Electrically conductive hydrogels usable as lead extensions, apparatus for delivery of a hydrogel into the vasculature, and methods of treating ventricular arrhythmia with electrically conductive hydrogels injected in the venous system

Patent metadata

Field	Value
Publication number	US-12427284-B2
Application number	US-202017640147-A
Country	US
Kind code	B2
Filing date	Sep 4, 2020
Priority date	Sep 5, 2019
Publication date	Sep 30, 2025
Grant date	Sep 30, 2025

Abstract

A conductive hydrogel precursor solution cures after injection into the vasculature of the myocardium. The vasculature acts as a mold for the hydrogel and allows for a pacing signal to be conducted across the myocardium and not at a single point like traditional pacing leads. The catheter-based delivery can accurately place the hydrogels into the myocardial veins and can fill the venous tributaries. In situ crosslinking of the hydrogel precursor solution is achieved through several mechanisms, such as redox initiation by mixing a reducing reagent and oxidizing agent after injection. Conductivity is achieved by doping in conductive polymers or other conductive elements such as ionic species, metallic nanoparticles, or graphene nanoplatelets. To ensure long-term conductivity, hydrogel macromers may be synthesized without hydrolytically labile groups such as esters, and the conductive elements may be conjugated directly to the hydrogel matrix.

First claim

What is claimed is:

1. An apparatus for delivery of a curable substance into vasculature or an organ, comprising:
a mixing catheter having a first hollow lumen separated from a second hollow lumen, the first hollow lumen and the second hollow lumen being joined into an opening at a distal end of the mixing catheter;
a mechanism to deliver precursors of the curable substance, the mechanism to deliver the precursors of the curable substance being attached to the proximal end of the mixing catheter;
a mechanism for mixing of the precursors of the curable substance flowing in the first hollow lumen and the second hollow lumen to form the curable substance;
a mechanism to cleave the curable substance from the mixing catheter, including:
(i) a lasso-like member comprising a loop, wherein the loop has an expanded configuration and a contracted configuration, and an actuator to selectively move the loop into the expanded configuration or the contracted configuration; or
(ii) flaps elastically biased toward a close position, the flaps forming a valve; and

a mechanism to anchor the mixing catheter or prevent backflow of the curable substance.

2. The apparatus of claim 1 , wherein the mechanism for mixing includes bumps, ridges, or grooves in one or both lumens of the mixing catheter.

3. The mechanism of claim 1 , wherein the mechanism for mixing includes a mixing head at the distal end of the mixing catheter.

4. The mechanism of claim 1 , wherein the mechanism for mixing includes tubes having distal portions angled toward one another.

5. The apparatus of claim 1 , wherein the cleaving mechanism includes the lasso-like member.

6. The apparatus of claim 5 , wherein the actuator includes a concentrically inflatable balloon.

7. The apparatus of claim 5 , wherein the actuator includes a spoke surrounded by a casing.

8. The apparatus of claim 5 , further comprising means for supporting the lasso-like member on the distal end of the mixing catheter.

9. The apparatus of claim 1 , wherein the cleaving mechanism includes the flaps.

10. The apparatus of claim 1 , wherein the mechanism to anchor the mixing catheter or prevent backflow of the precursors includes an inflatable balloon on the body of the mixing catheter.

11. The apparatus of claim 1 , wherein the mechanism to deliver the precursors comprises a hub having at least two inlet ports offset from one another and a coaxial outlet port, a first inner channel connecting one of the at least two inlet ports to a central region of the coaxial outlet port, and a second inner channel connecting another of the at least two inlet ports to a peripheral region of the coaxial outlet port.

12. The apparatus of claim 11 , wherein the mechanism to deliver the precursors further comprises a dual-syringe connected to the at least two inlet ports.

13. The apparatus of claim 1 , further comprising a radio-opaque marker to navigate the mixing catheter.

14. The apparatus of claim 1 , further comprising an introducer sheath including a body having a hollow lumen sized to pass the mixing catheter, the introducer sheath including an inflatable balloon on the body.

15. A method of delivery of a curable substance, comprising:
providing an apparatus including:
a mixing catheter having a first hollow lumen separated from a second hollow lumen, the first hollow lumen and the second hollow lumen being joined into an opening at a distal end of the mixing catheter;
a mechanism to deliver precursors of the curable substance, the mechanism to deliver the precursors of the curable substance being attached to the proximal end of the mixing catheter;
a mechanism for mixing of the precursors of the curable substance flowing in the first hollow lumen and the second hollow lumen to form the curable substance;

a mechanism to cleave the curable substance from the mixing catheter, including:
(i) a lasso-like member comprising a loop, wherein the loop has an expanded configuration and a contracted configuration, and an actuator to selectively move the loop into the expanded configuration or the contracted configuration; or
(ii) flaps elastically biased toward a close position, the flaps forming a valve; and

a mechanism to anchor the mixing catheter or prevent backflow of the curable substance;
flowing a first precursor of the curable substance in the first hollow lumen;
flowing a second precursor of the curable substance in the second hollow lumen;
mixing the first precursor with the second precursor to form a mixture;
injecting the mixture into vasculature or an organ;
connecting a lead of a defibrillator or pacemaker to the mixture; and
curing the mixture.

16. The method of claim 15 , wherein the mixture is injected into the venous system of a patient heart.

17. The method of claim 16 , wherein the cured mixture is a hydrogel having a conductivity of at least 10 −4 S·cm −1 .

Assignees

• Texas Heart Inst
• Univ Texas

Inventors

• Cosgriff-Hernandez Elizabeth
• John Mathews
• Post Allison
• Razavi Mehdi
• Chwatko Malgorzata
• Rook Ashley
• Wilems Thomas

Classifications

• A61B2090/3966

  Radiopaque markers visible in an X-ray image · CPC title

• A61M2025/1052

  for temporarily occluding a vessel for isolating a sector · CPC title

• A61M2025/0073

  Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow · CPC title

• A61M25/0082

  Catheter tip comprising a tool · CPC title

• A61L2400/06

  Flowable or injectable implant compositions · CPC title