Absorbable, permeability-modulated barrier composites and applications thereof

• US 9,492,593 B2
• Filed: 09/24/2008
• Issued: 11/15/2016
• 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
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US12/284,657
• Publication Number:
  US 20100074941A1
• Time in Patent Office: 2,974 Days
• Field of Search: 424/424, 424/447, 606/213
• US Class Current: 1/1
• 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 three physicochemically distinct components;

one component comprising a flexible film having a thickness of less than 200 microns, the film comprising a synthetic absorbable polymer, a second component comprising a knitted mesh and a third component comprising an electrostatically spun, non-woven microfibrous fabric, and wherein the flexible film is adjoined directly to the knitted mesh which is adjoined directly to the microfibrous fabric to form a three component layered composite;

wherein the knitted mesh comprises an absorbable block copolymer comprising a block derived only from trimethylene carbonate and terminal segments derived from glycolide; and

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.

2. An absorbable, permeability-modulated barrier composite as in claim 1 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.

3. An absorbable, permeability-modulated barrier composite as in claim 1 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.

4. 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.

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

6. An absorbable, permeability-modulated barrier composite as in claim 5 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.

7. An absorbable, permeability-modulated barrier composite comprising:

at least three physicochemically distinct components, the first component comprising a flexible film having a thickness of less than 400 microns, the film comprising a synthetic absorbable polymer, the second component comprising an electrostatically spun, non-woven microfibrous fabric, and the third component comprising a knitted mesh, wherein the flexible film is adjoined directly to the knitted mesh and the microfibrous fabric is adjoined directly to the knitted mesh, such that the flexible film and the microfibrous fabric are indirectly joined to each other with the knitted mesh sandwiched therebetween;

wherein the knitted mesh comprises an absorbable copolymer formed from a block derived only from trimethylene carbonate and terminal segments derived from glycolide; and

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.

8. An absorbable, permeability-modulated barrier composite as in claim 7 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.

9. An absorbable, permeability-modulated barrier composite as in claim 7 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.

10. An absorbable, permeability-modulated barrier composite as in claim 7 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.