Method for Making a Reservoir Containing an Active Substance Diffused through the Reservoir and Installation Therefor

Abstract

The invention concerns a method for making a reservoir ( 5 ) containing an active substance and adapted to be introduced into a natural cavity of a living being, the reservoir ( 5 ) comprising a membrane ( 9 ) permeable to the active substance. Said method includes steps which consist in: a) placing at least one tube designed to constitute the membrane ( 9 ) in at least one retaining member, the ends of the tube being open; b) injecting through at least one of the tube ends, while expelling any residual air present in the tube, an amount of a product ( 8 ) containing an active substance in pasty form, said amount corresponding substantially to an inner free volume of the tube; c) when the tube is full, closing the end of the tube opposite the end from which the injection is performed; d) proceeding with the injection of the product ( 8 ) in pasty form into the free volume until achieving the outer desired diameter (D 5 ) for the reservoir ( 5 ) by allowing the radial expansion of the tube; e) polymerizing the product ( 8 ) when the reservoir ( 5 ) reaches the desired outer diameter (D 5 ) while maintaining the reservoir ( 6 ) in the retaining member. The method is particularly designed for producing hormonal intrauterine contraceptive devices.

1 . A method of making a reservoir ( 5 ) containing an active substance and suitable for being inserted into a natural cavity of a living being, said reservoir ( 5 ) comprising a membrane ( 9 ) that is permeable to said active substance, characterized in that it comprises: 
 a) placing at least one tube ( 10 ) designed to form said membrane in at least one retention member ( 11 ;  22 ), the ends of said tube being open,    b) injecting ( 16 ) through one of said ends of said tube ( 10 ), while expelling all the residual air present in said tube, a quantity of product ( 8 ) containing an active substance in paste form, this quantity corresponding substantially to the internal free volume ( 20 ) of said tube ( 10 ),    c) when said tube ( 10 ) is full, closing the end ( 24 ) of the tube opposite to the end from which the injection ( 16 ) is performed,    d) continuing the injection ( 16 ) of said product ( 8 ) in paste form into said free volume ( 20 ) until the desired external diameter (D 5 ) for said reservoir ( 5 ) is obtained by allowing said tube to expand radially (F 5 , F′ 5 ),    e) polymerizing said product ( 8 ) when the reservoir ( 5 ) has the desired external diameter (D 5 ) while keeping the reservoir ( 5 ) in the retention member ( 11 ;  22 ).    
     
     
         2 . The method as claimed in  claim 1 , characterized in that, after step e), the reservoir ( 5 ) is cut to the desired final length.  
     
     
         3 . The method as claimed in  claim 1 , characterized in that, during step a), a rod ( 13 ) is inserted into the internal volume ( 20 ) of said tube ( 10 ).  
     
     
         4 . The method as claimed in  claim 1 , characterized in that, during step a), several tubes ( 10 ) are simultaneously placed in at least one retention member.  
     
     
         5 . The method as claimed in  claim 4 , characterized in that steps b) to e) are carried out simultaneously on all the tubes ( 10 ) placed in at least one retention member.  
     
     
         6 . A method for making a reservoir ( 5 ) containing an active substance and suitable for being inserted into a natural cavity of a living being, said reservoir being enveloped by a membrane ( 9 ) permeable to said active substance, characterized in that it comprises: 
 at least one member ( 11 ; 22 ) for the retention of at least one tube ( 10 ) designed to form said membrane ( 9 ), said retention member comprising at least one mold ( 11 ; 22 ) defining a housing ( 12 ; 25 ) for receiving said tube ( 10 ) when it is filled and when said product  8  is polymerized;    at least one member ( 16 ,  17 ,  18 ) for the injection of a product ( 8 ) containing the active substance into said tube;    at least one member ( 14 ,  13 ;  31 ) for the closure of at least one end ( 21 ) of said tube after it has been filled with the product.    
     
     
         7 . The installation as claimed in  claim 6 , characterized in that the closure member comprises a rod ( 13 ) and a plate ( 14 ) for blanking off one end ( 21 ) of the tube ( 10 ) and one end ( 12 B) of the housing ( 12 ).  
     
     
         8 . The installation as claimed in  claim 6 , characterized in that said retention member ( 11 ) is fitted, on an internal face ( 11 A), with coupling points of the wall ( 9 ) of the tube ( 10 ) suitable for preventing the retraction and/or the longitudinal extension of said wall ( 9 ) when the product ( 8 ) is injected and/or polymerized.  
     
     
         9 . The installation as claimed in  claim 7 , characterized in that the rod ( 13 ) is covered with a material not adhering to the rod ( 13 ), particularly a sheath ( 130 ).  
     
     
         10 . The installation as claimed in  claim 6 , characterized in that said housing ( 25 ) comprises at least one zone ( 26 ) for receiving at least one member ( 34 ,  35 ) for positioning the ends of the tube ( 10 ).  
     
     
         11 . The installation as claimed in  claim 10 , characterized in that the housing ( 25 ) comprises at least two reception zones ( 26 ), each being placed in the vicinity of an end of the housing ( 25 ) and suitable for receiving a positioning member ( 34 ,  35 ).  
     
     
         12 . The installation as claimed in  claim 11 , characterized in that said members are rings ( 34 ) furnished with a radial collar ( 35 ).  
     
     
         13 . The installation as claimed in  claim 12 , characterized in that said rings ( 34 ) have an internal diameter (D 34 ) close to the external diameter (D 5 ) desired for the reservoir ( 5 ).  
     
     
         14 . (canceled)