Granted Patent B2

US 12,364,554 · App. 17/863,016 · Granted Jul 22, 2025

Inventors: Jay Caplan (Boston, MA); Harith Rajagopalan (Wellesley Hills, MA); Andrew Hollett (Somerville, MA); R. Maxwell Flaherty (Topsfield, MA); J. Christopher Flaherty (Nottingham, NH); Jeffrey Lesica (Holliston, MA)

Assignee: Fractyl Health, Inc.

A61B34/32A61B34/20A61B34/37A61B2017/00199A61B2018/00494A61B2018/00577A61B2034/2048A61B2034/2061A61B2034/301A61B2034/303A61B2090/064

Abstract

Claims (33)

1. A system for performing a medical procedure in the intestine of a patient comprising:

an elongate device comprising a proximal portion, a middle portion, and a distal portion;

the elongate device further comprising a functional assembly positioned on the distal portion, wherein the functional assembly is configured to treat target tissue of the duodenum of the patient;

a visualization device configured to image the duodenum of the patient, and

a console comprising a human interface device, an image processor, and a controller;

wherein the image processor is configured to receive image information from the visualization device and automatically determine a location of the patient's papilla and provide an indication of the location for use in navigating the functional assembly within the duodenum;

wherein the console is configured to robotically manipulate one, two, or more of:

the elongate device proximal portion;

the elongate device middle portion;

the elongate device distal portion; and/or

the elongate device functional assembly,

wherein the functional assembly comprises an assembly configured to expand and contract, and

wherein the functional assembly is configured to ablate and/or remove the target tissue of the patient.

2. The system according to claim 1 , wherein the console is configured to robotically manipulate at least the elongate device distal portion.

3. The system according to claim 2 , wherein the console is further configured to robotically manipulate the elongate device functional assembly.

4. The system according to claim 1 , wherein the console is configured to perform the robotic manipulation based on an input to the human interface device.

5. The system according to claim 4 , wherein the robotic manipulation comprises a ratiometric movement of the functional assembly based on the input to the human interface device.

6. The system according to claim 1 , further comprising a shape sensing assembly, wherein the robotic manipulation is performed based on information produced by the shape sensing assembly.

7. The system according to claim 1 , further comprising a force sensing assembly, wherein the robotic manipulation is performed based on information produced by the force sensing assembly.

8. The system according to claim 1 , further comprising a position sensing assembly, wherein the robotic manipulation is performed based on information produced by the position sensing assembly.

9. The system according to claim 8 , wherein the position sensing assembly is configured to provide location information related to the position of the elongate device distal portion relative to the patient's anatomy.

10. The system according to claim 9 , wherein the location information is related to the position of the functional assembly relative to the patient's anatomy.

11. The system according to claim 8 , wherein the position sensing assembly further comprises at least one position sensor.

12. The system according to claim 11 , wherein the position sensing assembly comprises a component selected from the group consisting of: a visualizable element, such as a radiopaque element and/or an ultrasonically reflective element; an electromagnetic element; a fiber optic sensor; a fiber Bragg grating sensor; accelerometer; and combinations thereof.

13. The system according to claim 11 , wherein the at least one position sensor comprises an accelerometer.

14. The system according to claim 1 , wherein the elongate device distal portion is more flexible than the proximal portion and the middle portion.

15. The system according to claim 14 , wherein the elongate device comprises a stiffening member positioned within the proximal portion and the middle portion.

16. The system according to claim 15 , wherein the elongate device comprises a lumen and wherein the stiffening member is configured to be advanced through the lumen.

17. The system according to claim 15 , wherein the stiffening member comprises a distal portion that is steerable.

18. The system according to claim 15 , further comprises a shape sensing assembly configured to produce shape information related to a current geometry of the stiffening member and/or elongate device.

19. The system according to claim 18 , wherein the shape sensing assembly comprises an element selected from the group consisting of: a visualizable element, such as a radiopaque element and/or an ultrasonically reflective element; an electromagnetic element; a fiber optic; a fiber Bragg grating sensor; accelerometer; and combinations thereof.

20. The system according to claim 1 , wherein the elongate device is configured to be translated through the duodenum without using fluoroscopy.

21. The system according to claim 1 , wherein the controller that is configured to perform an algorithm that controls the robotic manipulation.

Assignments (2)

Continuity (3)

References Cited (373)