INFUSION PUMPS AND METHODS WITH SHAPE MEMORY WIRE DRIVEN SYRINGE MECHANISM

TECHNICAL FIELD

The present disclosure relates generally to ambulatory infusion pumps and, more particularly, to a user-wearable pump, such as a patch pump, for delivering medicament such as insulin to a patient.

BACKGROUND

There are a wide variety of medical treatments that include the administration of a therapeutic fluid in precise, known amounts at predetermined intervals. Devices and methods exist that are directed to the delivery of such fluids, which may be liquids or gases, are known in the art.

One category of such fluid delivery devices includes insulin injecting pumps developed for administering insulin to patients afflicted with type I, or in some cases, type II diabetes. Some insulin injecting pumps are configured as portable or ambulatory infusion devices can provide continuous subcutaneous insulin injection and/or infusion therapy as an alternative to multiple daily injections of insulin via a syringe or an injector pen. Such ambulatory infusion pumps are worn by the user and may use replaceable cartridges. In some embodiments, these pumps may also deliver medicaments other than, or in addition to, insulin, such as glucagon, pramlintide, and the like. Examples of such pumps and various features associated therewith include those disclosed in U.S. Patent Publication Nos. 2013/0324928 and 2013/0053816 and U.S. Pat. Nos. 8,287,495; 8,573,027; 8,986,253; and 9,381,297, each of which is incorporated herein by reference in its entirety.

One type of pump that has been developed is a patch pump, or micro pump. Patch pumps generally are small pumps, typically ambulatory, that are carried directly on the skin under the user's clothing. Many such pumps are situated directly on the infusion site such that no tubing is required to deliver the insulin and/or other medicament to the patient. Other patch pumps can be positioned on the patient's body with a short length of tubing extending to a nearby infusion site. Some patch pumps can be at least in part disposable, meant to be worn for a period of time such as, e.g., a day or two, and then discarded and replaced by a new patch pump. Other patch pump designs contemplate a disposable component, such as a cartridge that contains medicament, and a reusable or durable component. In such configurations, the disposable and durable components may be joined together by the patient or caregiver in preparation for delivery of the medicament.

Ambulatory infusion pumps such as patch pumps can employ various actuation mechanisms for driving the system to deliver medicament to the user, including electromagnetic drive motors, piezoelectric motors, and electrically driven shape-memory alloy (SMA) wire actuators. SMA wire has been used in a variety of miniaturized mechanism designs, including patch pumps, and has cost and size advantages over other actuation mechanism. SMA wire actuators operate on the principle of material phase transformation due to electrical heating. This phase transformation generates an approximately 4% strain in the form of shrinkage that can be used to operate on a mechanism and extract usable work. One disadvantage of SMA technology is relatively low work and power output that makes it not suitable for applications that require high power or high work output. However, a disposable medical pump with low delivery rates is an example of a type of application for which SMA wire mechanisms would be suitable.

SUMMARY

Disclosed herein are apparatuses and methods for an ambulatory infusion pump actuated with a shape memory alloy (SMA) wire. An SMA wire operated mechanism can include an actuator lever to increase the SMA wire's strain into a usable displacement to pull on a pawl that ratchets to a ratchet wheel to rotate a lead screw to advance a plunger a precise amount within a reservoir to deliver a precise amount of fluid.

In an embodiment, an ambulatory infusion pump can include a reservoir configured to contain a medicament, a syringe assembly including a plunger configured to dispense medicament from the reservoir, a ratchet wheel configured to rotate the syringe assembly, a pawl configured to engage with the ratchet wheel and an actuator lever mechanically linked to the pawl. A shape memory wire can be mechanically linked with the actuator lever such that actuation of the shape memory wire shortens the shape memory wire to cause the shape memory wire to move the actuator lever such that the actuator lever moves the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir.

In an embodiment, an ambulatory infusion pump can include a reservoir configured to contain a medicament and a syringe assembly including a plunger configured to dispense medicament from the reservoir. A ratchet wheel configured to rotate the syringe assembly can be disposed on the syringe assembly and a pawl can be engaged with the ratchet wheel. An actuator lever can be mechanically linked to the pawl and a shape memory wire can be mechanically linked to the actuator lever. Actuation of the shape memory wire can shorten the shape memory wire to cause the shape memory wire to move the actuator lever such that the actuator lever moves the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir.

In an embodiment, an ambulatory infusion pump can include a reservoir configured to contain a medicament, a syringe assembly including a plunger configured to dispense medicament from the reservoir and a ratchet wheel and pawl mechanism mechanically linked to the syringe assembly. A shape memory wire can be mechanically linked with the ratchet and pawl mechanism such that actuation of the shape memory wire shortens the shape memory wire to cause the shape memory wire to move the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir.

The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

FIGS. 1A-1C depict various views of an infusion pump according to an embodiment of the disclosure.

FIG. 2 depicts the infusion pump of FIGS. 1A-1C upon actuation.

FIGS. 3A-3C depict cross-sectional views of the infusion pump of FIGS. 1A-1C.

FIGS. 4A-4D depict various views of an infusion pump according to an embodiment of the disclosure.

FIG. 5 depicts an infusion pump according to an embodiment of the disclosure.

FIGS. 6A-6B depict one or more remote control devices that can be used to communicate with infusion pumps according to the disclosure.

FIGS. 7A-7C depict an infusion pump according to an embodiment of the disclosure.

FIGS. 8A-8C depict an infusion pump according to an embodiment of the disclosure.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

DETAILED DESCRIPTION

The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.

FIGS. 1A-1C depict a user-wearable infusion pump 100 that may be configured as a disposable patch pump according to the disclosure. Infusion pump 100 can include a housing (not pictured) surrounding the depicted components. A reservoir 102 can be configured to contain a medicament. In embodiments, infusion pump 100 can be a single use ambulatory pump intended to be worn directly on a user's body and disposed of after using the medicament in the reservoir 102. In some embodiments, the reservoir 102 can have a small volume, i.e., 1 mL or less, and be intended for use with concentrated insulin and/or for pediatric applications that have small delivery volumes. Such an infusion pump 100 can also include an adhesive patch (not pictured) that enables the user to wear the pump directly on the user's body. Infusion pump 100 can be powered by one or more coin cell batteries 104 disposed within housing. The components of the system can be mounted on a printed circuit board assembly (PCBA) 106 electrically connecting the battery with the other electronic components of the system. Pumps such as those disclosed herein can be actuated to give a consistent volume of fluid per electrical pulse at regular intervals such as every five minutes such that one or more pulses is required to deliver the desired volume of medicament each interval.

A shape memory alloy (SMA) wire 108, such as Nitinol, can extend from electrical connectors 110 and be routed around a pin 112. In embodiments, SMA wire 108 can be configured as a single continuous wire. Pin 112 can be mounted on assembly 108 in a manner that allows limited lateral movement of pin 112 and pin 112 can extend through an aperture in an actuator lever 114 with the pin 112 having a head that is larger than the aperture to prevent the actuator lever 114 from disengaging from pin 112. Actuator lever 114 can further include a first projection 116 for holding a spring 120 and a second projection 118 that extends through an aperture in a pawl 122. First projection 116 can be mounted on a rotation pin 124 that is rotatably fixed on the board 106 to enable the actuator lever 114 to be rotated about pin 124. Pawl 122 includes an elongate aperture 126 sized to fit around a portion of a ratchet wheel 128 and a distal surface 130 on which an individual tooth of the ratchet wheel can rest. As will be described in more detail below, rotation of ratchet wheel 128 drives a lead screw 132 to move a plunger 134 to deliver medicament contained in the reservoir 102 out an outlet 136.

Referring now to FIGS. 1B and 2, when SMA wire 108 is heated using energy from the batteries 104, the wire transitions from a first length to a second, shorter length. The shortening of the length of SMA wire 108 causes the wire to pull on the wire pin 112 it is wrapped around to move the pin 112 laterally towards the connectors 110 to which the SMA wire 108 is fixed (compare the position of pin 112 in FIG. 1B to the position in FIG. 2). The pin 112 therefore pulls on the actuator lever 114 to pivot the actuator lever about the rotation pin 124 through the first projection 116 of actuator lever. The second projection 118 of the actuator arm then also pulls on the pawl 122 causing the pawl 122 to pull on the ratchet wheel 128. As most clearly depicted in FIG. 1B, it can be seen that a distance between the rotation pin 124 about which the actuator lever 114 rotates and the connecting projection 118 attaching the actuator lever 114 to the pawl 122 is greater than a distance between the pivot pin 114 and the wire pin 112 around which the SMA wire wraps. This asymmetry enables the relatively small SMA-wire strain (i.e., change in length) to effectively be “multiplied” into a greater travel distance of the pawl 122 by the ratio of the distances between the two attachment pins 112, 118 and the pivot pin 114.

In embodiments, spring 120 is a torsion spring having an arm 121 that wraps around second projection 118 connecting the actuator lever 114 to the pawl 122. As such, following actuation of the SMA wire, when the wire returns to its original, longer length the biasing force of the arm 121 of the torsion spring 120 on the second projection 118 rotates the actuator lever 114 back about mounting pin 124 to return the pin 112 and second projection 118 to their original positions depicted in FIG. 1B. The dimensions, positioning, etc. of each of the components of the system can be configured such that with each such actuation the ratchet wheel 128 is rotated by a single tooth such that the next tooth on the wheel then rests on the distal end 130 of the pawl when the pawl 122 is moved back to its original position by the actuator lever 114. In addition, each single tooth rotation of the ratchet wheel 128 corresponds to a precise predefined amount of medicament that will be delivered from the reservoir 102. It has been found that, in some embodiments, by having the pawl 122 pull, rather than push, on the ratchet wheel 128 that the disclosed system is simpler, more robust, and less error prone that systems in which the pawl pushes a ratchet wheel.

The manner in which rotation of the ratchet wheel 128 effects delivery of medicament with pump 100 can be described in greater detail with reference to FIGS. 3A-3C. Ratchet wheel 128 can be attached to or unitarily formed with a hollow tube 138 containing a drive tube 140 having a threaded interior that interfaces with the lead screw 132 attached to the plunger 134. Referring to FIG. 3A, the pump 100 is depicted in an empty, pre-filled configuration (i.e., because plunger 134 is at the distal end of reservoir 102 there can be no medicament in reservoir 102). When the pump is filled, as depicted in FIG. 3B, the drive tube 140 and lead screw 132 are fully nested inside of the hollow tube 138 with the plunger 134 at the far proximal end of the reservoir. As the device is incrementally operated to dispense medicament as described above, the lead screw 132 and plunger 134 are advanced distally through the reservoir 102 relative to the hollow tube 138 and drive tube 140 to force medicament out of the outlet 136 due to the threaded interior surface of the drive tube 140 driving the threaded lead screw 132 when the drive tube is rotated 140 by the interaction of the ratchet wheel 128 and pawl 122.

FIGS. 4A-4D depict the interior of a user-wearable infusion pump 200 according to another embodiment of the disclosure. Pump 200 operates using similar principles as pump 100 with a slightly different configuration. In this embodiment, the SMA wire 208 extends from connectors 210 and travels underneath pawl 222 to wrap around pin 212 attached to actuator lever 214. The actuator lever 214 is similarly configured to pivot about a pin 224 when pulled on by the SMA wire 208 to pull on the pawl 222 to which it is connected with a pin 218, projection, or other element. As with the previous embodiment, the pawl 222 then pulls on the ratchet wheel 228 to rotate the wheel to drive the lead screw 232 and plunger 234 to expel a precise amount medicament from the reservoir 202 corresponding to rotation of the ratchet wheel 228 by a single tooth. The actuator lever 214 can similarly be spring loaded such that when the SMA wire 208 is no longer electrically heated, and therefore cools off and elongates back to its original length, the actuator lever rotates back to its initial position depicted in FIG. 4A and the pawl resets onto the next tooth of the ratchet wheel 228. Referring to the partial view of FIG. 4C, it can be seen that a distance between the pivot pin 224 about which the actuator lever 214 rotates and the pin 218 attaching the actuator lever 214 to the pawl 222 is greater than a distance between the pivot pin 214 and the pin 212 around which the SMA wire wraps. This asymmetry enables the relatively small SMA-wire strain (i.e., change in length) to effectively be “multiplied” into a greater travel distance of the pawl 222 by the ratio of the distances between the two attachment pins 212, 218 and the pivot pin 214.

Referring now to FIG. 4D, the position of pawl 222 in both the “start” position 222A prior to actuation of the SMA wire and “finish” position 222B when the SMA wire has been actuated to move the pawl is depicted. As can be seen from these two positions, as the pawl 222 is pulled to actuate on the ratchet wheel 228 in response to the SMA wire being energized, the actuation radius of the pawl 222 to the center of the ratchet wheel 228 (i.e., a distance between the pawl and the center of the ratchet wheel) slightly increases such that progressively less force is required to rotate the wheel as the pawl moves. This reduces the effort felt by the SMA wire and helps increase the wire's longevity when actuating over many cycles because SMA alloys have a preference for having maximum stress at the beginning of the actuation and not at the end.

FIG. 5 depicts the interior of a user-wearable infusion pump 300 according to another embodiment of the disclosure. Pump 300 operates using similar principles as pump 100, 200, but this embodiment includes two pawls 322, 323. In embodiments, the second pawl 323 can be offset from the first pawl 322 by a distance equivalent to half of a tooth of the ratchet wheel 328. Each pawl 322, 323 alternatively engages the ratchet wheel on each actuation of the SMA wire such that each actuation causes a half-tooth rotation of the ratchet wheel rather than a full tooth as in the previous embodiments. The result of this approach is to provide double the resolution (i.e., half the dose for each actuation) without modifying the size or pitch of the teeth on the ratchet wheel (which are already required to be manufactured very small). As such, a minimum dispense size of pump 300 is half that of pumps 100 and 200, assuming an otherwise equivalently sized system.

FIGS. 7A-7C depict an infusion pump 400 according to another embodiment of the disclosure. Pump 400 includes a number of similar components to those of pumps 100, 200, 300 including a reservoir 402, batteries (not depicted), PCBA (not depicted), SMA wire 408, electrical connector/pin 410, pin 412, actuator lever 414, spring 420, pawl 422, mounting pin 418, rotation pin 424 pawl aperture 426, ratchet wheel 428, distal surface 430 of pawl 422, lead screw 432, plunger 434 and outlet 436. Not depicted in the previous embodiments, though necessarily present, is a pump housing 401 surrounding the internal components.

In this embodiment, the SMA wire 408 is configured as a spring. The bias spring 420 extends from the same mounting pin 424 that connects the pawl 422 and the actuator lever 414 to another mounting pin 440 such that the bias spring 420 is aligned across from the SMA wire 408 along the actuator lever 414. As the actuator lever 414 pivots about the rotation pin 424, a pair of stop pins 442 are positioned on opposing sides of the actuator lever 414 adjacent the end to which the SMA wire 408 is attached to limit a path of travel of the actuator lever 414. This corresponds to how limiting how far the pawl 422 (“hot” state) and ratchet wheel 428 (“cold”) state can travel, as will be apparent from the below.

FIG. 7B depicts the device 400 in the “cold” state in which the SMA wire 408 is not energized and therefore in an extended state. In this configuration, there is minimal force on the actuator lever 414. FIG. 7C depicts the device 400 in the “hot” state in which the SMA wire 408 is energized, which causes the SMA wire 408 to shorten and to therefore pull the pin 412 towards the electrical connector pin 410 to cause the actuator lever 414 to pivot about rotation pin 424. SMA wire 408 shortens with enough force to cause bias spring 420 to expand and move the side of the actuator lever 414 with the mounting pin 418 away from mounting pin 440. As pawl 422 is also attached to mounting pin 418, this movement therefore also pushes the pawl forwards along the ratchet wheel 428. Although not depicted herein, ratchet wheel will include teeth 428 similar to those depicted in the previous embodiments, and each actuation of the SMA wire 408 can cause the pawl 422 to advance the ratchet wheel 428 by a single tooth (or other predetermined number of teeth) to dispense a predetermined amount of medicament from the reservoir 402 as explained in more detail above. After the SMA wire 408 has been energized, it will gradually return to the “cold” state depicted in FIG. 7B. In this embodiment, rotation of the lead screw 432 to dispense medicament occurs as the SMA wire gradually returns from the “hot” state in FIG. 7C to the “cold” state of FIG. 7B. However, this approach can in other embodiments be reversed by exchanging the positions of the SMA wire spring 408 and the bias spring 420 such that the SMA wire spring is attached to the mounting pint 418 with the pawl 422 and the bias spring is on the opposite side of the lever actuator.

FIGS. 8A-8C depict an infusion pump 500 according to an embodiment of the disclosure. Pump 500 includes a number of similar components to those of pumps 100, 200, 300, 400 including a reservoir 502, batteries (not depicted), PCBA (not depicted), SMA wire 508, electrical connector/pin 510, pin 512, actuator lever 514, pawl 522, mounting pin 518, rotation pin 524, pawl aperture 526, ratchet wheel 528, distal surface 530 of pawl 522, lead screw 532, plunger 534, outlet 536 and stop pins 542. A pump housing 501, cut away for better depiction of the internal components, would surround the components.

In contrast to the previous embodiment, there is no bias spring 420 connected to the pawl 522 and actuator lever 514 in addition to the SMA wire spring 508. In addition, the positioning of the electrical connector pin 510 and the movable pin 512 connected to the actuator lever 514 is flipped, with the electrical connector pin 510 being located closer to the ratchet wheel 528. In this embodiment, the actuator lever 514 angles to extend from the pin 512 to the mounting pin 518 for the pawl 522. A mechanical advantage of this configuration of 1:2 is applied to the actuator lever 514, which reduces the force required to actuate the lever 514 and, consequently, the ratchet wheel 528. As with the previous embodiment, as the actuator lever 514 pivots about the rotation pin 524, a pair of stop pins 542 are positioned on opposing sides of the actuator lever 514 to limit a path of travel of the actuator lever 514. This corresponds to limiting how far the pawl 522 and ratchet wheel 528 can travel, as will be apparent from the below.

Referring to FIG. 8B, pump 500 is depicted in the “cold” state in which the SMA wire spring 508 is not energized. In this configuration, the SMA wire spring 508 is elongated and the actuator lever 514 rests against stop pin 542A. FIG. 8C depicts the pump 500 in the “hot” state in which the SMA wire spring 508 is energized. This causes the spring 508 to shorten as shown in FIG. 8C, which pulls the actuator lever 514 at the pin 5112 to move the lever 514 about the rotation pin 524 until the lever 514 contacts the other stop pin 542B.

The transition between hot (FIG. 8C) and cold (FIG. 8B) states will trigger the pawl 522 movement of the ratchet wheel 528 and the corresponding advancement of the lead screw 532 and plunger 435 to dispense medicament from the reservoir 502 out of the outlet 536. In this embodiment, the lead screw 532 rotation takes place during the hot state in FIG. 8C. In particular, as the SMA wire spring 508 shortens as shown in FIG. 8C to pull the pin 512 and actuator lever 514, the lever 514 rotates about the rotation pin 524 to pull in the opposite direction on the mounting pin 518. This pulls on the pawl 522 in the direction indicated by the arrow, which in turn causes the distal end of the pawl 530 to pull on the ratchet wheel 528. As with previous embodiments, rotation of the ratchet wheel 528 causes a corresponding advancement of the lead screw 532 and plunger 534 to dispense a predetermined amount of medicament out of the outlet 536. As the state gradually changes from hot back to cold, the pawl 522 advances along the ratchet wheel 528 as indicated in FIG. 8B to rest along the next tooth on the ratchet wheel and prepare for another ratchet wheel rotation when the spring 508 is next energized.

Referring to FIGS. 6A-6B, one or more remote control devices 170, 171 can be used to communicate with the processor of pump 100 to control delivery of medicament and transfer data with pump 100 via a wired or a wireless electromagnetic signal, such as via, e.g., a near field communication (NFC) radio frequency (RF) modality or other RF modalities such as Bluetooth®, Bluetooth® low energy, mobile or Wi-Fi communication protocols, for example, according to embodiments of the present disclosure. Such a remote control can include, for example, a mobile communication device, such as a smart phone (not depicted) executing a software application for control of the pump, a dedicated remote controller 171 (as depicted in FIGS. 4A-4B), a wearable electronic watch or electronic health or fitness monitor or personal digital assistant (PDA), etc., or a tablet, laptop or personal computer. Such communications between (and among) the one or more remote control devices and pump 100 may be one-way or two-way for, e.g., effective transfer of data among the devices and the pump, control of pump operations, updating software on the devices and/or pump, and allowing pump-related data to be viewed on the devices and/or pump.

In embodiments, an ambulatory infusion pump can include a reservoir configured to contain a medicament, a syringe assembly including a plunger configured to dispense medicament from the reservoir, a ratchet wheel configured to rotate the syringe assembly, a pawl configured to engage with the ratchet wheel and an actuator lever mechanically linked to the pawl. A shape memory wire can be mechanically linked with the actuator lever such that actuation of the shape memory wire shortens the shape memory wire to cause the shape memory wire to move the actuator lever such that the actuator lever moves the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir.

In embodiments, the pump further includes means for limiting an amount that the actuator lever can move.

In embodiments, the means for limiting the amount that the actuator lever can move comprises a pair of pins.

In embodiments, the amount that the actuator lever can move corresponds to how much the ratchet wheel is rotated.

In embodiments, the pair of pins are located on opposing sides of an end of the actuator lever.

In embodiments, the pump further includes a pin about which the actuator lever rotates.

In embodiments, the pump further includes a mounting pin connecting the actuator level to the pawl.

In embodiments, the actuator lever moves the pawl by pulling on the pawl away from the ratchet wheel with the mounting pin.

In embodiments, the ratchet wheel includes a plurality of teeth and the shape memory wire returns to an elongated state following actuation, and the pawl advances a single tooth along the ratchet wheel when the shape memory wire returns to the elongated state

In embodiments, the shape memory wire is configured as a spring.

In embodiments, an ambulatory infusion pump can include a reservoir configured to contain a medicament, a syringe assembly including a plunger configured to dispense medicament from the reservoir and a ratchet wheel and pawl mechanism mechanically linked to the syringe assembly. A shape memory wire can be mechanically linked with the ratchet and pawl mechanism, such that actuation of the shape memory wire shortens the shape memory wire to cause the shape memory wire to move the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir.

In embodiments the pump further includes means for limiting an amount that the pawl can move.

In embodiments, the means for limiting the amount that the pawl can move comprises a pair of pins.

In embodiments, the pair of pins are located on opposing sides of an end of an actuator lever mechanically linked to the pawl.

In embodiments, the pump further includes an actuator lever mechanically linked to the pawl

In embodiments, the pump further includes a pin about which the actuator lever rotates.

In embodiments, the pump further includes a mounting pin connecting the actuator level to the pawl.

In embodiments, the actuator lever moves the pawl by pulling on the pawl away from the ratchet wheel with the mounting pin.

In embodiments, the shape memory wire is configured as a spring.

In embodiments, an ambulatory infusion pump can include a reservoir configured to contain a medicament and a syringe assembly including a plunger configured to dispense medicament from the reservoir. A ratchet wheel configured to rotate the syringe assembly can be disposed on the syringe assembly and a pawl can be engaged with the ratchet wheel. An actuator lever can be mechanically linked to the pawl and a shape memory wire can be mechanically linked to the actuator lever. Actuation of the shape memory wire can shorten the shape memory wire to cause the shape memory wire to move the actuator lever such that the actuator lever moves the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir.

In some embodiments, the actuator lever pulls on the pawl to rotate the ratchet wheel and syringe assembly when the shape memory wire is actuated.

In some embodiments, the actuator lever pushes on the pawl to rotate the ratchet wheel and syringe assembly when the shape memory wire is actuated.

In some embodiments, the ratchet wheel comprises a plurality of teeth and a distance between each tooth corresponds to the predetermined amount of medicament.

In some embodiments, each actuation of the shape memory wire causes the pawl to move a single tooth along the ratchet wheel.

In some embodiments, the pawl includes an elongate aperture configured to fit around a portion of the plurality of teeth of the ratchet wheel.

In some embodiments, a spring is mechanically linked to the actuator lever and wherein the spring is configured to aid in returning the actuator lever to an original position following actuation of the shape memory wire.

In some embodiments, the syringe assembly comprises a drive tube having internal threads interfaced with a lead screw attached to the plunger and the ratchet wheel is disposed around the drive tube such that rotation of the ratchet causes rotation of the drive tube and lead screw to advance the plunger.

In some embodiments, the actuator lever pivots about a pin.

In some embodiments, an adhesive patch is configured to retain the ambulatory infusion pump on a user's body.

In embodiments, an ambulatory infusion pump can include a reservoir configured to contain a medicament, a syringe assembly including a plunger configured to dispense medicament from the reservoir and a ratchet wheel and pawl mechanism mechanically linked to the syringe assembly. A shape memory wire can be mechanically linked with the ratchet and pawl mechanism such that actuation of the shape memory wire shortens the shape memory wire to cause the shape memory wire to move the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir.

In some embodiments, the pawl pulls on the ratchet wheel when the shape memory wire is actuated.

In some embodiments, the pawl pushes the ratchet wheel when the shape memory wire is actuated.

In some embodiments, the ratchet wheel comprises a plurality of teeth and wherein a distance between each tooth corresponds to the predetermined amount of medicament.

In some embodiments, each actuation of the shape memory wire causes the pawl to move a single tooth along the ratchet wheel.

In some embodiments, the pawl includes an elongate aperture configured to fit around a portion of the plurality of teeth of the ratchet wheel.

In some embodiments, an actuator lever is configured to cause a corresponding movement of the pawl when moved by the shape memory wire, and a spring mechanically is linked to the actuator lever to aid in returning the actuator lever to an original position following actuation of the shape memory wire.

In some embodiments, the actuator lever pivots about a pin.

In some embodiments, an adhesive patch is configured to retain the ambulatory infusion pump on a user's body.

Embodiments of the present disclosure include components capable of and methods using wired and wireless transmission and receipt of signals for exchange of information and commands between and among any of the components as described herein, including, e.g., between a pump and a smartphone; among a pump, a CGM and a smartphone; between a dedicated remote controller and a pump; among a dedicated remote controller, a CGM and a pump; among a dedicated remote controller, a BGM and a pump, and other combinations as would be contemplated by those of skill in the art.

Although embodiments described herein may be discussed in the context of the controlled delivery of insulin, delivery of other medicaments, singly or in combination with one another or with insulin, including, for example, glucagon, pramlintide, etc., as well as other applications are also contemplated. Device and method embodiments discussed herein may be used for pain medication, chemotherapy, iron chelation, immunoglobulin treatment, dextrose or saline IV delivery, treatment of various conditions including, e.g., pulmonary hypertension, or any other suitable indication or application. Non-medical applications are also contemplated.

With regard to the above detailed description, like reference numerals used therein may refer to like elements that may have the same or similar dimensions, materials, and configurations. While particular forms of embodiments have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the embodiments herein. Accordingly, it is not intended that the invention be limited by the forgoing

DETAILED DESCRIPTION

The entirety of each patent, patent application, publication, and document referenced herein is hereby incorporated by reference. Citation of the above patents, patent applications, publications and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or date of these documents.

Modifications may be made to the foregoing embodiments without departing from the basic aspects of the technology. Although the technology may have been described in substantial detail with reference to one or more specific embodiments, changes may be made to the embodiments specifically disclosed in this application, yet these modifications and improvements are within the scope and spirit of the technology. The technology illustratively described herein may suitably be practiced in the absence of any element(s) not specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof and various modifications are possible within the scope of the technology claimed. Although the present technology has been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be made, and such modifications and variations may be considered within the scope of this technology.

INFUSION PUMPS AND METHODS WITH SHAPE MEMORY WIRE DRIVEN SYRINGE MECHANISM

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