CA2645035A1 - Methods and apparatus for bilateral renal neuromodulation - Google Patents

Methods and apparatus for bilateral renal neuromodulation Download PDF

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Publication number
CA2645035A1
CA2645035A1 CA002645035A CA2645035A CA2645035A1 CA 2645035 A1 CA2645035 A1 CA 2645035A1 CA 002645035 A CA002645035 A CA 002645035A CA 2645035 A CA2645035 A CA 2645035A CA 2645035 A1 CA2645035 A1 CA 2645035A1
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modulating
neural
renal
patient
fiber
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CA002645035A
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French (fr)
Inventor
Denise Demarais
Hanson Gifford, Iii
Mark Deem
Douglas Sutton
Howard R. Levin
Mark Gelfand
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Medtronic AF Luxembourg SARL
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Ardian, Inc.
Denise Demarais
Hanson Gifford, Iii
Mark Deem
Douglas Sutton
Howard R. Levin
Mark Gelfand
Medtronic Ardian Llc
Medtronic Ardian Luxembourg S.A R.L.
Medtronic Af Luxembourg S.A.R.L.
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Application filed by Ardian, Inc., Denise Demarais, Hanson Gifford, Iii, Mark Deem, Douglas Sutton, Howard R. Levin, Mark Gelfand, Medtronic Ardian Llc, Medtronic Ardian Luxembourg S.A R.L., Medtronic Af Luxembourg S.A.R.L. filed Critical Ardian, Inc.
Publication of CA2645035A1 publication Critical patent/CA2645035A1/en
Abandoned legal-status Critical Current

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • A—HUMAN NECESSITIES
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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    • A61B2018/00505—Urinary tract
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    • A—HUMAN NECESSITIES
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    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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Abstract

Methods and apparatus are provided for bilateral renal neuromodulation, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Claims (60)

1. A method for bilateral renal neuromodulation, the method comprising:
modulating at least a first neural fiber that contributes to renal function of a first kidney of a patient; and modulating at least a second neural fiber that contributes to renal function of a second kidney of the patient, thereby achieving bilateral renal neuromodulation.
2. The method of claim 1, wherein modulating a first neural fiber that contributes to renal function of a first kidney of a patient further comprises modulating a right neural fiber that contributes to right renal function, and wherein modulating a second neural fiber that contributes to renal function of a second kidney of a patient further comprises modulating a left neural fiber that contributes to left renal function.
3. The method of claim 1, wherein modulating a first neural fiber that contributes to renal function of a first kidney of a patient further comprises modulating a left neural fiber that contributes to left renal function, and wherein modulating a second neural fiber that contributes to renal function of a second kidney of a patient further comprises modulating a right neural fiber that contributes to right renal function.
4. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises concurrently modulating the first and second neural fibers.
5. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises sequentially modulating the first and second neural fibers.
6. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises modulating the first neural fiber and modulating the second neural fiber via apparatus positioned within renal vasculature of the patient.
7. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises modulating the first neural fiber and modulating the second neural fiber via apparatus positioned external to renal vasculature of the patient.
8. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises modulating the first neural fiber and modulating the second neural fiber via apparatus positioned in proximity to renal vasculature of the patient.
9. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises modulating the first neural fiber and modulating the second neural fiber via apparatus positioned within renal vasculature of the patient and having a neuromodulatory element passed extravascularly.
10. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises modulating the first and second neural fibers via electric fields.
11. The method of claim 10, wherein modulating the first and second neural fibers via electric fields further comprises exposing the first and second neural fibers to pulsed electric fields.
12. The method of claim 10, wherein modulating the first and second neural fibers via electric fields further comprises exposing the first and second neural fibers to stimulation electric fields.
13. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises delivering a neuromodulatory agent to the first and second neural fibers.
14. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises at least partially denervating the first and second kidneys.
15. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises inducing an effect in the first and second neural fibers chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, action potential attenuation, action potential blockade, cytokine up-regulation alteration, and combinations thereof.
16. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises continuously modulating the first and second neural fibers.
17. The method of claim 1, wherein modulating the first neural fiber and modulating the second neural fiber further comprises intermittently modulating the first and second neural fibers.
18. Apparatus for bilateral renal neuromodulation, the apparatus comprising:
a first field applicator configured to be positioned proximate to at least a first neural fiber that contributes to right renal function;

a second field applicator configured to be positioned proximate to at least a second neural fiber that contributes to left renal function;
and a field generator coupled to the first and second field applicators, wherein the field generator is configured to provide a first signal to the first field applicator and a second signal to the second field applicator.
19. The apparatus of claim 18, wherein the first field applicator and the second field applicator comprise intravascular field applicators configured for placement within renal vasculature of the patient.
20. The apparatus of claim 18, wherein the first field applicator and the second field applicator comprise extravascular field applicators configured for placement in external proximity to renal vasculature of the patient.
21. The apparatus of claim 18, wherein the first field applicator and the second field applicator comprise intra-to-extravascular field applicators configured for extravascular placement via an intra-to-extravascular approach.
22. The apparatus of claim 18, wherein the first field applicator and the second field applicator comprise field applicators configured for a combination of placement within renal vasculature of the patient, placement in external proximity to renal vasculature of the patient or extravascular placement via an intra-to-extravascular approach.
23. The apparatus of claim 18, wherein the field generator further comprises a pulsed electric field generator.
24. The apparatus of claim 18, wherein the first field applicator and the second field applicator comprise electrodes configured for placement in proximity to the first and second neural fibers, and wherein the electrodes are coupled to the field generator for delivery of electric fields to the first and second neural fibers.
25. The apparatus of claim 24, wherein the first field applicator and the second field applicator comprise a first bipolar electrode pair and a second bipolar electrode pair.
26. The apparatus of claim 24, wherein the first field applicator and the second field applicator comprise a first monopolar electrode and a second monopolar electrode, the apparatus further comprising at least one ground pad configured for external attachment to the patient.
27. The apparatus of claim 24, wherein the first field applicator comprises a bipolar electrode pair and the second field applicator comprises a monopolar electrode, the apparatus further comprising a ground pad configured for external attachment to the patient.
28. The apparatus of claim 24, wherein the first field applicator comprises a monopolar electrode and the second field applicator comprises a bipolar electrode pair, the apparatus further comprising a ground pad configured for external attachment to the patient.
29. The apparatus of claim 18, wherein the field generator is configured to concurrently provide a first signal to the first field applicator and a second signal to the second field applicator.
30. The apparatus of claim 18, wherein the field generator is configured to sequentially provide a first signal to the first field applicator and a second signal to the second field applicator.
31. The apparatus of claim 18, wherein the field generator is configured to continuously provide a first signal to the first field applicator and a second signal to the second field applicator.
32. The apparatus of claim 18, wherein the field generator is configured to intermittently provide a first signal to the first field applicator and a second signal to the second field applicator.
33. A method for bilateral renal neuromodulation, the method comprising:
modulating neural fibers that contribute to right renal function of a patient; and modulating neural fibers that contribute to left renal function of the patient.
34. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises denervating the right and left kidneys of the patient.
35. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises inducing an effect in the neural fibers chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, action potential attenuation, action potential blockade, cytokine up-regulation alteration, and combinations thereof.
36. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises:
positioning modulating apparatus within right and left renal vasculature of the patient, and modulating the neural fibers with the modulating apparatus.
37. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises:
positioning modulating apparatus in a vicinity of right and left renal vasculature of the patient, and modulating the neural fibers with the modulating apparatus.
38. The method of claim 37, wherein positioning modulating apparatus in the vicinity of the right and left renal vasculature of the patient further comprises positioning the modulating apparatus within the patient external to the renal vasculature.
39. The method of claim 38, wherein positioning the modulating apparatus within the patient external to the renal vasculature further comprises positioning the modulating apparatus within the patient external to the renal vasculature via an intra-to-extravascular approach.
40. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises applying an electric field to the right and left neural fibers.
41. The method of claim 40, wherein applying an electric field to the right and left neural fibers further comprises applying a pulsed electric field to the right and left neural fibers.
42. The method of claim 40, wherein applying an electric field to the right and left neural fibers further comprises applying a stimulation electric field to the right and left neural fibers.
43. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises delivering a neuromodulatory agent to the right and left neural fibers.
44. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises concurrently modulating neural fibers that contribute to right and left renal function.
45. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises sequentially modulating neural fibers that contribute to right and left renal function.
46. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises continuously modulating neural fibers that contribute to right and left renal function.
47. The method of claim 33, wherein modulating neural fibers that contribute to right and left renal function further comprises intermittently modulating neural fibers that contribute to right and left renal function.
48. Apparatus for bilateral renal neuromodulation, the apparatus comprising:
a first drug delivery element configured to be positioned proximate to a first neural fiber that contributes to right renal function;
a second drug delivery element configured to be positioned proximate to a second neural fiber that contributes to left renal function; and a drug reservoir comprising a neuromodulatory agent, the drug reservoir coupled to the first and second drug delivery elements, wherein the drug reservoir is configured to deliver the neuromodulatory agent to the first drug delivery element and the second drug delivery element.
49. The apparatus of claim 48, wherein the drug reservoir comprises an implantable drug pump.
50. The apparatus of claim 48, wherein the drug reservoir comprises an external drug reservoir.
51. The apparatus of claim 48, wherein the drug reservoir is configured to concurrently deliver the neuromodulatory agent to the first drug delivery element and the second drug delivery element.
52. The apparatus of claim 48, wherein the drug reservoir is configured to sequentially deliver the neuromodulatory agent to the first drug delivery element and the second drug delivery element.
53. The apparatus of claim 48, wherein the drug reservoir is configured to continuously deliver the neuromodulatory agent to the first drug delivery element and the second drug delivery element.
54. The apparatus of claim 48, wherein the drug reservoir is configured to intermittently deliver the neuromodulatory agent to the first drug delivery element and the second drug delivery element.
55. An apparatus for concurrent bilateral renal neuromodulation, comprising:
a first stimulation catheter configure to be positioned at least proximate a first renal artery associated with a first kidney, the first stimulation catheter having at least one first electrode;
a second stimulation catheter configured to be positioned at least proximate a second renal artery associated with a second kidney, the second stimulation catheter having at least one second electrode; and a field generator connected to the first electrode and the second electrode.
56. The apparatus of claim 55, further comprising a guide catheter having a lumen and a bifurcated distal region, the guide catheter being configured to be positioned in a vessel, and wherein the first stimulation catheter is in the lumen and is configured to project out one side of the bifurcated distal region into the first renal artery and the second stimulation catheter is in the lumen and is configured to project out an opposing side of the bifurcated distal region into the second renal artery.
57. The apparatus of claim 55, further comprising dual guide catheters configured to be positioned in a vessel including a first guide catheter and a second guide catheter, and wherein the first stimulation catheter is in the first guide catheter and the second stimulation catheter is in the second guide catheter.
58. The apparatus of claim 55 wherein the first catheter is configured to be placed outside of the first renal artery and the second catheter is configured to be placed outside of the second renal artery.
59. The apparatus of claim 55 wherein the first electrode is configured to contact an inner wall of the first renal artery and the second electrode is configured to contact an inner wall of the second renal artery.
60. The apparatus of claim 55 wherein the first electrode is configured to pass through a wall of the first renal artery and the second electrode is configured to pass through a wall of the second renal artery.
CA002645035A 2006-03-06 2007-03-05 Methods and apparatus for bilateral renal neuromodulation Abandoned CA2645035A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/368,836 2006-03-06
US11/368,836 US8150519B2 (en) 2002-04-08 2006-03-06 Methods and apparatus for bilateral renal neuromodulation
PCT/US2007/063322 WO2007103879A2 (en) 2006-03-06 2007-03-05 Methods and apparatus for bilateral renal neuromodulation

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US (11) US8150519B2 (en)
EP (2) EP2604311A1 (en)
JP (1) JP2009528911A (en)
CN (1) CN101443072B (en)
CA (1) CA2645035A1 (en)
WO (1) WO2007103879A2 (en)

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US9456869B2 (en) 2016-10-04
US9814873B2 (en) 2017-11-14
WO2007103879A3 (en) 2008-04-24
US20060265014A1 (en) 2006-11-23
CN101443072A (en) 2009-05-27
WO2007103879A2 (en) 2007-09-13
US20120197198A1 (en) 2012-08-02
US20140288531A1 (en) 2014-09-25
US20140172054A1 (en) 2014-06-19
US9486270B2 (en) 2016-11-08
US10850091B2 (en) 2020-12-01
US10179235B2 (en) 2019-01-15
US20190175903A1 (en) 2019-06-13
CN101443072B (en) 2013-01-16
US9320561B2 (en) 2016-04-26
EP1996278A2 (en) 2008-12-03
US20150080885A1 (en) 2015-03-19
EP1996278A4 (en) 2010-06-02
US20170080214A1 (en) 2017-03-23
EP2604311A1 (en) 2013-06-19
US20160030736A1 (en) 2016-02-04
US9265558B2 (en) 2016-02-23
US9131978B2 (en) 2015-09-15
US20180078758A1 (en) 2018-03-22
US20140288545A1 (en) 2014-09-25
JP2009528911A (en) 2009-08-13
US9138281B2 (en) 2015-09-22
US8150519B2 (en) 2012-04-03
EP1996278B1 (en) 2017-08-30
US20160192984A1 (en) 2016-07-07

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