NEEDLE SHIELD

BACKGROUND OF THE INVENTION

[0001] The invention relates to a needle shield.

[0002] The invention further relates to an instrument receptacle comprising a protective bag made from a sterilizable material and provided with a first enclosed space formed inside the bag.

[0003] The purpose of a needle shield is to protect the user of the needle, for example a person taking a sample, or other persons, from accidental needle punctures. Such punctures are painful and, in addition, they may contaminate the sample. A particularly serious damage may occur if as a result of an accidental needle puncture viruses, bacteria or other pathogens carried by the needle get into the organ system. For example, it would be most unfortunate if an AIDS virus or another similar, potentially even lethal virus infection, would get into the organ system through a needle.

[0004] Prior art knows a number of solutions for implementing a needle shield. However, known needle shields have a complex structure and consist of several parts, which is why they may be inconvenient in use and their operational reliability may be deficient. Due to their complicated structure, prior art needle shields are also expensive. Yet another problem associated with prior art needle shields is that in some solutions the most practical way to take or move the needle tip out of the shield requires an operating position in which the risk of the needle tip coming into contact with the user's arm or body is unreasonably high.

BRIEF DESCRIPTION OF THE INVENTION

[0005] It is an object of the invention to provide a new and improved needle shield that offers solutions to the above problems.

[0006] The needle shield of the invention is characterized in that it comprises: a first part, the first part having fastening means arranged thereto for fastening a needle to the first part; a second part, a first end of the second part being provided with a hole allowing the needle fastened to the first part to be inserted therethrough; the first part being movably arranged at least partly inside the second part; the needle shield further comprising: a threaded portion arranged to the first or the second part and a counter portion compatible with it, the counter portion being arranged either to the second or the first part, respectively, the first part being rotatable in relation to the second part from a

safety position, in which the needle tip is protected inside the second part, to a position of use, in which the needle extends through the hole so that the needle tip is exposed from the needle shield.

[0007] The instrument receptacle of the invention is characterized in that the first enclosed space has a needle shield according to claim 1 arranged therein.

[0008] An essential idea of the invention is that the needle shield comprises two parts that are rotatably movable in relation to each other in their respective longitudinal directions, the moving of the parts allowing the needle tip inside the protective needle shield to be exposed from and retracted back into the needle shield.

[0009] One of the invention's advantages is its remarkably simple structure: the needle shield may consist of as few as two parts, and, moreover, they are simple in shape and easy to join together.

[0010] A further advantage is that the needle shield of the invention is extremely safe to use: the rotating needed for exposing the needle tip into the position of use is convenient and easy, the possibility of the needle tip coming into contact with the user's arm or other body part being extremely small.

[0011] An essential idea of an embodiment of the invention is that, arranged in association with the means for fastening the needle, there is provided a conical outer surface, or a part thereof, extending for a distance from the first part and that in connection with the hole there is provided a conical inner surface, of a part thereof, dimensioned so that the conical outer surface or the part thereof may be arranged to it in order to produce a conical locking, when the needle shield is in the position of use.

[0012] An advantage of this is that the conical locking provides a simple means for increasing the fastening strength of the needle in its position of use.

[0013] An essential idea of a second embodiment of the invention is that the needle shield comprises a first locking member configured to lock the needle into its safety position and/or a second locking member configured to lock the needle into its position of use.

[0014] This provides an advantage in that it enables the needle shield to be firmly locked into its safety position and/or its position of use,

whereby the risk of the needle shield moving accidentally from one position to the other is extremely small.

[0015] An essential idea of a third embodiment of the invention is that at the rear part of the first part there are provided fastening means or surfaces allowing infusion means or a sampling tube, for example, to be fastened to the needle shield.

[0016] An advantage of this is that it allows dosing or sampling instruments to be simplified.

[0017] An essential idea of a fourth embodiment of the invention is that the needle shield comprises a third locking member allowing the first and the second part of the needle shield to be locked in such a way that the needle is safely inside the needle shield and can be exposed from there only by using increased force or by breaking the structure of the needle shield.

[0018] An advantage of this is that once the needle has been used for puncture or it is to be considered contaminated or unfit for use for some other reason, the needle can be locked inside the needle shied in such a way that it cannot be accidentally used for puncture.

BRIEF DISCLOSURE OF THE FIGURES

[0019] In the following, some embodiments of the invention will be disclosed in greater detail with reference to the accompanying drawings, in which

Figure 1 is a schematic perspective view of a needle shield of the invention separated into parts;

Figure 2 is a schematic perspective view illustrating a longitudinal section of the needle shield of Figure 1 separated into parts;

Figures 3a, 3b are schematic cross-sectional perspective views of the needle shield of Figure 1;

Figures 4a to 4d are schematic perspective views of a second needle shield of the invention;

Figures 5a to 5c are schematic views of a third needle shield of the invention;

Figures 6a, 6b are side views of the needle shield of Figure 1;

Figures 7a, 7b are cross-sectional views of the needle shield of Figures 6a, 6b, taken along line A-A and seen from the end; and

Figure 8 is a schematic perspective view of an instrument receptacle of the invention.

[0020] For the sake of clarity the invention shown in the Figures has been simplified. Like parts are referred to with like reference numerals.

DETAILED DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

[0021] Figure 1 is a schematic perspective view of a needle shield of the invention separated into parts, Figure 2 is a schematic perspective view illustrating a longitudinal section of the needle shield of Figure 1 separated into parts, and Figures 3a, 3b are schematic cross-sectional perspective views of the needle shield of Figure 1.

[0022] The needle shield comprises a first part 1 and a second part 2, which are preferably made from a polymer material, such as thermoplastic plastic or a plastic mixture. A preferred manufacturing method is injection moulding, although other mould methods may also be used.

[0023] The basic shape of both the first part 1 and the second part 2 is a hollow circular cylinder. The parts 1 , 2 are dimensioned so that a portion of the outer surface 3 of the first part 1 fits into the second part 2, preferably so that the diameter of the portion of the outer surface 3 of the first part 1 is almost equal to the inner diameter of that portion of the inner surface 4 of the second part into which the first part 1 is to be fitted.

[0024] The inner surface 4 of the second part 2 is provided with a threaded portion 7, which in the embodiment referred to consists of a groove spiralling on the inner surface and advancing in the direction of a longitudinal axis X. On the outer surface 3 of the first part 1 there is provided a counter portion 16 to this threaded portion, in the disclosed embodiment the counter portion is implemented as a protrusion or a pin and it is preferably integrated into the outer surface 3 of the first part by manufacturing it in the same process as the first part 1. The counter part 16 is dimensioned so that it fits into the groove formed by the threaded portion 7 and is capable of moving in there in the longitudinal direction of the threaded portion. It should be noted that the needle shield may comprise a plural number of parallel threaded portions each having their respective counter parts moving in them.

[0025] The first part 1 is inserted into the second part 2 by fitting the counter portion 16 into the groove forming the threaded portion 7. When the first part 1 is then rotated in relation to the second part 2 about the longitudinal

axis X of the parts 1, 2, the counter portion 16 moves in the groove provided in the threaded portion 7 and thereby forces the first part to move in the direction of the longitudinal axis X. The direction of movement between the parts 1, 2, i.e. whether the first part 1 moves into or out of the second part 2, depends on the direction of the rotation.

[0026] The pitch of the threaded portion 7 is preferably such that the rotational motion required to make the counter portion 16 move from one end of the threaded portion 7 to the other is not more than about 360°. This means that a full displacement in the direction of the longitudinal axis X can be conveniently achieved without having to change hold of the parts 1, 2. Naturally the pitch of the threaded portion 7 may be even greater, for example such that the required rotational motion is 180°, or even less.

[0027] The first part 1 has fastening means 12 attached thereto for fastening a needle 9. The needle 9 shown in Figure 1 is a cannulated needle for taking a blood sample, for example, or a similar fluid sample from the body. It is also possible that the needle 9 is meant for supplying liquid substances, such as a saline solution or blood plasma into the body. The needle 9 comprises a sharp needle tip 21, which is stuck into the patient typically through the skin. The other end 23 of the needle may be sharp as well, as in the needle of the Figure, but it may also be tipless. The needie 9 and its use are known per se and therefore not discussed in greater detail in this context. However, it is to be further pointed out that the needle shield may be used not only for puncturing humans but also animals.

[0028] The other end 23 of the needle is provided with an elastic valve 10 arranged thereon to prevent blood discharge through the other end 23 before a blood-collecting sampling needle has been attached to the needle 9. This is a prior art feature.

[0029] The fastening means 12 are arranged to an end flange 24 provided at the front portion of the first part. The needle 9 is fastened by means of an interference fit to a hole provided in the end flange 24 and coaxial with the mid-axis X. There are also other ways to fasten the needle, for example by gluing, welding, by means of laser or ultrasound, or by some other means known in the art.

[0030] The second part 2 has a first end 5 provided with a hole 15 through which the needle 9 may move in the longitudinal direction thereof. In the embodiment of the Figure the hole 15 is fairly long and mostly arranged

inside a tip 8. The hole 15 has a conical shape, its diameter decreasing towards the distal end of the tip 8. However, it is obvious that the tip 8 is by no means indispensable but the second part 2 may also be implemented without one. It is also evident that the hole 15 does not necessarily need to be conical, but it may be cylindrical, for example, or implemented as a combination of shapes of different cross-sections, such as conical and cylindrical shapes. Here the hole 15 has a circular cross-section, but another shape, such as a polygon, is also possible.

[0031] When the needle shield is in its position of use, i.e. in the position shown in Figure 3b, the needle 9 attaches to the needle shield not only via the fastening means 12 but also the conical outer surface 17 arranged to the means and pressing against the conical inner surface 18 of the hole 15. The conical outer surface 17 consists of four protrusions which each comprise a conical outer surface. Between the protrusions there are gaps or cuts intersecting each other on the mid-axis X. The conical inner surface 18 bends and presses the protrusions against the needle 9, thereby keeping the needle even more firmly in its place during the puncture.

[0032] There are naturally also other ways to form the conical outer surface 17; for example, the number of its protrusions may be other than four. The conical outer surface 17 may also be formed of an elastic material, such as a suitable rubber material, which presses against the needle 9 wedged by the conical inner surface 18.

[0033] Instead of a uniform rotationally symmetrical conical surface, such as the one shown in the Figures, the conical inner surface 18 may be formed of radial protrusions arranged into the hole 15 at a distance from one another, the inner surface of the protrusions forming sections of the conical surface, or of conically arranged planar surfaces, or some other similar tapering surfaces.

[0034] With the needle shield in the safety position, the tip 21 of the needle is safely inside the second part 2, or, to put it more precisely, the needle tip 21 is in the hole 15 inside the tip 8 of the second part. In the safety position the needle tip 21 cannot cause injury to persons handling the needle shield.

[0035] In Figure 3b the needle shield is in the position of use in which the needle tip 21 is exposed from the needle shield. Its position may be changed from the safety position into the position of use by rotating the first

part 1 in relation to the second part 2 such that the counter portion 16 moves in the groove of the threaded portion 7 from a first end 25 to a second end 26 thereof.

[0036] The rear part of the first part 22 is shaped and dimensioned so that a counter surface 11 for receiving a sample container known per se for receiving a blood sample is formed. The sample container, not shown in the Figures for the sake of clarity, is inserted into the rear part 22 of the first part through an open end thereof in such a way that the second end 23 of the needle pierces the cover of the sample container whereby due to a negative pressure prevailing in the sample container, blood flows through the needle 9 into the sample container.

[0037] A particular advantage of the needle shield of Figures 1 to 3b is its structural simplicity: with as few as only two parts, i.e. the first and the second part 1, 2 it is possible to produce a structure which functions not only as a needle shield but also as a fastening body for the needle 9 and, moreover, as a structure providing a counter surface carrying and guiding the sample container. The simplicity of the structure is a significant aspect, firstly, because a simple structure is operationally reliable and secure also in extremely demanding field conditions and, secondly, because of low manufacturing costs of the needle shield.

[0038] Figures 4a to 4d are schematic perspective views of a second needle shield of the invention. The needle shield shown here differs from the one discussed above in that the first part 1 of the needle shield functions as a needle body 27 to which the needle θ is undetachably secured. The needle body 27 may be injection moulded, for example, onto the needle 9.

[0039] As to the needle body 27 itself, it is provided with fastening means 28 for fastening the needle body to a carrier element 29 into which a sample container will be fastened when samples are taken. In other words, the needle body fastening means 28 fasten the needle shield to the sample container carrier element 29. The sample container, known per se, is not shown in the Figures.

[0040] Figure 4a shows a detachable transport cover 30 arranged on the needle shield to protect it and the needle 9 inside it from any damage during transport and storage. The needle shield is in the safety position under the transport cover 30. The transport cover 30 is preferably removed from the needle shield just before the needle is used on a patient.

[0041] In Figure 4b the transport cover 30 on the needle shield has been removed, but the needle shield is still in the safety position, thereby preventing the needle tip 21 from causing injury to a person taking a sample or to any other persons. The first part 1 of the needle shield comprises a pin-like counter portion 16 for the threaded portion. The second part 2 of the needle shield, which is dimensioned to fit onto the first part 1, comprises the threaded portion 7. The threaded portion 7 forms a long spiralling through-hole extending through the second part 2, i.e. the threaded portion 7 extends from the inner surface of the second part 2 to the outer surface. Unlike in Figures 1 to 3, there is no tip in the second part 2, but one could naturally be provided to the needle shield of Figures 4a to 4d. Here the hole 15, through which the needle tip 21 moves from the safety position into the position of use and vice versa, is an opening provided at one end of the second part 2. The counter portion 16 is arranged into the threaded portion 7. Consequently, the second part 2 can be rotated in relation to the first part 1 , the threaded portion 7 and the counter portion 16 thus forcing the second part 2 to move in the longitudinal direction of the needle 9.

[0042] In Figure 4c the needle shield in its position of use, i.e. the second part 2 has been rotated so that it does not cover the needle tip 21. This needle shield position allows the needle 9 to be inserted into the patient.

[0043] When the needle 9 has been removed from the patient, the second part 2 of the needle shield is returned to the positron shown in Figure 4d, i.e. to the safety position. Now the needle tip 21 is again safely inside the needle shield and cannot accidentally harm people. The needle shield, the needle 9 and the sample container carrier element 30 may thus be taken away in order to be appropriately disposed of, the needle reducing the risk of unintentional punctures also in connection with the disposal.

[0044] Figures 5a to 5c schematically illustrate a third needle shield of the invention.

[0045] The needle shield comprises a first part 1 , which also forms the needle body 27. On the outer surface of the first part 1 there is arranged a threaded portion 7 that forms a protrusion in the shape of a screw thread ridge advancing in the longitudinal direction of the needle 9. The threaded portion 7 is preferably of the same material as the other parts of the first part 1 and manufactured in the same process with it, for example by injection moulding thermoplastic plastic.

[0046] The needle shield further comprises a hollow second part 2 into which the needle tip 21 may be arranged. The second part 2 is also preferably made by injection moulding. The inner surface 4 of the second part comprises a spiral groove forming the counter portion 16 to the threaded portion. The threaded portion 7 is arranged into the spiral groove and then the second part 2 may be moved in relation to the first part 1 in the longitudinal direction of the needle 9 by rotating the threaded part 7 in the spiral groove.

[0047] The first part has a first portion of a third locking member 31 arrange therein, the first portion being a recess 32 with steep sides and arranged close to the end of the first part 1 at the needle tip 21. Correspondingly, the second part 2 has a second portion of the third locking member arranged therein, the member being a protrusion 33 that fits into the recess 32 and is attached to the second part with a suitably flexible support.

[0048] In Figure 5b the needle shield is shown in its position of use. In this position the protrusion 33 of the third locking member serves as a part of the second locking member, the second locking member locking the needle shield into the position of use. To achieve this the flexible support presses the protrusion 33 against the first part 1 , the friction created between the protrusion and the first part 1 providing a sufficient force to keep the parts locked to each other. The first locking members, i.e. those locking the needle shield into the safety position, may also be implemented in the same way. In that case the protrusion 33 presses against the surface of the first part located closer to the needle tip 21.

[0049] In Figure 5c the needle shield is shown in a second safety position into which it is set when the needle has already been used for puncture or it has become unfit for use for some other reason. The second part 2 is rotated onto the first part 1 for such a distance that the protrusion 33 of the third locking member goes into the recess 32 forced by the support. This means that the needle shield can no longer be opened into the position of use, because the protrusion 33 in the recess 32 prevents the rotating motion between the first and the second part. Since the exposure of the needle tip 21 from the needle shield would require an extremely great force, or even breaking the needle shield structure, the needle cannot be unintentionally taken out of the needle shield.

[0050] Figures 6a and 6b are side views of the needle shield of Figure 1, and Figures 7a and 7b show a cross-section of the needle shield of Figures 6a and 6b, taken along lines A-A and B-B shown in Figures 6a and 6b.

[0051] In Figures 6a and 7a the needle shield is in the position of use, i.e. the tip 21 of the needle 9 is exposed from the needle shield and ready for use. As shown in Figure 7a, in this situation the counter portion 16 is in the second locking member 20 arranged at the other end 26 of the threaded portion 7. The second locking member 20 locks the needle shield into the position of use. The second locking member 20 comprises a second retainer, i.e. a protrusion 43, which prevents the counter portion 16 from accidentally moving away from the second end 26. When the user of the needle shield wishes to rotate the needle shield into the safety position, the first and/or the second part 1, 2 yield so as to let the counter portion 16 past the second retainer 43, thus allowing the needle shield to be rotated into the safety position.

[0052] In Figures 6b and 7b the needle shield is shown in the safety position, i.e. the needle tip 21 is inside the needle shield. At the first end 25 of the threaded portion 7 there is a first locking member 19, which comprises a first retainer, i.e. a protrusion 42. The first locking member 19 operates in the same way as the second locking member 20 disclosed above. When the needle shield is delivered to the user, the counter part 16 is within the first locking member 19. The needle shield can be brought to the position of use by rotating the counter portion 16 over the first retainer 42, all the way to the second locking member 20 at the other end 26 of the threaded portion, and over the second retainer 43 provided there.

[0053] In Figures 6b and 7b the needle shield is in the second safety position, i.e. the parts 1, 2 are in the position into which they are rotated after the needle has been used. The counter portion 16 has been rotated over the first locking member 19 into a third locking member 31, which comprises a third retainer 44 and a recess 32 behind the retainer. The counter portion 16 cannot be rotated away from the recess 32 accidentally but only by applying an extremely great force. Therefore there is no risk of the needle being unintentionally rotated out of the needle shield.

[0054] The first and the second locking members 19, 20 and the third locking member 31 can naturally all be implemented in other ways, too. It

is also possible that the needle shield does not comprise all the disclosed locking members 19, 20 and 31.

[0055] Figure 8 is a schematic perspective view of an instrument receptacle of the invention.

[0056] The instrument receptacle comprises a protective bag 34 made from a flexible, preferably at least partly transparent and sterilizable thermoplastic plastic material. Inside the protective bag 34 there is provided a first enclosed space 35 into which is arranged a needle shield according to the above description in its safety position, and a needle fastened to the shield.

[0057] The instrument receptacle further comprises a second enclosed space 36 and a third enclosed space 37. The enclosed spaces 35, 36, 37 are isolated not only from the environment of the protective bag 34 but also from each other into separate enclosed spaces. The adjacent spaces are separated from one another with heat-sealed seams 38.

[0058] The second enclosed space 36 contains a disinfecting wipe 39 for disinfecting the area on the patient's skin that is to be pierced. Instead of the disinfecting wipe the enclosed space 36 may be provided with any other suitable disinfecting means, such as a disinfecting pad or spray, or any other disinfecting means known per se in the art.

[0059] The third enclosed space 37 contains a bandage pad 40 and a tape 41 attached thereto for fastening the bandage pad onto the needle mark. Instead of the bandage pad 40 and the tape 41 the third enclosed space 37 may naturally be provided with some other known means, such as a plaster or the like, for closing a needle wound.

[0060] Further, the instrument receptacle can naturally be provided with a fourth enclosed space to accommodate a sample container, for example. Another possibility is to place the sample container into the first enclosed space 35 together with the needle shield.

[0061] Apart from the sample container, the instrument receptacle contains all instruments needed for taking a blood sample. The receptacle significantly facilitates sampling especially in situations in which appropriate laboratory, hospital, or similar sampling premises are not available. Such situations often emerge for example in different projects in developing countries or in disaster areas.

[0062] In addition to the needle shield and the needle the instrument receptacle may naturally also contain other instruments apart from

those mentioned above. For example, for the purpose of infusion, the instrument receptacle may further comprise a disinfecting means, an infusion module to be attached to the needle shield and a means for closing the wound.

[0063] The protective bag 34 and its contents can be sterilized by means of ethylene oxide or by gamma radiation, for example, or by some other sterilizing method known per se.

[0064] Further, the instrument receptacle may be manufactured of a substantially rigid material or material which is partly rigid and partly flexible.

[0065] In some cases the features disclosed in this application may be applied as such, irrespective of the other characteristics. On the other hand, the features disclosed here may, if necessary, be combined to provide different combinations.

[0066] The drawings and the associated specification are only meant to illustrate the idea of the invention. The details of the invention may vary within the scope of the claims.