WO2021038197A1

WO2021038197A1 - Improvements to medical devices

Info

Publication number: WO2021038197A1
Application number: PCT/GB2020/051977
Authority: WO
Inventors: John SPOFFORTH; Peter Rees; Richard Green
Original assignee: Msc Technologies Limited
Priority date: 2019-08-23
Filing date: 2020-08-19
Publication date: 2021-03-04
Also published as: GB201912135D0

Abstract

The figures show a syringe assembly (10) in accordance with the present invention having a needle device (12) and a protective sleeve 14. Protective sleeve (14) has a substantially cylindrical hollow body (16) open at one end (18) and closed at the other (20). Cylindrical body (16) defines a chamber (22) having an inner chamber wall (24) and outer wall (26). The open end (18) has a longitudinal open slot (28) on one side of the cylindrical body (16) extending from the open end (18) towards the closed end (20) and which terminates approximately halfway along the length of the sleeve (14). The profile of the slot (28) narrows toward the open end (18) forming two retention tabs (30, 32) that engage with the needle device to retain it in place when desired.

Description

IMPROVEMENTS TO MEDICAL DEVICES

The present invention relates to medical devices, and more particularly needle devices, such as hypodermic needles and syringes. Hypodermic needles, syringes and the like have long presented a medical hazard to their users. This is on account of the presence of a sharp point at the end of a needle intended to pierce/puncture a subject's skin to deliver the contents of a syringe or to obtain a sample, for example.

Healthcare workers and patients using such devices are potentially at risk from exposure to, for example, bacteria, viruses, prion proteins, blood, body fluids or the like. Whilst not all blood or body fluids are potentially infective, it is advisable that precaution be taken to reduce the risk of infection as exposure to blood or potentially infectious body fluids may result in the transmission of blood borne viruses (BBVs) which include, HIV, Hepatitis, CJD, amongst many other things. Following the European Council Directive 2010/32/EU the UK designated implementer, the HSE, produced the Health and Safety (Sharps Instruments in Healthcare) Regulations part of which included the legal position that required the substitution of traditional unprotected sharps with a 'safer sharp' when reasonably practicable. The European Union Council in adopting rules for the prevention of sharps injuries state that there are one million plus of such injuries in Europe per annum. The rules were adopted as law by the member states in Further, the environment in which the procedure requiring such devices occurs may not be sterile and inadvertent contamination of the needle, for example, by bacteria and/or viruses from the surrounding environment may occur and be inadvertently introduced into a patient. It is therefore advantageous to manage the sterility and/or health risk of the needles of such devices to patients using such devices themselves, but also healthcare workers.

In accordance with a first aspect of the present invention, there is provided a syringe assembly comprising a needle device and a protective sleeve, the needle device having a body upon which a needle can be mounted and wherein the protective sleeve comprises a housing defining a chamber open at one end for receiving the needle and at least a portion of the needle device body; wherein the assembly comprises locking means for locking the protective sleeve and the needle device in a locked configuration whereby that the needle can be located within the housing and the sleeve cannot be removed. The present invention thus provides a means for protecting against sharps injuries before, during or after a procedure when a needle device is not being used. Any "ooze", i.e. a droplet of blood or bodily fluid that drips from the end of the needle after an injection due, for example, to the release of pressure on a rubber bung in a cartridge-based needle device is completely and safely contained within the protective device if the needle device is received therein. Furthermore, any "spatter" i.e. any aerolisation of blood or bodily fluids caused by the use or engagement of the protective device (i.e. the vibration of a needle caused by the action of engaging the device) is also safely contained within the protective device and cannot enter the atmosphere or land on other instruments, for example. The present invention may satisfy the requirements of International Standard, ISO 23907, and particularly the requirements for a pocket collector as defined in ISO 23907:2012 (E) 3.12 and/or any similar or equivalent standard.

The housing may comprise a substantially cylindrical body having a substantially cylindrical chamber, said chamber defined by a chamber wall having a closed end and an open end to receive the needle device. The chamber of the protective sleeve and the needle device body may be complementarily shaped such that a liquid impermeable seal may be formed between the needle device body and chamber wall when the needle device is in a locked configuration with the protective sleeve. The locking means may comprise at least one pair of mating members. The mating members may comprise a male member and a female member. The male member may be disposed on one of either the needle device or the protective sleeve, whilst the female member is disposed on the other.

Advantageously, the male member is disposed on the needle device whilst the female member is disposed on the protective sleeve.

The assembly may comprise two or more pairs of mating members.

The male mating member may comprise a protrusion that extends from the needle device body and is located proximal to the needle when mounted.

The female mating member may comprise a complementarily shaped recess or aperture in the housing of the protective sleeve. The location of the female member is such that when locked with the male member, a needle mounted on the needle device is located within the chamber of the housing thus preventing sharps injuries.

The profile of the male member may be such that insertion of the needle device is facilitated up to the point of engagement of the mating pair at which point withdrawal is impeded and/or prevented.

The male member may comprise a protrusion. The protrusion may have a free end having a planar face. The planar face may be parallel, substantially parallel or inclined with respect to the longitudinal axis of the needle device. Advantageously, the planar face may be inclined away from the needle end of the needle device forming a barb to impede extraction of the needle device once in a locked configuration with the protective sleeve.

The male member may comprise a radially extending post, extending perpendicularly to the longitudinal axis of the needle device, having a cylindrical body. Advantageously, the free end has an inclined end wall with respect to the end of the needle device proximal to the needle when mounted.

The male member is advantageously a cylindrical wedge. More advantageously, the inclined end wall of the cylindrical wedge is inclined away from the end of the device proximal to the needle, when mounted.

The female member may comprise a complementarily shaped recess or aperture to receive the male member. The barb shape of the male member facilitates movement of the needle device within the housing toward the female member. Once the male member engages the female member, the barb profile impedes the extraction of the needle device.

The assembly may comprise two pairs of mating members. Advantageously, the male members are disposed on the needle device and the female members are disposed on the protective sleeve.

The protective sleeve may comprise locked configuration indication means to indicate when the locked configuration has been achieved. This will enable users to know that the assembly can be safely handled without fear of disengagement and thus sharps injury. The indication means may be visible to the user during use.

The inclined end wall of the post may have a distinctive colour which can be viewed through the aperture provided as the female member in the protective sleeve.

The male member may be disposed on the protective sleeve and the female member disposed on the needle device. The chamber is preferably sized to cause deformation of the needle within the chamber by abutting and then being deformed against the end wall of the chamber by insertion and then displacement of the needle device toward the end wall of the protective sleeve.

In an embodiment, the needle device is capable of penetrating a substrate and establishing fluid communication between the needle device and the substrate for transfer of fluid therebetween. The protective sleeve and the needle device may be fabricated from any suitable material. The protective sleeve and/or needle device may be fabricated inexpensively from a suitable synthetic polymer.

The protective sleeve may comprise a single piece cylinder moulding. In an embodiment, the housing comprises an elongate substantially cylindrical body closed at one end. This closed end may be adjacent to and covers the sharp point of the needle when it is either temporarily parked or permanently contained and/or degraded within the protective sleeve.

The opening for receiving the needle and at least a portion of the needle device body comprises a wide elongated opening complementarily shaped to receive the syringe needle and needle device body.

In an embodiment, the protective sleeve has an open ended slot communicating with the open end of the protective sleeve to facilitate easier location of a needle device in use. The slot may be shaped to provide two retention members for engaging with a needle device body and retaining the needle device in a desired configuration with the protective sleeve, for example, whilst temporarily parked. The retention members grip the body of the needle device so that disengagement of the protective sleeve and the needle device is unlikely to occur unless sufficient force is imparted to separate the two.

The wallof the housing proximal to the open slot may be thicker with respect to the thickness of the remainder of the wall of the housing, and as such may act as a circular spring that the needle device can open as it is pressed down and then pass through it into the housing where it is firmly gripped by the then closing spring. The protection sleeve may comprise support means for supporting the device in a suitable position for use and to assist in maintaining correct orientation and ease of use. The support means may comprise one or more support members.

The one or more support members may comprise a flattening of one side of the housing to form a base, one or more rails and/or any suitable structure for maintaining the orientation of the protective sleeve with respect to a surface on which it may rest.

The one or more support members may comprise a rail extending longitudinally with respect to the protective sleeve's longitudinal axis. The one or more support members may alternatively or additionally comprise extending rail extending transversely with respect to the protective sleeve's longitudinal axis. Suitably the support means may comprise one or more longitudinal and transverse rails. More suitably, the support means comprises two spaced apart longitudinal rails and two spaced apart transverse rails. More suitably, the transverse rails are located adjacent to the retaining means at the distal open end of the protective sleeve. The support means assists in one handed use of a needle device and the protective sleeve mitigating any potential movement of the protective sleeve relative to the needle device during use.

The closed end of the housing is puncture proof with respect to a needle. As a consequence, when a needle device bearing a needle is inserted into the protective sleeve and sufficient force is exerted by a user to displace the needle device in a direction toward the closed end, the tip of the needle will abut the closed end wall. If a user exerts further force, the needle will deform and the needle device body extend further into the chamber to the point at which the locking members engage with one another and co-operate to lock the needle device in a locked configuration with the protective sleeve.

The protective sleeve thus acts as a mini-sharps container for the needle device which can then be safely disposed without the need of the use of a separate sharps container and thus provides a safe, cost effective solution.

In an embodiment the housing may be tapered towards its closed end to aid in permanent retention of the needle device when in this configuration.

The needle device may include a syringe body to which a needle may be affixed.

The needle device may comprise one or more guide members to help guide the cartridge into the chamber and correct alignment. The one or more guide members may further comprise cartridge retention means.

In accordance with a further aspect of the present invention, there is provided a needle device as described hereinabove for delivering a hypodermic injection comprising a chamber for receiving a cartridge containing a fluid having at one end a diaphragm intended to be punctured to permit the fluid to be delivered, wherein the device comprises means to effect aspiration capable of interacting with the diaphragm of the cartridge such that aspiration can occur.

In accordance with a further aspect of the present invention, there is provided a device for delivering a hypodermic injection comprising a housing having i) A chamber to receive a cartridge containing fluid and having a moveable bung, ii) a plunger axially movable and in use capable of interacting with said bung to move it, said plunger having resiliently deformable means for engaging with said bung. In accordance with a further aspect of the present invention, there is provided a needle device as described hereinabove.

In accordance with a further aspect of the present invention, there is provided a protective sleeve as described hereinabove. In accordance with a further aspect of the present invention, there is provided a kit of parts comprising a needle device as described hereinabove and/or a protective sleeve as described hereinabove, together with a needle.

The present invention will now be described by way of example only with reference to the accompanying figures, in which: Fig. la shows an assembly in accordance with the present invention;

Fig. 1 b is a sectional view of the assembly shown in Fig. la;

Fig. 2 shows a protective sleeve in accordance with the present invention from above;

Fig. 3 a shows the protective sleeve of Fig. 2 from below;

Fig. 4 shows an end elevation of the protective sleeve of Figs. 2 and 3; Fig. 5 shows a needle device in accordance with the present invention;

Fig. 6 shows a sectional view of a protective sleeve in accordance with the present invention;

Fig. 7 shows an expanded view of a needle device partially docked in a protective sleeve in accordance with the present invention; Fig. 8 shows the needle device and protective sleeve of Fig. 7 in a locked configuration; Fig. 9 shows a plunger rod in accordance with the present invention; and

Fig. 10 shows an embodiment in accordance with the present invention.

The figures show a syringe assembly 10 in accordance with the present invention having a needle device 12, needle 13 and a protective sleeve 14. Protective sleeve 14 has a substantially cylindrical hollow body 16 open at one end 18 and closed at the other 20. Cylindrical body 16 defines a chamber 22 having an inner chamber wall 24 and outer wall 26. The open end 18 has a longitudinal open slot 28 on one side of the cylindrical body 16 extending from the open end 18 towards the closed end 20 and which terminates approximately halfway along the length of the sleeve 14. The profile of the slot 28 narrows toward the open end 18 forming two retention tabs 30, 32 that engage with the needle device to retain it in place when desired.

The other surface of the cylindrical body 16 has two spaced longitudinally extending rails 34, 36. Towards the open end 18 and adjacent to the retention members 30, 32 is a transverse rails 38. During use, the protective sleeve 14 may be placed upon a surface, such as a table, and the rails assist in maintaining the orientation of the sleeve 14 with respect to the surface and in so doing presents the open slot for a user to more readily locate and dock the needle device 12.

When the protective sleeve is resting on its rails, the inner chamber wall has an upper 42 and lower section 44. The upper and lower sections are complementarily shaped with respect to the needle device 12 having grooves 40, 40' disposed therein and shaped to receive the needle device 12. The needle device 12 has an elongate cylindrical hollow body 50 having an elongate slot 52 centrally disposed and extending along a substantial portion of its length. The needle device 12 has one end 54 proximal to a needle when connected and possessing a needle mount 56 and a distal open end 58, with respect to a needle when connected. The distal open end 58 is shaped to accommodate a cylindrical cartridge carrying fluid to be dispensed via the needle device 12 and permit insertion into the device 12 and subsequently a syringe plunger rod 90.

The elongate slot 52 has a proximal end 62, adjacent the proximal end 54 of the needle device and a distal end 64, adjacent to the distal end of the device. Adjacent to the proximal end 62 of the elongate slot 52 are retaining members 66, 66' capable of gripping a cylindrical cartridge when loaded. Adjacent to its distal end 64 are located another two retaining members 68, 70 which are also capable of gripping a cylindrical cartridge when loaded into the needle device 12. The retaining members are particularly useful when using cartridges of varying lengths to ensure that they are held in a desired position. The retaining members 66, 66', 68, 70 are flexible so that deformation of the needle device body 50 in a direction away from the wings will result in the easy facilitation of cartridge removal, if desired. This is particularly useful when the product is being disposed of so that recycling or suitable waste management is better achieved.

The needle device body 50 further includes two flanges, 72, 74 extending perpendicularly to the longitudinal axis of the device to provide an area for the index finger and middle finger to grasp during administration.

The needle mount 56 comprises a longitudinally extending cylindrical nipple 76 having a screw thread 78 extending around its circumference. In fluid communication with the needle mount 56 is a perforator 79 for perforating the diaphragm on a cartridge to permit the flow of fluid from a cartridge through the perforator and into the lumen of a mounted hypodermic needle, for example.

At the proximal end of the needle device body 50 are located two radially extending protrusions 80, 82 disposed diametrically opposite one another and extending perpendicularly to the longitudinal axis of the body 50. The protrusions are cylindrical wedges having an inclined end wall 84, 84'. The inclined end wall is inclined away from the proximal end 54 of the needle device 12 to facilitate insertion of the needle device 12 into the protective sleeve 14. The protective sleeve 14 has two circular through going bores 46, 46' extending between the inner and outer wall of the chamber. The position of these through going bores or apertures 46, 46' conforms to the desired orientation of the needle device 12 when in a locked configuration and are complementarily shaped with respect to the cross section of the protrusions 80, 82. The distal end 84 of the inclined face of the end wall of the protrusions 80, 82 act like barbs to prevent the protective sleeve 14 from being removed once the protrusions 80, 82 are located within the apertures 46, 46' and pass through the apertures 46, 46' of the protective sleeve 14.

The inclined end wall of the protrusions 80, 82 have a distinctive appearance and are coloured to provide a visible indication to a user that the protective sleeve 14 and the needle device 12 are in a locked configuration as the coloured end wall will be visible through the apertures 46, 46'. Furthermore, the protective sleeve 14 and the needle device

12 each have an arrow 100, 100' disposed on their bodies in a distinctive colour so that an operator may use the arrows to align the needle device 12 correctly with the protective sleeve 14 for docking and subsequently locking together.

In addition, positive feedback is given to the user as the profile of the upper and lower sections 42, 44, protrusions 80, 82 and apertures provide detectable physical feedback when the protrusions are correctly located within the apertures indicating the locked configuration has been achieved.

The plunger rod 90 has a thumb press 92 and an elongate shaft 94 extending therefrom having a free end 96 to engage with a cartridge to facilitate administration.

In use, it should be remembered that medical and dental operatives are used to putting the needle sheath, on its removal from the needle just prior to injection, in a set position for subsequent retrieval. However this time the technique used is single-handed.

Thus when the protective sleeve is taken from the needle device, e.g. syringe, it is placed in the same convenient position as would be the sheath, that is directly where the operatives hand would fall as the syringe and attached needle is removed from the patient. For health and safety reasons it is advisable not to stand or walk about with an exposed needle in the operative's hand. The operative should be in such a position that the operative is not required to walk to the protective sleeve.

On giving the injection the operative with one hand takes the contaminated syringe to the protective sleeve which is in close proximity. The needle is passed through the loading opening and should touch its upper front end with the upper needle face. This prevents the needle tip touching the inner surfaces of the protective sleeve. The needle hub is pushed forwards until it is approximately 3mm from the front edge of the opening. With the index finger the operative presses 30, 32straight down on the needle hub. This action in pushing through the slot causes the clip to open and the needle device passes through. As this happens the clip closes above the needle device body 50 and it is temporarily retained by the clip friction. If a top up injection is subsequently required it is simple to unclip the protective sleeve with one hand, putting it in the same recovery position as before, giving the injection and then recovering it as with the primary injection. This can be repeated.

Replacing a cartridge is as simple, but only done in those countries where it is permitted. The needle remains covered and protected during this procedure. When the injection is to be given with the new cartridge, it is removed as for a top up injection.

When satisfied that all injections are complete, and this could of course be the first injection, the protective sleeve is then raised into a vertical orientation and the needle device and needle are pressed down vertically into the protective sleeve with the front end placed on a firm surface. The needle device passes forwards further into the protective sleeve, the needle point strikes the puncture proof forward end of the protective sleeve and bends in such a way that the needle is degraded to such an extent that it is unusable.

The protrusions on the needle device mate with apertures 46, 46' of the protective sleeve and the proximal end 54 of the needle device abuts the internal taper of the chamber. The combination of these two lock the needle device, protective sleeve together and disabled needle permanently into the front chamber of the protective sleeve.

The shaft 94 of the plunger 90 has a cruciform transverse section. At its free end 96 are four leaves 98 in a substantially cruciform arrangement. The leaves 98 of the plunger are resiliently deformable such that they can be deflected when pushed against a cartridge. Cartridges used for device such as those described in the present invention typically have an elongate hollow cylindrical body at one end having means for engaging with a perforator of a needle device at the needle mounting end of a syringe and at the other, distal, end a recess in which is inserted a plug which a plunger rod will engage. Around the internal circumference of the cartridge body's distal end is a small lip which extends inwardly towards the centre of the cartridge body. The lip is formed during manufacture as the cylindrical body is formed. Consequently, the plunger rod has to be of a smaller diameter than the lip of the cartridge body. In known devices, in practice this requires there to be a separate deformable collar to be applied to the end of the plunger rod so that the plunger rod can be used to deliver the cartridge's contents.

The plunger rod of the present invention can be formed as a single piece reducing the manufacturing and assembling costs associated with such devices. The plunger rod of the present invention has resiliently deformable leaves which extend slightly beyond the internal circumference of the lip of a cartridge and can thus be pushed therethrough. The leaves will then attempt to conform to their original shape and push against and be retained by the circumferential lip. In this way the rod is held in place and can be depressed and retracted. When used with a dental cartridge the needle device is designed to allow not only the initial loading but also any subsequent top-up injections that can involve the cartridge to be changed one or more times.

To reload a cartridge, the cruciform leaves 98 of the plunger rod 90 provide sufficient grip on a complementarily shaped rear end of a cartridge that displacement of the plunger rod

90 in a direction away from the proximal end of the needle device results in the withdrawal of the cartridge from the needle device body. Once removed, a replacement cartridge may be loaded from the distal end of the needle device, and the the plunger rod used to displace the cartridge toward the proximal end of the needle device until reloading has been completed. Once the assembly has been locked, the plunger rod 90 may be separated from the assembly and recycled whilst the other components of the assembly disposed of safely as any other sharps container. Thus the carbon footprint of the assembly in comparison to other sharps containers is further reduced.

In an embodiment (Fig. 10) there is a syringe assembly 200 in accordance with the present invention having a needle device 212, needle 202 and a protective sleeve 214. The protective sleeve is as described hereinabove. The needle device differs from the needle device shown in the other figures in the absence of retaining members 68, 70. Rather the embodiment shown in Fig. 10 has an extension of the side wall 220 of the distal end 222 of the needle device 212. The lengthening if the side wall 220 shortens the elongate slot 224 and provides means of engaging with cartridges of varying lengths in a similar fashion to retaining members 68, 70 to help retain the cartridges of varying length in situ during use.

Those of skill in the art will understand that modifications (additions and/or removals) of various components of the substances, formulations, apparatuses, methods, systems, assemblies and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

Claims

1. A syringe assembly comprising a needle device and a protective sleeve, the needle device having a body upon which a needle can be mounted and wherein the protective sleeve comprises a housing defining a chamber open at one end for receiving the needle and at least a portion of the needle device body; wherein the assembly comprises locking means for locking the protective sleeve and the needle device in a locked configuration whereby that the needle can be located within the housing and the sleeve cannot be removed.

2. An assembly as claimed in claim 1 wherein the housing comprises a substantially cylindrical body having a substantially cylindrical chamber, said chamber defined by a chamber wall having a closed end and an open end to receive the needle device.

3. An assembly as claimed in claim 1 or 2 wherein the chamber of the protective sleeve and the needle device body may be complementarily shaped such that a liquid impermeable seal may be formed between the needle device body and chamber wall when the needle device is in a locked configuration with the protective sleeve.

4. An assembly as claimed in any one of the previous claims wherein the locking means may comprise at least one pair of mating members.

5. An assembly as claimed in claim 4 wherein the mating members may comprise a male member and a female member.

6. An assembly as claimed in claim 5 wherein the male member may be disposed on one of either the needle device or the protective sleeve, whilst the female member is disposed on the other.

7. An assembly as claimed in claim 6 wherein the male member is disposed on the needle device whilst the female member is disposed on the protective sleeve.

8. An assembly as claimed in claim 7 wherein may comprise two or more pairs of mating members.

9. An assembly as claimed in claim 7 or 8 wherein the male mating member may comprise a protrusion that extends from the needle device body and is located proximal to the needle when mounted.

10. An assembly as claimed in claim 9 wherein the female mating member may comprise a complementarily shaped recess or aperture in the housing of the protective sleeve.

11. An assembly as claimed in any one of claims 5 to 10 wherein the male member may comprise a protrusion having a inclined surface with respect to the needle end of the needle device forming a barb to impede extraction of the needle device once in a locked configuration with the protective sleeve.

12. An assembly as claimed in any one of claims 5 to 11 wherein the male member is advantageously a cylindrical wedge.

13. An assembly as claimed in claim 12 wherein the inclined end wall of the cylindrical wedge is inclined away from the end of the device proximal to the needle, when mounted.

14. An assembly as claimed in claim 13 wherein the female member may comprise a complementarily shaped recess or aperture to receive the male member.

15. An assembly as claimed in claim 14 wherein the protective sleeve may comprise indication means to indicate when the locked configuration has been achieved.

16. An assembly as claimed in claim 15 wherein, the indication means may be visible to the user during use.

17. An assembly as claimed in any one of the previous claims wherein the housing comprises an elongate substantially cylindrical body closed at one end.

18. An assembly as claimed in any one of the previous claims further comprising support means for supporting the device in a suitable position for use and to assist in maintaining correct orientation and ease of use.

19. An assembly as claimed in claim 18 wherein the support means may comprise one or more support members.

20. An assembly as claimed in claim 19 wherein the one or more support members may comprise a rail extending longitudinally with respect to the protective sleeve's longitudinal axis.

21. An assembly as claimed in claim 20 wherein the support means further comprises one or more transverse rails.

22. An assembly as claimed in claim 21 wherein the support means comprises two spaced apart longitudinal rails and two spaced apart transverse rails.

23. An assembly substantially as described herein with reference to and as illustrated in the accompanying drawings.