Methods and devices for treating pelvic conditions
A device and method that provides a minimally-invasive approach to performing treatments on soft tissue, such as that found in the bladder. The device is useful for manipulating tissue such that treatment tools can be inserted into the tissue at a controlled depth.
1. An energy delivery apparatus configured to modulate bladder function, the apparatus comprising:
an elongate shaft having a distal portion sized to be inserted through a human urethra and into a bladder, the shaft comprising first and second electrode lumens extending along a longitudinal axis of the shaft;
a suction head coupled to a distal end of the shaft and comprising a first surface defining a first plane and one or more suction apertures;
a first electrode positioned in the first electrode lumen, the first electrode comprising an intermediate portion and a distal portion extending distally from the intermediate portion; and
a second electrode positioned in the second electrode lumen, the second electrode comprising an intermediate portion and a distal portion extending distally from the intermediate portion,
wherein the first and second electrodes are longitudinally movable relative to the respective first and second electrode lumens between:
(i) a retracted configuration, in which the intermediate and distal portions of the first and second electrodes are fully contained within the respective first and second electrode lumens, and
(ii) a deployed configuration, in which the intermediate and distal portions of the first and second electrodes are fully extended out respective distal end openings of the first and second electrode lumens, and
wherein, when the first and second electrodes are in the deployed configuration, the intermediate portion of each of the first and second electrodes has a curved configuration, and the distal portion of each of the first and second electrodes has a straight configuration and extends within a second plane that is parallel with the first plane.
2. The apparatus of claim 1 , wherein, when the first and second electrodes are in the retracted configuration, the intermediate portion of each of the first and second electrodes is constrained in a linear configuration within the respective first and second electrode lumens.
3. The apparatus of claim 1 , wherein the first and second electrodes each comprises an elastic shape-memory material that facilitates the intermediate portions to elastically reconfigure from linear to curved when the first and second energy delivery electrodes reconfigure from the retracted configuration to the deployed configuration.
4. The apparatus of claim 1 , further comprising an electrically insulative material covering on the respective intermediate portions of the first and second electrodes.
5. The apparatus of claim 1 , wherein the suction head further comprises an angled face adjacent to and proximal of the first surface, the angled face defining at least one suction aperture, and wherein an obtuse angle is defined between the angled face and the first surface.
6. The apparatus of claim 5 , wherein the angled face is disposed between the first surface and the distal end openings of the first and second electrode lumens.
7. The apparatus of claim 1 , wherein, when the distal portion of the shaft is positioned in a bladder such that the first surface of the suction head is in contact with a mucosal tissue surface of a trigone region of the bladder wall, and the first and second electrodes are moved from the retracted configuration to the deployed configuration, the first and second electrodes are configured to deliver energy along the second plane to non-superficial target tissue within the trigone region of the bladder wall to thereby modulate bladder function while retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact.
8. The apparatus of claim 1 , wherein the shaft comprises a scope channel configured to receive a visualization device for providing visual confirmation of placement of the suction head at a targeted tissue surface.
9. The apparatus of claim 8 , wherein the shaft comprises one or more sealed suction channels in fluid communication with the one or more suction apertures in the first surface of the suction head.
10. The apparatus of claim 1 , further comprising a handle assembly attached to a proximal end portion of the shaft, the handle assembly comprising a first actuator operatively coupled to the first and second electrodes and configured to move the first and second electrodes between the retracted configuration and the deployed configuration.
11. The apparatus of claim 10 , the handle assembly further comprising a second actuator configured to selectively electrically couple the first and second electrodes with an electrical energy source.
12. The apparatus of claim 11 , further comprising
a first interlock that prevents the first and second electrodes from being moved from the retracted configuration to the deployed configuration unless a pressure indicates that a mucosal tissue surface is being retained by the one or more suction apertures of the first surface, and
a second interlock that prevents the first and second electrodes from being coupled to the electrical energy source unless the first and second electrodes are in the deployed configuration.
13. An energy delivery apparatus configured to modulate bladder function, the apparatus comprising:
an elongate shaft having a distal portion sized to be inserted through a human urethra and into a bladder, the shaft comprising first and second electrode lumens extending along a longitudinal axis of the shaft;
a suction head coupled to a distal end of the shaft and comprising a first surface having one or more suction apertures;
a first electrode positioned in the first electrode lumen, the first electrode comprising an intermediate portion and a distal portion extending distally from the intermediate portion; and
a second electrode positioned in the second electrode lumen, the second electrode comprising an intermediate portion and a distal portion extending distally from the intermediate portion,
wherein the first and second electrodes are longitudinally movable relative to the respective first and second electrode lumens between:
(i) a retracted configuration, in which the intermediate and distal portions of the first and second electrodes are fully contained within the respective first and second electrode lumens, and
(ii) a deployed configuration, in which the intermediate and distal portions of the first and second electrodes are fully extended out respective distal end openings of the first and second electrode lumens,
wherein, when the first and second electrodes are in the deployed configuration, the intermediate portion of each of the first and second electrodes has a curved configuration, and the distal portion of each of the first and second electrodes has a straight configuration, and
wherein a cross-sectional profile of a distal end portion of the device expands when the first and second electrodes transition from the retracted configuration to the deployed configuration.
14. The apparatus of claim 13 , wherein the first and second electrodes each comprises an elastic shape-memory material that facilitates the intermediate portions to elastically reconfigure from linear to curved when the first and second energy delivery electrodes reconfigure from the retracted configuration to the deployed configuration.
15. The apparatus of claim 13 , further comprising an electrically insulative material covering on the respective intermediate portions of the first and second electrodes.
16. The apparatus of claim 13 , wherein the suction head further comprises an angled face adjacent to and proximal of the first surface, the angled face defining at least one suction aperture, and wherein an obtuse angle is defined between the angled face and the first surface.
17. The apparatus of claim 13 , wherein, when the distal portion of the shaft is positioned in a bladder such that the first surface of the suction head is in contact with a mucosal tissue surface of a trigone region of the bladder wall, and the first and second electrodes are moved from the retracted configuration to the deployed configuration, the first and second electrodes are configured to deliver energy along the second plane to non-superficial target tissue within the trigone region of the bladder wall to thereby modulate bladder function while retaining the mucosal surface of the bladder wall superficial to the non-superficial target tissue substantially intact.
18. The apparatus of claim 13 , wherein the shaft comprises
a scope channel configured to receive a visualization device for providing visual confirmation of placement of the suction head at a targeted tissue surface, and
one or more sealed suction channels in fluid communication with the one or more suction apertures in the first surface of the suction head.
19. The apparatus of claim 13 , further comprising a handle assembly attached to a proximal end portion of the shaft, the handle assembly comprising
a first actuator operatively coupled to the first and second electrodes and configured to move the first and second electrodes between the retracted configuration and the deployed configuration, and
a second actuator configured to selectively electrically couple the first and second electrodes with an electrical energy source.
20. The apparatus of claim 19 , further comprising
a first interlock that prevents the first and second electrodes from being moved from the retracted configuration to the deployed configuration unless a pressure indicates that a mucosal tissue surface is being retained by the one or more suction apertures of the first surface, and
a second interlock that prevents the first and second electrodes from being coupled to the electrical energy source unless the first and second electrodes are in the deployed configuration.