SYRINGE APPARATUS AND SYRINGE ADAPTER DEVICE
20230129857 · 2023-04-27
Inventors
Cpc classification
A61M5/3137
HUMAN NECESSITIES
A61B5/153
HUMAN NECESSITIES
A61B5/150259
HUMAN NECESSITIES
A61M2005/3139
HUMAN NECESSITIES
International classification
Abstract
A syringe apparatus (10) is provided which comprises a syringe portion having a syringe (12) or holder (24) adapted to receive a syringe (12) therein, the syringe portion having a rear grip (38) for seating in or against a user's hand and a front grip (40) formed at or adjacent to a tip end (22) of the syringe portion; and a movable member (30) engagable with a plunger (16) of the said syringe (12), the movable member (30) having a finger grip (32) at or adjacent to a tip end (22) thereof, the movable member (30) being engaged with the syringe portion and configured to move relative to the rear grip when a user applies a force at the finger grip (32); wherein the front and rear grips (40, 38) are formed as lateral projections (40a, 40b; 38a, 38b) with respect to the movable member (30).
Claims
1. A syringe apparatus comprising: a syringe portion having a syringe or holder adapted to receive a syringe therein, the syringe portion having a rear grip for seating in or against a user's hand and a front grip formed at or adjacent to a tip end of the syringe portion; and a movable member engagable engageable with a plunger of the syringe, the movable member having a finger grip at or adjacent to a tip end of the movable member, the movable member being engaged with the syringe portion and configured to move relative to the rear grip when a user applies a force at the finger grip; wherein the front grip and the rear grips are formed as lateral projections with respect to the movable member.
2. The syringe apparatus of claim 1, wherein the movable member is slidably engageable with the syringe portion.
3. The syringe apparatus of claim 1, wherein the movable member is at least in part receivable in a longitudinal channel of the syringe portion.
4. The syringe apparatus of claim 3, wherein the movable member comprises an elongate spine at least in part receivable in the longitudinal channel which interconnects the finger grip with the plunger.
5. The syringe apparatus of claim 4, wherein the finger grip has a width greater than a width of the longitudinal channel.
6. The syringe apparatus of claim 1, wherein the rear grip comprises at least one lateral flange palm grip.
7. The syringe apparatus of claim 6, wherein the rear grip further comprises a second lateral flange palm opposed to the at least one lateral flange palm grip.
8. The syringe apparatus of claim 6 wherein the at least one lateral flange palm grip has a contoured profile.
9. The syringe apparatus of claim 1, wherein the front grip has a lateral extent which is less than or equal to a lateral extent of the rear grip.
10. The syringe apparatus of claim 1, wherein the front grip is angularly oriented to the rear grip.
11. The syringe apparatus of claim 1, wherein the syringe portion comprises a syringe holder, and the movable member is engaged with the syringe holder opposite to a syringe-receiving aperture of the syringe holder.
12. The syringe apparatus of claim 1, wherein the syringe portion comprises a syringe holder, and the movable member is engaged with the syringe holder adjacent to a syringe-receiving aperture of the syringe holder.
13. The syringe apparatus of claim 1, wherein the movable member includes a plunger-connector for receivably coupling to the plunger.
14. The syringe apparatus of claim 13, wherein the plunger-connector comprises a cap receivable around a plunger top of the syringe.
15. The syringe apparatus of claim 13, wherein the plunger-connector comprises a stop abuttably engageable with the syringe holder to limit travel of the engaged plunger.
16. The syringe apparatus of claim 1, wherein the syringe portion comprises a stop at or adjacent to the tip end of the syringe portion.
17. (canceled)
18. The syringe apparatus of claim 1, wherein the syringe portion is a syringe, and the movable member is integrally formed with a syringe body of the syringe.
19. The syringe apparatus of claim 1, wherein the movable member is integrally formed with the plunger.
20. The syringe apparatus of claim 1, wherein the syringe apparatus has a form of a syringe adapter device engageable with a syringe.
21. The syringe apparatus of claim 20, further comprising: a syringe having a syringe body and a plunger receivable in the syringe body, wherein the syringe adapter device is engageable with the syringe, and wherein engaging the syringe with the syringe adapter device allows a user to operate the syringe apparatus with one hand.
22. (canceled)
Description
[0051] The invention will now be more particularly described, by way of example only, with reference to the accompanying drawings, in which:
[0052]
[0053]
[0054]
[0055]
[0056]
[0057]
[0058]
[0059]
[0060]
[0061]
[0062]
[0063]
[0064]
[0065]
[0066]
[0067]
[0068]
[0069] Referring to
[0070] The syringe adapter device 14 is dimensioned to receive a syringe 12 of standard dimensions. Commonly used plastic syringes have volumes of 1 ml, 2.5 ml, 5 ml, 10 ml, and 25 ml, with the 10 ml volume being most commonly used in medical practice for taking blood samples.
[0071] It will be appreciated that whilst the indicative embodiments of the invention are shown as releasably engagable syringes and adapter devices, an integrally formed syringe apparatus could be provided in which the adapter device was inbuilt to the syringe.
[0072] The syringe 12 has a syringe body 18 within which the plunger 16 is receivable, and actuation of the plunger 16 with respect to the syringe body 18 changes the internal volume of the syringe 12 to either expel the contents of the syringe 12 through the syringe outlet 20 at a tip end 22 thereof, or alternatively draw matter into the syringe body 18 on retraction of the plunger 16. This is the context in which the syringe apparatus 10 might be used for taking blood samples.
[0073] The syringe adapter device 14 comprises a syringe holder 24 which has a syringe receiver 26 on one side thereof within which the syringe 12 is insertable. For the syringe adapter device 14, it will be appreciated that the syringe holder forms a syringe portion of the apparatus 10, that is, the area in which the syringe 12 can be located. For the embodiment of the invention described in more detail below, the syringe portion would be the syringe body 18 of the syringe.
[0074] The engagement between the syringe 12 and the syringe adapter device 14 is indicated in
[0075] The syringe holder 24 includes a rear grip 38 which is receivable within the user's hand in use and which the user's palm abuts. Here, the rear grip 38 is provided as a pair of lateral palm grip portions 38a, 38b which oppose one another, having a contoured or curved upper edge for comfort. A single rear grip element may be provided, but the opposed flange portions ensure that the syringe adapter device 14 can be used with either hand with ease.
[0076] Lateral here refers to the fact that that, not only do the palm grip portions 38a, 38b extend in a direction which is perpendicular to the axis of motion of the plunger 16, but also that the palm grip portions 38a, 38b extend in a direction perpendicular to the side on which the finger grip 32 of the movable member 30 is positioned.
[0077] At or adjacent to the tip end 22 of the syringe holder 24 is a front grip 40 which is designed for engagement with a user's finger or thumb, providing forward stabilisation close to the needle point of the syringe 12. The front grip 40 may also be provided as one or more lateral projections, forming right- and/or left-hand front grips 40a, 40b, which are preferably angularly oriented to the lateral palm grip portions 38a, 38b of the rear grip 38. For comfort, the front grip 40 may have a width that is less than or equal to that of the rear grip 38. This orientation of the respective flange portions may simplify the manufacture of the syringe holder 24, for example, if created by injection moulding.
[0078] Again, lateral here refers to the fact that that, not only do the front grip portions 40a, 40b extend in a direction which is perpendicular to the axis of motion of the plunger 16, but also that the front grip portions 40a, 40b extend in a direction perpendicular to the side on which the finger grip 32 of the movable member 30 is positioned.
[0079] This achieves the arrangement of the front and rear grip portions 40a, 40b, 38a, 38b which permits the pencil grip. The front and rear grip portions 40a, 40b, 38a, 38b thus all intersect a nominal horizontal in-use plane of the syringe apparatus 10, which then by extension positions the finger grip 32 of the movable member 30 on a top surface of the syringe apparatus 10.
[0080]
[0081] The movable member 30 is an elongate member, having an elongate spine 46 which is dimensioned to fill or substantially fill the elongate channel 28 of the syringe holder 24 in a compact condition, that is, where the plunger 16 is fully received within the syringe body 18. In the embodiment shown, the plunger-connector 34 is formed as a cap 48 which is receivable about the plunger top 50 of the syringe 12, and a complementarily-shaped recess 52 may be provided in the cap 48 which accommodates both the neck 54 and plunger top 50. The cap 48 itself is preferably designed to envelop the perimeter of the plunger top 50, thereby holding it securely in place. This provides lateral security, so that the plunger 16 does not dislocate from the plunger-connector 34 in use, but also axial securing is or can be provided, to ensure that there is no lag between the movement of the movable member 30 and plunger 16.
[0082] As is best seen in
[0083] The finger grip 32 itself may be dimensioned to overhang the elongate channel 28 on at least one, and preferably both, lateral directions thereof. This may improve the comfort of the use of the finger grip 32, since the user cannot get any part of their finger stuck in the elongate channel 28.
[0084] To engage the syringe 12 with the syringe adapter device 14, the syringe 12 needs to be placed into the syringe receiver 26, with the plunger top 50 being engaged with the plunger-connector 34. Stability of the syringe apparatus 10 may be improved if the syringe outlet 20 is positioned so as to be proximal to the syringe holder 24, as can be seen in
[0085] Once engaged, the finger grip 32 can be used to withdraw the plunger 16, as can be seen indicated by the motion arrow of
[0086] The user grip can be seen in
[0087] The shape of the syringe adapter device 14 is such that the index finger 64a will sit naturally on the finger grip 64a. The middle finger 64b can then be used as a stabiliser, either pressing on or hooking around the right-hand lateral front grip 40a, with the thumb 64c buttressing the left-hand lateral front grip 40b, as well as the syringe body 18 from below. It will be apparent to the skilled reader that the grip configuration will be reversed for the left-handed grip.
[0088] This creates a pencil or pincer grip. To take blood, the user holds the syringe apparatus 10 in one hand, and can then retract the index finger 64a so that the finger grip 32 slides the plunger 16 into the retracted condition.
[0089] Stabilisation of the front grip 40 using the thumb 64c and middle finger 64b will ensure minimal disruption of the needlepoint position when a needle is attached to the syringe, leading to a significant reduction in damage to the patient, particularly to their blood vessels such as veins, during exsanguination.
[0090] Extensive testing as to the stability improvements provided by the syringe adapter device 18 have been conducted.
COMPARATIVE EXAMPLE
[0091] For the comparative study, a 10 ml syringe (BD® Biosciences, 1030 Eskdale Road, Winnersh Triangle, Wokingham, Berkshire, RG41 5TS, United Kingdom) was utilised for a test exsanguination process, using a 21 gauge needle (BD® Biosciences) on a standard phlebotomy training arm (Muttiy Inc., (bangongchangsuo) 9002shi, Shangtangsongzaiyuan, 2qu, 51dong, Minzhijiedao, Baoanqu, Shenzhen, Guangdong, 518131, People's Republic of China), filled with cranberry juice to simulate blood.
[0092] Stability was measured with a Landtek VM6370 High Vibration Meter (Guangzhou Landtek Instrument Co., Ltd, Block C, Kengkou Electronic Base, No. 9 Huaxi Road, Fang Village. Guangzhou, Guangdong 510380, People's republic of China) which measured acceleration, velocity, and displacement of the syringe outlet 20. Connection between the vibration meter and sensor was made with a 15 cm cable provided by the manufacturer. A bespoke adapter for the vibration sensor was 3D printed and attached to the end of the syringe 12 and used for the duration of the experiment which kept the sensor in a fixed and stationary position while the syringe 12 was in use.
[0093] The aim of the experiment was to demonstrate that the use of the syringe adapter device 14 improved stability while taking blood, as well as having the syringe 12 in an easier manual configuration than is traditionally used, that is, with a one-handed configuration rather than a two-handed one. With the vibration meter connected to the syringe 12, the user would insert the needle into e vein site on the phlebotomy arm, after which the vibration meter was set to ‘Hold’. This enabled the highest reading for each monitored variable to be read whilst measurements continued to be taken and recorded.
[0094] After flashback of the simulation blood was seen, the plunger 16 of the syringe 12 was pulled back. Throughout the duration of the drawing of the plunger 16, the highest values for acceleration, velocity and displacement were monitored and recorded. Approximately 5 ml of fluid was drawn into the syringe 12 simulating the typical amount used in a clinical situation for full blood count (FBC) and urea and electrolyte (U&E) testing.
[0095] Thirteen trials were conducted for each of the three syringe configurations used: 1) a syringe 12 with no adapter, using two hands; 2) a modified syringe apparatus as described above, in which the front grip 40 was omitted; and 3) a syringe apparatus as described above, inclusive of the front grip 40.
TABLE-US-00001 TABLE 1 Velocity Acceleration Displacement Control (mm/s) (mm/s.sup.2) (mm) 3.33 0.47 0.272 2.5 1 0.37 3.23 0.1 0.177 3.29 0.1 0.179 3.01 1.4 0.283 3.51 1.3 0.204 4.66 0.4 0.436 3.91 1.3 0.197 4.35 0 0.072 3.11 6.9 0.139 2.76 1.7 0.179 3.07 0.5 0.148 5.23 5.3 0.57 3.21 8.8 0.297 Average 3.782 2.251 0.271 Standard 0.764 2.799 0.133 Deviation
TABLE-US-00002 TABLE 2 Syringe Velocity Acceleration Displacement Apparatus 1 (mm/s) (mm/s.sup.2) (mm) 3.99 0.1 0.079 3.89 0.1 0.098 2.11 1.1 0.078 2.69 0.1 0.162 2.2 0.1 0.184 2.95 4.8 0.28 2.25 0.4 0.136 1.81 0 0.133 2.89 4 0.546 2.61 1.2 0.338 2.77 0.3 0.261 2.46 0.2 0.305 2.25 0.4 0.318 2.98 0.3 0.131 Average 2.912 1.008 0.235 Standard 0.628 1.519 0.131 Deviation
TABLE-US-00003 TABLE 3 Syringe Velocity Acceleration Displacement Apparatus 2 (mm/s) (mm/s.sup.2) (mm) 1.59 0.2 0.169 3.15 1.3 0.133 1.57 0.2 0.115 1.43 0.3 0.186 1.33 0 0.037 1.55 2.3 0.185 2.59 2.3 0.103 2.03 0.6 0.133 1.19 0.8 0.117 2.13 0.4 0.131 1.13 0 0.123 2.23 1.7 0.161 1.75 0.6 0.111 1.66 0.3 0.133 Average 1.948 0.846 0.141 Standard 0.565 0.799 0.038 Deviation
Results
[0096] Subjective results from testing with the syringe apparatuses 1 and 2 (respectively that without the front grip, and that described above and shown in
[0097] Most users also commented on the added stability that a one-handed configuration provides, not simply because the syringe apparatus 10 does not rely on two hands to activate the syringe adapter device 14 with the increased tension needed to operate it, but also that in certain situations where patients may have a resting tremor, having the non-dominant had at or near the venepuncture site also greatly facilitates stability.
[0098] Objective data obtained from an experienced user comparing the three configurations confirmed these subjective results, as outlined above. Velocity decreased for the first syringe apparatus when compared with the control syringe (3.78 mm/s versus 2.91 mm/s). This demonstrates the improvements achievable with the use of the ‘pincer’ grip that is afforded by the present invention.
[0099] Velocity further decreased for the second syringe apparatus 10 when compared with the first syringe apparatus (2.91 mm/s versus 1.94 mm/s) that allows for the use of a ‘trigger’ grip, in which the middle finger 64b hooks over the front grip 40 to hold back the syringe adapter device 14 and urge the rear grip 38 into the palm 62 of the user.
[0100] The velocity improvement for the enhanced syringe apparatus 10 showed a statistically significant deviation, such that the standard deviation bars for the control versus the second syringe apparatus 10 did not overlap.
[0101] Measurement of displacement followed a similar trend. The first syringe apparatus showed an improvement, that is, reduced displacement, over the control (0.234 mm versus 0.363 mm), and a further improvement between the second syringe apparatus 10 and the first syringe apparatus (0.141 mm versus 0.234 mm). Once again, there was no overlap between the standard deviation bars of the second syringe apparatus 10 and the control.
[0102] Statistical t-test analysis of the above study revealed that for velocity testing, all values were significantly different (t<0.05). For displacement testing, there was no statistically significant different in displacement between the first syringe apparatus and control (t=0.556), but a statistically significant difference was seen between the second syringe apparatus 10 and both the first syringe apparatus and control.
[0103] As such, not only does the one-handed syringe arrangement significantly improve stabilisation of the syringe apparatus 10 by reducing any velocity action at the needle point, but with the inclusion of the front grips, also demonstrably reduces displacement, limiting the risk of tearing of the patient's skin or blood vessels.
FURTHER EMBODIMENTS
[0104] Other versions of the syringe apparatus could, however, be considered. A second embodiment of the syringe apparatus is indicated globally at 110 in
[0105] In this embodiment, designed for the same syringe 12, the syringe adapter device 114 comprises a syringe receiver 126 which is positioned on the side of the syringe holder 124, thereby allowing a different means of entry for the syringe 12 therein.
[0106] The movable member 130 may therefore be exposed at or adjacent to the syringe receiver 126, and therefore the elongate spine 144 may not necessarily run in a longitudinal channel.
[0107] To ensure that the movable member 130 and syringe holder 124 do not dislocate from one another, the movable member 130 may be keyed to, or otherwise engaged with the syringe holder 124, to ensure that a smooth plunger 16 motion can be achieved.
[0108] Instead of the nub of the previous embodiment, the finger grip 132 may be formed so as to have a contoured and/or ergonomic portion 136 suited to receiving the tip of a user's index finger.
[0109] Since the syringe receiver 126 is positioned to one side of the syringe holder 124, the syringe apparatus 110 can no longer be used ambidextrously, and a rear grip 138 is only positioned on one side of the syringe holder 124. It will be apparent that a mirror-image syringe apparatus could be provided for left-hand operation.
[0110] The syringe holder 124 may have a forward stop 166, at or adjacent to the tip end 22 of the syringe 12, which may limit travel of the movable member 130 beyond the front of the syringe holder 124. A similar rear stop 168 may be provided at the opposite end of the syringe holder 124, which is engagable with the plunger-connector 134 of the movable member 130. This could be formed as an inner shoulder which slots into the cap 148 of the plunger-connector 134.
[0111] A third embodiment of the syringe apparatus is indicated globally at 210 in
[0112] The syringe adapter device 214 has an elongated syringe holder 224 having an extended longitudinal channel 228 which fully encompasses the travel of the movable member 230. The longitudinal channel 228 therefore itself forms front and rear stops 266, 268 to prevent escape of the movable member 230 and allowing for free movement of the movable member 230 only within the longitudinal channel 228.
[0113] The syringe holder 224 therefore includes an extended rear portion 270 beyond the rear grip 238, which could be useful for resting against a user's arm, further stabilising the syringe apparatus 210. In this case, front grips may not be necessary.
[0114] Various additional embodiments of the movable member are shown in
[0115]
[0116]
[0117]
[0118]
[0119]
[0120]
[0121] As previously noted, whilst a syringe adapter device is disclosed, the present invention is not intended to exclude the possibility of an integrated syringe including the movable member as previously described. To this end, it may be possible to provide a syringe apparatus comprising a syringe having a syringe body, thereby forming the syringe portion as opposed to the syringe holder of the syringe adapter device, and a plunger receivable in the syringe body, and a rear grip for seating in or against a user's palm. The movable member then has a plunger-connector, which may be integrally formed with the plunger itself, for engaging with a plunger and a finger grip at or adjacent to a tip end of the movable member. The movable member is engaged with the syringe body and configured to move relative to the rear grip when a user applies a force at the finger grip.
[0122] The movable member can be integrally formed with, or journaled within, the syringe body so as to slide relative to the syringe body, instead of a separate syringe holder. However, in all other considerations, the method of operation of the movable member is identical to that of a syringe adapter device.
[0123] The advantage of an integrated syringe embodiment is that non-standard volumetric configurations can be considered. The syringe adapter device is suited for compatibility with existing syringes known in the art. However, there are various adaptations to the syringe itself that could be made to improve user comfort in a one-handed grip arrangement.
[0124] In particularly, the elongate nature of the syringes in the art are configured so that they can be readily operated with two hands. However, a shorter syringe with a wider barrel could now be considered, since a second hand is not required in or around the area of the syringe body. As such, a squat syringe with an integrally formed movable member engaged with the plunger could be provided.
[0125] It is therefore possible to provide a syringe or an adapter therefor which allows the plunger action to be performed with one hand. This can be achieved by providing a movable member engaged with the plunger, and which is positioned for operation by an index finger of a user holding the syringe in a pencil or pincer grip. This is completely different to the two-handed operation necessitated with syringes in the art.
[0126] The words ‘comprises/comprising’ and the words ‘having/including’ when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components, but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. The embodiments described above are provided by way of examples only, and various other modifications will be apparent to persons skilled in the field without departing from the scope of the invention as defined herein.