The disclosed invention relates generally to blood sampling devices, systems and methods for taking a blood sample from a patient using a blood sample vial. Detailed discussions extend to blood sampling devices, systems and methods that include a passive needle guard mounted over a collection needle for covering the needle tip upon retraction of the needle.
Medical care of individuals requires the widespread use of needles for taking blood samples, intravenous drug delivery, and the introduction or removal of other fluids. In the current context, the use of hypodermic needles to take blood samples has become commonplace in medicine, science, veterinary medicine, and biotechnology. The use of a hypodermic needle typically involves first inserting a needle into the patient, withdrawing a substance as required, and then removing the needle from the patient. In most applications, the withdrawn and contaminated needle must be handled very carefully during disposal to avoid a needle stick injury.
To help prevent health care workers from becoming injured when handling used needles, safety guards have been developed to block the tip of these needles. Indeed, needle stick protection for medical professionals has become of particular importance in recent years because of the prevalence of potentially fatal infectious diseases, such as, for example, Acquired Immune Deficiency Syndrome (AIDS) and hepatitis, that can be transmitted by the exchange of bodily fluids through inadvertent wounds caused by accidental needle tip pricks from handling used needles.
Accordingly, many kinds of needle protection devices have been devised for providing post injection needle stick protection. These devices generally fall into three basic categories: those which hide the withdrawn needle within a needle shield, those which require placement of a separate needle guard that slides along the needle to cover the needle tip, and those which include a sliding shield for covering the tip of the used needle.
A passive safety needle blood sampling device is disclosed. The safety device can comprise a housing comprising a needle holder comprising a base with a flange, a distal end wall, and a body wall having an interior diameter defining an interior cavity and an exterior diameter. The body wall defines a lengthwise longitudinal axis having an open proximal end. A cap is provided having wall structure comprising an exterior surface, an interior surface defining an interior cavity, a distal end, and a proximal end connected to a distal end of the housing. At least one catch formed upon the cap, the at least one catch comprising a projection. In an example, the projection has a rectangular section extending distally of a connection point on the cap and comprising a triangular shaped section comprising a portion extending partially radially inward into the interior cavity of the cap. A needle comprising a distal end section and a proximal end section, the distal end section extending distally of the distal end of the cap and the proximal end section of the needle extending into the interior cavity of the housing and having a deformable sleeve mounted there-over forming a multi-sampling Luer adaptor. The distal end section and the proximal end section can be formed on a single shaft or from two different shafts. A safety shield comprising a first elongated section surrounding at least a portion of the distal end section of the needle and a second enlarged section comprising an interior having a shoulder, an exterior, and a flange at a proximal end thereof for covering the needle is provided. An activator is provided for activating the safety shield. The activator can comprise a body wall structure having a distal end with a distal end wall and a proximal end with an opening through which the multi-sampling Luer adaptor extends; said activator comprising two spaced apart legs with each leg comprising a hook end and extending through the distal end wall of the housing and gripping the flange on the second enlarged section of the safety shield such that the distal end wall of the activator is spaced from the distal end wall of the housing by a starting gap in a ready to use position. A helical spring is positioned in the interior of the second enlarged section of the safety shield and compressed by the shoulder of the second enlarged section and the distal end wall of the housing for moving the safety shield. The spring is held compressed by the hook ends of the two legs gripping the flange on the safety shield. A ramped section at the distal end wall of the housing in abutting contact with the two spaced apart arms; wherein the activator is movable distally when a sampling vial is inserted into the open proximal end of the housing and pushing on the activator in a distal direction, whereupon the two legs deflect by the ramped section at the distal end wall of the housing to be further spaced from one another to release the flange on the safety shield from the gripping by the two hook ends. In some examples, the distal end wall of the activator is spaced from the distal end wall of the housing by an activated gap in a protective position, which is less than the starting gap, when the two spaced apart arms no longer grip the flange on the safety shield.
A further passive safety needle blood sampling device is disclosed. The device comprises a needle comprising a distal end comprising a distal tip and a proximal end comprising a proximal tip. The proximal end has a deformable sleeve mounted there-over forming a multi-sampling Luer adaptor. A housing is provided sized and shaped to receive a blood sampling vial and comprising a base comprising a flange and having a hollow member disposed therein and fixed in relative relation therewith; said hollow member comprising an end wall comprising a plurality of openings. A protective shield is provided comprising at least two deflectable legs each comprising a hook end coaxially disposed with the hollow member and having the two hook ends engaged with two of the openings on the hollow member. A helical spring is provided compressed on one end by the protective shield and another end by the end wall of the hollow cylinder. An activator is provided comprising a base having a central opening and two spaced apart leg elements each comprising a hook end and wherein the two spaced apart leg elements extending through a respective opening on the end wall of the hollow cylinder and the two hook ends gripping the hollow cylinder such that the base of the activator is spaced from the end wall of the hollow cylinder by a starting gap in a ready to use position. Wherein when the activator is moved distally by a blood sampling vial, the two leg elements move to press against the two hook ends on the two deflectable legs of the protective shield to release the helical spring; and wherein the base of the activator is spaced from the end wall of the hollow cylinder by an activated gap, which is less than the starting gap, when the two leg elements move to press against the two hook ends on the two deflectable legs of the protective shield.
A further feature of the present disclosure is a blood collection needle assembly comprising a housing comprising a body defining an interior cavity and having a distal wall with an opening and an open proximal end for receiving a vacutainer comprising a septum; an actuator located within the interior cavity of the housing and having an arm with an arm section extending through the opening on the distal wall for gripping a second shield section of a safety shield, which has an elongated first shield section sized for surrounding a needle having a first shaft section extending distally of the distal wall of the housing and a second shaft section extending proximally of the distal wall of the housing; a biasing spring compressed between the safety shield and the housing; and wherein the actuator is movable towards the distal wall of the housing to release the second shield section from the arm section to allow the biasing spring to expand.
The blood collection needle assembly wherein the housing can comprise a housing actuator with a tapered wall extending proximally of the distal wall for interacting with the arm of the actuator.
The blood collection needle assembly wherein the actuator can comprise a cylindrical body section comprising a distal wall with an opening and an open proximal end.
The blood collection needle assembly wherein the arm is a first arm and the assembly can further comprise a second arm and wherein the first arm and the second arm extend distally from the distal wall of the actuator.
The blood collection needle assembly can further comprise a cap disposed concentrically around the needle shield and the needle.
The blood collection needle assembly wherein the cap can comprise at least one spring arm having a raised tip for abutting the second shield section in the safety shield protective position.
The blood collection needle assembly wherein part of the elongated first shield section can extend distally of the cap in a ready position.
The blood collection needle assembly can further comprise a multi-sampling Luer adaptor disposed around the second shaft section.
The blood collection needle assembly wherein the first arm and the second arm each can extend through an opening at the distal wall of the housing to grip a flange on the second shield section.
The blood collection needle assembly wherein the spring can compress between a shoulder in the second shield section and the distal wall in a ready position.
A still yet further feature of the present disclosure is a blood collection needle assembly comprising: a housing comprising a body defining an interior cavity and an open proximal end for receiving a vacutainer comprising a septum; a housing actuator comprising a body and a base disposed inside the interior cavity of the housing, said base comprising a circumference in abutting contact with an interior surface of the interior cavity, a needle post for holding a needle comprising a first shaft end and a second shaft end, and an opening spaced from the needle post; an actuator comprising a base bar and at least one arm located within the interior cavity of the housing and having the at least one arm extending through the opening on the base of the housing actuator and the base bar spaced from the base of the housing actuator in a ready position; a needle shield slidably disposed relative to the body of the housing actuator; and a biasing spring compressed between the safety shield and the housing actuator; and wherein the base bar of the actuator is movable towards the base of the housing actuator to release the needle safety shield to allow the biasing spring to expand.
The blood collection needle assembly wherein the actuator can comprise a second arm extending distally of the base bar.
The blood collection needle assembly wherein the second arm can extend through a second opening on the base of the housing actuator.
The blood collection needle assembly wherein the body of the housing actuator can be generally cylindrical and wherein the shield can be disposed, at least in part, in an interior of the housing actuator.
The blood collection needle assembly wherein the needle shield can comprise at least two leaf springs each with a hook end and wherein each hook end is engaged to an opening formed on the body of the housing actuator.
The blood collection needle assembly wherein the biasing spring has two ends and wherein a first end of the spring can be biased by an end wall of the needle shield and a second end of the spring can be biased by the base of the housing actuator.
The blood collection needle assembly wherein the arm and the second arm of the actuator can each comprise a projection that presses against the body of the housing actuator.
The blood collection needle assembly can further comprise a multi-sampling Luer adaptor positioned over the second shaft end.
The blood collection needle assembly wherein the multi-sampling Luer adaptor can project through an opening on the base bar of the actuator.
A still yet further feature of the present disclosure is a method for manufacturing and a method for using the blood collection needle assembly disclosed herein.
These and other features and advantages of the present devices, systems, and methods will become appreciated as the same become better understood with reference to the specification, claims and appended drawings wherein:
The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of collection assemblies provided in accordance with aspects of the present devices, systems, and methods and is not intended to represent the only forms in which the present devices, systems, and methods may be constructed or utilized. The description sets forth the features and the steps for constructing and using the embodiments of the present devices, systems, and methods in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.
With reference now to
As shown, the cap 102 comprises a body 116 comprising a base 118, an elongated body chamber 120, and a shoulder 122 located therebetween. In the example shown, the base is generally round 118 and defines an opening for receiving the holder 110, as further discussed below. An internal shoulder is provided in the interior of the cap 102 and located near the external shoulder 122 for delimiting the amount of insertion of the housing into the opening of the base 118. The elongated body chamber 120 has a first generally cylindrical lower section 124 and a tapered upper section 126 comprising a distal opening 128. Two channels 130 (only one shown) are incorporated in the tapered upper section 126 with each comprising a resilient spring arm 132, which may also be referred to as a cantilevered arm 132 formed by providing a gap around three sides of an extended surface. The cantilevered arm 132, which can operate like a leaf spring, may extend proximally or distally, depending on the particular application. A raised tip 133 (
The protective shield 104 is shown with a base 134 and a shield section 136, which has a distal opening 138. The base comprises a flange 140, a tapered base body 142, which terminates in an upper base body section or slender section 144 of the base having a different contour than the tapered base body 142. A base body end surface 146 is provided at the distal end of the base 134 and has the shield section 136 extending distally thereof. The shield section 136 is generally elongated and, as shown, generally cylindrical. The shield section 136 is sized and shaped to envelope at least part of the needle 108 in the protective position to cover the needle from inadvertent needlesticks. Both the shield 104 and the cap may be made from thermoplastic, such as by plastic injection.
The needle 108 shown has a needle shaft 148, a first pointed or sharp tip 150 and a second pointed or sharp tip 152. The first sharp tip 150 is configured to penetrate a patient or subject during venipuncture while the second sharp tip 152 is configured to penetrate the septum of the vacuum tube.
The spring 106 shown is a compression spring, which is configured to compress in the ready to use position and expands to push the distal end of the cap 104 over the first sharp tip 150, as further discussed below.
The needle holder 110 has a body 156 comprising a distal end 158 and a proximal end 160. The distal end 158 comprises a closed distal end surface 160, a needle holder or post 162 for holding the needle 106, and a pair of openings or ports 164a, 164b for coupling with the activator, as further discussed below. A gripping flange 166 is provided at the proximal end of the body 156, which has an opening that leads to the interior cavity of the body 156 for receiving a vacuum tube, which is commonly referred to as a vacutainer in the relevant industry. The gripping flange provides a structure or surface for griping the assembly during venipuncture.
The activator 112 is shown with a generally cylindrical body 167 comprising a distal end wall 168 having an opening 170 and a pair of distally extending legs or arms 172a, 172b, which are spaced from one another and anchored from the distal end wall 168 at anchor points 50. The legs 172a, 172b each comprises an axially extending lower portion 174 and a tapered or flared upper section 176, which extend radially outwardly away from a central axis defined by the body 167. A lip 178 is provided at the end of each flared upper section 176. The two lips 178 are configured to hold the flange 140 on the protective shield 104, as further discussed below. The terms “legs” and “arms” are used to designate elongated structures but are not otherwise structurally limiting unless the context indicates otherwise.
The MSLA 114 is a generally elongated rubber or elastomer having a central lumen for receiving the second sharp tip 152 therein. The MSLA has an enlarged distal end 182 that serves to anchor the MSLA against the activator 112, at the opening 170 as shown in
With reference now to
In an example, the two spaced apart legs or arms 172a, 172b of the activator 112 extend through the two corresponding ports 164a, 164b at the distal wall or closed distal end surface 160 of the housing 110. The spaced apart legs are each comprised of three sections 174, 176, 178, as previously discussed. The first section 174 of each leg is generally parallel to the longitudinal axis of the device and extends from the distal wall 168 of the activator 112. The second section 176 of each leg extends distally from the first section and angles partially radially outward away from the longitudinal axis of the device. The third section 178 of each leg extends from the distal end of the second section and comprises hooks or lips that extend radially inward to the longitudinal axis of the device. The spaced apart legs 172a, 172b are configured so that they can deflect about each respective anchored point further apart from one another. In other examples, the three sections of each leg can embody different configurations, such as being tapered from the anchored point 50 and then extend generally parallel with the longitudinal axis. The two hooks or lips 178 grip against the distal wall 160 of the housing 110 to retain the activator 112 to the housing.
As shown, the body 167 of the activator 112 comprises an interior surface 190 defining a hollow interior 192 for receiving an end of a vacutainer (not shown). The wall surface of the body 167 is spaced from the wall surface 194 of the housing by a gap 196. Thus, when a vacutainer is inserted into the device 100, at least at the distal end of the vacutainer, it is held within the body section of the activator 112, which is spaced from the wall surface 194 of the housing 110 by the gap 196.
The protective shield 104 comprises a slender first section or shield section 136 which surrounds the needle 108 and in one embodiment protrudes out the distal opening 128 of the cap 102. In other embodiments, the distal end of the first section 136 may be flushed with or recessed inside the cap 102. A hollow second section or base 134 is attached to the proximal end of the slender first section 136. The hollow second section 134 comprises a flange 140 extending radially from the proximal end and is held against the closed distal end surface 160 of the housing by the lips 178 on the two legs 172a, 172b of the activator. The hollow second section or base 134 is sized and shaped to accommodate the needle holder 162 and the spring 106, which is held in a compressed state by the two hooks on the activator 112. As shown, the spring 106 is positioned over or to the outside of the needle holder 162 and held compressed at its two ends by the distal end surface 160 of the housing 110 and the shoulder 198 inside the protective shield 104. In one example, the spring is a helical spring of sufficient spring force and length to expand the protective shield 104 over the needle tip, as further discussed below.
With further reference to
A housing actuator 200 is provided on the proximal side or interior surface of the distal end wall 160 of the housing 110. As shown, the housing actuator 200 is contoured with a ramped surface 202. The ramped surface is generally shaped as a cuboid protrusion from the proximal side of the distal end wall 160 of the housing 110. The ramped surface 202 slants radially inward from the distal end to the proximal end. The second section 176 of each of the two legs 172a, 172b rests against the ramped surface 202. In one example, the ramped surface 202 forms a continuous structure about the central region of the housing 110. In another example, the ramped surface 202 is non-continuous and is provided in the same general locations as the two axially extending legs 172a, 172b. Preferably, the ramped surface 202 and the tapered upper sections 176 of the two legs form a close surface contact with no space or gap in between. In other examples, a gap is provided. The ramped surface 202 is sized and shaped to contact the two legs without spreading or bending the legs outwardly due to the size difference.
With further reference to the activator 112 and the housing activator 200, a gap is provided between the distal end surface of the end wall 168 of the activator 112 and the proximal most edge 204 of the housing activator 200. This gap allows the activator 112 to move distally forward towards the housing activator 200 and the distal end wall 160 of the housing without being obstructed or limited by the ramped surface structure. As further discussed below, when the actuator 112 is caused to move distally forward into the gap 196, the two ramped surfaces interact to spread the two axially extending legs 172a, 172b, which will then release the flange 140 on the protective shield 104 to then permit the spring to expand.
The base 118 on the cap 102 has a bore at its proximal end with an interior diameter that is greater than the exterior diameter of the housing 110 to receive the housing. A shoulder 206 is provided in the bore of the cap to limit the extent of insertion of the housing 110 into the bore.
With reference now to
Thus, aspects of the present embodiment is understood to include a blood sampling needle assembly in which a needle shield is provided and wherein the needle shield is released from its original position prior to retracting the needle from a patient's vein. The assembly is further understood to comprise an actuator configured for releasing the needle shield. As disclosed, the actuator is slidable or movable along an lengthwise axis of the assembly and has actuator features that move radially of the lengthwise axis. For example, the actuator comprises arms that move radially to release the shield from the arms' hold. In specific examples, the arms are moved by pushing them against ramped surfaces to move radially outwardly.
As shown in
With reference again to
In the present embodiment, the protective shield 242 has an elongated body 256 comprising a tapered nose end 258 with a distal opening 260, two or more elongated slots 262 with each terminating at the proximal end opening 264 and having a radially extending hook end 266. The slots 262 on the body 256 define flexible leaf springs 268 each with at least one hook end 266. As further discussed below, the protective shield 242 is configured to enter the distal opening 270 on the housing 248 and the leaf springs 242 are sized and shaped to deflect and then uncoil so that the hook ends 266 engage corresponding detents 272 formed with the housing 248.
The needle 244 has a needle shaft 274 and is provided with two sharpened needle tips 276 at opposite ends of the shaft 274. As further discussed below, the needle 244 is held by a needle post located inside the housing activator 248. The needle may be secured thereto via conventional means.
Also shown in
With reference now to
Thus, aspects of the present embodiment is understood to include a blood sampling needle assembly in which a needle shield is provided and wherein the needle shield is released from its original position prior to retracting the needle from a patient's vein. The assembly is further understood to comprise an actuator configured for releasing the needle shield. As disclosed, the actuator is slidable or movable along a lengthwise axis of the assembly and has actuator features that move radially of the lengthwise axis. For example, the actuator comprises arms that move radially to release the shield from the arms' hold. In an example, the arms are moved by biasing them in an outwardly position relative to the lengthwise axis and then allowing them to move radially inwardly relative to the lengthwise axis to release the latch on the needle shield. In another example, the arms are moved by providing openings on the needle shield so that projections on the arms are provided with room to move radially inwardly into the openings. Said movement can be configured to trigger the detents on the needle shield to release to subsequently cover the needle tip.
Although limited embodiments of the passive safety needle blood sampling or collection assemblies and their components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, the various protective shields may incorporate translucent or semi-transparent materials allowing a user to view the needle after the needle shield is released, etc. Furthermore, it is understood and contemplated that features specifically discussed for one passive safety needle blood sampling device embodiment may be adopted for inclusion with another passive safety needle blood sampling device embodiment, provided the functions are compatible. For example, a hollow seat for receiving a vial in an activator may be used in another embodiment shown with just the ring and leg elements. Another example includes elements that allow a user to detect flashback. Accordingly, it is to be understood that the safety needle blood sampling device assemblies and their components constructed according to principles of the disclosed device, system, and method may be embodied other than as specifically described herein. The disclosure is also defined in the following claims.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2015/061704 | 5/27/2015 | WO | 00 |
Number | Date | Country | |
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62003440 | May 2014 | US |