Temporarily stiffened mesh prostheses
Inventors
Buevich, Fatima • Do, Frank • McJames, William • Pulapura, Satish • Edelman, William • Moses, Arikha • Diamond, Mason • Timothy, Shari
Assignees
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Publication Number
US-9987116-B2
Publication Date
2018-06-05
Expiration Date
Abstract
The present invention relates to medical prostheses and methods of manufacturing those devices. In particular, the prostheses are temporarily stiffened meshes with particular coatings to provide initial stiffness and thereby permit easier surgical handling for treatment or reconstruction of soft tissue defects. Preferred embodiments include surgical meshes coated with one or more biodegradable polymers that can act as a stiffening agent by coating the filaments or fibers of the mesh to temporarily immobilize the contact points of those filaments or fibers and/or by increasing the stiffness of the mesh by at least 1.1 times its original stiffness. The devices of the invention can also provide relief from various post-operative complications associated with their implantation, insertion or surgical use. By including biologically active agents and/or drugs in the coating, the devices provide prophylaxis for and can alleviate side effects or complications associated with the surgery or use of prostheses in general.
Core Innovation
The invention relates to medical prostheses that use a porous surgical mesh, where the mesh is temporarily stiffened by a polymer coating. The polymer coating is applied to the mesh without substantially altering a porosity of the surgical mesh. The coated mesh maintains the mesh porosity while providing increased stiffness that later reverts/softens as the coating degrades.
A tyrosine-derived polyarylate is used as part of the polymer coating for the porous surgical mesh prosthesis. The document describes embodiments in which the tyrosine-derived polyarylate is from a P22-xx family, including a specific member identified as P22-27.5. Coatings are described as localized at filament contact points such as woven knots, using templated/controlled deposition to preferentially immobilize filament contact points.
The polymer coating can further include biologically active agents, including antimicrobial agent combinations and an anesthetic. Exemplary antimicrobial combinations described include rifampin and minocycline. An anesthetic bupivacaine is also described, including embodiments with multilayer coating/release. The coated porous mesh prostheses are described for maintaining porosity while temporarily increasing stiffness and delivering selected agents over time as the coating degrades.
Claims Coverage
The provided independent claims (clm-00001, clm-00008, and clm-00015) cover medical prostheses with a porous surgical mesh, a polymer coating applied without substantially altering mesh porosity, and specific polymer/coating compositions. Across the independent claims, there are three core inventive feature groupings: (i) tyrosine-derived polyarylate-coated mesh while preserving porosity, (ii) addition of an antimicrobial agent to the tyrosine-derived polyarylate coating, and (iii) inclusion of chitosan together with the tyrosine-derived polyarylate in the coating composition.
Tyrosine-derived polyarylate coated porous mesh without substantially altering porosity
A medical prosthesis comprising a porous surgical mesh with a polymer coating, wherein the polymer coating is applied to the mesh without substantially altering a porosity of the surgical mesh, and wherein the polymer coating comprises a tyrosine-derived polyarylate.
Tyrosine-derived polyarylate plus antimicrobial agent coated porous mesh without substantially altering porosity
A medical prosthesis comprising a porous surgical mesh with a polymer coating, wherein the polymer coating is applied to the mesh without substantially altering a porosity of the surgical mesh, and wherein the polymer coating comprises a tyrosine-derived polyarylate and an antimicrobial agent.
Chitosan and tyrosine-derived polyarylate coated porous mesh without substantially altering porosity
A medical prosthesis comprising a porous surgical mesh with a polymer coating, wherein the polymer coating is applied to the mesh without substantially altering a porosity of the surgical mesh, and wherein the polymer coating comprises chitosan and a tyrosine-derived polyarylate.
The independent claims collectively require a porous surgical mesh coated with a polymer coating that does not substantially alter mesh porosity, with the coating chemistry defined by tyrosine-derived polyarylate (and optionally specified variants) and further optionally including an antimicrobial agent and/or chitosan.
Stated Advantages
Maintains mesh porosity while providing increased stiffness that later reverts/softens as the coating degrades.
Provides antimicrobial functionality via the antimicrobial agent included in the polymer coating.
Provides delivery of a biologically active agent, including bupivacaine, as described.
Documented Applications
Medical prostheses using porous surgical meshes that are temporarily stiffened by polymer coatings, including shaped/3D shaped/conformed meshes maintained by temporary stiffness.
Embodiments described for prophylaxis and reduction of complications using polymer coatings that include antimicrobial agents.
Dermal anesthesia outcomes are described in a rat pin-prick test using the coated mesh including bupivacaine.
An in vivo hernia model is described in connection with a Lichtenstein non-tension repair.
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