CATHETER APPARATUSES HAVING EXPANDABLE MESH STRUCTURES FOR RENAL NEUROMODULATION AND ASSOCIATED SYSTEMS AND METHODS

• US 20120101413A1
• Filed: 10/20/2011
• Published: 04/26/2012
• Est. Priority Date: 10/20/2010
• Status: Abandoned Application

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Griswold, Erik, Zarins, Denise, Aboytes, Maria G., Beetel, Robert J.
• Application Number:
  US13/278,081
• Publication Number:
  US 20120101413A1
• Time in Patent Office: Days
• US Class Current: 601/3
• 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 2018/00029 open
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00886 Duration
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 7/022 intracavitary
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

Catheter apparatuses having expandable mesh structures and associated systems and methods for intravascular renal neuromodulation are disclosed herein. A catheter treatment device includes an expandable mesh structure configured to position an energy delivery element in contact with a renal artery via an intravascular path. The mesh structure can assume an expanded configuration for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function. A collapsed configuration may facilitate insertion and/or removal of the catheter or repositioning of the energy delivery element within the renal artery.

Claims

1. A catheter apparatus for treatment of a human patient via renal denervation, the catheter apparatus comprising:

an elongated shaft having a proximal portion and a distal portion, wherein the distal portion of the shaft is configured for intravascular delivery to a renal artery of the patient;

a mesh structure at the distal portion of the elongated shaft, wherein the mesh structure is configured to vary between a delivery configuration and a deployed configuration, and wherein the mesh structure comprises interstitial spaces that allow blood to flow through the mesh structure when in the deployed configuration; and

an energy delivery element associated with the mesh structure, wherein the energy delivery element is configured to thermally inhibit neural communication along the renal artery, and wherein, in the deployed configuration, the mesh structure is configured to contact a wall of the renal artery and position the energy delivery element in stable contact with the renal artery wall.

2. The catheter apparatus of claim 1 wherein the mesh structure comprises a conformable tube, and wherein the interstitial spaces comprise holes or cutouts in the conformable tube.

3. The catheter apparatus of claim 1 wherein the mesh structure comprises an insulating material configured to insulate against energy delivered by the energy delivery element.

4. The catheter apparatus of claim 1 wherein the mesh structure comprises an electrically conductive material, and wherein the electrically conductive material comprises a portion of the energy delivery element.

5. The catheter apparatus of claim 4 wherein the electrically conductive material is covered only in part by an electrically insulating material.

6. The catheter apparatus of claim 1 wherein the mesh structure includes a proximal portion and a distal portion, and wherein at least one of the proximal portion or the distal portion of the mesh structure is coupled to the elongated shaft via generally flexible wires.

7. The catheter apparatus of claim 1 wherein:

the mesh structure includes a proximal portion and a distal portion;

the proximal portion of the mesh structure is coupled to the distal portion of the elongated shaft; and

the distal portion of the mesh structure is coupled to a second shaft, and wherein the mesh structure is configured to vary between the delivery configuration and the deployed configuration upon relative motion of the elongated shaft and the second shaft.

8. The catheter apparatus of claim 7 wherein the second shaft comprises a lumen or receptacle configured to receive a distal portion of a guide wire.

9. The catheter apparatus of claim 1 wherein the elongated shaft comprises a lumen configured to receive a guide wire.

10. The catheter apparatus of claim 1, further comprising a pull wire coupled to the mesh structure and configured to actuate the mesh structure between the deployed configuration and the delivery configuration.

11. The catheter apparatus of claim 10, further comprising a handle coupled to the proximal end of the elongated shaft, wherein the handle comprises an actuatable element configured to adjust tension in the pull wire.

12. The catheter apparatus of claim 1, further comprising a sheath or guide catheter configured to deliver the mesh structure into the renal artery.

13. The catheter apparatus of claim 1 wherein the elongated shaft, the mesh structure, and the energy delivery element are configured for intravascular delivery into the renal artery via a 6 French or smaller guide catheter.

14. The catheter apparatus of claim 1 wherein the mesh structure comprises one or more heat-set mesh points or protrusions.

15. The catheter apparatus of claim 1 wherein the mesh structure comprises one or more annular mesh rings.

16. The catheter apparatus of claim 1 wherein the mesh structure is braided or woven.

17. The catheter apparatus of claim 1 wherein the energy delivery element is configured to apply at least one of radiofrequency energy, microwave energy, ultrasound energy, laser energy, electromagnetic energy, or thermal energy to the renal artery.

18. The catheter apparatus of claim 1 wherein the energy delivery element is configured to affect an area comprising at least 30% of a circumference of the renal artery wall when the catheter apparatus is inserted in the patient and when the mesh structure is deployed against the renal artery.

19. The catheter apparatus of claim 1 wherein the energy delivery element is configured to affect an area comprising a circumference of the renal artery wall when the catheter apparatus is inserted in the patient and when the mesh structure is deployed against the renal artery.

20. The catheter apparatus of claim 1 wherein the mesh structure comprises a radiopaque material.

21. The catheter apparatus of claim 1, further comprising a sensor associated with the energy delivery element, wherein the sensor is configured to monitor a parameter of at least one of the apparatus, blood, or the renal artery.

22. The catheter apparatus of claim 1 wherein the at least one energy delivery element comprises two energy delivery elements that are spaced apart from each other along a longitudinal axis of the elongated shaft and circumferentially offset along the circumference of the mesh structure.

23. The catheter apparatus of claim 22 wherein the two energy delivery elements are at least 5 mm apart from one another along the longitudinal axis of the elongated shaft when the mesh structure is in a fully deployed configuration.

24. The catheter apparatus of claim 1 wherein a length of the mesh structure relative to the elongated shaft is less when the mesh structure is in the deployed configuration relative to when the mesh structure is in the delivery configuration.

25. The catheter apparatus of claim 1 wherein the mesh structure has a length in a fully deployed configuration from about 50% to about 80% of a length of the mesh structure in the delivery configuration.

26. The catheter apparatus of claim 1 wherein a length of the mesh structure when in a fully deployed configuration is less than about 30 mm and the length of the mesh structure when in the delivery configuration is less than about 40 mm.

27. The catheter apparatus of claim 1 wherein the mesh structure is mounted to the distal end of the elongated shaft.

28. The catheter apparatus of claim 1 wherein the mesh structure is located distally from the distal end of the elongated shaft.

29. The catheter apparatus of claim 1 wherein the mesh structure in the deployed configuration is configured to apply a radial force to the renal artery wall.

30. The catheter apparatus of claim 29 wherein the radial force is no more than about 300 mN/mm.

31. The catheter apparatus of claim 1 wherein a largest diameter of the mesh structure in a fully deployed configuration is from about 8 mm to about 10 mm.

32. The catheter apparatus of claim 1 wherein the mesh structure in a fully deployed configuration has a largest diameter from about 5 mm to about 8 mm.

33. The catheter apparatus of claim 1 wherein the mesh structure in a fully deployed configuration has a largest diameter from about 3 mm to about 5 mm.

34. A system, comprising:

a renal denervation catheter comprising—

a mesh structure disposed proximate to a distal portion of an elongated catheter body, wherein the mesh structure comprises interstitial spaces that allow blood to flow through the mesh structure when the renal denervation catheter is inserted into a renal artery of a human patient, and wherein a length of the mesh structure relative to the elongated catheter body decreases as the mesh structure expands from a delivery arrangement to a deployed arrangement; and

at least one energy delivery element associated with the mesh structure, wherein less than 50% of a total exposed surface area of the energy delivery element is configured to contact a wall of the renal artery; and

an energy source electrically coupled to the energy delivery element.

35. The system of claim 34, comprising a sensor associated with the energy delivery element, wherein the sensor is configured to monitor a parameter of at least one of the catheter, blood or the renal artery.

36. The system of claim 35 wherein the sensor comprises a temperature sensor, impedance sensor, pressure sensor, flow sensor, optical sensor or micro sensor.

37. The system of claim 35, further comprising a control mechanism configured to alter the energy delivered by the energy delivery element in response to the monitored parameter.

38. The system of claim 37 wherein the control mechanism is configured to provide an output related to placement or contact of the energy delivery element based at least in part upon a signal from the sensor.

39. The system of claim 35 wherein the sensor comprises an impedance sensor and wherein a change in impedance over a predetermined threshold indicates a lack of contact with a wall of the renal artery.

40. A method of manufacturing a medical device for catheter-based renal neuromodulation, the method comprising:

providing an elongated shaft having a proximal portion and a distal portion;

disposing a mesh structure on a distal portion of the elongated shaft, wherein the mesh structure comprises interstitial spaces that allow blood to flow through the mesh structure when the device is inserted into a renal artery, and wherein a density of the mesh varies within the mesh structure; and

disposing at least one energy delivery element on the mesh structure.

41. A catheter apparatus, comprising:

an elongated shaft having a proximal portion and a distal portion;

a mesh structure disposed proximate to the distal portion of the elongated shaft and configured to permit blood flow through the mesh structure when inserted into a renal artery of a human patient, wherein the mesh structure is moveable between a low-profile arrangement and a fully deployed arrangement, and wherein the mesh structure has a diameter no greater than about 10 mm while in the fully deployed configuration; and

at least one energy delivery element associated with the mesh structure,

wherein when the mesh structure is deployed within the renal artery to a diameter that is less than the largest diameter of the fully deployed configuration, the mesh structure is configured to contact an inner wall of the renal artery and position the energy delivery element in stable contact with the inner wall.

42. The catheter apparatus of claim 41 wherein the mesh structure is braided or woven.

43. The catheter apparatus of claim 41 wherein the mesh structure comprises a conformable tube having interstitial spaces comprising holes or cutouts in the conformable tube.

44. The catheter apparatus of claim 41 wherein the mesh structure includes a proximal portion and a distal portion, and wherein the mesh structure is coupled to the elongated shaft at only one of the proximal or distal portions of the mesh structure.

45. The catheter apparatus of claim 44 wherein the proximal portion of the mesh structure is coupled to the distal portion of the elongated shaft.

46. The catheter apparatus of claim 44 wherein the distal portion of the mesh structure is coupled to a wire extending from the distal portion of the elongated shaft, and wherein the proximal portion of the mesh structure is not coupled to the elongated shaft.

47. The catheter apparatus of claim 41 wherein the largest diameter of the fully expanded configuration is from about 8 mm to about 10 mm, and wherein the diameter that is less than the largest diameter of the fully expanded configuration is about 6 mm or less.

48. The catheter apparatus of claim 41 wherein the mesh structure does not substantially distend or expand a diameter of the renal artery when the mesh structure is expanded to contact the wall of the renal artery.

49. The catheter apparatus of claim 41 wherein the at least one energy delivery element comprises a plurality of energy delivery elements, and wherein each individual energy delivery element is electrically connected to the other energy delivery elements.

50. The catheter apparatus of claim 41 wherein the at least one energy delivery element comprises a plurality of energy delivery elements, and wherein each individual energy delivery element is electrically isolated from the other energy delivery elements.

51. A catheter apparatus for intravascular modulation of renal nerves, the catheter apparatus comprising:

an elongated shaft having a proximal portion and a distal portion;

an expandable mesh structure disposed proximate to the distal portion of the elongated shaft, wherein the mesh structure is movable between a collapsed delivery configuration and a deployed configuration;

at least one energy delivery element carried by the mesh structure; and

a fluid redirecting element attached to one or both of the elongated shaft or the mesh structure and disposed within at least a portion of the mesh structure.

52. The catheter apparatus of claim 51 wherein:

the mesh structure comprises a first expandable mesh structure having a first largest diameter; and

the fluid redirecting element comprises a second expandable mesh structure having a second largest diameter smaller than the first largest diameter when both the first and the second mesh structures are in a fully expanded configuration.

53. The catheter apparatus of claim 52 wherein the first mesh structure has a first mesh density and the second mesh structure has a second mesh density greater than the first mesh density.

54. The catheter apparatus of claim 52 wherein the fluid redirecting element comprises a porous structure having pores that permit at least some fluid to flow through the fluid redirecting element.

55. The catheter apparatus of claim 54 wherein the porous structure comprises a porous foam or porous polymer.

56. The catheter apparatus of claim 54 wherein the porous structure is configured to swell within the mesh structure when the porous structure is filled with fluid.

57. The catheter apparatus of claim 51 wherein the fluid redirecting element comprises a resilient material.

58. The catheter apparatus of claim 51 wherein the fluid redirecting element comprises surface features configured to direct the flow of fluid through the mesh structure.

59. The catheter apparatus of claim 58 wherein the surface features comprise fins, protrusions, rifling, ribs, grooves, or channels.

60. The catheter apparatus of claim 51 wherein the mesh structure has a first length along a longitudinal axis, and wherein the fluid redirecting element has a second length along the longitudinal axis that is more than 50% of the first length.

61. The catheter apparatus of claim 51 wherein the fluid redirecting element has a largest diameter of about 3 mm or less.

62. The catheter apparatus of claim 51 wherein an axis through the energy delivery element and substantially orthogonal to an axis of the elongated shaft intersects the fluid redirecting element.

63. The catheter apparatus of claim 62, further comprising a second energy delivery element associated with the mesh structure, wherein an axis through the second energy delivery element and substantially orthogonal to the axis of the elongated shaft intersects the fluid redirecting element.

64. The catheter apparatus of claim 51 wherein the fluid redirecting element comprises a lumen or receptacle configured to receive a guide wire.

65. A catheter apparatus for intravascular modulation of renal nerves, the catheter apparatus comprising:

an elongated shaft having a proximal portion and a distal portion;

a mesh structure disposed proximate to the distal portion of the elongated shaft and configured to permit fluid flow through the mesh structure when the mesh structure is in an expanded configuration; and

at least one energy delivery element coupled to the mesh structure, wherein less than 50% of a total exposed surface area of the energy delivery element is configured to contact a renal artery.

66. The catheter apparatus of claim 65 wherein the energy delivery element comprises a ribbon electrode.

67. The catheter apparatus of claim 66 wherein the ribbon electrode is woven into the mesh structure.

68. The catheter apparatus of claim 66 wherein at least one surface of the energy delivery element comprises protrusions, grooves, and or channels.

69. The catheter apparatus of claim 68 wherein at least one surface of the energy delivery device comprises fins or ribs.

70. A catheter apparatus for intravascular modulation of renal nerves, the catheter apparatus comprising:

an elongated shaft extending along an axis, the elongated shaft having a proximal portion and a distal portion;

a mesh structure disposed proximate to the distal portion of the elongated shaft, wherein the mesh structure comprises a plurality of interstitial spaces that allow blood to flow through the mesh structure when the catheter apparatus is inserted into a renal artery, and wherein a density of the mesh varies within the mesh structure; and

at least one energy delivery element associated with the mesh structure.

71. The catheter apparatus of claim 70 wherein the mesh structure comprises a braided structure, and wherein a pick count of the braided structure is lower in a portion of the mesh structure in direct contact with the energy delivery element relative to another portion of the mesh structure not in direct contact with the energy delivery element.

72. The catheter apparatus of claim 70 wherein a circumferential section of the mesh structure that includes the energy delivery element comprises larger interstitial spaces relative to an adjacent circumferential section of the mesh structure.

73. The catheter apparatus of claim 70 wherein the mesh structure comprises an electrically conductive material covered only in part by an electrically insulating material, and wherein an uncovered portion of the electrically conductive material comprises the energy delivery element.

74. The catheter apparatus of claim 70, further comprising a second expandable mesh structure disposed proximate to the distal end of the elongated shaft, wherein the second expandable mesh structure comprises a second energy delivery element.

75. The catheter apparatus of claim 74 wherein the second energy delivery element is electrically insulated from the first energy delivery element.