Device for reconstituting a therapeutic solution, suspension or dispersion

Abstract

A packaging process inside a cylindrical reservoir ( 13 ) selected on one side by an injection piston ( 29 ) locked in its movement in said reservoir ( 13 ), comprising the elements to be packed ( 14 ) into the inside of said reservoir ( 13 ) from said injection piston ( 29 ) before said reservoir ( 13 ) is sealed by said piston ( 29 ), said reservoir ( 13 ) being tube or a cartridge ( 13 ) sealed beforehand from the other side and introducing the cylindrical reservoir ( 13 ) beforehand into a support ( 19 ) and said piston ( 29 ) locked in another support ( 19 ), thus allowing an opening to the outside of said reservoir between the two supports ( 19 ); introducing the piston ( 29 ) into said reservoir ( 13 ) by pressure and by a bringing together of said two supports ( 19 ).

1 - 10 . (cancelled)  
   
   
       11 . A packaging process inside a cylindrical reservoir ( 13 ) sealed on one side by an injection piston ( 29 ) locked in its movement in said reservoir ( 13 ), comprising the elements to be packed ( 14 ) into the inside of said reservoir ( 13 ) from said injection piston ( 29 ) before said reservoir ( 13 ) is sealed by said piston ( 29 ), said reservoir ( 13 ) being tube or a cartridge ( 13 ) sealed beforehand from the other side and introducing the cylindrical reservoir ( 13 ) beforehand into a support ( 19 ) and said piston ( 29 ) locked in another support ( 19 ), thus allowing an opening to the outside of said reservoir between the two supports ( 19 ); and introducing the piston ( 29 ) into said reservoir ( 13 ) by pressure and by a bringing together of said two supports ( 19 ).  
   
   
       12 . The process of  claim 11 , wherein a lyophilization is carried out before sealing by said injection piston ( 29 ).  
   
   
       13 . The process of  claim 12 , wherein the piston ( 29 ) is definitely positioned in the reservoir ( 13 ) by the ambient pressure, thus allowing a packaging control.  
   
   
       14 . The process of  claim 12  wherein the packaging elements ( 14 ) are introduced and frozen separately in layers in the reservoir ( 13 ) before lyophilization.  
   
   
       15 . The process of  claim 11  wherein the cylindrical reservoir is introduced beforehand into a support ( 19 ) on which said piston ( 29 ) is positioned beforehand, thus allowing an opening to the outside of said reservoir ( 13 ) through said support ( 19 ); and introducing the piston ( 29 ) is then introduced into said reservoir ( 13 ) by pressure and by displacement in said support ( 19 ) which serves to guide it.  
   
   
       16 . The process of  claim 12  wherein the supports ( 19 ) constitute a part of the injection syringe device and of its package.  
   
   
       17 . The process of  claim 11  wherein the elements to be packed ( 14 ) are a mixture stirred beforehand in a very vigorous manner in the reservoir.  
   
   
       18 . The process of  claim 11  wherein the cylindrical reservoir is introduced beforehand into a support ( 19 ) and the piston ( 29 ) locked in another support ( 19 ), thus allowing an opening to the outside of said reservoir between the two supports ( 19 ), said piston then being introduced into said reservoir by pressure and by a bringing together of the two supports ( 19 ).  
   
   
       19 . The process of  claim 18 , wherein the supports ( 19 ) are moreover hermetically closed after bringing together and constituting the package of said cylindrical reservoir ( 13 ).  
   
   
       20 . A syringe type device actuated by a piston and intended to reconstitute a preparation, in solution, in suspension or in dispersion in a liquid, comprising: 
 a cartridge constituting the proximal reservoir ( 13 ) containing the non-liquid part ( 14 ) of the preparation, said cartridge ( 13 ) forming part of the body of said syringe and being sealed at one end by a fixed element ( 27 ) and at the other end by a piston ( 29 );    a cartridge constituting a distal reservoir ( 11 ) containing liquid part ( 12 ) of the preparation, said cartridge forming an injection rod of the piston of the syringe;    a hollow transfer element ( 18 ) located between the two cartridges ( 11 ,  13 ); and    an injection needle ( 20 );    wherein these elements are all arranged inside a plastic body and there is no physical link between the two said reservoirs ( 11 ,  13 ),    said device being characterized in that: 
 a) said cartridge constituting the proximal reservoir ( 13 ) containing the non-liquid part ( 14 ) of the preparation is under vacuum;  
 b) said cartridge constituting the proximal reservoir ( 13 ) is directly in contact with the outlet of the injection needle ( 20 );  
 c) said piston ( 29 ) is prevented from being pushed in by a locking mechanism ( 16 ) on said reservoir ( 13 ), said locking mechanism ( 16 ) being able to be deactivated;  
 d) said cartridges being designed so that the cartridge constituting the distal reservoir ( 11 ) containing the liquid part ( 12 ) can penetrate into the interior of the body of the syringe, and, provided the locking mechanism ( 16 ) is unlocked, into the interior of the cartridge constituting the proximal reservoir ( 13 ) containing the non-liquid part ( 14 ) of the preparation; and  
 e) the device includes a mechanism by which, after entry into said piston ( 29 ), said hollow transfer element ( 18 ) is withdrawn before the injection and the tightness of the cartridge constituting the proximal reservoir ( 13 ) is thereby restored.