Fluid delivery apparatus having a controller assembly and method of use

Abstract

A method for administering a medicament suitable for treating a migraine or cluster headache to a patient in need thereof includes placing a mounting surface of a fluid delivery apparatus with the medicament in contact with at least a portion of the skin of said patient. A flow rate of the medicament from the fluid delivery apparatus is adjusted such that the medicament is delivered to the patient for at least a predetermined time period. The fluid delivery apparatus includes a controller assembly having a body component defining an axis and a plunger component slidably coupled to the body component. The plunger is positionable between a first position in which the plunger is nearest to the body component and a second position in which the plunger component is furthest from the body component. A bias assembly is positioned between the body component and the plunger component. The bias assembly is configured to apply a two stage force profile to the plunger component. Also disclosed is a method for administering sumatriptan to a patient in need thereof such that the Cmax, Tmax and AUC are within predetermined, therapeutically effective values.

1 .- 27 . (canceled) 
     
     
         28 . A method for administering a medicament to a patient, the method comprising:
 placing a fluid delivery apparatus including a controller assembly and microneedles in contact with at least a portion of the skin of the patient, wherein the fluid delivery apparatus includes a cartridge assembly containing the medicament, wherein the controller assembly comprises:
 a body component defining an axis; 
 a plunger component slidably coupled to the body component, the plunger component positionable between a first position in which the plunger component is nearest to the body component, and a second position in which the plunger component is furthest from the body component; 
 at least one latch member configured to selectively engage and disengage the plunger component to selectively restrict and allow, respectively, relative movement between the body component and the plunger component; and 
 a bias assembly positioned between the body component and the plunger component, the bias assembly is configured to apply a two stage force profile to the plunger component in response to the at least one latch member selectively disengaging the plunger component; 
   activating the fluid delivery apparatus such that the microneedles penetrate the epidermis of the patient and the medicament flows at a flow rate from the cartridge assembly comprising the medicament into the patient as a result of a first force profile; and   changing a force profile of the fluid delivery apparatus from the first force profile to a second force profile such that the medicament is delivered to the patient as a result of the second profile.   
     
     
         29 . The method of  claim 28 , wherein the at least one latch member is configured to retain the plunger component in the first position when engaged with the plunger component. 
     
     
         30 . The method of  claim 28 , wherein the at least one latch member is configured to pivot between a first latch position in which the at least one latch member engages the plunger component, and a second latch position in which the at least one latch member is disengaged from the plunger component. 
     
     
         31 . The method of  claim 28 , wherein the controller assembly further comprises at least one retention plate coupled to the body component and configured to couple the at least one latch member to the body component. 
     
     
         32 . The method of  claim 31 , wherein the at least one retention plate comprises a latching component configured to couple the controller assembly to the cartridge assembly. 
     
     
         33 . The method of  claim 28 , wherein the bias assembly comprises:
 a first biasing member having a first force profile; and   a second biasing member having a second force profile, wherein the first force profile is different than the second force profile,   wherein in the first position of the plunger component, the first and second biasing members apply the first and second forces profiles, respectively, to the plunger component to define a first stage profile comprising of the two stage force profile, and wherein in the second position of the plunger component, the first biasing member is prevented from applying the first force profile to the plunger component, the second biasing member applying the second force profile to the plunger component to define a second stage of the two stage force profile.   
     
     
         34 . The method of  claim 33 , wherein at least one of the first and second biasing members comprises a coil spring. 
     
     
         35 . The method of  claim 28 , wherein the body component comprises an annular inner portion having an annular wall defining a threaded portion defined therein. 
     
     
         36 . The method of  claim 35 , wherein the controller assembly further comprises a threaded adjustment member configured to adjust an amount of force applied by the bias assembly to the plunger component, wherein the bias assembly further comprises:
 an insert component having a hole defined therethrough;   a tube member extending through the hole;   a threaded body extending through the tube member, the treaded body having a head portion and an end portion; and   a threaded component configured to couple to the end portion of the threaded body extending through the insert component,   wherein a first biasing member is captured between the head portion of the threaded body and the inset component, wherein a second biasing member is captured between the insert component and the plunger component, and wherein the insert component is seated against the threaded adjustment member.   
     
     
         37 . The method of  claim 28 , wherein the medicament is selected from the group consisting of aspirin, ibuprofen, acetaminophen, sumatriptan, rizatriptan, almotriptan, naratriptan, zolmitriptan, frovatriptan and eletriptan. 
     
     
         38 . The method of  claim 28 , wherein the medicament is sumatriptan. 
     
     
         39 . The method of  claim 38 , wherein the flow rate of the fluid delivery apparatus is such that a C max  of the sumatriptan is in a range of from about 60 to 100 ng/mL. 
     
     
         40 . The method of  claim 38 , wherein the flow rate of the fluid delivery apparatus is such that a C ss  of the sumatriptan is in a range of from about 30 to 60 ng/mL. 
     
     
         41 . The method of  claim 38 , wherein the flow rate of the fluid delivery apparatus is such that a T max  of the sumatriptan is 30 minutes or less. 
     
     
         42 . The method in accordance with  claim 38 , wherein the flow rate of the fluid delivery apparatus is such that an AUC ∞  of the sumatriptan is greater than 9,000 ng·min/mL.