CA2583463A1 - Apparatuses for renal neuromodulation - Google Patents
Apparatuses for renal neuromodulation Download PDFInfo
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- CA2583463A1 CA2583463A1 CA002583463A CA2583463A CA2583463A1 CA 2583463 A1 CA2583463 A1 CA 2583463A1 CA 002583463 A CA002583463 A CA 002583463A CA 2583463 A CA2583463 A CA 2583463A CA 2583463 A1 CA2583463 A1 CA 2583463A1
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- Prior art keywords
- electrode
- renal
- electric field
- pulsed electric
- vasculature
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- 230000004007 neuromodulation Effects 0.000 title claims abstract 9
- 230000005684 electric field Effects 0.000 claims abstract 37
- 238000000034 method Methods 0.000 claims abstract 31
- 238000004520 electroporation Methods 0.000 claims abstract 5
- 210000005166 vasculature Anatomy 0.000 claims 39
- 210000005036 nerve Anatomy 0.000 claims 25
- 230000004936 stimulating effect Effects 0.000 claims 9
- 238000012544 monitoring process Methods 0.000 claims 6
- 230000001537 neural effect Effects 0.000 claims 4
- 230000002889 sympathetic effect Effects 0.000 claims 4
- 238000001802 infusion Methods 0.000 claims 3
- 230000002427 irreversible effect Effects 0.000 claims 3
- 230000000638 stimulation Effects 0.000 claims 3
- 230000000694 effects Effects 0.000 claims 2
- 230000001939 inductive effect Effects 0.000 claims 2
- 230000003907 kidney function Effects 0.000 claims 2
- 210000002254 renal artery Anatomy 0.000 claims 2
- 238000000926 separation method Methods 0.000 claims 2
- 210000000709 aorta Anatomy 0.000 claims 1
- 235000019994 cava Nutrition 0.000 claims 1
- 238000002604 ultrasonography Methods 0.000 claims 1
- 206010007559 Cardiac failure congestive Diseases 0.000 abstract 1
- 206010019280 Heart failures Diseases 0.000 abstract 1
- 206010000891 acute myocardial infarction Diseases 0.000 abstract 1
- 208000020832 chronic kidney disease Diseases 0.000 abstract 1
- 230000002638 denervation Effects 0.000 abstract 1
- 208000028208 end stage renal disease Diseases 0.000 abstract 1
- 201000000523 end stage renal failure Diseases 0.000 abstract 1
- 230000004660 morphological change Effects 0.000 abstract 1
- 0 CC*C1C=*(C)C(C)C1 Chemical compound CC*C1C=*(C)C(C)C1 0.000 description 1
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Abstract
Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.
Claims (61)
1. Apparatus for renal neuromodulation, the apparatus comprising:
a pulsed electric field generator; and a device configured for percutaneous placement proximate a renal vasculature in a patient, wherein the device comprises an electrode electrically coupled to the pulsed electric field generator for delivering a pulsed electric field to renal nerves while the device is located proximate the renal vasculature.
a pulsed electric field generator; and a device configured for percutaneous placement proximate a renal vasculature in a patient, wherein the device comprises an electrode electrically coupled to the pulsed electric field generator for delivering a pulsed electric field to renal nerves while the device is located proximate the renal vasculature.
2. The apparatus of claim 1, wherein the device is configured for placement adjacent to the renal vasculature, and wherein the electrode is configured to deliver the pulsed electric field to renal nerves while the device is at least partially located adjacent to the renal vasculature.
3. The apparatus of claim 1, wherein the device is configured for percutaneous intravascular placement in the renal vasculature, and wherein the electrode is configured to deliver the pulsed electric field to renal nerves while the device is at least partially located within the renal vasculature.
4. The apparatus of claim 1, wherein the pulsed electric field generator is configured to produce a pulsed electric field that induces irreversible electroporation in the renal nerves.
5. The apparatus of claim 3, wherein the device is configured to be arranged in (a) a reduced delivery configuration for movement within the patient and (b) an expanded treatment configuration for delivering the pulsed electric field to the renal nerves.
6. The apparatus of claim 5, wherein the electrode is configured to physically contact a wall of the renal vasculature.
7. The apparatus of claim 6, wherein the electrode is chosen from the group consisting of expandable helical electrodes, expandable ring electrodes, expandable point contact electrodes and combinations thereof.
8. The apparatus of claim 5, wherein the device further comprises an expandable centering element configured to physically contact a wall of the renal vasculature.
9. The apparatus of claim 8, wherein the expandable centering element is chosen from the group consisting of inflatable balloons, expandable baskets and combinations thereof.
10. The apparatus of claim 8, wherein the electrode is located on the expandable centering element and configured to physically contact the wall of the renal vasculature.
11. The apparatus of claim 8, wherein the device further comprises a shaft and the electrode is located along the shaft of the device.
12. The apparatus of claim 11, wherein the device further comprises a shaft longitudinally aligned with the centering element and the electrode is located on the shaft.
13. The apparatus of claim 8, wherein the electrode comprises a first electrode located proximal of the centering element and the device further comprises a second electrode located distal of the centering element, and wherein the first and second electrodes are a bipolar electrode pair.
14. The apparatus of claim 8, wherein the centering element is configured to electrically insulate a segment of the renal vasculature and direct the pulsed electric field to the renal nerves.
15. The apparatus of claim 3, wherein the electrode is a first electrode and the device further comprises a catheter having a guide wire lumen and a second electrode configured for movement through the guide wire lumen.
16. The apparatus of claim 15, wherein the second electrode is electrically coupled to the pulsed electric field generator and is configured for use in a bipolar fashion with the first electrode of the device.
17. The apparatus of claim 1, wherein the electrode comprises a first electrode and the device further comprises a second electrode to define a bipolar electrode pair.
18. The apparatus of claim 1, wherein the electrode comprises a first dynamically controllable electrode and the device further comprises a plurality of additional dynamically controllable electrodes that are electrically coupled to the pulsed electric field generator.
19. The apparatus of claim 1, wherein the electrode and the pulsed electric field generator are further configured to deliver a stimulation electric field.
20. The apparatus of claim 3, wherein the device is configured to controllably move the electrode radially relative to a wall of the renal vasculature.
21. The apparatus of claim 1, wherein the pulsed electric field generator is configured to produce a pulsed electric field that induces electrofusion in the renal nerves.
22. The apparatus of claim 3, wherein the electrode is configured for partial or complete passage across a wall of the renal vasculature.
23. The apparatus of claim 22, wherein the electrode is configured to at least partially encircle a renal artery of the patient.
24. The apparatus of claim 23, further comprising an infusion element configured to infuse agents across the wall of the renal vasculature.
25. The apparatus of claim 24, wherein the infusion element is configured to create a working space for advancement of the at least one electrode.
26. The apparatus of claim 1, wherein the electrode comprises an active electrode, and the device further comprises a return electrode that together define a bipolar electrode pair in which at least one of the active electrode and the return electrode is configured for dynamic movement to vary a longitudinal separation distance between the active and return electrodes of the bipolar electrode pair.
27. The apparatus of claim 1, wherein the device is configured for infusion or aspiration.
28. The apparatus of claim 1, wherein the device comprises an element for monitoring the response of at least one physiological parameter to stimulation of the renal nerves.
29. The apparatus of claim 28, wherein the element is chosen from the group consisting of Doppler ultrasound sensors, thermocouples, pressure sensors and combinations thereof.
30. The apparatus of claim 1, wherein the device is configured to orient a longitudinal portion of the pulsed electric field with a longitudinal dimension of at least one of the renal nerves and the renal vasculature.
31. The apparatus of claim 1 wherein the electrode comprises an active electrode and the device further comprises a ground electrode configured for exterior attachment to the patient such that the active electrode is configured to deliver the pulsed electric field to the renal nerves in a monopolar fashion.
32. The apparatus of claim 15, wherein the second electrode comprises a guide wire.
33. A method for renal neuromodulation, the method comprising:
percutaneously advancing an electrode proximate to a renal vasculature of a patient; and delivering a pulsed electric field via the electrode to modulate a renal nerve of the patient.
percutaneously advancing an electrode proximate to a renal vasculature of a patient; and delivering a pulsed electric field via the electrode to modulate a renal nerve of the patient.
34. The method of claim 33, wherein advancing the electrode proximate the renal vasculature further comprises advancing the electrode adjacent the renal vasculature.
35. The method of claim 33, wherein advancing the electrode proximate the renal vasculature further comprises advancing the electrode into the renal vasculature.
36. The method of claim 33, wherein modulating the renal nerve of the patient further comprises inducing irreversible electroporation in the renal nerve.
37. The method of claim 33, wherein modulating the renal nerve of the patient further comprises denervating the renal nerve.
38. The method of claim 33 further comprising:
electrically stimulating the renal nerve; and monitoring a response of a physiological parameter to the stimulation.
electrically stimulating the renal nerve; and monitoring a response of a physiological parameter to the stimulation.
39. The method of claim 38, wherein electrically stimulating the renal nerve further comprises intravascularly electrically stimulating the renal nerve.
40. The method of claim 39, wherein intravascularly electrically stimulating the renal nerve further comprises intravascularly electrically stimulating the renal nerve with the electrode.
41. The method of claim 38, wherein electrically stimulating and monitoring further comprises electrically stimulating and monitoring before delivering the pulsed electric field in order to identify a location suitable for delivering the pulsed electric field.
42. The method of claim 38, wherein electrically stimulating and monitoring further comprises electrically stimulating and monitoring after delivering the pulsed electric field in order to determine an extent of modulation of the renal nerve induced by the pulsed electric field.
43. The method of claim 33, wherein advancing the electrode proximate the renal vasculature further comprises advancing a pair of bipolar electrodes proximate the renal vasculature; and wherein delivering the pulsed electric field via the electrode further comprises delivering the pulsed electric field across the pair of bipolar electrodes.
44. The method of claim 43 further comprising centering the pair of bipolar electrodes within the renal vasculature.
45. The method of claim 44 further comprising contacting a wall of the renal vasculature with at least one of the pair of bipolar electrodes.
46. The method of claim 45 further comprising impeding electrical conduction in a segment of the patient's renal vasculature disposed between the pair of bipolar electrodes.
47. The method of claim 43 further comprising dynamically altering a longitudinal separation distance between active and return electrodes of the pair of bipolar electrodes.
48. The method of claim 43 further comprising focusing the pulsed electric field by controllably moving the electrode relative to a wall of the renal vasculature.
49. The method of claim 33 further comprising orienting the pulsed electric field with a longitudinal dimension of at least one of the renal vasculature and renal nerve.
50. The method of claim 35 further comprising passing the electrode at least partially across a wall of the renal vasculature before delivering the pulsed electric field.
51. The method of claim 50, wherein the electrode passed partially or completely across the wall of the renal vasculature at least partially encircles a renal artery of the patient before delivering the pulsed electric field.
52. The method of claim 35 further comprising infusing an agent into the renal vasculature to protect or repair cells of the renal vasculature from effects of the pulsed electric field.
53. The method of claim 35 further comprising infusing an agent into the renal vasculature to alter the susceptibility of cells to electroporation.
54. The method of claim 33 further comprising protecting or repairing cells of the renal vasculature from effects of the pulsed electric field.
55. The method of claim 33, wherein modulating the renal nerve of the patient further comprises inducing electrofusion in the renal nerve.
56. A method for renal neuromodulation, the method comprising:
percutaneously advancing an electrode proximate a renal vasculature of a patient; and delivering a pulsed electric field through the electrode to induce irreversible electroporation in a renal nerve of the patient.
percutaneously advancing an electrode proximate a renal vasculature of a patient; and delivering a pulsed electric field through the electrode to induce irreversible electroporation in a renal nerve of the patient.
57. Apparatus for renal neuromodulation, the apparatus comprising:
a pulsed electric field generator; and a device configured for percutaneous placement in an intravascular location within a patient proximate to a sympathetic neural path associated with renal function, wherein the device comprises an electrode electrically coupled to the pulsed electric field generator for delivering a pulsed electric field to the sympathetic neural path while the device is at the vasculature location.
a pulsed electric field generator; and a device configured for percutaneous placement in an intravascular location within a patient proximate to a sympathetic neural path associated with renal function, wherein the device comprises an electrode electrically coupled to the pulsed electric field generator for delivering a pulsed electric field to the sympathetic neural path while the device is at the vasculature location.
58. A method for renal neuromodulation, comprising:
percutaneously advancing an electrode through the vasculature of a patient until the electrode is located proximate to a sympathetic neural path associated with renal function; and delivering a pulsed electric field via the electrode to modulate neural activity along the sympathetic path.
percutaneously advancing an electrode through the vasculature of a patient until the electrode is located proximate to a sympathetic neural path associated with renal function; and delivering a pulsed electric field via the electrode to modulate neural activity along the sympathetic path.
59. The method of claim 58 wherein percutaneously advancing the electrode through the vasculature comprises positioning the electrode in the aorta of the patient.
60. The method of claim 58 wherein percutaneously advancing the electrode through the vasculature comprises positioning the electrode in the cava of the patient.
61. The method of claim 58 wherein percutaneously advancing the electrode through the vasculature comprises positioning the electrode in the renal vasculature of the patient.
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