APPARATUS AND METHODS TO MODULATE BLADDER FUNCTION

1 . An energy delivery apparatus configured to modulate bladder function, comprising:

an elongated shaft sized and shaped to be inserted into a human urethra;

a distal region coupled to the elongated shaft, the distal region sized and shaped to be inserted into a human bladder through the urethra, the distal region having a first surface defining a first plane, the first surface configured to receive a portion of a mucosal surface of a trigone region of a bladder wall of the bladder; and

first and second energy delivery elements defining a second plane, wherein the second plane is a uniform distance spaced apart from the first plane, wherein the first and second energy delivery elements are configured to deliver energy to non-superficial target tissue within a trigone region of a bladder wall to modulate bladder function,

wherein the first surface is laterally accessible on at least two sides.

2 . The apparatus of claim 1 , wherein the first surface includes a suction port, and wherein the first surface is configured to receive the portion of the mucosal surface of the trigone region of the bladder wall using the suction port.

3 . The apparatus of claim 1 , wherein the first and second energy delivery elements are extendable in the second plane and are configured to deliver energy to the non-superficial target tissue within the trigone region of the bladder wall while retaining a mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact.

4 . The apparatus of claim 1 , wherein locations along the first and second energy delivery elements define the second plane.

5 . The apparatus of claim 1 , wherein the first surface is coupled on one side to the elongated shaft and is laterally accessible about the remainder of the first surface to receive the mucosal surface of the trigone region of the bladder wall.

6 . The apparatus of claim 1 , wherein the first surface has a length extending longitudinally from the elongated shaft, wherein the length of the first surface is greater than a width of the first surface by a factor of at least 3.

7 . The apparatus of claim 1 , wherein the first and second energy delivery elements include longitudinal portions configured to be disposed in the non-superficial target tissue at the uniform distance spaced apart from the first surface of the distal region,

wherein the longitudinal portions of the first and second energy delivery elements define the second plane, and

wherein a length of the longitudinal portions of the first and second energy delivery elements is greater than the uniform distance spaced apart from the first surface of the distal region by a factor of at least 3.

8 . The apparatus of claim 1 , wherein the first and second energy delivery elements are configured to deliver energy to non-superficial target tissue within the trigone region of a bladder wall to modulate bladder 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.

9 . The apparatus of claim 1 , wherein the first and second energy delivery elements are configured to deliver radio frequency (RF) energy to the non-superficial target tissue within the trigone region of the bladder wall to modulate bladder function.

10 . A method to modulate bladder function, comprising:

inserting an elongated shaft into a human urethra, the elongated shaft sized and shaped for insertion into the urethra;

inserting a distal region coupled to the elongated shaft into a human bladder through the urethra, the distal region sized and shaped for insertion into the bladder through the urethra, the distal region having a first surface defining a first plane, wherein the first surface is laterally accessible on at least two sides;

receiving a portion of a mucosal surface of a trigone region of a bladder wall of the bladder at the first surface of the distal region;

locating first and second energy delivery elements in a second plane, wherein the second plane is a uniform distance spaced apart from the first plane; and

delivering energy to non-superficial target tissue within a trigone region of a bladder wall to modulate bladder function using the first and second energy delivery elements.

11 . The method of claim 10 , wherein the delivering energy to the non-superficial target tissue includes concentrating energy delivery in the non-superficial target tissue within the trigone region of the bladder wall to modulate bladder function while retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact, and

wherein the retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact includes:

receiving the portion of the mucosal surface at the first surface of the distal region;

penetrating the mucosal surface of the bladder wall with the first and second energy delivery elements;

positioning portions of the first and second energy delivery elements in the non-superficial target tissue in the second plane; and

delivering energy to the non-superficial target tissue using the first and second energy delivery elements.

12 . The method of claim 10 , including at least partially filling the bladder with fluid before delivering energy to the non-superficial target tissue.

13 . The method of claim 10 , wherein the delivering energy to the non-superficial target tissue includes delivering bipolar energy to the non-superficial target tissue using the first and second energy delivery elements, and

wherein the method includes at least partially denervating the non-superficial target tissue using the delivered bipolar energy.

14 . The method of claim 10 , wherein the receiving the portion of the mucosal surface includes using a suction port at the first surface to grasp and conform the portion of the mucosal surface to at least a portion of the first surface of the apparatus.

15 . An energy delivery apparatus configured to modulate bladder function, comprising:

an elongated shaft sized and shaped to be inserted into a human urethra;

a distal region coupled to the elongated shaft, the distal region sized and shaped to be inserted into a human bladder through the urethra; and

an energy delivery element configured to deliver energy to non-superficial target tissue within a trigone region of a bladder wall of the bladder to modulate bladder function,

wherein the energy delivery element has a treatment length greater than a width of the distal region by a factor of at least 3.

16 . The apparatus of claim 15 , wherein the energy delivery element has a treatment length greater than the width of the distal region by a factor of at least 4.

17 . The apparatus of claim 15 , wherein the energy delivery element is configured to deliver energy to non-superficial target tissue at a uniform distance spaced apart from the mucosal surface of the bladder to modulate bladder function.

18 . The apparatus of claim 15 , wherein the energy delivery element includes first and second energy delivery elements configured to deliver energy to non-superficial target tissue.

19 . The apparatus of claim 15 , wherein the distal region includes a first surface configured to receive a portion of the mucosal surface of the trigone region of the bladder wall,

wherein the first surface defines a first plane,

wherein the energy delivery element is a uniform distance spaced apart from the first plane,

wherein a length of the distal region is greater than the uniform distance spaced apart from the first plane by a factor of at least 3.

20 . The apparatus of claim 15 , wherein the distal region includes a first surface configured to receive a portion of the mucosal surface of the trigone region of the bladder wall,

wherein the energy delivery element includes a longitudinal portion configured to be disposed in the non-superficial target tissue at a uniform distance spaced apart from the first surface of the distal region to deliver energy to the non-superficial target tissue while retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact.

21 . The apparatus of claim 20 , wherein the first surface includes a suction port configured to grasp and conform the portion of the mucosal surface to at least a portion of the first surface.

22 . An energy delivery apparatus configured to modulate bladder function, comprising:

an elongated shaft sized and shaped to be inserted into a human urethra;

a distal region coupled to the elongated shaft, the distal region sized and shaped to be inserted into a human bladder through the urethra; and

an energy delivery element configured to deliver energy to non-superficial target tissue within a trigone region of a bladder wall of the bladder to modulate bladder function,

wherein the distal region includes a first surface configured to receive a portion of a mucosal surface of the trigone region of the bladder wall,

wherein the energy delivery element includes longitudinally distributed locations configured to be disposed in the non-superficial target tissue at a uniform distance spaced apart from the first surface of the distal region, and

wherein a length spanned by the longitudinally distributed locations is greater than the uniform distance spaced apart from the first surface of the distal region by a factor of at least 3.

23 . The apparatus of claim 22 , wherein the energy delivery element includes a longitudinal portion,

wherein the longitudinally distributed locations of the energy delivery element are disposed along the longitudinal portion of the energy delivery element,

wherein the longitudinal portion is configured to be disposed in the non-superficial target tissue at the uniform distance spaced apart from the first surface of the distal region, and

wherein a length of the longitudinal portion is greater than the uniform distance spaced apart from the first surface of the distal region by a factor of at least 3.

24 . The apparatus of claim 23 , wherein the energy delivery element includes first and second energy delivery elements having longitudinal portions configured to deliver energy to the non-superficial target tissue.

25 . The apparatus of claim 22 , wherein the length spanned by the longitudinally distributed locations is greater than the uniform distance spaced apart from the first surface of the distal region by a factor of 3-6.

26 . The apparatus of claim 22 , wherein the length spanned by the longitudinally distributed locations is greater than the uniform distance spaced apart from the first surface of the distal region by a factor of at least 4.

27 . The apparatus of claim 22 , wherein length spanned by the longitudinally distributed locations is greater than a width of the first surface by a factor of at least 3.

28 . The apparatus of claim 22 , wherein the energy delivery element includes a plurality of energy delivery elements corresponding to respective longitudinally distributed location, each of the plurality of energy delivery elements configured to be positioned in the non-superficial target tissue from the first surface.

29 . The apparatus of claim 22 , wherein the first surface includes a suction port configured to grasp and conform the portion of the mucosal surface to at least a portion of the first surface.

30 . The apparatus of claim 22 , wherein the energy delivery element is configured to deliver energy to the non-superficial target tissue within the trigone region of the bladder wall to modulate bladder function while retaining a mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact.