Implantable sensor with biocompatible coating for controlling or inhibiting tissue growth

• US 8,696,564 B2
• Filed: 07/09/2004
• Issued: 04/15/2014
• Est. Priority Date: 07/09/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Chavan, Abhi, Ross, Jeffrey, Morrissey, Cynthia, Mazar, Scott, Palme, Donald
• Primary Examiner(s): DAVIS, RUTH A
• Application Number:
  US10/888,340
• Publication Number:
  US 20060008500A1
• Time in Patent Office: 3,567 Days
• Field of Search: 424/423, 600/300, 600/310
• US Class Current: 600/300
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites

Abstract

All or a portion of a surface of an implantable sensor is covered with a biocompatible coating formed at least partially of a biomaterial matrix having properties that promote a substantially even growth of tissue cells over the surface of the coating. Additional materials, such as growth factors, agents that recruit endogenous stem cells, and cell adhesion motif arginine, glycine, aspartic acid may be included in the coating. Autologous cells may be added to the coating prior to implantation. The sensor surface may also be textured, by etching or abrading, in order to promote even tissue growth. Alternatively, the sensor surface may be covered with a coating having properties that inhibit the growth of tissue. These coatings may include a biomaterial, a biomaterial matrix having a drug, such as a sirolimus or a steroid, an active component, or a self assembled monolayer.

Claims

1. A sensor comprising:

a sensor having a sensor body, a sensor interface and a data transmission interface, each having a surface; and

a biocompatible coating covering at least the surface of the sensor interface, the coating comprising a biomaterial matrix and an active component, wherein the active component imparts properties to the coating that inhibits the growth of tissue over the sensor interface.

2. The sensor of claim 1 wherein the biomaterial matrix comprises a natural polymer.

3. The sensor of claim 2 wherein the natural polymer comprises extracellular matrix material.

4. The sensor of claim 3 wherein the extracellular matrix material is a material selected from the group consisting of intestine submucosa and urinary bladder matrix.

5. The sensor of claim 2 wherein the natural polymer comprises a protein.

6. The sensor of claim 5 wherein the protein is selected from the group consisting of collagen, fibrin, elastin, fibrillin, fibronectin, and laminin.

7. The sensor of claim 5 wherein the natural polymer comprises proteoglycans.

8. The sensor of claim 5 wherein the natural polymer comprises phosphytidyl choline.

9. The sensor of claim 1 wherein the biomaterial matrix comprises a synthetic polymer.

10. The sensor of claim 9 wherein the synthetic polymer is selected from the group consisting of polyhydroxyvalerate, poly(L)lactic acid, polycaprolactone, polylactide-co-glycolide, polyhydroxybutyrate, polyhydroxybutyrate-co-valerate, polydioxanone, polyorthoesters, polyanhydrides, polyacetic, polyglycolic acid, poly(D,L)lactic acid, polyglycolic acid-co-trimethylene carbonate, polysebacic acid, polylactic-co-sebacic acid, polyglycolic-co-sebacid acid, polyphosphoesters, polyphosphoester urethanes, polyamino acids, ion exchange resins, cyanoacrylates, polytrimethylene carbonate, polyiminocarbonate, copolyether-esters, polyalkylene oxalates and polyphosphazenes.

11. The sensor of claim 9 wherein the synthetic polymer is selected from the group consisting of polyurethanes, silicones and polyesters.

12. The sensor of claim 9 wherein the synthetic polymer is selected from the group consisting of polyolefin, polyisobutylene, ethylene-alphaolefin copolymers, acrylic polymers and copolymers, vinyl halide polymers and copolymers, polyvinyl ethers, polyvinylidene halides, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, polyvinyl esters, copolymers of vinyl monomers with each other and olefins, polyamides, alkyd resins, polycarbonates, polyoxymethylenes, polyimides, polyethers, epoxy resins, rayon and rayon-triacetate.

13. The sensor of claim 1 wherein the active component comprises a sirolimus.

14. The sensor of claim 1 wherein the active component comprises a steroid.

15. The sensor of claim 1 wherein the active component comprises at least one anti-thrombotic substance and at least one anti-inflammatory substance.

16. The sensor of claim 15 wherein the anti-thrombotic substance is selected from a group of heparin, sodium heparin, low molecular weight heparin, hirudin, argatroban, forskolin, vapiprost, prostacyclin and prostacyclin analogs, D-phe-pro-arg-chloromethylketone, dipyridamole, glycoprotein IIb/IIIa platelet membrane receptor antibody, and recombinant hirudin;

and the anti-inflamatory substance is selected from a group of aspirin, diclofenac, etodolac, ibuprofen, ketoprofen, ketorolac, nabumetone, naproxen, oxaprozin, clobetasol, diflucortolone, flucinolone, halcinolonide, halobetasol, dexamethasone, betamethasone, corticol, cortisone, prednisone, and prednisolone.

17. The sensor of claim 1 wherein the sensor body has a surface and the sensor interface protrudes or projects from the surface of the sensor body.

18. The sensor of claim 1 wherein the sensor interface is recessed within the sensor body.

19. The sensor of claim 1 wherein the sensor interface comprises a transmission device configured to transmit data gathered by the sensor.

20. The sensor of claim 1 wherein the sensor body has a body surface, the sensor interface has an interface surface, and the biocompatible coating covers portions of the body surface and the interface surface.

21. The sensor of claim 1 wherein the interface allows for the transmission of infra-red light.

22. A sensor comprising:

a pressure sensor having a sensor body, a sensor interface and a data transmission interface, each having a surface; and

a biocompatible coating on the surface of the sensor interface comprising biomaterial matrix and an agent that inhibits the growth of tissue over the surface of the sensor interface.

23. The sensor of claim 22 wherein the agent comprises polytetrafluoroethylene or polyethylene glycol.

24. The sensor of claim 22 wherein the agent comprises a steroid or sirolimus.

25. The sensor of claim 22 wherein the sensor interface comprises a pressure diaphragm.

26. A method of monitoring biological activity within a body, said method comprising introducing a sensor in the body in the region to be monitored, wherein the sensor comprises a sensor body, a sensor interface and a data transmission interface, each having a surface, and a biocompatible coating covering at least the surface of the sensor interface, the coating comprising a biomaterial matrix and an active component, wherein the active component imparts properties to the coating that inhibit the growth of tissue over the surface of the coating.

27. A process of manufacturing a sensor comprising a sensor body, a sensor interface and a data transmission interface, each having a surface, for implantation into a body, said process comprising coating at least the surface of the sensor interface with a biocompatible coating comprising a biomaterial matrix and an active component, wherein the active component imparts properties to the coating that inhibit the growth of tissue cells over the surface of the coating.