Patent Abstract:
Invention relates to catheter placement devices for peripheral blood vessel catheterization with protected needle tip and shortened length in a transport position (see FIG.  31 ). In the transport position (FIG.  9 ), the needle and catheter units ( 1  and  5 ) are held inside the handle ( 8 ). User transposes the needle and catheter units into a duty ready position ( FIG. 6 ), wherein the needle unit is engaged with the handle distal end and a catheter hub ( 7 ) protrudes distally out of the handle. After catheter insertion into patient vein, user disconnects the needle unit and handle allowing the needle unit retraction by a resilient member ( 11 ) into the protection position. The trigger and transposing means ( 22 ) location enables the apparatus single handed control. The fixation means ( 31 ) in the protection position eliminates repeated needle unit advance. It can be used rubber or spiral spring resilient members and the catheter hubs with foldable side wings and side port.

Full Description:
This application is a national phase of International Application No. PCT/IL02/00119 filed Feb. 17, 2002 and published in the English language. Priority of Israel patent application No. 141574 filed Feb. 21, 2001 also is claimed via the aforesaid International Application. 
   FIELD OF INVENTION 
   This invention generally relates to the catheter placement devices for intravascular catheterization and more particularly to the catheter insertion apparatus for peripheral blood vessel catheterization with a needle tip protective system and shortened length in the transport position. 
   BACKGROUND 
   The catheter insertion apparatus for intravascular catheterization includes, as a rule, a catheter unit with a catheter tube and a catheter hub, a needle unit with a tubular needle and a needle hub as well as a hollow handle. Prior to use in the duty ready position, they are assembled so that the sharp distal point of the needle extends beyond the distal end of the catheter tube and the catheter tube extends beyond the distal end of the hollow handle. The user advances the catheter into the blood vessel and withdraws the needle unit leaving the catheter in the blood vessel. To prevent the user from being pricked, the withdrawn needle is transposed into the protection position avoiding the transmission of the infection by the blood contaminated needle. In this position, the needle unit is disposed inside the hollow handle and the needle sharp distal point is disposed in a security zone ruling out contact by the user with said sharp distal point. Thus, prior to use, the device has a relatively long length, which approximately is equal to the sum of the hollow handle length and the catheter unit length. In the protection position, the apparatus is substantially shorter because the needle unit is housed inside the hollow handle. In the development of modern catheter placement devices, there has been a tendency to reduce the device length in the transport and storage positions as well. This provides definite advantages such as the lower packaging and transportation cost. In said transport position, the device is compact because the catheter unit and the needle unit are positioned inside the hollow handle. Immediately before use, the apparatus is converted into the above duty ready position. Mentioned compact catheter insertion apparatus has to meet the following requirements:
         Minimal length at the transportation and storage stages;   Easy conversion into the duty ready position;   Convenience of catheter placement;   Minimal number of unusual, non-customary manipulations;   Possibility of one handed trigger activation allowing for apparatus retraction into the protection position using the same hand which holds the apparatus;   Reliability of triggering off the means retracting the needle unit into the protection position;   Low manufacturing cost due to the easy of details fabrication and their assembly and also the decrease of the details number and material consumption.
 
There are many catheterization devices having mentioned transport, duty ready, and protection positions.
       

   U.S. Pat. No. 4,988,339 discloses Retractable needle/syringe devices for blood collection, catheterization and medicinal injection procedures. The devices are comprised the needle unit in the form of a syringe and the catheter unit received in an oblong hollow handle with a retracting spring disposed in the hollow handle distal portion around the needle coaxially to it and the pusher of the needle unit, disposed axially at proximal handle face. The pusher is designed for manual transposition of the needle unit from the transport position into the duty ready position. The hollow handle is provided with slots for the transposition inside them a manual controlled drive of syringe piston and trigger member. The latter is designed for the control of needle unit retraction into the duty ready position. The disadvantage of this device is its great length caused by the needle unit pusher, which, in the transport position, protrudes in proximal direction and thereby increases the device length. Moreover, the necessity to provide the definite stroke of the syringe piston drive adds to the devices length and leads to the growth of material consumption. Another disadvantage is the absence of direct access to the catheter hub in the duty ready position (see FIG. 5 of U.S. Pat. No. 4,988,339). This impedes the control of the catheter by the user during catheter insertion into the patient&#39;s vein. Another disadvantage is the mutual disposition of the handle, the trigger member, and the pusher ruling out the possibility of the device control by the same hand, which holds the device. The device consists of many details including the proximal lid of the handle and the pin of the syringe piston drive, demanding separate fabrication and assembly. Other part of the details, such as the handle, syringe barrel, and piston, include many slots and notches, which significantly complicate their fabrication. As a result, the manufacturing cost of the device grows substantially. Another disadvantage is the possibility of the needle unit exit from the protection position as a result of the action onto accessible pusher and fixation means. 
   U.S. Pat. No. 5,480,385 discloses a self-retracting medical needle apparatus, which is comprised a needle unit and a catheter unit received in a hollow handle (container) in the transport position. The catheter unit is covered with a sheath having a tab on its distal end for the transposition of the catheter unit and the needle unit from the transport position into the duty ready position. The needle hub consists of two parts movable and immovable relatively the needle. They are connected with a frangible link. The part, immovable relative to the needle, is movable and hermetically sealed with respect to the interior of the hollow handle. The vacuum arises in the interior of the handle as a result of the needle hub transposition into the duty ready position. This vacuum creates a retracting force, which returns the needle unit into the protection position when the user ruptures the frangible link by a trigger. The movable part of the needle hub in the protection position retains at the hollow handle distal end. The disadvantage of the apparatus is its increased length in the transport position due to the protrusion of the sheath tab distally from the hollow handle distal end as well as increased length of the needle caused by applying the needle hub part movable relative to the needle. Another disadvantage is the unreliability of the retracting mechanism based on the vacuum force, which demands very tight sealing. Such sealing creates unstable friction between the needle hub and the hollow handle leading to jamming of the needle unit on the way to the protection position. The presence of this problem is corroborated with later U.S. Pat. No. 6,086,563 where an attempt was made to solve this problem. Another disadvantage is the increased outside diameter of the hollow handle caused by the necessity to provide free movement of the catheter hub inside the handle because the catheter hub is encircled with the sheath, having an inner thread, as well as a circular engagement recess on the hub movable part, which is located over the sheath. Said increased diameter impedes adjoining the catheter tightly to the patient&#39;s skin creating catheterization problems. Another disadvantage is the impossibility of converting the apparatus into the duty ready position by the same hand, which holds the apparatus. Moreover, said conversion is complicated by the necessity to remove the sheath after transposing the catheter unit into the duty ready position. The apparatus has a great number of the details including the sheath, proximal lid of the hollow handle and the means of needle hub sealing. There are very complex details—a needle hub consisting of two parts, a thread, recesses and unusual flash chamber. Along with the above mentioned increased length that adds to material consumption and fabrication complexity increasing the manufacturing cost of the apparatus. 
   U.S. Pat. No. 6,086,563 discloses Needle retraction mechanism with push start retraction, which includes: a needle unit with a cantilever resilient arm on the needle hub, a catheter unit, a needle cover with distally protruded tip for the transposition of the needle unit from the transport position into the duty ready position (called “extended position” in this patent). The needle unit, the catheter unit and the needle cover are housed in a hollow handle in the transport position. The hollow handle is provided with a trigger member (called “tab” in this patent) interacting with the cantilever arm of the needle hub. There also is a retracting mechanism (called “biasing mechanism” in this patent) founded on creating a vacuum force in the hollow handle as it was made in the previous U.S. Pat. No. 5,480,385. U.S. Pat. Nos. 5,480,385 and 6,086,53 have many of the same deficiencies. One disadvantage is the low reliability of the vacuum retracting mechanism in connection with the friction between the needle hub and the hollow handle. An attempt was made to solve this problem in U.S. Pat. No. 6,086,563 by specially configuring the interacting surfaces of the trigger member and the cantilevered arm. With this method, an axially directed constituent of force is created to overcome the friction force impeding the needle unit movement into the protection position. However, it should be taken into consideration that such a measure is effective only within reach of the trigger member, i. e. over the length of the short distal portion, and cannot overcome a jam in the middle and proximal portions of the hollow handle. 
   The apparatus according to U.S. Pat. No. 6,086,563 has increased length in the transport position because of the needle cover protruding distally beyond the hollow handle and the trigger member disposition at the distal end of the hollow handle beyond the needle. This apparatus also has a large number of details including the needle cover, a proximal lid of the hollow handle, a rubber cuff of the needle hub, a very complex needle hub with the cantilever arm, a recess for the needle cover engagement, a complicated flash chamber, and the holder of the rubber cuff. The increased length and fabrication complexity add to material consumption and, as a result, the manufacturing cost of the apparatus growths. 
   Thus, common disadvantages of the apparatuses with the transport position according to the prior art are:
         Large length leading to increased material consumption and transportation expenses.   Inconvenience in operation due to the impossibility of controlling the device with one hand.   Low reliability of automatic conversion of the apparatus from the duty ready position into the protection position.   Relatively high manufacturing cost due to a large number of details, their complexity, and great material consumption.   Limitation on the application of catheter various types, in particular the catheters with hub having a side port and wings for attaching the catheter to patient&#39;s skin.   Possibility of the needle unit displacement from the protection position leading to personnel infection by blood contaminated needle.       

   SUMMARY OF THE INVENTION 
   The objective of the present invention is to reduce the transportation and packaging expenses of the compact catheter insertion apparatus. 
   Another objective is to allow the apparatus control using one hand. 
   Another objective is to provide reliable automatic retraction of the needle unit into the protection position. 
   Another objective is to lower the manufacturing cost of the apparatus by reducing the number of details and their simplifying. 
   Another objective is eliminating the possibility of the needle accidental dislodging from the protection position. 
   Another objective is to provide high ergonomics of the apparatus by decreasing the number of manipulations especially the manipulations unaccustomed for the user. 
   Another objective is extending the application field of various types of the catheter hubs in the catheter insertion apparatus with the transport position including the catheter hubs with a side port and side flexible wings for attaching the catheter hub to patient&#39;s skin. 
   Another objective is eliminating the possibility of the needle unit displacement from the protection position. 
   The above noted objectives of the present invention are accomplished by the compact catheter insertion apparatus comprising: a needle unit with a needle, a needle distal sharp point, and a needle hub, a catheter unit with a catheter tube and a catheter hub, and a handle. Their mutual dispositions are determined with their transport, duty ready, and protection positions. The apparatus contains a retracting means for the retraction of the needle unit from the duty ready position to the protection position, including a resilient member installed beyond a blood flow between the handle and the needle unit and having a maximal stressed state in the duty ready position. 
   The apparatus also includes a duty fixation means for releasable fixation of said needle unit to the handle in the duty ready position. This means includes a latch member movable in transverse direction and an immovable engagement member, one of which is disposed on the needle unit and the other on the handle. Moreover, there is a trigger member for actuating said latch member and thereby said retracting means, which in the duty ready position is disposed at the handle distal portion so that there is a possibility to control the trigger member by the same user&#39;s hand, which holds the apparatus. 
   The described retracting means with the resilient member and said trigger member provide reliable automatic retraction of the needle unit into the protection position. At the same time, noted disposition of the trigger member provides one-handed control and enhances the ergonomics level of the apparatus. 
   The resilient member having the maximal stressed state only in the duty ready position prevents the resilient member&#39;s elasticity from the deterioration during the long storage of the apparatus in the transport position. This is due to the minimal stressed state of the resilient member in the transport position. Moreover, this enables the application of inexpensive rubber resilient members in the form of a ring, which are easily secured to the needle unit and the handle. Described rubber resilient member and its disposition are novel and reduce manufacturing cost. 
   In the developed version embodiment, the latch member, trigger member, and needle hub are made as a single unit. In another version embodiment, the latch member, trigger member, and handle are made as a single unit. As a result, a minimal quantity of apparatus details and a low manufacturing cost are achieved. 
   The invention includes the version of resilient member disposed eccentrically with respect to the needle, in lower part of the handle under handle internal cavity and beyond the catheter unit in the transport position. This design enables a substantial reduction in the dimensions of the resilient member, particularly in its embodiment as a spiral spring, and reduces the dimensions of the apparatus as a whole. As a result, the manufacturing cost is reduced further. Moreover, said eccentric resilient member location facilitates the use of the catheter hub with a side port and side flexible wings in the apparatus with the transport position. Such application of the noted catheter hubs according to the present invention is novel and extends the application field of the apparatus having the transport position. 
   The present invention contains a transposing member located on the upper surface of the needle hub. It is designed for manual transposition of the catheter unit from the transport position into the duty ready position. Such disposition of the transposing member shortens the overall length of the apparatus in the transport position reducing transportation and packaging expenses. Moreover, such disposition of the transposing member enhances the convenience of its control as well as reduces the expenses for the manufacturing and the assembly of the apparatus since the transposing member and the needle unit are made as a single unit. 
   The present invention contains a protection fixation means for the fixation of the needle unit in the protection and transport positions, including the resilient member as well as a springy locking member and a notch located on the needle hub and the handle. Moreover, there is a safety lock means designed for enhancing the reliability of the prevention of the needle distal sharp point from going out of the protection position. In developed version embodiments, the members of said safety lock means are made as a single unit with the trigger member or with the handle and the needle hub and do not increase the number of the details or their cost. The introduction of said safety lock means as an addition to said protection fixation means is novel for devices of this type and completely rules out the possibility of accidental needle exit from the protection position. 
   In version embodiment, the protection fixation means is made as a non-reversible means eliminating the movement of the needle unit from the protection position without the mentioned additional safety lock means. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIGS. 1 to 9  show a compact catheter insertion apparatus, including:
         an eccentric rubber resilient member; trigger and latch members disposed on the handle; a safety means in form of a distal lid of the handle, wherein:       
       FIG. 1  shows a side elevation of the apparatus in the transport position. 
       FIG. 2  shows a top plan view of the apparatus in the transport position. 
       FIG. 3  shows a longitudinal section of the apparatus in the transport position. 
       FIG. 4  shows a view to the right of the apparatus. 
       FIG. 5  shows a cross section of the apparatus in the transport position. 
       FIG. 6  shows a longitudinal section of the apparatus in the duty ready position. 
       FIG. 7  shows a longitudinal section of the apparatus in the process of the catheter insertion into patient&#39;s vein. 
       FIG. 8  shows the apparatus in the protection position with unclosed a distal handle lid. 
       FIG. 9  shows the apparatus with operating safety means, that is to say, with closed distal handle lid. 
       FIGS. 10 to 14  show a compact catheter insertion apparatus, including:
         a resilient means made as a compression spiral spring with a coaxial disposition relative to the handle; latch and trigger members located on the oblong cantilever arm connected with the handle; a safety means made as a notch on the needle hub and a projection on the handle, wherein:       
       FIG. 10  shows a side elevation of the apparatus in the transport or protection position. 
       FIG. 11  shows a longitudinal section of the apparatus in the transport position. 
       FIG. 12  shows a side elevation of the apparatus in the duty ready position. 
       FIG. 13  shows a longitudinal section of the apparatus in the duty ready position. 
       FIG. 14  shows a longitudinal section of the apparatus in the protection position. 
       FIGS. 15 to 20  show a compact catheter insertion apparatus, including:
         a resilient member in form of compression spiral spring of small diameter with eccentric disposition relative to the needle; a latch member disposed on the needle unit; a trigger member disposed on the handle; a safety means made as a locking arm disposed at a distal portion of the handle, wherein:       
       FIG. 15  shows a side elevation of the apparatus in the transport position. 
       FIG. 16  shows a top plan view of the apparatus in the transport position. 
       FIG. 17  shows a longitudinal section of the apparatus in the transport position. 
       FIG. 18  shows a longitudinal section of the apparatus in the duty ready position. 
       FIG. 19  shows a longitudinal section of the apparatus in the process of the catheter insertion into patient&#39;s vein. 
       FIG. 20  shows a longitudinal section of the apparatus in the protection position with operating safety means, that is to say, with the locking arm turned downward. 
       FIGS. 21 to 28  show a compact catheter insertion apparatus, including:
         resilient member made as a rubber member with eccentric disposition relative to the needle axis; intermediate bush having an engagement member of the duty fixation means and serving as well as a safety means; a latch and trigger members disposed on the needle hub; a catheter hub with central and side ports and with side foldable wings, wherein:       
       FIG. 21  shows a top plan view of the apparatus in the transport position. 
       FIG. 22  shows a side elevation of the apparatus in the transport position. 
       FIG. 23  shows a longitudinal section of the apparatus in the transport position. 
       FIGS. 24 ,  25  show cross sections of the apparatus in the transport position. 
       FIG. 26  shows a longitudinal section of the apparatus in the duty ready position. 
       FIG. 27  shows a longitudinal section of the apparatus in the process of the catheter insertion into patient&#39;s vein. 
       FIG. 28  shows a longitudinal section of the apparatus in the protection position. 
       FIGS. 29 to 39  show a compact catheter insertion apparatus including a catheter with central and side ports and side foldable wings, as well as with non-reversible protection fixation means, wherein: 
       FIG. 29  shows a side elevation of the apparatus in the transport position. 
       FIG. 30  sows a top plan view of the apparatus in the transport position. 
       FIG. 31  shows a longitudinal section of the apparatus in the transport position. 
       FIGS. 32 ,  33 ,  34 ,  35  show cross sections of the apparatus in the transport position. 
       FIG. 36  shows a top plan view of the apparatus in the duty ready position. 
       FIG. 37  shows a longitudinal section of the apparatus in the duty ready position. 
       FIG. 38  shows a longitudinal section of the apparatus in the process of the catheter insertion into patient&#39;s vein. 
       FIG. 39  shows a longitudinal section of the apparatus in the protection position. 
       FIGS. 40 to 46  show a compact catheter insertion apparatus including a catheter with side foldable wings and non-reversible protection fixation means of version embodiment, wherein: 
       FIG. 40  shows a side elevation of the apparatus in the transport position. 
       FIG. 41  shows a longitudinal section of the apparatus in the transport position. 
       FIGS. 42 ,  43  show cross sections of the apparatus in the transport position. 
       FIG. 44  shows a side elevation of the apparatus in the duty ready position with the section of the handle. 
       FIG. 45  shows a top plan view of the apparatus in the duty ready position. 
       FIG. 46  shows a longitudinal section of the apparatus in the protection position. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   A circumstantial explanation of the present invention is offered with reference made to the attached drawings. 
   The compact catheter insertion apparatus shown in  FIGS. 1 to 9  is comprised of: a needle unit  1  with a needle  2 , a needle distal sharp point  3  and a needle hub  4 , affixed to a proximal end of the needle  2 ; a catheter unit  5  with a catheter tube  6  and a catheter hub  7  affixed to a proximal end of the catheter tube  6 ; a handle  8 . 
   Mutual disposition of needle unit  1 , catheter unit  5  and handle  8  is determined with their transport position shown in  FIGS. 1 to 5 , duty ready position shown in  FIG. 6 , and protection position shown in  FIG. 9 . In the transport position needle  2  is housed inside catheter tube  6 , catheter unit  5  is disposed in the extreme proximal position with respect to handle  8  and needle distal sharp point  3  is protected against any contact ( FIG. 3 ). In the duty ready position, needle  2  is housed inside catheter tube  6  so that needle distal sharp point  3  protrudes distally outside of distal end  9  of catheter tube  6  and needle hub  4  is disposed in a distal extreme position with respect to handle  8  and removably fixed to it ( FIG. 6 ). In the protection position, needle unit  1  is separated from catheter unit  5  and retracted from the duty ready position in a proximal direction with respect to handle  8  so that needle distal sharp point  3  is positioned in security zone  10 , which is located at the distal part of handle  8  and protects needle distal sharp point  3  from any contacts with persons ( FIGS. 8 ,  9 ). 
   The apparatus also comprises: a protection fixation means for the fixation of needle unit  1  with respect to handle  8  in the transport and protection positions; a duty fixation means for the releasable fixation of needle unit  1  to handle  8  in the duty ready position; a transposing means for the transposition of catheter unit  5  and needle unit  1  from the transport position into the duty ready position; a limiting means for the prevention of needle unit  1  from excessive going out of handle  8  in a distal direction for the transposition of needle unit  1  to the duty ready position; a retracting means for the retraction of needle unit  1  from the duty ready position into the protection position; a trigger member for actuating the retracting means; a safety means for enhancing the reliability of the prevention of needle distal sharp point  3  in the protection position from going out of security zone  10  and from any contact with persons. 
   Noted retracting means includes resilient member  11  installed beyond a blood flow between hook members  12  of handle  8  and hook member  13  of needle unit  1 . Resilient member  11  interacts with handle  8  and needle unit  1  and has a minimal stressed state in the transport position (FIGS.  2 , 3 ) and the protection position ( FIGS. 8 ,  9 ) and a maximal stressed state in the duty ready position ( FIG. 6 ). This way, the deterioration of the resilient member elasticity for long storage of the apparatus in the transport position is avoided. It also allows an inexpensive, rubber resilient member to be used. Resilient member  11  is a rubber member, circular and solid in its cross section and made in form of a ring. Resilient member  11  is easily secured to needle unit  1  and handle  8  by means of hook members  12  and  13 . Resilient member  11  relates to the extension pulling members. Another feature of resilient member  11  is its eccentric disposition beyond the catheter unit in the transport position ( FIGS. 2 ,  3 ) that reduces the apparatus overall dimensions. 
   In version embodiments, the rubber resilient member is made: as a single linear member with a loop at each of its ends adapted to securing with the hook members similar to members  12 ,  13  and located on needle unit  1  and handle  8  (not shown); as a single linear member of solid or tubular cross section provided with an anchor member at each of its end and made as a local thickening adapted to securing with coupling means located on needle unit  1  and handle  8  (not shown). 
   The above noted transposing means includes transposing member  14 , which presents a member located on the lateral surface of needle hub  4  and adapted to the effect by user&#39;s finger to transpose needle unit  1  from the transport position to the duty ready position. 
   The above noted duty fixation means includes latch member  15  located on handle  8  and connected with its distal end  16  by elastic member  17  allowing to turn latch member  15  around elastic member  17 . Owing to the elasticity of elastic member  17 , latch member  15  is movable in a direction transverse relative to the axis of needle  2 . The duty fixation means also includes engagement member  18  located in recess  19  on the lateral surface of needle hub  4  and immovable relative to needle hub  4 . As a result of the transposition of needle unit  1  from the transport position into the duty ready position, latch member  15  and engagement member  18  engage ( FIG. 6 ) and thereby provide the fixation of needle unit  1  relative to handle  8  in the duty ready position. In this state, latch member  15  and engagement member  18  interact with each other by operating surface  20  of the latch member facing distally and operating surface  21  of the engagement member facing proximally. Due to its elastic properties, elastic member  17  also provides the keeping force, which, in the duty ready position, is directed towards the axis of needle hub  4 . Said keeping force provides the introduction of latch member  15  into the engagement with engagement member  18  and keeps them in the engaged state in the duty ready position. 
   Above noted trigger member  22  presents the extension of latch member  15  upwards ( FIGS. 1 to 8 ). Trigger member  22  in the duty ready position ( FIG. 6 ) is disposed at the distal end of handle  8  so that there is a possibility to control trigger member  22  by the same user&#39;s hand, which holds the apparatus at its handle  8 . Holding the apparatus in the duty ready position, the user introduces needle distal sharp point  3  into patient&#39;s vein and displaces catheter unit  5  relative to needle  2  in the distal direction as it is shown in  FIG. 7 . Then, user presses trigger member  22  in the proximal direction by a finger of the hand, which holds the apparatus. As a result, latch member  15  and engagement member  18  are disengaged and needle unit  1  under an effect of resilient member  11  is retracted automatically into the protection position shown in  FIG. 8 . Thus, user implements the apparatus control using only one hand and the retraction of needle unit  1  into the protection position is accomplished automatically. 
   The above noted protection fixation means includes resilient member  11 , which in the protection and transport positions prevents needle unit  1  from the displacement in a distal direction relative to handle  8 . It also includes a proximal protection fixation means preventing needle unit  1  in the transport and protection positions from the displacement in a proximal direction relative to the handle. This means comprises distal stopping member  23  presenting the proximal face of plug  24  of flash chamber  25  located in needle hub  4  and a proximal stopping member presenting the distal face  26  of proximal lid  27  of handle  8 . 
   The above noted limiting means contains distal limiting member  28  presenting the distal face of longitudinal slot  29  in handle  8  and proximal limiting member  30  presenting the proximal face of transposing member  14 . The limiting members abut against each other at the end of the transposition stroke preventing needle unit  1  from going out in a distal direction. 
   The above noted safety means presents distal lid  31  of handle  8 , which in the protection position is manually closed as it is shown in  FIG. 9 . Lid  31  relates to the safety limiting means restricting the mobility of the needle distal sharp point and the access to it with the restrictive barriers. Lid  31  as a distal barrier prevents the needle distal sharp point from going outside security zone  10  in a distal direction. 
   The apparatus shown in  FIGS. 1 to 9  has distal handle lid  31 , elastic link  17 , latch member  15 , trigger member  22 , limiting member  28 , and handle  8  made of plastics as a single unit. Moreover, needle hub  4 , transposing member  14 , engagement member  18 , hook member  13 , and limiting member  30  are made as a single unit. As a result, the construction of the apparatus consists of few relatively simple details leading to the apparatus low manufacturing cost. 
   Handle  8  of the apparatus presents an oblong body with internal cavity  32  of a circular cross section, which houses needle unit  1  and catheter unit  5  in the transport position, serves as a guide for needle hub  4 , and has longitudinal slot  29  for movable location and the transposition of transposing member  14 . 
     FIGS. 10 to 14  show the version embodiment of the compact catheter insertion apparatus, which has the same means and many identical details in comparison with the previous version. Therefore, these details have similar designations distinguished only by the addition of the numeral 100.The distinctions of said version embodiment are considered below. 
   Resilient member  111  relates to the compression pushing members and is made as a compression spiral spring axially disposed relative to needle  102 . Catheter hub  107  is disposed inside spring  111  in the transport position and spring  111  allows a free transposition of the catheter hub from the transport position to the duty ready position ( FIGS. 11 ,  13 ). 
   The duty fixation means includes oblong elastic cantilever arm  139  extending along the distal portion of handle  108  outside of it, connected with handle  108  by its distal end and having latch  115  on its proximal end and trigger member  122  on its middle portion. Trigger member  122  is made as the lug of arm  139  protruding in the direction opposite handle  108 . The duty fixation means also includes engagement member  118 , which is made as a single unit with transposing member  114  and located over arm  139  in the duty ready position ( FIG. 13 ). Cantilever arm  139  fulfils the keeping means role by creating the keeping force directed to the side opposite relative to handle  108  and, at the same time, cantilever arm  139  provides the mobility of latch  115  in the transverse direction owing to its elasticity. Latch member  115  and engagement member  118  have interacting surfaces  120  and  121  respectively. 
   The safety means of the apparatus, according to  FIGS. 10 to 14 , presents the safety locking means increasing the engagement between needle  102  and handle  108  and their mutual immobility in the protection position. This means includes the automatic locking members made as projection  137  on handle  108  and notch  138  on needle unit  101 , which become engaged in the transport and protection positions ( FIGS. 11 ,  14 ). These locking members have surfaces  133  and  134 , which interact during the introduction of projection  137  and notch  138  into engagement. Surfaces  133  and  134  are disposed at a relatively small angle, approximately 30°, to the axis of handle  108 . This provides a low resistance, surmountable by spring  111  during said introduction of locking members  137  and  138  into the engagement. Surfaces  135 ,  136  of locking members  137 ,  138  also interact during the disengagement of locking members  137 ,  138  during the transposition of the needle unit into the duty ready position. These surfaces are disposed at a relatively high angle, approximately 60°, to the axis of handle  108 . Therefore, they provide a relatively high, but manually surmountable, resistance during the disengagement of locking members  137 ,  138 . Said high resistance prevents needle distal sharp point  103  from accidentally existing security zone  110  in the transport and protection positions. 
   Note, that latch member  115 , trigger member  122 , cantilever arm  139 , distal limiting member  128 , locking member  137 , and handle  108  present a single unit. According to the fabrication technology, handle  108  is made as two part joined by seam  140 . Moreover, transposing member  114 , engagement member  118 , proximal limiting member  130 , locking member  138 , and needle unit  101  are made as a single unit. The minimization of details number results in low manufacturing cost. 
   The other means of the apparatus according to  FIGS. 10 to 14  are identical to the previous version. 
   The version embodiment of the apparatus shown in  FIGS. 15 to 20  has the designations of the details with the first numeral 2. The description of the previous version relates to the part of present version details with identical second and third numerals. At the same time, the present version has some distinctions, which are considered below. 
   Resilient member  211  presents a compression pushing member made as a compression spiral spring, disposed lengthwise of handle  208  eccentrically with respect to needle  202  and beyond catheter unit  205  in the transport position. The eccentric disposition results in a substantial decrease in the diameter of spring  211 , which, in the present version, constitutes approximately 18% of the handle  108  diameter. This creates new possibilities for the general arrangement of the apparatus details leading to the reduction of the apparatus size and manufacturing cost. It also facilitates the application of the catheter hub with a side port and side flexible wings. 
   The duty fixation means includes latch member  215 , which is disposed on needle hub  204  made in the form of elastic arm and has operating surface  220  facing proximally. This means also includes engagement member  218  with operating surface  221  facing distally. Operating surface  221  is located in longitudinal notch  247  at the distal portion of handle  208 . Said elastic arm also fulfils the keeping means role creating the keeping force directed from handle  208 . 
   The safety means presents the safety lock means comprising manually controlled locking arm  243  made as a single unit with trigger member  222 , disposed at the distal portion of handle  208  and connected with it by elastic link  217 . After the insertion of catheter unit  205  into the patient&#39;s vein ( FIG. 19 ), user turns locking arm  243  downward by trigger member  222  and thereby disengages latch member  215  and engagement member  218 . As a result, needle unit  201 , under the effect of spring  211 , is automatically retracted into the protection position ( FIG. 20 ). After that, user turns locking member  243  clockwise thereby pressing the needle  202  to the internal wall of handle  208  and ruling out any displacement of needle  202  relative to handle  208 . 
   Transposing member  214  is provided with elastic lateral plates  241  ( FIGS. 15 ,  16 ) interacting with stopping members  246 . Stopping members  246  have proximal inclined surfaces  245  ( FIG. 19 ) adapted to surmounting the stopping members  246  by lateral plates  241  during the introduction of needle unit  201  into handle  208  for their assembly. Stopping members  246  also have distal sheer surfaces  244 , which make stopping members  246  insurmountable by lateral plates  241  during the retraction of needle unit  201  into the protection position. The presence of stopping members  246  enables the exclusion of the proximal handle lid from the apparatus thereby reducing its total detail number and manufacturing cost. 
   The version embodiment of the apparatus according to  FIGS. 21 to 28  has the designations of the details with the first numeral 3. The description of the previous versions relates to the part of the present version details with identical second and third numerals. At the same time, the present version has some distinctions, which are considered below. 
   The retracting means includes rubber resilient member  311  akin to resilient member  11  in  FIGS. 1 to 9 . 
   Catheter hub  307  includes side port  350  and two flexible side wings  351  for fixing the catheter hub to the patient&#39;s skin. Internal cavity  332  of handle  308  has the form in its cross section ( FIGS. 24 ,  25 ) adapted to receiving catheter hub  307  with side port  350  and flexible side wings  351 . Specifically, handle  308  contains internal lateral guide grooves  349  for movable receiving guide ridges  355  of needle hub  304  and  356  of intermediate bush  348  (see as well  FIG. 21 ). Moreover, handle  308  has sufficiently broad elongated slot  329  for movable location and transposition of side port  350  and flexible side wings  351  inside it. 
   The duty fixation means includes engagement member  318  with operating surface  321  disposed on intermediate bush  348 , which is immovably connected with handle  308  in the duty ready position ( FIG. 26 ). The duty fixation means also includes lath member  315  with operating surface  320  disposed on one of two arms of lever  357 . The second arm of lever  357  presents trigger member  322 . Lever  357  is connected with needle hub  304  by elastic link  317 . In the transport position ( FIGS. 21 to 23 ), lath member  315  and engagement member  318  are engaged under the effect of the keeping force creating by elastic link  317  and stopping members  323  and  326  abut against each other under the effect of resilient member  311 . User transposes needle unit  301  into the duty ready position by means of transposing member  314 . Therewith, limiting members  328 ,  330  prevent needle unit  301  from excessive going out of handle  308  in a distal direction. In the duty ready position ( FIG. 26 ), notches  354  of intermediate bush  348 , shown in  FIG. 21 , come into the engagement with ridges  353  located on elastic plates  352  of handle  308 . As a result, the fixation of the intermediate bush relative to handle  308  is accomplished. User then displaces catheter unit  305  into the patient&#39;s vein ( FIG. 27 ) and then disengages latch member  315  and engagement member  318  by means of trigger member  322 . As a result, resilient member  311  retracts needle unit  301  into the protection position ( FIG. 28 ) and needle distal sharp point  303  enters security zone  310  located in intermediate bush  348 , which remains at the distal end of handle  308 . In this position, intermediate bush  348  presents the safety means restricting access to needle distal sharp point  303  and its radial movement due to the small diameter of intermediate bush  348 . 
   The version embodiment of the apparatus according to  FIGS. 29 to 39  has the designations of the details with the first numeral 4. The description of the previous versions mainly relates to the part of the present version details with identical second and third numerals. At the same time, the present version has specific distinctions, which are considered below. 
   The retracting means includes compression spring  411  located eccentrically with respect to the axis of needle  402  underneath of handle internal cavity  432  and connected with needle unit by connecting member  461  movably passing through lower slot  460 . 
   Catheter hub  407  includes the side port  450  and two foldable side wings  451  for fixing the catheter hub to the patient&#39;s skin. Internal cavity  432  of handle  408  has the form in its cross section adapted to receiving catheter hub  407  with side port  450  and folded side wings  451  ( FIG. 34 ). Specifically, handle  408  contains internal lateral guide grooves  449  for movable receiving the guide ridges  455  of intermediate member  448  and the guide ridges (not shown) of needle unit  401  located proximally of ridges  455 . Moreover, handle  408  has elongated slot  429  sufficiently broad for movable location and transposition of side port  450  and folded side wings  451  inside it. 
   The duty fixation means includes engagement member  418  in the form of a notch on needle unit  401  and lath member  415  disposed on lever  458 , which is connected with intermediate member  448  by elastic portion  417  ( FIGS. 31 ,  36 ,  37 ,  38 ). The upper portion of lever  458  fulfils a role of trigger member  422  designed for pressing on its distal side and simultaneously a role of transposing member  414  designed for pressing on its proximal side. In the transport position ( FIGS. 29-35 ), lath member  415  and engagement member  418  are engaged under the effect of the keeping force creating by elastic portion  417 , and stopping members  423  and  426  abut against each other under the effect of spring  411 . User transposes needle unit  401  into the duty ready position by means of transposing member  414 . Therewith, limiting members  428 ,  430  prevent needle unit  401  from excessive going out of handle  408  in a distal direction. In the duty ready position ( FIGS. 36 ,  37 ), notches  454  of intermediate member  448  come into the engagement with ridges  453  located on elastic plates  452  of handle  408 . As a result, the fixation of intermediate member  448  relative to handle  408  is accomplished. User then inserts catheter unit  405  into patient&#39;s vein ( FIG. 38 ) and, after this, disengages latch member  415  and engagement member  418  by means of trigger member  422 . As a result, spring  411  retracts needle unit  401  into protection position ( FIG. 39 ) and needle distal sharp point  403  enters security zone  410  located in intermediate member  448 , which remains at the distal end of handle  408 . Needle unit  401  is held in the protection position by spring  411  without any means allowing needle unit transposition in a distal direction from the protection position as its transposing member  414  has remained in the previous duty ready position. Thus, the embodiment of lever  458  and latch member  415  provides the disconnection of needle unit  401  and transposing member  414  during actuating trigger member  422  thereby converting the protection fixation means into non-reversible means, which eliminate the displacement of needle unit  401  relative to handle  408  in a distal direction from the protection position. 
   The version embodiment of the apparatus, according to  FIGS. 40 to 46 , has the designations of the details with the first numeral 5. The description of the previous versions mainly relates to the part of the present version details with identical second and third numerals. At the same time, the present version has specific distinctions, which are considered below. 
   The retracting means includes rubber resilient member  511  in the form of a ring located mainly inside handle  508  closely to its lower wall. In the transport position, resilient member  511  is disposed at the proximal end of handle  508  and its distal end is attached to needle hub  501  adjacently to the proximal end of catheter hub  507  ( FIG. 41 ). 
   The duty fixation means includes oblong elastic cantilever arm  539  extending along handle  508  over it, connected with needle unit  501  through longitudinal slot  529  in handle internal cavity  532 , and having latch  515  and trigger member  522  on its distal portion as well as transposing member  514  on its proximal end. The duty fixation means also includes engagement member  518 , which is made as a single unit with handle  508  and located at the distal portion of handle  508  over it. 
   Catheter hub  507  includes two foldable side wings  551  for fixing the catheter hub to the patient&#39;s skin. Handle internal cavity  532  is adapted to movable receiving catheter hub  507  with side wings  551 , which, in the transport position, are folded in a distal direction underneath catheter hub  507 . 
   User transposes needle unit  501  and catheter unit  505  into the duty ready position pressing onto transposing member  514 . In the duty ready position, latch  515  and engagement member  518  engage fixing the duty ready position, and side wings  551  go out of handle internal cavity  532  and straighten ( FIGS. 44 ,  45 ). After inserting catheter tube  506  into patient&#39;s vein, user presses down onto trigger member  522  thereby disengaging latch  515  and engagement member  518  and allowing resilient member  511  to retract needle unit  501  into protection position ( FIG. 46 ). 
   The protection fixation means of the apparatus presents a non-reversible means eliminating the displacement of needle unit relative to handle  508  in a distal direction from the protection position. This means includes the locking member in the form of projection  537  located on elastic portion  559  of the handle cavity internal wall and notch  538  on needle unit  501 . Projection  537  has inclined distal surface  533 , which is faced proximally and interacts with the proximal end of needle unit  501  in the transport position and during the retraction of needle unit  501  into the protection position. In the transport position, needle unit  501  is located distally of surface  533  because the force of resilient member  511  is insufficient to deflect elastic portion  559  and surmount surface  533  ( FIG. 41 ). During needle unit retraction into the protection position, the sum of resilient member force and needle unit inertia force is sufficient to surmount surface  533  by needle unit proximal end. As a result, projection  537  and notch  538  engage in the protection position ( FIG. 46 ). Projection  537  and notch  538  have proximal surfaces  535  and  536  inclined with respect to the needle axis at such angle, e. g. 90°, which eliminates their disengagement upon pushing needle unit  501  in a distal direction.

Technology Classification (CPC): 0