WO2002080997A2

WO2002080997A2 - Safety venipuncture apparatus

Info

Publication number: WO2002080997A2
Application number: PCT/IL2002/000274
Authority: WO
Inventors: Sergey Popov
Original assignee: Serpomed Ltd.
Priority date: 2001-04-04
Filing date: 2002-04-02
Publication date: 2002-10-17
Also published as: WO2002080997A3; AU2002255233A1; IL142445A0

Abstract

This invention relates to medical venipuncture devices for hemodialysis, blood collection, etc. (see fig. 14). The device includes a hollow needle (35) movably located inside a tubular plastic protector (32). In the state ready for venipuncture, a needle sharp point (37) is extended distally of a protector's distal end. The user inserts the needle (36) and the protector into patient's vein and by a transposing means single-handedly displaces the protector for a short distance into the operation position, wherein the needle sharp point is concealed inside the protector eliminating the vein's injury and, subsequently, personnel's infection by the needle. A lock means disposed beyond blood flow automatically and reliably fix the device in this position. The needle and protector form a common blood passageway without vortices and clot formation. The device is provided with a sealing member (51) eliminating a blood leakage. The device features short length convenient for operation.

Description

SAFETY VENIPUNCTURE APPARATUS

Background of the Invention

1. Field of the Invention

The present invention relates to medical venipuncture devices for infusing medicine or biological fluid, hemodialysis, and donor blood collection.

2. Description of the Prior Art

Known venipuncture devices include a catheter unit consisting of a plastic catheter and a catheter hub as well as a needle unit containing a needle and a needle hub. The needle, which has a distal sharp point and an inner passageway, is housed inside the catheter and introduces the catheter inside the patient's vein. Fluids are then infused or collected via the needle's lumen. The needle hub is provided with a coupling means for connection to hemodialysis apparatus, blood collection set, infusion set etc.

U.S. Patent No. 3662754 discloses Injection Apparatus including a hollow needle with a distal sharp point and a needle hub having a coupling means. There is also a short catheter ("a protective sleeve" in Patent 3662754) telescoped over a distal portion of the needle and connected with a pusher by a thin drawbar, which is slidably located in a longitudinal guide groove in the needle wall. After inserting the needle distal sharp point into the patient's vein, the user displaces the catheter into the vein's lumen thereby protecting the vein from injury by the needle distal sharp point. The disadvantages of this apparatus are considered below.

The connection of the catheter and its pusher by the thin drawbar located in the guide groove of the needle wall is expensive and substantially complicates the manufacturing process. Moreover, the guide groove presents a passageway for blood leakage from the blood vessel. The design of the catheter hub does not allow single-handed control of the apparatus. Also, there exists the possibility of detaching the catheter disposed in the bloodstream from the needle leading to blood vessel embolism. After complete insertion of the short catheter into the vein, blood leakage between the needle and a vein opening is possible because the vein opening, previously broadened by the catheter, has a larger diameter than the needle. This is especially relevant to hemodialysis with inherent in it relatively high blood pressure. The discrepancy between the diameters of the catheter and the needle can also lead to vein injury by the proximal catheter edge during the withdrawal of the catheter from the vein. The above mentioned risk of blood leakage and the vein injury is heightened further by the thick catheter wall at the site of the drawbar attachment. Moreover, the absence of any locking means for a catheter fixation on the needle creates the possibility of proximal displacement of the catheter relative to the needle. As a result, the possibility of baring the needle distal sharp point in the vein arises and, as a consequence, vein injury.

U.S. Patent 4160450 discloses the Outside-the-needle Catheter Device with needle housing. The device includes a catheter with a catheter hub liquid-tightly connected with a hollow housing. There are two versions of said housing - the rigid and the collapsible. The device also, includes a needle and a needle hub, which is provided with a distal shank attached to a coupling means. The needle hub is disposed within the hollow housing and its shank extends proximally beyond this housing. In the rigid version of the housing, there is a liquid- tight slidable connection between the shank and the proximal face wall of the housing. In the collapsible version of the housing, this connection is immovable. The needle is housed within the catheter and extends beyond its distal end during insertion of the catheter into the vein. The needle is retracted into the housing cavity for device operation, for instance for hemodialysis. The disadvantages of this device are considered below.

After inserting the catheter into the vein, it is necessary to completely retract the needle from the catheter into the hollow housing. This long retraction stroke significantly worsens the device's ergonomics. This also necessitates a long hollow housing increasing the device material consumption and manufacturing cost. Moreover, the tightness of the slidable connection between the needle hub shank and the hollow housing in the rigid housing version must be provided throughout the entire long stroke of the needle retraction. This requires precise details fabrication, which raises manufacturing cost. In the collapsible housing version, the long flexible housing is awkward to fabricate and assemble. The rate of blood flow is significantly reduced in the internal cavity of the hollow housing increasing the danger of blood clot formation. Moreover, the disturbance of blood laminar flow in the zones of the catheter outlet and the needle inlet can lead to blood cell's injury, i. e. to impairment of blood quality. After withdrawal of the catheter from the patient's vein, there is a probability of relatively large blood leaking from the device. This relates, to a greater extent, to the collapsible housing version because accidental press onto its flexible housing causes abundant blood ejection. As a result, the risk of medical personnel infection arises. The device with the rigid housing contains a locking means in the form of a springy ring located inside the hollow housing cavity. This disposition of the locking means complicates the device's assembly and causes a local vortex motion of the blood worsening the blood quality. The device has many ergonomics disadvantages. Specifically, it is impossible to transpose the catheter into the extended position using one hand. It is inconvenient to hold the device with the collapsible housing during transposing the catheter into the extension position. There are certain problems of attaching the device to the patient's skin due to the device's large size. Another disadvantage of the device with the collapsible housing is the presence of air within the housing before venipuncture. This air can enter the blood stream causing embolism.

U.S. Patent 5370623 discloses Catheter with Protective Cover and Method of Catheterization. The device includes a needle with a distal sharp point and a needle hub. The device also includes a catheter and a catheter hub. The catheter encircles the needle and has two positions. In the first position, the needle distal sharp point is extended distally beyond the distal catheter end, and in the second position, the catheter is extended distally and covers the needle distal sharp point. There is a manually controlled bayonet-type locking means for mutual fixation of the catheter unit and the needle unit. The transposition of the catheter from the first position into the second position is actuated by a spring mounted between the needle and catheter hubs therewith the needle hub serves as a handle. Disadvantages of the devise are described in the following.

The fabrication and assembly of the device's details are substantially complicated due to the presence of the bayonet type locking means. The transposition of the catheter into the second (extended) position cannot be accomplished using one hand. The lock means is not automatic and, therefore, its actuation entirely depends on the user attentiveness. The likelihood of blood leaking out of the device arises due to the absence of a sealing means between the catheter and needle hubs. The most significant disadvantage is the use of the needle hub as a handle during transposing the catheter into the extended position by the spring. Since this transposition is very quick and directed to the patient's vein, it can lead to vein injury.

Thus, general disadvantages of the prior art devices are: insufficient safety for patients and medical personnel, relatively low level of ergonomics, particularly due to the impossibility of manipulating the device using one hand, some impairment of blood quality and the danger of blood clot formation, the complexity of details fabrication and assembly as well as high material consumption leading to increased manufacturing cost, the blood leakages, insufficient reliability, and the inconvenience of attaching these devices to the patient's skin.

Summary of the Invention

The objective of the present invention is to provide a safe venipuncture apparatus eliminating the possibilities of patient traumatization and medical personnel infection.

Another objective is to eliminate blood leakage from the apparatus.

Another objective is to improve the apparatus ergonomics, particularly by its single- handed control.

Another objective is to eliminate a blood impairment and blood clot formation during a blood passage through the apparatus.

Another objective is to decrease the complexity of the device's fabrication and assembly as well as its size and material consumption.

Another objective is to provide a high apparatus reliability.

Another objective is to provide an apparatus, which conveniently attaches to the patient's skin.

The above noted objectives of the present invention are accomplished with a safety venipuncture apparatus having: a protective unit with a tubular plastic protector and a protector hub; a needle unit including a tubular needle with a distal shaφ point and a needle hub; a longitudinal through passageway for fluid passage; a needle extended position and a protector extended position; the needle distal sharp point disposed within the protector in the protector extended position; a transposing means for converting the protective and needle units from the needle extended position into the protector extended position using one hand; an automatic lock means disposed beyond a blood flow and designed for the mutual fixation of the protective and needle units in the protector extended position; a sealing means mounted between the protective unit and needle unit at the distal side of the needle hub, beyond the longitudinal through passageway and made as a separate member having a slidable contact with one of two sealed members; a handle. There are two versions of the apparatus: in the first one, the handle and the protector hub are made as a single unit, and in the second one, the handle and the needle unit are made as a single unit. The first version includes the transposing means, which operates automatically by means of a spring after actuating the trigger. The second version has the transposing means, which is driven manually by a propelling means disposed on the protector hub.

The above noted novel lock means reduces the risk of the patient's vein injury by the needle distal shaφ point as it reliably keeps the needle inside the protector in the protector extended position. It does not demand the user attentiveness, does not lead to blood vortex, and simplifies the device's fabrication and assembly. As a result, safety and reliability of the apparatus are enhanced, blood quality is improved, and the manufacturing costs are reduced.

The above noted novel sealing means eliminates blood leakage during venipuncture and reduces the need for high precision of fabrication.

The above noted disposition of the needle distal shaφ point within the protector in the protector extended position significantly shortens the stroke of the needle and protector units transposition into the protector extended position. This, along with the described sealing means, enables the application of above noted transposing means with single- handed control. The short transposing stroke and the transposing means with single-handed control significantly increase the convenience of using the apparatus and enhance the apparatus ergonomics. Moreover, this short stroke allows the device overall length to be shortened leading to reduced material consumption and manufacturing cost as well as more convenient securing the apparatus to the patient's skin. The disposition of the needle distal shaφ point within the protector eliminates the large volumes, significant dimension changes, and air pocket's formation in the longitudinal through passageway. As a result, blood vortex, clot formation, and air entry the vein are avoided. The absence of the large volume in the passageway also eliminates the significant blood leakage after venipuncture. Thus, blood impairment is eliminated and medical personnel's and patient's safeties are assured. In the version where the distal shaφ point is located inside the protector proximal part within the range of the protector hub, additional safety is achieved due to the great rigidity of the needle distal shaφ point guard.

Operation of the handle and protector hub as a single unit in combination with the springy automatic transposing means enables convenient operation without the danger of vein injury.

Brief Description of the Drawings FIG. 1 to 5 show a safety venipuncture apparatus including the handle and the protector hub made as a single unit, the automatic transposing means with the spring and the trigger member as well as the latch and catch members for the mutual fixation of the protective and needle units in the needle extended position, wherein:

FIG. 1 shows a side view of the apparatus in the needle extended position.

FIG. 2 shows a top plane view of the apparatus in the needle extended position.

FIG. 3 shows a longitudinal section of the apparatus in the needle extended position.

FIG. 4 shows a cross section of the apparatus in the needle extended position.

FIG. 5 shows a longitudinal section of the apparatus in the protector extended position.

FIG. 6 to 16 show the safety venipuncture apparatus including the handle and the needle hub made as a single unit, the propelling means disposed on the upper part of the protector hub and protruding upwards through the handle upper longitudinal slot, wherein:

FIG. 6 shows a side view of the apparatus in the needle extended position.

FIG. 7 shows a top plan view of the apparatus in the needle extended position.

FIG. 8 shows a longitudinal section of the apparatus in the needle extended position.

FIG. 9, 10, 11 show cross sections of the apparatus in the needle extended position.

FIG. 12 shows a side view of the apparatus in the protector extended position.

FIG. 13 shows a top plan view of the apparatus in the protector extended position.

FIG. 14 shows a longitudinal section of the apparatus in the protector extended position.

FIG. 15 shows a front view of the apparatus.

FIG. 16 shows a cross section of the apparatus in the protector extended position.

FIG. 17 to 23 show the safety venipuncture apparatus including the handle and the needle hub made as a single unit, the needle hub joined with the handle by the dam passing through the lower longitudinal slot in the protector hub, propelling means disposed on the protector hub, wherein:

FIG.17 shows a side view of the apparatus in the needle extended position.

FIG. 18 shows a top plan view of the apparatus in the needle extended position.

FIG. 19 shows a longitudinal section of the apparatus in the needle extended position.

FIG. 20 shows a cross section of the apparatus in the needle extended position.

FIG. 21 shows a side view of the apparatus in the protector extended position.

FIG. 22 shows a top plan view of the apparatus in the protector extended position.

FIG. 23 shows a longitudinal section of the apparatus in the protector extended position. Detailed Description of the Invention

An explanation of the present invention is offered with reference made to the attached drawings.

The safety venipuncture apparatus shown in FIG. 1 to 5 comprises: a protective unit 31 having a tubular protector 32 and a protector hub 33 connected with a protector proximal end 34 so that the protector proximal end 34 is disposed within the protector hub 33; a needle unit 35 including a tubular needle 36 with a distal shaφ point 37 and a needle hub

38 affixed to proximal end of the needle 36; a longitudinal through passageway 39 for passing a liquid; a handle 40 designed for holding the apparatus by user an made as a single unit with the protector hub 33. Mutual dispositions of the protective unit 31 and the needle unit 35 are determined with the needle extended position, shown in FIG. 1 to 4, and the protector extended position, shown in FIG. 5. In the needle extended position, the needle 36 is housed substantially inside the protector 32 so that the needle distal shaφ point 37 is extended distally beyond a protector distal end 41 and the longitudinal through passageway

39 is formed entirely by the needle unit 35. After introducing the protector 32 into the patient's vein, the user converts the apparatus into the protector extended position. In the protector extended position, the needle 36 is housed inside the protective unit 31 and the protector 32 is extended distally so that the protector distal end 41 is disposed more distally than the needle distal sharp point 37 preventing the needle distal shaφ point 37 from a contact with the patient's vein. In this position, the longitudinal through passageway 39 is formed with the protective unit 31 and the needle unit 35 in common.

In the protector extended position shown in FIG. 5, the needle distal shaφ point 37 is located inside the part of the protector 32, which is disposed beyond the protector hub 33 from its distal side. This location allows the very short stroke during the transposition of the needle unit 35 and the protective unit 33 from the needle extended position into the protector extended position. As a consequence, the length, material consumption, and manufacturing cost of the apparatus are reduced. Moreover, the apparatus length decrease facilitates securing the apparatus to the patient's skin as well as creates conveniences for other operations. In version embodiment (not shown), the needle distal shaφ point is located inside of the protector part, which is disposed within the protector hub. In this version, the enhanced safety is achieved due to the high rigidity of the needle shaφ point guard. Therewith, there is some decreasing the advantages of the previous version. The noted mutual disposition of the distal shaφ point 37 and the protector 32 in the protector extended position, in both versions, eliminates large blood volumes and significant dimension changes in the longitudinal trough passageway 39. This prevents a blood vortex and blood clots formation, getting air into the patient's vein as well as increased blood flow out of the apparatus after the venipuncture. As a result, the blood impairment eliminates and medical personnel's and patient's safety increases.

The apparatus has a transposing means for the transposition of the protective unit 31 and the needle unit 35 from the needle extended position into the protector extended position. The transposing means comprises: a spring 43 installed between the protector hub 33 and the needle hub 38 and stressed in the needle extended position; a latch member 44 movably mounted in the handle 40 and the catch member 45 made as a recess in the needle hub 38. The latch member 44 and the catch member 45 engage in the needle extended position fixing the mutual disposition of the protective unit 31 and needle unit 35. There is also a trigger member 46, which, after actuating by the user, disengages the latch 44 and the catch 45 members releasing the spring 43. As a result, the spring 43 transposes the needle unit 35 relative to the protective unit 31 from the needle extended position into the protector extended position. The arrangement of the handle 40 and the trigger member 46 allows the control of the trigger member 46 by the single user hand, which holds the apparatus at the handle 40. This improves the apparatus ergonomics. The combination of the springy automatic transposing means and the handle 40, made as a single unit with the protector hub 33, provides the transposing movement in the opposite direction relative to the patient's vein. This eliminates the danger to the patient's vein injury by the protector distal end 41 during the transposition of the units 31, 35 into the protector extended position. It should be noted, that the material of the protector 32, which is made of non-hard flexible plastic, also facilitates the prevention of the vein from injury.

The apparatus also comprises an automatic lock means including the first engagement member 47 located on the protector hub 33 and the second engagement member 48 in the form of a notch located on the needle hub 38. Both engagement members 47 and 48 are disposed beyond blood flow and engage automatically at the end of the transposition of the units 31 and 38 from the needle extended position into the protector extended position. As a result of this engagement, the needle unit 35 is prevented from the displacement distally relative to the protective unit 31 in the protector extended position. There is a limiting means including the first limiting member 49 located on the needle unit 35 and the second limiting member 50 located on the protective unit 31. In the protector extended position, the limiting members 49 and 50 abut against each other preventing the needle unit 35 from the displacement proximally relative to the protective unit 31. Thus, the locking and limiting means provide reliable mutual fixation of the protective 31 and needle 35 units in the protector extended position. This automatic lock means eliminates an accidental exit of the needle distal shaφ point 37 from the protector 32 into the patient's vein and vein's injury during a medical procedure and provides the independence of locking the units 31, 35 of the user's attentiveness. Moreover, the arrangement of the lock means beyond a blood flow eliminates the blood vortex and simplifies the apparatus assembly.

The apparatus comprises a sealing means made as a separate sealing member 51 and mounted beyond the longitudinal through passageway 39, from the distal side of the needle hub 38, between the protector hub 33 and the needle 36. The sealing member 51 has a slidable sealed contact with the needle 36, provides the liquid- tightness of the gaps between the protective unit 31 and needle unit 35, and eliminates a blood leakage to the outside of the apparatus during the venipuncture. This sealing means decreases the requirements to a fabrication precision in comparison with the prior art.

The apparatus is provided with the coupling means 52 located at the proximal end of the needle hub 38 and adapted to the connection with a blood collection set, hemodialysis apparatus etc.

The apparatus fabrication technology provides for assembling the protector hub 33 of the proximal 53 and distal 54 parts and joining them in the zone of the seam 55 with a supeφosition of lateral plates 40A and 40B, as it is shown in FIG. 4.

The version embodiment of the apparatus according to FIG. 6 to 16, has its details' designations beginning with the first numeral "1". The description of the previous version relates to the part of the present version details with identical two last numerals. At the same time, the present version has certain distinctions, which are considered in the following.

The apparatus handle 140 and the needle hub 138 are made as a single unit. The transposing means includes a propelling means with the projection 156, which is located on the protector hub 133 and actuated by the single user's hand holding the apparatus at the handle 140. The upper plate 157 of the protector unit 131 also can be used as a propelling means. The handle 140 has a distally disposed longitudinal cavity 158 with inner walls 159 (see FIG. 14, 15, 8, 9). The cavity 158 movably houses the protector hub 133, which serves as a guide for the handle 140 and the needle unit 135 during their transposition into the protector extended position. The cavity 158 has an upper longitudinal slot with inner lateral walls 161 (see FIG. 9). The upper part 160 of the protector hub 133 (see FIG. 9, 16) with the propelling means 156, 157 disposed on it passes through this upper longitudinal slot and slightly protrudes upwards outside of the handle 140. After introducing the needle distal shaφ point 137 and the protector distal end 141 into the patient's vein, the user displaces the protector 132 deeper into the patient's vein pushing the projection 156 and using the needle 136 as a guide for the protector 132. The user then manually transposes the protective unit 131 and the needle unit 135 into the protector extended position using the propelling means. At the end of this transposing stroke, the mutual disposition of the protective unit 131 and the needle unit 135 is fixed by the engagement members 147, 148 of the lock means and the limiting members 149, 150 of the limiting means. With the exception of the described distinctions in the transposing means, the present and the previous versions have the same means and advantages.

The version embodiment of the apparatus according to FIG. 17 to 23 has its details' designations beginning with the first numeral "2". The description of the previous versions relates to the part of the present version details with identical two last numerals. At the same time, the present version has certain distinctions, which are considered in the following.

The apparatus handle 240 and the needle hub 238 are made as a single unit. The transposing means includes the propelling means made as the projection 256 and the finned surface 257 located on the protector hub 233 and activated by the user's hand, which holds the apparatus. Thus, the transposing means enables a single-handed control. The protector hub 233 has a proximally disposed longitudinal cavity 263 with inner walls 264 and a lower longitudinal slot 267 with inner walls 265 (see FIG. 19, 20, 23). The cavity 263 movably houses the needle hub 238 and serves as a guide for the needle hub 238 during its transposition into the protector extended position. The handle 240 is joined with the needle hub 238 by a dam 266 passing through the lower longitudinal slot 267 (see FIG. 20). After introducing the needle distal shaφ point 237 and the protector distal end 241 into the patient's vein, the protector 232 is inserted deeper into the patient's vein by pushing the propelling means 256, 257 and using the needle 236 as a guide for the protector 232 while the needle unit 235 is affixed to the patient's skin by means of the finned surface 262. The user then transposes the needle unit 235 and the protective unit 231 into the protector extended position by advancing the propelling means 256, 257. At the end of this transposition, the engagement members 248 located on the protector hub 233 engage with the engagement members 247 located on the handle 240 preventing the needle unit 235 from the displacement distally relative to the protective unit 231 in the protector extended position. At the same time, the limiting members 250 on the protector hub 233 and 249 on the handle 240 prevent the needle unit 235 from the displacement proximally relative to the protective unit 231. Thus, the lock means and the limiting means reliably fix the units 231 and 235 in the protector extended position. With the exception of the described distinctions of the transposing, limiting, and lock means, the present and previous versions have the same details, means, and advantages.

A few combinations, used in the present invention, are considered in the following.

The combination of the sealing means 51 (see FIG. 1 to 5) and the apparatus's single- handed control is novel. The sealing means 51 eliminates the blood leakage from the apparatus during the venipuncture and excludes thereby the restriction of the free user's hand arrangement on the apparatus. Specifically, the sealing means obviates the necessity of the apparatus lengthening to displace proximally the zone of probable blood leakage from the gap between the shank 52 and the proximal face of the protector hub 33 in order to avoid the getting blood onto the user's hand. As a result, the material consumption and the manufacturing cost reducing, as an additional advantage, are achieved.

The combination of the automatic lock means 147, 148 (see, for instance, FIG. 14) and the apparatus's single-handed control is novel. The automatic lock means obviates the necessity of any user's actions for the fixation of the mutual disposition of the needle unit 135 and the protective unit 131 in the protector extended position. This creates the conditions for the single-handed control of the apparatus.

The combination of the needle distal shaφ point 137 disposed within the protector 132 in the protector extended position and the sealing means 151 is novel (see FIG. 14). The noted mutual disposition of the needle distal shaφ point 137 and the protector 132 significantly shortens the stroke needed to transpose the needle unit 135 relative to the protective unit 131 into the protector extended position. As a result, the expenses for the sealing means are significantly reduced. This results in reducing the apparatus manufacturing cost. Thus, the noted combination enables substantial reducing the apparatus manufacturing cost as an additional advantage. The combination of the handle 240 made as a single unit with the needle hub 238 and the needle distal shaφ point 237 disposed within the protector 232 in the protector extended position is novel (see FIG. 22, 23). This handle performance necessitates the manually driven transposing means to avoid the trauma of the patient's vein by the protector distal end 241. However, this manual drive can be sufficiently convenient only upon relatively short transposing stroke, which is obtained due to the noted disposition of the needle distal shaφ point. Thus, these two features are mutually stipulated in the combination, which provides the high safety and ergonomics of the apparatus.

Claims

Claims:

1. A safety venipuncture apparatus, comprising:

• a protective unit having: a tubular protector and a protector hub connected with a proximal end of said protector so that said protector proximal end is disposed within the limits of said protector hub;

• a needle unit including: a tubular needle with a distal shaφ point and a needle hub affixed to a proximal end of said needle;

• a longitudinal through passageway for passing a liquid;

• mutual disposition of said protective unit and needle unit are determined with a needle extended position and a protector extended position, wherein: in said needle extended position said needle is housed substantially inside said protector so that said needle distal shaφ point is extended distally beyond a distal end of said protector; and said longitudinal through passageway is formed by said needle unit;

> in said protector extended position said needle is housed inside said protective unit and said protector is extended distally so that said protector distal end is disposed more distally than said needle distal shaφ point; and said longitudinal through passageway is formed by said protective unit and said needle unit in common;

• a transposing means for the change of mutual disposition of said protective unit and needle unit from said needle extended position into said protector extended position by a single user's hand holding the apparatus;

• a lock means disposed beyond blood flow and designed for mutual fixation of said protective unit and needle unit in said protector extended position so that said mutual fixation prevents said needle unit from displacement distally relative to said protective unit;

• a limiting means designed for the prevention of said needle unit from the displacement proximally relative to said protective unit in said protector extended position;

• a handle designed for holding the apparatus by user during venipuncture and for transposition of said needle unit and protective unit from said needle extended position into said protector extended position;

• a sealing means disposed between the members of said protective unit and needle unit beyond said longitudinal through passageway to provide a liquid-tightness of the gaps between said units and to eliminate a blood leakage to the outside of the apparatus.

2. The apparatus of claim 1, wherein said lock means is made as an automatic lock means comprising two engagement members one of which is located on said protector hub and the other on said needle hub so that said engagement members engage automatically at the end of the transposition of said protective unit and needle unit from said needle extended position into said protector extended position and prevent said needle unit from the displacement distally relative to said protective unit in said protector extended position.

3. The apparatus of claim 1, wherein said limiting means presents two limiting members one of which is located on said protective unit and the other on said needle unit so that in said protector extended position said limiting members abut against each other thereby preventing the displacement of said needle unit proximally relative to said protective unit.

4. The apparatus of claim 1, wherein said sealing means presents a separate sealing member mounted at the distal side of said needle hub and having a slidable contact with one of two sealed members.

5. The apparatus of claim 4, wherein said sealing member is mounted between said protector hub and said needle hub.

6. The apparatus of claim 4, wherein said sealing member is mounted between said protector hub and said needle.

7. The apparatus of claim 1, wherein there is a coupling means located at the proximal end of said needle hub and adapted to the connection of the apparatus with a blood collection set, hemodialysis apparatus etc.

8. The apparatus of claim 1, wherein said handle and said protector hub are made as a single unit.

9. The apparatus of claim 8, wherein said transposing means includes: a spring installed between said protector hub and said needle hub and stressed in said needle extended position; a latch member movably mounted in said handle; a catch member located on said needle hub for an engagement with said latch member in said needle extended position and thereby fixing the mutual disposition of said protective unit and said needle unit in said needle extended position; a trigger member for the disengagement of said latch member an catch member resulting in releasing said spring and transposing said protective unit and said needle unit from said needle extended position into said protector extended position by said spring; and the arrangement of said handle and said trigger member allowing the user to hold the apparatus and to control said trigger member single-handedly.

10. The apparatus of claim 1, wherein said handle and said needle unit are made as a single unit.

11. The apparatus of claim 10, wherein said transposing means includes a propelling means located on said protector hub and made as at least one projection adapted to the actuation by the same user's hand, which holds the apparatus.

12. The apparatus of claim 11, wherein said handle has a distally disposed longitudinal cavity and an upper longitudinal slot, therewith said handle cavity movably houses said protector hub, which serves as a guide for said handle and said needle unit during their transposition into said protector extended position, and an upper part of said protector hub with disposed on it said propelling means passes through said upper longitudinal slot and slightly protrudes upward outside of said handle.

13. The apparatus of claim 11, wherein said protector hub has a proximally disposed longitudinal cavity and a lower longitudinal slot, therewith said protector hub cavity movably houses said needle hub and serves as a guide for said needle hub during its transposition into said protector extended position and said handle is joined with said needle hub by a dam passing through said lower longitudinal slot.

14. The apparatus of claim 1, wherein said needle distal shaφ point is located within said protector.

15. The apparatus of claim 14, wherein said needle distal shaφ point is located inside of the part of said protector, which is disposed beyond said protector hub from its distal side.

16. The apparatus of claim 14, wherein said needle distal shaφ point is located inside of the part of said protector, which is disposed within said protector hub.

17. The apparatus of claim 1, wherein said tubular protector is made of plastic.

18. A safety venipuncture apparatus, comprising:

• a longitudinal through passageway for fluid passage;

• mutual disposition of said protective unit and needle unit are determined with a needle extended position and a protector extended position, wherein:

> in said needle extended position said needle is housed substantially inside said protector so that said needle distal shaφ point is extended distally beyond a distal end of said protector; and said longitudinal through passageway is formed by said needle unit; in said protector extended position said needle is housed inside said protective unit and said protector is extended distally so that said protector distal end is disposed more distally than said needle distal shaφ point; and said longitudinal through passageway is formed by said protective unit and said needle unit in common;

• said needle distal shaφ point is disposed within said protector in said protector extended position;

• a transposing means for the change of mutual disposition of said protective unit and needle unit from said needle extended position into said protector extended position;

• a handle designed for holding the apparatus during venipuncture and transposition of said needle unit and protective unit from said needle extended position into said protector extended position; said handle and said needle hub are made as a single unit.

19. A safety venipuncture apparatus, comprising:

• a longitudinal through passageway for fluid passage;

• a transposing means for the change of mutual disposition of said protective unit and needle unit from said needle extended position into said protector extended position; • a handle designed for holding the apparatus during venipuncture and transposition of said needle unit and protective unit from said needle extended position into said protector extended position;

• a sealing means disposed between the members of said protective unit and needle unit beyond said longitudinal through passageway to provide a liquid-tight seal between said units and to eliminate a blood leakage to the outside of the apparatus;

• said sealing means presents a separate sealing member mounted from the distal side of said needle hub and having a slidable contact with one of two sealed members.

20. The apparatus of claim 19, wherein said sealing member is mounted between said protector hub and said needle hub.