ANALYTE MEASURING DEVICE

• US 20080228051A1
• Filed: 02/26/2008
• Published: 09/18/2008
• Est. Priority Date: 03/04/1997
• Status: Active Grant

• 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.
• Granted Patent: US 7,860,545 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• 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, a sensor, and a biointerface layer for promoting adequate microcirculatory delivery of glucose and oxygen to the sensor, wherein the biointerface layer is configured to maintain sufficient fluid flow to the sensor for glucose measurement thereby.

2. The device of claim 1, wherein the biointerface 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.

3. The device of claim 1, wherein the biointerface layer comprises expanded polytetrafluoroethylene.

4. The device of claim 1, wherein the biointerface layer comprises silicone.

5. The device of claim 1, further comprising a bioactive agent.

6. The device of claim 5, 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. 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 anti-inflammatory agent.

8. The device of claim 7, wherein the anti-inflammatory agent is selected from the group consisting of nonsteroidal anti-inflammatory drugs (NTHEs), aspirin, celecoxib, choline magnesium trisalicylate, diclofenac potassium, diclofenac sodium, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, melenamic acid, nabumetone, naproxen, naproxen sodium, oxaprozin, piroxicam, rofecoxib, salsalate, sulindac, tolmetin, corticosteroids, cortisone, hydrocortisone, methylprednisolone, prednisone, prednisolone, betamethesone, beclomethasone dipropionate, budesonide, dexamethasone sodium phosphate, flunisolide, fluticasone propionate, triamcinolone acetonide, betamethasone, fluocinolone, fluocinonide, betamethasone dipropionate, betamethasone valerate, desonide, desoximetasone, fluocinolone, triamcinolone, triamcinolone acetonide, clobetasol propionate, dexamethasone, and mixtures thereof.

9. 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 anti-infective agent.

10. The device of claim 9, wherein the anti-infective agent is selected from the group consisting of anthelmintics, mebendazole, antibiotics, aminoclycosides, gentamicin, neomycin, tobramycin, antifungal antibiotics, amphotericin b, fluconazole, griseofulvin, itraconazole, ketoconazole, nystatin, micatin, tolnaftate, cephalosporins, cefaclor, cefazolin, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, cephalexin, beta-lactam antibiotics, cefotetan, meropenem, chloramphenicol, macrolides, azithromycin, clarithromycin, erythromycin, penicillins penicillin G sodium salt, amoxicillin, ampicillin, dicloxacillin, nafcillin, piperacillin, ticarcillin, tetracyclines, doxycycline, minocycline, tetracycline, bacitracin, clindamycin, colistimethate sodium, polymyxin b sulfate, vancomycin;

antivirals including acyclovir, amantadine, didanosine, efavirenz, foscarnet, ganciclovir, indinavir, lamivudine, nelfinavir, ritonavir, saquinavir, stavudine, valacyclovir, valganciclovir, zidovudine, quinolones, ciprofloxacin, levofloxacin, sulfonamides, sulfadiazine, sulfisoxazole, sulfones, dapsone, furazolidone, metronidazole, pentamidine, sulfanilamidum crystallinum, gatifloxacin, sulfamethoxazole/trimethoprim, and mixtures thereof.