Mesh pouches for implantable medical devices
First Claim
1. A mesh pouch prophylactically encasing at least about 75% of the surface of a medical device in said mesh pouch for implantation in the body, said mesh pouch comprising a porous surgical mesh which is sufficiently porous to permit said medical device to be electrically grounded to surrounding tissue and which permits tissue ingrowth into said mesh pouch which stabilizes said medical device within said mesh pouch, said porous surgical mesh including one or more biodegradable and resorbable synthetic polymer coatings which have been applied to said porous surgical mesh without substantially altering the porosity of said surgical mesh, whereby the stiffness of said surgical mesh is increased to facilitate said implantation, but decreases subsequent to said implantation.
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Accused Products
Abstract
Biodegradable polymer-coated surgical meshes formed into pouches are described for use with cardiac rhythm management devices (CRMs) and other implantable medical devices. Such meshes are formed into a receptacle, e.g., a pouch or other covering, capable of encasing, surrounding and/or holding the cardiac rhythm management device or other implantable medical device for the purpose of securing it in position, inhibiting or reducing bacterial growth, providing pain relief and/or inhibiting scarring or fibrosis on or around the CRM or other implantable medical device. Preferred embodiments include surgical mesh pouches 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 pouches of the invention can also provide relief from various post-operative complications associated with their implantation, insertion or surgical use, and, optionally, include one or more drugs in the polymer matrix of the coating to provide prophylactic effects and/or alleviate side effects or complications associated with the surgery or implantation of the CRM or other implantable medical device.
187 Citations
37 Claims
- 1. A mesh pouch prophylactically encasing at least about 75% of the surface of a medical device in said mesh pouch for implantation in the body, said mesh pouch comprising a porous surgical mesh which is sufficiently porous to permit said medical device to be electrically grounded to surrounding tissue and which permits tissue ingrowth into said mesh pouch which stabilizes said medical device within said mesh pouch, said porous surgical mesh including one or more biodegradable and resorbable synthetic polymer coatings which have been applied to said porous surgical mesh without substantially altering the porosity of said surgical mesh, whereby the stiffness of said surgical mesh is increased to facilitate said implantation, but decreases subsequent to said implantation.
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24. A mesh pouch having a shape comprising a bottom, two sides and a top and a front and a back, and an overall size including a height of between about 1.5-2.56″
- , a length of between about 1.63-2.4″ and
a width of from about 0.24-0.6″ and
wherein said front and back surfaces are sealed to each other over at least said bottom and sides for prophylactically encasing and fitting an implantable medical device for implantation in the body, said mesh pouch comprising a porous surgical mesh which permits tissue ingrowth into said mesh which stabilizes said implantable medical device within said porous surgical mesh, and including one or more biodegradable and resorbable synthetic polymer coatings applied to said porous surgical mesh without substantially altering the porosity of said porous surgical mesh, whereby the stiffness of said surgical mesh is increased to facilitate said implantation, but decreases subsequent to said implantation, said synthetic polymer coating including one or more drugs. - View Dependent Claims (25, 26, 27)
- , a length of between about 1.63-2.4″ and
- 28. A mesh pouch for implantation in the body, said mesh pouch having a shape for encasing a medical device and comprising a porous non-resorbable surgical mesh with a coating comprising (1) a biodegradable and resorbable polymer comprising a polyarylate comprising desaminotyrosyl-tyrosine (DT)-desaminotyrosyl-tyrosyl ester (DTE) succinate having from about 1% DT to about 30% DT and (2) a drug comprising an antimicrobial agent comprising rifampin and minocycline, which coating has been applied to said surgical mesh without substantially altering the porosity of said surgical mesh, whereby the stiffness of said surgical mesh is increased to facilitate said implantation, but decreases subsequent to said implantation.
- 30. A mesh pouch prophylactically encasing at least about 75% of the surface of a medical device in said mesh pouch for implantation in the body, said mesh pouch comprising a porous non-resorbable surgical mesh which is sufficiently porous to permit said medical device to be electrically grounded to surrounding tissue, said porous surgical mesh including one or more biodegradable and resorbable synthetic polymer coatings which have been applied to said porous surgical mesh without substantially altering the porosity of said surgical mesh, whereby the stiffness of said surgical mesh is increased to facilitate said implantation, but decreases subsequent to said implantation, wherein at least one of said biodegradable polymers comprises one or more tyrosine-derived diphenyl monomer units.
- 34. A mesh pouch for implantation in the body, said mesh pouch having a shape for encasing a medical device and comprising a porous surgical mesh with a coating comprising (1) a biodegradable and resorbable polymer comprising a polyarylate comprising desaminotyrosyl-tyrosine (DT)-desaminotyrosyl-tyrosyl ester (DTE) succinate having from about 1% DT to about 30% DT and (2) a drug comprising an antimicrobial agent or an anesthetic, which coating has been applied to said surgical mesh without substantially altering the porosity of said surgical mesh, whereby the stiffness of said surgical mesh is increased to facilitate said implantation, but decreases subsequent to said implantation.
Specification