Gels and related methods for treating fistulas

Patent metadata

Field	Value
Publication number	US-2025058020-A1
Application number	US-202418807099-A
Country	US
Kind code	A1
Filing date	Aug 16, 2024
Priority date	Aug 18, 2023
Publication date	Feb 20, 2025
Grant date	—

Abstract

The present disclosure includes kits, compositions, and methods useful in medical procedures, such as treating a fistula or other target site of a subject. In some examples, the kit may comprise a dry particulate mixture, a first pharmaceutically acceptable buffer solution having a pH ranging from about 3 to about 5, and a second pharmaceutically acceptable buffer solution having a pH ranging from about 9 to about 11. The dry particulate mixture may comprise a plurality of polyethylene glycol particles and a plurality of collagen particles.

First claim

What is claimed is:

1 . A kit for treating a fistula, the kit comprising:
a dry particulate mixture comprising:
a plurality of polyethylene glycol particles; and
a plurality of collagen particles;
a first pharmaceutically acceptable buffer solution having a pH ranging from about 3 to about 5; and a second pharmaceutically acceptable buffer solution having a pH ranging from about 9 to about 11.

2 . The kit of claim 1 , wherein the first pharmaceutically acceptable buffer solution comprises at least one crosslinking agent.

3 . The kit of claim 2 , wherein the at least one crosslinking agent comprises from trilysine acetate, N-(3-dimethylaminopropyl)-N′-ethylcarbodiimide hydrochloride, or N-hydroxysuccinimide.

4 . The kit of claim 1 , further comprising instructions for combining the dry particulate mixture with the first pharmaceutically acceptable buffer solution and the second pharmaceutically acceptable buffer solution to form a gel for application to a fistula.

5 . The kit of claim 4 , further comprising a double-barreled syringe, wherein the instructions combining the dry particulate mixture with the first pharmaceutically acceptable buffer solution to form a slurry, introducing the slurry into a first barrel of the syringe, and introducing the second pharmaceutically acceptable buffer solution into a second barrel of the syringe.

6 . The kit of claim 1 , wherein a weight ratio of the plurality of polyethylene glycol particles to the plurality of collagen particles in the dry particulate mixture ranges from about 8:1 to about 6:1.

7 . The kit of claim 1 , wherein the plurality of collagen particles has an average particle size ranging from about 300 μm to about 500 μm.

8 . The kit of claim 1 , wherein the plurality of polyethylene glycol particles comprises a polyethylene glycol polymer comprising one or more functional groups chosen from carboxylic acid groups, ester groups, amine groups, or a combination thereof.

9 . The kit of claim 8 , wherein the one or more functional groups comprise succinimide groups.

10 . The kit of claim 1 , wherein the first pharmaceutically acceptable buffer solution or the second pharmaceutically acceptable buffer solution comprises a radiopaque material, an antimicrobial agent, or both a radiopaque material and an antimicrobial agent.

11 . A method of treating a subject, the method comprising:
combining a dry particulate mixture with a first pharmaceutically acceptable buffer solution having a pH ranging from about 3 to about 5 to form a slurry, wherein the dry particulate mixture comprises a plurality of polyethylene glycol particles and a plurality of collagen particles; and combining the slurry with a second pharmaceutically acceptable buffer solution having a having a pH ranging from about 9 to about 11 at a target site of the subject to form a gel at the target site.

12 . The method of claim 11 , wherein the plurality of collagen particles has an average particle size ranging from about 300 μm to about 500 μm.

13 . The method of claim 11 , wherein the first pharmaceutically acceptable buffer solution comprises a crosslinking agent.

14 . The method of claim 11 , wherein the target site is a fistula of a gastrointestinal tract of the subject.

15 . The method of claim 11 , wherein the gel forms within 30 seconds of combining the slurry with the second pharmaceutically acceptable buffer solution at the target site.

16 . The method of claim 11 , wherein the plurality of polyethylene glycol particles comprises a polyethylene glycol polymer comprising one or more functional groups chosen from carboxylic acid groups, ester groups, amine groups, or a combination thereof.

17 . A method of treating a subject, the method comprising:
administering, to a target site of the subject, a slurry comprising:
a plurality of polyethylene glycol particles;
a plurality of collagen particles; and
a first pharmaceutically acceptable buffer solution having a pH ranging from about 3 to about 5; and
administering, to the target site, a second pharmaceutically acceptable buffer solution having a pH raging from about 9 to about 11 to combine with the slurry; wherein the slurry and the second pharmaceutically acceptable buffer solution form a gel at the target site within 30 seconds of being combined at the target site; and wherein the target site is a fistula of a gastrointestinal tract of the subject.

18 . The method of claim 17 , wherein the slurry and the second pharmaceutically acceptable buffer solution are administered to the target site at the same time.

19 . The method of claim 17 , wherein the plurality of polyethylene glycol particles comprises a polyethylene glycol polymer comprising one or more functional groups chosen from carboxylic acid groups, ester groups, amine groups, or a combination thereof.

20 . The method of claim 17 , wherein the slurry and the second pharmaceutically acceptable buffer solution are administered using a double-barreled syringe, wherein a first barrel of the syringe comprises the slurry and a second barrel of the syringe comprises the second pharmaceutically acceptable buffer solution.

Assignees

• Boston Scient Scimed Inc

Inventors

• Coughlan Robert
• Looney Mark
• Nugent Patrick
• Devlin Edward Joseph
• Murphy John
• Chrobak Megan
• O’Donovan Darragh
• O’Sullivan Conor

Classifications

• A61L2430/34

  for soft tissue reconstruction · CPC title

• A61L27/58

  Materials at least partially resorbable by the body · CPC title

• A61L27/52

  Hydrogels or hydrocolloids · CPC title

• A61L27/18

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61L2400/06

  Flowable or injectable implant compositions · CPC title