Medical injection device mountable to the skin

BACKGROUND OF THE INVENTION

The description of the present invention most often refers to the treatment of diabetics by insulin injection or infusion, however, this is only an example application of the present invention.

Portable medication delivery devices for delivering medication to a patient are well known and generally include a reservoir adapted to store liquid medication and having an outlet in fluid communication with a cavity filler needle as well as expediting agents for expelling medication from the reservoir and through the skin patient with the cavity needle. Such devices are often called infusion pumps.

In principle, infusion pumps can be divided into two classes. The first class includes infusion pumps, which are relatively expensive pumps intended for use by

- 4 years, which is the reason that the initial cost of such pumps is often a barrier to this type of therapy. Although more complicated than traditional syringes and pens, the pumps offer benefits such as continuous insulin infusion, precise dosing and optionally programmable dosing profiles and user-activated additional infusions in relation to meals consumed.

In order to solve this problem, it has made several attempts to provide second class infusion devices that have a low price and are convenient to use. Some of these devices are partially or completely disposable and can provide many benefits associated with infusion pumps, without associated costs and inconveniences, e.g., pumps may be pre-filled, thus avoiding the need to fill or top up the medicine. Examples of infusion devices of this type are known from US Patents 4,340,048 and 4,552,561 (based on osmotic pumps), US Patent 5,858,001 (based on a piston pump), US Patent 6,280,148 (based on a diaphragm pump), US Patent 5,957,895 (based on a pump with flow limiter) (also known as the bleed pump), US Patent 5,527,288 (based on a gas generating pump), or US Patent 5,814,020 (based on a swelling gel), which have been proposed in recent decades as cheap, mainly disposable drug infusion devices. US Patent 6,364,865 describes a hand-held infusion device enabling the connection of two vial-type containers and pressurizing one of the containers to dispense the drug contained in that container. US Patent 4,886,499, which forms the basis for the preamble of claim 1, describes a portable transdermal injection device comprising a disposable portion and a reusable portion.

Disposable pumps generally have a skin-contact mounting surface adapted to be applied to the patient's skin by means of adhesives and an infusion needle disposed so that during use, the needle protrudes from the mounting surface to penetrate the patient's skin. in which the needle penetrates the skin is covered when using the device. The infusion needle can be positioned so that it constantly projects from the mounting surface and the needle is introduced simultaneously using an infusion pump as described in US Patent 2,605,765; 4,340,048 and EP 1 177 802, or the needle can be supplied with the device in a retracted position, i.e. such that the distal, pointed end of the needle is "hidden" inside the pump structure, so that the user can place the pump on the skin without being able to see the needle as described in US Patent Nos. 5,858,001 and 5,814,020. In addition to pumps, alternative means for transporting the liquid medicine, e.g., iontophoresis, may be used as described below.

Although it can be expected that the second class of disposable infusion devices described above can be manufactured much cheaper than traditional, durable infusion pumps, they are still considered too expensive to be used as a real alternative to traditional infusion pumps in everyday practice.

Before proceeding with the description of the present invention, various types of devices will be described regarding the introduction of a needle or needle-like structure.

Although drug infusion pumps, both disposable and durable, can provide convenience in use and improve treatment control, they have long sought to provide a drug infusion system for the treatment of e.g. diabetics that would be based on closed-loop control, i.e. more or less fully automatic. The work of the system should be based on measuring the value of the parameter indicating the condition being treated, e.g. blood glucose level in the case of insulin treatment of diabetics.

Such a control system for measuring the concentration of a given substance may be based on invasive or non-invasive measurement methods. An example of the latter is non-invasive glucose control, performed on the patient's skin surface using near infrared spectroscopy, however, the present invention mainly relates to devices comprising a transdermal device, such as a needle sensor element.

The sensor can be placed subcutaneously and can be connected to an external device using cables, or the substance (e.g. fluid) to be analyzed can be transported to an external sensor element, both solutions requiring the placement of a subcutaneous component (e.g. a small catheter or tubes); the present invention relates to both such solutions. However, for simplicity, the term "sensor" is used hereinafter for both types of elements introduced into the patient.

IDEA OF THE INVENTION

Considering the abovementioned problems, it is an object of the present invention to provide a drug delivery device or system placed on the skin and appropriate components so that such device or system is used in a convenient and economical manner. The configuration of the system and components should ensure the delivery of medication delivery means that allow easy and quick operations to be carried out and are reliable in use.

In the description of the present invention, examples and aspects are described that relate to one or more of the above purposes, or which relate to the objectives resulting from the description below as well as from the description of the embodiments.

Thus, regarding the first aspect, there is provided a medical device comprising a percutaneous unit and reservoir unit as defined in claim 1.

The term "transdermal" includes any form of drug delivery in which fluid is transported through a portion of the skin, e.g., intradermal or subcutaneous administration. "Transdermal" agents may be in the form of a transdermal device, pressurized jet injectors or electrodes that allow the ionic agent to penetrate from a specific location on the skin surface to the patient's subcutaneous tissue using ionophoresis principles. A more detailed discussion of iontophoresis is provided in US Patent 6,622,037. Depending on the nature of the transdermal means, expelling agents may have a different configuration and nature. For example, when one or more of the cavity infusion needles or cannulas are used, expelling agents can push or aspirate liquid medicine from the reservoir, while in ionophoresis, expelling agents are agents used to apply current to the electrode set, i.e. "propulsion" measures.

The transcutaneous device, the detachable connecting means, and the reservoir may include enabling the reservoir to be attached to the transcutaneous device for use. Such a medical device containing two units can also be regarded as a medical system. Both the transcutaneous device unit and the reservoir unit may have housings in which the transdermal device is housed, respectively the reservoir and expedition assembly.

The term expedition means a collection of components or structures that, in combination, ensure that fluid can be expelled from the tank. The expedition assembly is in the form of a mechanical pump (e.g. diaphragm pump, piston pump or roller pump) in combination with electronically controlled drive means. The expedition assembly can also be in the form of a set of components or structures that in combination ensure that fluid can be expelled from the tank when the expedition assembly is controlled or activated by a controller located outwardly relative to the expedition assembly.

Transdermal device (with the term also including similar terms: the device for getting through the skin and the tool for getting through the skin, traditionally used in the field) can be in the form of a pointed, cavity infusion needle, array of micro needles or a combination of relatively flexible per se, thick cannulas with sharp introduction needles, can be pointed a transdermal device, the introducing needle being removable after inserting a thick portion of the transdermal device. In the latter case, the part of the transdermal device actually placed in the patient and then withdrawn by the retraction means described herein does not need to include a pointed end enabling the transcutaneous device to be inserted through the skin, such a pointed end is withdrawn when the transcutaneous device is inserted . The cannula is preferably soft and flexible relative to the insertion needle, which is usually a strong steel needle. In the description of the present invention, as well as in the description of the embodiments, references are made to the transdermal device in the form of an infusion needle. The length of the transcutaneous device can be selected to suit the application, e.g. the hollow steel needle, which can be inserted at a substantially right angle to the skin surface, can have an insertion length of 2 - 8 mm, preferably 3 - 5 mm, while the cannula, which can also be inserted obliquely into the skin surface, can be slightly longer , e.g. 4 - 20 mm.

The mounting surface is adapted to be applied to the skin of an object (e.g. user or patient) and can be kept in contact with the skin by mounting means external to the mounting surface (e.g. connecting means, allowing the medical device to be connected to the skin-attached device) , or adhesive bandage or dressing) or by means of adhesive provided on the mounting surface. The mounting surface can also be adapted for mounting on the skin using an intermediate component or device mounted on the skin, e.g. the device mounted on the skin may comprise a gripping portion to which the medical device is attached, the transdermal device being inserted into the skin through the opening in the grip part.

The above arrangement enables the implementation of various concepts. For example, by providing at least two variations of one of the devices, two or more combinations can be obtained, with each combination of the transdermal device and reservoir providing an assembly with different properties, as will be discussed in more detail below. In the event that the devices are delivered with detachable connecting means, one of these devices may be replaced by a new or other device, while allowing the reuse of the other device, thus extending the lifetime of the device being reused. Thus, the present invention according to the claims provides an embodiment of the device in which the components providing the user interface are located in the first device, while the components providing the delivery of drugs per se are located in the second device, ensuring the joining and replacement of components in a simple, reliable and user friendly way.

For example, the reservoir may be supplied with a certain amount of medication and a metering pump containing an energy source enabling delivery of the medication e.g. for 10 days, while the transcutaneous device unit can be equipped with a transcutaneous device and a sticky surface on the mounting surface with an expected (or recommended) lifetime of 2 days, which allows using a tank with 5 units of the transcutaneous device for 10 days , which significantly reduces the overall usage time of the connected device. The tank may be pre-filled or may be adapted to be filled one or more times.

On the other hand, the percutaneous device unit can be equipped with, for example, a needle or soft cannula and adhesive agents (e.g. of the type used to attach containers to a colostomy) so that the needle can be mounted and used for a longer period of time, with the container being shorter life expectancy, e.g. when relatively large quantities of medication must be filled. Alternatively, different reservoirs, with different types of medication, can be used in combination with such a "long-lasting" mounted needle.

To facilitate use, a fluid connection between the needle and the reservoir can be established when the needle and reservoir are connected to each other, for example, expelling means can be activated when the needle and reservoir are connected to each other and are turned off when the units are disconnected . In practice, one or both operations can be performed manually by the user.

In an embodiment, the expelling assembly includes a pump having an inlet adapted to form a fluid connection to the outlet of the reservoir and an outlet adapted to form a fluid connection to the transdermal device, whereby the transcutaneous device can achieve a fluid connection to the interior of the container. Thanks to this arrangement, the pump serves as a suction pump that draws medicine out of the tank, which consequently must either be folded or ventilated if a non-foldable tank is used. The expelling assembly may also be in the form of a system adapted to generate pressure in the tank, e.g. a system for driving the piston in the tank containing the sliding piston. The reservoir unit may contain more than one reservoir and more than one expedition assembly can be used to expel medication from more than one reservoir, either simultaneously, while mixing medications, or alternately, or each reservoir may be equipped with an expedition assembly, which may be attached to a common transcutaneous device or to an individual transcutaneous device, e.g. the transcutaneous device unit may comprise more than one transcutaneous device adapted to be connected to the expelling team.

To initially provide a sterile flow path through the pump, the flow path may be located between the inlet and outlet so that the inlet and outlet seal the inside of the pump and thus the flow path in the sterile initial state. In this system, it is not necessary to supply the tank unit as a completely sterile unit - in practice, the medicine must be delivered sterile.

In an embodiment, the reservoir unit can be transformed from an initial state in which there is no flow connection between the pump and the reservoir, to a non-reversible operational state in which the flow connection between the pump inlet means and the outlet means of the reservoir is established when the pump unit is attached to the needle unit for the first time. This arrangement avoids introducing unwanted matter into the tank when the pump is reconnected to the tank.

In order to ensure a clean connection between the pump and the tank, a separate flow connection can be made inside the pump in its initial state. Such flow connection may include a pointed inlet and outlet end, while the pump inlet and outlet of the reservoir may be in the form of two needles permeable. In this arrangement, the pointed end of the flow connector, e.g. the connecting needle can be inserted into both septum, and thus between the initial state and the operating state in which the flow connection is established between the interior of the tank and the interior of the pump via a flow connector, the outlet of the flow connector is located in the flow path. Preferably, the flow connector is moved between two positions when the reservoir unit is connected to the transcutaneous device unit for the first time. Accordingly, during such a first connection, two flow connections will be established (between the percutaneous device of the percutaneous device unit and the pump, and between the pump and the reservoir), while during subsequent connections, only a single, new flow connection (between the device through - skin unit of the transcutaneous device and pump).

In an embodiment, the transcutaneous device includes a first portion having a pointed distal end and a second portion in fluid communication with the first portion and having a second end. Preferably, the second end of the percutaneous device is pointed and the pump outlet means include a needle permeable septum, allowing a fluid connection to be established between the other end of the percutaneous device and the inside of the pump, preferably when both units are connected to each other.

Accordingly, in another aspect, the present invention according to the claims provides a medical device as described above and comprising a pump having inlet means adapted to form a fluid connection from fluid sources and outlet means, the pump comprising an internal flow path located between the inlet and outlet means. the inlet and outlet means seal the inside of the pump, and thus the flow path, in a sterile initial condition, wherein the flow connection means are located inside the pump in an initial state, the flow connection means comprising inlet and outlet ends, the flow connection means being adapted to transition between the initial state and the operating state in which the inlet end projects from the inlet means of the pump . whereby the flow connection can be established between the fluid source and the interior of the pump by means of the flow connection means and with the outlet of the flow connection means located in the flow path.

The percutaneous device unit may be provided e.g. with a needle protruding from the mounting surface, however, to reduce the risk of accidental needle injury, the pointed end of the transdermal device is preferably moved between an initial position whose pointed end is retracted from the mounting surface, and an extended position in which the pointed end extends relative to the mounting surface. Depending on the intended method of mounting the device on the user, the transcutaneous device can be moved between both positions when both units are connected to each other, as is convenient when the transcutaneous device unit is attached to the user's skin before attaching the reservoir unit . However, in the case where two units are intended to be joined to each other before the assembled units are attached to the user's skin, the transcutaneous device unit preferably includes user actuated drive means for moving the pointed end of the transcutaneous device between the initial and extended positions.

To prevent unwanted activation of the percutaneous device before assembling both units, the percutaneous device unit may include means for blocking the propulsion means, the blocking means being released when the percutaneous device and reservoir units are connected to one another, enabling thus activating the drive means.

To further reduce the likelihood of injury through the transcutaneous device, the pointed end of the transcutaneous device may be moved between the extended position in which the pointed end extends relative to the mounting surface and the retracted position in which the pointed end is retracted relative to the mounting surface. Accordingly, the combined device may include a user-actuated retraction means for moving the pointed end of the percutaneous device between the extended and retracted positions when the reversing means are actuated. In order to prevent reuse of the transcutaneous device, the transcutaneous device may be permanently locked in the retracted position.

In order to avoid user errors, the drive means for introducing the transcutaneous device may cover the reversing means in the initial state, the actuation of the driving means exposing the reversing means. For example, the driving means may be in the form of gripping means (e.g. tapes) that are removed from the device, the removal of which triggers the insertion of the transcutaneous device and at the same time reveals the reversing means for withdrawing the transcutaneous device.

As described above, the expedition assembly can be activated and deactivated when both units are assembled and dismantled, however, drive and retraction means can also be used to activate and deactivate the expedition assembly. As with the initial connection between the pump and the tank, the initial activation of the expedition assembly can activate the electronic control means, as a result of which the pumping action will be activated, while the subsequent deactivation will deactivate only the pumping action and the control means will still be active (e.g. counting time from initial activation of control means).

In the above description of the invention, the two units are generally described as "single" units, however, this is only an example configuration and these two "main" units can be divided into several units if desired. For example, the tank unit can be equipped with a replaceable control unit, allowing different types of control units to be connected to the same tank unit, e.g. the first type of control unit may provide a single delivery profile, the second control unit may be programmable to modify the delivery mode, and the third control unit may include means for communicating the control unit with external means. In the last case, the control unit can be controlled using a wireless remote control. Accordingly, the reservoir can be removable, allowing the use of reservoirs of different sizes for different types of medication.

In an embodiment, the transdermal device unit may be provided with a cavity needle having a pointed distal end with an exit opening adapted to penetrate the patient's skin, and the pointed proximal end with an inlet opening forming fluid inlet means, the fluid inlet means being adapted to creating a fluid connection to the fluid source. In this arrangement, the needle provides a hydraulically stiff flow connection between the inlet and outlet of the needle (e.g. made of metal), so that obstruction can be detected early by controlling the pressure increase in front of the needle.

In yet another aspect, a system is provided comprising a first needle unit and a first reservoir unit as described above in combination with at least one other needle unit or reservoir unit as described above, wherein the other units have different properties than the first units. Other possibilities may relate to any design feature of the units, e.g. the type of needle, the type of user actuated means, the type of delivery / pumping means, or the type of container / medicine.

In particular, in an embodiment, a system is provided comprising a transcutaneous device unit as described above and a plurality of reservoir units, each comprising a fluid medication reservoir and an expelling assembly for expelling liquid medication from the reservoir. The transcutaneous device unit and the reservoir units include matched connecting means for attaching the reservoir unit to the transcutaneous device unit to create a flow connection between the reservoir and the transcutaneous unit, each combination of the percutaneous device unit and reservoir unit providing a set of other properties. Different properties can be obtained e.g.

by providing tank units with different amounts of the same medicine, tank units with different drugs or varieties of a given medicine, tank units adapted to expel the medicine at different predetermined rates, tank units adapted to expedite at constant, appropriately selected, speeds. One of the tank units can be equipped with a processor that controls the expedition assembly and a receiver, which works in conjunction with the controller to receive flow instructions from a separate control device and to provide instructions regarding flow to the processor. The receiver can be a wireless receiver. The tank units can also be equipped with various input means (e.g. for wireless or wired connections, or for manual data entry) or different output means (e.g. for wireless or wired connections, different display means or different alarm means).

In another embodiment, a system is provided comprising a plurality of transcutaneous device units as described above and a reservoir unit containing a fluid medication reservoir and an expelling assembly for expelling liquid medication from the reservoir.

The transcutaneous device units and the reservoir unit include matched connecting means to connect the transcutaneous device unit to the reservoir unit to form a fluid connection between the reservoir unit and the percutaneous device, with each combination of the percutaneous device unit and reservoir unit providing an assembly with different properties. Different properties can be obtained by equipping transdermal device units with different transcutaneous devices, e.g., a cavity hypodermic needle, a cannula and needle assembly, and a micro-needle array, by providing different adhesives, different means of insertion or retraction, or by providing different means connecting.

In yet another embodiment, a system is provided comprising a transcutaneous device unit, including a transcutaneous device and mounting surface adapted to be applied to a patient's skin, a tank unit containing a fluid medicament reservoir, and at least a portion of an expediting assembly for fluid expedition medicines from the tank and numerous control units, each containing a controller for controlling the expedition team, each with different properties. The transcutaneous device unit and the reservoir unit include matched connecting means to attach the reservoir unit to the percutaneous device unit to create a fluid connection between the reservoir and the percutaneous device and the control units and the reservoir unit include matched connecting means to attach the control unit to the tank unit to control the expedition team, whereby each combination of the percutaneous device unit, reservoir unit and control unit provides an assembly having different properties. The control units may have various control functions as described above in relation to a system comprising a plurality of tank units. In an alternative configuration, the reservoir unit and transcutaneous device unit may be provided as individual structures adapted to cooperate with the control unit.

The term "medicine" as used herein includes any liquid medical media containing drugs that can be passed through delivery means, such as a cavity needle, in a controlled manner, for example in the form of a liquid, solution, gel or fine suspension. Representative drugs include pharmaceuticals such as peptides, proteins and hormones, biological or active agents, hormone or gene based agents, nutrients and other substances in both solid (dispersed) and liquid form, insulin references will occur. Accordingly, the term infusion includes any method of transdermal delivery to a patient. In addition, the term "needle" (unless otherwise specified) means a piercing element adapted to penetrate the patient's skin.

In the description of subcutaneous use "

BRIEF DESCRIPTION OF THE DRAWINGS

Below, the skin-mounted device will be described with reference to the drawings, whereby

Figures 1-11 show in perspective views the sequence of using the first embodiment of the drug delivery device,

Fig. 12 shows another embodiment of the tank unit,

Fig. 13 shows the assembled needle unit and reservoir unit for another embodiment of the drug delivery device,

Fig. 14 is an exploded view of the needle unit of Fig. 13;

Fig. 15 is a perspective view of the needle unit of Fig. 13 in a first condition,

Fig. 16 is a perspective view of the needle carrier of Fig. 14;

Fig. 17 is a perspective view of the needle unit of Fig. 13 in a second condition;

Fig. 18 is a side view of the needle unit of Fig. 13;

Fig. 19 is a different perspective view of the needle unit of Fig. 13;

Fig. 20 is a perspective view of the interior of the reservoir unit of Fig. 13;

Fig. 21 is an exploded view of another tank unit;

Fig. 22A shows a diagram of connecting a pump to a tank;

Fig. 22B is an exploded view of the pump assembly;

Fig. 22C is a cross-sectional view of the pump assembly of Fig. 22C;

Figures 22D and 22E partly show in cross-sections the pump assembly of Fig. 22C;

Figures 23A and 23B schematically show a transcutaneous device in the form of a combination of cannula and insertion needle;

Figure 24 shows a perspective view of another drug delivery device;

Figures 25A-25D show other expelling means suitable for expelling fluid from the reservoir;

Fig. 26 shows a medical device with a modular tank unit, while

Fig. 27 shows a modular system for a medical device.

In the figures, the same constructions are identified by the same reference numerals.

DESCRIPTION OF EXECUTION EXAMPLES

When in the following description, relative terms such as "upper" and "lower", "right" and "left", "horizontal" and "vertical" or similar are used, they refer only to the attached figures and not to the actual situation of use . The figures shown are schematic representations and for this reason the configuration of the various constructions as well as their mutual dimensions are for illustrative purposes only.

Firstly, with reference to Figures 1-12, an embodiment of a drug delivery device will be described paying attention mainly to user-related properties. The transdermal device unit 2 includes a transdermal device in the form of a hollow infusion needle and will thus be referred to as the needle unit hereinafter, however the needle may be replaced by any desired transcutaneous device suitable for delivering fluid medicine.

In particular, Fig. 1 shows a perspective view of a medical device in the form of a modular skin mounted drug delivery device 1, comprising a needle unit 2 in the form of a lobe and a reservoir unit 5. During delivery to the user, each unit is preferably enclosed in its own, airtight housing (not shown).

The needle unit includes a base 10 with a lower mounting surface adapted to be applied to the user's skin and a housing 20 in which a cavity infusion needle (not shown) is located. The needle includes a first needle portion having a pointed distal end adapted to penetrate the skin of the user and a second pointed end adapted to form a fluid connection with the reservoir unit. In the embodiment shown, the pointed end of the needle can be moved between the initial position in which the pointed end is retracted relative to the mounting surface and the unsupported extended use.

position in which the pointed end protrudes from the mounting surface. In addition, the needle can be moved between the extended position in which the pointed end extends relative to the mounting surface and the retracted position in which the pointed end is retracted relative to the mounting surface. The needle unit further includes activating means that the user can grip in the form of a first stripe 21 for moving the pointed end of the needle between the initial and second positions when the activating means are activated and the retraction means that the user can grip in the form of a second band 22 for moving the pointed end of the needle between the extended and retracted positions when the retraction means are activated. As can be seen, the second strip is initially covered by the first strip. The housing further includes user-actuatable plug-in connecting means 40 in the form of a pair of spring hook elements adapted to cooperate with corresponding socket-connecting means in the tank unit, through which the tank unit attached to the needle unit in

In the embodiment shown, it comprises a relatively stiff upper part 11 attached to a more flexible, viscous sheet element 12 having a lower, sticky surface constituting the surface se, the sticky surface being a protective sheet. Base element 13, adapted to hook into a suitable groove in the tank unit.

The reservoir unit 5 comprises a pre-filled reservoir with liquid medicine (e.g., insulin) and expelling means in the form of an electronically controlled pump for dispensing medication from the reservoir through a needle in a use situation. The tank unit is generally a situation the mounting base per delivered with the tear-off also includes a rigid flat bottom surface adapted to be mounted on the upper surface of the base and includes a protruding part 50 adapted to be placed in the respective recess of the housing 20, as well as socket connecting means 51 adapted to cooperate with respective hook components 31 of the needle unit. The protruding part provides an interface between the two units and includes a pump outlet and coupling means (not shown) to enable the pump to be started when both units are assembled. The bottom surface also has a window (invisible) enabling the user to visually control the contents of the tank.

The first step in the assembly procedure is to connect both units simply by sliding the reservoir unit into the needle unit holder (Fig. 2). When the hook elements properly grip the tank unit, a "clicking" sound is heard (Fig. 3), warning the user that both units have been properly connected. If desired, a visual or acoustic signal can also be generated. The user then removes the tear-off sheet 14 to expose the sticky surface (Fig. 4), after which the device can be attached to the user's skin surface, usually on the abdomen (Fig. 5). The drug infusion is started by gripping and pulling out the actuation strip 21 as indicated by the arrow, as a result of which the needle is inserted, after which the infusion is automatically started (Fig. 6). The needle insertion mechanism may be provided in a pretensioned state and then be released by the drive means or the needle insertion may be "driven" by the user. An acoustic signal ("beep") confirms that the device is working and the medicine is being introduced. The tank unit is preferably equipped with signaling and detection means to inform the user with an audible alarm in the case of e.g. obstruction, pump failure or depletion.

After leaving the device in place for the recommended period of use of the needle unit (e.g. 48 hours), or when the reservoir is empty or for other reasons, it is removed from the skin by gripping (Fig. 7) and pulling (Fig. 8) the retraction strap 22, as indicated by the arrows, which leads to withdrawal of the needle, followed by automatic stopping of the drug infusion, and the strip that is attached to the sticky patch is used to remove the device from the skin surface (Fig. 9).

When the device is removed, both units are disconnected by pressing the two hook elements 31 as shown by the arrows (Fig. 10), allowing the reservoir unit 5 to slide out of the handle of the needle unit 2 as shown by the arrow (Fig. 11), after which the needle unit can be thrown out. Then, the reservoir unit can be reused with a new needle unit until it is emptied.

The reservoir unit may be provided at a constant basal infusion rate, or may be provided as an adjustable unit (Fig. 12), with regulating means 55 enabling the infusion rate to be set by a physician and / or by a user / patient. The tank unit may also be equipped with means for programming or setting electronic means of the control means (not shown).

The device described with reference to Figures 1-11 can also be used in other ways. For example, the needle unit can be mounted on the skin, after which the reservoir is attached. Depending on the configuration of the needle unit, it may or may not be possible to insert the needle before attaching the reservoir.

Fig. Dismantled

Fig. 13 shows another embodiment of the medical device 500, substantially corresponding to the embodiment of Fig. 1, the device comprising a needle unit 502 in the form of a lobe and a reservoir unit 505 attached thereto.

is a perspective view of the needle unit assembly comprising an upper housing portion 510, a needle carrier 520 and an infusion needle 530 attached to it, a drive element 540, a release element 550, a lower housing part 560 and a sheet element 570. The drive element includes a portion 541 that can be gripped the user and the needle driving portion 542, and the release member includes a portion 551 that can be gripped by the user and the withdrawal portion 552. Assembled, as shown in Fig. 15, the upper and lower housing parts form a housing 503 in which the needle and needle carrier are mounted, the drive and release members are operably connected to the needle carrier, wherein the parts gripped by the user are located outside the housing. In contrast to the embodiment of Fig. 1, the needle unit does not include a base plate, and instead, two beam elements 561 protruding from the housing, the beam elements and the bottom surface of the housing being mounted on a flexible sheet element which is provided on its bottom surface with a bottom sticky layer 571, which allows the needle unit to be attached to the patient's skin. The sheet member further includes an aperture 572 opposed to a lower projection 565 formed around the exit opening for the transcutaneous device, and the sheet is provided with a large number of small perforations to improve air permeability through the sheet. Housing 503 is provided with user-actuated connecting means 511 to attach to and detach the reservoir unit from the needle unit 505, the reservoir unit having corresponding matching coupling means 506, as well as a display 587. The display may indicate, e.g., proper unit operation, quantity medication in the tank or various indications of malfunction.

As can be seen, the user portion 551 gripped in the release element is initially covered by a portion of the activating element, thereby reducing the likelihood that the user will misuse the release element instead of the activating element. In addition, the activating and releasing elements (or parts thereof) can be color coded to further assist the user in proper use of the device. For example, the activation element may be green, symbolizing "start", while the release element may be red, symbolizing "stop".

Fig. 16 shows a perspective view of the needle carrier 520 with the needle 530 and the activation portion 542 of the activation needle 540. The activation portion of the needle includes two brackets 543 to allow it to slide relative to the housing, the brackets being positioned in respective housing holes 563. The needle carrier is adapted to be connected to the hinge element 562 of the lower housing to allow the needle carrier and thus the needle to pivot relative to the axis of rotation formed by the hinge. In the embodiment shown, the needle carrier is in the form of an element from a bent metal sheet, the carrier comprising an upper arm 521 and a lower arm 522, connected to each other by a hinge part 523, allowing the lower arm to tilt relative to the upper arm and relative to the axis of rotation. The lower arm forms a tray in which the recessed 530 infusion needle is mounted (e.g. by welding or gluing), the needle having a distal, pointed portion 531 adapted to penetrate the patient's skin, the distal portion extending generally perpendicular to the mounting surface of the needle unit and the proximal portion 532, located substantially around the axis of rotation and adapted to be connected to the source fluid. Thus, when a portion of the upper arm is mounted in the housing, the lower arm may tilt between the first, retracted, position in which the distal end of the needle is retracted into the housing, and the second, extended position, in which the distal end projects relative to the surface assembly. In the embodiment shown, the needle carrier provides activation means for moving the lower arm between both positions. This can be, as in the present embodiment, provided by the elastic properties of the sheet material per se, corresponding to the hinge part, or alternatively, an additional spring between the arms can be provided to push one away from the other. In order to lock the lower arm in the stimulated, unloadable, first position, the upper arm is equipped with a flexible release arm 526, including a catch 527, supporting and blocking the lower arm in its first, pressing this down, the position as well as the part release 528 cooperating with the inclined surface 544 of the activation part 542 of the needle, the hook further comprising a part 529 with an inclined edge adapted to engage with the lower arm, when it is moved from its extended to the retracted position, as will be described in more detail below.

To actuate the needle drive, the user grips the elastic strap forming part 541 that the user can grip (which preferably contains sticky parts to hold it in the shown initial bent position) and pulls the needle drive part 542 out of the housing in as a result, the activation element 540 completely separates from the housing.

In particular, when the inclined surface 544 is moved, it moves the hook 527 away from the lower arm to release it, after which the release part 528 detaches from the ramp, allowing both brackets to be pulled out of the housing. As can be seen in Fig. 17, when the activation element is removed, the release element portion 551 that the user can grip is exposed. As with the activation element, the portion of the release element that the user can grip preferably contains sticky parts to keep it in the shown initial bent position.

In the embodiment shown, the release element is in the form of a strip made of flexible material and has an inner end and an outer end, the strip being drawn through an opening 512 in the housing, as a result of which the strip forms a part 551 that can be gripped by the user and part 552 , retracting the needle, the inner end of the strip being attached to the housing and the outer end of the strip being attached to the peripheral portion of the sheet member 570, or, alternatively, peripheral part of the housing. In the view shown in Fig. 18, the release element is shown in the initial position, the retraction part forming a loop 555 located below the lower arm of the needle carrier; this position allows the lower arm to move to its energized position, and therefore the needle to its extended position.

When the user decides to remove the needle unit from the skin, he grips the portion 551 that the user can grip, lifts it from the housing and pulls it up, as a result of which the loop shortens, moving the lower arm up; this item corresponds to the intermediate release state. As a result of this action, the lower arm engages on the inclined edge 529 of the catch 527, sliding it outwards until it snaps under the lower arm again according to the position shown in Fig. 16. Because the activation element 540 has been removed from the needle unit, the needle carrier is irreversibly locked in the retracted position. As the user continues to pull the release element, the peripheral portion of the sheet element to which the release element is attached will be lifted from the skin, as a result of which the needle unit with the reservoir unit attached thereto may be removed from the skin as shown and described with reference to Figures 7 - 9.

Advantageously, the activation and release elements can be formed and placed so that they communicate with the reservoir unit (not shown). For example, one of the activation element brackets may protrude through the housing in the initial position to interact with the appropriate connector in the reservoir unit, which signals the reservoir unit that the needle unit has been attached, while removal of the activation element will indicate that the needle has been inserted, and therefore that a medicine infusion can be started. Accordingly, actuation of the release member may be used to stop the pump.

In Fig. 19 the side of the needle unit 502 is shown, which is connected to the reservoir unit. In addition to the two beam members 561 and the user-actuated connecting means 511, the needle unit includes other structures that connect to and / or hook the reservoir unit to provide a functional interface with the reservoir unit. In particular, the needle unit includes a fluid inlet provided by a pointed proximal portion 532 of the needle protruding from the needle unit and adapted to cooperate with the fluid outlet of the reservoir unit, an activator 515 protruding from the needle unit and adapted to hook and activate a flow connector in the reservoir unit ( see the rest of the description) and activators of the first connector 548 and second 558, adapted to cooperate with the corresponding connectors of the tank unit. The first connector activator is provided by the distal end of one of the needle activator brackets 543 protruding through the opening in the housing, and the second connector activator is provided by the hinged portion of the housing connected to the needle retraction portion 552 in the release element 550. When the needle unit is first connected to the reservoir unit, both connector activators protrude from the housing and interact with the corresponding connectors in the reservoir unit, thus signaling that the needle unit has been attached. When the needle is activated, the first connector activator is retracted and thus disconnects from the corresponding connector in the reservoir unit to start the pump. When the needle is withdrawn, the second connector activator is tilted and disconnects the corresponding connector in the reservoir unit to stop the pump.

Fig. 20 shows the tank unit with the upper housing part removed. The reservoir unit includes reservoir 760 and expedition assembly, including pump assembly 300 and means for controlling it 580 and starting 581. The pump assembly includes outlet 322 for connecting to a transcutaneous access device (e.g. needle 530) and opening 323 to enable activation internal flow connector, see the description continues. The reservoir 560 is in the form of a pre-filled, flexible and foldable bag, containing a needle-permeable septum adapted to form a fluid connection with the pump assembly, see the following description. The pump assembly shown is a mechanically actuated diaphragm pump, however the reservoir and expelling means may be of any suitable configuration, e.g. as described with reference to Fig. 25A.

The means for controlling and activating include a pump activating element in the form of a coil activator 581 adapted to actuate a diaphragm pump piston, a rigid or flexible printed circuit to which a 583 microprocessor is attached to control, among others, the activation of the pump, connectors 588, 589, needle units cooperating with connector activators, means generating 585 signals, used to generate acoustic and / or sensor signals, display (not shown) and energy source 586. The connectors are preferably protected by membranes that can be formed by flexible housing parts.

Fig. 21 is an exploded view of the reservoir unit 505 of Fig. 13, the unit comprising an upper housing element 507, a lower housing element 508 with a transparent area 509, and grooves 504 for receiving beam elements 561 protruding from the needle unit, a flexible tank 760 with a rounded edge portion 762 on which it is mounted baffle element 761, pump assembly 300 with activator and electrical circuit board (not shown) located above the reservoir and containing electronic components to control pump activation. The upper and lower housing components include tank mounting means in the form of upper and lower beam portions 780 opposite each other (the bottom one is not visible), adapted to grip and mount the tank in the housing. Each beam part has a central cut-out part 781 adapted to grip the partition element by opposite surfaces when the housing elements are joined, thus immobilizing the tank inside the housing. The degree of immobilization is determined by the pressure k exerted on the partition element, the elastic properties of the partition element and the friction between the beam and the partition element. On each side of the cutout, the beam parts contain a straight part 782, a tank, a property that can help you mount the tank in the housing. Straight parts may grab the initially filled tank to hold it in place, however, when the tank is empty and flattened, its handle may be weaker. On the contrary, interaction with the partition is adapted to hold the tank properly when the tank is emptied. Straight parts can also be adapted to squeeze and flatten to the end of the tank, serving as additional fastening means. Additional attachment means (not shown) may grip the tank at other locations, e.g. along welded edges 765.

Fig. 22A shows a diagram of the pump connected to wherein the pump has the following general flow connection 391 with reservoir 390, safety valve 392, inlet and outlet valves 393, pump chamber 395 with associated piston 396 and outlet 397. Arrows indicate the direction of flow between individual components. When the piston is moved down (in the figure), a relatively negative pressure is created inside the pump chamber, which opens the inlet valve and then draws fluid from the reservoir through the open primary side of the safety valve. When the piston is moved up (in the figure), a relative overpressure is created in the pump chamber, which closes the inlet valve and opens the outlet valve and safety valve, as a result of which fluid flows from the pump chamber through the outlet valve and the secondary side of the safety valve to the outlet . As can be seen, in normal operation, the safety valve allows fluid to flow during both fluid pickup and delivery, and is therefore "passive" during normal operation. However, if the tank pressure increases (which can happen with a flexible tank), the increased tank pressure will be transferred to both the primary side of the safety valve and, through the pump chamber, to the secondary side of the safety valve and, as a result, the pressure from the original side the safety valve will not allow the secondary side to open.

Fig. 22B is an exploded view of the pump assembly 300 using the principle of operation of the pump shown in Fig. 22A, wherein the pump assembly (hereinafter also referred to as the pump) is suitable for use with the tank units of Fig. 1 - 13. The pump is a diaphragm pump containing a piston activated diaphragm with flow control inlet and outlet valves. The pump generally has a layered structure including first elements 301, second 302 and third 303 between which the first and second membrane layers 311 and 312 are located, the pump chamber 341 being formed by first and second elements in combination with the first membrane layer, a safety valve 345 is formed by the first and third elements in combination with the first membrane layer, and inlet valves 342 and outlet 343 are formed by second and third elements in combination with the second membrane layer (see Fig. 22C). The layers are held in stack configuration by an outer clamp 310. The pump further includes an inlet 321 and an outlet 322, as well as a connector opening 323, all three being covered with appropriate membranes 331, 332, 333, sealing the inside of the pump in its initial sterile condition. Membranes can be penetrated or interrupted (e.g. can be made of paper) through a needle or other element introduced by a given seal. The outlet further includes a self-sealing, needle-permeable septum 334 (e.g., material with rubber properties) so that the pump can be connected to the outlet needle. As shown in Fig. 22C, a fluid path (indicated by a dark line) is created between the inlet 321 (see further part of the description) and the inlet valve 342 through the primary side of the safety valve 345, between the inlet valve, pump chamber 345 and outlet valve 343, and between the outlet valve and outlet 322 through the secondary side of the safety valve; a fluid path is formed in or between different layers. The pump also includes a piston 340 for activating the pump membrane, the piston being driven by external drive means (not shown).

The pump further includes a flow connector in the form of a cavity connecting needle 350 disposed slidably in the needle chamber 360 located behind the connector opening, see Fig. 22D. The needle chamber is formed by pump layers and includes an internal sealing septum 315 into which the needle is inserted, the septum being formed by the first membrane layer. The needle has a pointed distal end 351, a proximal end at which the needle piston 352 and a proximal opening 353 are located, in fluid communication with the distal end, the needle and piston being displaced with respect to the inner septum and chamber. As can be seen in Fig. 22D, the needle piston in its initial position is bypassed by one or more radially arranged grooves 359. They are made to allow steam sterilization and to ventilate air that would otherwise be trapped when the fluid connector is moved forward in the needle chamber.

The pump assembly described above may be equipped with a drug delivery device, shown in Fig. 1 20. In a situation of use, when the reservoir unit is attached to the needle unit, the proximal end 532 of the infusion needle is introduced through the outlet seal and the septum 334 of the pump and activator 515 ( see Fig. 19) is introduced through the coupling membrane 333. As a result, the needle is pushed from its initial position shown in Fig. 22D into the active position shown in Fig. 22E, in the infusion, shown)), not to be an infusion device whose distal end is introduced through the inlet membrane 331 and then through the needle-permeable septum in the adjacent reservoir, resulting in a flow path between the reservoir and the inlet valve through the proximal opening 353 in needle. In this position, a seal is formed between the needle piston and the needle chamber.

As can be seen, when both units are disconnected, the proximal end 532 of the infusion needle is extended from the pump outlet, while the connecting needle constantly provides a flow connection between the pump and the reservoir.

In the above-described embodiments, the transcutaneous device is in the form of a single needle (e.g., a needle as shown, or needle sensor, however, the transcutaneous device may also be in the form of a cannula or sensor in combination with an insertion needle that is retracted after insertion of the cannula For example, the first part of the needle may be in the form of a (relatively soft) infusion cannula (e.g., Teflon® cannula) terminated with a removable insertion needle. This type of cannula needle system is well known for so-called infusion sets, which are usually used to form an infusion site in combination with (fixed) infusion pumps.

Thus, Figs. 23A and 23B show in a schematic representation how the combination of cannula and insertion needle may be positioned within housing 601 in a given medical device 600 (shown partially), e.g., an infusion device or kit. In particular, the medical contains a transcutaneous syndrome 650, comprising a combination of a relatively soft 651 cannula (which, e.g., may be of the soft "Teflon type^®"), Supported by the lower element 653 and the pointed insertion needle 661 (e.g. made of stainless steel, medical grade), slidably positioned inside the cannula and supported by the upper element 663, both elements mounted so that the axial cannula is displaced relative to the insertion needle. The cannula has a proximal inlet (not shown) so that it is or can be in fluid communication with a fluid source. The medical device further includes a base plate 620 with a cannula hole 621, as well as a release member 622. The bottom member includes an elastomeric seal 652 in which the insertion needle is located. The cannula and insertion needle may be straight or bent, depending on how both components are mounted in the device, e.g. arcuate according to the tilting axis or straight according to the linear movement as shown. The upper element includes a connecting element 667 securing the elements one to the other in the initial position with the distal end of the insertion needle protruding from the distal opening of the cannula, as shown in Fig. 23A, wherein the base plate includes a coupling element 657 for locking the lower element in the extended position with the distal end of the cannula extended through the hole in the base plate (see Fig. 23B). A first spring 668 is located between the housing of the device and the upper element, pushing the upper element upwards.

Accordingly, the device also includes a second spring 658, pushing the bottom element up. The medical device further includes a plate holder 676 and a pull member 677, according to the embodiment shown in Fig. 1.

In a use situation, the assembly is moved down, either manually, or by a releasing insertion aid, e.g. a spring-driven element acting through an opening in the housing (not shown), the cannula with the protruding insertion needle being inserted through the patient's skin . In this position, the lower element grips the coupling element 657 to lock the cannula in its extended position when the coupling element 667 is released by the release element 622, thus allowing the upper element to return to its initial position due to the first spring.

When the user wants to remove the delivery device from the skin surface, the user grips the gripped portion of the plate and pulls it in the first direction, substantially parallel to the skin surface, as a result of which the elastic strap 677 releases the coupling element 657 from the lower element, resulting in the lower element, and therefore, the cannula is retracted with a second spring. After the cannula is withdrawn from the skin, the user now uses the bent plate to pull the entire delivery device from the skin surface, for example by pulling the plate away from the skin surface.

Fig. 24 shows an embodiment of a device adapted to the assembly procedure described with reference to Figs. 1-12 (i.e. assembly of the needle unit first).

In particular, Fig. 24 shows a perspective view of a medical device in the form of a drug delivery device 100, including a needle housing 110, a base member 130 with a lower mounting surface 133 adapted to be applied to the patient's skin and a separate pump unit 150. In the embodiment shown, the base element comprises a relatively stiff upper part 131, attached to a more flexible, adhesive flap element 132, having a lower adhesive surface, providing the mounting surface per se. The needle housing can be formed integrally with the base element, or attached to it as a separate unit, the two elements together forming a platform unit. In the embodiment shown, the needle unit includes a housing 111, inside which the cavity needle 112 is hinged.

The housing includes first and second openings (or windows), covered by first and second covers. In the embodiment shown, the first sheath is in the form of a needle permeable rubber membrane 121, and the second sheath is in the form of a tear paper that allows components to be introduced into the housing. The paper sheet is permeable to sterilizing gases, while the paper sheet, rubber membrane and housing together provide a sterility barrier for the closed needle.

The needle includes a first needle part 113 having a first pointed end adapted to penetrate the skin of the patient, the first needle part running generally perpendicular to the mounting surface and the second needle part 114, in fluid communication with the first needle part through the intermediate needle part 115 and having a second pointed finally, the second part of the needle is located substantially parallel to the mounting surface. The needle is connected to the housing by means of a mounting element 117 that allows the needle to be tilted relative to the axis formed by the second needle part, wherein the needle can be moved between the initial sterile position in which the first part of the needle is retracted relative to the mounting surface and the second a position in which the pointed end of the first needle portion projects through the rubber septum and relative to the mounting surface. The housing also includes a pushing element 118 that pushes the needle towards the initial position. Often, the part of the needle "downstream" (here: the first part) is called the distal part, and the part of the needle "upstream" (here: the second part) is called the proximal part.

The tank (or pump) unit 150 comprises a housing in which the tank and expelling means are located.

The reservoir is adapted to store liquid medicine (e.g., is pre-filled or adapted for filling by the user) and includes outlet means in the form of a protruding septum 155 that can pierce the needle, adapted to form a fluid connection with the second part of the needle. Expediting agents (not shown) are adapted when used to expel medication from the reservoir and through the patient's skin through a cavity needle. The pump unit further includes an inclined element 156, located next to the outlet of the tank. The reservoir and expelling means may be of any suitable configuration according to the invention, e.g. as described with reference to Fig. 25A.

The mounting platform includes a fastening portion, the fastening portion and the pump unit comprising matched connecting portions 160 enabling the pump unit to be attached to the platform unit. Matching connecting parts can be detachable, allowing multiple attachment of a fixed or reusable pump unit to a disposable platform unit.

In a use situation, the platform unit is mounted on the user's skin (e.g., by means of adhesive means located on the mounting surface) and the pump unit is attached and attached to the platform unit by sliding it into the holder essentially parallel to the mounting surface. During this operation, the protruding septum and the sloping element are moved to contact the needle, as a result of which the paper sheath 122 is broken and the fluid connection between the second needle part and the reservoir is established when the needle is tilted from the initial to the second position, the first pointed the tip of the needle pierces the rubber membrane and the user's skin.

After connecting the pump unit and inserting a needle under the skin, the pump can be started. This can happen automatically after joining both units, or with the help of inside

Also, separate, user-actuated actuators, e.g., a start button (not shown).

In an alternative embodiment (not shown), the second needle portion may be permanently (i.e., non-rotatable) attached to the fastener 117, and the intermediate needle portion 115 is flexibly bent when pressed down by the slanted portion 156. In this arrangement, the push member 118 may be removed.

In the above-described embodiments, a delivery device has been described comprising a flexible reservoir in combination with an example of expelling means. However, the tank and expediting means may be of any type that is suitable for placing a skin-mounted delivery device.

since the needle may also be in the form of a needle sensor, the interior of the medical device may include sensor means adapted to cooperate with the needle sensor.

Fig. 25A schematically shows an example of expediting agents suitable for use with the present invention, however, this is only an example, like the arrangement of individual components shown, is not necessarily suitable for direct use in the delivery device shown above. In particular, 25A shows a pump arrangement, including a medication capsule 1010, forming a reservoir and having a distal closing member 1011 for connecting a needle and piston 1015, slidably positioned inside the capsule, a flexible, toothed piston rod 1020 (e.g., as described in US Patent 6,302,869), an electric motor 1030, which drives a piston rod through a transmission system 1031 to expel medication from the capsule, the engine being controlled by means of control means 1040, and the energy for the control means and the engine is supplied by a 1050 battery. The pump can be started when the needle is inserted (using means not shown) or by means of separate, user-activated means (not shown), after disconnecting the introduction device from the delivery device .

In Figs. 25B-25D examples of expediting agents are shown which do not form part of the claimed invention but can be considered as alternative solutions.

FIG. 25B shows a pump system, comprising a drug capsule 1110, having distal closing 1111 and proximal 1112 and piston 1115, slidably disposed within the capsule, gas generating means 1120, in fluid communication with the interior of the capsule via conduit 1121 to drive the piston to expel the medicine from the capsule, the gas generating means being controlled by control means 1140, and the energy for the control means and for gas generation is provided by a 1150 battery. The pump can be started as indicated above. A detailed description of such gas generating means for a drug delivery device can be found, e.g., in US Patent 5,858,001.

FIG. 25C shows a pump system comprising a medicine capsule 1210 having distal closing devices 1211 and proximal 1212 and a piston 1215 slidably positioned inside the capsule, an osmotic engine 1220 in fluid communication with the interior of the capsule through conduit 1221 to drive the piston to expel the medicine from the osmotic the first rigid containing salt solution and the second folding tank 1226 containing water, both tanks are separated by a semi-permeable membrane 1227. In the condition delivered to the user, the flow connection 1228 between the second tank and the membrane is closed by a membrane, damaged by the user (e.g. weak welding), capsules. Tank engine 1225, which, when destroyed, allows the osmotic process to begin when water is drawn from the second tank through the membrane into the first tank. The pump can be started as mentioned above. A detailed description of the principle of the osmotic drive can be found e.g. in a patent

USA 5,169,390.

Fig. 25D shows a pump system comprising a medicament flexible reservoir 1310 disposed within a rigid, liquid filled secondary reservoir 1311 in fluid communication with the main reservoir 1320 through a conduit 1330 containing a flow restrictor 1331. The primary reservoir is in the form of a capsule with a movable piston 1321 and contains viscous propellant. The spring 1340 is adapted to act on the piston to push fluid out of the first into the second reservoir, thereby dispensing the medicine from the flexible reservoir when it is connected to the infusion needle (not shown). The flow rate is determined by the pressure generated by the spring in the propulsion fluid, the viscosity of the propulsion fluid and the flow resistance in the flow restrictor (closed-hole principle). The pump can be started by spring tension or by releasing the preloaded spring, or when the needle is inserted (by means that are not shown), separate means, actuated by means (not shown), when the delivery device is disconnected from the delivery device. An example of this principle of operation used for infusing medications is known from DE 25 52 446. In an alternative configuration, the drug reservoir can be pressed directly to expel the drug through the flow restrictor, e.g., as described in US Patent 6,074,369.

In Fig. 26 a medical device 900 is shown, corresponding to the embodiment of Figs. 1-11, however, the reservoir unit has a modular structure comprising either a "durable" control unit 910 for the user, adapted to be mounted on the reservoir unit 920, comprising the reservoir and assembly expeditor, controlled by the control unit via connector 921. The transcutaneous device unit 930 may be the same as in Figs. 1-11. The transcutaneous device unit and the reservoir unit include matched connection means (931) to attach the reservoir unit to the percutaneous device unit to create a fluid connection between the reservoir and the percutaneous device and the control unit and reservoir unit comprise matched connecting means ( 917, 921), enabling the control unit to be attached to the tank unit to control the expedition assembly. The control unit may include one or more of the following functions: oscillator, RF transmitter, RF receiver, display, 918 button (as shown) or other user actuated means, power supply battery, memory. In addition, the control unit may be adapted to provide a constant flow rate or it may be programmed (e.g. by remote control) to provide a constant rate or a specific profile. Different control units can also be used with different reservoir units (e.g., containing different drugs or different amounts of drug) or with different needle units (e.g., containing a needle or soft cannula). As stated above, the controller may be used by the user as a fixed device, however (simpler) versions of the controller may be provided with the reservoir unit and may be used as means of providing various types of disposable devices.

Fig. 27 shows a modular system comprising a number of different types of control units in addition to the basic needle bladder unit 930 and the basic reservoir unit 920. Remote controller 940 can be used in combination with some of the control units. The control unit may be in the form of a remote-controlled unit 911, which can only be controlled by a remote controller. In version 912 it may also contain a button that allows the user to take a dose of the drug without the need for a remote controller. The control unit may be provided as various pre-programmed control units 913, each providing a constant flow rate as indicated on the unit. Such a unit is intended for use without a remote controller and may include a 919 display as shown. A programmable control unit 914 may also be provided, enabling e.g. an operator to program the control unit for a given patient. The symbol 915 represents any of the control units described in combination with the reservoir unit and the needle unit.

In the above description of preferred embodiments, various designs and means providing the described functionalities for the various components have been described to the extent that the concept of the present invention should be apparent to those skilled in the art. The detailed design and specifications of the various components are considered to be the subject of a normal design procedure carried out by a specialist based on the directions contained in this description.

NOVO NORDISK A / S

Proxy:

78P25772PL00

EP 1 682 203 B1