Medication injector apparatus with drive assembly that facilitates reset

The present invention relates to a drug release device and, in particular, to a portable drug release device such as an injection pen.

Patients with various illnesses, such as diabetes, often have to inject themselves with drugs such as insulin solutions. Various instruments widely known as injector pens or injection pens have been developed to allow humans to easily and accurately self-manage the proper dosage of a drug.

To allow a person to manage the proper dose, the injection pen is equipped with a wide range of doses and injection mechanisms that allow special doses to be easily selected and administered. Generally, these pens are equipped with a plunger and a cartridge containing multiple doses of liquid drug. The drive member is movable to advance the plunger in the cartridge, the method of which the contained drug is dispensed from the opposite end of the cartridge, typically through a needle penetrating the stopper at the opposite end. To do. In a reusable pen, the user may remove and dispose of the exhausted cartridge after the pen has been used to drain the drug in the cartridge. Then, in preparation for the next cartridge, the plunger engagement drive member of the pen is reset to its initial position, which is done during manual or automatic mounting of the replacement cartridge and its injection. The pen can be used for the consumption of the next cartridge.

Various assemblies have been used to allow the resetting of the plunger engagement drive member of the reusable injection pen. One known assembly uses a nut that is fixed inside the housing, such as by ultrasonic welding, which is screwed into a drive screw, which when turned extends from the base of the injection pen. Advance the plunger of the cartridge in the retainer mounted on the pen base. The rotation of the drive sleeve screwed into the fixing nut to advance the plunger is achieved by a toothed clutch that is keyed to rotate with the screw, which clutch is the rotating tooth during the operation of the injection mechanism. It meshes with the drive member. The drive clutch, which has a torque transmission relationship with the drive member when the cartridge retainer is attached to the pen base, is spring-loaded so as to separate from the toothed drive member when the cartridge retainer is removed. It is effective in advancing the drive screw and allows the screw to be reset or pushed back into the pen base during the cartridge retainer mounting process, but this assembly is not without defects. For example, due to the relatively large size of the drive clutch, the flywheel effect of the rotating clutch during screw resetting is inconvenient in achieving retracting the screw to the initial priming position of the pen.

Conventional injection pens have a set of mechanisms that generate audible click noise during the injection process. This click noise is intended to inform the user that the pen is under drug control. One known pen uses an injection clicker mechanism, which employs a series of radially protruding leaf springs located around the outer edge of the disc-shaped radial protrusion of the drive sleeve of the injection mechanism. There is. When the injection mechanism of the pen is activated, the drive sleeve rotates, which causes the clutch to rotate, and the clutch is engaged by the teeth extending axially from the radial protrusion of the drive sleeve to the tip side of the pen assembly. It is moved in the axial direction. When this clutch rotates, the drive screw that extends through the drive sleeve and is keyed to it is turned, and this drive screw is screwed through the nut in the pen housing so that it advances axially and the cartridge plan. Move the jar and drain the medicine from the pen. During rotation of the drive sleeve, a radially extending leaf spring located around the radial protrusion of the drive sleeve slides into and out of a recess in the pen housing located radially outside the pen housing, thereby causing injection. Collaborate to produce audible click noise. The leaf spring is designed to prevent reverse rotation of the drive sleeve, which allows unwanted backup of the drive screw when inserted into the housing recess when the drive sleeve stops rotating. While informative, this injection clicker design is not without its flaws. For example, correcting the feel and sound of injection clicks during pen design requires modifications to the molding cavity of the housing. Moreover, the radial protruding leaf spring results in an undesired increase in the total waist circumference of the injection pen.

In another injection pen disclosed in US Pat. No. 5,681,251, the injection clicker is provided with a spring-loaded tip clutch with axially opposed teeth, which clutch is applied to the nut that engages the forwardable lead screw. Are concentrically placed and spline-engaged. A spring that pushes the tip clutch tooth into the housing bulkhead to create audible clicking during injection also pushes the proximal clutch against the driver to create audible feedback during the dose dial. Perhaps functional, but this design is not without its own flaws. For example, the springs used within this injectable audible feedback structure are also used as part of the dial audible feedback structure, thus affecting other potential features such as dial audible feedback and dial torque. The injection audible feedback cannot be replaced or modified by modifying the spring without.

Another limitation of reusable injection pens is that different types of drugs prepared in separate cartridges can be used in the same reusable pen body, so users of injection pens and their various cartridges will be able to use the pen accurately. Care must be taken to ensure use under controlled dose control. A cartridge verification system is already disclosed in US Pat. No. 5,954,700 to assist the user in verifying the drug contained within the cartridge. In that system, the drug-filled cartridge comprises a source of information designed to provide information about the cartridge to an electronic release device, such as an injection pen, on which it is mounted. Although this is informative, the information provided is not necessarily a release device that indicates to the user the actual dose of the drug controlled by the release device, and the occurrence of calculation errors on the part of the user. It is possible and results in inaccurate doses.

Another limitation of one injection pen concerns dose setting. One mechanism disclosed in U.S. Pat. No. 5,509,905 includes switches, which are signal formation when the switches are operated during rotation by the user of the operating head protruding from the pen base. Used for. These signals are used to mathematically form the number of unit volumes set by the user. However, the use of a cam for switch operation results in a significant change in the rotational resistance of the operating head during rotation of the operating head.

Another problem with some existing injection pens is that dosing and pen injection operations are not intuitive to all users. In particular, for some pens, the user must first set the dose of the drug to be released by turning the knob on the pen as indicated by the number on the marked dial fixedly attached to the knob. No, then an axial or thrust force must be applied to move the knob axially to inject the dose. Due to the design structure of a pen, knobs and dials are moved axially away from the pen base during dose setting, and the knobs and dials rotate into the pen base when plunged during injection. It provides a continuous indication of the amount of drug residue that should return and be radiated through the markings, allowing the user to believe that the return of rotation of the extension knob to the proximal side will inject the drug. However, such beliefs are false in at least one pen structure, and therefore users operating under such false beliefs may not be able to properly self-manage the desired drug.

In the well-known disposable injection pen structure, the dose is set by the rotation of a knob that is also connected to a number-marked dial, and the dial is transitionally projected during rotation. While the dial is turned, a series of spirally arranged numbers on the dial are visible through the window, which indicates the dose to be released from the pen. In this structure, the thrust force causes the knobs and dials to move axially without rotating to inject the dose. However, although advantageous, this structure is not without its flaws. For one thing, during plunge, a small, if any, dose display is sprayed during the setting of the pen, which can be confusing for some users. In addition, after the pen has been used for injection, the dial must be reset before it can be twisted outward for the next radio dose setting. Resetting requires turning the dial to the zero position, except for a limited number of pre-injected doses, followed by an axial shift of the dial.

In this way, it is desired to provide an instrument or method that overcomes one or more of these and other glitches of the prior art.

Outline of the invention

The present invention includes a drive assembly that can advance the plunger of a cartridge in a portable injection assembly, such as an injection pen, which can be reset with minimal effort during replacement of a depleted cartridge. ..

The invention also includes an assembly within a portable injection device, which provides the user with an audible indication of operation during dose injection, which is easily adjusted by the manufacturer, for example by exchanging urging elements. It is possible.

The present invention also includes a therapeutic dose display device for drug radiating devices such as injection pens, which first determine the therapeutic dose based on the sensed drug concentration (concentration). Second, determine the dose setting and then display to see the determined therapeutic dose. The present invention further includes a dose confirmer for the injection pen, which is used by the user during pen setting for dose control using a sensor such as with electrical contacts to read the matrix. Determine how the dose setting mechanism is rotated.

The invention also includes a drug injection device with an assembly for selectively turning the drive sleeve, which has a dial to turn during dose setting and moves inward without rotation during dose injection. To do. The dial is keyed to the barrel in the device and further screwed into the drive sleeve, which is operably connected to the drive member to forward pressurize the drug from the fluid container in the device. There is. The relative rotation experienced by the barrel and drive sleeve during dose setting and injection is used by the electrical sensing mechanism to recognize the placement of the device, which is the dose selected for the user and the residue to be injected. For the amount of injection.

In one embodiment, the invention comprises a resettable cartridge plunger-driven assembly of the dose injection mechanism of a drug injection device, the injection device having a reusable base and a cartridge assembly that can be attached to it. doing. The base has a rotatable drive assembly of the dose injection mechanism in its housing, the cartridge assembly has a drug-filled cartridge, which cartridge has a movable plunger at one end and an outlet at the other. .. The drive assembly includes nuts, screws, drive clutches and urging elements. The nut is keyed to the base housing so that it is movable with respect to the housing between the first and second axial positions and is non-rotatable with respect to the housing at the first and second axial positions. The thread has an external thread that is threaded into the plunger engagement tip and the internal threaded opening of the nut. The drive clutch is axially held and rotatably connected to the nut. The drive clutch is keyed to the screw so that it cannot rotate and is movable in the axial direction. The nut is axially movable from a first axial position to a second axial position within the base housing by engagement with the cartridge assembly during mounting of the cartridge assembly on the reproducible base. The drive clutch is in a torque transmission engagement state with the rotatable drive member when the nut is located in the second axial position, whereby the rotation of the drive member during operation of the dose injection mechanism rotates the drive clutch and it. Rotates the nut so that it causes axial movement toward the tip of the screw, which advances the plunger engaging tip of the screw and pushes the drug out of the cartridge outlet. The urging element urges the nut from the 2nd axial position to the 1st axial position when the cartridge assembly is not mounted against the reusable base. The drive clutch is disengaged from the torque transmission engagement with the rotatable drive member when the nut is placed in the first axial position, thereby engaging the screw plunger.

In another embodiment, the invention comprises a resettable cartridge plunger-driven assembly of the dose injection mechanism of a drug injection device, the injection device being a reusable base and a cartridge that can be attached to the base. Has an assembly. The device base has a rotatable drive assembly of the dose injection mechanism in its housing, the cartridge assembly has a drug-filled cartridge, which cartridge has a movable plunger at one end and an outlet at the other end. ing. The drive assembly includes nuts, screws, drive clutches and urging elements. The nut is keyed to the base housing so that it is movable with respect to the housing between the first and second axial positions and is non-rotatable with respect to the housing at the first and second axial positions. The thread has an external thread that is threaded into the plunger engagement tip and the internal threaded opening of the nut. The drive clutch is keyed to the screw so that it cannot rotate and is movable in the axial direction. The nut is axially movable from the 1st axial position to the 2nd axial position within the base housing by engagement with the cartridge assembly during mounting of the cartridge assembly on the reusable base. .. The drive clutch is now shifted from the rotatable drive member and non-torque transmission engagement position to the rotatable drive member and torque transmission engagement state when the nut is moved from the 1st axial position to the 2nd axial position. The configuration is arranged so that the rotation of the drive member during the operation of the dose injection mechanism turns the drive clutch and thereby the screw through the nut so that there is axial movement towards the tip, thereby causing the screw. Advance the plunger engagement tip to push the drug out of the cartridge outlet. The urging element is configured to urge the drive clutch from the torque transmission engagement position with the rotatable drive member to the torque non-transmission engagement position with the rotatable drive member, and the cartridge is a reusable base. When not mounted on the nut from the 2nd axial position to the 1st axial position

In that alternative embodiment, the invention provides an injection clicker assembly of a drug injection device, which can advance apical to shift the cartridge's movable plunger to push the drug out of the cartridge outlet. A drive screw, a drive sleeve of a dose injection mechanism that can rotate in the first direction within the housing of the device, and the drive sleeve have a longitudinal hole extending through the tip surface and inside of the drive screw, and drive. It comprises a clutch coupled to a screw, which is turned by meshing with the tip surface of the drive sleeve, thereby turning and advancing the drive screw through the nut in the housing. The injection clicker assembly embraces a collar, which is concentrically located on the drive sleeve located at the base of the distal side surface of the drive sleeve. This collar is axially movable and non-rotatable to the drive sleeve as it rotates in the first direction. The collar has multiple teeth that extend axially and mesh with the companion teeth of the stop surface, which are integrally formed with the housing of the device and non-rotatably connected. ing. The injection clicker assembly also has a urging element that pushes the collar to mesh with the stop surface. The collar and stop surface are supplementarily formed so that the collar teeth slide over the stop surface teeth while the drive sleeve rotates in the first direction and due to the return force applied to the collar by the urging element. The collar reciprocates axially on the drive sleeve to produce an audible click, which indicates the injection use of the device.

In another embodiment, the invention provides a therapeutic dose display device for a portable drug injection device, the display device comprising an adjustable dose setting mechanism fitted with a replaceable drug container. There is. This device is released by a visible display, a container recognizer that recognizes the concentration of the drug in the container and has a confirmer placed on the container, and an adjustable dose setting mechanism. Visible Day with a dose confirmer to confirm the volume of the drug selected for and a controller configured to determine the therapeutic dose based on the recognized concentration and confirmed volume. Display the therapeutic dose in the spray.

In another embodiment, the invention comprises a dose confirmer for a drug injection device, which is a dose setting mechanism capable of selectively manipulating the volume of drug to be released from the cartridge being held. Has. The dose confirmer is a rotary matrix placed on the first component of the device and a sensor for electrically sensing the rotary matrix, which is the first component during operation of the dose setting mechanism. The rotation matrix data sensed by the matrix sensor is placed on the second component of the device that experiences rotational movement with respect to the sensor, which allows the placement of the dosage setting mechanism to be displayed, and is wired to the sensor. A controller that translates the rotation matrix data sensed by the sensor to determine the amount of drug to be released from the cartridge during injection, and the drug to be released as determined by the controller. Includes a visible display that displays the amount of.

In yet another embodiment, the present invention provides a user of a portable drug injection device with a drug cartridge to display a therapeutic dose, which portable drug injection device is an operable dose for release drug volume selection. It is equipped with a quantity setting mechanism. This method consists of a step of recognizing the concentration of the drug in the cartridge with the cartridge recognizer of the portable drug injection device, a step of confirming the release volume selected with the doseable amount checker of the portable drug injection device, and a portable method. The step of determining the therapeutic dose using the concentration recognized by the controller of the drug injection device and the confirmed selective release volume as inputs, and the therapeutic dose determined on the display of the portable drug injection device. Includes the step of displaying the amount.

In yet another embodiment, the invention provides a drug injection device, which is a housing and a fluid container mounted on the housing that limits the drug-filled reservoir and has a movable piston at the base end of the reservoir. A needle assembly that is detachably attached to the tip of the fluid container and has an injection needle in the needle assembly that can be circulated with the reservoir, and can be moved forward in the housing. A drive member that pushes the drug out of the container by moving the piston toward the injection needle, and a dose setting element that is outside the housing and can be pushed in from the position where the dose setting element is pushed. It includes a manually rotatable control portion that twists in the first direction, and at the plungeable position, the dose setting element projects further toward the proximal end than the plunge position. The device is also a means that can be actuated by shifting the dose setting element from the plungable position to the plunge position without rotating it in order to advance the drive member towards the tip, the advancing means within the housing. Including drive sleeves and barrels, these are means configured to experience relative rotation during at least some of the movement between the thrust and plunge positions of the dose setting element, and in electronics assemblies. It is equipped with an assembly that displays the dose of the drug to be injected based on the sensing of the relative rotational position of the barrel and drive sleeve.

In yet another embodiment, the invention provides a drug injection device, the device comprising a housing, a drug-filled container mounted on the housing and having a movable piston at one end and an outlet at the other end, and within the housing. It is a drive member that can move forward to the tip side, and is operably connected to the drive member that moves the piston to the outlet side in order to press the drug from the container, and around the drive member and to the drive member. The drive sleeve is a drive sleeve that is rotatable in order to advance the drive member toward the tip side, and is located around the drive sleeve and is engaged with the drive sleeve in the first axial direction. A barrel that is movable from the position to the position in the second axial direction toward the tip side in the housing, and the barrel is rotatable with respect to the housing in the position in the first axial direction and in the position in the second axial direction. A dosage setting element having a non-rotatable barrel with respect to the housing and a manually rotatable portion on the outside with respect to the housing, the dosage setting element being keyed to the barrel within the housing. It is axially movable and non-rotatable with respect to the barrel, and the dose setting element includes a dose setting element that is screwed into the drive sleeve. The manually rotatable portion is rotatable in the first direction, and the dose setting element moves and rotates toward the proximal end along the drive sleeve by screwing with the drive sleeve, whereby the dose is set. The dose setting element is moved from the position where the setting element is thrust to a thrustable position which is further projected from the housing to the proximal end side than the position where the setting element is thrust. When the dose setting element is in a position where it can be thrust, the tip-side force applied to the dose setting element is first transmitted to the dose setting element toward the tip and without rotation, and then the dose setting element. The barrel shifts from the first axial position to the second axial position with respect to the housing.

One advantage of the present invention is that it may provide a drive assembly that facilitates needle reset during mounting of a replacement drug cartridge.

Another advantage of the present invention is that it is possible to provide a drive assembly that allows a urging element that is strong enough to disengage the drive clutch from engagement with the drive member without increasing the injection force of the injection pen during use. This prevents a defect found in prior art in which a weakly urged drive clutch is engaged with the drive member to lock the drive screw and prevent resetting.

Another advantage of the present invention is that it may provide a drive assembly that can limit the flywheel effect during drive screw resetting and in turn reduce the priming volume.

Another advantage of the present invention is to provide a drive assembly that engages the cartridge assembly while mounting it on the pen base to reduce play between the cartridge assembly and the pen base, thereby both. It is possible to provide a drive assembly that can provide an improved fit between and an improved sensation for the injection pen.

Another advantage of the present invention is that it may provide a drive assembly with a relatively simple structure that can reduce assembly and manufacturing costs.

Another advantage of the present invention is that in one embodiment the on-board cartridge is urged forward to hold it in place with respect to the holder's anterior stop member or the retainer of the cartridge assembly for dose release. It is possible to provide a drive assembly that ensures a stable platform for.

Another advantage of the present invention is, in one embodiment, a drive assembly that is urged with the on-board cartridge to limit the relative movement between the cartridge and the drive screw, or otherwise the drooling movement of the pen. Can be provided.

Yet another advantage of the present invention is that an injection clicker assembly is provided that can generate an audible display for the injection operator of a portable syringe equipped with the clicker.

Yet another advantage of the present invention is that an injection clicker assembly is provided, the clicker of which is tuned during the manufacture of the structure, such as by varying the preload of a spring constant or urging element, to provide the desired tone or injection audible feedback. The desired size can be easily provided.

Yet another advantage of the present invention is that an injection clicker assembly is provided, which independently tunes some dialing of audible feedback during manufacture or the torque dialing of the pen mounted therein. It is possible.

Yet another advantage of the present invention is that an injection clicker assembly is provided, which clicker assembly can be designed to act as an anti-backup mechanism for a forwardable drive screw.

Yet another advantage of the present invention is that an injection clicker assembly is provided, which makes good use of space so that it does not adversely impact the length or girth dimensions of the pen on which the clicker is mounted. It is configured and arranged so as to.

Yet another advantage of the present invention is that an injection pen is provided, which can electronically display the dose of a therapeutic agent selected for management by the user by manipulating the dose setting mechanism of the pen. Is.

Yet another advantage of the present invention is that the therapeutic dose administered is medically more important than the number of clicks and the volume of the injection pen unit and is the actual amount of drug to be controlled. You don't have to do a mental calculation of your dose-which is error-prone.

Yet another advantage of the present invention is that an injection pen is provided, the pen can be used for various types of drugs, and the dosage information regarding the particular type of drug in use, such as concentration intensity. Allow injection.

Yet another advantage of the present invention is that the dose that can be sprayed by the injection pen can be determined by the pen after automatic recognition of the concentration of the contents of the on-board drug container.

Yet another advantage of the present invention is that the rotary matrix used to determine the selected dose volume allows the only signal for a small rotation position, such as 15 degrees, of the dose setting mechanism, which is small. It has a compact structure that fits inside the physical cylinder and provides low contact resistance for dose setting so that ease of operation is not compromised.

Yet another advantage of the present invention is that a rotating matrix with the following features is provided, which features an error message immediately if an invalid detected matrix position code should be ignored. Rather than displaying, the device's microcontroller allows it to be determined as a deviation.

Yet another advantage of the present invention is that a drug injection device is provided, which includes an assembly that selectively turns the drive sleeve, which has different modes between dose setting and injection operations, allowing the user to use the device. Allows conceptual identification of different stages of use.

Yet another advantage of the present invention is that a drug injection device is provided, which comprises an assembly that selectively rotates the drive sleeve, which rotates during the dose setting transition, but in the dose injection step. It has a dial that shifts without rotating.

Yet another advantage of the present invention is that a drug injection device is provided, which includes an assembly for selectively turning the drive sleeve, which automatically resets the device to zero during the injection process. Reset to and from that position the dial can be turned for the next release dose set.

Yet another advantage of the present invention is that a drug injection device is provided, which is equipped with a switch used in the housing and for controlling the electronic device of the device, such as setting the date and time values. There is.

Yet another advantage of the present invention is that the switch, which can be equipped within the drug injection device, is activated by the axial movement of the components in the housing during use and serves a discriminating function between taking and injecting operations. Above all, the switch shall be suitable for triggering the final dose memory function of the pen.

The above and other advantages and purposes of the invention, and methods for achieving them, and the invention itself, are made clearer and better by the following description of the embodiments of the invention in connection with the accompanying drawings. Will be understood.

<figref num="1">FIG. 1 is a schematic plan view of a drug injection pen equipped with one form of a dose injection mechanism with a resettable cartridge drive assembly of the present invention.</figref><figref num="2">FIG. 2 is a schematic cross-sectional view showing the injection pen of FIG. 1, showing the drive screw of the drive assembly protruding from the tip of the pen base before mounting the cartridge assembly on the reusable pen base. ing.</figref><figref num="3">FIG. 3 is a schematic plan view of the cross section showing the reusable pen base of FIG.</figref><figref num="4">FIG. 4 is a schematic plan view of the cross section showing the injection pen of FIG. 1 with the cartridge assembly fully attached to the reusable pen base.</figref><figref num="5">FIG. 5 is a perspective view of the drive assembly removed from the injection pen of FIG. 1 and a rotatable drive member that powers the drive assembly.</figref><figref num="6">FIG. 6 is a cross-sectional view of the injection nut and the drive clutch of the present invention in an exploded state.</figref><figref num="7">FIG. 7 is a schematic cross-sectional plan view showing another injection pen, in which the drive assembly of the invention urges the cartridge forward in a retainer that can be attached to the pen base.</figref><figref num="8">FIG. 8 is a partial cross-sectional schematic showing a portion of an injection pen equipped with an injection clicker assembly of one embodiment of the present invention.</figref><figref num="9">FIG. 9 is a partial cross-sectional schematic showing another form of injection clicker assembly of the present invention within another injection pen portion.</figref><figref num="10">FIG. 10 is an exploded perspective view of the injection clicker assembly of FIG. 9 and the portion of the injection mechanism with which it interacts.</figref><figref num="11">FIG. 11 is a perspective view from the opposite side of FIG.</figref><figref num="12">FIG. 12 is a block diagram of one form of the therapeutic dose display device of the present invention.</figref><figref num="13">FIG. 13 is a plan view of an injection pen as a release device equipped with one form of therapeutic dose display device shown in FIG.</figref><figref num="14">FIG. 14 is a cross-sectional view of the cartridge assembly removed from the injection pen of FIG.</figref><figref num="15">FIG. 15 is a plan view of a first embodiment of the barrel hub of the cartridge assembly of FIG.</figref><figref num="16">FIG. 16 is a plan view of a second embodiment of the barrel hub of the cartridge assembly of FIG.</figref><figref num="17">FIG. 17 is a plan view of a third embodiment of the barrel hub of the cartridge assembly of FIG.</figref><figref num="18">FIG. 18 is a schematic view showing how one form of the therapeutic dose display device of the present invention works.</figref><figref num="19">FIG. 19 is a partial cross-sectional plan view of a sensor array and a dial-mounted rotation matrix of one form of the doseable amount confirmer of the present invention.</figref><figref num="20">FIG. 20 is a plan view of the rotation matrix of FIG. 19 that has been rewound and removed from the dose setting dial.</figref><figref num="21">FIG. 21 is a plan view of the sensor array removed from the dial mounting matrix of FIG.</figref><figref num="22">FIG. 22 is a plan view of another embodiment of the doseable amount confirmer of the present invention.</figref><figref num="23">FIG. 23 is a top view of one form of the injection pen of the present invention equipped with an assembly for selectively turning the drive sleeve to inject the set dose.</figref><figref num="24">FIG. 24 is a longitudinal front view of one form of the injection pen of FIG. 23, showing the state before the dose setting knob was manually turned to set the dose to be released by further manipulation of the injection pen. ing.</figref><figref num="25">FIG. 25 is a cross-sectional view conceptually similar to FIG. 24, showing the state after the cap is removed, the pen is primed, and the dose setting knob is turned to the release dose set position. ing.</figref><figref num="26">FIG. 26 is a cross-sectional view conceptually similar to FIG. 25, showing the state after the dose setting knob is slightly pushed in and the pen is mechanically changed to the dose injection state.</figref><figref num="27">FIG. 27 is an exploded rear perspective view of the injection pen of FIG. 23.</figref><figref num="28">FIG. 28 is a front perspective view of the slider assembly of FIG. 27.</figref><figref num="29">FIG. 29 is another rear perspective view of the contact assembly of FIG. 27.</figref><figref num="30">FIG. 30 is a plan view of the rotation matrix of FIG. 27 shown unwound and removed from the rest of the injection pen.</figref>

Corresponding related symbols in various drawings indicate corresponding parts. Although these drawings depict embodiments of the present invention, these drawings should not be measured and certain features are exaggerated within some drawings to better illustrate and illustrate the invention. Or omitted.

FIG. 1 schematically illustrates one type of drug release device for which the drive assembly of the present invention has found beneficial uses. The release device shown is a reusable, lethal injection pen, approximately indicated by 20. As is commonly known in this type of reusable device, the injection pen 20 is equipped with a drug-filled cartridge 22 as part of the cartridge assembly, approximately labeled 24, and this cartridge. Is connected to the reusable pen base, which is roughly shown at 26. The pen base 26 preferably comprises a dose setting and injection mechanism, which is the amount of drug released from the cartridge assembly 24 through the injection needle assembly 27 that is selected and shown to be fitted from it. Works to tolerate. Shown in the embodiment is, knob 28 which is exposed with Kakaido button 30 thereon at the rear or base end of the pen base 26 is a manually operable portion of the dose setting and injection mechanism, other The part is housed in the pen base 26. During the dose setting process, the knob 28 is designed to be rotatable for dose setting, and the knob 28 and button 30 are shown in FIG. 1 when the knob 28 is turned to increase the selected dose. It moves out of the pen base 26 from the axial position shown inside or to the right from the squint in FIG. During the dose injection process that occurs after the dose setting process, when a thrust force is applied to the freely rotating button 30 with respect to the knob 28, the button 30 and knob 28 are shown to the left and in FIG. Designed to shift posteriorly to an axial position, the injection mechanism element contained within the pen base acts on the drug in the cartridge to be injected.

The above is provided as a background and is for illustration purposes and is not limited in any way, as a variant of a syringe having a different dosage setting and injection mechanism and having a different shape and size. Known in the field of injection pen technology. Inventive drive assemblies are also readily applicable to many such drive assemblies in view of the description herein and can be combined with any injection mechanism as an invention drive assembly further theoretically described below. The injection mechanism can rotate a rotatable drive element during the injection process, which inputs a rotational force into the drive assembly. Furthermore, this invention drive assembly is also applicable to automatic syringes with rotatable drive elements and does not require the presence of a dose setting mechanism that allows for various doses to be released.

Further related to FIG. 2, although the mounting of the needle assembly is not shown there, the cartridge assembly 24 is assembled and incorporated from the components in the manufacturing process as the only piece in the unit handled by the user. When the drug is exhausted, it is thrown away. Cartridge 22 of the cartridge assembly 24 comprises a glass housing 32 with an open end, which defines an internal volume filled with a drug such as human growth hormone or insulin. A slidable plunger 34 is liquid-tightly fitted to the inner surface 33 of the cartridge housing. The rod tip 35, which is used to disperse the forward force applied to the plunger 34 and is located on the base end side of the plunger 34 and is movable in the inner volume of the cartridge, is integrated with the tubular collar 38. It has a formed base disk 37, and the tip 121 of the drive screw 120 of the invention drive assembly fits inside the tubular collar. If the rod tip 35 is removed, the tip 121 of the drive screw 120 engages the plunger 34 directly, as opposed to indirectly. Instead, when the pen is to be used with a cartridge without a rod tip, a leg that has a larger diameter than the drive screw and is designed to rotate with respect to the drive screw rotates over the tip 121. It can be mounted so that it engages directly with the cartridge plunger.

The cartridge 22 is further protected by an outer housing 42, which is shown transparent but can be configured separately. At the rear end, the outer housing 42 is externally threaded and has a gradual reduction in diameter neck 44 and a further gradual reduction in diameter rear hub 46, with the rear end of the rod tip 35 extending into the rear hub. ing. The threaded neck 44 allows the cartridge assembly 24 to be screwed or screwed onto the pen base 26. The cartridge assembly 24 has a cap 50, which is fixed during manufacturing by ultrasonic waves or the like to capture the cartridge 22 in the outer housing. The piercing rubber bulkhead 54 is pressed against the cartridge housing 32 by the cap 50 to seal the open front end of the housing. The external screw on the cap 50 allows the needle assembly 27 to be attached. When the assembly 27 is so attached, the rear end of the needle pierces the septum 54, and when the plunger 34 is driven to the left in FIG. 1 during injection use of the pen 20, the drug is cartridgeed through the needle. Squeezed from 22.

The cartridge assembly actuated by the drive assembly of the present invention may have a different structure as is known in the art. For example, and as further shown in FIG. 7, the cartridge assembly is provided as a reusable retainer, which can be connected to the reusable pen base in a suitable manner, such as a screw. Moreover, the retainer internally partitions a chamber in which a cartridge that can be disposed of for use is mounted. After the cartridge internals given by multiple uses of the injection pen are exhausted, the user removes the retainer from the pen base, removes the exhausted cartridge from the open base of the retainer and discards the cartridge. A replacement disposable cartridge is then inserted into the retainer, the cartridge being reconnected to the pen base for use, and this cartridge replacement process can be repeated as needed. In addition, other cartridge assemblies, such as cartridge assemblies that are made of plastic and can be disposed of without an outer protective cover, and include cartridges that mount directly to the pen base, are also available and can be mounted or inserted into the instrument chamber as well. A cartridge assembly containing a removable cartridge, and a cover element for a cartridge receiving device chamber such as a separate cap piece or access door-the access door is slidably or pivotally connected to the device. -Can also be used.

In an additional Figure 3-6, the drive assembly includes a float nut 50 located inside the hollow of the pen base 26 partitioned by the pen base outer housing. In the embodiment schematically shown in FIG. 3, the tip of the pen base outer housing comprises a cartridge interface member 62, which member projects rearward by methods such as gluing, plastic snap-fitting or ultrasonic welding. It is fixed to the housing body part 64. The interface member 62 is threaded inward at a portion 66 for connection to the gradual reduction neck 44 threaded outward, and is mounted on the pen base 26 of the cartridge assembly 24. The external thread 63 of the interface member 62 allows the injection pen 20 to be fitted with a main cap (not shown). Inventive drive assemblies can also be used for other housing structures.

The float nut 60 is integrally molded from plastic and has a generally tubular body portion 70, which is preferably keyed to the pen base housing to allow axial migration of the nut internally. On the other hand, rotation of the nut at any axial position in the housing is prevented. Suitable key retainers include a radially inwardly projecting key 74 located near the rear end of the nut body portion 70, which key is an axially aligned groove or keyway 65 formed within the housing body portion 64. It fits inside. In the illustrated embodiment, three keys 74 are provided at equal angles, but fewer keys may be employed, including additional keys or one key. Further, the nut 60 can be keyed to the pen base housing by a key provided on the housing that fits into a keyway formed on the outer surface of the nut.

The hollow interior 71 of the tubular body portion 70 is bridged by the disc portion 80 of the nut 60. The hollow internal portion arranged on the disk portion 80 side is sized so as to rotatably support the hub 46. The central opening 81 partitioned by the disk portion 80 is provided with an internal thread 82, which is designed to match the external thread 124 of the drive assembly screw 120. A pair of drive clutch retainers 85 is provided on the opposite side of the central opening 81. Each drive clutch retainer 85 is a rim or latch portion 87 that is integrally formed with the body portion 70 and projects inward in the radial direction from the body portion.

The float nut 60 is pushed toward the front end of the pen base 26 by the nut 60 and, for example, an urging element acting between the pen base housings. One suitable urging element is a metal, spiral compression spring 90, which springs on the front end 91, which directly abuts the annular end face 72 of the body portion 70, and the protruding bulkhead 93 of the housing body portion 64. It has a rear end 93 that directly mates. The rear end surface 67 of the interface member 62 provides an axial stop, the front surface 75 of each nut key 74 abuts against this stop to limit the axial forward movement of the nut 60 by the spring 90. There is. Alternative urging elements such as different types of springs and different material structures can also be replaced within other embodiments. The rear end of the urging element may abut against the pen component connected to the housing rather than being integrally formed with the housing.

In the embodiment of FIG. 3, the drive clutch 100 of the invention drive assembly is rotatably and axially fixed to the float nut 60. The drive clutch 100 has a disc-shaped body 102 that is completely surrounded by a snap ring 104 that projects radially outward. When placed as shown in FIG. 6 during the appliance assembly process, moving the drive clutch 100 towards the nut 60 causes the nut and clutch to be slightly retracted until the snap ring 104 passes axially through the rim portion 87. The snap ring 104 elastically deforms into an elastic clutch retainer 85, at which time these pieces bounce back into their original shape and the snap ring 104 surrounds the rim portion 87 and the central opening 81 of the disc portion 80. It is captured in the axial direction between the protruding surface portions 89 of the base end surface. The protruding surface portion 89 has a diameter smaller than that of the tip surface 106 of the drive clutch 100 and provides a smaller contact area for limiting frictional resistance to rotation between them. Other types of latching mechanisms that hold the drive clutch axially within the float nut and allow rotation between them have different numbers of rims or posteriorly protruding cusps that are axially aligned. A portion including a portion in which the latch portion protrudes inward in the radial direction from the pointed portion can be substituted in an alternative embodiment.

The body 102 of the drive clutch 100 comprises a central opening 110 and at least one inwardly extending V-shaped portion or key 112 protruding into the opening. The key 112 fits within the corresponding keyway passage 122 extending longitudinally along the length of the drive or reed screw 120, and the screw comprises an external screw 124 that meshes with screw 82 of the float nut 60. As shown in FIG. 5, the key 112 located on the two diameters fits into the longitudinal keyway 122 located on the opposite side of the drive screw. The engagement of the key 112 and the keyway 122 causes a forced rotation of the drive clutch 100 to rotate the drive screw 120 during injection, and also causes a forced rotation of the drive screw 120 to rotate the drive clutch 100 during resetting. ..

The drive clutch 100 may mesh with the rotatable drive of the injection mechanism for torque transmission. The radial outer region of the proximal surface 113 protrudes in a series of axial directions and includes approximately triangular teeth 114 arranged within the ring, which are configured to fit the similarly shaped teeth provided on the drive member 135. Have been placed. Each tooth 114 includes an inclined side portion 116 and an axially aligned side portion 118, whereas a force is directly applied by the teeth 130 during the drive rotation of the drive clutch 100 by the drive member 135. In alternative embodiments, different torque transfer structures, including friction-utilized flat surfaces for non-slip torque transfer, can replace the tooth structure described above.

The rotatable drive member 135 rotates as the injection pen 20 is operated to expel fluid through the needle assembly 27. The drive member 135 is shown as an annular disk 140 rotatably attached to a sleeve 142 supported within the injection pen, through which a drive screw 120 extends. The annulus 140 comprises teeth 130 protruding forward. The invention drive assembly can be driven by rotatable drive members designed differently within the scope of the invention.

The inventive drive assembly is further understood in light of the following description of the mode of operation of the injection pen 20, which form begins with an injection pen configured as shown in FIG. 2, which is a new cartridge assembly. 24 occurs when it is replaced with a depleted cartridge (not shown). The user first assembles the cartridge assembly 24 onto the pen base 26.

Typically, the user holds the reusable pen base 26 in one hand and the cartridge assembly in the other hand, and then first the tip 121 of the drive screw 120 is inside the hub 46 and rod tip collar 38. Manipulate the components so that they are inserted and in contact with the rod tip base disk 37. The pen base 26 and cartridge assembly 24 are then both axially manually moved, the hub 45 is axially introduced into the hollow interior of the pen base, and the external thread of the gradual reduction neck 44 is first the cartridge interface portion 62. Align with the internal screw 66 of. In the middle of this movement, the rod tip 35 is first further moved into the cartridge 22 to close some space that may exist between it and the plunger 34, and then the drive screw 120 is axially pushed and the float nut. Twist through 60, while the drive clutch 100 spins freely with the drive screw 120 and within the float nut 60. The drive screw 120 is pushed back or reset rather than the plunger 34 being slid into the cartridge 22 due to the relatively low frictional resistance of the drive assembly resetting.

To continue its mounting, the cartridge assembly 24 is rotated relative to the pen base 26 and twisted with the components. During this initial stage of rotation, within the housing internal volume, the annular shoulder 45 is in contact with the end face 76 of the float nut 60 and the float nut is in the anterior axial position due to the urging by the spring 90. In an alternative embodiment, other parts of the cartridge assembly, such as the rear end of the hub 46, may be contacts with the nut 60. Moreover, rather than direct contact or engagement with the nut, the cartridge assembly can be indirectly engaged, such as through an interposition member made of low friction material. As the user continues to twist the cartridge assembly 24, the float nut 60 shifts backwards against the resistance created by the compression of the spring 90. In particular, the shoulder 45 slides along the float nut end face 76 as the cartridge assembly rotates and moves axially, while the nut 60 moves axially without rotating at the same time. The resistance generated by the spring 90, which increases with the insertion stroke, reduces the play between the cartridge assembly 24 and the pen base 26, giving the user a more solid or better constructed injection pen 20. It provides and limits the pen drool that can occur during the relative movement of the cartridge and drive screw.

The cartridge assembly 24 is fully mounted after being twisted until the end face 43 of the barrel 42 abuts against the tip face of the cartridge interface member 62, the arrangement of which is shown in FIG. When the cartridge assembly 24 is so fitted, the nut 60 and the held clutch 100 are in the rear axial position, where the teeth 114 of the drive clutch 100 are non-slip positive with the teeth 130 of the drive member 135. The clutch 100 can be rotated by the rotation of the drive member 135.

Subsequently, and with respect to the injection pen shown in FIG. 1, after the knob 28 has been dialed for dose setting, the press of the button 30 mechanically associated with the sleeve 142 of the drive member 135 is the drive clutch. Turn the drive member 135 to turn 100, thereby driving the screw 120, which twists to advance the plunger 34 through the nut 60 and pressurizes the drug from the needle mounted on the cartridge assembly 24. ..

FIG. 7 schematically illustrates a portion of another injection pen with the drive assembly of the present invention. In this embodiment, the reusable pen base 226 is configured similarly to that shown in FIG. 3, and further this drive assembly has the end 121 of the drive screw 120 added to the leg 123. It is the same as that shown in FIG. 3, except that it is configured to rotatably support. The leg 123 is mounted so as to be rotatable around the axis of the screw 120 during use and to distribute the pressure onto the plunger 34. The cartridge assembly in FIG. 7 is in the form of a reusable retainer 230 with a disposable cartridge, which is similar to the cartridge 22 but lacks the rod tip 35. The retainer 230 may be connected to the pen base housing via a screw or the like, as indicated by 232. The cartridge 22 is inserted into the retainer through a rear end opening that is open when the retainer is not connected to the pen base 226, and is removable for replacement. When the retainer 232 with the fill cartridge 22 is mounted on the pen base 226, the float nut 60 comes into direct contact with the cartridge housing 32 and the spring urging the nut makes the cartridge 22 the front end of the retainer not shown. Pushing forward in the retainer against the inner surface of the. This prevents the cartridge 22 from moving relative to the nut 60.

In another alternative embodiment not shown, the drive clutch does not need to be held by the float nut, but instead simply engages with the drive member by, for example, abutment contact with the float nut. Be shifted. In such a structure, the spring is operably engaged with the drive clutch and urged to disengage from the rotatable drive member when the cartridge assembly is not suitably mounted on the pen base. There is. For example, the front end of the spring abuts the washer member, which holds the drive clutch forward so that it contacts the float nut.

FIG. 8-11 shows the injection clicker assembly of the present invention, which is advantageous for application to injection pens such as the injection pen 20 of FIG. However, although the following description of these assemblies is made in relation to the pen 20 as a whole, such an assembly is not limited to being combined with a pen similar to the pen 20. This inventional injection clicker assembly is also readily applicable for many alternative configured syringes in view of the description below, because the inventional injection clicker assembly described further theoretically below. Can be mounted on the rotatable drive sleeve of the injection mechanism, which is rotated by manipulating the differently constructed components of these injection mechanisms. Moreover, this injection clicker assembly does not require the presence of a dose setting mechanism that allows changes in the amount to be released.

As shown in FIG. 8, one form of the injection clicker assembly of the present invention comprises approximately 240 ring collars or clicker elements. In the following description of the operation of the pen portion shown in FIG. 8, such a pen portion is described as the portion of the pen 20 shown in FIG. 1 for ease of explanation. The pens shown within 8 include, for example, a slightly different drive assembly than those described above in connection with the pens 20, and are also screwed onto the pen base housing and the disposable cartridges contained therein. It should also be appreciated to include a cartridge assembly that includes a reusable retainer 238 that has been used.

The annular collar 240 has a central hole through which the drive sleeve 242 extends and the collar 240 is concentrically mounted on the drive sleeve 242. A slot or keyway 246 in which at least one rib or key, such as a pair of diametrically opposed keys 244, projects inward into the central hole of the collar 240 and extends longitudinally on the opposite side of the drive sleeve 242. It fits slidably inside. Keying the collar 240 to the drive sleeve 242 makes the collar 240 non-rotatable with respect to the drive sleeve 242 but axially movable. In an alternative embodiment, the collar 240 may be keyed to the drive sleeve 242 by the engagement of the keys and keyways provided on the drive sleeve and collar, respectively.

The base end surface of the collar 240 is formed by a ring of teeth 248 extending in the axial direction. Teeth 248 mesh with supplemental teeth 250 formed within the bulkhead 252. The number of colored teeth 248 and the number of teeth 250 that mesh with it need not be 1: 1 because a clicker can remove, for example, every other tooth. The bulkhead 252 is an additional element that spline engages the pen outer housing portion 254, the outer housing is shown as an assembly of composite element parts, and the bulkhead 252 rotates during pen injection use with respect to the pen housing. It is considered impossible. The bulkhead 252 is not axially shiftable in the embodiment of FIG. 8 due to the spring 256 pressurizing the tongue of the pen outer housing. In an alternative embodiment, the mating tooth 250 may be part of a bulkhead integrally formed with the pen outer housing.

The teeth 248 and 250 are formed to allow only one-way rotation with respect to the bulkhead 252 of the collar 240 and therefore the pen housing during engagement. During such relative rotation, the collar teeth 248 produce an audible click noise above the teeth 250. The unidirectional rotation of the collar 240 allows it to act as an anti-backup mechanism for the drive sleeve and injection screw as described below. The anti-backup feature is configured in a different manner in alternative embodiments that do not need to be achieved by the collar 240, teeth 248, 250, so reverse rotation is not blocked and thereby allows bidirectional rotation.

The injection clicker 240 is urged along the drive sleeve 242 to the axial proximal side by an urging element generally labeled 258. In the illustrated embodiment, the urging element is a metal compression coil spring, which is concentrically mounted on the drive sleeve 242, but other types of springs or structural materials may be employed instead. During the injection use of the pen, the spring 258 backs up the collar 240 to provide injection click and rotational positioning. During manufacturing, springs of various strengths can be tested to select springs that provide suitable click noise without changing the bulkhead or color design.

The tip of the spring 258 is in contact with the side surface of the base end of the disc portion 260 protruding in the radial direction of the drive sleeve 242. The distal side of the disk portion 260 comprises an axially projecting ring of teeth 262, which transmit the rotational movement of the drive sleeve to the drive assembly and are used to advance the injection screw. In the illustrated embodiment intended to be illustrated and unrestricted, the drive assembly comprises a clutch 266 with proximal teeth 264, which teeth are complete as the pen is shown in FIG. When assembled in, it meshes with the disc partial teeth 262. The clutch 266 is keyed with an injection screw 270 threaded through a key 268, which key fits into a keyway 272 located on a longitudinally aligned diameter along the screw extending through the drive sleeve 242. ing. The clutch 266 is held axially through the tongue 277 in a floating nut that is generally labeled 275, but is rotatable and the tongue snaps fit onto the clutch during assembly. ing. The floating nut 275 is axially movable with respect to the pen housing, but is keyed to a fixed rotational direction. The floating nut 275 is urged to the tip by a spring 256 when the cartridge retainer 238 and cartridge 22 are disassembled from the pen base, and the drive sleeve tooth 262 is from the clutch tooth 264 to allow resetting of the injection screw. It is designed to come off. When the floating nut 275 moves toward the tip during disassembly of the pen, the drive sleeve 242 is tipped relative to the disc portion 260 by the action of the spring 258 due to the injection mechanism shown in which the drive sleeve is not axially fixed. It is moved to the side, but the floating nut 275 is blocked from engaging the clutch 266 by the engagement of the disc portion 260 with a key (not shown) of the pen housing portion 255 that is keyed.

The injection clicker assembly of FIG. 8 will be further understood in light of the following description of operation within a pen, such as the pen 20. When the pen 20 is in the shape shown in Figure 1 in the ready state before the dose dial for injection, the teeth of the drive sleeve disk portion 260 and the clutch 266 are engaged and the collar 240 and bulkhead 252. Teeth are in mesh as shown in Figure 8. During the dose dial or selection, the spring 258 retains the engagement of the collar teeth 248 with the bulkhead teeth 252. Due to the unidirectional rotation of the collar 240 and the key engagement with its drive sleeve 242, this tooth engagement locks the rotation of the drive sleeve 242. Due to the rotational lock of the drive sleeve assembly, the clutch 266, and thus the drive screw 270 keyed to it, cannot rotate, which provides injection screw anti-backup features. During the thrust of the button 34 in the dose injection step described above, the drive sleeve 242 and the collar 240 keyed to it are rotated in the direction allowed by the tooth profile of the collar 240. The rotation of the disk portion 260 of the drive sleeve 242 turns the clutch 266, and thereby the drive screw 270, which is screwed through the internal screw 279 of the nut 275 to advance the movable plunger of the cartridge 22 forward. Push the drug out of the cartridge outlet. As the collar 240 rotates, it reciprocates axially against the force applied by the spring 258 toward the proximal end, causing its teeth to ride onto the bulkhead teeth 250 and create an audible click, which is injected. Display the operation.

In Figure 9-11, another form of the injection clicker assembly of the present invention is shown within a different injection pen portion. This injection clicker assembly is particularly applied for injection mechanisms with a drive sleeve portion that shifts axially during the injection operation. This injection clicker assembly features a ring-shaped collar or clicker element as approximately 290. The annular collar 290 has a central hole 292 through which the tubular base 335 of the drive sleeve extends. At least one rib or key projects inward in the hole 292, such as a pair of diametrically opposed keys 294. The key 294 fits into a longitudinally extending keyway 340 on the opposite side of the drive sleeve base 335 so that the collar 290 is non-rotatable with respect to the drive sleeve, but is axially movable.

A ring of teeth 296 extending in the axial direction is formed on the base end surface of the collar 290. These teeth 296 mesh with complementary teeth 347 formed within a bulkhead 348 formed integrally with the generally shown pen outer housing.

Each of these teeth 296 has an axial alignment surface 297 and an inclined surface 298 extending with respect to the axial alignment surface of the continuous teeth, and the shape of these teeth allows one-way rotation of the collar 290 with respect to the pen housing. This allows the color to act as an anti-backup mechanism. During such relative rotation, the collar tooth 296 produces an audible click noise as it transitions across the pen housing tooth 347.

The injection clicker 290 comprises a tip surface 300, which is abutted during pen operation by a radially aligned outer region 307 of the retainer ring, generally labeled 305. The ring 305 has a central portion 309 that is tilted forward, which is an interference fit within the circumferential groove 343 formed in the drive sleeve base 335 during pen assembly. This coupling causes the retainer ring 305 to be driven by the axial shift of the drive sleeve base 335 during operation, which is a function of the pen's special injection mechanism. The retainer ring 305 limits the axial movement of the collar 290 when the drive sleeve is present in the axial position shown in FIG. 9, such as the dose dial period, due to the meshing of the outer region 307 and the surface 300. This prevents the collar teeth 296 and the housing teeth 47 from being disengaged.

The collar 290 is urged toward the axial proximal end by a metal coil compression spring 320 concentrically arranged around the drive sleeve body 335. The base end 3221 of the spring 320 fits around the gradual reduction neck 302 of the collar 290. The spring end 321 is pressurized and held by the ribs on six ribs 303 evenly distributed on the outer periphery of the neck.

The tip 322 of the spring 320 fits around the gradual reduction neck 332 of the torque transmission member 330 projecting radially in the drive sleeve as a whole, as indicated by 325. The drive member 330 is a portion of the drive sleeve that transmits the movement of the drive sleeve to the clutch 350 keyed to the drive screw 354. The six ribs 331, evenly distributed around the neck 332, press-contact with the front end 322 of the spring 320 during pen assembly to hold the spring 320 on the drive member 330. The tip side surface of the drive member 330 comprises a tooth 333 that projects axially towards the tip, which meshes with the tooth on the clutch 350 when the pen is assembled for use.

In the embodiment shown in FIG. 9-11, the drive member is a two-part assembly and the radial overhang drive member 330 allows a restriction of axial movement of the drive sleeve relative to the tubular base 335. Shaped so that the base rotates when the pen's injection mechanism is operated. This relative motion capability helps prevent the clutch from binding when the cartridge assembly is mounted on the pen base. In particular, during mounting of the cartridge assembly, the drive member 330 allows the cartridge assembly to be fully mounted without locking up or damaging the clutch teeth when the clutch mechanism encounters tooth-to-tooth. And back up so that the tooth-to-tooth encounter state is retained after the attachment is done automatically during pen priming. The ability of this relative movement also allows axial movement of the drive sleeve tubular base during the injection process, which is a function of the pen's overall injection mechanism.

A pair of diametrically opposed pairs of keys 337 project inward in the radial direction within the central hole 334 of the drive member 330 to which the tubular base 335 fits. The key 337 fits in the keyway 340 extending in the longitudinal direction and cannot rotate with respect to the drive sleeve base 335, but is movable in the axial direction. Opposite snaps or ribs 338 on a pair of diameters also project 90 degrees off-setting from key 337 in hole 334. During the manufacturing and assembly of the drive member 330 with respect to the base 335, the rib 338 snap-fits into a recess 341 formed on the outer circumference of the drive sleeve 335 away from the tip 342. The recess 341 extends axially by a length greater than the thickness of the rib 338 to allow restricted axial movement of the drive member 330 with respect to the base 335. This snap-fit connection prevents the drive sleeve assembly from axially separating when the drug cartridge is disassembled from the pen base, and the forward transfer of the drive member 330 is restricted by the drive sleeve base 335 to assemble the cartridge. When the Lee is removed, the drive member 330 is secured to assist in disengagement from the clutch 350.

The teeth 333 of the drive member 330 mesh with the clutch of the drive assembly used to shift the injection screw towards the tip. The drive assembly shown in FIG. 9 includes a clutch 350 that is internally keyed to a threaded drive screw 354 that extends through the drive sleeve base 335. The clutch 350 is connected to a non-rotatable float nut 360 that is screwed into the drive screw 354. Rotation of the clutch 360 through the drive sleeve 325 turns the drive screw 354, the drive screw is screwed through the nut 360 and the movable plunger 365 of the cartridge 367 is reusable. And push the drug out of the cartridge outlet. The float nut 360 is configured to be urged to the distal end by a spring 369 when the cartridge assembly is removed to disengage the drive assembly from the drive sleeve teeth 333 to allow resetting of the injection screw. This drive assembly is more fully described above. Other drive assemblies with clutches that operably engage the drive sleeve member 330 when the pen is assembled for use may also be used within the device with the injection clicker assembly of the present invention.

The injection clicker assembly of Figure 9-11 will be further understood in light of the following description of operation within the pen. When the pen is assembled as shown in FIG. 9, the teeth 333 of the drive sleeve member 330 and the clutch 350 are in mesh, and the teeth of the injection clicker 290 and the pen housing are in mesh. During the dose dial, the drive sleeve base 335 is held to the proximal side by a spring (not shown) to abut the retainer ring 305 against the collar surface 300 and keep the clicker teeth 296 in mesh with the housing teeth 347. By keying the collar 290 to the drive sleeve base 335, this engagement holds the drive sleeve base 335 and thus the drive member 330 non-rotatably by keying it to the base 335. By locking the drive sleeve assembly non-rotatably, the clutch 350, and thus the injection screw 354 keyed to it, cannot rotate, thereby providing the injection screw with anti-backup features.

If the injection mechanism is manually operated while using dial-up pen injection, the drive sleeve base 335 first moves to the tip side, shifting the retainer ring 305 to the tip side, and the collar 290 has a spring 320. Move to the tip side against the forces. The drive sleeve body 335 begins to rotate, and the teeth 96 of the collar 290 engage and disengage from the housing teeth, resulting in an injection click. The rotation of the drive sleeve also turns the drive clutch 350, which is screwed into the injection screw 354 through the float nut 360. If the float nut floats slightly towards the proximal end during this injection process, the compression spring 369 pushes it towards the tip of the pen to end the injection.

In one embodiment shown in the block diagram in FIG. 12, the therapeutic dose display device of the present invention is housed in a release device 420, and has an automatic container recognizer 422, a dose confirmer 424, and a controller. I am using a 426 and a display 428. One type of release device for which this system is particularly well suited is an injection pen, but other types of portable devices such as lung devices or inhalers can be similarly equipped.

The automatic container recognizer 422 first functions for feature recognition of the inserted container into the ejector 420, the features within one example are about the concentration of the drug in the container, and then that information is shown at 430. Input to controller 426 as follows. The dose confirmer 424 first functions to detect that the dose setting mechanism of the release device 420 has been manipulated by the user to allow the device to release a limited amount of drug, and then 432 that information. It functions to input to controller 426 as shown by. In response to the input information, the controller 426 calculates the therapeutic dose to be released and displays it on the display 428 to visually spray the dose to the user of the release device 420 via line 434. ..

The therapeutic dose-indicating release device of FIG. 12 is shown in FIG. 13 as a reusable injection pen generally called 440. As traditional within this type of reusable device, the injection pen 440 has a cartridge assembly labeled 442 overall, and this cartridge assembly has a pen base labeled 444 overall. Connected to, the pen base houses a dose setting and injection mechanism, and when this mechanism is activated a certain amount of drug is selected and then fired through the needle assembly 467.

One form of cartridge assembly 442 is shown in cross section in FIG. 14, which is similar to cartridge assembly 24 in FIG. 2 and is for confirmation as described below. Thus, the cartridge assembly 442 comprises a cartridge 446 with a glass housing 448, which glass housing limits the drug-filled internal volume. This cartridge is equipped with a slideable plunger 449, a rod tip 452, a cap 464 and a bulkhead 466. The cartridge 446 is further protected by an outer housing or barrel 458, which barrel is equipped with a gradual reduction neck 460 with external threads and a further gradual reduction rear hub 462. The external thread 468 on the cap 464 allows the attachment of the needle assembly 467 through the septum 466.

The automatic container or cartridge recognizer 422 of the injection pen 440 is equipped with a confirmer combined with the cartridge assembly 442, which is designed to work with a sensor, which is a pen based on the detected confirmation. Send a signal to controller 426 in base 444. All of those disclosures are incorporated herein by reference, as described in U.S. Pat. Nos. 5,954,700 and 6110152, and the confirmer can take many forms and vary from user to user. Used to display the facts of.

In one form, the confirmer is used to indicate the concentration of therapeutic inclusions in the cartridge assembly, and the concentration confirmer is located on the outer housing hub 462 of the cartridge assembly 442. The concentration checker retains special features such as dimensional and spatial features, which can be recognized by the sensor of the automatic cartridge recognizer 422. In an alternative embodiment, and in the corresponding modification to the sensor of the automatic cartridge recognizer 422, the recognizer can be placed on the other part of the cartridge assembly, which part includes the cartridge housing 448 and the rod tip 452. Is not limited, and additional separate members are used for display, eg, one of the potentially different insulin types is retained within the cartridge assembly.

The concentration checker is permanently attached to the tubular outer surface of the hub 462. For cartridge recognition systems that sense or read separately a confirmer with elements other than electrical contacts located outside the radial direction, for example, the concentration recognizer is an optical or electromagnetic sensor-based method. In that case, the recognizer does not need to be exposed on the outer circumference of the hub 462 and may be arranged differently so that it is mounted on the inner surface of the hub 462.

As further illustrated in the various embodiments shown and described in connection with FIG. 15-17, the cartridge densitometer is formed by a single strip of conductive material that is fixedly linked to the hub 462. Is shown as. The strip shown extends all around the hub, but if the container recognizer 422 collaborating sensor contacts described below achieve a satisfactory connection despite one or more circumferential gaps in the strip. When it is configured to do so, it may be on only a part of the outer circumference. The conductive strip may be in the form of a pad of conductive ink printed on the hub, but other means of achieving a confirmer strip may also be employed. For example, the strip was applied with a crimped metal band, or a conductive plating material that was inserted and molded into the hub, or conductive paint, or padding ink, or a metallic self-adhesive label, or suitable conductive wiring. It can be a non-conductive adhesive label.

In connection with Figure 15-17, three different cartridge assemblies 442a, 442b and 442c hubs 462a, 462b and 462c, each compatible with the pen base 444, are shown. The type of content checker shown as used on the hubs 462a, 462b and 462c is a conductive strip, along with a spatial aspect of strip placement on the hub for cartridge content indication. Use the dimensional aspect of the width of. This type of content checker has special applicability for hGH concentration confirmation, and this hGH concentration usually has a limited number of concentrations and is therefore shown in Figure 15-17. Each of the three cartridge assemblies holds hGH within different concentrations. In other types of content confirmers within the scope of the present invention, the dimensional aspects of the confirmer strips can differ from the width, such as strip thickness or fabric.

In Figure 15, displaying the first concentration, a conductive strip 472 with a relatively small width, such as about 4.8 mm, surrounds hub 462a of cartridge assembly 442a near the tip of the hub, where it is located in the barrel. Near the threaded neck 460a. In FIG. 16 showing the second concentration, a relatively small width conductive strip 474, such as about 4.8 mm, surrounds hub 462b of second cartridge assembly 442b near the tip of the hub. .. The widths of strips 472 and 474 are the same to reduce the number of parts of different structures required to manufacture various cartridge assemblies, which will be appreciated from the description of instrument operation below, but strips. Different widths for 472 and 474 can also be utilized as long as proper electrical wiring between the sensors is available. Finally, in FIG. 17, which displays the third concentration, a conductive strip 476 with a relatively large width, such as about 7.1 mm, surrounds the hub 462c of the third cartridge assembly 442c and is of the axial length of the hub. It covers almost the whole. The axial region of hub 462c covered by strips 476 is the same as if covered by strips 472 and 474, which is on hub 462c in the same position as those strips were placed on hubs 462a and 462b, respectively. When placed in.

Once one of the cartridge assemblies shown in Figure 15-17 is properly seated to the injection pen 440, such as by screwing the cartridge assembly into the pen body 444 of Figure 13, it is mounted as such. The cartridge assembly content checker provides a conductive passage between a series of sensor contacts in the instrument spaced along the axial length of the inserted hub. The varied widths and positions of the content checkers of the various cartridge assemblies provide different conductive passages between the sensor contacts.

For example, the sensor is equipped with electrical contacts 480, 481 and 482, as outlined in FIG. 18 during operation. Although these sensor contacts are shown in FIG. 18 to be precisely aligned in the axial direction, each of the sensor contacts 480-482 is circumferentially spaced within 60 ° or 120 ° apart. , Or can be angularly separated from other sensor contacts, such as other angular spacing possible within the interior space of the pen base. Further, each sensor contact may include a plurality of contacts that are routed in parallel and located at the same axial hub position. These sensor contacts are, for example, elastic metal fingers protruding from a subassembly base pivoted to the housing, and the circuitry on the base is electrically connected to the circuit board of controller 426. ing. The subassembly base is rotationally urged so that the hub contact portion of the metal finger occupies a radial retracted position when the cartridge assembly is not mounted on the pen base 444. When the hub is inserted into the pen base 444 while the cartridge assembly 442 is connected, the subassembly is passed through the movement of the hub or the movement of moving parts of the base pen that can engage with the hub, such as the float nut described above. The pivot arm of the base is contacted, which rotates the subassembly base so that the contact portion of the finger is moved toward the content checker and the contact side. In an alternative embodiment, the fingers are elastic or leaf spring type metal fingers, rather than pivotable sensor contacts, which are radially inwardly urged to contact the hub and, for example, a pen base housing. Alternatively, they are mounted against moving parts within the housing of the pen base 444 itself, and these fingers slide along the hub as the hub inserts during the connection of the cartridge assembly 442 to the pen base 444.

Controller 426 processes data about the sensor contacts in the injection pen 440 contacting the conductive strip of the content checker and is basically an automatic match to read what is displayed in the cartridge assembly. Extract information from the table. For example, sensor contacts 480 and 482 can be wired directly to controller 426 by lines 484 and 486, and these lines can be a pattern printed on the controller 426 distribution frame. The sensor contact 481 is also wired to controller 426 by line 488, which is grounded at 490. When the cartridge assembly 442b with the content checker 474 is loaded as shown in Figure 18, the grounded sensor contact 481 connects to the checker 474 and the conductivity of the checker 474 is the sensor. Used to ground line 486 to contact 482 and controller 426. Line 484 is not grounded because sensor contact 480 is not connected to confirmer 474. As a result, controller 426 effectively communicates that line 484 remains open while line 486 is closed, and controller 426 loads this input with a certain hGH concentration, such as 12 mg. Shown as equivalent to those present in the cartridge assembly 42b. (Similar to the other hGH concentrations mentioned here, this concentration is displayed as mg units, which is the opposite of the massper volume unit expected in other ways, because the hGH concentration is normal. Referenced, this has been done by physicians for their patients. Such indications are the result of volume figures for the mg indication mass of lyophilized drug prior to undo. , This is the cartridge content as a liquid foam. The concentration in mg / ml display is the relevant milligram mass when restored 2. Easily obtained by dividing by 88 milliliters. ) In a similar manner, when the cartridge assembly 442a with content checker 472 is loaded, the grounded sensor contact 481 is connected to checker 472 and checkered 472 to sensor contact 480 and controller 426. Used to ground line 484, but sensor contacts 482 and line 486 are not grounded, which causes controller 426 to signal that line 486 remains open but line 484 is closed. Equivalents this signal to be present in a cartridge assembly 442a loaded with different hGH concentrations such as 6 mg. Similarly, when the cartridge assembly 442c with content checker is loaded, the grounded sensor contact 481 connects to checker 476, which confirmer 476 is line 484 to sensor contacts 480 and 482 and controller 426. And used to ground the 486, which caused the controller 426 to signal that lines 484 and 486 were closed, and the controller 426 signaled this signal into a cartridge assembly 442c loaded with a different hGH concentration such as 24 mg. Equivalent to exist. Finally, when none of the cartridge assemblies are loaded, or when a cartridge assembly without or with a fault checker is loaded, controller 426 leaves lines 484 and 486 open and provides concentration information. Receives a signal that it cannot be obtained as an input. Equivalent to the presence of different hGH concentrations, such as mg, in the loaded cartridge assembly 442a. Similarly, when the cartridge assembly 442c with content checker is loaded, the grounded sensor contact 481 connects to checker 476, which confirmer 476 is line 484 to sensor contacts 480 and 482 and controller 426. And used to ground the 486, which caused the controller 426 to signal that lines 484 and 486 were closed, and the controller 426 signaled this signal into a cartridge assembly 442c loaded with a different hGH concentration such as 24 mg. Equivalent to exist. Finally, when none of the cartridge assemblies are loaded, or when a cartridge assembly without or with a fault checker is loaded, controller 426 leaves lines 484 and 486 open and provides concentration information. Receives a signal that it cannot be obtained as an input. Equivalent to the presence of different hGH concentrations, such as mg, in the loaded cartridge assembly 442a. Similarly, when the cartridge assembly 442c with content checker is loaded, the grounded sensor contact 481 connects to checker 476, which confirmer 476 is line 484 to sensor contacts 480 and 482 and controller 426. And used to ground the 486, which caused the controller 426 to signal that lines 484 and 486 were closed, and the controller 426 signaled this signal into a cartridge assembly 442c loaded with a different hGH concentration such as 24 mg. Equivalent to exist. Finally, when none of the cartridge assemblies are loaded, or when a cartridge assembly without or with a fault checker is loaded, controller 426 leaves lines 484 and 486 open and provides concentration information. Receives a signal that it cannot be obtained as an input.

It is appreciated that this recognition system has roughly three contact points as shown in Figure 18 and uses a non-grounded recognizable signal such as a small voltage to activate the content checker. It should be. Moreover, as another embodiment of the invention, the cartridge assembly can be in different shapes as known in the art and as described above. In embodiments where a disposable cartridge and a reusable retainer are used, a content checker is provided on the disposable cartridge and the pen base 444 corresponds to allow recognition of that cartridge. Modified, it is done by combining parts of the recognition system with electrical contacts and wiring in the retainer, or by extending pen base components such as contacts into the retainer chamber.

In connection with FIG. 19, an outline of a form of a dose confirmer for the injection pen 440 is shown. The dose checker 424 features a rotatable matrix generally labeled 500 and a sensor array generally labeled 502, which are preferably as well as during dose injection after dose setting. Arranged to confirm adjustment of the pen mechanism used, at least during dose setting. Various dose setting and injection mechanisms are known in the injection pen industry and are therefore not thoroughly described here. Furthermore, since the inventive dose confirmer is readily applicable to such and newly developed mechanisms in view of the description herein, the features of such mechanisms further described herein are illustrated. It is intended and not intended to be limiting. Further, in the most common alternative embodiment of the invention, the known design dose confirmer connected to the controller is a rotary matrix / sensor array within the therapeutic dose indicator of the present invention. Can be replaced with.

The rotation matrix 500 and sensor array 502 are operably connected to the first and second components of the injection pen 440, which are relative during the operation of the dosage setting mechanism by the user to select the desired volume to be injected. Go through a typical rotation.

In the embodiment of FIG. 19, the dose setting mechanism includes a rotatable dial 506 in which a rotating matrix is incorporated. The dial 506 is rotatably attached to the exposure knob 508, which knob can be turned by the user to select the dose to be released by the use of an injection pen. In the embodiments described, dial 506 is turned by knob 508 and moves out of the pen base 444 or to the right from the squint in FIG. 13, which means that the dose is in preparation for injection. Performed during dial-up. However, the matrix of the invention does not have to be on a dial that moves in that way, but rather may be on other rotatable components such as drive sleeves. Further, in the embodiment of FIG. 19, only one of the first and second relatively rotatable pen components is part of the dose setting mechanism, but the other component to which the sensor array 502 is connected. In other embodiments, each of the first and second elements may be part of the dose setting mechanism, as may be the outer housing of the pen base 444.

The matrix 500, which is removed from the dial 506 and shown in two dimensions in FIG. 20, is data arranged in a rectangular array consisting of a plurality of right-angled intersecting columns and columns. The number of columns is the number of functions of the internal work of the injection pen, and corresponds to the number of rotation positions during its rotation, so that the dial 506 becomes an injection pen that releases different volumes of the drug at those locations. Can be set. The movement of the dial 506 between adjacent rotation positions corresponds to changes in the dose unit to be injected by pen operation, and such changes are known as "clicks" by the setting mechanism, which is its Due to its structure that makes audible click noise during such movements. The actual amount of such a dose unit, for example 0.024 ml, is a functional value in the design of the dose setting mechanism as is known in the art.

The data-embedded matrix 500 is in the form of the presence or absence of conductive material at the intersections of columns and columns, and these conductive data points are shown as contacted or all linked to form pattern 501, which pattern is It is configured to be associated with the sensor contacts of the array 502 to carry information to controller 426 of the pen 440. The link allows the electrical signal emitted for a single data point on pattern 501 to travel along the entire pattern, such as grounding at that point, as described below.

Each of the six rows 509, 510, 511, 512, 513 and 514 of the Matrix 500 extends around the entire perimeter of the dial 506. 24 matrix columns 516, 517, 518, 519, 520, 521, 522, 523, 524, 525, 526, 527, 528, 529, 530, 531, 532, 533, 534, 535, 536, 537, 538 And 539 are the same thickness, each separated by 15 ° on the outer circumference of the dial, and they are aligned parallel to the axial length of the dial 506. In the illustrated embodiment, the column 516 is not occupied by any conductive data points and is formed by a circumferential gap between both ends of the conductive pattern portion when the matrix 500 surrounds the dial 506. Otherwise it fills column 509 (ie column 517-539). The 24-column matrix design allows 24 distinct rotation positions of the dial 506 to be recognized. However, less than or more columns than the 24 shown may be provided within the scope of the invention. In addition, a different number of matrix sequences than the six shown can also be used as long as a suitable pattern recognizable by controller 526 is obtained.

The conductive pattern 501 of the Matrix 500 can consist of a measurable material, such as filled styrene plastic, by two-shot molding in a non-conductive or insulating sleeve, the molded material of which is copper, nickel and gold. It can be plated with a conductive material, such as a continuous layer, to form a conductor. After plating, the sleeve is secured to the dial 506. For ease of manufacture, the conductive pattern 501 of the matrix 500 may include a matrix row or an extension (not shown) beyond the column, such as providing the mixing point required for positioning the desired pattern, the extension thereof. The part is not used by the sensor array 502. In an alternative embodiment, the matrix pattern is manufactured in a different way, such as a sheet metal matrix inserted and molded onto a sleeve, or as described above in connection with a cartridge built-in confirmer. It can be, for example, through a non-conductive self-adhesive label affixed to the dial or a metallic pattern on a flexible circuit board, or with a conductive paint or conductive ink applied directly to the dial. Can be manufactured with printed pads.

The sensor array 502 operably engages with the matrix 500 to detect matrix data. Due to the conductive matrix pattern 501 shown in FIGS. 19 and 21, the sensor array 502 comprises elastic or leaf spring type metal contacts 546, 547, 548, 549, 550 and 551, these contacts. Extends inward in the radial direction from a tubular base sleeve 544 concentrically located on the dial 506. Each of the sensor contacts 546-551 opposes the matrix 500 in a different row, and in the illustrated embodiment the sensor contacts 546, 547, 548, 549, 550 and 551 are the matrix rows 509, 510, 511, 512, respectively. , 513 and 514. Sensor contacts 546 and 549 are mounted in the first circumferential position of the base sleeve 544, sensor contacts 547 and 550 are mounted in the second circumferential position of the base sleeve 544, and this second position is from the position of contacts 546 and 549. It is 120 ° apart, and the sensor contacts 548 and 551 are mounted in the third circumferential position of the base sleeve 544, which is 120 ° away from both the contacts 546 and 549 and the contacts 547 and 550. standing. The uniform angle arrangement of this sensor contact around the matrix provides centering of the matrix and limits frictional resistance. Due to this 120 ° spacing, when the dial 506 is rotationally oriented with respect to the sensor array 502 and each of the contacts 546 and 549 abuts the matrix 500, for example in the column 516, the contacts 547 and 550 Each abuttes Matrix 500 in column 524, and contacts 548 and 551 collide with Matrix 500 in column 532.

When the sensor contact 546, which acts as a ground contact, is aligned with the column 516 as described below, this is the "home" or "zero" position of the dial in the illustrated embodiment. If the pen's injection mechanism is manipulated to release a zero volume drug, the dial will occupy this home position. At this home position, the ground is not electrically connected to any of the other contacts 547-551. This matrix pattern can be applied to display this home position, for example, even if all columns 519, including column 516, are filled with a conductive pattern. Due to such a matrix pattern, the pattern may also be formed so that the sensor contacts 546 do not touch any of the other sensor contacts 547-551 when aligned with the column 516.

The matrix pattern 501 shown in FIG. 20 is designed to complement this contact arrangement. Matrix pattern 501 uses gray code, which encodes a scheme that reduces the risk of errors that make dial position detection undetectable. In this Gray code code scheme, the pattern is constructed in view of the sensor position, and the movement of the dial in both directions and in the same amount of rotation for one column is only one of the sensor contacts 547-551 related to the electrical circuit with the pattern. A switch can be made and the only switch can be monitored by the controller (ie, the only sensor contact changes from unconnected to the pattern to contact with the pattern, and vice versa, and then the rotation of the dial. Moves each sensor contact in the corresponding given column to the column on either side of the given column.) In the illustrated embodiment, of the 24 rotational setting positions of the dial 506 with respect to the sensor sleeve 544. Each yields the only information setting recognized by sensor contacts 546-551.

It is possible to use column positioning of the sensor contacts different from the three 120 ° separated settings described above, for example all of the sensor contacts 546-551 are one, as long as appropriate modifications are made to the conductive matrix pattern. It will be appreciated that it can be aligned with the matrix column.

In order to maintain proper alignment of the matrix pattern 501 and the sensor contacts, the sensor array 502 and the rotating matrix 500 are rotatable and axially immobile with each other. Due to the sensor array / rotation matrix shown in FIG. 19, the sensor array 502 is keyed and dialed, eg, against the housing of the pen base 444, and thereby against the dial 506 during dose setting. It is free to move, but cannot rotate. A connection (not shown) between the dial 506 and the sensor array 502 can be used to cause a transition with the dial in the sensor array.

The sensor contacts 546-551 of the array 502 are wired to controller 426, respectively, as shown abstractly on line 432, the sensor input is used by controller 426, and an automatic match table is used to pull the matrix position. This is similar to the method described above in connection with the automatic container recognizer. For example, during use when a ground signal is being sent to the sensor contact 546, this sensor contact is in contact and the matrix pattern 501 is grounded at all rotary dial positions except when the sensor contact 546 is aligned with the matrix column 516. To do. When the conductive matrix pattern 501 is grounded in this way, each of the sensor contacts 547-551 in contact with the conductive matrix pattern 501 is also grounded. The setting of the grounded / ungrounded signal received by the controller 426 via line 432 for all sensor contacts is used to detect the rotational position of the matrix 500 and the rotational position of the dial 506 with respect to the sensor array 502. When the sensor contacts 546 are aligned with the matrix column 516, none of the contacts are grounded and that information is also recognized by the controller 426 as displaying a special one of the 24 rotation positions of the dial 506.

The data in the Matrix 500 with the area of conductive material contributes to the completion of the electrical circuit with the electrical contacts of the sensor due to such data. In alternative embodiments, different matrix data forms may be used in response to modifications to the sensor array. For example, if an optical or electromagnetic sensor element is employed within the sensor array 502, its matrix data can be marking or magnet as appropriate.

The matrix / sensor array shown in FIG. 19 is merely one suitable form and can be configured separately within the scope of the present invention. For example, the placement of the sensor array and matrix can be reversed, in which the sensor array 502 wired to the controller 426 is mounted on the dial 506 and on the inner peripheral surface of the concentric sleeve 544. It is configured to engage with.

Further, and as further described in connection with the embodiment of FIG. 23-30, both the matrix and the sensor array can be placed on reusable pen-based components, these configurations. The element rotates at different times during dose setting and injection use of the injection pen 440. Slider assemblies are placed between the controller 426 and such rotation sensor arrays to facilitate signal transmission. As outlined in FIG. 22, the array of sensor contacts 546'-551'is shown partially mounted concentrically on the second pen component 559, which is shown partially. It is mounted on the first pen component 558. The pen component 558 is completely surrounded by six conductive metal bands 560-565, which fit into the radial outer peripheral corridor. Bands 560-565 are in contact with the outer ends of sensor contacts 546'-551', respectively, and these contacts extend through the radial thickness of component 558. The sensor contacts 546'-551' are configured and arranged in the same manner as the sensor contacts of the embodiment in Figure 19-21 and come into contact with a rotation matrix (not shown) similar to the matrix 500, which is a pen component. Surrounds 559. The slider assembly 570 has six elastic electrical contacts 571-576 with free ends that slide along bands 560-565 as the pen component 558 rotates, and such sliding contacts are the slider assembly. It provides an electrical connection between the sensor 546'-551' and the slider contacts 571-576 at any rotational position of the pen component 558 relative to the 570.

If the internal structure of the injection pen is configured so that the pen components 558 and 559 do not move or move axially during operation, the slider assembly 570 is flexible to hold the microprocessor fixed to the injection pen housing. Mounted on static pen-based components such as sex circuit boards, it can serve as a controller 426. Slider contacts 571-576 are connected to contacts on the circuit board that are routed to the controller microprocessor. For this type of slider assembly mounting, besides the limited axial play that may be required for the structural parts of the injection pen, the slider assembly 570 is axially and rotationally within the pen base 444. It is fixed. If the pen components 558 and 559 transition together during pen operation, slider contacts 571-576 are wire-connected to controller 426 and slider assembly 570 is keyed to, for example, the pen outer housing. It is also connected to the pen component 558 and is configured to move with the array of sensor contacts 546'-551' but not rotate together.

The injection pen controller 426, which processes the signals from the automatic container recognizer 422 and the dose checker 424 to determine the display information, is configured within the pen base 444 by any suitable method known in the art. Can be worn. In one embodiment of the invention, the controller 426 comprises a battery-powered programmable microcontroller mounted on a flexible main printed wiring board, because the distribution frame is generally U-shaped and flexible. Provides a hollow space that fits inside the pen base housing and extends the internal structural components of the pen base 444. The flexible distribution frame is connected to the housing with placement pins and adhesives. In alternative embodiments, application specific integrated circuits or ASICs can be replaced for microprocessors.

The injection pen display 428 is operably combined with the microcontroller 426 and is visible through the transparent housing window of the pen base 444. A display 428, such as a liquid crystal display, displays useful information for the operation of the injection pen so that the user can see it. For example, as best shown in FIG. 13, the display 428 is activated by the microcontroller 426 and displays information about the drug in the retention cartridge recognized by the automatic cartridge recognizer 422 at the 580, 582. As will be further described later, when the injection mechanism of the pen 440 is operated, the injection pen is ready for management. The remaining amount of the battery for spraying the therapeutic drug amount and supplying power to the electronic components of the injection pen 440 with the 584. Display the amount. The information presented at 580 relates further to the concentration of the drug as described above, but other types of information may also be provided. The dose unit to be controlled is shown in Figure 13 printed on 586 above the underside of the housing window, but may be part of a display controlled by microcontroller 426. ..

The structure of the therapeutic dose display device within the injection pen 440 will be further understood in light of the following description of its operation. When the cartridge assembly 442 is attached to the pen base 444, the controller 426 remains ready to disappear all display elements and not display any information to the user. In this ready state, controller 426 processes the signal received from the sensor contacts of automatic cartridge confirmer 422 to sample, for example, the concentration of drug held in the cartridge assembly by the confirmer band. Confirm that. In this ready state, the controller 426 also processes the information received from the sensor contacts of the dose confirmer 424 to locate the matrix 500 with respect to the sensor array 502.

The controller 426 advances from this ready state to the working state, and the display 428 is thereby activated when the controller 426 detects further user movement on the pen 440. For example, such motion detection is typically the recognition that the matrix 500 is moved relative to the sensor array 502 during user manipulation of the dose setting mechanism. Another action that can be detected is an on / off button action (not shown), which button can be located on the pen base 444 or part of the knob 508 of the injection mechanism.

When advanced to a working state, the controller 426 displays the concentration confirmed by the automatic cartridge recognizer 422 at 580. If controller 426 fails to recognize any of the density information, an error message such as "-" or a completely blank message will be displayed on the 580 instead of some density value. Recognition failure is due to the cartridge assembly being completely disengaged from the pen base 444 or not properly seated, or the cartridge confirmer being damaged or missing from the assembly, or the automatic cartridge recognizer. It results from internal destruction of the circuit. If the concentration information is not automatically recognized, the concentration used by controller 426 can be a user-formed value. For example, the setting button 588 shown in Figure 13 is wired to controller 426 and selected for standard concentration values such as 6, 12 and 24 mgs for hGH pre-programmed in controller 426. And it can be pushed down so that it is displayed at 580.

When controller 426 is in operation, knob 508 is turned by the user to set the dose to be released, so controller 426 continuously receives inputs simultaneously from the sensor contacts of dose confirmer 424. Check the position of the matrix 500 with respect to the sensor array 502. Controller 426 processes the input to determine where dial 506 should go, and thus in the illustrated embodiment the matrix 500 is from a "zero" dial position where the drug is not released if the pen injection mechanism is manipulated. It is turned. For example, if sensor 546 meshes with column 516 at this "zero" dial rotation position, controller 426 determines when sensor 546 meshes with each of columns 517-539 to create which dial rotation percentage. recognize. Typically, after injection of the setting dose automatically or manually, the dial is returned to the original "zero" position for the next use. However, controller 426 may be designed to determine the dose setting based on the starting point of the dial.

Controller 426 senses the rotational position of the dose setting dial via the matrix / sensor array interface, which is either dialed or dialed up to increase the set dose, or set dose. Is dialed down to reduce. In addition, controller 426 is programmed to calculate and report one or more complete rotations of the dial during dose setting. By recognizing the position of the matrix with respect to the sensor array in the direction in which the dial is about to be turned during dose setting, the controller 426 will be moved in that direction with respect to the "zero" dial position during exercise. recognize. In particular, if the "zero" dial rotation position is where the sensor 546 meshes with the column 516, the controller 426 has increased the set dose if the sensor 546 reaches column 516 immediately after it was in column 539. And if the sensor 546 reaches column 516 immediately after it is in column 517, it recognizes that the set dose is decreasing.

For example, the dial is initially placed in the "zero" dial rotation position, the "zero" dial rotation position is reached for the first time and the dial-up continues, and then the "zero" dial rotation position is reached a second time. And while the dial-up continues, if the controller 426 senses through the matrix / sensor array, for example, that the user has stopped dial rotation when the dial reaches the sixth position from the "zero" position. , Controller 426 recognizes that 54 unit volume doses for injection (ie, 24 positions in the illustrated embodiment or 2 full rotations of each unit volume plus 6 additional positions) have been set. If the dose is initially set by the user to an amount that is too large and then the user reduces the dose setting prior to injection, the dial down through the "zero" rotation position is one or more full rotation of the dial. Will be reported by controller 426.

The dose confirmed by controller 426 with the dose confirmer 424 is used to spray the actual therapeutic dose to be injected. In particular, controller 426 essentially increases the concentration displayed at 580 by the volume set by the rotation of dial 506 and produces an injectable amount of therapeutic agent to be sprayed at 582. The increase steps described above are usually performed by controller 426, which refers to an automatic collation table with built-in data based on therapeutic concentration and the number of dial "clicks" selected. The 582 spray sprays the injectable amount throughout the dose setting process. For example, if each "click" corresponds to a unit dose of 0.024 ml and the cartridge concentration is 6 mg as described above, each dialing of the 15 degree dial 506, or 1 click, is illustrated on the display 582. Milligram labels are increased by 0.05, and similarly, when the cartridge concentration is 24 mg, each one click on dial 506 is incremented by 0.20 on the indicated milligram label on the display 582. In this way, the therapeutic amount that is constantly sprayed at 582 is a medically significant amount that can actually be injected with the injection pen 440. User calculations based on the concentration of hGH loaded in the cartridge assembly 442 are no longer necessary to understand how much hGH is about to be injected.

In addition, the amount of display at 582 is made throughout the injection (ie, the amount of display to be injected), which is injecting the pen component on which the matrix and sensor array are placed. This is done when they are designed to rotate favorably with each other.

After the injection pen 440 is used to inject the set dose as by pushing the knob 508 axially and moving the dial 506 into the pen base 444, the controller 426 automatically returns to the off state and is inactive. All of the display elements of the display 428 are turned off following the specified period of time. If the injection is not made immediately after the dose setting, the display remains on until the injection is made, after which the pen turns off after the inactivity period described above.

As further described below, the doseable indicator can be used in a release device that lacks the automatic cartridge recognition system described herein, each of which has the only concentration. The different drugs that have are released. In such devices, the display at 582 can be a numerical value or other piece of information that indicates the actual dose available.

In FIG. 23, there is shown a typical embodiment of a drug syringe device with an assembly for selectively turning the drive sleeve of the present invention. This device, generally labeled at 620, is shown in the form of a reusable injection pen, but other forms of portable syringes are also within the scope of the invention.

The injection pen 620 is equipped with a reusable pen generally labeled 622 and is fitted with a cartridge assembly widely labeled 624 and further referenced in FIG. In FIG. 23, the cartridge assembly is shown to be housed within a substantially removable cap assembly 626. Further, as shown in FIG. 27, the cap assembly 626 includes a metal tip clip 627 swaged relative to the metal cap shell 629, and a plastic tubular cap insert 633, which insert is the shell. It is fixed inside the 629 and has a module for mounting on the cartridge holder. Insert 633 is not shown in FIG. 24 for ease of illustration. The pen base 622 houses the dose setting and injection assembly, which when manipulated the dosage is selected and then released from the cartridge assembly 624 through the pen needle assembly 628, which is further shown in FIG. Referenced.

Further in connection with FIGS. 24-27, the cartridge assembly 624 is a common type known in the art and is equipped with a reusable cartridge holder or retainer 630. The base end 631 of the holder 630 can be connected to the tip of the pen base 622 in a suitable manner such as via an internal screw. The holder 630 has a chamber compartment in which a disposable cartridge 632 is packed for use.

The cartridge 632 is of the standard type as described above and includes a drug-filled glass housing 634, a piston 638, a bulkhead 644 and a cap 646. The leg 640, which is rotatably mounted on the tip of a drive screw 780 extendable from the pen base 622 by a snap fit, distributes the moving force onto the piston 638. An opening or window 642 on the opposite side of the cartridge holder 630 allows visual observation of the amount of drug left in the cartridge being held. An external thread 650 on the tip of the cartridge holder 630 allows mounting of the hub portion 652 of the pen needle assembly 628. When the assembly 628 is mounted as shown in FIG. 24, the base end 654 of the needle cannula 656 held within the hub portion 652 pierces the septum 644 and the drug is injected with the pen 620. It is ejected from the cartridge 632 through the needle cannula 656 inside. Although the needle assembly is shown to have only one injection needle, the needle assembly used in the pen 620 may be of any pen type known in the industry, including a microneedle array1 Includes or more assemblies with shortened needles, but without limitation.

In the illustrated embodiment, the pen needle assembly 628 further comprises a needle cover 658, which cover interferes with the hub portion 652. When the pen 620 is not in use, the cap assembly 626 fits onto the tip of the cartridge assembly 624 and is removable snap-fit to the cartridge holder 630 using meshing detents and dents. The cam structures on the cartridge holder 630 function to properly rotatably align the cap assembly 626 onto the cartridge holder 630 when connected to each other, and further push the cap assembly 626 axially away from the cartridge holder 630. , Remove the snap fit between the two, and the cap assembly is turned against the cartridge holder while it is removed from them. The decorative trim ring 662 is fixedly connected around the base end 631 of the cartridge holder 630 for aesthetic purposes, such as through adhesion.

In the pen 620, after the contents of the given cartridge 632 have been exhausted by the use of an injection device, the user can separate the holder 630 from the pen base 622, remove the used cartridge 632 and dispose of it, and then dispose of the refill. Insert the cartridge into a reusable holder, which reconnects to the pen base 622 for use. Window 642 helps hold the cartridge while removing it from holder 630.

In alternative embodiments not shown, and rather than the separable cartridges and holders shown, the cartridge assembly may be configured separately from those known in the art and described above. For example, the cartridge assembly 624 can be assembled from multiple components during manufacturing into a disposable unit that is treated as the only piece by the user.

The cartridge holder 630 is detachably attached to the pen base 622 by screwing its internal threaded base end onto the external thread 664 of the tubular front housing 666. The front housing 666 is snap-fitted to the tip of the housing main body, commonly represented by the 670, via an angled detent 667. The angled keys 668 of the front housing 666 fit into the keyway 671 of the housing main body 670 to prevent relative rotation between them.

Although the housing main body 670 is integrally molded, it can also be used when assembling multiple parts. The housing end cap 676 snap-fits to the base end of the main body 670 via a protruding collar 677 and is axially secured to each other.

It is the tubular sleeve dial 680 that extends axially and extends axially through the central opening of the end cap 676. A set of three angled notches or keyways 681 along the base edge of the dial 680, and a set of three snap slot recesses 682 in the dial, respectively, of the base 690 of the dial assembly. It houses a key 692 and a latch rib 693 and provides a rigid and permanent assembly of the dial knob base 690 to the dial 680 with a single snap fit. This dose knob assembly features a cover 695 that is glued or secured to the base 690 by the key 696 of the cover 695 that fits into the notch 694 of the base 690. In one embodiment, the dose knob base 690 is plastic and the cover 695 is a die-cast component. A grip feature 697 formed on the outer circumference of cover 695 enhances the grip of the dial knob assembly during rotation or dialing for dose setting. Inside it, the dial knob cover 695 is provided with a centering protrusion or an alternative ring-shaped seat, which serves to center the tip of the priming spring 699.

In the vicinity of its tip, the dial 680 comprises a radially protruding key 683, which is inserted into a longitudinally extending keyway (not shown) formed on the inner surface of the barrel 700. This key stop provides a consistent rotational movement between the dial 680 and the barrel 700 and allows the dial 680 to move axially with respect to the barrel 700. A double spiral screw 685 protruding radially inward from the tubular inner surface of the dial 680 accompanies the spiral groove 712 formed on the outer surface of the drive sleeve 710 of the drive sleeve assembly commonly labeled 708. Or screw. By making one of the double threads 685 and the corresponding groove 712 thinner than the other threads and grooves, a one-way assembly of the dial to the drive sleeve is achieved. Different threaded structures can be used in alternative embodiments, including single thread and groove connections. The arrowhead 686 formed on the dial 680 indicates the direction in which the dial 680 is inserted onto the drive sleeve 710 for ease of assembly. The zero stop 713 is the tip of the groove 712 abutted by the dial screw 685, preventing the dial 680 from being dialed below the zero setting of the pen. The maximum dose stop formed as a collar 720 with a pair of axially extending latch prongs 721 snap-fitting into the recess 714 in the drive sleeve 710 meshes the dial screw 68 with the base end of the groove 712. It fits into the base end of the drive sleeve 710 to prevent the dial 680 from being dialed beyond the maximum setting.

The barrel 700 is provided with an annular rib 702 at its base end, the rib extending continuously around the outer peripheral edge of the barrel. The tip surface of the barrel rib 702 features a series of axially extending unidirectional teeth 703 for engagement with the annular dial clicker 725. The base end face of the dial clicker 725 is equipped with a ring of axially extending unidirectional teeth 726 that accompanies the barrel teeth 703. The tip surface of the dial clicker 725 comprises a ring of axially extending unidirectional teeth 732 on the proximal end surface of the annular dial clutch 730 and accompanying axially extending unidirectional teeth 728.

A set of four keys 733 protrudes radially outward from the outer periphery of the clutch 730 and fits into an axially extending keyway 673 within the housing main body 670 to prevent the clutch 730 from rotating with respect to the housing. .. The spiral compression spring 735 has one end that abuts the bulkhead 672 formed within the housing main body 679 and a multi-end seated on the tip surface of the dial clutch 730, which springs the clutch 730 from the clicker 725. The barrel rib 702 is urged to provide an audible click during the dose dial and to provide rotational positioning during the dial. In particular, when the dial 680 is dialed up to move axially to the proximal end, the clicker tooth 728 engages with the tooth 703 of the rotating barrel 700 to cause the clicker 725 to rotate and the clicker tooth 728 becomes the clutch tooth 732. Slide over. When the dial 680 is dialed down, the clicker tooth 728 is fixed in the rotational direction. The clicker 725 is fixed in the rotational direction by meshing with the tooth 732 of the clutch 730, so that the barrel tooth 703 exceeds the clicker tooth 726. Slide. As is known within the industry, this tooth sliding motion results in dial clicks.

The barrel spring 735 urges the barrel 700 to the proximal end side, and the axially extending outer spline 704 is formed in the housing main body 670 at the tip of the barrel, except during the injection operation of the pen 620 as described below. Does not mesh with the complementary inner spline of the bulkhead 718. The number of splines of the bulkhead 718 is 24, and they are arranged around the drive sleeve at equal intervals in the circumferential direction. The barrel 700 is held retracted towards the proximal end, which occurs when the proximal side of the barrel lip 705 abuts against the drive sleeve flange 716 and the drive sleeve is retracted towards the proximal end, which retracts into the ring. Until the 760 fully meshes the clicker 754 with the spline of the housing bulkhead 718. The spline 704 is integrally formed as four bow segments on the inner lip 705 of the barrel, and the spacing between the segments provides clearance for the lug 655. The base end surface of the lip 705 is arranged on the drive sleeve 710 and functions as a contact surface for injection force, and at the same time functions as a support surface for the relative rotational movement of the drive sleeve 710 and the barrel 700.

When the barrel 700 is shifted to the tip side to compress the barrel spring 735 during injection, the barrel spline 704 meshes with the inner spline of the bulkhead 718 to prevent the barrel 700 from rotating with respect to the housing 670. In another embodiment, blocking the relative rotation of the barrel 700 with respect to the housing 670 can be achieved by unidirectional tooth interference.

The tip region of the drive sleeve 710 is shown to be slightly engraved for improved manufacturability, but is generally tubular and has a circumferential groove 748, a recess 750 on the opposite side of the diameter and a concave side on the opposite side of the diameter. It is equipped with a longitudinal slit 746. The injection clicker 754 is non-rotatably secured to the drive sleeve 710 by four 90 ° distant lugs 655 integrally formed with the drive sleeve, the lugs being the four corresponding recesses in the base end face of the clicker 754. It fits within 647. The clicker 754 is urged toward the proximal end by a clutch spring 758. The retainer ring 760 fits into the groove 748 and prevents disassembly from the clicker drive sleeve. When the drive sleeve 710 is urged toward the proximal end by the action of the barrel spring 735, the lug 655 engages the bulkhead 718 and prevents the drive sleeve 710 from rotating. If the urging force of the barrel spring 735 prevails and the drive sleeve is shifted to the tip during injection, the lug 655 is shifted away from the bulkhead 718, allowing the lug 655 to disengage from the bulkhead 718 spline. This allows the drive sleeve 710 to rotate. The clicker 654 allows an axial shift with respect to the drive sleeve and the clicker teeth 656 allow the bulkhead 718 to slide onto the tilted end face of the spline, which is an audible click display of operation with the drive sleeve 710 turned. It is done when creating and providing rotational positioning during injection. The tip of the clutch spring 758 abuts against the base end surface of the injection clutch 762, which is rendered non-rotatable to the drive sleeve 700 by the key 764, which slides into slot 746. The clutch 762 is further snap-fitted into the recess 750 to provide limited axial play on the drive sleeve 710 to allow drive sleeve movement during injection and axial shift of the floating nut 776 during mounting of the cartridge assembly 624. Corresponds to. The tip surface of the clutch 762 is provided with a ring of torque transmission teeth 766.

The clutch tooth 766 selectively accompanies the drive clutch 770 tooth 772, which is axially held within the injection nut 776. The internal key 774 of the clutch 770 slides in two longitudinal keyways or slots within the threaded drive screw 780 to rotate the drive screw with the clutch. The keyways or slots of the drive screw are formed in the screw along its length by corner or right triangle cuts, these cuts being approximately on the opposite side of the screw. The lead edges of the first corner cut are radially aligned in the thread and similarly diametrically aligned with the lead edges of the second corner cut, which parallels the unaligned or trial edges of the first and second corner cuts. become. The drive screw 780, which extends through the drive sleeve 710 in the axial hole, is screwed into the internally threaded hole in the injection nut 776. The nut 776 is non-rotatable but axially movable in the housing 670 via an angled key 777, and this nut slides in an axially aligned recess 674 in the housing main body 770. When the drive screw 780 is rotated by the forced rotation of the drive clutch 770, the drive screw is screwed through the nut 776 and thus advances toward the tip. The priming spring 699 is press-fitted onto the base end of the drive screw 780. When the screw 780 is reverse driven during cartridge replacement and reset during mounting of the replacement cartridge filling cartridge assembly on the pen base 622, the spring 699 is compressed upon contact with the dial cover 695 and driven in the direction of the cartridge piston 638. Bounce the screw. The injection nut 776 is urged to the tip by an injection spring 784, which acts between the housing bulkhead and the proximal face of the nut 776, and this urging force is applied to the tip of the cartridge 632 during mounting of the cartridge assembly 624. Is defeated by the engagement of.

In the illustrated embodiment, an electronic device is used for dose determination and display, the dose being set and the remaining amount to be injected during the next use of the pen 620. Thus, in the illustrated embodiment, the dial 680 does not need to be supplied with any number or marking, which gives the user a visible indication of how much medicine the pen is operated to inject at the time of use. It is provided and this dial acts as an extension of the grippable knob. The electronics include a conductive matrix pattern 800 around the plastic sleeve 802, which is secured to the drive sleeve 710 in a manner such as glue, snap fit or press fit. An axially extending key of the sleeve 802 fits into the opening in the annular flange 716 of the drive sleeve 710 to prevent relative rotation, allowing proper positioning of the matrix 800 with respect to the drive sleeve 710. The flange 716 also provides a support surface for relative rotation between the drive sleeve 710 and the barrel 700, which receives the tip axial load of the injection and also the retractable proximal side axial load by the spring 735. The matrix-incorporated sleeve 802 forms a drive sleeve assembly 708 with the drive sleeve 710, which rotates and transitions as a single unit during operation.

The matrix sleeve 802 is electrically contacted by a pair of contact ends of an insert-molded leaf spring contact assembly, which is generally labeled 805 and 806 and is further shown in FIG. ing. The contact assembly 805 features a plastic base 807, which is inserted into the cross section of the T-opening 808 inside the barrel 700. The wedge-shaped perimeter of base 807 prevents over-insertion. Four metal leaf springs 810, 811, 812 and 813 are captured in base 807. The matic contact ends 810a, 811a, 812a and 813a of the leaf spring 810-813 extend through the base of the opening 808 and rub against the matrix sleeve to make electrical contact with the conductive pattern 800. The wire contact ends 810b, 811b, 812b and 813b of the leaf spring 810-813 extend outward with respect to the barrel 700 and accept the contact ring, four of a set of six such grooves on the outside of the barrel 700. It fits in the circumferential groove 706 on the most proximal side.

The contact assembly 806 is configured similar to the contact assembly 805 with a plastic base 814, the plastic base is three metals with matrix contact ends 816a, 817a and 818a, and wire contact ends 816b, 817b and 818b. Holds leaf springs 816, 817 and 818. The plastic base 814 is inserted into a barrel opening (not shown) that is longitudinally and angularly offset from the barrel opening 808. The wire contact ends 816b, 817b and 818b extend outside the barrel 700 and fit within the three most distal circumferential grooves 706 of a set of six such grooves. By arranging contacts 813 and 816 in the same longitudinal position and in the same groove 706, one extra contact is provided for matrix pattern grounding. In the illustrated embodiment, the matrix contact ends 816a, 817a and 818a are offset angularly by 180 degrees from the matrix contact ends 810a, 811a, 812a and 813a, but other spacing may be employed.

Again in Figure 27, surrounding the barrel 700 are six contact rings made of metal wrap or coiled springs 820-825. Rings 820-825 are seated in six axially spaced circumferential grooves 706 within the outer surface of the barrel 700, as well as in grooves 809 and base 814, which are also formed within base 807. Is in electrical contact with the wire contact ends 810b, 811b, 812b, 813b and 816b, 817b and 818b, respectively. Rings 820-825 allow the contacts of the rotational stationary slider assembly 838 to remain in contact with the ring, regardless of the relative rotational position of the ring.

The Matrix 800 is conceptually designed and constructed similar to the Matrix 500, but the Matrix contact ends 810a, 811a, 812a are recognized so that 24 different angular positions of the barrel 700 with respect to the drive assembly 710 are recognized. , 813a, 816a, 817a and 818a are designed to work with the angular positions. One suitable matrix 800 is shown in two dimensions in FIG. The rounded protrusions shown on the matrix in Figure 30 are not part of the effective pattern, but rather they are used to help hold the pattern in the part where it is inserted and molded. .. In addition, the matrix 800 pattern is designed as follows: contact ends 810a, 811a, 812a, 817a and are different from expected changes due to movement from one matrix position to an adjacent matrix position in either direction. A single point error in the contacts for the matrix data that collaborates with the 818a and the ground contact ends 813a and 816a is detected by the controller 867 for error detection of the pen operation at all times during the pen operation. In particular, the Matrix 800 is designed as follows, i.e., during the relative rotational movement of the pen component, which moves the matrix by one position from its current position (eg, 15 ° for the 24-column matrix shown). , One change in the signal that works with the ends of the matrix contacts other than contacts 813a and 816a yields only one of the following: Given, such as (a) a shift to a code that corresponds to an adjacent position, (b) a shift to a code that does not correspond to any of the 24 positions, or (c) a range of 2 to 6 positions away from the current position. It is a shift to the code corresponding to the position outside the specified range. Other ranges, such as 2 to 3 or 4 or 5 positions, or 2 to 8 or more positions, may be adopted instead. In other words, for any of the 24 rotational positions, the code for the matrix data in the range of 2 to 6 positions away from the given position in any direction is at least 2 data points from the given position. different. Therefore, while using the pen, depending on whether the dose is being manually dialed up, the dose is being manually dialed down, or the drug is being injected, the controller may be in a position 6 than previously recognized. Given information indicating movements larger than the rotation position, such movements are considered too large by the pen and therefore an error, within a short period of time set by the manufacturer, such as during a display update. If not, within that period the controller will continue to check the matrix data, the received information will return from the previously recognized position to within the acceptable position, and the controller will display an error message. If the received information returns to the acceptable range within the setting period, the pen controller will recognize that the false indication is out of the ordinary and ignore it as such, without displaying the error message. Or request a pen reset. (c) A shift to a code that corresponds to a position outside the given range, such as a range of 2 to 6 positions away from the current position. Other ranges, such as 2 to 3 or 4 or 5 positions, or 2 to 8 or more positions, may be adopted instead. In other words, for any of the 24 rotational positions, the code for the matrix data in the range of 2 to 6 positions away from the given position in any direction is at least 2 data points from the given position. different. Therefore, while using the pen, depending on whether the dose is being manually dialed up, the dose is being manually dialed down, or the drug is being injected, the controller may be in a position 6 than previously recognized. Given information indicating movements larger than the rotation position, such movements are considered too large by the pen and therefore an error, within a short period of time set by the manufacturer, such as during a display update. If not, within that period the controller will continue to check the matrix data, the received information will return from the previously recognized position to within the acceptable position, and the controller will display an error message. If the received information returns to the acceptable range within the setting period, the pen controller will recognize that the false indication is out of the ordinary and ignore it as such, without displaying the error message. Or request a pen reset. (c) A shift to a code that corresponds to a position outside the given range, such as a range of 2 to 6 positions away from the current position. Other ranges, such as 2 to 3 or 4 or 5 positions, or 2 to 8 or more positions, may be adopted instead. In other words, for any of the 24 rotational positions, the code for the matrix data in the range of 2 to 6 positions away from the given position in any direction is at least 2 data points from the given position. different. Therefore, while using the pen, depending on whether the dose is being manually dialed up, the dose is being manually dialed down, or the drug is being injected, the controller may be in a position 6 than previously recognized. Given information indicating movements larger than the rotation position, such movements are considered too large by the pen and therefore an error, within a short period of time set by the manufacturer, such as during a display update. If not, within that period the controller will continue to check the matrix data and the information received will be previously recognized. Returning from the position to the acceptable position, the controller displays an error message. If the received information returns to the acceptable range within the setting period, the pen controller will recognize that the false indication is out of the ordinary and ignore it as such, without displaying the error message. Or request a pen reset.

Those skilled in the art will recognize that in view of the teachings herein, the controller 867 may provide other methods for determining the validity of the sensed position code based on the previously recognized position code. For example, the Matrix 800 does not have to have a unique pattern for all 24 positions of rotation, only for positions within the effective range, such as 1 to 6 positions on either side of a given position. There may be. The controller compares the sensed position code with the position code within the previous code neighborhood and determines that the non-unique position code around it is sensed. The above approach allows 24 positions acquired through a 5-row matrix of 4-bit signals, which replaces the 6-row matrix 800 of 5-bit signals shown. Reduction to a 5-row matrix is not required, but can be used to reduce the number of parts or instrument length. If a 5-bit signal should be used, it improves the overall reliability of the instrument without increasing the instrument length, as it adds redundancy.

In addition, the Matrix 800 was created, in which the matrix data collaborating on the two matrix contact ends in addition to the contact ends 813a and 816a was directly replaced by the Matrix 800 instead of the only data point as described above. It changes when one column shifts. Such an approach allows the controller 867 to reject all single point errors of such sensor contacts, which replaces only those that make more than one data point change, thereby reliance on the instrument. Improve sex. For such a 2-bit shift, if 24 unique rotation positions were desired, a 7-row matrix pattern would be desired, as opposed to the 6-row pattern shown.

Each of the contact rings 820-825 is directly engaged by one of the six slide contacts 840-845 of the slider assembly, which is generally shown at 838, which is further shown in Figure 8. Has been done. The sliding contacts 840-845 are made of metal in a leaf spring shape and are mounted between a pair of keys 849 that project radially from the chassis on the plastic chassis 847. Both keys 849 are inserted into a pair of circumferential grooves or key grooves 707 within the barrel 700, and these key grooves are flanked by the axial sides of a set of six grooves 706. When the key 849 is fitted into the groove 707, the slider assembly 838 moves axially with the barrel 700, but the barrel 700 is allowed to rotate with respect to the slider assembly 838, and the slide contacts 840-845 are the contact ring for the entire period. Electrically connect to 820-825.

The slider assembly 838 is fixedly connected to the flexible circuit board 865, which allows the matrix pattern sensed by the contacts to be transmitted to the microcontroller via the circuit board 865. The slider assembly 838 is placed on the board via a pair of nubs during manufacturing, which project from the back of the chassis 847 and fit into the notch 851 in the board. The slider assembly chassis 847 fits into the opening 678 of the housing body 670, which acts as a keyway, in which the slider assembly 838 is axially movable but non-rotatable with respect to the housing.

To achieve relative motion detection of the barrel 700 and drive sleeve assembly 708, the matrix 800 on the sleeve 802 provides a selected conductive passage between the six contact rings 820-825. The contact ring 823 is always grounded, and the grounded ring is always grounded via its cooperating matrix contact ends 813a and 816a, thereby grounding the conductive matrix 800, which is in the home rotation position. Except for that home position, none of the other rings 820, 821, 822, 824 and 825 are connected to the matrix pattern 800 via the matrix contact ends that work with them. The matrix pattern 800 selectively shorts across the appropriate ring to form a cord, which is then picked up by slider contacts 840-845 and sent to the microcontroller for recognition.

Although described above as the matrix is grounded, in other embodiments the matrix can be activated without a ground signal, but rather with some voltage that is significantly recognizable by the controller. For example, for controllers where the only choice is logical high and low, a logical high signal of about 3 volts may be used to activate the matrix rather than the ground signal described above.

The slider assembly 838 also features an injection switch, generally labeled 853. The switch 853 is made of metal in the form of a leaf spring and has an elastic contact 855 with an inclined region 857. The barrel 700, and thereby the slider assembly 838, are moved axially a short distance during the first phase of the injection operation, and the tilted area 857 is elastically pushed outward by contact with the housing surface 679. Contact 855 completes the circuit with fixed contact 861 of the injection switch. The elastic contact 855 has a contact end 859, and the fixed contact 861 has a contact end 863, each of which is electrically connected to the circuit board 865 to carry an electrical signal to the microcontroller. During the axial movement of the slider assembly, the portion of the flexible circuit board 865 on which the slider assembly is mounted also moves axially with respect to the rest of the board. Closing the injection switch 853 is recognized by the microcontroller 867 as the start of the pen's injection operation, rather than as the pen dials down or up while preparing for injection.

The circuit board 865 is a two-layer flexible circuit board wrapped around the housing main body 670 and is connected to the main body 670 with positioning pins and adhesives. The flexible circuit board 865 serves as the mounting base for the microcontroller 867, which is programmed to control the pen 620, the battery 869 for driving electronics and the LCD display 871.

The pen 620 electronics allow the detection of relative rotational movement of the drive sleeve assembly 708 within the barrel 700, the barrel and drive sleeve assembly being held in an axial position consistent with the mating. During dose setting, the barrel 700 rotates while the drive sleeve assembly 708 is non-rotatable in the housing, and during dose injection the barrel is non-rotatable in the housing and drive sleeve assembly. Lee rotates.

A clear plastic lens 873 is glued to the housing main body 670 and protects the display 871 and provides an enlarged display display. The pushbutton 875 used to control the pen electronics is pivotally mounted on the lens 873 and is in contact with the switch actuator 874, which activates the snap dome switch electrically connected to the circuit board 865. To do. The microcontroller 867 is programmed to turn on the display for work when button 875 is manually pressed. In one embodiment, button 875 can be used for data stored in memory, setting a clock that works with a microprocessor. Data, such as date, stored in memory that works with the microprocessor, can be adjusted by first pressing button 875 and holding for a setting period such as 3 seconds, pen. And then press the dial knob assembly axially to press the slider assembly 838 and activate the injection switch 853 to increase the modified data. The bezel 877 glued to the housing main body 670 acts as a decorative edge along the lens 873, and the push button 875 is exposed through the window 879 of the outer skin 880 made of metal, and the skin is the housing main body 670. Is glued to.

The foam seal 882 is captured between the underside of the lens 873 and the top surface of the flexible circuit board 865. The seal 882 resists possible fluid on the pen outer surface along the junction of the pushbutton 875 and lens 873 reaching the inner electronics of the pen 620. The frame filler 885, which is provided for ease of pen assembly and fits inside the notch in the housing main body 670, acts as an additional base on which the display 871 is glued, and is an addition for the skin 880. It becomes the adhesive surface of.

Cover portion 887 is glued to the underside of the housing main body 670 and has an inner recess to allow space for electronics. The metal outer skin 880 is adhesively attached to both the housing main body 670 and the cover portion 887 to provide an attractive look to the pen 620.

The structure of the injection pen 620 will be further understood in light of the following operating instructions. When the user needs to inject the dose of the drug herself, the pen 620 is first turned by pressing button 875, and the display 871 is now dated and timed by the pen's internal clock and the pen Display 0 as the amount of drug prepared for release. The pen 620 is turned on by starting to turn the dial knob assembly or instead pressing the dial knob assembly to trigger the injection switch. If the pen is turned on via button 875 or by pressing the dial knob assembly, then the dial knob ace embry is pushed axially to the tip and the injection switch 853 is activated, the date and time. And the final injection volume is sprayed. If the pen 620's memory is adapted for multi-dose memory, plunging each additional tip of the dial knob assembly will spray the date, time and amount of previous injections, and therefore. The user may repeat through previous stored doses, which are 10 or more doses. To escape from dosing memory mode, the user waits for a set time, such as 8 seconds, during which time he / she does not dial or press any button, or presses the dosing knob. By dialing from the 0 position or by pressing and releasing the dose knob long enough to repeat through all multiple dose memories.

The pen 620 is then manipulated to allow the user to select the dosage to be controlled. The following description has assumed that the pen 620 is primed as already suggestions, the priming step flop simply later discharges a small dose to expel some air from the cartridge Includes pen operation. For pens with multiple dose memory, an indication that such dose is a priming dose can be added in the memory, due to the depression and release of mode button 875 immediately after the first release. This is done as long as the microprocessor 867 detects that the injection switch 853 is no longer activated, before the end of the 5-second pre-injection timer. When the user sees the dose in memory, the first dose is an alternative time lapse indicated by a "P" in the display. Instead, the first tag involves the user pressing and releasing Mode Button 875, which is done when the first dose is reached when looking at the dose stored in the dose memory.

For dose selection, the user typically grabs the dial knob assembly cover 695 between the thumb and index finger and begins turning it against the rest of the pen base 622. This rotation causes the corresponding rotation of the dial 680, and at the same time causes the rotation of the barrel 700 by being keyed to the dial. As the dial 680 and dial knob assembly rotate, they move axially towards the proximal end because the dial 680 is screwed onto the drive sleeve 710. When the dial is screwed out, it extends further beyond the pen base housing towards the proximal end, and the dial knob assembly is shifted towards the proximal end and further separated from the housing. The drive sleeve 710 is held in a non-rotatable state in the housing spline by the engagement of the lugs 655. If the user turns beyond the desired dose, the dose knob assembly and dial 680, and thus the barrel 700, are turned in opposite directions, which in turn turns the dial 680 to return the drive sleeve 710. During this dial return, the drive sleeve is held in a non-rotatable state due to rotational resistance due to the lug 655. During the rotation of the barrel 700, which is axially stationary with respect to the drive sleeve, the display 871 displays a continuously changing value of the drug amount, which amount at any given point during rotation. It is the amount that the pen 620 injects when it is operated by thrusting. In particular, the display 871 is controlled by the microprocessor 867, which recognizes the rotational position of the barrel 700 with respect to the drive sleeve 710, which is from the operation of the matrix pattern 802, ring 820-825, slider assembly 838 and circuit board 865. Based on the input of. The user holds the dial rotation when she observes that the display 871 is displaying the desired amount of injectable drug. In this regard, the injection pen 620 is configured as shown in the cross section of FIG. 25, and the cap assembly and cover 658 are conventional during the priming process.

The user is now ready to inject the set dose, and this injection operation is done in two forms. First, in the first form, the pen is mechanically switched from dosing mode to injection mode by shifting the dosing knob towards the proximal end and dialing only a small section to return it 0.080 inches into the pen housing. .. In particular, the user typically applies a thrust force with her thumb onto the side surface of the base of the knob cover 695. This plunge puts an axial load on the dial screw 685, via the drive sleeve screw 712, and advances the drive sleeve assembly 708 into the pen 620 toward the tip and by frictional force the dial 680 against the drive sleeve assembly. Does not rotate. This drive sleeve operation moves the barrel 700 to the tip side or forward, due to the tip surface of the flange 716 in direct contact with the barrel lip 705. The transition to the tip side of the dial 680, drive sleeve 710 and barrel 700 stops when the barrel 700 reaches the position where the spline 704 is with the housing bulkhead spline, at which time the barrel becomes non-rotatable and rotatable to the barrel. The dial that is keyed to is also non-rotatable.

When the pen 620 reaches the state shown in FIG. 26, the second form of injection operation begins and some additional thrusting force applied to the dial knob pushes the dial knob assembly and dial 680 to the tip side. The transition occurs without rotation, which causes the drive sleeve 710 to rotate. When the drive sleeve 710 is turned, the injection clutch 762 is also turned, which turns the injection screw 780, which advances the screw in the cartridge and pushes the drug out of the needle for engagement with the injection nut. As the drive sleeve 710 turns, the injection clicker 754 bounces in and out of the housing spline, causing an injection click. The dial 680 is thrust to the thrust axial position corresponding to the position shown in FIG. 24, at which point the dial screw 685 abuts the zero stop 713 and the rotation of the drive sleeve 708 is stopped. During this second form, if the injection nut 776 floats completely rearward, the injection nut spring 784 completes the injection by moving the nut 776 toward the tip when the dial has been fully thrust.

During both forms of injection operation, the microcontroller 867 continuously receives input from an electronic sensor, which picks up the relative rotational motion of the barrel 700 and drive sleeve assembly 708. Throughout the entire injection process, the display 871 immediately displays the amount to be injected due to electronics limitations, which allows the display to be updated, eg, 8 times per second. Since the injection switch 853 is activated when the barrel is moved to the tip side, the microprocessor uses the input from the switch 853 to identify the dose dial and injection. This switch signal can also be used by the microprocessor to store the time, date and injection volume in memory for later reference.

After the injection pen 620 was used to inject the set dose, the controller 867 automatically returned to the off state and all the display elements of the display 871 were turned off, which continued for a predetermined period of inactivity. Will be done. If the injection is not made immediately after the dose setting, the display remains on until the injection is made, after which the pen turns off after the inactivity described above. The pen uses an automatic reset in the process of fully pushing the dose setting knob assembly and dial 680, so for the next dose setting the pen 620 simply turns the dial knob assembly and dial 680 from their pushed position. Is required and no further operation is required.

The microcontroller 867 can use the input received from the injection switch 853 and an electronic sensor that picks up the relative rotational movement of the barrel and drive sleeve assembly to diagnose whether the injection pen is working properly. For example, the pen can be programmed to display an error, which is that the injection switch 853 is activated while the electronic sensor is displaying that the dose is being dialed up. It's time for the microcontroller to detect that. In addition, the error message can be communicated to the user via the display, the error is if the injection switch 853 is not activated, and the input from the electronic sensor is too manually dialed by the user. It is when the dial display suggests doubtful accuracy, as caused by a fast turn.

A special mechanism for converting the rotation of the drive sleeve into the axial movement of the cartridge piston is disclosed in Figures 23-27, but it is known in the industry that the drive sleeve is screwed directly onto the drive screw. It is interchangeable within the scope of the invention with other less complex mechanisms that have been made.

Although the invention is illustrated and described as having multiple designs, the invention may be modified within the spirit and scope of this disclosure. The present application is therefore intended to cover any modification, use or adaptation of the invention using the holistic principles of the invention. Further, this application is intended to cover anything that departs from the present disclosure as originating from what is known or commonly used within the field to which the invention relates.