JP4344344B2 - Dosing device - Google Patents

Description

  The present invention relates to a device for administering or dispensing a selected amount of a substance, including a device used in medicine. In particular, the present invention relates to a device for delivering a selected amount or dose of a substance, including a dosing device that provides a semi-automatic priming function, and a dose administration of an injectable product.

  Devices for dose administration or delivery of drugs such as insulin, hormones and the like are well known. Such devices have an injection device, including what is known as an injection pen. An injection pen is an injection device that can be activated by a patient, such as a diabetic patient, to self-administer a desired dosage of insulin. Typically, such injection pens have a dosing knob that protrudes from an opening in the housing. For administration by injection, the dosage to be administered is selected or set by the dosing knob. The drive means is preset by turning the dosing knob. For injection, the dosing knob is then moved slightly forward from the first end position into the housing until the second end position is reached. In this step, a pre-set amount of product to be injected is administered. Furthermore, in the injection process, the drive means moves forward and acts on the piston, which acts on the injectable product in the ampoule, so that the drug is displaced from the ampoule and passes through the cannula. Extruded or fed.

  After drug administration, it is typically necessary to prepare the injection pen for a new subsequent injection by performing a priming process. As is known, in this step, the injection cannula is not carried out, but by extruding a small amount of product to be injected, the cross section or central bore of the injection cannula is evacuated and residual material is removed.

  This priming step, which can be simply referred to as priming, is an additional work step for patients who must make injections, and this step should not be forgotten if an optional injection after priming should be made Is. In at least one known dispensing device or injection pen, priming is performed by effecting a switch from the administration position to the priming position by rotating the adjustment section. This adjustment must be reset again for the next dose or injection. This requires additional effort and attention from the patient. This is exactly a mentally tiring situation where the patient may be neglected or improperly performed this operating step if a quick insulin injection has to be made completely.

  Accordingly, it is an object of the present invention to provide an injection and / or dosing device that allows another way of achieving the priming function. Furthermore, it is an object of the present invention to make available a simplified priming function that can be advantageously incorporated into existing mechanical elements of the dispensing device.

  In one embodiment, the present invention is a device for dosage administration of an injectable product, the device comprising a housing with a container for the product and a displaceable support within the housing. And a drive mechanism that can be moved through the dosing element, the drive mechanism having a plurality of groups of engaging elements that are arranged together to form a group, the distance between the groups corresponding to the dose of the injectable product The distance between the engaging elements corresponds to the priming amount of the injectable product, and the dosing element interacts with one group of engaging elements at one time to administer the dosage. , Coupled to the drive mechanism to interact with one engagement element at another time to release the priming amount. The present invention can include a method of using an injection or dosing device having the step of priming the device.

  In one embodiment, the present invention is a device for injectable product dosage administration having a housing with a container for the product, and a delivery means for a predetermined dosage And provided with drive means for transporting means, the drive means being able to move via a dosing element that is displaceably supported in the housing, according to the invention the drive means are arranged in a collective manner. Multiple engaging elements forming a group, the dosing distance between the groups corresponds to the dosage, the priming distance between the engaging elements corresponds to the priming amount of the injectable product, To administer an amount of injectable product and release the priming amount at another time point, the dosing element interacts with one group of engagement elements at one time point and one engagement at another time point Interaction with elements In so that manner, dosing device is coupled to the driving means.

  In one embodiment, the present invention is a dispensing device in which a section or portion of the device for dispensing is coupled to a priming device. In particular, means are provided for providing a plurality of groups of engaging elements that are arranged together to form a group, the dosing distance between the groups corresponding to the dosage, and the priming distance between the engaging elements corresponding to the priming amount.

  Further, in accordance with a preferred embodiment, depending on the circumstances, the dosing knob or dosing element is associated with one group of engaging elements to administer the dosage at one time point and the priming amount at another time point. The dosing knob can be connected to the drive means in such a way as to interact and interact with the individual engagement elements at different times. In this design according to the invention, the drive means for dose administration also has the ability to control the priming function in an integrated and immediate manner. In this way it can be ensured that the priming function precedes each administration function and follows the latter respectively. Furthermore, the first priming function after a new ampoule has been installed can be managed in this way.

  Of course, different suitable dosing elements can be used in place of the dosing knob as long as the patient can transmit the force that ultimately results in dosing or delivery of the dose. Thus, the term “dosing knob” should be considered as an illustration of any suitable dosing or dosage setting element or structure.

  Advantageously, an advance sleeve connected to the dosing knob is provided. The advance sleeve acts on the drive means to transmit a propulsive force from the dosing knob to the drive means. Thus, the advancement sleeve provides a transmission element, whereby the propulsive force applied by the patient can be transmitted to the drive means via the dosing knob and the advancement sleeve to act on the piston, which piston is applied to the dosing device. The injectable product is extruded from an ampoule or other reservoir or container located within.

  Advantageously, the group of engagement elements has at least two engagement elements. The distance between two successive groups of engaging elements is used to allow maximum movement, i.e. to dispense a predetermined dose.

  The distance between two consecutive engagement elements of the group can be determined or selected so that this distance accurately corresponds to the amount of priming that should be driven to perform the priming function.

  When a person operating a dosing device according to the present invention wishes to perform an injection or administration, the person pulls on the dosing knob, whereby the knob advances in a direction opposite to the push-out direction, i.e. away from the needle. Is moved in the axial direction. The advancing sleeve moves a dosing distance so that the engagement catch on the advancing sleeve section which is at least in the cross-section of the forceps can engage with the engagement element of the next group of engagement elements of the drive means . Subsequently, the patient can move the dosing knob in the push-out direction of the injection needle, whereby the dosing knob moves the advance sleeve axially forward, thereby driving eg screw rods, toothed rods etc. Advance the means. The drive means acts on the piston and causes the extrusion of a quantity of injectable product, such as insulin. Subsequently, in order to prepare for the next injection, the patient can pull the dosing knob again so that the catch on the advance sleeve is disengaged from the engagement element of that group and the next engagement of the same group. Move to the combined element. When the patient has fully pulled back the dosing knob over a distance corresponding to the dosing distance, the catch on the advance sleeve slides across the drive means over the distance without the engagement element, but on the advance sleeve The catch cannot engage the next group of engagement elements. This is because the advancement sleeve cannot move the additional distance required for engagement due to the limited distance that the dosing knob can move. Subsequent actuation of the dosing knob causes the advancement sleeve to advance again without being able to engage the engagement element. Only when the catch of the advance sleeve has engaged the last engagement element of the previous group, the drive means can advance again, corresponding to the short distance between the engagement elements of the group, the priming Only quantities of injectable product are extruded.

  After this step is complete, the patient can then re-pull the dosing knob back so that the catch on the advance sleeve is also disengaged from the last engagement element, and the next group of engagement elements As long as there is not present, it will slide over the drive means and will engage the next group of engagement elements when the dosing knob has been pulled out of the maximum possible distance. This maximum distance corresponds in principle to the maximum propulsion movement that can release the maximum possible dosage. Thus, one group of engagement elements has at least two engagement elements, in which case the distance between the two engagement elements of one group should correspond to the priming amount and between the two groups The distance should correspond to the maximum dosage. Doses other than the maximum dosage can be set separately, for example by a settable propulsion path for the drive means and / or the advance sleeve. That is, the dosing knob can always pull back the same distance in relation to the advance sleeve, but the drive means or advance sleeve can be adjusted to allow different amounts of injectable product to be dispensed, depending on the circumstances. You can move forward as much as possible.

  In certain embodiments, advantageously, the group of engagement elements is characterized by the fact that the distance between the groups of engagement elements is greater than the distance between the engagement elements of the group. This is generally true. The reason is that the priming amount is generally smaller than the dosage or injection amount.

  To further facilitate operation by the patient, the dispensing device according to the present invention can be provided with a priming indicator. This indicator provides a signal indicating that actuation of the drive means and / or the dosing knob has provided for the priming function. In this way, the patient does not need to remember the current operating state of the device, which improves functional reliability.

  In one embodiment, the injection or dosing device according to the invention is similarly engaged with the engaging element of the drive means to allow the advancement device to hold the drive means in place while being pulled by the dosing knob. It is possible to have a guide device, for example a guide sleeve. Variable dosing can be effected via the engaging position of the guide device and the engaging position of the advance sleeve, ie the distance between them. Here, the dosing knob can always be pulled back over the same distance, but the stopper on the advance sleeve must be set appropriately so that the drive movement is adjustably limited to adapt the spacing of the engagement positions. Don't be.

  According to one embodiment of the invention, the drive means have an equal distance between at least some groups of engagement elements. With these equal distances between groups, it is possible to set a fixed individual dose of injectable product. The dispensing device according to the present invention is also used as an extendable pen. That is, in this case, no additional ampoule is required, but the product can be accommodated without directly placing a replaceable ampoule in the housing container.

  In a preferred embodiment, the drive means are formed between the groups in a smooth manner, i.e. between groups, the drive means do not have engaging elements or structures belonging to the group.

  FIG. 1 shows an embodiment of the device according to the invention, which device comprises an end (which can be called the front end) carrying a needle or cannula N surrounded by a protective cap S. A housing 1 is provided. A separate jacket for the needle N can be provided, but this jacket is generally removed on first use and is only placed with a new needle N attachment or attachment for sterility reasons. .

  An ampoule 3 further provided in the housing 1 comprises a piston 4 which can be moved inside the ampoule in order to be able to push out the injectable product. In the axial direction of the cylindrical housing 1, a driving means 5 such as a toothed rod or a screw rod is attached to the piston 4. The drive means moves axially, forward in the direction of the injection needle N and backward in the direction of the dosing knob 9 in the guide device, in particular in the guide sleeve 25 and in the advance device, in particular in the advance sleeve 7.

The dosing knob 9 is fixed to the advancement device or advance sleeve 7 depending on the circumstances. The medication knob 9 has an indicator 30 intended to indicate that the priming function can be performed.
The elements of the dispensing device according to the present invention will be further described below with reference to FIGS. It should be noted that in the figures the same reference numerals are used for identical or functionally similar elements, so that repeated explanation of the same elements is not necessary.

In FIG. 2, the drive means comprising the toothed rod 5, the advance sleeve 7 and the guide sleeve 25 are represented in cross-section in a general manner.
The toothed rod 5 has several groups 5a of engagement elements 5b, 5c, 5d, which according to their function have a certain distance between the groups as shown in FIG. The front group 5a has three teeth arranged to allow a first bleed or priming after the placement of a new ampoule. Correspondingly, every subsequent group 5a of teeth comprises three teeth. The group 5a following the front group 5a has two teeth and the group following the group 5a with three teeth also has two teeth, which are given doses ( It is sufficient for the front teeth 5d) and the priming function. All subsequent groups (not visible here) can have two teeth as well to perform the dosage administration and priming functions. Although a tooth or tooth-like structure is shown as an engagement element, it should be appreciated that any suitable structure integral with or attached to the toothed rod can be used.

  The advance sleeve 7 has two tooth-like jaws 7c with respective engagement catches 7b which can be engaged with the engagement elements or teeth of the group of engagement elements 5a depending on the circumstances. The teeth 5b to 5d are shaped so that the jaw 7c can be expanded by the advancement of the toothed rod 5, in the advancement direction of the toothed rod 5 with respect to the cylindrical axis of the cylindrical housing 1 (FIG. 1) of the device. The teeth have flanks with a fairly acute angle with respect to the cylindrical axis of the housing 1 (FIG. 1), which can be, for example, in the range of approximately 30 to 60 °. This design allows the teeth 5b-5d to be disengaged from the catch 7b of the advance sleeve.

  On the contrary, in the advance direction of each tooth of the toothed rod 5, the rear flank is opposite to the advance direction of the toothed rod 5, and the front end of the tooth-like jaw 7c oriented perpendicular to the cylindrical axis of the housing. It is formed as very steep so as to counteract a large resistance in the direction opposite to the advance direction, so that the displacement of the toothed rod 5 in the direction opposite to the advance direction is impossible or substantially It becomes impossible.

  The guide device or guide sleeve 25, like the advance sleeve 7, is designed to have two tooth-like jaws 25c. The tooth-like jaw 25c is provided with a catch 25b that can be engaged with the teeth 5b-5d to hold the toothed rod 5 in one position while the device according to the invention is put into a different working state. Pulling on the advance sleeve 7 by the knob 9 releases the engagement between the advance sleeve 7 and the current tooth.

  The guide sleeve 25 has a stopper 25a, in order to limit the forward movement of the advance sleeve relative to the guide sleeve 25 in the advance direction, the corresponding stopper 7a (FIG. 3) of the advance sleeve abuts against this stopper 25a, thereby The forward movement of the toothed rod 5 is also limited.

  In certain embodiments, the present invention provides a sequence of sequential administration and priming procedures. A new ampoule 3 can be inserted into the housing 1. The catch 7b of the tooth-like jaw 7c then engages with the engagement element of the group 5a having three teeth already carried to the advanced position in order to carry out the first bleed of the needle N, and the dosing knob Immediately after is pushed in the direction of the cannula N (FIG. 1), the toothed rod 5 is moved forward in the axial direction. The third tooth from the front of the front group with three teeth is disengaged from the catch 25b of the front tooth-like jaw 25c of the guide sleeve 25, and the last tooth of the frontmost group of teeth. Hooked behind the rear flank. Accordingly, the front end of the toothed rod 5 presses the piston 4 to cause the first priming and prepares the device. Subsequently, the dosing knob 9 is pulled. The dosing knob 9 is firmly connected to the advance sleeve 7, and the catch 7b at the front end of the advance sleeve 7 is disengaged from the previously engaged tooth by pulling the dosing knob 9 rearward.

  When the dosing procedure is performed, the tooth-like jaw 7c slips and slides along the toothless shaft segment of the toothed rod 5 between the groups of teeth to engage the next tooth of the next group. Or run. In this situation, the dosing knob is then fully withdrawn, and pressing of the dosing knob 9 in the direction of the injection needle N causes the piston 4 to produce a dose of injectable product in the ampoule 3. To move forward.

  With the next actuation, when the dosing knob 9 is pulled back again, the advance sleeve 7 also moves back and slips on the inclined flank of the next tooth of the toothed rod 5, i.e. the tooth 5c of the corresponding group 5a of the tooth. As the dosing knob is pulled further, the advance sleeve slips over the toothless area of the toothed rod 5 but cannot reach the next tooth of the next group within its gripping range. Then, when the dosing knob is pressed, the tooth-like jaw 7c slips back on the toothless area of the toothed rod 5 and is then hooked behind the steep flank of the tooth, making a small distance advancement. The priming function can be performed continuously.

The tooth-like jaws 25c, 7c can deflect radially and move radially when the dispensing knob and the advancement sleeve are pulled therethrough, in which case the catches 7b, 25b are connected to the toothed rod 5 Slip on the relevant teeth. Subsequently, each tooth-like jaw returns to its initial radial position.
Subsequently, the above operation is repeated, and of course, the first priming occurs after the insertion of a new ampoule.

  In FIG. 4, the dosing distance D between successive groups of teeth is clearly shown. Similarly, the priming distance P between successive teeth in the group of teeth is also shown. It should be appreciated that the dosing distance is substantially shorter than the priming distance.

  5a-5c show the priming indicator 30 in detail. In the dosing device according to the present invention, in the dosage setting state of FIG. 5a, the priming indicator lobe 30a abuts against the wall of the housing 1 and is therefore not visible from the outside. The leaf spring 39c presses the indicator lobe 30a in the direction of the wall of the housing 1. The leaf spring 30c is attached to the dispensing knob 9 or the lower section of the advance sleeve 7. Here, when the dosing knob 9 is pulled, the indicator lobe 30a can slip into the indicator slot in the wall of the housing 1 and then be perceivable from the outside. This position is intended to indicate that the device is ready for the priming procedure and that priming should be performed.

In FIG. 5c, a “0” position is shown, in which the indicator lobe 30a indicates the neutral position of the device.
Thus, according to the present invention, a dosing or injection device is made available, which makes the priming process easier for the user or patient. The user performs the appropriate function continuously and does not start the injection if the priming is to be performed, and conversely, if the injection is to be performed, the user simply does not start the priming.

  In the above description, embodiments of the present invention including preferred embodiments have been shown for the purpose of illustration and description. However, these embodiments are not exhaustive and these embodiments do not limit the invention to the precise shapes and processes disclosed. Modifications and variations are possible in light of the teaching herein, and all such modifications and variations are included within the scope of the invention as specified in the claims.

It is a longitudinal cross-sectional view of the axial direction which passes along the apparatus based on this invention. 2 is an axial longitudinal section through the drive zone modified according to the invention of the device of FIG. 1 in a dispensing position; FIG. It is a figure corresponding to FIG. 2 which shows the state in which the priming function is performed. FIG. 4 is a diagram corresponding to FIGS. 2 and 3, showing a state where the medication has been executed and the priming function is continuing. 5 and 5a to 5c are cross-sectional views through the apparatus of FIG. 1 in the area of the priming indicator at different locations.

Explanation of symbols

1 Housing 3 Ampoule 4 Piston 5 Drive means (toothed rod)
5a group 5b-5d engagement element 7 advance sleeve 9 dosing knob 25 guide sleeve 30 indicator D dosing distance P priming distance

Claims (12)

a) a housing (1) having a container (3) for the product;
b) a transport means (4) for transporting a dosage of product to be administered;
c) driving means (5, 7) for the conveying means;
d) a dosing element (9) coupled to the drive means ;
Have
In the dispensing device for dispensing an injectable product, the drive means having an engagement element and being displaceable within the housing,
The plurality of engagement elements (5b, 5c, 5d) constitute one engagement element group (5a),
A plurality of engagement element groups are spaced from each other, and the distance between the engagement element groups is a dosage distance (D) corresponding to the dose of injectable product, and the engagement within one engagement element group A dosing device, characterized in that the distance between the elements is a priming distance (P) corresponding to the amount of product injection. The above dosing device has a combined dose knob to the drive means via a displacement device (9), whereby the dosing element is a single point in time, in order to administer the dosage, one of said engagement It interacts with engagement element groups, at another time, dispensing device as claimed in claim 1, characterized in that interacting with one engagement element in one engagement element groups in order to release the priming amount . Coupled to said dosing device to transmit a driving force to said driving means from said dose knob, dispensing device as claimed in claim 1, further comprising a displacement element which engages in the drive element. 3. A dosing device according to claim 2, wherein one of the engagement element groups has at least two engagement elements. The engagement element group is determined by the fact that a greater distance is provided between the engagement element groups than the distance between the engagement elements in one engagement element group . 2. The dosing device according to 1 . 2. The dispensing device according to claim 1 , further comprising a priming indicator (30) signaling that actuation of at least one of the drive means and the dispensing knob has resulted in priming function preparation. 7. The dispensing device according to claim 6 , wherein the priming indicator is activated by a displacement element. 7. The dispensing device according to claim 6 , wherein the priming indicator is actuated by a displacement element having an advance sleeve, and the advance sleeve is mechanically coupled to the priming indicator. 2. The medication device according to claim 1 , further comprising a guide device (25) for holding the drive means in a position displaced by a forward movement. In order to be able to administer a same dosage, a number of dispensing device as claimed in claim 1, the same distance between said engagement element groups characterized in that it is provided. The dosing device according to claim 1 , wherein the driving means has a smooth area between the engaging element groups. It has said driving means a smooth region between the engagement element groups, the smooth region, dispensing device as claimed in claim 1, characterized in that has no engagement elements belonging to the engagement element group.

Images