CN101511411A

CN101511411A - A medical delivery system with flexible blocking element

Info

Publication number: CN101511411A
Application number: CNA2007800328673A
Authority: CN
Inventors: A·V·克里斯琴森
Original assignee: Novo Nordisk AS
Current assignee: Novo Nordisk AS
Priority date: 2006-07-15
Filing date: 2007-07-15
Publication date: 2009-08-19
Anticipated expiration: 2027-07-15
Also published as: CN101511411B; CN101489607B; CN101489607A

Abstract

A medical delivery system (200) having a container (202) and a dosing assembly (204), where the container is fastenable to the dosing assembly by a movement comprising a translatory movement followed by a rotational movement. One of the container and the dosing assembly comprises one or more blocking elements (207) movable between a blocking position and a non-blocking position responsive to the rotational movement. Each blocking element is able to engage the other one of the container and the dosing assembly. A container suitable for use in said medical delivery system.

Description

Medical delivery system with flexible barrier member

Technical Field

[0001] The invention relates to a medical delivery system comprising a container and a dosing assembly. In particular, the present invention relates to a medical delivery system wherein one of the container and the dosing assembly comprises a flexible blocking member adapted to engage the other of the container and the dosing assembly. Furthermore, the invention relates to a container and a dosing assembly, each of which is suitable for use in a medical delivery system according to the invention.

Background

[0002] Generally, in order to provide a good medical delivery device which is easily accepted by a specific patient population, considerable differences are set in the drug delivery system for ease of use by the patient. As the number of commercial delivery systems increases, a number of different types of medication storage tubes or containers are dispensed. Most of these types of containers differ in various respects.

[0003] Each drug container may be filled with a particular type of drug selected from a large number of different drugs, while the container may also be filled with different types of the same type of drug (e.g. fast or long acting insulin) and different concentrations of each particular drug.

[0004] Furthermore, different container volumes may be introduced, thereby personalizing each container, and thus the delivery system, to the needs of a particular user. The change in volume of the container may be provided by changing the length or diameter of the container. These changes typically involve corresponding changes to the dosing assembly of the medical delivery system to provide a specific stroke of the drive member to eject the drug from the container or to provide alternative dosing accuracy. Further differentiation between different medicament containers may also be achieved by the design requirements of each particular delivery system, such as the sliding friction requirements of a piston provided in the container.

[0005] In order to distinguish between the more available containers, a number of container coding systems have been developed, which are mainly based on electronic reading and recognition of a specific container so that a specific type of medication is delivered by a dedicated delivery device. The following mechanical coding systems are known in the art:

[0006] US5611783 relates to a pen injector comprising a distal end with an ampoule and a proximal end with an ingredient setting and drive mechanism. The proximal and distal ends have interlocking bayonet coupling means. The protrusions are provided to form a pattern that ensures that a particular distal end can only be used in conjunction with a particular proximal end.

[0007] WO03/017915A1 discloses a cartridge having a distal end provided with a mechanical coding. The mechanical coding has the form of a circular protrusion, wherein the circular outer diameter is dedicated to a specific concentration of insulin contained in the cartridge.

[0008] US5693027 discloses a plastic cap for adapting a standard cartridge to a selected syringe. The plastic cap may have a means for wedge-like engagement with a corresponding means in the injector to prevent rotation when assembled with a cartridge in the injector.

[0009] US6648859B2 discloses a cartridge device for a reusable pen-like device for a medical delivery pen. To eliminate cross use, the pen-like means and the cartridge are wedge-shaped, i.e. they may be threadedly engaged by corresponding threads and grooves, mating threads and grooves, a pair of protrusions that snap-fit or mate in a reverse Luer-Lock fashion. The mating part is selected to prevent cross use with other devices, for example the pitch of the thread is angled to mate only with the corresponding other part and not with other devices.

[0010] Another prior art system is disclosed in DE 20110690.

[0011] It is an object of a preferred embodiment of the present invention to provide an alternative to known systems. It is furthermore an object of a preferred embodiment of the present invention to provide a medical delivery system with a number of possible coding structures.

[0012] It is furthermore an object of a preferred embodiment of the present invention to provide a coding system wherein a user experiences substantially the same fastening movement operation when coupling/uncoupling a container and a dosing assembly of a predetermined medical delivery system to/from each other, irrespective of the specific choice among sets of compatible containers, dosing assemblies. It is also an object of a preferred embodiment of the present invention to provide a system having a number of differently coded containers/dosing assemblies, while resulting in a robust system with reduced potential for mechanical failure.

[0013] Furthermore, it is an object of a preferred embodiment of the present invention to provide an intuitive securing mechanism for securing a container to a dosing assembly.

Summary of The Invention

[0014] In a first aspect, the present invention relates to a medical delivery system comprising:

-a container comprising a housing adapted to be filled with a drug in a cavity and a slidably arranged piston which is movable in a distal direction towards an exit opening to reduce the volume of the cavity and to expel the drug through the exit opening;

-a dosing assembly having a container receiving cavity for at least partially receiving the container therein and coupling the container to the dosing assembly such that a drive arrangement of the dosing assembly moves a piston of the container in the distal direction.

Wherein the dosing assembly forms a first fastening means for engaging a second fastening means of the container to secure the container to the dosing assembly, wherein the securing movement comprises a relative axial movement along a first axis followed by a relative rotational movement about the first axis.

Wherein the dosing assembly comprises one or more blocking members, wherein said one or more blocking members are movable from a first position in which they extend radially relative to said first axis into said container receiving cavity, towards a second position in which they are moved radially outwardly, wherein the blocking members are movable from said first position to said second position in response to said relative rotational movement, while being prevented from moving from said first position to said second position when an axial external force is applied; and wherein the container comprises a container wall portion formed with axially extending indentations for receiving said predetermined number of blocking members and for axially inserting the container into said container receiving cavity.

[0015] According to the invention, different coding variants can be obtained by varying the distribution of the blocking elements and the corresponding axially extending indentations along the contour of the coupling part of the medical delivery system. It is thereby ensured that the container of the first medical delivery system is coded such that it cannot be fixed to the dosing assembly of the second medical delivery system. Similarly, it may be ensured that the container of the second medical delivery system is coded such that it cannot be fixed to the dosing assembly of the first medical delivery system. The medical system according to the invention thus improves user safety, since only predetermined containers can be connected to a specific dosing assembly. Thus, the dosing assembly may be set to use a predetermined type and/or concentration of medicament, whereas containers containing other concentrations or types of medicament cannot be connected to the dosing assembly.

[0016] The system according to the invention has the advantage that: even if a connector is included to secure the container to the dosing assembly, including axial movement and subsequent rotational movement, for example in the case of a bayonet engagement, the size of the coding feature defined by the axially extending indentation may be reduced. This provides the possibility of more different container codes. Furthermore, because the coding feature of the present invention requires less space, the portion of the coding system containing the notch can be made more stable relative to systems that require a larger angle mating notch for securing the male coding member. According to the invention, the device may be encoded by changing the rotational position of one or more blocking members and correspondingly changing the rotational position of the corresponding one or more indentations. However, the entire specific user interface for coupling and decoupling the container to and from the dosing assembly may remain consistent even for differently coded systems. This is particularly advantageous for users who need to use a plurality of differently coded delivery systems often to administer different types of drugs.

[0017] Throughout the present invention, the term "medical delivery system" is to be understood as any system capable of administering a drug comprising an ambulatory agent. Examples of medical delivery systems are infusion pump devices, dispensers, pen dispensers, powered dispensers and auto injectors such as autopen (tm).

[0018] The present invention is applicable to all types of medical delivery systems capable of delivering a medicament in a container adapted to be coupled to a dosing assembly of the delivery device to a user. The delivery device may comprise any delivery device for transdermal, subcutaneous, intravenous, intramuscular or pulmonary administration.

[0019] As used herein, the term "medical" is intended to encompass any drug, including flowable medicaments such as liquids, solutions, gels or fine suspensions, capable of being controllably delivered by a delivery device such as a hollow syringe or catheter. Also lyophilized drugs that dissolve in liquid form prior to administration are encompassed by the above definition. Representative drugs include pharmaceuticals such as peptides, proteins (e.g., insulin-like 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.

[0020] The cavity or reservoir of the container may be formed by one or more side walls of the container housing and a piston arranged to slide. In most embodiments, at least a portion of the container is annular and forms a cylindrical cavity to receive the piston. The distal end of the container may include a seal for being passed through by the cannula to expel the drug in the cavity through a delivery device such as a cannula or catheter. The distal end of the container may be adapted to attach to a holder holding a cannula. For example, the distal end of the container may include threads adapted to mate with corresponding threads of the bracket so that the bracket may be screwed onto the container. Alternatively, the distal end of the container may be adapted to couple to an injection device.

[0021] The discharge outlet of the container may be adapted to cooperate with or be defined by a cannula or needle hub or infusion device, or any other fluid transfer conduit adapted to provide fluid access to the medicament in the container.

[0022] The drive means of the dosing assembly may comprise a piston rod adapted to move the piston in the distal direction. The piston rod may comprise a member which is harder than the piston and which is adapted to abut at least a part, preferably a substantial part, of the proximally facing surface of the piston, thereby enabling the force applied by the piston rod to the rigid member to be applied to a larger area of the proximal surface of the piston than if the piston rod were to directly engage the piston.

[0023] The dosing assembly forms a first fastening means which engages with a second fastening means of the container during fastening of the container to the dosing assembly. 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.

[0024] The coupling process for coupling the container to the dosing assembly may comprise simultaneous axial and rotational movements, such as a screw movement. The rotational movement resulting from the simultaneous 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, such as less than 30 degrees, such as less than 20 degrees. When the proximal facing surface of the first fastening means engages the distal facing surface of the second fastening means, the urging of the container relative to the dosing assembly may cause the container and the dosing assembly to be urged relative to each other.

[0025] In a first embodiment the first fastening means of the dosing assembly forms a recess adapted to receive a protrusion or male part formed by the second fastening means of the container. During fixing of the container to the dosing assembly, a majority of the proximal facing surface of the first fastening means of the dosing assembly engages with a majority of the distal facing surface of the container. The predetermined movement is defined by the shape of the at least one engagement surface. In another embodiment the second fastening means forms a plurality of protrusions, for example two, three or four, and the first fastening means forms a corresponding plurality of recesses adapted to engage with the protrusions.

[0026] In a second embodiment, the recess is formed by the container and the protrusion is formed by the dosing assembly. In a third embodiment, the container forms a combination of recesses and protrusions adapted to engage with corresponding protrusions and recesses formed by the dosing assembly.

[0027] Throughout the present invention, the terms "groove" and "protrusion" are used only in relation to the first and second fastening means, and the "indentation" and "protuberance" are used only in relation to the engaging/receiving means and the second part extending coding means of the rotation member. However, "groove," "indentation," and "concave feature" should be considered synonymous, and "bump," "protrusion," and "convex feature" should be considered synonymous.

[0028] The first and second fastening means may be adapted to be releasably or permanently engaged. Even when the fastening means are adapted to engage in a permanent engagement, the present invention may enhance the safety, e.g. during manufacturing, before the final assembly of the medical delivery device with respect to mixing.

[0029] In one embodiment, the number of blocking members is selected to be one, two, three, four or five, each of which is adapted to engage a corresponding/mating/matching indentation of the second portion. However, the main purpose of the blocking member is to prevent or limit axial entry of the container into the container receiving chamber of the dosing assembly. The above term "corresponding/fitting/matching" does not necessarily mean a form-fitting engagement, i.e. the indentation may be wider (in the circumferential direction) than the blocking part.

[0030] In one embodiment, the indentation is wider (circumferential) than the blocking member such that the blocking member is rotatably movable into the indentation such that when the protuberance is received into the indentation, the second portion can rotate relative to the rotatable member without moving the blocking member from its first position to its second position.

[0031] In other embodiments, the blocking member and the notch may have substantially the same peripheral width. Alternatively, the blocking member may be slightly wider than the gap.

[0032] In one embodiment, the first and second fastening means and the blocking member and the indentation are adapted such that the first and second fastening means must at least partially engage in order for the blocking member to be received in the indentation. In other words, the blocking member cannot be received in the indentation when the container is fixed to the dosing assembly, otherwise the protrusion (of the first or second fastening means) is at least partially received in the recess (of the other of said first or second fastening means).

[0033] In one embodiment, the dosing assembly forms the one or more blocking members. In some embodiments, the blocking member extends into the container-receiving cavity to block unauthorized axial entry of the container. In other embodiments, the blocking member extends radially outward to block the unauthorized dispensing unit from coupling to a cooperatively shaped container having a cavity for receiving at least a portion of the dispensing unit therein. In other embodiments, the blocking member is formed by the container, wherein the blocking member projects radially inwardly or outwardly from the container wall. In these embodiments, the dosing assembly has an axially extending indentation for coding the correct container.

[0034] Other embodiments include medical delivery devices wherein the container and the dosing assembly each have one or more stop members for receipt by a corresponding axially extending indentation of the other part.

[0035] In one embodiment, the transport system comprises two or more barrier members. The two or more blocking members may be arranged at irregular mutual spacings, for example to provide an asymmetric coding system arranged around a circumferential portion of the coupling interface.

[0036] In one embodiment, the container comprises a second fastening means arranged at a distance X1 from the proximal end of the container. The second fastening means may be provided by a male part for cooperation with a female part of the dosing assembly. The axial length of the male member may be expressed as a thickness t 1. In such a system, the one or more notches exceed the distance X1+ t 1. In particular embodiments, the one or more indentations have an eye distance in the distal direction that exceeds X1+ t1, e.g., 50%, 75%, 100%, 150%, 200%, or 300%.

[0037] In some embodiments, the second fastening means is provided at the proximal most end of the container.

[0038] In one embodiment, the one or more indentations are formed as longitudinal indentations that are concave compared to adjacent portions. In this configuration, the indentation may be provided as a reduced thickness of the container wall portion of the container. In other embodiments, the container provides a central lumen disposed in the proximal end face of the container, wherein the indentation extends radially from the central lumen of the container and radially outward to the exterior of the container. So that the indentation may constitute an opening formed in the side wall of the container.

[0039] In one embodiment, the container comprises a cartridge holder and a cartridge forming said cavity. The second fastening means may be formed by or connected to the cartridge holder. Furthermore, the indentation/blocking means may be formed by the cartridge holder. The cartridge and the cartridge holder may be two separate parts, in which the cartridge may be frictionally held. In one embodiment, the cartridge is made of glass and the cartridge holder is made of a non-glass material to protect the glass cartridge. The cartridge may be immovably held in a cartridge holder to prevent damage. Even if such a cartridge is to be removed from the cartridge holder, it cannot be mounted again by hand and with a different tool. This provides the advantage that the cartridge holder cannot be used again when the cartridge is emptied, and therefore a cartridge with the wrong medicament cannot be inserted into the cartridge holder and dispensed by using the dosing device. The cartridge holder and the cartridge may form one integral part, i.e. constitute one part which does not need to be joined. Such an integral part may be formed as a molded article made of a synthetic resin such as a cycloolefin copolymer such as topas (r) or made of polypropylene. However, any material suitable for long-term storage of the particular medicament contained in the container may be used.

[0040] In one embodiment, the second fastening means is associated with the proximal end of the container. In other embodiments, the second fastening means is associated at a position extending a given distance from the proximal end of the container, for example halfway between the proximal end and the distal end or closer to the distal end of the container. In other embodiments, the second fastening means is associated with the distal end of the container.

[0041] In one embodiment, the one or more indentations extend from the proximal end of the container. In other embodiments, the notch extends from a sidewall portion of the container distal to the proximal end and extends further toward the distal end.

[0042] As mentioned above, at least a part of the predetermined movement may be a simultaneous axial and rotational movement. In addition to this, the present invention is,

the first and second fastening means, and

-a stop member and/or a notch of each of the rotatable member and the second part

May be adapted to prevent a portion of the axial and/or rotational movement in the predetermined movement, thereby preventing the container from being coupled to the dosing assembly, unless:

-each of the first and second fastening means forms a predetermined coding shape, and/or

-each of the blocking parts and/or indentations forms a predetermined coding shape.

[0043] In addition to this, the present invention is,

-one or more of the first and/or second fastening means, and/or

-one or more of the blocking member and/or the indentation

The coded shape of (a) may be formed from at least one of: the circumferential extent of the first and second fastening means, the axial length of the first and second fastening means, the radial width of the first and second fastening means, and the peripheral location of the first and second fastening means.

[0044] It will thus be appreciated that a medical delivery system according to the present invention provides a plurality of coded shapes, each of which may be used to represent a different characteristic. For example, the first and second fastening means may be used to indicate a first predetermined characteristic of the drug, such as its kind, and the rotational position of the blocking member may be used to indicate a second predetermined characteristic of the drug, such as its concentration. Other examples of features that can be represented by coded shapes are: male/female drugs, pediatric/adult drugs, prophylactic/therapeutic drugs, slow-release/rapid-acting drugs.

[0045] Alternatively, the rotational positions of the first and second fastening means and the blocking member may be repeated, so that if one fails, the other will ensure that only the intended container and dosing assembly can be secured to each other. Thus, a higher level of security is provided due to the two repeated coding shapes.

[0046] One embodiment includes:

-a first container having any one of the above features and/or components, the first container being adapted to be secured to a first dosing assembly having any one of the above features and/or components; and

-a second container having any one of the above features and/or components, the second container being adapted to be secured to a second dosing assembly having any one of the above features and/or components; and

wherein,

-a first fastening means of the dosing device,

-second fastening means of the container, and

-each of the blocking parts and/or indentations

Is adapted to prevent the first dosing assembly and the second container from being secured to each other and to prevent the second dosing assembly and the first container from being secured to each other.

[0047] Furthermore, the predetermined movement required for coupling and uncoupling the first container to the first dosing assembly is substantially the same as the predetermined movement required for coupling and uncoupling the second container to the second dosing assembly.

[0048] In a second aspect, the present invention relates to a container suitable for use in (arranged for use in) a medical delivery system according to the first aspect of the invention.

[0049] It will be appreciated that the invention according to the second aspect may comprise any feature and/or component of the invention according to the first aspect. In particular, the container of the second aspect may comprise any feature and/or component of the container according to the first aspect of the invention.

[0050] In a third aspect, the present invention relates to a dosing assembly suitable for use in a medical delivery system according to the first aspect of the present invention.

[0051] It will be appreciated that the invention according to the third aspect may comprise any feature and/or component of the invention according to the first aspect. In particular, the dosing assembly of the third aspect may comprise any feature and/or component of the dosing assembly according to the first aspect of the invention.

Drawings

[0052] The invention will be explained in more detail below with reference to the accompanying drawings, in which:

[0053] figure 1 shows a prior art medical delivery system,

[0054] figures 2 and 3 illustrate a prior art container coupling system,

[0055] figures 4a, 4b and 4c show two particular container coupling systems according to the first aspect of the invention,

[0056] figure 5 discloses a container coupling system according to a second embodiment of the invention,

[0057] figure 6a discloses a container coupling system according to a third embodiment of the invention,

[0058] figures 6b and 6c disclose two alternative container designs according to a third embodiment of the invention,

[0059] figures 7a, 7b, 7c, 7d and 7e disclose a container coupling system according to a fourth embodiment of the present invention, and

[0060] fig. 8a and 8b show a container coupling system according to a fourth embodiment of the present invention.

[0061] Fig. 1 discloses a medical delivery system constituting an injection pen 1, comprising a container part 2 containing a medicament, which is adapted to be fixed to a dosing assembly 4. In the form shown, the dosing device 4 constitutes a mechanism for setting and injecting a specific dose of medicament in the container 2. The container 2 comprises an open distal portion which is sealed by a pierceable sealing member 5. The container further comprises a slidably mounted piston 11 adapted to move towards the distal part of the container 2 east when a force is applied to the piston 11 in the distal direction. Typically, the medicament is delivered through a needle cannula 3 releasably secured to the distal portion of the container 2. When the container 2 is coupled to the dosing assembly 4, the external force exerted by the drive means 7 of the dosing assembly is transferred to the piston 11, thereby expelling the medicament in the container 2 through the needle cannula 3.

[0062] In the shown figures, the container 2 is defined by a cartridge holder 2 ″ adapted to receive a cartridge 2' containing a drug, e.g. a standard glass tube. The container 2 has fastening means (not shown) to secure the container 2 to the dosing assembly 4 of the injection pen.

[0063] The fastening means of the container 2 is adapted to engage the fastening means of the dosing assembly 4, which coupling may provide a permanent coupling such that the cartridge cannot be removed, thereby forming a pre-filled pen which can be discarded after the medicament in the cartridge has been emptied.

[0064] Alternatively, the fastening means of the container 2 and the fastening means of the dosing assembly 4 may form a releasable connection, which provides the possibility of reusing the dosing assembly with a new container after the previous empty container has been discarded.

[0065]According to the above-mentioned general transmission device concept,the latest state of the art syringe devices is marked by the applicant

4". The device provides a permanent dosing means adapted to receive a disposable cartridge which is easily replaceable by a user. For coupling a cartridge holder to

4 provides a simple, intuitive and reliable coupling. Figures 2 and 3 show the coupling of the cartridge holder and the dosing assembly in relation to4, detailed illustration of selected portions thereof. The syringe device 100 of fig. 2 and 3 includes a proximal portion 104 and a distal portion 102. In use, the proximal portion 104 forms part of a dosing assembly that includes a drive assembly (not shown) for expelling a small amount from the syringe device 100. The drive means of the proximal section 104 comprises a piston rod (not shown) extending along the central axis 106 in the cartridge receiving cavity 150 of the proximal section 104. In use, the distal portion 102 forms part of a container having a housing 102 for receiving a reservoir, such as a cartridge (not shown). In addition, the distal portion 102 may be adapted to support or attach a needle cannula assembly (not shown) at the distal end of the distal portion 102.

[0066] The distal portion 102 includes two male members or protrusions 110 disposed on each side of the distal portion 102. These protrusions 110 are used to secure the distal section 102 to the proximal section 104 by pushing the protrusions 110 into mating tracks forming the recesses 112 of the proximal section 104. The recess 112 is formed in a cartridge receiving cavity 150 on the inner surface of the proximal portion 104. The particular shape of each groove 112 is formed by the radial protrusion of adjacent ramp-like ridges 114 into cartridge receiving cavity 150. Each recess is formed by a first portion having an axially-entering opening for receiving the distal portion 102 such that the protrusion 110 enters the corresponding opening when the proximal and

distal portions

104, 102 are properly aligned. The opening of the groove 112 corresponds to a ramp gradually moving into the groove in the direction of the inner periphery, i.e. defined by the proximal counter surface 115. This arrangement provides a tightening movement between the distal and

proximal portions

102 and 104, including internal relative movement, followed by a combined axial and rotational movement, and finally ending with a single rotational movement.

[0067] Fig. 4a and 4b disclose cross-sectional views of a coupling part of a first embodiment of a medical delivery system according to the invention. Here, 200 denotes a medical delivery system comprising a container 202 (the distal end of which is omitted from the figure for simplicity), and a dosing assembly 204 (only certain parts relating to the distal end part are disclosed). The dosing device 204 comprises a first fastening means 212 forming a recess for receiving a male part or protrusion forming a second fastening means 210 provided on the container 202. The groove of the first fastening means 212 forms an opening into which the male part of the second fastening means 210 can be inserted when the container 202 is correctly aligned for axial entry into the cartridge receiving cavity 250. The container 202 may be secured to the dosing assembly by advancing the protrusion into the recess such that a distal facing surface 211 of the protrusion (second fastening means 210) engages a proximal facing surface 215 of the recess (first fastening means 212). Upon relative rotation between the dosing assembly 204 and the container 202, the dosing assembly 204 and the container 202 are drawn relative to each other due to the engagement between the distal opposing face 211 and the proximal opposing face 215. Due to the angle of the groove, the two parts can only be rotated relative to each other over a limited angle, i.e. less than one revolution.

[0068] In the illustrated embodiment, the number of different pairs of

fastening components

210 and 212 is selected to be two pairs. However, the number of different pairs of

fastening components

210 and 212 may be selected to be 1 to 6 pairs. Moreover, the peripheral distribution of the fastening components may be organized to be evenly distributed along the periphery, or may be non-uniform and asymmetric.

[0069] As with the injector device 100, the medical delivery system 200 may be adapted to couple the container 202 to the dosing assembly 204 by a fastening sequence involving an internal relative single axial movement, followed by a combined axial and rotational movement, and finally a single rotational movement. Alternatively, the fastening sequence may comprise a relative axial movement followed by a separate rotational movement, i.e. forming a conventional bayonet coupling.

[0070] Fig. 4a also shows two spring members 207, which will now be described in connection with fig. 4 b. The two spring members 207 are made of spring steel, which is bent or folded to form the hinge portion 205. The two spring members are fixed to the dosing assembly 204 in such a way that the ends of the spring members 207 protrude into the container receiving chamber 250, thereby forming a blocking member 206. Each blocking member 206 is moved from a first non-deflected position (the rest position shown in fig. 4 b) to a second deflected position (not shown) at which time the blocking member 206 is moved outwardly from the center of the container-receiving cavity 250. The blocking member is formed and arranged to substantially prevent any movement when a force is applied thereto from the distal end to the proximal end in the axial direction. In the particular embodiment shown, this is achieved by dimensioning the blocking member to be rigid and inflexible in the axial direction.

[0071] The number of barrier members in a particular medical delivery system may be selected to be 1 to 4 or more individual barrier members.

[0072] As shown in fig. 4b, the container 202 has an axial notch 220 extending in a distal direction from the proximal end of the container. Preferably, the number of axial notches 220 corresponds to the number of blocking members 206. The angular orientation of the axial notch 220 along the outer peripheral portion of the container 202 relative to the second fastening means 210 of the container 202 corresponds to the angular orientation of the blocking member 206 relative to the opening formed by the first fastening means 212. Thus, when the male member 210 of the container 202 is aligned with the opening of the recess 212 in the dosing assembly 204, the indentation 220 is aligned with the stop member 206.

[0073] The indentation 220 of the container 202 is adapted to receive the blocking member 206 when the container is axially inserted into the container receiving cavity of the dosing assembly 204. In the illustrated embodiment, the shape of the notch 220 or the peripheral dimension of the notch 220 is adapted to apply a force to the blocking member when the tightening movement begins an angular movement when the container is axially inserted into the container receiving cavity. The container thus exerts a force on the portion of the container wall adjacent to the one indentation, thereby moving the blocking member 207 radially outwardly from the first position in response to angular movement of the container 202 relative to the dosing assembly 204.

[0074] Fig. 4c illustrates a second variation of the first embodiment of the present invention wherein the medical delivery system 200' is adapted to handle a second medication that is different from the first medication handled by the medical delivery system 200. Here, the relative angular movement of the notch 220 ' with respect to the second fastening means 210 ' of the container 202 ' is different from that in the container 202. As with the medical delivery system 200, the orientation of the axial indentation 220 ' along the outer peripheral portion of the container 202 ' relative to the second fastening means 210 ' of the container 202 corresponds to the angular orientation of the barrier member 206 ' relative to the opening of the first fastening means 212 '. Thus, the container 202 ' can be fully axially inserted into the container receiving cavity 250 ' of the dosing assembly 204 ' and can be rotated as defined by this particular fastening movement.

[0075] In order to prevent confusion between different container medicaments and non-matching or not allowed dosing devices, each container 202, 202 ' having a specific distribution of coding features, such as second fastening means 210, 210 ' and indentations 220, 220 ', is assigned a specific coding feature depending on the medicament contained in each cartridge. Likewise, each dosing assembly 204, 204 ' has specific corresponding coding features such as first fastening assemblies 212, 212 ' and blocking members 206, 206 '.

[0076] To insert the container 202 ' into the container receiving cavity 205, the second fastening means 210 ' of the container 202 ' may be aligned with the opening formed in the first fastening means 212 of the dosing assembly 204. However, when this condition is met, the notch 220 'of the container 202' cannot be aligned with the stop member 206 of the dosing assembly 204. Since the blocking member 206 is able to resist axial forces from being displaced, the proximal rim portion of the container 202 ' will be blocked to allow the container 202 ' to axially enter the container receiving cavity 250, so that the user can easily determine that the container 202 ' is not of the correct type for coupling to the dosing assembly 204. The same applies if the user tries to insert the container 202 into the dosing assembly 204'. Similarly, the two devices 204 and 204' are designed to repel a cartridge holder without a notch. Also, by properly designing the containers 202 and 202 ', e.g. the second fastening means 210 and 210 ', it may be ensured that neither container 202 and 202 ' is compatible with a dosing assembly designed to receive a cartridge without a notch. This provides a one-to-one coding scheme that prevents drug confusion.

[0077] According to the invention it is ensured that the coding means of the container, such as the indentations 220, are designed as relatively narrow axially extending slits, so that a robust container can be provided, reducing the required area reserved for coding. Moreover, this design ensures that a large number of different codes can be obtained by providing a large number of possible angular positions for the coding elements defined by the notches 220.

[0078] As best shown in fig. 4a, the container-receiving cavity 250 forms an inner peripheral region 240, connecting each opening formed by the first fastening means 212. This area 240 provides a guiding surface for guiding the proximal end surface portion of the second fastening means 210 when a user attempts to bring the container 202 into internal rotational alignment with the dosing assembly 204.

[0079] The proximal face portion of the second fastening means 210 may be adapted to be spaced from the most proximal portion of the container by a distance X1. In some embodiments of the invention the distance X1 is reduced or, ultimately, the proximal face portion of the second fastening means defines the proximal end of the container. By positioning the blocking member 206 such that the distal portion of the blocking member 206 is more than the distance X1 away from the region 240 in the proximal direction, it is ensured that the blocking member 206 cannot be controlled by the most proximal portion of the container 202 when the user brings the container into the first initial angular alignment with the dosing assembly 204. At the same time, the distal portion of the blocking member 206 is preferably adapted such that the blocking member 206 blocks the axial entry of the wrong cartridge before the level reaches the level where the angular fastening movement is initiated as defined by the first and second fastening means. Thus, the indentations 220 of the correct container 202 are designed to be fully axially insertable into the container-receiving cavity 250. However, in considering these requirements, it is preferable that the distal end of the locking member 206 be adapted to be as close as possible to the above-mentioned distance X1.

[0080] Typically, if the axial length of the male member forming the second fastening means 210 is defined by the parameter t1, the total axial movement of the container from the entry point to the position of the first fastening means 212 (corresponding to the position of the region 240) and towards the fully inserted position is about twice or more of the parameter t 1.

[0081] When the distal portion of the barrier member is disposed adjacent region 240, the gap 220 preferably has a minimum length on the order of two times t 1. However, if the tightening movement process includes combined axial and rotational movement, the minimum gap length may be shorter. Typically, the axial length of the notch from the proximal end of the container 202 will be larger than t1, and finally, if the male part of the second fastening means is adapted at a distance from the proximal end of the container, the axial length of the notch will be longer. Typically, the notch length will be greater than the parameter t1, e.g. t1+ 30%, e.g. t1+ 50%, e.g. t1+ 100%, e.g. t1+ 200%, e.g. t1+ 300%.

[0082] Fig. 5 shows a medical delivery system 300 having a container 302 and a dosing assembly 304 according to a second embodiment of the invention. For the sake of simplicity, only the parts relating to the flexible coding means are included. The container 302 has a second fastening means and the dosing means has a corresponding first fastening means. However, these features are not included in the diagram shown in fig. 5. The container substantially corresponds to the container described in the first embodiment and thus has one or more indentations 320 to cooperate with the blocking member 306. In this embodiment, the blocking member 306 comprises a curved spring steel having two ends 308, each end fitting into a recess 309 of the dosing assembly 304.

[0083] When fitted into the dosing assembly 304, the member 306 forms a blocking member having a movable portion having a first non-deflected position (rest position, corresponding to the orientation shown in fig. 5) when a central portion of the blocking member 305 extends into the container-receiving chamber 350, and the movable portion is moved to a second deflected position (not shown) when the blocking member 306 is moved outwardly from the center of the container-receiving chamber 350. The blocking member 306 according to this embodiment performs a rotational movement from the first position to the second position substantially around an axis perpendicular to a first longitudinal axis passing through the center of the pen. The blocking member 306 and its mounting in the dosing assembly 304 are formed and arranged to substantially prevent any movement of the blocking member 306 when a force is applied thereon from the distal end to the proximal end in the axial direction. In the particular embodiment shown, this is achieved by sizing the blocking member 306 to be substantially rigid and inflexible in the direction of the pen axis. When a container 302 having a notch 320 cooperating with the blocking member 306 is inserted into the container receiving chamber 350 and the container 302 is rotated relative to the dosing assembly, the blocking member 306 or a part thereof is pushed outwards in a substantially radial direction if the side wall portion 321 of the container passes the blocking member during the rotation.

[0084] The movement of the blocking member 306 is limited by an additional, not shown, guiding surface, which prevents the central part of the blocking member 306 from moving in the proximal direction. This may be achieved by a not shown part of the dosing assembly being arranged inside the container receiving chamber 350. And the non-deflected position may be provided by forming the guide surface of the dosing assembly 304 to cooperate with the blocking member to urge the blocking member to its rest position.

[0085] Fig. 6a shows a third embodiment, which essentially corresponds to the concept shown in fig. 5. Also, the blocking member 406 may be made of a bent steel wire. In use, the wire has two free ends that can be fitted into grooves 409 extending in the axial direction of the pen. As shown in fig. 6b, 6c and 6d, the axial indentation 420 of the container 402 may be formed by a sloped or curved surface to facilitate engagement between adjacent sidewall portions 421 and the blocking member 406 when the sidewall portions 421 control outward movement of the blocking member 406.

[0086] The

indentations

220, 320, 420, 520 of the container may take many different forms according to various embodiments of the invention, all of which are also within the scope of the appended claims. Also, the indentations 420 may be formed as openings all extending radially outward from the central cavity of the container (which is adapted to receive the drive means of the dosing assembly 404) towards the outer peripheral wall surface of the container 402. Alternatively, depending on the specific design of the blocking member 406 and dosing assembly 404, the indentation may not extend completely from the inner cavity to the outer wall surface of the container, but may be formed as a recessed area in the wall, thereby forming an area with a smaller thickness in the vicinity of the wall.

[0087] Figures 7a-7e show different embodiments of a container and a dosing assembly with a blocking member 506 formed as an integral part of the container receiving portion of the dosing assembly, wherein the blocking member 506 forms a flexible portion allowing bending along a hinge portion formed by a hinge rotating along an axis extending parallel to the central axis of the pen. Alternatively, the entire barrier member portion may be deformed due to the resilient nature of the barrier member itself. In the embodiment shown, the flexible member has a spring member 507 attached for applying an inward force to the blocking member 506 in order to urge the blocking member 506 to its rest position, i.e. the central blocking member extends into the container receiving cavity.

[0088] Fig. 7b shows a similar construction to that shown in fig. 7a, but here two blocking members 506 arranged near the peripheral part of the container require two corresponding indentations 520 to be formed in the container for correct engagement. These requirements are met in the embodiment shown in fig. 7 b. Fig. 7c shows these components with the container fully inserted into the container receiving cavity, but prior to the locking, relative rotation has been performed.

[0089] Fig. 7e and 7d show specific details of the dosing assembly, more particularly the distal end face of the blocking member 506. To prevent the blocking member 506 from moving outwardly if the proximal rim portion of the container is accidentally rotated to contact the distal surface of the blocking member 506, the blocking member may have a groove 508 into which the rim portion of the container may be pressed. Alternatively, a protrusion 509 may be formed, which is adapted to be closer to the center of the cartridge than to the inner wall surface of the container. By means of these protrusions, the blocking member can be locked in its first (rest) position, so that only the correct container is received.

[0090] Fig. 8a and 8b show another embodiment, wherein a spring member 607 may be provided as a blocking member 606. Here, the shape of the spring member is such that the spring member 607 is correctly inserted and held in a recess formed in the dosing assembly. The inherent flexibility of the spring member 607 creates a first position where one end of the spring member 607 extends into the cartridge receiving cavity. When the container 602 with the matching notch 620 is rotationally aligned, the container 602 may be axially moved into the container receiving cavity 650 of the dosing assembly 604. This particular state is shown in fig. 8 b. The flexibility of the blocking member 606 causes the wall portion 621 to move past the blocking member 606 when the two portions are rotated relative to each other.

[0091] Other embodiments not shown include embodiments where the container portion of the medical delivery system has one or more flexible members forming the barrier member described above. In this configuration, the dosing assembly needs to be fitted with corresponding indentations to dispense the dosing assembly to each specific container.

[0092] Some preferred embodiments have been given above, 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 figures disclose the medical delivery system of the present invention in the form of an injection pen, however, the particular delivery device and its shape are by no means intended to limit the invention as defined in the claims.

Claims

1. A medical delivery system comprising:

- a container comprising a housing adapted to fill a cavity with a medicament and a piston arranged slidably movable in distal direction towards the discharge opening to reduce the volume of the cavity and pass the medicament through the discharge opening discharge;

- a dosing device having a container receiving chamber for at least partially receiving the container therein and coupling the container to the dosing device so that the drive means of the dosing device moves the piston of the container in the distal direction,

Wherein the dosing device defines first fastening means adapted to engage second fastening means of the container to secure the container to the dosing device, wherein the securing movement comprises relative movement along the first axis axial movement followed by relative rotational movement about the first axis;

Wherein, the batching device includes one or more blocking members, each blocking member can move from a first position to a second position, wherein in the first position, the blocking member radially extends to the In the container receiving cavity, the blocking member is moved radially outward in the second position, wherein the blocking member is movable from the first position to the second position in response to the relative rotational movement, while is prevented from moving from said first position to said second position when an axially external force is applied; and

Wherein the container includes a container wall portion formed with an axially extending notch for receiving said predetermined number of blocking members and enabling axial insertion of the container into said container receiving cavity.

2. The medical delivery system of claim 1, wherein the container defines a plurality of wall portions for defining the aperture, wherein at least one wall portion is adapted to move the blocking member radially outwardly when the container is rotated relative to the dosing device .

3. The medical delivery system as claimed in claim 1 or 2, wherein the blocking member is rotatably mounted relative to a rotational axis parallel to said first axis, or along a direction inclined relative to said rotational axis. The shaft is rotatably mounted.

4. The medical delivery system of claims 1-3, wherein the blocking member is a substantially inflexible flexible member when an axial force is applied to the blocking member, and wherein when rotating from the container relative to the dosing device Upon partial application of force, the blocking member is capable of bending in a radial direction.

5. A medical delivery system as claimed in any one of the preceding claims, wherein the position of said notch relative to said second fastening means is specific to the type of drug filled in said container.

6. A medical delivery system as claimed in any preceding claim, wherein the blocking member blocks entry of containers which are defined as impermissible, thereby preventing impermissible containers from participating in said relative rotational movement.

7. A medical delivery system as claimed in any preceding claim, wherein the second fastening means comprises at least one male cooperating member defined by a protrusion extending from the first shaft.

8. A medical delivery system as claimed in any preceding claim, wherein the second fastening means is provided at the proximal end of the container.

9. The medical delivery system of any one of claims 1-7, wherein the second fastening means is provided at the distal end of the container.

10. A medical delivery system as claimed in any preceding claim, wherein the number of said indentations formed in the container is 1, 2, 3, 4 or 5.

11. The medical delivery system of any one of claims 1-9, wherein the container includes a plurality of said indentations, wherein said indentations are irregularly distributed about said first axis.

12. A medical delivery system as claimed in any preceding claim, wherein the container housing includes a cartridge holder adapted to receive a cartridge.

13. A medical delivery system as claimed in any one of the preceding claims, wherein the stationary motion comprises purely axial relative motion along a first axis, followed by simultaneous relative axial and rotational motion, and then purely about the Rotational relative motion of the first axis described above.

14. A container for the medical delivery system of claims 1-13, the container comprising:

housing, adapted to be filled with medicament in the reservoir, having an open distal end sealed by a pierceable membrane and a slide-mounted stop adapted to be actuated by the drive means of the dosing device;

a proximal end having a second cavity adapted to receive the drive means of the dosing means;

a second fastening device releasably coupled to the first fastening device of the dosing device by a series of movements comprising relative axial movement along the first shaft followed by relative rotational movement about the first shaft;

Wherein the second fastening means comprises at least one male fitting part having a distal facing surface disposed at a first distance from the proximal end of the container, said distal facing surface being fixable to a corresponding corresponding portion of the dosing device. the proximal opposite side, and

Wherein the container comprises one or more indentations, wherein at least one indentation extends from the proximal end of the container in the distal direction by a distance greater than the first distance, the indentation forming a radial direction from the second cavity. An open area that extends outside the container.

15. A container as claimed in claim 14, wherein at least one of said male engagement features is formed by a radially extending protrusion provided at the proximalmost end of the container.

16. A container as claimed in claim 14 or 15, wherein at least one of said one or more notches extends from the proximal end of the container by a distance which exceeds said first distance by 50%, preferably 75% , more preferably 100%, more preferably 150%, more preferably 200%, most preferably 300%.

17. The container of claims 14-16, wherein the container includes a cartridge holder adapted to receive a cartridge, wherein the proximal end of the cartridge holder extends beyond the cartridge when the cartridge is inserted therein The proximal end of the cartridge holder is such that the one or more notches provide an opening extending radially outward from the second cavity to the exterior of the cartridge holder.