Wearable pump assembly

• US 9,526,830 B2
• Filed: 12/31/2008
• Issued: 12/27/2016
• Est. Priority Date: 12/31/2007
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Kamen, Dean, Gray, Larry Brian, Lanigan, Richard J., Kerwin, John Matthew, Fichera, Stephen Lewis
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US12/347,982
• Publication Number:
  US 20090281497A1
• Time in Patent Office: 2,918 Days
• Field of Search: 604/65, 604/67, 604/118, 604/131, 604/134, 604151-153, 604/246, 604/247, 604/257, 604/890.1
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2209/086 Docking stations
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A wearable infusion pump assembly includes a reusable housing assembly, and a disposable housing assembly including a reservoir for receiving an infusible fluid. A releasable engagement assembly is configured to allow the reusable housing assembly to releasably engage the disposable housing assembly. A detachable external infusion set is configured to deliver the infusible fluid to a user.

Claims

1. A wearable infusion pump assembly comprising:

a reusable housing assembly;

a disposable housing assembly comprising a base, a reservoir formed at least partly by the base to be integral to the disposable housing assembly, the reservoir for receiving an infusible fluid, and a fluid path extending through the disposable housing and connected to the reservoir;

a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly;

a detachable external infusion set including tubing connected to the fluid path of the disposable housing assembly and configured to receive infusible fluid from the reservoir through the fluid path and to deliver the infusible fluid to a user;

a bolus switch on the reusable housing assembly, the bolus switch configured to effectuate a bolus infusion event;

at least one processor; and

a computer readable medium coupled to the at least one processor, the computer readable medium including a plurality of instructions stored thereon which, when executed by the at least one processor, cause the at least one processor to perform operations comprising;

receiving an initiation signal from the bolus switch indicative of a bolus infusion event;

receiving a dose signal from the bolus switch indicative of at least a portion of a bolus quantity of the infusible fluid;

rendering an audible quantity signal in response to the dose signal; and

receiving an approval signal from the bolus switch indicative of a concurrence with the audible quantity signal.

2. The wearable infusion pump assembly of claim 1 wherein the computer readable medium further includes instructions for:

administering the bolus quantity of the infusible fluid.

3. The wearable infusion pump assembly of claim 1 wherein the detachable external infusion set is a tethered infusion set.

4. The wearable infusion pump assembly of claim 1 wherein the detachable external infusion set includes a first disconnect assembly configured to releasably couple the detachable external infusion set to the disposable housing assembly.

5. The wearable infusion pump assembly of claim 1 wherein the detachable external infusion set includes:

a cannula assembly;

a tubing assembly; and

a second disconnect assembly configured to releasably couple the tubing assembly to the cannula assembly.

6. The wearable infusion pump assembly of claim 1 wherein the reusable housing assembly includes:

a mechanical control assembly having a pump assembly and at least one valve assembly; and

an electrical control assembly configured to provide one or more control signals to the mechanical control assembly and effectuate the delivery of the infusible fluid to the user via the detachable external infusion set.

7. The wearable infusion pump assembly of claim 6 wherein the mechanical control assembly includes at least one shape-memory actuator.

8. A wearable infusion pump assembly comprising:

a reusable housing assembly;

a disposable housing assembly including a reservoir for receiving an infusible fluid;

a locking ring assembly rotationally coupled to a periphery of the reusable housing assembly and configured to rotate about a periphery of the disposable housing assembly to rotationally engage an engagement feature disposed on the periphery of the disposable housing assembly to releasably engage the reusable housing assembly to the disposable housing assembly;

an alignment assembly configured to provide an indication of alignment and complete rotational engagement between the reusable housing assembly and the disposable housing assembly;

a bolus switch on the reusable housing assembly, the bolus switch configured to effectuate a bolus infusion event;

at least one processor; and

a computer readable medium coupled to the at least one processor, the computer readable medium including a plurality of instructions stored thereon which, when executed by the at least one processor, cause the at least one processor to perform operations comprising;

receiving an initiation signal from the bolus switch indicative of a bolus infusion event;

receiving a dose signal from the bolus switch indicative of at least a portion of a bolus quantity of the infusible fluid;

rendering an audible quantity signal in response to the dose signal; and

receiving an approval signal from the bolus switch indicative of a concurrence with the audible quantity signal.

9. The wearable infusion pump assembly of claim 8 wherein the computer readable medium further includes instructions for:

administering the bolus quantity of the infusible fluid.

10. The wearable infusion pump assembly of claim 8 wherein the releasable engagement assembly includes:

a sealing assembly configured to provide a seal between the reusable housing assembly and the disposable housing assembly.

11. The wearable infusion pump assembly of claim 10 wherein the sealing assembly includes an o-ring assembly.

12. The wearable infusion pump assembly of claim 10 wherein the sealing assembly includes an over molded seal assembly.

13. The wearable infusion pump assembly of claim 10 wherein the sealing assembly is a watertight seal assembly.

14. A wearable infusion pump comprising:

a reusable housing;

a disposable housing including a reservoir for receiving an infusible fluid;

a locking ring assembly rotationally coupled to a periphery of the reusable housing assembly and configured to rotate about a periphery of the disposable housing assembly to rotationally engage an engagement feature disposed on the periphery of the disposable housing assembly to allow the reusable housing to releasably engage the disposable housing;

a bolus switch on the reusable housing, the bolus switch configured to effectuate a bolus infusion event;

at least one processor; and

a computer readable medium coupled to the at least one processor, the computer readable medium including a plurality of instructions stored thereon which, when executed by the at least one processor, cause the at least one processor to perform operations comprising;

receiving an initiation signal from the bolus switch indicative of a bolus infusion event;

receiving a dose signal from the bolus switch indicative of at least a portion of a bolus quantity of the infusible fluid;

rendering an audible quantity signal in response to the dose signal; and

receiving an approval signal from the bolus switch indicative of a concurrence with the audible quantity signal.

15. The wearable infusion pump of claim 14 wherein the computer readable medium further includes instructions for:

administering the bolus quantity of the infusible fluid.