Absorbable, permeability-modulated barrier composites and applications thereof

• US 20100074941A1
• Filed: 09/24/2008
• Published: 03/25/2010
• Est. Priority Date: 09/24/2008
• Status: Active Grant

• Current Assignee: Poly-Med, Inc.
• Original Assignee: Poly-Med, Inc.
• Inventors: Shalaby, Shalaby W.
• Granted Patent: US 9,492,593 B2
• Time in Patent Office: Days
• US Class Current: 424/424
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61L 2430/22 for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: D01D 5/003 the material being a polymer solution or dispersion D01D5/0053 takes precedence

Abstract

Absorbable barrier composites are designed for modulated gas and water permeability depending on clinical use and are formed of at least two physicochemically distinct components, one of which is a film adjoined to a knitted mesh and/or electrostatically spun, non-woven fabric. Depending on the physicochemical properties of the barrier composite, it can be used in neurological and urinogenital surgical procedures as well as tissue engineering and/or as physical barriers to prevent adhesion formation following several types of surgical procedures.

Claims

1. An absorbable, permeability-modulated barrier composite comprising at least two physicochemically distinct components, one component comprising a flexible film having a thickness of less than about 500 microns.

2. An absorbable, permeability-modulated barrier composite as in claim 1 wherein the flexible film has a thickness of less than about 200 microns, wherein the at least one other component comprises an electrostatically spun, non-woven microfibrous fabric, and wherein the flexible film is adjoined directly to the microfibrous fabric.

3. An absorbable, permeability-modulated barrier composite as in claim 2 wherein the flexible film is made of a polyaxial copolyester derived from at least two monomers selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

4. An absorbable, permeability-modulated barrier composite as in claim 2 wherein the flexible film is made of a polyether-ester derived from a polyether-glycol grafted with at least one monomer selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

5. An absorbable, permeability-modulated barrier composite as in claim 2 wherein the flexible film is made of a polyether-ester-urethane derived from a polyether-glycol grafted with at least one monomer selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione, and wherein the resulting chains of the polyether-ester-glycol are interconnected by urethane linkages formed through reaction with an aliphatic diisocyanate.

6. An absorbable, permeability-modulated barrier composite as in claim 2 wherein the electrostatically spun, non-woven fabric is made of a polyaxial copolyester derived from at least two monomers selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

7. An absorbable, permeability-modulated barrier composite as in claim 2 wherein the electrostatically spun, non-woven fabric is made of a polyether-ester derived from a polyether-glycol grafted with at least one monomer selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

8. An absorbable, permeability-modulated barrier composite as in claim 2 for use as a dura mater prosthesis in spinal and cranial surgical procedures.

9. An absorbable, permeability-modulated barrier composite as in claim 2 for use in preventing adhesion formation following abdominal and urinogenital surgical procedures.

10. An absorbable, permeability-modulated barrier composite as in claim 1 wherein the flexible film has a thickness of less than about 400 microns and wherein the flexible film is adjoined directly to a knitted mesh and indirectly to an electrostatically spun, non-woven microfibrous fabric.

11. An absorbable, permeability-modulated barrier composite as in claim 10 wherein the flexible film is made of a polyaxial copolyester derived from at least two monomers selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

12. An absorbable, permeability-modulated barrier composite as in claim 10 wherein the flexible film is made of polyether-ester derived from a polyether-glycol grafted with at least one monomer selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

13. An absorbable, permeability-modulated barrier composite as in claim 10 wherein the flexible film is made of polyether-ester-urethane derived from a polyether-glycol grafted with at least one monomer selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione, and wherein the resulting chains of the polyether-ester-glycol are interconnected by urethane linkages formed through reaction with an aliphatic diisocyanate.

14. An absorbable, permeability-modulated barrier composite as in claim 10 wherein the electrostatically spun, non-woven fabric is made of a polyaxial copolyester derived from at least two monomers selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

15. An absorbable, permeability-modulated barrier composite as in claim 10 wherein the electrostatically spun, non-woven fabric is made of a polyether-ester derived from a polyether-glycol grafted with at least one monomer selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

16. An absorbable, permeability-modulated barrier composite as in claim 10 wherein the knitted mesh comprises a warp-knitted construction and is made of a polyaxial copolyester derived from at least two monomers selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

17. An absorbable, permeability-modulated barrier composite as in claim 10 wherein the knitted mesh comprises a warp-knitted construction and is made of a polyether-ester derived from a polyether-glycol grafted with one monomer selected from the group consisting of glycolide, l-lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one, and a morpholinedione.

18. An absorbable, permeability-modulated barrier composite as in claim 10 for use as a patch for repairing or replacing part of the urinary bladder of a vertebrate animal.

19. An absorbable, permeability-modulated barrier composite as in claim 10 for use as a vascular patch for repairing or replacing part of a blood vessel of a vertebrate animal.

20. An absorbable, permeability-modulated barrier composite as in claim 1 wherein at least one of the components comprises at least one bioactive agent selected from the group consisting of antimicrobial agents, anesthetic agents, anti-inflammatory agents, and tissue growth-promoting agents.

21. An absorbable, permeability-modulated barrier composite as in claim 1 wherein at least one of the components comprises a hydroswellable polymer.

22. An absorbable, permeability-modulated barrier composite as in claim 21 wherein at least one of the components comprises at least one bioactive agent selected from the group consisting of antimicrobial agents, anesthetic agents, anti-inflammatory agents, and tissue growth-promoting agents.