Portable electronic injection device for injecting liquid medication

The present invention relates to a hand-held electronically controlled injection device that injects a liquid drug, and more particularly to a type of injection device that performs subcutaneous injection completely automatically.

As is known, certain types of diseases, such as diabetes, require injection of a drug, such as insulin, several times a day, and the dose of drug to be injected may vary from patient to patient. Yes, even the same patient may vary from day to day, and may vary from day to day.

Therefore, over the past few years, electronically controlled injection instruments have been devised and widely used to allow self-injection of the required dose of drug.

U.S. Patent Application Publication No. 2002/01133113 describes such a single injection instrument with a substantially handheld housing, which contains a cartridge containing a liquid drug for injection. The contact surface in contact with the patient's skin is provided with a through opening for attaching a disposable needle to one end of the cartridge. The injection instrument further comprises an electromechanical actuator assembly in which the plunger is airtightly slid inside the cartridge body and selectively actuated to administer a liquid drug through a needle into the patient's skin. ..

The operation of the injection instrument is controlled by a programmable microprocessor, which receives signals from various switches and buttons, such as one or more drug dose selection and injection start buttons. , And stored in the microprocessor. Signals to control the actuator assembly according to the program.

Therefore, the above-mentioned injection device can select each drug dose for injection and automatically administer this dose.

<p><patcit num="1"><text>U.S. Patent Application Publication No. 2002/0133113</text></patcit></p>

<p> Although the above types of injection instruments are functionally effective, there is still room for further improvement. Specifically, there is a need for solutions designed to further reduce the amount of human intervention required, to adjust the drug, and to further protect inexperienced users in automatic injections. ..</p><p> An object of the present invention is to provide an electronically controlled injection device that injects a liquid agent that is designed to meet the above requirements and is capable of completely automatically preparing and performing a subcutaneous injection. ..</p>

<p> According to the present invention, it is a handheld electronically controlled injection device that injects a preset dose of a liquid drug, has a contact surface in contact with the patient's skin, and accepts a drug container containing the liquid drug. In an injecting instrument having such a housing, an injecting instrument having a first actuator means for moving a drug container to and from a contact surface in the housing is provided.</p>

<figref num="1">It is a front view of the injection machine of 1st Embodiment of this invention.</figref><figref num="2">It is an enlarged perspective view of the internal component of the injection machine of FIG. 1 as viewed from one side, and is a view in which some parts are omitted for the sake of clarity.</figref><figref num="3">It is an enlarged perspective view of the internal component of the injection machine of FIG. 1 as viewed from the opposite side, and is a view in which some parts are omitted for the sake of clarity.</figref><figref num="4">It is a figure which shows a part of the injection machine of FIG. 1, and is the figure which shows the assembled state of a disposable needle.</figref><figref num="5">It is a figure which shows a part of the injection machine of FIG. 1, and is the figure which shows the assembled state of a disposable needle.</figref><figref num="6">It is a figure which shows a part of the injection machine of FIG. 1, and is the figure which shows the assembled state of a disposable needle.</figref><figref num="7">It is a figure which shows a part of the injection machine of FIG. 1, and is the figure which shows the assembled state of a disposable needle.</figref><figref num="8">It is a figure which shows a part of the injection machine of FIG. 1, and is the figure which shows the assembled state of a disposable needle.</figref><figref num="9">It is similar to FIGS. 4 to 8 and is a figure which shows how to remove a needle from the injection instrument of 1st Embodiment of this invention.</figref><figref num="10">It is similar to FIGS. 4 to 8 and is a figure which shows how to remove a needle from the injection instrument of 1st Embodiment of this invention.</figref><figref num="11">It is similar to FIGS. 4 to 8 and is a figure which shows how to remove a needle from the injection instrument of 1st Embodiment of this invention.</figref><figref num="12">It is a block diagram which shows the operation of the control unit which controls an injection instrument of FIG.</figref><figref num="13">It is a front view of the injection machine of the 2nd Embodiment of this invention, and is the figure which shows the state which the front wall was removed so as to show the inside of this injection machine.</figref><figref num="14">It is a front view of the injection machine of the 2nd Embodiment of this invention, and is the figure which shows the state which the front wall was removed so as to show the inside of this injection machine.</figref><figref num="15">FIG. 5 is a cross-sectional view of the inside of the injection machine of the second embodiment, showing one of two different positions of the push member of the injection machine.</figref><figref num="16">FIG. 3 is a cross-sectional view of the inside of the injection machine of the second embodiment, showing the other of the two different positions of the push member of the injection machine.</figref><figref num="17">It is sectional drawing which shows the end of the needle and the cartridge inserted into the injection instrument of 2nd Embodiment in the disassembled state.</figref><figref num="18">FIG. 5 is a cross-sectional view showing an assembled state of an end portion of a needle and a cartridge inserted into the injection device of the second embodiment.</figref><figref num="19">It is sectional drawing which shows the method of connecting a needle to a cartridge.</figref><figref num="20">It is sectional drawing which shows the method of connecting a needle to a cartridge.</figref><figref num="21">It is sectional drawing which shows the method of connecting a needle to a cartridge.</figref><figref num="22">It is sectional drawing which shows the method of connecting a needle to a cartridge.</figref><figref num="23">It is sectional drawing which shows the method of removing a needle from a cartridge.</figref><figref num="24">It is sectional drawing which shows the method of removing a needle from a cartridge.</figref><figref num="25">It is sectional drawing which shows the method of removing a needle from a cartridge.</figref><figref num="26">It is a figure which shows the inner part of the injection instrument of the 2nd Embodiment which includes the sensor means which detects the connection state of the needle to a cartridge.</figref><figref num="27">It is a figure which shows the inner part of the injection instrument of the 2nd Embodiment which includes the sensor means which detects the connection state of the needle to a cartridge.</figref><figref num="28">It is a figure which shows the inner part of the injection instrument of the 2nd Embodiment which includes the sensor means which detects the connection state of the needle to a cartridge.</figref><figref num="29">It is a figure which shows the inner part of the injection instrument of the 2nd Embodiment which includes the sensor means which detects the connection state of the needle to a cartridge.</figref><figref num="30">It is a figure which shows another sensor means which detects the connection state of the needle to a cartridge.</figref><figref num="31">It is a figure which shows another sensor means which detects the connection state of the needle to a cartridge.</figref><figref num="32">It is a front view of a part of the injection instrument of the 2nd Embodiment including a door opening mechanism body and a door lock mechanism body in the 1st form, and shows the state which some parts were omitted for easy understanding. It is a figure.</figref><figref num="33">It is a side view of a part of the injection instrument of the 2nd Embodiment including a door opening mechanism body and a door lock mechanism body in the 1st form, and shows the state which some parts were omitted for easy understanding. It is a figure.</figref><figref num="34">It is a partial excision view of a part of the injection device of the second embodiment including the door opening mechanism body and the door lock mechanism body in the first form, and the state where some parts are omitted for the sake of clarity. It is a figure which shows.</figref><figref num="35">It is a front view of a part of the injection instrument of the 2nd Embodiment including a door opening mechanism body and a door lock mechanism body in the 2nd form, and shows the state which some parts were omitted for easy understanding. It is a figure.</figref><figref num="36">It is a side view of a part of the injection instrument of the 2nd Embodiment including a door opening mechanism body and a door lock mechanism body in the 2nd form, and shows the state which some parts were omitted for easy understanding. It is a figure.</figref><figref num="37">It is a partial excision view of a part of the injection device of the second embodiment including the door opening mechanism body and the door lock mechanism body in the second form, and the state where some parts are omitted for the sake of clarity. It is a figure which shows.</figref><figref num="38">It is a front view of a part of the injection instrument of the 2nd Embodiment including a door opening mechanism body and a door lock mechanism body in the 3rd form, and shows the state which some parts were omitted for easy understanding. It is a figure.</figref><figref num="39">It is a side view of a part of the injection instrument of the 3rd Embodiment including a door opening mechanism body and a door lock mechanism body in the 3rd form, and shows the state which some parts were omitted for easy understanding. It is a figure.</figref><figref num="40">It is a partial excision view of a part of the injection device of the second embodiment including the door opening mechanism body and the door lock mechanism body in the third form, and the state where some parts are omitted for the sake of clarity. It is a figure which shows.</figref><figref num="41">It is a block diagram which shows the operation of the control unit which controls an injection instrument of 2nd Embodiment.</figref>

Preferred non-limiting embodiments of the present invention will be schematically illustrated with reference to the accompanying drawings.

Reference numeral 1 in FIG. 1 indicates a handheld electronically controlled injection device that injects a liquid drug as a whole and, in particular, performs a completely automatic subcutaneous injection.

The injection device 1 is essentially a handheld housing 2 with a seat 3 that receives a cartridge 4 containing a liquid drug, and is housed inside the housing 2 and works with the cartridge 4 to be pre-configured for the patient. An injection drive unit 5 (FIGS. 2 and 3) that is selectively actuated to inject a different dose of drug, and an electronic control that can also be housed inside the housing 2 and controls the operation of the injection drive unit 5. It has a unit 6 (FIG. 12), a microprocessor in the illustrated example.

Specifically, the housing 2 in the illustrated example is in the form of a thin prism with an LCD display 8 and a front wall 7 with a setup button 9 (whose operation will be described in detail later). , The posterior wall 10, the two sides 11,12, the bottom wall 15 with the contact surface 16 in contact with the patient's skin, and the top wall 17 with the injection start button 18, which will be described in detail later. Have.

As shown in FIG. 1, one of the side portions (11) of the housing 2 is hinged at the bottom around an axis perpendicular to the front wall 7 and the rear wall 10, and the cartridge 4 can be inserted into the seat 3. It has a door 19 that opens outward to allow it.

In the illustrated example, the seat 3 that receives the cartridge 4 has an axis A perpendicular to the bottom wall 15 and the top wall 17 and is formed near the side portion 11.

The housing 2 has an axis parallel to the axis A near the opposite side portion 12 and receives one or more batteries 21 that electrically power the injection device 1. Further comprising (FIGS. 1-3), these batteries are inserted through another door 22 formed on the bottom wall 15.

As shown in FIGS. 1 to 11, the cartridge 4 is composed of a hollow cylindrical main body 23 containing a predetermined amount of liquid drug, and the hollow cylindrical main body is inserted with a commercially available disposable needle 25 in a known manner. It has a small end 24 with a closed cross section that can be closed and an open opposite end 26 that engages the disc-like member or plunger 27 in a fluid-tight state, the disc-like member or plunger. Operated by the injection drive unit 5, it slides inside the main body 23 and administers the drug through the needle 25.

The cartridge 4 is inserted into the housing 2 with the end 24 for the needle 25 facing the bottom wall 15, and thus facing the contact surface 16 in contact with the patient's skin. It has a through opening 30 on the axis A for attaching and detaching the needle 25 to and from the cartridge 4, and the needle 25 projects through this through opening and injects into the skin.

The cartridge 4 is a known external marker (not shown) for confirming the presence of the cartridge 4 inside the housing 2 and for obtaining information about the drug, such as composition, concentration, expiration date, etc., for example, a barcode of a predetermined pattern. It has a notch, a conductive material or a reflective material. Another possible way to identify the cartridge 4 is to use a high frequency identification system.

As clearly shown in FIGS. 4-6, the needle 25 is supplied in a protective needle housing 31 to prevent trauma to the user and is assembled with the needle housing 31. Consists of solid 32.

Specifically, the needle 25 is fixed to and protrudes from the plastic needle support 33, and the needle support is fitted to the end 24 of the main body 23 of the cartridge 4.

As is known, the needle 25 punctures the patient's skin and has an anterior portion 34 (shown at the bottom in FIGS. 2-11) protruding from the needle support 33 and within the needle support 33. It has a rear end 35 (located at the top in FIGS. 4-11) that is housed in and attached through the end 24 of the main body 23 of the cartridge 4. Specifically, the needle support 33 surrounds the rear end 35 of the needle 25 and has a number of elastic flanges that engage the end 24 of the body 23 of the cartridge 4, as described in detail later. have.

As a variant not shown, it is also possible to reverse the engagement between the needle support and the cartridge end, in which case the cartridge end is elastic to engage the needle support. It is better to have a flange. In this other embodiment, the needle support does not need to be specially designed to have an elastic flange, but a standard commercial needle assembly (and a general commercial version with threads). It has the advantage that it can be used.

The needle housing 31 is composed of a cylindrical cup-shaped main body housing front portion 34 of the needle 25, and the open end portion of the needle 25 is attached to the needle support 33. In the illustrated example, the needle assembly 32 further comprises an inner needle housing 37 that covers the anterior portion 34 of the needle 25.

Referring to FIGS. 2 and 3, the injection drive unit 5 has an electromechanical actuator assembly 40 that is selectively actuated to act on the plunger 27 of the cartridge 4. This is moved toward the end 24 inside the main body 23 of the cartridge 4 to deliver the liquid drug through the needle 25.

According to an important feature of the present invention, the injection drive unit 5 moves the cartridge 4 inside the housing 2 along the axis A toward or from the contact surface 16 to automatically move the needle 25 to the cartridge 4 It has another electromechanical actuator assembly 41 for attaching to and detaching from, and for inserting the needle 25 into the patient's skin at a predetermined speed.

Specifically, the cartridge 4 is fitted with a support sleeve 42 that slides in the axial direction inside the seat 3 of the housing 2.

As shown in FIGS. 2 and 3, the support sleeve 42 is open not only on opposite ends but also on the side facing the door 19 so that the cartridge 4 can be inserted.

Specifically, the support sleeve 42 has a bottom end 38 having a small cross section that receives the end 24 of the cartridge 4, which bottom end of the needle support 33 when the needle 25 is attached to the cartridge 4. Engage with elastic flange 36. The end 38 also constitutes an annular shoulder 39 with the rest of the support sleeve 42.

The actuator assembly 40 acts on the electric gear motor 43, the plunger 27 of the cartridge 4, and moves it toward the end 24 inside the main body 23 of the cartridge 4, and the rotation generated by the gear motor 43. It has a transmission device 45 that converts the above into the translation of the push member 44.

Specifically (FIG. 2), the transmission 45 substantially meshes with the pinion 46 attached to the output member of the gear motor 43, the screw assembly 47 connected to the push member 44, and the pinion 46. It has an intermediate gear 48 with external teeth and internal teeth that engage the internal threads 49 of the thread assembly 47.

Specifically, the lead screw 49 is attached to the housing 2 so that it rotates but does not translate axially, and the screw assembly 47 is attached to the lead screw 49 and is integral with the push member 44, the housing 2 It also has a nut screw 50 that is attached to and translates along the lead thread 49, but does not rotate relative to it.

The push member 44 is advantageously composed of a core of a known Bowden-type flexible cable 51, the sheath 52 of which cable has a portion fixed to a housing 2, eg, a top wall 17.

The actuator assembly 41 is integrated with the electric gear motor 53 and the support sleeve 42 of the cartridge 4, and has a slider 54 that can move parallel to the axis A, and converts the rotation generated by the gear motor 53 into translation of the slider 54. It has a transmission device 55 to be used.

Specifically (FIG. 3), the slider 54 projects laterally from the support sleeve 42, is attached to the housing 2, and is a nut that translates along an axis parallel to axis A but does not rotate relative to it. It is composed of screws. The transmission 55 is connected to the pinion 56 attached to the output member of the gear motor 53 and the slider 54 and attached to the housing 2 and rotates around its own axis, but translates along this axis. It has a lead screw 57 that does not, and an intermediate gear 58 that has external teeth that mesh with the pinion 56 and internal teeth that engage the lead thread 57.

Referring to FIGS. 4-11, the injection instrument 1 has two or more holding elements 60 extending around the seat 3 to keep the needle assembly 32 attached to the housing 2 in place (FIG. 5). In this predetermined position, the needle assembly 32 protrudes from the bottom wall 15 of the housing 2 along the axis A, and the portion with the needle support 33 is an opening provided in the wall 15. Fits in part 30.

Specifically, the holding element 60 comprises a lever extending parallel to axis A and having a free bottom end with a top end 61 and a lock flange 62 hinged to a structural portion of housing 2. ing. Specifically, the lock flange 62 is located at the opening 30 and extends perpendicular to the axis A and inside the opening 30.

The holding element 60 is elastically loaded inward of the seat 3 to take a locked form (FIGS. 5, 6, 10 and 11) and supports when the support sleeve 42 moves along axis A. Each cam profile 63 interacting with the deformed annular protrusion 64 provided on the sleeve 42 separates it into a released or released form (FIGS. 4, 7, 8 and 9).

Specifically, the support sleeve 42 and the cartridge 4 together with the support sleeve 42 are jointly moved by the actuator assembly 41 in opposite directions along the axis A to the following three separate positions, that is, -The top limit position where the cartridge 4 is loaded and some automatic operation of the injection device 1 (in this case, the operation of assembling and disassembling the needle 25 and the operation of injecting the drug into the patient) starts and ends (Fig. 4 and). Figure 7), -Lowest limit position where needle 25 was removed from cartridge 4 (Figs. 10 and 11), -The operating position near the bottom limit position, where the liquid drug is administered through the patient's skin and the needle 25 is connected to the cartridge 4 (Fig. 6). Can be taken.

As shown in FIGS. 4 to 11, the cam profile 63 of each holding element 60 and the protrusion 64 of the sleeve assembly 42 are in the form of complementary ramps and cooperate with each other. The holding member 60 is pulled apart at or near the uppermost limit position of the support sleeve 42, or during the movement of the support sleeve 42, the holding element 60 is elastically returned toward the axis A by separating from each other at other positions taken by the support sleeve 42. Designed to receive only force.

As shown in FIGS. 5 and 6, in the locking form, the locking flange 62 of the holding element 60 places the needle assembly 32 inside the opening 30 of the bottom wall 15 when the support sleeve 42 is moving to the operating position. The end 38 of the support sleeve 42 fits inside the elastic flange of the needle support 33 in cooperation with the outer rib 65 formed at the open end of the needle housing 31 to hold, behind the needle 25. Allow the end 35 to be inserted inside the end 24 of the cartridge 4.

Next, when the support sleeve 42 moves from the operating position to the uppermost limit position, the lock flange 62 of the holding element 60, which is still in the locked form, presses against the needle housing 31 to prevent the needle housing from following the needle 25. , The needle support 33 and the inner needle housing 37 can move together with the support sleeve 42 to automatically connect the needle 25 and the needle support 33 to the cartridge 4 and withdraw from the needle housing 31. It has become.

Notably, the holding element 60 also locks the needle housing 31 to the user when pressed against the needle housing 31. Thus, ultimately, the user's removal of the needle housing 31 is prevented, for example, when the needle 25 is connected to the cartridge 4.

At the bottom limit position of the support sleeve 42 (FIGS. 10 and 11), the lock flange 62 of the holding element 60 enters the gap between the shoulder 39 of the support sleeve 42 and the rear end of the needle support 33, and then When the support sleeve 42 moves to the uppermost limit position, the needle support 33 is restrained and the needle 25 and the needle support 33 are automatically pulled out from the cartridge 4 after use.

Referring to FIG. 12, the control unit 6 receives many signals from various detection elements and buttons provided on the injection device 1 and according to the program stored in the control unit 6 itself, the gear motors 43, 53 and Output the control signal for display 8.

Specifically, the control unit 6 receives the next signal. -Signals S1, from sensors 66 (eg, optical, electrical, high frequency, infrared, etc.) that are facing the seat 3 and detect the markings on the cartridge 4. -A presence sensor 67 that is provided at the opening 30 of the bottom wall 15 and determines the engagement of an outer body of a predetermined diameter with the opening, such as a needle housing 31, such as a signal S2 from a contact installation. -Signal S3 from a skin sensor 68, eg, a mechanical or capacitive sensor, that is located on the bottom wall 15 of housing 2 and determines contact with the patient's skin. -For example, signal S4 from setup button 9 to select injection dose, speed at which the needle 25 penetrates the patient's skin, drug delivery speed, etc. -Signal S5 from injection start button 18.

Based on the incoming signal, the control unit 6 outputs signals C1 and C2 for controlling the gear motors 43 and 53 and signals C3 for controlling the display 8 in both rotation directions.

The control unit 6 stores the operation program of the control unit 6 and the dose and timing of injections to be performed to inform the patient and / or the doctor of these things and how many doses remain in the cartridge 4. It has its own internal memory 70 (shown externally for simplicity). Therefore, the doctor can check the patient's consent.

Injection Instrument 1 is an interface (known and not shown) that allows information to be exchanged with a computer for data analysis, such as a USB port, Bluetooth (Bluetooth®) communication unit, red. It also has an outer port and so on.

Programming of Injection Instrument 1 is also often possible (eg, by uploading from a computer), and this programming may be useful for clinical trials (eg, in certain quantities and at certain times of day /). Allows only injections at intervals).

For example, the operating principle of the injection device 1 in the form of FIG. 4 will be described. In the form of FIG. 4, the support sleeve 42 does not have the needle 25 and is set to the uppermost limit position, and the cartridge 4 has a door. It is inserted into the seat 3 of the housing 2 through 19 and is connected to the support sleeve 42.

Assembling the needle 25 to the cartridge 4 is completely automatically controlled by the control unit 6, and the opening end of the needle housing 31 simply inserts the needle assembly 32 into the opening 30 of the bottom wall 15 of the housing 2. It is carried out by doing. The insertion of the needle assembly is immediately detected by the presence sensor 67, so the control unit 6 moves the gear motor 53 in the design direction via the transmission 55 and the slider 54 to move the support sleeve 42 to the operating position.

As a result of the above-mentioned movement of the support sleeve 42, the protrusion 64 is separated from the cam profile 63, the holding element 60 moves inward of the opening 30, and the lock flange 62 approaches the needle housing 31 and the needle housing 31. Lock in a position that partially engages the opening 30 (Fig. 5).

The needle assembly 32 may be inserted into the opening 30 either by hand or by using an adapter as shown by reference numeral 71 in FIGS. 4-10.

Specifically, the adapter 71 is in the shape of a double cup, which constitutes a cavity with open sides on opposite sides, respectively, to form the needle housing 31 and the inner needle housing 37. It has portions 72,73 located on opposite sides of each other with different diameters to accommodate each. Also, the large portion 72 of the cross section houses the cylindrical slip sleeve 76 that constitutes the actual seat for the needle house jig 31, the function of which will be described later, and the small portion 73 of the cross section is open. It has an inner rib 74 inside close to the end, which is pressed against the inner needle housing 37 to remove the inner needle housing from the assembly composed of the needle 25 and the needle support 33.

When the support sleeve 42 reaches the operating position (FIG. 6), the ends 38 are inserted between the elastic flanges 36 and connected to the needle support 33, and the rear end 35 of the needle 25 is the end of the cartridge 4. Inserted inside 24.

At this point, the rotation direction of the gear motor 53 is reversed, and the support sleeve 42 moves from the operating position to the uppermost limit position. When the support sleeve 42 becomes like this, the needle support 33, the needle 25, and the inner needle housing 37 together with the support sleeve 42 are axially engaged with the opening 30 by the holding element 60 in a state of being partially engaged and locked from the needle housing 31. Pull out.

Near the top limit position, the protrusion 64 of the support sleeve 42 interacts with the cam profile 63 of the holding element 60 to pull the holding element 60 apart, and the lock flange 62 moves outward of the opening 30 to move the needle housing. Try to release 31 (Fig. 7).

Once the support sleeve 42 reaches the top limit position, the portion 73 of the adapter 71 should be inserted through the opening 30 into the seat 3 and the cavity of the portion 73 thus engages the inner needle housing 37. To do. The insertion of portion 73 is not detected by the presence sensor 67, assuming its diameter is small. When the adapter 71 is pulled out of the opening 30, the inner needle housing 37 is removed from the needle 25 (FIG. 8).

Consent to initiate the actual injection is given by the surface 16 coming into contact with the patient's skin and by activating the skin sensor 68. When the start button 18 is pressed, the gear motor 53 is first activated and then the support sleeve 42 is returned to the operating position via the transmission 55 so that the needle 25 punctures the patient's skin. The gear motor 43 is then actuated and acts on the plunger 27 of the cartridge 4 via the electric device 45 and the push member 44 to slide the plunger towards the end 24 and deliver a predetermined dose of liquid drug.

Prior to injection, the dose to be injected, the rate at which the needle 25 punctures the patient's skin, the rate at which the liquid drug is delivered and the injection depth are selected using the setup button 9 and displayed on the display 8. Is good.

Once the injection is complete, the support sleeve 42 returns to the top limit position.

Cartridge needle 25 completely automatically with adapter 71 (FIGS. 9 and 10) or directly with needle box 75 (FIG. 11) of the form known, for example, by the trade name "SHARPS BOX" 4 It is better to remove it from. Specifically, when using the adapter 71 used to remove the needle housing 31 and the inner needle housing 37 (FIGS. 9 and 10), the slip sleeve 76 is first pulled out of the portion 72, which is the needle housing 31. Must rest axially on the rib 65 of the.

At this point, the needle housing 31 and the extracted slip sleeve 76 are inserted through the opening 30 of the housing 2 to activate the presence sensor 67, and as a result, the control unit 6 operates and supports the gear motor 53. The sleeve 42 is moved from the uppermost limit position to the lowermost limit position.

When the cam profile 63 is disengaged from the protrusion 64 of the support sleeve 42, the retaining element 60 is prevented from moving into the locked form because the lock flange 62 rests on the slip sleeve 76 of the adapter 71 (FIG. 9). ..

However, when the support sleeve 42 reaches the bottom limit position (FIG. 10), the lock flange 62 of the holding element 60 is placed in the gap between the shoulder 39 of the support sleeve 42 and the axial apex of the needle support 33. Makes a clicking sound.

At this point, when the rotation direction of the gear motor 53 is reversed, the support sleeve 42 moves to the uppermost limit position. When the support sleeve 42 is in this way, the needle support 33 and the needle 25 are held by the lock flange 62 and thus remain in a position where they are axially pulled out from the support sleeve 42 and the cartridge 4.

When the support sleeve 42 reaches the top limit position, the holding element 60 is pulled apart again, and the injection instrument 1 is ready to be fitted with another needle 25 for the next injection.

When using the needle box 75 (FIG. 11), simply insert the mouth end of this needle box located inside the opening 30 to activate the presence sensor 67 and the needle 25 exactly as described above for the adapter 71. Automatically remove from cartridge 4 in the same way.

The advantages of the injection device 1 of the present invention will be clear from the above description.

In particular, by allowing control of the movement of the cartridge 4 to and from the contact surface 16, the injection device 1 can completely automatically attach and detach the needle 25 to and from the cartridge 4, and the needle 25 can be used by the patient. The speed of puncturing the skin can be controlled.

In other words, when making an actual injection, it is possible to set not only the drug dose and dose delivery rate, but also the rate at which the injection 25 protrudes from the housing 2 and thus the skin puncture rate.

However, it is clear that the modifications of the injection instrument 1 described herein can be made without departing from the scope of the invention described in the claims.

In particular, a single gear motor can be used to control the movement of the cartridge 4 and the delivery of the drug contained within the cartridge 4, which is, for example, a transmission device similar to that described above. Allows you to control the axial displacement of the core of the Bowden-type flexible cable that acts on the plunger 27 of the cartridge 4, and also allows the plunger 27 of the cartridge 4 and the body 23 to be selectively integrated with each other. It is preferable to provide a locking means, and as a result, when the locking means is activated, the cartridge 4 moves back and forth to the contact surface 16, and when the locking means is released, the plunger 27 slides inside the main body 23 of the cartridge 4. Move to send out the drug.

In addition, it can be used in other types of drug containers, such as syringes, in the same manner as disclosed Syringe 1.

13 to 16 show a handheld electronically controlled injection device 80 according to a second embodiment of the present invention. Similar to the injection device 1 of the first embodiment, the injection device 80 shown in FIGS. 13 to 16 is designed to act on the cartridge holder 82 that receives the cartridge 83 containing the liquid drug and the plunger 85 of the cartridge 83. The push member 84, the first mechanical actuator assembly 86 that drives the push member 84, and in particular the second electromechanical actuator assembly 87 that moves the cartridge holder 82 in the axial direction are housed 81 (FIG. 13). And (shown only in Figure 14). The door 88, which is provided on the side wall of the housing 81 and is actuated by the sliding motion button 89 provided on the same side wall, can be opened by rotating it around the rotation axis 90, thereby injecting the cartridge 83 into an injection instrument. Can be taken in and out of. The cartridge holder 82 can move axially with respect to the door 88 when in the axially retracted position, but can rotate around the rotation axis 90 with the door 88.

The push member 84 is in the form of a spring and is axially incompressible and laterally flexible, offset by 180 ° by a guide-rigidity semi-circular housing 92 provided at the top of the injection instrument. The tube 91 and the piston 93 fixed to the end of the tube 91 protruding from the housing 92 along the axis B of the cartridge holder 82 and the cartridge 83. The piston 93 is designed to work with the plunger 85 (see FIG. 16) and the movable recess 94 (see FIG. 15) of the cartridge 83, the function of which the movable recess will be described later.

Under the control of the control unit 95 shown in FIG. 41, the first actuator assembly 86 places the push member 84 in the recessed portion 94 (FIG. 15) with the piston 93 located outside the cartridge 83. From the retracted position, it can be moved axially towards the disposable needle 96 connected to the cartridge 83, so the piston 93 contacts the plunger 85 in the cartridge 83 and pushes the plunger 85 to push the needle 96 (FIG. 16). ) To send out the drug. The push member 84 should then be returned to its retracted position, after which the plunger 85 remains in the position where it was pushed.

The second actuator assembly 87 is controlled by the control unit 95 to move the structure consisting of the first actuator assembly 86, the push member 84, the push member housing 92 and the cartridge holder 82 along the axis B, that is, of the patient. The needle 96 is automatically attached to or removed from the cartridge 83 by moving back and forth to the bottom wall 97 of the instrument housing 81 that is in contact with the skin, and the needle 96 is inserted into or removed from the patient's skin. More specifically, the needle 96 connecting the structures 82,84,86,92 to the cartridge 83 is located in the instrument housing 81 at the top retracted position and the needle 96 is provided on the bottom wall 97 through. It can be moved between one or more bottom positions protruding from the opening 98.

With reference to FIGS. 17 and 18, the needle 96 protrudes from the plastic needle support 99 in a fixed state, and the needle support is fitted to the bottom end 100 of the cartridge holder 82 and has a bottom. The corresponding bottom end 83a of the cartridge 83 surrounded by the end 100 is pierced by the rear end 101 of the needle 96. The fitting of the needle support 99 to the cartridge holder 82 is fixed to the bottom end 100 of the cartridge holder 82 and is achieved by an intermediate metal member 102 with a large number of elastic flanges 103, which are the elastic flanges of the cartridge. Within the groove 82a provided in the holder wall, compression is possible between the outer circumferential wall of the bottom end 83a of the cartridge 83 and the inner circumferential wall of the needle support 99.

Prior to connecting the needle 96 to the cartridge 83, the needle support 99 is placed with the needle 96 in a protective needle housing or needle cap 104 and together with the needle 96 needle assembly 105 (see FIGS. 19 and 20). ) Is formed.

With reference to FIGS. 19 and 20, the injection device 80 of this second embodiment further has a releasable holding means for holding the needle assembly 105 in place within the opening 98 of the bottom wall 97. These releaseable holding means include two or more releaseable holding tabs or fingers 106 activated by the needle assembly 105 when the needle assembly 105 is inserted into the opening 98, and the opening 98. It has an axial contact surface 107 that limits the degree of insertion of the needle assembly 105 into the interior. The releaseable holding tab 106 is provided around the opening 98 and receives an elastic load applied to the axis B. The releaseable holding tab 106 forms a gap with the abutting surface 107, which fits with the annular upper flange 108 of the needle housing 104 to lock the needle assembly 105 into the opening 98. An electromechanical sensor (electric switch) 109 (FIG. 41) connected to the releaseable holding tab 106 detects the operation of the tab 106 by the needle housing 104 and sends an electrical signal to the control unit 95.

The automatic connection of the needle 96 to the cartridge 83 is triggered by the insertion of the needle assembly 105 between the tabs 106. Upon this insertion, which is immediately detected by the sensor 109, the control unit 95 activates the second actuator assembly 87 to lower the structures 82,84,86,92 from its retracted position inside the instrument housing 81. The holding force exerted on the needle housing 104 by the holding tab 106 is sufficient to ensure that the needle housing 104 remains locked in its position as shown in FIG. 20, during which the cartridge body with the intermediate fixing member 102 is provided. The bottom end 100 of 82 engages the needle support 99 (FIG. 21). Once the movable structure 82,84,86,92 has reached a predetermined bottom position where the bottom end 100 of the cartridge holder 82 fully engages the needle support 99 and thus connects the needle 96 to the cartridge 83. The second actuator assembly 87 returns the structure 82,84,86,92 to its top retracted position with the needle support 99 and needle 96 connected to the cartridge 83, while the needle housing 104. Is held by the contact surface 107 (FIG. 22).

Unlike the holding element 60 of the first embodiment, the holding tab 106 does not prevent the user from removing the needle housing 104 while connecting the needle 96 to the cartridge 83. However, it does not prevent the needle housing 104 from being removed during connection. However, the removal of the needle housing 104 during connection is detected by the sensor 109. In the event of such removal, the control unit 95 immediately stops the coupling process and controls the movable structures 82,84,86,92 to return to their top position. The user is then suggested to initiate a new coupling process via the display screen 110 (FIG. 41) provided on the injection instrument.

To disengage the needle 96 from the cartridge 83, the user inserts the empty needle housing 104 into the opening 98 until the holding means 106,107 and the needle housing 104 are engaged. The activation of tab 106 is detected by sensor 109. As a result, the control unit 95 operates the second actuator assembly 87 to fit the structures 82,84,86,92 into the needle housing 104 (FIGS. 23 and 24) at the bottom position. Lower to. Next, the user activates the needle release button 111 provided on the instrument housing 81 and connected to the control unit 95 to bring the square holding member 112 together with the abutting surface 107 of the needle housing 104 and the annular upper flange 108. It is preferable to move the leg 113 of the holding member 112 inserted in the gap between them in the transverse direction with respect to the axis B to a position (24) located above the upper end of the needle support. Then, with the needle support 99 and the needle 96 held by the holding member 112, the reverse movement is applied to the structures 82,84,86,92, thereby causing the needle support 99 and the needle 96 to be placed in the cartridge holder. Remove from 82 and cartridge 83 (Fig. 25). The user may then disengage the needle assembly 105 from the holding tab 106 and remove the needle assembly from the injection instrument.

According to an advantageous feature of the present invention, the injection instrument is provided with a sensor means for detecting the connection of the needle 96 to the cartridge 83. These sensor means, visible in FIGS. 26-29, are optical transmitters 114, such as light emitting diodes and first and second optical receivers 115,116, fixed to the inner face of the anterior or posterior wall of the instrument housing 81. It has, for example, a photodiode and a reflector 117, such as a mirror, fixed to the rear or front wall opposite the instrument housing 81. The optical transmitter 114 is aligned with and between the first and second optical receivers 115,116 in a direction parallel to the axis B. When the cartridge holder 82, or more precisely the movable structure 82,84,86,92 is in the retracted position and the needle is not connected to the cartridge 83 (FIG. 26), the beam transmitted by the transmitter 114 The first ray 118 that forms part is first reflected by the mirror 117 through the vicinity of the bottom edge 100 of the cartridge holder 82, and secondly through the vicinity of the bottom edge 100 of the cartridge holder 82. The second light beam 119, which reaches the receiver 115 and is transmitted by the transmitter 114, is first reflected by the mirror 117 through near the bottom edge 100, and secondly near the bottom edge 100. Through it reaches the second optical receiver 116. As is clear from FIG. 27, the cross section of the upper portion of the bottom end 100 of the cartridge holder 82 is only partially circular, that is, the bottom end 100 allows the first light beam 118 to pass through. It has a flat side 120 that is truncated. When the needle support 99 is properly connected to the bottom end 100 of the cartridge holder 82 together with the needle 96, the light beams 118,119 are blocked by the needle support 99 (FIG. 29). Thus, the optical receivers 115,116 are no longer optical beams 118, Do not receive 119. This is interpreted to mean that the needle 96 is properly connected to the cartridge 83 by the control unit 95. FIG. 28 shows an intermediate mode in which the needle support 99 and the needle 96 are partially connected to the cartridge holder 82 and the cartridge 83. In this embodiment, the second light beam 119 is blocked by the needle support 99, but the first light beam 118 still reaches the first light receiver 115. This is interpreted by the control unit 95 as meaning that the needle 96 is only partially connected to the cartridge 83.

Thus, after the needle coupling process described above, if the control unit 95 determines that the needle is not coupled to the cartridge 83 or that the needle is only partially coupled to the cartridge 83, the user initiates an injection. It is not allowed and it is proposed to restart the needle connection process. Thus, the safety of using the injection instrument is improved.

30 and 31 show another sensor means for detecting the connection of the needle 96 to the cartridge 83. In this modification, one 103a of the elastic flanges 103 of the intermediate fixing member 102 is longer than the other. When the cartridge holder 82 is in the retracted position and the needle 96 is properly connected to the cartridge 83, the longest elastic flange 103a that is compressed between the needle support 99 and the bottom end 83a of the cartridge 83 is the needle. It has an outwardly protruding end of the support 99 and forms a first angle α1 with the axis B. In this embodiment, the light beam transmitted by the light transmitter 121 is reflected by the protruding end of the flange 103a and directed to the light receiver 122. The reception of the signal by the optical receiver 122 is interpreted by the control unit 95 as meaning that the needle 96 is properly connected to the cartridge 83. On the other hand, if the needle 96 is not properly connected to the cartridge 83 as shown in FIG. 31, the protruding end of the flange 103a forms a second angle α2, unlike the axis B and the first angle α1. In this case, the light beam reflected by the protruding end of the flange 103a is not received by the light receiver 122. This is interpreted by the control unit 95 as meaning that the needle is not connected to the cartridge 83 or that the needle is improperly connected to the cartridge 83.

Referring back to FIGS. 15 and 16, the delivery of the drug through the needle 96 is performed by the piston 93 of the push member 84 pushing the plunger 85 of the cartridge 83, as described above. During this process, the piston 93 and part of the tube 91 are located in the cartridge 83. The piston 93 and tube 91 remain located within the cartridge 83 as long as several doses of the drug remain within the cartridge 83. Once all doses of the drug contained in the cartridge 83 have been injected into the patient's body, the push member 84 is retracted out of the cartridge 83 to allow the cartridge to be replaced (FIG. 15). However, between two injections, there may be a risk that the user will open the door 88 and remove the cartridge 83 from the injection instrument while the push member 84 is still located inside the cartridge 83. Such work may seriously damage the push member 84.

To eliminate this risk, the present invention advantageously provides a locking mechanism that locks or unlocks the opening mechanism of the door 88 when the push member 84 is located inside or outside the cartridge 83. ..

Referring to FIGS. 32 to 40, the opening mechanism of the door 88 is fixed to the opening button 89 which can slide in the direction parallel to the axis B and the opening button 89 in the instrument housing 81, and the flange 124 is attached. It has a lockable part 123, a lever 125 actuated by the lockable part 123, and a lock member 126 actuated by the lever 125. The lever 125 is attached to an axis fixed to the instrument housing 81. The lock member 126 is attached to the movable structure 82,84,86,92 at a position opposite to the axis B with respect to the release button 89, and is attached to the movable structure 82,84,86,86 in the direction parallel to the axis B. Provided to slide relative to, 92, the locking member has a recess with a flange 127, which is designed to work with the corresponding flange 128 of the cartridge halter 82. ..

The locking mechanism has a movable recessed part 94 and a lever 129 actuated by the recessed part 94 and having a flange 130 at one end, the flange cooperating with the flange 124 of the lockable part 123. Designed to do. The lever 129 is attached to an axis fixed to the instrument housing 81. The recessed part 94 can move along axis B and is fixed to one end of a spring 131 (visible in FIGS. 13-16), the other end of which is a movable structure 82,84, It is fixed at 86,92.

The operating principle of the opening and locking mechanism is as follows. That is, during injection of the drug dose (FIGS. 32 to 34), the movable structures 82,84,86,92 are at the bottom position, and the piston 93 of the push member 84 is located inside the cartridge 83 and is recessed. The part 94 is in the resting position and is in non-contact with the lever 129. In this embodiment, the flange 130 of the second lever 129 engages the flange 124 of the lockable part 123 (FIGS. 33 and 34), locking the lockable part 123 and the release button 89 with it. That is, they cannot be moved up, thus preventing the door 88 from being opened. Between two injections using the same cartridge 83, the movable structure 82,84,86,92 is in its retracted position and the piston 93 of the push member 84 is located in the cartridge 83 and is a recessed part. No. 94 is in the resting position and is in a non-contact state with the lever 129 (FIGS. 35 to 37). In this embodiment, the flange 130 of the second lever 129 still engages the flange 124 of the lockable part 123 (FIG. 37), and the lockable part 123 and the release button 89 with it remain locked. Thus, the door 88 is prevented from being opened. Once all the drug doses contained in the cartridge 83 have been injected, the movable structure of the pusher member 84 82,84,86, The 92 and the piston 93 are retracted, respectively. While retracting the push member 84, the piston 93 enters the recess of the recessed component 94 and pushes the recessed component 94 upward against the action of the spring 131, with the recessed component 94 opposite the end with the flange 124. The lever 129 is rotated in contact with the end of the second lever 129, thus disengaging the lever 129 from the lockable part 123 (FIG. 40). The door open button 89 should then be slid upwards as shown in FIG. By moving the release button 89 upward, the first lever 125 rotates to lower the locking member 129 and thus disengage the flange 128 of the cartridge holder 82 from the flange 127 of the locking member 126. Next, under the action of the spring, the door 88 and the cartridge holder 82 rotate around the rotation axis 90 to enable the cartridge 83 to be taken out from the cartridge holder 82 (FIG. 38). The door opening button 89, the lever 125, the locking member 126 and the lever 129 are affected by their respective springs, which keep them in their dormant positions as shown in FIGS. 32-34 or 35-37. Tend to do.