Patent Publication Number: US-2004044327-A1

Title: Transfer needle assembly

Description:
FIELD OF THE INVENTION  
       [0001] The present invention relates to a transfer needle assembly for transferring fluid from a fluid source to a vial containing a solid material or a liquid material. The transfer needle assembly of the present invention eliminates problems such as contamination of a tip of a puncture needle in the transfer needle assembly before use and injury to an operator&#39;s finger by the tip of the puncture needle and fluid leakage from the transfer needle assembly when in use.  
       BACKGROUND OF THE INVENTION  
       [0002] In order to prepare a liquid medical component for adhering tissues in a living body or to be mixed with a solid component at a medical facility, or to be injected by a patient himself for home medical treatment, a dried or liquid medicine contained in a vial is dissolved with a fluid such as saline to make a medicinal solution which is then transferred to a syringe. A syringe with a puncture needle or a tool having two hollow puncture needles at both ends, called a “double-ended needle”, has been used for these operations. When the syringe with a needle is used, a rubber stopper in a mouth portion of a fluid container is pricked with the puncture needle to collect a predetermined amount of the fluid into the syringe and then, a rubber stopper in a mouth portion of a vial is pricked with the same needle to inject the fluid into the vial from the syringe. Then, the vial is shaken to dissolve the medicine with the fluid and the rubber stopper is pricked with the above needle again to collect a predetermined amount of the medicinal solution into the syringe. When the “double-ended needle” is used, the rubber stopper of the vial filled with a dried medicine is pricked with one puncture needle of the double-ended needle and the rubber stopper of the fluid container is pricked with another puncture needle, respectively, which are located at both ends of the double-ended needle to communicate the vial with the fluid container. The fluid in the fluid container is transferred to the vial to dissolve the dried medicine, then, the fluid container and the double-ended needle are removed from the vial, and finally, the rubber stopper of the vial is pricked with a syringe with a needle likewise to collect a predetermined amount of the medicinal solution into the syringe.  
       [0003] These prior techniques involve a problem in that when the procedure of dissolving a dried medicine is carried out using the syringe with a needle, the procedure is complicated, the tip of the puncture needle may be contaminated before use because the needle is exposed, and an operator may get injured by the tip of the needle when in use. When the double-ended needle is used and the needle is pulled out or a predetermined amount of the medicinal solution is collected into the syringe, the operator may get injured by the tips of the needle, and the tips of the needle may be contaminated before the collection of the medicinal solution because the tips of the needle are exposed like the syringe with a needle. To solve the above problems, there is proposed an admixture injection adaptor which enables both injection and collection of a medicinal solution during a dissolution procedure (refer to JP 7-213585 A, paragraphs [0008] to [0012], FIG. 1 and FIG. 2)  
       [0004] In the admixture injection adaptor in this reference, a hollow puncture needle and a tubular tip fitting part, respectively, are set on opposite sides on the axis of a discoid hub, and a tubular vial fitting part which is concentrically extended over the tip of the puncture needle and a tubular syringe fitting part which is concentrically extended over the tip of the tip fitting part are constructed on the outer edge of the hub. The adaptor can conveniently transfer a medicinal solution in a vial to a syringe after medicine in the vial is dissolved with a fluid to prepare the medicinal solution while contamination of the tip of the needle or injury by the needle is avoided. However, the length of the skirt is limited so as to prevent the end of the skirt from contacting with the shoulder of the vial when the vial is pricked with the needle, whereby the vial cannot be fitted straight and, therefore, a gap is formed between the rubber stopper of the vial and the needle to cause leakage of the medicinal solution during dissolution.  
       SUMMARY OF THE INVENTION  
       [0005] The present invention has been made in view of the above circumstances, and it is, therefore, an object of the present invention to provide a transfer needle assembly having the following advantages: the dried medicine can be easily dissolved; contamination of the tip of the needle and injury of an operator by the tip of the needle can be avoided; and leakage of a fluid from the transfer needle assembly during dissolution can be prevented.  
       [0006] In order to solve the above problems, the inventor of the present invention has carried out extensive studies. The inventor understood that it would be desirable that the tip of the puncture member be capable of sliding from a position where the tip is receded in a skirt portion to a position where the tip projects from the skirt portion during transferring and injecting of a fluid, thereby reaching the present invention. Namely, the present invention relates to a transfer needle assembly comprising;  
       [0007] a cap-like guide member  1  having a top surface  11 , a skirt portion  13  and a tubular puncture needle insertion portion  12  penetrated through the top surface  11  in the axial direction of the cap-like guide member  1 ; and  
       [0008] a puncture member  2  comprising a tubular member provided with a tip fitting portion  21  at the proximal end thereof for fitting a tip of a syringe and a puncture needle  22  at the distal end thereof to be inserted into the puncture needle insertion portion  12  of the cap-like guide member  1 , and a filter portion  23 ;  
       [0009] wherein the puncture needle  22  has a needle tip  223  and is provided with a gas passage  221  and a liquid passage  222 ; and the liquid passage  222  communicates with the tip fitting portion  21  and the gas passage  221  is open to the outside through an air filter  231  in the filter portion  23 , and  
       [0010] wherein the puncture member  2  is fitted in the puncture needle insertion portion  12  of the cap-like guide member  1  in such a manner that the needle tip  223  of the puncture needle  22  in the puncture member  2  slides from a position where the needle tip  223  is receded in the skirt portion  13  to a position where the needle tip  223  projects from the skirt portion  13 .  
       [0011] Here, it is desirable that a cutout  14  is formed in the skirt portion  13  of the guide member  1  so that the puncture needle  22  which recedes into the skirt portion  13  can be seen. A disk-like, preferably sector disk-like collar  24  may also be provided at the proximal end of the puncture needle  22  to stop sliding in a forward direction of the puncture member  2  when the collar  24  comes in contact with the proximal end  122  of the puncture needle insertion portion  12 . It is also desirable that the inner wall of the puncture needle insertion portion  12  is undercut to form a stepped portion  121  while retaining the proximal end portion thereof, an intermediate portion of the puncture needle  22  is provided with an annular projection  224 , and the stepped portion  121  formed by undercutting engages with the annular projection  224  to stop sliding of the puncture member  2  in a backward direction.  
       [0012] Slide suppression means  32  for preventing accidental sliding of the puncture member  2  may also be provided between the collar  24  of the puncture member  2  and the top surface  11  of the guide member  1 . The slide suppression means is suitably a spring or a prop. 
     
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
     [0013]FIG. 1 is a front view of an embodiment of the present invention.  
     [0014]FIG. 2 is a sectional view cut on line X-X of FIG. 1.  
     [0015]FIG. 3 is a longitudinal sectional view of another embodiment of the present invention.  
     [0016]FIG. 4 is a front view of still another embodiment of the present invention.  
     [0017]FIG. 5 is a front sectional view of FIG. 4.  
     [0018]FIG. 6 is a sectional view cut on line Y-Y of FIG. 4.  
     [0019]FIG. 7 is a diagram for explaining use of the transfer needle assembly of the present invention.  
     [0020]FIG. 8 is a diagram for explaining use of the transfer needle assembly of the present invention. 
    
    
     THE MOST PREFERRED EMBODIMENT OF THE INVENTION  
     [0021] Preferred embodiments of the present invention will be described with reference to the accompanying drawings.  
     [0022] As shown in FIGS.  1  to  6 , the transfer needle assembly of the present invention includes a cap-like guide member  1  having a top surface  11 , a skirt portion  13  and a puncture needle insertion portion  12 ; and a puncture member  2  fitted in the puncture needle insertion portion  12  of the cap-like guide member  1  in such a manner that a needle tip  223  of a puncture needle  22  in the puncture member  2  slides from a position where the needle tip  223  is receded into the skirt portion  13  to a position where the needle tip  223  projects from the skirt portion  13 .  
     [0023] The guide member  1  is generally a cap-like member formed from a plastic such as polypropylene, polyethylene, polyester, polyvinyl chloride, polycarbonate or ABS resin and has the top surface  11 , the skirt portion  13  and the tubular insertion portion  12  for puncture needle  22  penetrated through the top surface  11  in the axial direction of the transfer needle assembly. The skirt portion  13  has an inner diameter that enables a mouth portion of a vial (not shown) to slide along the inner wall thereof and a cutout  14 , formed on the distal end side thereof, for identifying the puncture needle  22  situated at a position where the needle is receded into the skirt portion  13 . A plurality of (generally 3 to 5) vertical ribs  15  which enable the mouth portion of the vial to slide smoothly are provided on the inner wall of the skirt portion  13 . The vertical ribs  15  are undercut with their proximal end portions retained adjacent to the top surface  11 , and stepped portions  151  formed by the undercutting come in contact with the mouth portion of the vial when the end  131  of the skirt portion  13  advances to a position where the end  131  contacts the shoulder portion of the vial.  
     [0024] The inner wall of the puncture needle insertion portion  12  is undercut with part of its proximal end retained and the puncture needle  22  of the puncture member  2  is inserted into this portion in such a manner that the puncture needle  22  can slide along the inner wall. Owing to this structure, the puncture member  2  can recede up to a position where an annular rib  224  of the puncture needle  22  to be described hereinafter is engaged with a stepped portion  121  formed by the undercutting. Therefore, the undercutting position and the position of the annular rib  224  are determined such that the tip  223  of the puncture member  2 , that is, the tip  223  of the puncture needle  22 , is receded into the skirt portion  13  when the annular rib  224  and the stepped portion  121  engage with each other (see, FIG. 7). The puncture member  2  can advance up to a position where the proximal end  122  of the puncture needle insertion portion  12  comes in contact with a collar  24  of the puncture member  2  to be described hereinafter. Therefore, the projecting length of the puncture needle insertion portion  12  from the top surface  11  is determined such that the tip  223  of the puncture member  2  projects from the skirt portion  13  when the proximal end  122  of the puncture needle insertion portion  12  comes in contact with the collar  24  of the puncture member  2  (see, FIG. 8).  
     [0025] The puncture member  2  is generally a tubular member formed from a plastic such as polypropylene, polyethylene, polyester, polycarbonate or ABS resin and a tip  223  of the puncture needle  22  is fitted in the puncture needle insertion portion  12  of the guide member  1  in such a manner that the tip  223  can slide from a position where the tip  223  is receded in the inside of the skirt portion  13  to a position where the tip  223  projects from the skirt portion  13 . The puncture member  2 , has, at the proximal end thereof, the tip fitting portion  21  into which a tip (not shown) of a syringe can be mounted and, at the distal end thereof, the puncture needle  22  to be inserted into the puncture needle insertion portion  12 .  
     [0026] In detail, the puncture member  2  is a tubular member having, at its proximal end, a tip fitting portion  21  and, at its distal end, a puncture needle  22  to be inserted into the above puncture needle insertion portion  12  and which also has a filter portion  23 . The tip fitting portion  21  comprises a cylindrical area for accommodating a syringe and for mounting a tip of the syringe and an aperture on the bottom. The aperture is preferably, crescent, semicircular, elliptical or circular, but is not limited to these shapes. The puncture needle  22  includes a tubular outer wall of which a proximal end is partly connected with the bottom of the tip fitting portion  21 , but the remaining proximal part is connected with the filter portion  23 , and a needle shaped septum continued from the aperture of the tip fitting portion  21 . The outer wall and the septum form a liquid passage from the tip fitting portion  21  to the guide member  1  and a gas passage from the filter portion  23  to the guide member  1 . The cross-sectional area of the liquid passage is preferably, crescent, semicircular, elliptical or circular, and the cross-sectional area of the gas passage is, preferably, circular.  
     [0027] The length of the septum is longer than the length of the outer wall of the puncture needle, and the distal end of the outer wall of the gas passage extends downwardly beyond the distal end of the outer wall of the liquid passage in order to prevent the air introduced into the vial from returning to the syringe.  
     [0028] The filter portion  23  is located outside of the tip fitting portion  12  and connected with the outer wall of the puncture needle  22  and is provided with an air filter  231  at the proximal end of the gas passage. The filter portion  23  is preferably located in a position where a lock-type syringe does not contact the tip fitting portion  21  and further, a position where the movements of the disk-like collar  24  and the puncture needle fitting portion  12  are not disturbed when the collar  24  comes in contact with the puncture needle fitting portion  12 . The filter portion  23  is, preferably, a cylindrical portion extending from the outside of the tip fitting portion  21  and the outer wall of the puncture needle  22 , but is not limited to this shape.  
     [0029] That is, the puncture needle  22  is provided with a liquid passage  222  which communicates with the tip fitting portion  21  and a gas passage  221  which communicates with the outside through an air filter  231  in the filter portion  23 .  
     [0030] The gas passage  221  enables outside air to be introduced into the mouth portion of the vial via the air filter  231  in the filter portion  23  and the liquid passage  222  enables a fluid to be injected into the mouth of the vial through the tip  223 . The liquid passage  222  communicates with the tip fitting portion  21 , and the gas passage  221  is open to the outside through the air filter  231  of the filter portion  23  which communicates with the gas passage  221 .  
     [0031] The vial filled with a medicine such as a biological agent usually has a reduced pressure on the inside while freeze-drying the medicine. When a syringe filled with a dissolution fluid such as saline is connected with the vial by means of the transfer needle assembly, outside air is introduced into the vial in order to release the reduced pressure. The filter portion  23  is provided in the gas passage  221  to prevent air contamination via the air filter  231 . In case of a syringe filled with a dissolution fluid and connected with the tip fitting portion  21 , air is also introduced into the vial when the dissolution fluid is introduced into the vial containing a dried medicine and mixed to prepare the medicinal solution, and the solution is returned back into the syringe again.  
     [0032] In the present invention, for example, a disk-like, preferably, sector disk-like, collar  24  may be provided at the proximal end of the puncture needle  22  so that the collar  24  comes in contact with the proximal end  122  of the puncture needle insertion portion  12  at a position where the tip  223  of the puncture member  2  projects from the skirt portion  13  to stop the sliding of puncture member  2  in a forward direction.  
     [0033] The intermediate portion of the puncture needle  22  is provided with the annular rib  224  which is engaged with the stepped portion  121  of the puncture needle insertion portion  12  at a position where the tip  223  of the puncture member  2  is receded into the skirt portion  13  to stop the sliding of the puncture member  2  in a backward direction.  
     [0034] To prevent the puncture member  2  from sliding accidentally, slide suppressing means may be provided between the collar  24  of the puncture member  2  and the top surface  11  of the guide member  1 . The slide suppressing means is suitably a spring  32  as shown in FIGS.  4  to  6  or a prop  31  having a corset function as shown in FIG. 3.  
     [0035] A description is given below of use of the transfer needle assembly of the present invention with reference to FIG. 7 and FIG. 8.  
     [0036] As shown in FIG. 7, a transfer needle assembly TN and a vial V are first prepared. The tip  223  of the puncture needle  22  is situated within the skirt portion  13 . The skirt portion  13  is applied to the mouth portion M of the vial V, the whole transfer needle assembly TN is pressed down straight, a rubber stopper RS is pricked with the puncture needle  22 , and the forward movement of the transfer needle assembly TN is stopped at a position where the puncture needle insertion portion  12  comes in contact with the sector disk-like collar  24 . At this point, the stepped portion  151  engages the mouth portion M of the vial V, and the inside of the vial V communicates with the outside air and the tip fitting portion  21  through the gas passage  221  and the liquid passage  222  of the puncture needle  22 , respectively (see FIG. 8). When the tip fitting portion  21  is connected to a syringe (not shown) filled with the fluid in this state, the dissolution procedure can be easily carried out by introducing the fluid in the syringe into the mouth portion M of the vial V.  
     [0037] As obvious from the above description, by using the present invention, the dissolution procedure can be easily carried out. Contamination of the tip of the needle and injury by the tip of the needle can be avoided and leakage of a liquid during the dissolution procedure can be prevented.