WO2017058079A1

WO2017058079A1 - Needle tip shielding device and fixing arrangement

Info

Publication number: WO2017058079A1
Application number: PCT/SE2016/050894
Authority: WO
Inventors: Per Knutsson
Original assignee: Vigmed AB
Current assignee: Vigmed AB
Priority date: 2015-09-30
Filing date: 2016-09-22
Publication date: 2017-04-06
Anticipated expiration: 2018-03-30

Abstract

A protective covering (100) for human skin application is provided. The covering comprising two lateral sections (102) and a central section (104), wherein at least the two lateral sections (102) are skin adhesive on their proximal sides, wherein the central section (104) comprises a silicone layer (104) and is adhesive to plastic or metal on its distal side.

Description

NEEDLE TIP SHIELDING DEVICE AND FIXING ARRANGEMENT

FIELD OF THE INVENTION

The present invention pertains to a protective covering for human skin application, said covering comprising two lateral sections and a central section. The invention also pertains to a method for the use of a protective covering and a syringe. The invention also discloses a kit of said protective covering and a syringe,

BACKGROUND OF THE INVENTION

Hypodermic syringes and hypodermic needles to inject remove liquid or gases into body tissues. However, the use of a medical syringe is associated with several risks. Bloodborne diseases such as hepatitis B, hepatitis C and HIV/AIDS can be transmitted through unsafe injections due to poor injection practices and injection overuse. According to WHO, a safe injection does not harm the recipient, does not expose the physician to any risk and does not result in waste that is dangerous for the community. To achieve this, the injection needs to be administered using a sterile syringe and needle. After administration, sharp equipment needs to be discarded in a puncture-proof container for appropriate disposal.

This is a substantial problem, and according to WHO (World Health

Organization), the diseases frequently transmitted through unsafe injections are hepatitis B (estimated 21 million cases anually), hepatitis C (estimated 2 million cases anually) and HIV/AIDS (estimated 260 000 cases anually).

Hygiene practices during the injecting procedure are also essential, and unhygienic injections can cause abscesses and lead to septicaemia.

In recent years, there has been great concern over the contamination of clinicians with a patient's blood and a recognition that "blood contaminated sharps" must be disposed to avoid an accidental needle stick. This concern has arisen because of the advent of currently incurable and fatal.

As a result of the problem of accidental needlesticks by "blood contaminated sharps", various needle shields have been developed for use in conjunction with intravenous catheters.

In the field of medicine, such as within the field of devices for injection, it is known to arrange needle tip shielding devices on the injection or infusion needle, said shielding device being a pivoting shield, that is swung in front of the needle after use. US5242417 discloses a needle cover of this kind. However, this kind of needle cover demands that the needle cover is activated after use. It is hence not automatically covered after injection. This means that the user may prick oneself during activation or if the patient jerks upon injection.

However, many injections are made in regions where there is widespread reuse of syringes and needles and or lacking hygienic facilities.

Thus, there is a need for building safe and appropriate products and methods for safe injections, especially single-use injection devices that are simple and safe enough to be available in every health care facility, and that allows for an automatic covering of the needle tip once injection has been initiated.

SUMMARY OF THE INVENTION

It is an object of the present invention, considering the disadvantages mentioned above, to provide a protective covering for human skin application, said covering comprising two lateral sections and a central section, wherein at least the two lateral sections are skin adhesive on their proximal sides, wherein the central section comprises a sealing layer and is adhesive to plastic or metal on its distal side: an injection system comprising the protective covering according to above and a syringe, said syringe comprising a barrel, a plunger, a needle, and a needle shield, said needle comprising a needle bulge, a needle shaft, and a needle tip, wherein the needle bulge is located on the shaft of the needle away from the needle tip, and said needle shield is located on the needle shaft between the barrel and the needle bulge: a kit comprising the two above: as well as a method for use of a protective covering according to above, comprising the steps of; i. disinfecting an area suitable for injection on the patients skin, ii. attaching the protective covering to said disinfected area, iii. opening the protective covering cover flap, iv. injecting or drawing blood from the patient using a syringe and needle through the central section of the protective covering, and v.

returning the cover flap to its closed position.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which the invention is capable will be apparent and elucidated from the following description of non-limiting embodiments of the present invention, reference being made to the accompanying drawings, in which

Figure 1 illustrates schematic views of a protective covering;

Figure 2 illustrates detailed views a protective covering;

Figure 3 illustrates schematic views showing the use of an injection system comprising a protective covering and a syringe comprising a needle and a needle shield; Figure 4 illustrates detailed views of an injection system showing the interaction between the protective covering and the syringe needle and needle shield;

Figure 5 illustrates sterilized kits, comprising a protective covering and a syringe with a syringe needle and needle shield, or comprising a protective covering, a syringe, a syringe needle, a needle shield and a disinfectant; and

Figure 6 illustrates injection systems comprising a protective covering and a syringe comprising a needle, a needle shield held by a resilient mechanism, such as a spring mechanism.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Embodiments of the present invention will be described in more detail below with reference to the accompanying drawings in order for those skilled in the art to be able to carry out the invention. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

Furthermore, the terminology used in the detailed description of the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. More specifically, the term "proximal" refers to a location or direction of items or parts of items, during normal use of a protective covering and syringe disclosed herein, is closest to the patient, and farthest away from the clinician. Similarly, the term "distal" refers to a location or direction of items or parts of items, during normal use of the protective covering and syringe disclosed herein, which is closest to the clinician and farthest away from the patient. The term "laterally" refers to the direction away from the central axis of the syringe and the protective covering, wherein the central axis coincides with the proximal and distal vectors.

As can be seen in Figure 1 , the invention relates to a protective covering 100 for human skin application. The protective covering 100 has at least two lateral sections 102, and a central section 104. The central section 104 comprises a silicone rubber layer 104 and is adhesive to plastic or metal on its distal side. A silicone rubber may comprise polymers made up of repeating units of siloxane, which is a functional group of two silicon atoms and one oxygen atom, frequently combined with carbon and/or hydrogen, as well as an elastomer. The central section 104 comprising a silicone rubber layer may therefore effectively seal against the skin of a patient even after an injection needle has penetrated the central section 104 and subsequently been withdrawn there from. It may also ensure that loose particles, such as woven fabric or metal flakes enter the injection site, if an injection needle penetrates the central section 104 for injecting a patient.

The two lateral sections 102 are skin adhesive on their proximal sides.

Alternatively, for instance if the protective covering is round or squared, the at least two lateral sections 102 could be comprised in a circumferential lateral section.

This means that also the lateral sections 102 may comprise a layer of silicone rubber, as for the central section 104. One of them does not exclude the other.

The lateral sections 102 may be made from a resilient material, such as woven fabric, plastic (PVC, polyethylene or polyurethane), or latex. The adhesive on the proximal side of the protective covering 100 is configured to releasably adhere in a sealed relation to a patient's skin. In one embodiment, a protective covering 100 for human skin application comprises at least two lateral sections 102 and a central section 104. The at least the two lateral sections 102 are skin adhesive on their proximal sides, wherein the central section 104 comprises a silicone layer 104 and is adhesive to plastic or metal on its distal side.

The distal side of the central section 104 is protected by a cover flap 106. In closed configuration, the cover flap 106 is reversibly attached to the adhesive on the silicone layer 104. In open configuration, the cover flap 106 reveals the central section 104 making it accessible to the user. The central section 104 is in this way both kept clean and protected in closed configuration, and non-sticky on the proximal side when the cover flap 106 is closed. The cover flap 106 may comprise a pull tab 114 at its outer end. The pull-tab 114, which will cover part of a lateral section 102 when the cover flap 106 is in closed position, will thus not adhere to the central section 104 or protective covering 100. In this way, the pull tab 114 is used to provide an accessible grip and facilitate easy release of the cover flap 106 from the central section 104. In one embodiment, the protective covering 100 also comprises a cover flap 106 on a distal side of the protective covering 100. The cover flap 106 reveals the central section 104 in an open position and covers and the central section 104 in a closed position. The cover flap 106 may adhere to the central section 104 in the closed position. The cover flap 106 may comprise a pull tab 114 at its outer end which does not adhere to the protective covering 100 when the cover flap 106 is in closed position. The cover flap 106 may be transparent, for allowing visual inspection of the injections site after injection. In this way skin irritation and swelling may be observed.

The proximal side of the lateral sections 102 is protected by a cover foil 112 (i.e. a backing). The covering foil 112 is releasably adhered to the lateral sections 102 and may consist of one or multiple pieces. The covering foil 112 may also protect the central section 104. In figure 1 , a covering foil comprising two pieces with an overlap, protecting both the lateral sections 102 and central section 104. This facilitates easy release of the cover foil 112 by providing a "pull-tab" not adhered to the central section 104 at the overlapping section for easy peel back. In one embodiment the protective covering 100 comprises a cover foil 112 on the proximal side of the lateral sections 102. The covering foil 112 may consist of one or multiple pieces, preferably two pieces with a central overlap.

The silicone layer 104 is suitable for being pierced by a syringe needle 300. The silicone material will not release any small pieces upon piercing. This is desirable, since any release of small pieces might enter the blood stream of the patient.

Furthermore, the subsequent hole in the silicone layer 104 will self-seal upon retraction of the syringe needle 300. In one embodiment, the central section 104 of the protective covering 100 is suitable for being pierced by a syringe needle 300 and will self-seal upon retraction of the syringe needle 300.

As an alternative to the silicone rubber layer 104 or combined with the silicone rubber layer 104, a hydrocolloid layer may be used. The hydrocolloid layer may be in the form of a hydrocolloid wound dressing. A hydrocolloid dressing is a wafer type of dressing that contains gel-forming agents in an adhesive compound laminated onto a flexible, water-resistant outer layer. The wafers are self-adhering and the active surface of the dressing is coated with a cross-linked adhesive mass containing a dispersion of gelatin, pectin and carboxy-methylcellulose together with other polymers and adhesives. The polymers absorb water from the injection site and swell, forming a gel which is held within the structure of the adhesive matrix. The moist conditions produced under the dressing are intended to promote healing of the injection site. In addition to this, the hydrocolloid layer forms a good seal in both directions, just as the silicone rubber.

The proximal side of the central section 104 may also be configured to releasably adhere in a sealed relation to a patient's skin. This is of importance for avoiding any contamination of a clinician with a patient's blood. For certain injections, the skin and the fat tissue are pinched together at the injection site, often using thumb and forefinger. Examples of such injections are certain subcutaneous injections. In such cases, it is extra beneficial if the central section sticks to the skin, such that the above described benefits are still maintained. Furthermore, by sticking tightly to the skin, the protective covering 100 will not impede such an injection procedure. In one embodiment the proximal side of the central section 104 of the protective covering 100 is covered by an adhesive layer.

Another advantage of the silicone material is that the silicone layer 104 may be transparent, allowing the clinician, to see the skin of the patient through the silicone layer 100. Thus, the silicone layer 104 may act as a window through the protective covering 100. This is helpful during the injection, since the clinician may see the direct interaction between the needle 300 and skin of the patient. It also provides the opportunity to follow the progress of healing, and alert the clinician or patient symptoms such as bluch and swelling on the skin. The two lateral sections 102 of the protective covering 100 may also be transparent, for instance if the lateral sections 102 are made from an adhesive plastic film. A protective covering with transparent silicone layer 104 and lateral sections 102 offers great see-through characteristics and provides the physician with excellent visibility of the patient's skin through the applied protective covering 100. In one embodiment, the silicone layer 104 is transparent. The two lateral sections 102 may also be transparent.

Figure 3(3) illustrates a syringe 200 that has a barrel 204, plunger 208, a needle 300, and a needle shield 400. The plunger 208 is inserted into the distal end of the barrel 204 and is slidably movable within the barrel 204 while maintaining a tight fit against the barrel's 204 walls. The syringe 200 may be made of glass or plastic although plastic is preferred given the single use and disposable nature of the syringe 200. The syringe 200 may be pre-filled, containing a solution to be injected 212. The solution to be injected 212 is contained within the barrel 204 in between the plunger 108 and the proximal end of the barrel 204. The solution to be injected 212 could also be inserted as a separate cartridge (not shown) containing the solution to be injected 212. Any suitable solution for injection 212 may be used in the syringe 200. For example, the solution to be injected 212 may contain a drug or a vaccine.

The needle 300 is connected to the proximal end of the barrel 204. A needle cap 302 may be placed over the needle 300. The needle shielding system is made up of a needle shield 400 and a needle bulge 308 located on the shaft of the needle 300 away from the needle tip 304. Needle shield 400 has a base plate 404 and a plate shaft 412 with a hole 408 extending through the shaft 412 for receiving the needle 300 through the centre of the plate 404. Two resilient arms 416 extend away from the base plate 404 in the same general direction as the longitudinal axis of the needle 300. Each arm 416 ends in a hooked tip 420. Figures 3(2) to 3(4) show the arms 416 urged apart from each other into a tension state in which free passage of the needle 300 is possible through the hole 408, while the arms 416 are in contact with the surface of the needle 300. Figures 3(5) to 3(7) show the resilient arms 416 in a resting state in which the needle tip 304 is enclosed within the needle shield 400. Prior to use of the syringe 200, such as during manufacture of the syringe 200, the needle shield 400 is slidably mounted on the needle 300 so that the needle shield 400 is in the tension state referred to above. The two resilient arms 416 extend away from the base plate with different lengths, such that one arm 416 extend further away from the base plate 404 than the other. The arm 416 extending further away from the other arm 416 may be provided with a larger hooked tip portion 420 than the other, to increase interaction area with the protective covering 100. It has been noted that an effective area of the hooked tip portion of the arm 416 extending further away from the other may be larger or equal to

2 mm 2 , such as preferably from 2 mm 2 to 10 mm 2 , such as from 2 to 7 mm 2. The shorter arm 416 may be provided with a hooked tip portion 420 or not. The hooked tip portion 420 of the shorter arm 416 is not intended to interact with the protective covering 100, and could thus be omitted for this purpose only. However, the hooked tip portion of the shorter arm 416 may be provided to improve needle covering and securing in the needle shield 400.

In one embodiment, an injection system 1000 comprises a protective covering 100 and a syringe 200, where the syringe 200 comprises a barrel 204, a plunger 208, a needle 300 and a needle shield 400. The needle 300 comprises a needle bulge 308, a needle shaft, and a needle tip 304, wherein the needle bulge 308 is located on the shaft of the needle 300 away from the needle tip 304. The needle shield 400 is located on the needle shaft between the syringe 200 and the needle bulge 308.

In one embodiment, an injection system 1000 comprises a needle shield 400 with a base plate 404, a plate shaft 412, a hole 408, two resilient arms 416 and hooked tips 420. The hole 408 extends through the shaft 412 for receiving the needle 300 through the centre of the plate 404. The diameter of the hole 408 is smaller than the outer diameter of the needle bulge 308. The two resilient arms 416 are extending away from the base plate 404, in the same general direction as the longitudinal axis of the needle 300. Each of the arms 416 end in a hooked tip 420. The arms 416 are urged apart from each other into a tension state by the needle shaft when the needle shield 400 is an open configuration and the needle tip 304 is outside of the needle shield 400. The arms 416 are in a resting state when the needle shield 400 is in a closed

configuration, in which the needle tip 304 is enclosed within the needle shield 400.

Upon use of an injection system 1000 comprising a syringe 200, with a needle 300 and needle shield 400, and protective covering 100, the skin in the area suitable for injection on the patient is cleaned and disinfected. The protective covering 100, possibly removed from a sterile package 600, has its covering foil 112 removed to expose the proximal adhesive surface of the protective covering 100. The protective covering 100 is then adhered to the disinfected patch of skin on the patient. The cover flap 104 is moved to open position, exposing the central section 104 and silicone layer 104 to the clinician. The syringe needle 300 may now be inserted through the silicone layer 104 to initiate the injection. When the needle 300 is being inserted, the needle shield 400 will come into contact with the distal adhesive surface of the silicone layer 104 of the protective covering 100, as seen in figure 4(3). The proximal end of the needle shield 400 will reversibly adhere to the distal adhesive surface of the silicone layer 104. As will be further described below, this means that as soon as the needle shield 400 has touched the silicone layer 104, the needle safety system has been activated protecting the clinician and associated personnel from accidental contact with the needle tip 304. When the needle 300 has been correctly inserted, the clinician depresses the plunger 208 to inject the solution to be injected 212. Alternatively, the clinician draws blood from the patient. The needle 300 is then withdrawn from the patient, while the needle shield 400 remains adhered to the protective covering 100, which in turn will activate the shielding effect as can be seen in figure 4(4). As the syringe 200 is moved further distally, the needle shield 400 will slide along the needle shaft towards the tip 304 of the needle 300. As the tip exits the skin of the patient and the silicone layer 104 of the protective covering 100, the hole in the silicone layer 104 will self-seal upon retraction of the needle 300, leaving any excess blood trapped beneath the silicone layer 300 on the proximal side of the protective covering 100. When the needle tip 304 passes the hooked tips 420 of the needle shield 400, the arms 416 will snap centrally in front of the needle tip 304. The plate shaft 412 then contacts the needle bulge 308 as shown in figure 4(4) and 4(5). The needle shield 400 can then move no further along the needle shaft and the clinician, patient, and associated personnel are protected from accidental contact with the needle tip 304. As the syringe 200 is pulled further distally, figure 4(5), the needle shield 400 will be pulled until the pulling force exceeds the adhesive force between the needle shield 400 and the silicone layer 104 of the protective covering 100, at which point the needle shield 400 will be released from the protective covering 100, as seen in figure 4(6). The syringe can now be safely disposed of. The proximal cover flap 106 can is now returned its closed position, protecting the silicone layer 104 and making the distal surface of the protective cover 100 non- sticky. The protective covering 100 is left in place until any bleeding has stopped, to protect the injection site from infection and the clinician from contamination. Once the bleeding has stopped, or when the injection wound has started to heal up, the patient or clinician may safely remove the protective covering 100 from the patient. The disposed of syringe 200 and syringe needle 300 with protective clip 400 will be only marginally larger that that of an unprotected syringe, meaning that the use of such a fully protected injection system 1000 will not put extra strain on the handling of sharp /biocontaminated material.

In one embodiment, a method for use of a protective covering 100 comprises the steps of disinfecting an area suitable for injection on the patients skin, attaching the protective covering 100 to said disinfected area, opening the protective covering 100 cover flap 106, injecting or drawing blood from the patient using a syringe 200 and needle 300 through the central section 104 of the protective covering 100, and returning the cover flap 106 to its closed position. In one embodiment, a method for use of a protective covering 100 comprises the steps of disinfecting an area suitable for injection on the patients skin, attaching the protective covering 100 to said disinfected area, opening the protective covering 100 cover flap 106. The silicone layer 104 can now be pierced with the needle 300 until the needle shield 400 attaches to the adhesive surface of the central section 104. The solution to be injected 112 may now be injected, or a blood sample may be drawn from the patient. The needle is then withdrawing from the protective covering 100, while the needle shield 400 remains adhered to the central section 104, whereby the needle tip 304 will pass the hooked tips 420 of the needle shield 400 and the arms 416 snaps centrally in front of the needle tip 304. The plate shaft 412 will contact the needle bulge 308 and pull the needle shield 400 until the pulling force exceeds the adhesive force between the needle shield 400 and the central section 104 of the protective covering 100, upon which the needle shield 400 will be released from the protective covering 100. The cover flap 106 is then returned to its closed position.

The needle shield 400 may be made of a plastic material having a suitable combination of tenacity, rigidity, fatigue resistance, elasticity, and creep deformation resistance. A suitable plastic material has a high creep deformation resistance, i.e. it has a low tendency to slowly move or deform permanently under the influence of an applied external pressure. Hence, needle shield 400 may be stored in an assembled ready mode (tension state) for a prolonged time without extensive creep deformation of the arms 416. A plastic needle shield 400 may be colored for ease of recognition. The needle shield 400 may be a monolithic homogenous injection molded plastic needle shield. An advantage of a monolithic needle shield 400 is a lower production cost in comparison to other devices made of more than one part requiring subsequent assembly. The needle shield 400 may be made of a thermoplastic polymer. The thermoplastic polymer could be crystalline, amorphous, or comprising crystalline and amorphous alternating regions. A creep resistance of the thermoplastic polymer of choice may be at least 1200 MPa (ISO 527, ASTM D638). Suitable plastics for the needle shield 400 may be selected from the group comprising of polyoxymethylene (POM), polybutylen terephthalate (PBTP), polymethyl methacrylate (PMMA), acrylonitrile butadiene styrene (ABS), styrene acrylonitrile (SAN), acrylonitrile styrene acrylate (ASA), polystyrene (PS), styrene butadiene (SB), liquid crystal polymer (LCP), polyamide (PA), polysulfone (PSU), polyetherimide (PEI), polycarbonate (PC), polyphenylene oxide (PPO), and/or PPO/SB, and co- and terpolymers thereof. These polymers have the advantages of providing enhanced storing capacity, even in a strained state, due to the excellent structure memory of these polymers. As can be seen in figure 6, the needle shield 400 may be held in a resting position closer to the needle tip by a resilient mechanism, such as a spring mechanism. Such a mechanism may be a spring 702 or an elastic or collapsible sleeve 704, 706, receiving the needle 300 through the centre of the mechanism. Hence, it is not necessary for the resilient mechanism to apply a counter force, pushing the needle shield towards the needle tip upon compression. It could be enough that the resilient mechanism, in form of the elastic or collapsible sleeve 704, 706, merely holds the needle shield 400 in an upper position, such that it contacts the protective covering close to needle skin penetration, and that the resilient mechanism thereafter is maintained in the compressed state. The collapsible sleeve 704, 706 may be of a telescopic character, with defined friction between telescopic segments, such that one segment moves over another upon pushing the needle shield 400 towards the barrel 204. This is advantageous when a longer needle is used for very shallow injections, such as for subcutaneous injections, still allowing the needle shield 400 to come into contact with the distal adhesive surface of the silicone layer 104 of the protective covering 100. Furthermore, by being resilient, the needle may be inserted even further into the skin after the needle shield 400 has come into contact with the distal adhesive surface of the silicone layer 104. In one embodiment, the injection system 1000 further comprises a resilient mechanism located between the needle shield and the syringe 200. The mechanism may be a spring 702 or an elastic sleeve 704, 706.

The syringe 200 and protective covering 100 may be packaged together in a sterile package 600, as seen in figure 5. The syringe 200 has a needle 300 with a needle guard 400 and optionally a needle cap 302. The syringe 300 may be prefilled, for instance with a vaccine or a drug. The sterile package 600 may also comprise a disinfectant 500, such as a sterilizing napkin, for disinfection of the patient's skin before application of the protective covering 100. One advantage of a kit 1100 containing both syringe 300 and protective covering 100 is that the whole kit 1100 may be sterilized as one, and will remain sterilized until the kit 1100 is opened. In one embodiment, a kit 1100 comprising a syringe 200, with a needle 300, needle guard 400 and needle cap 302, a protective covering 100 are packed in a sterile package 600. A kit 1000 may also comprise a disinfectant 600.

In the claims, the term "comprises/comprising" does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or

advantageous. In addition, singular references do not exclude a plurality. The terms "a", "an", "first", "second" etc do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

1. A protective covering (100) for human skin application, said covering comprising two lateral sections (102) and a central section (104), wherein at least the two lateral sections (102) are skin adhesive on their proximal sides, wherein the central section (104) comprises a sealing layer (104) and is adhesive to plastic or metal on its distal side.

2. The protective covering (100) according to claim 1 , wherein the sealing layer (104) is a silicone rubber layer (104).

3. The protective covering (100) according to claim 1 , wherein the sealing layer (104) is a hydrocolloid layer (104).

4. The protective covering (100) according to claim 1 , wherein the central section (104) comprises a silicone rubber layer and a hydrocolloid layer (104)

5. The protective covering (100) according to any one of the preceding claims, further comprising a cover flap (106) on a distal side of the protective covering (100), which cover flap ( 106) in an open position reveals the central section (104) and in a closed position covers and the central section (104).

6. The protective covering (100) according to claim 5, wherein the cover flap (106) in the closed position adheres to the central section ( 104).

7. The protective covering (100) according to any one of the preceding claims, further comprising a cover foil ( 112) on the proximal side of the lateral sections (102).

8. The protective covering (100) according to any one of the preceding claims, wherein the proximal side of the central section (104) is covered by an adhesive layer.

9. The protective covering (100) according to any one of the preceding claims, wherein the central section (104) is suitable for being pierced by a syringe needle (300) and will self-seal upon retraction of the syringe needle (300).

10. The protective covering (100) according to any one of the preceding claims, wherein said covering foil (112) may consist of one or multiple pieces, preferably two pieces with a central overlap, facilitating easy release by peeling back the cover foil (112) pieces.

11. The protective covering (100) according to any one of claims 5 or 6, wherein the cover flap ( 106) comprises a pull tab ( 114) at its outer end, which does not adhere to the protective covering (100) when the cover flap 106 is in closed position.

12. The protective covering (100) according to any one of the preceding claims, wherein central section (104) is transparent.

13. An injection system (1000) comprising the protective covering (100) according to any one of claims 1 to 12 and a syringe (200), said syringe (200) comprising a barrel (204), a plunger (208), a needle (300), and a needle shield (400), said needle (300) comprising a needle bulge (308), a needle shaft, and a needle tip (304), wherein the needle bulge (308) is located on the shaft of the needle (300) away from the needle tip (304), and said needle shield (400) is located on the needle shaft between the barrel (204) and the needle bulge (308).

14. The injection system (1000) according to claim 13, wherein the needle shield (400) comprises a base plate (404), a plate shaft (412), a hole (408), two resilient arms (416), and hooked tips (420), said hole (408) extending through the shaft (412) for receiving the needle (300) through the centre of the plate (404), said two resilient arms (416) extend away from the base plate (404) in the same general direction as the longitudinal axis of the needle (300), and each of the arms (416) end in a hooked tip (420), the diameter of the hole (408) is smaller than the outer diameter of the needle bulge (308), wherein

the arms (416) are urged apart from each other into a tension state by the needle shaft when the needle shield (400) is an open configuration, and the needle tip (304) is outside of the needle shield (400), and the arms (416) are in a resting state when the needle shield (400) is in a closed configuration in which the needle tip (304) is enclosed within the needle shield (400).

15. A method for use of a protective covering (100) according to any one of claims 1 or 12, comprising the steps of;

i. disinfecting an area suitable for injection on the patients skin,

ii. attaching the protective covering (100) to said disinfected area, and iii. injecting or drawing blood from the patient using a syringe and needle through the central section (104) of the protective covering (100).

16. A method for the use of an injection system (1000) according to any of claims 13 or 14, comprising the steps of;

i. disinfecting an area suitable for injection on the patients skin,

ii. attaching the protective covering (100) to said disinfected area, iii. injecting or drawing blood from the patient using the syringe (200) through the central section (104) of the protective covering ( 100) by piercing the central section (104) of the protective covering (100) with the needle (300) until the needle shield (400) attaches to the adhesive surface of the central section (104),

iv. injecting the solution to be injected (212), or taking a blood sample from the patient,

v. withdrawing the needle (300) from the protective covering (100) while the needle shield (400) remains adhered to the central section (104), and

whereby the needle tip (304) will pass the hooked tips (420) of the needle shield (400) and the arms (416) snaps centrally in front of the needle tip (304) and the plate shaft (412) will contact the needle bulge (308) pulling the needle shield (400) until the pulling force exceeds the adhesive force between the needle shield (400) and the central section (104) of the protective covering (100) and the needle shield (400) will be released from the protective covering (100),.

17. A kit (1100) comprising the protective covering (100) according to any of claims 1 to 12, and a syringe (200) comprising a needle (300) and a needle shield (400).

18. A kit (1100) according to claim 17, further comprising a disinfectant (500).