Abstract:
Described is a medicament delivery device comprising a body adapted to accommodate a cartridge containing a medicament, and a reservoir coupled to the body, the reservoir containing a fluid and a plunger. The cartridge is axially movable relative to the body between a retracted position and an extended position. Axial movement of the cartridge from the retracted  10  position to the extended position moves the plunger to expel the fluid from the reservoir.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2012/068231 filed Sep. 17, 2012, which claims priority to European Patent Application No. 11184412.2 filed Oct. 7, 2011. The entire disclosure contents of these applications are herewith incorporated by reference into the present application. 
     
    
     FIELD OF INVENTION 
       [0002]    It is an object of the present invention to provide an apparatus for intraocular injection allowing to clean, disinfect and/or sterilize at least an injection site for an intraocular injection. 
       BACKGROUND 
       [0003]    A number of vision-threatening disorders or diseases of the eye need to deliver a medicament (drug or proteins or the like) to a posterior segment of the eye by intraocular delivery (more specifically intravitreal delivery), especially when it is useful to deliver high concentrations of medicament. One such technique for intraocular delivery is accomplished by intraocular injection of the medicament or capsules containing the medicament directly into the vitreous body or by locating a device or capsule containing the medicament in the vitreous with a syringe. Such an operation is used in particular for injection of compositions into the vitreous body of the eye in order to treat diseases affecting retina or choroid, or ciliary body or the lens. 
         [0004]    After delivery of medicament to the interior, such as the vitreous body, of the eye it is desirable that the point of entry of any medicament delivery closes and heals or seals as quickly and completely as possible after withdrawal of the medicament delivery device or syringe. This sealing is important for the following reasons. This sealing prevents reflux of the delivered medicament. Further, the effects of the operation on the internal eye pressure are reduced. Additionally, sealing assists with the healing of the eye tissue affected generally (e.g. sclera) and therefore prevents infections and other complications. Thus, the risk of infection is reduced. 
         [0005]    When carrying out invasive procedures on the eye, e.g. administering medicaments into the vitreous body, it is essential that the surrounding area is rinsed and properly cleaned and disinfected. The current practice is to irrigate with saline and then disinfect with iodine solution. This involves a number of steps and thus there is a need for improvements. 
         [0006]    An additional potential problem with the conjunctival displacement technique is that it is difficult to verify visually that the conjunctiva has, in fact, been displaced prior to administering the injection. This is due to the fact that the conjunctiva is translucent and extremely thin, perhaps only two to four cells thick. 
       SUMMARY 
       [0007]    In an exemplary embodiment, a medicament delivery device according to the present invention comprises a body adapted to accommodate a cartridge containing a medicament, and a reservoir coupled to the body, the reservoir containing a fluid and a plunger. The cartridge is axially movable relative to the body between a retracted position and an extended position. Axial movement of the cartridge from the retracted position to the extended position moves the plunger to expel the fluid from the reservoir. 
         [0008]    In an exemplary embodiment, the delivery device further comprises a needle coupled to the cartridge. In the retracted position, the needle is contained within the body, and in the extended position, the needle is exposed from the body. The needle passes through the reservoir when moving from the retracted position to the extended position. 
         [0009]    In an exemplary embodiment, the plunger is coupled to the cartridge. 
         [0010]    In an exemplary embodiment, the reservoir includes a foot portion adapted to be placed on an eye. The foot portion has a contour to fit a shape of the eye. 
         [0011]    In an exemplary embodiment, the reservoir includes an opening having at least one channel. The channel creates a flow path for the fluid from the reservoir to an exterior of the reservoir. The opening is covered by a cover. 
         [0012]    In an exemplary embodiment, the fluid includes at least one of a disinfectant, a solution to promote healing, an analgesic, an antibiotic, a medicament, a marker and an antimicrobial. 
         [0013]    In an exemplary embodiment, the delivery device further comprises a ring adapted to align the delivery device on the eye. 
         [0014]    In an exemplary embodiment, the delivery device further comprises a finger adapted to displace a conjunctival layer of the eye relative to a sclera layer when the cartridge is moving from the refracted position to the extended position. 
         [0015]    The person skilled in the art understands that the present invention is not restricted to the explained possibilities. 
         [0016]    The above mentioned advantages as well as other advantages of various aspects of the present invention will become apparent to those of ordinary skill in the art by reading the following detailed description, with appropriate reference to the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    Exemplary embodiments of the present invention are described herein with reference to the schematic drawings in which: 
           [0018]      FIG. 1  shows a sectional view of an exemplary embodiment of a medicament delivery device according to the invention in a retracted position, 
           [0019]      FIG. 2  shows a sectional view of an exemplary embodiment of a medicament delivery device according to the invention in an advanced position, 
           [0020]      FIG. 3  shows an enlarged sectional view of a distal end of an exemplary embodiment of a medicament delivery device according to the invention, 
           [0021]      FIG. 4  shows a view on a distal end of an exemplary embodiment of a medicament delivery device according to the invention, 
           [0022]      FIG. 5  shows a sectional view of another exemplary embodiment of a medicament delivery device according to the invention in a retracted position, 
           [0023]      FIG. 6  shows a further sectional view another exemplary embodiment of a medicament delivery device according to the invention, 
           [0024]      FIG. 7  shows a further sectional view of another exemplary embodiment of a medicament delivery device according to the invention in an advanced position, 
           [0025]      FIG. 8  shows a sectional view of yet another exemplary embodiment of a medicament delivery device according to the invention in a retracted position, 
           [0026]      FIG. 9  shows a further sectional view of yet another exemplary embodiment of a medicament delivery device according to the invention, 
           [0027]      FIG. 10  shows a further sectional view of yet another yet another exemplary embodiment of a medicament delivery device according to the invention, and 
           [0028]      FIG. 11  shows an isometric view of exemplary embodiments of a medicament delivery device and a separate dispensing tube according to the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0029]      FIGS. 1 to 4  show exemplary embodiments of a medicament delivery device for an intraocular injection according to the invention. The delivery device has a generally cylindrical outer body or housing  1  which defines a hollow internal space for receiving a cartridge  2  containing at least one medicament  3 . Examples of such a medicament are steroids or monoclonal antibodies used to treat macular degeneration, pharmaceuticals, implantable devices, etc. As shown in  FIGS. 1 and 2 , the cartridge  2  may have a configuration similar to that of a conventional syringe, e.g., with a plunger  4  acting on a syringe piston  5  to expel the medicament  3  through a needle  6  located at a distal end syringe. 
         [0030]    In an exemplary embodiment, the cartridge  2  is received within the body  1  and is axially translatable relative to the body  1 . In other words, the cartridge  2  may be moved relative to the body  1  as shown in a retracted position in  FIG. 1  in which the needle  6  is not exposed (e.g., pre- and post-injection) and an extended position in  FIG. 2  in which the needle  6  is exposed (e.g., during an injection). Such a relative displacement may either be achieved by advancing the cartridge  2  within the body  1  or by retracting the body  1  relative to the cartridge  2 . 
         [0031]    Further, a reservoir  7  is coupled to a distal portion of the body  1 . A piston  8  is axially moveable within the reservoir  7  in a sealed manner. As shown in  FIG. 4 , a distal part of the reservoir  7  is provided with a discharge opening  9  which is located in a foot portion  10  of the body  1 . The foot portion  10  is designed to be placed on the outer surface of an eye  11 . For example, the foot portion  10  may be contoured (e.g., circular, semi-circular, etc.) to fit the outer surface of the eye  11 . As shown in more detail in  FIGS. 3 and 4 , the discharge opening  9  may be in the form of a series of channels  12  which create a flow path for contents of the reservoir  7 . 
         [0032]    In an exemplary embodiment, the reservoir  7  is prefilled with a fluid  13 , e.g., a disinfectant, an antimicrobial, a solution to promote healing, etc. For example, the fluid  13  may be a cleaning and/or sterilizing agent to rinse and clean an injection site on the eye  11  prior to an injection. In addition or as an alternative, the fluid  13  may be a marker fluid, preferably a low viscosity gel which contains a dye or granular pigmentation. This allows marking the injection site such that a visual verification of a movement of the conjunctiva relative to the sclera of the eye  11  is allowed. Further, the fluid  13  or gel may be colored so that the presence and location of the fluid  13  on the eye can be observed. 
         [0033]    In the exemplary embodiment shown in  FIGS. 1 and 2 , the piston  8  has a distal part which is guided within the reservoir  7  and a proximal part which may be located within the body  1 . When a force is applied to the proximal part, the distal part of the piston  8  serves to expel fluid  13  from the reservoir  7 . In an exemplary embodiment, the proximal part serves to mechanically slave the piston  8  to the cartridge  2  or another part of the body  1  (e.g., a cartridge carrier) such that the movement of piston  8  is at least partially synchronized with the movement of the cartridge  2  relative to the body  1 . In an exemplary embodiment, the movement of the piston  8  is such that the fluid  13  is dispensed on to the surface of the eye  11  after activation of whichever mechanism is used to displace the conjunctiva of the eye  11 . In an exemplary embodiment, the reservoir  7  may be telescopically formed on the body  1 , and the piston  8  may be an annular member disposed within the reservoir  7  and the body  1 . 
         [0034]    In use, the exemplary embodiment of the delivery device is placed on the eye  11  as shown in  FIG. 1  with the foot portion  10  located surrounding an injection site. The cartridge  2  with its needle  6  is then moved relative to the body  1  from the retracted position shown in  FIG. 1  into the extended position shown in  FIG. 2 . As the movement of the cartridge  2  relative to the body  1  pushes the piston  8  in the distal direction within the reservoir  7 , the fluid  13  is expelled through the channels  12  in the foot portion  10 . In an exemplary embodiment, the channels  12  are arranged so that the fluid  13  is directed onto the surface of the eye  11  to both sides of the injection site and then across the injection site in the form of a continuous blanket. This may allow sweeping any debris or foreign bodies from the injection site. As an alternative to the embodiment shown in  FIGS. 1 to 4 , the shaped channel and foot portion may be designed to direct the fluid  13  into the surface of the eye  11  to one side only of the puncture site and then across the puncture site in the form of a continuous blanket. 
         [0035]    Another exemplary embodiment of the invention is shown in  FIGS. 5 to 7  wherein  FIGS. 5 and 6  show a medicament delivery device with a needle in a retracted position whilst  FIG. 7  shows the medicament delivery device with the needle in an extended position. The general design of the medicament delivery device is similar to that described above with respect to  FIGS. 1 to 4 , i.e. the reservoir  7  is coupled to the body  1 , and the body  1  is adapted to receive the cartridge  2  and the needle  6 . In this exemplary embodiment, the delivery device includes a ring  14  for positioning the delivery device on the eye  11 . Further a finger  15  is provided for displacing the conjunctiva with respect to the sclera prior to the needle  6  piercing the eye  11 . Channels  12  are provided which lead from the reservoir  7  to orifices in the region of the finger  15 . The use of this exemplary embodiment of the delivery device is similar to that described above. 
         [0036]      FIGS. 8 to 10  show a further exemplary embodiment of the present invention, wherein a reservoir  17  is coupled to the distal end of the delivery device, and a distal end of the cartridge  2 , including the needle  6 , is disposed in the reservoir  17 . A piston  18  is provided in the reservoir  17  to expel fluid  13  from reservoir  17  through a distal opening  19 . In an exemplary embodiment, the piston  18  has a generally annular form and engages the distal end of the cartridge  2 . Thus, the piston  18  is moved in unison with the cartridge  2  if the latter is displaced in the distal direction relative to the body  1 . 
         [0037]    As can be seen in  FIG. 8 , the opening  19  may be sealed with a cover  20  or similar thereby coincidentally sealing off the needle  6  and the fluid  13 . The cover  20  may be removed prior to use as shown in  FIG. 9 . In use of the delivery device, the cartridge  2  is move distally relative to the body  1 , and the fluid  13  is expelled from the reservoir  17  by the plunger  18 . The fluid  13  covers the puncture site before, during and after the injection process. This is shown in  FIG. 10 . The fluid  13  preferably has a viscosity great enough to remain in place upon and around the puncture site during and after the injection. 
         [0038]    An alternative embodiment is shown in  FIG. 11 , a dispensing tube  21  may be used to apply e.g. a marker gel, prior to activation of the medicament delivery device. 
         [0039]    Those of skill in the art will understand that modifications (additions and/or removals) of various components of the apparatuses, methods and/or systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.