HK1179190B - Modular portable infusion pump - Google Patents

Description

Portable modular infusion pump

This application is a divisional application entitled "modular portable infusion pump" filed on 5.11.2006, application number 200680048301.5.

RELATED APPLICATIONS

This application claims priority and benefit to israel patent application No. 171813, filed on 7/11/2005, the entire disclosure of which is incorporated herein by reference.

Technical Field

Embodiments of the present invention generally relate to methods, systems and various devices for continuous medical infusion of fluids, and more particularly to a system having a portable infusion device (preferably miniature) that is directly attached to the skin of a patient, and to related methods and devices for accurately dispensing a liquid from a device into a patient. Some embodiments of the present invention relate to the connection (e.g., planar connection) of two or more separate portions, such as a disposable portion and a reusable portion, preferably forming a flexible, pliable and thin skin compliance device (e.g., patch).

Background

Medical treatment of several diseases requires continuous infusion of drugs into various body tissues by, for example, subcutaneous and intravenous injection. Diabetics need different amounts of insulin administered throughout the day to control blood glucose levels. In recent years, ambulatory, portable insulin infusion pumps have become an advanced alternative to multiple daily injections of insulin. These pumps provide insulin at a sustained basal rate and bolus volumes (bolus volumes), which have been developed to free patients from repeated self-administered injections and enable them to maintain near normal daily life. Depending on the individual prescription, basal and bolus volumes must be provided in precise doses, since an excess of insulin is fatal. Therefore, the insulin injection pump must very reliably prevent any inadvertent supply of excess insulin.

There are several ambulatory insulin infusion devices currently on the market. Typically, these devices have two parts: a reusable portion containing the dispenser, controller and electronics, and a disposable portion containing the reservoir, a needle assembly with cannula and trocar, and a catheter. Inserting needles of various lengths and insertion angles requires a great deal of skill and practice, depending on the needs of the injection site on the body. Generally, the patient fills the reservoir, connects the needle and delivery tube to the outlet of the reservoir, and then inserts the reservoir into the pump housing. After purging the reservoir, tubing and needle of air, the patient inserts the needle assembly (trocar and cannula) into the body at the selected site and withdraws the trocar. To avoid irritation and infection, the subcutaneous cannula must be replaced and discarded after two to three days, along with the empty reservoir.

First generation disposable syringe-type reservoirs and examples of various tubing are described in U.S. patent No. 3631847 filed by Hobbs in 1972, and in U.S. patent No. 3771694 filed by Kaminski in 1973, and in U.S. patent No. 4657486 filed by Stempfle later, and in U.S. patent No. 4544369 filed by Skakoon. The drive mechanism of these devices is a screw drive plunger which is used to control the programmable movement of the syringe piston. Other dispensing mechanisms including peristaltic volumetric pumps have been described in applications such as U.S. patent No. 4197852 to willied Schal et al, 1980, and U.S. Pat. No. 4498843 to Schneider later, and U.S. patent No. 4715786 to Wolff.

These devices show significant improvements over multiple daily injections, but all of them suffer from several drawbacks. The main drawback is the large volume and weight of the device caused by the spatial structure of the syringe and the piston and the relatively large drive mechanism. The relatively bulky device must be carried in a patient's pocket or attached to a belt. Therefore, in order to be able to insert the needle into a remote part of the body, the catheter is long, typically longer than 40 cm. These bulky devices with long tubing, which are less convenient, are rejected by most diabetic insulin users because they interfere with normal activities, such as sleeping and swimming, for example. Furthermore, the impression effect on the body of the teenager is unacceptable.

In addition, catheters exclude alternative distal insertion sites such as the buttocks and extremities. To avoid piping limitations, a second generation of such devices has been devised. These devices include a housing having a bottom surface adapted to contact the skin of a patient, a reservoir disposed within the housing, and an injection needle adapted to communicate with the reservoir.

Such examples are described in U.S. patent No. 4498843 to Schneider, U.S. patent No. 5957895 to Sage, U.S. patent No. 6589229 to Connelly, and U.S. patent nos. 6740059 and 6749587 to Flaherty, none of which are currently commercially available. The second generation devices mentioned above have several limitations. They are bulky because the reusable dispensing part, including the drive mechanism, is fitted on top of the disposable needle/reservoir part. This "sandwich-shaped" design and their stacking into at least two layers results in a relatively thick device with a thickness between 15 and 20 mm. Furthermore, once the needle emerges from the bottom of the device (either manually or automatically) during insertion, the needle is inserted generally perpendicular to the skin (e.g., at a predetermined angle), which is inconvenient for most patients and requires some skill to accomplish. Such devices are discarded by patients who want to view the puncture site and propose a needle insertion angle of less than 30 °.

A second generation of devices with a peristaltic dispenser of the capacity, such as the device disclosed by Flaherty in U.S. patent No. 6749587, is equipped with a drive mechanism and engine contained within a reusable portion that sits on top of a pump wheel contained within a disposable portion. This configuration exhibits major limitations associated with inefficient energy utilization and constant, long-term pressure of the pump wheel(s) applied to the transfer tube throughout the shelf life of the dispenser. Due to the long-term pressure, the operation of the dispenser may be accompanied by inaccuracies due to creep of the plastic material from which the transfer tube is made. Another drawback of the above-mentioned structure is related to the fact that it is only possible to purge the air after assembling all the components of the dispenser and to require the operation of the engine.

Other disadvantages of second generation devices include leaky connections between the reusable and disposable parts, and not being waterproof. Finally, it is widely believed that the main limitation of the first and second generation pumps is their extremely high purchase price, requiring $4000 to $6000, and accumulating approximately $250 in maintenance costs per year.

Thus, there is a need for a miniature portable programmable liquid dispenser which has an insertion needle that does not require direct connection to a connecting tube, which can be directly attached to the skin of a patient at any desired location on the patient's body, and which can be remotely controlled. Preferably, the disposable part of the device should contain a reservoir that can be filled and purged manually. After the reusable and disposable portions are connected, the thickness of the unified device should be small (e.g., less than five (5) mm). Furthermore, the reusable part should contain a high precision peristaltic pump for dispensing the liquid dose very precisely.

Disclosure of Invention

Embodiments of the present invention address the above-mentioned concerns and propose methods, systems and devices for continuous medical infusion of beneficial and therapeutic liquids into the body of a patient, preferably in a programmable mode with high precision dosing provided by a skin-adherent and preferably compliant flexible device (e.g., patch).

It is an aim of some embodiments of the present invention to provide a method of continuous medical infusion that injects a liquid into a patient's body at a controlled rate. Such a method may include one or more of the following steps:

providing a first separate reusable unit, preferably comprising:

a controller for managing the operation of the operation,

a transceiver for use in communication with the mobile device,

an engine for generating an action of the fluid transfer system, an

A primary portion (preferably a primary portion) of a fluid transfer system that is capable of liquid transfer when the primary portion is operatively coupled to a secondary portion;

providing a second separate depletable unit, preferably comprising:

a secondary portion of a fluid transfer system for coupling to the primary portion,

a reservoir of the liquid to be infused,

optionally providing a well chamber

A conduit capable of communicating fluid from the reservoir to the body of the patient, an

At least one battery for powering the first unit when the first unit is operatively coupled to the second unit;

providing a third separation unit, preferably comprising:

a sleeve, and

a trocar fitted to the cannula for inserting the cannula into the skin and body; and

providing a fourth separate remote control unit, preferably comprising:

a transceiver for communicating with a first unit,

at least one memory for storing at least one of one or more computer programs, data, and instructions,

a command and control module coupled to the memory and to the transceiver for receiving, executing and issuing data and instructions, an

An I/O user interface for data communication with a user and for sending instructions from the user to the controller and transceiver.

Upon appropriate instruction from the fourth unit, the engine is powered to generate action of the fluid transfer system when (preferably) all three of the first, second and third units are coupled together in a co-operative manner and disposed on the skin of the patient, and to transfer liquid from the reservoir into the body when the cannula is inserted into the body of the patient under the control of the controller and transceiver.

It is a further object of some embodiments of the present invention to provide a method for continuous medical infusion in which a primary portion of a fluid delivery system is disposed within a first unit and a secondary portion of the fluid delivery system is disposed within a second unit, and the first unit and the second unit are coupled in a co-operative manner such that the fluid delivery system is operable to eject fluid.

It is a further object of the present invention to provide a method for continuous medical infusion wherein a first unit of a fluid dispenser and a second unit of the fluid dispenser are removably coupled together and each of the first and second units can be configured as a flexible, skin-compliant cuff and at least the second unit is removably attached to the skin. Each envelope may also be transparent.

It is a further object of some embodiments of the present invention to provide a method for continuous medical infusion in which each of the first, second and third units may be present in different types depending on the desired treatment, yet still be able to be connected together to form a dispensing device (i.e., each type of each unit may be used interchangeably with many types of other units).

It is a further object of some embodiments of the present invention to provide a method for continuous medical infusion in which a primary portion of a fluid transfer system applies pressure to a tubing so as to cause fluid to flow therethrough only when the primary portion is operatively coupled to a secondary portion.

It is a further object of some embodiments of the present invention to provide a method for continuous medical infusion in which the reservoir may be manually filled and air may be manually purged out of at least one of the reservoir, tubing and well.

It is a further object of some embodiments of the present invention to provide a method for continuous medical infusion wherein the cannula can be inserted at any desired angle ranging from zero degrees to 90 degrees.

It is a further object of the present invention to provide a method for continuous medical infusion wherein at least one sensor is disposed on either or both of the first unit of the fluid dispenser and the second unit of the fluid dispenser to provide a feedback signal to the controller and the transceiver.

It is a further object of some embodiments of the present invention to provide a continuous medical infusion system that injects a liquid into a patient's body at a controlled rate. Such systems may include one or more, and preferably most or all, of the following:

a first separate reusable unit, preferably comprising:

a controller for managing the operation of the operation,

a transceiver for use in communication with the mobile device,

an engine for generating an action of the fluid transfer system, an

A primary (e.g., main) portion of a fluid transfer system that can be liquid-transferring when coupled to a secondary portion;

a second separate depletable unit, preferably comprising:

a secondary portion of a fluid transfer system for coupling to the primary portion,

a reservoir of the liquid to be infused,

optionally a well (well)

A conduit capable of communicating fluid from the reservoir to the body of the patient, an

At least one battery for powering the first unit when the first unit is operatively coupled to the second unit;

a third unit, preferably comprising:

a sleeve, and

a trocar adapted to the cannula for inserting the cannula into the skin and body; and

a fourth separate remote control unit, preferably comprising:

a transceiver for communicating with the controller and the transceiver,

at least one memory for storing at least one of one or more computer programs, data, and instructions,

a command and control module coupled to the memory and to the transceiver for receiving, executing and issuing data and instructions, an

An I/O user interface for data communication with a user and for sending instructions from the user to the controller and transceiver.

Upon appropriate instruction from the fourth unit, the engine is powered to generate action of the fluid transfer system when (preferably) all three of the first, second and third units are coupled together, preferably in a co-operative manner, and disposed on the skin of the patient, and liquid is delivered from the reservoir into the body via the tubing and cannula under the control of the controller and transceiver when the cannula is inserted into the body of the patient.

It is a further object of some embodiments of the present invention to provide a continuous medical infusion system that utilizes the steps of the above method.

It is a further object of the present invention to provide one or more continuous medical infusion devices for injecting a liquid at a controlled rate into the body of a patient, the device preferably comprising:

a first separation reusable apparatus, preferably comprising:

a controller for managing the operation of the operation,

a transceiver for use in communication with the mobile device,

an engine for generating an action of the fluid transfer system, an

A primary (e.g., primary) portion of a fluid transfer system, the fluid transfer system being operable to transfer a liquid when coupled to a secondary portion;

a second separate depletable device, preferably comprising:

a secondary portion of a fluid delivery system for coupling to the primary portion,

a reservoir of the liquid to be infused,

optionally a well chamber

A conduit capable of communicating fluid from the reservoir to the body of the patient, an

At least one battery for powering the first device when the first device is operatively coupled to the second device;

a third apparatus, preferably comprising:

a cannula for insertion into the body of a patient, an

A trocar adapted to the cannula for inserting the cannula into the skin and body; and

a fourth separate remote control device, preferably comprising:

a transceiver for communicating with the controller and the transceiver,

at least one memory for storing at least one of one or more computer programs, data, and instructions,

a command and control module coupled to the memory and to the transceiver for receiving, executing and issuing data and instructions, an

An I/O user interface for data communication with a user and for sending instructions from the user to the controller and transceiver.

Upon appropriate instruction from the fourth device, the engine is powered to generate action of the fluid delivery system when (preferably) all three of the first, second and third devices are coupled together and disposed on the skin, preferably in a co-operative manner, and to deliver liquid from the reservoir into the body via the tubing and cannula, under the control of the controller and transceiver, when the cannula is inserted into the body of the patient.

These and other embodiments, advantages and objects of the present invention will become more apparent in view of the following description and the accompanying drawings, a brief description of which is given below

Drawings

FIG. 1 illustrates a block diagram of a fluid transfer system according to some embodiments of the present invention;

FIG. 2 is a schematic view of a second unit coupling an edge portion of a first unit to a liquid dispensing apparatus, according to some embodiments of the invention;

FIG. 3 illustrates a first portion of a fluid transfer system according to some embodiments of the present invention;

FIG. 4 illustrates a partial cross-sectional view of portions of a fluid transfer system according to some embodiments of the present invention;

FIG. 5 illustrates a transfer system for transferring rotational motion in a fluid transfer system according to some embodiments of the present invention;

FIG. 6 illustrates a launching system for transferring rotational motion in a fluid transfer system according to some embodiments of the invention;

FIG. 7 illustrates a linear actuator used in conjunction with a fluid transfer system according to some embodiments of the present invention;

FIG. 8 illustrates a piezoelectric actuator used in conjunction with a fluid delivery system according to some embodiments of the present invention;

FIG. 9 illustrates a reusable sensor for use with a fluid transfer system according to some embodiments of the present invention;

figure 10 illustrates a partial cross-sectional view of depletable unit II according to some embodiments of the invention;

figure 11 illustrates a partial cross-sectional view of a depletable unit II having an injection unit III partially snapped therein according to some embodiments of the invention;

FIG. 12 shows another partial cross-sectional view of the depletable unit II and the injection unit III shown in FIG. 11;

figure 13 illustrates a partial cross-sectional view of a depletable unit II according to some embodiments of the invention;

figure 14 illustrates a partial cross-sectional view of the depletable unit II of figure 13 with an injection unit III partially snapped therein according to some embodiments of the invention;

figure 15 shows the trocar of injection unit III after withdrawal of the depletable unit II of figure 13, in accordance with some embodiments of the present invention;

FIG. 16 illustrates a depletable unit II and an injection unit III with a vent tube according to some embodiments of the invention;

figure 17 illustrates depletable unit II and injection unit III according to some embodiments of the invention;

figure 18 illustrates a partial cross-sectional view of depletable unit II according to some embodiments of the invention;

figure 19 illustrates a partial cross-sectional view of depletable unit II according to some embodiments of the invention;

FIG. 20 illustrates a block diagram of a fluid transfer system according to some embodiments of the present invention;

FIG. 21 is a schematic view of a pressure sensor apparatus according to some embodiments of the invention;

FIG. 22 is a schematic diagram of the integration of the transmitting and receiving contacts into the pressure sensing device structure according to some embodiments of the invention;

FIG. 23 is a graphical representation of a pulse sequence generated by a piezoelectric pressure sensor in accordance with some embodiments of the invention;

FIG. 24 is a block diagram of electronic circuitry for a reusable unit according to some embodiments of the present invention;

FIG. 25 is a schematic diagram of a reusable unit I and a depletable unit II, separated, according to some embodiments of the invention;

FIG. 26 is a schematic diagram of a connected reusable unit I and depletable unit II, according to some embodiments of the present invention;

FIG. 27 is a side view of an assembled reusable unit I and depletable unit II positioned adjacent the skin of a patient according to some embodiments of the present invention;

FIG. 28 is a schematic diagram of a reusable unit I and a depletable unit II with a symbolically depicted injection unit III, according to some embodiments of the invention;

FIG. 29 is a schematic view of the connected reusable unit I and depletable unit II of FIG. 28;

fig. 30 is a block diagram of a remote control unit IV according to some embodiments of the present invention.

Detailed Description

Fig. 1 is a block diagram of an exemplary system 1000 that enables continuous controlled injection (preferably at a predetermined rate) of a liquid into the skin or subcutaneously into the body of a patient. The term "body B" is to be considered as meaning: enters the body B subcutaneously and may also be referred to as intravenous injection.

The system 1000 includes a reusable unit I, a depletable unit II, an injection unit III, and a remote control unit IV (unit IV), which are preferably separate units. Unit I and unit IV are each reusable, while depletable unit II and injection unit III are preferably both disposable, and both together form a disposable portion or unit that is disposable after a single use. Together, cells I, II and III form a fluid dispensing apparatus.

The following description of the operation of system 1000 is for example only, and those skilled in the art will appreciate that other methods of operation are within the scope of this and related embodiments of the present invention. Thus, user U selects reusable unit I and depletable unit II and preferably programs system 1000 using remote control unit IV. The depletable unit II can then be filled with the desired liquid and coupled to the reusable unit I after purging the air. Injection unit III is selected and preferably introduced into depletable unit II. Optionally, the injection unit III may be integrally formed with the depletable unit II. After purging the air, the units I, II and III are applied to the skin S, and preferably adhere to the skin S, while the needles penetrate the skin S and enter the body B. Units I and II are flexible envelopes, which may be transparent, and at least unit II is removably attached to the skin S.

The remote control unit IV can then be operated to program the fluid dispensing device to command liquid flow from the depletable unit II, preferably through the skin S (i.e. subcutaneously), into the body B. User U is either an operator who applies system 1000 to the body or a self-administered patient.

As shown in fig. 1, in general, unit I may include one or more (and preferably all) of the following components: a control, command and transceiver module 101 (or controller or transceiver 101) for controlling and communicating in fluid injection management and for bi-directional communication with a remote control unit IV. Also included in unit I is an engine 103 for imparting motion to a fluid transfer element 105 (or simply transfer element 105) of a fluid transfer system. The fluid transfer system preferably comprises components belonging to both unit I and unit II. Specifically, the fluid transfer system may include an engine 103, a fluid transfer element 105, a flexible conduit 205, and a liner 207, the latter two elements preferably being included in unit II. In order for the engine 103 and transmission element 105 to become operational, unit I is preferably first coupled to depletable unit II to obtain electrical energy therefrom, and because the transmission element 105 operates in conjunction with the tubing 205 and liner 207 contained within unit II.

The transmission element may have a primary, main part located in the first unit I and a secondary part located in the second unit II. When the first unit I and the second unit II are coupled in a jointly operable manner, fluid transfer out of the second unit II can take place under the condition that the engine 103 is powered.

In general, the depletable unit II preferably includes one or more batteries 201 for powering the reusable unit I, a reservoir 203, and a line 205, the reservoir 203 being either pre-filled with a dispensed liquid or filled with a liquid prior to use, the line 205 being coupled to the reservoir for delivering the liquid to the well 206. The liquid (which is not shown in the figures) can be injected only after the injection unit III is coupled to provide fluid communication with the depletable unit II and the injection unit III is inserted into the skin S or body B.

The injection unit III essentially comprises a needle 301, preferably a trocar 303, which is preferably assembled with other elements. For liquid injection, the injection unit III is inserted into the depletable unit II at the well 206. Well 206 is coupled in fluid communication with tubing 205. Needle 301 is inserted into well 206 and through skin S into body B. The trocar 303 may then be withdrawn and the fluid injected and administered and dispensed from the fluid delivery system at a predetermined rate. The liquid may be a beneficial fluid or therapeutic agent.

Each of the three units I, II and III can be of various types, where each type of the same unit (i.e., I, II or III) can be interchanged or substituted with other types. Different types of cells I, II and III may be configured to be removably coupled for operation.

For example, different types of reusable units I may include a controller and transceiver module 101 having a selected level of complexity, and optionally I/O devices (pads) and/or connections, safety sensors, and may include other options. Likewise, different types of depletable units II may have reservoirs 203 of different sizes, batteries of different capacities, and contain alternative liquids. Similarly, the injection unit III may have a shorter, longer or different type of needle adapted to be inserted at an angle or perpendicular to the skin, as desired.

Regardless of their type, the various components of the reusable unit I and the depletable unit II are preferably arranged in a single layer (arranged and supported on the same plane), with their respective portions preferably connected and coupled. When assembled and attached to the skin S, placed side-by-side along their thickness dimension (i.e., arranged end-to-end), the two units I and II preferably cover an area of the measurement area that is no greater than about half (or less) of a plastic credit card, or typically about 65mm by about 25 mm. The unit III preferably does not increase the covered area.

Both the reusable unit I and the depletable unit II are preferably fully sealed and each may form a flexible enclosure that remains sealed even when in use. In one particular embodiment, one side or surface of the envelope of unit I and unit II may be configured for interfacing with the skin S, such as a skin compliance patch, up to about 4mm high (for example). In practice, the reusable unit I is detachably latched to the unit II and at least the unit II (and if desired the unit I) is detachably attached to the skin S.

The needles 301 may vary in length depending on the type. For example, the needle 301 may be customized to penetrate only 3mm subcutaneously, or 30mm deep. The height of the skin attachment unit preferably does not increase after removal of the trocar 303.

The mechanism of fluid transfer illustrates the operation of elements I, II and III in relation thereto. In principle, according to one embodiment of the invention, the fluid transfer system is a peristaltic volumetric pump-wherein the fluid transfer line 205 is squeezed in order to transfer fluid from the reservoir for injection into the body of the patient. The primary (main) part of the peristaltic volumetric pump, and the engine 103 driving the pump, may be included in unit I. However, tubing 205, backing 207, liquid within reservoir 203, and battery 201 of drive unit I may be included in depletable unit II. In some embodiments, the actual liquid injection is only possible when at least units I and II are coupled together for operation.

FIG. 2 is a schematic diagram illustrating an edge portion of unit I when connected to unit II, illustrating an exemplary fluid transfer system according to some embodiments of the present invention. A single toothed wheel with teeth 1053, or cogwheel 1051, or gear 1051, is suitably arranged to squeeze the outer wall of the flexible tubing 205, it being seen that the tubing 205 is coupled to the reservoir 203 and extends out of the reservoir 203. The tubing 205 is extruded between the teeth 1053 of the gear 1051 and the backing 207 positioned adjacent to and tangentially to the gear 1051. Optionally, the backing may comprise a backing sheet 207 that is flat or curved. Preferably, the backing 207 is loaded by a spring 2070 biased against a fixed base 2074.

When the engine 103 rotates the gear 1051 in a clockwise direction as viewed in FIG. 2, the amount 1055 of fluid trapped between two adjacent teeth 1053 of the gear 1051 is transferred along the line. The transfer of liquid takes place from the upstream suction end 31 adjacent the reservoir 203 to the outflow end 33 downstream of the transfer element 105, leading the liquid to the well 206 and finally to the needle in unit III. A flexible conduit 205 extends between the reservoir 203 and the well 206.

When unit I is not coupled to unit II (during periods of non-use), no pressure or force is applied to tubing 205, resulting in a longer shelf life for the tubing.

Various types of engines 103 may be used, some examples of which are described below. Regardless of the type, the engine 103 may operate continuously, or at appropriately selected intervals, depending on the rate of fluid to be dispensed.

When properly selected, the fluid delivery system comprising the gear 1051, backing 207, and teeth 1053 substantially ensures and preferably permanently prevents direct flow in one or both directions to the suction end 31 or the outflow end 33, thereby enhancing safety of use. Thus, such fluid transfer systems according to some embodiments of the present invention are capable of controlling the direction of fluid flow without the need for valves; as long as at least one tooth 1053 fully squeezes the tubing 205 and blocks the fluid passage, no valve is required. The use of the aforementioned displacement pump is independent of the back pressure, so that a drop in the back pressure does not occur.

In some embodiments of the invention, the dispenser is at 10 between about 0.2-1 per roller or tine 1053^-4cc, discrete, equal volumes between to provide infusion fluid. Therefore, the flow rate can be set in a minute amount and can be accurately controlled simply by adjusting the rotation speed of the wheel 1051. In other words, the flow rate can be measured simply by counting the rollers or teeth as they rotate through the conduit 205. In various drive wheel configurations, at least one roller or tooth 1053 preferably always forces against the conduit 205, which substantially eliminates (and preferably eliminates) a hydraulic "short circuit" (i.e., direct communication between the reservoir and the well 206).

A desired liquid flow rate can be obtained according to the number of teeth 1053 rotated per unit time. Assume that gear 1051 rotates compression line 205 at a rate of n teeth per minute and that the amount 1055 or base volume v of fluid trapped between two adjacent teeth 1053 of gear 1051 is_t mm³Then the pumping rate of the liquid flow can be calculated as follows:

flow rate n.v_t[mm³Per minute] （1）

Wherein "n" ranges from 0 to a maximum and v is defined according to the structure of the selected cogwheel 1051_t. This can be done by programming the controller and transceiver 101 to operate for a given v_tThe parameter n is appropriately controlled to achieve quantitative liquid transfer with high accuracy.

The reservoir 203 is preferably configured as a flexible container 203 or a resiliently collapsible and expandable bladder 203 (or other collapsible fluid retaining device). The reservoir 203 may include a self-sealing fill port 2031 to allow the user U to fill the reservoir with a syringe (not shown in the figures). To this end, the user U selects the desired liquid and fills it into the syringe. The self-sealing fill port 2031 of the reservoir 203 is then pierced using the needle of the syringe and the selected liquid is injected into the container 203, or bladder 203, which expands to a maximum volume during filling.

When the reservoir 203 is filled to capacity, liquid will continue to flow to also fill the line 205 and eventually out of the well 206. By virtue of this measure, the user U can manually purge air out of the unit II before using the device. After filling the reservoir 203, the syringe is withdrawn from the fill port 2031 and the fill port 2031 automatically seals the reservoir.

The reservoir 203 is preferably manufactured integrally with the tube 205 or sealingly connected thereto by means of a conventional connector (not shown in the figures). Optionally, the reservoir 203 may be provided for factory pre-filling.

The expansion of the bladder 203 may be limited by, for example, a hood or housing not shown in the figures, or may be able to expand freely until inhibited by the unit II or its shell. In some embodiments, when free, the bladder 203 may expand in all directions and penetrate into the various voids, even filling the gaps remaining between the components, maximizing the use of unused space.

In fig. 2, separation line SL represents the abutting edges of unit I and unit II, clearly showing that no fluid transfer will occur when units I and II are separated, as wheel 1051 will be away from conduit 205 and engine 103 will lose electrical power received from battery 201.

Each unit may include a specific type for a specific application/treatment. To this end, each type may be distinguished from the others, for example, by fluid content, a reservoir 203 of a selected size, and/or a battery of a given power.

Figure 3 shows another embodiment of a wheel 1051 having freely revolving rollers 1057 supported at the distal ends of all the tines 1053 to provide low rolling friction.

Fig. 4 depicts a partial cross-sectional view of yet another embodiment, wherein a roller 1057 is freely and rotationally supported between two discs 1059. The outer circumference of each disk 1059 may exceed the outer circumference of the rollers 1057 such that the diameter of the conduit 205 is partially or completely between the two disks 1059. The discs 1059 are adapted to engage other engagement drive means. It is sufficient to use only one disc 1059 with rollers 1057, if necessary. Other embodiments of the support disc are possible.

Fig. 5 shows the transfer of the rotational motion from the motor 103 via the automatic transmission wheel to the gear 1051 or to the meshing disc 1059. The engine 103, here the electric motor 103, drives a first spur gear 1061, the first spur gear 1061 engaging a second spur gear 1063 having a larger diameter than the gear 1061. And a third spur gear 1065 concentrically fixed to the second spur gear 1063 and having a smaller diameter than the second spur gear 1063, and a fourth spur gear 1067 having a larger meshing diameter than the third spur gear 1065, and a worm gear 1069 concentrically fixed to the fourth spur gear 1067. At the end of the reduction train, worm gear 1069 rotates gear 1051.

Fig. 6 is another embodiment of the gear train reduction mechanism. The motor 103 drives the worm gear 1071, the worm gear 1071 engages the spur gear 1073, and the spur gear 1073 is concentrically mounted with a spur gear 1075 having a smaller diameter. Final spur gear 1075 rotates gear 1051 or disc 1059. Other transmission arrangements are possible, such as by friction, gearing, and flexible shafts.

Fig. 7 presents a linear actuator 1081, such as a solenoid, and a reciprocating plunger 1083 having impact teeth 1053 to drive the wheel 1051 in a counterclockwise direction.

FIG. 8 shows a piezoelectric actuator 1091 with teeth 1053 on the periphery of a tangential bite wheel 1051 or plate 1059 to provide counterclockwise rotation. The power pulse causes piezoelectric actuator 1091 to provide a tangential impact to teeth 1053 and rotate wheel 1051.

Other transmission and reduction mechanisms are possible, which may utilize planetary gears, rolling and friction gears, rack and pinion mechanisms, and belts, either alone or in combination.

A simple reusable sensor may optionally be mounted on the unit I in order to report to the controller and transceiver 101 the correct rotation of the wheel 1051 inherent to the transmission element 105.

Fig. 7 schematically illustrates a reusable sensor 21 that may be used with embodiments of the present invention, arranged opposite a tooth 1053 in the plane of the wheel 1051. One or more wires 23 are connected between the sensor 21 and the controller and transceiver 101. The reusable sensor 21 is selected as an appropriate component of a type known in the art, such as a capacitive sensor, an inductive sensor, a magnetic sensor, a mechanical sensor, or an optical sensor, or a combination thereof. In one embodiment, the reusable sensor 21 is disposed on the opposite side of the tooth 1053, as shown in FIG. 9. To do so, the controller and transceiver 101 can compare the rate of rotation of the wheel 1051 under command with the output of the reusable sensor 21 and transmit a correction signal (if necessary) to the transmission element 105.

In fig. 1, the arrows coupled from the transmission element 105 to the controller and transceiver 101 represent feedback used in some embodiments to enable the controller to respond accordingly when needed. Thereby enhancing the reliability of the system 100.

In some embodiments, regardless of the type of engine 103 or fluid transfer element 105 used in the fluid transfer system, when unit II is coupled to unit I, the battery 201 within unit II is electrically connected to delivery contact 2209, which may be appropriately arranged to couple with receiving contact 107 disposed within unit I. In turn, the receiving contact 107 may connect the controller and transceiver 101 and to the engine 103, and the engine 103 may activate the fluid transport element 105. After use and exhaustion, unit II is discarded and replaced, while unit I can be reused.

Figure 10 is a partial cross-sectional view of a portion of the depletable unit II showing the cuff 2001, downstream end 2051 of flexible tube 205, coupled in fluid communication with the well 206, according to some embodiments. When the hole 206 is filled with liquid, the liquid may provide an injection through the injection unit III. The well 206 serves as a reservoir for the liquid and may be configured with a conduit inlet 2061, an inlet bore 2063, and an outlet bore 2065, with the downstream end 2051 of the conduit 205 attached to the conduit inlet 2061.

In fig. 10, the inlet aperture 2063 and the outlet aperture 2065 are preferably removably fully sealed by an inlet plug 2067 and an outlet plug 2069, respectively. A peel-off label or other sealing device may be provided in place of the inlet and outlet plugs 2067 and 2069.

The well chamber 206 may extend from the inlet aperture 2063 to the outlet aperture 2065, substantially directly through the entire height of unit II, and may also be perpendicular to the conduit 205. The outlet aperture 2065 may be flush with the proximal surface of the unit II to be attached to the skin S, and the inlet end 2063 may open onto the opposite surface of the unit II, which is the distal surface directed away from the skin. This placement of the well 206 is referred to as a vertical placement.

With liquid in the reservoir 203, and prior to use of the system 1000, the depletable unit II is coupled to the reusable unit I. The outlet plugs 2069 can then be removed, as shown in FIG. 10, thereby exposing the outlet openings 2065 and allowing passage of liquid. Secondly, commands are provided, for example by using the remote control unit IV, to enable the dispensing apparatus pump to push liquid out of the reservoir 203 and into the well 206 via the flexible tubing 205 extending between the reservoir and the well. Thereby, liquid is released through the outlet opening 2065, so that when the unit II is (properly) held and the outlet aperture 2065 is (for example) facing upwards, air is purged out of the unit II. Alternatively, prior to coupling, the air may be purged manually, as described above.

In turn, the inlet plug 2067 may be removed such that both the inlet aperture 2063 and the outlet aperture 2065 may be opened to allow the injection unit III to be freely inserted into the well chamber 206.

Figure 11 shows an example of the injection unit III partially snapped into the depletable unit II. As shown, at the bottom of the unit III, the sharp tip 3031 terminates at the penetrating end of the trocar 303 and is capped by the cannula 305. It can be seen that the cannula has pierced the skin S.

For piercing, the injection unit III is preferably moved towards and into unit II until it is fully engaged and sealed therein, and the trocar 303 is then withdrawn and moved away from the injection unit III and discarded.

At the top of the unit III, a handle 3033 is fixedly attached to the trocar 303. The handle 3033 itself as a separate part is not required by embodiments of the invention, as the gripping end 3035 of the trocar 303 may be formed as a handle, such as a hook or a loop, for example. In the configuration described below, the trocar 303 may have a solid cross-section like a dagger, or be hollow for air purging purposes, for example.

Still in fig. 11, the cannula 305 is open at the skin contacting end 3051 and is preferably securely connected to the plug 3053 at the opposite end. The plug 3053 can be configured with an edge 3055 that allows only unidirectional insertion through the inlet 2063 of unit II. At least one radial bore 3057 may be provided in the casing 305 to allow fluid communication from the interior of the well 206 into the inner cavity of the casing.

Fig. 12 depicts the cannula 305 inserted into the body B and completely sealed in unit II, and the trocar has been withdrawn. The cannula 305 may be anchored inside a closed loop (trap) 2071 formed in unit II by a plug 3053. The plug 3053 can be constrained between an extension 2073 at the rim 3055 and a spoiler (step) 2075. Plug 3053 seals liquid flowing into bore 206 through conduit 205 from escaping inlet opening 2063.

Similarly, according to some embodiments, liquid is prevented from escaping the outlet apertures 2065 by the cuff 2001, which acts as a seal, or by a special outlet seal 2076, or both. In the same manner, although not shown in the figures, it is possible to use viscoelastic cuff 2001 to seal inlet aperture 2063.

Thus, liquids contained within well chamber 206 are prevented from escaping through inlet opening 2063 and/or outlet opening 2065, but can flow into casing 305 through radial bore 3057 and out of the casing through outflow opening 3059. Thus, the liquid transferred from the reservoir 203 is provided for injection into the skin S or body B of the patient.

Fig. 13 is another embodiment of a well chamber, showing a well chamber 206 having an inlet opening 2063 and an outlet opening 2065. The inlet opening 2063 of the well chamber is disposed adjacent the distal surface relative to the inlet port 2003 disposed in the cuff 2001. The inlet port 2003 is blocked by an inlet seal 2085, which may simply be part of the enclosure 2001, or a viscoelastic seal embedded as an insert in the enclosure. The inlet seal 2085 may be produced using a two-layer injection molding or similar manufacturing technique.

The outlet opening 2065 of the well is preferably disposed adjacent the proximal surface relative to the outlet port 2005 disposed in the cuff 2001. Air may be purged through the outlet opening 2065.

Fig. 14 shows another embodiment of an injection unit III which has been inserted into the well 206 shown in fig. 13.

The injection unit III may comprise a ram portion (ram) 3038 arranged intermediate the handle 3033 and the cannula 305, which fits into the trocar 303. One side of the punch portion 3038 may be fixedly attached to the handle 3033 and the opposite side of the punch portion may be fixedly attached to the trocar 303. During insertion of the cannula 305 into the skin S or body B, the punch portion 3038 drives the cannula 305 by pushing on the handle 3033 until the handle 3033 is stopped by the abutment on the unit II. In the blocking position depicted in fig. 14, the casing 305 is held in place by friction at the well 206 and unit II.

Figure 15 shows the trocar 303 after withdrawal of the depletable unit II and ready for disposal. The cannula 305 remains in the body B, allowing fluid to flow out of the conduit 205, into the well 206, and from there through the cannula outflow opening 3059 into the cannula inlet opening 3063 and into the body.

Inlet opening 2063 and outlet aperture 2065 may be properly sealed to ensure that liquid flows only through casing 305, thereby preventing unwanted liquid from escaping and being lost from well chamber 206.

Fig. 16 shows the well 206 featuring a vent tube 2091 with a vent tube inlet 2093 and a vent tube outlet 2095, providing fluid communication from the interior of the well 206 to the exterior of the enclosure 2001. Snorkel 2091 may be inserted into well 206 and enclosure 2001; the well and envelope may be made of viscoelastic material to prevent liquid from flowing out only through the inner cavity of the vent tube 2091.

A cover may be included to cover the vent tube outlet 2095, but it is not shown in the figures because it has been removed prior to use. An inlet seal 2085 may be suitably disposed in the enclosure 2001, if desired. As described above, the air may be purged before or after the reusable unit I and the depletable unit II are coupled.

In fig. 16, the embodiment of the injection unit III is the same as the embodiment of the injection unit III of fig. 14 and 15. Once the injection unit III is inserted into unit II, the trocar 303 and cannula 305 pierce the cuff 2001 and well 206, and simultaneously the inlet seal 2085 (if fitted with it). During insertion, the bottom portion 3037 of the handle 3033 pushes the vent tube 2091 into the well 206 and seals the vent tube outlet 2095. The sleeve 305 is held in place by friction, as described above with reference to fig. 14 and 15.

Figure 17 shows the cannula 305 being driven by the cannula driver 3039, the cannula driver 3039 being securely retained on the handle 3033 of the trocar 303. The cannula driver 3039 is attached to the handle 3033 and to the trocar 303 in place of the punch portion 3038 shown in figures 14, 15 and 16.

The cannula driver 3039 cooperates with the cannula 305, the cannula 305 having external threads 3058 disposed adjacent an outer portion of the cannula inlet opening 3063. The cannula driver 3039 may be configured to engage the cannula inlet opening 3063 or a portion of the cannula adjacent thereto to enable longitudinal insertion into the well 206 and rotation of the cannula. The trocar 303 is preferably driven linearly into the well 206 and then rotated to engage the threads 3058 in a self-tapping manner, or to engage appropriately provided mating internal threads in the outlet opening 2065.

Once the cannula 305 is securely threaded and retained in the well 206, the trocar handle 3033 may be pulled out of the unit II, which may also withdraw the cannula driver 3039. The trocar inlet 3063 is now open to allow fluid to transfer from the well 206 into the skin S or body B.

In fig. 11, 12 and 14 to 17, the cannula 305 is shown inserted into the skin S in a vertical orientation. However, other configurations are possible that allow insertion of the cannula 305 at other desired angles, if desired.

Fig. 18 depicts a further embodiment of the dispenser provided with a rotary joint 60 enabling the injection unit III to be rotated in both clockwise and counter-clockwise directions for insertion of the cannula 305 at any angle from 0 ° to n360 ° and n ranges from 0 to ∞. In practice, the insertion can be performed at an angle in a range between the vertical and horizontal direction of the cannula with respect to the skin S.

FIG. 18 is a partial cross-sectional view of a plan view of unit II showing the downstream end 2051 of flexible tube 205 securely coupled in fluid communication to an inlet bore 2063 of well 206. In fig. 18, the well 206 is arranged in a horizontal position substantially parallel to the skin contact surface of the unit II.

The inlet apertures 2063 preferably open into the trapped cavity 2071 to form a chamber for liquid accumulation. This cavity is bounded by a spoiler 2075, thereby forming a cylindrical outlet aperture 2065 of the well 206, which emerges on the sidewall or elevation surface of unit II. In contrast, in the case of the well chambers shown in FIGS. 10 to 17, the inlet apertures 2063 are hidden and contained within unit II.

The swivel is provided with a swivel catch 61 that couples to the outlet aperture 2065 of the well 206. The outer portion 62 of the rotational fastener 61 supports the inlet seal 2085 and the sleeve 305, the sleeve 305 being provided with a radial bore 69. The casing is directed vertically toward the well 206. The swivel fastener is provided with an internal passage providing fluid communication with the well chamber and with the casing radial bore 69. The rotational fastener 61 includes an inner portion 63 terminating in a resiliently expandable jaw 65, and a cylindrical shank 66 intermediate the outer portion 62 and the jaw 65.

The inner portion 63 of the rotating fastener 61 is preferably retained within the cylindrical outlet aperture 2065. The resilient jaws 65 are prevented from backing out of the entrapment cavity 2071 by the spoiler 2075, and the stem 66 is able to rotate within the cylindrical exit aperture 2065. An O-ring seal 64 is disposed intermediate the cylindrical outlet bore 2065 and the stem 66 to prevent fluid leakage.

So that the rotational fastener 61 is free to rotate relative to the well 206 and the unit II. To prevent rotational loosening or to retain the rotational catch 61 in the desired position, the tongue 67 may be fixedly connected to the unit II so as to be received in a groove 68, the groove 68 opening onto the periphery of the outer portion 62 of the rotational catch 61.

The cannula 305 is available for outflow of liquid before introducing the "dagger" trocar 303 fitted with the handle 3033, and after filling the reservoir 203 and purging air. However, it is also possible to purge air when cannula 305 is mated to trocar 303. To this end, the trocar 303 is hollow and provided with a radial bore 69 for fluid communication with the well 206 and with the exterior of the unit II.

In fig. 18, a sleeve 305 is received within a clip 61 and is in a cut out (cutout) 71 provided within unit II. Fig. 19 shows a different embodiment of a swivel joint, wherein unit II is not provided with a shear 71. The arrangement of the tongue 67 and the groove 68 may be slightly different.

In both embodiments shown in fig. 18 and 19, unit III may be of different configuration. In fig. 18, the unit III may comprise a dagger trocar 303 fitted with a handle 3033, or a hollow trocar 303 with a handle 3033. Unit III may utilize any of the embodiments depicted in fig. 11-17.

In yet another embodiment, unit III comprises a trocar 303 and a rotational fastener 61 into which a cannula 305 has been inserted. In this case, the well 206 may be fitted with an outlet plug 2069, which may be a purge air removal outlet plug 2069.

Figure 20 shows, as an embodiment 2000, optional components integrated with the reusable unit I. These options may include an input/output device (or I/O device) 102, a security device 104, an alarm 106, and one or more rechargeable batteries 108.

An I/O device may be added on the outside of the distal end of the reusable unit I (on the side opposite to the unit attached to the skin S). Thereby providing additional means for communication. The I/O device 102 may be provided with input means such as button(s) and/or keys, or a USB port, and output means such as LEDs, or even a display if desired. The I/O device 102 is coupled to the controller and transceiver 101 and receives input and output commands from both the controller and transceiver 101 and from the user U.

The safety device 104 may be coupled to a separate flow sensor configured to monitor the fluid pressure pulses delivered to the downstream end 2051 of the flexible tube 205.

In contrast to the controller and transceiver 101, which derives the flow rate, i.e. the volume/time of the liquid delivered to the body B, as by equation (1) above, the safety device 104 can directly sense the liquid pressure pulses generated in the line 205. Additional stand-alone fluid flow sensors (not shown in the figures) may be added if desired to increase the reliability of the system 1000.

FIG. 21 is a schematic diagram of an exemplary pressure sensor apparatus. In the cross-sectional view it is seen that the tubing 205 is supported by a rigid base 2011 carried by the depletable unit II, while a rigid bridge 1041 is disposed on the reusable unit I, embracing the tubing 205.

The bridge 1041 may include one or more legs, and preferably two legs 1043 spaced apart and a distance, both of which may be supported on the base 2011 and include a beam 1045 supported by the two legs 1043. The separation line SL in fig. 21 represents the boundary between unit I and unit II, and thus marks the separation line between the bridge 1041 and the base 2011. When units I and II are coupled together for operation, the tubing 205 is tightly confined within the rigid frame formed by the bridge 1041 and the base 2011.

A piezoelectric pressure sensor 1047 (as an example of a pressure sensing device) may remain in the beam 1045 disposed opposite the base 2011 so as to directly mechanically contact the conduit 205. When a pulse of liquid surges inside the tube 205, the piezoelectric pressure sensor 1047 senses the pulse, which is converted into an electrical signal that is transmitted to the controller and transceiver 101 via a pair of wires 1049.

Fig. 22 schematically illustrates the advantages obtained from a configuration in which two legs 1043 are arranged to integrate the delivery contact 2209 and the receiving contact 107 into a pressure sensor device 1047.

The receiving contacts 107 may be disposed at a free end 1044 of each leg 1043, while the delivery contacts 2209 may be disposed on a base 2011 opposite the free end 1044. A wire 1048 may be electrically coupled to each receiving contact 107 through the interior of each leg 1043.

Wires 2013 may be electrically coupled to each delivery contact 2209 through base 2011. Although not shown in the figures, each or both of a pair of contacts including the transmit contact 2209 and the receive contact 107 may be spring loaded for better conduction, if desired.

The piezoelectric pressure sensor 1047 (which responds by transmitting a signal proportional to the amount of fluid 1055 flowing through the series of lines 205) facilitates detection of basal and bolus fluid flow patterns and reporting to the controller and transceiver 101 accordingly. Also, it is easy to detect and report high pressures, such as caused by clogging, or low pressures, such as caused by leakage, e.g. detachment or rupture.

In a series of pressure pulses, each pulse is characterized by having: amplitude a, pulse width w, and distance T separating two consecutive pulses (representing period T).

Fig. 23 shows, as an example, a diagram of a pulse train obtained by the piezoelectric pressure sensor 1047 with respect to a set of coordinate systems having an abscissa t representing time and an ordinate y indicating amplitude. The pressure pulse waveform contains information about the operating state of the system 1000, such as the operating state of the system 1000 represented by the three parameters A, w and T.

The amplitude a may be proportional to the pressure of the liquid in the line 205 and preferably remains within predetermined limits. The higher the amplitude a, the higher the pressure, which may indicate a blockage. Conversely, a low pressure may indicate a leak, such as a rupture, release, disconnection, or even the absence of liquid.

In one embodiment, the period T may be proportional to the rotational speed of the wheel 1051 of the transfer element 105, and thus proportional to the volume of the injected liquid amount. In fig. 23, the curved surface defined between the curve of the measured pressure wave and the abscissa T thus represents the flow rate Q of the injected liquid, comparable to the product of a and w divided by T, as expressed by equation (2):

Q=k*A*w/T[mm³per minute] （2）

The coefficient k is a one-dimensional empirical coefficient and depends on the internal diameter of the pipe 205.

The safety device 104 is a useful stand-alone tool that enhances the reliability of the system 1000 by delivering an alarm upon detecting a trend toward a dangerous condition or a trend toward a dangerous imminent occurrence in some embodiments of the present invention.

Although not shown in the figures, one or more safety devices 104, such as flow sensors, may be added in place of or in addition to the pressure sensor 1047.

An alarm module 106 may be provided which may be coupled to a receiving contact 107 providing electrical energy and may be coupled to the controller and transceiver 101. The alarm module 106 may provide an alarm in response to a hazard signal issued by the controller and transceiver 101 and/or the safety device 104. The alarm module 106 may be implemented to emit audible, visual, or sensory signals through a buzzer, a light, or a vibrator, respectively. The vibrator is a preferred implementation because the unit I is arranged on the skin S and preferably also because the signal provided is a signal that the person can only feel, without getting the attention of the person around him.

An alarm is given in response to a signal from the controller and transceiver 101, according to at least one of the following: engine 103 detects unacceptable conditions and performance, signals from reusable sensors 21, or signals from security device 104. The security device 104 may be coupled to the alarm module 106 via the controller and transceiver 101, or directly to the alarm module 106, although such connections are not shown in the figures.

The engine 103, security device 104 and transmission element 105 are only started after establishing the operative connection of the reusable unit I with the depletable unit II. In parallel, the controller and transceiver 101 may transmit wireless alarm signals to the remote control unit IV, which may relay these alarm signals to other external receiving devices, computers and networks.

Optionally, a battery (which may be rechargeable battery 108) is also integrated into the reusable unit I to provide additional reliability to the system 1000. The battery 108 is charged by connecting to an external battery charger via a charging port.

In fig. 20, the controller and transceiver 101 is shown coupled to the I/O device 102, the engine 103, the security device 104, the transmission element 105, the alarm 106, and in two-way wireless communication with the remote control unit IV. The controller and transceiver 101 may be microprocessor driven for commanding and managing the units I and II, and the controller and transceiver 101 may be configured to support two-way wired or wireless communication with the remote control unit IV.

Fig. 24 shows an exemplary block diagram presenting the electronics of the controller and transceiver 101, the controller and transceiver 101 being a control module with a transceiver. A microprocessor (μ P) 1011 having one or more memories 1012 is coupled to the transceiver 1013 having an antenna 1014. The μ P1011 may also be coupled to the engine driver 1015, the A/D converter 1016, and the A/D converter 1016 in turn coupled to the MUX 1017. The μ P1011 may be configured to read, manipulate and execute computer programs stored in one or more memories 1012 (hereinafter referred to as memories 1012) and respond to instructions and commands.

For example, the μ P1011 receives commands from the remote control unit IV via the antenna 1014 and the transceiver 1013, and then fetches data and computer programs from the memory 1012 and stores the data in the memory 1012. The transceiver 1013 is also preferably in communication with the memory 1012 to store programs and data in the memory 1012 and retrieve data therefrom. The transceiver 1013 communicates with the remote control IV via an antenna 1014 and, if necessary, with other receivers, transmitters or transceivers not shown in the figures.

The μ P1011 then issues a command to the engine driver 1015 to start the engine 103 and receive feedback from one or more security devices 104. From the received feedback, the μ P1011 may obtain a comparison and, if necessary, issue a correction command to the engine driver 1015.

Feedback received by the security device(s) 104 from the analog sensors may be fed to the μ P1011 via the MUX 1016 and converted to a digital signal by the a/D converter 1017.

Also, data and commands may be exchanged between μ P1011 and I/O device 102. μ P1011 may also activate alarm 106 if necessary. Power for operating the μ P1011 may be obtained from the receive contact 107. the receive contact 107 is coupled to the batteries mounted in unit II or to an optional battery (whether rechargeable or not) 108 mounted on unit I.

In practice, the electronic circuitry of the controller and transceiver 101 can be integrated in a manner well known in the art, such as a single chip with low power consumption, e.g. an ASIC, e.g. aAnd the like.

Fig. 25 shows unit I and unit II separated from each other, while unit III is symbolically depicted as being coupled with unit II even if shown in the plane of the paper rather than the plane perpendicular thereto. The unit II may comprise a detachable latch arm 21 and a recess 23 for receiving the unit I. Unit I may include a latching recess 22 configured to engage the latching arm 21 to securely but removably hold units I and II together.

In some embodiments, when units I and II are latched together, as shown in fig. 26, wheels 1051 and sensor 1047 properly abut tubing 205 and, similarly, delivery contacts 2209 snap into receiving contacts 107.

Fig. 27 is a side view of the latched units I and II. A strip of release tape 24 is covered with a layer of adhesive 25. After tearing off the tape 24, the unit II can be brought into contact with the skin S (not shown in fig. 27) and attached thereto. If desired, but not shown in FIG. 27, a binder may be added to Unit I in the same manner as described for Unit II.

Fig. 28 presents another embodiment, again showing units I and II separated from each other, while unit III is again symbolically depicted as coupled with unit II in the plane of the paper rather than perpendicular thereto. Unit II is shown as having a cradle 28 for removably receiving unit I therein.

Fig. 29 depicts unit I securely snapped into the holder 28, but removable therefrom when depleted. In the same manner, as for unit II in FIG. 27, the bottom of unit I may also be covered with a release tape 24 covered with a layer of adhesive. An O-ring 29 or other sealing element 29 may be coupled to unit I to ensure a seal when engaged with unit II.

It will be appreciated by those skilled in the art that other releasable snap-on mechanisms may be used as well to securely couple units I and II when engaged.

Fig. 30 is a block diagram of an example of the remote control unit IV, which is a hand-held device operated by the user U. In some embodiments, the remote control unit IV is a user interface with the system 1000, through which programs and/or commands are transmitted and received, and operates and controls the system 1000.

As shown, a microprocessor-driven command and control unit 401 (which is capable of executing computer programs stored in memory 403) is coupled to a transceiver 405, which transceiver 405 in turn is coupled to an antenna 407 for wireless bi-directional communication with at least unit I. Communication with external devices, computers and networks is also possible, if desired. The command and control unit 401 may be coupled to a display 409 and to an alphanumeric keyboard 411. An alarm device 415, such as an LED, buzzer or other known device, may be further coupled to the command and control unit 401.

With, for example, the system 1000, and with other external and remote devices, computers, and networks, exchange of information, such as computer programs, memory data, instructions, and commands, may be accomplished not only via the transceiver 405, but also via the infrared port (or IR port) 421 and USB port 423.

The operation of the remote control unit IV may be powered by a battery 425, the battery 425 being replaceable, or may be reloadable via a battery charging port 427. The battery may power the command and control unit 401, the transceiver 405, the display 409 and the alarm device 415. It should be noted that the battery 425, the memory 403, the USB port 423, and the alarm 415, which are shown as a single device in fig. 30, may be implemented as a plurality of devices, if desired.

For operation, the memory 403 of the remote control unit IV may be loaded with programs via the transceiver 405, or via the IR port 421, or via the USB port 423. For liquid infusion, the user U may enter commands and commands via the keypad 411 as needed to communicate with the controller of the reusable unit I and the transceiver 101 via the transceiver 405 and the antenna 407.

Information received from sources external to the units of system 1000 and data received from unit I may be displayed on display 409. The command and control unit 401 may analyze the state of the system and receive data for outputting selected information and necessary alarms to the display 409 and alarm 415, respectively. The display 409 is also capable of displaying various status data such as fluid delivery rate, actual operation of the computer program, and battery status.

Data exchange and communication processes may be managed by ensuring data security and data integrity, and utilizing known techniques of known handshaking protocols and secure communication protocols, all of which are well known in the art.

A handheld I/O device can be arranged on the remote control unit IV, which has a display 409, a keyboard 411 and an alarm 415.

The operations of system 1000 are described below by way of example only, as the order of execution of the operations may vary.

Before use (and preferably at manufacture) the general programs, instructions and commands can be preloaded into the remote control IV, after which the personalization data for the individual user U can be added.

For treatment, the user U selects the liquid to be injected, e.g. insulin, and further the desired type of unit II. If the reservoir 203 in unit II is not pre-filled, the user U may manually fill the reservoir 203 taking care to purge air therefrom. Then, the unit II with the reservoir 203 is operatively coupled to the reusable unit I. The user U now selects the type of cell III as required or desired. In turn, unit III is inserted into unit II to establish fluid communication therewith, after which the user U commands the transmission element 105 to perform an operation of purging air from the cannula 305. Next, unit III is operated to insert the cannula 305 into the skin S or subcutaneously into the body B, and the operatively assembled units I, II and III are suitably arranged with at least unit II attached to the skin.

When unit II is coupled to unit I, unit I is powered from a single or multiple batteries via delivery contact 2209 and receiving contact 107. The controller and transceiver 101 executes computer programs and instructions, such as user U commands, via the unit IV or via the I/O device 102. Computer programs and instructions, as obtained from an external source, may also be delivered to the controller and transceiver 101. Transmissions from an external source may be captured by unit IV through wireless transceiver 405, via antenna 407 or IR port 421, or by wire, via USB port 423. Such external transmissions may be received from a remote computer or network from a device external to system 1000.

Upon command, the liquid is dispensed from the reservoir 203 according to a computer program stored in memory, or in response to a command from the user U. The engine 103 then activates the transfer element 105 operating in conjunction with the tubing 205 and backing 207 to fill the well 206. Unit III propels fluid from well 206 through skin S and subcutaneously through body B.

Error-free operation of the system 1000 may be monitored by the controller and transceiver 101 and, for increased reliability, error-free operation of the system 1000 is also supported by feedback signals received from the reusable sensor 21 arranged on the transmission element 105 and/or from the safety device 104 coupled to the disposable sensor arranged on the unit II.

To further enhance the reliability of the system 1000, at least one rechargeable battery may be disposed within the unit I.

Thus, the system 1000 is an example of a sustained release delivery system for delivering beneficial fluid to the skin S or body B at a predetermined rate.

While several embodiments of the present invention have been described, it will be appreciated by those skilled in the art that the foregoing is illustrative only and not limiting, and that numerous changes may be introduced in these embodiments without departing from the true spirit of the invention as defined in the claims.

Claims (12)

1. A fluid dispensing device for continuous medical infusion of a fluid, comprising:

a reusable unit (I) comprising:

a controller (101) for managing operations, an

An engine (103) for imparting motion to a fluid transfer element (105) of a fluid transfer system, a primary portion of the fluid transfer element (105) being located in the reusable unit (I);

a depletable unit (II) comprising:

a secondary portion of the fluid transfer element (105) of the fluid transfer system;

a reservoir (203) for holding the fluid,

a conduit (205) coupled to the reservoir (203) for conveying liquid from the reservoir (203), and

a well chamber (206) coupled in fluid communication with the tubing (205); and

an injection unit (III) configured to be inserted into the depletable unit (II) at the well chamber (206), the injection unit (III) comprising:

a cannula (305) for insertion into the body of a user through the well (206), and

a trocar (303) adapted to the cannula (305) and having a sharp tip (3031) piercing the skin (S) of the user;

wherein when the reusable unit (I) and the depletable unit (II) are coupled in a co-operable manner and the injection unit (III) is coupled to provide fluid communication with the depletable unit (II), fluid is transferred out of the depletable unit (II) for injection upon powering the engine (103).

2. The fluid dispensing device of claim 1, wherein the reusable unit (I) is configured to be detachably latched to the depletable unit (II) and at least the depletable unit (II) is detachably affixed to the skin (S).

3. A fluid dispensing device according to claim 1 or 2, wherein the cannula (305) is insertable into the skin (S) at any desired angle.

4. A fluid dispensing device according to claim 3, further provided with a rotary joint (60) to enable rotation of the injection unit (III) in both clockwise and counter-clockwise directions for insertion of the cannula (305) at any desired angle.

5. A fluid dispensing device as claimed in claim 1, wherein the well chamber is provided with a line inlet (2061), an inlet bore (2063) and an outlet bore (2065), the downstream end (2051) of the line (205) being attached to the line inlet (2061).

6. A fluid dispensing device as claimed in claim 5, wherein each of the inlet aperture (2063) and the outlet aperture (2065) is removably hermetically sealed by a sealing means (2067, 2069).

7. A fluid dispensing device as claimed in claim 5, wherein the well chamber (206) extends from the inlet aperture (2063) to the outlet aperture (2065) such that the well chamber (206) passes substantially directly through the entire height of the depletable unit (II).

8. The fluid dispensing device of claim 1, wherein the trocar (303) is configured to be withdrawn and exit the injection unit (III) after the injection unit (III) moves into the depletable unit (II) and fully bites and seals therein.

9. A fluid dispensing device as claimed in claim 1, wherein the sleeve (305) is provided with at least one radial bore (3057) to allow fluid communication from the interior of the well (206) into the inner cavity of the sleeve (305).

10. The fluid dispensing device of claim 1, wherein the depletable unit (II) comprises a cradle (28) for removably receiving the reusable unit (I).

11. The fluid dispensing device of claim 1 wherein the fluid is insulin.

12. A fluid dispensing system for continuous medical infusion of a fluid, comprising:

a fluid dispensing device as claimed in any preceding claim; and

a remote control unit (IV).