Vented dispensing device and method

• US 8,491,529 B2
• Filed: 07/20/2008
• Issued: 07/23/2013
• Est. Priority Date: 07/20/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Neta, Avraham
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/452,764
• Publication Number:
  US 20100198187A1
• Time in Patent Office: 1,829 Days
• Field of Search: 604/890.1, 604/131, 604/151
• US Class Current: 604/131
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/82 Internal energy supply devices
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir
• CPC Class Codes: A61M 5/16822 by controlling air intake into infusion reservoir needle sets with air inlet A61M5/162
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Disclosed is a fluid dispensing device that includes at least one reservoir to hold the therapeutic fluid, at least one other unit requiring communication with ambient air, at least partly, to operate, and at least one housing defining an interior to retain the at least one reservoir and the at least one other unit. The at least one housing has at least one vent port formed on one or more of its walls. The at least one vent port is adapted to direct or communicate air to maintain pressure equilibrium between the air pressure in the interior of the at least one housing and the ambient air pressure outside the at least one housing, and provide communication with the ambient air to the at least one other unit requiring air to enable operation of the at least one other unit.

Claims

1. A fluid dispensing device for delivery of a therapeutic fluid to a user'"'"'s body, the fluid dispensing device comprising:

a disposable part housing comprising at least one reservoir to hold the therapeutic fluid, and at least one other unit requiring communication with ambient air, at least partly, to operate;

a reusable part housing including at least a portion of a driving mechanism, an audible notification module disposed in the reusable part housing, and electronic components having a processor;

at least one vent port formed on one or more walls of at least one of the disposable part housing and the reusable part housing; and

a semi-permeable membrane covering the at least one vent port, the membrane being impervious to at least one liquid but pervious to at least one gas;

wherein the at least one vent port is configured for communicating air into at least one of the disposable part housing and the reusable part housing, and directing sound and/or vibration generated by the audible notification module as a notification regarding a condition of the fluid dispensing device; and

wherein the at least one other unit includes a sensor to determine a body analyte level and wherein the at least one vent port is configured for providing air to the sensor to enable its operation.

2. The device of claim 1, wherein the at least one other unit includes at least one energy source comprising at least one electrochemical cell to produce electrical energy upon exposure to air.

3. The fluid dispensing device of claim 2, wherein the at least one electrochemical cell comprises a Zinc-air battery.

4. The fluid dispensing device of claim 2, wherein the reusable part housing includes the at least one vent port.

5. The fluid dispensing device of claim 1, wherein as a result of the pressure equilibrium, controlled delivery of the therapeutic fluid from the at least one reservoir to the body of the user is enabled.

6. The fluid dispensing device of claim 1, wherein the semi-permeable membrane comprises a water repelling fabric.

7. The fluid dispensing device of claim 1, wherein the semi-permeable membrane comprises a polymer.

8. The fluid dispensing device of claim 1, wherein the semi-permeable membrane comprises GORE-TEX®

.

9. The fluid dispensing device of claim 1, wherein the semi-permeable membrane comprises CELGARD®

.

10. The fluid dispensing device of claim 1, wherein the semi-permeable membrane is configured to provide a rate of gas transfer greater than or equal to about 0.1 micro-liter per hour at a temperature of about 300°

K and pressure conditions of about 1 atm.

11. The fluid dispensing device of claim 1, wherein the semi-permeable membrane is configured to provide a rate of gas transfer greater than or equal to about 2.5 micro liter per second at a temperature of about 300°

K and pressure conditions of about 1 atm.

12. The fluid dispensing device of claim 1, wherein the disposable part housing and the reusable part housing are substantially sealed when operatively coupled to each other, and wherein at least one of the disposable part housing and the reusable part housing allow ingress of liquids when not operatively coupled to the other part.

13. The fluid dispensing device of claim 1, further comprising at least one seal to substantially close the at least one vent port to prevent entry of air into the disposable part housing and/or the reusable part housing through the at least one vent port when the device is not in operation.

14. The fluid dispensing device of claim 1, wherein the at least one vent port is configured for communicating air into at least one of the disposable part housing and the reusable part housing to maintain pressure equilibrium between the air pressure therein and the ambient air pressure thereout, and provide communication with the ambient air to the at least one other unit requiring air to enable operation of the at least one other unit.

15. A fluid dispensing device for delivery of a therapeutic fluid to a user'"'"'s body, the fluid dispensing device comprising:

a disposable part housing comprising at least one reservoir to hold the therapeutic fluid, at least one sensor to determine a body analyte level, and at least one energy source comprising at least one Zinc-air battery which provides energy upon exposure to air;

a reusable part housing including at least a portion of a driving mechanism and electronic components having a processor, wherein the disposable part housing and the reusable part housing are substantially sealed when operatively coupled to each other, and wherein at least one of the disposable part housing and the reusable part housing allows ingress of liquids when not operatively coupled to the other part;

at least one vent port formed on one or more walls of at least one of the disposable part housing and the reusable part housing;

a semi-permeable membrane comprising a water-repelling fabric which substantially covers and/or is provided at the at least one vent port, the membrane being impervious to at least one liquid but pervious to at least one gas;

wherein the at least one vent port is configured for communicating air into at least one of the disposable part housing and the reusable part housing to at least one of;

maintain pressure equilibrium between the air pressure therein and the ambient air pressure thereout, and

provide communication with the ambient air to the at least one Zinc-air battery and, to the at least one sensor to enable operation of the at least one Zinc-air battery and the at least one sensor,

and wherein as a result of the pressure equilibrium, controlled delivery of the therapeutic fluid from the at least one reservoir to the body of the user is enabled;

and

an audible notification module disposed in the reusable part housing, wherein the at least one vent port is further configured to direct sound and/or vibration generated by the audible notification module as a notification regarding a condition of the fluid dispensing device.

16. A method for delivery of a therapeutic fluid to a user'"'"'s body using a fluid dispensing device, comprising:

providing a fluid dispensing device comprising;

a disposable part housing comprising at least one reservoir to hold the therapeutic fluid, at least one sensor to determine a body analyte level, and at least one energy source comprising at least one Zinc-air battery which provides energy upon exposure to air;

a reusable part housing including at least a portion of a driving mechanism, an audio notification module, and electronic components having a processor;

at least one vent port formed, on one or more walls of at least one of the disposable part housing and the reusable part housing;

a semi-permeable membrane which substantially covers and/or is provided at the at least one vent port, the membrane being impervious to at least one liquid but pervious to at least one gas,

wherein the at least one vent port is configured for communicating air into at least one of the disposable part housing and the reusable part housing to at least one of;

maintain pressure equilibrium between the air pressure therein and the ambient air pressure there out, and

provide communication with the ambient air to the at least one Zinc air battery requiring air and to the at least one sensor to enable operation of the at least one Zinc air battery and the at least one sensor, and

wherein the at least one vent port is further configured to direct sound and/or vibration generated by the audible notification module as a notification regarding a condition of the fluid dispensing device;

operatively coupling the disposable part housing and the reusable part housing together, wherein as a result of such coupling;

the disposable part housing and the reusable part housing are substantially sealed,

ambient air flow is established to the Zinc-air battery enabling operation of the fluid dispensing device, and

therapeutic fluid is provided to the user.