Abstract:
A catheter device is disclosed which the hypodermic needle used for insertion is retracted into a protective sheath and left in place during use. An IV fluid flow path is provided that is blocked by the hypodermic needle prior to retraction but is opened by the retraction of the needle from the catheter. The insertion hypodermic needle is not discarded separately but only after the use of the whole catheter device to inject fluids.

Description:
BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The present invention relates to a device for the insertion of a flexible catheter into a vein of a patient for intravenous administration of fluids. More Particularly the invention relates to devices wherein the flexible catheter is inserted into the vein by a sharp needle about which the catheter is snugly mounted, and the needle and catheter are inserted into the vein and the needle retracted leaving the catheter in place. More particularly the invention relates to a catheter insertion device wherein the insertion needle is retractable into the device after removal. Most particularly the invention relates to a catheter insertion device with an integral IV port wherein the insertion device is directly connected to the IV fluid source. 
   2. Related Art 
   The development of flexible intravenous catheters has greatly increased the comfort of patients during intravenous administration of medicinal fluids. The flexible catheter prevents unwanted puncture of the vein. The flexible catheter normally consists of a narrow tube of NYLON or TEFLON construction with a rigid member attached at the rear end for connection to the source of fluid to be administered. 
   Because the catheter is flexible it cannot by itself be inserted into the vein. Therefore, the catheter is snugly nested about a sharp hypodermic type needle which can be inserted into the vein. After insertion the sharp needle is withdrawn leaving the catheter in place for connection to the fluid source. The insertion needle is usually discarded as it is intended for a single use only. Often the needle is discarded in a careless manner leaving the exposed needle point as a hazard. 
   Accidental needle prick has been a problem for years in the health care industry. However, the advent of the HIV or AIDS virus has focused attention on the problem. While several diseases, such as viral hepatitis, may be contracted from bodily fluids of infected persons, HIV has caused the most concern because to date no preventative or cure is known. Protection against accidental needle prick is expected to remain a concern even after a vaccine or cure is found, an ounce of prevention being worth a pound of cure. 
   Earlier U.S. Pat. Nos. 5,019,019 and 5,176,650 have addressed this problem in regard to catheter insertion devices. 
   SUMMARY OF THE INVENTION 
   To protect against accidental needle prick a catheter and insertion device are provided wherein the needle is retractable within the device after insertion of the catheter. The device comprises a hollow barrel or tube of semi-rigid plastic material into which the needle can be retracted after use. The insertion needle is mounted on a carrier with the sharp end oriented toward the insertion end of the barrel with the catheter snugly fit about the needle. A sliding tab is mounted to the carrier by an outwardly biased flexible member and extends through a longitudinal sliding track in the barrel. Near either end of the sliding track notches to engage locking hubs on the sliding tab to releasably lock the carrier in either the exposed or retracted position. The catheter and catheter carrier are secured to the needle carrier by a releasable latch that is released when the needle, needle carrier, catheter and catheter carrier are in the fully exposed position. A retainer ring holds the catheter carrier and catheter in position after retraction of the needle and needle carrier. The needle is retained inside the device during in use. 

   
     BRIEF DESCRIPTION OF THE DRAWING 
       FIG. 1  shows the device ready for insertion into a vein with the hypodermic needle and catheter fully exposed. 
       FIG. 2  shows the device in the fully retracted position. 
       FIG. 3  shows the device after the catheter has been inserted and the hypodermic needle retracted. 
       FIG. 4  is a side plan view of the device with the catheter and needle in the retracted position. 
       FIG. 5  is a top plan view of the device with the catheter and needle in the retracted position. 
       FIG. 6  is a cross sectional view taken along line  6 — 6  of  FIG. 4 . 
       FIG. 7  is a cross sectional view taken along line  7 — 7  of  FIG. 5 . 
       FIG. 8  is top plan view of the device with the catheter and needle in the exposed position. 
       FIG. 9  is a cross sectional view of the device taken along line  9 — 9  of  FIG. 8 . 
       FIG. 10  is a cross sectional view of the device taken along line  10 — 10  of  FIG. 8 . 
       FIG. 11  is a cross sectional view taken along line  11 — 11  of  FIG. 10 . 
       FIG. 12  is a top plan view of the device with the catheter in the exposed position with the hypodermic needle retracted. 
       FIG. 13  is a side plan view of the device with the catheter in the exposed position with the hypodermic needle retracted. 
       FIG. 14  is a cross sectional view of the device taken along line  14 — 14  in  FIG. 12 . 
       FIG. 15  is a cross sectional view of the device taken along line  15 — 15  in  FIG. 12 . 
       FIG. 16  is an enlarged view of the area circled in  FIG. 15 . 
       FIG. 17  is a perspective exploded view of the device form the right side. 
       FIG. 18  is a perspective exploded view of the device form the left side. 
   

   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 I 
             
             
                 
             
             
               Ref. No. 
               Description 
               Identified in Figure Number: 
             
             
                 
             
           
           
             
                1 
               protective sheath 
               1–3, 6–7, 10–11, 16–18 
             
             
                2 
               port body 
               1–3, 5, 9–11, 14–18 
             
             
                3 
               needle carrier 
               1–3, 6–7, 9–11, 14, 17–18 
             
             
                4 
               catheter 
               1, 3, 6–7, 9–10, 14, 16–18 
             
             
                5 
               IV tube 
               1–3, 9, 14–15, 17–18 
             
             
                6 
               hypodermic needle 
               1, 6–7, 9–10, 14, 16–18 
             
             
                7 
               catheter carrier 
               1–3, 6, 10–11, 14, 16–18 
             
             
                8 
               needle locking tab 
               1–3, 5, 9, 14, 17–18 
             
             
                9 
               needle locking slot 
               1–4, 8–10, 14, 17, 18 
             
             
                9A 
               needle locking slot 
               1–4, 7–9, 17–18 
             
             
               10 
               needle carrier track 
               1–3, 7–8, 10, 17–18 
             
             
               11 
               actuator 
               4, 7, 9–10, 14, 17–18 
             
             
               12 
               flashback sight tube 
               7–8, 10, 17–18 
             
             
               13 
               indicator 
               7–8, 17–18 
             
             
               14 
               actuator spring 
               7, 9–10, 17–18 
             
             
               15 
               rear retainer ring 
               7, 10–11, 14, 18 
             
             
               16 
               flow cavity 
               7, 9, 15–16 
             
             
               17 
               catheter retainer 
               7, 10, 14, 17–18 
             
             
                 
               slot 
             
             
               18 
               membrane 
               6–7, 9–10, 14, 16, 18 
             
             
               19 
               needle carrier slot 
               18 
             
             
               20 
               catheter taper 
               7, 9, 18 
             
             
               21 
               catheter carrier 
               7, 10, 14, 17–18 
             
             
                 
               retainer ring 
             
             
               22 
               retainer ring relief 
               7, 17–18 
             
             
                 
               slot 
             
             
               23 
               flashback blood path 
               7, 10 
             
             
               24 
               needle retainer 
               9 
             
             
                 
               notch 
             
             
               25 
               membrane aperture 
               16 
             
             
               26 
               forward retainer 
               6, 11, 17–18 
             
             
                 
               spring 
             
             
               27 
               forward locking 
               6, 11, 17–18 
             
             
                 
               surface 
             
             
               28 
               needle carrier 
               6–7, 11 
             
             
                 
               release tab 
             
             
               29 
               needle carrier 
               6, 11 
             
             
                 
               release ramp 
             
             
               30 
               forward catheter 
               6, 11 
             
             
                 
               locking surface 
             
             
               31 
               conical ramp 
               7, 10–11, 18 
             
             
               32 
               IV liquid flow path 
               16 
             
             
               33 
               rear retainer slot 
               14 
             
             
               34 
               port body retainer 
               16, 18 
             
             
                 
               surface 
             
             
               35 
               locking ramp 
               16, 18 
             
             
                 
             
           
        
       
     
   
   Referring first o  FIGS. 17 and 18  the components of the catheter device are seen in exploded views. The device is seen to comprise a protective sheath  1  having a longitudinal slot or needle carrier track  10  on one surface with needle locking slots  9  and  9 A near either end of the carrier track  10 . The catheter is seen to have a near quarter round cross sectional or tear drop area with the needle and catheter in the largest area and adjacent the flat for ease of use and insertion of the needle and catheter (this can best be seen by looking at the internal parts which conform to the cross sectional area of the sheath such as membrane  18  and port body retaining surface). A catheter retaining ring  21  and retaining ring slot  22  are located at the proximal end along with an aperture through which the hypodermic needle and catheter may be exposed. The catheter  4  and catheter carrier  7  are mounted on the needle carrier  3  with membrane  18  between the two. As assembled for shipment the hypodermic pierces the membrane  18  and fits into the catheter  4 . On top of the needle carrier  3  is actuator  11  which is connected to the needle carrier  3  by actuator spring  14 . On either side of actuator  11  are needle locking tabs  8  which may engage needle locking slots  9  and  9 A. At the rear of the needle carrier  3  is flashback sight tube  12  which contains flashback indicator  13 . located alongside needle carrier  3  is port body  2  having flow cavity  16  which is aligned with membrane aperture  25 . The IV fluid tube  5  is connected to the port body. 
   Referring now to the  FIG. 1  the device is shown in perspective view in the ready mode with the catheter  4 , catheter carrier  7  and hypodermic needle  6  fully extended from the sheath  1  with the hypodermic needle  6  locked into this position by the needle locking tab  8  engaging the needle locking slot  9 A. The IV tube  5  is shown connected to the port body  2 . The needle carrier  3  is shown extending through the needle carrier track  10 . 
   In  FIG. 2  the device is shown in the stowed mode as for shipment with the catheter and needle fully retracted into the sheath  1  and the hypodermic needle locked into position by the needle locking tab  8  engaged in the needle locking slot  9 . The catheter is fixed in a locked and stowed position by the catheter carrier  7 . 
     FIG. 3  shows the device as it would be used delivering IV fluids to a patient with the catheter  4  fully extended and the hypodermic needle retracted into the sheath  1 . The hypodermic needle is locked into the retracted position by the needle locking tab  8  engaged in the needle locking slot  9 . 
   Referring now to  FIGS. 4–7  details of the needle, needle carrier, catheter and catheter carrier in the stowed position carrier are shown.  FIGS. 4 and 5  are plan views shown to provide an orientation basis for  FIGS. 6 and 7  which are cross sectional views. In  FIG. 7  the needle  6  and catheter  4  are placed in the stowed and safe position by sliding them longitudinally in the inner cavity of the protective sheath  1  to a position where the needle  6  and catheter  4  cannot be touched. The hypodermic needle  6  is securely fastened to the needle carrier  3  which is locked into position by actuator spring  14  applying pressure to needle locking tab  8  ( FIG. 5 ) to needle locking slot  9  ( FIG. 4 ), thereby preventing any further longitudinal movement. The spring  14  must be strong enough to bias the tab into the slot, otherwise a coiled spring (not shown) may be placed beneath the spring  14  to add force to bias the tab into the slot. 
   As shown in  FIG. 6  the catheter  4  is securely fastened to the catheter carrier  7 . The catheter carrier  7  is connected to the needle carrier  3  by the forward retainer spring  26  on the needle carrier  3  engaging an interference fit between the forward locking surface  27  on the forward retainer spring  26  and the catheter locking surface  30  on the catheter carrier  7 . 
   Referring now to  FIGS. 8–11  details of the needle, needle carrier, catheter and catheter carrier in the exposed position are shown. As shown in  FIG. 8  the hypodermic needle  6  and catheter  7  are moved to the fully extended position along with port body  2  by depressing actuator  11  against the force of the actuator spring  14  to disengage the needle locking tab  8  ( FIG. 9 ) from the needle locking slot  9  allowing the needle carrier  3  and the catheter carrier  7  to slide longitudinally within the confines of the needle carrier track  10  ( FIG. 10 ) and in the inner cavity of the protective sheath  1 , to a position where the needle locking tab  8  can engage and lock the forward needle locking slot  9 A. 
   Referring now to  FIG. 10 , the conical ramp  31  located on catheter carrier  7  deforms the molded shape of the protective sheath  1 , relieved by, as best shown in  FIG. 17 , the retainer ring relief slot  22 , to allow the catheter retainer slot  17 , a molded feature of the catheter carrier  7 , to lock into the carrier retainer ring  21 , a molded feature of the protective sheath  1 . In this longitudinally locked exposed position the hypodermic needle  6  and catheter can pierce a vein and start an IV injection. The catheter  4  has catheter taper  20  to allow a less painful insertion into the vein. As an indication that a vein has been entered, blood under pressure flows through the hypodermic needle  6  along the flashback blood path  23  and id absorbed in an absorbent indicator  13  located in the flashback sight tube  12 . The flashback sight tube  12  is molded from clear plastic and can be viewed through the opening in the needle carrier track  10  as shown in  FIG. 8 . 
   With the hypodermic needle  6  in the extended position no IV fluid can flow due to the close fit between the hypodermic needle  6  and the catheter  4 . This allows the IV fluids to be connected to the device before a vein is pierced. Air can be purged from the system prior to the application of the IV needle. 
   Referring now to  FIG. 11  when the needle carrier  3  and the catheter carrier  7  is in the fully extended and locked position, the forward retainer spring  26  slides onto the needle carrier release ramp  29  located on the needle carrier release tab  28 , a molded feature of the protective sheath  1 , and disengages the forward locking surface  27  from the forward catheter locking surface  30 . This allows the needle carrier  3  to be retracted separately from the catheter carrier  7 . The catheter carrier  7  and the catheter  4  remain locked, extended and in the vein. 
   Referring now to  FIGS. 12–16  the operation of the device with the needle in the retracted position is shown. The hypodermic needle  6  is moved to the fully retracted position by depressing actuator  11  against the force of the actuator spring  14  to disengage the needle locking tab  8  from the needle locking slot  9 A allowing the needle carrier  3  to slide longitudinally constrained by the needle carrier track  10  and in the inner cavity of the protective sheath  1  to a position where the needle locking tab  8  can engage needle locking slot  9 . The rear retainer tab  15  located on the needle carrier  3  snaps into the rear retainer slot  33  located on the port body  2 . The needle carrier  3  is retained by this patient tamper proof mechanism formed by the rear retainer tab  15  and rear retainer slot  33 . 
   With the needle carrier  3  and the hypodermic needle  6  in the retracted position and the catheter in the extended position, the hypodermic needle  6  no longer passes through the membrane  18 . This membrane, made from an elastomer, allows an elastic aperture, formed by the initial hypodermic needle  6  penetration, to close. 
   Referring now to  FIGS. 15 and 16  the membrane  18  forms a seal as the hypodermic needle  6  is removed and also forms a compressed gasket seal between the catheter carrier  7  and the port body  2 . This seal is maintained by the locking ramp  35  on opposing sides of the port body  2  coming into contact with the port body retainer surface  34 , creating a snap interference fit to compress membrane  18  at the contact surfaces. 
   When the hypodermic needle  6  is in the retracted position the IV fluids are free to flow in the flow cavity  16  along flow path  32 , through the IV tube  5 , through the port body  2 , through membrane aperture  25  (best seen on  FIG. 18 ) through catheter carrier  7  and catheter  4  to the vein.