Controlled release matrix barrier structure for subcutaneous medical devices
View Patent ↗A biocompatible polymeric controlled release matrix barrier structure for delivery of one or more bioactive agents from an implantable medical device is described. In an embodiment, a biocompatible polymeric controlled release matrix barrier structure is included. The biocompatible polymeric controlled release matrix can include a body structure formed of a compliant material comprising one or more compliant biocompatible polymers and one or more bioactive agents. The body structure can define a central aperture through which a subcutaneous element of an implantable medical device passes. Other embodiments are included herein.
1. A biocompatible polymeric controlled release matrix barrier structure comprising:
a body structure formed of a compliant material comprising one or more compliant biocompatible polymers and one or more bioactive agents; and
the body structure defining a central aperture through which a subcutaneous element of an implantable medical device passes;
wherein the body structure further comprises an inner surface adjacent the central aperture, wherein the inner surface is circumferentially continuous; and at least a first poly(D,L-lactide-co-glycolide-co-ε-caprolactone) terpolymer disposed on the inner surface;
wherein the controlled release matrix barrier structure further comprises a central projection that is disposed about the central aperture at a top portion of the body structure and a flange disposed around the central projection, the flange having an outer surface with one or more suture loops disposed thereon; and
wherein the central projection extends in a direction away from the body structure.
2. The biocompatible polymeric controlled release matrix barrier structure of claim 1 , wherein the biocompatible polymer is biostable or biodegradable.
3. The biocompatible polymeric controlled release matrix barrier structure of claim 1 , wherein the controlled release matrix barrier structure comprises a polymer selected from the group consisting of: polycaprolactone (PCL), poly(lactic acid), poly(lactic-co-glycolic acid), and poly(ethylene-co-vinyl acetate).
4. The biocompatible polymeric controlled release matrix barrier structure of claim 3 , wherein the polymers are not cross-linked.
5. The biocompatible polymeric controlled release matrix barrier structure of claim 1 , wherein the bioactive agent is selected from the group consisting of antibiotics and antiseptics.
6. A biocompatible polymeric controlled release matrix barrier structure comprising:
a body structure comprising an elastomeric collar comprising one or more elastomeric biocompatible polymers and one or more bioactive agents;
the body structure defining a central aperture through which a subcutaneous element of an implantable medical device passes;
wherein the body structure further comprises an inner surface adjacent the central aperture, wherein the inner surface is circumferentially continuous; and at least a first poly(D,L-lactide-co-glycolide-co-ε-caprolactone) terpolymer exhibiting adhesive properties disposed on the inner surface;
wherein the controlled release matrix barrier structure further comprises a central projection that is disposed about the central aperture at a top portion of the body structure and a flange disposed around the central projection, the flange having an outer surface with one or more suture loops disposed thereon; and
wherein the central projection extends in a direction away from e body structure.
7. The biocompatible polymeric controlled release matrix barrier structure of claim 6 , wherein the biocompatible polymer is biostable or biodegradable.
8. The biocompatible polymeric controlled release matrix barrier structure of claim 6 , wherein the controlled release matrix barrier structure comprises a polymer selected from the group consisting of: polycaprolactone (PCL), poly(lactic acid), poly(lactic-co-glycolic acid), and poly(ethylene-co-vinyl acetate).
9. The biocompatible polymeric controlled release matrix barrier structure of claim 6 , wherein the polymers are not cross-linked.
10. The biocompatible polymeric controlled release matrix barrier structure of claim 6 , wherein the bioactive agent is selected from the group consisting of antibiotics and antiseptics.
11. The biocompatible polymeric controlled release matrix barrier structure of claim 1 , wherein the poly(D,L-lactide-co-glycolide-co-ε-caprolactone) has a molecular weight from 75,000 to 250,000 Daltons and a polydispersity index (PDI) of less than 2.0.
12. The biocompatible polymeric controlled release matrix barrier structure of claim 6 , wherein the poly(D,L-lactide-co-glycolide-co-ε-caprolactone) of has a molecular weight from 75,000 to 250,000 Daltons and a polydispersity index (PDI) of less than 2.0.
13. The biocompatible polymeric controlled release matrix barrier structure of claim 1 , the body structure further comprising a second poly(D,L-lactide-co-glycolide-co-ε-caprolactone).
14. The biocompatible polymeric controlled release matrix barrier structure of claim 13 , the second poly(DI-lactide-co-glycolide-co-ε-caprolactone) having a molecular weight from 130,000 Daltons or less and a polydispersity index (PDI) of less than 2.0, and wherein the molecular weight of the second poly(D,L-lactide-co-glycolide-co-ε-caprolactone) is less than the molecular weight of the first poly(D,L-lactide-co-glycolide-co-ε-caprolactone).