Polyurethane-reinforced hydrogel cardiac patch

Patent metadata

Field	Value
Publication number	US-2022265254-A1
Application number	US-202017634676-A
Country	US
Kind code	A1
Filing date	Aug 13, 2020
Priority date	Aug 14, 2019
Publication date	Aug 25, 2022
Grant date	—

Abstract

Disclosed herein are devices and methods for repairing a heart defect. The disclosed devices, comprising a biodegradable gel and a biodegradable mesh scaffold, enhance cellular infiltration, vascularization, and degredation, while reducing fibrosis and rejection. In many embodiments, the mesh scaffold comprises one or more of polycaprolactone, gelatin, and polyurethane, and the gel comprises a biologically active compound decorated with polyethylene glycol. The disclosed heart patch devices possess elasticity and strength similar existing patch products derived from mammalian pericardium.

First claim

We claim:

1 . A heart patch device comprising;
a biodegradable polymeric mesh scaffold; and a biodegradable gel.

2 . The heart patch device of claim 1 , wherein the polymeric mesh scaffold is made of a material comprising one or more of gelatin, polyurethane, and polycaprolactone.

3 . The heart patch device of any of claim 1 or 2 , wherein the gel comprises one or more of fibrin and polyethylene glycol.

4 . The heart patch device of any of claims 1 - 3 , wherein the gel comprises fibrinogen.

5 . The heart patch device of any of claims 1 - 4 , wherein the gel comprises fibrinogen with one or more polyethylene glycol molecules.

6 . The heart patch device of any of claims 1 - 5 , wherein the gel further comprises thrombin.

7 . The heart patch device of any of claims 1 - 6 , wherein the polymeric mesh scaffold comprises biodegradable polyurethane.

8 . The heart patch device of any of claims 1 - 7 , further comprising one or more cells selected from a stem cell, an endothelial cell, and mixtures thereof.

9 . The heart patch device of any of claims 1 - 8 , further comprising one or more of umbilical vein endothelial cells and induced stem cells.

10 . A method for making the heart patch device, comprising;
forming a mesh scaffold by electrospinning, wherein the mesh scaffold comprises a biodegradable polymer; forming a gel layer, wherein the gel is biodegradable; and combining the mesh scaffold with the gel layer.

11 . The method of claim 10 , wherein additional gel is added to the mesh scaffold after it is adjacent the gel layer.

12 . The method of claim 10 or claim 11 , wherein the polymeric mesh scaffold is electrospun in the presence of polycaprolactone.

13 . The method of any of claims 10 - 12 , wherein the gel comprises one or more of fibrin and polyethylene glycol.

14 . The method of any of claims 10 - 13 , wherein the gel comprises fibrinogen.

15 . The method of any of claims 10 - 14 , wherein the gel comprises polyethylene glycol molecules conjugated to fibrinogen.

16 . The method of any of claims 10 - 15 , wherein the gel further comprises thrombin.

17 . The method of any of claims 10 - 16 , wherein the polymeric mesh scaffold comprises biodegradable polyurethane.

18 . The method of any of claims 10 - 17 , wherein one or more cells selected from a stem cell, an endothelial cell, and mixtures thereof are added to the gel before combining with the mesh scaffold.

19 . The method of any of claims 10 - 18 , wherein one or more of umbilical vein endothelial cells and induced stem cells are added to the gel before combining with the mesh scaffold.

20 . The method of any of claims 10 - 17 , wherein one or more cells selected from a stem cell, an endothelial cell, and mixtures thereof are added to the patch after combining the gel with the mesh scaffold.

21 . The method of any of claims 10 - 18 , wherein one or more of umbilical vein endothelial cells and induced stem cells are added to the patch after combining the gel with the mesh scaffold.

22 . The method of any of claims 18 - 21 , wherein the patch is incubated in culture media for from 0 to 336 hours.

23 . A method of treating a subject having a heart defect, the method comprising:
obtaining a heart patch device, the heart patch device comprising
a biodegradable polymeric mesh scaffold; and
a biodegradable gel
placing the heart patch device at or near the heart defect; connecting the heart patch device to the heart with one or more sutures; and thereby treating the subject having the heart defect.

24 . The methods of claim 23 , wherein the heart patch device includes one or more mammalian cells.

25 . The methods of claim 23 or 24 , wherein the heart patch device includes one or more autologous cells.

26 . The methods of any of claims 23 - 25 , wherein the heart patch device includes one or more non-autologous cells.

27 . The methods of any of claims 23 - 26 , wherein the heart patch device includes one or more cells expressing one or more of CD31 (PECAM1), CD144 (VE-Cadherin), and CD309 (VEGFR2).

28 . The methods of any of claims 23 - 27 , wherein the heart patch device includes one or more stem cells.

29 . The methods of claim 28 , wherein the stem cells are induced stem cells.

30 . The method of any of claims 23 - 29 , wherein the gel comprises one or more of fibrin and polyethylene glycol.

31 . The method of any of claims 23 - 30 , wherein the gel comprises fibrinogen.

32 . The method of any of claims 23 - 31 , wherein the gel comprises polyethylene glycol molecules conjugated to fibrinogen.

33 . The method of any of claims 23 - 32 , wherein the gel further comprises thrombin.

34 . The method of any of claims 23 - 33 , wherein the polymeric mesh scaffold comprises biodegradable polyurethane.

35 . The method of any of claims 23 - 34 , wherein the heart patch device comprises one or more of umbilical vein endothelial cells and induced stem cells.

36 . The method of any of claims 23 - 35 , wherein the patch is incubated in culture media for from 0 to 336 hours.

Assignees

• Univ Colorado Regents

Inventors

• Jacot Jeffrey G
• Tao Zei-Wei
• Lyons Anne C
• Beck Emily C

Classifications

• A61B2017/00243

  cardiac · CPC title

• A61L27/48

  with macromolecular fillers · CPC title

• A61L2430/20

  for reconstruction of the heart, e.g. heart valves · CPC title

• A61L27/52 Primary

  Hydrogels or hydrocolloids · CPC title

• A61B2017/00597

  Implements comprising a membrane · CPC title