IP Library Granted Patent US 11,471,180
Granted Patent B2
US 11,471,180 · App. 16/751,096 · Granted Oct 18, 2022

Devices and methods for treating conditions caused by afferent nerve signals

Inventors: Edwin J. Hlavka (Minneapolis, MN); Eric Whitbrook (St. Paul, MN); Peter T. Keith (Lanesboro, MN); Thomas V. Ressemann (Edina, MN)
Assignee: Hologic, Inc.
A61B17/320016A61B1/00087A61B1/307A61B17/3201A61B2017/00353A61B2017/00805A61B2017/2932A61B2017/306A61B2217/005
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Quick Facts
Patent No.
US 11,471,180
App. No.
16/751,096
Granted
Oct 18, 2022
Kind
B2
Abstract

A method for treating OAB in a female patient includes positioning a visualization scope in the patent's vagina; advancing a guide wire through a working channel of a visualization scope, until a tissue penetrating distal tip of the guide wire advances out of the working channel and penetrates a wall of the superior portion of the vagina; continuing to advance the guidewire tip submucosally through the wall of the vagina, until it is positioned within tissue of the bladder trigone; advancing a balloon dilation catheter over the guidewire until a balloon carried on a distal end portion of the balloon dilation catheter is positioned proximate the distal tip of the guidewire within the bladder trigone tissue; and inflating said balloon to form a first dissection plane between separated layers of tissue within the bladder trigone.

Claims (36)

1. A method of creating at least one dissection plane within a wall of a bladder trigone of a patient, the method comprising:

advancing a visualization scope through a vagina of the patient until a distal end portion of the scope is positioned in the patient's vagina, the scope including a working channel therethrough;

advancing a guide wire through the working channel, until a tissue penetrating distal tip of the guide wire is advanced out an open distal end of the working channel and penetrates a wall of the superior portion of the vagina;

advancing the distal tip of the guidewire submucosally through the wall of the vagina until the distal tip of the guidewire is positioned within tissue of the bladder trigone;

advancing a balloon dilation catheter over the guidewire until a balloon carried on a distal end portion of the balloon dilation catheter is positioned proximate the distal tip of the guidewire within the bladder trigone tissue; and

while the balloon is within the wall of the bladder trigone, inflating said balloon to form a first dissection plane between separated layers of tissue within the bladder trigone.

2. The method of claim 1 , wherein a distal end portion of the guide wire has a pre-formed curve to facilitate positioning of the balloon at a desired depth in the bladder trigone tissue.

3. The method of claim 1 , wherein the balloon is inflated at a first location in the bladder trigone, the method further comprising

after said inflating, deflating the balloon;

relocating the balloon dilation catheter so that the balloon is positioned at a second location in the bladder trigone; and

re-inflating the balloon to (i) form a second dissection plane between separated layers of tissue within the bladder trigone or (ii) extend the first dissection plane between the separated layers of tissue within the bladder trigone.

4. The method of claim 1 , wherein said first dissection plane is formed between layers of tissue having a natural separability.

5. The method of claim 1 , wherein said advancing the visualization scope through a vagina of the patient comprises positioning the distal end portion of the scope in the patient's vagina so that the open distal end of the working channel is adjacent a targeted entry site on the vaginal wall spaced apart from the trigone through which the distal tip of the guidewire is intended to penetrate.

6. The method of claim 1 , wherein the balloon dilation catheter is positioned within the bladder trigone tissue based on markers provided on the guidewire.

7. A method of creating at least one dissection plane within a wall of a bladder trigone, the method comprising:

placing a cutting tool at the bladder trigone via a vagina, said cutting tool including a suction paddle and a blade spaced apart from and generally parallel to a surface of said suction paddle;

applying suction to said suction paddle to engage tissue of the bladder trigone; and,

forming a dissection plane between separated layers of tissue within the wall of the bladder trigone by advancing said blade through said engaged tissue.

8. The method of claim 7 , wherein said dissection plane is formed between layers of tissue having a natural separability.

9. The method of claim 7 , wherein the blade is advanced generally parallel to the suction paddle surface.

10. The method of claim 7 , further comprising conducting radiofrequency (RF) energy between the blade and the suction head.

11. The method of claim 7 , wherein the blade is first advanced along a longitudinal axis of the cutting tool, and then the blade is advanced in a lateral direction relative to the longitudinal axis.

12. The method of claim 11 , wherein said advancing said blade in a lateral direction comprises translating the blade side-to-side about a pivot point, and wherein said blade is advanced out of a lumen of the cutting instrument into the bladder trigone such that the pivot point is located within a distal portion of the lumen to limit the lateral translation of the blade.

13. The method of claim 7 , wherein placing a cutting tool at the bladder trigone via a vagina comprises places the cutting tool at a first location on the bladder trigone, the method further comprising repositioning the cutting tool at a different location in the bladder trigone and advancing the blade to either

form an additional dissection plane between separated layers of tissue, or

extend the dissection plane between the separated layers of tissue.

14. The method of claim 7 , wherein the blade comprises a first laterally extendable blade, and wherein the cutting tool further includes a second laterally extendable blade, the method comprising moving the first and second blades from a closed configuration to an open configuration after the cutting tool is placed in the bladder trigone, wherein both the first and second blades are advanced through said engaged tissue to form the dissection plane such that the dissection plan is wider than the cutting device.

15. A method of treating over active bladder, the method comprising:

advancing a cutting device through a vagina and into tissue via a superior surface of the vagina such that a portion of the cutting device including a cutting blade extends into tissue between a surface of the trigone region of the bladder and the vaginal surface; and

creating a dissection plane between separated layers of tissue within the tissue between the surface of the trigone region of the bladder and the vaginal surface by advancing the cutting blade within the bladder trigone tissue to disrupt nerves associated with over active bladder.

16. The method of claim 15 , wherein said dissection plane is formed between layers of tissue having a natural separability.

17. The method of claim 15 , wherein said blade comprises a first blade of the cutting device, the cutting device comprising a second blade, the method further comprising using an actuator coupled to said first and second blades to rotate each of said first and second blades back and forth laterally relative to a longitudinal axis of the cutting device in the tissue between the surface of the trigone region of the bladder and a vaginal surface.

18. The method of claim 15 , further comprising repositioning the cutting device at a different location in the bladder trigone and advancing the blade to either

form an additional dissection plane between separated layers of tissue, or

extend the dissection plane between the separated layers of tissue.

19. The method of claim 15 , wherein the blade comprises a first laterally extendable blade, and wherein the cutting tool further includes a second laterally extendable blade, the method comprising moving the first and second blades from a closed configuration to an open configuration after the cutting tool is placed in the bladder trigone, wherein both the first and second blades are advanced through said engaged tissue to form the dissection plane such that the dissection plan is wider than the cutting device.

Assignments (3)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 054089/0804 Recorded Apr 28, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC., ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; GEN-PROBE PRODESSE, INC.
Reel/Frame 075504/0575 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
SECURITY INTEREST Recorded Oct 15, 2020
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 054089/0804 →