Devices, systems, and methods for diagnosis and treatment of overactive bladder

Patent metadata

Field	Value
Publication number	US-11564616-B2
Application number	US-201816229004-A
Country	US
Kind code	B2
Filing date	Dec 21, 2018
Priority date	Jun 14, 2012
Publication date	Jan 31, 2023
Grant date	Jan 31, 2023

Abstract

A system for modulating bladder function is disclosed. A system for evaluating the electrophysiological function of a bladder is disclosed. Methods for performing a controlled surgical procedure on a bladder are disclosed. A system for performing controlled surgical procedures in a minimally invasive manner is disclosed. An implantable device for monitoring and/or performing a neuromodulation procedure on a bladder is disclosed.

First claim

What is claimed is:

1. An apparatus, comprising:
an elongate delivery member configured to be inserted through a urethra and having a delivery member lumen;
a delivery sheath coupled to the delivery member and being configured to be inserted through the urethra and having a delivery sheath lumen;
a first retention feature coupled to the delivery sheath, the first retention feature being configured to maintain a position of the elongate delivery member with respect to the urethra;
a second retention feature coupled to the delivery sheath, the second retention feature being configured to maintain a position of the delivery sheath with respect to a bladder;
a treatment region coupled to the delivery member and positionable in the bladder, the treatment region in fluid communication with the lumen of the delivery member to deliver a therapeutic substance to bladder tissue;
a plurality of sensing tips mounted to the treatment region;
at least a first one of the plurality of sensing tips being disposed at a distal end of the treatment region and being configured to interface with the bladder tissue, the first sensing tip including: at least one microelectrode to deliver at least one of a stimulating and an ablating current to the bladder tissue to modulate bladder function; and at least one microsensor configured to convey one or more electrophysiological signals associated with the bladder tissue;
a microcircuit adjacent the treatment region and coupled with one or more of the plurality of sensing tips; and
a controller coupled to the delivery member, the controller being configured to actuate the delivery member to adjust a bias force of the first sensing tip against a wall of the bladder to maintain a position of the first sensing tip during a treatment applied via the treatment region;
wherein the bias force is determined based at least in part on comparing a first set of one or more measurements obtained from the first sensing tip and a second set of one or more measurements obtained from at least a second one of the plurality of sensing tips, the comparison of the first and second sets of one or more measurements characterizing a degree of contact between the first sensing tip and the wall of the bladder; and
wherein the microcircuit is configured:
to apply, via the at least one microelectrode of the first sensing tip, the stimulating current as the first sensing tip is moved along a surface of the wall of bladder;
to identify a given site on the surface of the wall of the bladder for application of the ablating current based at least in part on measurements of change in pressure from a baseline pressure level as the first sensing tip is moved along the surface of the wall of the bladder, the measurements of the change in pressure being obtained utilizing the at least one microsensor of the first sensing tip; and
to apply, via the at least one microelectrode of the first sensing tip, the ablating current at the given site.

2. The apparatus of claim 1 , wherein the at least one microelectrode is configured to ablate bladder tissue to modulate neural activity.

3. The apparatus of claim 2 , wherein the at least one microelectrode is a radio-frequency (RF) electrode.

4. The apparatus of claim 1 , wherein the at least one microelectrode is a needle electrode configured to penetrate the bladder tissue.

5. The apparatus of claim 1 , wherein at least one of the sensing tips is configured to mechanically stimulate the bladder tissue.

6. The apparatus of claim 1 , wherein the at least one microsensor is configured to convey one or more electrophysiological signals related to one or more of a water concentration, a tissue tone, an evoked potential, a remotely stimulated nervous activity, a pressure stimulated nervous response, an electrically stimulated movement, a sympathetic nervous activity, an electromyographic signal [EMG], a mechanomyographic signal [MMG], a local field potential, an electroacoustic event, a vasodilation, a bladder wall stiffness, a muscle sympathetic nerve activity [MSNA], a central sympathetic drive, a nerve traffic, or combinations thereof.

7. The apparatus of claim 1 , wherein the therapeutic substance is selected from a chemical, a drug substance, a neuromodulating substance, a neuroblocking substance, an acid, a base, a denervating agent, or a combination thereof.

8. The apparatus of claim 7 , wherein the at least one microsensor is configured to monitor the effect of the therapeutic substance on the target region.

9. The apparatus of claim 1 , wherein the treatment region is configured to transition from a collapsed condition to a deployed condition.

10. The apparatus of claim 9 , wherein the treatment region includes a balloon, the balloon having the at least one microelectrode and the at least one microsensor mounted to a surface thereof, the balloon configured to transition from the collapsed condition to the deployed condition, wherein, when in the deployed condition, at least one of the sensing tips are biased against the bladder tissue.

11. The apparatus of claim 10 , wherein the delivery member includes an electrode, the electrode configured to cooperate with the at least one microelectrode on the balloon to transmit said at least one of the stimulating and the ablating current to the bladder tissue.

12. The apparatus of claim 10 , wherein the balloon is in fluid communication with the lumen of the delivery member, the balloon configured to assume the deployed condition upon passage of the therapeutic substance through the lumen of the delivery member and into an interior of the balloon.

13. The apparatus of claim 12 , wherein the balloon includes one or more perforations configured to deliver the therapeutic substance to the bladder tissue.

14. The apparatus of claim 10 , wherein the at least one microsensor is configured to measure an interfacial pressure between the balloon and the bladder tissue.

15. The apparatus of claim 9 , wherein the treatment region includes an expandable cage, the expandable cage having the at least one microelectrode and the at least one microsensor mounted to a surface thereof, the expandable cage configured to transition from the collapsed condition to the deployed condition, wherein, when in the deployed condition, the sensing tips are biased against the bladder tissue.

16. The apparatus of claim 9 , wherein the treatment region includes a microfilament array having a plurality of microfilaments, at least one of the microfilaments including the at least one microelectrode and the at least one microsensor.

17. The apparatus of claim 16 , wherein the microfilaments comprise a shape memory material.

18. The apparatus of claim 1 , wherein the microcircuit is configured to communicate with the sensing tips and an extracorporeal system via digital signals such that the microcircuit is configured to at least one of exchange data, switch data, control data and control radio frequency pulse routing pertaining to selected ones of the sensing tips.

19. The apparatus of claim 1 , wherein the sensing tips are configured to map the bladder tissue at least one of before, during and subsequent to treatment.

20. The apparatus of claim 1 , wherein the sensing tips are configured to modulate at least one of micturition, incontinence, frequency, pain, nocturia and bladder capacity.

Assignees

• Autonomix Medical Inc

Inventors

• Toth Landy
• Schwartz Robert
• Robins David

Classifications

• A61B5/6848

  Needles · CPC title

• A61B2018/00226

  extending from a surface, i.e. Blisters · CPC title

• A61B18/1485

  having a short rigid shaft for accessing the inner body through natural openings · CPC title

• A61B2018/1465

  Deformable electrodes · CPC title

• A61B2018/00267

  having a basket shaped structure · CPC title