Infusion pump assembly

Abstract

A wearable infusion pump assembly including a reservoir for receiving an infusible fluid, and a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set. The fluid delivery system includes a volume sensor assembly configured to receive a quantity of the infusible fluid from the reservoir. The volume sensor assembly includes an acoustically contiguous region having a volume that varies based upon the quantity of infusible fluid received from the reservoir, and an acoustic energy emitter configured to provide acoustic energy at a plurality of frequencies to excite a gas included within the acoustically contiguous region.

1 - 20 . (canceled) 
     
     
         21 . A method for pairing a remote control assembly and a wearable infusion pump assembly, the wearable infusion pump assembly having a reusable housing assembly, a disposable housing assembly including a reservoir with an infusible fluid, a switch assembly configured to effectuate a functionality of an infusion pump assembly, a processor, and a computer readable medium coupled to the processor, the computer readable medium including a plurality of instructions stored thereon which, when executed by the processor, cause the processor to perform operations, the method comprising:
 releasably engaging the reusable housing assembly to the disposable housing assembly;   receiving a pairing initiation signal from the switch assembly indicative of a pairing event;   monitoring for receipt of a pairing request from a remote control assembly;   if the pairing request is received, providing a pairing request acknowledgment message to the remote control assembly, wherein the pairing request acknowledgement message uniquely identifies the wearable infusion pump assembly;   monitoring for receipt of a pairing confirm request from the remote control assembly; and   if the pairing confirm request is received, providing a pairing confirm acknowledgment message to the remote control assembly.   
     
     
         22 . The method of  claim 21  wherein wherein the computer readable medium further includes a second plurality of instructions stored thereon which, when executed by the processor, the method further comprising:
 receiving an initiation signal from the switch assembly indicative of a bolus infusion event; 
 receiving a dose signal from the switch assembly 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 switch assembly indicative of a concurrence with the audible quantity signal. 
 
     
     
         23 . The method of  claim 22  further comprising:
 administering the bolus quantity of the infusible fluid. 
 
     
     
         24 . The method of  claim 21  wherein the functionality includes a separation detection functionality, the method further comprising:
 transmitting a ping signal to the remote control assembly; 
 monitoring for receipt of a reply signal from the remote control assembly in response to the ping signal; and 
 if the reply signal is not received within a defined period of time, rendering an audible separation alarm. 
 
     
     
         25 . The method of  claim 24  further comprising the steps of:
 receiving an alarm override signal from the switch assembly indicative of a desire to silence the separation alarm; and 
 silencing the separation alarm. 
 
     
     
         26 . The method of  claim 21 , wherein providing a pairing confirm acknowledgment message to the remote control assembly further includes providing a serial number of the wearable infusion pump assembly. 
     
     
         27 . The method of  claim 21 , further comprising:
 administering a bolus quantity of the infusible fluid via the wearable infusion pump assembly.   
     
     
         28 . The method of  claim 21  wherein the step of releasably engaging includes rotating the reusable housing assembly and disposable housing assembly relative to each other. 
     
     
         29 . A method for pairing a remote control assembly to an infusion pump assembly, the infusion pump assembly having a disposable housing assembly including a reservoir with an infusible fluid, a reusable housing assembly including a mechanical control assembly wherein the mechanical control assembly including a pump assembly with at least one shape-memory actuator configured to actuate the pump assembly and at least one valve assembly, and a switch assembly configured to effectuate a pairing functionality of the infusion pump assembly, the method comprising:
 releasably engaging the reusable housing assembly to e the disposable housing assembly;   receiving a pairing initiation signal from the switch assembly included within the wearable infusion pump assembly, the pairing initiation signal indicative of a pairing event;   monitoring for receipt of a pairing request from a remote control assembly;   if the pairing request is received, providing a pairing request acknowledgment message to the remote control assembly, wherein the pairing request acknowledgement message uniquely identifies the wearable infusion pump assembly;   monitoring for receipt of a pairing confirm request from the remote control assembly; and   if the pairing confirm request is received, providing a pairing confirm acknowledgment message to the remote control assembly.   
     
     
         30 . The method of  claim 29 , wherein providing a pairing confirm acknowledgment message to the remote control assembly further includes proving a serial number of the wearable infusion pump assembly. 
     
     
         31 . The method of  claim 29 , further comprising:
 administering a bolus quantity of the infusible fluid via the wearable infusion pump assembly.   
     
     
         32 . The method of  claim 29  wherein the functionality includes a separation detection functionality, the method further comprising:
 transmitting a ping signal to the remote control assembly; 
 monitoring for receipt of a reply signal from the remote control assembly in response to the ping signal; and 
 if the reply signal is not received within a defined period of time, rendering an audible separation alarm. 
 
     
     
         33 . The method of  claim 32  further comprising the steps of:
 receiving an alarm override signal from the switch assembly indicative of a desire to silence the separation alarm; and 
 silencing the separation alarm. 
 
     
     
         34 . A method of operating a wearable infusion pump assembly having a disposable housing assembly comprising a base with a reservoir formed at least partly by the base and holding an infusible fluid, a reusable housing assembly, a releasable engagement assembly configured to allow the reusable housing assembly to releasably engage the disposable housing assembly, a bolus switch on the reusable housing assembly, the bolus switch configured to effectuate a bolus infusion event, a processor with
 a computer readable medium including a plurality of instructions stored thereon which when executed by the processor cause the at least one processor to perform operations, the method comprising:   releasably engaging the disposable housing assembly to the   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.   
     
     
         35 . The method of  claim 34  further comprising:
 administering the bolus quantity of the infusible fluid. 
 
     
     
         36 . The method of  claim 34  wherein the reusable housing assembly further includes a mechanical control assembly having a pump assembly and a valve assembly, the method further comprising:
 transmitting a control signal to the mechanical control assembly to actuate the pump assembly and valve assembly to effectuate the delivery of the bolus quantity of the infusible fluid. 
 
     
     
         37 . A method of operating a wearable infusion pump assembly having a reusable housing assembly with a bolus switch configured to effectuate a bolus infusion event and a processor with a computer readable medium including a plurality of instructions stored thereon which when executed by the processor, cause the at least one processor to perform operations, and a disposable housing assembly including a reservoir having an infusible fluid rotationally and releaseably coupleable to the reusable housing assembly with an indication of alignment and complete rotational engagement between and the disposable housing assembly and the reusable housing assembly, the method comprising:
 rotationally coupling the reusable housing assembly to the disposable housing assembly whereby the indication of alignment indicates complete rotational engagement;   actuating the bolus switch;   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.   
     
     
         38 . The method of  claim 37  further comprising:
 administering the bolus quantity of the infusible fluid. 
 
     
     
         39 . A method of measuring the fluid dose of wearable infusion pump assembly having a disposable housing assembly including the reservoir with an infusible fluid, a reusable housing assembly releasably coupleable to the disposable assembly, a fluid delivery system, and a volume sensor assembly configured to receive and measure a quantity of the infusible fluid from the reservoir, the volume sensor assembly having a first acoustic energy receptor, a second acoustic energy receptor, and an acoustic energy emitter, the method comprising:
 coupling the reusable housing assembly to the disposable housing assembly;   emitting a plurality of frequencies with the acoustic energy emitter;   determining an acoustic response to each frequency   determining a phase relationship between the acoustic response and the reference for each of the plurality of frequencies, and   calculating a change of volume characteristic based, at least in part, upon the phase relationship between the acoustic response and the acoustic reference for each of the plurality of frequencies;   extracting infusible fluid from the reservoir with the fluid delivery assembly and providing the the infusible fluid to the volume sensor assembly; and   determining the quantity of infusible fluid delivered to the volume sensor assembly.   
     
     
         40 . The wearable infusion pump assembly of  claim 39  further comprising:
 providing an the acoustically contiguous region in the volume sensor assembly; 
 providing a variable volume chamber having a volume that varies based upon the quantity of infusible fluid received from the reservoir, 
 providing a fixed volume chamber having a volume that is constant regardless of the quantity of infusible fluid received from the reservoir; 
 providing an acoustic port for acoustically coupling the variable volume chamber to the fixed volume chamber; 
 positioning the first acoustic energy receptor proximate the variable volume chamber; and 
 positioning the second acoustic energy receptor proximate the at least one fixed volume chamber.