Granted Patent B2

US 12,740,821 · App. 17/859,137 · Granted Sep 22, 2026

Inventors: Michael Biasella (Medford, MA); Sara Morneau (Lincoln, MA); Jay Caplan (Boston, MA); Michelle Riches (Leominster, MA); Philip Levin (Storrs, CT); Ryan Cahill (Scituate, MA); Keith Boudreau (North Andover, MA); Harith Rajagopalan (Wellesley Hills, MA); Brendan Zarechian (Reading, MA); Jeffrey Lesica (Holliston, MA); R. Maxwell Flaherty (Topsfield, MA); J. Christopher Flaherty (Nottingham, NH)

Assignee: Fractyl Health, Inc.

A61B18/04A61B2018/0022A61B2018/00494A61B2018/00577A61B2018/046

Abstract

Claims (31)

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

a guidewire;

an elongate shaft assembly comprising:

a shaft assembly first section comprising a distal section of the shaft assembly;

a shaft assembly second section proximal to the shaft assembly first section;

a shaft assembly third section proximal to the shaft assembly second section; and

a shaft assembly fourth section comprising a distal tip;

a functional assembly positioned on the shaft assembly first section, the functional assembly comprising an expandable element configured to expand to a diameter of at least 18 mm; and

a guidewire lumen configured to slidingly receive the guidewire,

wherein the shaft assembly first section terminates at a distal end of the functional assembly,

wherein the distal tip comprises a tapered portion of the shaft assembly extending beyond the distal end of the functional assembly,

wherein the distal tip comprises a proximal tip segment and a distal tip segment,

wherein the distal tip segment comprises a smaller diameter than the proximal tip segment,

wherein a taper and/or a wall thickness variation of the distal tip configures the proximal tip segment to have a stiffness greater than a stiffness of the guidewire and the distal tip segment to have a stiffness less than the stiffness of the guidewire, and

wherein a proximal end of the distal tip has a stiffness approximately equal to a stiffness of a distal end of the shaft assembly first section.

2 . The device according to claim 1 , wherein the shaft assembly comprises a multi lumen shaft.

3 . The device according to claim 2 , wherein the shaft assembly further comprises at least one conduit positioned within a lumen of the multi lumen shaft.

4 . The device according to claim 1 , wherein the shaft assembly first section comprises a length of at least 2 inches.

5 . The device according to claim 1 , wherein the shaft assembly second section comprises a length of at least 10 inches.

6 . The device according to claim 1 , wherein the shaft assembly third section comprises a length of at least 32 inches.

7 . The device according to claim 1 , wherein the shaft assembly third section is longer than the shaft assembly second section and the shaft assembly second section is longer than the shaft assembly first section.

8 . The device according to claim 1 , wherein the shaft assembly first section comprises a material with a durometer of approximately 40D, the shaft assembly second section comprises a material with a durometer of approximately 55D, and the shaft assembly third section comprises a material with a durometer of approximately 63D.

9 . The device according to claim 1 , wherein the shaft assembly third section comprises a length of approximately 57 inches, the shaft assembly second section comprises a length of approximately 10 inches, and the shaft assembly first section comprises a length of approximately 5 inches.

10 . The device according to claim 9 , wherein the shaft assembly first section comprises a material with a durometer of approximately 40D, the shaft assembly second section comprises a material with a durometer of approximately 55D, and the shaft assembly third section comprises a material with a durometer of approximately 63D.

11 . The device according to claim 1 , wherein the functional assembly is configured to expand tissue within the intestine of the patient.

12 . The device according to claim 1 , wherein the functional assembly is configured to ablate tissue within the intestine of the patient.

13 . The device according to claim 1 , wherein the functional assembly is configured to expand and ablate tissue within the intestine of the patient.

14 . The device according to claim 1 , wherein the functional assembly comprises a balloon configured to ablate tissue within the intestine of the patient with a hot fluid.

15 . The device according to claim 1 , further comprising an injection assembly including at least one needle, at least one port, and at least one fluid delivery tube.

16 . The device according to claim 1 , further comprising a fluid manifold secured across a transition between the shaft assembly second section and the shaft assembly first section, the fluid manifold being configured to route inflow and return flow to the functional assembly and to mechanically reinforce the transition against kinking.

17 . The device according to claim 1 , wherein a distal-most portion of the distal tip comprises a material having a durometer of less than 40D.

Assignments (2)

Continuity (3)

References Cited (385)