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-10765500-B2
Publication Date
2020-09-08
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 temporarily stiffened porous surgical meshes for soft-tissue repair. A medical prosthesis includes a surgical mesh having a coating that maintains the mesh as porous while increasing stiffness for easier handling. The coating includes a first layer and a second layer, where the first layer is positioned between the mesh and the second layer.
The coating is applied without substantially altering a porosity of the mesh, while using different polymers in the first and second layers. At least one of the polymers comprises a tyrosine-derived polyarylate. In described embodiments, drug-loaded coatings are provided, including antimicrobial agents such as rifampin and minocycline and anesthetics such as bupivacaine, with coating layers configured as depot/release concepts.
The described system can include polymer combinations and film/coat localization at filament contact points and knots of woven meshes, with the coating immobilizing drug within the mesh structure. After degradation of biodegradable components and/or changes in hydrogel coatings, the mesh reverts toward original flexibility while preserving porosity.
Claims Coverage
The provided independent claims cover a medical prosthesis defined by a surgical mesh with a two-layer coating applied without substantially altering mesh porosity, using different polymers between the layers, and including tyrosine-derived polyarylate; additional independent constraints specify either a water soluble drug dissolved in a water soluble first layer or a rifampin and minocycline mixture.
Two-layer coated porous surgical mesh with interposed first layer and tyrosine-derived polyarylate
A medical prosthesis comprising a surgical mesh with a coating including a first layer and a second layer, the first layer positioned between the mesh and the second layer; the coating applied to the mesh without substantially altering a porosity of the mesh; the first layer comprises a first polymer and the second layer comprises a second polymer different than the first polymer; at least one of the polymers comprises a tyrosine-derived polyarylate.
Porosity-preserving two-layer mesh with water-soluble drug in first layer and tyrosine-derived polyarylate in second layer
A medical prosthesis comprising a surgical mesh with a coating including a first layer and a second layer, the first layer positioned between the mesh and the second layer; the first layer comprising a water soluble polymer and the second layer comprising a non-water soluble polymer; the coating applied to the mesh without substantially altering a porosity of the mesh; the first layer comprises a water soluble drug dissolved in the water soluble polymer; the non-water soluble polymer comprises a tyrosine-derived polyarylate.
Porosity-preserving two-layer mesh with tyrosine-derived polyarylate and rifampin/minocycline mixture in coating
A medical prosthesis comprising a surgical mesh with a coating including a first layer and a second layer, the first layer positioned between the mesh and the second layer; the coating applied to the mesh without substantially altering a porosity of the mesh; the first layer comprises a first polymer and the second layer comprises a second polymer different than the first polymer; at least one of the polymers comprises a tyrosine-derived polyarylate and a mixture of rifampin and minocycline.
Across the independent claims, the core claim coverage is a two-layer coating on a porous surgical mesh with the first layer interposed between the mesh and a second polymer layer, where coating application does not substantially alter porosity. The claims require different polymers between layers and require tyrosine-derived polyarylate in at least one polymer, with additional independent limitations specifying either a water-soluble drug dissolved in a water-soluble first layer or a rifampin and minocycline mixture.
Stated Advantages
Increases stiffness for easier handling while preserving the porosity of the surgical mesh.
Allows the mesh to revert toward original flexibility after degradation of coating components.
Enables drug localization/retention associated with coating at filament contact points and knots of woven meshes.
Documented Applications
Soft-tissue repair using temporarily stiffened porous surgical mesh prostheses.
Antimicrobial use with coatings that provide inhibition zones against Staphylococcus aureus and Staphylococcus epidermidis.
Local anesthesia/analgesia use with bupivacaine coatings described in terms of cumulative release profiles and rat dermal anesthesia behavior.
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