Medical device for glucose monitoring or regulation

• US 8,382,700 B2
• Filed: 10/22/2008
• Issued: 02/26/2013
• Est. Priority Date: 10/23/2007
• Status: Active Grant

• Current Assignee: Sensile Medical AG (Gerresheimer AG)
• Original Assignee: Sensile Pat Ag
• Inventors: Straessler, Sigfrid, Beyer, Uwe
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/681,904
• Publication Number:
  US 20100234830A1
• Time in Patent Office: 1,588 Days
• Field of Search: 604/504, 604/505, 604 65- 67, 604/890.1, 604/891.1, 210/96.2, 210/500.21
• US Class Current: 604/65
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A medical device comprising a pressure generating means adapted to deliver a liquid, a sensor adapted to measure a flow resistance, and an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the solution surrounding the implantable member. The analyte may in particular be glucose. The medical device may also be used for drug administration.

Claims

1. A medical device comprising:

an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the medium surrounding the implantable member;

a pressure generating means configured to deliver a liquid to the analyte responsive porous membrane; and

a sensor adapted to measure a flow resistance of said liquid through the analyte responsive porous membrane.

2. The medical device according to claim 1, wherein the pressure generating means delivers liquid in a succession of discrete amounts towards the glucose responsive porous membrane.

8. The medical device according to claim 1, wherein the implantable member comprises a valve (14) positioned proximate a free end of the implantable member.

10. The medical device according to claim 1, wherein the analyte is glucose and the liquid contains a drug capable of regulating blood glucose level in a patient.

11. The medical device according to claim 1, wherein the analyte is glucose and the porous membrane comprises a glucose responsive hydrogel selected from the group consisting of glucose-oxidase, lectin, and phenylboronic acid based hydrogels.

3. A medical device comprising:

an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the medium surrounding the implantable member;

a pressure generating means configured to deliver a liquid to the analyte responsive porous membrane; and

a sensor adapted to measure a flow resistance of said liquid through the analyte responsive porous membrane, wherein the sensor comprises a flexible membrane that is displaced upon liquid delivery, and a decay behavior of the flexible membrane is used to determine the flow resistance.

4. A medical device comprising:

an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the medium surrounding the implantable member;

a pressure generating means configured to deliver a liquid to the analyte responsive porous membrane;

a sensor adapted to measure a flow resistance of said liquid through the analyte responsive porous membrane;

a disposable unit (36) and a reusable unit (38), the disposable unit comprising the implantable member (4), a portion (3a) of a flow resistance sensor (3), a liquid medicine reservoir (20) and a portion (22a) of a pump (22), and the reusable unit comprising a signal processing circuit, a power supply, a complementary portion (3b) of said flow resistance sensor, and a complementary portion (22b) of said pump.

5. A medical device comprising:

an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the medium surrounding the implantable member;

a pressure generating means configured to deliver a liquid to the analyte responsive porous membrane; and

a sensor adapted to measure a flow resistance of said liquid through the analyte responsive porous membrane, wherein the implantable member comprises a support tube (9) with holes (8) filled or lined with the analyte responsive porous membrane (28, 28′

).

6. The medical device according to claim 5, wherein the analyte responsive porous membrane (28′

) is in the form of a tube inserted in the support tube (9).

7. The medical device according to claim 6, wherein the analyte responsive porous membrane comprises a porous substrate incorporating an analyte responsive hydrogel.

9. A medical device comprising:

an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the medium surrounding the implantable member;

a pressure generating means configured to deliver a liquid to the analyte responsive porous membrane; and

a sensor adapted to measure a flow resistance of said liquid through the analyte responsive porous membrane, wherein the implantable member comprises a valve (14) positioned proximate a free end of the implantable member, the valve comprising a pressure valve made of opposed abutting elastic protuberances.

12. A method of operating a medical device comprising an analyte responsive porous membrane which changes its porosity subject to changes in an analyte concentration occurring in a solution surrounding the analyte responsive porous membrane, comprising:

pumping a liquid in one or more discrete pre-determined volumes towards the analyte responsive porous membrane;

measuring a flow resistance of the liquid through the analyte responsive porous membrane; and

determining an analyte concentration based on the measured flow resistance.

13. The method according to claim 12, further including a calibration step comprising rinsing the analyte responsive porous membrane by pumping said liquid through the porous membrane and subsequently measuring a flow resistance of the liquid through the porous membrane.

14. The method according to claim 12, wherein the flow resistance is measured by a sensor comprising a flexible membrane that is displaced upon pumping the liquid, whereby a decay behavior of the flexible membrane is measured to determine a flow resistance.

15. The method according to claim 12, wherein the analyte is glucose and the analyte responsive porous membrane comprises a glucose responsive hydrogel selected from the group consisting of glucose-oxidase, lectin, and phenylboronic acid based hydrogels.

16. A method of measuring an analyte concentration, the method comprising:

providing a medical device comprising an analyte responsive porous membrane which changes its porosity subject to changes in analyte concentration occurring in a solution surrounding the analyte responsive porous membrane;

delivering a liquid in one or more discrete pre-determined volumes towards the analyte responsive porous membrane;

measuring a flow resistance of the liquid through the analyte responsive porous membrane; and

determining an analyte concentration based on the measured flow resistance.

17. The method according to claim 16, further including a calibration step comprising rinsing the analyte responsive porous membrane by pumping said liquid through the analyte responsive porous membrane and subsequently measuring a flow resistance of the liquid through the glucose responsive porous membrane.

18. The method according to claim 17, wherein the flow resistance is measured by a sensor comprising a flexible membrane that is displaced upon liquid delivery, whereby a decay behavior of the flexible membrane is used to determine a flow resistance.

19. The method according to claim 16, wherein the analyte is glucose and the glucose responsive porous membrane comprises a glucose responsive hydrogel selected from the group consisting of glucose-oxidase, lectin, and phenylboronic acid based hydrogels.

20. The method according to claim 16, wherein said analyte is glucose said method further comprising delivering a drug capable of influencing an glucose levels in a patient according to the measured glucose concentration in said patient that has been determined based on the measured flow resistance of said liquid.

21. The method according to claim 20, wherein the drug is delivered through a valve comprised in the implantable member.

22. The method according to claim 20, wherein a glucose responsive porous membrane is used to measure flow resistance of said liquid.

23. The method according to claim 22, wherein a basal rate of the drug is delivered through the glucose responsive porous membrane and a bolus rate of the drug is delivered through a valve.

24. The method according to claim 20, wherein the drug is delivered through a separate second implantable member or through a separated lumen within the implantable member.

25. The method according to claim 22, further including a patient interaction step comprising providing information on blood glucose level to the patient and receiving an instruction by the patient related to the delivery of the drug.

26. The method according to claim 22, wherein the delivered drug is any one or more of a substance capable of influencing blood glucose concentration, selected from the group consisting of insulin, glucagons, and amylin.