Reciprocating delivery of fluids to the body with analyte concentration monitoring

• US 8,814,822 B2
• Filed: 05/07/2008
• Issued: 08/26/2014
• Est. Priority Date: 05/07/2007
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Kaidar, Ruthy, Shapira, Gali
• Primary Examiner(s): Vu, Quynh-Nhu H
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US12/116,546
• Publication Number:
  US 20080281290A1
• Time in Patent Office: 2,302 Days
• Field of Search: 604/27, 604/28, 604/31, 604/35, 604 65- 67, 604/500, 604/503, 604/890.1, 604/891.1
• US Class Current: 604/67
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• 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

Abstract

A volume of an analyte-enriched fluid can be withdrawn out of a user'"'"'s subcutaneous compartment using a patch unit that includes a reversible pumping mechanism. The volume can be withdrawn out of the body and into the patch unit through a cannula inserted into the subcutaneous compartment so that an analyte concentration in the volume can be measured using a sensing element within the patch unit. After analyte concentration analysis, at least the volume can be delivered back into the subcutaneous compartment by operating the pumping mechanism in a forward direction. biologically compatible fluid can optionally be pumped into the subcutaneous compartment from a reservoir in the patch unit and then allowed to partially or completely equilibrate with the analyte concentration in the interstitial fluid of the subcutaneous compartment via a permeable or semi-permeable cannula surface before being drawn back into the patch unit for analysis. Related systems, apparatus, methods, and/or articles are also described.

Claims

1. A method comprising:

delivering a volume of a therapeutic fluid from a reservoir in a patch unit into a subcutaneous compartment of a user via a first conduit and a cannula inserted within the subcutaneous compartment, the delivering occurring under the influence of a pumping mechanism in the patch unit that operates to displace the therapeutic fluid in a forward direction;

suspending delivery of the therapeutic fluid by setting the pumping mechanism in a substantially static state such that the therapeutic fluid achieves at least a partial analyte concentration equilibrium with interstitial fluids in the subcutaneous compartment by transport of an analyte from interstitial fluids in the subcutaneous compartment to the therapeutic fluid;

withdrawing at least part of the volume of the therapeutic fluid out of the subcutaneous compartment and into the patch unit via the cannula and a second conduit separate from the first conduit by operating the pumping mechanism to displace the at least part of the volume in a reverse direction;

measuring an analyte concentration in the withdrawn volume using a sensing element within the patch unit; and

providing regulation means for preventing the withdrawn volume from entering the reservoir while allowing the therapeutic fluid to exit from the reservoir.

2. A method as in claim 1, wherein the cannula comprises a permeable or semi-permeable surface through which molecules of the analyte diffuse during the substantially static state.

3. A method as in claim 1, wherein the cannula comprises a permeable surface through which molecules of the analyte microperfuse during the substantially static state.

4. A method as in claim 1, further comprising:

initiating a change to a delivery rate of the therapeutic fluid based on the measured analyte concentration.

5. A method as in claim 1, further comprising:

promoting a notification to a user interface, the notification requesting authorization of a proposed change to a delivery rate of the therapeutic fluid based on the measured analyte concentration.

6. A method as in claim 5, wherein the user interface is provided on a remote control unit that communicates with the patch unit, the remote control unit receiving fluid delivery programming commands.

7. A method as in claim 1, further comprising:

converting the measured analyte concentration in the at least part of the volume of the therapeutic fluid to a calculated analyte concentration in the interstitial fluid or in a blood of the user.

8. A method as in claim 1, wherein the measuring of the analyte concentration occurs via electrochemical or optical sensing.

9. A method as in claim 1, wherein the therapeutic biologically compatible fluid comprises is insulin or saline.

10. A method as in claim 1, wherein the analyte comprises is glucose.

11. A method as in claim 1, further comprising;

delivering the withdrawn volume back into the subcutaneous compartment by operating the pumping mechanism to displace the withdrawn volume in the forward direction.

12. A method as in claim 1, wherein the patch unit comprises:

a disposable part that comprises the reservoir; and

a reusable part that comprises a control processor, at least part of a detector system, and at least part of the pumping mechanism, the patch unit being operable upon connection of the disposable part and reusable part.

13. A method as in claim 12, wherein one or more components of the detector system reside in each of the reusable part and the disposable part.

14. A method as in claim 12, wherein the patch unit is removably mated with a cradle unit that comprises a skin contact surface configured for contact with skin of the user.

15. A method as in claim 14, wherein a disposable cannula cartridge unit that comprises the cannula is configured for mating with the cradle unit to position a distal end of the cannula in the subcutaneous compartment and enabling communication of the therapeutic fluid between the reservoir and the subcutaneous compartment via the cannula.

16. The method as in claim 1, further comprising storing the withdrawn at least part of the volume of the therapeutic fluid in a waste reservoir.

17. The method as in claim 1, wherein, the regulation means comprises a check valve.

18. The method as in claim 1, wherein the regulation means comprises a reverse flow restrictor.

19. A patch unit for delivering a therapeutic fluid to a user and measuring a level of analyte in a user, the patch unit comprising:

a cannula having an insertable end configured for insertion into a subcutaneous compartment of the user;

a reservoir in fluid communication with the cannula, the reservoir comprising a therapeutic fluid;

a pumping mechanism that;

operates to displace the therapeutic fluid in a forward direction to deliver a volume of the therapeutic fluid from the reservoir into the subcutaneous compartment via a first conduit and the cannula,

suspends delivery of the therapeutic fluid to the subcutaneous compartment by entering a substantial static state such that the therapeutic fluid achieves at least a partial analyte concentration equilibrium with interstitial fluids in the subcutaneous compartment by transport of an analyte from interstitial fluids in the subcutaneous compartment to the therapeutic fluid, and

operates to displace the therapeutic fluid in a reverse direction to withdraw at least part of the volume of the therapeutic fluid out of the subcutaneous compartment and into the patch unit via the cannula and a second conduit separate from the first conduit,

a sensing element that measures an analyte concentration in the at least part of the volume of the therapeutic fluid withdrawn from the subcutaneous compartment; and

regulation means for preventing the withdrawn volume from entering the reservoir while allowing the therapeutic fluid to exit from the reservoir.

20. The patch unit as in claim 19, further comprising a waste reservoir for storing the withdrawn at least part of the volume of the therapeutic fluid.

21. The patch unit as in claim 19, wherein the regulation means comprises a check valve.

22. The patch unit as in claim 19, wherein the regulation means comprises a reverse flow restrictor.