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Reinforced foam implants with enhanced integrity for soft tissue repair and regeneration
| Details |
Inventors: Bowman, Steven M.; Bruker, Izi; Rezania, Alireza;
Assignee: DePuy Mitek, Inc. (Norwood, MA)
Primary Examiner: Azpuru; Carlos A.
Assistant Examiner:
Attorney, Agent or Firm: McClennen & Fish LLP
A biocompatible tissue repair stimulating implant or "scaffold" device, and methods for making and using such a device, are provided. The implant includes one or more layers of a bioabsorbable polymeric foam having pores with an open cell pore structure. A reinforcement component is also present within the implant to contribute enhanced mechanical and handling properties. The implant houses a biological component that may be released to tissue adjacent the location in which the implant is implanted to faciliate and/or expedite the healing of tissue. This biological component resides primarily within the foam component of the implant, being incorporated within pores formed within the foam. |
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DETAILED DESCRIPTION This invention relates to bioabsorbable, porous, reinforced, biocompatible tissue repair stimulating implant, or "scaffold," devices for use in the repair and/or regeneration of diseased or damaged tissue, and the methods for making and using these devices.
The implants comprise a bioabsorable polymeric foam component having pores with an open cell pore structure.
The foam component is reinforced with a material such as a mesh.
Preferably, the implant has sufficient structural integrity to enable it to be handled in the operating room prior to and during implantation.
These implants should also have sufficient properties (e.
g.
, tear strength) to enable them to accept and retain sutures or other fasteners without tearing.
Desirable properties are imparted to the implant of the invention by integrating the foam component with the reinforcement component.
That is, the pore-forming webs or walls of the foam component penetrate the mesh of the reinforcement component so as to interlock therewith.
The implant may include one or more layers of each of the foam and reinforcement components.
Preferably, adjacent layers of foam are also integrated by at least a partial interlocking of the pore-forming webs or walls in the adjacant layers.
The implants of the instant invention further comprise at least one biological component that is incorporated therein.
The reinforcement material is preferably a mesh, which may be bioabsorbable.
The reinforcement should have a sufficient mesh density to permit suturing, but the density should not be so great as to impede proper bonding between the foam and the reinforcement.
A preferred mesh density is in the range of about 12 to 80%.
The biological component of the present invention comprises at least one effector molecule and/or cell, which contributes to the healing process of an injured tissue.
Collectively, these materials are sometimes referred to herein as "effectors.
" The effectors can be a cellular factor such as a protein or peptide (for the sake of simplicity, use of the term "protein" herein will include peptide), a non-protein biomolecule, a cell type, a pharmaceutical agent, or combinations thereof
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