Rapid exchange stented balloon catheter having ablation capabilities

• US 6,053,913 A
• Filed: 09/10/1998
• Issued: 04/25/2000
• Est. Priority Date: 09/10/1998
• Status: Expired due to Fees

• Current Assignee: Irvine Biomedical, Inc. (Abbott Laboratories)
• Original Assignee: Hosheng Tu, Lily Chen Tu
• Inventors: Tu, Hosheng, Tu, Lily Chen
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): RUDDY, DAVID M
• Application Number:
  US09/150,182
• Time in Patent Office: 593 Days
• Field of Search: 606/91, 606/46, 606/47, 606/27, 606/29, 606/31, 606/191, 606/194, 606/198, 607/96, 607/99, 607/113, 607/101, 604/96, 604/99, 604/104, 604/114, 604/529
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

An ablation apparatus for treating tissues or atherosclerosis on a patient having a prior angioplasty procedure, the ablation apparatus comprising a rapid exchange stented balloon catheter having a reversibly collapsible stent secureed around the balloon and RF energy applied through the deployed stent to the tissue underlying the stent for therapeutic ablation purposes.

Claims

1. A rapid exchange stented balloon catheter system comprising:

a catheter shaft defining an inflation lumen, the inflation lumen having a proximal and distal ends;

an inflatable balloon having proximal and distal ends;

a wire guide shaft having proximal and distal ends defining a wire guide lumen having an open proximal end and an open distal end, wherein the proximal end of the wire guide shaft is distal to the distal end of the inflatable balloon and wherein the proximal end of the wire guide shaft is formed at an angle to a transverse axis of the wire guide shaft;

a reversibly collapsible stent made of a nitinol material formed in a mesh type ziz-zag configuration securely and firmly wrapped around said inflatable balloon, wherein an electrical conductor is connected to the stent;

said inflatable balloon having a variable diameter inflation profile for firmly securing the reversibly collapsible stent in place;

a catheter tip having proximal and distal ends, wherein the distal end of the inflation lumen opens into and is in communication with an interior of the inflatable balloon, the distal end of the inflatable balloon is sealed by the proximal end of the catheter tip, and the wire guide shaft is coupled only to the catheter tip completely distally of the distal end of the inflatable balloon;

a stiffening wire made of nitinol shape memory material, having a proximal end and a tapered distal end for providing increased flexibility at the distal end, wherein the stiffening wire extends through the interior of the inflation lumen and terminates within the catheter tip, the stiffening wire including a small ball at the distal end for anchoring the stiffening wire within the catheter tip;

at least one radiopaque marker band coupled to the stiffening wire for marking a location of at least one end of the inflatable balloon;

an external closed-loop temperature controller and a temperature sensor disposed near a midpoint along the length of the reversibly collapsible stent, the temperature sensor being connected to an external closed-loop temperature controller by means of an insulated temperature sensor wire which extends in a proximal direction from the temperature sensor;

said temperature sensor being adapted to sense and relay temperature to the controller; and

a RF generator, wherein RF current is provided through the electrical conductor to the reversibly collapsible stent.

2. The stented balloon catheter system of claim 1, wherein the RF current is in the range of 50 kHz to 2,000 kHz.

3. The stented balloon catheter system of claim 1, wherein the reversibly collapsible stent is made of material selected from the group of stainless steel, gold, silver, platinum, iridium and Nitinol.

4. The stented balloon catheter system of claim 1, wherein the balloon is made of material selected from the group consisting of polyethylene, cross-linked polyethylene, polyethylene terephthalate, and nylon.

5. A method of inserting a stented balloon catheter system into a patient'"'"'s body for treating stenosis, the catheter comprising a catheter shaft defining an inflation lumen, the inflation lumen having proximal and distal ends;

an inflatable balloon having proximal and distal ends;

a wire guide shaft having proximal and distal ends defining a wire guide lumen, the wire guide shaft having an open proximal end and an open distal end, wherein the proximal end of the wire guide shaft is distal to the distal end of the inflatable balloon and wherein the proximal end of the wire guide shaft is formed at an angle to a transverse axis of the wire guide shaft;

a reversibly collapsible stent made of a nitinol material formed in a mesh type ziz-zag configuration securely and firmly wrapped around said inflatable balloon, wherein an electrical conductor is connected to the stent;

said inflatable balloon having a variable diameter inflation profile for firmly securing the reversibly collapsible stent in place;

a catheter tip having proximal and distal ends, wherein the distal end of the inflation lumen opens into and is in communication with an interior of the inflatable balloon, the distal end of the inflatable balloon is sealed by the proximal end of the catheter tip, and the wire guide shaft is coupled only to the catheter tip completely distally of the distal end of the inflatable balloon;

a stiffening wire made of nitinol shape memory material, having a proximal end and a tapered distal end for providing increased flexibility at the distal end, wherein the stiffening wire extends through the interior of the inflation lumen and terminates within the catheter tip, the stiffening wire including a small ball at the distal end for anchoring the stiffening wire within the catheter tip;

at least one radiopaque marker band coupled to the stiffening wire for marking a location of at least one end of the inflatable balloon;

an external closed-loop temperature controller and a temperature sensor disposed near a midpoint along the length of the reversibly collapsible stent, the temperature sensor being connected to an external closed-loop temperature controller by means of an insulated temperature sensor wire which extends in a proximal direction from the temperature sensor;

said temperature sensor being adapted to sense and relay temperature to the controller;

and a RF generator, wherein RF current is provided through the electrical conductor to the reversibly collapsible stent;

the method comprising;

inserting the stented balloon catheter at a non-deployed state into the patient'"'"'s body to the location of stenosis;

inflating the inflatable balloon;

providing RF current to the reversibly collapsible stent in order to treat a patient'"'"'s stenosis;

deflating the inflatable balloon; and

withdrawing the stented balloon catheter from the patient'"'"'s body.