Tissue scaffold

• US 9,642,943 B2
• Filed: 09/08/2014
• Issued: 05/09/2017
• Est. Priority Date: 11/09/2004
• Status: Active Grant

• Current Assignee: Proxy Biomedical Limited
• Original Assignee: Proxy Biomedical Limited
• Inventors: Gingras, Peter
• Primary Examiner(s): DAVIS, RUTH A
• Application Number:
  US14/479,651
• Publication Number:
  US 20140374004A1
• Time in Patent Office: 974 Days
• CPC Class Codes: A61F 2/00 Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents as cosmetic articles, see the relevant subclasses, e.g. wigs, hair pieces, A41G3/00, A41G5/00; artificial nails A45D31/00; dental prostheses A61C13/00; materials for prostheses A61L27/00; artificial hearts A61M60/00; artificial kidneys A61M1/14
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/105 Skin implants, e.g. artificial skin
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30032 differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30148 lozenge- or diamond-shaped
• CPC Class Codes: A61F 2002/30154 square
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30228 Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30762 : Means for culturing cartilage
• CPC Class Codes: A61F 2002/30766 : Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/3093 : for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30952 : using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4648 : Means for culturing bone graft
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0021 : square
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61L 27/16 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: B32B 2038/042 : Punching
• CPC Class Codes: B32B 2038/047 : Perforating
• CPC Class Codes: B32B 2367/00 : Polyesters, e.g. PET, i.e. polyethylene terephthalate
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 37/12 : characterised by using adhesives
• CPC Class Codes: B32B 37/153 : at least one layer is extruded and immediately laminated while in semi-molten state
• CPC Class Codes: B32B 38/0008 : Electrical discharge treatment, e.g. corona, plasma treatment; wave energy or particle radiation heat treatment B32B38/0036
• CPC Class Codes: B32B 38/04 : Punching, slitting or perforating
• CPC Class Codes: Y10T 156/1056 : Perforating lamina

Abstract

A tissue scaffold includes a first film having a plurality of cell openings and a second film adjacent the first film and having a plurality of cell openings larger than the cell openings of the first film. The cell openings of the first film interconnect with the cell openings of the second film to define pathways extending through the first and second films.

Claims

1. A method of producing a tissue scaffold, the method comprising:

extruding a first biocompatible polymer to form a first film;

extruding a second biocompatible polymer to form a second film;

axially orienting the first and second film by applying a mechanical force and/or load to the first and second films;

bonding the first film to the second film to produce a tissue scaffold; and

forming a plurality of cell openings in the tissue scaffold to produce pores in the tissue scaffold such that cell openings of the first film interconnect with cell openings of the second film to define pathways with interconnecting pores of controlled area extending from the first film to the second film;

wherein the diameter of a majority of the pores is less than the diameter of the cell openings of the first and second films that define each pore.

2. The method of claim 1, wherein at least one of the first and second films further comprises alignment holes to align the cell openings of the first and second films when attached together.

3. The method of claim 1, wherein at least one of the films is an oriented film.

4. The method of claim 1, wherein the first film comprises a first material and the second film comprises a second material, wherein the first material has a higher absorption rate than the second material.

5. The method of claim 1, wherein the cell openings are formed to have diameters of between about 10 to about 10,000 microns.

6. The method of claim 1, wherein the cell openings of the second film are offset in a predetermined arrangement from the cell openings of the first film.

7. The method of claim 6, wherein the cell openings from the first film are offset and interconnect with the cell openings from the second film to create a 250 micron interconnecting pore.

8. The method of claim 6, wherein the predetermined arrangement of the cell openings creates a gradient of higher porosity on an edge of the tissue scaffold to lower porosity in the center which, in turn, creates a gradient of interconnecting pores with higher interconnecting areas on the edge of the edge.

9. The method of claim 1, further comprising the step of placing a hydrogel film between the first and second films before the first film is bonded to the second film.

10. A method of producing a tissue scaffold, the method comprising:

forming cell openings in a first film to define a first porosity;

forming cell openings in a second film to define a second porosity;

aligning the first film with respect to the second film; and

attaching the first and second films such that cell openings of the first film interconnect with cell openings of the second film to define pathways with interconnecting pores of controlled area extending from the first film to the second film;

wherein the diameter of a majority of the pores is less than the diameter of the cell openings of the first and second films that define each pore.

11. The method of claim 10, wherein the second porosity is greater than the first porosity.

12. The method of claim 10, wherein the cell openings of the second film are offset in a predetermined arrangement from the cell openings of the first film.

13. The method of claim 10, wherein the first porosity and the second porosity define a controlled porosity gradient extending from the first to the second film to selectively promote cellular regeneration along the gradient.

14. The method of claim 10, wherein the second film includes a plurality of alignment holes.

15. A method of producing a tissue scaffold, the method comprising:

(a) extruding a first biocompatible polymer to form a first film;

(b) extruding a second biocompatible polymer to form a second film;

(c) forming in the cell openings in a first and second films to define a first porosity and a second porosity, respectively; and

(d) attaching the first and second films such that cell openings of the first film interconnect with cell openings of the second film to define pathways with interconnecting pores of controlled area extending from the first film to the second film;

wherein the diameter of a majority of the pores is less than the diameter of the cell openings of the first and second films that define each pore.

16. The method of claim 15, wherein the second porosity is greater than the first porosity.

17. The method of claim 15, wherein the cell openings of the second film are offset in a predetermined arrangement from the cell openings of the first film.

18. The method of claim 15, wherein the first porosity and the second porosity define a controlled porosity gradient extending from the first to the second film to selectively promote cellular regeneration along the gradient.