Device for subcutaneous delivery of fluid medicament

Abstract

An improved device delivers a fluid medicament to the subcutaneous tissue of a user. The device is better suited for patients with Parkinson's Disease and other central nervous system disorders, than conventional infusion devices. The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament reservoir. Medicament can be evacuated from the medicament reservoir by a plunger assembly that includes a plunger attached to a lead screw that is rotated by a nut, all within the disposable part. The device can be fluidically coupled with the tissue via a flexible cannula. Various embodiments relate to an improved cannula insertion mechanism that delivers the cannula under a force applied by a spring. Various embodiments relate to improved filling of the device, for example, using a vial adapter and an automated filling station.

1 . A device for delivering a fluid medicament to a user, the device comprising:
 a reusable part comprising:
 a drive component, and 
 a control unit for controlling the drive component; and 
   a disposable part attachable to the reusable part, the disposable part comprising:
 a reservoir for containing the fluid medicament, 
 a plunger for driving the fluid medicament out of the reservoir, 
 a lead screw attached to the plunger, and 
 a nut operable to displace the lead screw, wherein when the reusable part and the disposable part are attached, the nut is operably coupled with the drive component. 
   
     
     
         2 . The device of  claim 1 , wherein the reservoir contains the fluid medicament comprising a liquid formulation of at least one of levodopa and carbidopa. 
     
     
         3 . The device of  claim 1 , wherein at least one of the reusable part and the disposable part further comprises a battery for powering the drive component. 
     
     
         4 . The device of  claim 1 , wherein the drive component comprises a motor assembly. 
     
     
         5 . The device of  claim 4 , wherein the motor assembly comprises a motor and a planetary gear. 
     
     
         6 . The device of  claim 1 , wherein the reusable part further comprises a drive train coupled to the drive component, wherein the drive train comprises at least one gear. 
     
     
         7 . The device of  claim 6 , wherein the at least one gear comprises a drive gear, an idler gear, and a load gear in series. 
     
     
         8 .- 37 . (canceled) 
     
     
         38 . A method for delivering a fluid medicament to a user, the method comprising the steps of:
 providing a device comprising:
 a reusable part comprising:
 a drive component, and 
 a control unit for controlling the drive component; and 
 
 a disposable part attachable to the reusable part, the disposable part comprising:
 a reservoir for containing the fluid medicament, 
 a plunger for driving the fluid medicament out of the reservoir, 
 a lead screw attached to the plunger, and 
 a nut operable to displace the lead screw, wherein when the reusable part and the disposable part are attached, the nut is operably coupled with the drive component; 
 
   fluidically coupling the device to the subcutaneous tissue of the user; and   controlling the device such that the fluid medicament is delivered from the device to the subcutaneous tissue of the user.   
     
     
         39 .- 74 . (canceled) 
     
     
         75 . A device for delivering a fluid medicament to a user, the device comprising:
 a pump module comprising at least one reservoir for containing the fluid medicament; and   a cannula insertion mechanism attachable to the pump module, the cannula insertion mechanism comprising:
 an insertion needle, and 
 a cannula assembly comprising a flexible cannula connected to a rigid fluidic link and detachably coupled with the insertion needle such that, when the flexible cannula is located in subcutaneous tissue of the user, the cannula assembly fluidically couples the reservoir to the subcutaneous tissue via the rigid fluidic link. 
   
     
     
         76 .- 108 . (canceled) 
     
     
         109 . A method for delivering a fluid medicament to a user, the method comprising the steps of:
 providing a pump module comprising at least one reservoir for containing the fluid medicament;   attaching a cannula insertion mechanism to the pump module, the cannula insertion mechanism comprising:
 an insertion needle, and 
 a cannula assembly comprising a flexible cannula connected to a rigid fluidic link and detachably coupled with the insertion needle; and 
   fluidically coupling the pump module to subcutaneous tissue of the user such that, the cannula assembly fluidically couples the reservoir to the subcutaneous tissue via the rigid fluidic link.   
     
     
         110 .- 142 . (canceled) 
     
     
         143 . A control unit for a device delivering a fluid medicament to a user, the device including a fluid medicament drive component, at least one patient sensor for detecting a medical condition status of the user, and a clock, the control unit comprising:
 a drive component module operable to control the drive component and deliver the fluid medicament based on signals received from both the at least one patient sensor and the clock.   
     
     
         144 .- 153 . (canceled) 
     
     
         154 . A method of controlling a device delivering a fluid medicament to a user, the device including a fluid medicament drive component, at least one patient sensor for detecting a medical condition status of the user, and a clock, the method comprising the steps of:
 receiving a signal from the at least one patient sensor;   receiving a signal from the clock; and   controlling the drive component to deliver the fluid medicament based the signals received from both the at least one patient sensor and the clock.   
     
     
         155 .- 164 . (canceled) 
     
     
         165 . A charging/filling station for a device operable to deliver a fluid medicament to a user, the charging/filling station comprising:
 a cradle for receiving the device;   a charging unit operable to charge a rechargeable battery of the device;   a display; and   a communication module operable to instruct at least one of a control unit and a drive component of the device to initiate a filling operation of the device.   
     
     
         166 .- 179 . (canceled) 
     
     
         180 . A method of charging/filling a device operable to deliver a fluid medicament to a user, the method comprising the steps of:
 receiving the device within a cradle;   charging a rechargeable battery of the device with a charging unit; and   instructing at least one of a control unit and a drive component of the device to initiate a filling operation of the device.   
     
     
         181 .- 194 . (canceled) 
     
     
         195 . A medicament vial adapter for use with a device for delivering a fluid medicament to a user, the device including a reservoir for containing the fluid medicament, the medicament vial adapter comprising:
 a first port operable to connect to the reservoir,   a second port operable to connect to a medicament vial containing the fluid medicament, and   a needle disposed in the first and second ports, wherein when the vial adapter is connected to the reservoir and the medicament vial, the needle fluidically couples the medicament vial to the reservoir.   
     
     
         196 .- 199 . (canceled) 
     
     
         200 . A method for filling a device for delivering a fluid medicament to a user, the device including a reservoir for containing the fluid medicament, the method comprising the steps of:
 connecting a first port of a medicament vial adapter to the reservoir;   connecting a second port of the medicament vial adapter to a medicament vial containing the fluid medicament; and   disposing a needle in the first and second port to fluidically couple the medicament vial to the reservoir.   
     
     
         201 .- 204 . (canceled) 
     
     
         205 . A filling system comprising:
 a device for delivering a fluid medicament to a user, the device comprising a reservoir for receiving and containing the fluid medicament; and   a vial adapter comprising:
 a first port operable to connect to the reservoir, 
 a second port operable to connect to a medicament vial containing the fluid medicament, and 
 a needle disposed in the first and second ports, wherein when the vial adapter is connected to the reservoir and the medicament vial, the needle fluidically couples the medicament vial with the reservoir. 
   
     
     
         206 . A holder for securing a pump device to a user, the holder comprising:
 a receiving portion operable to receive the pump device and detachably retain the pump device;   an attachment component for attaching the holder to at least one of the user and an article of clothing worn by the user; and   a position altering component interdisposed between the receiving portion and the attachment component to alter at least one of a position and an orientation of the pump relative to the holder.   
     
     
         207 .- 210 . (canceled) 
     
     
         211 . A method for securing a pump device to a user, the method comprising the steps of:
 receiving and detachably retaining the pump device on a holder;   attaching the holder to at least one of the user and an article of clothing worn by the user; and   altering a relative position of the pump device using a position altering component on the holder.   
     
     
         212 .- 215 . (canceled) 
     
     
         216 . A method for setting operating parameter values of a pump device for delivering fluid medicament to a user, the method comprising the steps of:
 receiving user-defined pump operating values;   determining whether the received user-defined pump operating values are within allowed operating parameter limits;   if the received user-defined pump operating values are within allowed operating parameter limits, controlling operation of the pump device according to the received user-defined pump operating parameter values; and   if the received user-defined pump operating values are not within allowed operating parameter limits, controlling operation of the pump device according to default pump operating values.