Expandable electrode assemblies for forming lesions to treat dysfunction in sphincters and adjoining tissue regions

• US 6,258,087 B1
• Filed: 05/04/1999
• Issued: 07/10/2001
• Est. Priority Date: 02/19/1998
• Status: Expired due to Term

• Current Assignee: Mederi Rf, LLC
• Original Assignee: Curon Medical, Inc.
• Inventors: West, Scott, Utley, David, Gaiser, John, Edwards, Stuart, Chin, Jay
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/304,773
• Time in Patent Office: 798 Days
• Field of Search: 606/41, 606/42, 606/45-50, 600/374, 607/101, 607/102, 607/115, 607/116, 607/122, 607/133
• US Class Current: 606/41
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/0066 without feedback, i.e. open loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration

Abstract

Expandable assemblies for treating a tissue region at or near a sphincter comprises a support basket formed from an array of spines. A mechanism flexes the spines to expand and collapse the basket. Electrodes carried by the spines for advancement in a path to penetrate the tissue region upon expansion of the basket. The basket can be formed from a mechanical array of molded, jointed spines, or from an extruded tube having axial slits forming the spines.

Claims

1. An assembly for treating a tissue region at or near a sphincter comprising

a support structure comprising an array of jointed spines having proximal and distal ends joined to form a basket, at least one of the jointed spines including a molded hinge about which flexure occurs,

a mechanism to flex the jointed spines to expand and collapse the basket, and

electrodes carried by the jointed spines for advancement in a path to penetrate the tissue region upon expansion of the basket.

3. An assembly according to claim 1 or 2

wherein at least one of the electrodes comprises an integrally molded part of the respective spine.

4. An assembly according to claim 1 or 2

wherein at least one of the electrodes is secured to the respective spine.

5. An assembly according to claim 1 or 2

wherein the mechanism comprises a pull wire attached to the distal ends of the spines to draw the distal ends toward the proximal ends, thereby flexing the jointed spines outward to expand the basket.

6. An assembly according to claim 1 or 2

wherein the mechanism comprises a push wire attached to the proximal ends of the spines to advance the proximal ends toward the distal ends, thereby flexing the jointed spines outward to expand the basket.

7. An assembly according to claim 1 or 2

wherein, when the basket is collapsed, the electrodes nest within the jointed spines.

8. An assembly according to claim 1 or 2

wherein, as the basket expands, the electrodes swing relative to the jointed spines in the path to penetrate tissue.

9. An assembly according to claim 1 or 2

wherein at least four electrodes are carried in a circumferentially spaced apart relationship by the spines.

10. An assembly according to claim 1 or 2

wherein eight electrodes are carried in a circumferentially spaced apart relationship by the spines.

11. An assembly according to claim 1 or 2

further including a connector to couple the electrodes to a source of radio frequency energy to ohmically heat tissue and create lesions in the tissue region.

2. An assembly for treating a tissue region at or near a sphincter comprising

a support structure comprising an array of jointed spines having proximal and distal ends joined to form a basket, at least one of the jointed spines including a mechanical hinge about which flexure occurs,

a mechanism to flex the jointed spines to expand and collapse the basket, and

electrodes carried by the jointed spines for advancement in a path to penetrate the tissue region upon expansion of the basket.

12. An assembly for treating a tissue region at or near a sphincter comprising

a support structure comprising an extruded tube having axial slits forming an array of spines forming a basket,

a mechanism to flex the spines to expand and collapse the basket, and

electrodes carried by the spines for advancement in a path to penetrate the tissue region upon expansion of the basket.

13. An assembly according to claim 12

wherein at least one of the electrodes is carried in a co-extruded lumen in a wall of the tube.

14. An assembly according to claim 12

wherein the extruded tube includes a proximal end and a distal end free of slits.

15. An assembly according to claim 14

wherein the mechanism comprises a pull wire attached to the distal end of the extruded tube to draw the distal end toward the proximal end, thereby flexing the spines outward to expand the basket.

16. An assembly according to claim 14

wherein the mechanism comprises a push wire attached to the proximal end of the extruded tube to advance the proximal end toward the distal end, thereby flexing the spines outward to expand the basket.

17. An assembly according to claim 12

wherein at least four electrodes are carried in a circumferentially spaced apart relationship by the spines.

18. An assembly according to claim 12

wherein eight electrodes are carried in a circumferentially spaced apart relationship by the spines.

19. An assembly according to claim 12

further including a connector to couple the electrodes to a source of radio frequency energy to ohmically heat tissue and create lesions in the tissue region.

20. An assembly according to claim 12

further including a co-extruded lumen in a wall of the extruded tube attachable to a fluid source and having an outlet to dispense fluid into heat conductive contact with tissue in the tissue region.

21. An assembly according to claim 12

further including a co-extruded lumen in a wall of the extruded tube attachable to an aspiration source and having an inlet to remove fluid from the tissue region.