HK1258971B - Medical delivery device - Google Patents

Description

Medical delivery equipment

Technical Field

The present invention relates to a medical delivery device according to the preamble of independent claim 1. Such a device may be embodied by the following components: (i) a rod element having a stem portion comprising a longitudinal axis, a first threaded arrangement, a proximal end portion and a distal end portion; (ii) a dial housing having a second threaded arrangement; and (iii) a delivery orifice arranged adjacent the proximal end portion of the rod element. In a metered delivery state of the medical delivery device, the first threaded arrangement of the rod element engages with the second threaded arrangement of the dial housing. The rod element can be moved relative to the delivery orifice along the longitudinal axis of its stem portion by rotating the dial housing around the stem portion, thereby causing the first threaded arrangement of the rod element and the second threaded arrangement of the dial housing to move along each other, wherein a dosage chamber is formed between the rod element and the delivery orifice when the rod element moves away from the delivery orifice. This type of device may be used by a patient to self-administer a liquid such as a medicine or a drug.

Background Art

In many medical applications, liquids or other fluids need to be transferred from containers, and this can be done in a variety of ways. In particular, when liquids must be delivered with considerable precision, specialized devices are often used. For example, liquid medications are often provided in glass or plastic vials or containers that are sealed with a septum or rubber stopper and a metal cap or other similar sealing cover clamped around the septum or rubber stopper.

Typically, a syringe is used to deliver medication from a vial. Thus, a needle attached to the syringe penetrates a septum or cap and the medication is extracted into the syringe through the needle. Once transferred into the syringe, the medication can be delivered in a suitable manner. For example, the medication can be injected into the patient's body, such as percutaneously or intramuscularly, through the needle, or it can be administered orally or as drops into, for example, the patient's eyes or nose.

Transferring liquids from vials or containers using a syringe is often difficult. This often necessitates the involvement of trained personnel, such as doctors or nurses. In particular, when precise dosages of liquids must be delivered, such as when relatively small volumes, such as in the range of 10 microliters to about 1 milliliter, are involved, patients are often unable to perform the delivery themselves using conventional syringes or similar devices, i.e., cannot self-administer the medication. However, self-administration of liquids or medications is beneficial in many therapeutic applications because it can significantly reduce patient effort and treatment costs.

To improve this situation, devices that allow for more convenient delivery of relatively precise volumes of liquids have been developed. For example, it is known to provide medications in prefilled syringes that can be self-administered by the patient. However, these prefilled syringes are generally not preferred for a variety of reasons. For example, producing prefilled syringes is more complex and expensive than producing vials. Another example of a delivery device is the injection pen commonly used to treat diabetes.

Furthermore, US Pat. No. 6,607,508 B2 describes an automatic drug delivery device comprising a cylindrical syringe barrel into which a plunger rod extends from one side. The other side of the syringe barrel is provided with threads onto which a needle assembly can be screwed. The plunger rod has a vial holder into which a vial can be inserted. The plunger rod is also provided with a channel extending longitudinally through the entire plunger rod. A pin extends radially from the plunger rod and engages with a groove in the dose barrel surrounding the pin-bearing section of the plunger rod. By rotating the dose barrel via a dose ring, the plunger rod translates and forms a volume between the plunger rod and the threaded side of the syringe barrel. This movement causes drug to be transferred from the vial through the channel into the volume. A ratchet mechanism prevents reverse rotation of the dose barrel, ensuring that the liquid is not forced back through the channel. The device also comprises a spring-driven automatic needle injection device for delivering drug from the volume via a needle screwed onto the threads of the syringe barrel. During drug delivery, the plunger rod automatically rotates in the opposite direction due to the spring force and the volume is reduced. As a result, the drug is pressed out through the needle.

Even though these known conveying devices improve the situation with respect to easy operation and feasibility of self-administration, they are more complicated for being particularly used for accurate metering and for delivering liquid after metering. In addition, when using rotatable metering or conveying devices, the conveying of liquid can be quite slow, which makes the administration more loaded down with trivial details.

Therefore, there is a need for a medical delivery device which, on the one hand, allows for accurate metering of liquids from a container and, on the other hand, allows for convenient metered supply and self-administration of liquids.

Summary of the Invention

According to the invention, this need is solved by a medical delivery device as defined by the features of independent claim 1. Preferred embodiments are subject matter of the dependent claims.

Specifically, the present invention relates to a medical delivery device comprising a rod element, a dial housing, a delivery orifice, and an optional housing. The housing has an interior space, a proximal opening, and a distal opening. The rod element optionally extends into the interior space of the housing. The rod element has a stem portion comprising a longitudinal axis, a first threaded arrangement, a proximal end, and a distal end. The dial housing optionally extends into the interior space of the housing and has a second threaded arrangement. The delivery orifice is disposed adjacent to the proximal end of the stem portion of the rod element. In a metered delivery mode of the medical delivery device, the first threaded arrangement of the rod element engages with the second threaded arrangement of the dial housing. Furthermore, in the metered delivery mode of the medical delivery device, the rod element can be moved relative to the delivery orifice along the longitudinal axis of its stem portion by rotating the dial housing about the stem portion, causing the first threaded arrangement of the rod element and the second threaded arrangement of the dial housing to move along one another. Optionally, a dosage chamber is formed in the interior space of the housing between the rod element and the delivery orifice, the dosage chamber increasing in size as the rod element moves away from the delivery orifice.

The medical delivery device also includes a switching mechanism for switching the medical delivery device from a metering state to a delivery state. In the metering state of the medical delivery device, the rod element is prevented from moving along the longitudinal axis of its stem by applying an axial force to the rod element. In the delivery state of the medical delivery device, the rod element can be moved relative to the delivery orifice along the longitudinal axis of its stem by applying an axial force to the rod element, and can be prevented from moving along the longitudinal axis of its stem by rotating the dial housing about the stem of the rod element.

The term "proximal," as used in conjunction with the present invention and its disclosed embodiments, may refer to the orientation of a medical delivery device that points toward a patient's body during its intended use. Thus, when the medical delivery device is applied to a patient, the proximal portion or component may be directed or positioned closer to the patient's body. Conversely, the term "distal," as used in conjunction with the present invention and its disclosed embodiments, may refer to the orientation of a medical delivery device that points away from the patient's body during its intended use. For example, in a conventional syringe, the proximal end is typically the tip of the needle, and the distal end is the end of the plunger where the thumb rests.

The term "thread" as used herein refers to male/convex structures such as ridges or female/concave structures such as grooves that extend along and around a surface or body. Typically, a thread is helical or substantially helical in shape and extends along and around a body or portion.

The optional housing can be more or less cylindrical. It can also include a cap, such as a needle shield. The distal and proximal openings can be embodied on the respective distal and proximal sides of the housing. It can have a flange portion at or near its distal end, serving as a finger rest, in which the distal opening is disposed. The housing can, in particular, form an outer envelope for the medical delivery device. It can be shaped to allow for convenient handling and use of the device and to protect components within its interior space.

The term "extending into" in connection with lever elements, dial housings, casings and other components may refer to being arranged completely or partially inside. For example, it may refer to an arrangement in which a portion of one component is partially located outside another component but protrudes into the other component.

The first threaded device may be an external threaded device, and correspondingly, the second threaded device may be an internal threaded device. The term "external" in conjunction with a threaded device may refer to the direction in which the threaded device is oriented. In particular, it may refer to the threaded device being oriented outward so that it can interact with a corresponding internal threaded device. Similarly, the term "internal" in conjunction with a threaded device may refer to the opposite direction in which the threaded device is oriented.

The stem of the rod element can have the shape of a pillar or a cylinder.While extending into the interior space of the housing, the distal end of the body of the rod element can be located near the distal end of the housing and the proximal end of the stem of the rod element can be located near the proximal end of the housing.

The dial housing can be arranged at least partially around the rod element or around the section thereof in which the first threaded device is located. It can be embodied as a hollow cylinder or it can include one or more cylinder segments that can together form a hollow cylinder. In particular, it can consist of two substantially semi-cylindrical walls or a clamshell.

The housing and the lever element can be rotated relative to each other by the dial housing rotating around the lever element, the lever element rotating in the dial housing, or both the dial housing and the lever element rotating. For efficient and appropriate rotational movement, the dial housing and the lever element can be coaxially arranged.

The term "travel along one another" used in conjunction with first and second threaded devices may relate to the movement or displacement of components in or on the threads. For example, a male component such as a pin may move along a groove in a female thread.

The delivery orifice can be shaped for a specific application or the delivery of a drug to be delivered from the device. For example, if the device is intended for injectable medication, it can be a needle. In such an embodiment, the delivery orifice or needle can extend from the interior space of the housing through its proximal opening, out of the housing or a specific portion thereof. The delivery orifice can also be adapted to connect to a delivery component. For example, it can comprise the male or female portion of a Luer lock or Luer taper connector, and the delivery component can be equipped with a corresponding female or male Luer lock connector. Other examples of delivery orifices are nozzles, valves, fluid guides, and the like.

The term "axial force" used in conjunction with moving a rod element may refer to a force applied to the rod element to axially move it when the medical delivery device is in a delivery state. Typically, such an axial force is manually induced, for example, by pressing with a thumb on the distal end of the rod element, on a container mounted on the rod element, or on another part connected to the rod element.

In this context, the term "preventing" can refer to hindering an axial force from axially moving the rod element. It will be appreciated that if the axial force is high enough, the rod element may still be axially moved, for example by damaging certain parts of the device. Thus, preventing axial movement due to the axial force can be related to proper use of the device.

As used herein, the term "container" may refer to any liquid reservoir suitable for storing and transporting liquids. In the case where the liquid is a pharmaceutical, etc., the container may particularly be a medicine bottle. The term "medicine bottle" as used in this context may refer to a relatively small container or bottle, which is typically used to store a medicine or medicament or drug in liquid, powder or capsule form. The medicine bottle may be made of a sterilizable material such as glass or a plastic such as polypropylene.

The medical delivery device can be made of a plastic material. In particular, it can be made of a sterilizable plastic material that can be manufactured in an injection molding process.

By providing a switching mechanism for the medical delivery device, a clear distinction can be made between a metering state and a delivery state during use. This allows for the functional separation of metering of liquids, such as medications, from the delivery of the liquid. Typically, in a first step, the medical delivery device is in the metering state. In this state, the liquid can be precisely metered into the dosing chamber by rotating the metering housing. This prevents inadvertent actuation of the medical delivery device, for example by applying an axial force to a rod element, which would reduce metering accuracy. This facilitates accurate and safe metering of liquids and ensures that liquid is not delivered before metering is complete.

After the medical delivery device is switched to the delivery state, further metering is prevented, which prevents the precise delivery of the liquid from being compromised. Furthermore, in the delivery state, actuation of the medical delivery device can be particularly convenient, as further metering is not possible and, therefore, no measures need to be taken to prevent inadvertent changes in the dose during administration. This makes self-administration of liquids particularly convenient and safe. Furthermore, since linear or axial actuation is possible, delivery can be relatively fast. A switching mechanism can be employed that prevents switching the medical delivery device back to the metering state once it is in the delivery state. Furthermore, the switching mechanism can be configured to be active or activated only after a predetermined volume has been metered or after the dial housing has been rotated a predetermined amount.

The medical delivery device according to the invention therefore allows, on the one hand, precise metered delivery of a liquid, for example from a container, and, on the other hand, convenient self-administration of the liquid after metered delivery.

Preferably, the switching mechanism includes a disengagement structure that disengages the first threaded arrangement of the rod element from the second threaded arrangement of the dial housing after the medical delivery device switches from the metering state to the delivery state. Disengagement of the first threaded arrangement from the second threaded arrangement is possible because the rod element moves axially without rotating about the longitudinal axis of its stem. Therefore, the rod element can be displaced by axial force without any rotational movement. This disengagement structure allows the rod element to be configured in a relatively simple manner, allowing axial movement by rotating the rod element in the metering state and pushing it in the delivery state. In this way, the medical delivery device can be effectively equipped with a feature that allows operation in two separate states or modes of operation.

Thus, the disengagement structure of the switching mechanism preferably includes a protrusion disposed on the first threaded device and a guide groove into which the protrusion extends. After the medical delivery device switches from a metering state to a delivery state, the guide groove moves and the protrusion travels along the guide groove to disengage the first threaded device from the second threaded device of the dial housing. The protrusion may extend in a generally axial direction. Together with the guide groove, the protrusion allows the first threaded device to effectively disengage from the second threaded device after the medical delivery device switches from a metering state to a delivery state. In particular, this arrangement allows for an efficient and relatively simple mechanical implementation of the switching mechanism.

Thus, the projection of the disengagement structure preferably extends axially, and the guide groove extends in a plane approximately perpendicular to the longitudinal axis of the stem of the lever element, wherein the guide groove is shaped such that, when the guide groove is rotated about the longitudinal axis of the stem of the lever element, the projection moves toward the longitudinal axis of the stem of the lever element. In this context, the term "axial extension" may refer to extension in the direction of or along the longitudinal axis of the stem of the lever element. By moving the first threaded device toward the longitudinal axis, it can be disengaged from the second threaded device. This allows the lever element to no longer be coupled to the dial housing. Consequently, the lever element can be moved axially under the action of an axial force, wherein rotating the dial housing no longer causes the lever element to move forward.

Preferably, the thread of the first threaded arrangement of the lever element or the thread of the second threaded arrangement of the dial housing is provided with a plurality of irregularities positioned at a fixed distance from one another, such that when the dial housing is rotated about the longitudinal axis of the lever element, the first threaded arrangement of the lever element and the second threaded arrangement of the dial housing engage at one of the plurality of irregularities at a predetermined rotation angle. Each time the first threaded arrangement or the second threaded arrangement is rotated a certain degree, the irregularities may cause an audible and/or tactile signal. For example, the irregularities may be gaps in the wall of the threads.

Thus, the irregularities are positioned such that rotating the dial housing about a predetermined rotational angle causes the dose chamber to change in volume by a predetermined amount. In particular, each rotation about the predetermined angle causes the volume of the dose chamber to change by the same predetermined amount. In this way, during metered delivery, a clear signal can be provided to the user of the medical delivery device indicating that the metered volume has changed by the predetermined amount.

Preferably, the rod element comprises a stopper on its proximal side. In particular, the stopper can be located on the proximal side of the stem of the rod element. The term "stopper" herein may relate to a stopper in the narrow sense, i.e., a plug-like sealing component. It may also relate to an alternative sealing component, such as an O-ring mounted on the stem. The stopper can be made of an elastic material such as rubber so as to provide tightness. With the aid of the stopper, the rod element can be tightly arranged in the corresponding barrel body. In this way, a low pressure, a partial vacuum or a vacuum can be induced in the dosage chamber, which allows the liquid to be extracted into the dosage chamber.

Preferably, the rod element includes a transfer channel extending through the stem along the longitudinal axis of the stem. The transfer channel may also extend further through the stopper. The transfer channel allows a connection to be established through the rod element, and in particular axially through the stem. It may be implemented as a transfer needle. In particular, a container arranged at or near the distal end of the rod element can be connected to the dosing chamber via the transfer channel. The transfer channel allows liquid to be transferred from the container via the rod element into the dosing chamber when the dial housing is rotated about the longitudinal axis. More specifically, by rotating the dial housing, the rod element moves along the longitudinal axis, causing the dosing chamber to expand or contract and liquid to be transferred from the container into the dosing chamber, or from the dosing chamber into the container.

Preferably, the medical delivery device comprises a container seat connected to the distal end of the stem of the rod element. Such a container seat allows the container to be connected in a well-defined position and orientation. This allows the container to be effectively coupled to the system.

Thus, the transfer channel preferably comprises a tip and an opening, wherein, in the metered delivery state of the medical delivery device, the tip and the opening protrude into the container seat so that they are located within the container when the container is arranged in the container seat. The transfer channel can be a transfer needle. The container can be closed by a penetrable cover such as a septum, a cap, etc. The transfer channel allows for an axial connection of the container to the rod element and a linear coupling with the dosing chamber, which allows for efficient implementation.

Thus, the transfer channel of the rod element is preferably closed after the medical delivery device changes from the metered supply state to the delivery state. The container seat is preferably moved axially relative to the transfer channel after the medical delivery device changes from the metered supply state to the delivery state, so that the opening of the transfer channel is sealed. Thus, in order to seal the transfer channel, the opening can be sealed by embedding it in the closure of the container. For example, when the container is closed by a rubber plug or a diaphragm, arranging the opening in the rubber plug or diaphragm allows it to be tightly closed by axially moving the container. In order to more effectively allow the tip to be sealed by axially moving the container, the opening of the tip can be in the side wall of the tip rather than at its sharp end.

Preferably, the transfer channel connects the container seat with the dosing chamber such that when a container containing a fluid is arranged in the container seat and the lever element is moved relative to the delivery orifice along the longitudinal axis of its stem by rotating the dial housing about the stem of the lever element in a first rotational direction, the fluid is transferred from the container to the dosing chamber. This allows for an efficient design of the delivery device.

Thus, the dial housing and transfer channel are preferably arranged such that, when the container is positioned in the container seat and the lever element is moved relative to the delivery orifice along the longitudinal axis of its stem by rotating the dial housing about the lever element in a second rotational direction opposite to the first rotational direction, fluid is transferred from the dosing chamber to the container. This allows for both incremental and decremental dosing options. Thus, the dose in the dosing chamber can be easily changed, adjusted, and repeatedly corrected until a precise amount of liquid is metered. After the medical delivery device is switched to the delivery mode, further metering or adjustment is no longer possible.

Preferably, the medical delivery device includes a counter coupled to the rod element such that the counter indicates the volume of the dose chamber formed by the rod element when the rod element is moved relative to the delivery orifice along the longitudinal axis of its stem by rotating the dial housing about the stem of the rod element. By coupling the counter to the rod element, movement of the rod element relative to the delivery orifice can be identified and directly reflected by adjusting a displayed number corresponding to the metered volume or selected dose. In this way, a precise and purely mechanical dose counter can be effectively implemented.

Thus, the counter is preferably decoupled from the rod element after the medical delivery device changes from the metering state to the delivery state. This allows the selected dose volume to remain indicated during and after delivery. This allows a purely mechanical marking to be provided to record the delivered volume of the liquid.

The first threaded arrangement of the rod element and the second threaded arrangement of the dial housing may include a thread and a male component. Thus, in the metered supply state, when the dial housing is rotated about the stem of the rod element, the male component can move along the threaded arrangement. The threaded arrangement can be implemented as an external thread on the stem of the rod element, and the second threaded arrangement can include a male component, such as a pin, extending into the external thread. Preferably, the first threaded arrangement of the rod element is a male threaded arrangement having at least one male component protruding from the stem, and the second threaded arrangement of the dial housing includes a thread for receiving the at least one male component. In order to protrude from the stem, the at least one male component can extend radially or approximately radially from the stem so that it protrudes radially away from the stem. The at least one male component can be a pin. It can be fixedly arranged on or at the stem.

BRIEF DESCRIPTION OF THE DRAWINGS

The medical delivery device according to the invention is described in more detail below with the aid of exemplary embodiments and with reference to the accompanying drawings, in which:

1 shows a front view of a starting position of an injection device as an embodiment of a medical delivery device according to the present invention in a metered delivery state;

FIG2 shows an exploded perspective view of the injection device of FIG1 ;

FIG3 shows a cross-sectional view of the injection device of FIG1 in a metered delivery state in a starting position;

FIG4 shows a front view of the injection device of FIG1 in a metered state after metered delivery;

FIG5 shows a cross-sectional view of the injection device of FIG4 ;

FIG6 shows a front view of the injection device of FIG1 after switching from the metering state to the delivery state;

FIG7 shows a cross-sectional view of the injection device of FIG6 ;

FIG8 shows a front view of the injection device of FIG1 in a delivery state after the needle shield has been removed;

FIG9 shows a cross-sectional view of the injection device of FIG8 ;

FIG10 shows a front view of the injection device of FIG1 in a delivery state after delivery;

FIG11 shows a cross-sectional view of the injection device of FIG10 ;

Figure 12 shows a front view of the injection device of Figure 1 in a delivery state after the needle has been covered and protected; and

FIG. 13 shows a cross-sectional view of the injection device of FIG. 12 .

DETAILED DESCRIPTION

In the following description, certain terms are used for convenience and are not intended to limit the present invention. The terms "right", "left", "up", "down", "below" and "above" refer to directions in the figures. The terms include the terms clearly mentioned and their derivatives and terms with similar meanings. In addition, spatial relative terms such as "under...", "below", "lower", "above", "upper", "proximal", "distal" may be used to describe the relationship between one element or feature structure and another element or feature structure as shown in the figures. These spatial relative terms are intended to cover different positions and orientations of the device in use or operation in addition to the positions and orientations shown in the figures. For example, if the device in the figure is turned over, the element described as being "under" or "below" other elements or features will then be "above" or "above" other elements or features. Therefore, the exemplary term "under..." can cover both above and below positions and orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations) and the spatial relative terms used in the text are explained accordingly. Similarly, descriptions of movement along and around various axes include various special device positions and orientations.

To avoid repetition in the drawings and the description of the various aspects and illustrative embodiments, it should be understood that many characteristic structures are common to many aspects and embodiments. Omitting an aspect from the description or drawings does not mean that the aspect is missing from the embodiment incorporating the aspect. On the contrary, the aspect may be omitted for clarity and a lengthy description may be avoided. In this context, the following applies to the rest of this specification. If, for the sake of clarity, a drawing contains a reference numeral that is not described in the directly relevant part of the specification, the reference numeral may be referred to in the preceding or following explanatory sections. In addition, for clarity, if a reference numeral is not provided for all features of a component in a drawing, it is referred to other drawings showing the same component. Similar reference numerals in two or more drawings represent identical or similar elements.

FIG1 shows an injection device 1, an embodiment of a medical delivery device according to the present invention, in a metered delivery state. The injection device comprises a housing 2 having a body 21 and a needle shield 22. The body 21 has an interior space, a top distal opening, and a bottom proximal opening. It is also equipped with an indicator window 211 located in the upper portion and a chamber window 212 located vertically below the indicator window.

In the interior space of the body 21, a rod element 3 is arranged, which has a vertically arranged stem 31 and a rubber stopper 32 at the lower end of the stem 31. The lower part of the stem 31 and the rubber stopper 32 can be seen through the cavity window 212 of the body 21 of the housing 2.

The metering actuator 5 extends through the distal opening of the housing 2 into the interior space of the body 21. The metering actuator 5 includes a grip ring 52 positioned outside the housing 2 and laterally overlapping the distal opening of the housing 2. As described in more detail below, the metering actuator 5 includes dose markings 53 as part of a counter for indicating the amount or volume of the metered medication. In the starting position shown in FIG1 , no medication is being metered, resulting in no volume being indicated in the visual element 213 of the indicator window 211. Specifically, an arrow indicating the direction of rotation for metering, i.e., counterclockwise, is visible through the visual element 213 of the indicator window 211. The dose markings 53 and the visual element are collectively included in the counter of the injection device 1.

The switching actuator 7 also extends through the distal opening of the housing 2 into the interior space of the body 21 and the metering actuator 5. The switching actuator 7 comprises a gripping ring 72 positioned outside the housing 2 and the metering actuator 5.

In FIG2 , the injection device 1 is shown in an exploded view so that the individual components are visible. The injection device 1 is designed to receive a vial 9 as a container. As is conventional, the vial 1 has a body 93 and a neck 91 closed by a cap 92. The interior of the body 93 contains a liquid drug to be transferred, metered, and delivered or injected using the plunger device 1.

The lever element 3 includes a cylindrical portion 33 that is dimensioned to cover approximately half the length of the lever element, i.e., its right half in FIG2 . The cylindrical portion 33 has a hollow interior dimensioned to receive the cylindrical portion 71 of the switching actuator 7. The switching actuator 7 is also substantially cylindrical and has a hollow interior shaped to receive a medicine bottle 9 and a medicine bottle holder 8 that serves as a container seat. The medicine bottle holder 8 has a neck retainer 81 and a cylindrical outer surface provided with a hub groove 82.

The rod element 3 is equipped with two opposing pins 35 as male/female parts of the outer or first threaded arrangement. The pins 35 project radially from the remainder of the rod element 3. The pins 35 are mounted somewhat flexibly so as to allow for inward pressing, i.e., in the direction toward the longitudinal axis of the rod element 3. The rod element 3 also includes two opposing stop fins 34 positioned near the proximal end of the rod element 3.

The medical injection device 1 also includes a dial housing 4 having two semi-cylindrical clamshells 41. On their inner surfaces, both clamshells 41 are provided with threaded sections, wherein the tread sections of the clamshells 41 are formed into two parallel, continuous threads 411 that form an inner or secondary thread arrangement when the clamshells 41 are pushed together to form a cylinder. At their proximal ends, the clamshells 41 are provided with an outwardly extending flange 413. Furthermore, each clamshell 41 is provided with a rim section 412 that protrudes radially or outwardly from its outer surface. The clamshells 41 are sized to fit around the cylindrical portion 33 of the rod element 3.

The metering actuator 5 has a cylindrical body 51 having a hollow interior space, with dose markings 53 provided at and around the outer surface of the cylindrical body 51. A grip ring 52 forms the distal end of the metering actuator 5. A pair of grooves 54 are provided in the cylindrical body 51, corresponding to the rim sections 412 of the clamshell 41. The metering actuator 5 is sized to be arranged around the clamshell 41 so that, when mounted around the cylindrical portion 33 of the lever element 3, the rim sections 412 engage with the grooves 54 and secure the dial housing 4 to the metering actuator 5.

Between the stem 31 of the rod element 3 and the proximal opening of the body 21 of the housing 2, a dosage unit 6 is arranged. The dosage unit 6 has a spring 63, a chamber cylinder 61 and a delivery needle 62 serving as a delivery orifice of the injection device 1. The chamber cylinder 61 is dimensioned such that the stem 31 of the rod element 3 and the rubber stopper 32 fit therein.

FIG3 shows the assembled injection device 1 in its starting position. The injection device 1 is presented in an upright position, with the proximal end at the bottom and the distal end at the top. As described above, the switching actuator 7 extends within the hollow interior of the cylindrical portion 33 of the lever element 3. Thus, the cylindrical portion 71 of the switching actuator 7 is located within the interior of the lever element 3, and the grip portion 72 of the switching actuator 7 protrudes upward from the lever element 3. More specifically, the grip portion 71 of the switching actuator 7 is sized so that it does not fit within the cylindrical portion 33 of the lever element 3, but rather abuts against its distal opening.

Inside the hollow interior space of the switching actuator 7, the medicine bottle holder 8 is positioned at the bottom 73 of the switching actuator 7. A hub protrusion 711 protrudes inwardly from the inner surface of the cylindrical portion 71 of the switching actuator 7 in a direction toward the medicine bottle holder 8. The hub protrusion 711 engages with the hub groove 82 of the medicine bottle holder 8 so that the switching actuator 7 and the medicine bottle holder 8 can interact as described in more detail below.

The lever element 3 has a central longitudinal axis 38 extending vertically in Figure 3. The longitudinal axis 38 of the lever element 3 coincides with the longitudinal axis of the housing 2, the dial housing 4, the metering actuator 5, the dosage member 6, the switching actuator 7, the vial holder 8, the vial 9 and the entire device 1.

The rod element 3 also has a transfer needle 37 that extends centrally through the stem 31 and the rubber stopper 32. The stem 31 extends upward into the interior of the cylindrical portion 33 and into the vial holder 8. The stem 31 is thus connected to the vial holder 8 in a torsionally rigid manner via interacting form-fitting portions. The transfer needle 37 extends axially from the bottom or proximal end of the rubber stopper 32, through the rubber stopper 32 and the stem 31, and protrudes above the top or distal end of the stem 31, terminating in a sharp tip 371. The stem 31 extends downward into the chamber cylinder 61 of the dose component 6.

The rubber stopper 32 is received by the stem 31 so that it is positioned at the bottom or proximal end of the stem 31. Thus, the rubber stopper 32 is completely located within the chamber cylinder 61 of the dose component 6. In the initial position shown in FIG3 , the rubber stopper 32 abuts the bottom 612 of the chamber cylinder 61. The proximal end of the rubber stopper 32 is concave, so that a minimum dose chamber 611 is formed within the chamber cylinder 61 between the rubber stopper 32 and the bottom 612 of the chamber cylinder 61. The bottom 612 of the chamber cylinder 61 has a downwardly extending support, through which a delivery needle 62 is provided. The bottom or proximal end of the delivery needle 62 is received in the sealing channel 221 of the needle shield 22 of the housing, thereby covering, protecting, and sealing the delivery needle 62.

The neck retainer 81 of the vial holder 8 has a retaining structure 811 comprising a vertical slit and an inwardly extending flange end. During the preparation step for the injection device 1, the vial 9 is pressed from top to bottom into the switching actuator 7 and the vial holder 8. The vertical slit thereby allows the retaining structure 811 to move sufficiently outward so that the head of the vial 9 with its cap 92 passes over the flange end of the retaining structure 811. Once the vial 9 is fully pressed downward, the flange end of the retaining structure 811 engages behind the head of the vial 9 and into the neck 91, retaining the vial 9. In this manner, the vial 9 is vertically mounted from top to bottom in the injection device 1, with its cap 92 abutting against the distal end of the stem 31 of the rod element 3. At the distal top opening of the switching actuator 7, a protrusion on the exterior of the body 93 of the vial 9, which engages and guides the vial, protrudes inward.

When the vial 9 is pressed into the vial holder 8, the tip 371 of the transfer needle 37 penetrates the cap 92 including the septum 921. The tip 371 forms the top or distal end of the transfer needle 37. When the vial 9 is fully retained in the vial holder 8, the transfer needle 37 extends into the interior space of the vial 9. A lateral opening 372 is provided in the transfer needle 37 at a position near but slightly below the tip 371. In the starting position shown in FIG3 , the transfer needle 37 forms an open conduit serving as a transfer channel between the interior space of the vial 9 and the dose chamber 611 of the dose component 6.

The pins 35 of the external thread arrangement of the lever element 3 protrude horizontally to the left and right from the rest of the lever element 3 into the internal threads 411 of the dial housing 4 formed by the two clamshells 41. Each pin 35 thereby engages with one of the two internal threads 411. The external thread arrangement of the lever element 3 also includes two protrusions 36 of the disengagement structure of the switching mechanism, which are located adjacent to the pins 35 and extend axially in an upward direction. Each protrusion 36 engages with a guide groove 731 of the disengagement structure of the switching mechanism implemented in the base 73 of the switching actuator 7. The guide grooves 73 extend in a plane perpendicular to the longitudinal axis 38 of the stem portion 31 of the lever element 3. They extend helically on the base 73 and continuously approach the center of the base 73.

The body 21 of the housing 2 further includes a bottom 213 having an opening, through which a support of the bottom 612 of the chamber cylinder 61 of the dose component 6 extends into the needle shield 22. Two retaining arms 214 and a spring seat 215 extend upward from the bottom 213 of the body 21 into the interior space of the body 23. Thus, the two retaining arms 214 engage behind corresponding skirt portions of the dose component 6. The coil spring 63 is sandwiched between the spring seat 215 and the horizontal surface of the dose component 6. Thus, the dose component 6 is connected to the body 21 of the housing 2 via the retaining arms 214, with the spring 63 pre-stressed between the body 21 and the dose component 6.

Figures 4 and 5 show the injection device 1 after metering, i.e., after 200 μl of medication has been transferred from the vial 9 into the dosing chamber 611. To perform metered delivery, as indicated by the arrow in Figure 4 , the metering actuator 5 is rotated counterclockwise relative to the housing 2. This allows the patient to hold the body 21 of the housing 2 with one hand and to rotate the grip ring 52 of the metering actuator 5 relative to the housing 2 with the other hand. Because the clamshell 41 of the dial housing 4 is connected to the metering actuator 5 in a torsionally fixed manner via the rim section 412 protruding into the recess 54, the dial housing 4 rotates along with the metering actuator 5. Simultaneously, the lever element 3 is connected to the housing 2 in a torsionally fixed manner via the dosing component 6 and the retaining arm 214 of the housing 2, preventing it from rotating about its axis 38. Consequently, the dial housing 4 rotates about the lever element 3, causing the pin 35 to travel along the thread 411. This causes the lever element 3 to move upward along the longitudinal axis 38 of the stem 31.

When the rod element 3 is moved axially upward, the metering chamber 611 between the rubber stopper 32 and the bottom of the chamber cylinder 61 of the dosing component 6 expands. Simultaneously, a low pressure or partial vacuum is created in the metering chamber 61, causing the drug to be drawn from the vial 9 through the transfer needle 37 into the metering chamber 611. The threads 411 of the dial housing 4 are provided with small irregularities. These irregularities are distributed along the threads 411 so that the movement of the pin 35 between two adjacent gaps causes the volume of the dose chamber 611 to change by a predetermined amount, for example, 25 μl. When the pin passes through one of the gaps in the threads 511, an audible and tangible click is generated. Therefore, when the patient turns the metering actuator 5 and notices the click, they know that the metered volume of the drug has changed, for example, by 25 μl.

As the metering actuator 5 rotates relative to the housing 2 during metering, the amount visible in the visual element 213 of the indicator window 211 changes accordingly with the volume of medication in the metering chamber 611. More specifically, the visual element 213 is guided within the indicator window 211, allowing it to move axially and vertically relative to the main body 21 of the housing 2, but not tangentially. Furthermore, the outer surface of the main body 51 of the metering actuator 5 is provided with threaded ribs that connect to the visual element 213 via corresponding grooves. Therefore, as the metering actuator 5 rotates relative to the housing 2, the visual element 213 moves vertically through the interaction between the threaded ribs and the grooves. Compared to Figure 1 , where the visual element 213 is located at the bottom of the indicator window 211, in Figure 4 , it has moved upward and is positioned above the number 200 in the dose marking. This indicates that 200 μl of medication has been transferred into the dose chamber 611.

When in the metering state or mode, the metering actuator 5 can be rotated in two directions. Thus, anti-clockwise rotation causes the dose volume 611 to increase, and conversely, clockwise rotation causes the dose volume 611 to decrease, so that the drug is transferred back to the vial 9.

Figures 6 and 7 show the injection device 1 after switching from the metering state or mode to the delivery state. As indicated by the arrow in Figure 6 , to perform the switching operation, the switching actuator 7 is rotated clockwise relative to the housing 2 and, as described above, the lever element 3 connected to the housing 2. Thus, the patient can also hold the body 21 of the housing 2 with one hand and rotate the grip ring 72 of the switching actuator 7 relative to the housing 2 with the other hand.

Because the guide groove 731 located at the bottom 73 of the switching actuator 7 extends helically and continuously approaches the center of the bottom 73, when the switching actuator 7 is rotated and the projection 36 simultaneously travels along the guide groove 731, the projection 36 of the external thread arrangement moves toward the axis 38. The entire arm including the pin 35, together with the projection 36, moves toward the longitudinal axis 38, causing the pin 35 to disengage from the thread 411 of the dial housing 4. In the delivery state shown in FIG7 , the pin 35 is completely disengaged from the thread 411. As a result, rotation of the metering actuator 5 no longer moves the lever element 3, and the pin 35 no longer prevents axial movement of the lever element 3.

Furthermore, since the container seat 8 is connected to the rod element 3 in a torsion-resistant manner, the switching actuator 7 also rotates around the medicine bottle seat 8. In particular, the cylindrical portion 71 together with its hub protrusion 711 rotates around the medicine bottle seat 8. As a result, the hub protrusion 711 travels along the hub groove 82 of the medicine bottle seat 8, wherein, due to the design of the hub groove 82, the medicine bottle seat 82 together with the medicine bottle 9 is lifted. In the position shown in Figures 6 and 7, the medicine bottle 9 is axially lifted to such an extent that the diaphragm 921 of the cover cap 92 of the medicine bottle 9 covers the side opening 372 of the transfer needle 37 of the rod element 3. In this way, the transfer needle 37 is sealed and the conduit between the medicine bottle 9 and the dosage chamber 611 is securely closed. Therefore, it is not possible to transfer medicine between the medicine bottle 9 and the dosage chamber 611.

Figures 8 and 9 show the injection device 1 in its delivery state, ready for injection of a drug. As shown by the arrow in Figure 8, the needle shield 22 is pulled downwardly away from the body 21 of the housing 2. Thereby, the delivery needle 62 is exposed and ready for delivery.

In Figures 10 and 11 , the injection device 1 is shown in its delivery state after an injection. As indicated by the arrow in Figure 10 , the switching actuator has moved downward. More specifically, to deliver the medication, an axial force is applied to the vial 9 extending upward from the switching actuator 7. For example, this axial force can be applied by the patient's thumb, with the housing 2 being held by the patient. During delivery, the axial force is transmitted from the vial 9 via the vial holder 8 to the lever element 3, causing its rubber stopper 32 to be pressed into the dosing chamber 611, and the medication is dispensed from the needle 62. After delivery, as shown in Figure 11 , the volume of the dosing chamber 611 is minimized, allowing the medication to be substantially completely delivered.

In addition, while the rod element 3 is axially moved in the downward direction, the retaining arms 214 are urged inwardly in the direction toward the axis 38. After the injection, the retaining arms 214 are completely disengaged from the corresponding skirt portion of the dose component 6, causing the housing 2 and the dose component to separate from each other. As shown in Figures 12 and 13, this allows the elastic force of the spring 63 to be initially pre-stressed between the spring seat 215 of the body 21 of the housing 2 and the horizontal surface of the dose component 6 to axially move the body 21 relative to the other parts of the injection device 1 and, in particular, also relative to the needle 62. In this way, the needle 62 is completely covered by the body 21, which can prevent needle punctures after drug delivery.

This specification and the drawings illustrating aspects and embodiments of the invention should not be construed as limiting the claims defining the protected invention. In other words, although the invention has been shown and described in detail in the drawings and the preceding description, such illustration and description should be considered illustrative or exemplary rather than restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of the description and claims. In some cases, well-known circuits, structures, and techniques are not shown in detail so as not to obscure the present invention. Therefore, it should be understood that changes and modifications may be made by one of ordinary skill in the art within the scope and spirit of the following claims. In particular, the present invention encompasses other embodiments having any combination of the features of the different embodiments described above and below.

The present disclosure also encompasses all other features shown in the drawings, even though they may not have been individually described in the preceding or following description. Furthermore, a single alternative of the embodiments and features thereof depicted in the drawings and description may be disclaimed from the subject matter of the present invention or from the disclosed subject matter. The present disclosure encompasses subject matter consisting of the features defined in the claims or exemplary embodiments as well as subject matter containing said features.

Furthermore, in the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may perform the functions of multiple features recited in the claims. The mere fact that specific measures are recited in mutually different dependent claims does not mean that a combination of these measures cannot be used advantageously. The terms "substantially/roughly", "about", "approximately", etc., in conjunction with an qualifier or value, in particular also clearly define the qualifier or clearly define the value, respectively. The term "about" in the context of a given numerical value or range refers to a value or range, for example, within 20%, within 10%, within 5% or within 2% of the given value or range. Components described as coupled or connected may be directly coupled electrically or mechanically, or they may be indirectly coupled via one or more intermediate components. Any figure marks in the claims should not be interpreted as limiting the scope of protection.

Claims (15)

1. A medical delivery device, comprising: A rod element (3) having a stem (31) having a longitudinal axis (38), a first threaded device (35, 36), a proximal end, and a distal end. Dial housing (4), which has a second threaded device; and A delivery orifice (62) is arranged near the proximal end of the stem (31) of the rod element (3). In the metering supply state of the medical delivery equipment... The first threaded device (35, 36) of the lever element (3) engages with the second threaded device of the dial housing (4), and The first threaded device (35, 36) of the rod element (3) and the second threaded device of the dial housing (4) can be moved relative to the delivery port (62) along the longitudinal axis (38) of its stem (31) by rotating the dial housing (4) about the stem (31) of the rod element (3), wherein a dose chamber (611) is formed between the rod element (3) and the delivery port (62), and the dose chamber (611) increases as the rod element (3) moves away from the delivery port (62). Its characteristic is that it further includes: A switching mechanism (7, 36) for changing the medical delivery device from a metering supply state to a delivery state, the switching mechanism including a disengagement structure, wherein... Under the metering supply condition of the medical delivery equipment. Movement of the rod element (3) along the longitudinal axis (38) of its stem (31), achieved by applying an axial force to the rod element (3) through the engagement between the first threaded device of the rod element and the second threaded device of the dial housing, is prevented. In the transport state of the medical transport device The rod element (3) can be moved relative to the conveying orifice (62) along the longitudinal axis (38) of its stem (31) by applying an axial force to the rod element (3), and The movement of the rod element (3) along its longitudinal axis (38) is prevented by means of the disengagement mechanism of the switching mechanism that disengages the first threaded device of the rod element from the second threaded device of the dial housing after the medical delivery device changes from the metering supply state to the delivery state. This is achieved by rotating the dial housing (4) around the stem (31) of the rod element (3). 2. The medical delivery device according to claim 1, wherein the disengagement structure (731, 36) of the switching mechanism (7, 36) includes a protrusion (36) disposed at the first threaded device (35, 36) of the rod element (3) and a guide groove (731) into which the protrusion (36) extends, wherein, after the medical delivery device changes from the metering supply state to the delivery state, the guide groove (731) moves and the protrusion (36) travels along the guide groove (731), such that the first threaded device (35, 36) of the rod element (3) disengages from the second threaded device of the dial housing (4). 3. The medical delivery device according to claim 2, wherein the protrusion (36) of the disengagement structure (731, 36) extends axially and the guide groove (731) extends in a plane substantially perpendicular to the longitudinal axis (38) of the stem (31) of the rod element (3), wherein the guide groove (731) is shaped such that when the guide groove (731) rotates about the longitudinal axis (38) of the stem (31) of the rod element (3), the protrusion (36) moves toward the longitudinal axis (38) of the stem (31) of the rod element (3). 4. The medical delivery device according to any one of the preceding claims, wherein the threads (411) of the first threaded device (35, 36) of the rod element (3) and/or the second threaded device of the dial housing (4) are provided with a plurality of irregular portions, the plurality of irregular portions being positioned at a fixed distance from each other, such that when the dial housing (4) is rotated about the longitudinal axis (38) of the rod element (3), the first threaded device (35, 36) of the rod element (3) and the second threaded device of the dial housing (4) interact with one of the plurality of irregular portions at a predetermined rotation angle. 5. The medical delivery device according to claim 4, wherein the irregular portion is positioned such that rotating the dial housing (4) by about the predetermined rotation angle causes the dosage chamber (611) to change by a predetermined volume. 6. The medical delivery device according to any one of claims 1 to 3, wherein the rod element (3) includes a transfer channel extending through the stem (31) along a longitudinal axis (38) of the stem (31). 7. The medical delivery device according to any one of claims 1 to 3, comprising a container seat (8) connected to the distal end of the stem (31) of the rod element (3). 8. The medical delivery device according to claim 6, comprising a container seat (8) connected to the distal end of the stem (31) of the rod element (3), wherein the transfer channel includes a tip (371) and an opening (372), wherein, in the metering supply state of the delivery device, the tip (371) and the opening (372) protrude into the container seat (8) such that the tip and the opening extend into the container (9) when the container (9) is arranged in the container seat (8). 9. The medical delivery device according to claim 6, wherein the transfer channel of the rod element (3) is closed after the medical delivery device changes from the metering supply state to the delivery state. 10. The medical delivery device according to claim 8, wherein the transfer channel of the rod element (3) is closed after the medical delivery device changes from the metering supply state to the delivery state, and the container seat (8) moves axially relative to the transfer channel after the medical delivery device changes from the metering supply state to the delivery state, such that the opening (372) of the transfer channel is sealed. 11. The medical delivery device according to claim 7, wherein the rod element (3) includes a transfer channel extending through the stem (31) along a longitudinal axis (38) of the stem (31), wherein the transfer channel connects the container seat (8) to the dose chamber (611) such that when a container (9) containing fluid is arranged in the container seat (8) and the rod element (3) is moved relative to the delivery orifice (62) along the longitudinal axis (38) of its stem by rotating the dial housing (4) about the stem (31) of the rod element (3) in a first rotational direction, fluid is transferred from the container (9) to the dose chamber (611). 12. The medical delivery device according to claim 11, wherein the dial housing (4) and the transfer channel are arranged such that when the container (9) is arranged in the container seat (8) and when the rod element (3) is moved relative to the delivery orifice (62) along the longitudinal axis (38) of its stem (31) by rotating the dial housing (4) about the stem (31) of the rod element (3) in a second rotation direction opposite to the first rotation direction, fluid is transferred from the dose chamber (611) to the container (9). 13. The medical delivery device according to any one of claims 1 to 3, comprising a counter (213, 53) coupled to the lever element (3) such that the counter (213, 53) indicates the volume of a dose chamber (611) formed by the lever element (3) when the lever element (3) is moved relative to the delivery orifice (62) along the longitudinal axis (38) of its stem (31) by rotating the dial housing (4) about the stem (31) of the lever element (3). 14. The medical delivery device according to claim 13, wherein the counter (213, 53) disengages from the rod element (3) after the medical delivery device changes from the metering supply state to the delivery state. 15. The medical delivery device according to any one of claims 1 to 3, wherein the first threaded device (35, 36) of the rod element (3) is a male threaded device (35, 36) having at least one male part (35) protruding from the stem (31), and the second threaded device of the dial housing (4) includes a thread (411) for receiving the at least one male part (35).