Granted Patent B2

US 12,690,909 · App. 18/062,331 · Granted Jul 28, 2026

Inventors: Jay Caplan (Boston, MA); Charles Abele (Brookline, MA); Gregory Andrew Dierksen (Brookline, MA); Andrew Hollett (Somerville, MA); Thomas C. Kochem (Watertown, MA); Adam Jaynes (Somerville, MA); Jeffrey Johnson (North Andover, MA); Jeffrey Lesica (Holliston, MA); Sara A. Morneau (Lincoln, MA); Bruno Piazzarolo (Arlington, MA); Jonathan Seidmann (Newton, MA)

Assignee: Fractyl Health, Inc.

A61B18/04A61B18/02A61B2018/00577A61B2018/00642A61B2018/00714A61B2018/0212A61B2018/0262A61B2018/046

Abstract

Claims (46)

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

a catheter for insertion into the intestine, the catheter comprising:

a shaft including a distal portion, and

a functional assembly positioned on the distal portion of the shaft, wherein the functional assembly is configured to receive fluid;

a console comprising:

a fluid reservoir configured to store the fluid,

a first syringe pump assembly comprising a first syringe and a first plunger configured to retract to draw fluid into the first syringe and to advance to deliver fluid from the first syringe to the functional assembly,

a second syringe pump assembly comprising a second syringe and a second plunger configured to retract to draw fluid into the second syringe and to advance to deliver the fluid from the second syringe to the functional assembly,

a fluid heater comprising a flow path configured to receive fluid in a first direction and in a second, opposite direction configured to heat the fluid flowing through the flow path, and

a waste fluid reservoir configured to receive the fluid from the functional assembly; and

a connector configured to operably attach the catheter to the console;

wherein the console is operable in a heating-and-delivery arrangement in which (i) retraction of the second plunger draws fluid from the functional assembly through the flow path of the fluid heater in the first direction while the fluid heater heats the fluid to produce warmed fluid within the second syringe, and (ii) thereafter, advancement of the second plunger forces the warmed fluid from the second syringe through the flow path of the fluid heater in the second direction while the fluid heater heats the warmed fluid to produce ablative-temperature fluid delivered to the functional assembly; and

wherein the system is configured to treat target tissue of the intestine of the patient.

2 . The system according to claim 1 , wherein the functional assembly comprises a balloon.

3 . The system according to claim 1 , wherein the system is configured to treat the target tissue by:

providing a first volume of the fluid at a temperature below body temperature and recirculating the first volume of the fluid within the functional assembly to cool the target tissue and tissue proximate the target tissue; and

providing a second volume of the fluid at an elevated ablative temperature and recirculating the second volume of the fluid within the functional assembly to ablate the target tissue.

4 . The system according to claim 3 , wherein the system is configured to deliver the first volume of the fluid prior to the delivery of the second volume of the fluid or after the delivery of the second volume of the fluid.

5 . The system according to claim 3 , wherein the system is configured to deliver the first volume of the fluid prior to the delivery of the second volume of the fluid, wherein the system is further configured to deliver a third volume of the fluid after the delivery of the second volume of the fluid, and wherein the third volume of the fluid comprises fluid at a temperature below body temperature that during its delivery cools the target tissue and tissue proximate the target tissue.

6 . The system according to claim 3 , wherein the fluid heater comprises an inline heater, and wherein the console is operable such that the second volume of the fluid is heated by the inline heater via two passes through the inline heater in a first direction during a fill stroke of the second syringe pump assembly and in a second, opposite direction during a dispense stroke of the second syringe pump assembly.

7 . The system according to claim 6 , wherein during the first pass through the inline heater, the inline heater is configured to be powered to a higher level than during the second pass through the inline heater.

8 . The system according to claim 3 , wherein the first volume of the fluid comprises fluid at room temperature.

9 . The system according to claim 3 , wherein the console is operable such that the treatment further comprises delivering a third volume of the fluid to cool the target tissue after the target tissue has been ablated.

10 . The system according to claim 9 , wherein the console is configured to prevent delivery of the second volume of fluid to the functional assembly unless a volume of at least the third volume of the fluid is present in the first syringe pump assembly prior to the delivery of the second volume of fluid to the functional assembly.

11 . The system according to claim 1 , wherein the fluid heater comprises an inline heater, and wherein the fluid heater is configured to be pre-heated prior to delivery of heated fluid to the functional assembly.

12 . The system according to claim 11 , wherein the system is configured to perform multiple treatment steps, and wherein the fluid heater is configured to be pre-heated between each of the multiple treatment steps.

13 . The system according to claim 1 , further comprising a closed-loop control algorithm configured to control the fluid heater.

14 . The system according to claim 1 , wherein the console is configured to determine one or more parameters related to the treatment of the target tissue, and wherein the one or more treatment parameters are selected from the group consisting of: a flow rate; a fluid temperature; an energy level; a pressure; a duration; and combinations thereof.

15 . The system according to claim 1 , wherein the console further comprises a backup power supply, wherein the backup power supply comprises an energy capacity sufficient to allow the system to transition one or more components of the system into a patient-safe mode, and wherein the system is configured to transition from a treatment mode to a patient-safe mode in the event of a power failure during treatment of the target tissue.

16 . The system according to claim 1 , wherein the console is configured to monitor one or more parameters of the system to assess the mechanical integrity of the catheter, and wherein the system is configured to monitor for leaks while fluid at an ablative temperature is being circulated through the functional assembly and to cause cooling fluid to be delivered to the functional assembly upon detection of a leak.

17 . The system according to claim 1 , wherein the system does not comprise more than two syringe pump assemblies configured to deliver fluid to the functional assembly, and wherein the first syringe pump assembly comprises a single syringe and the second syringe pump assembly comprises a single syringe.

18 . The system according to claim 1 , wherein the system is configured to prevent the treatment of target tissue if fluid in the fluid reservoir is not above a minimum volume.

19 . The system according to claim 1 , wherein the system is configured to prevent the treatment of target tissue if space in the waste reservoir is not above a minimum volume.

20 . The system of claim 1 , wherein the console comprises a first temperature sensor positioned proximate a first port of the fluid heater and a second temperature sensor positioned proximate a second port of the fluid heater, the first and second temperature sensors being configured to sense temperatures of fluid entering and exiting the fluid heater; and wherein the console controls power to the fluid heater based on the sensed temperatures.

21 . The system of claim 1 , wherein the fluid heater is operated at a first power level during the retraction of the second plunger and at a second power level during the advancement of the second plunger, the second power level being less than the first power level.

22 . A console for performing a medical procedure in the intestine of a patient, the console comprising:

a connector configured to operably attach to a catheter, the catheter being insertable into the intestine and comprising a balloon configured to receive fluid for thermal ablation;

a fluid reservoir interface configured to receive a fluid reservoir containing the fluid;

a first syringe pump assembly comprising a first syringe and a first plunger configured to retract to draw the fluid into the first syringe and to advance to deliver the fluid from the first syringe to the catheter;

a second syringe pump assembly comprising a second syringe and a second plunger configured to retract to draw the fluid into the second syringe and to advance to deliver the fluid from the second syringe to the catheter;

a fluid heater comprising a flow path in fluid communication with the second syringe pump assembly, the flow path being configured to convey fluid in a first direction and in a second, opposite direction, and the fluid heater being configured to heat fluid flowing through the flow path; and

a waste reservoir interface configured to receive a waste fluid reservoir configured to receive the fluid from the catheter;

wherein the console is operable in a heating-and-delivery arrangement in which (i) retraction of the second plunger draws fluid from the catheter through the flow path of the fluid heater in the first direction while the fluid heater heats the fluid to produce warmed fluid within the second syringe, and (ii) thereafter, advancement of the second plunger forces the warmed fluid from the second syringe through the flow path of the fluid heater in the second direction while the fluid heater heats the warmed fluid to produce ablative-temperature fluid delivered to the catheter;

wherein the console is configured to treat target tissue of the intestine of the patient when the catheter is connected to the connector.

23 . The console of claim 22 , further comprising a first temperature sensor positioned proximate a first port of the fluid heater and a second temperature sensor positioned proximate a second port of the fluid heater, the first and second temperature sensors being configured to sense temperatures of fluid entering and exiting the fluid heater, wherein the console is configured to control power to the fluid heater based on the sensed temperatures.

24 . The console of claim 22 , wherein the console is operable such that the fluid heater is powered at a first power level while the second plunger retracts to draw fluid through the flow path in the first direction, and is powered at a second power level while the second plunger advances to force fluid through the flow path in the second direction, the second power level being less than the first power level.

Assignments (2)

Continuity (3)

References Cited (383)