Electro-coagulation and ablation and other electrotherapeutic treatments of body tissue

• US 5,403,311 A
• Filed: 03/29/1993
• Issued: 04/04/1995
• Est. Priority Date: 03/29/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Rowe, Steven, Rowland, Christopher A., Vergano, Michael G., Abele, John E.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/038,903
• Time in Patent Office: 736 Days
• Field of Search: 604/20-22, 606/37-41, 606/45-50, 607/104, 607/105, 607/120, 607/122, 607/125, 607/126
• US Class Current: 606/49
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00595 Cauterization
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means

Abstract

A catheter includes a flexible elongated catheter body that defines a needle-receiving, or probe-receiving, lumen, a retractable tissue-penetrable needle, or probe, and an electrode mounted on the distal portion of the catheter body. The needle provides a fluid passage for introducing fluid into tissue to permit the introduction of sclerotic agents for enhancing electrocoagulation of the tissue, heat-responsive drugs for improving the bonding to tissue surfaces, or vaso-constrictor drugs. The probe can also have a passage for fluid. The electrode can provide bipolar electro-coagulation of tissue in combination with an additional electrode mounted on the catheter body, or alternatively, the electrode can be employed in combination with either the needle or probe to establish a bipolar electro-coagulation path through tissue. The needle, or probe, in combination with an external electrode can be used to provide unipolar electro-coagulation, or ablation. In certain instances, the electrode can be used to provide a mapping function inside cardiac chambers.

Claims

1. An electro-coagulation constructed for passage into a living body to perform therapy on a selected region of body tissue, said catheter comprising

a flexible, pushable, elongated catheter body of braided construction having proximal and distal portions terminating respectively at proximal and distal ends defining a tube-receiving lumen having a length that extends from the proximal end of said catheter body to the distal end of said catheter body, said length being selected to perform therapy on selected regions of body tissue within the gastrointestinal tract or the esophagus of a patient while the proximal end of said catheter body remains outside the patient,

an RF electrocoagulation electrode coupled to the distal portion of said catheter body, said electrode being connected to a respective conductor extending within said catheter body,

a retractable, flexible hollow tube having a tissue-penetrable needle-form distal end and having a proximal end and extending within said tube-receiving lumen and along the entire length thereof, said flexible hollow tube having a fluid passage therethrough for introducing a fluid into the tissue in the selected region, said flexible hollow tube being selectively slidable within said tube-receiving lumen of said catheter body to cause said needle-form distal end of said flexible tube to be projectable from and retractable into the distal end of said catheter body by actuation force applied to the proximal end of said flexible hollow tube, and

means for remotely applying actuation force to the proximal end of said flexible hollow tube to cause said needle-form distal end of said flexible hollow tube to project from the distal end of said catheter body for penetration of tissue within the gastrointestinal tract or esophagus of the patient.

2. The catheter of claim 1 further comprising a second electrode coupled to the distal portion of said catheter body, said electrode and said second electrode being constructed and arranged to establish a bipolar RF electro-coagulation path through the selected region of body tissue.

3. The catheter of claim 2 wherein said electrode and said second electrode are arranged in a spaced-apart helical arrangement at the distal end of said catheter body.

4. The catheter of claim 1 wherein said electrode is a ring electrode.

5. The catheter of claim 1 wherein said applying means comprises a push-pull wire coupled to said needle for applying actuation force to said needle.

6. The catheter of claim 1 wherein the distal portion of said needle comprises electrically conducting material.

7. The catheter of claim 6 wherein said needle is connected to a respective conductor that extends within said catheter body for connection to an RF generator, said needle and said electrode being configured to establish therebetween a bipolar RF electro-coagulation path through the selected region of body tissue.

8. The catheter of claim 1 wherein the distal portion of said catheter body is dome-shaped and made from a refractory material, and wherein said electrode comprises a conductive metallic layer bonded to said refractory material.

9. The catheter of claim 1 further comprising a second retractable hollow needle, the distal portion of said second needle being selectively projectable from and retractable into the distal end of said catheter body by actuation force applied to the proximal portion of said second needle.

10. The catheter of claim 9 wherein said needle and said second needle have electrically conductive distal portions that are connected to respective conductors for connection to an RF generator, wherein said needle and said second needle, when projected into tissue, are capable of subsurface bipolar electrocoagulation therebetween.

11. The catheter of claim 1 further comprising

a selectively retractable sleeve disposed around at least a portion of said needle, and

means for selectively extending and retracting said sleeve independently of said needle so that, when said needle is extended, the exposed surface of the distal portion of said needle can be selectively varied by extension or retraction of said sleeve.

12. The catheter of claim 1 wherein said catheter body has at least one precurved portion capable of being elastically deformed to conform to an introducing channel through which it passes into the body, said catheter body being constructed to transmit torque from the proximal portion of said catheter body to the distal portion of said catheter body so that the orientation of said precurved portion can be adjusted by applying torque to the proximal portion of said catheter body.

13. The catheter of claim 1 further comprising proximal markings coupled to said force applying means that serve to identify the distance said needle is extended beyond the distal end of said catheter body, thereby enabling said needle to be controllably extended a desired length into tissue in the selected region.

14. The catheter of claim 1 further comprising a longitudinally extending irrigation passage through said catheter body for providing perfusion fluid to cleanse the selected region of body tissue.

15. A method of electro-coagulating a selected region of body tissue comprising the steps of

inserting into a living body a bipolar electro-coagulation catheter having proximal and distal portions respectively terminating at proximal and distal ends to the site of the selected region, said catheter comprising

a flexible, pushable, elongated catheter body of braided construction having proximal and distal portions terminating respectively at proximal and distal ends defining a tube-receiving lumen having a length that extends from the proximal end of said catheter body to the distal end of said catheter body, said length being selected to perform therapy on selected regions of body tissue within the gastrointestinal tract or the esophagus of a patient while the proximal end of said catheter body remains outside the patient,

first and second RF electrocoagulation electrodes coupled to the distal portion of said catheter body, said electrodes being connected to respective conductors extending within said catheter body, and

a retractable, flexible hollow tube having a tissue-penetrable needle-form distal end and having a proximal end and extending within said tube-receiving lumen and along the entire length thereof, said flexible hollow tube having a fluid passage therethrough for introducing a fluid into the tissue in the selected region, said flexible hollow tube being selectively slidable within said tube-receiving lumen of said catheter body to cause said needle-form distal end of said flexible tube to be projectable from and retractable into the distal end of said catheter body by actuation force applied to the proximal end of said flexible hollow tube,

inserting said needle-form distal end of said flexible hollow tube into tissue in the selected region,

contacting said first and second electrodes with the surface of tissue in the selected region,

introducing a fluid into tissue in the selected region through said flexible hollow tube and needle-form distal end, and

applying RF coagulation voltage between said first and second electrodes to effect bipolar electro-coagulation of the selected region of body tissue.

16. The method of claim 15 wherein said fluid comprises a heat-responsive drug.

17. The method of claim 15 wherein said fluid comprises a sclerotic agent.

18. The method of claim 15 wherein said fluid is a vaso-constrictive agent.

19. The method of claim 15 wherein the distal portion of said needle is electrically conductive and is electrically coupled to a respective conductor for connection to an RF generator, and wherein the step of applying comprises applying RF bipolar electro-coagulation voltage between the electrically conductive portion of said needle and at least one of said first and second electrodes.