NEUROMODULATION CATHETERS WITH NERVE MONITORING FEATURES FOR TRANSMITTING DIGITAL NEURAL SIGNALS AND ASSOCIATED SYSTEMS AND METHODS

• US 20160317053A1
• Filed: 04/11/2016
• Published: 11/03/2016
• Est. Priority Date: 08/30/2013
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Srivastava, Nishant R.
• Granted Patent: US 9,931,047 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• 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 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 Balloons
• 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 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Neuromodulation catheters with nerve monitoring features for transmitting digital neural signals and associated systems and methods are disclosed herein. A neuromodulation catheter configured in accordance with some embodiments of the present technology can include, for example, a handle and an elongated shaft attached to the handle. The shaft can have a proximal portion and a distal portion configured to be moved within a lumen of a blood vessel of a human patient. The neuromodulation catheter can further include an array of contacts at the distal portion of the shaft and a digitizer at the handle or the shaft. The contacts can be configured to detect analog neural signals from within the blood vessel. The digitizer can be configured to receive the analog neural signals from the contacts, digitize the analog neural signals into digital neural signals, and transmit the digital neural signals to a read/write module external to the patient.

Claims

1-35. -35 (canceled)

36. A method of detecting neural activity from within a blood vessel of a human, the method comprising:

delivering a distal portion of a neuromodulation catheter to a target site within the blood vessel of the human, wherein the distal portion comprises a plurality of contacts;

recording analog neural signals with the contacts;

digitizing recorded analog neural signals via a digitizer operably coupled to the contacts, wherein the digitizer is integrated with a proximal portion of the neuromodulation catheter; and

transmitting the digital neural signals to a read/write module external to the human.

37. The method of claim 36 wherein digitizing the recorded analog neural signals is performed while the neuromodulation catheter is within the human.

38. The method of claim 36, further comprising filtering the recorded analog neural signals with the digitizer to differentiate electroneurogram (ENG) signals from electromyogram (EMG) signals.

39. The method of claim 36, further comprising filtering the recorded analog neural signals with the digitizer using quasi-tripole (QT), true-tripole (TT), and/or adaptive-tripole (AT) signal processing techniques to detect electroneurogram (ENG) signals, wherein the analog neural signals are filtered before digitizing.

40. The method of claim 36, further comprising:

delivering neuromodulation energy to a target site within the blood vessel of the human via at least one energy delivery element, wherein the recording, digitizing, and transmitting steps are performed before and after delivery of the neuromodulation energy; and

comparing electroneurogram (ENG) signals recorded before and after delivery of the neuromodulation energy.

41. The method of claim 40, further comprising delivering neuromodulation energy at the target site for a second time when there is not a decrease in the ENG signal detected after energy delivery.

42. The method of claim 40 wherein the target site is a first target site, and wherein the method further comprises:

repositioning the energy delivery element to a second target site within the blood vessel; and

delivering neuromodulation energy to the second target site via the energy delivery element, wherein the recording, digitizing, and transmitting steps are performed before and after delivery of the neuromodulation energy.

43. The method of claim 36 wherein:

recording analog neural signals further comprises recording a plurality of analog neural signals taken during a plurality of different time intervals;

digitizing recorded analog neural signals further comprises digitizing each of the recorded neural signals;

transmitting the digital neural signals to the read/write module further comprises transmitting each of the digital neural signals to the read/write module after each time interval; and

averaging the digital neural signals at the read/write module to determine nerve activity proximate to the contacts.

44. The method of claim 36, further comprising comparing electroneurogram (ENG) signals taken at different time intervals.

45. The method of claim 36 wherein transmitting the digital neural signals comprises wirelessly transmitting the digital neural signals from within the human to the read/write module.

46. The method of claim 36 wherein transmitting the digital neural signals comprises inductively transmitting the digital neural signals from within the human to the read/write module.

47. The method of claim 36 wherein the neuromodulation catheter comprises a handle at the proximal portion of the neuromodulation catheter, and wherein the digitizer is at the handle.

48. The method of claim 36, further comprising delivering neuromodulation energy via at least one energy delivery element to a target site within the blood vessel of the human, wherein the recording, digitizing, and transmitting steps are performed before and/or after delivery of the neuromodulation energy.

49. The method of claim 48 wherein delivering the neuromodulation energy via the energy delivery element comprises delivering the neuromodulation energy via the plurality of contacts.

50. The method of claim 48 wherein the energy delivery element comprises a radiation emitter, and wherein delivering neuromodulation energy via the energy delivery element comprises delivering radiation to a vessel wall at the target site.

51. The method of claim 48 wherein the energy delivery element comprises an ultrasound transducer, and wherein delivering neuromodulation energy via the energy delivery element comprises delivering ultrasound waves to a vessel wall at the target site.

52. The method of claim 48 wherein the energy delivery element comprises a cryotherapeutic applicator, and wherein delivering neuromodulation energy via the energy delivery element comprises delivering cryotherapeutic cooling to a vessel wall at the target site.