IP Library Granted Patent US 9,095,351
Granted Patent B2
US 9,095,351 · App. 14/030,869 · Granted Aug 4, 2015

Apparatus and methods to modulate bladder function

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Quick Facts
Patent No.
US 9,095,351
App. No.
14/030,869
Granted
Aug 4, 2015
Kind
B2
Abstract

Apparatus and methods are provided to concentrate energy delivery in non-superficial target tissue within a trigone region of a human bladder wall to modulate bladder function.

Claims (55)

1. A method to modulate bladder function, comprising:

delivering energy to non-superficial target tissue within a trigone region of a human bladder wall to modulate bladder function by:

positioning a straight longitudinal portion of at least one energy delivery element in the non-superficial target tissue such that longitudinally spaced-apart points along the length of the straight longitudinal portion of the at least one energy delivery element are positioned at generally equal depths from the mucosal surface of the bladder wall, said straight longitudinal portion being longer than said depths; and,

delivering energy to the non-superficial target tissue using the at least one energy delivery element.

2. The method of claim 1 , wherein positioning a straight longitudinal portion of at least one energy delivery element comprises positioning a straight longitudinal portion of each of a plurality of energy delivery elements and wherein delivering energy to the non-superficial target tissue using the at least one energy delivery element comprises delivering energy to the non-superficial target tissue using each of the plurality of energy delivery elements.

3. The method of claim 1 , wherein the delivering energy includes discharging electrical energy.

4. The method of claim 1 further comprising retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact during the step of delivering energy to the non-superficial target tissue.

5. The method of claim 4 , wherein the retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact during the step of delivering energy to the non-superficial tissue includes:

receiving a portion of the mucosal surface at a first surface of an apparatus;

penetrating the mucosal surface of the bladder wall with a first energy delivery element of the at least one energy delivery element, said first energy delivery element separated from said first surface by a distance that defines said depths; and

delivering the energy to the non-superficial target tissue using the first energy delivery element.

6. The method of claim 4 , wherein the at least one energy delivery element comprises a plurality of energy delivery elements and the retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact while delivering energy to the non-superficial tissue includes:

receiving a portion of the mucosal surface at a first surface of an apparatus;

penetrating the mucosal surface of the bladder wall with the plurality of energy delivery elements, said plurality of energy delivery elements separated from said first surface by a distance that defines said depths; and

delivering the energy to the non-superficial target tissue using the plurality of energy delivery elements.

7. The method of claim 1 , including at least partially filling a human bladder with fluid prior to the delivering energy to the non-superficial target tissue within the trigone region of the bladder wall of the human bladder.

8. The method of claim 1 including using an anesthetic injection into the trigone region of a human bladder wall to screen potential patients in a separate procedure prior to delivering energy.

9. The method of claim 1 , including modulating nerve traffic to or from at least a portion of a human bladder using the energy delivery.

10. The method of claim 1 wherein the delivering energy includes modulating at least one of a sense of urinary urge, a sense of urgency, a sense of urinary pressure, urinary incontinence, urinary frequency, nocturia, bladder capacity, or pelvic pain using the delivered energy.

11. The method of claim 1 , wherein the delivering energy includes delivering radio frequency (RF) energy in the non-superficial target tissue.

12. The method of claim 1 , wherein the delivering energy includes delivering at least one of microwave energy, laser energy, cryo energy, ultrasound energy, or electrocautery energy to the non-superficial target tissue.

13. The method of claim 1 wherein positioning a straight longitudinal portion of at least one energy delivery element in the non-superficial target tissue such that longitudinally spaced-apart points along the length of the straight longitudinal portion are positioned at generally equal depths from the mucosal surface of the bladder wall, said straight longitudinal portion being longer than said depths includes receiving a portion of the mucosal surface at a first surface of an apparatus.

14. The method of claim 13 , wherein the receiving the portion of the mucosal surface includes applying suction to grasp and conform the portion of the mucosal surface to at least a portion of the first surface of the apparatus.

15. The method of claim 1 wherein the positioning the straight longitudinal portion of the at least one energy delivery element includes positioning first and second needle electrodes in a bipolar configuration in the non-superficial target tissue, and

wherein the delivering energy includes delivering bipolar energy to the non-superficial target tissue using the first and second needle electrodes.

16. The method of claim 1 , including at least partially denervating the non-superficial target tissue using the energy.

17. The method of claim 1 wherein delivering energy to non-superficial target tissue within a trigone region of a human bladder wall to modulate bladder function comprises introducing a device into the bladder via a urethra.

18. The method of claim 1 wherein positioning a straight longitudinal portion of at least one energy delivery element in the non-superficial target tissue comprises advancing the at least one energy delivery element distally.

19. The method of claim 1 wherein positioning a straight longitudinal portion of at least one energy delivery element in the non-superficial target tissue comprises displacing superficial target tissue adjacent the non-superficial target tissue such that the non-superficial tissue is longitudinally aligned with the straight longitudinal portion of the at least one energy delivery element.

20. A method to modulate bladder function, comprising:

delivering energy to non-superficial target tissue within a trigone region of a human bladder wall at substantially uniform depths below a mucosal surface of the bladder wall to modulate bladder function; positioning at least one energy delivery element substantially parallel to the mucosal surface; and

at least partially denervating the non-superficial target tissue using the delivered energy-delivery,

wherein the delivering energy to the non-superficial target tissue includes retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact by delivering greater energy density to non-superficial target tissues than to tissues superficial to the non-superficial target tissue.

21. The method of claim 20 , including:

receiving a portion of the mucosal surface at a first surface of an apparatus.

22. The method of claim 21 , wherein the delivering energy to non-superficial target tissue includes:

positioning a longitudinal portion of the at least one energy delivery element in the non-superficial target tissue at said depths, said longitudinal portion being longer than said depths; and

delivering energy to the non-superficial target tissue using the energy delivery element.

23. The method of claim 21 , wherein the delivering energy to non-superficial target tissue includes:

positioning the at least one energy delivery element includes positioning a longitudinal portion of a plurality of energy delivery elements in the non-superficial target tissue at said depths, each of said longitudinal portions being longer than said depths; and

delivering energy to the non-superficial target tissue using the plurality of energy delivery elements.

24. The method of claim 21 , wherein the delivering energy to non-superficial target tissue includes delivering radio frequency (RF) energy in the non-superficial target tissue within the trigone region of the bladder wall and ablating the non-superficial target tissue using the energy delivery.

25. The method of claim 21 wherein receiving a portion of the mucosal surface at the first surface of the apparatus comprises: applying suction to grasp and conform a portion of the mucosal surface to at least a portion of a first surface of an apparatus.

26. A method to modulate bladder function, comprising:

applying suction to grasp and conform a portion of a mucosal surface of a trigone region of a human bladder wall to a first surface of an apparatus;

positioning portions of first and second energy delivery elements in non-superficial target tissue such that the portions of the first and second energy delivery elements are substantially parallel to the mucosal surface within the trigone region of the bladder wall; and

delivering energy to the non-superficial target tissue in the trigone region of the bladder wall at substantially uniform depths below the first surface of the apparatus using the portions of the first and second energy delivery elements to modulate bladder function;

wherein the delivering energy to the non-superficial target tissue includes delivering greater energy density to the non-superficial target tissue than to the mucosal surface of the bladder wall superficial to the non-superficial target tissue.

27. The method of claim 26 , wherein the delivering energy to the non-superficial target tissue includes retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact.

28. The method of claim 26 , including:

at least partially denervating the non-superficial target tissue using the delivered energy; and

modulating bladder function using the at least partial denervation, wherein modulating bladder function includes modulating at least one of a sense of urinary urge, a sense of urgency, a sense of urinary pressure, urinary incontinence, urinary frequency, nocturia, bladder capacity, or pelvic pain.

29. The method of claim 26 , wherein the energy includes delivering radio frequency (RF) energy within the non-superficial target tissue in the trigone region of the bladder wall and ablating the non-superficial target tissue using the delivered energy;

wherein the positioning portions of the first and second energy delivery elements includes positioning first and second needle electrodes in the non-superficial target tissue in a bipolar configuration; and

wherein the delivering RF energy within the non-superficial target tissue includes discharging bipolar RF energy to the non-superficial target tissue using the first and second needle electrodes.

Assignments (4)
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 14, 2019
From: HOLOGIC, INC.; CYNOSURE, LLC; CYTYC CORPORATION; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 050719/0701 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 18, 2019
From: AMPHORA MEDICAL, INC.
To: HOLOGIC, INC.,
Reel/Frame 049786/0138 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 18, 2013
From: SACHS, DAN; HLAVKA, EDWIN J.
To: AMPHORA MEDICAL, INC.
Reel/Frame 031235/0646 →