Implantable enzyme-based monitoring systems having improved longevity due to improved exterior surfaces

• US 6,477,395 B2
• Filed: 09/14/1999
• Issued: 11/05/2002
• Est. Priority Date: 10/20/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Schulman, Joseph H., Byers, Charles L., Adomian, Gerald E., Colvin, Michael S.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/395,434
• Publication Number:
  US 20010051768A1
• Time in Patent Office: 1,148 Days
• Field of Search: 600/345-365, 204/415
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

An implantable enzyme-based monitoring system suitable for long term in vivo use to measure the concentration of prescribed substances such as glucose is provided. In one embodiment, the implantable enzyme-based monitoring system includes at least one sensor assembly, an outer membrane surrounding the sensor assembly and having a window therein, and a polymeric window cover affixed to the outer membrane and covering the window. Preferably, the outer membrane of the monitoring system is silicone and the window cover is a polymer of 2-hydroxyethyl methacrylate (HEMA), N,N,-dimethylaminoethyl methacrylate (DMAEMA) and methacrylic acid (MA). Also provided herein is an implantable enzyme-based monitoring system having at least one sensor assembly, an outer membrane surrounding the sensor assembly and a coating affixed to the exterior surface of the outer membrane, wherein the coating resists blood coagulation and protein binding to the exterior surface of the outer membrane. Preferably, the coating is polyethylene glycol (PEG) and heparin in an 80:20 molar ratio. Finally, provided herein is a method of coating the exterior surface of the outer membrane of an implantable enzyme-based monitoring system comprising the steps of forming hydroxyl groups on the silicone surface by plasma etching; reacting the silicone surface with amino functionalized silane, thereby forming amino groups on the silicone surface; simultaneously, covalently binding polyethylene glycol (PEG) and heparin to the amino groups; and ionically binding heparin to the monitoring system surface.

Claims

1. An implantable monitoring system comprising:

a plurality of sensor assemblies, each sensor assembly having a sensing area for sensing a parameter of an implant environment;

a membrane having a longitudinal dimension, and a width dimension, with the longitudinal dimension being greater than the width dimension;

wherein the sensor assemblies are spaced along the longitudinal dimension of the membrane; and

wherein the sensing areas are rotationally displaced relative to the longitudinal dimension of the membrane.

2. An implantable monitoring system according to claim 1, wherein at least three sensing areas are facing three distinct directions.

3. An implantable monitoring system according to claim 1, wherein at least two sensing areas are rotationally displaced approximately 180 degrees relative to the longitudinal dimension of the membrane.

4. An implantable monitoring system according to claim 1, wherein the membrane is curved along the longitudinal dimension of the membrane.

5. An implantable monitoring system according to claim 4, wherein each sensing area is located on a concave portion of the membrane.

6. An implantable monitoring system according to claim 5, wherein the membrane is spiral along the longitudinal dimension of the membrane.

7. An implantable monitoring system according to claim 5, wherein the membrane is arcuate along the longitudinal dimension of the membrane.

8. An implantable monitoring system according to claim 5, wherein the membrane is S-shaped along the longitudinal dimension of the membrane.

9. An implantable monitoring system comprising:

a plurality of sensor assemblies, each sensor assembly having a sensing area for sensing a parameter of an implant environment;

a membrane having a longitudinal dimension, and a width dimension, with the longitudinal dimension being greater than the width dimension;

wherein the membrane is curved along the longitudinal dimension; and

wherein the sensor assemblies are disposed along the longitudinal dimension of the membrane.

10. An implantable monitoring system according to claim 9, wherein each sensing area is located on a concave portion of the membrane.

11. An implantable monitoring system according to claim 10, wherein the membrane is spiral along the longitudinal dimension of the membrane.

12. An implantable monitoring system according to claim 10, wherein the membrane is arcuate along the longitudinal dimension of the membrane.

13. An implantable monitoring system according to claim 10, wherein the membrane is S-shaped along the longitudinal dimension of the membrane.

14. An implantable monitoring system comprising:

three or more electrochemical sensor assemblies, each sensor assembly having a sensing area for sensing a parameter of an implant environment, wherein at least three of the sensing areas are facing three distinct directions.

15. An implantable monitoring system according to claim 14, further comprising a membrane with a longitudinal dimension, and a width dimension, with the longitudinal dimension being greater than the width dimension, wherein the sensor assemblies are spaced along the longitudinal dimension.

16. An implantable monitoring system according to claim 15, wherein the membrane is curved along the longitudinal dimension of the membrane.

17. An implantable monitoring system according to claim 16, wherein each sensing area is located on a concave portion of the membrane.

18. An implantable monitoring system according to claim 17, wherein the membrane is spiral along the longitudinal dimension of the membrane.

19. An implantable monitoring system according to claim 17, wherein the membrane is arcuate along the longitudinal dimension of the membrane.

20. An implantable monitoring system according to claim 17, wherein the membrane is S-shaped along the longitudinal dimension of the membrane.