Wearable pump infusion system

Abstract

To provide a wearable pump infusion system.SOLUTION: A wearable pump infusion assembly comprises: a housing for selectively supporting a vial which contains a medicament to be delivered to a patient; and a patient support member for supporting the housing on the patient. A bottle connector mounted in the housing comprises: a hollow needle which punctures a seal on the vial, and receives the medicament from the vial; and a connector which is in fluid communication with the hollow needle. The wearable pump infusion assembly also comprises a flexible IV tube and a peristaltic pump. The flexible IV tube has: a first end connected to the connector; a second end connected to another connector; and a center part extending between the first and second ends. The peristaltic pump includes multiple plunger elements which selectively engage with the center part of the flexible IV tube, the plunger elements compress or loosen the center part of the flexible IV tube to draw the medicament from the vial.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 601,881, filed on November 22, 2023, entitled "Hand - Held Ambulatory Pump Infusion System", U.S. Provisional Patent Application No. 63 / 601,882, filed on November 22, 2023, entitled "Clip - On Pump Infusion System", and U.S. Provisional Patent Application No. 63 / 612,658, filed on December 20, 2023, entitled "Wearable Pump Infusion System", the entire contents of each application being incorporated herein by reference.

[0002] The present invention relates to a system for performing intravenous (IV) administration of drugs, and more particularly, to a pump system that enables improved flow control of drugs in an IV bag or IV bottle used in an out - of - facility environment.

Background Art

[0003] Medical pumps such as infusion pumps are known for performing computer - controlled delivery of solutions of drugs, vitamins, minerals, or other nutrients or supplements (hereinafter "drugs") over a period of time. One type of infusion pump is an intravenous (IV) pump. Accurate delivery of IV drugs to a patient can be achieved by an IV pump, for example, an IV pump supported on a pole stand holding an elevated IV bag or IV bottle. An IV tube from the IV bag or IV bottle is passed through the pump and communicates with a needle at the end of the IV tube for insertion into the patient. And by the operation of the IV pump, controlled measurement of the IV fluid can be performed.

[0004] (For example, in the delivery of drugs to patients in a walkable environment) Portable IV pumps capable of performing similar measurements are also known. Such pumps include a battery, which powers the pump and enables the patient to be mobile. In some cases, the pump can be light enough to be worn by the patient, for example, light enough to be worn on a belt that also holds an IV bag or IV bottle.

[0005] When IV fluid delivery is required outside the in-facility environment, conventional gravity feeds of IV fluid are reliable, in which case the height of the IV bag or IV bottle is adjusted to obtain the desired flow rate, and visual monitoring is performed, for example, by counting the number of droplets in a transparent chamber attached to the IV tube.

[0006] U.S. Patent Application No. 17 / 520,182, filed on November 5, 2021, titled "Clip-On Flow Control for IV Lines", which is incorporated herein by reference, describes a "clip-on" flow controller for IV lines that automatically controls the flow rate over a range of pressures using a self-contained valve and flow sensor. By eliminating the pump, a lightweight system with a long operating life can be produced, and by being a self-standing system on the IV line, in-facility-level flow accuracy can be achieved without having to lift the IV bag precisely or monitor it carefully.

[0007] Other infusion pumps other than IV pumps may also be used for drug delivery to patients. Recently, battery-powered compact infusion pumps have become available, which enable the patient to remain active (walkable), for example, remain active (walkable) in a home environment away from the clinic or hospital during treatment.

[0008] Typically, a medicament is provided in a pharmaceutical container (e.g., an IV bag or an IV bottle / vial), which may be connected to an IV tube, and the IV tube is attached to a needle or port that communicates with the patient. A nurse or other healthcare provider caring for the patient receives the medicament, verifies that the description of the medicament is correct, and inputs the desired dosage and flow rate into the pump. Then, the IV tube is disposed within a portable pump and assembly disposed within a pack or other carrying means, and the pack or other carrying means may be worn and held by the patient. The medicament can be delivered until the full dosage is completed while the patient proceeds with normal life activities. And the patient may return the assembly to the nurse or healthcare provider, and the nurse or healthcare provider may provide a new bag of medicament and IV tube, and reprogram the pump for the next treatment.

[0009] Pumps suitable for ambulatory use can be costly to operate in total, and to some extent this is due to the healthcare costs required for a nurse or healthcare provider to verify the medicament, program the pump at the prescribed dosage and flow rate, and load an IV tube cartridge into the portable pump for each medicament delivery. This process is repeated each time a new container of medicament needs to be loaded, thereby increasing the transportation costs for the patient or healthcare provider between the hospital or clinic and the patient's home.

[0010] Also, because high precision is required, the required plastic IV tube cartridges or pumps can be heavy and large, which acts unfavorably on the cost of delivering medicaments with an IV pump worn by the patient. Furthermore, heavy and large plastic materials can make it difficult to attach and remove replaceable IV tube cartridges. This is because a large force is required to compress the IV tube to release the anti-free flow lock and properly install the IV tube.

[0011] U.S. Patent No. 10,869,963, entitled "Low-cost ambulatory medical pump", which is incorporated herein by reference, describes a low-cost ambulatory medical pump with reduced life-limited parts combined with a pump lockout that defines a safe operating limit and prevents reuse after exceeding that limit. Improvements to the IV tube clamp section minimize the length of the unsupported clamp structure and implement a dual-lock system to prevent accidental clamp release.

[0012] U.S. Patent No. 11,712,512, entitled "Ambulatory medical pump cartridge locking system", which is incorporated herein by reference, describes a low-cost ambulatory medical pump with an improved IV tube cartridge attachment that can be held with one hand, requires no force to remove, and prevents accidental release of the IV tube cartridge. A rotatable side lever minimizes the force required to move the locking element against the spring biasing force that biases the locking element to the locked position.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0013] The inventors of the present application have found that if patients can install their own drug containers and IV tubes on a portable pump, it can significantly reduce the time of medical staff and the moving costs of patients. For example, in situations where it is not easy for patients to move to a hospital or clinic, and / or where access to visiting medical staff is limited (for example, when patients live in remote areas), it would be desirable to install at home. In such situations, it is convenient that new containers containing drugs and IV tubes are shipped or delivered to the patient's home, and the patient can install the new containers containing drugs and IV tubes by themselves at home without the assistance of medical staff.

MEANS FOR SOLVING THE PROBLEMS

[0014] The present invention provides a walking pump intended to enhance the availability and acceptability of ambulatory infusion for an IV pump worn by a patient. The pump has a separable housing component, namely, (1) a reusable pump housing having the important mechanical components of the pump, (2) a disposable drug holder supporting a pre-loaded drug container, and an IV tube cartridge having an IV tube made of less material and capable of reducing operating costs. By mounting each connector of the IV tube cartridge and the pump housing on the opposite long edges of the housing respectively to facilitate precise alignment of the IV tube and the pumping element, good dimensional stability can be achieved.

[0015] The walking pump is connectable to one or more disposable drug containers (e.g., IV bottles or vials) held within the disposable drug holder. The disposable drug container is held by a lightweight rigid housing of the drug holder to facilitate attachment of the disposable drug holder to the walking pump. The disposable drug holder can hold one or more disposable drug containers of different sizes (i.e., large and small) in communication with the pumping element of the walking pump so as to be connectable to the IV tube. The disposable drug holder supports a pump connector, and the pump connector is an IV tube cartridge having an IV tube guide channel for holding the IV tube, which is easily placed over and fitted into the bottom of the walking pump to facilitate peristaltic pumping of the liquid drug through the IV tube. Both ends of the IV tube may include a drug container connector at the first end for flowing the liquid drug from the container in one direction, and an IV tube connector at the second end for connecting the liquid drug to the IV tube reaching the patient through a needle or a port or the like.

[0016] A lightweight pump system with a long operating life can be produced, and since it is a self - supporting system on the IV tube, facility - level flow accuracy can be achieved without precisely lifting or carefully monitoring the IV container. The simplified peristaltic pump can be comfortably worn by the patient and enables precise flow control through built - in flow sensing. The disposable IV tube cartridge is self - supporting on the IV tube, so for example, a drug container can be worn around the patient's neck in an upside - down position to utilize natural gravity feed. The peristaltic pump can be removed from the drug holder and reused with another drug container / drug holder. In some embodiments, the drug holder is disposable and can be discarded along with the drug container after use. Thus, while the drug container component is disposable, the peristaltic pump is reusable, thereby minimizing the overall cost of the system.

[0017] According to one embodiment of the present invention, a wearable pump infusion assembly includes a housing configured to selectively support a vial containing a drug to be delivered to a patient, a patient support member removably mounting the housing to the patient, and a bottle connector mounted within the housing. The bottle connector includes a hollow needle that pierces a seal on the vial when the vial is inserted into the housing and receives the drug from the vial. The bottle connector also includes a connector in fluid communication with the hollow needle to receive the drug from the vial. The pump infusion assembly also includes a flexible IV tube and a peristaltic pump. The flexible IV tube has a first end connected to a connector on the bottle connector, a second end connected to another connector, and a central portion extending between the first end and the second end. The peristaltic pump includes a plurality of plunger elements that selectively engage the central portion of the flexible IV tube, and the plunger elements compress and release the central portion of the flexible IV tube to draw the drug out of the vial. The patient support member may be a neck strap, a belt, or a clip.

[0018] According to another aspect of the present invention, the wearable pump infusion assembly includes an opening that at least partially defines a fluid communication passage between the ambient environment outside the vial and the internal space of the vial. A hydrophobic filter is provided in the fluid communication passage to allow air to pass from the ambient environment into the vial and to prevent the drug from exiting through the opening.

[0019] According to yet another aspect of the present invention, the wearable pump infusion assembly includes a lock assembly that engages the neck of the vial, pulls the vial onto the hollow needle of the bottle connector, and secures the vial within the bottle connector. The lock assembly includes a first hinged latch on a first side of the housing and a second hinged latch on a second side of the housing, the second side being opposite the first side.

[0020] According to yet another aspect of the present invention, the housing of the wearable pump infusion assembly includes a first portion and a second portion. The first portion has a first interlock element, at least one vial holding member for receiving the vial, a bottle connector mounted within the housing, and a flexible IV tube mounted within the bottle connector. The second portion includes a second interlock element that is complementary to the first interlock element, and the first and second interlock elements hold the first and second portions of the housing together. The second portion of the housing also includes an electronic circuit housing that houses a controller for the wearable pump infusion assembly. The second portion of the housing may be reusable with a plurality of first portions of the housing.

[0021] According to yet another aspect of the present invention, the electronic circuit housing includes at least one selection device for adjusting a desired flow rate of the agent from the vial and at least one flow sensor for detecting an actual flow rate of the agent from the vial. The controller is operative to receive a feedback signal from the at least one flow sensor and to achieve the desired flow rate by adjusting, in response to the feedback signal, the speed at which the plunger element engages the central portion of the flexible IV tube. The selection device may be at least one selection button actuated by the patient to adjust the desired flow rate. Optionally, the selection device may be at least one selection switch within the electronic circuit housing for adjusting the desired flow rate.

[0022] According to another embodiment of the present invention, a method of delivering an agent to a patient includes inserting a vial containing the agent to be delivered to the patient into a housing. A bottle connector is mounted within the housing and includes a hollow needle that pierces a seal on the vial and receives the agent from the vial when the vial is inserted into the housing, and a connector in fluid communication with the hollow needle for receiving the agent from the vial. A patient support member for supporting the housing on the patient is placed on the patient. When a button on the user interface is pressed, treatment of the patient is initiated and the agent is delivered to the patient by a peristaltic pump and a flexible IV tube. The flexible IV tube has a first end connected to the connector, a second end connected to another connector, and a central portion extending between the first end and the second end. The peristaltic pump includes a plurality of plunger elements that selectively engage the central portion of the flexible IV tube, and the plunger elements compress and release the central portion of the flexible IV tube to draw the agent from the vial.

[0023] These specific objectives and advantages may apply only to some embodiments included in the claims and thus do not define the scope of the present invention.

[0024] Various exemplary embodiments of the invention disclosed herein are shown in the accompanying drawings, in which like reference numerals represent like elements throughout, and the accompanying drawings are as follows.

[0025] In describing the various embodiments of the present invention shown in the drawings, specific terms are used for clarity. However, the present invention is not limited to the specific terms so selected, and each such specific term is intended to include all technical equivalents that operate in a similar manner to achieve a similar purpose. For example, terms such as "connected" and "attached" are often used. These are not limited to direct connections, but include connections through other elements, and such connections are recognized by those skilled in the art as being equivalent.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0027] In the following description, various features and advantageous details of the inventive subject matter disclosed herein will be described in more detail with reference to the non-limiting embodiments described in detail.

[0028] Referring to FIGS. 1 and 2, the wearable pump assembly 10 according to the present invention may comprise a rigid pump housing 12, which is constructed of, for example, an injection-molded thermoplastic material and has selective interlock side wall elements opening towards a separate upper electronic circuit portion 16 and a lower IV cassette portion 17 that holds an IV tube 18. The upper electronic circuit portion 16 receives a short IV tube 18 held by the lower IV cassette portion 17, enabling a peristaltic pumping element to contact the IV tube 18 (which will be described in detail later). The upper electronic circuit portion 16 and the lower IV cassette portion 17 are in proximity to each other, holding the IV tube 18 within the rigid pump housing 12, and the IV tube 18 passes through the rigid pump housing 12 along an axis 14 and exits from an end on the opposite side of the rigid pump housing 12.

[0029] Referring also to FIG. 3 next, the lower IV cassette portion 17 to which the IV tube 18 is attached may comprise a retaining collar 19 within upright, longitudinally opposed cassette end walls 101, 103, with opposed, upright, peripherally longitudinally extending side walls 100, 102 separated by the cassette end walls 101, 103. The retaining collar 19 is assembled around the IV tube 18 so as to clamp the IV tube 18 without crushing or blocking the lumen of the IV tube, and is further held along a longitudinal guide wall 20 and an axis 14, whereby the lower IV cassette portion 17 is held on the IV tube 18 without slipping along the IV tube 18. The lower IV cassette portion 17, the upper electronic circuit portion 16, and the components included therein are such that when attached, their weight can be fully supported by the IV tube 18. The longitudinal guide wall 20 may comprise a notch window 21, which enables a peristaltic plunger element 58 of the upper electronic circuit portion 16 to access the IV tube 18 when the upper electronic circuit portion 16 is fitted into the lower IV cassette portion 17 (which will be described in detail later).

[0030] The attachment of the separate upper electronic circuit unit 16 and lower IV cassette unit 17 may be performed by inserting the side wall 104 of the upper electronic circuit unit 16 that extends in the longitudinal direction of the periphery inside the overhang 15 that extends inward of the lower IV cassette unit 17 and extends inward from the side wall 100 that extends in the longitudinal direction, and by restraining the side wall 104 of the upper electronic circuit unit 16 along the side wall 100 of the lower IV cassette unit 17 that extends in the longitudinal direction.

[0031] The upper electronic circuit unit 16 and the lower IV cassette unit 17 can be held in a closed and attached state against the elasticity of the IV tube 18 by side wall latch elements 22 (shown in FIG. 2 in a separated state). The side wall latch elements 22 have a temporary locking function, which is, for example, a temporary locking function in which a cantilever bar 22a that extends outward from the side wall 106 that extends in the longitudinal direction of the upper electronic circuit unit 16 and has a rectangular opening that bends outward is fitted onto a rectangular button 22b that extends outward from the side wall 102 that extends in the longitudinal direction of the lower IV cassette unit 17.

[0032] Each end of the IV tube 18 that extends outward from the lower IV cassette unit 17 may have standard luer locks 26a and 26b, by which each end can be connected, at one end, to a connector that is connected to a vial (i.e., an IV bottle) 32 that is lifted by being connected to a neck strap 33 worn around the patient's neck for (for example) gravity flow, and at the other end, can be connected to a needle set or port 34 or the like attached to the patient (as shown in FIG. 1). The central portion of the IV tube 18 that extends between each end is flexible or elastic for interacting with the plunger element 58 of the peristaltic pump assembly 66 (which will be described in detail later). According to one aspect of the present invention, the central portion of the IV tube 18 is made of a peristaltic tube material of polyvinyl chloride (PVC).

[0033] Generally, the wearable pump assembly 10 is small and lightweight, and for example, in order to be easily supported by the IV tube 18 and the luer locks 26a and 26b without causing excessive strain or damage to the IV tube 18 or damage to the IV bottle 32 or discomfort to the patient, the longest dimension is less than 4 inches, desirably less than 3 inches, the total weight is less than 8 ounces, and desirably less than 6 ounces.

[0034] Next, referring to FIGS. 2 and 3, the upper electronic circuit portion 16 may include a microcontroller 54, and the microcontroller 54 is an electronic computer having a self - contained non - volatile memory 55 that holds an operating program 57 and necessary storage variables (described later). The non - volatile memory may include, for example, flash memory and / or read - only memory, or other similar non - volatile memory as required depending on the situation, and the data values that can be stored therein are retained even when there is no power.

[0035] The microcontroller 54 may include control lines for the pump assembly 66 of the upper electronic circuit portion 16. The pump assembly 66 has a built - in DC electric motor 56 that operates, for example, to actuate a peristaltic plunger element 58 through a gear device. The peristaltic plunger element 58 can push the fluid passing through by compressing the elastic central portion of the IV tube 18 through the window 21. As is understood in the art, generally, the peristaltic plunger element 58 extends in a serpentine wave shape to compress and release the tube to move the fluid passing through.

[0036] The microcontroller 54 also has various input and output lines, and these input and output lines communicate, for example, with a user interface on the upper surface 52 of the upper electronic circuit portion 16 of the housing 12. The user interface makes the low battery indicator light 36 visible, and the low battery indicator light 36 warns the user that the battery is in a low battery state and that the battery needs to be charged or replaced (described later). By means of the membrane button 38, it may be possible to adjust the flow rate and the maximum flow rate through the IV tube 18 (described later). Further, by means of the power on / off switch 42, the wearable pump assembly 10 can be turned off for storage and the like, and the on state is indicated by the visible indicator light 44 lighting up. An optional charging port may also be provided (described later). The piezoelectric acoustic transducer 40 emits an audible sound. This is an audible sound that warns, for example, when the connection between the upper electronic circuit portion 16 and the lower IV cassette portion 17 is incomplete, or when the flow rate stops or falls below a predetermined lower limit (due to, for example, kinking or blockage of the IV tube 18). As described later, the flow sensor 60 can also detect air bubbles. The pump assembly 66 is said to optionally include any combination of the computer-controlled functions described above or not.

[0037] In one embodiment, the upper electronic circuit portion 16 may hold a long-life battery 50, and the long-life battery 50 is, for example, a long-life battery with a nominal rating of 10 years (for example, a non-rechargeable lithium thionyl chloride battery of 3.6 volts), whereby the pump assembly 66 is suitable for long-term storage and use in emergency supplies and the like. Alternatively, a standard rechargeable lithium-ion battery or other similar battery that can be charged through the charging port described above may be used. The long-life battery 50 may be wirelessly charged, or may be AC / DC charged from the charging port, or may be a disposable battery that is discarded after being used once.

[0038] The battery 50 may supply power to the microcontroller 54 (through the power on / off switch 42 shown in FIG. 2), and the microcontroller 54 controls the motor 56 held by the upper electronic circuit section 16 and communicates with the low battery indicator lamp 36, the membrane button 38, and the acoustic transducer 40 through the interconnection wiring 41. The motor 56 operates to activate the peristaltic plunger element 58 in the upper electronic circuit section 16 through a gear device, and the peristaltic plunger element 58 can compress the IV tube 18 and push the fluid passing through it when the upper electronic circuit section 16 is attached to the lower IV cassette section 17.

[0039] The peristaltic plunger element 58 may extend toward the IV tube 18 through a window 21 formed through the longitudinal guide wall 20 to compress the IV tube 18 when the upper electronic circuit section 16 and the lower IV cassette section 17 are in a closed position. The peristaltic plunger element 58 extends in a wavy and meandering manner to compress and loosen the tube and move the fluid passing through it at a desired flow rate.

[0040] In one embodiment, the lower IV cassette section 17 holds the IV tube 18, and the IV tube 18 may include two outermost rigid vinyl tube portions 62, each of which is attached to the luer locks 26a and 26b and is joined to a more flexible elastic central tube portion 64, which is flexible and suitable for engaging with the peristaltic plunger element 58 when the upper electronic circuit section 16 is attached to the lower IV cassette section 17. Optionally, the central tube portion may be made of a PVC peristaltic tube material.

[0041] This operation of the motor 56 and the peristaltic plunger element 58 may follow a feedback loop that uses a flow sensor 60 incorporated into the upper electronic circuit portion 16. The microcontroller 54 receives a desired flow rate that represents the flow rate when the drug is delivered from the vial. According to one aspect of the present invention, the user may adjust the flow rate using the membrane button 38 of the electronic circuit portion 16. An indicator (e.g., a series of light-emitting diodes (LEDs)), a dial, or a display unit may display the flow rate. The user may set the flow rate to the desired flow rate by pressing an up button or a down button. Optionally, the microcontroller 54 may store a series of various settings, and the desired setting may be identified by letters, numbers, or the display of the drug and flow rate on the display. By pressing the membrane button 38, it is possible to switch between various settings until the desired setting is selected. The pharmacist may assist the patient in setting the flow rate to the correct flow rate, or may provide instructions regarding the appropriate settings of the device along with the vial.

[0042] According to another aspect of the present invention, the electronic circuit portion 16 may include a selection switch inside the housing. The selection switch may include one or more variable resistors, and those variable resistors are adjusted to achieve the desired flow rate. Optionally, a series of selection switches (e.g., dual in-line package (DIP) switches) may be set to the desired positions for setting the desired flow rate. The manufacturer or the pharmacist may be trained to set the selection switch according to the specific drug to be administered. The electronic circuit portion 16 may be used with multiple vials of the same drug after being set once. Optionally, the patient may return the electronic circuit portion 16 to the pharmacist for adjustment of the settings of the electronic circuit portion 16 for use with another drug.

[0043] Each flow sensor 60 generates a feedback signal corresponding to the measured flow rate of the drug passing through the respective flow sensor. This feedback signal is passed to the microcontroller 54. The microcontroller may compare the measured flow rate with the desired flow rate and accelerate or decelerate the peristaltic pump assembly 66 so that the desired flow rate is achieved.

[0044] For example, under various pressures within a certain range of the IV fluid in the IV tube 18, the motor 56 may adjust the speed of the peristaltic plunger element 58 so that the flow rate becomes steady at the set point of the feedback loop according to the flow rate measured by the fluid sensor 60 through the IV tube 18. For example, an upstream pressure sensor and a downstream pressure sensor may be used to operate the pump correctly by detecting abnormal pressures. Generally, the flow sensor 60 may comprise a spring-loaded plunger that presses against the outer wall of the IV tube 18 to detect pressure. It is understood that these sensors may be omitted in some embodiments to simplify the operation.

[0045] Referring back to FIG. 1, the housing 12 can be completely self-supporting on the IV tube 18, but the IV bottle 32 may be held by a neck strap 33 attached to the IV bottle 32 (e.g., wrapped around and fixed to the bottom of the IV bottle 32), while the IV bottle 32 is suspended upside down and hung around the patient's neck to facilitate gravity flow. Being self-supporting in this context means that the pump housing 12 can be supported unrestrictedly on the IV tube 18. For example, the IV tube 18 is vertically suspended from the IV bottle 32 without the IV tube expanding more than necessary or being damaged. Optionally, other patient support members may be provided, and the patient support member is a device used to support the pump assembly 10 on the patient. Suitable patient support members include, for example, belts, adjustable straps, clips, etc., which enable the pump assembly 10 to be "worn" on the patient while the patient is moving around.

[0046] In use, an IV tube 18 is pre-installed in the lower IV cassette portion 17. The IV tube 18 optionally has a soft central tube portion 64 made of silicone rubber or PVC peristaltic material. Further, the ends of the IV tube 18 are attached to connectors via luer locks 26a and 26b. The pre-assembled lower IV cassette portion 17 may be prepared by a pharmacist and sent to the patient together with a pre-filled drug container or IV bottle 32.

[0047] Referring briefly to FIG. 4, a bottle connector 88 may be pre-attached to the luer lock 26a, which enables the patient to connect the IV bottle 32 to the luer lock 26a and allows the flow from the IV bottle 32 to reach the IV tube 18 through the luer lock 26a.

[0048] The bottle connector 88 may be a cylindrical cap that surrounds a central hollow needle 92 extending along a needle shaft 90 and is attached by fitting over the cap of the IV bottle 32. For example, it has three axial slots 93 extending along the needle shaft 90, and the upper portion 95 is divided into cantilever portions 96a, 96b, 96c. These cantilever portions are flexible both outwardly at their upper rim 97 and inwardly toward the needle shaft 90. To provide further flexibility, further axial slots 98 extending along the needle shaft 90 may be formed in the upper portion 95 below the upper rim 97.

[0049] The cantilever portions 96a, 96b, 96c spread over and fit over the cap of the drug container and over the cap of the IV bottle 32. Further, the seal of the cap of the IV bottle 32 is pierced by the hollow needle 92, and the hollow needle 92 extends through the seal to enable the liquid drug to be drawn from the internal space of the IV bottle 32. The bottle connector 88 may be vented for removal of air bubbles.

[0050] As the fluid in the IV bottle 32 flows through the hollow needle 92 that penetrates the bottle connector 88, the bottom portion 99 of the bottle connector 88 supports the tube connector 94 so as to enable a leak - free communication between the hollow needle 92 and the bottle connector 88. The bottle connector 88 and / or the luer lock 26b may include a stop valve that stops the flow before the desired drug delivery. The IV bottle 32 may be suspended from the patient's neck using the neck strap 33 attached to the inverted IV bottle 32 during drug delivery.

[0051] Referring again to FIGS. 2 and 3, the pre - assembled lower IV cassette portion 17 is received by the patient, and the upper electronic circuit portion 16 is fitted over the lower IV cassette portion 17 to form the closed pump housing 12. Accordingly, the peristaltic plunger element 58 extends outwardly from the longitudinally extending side wall 104 facing the peripherally longitudinally extending side wall 106 and is inserted under the inwardly extending overhang 15 of the lower IV cassette portion 17, enabling the peristaltic plunger element 58 to extend through the window 21 of the longitudinally guiding wall 20. The latch element 22b of the peripherally longitudinally extending side wall 106 and the latch element 22a of the upright peripherally longitudinally extending side wall 102 are fitted together, temporarily locking the upper electronic circuit portion 16 and the lower IV cassette portion 17 to each other.

[0052] When switched on, the pump assembly 66 may trigger a self - test to verify the operation of the peristaltic plunger element 58, which is performed, for example, by monitoring the over - current or switch limits when the motor moves the peristaltic plunger element 58. The flow rate may be pre - loaded, and the pump assembly 66 may start operating immediately (e.g., for emergency use). Alternatively, the desired flow rate may be set using the membrane button 38.

[0053] Of course, the flow rate implementation may be performed by a mobile device such as a separate control computer, smartphone, or tablet (hereinafter referred to as a "smart device") that is securely linked to the microcontroller 54. For example, it may be performed through a short-range wireless communication device such as a Bluetooth or Wi-Fi connection so that each keyboard, display, and sensing element can be used. In this specification, "short-range wireless communication" typically means a wireless technology that operates within a distance range of 0 to 5 cm and does not operate at distances exceeding approximately 1 m. In this case, a single mobile device such as a phone equipped with the iPhone (registered trademark) or Android operating system is securely linked to the microcontroller 54 of the upper electronic circuit unit 16.

[0054] The flow rate during infusion is monitored by the flow sensor 60 and controlled by the controller 54. When the flow is blocked or obstructed, or when air bubbles are detected (in which case the pinch valve closes), a warning sound is emitted.

[0055] If the desired total dose has been input by the user, at the end of the dose delivery (obtained by integrating the flow rate), the peristaltic plunger element 58 is stopped and a signal is sent to the user.

[0056] At the end of the infusion, the lower IV cassette unit 17 to which the pre-installed IV tube 18 is connected to the IV bottle 32 may be removed from the upper electronic circuit unit 16 and replaced with a new lower IV cassette unit 17 having aseptic properties. The previously used lower IV cassette unit 17 to which the pre-installed IV tube 18 is connected to the IV bottle 32 is discarded. The microcontroller 54 may track the battery level to confirm that sufficient capacity exists for the next infusion, which may be done, for example, by counting the number of motor cycles, battery age, number of charges, etc. Accordingly, a single electronic circuit unit 16 may be reused for multiple IV cassette units 17, thereby reducing the overall cost per dose.

[0057] In at least some embodiments, the microcontroller 54 may check the battery level before each new drug delivery operation or operation of the motor 56 and flow sensor 60 to determine whether the battery level or remaining battery life is sufficient for typical drug delivery. The controller may perform an internal time - ampere - hour conversion based on the current drain of the microcontroller 54, motor 56, and flow sensor 60 to check whether the remaining battery energy is sufficient for drug delivery and compare it to the estimated total ampere - hours of the battery 50. If the battery level is below the required amount, the microcontroller 54 may notify the user that the battery 50 needs to be charged or replaced before operation. The microcontroller 54 may not enable the operation of the motor 56 and flow sensor 60 unless the battery 50 is charged to a level sufficient to prevent an undesirable interruption during delivery.

[0058] In at least some embodiments, the number of uses of the pump assembly 66 may be counted, for example, by the number of IV tube replacements, the number of motor cycles, the battery age, the number of charge cycles, and the accumulation of other means of life tracking, which is for alerting the user or automatically shutting off when the pump assembly 66 has reached its intended service life limit, when it should no longer be used, and when it should be discarded. Thus, the pump assembly 55 is intended to be a disposable device with a limited service life.

[0059] In an alternative embodiment shown in FIGS. 5 and 6, the wearable pump assembly 10 may include a disposable support housing 110, which replaces the lower IV cassette portion 17 of FIGS. 1-3, and supports the IV tube 18 that has been pre-installed and the removable upper electronic circuit portion 16 so that they are engaged in proximity to a vial (i.e., IV bottle) 32 that supplies a liquid drug. All of these are supported on the support housing 110. The upper electronic circuit portion 16 is removably attached to the support housing 110 such that the peristaltic plunger element 58 of the upper electronic circuit portion 16 is aligned with the pre-installed IV tube 18 that passes through the support housing 110 along the axis 14.

[0060] Referring particularly to FIG. 5, the support housing 110 may be a generally L-shaped frame having a horizontal platform 112 and a vertical wall 114. The horizontal platform 112 extends horizontally so as to receive the inverted IV bottle 32 thereon, and the vertical wall 114 extends upward from the back of the horizontal platform 112 to provide a rear support wall for receiving the upper electronic circuit portion 16. When the IV bottle 32 and the upper electronic circuit portion 16 are supported by the support housing 110, fluid flows from the IV bottle 32 through the pre-installed IV tube 18, through the support housing 110, and is further pumped to, for example, a needle set or port 34 attached to the patient at the other end, allowing it to flow through the needle or port (as shown and described in FIG. 1), and they are positioned in proximity to each other.

[0061] The horizontal platform 112 may include a locking assembly 116 that locks the neck 113 of the IV bottle 32 to the horizontal platform 112. The locking assembly 116 may include a left pair of a front vertical pin 118a and a rear vertical pin 118b, which support a horizontal pin 120 extending along the left side surface of the horizontal platform 112 at their respective upper ends. The locking assembly 116 may further include a right pair of a front vertical pin 122a and a rear vertical pin 122b, which support a horizontal bar 124 extending along the right side surface of the horizontal platform 112 at their respective upper ends.

[0062] The horizontal pins 120, 124 receive hinged latches 126, 128 respectively, and the latches 126, 128 pivot about the horizontal pins 120, 124. When the inward ends 130 extend downward, they engage with the neck 113 of the vial (i.e., IV bottle) 32, and when the inward ends 130 extend upward, the engagement with the neck 113 of the vial (i.e., IV bottle) 32 is released. Specifically, when the hinged latches 126, 128 engage with the neck 113 of the vial 32, the hooks 131 at the inward ends 130 of the hinged latches 126, 128 catch on the sterile cap 132 on the neck 113 of the vial 32 and apply a downward force to the sterile cap 132 against the pre-installed bottle connector 188 supported on the horizontal platform 112. When the hinged latches 126, 128 are pushed in and locked, due to the force applied to the neck 113 of the vial 32, the vial 32 engages with the central needle 92, and the central needle penetrates through the seal or membrane covering the mouth of the vial 32 and enters the internal space 35 of the vial. The hinged latches 126, 128 also fix the vial 32 to the bottle connector 188 within the disposable support housing 110.

[0063] The opposite ends 133 of the hinged latches 126, 128 extend outwardly and allow the user to push the opposite ends 133 inwardly and downwardly to release the hook 131 from engagement. The hook 131 is disengaged from the sterile cap 132 on the neck 113 of the IV bottle 32 in the disengaged position, and the IV bottle 32 can be removed from the horizontal platform 112. To make the engaged position the default position, the hinged latches 126, 128 in the engaged position may be biased by a spring (not shown).

[0064] According to one embodiment of the present invention, the bottle connector 188 may be considered to be described in the same manner as the bottle connector 88 shown in FIG. 4 above, but the hollow needle 92 may extend above the upper rim 97 for easier engagement with the fluid, and the tube connector 94 connected to the IV tube 18 may be an L-shaped, T-shaped, or 90-degree connector that extends horizontally along the horizontal platform 112.

[0065] According to another embodiment of the present invention, the bottle connector 188 may include a compliant sheet 193, and the vial 32 is fixed to the compliant sheet 193. Referring to FIG. 7, the bottle connector 188 includes a first compliant member 189 and a second compliant member 192. The first compliant member 189 has an upper portion 190 with a tapered outer periphery, and the upper portion 190 is configured to fit into the neck 113 of the vial 32 and guide the vial onto the first compliant member 189. The first compliant member 189 includes a lower portion 191 with an annular outer periphery, and the lower portion 191 is configured to fit into the neck 13 of the vial 32 and establish a seal between the first compliant member 189 and the inner periphery of the neck 13 of the vial 32. It is contemplated that the diameter of the lower portion 191 may be slightly larger than the diameter of the inner periphery of the neck 113 of the vial 32. Since the hinged latches 126, 128 pull the vial 32 onto the first compliant member 189, the lower portion 191 can be compressed to fit into the inner periphery of the neck 113 of the vial 32 and make the sheath therebetween more secure. The second compliant member 192 is generally annular and has an outer periphery larger than the outer periphery of the first compliant member 189. The upper surface 193 of the second compliant member 192 defines a seat on which the vial 32 is pressed by the latches 126, 128 and stabilized.

[0066] Each of the first and second compliant members 189, 192 includes an opening therethrough, and the tip of the hollow needle 92 extends through this opening. The lower end of the hollow needle 92 extends downward through the first and second compliant members 189, 192 to the tube connector 94, thereby defining a fluid communication path between the hollow needle and the tube connector 94. By connecting the first end of the IV tube 18 to the tube connector 94, a fluid flow path is formed from the inside of the vial 32 through the hollow needle 92 and the tube connector 94 to the pre-installed IV tube 18, and the IV tube 18 further engages with the upper electronic circuit portion 16 (described later). An upright side retaining wall 134 may further be located on the side to hold the bottle connector 188 on the horizontal platform 112.

[0067] A lower retaining ring 136 extending forward from the vertical wall 114 and forming an upwardly exposed circular opening extends around the upper rim 97 of the bottle connector 188 and the narrower portion of the inverted IV bottle 32 to assist in holding the IV bottle 32 in an inverted position on the horizontal platform 112.

[0068] An upper retaining ring 138 extending forward from the vertical wall 114 and forming an upwardly exposed circular opening extends around the wider portion of the inverted IV bottle 32 to hold the IV bottle 32 on the horizontal platform 112 along the vertical wall 114. The upper retaining ring 138 may support upwardly extending retaining fingers 139 that extend upward along the body of the IV bottle 32.

[0069] The opening of the upper retaining ring 138 is generally larger than the opening of the lower retaining ring 136, which is for circumscribing around the body of the lower portion of the IV bottle 32, while the lower retaining ring 136 circumscribes around the narrowed neck 113 of the upper portion of the IV bottle 32.

[0070] Referring to FIG. 6, the vertical wall 114 supports the attachment of the upper electronic circuit portion 16, whereby the pre-installed IV tube 18 extends from the bottle connector 188 along the upper electronic circuit portion 16, enabling the peristaltic plunger element 58 to engage with the pre-installed IV tube 18. The back surface 141 of the vertical wall 114 may include a rectangular recess 140 that receives the electronic circuit portion 16 in the vertical wall 114 and is further constrained by the upper retaining wall 142, the lateral left retaining wall 143, the lateral right retaining wall 144, and the back edge of the horizontal platform 112 to hold the upper electronic circuit portion 16 against and supported by the vertical wall 114.

[0071] A hook 145 on the left side of the rectangular recess 140 may be hooked on the left side wall of the upper electronic circuit portion 16, thereby locking its left side to the vertical wall 114.

[0072] The spring-biased latch 146 extends along the right side of the vertical wall 114 and pivots inwardly about a hinge axis 147 extending along its right side, whereby a tab 149 having a receiving hole pivots inwardly to engage a corresponding button 148 along the right side wall of the upper electronic circuit portion 16, thereby locking the upper electronic circuit portion 16 to the vertical wall 114 and pivoting outwardly to disengage from the corresponding button 148 on the right side wall of the upper electronic circuit portion 16. It may be possible to do so. By manually pressing the spring-biased latch 146, it is possible to disengage the corresponding button 148 from the tab 149. To set the engaged position to the default position, the spring-biased latch 146 in the engaged position may be biased by a spring (not shown).

[0073] The vertical wall 114 may support a small notch hole 150 passing therethrough, which allows the pre-installed IV tube 18 to extend from the bottle connector 188 on the front side of the vertical wall 114 to the upper electronic circuit portion 16 on the opposite side of the vertical wall 114.

[0074] A further guide or guide wall 151 extending from the back surface 141 of the vertical wall 114 to the back holds the pre-installed IV tube 18 further aligned and held along the peristaltic plunger element 58 of the upper electronic circuit section 16. These outer guide walls 151a and inner guide walls 151b extend substantially along the left side of the back surface 141 and are located outside and inside the pre-installed IV tube 18, so that the tube can vertically extend upward along the vertical wall 114 to the vinyl tube portion 62. Each vinyl tube portion 62 is attached to the Luer lock 26a as already taught.

[0075] The peristaltic plunger element 58 may extend outward from the upper electronic circuit section 16, whereby the pre-installed IV tube 18 is pushed by the actuating element towards the outer guide wall 151a on the outside of the vertical wall 114. The peristaltic plunger element 58 may extend through the notch window 153 of the inner guide wall 151b to push towards the outer guide wall 151a. Thus, the peristaltic plunger element 58 extends outward from the upper electronic circuit section 16 and engages with the pre-installed IV tube 18 of the support housing 110.

[0076] The support housing 110 may be suspended over the patient's body by the neck strap 33, and the neck strap 33 may be passed through a hole 152 (such as in the upwardly extending retaining finger 139). Thus, the support housing 110 is self-contained, and the IV bottle 32 and the upper electronic circuit section 16 are completely self-supporting by the support housing 110. Optionally, the holes 152 may be arranged roughly vertically so that a belt or strap can be inserted, and the belt or strap is used to fix the support housing 110 to the patient. According to yet another option, a clip for fastening the support housing 110 to the patient may be provided.

[0077] Referring back to FIGS. 5 and 6, in use, the patient may connect the IV bottle 32 to the support housing 110, which is done by inserting the IV bottle 32 downwardly into the upper retaining ring 138 and the lower retaining ring 136 and attaching it to the bottle connector 188. The hinged latches 126, 128 lock the IV bottle 32 to the bottle connector 188 and the horizontal platform 112 by engaging the neck 113 of the IV bottle 32.

[0078] Once the IV bottle 32 is attached to the bottle connector 188, the hollow needle 92 extends through the seal of the sterile cap 132 of the IV bottle 32, enabling the liquid medicament to be withdrawn from the interior space of the IV bottle 32. The bottle connector 188 then feeds fluid to a pre-installed IV tube 18 that extends from the bottle connector 188 to the upper electronic circuit section 16.

[0079] Further, the upper electronic circuit section 16 is attached to the vertical wall 114 by the user, which is done by aligning the upper electronic circuit section 16 in a rectangular recess 140 on the back surface 141 of the vertical wall 114, hanging the hook 145 on the upper electronic circuit section 16, and hanging the spring-biased latch 146 on a corresponding tab 148 along the right side wall of the upper electronic circuit section 16 to lock the upper electronic circuit section 16 to the vertical wall 114, thereby enabling the peristaltic plunger element 58 to engage the pre-installed IV tube 18 for peristaltic pumping.

[0080] To deliver the drug to the patient, the controller 54 adjusts the operation of the plunger element 58 within the pump assembly 66 such that the plunger element 58 engages the IV tube 18 within the pump assembly 10. The pump assembly 66 operates in cooperation with gravity to draw the drug from the vial 32. With the inverted vial 32 inserted into the support housing 110, the drug is at the neck 113 of the vial, next to the hollow needle 92. The plunger element 58 alternately compresses and relaxes the IV tube 18 to draw fluid from the vial 32. Sequential compression of the IV tube 18 by the plunger element 58 pushes the fluid within the tube forward. When the plunger element 58 relaxes the IV tube 18, a vacuum is created within the tube, drawing additional fluid from the vial 32 or from the IV container to which the IV tube 18 is connected. The vacuum draws the drug through the hollow needle 92 and the tube connector 94 within the bottle connector 188. The first end of the IV tube 18 is connected to the tube connector 94, and the plunger element 58 passes the drug through the IV tube 18 and out of the second end of the IV tube 18. A second connector is present at the second end of the IV tube 18, which connects to another IV tube between the pump assembly 10 and the port or needle that delivers the drug to the patient. According to one aspect of the present invention, each of the first and second connectors at the first and second ends of the IV tube 18 is a luer lock connector 26a, 26b.

[0081] To improve the pumping process, it may be desirable to introduce air above the drug within vial 32. As the drug is withdrawn from vial 32, a vacuum will be created above the drug within vial 32. The vacuum within vial 32 can oppose the vacuum generated by pumping assembly 66, thereby reducing the efficiency of the pumping process. An opening 195 may be provided within bottle connector 188 at a location above where the drug exits the bottle connector. According to the illustrated embodiment, the opening around hollow needle 92 is utilized as opening 195 for introducing air from outside the vial. A hydrophobic filter 194 is provided between the bottom of the second compliant member 192 and the seat of bottle connector 188. The hydrophobic filter 194 allows air to pass through but not water. As a result, as the drug is withdrawn from vial 32, the vacuum generated in the upper portion of the vial will draw air from the surrounding environment outside the vial into the internal space 35 of vial 32. By introducing air from outside vial 32 into the portion of internal space 35 emptied by the drug, the pressure on the drug becomes uniform, allowing peristaltic pump assembly 66 to continue withdrawing additional drug from vial 32.

[0082] When the infusion is complete, upper electronic circuit portion 16 may be removed from support housing 110 and reused for another infusion. IV bottle 32 and support housing 110 may be replaced with a new support housing 110 having aseptic properties, and the new support housing 110 may be loaded with a new IV bottle 32 for the next infusion. Accordingly, IV bottle 32 and support housing 110 are disposable for reducing operating costs.

[0083] Next, referring to FIGS. 8 - 11, another embodiment of the present invention is shown. A walking pump 210 according to the illustrated embodiment can operate in combination with a disposable housing 212 that holds an IV tube 214. The disposable housing 212 may hold a drug container 215 (e.g., an IV bottle or vial of the type used to hold an IV solution), and the IV tube 214 comprises a flexible tube that allows the drug to flow from the drug container 215 through a bottle connector 216 and an IV tube connector 217. The IV tube connector 217 may further communicate with a conventional IV tube 213 that is connected to a patient 219 via a needle or port, etc. The IV tube 214 may include a bubble filter that removes entrained air bubbles and limits the need for bubble detection.

[0084] The walking pump 210 comprises a two - part housing having an upper electronic circuit portion 218 and an IV tube cartridge 220 to which it is attachable. The housing of the walking pump 210 houses the IV tube 214 between the upper electronic circuit portion 218 and the IV tube cartridge 220 along the longitudinal axis 222, which is generally the longest dimension of the housing. Being housed in such a manner, the walking pump 210 is capable of pumping liquid through the IV tube 214 by peristaltic action.

[0085] In one embodiment, the walking pump 210 is made lighter than half a pound and preferably smaller than 1.5 inches × 2 inches × 5 inches, which is to make it easy for a patient 219 to carry (e.g., by placing it in a compartment 227 of a pouch 224 that is also sized to accommodate the disposable housing 212).

[0086] The walking pump 210 may be held within the port 224, with the longitudinal side walls 221 and 223 of the compartment 227 of the port 224 closely cradling the corresponding longitudinal side walls of the walking pump 210 and the disposable housing 212 respectively, and the front wall 225 and the rear wall 229 of the compartment 227 of the port 224 closely cradling the corresponding front and rear opposing side walls of the walking pump 210 and the disposable housing 212 respectively. The front wall 225 of the port 224 has a transparent screen 235 that serves as a window, which enables the user to view the liquid crystal display 228 of the walking pump 210 and, optionally, to press the membrane switch push buttons of the user interface 226 of the walking pump 210 through the transparent screen 235.

[0087] Alternatively, the walking pump 210 may be attached to a strap 238 (e.g., by a keyholder or clip attached to a hole at the upper end of the disposable housing 212), thereby enabling the walking pump 210 to be suspended or hung from the patient 219. The strap 238 may be placed around the neck of the patient 219, thereby enabling the walking pump 210 to be suspended from the patient's neck. In this way, the drug container 215 is held in an inverted position, allowing for gravity flow.

[0088] In one embodiment, the housing of the upper electronic circuit unit 218 may have a user interface 226 on its front wall 233. The user interface 226 includes, for example, a liquid crystal display 228 that displays symbols and alphanumeric characters under computer control. The user interface 226 also includes a plurality of membrane switch push buttons 230 that can be actuated by the user. Generally, the push buttons include a limited number of operation buttons. As such buttons, in one embodiment, there are a start push button 230a, a stop push button 230b, and a flow rate push button 230c. The start push button 230a and the stop push button 230b are push buttons for stopping and starting the operation of the pump respectively. The flow rate push button 230c is a push button that circulates the standard flow rate of the menu each time it is pressed, enabling the user to set the maximum pumping flow rate of the walking pump 210 in units of milliliters per hour. As further push buttons, there are a "volume to be infused" push button 230d and an information push button 230e. The "volume to be infused" push button 230d is also a push button that circulates the standard setting each time it is pressed, enabling the user to control the maximum volume to be infused during the treatment protocol. The information push button 230e is a push button that enables the display of detailed information about the pump, including the remaining life of the pump. The push button 230f is a push button that enables turning the device on and off for power saving. The bolus push button 230g is a push button that enables a short-time operation of the pump to deliver a fixed bolus amount of drug controlled by the patient. The user interface 226 of the upper electronic circuit unit 218 may or may not include the liquid crystal display 228, and may or may not include any arbitrary combination of the computer controls described above for the push buttons 230a, 230b, 230c, 230d, 230e, 230f, 230g.

[0089] The walking pump 210 may include a microcontroller 236, which is an electronic computer having a self - contained non - volatile memory 237 that holds an operation program 240 and necessary storage variables (described later). The non - volatile memory may include, for example, flash memory and / or read - only memory, or other similar non - volatile memory required according to the situation, and the data values that can be stored therein are retained even when there is no power.

[0090] The microcontroller 236 also has various input and output lines. These input and output lines communicate with a display 228, for example, to provide display information to the display 228, and communicate with those push buttons 230 to receive data regarding the activation of various push buttons 230 by the user. Further, the microcontroller 236 may have control lines for the pump assembly. The pump assembly has a built - in DC electric motor (not shown) that operates, for example, to activate a peristaltic plunger element 244 through a gear device. The peristaltic plunger element 244 can push the fluid passing through by compressing the accommodated IV tube 214. As is understood in the art, generally, the peristaltic plunger element 244 extends in a wavy meandering manner to compress and release the tube to move the fluid passing through.

[0091] The microcontroller 236 may also communicate electrically with various sensors. For example, an upstream pressure sensor 246 and a downstream pressure sensor 248 may be used to operate the pump correctly by detecting abnormal pressures. Generally, each of the flow sensors 246 and 248 may include a spring - type plunger that presses against the outer wall of the IV tube 214 to detect pressure. In some embodiments, these sensors may be omitted to simplify the operation.

[0092] Power supply to all electrical components within the upper electronic circuit unit 218 may be performed by the mounted battery 249, and the battery 249 may provide the power directly or through a standard power processing circuit such as a regulator. The mounted battery 249 may be wirelessly charged, or may be AC / DC charged from a micro-USB port, or may be a disposable battery that is discarded after being used once.

[0093] Naturally, the user interface 226 elements of the display 228 may be implemented by a mobile device such as a separate control computer, smartphone or tablet (hereinafter referred to as a "smart device") that is safely linked to the microcontroller 236, for example, through a short-range wireless communication device such as a Bluetooth or Wi-Fi connection so that each keyboard, display, and sensing element can be used. In this specification, "short-range wireless communication" means a wireless technology that operates at a distance of 4 cm or less and does not operate at a distance exceeding about 1 m. In this case, a single mobile device such as a phone equipped with an iPhone or Android operating system is safely linked to the microcontroller 236 of the upper electronic circuit unit 218.

[0094] The front wall 233 is provided with a release button or release lever 232 for removing the IV tube cartridge 220 from the attachment.

[0095] Referring also to FIG. 9, the disposable housing 212 of the walking pump 210 holds a drug container 215 intended to be discarded after use by a single patient 219. The disposable housing 212 includes a rigid frame 250, and the rigid frame 250 has a first half 252a and a second half 252b that are tightly joined in a closed state along a separation surface 254. In one embodiment, the rigid frame 250 may be made of a medical plastic polymer (e.g., polyethylene, polypropylene, PMMA, PVC, polyamide, ABS, or polycarbonate) (e.g., having a thickness of 0.01 to 0.1 inches). The rigid frame 250 may be transparent so that the drug container 215 is more visible to the user.

[0096] Each of the first half 252a and the second half 252b may form a circular notch that defines a large drug container volume 255 and a small drug container volume 256 between the first half 252a and the second half 252b within the disposable housing 212. The rigid frame 250 generally has horizontal limiting walls that extend along the separation surface 254 and are defined by an upper arm 258 and a lower arm 260, and are joined by a vertical limiting wall that extends vertically to the upper arm 258 and the lower arm 260 and is defined by a bridge member 261.

[0097] A recess may be formed in each of the retaining walls forming the upper arm 258 and the retaining walls forming the lower arm 260, and these recesses respectively surround a large chemical container volume 255 and restrict movement by abutting against the outer peripheral portion of the chemical container 215a held within the large chemical container volume 255. For this purpose, the first half 252a and the second half 252 are joined to form an upper arm 258 that holds a circular recess 262 (extending away from the lower arm 260) that receives the circular bottom 270 of the chemical container 215a, and a lower arm 260 that holds a circular recess 264 (extending away from the upper arm 258) that surrounds a port 266 (e.g., the cylindrical neck and cap of an IV bottle) that receives the circular uppermost portion 272 of the chemical container 215a. The port 266 has an opening that allows the bottle connector 216 to be connected to the neck of the IV bottle and extend therethrough. In this regard, the chemical container 215a may be in an inverted position to assist the flow of liquid medicine out of the bottle through the bottle connector 216 and outward.

[0098] Similarly, each of the first half 252a and the second half 252b may form a small drug container volume 256 within the disposable housing 212, which is specifically formed within the bridge member 261 and restricts movement by abutting against the outer periphery of the drug container 215b held within the small drug container volume 256. For this purpose, the first half 252a and the second half 252 are joined to define a small drug container volume 256, which includes an upper circular recess 274 that receives the circular bottom 276 of the drug container 215b (extending away from the lower arm 260), and a lower circular recess 278 that surrounds a port 280 (e.g., the cylindrical neck and cap of an IV bottle) that receives the circular uppermost portion 282 of the drug container 215b (extending away from the upper arm 258). The port 280 includes an opening that allows the bottle connector 216 to be connected to the neck of the bottle and extend therethrough. In this regard, the drug container 215b may be in an inverted orientation to assist in allowing the liquid drug to flow outward from the bottle through the bottle connector 216.

[0099] During manufacture, the drug container 215 may be filled by a pharmacist and installed within the disposable housing 212, which is done by installing the drug containers 215a and 215b into the large drug container volume 255 and the small drug container volume 256, respectively, and joining the first half 252a and the second half 252b. The disposable housing 212 is said to be capable of having either or both of the drug containers 215a and 215b installed such that the intended drug therapy can be delivered. For example, the drug therapy may require delivery from the drug containers 215a and 215b to be done separately, or simultaneously, or in sequence.

[0100] Patient 219 may well receive from the pharmacist a pre-filled drug container 215 pre-installed within a disposable housing 212, and as described above, the patient himself / herself in a home environment may attach a bottle connector 216 to the pre-filled drug container 215 and attach an upper electronic circuit unit 218 to an IV tube cartridge 220.

[0101] Referring also to FIG. 11, the bottle connector 216 may be connected to the drug container 215 to send liquid from the drug container 215 to the IV tube 214 as a fluid. The bottle connector 216 may be a cylindrical cap, enclosing a central hollow needle 92 extending along a needle axis 90, and is placed over and attached to the cap of the drug container 215. For example, it is provided with three axial slots 93 extending along the needle axis 90, and an upper portion 95 is divided into cantilever portions 96a, 96b, 96c. These cantilever portions are flexible both outwardly and inwardly toward the needle axis 90 at their upper rims 97. To provide further flexibility, a further axial slot 98 extending parallel to the needle axis 90 may be formed within the upper portion 95 below the upper rim 97. The cantilever portions 96a, 96b, 96c spread over and fit over the cap of the drug container, and further, the seal of the cap of the drug container 215 is pierced by the hollow needle 92, and the hollow needle 92 extends through the seal to enable the liquid drug to be drawn out from the internal space of the drug container 215. The bottle connector 216 may be vented for removal of air bubbles. The bottom portion 99 of the bottle connector 216 supports a tube connector 94 such that no-leak communication between the hollow needle 92 and the bottle connector 216 can be achieved as the fluid within the drug container 215 flows through the hollow needle 92 passing through the bottle connector 216.

[0102] The bottle connector 216 may further be connected to a right-angle luer connector 423, which comprises a luer lock 424 on an upper portion 426 that is attachable to the tube connector 94 of the bottle connector 216, and is joined to a tube connector 428 by a right-angle joint 427 joined to the upper portion 426. The tube connector 428 allows a flow through the right-angle luer connector 423 to the IV tube 214 by extending perpendicular to the needle axis 90. By connecting the tube connector 428 to the IV tube 214, the IV tube 214 can extend perpendicular to the needle axis 90, thereby minimizing the twisting of the IV tube 214 when the disposable housing 212 is held within the pouch 224 or when placed on a flat surface, thereby minimizing unwanted blockages.

[0103] The bottle connector 216 and the right-angle luer connector 423 may be attached to either one of the drug containers 215a and 215b, or two bottle connectors 216 and right-angle luer connectors 423 may be attached to both of the drug containers 215a and 215b, and separate IV tubes 214 may be joined into one IV tube 214 by a Y-connector.

[0104] Referring to FIG. 10, the IV tube 214 is further guided by an IV tube cartridge 220, which is coupled to a disposable housing 212 (e.g., attached to the outer surface of a bridge member 261). By the guide, the IV tube 214 may be constrained to the disposable housing 212 between the bottle connector 216 and the IV tube cartridge 220. The IV tube cartridge 220 comprises a shallow tray that stands upright and has end walls 300 and 302 that face each other in the longitudinal direction of the periphery, and these walls separate side walls 304 and 306 that stand upright opposite each other and extend in the longitudinal direction of the periphery.

[0105] The bottom wall 310 of the upper electronic circuit portion 218 may hold the peristaltic plunger element 244 aligned with the IV tube 214 of the IV tube cartridge 220 and the operators of the pressure sensors 246 and 248 extending downward. The IV tube 214 is held by the guide 301 of the IV tube cartridge 220, and the guide 301 forms a notch that holds the IV tube 214 longitudinally alongside the IV tube 214 within the tray. The end walls 300 and 302 of the lower clamp portion may further include notches that receive the retaining bushings 312a and 312b formed within the IV tube 214 to prevent the IV tube 214 from moving longitudinally along the longitudinal axis 222 relative to the IV tube cartridge 220. The IV tube 214 may also pass through the spring-biased clamp element 313, and the clamp element 313 automatically clamps the IV tube 214 when the IV tube cartridge 220 is separated from the upper electronic circuit portion 218.

[0106] The rear edge 315 of the bottom wall 310 of the upper electronic circuit portion 218 is spaced along the rear side wall 306 and extends outward of the tray away from the longitudinally extending side walls 304 and 306, and may support a hinge pin 314 spaced below the bottom wall 310 that receives the downwardly extending open hinge collar 316 of the IV tube cartridge 220 and extends generally parallel to the longitudinal axis 222. The open hinge collar 316 may be attached to the hinge pin 314 and hinge about the hinge pin 314.

[0107] The front edge 318 of the bottom wall 310 of the upper electronic circuit portion 218 may support a downwardly extending hook 320 that is actuated by a release button or release lever 232. The IV tube cartridge 220 is attached by the interconnection of the open hinge collar 316 and the hinge pin 314. When the bottom wall 310 of the upper electronic circuit portion 218 pivots downwardly toward the IV tube cartridge 220, the hook 320 may pass through a corresponding longitudinally extending tab 322 on the front side wall 304 of the IV tube cartridge 220 and be attached to the tab 322, thereby holding the upper electronic circuit portion 218 and the IV tube cartridge 220 together with the IV tube 214 in proper alignment therebetween.

[0108] The IV tube 214 may include an IV tube connector 217 that may communicate with a typical IV tube 213 that communicates with the patient 219 through a needle or port or the like, or alternatively may communicate with a syringe 329 for filling the syringe 329 with a liquid drug to be delivered to the patient 219 later. The IV tube 214 may be flexible and compliant to facilitate peristaltic pumping (e.g., may be made of a soft silicone material or a PVC peristaltic material), or may be a combination of a rigid vinyl material and a soft center material in which the flexible center material is disposed only within the range of the peristaltic plunger element 244, and thus may be made of a different material than a conventional IV tube 213.

[0109] Various drug delivery protocols may be supported by the control electronic circuit, and the present invention contemplates that the ambulatory pump 210 allows the patient 219 to be comfortably worn for hours or days in accordance with the drug delivery protocol. In some embodiments, a single drug bolus may be delivered, or drugs may be delivered periodically over a long period of time.

[0110] After drug delivery, by pressing or rotating the release button or release lever 232, the hook 320 can be released from the tab 322 to enable the release of the upper electronic circuit unit 218, and the upper electronic circuit unit 218 may be reused together with the new disposable housing 212 and the pre-filled drug container 215.

[0111] Accordingly, the present invention provides a pre-loaded disposable housing 212 that holds a pre-filled drug container 215 from a pharmacist, and further enables a patient 219 to deliver drugs at home by connecting an IV tube connector 217 to the pre-filled drug container 215 and the upper electronic circuit unit 218 of the ambulatory pump 210.

[0112] The ambulatory pump assembly of the present invention is not limited to being used for intravenous infusion therapy, and is also said to be used for subcutaneous infusion, arterial infusion, and epidural infusion for a wide range of medical applications (for example, administration of chemotherapy, pain management, total parenteral nutrition, antiemesis, antibiotics, etc.).

[0113] Some components of the wearable pump assembly 10 suitable for use with the present invention are generally described in U.S. Patent Application No. 17 / 520,182, filed on November 5, 2021, entitled "Clip-On Flow Control for IV Lines", U.S. Patent No. 10,869,963, filed on August 28, 2014, entitled "Low-cost ambulatory medical pump", and U.S. Patent No. 11,712,512, filed on May 20, 2020, entitled "Ambulatory medical pump cartridge locking system", each of which is incorporated herein by reference.

[0114] In this specification, certain terms are used for reference only and are not, therefore, intended to be limiting. For example, terms such as "upper", "lower", "above", and "below" refer to directions in the drawings being referred to. Terms such as "front", "back", "rear", "bottom", and "side" indicate the orientation of respective parts of a component within a consistent but arbitrary reference system, and these will become clear by referring to the text describing the component in question and the associated drawings. Such terms may include the specifically mentioned words, their derivatives, and synonyms. Similarly, terms referring to structure such as "first", "second", and other such numerical terms do not mean a particular arrangement or order unless specifically indicated by the context.

[0115] When introducing elements or features of the present disclosure and exemplary embodiments, the articles "a", "an", "the", and "said" shall be taken to mean that there is one or more of such elements or features. The terms "comprising", "including", and "having" are to be construed as inclusive and mean that there may be additional elements or features other than the specifically recited elements or features. Further, of course, the method steps, processes, and operations described herein are not to be construed as necessarily being carried out in the particular order described or illustrated unless specifically specified as the order of performance. Again, of course, additional or alternative steps may be used.

[0116] References to "a microprocessor" and "a processor," or "the microprocessor" and "the processor," may be understood to include one or more microprocessors that are communicable in the form of stand-alone and / or distributed environments and, thus, may be configured to communicate with other processors by wired or wireless communication, and such one or more processors may be configured to operate in one or more processor-controlled devices that may be the same device or different devices. Further, references to memory may, unless otherwise specified, be internal to the processor-controlled device, external to the processor-controlled device, or accessible via a wired or wireless network and may include one or more memory elements and / or memory components that are processor-readable and accessible from the processor.

[0117] It is specifically intended that the present invention not be limited to the embodiments and examples contained herein, and the claims are to be understood to include modifications of those embodiments that include portions of the embodiments and combinations of elements of separate embodiments, and are to be included within the scope of the following claims. All publications described herein, including patent and non-patent publications, are hereby incorporated by reference in their entirety.

[0118] Applicants note that, for the purpose of assisting the Patent Office and all readers of all patents issued on this application in construing the claims appended hereto, none of the appended claims or claim elements are intended to invoke 35 U.S.C. § 112(f) unless the phrase "means for" or "step for" is expressly used in a particular claim.

Claims

1. a housing configured to selectively support a vial containing a medication to be delivered to a patient; a patient support member for removably mounting the housing to the patient; a bottle connector mounted within the housing, a hollow needle for piercing a seal on the vial when the vial is inserted into the housing and for receiving the medication from the vial; a connector in fluid communication with the hollow needle for receiving the medication from the vial; The bottle connector comprising: a flexible IV tube having a first end connected to the connector, a second end connected to another connector, and a central portion extending between the first end and the second end; a peristaltic pump including a plurality of plunger elements selectively engaging the central portion of the flexible IV tubing, the plunger elements selectively compressing and releasing the central portion of the flexible IV tubing to withdraw the medication from the vial; 16. A wearable pump infusion assembly comprising:

2. The bottle connector further comprises: an opening at least partially defining a fluid communication path between an ambient environment outside the vial and an interior space of the vial; a hydrophobic filter in the fluid communication path that allows air to pass from the ambient environment into the vial and prevents the medication from exiting the opening; 10. The wearable pump infusion assembly of claim 1, comprising:

3. 2. The wearable pump infusion assembly of claim 1, further comprising a locking assembly that engages with the neck of the vial, pulls the vial over the hollow needle of the bottle connector, and secures the vial within the bottle connector.

4. 4. The wearable pump infusion assembly of claim 3, wherein the locking assembly includes a first hinged latch on a first side of the housing and a second hinged latch on a second side of the housing, the second side being opposite the first side.

5. The housing further comprises: A first portion, A first interlocking element; at least one vial retaining member for receiving the vial; the bottle connector mounted within the housing; the flexible IV tubing mounted in the bottle connector; the first portion comprising: A second portion, a second interlocking element, the second interlocking element being complementary to the first interlocking element, the first and second interlocking elements holding the first and second portions of the housing together; and an electronics housing, the electronics housing having a controller for the wearable pump infusion assembly housed within the electronics housing; the second portion comprising:

10. The wearable pump infusion assembly of claim 1, comprising:

6. The wearable pump infusion assembly of claim 5 , wherein the second portion of the housing is reusable with multiple first portions of the housing.

7. The electronic circuit housing further comprises: at least one selection device for adjusting a desired flow rate of the drug from the vial; at least one flow sensor for detecting an actual flow rate of the medication from the vial, the controller being operative to receive a feedback signal from the at least one flow sensor and to achieve the desired flow rate by adjusting a rate at which the plurality of plunger elements engage the central portion of the flexible IV tubing in response to the feedback signal; 6. The wearable pump infusion assembly of claim 5, comprising:

8. The wearable pump infusion assembly of claim 7 , wherein the at least one selection device includes at least one selection button actuated by the patient to adjust the desired flow rate.

9. The wearable pump infusion assembly of claim 7 , wherein the at least one selection device further comprises at least one selection switch within the electronic circuit housing for adjusting the desired flow rate.

10. The wearable pump of claim 1 , wherein the patient support member is selected from a neck strap, a belt, and a clip.

11. 1. A method of delivering a drug to a patient, comprising: Inserting a vial containing the medication to be delivered to the patient into a housing having a bottle connector mounted within the housing, the bottle connector comprising: a hollow needle for piercing a seal on the vial when the vial is inserted into the housing and for receiving the medication from the vial; a connector in fluid communication with the hollow needle for receiving the medication from the vial; the inserting step including: placing a patient support member on the patient to support the housing on the patient; pressing a button on a user interface to initiate treatment of the patient; delivering the medication to the patient via a peristaltic pump and flexible IV tubing; the flexible IV tube has a first end connected to the connector, a second end connected to another connector, and a central portion extending between the first end and the second end; the peristaltic pump includes a plurality of plunger elements selectively engaging the central portion of the flexible IV tubing, the plunger elements compressing and releasing the central portion of the flexible IV tubing to draw the medication from the vial; said delivering step; The method includes:

12. and drawing air from an ambient environment outside the vial into an interior space of the vial while delivering the medication to the patient, the bottle connector further comprising: an opening at least partially defining a fluid communication path between the ambient environment and the interior space of the vial; a hydrophobic filter in the fluid communication path that allows the air to pass from the ambient environment into the vial and prevents the medication from exiting the opening; The method of claim 11 , comprising:

13. pulling the vial onto the hollow needle of the bottle connector with a locking assembly; securing the vial within the bottle connector with the locking assembly; The method of claim 11 further comprising:

14. 14. The method of claim 13, wherein the locking assembly includes a first hinged latch on a first side of the housing and a second hinged latch on a second side of the housing, the second side opposite the first side.

15. further comprising connecting a first portion of the housing to a second portion of the housing; The first portion is A first interlocking element; at least one vial retaining member for receiving the vial; the bottle connector mounted within the housing; the flexible IV tubing mounted in the bottle connector; Including, The second portion is a second interlocking element, the second interlocking element being complementary to the first interlocking element, the first and second interlocking elements connecting the first and second portions of the housing together; and an electronics housing, the electronics housing having a controller for the wearable pump infusion assembly housed within the electronics housing; Including, The method of claim 11.

16. The method of claim 15 , wherein the second portion of the housing is reusable along with a plurality of first portions of the housing.

17. adjusting a desired flow rate of the drug from the vial with at least one selection device within the electronic circuit housing; measuring an actual flow rate of the drug from the vial with at least one flow sensor; achieving the desired flow rate by adjusting a speed at which the plurality of plunger elements engage the central portion of the flexible IV tubing, wherein the controller is operative to receive a feedback signal from the at least one flow sensor and adjust the speed in response to the feedback signal; The method of claim 15 further comprising:

18. 20. The method of claim 17, further comprising at least one selection button on the electronics housing that is actuated by the patient to adjust the desired flow rate.

19. 20. The method of claim 17, wherein at least one selection switch is located within the electronics housing for adjusting the desired flow rate.

20. The method of claim 11 , wherein the patient support member is selected from a neck strap, a belt, and a clip.

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