Multi-chamber, Multi-formulation Fluid Delivery System

Abstract

The application discloses a multi-chamber, multi-formulation fluid delivery system, comprising a multi-chamber applicator in fluid communication with multi-chamber packaging. Applicators according to the instant disclosure have reduced squeeze-strength requirements, and are useful for dispensing fluids, including medicaments, to animals, including livestock animals. The multi-chamber packaging provides separate storage for formulations containing incompatible active ingredients, and is suitable for use with the multi-chamber applicator. The application also discloses methods for using the system to simultaneously deliver multiple active ingredients, at least some of which are not suitable for co-formulation, thus reducing the time, economic burden and animal stress involved with applying multiple, separate formulations to animals.

What is claimed is: 
     
         1 . A multi-chamber, multi-formulation delivery system comprising:
 a. a multi-chamber applicator for delivering multiple formulations to an animal;   b. a suitable conduit and connectivity for connecting the applicator to fluid packaging; and   c. a multi-chamber packaging for separately containing and storing the multiple formulations.   
     
     
         2 . The system of  claim 1  wherein the applicator comprises:
 a. at least two fluid supply inlets; 
 b. at least one outlet; 
 c. at least two barrels each having barrel outlets and barrel inlets which are in fluid communication, or selective fluid communication, with the fluid supply inlets; 
 d. at least two one way outlet valves, one for each barrel, in fluid communication with the barrel outlets and with the outlets; 
 e. at least two pistons, one for each barrel, moveable relative to the barrels and in sealing engagement with the barrels; 
 f. a piston actuation means for moving the pistons relative to the barrels; 
 g. at least two pressure limiting means for limiting a maximum pressure of fluid entering the barrels from the fluid supply inlets; and optionally 
 h. a means for combining the fluids from the at least two barrels into a single outlet. 
 
     
     
         3 . The system of  claim 1 , wherein the applicator ( 200 ) is substantially as depicted in  FIGS. 3A -3F or  FIG. 4 . 
     
     
         4 . The system of  claim 3 , comprising:
 a. a first barrel ( 1   a ) with an outlet ( 2   a );   b. a one way outlet valve ( 3   a ), positioned at or adjacent the barrel outlet ( 2   a ), which is in selective fluid communication with an applicator outlet ( 4 ) from which fluid is discharged in use;   c. a second barrel ( 1   b ) with an outlet ( 2   b );   d. a one way outlet valve ( 3   b ), positioned at or adjacent the barrel outlet ( 2   b ), which is in selective fluid communication with the applicator outlet ( 4 ) from which fluid is discharged in use.   
     
     
         5 . The system of  claim 1  or  2 , wherein the application ( 203 ) is substantially as depicted in  FIGS. 14A-14C or 15A-15D , and comprises:
 a. a double barrel ( 12 ); 
 b. a left-hand plunger ( 30 ) and a right-hand plunger ( 29 ); 
 c. a means for independently actuating the plungers; 
 d. front ( 1 ) and rear ( 5 ) handles; 
 e. a volume control or dose adjuster means ( 11 ); 
 f. at least two BREAZE™ valve assemblies, wherein each BREAZE™ valve assembly comprises a fluid inlet ( 13 ), a BREAZE™ valve housing ( 14 ), a diaphragm ( 15 ), an inlet valve ( 16 ), an inlet valve retention pin ( 17 ), a clamp ring ( 18 ), a follower ( 19 ), a jumper washer ( 20 ), a spring ( 21 ), and a jet ( 22 ); and 
 g. a nozzle assembly. 
 
     
     
         6 . The system of  claim 5 , wherein the volume control comprises the following elements:
 a. ribs at the front of the volume control ( 11 ), providing a grip for turning the volume control;   b. two cylindrical shell spiral staircases, wrapped around and forming the outer surface of the volume control; wherein the two staircases have different diameters, and are offset axially, such that the inner (and slightly rearward) staircase engages with a rib on the left-hand plunger shaft ( 30 ), limiting how far forward this plunger shaft can travel; and wherein the outer (and slightly forward) staircase engages with a rib on the right-hand plunger shaft ( 29 ), limiting how far forward this plunger shaft can travel.   
     
     
         7 . The system of  claim 6 , wherein the ribs on the plunger shafts ( 29 ,  30 ) extend radially inwards by different lengths, determining with which spiral staircase each of them engages. 
     
     
         8 . The system of  claim 7 , wherein the axial positions of these ribs on the plunger shafts differ between the left and right plunger shafts ( 29 ,  30 , such that the two plunger shafts ( 29 ,  30 ) have the same axial position when in their forward position against the spiral staircases, despite engaging with opposite sides of the volume control ( 11 ). 
     
     
         9 . The system of  claim 5 , wherein the plunger shafts ( 29 ,  30 ) slidably engage with the inside of a housing ( 7 ), one on each side; and wherein a vertical groove, near the front of the plunger shaft ( 29 ,  30 ) engages with a plunger engagement pin ( 2 ), so that the plunger shaft is moved when the front handle ( 1 ) moves or is otherwise squeezed. 
     
     
         10 . The system of  claim 9 , wherein the part of the plunger shaft in front of the vertical groove protrudes outwards, to prevent a plunger engagement pin ( 2 ) from moving forward of the vertical groove, even when the pin is in the retracted position; and wherein the plunger engagement pin ( 2 ) can be retracted and then slide back along the side of the plunger shaft ( 29 ,  30 ), but not forward of it. 
     
     
         11 . The system of  claim 10 , wherein the two plunger shafts ( 29 ,  30 ) are not identical; and wherein the plungers' inwardly protruding ribs, which engage with the volume control ( 11 ) are different lengths radially and in different positions longitudinally; to ensure that each plunger engages with the correct spiral on the volume control ( 11 ), and both plunger shafts ( 29 ,  30 ) stop in the same longitudinal position despite engaging with opposite sides of the volume control ( 11 ). 
     
     
         12 . The system of  claim 1  or  2 , further comprising color-coded conduits that connect the multi-chamber applicator to the multi-chamber packaging, at corresponding color-coded caps; and anti-counterfeiting measures, substantially as depicted in  FIGS. 23A-B . 
     
     
         13 . A dose control, for use with the system of any one of  claim 1 ,  2  or  6 , comprising:
 a. ribs at the front of the volume control ( 11 ), providing a grip for turning the volume control; 
 b. two cylindrical shell spiral staircases, wrapped around and forming the outer surface of the volume control; wherein the two staircases have different diameters, and are offset axially, such that the inner (and slightly rearward) staircase engages with a rib on the left-hand plunger shaft ( 30 ), limiting how far forward this plunger shaft can travel; and wherein the outer (and slightly forward) staircase engages with a rib on the right-hand plunger shaft ( 29 ), limiting how far forward this plunger shaft can travel. 
 
     
     
         14 . The dose control of  claim 13 , substantially as depicted in  FIG. 17A-B . 
     
     
         15 . A multi-chamber applicator ( 203 ), for use with the system of  claim 1  or  6 , comprising:
 a. a double barrel ( 12 ); 
 b. a left-hand plunger ( 30 ) and a right-hand plunger ( 29 ); 
 c. a means for independently actuating the plungers; 
 d. front ( 1 ) and rear ( 5 ) handles; 
 e. a volume control or dose adjuster means ( 11 ); 
 f. at least two BREAZE™ valve assemblies, wherein each BREAZE™ valve assembly comprises a fluid inlet ( 13 ), a BREAZE™ valve housing ( 14 ), a diaphragm ( 15 ), an inlet valve ( 16 ), an inlet valve retention pin ( 17 ), a clamp ring ( 18 ), a follower ( 19 ), a jumper washer ( 20 ), a spring ( 21 ), and a jet ( 22 ); and 
 g. a nozzle assembly. 
 
     
     
         16 . The applicator ( 203 ) of  claim 15 , comprising: a front handle ( 1 ), a rear handle ( 5 ), a thread insert ( 6 ), a housing ( 7 ), a thread insert ( 8 ), a volume control or Dose adjuster ( 11 ), a barrel component ( 12 ), a fluid inlet ( 13 ), a BREAZE™ valve housing ( 14 ), a diaphragm ( 15 ), an inlet valve ( 16 ), an inlet valve retention pin ( 17 ), a clamp ring ( 18 ), a plunger shaft (right hand side) ( 29 ), a plunger shaft (left hand side) ( 30 ), an outlet adaptor ( 31 ), an outlet tube connector ( 32 ), a nozzle ( 33 ), an umbrella valve ( 36 ), a handle spring ( 40 ), an outlet tube ( 45 ); and wherein the parts are arranged according to  FIGS. 15A-15D . 
     
     
         17 . The applicator ( 203 ) of  claim 16 , comprising: a front handle ( 1 ), a plunger engagement pin ( 2 ), a spring ( 3 ), a knob ( 4 ), a rear handle ( 5 ), a thread insert ( 6 ), a housing ( 7 ), a thread insert ( 8 ), a pivot pin (male) ( 9 ), a pivot pin (female) ( 10 ), a volume control or Dose adjuster ( 11 ), a barrel component ( 12 ), a fluid inlet ( 13 ), a BREAZE™ valve housing ( 14 ), a diaphragm ( 15 ), an inlet valve ( 16 ), an inlet valve retention pin ( 17 ), a clamp ring ( 18 ), a follower ( 19 ), a jumper washer ( 20 ), a spring ( 21 ), a jet ( 22 ), a plug ( 23 ), an O-ring seal ( 24 ), a rear cover ( 25 ), a plunger head ( 26 ), a plunger O-ring ( 27 ), a felt washer ( 28 ), a plunger shaft (right hand side) ( 29 ), a plunger shaft (left hand side) ( 30 ), an outlet adaptor ( 31 ), an outlet tube connector ( 32 ), a nozzle ( 33 ), gaskets ( 34 ), an outlet valve seat ( 35 ), an umbrella valve ( 36 ), a nozzle rose ( 37 ), a nut ( 38 ), tie rods ( 39 ), a handle spring ( 40 ), an elbow adaptor ( 41 ), an O-ring seal ( 42 ), an O-ring seal ( 43 ), an O-ring retainer ( 44 ), an outlet tube ( 45 ), and screws ( 46 ); and wherein the parts are arranged according to  FIGS. 15A-15D . 
     
     
         18 . The applicator of  claim 15 , comprising a split nozzle assembly, substantially as depicted in  FIG. 18A-B . 
     
     
         19 . The applicator of  claim 15 , comprising a rose nozzle assembly, substantially as depicted in  FIG. 19A-B . 
     
     
         20 . A multi-chamber packaging for use with the system of  claim 1  or  claim 2 , comprising: at least two independent reservoirs, fluidly connectable to an applicator described in  claim 15 . 
     
     
         21 . The packaging of  claim 20 , substantially as depicted in  FIGS. 6A-B ,  7 ,  8 ,  9 ,  10  or  11 . 
     
     
         22 . A harness for allowing a user to comfortably wear and use the system of  claim 1  or  2 , wherein the harness is substantially as depicted in  FIGS. 12, 13, 20A -B,  21 A-B or  22 A-B. 
     
     
         23 . A method for simultaneously administering to an animal in need thereof multiple active ingredient formulations comprising:
 a. connecting a multi-chamber applicator according to  claim 15  to a multi-chamber packaging containing in each of its chambers a separate formulation;   b. loading or priming the multi-chamber applicator with the separate formulations; and   c. actuating the applicator to dispense the formulations onto or into the animal thereby administering the active ingredients.   
     
     
         24 . The method of  claim 23 , wherein at least one of the formulations contain at least one active ingredient which cannot easily be co-formulated with the other active ingredients, which are present in another formulation. 
     
     
         25 . The method of  claim 23 , wherein there is no known stable and effective co-formulation of the active ingredients. 
     
     
         26 . The method of  claim 23 , wherein the simultaneous administration provides a stronger or synergistic effect, when compared to the effect achieved when the one or more formulations are administered via separate applications. 
     
     
         27 . The method of  claim 23 , wherein one incompatible active ingredient is fipronil and the other incompatible active ingredient is amitraz. 
     
     
         28 . The method of  claim 23 , wherein the simultaneous administration of fipronil and amitraz has a stronger or synergistic pesticidal effect as compared to a separate administration of fipronil and amitraz. 
     
     
         29 . The method of  claim 28 , wherein the stronger effect is extended duration of efficacy against acarids. 
     
     
         30 . The method of  claim 28 , wherein the stronger effect is more rapid killing efficacy against acarids. 
     
     
         31 . The method of  claim 28 , wherein the stronger effect is reduced development of pesticide resistance.