Absorbable, permeability-modulated barrier composites and applications thereof

• US 10,004,833 B2
• Filed: 11/13/2016
• Issued: 06/26/2018
• Est. Priority Date: 09/24/2008
• Status: Active Grant

• Current Assignee: Poly-Med, Inc.
• Original Assignee: Poly-Med, Inc.
• Inventors: Shalaby, Shalaby W.
• Primary Examiner(s): Tran, Susan T
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US15/350,067
• Publication Number:
  US 20170056564A1
• Time in Patent Office: 590 Days
• Field of Search: None
• 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:

a. at least three physiocochemically distinct components;

b. a first component comprising a flexible film comprising a synthetic absorbable polymer selected from the group consisting of

i. a polyaxial copolyester derived from at least two monomers selected from the group consisting of glycolide, lactide, ε

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

ii. a polyether ester derived from a polyether-glycol that is grafted with at least one monomer selected from the group consisting of glycolide, lactide, ε

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

iii. a polyether-ester-urethane derived from a polyether-glycol that is grafted with at least one monomer selected from the group consisting of glycolide, lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one and a morpholinedione, to form a polyether ester glycol, where the polyether ester glycol is interconnected by urethane linkages formed through the reaction of said polyether ester glycol with an aliphatic diisocyanate;

c. a second component comprising a knitted mesh; and

d. a third component comprising an electrostatically spun, non-woven microfibrous fabric;

wherein the flexible film is adjoined directly to the knitted mesh, and the knitted mesh is adjoined directly to the microfibrous fabric, to form a layered composite.

2. The composite of claim 1 wherein the synthetic absorbable polymer of the first component comprises a polyaxial copolyester derived from at least two monomers selected from the group consisting of glycolide, lactide, ε

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

3. The composite of claim 1 wherein the synthetic absorbable polymer of the first component comprises a polyether ester derived from a polyether-glycol that is grafted with at least one monomer selected from the group consisting of glycolide, lactide, ε

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

4. The composite of claim 1 wherein the synthetic absorbable polymer of the first component comprises a polyether-ester-urethane derived from a polyether-glycol that is grafted with at least one monomer selected from the group consisting of glycolide, lactide, ε

-caprolactone, trimethylene carbonate, p-dioxanone, 1,5-dioxepan-2-one and a morpholinedione, to form a polyether ester glycol, where the polyether ester glycol is interconnected by urethane linkages formed through the reaction of said polyether ester glycol with an aliphatic diisocyanate.

5. The composite of claim 1 wherein the flexible film has a thickness of less than 500 microns.

6. The composite of claim 1 wherein the microfibrous fabric comprises a polyaxial copolyester derived from at least two monomers selected from the group consisting of glycolide, lactide, ε

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

7. The composite of claim 1 wherein the microfibrous fabric comprises a polyether-ester derived from a polyether-glycol grafted with at least one monomer selected from the group consisting of glycolide, lactide, ε

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

8. A method of performing a spinal procedure in a subject in need thereof, the method comprising implanting an absorbable, permeability-modulated barrier composite of claim 1 as a dura mater prosthesis in the spinal area of the subject.

9. A method of performing a cranial procedure in a subject in need thereof, the method comprising implanting an absorbable, permeability-modulated barrier composite of claim 1 as a dura mater prosthesis in the cranial area of the subject.

10. A method of preventing surgical adhesions in a subject in need thereof, the method comprising implanting an absorbable, permeability-modulated barrier composite of claim 1 in the abdominal area of the subject who has undergone abdominal surgery.

11. A method of preventing surgical adhesions in a subject in need thereof, the method comprising implanting an absorbable, permeability-modulated barrier composite of claim 1 in the urinogenital region of the subject who has undergone urinogenital surgery.

12. A method for repairing or replacing a portion of a urinary bladder of a vertebrate animal, the method comprising applying an absorbable, permeability-modulated barrier composite of claim 1 as a patch to the urinary bladder of the vertebrate animal.

13. A method for repairing or replacing a portion of a blood vessel of a vertebrate animal, the method comprising applying an absorbable, permeability-modulated barrier composite of claim 1 as a patch to the blood vessel of the vertebrate animal.