Anchorage devices comprising an active pharmaceutical ingredient

• US 10,086,115 B2
• Filed: 10/04/2013
• Issued: 10/02/2018
• Est. Priority Date: 11/12/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: TYRX, INC. (Medtronic Plc)
• Inventors: McJames, William, Do, Frank, Pulapura, Satish, Ge, Qing
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US14/045,991
• Publication Number:
  US 20140031912A1
• Time in Patent Office: 1,824 Days
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61N 1/059 Anchoring means

Abstract

An anchorage device comprising a mesh substrate coupled to an implantable medical device is disclosed, where the mesh substrate has a coating comprising a polymer, and the mesh further comprises at least one active pharmaceutical ingredient. The active pharmaceutical agent is designed to elute from the mesh over time. The mesh substrate can be configured to reduce the mass of the anchorage device such that tissue in-growth and/or scar tissue formation at the treatment site is reduced. In some embodiments, the mesh substrate can be formed with a mesh having a low areal density. In some embodiments, the mesh substrate can include one or more apertures or pores to reduce the mass of the substrate.

Claims

1. A device comprising a non-porous first sheet and a second sheet including a mesh substrate, said sheets being joined to define a pocket, said mesh substrate first being coated with a polymer comprising at least one active pharmaceutical ingredient and then being coated with a hemostatic agent, said mesh substrate comprising a matrix of filaments, said filaments defining pores therebetween, said pores ranging in size between about 5 mm and about 10 mm, said mesh substrate comprising an aperture having a size that is larger than that of the pores, wherein a shunt is positioned in said pocket.

2. The device of claim 1, wherein said active pharmaceutical ingredient is selected from the group consisting of anesthetics, antibiotics, anti-inflammatory agents, procoagulant agents, fibrosis-inhibiting agents, antiscarring agents, leukotriene inhibitors/antagonists, cell growth inhibitors and mixtures thereof.

3. The device of claim 1, wherein said active pharmaceutical ingredient is an antibiotic.

4. The device of claim 3, wherein said antibiotic is selected from the group consisting of rifampin, minocycline, and mixtures thereof.

5. The device of claim 1, wherein said polymer is selected from the group consisting of polylactic acid, polyglycolic acid, poly(L-lactide), poly(D,L-lactide) polyglycolic acid[polyglycolide], poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D,L-lactide-co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(D,L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), polyethylene oxide, polydioxanone, polypropylene fumarate, poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxycarbonylmethyl glutamate), polycaprolactone, polycaprolactone co-butylacrylate, polyhydroxybutyrate, copolymers of polyhydroxybutyrate, poly(phosphazene), poly(phosphate ester), poly(amino acid), polydepsipeptides, maleic anhydride copolymers, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)], poly(orthoesters), tyrosine-derived polyarylates, tyrosine-derived polycarbonates, tyrosine-derived polyiminocarbonates, tyrosine-derived polyphosphonates, polyethylene oxide, polyethylene glycol, polyalkylene oxides, hydroxypropylmethylcellulose, polysaccharides such as hyaluronic acid, chitosan and regenerate cellulose.

6. The device of claim 1, wherein said polymer is a polyarylate.

7. The device of claim 1, wherein said polymer is a member of the P22-xx family.

8. The device of claim 1, wherein said mesh has a low areal density and said aperture comprises a plurality of apertures to reduce a mass of said device.

9. The device of claim 1, wherein said coating has a thickness ranging from about 5pm to about 200pm.

10. A method of preventing, mitigating, or treating a bacterial infection comprising implanting the device of claim 1.

11. The device of claim 1, wherein said mesh substrate is knitted so as to allow said mesh substrate to be separated from said shunt by unraveling a filament of said mesh substrate.

12. The device of claim 1, wherein said aperture is present in said device before said device is implanted, said shunt being removable from said device through said aperture.

13. The device of claim 1, wherein said mesh substrate is formed with a flexible shape-memory material configured to move between a collapsed configuration and an expanded configuration, said mesh substrate being biased to the collapsed configuration.

14. The device of claim 1, wherein said device is configured to decrease in stiffness after said device is implanted in a patient.

15. The device of claim 1, wherein said coating covers or fills said pores and said aperture.

16. A device comprising a non-porous first sheet and a second sheet including a mesh substrate, said mesh substrate having a coating comprising a first layer that is applied directly to said mesh substrate and a second layer that is applied directly to said first layer, said first layer comprising a polymer and at least one active pharmaceutical ingredient, said second layer comprising a hemostatic agent, said mesh substrate comprising a matrix of filaments, said filaments defining pores therebetween, said pores ranging in size between about 5 mm and about 10 mm, said mesh substrate comprising an aperture having a size that is larger than that of the pores, wherein shunt is positioned between said sheets.

17. The device of claim 16, wherein said hemostatic agent is selected from the group consisting of oxidized regenerated cellulose, chitosan, and a gel foam.

18. The device of claim 16, wherein only one side of said mesh substrate is coated with said coating.

19. The device of claim 18, wherein said other side of said mesh substrate is coated only with a second coating, said second coating comprising said polymer and said at least one active pharmaceutical ingredient, wherein said polymer is a tyrosine-derived polyarylate.

20. An anchorage device comprising a non-porous first sheet and a second sheet including a mesh substrate, the sheets being joined along portions of perimeters of the sheets to define a pocket, the mesh substrate being coated with a coating comprising a first layer that is applied directly to the mesh substrate and a second layer that is applied directly to the first layer, the first layer comprising a biodegradable polymer and an active pharmaceutical ingredient, the polymer being configured to release the active pharmaceutical ingredient over time as the polymer degrades, the second layer comprising a hemostatic agent, wherein a shunt is positioned in said pocket.

21. The anchorage device of claim 20, wherein the hemostatic agent is selected from a group comprising oxidized regenerated cellulose and chitosan.

22. The anchorage device of claim 20, wherein the active pharmaceutical ingredient is selected from a group consisting of rifampin, minocycline, and mixtures thereof.

23. The anchorage device of claim 20, wherein the polymer is a member of the P22-xx family.

24. The anchorage device of claim 20, wherein the second layer consists of the hemostatic agent.

25. The anchorage device of claim 20, wherein the first layer is free of hemostatic agents.

26. The anchorage device of claim 20, wherein the first layer is free of hemostatic agents and the second layer consists of the hemostatic agent.