Selectively expandable operative element support structure and methods of use

• US 10,278,774 B2
• Filed: 03/18/2011
• Issued: 05/07/2019
• Est. Priority Date: 03/18/2011
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Wallace, Michael P., Garabedian, Robert, Utley, David S., Gerberding, Brent C., de Csepel, John
• Primary Examiner(s): Fowler, Daniel W
• Application Number:
  US13/051,738
• Publication Number:
  US 20120239028A1
• Time in Patent Office: 2,972 Days
• Field of Search: 606 20- 52
• CPC Class Codes: A61B 18/06 caused by chemical reaction , e.g. moxaburners
• CPC Class Codes: A61B 18/082 Probes or electrodes 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

In one embodiment, a device is provided including an expandable support member having a first portion and a second portion is provided. The first portion is adapted to have a smaller expansion index than the second portion. A therapeutic or diagnostic instrument is supported, at least in part, by the expandable support member first portion. In another embodiment, the support member is adapted for non-uniform expansion of the first and second portions. There are also described methods of forming therapeutic devices. There are also described methods of providing therapy to tissue in a body by positioning a device in proximity to tissue in a body selected to receive therapy. Next, the expandable support member second portion is expanded until the instrument is at a therapeutic position relative to the tissue in a body selected to receive therapy. Thereafter, therapy or diagnosis is provided to the selected tissue using the device.

Claims

1. A medical device, comprising:

an expandable support member having a first portion and a second portion, wherein the first portion is arranged such that it occupies an arc orthogonal to a longitudinal axis of the expandable support member and extends less than a full length along the longitudinal axis of the expandable support member, the first portion of the expandable support member having an exterior surface with a first surface area;

an expansion-resistant reinforcing element having a first side with a second surface area and a second side opposite the first side, the second surface area being substantially the same as the first surface area, the entire first side fixedly coupled with the exterior surface of the first portion of the expandable support member, wherein expansion of the first portion is constrained by at least the expansion-resistant reinforcing element such that the first portion has a smaller expansion index than that of the second portion; and

an operative element fixedly coupled with the second side of the expansion-resistant reinforcing element, wherein the operative element is operative over a third surface area that is substantially the same as the first surface area.

2. The device of claim 1, wherein the first and second portions are curviplanar aspects of the expandable support member, the first portion being partially-circumferential around the expandable support member.

3. The device of claim 1, wherein the operative element comprises a therapeutic instrument.

4. The device of claim 3, wherein the therapeutic instrument comprises a member selected from the group consisting of a bipolar radiofrequency (RF) electrode array, RF monopolar electrodes, and a combination of the same.

5. The device of claim 3, wherein the therapeutic instrument is an ablation device adapted to delivery energy to tissue, the ablation device selected from the group consisting of an RF ablation device, a microwave ablation device, an ultrasonic ablation device, a resistive heating ablation device, a chemical ablation device, a cryogenic ablation device, an ablation device for delivering a heatable fluid, and an optical heatable fluid.

6. The device of claim 1, wherein the expansion index of the expandable support member first portion is about 1.

7. The device of claim 1, wherein the expansion index of the expandable support member first portion is less than about 1.1.

8. The device of claim 1, wherein the expansion index of the expandable support member second portion is greater than 1 and less than 10.

9. The device of claim 1, wherein the expansion index of the expandable support member second portion is between about 2 and about 10.

10. The device of claim 1, wherein the expansion index of the second portion of the expandable support member relates to expansion along the longitudinal axis of the expandable support member.

11. The device of claim 10, wherein the expansion index of the second portion of the expandable support member further relates to expansion along a second axis orthogonal to the longitudinal axis of the expandable support member.

12. The device of claim 1, wherein the surface area of the operative element is different than the surface area of the expandable support member second portion when the expandable support member is expanded.

13. The device of claim 1, wherein the expansion-resistant reinforcing element comprises a flexible, non-distensible polymeric support.

14. The device of claim 13, wherein the flexible, non-distensible polymeric support comprises polyimide.

15. The device of claim 1, wherein the expandable support member comprises a balloon.

16. The device of claim 1, wherein the expandable support member is substantially cylindrical.

17. The device of claim 1, further comprising an elongate member adapted to support the expandable support member at a distal portion of the elongate member.

18. The device of claim 17, wherein the elongate member has a central longitudinal axis, and wherein the expandable support member is substantially cylindrical and coupled with the elongate member such that the central longitudinal axis of the elongate member and the longitudinal axis of the expandable support member are coaxial.

19. The device of claim 17, wherein the expandable support member is circumferentially arranged around the distal portion of the elongate member.

20. The device of claim 17, wherein at least a portion of the elongate member extends through a complete length of the expandable support member.

21. The device of claim 20, wherein at least a portion of the elongate member extends distally beyond the expandable support member.

22. A medical device, comprising:

an expandable support member adapted for coupling to a distal portion of an elongate member, the expandable support member having a first curviplanar portion and a second curviplanar portion, wherein the first curviplanar portion is arranged such that it occupies an arc orthogonal to a longitudinal axis of the expandable support member and extends less than a full length along the longitudinal axis of the expandable support member, the first curviplanar portion of the expandable support member having an exterior surface with a first surface area;

an expansion-resistant reinforcing element having a first side with a second surface area and a second side opposite the first side, the second surface area being substantially the same as the first surface area, the entire first side fixedly coupled with the exterior surface of the first curviplanar portion of the expandable support member, wherein expansion of the first curviplanar portion is constrained by at least the expansion-resistant reinforcing element such that the first curviplanar portion and the second curviplanar portion of the expandable support member have different expansion indices; and

an operative element fixedly coupled with the second side of the expansion-resistant reinforcing element, wherein the operative element is operative over a third surface area that is substantially the same as the first surface area.

23. The device of claim 22, wherein the first curviplanar portion and the second curviplanar portion are adapted such that a majority of the expansion occurs in the second curviplanar portion.

24. The device of claim 22, wherein the device is substantially round in an expanded state and the operative element extends less than 360 degrees around the device.

25. A system for ablation of tissue at a target site in an esophagus, comprising:

an expandable member adapted for coupling to a distal portion of an elongate member and sized to be positionable and expandable in the esophagus; and

an radio frequency (RF) ablation element having a first side with a first surface area and the entire first side fixedly coupled with an exterior surface of a first partially-circumferential portion of the expandable member, wherein the first partially-circumferential portion is arranged orthogonal to a longitudinal axis of the expandable member and extends less than a full length along the longitudinal axis of the expandable member, and wherein the first surface area is substantially the same as a surface area of the exterior surface of the first partially-circumferential portion, the RF ablation element adapted to resist expansion of the first partially-circumferential portion, the RF ablation element comprising a plurality of RF electrode pairs, a width of each RF electrode and a spacing between adjacent RF electrodes selected to allow depth-controlled ablation at the target site.

26. A medical device for ablation of tissue at a target site in an esophagus, comprising:

an expandable member adapted for coupling to a distal portion of an elongate member and sized to be positionable and expandable in the esophagus;

an electrode support comprising a flexible, non-distensible backing and having a first side with a first surface area and a second side opposite the first side, the entire first side of the electrode support fixedly coupled with a partially-circumferential exterior surface of the expandable member such that expansion of the partially-circumferential exterior surface is resisted by at least the electrode support, wherein the partially-circumferential exterior surface has a second surface area and occupies an arc orthogonal to a longitudinal axis of the expandable member and extends less than a full length along the longitudinal axis of the expandable member, and wherein the first surface area is substantially the same as the second surface area; and

a plurality of radio frequency (RF) electrode pairs on the second side of the electrode support, a width of each RF electrode and a spacing between adjacent RF electrodes selected to allow depth-controlled ablation at the target site.

27. A method of providing therapy to tissue in a body, comprising:

positioning a device comprising;

an expandable support member having a first portion and a second portion, wherein the first portion is arranged such that it occupies an arc orthogonal to a longitudinal axis of the expandable support member and extends less than a full length along the longitudinal axis of the expandable support member, the first portion of the expandable support member having an exterior surface with a first surface area;

an expansion-resistant reinforcing element having a first side with a second surface area and a second side opposite the first side, the second surface area being substantially the same as the first surface area, the entire first side fixedly coupled with the exterior surface of the first portion of the expandable support member, wherein expansion of the first portion is constrained by at least the expansion-resistant reinforcing element; and

an operative element fixedly coupled with the second side of the expansion-resistant reinforcing element, wherein the operative element is operative over a third surface area that is substantially the same as the first surface area;

expanding the second portion of the expandable support member to place the operative element in an operating position adjacent to tissue at the target site; and

providing therapy to the target tissue site using the operative element.

28. The method of claim 27, further comprising expanding the first portion to place the operative element in the operating position, wherein the first portion is expanded less than the second portion.

29. The method of claim 27, wherein the first portion is expanded by less than 10% and the second portion is expanded by more than 200%.

30. The method of claim 27, wherein the operating position is where the operative element is in contact with the target tissue site.

31. The method of claim 27, wherein providing therapy to the target tissue site using the operative element comprises ablating at least a portion of the tissue at the target site.

32. The method of claim 27, wherein providing therapy to the target tissue site using the operative element comprises obtaining information related to the tissue selected to receive therapy.

33. A method for treating tissue in a luminal organ, the method comprising:

inserting an electrode deployment apparatus into the luminal organ, the electrode deployment apparatus comprising;

an expandable member;

an electrode support comprising a flexible, non-distensible backing and having a first side with a first surface area and a second side opposite the first side, the entire first side of the electrode support fixedly coupled with a partially-circumferential exterior surface of the expandable member such that expansion of the partially-circumferential exterior surface is resisted by at least the electrode support, wherein the partially-circumferential exterior surface has a second surface area and occupies an arc orthogonal to a longitudinal axis of the expandable member and extends less than a full length along the longitudinal axis of the expandable member, and wherein the first surface area is substantially the same as the second surface area; and

an array of electrodes arranged on the second side of the electrode support;

expanding the expandable member to engage the electrodes with a target site on a wall of the luminal organ while maintaining an electrode density of the engaged electrodes; and

delivering energy from the electrodes to the target site.