Abstract:
A needle magazine for storing and selectively dispensing a plurality of needle assemblies is comprised of a modules that are located adjacent each other and connected together side-by-side. The modules may be box shaped and provided on one side surface with a pin. A side opposite the side surface having the pin has a pin-receiving hole in which the pin of an adjacent module is secured. This allows an individual user to customize the capacity of the magazine based on the user&#39;s individual needs by joining as many or as few modules as needed. In some embodiments, a peg is used to secure the modules together. Each module may have a channel that accommodates the peg, thereby allowing a user to arrange the modules side-by-side and secure them with the peg. Also disclosed are methods for attaching needles stored in magazines directly non-symmetrical injection devices

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application claims the benefit of priority under 35 USC § 119 of U.S. Provisional Application Ser. No. 60/299,366 (filed on Jun. 19, 2001) and Danish Application PA 2001 00899 (filed on Jun. 11, 2001), both of which are hereby incorporated by reference in their entirety. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The invention relates to needle magazines for storing, dispensing and collecting a number of needle assemblies.  
           [0004]    2. Description of Related Art  
           [0005]    Medical injection devices are used to deliver selected doses of medication to patients. Some medication, such as insulin is self-administered. The typical diabetes patient will require injections of insulin several times during the course of the day. In order to prevent infections it is recommended to use a sterile needle assembly for each new injection. Needle assemblies are often delivered in a separate housing where such housing contains only one sterile needle assembly. Such a housing is shown in FIG. 1. The needle assembly and the housing together are hereafter referred to as a needle unit. Using a needle assembly of this kind requires the patient to open the housing and to fasten the needle assembly onto the injection device prior to each injection, as shown in FIG. 2. Usually the needle hub of the needle assembly is provided with an internal thread and force fitted into the housing. A typical injection device is provided with an external thread on its tip, which fits in the internal thread of the needle hub. In order to connect the needle assembly and the injection device these two elements must be rotated relatively to each other. In order to facilitate a better grip on the needle assembly, it is usually kept in the housing when mounting it on the injection device. After injection, the needle assembly is usually returned to the housing, and the complete needle unit is disposed of. The storage of sterile needle units of this type and the final disposal of used needle units present a problem, since new sterile needle units are often carried loosely in purses or briefcases, and used needle units are often disposed of unsafely.  
           [0006]    To overcome these problems a needle magazine for storage and dispensing a plurality of needle units has been developed. An example of such prior art magazine is shown in WO 00.54691, and comprises a plurality of needle units stored on a needle unit holding plate. The needle unit holding plate is provided with two opposite located grooves into which grooves the needle units slides. The needle units are covered by the needle unit holding plate, and must be separated from the needle unit holding plate prior to being mounted on the injection device.  
           [0007]    Another example of a prior art needle magazine is disclosed in WO 00.56379. This needle magazine comprises a needle storage case where the needle units are stored in a plurality of needle unit engaging holes, each storing one needle unit. The storage case is provided with a lid, which can slide to an open position in order to access the needle units. The housings of the needle units are rotationally locked to the needle storage case by a series of anti-rotation ribs located on each housing. These ribs interacts with a number of protruding ribs located on the side walls of the needle unit engaging holes.  
           [0008]    These needle magazines are delivered from the supplier in a predetermined size made to fit a specific number of needle units. The magazine disclosed in WO 00.56379 is made to fit 14 needle units, and in the magazine shown in WO 00.54691 each needle unit holding plate is made to store 7 needle units.  
           [0009]    People suffering from diabetes have different needs concerning the number of injections to be performed each day. The number of needle units a patient needs to carry around therefore differs from patient to patient. As a result of this, there is a great need for a needle magazine that can be custom built to facilitate the need of an individual patient.  
         SUMMARY OF THE INVENTION  
         [0010]    The magazine according to the one embodiment of the present invention is made from a number of individual modules, which are connected together to form a base member. Each individual module is provided with at least one needle engaging hole for storing a needle unit and connecting means for connecting together a number of individual modules. In this way each patient can build a needle magazine, which facilitates that individual patient&#39;s needs as far as the number of needle units is concerned.  
           [0011]    In some embodiments of the needle magazine according to the invention, each module is box shaped having an upper surface, including the needle unit engaging holes, a bottom surface, and four side surfaces located between the top and the bottom surface. Making the individual modules box-shaped gives the modules a similarity with ordinary building blocks (e.g. children&#39;s blocks), and the general idea of connecting such modules together is somewhat self-explanatory.  
           [0012]    In another embodiment of the needle magazine according to the invention each module comprises a longitudinal channel provided between opposite side surfaces. This allows a number of modules to be connected together side-by-side by mounting a peg in a longitudinal tunnel that is formed by the longitudinally aligning channels of neighboring modules. In this way the magazine can be connected by pushing or pulling a number of modules onto a peg, somewhat like pearls on a string. By obtaining a peg with sufficient length and the number of modules wanted, a custom build needle magazine containing a number of injection needles which facilitates the need of an individual patient is very easy build.  
           [0013]    When each module comprises a longitudinal channel provided between opposite side surfaces, a number of modules may be connected together side-by-side, by mounting a number of pins in the longitudinal tunnel formed by the longitudinal aligned channels of neighboring modules. In this embodiment of the present invention, a number of different pins can be utilized in connecting together the modules of a needle magazine according to the present invention.  
           [0014]    The pins used to connect the modules to each other can either be loose pins, or the pins can be moulded as an integrated part of each module.  
           [0015]    In most embodiments described herein, each module can be tilted such that the needle unit mounted in that specific module has free space around the needle unit. This has the advantage that the same needle magazine can accommodate a large variety of different injection devices including non-symmetrical injection devices (e.g., devices that are not symmetric about their needle mounting means) having an abutment, which abuts the skin during injection, such as the Innovo® and the InnoLet® from Novo Nordisk. And therefore provides a method for attaching needles directly to these injection devices from a magazine. The method comprises inserting a portion of the device into the magazine and rotating the device relative to the magazine.  
           [0016]    In addition each module can be provided with one or more raised portions on one of the side surfaces and similar depressions on the opposite side surface, such that a side surface carrying a raised portion will abut the side surface of the neighboring module having depressions when the needle magazine is connected. This will ensure that the modules are being properly indexed in relation to each other when the module in use is being tilted. The depressions would typically be located 90 degrees apart from each other.  
           [0017]    In some embodiments of the needle magazine according to the invention, the base member is provided with a lid covering the needle unit engaging holes form above, and which lid preferably slides in a number of grooves provided on two of the side surfaces located opposite each other. The presence of a lid makes it more hygienic to carry the needle magazine in a purse or a briefcase, and protects the barrier sheet from being damaged. Instead of a lid sliding in a number of groves, a lid that tips or twist can be used.  
           [0018]    In some embodiments of the present invention, each needle unit engaging hole is provided with at least one needle unit engaging element, such as ribs or depressions, for interfacing with a needle magazine engaging element, such as ribs or depressions, on the needle unit is located. This ensures that each of said needle units are non-rotatably stored in the needle unit engaging hole.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]    [0019]FIG. 1 Shows an exploded view of a needle unit that may be used with the present invention.  
         [0020]    [0020]FIG. 2 Shows a perspective view of an opened needle unit where the needle assembly is to be connected to an injection device.  
         [0021]    [0021]FIG. 3 Shows a view of a needle magazine according to an embodiment of the invention with the individual modules disconnected from each other.  
         [0022]    [0022]FIG. 4 Shows a view of a needle magazine according to an embodiment of the invention with the individual modules mounted on a peg.  
         [0023]    [0023]FIG. 5 Shows a view of a needle magazine according to an embodiment of the invention with the lid moved to a partly opened position.  
         [0024]    [0024]FIG. 6 Shows a view of a needle magazine according to an embodiment of the invention with one of the individual modules tilted. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0025]    [0025]FIG. 1 shows an exploded view of the prior art needle unit  1 . The needle unit  1  comprises a needle cannula  2 , which is mounted in a needle hub  3 . The needle cannula  2  has an injection part  4 , which enters the human body during injection, and a cartridge part  5  which enters a cartridge (not shown) contained in the injection device when the needle assembly is connected to an injection device  11 . The needle cannula  2  mounted in the needle hub  3  is referred to as the needle assembly. The injection part  4  of the needle cannula  2  is covered by a cover  6  in order to protect against accidental needle sticks.  
         [0026]    The needle assembly with the cover  6  mounted over the injection part  4  of the needle cannula  2  is finally mounted in a housing  7  having an opening covered by a sheet or foil  8  being impermeable to germs and the like, such that the interior of the housing  7  can be kept sterile. The sheet  8  has a flap  9 , which can be gripped by the fingers of a user in order to tear off the sheet prior to use. The entire unit is referred to as the needle unit  1 .  
         [0027]    [0027]FIG. 2 shows the needle unit  1  of FIG. 1 with the sheet  8  removed and an injection device  11  having a pencil-like shape being moved towards each other in order to connect the needle assembly onto the injection device  11 . Injection devices  11  are often provided with an external thread  12  located in the distal end of the injection device  11 , onto which thread  12  aninternal thread (not showns) located on the inside surface of the needle hub  3  are screwed when connecting the needle assembly onto the injection device  11 .  
         [0028]    A needle magazine according to one illustrative embodiment of the present invention is shown in FIG. 3. The needle magazine comprises a base member  19  made up from a number of individual box shaped modules  13 ,  14 ,  15 ,  16 ,  17 ,  18 . Each module  13 ,  14 ,  15 ,  16 ,  17 ,  18  has an upper surface  22  in which upper surface  22  a needle unit engaging hole  24  is provided. The needle unit engaging hole  24  is preferably provided with a number of outward pointing ribs  25  disposed approximately 90 degrees from each other. The housing  7  is provided with a number of depressions  10  which fits into the ribs  25  in order to prevent the housing  7  of the needle unit  1  from rotating relatively to the module  13 ,  14 ,  15 ,  16 ,  17 ,  18 . This coupling mechanism serves the purpose of preventing the needle units  1  from rotating when the needle assembly are being screwed onto the injection device  11 , and can as such be materialized in many different ways.  
         [0029]    The bottom surface of each module  13 ,  14 ,  15 ,  16 ,  17 ,  18  is located opposite the upper surface  22 , and the upper surface  22  and the bottom surface is connected by four side surfaces.  
         [0030]    As can be seen in FIG. 3 the box shaped modules  13 ,  14 ,  15 ,  16 ,  17 ,  18  are all identical and is provided with a pin  20  located on one of the side surfaces and a pin receiving hole  21  located on the opposite side surface. However the last module  18  needs not be provided with a pin  20 . It is evident that the opposite side surfaces can be provided with more than one pin  20  and more than one pin receiving hole  21  if so wanted. Each of the opposite side surfaces can even be provided with both a pin  20  and a pin receiving hole  21 .  
         [0031]    The base member  19  of the needle magazine can simply be made by connecting together a number of modules  13 ,  14 ,  15 ,  16 ,  17 ,  18  side-by-side, by entering the pin  20  of one module  13 ,  14 ,  15 ,  16 ,  17 ,  18  into the pin receiving hole  21  of the adjacent module  13 ,  14 ,  15 ,  16 ,  17 ,  18 . Each pin  20  is formed such that the pin  20  can secure each module  13 ,  14 ,  15 ,  16 ,  17 ,  18  to the neighboring module  13 ,  14 ,  15 ,  16 ,  17 ,  18 , e.g. by making the pin  20  from a soft or semi soft material, such as rubber, in order to increase the friction between the pin  20  and each individual module  13 ,  14 ,  15 ,  16 ,  17 ,  18 .  
         [0032]    Instead of moulding the pin  20  as an integrated part of the module  13 ,  14 ,  15 ,  16 ,  17 ,  18 , each module  13 ,  14 ,  15 ,  16 ,  17 ,  18  can be provided with a channel  26  extending all the way through the module  13 ,  14 ,  15 ,  16 ,  17 ,  18  from one side surface to the opposite side surface, as shown in FIG. 4. Together these channels  26  of neighboring modules  13 ,  14 ,  15 ,  16 ,  17 ,  18  form a longitudinal tunnel  27 .  
         [0033]    Each pin  20  could then be a loose pin  20 , which is inserted in the channel  26  e.g. by pressing half the length of the pin  20  into the channel  26 . The base member  19  of the needle magazine can also here be made by connecting together a number of modules  13 ,  14 ,  15 ,  16  side-by-side, by entering the pin  20  located in the channel  26  of one module  13 ,  14 ,  15 ,  16  into the channel  26  of the adjacent module  13 ,  14 ,  15 ,  16 ,  17 ,  18 .  
         [0034]    Instead of having one pin  20  entering into the channel  21  of each module  13 ,  14 ,  15 ,  16 ,  17 ,  18 , one long peg  28  can be entered into the longitudinal tunnel  27  formed by the longitudinal channels  26  of neighboring modules  13 ,  14 ,  15 ,  16 ,  17 ,  18 .  
         [0035]    The modules  13 ,  14 ,  15 ,  16 ,  17 ,  18  are preferably moulded from a semi-soft rubber since this provides friction to secure the needle housing  7  in the needle unit engaging hole  18  as well as friction to snap fit the pin  20  of each module  13 ,  14 ,  15 ,  16 ,  17 ,  18  into the pin receiving hole  21  of the neighboring module  13 ,  14 ,  15 ,  16 ,  17 ,  18 . Alternatively only the inside surface of each needle unit engaging hole  24  or each of the pins  20  can be moulded from a semi-soft rubber.  
         [0036]    The peg  28  could also be made from, or covered by, a soft or semi soft material, such as rubber, in order to increase the friction between the peg  28  and each individual module  13 ,  14 ,  15 ,  16 ,  17 ,  18 .  
         [0037]    [0037]FIG. 5 shows the complete needle magazine with the needle units  1  located in the needle unit engaging holes  24 . The base member  19  is covered by a lid  23  which slides in two grooves  29 ,  30  provided on opposite side surfaces of each module  13 ,  14 ,  15 ,  16 ,  17 ,  18 . The lid  23  can be transparent in order to allow the user to see how many needle units  1  are used and to protect the user from the cartridge part  5  of the needle cannulas  2 . The lid  23  is preferably made without any end surfaces such that the lid  23  can slide in both directions, but could be provided with one end surface such that the lid  23  only can slide in one direction.  
         [0038]    When connecting a needle assembly onto an injection device  11  having a pencil-like shape as the injection device  11  shown in FIG. 2, the sheet  8  are first removed by griping the flap  9  with the fingers and tearing off the sheet  8 . The thread  12  of the injection device  11  is then inserted into the not shown thread located on the inside surface of the needle hub  3 , and the injection device  11  is rotated relatively to the needle magazine screwing the needle assembly onto the injection device  11 .  
         [0039]    For self-administering insulin there are primarily two types of injection devices available today, both types having an external thread provided on the tip of the injection device for connecting with the internal thread of a needle assembly. One type of injection devices being a pencil-like shaped injection device, which is symmetrical around the axis of rotation used when mounting the needle assembly. The other type is a compact injector, or compact doser, which is an injection device with a non-symmetrical design. Both the Innovo® and the InnoLet® (e.g. shown in WO 98.10812) from Novo Nordisk are examples of such non-symmetrical injection devices. Since these so-called compact injectors are not symmetrical around the axis of rotation used when mounting the needle assembly, an ordinary needle magazine, as the one known from WO 00.56379 cannot accommodate such an injection device, while the injection device and the needle magazine can not be rotated relatively to each other because the injection device will abut the needle magazine.  
         [0040]    As shown in FIG. 6 each of the modules  13 ,  14 ,  15 ,  16 ,  17 ,  18  of the present needle magazine can be tilted. By tilting one module  13 ,  14 ,  15 ,  16 ,  17 ,  18  the needle unit  1  located in that specific module  13 ,  14 ,  15 ,  16 ,  17 ,  18  are brought into a position where the free space around the housing  7  of the needle unit  1  is sufficient to provide access for a so-called compact injector and to allow the needle assembly to be connected to such a non-symmetrical injection device by rotating the injection device relatively to the needle magazine. In order to gain more free space the pin  20  or the peg  28  and the pin receiving hole  21  or the channel  26  can be dislocated in relation to a center-line through the base member  12 . The free space around the needle unit  1  can be further increased by providing each module  13 ,  14 ,  15 ,  16 ,  17 ,  18  with a raised portion  31  (see e.g., FIG. 3).  
         [0041]    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.