DE20320905U1 - Backstroke needle arrangement for taking a blood or fluid sample has a chamber with at least a visualization area and a screen from opening or closing the canula - Google Patents

Abstract

Needle arrangement has a housing with proximal and distal ends and a chamber wall that defines a chamber within the housing. At least a transparent area of the housing wall permits observation of the fluid or liquid flowing into the chamber. Connected to the chamber is an intravenous canula that has a screen that can be used to open or close the canula.

Description

Background of the invention 1 , Field of the invention

A shieldable blood collection or removal needle or cannula assembly with a flashback or reset or flashback chamber to give a confirmation of the venous Entry.

2. Description of the related technology

Needle assemblies are used to collect samples of fluid, eg, blood, from a patient. Some such needle assemblies are intended for use with an evacuated or tubing, such as tubing sold under the trademark VACUTAINER ^™ by Becton Dickinson. Needle assemblies for use with an evacuated fluid collection tube include a needle hub having a proximal end, a distal end, and a passageway extending between the ends. which is attached to the needle "hub". The needle cannula has a sharply tapered distal end projecting distally beyond the needle "hub", a proximal end projecting proximally beyond the needle "hub", and a lumen providing communication. Connection between the opposite ends of the needle cannula results. Some needle assemblies have separate proximal and distal cannulas and rely on a portion of the needle "hub" to provide communication between the lumens of the respective cannulas typically tapered to a point which is sufficiently sharp to pierce the skin of the patient and to gain access to the vein or other source of fluid which is to be collected; The proximal end of the needle cannula is configured to pierce the rubber stopper on an evacuated tube The proximal end of the needle cannula is typically through a needle pierceable, resealable multi or multiple sample tube The sleeve is compressed by the rubber plug of the evacuated tube and compressed by the The proximal end of the needle cannula is punctured or pierced when the proximal end of the needle cannula is forced into communication with the evacuated tube.

One Problem or difficulty with the collection or removal of fluid from a patient refers to insecurity during attempts to to gain access to the exact source of fluid in the patient receive. For example, a blood sampling procedure typically requires of the phlebotomist to visually locate a vein and then enter or penetrate into the vein with the distal end of the needle cannula. The phlebotomist may not have a positive indication at this stage or display of the venous Entrance. A evacuated tube is then placed in communication with the proximal end of the needle cannula when once the phlebotomist is quite certain that is targeted in that taken blood vessel has been. The low pressure inside the evacuated tube cooperates or works with the higher one Pressure of the blood together to a stream or flow of blood into the tube to create. The flow of blood into the tube may be the first positive Indication for be the phlebotomist that gives access to the targeted Preserved blood vessel has been. The initial flow of blood along the long needle cannula and in the evacuated tube can be a relatively long time Take time based on various factors, including the relative pressure level and the length and the cross-sectional dimensions of the needle cannula. The phlebotomist can do that Lack of an immediate stream of blood as a sign to interpret that the blood vessel is not was precisely targeted, if indeed the absence of a visible Bloodstream in the evacuated tube attributed to the pressure and fluid flow characteristics can be. Consequently, the phlebotomist can unnecessarily pull out the needle and start the blood collection procedure again. As a result, will Time is wasted and the trauma for the patient is increased. in the In view of the above difficulties, many fluid take-up needle arrays are with a flashback chamber provided which communicates with the needle cannula. The Flashback chamber is typically at least partially off a transparent or transparent or translucent material and is intended to receive a portion of the bloodstream shortly after a precise access to a vein has been obtained.

The blood collection needle assembly is withdrawn from the patient after a suitable number of samples have been taken. The needle assembly used is then discarded. The medical profession is well aware that inadvertent punctures with a used needle cannula can transmit disease. Accordingly, it is desirable to shield the used needle cannula immediately after the needle cannula has been withdrawn from the patient. Umbrellas or shields have taken many different forms. For example Extends some shields in a distal to proximal direction over the needle cannula and frictionally engages the needle "hub." Shields of this type create the risk of inadvertent needle puncture during shielding when the shield is misaligned with the needle cannula Some shields of this general type are provided with enlarged collars designed to minimize the risk of inadvertent punctures during shielding, however, shields of this general type are not preferred. Hub "extended and can be moved distally over the needle cannula to effect shielding. Shieldings of this general type are safe and effective and are used in many situations. However, shields of this type can interfere with the normal use of some medical devices or instruments. Other shields are hingedly attached to or near the needle "hub" and can be rotated from an open position exposing the needle cannula to a closed position where the needle cannula is shielded of this type also work well and are widely accepted, however, the presence of a hinged shield on a fluid pickup needle assembly with a flashback chamber is intuitively problematic in terms of complexities, both shielding and shielding to provide an unobstructed view of the flashback chamber.

Summary the invention

The representational The invention is directed to a shieldable fluid collection needle assembly. The needle assembly has a housing with a proximal end wall, a distal end wall, and an outer side wall in between the proximal and distal end walls in the way that a chamber extends between the end walls and the outer sidewall defined is. The outer side wall can be uniformly formed with at least one of the end walls be. additionally is at least a portion of the outer sidewall from a transparent or transparent or translucent Material formed so that the interior of the chamber visible within the housing is. A proximal passage extends through the proximal End wall of the housing and a distal passage extends through the distal end wall of the housing. The proximal and distal passages may be axially aligned with each other be. The housing may further include an inner sidewall extending proximally from the distal end wall extends and the entrance or entry of the surrounds the distal passage in the chamber. The inner sidewall is also a transparent or translucent material.

The Needle assembly further includes a distal cannula, which in the distal Passage of the housing is mounted and protrudes distally beyond the housing. The distal cannula has a distal end that is spaced externally from the housing. The distal end may be tapered to a point or conical which is sufficiently thick to the skin of a patient to pierce. The distal cannula has a lumen extending from the distal end of the distal Cannula extends and with the chamber of the housing communicates or communicates.

The Needle assembly further includes a proximal cannula, which in the proximal Passage of the housing is appropriate. The proximal cannula has a proximal end which projects proximally beyond the housing. Additionally points the proximal cannula a lumen extending from the proximal end and in communication or connects to the chamber. The proximal cannula points also a distal end extending into the chamber can, so that the proximal end of the distal cannula and the distal end of the proximal cannula are substantially aligned with each other and easy from each other are spaced. In an alternative embodiment, the distal and proximal cannula They can be integral with each other and they can have a transverse slot or one transverse opening have a connection between the lumens of the distal and proximal cannulas with the chamber in the housing to surrender.

The proximal end of the distal cannula is preferably at or near the distal end wall of the housing. additionally Preferably, the distal end of the proximal cannula extends through a main area of the chamber of the housing and close to a location to the distal end wall of the housing. Consequently, both the distal and proximal cannula are preferred with the chamber of the needle assembly at a location close to the distal End wall of the housing in Connection. As a result, the first indication or display a fluid flow through the distal cannula at a location at or occur substantially adjacent to the distal end wall of the housing. In a preferred embodiment may the housing having the above-described inner sidewall and the distal one End of the proximal cannula can protrude axially into the cylindrical space, passing through the inner space Sidewall is limited.

The needle assembly of the subject The invention further includes a shield which may be hingedly connected at a location on the housing proximal to the location where the first indication of flashback occurs. The shield is initially in an open position in which the shield is spaced from the distal cannula and the chamber. Therefore, the shield does not hinder the use of the distal cannula or the visual observation of the chamber when the shield is in its open position. However, the shield may be rotated from the open position to a closed position in which the shield surrounds the distal cannula. The shield and / or housing may include at least one locking member for locking the shield in the closed position. The locking means may comprise a resilient, deflectable cannula lock configured to engage the needle cannula when the shield is in the closed position. The shield may further include latches in engagement with a structure on the housing when the shield is in the closed position. The engagement between the structure on the shield and the structure on the housing may function to lock the shield in the closed position. Alternatively, primary locking of the shield in the closed position may be accomplished through the cannula lock, and engagement between the shield and the housing may be primarily for audible and tactile indication of the complete shield.

description the drawings

1 Figure 11 is an exploded perspective view of a needle assembly in accordance with the invention.

2 is a longitudinal sectional view of the needle assembly prior to use.

3 Figure 10 is a side view of the needle assembly after it is placed in communication with a blood vessel, but before it is placed in communication with an evacuated tube.

4 Figure 12 is a longitudinal sectional view of the needle assembly during use and after it is placed in communication with an evacuated tube.

5 is a side view of the needle assembly after complete shielding.

detailed description

A needle assembly in accordance with the subject invention is generally by the Ziff. 10 in 1 to 5 identified. The needle assembly 10 has a housing 12 with a proximal end 14 , a distal end 16 and a substantially frusto-conical outer sidewall 18 on, which extends between the ends. The outer side wall 18 is formed of a transparent or translucent plastic material and defines a chamber 20 inside the case 12 between the proximal end 14 and the distal end 16 , A proximal passageway (not shown) extends through the proximal end 14 of the housing 12 and stands with the chamber 20 in connection. A distal passage 22 extends through the distal end 16 of the housing 12 and is also with the chamber 20 in connection. The housing 12 also includes a cylindrical inner sidewall 24 extending from the distal end 16 towards the proximal end 14 extends. The inner sidewall 24 is inside the outer sidewall 18 is arranged substantially concentrically and is around the distal passageway 22 around substantially concentric generated or formed. The inner sidewall 24 is also formed of a transparent or translucent plastic material. Therefore, a fluid material is in a region of the chamber 20 passing through the inner sidewall 24 is limited, from locations outside the outer sidewall 18 easily visible. Consequently, the inner sidewall defines 24 in this embodiment, a flashback chamber 26 and in the flashback chamber 26 collected fluid may be from locations outside the needle assembly 10 to be watched. The chamber 26 stands with the chamber 20 in conjunction and therefore the chamber can 20 also contribute to an indication or display of flashback.

The needle assembly 10 also has an IV or intravenous cannula 30 with a proximal end 32 , a distal end 34 and a lumen 36 on, which extends between the ends. The distal end 34 the IV cannula 30 is outside the case 12 is arranged and tapered to a sufficiently sharp tip for piercing the skin and tissue of a patient or tapered. The IV cannula 30 is in the distal passage 22 of the housing 12 attached so that the proximal end 32 the IV cannula 30 to the distal end 16 of the housing 12 is substantially adjacent or adjacent. Consequently, the lumen stands 36 through the IV cannula 30 with the flashback chamber 26 in contact with the distal end 16 of the housing 12 is substantially adjacent or adjacent.

The needle assembly 10 also has a non-patient (NP) cannula 40 in the proximal passage at the proximal end 14 of the housing 12 is appropriate. The NP cannula 40 has a proximal end 42 that outside the case 12 is arranged, a distal end 44 that in the flashback chamber 26 and a lumen (not shown) extending between the ends. The proximal end 42 is chamfered to a sharp enough point to pierce a rubber stopper of an evacuated tube, as further explained herein. The lumen through the NP cannula 40 is substantially axial with the lumen 36 through the IV cannula 30 aligned. The distal end 44 the NP cannula 40 is preferably only a short distance away from the proximal end 32 the IV cannula 30 spaced, for example, 0.5 mm to 1.2 mm.

The needle assembly 10 also has a sleeve 46 on top of areas of the NP cannula 40 attached, which is outside the case 12 are arranged. The sleeve 46 is at the proximal end 14 of the housing 12 attached and is formed of a material which is substantially impermeable to liquid and fluid. However, the sleeve is 46 also formed from a material passing through the proximal end 42 the NP cannula 40 is easily durchstoßbar and which resealable or -abdichtbar in resilient or yielding resilient manner. Consequently, the rubber stopper of an evacuated tube against the sleeve 46 be pushed and become the sleeve 46 cause it to collapse distally or to fold together. As a result, the bevelled tip becomes at the proximal end 42 the NP cannula 40 through the sleeve 46 and push through the rubber stopper at the evacuated Röhe.

The IV cannula 30 , the NP cannula 40 and the case 12 work together to provide early indication of venous entry due to the flashback of blood in the chamber 26 and / or the chamber 20 of the housing 12 to surrender. However, other flashback designs may be incorporated into the needle assembly of the subject invention. These other embodiments include arrangements in which blood is first the equivalent of the sheath 46 at the needle assembly 10 fills and then flows into a flashback chamber. Still other embodiments involve the use of a ventilated plug. Flashback chamber designs that may be incorporated into the subject invention are described, for example, in US Pat. 5542932, US Pat. 5824001 and others shown.

The needle assembly 10 also has a collar or waistband 50 on, around proximal areas of the housing 12 safely installed around. The collar 50 Can be in position on the housing 12 mechanically fastened, it can with the housing 12 be bonded or glued or he can as part of the housing 12 be formed. The collar 50 has a proximal end 52 with proximal areas of the chamber 20 is substantially aligned, and a distal end 54 on, the proximal of the proximal end 32 the IV cannula 30 and near the proximal end of the inner sidewall 24 is arranged. Accordingly, the collar 50 the ability does not affect regions of the flashback chamber 26 adjacent to the proximal end 32 the IV cannula 30 to observe. The distal end 54 of the collar 50 is with a C-shaped hook 56 provided around an axis transverse to the IV cannula 30 and the NP cannula 40 extends. The collar 50 also has a chevron-shaped projection 58 at a point diametrically opposite or opposite to the hook 56 on. The collar 50 is preferably on the housing 12 fastened in such a way that a plane which symmetrically through the C-shaped hook 56 and by the diametrically opposed or chevron-shaped projection 58 goes, also symmetrically through the bevel or cone at the distal end 34 the IV cannula 30 goes. However, in other embodiments, the collar 50 on the housing 12 be rotatably mounted so that the orientation or orientation of the plane symmetrical through the hook 56 and by the projection 58 can be varied or changed relative to a plane which is symmetrical by the bevel at the distal end 34 the IV cannula 30 goes.

The needle assembly 10 also has a screen 60 with a proximal end 62 and a distal end 64 on. Areas of shielding 60 close to the proximal end 62 have a hinge pin or pin 66 on which is engaged with the hook 56 is snapped, leaving the shield 60 relative to the hook 56 from an in 1 and 2 shown, open position to one in 5 shown, closed position can rotate. In the open position is the shield 60 from the IV cannula 30 spaced and to the IV cannula 30 aligned at an obtuse angle of about 120 °. The preferred orientation or orientation of the collar 50 relative to the chamfer at the distal end 34 the IV cannula 30 gives a clear or clear indication of the preferred oblique or oblique orientation of the IV cannula 30 which is used by most health professionals during the application. In addition, the orientation of the collar ensures 50 on the housing 12 that the shield 60 the view of the or observation of the IV cannula 30 does not interfere during insertion will be. The above-mentioned option of a rotatable collar allows the user a preferred orientation of the shield 60 relative to the chamfer at the distal end 34 the IV cannula 30 and relative to the patients and other medical equipment that may be placed in association with the patient. Areas of shielding 60 close to the proximal end 62 further have an upper wall 68 and sidewalls 70 and 72 on which of the upper wall 68 protrude. Areas of the side walls 70 and 72 at the proximal end 62 the shield 60 are spaced apart by a distance equal to the width of the outer sidewall 18 of the housing 12 is or the width of the outer sidewall 18 of the housing 12 exceeds. Consequently, the side walls 70 and 72 on respective opposite sides of the outer side wall 18 be easily turned when the shield 60 inside the hook 56 is turned. The wide or large spacing of the side walls 70 and 72 also facilitates observations of the flashback chamber 26 , Opposite surfaces of the side walls 70 and 72 at the proximal end 62 the shield 60 are with respective collar locks 74 and 76 Mistake. The collar locks 74 and 76 are configured to engage the chevron-shaped latch or latch 58 on the collar 50 to snap. The upper wall 68 is provided with a series of tactile bumps on the surface of the sidewalls 70 and 72 points away to give a visual indication of an actuating surface for a thumb or forefinger and to enhance a frictional engagement by the thumb or forefinger when the shield 60 is turned.

The shield 60 narrows in places between the upper wall 68 and the distal end 64 and defines a substantially U-shaped channel of sufficient width around the IV cannula 30 take. As most clearly in 5 shown is the channel 78 sufficiently long to complete the IV needle 30 to surround or enclose. Inner areas of the canal 78 have a resilient deflectable cannula lock 80 on which of a side wall of the channel 78 is angled toward the opposite side wall and angled towards the top wall, respectively. The cannula lock 80 is in response to a contact with the IV cannula 30 give way or relax when the shield 60 towards the IV cannula 30 is turned. The cannula lock 80 is still sized to attach to the IV cannula 30 to go over when the shielding 60 approaches the closed position. Therefore, the cannula lock becomes 80 return to an undeflected position resilient and becomes the IV cannula 30 within the shield 60 catch. Although the figures herein are a single cannula lock 80 show, multiple cannula locks may be provided. In addition, the cannula locks may be from each of the two side walls of the U-shaped channel 80 extend. Other structures or embodiments for the locking of the IV cannula 30 in the shield 60 can be provided. These include other configurations for plastic or metal cannula locks that respond in response to contact with the IV cannula 30 deflected and then move resiliently to the IV cannula 30 capture. Alternatively, the cannula lock may require some form of user activation, eg, rotation or axial movement of a portion of the shield.

The needle assembly 10 also has an IV shield 82 and an NP shield 84 on which each above or on the IV cannula 30 and the NP cannula 40 attached and on the collar 50 are held frictionally engaged. The shields 82 and 84 can be separated by a suitable application or application of a tensile and / or a slight twisting force.

The needle assembly 10 is done by first separating the NP shield 84 from the collar 50 and then by screwing the distal end 14 of the housing 12 in a needle holder 86 applied. The shield 60 is then turned to the fully open position in 1 and 2 is shown in the shield 60 from the IV cannula 30 is spaced apart and to the IV cannula 30 is aligned at an obtuse angle of about 120 °. The IV shield 78 will then be out of engagement with the collar 50 away. The phlebotomist then leads the distal end 34 the IV cannula 30 into a targeted blood vessel. A pressure difference between the blood in the vein and the pressure inside the case 12 will cause the blood to pass through the lumen 36 the IV cannula 30 to flow. Blood gets into the flashback chamber 26 appear very quickly after access to the blood vessel has been obtained. This blood can pass through the phlebotomist in the flashback chamber 26 due to the arrangement and orientation of the shield 60 be observed in the open position. The phlebotomist then sets an evacuated tube 88 in the needle holder 82 one. The evacuated tube 88 has a rubber stopper 90 on which the sleeve 46 distally collapsed or compressed. As a result, the proximal end pierces 42 the NP cannula 40 the rubber sleeve 46 and then pierces the plug 90 the evacuated tube 88 , Of the Phlebotomist collects one or more samples of blood in this way.

After collecting the last sample of blood, the phlebotomist brings the needle assembly 10 and the needle holder 86 away from the patient and immediately applies pressure to the top wall with a thumb or forefinger 68 the shield 60 out. As a result, the shield rotates 60 around the hook 56 in a closed position, as in 5 shown so that the IV cannula 30 through the channel 78 the shield 60 is surrounded. Sufficient rotation causes the cannula lock 80 to do so, with the IV cannula 30 to be engaged and distracted or distracted. Another rotation of the shield 60 initiates the cannula lock 80 in addition to the IV cannula 30 to go over. As a result, the cannula lock returns 80 returns to an undeflected state and captures the IV cannula 30 one. At the same time snap the collar locks 74 and 76 in engagement with the chevron-shaped lock 58 on the collar 50 to give an audible and tactile indication of the screen. The securely shielded needle assembly may then be discarded into a cannula container.

The needle assembly provides effective shielding without the use of the needle assembly 10 obstruct and without the observation of the flashback chamber 26 to cover up. The high visibility of the Flashback chamber 26 is partly the extreme distal position of the space or space between the IV cannula 30 and the NP cannula 40 and the corresponding proximal position of the shield 60 attributed in the open position. In addition, as most clearly in 1 shown is the proximal end 62 the shield 60 between the side walls 70 and ( 72 ) wide open to give a wide range of acceptable viewing angles.

In the needle assembly described above, the hinge pin 66 the shield 60 in engagement with the C-shaped hook 56 on the collar 50 for an articulated or pivotable rotation of the shield 60 relative to the collar 50 and relative to the housing 12 snapped. However, other structures or configurations for adapting an articulated or pivotable movement of the shield 60 relative to the collar 50 and / or the housing 12 be provided. These involve forming the shield 60 consistent with the collar 50 so that a living hinged or pivotable connection between the shield 60 and the collar 50 is provided. A living hinge shield is described, for example, in US Pat. Shown 5681295. Such hinged connections may also include an "over-center" hinge or joint movable beyond a center position into a respective end position, wherein the shield is substantially biased in the fully open position and in the fully closed position However, the user may have to overcome a bias in the over-center hinge during the initial stages of rotation from the open position to the closed position. The over-center hinge then returns resiliently to a non-biased condition and accelerates the hinge to the closed position.

Claims (14)

Needle assembly comprising: A housing with proximal and distal ends and a chamber wall extending between extends the ends to define a chamber in the housing, wherein at least an area of the chamber wall is formed of a material which an observation of a fluid or fluid allowed in the Chamber flows, and an IV or intravenous cannula the one from the case protrudes distally and communicates with the chamber or in connection stands, a screen or shield hinged to or with the housing or articulated or pivotally connected and in an open Position can be positioned, in which the screen spaced from the IV cannula is and is aligned to allow an observation of the chamber wherein the screen is further rotatable to a closed position in which the screen covers or covers the IV cannula. A needle assembly according to claim 1, wherein at least an area of the chamber is located distally of a site which the screen with the housing pivotally connected. A needle assembly according to claim 2, wherein the IV cannula is provided with a Area of the chamber adjacent or adjacent to the distal end of the housing communicates, wherein the screen with a Area of the housing, the substantially adjacent or adjacent to the proximal End of the case is pivotally connected. Needle arrangement according to one of claims 1 to 3, wherein the screen at least one lock for a locking engagement with the IV cannula when the screen is in the closed position. A needle assembly according to any one of claims 1 to 4, wherein the shield comprises at least one barrier Direction or pawl for engaging with a portion of the housing, which is spaced from the articulated or pivotable connection when the screen is in the closed position. A needle assembly according to claim 5, wherein at least a latch on the screen for engaging with the housing designed to be audible and tactile or to produce tactile indications or displays of the shield. Needle arrangement according to one of claims 1 to 6, further comprising a non-patient cannula protruding from the housing and communicates with the chamber. The needle assembly of claim 7, wherein the non-patient cannula is a distal one End located in the chamber, wherein the distal end the non-patient cannula distal from the articulated or pivotable connection of the screen with the housing is arranged. The needle assembly of claim 8, wherein the non-patient cannula is through the housing extends sufficiently so that the distal end of the non-patient cannula substantially is adjacent to the distal end of the housing, the distal end of the non-patient cannula with the IV cannula is essentially aligned and from the IV cannula is slightly spaced. Needle arrangement according to one of claims 1 to 9, in which the chamber wall is an outer chamber wall is, the case further comprising an inner chamber wall which is a flashback or Zurückversetzungs- or flashback chamber within of the housing defined, wherein the inner chamber wall of the distal end of the housing extending in the direction toward the proximal end of the housing, that the IV cannula communicates with the flashback chamber, which is through the inner Chamber wall is defined. Needle arrangement according to one of claims 1 to 10, where the case a collar surrounding a portion of the housing is arranged, wherein the screen hinged to or with the collar or hinged or pivotally connected. The needle assembly of claim 11, wherein the collar on the housing is attached. Needle assembly according to claim 11, wherein the housing has a central or central axis extending between the proximal and distal ends, with the collar about the central axis rotatable or rotatable about the screen in a preferred, orient rotational orientation relative to the IV cannula or to align. Needle arrangement according to one of claims 11 to 13, wherein the collar on the housing at a location proximal in relation to the chamber is attached.