US2019143034A1PendingUtilityA1

Pump, motor and assembly for beneficial agent delivery

65
Assignee: ABBVIE INCPriority: Dec 31, 2013Filed: Jan 9, 2019Published: May 16, 2019
Est. expiryDec 31, 2033(~7.5 yrs left)· nominal 20-yr term from priority
F04B 43/12A61M 5/142A61M 2205/6054A61M 5/14228A61M 2205/16A61M 2205/14A61M 5/14244A61M 5/16831F04B 43/1223A61M 2205/50A61M 2205/12F04B 43/082A61M 2005/16863A61M 2205/502
65
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Claims

Abstract

Device for delivering a beneficial agent to a user includes a cassette including a cassette housing with a fluid reservoir, the cassette housing having a cassette base region, and a delivery tube. The device also includes a pump having a pump housing containing a pump assembly and having a receiving region to receive the cassette base region. The pump assembly includes a fluid drive component, a display, a plurality of input buttons. The pump assembly also includes a first processor coupled to the fluid drive component and the display and configured to reduce power to the fluid drive component and the display when the pump is in an inactive state, and a second processor coupled to the first processor and the plurality of input buttons, the second processor configured to provide an activation signal to the first processor when one or more of the plurality of input buttons is deployed.

Claims

exact text as granted — not AI-modified
1 - 10 . (canceled) 
     
     
         11 . A device for delivering a beneficial agent to a user, comprising:
 a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region;   a delivery tube fluidly coupled with the fluid reservoir;   a pump including a pump housing containing a pump assembly and having a receiving region to receive the cassette base region, the pump assembly including:
 a primary power source, 
 a secondary power source coupled to the primary power source, 
 a fluid drive component disposed proximate the receiving region and coupled to the primary power source and isolated from the secondary power source, 
 a first processor coupled to the primary power source and the secondary power source, 
 a second processor coupled to the first processor, the primary power source and the secondary power source, 
 one or more memories coupled to the first processor, and 
 at least one of the first processor and second processor configured, when the primary power source is removed or disabled, to utilize the secondary power source and the first processor to complete writing operations to the one or more memories prior to depletion of the secondary power source. 
   
     
     
         12 . The device of  claim 11 , wherein the secondary power source comprises a 1F capacitor. 
     
     
         13 . The device of  claim 11 , wherein the secondary power source is coupled to the primary power source via a secondary power source charger configured to charge the secondary power source when the primary power source is active. 
     
     
         14 . The device of  claim 11 , wherein the one or more memories comprises a nonvolatile memory storage. 
     
     
         15 . The device of  claim 11 , wherein the pump assembly further comprises an RFID transceiver coupled to the secondary power source. 
     
     
         16 . The device of  claim 11 , wherein the pump assembly further comprises a speaker coupled to the secondary power source, the first processor and the second processor each coupled to the speaker and configured to send an audio signal to the speaker when a fault is detected. 
     
     
         17 . The device of  claim 11 , wherein the pump assembly further comprises a display to provide visual feedback to the user, the display coupled to the primary power source and isolated from the secondary power source. 
     
     
         18 . The device of  claim 11 , wherein the pump assembly further comprises an occlusion sensor coupled to the primary power source and isolated from the secondary power source. 
     
     
         19 . The device of  claim 11 , further comprising a beneficial agent contained in the fluid reservoir. 
     
     
         20 . The device of  claim 19 , wherein the beneficial agent comprises one or more of levodopa and carbidopa. 
     
     
         21 . A device for delivering a beneficial agent to a user, comprising:
 a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region;   a delivery tube fluidly coupled with the fluid reservoir;   a pump including a pump housing containing a pump assembly having a fluid drive component, the pump housing having a receiving region to receive the cassette base region, the fluid drive component disposed proximate the receiving region;   a contact force sensor in communication with the delivery tube and arranged to measure a force or pressure in the delivery tube; and   one or more processors in communication with the contact force sensor to receive data representing the measured force or pressure from the contact force sensor, the one or more processors configured to:
 determine a maximum force value detected by the contact force sensor during an initial pumping cycle, the maximum force value corresponding to a baseline maximum force value, 
 obtain subsequent force values from the contact force sensor during each subsequent pumping cycle, and 
 determine an occlusion is present if one or more of the subsequent force values exceed the baseline maximum force value by a threshold amount. 
   
     
     
         22 . The device of  claim 21 , wherein the one or more processors is further configured to:
 determine a subsequent maximum force value during the subsequent pumping cycle, and   adjust the baseline maximum force value to the subsequent maximum force value if the subsequent maximum force value is less than the baseline maximum force value.   
     
     
         23 . The device of  claim 21 , wherein the threshold amount is about 10% of the baseline maximum force value. 
     
     
         24 . The device of  claim 21 , wherein the one or more processors is further configured to:
 determine a local maximum force value during an initial pump revolution of each pump cycle, the local maximum force corresponding to a baseline local maximum force value,   obtain a subsequent local force maximum during each subsequent pump revolution of each pump cycle, and   determine an occlusion is present if one or more of the subsequent local force maxima exceeds the baseline local maximum force value by a local threshold amount.   
     
     
         25 . The device of  claim 24 , wherein the local threshold amount is about 13% of the baseline local maximum force value. 
     
     
         26 . The device of  claim 24 , wherein the one or more processors is further configured to determine the local maximum force value of each pump cycle when a flow rate of the fluid drive component is above a threshold flow rate. 
     
     
         27 . The device of  claim 26 , wherein the threshold flow rate is 10 mL/hr. 
     
     
         28 . The device of  claim 24 , wherein the one or more processors is further configured to:
 determine a local minimum force value detected by the contact force sensor during each revolution of each pumping cycle, and   determine an error is present if the local minimum force value does not exceed the local maximum force value of a corresponding pump cycle by a local minimum threshold amount.   
     
     
         29 . The device of  claim 28 , wherein the error comprises a mechanical failure of the fluid drive component. 
     
     
         30 . The device of  claim 28 , wherein the error comprises an occlusion signal circuitry failure. 
     
     
         31 . The device of  claim 21 , wherein a duration of each pumping cycle is determined at least in part by a flow rate of the fluid drive component. 
     
     
         32 . The device of  claim 21 , further comprising:
 a motor operatively coupled to the fluid drive component; and   a rotational position sensor operatively coupled to the motor to determine a rotational position of the motor;   wherein the one or more processors is further operatively coupled to the rotational position sensor and further configured to determine each pump revolution from the rotational position sensor   
     
     
         33 . The device of  claim 21 , wherein the one or more processors is further configured to stop the fluid drive component when the occlusion is determined to be present. 
     
     
         34 . The device of  claim 21 , further comprising a display operatively coupled to the one or more processors, wherein the one or more processors is further configured to display an error signal on the display when the occlusion is determined to be present. 
     
     
         35 . The device of  claim 21 , wherein the contact force sensor consists of a single contact force sensor. 
     
     
         36 . The device of  claim 21 , wherein the one or more processors is further configured to apply a four-sample moving average filter to the data representing the measured force or pressure from the contact force sensor. 
     
     
         37 . The device of  claim 21 , further comprising a beneficial agent contained in the fluid reservoir. 
     
     
         38 . The device of  claim 37 , wherein the beneficial agent comprises one or more of levodopa and carbidopa. 
     
     
         39 . A device for delivering a beneficial agent to a user, comprising:
 a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region;   a delivery tube fluidly coupled with the fluid reservoir;   a pump including a pump housing containing a pump assembly having a fluid drive component, the pump housing having a receiving region to receive the cassette base region, the fluid drive component and a proximity sensor disposed proximate the receiving region;   a lock member coupled to the pump housing and movable between an open position and a closed position, the cassette capable of being inserted into and removed from the receiving region when the lock member is in the open position, and the cassette being secured to the pump with the cassette base region within the receiving region and a length of the delivery tube in operative engagement with the fluid drive component when the lock member is in the closed position, the lock member comprising a proximity tag configured to be disposed proximate the proximity sensor when the lock member is in the closed position;   a contact force sensor in communication with the delivery tube and arranged to measure a force or pressure in the delivery tube; and   one or more processors in communication with the proximity sensor and the contact force sensor to receive a proximity signal and contact force data, respectively, therefrom, the one or more processors configured to:
 determine whether the lock member is in the closed position using the proximity signal, 
 determine whether the delivery tube is in operative engagement with the fluid drive component using the contact force data, and 
 enable operation of the fluid drive component if the lock member is determined to be in the closed position and the delivery tube is determined to be in operative engagement with the fluid drive component. 
   
     
     
         40 . The device of  claim 39 , wherein the proximity sensor comprises a reed switch. 
     
     
         41 . The device of  claim 39 , wherein the proximity tag comprises a magnet. 
     
     
         42 . The device of  claim 39 , wherein the one or more processors is further configured to:
 compare the contact force data to a threshold value, and   determine the delivery tube is in operative engagement with the fluid drive component if the contact force data exceeds the threshold value.   
     
     
         43 . The device of  claim 39 , wherein the one or more processors is further configured to:
 determine a local minimum force value detected by the contact force sensor during each revolution of each pumping cycle, and   determine the delivery tube is in operative engagement with the fluid drive component if the local minimum force value exceeds the local maximum force value of a corresponding pump cycle by a local minimum threshold amount.   
     
     
         44 . The device of  claim 39 , wherein a cassette base region comprises a radio frequency identification (RFID) tag, and the pump comprises an RFID reader configured to read the RFID tag when the cassette is secured to the pump. 
     
     
         45 . The device of  claim 44 , wherein the one or more processors is further configured to:
 receive identification information for the cassette encoded on the RFID tag from the RFID reader,   determine whether the identification information is valid, and   enable operation of the fluid drive component if the identification information is valid.   
     
     
         46 . The device of  claim 45 , wherein the RFID tag further comprises an expiration date of the beneficial agent, and the one or more processors is further configured to:
 receive the expiration date of the beneficial agent from the RFID reader,   determine whether the expiration date is exceeded, and   enable operation of the fluid drive component if the expiration date is not exceeded.   
     
     
         47 . The device of  claim 45 , wherein the RFID tag comprises high or ultra-high radio frequency ID. 
     
     
         48 . The device of  claim 39 , further comprising a beneficial agent contained in the fluid reservoir. 
     
     
         49 . The device of  claim 48 , wherein the beneficial agent comprises one or more of levodopa and carbidopa. 
     
     
         50 . A device for delivering a beneficial agent to a user, comprising:
 a cassette including a cassette housing with a fluid reservoir defined therein, the cassette housing having a cassette base region including a RFID tag;   a delivery tube fluidly coupled with the fluid reservoir;   a pump including a pump housing containing a pump assembly including a fluid drive component, a proximity sensor and a RFID reader, the pump housing having a receiving region to receive the cassette base region, wherein the fluid drive component, the proximity sensor and the RFID reader are disposed proximate the receiving region, and the RFID reader is configured to read the RFID tag when the cassette is secured to the pump;   a lock member coupled to the pump housing and movable between an open position and a closed position, the cassette capable of being inserted into and removed from the receiving region when the lock member is in the open position, and the cassette being secured to the pump with the cassette base region within the receiving region and a length of the delivery tube in operative engagement with the fluid drive component when the lock member is in the closed position, the lock member comprising a proximity tag configured to be disposed proximate the proximity sensor when the lock member is in the closed position;   a contact force sensor in communication with the delivery tube and arranged to measure a force or pressure in the delivery tube; and   one or more processors in communication with the proximity sensor, the contact force sensor and the RFID reader to receive a proximity signal, contact force data and identification information for the cassette encoded on the RFID tag, respectively, therefrom, the one or more processors configured to:
 determine whether the lock member is in the closed position using the proximity signal, 
 determine whether the delivery tube is in operative engagement with the fluid drive component using the contact force data, 
 determine whether the identification information is valid, and 
 enable operation of the fluid drive component if the lock member is 
 determined to be in the closed position, the delivery tube is determined to be in operative engagement with the fluid drive component and the identification information is determined to be valid. 
   
     
     
         51 . The device of  claim 50 , wherein the RFID tag further comprises an expiration date of the beneficial agent, and the one or more processors is further configured to:
 receive the expiration date of the beneficial agent from the RFID reader,   determine whether the expiration date is exceeded, and   enable operation of the fluid drive component if the expiration date is not exceeded.   
     
     
         52 . The device of  claim 50 , wherein the RFID tag comprises high or ultra-high radio frequency ID. 
     
     
         53 . The device of  claim 50 , further comprising a beneficial agent contained in the fluid reservoir. 
     
     
         54 . The device of  claim 53 , wherein the beneficial agent comprises one or more of levodopa and carbidopa.

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