ANALYTE MEASURING DEVICE

• US 20080228054A1
• Filed: 02/26/2008
• Published: 09/18/2008
• Est. Priority Date: 03/04/1997
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Shults, Mark C., Brauker, James H., Carr-Brendel, Victoria, Updike, Stuart J., Markovic, Dubravka, Tapsak, Mark A., Rhodes, Rathbun K.
• Application Number:
  US12/037,830
• Publication Number:
  US 20080228054A1
• Time in Patent Office: Days
• US Class Current: 600/347
• 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
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• 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: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

An implantable analyte-measuring device including a membrane adapted to promote vascularization and/or interfere with barrier cell layer formation. The membrane includes any combination of materials, architecture, and bioactive agents that facilitate analyte transport to provide long-term in vivo performance of the implantable analyte-measuring device.

Claims

1. A device for subcutaneous monitoring of glucose levels, comprising a housing and a sensor, the sensor comprising an angiogenic layer for promoting adequate microcirculatory delivery of glucose and oxygen to the sensor, wherein the angiogenic layer further comprises a bioactive agent.

2. The device of claim 1, wherein the device is sized and configured for wholly subcutaneous implantation.

3. The device of claim 1, wherein the angiogenic layer comprises a material selected from the group consisting of hydrophilic polyvinylidene fluoride, mixed cellulose esters, polyvinyl chloride, polyvinyl alcohol, polyethylene, polytetrafluoroethylene, cellulose acetate, cellulose nitrate, polycarbonate, nylon, polyester, mixed esters of cellulose polyvinylidene difluoride, silicone, polyacrylonitrile, polypropylene, polysulfone, polymethacrylate, and mixtures thereof

4. The device of claim 3, wherein the angiogenic layer comprises expanded polytetrafluoroethylene.

5. The device of claim 3, wherein the angiogenic layer comprises silicone.

6. The device of claim 1, wherein the bioactive agent is selected from the group consisting of anti-inflammatory agents, anti-infective agents, anesthetics, inflammatory agents, growth factors, immunosuppressive agents, antiplatelet agents, anticoagulants, ACE inhibitors, cytotoxic agents, anti-barrier cell compounds, vascularization-inducing compounds, anti-sense molecules, and mixtures thereof

7. The device of claim 1, wherein the bioactive agent is incorporated within the angiogenic layer by at least one of:

absorption;

incorporation during formation of the angiogenic layer;

a microcapsule agent;

a carrier agent; and

using at least one substance selected from the group consisting of an ionic surfactant, a nonionic surfactant, a detergent, an emulsifier, a demulsifier, a stabilizer, an aqueous carrier, an oleaginous carrier, a solvent, a preservative, an antioxidant, a buffering agent, and mixtures thereof

8. The device of claim 1, wherein the angiogenic layer comprises a plurality of pores and wherein the bioactive agent is contained within the pores of the angiogenic layer.

9. The device of claim 1, the sensor further comprising a membrane impregnated with an oxidase.

10. The device of claim 9, wherein the membrane comprises a resistance layer with an oxygen-to-glucose permeability ratio of at least about 100:

1.

11. The device of claim 1, wherein the housing comprises an electronic circuit at least one electrode operatively connected to the electronic circuit, and a data transmitting apparatus operatively connected to the electronic circuit for transmitting data to a location external to the device using radiotelemetry.

12. The device of claim 1, wherein the sensor is located at an apex of the housing.

13. The device of claim 1, wherein the sensor comprises a dome configuration on at least a portion thereof

14. A device for subcutaneous monitoring of glucose levels, comprising a housing and a sensor, the sensor comprising an angiogenic layer for promoting adequate microcirculatory delivery of glucose and oxygen to the sensor, wherein the angiogenic layer further comprises an anesthetic.

15. The device of claim 14, wherein the anesthetic is selected from the group consisting of ethanol, bupivacaine, chloroprocaine, levobupivacaine, lidocaine, mepivacaine, procaine, ropivacaine, tetracaine, desflurane, isoflurane, ketamine, propofol, sevoflurane, codeine, fentanyl, hydromorphone, marcaine, meperidine, methadone, morphine, oxycodone, remifentanil, sufentanil, butorphanol, nalbuphine, tramadol, benzocaine, dibucaine, ethyl chloride, xylocalne, phenazopyridine, and mixtures thereof.