Patent Document

BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The present invention relates to a compact hypodermic syringe for injecting a pre-measured dose under adverse conditions. More particularly, the invention relates to a syringe wherein the doses are pre-loaded compressible capsules having the opening sealed by adhesive label. More particularly, the syringe is a foldable fully disposable device which after use is folded to enclose the hypodermic syringe safely. 
   2. Related Art 
   Due to the recent advent of the AIDS virus, which may be contracted by contaminated hypodermic syringes, there have been several retractable needle hypodermic syringes invented and patented. The retraction of the needle into the barrel of the syringe after use reduces the risk of “needle prick”, or the accidental pricking of the person giving the injection after the syringe has been used. 
   Some of the recently patented retractable needle syringes include U.S. Pat. No. 4,692,156 (Haller); U.S. Pat. No. 4,675,005 (DeLuccia); U.S. Pat. No. 4,747,830 (Gloyer, et al); U.S. Pat. Nos. 4,790,822 and 4,950,251. All of the syringes disclosed include a hypodermic needle mounted on a carrier which is slidable in the barrel. The plunger is locked to this carrier after the injection has been given and is withdrawn up into the barrel by withdrawal of the plunger. The simplest mechanism for locking the plunger to the carrier is disclosed as a projection on the lower end of the plunger which engages through an opening in the upper end of the carrier. 
   One disadvantage of the above syringes is that the locking mechanism takes up some space in the barrel of the syringe and may prevent all of the measured liquid from being ejected by the plunger. This problem is exacerbated in the very small syringes such as the 1 cc tuberculin type. The liquid left in the barrel may be a substantial portion of the measured dose. In addition the narrowness of the barrel of the 1 cc syringe makes it difficult to design a needle carrier and locking mechanism that will fit in the barrel without enlarging the diameter so much as to make the calibration useless. 
   Venturini in U.S. Pat. No. 5,112,316 discloses a syringe similar to the retractable needle syringes described above except Venturini adds a spring outside the upper end of the syringe between the finger flange on the top of the barrel and the bottom surface of a projection at the top of the plunger to retract the plunger into the barrel after it has been locked onto the needle carrier. Venturini suffers the same drawbacks because the plunger must still be locked to the needle carrier. 
   Also there is a need for a simple, easy to use syringe for injecting pre-measured doses of medicines. While this need has been met by syringes having the medications pre-loaded, there is still a need where the user would like to select the medicine to be injected and utilize a syringe not pre-loaded. 
   SUMMARY OF THE INVENTION 
   The present invention provides a simple, easy to use syringe which may be used under difficult circumstances. The compression bulb hypodermic syringe allows an intra-muscular injection of a measured dose of antidote against a biological or chemical agent, or the injection of medications. The simplicity of design and ease of use make the device field-adaptable for emergency, war or third-world situations. The medications are pre-loaded in a compressible capsule whose hypodermic interface is sealed from contamination by an adhesive label which creates a double seal. The label, having markings as to the contents, is peeled away before loading into the syringe. This allows the medications to be transported contamination-free to the application site in extremely dirty environments. The compressible capsule is a drop in component that can quickly and simply loaded into the syringe applicator. 
   The syringe applicator features a two-piece design comprising a needle carrier assembly and an applicator body, each molded from a single piece of plastic. The needle carrier partially encloses a double-ended hypodermic needle. The applicator is folded on a living hinge that first causes the needle carrier to move until one end of the hypodermic needle punctures the capsule seal and communicates with the medication therein. Continuing to fold the applicator compresses the capsule, thereby ejecting the medication through the opposite end of the hypodermic needle into the patient. 
   When the applicator is folded in the opposite direction completely the exposed end of the hypodermic needle is contained safely within the applicator. The invention may be thus shown to comprise: 
   (a) a first leaf having a receptacle for a collapsible container, said first leaf defining an applicator holding body: 
   (b) a second leaf defining a plunger holding body which is hinged and connected to said first leaf and having a plunger which substantially conforms in size and shape as the collapsible container and mounted on said second leaf such that said plunger can engage a collapsible container in said enclosure when said second leaf is folded over said first leaf in one direction; 
   (c) a double-ended hypodermic needle having a first end for insertion into a patient and a second end which can puncture the closure on a collapsible container within said receptacle; 
   (d) said first end being exposed and said second end puncturing said collapsible container when said second leaf is folded part way over said first leaf in the direction of (b); and 
   (e) said plunger being capable of collapsing a collapsible container contained within said receptacle when said second leaf is pressed firmly against said first leaf. 

   
     BRIEF DESCRIPTION OF THE DRAWING 
       FIG. 1  is a top perspective view of the device in the initial state with a compressible capsule loaded. 
       FIG. 2  is a top view of the device as shown in  FIG. 1 . 
       FIG. 3  is a side plan view of the device as shown in  FIG. 1 . 
       FIG. 3A  is a detailed view of the area circled in  FIG. 3 . 
       FIG. 4  is an end view in partial cross section taken along lines  4 — 4  of  FIG. 2 . 
       FIG. 5  is a bottom view of the device as shown in  FIG. 1 . 
       FIG. 5A  is a side elevational view taken along line  5 A— 5 A of  FIG. 5 . 
       FIG. 6  is a side plan view in cross section of the opposite side as that of  FIG. 3 . 
       FIG. 6A  is an enlarged cross sectional view of the area circled in  FIG. 6 . 
       FIG. 7  is a back perspective view of the device with the applicator folded and the device ready for use. 
       FIG. 8  is a front perspective view taken from the opposite angle as that of  FIG. 7 . 
       FIG. 9  is bottom of the device as shown in  FIGS. 7 and 8 . 
       FIG. 10  is a side plan view in cross section taken along line  10 — 10  in  FIG. 9 . 
       FIG. 10A  is a detailed view of the area circled in  FIG. 10 . 
       FIG. 11  is a bottom view of the device after the plunger has compressed the capsule. 
       FIG. 12  is a side plan view in cross section taken along the line  12 — 12  in  FIG. 11 . 
       FIG. 13  is a front perspective view with after the plunger has compressed the capsule. 
       FIG. 14  is a top perspective view of the device being refolded. 
       FIG. 15  is a top view of the device completely refolded 180° from the injection position. 
       FIG. 16  is an end view taken along line  16 — 16  of  FIG. 16 . 
       FIG. 17  is an exploded view of the syringe of the present invention. 
       FIG. 18  is a perspective view of the collapsible capsule assembly as used in the present invention. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   For a detailed description of the preferred embodiment the reader is referred to the appended figures in which like components are given like numerals for ease of reference. 
   For quick reference all of the reference numerals are listed in Table I below and their corresponding parts identified with the figures in which the parts are identified. The parts may be shown in other figures but are identified by the reference numerals in the listed figures only. 
   Table 1 
   
     
       
             
             
             
           
             
             
             
           
         
             
               TABLE I 
             
             
                 
             
             
               No. 
               Description 
               FIG. Number 
             
             
                 
             
           
           
             
                 
             
           
        
         
             
               1 
               Applicator holding body 
               1–3, 4–5, 5A, 6, 7–8, 10, 12–15, 17 
             
             
               2 
               Applicator plunger body 
               1–3, 4–5, 5A, 7–8, 10, 13–17 
             
             
               3 
               Needle carrier 
               1–3, 4–5, 5A, 6, 6A, 7–8, 10, 10A, 
             
             
                 
                 
               12, 15, 17 
             
             
               4 
               Vessel 
               1–3, 4, 6, 6A, 7–8, 10, 10A, 12, 118 
             
             
               5 
               Capsule holding cavity 
               1, 3, 5, 6, 6A, 7, 10, 12–13, 18 
             
             
               6 
               Capsule closure 
               1–3, 6A, 7, 10A, 12–14, 17–18 
             
             
               7 
               Capsule retaining ring 
               1–3, 6A, 7, 10A, 12–14, 17 
             
             
               8 
               Membrane 
               5, 6A, 10A, 12, 
             
             
               9 
               Driving track 
               1, 3, 5A, 8, 13, 17 
             
             
               10 
               Applicator locking slot 
               1, 3, 3A, 5A 
             
             
               11 
               Actuator pin 
               1–3, 3A, 4, 5A, 7–8, 13–15, 17 
             
             
               12 
               Hypodermic needle 
               1–2, 4, 5, 6, 1–8, 10, 10A, 12–17 
             
             
               13 
               Living hinge 
               1–3, 5, 5A, 7–8, 13–15, 17 
             
             
               14 
               Needle safety cavity 
               3, 5, 6, 8, 12–13 
             
             
               15 
               Plunger 
               1–3, 4–6, 7–8, 10, 12–17 
             
             
               16 
               Carrier aperture 
               2, 5, 8, 14–15, 17 
             
             
               17 
               Carrier retainer ring 
               1–3, 5, 6A, 10A, 12 
             
             
               18 
               Carrier sliding track 
               4, 5, 17 
             
             
               19 
               Carrier luer seal body 
               1–3, 5, 6A, 10A, 12, 17 
             
             
               20 
               Piercing needle 
               1, 5, 6A, 10A, 12, 17 
             
             
               21 
               Finger push interface 
               1, 4, 5A, 6, 17 
             
             
               22 
               Capsule inner cavity 
               6, 6A, 10, 10A, 12 
             
             
               23 
               Carrier locking notch 
               6A, 10A 
             
             
               24 
               Capsule luer seal cavity 
               6A, 10A, 12 
             
             
               25 
               Capsule closure retainer 
               6A, 10A, 12 
             
             
                 
               latch 
             
             
               26 
               Capsule retaining slot 
               1, 6A, 7, 10, 10A, 12, 14, 17 
             
             
                 
               ring 
             
             
               27 
               Safety slot 
               4, 6, 14–16 
             
             
               28 
               Capsule closure inner 
               6A, 10A, 12 
             
             
                 
               ring 
             
             
               29 
               Capsule closure inner 
               6A, 10A, 12 
             
             
                 
               wall 
             
             
               30 
               Capsule sealing ring 
               6A, 10A, 12 
             
             
               31 
               Carrier track slot 
               4, 8, 13, 17 
             
             
               32 
               Capsule compressed 
               12 
             
             
               33 
               Deflecting surface 
               16 
             
             
               34 
               Sealing label 
               18 
             
             
               35 
               Capsule assembly 
               1, 3, 6–8, 10, 12, 14, 17, 18 
             
             
               36 
               Vessel neck 
               6A 
             
             
               37 
               Locking slot detent 
               3, 3A 
             
             
                 
             
           
        
       
     
   
   Referring first to  FIGS. 1 and 2 , the device is shown in its initial state with the applicator holding body  1  and the applicator plunger body  2  are molded as one plastic part along with and connected by a flexible living hinge  13 . The two bodies are in the form of rectangular leaves or slabs. In  FIG. 4  the needle carrier  3  is seen to be captured laterally and vertically by a carrier track slot  31  contacting the carrier sliding track  18 .  FIG. 3  shows that actuator pin  11  is captured by applicator locking slot  10  on the needle carrier  3  preventing any angular motion around the pivot point defined by the living hinge  13 . Locking slot detent  37 , located in the applicator locking slot  10 , allows a light snap fit between actuator pin  11  and the needle carrier  3  to temporarily retain the needle carrier  3  in this locked position. The distal end of the hypodermic needle  12  is safely stowed in the needle safety cavity  14 . 
   Referring now to  FIGS. 1 ,  6 A and  18 , capsule assembly  35  comprising collapsible vessel or container  4 , capsule closure  6  and capsule closure inner ring  28 , is positioned in the applicator holding body  1 . This capsule assembly contains a pre-loaded medication dose in the capsule inner cavity  22 . The inner cavity  22  is sealed by compressing the vessel neck  36  between the capsule closure wall  29  and the capsule sealing ring  30  located on the capsule closure inner ring  28 . This seal is retained by the capsule closure retainer latch  25  snapping into the capsule closure inner ring  28 . The inner cavity  22  is also sealed by membrane  8  located in the capsule closure  6 . The sealing label  34 , as shown on  FIG. 18 , seals the capsule luer seal cavity  24  and the membrane  8  from contaminants. The capsule assembly  35  is positioned by capsule holding cavity  5 . Due to the elastic properties of the vessel  4 , an additional retainer comprising capsule retaining ring slot  26  on applicator holding body  1  and capsule retaining ring  7 , part of the capsule closure  6 , is required to hold the capsule assembly  35  stable. 
   Operation 
   Referring to  FIGS. 5 and 5A , needle carrier is pushed by means of finger push interface  21  to a position where the actuator pin  11  is in the driving track  9 . This allows angular movement of living hinge  13  between applicator holding body  1  and applicator plunger body  2 . As seen in  FIG. 17 , the plastic needle carrier  3  is molded around the hypodermic needle  12  creating piercing needle  20  at the proximal end and hypodermic needle  12  at the distal end. Hypodermic needle  12  is thus a double ended canula and sharp at both ends. 
   As seen in  FIGS. 7 and 8 , folding the applicator plunger body  2  along living hinge  13  toward the applicator holding body  1  drives actuator pin  11  towards the distal end of the applicator holding body  1  in a circular motion as defined by a pivot point along the axis of living hinge  13 . This motion is translated to the needle carrier  3  by means of the driving track  9 . The needle carrier  3  travels through the carrier aperture  16  and along sliding track  18 , captured by carrier track slot  31 , until the circular driving track  9  axis becomes coincident with the axis of the living hinge  13 . At this point the actuator pin  11  travels concentric to the circular driving track  9  and further lateral movement of the needle carrier  3  is stopped. 
   At this point, as seen in  FIG. 10A , the needle carrier  3  has pushed needle  20  through membrane  8  in the capsule closure  6  allowing medication to flow through to hypodermic needle  12 . Also, carrier retainer ring  17  has permanently snapped into carrier locking notch  23  and carrier luer seal body  19  on the needle carrier  3  has seated into capsule luer seal cavity  24  to form a luer seal. 
   In the injection phase, further folding of the applicator plunger towards the applicator holding body  1  as shown in  FIGS. 7 and 8  causes the plunger  15  to contact the vessel  4 . The vessel  4  is made from a pliable elastomer and is collapsed by the plunger  15  which is shaped to substantially conform to the vessel. The vessel collapses, reducing the volume of the inner cavity  22  thereby pushing the contents of the vessel through hypodermic needle  12 . 
   Referring now to  FIGS. 14–16 , storage of the needle is shown after injecting the medication. The needle  12  is stowed in a safe position inside plunger  15  by folding the applicator body  2  180° allowing the hypodermic needle  12  to pass through the carrier aperture  16  and into the safety slot  27 . Continuing to fold causes the hypodermic needle  12  to be sprung to one side by deflecting surface  33  and then captured by snapping back to its normal position in the top of the safety slot  27 . 
   The foregoing description of the invention has been directed to a particular preferred embodiment of the present invention for the purposes of explanation and illustration. It will be apparent to those skilled in the art that many modifications and changes in the apparatus may be made without departing from the scope and spirit of the invention. It is therefore intended that the following claims cover all equivalent modifications and variations as fall within the scope of the invention as defined by the claims.

Technology Category: 1