WO2017151052A1

WO2017151052A1 - Blood collection device

Info

Publication number: WO2017151052A1
Application number: PCT/SE2017/050202
Authority: WO
Inventors: Per Knutsson
Original assignee: Vigmed Ab
Priority date: 2016-03-04
Filing date: 2017-03-06
Publication date: 2017-09-08

Abstract

A blood collection device (1000) is disclosed. The blood collection device (1000) comprises a catheter hub (100), said catheter hub comprising: a tubular catheter (101) attached to a catheter hub body (102) at its proximal end; a catheter hub cavity (103) in fluid communication with the lumen of the tubular catheter (101); a tube (105) in fluid communication with the catheter hub cavity (103), said tube (105) extending laterally from the catheter hub body (102); a valve (106), proximally of the catheter hub cavity (103); and a drainage needle (112) arranged at an end of the tube (105), said needle being covered by a needle pierceable resealable multi-sample sleeve (109). The blood collection device (1000) also comprises a needle hub (200), said needle hub (200) comprising: an IV needle (201) extending distally from a needle hub body (202); and wherein the needle hub (200) is arranged in connection to the catheter hub (100), such that the needle (201) is slidingly arranged through said valve (106) and in the lumen of said catheter (101), such that the needle (201) may be withdrawn proximally from the catheter hub (100). A blood collection device (1000), wherein the dimensions of catheter (101) are selected such that the relationship between the length and the inner diameter of the catheter (101) is 0.18 to and 0.37 is also provided.

Description

BLOOD COLLECTION DEVICE TECHNICAL FIELD

The present invention pertains to a blood collection device, comprising a needle hub, a catheter hub with a catheter connected distally of an catheter body, said catheter body having an extension tube extending laterally from the catheter body, wherein the extension tube is in fluid communication with an inner catheter body cavity and the lumen of the catheter, and a needle shield assembly.

BACKGROUND

When collecting blood, needle assemblies are used for example together with evacuated tubes. The needle assemblies include a housing with a proximal end, a distal end, and a passage extending between the ends. Such needle assemblies further include at least one needle cannula mounted to the housing. The needle cannula includes a sharply pointed distal end that projects distally beyond the housing, a proximal end that projects proximally beyond the housing, and a lumen that provides communication between the opposed ends of the needle cannula. Some needle assemblies include separate proximal and distal cannulas and rely upon a portion of the housing to provide communication between the lumens of the respective cannulas. The distal end of the needle cannula typically is beveled to a tip that is sufficiently sharp for piercing the skin of the patient and accessing the vein or other source of fluid that is to be collected. The proximal end of the needle cannula is configured for piercing a rubber stopper on an evacuated tube. The proximal end of the needle cannula typically is covered by a needle pierceable resealable multi-sample sleeve. The sleeve is compressed by the rubber stopper of the evacuated tube and punctured by the proximal end of the needle cannula as the proximal end of the needle cannula is urged into communication with the evacuated tube. The evacuated tube is typically received by a needle holder secured to the proximal end of the housing. Prior to use, the needle assembly also typically includes an IV shield and a non-patient shield mounted respectively over the distal end of the needle cannula and the proximal end of the needle cannula. The IV shield and the non-patient shield are frictionally retained on the housing and can be separated through axial movement of the shields away from the housing. The combined needle assembly and evacuated tube is employed by initially urging the pointed distal end of the needle cannula into a blood vessel of a patient. Once the targeted blood vessel has been accessed, the evacuated tube is urged into the needle holder such that the proximal point of the needle cannula pierces the septum of the tube. Low pressure conditions within the evacuated tube, as well as the patient's own vasculature pressure, generate a flow of blood from the patient through the needle cannula and into the evacuated tube. The evacuated tube may be removed from the needle holder after a sufficient quantity of blood has been collected. One or more additional evacuated tubes may similarly be urged into the open end of the needle holder for drawing one or more additional samples of blood to be analyzed. The needle cannula is then withdrawn from the patient after a sufficient volume of blood has been collected for the required analytical procedure.

Many blood collection devices are provided with a flashback chamber that communicates with the needle cannula. The flashback chamber typically is formed at least partly from a transparent or translucent material and is intended to receive a portion of the blood flow shortly after a vein has been accessed properly. The flashback chamber gives a positive indication of venous entry after a vein is entered with the distal end of the needle cannula.

In order to reduce the risk of an accidental needle stick, or contact that could transmit pathogens from the patient to the medical practitioner, the needle cannula is shielded after contact with the patient. Shields have taken many different forms. For example, some shields telescope over the needle cannula and frictionally engage the housing. Other shields are telescoped over the housing and can be moved distally over the needle cannula to effect shielding. Other shields are hingedly mounted to or near the housing and can be rotated from an open position, where the needle cannula is exposed, to a closed position, where the needle cannula is shielded.

US20130237927 discloses a blood collection device of this kind, wherein the blood collection device includes a housing having proximal and distal ends, an IV cannula projecting distally from the housing, and an IV shield having an engagement. The housing has a shield seat and the IV cannula has a distal tip. The IV shield has a pre-use position where the IV shield covers the distal tip of the IV cannula and the engagement is disengaged from the shield seat, and a use position where the

engagement is engaged with the shield seat and the IV shield is adapted to move between a non-shielded position, in which the distal tip is exposed, and a shielded position, in which the distal tip is shielded by the IV shield. However, there is a risk of accidental needle stick when activating the IV shield, i.e. from the moment the distal IV cannula is removed from the vein of the patient and the IV shield has been moved into the shielded position, as well as a risk of accidental needle stick during the activation procedure of the IV shield. Additionally, it is often received as unpleasant and inconvenient to have a needle in the vein of the patient though out the blood collection procedure. The patient cannot move freely when having a needle cannula in his/her vein.

Hence, there is a need of a blood collection device overcoming these drawbacks.

SUMMARY

It is an object of the present invention, considering the disadvantages mentioned above, to provide a blood collection device mitigating and alleviating these drawbacks. For these purposes, a blood collection device comprises: a catheter hub, said catheter hub comprising: a tubular catheter attached to a catheter hub body at its proximal end; a catheter hub cavity in fluid communication with the lumen of the tubular catheter; a tube in fluid communication with the catheter hub cavity, said tube extending laterally from the catheter hub body; a valve, proximally of the catheter hub cavity; and a drainage needle arranged at an end of the tube, said needle being covered by a needle pierceable resealable multi-sample sleeve; a needle hub, said needle hub comprising: an IV needle extending distally from a needle hub body; and wherein the needle hub is arranged in connection to the catheter hub, such that the needle is slidingly arranged through said valve and in the lumen of said catheter, such that the needle may be withdrawn proximally from the catheter hub.

Alternatively, or in combination, for these purposes a blood collection device comprises: a catheter hub, said catheter hub comprising: a tubular catheter attached to a catheter hub body at its proximal end; a catheter hub cavity in fluid communication with the lumen of the tubular catheter; a tube in fluid communication with the catheter hub cavity, said tube extending laterally from the catheter hub body; and a valve, proximally of the catheter hub cavity, wherein the dimensions of catheter are selected such that the relationship between the length and the inner diameter of the catheter is 0.18 to and 0.37; a needle hub, said needle hub comprising: an IV needle extending distally from a needle hub body; and wherein the needle hub is arranged in connection to the catheter hub, such that the needle is slidingly arranged through said valve and in the lumen of said catheter, such that the needle may be withdrawn proximally from the catheter hub.

Further features of the invention and its embodiments are set forth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which the invention is capable will be apparent and elucidated from the following description of non-limiting embodiments of the present invention, reference being made to the accompanying drawings, in which

Fig. 1A is a perspective view of a blood collection device according to one embodiment of the present invention;

Fig. IB is a side view of the blood collection device in Fig. 1A;

Fig. 1C is a top and cross- sectional view of the blood collection device in Fig. 1A showing a partially exploded view of the valve arrangement in the device when the needle is in the cathether;

Fig. 2A is a perspective view of a blood collection device according to another embodiment of the present invention;

Fig. 2B is a side view of the blood collection device in Fig. 2A;

Fig. 2C is a top and cross- sectional view of the blood collection device in Fig. 2A showing a partially exploded view of the valve arrangement in the device when the needle is in the cathether;

Fig. 2D is a partially exploded and cross- sectional view of an another valve arrangement when the needle is in the catheter that may be used in the blood collection devices of the present invention;

Fig. 2E is a partially exploded and cross-sectional view of an alternative valve arrangement when the needle is in the catheter that may be used in the blood collection devices of the present invention;

Fig. 3A is a perspective view of a blood collection device according to an alternative embodiment of the present invention;

Fig. 3B is a side view of the blood collection device in Fig. 3A;

Fig. 3C is a top view of the blood collection device in Fig. 3A; Fig. 3D is a side view of the blood collection device in Fig. 3A with the needle withdrawn from the catheter;

Fig. 3E is a top and cross- sectional view of the blood collection device in Fig. 3A showing a partially exploded view of the valve arrangement in the device when the needle is withdrawn from the catheter;

Fig. 4 A is a perspective view of a blood collection device according to yet another embodiment of the present invention with the needle withdrawn from the catheter;

Fig. 4B is a side view of the blood collection device in Fig. 4A;

Fig. 4C is a top and cross- sectional view of the blood collection device in Fig.

4A showing a partially exploded view of the valve arrangement in the device;

Fig. 4D is a partially exploded and cross- sectional view of the valve

arrangement shown in Fig. 2E after the needle has been withdrawn from the catheter and the valve has closed;

Fig. 4E is a partially exploded and cross-sectional view of the valve

arrangement shown in Fig. 2D after the needle has been withdrawn from the catheter and the valve has closed;

Fig. 4F is a perspective view of the blood collection device in Fig. 4A with the needle withdrawn from the catheter hub and showing a partially exploded view of a needle shield protecting the tip of the needle; and

Fig. 4G is a perspective view of the device in Fig. 4F without the needle and having a plug in the proximal end of the catheter hub.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Embodiments of the present invention will be described in more detail below with reference to the accompanying drawings in order for those skilled in the art to be able to carry out the invention. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

Furthermore, the terminology used in the detailed description of the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. More specifically, the term "proximal" refers to a location or direction of items or parts of items, during normal use of the blood collection device disclosed herein, is closest to the user, i.e. the clinician, and farthest away from the patient receiving the blood collection device. Similarly, the term "distal" refers to a location or direction of items or parts of items, during normal use of the blood collection device disclosed herein, is closest to the patient and farthest away from the clinician. The term "laterally" refers to the direction away from the central axis of the blood collection device, such that at least a vector component perpendicular to the central axis of the blood collection device, wherein a needle and catheter of the assembled blood collection device coincides with the central axis of the blood collection device.

Up to this point, only needles have been used for blood collection. Catheter systems have not been used. Standardized IV catheter systems cannot fulfill the blood collection procedure standards. The pressure drop over the standardized catheter dimensions, does not give a satisfactory filling of the evacuated tubes - not with regard to volume and nor with regard to time. The parameters of importance, in relation to pressure drop, are catheter length and the inner diameter of the catheter. Also, open IV catheter systems are very unsuitable for the obvious reason that blood will start leaking proximally right after insertion of the IV catheter into the vein, making the blood collection procedure very cumbersome if not impossible. The present inventor has realized what measures to be taken to with regard to adapting a catheter system suitable for blood collection.

Four blood collection devices 1000, 2000, 3000, and 4000 are illustrated in figures 1-4. Devices 1000 and 2000 have no evacuated tube holder 400 unlike devices 3000 and 4000. Devices 1000 and 4000 utilize a plug 500 unlike devices 2000 and 3000. Apart from these differences the four blood collection devices retain common features and thus the same reference numerals are used to identify the common features in the four blood collection devices 1000, 2000, 3000, and 4000.

In accordance with Fig. 1 A-C, one embodiment of a catheter hub 100 of a blood collection device 1000 is illustrated. The catheter hub 100 comprises a longitudinal and tubular catheter 101 at its distal end. The catheter is, in accordance with above, intended to be inserted into a blood vessel of a patient. The catheter 101 is attached to a catheter hub body 102 at its proximal end, such that the catheter extends distally from the catheter hub body 102. The lumen of the catheter 101 is in fluid communication with a catheter hub cavity 103. The catheter hub body 102 is preferably made through injection molding, and then of a rigid plastic material suitable for injection molding and connection and interaction with other parts of the system. Such a suitable material is polycarbonate or a copolymer of polycarbonate and polyester. The catheter may be of a polyolefin polymer, such as polyethylene and polypropylene (medical grades of these). Since the catheter 101 of this blood collection device 1000 does not need to be in the vein for time periods equal to intravenous infusion systems, polyolefins may be used for the catheter 101. The catheter 101 may however also be of another material, such as polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), and polyurethane (PUR). To comply with the pressure drop characteristics and to obtain a standardized filling of the evacuated tube, the dimensions of the catheter 101 are selected such that the relationship between the length and the inner diameter of the catheter 101 is 0.18 to and 0.37. The length of the catheter is selected to be below 20 mm, such as from 15 to 19 mm, and the inner diameter is selected to be 0.35 to 0.65 mm.

From the catheter hub body 102 a tube connector 104 is provided. The tube connector 104 extends laterally from the catheter hub body 102. The tube connector 104 has a lumen in fluid communication with the hub cavity 103, such that a tube 105 may be connected to the tube connector 104 to allow for infusion from the tube 105 into the tube connector 104, further into hub cavity 103 to catheter 101, and finally into the blood stream of the patient. The tube connector 104 may for example be tubular. A suitable material for the tube 105 is polyvinyl chloride or ethylene vinyl acetate.

The catheter hub cavity 103 ends proximally in a valve 106 as shown in Fig.

1C. This valve 106 has a central through channel, through which a needle 201 of a needle hub 200 may run, in accordance with Fig. 1C. When the needle 201 has been withdrawn from the catheter hub 100, the valve 106 will close said through channel, such that the hub cavity 103 is marked off from the surroundings in the proximal direction. For this reason, the valve 106 is preferably of a suitable rubber material or silicone. For allowing for a preferred withdrawal force of the needle hub 200 from the catheter hub, i.e. with a friction low enough for convenient withdrawal, the valve 106 may have different configurations, in accordance with Figs. 2C to 2E. These configurations allow for a low frictional withdrawal force, while realizing a satisfactory sealing effect with regard to hindering blood from flowing proximally past the valve 106. In contrast to closed IV catheter systems, having wide rubber septum, incurring high frictional force when withdrawing the needle hub 200 from the catheter hub 100, for ensuring that nothing can enter the blood stream through being infused through the septum, these demands are not present when collecting blood, since then nothing is to be infused into the blood stream but instead collected there from. In Fig. 2C the valve 106 is a duckbill valve 106b. The duckbill valve 106b is preferably a rubber duckbill valve 106b. The duckbill valve 106b has a tubular and cylindrical body 1061b, intended to be fitted flush with and inside the catheter hub body 102. At the distal end of the tubular and cylindrical body 1061b, the valve wall 1062b is tapered into engaging sealing lips 1063b. When pressure on the distal side of the duckbill valve 106b increases, due to blood flow, the tapered engaging sealing lips 1063b are pressed together, preventing backflow.

In Fig. 2D the valve 106 is a valve 106c with a U-shaped longitudinal cross- section, so called U-shaped valve 106c. The U-shaped valve 106c is preferably a rubber U-shaped valve 106c. The U-shaped valve 106c has a tubular and cylindrical body 1061c, intended to be fitted flush with and inside the catheter hub body 102. At the distal end of the tubular and cylindrical body 1061c, a transversal wall section 1062c is provided. The transversal wall section 1062c has a through hole for the needle 201 to pass through. As shown in Fig. 4E, when the needle 201 is withdrawn from the catheter 101, the through hole in transversal wall section 1062c closes to separate catheter hub cavity 103 from proximal end cavity 107.

In Fig. 2E the valve 106 is a porous plug valve 106d. The plug valve 106d is made of a liquid absorbent material, such as regenerated cellulose with or without reinforcing cotton fibers, or other polymers, suitable to form such absorbent porous structures. As shown in Fig. 4D, when the needle 201 is withdrawn from the catheter 101, the porous plug valve 106d closes to separate catheter hub cavity 103 from proximal end cavity 107.

On the proximal side of the valve 106 a proximal end cavity 107 is located. The end cavity 107 is formed by the tubular wall of the catheter hub body 102 and a distal end wall in the form of the proximal end wall of the septum 114. This end cavity 107, extending distally into the catheter hub body 102, is adapted in size and shape to house the needle shield 300, as disclosed in Fig. 1C.

The needle shield 300 is thus intended to be arranged on the needle 201 of the needle hub 200, which in turn is intended to be arranged in the catheter hub 100. In such assembled state, in accordance with Fig. 1C, the needle 201 penetrates the valve 106, and extends through the catheter 101. Preferably, the needle 201 extends just beyond the distal end of the catheter 101, such that skin and blood vessel penetration is facilitated. In that position, the needle shield 300 is arranged in the end cavity 107, with arms 301 thereof forced laterally by needle 201. The needle shield 300 preferably does not extend proximally of the proximal end of the catheter hub 100, but is instead entirely housed in the end cavity 107 of the catheter hub 100. In this way, the needle hub body 202 of the needle hub 200 may cooperate with the catheter hub body 102 of the catheter hub 100, without intermediary structures, such as the needle shield 300. This may be

accomplished through a distal connective flange 203 on the needle hub 200. The distal connective flange 203 may then house the proximal end of the catheter body 102 of the catheter hub 100. This connection may be a snap fit. Alternatively, the needle hub body

202 has a distal cavity for housing a part of the needle shield 300, while still being adapted to be connectable to the catheter hub body 102. In this position the needle shield 300 is held in place in the proximal end cavity 107 through interaction between a needle shield base plate 302 and the inner tubular wall of the catheter hub body 102. This may be accomplished by tongues 303, extending laterally of the base plate 302, being flexed somewhat inwardly to exercise a lateral pressure on the inner tubular wall of the catheter hub body 102 inside the end cavity 107. To further increase the cooperation between the periphery of the needle shield 300 and the catheter hub 100 a circumferential ridge 108 may be formed at the opening of the end cavity 107. The base plate 302 is provided with a centrally arranged through hole, such that the needle 200 may run freely therein.

When withdrawing the needle hub 200 from the catheter hub 100, after the catheter 101 has been securely placed inside the blood vessel of the patient, the needle hub 200 will firstly be disconnected from the cooperation between the catheter hub body 102 and the needle hub body 202, such as through release of the connective flange

203 from the circumference of the catheter body 102. Then the needle 201 travels proximally within the catheter 101, until the needle tip of the needle 201 exits the catheter 101 and enters the catheter hub body 102. When entering the catheter hub body 102, the needle tip of the needle 201 will continue proximally into the catheter hub cavity 103 and further through the valve 106. While the needle tip of the needle 201 travels proximally through the valve 106, the valve 106 will continuously seal off the catheter hub cavity 103 from the surroundings in the proximal direction. When the needle tip of the needle 201 exits the valve 106 on the proximal side thereof, the needle tip of the needle 201 enters the proximal end cavity 107 of the catheter hub 100, wherein the needle shield 300 is positioned and is securingly interacting with the inner tubular wall of the catheter hub body 102. When the needle tip of the needle 201 passes proximally of the arms 301, the arms 301 will snap centrally to cover the needle tip of the needle 200. This may be further facilitated by hooked tips 304 on the arms 301. Just subsequently to the snapping of the arms 301 in front of the tip of the needle 201, a bulge 204 on the needle 201 hits the base plate 302. The bulge 204 has a width that is greater than the central lumen of the base plate 302. Thus, the withdrawal of the needle hub 200 further proximally will pull out the needle shield 300 from the end cavity 107. This is accomplished by adapting the retaining action from tongues 303, such that the retaining force from these is overcome by a suitable withdrawal force. Then the needle hub is separated from the catheter hub, and the needle shield 300 is securely arranged on the tip of the needle 200 to prohibit and prevent accidental needle stick.

Distally of the bulge 204 a notch 207 may be provided. The notch 207 penetrates the wall of the needle 201, to provide a through hole in the wall of the needle 201. In assembled state the notch 207 is positioned underneath the catheter 101. When penetrating the vein of the patient, blood will pass through the notch 207 to indicate that the needle 201 indeed is positioned correctly inside a vein - i.e. that the lumen of the needle 201 is positioned correctly inside the vein - such that blood may be withdrawn.

The needle shield 300 may comprise one, two, three or more tongues 303, which extend proximally from the lateral circular periphery of the base plate 302. The tongues 303 are, in accordance with above, resilient, whereby they are resiliency striving from a compressed state towards an expanded state. In the assembled state within the end cavity 107, the tongues 303 are somewhat compressed, to exercise a force on the inner walls of the catheter hub 100. The needle shield 300 is thereby held therein, i.e. a constant spatial relationship between the needle shield 300 and the catheter hub 100 is provided. A plurality of tongues 303 may be evenly spread at the periphery of the base plate 302, whereby each tongue 303 is contacting the inner surface of the catheter hub 100 with essentially the same force.

The tongues 303 may comprise a protuberance 305 extending in a direction essentially perpendicular to the central axis or laterally of the needle shield 300. When the tongues 303 are provided with protuberances 305, the diameter of the base plate 302 in a transversal plane intersecting the protuberances 305 may be greater than the diameter of the end cavity 107, and specifically the proximal opening thereof, along a transversal plane. Then the needle shield 300 may be compressed, due to the flexibility of the tongues 303, such that it may be inserted into the end cavity 107 in a compressed state. In the inserted position, the protuberances 305 on the tongues 303 then exerts a retaining radially outwards directed pressure on the inner wall of the end cavity 107. The ridge 108 at the opening of the end cavity 107 then maintains the needle shield 300 within the cavity, until the needle 201 pulls the needle shield proximally, whereby the pressure of the protuberances 305 on the inner walls of the end cavity 107 is overcome and the also the protuberances 305 are pressed inwardly beyond the ridge 108 to release the needle shield 300 from the end cavity 107. To facilitate interaction between the needle shield 300 and the end cavity 107, the ridge 108 is somewhat slanting distally and/or proximally. The protuberances 305 are in the same way slanting distally and/or proximally. Preferably the slanting of the protuberances is sharper in the proximal direction than in the distal direction, whereby the needle shield 300 may be smoothly inserted into the end cavity 107, retained with a snap action when the proximal side of the protuberances pass distally beyond the ridge 108, and also maintained more securely due to the sharper slanting at the proximal zone.

According to one embodiment, the needle shield 300 may be made of a plastic material. Preferably, the plastic material has a suitable combination, for its intended purpose, of tenacity, rigidity, fatigue resistance, elasticity, and creep deformation resistance. A suitable plastic material has a high creep deformation resistance, i.e. it has a low tendency to slowly move or deform permanently under the influence of an applied external pressure. Hence, a catheter system of the present invention, comprising needle shield 300, may be stored in the assembled ready mode for a prolonged time without extensive creep deformation of the arms 301 or the tongues 303. Advantages of a plastic needle shield 300 include the highly reduced tendency, in comparison to metal, of release of e.g. microscopic plastic chips by the scraping of the plastic catheter hub 100, when the needle shield 300, is ejected from the former upon withdrawal of the needle 201. Accordingly, the tendency for formation of scrape marks, which may result in leakage through the affected connector, is greatly reduced. In addition, a plastic needle tip shielding device may be easily color coded or transparent, depending on its particular application.

The needle shield 300 is a monolithic or homogenous injection molded needle shielding 300, made of a molded plastic material. Due to the specific configuration of the different parts of the needle shield 300 according to the embodiments of the present invention, the needle shield 300 may be molded, such as injection molded, into one homogenous, i.e. monolithic, piece and/or one integral unit, without interfaces in between the different parts thereof. Advantages of a monolithic needle shield 300 include a lower production cost in comparison to other devices made of more than one part that has to be assembled. The needle shield 300 may in this respect be made of a thermoplastic polymer. The thermoplastic polymer could be crystalline, amorphous, or comprising crystalline and amorphous alternating regions. A creep resistance of the thermoplastic polymer of choice may preferably be at least 1200 MPa (ISO 527, ASTM D638). Suitable plastics for the needle shield 300 may be selected from the group comprising of polyoxymethylene (POM), polybutylen terephthalate (PBTP), polymethyl methacrylate (PMMA), acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN), acrylonitrile styrene acrylate (ASA), polystyrene (PS), styrene butadiene (SB), liquid crystal polymer (LCP), polyamide (PA), polysulfone (PSU), polyetherimide (PEI), polycarbonate (PC), polyphenylene oxide (PPO), and/or PPO/SB, and co- and terpolymers thereof. These polymers have specifically the advantages of providing enhanced storing capacity, even in strained state, and excellent cooperation abilities with regard to the catheter hub, due to the excellent structure memory of these polymers.

Contacting smooth shapes of two bodies, such as a needle shield 300 mounted in a catheter hub 100, may result in a significant attraction between these bodies, especially if the contact area is large and they are pressed together. The underlying basis for this type of attraction include intermolecular attraction between the molecules of the two bodies, in which molecular van der Waals interactions and surface tension of the two bodies are important factors. Covalent bond formation between closely interacting surfaces may also contribute to the attraction. Such covalent bond formation, and other types of attraction between two surfaces, may also result upon radiation treatment, such as radiation treatment of e.g. catheter instrument to sterilize these. This type of attraction may become noticeable when the needle shield 300 is about to be released from the catheter hub 100. The force needed to release the needle shield 300 from the catheter hub 100 then becomes significantly higher than expected. This effect, which may be referred to as "the attraction effect", may even adventure the intended function of the needle tip shielding device if relying on e.g. an automatic release of a part of the device, such as a spring biased arm or the like, from a part of the catheter hub. The needle shield 300 is kept in contact with the catheter hub 100 in the assembled state via at least one interface surface between the needle shield 300 and the catheter hub 100. Thus, in one embodiment the surface of the needle shield 300 being in contact with the inner lumen of the catheter hub is of a different polymeric material than the polymeric material of the catheter hub.

At the other end of the tube 105 a drainage needle 112 is arranged, for communicating with an evacuated tube in a known manner. The drainage needle 112 is covered by a needle pierceable resealable multi-sample sleeve 109. The sleeve 109 is preferably formed from a material that is substantially impervious to liquid, such as blood, readily pierceable by the needle tip of the drainage needle 112, and resiliency resealable. The sleeve 109 is adapted to collapse distally upon being engaged by a rubber stopper on an evacuated tube. Preferably, the sleeve 109 is made of rubber. The drainage needle 112 with sleeve 109 may be arranged at the other end of the tube 105 via a needle adapter 110, such as a drainage needle hub 110, which in turn is connected to the tube 105 via a standard Luer slip® or Luer lok® connection 113.

Centrally of the drainage needle 112 the tube 105 or needle adapter 110, such as the drainage needle hub 110, is provided with a thread 111. As shown in Fig. 3E, the thread 111 is adapted for receiving a corresponding female thread 401 of an evacuated tube holder 400 in a known manner.

To facilitate insertion of the needle 201 and attachment of the catheter hub 100 to the skin of the patient, the catheter hub 100 is provided with first and second wings 115 and 116. Wings 115 and 116 extend laterally in opposite directions from the catheter hub 100. The thickness of the wings 115, 116 is selected to be below 0.50 mm, such from 0.15 to 0.35 mm, to provide flexibility. The wings 115, 116 may be provided with one or more longitudinal grooves 117, in which groove the wings 115, 116 have a thickness below 0.50 mm, such from 0.15 to 0.35 mm. The groove or grooves assist in flexibility and folding of the wings 115, 116. The wings 115, 116 and catheter hub 100 may be manufactured as one monolithic body, for example through injection molding these parts together.

Grips 205 and 206 are provided in opposing positions on the needle hub 200.

Grips 205 and 206 allow easier grasping of the needle hub 200 and withdrawal of the needle 201 through the catheter 101.

In use, the nurse or physician inserts the catheter 101 into the vein of the patient. After insertion of the catheter 101, the needle hub 200, with needle 201, is withdrawn proximally from the catheter hub 100. When withdrawing the needle hub

200 from the catheter hub, the needle will pass through the valve 106, and thereafter the bulge 204 on the needle will bring with it the needle shield 300, now covering the needle tip, in accordance with what has been described above. A plug 500 may then be inserted at the proximal end cavity 107. As shown in Figs. 1A and 4 A, the plug 500 may have been positioned at the proximal end of the needle hub 200 prior to insertion of the catheter into the vein and withdrawal of the needle hub 200. The plug 500 may be provided with a tapered sealing surface 501 shown in Figs. 1C and 4C. In this way the same plug may be securely connected to the needle hub 200 prior to insertion of the catheter 101, whilst simultaneously allowing for secure closure of the proximal end cavity 107. The evacuated tube holder 400 may have been connected centrally of the drainage needle 112 prior to insertion of the catheter 101 into the vein or the evacuated tube holder 400 is connected centrally of the drainage needle 112 after the catheter 101 has been inserted. After this, an evacuated tube is pressed onto the drainage needle 112, to press the sleeve 109 centrally, whereby the low pressure in the evacuated tube will facilitate filling the tube with blood in standardized manner.

In the claims, the term "comprises/comprising" does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. The terms "a", "an", "first", "second" etc do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

1. A blood collection device (1000) comprising:

a catheter hub (100), said catheter hub comprising: a tubular catheter (101) attached to a catheter hub body (102) at its proximal end; a catheter hub cavity (103) in fluid communication with the lumen of the tubular catheter (101); a tube (105) in fluid communication with the catheter hub cavity (103), said tube (105) extending laterally from the catheter hub body (102); a valve (106), proximally of the catheter hub cavity (103); and a drainage needle (112) arranged at an end of the tube (105), said needle being covered by a needle pierceable resealable multi-sample sleeve (109);

a needle hub (200), said needle hub (200) comprising: an IV needle (201) extending distally from a needle hub body (202); and

wherein the needle hub (200) is arranged in connection to the catheter hub (100), such that the needle (201) is slidingly arranged through said valve (106) and in the lumen of said catheter (101), such that the needle (201) may be withdrawn proximally from the catheter hub (100).

2. The blood collection device (1000) according to claim 1, wherein the dimensions of catheter (101) are selected such that the relationship between the length and the inner diameter of the catheter (101) is 0.18 to and 0.37.

3. The blood collection device (1000) according to claim 1 or 2, wherein the length of the catheter (101) is selected to be below 20 mm, such as from 15 to 19 mm.

4. The blood collection device (1000) according to any of the preceding claims, wherein the inner diameter of the catheter (101) is selected to be 0.35 to 0.65 mm.

5. The blood collection device (1000) according to any of the preceding claims, wherein the catheter (101) comprises a polyolefin polymer.

6. The blood collection device (1000) according to any of the preceding claims, wherein the catheter hub (100) comprises a tube connector (104) extending laterally from the catheter hub body (102), and the tube (105) in turn is attached to the tube connector (104).

7. The blood collection device (1000) according to any of the preceding claims, wherein the valve (106) is made of silicone or rubber.

8. The blood collection device (1000) according to any of the preceding claims, further comprising a needle shield (300), said needle shield (300) comprising: at least one resilient arm (301) extending distally from a base plate (302), said base plate (302) having a through hole for receiving the needle (201) there through;

wherein said IV needle (201) has a bulge (204) at its distal end zone;

wherein the needle shield (300) is arranged in an end cavity (107), proximally of the valve (106), in a retained manner through cooperation between the needle shield (300) and an inner wall of the catheter hub (100) in said end cavity (107), and onto the needle (201), such that the at least one arm (301) rests upon and is spring loaded by the needle (201), and the needle (201) is slidingly arranged within the through hole of the base plate (302), in an assembled state; and

wherein the bulge (204) will interact with the base plate (302) when the needle hub (200) is withdrawn from the catheter hub (100) to withdraw the needle shield (300) from the catheter hub (100) and the at least one arm (301) will cover the tip of the needle (201), in a released state.

9. The blood collection device (1000) according to any claim 8, wherein the needle shield (300) cooperates with the inner wall of the catheter hub body (102) in the end cavity (107) through the periphery of the base plate (302).

10. The blood collection device (1000) according to claim 9, wherein the periphery of the base plate (302) is provided with at least one resilient tongue (303), which in turn cooperates with the catheter hub body (102).

11. The blood collection device (1000) according to any of claims 8 to 10, wherein the needle shield (300) is a monolithic plastic body.

12. The blood collection device (1000) according to claim 11, wherein the plastic material of the needle shield (300) is selected from the group consisting of POM, PBTP, PMMA, ABS, SAN, ASA, PS, SB, LCP, PA, PSU, PEI, PC, PPO, and/or PPO/SB.

13. A blood collection device (1000) comprising:

a catheter hub (100), said catheter hub comprising: a tubular catheter (101) attached to a catheter hub body (102) at its proximal end; a catheter hub cavity (103) in fluid communication with the lumen of the tubular catheter (101); a tube (105) in fluid communication with the catheter hub cavity (103), said tube (105) extending laterally from the catheter hub body (102); and a valve (106), proximally of the catheter hub cavity (103), wherein the dimensions of catheter (101) are selected such that the relationship between the length and the inner diameter of the catheter (101) is 0.18 to and 0.37;

14. The blood collection device (1000) according to claim 13, further comprising a needle shield (300), said needle shield (300) comprising: at least one resilient arm (301) extending distally from a base plate (302), said base plate (302) having a through hole for receiving the needle (201) there through;

wherein said IV needle (201) has a bulge (204) at its distal end zone;

15. The blood collection device (1000) according to any of the preceding claims, wherein the valve (106) is a duckbill valve (106b).

16. The blood collection device (1000) according to any of claims 1 to 14, wherein the valve (106) is a valve (106c) with a U-shaped longitudinal cross-section.

17. The blood collection device (1000) according to any of claims 1 to 14, wherein the valve (106) is a plug valve (106d) comprising a porous liquid absorbent material.