Coded drug reservoir connection element with bendable locking elements

A locking mechanism is provided for use with a reservoir and a reservoir holder so as to prevent unwanted tampering with the reservoir. The mechanism comprises a main body that is coupled to the reservoir. A first bendable feature is provided on the main body. The first bendable feature snaps from a first position to a second position. In the second position, at least a portion of the bendable feature retains the reservoir within the locking mechanism.

FIELD OF INVENTION

The present patent application is generally directed to reservoirs, particularly reservoirs containing a medicament. More particularly, the present application is generally directed to a locking mechanism for use with a reservoir and a reservoir holder so as to prevent unwanted reservoir tampering. As just one example, such medicament reservoirs may comprise an ampoule, a cartridge, a vial, or a pouch, and may be used with a medical delivery device. Exemplary medical delivery devices include, but are not limited to syringes, pen type injection syringes, pumps, inhalers, or other similar injection or infusing devices that require at least one reservoir containing at least one medicament.

BACKGROUND

Medicament reservoirs such as ampoules, cartridges, or vials are generally known. Such reservoirs are especially used for medicaments that may be self administered by a patient. For example, with respect to insulin, a patient suffering from diabetes may require a certain amount of insulin to either be injected via a pen type injection syringe or infused via a pump. With respect to certain known reusable pen type drug delivery devices, a patient loads a cartridge containing the insulin into a proximal end of a cartridge holder. After the cartridge has been correctly loaded, the user may then be called upon to select a dose of medicament. Multiple doses may be dosed from the cartridge. Where the drug delivery device comprises a reusable device, once the cartridge is empty, the cartridge holder is disconnected from the drug delivery device and the empty cartridge is removed and replaced with a new cartridge. Most suppliers of such cartridges recommend that the user dispose of the empty cartridges properly. Where the drug delivery device comprises a disposable device, once the cartridge is empty, the user is recommended to dispose of the entire device.

Such known self administration systems requiring the removal and reloading of empty cartridges have certain limitations. For example, in certain generally known systems, a user simply loads a new cartridge into the delivery system without the drug delivery device or without the cartridge having any mechanism of preventing removal and subsequent cross use of an incorrect cartridge. Alternatively, certain known drug delivery devices do not present a mechanism for determining if the correct type of medicament within the cartridge should be used with that particular drug delivery system. This potential problem could be exacerbated given that certain elderly patients, such as those suffering from diabetes, may have limited manual dexterity. Identifying an incorrect medicament is quite important, since the administration of a potentially incorrect dose of a medicament such as a short acting insulin in lieu of a long insulin could result in injury or even death.

Some drug delivery devices or systems may use a color coding scheme to assist a user or care giver in selecting the correct cartridge to be used with a drug delivery device. However, such color coding schemes pose challenges to certain users, especially those users suffering from poor eyesight or color blindness: a situation that can be quite prevalent in patients suffering from diabetes.

Another concern that may arise with such disposable cartridges is that these cartridges are manufactured in essentially standard sizes and must comply with certain recognized local and international standards. Consequently, such cartridges are typically supplied in standard sized cartridges (e.g., 3 ml cartridges). Therefore, there may be a variety of cartridges supplied by a number of different suppliers and containing different medicament but they may fit a single drug delivery device. As just one example, a first cartridge containing a first medicament from a first supplier may fit a medical delivery device provided by a second supplier. As such, a user might be able to load and then dispense an incorrect medicament (such as a rapid or basal type of insulin) into a drug delivery device without being aware that the medical delivery device was perhaps neither designed nor intended to be used with such a cartridge.

As such, there is a growing desire from users, health care providers, care givers, regulatory entities, and medical device suppliers to reduce the potential risk of a user loading an incorrect drug type into a drug delivery device. There is also, therefore, a desire to reduce the risk of dispensing an incorrect medicament (or the wrong concentration of the medicament) from such a drug delivery device.

There is, therefore, a general need to physically dedicate a cartridge to its drug type and design an injection device that is non-removably retained in a locking mechanism so as to prevent unwanted cartridge cross use.

There is also a general need to provide a dedicated cartridge that is difficult to tamper with so that the cartridge may not be compromised in that the cartridge can be used with an unauthorized drug or drug delivery device. Because such cartridges may be difficult to tamper with, they may also reduce the risk of counterfeiting: i.e., making it more difficult for counterfeiters to provide unregulated counterfeit medicament carrying products.

SUMMARY

It is an object of the present invention to facilitate the correct application of a drug reservoir to a drug delivery device.

This object is achieved by the locking mechanism according to claim1and the drug delivery system according to claim6, respectively. Embodiments derive from the dependent claims.

In the following the term “distal end” refers to a part of the cartridge assembly or of a body or housing which is intended to be arranged at a portion of a drug delivery device from which a drug is dispensed. The term “proximal end” refers to a part of the cartridge assembly or of the body or housing which is remote from the distal end. The term “distal direction” refers to a movement in the same direction as a movement from the proximal end towards the distal end, not specifying a point of departure nor an end point, so that the movement may go beyond the distal end. The term “proximal direction” refers to a movement in the direction opposite to the distal direction.

In one aspect, a locking mechanism for attaching a reservoir within a reservoir holder comprises a cylindrically shaped main body having an outer diameter and a centrally located aperture. At least one bendable feature is provided on the main body. The bendable feature is movable from a first position, in which at least a portion of the bendable feature extends beyond the outer diameter of the main body, to a second position, the portion moving toward aperture until the bendable feature snaps into the second position. In the second position, at least a portion of the bendable feature is provided to retain the reservoir within the locking mechanism.

According to an exemplary arrangement, a locking mechanism for attaching a reservoir within a reservoir holder comprises a main body coupled to the reservoir. A first bendable feature is provided on the main body. The bendable feature may be moved from a first position to a second position. To move the bendable feature from the first position to the second position, the bendable feature is pressed toward the reservoir. In the second position, at least a portion of the bendable feature retains the reservoir within the locking mechanism.

In another aspect, a drug delivery system comprises a drug delivery device with a dose setting member, a cartridge holder secured to the dose setting member, a cartridge contained within the cartridge holder, and a locking mechanism affixed to the cartridge. The locking mechanism comprises a cylindrically shaped main body having an outer diameter and a centrally located aperture and at least one bendable feature provided on the main body. The bendable feature is movable from a first position, in which at least a portion of the bendable feature extends beyond the outer diameter of the main body, to a second position, the portion moving toward aperture until the bendable feature snaps into the second position. In the second position, at least a portion of the bendable feature is provided to retain the reservoir within the locking mechanism.

In a drug delivery system comprising a drug delivery device a cartridge holder is secured to a dose setting member, which may comprise a dose setting mechanism.

In yet another alternative arrangement, a drug delivery system comprises a drug delivery device comprising a dose setting mechanism. A cartridge holder is secured to the dose setting mechanism. A cartridge is contained within the cartridge holder and a locking mechanism affixes to the cartridge. The locking mechanism may comprise a first bendable feature that snaps from a first position to a second position, the second position comprising at least a portion of said first bendable feature that prevents the return of the bendable feature to the first position.

In an embodiment of the locking mechanism the bendable feature is essentially concave to the reservoir when the reservoir is coupled to the main body and the bendable feature is in the first position.

In a further embodiment of the locking mechanism the bendable feature does not touch the reservoir when the bendable feature is in the first position.

In a further embodiment of the locking mechanism the bendable feature comprises a first section, a second section, and a third section.

In a further embodiment of the locking mechanism the first section and the third section are each affixed to the main body.

In a further embodiment of the locking mechanism the first section, the second section, and the third section are configured to form a generally rounded arc shape that, in said first position, radially extends away from the main body.

In a further embodiment of the locking mechanism the main body comprises a flange that extends along at least a portion of the perimeter of the main body.

In a further embodiment of the locking mechanism the main body is mounted on the reservoir, and the reservoir has a neck part that comprises a pierceable seal across the open distal end of the neck part.

A further embodiment of the locking mechanism comprises a thread configured for receiving a threaded needle hub.

A further embodiment of the locking mechanism is manually pressed from said first position to said second position during an assembly step.

A further embodiment of the locking mechanism further comprises a retention feature.

In a further embodiment of the locking mechanism the retention feature comprises a flange extending from the main body that mates with a groove in the reservoir holder.

A drug delivery system comprises a drug delivery device comprising a dose setting mechanism, a cartridge holder, wherein said cartridge holder is secured to said dose setting mechanism, a cartridge contained within the cartridge holder, and a locking mechanism affixed to the cartridge. The locking mechanism comprises a first bendable feature that snaps from a first position to a second position. The second position comprises at least a portion of the first bendable feature preventing the return of the bendable feature to the first position.

In an embodiment of the drug delivery system the locking mechanism further comprises a main body with an aperture extending through the center of the main body.

In a further embodiment of the drug delivery system the bendable feature is essentially concave to the aperture when the bendable feature is in the first position.

In a further embodiment of the drug delivery system the bendable feature comprises a first section, a second section, and a third section.

In a further embodiment of the drug delivery system the first section and the third section are each affixed to the main body.

In a further embodiment of the drug delivery system the first section, the second section, and the third section are configured to form a generally rounded arc shape that, in the first position, radially extends away from the main body.

In a further embodiment of the drug delivery system the main body comprises a flange that extends along at least a portion of the perimeter of the main body.

In a further embodiment of the drug delivery system the main body comprises a flange, and the locking mechanism further comprises an axially extending wall, which extends from the flange and includes a connector for connecting the locking mechanism to the dose setting member.

In a further embodiment of the drug delivery system an outer surface of the axially extending wall of the main body is provided with an outer thread.

In a further embodiment of the drug delivery system the locking mechanism comprises a non-return feature, the bendable feature moving from the first position past the non-return feature to the second position and being held in the second position by the non-return feature.

In a further embodiment of the drug delivery system the cartridge holder is removably secured to the dose setting mechanism.

In a further embodiment of the drug delivery system the cartridge is removably contained within the cartridge holder.

In a further embodiment of the drug delivery system the drug delivery device comprises a reusable drug delivery device.

In a further embodiment of the drug delivery system the dose setting mechanism comprises a rotating piston rod for expelling a set dose from the cartridge.

The term “drug” or “medicament”, as used herein, preferably means a pharmaceutical formulation containing at least one pharmaceutically active compound,

wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.

or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative.

The scope of the invention is defined by the content of the claims. The invention is not limited to specific embodiments but comprises any combination of elements of different embodiments. Moreover, the invention comprises any combination of claims and any combination of features disclosed by the claims.

These as well as other advantages of various aspects of the present invention will become apparent to those of ordinary skill in the art by reading the following detailed description, with appropriate reference to the accompanying drawings.

DETAILED DESCRIPTION

Referring toFIG. 1, there is shown a drug delivery device100in the form of a pen type syringe. This drug delivery device100comprises a dose setting member102, which may comprise a dose setting mechanism, a cartridge holder104, and a removable cap106. A proximal end105of the cartridge holder104and a distal end103of the dose setting member102are removably secured together. The pen type syringe may comprise a re-usable or a disposable pen type syringe. Where the syringe comprises a re-usable device, the cartridge holder104and the dose setting member102are removably coupled together. In a disposable device, they may be permanently coupled together. InFIG. 1, the dose setting member102comprises a piston rod109, such as a threaded piston rod109that rotates when a dose is injected.

To inject a previously set dose, a double ended needle assembly may be attached to a distal end108of the cartridge holder104. Preferably, the distal end108of the cartridge holder104comprises a thread121(or other suitable connecting mechanism such as a snap lock, snap fit, form fit, or bayonet lock mechanism) so that the needle assembly may be removably attached to the distal end108of the cartridge holder104. When the drug delivery device100is not in use, the removable cap106can be releasably retained over the cartridge holder104.

An inner cartridge cavity111defined by the cartridge holder104is dimensioned and configured to securely receive and retain the cartridge120.FIG. 2illustrates a perspective view of the cartridge120that may be used with the drug delivery device100illustrated inFIG. 1. The cartridge120includes a generally tubular barrel122extending from a distal end130to a proximal end132. The distal end130is defined by an inwardly converging shoulder131.

At the distal end130, the cartridge120includes a smaller diameter neck126and this neck126projects distally from the shoulder131of the barrel122. Preferably, this smaller diameter neck126is provided with a large diameter annular bead (not shown) and this bead extends circumferentially thereabout at the extreme distal end of the neck126. A pierceable seal or septum127is securely mounted across the open distal end defined by the neck126. The seal or septum127may be held in place by a metallic sleeve or ferrule124. This metallic sleeve or ferrule124may be crimped around the circumferential bead at the distal end of the neck126. The diameter of the metallic sleeve or ferrule124is shown as diameter D2136. The medicament125is pre-filled into the cartridge120and is retained within the cartridge120, in part, by the pierceable seal or septum127, the metallic sleeve or ferrule124, and the stopper128. The stopper128may be in sliding fluid-tight engagement with the inner tubular wall of the barrel122. Axially directed forces acting upon the stopper128during dose injection or dose administration urge the medication125from the cartridge120though a double ended needle mounted onto the distal end108of the cartridge holder104and into the injection site. Such axial forces may be provided by the piston rod109.

A portion of the cartridge holder104defining the cartridge cavity111is of substantially uniform diameter represented inFIG. 1by diameter D1134. This diameter D1134is preferably slightly greater than the diameter D2′137of the cartridge120. The interior of the cartridge holder104includes an inwardly-extending annual portion or stop that is dimensioned to prevent the cartridge120from moving within the cartridge holder104. In this manner, when the cartridge120is loaded into the cartridge cavity111of the cartridge holder104and the cartridge holder104is then connected to the dose setting member102, the cartridge120will be securely held within the cartridge cavity111. More particularly, the neck126and the metallic sleeve or ferrule124of the cartridge120are inserted in a distal direction into the open proximal end of the cartridge holder104with the metallic sleeve or ferrule124eventually passing entirely into the cartridge holder104. With the cartridge holder104removably coupled to the dose setting member102, the proximal end132of the cartridge120will typically abut a stop provided by the dose setting member102.

A number of doses of a medicament125may be dispensed from the cartridge120. The cartridge120may contain a type of medicament125that must be administered often, such as one or more times a day. One such medicament is insulin. The stopper128is retained in a first end or proximal end132of the cartridge120and receives an axial force created by the piston rod109of the dose setting mechanism that may be provided in the dose setting member102.

The dose setting member102comprises a dose setter117at the proximal end of the dose setting member102. In one preferred arrangement, the dose setter117is rotated to set a dose. To administer this set dose, the user may attach a needle assembly comprising a double ended needle on the distal end108of the cartridge holder104. In this manner, the needle assembly pierces the seal or septum127of the cartridge120and is therefore in liquid communication with the medicament125. The user pushes on the dose setter117to inject the set dose. The same dose setting and dose administration procedure may be followed until the medicament125in the cartridge120is expended, at which time a new cartridge120may be loaded in the device. To exchange an empty cartridge120, the user is called upon to remove the cartridge holder104from the dose setting member102.

FIG. 3illustrates a first arrangement of a locking mechanism200for use with a cartridge that may be used with a pen type drug delivery device, such as the cartridge120illustrated inFIG. 2. More specifically, the locking mechanism200may comprise a flexible material that can be snapped over the distal end130of the cartridge120such that the locking mechanism200form fits or snaps around the metallic sleeve or ferrule124of the cartridge120. In this manner, and as explained in greater detail below, the locking mechanism200can provide a locking feature to the cartridge120. Alternatively, the locking mechanism200may comprise a non-flexible material so that it does not deform when positioned over the distal end130of the cartridge120.

The locking mechanism200shown inFIG. 3comprises a cylindrically shaped main body202defining a centrally located aperture204. This aperture204extends from a proximal end206to a distal end208of the main body202and, when in use, the aperture204is placed over the ferrule124located at the distal end130of a cartridge120. Preferably, this aperture204has a diameter D3210that is slightly larger than the diameter D2136of the metallic sleeve or ferrule124of the cartridge120. The locking mechanism200further comprises an axially extending wall212that extends from a flange214located near the proximal end206of the main body202. This axially extending wall212extends towards the distal end208of the main body202. The axially extending wall212may vary, and may be as long or longer than the cartridge120when the cartridge120is inserted within the locking mechanism200. In addition, the axially extending wall212may include a connector for connecting the locking mechanism200along with the cartridge120to a dose setting member102(i.e., the locking mechanism200may become part of the cartridge holder104).

Near the distal end208, the locking mechanism200is provided with a pass-through or opening216. In one arrangement, this pass-through or opening216is sized or configured so that, when the locking mechanism200is snapped over the metallic sleeve or ferrule124of the cartridge120, the pass-through or opening216will expose a portion of the metallic sleeve or ferrule124of the cartridge120and will provide access to at least a portion of the pierceable seal or septum127of the cartridge120.

In one arrangement, locking mechanism200is intended for use with a standard double ended needle, wherein this needle comprises a hub having an internal thread. As such, an outer surface218of the axially extending wall212of the main body202is provided with an outer thread220that receives such a hub of the double ended needle. Such an outer thread220could comprise a single or a double start outer thread. In addition, when such double ended needle is mounted onto the locking mechanism200, the piercing distal needle projects through the pass-through or opening216and into the pierceable seal or septum127of the cartridge120. Alternatively, the locking mechanism200may be provided without the outer thread220.

In this preferred arrangement, the locking mechanism200is provided with at least one bendable feature230. Bendable feature230comprises an exterior surface238. In one preferred arrangement, the bendable feature230may comprise a first section232, a second section234, and a third section236. First section232and third section236are each affixed to main body202. These three sections232,234,236of bendable feature230may be configured to form a generally rounded arc shape that, in a first position, radially extends away from the main body202so as to be essentially concave relative to the cartridge120when the cartridge120is inserted into the locking mechanism200. The first position is the initial position of the locking mechanism200during assembly. In the first position, at least a portion of second section234of bendable feature230may extend beyond the outer diameter D3210of the main body202. At least a portion of first section232and third section236may extend beyond the outer diameter D3210of the main body202as well. A bottom view of an exemplary locking mechanism, shown inFIG. 4, illustrates the curvature and extension of three bendable features230in relation to the main body202. In an alternative arrangement, the bendable feature230could comprise a continuous beam rather than a beam comprising a plurality of sections.

The locking mechanism200is intended for use with a cartridge, such as the cartridge120illustrated inFIG. 2. As illustrated inFIG. 5, the locking mechanism200is affixed to a cartridge500. Cartridge500has a neck with a flange against which a rubber membrane is secured by a ferrule524beaded under the flange. The bottom of the cup-shaped cap has an opening through which part of the membrane protrudes.

FIG. 5shows the locking mechanism200with bendable features230in the first position. As can be seen inFIG. 5, in this first position, bendable features230are shaped concave relative to the cartridge500.

Bendable feature230is operable to affix the locking mechanism200to a cartridge500in response to a certain mechanical input, such as during an assembly procedure or a user initiated procedure. During this mechanical input step of locking mechanism200to cartridge500, bendable feature230is moved from the first position to a second or final position. To effect the transition from the first position to the second position, assembly tools (or perhaps a user) may press or push against the exterior surface238of bendable feature230, applying pressure in the direction toward the centrally located aperture204. The bendable feature230is configured such that, when pressed toward the reservoir (cartridge500), the bendable feature230deforms, with the second section234moving toward aperture204until the bendable feature230snaps into an inverted position. This inverted position is the second position, and is shown inFIG. 6.

FIG. 7illustrates the locking mechanism200attached to the distal cartridge portion as shown inFIG. 3, when the bendable feature230is in the second position. More specifically, the locking mechanism200is snapped over the distal end510of the cartridge500such that it fits around the ferrule524of the cartridge500. When the bendable feature230is in the second position, the cartridge500is non-removably retained within locking mechanism200.

FIG. 8illustrates the movement of the bendable feature230from the first position810to the second position820. The bendable feature230moves from a first position810along the path of arrow830, to a second position820. In one embodiment, as bendable feature230moves along the path of arrow830, the bendable feature230moves past non-return feature840of locking mechanism200, and rests in the second position820, with at least part of bendable feature230behind ferrule860. In the second position820, bendable feature230is shown to be bound by inner surface850and the surface of the ferrule860. Non-return feature840may vary in length, and as a consequence, the area of inner surface850may vary. Non-return feature840may, for example, be shorter (or larger) than what is shown inFIG. 8.

One advantage of using the locking mechanism200is that the fit of bendable feature230against ferrule860and inner surface850prevents the locking mechanism200from unwanted removal. That is, bendable feature230prevents unwanted removal of the locking mechanism200from the cartridge when a double ended needle is either attached or removed from the distal end of the locking mechanism.

Those of skill in the art will recognize that alternative geometries of this bendable feature230may also be used. For example, the thickness, depth, or length of any of the first section232, second section234, or third section236may be altered. As another example, the curvature of the bendable feature230may be increased or decreased. A change in any of these features may alter the force required to snap the bendable feature230toward the cartridge. Indentations may be present along the length of bendable feature230. The indentations may weaken the structure, aiding deformation of bendable feature230. More than one bendable feature230around the circumference may be provided. One advantage of having multiple bendable features230is that the cartridge may be retained in a plurality of locations. In addition, a plurality of locking mechanisms200may be provided in various colors so as to provide further differentiation or coding among various cartridges, cartridge holders, or the medicament contained within the cartridges.

An alternative exemplary embodiment is shown inFIG. 9. In this alternative embodiment, the bendable feature930comprises a first section932, a second section934, and a third section936. The first section932and third section936of bendable feature930each have an angled edge940, effectively reducing the material on each of first section932and third section936. Reducing the material of these sections may weaken the sections such that when bendable feature930is in the second position, if the locking mechanism is forcibly removed from the cartridge, bendable feature930will be damaged and will no longer be able to retain the locking mechanism. This provides for a tamper-evident mechanism. Other tamper-evident features may also be envisioned, such as a label that may be affixed to the locking mechanism, that if manipulated, may tear or rip.

Locking mechanism may incorporate an interlocking means to prevent rotation relative to the cartridge holder. As an example, the locking mechanism may comprise protrusions with a triangular section pointed towards the distal end. As another example, rotation may be prevented by friction between the mechanism and the holder. In another alternative, retention features may clip the cartridge to the cartridge holder while still enabling for easy removal. Such retention features may comprise an interference fit, a snap fit, or a bayonet-style feature.

An exemplary retention feature is illustrated in the alternative arrangement shown inFIGS. 10 and 11. In this alternative arrangement, a locking mechanism may comprise a full flange ring. This arrangement is illustrated inFIGS. 10 and 11.FIG. 10shows a locking mechanism700with a full flange ring710. Full flange ring710is continuous along the entire perimeter of locking mechanism700near the proximal end720of locking mechanism700.FIG. 11illustrates locking mechanism700in place within a cartridge holder740that holds a cartridge750. Cartridge holder740may comprise a groove or channel742, as shown. This channel742may correspond with flange ring710, such that flange ring710mates or fits within channel742when locking mechanism is mounted on cartridge750, and resides in the second position. The full flange ring710may increase the strength and stiffness of the locking mechanism700.

The proposed locking mechanism may apply to any drug delivery device, with any type of reservoir or primary pack, e.g. inhaler, pouch. The proposed locking mechanism may also comprise a coding method to the cartridge holder to prevent insertion of a cartridge into the incorrect holder. The locking mechanism may comprise a color that distinguishes the cap to be used for a specific drug.

The proposed locking mechanism results in a number of advantages. For example, the proposed locking mechanism helps to ensure that a delivery device can only be used with a medicament for which the device is intended. The locking mechanism prevents a user from removing the locking mechanism and fastening it to another cartridge. The mechanism is also tamper-evident; if removal is attempted, the locking mechanism may become damaged.

The locking mechanism also results in a low cost mechanism since the interface does not require a large number of parts and can be manufactured in a cost effective manner.

Exemplary embodiments of the present invention have been described. Those skilled in the art will understand, however, that changes and modifications may be made to these arrangements without departing from the true scope and spirit of the present invention, which is defined by the claims.