Neuromodulation catheters with nerve monitoring features for transmitting digital neural signals and associated systems and methods

Patent metadata

Field	Value
Publication number	US-9339332-B2
Application number	US-201314015835-A
Country	US
Kind code	B2
Filing date	Aug 30, 2013
Priority date	Aug 30, 2013
Publication date	May 17, 2016
Grant date	May 17, 2016

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.

First claim

I claim:

1. A neuromodulation catheter, comprising: a handle; an elongated shaft attached to the handle, the shaft having a distal portion and a proximal portion, wherein at least the distal portion is configured to be moved within a lumen of a blood vessel of a human patient; an array of contacts at the distal portion of the shaft, wherein the contacts are configured to detect analog neural signals from nerves along the blood vessel while the contacts are within the blood vessel; and a digitizer at the handle of the shaft, wherein the digitizer is configured to receive the analog neural signals from the contacts, digitize the analog neural signals into digital neural signals comprising electroneurogram (ENG) signals, and transmit the digital neural signals to a read/write module external to the patient, wherein the digitizer is configured to filter signals received from the contacts to differentiate the ENG signals from electromyogram (EMG) signals before transmitting the digital neural signals to the read/write module.

2. The neuromodulation catheter of claim 1 wherein the digitizer is configured to be detachable from the handle for reuse with other neuromodulation catheters.

3. The neuromodulation catheter of claim 1 wherein the digitizer is configured to filter signals received from the contacts using an amplifier assembly having a quasi-tripole (QT), true-tripole (TT), or adaptive-tripole (AT) arrangement to detect electroneurogram (ENG) signals.

4. The neuromodulation catheter of claim 1 wherein the digitizer comprises an analog to digital circuit.

5. The neuromodulation catheter of claim 1 wherein the digitizer has a cross-sectional dimension of about 9-25 mm 2 .

6. The neuromodulation catheter of claim 1 wherein the digitizer further comprises a telemetry module configured to wirelessly transmit the digitized signals from within the patient to the read/write module.

7. The neuromodulation catheter of claim 1 wherein the digitizer is inductively coupled to the read/write module.

8. The neuromodulation catheter of claim 1 , further comprising at least one energy delivery element at the distal portion of the elongated shaft, wherein the energy delivery element is configured to deliver neuromodulation energy to a target site within the blood vessel of the patient.

9. The neuromodulation catheter of claim 8 wherein the energy delivery element comprises an RF electrode.

10. The neuromodulation catheter of claim 1 wherein the contacts are further configured to deliver neuromodulation energy to the nerves along the blood vessel of the patient and detect the analog neural signals before or after the delivery of the neuromodulation energy.

11. The neuromodulation catheter of claim 1 , further comprising a support member at the distal portion of the shaft, wherein the support member has a spiral shape and is configured to contact an interior wall of the blood vessel when the support member is in a deployed state, wherein the contacts are spaced apart from each other along a length of the support member, and wherein the contacts are configured to deliver neuromodulation energy to the nerves along the blood vessel.

12. The neuromodulation catheter of claim 1 , further comprising a plurality of supports that define a basket structure at the distal portion of the shaft, wherein the contacts are arranged along the supports and, and wherein the supports are configured to contact an interior wall of the blood vessel when the supports are in a deployed state.

13. The neuromodulation catheter of claim 1 , further comprising a mesh structure at the distal portion of the shaft, wherein the mesh structure is configured to contact an interior wall of the blood vessel when the mesh structure is in a deployed state, and wherein the contacts are arranged along the mesh structure.

14. The neuromodulation catheter of claim 1 , further comprising a balloon at the distal portion of the shaft, wherein the balloon carries the contacts and is configured to place the contacts into contact with an interior wall of the blood vessel when expanded.

15. The neuromodulation catheter of claim 1 wherein the digitizer comprises: a telemetry module configured to wirelessly transmit the digitized signals from within the patient to the read/write module; an analog to digital circuit; and an amplifier assembly configured to filter the signals received from the contacts to differentiate the electroneurogram (ENG) signals from the electromyogram (EMG) signals before transmitting the digital neural signals to the read/write module; and wherein the contacts are further configured to deliver neuromodulation energy to the nerves along the blood vessel of the patient and detect the analog neural signals before or after the delivery of the neuromodulation energy.

16. A neuromodulation system, comprising: a neuromodulation catheter having a proximal portion and a distal portion configured to be moved through a lumen of a blood vessel of a human, wherein the neuromodulation catheter comprises: a plurality of contacts at the distal portion of the catheter and configured to detect analog neural measurements from within the blood vessel of the human; and a digitizer at the proximal portion of the catheter and operably coupled to the contacts, wherein the digitizer is configured to digitize the analog neural measurements and produce digital neural signals; and a read/write module communicatively coupled to the digitizer and configured to receive the digital signals of the neural measurements, wherein the digitizer comprises an amplifier assembly configured to filter signals received from the contacts to differentiate electroneurogram (ENG) signals from electromyogram (EMG) signals before transmitting digital neural signals to the read/write module.

17. The neuromodulation system of claim 16 wherein the digitizer and the read/write module are wirelessly coupled to each other.

18. The neuromodulation system of claim 16 wherein the distal portion of the neuromodulation catheter comprises at least one energy delivery element configured to deliver to therapeutically-effective neuromodulation energy to neural fibers at a target site within the blood vessel of the human.

19. The neuromodulation system of claim 18 wherein the contacts define the at least one energy delivery element such that the contacts are configured to deliver neuromodulation energy to neural fibers and detect neural measurements before and after delivering the neuromodulation energy.

20. The neuromodulation system of claim 16 wherein:
the neuromodulation catheter further comprises a plurality of energy delivery elements configured to deliver therapeutically-effective neuromodulation energy to neural fibers at a target site within the blood vessel of the human.

21. A neuromodulation system, comprising: a neuromodulation catheter having: an elongated shaft having a distal portion and a proximal portion, wherein at least the distal portion is configured to be moved within a lumen of a blood vessel of a human; an array of contacts at the distal portion of the shaft, wherein the contacts are configured to detect analog neural signals from within the blood vessel; and a transmitter operably coupled to the contacts; and a guide catheter configured to extend over the neuromodulation catheter and deliver at least the distal portion of the shaft to a target site within the blood vessel, wherein the guide catheter comprises: a digitizer configured to receive the analog neural signals from the transmitter, digi

Assignees

• Medtronic Ardian Luxembourg

Inventors

• Srivastava Nishant R

Classifications

• A61B5/388

  Nerve conduction study, e.g. detecting action potential of peripheral nerves · CPC title

• A61B18/1492 Primary

  having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence) · CPC title

• A61B2018/00434

  Neural system · CPC title

• A61B2018/00511

  Kidney · CPC title

• A61B17/320068

  using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745) · CPC title