Atherectomy device with angioplasty balloon and method

• US 5,181,920 A
• Filed: 12/10/1990
• Issued: 01/26/1993
• Est. Priority Date: 06/08/1990
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Devices for Vascular Intervention, Inc.
• Inventors: Pfeiffer, James F., Farley, Brian E., Mueller, Richard L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US07/624,855
• Time in Patent Office: 778 Days
• Field of Search: 604/22, 604/96, 128/750, 128/751, 128/752, 128/753, 128/754, 128/755, 606/159, 606/170, 606/171, 606/180
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An atherectomy device for reducing stenosis material from a vascular vessel is provided. The atherectomy device includes an elongated flexible tubular member having at least one lumen extending therethrough and having proximal and distal extremities. A flexible drive means disposed within the tubular members is free to move both rotationally and axially therein. A cutting assembly is carried by the distal extremity of the flexible tubular member with a cutter being carried by the distal extremity of the flexible drive means for removing a portion of the stenosis from the vessel wall. An inflatable dilation balloon is carried by the tubular member proximally of the cutter for further reducing the stenosis after initial reduction by the cutter. A perfusion channel maintains blood flow past the dilation balloon. Methods of the present invention include cutting and dilating a stenosis, cutting then immediately dilating a stenosis, and dilating then immediately cutting a stenosis.

Claims

1. In an atherectomy catheter for removal of at least a portion of a stenosis within a vessel, one elongate flexible tubular member having a torque transmitting layer, at least one lumen extending therethrough, and proximal and distal extremities, the tubular member being adapted for insertion into the vessel, a cutter housing secured to the distal end of the tubular member, flexible drive means disposed within the tubular member for rotational movement within the tubular member, a proximal actuator means for rotating said flexible drive means within the tubular member, and a cutter carried by the distal extremity of the flexible drive means and disposed in the housing for removing at least a portion of the stenosis, an inflatable dilation balloon carried by the tubular member proximally of the cutter housing and having the interior of the balloon in communication with the lumen in the flexible tubular member, means for securing a distal end of the dilation balloon to the exterior surface of the cutter housing, a shrink fit jacket extending over the torque transmitting layer and securing a proximal end of the dilation balloon to the tubular member, means for inflating and deflating the dilation balloon to further reduce the stenosis, and flexible guiding means extending forward of the cutter to travel axially within the vessel.

2. An atherectomy catheter as recited in claim 1 wherein said dilation balloon is mounted coaxially on the tubular member.

3. An atherectomy catheter as recited in claim 2 wherein said dilation balloon circumscribes the tubular member.

4. An atherectomy catheter as recited in claim 1 further comprising:

collection means for collecting the removed stenosis material.

5. An atherectomy catheter as recited in claim 1 wherein said cutter and flexible drive means are movable axially relative to the tubular member.

6. An atherectomy catheter as recited in claim 5 further comprising a generally cylindrical housing carried by the distal extremity of the tubular member, the housing being formed with a cutout extending longitudinally of the housing on one side of the housing, said cutter being disposed within the housing.

7. An atherectomy catheter as recited in claim 5 further comprising a generally cylindrical housing carried by the distal extremity of the tubular member for receiving the cutter, wherein said cutter has a forwardly extending annular cutting edge, said cutter being movable to an axial position wherein the cutting edge is spaced forwardly from the distal extremity of the housing.

8. An atherectomy catheter as recited in claim 5 wherein said cutter has a plurality of inclined cutting edges arranged to converge towards their distal extremities.

9. An atherectomy catheter as recited in claim 1 wherein the means for securing comprises an exterior recess formed in the housing and a wire carried by the distal extremity of the inflatable balloon for coupling the distal extremity of the balloon to the exterior recess of the housing.

10. A method of reducing stenosis within a vascular vessel to enlarge a fluid flow path within the vessel using an atherectomy catheter comprising one elongate flexible tubular member having a cutter within a housing and a dilation balloon carried proximally of the cutter housing, the method comprising the steps of:

inserting the catheter into the vessel and advancing the cutter housing to the region of the stenosis using a guidewire which defines a path for the housing;

cutting a portion of the stenosis from the vessel wall using the cutter in the housing;

advancing the dilation balloon into the region of the vessel where the stenosis material was removed; and

expanding the balloon to further expand the flow path where at least some cutting has occurred.

11. A method as recited in claim 10 further comprising the step of collecting the removed stenosis material in a collection chamber formed in a housing formed about the cutter.

12. An atherectomy device for expanding the fluid flow path through a stenosis within a vessel having walls and removing at least a portion of the stenosis, the device including:

one elongated flexible tubular member having at least one lumen extending therethrough a torque transmitting layer, and shrink fit jacket, the tubular member having proximal and distal extremities and a longitudinal axis;

flexible drive means disposed within the lumen of the tubular member and adapted for axial and rotational movement therein;

a proximal actuator assembly for rotating and translating said flexible drive means relative to the longitudinal axis of the tubular member;

a cutter carried on a distal end of the flexible drive means for removing a portion of the stenosis;

a cutter housing carried by the distal extremity of the tubular member for receiving the cutter;

flexible guiding means fixedly attached to the distal end of the cutter housing;

an inflatable dilation member carried by the tubular member proximally of the housing to expand the fluid flow path; and

means for inflating and deflating the inflatable dilation member,

wherein the shrink fit jacket is sized to extend over the proximal end of the inflatable dilation member for securing the inflatable dilation member in place.

13. An atherectomy device comprising:

a tubular member having a lumen extending between proximal and distal ends thereof;

a drive member disposed within the lumen of said tubular member;

a dilation balloon disposed at the distal end of said tubular member, said dilation balloon having a first inflation means;

a housing extending from the distal end of said tubular member, said housing having an interior open to the lumen of the drive member, an aperture on one side thereof, and having an atherectomy balloon on an opposite side thereof, said atherectomy balloon having a second inflation means;

a cutter disposed within said housing and coupled to said drive member; and

means for maintaining blood flow past said dilation balloon, said means comprising at least one perfusion hole positioned on the tubular means proximal to the dilation balloon for permitting blood flow into the lumen of the tubular member, whereby said blood flow can pass out through the aperture of the housing.

14. A method for treating atherosclerosis in a blood vessel, said method comprising:

positioning a device within the blood vessel proximate stenotic material, said device having a cutting means disposed at a distal end thereof and having a dilation balloon disposed proximal to said cutting means, said device further including means for maintaining blood flow past said dilation balloon;

severing the stenotic material with said cutting means, whereby the vessel is subject to abrupt reclosure; and

dilating the stenotic material with said dilation balloon, substantially immediately after the severing step, wherein blood flow is maintained past the dilation balloon by the means for maintaining blood flow.

15. The method of claim 14, wherein said dilating step comprises inflating the dilation balloon so that the stenotic material is predominantly severed at the beginning of the method and predominantly dilated at the end of the method.

16. The method of claim 14, wherein said dilating step comprises:

inflating the dilation balloon; and

thereafter

deflating the dilation balloon so that the stenotic material is predominantly dilated at the beginning of the method and predominantly severed at the end of the method.

17. A method for treating atherosclerosis in a blood vessel, said method comprising:

positioning a device within the blood vessel proximate a stenosis, said device having a housing with an elongate side aperture secured to a distal end thereof, a cutting means disposed within the housing, and a dilation balloon disposed proximal to said housing, said device further including means for maintaining blood flow past said dilation balloon, and into the housing;

severing the stenosis with said cutting means;

thereafter

immediately advancing said device for positioning said dilation balloon proximate said stenosis; and

inflating said dilation balloon to dilate the stenosis while the cutting means is positioned relative to the housing to permit blood flow out through the side aperture of the housing.

18. A method for reducing stenosis in a blood vessel and treating abrupt closure of the blood vessel, said method comprising:

positioning a device within the blood vessel proximate a stenosis, said device having a housing with an elongate side aperture secured to a distal end thereof, a cutting means disposed within the housing, and a dilation balloon disposed proximal to said housing, said device further including means for maintaining blood flow past said dilation balloon and into the housing;

severing the stenosis with said cutting means;

if the blood vessel abruptly closes, immediately advancing said device for positioning said dilation balloon proximate said stenosis; and

inflating said dilation balloon to dilate the stenosis while the cutting means is positioned relative to the housing to permit blood flow out through the side aperture of the housing.

19. A method for treating atherosclerosis in a blood vessel, said method comprising:

positioning a device within the blood vessel proximate a stenosis, said device having a housing with an elongate side aperture secured to a distal end thereof, a cutting means disposed within the housing, and a dilation balloon disposed proximal to said housing, said device further including means for maintaining blood flow past said dilation balloon and into the housing;

dilating the stenosis with said dilation balloon;

thereafter

immediately retracting said device for positioning said cutting means proximate said stenosis; and

severing the stenosis with said cutting means.