IP Library › Granted Patent US 12,396,777
Granted Patent B2
US 12,396,777 · App. 19/007,206 · Granted Aug 26, 2025

Ablation systems, devices and methods for the treatment of tissue

Inventors: Jay Caplan (Boston, MA); Philip S. Levin (Storrs, CT); Andrew Coats (Somerville, MA); Harith Rajagopalan (Wellesley Hills, MA); Mark A. Manasas (Lexington, MA); J. Christopher Flaherty (Nottingham, NH)
Assignee: Fractyl Health, Inc.
A61B18/04A61B18/06A61M25/1002A61M25/1011A61B2017/00269A61B2018/00011A61B2018/00017A61B2018/0022A61B2018/00494A61B2018/00577A61B2018/00994A61B2018/0212A61B2018/046A61B2018/048A61B18/1492A61B18/24A61M2025/1015A61M2025/105A61N7/022
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Quick Facts
Patent No.
US 12,396,777
App. No.
19/007,206
Granted
Aug 26, 2025
Kind
B2
Abstract

A device for ablating target tissue of a patient with an ablative fluid is provided. An elongate shaft includes a proximal portion and a distal portion, and at least one fluid delivery element is attached to the distal portion. The device can be configured to ablate the duodenal mucosa of a patient while avoiding damage to the duodenal adventitial tissue. Systems and methods of treating target tissue are also provided.

Claims (51)

1. A method of ablating mucosal tissue in a patient's duodenum, the method comprising:

introducing an ablation device into the patient's gastrointestinal (GI) tract, the ablation device comprising:

an elongate shaft;

a proximal radially expandable element attached to the elongate shaft and having a proximal radially expandable element contracted state and a proximal radially expandable element expanded state;

a distal radially expandable element attached to the elongate shaft and having a distal radially expandable element contracted state and a distal radially expandable element expanded state;

identifying an ampulla of Vater in the patient's GI tract;

advancing the ablation device to a first location in the patient's duodenum distal to the ampulla of Vater with the proximal radially expandable element in the proximal radially expandable element contracted state and with the distal radially expandable element in the distal radially expandable element contracted state;

at the first location in the patient's duodenum distal to the ampulla of Vater:

moving the proximal radially expandable element to the proximal radially expandable element expanded state and the distal radially expandable element to the distal radially expandable element expanded state such that each radially expandable element directly contacts a respective circumferential ring of mucosal tissue of a GI wall of the first location and together define a first treatment region of mucosal tissue therebetween; and

causing a first delivery of ablative fluid via a fluid delivery element positioned on the elongate shaft between the proximal and distal radially expandable elements, the ablative fluid directly contacting the mucosal tissue of the first treatment region;

after the first delivery of ablative fluid, moving the ablation device to a second location in the patient's duodenum distal to the ampulla of Vater; and

at the second location in the patient's duodenum distal to the ampulla of Vater:

the proximal and distal radially expandable elements in their respective expanded states together define a second treatment region of mucosal tissue therebetween; and

causing a second delivery of ablative fluid, the ablative fluid directly contacting the mucosal tissue of the second treatment region via the fluid delivery element;

wherein the ablative fluid ablates contacted duodenal mucosal tissue while avoiding damaging duodenal adventitial tissue, and

wherein the method comprises treating at least 50% of an axial length of the patient's duodenum distal to the patient's ampulla of Vater by causing delivery of ablative fluid to additional locations after the first and second locations,

wherein the first location, the second location, and the additional locations are confined to the duodenum.

2. The method of claim 1 , further comprising, after the first delivery of ablative fluid, moving the proximal and distal radially expandable elements to their respective contracted states and then, at the second location, moving the proximal and distal radially expandable elements to their respective expanded states before the second delivery of ablative fluid.

3. The method of claim 1 , wherein at least one of the proximal and the distal radially expandable elements is configured to seal a portion of the GI tract in their respective expanded state.

4. The method of claim 3 , wherein the proximal and distal radially expandable elements in their respective expanded states form an enclosed volume in the GI tract.

5. The method of claim 1 , wherein the ablative fluid comprises steam.

6. The method of claim 1 , wherein introducing the ablation device into the patient's GI tract comprises passing the ablation device through a working channel of an endoscope.

7. The method of claim 6 , wherein advancing the ablation device to the first location in the patient's duodenum comprises distally extending the ablation device beyond a distal end of the working channel of the endoscope.

8. The method of claim 1 , wherein at least one of the proximal and the distal radially expandable elements comprises a radially expandable material resiliently biased in the respective expanded state.

9. The method of claim 1 , wherein the first location and the second location are adjacent or partially overlapping.

10. The method of claim 1 , wherein all of the additional locations are distal the ampulla of Vater.

11. The method of claim 1 , further comprising selecting the first location, the second location, and the additional locations to protect the ampulla of Vater.

12. A method of ablating mucosal tissue in a patient's duodenum, the method comprising:

introducing an ablation device into the patient's gastrointestinal (GI) tract, the ablation device comprising:

an elongate shaft;

a proximal radially expandable element attached to the elongate shaft and having a proximal radially expandable element contracted state and a proximal radially expandable element expanded state;

a distal radially expandable element attached to the elongate shaft and having a distal radially expandable element contracted state and a distal radially expandable element expanded state;

identifying an ampulla of Vater in the patient;

based on identifying the ampulla of Vater in the patient, selecting a plurality of treatment locations in the duodenum at which to treat the mucosal tissue with the ablation device while avoiding damage to the patient's ampulla of Vater, the plurality of treatment locations being confined to the patient's duodenum,

advancing the ablation device to a first location of the plurality of treatment locations in the patient's duodenum with the proximal radially expandable element in the proximal radially expandable element contracted state and with the distal radially expandable element in the distal radially expandable element contracted state;

at the first location in the patient's duodenum:

moving the proximal radially expandable element to the proximal radially expandable element expanded state and the distal radially expandable element to the distal radially expandable element expanded state such that each radially expandable element directly contacts a respective circumferential ring of mucosal tissue of a GI wall of the first location and together define a first treatment region of mucosal tissue therebetween; and

causing a first delivery of ablative fluid via a fluid delivery element positioned on the elongate shaft between the proximal and distal radially expandable elements, the ablative fluid directly contacting the mucosal tissue of the first treatment region;

after the first delivery of ablative fluid, moving the ablation device to a second location of the plurality of treatment locations in the patient's duodenum; and

at the second location in the patient's duodenum:

the proximal and distal radially expandable elements in their respective expanded states together define a second treatment region of mucosal tissue therebetween; and

causing a second delivery of ablative fluid, the ablative fluid directly contacting the mucosal tissue of the second treatment region via the fluid delivery element;

wherein the ablative fluid ablates contacted duodenal mucosal tissue while avoiding damaging duodenal adventitial tissue.

13. The method of claim 12 , further comprising, after the first delivery of ablative fluid, moving the proximal radially expandable element to the proximal radially expandable element contract state and the distal radially expandable element to the distal radially expandable element contracted state and then, at the second location, moving the proximal radially expandable element to the proximal radially expandable element expanded state and the distal radially expandable element to distal radially expandable element expanded state before the second delivery of ablative fluid.

14. The method of claim 12 , wherein at least one of the proximal radially expandable element in the proximal radially expandable element expanded state and the distal radially expandable element in the distal radially expandable element expanded state is configured to seal a portion of the patient's GI tract.

15. The method of claim 14 , wherein in combination the proximal radially expandable element in the proximal radially expandable element expanded state and the distal radially expandable element in the distal radially expandable element expanded state form an enclosed volume in the patient's GI tract.

16. The method of claim 12 , wherein the ablative fluid comprises steam.

17. The method of claim 12 , wherein introducing the ablation device into the patient's GI tract comprises passing the ablation device through a working channel of an endoscope.

18. The method of claim 17 , wherein advancing the ablation device to the first location in the patient's duodenum comprises distally extending the ablation device beyond a distal end of the working channel of the endoscope.

19. The method of claim 12 , wherein at least one of the proximal radially expandable element and the distal radially expandable element comprises a radially expandable material resiliently biased in the respective expanded state.

20. The method of claim 12 , wherein the method comprises treating at least 50% of an axial length of the patient's duodenum.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 9, 2025
From: CAPLAN, JAY; LEVIN, PHILIP S.; COATS, ANDREW; RAJAGOPALAN, HARITH; MANASAS, MARK A.; FLAHERTY, J. CHRISTOPHER
To: FRACTYL LABORATORIES, INC.
Reel/Frame 071646/0849 →
CHANGE OF NAME Recorded Jul 9, 2025
From: FRACTYL LABORATORIES, INC.
To: FRACTYL HEALTH, INC.
Reel/Frame 071874/0559 →
Continuity (6)
Continuation 18786113 · Jul 26, 2024
Continuation 17192671 · Mar 4, 2021
Continuation 14609334 · Jan 29, 2015
Continuation PCTUS2013054219 · Aug 8, 2013
Provisional Application 61681502 · Aug 9, 2012
Related Publication 20250127551A1 · Apr 24, 2025
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