Patent Application
20070060894
The present invention pertains to:medication dispensing devices, and, in particular to a portable medication dispensing device such as an injector pen.
Patients suffering from a number of different diseases frequently must inject themselves with medication. To allow a person to conveniently and accurately self-administer medicine, a variety of devices broadly known as injector pens or injection pens have been developed. Generally, these pens are equipped with a cartridge including a piston and containing a multi-dose quantity of liquid medication. A drive member, extending from within a base of the injector pen and operably connected with typically more rearward mechanisms of the pen that control drive member motion, is movable forward to advance the piston in the cartridge in such a manner to dispense the contained medication from an outlet at the opposite cartridge end, typically through a needle that penetrates a stopper at that opposite end. In disposable or prefilled pens, after a pen has been utilized to exhaust the supply of medication within the cartridge, the entire pen is discarded by a user, who then begins using a new replacement pen. In reusable pens, after a pen has been utilized to exhaust the supply of medication within the cartridge, the pen is disassembled to allow replacement of the spent cartridge with a fresh cartridge, and then the pen is reassembled for it subsequent use.
While suitable to deliver useful therapeutics, a variety of available injector pens are not without their shortcomings. One shortcoming of some injector pens is that the plunging force required to advance the cartridge piston during an injection may be too large for some users, such as those with limited hand strength, possibly due to the disease being treated. Another shortcoming of some injector pens is that the drive member motion results in a dose accuracy that may be insufficient for some applications. And, while for a given drive member motion, a smaller diameter conventional cartridge in a pen generally can be used to obtain higher dose accuracy, such a smaller diameter cartridge either limits the amount of medicine contained in the entire cartridge, or requires a longer cartridge length, which may be unacceptable to some pen users.
One known syringe disclosed in U.S. Patent Re. 32,974 utilizes a smaller diameter dose chamber and a larger diameter storage chamber within the syringe housing, each chamber having its associated piston. While the overall syringe design may allow an injection to be performed with lower plunging or glide forces as the syringe teaches the injection needle not be mounted during part of the time the syringe is being manipulated, the syringe operation is potentially confusing and complicated for users familiar with the operations of more conventional injector pen technology.
Thus, it would be desirable to provide an apparatus that overcomes one or more of these and other shortcomings of the prior art.
In one form thereof, the present invention provides a medication dispensing apparatus including a fluid container, first and second plungers, a drive assembly, and an actuator. The fluid container defines a medication-filled reservoir including an injection chamber and a storage chamber in fluid flow communication. The first plunger includes a piston sealing an end of the injection chamber. The first plunger is movable relative to the fluid container while maintaining the seal to alter the volume of the injection chamber. The second plunger is movable relative to the fluid container while maintaining the seal to alter the volume of the storage chamber. The sealed end of the injection chamber has a cross-sectional area that is smaller than a cross-sectional area of the sealed end of the storage chamber. The drive assembly is drivingly connected to the first plunger and the second plunger. The drive assembly is operable during dose setting to shift the first and second plungers relative to the fluid container different distances so as to reduce the volume of the storage chamber while simultaneously increasing the volume of the injection chamber a similar amount. The actuator is movable to shift the first plunger relative to the fluid container to reduce the volume-of the injection chamber to force medicine in the reservoir through an outlet of the fluid container.
One advantage of the present invention is that a medication dispensing apparatus can be provided with a small area injection chamber that permits injections to be performed with a low glide force, which low glide force can allow for a direct injection as opposed to a mechanically assisted injection.
Another advantage of the present invention is that a medication dispensing apparatus can be provided which uses multiple chambers, but which outwardly appears to operate similar to some conventional injector pens.
Another advantage of the present invention is that a medication dispensing apparatus can be provided with high dose accuracy, and which can accurately administer small volume doses, thereby being useful for high potency drugs.
Still another advantage of the present invention is that a medication dispensing apparatus can be provided with an actuator that can be distinct from the dose setting element, which actuator form may be familiar to people who use conventional syringes.
Still another advantage of the present invention is that a medication dispensing apparatus can be provided which is designed to contain a number of different volumes in its chambers, and which chambers can be a variety of shapes thereby allowing a small overall device design that is well shaped for discrete usage.
Yet another advantage of the present invention is that a medication dispensing apparatus can be provided that is manufacturable with any one of a number of gear ratios to allow an appropriate actuator travel for expected injections, such as a gear ratio to achieve a sufficiently large travel of the actuator even for small volume doses.
Yet another advantage of the present invention is that a medication dispensing apparatus can provided with a variety of storage chambers to allow ready mixing of materials or delivery of any one of various therapeutics within the chambers.
The above-mentioned and other advantages and objects of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taking in conjunction with the accompanying drawings, wherein:
Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the present invention, the drawings are not necessarily to scale, and certain features may be exaggerated or omitted in some of the drawings in order to better illustrate and explain the present invention.
Referring now to
Medication injector pen 20 is a disposable or prefilled pen, in that after the quantity of medicine contained therein is exhausted by multiple operations of the pen, the entire pen is discarded rather than being reset and reloaded with a replacement container of medicine. As the pen has a relatively short working life, the pen components are preferably molded from one or more polymeric materials such as plastic when possible for cost effectiveness. Other more robust and/or more durable materials of construction may also be used, especially in reusable pens of the present invention which have a longer expected life.
Injector pen 20 includes an external housing 22 that is shown as having an exterior with different sized lobes, which lobes appear as if formed by interconnected, different diameter cylinders. This housing shape, which relates to cylindrical aspects of the fluid container described below, may be changed in alternate embodiments to other shapes, such as more ergonomic or aesthetic shapes, as well as a more box-like shape. Housing 22 has a distal end to which is removably mounted a needle assembly 24 including a double-ended needle cannula or injection needle 25 having a distal tip 26 at one end and a not-shown proximal point at the other. Although the needle assembly is shown as having a single injection needle, needle assemblies which may be used with the present invention may be of various types known in the art, including, but not limited to assemblies with one or more shortened injection needles including microneedle arrays.
A knurled wheel 30 is rotatably mounted on housing 22 and manually rotatable by the user to set a dose for delivery. The positioning of wheel 30 at the intersection of the housing lobes improves user access to the wheel. Wheel 30 is operably connected to a mechanism within housing 22 that visibly displays through a lens covered window 32 of housing 22 the dose that injector pen 20 has been set to deliver by operation of wheel 30. The pen is designed to be set by increments that are adequately small in resolution for the medication involved, such as ten or five microliters. The pen also may provide an audible click or the like upon each increment during the display increasing or decreasing. The dose display is shown as a two-digit odometer type display 33 using a ones disc and a tens disc such as with the incrementing resolution being ten microliters. Other display types may be employed, such as if five microliters is the dosing increment.
Movably mounted on housing 22 is an actuator 34 used to inject medicine from the pen. Actuator 34 is shown as a plunger separate from dose setting wheel 30 and is arranged on the proximal end of the pen housing to allow it to be operated with the finger or thumb of the hand in which the housing 22 is held during dose injection. In
With additional reference to
Fluid container 35 is made of a medically and mechanically suitable material, such as glass or more preferably a polymer or blend of polymer materials, such as a plastic, to facilitate its manufacture and accuracy in sizing in production. Container 35 includes a first cylindrical, tubular portion 37 and a second cylindrical, tubular portion 39 that are spanned by conduit 40. In the shown embodiment, tubular portions 37 and 39 are parallel to each other as well as arranged laterally of each other. Along their internal piston engaging lengths, tubular portion 37 has a constant inner diameter that is larger than the constant inner diameter of tubular portion 39. These constant inner diameter references relate to the fact that its associated piston maintain its seal, as naturally the tubular portion inner diameters may have slight variations, such as a draft angle if formed from plastic. While portions 37, 39 and conduit 40 are shown integrally constructed, such could be manufactured as separate pieces and then sealingly assembled together. Other cross-sectional shapes and arrangements of the tubular portions may be used in alternate embodiments.
Tubular portion 37 defines a large volume storage chamber portion 42 of the medicine-filled reservoir of fluid container 35. Storage chamber 42 is closed at its proximal end by a plunger piston 44 that is axially slidably and sealably engaged with the interior wall 6f tubular portion 37 to hold the fluid medication. The distal end of chamber 40 is closed by a wall 46 of the container. Wall 46 is shown having an internal surface that is flat like the distal face of piston 44 but which could be sloped up from conduit 40 to promote chamber drainage provided a corresponding modification to the piston distal face were preferably provided.
Tubular portion 39 defines a smaller volume injection chamber portion 50 of the medicine-filled reservoir of fluid container 35. Injection chamber 50 and storage chamber 42 are in flow communication via channel 41. Positioning the channel 41 such that it opens as low as possible into each of the chamber portions minimizes wastage of the contained medication at the end of the life of the pen. Plunger piston 52 closes the proximal end of injection chamber 50 and is axially slidably and sealably engaged with the interior wall of tubular portion 39. The distal, outlet end of injection chamber 50 is sealed by a septum abstractly shown at 54. In an alternate embodiment, the distal end of the tubular portion 39 can have a stepped-down neck portion shaped more similar to the distal end of a standard cartridge to better accommodate standard pen needles. In still further alternate embodiments, the cartridge and septum can be cooperatively designed to minimize waste at the end of the useful life of the cartridge or pen. For example, a polymeric cartridge can be molded with a reduced diameter pen needle mounting collar that is directly adjacent the piston containing tubular portion, rather than the collar being spaced from the tubular portion by the tapered form used in the stepped down neck portion of conventional glass cartridges. Still further and with the tubular portion distal end again having a distal end like the conventionally shaped cartridge, the septum, while allowing for penetration by the needle proximal point can extend within the neck to fill space otherwise occupied by medicine that is wasted at the end of the pen life.
When needle assembly 24 is mounted to housing 22 as shown in
Pen 20 is configured such that pistons 44 and 52 are precisely controlled during dose setting to simultaneously change the volumes of storage chamber 42 and injection chamber 50 in equal and opposite amounts, and during dose injecting to reduce the total volume of the medication reservoir in an amount equal to the dose set to be delivered. This control during injecting is preferably accomplished by reducing the volume of the injection chamber without changing the volume of the storage chamber.
This control utilizes a drive assembly including a gear set disposed between the plungers of which pistons 44 and 52 are parts. In the embodiment shown in
The gears of the drive assembly have diameters and subsequent gear ratios selected to account for the differences in inner diameters of the injection chamber 50 and storage chamber 42 as well as relative rotation to properly affect the direction of motion of the plungers, such that during dose setting the hydraulic pressure of the medication in container 35 remains relatively constant. In this way, medication will not be discharged, nor will air be drawn in, through the needle during dose setting. In one embodiment, during dose setting, piston 52 is drivingly shifted by the drive assembly a distance which is six times as large and in the opposite direction as piston 44 is drivingly shifted by the drive assembly. In such embodiment, the inner diameter of injection chamber 50 is about 0.570 cm (0.225 inch), and the height of the tubular portion 39, which is impacted by its piston height, is large enough for the injection chamber 50 to hold a single dose in amounts up to, for example, 0.6 ml, which would correspond to 60 international units for U100 insulin or 120 international units or more for U200 or even more potent or concentrated insulin solutions. And, the inner diameter of storage chamber 42 is about 1.397 cms (0.550 inch), and the height of the tubular portion 37, which is also impacted by its piston height, is large enough for the storage chamber 42 to initially hold up to, for example, 3.0 mls. which amount allows the pen to be used to deliver multiple doses over its life. Different volume chambers, such as larger or smaller chambers, may be used within the scope of the invention.
The particular gear ratio that moves the injection chamber plunger a greater distance than the storage chamber plunger may be selected by the manufacturer in view of the needs of the expected users of the pen. Ratios other than the six value mentioned above may be used. Ratios smaller than six, for example two or four, can be used if the user is expected to be able to provide a greater injection force. Ratios bigger than six, for example, seven, eight or up to twelve or more, may be used where a larger travel or throw of the actuator is desired for the target value or range to be delivered.
Actuator 34 is operably connected to plunger shaft 67. In the described embodiment, the connection may be a direct linkage that results in actuator 34 moving out from housing 22 an amount equal to the distance that plunger piston 52 moves up in fluid container 35 during dose setting. As the dose set is selectable by a user, the ready to inject position of the actuator 34 relative to the housing 22 is different for different doses, which provides a visible cue for the user. When the actuator 34 is plunged toward the housing 22, plunger shaft 67 and therefore piston 52 are driven distally a corresponding amount to force the set dose through the injection needle 25, which distal movement of the rack 66 via its relation to gear 58, causes the display to simultaneously dial down toward zero while continuously displaying the amount of medication still remaining to be injected. In order to prevent the plunger shaft 73 and its piston from backing up during injection so as to increase the storage chamber volume, plunging of actuator 34 activates a not shown decoupling clutch within the housing 22 which disengages the drive assembly so as to not drivingly shift the plunger shaft 73 and piston 44 proximally, as well as which preferably locks the storage chamber plunger, such as by introducing a pawl into rack 72 or locking a drive gear, to prevent proximal floating of shaft 73 and piston 44. Such a disengagement may involve axially shifting spur gear 60 to disengage it from gear 58, or vice versa.
Although actuator 34 is described as providing a direct actuation of the injection plunger, it is within the scope of the invention for the actuator operation to involve a mechanical advantage, such as if, for example, the actuator travel length is desired to be increased to be more recognizable. Still further the actuator can serve as a trigger that initiates a spring assisted, or possibly fully automatic, advancement of the injection plunger to expel the set dose from the injection chamber.
Because the pistons 44, 52 may translate without rotation during use such as in the shown embodiment, cross-sectional piston shapes and chamber shapes different from the circular one shown and described may be employed in alternate embodiments. These other shapes may be used to create fluid containers that, for example, maximize the use of available space to create optimally sized and shaped devices. For example, a dual chamber fluid container having a circular cross-section in overall shape may be provided, but which container has a cross-sectional crescent shaped injection chamber and associated piston, and a storage chamber and associated piston that cross-sectionally is the remainder of the circle. Still further, one of the pistons may be annular, such as if one chamber surrounds the other chamber.
Still further, while the plunger and drive assembly configuration shown in
The structure of injector pen 20 will further be understood in view of the following brief explanation of its general operation. With injector pen 20 arranged as shown in
After the user has set injector pen 20 to deliver the desired dose, the user merely maneuvers the injector pen such that the tip 26 of injection needle 25 penetrates the injection site, and then manually plunges actuator 34 toward housing 22. Plunging of actuator 34 causes plunger movement that reduces the injection chamber volume while not altering the storage chamber volume, thereby resulting in the medication previously within injection chamber 50 being forced through needle 25 into the injection site. An end of injection click may be provided, such as via the use of a detent or the like, to provide an audible indication to a user of when the injection is complete.
Pen 20 can continue to be used to deliver medicine until not enough medicine remains in the pen to deliver a desired dose, which can be indicated to a user in a variety of ways. For example, the user may be unable to dial up such dose because during dose setting the plunger piston 44 bottoms out at wall 46 at which time the dial would indicate the limited amount still available to deliver. When insufficient medicine remains, pen 20 is to be disposed of, typically after administering the amount remaining with the expectation of delivering the shortfall with the next pen, and replaced with a similar but entirely new pen.
The multiple chamber injector pen of the present invention can be adapted to serve as a reusable injector pen. In such an embodiment, after the quantity of medicine contained in its fluid container is exhausted by multiple operations of the pen, the container will be removed, the plungers will be reset, and a replacement fluid container will be loaded into the pen for subsequent use.
Referring now to
One possible valve for such a design is known as the MicroBarrier valve by Waterfall Company, Inc. of Los Altos Hills. Calif.
In an alternate and not shown embodiment, instead of using a one-way valve to accommodate minor hydraulic pressure variance in the reservoir, the storage chamber piston 44 can be formed to account for such variance. For example, the piston 44 can be formed with a pliable pocket or diaphragm. By having such pocket or diaphragm be able to shift small amounts relative to the sealing body of the piston, pressure changes can be addressed without negatively affecting dose accuracy.
Injection pen 20 is shown as a dual chamber apparatus that delivers a single therapeutic. In alternate embodiments, a three, four or more chamber apparatus can be provided to deliver one of a multiple of, or mixtures of, therapeutics. In such a device, several storage chambers are provided, each capable of housing a different material or therapeutic. The storage chambers are in fluid flow communication with a common injection chamber, which fluid flow connections are preferably provided with one-way valves to ensure no backflow from the injection chamber to the storage chambers. The drive assemblies and plungers are configured such that dose setting can occur separately with respect to each of the storage chambers, but in each case the dosed quantity is introduced into the single injection chamber for subsequent injection via operation of a single actuator.
Referring now to
As shown in
Spur gear 58B intermeshes with an axially fixed spur gear 62′ that when rotated operates a not shown worm gear and the like similar to the embodiment of
Bevel gear 58C intermeshes with an axially fixed bevel gear 60′ during dose setting. When gear 60′ is rotated by gear 58C, a not shown bevel gear rotatably fixed to a not shown worm gear and the like similar to the embodiment of
With reference to
While this invention has been shown and described as having preferred designs the present invention may be modified within the spirit and scope of this disclosure. For example, the apparatus may be a fixed dose pen, such that preparing the pen for delivery involves moving it from a ready to dose position to a predetermined ready to inject position for each actual injection. This application is therefore intended to cover any variations, uses or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US04/14532 | 5/25/2004 | WO | 11/21/2005 |
| Number | Date | Country | |
|---|---|---|---|
| 60474787 | May 2003 | US |
