MXPA99005239A - Method and apparatus for obtaining blood for diagnostic tests - Google Patents

Abstract

Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted;and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly;and (b) a vacuum pump. Preferably, the apparatus also includes a housing. In a further aspect of the invention, a pneumatic lancing assembly is provided. The pneumatic lancing assembly uses differential gas pressure to thrust a lancet into skin tissue. In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood. The article, which contains an appropriate detection element for determining the amount of analyte in the blood, can be used in conjunction with a meter that measures the signal generated by the detection element of the article.

Description

METHOD AND APPARATUS FOR OBTAINING BLOOD FOR DIAGNOSTIC TESTS BACKGROUND OF THE INVENTION FIELD OF INVENTION This invention relates to a method and apparatus for obtaining blood samples for diagnostic purposes.

DISCUSSION ABOUT THE TECHNIQUE. The prevalence of diabetes has increased markedly in the world. At this time, diagnosed diabetics represent approximately 3% of the population of the United States. It is believed that the actual real number of diabetics in the United States is more than 16,000,000. Diabetes can lead to numerous complications, such as, for example, retinopathy, netoropathy and neuropathy. The most important factor in reducing the complications associated with diabetes is the maintenance of an adequate level of glucose in the bloodstream. Maintaining the proper level of glucose in the bloodstream can prevent and even reverse many of the effects of diabetes.

Glucose monitoring devices of the prior art have functioned on the principle of taking blood from an individual by a variety of methods, such as by needles or lancet. An individual covers a strip of paper carrying chemicals with the blood, and finally inserts the strip coated with blood into a blood glucose meter for the measurement of glucose concentration determining a change in reflectance. The prior art medical device for monitoring the level of glucose in the bloodstream required that an individual have a separate needle or lancet available to draw the individual's blood, strips carrying the blood chemicals to create a chemical reaction with respect to glucose in the bloodstream and changing the color, a blood glucose meter to read the color change that indicates the level of glucose in the bloodstream. The level of blood glucose, when measured by a glucose meter, is read from a strip that carries blood chemicals through a well-known process of reading reflectometers for glucose oxidation. Generally, the lancets comprise a razor and an oppressive end opposite thereto, the razor having a sharp end capable of being inserted into the skin of a human. When turning the oppressive potion, the sharp end of the knife will pierce the skin. For example. Of the Finger. The finger lancet is mainly used to obtain small volumes of blood, that is, less than one milliliter. Diabetics use the finger lancet to obtain blood volumes less than 25 microliters for glucose analysis. A small amount of blood from the blood test will come out of the skin. There are many small blood vessels on each finger so that a finger can be squeezed to cause a drop of larger blood to come out. The finger is one of the most sensitive parts of the body, in accordance with the above, the finger lancet leads to even more pain than would be experienced by extracting the blood via the lancet at a different body site. The finger lancet presents another problem due to the limited area available in the fingers for piercing. Since it is recommended that diabetics monitor their blood glucose levels 4 to 6 times a day, the limited area in the fingers requires repeated piercing of areas that are already injured. Because the fingers are sensitive to pain, there is a recent tendency for the arm to undergo blood sampling. See, for example, U.S. Patent No. 4,653,513. The device of U.S. Patent No. 4,653,513 comprises a cylindrical housing and a lancet holder, which has a flexible package or portion slidably accommodated in the housing. Springs will retract the lancet support to thereby reduce the air pressure in the housing so that it sucks a blood sample, automatically and immediately after the lancet pierces the skin. See also U.S. Patent No. 5, 320, 607, which discloses a device comprising a sealed vacuum chamber in a pre-existing reduced pressure state, a support member for the sealed vacuum chamber, defining the member of support a suction portion adjacent to the sealed vacuum chamber, the suction portion, in cooperation with the sealed vacuum chamber, exposing an area of the patient's skin to a state of reduced pressure when the device is activated, and accommodated within the suction portion to slightly break a portion of the skin area of the patient exposed to the reduced pressure state. Because the blood volume requirements for a standard glucose test strip are typically 3 nicroliters or more, an area of the body that can generate as much blood as that from a lancet wound should be used. It is believed that more however, that the technological improvements of the glucose test strip will reduce the necessary blood volume of 1 to 3 nicroliters. Because the finger is improvised with blood and the amount of blood can be increased by squeezing the finger after the puncture, the finger is currently the body's preferred site for puncture, when the finger is painful. A less painful technique to obtain body fluids can be found if a reliable method is found to pierce a part of the body that is less sensitive to pain than the finger and obtain a useful amount of blood from that part of the body. A part of the body such as the forearm is much less sensitive to pain than the finger, but the amount of blood resulting from the puncture procedure generally has an inadequate volume for use with current detection technology. The ways to increase blood flow to the finger are common knowledge. The recommendation made to diabetics is to put your finger under hot water before the puncture to improve the blood flow in the finger and the amount of blood collected from the finger. Leaving hot water on one part of the body to improve blood flow is not practical for areas such as the thigh or forearm. The availability of hot water is also a problem. Blood obtained from the lancet picket typically has to be manually transferred by the user of the finger to the detector. However, this manual transfer is difficult for users who are skilful, have bad eyesight or are prone to trembling (hypoglycemic diabetics). Manual transfer can also lead to errors in the determination of glucose if too much blood or too little blood is transferred. Therefore it would be desirable to develop a technique and apparatus for obtaining blood for diagnostic purposes in a painless, reliable manner. Conventional puncture devices, such as those described in United States of America patents Nos. 32,922, 4,203,446, 4,990,154 and 5,487,748, accept commercially available disposable lances. Most conventional lancet devices are not integrated with a diagnostic instrument. A conventional puncture mechanism typically consists of a housing, a guide shaft having a lancet fastener at one end, a main spring (usually elicit) that supplies the mechanical energy to axially accelerate the shaft, and a return spring that partially retracts the arrow after the puncture has been carried out. The user must first insert a lancet into the holder, then manually slide the arrow until the main spring is compressed and the arrow locks in its "cocked" position, then place the device on the skin, then press a trigger which releases the arrow, driving the lancet through the skin. The lancet is quickly retracted from the skin by the force of the return spring. Conventional puncture devices would have several disadvantages for an apparatus that combines the processes of puncture, fluid collection, and analyte uptake in an automated instrument. The first disadvantage is the need for manual cocking of the puncture mechanism before each use. Manual cocking is inconvenient for the user and generally adversely affects the characteristics of an integrated instrument. Cocking also prohibits sequential, rapid puncture of the target skin. Sequential puncture could increase the volume of biological fluid collected. The second disadvantage is that the mechanical trigger can be accidentally depressed by the user if the device is misused. The accidental firing of the lancet could hurt users and cause technical problems within an automated puncture system. The user would also have the inconvenience of having to cocking the mechanism after accidental firing. The third disadvantage is that the conventional return spring is generally not able to completely retract the lancet, due to the opposing force of the main spring. Partial retraction may subject the user to accidental punctures when handling the instrument before or after use particularly when the lancet is located near other components, such as the fluid sample collection strips. It would therefore be desirable to provide a lancing device that eliminates one or more of the above disadvantages.

SUMMARY OF THE INVENTION This invention provides a method and apparatus for extracting a blood sample from a patient for subsequent diagnostic tests, eg, glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which a blood sample is to be extracted, and (b) extracting the blood sample from the unobstructed opening in the skin, with the help of a vacuum and to stretch the skin. In a preferred embodiment of the method, step: (a) is preceded by the step of increasing the availability of blood in the portion of the skin from which the sample is to be extracted. In this preferred embodiment, the availability of blood in the skin portion from which the sample is to be extracted can be increased by means of a vacuum, which is applied to the surface of the skin in the vicinity of the opening before form the opening of the skin. The vacuum causes the portion of the skin in the vicinity of the blood collection site to fill with blood. The vacuum also causes the portion of the skin in the vicinity of the blood collection site to stretch. An opening of this stretched portion of the skin can be formed with a cutting or puncture device, for example, a lancet, or other device capable of forming an opening in the skin, for example, a laser jet, or fluid. If a cutting or puncturing device is used to form the opening, it must be retracted from the opening before the step of drawing the blood sample from the opening. This retraction will allow the unrestricted flow of blood through the opening. After the opening is formed, a vacuum is used to help draw the blood sample from the opening in the skin. The sample can be analyzed from drops of blood that are collected on the surface of the skin at the site of the opening, by applying the blood directly to a glucose detector. However, it is preferred that the sample be collected in such a manner, for example, via a capillary tube, which can be analyzed by conventional diagnostic devices, such as, for example, a biosensor. In another preferred embodiment, the sample may be collected in a collection area that is integrated with a conventional diagnostic device, for example, a biosensor. If a glucose detector is used, it must be kept stationary within the device throughout the blood collection procedure or it may be moved near the puncture site after the lancet is retracted by firing or other mechanism. In an alternative embodiment of the aforementioned preferred embodiment, the availability of blood in the area of the skin from which the blood is to be extracted can be increased by applying thermal energy to that area of the skin. The thermal energy causes the blood in the area of the skin to flow more quickly, thereby allowing more blood to be collected per given unit of time. In this alternative embodiment, steps (a) (b) can be carried out in the same manner as they were carried out in the aforementioned preferred embodiment. In another aspect of the invention, an apparatus is provided for collecting a body fluid sample for analysis in a diagnostic test, for example, blood. In a preferred embodiment, the apparatus comprises: (a) a housing; (b) a device for forming an unobstructed opening in an area of the skin from which the sample is to be extracted, preferably a puncture assembly; and (c) a vacuum pump.

It is also possible to dispense with accommodation. However, the accommodation is preferred for the convenience of the patient and the protection of the components. The vacuum pump requires a source of energy. If the apparatus includes a housing, the energy source can be provided within the housing. Alternatively, the energy source may be external to the housing. The preferred device for forming an unobstructed opening in the area of the skin from which the blood sample is to be drawn is a puncture assembly, which comprises a lancet to form an opening in the skin. Alternatively, the unobstructed opening in the skin can be formed by a laser beam or a fluid jet.

The vacuum pump can serve the dual purposes of (i) stretching the skin and (ii) increasing the removal of the blood sample from the unobstructed opening in the skin. Preferably the vacuum pump can serve the triple purpose of: (i) stretching the skin, (ii) increasing the availability of blood to the skin area from which the sample is to be extracted, and (iii) increasing the extraction of the blood sample from the unobstructed opening in the skin. Preferably, the housing further contains electronics that have programmed instructions for connecting the on-off vacuum pump to maintain the desired level of vacuum.

The apparatus preferably contains valves, such as, for example, solenoid valves, for firing the lancet from the piercing assembly and leveling the vacuum at the conclusion of the blood drawing procedure. The apparatus may optionally contain a heating element to increase the availability of blood to the area of the skin from which the blood is to be drawn. The apparatus may also contain a glucose detector integrated with the apparatus, for example, a biosensor, to analyze the blood sample collected by the apparatus. In another aspect of this invention, a puncture assembly has been developed that uses differential gas pressure to drive a lancet into the tissue of the skin. This puncture assembly effectively utilizes low pressure gas, which is preferably provided by the aforementioned vacuum pump, and high pressure gas, which is preferably provided by ambient air surrounding the apparatus, to drive the lancet, to drill the skin, and then retract the lancet from the skin to produce an unobstructed opening to allow access to the biological fluid. The puncture assembly eliminates the need to manually force the lancing mechanism into a bolt or "cocking" position, before each use, and also eliminates the need for a mechanical trigger to release the bolt to allow the lancet to be released. key in the skin. The elimination of the requirement to manually hammer the lancet mechanism allows the puncture assembly to be controlled exclusively by electronic means. These control means are desirable when used in conjunction with an automatic instrument, or when a series of continuous puncture steps are desired. The puncture assembly using differential gas pressure comprises: (a) a fastener for holding a lancet assembly; (b) an element for providing sufficient force to cause the fastener to be held in a position whereby the lancet assembly on the fastener would be placed away from the patient's skin; and (c) an element for allowing a gas that provides sufficient force to overcome the force provided by the fastener-holding member, whereby the gas causes the fastener to move to a position whereby a lancet in the fastener would be able to pierce the patient's skin. In one embodiment, the puncture assembly comprises a housing, a lancet holder, a piston for moving the lancet holder, a gap in which the piston moves toward and away from the target skin tissue., an element for deflecting the piston, for example, a return spring or a bellows, from the target skin tissue, and a cap. The housing has a manifold in which 3-way valves can be adjusted. The 3-way valve selectively allows high pressure from an external source to the housing to pass through the inlet port to a hollow port, whereby the level of the pressure in the well is increased. The air pressure in the hole drives the piston into the targeted skin tissue while simultaneously compressing the piston bypass element. The piston is stopped by the cap or by the structure in the instrument designed to limit the penetration depth of the lancet into the skin. The 3-day valve then directs the air into the gap to flow out through an outlet port to a source of low pressure air, for example, an air cavity evacuated in the apparatus, thereby causing the level of the pressure in the gap decreases, and consequently allowing the piston deflection element to force the piston back into its position prior to driving into the recess. In another aspect, this invention provides an article capable of both collecting blood and detecting an analyte in that blood. Preferably, the article is also capable of measuring the amount of the analyte in the blood. The article, which contains a suitable detection element for determining the amount of the analyte in the blood can be used together with a meter that measures the signal generated by the detection element in the article. In one embodiment, the article is a multi-layered element comprising: (a) a layer capable of receiving blood and transporting the blood received by means of a chemically aided wick; (b) a layer capable of detecting the presence of the analyte or measuring the amount of the analyte in the blood; and (c) a layer that can be brought into contact with a meter, the layer that can be brought into contact with the meter superimposed on the blood transport layer, the layer (a) being capable of transporting blood to the layer (b) In a preferred embodiment, the article is a multi-layered element comprising: (a) a cover layer having an opening therein; (b) a layer, superimposed on the cover layer, capable of receiving blood through the opening in the cover layer and transporting blood by means of chemically assisted capillarity; (c) a layer that can be brought into contact with a meter, superimposed on the layer that can be brought into contact with the meter in the layer that carries the blood; and (d) a layer capable of detecting the presence of analyte or measuring the amount of analyte in the blood, this layer is disposed between the cover layer and the layer that can be brought into contact with the meter and is capable of receiving blood of the layer that carries blood. An optional dust jacket layer can be interposed between the cover layer and the cover that can be brought into contact with the meter to restrict the flow of blood in the blood-carrying layer. In another embodiment, the layer that carries blood can be removed. In this embodiment, the layer that can be brought into contact with the meter and the cover layer uses capillary action to transport the blood by capillary flow to the detection layer. In order to use the multi-layer element, a vacuum is used to stretch the skin and pull the skin to bring it into contact with the cover layer of the element. The vacuum is applied for a period of time sufficient to cause blood to accumulate in the stretched skin. Then an unobstructed opening is formed in the skin, typically by a retractable lancet. The blood leaves the unobstructed opening in the skin and enters the blood transport layer. The opening in the cover layer makes it possible for blood leaving the unobstructed opening in the skin to enter the blood transport layer. The blood then moves along or through the blood transport layer to the detection layer. Preferably, the detection layer comprises an electrochemical sensor or an optical sensor. A chemical reaction occurs on the surface of the detection layer. The result of the chemical reaction can then be read by a meter. The multi-layer element integrates the blood transport layer, the layer that can be contacted with the meter, the detection layer, and, when employed, the cover layer on an element. This integrated element can be made at a cost low enough to be disposable. The multi-layer element makes it possible to obtain accurate results with small blood samples, because no blood is spilled during the transfer of blood to the detection layer. The multi-layered element can capillary out the blood emerging from the unobstructed aperture formed in the skin and direct the blood to the detection layer of the multi-layered element where a diagnostic test is made, such as, for example, the measurement of the analyte concentration, for example, glucose, in the blood. The transfer of blood by manual means is not required. The detection layer can also be used to send a signal to the blood collection apparatus of this invention to release the vacuum when sufficient blood has been drawn into the multi-layer element to provide a reliable diagnostic test. The multi-layer element can also be used as a barrier to stop the lancet assembly to control the depth of the unobstructed opening formed in the skin. The method and apparatus of this invention provide several advantages over other methods and apparatuses of the prior art. First, a sufficient amount of blood can be extracted from parts of the body, other than the finger, to carry out glucose monitoring tests. Second, by making other parts of the body convenient for drawing blood, the use of a painful finger lancet can be avoided. Third, by increasing the availability of blood from the site from which the blood is to be drawn, the period of time required to draw the sample may be reduced. Because of these advantages, the diabetic patient is more likely to monitor blood glucose levels at the intervals prescribed by their doctor.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a plan view of the components of a preferred embodiment of the apparatus of this invention. In this Figure, the housing cover was removed. Figure 2 is a schematic diagram illustrating how a vacuum causes a portion of the skin to stretch prior to the formation of an opening in the skin from which the blood sample is drawn. Figure 2 also illustrates the spatial relationship between the tip of the lancet assembly and a glucose detector, for example, a biosensor. Figure 3 is a block diagram illustrating the electronics of the preferred embodiment. Figure 4 is a schematic diagram illustrating an alternative seal for the vacuum of the device of the present invention. Figure 5 is a perspective view of one embodiment of the apparatus of this invention. In this figure the housing of the device is open. Figure 6 is a perspective view of one embodiment of the apparatus of this invention. In this figure the housing of the device is open. Figure 7 is a perspective view of one embodiment of the apparatus of this invention. In this figure the housing of the device is open. Figure 8 is a perspective view of one embodiment of the apparatus of this invention. In this figure the housing of the device is open.

Figure 9 is a perspective view of one embodiment of the apparatus of this invention. In this figure the housing of the device is open. Figure 10 is a perspective view of one embodiment of the apparatus of this invention. In this figure the housing of the device is open. Figure 11 is an elevated, cross-sectional view of one embodiment of the puncture assembly of this invention in assembled configuration. Figure 12 is an exploded view, in cross section, of the puncture assembly of Figure 11. Figure 13 is a schematic diagram illustrating the placement of the components of the puncture assembly of this invention. In this Figure, the lancet assembly has not yet been inserted into the lancet holder and the valve has not yet been inserted into the valve manifold. Figure 14 is a schematic diagram illustrating the placement of the components of the puncture assembly of this invention. In this Figure, the lancet has been inserted into the lancet holder and the valve has been inserted into the valve manifold. Figures 15a, 15b and 15c are schematic diagrams illustrating the puncture assembly of this invention in a position prior to puncture, puncture position and post-puncture position, respectively. Figure 16 is a cross-sectional elevated view of another embodiment of the puncture assembly of this invention in assembled configuration. Figure 17 is an exploded view, in cross-section, of the puncture assembly of Figure 16. Figure 18 is an elevated cross-sectional view of another embodiment of the puncture assembly of this invention in assembled configuration. Figure 19 is an exploded view, in cross-section, of the puncture assembly of Figure 18. Figure 20 is a cross-sectional elevated view of the puncture assembly of the invention installed in an embodiment of an apparatus of this invention. . Figures 21a and 21b are exploded perspective views of a multi-layered element for collecting blood and detecting an analyte. Figure 21b is an exploded and flayed perspective view. Figure 22 is a top plan view of one embodiment of a multi-layer element wherein the blood transport layer is a fine mesh. Figure 23 is a bottom plan view of the embodiment of the multilayer element of Figure 22.

Figure 24 is a top plan view of one embodiment of a multi-layer element wherein the blood transport layer is a coarse mesh. Figure 25 is a top plan view of an embodiment of a multi-layer element wherein the blood transport layer is a fine mesh having an opening formed therein. Figure 26a is a top plan view of one embodiment of a multi-layer element wherein the blood transport layer is a fine mesh. The layer that can be put in contact with the meter has two holes punched in it. Figure 2b is a top plan view of one embodiment of a multi-layer element wherein the blood transport layer is a fine mesh. The layer that can be put in contact with the meter has a single opening in it. Figure 27 is a top plan view of one embodiment of a multi-layer element in which the blood transport layer is embedded in one end of the element. Figure 28 is an exploded elevated view of a multi-layer element of this invention. Figures 29a, 29b, 29c and 29d schematically illustrate a method by which the method of this invention is carried out with the multilayer element of this invention. Figure 30 is a graph illustrating the average electrical load as a function of the blood glucose level. Figure 31 is a graph illustrating the pain of the lancet in the forearm compared to the pain of the lancet in the finger. Figure 32 is an elevated cross-sectional view of a preferred embodiment of a tip of this invention. Figure 33 is a series of elevated cross-sectional views of various convenient tip patterns for use in this invention. Figures 34A, 34B, 34C and 34D are schematic diagrams of the placement of the tip of the apparatus of this invention in relation to the puncture assembly, the stop element, and the skin prior to the application of the vacuum, during the application of the vacuum, during puncture, and during blood collection and analysis, respectively. Figure 35 is a series of elevated cross sectional views of various convenient tip patterns for use in this invention.

Figure 36 is a graph illustrating the effect that various tip patterns have on the time of filling a detection element. Figure 37 is a graph illustrating the average time to fill a multi-layer element as a function of the tip used. Figure 38 is a graph illustrating the full percentage, as a function of the tip used. Figure 39 is a series of raised views of cross sections and top plan views of various convenient tip patterns for use in this invention. Figure 40 is a graph illustrating the air flow velocity as a puncture of the tip used. Figure 41 is a graph illustrating the average volume of blood collected as a function of the material used to make the seal of the tip assembly. Figure 42a, is an elevated cross-sectional view of a preferred embodiment of a tip of this invention, wherein the seal is in a first position. Figure 42b, is an elevated view of the tip of Figure 42a, wherein the seal is in a second position.

Figure 43, which comprises of Figures 43a through 43c, represents a perspective view of one embodiment of the apparatus of this invention. From Figure 43a, 43b, the housing of the apparatus is open. In Figure 43c, the housing of the apparatus is closed. Figure 44 comprises Figures 44a and 44b, represents a perspective view of one embodiment of the apparatus of this invention. In Figure 44a, the housing of the apparatus is open. In Figure 44b the housing of the apparatus is closed. Figure 45, which comprises of Figure 45a through Figure 45e, depicts a partial cross-sectional drawing of one embodiment of the apparatus of this invention. In Figure 45a, the housing of the apparatus is open. In Figure 45b, the housing of the apparatus is partially open. In Figure 45c to 45e, the housing of the apparatus is closed. Figure 46, which comprises from Figure 46a through 46c, represent a partial cross-sectional drawing of one embodiment of the apparatus of this invention. In Figure 46a to 46c, the housing of the apparatus is closed. Figure 47 is a diagram indicating blood collection results for one embodiment of the apparatus of this invention.

Figure 48 is a diagram indicating blood collection results for one embodiment of the apparatus of this invention. Figure 49 is a diagram indicating blood collection results for one embodiment of the apparatus of this invention.

DETAILED DESCRIPTION The embodiments of this invention require that the following steps be carried out, the function of obtaining a blood sample to carry out diagnostic tests, for example, glucose monitoring: (a) a housing having a sealable chamber located therein and a sealable opening in fluid communication in the sealable chamber. (b) an energy source, (c) a vacuum pump operably connected to the power source, in communication the vacuum pump with the sealable chamber, (d) a puncture assembly positioned within the sealable chamber, capable of puncture assembly moving a lancet towards the sealable opening, and (e) fluid collector placed in the sealable chamber, the fluid collector in fluid communication with the sealable opening.

An unobstructed opening in the area of the skin from which the blood sample is to be drawn is formed by a piercing device or some other type of device capable of forming an unobstructed opening in the skin. Convenient piercing devices for this invention include, but are not limited to, mechanical puncture assemblies. Other types of devices capable of forming an opening without obstruction in the skin include, but are not limited to, lasers and fluid jets. Other types of fluids capable of forming an unobstructed opening in the skin can be used, and this description should not be considered as limited by the devices listed. Mechanical puncture assemblies are well known in the art. These assemblies comprise standard steel lancets, steel devices, and multiple point devices. The lancets can be made of metal or plastic. Multi-tip devices provide redundancies which can reduce the number of failures and increase the volume of blood drawn. Lasers suitable for forming an unobstructed opening in the skin for drawing blood is known in the art. See, for example, U.S. Patent Nos. 4,775,361, 5,165,418, 5,374,556, International Publication Number WO 94/09713 and Lane and Contributors (1984) Research Report of IBM-Research Report - "Ultraviolet-Laser Ablation of Skin", all of which are incorporated herein by reference. The loops that are convenient to form an unobstructed opening in the skin include Er: YAG, Nd: YAG and semiconductor lasers. The fluid jets suitable for forming an unobstructed opening in the skin employ high pressure fluid jet, preferably a saline solution, to penetrate the skin. Regardless of what type of device is used to form an unobstructed opening in the skin, the opening formed by the device must be unobstructed. As used herein, "unobstructed," means free from capping, obstruction, blocking, or closing by an obstacle. More specifically, the terms "unobstructed opening in the skin area in which the sample is to be extracted", "unobstructed opening in the skin", and the like are meant to mean that the portion of the opening below the surface of the skin does not have any foreign object that would cover, hinder, block or close the opening, such as, for example, a needle of some kind. For example, if a lancet is used to form the opening, it must be retracted from the opening before starting the blood draw. Because lasers and fluid jets do not require contact with the skin to form openings in the skin, these types of devices typically provide unobstructed openings. However, these expressions are not intended to include foreign objects on the surface of the skin or on top of the surface of the skin, such as, for example, a glucose monitor. This feature, ie, the unobstructed aperture, can be compared to the aperture used in the method and apparatus described in U.S. Patent No. 5,320,607, in which the piercing and cutting element remains in the skin during the duration of the blood collection period. By leaving the opening unobstructed, blood can be drawn much faster out of the opening than would be removed if the piercing and cutting element were allowed to remain in the opening. In addition, the requirement of an unobstructed opening exposes the body to a foreign object either at all or only a very short period of time, which is welcomed by the patient. The step of extracting the blood sample from the opening in the skin is carried out by a combination of extraction enhancement elements. Extraction enhancement elements suitable for use in this invention include, but are not limited to, vacuum, skin stretch elements, and heating elements. It has been found that when these elements are used in combination, the volume of blood drawn increases greatly, particularly when a vacuum is applied in combination with skin stretching. In this combination, the vacuum not only causes the blood to be quickly removed from the unobstructed opening by suction, it also causes a portion of the skin in the vicinity of the opening to stretch. The stretching of the skin can be carried out by other means, such as mechanical means or adhesives. Mechanical means include devices for pinching or pulling the skin; the adhesives carry out the stretching of the skin by means of pulling it. It is preferred to use a vacuum to effect the stretching of the skin. As a vacuum, the heating element operates more effectively in combination with other techniques, for example, stretching of the skin. This characteristic, that is to say, the element of increase of the extraction, can be compared with the system described in the patent of the United States of North America number 5,279,294, in which these elements of increase of extraction are not used nor the system described in European Patent Applications 0351892 and 0127958, wherein the sensor is either a needle-like nature or fits inside a hollow needle. In the preferred embodiment of this invention, step (a), the step of forming the unobstructed opening, is preceded by the step of increasing the availability of blood in the area of the skin from which the sample is to be extracted. The availability of blood in a given area of the skin can be increased by at least two methods. In one method, blood can be used to flow through the blood vessels to accumulate in the area of the skin where the vacuum is applied. In another method the heat can be used to cause blood to flow through the blood vessels to flow more quickly in the area of the skin where the heat is applied, thereby allowing a greater amount of blood to be extracted from the site. of blood extraction per unit of time. Although the step of increasing the availability of blood in the vicinity of the blood collection site is not required, the use of this step may result in a greater volume of blood drawn. The elements for increasing blood availability at a blood collection site that are convenient for use in this invention, include, but are not limited to, vacuum, localized heating element, skin stretching element, and chemicals. As stated above, by applying a vacuum in the area of the skin from which blood will be drawn, the availability of blood under and within the skin at the site of application can be increased. The vacuum can also be used to stretch the skin upwards in a chamber, whereby the accumulation of blood under and inside the skin is increased. This combination of vacuum and skin tightening may be an extension of the combination used to draw blood from the opening in the skin, as previously described. It is well known that heat can increase the large-scale perfection of a limb or a finger. Chemical elements, such as histamine, can be used to cause a physiological response to increase perfusion under and inside the skin. In the preferred embodiments of the invention, the extracted blood is also collected. The step of collecting the blood sample can be carried out in a variety of ways, using a variety of fluid collectors, for example, the blood can be collected in capillary tubes or on absorbent paper. Alternatively, the blood can be allowed to remain in the lancet assembly, from which it can be used directly in a diagnostic test. More preferably, the blood sample is collected in the application zone of a glucose detector, from which it can be used directly to provide an indication of the concentration of glucose in the blood. This glucose detector can be held stationary within the device throughout the blood collection procedure or can be moved near the puncture site, after the lancet is retracted by a trigger or other mechanism. The apparatus of the present invention may contain more than one fluid connector. A sensor package containing a plurality of blood glucose sensors is described in EPO 0732590A2. Regardless, the way in which the blood sample is collected, the sample can be analyzed at a later time than at the time of collection or in a remote place from the collection site or both. A preferred embodiment of the invention will now be described in detail. Referring now to Figure 1, the blood collection device 10 comprises a housing 12. Arranged within the housing 2 is a vacuum pump 14, a puncture assembly 16, a battery 18, and electronics 20. A switch 22 is provided. to activate the electronics 20. The housing 12 is preferably made of a plastic material. It is preferably of sufficient size to contain all the components that are required to form an unobstructed opening in the area to the skin from which the blood sample is to be drawn, drawing the blood sample from the unobstructed opening in the skin. , preferably with the aid of a vacuum and a stretching of the skin, and collecting the extracted sample in an amount sufficient to carry out the diagnostic test. The methods for preparing the housing 12 are well known to one skilled in the art. As stated above, housing 12 is not required, but is preferred for the convenience of the patient and the protection of the components. The vacuum pump 14 should be capable of providing a vacuum that will provide sufficient suction to stretch the portion of the skin in the region from which the blood sample is to be drawn. Typically, the stretched skin portion is raised a distance of one to 10 mm, preferably 3 to 5 mm, from the plane of the part of the body to which it belongs. According to the suction provided by the vacuum pump 14 is stretching the suitable portion of skin, the suction provided by the vacuum pump 14 also causes the stretched portion to fill with blood. The level of suction provided must be sufficient to cause a relatively large volume of blood to accumulate at the point at which the vacuum is applied. The vacuum pump 14 should also be able to provide sufficient suction to draw blood from the opening in the skin at a rate sufficient to extract at least one microliter of blood within a period of 5 minutes. A vacuum pump 14 which is convenient for the device of this invention can be a diaphragm pump, a piston pump, a rotary valve pump, and any other pump that will perform the required functions presented previously. Typically, the vacuum pump 14 employs a self-contained permanent magnet direct current motor. Vacuum pumps that are convenient for this invention are well known to those skilled in the art and are commercially available. A convenient vacuum pump for use in the present invention is available from T-Squared Manufacturing Company, Nutley, MJ, and has part number T2-03.08.004. The vacuum pump 14 is preferably capable of providing a pressure of up to about 14.7psig. and more preferably is operated at from about minus 3.0psig. up to about 10 Opsig. The skin area subject to vacuum preferably ranges up to about 50 cm2, more preferably from approximately 0.1 to approximately 5.0 cm2. The period of the vacuum application before forming the skin opening, that is, to increase the availability of blood at the application site, preferably varies up to about 5 minutes, preferably from about one to about 15 seconds. The period of application of vacuum subsequent to the formation of the opening in the skin, ie, to aid in the extraction of blood from the unobstructed opening, preferably varies up to about 5 minutes, preferably from about one to about 60 seconds. The vacuum provided by the vacuum pump 14 may be continuous or pulsed. A continuous vacuum is preferred for the reason that it requires fewer components than a pulse vacuum. It is preferred that the applied vacuum does not cause irreversible damage to the skin. It is preferred that the applied vacuum does not produce scratches and discolorations in the skin that persist for several days. It is also preferred that the level of vacuum applied and the duration of the application of the vacuum is not excessive so as to cause the dermis to separate from the epidermis, which would result in the formation of a blister filled with fluid. The vacuum pump feature offers significant advantages over the method and apparatus described in U.S. Patent No. 5,320,607, in which a sealed vacuum chamber in a pre-existing reduced pressure state is used. The use of a vacuum pump gives the user greater control of blood draw conditions than does the sealed vacuum chamber in a pre-existing reduced pressure state. For example, energy can be supplied to the vacuum pump to achieve a higher level of vacuum, thereby providing greater suction. The puncture assembly 16 comprises at least one lancet. Normal lancets may be used in the puncture assembly of this invention. Narrow-size lancets (28 to 30 gauge) are preferred. Lancets suitable for this invention can be made of metal or plastic. Suitable lancets for this invention may have single points or multiple points. The depth of penetration of the lancet preferably varies from about 0.4 to about 2.5mm, more preferably from about 0.4 to about 1.6mm. The length of the lancet or lancets preferably varies from about .mu.m to about 5mm. The puncture assembly is preferably located so that the user can easily replace the used lancets. The lancet of the puncture assembly 16 can be assembled manually or automatically, for example, by means of a vacuum-activated piston or diaphragm. The lancet of the puncture assembly 16 can be triggered manually or automatically, for example, by means of a piston or vacuum-activated diaphragm. Puncture assemblies are well known in the art. Representative examples of puncture assemblies suitable for this invention are described in United States Patent Numbers Re. 32,922, 4,203,446, 4,990,154 and 5,487,784, all of which are incorporated herein by reference. A particularly convenient puncture assembly for this invention is described in United States Patent No. Re. 32,922. However, any selected puncture assembly should operate in conjunction with the other features of the apparatus of this invention. For example, if a vacuum is used, the puncture assembly should be designed so that the vacuum can be formed and pulled through the assembly. The puncture assembly can be designed to allow automatic assembly and automatic triggering of the lancet. Although conventional puncture assemblies are suitable for use in this invention, a puncture assembly has been developed that uses differential gas pressure to drive a lancet into the skin tissue for use with this invention. As used herein, the term "differential gas pressure" means the difference in gas pressure between a source of gas at a high pressure, for example, ambient air or pressurized air and a source of gas at a low pressure, for example, air inside a vacuum. In any case, the pressure of a gas source at high pressure exceeds the pressure of the gas source at low pressure. Figures 11, 12, 13, and 14 illustrate one embodiment of a convenient puncture assembly for use in this invention. In this mode the gas is air. However, it should be noted that other gases, eg, nitrogen, carbon dioxide, can be used in place of air for the low pressure gas source, the high pressure gas source, or both. The puncture assembly 60 of this embodiment comprises a housing 62, and piston 64 having a lancet fastener 66, a lancet assembly 67 comprising a lancet 67a, inserted in a body 67b, a piston deflection member 68, the which, in this embodiment, is a return spring and a cover 70. The housing 62 has a manifold 72, in which a 3-way valve 74 can be adjusted. See Figures 13 and 14 for how to place the 3-way valve 74 in the manifold 72. The 3-way valve 74 selectively allows air from a source external to housing 62 passes through an inlet port 76 to a hollow port 78, thereby causing the level of pressure in gap 80 to increase. The increased pressure in the recess 80 causes the piston 64 to be keyed towards the target skin tissue while compressing the return spring 68. The piston 64 is stopped by the cap 70 or by another structure designed to limit the depth of penetration of the lancet 67a into the skin. Another structure may be a glucose detector in the form of a test strip, which will be described later, or a lancet arrestor, such as that designed by reference numeral 39 in Figure 2. The 3-day valve 74 then directs the air in the gap 80 to flow through an outlet port 82 to a source of low pressure air, eg, an evacuated air cavity, in the apparatus, thereby causing the pressure level in the hollow 80 decrease and consequently allowing the return spring 68 to go to the piston 64 back to its position before nailing into the hollow 80. It is necessary to make the appropriate size of the components to satisfy both the dimensional limitations of the apparatus and the the performance requirements of the puncture process, as further explained below. The puncture assembly of this invention occupies no more space than a conventional spring-driven device and typically requires less distance for the lancet to travel. The recess 80, typically cylindrical in shape, is the chamber in which the differential air pressure is generated to drive the piston 64 towards the skin tissue. The recess 80 also functions to guide the piston 64 towards the target skin tissue, while operating a low friction pneumatic seal against the O-ring 84. The ring at 0 84 is desirable to prevent high airflow. pressure is expelled from the recess 80 during the puncture procedure, because the high pressure air exhaust will decrease the air pressure level in the recess 80, with the result that the riveting speed of the piston 64 would be reduced. That the manifold 62 is shaped to conform to the 3-way valve 74, which selectively connects the hollow port 78 either to the inlet port 76 or to the outlet port 82 to direct the air flow to or from the well 80. The outlet port 82 is typically plumped to a source of low pressure air. The inlet port 76 typically is plumbed to a source of air pressure greater than that of the low pressure air source. Ports 76, 78, and 82 are positioned to communicate with the corresponding ports of the 3-way valve 74, and are preferably sized to cause less flow resistance than the 3-way valve ports 74. The piston 64 is the movable component of the puncture assembly 60. Preferably it is cylindrical in shape and has a lancet fastener 66 and a circumferential sleeve 83 for a standard O-ring 84. The lancet fastener 66 is designed to securely mount a lancet assembly. disposable 67, which is inserted by the user in the same manner as is customary with a conventional puncture device. The lancet assembly 67 comprises a lancet 67a, which is inserted into a molded plastic body 67b. The function of the O-ring 84 is to act as a seal to maintain air pressure in the gap 80 during puncture. The O-ring should cause a negligible sliding friction force along the gap 80 (negligible in comparison with the forces of the pressure acting on the piston 64). The length of the arrow 64a of the piston 64 is chosen to provide a desired stroke distance, typically from 5 mm to 25 mm. The larger dimension of the upper surface 64b of the piston 64, typically 5mm to 10mm in diameter for a cylindrical piston, is chosen to provide adequate surface air for the pressing forces driving the piston 64 and the lancet assembly 67. The return spring 68, typically a metal licoidal spring, is compressed between the piston 64 and the lid 70. The spring 68 forces the piston 64 to its maximum depth in the gap 80, when substantially no differential air pressure exists in the hollow 80. This action suitably positions the piston 64 to begin the puncture process. This position of the piston 64 is the position in which the piston 64 is furthest away from the tissue of the target skin when the apparatus is placed against the target skin tissue. The spring 68 also retracts the lancet assembly 67 in the lancet holder 66 away from the target skin at the end of the puncture process. The force of the spring must be sufficient to overcome the weight of the piston-lancet system, plus the sliding friction of the O-ring 84. The cover 70 is securely placed in the housing 62. The cover 70 appropriately places the return spring 68 at the same time providing sufficient radial space so that the spring 68 is compressed freely. The lid 70 has a passage 88 through which the lancet holder 66 can be moved. The lid 70 can also function to assist in guiding the piston 64 toward the tissue of the targeted skin. Figures 15a, 15b, and 15c, illustrate an installation of the puncture assembly of Figures 11 and 12 inside a hypothetical device 91. The puncture assembly 60 is fixed inside a cavity 92 of the apparatus 91 and fitted with a valve. 3-way solenoid 74 and a standard 93 disposable lancet assembly as shown. The lancet assembly 93 comprises a lancet 93a, which is inserted into a molded plastic body 93b. The apparatus 91 has a lower passage 94 through which the lancet assembly 93 can be moved to form an unobstructed opening in the skin "S" which is surrounded by a circular opening 94a (shown by the dotted line) in the passageway. lower. A side port 95 on a wall 96 of the apparatus 91 connects the inlet port 76 in the puncture assembly 60 to the ambient air surrounding the apparatus 91. The apparatus 91 also has a vacuum source 97 to maintain the air pressure in the cavity 92 at the level which operates the apparatus, no voltage source 98 to selectively activate the 3-way solenoid valve 74. With the voltage turned off, the 3-way solenoid valve 74 connects the recess 80 of the puncture assembly 60 with the cavity 92 via the outlet port 82, causing the piston 64 not to experience air differential air pressure. In the "ready" mode (Figure 15a), the lower passage 94 of the apparatus 91 is placed through the objective skin. The vacuum pressure of the device reaches the operating level UV weight, which is substantially less than the ambient pressure Index weight A (for example Pv = 7.5 psig, Pa = 0 psig) .. The target skin is pulled partially towards the lower passage 94 by vacuum pressure Pv. The voltage of the 3-way solenoid valve 74 is initially turned off, thereby preventing ambient air from entering the assembly 60, allowing the return spring 68 to hold the lancet 93a, at its maximum distance (eg, 10mm) of the skin. In the "throw" mode (Figure 15b), the 3-way solenoid valve 74 is activated by the voltage source 98, which allows the ambient air to flow continuously through the side door 95 of the apparatus 91 through the port of inlet 76, then through hollow port 78 in recess 80 of puncture assembly 60. The flow of ambient air increases the air pressure in recess 80, causing a differential air pressure to act on the piston 64. The differential air pressure acting on the piston 64 rapidly increases and exceeds the opposing force of the return spring 68 and the friction of the ring at 0 84, causing the The combined mass of the piston 64 and the puncture assembly 93 (for example 1.5 grams.) is keyed to the target skin. The lancet 93a contacts the skin in a short period of time (e.g., 6 msec) and achieves sufficient velocity (e.g., 3.5 meters per second) to form an opening in the skin and penetrate to a specific depth (e.g. , 1.5 mm.). The opening of the skin is completed when the nailing movement of the puncture assembly 93 is stopped by some stop element. Suitable means for stopping the puncture assembly 93 include, but are not limited to, the cap 70 within the puncture assembly 60, which, in effect, limits the stroke distance of the piston 64, and a lancet retainer, as will be described in Figure 20. In the "return" mode (Figure 15c), the lancet 93a begins to retract from the skin when the solenoid voltage is turned off, which occurs after a previously defined delay time (e.g. , 10 msec). With the voltage turned off, the 3-way solenoid valve 74 reconnects the recess 80 to the outlet port 82 in the puncture assembly 60 via the recess port 78, causing the air in recess 80 to vent quickly, (e.g., 15msec) ) through the 3 way solenoid valve 74 and out of the outlet port 82 in the cavity 92, which contains air at low pressure, providing in the apparatus by the vacuum source 97.

During ventilation, the compressed return spring 68 overcomes the combined force of the differential air pressure and the friction of the ring at 0 84 to move the piston 64 and the lancet assembly 93 back to the starting position. The puncture cycle, which requires a total of 25 msec. in this hypothetical device, it is completed in this way. The solenoid is driven by the voltage system of the device. Each time the voltage is turned on and then turned off, (ie, a pulse), the 3-way solenoid valve 74 is internally switched, first directing the air flow to the puncture assembly 60 and then away from the puncture assembly. 60. This commutation causes the lancet to be keyed into the target skin tissue, then retracted away from the targeted skin tissue. By pushing the solenoid repeatedly with voltage, the puncture process is repeated, this characteristic has been called "Repetitive puncture". The resulting opening formed in the skin is similar to that achieved with conventional puncture devices; this opening is capable of allowing a volume of biological fluid (e.g., 3 microliters of capillary blood) to be displayed for analysis. The puncture process illustrated in Figures 15a, 15b, 15c, can be repeated as many times as necessary using the same lancet and without disturbing the device or the target skin. With the skin still held in place by the vacuum suction, the solenoid voltage can be driven as necessary to 'launch the target area more than once. Repetitive puncture has two potential benefits. First, it can be coordinated with a classification system in the apparatus to launch a matrix of sites in the target skin for additional access to the biological fluid. Then, Second, you can increase the speed of puncture success in or near a single site, by sequentially launching into the skin until the desired amount of blood is obtained. Figures 16 and 17 illustrate another embodiment of the puncture assembly. In these Figures, the reference numerals with premium (ie, the reference numerals 60 ', 62', 64: ', 64a', 64b ', 66', 70X 72X 76X 78X 80X 82X 82 ') indicate components that are identical or at least substantially similar to the components designated by the same reference numerals but without a * mark (ie, reference numerals 60, 62, 64, 64a, 64b, 66, 70, 72, 76, 78, 80 , 82, 82) in Figures 11 and 12. In Figures 16 and 17 the bellows 89, typically joins the cylindrical molded elastomer, functions both as a pneumatic seal for the recess 80 'as a means to deflect the piston 64'. The bellows 89 effectively replaces the ring seal at 0 84 and the return spring 68 shown in Figures 11 and 12.

To accommodate the bellows 89, the arrow 64a, of the piston 64 ', must have a radial cross-sectional dimension sufficiently smaller than that of the recess 80' to provide sufficient space for the bellows 89. A plate 90 holds and seals the bellows 89. to arrow 64a 'of piston 64, and provides an element for guiding piston 64' through gap 80 '. A cover 70 'and a housing 62' have the shape for securing and sealing the base of the neck 89 as shown. This embodiment can be used in a manner identical to the modality shown in Figures 11, 12, 13, 14, 15A, 15B and 15C. It is clear that the embodiment employing the bellows 89 offers the potential advantage of reduced sliding friction when compared to the modality employed by the ring at 084. The bellows is not rubbed against the surface of the shaft in the manner in which it does so the ring at 0; therefore, the bellows can result in a reduced frictional force. The friction force has the undesired effect of reducing the speed of the piston. It is also clear that the bellows requires less dimensional tolerance to accommodate in the recess 80 'than is required to accommodate the ring in 084 in recess 80. The bellows do not need to be precisely adjusted in the recess, as the O-ring needs. The gap fits too tightly around the O-ring, then excessive sliding friction can result. If the gap fits loosely around the ring at 0, then excessive air leakage may result. By using the bellows instead of the O-ring, manufacturing tolerances in the gap can be relaxed, with the result that manufacturing costs will be reduced and fewer parts will be rejected. The bellows 89 is preferably made of a material having sufficient stiffness and sufficient flexibility so that the bellows can perform the following functions: (1) act as a seal; (2) resist radial collapse under pressure; (3) allowing the puncture assembly to retract to its position before nailing after the nailing step and; (4) cause its force to be overcome by the differential gas pressure during the operation. Figures 18 and 19 illustrate another embodiment of the puncture assembly. In these Figures, double reference numerals x (ie, reference numerals 60 '', 62 '', 64 '', 64a '', 64b '', 66 '', 68 '', 70 '', 72 '', 76 '', 78 '', 80 '', 82 '', 88 '') indicate the components that are identical or at least substantially similar to the components designated by the same reference numerals, but without marking them with ? s (i.e., reference numerals 60, 62, 64, 66, 70, 72, 76, 78, 80, 82, 88) in Figures 11 and 12. In Figures 18 and 19, a diaphragm 84a, it typically joins molded elastomer, it functions as the pneumatic seal for hole 80 ''. The diaphragm 84a, in effect, replaces the ring seal at 0 84 shown in Figures 11 and 12. The diaphragm 84a, is fixed to the housing 62"and the arrow 64a" of the piston 64"and can be flexed within the hollow 80"when the arrow 64a" of the piston 64a "moves axially in the recess 80 'To accommodate the diaphragm 84a, the arrow 64a" of the piston 64"must have a sufficiently small radial cross-sectional dimension that of the gap 80"to provide sufficient space for the diaphragm 84a. In addition, the housing 62"and the upper portion 62a" of the housing must have assembly features to which the diaphragm 84a can be installed. The assembly characteristics must also effectively seal the diaphragm 84a between the housing 62"and the upper portion 62a" of the housing. The diaphragm 84a is preferably secured to the arrow 64a '' of the piston 64 '' by means of a fastener 83a. This modality can be operated in a manner identical to that of the modality shown in Figures 11-17. The diaphragm 84a is preferably made of a material having sufficient strength and flexibility to perform the following functions: (1) act as a seal; (2) resist rupture under pressure during the operation of the puncture assembly; (3) allowing the lancing assembly to key a lancet into the skin of a patient; and (4) allow the puncture assembly to retract to its position prior to nailing after the nailing step, the components of the puncture assemblies in Figures 11-19 must be of shape and size to conform to the available dimensional sheath for the puncture assembly. Proper design of the components is also an important factor in achieving acceptable puncture results in the skin. Other important factors are the performance of the 3-way valve, (ie the resistance to the flow of the valve and the switching time) and the air pressure environment in which the puncture assembly operates, as discussed later.

The components for constructing the puncture assembly are commercially available, and a person skilled in the art would be expected to have sufficient skill to select the appropriate components from commercially available sources. The puncture results are believed to be influenced by three main parameters: (1) the speed of the lancet during impact with the skin; (2) the inertial mass of the lancet / piston combination of the puncture assembly and; (3) the shape and size of the lancet needle. The third parameter is not attacked by the puncture assembly of this invention because the assembly is expected to work with most commercially available lancet assemblies, such as the brands: "BD ULTRA-FNE" (Becton-Dickinson) and " ULTRATLC "(MediSense). The first and second parameters are greatly affected by the geometrical shapes and the weights of the components in the puncture assembly, although the precise influence of the speed of the lancet and the inertial mass in the performance of the puncture are not well understood . However, good puncture performance has been observed with conventional devices, which have an inertial mass typically of 1.0 grm. to 2.0 grms. , and that give a maximum lancet speed that goes from 3 meters / per second to 5 meters per second. A general mathematical expression that relates the speed of the lancet to the design of the puncture assembly and the pressure environment can be formulated from physical laws as follows: M * a (t) = A * [Pc (t) - Pv (t)] - Ks * [x (t) + Xs 093 - Ff (t) where t = elapsed time, M = total inertial mass (piston + lancet assembly), a (t = translation acceleration of the lancet in time = t Pc (t) = air pressure acting on the upper surface of the piston at time = t Pv (t) = air pressure opposite to the action of the piston = t A = projected surface area of the piston on the one that acts Pc (t) and Pv (t) Ks = constant of speed of the return spring x (t) = translation displacement of the lancet in time = t Xs = initial displacement of the return spring Ff ( t) = frictional force of the piston seal in time = t Pc (t) -Pv (t) = Differential Pressure Level that accelerates the piston in time = t The solution of the expression above for the displacement of the lancet (x) against the time (t) for which the velocity of the lancet can be determined as a function of time, requires many auxiliary equations in the field of thermodynamics and compressible flow, which it incorporates design details of the invention and the 3-way valve. In general, the speed of the lancet, (UP) at the moment of impact on the skin, can be expressed in terms of the following variables: Up = F [A, M, S, Xp, Ks, Xs, Cv, Dtv , Vc, Vv, Pa, Pv, Ta, Ff] where: A = effective surface area of the piston on which the air pressure acts; M = Total inertial mass (piston + lancet assembly) S = Piston stroke distance, Xp = lancet displacement when the impact with the skin occurs (XP <S). Ks = speed constant of the return spring. Xs = initial displacement of the return spring. Cv = flow coefficient of the 3-way valve when activated. Dtv = Switching time of the 3-way valve (time to fully activate it). Vc = initial air volume between the piston and the 3-way valve. Vv = volume of the initial cavity of the apparatus (ie, volume due to the cavity before activation of the lancet). Pa = Pressure level of the high pressure air source. Pv = Initial pressure level of the apparatus cavity (ie, measured pressure of the low pressure air source prior to the activation of the lancet). Ta = Air temperature level. Ff = Friction force profile of the piston seal (typically varies as a function of piston displacement). Maximize the speed of the lancet within a specific stroke distance of the piston (s) is carried out by selecting a 3-way valve with high coefficient of flow (Cv) and fast switching time (Dtv), optimizing the surface area of the piston (A) and the initial air volume between the piston and the 3-way valve (Vc), minimizing the total inertial mass (M), the spring force (Ks, Xs), and the friction force profile of the piston seal (Ff), ensuring adequate initial cavity volume (Vv), and applying as much differential pressure (Pa-Pv), as the device allows. The puncture assembly using differential gas pressure offers several advantages over conventional puncture assemblies. The advantages appear using differential gas pressure instead of a compressed spring to drive the lancet into the skin. An advantage is that the lancet does not need to be manually assembled by the user before use. This simplifies the use and allows the sequential puncture of the target skin to provide greater access to the blood. Assembly is not required because the gas providing the differential gas pressure escapes from the puncture assembly after use, thereby allowing the piston deflection member to force the lancet back into its original position. Another advantage is that the puncture assembly does not need to be fired mechanically. This simplifies the design of the device and protects against accidental triggering by the user if the device is misused. A separate trigger mechanism is not required because the differential gas pressure works both to start and to run the puncture process. Still another advantage is that the puncture assembly completely retracts the lancet when the puncture is not being performed. This minimizes the puncture of the user to the sharp lancet when handling the device preparing it for use or after use. The complete retraction of the lancet is carried out by a piston deflection element, after the gas that provided the differential gas pressure has been vented from the puncture assembly. Returning to Figure 1, the vacuum pump 14 is connected to the lancing assembly 16 by an evacuation tube 24. The air that is evacuated from the lancing assembly 16 by the vacuum pump 14 is removed via the evacuation tube 24. The evacuation tube 24 is typically made of a polymeric material. A check valve 26 is placed between the vacuum pump 14 and the lancing assembly 16 at a point in the evacuation tube 24 to prevent air removed from the lancing assembly 16 by the vacuum pump 14, flowing back to the puncture assembly 16 and adversely affect vacuum. A power source for the vacuum pump 14 may be disposed within the housing 12. A convenient power source for the device of this invention is a battery 18. Alternatively, an external power source can be used to operate the vacuum pump 14. The power source is activated by the electronics 20, which, in turn, are activated by the switch 22. The electronics 20 can incorporate a microprocessor or microcontroller. The function of the electronics 20 is to connote the power on and off to operate the various components in the apparatus. These components include, but are not limited to, the vacuum pump 14. The electronics 20 can also be used to interrupt the power on and off to operate components in alternative modes, for example, heating elements, lancets, indicator devices, and valves. Convenient electronics for this invention are the "TATTLETALE MODEL 5F" data controller / recorder, commercially available from Onset Computer Corporation, 536 MacArthur Blvd. P.O. Box 3450, Pocasset, Massachusetts 02559-3450. Auxiliary electronic devices such as power transistors, pressure monitors, and operational amplifiers (OP-Amps), may also be required in order to provide an interface between the controller and the operating components. All electronics required for this invention are well known to one skilled in the art and are commercially available. The auxiliary electronic devices suitable for use in this invention include the following components Figure 3 illustrates by means of a block diagram in which way the foreign electronic components can be accommodated to carry out the method of the present invention. The operation of the blood collection device 10 will now be described. Referring now to Figures 1, 2 and 3, the tip 30 of the puncture assembly 16 is applied to the surface of the skin, designated herein by the letter "S". The end of the tip 30 which contacts the skin is equipped with a seal 32. The purpose of the seal 32 is to prevent air from escaping in the extraction chamber 34, so that the vacuum pump 14 can provide sufficient action of suction to increase the availability of blood to the area of skin from which the sample is to be drawn, by stretching the skin, and extracting the blood sample from the unobstructed opening in the skin. The seal 32 surrounds an opening 33 in the tip 30. The opening 33 in the tip allows communication between the surface of the skin and a blood extraction chamber 34 in the tip 30. The seal 32 is preferably made of a rubber or an elastomeric material. Figure 4 illustrates an alternative position for seal 32. In Figure 4, the seal is designated by reference numeral 32 '. The remaining parts of Figure 4 are the same as those of Figure 2, and, in accordance with this, retain the same reference numerals as used in Figure 2. It has been found that an improved design and construction of the tip 30 It can provide increased collection of blood from the unobstructed opening in the skin. In Figure 2 it is shown that the inner walls of the tip have an essentially cylindrical shape. Although this design is capable of providing adequate performance in the method of this invention, it has been found that by changing the construction of the interior cavity of the tip, blood collection can be accelerated.

A tip assembly 3000 is illustrated in Figure 32. Tip assembly 3000 comprises a tip 3001 and a seal 3002. Tip 3001 comprises an inner base 3004 having an opening 3005 therein. Above the lower base 3004 is an upper base 3006 having an opening 3007 therein. The characteristics of the exterior of the tip, other than the lower base 3004 and the upper base 3006, are not critical to the invention, and one skilled in the art can design the outer walls of the tip in any manner that does not adversely affect the operation. of the tip of this invention. The characteristics of the interior of the tip, the lower base 3004, the upper base 3006, and, in some cases the seal 3002 are critical and consequently, will be described in greater detail. An inner wall 3008 encloses a cavity 3010 of the tip 3001. It is critical that the inner wall 3008 of the tip 3001 be structured in a manner in which the opening 3007 in the upper base 3006 has an area equal to or smaller than the opening 3005 that in the lower base 3004. It is desired that the area of the base 3004 be reduced to a size as small as possible, but not so small as to interfere with the collection of blood by a glucose monitor (see Figure 2) or with the trajectory of a lancet. An optional fastener ring 3002 may be surrounded by the opening 3007 in the upper base 3006.

There are several ways to cause the opening 3007 to be smaller than the area of the opening 3005. As shown in Figure 32, the inner wall 3008 can be decreased to a reduction in the area of the opening 3007. The decrease can begin at any point along the inner wall 3008 of the tip 3001. If the decreased portion runs the entire way from the beginning of the decreased portion to the upper base 3006, the optional adjustment ring 3012 will have a depth of 0, and so it will be eliminated from the tip. Alternatively, the area of the opening 3007 can only be made smaller than the area of the opening 3005, such as through the use of stepped cylindrical sections. Ports 3014 and 3016 can be included in nose 3001 to give cavity 3010 more exposure, if necessary. In order to more accurately describe the construction of the tip assembly 3000, 32 reference points designated by alphabetic letters have been placed in Figure, so that the typical distances between these reference points can be described. The optional adjustment ring 3012 has a depth designated by the "ab" line. This depth typically varies from 0 to 1.5mm, preferably from 0 to approximately l.Omm. The opening 3007 of the upper base 3006 has a larger dimension designated by the "cd" line. The area of the opening 3007 typically ranges from about 1 to about 500mm2, preferably from about 1 to about 150mm2. The opening 3005 in the lower base 3004 has a larger dimension designated by the "ef" line. The area of the opening 3005 typically ranges from about 10 to about 500mm2, preferably from about 50 to about 150mm2. The distance from the lowest point of the adjusting ring 3012 to the lowermost point of the seal 3002 (hereinafter "distance from the ring to the seal") is designated by the line "bg". This distance typically varies from about 1.5 to about 8.0 mm, preferably from about 3 to about 6 mm. It is preferred that the distance be selected so that the skin, when stretched toward the tip 3001, is as close as possible to the ring 3012 or to the upper base 3006 of the tip 3001. If the ring 3012 is not present, the point "d" will be located at the level of the upper base 3006. The thickness of the seal 3002 is represented by the line "eh". The width of the sealing surface and the width of the sealing surface of the lower base 3004 are designated by the line "hj". A technician with ordinary experience would have enough experience to optimize the dimensions of the tip without proper experimentation. Additional details regarding tip 3001 and seal 3002 are discussed in the examples. This improved tip has several advantages. The improved design and construction of the tip can provide for increased collection of blood from an unobstructed opening in the skin. In addition, the tip provides a better seal to the body of the tips previously used. A better seal reduces the amount of vacuum leakage with the result that a less expensive vacuum pump can be used. In addition, the improved tip allows a seal to be held over individuals who fill excessive hair on the skin. A particularly preferred tip type may have a seal of the type shown in Figure 42a and 42b in cross section, hereinafter known as a flexible seal. The flexible seal makes contact with a larger area of the skin which makes a flat seal. The flexible seal can then cause more skin to be brought into the inner space of the tip when the vacuum is applied than a flat seal does. The flexible seal can be made of silicone, 40a durometry, the flexible seal 3020 can be attached to the tip 3022 by mechanical union 3024 by means of an adhesive. The portion 3026 of the flexible seal that is not attached to the tip 3022 is capable of moving in one position, as shown in Figure 42a, and a second position as shown in Figure 42b. In the first position, the unattached portion 3026 of the flexible seal 3020 is dependent on the lower base 3028 of the tip 3022 as shown in Figures 42a. In the second position, the unattached portion 3026 of the flexible seal 3020 is brought into contact with the lower base 3028 of the tip 3022 so that a larger surface of the unattached portion of the seal is in face-to-face contact with the lower base 3028 from the tip, as shown in Figure 42b. The flexible seal is made of a material that has a coefficient of friction that reduces the tendency of the skin in contact with it to slip. The seal should be sufficiently flexible so that it can move between the first position and the second position and sufficiently rigid to keep the skin in a stationary position. The opening 3030 in the flexible seal has an area greater than the area of the opening 3032 in the lower base 3028 and the tip 3022, when the flexible seal is in the first position, as shown in Figure 42a. In operation, the flexible seal is placed against the patient's "S" skin. The area of the skin in contact with the flexible seal is greater than the area of the opening in the lower base of the tip. Consequently, the volume of the skin raised at the tip is greater than the volume of the skin that would be lifted at the tip with a flat seal. In this way, the flexible seal would be beneficial for a patient who has a skin flexibility below normal.

The switch 22 is activated, typically by pressing it, thereby activating the electronics 20, which start the vacuum pump 14. The vacuum pump 14 then provides a suction action. The suction action of the vacuum pump 14 causes the skin surrounded by the vacuum 32 to fill with blood. The blood filling of the skin is accompanied by the stretching and lifting of the skin up towards the opening 33. After a suitable period of time, which is typically set in advance by the electronic programmer, the puncture assembly 16 it is triggered, thereby causing the puncture lancet 36 that has risen through the opening 33 to be filled with blood. The lancet 36 is preferably triggered automatically, by a solenoid valve 38 which causes a vacuum-activated piston (not shown) to trigger the lancet 36. The lancet 36 is then retracted, preferably automatically. After that, the blood flows out of the unobstructed opening resulting from the lancet 36, and, aided by the vacuum generated by the vacuum pump 14, is collected. When enough blood has been collected or after a predetermined time interval has elapsed, the electronics 20 cause the vacuum pump 14 to stop. The device 10 can then be removed from the surface of the skin after another solenoid valve (not shown because it is hidden under the solenoid valve 38) opens to vent the vacuum to allow for easy removal of the device from the surface of the skin. Solenoid valves, suitable for use with the apparatus described herein, are commercially available from The Lee Company, Essex, CT and have part number LNDA0511111H.

The blood is preferably collected directly from the application of a glucose detector, for example, a reflectance strip or a biosensor. The blood can then be used as a sample for a determination of blood glucose concentration. Alternatively, the blood can be collected by other devices, such as, for example, a capillary tube or an absorbent paper. The apparatus of the present invention may include a glucose detector for analyzing the blood sample drawn by the apparatus. Glucose detectors are well known in the art. With respect to glucose monitoring, there are two important categories of glucose detectors -reflectometers and biosensors. Representative examples of reflectometers suitable for this invention are described in U.S. Patent No. 4,627,445, incorporated herein by reference. Representative examples of suitable biosensors for this invention are described in U.S. Patent No. 5,509,410, incorporated herein by reference. The glucose detector preferably, at the tip 30 of the lancet assembly 36. The glucose detector should be detected in a position sufficiently close to the blood collection site, so that the amount of blood collected collected is sufficient to perform a standard glucose monitoring test. Typically that distance will preferably be no more than 5 mm from the blood collection site, more preferably no more than 3 mm from the blood collection site, more preferably no more than 1 mm from the blood collection site. Alternatively, the glucose detector can be maintained at a distance greater than 5mm from the blood collection site until shortly after the lancet is fired, preferably, approximately 50 milliseconds, but at least enough to allow the lancet to retract . If the glucose detector is placed in this manner, then it can be triggered, for example, by a solenoid valve causing a vacuum-operated piston that triggers the glucose detector. Other trigger mechanisms can also be used. The trigger action pushes the glucose detector towards the skin, preferably not more than 5 mm from the blood collection site, more preferably, 3 mm from the blood collection site, much more preferably not more than 1 mm from the blood collection site. Care must be taken in the glucose detector so that the detector does not adversely affect the vacuum, when a vacuum is used to aid in the extraction of blood. In addition, the glucose detector should be modified, if necessary, so that blood collected in the collection area of the glucose detector is capable of being used to activate the glucose detector. Figure 2 also illustrates a way to dispose a glucose detector 40 at the tip 30 of the lancing assembly 16. One embodiment of the glucose detector 40 of this invention involves a multi-layer element comprising: (a) A layer capable of receive blood and transport the blood received through capillary aided chemically; (b) A layer capable of detecting the presence of the analyte or measuring the amount of the analyte in the blood; and (c) A layer that can be brought into contact with a meter, the layer that can be brought into contact with the meter superimposed on the test transport lid, capable of layer (a) of transporting blood to the layer (b). ).

A preferred embodiment of the glucose detector 40 of this invention involves a multi-layered element, which comprises: (a) A cover layer having an opening therein; (b) A layer, superimposed on the cover layer, capable of receiving blood through the opening in the cover layer and transporting the blood by means of chemically assisted capillarity; (c) A layer that can be brought into contact with a meter, the layer that contacts the meter superimposed on the blood transport layer; and (d) A layer capable of detecting the presence of the analyte or measuring the amount of analyte in blood, this layer is arranged between the cover layer and the layer that can be brought into contact with the meter and is capable of receiving blood from the blood transport layer. Figures 21a and 21b illustrate the aforementioned preferred embodiment of the multi-layer element of this invention. During the course of the discussion of this modality, a modality that does not require a cover layer will also be discussed. The multi-layer element 1100 comprises a cover layer 1102 having an opening 1104 therein. To a larger surface 1106 of cover layer 1102 a layer 1108 capable of transporting blood by means of capillarity chemically aided to a detection layer 1110 is adhered. The other major surface 1112 of cover layer 1102 is the surface that is put on. close proximity with or even in contact with the skin. The superimposed layer 1110 is a layer that can be brought into contact with the meter 1114 having an opening 1116 therein. The opening 1104 in the cover layer 1102 and the opening 1116 in the layer that can be brought into contact with the meter 1114 are aligned so that the lancet can pass through the opening 1104 and through the opening 1116 to perforate the skin. The blood transport layer 1008 can be designed to allow the lancet to pass through it or it can be positioned so that the lancet does not need to pass through it. The opening 1004 in the cover layer 1002 allows the blood transport layer 1008 to collect blood that leaves the opening in the skin, by the lancet, so that the blood from that opening in the skin can be transported by means of the of a capillary action chemically assisted to the detection layer 1110. The detection layer 1110 can be arranged on a larger surface of the cover layer 1002 or on a larger surface of the layer that can be brought into contact with the meter 1114 The detection layer 1110 comprises a layer or layers of chemicals, for example, an enzyme layer, capable of reacting with an analyte in a biological fluid to produce either a measurable electrical response or a measurable optical response. Patents of the United States of North America numbers 4,545,382; 4,722,245; and 5,682,884; all of which are incorporated herein by reference, describe, detection layers capable of generating a measurable electrical signal, in response to blood glucose. U.S. Patent Nos. 4,935,346 and 4,929,545, both incorporated herein by reference, disclose detection layers capable of producing a measurable change in reflectance in response to blood glucose. An example of a detection layer is described in U.S. Patent No. 5,682,884. The detection layer described in U.S. Patent No. 5,682,884 comprises a first conductor and a second conductor that extends along a support and further comprises an element for the connection for the reading circuit. An active electrode, placed to contact the liquid blood sample and the first conductor, comprises a reservoir of an enzyme capable of catalyzing a reaction involving the analyte compound, eg, glucose, in the liquid blood sample. The electrons are transferred between the catalyzed reaction above and the first conductor to create the current. A reference electrode is placed to contact the liquid blood sample and the second conductor. The cover layer 1102 is preferably formed of a hydrophobic material. The cover layer is preferably flexible enough to conform to the remaining layers of the multi-layer element. Representative examples of materials that are suitable for preparing the cover layer include, but are not limited to, polymeric materials, such as polyesters, polyimides, polyethylenes, polypropylenes, polycarbonates, polyacrylics, and combinations thereof. The thickness of the cover layer 1102 is not critical, but preferably varies from about 0.005 mm to about 2.0 mm. The surface dimensions of this layer are not critical, but the larger surface dimension preferably ranges from about 5mm to about 60mm and the smaller surface dimension preferably varies from about 2mm to about 30mm. The layer is shown as elongated and rectangular, but other shapes are also convenient, for example, circular, elliptical, triangular, square, and other shapes. The size of the opening 1104 in the cover layer 1102 must be large enough to allow a lancet to pass therethrough to the patient's skin. It is preferred that the aperture 1104 be large enough for a commercially available lancet to be used. Because commercially available lancet assemblies vary in how precisely the lancet is centered within the lancet assembly body, opening 1104 in cover layer 1102 is preferably large enough to allow passage of the lancet, but not so large that it compromises the resistance of the cover layer. Typically, the opening 1104 is not greater than half or three quarters of the width of the cover layer 1102. Although the embodiment in Figures 21a and 21b shows a cover layer, it is possible, but not preferred, to dispense with the layer of deck completely. In embodiments that dispense with the cover layer, the layer that can be brought into contact with the meter may have an opening therein, through which the lancet may pass.; alternatively, a sufficient amount of the layer that can be brought into contact with the meter can be trimmed so that the lancet will avoid hitting the end of the layer that can be brought into contact with the meter before forming an opening in the skin. In this latter embodiment, the blood transport layer may or may not have an opening therein, through which the lancet may pass.

The transport layer 1108, preferably, is made of polymeric material, cellulosic material, natural fibrous material, or an equivalent material. Representative examples of polymeric materials suitable for the blood transport layer of this invention, include, but are not limited to, polymers comprising monomeric amide units, eg, naylon, monomeric ester units, alkylene monomer units, example, polypropylene, polyethylene, monomeric cellulose units, and combinations thereof. The layer that carries blood can be a mesh. The mesh is preferably constructed of finely woven yarns of polymeric material, however, any woven or non-woven material can be used, provided that the blood-carrying layer carries the blood to the detection layer 1110 before the blood evaporates or coagulates. A fine mesh that is suitable for the multi-layer element of this invention, has an open area percentage of from about 40 to about 45%, a mesh count of from about 95 to about 115 fibers per centimeter, a fiber diameter from about 20 to about 40 microns, and thickness from about 40 to about 60 microns. A particularly preferred mesh is NY64 HC mesh available from Sefar (formerly ZBF), CH-8803, Ruschlikon, Switzerland. A coarse mesh which is suitable for the multiple layer element of this invention has a percentage of open area of from about 50 to about 55%, a mesh count of from about 45 to about 55 fibers per centimeter, a fiber diameter of from about 55 to about 65 microns, and a thickness of from about 100 to about 1000 microns. A preferred mesh is NY151 HC mesh, available from Sefar (formerly ZBF) CH-8803, Ruschlikon, Switzerland. The Characteristics of the mesh are further described in U.S. Patent No. 5,628,890, incorporated herein by reference. The blood transport layer 1108, carries blood by means of a chemically aided capillary action. As used herein, the term "chemically aided capillarity action" refers to either: (a) the flow of a fluid along a material where the nature of the material itself is hydrophilic, such as, for example, example, cellulose; (b) the flow of the fluid along a material wherein at least one chemical substance is applied to the surface of the material, such as, for example, nylon coated with surfactant; (c) the flow of the fluid along a material that has become hydrophilic by means of a chemical or physical process, such as, for example, treatment of the polyester by means of corona discharge treatment, plasma treatment, treatment by flame, or similar. The purpose of the at least one chemical applied to the surface of the material of the blood transport layer is to promote the flow of the fluid along the surface of the material. Chemicals suitable for the above purpose belong to the class of compounds commonly known as surfactants. Surfactants reduce the surface tension of the surface on which they are coated and allow the coated surface to attract instead of repelling fluids. A commercially available surfactant suitable for use in that invention is a morochemical surfactant having the trade designation "FC 170C FLUORAD", available from the Minnesota Mining and Manufacturing Company, St. Paul, Minnesota. The surfactant is a solution of a fluoroaliphatic oxyethylene adduct, lower polyethylene glycols, 1,4-dioxane and water. It has been found that about 1 to 10 micrograms of surfactant is preferred per milligram of blood transport layer. The preferred surfactant filler may vary depending on the nature of the material of the blood transport layer and the surfactant used. The preferred amount can be determined empirically or by observing the flow of the sample along the blood transport layer with different load levels of surfactants. The surfactant, it may not be necessary if the mesh is made of hydrophilic material. The blood transport layer 1108 is capable of allowing a sufficient quantity of blood to flow uniformly therethrough at a rate sufficiently large that a sufficient amount of blood, for example, 0.1 to 10 microliters, preferably up to 2 microliters, more preferably up to 1 microliter, reach the detection layer 1110 before evaporation causes the sample size to be inadequate to provide a reading of the analyte level within a reasonable time, i.e., up to 5 minutes. The blood transport layer 1108 can be adhered to the cover layer 1102, by means of hot melt adhesive or on the larger surface of the cover layer facing the layer that can be brought into contact with the meter 1114. The blood transport layer 1108 may have a small opening formed therein, aligned with the path of the lancet and aligned with the openings in the cover layer 1102 and the layer that may be brought into contact with the meter 1114, thus eliminating the possibility of the lancet hitting a mesh fiber during the puncture operation. The cover layer 1102 and the blood transport layer 1108 are preferably arranged so that the blood leaving the opening in the skin is not prevented from reaching the blood transport layer by the cover layer. In Figures 21a, 21b, 22, 23, 24, 25, 26a, 26b, and 27, arrangements for the cover layer 1102 and the transport layer 1108 suitable for use in this invention can be seen. It should be noted that Figure 23 does not show a cover layer, but it should also be noted that Figure 23 represents the opposite side of the multi-layer element of Figure 22. As shown in Figures 21a and 21b, the multi-layer element it has an opening 1104 formed in the cover layer 1102 and an opening 1116 formed in the layer that can be brought into contact with the meter 1114. The blood transport layer 1108 is disposed between the cover layer 1102 and the layer that is may contact the meter 1114. In Figures 22, 23, 24 and 25, the blood-carrying layer 1108 is disposed directly over the opening 1104 in the cover layer 1102. In the detection layer, the electrical contacts are represent by the part that has the reference numeral 1110a. In Figure 13, the blood-carrying layer 1108 is disposed directly below the opening 1116 in the layer that can be brought into contact with the meter 1114. In Figures 22 and 23, the blood-carrying layer is a mesh that has a relatively large number of openings per unit area. In Figure 24, the blood transport layer is a mesh having a relatively small number of openings per unit area. In the embodiments shown in Figures 22, 23 and 24, there is a possibility that the lancet will stick to one of the fibers of the mesh during the skin opening step of the process. If the lancet strikes one of the fibers, the moving mass should have enough momentum to puncture the fiber and the skin beneath it. The momentum of the moving mass is a function of the mass and velocity of the movement components of the puncture assembly. The resistance of the blood transport layer with respect to the perforation will also determine the effectiveness of the puncture. The thickness and properties of the layer material that carries blood will determine its strength. It is preferred that the thickness and properties of the mesh material be such that a commercially available lancet can pierce the mesh. In Figure 25, the blood carrying layer 1108 is disposed between the cover layer 1102 and the layer that can be brought into contact with the meter 1114 and disposed directly below the opening 1104 in the cover layer 1102; however, the blood carrying layer 1108 also has an opening 1118 formed therein. In the embodiment shown in Figure 15, there is no possibility of the lancet sticking to one of the fibers of the mesh during the skin opening step of the process. As shown in Figure 26a, the layer that can be contacted with the meter 1114 has two openings 1116 and 1122 formed therein. The blood transporting layer 1108 is displaced from the opening 1116 and directly over the opening 1122. In this embodiment, the lancet passes through the opening 1116 to form the opening in the skin. Then, some type of mechanical device, for example, a spring, a solenoid, a pivot, or a 4-bar entangle, causes the multi-layered element to move at a sufficient distance so that at least a portion of the layer which carries blood 1108 is substantially directly over the opening formed in the skin, thereby minimizing the distance that the blood needs to travel to reach the layer carrying blood 1108 and at the same time eliminate the possibility of the lancet hitting a mesh fiber during the puncture operation. The opening 1122 in the layer that can be brought into contact with the meter directly aligned with the blood carrying layer 1108, can be applied for vacuum selection to increase blood collection. However, it should be noted that this opening is optional and can be dispensed with in other modalities. See, for example, Figure 26b, in which only one opening is formed in the layer that can be brought into contact with the meter. In Figure 27, the blood carrying layer 1108 abuts one end 1121 of the multi-layer element. In the embodiment of Figure 27, a lancet passing through the semicircular opening 1104 may strike a mesh fiber during the puncture operation. The blood leaving the opening formed in the skin has to travel a minimum distance to reach the layer carrying blood 1108. Alternatively, after a lancet has formed an opening in the skin, the multi-layer element can be moving in the manner described above to facilitate collection of blood by the blood carrying layer 1108. The detection layer 1110 preferably comprises an electrochemical detector, for example, a biosensor, or an optical detector, for example, a reflectance detector. The detection layer 1110 is supported either on the cover layer 1102 or on the layer that can be brought into contact with the meter 1114.

The detection layers of the electrochemical type are preferably non-porous. The detection layers of the optical type are preferably porous. It is preferred that the detection layer be flexible, so that it conforms to any layer to which it is applied, the cover layer 1102 or the layer that can be brought into contact with the meter 1114. The detection layers of the electrochemical type They can be transparent or non-transparent. The detection layers of the optical type are preferably reflective. The detection layer 1110 contains the reagents required for the chemical reaction required to provide an indication of the concentration or presence of the analyte. In the case of glucose monitoring, these reagents include, but are not limited to, ferrocene, ferricyanide, glucose oxidase, glucose dehydrogenase and perioxidases. The detection layers of the electrochemical type, preferably, comprise a selected member consisting of carbon, platinum, gold, palladium, silver chloride, and silver. The detection layers of the reflectance type preferably comprise a member selected from the group consisting of dyes and enzymes. As stated above, a typical detection layer comprises a first conductor and a second conductor that extends along a support and further comprises an element for connection to the reading circuit. An active electrode, placed to contact the liquid blood sample and the first conductor, comprises a reservoir of an enzyme capable of catalyzing a reaction involving the analyte compound, eg, glucose, in the liquid blood sample. The electrons are transferred between the reaction catalyzed by the above and the first conductor to create the current. A reference electrode is placed to contact the liquid blood sample and the second conductor. In a preferred embodiment, a detection layer for the multilayer element of this invention, an electron mediator, for example, a ferrocene, is included in the deposit of active electrodes to effect the transparency of electrodes. The compound that is being detected is glucose and the enzyme is glucose oxidase or glucose dehydrogenase. The active electrode and the reference electrode are coatings applied to the cover layer 1102 or to the layer that can be brought into contact with the meter 1114. For example, the active electrode is formed by printing (for example, by printing with a screen) an ink which comprises a conductive compound, the above, and the mediator, and the reference electrode is also formed by printing (for example, by screen printing). The elements for connecting to the reading circuit are placed towards one end of the cover layer 1102 on the layer that can be brought into contact with the meter 1114, and the electrodes are placed away from that end. Further variations of the above embodiment are described in U.S. Patent No. 5,682,884 incorporated above. The layer that can be brought into contact with the meter 1114 preferably is made of a polymeric material. Representative examples of polymeric material suitable for preparing the layer that can be contacted with the meter include polymers comprising acrylic monomer units, methacrylic monomer units, acrylate monomer units, methacrylate monomer units, vinyl chloride monomer units, and combinations of the previous ones. Other suitable polymers for preparing the layer that can be contacted with the meter include polyesters. The functions of the layer that can be brought into contact with the meter are (1) to provide a surface on which the detection layer 1110 is imposed, (2) to provide alignment of the opening or openings of the multi-layer element with the lancet, (3) provide contact of the multi-layered element with the meter for the purpose of reading the signal from the detection portion of the multi-layered element(4) provide a rigid layer so that the multi-layered element can easily be collected and placed in contact with the meter, and, in the case of a detector that measures an optical response, provide a surface to contact it against a meter, which contains a light source and an element for reading the glucose signal of the detection layer. The size of the opening 1116 in the layer that can be brought into contact with the meter 1114 should be large enough to allow a lancet to pass therethrough to the patient's skin. It is preferred that the opening 1116 be large enough for a commercially available lancet to be used. Because commercially available lancet assemblies vary in precisely how the lancet is centered within the lancet assembly body, the opening 1116 in the layer that can be brought into contact with the gauge 1114 is preferably large enough for passage. of the lancet, but not so large that it compromises the resistance of the layer that can be put in contact with the meter. Typically, the opening 1116 is not greater than half or three quarters of the width of the layer that can be contacted with the meter 1114. Although the layer that may be contacted with the meter typically, the opening 1116 does not is greater than half or three quarters of the width of the layer that can be brought into contact with the meter 1114.

Although the layer that can be brought into contact with the meter 1114 is shown in Figures 21a and 21b, it deploys an opening 1116, it is possible, but not preferred, that it dispenses with the opening 1116, while sufficient amount of the layer that is may contact the meter 1114 to be trimmed so that a lancet avoids hitting the end of the layer that can be brought into contact with the meter before passing through the opening 1104 in the cover layer 1102. In this embodiment , the layer carrying blood 1108 may have or may not have an opening therein. The following table lists the convenient ranges for the dimensions of the layers of the multi-layer element of this invention. It is not intended that the dimensions of the layers of the multilayer element of this invention be limited to the ranges listed in the following table.

The multi-layer element is preferably sufficiently rigid so that it can be easily handled by the user. In the preferred embodiments, either in the cover layer 1102 or the layer that can be brought into contact with the meter 1114 or both of these layers are made of a material that is sufficiently rigid to support the blood transport layer 1108 and the detection layer 1110. The last two mentioned layers can be extremely flexible and of minimal stiffness. The porosity of the layers of the multi-layer element depends on the placement and functionality of the layers. The cover layer 1102 and the layer that can be contacted with the meter 1114 are preferably sufficiently non-porous to form a well or chamber for blood. The blood carrying layer 1108 is preferably sufficiently porous to allow blood to flow uniformly and rapidly through it to the detection layer 1110. The porosity of the detection layer is not critical; It can be porous or non-porous depending on the design selected by the manufacturer. The surface dimensions, for example, length, of the blood carrying layer 1108 are preferably smaller than those of the layer in which the detection layer 1110 is printed, so that in the case of electrochemical sensors, the electrical contacts 1110a on the detection layer 1110 are exposed to facilitate insertion into the meter.

The surface dimensions, for example, length, of the layer that can be brought into contact with the meter 1114 preferably are greater than those of the cover layer 1102, so that the electrical contacts, in the case of the electrochemical sensors printed on the layer that can be put in contact with the meter, are exposed for insertion into the meter. The opacity of the layer that can be brought into contact with the meter is not critical unless photometric detection is used. As stated above, an optional dust jacket layer 1123, as shown in Figure 28, can be interposed between the cover layer 1102 and the layer that can be contacted with the meter 1114 to restrict the flow of blood in the blood conveying layer 1108. The dust jacket layer can be prepared by means of a material that is initially in liquid form or in a form capable of penetrating the interstices of a mesh. This material is preferably an electrically insulating hydrophobic ink. This material is preferably applied by screen printing on a portion of the periphery of the blood-carrying layer (which is preferably in the form of a mesh), surrounding thereby and defining a convenient path for the blood sample to travel from the where it makes contact with the blood transport layer to the detection layer 1110. See U.S. Patent No. 5,628,890 for further discussion about the manner in which the dust jacket layer holds and fixes the mesh layer in place. The dust jacket layer 1123 and the blood transport layer 1108 are substantially coplanar. The term "coplanar" is used here, means that at least one surface of the two materials receives in the same plane. Substantially, coplanar placement of this layer is preferred because the transportation layer 1108 distributes blood in all directions. In order to limit the dispersion of blood in undesired areas of multiple layers, the jacket layer 1123 acts as a barrier to blood flow. The blood transporting layer 1108 adheres to the layer that can be contacted with the meter 1114 by embedding the edges of the blood carrying layer 1108 within the jacket layer 1123. Figure 28 illustrates the relationship between planes of the optional dust jacket layer 1123 and the blood-carrying layer 1108. As used herein, the term "substantially coplanar" includes both the situation in which at least one larger surface of the jacket layer 1123 and at least a larger surface of the blood carrying layer 1108 are in the same plane and the situation in which at least one same a larger surface of the jacket layer 11123 extends slightly beyond at least one larger surface of the transporting layer blood 1108. True coplanarity, that is, the previous situation, is difficult to achieve mainly due to manufacturing conditions. Substantial coplanarity, that is, the last situation, is more likely to be achieved under real manufacturing conditions. Figure 28 illustrates the most likely fabrication result, however, it is preferred that the jacket layer 1123 and the blood conveying layer 1108 approximate true coplanarity as much as possible, so that the volume of blood needed to be extracted Be as small as possible.

METHOD FOR PREPARING THE ELEMENT OF MULTIPLE LAYERS The multi-layer element is preferably produced in masses. However, the following method can be used for the manufacture of a single multi-layer element. The layer that can be brought into contact with the meter 1114 can be provided in the form of a sheet. In a typical construction, the layer that may be contacted with the meter 1114 may be a sheet of polyvinyl chloride. The detection layer 1110 may be printed on the screen on the layer that may be contacted with the meter 1114. The detection layer 1110 may be a biosensor of a type described in U.S. Patent No. 4,545,382, incorporated herein by reference. present by reference. In a preferred embodiment the electrodes of the detection layer 1110 contain a biologically active substance which reacts with glucose as preferably oxidized glucose or dehydrogenated glucose and an electrically conductive material, preferably carbon, which carries the electrical signal produced by the glucose reaction with the biologically active substance towards an electrical connector with the meter. The generation of the electrical signal can be aided by compounds known as mediators, which increase the electrical signals. (See Ferrocene Madiated Enzyme Electrode for Amperometric Determination of Glucose, Anal, Chem, 1984, 56, 667- 671. The electrical circuit is supplemented by at least some other electrically conductive material, preferably silver chloride, which is known as a reference electrode or counter electrode. The blood transporting layer 1108 is then placed in a position such that it can be in fluid communication with the detection layer 1110. The cover layer 1102 can then adhere to the blood transport layer by means of a fusion adhesive hot OPERATION Referring now to Figures 21a and 21b, which illustrate the components of the multilayer element in detail, and Figures 29a, 29b, 29c, ^ and 29d, illustrating how the multi-layer element works, with the In order to use the article of this invention to detect the presence or amount of analyte in a blood sample, the multi-layered element 1100 is placed between a lancet retainer 1124 and the tip assembly 1126 of the blood collection apparatus. The assembly. tip 1126 comprises a tip 1127 and a seal 1128. The opening 1104 in the cover layer 1102 and the opening 1116 in the layer that can be brought into contact with the meter 1114 are aligned with a lance 1130 of a puncture assembly 1131 The seal 1128 of the tip assembly 1126 of the blood collection apparatus is placed against the "S" skin. Figure 29a illustrates the apparatus before the application of the vacuum. Figure 29b illustrates the apparatus after vacuum application, after the skin is stretched and pulled to contact the cover layer 1102 of the multilayer element. The vacuum is applied for a period of time sufficient to cause blood to accumulate in the skin, which is pulled towards the tip 1127. The puncture assembly is then activated if the lancet 1130 passes through an opening 1132 in the lancet retainer 1124 and openings in the multiple layer element (shown in dashed lines in Figures 29a, 29b, 29c, and 29d and designated by reference numerals 1104 and 1116 in Figures 21a, and 21b). Then the lancet penetrates the skin, forming an opening in it. Figure 29c Then the lancet retracts, thereby forming an unobstructed opening in the skin. Blood "B", leaves the unobstructed opening in the skin aided by vacuum, and comes in contact with the layer carrying blood 1108 flows along the layer carrying blood, after which it reaches the layer of detection 1110. See Figure 29d. A chemical reaction occurs in the detection layer. The output of the chemical reaction can be read from the electrical contacts 1110a of the detection layer 1110. After the multi-layer element is filled, the vacuum is released and the skin moves away from the tip. In the case of an electrochemical sensor, the layer that can be contacted with the meter 1114 must physically contact the meter (not shown), in order to make the sensor, i.e., the detection layer 1110, make electrical contact with the meter, such as by inserting it into an electrical connector. The layer that can be brought into contact with the meter can also serve to physically align the multi-layered element with the meter in order to properly align the lancet with the opening 1126 in the layer that can be brought into contact with the meter. In the case of the reflectance strip, the layer that can be brought into contact with the meter should be mounted on the meter to allow alignment of the light source and meter detector with the reflectance strip, as well as allow alignment Physics of the multi-layered element with the meter, so that the lancet is properly aligned with the opening 1116 in the layer that can be brought into contact with the meter. Although not preferred, it is also possible to provide a workable multi-layered element that dispenses with the blood transport layer. In order to eliminate the blood transport layer, the layer that can be brought into contact with the meter and the cover layer can be arranged in such a way that the blood can flow between them towards the detection layer by means of action capillary. A modality that involves the flow by means of capillary action, the larger surface of the layer that can be brought into contact with the meter that faces the larger surface of the cover layer and the larger surface of the cover layer that is facing the larger surface of the layer that can be brought into contact with the meter should be hydrophilic in nature. At least one of the above major surfaces, and preferably both of the above major surfaces, may be made of hydrophilic material or may be coated, with hydrophilic material, such as, for example, a surfactant. The hydrophilicity of these layers will cause the extracted blood to flow in the space between the layer that can be contacted with the meter and the cover layer towards the detection layer. In this way, it is clear that the blood transport layer can be removed. In this embodiment, the layer that can be brought into contact with the meter must have sufficient length so that the capillary channel can be formed between the layer that can be brought into contact with the meter and the cover layer. Thus, if the cover layer is of such length that it requires an opening through which the lancet can pass, it is preferred that the layer that can be brought into contact with the meter also has a length such as to require an opening. through which the lancet can pass. The capillary channel may, in effect, be formed by means of the jacket layer, which causes a capillarity width space to be formed between the layer that can be brought into contact with the meter and the cover layer. Using the multi-layered element of this invention, blood collection can be carried out in a very efficient manner. By improving the efficiency of the collection, the period of time required to obtain blood for its analytical purposes is reduced. Figures 5 through 10, and 43 through 46, illustrate several alternative embodiments of the apparatus of this invention. In Figure 5, the blood extraction device 100 comprises a housing 102. The housing 102 is separable into two portions, a receiving portion 102a and a projection portion 102b. A gasket 104 is provided to seal the portions 102a and 102b of the housing 102 and to aid separation in the receiving portion 102a of the projection portion 102b. The receiving portion 102a forms a tight fit with the projection portion 102b by means of friction. The projection elements 102c and 102d are used to guide the projection portion 102b toward the receiving portion. 102a. Arranged within the housing 102 is a vacuum pump (not shown), a puncture assembly 108, a battery (not shown), and electronic (not shown). A switch 109 is provided to activate the electronics. The vacuum pump is connected to the puncture assembly 108 by an evacuation tube (not shown). A check valve (not shown) is placed between the vacuum pump and the puncture assembly 108. During the sample collection process, the receiving portion 102a and the projection portion 102b are hermetically adjusted to each other. The area of the receiving portion 102a of the housing 102 of the device 100 that is in contact with the skin is equipped with a seal 110. The seal 110 surrounds an opening 112 in the receiving portion 102a. The opening 102 in the receiving portion 102a allows communication between the surface of the skin and a blood collection chamber adjacent the glucose detector 114, shown here in the form of a strip. When in use, the device 100 is positioned so that the puncture assembly is placed over the region, on the surface of the skin from which the sample is to be obtained. In order to obtain the blood sample, the receiving portion 102a of the housing 102 of the device 100 is placed against the skin, whereby the seal 110 allows a satisfactory vacuum to be effected. The switch 109 is activated, typically by pressing it, whereby the electronics are activated, which start the vacuum pump. The vacuum pump then provides a suction action. The suction action of the vacuum pump causes the skin circumscribed by the seal 110 to fill with blood. The accumulation of blood in the skin is accompanied by a stretching and lifting the skin to the opening 112. After a suitable period of time, which is typically pre-set by the programmer of electronic, assembly puncture 108 fires , thereby causing the lancet 116 to penetrate the skin that has been raised towards the opening 112 and which is filled with blood. The lancet 116 preferably triggers so automatically, by a solenoid valve (not shown) causes a vacuum powered piston (not shown) to trigger the lancet 116. The remaining steps of the process in connection with collecting a sample of blood are substantially similar to the steps described in the embodiment shown 1, 2, 3 and 4. In the embodiment shown in Figure 5, the glucose detector 114 is inserted into a slot 118 in the projection portion 102b of the housing 102. The receiving portion 102a of the housing 102 causes the glucose detector 114 to move to its proper position for testing. The results obtained from the glucose detector 114 can be displayed on a screen 120, typically a conventional liquid crystal digital display. Receiving portion 102a is separated from projection portion 102b when lancet 116 or glucose detector 114 is being replaced. The receiving portion 102a is hermetically adjusted to the projection portion 102b during the process of obtaining a blood sample. The relative positions of the vacuum pump, the battery, the electronics, the evacuation tube, the check valve, the solenoid valves, and the vacuum activated piston are substantially similar to the relative positions of these components as described in FIG. embodiments shown in Figures 1 and 2. In Figure 6, the blood extraction device 200, comprises a housing 202. The housing 202 comprises a dportion 202a which is attached to the remaining portion 202b of the housing 202 by a joint 206. A package 207 is provided to seal the housing 202 when the dportion 202a is closed. The dportion 202a can be pivotally closed around the link 206. When the dportion 202a is closed, the convex portion 202c of the door portion 202a fits snugly in the concave portion 202b of the remaining portion 202b of the housing 202. The remaining edges of the door portion 202a are hermetically adjusted against, the remaining edges of the remaining portion 202b of the housing 202. Arranged within the housing 202 is a vacuum pump (not shown), a puncture assembly 208, a battery (not shown), and electronics (not shown). A switch (not shown) is provided to activate the electronics. The vacuum pump is connected to the puncture assembly 208 by an evacuation tube (not shown). A check valve (not shown) is placed between the vacuum pump and the puncture assembly 208.

During the sample collection process, the door portion 202a is closed. The area of the door portion 202a of the housing 202 of the device 200 that will be in contact with the skin is equipped with a seal (not shown). The seal surrounds an opening 212 in the door portion 202a. The opening 212 in the door portion 202a allows communication between the surface of the skin and the blood collection chamber adjacent to the glucose detector 214, shown here in the form of a strip. When in use, the device 200 is positioned so that the puncture assembly 208 is placed over the region on the surface of the skin from which the sample is to be obtained. In order to obtain the blood sample, the door portion 202a of the housing 202 of the device 200 is placed against the skin, whereby the seal allows a satisfactory vacuum to be effected. The switch is activated, typically by pressing it, activating by this the electronics, which start the vacuum pump. The vacuum pump then provides a suction action. The suction action of the vacuum pump causes the skin circumscribed by the seal to fill with blood. The accumulation of the skin with blood is accompanied by a stretching and lifting of the skin towards the opening 212. After a suitable period of time, which is typically set in advance by the electronic programmer, the puncture assembly 208 is it triggers, thereby causing the lancet 216 to penetrate the skin which is raised towards the opening 212 and which is filled with blood. The lancet 216 is preferably triggered automatically by a solenoid valve (not shown) which causes a vacuum-activated piston (not shown) to fire the lancet 216. The remaining steps of the process in relation to the collection of a blood sample, they are substantially similar to the steps described in the embodiment shown in Figures 1, 2, 3 and 4. In the embodiment shown in Figure 6, the glucose detector 214 is inserted into the slots 218a and 218b of the housing 202. The results obtained from the glucose detector 214 can be displayed on the screen 220, typically a conventional liquid crystal digital display. The door portion 202a opens when the lancet 216 or the glucose detector 214 is being replaced. The door portion 202a is closed during the process of obtaining a blood sample. The relative positions of the vacuum pump, battery, electronics, switch, evacuation tube, check valve, seal, solenoid valves, and vacuum activated piston are substantially similar to the relative positions of these components as described in the embodiments shown in Figures 1 and 2. In Figure 7 the blood device 300 comprises a housing 302, the housing 302 comprises a door portion 302a which joins the remaining portion 302b of the housing 302, by a hinge 306. A package 307 is provided to seal the housing 302 when the door portion 302a is closed. The door portion 302a can be pivotally closed around the joint 306. When the door portion 302a closes, the convex portion 302c of the door portion 302a is precisely adjusted in the concave portion 302d of the remaining portion 302b of the housing 302 The remaining edges of the door portion 302a are hermetically adjusted against the remaining edges of the remaining portion 302b of the housing 302. Arranged within the housing 302 is the vacuum pump (not shown) a puncture assembly 308, a battery (not shown). shown), and electronics (not shown). A switch (not shown) is provided to activate the electronics. The vacuum pump is connected to the puncture assembly 308 by an evacuation tube (not shown). A check valve (not shown) is placed between the vacuum pump and the puncture assembly 308. During the process to obtain the sample, the door portion 302a is closed. The area of the door portion 302a of the housing 302 of the device 300 to be brought into contact with the skin is equipped with a seal (not shown). The seal surrounds an opening 312 of the door portion 302a. The opening 312 in the door portion 302 allows communication between the surface of the skin and a blood collection chamber adjacent to the glucose detector 314, shown here in the form of a strip. When in use, the device 300 is positioned so that the puncture assembly 308 is placed over the region on the surface of the skin from which the sample is to be obtained. In order to obtain the blood sample, the door portion 302a of the housing 302 of the device 300 is placed against the skin, whereby the seal allows a satisfactory vacuum to be made. The switch is activated, typically by pressing it, activating by this the electronics, which start the vacuum pump. The vacuum pump then provides a suction action. The suction action of the vacuum pump causes the skin circumscribed by the seal to become congested with blood. Congestion of the skin with blood is accompanied by a stretching and lifting of the skin towards the opening 312. After a suitable period of time, which is typically previously set by the electronic programmer, the puncture assembly 308, is triggered, thereby causing the lancet 316 to penetrate the skin that has been raised into the opening 312 and which is congested with blood. The lancet 316 is preferably triggered automatically, by a solenoid valve (not shown) that causes a vacuum-activated piston (not shown) to fire the lancet 316. The remaining steps of the process in relation to the collection of a blood sample are substantially similar to the steps described in the embodiment shown in Figures 1, 2, 3 and 4. In the embodiment shown in Figure 7, the glucose detector 314 is inserted into a slot 318 of the housing 302. The results obtained from the detector of glucose 314 can be displayed on screen 320, typically a conventional liquid crystal display. In Figure 7, connections 322 of the electronics are shown. The door portion 302a opens when the lancet 316 or the glucose detector 314 is being replaced. The door portion 302a is closed during the process of obtaining a blood sample. The relative positions of the vacuum pump, battery, electronics, switch, evacuation tube, check valve, seal, solenoid valves, and vacuum activated piston are substantially similar to the relative positions of these components as described in the modalities shown in Figures 1 and 2.In Figure 8, a blood collection device 400 comprises a housing 402. The housing 402 comprises a door portion 402a that is attached to the remaining portion 402b of the housing 402 by a hinge 406. A package 407 is provided to seal the housing 402, when the door portion 402a is closed. The door portion 402a can be pivotally closed around the hinge 406. When the door portion 402a is closed, the convex portions 402c and 402d, of the door portion 402a, fit precisely in the concave portions 402e and 402f , respectively, of the remaining portion 402b of the housing 402. The remaining edges of the door portion 402a are hermetically adjusted against the remaining edges of the door portion 402b of the housing 402. Arranged within the housing 402 is a vacuum pump ( not shown), a puncture assembly 408, a battery (not shown), and electronics (not shown). A 409 switch is provided to activate the electronics. The vacuum pump is connected to the lancing assembly 408 by an evacuation tube (not shown), a check valve (not shown) is placed between the vacuum pump and the lancing assembly 408. During the process of obtaining shows, the door portion 402a is closed. The area of the door portion 402a of the housing 402 of the device 400 that will be in contact with the skin is equipped with a seal (not shown). The seal surrounds an opening 412 in the door portion 402a. The opening 412 in the door portion 402a allows communication between the surface of the skin and a blood collection chamber adjacent the glucose detector 414, shown here in the form of a strip. When in use, the device 400 is positioned so that the puncture assembly 408 is placed over the region on the surface of the skin from which the sample is to be obtained. In order to obtain the blood sample, the door portion 402a of the housing 402 of the device 400 is placed against the skin, whereby the seal allows a satisfactory vacuum to be effected. The switch 409 is activated, typically by depressing it, thereby activating the electronics, which start the vacuum pump. The vacuum pump then provides a suction action. The suction action of the vacuum pump causes the skin circumscribed by the seal to become congested with blood. Congestion of the skin with blood is accompanied by a stretching and lifting of the skin towards the opening 412. After a suitable period of time, which is typically previously set by the electronic programmer, the puncture assembly 408, is It triggers, thereby causing the lancet 416 to penetrate the skin that is elevated towards the opening 412 and which is congested with blood. The lancet 416 is preferably automatically triggered by a solenoid valve (not shown) which causes a vacuum-activated piston (not shown) to fire the lancet 416. The remaining steps of the process in relation to the collection of a blood sample are substantially similar to the steps described in the embodiment shown in Figures 1, 2, 3 and 4. In the embodiment shown in Figure 8, the glucose detector 414 is inserted into a slot 418 of the housing 402. In this embodiment, it is shown that the glucose detector 14 can be rotated 90 ° between two positions to simplify insertion and replacement thereof. The results obtained from the glucose detector 414 can be displayed on the screen 420, typically a conventional liquid crystal digital display. The door portion 402a opens when the lancet 416 of the glucose sensor 414 is being replaced. The door portion 402a is closed during the process of obtaining a blood sample. Relative positions of the vacuum pump, the battery, electronics, the switch, the evacuation tube, the check valve, the seal, the solenoid valves, and the vacuum-activated piston are substantially similar to the relative positions of these components as described in the embodiments shown in Figures 1 and 2. In FIG. Figure 9, the blood extraction device 500 comprises a housing 502. The housing 502 comprises a cover portion 502a which is joined to the remaining portion 502b of the housing 502 by a hinge 506. A package 507 is provided to seal the housing 502 , when the door portion 502 is closed. The cover portion 502a can be pivotally closed around the joint 506. When the cover portion 502a is closed, the edges 502c of the cover portion 502a are tightly against the edges 502d of the remaining portion 502b of the housing 502. Disposed within the housing 502 are a vacuum pump (not shown), a puncture assembly 508, a battery (not shown), and electronic (not shown). A switch (not shown) is provided to activate the electronics.

The vacuum pump is connected to the puncture assembly 508 by an evacuation tube (not shown), a verification valve (not shown) is placed between the vacuum pump and the puncture assembly 508. During the process of obtaining the sample , the cover portion 502a. The cover portion 502a of the housing 502 of the device 500 to be brought into contact with the skin is equipped with a seal 511. The seal 511 surrounds an opening 512 of the cover portion 502a. The opening 512 in the cover portion 502 allows communication between the surface of the skin and a blood collection chamber adjacent to the glucose detector 514, shown here in the form of a strip. When in use, the device 500 is positioned so that the puncture assembly 508 is placed over the region on the surface of the skin from which the sample is to be obtained. In order to obtain the blood sample, the cover portion 502a of the housing 502 of the device 500 is placed against the skin, whereby the seal allows a satisfactory vacuum to be effected. The switch is activated, typically by pressing it, activating by this the electronics, which start the vacuum pump. The vacuum pump then provides a suction action. The suction action of the vacuum pump causes the skin circumscribed by the seal to become congested with blood. Congestion of the skin with blood is accompanied by a stretching and lifting of the skin towards the opening 512. After a suitable period of time, which is typically previously set by the electronic programmer, the puncture assembly 508, it is triggered, thereby causing the lancet 516 to penetrate the skin that has been raised into the opening 512 and which is congested with blood. The lancet 516 is preferably triggered automatically, by a solenoid valve (not shown) that causes the vacuum-activated piston (not shown) to fire the lancet 516. The remaining steps of the process in relation to the collection of a blood sample are substantially similar to the steps described in the embodiment shown in Figures 1, 2, 3 and 4. In the embodiment shown in Figure 9, the glucose detector 514 is inserted 518 of the housing 502. The results obtained from the glucose detector 514 are they can display on screen 520, typically a conventional liquid crystal digital display. The cover portion 502a opens when the lancet 516 or the glucose sensor 514 is being replaced. The cover portion 502a is closed during the process of obtaining a blood sample. The relative positions of the vacuum pump, the battery, the electronics, the switch, the evacuation tube, the check valve, the solenoid valves, and the vacuum-activated piston are substantially similar to the relative positions of these components as shown in FIG. described in the embodiments shown in Figures 1 and 2. In Figure 10, the blood extraction device 600 comprises a housing 602. The housing 602 comprises a cover portion 602a which is joined to the remaining portion 602b of the housing 602 by a hinge 606. A package 607 is provided to seal the housing 602, when the cover portion 602a is closed. The cover portion 602a can be pivotally closed around the articulation 606. When the cover portion 602a is closed, the edges 602c of the cover portion 602a are tight against the edges 602d of the remaining portion 602b of the housing 602. Disposed within the housing 602 are a vacuum pump (not shown), a puncture assembly 608, a battery (not shown), and electronics (not shown). A switch (not shown) is provided to activate the electronics. The vacuum pump is connected to the puncture assembly 608 by an evacuation tube (not shown). A check valve (not shown) is placed between the vacuum pump and the puncture assembly 608. During the process of obtaining the sample, the cover portion 602a. The cover portion 602a of the housing 602 of the device 600 to be brought into contact with the skin is equipped with a seal 611. The seal 611 surrounds an opening 612 of the cover portion 602a. The opening 612 in the cover portion 602a allows communication between the surface of the skin and a blood collection chamber adjacent the glucose detector 614, shown here in the form of a strip. When in use, the device 600 is positioned so that the puncture assembly 608 is placed over the region on the surface of the skin from which the sample is to be obtained. In order to obtain the blood sample, the cover portion 602a of the housing 602 of the device 600 is placed against the skin, whereby the seal allows a satisfactory vacuum to be effected. The switch is activated, typically by pressing it, activating by this the electronics, which start the vacuum pump. The vacuum pump then provides a suction action. The suction action of the vacuum pump causes the skin circumscribed by the seal to become congested with blood. Congestion of the skin with blood is accompanied by a stretching and lifting of the skin towards the opening 612. After a suitable period of time, which is typically previously set by the electronic programmer, the puncture assembly 608, is triggered, thereby causing the lancet 616 to penetrate the skin that has been raised to the opening 612 that is congested with blood. The lancet 616 is preferably triggered automatically, by a solenoid valve (not shown) that causes the vacuum-activated piston (not shown) to fire the lancet 616. The remaining steps of the process in relation to the collection of a blood sample are substantially similar to the steps described in the embodiment shown in Figures 1, 2, 3 and 4. In the embodiment shown in Figure 10, the glucose detector 614 is inserted into a slot 618 of the housing 602. The results obtained from the detector of glucose 616 can be displayed on screen 620, typically a conventional liquid crystal digital display. The cover portion 602a opens when the lancet 616 or the glucose detector 614 is being replaced. The cover portion 602a is closed during the process of obtaining a blood sample. The relative positions of the vacuum pump, the battery, the electronics, the switch, the evacuation tube, the check valve, the solenoid valves, and the vacuum-activated piston are substantially similar to the relative positions of these components as shown in FIG. described in the embodiments shown in Figures 1 and 2. Referring now to Figures 43a to 43c, which represent another embodiment of the present invention, the blood collection device 700 comprises a housing 702 having an inner cover portion 702a (shown in the open position in Figure 43a and in the closed position in Figure 43b) a door portion 702b (shown in the open position in Figures 43a and 43b, and in the closed position in Figure 43c), and a body portion 702c. The cover portion 702a can be advantageously positioned, via the projection 703, on top of the body portion 702c by a joint in the form of a link 705. Alternatively, the inner cover portion 70a can be attached to the body portion. 702b by a friction joint, a stop (not shown), or a combination of a hinge 705, a friction joint, and a stop. When a hinge 705 is used, it may optionally be spring biased to retain the inner cover portion 702a in the open or closed position. A stop (not shown) can be provided on the inner cover portion 702a to engage with a protrusion (not shown) on the projection 703, or vice versa, to maintain the inner cover portion 702a in the open or closed position when desired. Although a hinge 705 is provided in the embodiment shown in Figures 43a through 43c, any other joint or combination of joints that allow the inner cover portion 702a to be attached to the body portion 702c and alternate between an open position and closed is acceptable. The door portion 702b is attached to the body portion 702c of the housing 702 by a link 706. Alternatively, the door portion 702b can be attached to the body portion 702c by friction attachment, a stop, or any combination of a joint 706, friction joint, and stop. When a joint 706 is used, it may optionally be spring-biased to obtain the port portion 702b in the open or closed position. A stop (not shown) can be provided in the door portion 702b to engage with a protrusion (not shown) in the body portion 702c, or vice versa, to hold the door portion 702b in the open or closed position when desired . Although a hinge 706 is provided in the embodiment shown in Figures 43a through 43c, any other joint or combination of joints that allows the door portion 702b to attach to the body portion 702c and alternate between an open and closed position is acceptable . A packing or other seal arrangement 707 is provided to seal the housing 702 when the cover portion 702a and the door portion 702b are closed. Additionally, a bolt mechanism (not shown) can be provided to prevent accidental opening of the door portion 702b when the device 700 is in use. Typically, the bolt mechanism would provide locking engagement of the door portion 702b with the body portion 702c. Arranged within the housing 702 is a vacuum pump (not shown), a lancet assembly 708 which generally comprises a plastic molded part 730 to which the lancet 716 is attached, a puncture assembly (not shown) in which the Lancet assembly 708 is inserted, a battery (not shown), and electronics (not shown) for the purposes described hereinafter. A switch 709 is provided to activate the electronics, which can take the form shown in Figure 3. The vacuum pump is communicated by an evacuation tube (not shown) with the volume in <missed by the door portion 702b when the door portion 702b is in the closed position. Optionally, a check valve (not shown) can be placed in the evacuation tube between the vacuum pump and the volume enclosed by the door portion 702b when the door portion 702b is in the closed position. During the process of obtaining the sample, the inside portion of the cover 702a and the door portion 702b close together with the body portion 702c to form a seal. The seal should be sufficiently watertight so that sufficient vacuum can be obtained to remove air from the volume enclosed by the door portion 702b, when the door portion 702b is in the closed position. When the inner cover portion 702a is closed, the lancet 716 is completely enclosed within the cover portion 702a, thereby preventing the individual being tested from accidentally coming into contact with the lancet 716. The cover portion interior 702a, contains an opening 713, Figure 43b, which allows the lancet 716 to extend therethrough and contact the skin as described hereinafter. The opening 703 can be round, oval, rectangular or any other shape. The inner cover portion 702a may also contain a shoulder portion (not shown) in the interior of the cover portion 702a surrounding all or a portion of the opening 713. When included preferably the shoulder portion stops the lancet assembly. 708 so that it does not extend beyond the shoulder portion and prevent the lancet 716 from extending more than what is desired inside the skin. The preferred depth of puncture typically varies from about 0.5mm to about 3mm inside the skin. The area of the door portion 702b of the housing 705 that is in contact with the skin is equipped with a seal 711, Figure 43c. The seal 711 surrounds an opening 712 in the door portion 702b that is aligned with the opening 713 in the inner cover portion 702a when both the inner cover portion 702a and the door portion 702b are in the closed position. The opening 712 may be round, oval, rectangular, or otherwise. The opening 712 in the door portion 702b, allows communication between the surface of the skin and the blood collection chamber adjacent to a fluid collector, shown here in the form of a glucose detector 714, Figure 43b, which may have the shape of a strip. Other types of fluid collectors can also be used, and those skilled in the art will recognize that the present embodiment can easily be modified to include more than one fluid collector. Preferably, the glucose detector 714 used in the embodiment shown in Figures 43a through 43c, contains an opening 715 about half the glucose sensor 714 for the lancet 716 to pass through. The opening 715 is preferably in alignment with the openings 712 and 713 and the lancet 716. The opening 715 can be covered with a mesh. When in use, the device 700 is positioned so that the puncture assembly is placed over the region on the surface of the skin from which the fluid sample is to be obtained so that the puncture assembly is approximately perpendicular to the skin. the surface of the skin. To obtain the blood sample, the door portion 702b of the housing 702 is placed against the skin, whereby the seal 711 surrounding the opening 712 allows a satisfactory vacuum to be effected. The switch 709 is activated, typically by pressing it, activating by this the electronics, described in Figure 3 and discussed above, which start the vacuum pump. The action of the vacuum pump extracts air from the volume closed by the door portion 702b when the position of the door 702b is in the closed position and cause the skin circumscribed by the seal 711 to pull toward the opening 712. This gives as result that the skin is congested with blood. Congestion of the skin with blood is accompanied by the stretching and lifting of the skin towards the opening 712 in the door portion 702b. After an adequate period of time, which is typically previously established by the programmed electronics, the puncture assembly is triggered, thereby causing the lancet 716 to penetrate the skin that has been pulled toward the opening 712 of the door portion 702b. The lance 716 is preferably triggered automatically by the activation of a solenoid valve (not shown) which causes a vacuum activated piston (not shown) to fire the lancet 716. The remaining steps of the process in relation to the collection of a sample of blood, are substantially similar to the steps described when using the embodiment shown in Figure 1 through 4. In the embodiment shown in Figures 43a through 43c, the glucose detector 714 is inserted into a slot 718. in projection 703 of housing 702. Glucose detector 714 contains one or more electrical contacts (not shown) at the ends inserted into slot 718 that engage with one or more electrical contacts (not shown) placed within slot 718 In the embodiment shown in Figures 43a to 43c, the slot 718 can be designed so that the glucose detector 714 is placed inside the slot 718 at an angle advantageously per limit the easiest, and cleanest, removal of the 714 glucose detector at the end of the test. Alternatively the slot 718 may be designed so that the glucose detector 714 is positioned in the slot 718 substantially parallel to the upper surface of the inner cover portion 702a when the inner cover portion 702a is in the closed position. The alignment channels 719a and 719b on either side of the exterior of the inner cover portion 702a can be provided to align the glucose detector 714 so that the glucose detector 714 is properly aligned with the lance 716. of alignment (not shown) within the interior of the door portion 702b may also be provided to assist in the alignment of the glucose detector 714 on the lance 716 when the door portion 702b is closed. Both the inner cover portion 702a and the door portion 702b are closed during the process of obtaining a blood sample.

After the lancet 716 pierces the skin and is retracted, the blood is drawn, under vacuum, to and over the glucose detector 714. When a sufficient amount of blood has been collected, the glucose detector 714 is generated a signal that results in the deactivation of the vacuum pump and the vacuum is released by, for example, an electronically controlled valve. Alternatively, the vacuum pump can be stopped after a pre-set time interval. The blood collection device 700 can then be removed from the individual's skin. After that, the glucose detector 714 generates a signal, as described above, which indicates the glucose level, this signal is transmitted via electric circuits to the electronics housed in the blood collection device 700. The signal is processed by those electronic, in the manner described above, and the results obtained from the glucose detector 714 can be displayed on a display 720, typically a conventional liquid crystal digital display. Other ways of deployment can also be used. After completing the measurement, the door portion 702b can be opened and the glucose detector 714 can be replaced. When it is desired to replace the lancet 716, both the door portion 702b and the interior cover 702a are opened as described above. The lancet 716 and the glucose detector 714 can be replaced immediately after use, immediately before use, or can be replaced at any other time. Referring now to Figures 44a and 44b, which represent another embodiment of the present invention, the blood extraction device 800 comprises a housing 802. The housing 802 includes a door portion 802a (shown in the open position in Figure 44a). , and in the closed position in Figure 44b) which is attached to the body portion 802b of the housing 802 by a joint in the form of a hinge 806. Alternatively, the door portion 802a can be attached to the body portion 802b by friction connection, a stop (not shown), or any combination of a hinge 806, a friction joint, and a stop. When an articulation 806 is used, it may optionally be spring-biased to retain the door portion 802a in the open or closed position. A stop (not shown) can be provided in the door portion 802a to engage a protrusion (not shown) in the body portion 802b, or vice versa, to hold the door portion 802a in the open or closed position when desired . Although an articulation 806 is provided in the embodiment shown in Figures 44a and 44b, any other joint or combination of joints that allow the door portion 802a to attach to the body portion 802b and alternate between open and closed positions is acceptable. The link 806 can be located in the body portion 802b as shown in Figures 44a and 44b or alternatively located on one side of the body portion 802b. A package or some other seal arrangement 807 is provided to seal the housing 802 when the door portion 802a is closed. Additionally, it may include a latch mechanism to prevent accidental opening of the door portion 802a when the blood collection device 800 is in use. Typically, the latch mechanism will provide latching engagement of the door portion 802a, with the body portion 802b. Arranged within the housing 802 is a vacuum pump (not shown), a lancet assembly 808 which generally comprises a plastic molded part 830 to which the lancet 816 is attached, a lancet assembly (not shown) in which the lancet assembly 808 is inserted, a battery (not shown), and electronics (not shown). A switch 809, Figure 44b, is provided to activate the electronics, which can take the form shown in Figure 3. The vacuum pump communicates via an evacuation tube (not shown) with the volume in <wrong in the door portion 802a when the door portion 702a is in the closed position. Optionally, a check valve (not shown) can be placed in the evacuation tube between the vacuum pump and the volume enclosed by the door portion 802a when the door portion 802a is in the closed position. During the sample collection process, the door portion 802a is closed to form a seal. The seal should be sufficiently watertight so that sufficient vacuum can be obtained to remove air from the volume enclosed by the door portion 802a when the door portion 802a is in the closed position. The area of the door portion 802a of the housing 802 that is in contact with the skin is equipped with a seal (not shown). The seal 811 surrounds an opening 812 (shown in dotted lines in Figure 44b) in the door portion 802a. The opening 812 can be round, oval, rectangular, or in any other way. The opening 812 in the door portion 802a allows communication between the surface of the skin and the blood collection chamber adjacent to a fluid collector, shown here in the form of a glucose detector 814, which can take the shape of a strip. Other types of fluid collectors can also be used, and those skilled in the art will recognize that the present embodiment can easily be modified to include more than one fluid collector. Preferably, the glucose detector 814 used in the embodiment shown in Figures 44a and 44b, contains an opening 815 in about half of the glucose detector 814 for the lancet 816 to pass through. The opening 815 is preferably in alignment with the openings 812 and the lancet 816. The opening 815 can be covered with a mesh. When in use, the blood collection device 800 is positioned so that the puncture assembly is placed over the region on the surface of the skin from which the blood sample is to be obtained so that the puncture assembly be approximately perpendicular to the surface of the skin. In order to obtain the blood sample, the door portion 802a of the housing 802 is placed against the skin, whereby the seal surrounding the opening 812 allows a satisfactory vacuum to be effected. The switch 809 is activated, typically by pressing it, activating by this the electronics, described in Figure 3 and discussed above, which start the vacuum pump. The vacuum pump then provides a suction action. The action of the vacuum pump extracts air from the volume enclosed by the door portion 802a when the door portion 802a is in the closed position and causes the skin circumscribed by the seal to pull toward the opening 812. This results in the skin is congested with blood. Congestion of the skin with blood is accompanied by the stretching and lifting of the skin towards the opening 812 in the door portion 802a. After a suitable period of time, which is typically established by the programmed electronics, the puncture assembly is triggered, thereby causing the lancet 816 to penetrate the skin that has been pulled toward the opening 812 of the door portion 802a and It is congested with blood. The lancet 816 is preferably triggered automatically by the activation of a solenoid valve (not shown) that causes a vacuum-activated piston (not shown) to fire the lancet 816. The remaining steps of the process in relation to the collection of a sample of blood, are substantially similar to the steps described when using the embodiment shown in Figure 1 through 4. In the embodiment shown in Figures 44a and 44b, the glucose detector 814 is inserted into a slot 818 of the port portion 802a of housing 802. Alignment channels 819a and 819b, preferably, C-shaped, along one of the two sides of the slot 818 can be used to align the glucose detector 814 so that the glucose detector 814 is properly aligned with the lancet 816. Preferably, the alignment channels 819a and 819b only cover a small portion of each side of the glucose detector 814 to minimize the chance of blood remaining in the slot 818 and in the alignment channels 819a and 819b when the glucose detection 814 is removed. In a preferred embodiment, some portion of the glucose detector 814 should extend beyond the top of the door portion 802a to ensure easy removal of the glucose detector 814. In the embodiment shown in Figures 44a and 44b, the glucose detector 814 contains one or more electrical contacts (not shown) at the end opposite the end inserted in the slot 818 that engages one or more electrical contacts (not shown) positioned within a slot to 821 in the body portion 802b. The end of the glucose detector 814 with the electrical contacts is inserted into the groove 821 in the body portion 802b by the movement of the door portion 802a when the door portion 802a is closed. Alternatively, the blood collection device 800 may be designed so that the end of the glucose detector 814 containing one or more electrical contacts is inserted into the slot 818 to engage with one or more electrical contacts placed within the slot 818. and the end of the glucose detector 814 opposite the end containing the electrical contacts is inserted into the slot 821 by the movement of the door portion 802a when the door portion 802a is closed. The alignment channels 819a and 819b preferably can also stop the lancet assembly 808 from extending beyond the alignment channels 819a and 819b and prevent the lancet 816 from extending more than desired inside the skin. The preferred puncture depth typically varies from about 0.5mm to about 3mm inside the skin. The door portion 802a is closed during the process of obtaining a blood sample. After the lancet 816 pierces the skin and is retracted, the blood is drawn, under the aid of the vacuum, into and onto the glucose detector 814. When a sufficient amount of blood has been collected, the glucose detector 814 generates a signal that results in the deactivation of the vacuum pump and the vacuum is released by, for example, an electronically controlled valve. Alternatively, the vacuum pump can be stopped after a pre-set time interval. The blood collection device 800 can then be removed from the skin of the individual. After that, the glucose detector 814 generates a signal, as described above, which indicates the glucose level, this signal is transmitted via an electrical circuit to the electronics housed in the blood collection device 800. The signal is processed by those electronics, in the manner described above, and the results obtained from the glucose detector 814 can be displayed on a display 820, typically a conventional liquid crystal display. Other ways of deployment can also be used. After completing the measurement, the door portion 802a can be opened and the glucose detector 814 and the lancet 816 can be replaced. The lancet 816 and the glucose detector 814 can be replaced immediately after use, immediately before use, or can be replaced at any other time. Referring now to Figures 45a through 45e, which represent another embodiment of the present invention, the blood collection device 900 comprises a housing 902 having a door portion 902a. (shown in the open position in Figure 45a, in a partially closed position in Figure 45b, and in the closed position in Figures 45c to 45e) which is attached to the body portion 902b of the housing 902 by a shaped connection of a joint 906. Alternatively, the door portion 902a can be attached to the body portion 902b by friction joining, a stop (not shown), or any combination of a joint 906, a friction joint, and a stop. When a joint 906 is used, it may optionally be spring-biased to retain the door portion 902a in the open or closed position. A stop (not shown) can be provided in the door portion 902a to engage with a protrusion (not shown) in the body portion 902b, or vice versa, to hold the door portion 902a in the open or closed position when desired . Although a hinge 906 is provided in the embodiment shown in Figures 45a through 45e, any other joint or combination of joints that allow the door portion 902a to be attached to the body portion 902b and alternating between open and closed positions is acceptable. A package or some other seal arrangement (not shown) is provided to seal the housing 902 when the door portion 902a is closed. Additionally, it may include a bolt mechanism to prevent accidental opening of the door portion 902a when the blood collection device 900 is in use. Typically, the bolt mechanism will provide locking engagement of the door portion 902a, with the body portion 902b. Arranged within the housing 902 is a vacuum pump (not shown), a lancet assembly 908 which generally comprises a plastic molded part 930 to which the lancet 916 is attached, a puncture assembly (not shown) in which the lancet assembly 908 is inserted, a battery (not shown), and electronics (not shown) for the purposes described hereinafter. A switch 909 is provided to activate the electronics, which can take the form shown in Figure 3. The vacuum pump is communicated by an evacuation tube (not shown) with the volume in < missed by the door portion 902a when the door portion 902a is in the closed position. Optionally, a check valve (not shown) can be placed in the evacuation tube between the vacuum pump and the volume enclosed by the door portion 902a when the door portion 902a is in the closed position. During the sample collection process, the door portion 902a is closed to form a seal. The seal should be sufficiently watertight so that sufficient vacuum can be obtained to remove air from the volume enclosed by the door portion 902a when the door portion 902a is in the closed position. The area of the door portion 902a of the housing 902 that is in contact with the skin is equipped with a seal 910, Figure 45b. The seal 910 surrounds an opening 912 in the door portion 902a. The opening 912 can be round, oval, rectangular, or in any other way. The opening 912 in the door portion 902a allows communication between the surface of the skin and the blood collection chamber adjacent to a fluid collector, shown here in the form of a glucose detector 914, which can take the shape of a strip. Other types of fluid collectors can also be used, and those skilled in the art will recognize that the present embodiment can easily be modified to include more than one fluid collector. Preferably, the glucose detector 914 used in the embodiment shown in Figures 45a through 45e contains a semicircular notch (not shown) in the region of the glucose detector 914 that contacts the blood. The semicircular notch can be covered with a mesh. When in use, the blood collection device 900 is positioned so that the puncture assembly is placed over the region on the surface of skin 924, Figure 45c, from which the fluid sample is to be obtained so that the assembly of The puncture is approximately perpendicular to the surface of the skin 924. In order to obtain the blood sample, the door portion 902a of the housing 902 is placed against the skin 924, whereby the seal 910 surrounding the opening 912 allows a satisfactory vacuum is made. The switch 909 is activated, typically by depressing it, thereby activating the electronics, described in Figure 3 as discussed above, which start the vacuum pump. The action of the vacuum pump extracts air from the volume enclosed by the door portion 902a when the door portion 902a is in the closed position and causes the skin circumscribed by the seal 910 to pull toward the opening 912.

This results in the skin becoming congested with blood. Congestion of the skin with blood is accompanied by the stretching and lifting of the skin towards the opening 912 in the door portion 902 a, as shown in Figures 45c to 45e. After a suitable period of time, which is typically established by the programmed electronics, the puncture assembly is triggered, thereby causing the lancet 916 to penetrate the skin that has been pulled into the opening 912 of the door portion 902a. The lancet 916 is preferably triggered automatically by the activation of a solenoid valve (not shown) which causes a vacuum-activated piston (not shown) to trigger the lancet 916. In the embodiment shown in FIGS. 45a to 45e, the detector glucose 914 is inserted into a slot (not shown) of a movable projection 903 of the body portion 902b of the housing 902. The glucose detector 914 contains one or more electrical contacts (not shown) at the end inserted in the slot that is they mate with one or more electrical contacts (not shown) placed inside the slot. After the glucose detector 914 is placed within the slot of the moving projection 903, the moving projection 903 pushes inward. A bolt or other mechanism keeps the moving projection 903 in the inward position until it is fired, as discussed below. As shown in Figures 45b to 45c, when the door portion 902s is closed, a cam surface 926 inside the door portion 902a moves the movable projection and the glucose detector 914 in a direction toward the door assembly. puncture and lancet assembly 908. Although a cam surface 926 is shown in Figure 45a, other alignment approaches may also be used. The lancet 916 then triggers, penetrates the skin 924, as shown in Figure 45d, and retracts rapidly. Shortly after the lancet 916 is triggered, as discussed above, the mobile projection 903 is triggered, preferably electronically, such as by releasing a bolt or other mechanism, causing an interior portion 903a of the moving projection 903 to move. outwards, such as by a sliding mechanism, whereby the glucose detector 914 is caused to move to a position close to the position in which the lancet makes contact with the skin 924, as shown in Figure 45e , causing the 914 glucose detector to come in contact with the blood. The area of the interior of the door portion 902a immediately adjacent the opening 912 may also preferably stop the lancet assembly 908 from extending beyond the door portion 902a and prevent the lancet 916 from extending more than the lancet 916. desired inside the skin. The preferred puncture depth typically varies from about 0.5mm to about 3mm inside the skin. The door portion 902a is closed during the process of obtaining a blood sample. After the lancet 916 pierces the skin 924 and retracts, the blood is drawn, under vacuum, to and over the glucose detector 914. When a sufficient amount of blood has been collected, the glucose detector 914 generates a signal that results in the deactivation of the vacuum pump and the vacuum is released by, for example, an electronically controlled valve. Alternatively, the vacuum pump can be stopped after a pre-set time interval. The blood collection device 900 can then be removed from the individual's skin. After that, the glucose detector 914 generates a signal, as described above, which indicates the glucose level, this signal is transmitted via an electrical circuit to the electronics housed in the blood collection device 900. The signal is processed through those electronic, in the manner described above, and the results obtained from the glucose detector 914 can be displayed on a screen 920, typically a conventional liquid crystal display. Other ways of deployment can also be used. After completing the measurement, the door portion 902a can be opened and the glucose detector 914 and the lancet 916 can be replaced. Lancet 916 and glucose detector 914 can be replaced immediately after use, immediately before use, or can be replaced at any other time. Referring now to Figures 46a through 46c, representing another embodiment of the present invention, the blood extraction device 1000 comprises a housing 1002 having a door portion 1002a (shown in the closed position in Figures 46a through 46c), which is attached to the portion of body 1002b of housing 1002 by a joint in the form of a joint (not shown). Alternatively, the door portion 1002a can be attached to the body portion 1002b by friction attachment, a stop (not shown), or any combination of a hinge 1006, a friction joint, and a stop. When a joint is used, it may optionally be spring deflected to retain the door portion 1002a in the open or closed position. A stop (not shown) can be provided in the door portion 1002a to engage a protrusion (not shown) in the body portion 1002b, or vice versa, to hold the door portion 1002a in the open or closed position when desired . Although a hinge (not shown) is provided in the embodiment shown in Figures 46a through 46c, any other joint or combination of joints that allow the door portion 1002a to be attached to the body portion 1002b and alternate between open and closed positions. It is acceptable. A package or some other seal arrangement 1007 is provided to seal the housing 1002 when the door portion 1002a is closed. Alternatively, the housing 1002 may also include an inner cover portion (not shown) similar to that described in the embodiment shown in Figures 43a to 43c, which advantageously may be placed around the puncture assembly (not shown) in a manner which allows the movable inner cover portion to open and close. Any joint that allows the movable inner cover portion to attach to the body portion 1002b and alternate between an open and a closed position is acceptable. Additionally, a bolt mechanism may be included to prevent accidental opening of the door portion 1002a when the blood collection device 1000 is in use. Typically, the bolt mechanism will provide a lock connection of the door portion 1002a with the body portion 1002b.

Arranged within the housing 1002 there is a vacuum pump (not shown), a lancet assembly 1008 which generally comprises a plastic molded part 1030 to which the lancet 1016 is fixed, a puncture assembly (not shown) in which the lancet assembly 1008 is inserted, a battery (not shown), and electronics (not shown) for the purposes described hereinafter. A switch 1009 is provided to activate the electronics, which can take the form shown in Figure 3. The vacuum pump is communicated by an evacuation tube (not shown) with the volume in < missed by the door portion 1002a when the door portion 1002a is in the closed position. Optionally, a check valve (not shown) can be placed in the evacuation tube between the vacuum pump and the volume enclosed by the door portion 1002a when the door portion 1002a is in the closed position. During the sample collection process, the door portion 1002a is closed to form a seal. The seal should be sufficiently watertight so that sufficient vacuum can be obtained to remove air from the volume enclosed by the door portion 1002a when the door portion 1002a is in the closed position.

The area of the door portion 1002a of the housing 1002 that is in contact with the skin that is equipped with a seal 1010. The seal 1010 surrounds an opening 1012 in the door portion 1002a. The opening 1012 can be round, oval, rectangular, or in any other way. The opening 1012 in the door portion 1002a, allows communication between the surface of the skin and the blood collection chamber adjacent to a fluid collector, shown here in the form of a glucose detector 1014, which, may take the form of a strip. Other types of fluid collectors can also be used, and those skilled in the art will recognize that the present embodiment can easily be modified to include more than one fluid collector. Preferably, the glucose detector 1014 contains at least one opening (not shown) in about half of the glucose detector 1014 for the lancet 1016 to pass through. In this embodiment, at least one opening in about half of the glucose detector 1014 is preferably in alignment with the opening 1012 and the lancet 1016 and may be covered with a mesh. Alternatively, the glucose detector 1014 used in the embodiment shown in Figures 46a through 46c may contain a semicircular notch (not shown) in the region of the glucose detector 1014 that contacts the blood. The semicircular notch can be covered with a mesh. When in use, the blood collection device 1000 is positioned so that the puncture assembly is placed over the region on the surface of the skin from which the fluid sample is to be obtained so that the puncture assembly It is approximately perpendicular to the surface of the skin. In order to obtain the blood sample, the door portion 1002a of the housing 1002 is placed against the skin, whereby the seal 1010 surrounding the opening 1012 allows a satisfactory vacuum to be effected. The switch 1009 is activated, typically by pressing it, activating by this the electronics, described in Figure 3 and discussed above, which start the vacuum pump. The action of the vacuum pump extracts air from the volume enclosed by the door portion 1002a when the door portion 1002a is in the closed position and causes the skin circumscribed by the seal 1010 to be pulled out towards the opening 1012. This results in that the skin becomes congested with blood. Congestion of the skin with blood is accompanied by the stretching and lifting of the skin towards the opening 1012 in the door portion 1002a. After a suitable period of time, which is typically established by the programmed electronics, the puncture assembly is triggered, thereby causing the lancet 1016 to penetrate the skin that has been pulled into the opening 1012 of the door portion 1002a. The lance 1016 is preferably triggered automatically by the activation of a solenoid valve (not shown) which causes a vacuum-activated piston (not shown) to trigger the lance 1016. In the embodiment shown in FIGS. 46a to 46c, the detector of FIG. glucose 1014 is inserted into a slot 1018 of a moving projection 1003 of the body portion 1002b of the housing 1002. The glucose detector 1014 contains one or more electrical contacts (not shown) at the end inserted into the slot 1018 that engage with one or more electrical contacts (not shown) positioned within the slot 1018. Preferably, after the glucose detector 1014 is placed within the slot 1018 of the moving projection 1003, the moving projection 1003 is pushed in a retracted manner. A bolt or other mechanism keeps the moving projection 1003 in the retracted position until it is fired, as discussed below. To obtain a blood sample, the door portion 1002a is closed. As discussed above, a vacuum is created and the skin becomes congested with blood. After a suitable period of time, the lancet 1016 is triggered and, depending on the type of glucose detection being used 1014, the lancet 1016 contacts the skin moving through an opening in about half the glucose detector 1014 or moving beyond the end of the glucose detector 1014 that contains a semicircular notch. The lancet 1016 then penetrates the skin, and it retracts quickly. Shortly after the lancet 1016 is triggered and retracted, as discussed above, the mobile projection 1003 is triggered, causing the glucose detector 1014 to extend laterally across the width of the blood collection device 1000, as shown in FIG. shown by the arrow in Figure 46a, in order to get in contact with the blood. This movement may be caused by the release of a bolt. Alternatively, the glucose detector 1014 can be moved increasingly through the action of a solenoid of another electromechanical device. In one embodiment, the glucose detector 1014 can be moved via a pivoting projection 1003a, Figure 46b. In another embodiment, the glucose detector 1014 can be moved via a 4-bar link 1004, Figure 46c. The mobile projection 1003 may also comprise an extension 1025 extending laterally across the width of the blood collection device 1000. When present, the extension 1025 stops the lancet assembly 1008 from extending beyond the extension. 1025 and prevents the lancet 1016 from extending more than desired inside the skin. The preferred puncture depth typically varies from about 0.5mm to about 3mm inside the skin. After the lancet 1016 pierces the skin is retracted, the mobile projection 1003 is triggered and the glucose detector 1014 is moved, as discussed above, so that a capillary portion (not shown) of the glucose detector 1014 is by over the opening created in the skin. The blood is then drawn, with the help of the vacuum to and over the glucose detector 1014. When a sufficient amount of blood has been collected, the glucose detector 1014 generates a signal which results in the deactivation of the vacuum pump and the vacuum is released by, for example, an electronically controlled valve. Alternatively, the vacuum pump can be stopped after a pre-set time interval. The blood collection device 1000 can then be removed from the skin of the individual. After that, the glucose detector 1014 generates a signal, as described above, which indicates the glucose level, this signal is transmitted via an electrical circuit to the electronics housed in the blood collection device 1000. The signal is processed by those electronics, in the manner described above, and the results obtained from the glucose detector 1014 can be displayed on a screen 1020, typically a conventional liquid crystal digital display. Other ways of deployment can also be used. After completing the measurement, the door portion 1002a can be opened and the glucose detector 1014 and the lancet 1016 can be replaced. The lancet 1016 and the glucose detector 1014 can be replaced immediately after use, immediately before use, or can be replaced at any other time. In each of the modalities shown in the previous Figures 5 to 10 and 43 to 46, the housing in the vacuum pump, the puncture assembly, the lancet assembly, the battery, the electronics, the evacuation tube, the valve of verification, the tip assembly, the blood collection chamber, the lancet and the solenoid valve, can be made from the same materials as the corresponding components of the apparatus shown in Figures 1, 2 and 3. Seals 104, 207 , 307, 407, 507, 607, 707, 807, 907 and 1007 can be made from the same material as the seal of the tip assembly. The components shown in the above Figures from 5 to 10 and from 43 to 46 work in the same manner as do the corresponding components of the apparatus shown in Figures 1, 2 and 3.

Figure 20 illustrates a preferred installation of a puncture assembly shown in Figures 11 and 12 within a prototype of a blood collection apparatus embodiment of this invention. The puncture assembly 1200, shown in its retracted position before nailing, has been adjusted with a standard lancet assembly 1202 and a 3-way solenoid valve 1024. The cap 1206 of the puncture assembly 1200 fits into the 1207 partition of the apparatus. 1000, thereby forming an effective seal against the partition 1207. The apparatus 1000 comprises a housing 1002, which comprises a door portion 1002a and a body portion 1002b. The exit port 1008 of the puncture assembly 1200 is connected to a vacuum pump 1210 by means of a passage 1212, such as, for example, a connection tube. The passage 1212 is also connected to a cavity 1213 inside the door portion 1200a of the apparatus 1000. In this way, the vacuum pump 1210 can deliver an equal level of vacuum pressure to the cavity 1213 and to the exit port 1208. The vacuum pressure inside the cavity 1213 can be maintained at a level at which the apparatus 1000 operates, because the vacuum pump 1210 can draw the evacuated air from the cavity 1213 at a rate faster than the rate at which ambient air is filtered inside the cavity 1213 via the door seal 1007, the seal placed against the skin of a patient 1010, and the seal formed between the layer 1206 and the partition 1207 (not shown). The body 1002b of the housing 1002 of the apparatus 1000 contains air having a level of pressure equal to the ambient pressure surrounding the apparatus. The level of the pressure inside the body 1002b of the housing 1002 does not change during operation of the apparatus because the body 1002b of the housing 1002 contains a sufficient number of openings (not shown) communicating with the surrounding ambient air. The air inside the body 1002b of the housing 1002 can enter the puncture assembly 1200 through the inlet body 1214 when the solenoid valve 1204 is activated to begin the puncture step. The difference in air pressure between the ambient air inside the body 1002b of the housing 1002 and the air evacuated inside the cavity 1203 in the door portion 1200a of the housing 1002 gives approximately the differential gas pressure necessary to operate the puncture assembly . During the puncture step, the nailing movement of the lancet assembly 1202 is stopped by the stopping of the lancet 1216. The stopping of the lancet 1216 has an opening (not shown) that allows the lancet 1218 to pass through and penetrate the lancet 1218. skin that is positioned against seal 1010. The puncture assembly in Figure 20 can thus be used in a manner substantially identical to that shown in Figures 15a, 15b, and 15c. It should be noted that the designs of the various housings shown in Figures 5-14 can be modified without substantially affecting the operation of the components disposed within the housing or on the surface of the housing. For example, the shapes of the accommodations, the shapes of the door portions of the accommodations, the shapes of the housing portions of the accommodations, and the shapes of the remaining portions of the accommodations can be modified without departing from the scope and spirit of this invention. This invention provides numerous advantages over the blood collection devices of the prior art. Among these advantages are the following: 1. Ability to use parts of the body, other than the finger, as a site for blood collection; 2. Production of pain eliminating the need to prick the finger; 3. Increase in speed in the collection of blood samples by means of a pretreatment comprising a combination of stretching the skin together with heat or vacuum or both heat and vacuum; 4. Incorporation of the glucose detector in the device to extract the blood sample. The following examples illustrate several features of the present invention, but it is not intended in any way to limit the scope of the invention as presented in the claims. In the following examples, the term "perforation" and forms thereof, and the term "puncture" and forms thereof, are used interchangeably. Although the term "glucose detector" is used herein, a person of ordinary skill in the art will recognize that the apparatus and methods of the present invention can also be used to perform other diagnostic tests.

EXAMPLES Example 1 This example illustrates that larger volumes of blood can be extracted and collected by applying a vacuum, driven or continuous, after drilling, from which it can be extracted and collected when no vacuum is applied. No vacuum is applied before drilling. Each of 4 people had their forearm (dorsal forearm) operated 4 times (in four different positions on the forearm) with a "BD ULTRA-FINE" lancet in a "MEDISENSE" lancet assembly (Model number 97101) at two different vacuum levels (-2.5 psig and -5.0 psig) and for each of the different vacuum pulse frequencies (0, 0.2, 0.8, 3.2, 12.8, 25, 100 hertz). Vacuum was applied with a pipette tip that has a diameter of 8mm ("RAININ RT-200"). There were 4 control runs without a vacuum (one puncture per person). A total of 60 punctures per person was carried out. In accordance with the above, it can be seen that a total of 240 runs were carried out. The vacuum was applied for 30 seconds after the puncture. The blood was collected in capillary tubes. In the control runs, samples were collected and collected 30 seconds after the puncture. The amount of blood collected was determined by measuring the length of the blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 microliter was calculated. The sensation of pain was also recorded. The following pain ratings were used: Pain of 1 = the person did not place anything or is not sure that something was felt. Pain of 2 = the person felt a defined picket not as painful as the piercing of the finger by the standard finger lancet. Pain of 3 = the person felt definite pain, approximately equal to a finger prick using a standard finger lancet.

The results of blood collection are presented in Table 1.

Without vacuum, the average volume of blood collected was 0.8 microliters and 31% of the samples collected contained more than one microliter. The pain results were as follows: Pain of 1 = 81% 10 Pain of 2 = 17% Pain of 3 = 2% The control runs (without vacuum) provided much lower volumes of blood collected than did the runs in those who applied the vacuum. The increased vacuum resulted in larger volumes of blood drawn. The pain was minimal, with only 2% of the punctures that resulted in pain compared to that resulting from piercing the finger.

Example 2 This example illustrates the application of vacuum before drilling as well as the results after drilling in a larger volume of blood drawn than does the application of voids only after drilling. Each of 4 people had their forearm punctured (dorsal forearm, mid forearm) 16 times (at 16 different forearm positions) with a "BD ULTRA-FINE" lancet in a modified "MEDISENSE" lancet assembly at 4 different Vacuum levels. The 4 vacuum levels used were -2.5, -5.0, -7.5 and -10.0 psig. The "MEDISENSE" lancet device was modified to allow the vacuum to be pulled through the lancet assembly. Four punctures per person were carried out in each of the four levels of continuous vacuum. In accordance with the above, it can be seen that a total of 64 runs were carried out. Before puncture, vacuum was applied for a period of 30 seconds; After the puncture, the vacuum was applied for a period of 30 seconds. The skin was under vacuum at the time the lancet was fired. After the lancet was fired, the lancet assembly was removed, and the vacuum was used to apply the same level of vacuum as that which had been used for the vacuum prior to the puncture. The vacuum, before or both before the puncture and after the puncture, was applied with a pipette tip that has a diameter of 8mm. ("RAININ RT-200"). The pipette tip of the vacuum device was maintained at the level of the plane of the skin. The blood was then collected in capillary tubes. The amount of blood collected was determined by measuring the length of the blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 microliter was calculated. The sensation of pain was also recorded. The results of the blood collection are presented in TABLE II TABLE II The results of the pain were as follows: Pain of 1 = 58% Pain of 2 = 31% Pain of 3 = 11% An almost linear relationship was observed between the level of vacuum and the volume of blood collected. The average volume of blood collected with the vacuum applied before and after the perforation was approximately twice that collected with the vacuum applied only after the application without applying vacuum before perforation. See the results of example 1 for this comparison (7.8 microliters versus 3.1 microliters). The volume of blood collected was always above one microliter for all vacuum levels, except for -2.5psig.

Example 3 This example illustrates that the localized heat of the area to be drilled followed by the vacuum after drilling results in a greater volume of blood drawn than does the extraction with only the vacuum after drilling. Each of 4 people made his forearm (dorsal forearm, middle part of the forearm) will be punctured 8 times (in 8 different positions on the forearm) with a "BD ULTRA-FINE" lancet, in a "MEDISENSE" lancet assembly with applied heat (45 ° C) before Drilling during two periods of different times, 15 seconds and 60 seconds. It was carried out a total of 32 runs, 16 runs where the duration of preheating was 15 seconds and 16 runs where the duration of preheating was 60 seconds. Heat was applied with a heating block, which was an aluminum block having a square face covered with a "KAPTON" film heating element controlled by a "OMEGA" DP41 temperature controller using a T-type thermocouple. Vacuum was applied after each puncture for 30 seconds at -5.0 psig. The blood was collected in capillary tubes. The amount of blood collected was determined by measuring the length of the blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.0 microliter was calculated. The pain was also recorded. The results of the blood collection are presented in TABLE III.

TABLE III The pain results are as follows: Pain of 1 = 91% Pain of 2 = 9% Pain of 3 = 0% The average volume of blood collected using the preheating duration of 15 seconds was more than twice the average volume of blood collected after a vacuum level after the puncture of -5.0psig, without preheating. See the results of example 1 for this comparison (6.91 microliters vs 3. l microliters). The average volume of blood collected using a preheat with a duration of 60 seconds was approximately 4 times the average volume of blood collected at a vacuum level after the puncture of -5.0psig, without preheating. See the results of example 1 for this comparison (11.6 microliters vs 3. l microliters).

EXAMPLE 4 This example illustrates the effect on blood drawing of the stretching of the skin upwards with a vacuum. Each of 4 people made his forearm (dorsal forearm, middle part of the forearm) will be punctured 8 times (in 8 different positions on the forearm) with a lancet "BD ULTRA-FINE", in a lancet assembly "MEDISENSE" was applied empty for a period of 30 seconds before of the puncture at -5.0psig using two different vacuum devices. The first apparatus was a vacuum device with a diameter of 15mm (ie a hollow cylindrical tube) used without a network stretched through the opening of the tube, the second device was an ISmm device in diameter (ie a cylindrical tube) hollow) used with a network traversed in the opening of the tube. The net prevented the skin from rising towards the vacuum apparatus. The same vacuum apparatus used before the puncture was applied for a period of 30 seconds after puncture. The device remained level with the plane of the skin. Four punctures were performed per person per condition (without network, with network). In accordance with the above, it can be seen that a total of 32 runs were carried out. The blood was collected in capillary tubes. The amount of blood collected was determined by measuring the length of the blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1. Omicrolitres was calculated. The sensation of pain was also recorded. The results of the blood collection are presented in TABLE IV. TABLE IV Red through the Average Volume of Percentage of blood sample point samples that have collected lml of blood collected. NO 5.2 87 YES 0.6 19 The pain results are as follows: Pain of 1 = 94% Pain of 2 = 6% Pain of 3 = 0% The magnitude of the difference in volume of blood collected and the success rates ( that is, the percentage of samples that have more than 1 microliter of blood collected) between the condition of stretching the skin in combination with a vacuum and the condition of not stretching the skin in combination with a vacuum was unexpected. The pain ratings were low. This example demonstrates that the combination of stretching the skin and applying vacuum significantly increased the volume of blood drawn.

EXAMPLE 5 This example illustrates the effect that the area of the extraction site has on the volume of blood collected. Each of 4 people made his forearm (dorsal forearm, middle part of the forearm) will be punctured to 32 different positions on the forearm with a lancet "BD ULTRA-FINE", in a modified lancet assembly "MEDISENSE" the lancet assembly "MEDISENSE" has been modified with a spring more powerful and a port was added. Vacuum was applied for less than 5 seconds before puncture. The forearm was punctured under vacuum either -5.0psig or less 7.5psig. the applied vacuum was maintained for 30 seconds after the puncture. The diameter of the pipette tip used to apply the vacuum after the puncture was varied, with diameters of 4, 6, 8 and 10mm. Four punctures were carried out per condition (diameter, vacuum level). In accordance with this, it can be seen that a total of 128 runs were carried out. The blood was collected in capillary tubes. The amount of blood collected was determined by measuring the length of the blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1. Omicrolitres was calculated. The sensation of pain was also recorded. The results of the blood collection are presented in TABLES VA and VB.

TABLE VA Vacuum level = 5.0psig TABLE VB Vacuum level = 7.5psig The pain results are as follows: Pain of 1 = 89% Pain of 2 = 10% Pain of 3 = 1% The volume of blood collected and the success rates (ie, the percentage of samples that have more than microliter of collected blood) was found to vary directly with the area of skin raised in the device by vacuum. A much larger volume of skin was raised in the pipette tip of larger diameter than in the smaller pipette tips. EXAMPLE 6 This example illustrates that a multi-tip plastic lancet can be used with heat and vacuum to collect a useful amount of blood. Each of 4 people made his forearm (dorsal forearm, middle part of the forearm) will be punctured 16 times (in 16 different positions on the forearm) with a Greer Derma PIK * System for allergy test (Greer Laboratories, Inc., Lenoir, North Carolina 28645) modified to fit into a "MEDISENSE" lancet assembly. The heating was carried out at approximately 40 ° C and 45 ° C for 15 and 60 seconds before puncture. Four punctures were carried out per condition (temperature, time) per person. In accordance with the above, it can be seen that a total of 64 runs were carried out.

Heat was applied with a heating block, which comprised an aluminum block that had a face covered with a "KAPTON" film heating element controlled by a "OMEGA" DP41 temperature controller using a T-type thermocouple and the opposite face in contact with a larger base of a truncated cone made of copper. The greater base of the cone conecado had a diameter of 1.27cms. The height of the cone conecado was 1.27cms. The smaller base of the cone conecado had a diameter of 0.89cms. The smaller base had a cylindrical opening that had a diameter of 0.32cms. The cylindrical opening had a common axis with the truncated cone. The cylindrical opening reduced the heating surface of the copper truncated cone. Vacuum (-5.0psig) was applied during a period of 30 seconds after the puncture. The vacuum in contact with the skin was formed by a pipette tip that had a diameter of 8mm. The pipette tip remained level in the plane of the skin. The blood was collected in capillary tubes. The amount of blood collected was determined by measuring the length of the blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1. Omicrolitres was calculated. The sensation of pain was also recorded. The results of the blood collection are presented in TABLE VI.

TABLE VI The pain results are as follows: Pain of 1 = 100% Pain of 2 = 0% Pain of 3 = 0% This example demonstrates that a blood extraction process employing a multi-tip plastic lancet, heating before puncture, skin tightening, and vacuum after puncture, can extract at least 1 ml of blood and when less 50% of the time.

EXAMPLE 7 A prototype puncture assembly of this invention was tested in vitro for its systematic behavior using a "BD ULTRAFINE" lancet and a solenoid valve supplied by Lee Co, Model number LHDA0511111H. The design parameters of the prototype are listed below. The definitions of these parameters were previously established.

At 30.7mm2 (diameter = 6.25mm) M = 1.2 grams S = lOmm Xp = n / a Ks = 19.5N / m ^ 8.7mm Cv = 0.015 Dtv = 0.7msec Vc = 0.01 ce Vv = 5cc Pa = 14.7 psia (= 0 psig) Pv = 6.7 psia (= -8.0 psig) Ta = 25 ° C Ff = 0.13 N-0.18N This configuration resulted in good puncture results when tested on human subjects. The measured speed of the lancet at the end of the race was 2.7 minutes per second.

EXAMPLE 8 Multilayer elements were prepared comprising the following layers, from top to bottom. (1) layer that can be put in contact with the meter (2) detection layer (3) overcoat layer (4) blood transport layer (5) cover layer. The arrangement of the layers is shown systematically in Figures 21a and 21b. However, the overcoat layer is substantially coplanar with the blood transport layer as shown in Figure 28. The layer that can be contacted with the meter 1114 was approximately 5.5mm wide and approximately 40mm long. The layer that can be contacted with the meter was made of polyvinyl chloride. An opening of 1.5mm in diameter was drilled in the layer that can be put in contact with the meter. The detection layer 1110 was printed on the screen on the layer that can be brought into contact with the meter. Through the opening in the layer that can be brought into contact with the meter, a mesh layer was placed which served as the blood transport layer 1108. The mesh was the mesh previously identified as NY151 HC. Detection layer 1110 was of the detection layer type described in U.S. Patent No. 5,682,884. The overcoat layer 1123 was printed on the screen around the periphery of the mesh layer. The cover layer 1104 was approximately 5.5mm wide and was a little shorter than the layer that can be contacted with the meter so that the electrical contacts 1110a of the detection layer 1110 were exposed. The cover layer was made of polyester. An aperture in the oval-shaped cover layer was drilled 2.5mm by 3.7mm before assembling the multi-layer element. The multi-layer element placed in the apparatus as shown in Figures 29a, 29b, 29c and 29d. The device was placed in contact with the forearm of a volunteer who was diabetic. See Figure 29a. The skin of the forearm was stretched and raised toward the tip, where it was close to or in contact with the cover layer 1102 of the multi-layered element. See Figure 29b. After the vacuum was applied for 5 seconds, the lancet was fired into the skin by means of a lancet-driven lancet assembly. The lancet passed through the opening 1116 in the layer that can be brought into contact with the meter 1114 and the opening 1104 in the cover layer 1102. See Figure 29c. The lancet retracted and the blood started to come out of the diabetic volunteer's forearm. The vacuum assisted in the extraction of blood until the blood reached the 1108 mesh layer. See Figure 29d. The blood was then transported along the mesh until it reached the detection layer 1110 of the multi-layered element. When the blood reached the detection layer of the multi-layer element, an electric current was generated. This current was used to determine when to clear the vacuum. The electric current was also an indication of the blood glucose level of the volunteer. Seven diabetic volunteers were examined as described in the previous paragraph. The time required for the multi-layered element to be filled after the puncture operation was recorded. It was considered that the multiple layer element was full when a current of 1.5μA was generated. The vacuum was then released and the current was recorded for 20 seconds. During the last 5 seconds of the measurement period of 20 seconds, the current was integrated. Integrated current (ie load) was recorded. The puncture procedure and the data collection were repeated 4 times per volunteer. All 28 puncture procedures resulted in the blood filling the multi-layered element in less than 40 seconds. The average time required to fill the multi-layered element was 7 seconds. Figure 30 shows the average load of the 4 trials as a function of blood glucose level of each volunteer. The glucose level was determined by drawing blood from a finger and measuring the glucose level in a YSI 2300 glucose analyzer. The load increased linearly with the blood glucose level of the volunteer. The volunteers were asked to rate the lancet pain in the forearm. The pain in the forearm lancet was seen to be less than the pain of the finger lancet as shown in Figure 31.

EXAMPLE 9 Multilayer elements were prepared comprising the following layers, from top to bottom. (1) layer that can be put in contact with the meter (2) detection layer (3) overcoat layer (4) blood transport layer (5) cover layer. The arrangement of the layers is shown systematically in Figures 21a and 21b. However, the overcoat layer is substantially coplanar with the blood transport layer as shown in Figure 28. The layer that can be contacted with the meter 1114 was approximately 5.5mm wide and approximately 40mm long. The layer that can be put in contact with the meter was made of polyester. An opening of 2. Omm diameter was drilled in the layer that can be put in contact with the meter. The detection layer 1110 was printed on the screen on the layer that can be brought into contact with the meter. Through the opening in the layer that can be brought into contact with the meter a mesh layer was placed, which served as the blood transport layer 1108. The mesh was the mesh previously identified as NY151 HC. A section of the mesh (1.5mm in diameter) was drilled by means of a hole punch. See Figure 25. Detection layer 1110 was of the detection layer type described in U.S. Patent No. 5,682,884. The overcoat layer 1123 was printed on the screen around the periphery of the mesh layer. The cover layer 1102 was approximately 5.5mm wide and was a little shorter than the layer that can be contacted with the meter so that the electrical contacts 1110a of the detection layer 1110 were exposed. The cover layer was made of polyester. An aperture in the oval-shaped cover layer was drilled 2.5mm by 3.7mm before assembling the multi-layer element.

The multi-layer element placed in the apparatus as shown in Figures 29a, 29b, 29c and 29d. A vacuum of 7.5psig was applied. The device was placed in contact with the forearm of a volunteer. See Figure 29a. The skin of the forearm was stretched and raised toward the tip, where it was close to or in contact with the cover layer 1102 of the multi-layered element. See Figure 29b. After the vacuum was applied for 5 seconds, the lancet was shot into the skin by means of a pneumatic puncture assembly. Of the type shown in Figures 11, 12, 13, and 14. The lancet passed through the opening 1116 in the layer that can be contacted with the meter 1114 and the opening 1104 in the cover layer 1102. See Figure 29c The lancet retracted and the blood began to come out of the volunteer's forearm. The vacuum assisted in the extraction of blood until the blood reached the 1108 mesh. See Figure 29d. The blood was then transported along the mesh until it reached the detection layer 1110 of the multi-layered element. When the blood reached the detection layer of the multi-layered element, an electric current was generated. This current was used to determine when to release the vacuum. 8 volunteers were examined as described in the previous paragraph. The time required for the multilayer element to be filled after the puncture operation was recorded. It was considered that the multiple layer element was full when a current of 1.5μA was generated. The vacuum was then released and the integrated current was recorded. The puncture procedure and the data collection were repeated 4 times per volunteer. The blood filled the multi-layered element in less 40 seconds during 97% of the tests. The average time required to fill the multi-layer element was 15.9 seconds.

EXAMPLE 10 Multilayer elements were prepared comprising the following layers, from top to bottom. (1) layer that can be brought into contact with the meter (2) detection layer (3) overcoating layer (4) blood transport layer (5) cover layer. The arrangement of the layers is shown schematically in Figures 21a and 21b. Nevertheless, the overcoat layer is substantially coplanar with the blood transport layer as shown in Figure 28. The layer that can be contacted with the meter 1114 was approximately 5.5mm wide and approximately 4Omm long. The layer that can be put in contact with the meter was made of polyester. Two types of layers were prepared that can be brought into contact with the meter. In the first type, it perforated an opening in the layer that can be brought into contact with the meter. This opening had a diameter of 2. Omm. No mesh was placed through this opening. See Figure 26b. In the second type, two openings were drilled in the layer that can be brought into contact with the meter. One opening had a diameter of 2. Omm, the other opening had a diameter of 1.5mm. The second opening was located 2mm from the first opening. See Figure 26a. The detection layer 1110 was printed on the screen on the layer that can be brought into contact with the meter. Through the 1.5mm opening in the layer that can be contacted with the meter, a mesh layer was placed which served as the blood transport layer 1108. The mesh was the mesh previously identified as NY151 HC. Detection layer 1110 was of the detection layer type described in U.S. Patent No. 5,682,884. The overcoat layer 1123 was printed on the screen around the periphery of the mesh layer. The cover layer 1102 was approximately 5.5mm wide and was a little shorter than the layer that can be contacted with the meter so that the electrical contacts 1110a of the detection layer 1110 were exposed. The cover layer was made of polyester. An aperture in the oval-shaped cover layer was drilled 2.5mm by 3.7mm before assembling the multi-layer element. The multi-layer element placed in the apparatus as shown in Figures 29a, 29b, 29c and 29d. A vacuum of -7.5psig was applied. The device was placed in contact with the forearm of a volunteer. See Figure 29a. The skin of the forearm was stretched and raised toward the tip, where it was close to or in contact with the cover layer 1102 of the multi-layered element. See Figure 29b. After the vacuum was applied for 5 seconds, the lancet was fired into the skin by means of a pneumatic lancet assembly. This pneumatic lancet assembly was the assembly shown in Figures 16 and 17. The lancet passed through the opening of 2. Omm 1116 in the layer that can be contacted with the meter 1114 and the opening 1104 in the cover layer 1102. See Figure 29c. The lancet retracted and the blood began to come out of the volunteer's forearm. See Figure 29d. As fast as possible, the multi-layer element slid about 2mm in the direction away from the electrical contacts. This type of movement is described more fully in the discussion of Figures 46a through 46c. The movement of the multi-layered element caused the site of the opening in the skin to be in vertical alignment with the mesh 1108 of the multi-layered element. In the case of the layer that can be contacted with the meter having two openings, this was the site of the opening 1122 that was 1.5mm in diameter. The vacuum assisted in the extraction of blood until the blood reached the 1108 mesh. The blood was then transported along the mesh until it reached the detection layer 1110 of the multi-layered element. When the blood reached the detection layer of the multi-layered element, an electric current was generated. This current was used to determine when to release the vacuum. 9 non-diabetic volunteers were examined as described in the previous paragraph. Each volunteer was examined with each type of multi-layer element. The time required for the multi-layered element to be filled after the puncture operation was recorded. It was considered that the multiple layer element was full when a current of 1.5μA was generated. The emptiness was then released. The puncture procedure and data collection was repeated 8 times per volunteer per item. The blood filled the multi-layered element that had an opening in the layer that can be brought into contact with the meter in less than 42 seconds for 95% of the tests. The blood filled the multi-layered element that had two openings in the layer that can be contacted with the meter in less than 40 seconds for 96% of the tests. The average time required to fill the multi-layer element having two openings in the layer that can be brought into contact with the meter was 14 seconds. The average time required to fill the multi-layered element having an opening in the layer that can be brought into contact with the meter was 11 seconds.

EXAMPLE 11 This example illustrates the effect of the size and shape of the tip on the volume of blood drawn. Each of 21 volunteers was examined 30 times on the dorsal forearm using a modified "MediSense" lancet puncture assembly "BD ULTRA-FINE" (Becton-Dickinson) .The MediSense puncture assembly was modified with a port to allow a vacuum will suck through the puncture assembly.The tips tested in this example were screwed onto the body of a MediSense puncture assembly in place of the conventional nose.A vacuum (-7.5psig) was applied for 10 seconds before the After the puncture, blood was collected for 30 seconds at -7.5psig.The same tip that was used, before the puncture, was used for blood collection.The openings formed in the skin had a depth of 1.6mm. . different tip assemblies were evaluated. These assemblies are shown in Figure 33. The diameter of the opening in the lower base of the tip (See line "ef" in Figure 32) varied from 9.53 to 19.05mm. The diameter of the opening in the lower base of the tip for the tip assemblies 1, 2, and 3 was 9.53mm. The diameter of the opening in the lower base of the tip for the tip assemblies 4, 5, 6 and 7 was 12.70mm. The diameter of the opening in the lower base of the tip for the tip assemblies 8, 9, 10 and 11 was 15.88mm. The diameter of the opening in the lower base of the tip for the tip assemblies 12, 13, 14, and 15 was 19.05mm. The distances from the ring to the seal for the tips (See the line "bg" in Figure 32) ranged from 1.6mm to 6.Omm. The distance from the ring to the seal for the tips 1, 4, 8 and 12 was 1.6mm. The distance from the ring to the seal for tips 2, 5, 9, and 13 was 3.0mm. The distance from the ring to the seal for tips 3, 6, 10 and 14 were 4.5mm. The distance from the ring to the seal for tips 7, 11, and 15 was 6. Omm. The tips shown in Figure 33 have seals made of Buna N rubber. The thickness of the seals (see line "eh" in Figure 32) was 1.6mm and the width of the sealing surface (see line "hj"). "in Figure 32) was 3. Imm. The tips had vertical walls.

Two tests were carried out by tip assemblies per volunteer. Blood was collected in capillary tubes. The amount of blood collected was determined by measuring the distance the blood traveled in the tube. The average amount of blood collected for each of the 15 assemblies and the percentage of collections in which the amount of blood exceeded 1. Omicrolitres was calculated. The results are presented in TABAL VII. TABLE VII The volume of blood collected and the percentage of collections exceeding 1 microliter were affected both by the diameter of the opening of the lower base of the tip and by the distance from the ring to the seal of the tip. Large increases in the volume of blood collected were seen with tip assemblies 6 and 7.

EXAMPLE 12 This example illustrates the effect of decreasing the inner wall of the tip over time to draw blood from a person. Multilayer elements were prepared comprising the following layers, from top to bottom. (1) layer that can be brought into contact with the meter (2) detection layer (3) overcoating layer (4) blood transport layer (5) cover layer. The arrangement of the layers is shown schematically in Figures 21a and 21b. However, the overcoat layer is substantially coplanar with the blood transport layer as shown in Figure 28. The use of a tip with a detector is shown in Figures 34a, 34bm 34c, and 34d. The detector 1302 was placed below the puncture assembly 1304 with the openings in the detector aligned with the lancet 1306. The detector 1302 was placed between a lancet arrest 1308 that contained an opening 1309 (shown in dotted lines) and a spike assembly 1310. The tip assembly included a tip 1311 and a seal 1312 that contacted the skin "S". The puncture assembly 1304 before the vacuum application is shown in Figure 34a. The tip assembly was placed against the forearm of a volunteer. After the vacuum application (-7.5psig), the skin was stretched near or in contact with the detector as shown in Figure 34b. The vacuum was applied for a sufficient amount of time (Seconds), to make the blood on the skin inside the tip accumulate. The lancet was fired through the openings in the lancet retainer and detector, as shown in Figure 34c. The lancet penetrated the skin. The lancet retracted as shown in Figure 34d. The blood came out of the opening formed in the skin, aided by the vacuum and the stretching of the skin. The vacuum helped in the extraction of blood until the blood reached the layer that carries blood. Blood "D" was transported along the blood transporting layer until it reached the detection layer of the multilayer element. When the blood reached the detection layer of the multi-layer element, an electric current was generated. This current was used to determine when to release the vacuum, and the skin came out of the tip. The detector could then be used to use the blood to determine an analyte such as glucose. It should be noted that stopping the lancet is optional. The same detector can be used to stop the lancet. If the detector is used to stop the lancet, the thickness of the detector is important, because it will determine the penetration depth of the lancet. The type of multi-layer elements used in this example had an opening in the layer that can be brought into contact with the meter, as shown in Figures 21a and 21b. Five varieties of tips were used in this example.

Those tips are shown in cross section in Figure 35. The tips varied in the areas of the opening in the upper base, and the distance from the lower base in which the decrease in the interior wall began. The diameters "d" of the openings in the upper base for each tip were the following: The distance from ring to seal (see line "bg" in Figure 32), 4.5mm, and the diameter of the opening in the lower base of the tip (see line "ef" in Figure 32), 12.7mm was the same for the 5 tips. The tip assemblies shown in Figure 35 had seals made of Buna N rubber, with durometer hardness 40a. The thickness of the seals (see line "eh" in Figure 32) was 1mm and the width of the seal surface (see line "hj" in Figure 32) was 3mm. 8 volunteers were examined as described above. Each volunteer was examined 10 times with the tip a and four times with each of the remaining tips, b, c, d and e in Figure 35. The type required to fill the registered multiple layer element faith. The element was considered to be full when a current of 1.5 microamperes (μA) was generated by the element. The emptiness was then released. The average time required to reach 1.5μA for each tip was calculated and shown in Figure 36. The smaller diameter of the opening in the upper base, the shorter the time required to fill the detector.

EXAMPLE 13 This example illustrates the aspect of decreasing the inner wall of the tip over time to draw blood and the successful extraction of blood from a volunteer from which to draw blood was typically difficult. The experiment was carried out as described in example 12 with the following exceptions. Only tips that had the configurations of points a and b in the example were used. The diameter of the opening in the upper base at tip b was 4mm instead of the 3mm opening used in example 12. The volunteer was examined 10 times using point a. The volunteer was also examined 10 times with the tip b. The average time required to fill the multi-layer element for the elements that were filled in 40 seconds or less was calculated and shown in Figure 37. The percentage of the multi-layer elements that were filled in 40 seconds or less was calculated and calculated. are shown in Figure 38.

The tip that had the opening in the upper base that had a smaller diameter than the diameter of the opening in the lower base, tip d, was filled in less than half the time required by a tip where the diameter of the opening in the upper base was equal to the diameter of the opening in the lower base, point a. The percentage of multiple layer elements that were filled in less than 40 seconds was significantly improved for tip b, compared to tip a.

EXAMPLE 14 This example illustrates the effect of the shape of the opening in the upper base of the time required to draw blood from a person. Multilayer elements were prepared comprising the following layers, from top to bot (1) layer that can be put in contact with the meter (2) detection layer (3) overcoat layer (4) blood transport layer (5) cover layer. The arrangement of the layers is shown schematically in Figures 21a and 21b. However, the overcoat layer is substantially coplanar with the blood transport layer as shown in Figure 28.

The use of a tip with a detector is shown in Figures 34a, 34bm 34c, and 34d. The detector 1302 was placed below the puncture assembly 1304 with the openings in the detector aligned with the lancet 1306. The detector 1302 was placed between a lancet arrest 1308 that contained an opening 1309 (shown in dotted lines) and a spike assembly 1310. The tip assembly 1310 included a tip 1311 and a seal 1312 that contacted the skin "S". The puncture assembly 1304 before the vacuum application is shown in Figure 34A. The tip assembly 1304 was placed against the forearm of a volunteer. After the vacuum application (-7.5psig), the skin was stretched near or in contact with the detector as shown in Figure 34b. The vacuum was applied for a sufficient amount of time (5 seconds), to make the blood on the skin inside the tip accumulate. The lancet was fired through the openings in the lancet retainer and detector, as shown in Figure 34c. The lancet penetrated the skin. The lancet retracted as shown in Figure 34d. The blood came out of the opening formed in the skin, aided by the vacuum and the stretching of the skin. As quickly as possible, the multi-layered element slid about 2mm in the direction away from the electrical contacts. This type of movement is described more fully in the discussion of Figures 46a through 46c. The vacuum helped in the extraction of blood until the blood reached the layer that carries blood. Blood "D" was transported along the blood transporting layer until it reached the detection layer of the multilayer element. When the blood reached the detection layer of the multi-layer element, an electric current was generated. This current was used to determine when to release the vacuum, and the skin came out of the tip. The detector could then be used to use the blood to determine an analyte such as glucose. It should be noted that stopping the lancet is optional. The same detector can be used to stop the lancet. If the detector is used to stop the lancet, the thickness of the detector is important, because it will determine the penetration depth of the lancet. The type of multi-layer elements used in this example has two openings in the layer that can be brought into contact with the meter, as shown in Figure 26a. An automatic puncture assembly was used to fire the lancet. The pneumatic puncture assembly was the type of puncture assembly described in Figures 16 and 17. Five variations of spike assemblies were used in this example. They are shown in top view in cross section in Figure 39. The tips varied in the depth of the ring (see line "ab" in Figure 32) and in the shape of the opening in the upper base. The distance from the ring to the seal plus the depth of the ring, 4. Omm, (see line "bg" plus line "ab" in Figure 32), and the diameter of the opening at the bottom base of the tip, 12.7 mm (see line "ef" in Figure 32) was the same for the 5 points. 8 volunteers were examined in the dorsal forearm as described above. Each volunteer was examined 4 times with each of the 5 tips, for a total of 20 tests per volunteer. The time to fill the detector after puncture was recorded. It was considered that the detector was already full when a current of 1.5μA was generated. The emptiness was then released. The average time required to reach a current of 1.5μA for the 5 tips was calculated and shown in TABLE VIII.

TABLE VIII The tips, as shown in Figure 39, had seal made of Buna N rubber, with 40a durometry. The thickness of the seal (see line "eh" in Figure 32) was 1.6 mm and the width of the sealed surface (see line "hj" in Figure 32) was 3. Imm. For a given shaped opening, the tips that had rings of lesser depth, required less time to fill the detector than required the tips that had rings of greater depth. For a given ring depth, the tips having oval ring aperture required less time to fill the detector than required by the tips having circular ring openings. EXAMPLE 15 This example illustrates the effect of different sealing materials on the ability to form a good vacuum seal on a furry arm. Seals of sheets of different sealing materials were punched. The other materials are listed in TABLE IX. The seals, which were circular in shape, had a sealing surface thickness (see line "hj" in Figure 32) of 3.1.mm. Each seal was then used on a tip, as shown in Figure 32. The seals were attached to the inner base of the tip by means of an adhesive. The distance of the ring to the lower base of the tip before the union of the seal was 1.5mm. After the union of the seal the distance of the ring to the seal of the tip was variable, due to the differences in the thickness of the seal. A vacuum port was attached to the tip to allow a vacuum source to suction through the tip. An air flow meter (Alicat Scientific Tucson, Arizona, Model # PFM200SCCM-D-S-A) was joined between the vacuum source and the tip. The tip was attached to a bra. The combined weight of the tip and the fastener was 230 grams. A male volunteer was chosen who had more hair on his dorsal forearm than the average male population. The volunteer placed his arm against the tip seal in order to put the full weight of the tip and the bra against the arm. The purpose of this device was to provide constant pressure. A vacuum of -8psig was applied. The ability of the seal to seal on the skin was measured by the amount of air that escaped to the tip, as measured by the air flow meter in units of standard cubic centimeters per minute.

(SCCM). The measurement was repeated to a total of 20 locations on the forearm of the volunteer for each of the types of stamps. The average escape rate at the 20 forearm sites for each of the seal materials is shown in Figure 40. All materials were able to limit the average escape rate to below 40SCCM per minute standard on the volunteer. The exhaust regime is important because the size of the vacuum pump required is directly proportional to the exhaust regime. In addition, a low exhaust regime will result in an improvement in battery life. A small vacuum pump can be used with a low exhaust leakage regime. The low leak rates obtained allow a commercially available miniature vacuum pump, such as that available from T-Squared Manufacturing Company, Nutley, NJ, and having part number T2-03, 08.004, to be used with the device. The low exhaust regimes obtained with the tested seal materials mean that the cumbersome methods of attaching the tip of the skin to achieve a good seal are not necessary. Other methods of joining the tip to the skin to form a vacuum seal are not preferred. An adhesive is not preferred because it would make it difficult to remove the tip assembly, and would cause the user pain when removing the seal. Fat is not preferred because it leaves a residue after finishing the test.

TABLE IX EXAMPLE 16 This example illustrates the effect of different sealing materials on the amount of blood drawn from a person. Each of 4 volunteers was examined 32 times in the dorsal forearm by a modified MediSense puncture assembly using a "BD ULTRA-FINE" lancet. The MediSense puncture assembly had been modified with a port to allow a vacuum to suction through the puncture assembly. The tips tested in this example were screwed into the body of the MediSense puncture assembly instead of the conventional tip. A vacuum was applied (-7.5psig) for 5 seconds before puncture. The blood was collected after the puncture for 30 seconds at -7.5psig using the same tip that was used before the puncture. The fixation of the depth of the lancet was 1.6mm. 8 different tip assemblies were evaluated. Four tests conducted by tip assembly per volunteer were carried out. The blood was collected in capillary tubes. The amount of blood collected was determined by measuring the length of blood in the tube. The average amount of blood collected for each of the 8 tip assemblies is shown in Figure 41. For the 8 different tip assemblies, the diameter of the opening in the lower base (see line "ef" in Figure 32) was 10mm, the diameter of the opening in the upper base (see the line "cd" in Figure 32) was 4mm , the ring distance to the seal (see line "bg" in Figure 32) was 3mm and the width of the sealing surface (see line "hj" in Figure 32) was 3. mmmm. The tip assemblies differed in the material used for the tip seal and in the thickness of the seal. The 8 variations of the seal material and the thicknesses thereof are listed in TABLE X.

TABLE X The 8 different tip seal materials sealed well enough on the skin to allow extraction of an average greater than 3 microliters of blood in 30 seconds. The hardest material of the 8 tested, Buna N-durometry 60a, had the highest blood draw rate. By increasing the blood thickness from 1.6 to 3.2mm, it had little effect on the volume of blood collected in 30seconds.

EXAMPLE 17 This example illustrates the effect of using a novel seal on the time required to draw blood from a person. Multilayer elements were prepared comprising the following layers, from top to bottom. (1) layer that can be put in contact with the meter (2) detection layer (3) overcoat layer (4) blood transport layer (5) cover layer. The arrangement of the layers is shown schematically in Figures 21a and 21b. However, the overcoat layer is substantially coplanar with the blood transport layer as shown in Figure 28. The use of a tip with a detector is shown in Figures 34a, 34bm 34c, and 34d. The detector 1302 was placed below the puncture assembly 1304 with the openings in the detector aligned with the lancet 1306. The detector 1302 was placed between a lancet arrest 1308 that contained an opening 1309 (shown in dotted lines) and a spike assembly 1310. The tip assembly included a tip 1311 and a seal 1312 that contacted the skin "S". The puncture assembly 1304 before the vacuum application is shown in Figure 34a. The tip assembly was placed against the forearm of a volunteer. After the vacuum application (-7.5psig), the skin was stretched near or in contact with the detector as shown in Figure 34b. Vacuum was applied for a sufficient amount of time (5seconds), to cause the blood on the skin inside the tip to accumulate. The lancet was fired through the openings in the lancet retainer and detector, as shown in Figure 34c. The lancet penetrated the skin. The lancet retracted as shown in Figure 34d. The blood came out of the opening formed in the skin, aided by the vacuum and the stretching of the skin. The vacuum helped in the extraction of blood until the blood reached the layer that carries blood. Blood "D" was transported along the blood-carrying layer until it reached the multilayer layer detection layer. When the blood reached the detection layer of the multi-layer element, an electric current was generated. This current was used to determine when to release the vacuum, and the skin came out of the tip. The detector could then be used to use the blood to determine an analyte such as glucose. It should be noted that stopping the lancet is optional. The same detector can be used to stop the lancet. If the detector is used to stop the lancet, the thickness of the detector is important, because it will determine the penetration depth of the lancet.

A pneumatic lancet assembly was used to fire the lancet. The pneumatic puncture assembly was of the puncture assembly type described in Figures 11, 12, 13, and 14. The type of multilayer elements used in this example had an opening in the layer that can be brought into contact with the meter, as shown in Figures 21a and 21b. Two variations of tip assembly were used in this example. The size and structure of both tips in the tip assemblies were the same as those of tip B of Figure 35, except that the diameter of the opening in the upper base was increased to 4mm. One tip had a flat Buna-N seal, of durometry 40 (see Figure 32). The other end had a seal of the type shown in Figures 21a and 2IB in cross section, hereinafter called flexible seal. The flexible seal made contact with a larger area of the skin than the flat seal did. The flexible seal can then cause more skin to be put into the internal spiky space when a vacuum is applied than a flat seal. The flexible seal was made of 40A hardness silicone. The flexible seal 3020 can be attached to the tip 3022 by means of a mechanical joint 3024 or by means of an adhesive.

The portion 3026 of the flexible seal that is not attached to the tip 3022 is capable of moving between a first position, as shown in Figure 42A and a second position as shown in Figure 42B. In the first position, the unattached portion 3026 of the flexible seal 3020 is dependent on the lower base 3028 of the tip 3022 as shown in Figures 42A. In the second position, the unattached portion 3026 of the flexible seal 3020 contacts the lower base 3028 of the tip 3022 so that a larger surface of the unattached portion of the seal is in face-to-face contact with the lower base 3028 of the tip as shown in Figure 42B. The flexible seal is made of a material that has a coefficient of friction that reduces the tendency of the skin that is in contact with it, to slip. The seal should be sufficiently flexible so that it can be moved between a first position and the second position and sufficiently rigid to keep the skin in a stationary position. The opening 3030 in the flexible seal has an area greater than the area of the opening 3032 in the lower base 3028 of the tip 3022, when the flexible seal is in the first position, as shown in Figure 42A. In operation, the flexible seal is placed against the patient's "S" skin. The area of the skin that is in contact with the flexible seal is greater than the area of the opening in the lower base of the tip. Consequently, the volume of the skin raised inside the tip is greater than the volume of the skin that would be lifted at the tip with a flat seal. In this way, the flexible seal would be beneficial for a patient who had a skin flexibility below normal. 8 volunteers were examined in the dorsal forearm substantially in the manner described above. In the previous examples, the tip assembly was manipulated by moving it from side to side or towards and away from the skin. In this example, the tip assembly did not move after it was placed against the skin. Each volunteer was examined 8 times using the flat seal and flexible seal configurations for a total of 16 tests per volunteer. The time to fill the detector after the puncture was recorded. The detector was considered to be full when a current of 1.5μA was generated. The vacuum was released then. The average time required for the current to reach 1.5μA for the flexible seal was 14.9 seconds and the average time required for the current to reach 1.5μA for the flat seal was 17.9 seconds. The tip that employs the flexible seal requires less time to fill the detector than does the tip that employs the flat seal, furthermore, manipulation of the tip assembly was eliminated. EXAMPLE 18 This example demonstrates that the device shown in Figures 44A and 44B can be used successfully to obtain blood in amounts sufficient for analysis in an acceptably short amount of time. The blood collection device shown in Figures 44A and 44B was filled with a "Becton-Dickinson ULTRA-FINE" lancet into a pneumatic lancet assembly of the type illustrated in Figures 11-19. The blood collection device was also fitted with a glucose detector that had a diameter of 2. Omm covered with a mesh in an opening. 29 human volunteers were used in this example, holding the dorsal forearm of each volunteer to two separate extraction procedures. For each procedure, the blood collection device was placed against the volunteer's forearm and, after exposing to a vacuum of approximately -7.5psig for approximately 5 seconds, each individual had their forearm (dorsal forearm) pricked. After perforation, the blood was collected, and when a sufficient amount of blood has been collected, the vacuum was released and the blood collection device was removed from the individual's skin. This process repeated a total of 2 times for each individual. Before each extraction, a new lancet and glucose detector was adjusted in the blood collection device. Time was recorded for the glucose detector to collect enough blood to perform an analysis. It was considered that the glucose detector had collected enough blood when a current of 1.5μA was generated. The results of the blood collection are presented in Figure 47. The data represented graphically in Figure 47 are shown for each volunteer in TABLE XI.

TABLE XI The data shown in Figure 47 show that, for more than 35% of the punctures, enough blood was collected within 5 seconds to perform an analysis. With the exception of one glucose detector that did not work (volunteer 25, test 2), for approximately 95% of the punctures, the glucose detectors collected enough blood in 40 seconds less for the analysis. For the remaining punctures, the tests were stopped after 40 seconds. With respect to punctures for which sufficient blood was collected in 40 seconds or less, the average time to collect enough blood was 8.2 seconds.

EXAMPLE 19 This example demonstrates that the device shown in Figures 43A, up to 43C can be used successfully to obtain blood in amounts sufficient for analysis in an acceptably short amount of time. The blood collection device shown in Figures 44A and 44B was filled with a "Becton-Dickinson ULTRA-FINE" lancet into a pneumatic lancet assembly of the type illustrated in Figures 11-19. The blood collection device was also fitted with a glucose detector that had a diameter of 2. Omm covered with a mesh in an opening. 15 human volunteers were used in this example, holding the dorsal forearm of each volunteer to two separate extraction procedures. For each procedure, the blood collection device was placed against the volunteer's forearm and, after exposing to a vacuum of approximately -7.5psig for approximately 5 seconds, each individual had their forearm (dorsal forearm) pricked. After perforation, the blood was collected, and when a sufficient amount of blood has been collected, the vacuum was released and the blood collection device was removed from the individual's skin. This process was repeated a total of 4 times for each individual. Before each extraction, a new lancet and glucose detector was fitted to the blood collection device. Time was recorded for the glucose detector to collect enough blood to perform an analysis. It was considered that the glucose detector had collected enough blood when a current of 1.5μA was generated. The results of the blood collection are presented in Figure 48. The data shown in Figure 48 show that, for approximately 45% of the punctures, enough blood was collected within 5 seconds to perform an analysis. For approximately 97% of the punctures, the glucose detectors collected enough blood in 40seconds or less for analysis. For the remaining punctures, the tests were stopped after 40 seconds. With respect to punctures for which enough blood was collected in 40seconds or less, the average time to collect enough blood was 7.0seconds. EXAMPLE 20 This example demonstrates that the device shown in Figures 45A through 45C can be successfully used to obtain blood in amounts sufficient for analysis in an acceptably short amount of time. The blood collection device shown in Figures 45A through 45E was fitted with a "BD ULTRA-FINE" lancet into a pneumatic lancet assembly of the type illustrated in Figures 11-19. The blood collection device was also fitted with a glucose detector having a diameter of 2. Omm of semicircular notch covered with a mesh at one end of the detector. 29 human volunteers were used in this example, holding the dorsal forearm of each volunteer to two separate extraction procedures. For each procedure, the collection device was placed against the volunteer's forearm and, after exposing to a vacuum of approximately -7.5psig for approximately 5 seconds, each individual had their forearm (dorsal forearm) pricked. 50 milliseconds after the lancet was fired, the mobile projection was triggered and the glucose detector moved closer to the perforated opening in the individual's skin. After perforation, the blood was collected, and when a sufficient amount of blood has been collected, the vacuum was released and the blood collection device was removed from the individual's skin. This process repeated a total of 2 times for each individual. Before each extraction, a new lancet and glucose detector was fitted to the blood collection device. Time was recorded for the glucose detector to collect enough blood to perform an analysis. It was considered that the glucose detector had collected enough blood when a current of 1.5μA was generated. The results of the blood collection are presented in Figure 49. The data shown in Figure 49 show that for more than 45% of the punctures, enough blood was collected within 5 seconds to perform an analysis. Two of the glucose detectors did not exceed the 1.5μA trigger current due to hardware or software problems. Two of the glucose detectors did not move due to an unknown problem and did not make contact with the skin. Excluding these 4 punctures, for 91% of the remaining punctures, the glucose detectors collected enough blood in 40seconds or less for the analysis. For the remaining punctures, the test was stopped after 40 seconds. With respect to punctures for which sufficient blood was collected in 40seconds or less, the average time to collect blood was 6.8 seconds. Various modifications and alterations of this invention will be apparent to those skilled in the art without departing from the scope and spirit of this invention and it should be understood that this invention is in no way limited to the illustrated embodiments presented therein.

Claims (136)

1. CLAIMS 1. A method for obtaining a blood sample for a diagnostic test, the method comprising the steps of: (a) forming an unobstructed opening in an area of the skin from which the sample is to be extracted; (b) extract the sample from the unobstructed opening in the area of the skin with the help of vacuum and skin stretch.
2. 2. The method of claim 1, wherein the diagnostic test is a test for terminating the blood glucose concentration.
3. The method of claim 1, further comprising the step of increasing the availability of blood to the area of the skin from which the sample is to be extracted before forming the opening in the area of the skin from which it is going to extract the sample.
4. The method of claim 3, wherein a vacuum is used to increase the blood supply of the skin from which the sample is to be extracted before forming the opening in the area of the skin from which it is going to extract the sample.
5. The method of claim 4, wherein stretching is used to increase the blood supply of the skin from which the sample is to be extracted before forming the opening in the area of the skin from which it is to be extracted. the sample.
6. The method of claim 3, wherein heat is used to increase the blood supply of the skin from which the sample is to be extracted before forming the opening in the area of the skin from which it is to be extracted. the sample.
7. The method of claim 6, wherein heat is used to increase the blood supply of the skin from which the sample is to be extracted before forming the opening in the area of the skin from which it is to be extracted. the sample.
8. The method of claim 1, wherein the opening in the area of the skin from which the sample is to be extracted is formed by a lancet.
9. The method of claim 8, wherein the lancet is mounted by means of a vacuum.
10. The method of claim 8, wherein the lancet is triggered by a vacuum.
11. The method of claim 1, wherein the extracted sample is analyzed by means of a glucose detector.
12. The method of claim 11, wherein the glucose detector employs a reflectometer.
13. 13. The method of claim 11, wherein the glucose detector employs a biosensor.
14. The method of claim 8, wherein the lancet penetrates the skin to a depth no greater than 1.6mm.
15. The method of claim 1, wherein the opening in the area of the skin from which the sample is to be extracted is formed by a laser.
16. The method of claim 1, wherein the opening in the area of the skin from which the sample is to be extracted is formed by a fluid jet.
17. 17. The method of claim 1, wherein the blood is obtained from the forearm.
18. 18. The method of claim 1, wherein the blood is obtained at a lower pain level than that experienced when a finger is pierced by a standard finger lancet.
19. 19. An apparatus for conveniently obtaining a sample of body fluid for analysis in a diagnostic test, the apparatus comprising: (a) a device for forming an unobstructed opening in an area of the skin, from which it is to be extracted the sample, and (b) a vacuum pump to extract the sample from the unobstructed opening in the area of the skin.
20. 20. The apparatus of claim 19, further including a housing.
21. The apparatus of claim 19, wherein the device for forming the unobstructed opening comprises a lancet disposed in a puncture assembly.
22. 22. The apparatus of claim 21, wherein the puncture assembly comprises a tip having a seal, which can be formed as a vacuum or through the puncture assembly by the vacuum pump.
23. 23. The apparatus of claim 19, wherein the lancet is capable of retracting after it forms the unobstructed opening in the skin.
24. 24. The apparatus of claim 19, wherein the device for forming the unobstructed opening is a laser.
25. 25. The apparatus of claim 19, wherein the device for forming the unobstructed opening is a non-fluid jet.
26. 26. The apparatus of claim 19, further comprising a heating element.
27. 27. The apparatus of claim 19, further comprising a glucose detector.
28. 28. The apparatus of claim 27, wherein the glucose detector is a biosensor.
29. 29. The apparatus of claim 27, wherein the glucose detector is a reflectometer.
30. 30. The apparatus of claim 30, wherein the vacuum is applied by an apparatus having a larger dimension ranging from about 2mm to about 10mm.
31. 31. An assembly capable of providing an opening in the skin of a patient by a lancet, comprising: (a) a fastener for holding a lancet assembly; (b) an element for providing sufficient force to cause the fastener to be held in a position whereby a lancet in that fastener would be placed away from the patient's skin; and (c) an element for allowing a gas to provide sufficient force to overcome the force provided by the fastener holding member by which the gas causes the fastener to move to a position by means of which the lancet in the Bra would be available to pierce the patient's skin.
32. 32. The assembly of claim 31 further includes a lancet assembly in the fastener.
33. 33. The assembly of claim 31, wherein the movement of the fastener is carried approximately by means of the gas acting on a piston attached to the fastener.
34. 34. The assembly of claim 33, wherein the element holding the fastener (b) is a piston diverter element.
35. 35. The assembly of claim 34, wherein the piston diverter is a spring.
36. 36. The assembly of claim 34, wherein the piston diverter is a bellows.
37. 37. The assembly of claim 31, wherein the element (c) comprises a piston attached to the fastener, the piston being disposed in a recess, the recess being capable of being open to allow sufficient gas at sufficient pressure to move the piston. piston, whereby the holder is moved to the position by which a lancet in the holder would be able to pierce the patient's skin.
38. 38. The assembly of claim 37, wherein the element (c) comprises a valve having a first port, a second port, and a third port, the first port capable of communicating with a gas source at a first pressure, the second port capable of communicating with the gap, the third port capable of communicating with a gas source at a second pressure, the second pressure being less than the first pressure.
39. 39. The assembly of claim 37, further including an element for sealing the gap.
40. 40. The assembly of claim 39, wherein the sealing element in an O-ring.
41. 41. The assembly of claim 39, wherein the sealing element is a bellows.
42. 42. The assembly of claim 39, wherein the sealing element is a diaphragm.
43. 43. The assembly of claim 31, which also includes a piston, attached to the holder, the piston (1) travels to a first division in the gap when the gas at a first pressure enters the hole and the first pressure exceeds the pressure of the gas in the hollow before the gas enters the first pressure and (2) travels a second direction in the hollow when the element that holds the fastener (b) exceeds the force of the gas acting on the piston in that hollow.
44. 44. An assembly capable of supporting a lancet assembly to provide an opening in the skin of a patient, comprising: (a) a housing having a recess having an axis; a valve adjusted in a valve manifold; a first portion in the valve manifold that allows the valve manifold to allow gas to pass through at a first pressure through a first port in the valve. A second port in the valve manifold that allows the valve manifold to allow the gas to pass through the pressure of the gas through a second port in the valve to enter the well; A third port in the valve manifold that allows the valve manifold to allow the passage of the hollow gas through a third port in the valve to a place having gas at the second pressure, the first pressure being greater than the second pressure; (b) A piston disposed in the hollow, the piston having a proximal end and a distal end, the proximal end adjacent to the second port and the distal end including a fastener for holding a lancet, the piston capable of moving along the hollow axis. (c) An element for deflecting the piston so that the proximal end is in the position farthest from the skin of the patient when the first port is closed.
45. 45. The assembly of claim 44, wherein the piston deflection member (c) is a spring.
46. 46. The assembly of claim 44, wherein the ram diversion member (c) is a bellows.
47. 47. The assembly of claim 44, wherein the valve is activated by a solenoid.
48. 48. The assembly of claim 44, further including an element for sealing the gap.
49. 49. The assembly of claim 48, wherein the element for sealing the gap is an O-ring.
50. The assembly of claim 48, wherein the element for sealing the gap is a bellows.
51. 51. The assembly of claim 48, wherein the element for sealing the gap is a diaphragm.
52. 52. A method for forming an opening in the skin of a patient, for the purpose of obtaining blood, the method comprises the steps of: (1) providing a puncture assembly capable of providing an opening in a patient's skin by means of of a lancet, comprising: (a) a fastener for holding a lancet assembly; (b) an element for providing sufficient force to cause the fastener to be held in a position whereby a lancet in the fastener would be placed away from the patient's skin; (c) an element to allow a gas to provide sufficient force to overcome the force provided by the fastener holding member, whereby the gas causes the fastener to move to a position whereby a lancet in the fastener would be capable of to pierce the patient's skin; (d) an assembly of the puncture in the fastener, (2) placing the puncture assembly sufficiently close to the patient's skin so that a lancet in the lancet assembly can pierce the patient's skin; (3) causing element (c) to allow a gas to provide sufficient force to overcome the force provided by the gas holding member so that the fastener moves to a position whereby the lancet in the lancet assembly pierces the skin of the patient; (4) cause the lancet to retract from the patient's skin.
53. 53. A multi-layered element comprising: (a) a layer capable of receiving blood and transporting the received blood by means of chemically aided capillary action; (b) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (c) a layer that can be brought into contact with a meter, the layer that can be brought into contact with the meter is superimposed on the layer that carries blood, layer (a) capable of transporting blood to layer (b) .
54. 54. The article of claim 53, wherein the layer carrying blood comprises a mesh.
55. 55. The article of claim 53, wherein the layer carrying blood comprises a surfactant. t
56. 56. The article of claim 53, wherein the layer carrying blood has at least one opening therein.
57. 57. The article of claim 53, wherein the analyte detecting layer detects the analyte by means of an electrical measurement.
58. 58. The article of claim 53, wherein the analyte detecting layer detects the analyte by means of an optical measurement.
59. 59. The article of claim 53, wherein no more than two microliters of blood are required for the analyte determination.
60. 60. The article of claim 53, wherein not more than one microliter of blood is required for the determination of the analyte.
61. 61. The article of claim 53, wherein a coating layer is covered around the periphery of the layer that carries blood.
62. 62. The article of claim 53, wherein the layer that can be brought into contact with the meter has at least one opening.
63. 63. The article of claim 62, wherein the layer carrying blood at least partially overlaps the at least one opening.
64. 64. The article of claim 62, wherein the layer carrying blood does not overlie the at least one opening.
65. 65. The article of claim 62, wherein the layer that can be brought into contact with the meter has at least two openings.
66. 66 An article of capable manifolds comprising: (a) a cover layer having an opening therein; (b) a layer, superimposed on the cover layer, capable of receiving blood through the opening in the cover layer and transporting blood by means of chemically assisted capillarity; (c) a layer that can be brought into contact with a meter, the layer that can be brought into contact with the meter superimposed on the blood transport layer; and (d) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood, this layer is disposed between the cover layer and the layer that can be brought into contact with the meter and is capable of receiving blood from the analyte. the layer that carries blood.
67. 67. The article of claim 66, wherein the layer that carries blood is a mesh.
68. 68. The article of claim 66, wherein the layer carrying blood comprises a surfactant.
69. 69. The article of claim 66, wherein the layer carrying blood has at least one opening therein.
70. 70. The article of claim 66, wherein the analyte detecting layer detects analyte by means of an electrical measurement.
71. 71. The article of claim 66, wherein the analyte detecting layer detects analyte by means of an optical measurement.
72. 72. The article of claim 66, wherein no more than 2 microliters of blood are required for the determination of the analyte.
73. 73. The article of claim 66, wherein no more than 1 microliter of blood is required for the analyte determination.
74. 74. The article of claim 66, wherein the cover layer is covered around the periphery of the blood transport layer.
75. 75. The article of claim 66, wherein the layer that can be brought into contact with the meter has at least one opening therein.
76. 76. The article of claim 75, wherein the layer that carries blood at least partially is superimposed on the at least one opening.
77. 77. The article of claim 75, wherein the layer carrying blood is not superimposed on the at least one opening.
78. 78. The article of claim 75, wherein the layer that can be brought into contact with the meter has at least two openings therein.
79. 79. A multi-layer article comprising: (a) a cover layer; (b) a layer, superimposed on the cover layer, which can be brought into contact with a meter; and (c) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood, this layer is disposed between the cover layer and the layer that can be brought into contact with the meter and is capable of receiving blood by capillary blood flow medium between the cover layer and the layer that can be brought into contact with the meter, wherein the cover layer and the layer that can be brought into contact with the meter are separated at a sufficient distance so that capillarity forms between them.
80. 80. The article of claim 79, wherein a jacket layer separates the cover layer and the layer that can be brought into contact with the meter at a sufficient distance such that a capillarity is formed between the cover layer and the cover layer. layer that can be put in contact with the meter.
81. 81. The article of claim 79, wherein the analyte detection layer detects analyte by means of an electrical measurement.
82. 82. The article of claim 79, wherein the analyte detection layer detects analyte by means of an optical measurement.
83. 83. The article of claim 79, wherein no more than two microliters are required for the analyte determination.
84. 84. The article of claim 79, wherein not more than one microliter of blood is required for the analyte determination.
85. 85. The article of claim 79, wherein the layer that can be brought into contact with the meter has at least one opening therein.
86. 86. The article of claim 79, wherein the cover layer has an opening therein.
87. 87. A method for performing a diagnostic test using a blood test, the method comprising the steps of: (a) forming an unobstructed opening in an area of the skin from which the blood is to be drawn; (b) extract the blood from the unobstructed opening in the area of the skin, with the help of vacuum and stretching of the skin; (c) providing a multi-layered article comprising: (d) allowing the extracted sample to be received by the layer that carries blood and allowing the blood to be transported by means of capillarity chemically aided to the layer capable of detecting the presence of analyte or measure the amount of analyte in the blood; and (e) determining the presence of the analyte or measuring the amount of analyte in blood.
88. 88. The method of claim 87, wherein no more than two microliters of blood is required for the analyte determination.
89. 89. The method of claim 87, wherein not more than one microliter of blood is required for the analyte determination.
90. 90. A method for performing a diagnostic test using a blood sample, the method comprising the steps of: (a) forming an unobstructed opening in an area of the skin from which the blood is to be drawn; (b) extract the sample from the unobstructed opening in the area of the skin, with the help of vacuum and skin stretch; (c) providing a multi-layer article comprising: (i) a cover layer having an opening therein; (ii) a layer, superimposed on the cover layer, capable of receiving blood through the opening in the cover layer and transporting blood by means of the chemically aided capillarity; (iii) a layer that can be brought into contact with a meter, the layer that can be brought into contact with the meter superimposed on the layer that carries blood; and (iv) a layer capable of detecting the presence of the analyte or measuring the amount of analyte in blood, this layer is disposed between the cover layer and the layer that can be brought into contact with the meter and is capable of receiving blood from the layer that carries blood. (d) allowing the extracted sample to be received by the blood transport layer and allowing the blood to be transported by means of capillarity chemically aided to the layer capable of detecting the presence of analyte or measuring the amount of analyte in the blood; and (e) determining the presence of analyte or measuring the amount of analyte in blood.
91. 91. The method of claim 90, wherein no more than two microliters of blood is required for analyte determination.
92. 92. The method of claim 90, wherein not more than one microliter of blood is required for analyte determination.
93. 93. A method for performing a diagnostic test using a blood sample, the method comprising the steps of: (a) forming an unobstructed opening in the area of the skin from which blood will be drawn; (b) extract the sample from the unobstructed opening in the area of the skin, with the help of vacuum and skin stretch; (c) providing a multi-layer article comprising: (i) a cover stage; (ii) a layer, superimposed on the cover layer that can be brought into contact with a meter; and (iii) a layer capable of detecting the presence of analyte or measuring the amount of analyte in blood, this layer is disposed between the cover layer and the layer that can be brought into contact with the meter and is capable of receiving blood by means of capillary blood flow between the cover layer and the layer that can be brought into contact with the meter, wherein the cover layer and the layer that can be brought into contact with the meter are spaced a sufficient distance so that Capillarity forms between them; (d) allowing the extracted sample to be transported by means of capillary flow to the layer capable of detecting the presence of analyte or measuring the amount of analyte in blood; and (e) determining the presence of analyte or measuring the amount of analyte in blood.
94. 94. The method of claim 93, wherein no more than two microliters of blood are required for analyte determination.
95. 95. The method of claim 93, wherein not more than one microliter of blood is required for analyte determination.
96. 96. A convenient tip for use with a blood collection apparatus, the tip comprising: (a) a lower base having an opening therein; (b) a top base having an opening therein; (c) an inner wall joining the upper base and the lower base, the area of the opening in the upper base being equal to or less than the area of the opening in the lower base.
97. 97. The tip of claim 96, further including at least one passage for vacuum.
98. 98. The tip of claim 96, wherein the opening of the upper base is circular in shape.
99. 99 The tip of claim 96, wherein the opening in the upper base is oval in shape.
100. 100. The tip of claim 96, wherein the inner wall is decreased.
101. 101. The tip of claim 96, wherein the inner wall is composed of stepped cylindrical sections.
102. 102. The tip of claim 96, wherein the opening in the upper base is surrounded by a ring.
103. 103. The tip of claim 96, further including a seal attached to the lower base of the tip.
104. 104. The tip of claim 103, wherein the seal has the shape of an annulled ring.
105. 105. The tip of claim 103, wherein the seal is capable of moving between a first position and a second position.
106. 106. The tip of claim 103, wherein the seal is formed of rubber or an elastomeric material.
107. 107. The tip of claim 103, wherein the seal is formed of an adhesive.
108. 108. A convenient apparatus for obtaining a blood sample for analysis in a diagnostic test, comprising: (a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with the sealable chamber, ( b) a source of energy; (c) a vacuum pump operatively connected to the energy source, the vacuum pump in communication with the sealable chamber, (d) a puncture assembly positioned in the housing, the puncture assembly capable of moving a lancet toward the opening sealable, and (e) a fluid collector placed in the sealable chamber, the fluid collector in fluid communication with the sealable opening.
109. 109. The apparatus of claim 108, wherein the housing comprises: (a) a body portion, (b) a door portion, the door portion movable on the body portion and including the sealable opening.
110. 110. The apparatus of claim 109, wherein the fluid collector is placed in a slot in the door portion.
111. 111. The apparatus of claim 110, wherein the slot locates the fluid collector adjacent to the sealable opening when the door portion is placed on the body portion.
112. 112. The apparatus of claim 109, wherein the body portion contains at least one slot for inserting the fluid collector.
113. 113. The apparatus of claim 109, wherein the body portion includes at least one electrical connection.
114. 114. The apparatus of claim 109, wherein the door portion includes at least one electrical connection.
115. 115. The apparatus of claim 109, wherein the body portion comprises a movable projection comprising a groove, the fluid manifold positioned in the groove.
116. 116. The apparatus of claim 115, wherein the movable projection includes at least one electrical connection.
117. 117. The apparatus of claim 108, wherein the housing comprises: (a) a body portion, (b) a lower cover portion movable on the puncture assembly, and (c) a door portion movable on the portion of lower cover and including the sealable opening.
118. 118. The apparatus of claim 117, wherein the inner cover portion comprises at least one alignment channel for positioning the fluid collector.
119. 119. The apparatus of claim 117, wherein the door portion contains at least one alignment fitting for positioning the fluid collector.
120. 120. The apparatus of claim 117, wherein the housing further comprises a projection.
121. 121. The apparatus of claim 120, wherein the fluid collector is positioned in at least one slot in the projection.
122. 122. The apparatus of claim 121, wherein the at least one groove is parallel to the upper surface of the inner cover.
123. 123. The apparatus of claim 121, wherein the at least one slot is not parallel to the upper surface of the inner cover.
124. 124. The apparatus of claim 121, wherein claim 121, wherein the projection includes at least one electrical connection.
125. 125. The apparatus of claim 108, further comprising a heating element.
126. 126. The apparatus of claim 108, wherein the fluid collector comprises a biosensor.
127. 127. The apparatus of claim 126, wherein the biosensor comprises a reflectance strip.
128. 128. The apparatus of claim 108, wherein the
129. 129. The apparatus of claim 128, wherein the reflectance strip comprises a glucose detector.
130. 130. The apparatus of claim 108, further comprising a reflectometer.
131. 131. The apparatus of claim 108, further comprising a visual display operatively connected to the energy source and the fluid collector.
132. 132. The apparatus of claim 108, comprises a switch operatively connected to the vacuum pump and the puncture assembly through the power source.
133. 133. The apparatus of claim 108, comprises electronics.
134. 134. The apparatus of claim 133, wherein the electronics control the energy of the vacuum pump.
135. 135. The apparatus of claim 133, wherein the electronics control the energy of a heating element.
136. 136. The apparatus of claim 133, wherein the electronics control the energy of the lancing element.