Method and apparatus for aiding dilatation catheterization

• US 4,798,586 A
• Filed: 04/09/1987
• Issued: 01/17/1989
• Est. Priority Date: 04/09/1987
• Status: Expired due to Term

• Current Assignee: Dow Corning Enterprises Incorporated
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Stevens, Robert C.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Reilly, Colleen M.
• Application Number:
  US07/036,223
• Time in Patent Office: 649 Days
• Field of Search: 128/305, 128/344, 128/267, 128/772, 128/348, 604/51-53, 604/96-99, 604/22, 604/93
• US Class Current: 604/96.01
• 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 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An improved technique for positioning a balloon dilatation catheter. When the balloon catheter approaches an obstruction that is difficult to enter, a drive catheter having a rotatable head is inserted into a central passageway in the catheter. The drive catheter bores through the obstruction allowing the balloon to be inserted and pressurized to compress obstructions and widen a passageway for blood flow.

Claims

1. A procedure for opening a blocked or partially blocked vessel comprising the steps of:

positioning a balloon catheter having a central passageway extending therethrough into proximity to a region of deposits that cause reduced blood flow in the blood vessel;

inserting an elongated rotatable member through the central passageway of the balloon catheter to cause a distal end of the rotatable member to extend beyond the balloon catheter and approach said deposits;

rotating the rotatable member relative the balloon catheter while bringing the distal end of the rotatable member into contact with the deposits to open a lumen through said deposits;

pushing the balloon catheter through the lumen opened by the distal end of the rotatable member to position the balloon within the deposits;

inflating the balloon to widen the lumen; and

deflating the balloon and withdrawing said balloon catheter from the blood vessel.

2. A process for opening a partially or totally blocked blood vessel comprising the steps of:

inserting an elongated dilatation catheter having an inflatable balloon at a distal end into the patient blood vessel;

routing the dilatation catheter through the blood vessel to bring the balloon into proximity to deposits that reduce blood flow within the blood vessel;

inserting an elongated rotatable drive having a rotatable head at one end through the elongated dilatation catheter to position said rotatable head in proximity to said deposits;

rotating said rotatable head relative to the balloon catheter while pushing the head into contact with the deposits to form an entryway for the dilatation catheter through the deposits; and

inserting the balloon through the entryway opened by the rotatable drive and inflating the balloon to widen a flowpath for blood to flow through said vessel.

3. The process of claim 2 wherein as the drive rotates the head and the head is pushed through the deposits the elongated dilatation catheter is used to guide the rotating head and prevent unwanted side to side movement of said rotating head.

4. A catheter system for cannulizing a blood vessel to increase blood flow through said blood vessel comprising:

(a) a flexible dilatation catheter having

(i) a balloon at its distal end for expanding the blood vessel,

(ii) an intermediate sheath defining a center passageway in communication with the blood vessel interior, and,

(iii) a proximal fitting outside a patient body having a first input in communication with the center passageway and a second input in fluid communication with the balloon;

(b) a drive catheter for insertion into the intermediate sheath of the flexible dilatation catheter and having a distal end defining a rotatable head for opening a lumen through deposits in the blood vessel, an elongated drive wire attached to the rotatable head for rotating the head, a sleeve for rotatably supporting the drive wire, a seal carried by the sleeve for impeding fluid entering a distal end of the sleeve from flowing out a proximal end of the sleeve and a coupling attached to a proximal end of said drive wire to rotate the drive wire;

(c) an adapter to mate with the dilatation catheter fitting and route the drive catheter into the central passageway of the dilatation catheter, said adapter including a seal to prevent fluid in the central passageway from leaking out the adapter along an outer surface of the drive catheter;

(d) drive means for rotating the drive catheter coupling to effect a rotation of the rotating head; and

(e) means for inflating the balloon by directing a fluid into said balloon through said second input after the balloon is pushed into the lumen formed by the rotating head.

5. The catheter system of claim 4 wherein the adapter defines a side branch in fluid communication with the central passageway of the dilatation catheter with the adapter is connected to said fitting.

6. The catheter system of claim 4 wherein the seal comprises a plastic sleeve heat treated to conform to an outer surface of the drive wire and a proximal end of tee sleeve for allowing high speed rotation of the drive wire with minimal frictional interference between the seal and the drive wire.

7. A catheter system for cannulizing a blood vessel to increase blood flow through said blood vessel comprising:

(a) a flexible dilatation catheter having a balloon at its distal end for expanding the blood vessel, an intermediate sheath defining a first passageway in communication with the blood vessel interior and a second passageway in communication with the balloon, and a fitting positioned outside a patient body when the dilatation catheter is in use, said fitting having a first input in communication with the center passageway of the intermediate sheath and a second input in fluid communication with the second passageway;

(b) an elongated drive catheter for insertion into and through the first passageway of the flexible catheter and having a distal end defining a head for opening a lumen through blood vessel obstructions, an elongated intermediate drive wire for rotating the head as the head is brought into contact with the obstructions, an elongated bearing supporting the drive wire for rotation and a coupling attached to a proximal end of said drive wire to rotate the drive wire;

said drive wire and coiled wire bearing having a length sufficient to position the distal head of said drive catheter beyond a distal end of the dilatation catheter as the coupling rotates the drive wire;

(c) drive means for rotating the coupling and drive wire relative said bearing to effect a rotation of the head; and

(d) means for inflating the balloon after the balloon is pushed into the lumen formed by the rotating head.

8. The catheter system of claim 7 additionally comprising an adapter to mate with the fitting and route the drive catheter into the first passageway, said adapter including a seal to prevent fluid in the first passageway of the dilatation catheter from leaking out the adapter along an outer surface of the drive catheter.

9. The catheter system of claim 7 wherein the bearing comprises a coiled wire bearing that rotatably supports a substantial length of said drive wire.