Flexible expandable electrode and method of intraluminal delivery of pulsed power

• US 10,314,649 B2
• Filed: 08/02/2012
• Issued: 06/11/2019
• Est. Priority Date: 08/02/2012
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Bakos, Gregory J., Plescia, David N., Long, Gary L., Shires, Peter K.
• Primary Examiner(s): Koharski, Christopher
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US13/565,307
• Publication Number:
  US 20140039491A1
• Time in Patent Office: 2,504 Days
• 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 for prostheses A61F2210/0014
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00202 rotating
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing

Abstract

A surgical instrument, such as an electrical ablation device, includes an elongate member having therealong disposed a first electrode extending along an axis. A first expandable portion extends along the axis and defines a first perimeter of the first electrode and has an associated first diameter with respect to the axis. The first expandable portion includes a first framework selectively expandable to transition the first expandable portion from a contracted state to an expanded state. The first framework is selectively contractible to transition the first expandable portion from the expanded state to the contracted state. When the first framework is expanded, the first diameter is expanded and the first expandable portion is transitioned from the contracted state to the expanded state. When the first framework is contracted, the first diameter is contracted and the first expandable portion is transitioned from the expanded state to the contracted state.

Claims

1. An electrical ablation device, comprising:

an elongate member;

a first electrode disposed along the elongate member and extending along an axis, the first electrode having a proximal end configured to couple to an energy source and a surface configured to couple to a tissue treatment region and apply ablative energy; and

a first expandable portion having a proximal end and a distal end and extending along the axis, the first expandable portion defining a first perimeter of the first electrode and having an associated first diameter with respect to the axis, wherein the first expandable portion comprises a first framework comprising a framework member, wherein the framework member comprises a helix extending along the first expandable portion, wherein a distal end of the framework member is configured to deliver electric current,

wherein the first framework is selectively expandable to transition the first expandable portion from a contracted state to an expanded state, and the first framework is selectively contractible to transition the first expandable portion from the expanded state to the contracted state,

wherein, when the first framework is expanded, the first diameter is expanded and the first expandable portion is transitioned from the contracted state to the expanded state,

wherein, when the first framework is contracted, the first diameter is contracted and the first expandable portion is transitioned from the expanded state to the contracted state,

wherein a relative rotation between a proximal portion and a distal portion of the framework member transitions the first expandable portion between the contracted state and the expanded state, and

wherein the relative rotation between the proximal portion and the distal portion of the framework member comprises a counter rotation of the distal portion of the framework member relative to the proximal portion of the framework member.

2. The electrical ablation device of claim 1, wherein the first electrode comprises a first flexible portion, and wherein at least a portion of the first expandable portion comprises at least a portion of the first flexible portion.

3. The electrical ablation device of claim 1, wherein the first framework is expandable to expand the first diameter to circumferentially contact a biological lumen at two or more locations about the circumference of a biological lumen.

4. The electrical ablation device of claim 1, wherein the framework member has an associated memory form and an associated retained form, and wherein the framework member is transitionable between the memory form and the retained form to expand and contract the first framework.

5. The electrical ablation device of claim 4, further comprising a retaining structure configured to retain the framework member in the retained form.

6. The electrical ablation device of claim 5, wherein the retaining structure comprises a sheath defining a channel configured to receive the framework member within a distal portion thereof, wherein the framework member is deployable from a distal end of the distal portion of the sheath, wherein the framework member is transitioned from the retained form to the memory form when deployed from the distal end of the sheath.

7. The electrical ablation device of claim 1, wherein the framework member is transitionable between an associated low temperature form and an associated high temperature form.

8. The electrical ablation device of claim 1, wherein the first framework further comprises a proximal and a distal coupler configured to couple the framework member within the first framework, wherein the proximal and distal couplers are separated by a distance, and wherein a transition from the contracted state to the expanded state further comprises a decrease in the distance between the proximal coupler and the distal coupler.

9. The electrical ablation device of claim 8, wherein the decrease in the distance between the proximal and distal coupler pivots at least a portion of the framework member outward of the axis.

10. The electrical ablation device of claim 1, further comprising:

a second electrode disposed along the elongate member and extending along the axis, the second electrode having a proximal end configured to couple to the energy source and a surface configured to couple to the tissue treatment region;

a second expandable portion having a proximal end and a distal end and extending along the axis, the second expandable portion defining a second perimeter of the second electrode having an associated second diameter with respect to the axis, wherein the second expandable portion comprises a second framework comprising one or more second framework members; and

the second framework selectively expandable to transition the second expandable portion from a contracted state to an expanded state, and the second framework selectively contractible to transition the second expandable portion from the expanded state to the contracted state, wherein, when the second framework is expanded, the second diameter is expanded and the second expandable portion is transitioned from the contracted state to the expanded state, and wherein, when the second framework is contracted, the second diameter is contracted and the second expandable portion is transitioned from the expanded state to the contracted state.

11. The electrical ablation device of claim 10, wherein the first electrode and the second electrode are separated by a distance along the elongate member, and wherein the distance between the first electrode and the second electrode is selectively adjustable.

12. A method of electrosurgically treating tissue, comprising:

obtaining the electrical ablation device of claim 1;

delivering the first electrode to a tissue treatment region comprising a biological lumen;

expanding the first electrode;

contacting the first electrode to a wall of the biological lumen proximal to the tissue to be treated; and

treating the tissue by applying, with the first electrode, one or more sequences of electric pulses to the tissue to be treated sufficient to induce cell death in the tissue by irreversible electroporation.

13. The method of electrosurgically treating tissue of claim 12, further comprising rotating the helix in a first direction within the biological lumen to continuously treat the entire biological lumen.

14. An electrical ablation device, comprising:

an elongate member;

a first electrode disposed along the elongate member and extending along an axis, the first electrode having a proximal end configured to wirelessly couple to an energy source and a surface configured to couple to a tissue treatment region and apply ablative energy; and

a first expandable portion having a proximal end and a distal end and extending along the axis, the first expandable portion defining a first perimeter of the first electrode and having an associated first diameter with respect to the axis, wherein the first expandable portion comprises a first framework comprising a framework member, wherein the framework member comprises a helix extending along the first expandable portion,

wherein a distal end of the framework member is configured to deliver electric current,

wherein the first framework is selectively expandable to transition the first expandable portion from a contracted state to an expanded state, and the first framework is selectively contractible to transition the first expandable portion from the expanded state to the contracted state,

wherein a relative rotation between a proximal portion and a distal portion of the framework member transitions the first expandable portion between the contracted state and the expanded state, and

wherein the relative rotation between the proximal portion and the distal portion of the framework member comprises a counter rotation of the distal portion of the framework member relative to the proximal portion of the framework member.

15. An electrical ablation device, comprising:

an elongate member;

an electrode disposed along the elongate member and extending along an axis, the electrode having a proximal end configured to couple to an energy source and a surface configured to couple to a tissue treatment region and apply ablative energy; and

an expandable portion comprising a proximal end and a distal end and extending along the axis, the expandable portion defining a perimeter of the electrode and having an associated diameter with respect to the axis, wherein the expandable portion comprises a framework comprising a framework member, wherein the framework member comprises a helix extending along the expandable portion,

wherein the framework is selectively expandable to transition the expandable portion from a contracted state to an expanded state, and the framework is selectively contractible to transition the expandable portion from the expanded state to the contracted state,

wherein a relative rotation between a proximal portion and a distal portion of the framework member transitions the expandable portion between the contracted state and the expanded state, and

wherein the relative rotation between the proximal portion and the distal portion of the framework member comprises a counter rotation of the distal portion of the framework member relative to the proximal portion of the framework member.