PHLEBOTOMY NEEDLE DESTRUCTION
20210220569 · 2021-07-22
Inventors
Cpc classification
H05B6/10
ELECTRICITY
A61M5/3278
HUMAN NECESSITIES
A61M5/3204
HUMAN NECESSITIES
International classification
A61M5/32
HUMAN NECESSITIES
H05B1/02
ELECTRICITY
Abstract
An apparatus for processing a phlebotomy needle having a double-ended needle with a hub between its tips. The apparatus has a clamping electrode for contacting/clamping one end of the needle between the hub and tip and a tip electrode for contacting the needle at its tip. A voltage is applied between the clamping electrode and the tip electrode, to soften/melt the needle via resistive heating, at the same time as the tip electrode is advanced to compress the needle tip and blunt it. The apparatus includes means for allowing the needle to be rotated through so that the first tip and the second tip can be blunted. Also disclosed is means for detaching the needle from a main body and/or for removing a cover covering one end of the needle. The apparatus enables a Vacutainer-type needle to be disassembled into its various parts and the needle rendered blunt and non-hazardous.
Claims
1. An apparatus for processing a phlebotomy needle, the phlebotomy needle comprising: a double-ended needle having a first end terminating in a first tip, and a second end terminating in a second tip; and a hub affixed to the needle at a location between the first tip and the second tip, the apparatus comprising: a clamping electrode for contacting and clamping one end of the needle between the hub and the tip; a tip electrode for contacting the needle at its tip; means for applying a voltage between the clamping electrode and the tip electrode, such that an electric current passes through the end of the needle between the clamping electrode and the tip electrode, which current results, in use. in resistive/Ohmic heating, which heats and softens or melts the tip of the needle; and means for applying an axial force to the tip electrode towards the hub and substantially parallel to an axis of the needle so as to compress and blunt the tip of the needle; the apparatus being characterised by: means for selectively orienting the needle in a first and a second position; the first position being a position in which the clamping electrode clamps the first end of the needle between the hub and the first tip and in which the tip electrode contacts the first tip; and the second position being a position in which the clamping electrode clamps the second end of the needle between the hub and the second tip and in which the tip electrode contacts the second tip.
2. The apparatus of claim 1, wherein the means for selectively orienting the needle comprises a turntable adapted to connect to the hub and to rotate through substantially 180-degrees about a point lying substantially on the axis of the needle.
3. The apparatus of claim 2, wherein the turntable comprises a main body with a through bore whose axis is substantially coaxial with the axis of the needle, the through bore being adapted to connect to the hub of the needle.
4. The apparatus of claim 3, wherein the through bore is internally screw-threaded to screw-threadingly engage with an external screw thread of the hub.
5. The apparatus of claim 1, wherein the phlebotomy needle further comprises a main body affixed to the hub, and wherein the apparatus further comprises a cradle for supporting the main body, the cradle being arranged to support the main body such that the axis of the needle is substantially aligned with a centre of the tip electrode.
6. The apparatus of claim 5, wherein any one or more of the turntable, the cradle and the tip electrode is mounted on a linear slide, which permits the needle to be displaced along a locus that is substantially coaxial with the axis of the needle.
7. The apparatus of claim 6, wherein the turntable, cradle and/or tip electrode is displaced on the linear slide by a linear actuator or a pulley arrangement.
8. The apparatus of claim 1, further comprising a hub grip interposed between the means for selectively orienting the needle and the tip electrode, the hub grip being substantially coaxial with the axis of the needle, adapted to frictionally engage the hub.
9. The apparatus of claim 8, wherein the main body is detachable from the hub by gripping the hub in the hub grip, and by linearly displacing the cradle relative to the hub grip so as to slide or shear the main body off the hub.
10. The apparatus of claim 8, wherein the hub grip further comprises means for rotating the hub grip about the axis of the needle, and wherein the main body is detachable from the hub by gripping the hub in the hub grip, by rotating the hub grip, and optionally by linearly displacing the cradle so as to unscrew the main body from the hub.
11. The apparatus of claim 5, further comprising means for inverting the cradle to release the main body therefrom.
12. The apparatus of claim 1, wherein an end of the needle comprises a cover, and wherein the cover is detachable from the needle by the steps of: displacing the needle such that the cover is positioned between the clamping electrodes; moving the clamping electrodes towards one another so as to grip the cover therebetween; and linear displacement of the needle away from the clamping electrodes so as to slide or shear the cover from the needle.
13. The apparatus of claim 12, further comprising the steps of: moving the clamping electrodes apart; and moving the tip electrode so as to remove the cover from between the clamping electrodes.
14. The apparatus of claim 1, further comprising a tube for receiving a tip of the needle and within which the tip electrode is arranged to slide, the tube being configured to support the needle and prevent or inhibit bowing/bucking thereof during axial compression of the needle by containing the needle as it is melted or softened, and thus prevent discrete droplets of molten needle forming.
15. The apparatus of claim 14, further comprising a thermostatically-controlled healing coil surrounding the tube for pre-heating the tube prior to melting the needle.
16. The apparatus of claim 14, further comprising an induction coil surrounding the tube for pre-heating and/or heating or melting the needle.
17. The apparatus of claim 1, wherein the clamping electrode comprises a pair of opposing metal jaws which move towards each other so as to clamp a portion of the needle therebetween.
18. The apparatus of claim 1, wherein the clamping electrode clamps the needle at any one or more of the positions from the group comprising: within 10 mm of the hub; within 5 mm of the hub; within 2 mm of the hub; within 1 mm of the hub; and more than 1 mm from the hub.
19. The apparatus of claim 1, wherein the tip electrode comprises a concave surface for centralising the tip of the needle therewith.
20. The apparatus of claim 1, wherein the means for applying a voltage comprises any one or more of the group comprising: a DC power supply; an AC power supply; and an RF power supply, the AC, DC or RF power supply is adapted to apply a pulsed voltage between the clamping and tip electrodes, and optionally wherein the AC, DC or RF power supply is adapted to alternately apply a voltage: between the first clamping and first tip electrodes; and between the second clamping and second tip electrodes.
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Description
[0037] Various embodiments of the invention shall now be described, by way of example only, with reference to the accompanying drawings in which:
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
[0049] Referring to
[0050]
[0051] Referring now to
[0052] Next, as shown in
[0053] As can be seen with reference to
[0054] It will be appreciated, by the skilled reader, that upon subsequent withdrawing of the vacuum container 32 from the phlebotomy needle 10, that the bung 38 self-closes as it passes the tip 16 of the needle, thereby sealing a blood sample 44 inside the interior volume 34 of the vacuum container 32. Moreover, upon withdrawing the vacuum container 32 from the main body 20 of the phlebotomy needle 10, the rubber cover 22 tends to spring back to its original configuration, such as shown in
[0055] It will also be understood by the skilled reader that the same phlebotomy needle can be used to obtain several samples—simply by using a second, third or more vacuum containers 32 in sequence with the needle 10 kept in situ.
[0056] Once sufficient samples have been taken, the phlebotomy needle 10 can be withdrawn from the patient's skin 16 and pressure applied to stop bleeding. Thereafter, the phlebotomy needle 10 needs to be disposed of safely if its first end 14 or its second end 16 are not to pose a needlestick injury hazard to the phlebotomist.
[0057] Turning now to the invention, which is described with reference to
[0058] In
[0059] Referring to
[0060] A tip electrode 54 is offered up to the tip of the first end 14 of the needle 12 and an axial force 56 is applied so that the tip electrode 54 abuts the tip of the needle 12.
[0061] Typically, the tip electrode 54 is made of metal so as it can provide a current path through the needle between the clamping electrodes 52 and the tip electrode 54. Typically, the tip electrode 54 has a concave end so as to maintain the correct alignment of the needle 12 during the subsequent processing step.
[0062] A containment cylinder (not shown) may be provided around the needle 12 so as to prevent it from flexing or bowing under the application of the axial stress 56. The use of a containment cylinder, or indeed a heated containment cylinder, is described in published PCT application number WO2015011443, the entire teaching of which is incorporated herein by reference.
[0063] A voltage 58 is applied, e.g. via a pair of fly leads 60, between the clamping electrodes 52 and the tip electrode 54 such that a current passes through the needle 12. The current within the needle results in Ohmic heating of the needle 12, which causes its tip to soften, and subsequently melt. Due to the axial compression 56 applied to the tip electrode during the heating/softening/melting process, the needle 12 is axially deformed and its tip is melted into a blunt ball 62—as shown in
[0064] The heating, softening or melting and deformation of the needle 12 in this way is particularly advantageous because the heat within the needle is sufficient to kill bacteria, pathogens, viruses and other contaminants; whilst at the same time, the axial compression converts the previously sharp tip of the needle 12 into a blunt ball 62—thereby rendering it “safe” from a needlestick injury point of view.
[0065] In other words, by way of the process shown in
[0066] Turning now to
[0067] Turning now to
[0068] At this point, the phlebotomy needle 10 comprises a first end 12, which has been blunted into a ball 62 and an exposed, sharp second end, which also needs to be rendered safe. To achieve this, a melting process, such as that described above in relation to
[0069] However, for convenience, and in order to avoid duplication of parts, the invention proposes to rotate 72 the needle 10 through 180 degrees and to offer it up to the same tip electrode 54 that was used previously. An axal compression 56 and a voltage 58 can be applied to melt the second end 16 of the needle 12 into a blunt ball 63, as shown in
[0070] However, if the clamping electrodes 52 are used as they were before, namely gripping the first end 14 of the needle, 12, then it has been found that the epoxy bead, which bonds the hub 18 to the needle 12 can burn due to the heating of the needle during the softening/melting process.
[0071] The solution to this problem, as proposed by the invention, it so re-grip the needle at a second position. That is, the needle 12 is clamped at its second end 16, close to the hub 18, and this involves simply opening up and then reclosing 74 the clamping electrodes 52 so as to grip the needle 12 on its second end 16, rather than at its first end 14. The effect of this is that the electric current pathway does not pass through the part of the needle 12 which is surrounded by the hub 18, and so heating of the hub 18 is minimised.
[0072] The result is shown in
[0073] Next, as shown in
[0074] It will be appreciated from the foregoing description that the invention provides a means for safely disposing of phlebotomy needles 10 in a manner that has hitherto not been contemplated.
[0075] A variation of the phlebotomy needle destruction method described in relation to
[0076] Here, as can be seen in
[0077] Referring now to
[0078] As shown in
[0079] Turning now to
[0080] Once both ends of the needle have been melted into respective, blunt balls, 62, 63, the tip electrodes 54 can be withdrawn 78 and the clamping electrodes 52 retracted 76 thereby freeing/releasing the needle 12 for subsequent disposal in a waste stream 80, as previously described.
[0081] A yet further variation of the needle destruction method previously described is shown in
[0082] The difference here is that voltages V1 and V2, 58 are applied simultaneously such that both ends 12, 14 of the needle 12 are melted into the respective blunt balls 62, 63—as shown in
[0083] Because the potentials of both sets of the clamping electrodes 52 are the same, there is very little, or zero current flowing through the needle 12 in the region of the hub, and this avoids, or reduces the likelihood of the hub getting too hot or catching fire during the process.
[0084] In a yet further possible embodiment of the invention, voltages V1 and V2 are pulsed, and are applied alternately such that only one of the aforesaid current paths is in operation at any given moment in time. This also avoids current passing through the needle in the region of the hub, thereby potentially causing the hub 18 to heat and/burn and this is a further possible benefit of the invention.
[0085]
[0086] Meanwhile, a hub grip 216 is provided, which is mounted at the centre of a bevel gear 218, which is driven for rotation by a complementary bevel gear 220 and by a motor 222.
[0087] On the opposite side of the hub grip 216 to the carriage 208, there is provided a set of clamping electrodes 52, which can be moved towards each other so as to clamp the needle 12 in use.
[0088] A tip electrode 54 is also slidingly mounted on the slide rail 202 and is driven by a second pulley system 214 so that it can be moved along the slide rail 202 as indicated by 54′.
[0089]
[0090] It can be seen, from
[0091] Other means for reorienting the cradle 210 could be provided. In certain embodiments, the means for reorienting the cradle 210 comprises mounting the cradle 210 on an axle or other pivot, which is driven by a DC or stepper motor so that it can be inverted.
[0092]
[0093] Referring to
[0094] Referring to
[0095] It will be appreciated that the same, or different, racks 224 can be used to actuate either gear 218, 222 and so effect independent or co-ordinated rotation of the cradle 210 and turntable 212, as required. In other embodiments, the axles 216, 220 are directly driven, for example, by motors.
[0096] The sequence of operation of the apparatus 200 is shown in
[0097] In
[0098] As shown in
[0099] Referring now to
[0100] Next, as shown in
[0101] As shown in
[0102] The next stage in the procedure, as shown in
[0103] The carriage 208 can now be retracted 316 to the position shown in
[0104] Advancing 320 the carriage 208 again results in a configuration shown in
[0105] The next stage in the process involves retracting 222 the carriage 208 once again so as to separate the rubber cover 16 (now gripped by the clamping electrodes 52) from the second end of the needle 12, as shown in
[0106] Meanwhile, the tip electrode 54 is advanced 324, once the clamping electrodes 52 have been re-opened, so as to push/eject 326 the rubber cover 16 into another waste bin (not shown).
[0107] The procedure continues by the carriage 208 being advanced 326 once again so that the second end of the needle 12 lies between the clamping electrodes 52, as shown in
[0108] As shown in
[0109] The final stages of the procedure are shown in
[0110] The invention is not restricted to the details of the foregoing embodiment(s) which are merely exemplary. For example, a containment cylinder or a heated containment cylinder may be placed around the needle during its axial compression to prevent it from buckling under the application of an axial stress; and the order of the processing steps may be altered without departing from the scope of the invention. Further, whilst one embodiment of the invention has been described, which uses a linear actuator and a turntable, this is just an example, and is not limiting of the invention. For example, the same or a similar process may be performed using a carousel—or other type of arrangement, where each processing step is carried out in sequence, at different positions. The materials and any dimensions mentioned herein are exemplary only and are not necessarily intended to limit the scope of this disclosure, except where necessary for a particular function to work.