JP2022542893A - rotary metering pump for insulin patch - Google Patents

Abstract

A rotary pump (4000) for a fluid metering system is provided. The rotary pump reciprocates and is reversed by a signal from a limit switch (4506) biased by an actuator arm (4508) on the rotary sleeve (4500) of the pump system. Rotary pump (4000) includes plunger (5210) and optional stopper (5206) formed from a two-shot molding process, head (5212) of plunger (5210) and head (5208) of optional stopper (5206). It includes a seal (5214) overmolded thereon.

Description

The presently disclosed invention relates generally to metering systems for use with wearable drug infusion patches.

Diabetes is a group of diseases characterized by high blood sugar levels due to defects in insulin production, insulin action, or both. Diabetes can lead to serious health complications and premature death, but there are well-known products available to people with diabetes to help control the disease and reduce the risk of complications. Existing.

Treatment options for diabetics include special diets, oral medications, and/or insulin therapy. A major goal of diabetes treatment is to control a patient's blood glucose levels in order to increase their chances of a complication-free life. However, achieving good diabetes management while balancing other life demands and circumstances is not always easy.

Currently, there are two main modes of daily insulin therapy for the treatment of type 1 diabetes. The first mode includes syringes and insulin pens, and the first mode generally requires puncturing with each injection, three to four times per day. These devices are simple to use and relatively inexpensive. Another widely applicable and effective method of treatment for managing diabetes is the use of insulin pumps. Because insulin pumps more closely mimic the behavior of the pancreas, insulin pumps provide a continuous infusion of insulin at varying rates, allowing users to keep their individual blood glucose levels within target ranges based on their individual needs. can help keep. Using an insulin pump allows users to tailor their individual insulin regimens to their individual lifestyles, rather than individual lifestyles to how insulin injections work for them. .

However, conventional insulin pumps suffer from several drawbacks. For example, the lead screw and piston type metering systems used in typical insulin pumps require a large height and a large footprint and are often cumbersome for users.

Conventional insulin pumps also typically require a large number of components and moving parts, which also increases the risk of mechanical failure.

Also, conventional insulin pumps generally have a tolerance loop that is too long for dose accuracy, relying on too many factors that can be difficult to ascertain. This can result in a loss in dose precision.

Also, conventional insulin pumps typically have fluid paths that are too complicated. This can result in complex or inadequate priming and air removal.

Also, conventional insulin pumps typically require highly accurate actuators, which increases the cost of conventional patch pumps.

Some insulin pumps also risk creating a direct fluid path between the reservoir and the cannula within the insulin patch. This can result in overdosing the user.

Also, conventional insulin pumps typically require complex sensing schemes. This can result in increased costs and reduced accuracy and reliability.

Also, conventional insulin pumps typically have valves that are leaky at elevated system backpressures. This can result in reduced accuracy and reliability.

Also, conventional insulin pumps generally require large working volumes and large system volumes that are subject to potentially high back pressures. This can result in reduced accuracy and reliability.

Also, conventional insulin patches typically have low efficiency motors that require large batteries, thereby increasing the size of the insulin patch.

Accordingly, there is a need for a metering system that has a reduced height and footprint compared to conventional lead screw and piston type metering systems to increase comfort for the user.

There is also a need for a metering system that has a reduced number of components and moving parts compared to conventional insulin pumps to increase the mechanical safety of insulin patches.

There is also a need for a metering system that has a shorter tolerance loop for dependent dose accuracy compared to conventional metering pumps, thereby increasing dose accuracy.

There is also a need for a metering system that has a simpler fluid path as compared to conventional metering systems, thereby simplifying priming and air removal.

There is also a need for metering systems that utilize less accurate actuators compared to conventional metering systems, thereby reducing the cost of insulin patches.

There is also a need for a metering system that does not have a direct fluid path between the reservoir and the cannula as compared to conventional metering systems, thereby better protecting the user from overdosing.

There is also a need for a metering system that has a simple sensing scheme compared to conventional metering systems, thereby reducing cost and increasing accuracy and reliability of insulin patches.

There is also a need for a metering system that has valves that are robust with respect to leakage at elevated system backpressures, as compared to conventional metering systems, thereby increasing the accuracy and reliability of insulin patches.

There is also a need for a metering system that has a small working volume and a low system volume subject to potentially high back pressure, compared to conventional metering systems, thereby increasing the accuracy and reliability of insulin patches. there is

There is also a need for a metering system that requires a highly efficient motor with a small battery compared to conventional metering systems, thereby reducing the size of insulin patches.

It is an aspect of exemplary embodiments of the presently disclosed invention to substantially address the above and other concerns and to provide a compact and reliable weighing system.

An aspect of the exemplary embodiments of the presently disclosed invention provides a metering system with a reduced height and footprint compared to conventional lead screw and piston type metering systems, resulting in increased comfort for the user. is to increase

Another aspect of the exemplary embodiments of the presently disclosed invention is a metering device with a reduced number of components and moving parts compared to conventional insulin pumps to increase the mechanical safety of the insulin patch. It is to provide a system.

Another aspect of the exemplary embodiments of the presently disclosed invention provides a metering system having a short tolerance loop with less factor dependent dose accuracy compared to conventional metering pumps, thereby It is to increase accuracy. For example, in exemplary embodiments of the disclosed invention, the dose accuracy tolerance loop is short and depends only on two easily measurable dimensions: the diameter of the pump and the axial dimension of the helical slot.

Another aspect of the exemplary embodiments of the presently disclosed invention is to provide a metering system with simple fluid paths, thereby simplifying priming and air removal, as compared to conventional metering systems. be.

Another aspect of the exemplary embodiments of the presently disclosed invention is to provide a metering system that utilizes less accurate actuators, thereby reducing the cost of insulin patches compared to conventional metering systems. be. For example, in exemplary embodiments of the presently disclosed invention, the mechanism can over-rotate at both ends of the stroke and still maintain dose accuracy.

Another aspect of the exemplary embodiments of the presently disclosed invention provides a metering system that does not have a direct fluid path between the reservoir and the cannula, as compared to conventional metering systems, thereby allowing the user to It is to provide safer protection against overdose.

Another aspect of the exemplary embodiments of the presently disclosed invention is to provide a metering system with a simple sensing scheme, thereby reducing cost, accuracy and accuracy of insulin patches as compared to conventional metering systems. It is to increase reliability. For example, in exemplary embodiments of the disclosed invention, the sensing scheme is based on contact switches.

Another aspect of the exemplary embodiments of the presently disclosed invention is to provide a metering system that allows the mechanical stroke of the pump to be a simple actuation of the cannulation mechanism.

Another aspect of the exemplary embodiments of the presently disclosed invention is that they are robust with respect to leakage at elevated system back pressures compared to conventional metering systems, thereby increasing insulin patch accuracy and reliability. Another object of the present invention is to provide a metering system having a valve that allows For example, in exemplary embodiments of the presently disclosed invention, valves do not have volume changes when transitioning between states.

Another aspect of the exemplary embodiments of the presently disclosed invention provides a metering system that has a small working volume and a low system volume that is subject to potentially high back pressure as compared to conventional metering systems. , thereby increasing the accuracy and reliability of insulin patches.

Another aspect of the exemplary embodiments of the presently disclosed invention provides a metering system that uses a high efficiency motor with a small battery, thereby reducing the size of the insulin patch compared to conventional metering systems. It is to be.

These and/or other aspects of the disclosed invention are accomplished by providing a metering system for use in a wearable insulin infusion patch. For example, in an exemplary embodiment of the presently disclosed invention, the metering system includes a larger fluidics system that includes a flexible reservoir for storing insulin and a cannula assembly for delivering insulin to subcutaneous tissue. Part of a subsystem. The metering system withdraws a small amount of fluid from the reservoir and then pushes it down the cannula line and into the patient. The fluid dose is small relative to the reservoir volume such that many pump strokes are required to completely empty the reservoir.

Additional and/or other aspects and advantages of the disclosed invention will be set forth in the following description, or may be apparent from the description, or may be learned by practice of the invention. Inventions according to the present disclosure may comprise methods or devices or systems having one or more of the above aspects and/or features and combinations thereof. Inventions according to the present disclosure may comprise and comprise one or more of the features and/or combinations of the above aspects, for example as set forth in the appended claims.

Various objects, advantages and novel features of the exemplary embodiments of the present invention will be more readily understood by reading the following detailed description in conjunction with the accompanying drawings.
FIG. 10 illustrates the structure of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 10 illustrates a layout of fluid and metering system components of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; 1 is a schematic exploded view of a metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. FIG. 12 illustrates the layout of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; 1 is a schematic cross-sectional view of a metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in the starting position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in the starting position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump during an inhalation stroke, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump during an inhalation stroke, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump according to the invention of the present disclosure during a valve state change after an intake stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump according to the invention of the present disclosure during a valve state change after an intake stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump according to the invention of the present disclosure during a valve state change after an intake stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in an inspiratory transition stop position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in an inspiratory transition stop position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump during the exhaust stroke, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump during the exhaust stroke, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure during a valve state change after an exhaust stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure during a valve state change after an exhaust stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure during a valve state change after an exhaust stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure after completion of a pump cycle; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure after completion of a pump cycle; 1 is an exploded view of a metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 1 is a schematic exploded view of a pump assembly of an exemplary embodiment of a metering pump in accordance with the invention of the present disclosure; FIG. 1 is a schematic exploded view of a motor and gearbox assembly of an exemplary embodiment of a metering pump in accordance with the invention of the present disclosure; FIG. FIG. 10 is a plurality of schematic diagrams showing how the piston is assembled into the sleeve according to the invention of the present disclosure; FIG. 10 is a plurality of schematic diagrams showing how the piston is assembled into the sleeve according to the invention of the present disclosure; FIG. 10 is a plurality of schematic diagrams showing how the piston is assembled into the sleeve according to the invention of the present disclosure; FIG. 10 is a plurality of schematic diagrams showing how the piston is assembled into the sleeve according to the invention of the present disclosure; Fig. 10 is a plurality of schematic diagrams showing how the plug is assembled into the sleeve according to the invention of the present disclosure; Fig. 10 is a plurality of schematic diagrams showing how the plug is assembled into the sleeve according to the invention of the present disclosure; Fig. 10 is a plurality of schematic diagrams showing how the plug is assembled into the sleeve according to the invention of the present disclosure; [0014] Fig. 5 is a plurality of schematic diagrams showing how the sleeve is assembled into the manifold in accordance with the presently disclosed invention; [0014] Fig. 5 is a plurality of schematic diagrams showing how the sleeve is assembled into the manifold in accordance with the presently disclosed invention; [0014] Fig. 5 is a plurality of schematic diagrams showing how the sleeve is assembled into the manifold in accordance with the presently disclosed invention; [0014] Fig. 5 is a plurality of schematic diagrams showing how the sleeve is assembled into the manifold in accordance with the presently disclosed invention; 1 is a schematic cross-sectional view of a pump assembly of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 4A-4D are a plurality of schematic cross-sectional views illustrating valve state changing methods in accordance with the present disclosure; 4A-4D are a plurality of schematic cross-sectional views illustrating valve state changing methods in accordance with the present disclosure; 4A-4D are a plurality of schematic cross-sectional views illustrating valve state changing methods in accordance with the present disclosure; 4A-4D are a plurality of schematic cross-sectional views illustrating valve state changing methods in accordance with the present disclosure; 4A-4D are a plurality of schematic cross-sectional views illustrating valve state changing methods in accordance with the present disclosure; FIG. 10 is a plurality of views of limit switches for pump and sleeve rotation in the metering subsystem of an exemplary embodiment of a patch pump in accordance with the present disclosure; 10A-10B are multiple views of limit switches for pump and sleeve rotation in the metering subsystem of an exemplary embodiment of a patch pump in accordance with the presently disclosed invention; 10A-10B are multiple views of limit switches for pump and sleeve rotation in the metering subsystem of an exemplary embodiment of a patch pump in accordance with the presently disclosed invention; Fig. 10 is a plurality of schematic cross-sectional views showing how a pump according to the invention of the present disclosure can be incorporated into a gearbox; 4A-4D are a plurality of schematic cross-sectional views showing how a pump according to the presently disclosed invention can be incorporated into a gearbox; 4A-4D are a plurality of schematic cross-sectional views showing how a pump according to the presently disclosed invention can be incorporated into a gearbox; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in the starting position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in the starting position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in the starting position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump during the exhaust stroke, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump during the exhaust stroke, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure during a valve state change after an exhaust stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure during a valve state change after an exhaust stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure during a valve state change after an exhaust stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in an exhaust rotation stop position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in an exhaust rotation stop position, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump during an inhalation stroke, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump during an inhalation stroke, in accordance with the invention of the present disclosure; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump according to the invention of the present disclosure during a valve state change after an intake stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump according to the invention of the present disclosure during a valve state change after an intake stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump according to the invention of the present disclosure during a valve state change after an intake stroke; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure in a suction rotation stop position; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure in a suction rotation stop position; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure after completion of a pump cycle; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure after completion of a pump cycle; 4A-4D are multiple views of the metering subsystem of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure after completion of a pump cycle; FIG. 10 is a plurality of views of an exemplary embodiment of a metering pump with a motor and gearbox assembly and a modified pump assembly in accordance with the invention of the present disclosure; FIG. 10 is a plurality of views of an exemplary embodiment of a metering pump with a motor and gearbox assembly and a modified pump assembly in accordance with the invention of the present disclosure; FIG. 10 is a plurality of views of an exemplary embodiment of a metering pump with a motor and gearbox assembly and a modified pump assembly in accordance with the invention of the present disclosure; FIG. 4 is an exploded view of a pump assembly of an exemplary embodiment of a metering assembly in accordance with the invention of the present disclosure; FIG. 10 illustrates the incorporation of the piston into the sleeve of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 10 illustrates the incorporation of the piston into the sleeve of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 12 illustrates the incorporation of the sleeve into the manifold of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 12 illustrates the incorporation of the sleeve into the manifold of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 12 illustrates the incorporation of the sleeve into the manifold of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 12 illustrates the incorporation of the sleeve into the manifold of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 12 illustrates the incorporation of the sleeve into the manifold of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 10 is a cross-sectional view of the sleeve and manifold assembly of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 10 is a multiple cross-section showing valve state changes of an exemplary embodiment of a patch pump in accordance with the presently disclosed invention as the sleeve rotates. FIG. 10 is a multiple cross-section showing valve state changes of an exemplary embodiment of a patch pump in accordance with the presently disclosed invention as the sleeve rotates. FIG. 10 is a multiple cross-section showing valve state changes of an exemplary embodiment of a patch pump in accordance with the presently disclosed invention as the sleeve rotates. FIG. 10 illustrates a sleeve rotation limit switch of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 10 illustrates a sleeve rotation limit switch of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 10 illustrates a sleeve rotation limit switch of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 10 illustrates a sleeve rotation limit switch of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 4 is an exploded view of the pump assembly of an exemplary embodiment of a patch pump with elastomeric ports and piston seals overmolded onto the manifold and pump piston, respectively, in accordance with the presently disclosed invention; FIG. 4 is an exploded view of the pump assembly of an exemplary embodiment of a patch pump with elastomeric ports and piston seals overmolded onto the manifold and pump piston, respectively, in accordance with the presently disclosed invention; FIG. 4 is an exploded view of a pump assembly having an alternative rotational limit switch design of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 4 is an exploded view of a pump assembly having an alternative rotational limit switch design of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 4 is an exploded view of a pump assembly having an alternative rotational limit switch design of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; FIG. 4 is an exploded view of a pump assembly having an alternative rotational limit switch design of an exemplary embodiment of a patch pump in accordance with the invention of the present disclosure; 1 is an exploded view of an exemplary embodiment of a weigh assembly in accordance with the invention of the present disclosure; FIG. Figure 41 is an assembled view of the weigh assembly of Figure 40; Figure 41 shows a cross-section of the weigh assembly of Figure 40; 41 is an exemplary embodiment showing the interaction of the sleeve and interlock of the weigh assembly of FIG. 40 in accordance with the presently disclosed invention; FIG. 41 is an exemplary embodiment showing the interaction of the sleeve and interlock of the weigh assembly of FIG. 40 in accordance with the presently disclosed invention; FIG. 41 is an exemplary embodiment showing the interaction of the sleeve and interlock of the weigh assembly of FIG. 40 in accordance with the presently disclosed invention; FIG. FIG. 10 is a cross-sectional view of another exemplary embodiment of a weigh assembly in accordance with the invention of the present disclosure; FIG. 4 is an isometric view of a limit switch and actuator arm useful in alternative exemplary embodiments of the disclosed invention; 46 is an isometric view of a limit switch and rotating sleeve according to the embodiment of FIG. 45; FIG. 46 is a top view of the limit switch of FIG. 45; FIG. 46 is a top view of the limit switch and actuator arm of FIG. 45; FIG. 47 is an end view of the rotating sleeve of FIG. 46; FIG. Figure 46 is a cross-sectional elevational view of the limit switch and actuator arm of Figure 45; 4 is a chart showing relative displacement of a limit switch and a rotating sleeve according to an exemplary embodiment of the invention; 4 is a chart showing relative displacement of a limit switch and a rotating sleeve according to an exemplary embodiment of the invention; FIG. 4 is a different perspective view of an improved plunger for a pump according to another exemplary embodiment of the present invention; FIG. 4 is a different perspective view of an improved plunger for a pump according to another exemplary embodiment of the present invention; FIG. 4 is a different perspective view of an improved plunger for a pump according to another exemplary embodiment of the present invention; FIG. 4 is a different perspective view of an improved plunger for a pump according to another exemplary embodiment of the present invention; FIG. 4 is a different perspective view of an improved plunger for a pump according to another exemplary embodiment of the present invention; FIG. 4 is a different perspective view of an improved plunger for a pump according to another exemplary embodiment of the present invention; FIG. 4 is a different perspective view of an improved plunger for a pump according to another exemplary embodiment of the present invention; 59 is a different perspective view of an overmolded seal for the improved plunger of FIGS. 52-58; FIG. 59 is a different perspective view of an overmolded seal for the improved plunger of FIGS. 52-58; FIG. 59 is a different perspective view of an overmolded seal for the improved plunger of FIGS. 52-58; FIG. 59 is a different perspective view of an overmolded seal for the improved plunger of FIGS. 52-58; FIG. Fig. 10 is a different perspective view of the improved pump plug; Fig. 10 is a different perspective view of the improved pump plug; Fig. 10 is a different perspective view of the improved pump plug; Fig. 10 is a different perspective view of the improved pump plug; Fig. 10 is a different perspective view of the improved pump plug; FIG. 4 is an exploded view of a pump system utilizing the improved plunger, plug and overmolded seal of an exemplary embodiment of the present invention; 4 is a flowchart of a method of manufacturing a pump according to an exemplary embodiment of the invention;

Like reference numbers should be understood to refer to like elements, features and structures throughout the drawings.

As will be appreciated by those of ordinary skill in the art, there are many ways to implement examples, modifications and arrangements of metering systems according to the embodiments of the present disclosure disclosed herein. Reference will be made to the exemplary embodiments illustrated in the drawings and the following description, but the embodiments disclosed herein are not exhaustive of the various alternative designs and embodiments encompassed by the disclosed invention; Those skilled in the art will readily appreciate that various modifications can be made and various combinations can be made without departing from the invention.

Although various persons, including but not limited to patients or health care professionals, can operate or use the exemplary embodiments of the presently disclosed invention, for the sake of brevity, the following will be referred to as an operator or A user is called a "user".

Although a variety of fluids may be used in exemplary embodiments of the disclosed invention, for the sake of brevity, the liquid within the injection device will hereinafter be referred to as the "fluid."

Exemplary embodiments in accordance with the presently disclosed invention are depicted in FIGS. 1-30. In an exemplary embodiment according to the presently disclosed invention, a metering system is provided for use with a wearable insulin infusion patch. For example, in an exemplary embodiment of the presently disclosed invention, the metering system includes a larger fluidics system that includes a flexible reservoir for storing insulin and a cannula assembly for delivering insulin to subcutaneous tissue. Part of a subsystem. The metering system withdraws a small amount of fluid from the reservoir and then pushes it down the cannula line and into the patient. The fluid dose is small relative to the reservoir volume such that many pump strokes are required to completely empty the reservoir.

FIG. 1 shows the construction of a patch pump 100 according to an exemplary embodiment of the invention according to this disclosure. Patch pump 100 includes fluidics subsystem 120 , electronics subsystem 140 , and power storage subsystem 160 .

Fluidics subsystem 120 includes fill port 122 in fluid communication with reservoir 124 . Reservoir 124 is adapted to receive fluid from the syringe through the fill port.

Fluidics subsystem 120 further includes volume sensor 126 mechanically coupled to reservoir 124 . Volume sensor 126 is adapted to detect or determine the fluid volume of the reservoir.

Fluidics subsystem 120 further includes metering subsystem 130 , which includes integrated pump and valve system 132 mechanically coupled to pump and valve actuator 134 . Integrated pump and valve system 132 is in fluid communication with reservoir 124 of fluidics subsystem 120 and is actuated by pump and valve actuator 134 .

Fluidics subsystem 120 further includes a cannula mechanism having deployment actuator 128 mechanically coupled to cannula 129 . Deployment actuator 128 is adapted to insert cannula 129 into the user. Cannula 129 is in fluid communication with integrated pump and valve system 132 of metering subsystem 130 .

Fluidics subsystem 120 further includes occlusion sensor 136 mechanically coupled to the fluid path between cannula 129 and integrated pump and valve system 132 . Occlusion sensor 136 is adapted to detect or determine an occlusion in the pathway between cannula 129 and integrated pump and valve system 132 .

Electronics subsystem 140 includes volume sensing electronics 142 electrically coupled to volume sensor 126 of fluidics subsystem 120 and pump and valve controllers electrically coupled to pump and valve actuators 134 of metering subsystem 130 . 144 , occlusion sensing electronics 146 electrically coupled to occlusion sensor 136 of fluidics subsystem 120 , and optional deployment electronics 148 electrically coupled to cannula 129 of fluidics subsystem. Electronics subsystem 140 further includes microcontroller 149 electrically coupled to volume sensing electronics 142 , pump and valve controller 144 , occlusion sensing electronics 146 , and deployment electronics 148 .

Power storage subsystem 160 includes battery 162 or any other power source known in the art. Battery 162 may be adapted to power any component or electronic component of patch pump 100 .

FIG. 2 illustrates the layout of the fluid and metering system components of patch pump 200 in accordance with an exemplary embodiment of the presently disclosed invention. Patch pump 200 includes metering subsystem 230 , control electronics 240 , battery 260 , reservoir 222 , fill port 224 , and cannula mechanism 226 . Elements of patch pump 200 are substantially similar to elements of exemplary patch pump 100 that are referenced with like reference numerals and interact in substantially the same manner.

FIG. 3 is an exploded perspective view of a patch pump metering subsystem 300 in accordance with an exemplary embodiment of the presently disclosed invention. Metering subsystem 300 includes DC gear motor 302 mechanically coupled to pump piston 304 disposed within pump casing 306 . Pump piston 304 is mechanically coupled to pump housing 308 by coupling pin 310 . Metering subsystem 300 further includes pump seal 312 between pump piston 304 and pump housing 308 . Metering subsystem 300 further includes port seals 314 on seal carriage 316 disposed within valve housing 318 .

In exemplary embodiments of the disclosed invention, the DC gear motor output shaft 320 can rotate 360 degrees in either direction. The pump piston 304 can rotate 360 degrees in either direction and translate by approximately 0.050 inches. Pump housing 308 can be rotated 180 degrees in either direction. Pump casing 306, port seals 314, seal carriage 316, and valve housing 318 are preferably stationary.

Metering subsystem 300 includes a positive displacement pump with an integrated flow control valve and mechanical actuator and drive system. The pump includes a piston 304 and a rotationally actuated selector valve. A metering system draws a precise volume of insulin from a flexible reservoir into a pump volume 320 formed between a piston 304 and a pump housing 308 (see FIG. 5) and then dispenses this insulin volume through a cannula. The insulin is administered in small, discrete doses that drain into the patient's subcutaneous tissue. A pump stroke creates positive and negative pressure gradients in the fluid path, inducing flow. The stroke and inner diameter of the pump volume determine the dose accuracy and nominal size. The fluid control valve actively shuttles between the fluid ports of the reservoir and cannula at each end of the pump stroke, alternately closing and opening the ports to provide unidirectional fluid flow (reservoir to patient), and Ensure that no free flow can occur with the patient.

FIG. 4 is an assembled view of weighing subsystem 300 in accordance with an exemplary embodiment of the invention of this disclosure. Also shown are a motor-to-piston connection 322, a piston-to-pump housing connection 324, a reservoir port 326 and a cannula report 328. FIG.

FIG. 5 is a cross-sectional view of a metrology subsystem 300 of an exemplary embodiment of the invention consistent with this disclosure. As shown, a pump volume 320 is formed between the piston and pump housing 308 . The pump housing includes a side port 330 that alternates in orientation between a reservoir port 326 and a cannula port 328 as motor 302 reciprocates the pump, as described in more detail below.

In operation, an exemplary cycle of a metering system according to the presently disclosed invention is 180 degree pump intake (counterclockwise) (when looking from pump to motor), 180 degree valve state change (counterclockwise). , 180 degree pumping (clockwise), and 180 degree valve state change (clockwise). A complete cycle requires a complete rotation (360 degrees) in each direction.

FIG. 6A is an isometric view and FIG. 6B is a cross-sectional view of weighing subsystem 300 in the starting position. In the starting position, the pump piston 302 is fully extended, the pump housing closes the cannula report flow path at the cannula report 328, the reservoir port 326 opens to the side port 330 of the pump housing 308, and the rotation limit sensor 332 is open. is engaged. Pump housing 308 includes a spiral groove 334 that receives coupling pin 310 . Piston 304 rotates within pump housing 308 (by the rotational force of motor 302 ), coupling pin 310 slides along helical groove 334 to move piston 304 axially relative to pump housing 308 . It is in sliding engagement with the pump housing 308 so as to allow it to translate inward. In this embodiment, a spiral groove 334 is formed in pump housing 308 to provide 180 degrees of rotation for coupling pin 310 .

7A is an isometric view and FIG. 7B is a cross-sectional view of metering subsystem 300 during the intake stroke. DC motor 302 rotates pump piston 304 which is driven (rotated and translated) along spiral groove 334 in pump housing 308 via coupling pin 310 . Pump piston 304 translates toward DC motor 302 drawing fluid into an increasing pump volume 320 . During the suction stroke, the friction between the seal and the outer diameter of pump housing 308 is preferably high enough to keep pump housing 308 from rotating. Pump housing 308 remains stationary while pump volume 320 expands. Cannula report 328 is closed, but reservoir port 326 is open to fluid entering expanding pump volume 320 . A sliding engagement exists between the motor 302 and the pump piston 304 .

8A is an assembly view, FIG. 8B is a detailed view, and FIG. 8C is a cross-sectional view of the patch pump during a valve state change after the intake stroke. Torque is transmitted from the drive shaft of motor 302 to pump piston 304 and through coupling pin 310 to pump housing 308 . Once coupling pin 310 has rotated to the end of helical groove 334 , further rotation of motor 302 causes coupling pin 310 to rotate pump housing 308 and pump piston 304 as one without relative axial translation. A side port 330 on pump housing 308 rotates between reservoir port 326 and cannula report 328 . Surface tension at side port 330 of pump housing 308 retains fluid within pump volume 320 . Pump housing side port 330 transitions out of alignment with reservoir port 326 and into alignment with cannula report 328 over the next 180 degree rotation of motor 302 . Meanwhile, both cannula report 328 and reservoir port 326 are closed. A coupling pin 310 is at the end of the helical groove 334 and transmits torque to the pump housing 308 . Coupling pin 310 locks pump piston 304 and pump housing 308 together to inhibit relative axial movement between the two components. Therefore, pump piston 304 and pump housing 308 rotate as a unit and do not translate relative to each other. Pump housing 308 rotates, pump volume 320 is fixed, and pump piston 304 rotates. Seal 314, seal carriage, and valve housing 318 are preferably stationary.

9A is an assembly view and FIG. 9B is a cross-sectional view of the metering subsystem in the inspiratory transition stop position ready to inject. As shown, side port 330 of pump housing 308 is aligned with cannula report 328, pump volume 320 is expanded, and reservoir port 326 is closed. A rotation limit sensor 332 is engaged by a mechanism on the rotation pump housing 308 . Motor 302, pump piston 304, and pump housing 308 are stationary.

10A is an assembly view and FIG. 10B is a cross-sectional view of weighing subsystem 300 during the ejection stroke. At the end of the intake stroke, pump housing 308 engages limit switch 332 which causes DC motor 302 to switch direction. The motor 302 thus rotates the piston 304 and drives the coupling pin 310 down the helical groove 334 of the pump housing 308 to axially translate the piston 304 . Pump piston 304 axially translates away from DC motor 302 and forces fluid from pump volume 320 out of cannula report 328 and into the cannula. During the exhaust stroke, the friction between seal 314 and the outer diameter of pump housing 308 is preferably high enough to ensure that pump housing 308 does not rotate. Cannula report 328 is open to fluid exiting collapsed pump volume 320 . Reservoir port 326 is closed. The pump housing 308 is stationary while the pump volume 320 is collapsing and the pump piston 304 is rotating and translating in a helical motion. A motor is slidably connected to the piston 304 and accommodates translational motion of the piston as it rotates within the helical groove 334 .

11A is an assembly view, FIG. 11B is a detailed view, and FIG. 11C is a cross-sectional view of metering subsystem 300 during a valve state change after an exhaust stroke. Torque is transmitted from the drive shaft of motor 302 to pump piston 304 and then to pump housing 308 via coupling pin 310 . Pump housing 308 and pump piston 304 rotate as a unit without relative axial motion. A side port 330 on the pump housing 308 rotates between the reservoir port 326 and the cannula report 328, both of which are closed during rotation. Surface tension at side port 330 of pump housing 308 retains fluid within pump volume 320 . Coupling pin 310 locks pump piston 304 and pump housing 308 together to inhibit relative axial movement between the two components. Therefore, pump piston 304 and pump housing 308 rotate as a unit and do not translate relative to each other. The pump volume 320 is fixed while the pump housing 308 rotates. Seal 314, seal carriage, and valve housing 318 are preferably stationary.

12A is an assembly view and FIG. 12B is a cross-sectional view of metering subsystem 300 after a pump cycle has been completed. The pump mechanism (piston 304) is fully extended, completing the pump cycle. Rotation limit sensor 332 is engaged to reverse motor 302 and restart the pump cycle. Cannula report 328 is closed while reservoir port 326 is open to flow from the reservoir.

In the exemplary embodiment described above, the pump piston both rotates and translates, the pump housing rotates, and the valve housing remains stationary. However, in other embodiments, the system may be configured such that the pump piston rotates, the pump housing both rotates and translates, the valve housing translates, or any other combination of movements that increase and decrease pump volume; It should also be appreciated that the port communicating with the pump volume may be configured to transition from alignment with the reservoir port to alignment with the cannula report.

In the exemplary embodiment described above, the pump stroke and valve state changes consist of 180 degree rotary actuation from the motor. However, it should be appreciated that any suitable angle may be selected for the segments of the pump cycle.

In the exemplary embodiment described above, there is an atmospheric blockage between the cannula report and the reservoir port during valve state changes. However, it is understood that in other embodiments, seals may be configured or additional seals may be added to eliminate atmospheric blockage and seal the pump and valve system during state changes. sea bream.

In the exemplary embodiment described above, DC gear motors are used to drive the pumps and valves. However, in other embodiments any suitable drive mechanism may be provided to drive the pumps and valves. For example, solenoids, nitinol wires, voice coil actuators, piezo motors, wax motors, and/or any other type of motor known in the art can be used to drive the pump.

In the exemplary embodiment described above, the pump uses a full exhaust stroke. However, it should be appreciated that in other embodiments, systems having increasingly increasing ejection strokes may be used to administer finer doses.

In the exemplary embodiment described above, the pump uses an on/off limit switch to determine the state of the system at the limits of rotational travel. However, it should be appreciated that other sensors capable of determining intermediate states, such as encoder wheels or optical sensors, may be used in other embodiments to improve the resolution of the sensing scheme.

It should be appreciated that the inner diameter of the pump may be adjusted to change the nominal power output per cycle.

In the exemplary embodiment described above, the pump uses elastomeric O-ring seals. However, it should be understood that other arrangements may also be used. For example, fluid seals may be molded directly onto the seal carriage, other elastomeric seals such as quad rings may be used, or other sealing materials such as Teflon or polyethylene lip seals may be used.

In alternate embodiments of the present invention, movement of the pump may be used to initiate or trigger deployment of the cannula.

In the example above, the system advantageously uses bi-directional actuation. The rotation of the motor is reversed to alternate intake and exhaust strokes. This provides a safety mechanism that prevents runaway should the motor malfunction. In order for the pump to continue to deliver drug from the reservoir, the motor must reciprocate in sequence. However, it should be understood that in other embodiments the metering system is designed to use a unidirectional actuator.

In the exemplary embodiment described above, the system uses a pouch reservoir with two flexible walls. However, in other embodiments, the reservoir can be formed in any suitable manner, including having one rigid wall and one flexible wall.

FIG. 13 is an exploded perspective view of a metering subsystem 1300 for a patch pump in accordance with another exemplary embodiment of the presently disclosed invention. Metering subsystem 1300 includes motor and gearbox assembly 1302 and pump assembly 1304 .

14 is an exploded perspective view of pump assembly 1304. FIG. Pump assembly 1304 includes piston 1306 mechanically coupled to sleeve 1308 via coupling pin 1310 within pump manifold 1312 . Pump assembly 1304 further includes port seal 1314 , plug 1316 , sleeve rotation limit switch 1318 and output gear rotation limit switch 1320 .

Piston 1306 can rotate a total of 196 degrees in either direction and translate by approximately 0.038 inches. Sleeve 1308 and plug 1316 rotate together (as a pair) 56 degrees in either direction. Pump manifold 1312 and port seal 1314 are stationary.

15 is an exploded perspective view of the motor and gearbox assembly 1302. FIG. Motor and gearbox assembly 1302 includes gearbox cover 1322 , compound gear 1324 , output gear 1326 , shaft 1328 , gearbox base 1330 , motor pinion gear 1332 , and DC motor 1334 .

16A-16D illustrate the assembly and operation of piston 1306, sleeve 1308 and coupling pin 1310. FIG. FIG. 16A illustrates a piston 1306 that includes a press fit hole 1338 that receives the coupling pin 1310 and a piston seal 1340 that seals the piston fluid-tight within the sleeve 1308 . Sleeve 1308 includes spiral groove 1342 . Piston 1306 is axially pressed into sleeve 1308 and coupling pin 1310 is then pressed through helical groove 1342 and into bore 1338 . This provision results in similar operation to the embodiments described above, with rotation of piston 1306 causing axial translation of piston 1306 relative to sleeve 1308 due to interaction of coupling pin 1310 and helical groove 1342 . FIG. 16B illustrates the assembled piston 1306 , sleeve 1308 and coupling pin 1310 , together with coupling pin 1310 shown at the lower end of helical groove 1342 . FIG. 16C illustrates axial stroke length 1344 of piston 1306 relative to sleeve 1308 as a result of helical groove 1342 . FIG. 16D illustrates tapered surface 1346 preferably provided at the end of helical groove 1342 to center coupling pin 1310 within groove 1342 .

17A illustrates the assembly of plug 1316 and sleeve 1308. FIG. As shown, plug 1316 includes key 1346 and seal 1348 . Seal 1348 provides an interference fit for the plug within sleeve 1308 . Sleeve 1308 is provided with a recess 1350 adapted to receive key 1346 . Key 1346 locks plug 1316 in rotational engagement with sleeve 1308 . The plug 1316 is pressed against the end face of the (advanced) piston 1306 during assembly to minimize air in the pump chamber. Friction between seal 1348 and the inner surface of sleeve 1308 retains plug 1316 axially. With proper selection of seal diameter, squeeze, and material, plug 1316 can also function as an occlusion or overpressure sensor. Pump pressure greater than the threshold causes plug 1616 to axially transition out of engagement with sleeve rotation limit switch 1318 . Friction holds the plug 1316 in place for pressures below the desired threshold. 17B and 17C illustrate the axial movement of piston 1306 within sleeve 1308. FIG. FIG. 17B illustrates piston 1306 in a first state with minimal or no pumping volume between piston 1306 and plug 1316 . As shown, coupling pin 1310 abuts against the lowermost end of helical groove 1342 . FIG. 17C illustrates piston 1306 in a second state with maximum pumping volume 1352 between piston 1306 and plug 1316 . As shown, coupling pin 1310 abuts against the top end of helical groove 1342 .

18A-18D illustrate the assembly of sleeve 1308 to manifold 1312. FIG. As shown in FIG. 18A, manifold 1312 includes port seals 1314 to seal reservoir port 1354 and cannula port 1356, respectively. A small side hole 1358 (see FIG. 17B) on the sleeve rotates between two ports that are 56 degrees apart. As shown in FIG. 18B, sleeve 1308 includes tabs 1360 and manifold 1312 includes corresponding slots 1362 to allow sleeve 1308 to be assembled to manifold 1312 . FIG. 18C illustrates manifold windows 1364 provided in the manifold. Tabs 1360 are received within windows 1364 and migrate when sleeve 1308 is assembled to manifold 1312 . Tab 1360 and window 1364 interact to allow sleeve 1308 to rotate between two positions while constraining axial translation of sleeve 1308 relative to manifold 1312 . Sleeve 1308 is rotated between a first position in which side hole 1358 is aligned with reservoir port 1354 and a second position in which side hole 1358 is aligned with cannula report 1356 . FIG. 18D illustrates sleeve 1308 assembled to manifold 1312 with tab 1360 positioned within manifold window 1364 .

FIG. 19 is a cross-sectional view of the assembled metering system. As shown, port seal 1314 is a face seal that is compressed between the OD (outer diameter) of sleeve 1308 and a recessed pocket in manifold 1312 . Also shown, tab 1360 is positioned within manifold window 1364 and side hole 1358 is shown transitioning between reservoir port 1354 and cannula report 1356 . Output gear 1326 includes a cam mechanism 1366 that engages rotation limit switch 1320 to signal the end of rotational movement of piston 1306 and sleeve 1308 in either direction.

20A-20E are cross-sectional views illustrating rotation of sleeve 1308 within manifold 1312 to transition the side port from alignment with reservoir port 1354 to alignment with cannula report 1356. FIG. FIG. 20A illustrates side holes 1358 aligned with reservoir ports 1354 . While in this position, piston 1306 transitions away from plug 1316 to fill volume 1352 with fluid from the reservoir. FIG. 20B illustrates sleeve 1308 as it begins to rotate toward cannula report 1356 . In this position, side hole 1358 is sealed by seal 1314 on reservoir port 1354 . For this reason, the diameters of seal 1314 and side hole 1358 are preferably selected such that seal 1314 covers the opening of side hole 1358 . FIG. 20C illustrates side hole 1358 of sleeve 1308 between seal 1314 of reservoir port 1354 and seal 1314 of cannula report 1356 . In this position, neither seal 1314 closes the side hole 1358, but the surface tension of the liquid keeps the liquid within the pump chamber. FIG. 20D illustrates side hole 1358 further rotated to a position where seal 1314 of cannula report 1356 covers the opening of side hole 1358 . Finally, FIG. 20E illustrates side hole 1358 rotated into alignment with cannula report 1356 . While in this position, piston 1306 translates axially to reduce volume 1352 and force fluid out of cannula report 1356 into the cannula.

Figures 21A-21C illustrate the operation of the limit switches. As shown in FIG. 21A, plug 1316 includes a cam mechanism 1368 that interacts with limit switch 1318. As shown in FIG. As sleeve 1308 and plug 1316 rotate, cam mechanism 1368 brings the metal flexures of limit switch 1318 into contact with each other until plug 1316 is fully rotated to the next position. When plug 1316 is at either end of plug rotation, ridge 1370 on one of the flexures rests in cam mechanism 1368, as illustrated in FIG. 21C. A limit switch 1318 that opens and closes on each rotation cycle signals that the plug 1316 remains in proper alignment with the limit switch 1318 . In an overpressure or blockage condition, the increased pressure causes plug 1316 to slide out of sleeve 1308 and out of alignment with limit switch 1318 . In this manner, an overpressure condition is detected. Limit switch 1320 is engaged by cam mechanism 1366 of output gear 1326 at each end of a rotation cycle. This signals the motor 1334 to rotate in reverse. As shown, using two metal flexures, it is not possible to determine from the limit switches which rotation cycle has been completed. However, as will be appreciated, the third bend allows the direction of engagement to be determined.

22A-22C illustrate the assembly of motor and gearbox 1302 and pump assembly 1304. FIG. As shown in FIGS. 22A and 22B, motor and gearbox 1302 includes opening 1372 for receiving rotation limit switch 1320 . In this way, the output gear 1326 inside the gearbox housing can access and engage the flexure of the limit switch 1320 . Motor and gearbox 1302 also includes axial retention snaps 1374 so that pump assembly 1304 can be snap-fitted to motor and gearbox 1302 . Motor and gearbox 1302 includes a rotation key 1376 in pump receiver socket 1378 for receiving pump assembly 1304 and for restraining rotation of pump assembly 1304 relative to motor and gearbox 1302 . Output gear 1326 includes slots 1380 (FIG. 22B) adapted to receive tabs 1382 (FIG. 22C) provided on piston 1306 . When assembled, tabs 1382 are received in slots 1380 such that output gear 1326 can transmit torque to piston 1306 . As the output gear 1326 rotates, the pump piston tabs 1382 rotate and slide axially within the slots. Motor connections and limit switch metal spring flexures are used to make electrical contact with pads on the circuit board during final assembly.

In operation, the pump cycle of the embodiment described above includes five steps. First, about 120 degrees of pump exhaust (counterclockwise when looking from the pump toward the gearbox), 56 degrees of valve state change (counterclockwise), 140 degrees of pump intake (clockwise), 56 degrees of A valve state change (clockwise), and a slight swing of about 20 degrees (counterclockwise) to clear the limit switch. A complete pump cycle requires 196 degrees of output gear rotation in each direction.

Figures 23A-30C illustrate the pump cycle. For clarity, only output gear 1326 of gearbox assembly 1302 is shown in the figure.

Figure 23A illustrates the starting position. As shown, the cam 1366 of the output gear 1326 is out of contact with the rotation limit switch 1320 such that the flexures are not in contact with each other. Pump piston 1306 is retracted as indicated by the position of coupling pin 1310 within helical groove 1342 in FIG. 22C. In this position, sleeve 1308 closes the reservoir flow path, cannula report 1356 is open to side hole 1358 of sleeve 1308, and rotation limit sensor 1320 and sleeve sensor 1318 (see FIG. 23B) are both open. It is

Figures 24A and 24B illustrate the metering subsystem during the ejection stroke. Output gear 1326 rotates pump piston 1306 in a first direction of rotation (see arrow in FIG. 24B), which travels through coupling pin 1310 (see FIG. 24A) into a helical path of helical groove 1342 in sleeve 1308. driven along. Pump piston 1306 rotates and translates away from the gearbox, expelling fluid out of pump chamber 1352 and cannula report 1356 . During the exhaust stroke, the friction between port seal 1314 and the outer diameter of sleeve 1308 should be high enough to ensure that sleeve 1308 does not rotate during this part of the cycle.

Figures 25A-25C illustrate the metering subsystem during a valve state change after the exhaust stroke. After coupling pin 1310 reaches the distal end of helical groove 1342, torque continues to be transmitted from output gear 1326 to pump piston 1306 and through coupling pin 1310 to sleeve 1308, as shown in FIG. 25A. Sleeve 1308 and pump piston 1306 rotate as a unit without relative axial motion. A side hole 1358 (not shown in FIGS. 25A-25C) on sleeve 1308 transitions between reservoir port 1354 and cannula report 1356 . Tab 1360 transitions in window 1364 of manifold 1312 in the direction indicated by the arrow. As shown in FIG. 25B, sleeve limit switch 1318 is closed by a camming surface on plug 1316 .

Figures 26A and 26B show the weighing subsystem in the eject spin stop position. Sleeve side hole 1358 (not shown in FIGS. 26A or 26B) is aligned with reservoir port 1354, pump volume 1352 is collapsed, and cannula report 1356 is closed. Plug 1316 is in the parked position and sleeve limit switch 1318 is open. Output gear cam 1366 contacts rotation limit switch 1320 to signal the end of rotation so that output gear 1326 stops reverse rotation.

Figures 27A and 27B show the metering subsystem during the intake stroke. Output gear 1326 rotates pump piston 1306 in the direction indicated by the arrow in FIG. 27B. Piston 1306 is translated axially relative to sleeve 1308 by interaction of coupling pin 1310 within helical groove 1364 . Pump piston 1306 translates toward the gearbox, drawing fluid from the reservoir into pump chamber 1352 . During the intake stroke, the friction between the seal and the outer diameter of sleeve 1308 should be high enough to ensure that sleeve 1308 does not rotate relative to manifold 1312 .

Figures 28A-28C show the metering subsystem during a valve state change after the intake stroke. Coupling pin 1310 reaches the upper end of helical groove 1342 and motor 1302 continues to provide torque, causing sleeve 1308 and piston 1306 to rotate together. Tabs 1360 on sleeve 1308 transition within windows 1364 of manifold 1312 in the direction indicated by the arrows in FIG. 28A. Cam surface 1368 on plug 1316 closes sleeve limit switch 1318 as plug 1316 rotates with sleeve 1308 . Sleeve 1308 and pump piston 1306 rotate as a unit without relative axial motion. During this rotation, side hole 1358 of sleeve 1308 transitions between reservoir port 1354 and cannula report 1356 .

Figures 29A and 29B show the metering subsystem in the intake rotation stop position. In this position, side hole 1358 of sleeve 1308 is aligned with cannula report 1356, pump volume 1352 is expanded, and reservoir port 1354 is closed. Cam 1366 of output gear 1326 engages rotation limit switch 1320 to signal that rotation is complete. Motor 1302 stops rotating in reverse. Sleeve limit switch 1318 is open.

Figures 30A-30C show the metering subsystem after the pump cycle is complete. The output gear cam 1366 has jolted away from the rotary switch 1320, ready to begin another cycle.

31A-31C illustrate another weighing system 3100a in accordance with an exemplary embodiment of the presently disclosed invention. FIG. 31A shows motor and gearbox assembly 3101 and modified pump assembly 3100 . Motor and gearbox assembly 3101 is substantially similar to the motor and gearbox assembly shown and described above in connection with FIGS. 13-30C.

32 is an exploded perspective view of pump assembly 3100. FIG. Pump assembly 3100 includes pump manifold 3102, port seals 3104, seal retainer 3106, rotating ±196 degrees and axially ±. It includes a piston 3108 that translates 038 inches, a coupling pin 3110 , a sleeve 3112 with conductive pads, and a sleeve rotation limit switch 3114 with a flex arm 3128 . Sleeve 3112 with conductive pads rotates ±56 degrees as shown.

Pump assembly 3100 includes three flexure arms 3128 that operate as rotary transfer limit switches 3114 . Rotational transition limit switch 3114 is described in further detail below. The rotational transition limit switch 3114 senses the position of the sleeve 3112 directly rather than sensing the position of the output gear. This allows for more precise angular alignment of the sleeve 3112 with respect to the manifold 3102 and cannula report.

33A-33B illustrate assembly of the piston 3108 to the sleeve 3112. FIG. In this embodiment, an inner wall 3113 within the sleeve 3112 forms the end face of the pump chamber. The features on the piston sleeve are designed to allow minimizing the clearance between the end face of the piston 3108 and the face of the inner wall 3113 of the sleeve.

34A-34E illustrate assembly of sleeve 3108 to manifold 3102. FIG. As shown, port seal 3104 , seal retainer 3106 and sleeve 3112 are inserted into manifold 3102 . A small side hole 3115 (see FIG. 34E) on the sleeve 3112 pivots between the reservoir port and the cannula report, preferably 56 degrees apart. The sleeve 3112 is inserted over the retaining tabs 3116 (see FIG. 34D) in the manifold 3102 and then rotated into place to resist axial translation. Since this embodiment inhibits or minimizes axial movement of the plug, occlusion detection by axial movement of the plug is generally not provided.

FIG. 35 illustrates a cross-section of the sleeve 3112 and manifold 3102 assembly taken through the port seal 3104 and through the axis of the side port to the manifold 3102. FIG. Side ports to manifold 3102 include cannula report 3118 and reservoir port 3120 . Port seal 3104 is a face seal and is compressed between the outer diameter of sleeve 3112 and a recessed pocket in manifold 3102 .

36A-36C are cross-sectional views through the axis of the side port as the sleeve 3112 rotates from the reservoir port 3120 to the cannula report 3118 to illustrate valve state changes. In the initial position shown in FIG. 36A, sleeve side hole 3115 is open to reservoir port 3120 . In this position, cannula report 3118 is closed. In the intermediate position shown in FIG. 36B, sleeve side hole 3115 is closed by port seal 3104 during transition. In the final position shown in FIG. 36C, sleeve side hole 3115 is open to cannula report 3118 . In this position, reservoir port 3120 is closed.

37A-37D illustrate the operation for the sleeve rotation limit switch 3114. FIG. The three-point contact switch design allows the patch system to distinguish between the two rotation limits via the switch input signal rather than tracking the angular orientation of the sleeve via software. Manifold 3102 preferably includes manifold mounting posts 3122 . Switch contact 3114 is bonded to post 3122 using adhesive, ultrasonic welding, thermal stakes, or any other suitable bonding method. Sleeve 3112 includes conductive pads 3124 at the ends of sleeve 3112 . These may be printed or overmolded metal inserts, or may be provided by any other suitable means. The sleeve rotation limit switch 3114 includes a plastic overmold 3126 for spacing and attachment mechanisms for the flexures. Sleeve rotation limit switch 3114 also includes three metal flexures 3128 . Manifold 3102 is provided with alignment slots 3130 that receive bends 3128 . In a first position shown in FIG. 37B, side hole 3115 on sleeve 3112 is aligned with cannula report 3118 . In this position, conductive pads 3124 on sleeve 3112 bridge the center and right contacts 3128a, 3128b. In the intermediate position shown in FIG. 37C, side hole 3115 on sleeve 3112 is midway between ports 3118 and 3120 . In this position, both sides of switch 3114 are open. In the final position shown in FIG. 37D, side hole 3115 on sleeve 3112 is aligned with reservoir port 3120 . In this position, conductive pads 3124 on sleeve 3112 bridge the center and left contacts 3128b, 3128c.

The pump described above has a modified operating sequence. The operating sequence is substantially the same as described above, except that the 20 degree rearward yaw is no longer required. A rearward jog is not necessary with the 3-point contact switch design described above, and a complete pump cycle consists of the following four segments. First, there is about 140 degrees of pump discharge, counter-clockwise when looking from the pump towards the gearbox. Then there is a 56 degree valve state change, also counterclockwise. Third, there is a 140 degree pump intake, which is clockwise. Fourth, there is a valve state change of 56 degrees clockwise. The sum of this pump cycle requires 196 degrees of output gear rotation in each direction.

Figures 38A and 38B illustrate an exploded view of another version of the pump assembly with elastomeric port and piston seals overmolded on the manifold and pump piston, respectively. This version of the pump functions in substantially the same manner as the one described above, but has fewer individual components and is easier to assemble. Overmolding the seal directly onto the manifold and piston reduces the dimensions that contribute to seal compression, allowing for less variability and tighter control of seal performance.

FIG. 39A illustrates an exploded view of pump assembly 3900 with an alternative rotation limit switch design. This version of the pump assembly includes a two point contact design for the sleeve rotation limit switch. With this design, the pump will properly jab back at the end of the pump cycle so that contact switch 3902 is left open. As shown in FIG. 39B, in a first position the side holes 3115 on the sleeve are aligned with the cannula report. In this position, a first rib 3904 on the sleeve forces the contract closed. In the intermediate position shown in FIG. 39C, the side hole 3115 on the sleeve is halfway between the ports and neither rib 3904, 3906 touches the contact switch 3902, so it is open. In the third position shown in FIG. 39D, the side hole 3115 on the sleeve is aligned with the reservoir port. In this position, a second rib 3906 on the sleeve again forces the contact switch 3902 closed.

40 is an exploded perspective view of another exemplary embodiment of weigh assembly 4000. FIG. Since this embodiment is substantially similar to the embodiment described above, the following discussion will focus on the differences. Metering assembly 4000 includes sleeve 4002 with spiral groove 4004 , plug 4006 , seal 4008 , plunger 4010 , coupling pin 4012 , manifold 4014 , port seal 4016 and flexible interlock 4018 . Figure 41 illustrates the weigh assembly in a packed configuration. Seal 4008 is preferably formed of an elastomeric material and is unitary in construction. One seal 4008 is attached to plug 4006 and the other seal 4008 is attached to plunger 4010 . Plug 4006 is preferably secured to sleeve 4002 by gluing, heat sealing, or any other suitable means. The end face of the plug forms one side of the pump volume. Plunger 4010 is inserted into sleeve 4002 and coupling pin 4012 is press fit into plunger 4010 and extends into helical groove 4004 to provide axial translation of plunger 4010 as it is rotated by a motor (not shown). The end face of plunger 4010 forms the facing face of the pump volume. Port seal 4016 is preferably a single piece of elastomeric material. In this embodiment, the number of parts is reduced and manufacturability is improved. FIG. 42 is a cross-sectional view of the assembled weighing assembly;

43A-43C illustrate the interaction of interlock 4018 and sleeve 4002. FIG. As shown in FIG. 41, interlock 4018 is attached to manifold 4014 at either end of interlock 4018 . As shown in FIG. 43A, the end face of sleeve 4002 includes a detent 4020 that abuts ridge 4022 of interlock 4018 when the metering assembly is in the first position (side hole aligned with reservoir pump). I'm in. Under certain conditions, such as back pressure, the friction between piston 4010 and sleeve 4008 is sufficient to rotate the sleeve before plunger 4010 and coupling pin 4012 reach either end of helical groove 4004. can be. This could result in an incomplete volume of liquid delivered per stroke. To restrain this situation, interlock 4018 restrains sleeve 4002 from rotating until torque passes a predetermined threshold. This ensures that the piston 4010 rotates completely within the sleeve 4008 until the coupling pin 4012 reaches the end of the helical groove 4004 . When the coupling pin hits the end of the helical groove 4004, further motion by the motor increases the torque on the sleeve beyond the threshold, deflecting the interlock and allowing the detent 4020 to pass by the ridge 4022. do. This is illustrated in FIG. 43B. Upon completion of rotation of sleeve 4008 such that the side hole is oriented with the cannula report, detent 4020 transitions over ridge 4022 in interlock 4018 . This is illustrated in FIG. 43C.

FIG. 44 illustrates a cross section of another exemplary embodiment of weighing system 4400 . Metering system 4400 includes a modified sleeve 4402 having a surface 4404 forming one side of the pump volume. This embodiment eliminates the need for a plug as in the previous embodiment and simplifies manufacturing.

FIG. 45 illustrates another exemplary embodiment having a modified sleeve 4500 and switching mechanism 4502. FIG. FIG. 46 is a perspective view of a modified sleeve 4500 that includes detents 4504 similar to the sleeves described above for interacting with an interlock (not shown). Switch mechanism 4502 includes a limit switch arm 4506 adapted to rotate in either direction away from its neutral position. Sleeve 4500 includes a switching lever (actuator arm) 4508 adapted to interact with limit switch 4506 as sleeve 4500 rotates. FIG. 47 illustrates limit switch 4506 rotating about an axis. Switch mechanism 4502 provides an electrical signal to indicate the position of limit switch 4506 . FIG. 48 is a top view illustrating sleeve 4500 rotated to an orientation in which limit switch 4506 is rotated from a neutral position to its maximum angle (α). Further rotation of the sleeve causes limit switch 4506 to break free from actuator arm 4508 and return to its neutral position. This change in switch arm orientation indicates the end of rotation of the sleeve 4500 in one direction, causing the rotary metering pump to reverse rotation. FIG. 49 is a side view facing the sleeve face, illustrating the same interaction between limit switch 4506 and actuator arm 4508. FIG. FIG. 50 is a side view showing the sleeve 4500 and switching mechanism 4502 incorporated into the patch pump with an interlocking collar 4510. FIG.

51A illustrates the relative angular positions of limit switch 4506 and actuator arm 4508. FIG. α is the angle of the limit switch 4506 . β is the angle of the rotating sleeve and actuating arm. FIG. 51B illustrates the relative change d(α)/d(β) versus β. Reverse rotation is preferably activated at β=33 degrees. As shown, rotation of the actuating arm 4608 pushes the limit switch 4506 away from the neutral position (α=0 degrees). When the actuating arm angle β reaches approximately 30β, the actuating arm 4508 clears the limit switch 4506 and the limit switch 4506 returns to neutral (α=0 degrees), thereby causing reverse rotation of the rotary pump. be started. The same procedure occurs in reverse when the sleeve 4508 rotates in the other direction. Accordingly, the sleeve reciprocates back and forth.

An improved plunger and pump plug component will now be described in connection with FIGS. 52-67. As will now be described, the improved plunger 5210 and pump bottom 5206 make the pump more flexible by making these components easier to manufacture and assemble and by eliminating potential sources of fluid leakage from previous designs. Improve. Plunger 5210 is illustrated in multiple views in FIGS. 52-58. Plunger 5210 is substantially similar to plunger 4010 illustrated in FIG. 40, except O-ring 4008 is not required because a seal, described below, is overmolded onto head 5212 of plunger 5210 .

The seal 5214 is illustrated in multiple views in FIGS. 59-62. Seal 5214 is advantageously overmolded onto head 5212 of plunger 5210 . Therefore, the plunger with seal is advantageously manufactured in a two-shot molding process. Plunger 5210 is molded from a hard plastic material, and then seal 5214 is molded from viscoelastic elastomer onto plunger 5210 as a second shot. The plunger 5210 and seal 5214 combination is easier to assemble into the overall pump and can reduce the chance of leakage provided by the o-ring design.

A pump stopper or plug 5206 is illustrated in FIGS. 63-67. Stopper 5206 is constructed such that seal 5214 (the same or substantially similar seal components may be used for both plunger 5210 and stopper 5206) is overmolded onto head 5208 of stopper 5206 in place of an O-ring. substantially corresponds to plug 4006 of FIG. Similar to plunger 5210 described above, stopper 5206 and seal 5214 are preferably manufactured in a two-shot molding process. Stopper 5206 is molded from a hard plastic material and seal 5214 is molded over stopper 5206 as a second shot from a viscoelastic elastomer.

FIG. 68 illustrates an exploded view of metering assembly 4000, but with modified plunger 5210, stopper 5206 and seal 5214. FIG. It will be appreciated by those skilled in the art that just as plug 4006 was optional in previous designs and could be replaced with wall 4404 as shown in FIG. 44, stopper 5206 is also optional and could be replaced with a similar wall. be understood.

A method 6900 of manufacturing and assembling a pump in accordance with an exemplary embodiment of the invention utilizing the overmolded parts described above will now be described with reference to FIG. First, at step 6902, a plunger is molded from hard plastic. Next, at step 6904, a seal is overmolded over the head of the plunger. The seal is molded from a viscoelastic elastomer and dimensioned to seal well within the pump chamber. Optionally, at step 6906 the pump stopper is molded from hard plastic and at step 6908 a seal is overmolded to the head of the pump stopper. The plunger and pump stopper are inserted into the pump chamber of the pump at step 6910 . A pin is inserted into the plunger hole to allow axial translation of the plunger as the pump motor rotates the pump chamber (step 6912).

Although only a few exemplary embodiments of the presently disclosed invention have been described above in detail, it will be appreciated by those skilled in the art that the exemplary embodiments may be modified without departing substantially from the novel teachings and advantages of this invention. It will be readily understood that many modifications are possible in and that various combinations of the exemplary embodiments are possible. Accordingly, all such modifications are intended to be included within the scope of this invention.

Claims (13)

a manifold having a reservoir port in fluid communication with the fluid reservoir and a cannula report in fluid communication with the cannula;
a sleeve having a side hole in the manifold in a first orientation with the side hole aligned with the reservoir port and in a second orientation with the side hole aligned with the cannula report; a sleeve adapted for axial rotation between and further having a helical groove having a first end and a second end;
A plunger having an overmolded seal molded over the plunger head and adapted for rotation and axial translation within said sleeve, said plunger axial translation within said sleeve. changes a pump volume, said pump volume being in fluid communication with said side bore of said sleeve, said plunger being positioned within said spiral groove at first and second ends of said spiral groove; a plunger further comprising a coupling member adapted to transition between and axially translate the plunger within the sleeve when the plunger is rotated;
adapted to rotate the plunger in the first orientation to increase pumping volume when the sleeve is in the first orientation, the coupling member being positioned at the first end of the helical groove; a motor that, when reached, rotates the sleeve and the plunger together so that the sleeve transitions to the second orientation;
a rotation limit switch for reversing the motor after the sleeve has been rotated to orient the side hole with the cannula report;
The sleeve has an actuator arm fixed to the sleeve, the actuator arm moving a limit switch as the sleeve rotates in either direction, the limit switch moving the actuator arm to the limit switch. deflected to return to a central position when passed,
A rotary metering pump characterized by: The plunger further has a tab, the manifold has a window, the tab transitions within the window, and the sleeve axially translates relative to the manifold as it rotates within the manifold. 2. The rotary metering pump of claim 1, restrained from doing. 2. A plug having a seal overmolded on the head of the plug, the plug being inserted within the sleeve and forming a surface of the pump volume facing the plunger. A rotary metering pump as described in . 2. The rotary metering pump of claim 1, wherein said sleeve has a chamfer forming a surface of said pump volume facing said plunger. 2. The rotary metering pump of claim 1, further comprising seals on said plunger and said plug for forming fluid tight seals between said plunger and said plug and between said plug and said sleeve. The motor has an output gear having a slot for receiving the tab of the plunger, the slot permitting axial transition of the plunger relative to the motor while the motor rotates the plunger. 2. The rotary metering pump of claim 1, allowing an interlock inhibiting rotation of the sleeve when the torque applied to the sleeve is below a predetermined threshold, the interlock inhibiting rotation of the sleeve when the torque exceeds the predetermined threshold 2. A rotary metering pump according to claim 1, wherein the sleeve is allowed to rotate. The sleeve has a detent that engages a ridge on the interlock to restrain rotation of the sleeve, the interlock being activated when torque applied to the sleeve exceeds a predetermined limit. 8. The rotary metering pump of claim 7, wherein said detent deflects to permit transition past said ridge on said interlock. 2. The rotary metering pump of claim 1, further comprising at least one port seal forming a fluid tight seal between said sleeve and said reservoir port. 2. The rotary metering pump of claim 1, further comprising at least one port seal forming a fluid tight seal between said sleeve and said cannula report. 2. A rotary metering pump according to claim 1, wherein the port seal is a one-piece elastomeric component. molding the plunger from a hard material;
overmolding a seal comprising a viscoelastic elastomer onto the head of the plunger;
inserting the plunger and the seal into a pump chamber; and
inserting a pin through a slot in a sleeve containing the pump chamber and into a hole in the plunger;
A method of manufacturing a rotary metering pump, comprising: molding the pump stopper from a rigid material;
overmolding a seal comprising a viscoelastic elastomer onto the head of the pump stopper; and
inserting the pump stopper into the pump chamber;
13. The method of manufacturing a rotary metering pump of claim 12, further comprising:

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