IP Library › Granted Patent US 12,478,426
Granted Patent B2
US 12,478,426 · App. 17/494,277 · Granted Nov 25, 2025

Injectate delivery devices, systems and methods

Inventors: Christopher J. Kadamus (Jamaica Plain, MA); Mark A. Manasas (Lexington, MA); Andrew Coats (Somerville, MA); Jay Caplan (Boston, MA); Harith Rajagopalan (Wellesley Hills, MA); R. Maxwell Flaherty (Topsfield, MA); J. Christopher Flaherty (Auburndale, FL)
Assignee: Fractyl Health, Inc.
A61B18/1492A61B18/1477A61M25/0084A61B2018/00023A61B2018/00041A61B2018/0022A61B2018/00494A61B2018/00577A61B2218/007
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Quick Facts
Patent No.
US 12,478,426
App. No.
17/494,277
Granted
Nov 25, 2025
Kind
B2
Abstract

An injectate delivery device for expanding tissue is provided. The injectate delivery device comprises: at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween; at least one fluid delivery element in fluid communication with the at least one fluid delivery tube lumen; a radially expanding element comprising the at least one fluid delivery element; a supply of vacuum constructed and arranged to cause tissue to tend toward the at least one fluid delivery element; and at least one control constructed and arranged to perform a function. The at least one control can be constructed and arranged to expand the radially expandable element and activate the supply of vacuum. Systems and method of injectate delivery are also provided.

Claims (52)

1 . An injectate delivery device for expanding tissue comprising:

at first tissue capture port comprising an opening;

a second tissue capture port comprising an opening;

a third tissue capture port comprising an opening:

a first fluid delivery tube comprising a proximal end, a distal end, and a lumen therebetween;

a first fluid delivery element in fluid communication with the first fluid delivery tube lumen, the first fluid delivery element constructed and arranged to be advanced into the first tissue capture port;

a second fluid delivery element constructed and arranged to be advanced into the second tissue capture port;

a third fluid delivery element constructed and arranged to be advanced into the third tissue capture port;

a radially expandable element comprising the first fluid delivery element the first tissue capture port, the second fluid delivery element, the second tissue capture port, the third fluid delivery element, and the third tissue capture port;

a supply of vacuum fluidly attached to the first tissue capture port, the second tissue capture port, and the third tissue capture port, the supply of vacuum constructed and arranged to cause tissue to be captured by the first tissue capture port, the second tissue capture port and the third tissue capture port; and

at least one control constructed and arranged to:

expand the radially expandable element; and

activate the supply of vacuum;

a vacuum lumen; and

a sensor constructed and arranged to detect an occlusion within the vacuum lumen;

wherein the injectate delivery device is constructed and arranged to deliver an injectate to target tissue through the first fluid delivery element, the second fluid delivery element, and the third fluid delivery element.

2 . The injectate delivery device according to claim 1 , wherein the first tissue capture port opening comprises a length of at least 0.1″ and a width of at least 0.04″.

3 . The injectate delivery device according to claim 2 , wherein the first tissue capture port opening comprises a length between 0.14″ and 0.20″.

4 . The injectate delivery device according to claim 2 , wherein the first tissue capture port opening comprises a width between 0.05″ and 0.08″.

5 . The injectate delivery device according to claim 2 , wherein the first tissue capture port opening comprises a width of 0.06″.

6 . The injectate delivery device according to claim 2 , wherein the first tissue capture port opening comprises a depth of at least 0.05″.

7 . The injectate delivery device according to claim 2 , wherein the first tissue capture port opening comprises a depth between 0.06″ and 0.10″.

8 . The injectate delivery device according to claim 2 , wherein the first tissue capture port opening comprises a depth of 0.08″.

9 . The injectate delivery device according to claim 1 , wherein the second tissue capture port comprises a length of at least 0.1″ and a width of at least 0.04″.

10 . The injectate delivery device according to claim 1 , wherein the first, second, and third tissue capture ports are disposed in a circumferential array.

11 . The injectate delivery device according to claim 10 , wherein the first, second, and third tissue capture ports are positioned 120° apart.

12 . The injectate delivery device according to claim 1 , wherein the first, second, and third fluid delivery elements are each configured to deliver at least 10 ml of injectate to the target tissue.

13 . The injectate delivery device according to claim 1 , wherein the supply of vacuum is further constructed and arranged to apply a positive pressure to the first tissue capture port.

14 . The injectate delivery device according to claim 13 , wherein the positive pressure is applied to flush material from the first tissue capture port.

15 . The injectate delivery device according to claim 1 , wherein the injectate comprises a visualizable media.

16 . The injectate delivery device according to claim 15 , wherein the visualizable material comprises methylene blue.

17 . The injectate delivery device according to claim 1 , wherein the injectate delivery device is constructed and arranged to deliver an insufflation fluid.

18 . The injectate delivery device according to claim 1 , wherein the injectate delivery device is constructed and arranged to perform an approximately full circumferential expansion of luminal wall tissue.

19 . The injectate delivery device according to claim 1 , wherein the injectate delivery device is constructed and arranged to create a therapeutic restriction in the gastrointestinal tract.

20 . The injectate delivery device according to claim 1 , wherein the radially expandable element is constructed and arranged to ablate tissue.

21 . The injectate delivery device according to claim 1 , wherein the supply of vacuum is configured for fluid connection to a vacuum source.

22 . An injectate delivery device for expanding tissue comprising:

at first tissue capture port comprising an opening;

a first fluid delivery tube comprising a proximal end, a distal end, and a lumen therebetween;

a first fluid delivery element in fluid communication with the first fluid delivery tube lumen, the first fluid delivery element constructed and arranged to be advanced into the first tissue capture port;

a radially expandable element comprising the first fluid delivery element and the first tissue capture port;

a supply of vacuum fluidly attached to the first tissue capture port, the supply of vacuum constructed and arranged to cause tissue to be captured by the first tissue capture port; and

at least one control constructed and arranged to:

expand the radially expandable element; and

activate the supply of vacuum;

a vacuum lumen; and

a sensor constructed and arranged to detect an occlusion within the vacuum lumen;

wherein the injectate delivery device is constructed and arranged to deliver an injectate to target tissue through the first fluid delivery element, and

wherein the supply of vacuum is further constructed and arranged to apply a positive pressure to the first tissue capture port.

23 . The injectate delivery device according to claim 22 , wherein the supply of vacuum is configured for fluid connection to a vacuum source.

24 . The injectate delivery device according to claim 23 , wherein the positive pressure is applied to flush material from the first tissue capture port.

25 . The injectate delivery device according to claim 22 , wherein the supply of vacuum is configured for fluid connection to a vacuum source.

Assignments (3)
SECURITY INTEREST Recorded Sep 7, 2023
From: FRACTYL HEALTH, INC.
To: SYMBIOTIC CAPITAL AGENCY LLC
Reel/Frame 064840/0561 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 5, 2021
From: KADAMUS, CHRISTOPHER J.; MANASAS, MARK A.; COATS, ANDREW; CAPLAN, JAY; RAJAGOPALAN, HARITH; FLAHERTY, R. MAXWELL; FLAHERTY, J. CHRISTOPHER
To: FRACTYL LABORATORIES, INC.
Reel/Frame 057704/0271 →
CHANGE OF NAME Recorded Oct 5, 2021
From: FRACTYL LABORATORIES, INC.
To: FRACTYL HEALTH, INC.
Reel/Frame 057731/0131 →
Continuity (9)
Continuation 17110720 · Dec 3, 2020
Continuation 16900563 · Jun 12, 2020
Continuation In Part 16742645 · Jan 14, 2020
Continuation PCTUS2018042438 · Jul 17, 2018
Continuation In Part 15274948 · Sep 23, 2016
Continuation PCTUS2015022293 · Mar 24, 2015
Provisional Application 62533569 · Jul 17, 2017
Provisional Application 61969417 · Mar 24, 2014
Related Publication 20220304744A1 · Sep 29, 2022
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