Guide wire passage creation device

• US 5,628,761 A
• Filed: 06/28/1995
• Issued: 05/13/1997
• Est. Priority Date: 07/08/1994
• Status: Expired due to Term

• Current Assignee: David G. Rizik
• Original Assignee: David G. Rizik
• Inventors: Rizik, David G.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): RASCHE, PATRICK WILLIAM
• Application Number:
  US08/495,366
• Time in Patent Office: 685 Days
• Field of Search: 606/159, 606/170, 606/171, 604/101, 604/96
• US Class Current: 606/170
• 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 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/320004 abrasive

Abstract

A device to be used in connection with revascularization, especially of the coronary arteries, makes it possible for conventional techniques such as angioplasty or atherectomy to be employed in totally or severely occluded blood vessels deemed otherwise impassable by a guide wire. A guide wire passage is created by providing a catheter with a retractable cutting head or laser source that penetrates the atheromatic material in a blood vessel. The device is centered and stabilized in the vessel by a circumferential balloon so that the passage through the atheromatic material is in the desired direction. The circumferential balloon also prevents blood flow in the event of a break in the blood vessel wall.

Claims

1. A guide wire passage creation device for use in a blood vessel impassably occluded by atheromatic material, the device being adapted to enable a subsequent revascularization process requiring traversal of the occlusion by a guide wire, the device comprising:

a catheter having proximal and distal ends, the distal end culminating in a tip;

means for creating a passage through the atheromatic material for subsequent guide wire traversal, the guide wire passage creation means being adapted to create a passage whose diameter is no larger than necessary to permit subsequent traversal by a guide wire;

the catheter having at least three lumens, comprising;

a first lumen having a diameter no greater than about 0.02 inches, for insertion of a guide wire and for injection of a contrast dye,

a second lumen including the guide wire passage creation means, and

a third lumen communicating with an annular balloon

disposed circumferentially at the distal end of the catheter adjacent the tip, the annular balloon having proximal and distal ends, and further comprising a plurality of smaller balloons disposed around the distal end of the annular balloon and spaced at approximately equal angular positions around the circumference of the annular balloon, the smaller balloons being selectively inflatable and deflatable to make intimate contact with the wall of the blood vessel to refine the position of the guide wire passage creation means in the vessel the annular balloon performing the following functions;

centering the distal end of the device when the distal tip of the device is positioned immediately proximal to the atheromatic material in the occluded blood vessel,

stabilizing the distal end of the device when the distal tip of the device is positioned immediately proximal to the atheromatic material in the occluded blood vessel, and

preventing blood flow in the event of a rupture in the blood vessel wall; and

operator controlled means at the proximal end of the device for deploying the multipurpose means and for deploying the guide wire passage creation means;

wherein the distal end of the catheter is substantially rigid from the tip to a distance beginning no less than about 10 millimeters and no more than about 20 millimeters from the tip, and wherein the multipurpose means is coaxial with the rigid portion of the catheter, so that the rigid portion and multipurpose means cooperatively act to center and stabilize the guide wire passage creation means in the blood vessel.

2. The device of claim 1, wherein the guide wire passage creation means is movable axially with respect to the catheter from a first position, at which the guide wire passage creation means is substantially within the multipurpose circumferential means, to a second position, up to about 20 millimeters in a distal direction beyond the distal tip of the catheter.

3. The device of claim 2 further comprising a hollow nose cone at the distal tip of the catheter, the nose cone having a central opening coaxial with the guide wire passage creation means through which the guide wire passage creation means passes when it is moved axially.

4. The device of claim 1, wherein the guide wire passage creation means is a rotating burr.

5. The device of claim 1, wherein the guide wire passage creation means is connected to the proximal end of the catheter by a hollow shaft.

6. The device of claim 5, wherein the guide wire passage creation means is a hollow rotating burr.