FINGER NEEDLE PUNCTURE BLOOD COLLECTOR

Abstract

The current invention concerns an integrated medical device for a self-collection test, which allows for both puncturing and collecting a blood sample.

Claims

1-13. (canceled)

14. A device for collecting a blood sample, the device comprising: a holder for receiving a sample object, wherein the holder defines an opening for attaching a container, the container making a direct connection between the holder and a casing, the container comprising a first opening and a closing mechanism for closing the first opening of the container; wherein: the casing comprises an opening, a perforation system, and a spring; the perforation system is movable by the spring in the opening of the casing and in the container between a first position and a second position, the perforation system is located at least partially outside the container in the second position; the container further comprises a safety system that, after attachment of the container to the holder, prevents an activation of the perforation system and that, after removing the safety system, facilitates the activation the perforation system.

15. The device according to claim 14, wherein the perforation system comprises a number of perforation elements.

16. The device according to claim 15, wherein the perforation system comprises at least three perforation elements.

17. The device according to claim 16, wherein the holder comprises a second opening for receiving the sample object.

18. The device according to claim 14, wherein the holder comprises a designation that allows for correctly positioning the holder in respect of the sample object.

19. The device according to claim 14, wherein the holder comprises a recess that allows for visually checking the blood sample volume.

20. The device according to claim 14, wherein the holder comprises an indicator for the indication of the required blood sample volume.

21. The device according to claim 14, wherein the holder allows for storage of the blood sample.

22. The device according to claim 14, wherein the perforation system further comprises a sealing ring for closing the second opening of the container.

23. The device according to claim 14, wherein the casing further comprises a spring holder for the attachment of the spring and for the attachment of the perforation system in the housing.

24. A kit comprising the device according to claim 14 and a ring for a temperature indication of the sample object.

25. The kit according to claim 24, further comprising a blood sample anticoagulant located inside the container.

Description

SHORT DESCRIPTION OF THE FIGURES

[0021] Under specific reference to the figures, it is emphasized that the shown details only serve as manner of example and are only for the illustrative discussion of the different embodiments of this invention. They are proposed with the objective of the delivering of what can be seen as the most useful and immediate description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show more structural details of the invention as necessary for a fundamental understanding of the invention. The description in combination with the figures makes it clear for the experts in the field how the different forms of the invention can be implemented in practice.

[0022] FIG. 1A: Is a cross section of a medical device, according to an embodiment of the current invention.

[0023] FIG. 1B Is a medical device, according to an embodiment of the current invention.

[0024] FIG. 2: Is a detail recording of a medical device, according to an embodiment of the current invention.

[0025] FIG. 3: Is a cross section of a medical device, according to an embodiment of the current invention.

[0026] FIG. 4: Is a schematic rendition of a part of the kit of a medical device, according to an embodiment form of the current invention.

[0027] FIG. 5: Is a schematic rendition of a medical device, according to an embodiment of the current invention.

[0028] FIG. 6: Is a medical device, according to an embodiment of the current invention.

DETAILLED DESCRIPTION OF THE INVENTION

[0029] We refer to FIG. 1A and 1B, FIG. 1A shows a cross section of a medical device according to an embodiment of the current invention and FIG. 1B shows a medical device, according to an embodiment of the current invention. The collection phase starts with the placement of the attachment ring 3 (hereinafter also referred to as “holder”). The user preferably puts this on the ring finger of the non-dominant hand.

[0030] In addition, the holder 3 has a height difference 34. This prevents the remaining blood, after collection, from being smeared over the finger. A cut-out 33 (hereinafter also referred to as “recess”) is provided to facilitate quick monitoring of the quantity of blood.

[0031] In addition, a casing 2 and the container 4 (hereinafter also referred to as “collector”) can be used. An anticoagulant can also be used in the container 4 so that the collected blood sample does not clot. The user of the medical device 1 must first remove the cap 44 (hereinafter also referred to as “closing mechanism”) from the first opening 41 of the container 4 by means of a rotary motion. This causes a volume indicator 42 to appear (hereinafter also referred to as “indicator”). This is followed by turning the first opening 41 of the container 4 into the first opening 31 of the holder 3.

[0032] We refer to FIG. 2 that shows a detail recording of a medical device, according to an embodiment of the current invention. When fastening the container 4, there is the possibility of accidently discharging the lancets 210 (hereinafter also referred to as perforation elements). The security system 45 prevents that. By a simple pulling movement, the security system 45 can be removed from the outside of the container 4.

[0033] We refer to FIG. 3 that shows a series of cross sections of a medical device, according to an embodiment of the current invention. By pushing the casing 2 forward, the container 4 touches the spring holder 25, which subsequently opens and releases the perforation system (hereinafter also referred to as the “lancet holder”). The perforation system 21 moves forward quickly and punctures the finger when the kinetic energy is at its maximum. This is also the neutral position of the spring 22. The remaining energy, which is normally used for oscillation, is now fully used for puncturing. All of this ensures a quicker and accordingly less painful puncture.

[0034] The puncture is followed by the retraction. By stopping to push on the casing 2, it bounces back spontaneously through the legs of the spring holder 25. Finally, the user must briefly pull the casing 2 backward. This way, the system falls into a lock by means of the hooks 6 provided. To get a smoother communication of “how far” the pull must be, a lock will appear that shows the correct “locked” phase. This lock forms a fixed collection volume. A maximum volume of 750 μl can be collected. This gives sufficient volume for when something goes wrong.

[0035] After a successful collection, the casing 2 and the container are removed by a simple rotary movement. The closing mechanism 44 is subsequently tightened again and the holder 3 is removed.

[0036] We refer to FIG. 4 showing a schematic rendition of a part of the kit of a medical device, according to an embodiment form of the current invention. The thermochromic ring 5 is a part of the kit of the current medical device, according to an embodiment form of the current invention, with which the user comes into contact. The ring is preferably put on the middle finger of the non-dominant hand. The user then lets warm water run. The user uses the ring as indicator for the heat of the water. This has a thermochromic zone 50 that changes colour between 42.5° C. and 45° C. Effective simulation can take place from when discolouration occurs. The user washes the hands for two minutes. The hands are then dried, and collection can begin.

[0037] Technically, the ring can be manufactured via co-injection of two silicones. One of the silicones 51 comprises the reference colour while the other silicone 50 has a thermochromic master batch. The ring approaches the form of the ring finger.

[0038] We refer to FIG. 5 that shows a schematic rendition of a medical device, according to an embodiment of the current invention.

[0039] By using a nail and right-left-designation 32 (hereinafter also referred to as “designation”), near the holder 3, people are still capable of finding the correct needle puncture site near the nail bed. Finally, the container 4 makes an angle of approximately 60 degrees 46 with the casing 2, which can be attached with the help of a double screw thread 47. Technically, the holder 3 can be manufactured by, via co-injection, a soft silicone and a hard-transparent polypropylene (hereinafter also referred to as “PP). The hard plastic ensures a smooth needle puncture collector attachment and a clear nail designation.

[0040] Components of the Invention

[0041] Below, we provide a summary of a number of useful materials with regard to different components of the invention. These materials are for illustration only and not limited to the current invention.

[0042] The first component or cap 44 can be an elementary screw-on cap with double screw thread. The unit can, for example, be die cast in PP. The cap 4 can be provided with ridges to accentuate the rotary motion.

[0043] The next component is the casing. The unit can be die cast in PP. The rear of component can be provided with ridges for additional grip.

[0044] The third component is preferably a transparent polycarbonate (hereinafter also referred to as PC) collector 4. The unit can be a die cast co-injection between the volume designation and the collector. The unit can be provided with a double screw thread. The correct amount of liquid EDTA can be added after assembly.

[0045] The fourth component or the safety system 45 can also be a die cast PC. The ridges and dart can ensure smooth removal.

[0046] The fifth component or the lancets 210 can be manufactured from stainless steel. As an example, we use a triple order lancet with a length of 2.4 mm and 0.64 mm diameter. This is analogous to the medical test. The lancet itself will preferably protrude approximately 3 mm from the lancet container 21.

[0047] Component six of the lancet holder 21 can be die cast in BP. We can attach the lancets with the help on the insert moulding. The unit can be made with a slope for a smooth installation of the seal. A hook can also be provided at the back for the attachment of the spring.

[0048] The spring 22 can be manufactured from spring steel. The spring has, for example 13 coils, a free length of 23 mm, a wire thickness of 0.5 mm and an outer diameter of 6 mm. These may still vary, depending on the actual application.

[0049] Finally, we have the spring holder 25. This component can also be die cast PP. Space can also be provided to attach the spring as well as two snap connectors. These connect the spring holder to the connector.

[0050] We refer to FIG. 6 that shows a medical device according to an embodiment of the current invention.

[0051] The holder 3 can be attached to the ring finger of the right hand. The container 4 can be tightened to the holder. The casing can be held with the help of the left hand to activate the medical device accordingly.