Ablation device for treating atherosclerotic tissues

• US 6,036,689 A
• Filed: 09/24/1998
• Issued: 03/14/2000
• Est. Priority Date: 09/24/1998
• 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:
  US09/159,697
• Time in Patent Office: 537 Days
• Field of Search: 604/96-101, 606/191, 606/192, 606/194, 606/41, 606/34, 607/119, 607/122
• US Class Current: 606/41
• 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: C08L 2201/12 Shape memory

Abstract

An ablation device for treating atherosclerotic tissues of a patient, the ablation device comprising a catheter shaft and an inner catheter, the inner catheter having a deployable electrode means, wherein the deployable electrode means comprises a plurality of preshaped expandable metallic basket members at the distal end of the inner catheter adapted to contact the atherosclerotic tissues and to apply RF current to the tissues for therapeutic purposes. Alternately, a plurality of expandable metallic basket members are wrapped onto and around a balloon of an ablation device system.

Claims

1. An ablation device system comprising:

A catheter shaft having a distal section, a shaft distal end, a shaft proximal end, and at least one lumen extending between the shaft proximal end and the shaft distal end, wherein the at least one lumen has at least one opening at the shaft distal end of the catheter shaft;

a handle attached to the shaft proximal end of the catheter shaft, wherein the handle has a cavity;

an inner catheter located inside the at least one lumen of the catheter shaft, wherein the inner catheter comprises a distal end, a proximal end, and at least one lumen extending between the distal end and the proximal end;

an inflation tubing extending distally to the distal end of the inner catheter, the inflation tubing having a proximal end and a distal end;

an inflatable balloon having a proximal end and a distal end, wherein the distal end of the inflation tubing opens into and is in communication with an interior of the inflatable balloon, wherein the distal end of the inflatable balloon is sealed;

an electrode arrangement mounted at the distal end of the inner catheter, wherein the electrode arrangement comprises a plurality of expandable metallic basket members wrapped onto and around the inflatable balloon, each expandable metallic basket member having a basket distal end and a basket proximal end, wherein the basket proximal ends of the expandable metallic basket members are joined at the distal end of the inner catheter and wherein the basket distal ends of the expandable metallic basket members are joined at a distal joint;

an electrode deployment mechanism mounted on the handle, wherein the electrode deployment mechanism is attached to the proximal end of the inner catheter, wherein the plurality of expandable metallic basket members are expanded at a deployed state, and wherein the plurality of expandable metallic basket members are retracted at a non-deployed state;

a RF current generating means, wherein the RF current is supplied to the electrode arrangement for therapeutic purposes; and

a wire guide shaft at the distal section of the catheter shaft, the wire guide shaft defining a wire guide lumen, the wire guide shaft having a proximal end and a distal end, wherein the distal end of the wire guide shaft is proximal to the proximal end of the inflatable balloon, and the wire guide shaft is coupled only to the tip section of the catheter shaft completely proximally of the proximal end of the inflatable balloon.

2. The ablation device system as in claim 1 further comprising at least one temperature sensor, wherein the temperature sensor is disposed at close proximity of the electrode arrangement of the inner catheter.

3. The ablation device system as in claim 2 further comprising a temperature control means, wherein a temperature measured from the temperature sensor is relayed to the temperature control means and is adapted to effect the RF current supply to the ablation device system.

4. The ablation device system of claim 1, wherein the RF current is within the range of 50 to 2,000 kHz.

5. The ablation device system of claim 1, wherein a material for the expandable metallic basket members of the electrode arrangement is selected from the group consisting of platinum, iridium, gold, silver, stainless steel, Nitinol, and an alloy of their mixtures.

6. The ablation device system of claim 1, wherein a portion of the expandable metallic basket members is essentially straight.

7. A method for treating atherosclerotic tissues of a patient using an ablation device system, the ablation device system comprising

A catheter shaft having a distal section, a shaft distal end, a shaft proximal end, and at least one lumen extending between the shaft proximal end and the shaft distal end, wherein the at least one lumen has at least one opening at the shaft distal end of the catheter shaft;

a handle attached to the shaft proximal end of the catheter shaft, wherein the handle has a cavity;

an inner catheter located inside the at least one lumen of the catheter shaft, wherein the inner catheter comprises a distal end, a proximal end, and at least one lumen extending between the distal end and the proximal end;

an inflation tubing extending distally to the distal end of the inner catheter, the inflation tubing having a proximal end and a distal end;

an inflatable balloon having a proximal end and a distal end, wherein the distal end of the inflation tubing opens into and is in communication with an interior of the inflatable balloon, wherein the distal end of the inflatable balloon is sealed;

an electrode arrangement mounted at the distal end of the inner catheter, wherein the electrode arrangement comprises a plurality of preshaped expandable metallic basket members wrapped onto and around the inflatable balloon, each expandable metallic basket member having a basket distal end and a basket proximal end, wherein the basket proximal ends of the expandable metallic basket members are joined at the distal end of the inner catheter and wherein the basket distal ends of the expandable metallic basket members are joined at a distal joint;

an electrode deployment mechanism mounted on the handle, wherein the electrode deployment mechanism is attached to the proximal end of the inner catheter, wherein the plurality of preshaped expandable metallic basket members are expanded at a deployed state, and wherein the plurality of expandable metallic basket members are retracted at a non-deployed state;

a RF current generating means, wherein the RF current is supplied to the electrode arrangement for therapeutic purposes; and

a wire guide shaft at the distal section of the catheter shaft, the wire guide shaft defining a wire guide lumen, the wire guide shaft having a proximal end and a distal end, wherein the distal end of the wire guide shaft is proximal to the proximal end of the inflatable balloon, and the wire guide shaft is coupled only to the tip section of the catheter shaft completely proximally of the proximal end of the inflatable balloon;

The method comprising the steps of;

(a) inserting the ablation device through an artery or a vein to the location of the atherosclerotic tissues;

(b) deploying the electrode arrangement to expand the preshaped expandable metallic basket members adapted to contact the atherosclerotic tissues; and

(c) applying RF current to the electrode arrangement to effect treatment of the atherosclerotic tissues.

8. The method for treating atherosclerotic tissues of a patient using an ablation device system as in claim 7, the method further comprising the ablation device system comprising at least one temperature sensor, wherein the temperature sensor is disposed at close proximity of the electrode arrangement of the inner catheter.

9. The method for treating atherosclerotic tissues of a patient using an ablation device system as in claim 7, the method further comprising the ablation device system comprising a temperature control means, wherein a temperature measured from the temperature sensor is relayed to the temperature control means and adapted to effect the RF energy supply to the electrode means.

10. The method for treating atherosclerotic tissues of a patient using an ablation device system as in claim 7, the method further comprising the ablation device system having a RF current delivery within the range of 50 to 2,000 kHz.

11. The method for treating atherosclerotic tissues of a patient using an ablation device system as in claim 7, wherein a material for the electrode arrangement is selected from the group consisting of platinum, iridium, gold, silver, stainless steel, Nitinol, and an alloy of their mixtures.

12. The method for treating atherosclerotic tissues of a patient using an ablation device system as in claim 7, wherein a portion of the preshaped expandable metallic basket members is essentially straight.