Systems and methods for sensing analyte and dispensing therapeutic fluid

Abstract

Systems and methods are provided for sensing analyte (e.g., glucose) and/or dispensing therapeutic fluid (e.g., insulin). The systems and methods are based on transporting the therapeutic fluid through a cannula at least a portion of which is permeable to molecule of the analyte. Sensing and detection of the concentration level of the analyte can be carried out by optical sensing, electrochemical sensing, acoustical sensing etc. Sensing and dispensing can be carried out by sensing and dispensing device operating in either closed or semi-closed loop.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the present invention, reference is made to the following description, taken in conjunction with the accompanying drawings, in which like reference numerals refer to like parts throughout, and in which:

FIG. 1 is a schematic drawing of a closed loop system, including a dispensing apparatus, a sensing apparatus and a processor-controller apparatus, with a single exit port;

FIG. 2 is a schematic drawing of a closed loop system, including a dispensing apparatus, a sensing apparatus and a processor-controller apparatus with multiple exit ports;

FIG. 3 illustrates an example of an embodiment according to the present invention;

FIGS. 4A and 4B illustrate an example of a penetrating member, cannula and well assembly;

FIG. 5A illustrates an example of the penetrating member and cannula of FIGS. 4A and 4B after insertion into the body, through the well assembly, according to one embodiment of the present invention;

FIG. 5B illustrates the embodiment of FIGS. 4A and 4B after removal of the penetrating member;

FIG. 6 illustrates sensing apparatus subassemblies according to embodiments of the present invention;

FIG. 7 illustrates sensing apparatus subassemblies, with a well assembly, according to embodiments of the present invention;

FIG. 8 illustrates a detailed view of a cannula according to an embodiment of the present invention;

FIG. 9 illustrates a cannula with an analyte-rich dialysate, and a sensing device, according to an embodiment of the invention;

FIG. 10 illustrates an example of a sensing apparatus using an optical sensing device according to an embodiment of the present invention;

FIG. 11 illustrates an example of a fully semi-permeable cannula according to an embodiment of the present invention;

FIG. 12 illustrates an example of a cannula comprising two separate materials, connected mechanically, according to an embodiment of the present invention; and

FIG. 13 is a drawing of a measurement cell and a glucose sensor according to an embodiment of the present invention in which electrochemical glucose oxidase based sensing is performed.

Claims

1. Apparatus for in vivo detection of an analyte, comprising: at least one housing;a cannula comprising a proximal portion located within the housing and a distal portion located external to the housing, wherein the distal portion is configured for subcutaneous placement within a mammal's body and at least a portion of said cannula is permeable to molecules of an analyte;a sensor configured to detect a concentration level of the analyte within the cannula; anda pump residing in the housing and adapted to transport a fluid to the cannula.

2. The apparatus of claim 1, wherein the analyte comprises glucose.

3. The apparatus of claim 1, wherein the sensor is located at least partially within the housing and is configured to detect the concentration level of the analyte within a proximal portion of the cannula.

4. The apparatus of claim 3, wherein the pump is configured to transport a perfusate fluid.

5. The apparatus of claim 4, wherein said perfusate fluid is selected from the group consisting of a therapeutic fluid, a non-therapeutic fluid and a combination thereof.

6. The apparatus of claim 4, wherein said perfusate fluid comprises insulin.

7. The apparatus of claim 4, wherein said perfusate fluid comprises saline.

8. The apparatus of claim 1, wherein the sensor is configured to detect a concentration level of the analyte at about, or subsequent to, the establishing of a concentration equilibrium between the analyte within the cannula and the analyte outside the cannula.

9. The apparatus of claim 1, wherein the sensor comprises an optical sensor.

10. The apparatus of claim 9, wherein the optical sensor is configured to detect the concentration level of the analyte based on an optical detection method selected from the group of optical detection methods consisting of near infra red (“NIR”) reflectance, mid infra red (“IR”) spectroscopy, light scattering, Raman scattering, fluourescence measurements, and a combination thereof.

11. The apparatus of claim 1, wherein the sensor is selected from the group consisting of an optical sensor, electrochemical sensor, acoustic sensor and a combination thereof.

12. The apparatus of claim 1, further comprising a memory capable of storing at least concentration levels detected by the sensor continuously or at predetermined intervals.

13. The apparatus of claim 1, wherein the housing comprises a patch that is cutaneously adherable to the mammal's body.

14. The apparatus of claim 1, wherein the distal portion of the cannula is configured for subcutaneous placement within a location of the mammal's body that provides access to interstitial fluid (“ISF”).

15. The apparatus of claim 1, wherein the distal portion of the cannula is configured for subcutaneous placement within a location of the mammal's body that provides access to blood.

16. The apparatus of claim 4, wherein the housing further comprises: a processor; anda reservoir for the perfusate fluid,wherein the pump is in fluid communication with the reservoir and in electrical communication with the processor, wherein the pump is configured to transport the perfusate fluid to the cannula in an amount based at least in part on a signal received from the processor.

17. The apparatus of claim 1, wherein the pump comprises a peristaltic pump.

18. Apparatus for in vivo detection of an analyte, comprising: a cannula comprising a proximal portion located within a housing and a distal portion located external to the housing, wherein the distal portion is configured for subcutaneous placement within a mammal's body and at least a portion of said cannula is permeable to molecules of an analyte; anda sensing means, which is configured to detect a concentration level of the analyte within the cannula.

19. Apparatus for in vivo detection of an analyte and delivery of a therapeutic fluid to the mammal's body, comprising: a housing comprising at least a sensor, a pump, a processor and a reservoir for the therapeutic fluid; anda cannula comprising a proximal portion located within the housing and a distal portion located external to the housing, wherein the distal portion is configured for subcutaneous placement within a mammal's body and at least a portion of said first cannula is permeable to molecules of an analyte;wherein the sensor is in communication with the processor and is configured to detect a concentration level of the analyte within the proximal portion of the cannula; andwherein the pump is in fluid communication with the reservoir and in electrical communication with the processor and is configured to deliver the therapeutic fluid to the mammal's body according to the detected concentration level.

20. The apparatus of claim 19, further comprising a second cannula which is in communication with the mammal's body, and wherein the pump is configured to deliver the therapeutic fluid to the mammal's body through the second cannula.

21. The apparatus of claim 19, wherein the sensor and the pump operate within a closed-loop configuration.

22. The apparatus of claim 19, wherein the sensor and the pump operate within a semi-closed loop configuration upon external input.

23. The apparatus of claim 19, wherein the housing comprises a patch that is cutaneously adherable to the mammal's body.

24. A method for in vivo detection of an analyte, comprising: providing a cannula at least a portion of which is permeable to molecules of an analyte;positioning the cannula at least partially subcutaneously within a mammal's body;transporting a fluid to the cannula; andsensing a concentration level of the analyte within the cannula at about, or subsequent to, establishing an equilibrium between a concentration level of the analyte within the cannula and a concentration level of the analyte outside the cannula.

25. The method of claim 24, wherein said fluid is a perfusate fluid.

26. The method of claim 25, wherein said perfusate fluid is selected from the group consisting of a therapeutic fluid, a non-therapeutic fluid and a combination thereof.

27. The method of claim 25, wherein said perfusate fluid comprises insulin.

28. The method of claim 25, wherein said perfusate fluid comprises saline.

29. The method of claim 25, wherein the analyte comprises glucose.

30. The method of claim 25, wherein the sensing of the concentration level is carried out within the proximal portion of the cannula and wherein the method further comprises transporting the analyte to the proximal portion of the cannula.

31. The method of claim 25, wherein the sensing is selected from the group consisting of optical sensing, electrochemical sensing, acoustical sensing, and a combination thereof.

32. A method for in vivo detection of an analyte and for delivery of a fluid to a mammal's body comprising providing a cannula at least a portion of which is permeable to molecules of the analyte;positioning the cannula at least partially subcutaneously within the mammal's body;transporting the fluid to the cannula;detecting a concentration level of the analyte within the cannula at about, or subsequent to, establishing an equilibrium between concentration level of the analyte within the cannula and concentration level of the analyte outside the cannula; anddelivering the fluid to the mammal's body in an amount based at least in part on the detected concentration level.

33. The method of claim 32, further comprising providing a second cannula, wherein the delivering of the fluid is carried out through the second cannula.

34. The method of claim 32, wherein said fluid is a perfusate fluid.

35. The method of claim 34, wherein said perfusate fluid is selected from the group consisting of a therapeutic fluid, a non-therapeutic fluid and a combination thereof.

36. The method of claim 35, wherein said therapeutic fluid comprises insulin.

37. The method of claim 34, wherein said perfusate fluid comprises saline.

38. The method of claim 32, wherein the analyte comprises glucose.

39. The method of claim 32, wherein the sensing of the concentration level of the analyte is carried out within the proximal portion of the cannula and wherein the method further comprises transporting the analyte to the proximal portion of the cannula.

40. The method of claim 32, wherein the sensing is selected from the group consisting of optical sensing, electrochemical sensing, acoustical sensing, and a combination thereof.