee: Aubrey Palestrant
• Inventors: Palestrant, Aubrey
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): TSO, LAURA K
• Application Number:
  US07/441,655
• Time in Patent Office: 592 Days
• Field of Search: 604/22, 604/27, 604/28, 604/51, 604/52, 604/53, 606/167, 606/168, 606/170, 606/194, 128/751, 128/755
• US Class Current: 604/22
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22074 the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel

Abstract

An expandable atherectomy catheter device includes an expandable cutting head consisting of deformable cutting members to remove an atheroma or blood clot from a blood vessel. The cutting members, consisting of wires or blades, extend parallel to each other and are supported at the distal end of a rotatable catheter. A retraction member is slidingly disposed within the rotatable catheter and is coupled at its distal end to the cutting members; the retraction member can be manipulated from the proximal end thereof to adjust compression of the cutting members, and hence, the diameter of the cutting head. A motor is coupled to the proximal end of the rotatable catheter for rotating the cutting head to remove the atheromatous plaque or blood clot. A non-rotatable delivery catheter is inserted percutaneously within the blood vessel, and the distal end thereof is positioned proximate the site of the obstruction. The rotatable catheter extends within the delivery catheter, and the cutting head of the rotatable catheter is expanded upon being advanced to the site of the obstruction. Apparatus for aspirating the removed plaque or blood clot is also provided.

Claims

1. An expandable atherectomy device for removing atheroma or blood clots from a blood vessel, comprising in combination:

a. a first catheter having a distal end to be inserted into a blood vessel and having an opposing proximal end, said first catheter extending along a central longitudinal axis, said first catheter being flexible for allowing said atherectomy device to be guided through a blood vessel, said first catheter having a central lumen of a predetermined internal diameter extending from the proximal end thereof to the distal end thereof;

b. at least one elongated cutting member supported by the distal and of said first catheter and extending generally parallel to the longitudinal axis of said first catheter;

c. expansion means coupled to said at least one cutting member and extending through the central lumen of said first catheter for selectively expanding said at least one elongated cutting member away from the longitudinal axis of said first catheter;

d. a motor coupled to the proximal end of said first catheter for rotating said first catheter and said at least one cutting member to remove atheromatous material or a blood clot from a blood vessel; and

e. one of said first catheter and said expansion means including means for permitting fluids to be passed within said first catheter between the proximal end of said first catheter and the distal end thereof.

2. An expendable atherectomy device as recited by claim 1 including a plurality of elongated cutting members supported by the distal end of said first catheter and each extending generally parallel to the longitudinal axis of said first catheter and spaced apart from one another about said longitudinal axis, each of said plurality of elongated cutting members being coupled to said expansion means for being selectively expanded away from the longitudinal axis of said first catheter, and each of said plurality of elongated cutting members being rotated by said motor to remove an atheromatous material or a blood clot from a blood vessel.

5. An expandable atherectomy device as recited by claim 1 including a delivery catheter having a distal end to be inserted into a blood vessel and having an opposing proximal end, the distal end of said first catheter being adapted to be inserted into said delivery catheter through the proximal end thereof and advanced therethrough to the distal end thereof.

3. An expandable atherectomy device as recited by claim wherein said plurality of elongated cutting members each have first and second opposing ends, the first ends of said plurality of elongated cutting members being coupled in common to the distal end of said first catheter, the second ends of said plurality of elongated cutting members being coupled in common to said expansion means, said expansion means selectively compressing the first ends and second ends of said plurality of elongated cutting members together for causing each of said plurality of elongated cutting members to bow outwardly away from the longitudinal axis of said first catheter.

4. An expandable atherectomy device as recited by claim 3 wherein said expansion means adjustably compresses the first ends and second ends of said plurality of elongated cutting members for adjustably varying the outward bowing of said plurality of elongated cutting members.

6. An expandable atherectomy catheter device for removing atheroma or blood clots from a blood vessel, comprising in combination:

a. a first rotatable catheter having a distal end to be inserted into a blood vessel and having an opposing proximal end, said first rotatable catheter extending along a central longitudinal axis, said first catheter being flexible for allowing said atherectomy device to be guided through a blood vessel, said first catheter having a central lumen of a predetermined internal diameter extending from the proximal end thereof to the distal end thereof;

b. at least one elongated cutting member extending generally parallel to the central longitudinal axis of said first rotatable catheter, said cutting member having first and second opposing ends, the first end of said at least one cutting member being coupled to the distal end of said first catheter, said at least one cutting member being flexible to bow outwardly away from the central longitudinal axis of said first catheter when the first and second ends of said at least one cutting member are compressed;

c. an elongated flexible retractor member generally disposed within said first catheter and extending through the central lumen of said first catheter and extending generally along the central longitudinal axis thereof for sliding movement therein, said retractor member having a distal end coupled to the second end of said at least one cutting member and having an opposing proximal end;

d. adjustment means coupled to the proximal ends of said first catheter and said retractor member for adjusting the relative positions of the proximal ends of said first catheter and said retractor member along the central longitudinal axis of said first catheter, and thereby adjusting the distance between the first and second ends of said at least one cutting member for adjusting the amount by which said at least one cutting member bows outwardly;

e. a motor coupled to the proximal end of said first catheter for rotating said first catheter and said at least one cutting member to remove atheromatous material or a blood clot from a blood vessel; and

f. one of said first catheter and said retractor member including means for permitting fluids to be passed within said first catheter between the proximal end of said first catheter and the distal end thereof.

7. An expandable atherectomy catheter device as recited by claim 6 including a plurality of elongated cutting members supported by the distal end of said first catheter and each extending generally parallel to the longitudinal axis of said first catheter and spaced apart from one another about said longitudinal axis, each of said plurality of elongated cutting members having first and second opposing ends, the first end of each said cutting member being coupled to the distal end of said first catheter, each of said cutting members being flexible to bow outwardly away from the central longitudinal axis of said first catheter when the first and second ends thereof are compressed, the second end of each of said plurality of cutting members being coupled to the distal end of said retractor member, said retractor member and said adjustment means selectively causing each of said plurality of cutting members to bow outwardly by an adjustable amount, and each of said plurality of elongated cutting members being rotated by said motor to remove atheromatous material or a blood clot from a blood vessel.

8. An expandable atherectomy catheter device as recited by claim 7 wherein said plurality of elongated cutting members are each formed of a length of wire.

9. An expandable atherectomy catheter device as recited by claim 7 wherein said plurality of elongated cutting members are each formed of a strip of metal.

10. An expandable atherectomy catheter device as recited by claim 7 wherein said plurality of elongated cutting members are formed by a tubular metal sleeve having a plurality of longitudinal slits formed therein generally parallel to each other for dividing said tubular metal sleeve into a plurality of elongated metal strips.

11. An expandable atherectomy catheter device as recited by claim 10 wherein said tubular metal sleeve has a longitudinal axis coaxial with the central longitudinal axis of said first catheter and wherein said plurality of slits each extend at an angle to a radial line passing through the longitudinal axis of said tubular metal sleeve for causing the edges of said plurality of elongated cutting members to form a knife edge for biting into an atheroma or blood clot when said elongated cutting members bow outwardly.

12. An expandable atherectomy catheter device as recited by claim 7 wherein said plurality of elongated cutting members each include a roughened outer surface for scraping atheromatous material or a blood clot when said elongated cutting members bow outwardly.

13. An expandable atherectomy catheter device as recited by claim 7 wherein said elongated retractor member comprises a second catheter disposed within said first catheter.

14. An expandable atherectomy catheter device as recited by claim 13 wherein said second catheter includes a continuous central lumen for receiving a guidewire.

15. An expandable atherectomy catheter device as recited by claim 7 wherein said elongated retractor member comprises a tension wire.

16. An expandable atherectomy catheter device as recited by claim 13 wherein said first catheter has a predetermined outer diameter, said atherectomy device further including a delivery catheter having an open distal end to be inserted into a blood vessel and having an opposing proximal end, said delivery catheter having a central lumen of a second predetermined inner diameter larger than the outer diameter of said first catheter for allowing said first catheter to be received within said delivery catheter, the distal end of said first catheter being adapted to be inserted into the central lumen of said delivery catheter through the proximal end of said delivery catheter and advanced therethrough to the pen distal end of said delivery catheter.

17. An expandable atherectomy catheter device as recited by claim 16 further including aspirating means coupled to the proximal end of one of said first catheter, second catheter, or delivery catheter, for aspirating atheromatous material or blood clot material cut by said plurality of elongated cutting members.

18. An expandable atherectomy catheter device as recited by claim 17 wherein said aspirating means is coupled to the proximal end of said second catheter, the distal end of said second catheter having an opening formed therein to aspirate portions of an atheroma or blood clot removed by said plurality of elongated cutting members.

19. An expandable atherectomy device as recited by claim 18 wherein said delivery catheter includes an infusion port coupled to the proximal end of said delivery catheter for infusing an irrigant to the distal end of said delivery catheter to assist in the removal of atheromatous material or blood clot material cut by said plurality of elongated cutting members.

20. An expandable atherectomy device as recited by claim 16 including an elastic skirt secured top said plurality of elongated cutting members and extending from the first ends of said plurality of elongated cutting members to approximately the central portions of said plurality of cutting members, said elastic skirt expanding to form a funnel shape when said plurality of cutting members are expanded, said atherectomy device further including aspirating means coupled to the proximal end of one of said first and second catheters for aspirating atheromatous material or blood clot material cut by said plurality of elongated cutting members, said elastic skirt collecting dislodged atheromatous material or blood clot material for aspiration.

21. An expandable atherectomy catheter device as recited by claim 7 including first drive means for coupling said motor to the proximal end of said first catheter for rotating said first catheter, and including second drive means for coupling said motor to the proximal end of said retractor member for rotating said retractor member, and wherein said adjustment means includes a control for manipulation by a user to adjust the outward bowing of said plurality of elongated cutting members while said motor is operating.

22. A method for removing atheroma or blood clots from a blood vessel, said method comprising in combination the steps of:

a. inserting a delivery catheter into a blood vessel until the distal end thereof is proximate the site of the atheroma or blood clot;

b. inserting into the delivery catheter a cutting head catheter having an expandable cutting head at the distal end thereof, and advancing the distal end of the cutting head catheter through the delivery catheter and out the distal end thereof to the site of the atheroma or blood clot, with the expandable cutting head in a collapsed condition;

c. expanding the cutting head of the cutting head catheter to increase the diameter thereof until approximating the diameter of the blood vessel at the site of the atheroma or blood clot; and

d. rotating the proximal end of the cutting head catheter to rotate the cutting head and remove the atheroma or blood clot.

23. The method recited by claim 22 including the further step of aspirating the blood vessel proximate the site of the cutting head to aspirate portions of the atheroma or blood clot removed by the cutting head.

24. The method recited by claim 23 including the further step of infusing an irrigant into the blood vessel proximate the site of the cutting head to help carry away dislodged portions of the atheroma or blood clot by said aspirating step.

25. The method recited by claim 24 wherein the irrigant is infused at approximately the same rate that the blood vessel is aspirated to minimize loss of blood from the blood vessel.