Membrane for use with implantable devices

• US 10,039,480 B2
• Filed: 02/11/2015
• Issued: 08/07/2018
• Est. Priority Date: 07/27/2001
• Status: Expired due to Term

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Shults, Mark C., Tapsak, Mark A.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/619,651
• Publication Number:
  US 20150157248A1
• Time in Patent Office: 1,273 Days
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: Y10T 428/249921 Web or sheet containing structurally defined element or component

Abstract

The present invention provides a biointerface membrane for use with an implantable device that interferes with the formation of a barrier cell layer including; a first domain distal to the implantable device wherein the first domain supports tissue attachment and interferes with barrier cell layer formation and a second domain proximal to the implantable device wherein the second domain is resistant to cellular attachment and is impermeable to cells. In addition, the present invention provides sensors including the biointerface membrane, implantable devices including these sensors or biointerface membranes, and methods of monitoring glucose levels in a host utilizing the analyte detection implantable device of the invention. Other implantable devices which include the biointerface membrane of the present invention, such as devices for cell transplantation, drug delivery devices, and electrical signal delivery or measuring devices are also provided.

Claims

1. An implantable device for continuous measurement of a glucose concentration, comprising:

a sensing region configured to continuously measure a signal indicative of a glucose concentration in a host; and

a membrane system located over the sensing region, wherein the membrane comprises a sensing membrane and a biointerface membrane, wherein the sensing membrane comprises an enzyme configured to catalyze a reaction with glucose as a reactant, wherein the biointerface membrane is configured to resist cellular attachment and is impermeable to cells and cell processes.

2. The implantable device of claim 1, wherein the biointerface membrane comprises silicone.

3. The implantable device of claim 1, wherein the biointerface membrane comprises a polyurethane.

4. The implantable device of claim 3, wherein the polyurethane polymer is a copolymer.

5. The implantable device of claim 4, wherein the copolymer comprises silicone.

6. The implantable device of claim 1, wherein the biointerface membrane is configured to prevent with barrier-cell layer formation.

7. The implantable device of claim 1, wherein the membrane system is configured to facilitate obtaining of a level of accuracy corresponding to having, over a period of time exceeding 5 days, 90% of measured analyte values within an “

A”

region and a “

B”

region of a standard Clarke error grid when sensor measurements are compared to a standard reference measurement.

8. The implantable device of claim 1, wherein the membrane system has a thickness of from about 10 microns to about 100 microns.

9. The implantable device of claim 1, wherein the biointerface membrane is configured to provide an interface with a biological fluid.