Patent Application
20100030158
The present invention relates to a medical delivery system comprising a container and a dosing assembly. In particular the present invention relates to medical delivery system wherein one of the container and the dosing assembly comprises a rotatable element adapted to engage the other one of the container and the dosing assembly. Furthermore, the present invention relates to a container and a dosing assembly each of which are suitable for use in the medical delivery system according to the present invention.
Generally, in order to provide superior medication delivery devices which are likely to be well received by particular groups of patients, a greater diversity in drug delivery systems have been launched to the benefit of patients. As the number of commercially available delivery systems increase, numerous different types of medication holding cartridges or containers are distributed. Most of these types of containers differ in various aspects.
Each medicament container may be filled with a particular type of medicament selected from a large variety of different medicaments, but also different kinds of the same class of medicament (e.g. rapid or long acting insulin) and different concentrations of each particular medicament may be accommodated in the containers.
Moreover, different container volumes may be introduced in order to customize each container, and, thus, the delivery system to the needs of particular users. Variation of container volume may be provided by changing the length or diameter of the container. These modifications usually imply corresponding modifications of the dosing assembly of a medication delivery system, so as to provide a particular stroke of a driving element for expelling the medicament from the container or to provide optimal dosing precision. Further discrimination between different medicament containers may be occasioned by the design requirements for each particular delivery system, such as required sliding friction of the piston accommodated in the container.
In order to discriminate between a larger variety of available containers, numerous container coding systems have been developed which primarily relies on the electronic reading and recognition of specific containers in order to allow delivery of a specific type of a medicament by a dedicated delivery device. The following mechanical coding systems are known in the art:
U.S. Pat. No. 5,611,783 relates to a pen shaped syringe comprising a distal part which may comprise an ampoule and a proximal part containing a dose setting and drive mechanism. The proximal and distal parts have interlocking bayonet coupling means. Protrusions may be provided to form a pattern ensuring that a certain distal part may only be used in connection with a certain proximal part.
WO 03/017915 A1 discloses a cartridge having a distal end provided with a mechanical coding. The mechanical coding has the form of a circular protrusion where the circular outer diameter is dedicated a specific concentration of insulin contained in the cartridge.
U.S. Pat. No. 5,693,027 discloses a plastic top for adapting a standard cartridge to a chosen syringe. The plastic top may be provided with means for keyed engagement with corresponding means in a syringe to keep it unrotable when mounted with a cartridge in the syringe. In some types of syringes such keyed engagement between cartridge and syringe is further used to ensure that only a certain type of cartridge is used.
U.S. Pat. No. 6,648,859 B2 discloses a drug cartridge assembly for use with a reuseable pen body assembly of a medication delivery pen. In order to eliminate cross-use the pen body assembly and the drug cartridge are keyed i.e. they may be threadedly engaged by corresponding threads and grooves, bayonet threads, and grooves, snap fits or a pair of lugs that mate in reverse Luer-Lock manner. The mating members are selected so as to prevent cross-use with other assemblies, e.g., the pitch of the threads may be angled so as to mate only with one another and not with other assemblies.
Yet another prior art system is described in DE 201 10 690.
It is an object of a preferred embodiment of the present invention to provide an alternative to the known systems. Furthermore, it is an object of a preferred embodiment of the present invention to provide a medication delivery system with a large number of possible coding geometries.
Furthermore, it is an object of a preferred embodiment of the present invention to provide a coding system wherein the user experiences substantially the same operational fastening movement when the container and dosing assembly of a predetermined medical delivery system are coupled/uncoupled to each other regardless of the specific choice among sets of compatible container/dosing assemblies. Additionally, it is an object of a preferred embodiment of the present invention to provide a system having a large number of differently coded containers/dosing assemblies while simultaneously obtaining a rugged system where the possibility of mechanical failure is minimized
Furthermore, it is an object of a preferred embodiment of the present invention to provide an intuitive fastening mechanism for fastening the container to the dosing assembly.
In a FIRST aspect the present invention relates to a medical delivery system comprising:
By varying the rotational position of the rotatable element in different medical delivery systems according to the present invention, it may be ensured that a container of a first medical delivery system is coded such that it cannot be fastened to a dosing assembly of a second medical delivery system. Analogously, it may be ensured that the container of the second medical delivery system is coded such that it cannot be fastened to the dosing assembly of the first medical delivery system. Accordingly, the medical system according to the present invention improves user safety as only predetermined containers may be attached to a specific dosing assembly. Thus, the dosing assembly may be designated to be used with a predetermined kind and/or concentration of a medicament and containers accommodating other concentrations or types of medicaments cannot be attached to the dosing assembly.
The system according to the present invention provides the advantage that the devices may be coded by varying the rotational position of the rotatable element. This is advantageous from a manufacturing point of view, as the same tools used for manufacturing a container, a dosing assembly and a rotatable element may result in a plurality of different containers and dosing assemblies which have been coded differently.
In a SECOND aspect the present invention relates to a medical delivery system comprising:
According to the present invention, different coding variants may be obtained by varying the distribution of the blocking elements and corresponding axially extending indentations along the outline of the coupling parts of the medical delivery system. Thereby it may be ensured that a container of a first medical delivery system is coded such that it cannot be fastened to a dosing assembly of a second medical delivery system. Analogously, it may be ensured that the container of the second medical delivery system is coded such that it cannot be fastened to the dosing assembly of the first medical delivery system. Accordingly, the medical system according to the present invention improves user safety as only predetermined containers may be attached to a specific dosing assembly. Thus, the dosing assembly may be designated to be used with a predetermined kind and/or concentration of a medicament and containers accommodating other concentrations or types of medicaments cannot be attached to the dosing assembly.
The system according to the present invention provides the advantage that dimensions of the coding features as defined by the axially extending indentations can be minimized—even when incorporating a coupling for fastening the container to the dosing assembly following a coupling scheme comprising an axial movement followed by a rotational movement, such as a in a bayonet coupling. This provides the possibility of a larger variety of distinct container codings. In addition, since the coding features of the present invention requires less space, the part of the coding system comprising the indentations can be made more robust compared to systems where fixed male coding elements requires large angular mating female openings. According to the invention, devices may be coded by varying the rotational position of one or more of the blocking element and correspondingly varying the rotational position of corresponding one or more indentations. However, the overall specific user interface for coupling and uncoupling a container from a dosing assembly may be kept identical even for differently coded systems. This is especially beneficial for users that regularly uses several different coded delivery systems for administering different kinds of medicaments.
In the context of the present invention the term “medical delivery system” shall be understood as any system capable of administering a medicament-containing flowable drug. Examples of medical delivery systems are infusion pump applications, dosers, pen-shaped dosers, motor-dosers, and automated syringes such as the AutoPen™.
The invention is applicable to all kinds of medicament delivery devices capable of delivering a medicament to a user from a container which is adapted to be coupled to a dosing assembly of the delivery device. The delivery device may include any delivery device for transcutaneous, subcutaneous, intravenous, intra muscular or pulmonary administration of a drug.
As used herein, the term “medicament” is meant to encompass any medicament-containing flowable drug capable of being passed through a delivery means such as a hollow needle or canula in a controlled manner, such as a liquid, solution, gel or fine suspension. Also lyophilized drugs which prior to administration are dissolved into a liquid form is encompassed by the above definition. Representative medicaments includes pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
The chamber or reservoir of the container may defined by one or more sidewalls of the container and the slidably arranged piston. In most embodiments at least a part of the container is ring-shaped and defines a cylindrical cavity in which the piston is received. The distal end of the container may comprise a seal for penetration by a cannula so as to allow a medicament contained in the chamber to be expelled through the cannula. The distal end of the container may be adapted to be attached to a holder holding a cannula. As an example the distal end of the container may comprise a thread adapted to cooperate with a corresponding thread of the holder so as to allow the holder to be screwed onto the container. Alternatively, the distal end of the container may be adapted to couple to an infusion set.
The outlet of the container may be adapted to cooperate with or be defined by a cannula or a needle or a needle hub or an infusion set, or any other fluid communicating conduit adapted to provide fluid access to a medicament accommodated in the container.
The driver or driving means of the dosing assembly may comprise a piston rod adapted to move the piston in the distal direction. The piston rod may comprise an element which is more rigid than the piston and is adapted to abut at least a part of and preferably most of the proximal facing surface of the piston whereby a force applied by the piston rod to the rigid element is applied to a larger area of the proximal surface of the piston than if the piston rod had engaged the piston directly. The piston rod may be adapted to transfer a driving force to the piston either directly or via other parts situated in the dosing assembly and/or in the container.
The dosing assembly defines a first fastening means which during fastening of the container to the dosing assembly engages a second fastening means of the container. In one embodiment a proximal facing surface of the first fastening means of the dosing assembly engages a distal facing surface of the second fastening means of the container.
The container may be fastened to the dosing assembly through a predetermined movement comprising at least a concurrent axial and rotational movement, such as a helical movement. The rotational movement incurred by the concurrent axial and rotational movement is less than one revolution, such as less than 120 degrees, such as less than 90 degrees, such as less than 60 degrees. When the proximal facing surface of the first fastening means and the distal facing surface of the second fastening means are brought into engagement, rotation of the container relative to the dosing assembly may cause the container and the dosing assembly to be pulled towards each other.
In a first embodiment the first fastening means of the dosing assembly defines a groove adapted to receive a projection defined by the second fastening means of the container. During fastening of the container to the dosing assembly, a substantially proximal facing surface of the first fastening means of the dosing assembly engages a substantially distal facing surface of the container. The predetermined movement is defined by the shape of at least one of the engaging surfaces. In a further embodiment the second fastening means defines a plurality of projections such as two, three or four, and the first fastening means defines a corresponding plurality of grooves adapted to be engaged by the projections.
In a second embodiment the groove(s) is/are defined by the container and the projection(s) is/are defined by the dosing assembly. In a third embodiment the container defines a combination of grooves and projections adapted to be engaged by corresponding projections and grooves defined by the dosing assembly.
In the context of the present invention the terms “groove” and “projection” are only used in connection with the first and second fastening means, and “indentation” and “protrusion” are only used in connection with engaging/receiving mechanism of the rotatable element and the second part extending coding mechanism. However, “groove”, “indentation” and “female member” shall be seen as synonyms and “protrusion”, “projection” and “male member” shall be seen as synonyms.
The first and second fastening means may be adapted to engage in a releasable or permanent manner. Even when the fastening means are adapted to engage by a permanent engagement, the invention provides increased safety against mix-up prior to the final assembling of the medical delivery device, e.g. during fabrication.
In one embodiment the rotatable element defines one or more protrusions or blocking elements (such as two, three, four or five) each of which is adapted to engage a corresponding/mating/matching indentation of the second part. However, the main purpose of the blocking elements is to prevent or limit the axial entry of a container into a container receiving cavity of the dosing assembly. The terms “corresponding/mating/matching” above does not necessarily mean a form fitting engagement, i.e. the indentations may be much wider (in the peripheral direction) than the blocking elements.
In a second embodiment the rotatable element defines one or more indentations (such as two, three, four or five) each of which is adapted to engage a corresponding/mating/matching protrusion of the second part.
In a third embodiment the rotatable element comprises one or more protrusions and one or more indentations. In the latter embodiment, the protrusion(s) of the rotatable element is/are adapted to engage one or more indentations of the second part and the indentation(s) is/are adapted to engage one or more protrusions of the second part.
In a fourth embodiment, the first and second fastening means may be adapted to engage in a releasable or permanent manner. Even when the fastening means are adapted to engage by a permanent engagement, the invention provides increased safety against mix-up prior to the final assembling of the medical delivery device, e.g. during fabrication.
In one embodiment the indentations are wider (circumferentially) than the protrusions or blocking elements, and, thus, the projections or blocking elements are allowed to move rotationally inside the indentations, whereby the second part will be allowed to rotate relative to the rotatable element when the protrusions are received in the indentations without moving the blocking elements from their first position to their second position.
The possible relative rotation between the second part and the rotatable element may be less than 60 degrees about the longitudinal axis of the device, such as less than 45 degrees, such as less than 30 degrees, such as less than 5 degrees, such as less than 1 degree. In another embodiment the possible relative rotation between the rotatable element and the first part is 40-100 percent of the relative rotation between the second part and the first part during fastening of the container to the dosing assembly, such as 60-100 percent, such as 80-100 percent.
The sidewalls of the protrusions may be v-shaped i.e. the width of the sidewall may decrease in the axial direction. Similarly, the indentations may be v-shaped.
In one embodiment the first and second fastening means, and the blocking elements and the indentations are arranged such that the first and second fastening means must at least partly engage in order for the blocking element to be received in the indentation. In other words when fastening the container to the dosing assembly, the blocking elements cannot be received in the indentation(s), if not the projection(s) (of the first or second fastening means) are at least partly received in the groove(s) (of the other of said first or second fastening means).
In one embodiment the dosing assembly defines the one or more blocking elements. In some embodiments the blocking elements protrudes into a container receiving cavity for blocking axial entry of non-allowed containers. In other embodiments, the blocking element protrudes radially outwards for blocking the coupling of a non-allowed dosing assembly into a form-fitting container having a cavity for receiving at least a part of the dosing assembly therein. In still other embodiments, the blocking elements are defined by the container, where the blocking elements protrudes radially into or ourwards from a container wall. In these embodiments, the dosing assembly are provided with axially extending indentations for coding to a correct container.
Still other embodiments include medical delivery devices where both the container and the dosing assembly are provided with each one or more blocking elements to be received in corresponding axially extending indentation(s) of the other part.
In one embodiment, the delivery system comprises two or more blocking elements. The two or more blocking elements may be arranged at irregular mutual distances, e.g. to provide a non-symmetrical coding system arranged around a circumferential portion of the coupling interface.
In one embodiment, the container comprises second fastening means arranged at a distance X1 from the proximal end of the container. The second fastening means may be provided by male members for cooperating with female members of the dosing assembly. An axial extent of a male member may be designated a thickness t1. In such a system, the one or more indentations exceeds the distance X1+t1. In specific embodiments, the distance that said one or more indentations extends in the distal direction exceeds X1+t1 such as by 50%, such as by 75%, such as by 100%, such as by 150%, such as by 200% and such as by 300%.
In some embodiments the second fastening means are arranged at the extreme proximal end of the container.
In one embodiment, the one or more indentations are formed as longitudunally indentations which are recessed compared to neighbouring sections. In such a configuration, the indentations may be provided as a reduced thickness of a wall portion of the container. In other embodiments, the container provides a central cavity arranged in the end face of the proximal end of the container where the indentations extends radially from the central cavity of the container and radially outwards to the container exterior. Thereby the indentations may form openings defined in a side wall of the container.
In one embodiment, the second fastening means are associated with the proximal end of the container. In other embodiments, the second fastening means are associated at a position extending from the proximal end of the container by a given distance, such as midway between the proximal and distal ends or even closer to the distal end of the container. In still other embodiments, the second fastening means are associated with the distal end of the container.
In one embodiment, the one or more indentations extends from the proximal end of the container. In still other embodiments, the indentations extends from a side wall portion of the container distant from the proximal end and extending further towards the distal end.
The protrusion(s) and the indentation(s) may have substantially the same circumferential width. Alternatively, the protrusion may be slightly wider than the indentation and at least one of the protrusion and the indentation may be made of a resilient material.
In one embodiment the rotatable element is locked for rotation relative to the second part during fastening of the container to the dosing assembly, e.g. the possible relative rotation between the rotatable element and the second part is less than 1 degree.
Furthermore, when the container comprises one or more axially extending indentations, the second fastening means may be axially positioned between the distal most surface of at least one of the one or more indentations (i.e. a bottom surface of the indentation), and the proximal end surface of the container.
In one embodiment the first and second fastening means, and the protrusions and the indentations are arranged such that first and second fastening means must at least partly engage in order for the protrusion to be received in the indentation. In other words when fastening the container to the dosing assembly, the protrusion(s) cannot be received in the indentation(s), if not the projection(s) (of the first or second fastening means) are at least partly received in the groove(s) (of the first or second fastening means). Accordingly, the medical device cannot be uncoded by advancing at least a part of the protrusions into the indentations and rotating the rotatable element relative to the first part until the projections could be received in the grooves, whereby the container could be fastened to the dosing assembly.
The rotatable element is adapted to rotate about the longitudinal axis (the centre axis) of the first part and may in some embodiments be locked for axial movement relative to the first part.
In one embodiment the rotation of the rotatable element relative to the first element is a combined rotational and radial movement. In a particular embodiment the rotatable element is moved along a line defining a tangent to a circle, the centre of which coincides with the longitudinal axis (the centre axis) of the device, when the container is fastened to the dosing assembly.
In one embodiment the rotatable element is adapted to be changed between a first and a second rotational position relative to the first part such that prior to fastening of the container to the dosing assembly, the rotatable element is positioned in the first position and when the container is fastened to the dosing assembly the rotatable element is positioned in the second position. In one embodiment the rotatable element is biased towards the first position e.g. by means of a spring.
In one embodiment the dosing assembly defines the first part and thus comprises the rotatable element. In the latter embodiment the rotatable element may be provided on an outer surface of the dosing assembly. Alternatively, the rotatable element may be provided on an inner surface of the dosing assembly.
In an alternative embodiment the container defines the first part and comprises the rotatable element. Again, the rotatable element may be provided on the inner or outer surface of the container.
The protrusions and/or indentation may extend in a substantially axial and/or radial direction of the device. The rotatable element may be a ring-shaped element. The rotatable element may be made of a wire or a piece of sheet metal. The wire and the sheet metal may be bent e.g. by means of a punching apparatus, so as to define the protrusions or indentations. In an alternative embodiment the rotatable element is made of a moulded metal and/or plastic material such as Poly-propen, Poly-carbonat, Poly-oxymethylen. Alternetively, the rotatable element is made by means of a 3d-printing printing process.
In one embodiment the ring-shaped element comprises at least one protrusion and is adapted to contract radially upon advancement of each of the at least one protrusion into the corresponding indentation of the second part. When the ring-shaped element contracts the diameter decreases. Accordingly, in one embodiment the ring-shaped element may abut a surface of the first part prior to advancement of the at least one protrusion into the corresponding indentation of the second part, whereby the ring-shaped element may be rotationally and/or axially retained relative to the first part. When the one or more projections have been advanced into the mating indentations, the ring-shaped element have contracted and is thus not retained relative to the first member as the ring-shaped element no longer abut the ring-shaped element.
In order to provide the contracting effect one or more of the at least one protrusion of the ring-shaped element may be v-shaped and the widest part of the v-shaped part may be wider than the widest part of the matching indentation. Accordingly, when the v-shaped protrusion is forced into the indentation, the sides of the v-shaped protrusion are forced towards each other whereby the ring-shaped element contracts. By providing a ring-shaped element which abut the first part when the container is not fastened to the dosing assembly, it may be ensured that the ring-shaped element will not change rotational position. If the ring-shaped element could change position when the container is not fastened to the dosing assembly, it would not be possible to fasten a predetermined container to a dosing assembly.
Alternatively, or as a supplement, the ring-shaped element may comprise at least one protrusion and may be adapted to expand radially upon advancement of each of the at least one protrusion into the corresponding indentation of the second part. When the ring-shaped element expands, the diameter of the ring-shaped element increases. The expanding effect may be achieved by providing a protrusion defining a loop as will be described in further detail below in relation to the figures.
Moreover, the rotatable element may be retained in relation to the first part by providing at least one radially extending knob on the rotatable element, which knob upon radial contraction or expansion of the rotatable element engages or disengages a depression defined in the first part, whereby the rotatable element is unlocked/locked from the first part and allowed to or prevented from rotate(ing) about a center axis of and relative to the first part. The depression may be defined by two adjacent radially extending knobs between which the depression is defined.
Alternatively, rotatable element may comprise a v-shaped protrusion and a loop-shaped protrusion, whereby advancement of the rotatable element into matching indentations, causes the v-shaped protrusion to contract and the loop-shaped protrusion to expand whereby a knob provided between the two protrusions is caused to rotate. This may be used to rotate the knob out of engagement of a depression.
In order to provide a system wherein the rotational position of the rotatable element defines the coding of the first part, the first part may be adapted to retain the rotatable element in a plurality of predetermined positions. Accordingly during manufacturing the first part, said first part may be coded by choosing a desired rotational position of the rotatable part relative to the first part. This provides the advantage that with the same two elements (the rotatable element and the first part) a plurality of different codes may be achieved.
In one embodiment the container comprises a cartridge holder and a cartridge defining said chamber. The second fastening means may be defined by or attached to the cartridge holder. Moreover, the indentation(s)/protrusion(s)/blocking element(s) may be defined by the cartridge holder. The cartridge and the cartridge holder may be two separate elements, and the cartridge may be frictionally retained in the cartridge holder. In one embodiment the cartridge is made of glass and the cartridge holder is made of a non-glass material for protecting the glass cartridge. The cartridge may be non-removably retained in the cartridge holder, such that if the cartridge is removed from the cartridge holder it cannot be reattached by hand and without tools. This provides the advantage that the cartridge holder cannot be reused when the cartridge has been emptied, accordingly a cartridge with a wrong medicament cannot be inserted into the cartridge holder and be dispensed by use of the dosing assembly. The cartridge holder and the cartridge may define a monolithic element, i.e. forming a one element without seams. Such a monolithic element may be formed as a molded article made of a synthetic resin such as Topas(R) or polypropylene. Such a molded article may include the fastening and coding elements which are formed during molding. However, any material which is suitable for long-term storage of the specific medication to be accommodated in the container may be used.
As described in above at least a part of said predetermined movement may be a concurrent axial and rotational movement. Moreover, at least one of:
Moreover, the coding geometry of:
Accordingly, it will be appreciated that the medical delivery system according to the present invention provides a plurality of coding geometries each of which may be used to designate different features. As an example the first and second fastening means may be used to designate a first predetermined feature of the medicament such as its kind, and the rotational position of the rotatable element may be used to designate a second predetermined feature of the medicament such as its concentration. Other examples of features which may be designated by a coding geometry are: male/female medication; child/adult medication; prophylactic/therapeutic medication, slow/fast acting medication.
Alternatively, the first and second fastening means, and the rotational position of the rotatable element may be redundant such that if one of them fails, the other one will ensure that only predetermined containers and dosing assemblies can be fastened to each other. Accordingly, an extra level of security is provided due to the two redundant coding geometries.
One embodiment comprises:
Moreover, the predetermined movement required for coupling and uncoupling the first container to the first dosing assembly and for coupling the second container to the second dosing assembly may be essentially the same.
In a THIRD aspect the present invention relates to a container suitable for use (adapted to be used) in a medical delivery system according to the first aspect of the invention.
It will be appreciated that the invention according to the second aspect may comprise any feature and/or element of the invention according to the first aspect. In particular the container of the second aspect may comprise any feature and/or element of the container according to the first aspect of the invention.
In a FOURTH aspect the present invention relates to a dosing assembly suitable for use (adapted to be used) in a medical delivery system according to the first aspect of the invention.
It will be appreciated that any of the aspects/embodiments described herein can comprise any feature and/or element of other aspects/embodiments described herein. Thus, it will be appreciated that the invention according to the second, third, and/or fourth aspect may comprise any feature and/or element of the invention according to the first aspect. In particular the dosing assembly of the fourth aspect may comprise any feature and/or element of the dosing assembly according to the first aspect of the invention.
The invention will now be described in further detail with reference to the drawings in which:
a, 33b, 33c show two specific container coupling systems according to a first embodiment of the present invention,
a discloses a container coupling system according to a third embodiment of the invention,
b and 35c disclose two alternative container designs according to the third embodiment of the invention,
a, 36b, 36c, 36d and 36e disclose a container coupling system according to a fourth embodiment of the invention, and
a and 37b shows a container coupling system according to a fifth embodiment of the invention.
In
During fastening of the container to the dosing assembly the following occurs. The container is moved axially towards the dosing assembly. Subsequently the two elements are rotated relative to each other until the first and second fastening means (the projections and the groove) start to engage whereupon the protrusions start to be received in the indentations. Upon further relative rotation, the dosing assembly is moved towards the container, whereby the protrusions 118 are advanced further into the indentations 120. As the indentations rotate (due to the rotation of the container) the rotatable element 106 is caused to rotate relative to the dosing assembly.
In order to ease receipt of the protrusions 118 in the indentations 120, the sidewalls of the protrusions 118 define inclined surfaces 124 (as shown in
It will be appreciated that the relative rotational position between the first/second fastening means and the indentations/protrusions determines whether a predetermined container 102 may be attached to a predetermined dosing assembly 104. In
When the dosing assembly and the rotatable element are assembled the rotatable element is temporarily retained rotationally relative to the dosing assembly by means of the knob 126 which engages corresponding knobs (not shown) in the dosing assembly, whereby the rotatable element may be retained in a predetermined number of positions. Alternatively, the rotatable element may be retained temporarily and relative to the dosing assembly due to notch 127 (shown in
According to an alternative embodiment (not shown), the rotatable element may be biased by a spring member towards a fixed rotational position relative to the first fastening means so that correct alignment between the rotatable element and the first fastening means will be automatically obtained, no matter whether the rotatable element has been tampered with. Such biasing means may be provided in addition to the abovementioned knob 126 or notch 127.
The proximal surface part of the second fastening means 110 may be positioned at a distance X1 from the extreme proximal part of the container 102. In some embodiments of the present invention, this distance X1 is minimized, or ultimately, the proximal surface part of the second fastening means defines the proximal end of the container.
The axial extent of the male member forming the second fastening means 110 is defined by the parameter t1.
In some embodiments, the axial length of the indentation 120 from the proximal end of the container 102 will be longer than X1+t1. Typically, an indentation length will be greater than the parameter X1+t1, such X1+t1 plus 50%, such as X1+t1 plus 100% such as X1+t1 plus 200%, such as X1+t1 plus 300%.
In order to provide a thin and rigid rotatable element, the rotatable element may be made from punched sheet metal which may be bent one or more times in order to provide the desired shape.
In
In the depicted form, the container 2 is defined by a cartridge holder 2″ adapted to receive a medicament containing cartridge 2′, e.g. a standard glass cartridge. The container 2 is provided with fastening means (not shown) for fastening the container 2 to the dosing assembly 4 of the injection pen.
The fastening means of the container 2 is adapted for engaging fastening means of the dosing assembly 4 and the coupling may provide a permanent coupling which renders cartridge removal impossible, thereby forming a prefilled pen which may be disposed off after medicament contained in the cartridge has been emptied.
Alternatively, the fastening means of the container 2 and the fastening means of the dosing assembly 4 may form a releasable connection which then provides the possibility of reusing the dosing assembly with a new container after a previous empty container has been disposed off.
In accordance with the general delivery device concept outlined above, a recent state of the art syringe device has been marketed by the applicant as “NovoPen® 4”. This device provides a durable dosing assembly which is adapted to accept disposable medication cartridges which can be easily exchanged by a user. The specific coupling mechanism for coupling a cartridge holder to the dosing assembly of the NovoPen® 4 offers a simple, intuitive and reliable coupling.
The distal part 102 comprises two male members or projections 110 arranged on each side of the distal part 102. These projections 110 are used to secure the distal part 102 to the proximal part 104, by advancing the projections 110 into matching tracks forming grooves 112 of the proximal part 104. The grooves 112 are defined inside the cartridge receiving cavity 150 on an inner surface of the proximal part 104. The specific shape of each of the grooves 112 are defined by neighbouring ramp shaped ridges 114 protruding radially into the cartridge receiving cavity 150. Each of the grooves are defined by a first part having an opening for accepting axial entry of the distal part 102 by allowing the projections 110 to enter corresponding openings when the proximal part 104 and the distal part 102 are properly aligned. The opening of the grooves 112 are followed by slopes gradually transferring into grooves running along the inner peripheral direction, i.e. defined by a proximal facing surface 115. This arrangement provides a fastening movement between distal and proximal parts 102 and 104 comprising an initial relative axial movement, followed by a combined axial and rotational movement and ending in an exclusive rotational movement.
a and 33b discloses exploded views of coupling parts of a first embodiment of a medical delivery system according to the present invention. Here, 200 denotes a medical delivery system comprising a container 202 (for simplicity reasons, the distal end of the container has been omitted in the drawing), and a dosing assembly 204 (of which only specific parts related to the distal part is disclosed). The dosing assembly 204 comprises a first fastening means 212 defining a groove for receiving a male member or projection defining a second fastening means 210 provided on the container 202. The groove of the first fastening means 212 defines an opening into which the male member of the second fastening means 210 can be inserted when the container 202 is properly aligned for axial entry into cartridge receiving cavity 250. The container 202 may be fastened to the dosing assembly by advancing the projection into the groove whereby a distal facing surface 211 of the projection (the second fastening means 210) engages a proximal facing surface 215 of the groove (the first fastening means 212). Upon relative rotation between the dosing assembly 204 and the container 202 the two elements are pulled towards each other due to the engagement between the distal facing surface 211 and the proximal facing surface 215. Due to the angular extent of the groove the two elements can only be rotated a limited angle relative to each other i.e. less than one revolution.
In the embodiment shown, the number of distinct pairs of fastening elements 210 and 212 are selected as two. However, the number of distinct pairs of fastening elements 210 and 212 may be selected from 1 to 6. Also, the peripheral distribution of the fastening elements may be organized as evenly distributed along the periphery, or may be distributed unevenly and non-symmetrical.
As in syringe device 100, the medical delivery system 200 may be adapted for coupling container 202 to dosing assembly 204 by a fastening sequence comprising an initial relative exclusive axial movement, followed by a combined axial and rotational movement and ending in an exclusive rotational movement. As an alternative, the fastening sequence may comprise a relative axial movement followed by an exclusive rotational movement, i.e. forming a conventional bayonet coupling.
a also shows two spring elements 207 which now will be described in connection with
The number of blocking elements in a specific medical delivery system may be selected from 1 to 4 or even more separate blocking elements.
As seen in
The indentations 220 of container 202 are adapted to receive the blocking elements 206 when the container is inserted axially into container receiving cavity 250 of dosing assembly 204. In the shown embodiment, when the container has been inserted axially into container receiving cavity, the shape of the indentations 220 or the peripheral dimension of the indentations 220 are adapted to exert a force on the blocking elements when the fastening movement commences the angular movement. Thereby, the wall part of the container positioned next to an indentation exerts a force for moving the blocking elements 207 from the first position and radially outwards responsive to the angular movement of container 202 relative to the dosing assembly 204.
c shows a second variant of the first embodiment of the invention where medical delivery system 200′ is adapted to administer a second medicament which is different than the first medicament administrable by medical delivery system 200. Here the relative angular orientation of the indentations 220′ with respect to the second fastening means 210′ of the container 202′ is different than in container 202. As in medical delivery system 200, the orientation of axial indentations 220′ along the peripheral part of the container 202′ relative to the second fastening means 210′ of container 202′ corresponds to the angular orientation of the blocking elements 206′ relative to the openings of the first fastening means 212′. Consequently, the container 202′ is fully axially insertable into container receiving cavity 250′ of dosing assembly 204′ and also able to be rotated as defined by the specific fastening movement scheme.
In order to prevent mix-up of different container medicaments and non-matching or non-allowed dosing assemblies, containers 202, 202′ each having a specific distribution of coding features, e.g. the second fastening means 210, 210′ and indentations 220, 220′, are dedicated specific coding features according to the medicament contained in each cartridge. Likewise, each dosing assembly 204, 204′ is provided with specific corresponding coding features, e.g. first fastening means 212, 212′ and blocking elements 206, 206′.
Attempting to insert the container 202′ into container receiving cavity 205, the second fastening means 210′ of container 202′ may be aligned with the openings formed in first fastening means 212 of dosing assembly 204. However, when this condition is fulfilled, it is not possible to align the indentations 220′ of container 202′ with blocking elements 206 of dosing assembly 204. Due to the blocking elements 206 being able to resist axial directed forces without being moved, the proximal rim part of container 202′ will be blocked for axial entry of container 202′ into container receiving cavity 250 and, thus, the user will readily acknowledge that container 202′ is not the correct type for coupling to the dosing assembly 204. The same conditions apply if the user attempts to insert the container 202 into dosing assembly 204′. Similarly, both of the assemblies 204 and 204′ are designed to reject a cartridge holder having no indentations. Also, by correct design of the containers 202 and 202′, e.g. the second fastening means 210 and 210′, it is assured that neither of the containers 202 and 202′ are compatible with a dosing assembly designed to accept a cartridge having no indentations. In this way, a 1-to-1 coding scheme is provided which prevents drug mix-up.
In accordance with the present invention, it is ensured that the coding elements of the container, e.g. the indentations 220, can be designed as relatively narrow axially extending slots and thus provide a sturdy container where the required area reserved for coding purposes are minimized. Also, this design ensures that a large number of distinct codes can be obtained by offering a large number of possible angular positions for the coding elements defined by the indentations 220.
As best seen in
The proximal surface part of the second fastening means 210 may be positioned in a distance X1 from the extreme proximal part of the container. In some embodiments of the present invention, this distance X1 is minimized, or ultimately, the proximal surface part of the second fastening means defines the proximal end of the container. By positioning the blocking elements 206, so that the distal part of a blocking element 206 is further away from the land 240 in the proximal direction than the distance X1, it is ensured that the blocking elements 206 cannot be manipulated by the extreme proximal part of the container when a user performs the first initial angular alignment of container 202 and dosing assembly 204. At the same time, the distal part of the blocking elements 206 are preferably positioned so that the blocking elements 206 blocks axial entry of a wrong cartridge before the level is reached where the angular fastening movement commences as defined by the first and second fastening means. Accordingly, indentations 220 of a correct container 202 are designed for full axial insertion into the container receiving cavity 250. However, in observing these requirements, it is preferred that the distal end of the blocking elements 206 are positioned as close as possible to the above described distance X1.
Typically, if the axial extent of the male member forming the second fastening means 210 is defined by the parameter t1, the total axial movement that the container is moved from the point of entry into the first fastening means 212 (which corresponds to the position of the land 240) and towards the fully inserted position is roughly twice the parameter t1 or even more.
When the distal part of the blocking member is arranged in the vicinity of land 240, the indentations 220 preferably has a minimum length of in the order of two times t1. However, if the fastening movement scheme comprises a combined axial and rotational movement, this minimum indentation length may become shorter. Typically, the axial length of the indentation from the proximal end of the container 202 will be longer than t1, and eventually, if the male member of the second fastening means are arranged at a distance from the proximal end of the container, the axial length of the indentations will be longer. Typically, an indentation length will be greater than the parameter t1, such as t1 plus 30%, such as t1 plus 50%, such as t1 plus 100% such as t1 plus 200%, such as t1 plus 300%.
According to a second embodiment of the invention,
When fitted into dosing assembly 304, the element 306 forms a blocking element having a movable part which has a first unbiased position (the rest position which corresponds to the orientation shown in
The movement of the blocking element 306 may be limited by additional not shown guide surfaces which prevents the central part of the blocking element 306 to be moved in the proximal direction. This may be accomplished by a not shown part of the dosing assembly, which is situated inside the container receiving cavity 350. Also, the unbiased position may be provided by forming guide surfaces of the dosing assembly 304 to cooperate with the blocking element for forcing the blocking element into its rest position.
A third embodiment is shown in
According to the various embodiments of the invention, the indentations 220, 320, 420, 520 of the container may take many different forms which is considered within the scope of the appended claims. Also, the indentations 420 may be formed as openings extending entirely from a central cavity of the container (which is adapted to receive driving means of the dosing assembly 404) and radially outwards towards an external peripheral wall surface of the container 402. Alternatively, according to the specific design of the blocking element 406 and the dosing assembly 404, the indentations do not extend completely from the internal cavity of the container to the exterior wall surface, but may be formed as recessed areas in the wall part thereby forming areas of reduced thickness relative to neighbouring areas.
a-36e shows different embodiments of a container and dosing assembly, the dosing assembly having a blocking element 506 formed as a unitary part of the container receiving portion of the dosing assembly, where the blocking element 506 forms a flexible part allowed to flex along a hinge section defined as a hinge rotating along an axis extending parallel with the central axis of the pen. Alternatively, the blocking element, due to its elastic nature, may be deformed over the entire blocking element section. In the shown embodiment, in order to force the blocking element 506 into its rest position where the central blocking element extends into the container receiving cavity, the flexible member has a spring member 507 attached for exerting an inwardly directed force upon blocking element 506.
b show a similar construction to the one shown in
e and 36d shows specific details a dosing assembly, and more specifically of a distal surface of the blocking element 506. In order to prevent outward movement of the blocking member 506 if a proximal rim part of a container should inadvertently be rotated while contacting the distal surface of the blocking member 506, the blocking member may be provided with a groove 508 into which the rim part of the container may be forced. Alternatively, a protrusion 509 may beformed which is arranged at a smaller distance from the cartridge center than the internal wall face of a container. By these provisions, the blocking member may be locked in its first (rest position) thereby only accepting correct containers.
A further embodiment is shown in
Further not shown embodiments include solutions where the container part of the medical delivery system is provided with one or more flexible members forming blocking members as outlined above. In such configurations, the dosing assembly needs to be equipped with corresponding indentations for the dosing assembly to be assigned to each specific container.
Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims. The figure e.g. discloses medical delivery systems of the present invention in the form of an injection pen, however, this particular delivery device and its shape is in no way limiting for the present invention as defined in the claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 06014769.1 | Jul 2006 | EP | regional |
| 06118846.2 | Aug 2006 | EP | regional |
This application is a continuation-in-part of U.S. application Ser. No. 12/373,340, filed Jan. 12, 2009, which is a 35 U.S.C. §371 national stage application of International Patent Application PCT/EP2007/057283 (published as WO 2008/009646), filed Jul. 15, 2007, which claimed priority of European Patent Applications 06014769.1, filed Jul. 15, 2006, and 06118846.2, filed Aug. 14, 2006; this application further claims priority under 35 U.S.C. §119 of U.S. Provisional Application 60/837,726, filed Aug. 14, 2006, all of which are incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60837726 | Aug 2006 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12373340 | Feb 2009 | US |
| Child | 12357013 | US |
