Granted Patent B2

US 12,201,342 · App. 17/864,855 · Granted Jan 21, 2025

Inventors: Philip S. Levin (Storrs, CT); Jay Caplan (Belmont, MA); Harith Rajagopalan (Wellesley Hills, MA); Mark A. Manasas (Lexington, MA); Andrew Coats (Somerville, MA); J. Christopher Flaherty (Nottingham, NH)

Assignee: Fractyl Health, Inc.

A61B18/082A61B18/04A61B2018/00023A61B2018/00214A61B2018/0022A61B2018/0025A61B2018/00482A61B2018/00494A61B2018/00577A61B2018/00648A61B2018/00744A61B2018/044A61B2018/046A61B18/1492A61M25/04A61M2025/1013F04C2270/0421

Abstract

Claims (23)

1. A method of treating target tissue, the method comprising:

(1) providing a system comprising an energy delivery unit and an ablation device, wherein the ablation device comprises an elongate tube with a proximal portion, a distal portion, and at least one lumen extending from the proximal portion to the distal portion, and wherein the ablation device further comprises an expandable treatment element mounted to the elongate tube distal portion and in fluid communication with the at least one lumen;

(2) delivering a first thermal dose to a first location of target tissue by delivering energy from the expandable treatment element to the target tissue by (a) delivering a first volume of a first heated fluid via the energy delivery unit to the expandable treatment element to ablate the target tissue, (b) subsequently delivering a first volume of a first cooling fluid via the energy delivery unit to the expandable treatment element to dilute the first volume of the first heated fluid, thereby generating a mixed fluid to cool the target tissue; and

subsequently applying a negative pressure to remove the mixed fluid from the expandable treatment element.

2. The method according to claim 1 , wherein the first cooling fluid is delivered to the expandable treatment element at a temperature at least 10° C. below the temperature of the first heated fluid.

3. The method according to claim 1 , further comprising delivering a second volume of the first cooling fluid to the expandable treatment element to cool the target tissue prior to delivering the first heated fluid to the expandable treatment element.

4. The method according to claim 1 , further comprising moving the expandable treatment element to a second location of target tissue and delivering a second thermal dose to the second location.

5. The method according to claim 4 , wherein the second location is proximal to the first location.

6. The method according to claim 4 , wherein the second location is distal to the first location.

7. The method according to claim 4 , wherein delivering the second thermal dose comprises (a) delivering a second volume of the first heated fluid to the expandable treatment element to ablate the second location of target tissue, and (b) subsequently delivering a second volume of the first cooling fluid to the expandable treatment element to cool the second location target tissue.

8. The method according to claim 7 , further comprising applying a negative pressure via the energy delivery unit subsequently after delivering the second volume of the first cooling fluid to the expandable treatment element to remove the second volume of the first heated fluid and the second volume of the first cooling fluid from the expandable treatment element.

9. The method according to claim 7 , wherein the system further comprises a controller constructed and arranged to modify delivery of the first thermal dose and/or the second thermal dose.

10. The method according to claim 9 , wherein the target tissue comprises a tissue lining of an interior of a hollow body organ and the controller is configured to modulate the temperature of the heated fluid to deliver the first thermal dose and/or the second thermal dose to ablate the tissue lining of the interior of the hollow body organ while avoiding other damage to the hollow body organ.

11. The method according to claim 9 , wherein the controller is configured to modulate the first thermal dose and/or the second thermal dose to ablate the target tissue while avoiding damage to non-target tissue.

12. The method according to claim 1 , wherein the first cooling fluid comprises a temperature less than or equal to 10° C.

13. The method according to claim 1 , wherein the energy delivery unit comprises at least one fluid pump constructed and arranged to deliver both the first cooling fluid and the first heated fluid to the expandable treatment element.

14. The method according to claim 13 , wherein the at least one fluid pump is constructed and arranged to deliver the first cooling fluid and/or the first heated fluid at a flow rate of at least 50 ml/min.

15. The method according to claim 13 , wherein the at least one fluid pump of the energy delivery unit is configured to apply the negative pressure.

16. The method according to claim 2 , wherein the expandable treatment element further comprises a fluid mixing assembly constructed and arranged to cause fluid mixing within the treatment element.

17. The method according to claim 2 , wherein the delivery of the first heated fluid comprises circulating heated fluid through the expandable treatment element.

18. The method according to claim 17 , wherein the first heated fluid is maintained at a relatively constant temperature while in the expandable treatment element.

19. The method according to claim 1 , wherein the system is constructed and arranged to inflate the expandable treatment element within 10 seconds.

20. The method according to claim 1 , wherein the first heated fluid is maintained at a temperature between 65° C. and 99° C.

Assignments (3)

Continuity (5)

References Cited (379)