SELECTIVELY EXPANDABLE OPERATIVE ELEMENT SUPPORT STRUCTURE AND METHODS OF USE

• US 20120239028A1
• Filed: 03/18/2011
• Published: 09/20/2012
• 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
• Granted Patent: US 10,278,774 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 adapted to have a smaller expansion index than that of the second portion; and

an operative element supported by the expandable support member first portion.

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.

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

4. The device according to 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 according to claim 3 wherein the 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 surface area of the expandable support member first portion is substantially the same as the surface area of the operative element.

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

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

9. The device of claim 1 wherein the expansion index of the expandable support member second portion is significantly greater than 1.

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

11. The device of claim 1 wherein the expansion index of the second portion of the expandable support member relates to expansion along a first axis.

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

13. 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.

14. The device of claim 1 wherein the wall thickness of the expandable support member first portion is greater than the wall thickness of the expandable support member second portion.

15. The device of claim 1 wherein the wall thickness of the expandable support member varies around a radial cross section that includes a profile supporting the operative element.

16. The device of claim 15 wherein the wall thickness of the first portion of the expandable support member varies around a radial cross section that includes a profile supporting the operative element.

17. The device of claim 15 wherein the wall thickness of the second portion of the expandable support member varies around a radial cross section that includes a profile supporting the operative element.

18. The device of claim 1 wherein the wall thickness of the expandable support member second portion varies along a longitudinal cross section that includes a profile supporting the operative element.

19. The device of claim 16 wherein the wall thickness of the first portion of the expandable support member second portion varies along a longitudinal cross section that includes a profile supporting the operative element.

20. The device of claim 18 wherein the wall thickness of the second portion of the expandable support member second portion varies along a longitudinal cross section that includes a profile supporting the operative element.

21. The device of claim 1, further comprising an expansion resistant reinforcing element arrangement on a surface of the expandable support structure first portion.

22. The device of claim 21 wherein the expansion-resistant reinforcing arrangement is coupled to an exterior surface of the expandable support element.

23. The device of claim 22 wherein the expansion-resistant reinforcing arrangement comprising a flexible, non-distensible polymeric support.

24. The device of claim 22 wherein the flexible, non-distensible polymeric support comprises polyimide.

25. The device of claim 21 wherein the expansion-resistant reinforcing arrangement is coupled to an interior surface of the expandable support element.

26. The device of claim 1 further comprising an expansion-resistant reinforcing element arrangement integrated into the structure of the expandable support structure first portion.

27. The device of claim 1, further comprising an expansion-resistant reinforcing element arrangement coupled to the first portion, the arrangement comprising structure integral to the operative element.

28. The device of claim 1 first portion comprises a first composition and the second portion comprises a second composition, the first and second portions joined so as to form an expandable member of joined integrity, the expansion index of the first composition being lower than that of the second composition.

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

30. The device of claim 1 wherein expandable support member is substantially cylindrical with a longitudinal axis, and wherein the first portion is arranged such that occupies an arc orthogonal to the longitudinal axis less than fully circumferential around the balloon.

31. 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.

32. The device of claim 31, wherein the elongate member has a central longitudinal axis, and wherein the expandable support member is substantially cylindrical with a longitudinal axis, the longitudinal axis of the elongate member and the expandable support member being parallel.

33. The device of claim 31, wherein the expandable support member is circumferentially arranged around the distal portion of the elongate member.

34. The device of claim 31, wherein at least a portion of the elongate member extends through a complete length of the expandable member.

35. The device of claim 34 wherein at least a portion of the elongate member extends distally beyond the expandable member.

36. A medical device, comprising:

an expandable support member adapted for coupling to a distal portion of an elongate member, the member having a first curviplanar portion and a second curviplanar portion, the support member adapted such that the first and second portions have different expansion indices; and

an operative element supported on the first portion of the expandable support member.

37. The device of claim 36 wherein the first portion of the support member has about the same surface area as that of the operative element.

38. The device of claim 36 wherein the first and second portions are adapted such that a majority of the expansion occurs in the second portion.

39. The device of claim 36 wherein the first portion of the expandable support member comprises an area of substantially limited expandability.

40. The device of claim 39 wherein the area of substantially limited expandability comprises a reinforcing element.

41. A medical device, comprising:

an expandable support member adapted for coupling to a distal portion of an elongate member, the member having a substantially non-expandable partially-circumferential curviplanar portion; and

an operative element supported on the substantially non-expandable portion of the expandable support member.

42. The device of claim 41 wherein the expandable support member further comprises an expandable curviplanar portion, the operative element being supported only on the substantially non-expandable portion of the expandable support member.

43. The device of claim 42, wherein the substantially non-expandable portion and the expandable portion are adjacent one another.

44. The device of claim 41 wherein the operative element extends less than the entire circumference of the device.

45. The device of claim 41 wherein the device is substantially round in an expanded state and the operative element extends less 360 degrees around the device.

46. The device of claim 41 wherein the operative element is mounted onto the expandable support member.

47. 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 RF ablation element non-distensibly arranged over a partially-circumferential portion of the expandable member, 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.

48. The system of claim 47 wherein the RF ablation element is arranged directly on the partially-circumferential portion of the expandable member, such portion being substantially non-distensible, the balloon further comprising a second portion that is distensible.

49. The system of claim 47, further comprising a non-distensible RF ablation element support layered over the partially-circumferential portion of the expandable member, the RF ablation element being arranged on the non-distensible RF ablation element support.

50. 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 extending partially around a circumference of the expandable member, and

a plurality of RF electrode pairs on 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.

51. 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, the expandable member comprising;

a first partially-circumferential curvilinear portion; and

a second partially-circumferential curvilinear portion, the first portion having a smaller index of expansion than the second portion, and the first portion comprising an electrode support; and

a plurality of RF electrodes on 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.

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

positioning a device comprising an operative element supported on a first portion of an expandable support member in proximity to a target tissue site in a body;

expanding another 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.

53. The method of claim 52 wherein the first portion and the another portion are integrally formed.

54. The method of claim 52 further comprising expanding the first portion to place the operative element in the operating position, wherein the first portion is expanded less than the another portion.

55. The method of claim 52 wherein the first portion is expanded by less than 10% and the second portion is expanded by more than 200%.

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

positioning an operative element in proximity to a target tissue site in a body, the operative element supported by an expandable support member comprising a first portion and a second portion, the first portion being adapted to have a smaller expansion index than that of the second portion, the operative element supported by the first portion;

expanding the expandable support member until the operative element is in an effective operating position relative to the target tissue site; and

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

57. The method of claim 56 wherein expanding the expandable support member comprises expanding the second portion of the expandable support member.

58. The method of claim 56 wherein expanding the expandable support member comprises constraining the first portion of the expandable support member from expanding when the second portion is expanding.

59. The method of claim 58 wherein constraining the first portion of the expandable support member from expanding comprises constraining expansion by having an increased thickness of a material within the first portion.

60. The method of claim 58 wherein constraining the first portion of the expandable support member from expanding comprises constraining an expandable material with an integrated or coupled reinforcing element arrangement within the first portion.

61. The method of claim 56 wherein the effective operating position is where the operative element is in contact with the target tissue site.

62. The method of claim 56 wherein the effective operating position is where the operative element is spaced apart from the target tissue site.

63. The method of claim 56 wherein providing therapy to target tissue site using the operative element comprises ablating at least a portion of the tissue at the target site.

64. The method of claim 56 wherein providing therapy to a target tissue site using the operative element comprises obtaining information related to the tissue selected to receive therapy.

65. A method of delivering energy at a substantially constant delivery density from an ablational structure arranged on an expandable support member comprising:

arranging the ablational structure on a first portion of an expandable support member comprising a first partially-circumferential portion and a second partially-circumferential portion, the first portion being substantially non-distensible;

positioning the ablational structure in proximity to a target tissue site;

expanding the expandable support member until the ablational structure is in a therapeutically effective operating position relative to the target tissue site; and

delivering energy to the target tissue site using the ablational structure.

66. 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 array of electrodes arranged on a non-distensible and partially-circumferential portion of an exterior surface of an expandable support;

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

delivering energy from the electrodes to the target site.