Method of providing interconnected pores with a growth-promoting medium for controlled tissue integration

• US 10,278,751 B2
• Filed: 10/13/2014
• Issued: 05/07/2019
• Est. Priority Date: 10/11/2013
• Status: Active Grant

• Current Assignee: Proxy Biomedical Limited
• Original Assignee: Proxy Biomedical Limited
• Inventors: Durkin, Tony, Breathnach, Cormac, Rooney, Niall, Gingras, Peter
• Primary Examiner(s): Boles, Sameh
• Application Number:
  US15/027,779
• Publication Number:
  US 20160242831A1
• Time in Patent Office: 1,667 Days
• Field of Search: None
• CPC Class Codes: A61B 17/84 Fasteners therefor or fasteners being internal fixation devices
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30772 Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30784 Plurality of holes
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention is concerned with a method of manufacturing a tissue-integration device, and a tissue-integration device so produced, the method comprising the steps of wrapping a porous sheet of material around a mandrel in order to create overlapping layers of the porous sheet material, the wrapped mandrel then being placed in a mould in order to apply pressure and heat to the overlapping layers in order to effect the lamination thereof such as to form a device having spaces defined by overlapping pores of the adjacent layers.

Claims

1. A method of manufacturing a tissue-integration device, the method comprising the step of:

overlapping layers of a porous sheet material to form the device and such as to create spaces defined by overlapping pores of adjacent layers;

compressing the layers together to at least partially laminate the layers of the device, wherein the compression step is undertaken in two stages, wherein the first stage in the compression step comprises applying pressure to the layers before the addition of the growth-promoting medium to at least partially laminate the layers, wherein the second stage in the compression step comprises applying pressure to the partially laminated layers following the addition of the growth-promoting medium; and

forming an outer profile on the device during the second stage of the compression step.

2. A method according to claim 1 comprising the step of at least partially filling at least some of the pores with a growth-promoting medium before or after the overlapping step.

3. A method according to claim 1 comprising the step of rolling the sheet material into a tube of concentric layers.

4. A method according to claim 1 comprising the step of wrapping the sheet material around a mandrel to establish the layers of the device.

5. A method according to claim 1 comprising the step of forming an outer profile on the device during the compression step.

6. A method according to claim 1 comprising overlapping the pores of adjacent layers such as to create at least one pathway between an outer and an inner surface of the device.

7. A method according to claim 1 comprising the step of applying heat to the sheet material during the compression step.

8. A method according to claim 1 comprising the step of orienting at least one of the layers of sheet material prior to overlapping.

9. A method according to claim 8 in which multiple layers of sheet material are oriented prior to overlapping and in which the orientation is varied between overlapping layers.