WO2015020609A1

WO2015020609A1 - A blood extraction system for extracting and collecting capillary whole blood

Info

Publication number: WO2015020609A1
Application number: PCT/SG2013/000338
Authority: WO
Inventors: Chee Yen Lim; Wei Siong Lee; Yong Wei CHIA
Original assignee: Chee Yen Lim
Priority date: 2013-08-07
Filing date: 2013-08-07
Publication date: 2015-02-12

Abstract

The present invention relates generally to finger-pricking devices for extracting capillary whole blood for in-vitro diagnostic testing. More particularly, the present invention relates to devices that prick fingers, collect and dispense capillary whole blood on a test media for the purpose of carrying out in-vitro diagnostic (IVD) testing. In the preferred embodiment, the blood collection means is a measurement and collection tube. The incorporated blood measurement and collection tube enables a user single-handedly to prick his finger with safety lancet, milk the lanced site to obtain a desirable size of blood droplet, and collect and measure at the same time the desired volume of blood with the present invention. The user may estimate the blood volume collected in the tube by seeing the blood column's movement relative to the graduation scale on the device, and he may stop the collection process by separating the tube from the blood. Alternatively, the capillary tube may be made to have a predetermined capacity to only collect the predetermined amount of blood sample for a particular IVD test. This is particularly crucial for advanced point-of-care testing systems which provide quantitative and high accuracy results. Result accuracy often requires that the blood sample by filling up the predetermined capacity. Lastly, the user may dispense the collected blood onto a test media by making physical contact between the tube's opening and the test media.

Description

TITLE: A BLOOD EXTRACTION SYSTEM FOR EXTRACTING AND

COLLECTING CAPILLARY WHOLE BLOOD

FIELD OF THE INVENTION

The present invention relates generally to finger-pricking devices for extracting capillary whole blood for in-vitro diagnostic testing. More particularly, the present invention relates to devices that prick fingers, collect and dispense capillary whole blood on a test media for the purpose of carrying out in-vitro diagnostic (IVD) testing.

BACKGROUND OF THE INVENTION

Safety lancets have been widely used in hospitals where finger pricking is carried out on a large scale by the medical practitioners. These safety lancets consist of needle and an actuation system that are housed in a casing. This design provides safety to the medical practitioners by avoiding the handling of the needles and concealing the needles at all times. The blood extracted by the finger-pricking procedure will normally be collected with a capillary tube or a disposable pipette after which the blood will be dropped or spotted on the test media. The blood should not be placed direcdy from the pricked finger to the test media because the skin has been breached and there is great possibility that the chemicals or reagents on the test media may enter the body. Some molecular diagnostic testing requires that blood be dried and spotted on a piece of filter paper, after which a fraction of the blood spotted paper is punched and placed inside specific reagents to retrieve DNAs (deoxyribonucleic acids) for amplification through PCR (polymerase chain reaction) and then further analysis. This blood attainment procedure involves multiple steps and devices which may pose inconvenience and blood contamination hazard during the course of juggling in between the devices. This complicated procedure is not conducive for home users who need to carry out IVD tests by themselves. The advancement of point-of-care testing requires that the blood volume for each test to be precise so that the diagnostic results can be accurate. Current practice of collecting the blood samples using a disposable pipette or a capillary tube does not ensure that the blood samples collected are precisely required by the point-of-care testing. US patent 8,333,781 B2 awarded to Becton, Dickinson and Company shows some safety lancets that consist of a casing, a spring for storing and releasing energy, a needle component, and a release mechanism to release said needle from compression of the spring. These are the typical safety lancet components required to conceal a spring-operated needle in a disposable casing. All such safety lancets on the market and in the literature do not comprise a blood collection and measurement means such that the finger pricking action can be seamlessly followed by blood collection and measurement without needing to juggle between several devices.

US patent 5,518,006 awarded to International Technidyne Corp. attempted to solve this problem by combining an auto-pricking lancet with a reservoir to collect the blood. As reported in the patent, the reservoir has a narrowing outlet end to contain the blood until the oudet end is in contact with some test media, after which the blood in the reservoir will be transferred to the test media for diagnostic testing. There are some shortcomings arisen from the prior art. For example, after pricking his finger with the auto-pricking lancet, the user has to drop the blood on his finger into the reservoir, which is located at the opposite end of the lancet's pricking end. Secondly, the reservoir has to be carefully filled Up to avoid forming air bubbles so that the blood can reach the end of the oudet at the bottom prior to the blood transfer to the test media when it is made in contact with the bottom oudet. Thirdly, there is also no scale to indicate the volume of the blood which is collected in the reservoir, which means that the reservoir is design for a specific test media only, the prior art device is not meant for other devices.

US patent 5,951,492 awarded to Mercury Diagnostics, Inc. reports a prior art device that include a disposable lancet integrated with a capillary tube which is downwardly slideable within the casing to reach the blood droplet. The capillary tube is friction fitted into the disposable lancet, which allows sliding movement. To achieve the blood sampling procedure without taking the prior art device off the skin, the device has to be equipped with a drop detection system so that the user knows when to slide the capillary tube downward within the casing to collect the blood. The capillary tube is connected to a test strip and only acts as a conduit to transfer the blood droplet from the skin to the test strip.

US patent 7,901,363 B2 awarded to Roche Diagnostics Operations, Inc. teaches a similar prior art that extract and collect blood with a lancet device and a slidable capillary tube which can be extended out of the casing to collect blood by capillary action. In this arrangement, the device is different from that reported in patent '492 in that the capillary tube is extended much further outside the casing to collect the blood on the skin. US patent 8,092,394 B2 awarded to Microsample Ltd. provides a prior art device that comprises a tube with a needle disposed within the tube such that when the needle moves rearward, a suction pressure is generated. The needle can be extended to lance a skin site for obtaining a blood drop, and then retracted to generate the suction pressure so that the blood can be drawn into the tube. This arrangement is similar to that reported in patent '492 except that the tube is fixed on the skin but the needle is moving forward and rearward, while in patent '492 the tube was slided to reach the blood drop.

US patent 5,014,718 awarded to Safety Diagnostics, Inc. reported a blood extraction and collection article. The prior art article required the user to use his finger to press and deform the prior art article so that the finger could reach a needle for pricking. Blood would come out and be collected in the article instantaneously without having to remove the finger. This prior art article required manual pressing of needle which may be quite painful. Current lancets use a spring to provide great speed, i.e. 1 m/s to 6 m/s, to momentarily prick the skin for attaining blood samples. The great penetrating speed reduces the pain to the rriinimum. In addition, the blood collection of the prior art article would be blocked by the finger. The user would have no clear visual access to the blood collection process and have to remove his finger to see what happened and how much blood had been collected in the prior art article. Hence, this prior art article is painful and cumbersome in collecting blood. The volume of blood could not be precisely determined too. It is a requirement that for accurate and repeatable IVD tests, the volume of the blood samples has to be exact, and none of the prior arts provide a solution.

It can be clear that the prior art does not address the blood sampling issue where blood samples are needed to be precisely quantified, collected and then dispensed into a test media for IVD testing. It should be noted that the blood sample on the pricked skin site should not be transferred direcdy to the test media because chemicals and reagents may enter the body from the breached skin site. For example, current safety lancets on the market do not have measurement and collection function. Therefore, a user has to juggle between the safety lancets, the pipette and the test devices for carrying out an IVD test. Therefore, there is a long-felt need for a safety lancet that lances a finger, collects the exact volume of the blood sample, and finally dispenses the blood sample into a test media.

SUMMARY OF THE INVENTION The present invention is related to a safety lancet incorporating a blood collection means. In the preferred embodiment, the blood collection means is a measurement and collection tube. The incorporated blood measurement and collection tube enables a user single-handedly to prick his finger with safety lancet, milk the lanced site to obtain a desirable size of blood droplet, and collect and measure at the same time the desired volume of blood with the present invention. The user ma estimate the blood volume collected in the tube by seeing the blood column's movement relative to the graduation scale on the device, and he may stop the collection process by separating the tube from the blood. Alternatively, the capillary tube may be made to have a predetermined capacity to collect only the predetermined amount of blood sample by filling up the predetermined capacity for a particular IVD test. This is particularly crucial for advanced point-of-care testing systems which provide quantitative and high accuracy results. Result accuracy often requires that the blood sample to be exact. Lastiy, the user may dispense the collected blood onto a test media by making physical contact between the tube's opening and the test media.

In the preferred embodiment, the present invention comprises (i) a casing 30, wherein the casing further comprising a first casing component 40 which is substantially flat and its inner surface 44 is incorporated with a spring compartment 48 and a collection tube holding structure 49, and a second casing component 50 which is also substantially flat and its inner surface 54 is incorporated with a collection tube holding chamber 62, a spring compartment 64 comprising a spring tab 66, a main sliding groove 68, and a pair of secondary sliding grooves 70 and 72; (ii) a needle body 80 that is slidable longitudinally, the needle body 80 further comprising a spring butt 82 at one end and a needle 84 within a protective cap 86 at the opposite end and a pair of wings 88; (iii) a spring 100 which is disposed longitudinally with one end attached to the spring tab 66 and the other end attached to the spring butt 82 on the needle body 80, wherein the spring 100 provides the potential energy when it is compressed by the needle body 80, which is converted into kinetic energy upon the release of the needle body 80; (iv) a release mechanism 120, comprising a compression surface 122, a pair of arms 124, which further comprising a pair of main hooks 126 and a pair of pusher fins 128 which engage the needle body 80 via its wings 88, and (v) a blood collection means 20 which is disposed within the casing 30 which has on opening end 22 exposed outside the casing 30 for collecting blood. It is desired that the opening end 22 of the blood collection means 20 is in the proximity of the release mechanism 120. It is particularly preferable that the opening end 22 is on the same distal end of the article 10 as the release mechanism 120. The blood collection means 20 is a capillary tube which may be made to have a predetermined capacity to collect only the predetermined amount of blood sample by filling up the predetermined capacity for a particular IVD test. The capillary tube will not take in further any blood sample even if there is still blood sample available at the tube opening once the predetermined capacity is filled up. Hence, accurate amount of blood sample Can be attained. Once the desired amount of blood sample is collected, the blood collection means 20 can be removed from the casing 30 for further processing, such as centrifuging, freezing and other analytical processes.

Yet in another preferred embodiment, the outer surface 52 of the second casing component 50 may be bored with an elongated window 58 to expose the blood collection means 20 and be inscribed with graduation scales 56 so that the user can estimate the blood volume in the blood collection means 20 and stop the collection process by separating the tube from the blood once the desired volume is attained. The blood collection means 20 may be bent at the front section so that the opening end 22 can be disposed at the same distal end as the release mechanism 120 to collect blood economically at a convenient angle. The blood collection tube 20 is a capillary tube. Again, the capillary tube may be made to have a predetermined capacity to collect only the predetermined amount of blood sample by filling up the predetermined capacity for a particular IVD test. The capillary tube will not take in further any blood sample even if there is still blood sample available at the tube opening once the predetermined capacity is filled up. Hence, accurate amount of blood sample can be attained.

In a third embodiment, the blood collection means 20 is a disposable pipette 200 comprising a tubing 220 and a bulb 240. The bulb 240 is substantially exposed outside the casing 30 so that the user can squeeze the bulb 240 and slowly release it to suck the blood into the tubing 220. After the blood is collected, the pipette 200 may be taken out from the casing 30 for subsequent analytical processes. The advantages of using a pipette 200 over a blood collection tube are that the blood volume of collection can be significandy larger and that the dispensing of blood can be carried out by squeezing the bulb 240. For capillary tube, the dispensing can only be done by contacting the opening end 22 with the test media. This is particularly troublesome if there is more than one sample dispensing because physical contact may contaminate the blood sample in the capillary tube.

In a fourth embodiment, the blood collection means 20 is a filter paper 300 which is disposed the same way the tube and the pipette 200 are disposed in the previous embodiments. Blood sample can be deposited onto the filter paper 300 and let air dry to form dried blood spot (DBS). The filter paper 300 with a stained with dried blood spot may be removed from the article 10 by pulling the tail tab 320. The dried blood spotted paper may be stored or punched to obtain smaller pieces of DBS for molecular diagnostic tests, namely DNA extraction and amplification.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 shows the perspective view of the preferred embodiment of the present invention Fig. 2 shows the inner surfaces of the first and second casing components of the present invention

Fig. 3 shows the un-boxed view of the present invention wherein all components are assembled on the inner surface of the second casing component

Fig. 4 shows the engagement of the needle body and the release mechanism

Fig. 5A shows the initial positions of the components in the casing before compression

Fig. 5B shows the compressing positions of the components in the casing during the compression

Fig.5C shows the final positions of the components in the casing after the compression

Fig. 6 shows another preferred embodiment wherein the blood collection means is a pipette Fig. 7 shows a third preferred embodiment wherein the blood collection means is a filter paper

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a safety lancet incorporating a blood collection means. As more and more point-of-care test kits are developed for home-use markets, there is an unanswered demand for a blood extraction device that allows the users to attain a desirable amount of capillary whole blood for carrying out some IVD tests at home or at the patients' privacy. The present invention is specifically developed for such requirements.

Figure 1 shows the perspective view of the preferred embodiment of the present invention, which is essentially a disposable article 10 of safety lancet incorporating a blood collection means, in this case a blood collection tube 20. It is understood by the persons skilled in the art that the blood collection means 20 covers more than a collection tube, a few more examples are a disposable pipette or a filter paper. The disposable article 10 comprises a casing 30 that is made up by two pieces of substantially flat plastic parts, namely the first casing component 40 with the outer surface 42 and the second casing component 50 with the outer surface 52 is shown in Fig. 1. There is a graduation scale 56 along a longitudinal window 58 to show a blood collection means 20 disposed in the casing 30. The graduation scale 56 can show approximate blood volumes that the blood collection means 20 collects, which can be 2.5ul, 5ul, lOul and 15ul. Normal blood volume for one IVD test can range from 2.5ul to Oul of blood. The inner diameter of the collection tube 20 can be changed if more or less blood volume range is desired. It is desired that the opening end 22 of the blood collection means 20 is in the proximity of the release mechanism 120. It is particularly preferable that the opening end 22 is on the same distal end of the article 10 as the release mechanism 120. The user can estimate the blood volume in the blood collection means 20 and stop the collection process by separating the tube from the blood once the desired volume is attained. The blood collection means 20 may be bent at the front section so that the opening end 22 can be disposed at the same distal end as the release mechanism 120 to collect blood ergonomically at a convenient angle. The blood collection means 20 is a capillary tube. The capillary tube 20 can be made to have a predetermined capacity to accurately take in exacdy a predetermined volume of blood for high precision IVD tests. Once the capillary tube 20 is full, and exact amount of blood has been collected, no further blood will be collected. Once the desired volume blood is accurately collected, the blood collection means 20 can be removed from the casing 30 for further processing, such as centrifuging, freezing and other analytical processes.

Figure 2 shows the inner surface 44 of the first casing component 40 and the inner surface 54 of the second casing component 50 of the disposable article 10. There is a male welding fin 46 disposed around the circumference of the first casing component 40, which is to be mated with the female welding fin 60 disposed around the circumference of the second casing component 50. Once the male 46 and female 60 welding fins on the first 40 and second 50 casing components respectively are mated, the assembled casing 30 is subjected to ultrasonic welding to permanently couple the two pieces together. It is only through this two-piece design that additional components such as a blood collection means or even a test media can be incorporated into a safety lancet. It is clea to the persons skilled in the art that the welding fins can come with several designs depending upon the casing material's properties and the sealing requirements. It is also clear that other fastening features 46 and 60 can be incorporated on the inner surfaces 44 and 54 to fasten the casing components 40 and 50 together using other fastening or welding techniques.

Figure 2 also shows a spring compartment 48 on the inner surface 44 of the first casing component 40. The spring compartment 48 is disposed on the first casing component 40 to reduce the overall thickness of the casing 30. It has to be understood that the spring compartment 48 can also be disposed on the second casing component 50. Lastly, there is a blood collection means holding structure 49 disposed to secure the collection means 20 in place. The blood collection means holding structure 49 is substantially the same geometry and dimensions to the blood collection means 20. The geometry in this case may be a long slender shape such as a capillary tube, or tubing which has a bulb such as a disposable pipettor, or a circular shape for filter paper. In this case, the blood collection means 20 is a capillary tube. The capillary tube may be made to have a predetermined capacity to collect only the predetermined amount of blood sample by filling up the predetermined capacity for a particular IVD test. The capillary tube will not take in further any blood sample even if there is still blood sample available at the tube opening once the predetermined capacity is filled up. The inner diameter of the capillary tube can range from 0.55mm to 1mm, depending on the collection volume. It is found that capillary tubes with inner diameters in such a range provide excellent capillary suction. It must be stressed that the blood collection means 20 is not only limited to a capillary tube but can include other articles such as a disposable pipette or a filter paper. It is also worth noting that the blood collection means 20 may be a straight tubular structure, and may not be a bent tubular structure as shown in Fig. 1— Fig. 3.

On the other hand, the inner surface 54 of the second casing component 50 further comprises a blood collection means holding chamber 62, a spring compartment 64 comprising a spring tab 66, main sliding groove 68 and a pair of secondary sliding grooves 70 and 72. The blood collection means holding chamber 62 works together with the blood collection means holding structure 49 on the first casing component 40 to store and secure the blood collection means 20 within the casing 30. It is clear that persons skilled in the art may vary the form and appearance of the holding structure 49 and chamber 62 for the purpose of storing and securing the blood collection means 20 within the casing 30. In this preferred embodiment, the blood collection means 20 is a capillary tube. The capillary tube 20 may be cut to a predetermined length so that when it is fully filled with blood it collects the exact volume of the blood which is required for high precision IVD tests.

In Fig. 2, the spring tab 66 is generally disposed at the proximal end of the spring compartment 64 on the inner surface 54 of the second casing component 50 to fasten a metal spring to the casing 30. The spring compartment 64 accommodates a metal spring in its fully extension length. The main sliding groove 68 is an elongated channel structure which allows sliding movement within the channel structure, and it is disposed longitudinally downstream to the spring compartment 64. There is a pair of secondary sliding groove 70 and 72 which are disposed at the sides of the main sliding groove 68. There is a pair of diverging slopes 74 at the proximal end of the secondary sliding grooves 70 and 72.

Figure 3 shows the inner surface 54 of the second casing component 50 loaded with other components, namely a needle body 80, a metal spring 100 and a release mechanism 120. The needle body 80 comprises a needle 84 which is over-moulded with a protective cap 86 and a spring butt 82. There are two wings 88 disposed at the lateral sides of the needle body 80 which are always in physical contact with the pusher fins 128 of the release mechanism 120. The spring butt 82 is disposed to catch the spring 100 so that the needle body 80 can be propelled and retracted by spring 100, and slide in the main sliding groove 68 longitudinally. The protective cap 86 has to be removed to expose the needle 84. The needle 84 can be moulded with advanced polymer such as poly-etherimide (PEI) while the protective cap 86 and the spring butt 82 can be over-moulded on the needle 84 using commodity plastics such as polyethylene (PE).

Figure 4 shows a release mechanism 120 comprising a compression face 122, a pair of arms 124, which further comprising a pair of main hooks 126 and a pair of pusher fins 128. When the release mechanism 120 is pushed on the compression surface 122 towards the casing 30, the spring 100 is first compressed and then released to propel the needle body 80 forward for pricking a finger at a great speed.

Figure 5A shows the original position of the release mechanism 120 and the needle body 80. The release mechanism is initially held in place with its main hooks 126 latched onto the secondary sliding grooves 70 and 72. In this position, the spring 100 is slighdy compressed, thus providing the holding force to hold the needle body 80 and the release mechanism 120 so that they do not move freely within the casing 30.

Figure 5B shows the compressing position of the release mechanism 120 when a finger is placed on the compression surface 122 and a pressure has been exerted- towards the casing 30. Upon exertion of pressure, the release mechanism 120 will slide in the secondary sliding grooves 70 and 72 towards the casing 30 via its two arms 124. As it slides inward, the pusher fins 128 which are engaged with the wings 88 on the needle body 80 will push the needle body 80 along, which further compresses the spring 100 wherein when the release mechanism 120 is pushed on the compression surface 122 towards the casing 30, the spring 100 is compressed and then released to propel the needle body 80 forward for pricking a finger at a great speed until the ends of the arms 124 reaches the .diverging slopes 74. Further compression will bend the arms 124 outwards and at certain point disengage the pusher fins 128 from the wings 88, setting the needle body 80 free from the inward compression. At the same time, the potential energy stored in the spring 100 is released and converted into kinetic energy, actuating and the retracting the needle body 80 towards the finger.

Figure 5C shows the final position after the needle body 80 has been triggered. The spring 100 is fully extended (without any compression), the release mechanism 120 is substantially pushed inside the casing 30, and the pusher fins 128 are upstream of the wings 88 on the needle body 80. In this final position, the needle body 80 will not be able to be actuated again.

Figure 6 shows a third embodiment of the present invention, wherein the blood collection means 20 is a disposable pipette 200 comprising a tubing 220 and a bulb 240. The bulb 240 is substantially exposed outside the casing 30 so that the user can squeeze the bulb 240 and slowly release it to suck the blood into the tubing 220. After the blood is collected, the pipette 200 may be taken out from the casing 30 for subsequent analytical processes. The advantages of using a pipette 200 over a blood collection tube are that the blood volume of collection can be significandy larger and that the dispensing of blood can be carried out by squeezing the bulb 240. For capillary tube, the dispensing can only be done by contacting the opening end 22 with the test media. This is particularly troublesome if there is more than one sample dispensing because physical contact may contaminate the blood sample in the capillary tube.

Figure 7 shows a fourth embodiment of the present invention, wherein the blood collection means 20 is a filter paper 300 which is disposed the same way the tube and the pipette 200 are disposed in the previous embodiments. Blood sample can be deposited onto the filter paper 300 through the opening end 22 and let air dry to form dried blood spot (DBS). The filter paper 300 with a dried blood spot may be removed from the article 10 by pulling the tail tab 320. The dried blood spotted paper may be stored or punched to obtain smaller pieces of DBS for molecular diagnostic tests, namely DNA extraction and amplification.

Claims

We claim:

1. A blood extraction device for extracting and collecting a predetermined volume of capillary whole blood from a living subject, the blood extraction device comprising:

a. A spring-operated lancing device for pricking a skin site at high speed when activated by the contact pressure of the skin site, the spring-operated lancing device further comprising a casing inscribed with graduation scale for estimating the blood volume, a needle body sliding longitudinally along the casing, a spring with one end attached to the casing and the other end fastened to the needle body, and release mechanism which is activated via contact pressure if the skin site for loading the needle body on the spring and subsequently releasing the needle body thereby providing a high speed for pricking the skin site; and

b. A blood collection means which is disposed within the casing and collects blood via capillary action from an opening end, and which dispenses blood to a test media via the same opening end by making physical contract between the test media and the opening end.

2. The blood extraction device in claim 1, wherein the blood collection means has a predetermined capacity to only collect a predetermined blood volume by filling up the predetermined capacity.

3. The blood extraction device in claim 1, wherein the blood collection means is a capillary tube.

4. The blood extraction device in claim 1, wherein the blood collection means is a disposable pipette.

5. The blood extraction device in claim 1, wherein the blood collection means is bent near the opening end which collects blood.

6. The blood extraction device in claim 1, wherein the blood collection means is a filter paper used for collecting dried blood spots.

7. The blood extraction device in claim 1, wherein the blood collection means is detachable from the casing after the blood collection is completed.

8. The blood extraction device in claim 1, wherein the casing of the spring-operated lancing device further comprising a first casing component and a second casing component, both of which are substantially flat, a. The first casing component further comprising a spring compartment, a welding fins along the perimeter of the first casing component, and a blood collection means holding structure; and

b. The second casing component further comprising a welding structures along the perimeter of the second casing component, a spring compartment, a spring tab on the spring compartment, a main sliding groove, a pair of secondary sliding grooves and a blood collection means holding chamber.

c. The first and second casing components can be coupled and then subject to a fastening process.

9. The blood extraction device in claim 7, wherein the fastening process is ultrasonic welding.

10. The blood extraction device in claim 7, wherein the fastening process is laser welding.

1 . An apparatus for extracting and collecting a predetermined volume of capillary whole blood, the apparatus comprising:

a. A spring-operated lancing device, essentially consisting of:

i. A casing, further comprising a first casing component and a second casing component, both of which are substantially flat; wherein

The first casing component further comprising an outer surface and an inner surface, the inner surface further comprising a welding fins around the first casing component, a spring compartment and a blood collection means holding structure; the second casing component further comprising an outer surface and an inner surface, the outer surface further comprising a window for showing the collected blood, and a graduation scale along the window; the inner surface further comprising a welding features around the second casing component, a spring compartment, a spring tab on the spring compartment, a main sliding groove, a pair of secondary sliding grooves, a pair of diverging slopes, and a blood collection holding chamber; ii. A needle body, further comprising a spring butt, a pair of wings and a needle; wherein the needle body is disposed and slides longitudinally in the main groove; iii. A spring with one end attached to a spring tab on the second casing component and with the other end attached to the spring butt on the needle body;

iv. A release mechanism, further comprising a compression surface, a pair of arms, a pair of pusher fins and a pair of main hooks disposed on the pair of arms; and b. A blood collection means which is disposed within the casing and collects blood via capillary action from an opening end, and which dispenses blood to a test media via the same opening end by making physical contract between the test media and the opening end.

12. The apparatus in claim 10, wherein the release mechanism is latched in its original position by the pair of main hooks latching onto the casing, which slighdy compresses the spring, but upon compression at the compression surface, the release mechanism will slide with its pair of arms on the pair of secondary sliding grooves, the pair of pusher fins on the arms engages with the wings on the needle body and pushes the needle body towards the spring thereby compressing the spring, the release mechanism is pushed until the arms reach the diverging slopes and are forced to move apart from each other, which disengages the wings of the needle body from the pusher fins, thereby releasing the needle body for pricking a skin site.

13. The apparatus in claim 10, wherein the blood collection means has a predetermined capacity to only collect a predetermined blood volume by filling up the predetermined capacity.

1 . The apparatus in claim 10, wherein the blood collection means is a capillary tube.

15. The apparatus in claim 10, wherein the blood collection means is a disposable pipette.

16. The apparatus in claim 10, wherein the blood collection means is a filter paper for collecting dried blood spots.

17. The apparatus in claim 10, wherein the blood collection means is detachable from the casing after the blood collection is completed.

8. The apparatus in claim 10, wherein the casing of the spring-operated lancing device further comprising a first casing component and a second casing component, both of which are substantiaEy flat,

a. The first casing component further comprising a spring compartment, a welding fins along the perimeter of the first casing component, and a blood collection means holding structure; and

19. The blood extraction device in claim 16, wherein the fastening process is ultrasonic welding.

20. The blood extraction device in claim 16, wherein the fastening process is laser welding.

21. A method of extracting and collecting a predetermined volume of capillary whole blood using the device or apparatus in claims 1-18, comprising:

a. Bringing a skin site and to be in contact with the compression surface of the release mechanism,

b. Applying compression pressure in between the compression surface and the skin site thereby pushing the release mechanism inward the casing until the needle body is release for pricking the skin site at a high speed,

c. Removing the pricked skin site and milking the area surrounding the pricked skin site for obtaining a droplet of capillary whole blood on the pricked skin site,

d. Bringing the droplet of capillary whole blood to the opening end of the blood collection means, wherein the blood will be sucked into the blood collection means via capillary action,

e. Observing through the window the flow of the blood in the blood collection means, f. Removing the blood droplet once the predetermined blood volume is reached.

22. The method in claim 19, wherein the skin site for pricking includes finger tips, palm edges, and forearms.