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WO2017151052A1 - Dispositif de prélèvement sanguin - Google Patents

Dispositif de prélèvement sanguin Download PDF

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Publication number
WO2017151052A1
WO2017151052A1 PCT/SE2017/050202 SE2017050202W WO2017151052A1 WO 2017151052 A1 WO2017151052 A1 WO 2017151052A1 SE 2017050202 W SE2017050202 W SE 2017050202W WO 2017151052 A1 WO2017151052 A1 WO 2017151052A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
catheter
hub
catheter hub
blood collection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SE2017/050202
Other languages
English (en)
Inventor
Per Knutsson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vigmed AB
Original Assignee
Vigmed AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vigmed AB filed Critical Vigmed AB
Publication of WO2017151052A1 publication Critical patent/WO2017151052A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A61B5/150641—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/15074—Needle sets comprising wings, e.g. butterfly type, for ease of handling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; Blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings or valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape

Definitions

  • 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.
  • the needle assemblies 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.
  • the needle assembly 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Fig. 4D is a partially exploded and cross- sectional view of the valve
  • Fig. 4E is a partially exploded and cross-sectional view of the valve
  • 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;
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a catheter hub 100 of a blood collection device 1000 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.
  • 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).
  • PTFE polytetrafluoroethylene
  • FEP fluorinated ethylene propylene
  • PUR polyurethane
  • 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.
  • a tube connector 104 is provided from the catheter hub body 102 .
  • 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.
  • valve 106 has a central through channel, through which a needle 201 of a needle hub 200 may run, in accordance with Fig. 1C.
  • the valve 106 will close said through channel, such that the hub cavity 103 is marked off from the surroundings in the proximal direction.
  • the valve 106 is preferably of a suitable rubber material or silicone.
  • the valve 106 may have different configurations, in accordance with Figs. 2C to 2E.
  • 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.
  • 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.
  • a transversal wall section 1062c is provided at the distal end of the tubular and cylindrical body 1061c.
  • 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.
  • 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.
  • a liquid absorbent material such as regenerated cellulose with or without reinforcing cotton fibers, or other polymers, suitable to form such absorbent porous structures.
  • the porous plug valve 106d closes to separate catheter hub cavity 103 from proximal end cavity 107.
  • a proximal end cavity 107 is located on the proximal side of the valve 106 .
  • 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.
  • the needle 201 penetrates the valve 106, and extends through the catheter 101.
  • the needle 201 extends just beyond the distal end of the catheter 101, such that skin and blood vessel penetration is facilitated.
  • 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.
  • 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
  • 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.
  • the needle shield 300 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.
  • 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.
  • 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.
  • the needle hub 200 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
  • 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.
  • 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.
  • the needle tip of the needle 201 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.
  • the arms 301 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.
  • 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.
  • 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.
  • the notch 207 is positioned underneath the catheter 101.
  • 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.
  • 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.
  • 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.
  • the ridge 108 is somewhat slanting distally and/or proximally.
  • the protuberances 305 are in the same way slanting distally and/or proximally.
  • 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.
  • the needle shield 300 may be made of a plastic material.
  • 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.
  • 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.
  • 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.
  • POM polyoxymethylene
  • PBTP polybutylen terephthalate
  • PMMA polymethyl meth
  • 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.
  • 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.
  • 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.
  • 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.
  • the tube 105 or needle adapter 110 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.
  • 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.
  • 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
  • a plug 500 may then be inserted at the proximal end cavity 107.
  • 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.

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Abstract

L'invention concerne un dispositif de prélèvement sanguin (1000). Le dispositif de prélèvement sanguin (1000) comprend une embase de cathéter (100), ladite embase de cathéter comprenant : un cathéter tubulaire (101) fixé à un corps d'embase de cathéter (102) au niveau de son extrémité proximale ; une cavité d'embase de cathéter (103) en communication fluidique avec la lumière du cathéter tubulaire (101) ; un tube (105) en communication fluidique avec la cavité de l'embase de cathéter (103), ledit tube (105) s'étendant latéralement à partir du corps d'embase de cathéter (102) ; une valve (106), dans la direction proximale de la cavité de l'embase de cathéter (103) ; et une aiguille de drainage (112) disposée à une extrémité du tube (105), ladite aiguille étant couverte par un manchon multi-échantillon refermable et apte à être percé par une aiguille. Le dispositif de prélèvement sanguin (1000) comprend également une embase d'aiguille (200), ladite embase d'aiguille (200) comprenant : une aiguille IV (201) s'étendant de manière distale à partir d'un corps d'embase d'aiguille (202) ; et l'embase d'aiguille (200) étant disposée en connexion avec l'embase de cathéter (100), de telle sorte que l'aiguille (201) est disposée de manière coulissante à travers ladite valve (106) et dans la lumière dudit cathéter (101), de telle sorte que l'aiguille (201) peut être retirée de manière proximale de l'embase de cathéter (100). L'invention concerne également un dispositif de prélèvement sanguin (1000), les dimensions du cathéter (101) étant choisies de telle sorte que le rapport entre la longueur et le diamètre interne du cathéter (101) est de 0,18 à 0,37.
PCT/SE2017/050202 2016-03-04 2017-03-06 Dispositif de prélèvement sanguin Ceased WO2017151052A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE1650290-8 2016-03-04
SE1650290 2016-03-04

Publications (1)

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WO2017151052A1 true WO2017151052A1 (fr) 2017-09-08

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Cited By (4)

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Publication number Priority date Publication date Assignee Title
US20200139088A1 (en) * 2017-03-24 2020-05-07 Poly Medicure Limited Fluid administration medical apparatus and intravenous catheter assembly
CN111971084A (zh) * 2018-01-31 2020-11-20 史密斯医疗Asd公司 可释放的安全导管插入组件
CN113952591A (zh) * 2020-07-20 2022-01-21 贝克顿·迪金森公司 脉管通路器械和相关装置及方法
CN114762603A (zh) * 2021-01-15 2022-07-19 贝克顿·迪金森公司 抽血组件以及相关装置和方法

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US20050043709A1 (en) * 2002-10-10 2005-02-24 Brimhall Greg L. System and method of delivering local anesthesia
EP1602329A1 (fr) * 2004-06-02 2005-12-07 Becton, Dickinson and Company Ensemble de collecte de sang avec mécanisme d'aération
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Publication number Priority date Publication date Assignee Title
US20200139088A1 (en) * 2017-03-24 2020-05-07 Poly Medicure Limited Fluid administration medical apparatus and intravenous catheter assembly
US11524145B2 (en) * 2017-03-24 2022-12-13 Poly Medicure Limited Fluid administration medical apparatus and intravenous catheter assembly
CN111971084A (zh) * 2018-01-31 2020-11-20 史密斯医疗Asd公司 可释放的安全导管插入组件
EP3746168A4 (fr) * 2018-01-31 2022-03-02 Smiths Medical ASD, Inc. Ensemble d'insertion de cathéter de sécurité libérable
CN113952591A (zh) * 2020-07-20 2022-01-21 贝克顿·迪金森公司 脉管通路器械和相关装置及方法
CN114762603A (zh) * 2021-01-15 2022-07-19 贝克顿·迪金森公司 抽血组件以及相关装置和方法
US20220225913A1 (en) * 2021-01-15 2022-07-21 Becton, Dickinson And Company Blood Draw Assembly and Related Devices and Methods

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