Catheter Devices for Defunctionalization of a Gallbladder, and Systems and Methods Thereof

20230090573

17/865469

July 15, 2022

Provided herein is an apparatus having a first tubular body, a second tubular body disposable within the first tubular body, a first plurality of fenestrations in fluid communication with a gallbladder lumen, and an expandable body disposed around the first plurality of fenestrations. The first plurality of fenestrations is configured to deliver a phase changing ablation medium by spraying the phase changing ablation medium in a spatially diffuse pattern into the space defined by the expandable body between the first plurality of fenestrations and the wall of the gallbladder. The first tubular body and the second tubular body define an annular flow path. A pressure sensor measures intraluminal pressure of the gallbladder. A control unit is coupled to the pressure sensor.

1. An apparatus, comprising: a first tubular body having a distal end configured to be inserted through an opening in a wall of a gallbladder and to be disposed in a gallbladder lumen; a second tubular body disposable within the first tubular body, the second tubular body having a proximal end, a distal end, and a lumen extending therebetween, the distal end of the second tubular body configured to extend distally from the first tubular body and to be disposed within the gallbladder lumen; a first plurality of fenestrations in fluid communication with the lumen, the first plurality of fenestrations distributed along a distal end portion of the second tubular body and spanning a full circumference of the second tubular body, the lumen configured to convey a phase changing ablation medium to the first plurality of fenestrations; an expandable body disposed around the first plurality of fenestrations, the expandable body configured to transition into an expanded state within the gallbladder lumen, the expandable body including a second plurality of fenestrations in fluid communication with the first plurality of fenestrations, the expandable body in the expanded state configured to define a space between the first plurality of fenestrations and the wall of the gallbladder such that the first plurality of fenestrations are centrally located within the gallbladder lumen, the first plurality of fenestrations configured to deliver the phase changing ablation medium by spraying the phase changing ablation medium in a spatially diffuse pattern into the space defined by the expandable body between the first plurality of fenestrations and the wall of the gallbladder, and the second plurality of fenestrations defining a plurality of ablation medium flow paths out of the expandable body to allow the phase changing ablation medium to contact and ablate the wall of the gallbladder, the first tubular body and the second tubular body defining an annular flow path therebetween, the annular flow path configured to evacuate the phase changing ablation medium from the gallbladder lumen; a pressure sensor configured to measure an intraluminal pressure of the gallbladder; and a control unit operatively coupled to the pressure sensor, the control unit configured to control the delivery or the evacuation of the phase changing ablation medium based on the intraluminal pressure of the gallbladder to maintain the intraluminal pressure of the gallbladder within a predefined range.

2. The apparatus of claim 1, wherein the control unit is configured to maintain the intraluminal pressure within a predefined range that allows for insufflation of the gallbladder lumen without exceeding a threshold pressure.

3. The apparatus of claim 1, wherein the predefined range is between about 5 mmHg and about 200 mmHg.

4. The apparatus of claim 1, wherein the phase changing ablation medium is configured to transition from a liquid to a gas upon exiting from the first plurality of fenestrations.

5. The apparatus of claim 1, wherein the phase changing ablation medium is a cryogenic ablation medium.

6. The apparatus of claim 1, wherein the first tubular body and the second tubular body define a lumen for receiving a guidewire.

7. The apparatus of claim 1, further comprising a cystic duct occluder disposed at the distal end of the second tubular body, the cystic duct occluder configured to occlude a cystic duct when the distal end portion of the second tubular body is disposed within the gallbladder lumen.

8. The apparatus of claim 1, wherein the expandable body is a first expandable body, the apparatus further comprising a second expandable body disposed around the distal end of the first tubular body, the second expandable body configured to prevent dislodgement of the apparatus once deployed within the gallbladder lumen.

9. The apparatus of claim 1, wherein the second plurality of fenestrations span a circumference of the expandable body and an axial length of the expandable body.

10. The apparatus of claim 1, further comprising a valve, the control unit configured to control the delivery or the evacuation of the phase changing ablation medium by controlling the valve.

11. The apparatus of claim 1, wherein the pressure sensor is disposed at a proximal end of the apparatus, and the first tubular body is configured to communicate the intraluminal pressure of the gallbladder to the pressure sensor.

12. The apparatus of claim 1, wherein one or more fenestrations from the first plurality of fenestrations are directionally biased to increase distribution of the phase changing ablation medium across the gallbladder lumen.

13. An apparatus, comprising: a first tubular body having a distal end configured to be inserted through an opening in a wall of a gallbladder and to be disposed in a gallbladder lumen; a second tubular body disposable within the first tubular body, the second tubular body having a proximal end, a distal end, and a lumen extending therebetween, the distal end of the second tubular body configured to extend distally from the first tubular body and to be disposed within the gallbladder lumen; a first plurality of fenestrations in fluid communication with the lumen, the first plurality of fenestrations distributed along a distal end portion of the second tubular body and spanning a full circumference of the second tubular body, the lumen configured to convey a phase changing ablation medium to the first plurality of fenestrations; a first expandable body disposed around the first plurality of fenestrations, the first expandable body configured to transition into an expanded state within the gallbladder lumen, the first expandable body including a second plurality of fenestrations in fluid communication with the first plurality of fenestrations, the first expandable body in the expanded state configured to define a space between the first plurality of fenestrations and the wall of the gallbladder, the first plurality of fenestrations configured to configured to deliver the phase changing ablation medium by spraying the phase changing ablation medium in a spatially diffuse pattern into the space defined by the first expandable body between the first plurality of fenestrations and the wall of the gallbladder, and the second plurality of fenestrations defining a plurality of ablation medium flow paths out of the expandable body to allow the phase changing ablation medium to contact and ablate the wall of the gallbladder, the first tubular body and the second tubular body defining an annular flow path therebetween, the annular flow path configured to evacuate the phase changing ablation medium from the gallbladder lumen; and a second expandable body disposed around the distal end of the first tubular body, the second expandable body in the expanded state configured to prevent dislodgement of the apparatus once deployed in the gallbladder lumen.

14. The apparatus of claim 13, wherein the second tubular body is configured to move relative to the first tubular body to control a location of the delivery of the phase changing ablation medium via the first plurality of fenestrations relative to a location of the evacuation of the phase changing ablation medium via the annular flow path.

15. The apparatus of claim 13, wherein the phase changing ablation medium is configured to transition from a liquid to a gas upon exiting from the first plurality of fenestrations.

16. The apparatus of claim 12, wherein the first tubular body and the second tubular body define a lumen for receiving a guidewire.

17. The apparatus of claim 13, further comprising a cystic duct occluder disposed at the distal end of the second tubular body, the cystic duct occluder configured to occlude a cystic duct when the distal end portion of the second tubular body is disposed within the gallbladder lumen.

18. The apparatus of claim 13, wherein the second expandable body is configured to create a seal between the first tubular body and the wall of the gallbladder near the opening.

19. The apparatus of claim 13, wherein the second plurality of fenestrations span a circumference of the expandable body and an axial length of the expandable body.

20. A system, comprising: an ablation medium supply configured to contain a phase changing ablation medium; an ablation catheter including: a first tubular body having a distal end configured to be inserted through an opening in a wall of a gallbladder and to be disposed in a gallbladder lumen; a second tubular body disposable within the first tubular body, the second tubular body having a proximal end, a distal end, and a lumen extending therebetween, the distal end of the second tubular body configured to extend distally from the first tubular body and to be disposed within the gallbladder lumen; a first plurality of fenestrations in fluid communication with the lumen, the first plurality of fenestrations distributed along a distal end portion of the second tubular body, the lumen configured to convey the phase changing ablation medium from the ablation medium supply to the first plurality of fenestrations; and an expandable body disposed around the first plurality of fenestrations, the expandable body configured to transition into an expanded state within the gallbladder lumen, the expandable body including a second plurality of fenestrations in fluid communication with the first plurality of fenestrations, the expandable body in the expanded state configured to define a space between the first plurality of fenestrations and the wall of the gallbladder, the first plurality of fenestrations configured to deliver the phase changing ablation medium by spraying the phase changing ablation medium in a spatially diffuse pattern into the space defined by the expandable body between the first plurality of fenestrations and the wall of the gallbladder, and the second plurality of fenestrations defining a plurality of ablation medium flow paths out of the expandable body to allow the phase changing ablation medium to contact and ablate the wall of the gallbladder, the first tubular body and the second tubular body defining an annular flow path therebetween, the annular flow path configured to evacuate the phase changing ablation medium from the gallbladder lumen; a pressure sensor configured to measure an intraluminal pressure of the gallbladder; and a control unit operatively coupled to the pressure sensor and to the ablation device, the control unit configured to control the delivery or the evacuation of the phase changing ablation medium based on the intraluminal pressure of the gallbladder to maintain the intraluminal pressure of the gallbladder within a predefined range.

21. The system of claim 20, wherein the control unit is configured to maintain the intraluminal pressure within a predefined range that allows for insufflation of the gallbladder lumen without exceeding a threshold pressure.

22. The system of claim 20, wherein the predefined range is between about 5 mmHg and about 200 mmHg.

23. The system of claim 20, wherein the phase changing ablation medium is configured to transition from a liquid to a gas upon exiting from the first plurality of fenestrations.

24. The system of claim 20, wherein the phase changing ablation medium is a cryogenic ablation medium.

25. A method, comprising: deploying an expandable body disposed around a distal end portion of an inner tubular body of an ablation catheter disposed within a gallbladder such that the expandable body defines a space between the distal end portion of the inner tubular body and a wall of the gallbladder, the inner tubular body slidably disposed within a lumen of an outer tubular body of the ablation device with the distal end portion of the inner tubular body extending distally from a distal end of the outer tubular body; conveying, via a lumen of the inner tubular body, a phase changing ablation medium in a liquid state to the distal end portion of the inner tubular body; delivering, via a first plurality of fenestrations distributed along the distal end portion of the inner tubular body and spanning a full circumference of the inner tubular body, the phase changing ablation medium in a spatially diffuse pattern into the space defined by the expandable body, the phase changing ablation medium transitioning from the liquid state into a gas state during the delivery; in response to the delivering, insufflating the gallbladder and ablating the gallbladder; evacuating, via the lumen of the outer tubular body, at least a portion of the phase changing ablation medium from the gallbladder after the delivering of the phase changing ablation medium; monitoring, via a pressure sensor, an intraluminal pressure of the gallbladder; and controlling, via a control unit, the delivering or the evacuating of the phase changing ablation medium based on the intraluminal pressure.

26. The method of claim 25, further comprising: measuring, via a temperature sensor, an intraluminal temperature of the gallbladder lumen; and controlling, via the control unit, at least one of the delivering or the evacuating of the phase changing ablation medium based on the intraluminal temperature.

27. The method of claim 25, further comprising: navigating the ablation catheter into the gallbladder by placing the ablation catheter over a guidewire, the ablation catheter further including a lumen for receiving the guidewire.

28. The method of claim 25, wherein the expandable body is a first expandable body, the method further comprising: deploying a second expandable body disposed around the distal end of the outer tubular body to retain the ablation catheter within the gallbladder, the delivering the phase changing ablation medium being after the deployment of the second expandable body.

29. The method of claim 25, wherein the controlling the at least one of the delivering or the evacuating of the phase changing ablation medium includes activating a vacuum source operably coupled to the lumen of the outer tubular body to increase an evacuation rate of the phase changing ablation medium through the lumen of the outer tubular body.

30. The method of claim 25, wherein the controlling the at least one of the delivering or the evacuating of the phase changing ablation medium includes stopping a supply flow rate of the phase changing ablation medium.

61; 61; 61

edspap.20230090573