MXPA97002122A - Lanceta desecha - Google Patents

Abstract

The present invention relates to a single-use disposable lancet device comprising: a spring mechanism mounted on a pivot in the housing, the spring mechanism comprising a sharp end, wherein the spring mechanism is mounted within the housing in a substantially unpolarized state, and an accord to polarize the spring mechanism, the actuator being movable, with respect to the housing, from an initial position to a polarization position to a working position, in that order; the actuator including a device lock which engages the spring mechanism to prevent the actuator from moving from the locked position, the housing including an aperture of specified size to allow the sharpened end to protrude through thereinly from the housing in the biasing of the spring mechanism sharpening shrinks back inside the housing in the locked position; The spring mechanism and the sharpened end being mounted within the housing in the sub-substantially non-polarized state the actuator is in the starting position, the spring mechanism being porlarized by the actuator being in the polarized position, causing the sharpened end to protrude from the housing and the spring mechanism returning to a state of substantially non-polarized when the actuator is in the locked position

Description

DISPOSABLE LANCET BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to a lancet device which is suitable for a single use only and which can not be effectively used after a single use. The device also includes indicators by which a user can easily and visibly determine whether the device has been used or not. 2. Description of Background Information Pointed lancets or sheets are often used to make a small penetration into a patient's skin in order to remove a small volume of blood for diagnostic purposes. With the growing concern of communicable diseases transmitted by blood such as AIDS, hepatitis, etc., it is increasingly critical to ensure that a needle or lancet, once used, is not used again in a different patient. Therefore, precautions should be taken to ensure that once used, a lancet can not be accidentally used again. In addition, because of the continuing threat that a lancet poses even after discarding it, it is important that the lancet tip be fully and safely protected after use and disposal, to avoid accidental contact with hygiene workers or anyone else that could accidentally contact the device. Spring-loaded lancets, ie, preloaded spring-loaded lancets of many types have been known and used as a needle replacement to penetrate the skin for blood samples. Some of these devices are designed as single-use disposable devices. However, the relative complexity of these devices has made their manufacture expensive, often unreliable to use. For example, the preloaded spring can often cause the tip of the lancet to fail or the spring to twist making an unacceptable incision or an incision that transmits more pain to the patient than absolutely necessary. In U.S. Patent No. 5,356,420 discloses a preloaded device in which a piercing tip 7 is placed on a piston inside a piston sleeve 1. A motor spring 9 is preloaded into the sleeve and actuated by pressing a button 2. An additional spring 10 is provided to ensure that the piercing tip 7 is contracted in the sleeve after use. Simpler disposable lancet devices that do not employ preloaded spring drive have also been developed. For example, U.S. Patent No. 4,889,117 discloses a disposable lancet (Figs 7 and 8) in which a 48 'needle tip is provided within a tube 50. A plug 44 is provided at one end for the tube 50. By pressing plug 44, tip 48 * protrudes from tube 50 and penetrates the patient's skin. A washer 60 formed of elastic steel is provided to ensure that the tip is retracted back into the tube 50 when force is no longer applied to the plug 44. An internally polarized tab 62 prevents the lancet from being reused after the first use. However, with this type of device, when a driving force applied to the plug is in the direction of the patient's skin, when the operator operates the device, the force applied for the operation can apply excessive force to the skin, which It can result in unnecessary tissue damage. U.S. Patent Nos. 5,133,730 and 5,212,879 disclose a contractile finger pricking device, disposable and method for manufacturing the same. Within a housing 12, a blade 14 is provided. A lever arm 16 protrudes from the housing 12. Upon lowering the lever arm 16, the lever arm moves a biasing member 60 to adjust a ramp 52 in order to protrude more beyond the housing 12 and penetrate the patient's skin. The polarization member 60 is locked against the ramp of the blade holder 50 after a single use, to thereby prevent the device from being used again. The blade and the blade holder are placed on a functioning hinge 48 which helps to contract the blade back into the housing after use. This device has a relatively large number of moving parts and a relatively complex arrangement, thereby increasing its production cost. With respect to the device disclosed in the Patents US Numbers 5,133,730 and 5,212,879, as well as the device disclosed in U.S. Patent No. 4,889,117, an operator can not easily determine, by viewing the device, whether or not it has been used. Therefore, although an operator would not be able to accidentally puncture a second patient with one of these lancets after it has already been used, there is still a real risk with the use of these devices. Because the operator can not visually determine if the lancet has been used, there is a possibility that the operator assumes that a used device has not been used. In this case, the operator will not be able to actually puncture another patient. However, the operator may touch the skin of a second patient with the housing in the place where the blade has the purpose of protruding during the puncture. Since in this example the lancet had already been used, there is a possibility that the housing will be contaminated at this location with blood or other infectious contaminants. Therefore, there is a real risk that these contaminants could be transferred to the second patient simply by having contact with the housing of the lancet device used with the skin of the second patient. In this way, there is a need for an automatic, simple, inexpensive and reliable lancet device which clearly indicates whether the device has been used or not. COMPENDIUM OF THE INVENTION An advantage of the present invention is the provision of a disposable lancet device which is composed of a minimum number of parts that are not expensive to manufacture and are easy to assemble. Another advantage of the present invention is the provision of an indicator which assumes two distinct positions, which are clearly recognizable and distinguishable to the casual observer. One position indicates that the lancet device has not yet been used and the other position indicates that the device has been used and should be discarded. Another object of the present invention is to provide an ergonomically comfortable housing for a lancet device, which an operator can easily handle with one hand and in which absolutely only two fingers are required for operation. A further objective of the present invention is to provide a disposable lancet device, in which the sharp tip of the device is exposed from the housing only very momentarily, during the actual puncture process and at all other times is safely covered by the accommodation. Other objects and advantages of the present invention and their useful features will be apparent as the description runs its course in the present. Included in the description is a disposable disposable lancet device comprising a housing and a spring mechanism pivotally mounted in the housing. The spring mechanism includes a sharp end. The spring mechanism is mounted within the housing in a substantially unpolarized state before use. An actuator for biasing the spring mechanism can be moved, with respect to the housing, from an initial position to a polarization position to a locked position, in that order. The actuator includes a locking device which engages the spring mechanism to prevent movement of the actuator from the locked position. The housing includes an aperture of specified size to allow the sharpened end to protrude therethrough outwardly of the housing in the bias of the spring mechanism and the sharpened end is retracted back into the housing when in the locked position. The spring mechanism is mounted within the housing in a substantially unpolarized state when the actuator is in the initial position. The spring mechanism is polarized by the actuator when it is in the polarized position, causing that the sharp end protrudes from the housing. The spring mechanism returns to a state of substantially unpolarized when the actuator is in the locked position. A pivot post is mounted inside the housing. The spring mechanism is pivotally mounted around the pivot post and is pivotally polarized with respect to the pivot post in the polarization by the actuator. A stop is mounted inside the housing. A second end of the spring mechanism, which is the end opposite the sharp end, ends at the stop and its movement is stopped in a predetermined direction by the stop during the biasing of the spring mechanism. The housing includes two face components joined by a peripheral surface to form a compartment within. In a preferred embodiment, the actuator is mounted substantially in the center of one of the face components of the housing. In another preferred embodiment, the actuator is mounted through the peripheral surface of the housing. Preferably, the housing is substantially disk-shaped with the two face components comprising two substantially circular faces and the peripheral surface joining the circular faces along the circumferential shoulders. However, other forms can also be used. The actuator preferably includes a button operable by one or more fingers of a user, an axis extending from the button and extending into the housing and a bias portion to touch and bias the spring mechanism in the movement of the actuator from the initial position to the polarization position. The button visibly extends from the housing when it is in the initial position, so that an operator can easily see that the device has not yet been used. The polarization portion of the actuator, in one embodiment, includes a flap with ramp extending from the axis for progressive polarization of the spring mechanism while the button is pushed closer to the housing, from the initial position to the polarization position. In this embodiment, the locking device includes a notch formed between one end of the flap with ramp, the axis and the button. By fully pushing the button to rest on the housing, the spring mechanism slides from the flap with ramp and into the notch, thereby returning to a condition of substantially unpolarized and preventing the actuator from returning to the initial position. Therefore, when the actuator is in the initial position, a user can easily visually identify the initial position by the space of the button from the surface of the housing and know that the lancet device has already to be used. On the other hand, when the actuator is in the locked position, a user can easily visually identify the locked position by the position of the button resting on the surface of the housing and know that the lancet device has been used and should be discarded. The actuator further includes a flange extending from one end of the shaft opposite an end of the shaft that is connected to the button and extends therefrom. The flange abuts the spring mechanism in the initial position and prevents the actuator from being removed from the housing. In another embodiment, the polarization portion of the actuator includes a cone at one end of the shaft opposite an end of the shaft extending from the button and a rectangular portion of the shaft extending from the cone for progressive polarization of the spring mechanism while the button is pushed closer to the housing, from the initial position to the polarization position. In this embodiment, the locking device includes a notch formed in the axis, between the rectangular part and the end of the shaft extending from the button. By fully pushing the button to rest on the housing, the spring mechanism slides from the rectangular part of the shaft and the notch, thereby returning to a substantially unpolarized condition and preventing the actuator from returning to the initial position. Therefore, when in the initial position, a user can visually identify the initial position with ease by the space between the button and the surface of the housing and know that the lancet device has already to be used. On the other hand, when the actuator is in the locked position, a user can easily visually identify the locked position by the contact between the button and the surface of the housing and know that the lancet device has been used and should be discarded. In this embodiment, the actuator further includes a flange extending from the axis between the notch and the end of the shaft extending from the button. The flange abuts the inner surface of the housing when the actuator is in the initial position and prevents the actuator from being removed from the housing. However in another embodiment, the locking device includes a keyway formed through the shaft, between the rectangular portion of the shaft and the shaft end extending from the button. By fully pushing the button to rest on the housing, the spring mechanism slides from the rectangular portion and into the keyway, thereby returning to a substantially unpolarized condition and preventing the actuator from returning to the initial position. . Therefore, when the actuator is in the initial position, a user can visually identify the initial position easily by the space between the button and the surface of the housing and know that the lancet device has already to be used. On the other hand, when the actuator is in the locked position, a user can easily visually identify the locked position by the contact between the button and the surface of the housing and know that the lancet device has been used and should be discarded. In this embodiment, the actuator further includes a flange extending from the shaft between the keyway and the end of the shaft extending from the button. The flange abuts the inner surface of the housing when the actuator is in the initial position and prevents the actuator from being removed from the housing. Furthermore, a single-use disposable lancet device is disclosed which includes a housing, a spring mechanism mounted in the housing, an actuator for biasing the spring mechanism, means for indicating that the lancet device has not been used and means for indicate that the lancet device has been used. The spring mechanism has a sharp end and is mounted within the housing in a substantially unpolarized state.

The actuator can be moved, with respect to the housing, to bias the spring mechanism in order to extend the sharpened end so that it protrudes from the housing. The device further includes a means for preventing the lancet device from being used again after having been used only once. The actuator includes a button operable by one or more fingers of a user, an axis extending from the button and extending into the housing and a polarization portion for touching and biasing the spring mechanism in movement of the button towards the housing, from the position initial to the polarization position. Preferably, the means for indicating that the lancet device has not been used includes a position of the button with respect to the housing wherein the button visibly extends from the housing to show that the lancet device has not been used. Preferably, the means for indicating that the lancet device has been used includes a position of the button with respect to the housing wherein the button visibly touches the housing to show that the lancet device has been used. Preferably, the means for preventing the lancet device from being used again after being used only once includes a locking mechanism that locks the button in the position where the button touches the housing, thereby preventing the button from contracting and preventing the actuator from polarizing the spring mechanism more than once. The button can be constructed and arranged in different ways and can have different forms. For example, the button may have an elongated means at its top that touches or substantially touches the housing in the locked position. Alternatively, the button may comprise a cylindrical shaft having an upper part that is substantially flush with the surface of the housing in the locked position. At least the upper part of the cylindrical shaft may be of a different color than the housing to allow easy viewing of the button in its unused outgoing position and in its used locked position. In addition, the button may include an element in it that holds the button in the initial position. For example, there may be a protrusion on the button axis that prevents the button from being pressed into the housing to a point where it would cause the needle to protrude from the housing. Therefore, the button axis may include a fragile protrusion in it that would require its removal before using the device. Alternatively, an orifice may be included in the shaft through which a removable C-shaped staple or a removable tubular member may be inserted to prevent premature activation of the device. BRIEF DESCRIPTION OF THE DRAWINGS The present invention is further explained in the following description with reference to the drawings, illustrating, by way of non-limiting examples, various embodiments of the invention, with like reference numbers representing similar parts in all views and where: FIG. 1 is a perspective view showing the use of a first embodiment of the present invention in a puncture operation of a patient's finger; Fig. 2 is a plan view of the first embodiment, showing contact with a cross section of a patient's finger; Fig. 3 is a side view of the first embodiment showing the actuator in an initial position; Figs. 3a and 3b illustrate an alternative construction of the button; Fig. 4 is a side view of the first embodiment showing the actuator in a used and locked position; Fig. 5 is a sectional view taken halfway around the perimeter of the device according to the first embodiment; Fig. 6 is a side view of the actuator according to the first embodiment; Fig. 7a is a perspective view of a second embodiment according to the present invention; Fig. 7b is a sectional view of the second embodiment, with one face of the housing removed, showing the actuator in an initial position; Fig. 8 is a sectional view of the second embodiment, with one face of the housing removed, showing the actuator in a polarization position; Fig. 9 is a sectional view of the second embodiment, with one face of the housing removed, showing the actuator in a used and locked position; Fig. 10 is a sectional view of a third embodiment, with one face of the housing removed, showing the actuator in an initial position; Fig. 11 is a sectional view of the third embodiment, with one face of the housing removed, showing the actuator in a polarization position; Fig.12 is a sectional view of the third embodiment, with one face of the housing removed, showing the actuator in a used and locked position; and Fig. 13 is a side view of the actuator of the third embodiment showing its keyway. DESCRIPTION OF THE PREFERRED MODALITIES Referring in detail to the drawings, Fig. 1 shows one embodiment of the present invention in use. The device 1 includes a substantially disc-shaped housing 2 which is designed to be relatively small, lightweight and easy to operate, such that the operator can operate the device using only one hand. The housing 2 is preferably formed of molded plastic, but may also be made of light metals, composites or other well-known materials. Therefore, an operator can take a blood sample from himself without the necessary help from another person. In addition, in clinical application, an operator can take a blood sample, for example, opening a patient's skin with a lancet, using only one hand, while performing another function with the other at the same time. For example, the operator could stabilize the patient's arm with the hand that is not used to operate the lancet.

An actuator 3 protrudes from the housing 2 (see Figs 2 and 3), including a button 3e that the operator pushes in order to handle the lancet, that is, control the lancet to perform the function of opening the skin of the lancet with the lancet. patient. In the embodiment shown in Figs. 1-4, the lancet is ergonomically designed to have a substantially disc-shaped housing, with two substantially circular faces 2a and 2b tapering to be joined together circumferentially with a peripheral surface 2c to form a hollow compartment therein. The faces 2a, 2b and the peripheral surface 2c form a substantially concave contour 2e in the area of the device through which the sharp tip is designed to protrude in order to perform the function of opening with the lancet. The concave contour 2e includes an opening 2f through which the sharp tip passes. The substantially concave contour 2e facilitates the alignment of the lancet device with the skin of the patient, to open the lobe of an ear, arm, toe, finger, etc., and is particularly well suited for alignment with a finger from the hand of a patient. The actuator 3 extends substantially perpendicularly from substantially the center of the face 2a as shown in Figs. 2 and 3. The body and button are designed so that the lancet can be easily and held between the thumb and one or more fingers of a single hand. The button is easily depressed by a thumb or one or more fingers to cause the extension of a cutting or puncturing instrument from the body 2. Fig. 5 shows a sectional view of the device shown in Fig. 2, taken at medium path between the faces 2a and 2b, that is, with the face 2a and the button 3a not shown. Although the face 2a is not shown, both faces, 2a and 2b, are circumferentially reinforced when they meet to form the peripheral surface 2c. A spring mechanism 5 is provided within the compartment formed by the housing 2. The spring mechanism 5 is pivotally mounted on the interior surface of the face 2b and swivels about a pivot post 6. The pivot post 6 may be an axis which is mounted on the face 2b or may be integrally formed, preferably as a part with the face 2b. Also, the pivot point 6 can be associated with the face 2a. In a preferred embodiment, the spring mechanism 5 is formed of elastic steel and can be flat or round in cross section. However, it is envisioned that the spring mechanism could be formed of plastic, composite or other materials. A first end 5a of the spring mechanism is sharpened to the shape of a tip or blade for performing the puncture or cutting operation of the skin. Preferably, the sharp tip or blade 5a is formed integrally with the spring mechanism. Alternatively, however, a needle tip or lancet blade could be attached to the first end of the spring mechanism. The spring mechanism is bent at a different angle 5b to form an actuation surface against which the actuator 3 biases the spring mechanism 5. The spring mechanism preferably strikes around the pivot 6 which fixes the spring around a tip to rotate when it is activated. Alternatively, the spring mechanism could be fixed at a pivot point without actually bending around an axis. A second end 5d of the spring mechanism terminates in a protrusion 2d which is formed in the housing as one or both sides, 2a and 2b. The protrusion 2d acts as a stop to stop the movement in an upward direction of the second end 5d of the spring and prevents the spring of its tendency from moving upwards as a reaction to the downward polarization of the first end 5a by the actuator 3 through of the driving surface 5c. In consequence of itby stopping the second end as indicated, potential energy is stored within the spring mechanism 5 in the downward drive of the sharpened end. A cross section of the axis 3a of the actuator 3 substantially appears at a central location on the face 2b in FIG. 5. A polarization part 3b is shown extending from the axis 3a. Fig. 6 shows a side view of the entire actuator 3. The button 3e is fixed substantially perpendicularly at one end of the shaft 3a. In this embodiment, the polarization part 3b is a flap with a ramp which extends radially from the axis 3a. The fin 3b begins as a very narrow part near the lower end of the shaft 3a and constantly widens in an upward direction from the upper end of the shaft 3b to form a ramp edge 3b1. A part of the shaft 3a1 extends down the ramp fin 3b to form an initial position of substantially unpolarized for the spring 5 when the actuator 3 is in the initial position, i.e., when the actuator 3 is in the position shown in FIG. Fig. 3 and no biasing force is applied against the spring 5. At the lower end of the shaft 3a, a flange 3d is fixed and extends substantially perpendicular therefrom. The upper surface 3f of the flange 3d terminates in the spring 5 in the initial position and prevents the actuator 3 from being withdrawn from the housing 2. A guide 7 is mounted inside the face 2b and includes a groove 7a through the which passes the fin with ramp 3b. The guide 7 ensures that the actuator 3 can not rotate so that the wing 3b always remains aligned with the operating surface 3c of the spring 5. The guide 7 also acts as an additional guarantee that the actuator can not be removed from the housing, since that the 3d flange would rest on the guide 7, thereby preventing the actuator from being restied, even if for some reason the spring 5 does not prevent the removal. In Fig. 3 a side view of the lancet device is shown, in the initial position. In the initial position, the spring 5 rests on the lower end 3a 'of the shaft 3a as indicated above. In this position, the button 3e and the upper end of the shaft 3a extend from the face 2a of the housing 2 as shown in Fig. 3. The extension of the button 3e to separate it from the face 2a is clearly visible even to an observer casual. Therefore, an operator can visually identify with ease a lancet device that has not been used. The lancet according to the present embodiment is operated as follows: The operator takes the single-use disposable lancet device 1 between the thumb and one or more fingers of a single hand. The operator then touches the skin of a patient that will open with the substantially concave contour 2e of the device as shown in Figs. 1 and 2. To perform the function of opening the lancet, the operator presses button 3e until the button contacts face 2a. The operator then removes the lancet device from contact with the patient's skin and discards it, after which a sample of the patient's blood can be taken and analyzed. With reference to Figs. 5 and 6, a description will now be given of the functions of the actuator 3 and the spring mechanism 5. When the operator presses the button 3e, the entire mechanism of the actuator 3 moves in a downward direction (the direction of the arrow shown in FIG. Fig. 6) with respect to the housing 2 and the spring mechanism 5. Due to this relative movement, the spring mechanism is forced to move along the actuation position of the ramp surface 3b 'of the part of polarization 3b, as shown in the imaginary positions in Fig. 6. This relative movement along the ramp pon causes the polarization part to exert a biasing force against the spring mechanism, which becomes a forced movement of the spring mechanism in a downward direction. At the maximum width of the bias ramp 3b, the sharp end 5a protrudes to its maximum position beyond the housing 2 as shown in the imaginary lines in Fig. 5, thereby puncturing the patient's skin. While the operator continues to push the actuator into the housing (i.e., in the "downward" direction described above), the spring slides from the ramp edge 3b1 and toward the notch 3c, to the locked position, where the spring mechanism abuts again with axis 3a. This results in a rapid return of the spring mechanism and the sharp end 5a to the housing 2 as shown in the solid lines in the Ficf. 5. The driving force of the return of the sharp tip 5a to the housing is the potential energy which has been stored in the spring mechanism 5, which is converted into kinetic energy when the spring mechanism 5 is no longer polarized by the edge with ramp 3b '. The notch 3c is formed by an upper surface of the polarization part coming into contact with the axis 3a, which in turn encounters a lower surface 3g of the button 3e, as shown in Fig. 6. When the spring mechanism remains in the locked position, in a substantially unpolarized condition, in the notch 3c, prevents the actuator 3 from being removed or sliding back from the housing to assume the initial position again. That is, the spring mechanism 5 ends at the upper surface of the polarization part, as shown in the imaginary lines of Fig. 6, when the spring mechanism and the actuator are in the locked position. Therefore, even if a person tries to physically contract the button 3e away from the housing 2, the person is prevented from doing so since the spring mechanism 5 prevents the upward movement of the actuator with respect to the housing. In Fig. 4 a side view of the lancet device is shown in the locked position. As described above, in the locked position, the spring 5 rests on the upper surface 3b "of the biasing part 3b and on the axis 3a. In this position, the button 3e touches the outer surface of the face 2a as is shown in Fig. 4. This contact of the button 3e with the surface of the face 2a is clearly visible even to a casual observer.Therefore, an operator can visibly identify with ease a lancet device that has been used and has This easily identifiable feature of the device prevents even a second contact of the device with the skin of a second patient, while also effectively preventing re-use of the device As discussed above, the button may be constructed and arranged in different ways and may have several forms other than those specifically illustrated in the drawings, for example, the button may have an elongated element in its pa The upper part touches or substantially touches the housing in the locked position, as illustrated. Alternatively, as illustrated in Figs. 3a and 3b, the button may comprise a cylindrical shaft 400 having an upper part that is substantially flush with the surface of the housing in the locked position. At least the upper part of the cylindrical shaft may be of a different color than the housing to allow easy viewing of the button in its unused outgoing position and in its used locked position. In addition, the button, in any of the modalities, can include an element in it that keeps the button in the initial position. For example, there may be a protrusion 402 on the axis of the button that prevents the button from being pressed into the housing to a point where it would cause the needle to protrude from the housing. Therefore, the button axis may include a fragile protrusion in it that would require its removal before using the device. As wellA hole may be included in the shaft through which a removable C-shaped staple or a removable tubular member may be inserted to prevent premature activation of the device.

Figs. 7 and 9 show another embodiment of a single use disposable lancet device according to the present invention. In this embodiment, the actuator 30 of the device projects through a position on the peripheral surface 20c of the housing 20. Each of Figs. 7b-9 shows a view of the second embodiment of the device having face 2a removed. Fig. 7a shows the second embodiment with face 20a in place. Both faces 20a and 20b are circumferentially reinforced when they meet to form the peripheral surface 20c. A spring mechanism 5 is provided within the compartment formed by the housing 20. The spring mechanism 5 is pivotally mounted on the interior surface of the face 20b and swivels about a pivot post 6. The pivot post 6 can be an axis which is mounted on face 20b or can be integrally formed with face 2b. In this preferred embodiment, the spring mechanism 5 is formed of elastic steel and can be flat or round in cross section. However, it is envisioned that the spring mechanism could be formed of plastic, composite or other materials. A first end 5a of the spring mechanism is sharpened to the shape of a tip or blade for performing the puncture or cutting operation of the skin. Preferably, the sharp tip or blade is formed integrally with the spring mechanism. Alternatively, however, a needle tip or lancet blade could be attached to the first end of the spring mechanism. The spring mechanism is bent at a different angle 5b to form an actuating surface 5c against which the actuator 30 biases the spring mechanism 5. The spring mechanism preferably strikes around the pivot 6 which fixes the spring about a tip to swivel when it is powered. Alternatively, the spring mechanism could be fixed at a pivot point without actually bending around an axis. A second end 5d of the spring mechanism terminates in a protrusion 20d which is formed in the housing. The protrusion 20d acts as a stop to stop movement in an upward direction of the second end 5d of the spring and prevents the spring of its tendency from moving upwards as a reaction to the downward polarization of the first end 5a by the actuator 30 through of the driving surface 5c. Accordingly, by stopping the second end as indicated, potential energy is stored within the spring mechanism 5 in the downward drive of the sharpened end. As shown in Figs. 7-9, a portion of the peripheral surface 20c of the housing 20 is substantially flattened in the areas through which the actuator 30 protrudes. The actuator 30 includes a drive button 30e which is substantially perpendicularly fixed at one end of the shaft 30a. A biasing portion 30b of the shaft 30a includes a tapered end 30b 'for uniform engagement of the driving surface 5c when the actuator is slid internally with respect to the housing. The tapered portion 30b1 progressively jumps to the outer diameter of the shaft 30a which forms the maximum actuation position of the actuator and spring mechanism, whose position, the sharp end 5a extends to its maximum position beyond the housing 20. In FIG. 8 the sharpened end 5a is shown in its maximally extended driving position. While the operator continues to push the actuator button 30a towards the housing surface, the biasing portion 30b of the actuator derives the actuating surface 5c from the spring mechanism 5, at which time the actuating surface 5c slips from the biasing part. 30b and towards the notch 30c, to the locked position, as shown in Fig. 9. This results in a rapid return of the spring mechanism and the sharp end 5a to the housing 20 as shown in Fig. 9. The driving force of the return of the sharp tip 5a to the housing is the potential energy which has been stored in the spring mechanism 5., which is converted into kinetic energy when the spring mechanism 5 is no longer polarized by the polarization part 30b. When the spring mechanism 5 remains in the locked position, in a substantially unpolarized condition, in the notch 30c, the actuator 30 is effectively prevented from being withdrawn or sliding back from the housing to assume the initial position again. That is, the spring mechanism 5 ends at the surface of the groove 30c when an attempt is made to remove the actuator from the housing. Therefore, even if a person tries to physically contract the button 30e away from the housing 20, the person is prevented from doing so since the spring mechanism 5 prevents the outward movement of the actuator with respect to the housing. In this embodiment, the actuator has no contact with the spring mechanism in the initial position, so that the spring remains in a state of substantially unpolarized in the initial position. The shaft 30a is further provided with a fixed flange 30d and extending substantially perpendicular therefrom, between the notch 30c and the button 30e. The flange 30d rests on the inner surface of the housing 20 in the initial position and prevents the actuator 30 from being withdrawn from the housing 20, as shown in Fig. 7. The compartment formed by the faces 20a and 20b is manufactured to a sufficient tolerance to maintain the actuator 30 in alignment with the spring mechanism 5 in this embodiment.

Similar to the first embodiment, when this mode is in the initial position, as shown in Fig. 7, the button 30e and one end of the shaft 30a extend from the peripheral surface 20c. This extension of the button 30e from the peripheral surface 20c is clearly visible even to a casual observer. Therefore, an operator can visually identify with ease a lancet device that has not been used. The lancet according to the present embodiment is operated as follows: The operator takes the single-use disposable lancet device 10 between the thumb and one or more fingers of a single hand. The operator then touches the skin of a patient that will open with the substantially concave contour 20e of the device as shown in Figs. 7a and 7b. To perform the function of opening the lancet, the operator presses the button 30e until the button has contact with the peripheral surface 20c. The operator then removes the lancet device from contact with the patient's skin and discards it, after which a blood sample can be taken and analyzed from the patient. When the operator presses the button 30e, the entire mechanism of the actuator 30 moves internally with respect to the housing 20 and the spring mechanism 5. Due to this relative movement, the spring mechanism is forced to move along the position of driving the surface with ramp 30b 'of the polarization part 30b and then against the driving part of the shaft surface 30b. This relative movement along the ramp and shaft surface causes the polarization mechanism to exert a biasing force against the spring mechanism, which becomes a forced movement of the spring mechanism in a downward direction, driving with it the sharp end 5a outside the housing 20, through the opening 20f and through the skin of the patient as shown in Fig. 8. When the actuator passes the actuation position and the function of opening with lancet is finished , the spring is then returned to the locked position, as described above and as shown in Fig. 9. In this position, the button 30e touches the outer surface of the peripheral surface 20c. This contact of the button 30e with the peripheral surface 20c is clearly visible even to a casual observer. Therefore, an operator can visibly identify with ease a lancet device that has been used and has to be discarded. This easily identifiable feature of the device prevents even a second contact of the device with the skin of a second patient, while also positively preventing reuse of the device. Figs. 10-13 show, however, another embodiment of a single use disposable lancet device according to this invention. This mode works substantially in a manner similar to the embodiment shown in Figs. 7-9, with the only difference in the configuration of the locking device. As such, only the locking device will be specifically described. During actuation of the device, as the operator continues to press the drive button 300e towards the surface of the housing 20c, the biasing portion 300b of the actuator derives the driving surface 5c from the spring mechanism 5, at which time the driving surface 5c it slides from the biasing part 300b and towards the keyway 300c, to the locked position, as shown in Fig. 12. This results in a rapid return of the spring mechanism and the sharp end 5a to the housing 20 as shown also in Fig. 12. The driving force of the return of the sharpened tip 5a to the housing is the potential energy which has been stored in the spring mechanism 5, which is converted into kinetic energy when the spring mechanism 5 is no longer polarized by the polarization part 300b. When the spring mechanism 5 remains in the locked position, in a substantially unpolarized condition, in the key slot 300c, the actuator 300 is effectively prevented from being withdrawn or sliding back from the housing to assume the initial position again. That is, the spring mechanism 5 terminates at the surface of the key slot 300c when an attempt is made to remove the actuator from the housing. Therefore, even if a person tries to physically contract the button 300 e away from the housing 20, the person is prevented from doing so since the spring mechanism 5 prevents the outward movement of the actuator with respect to the housing. Similar to the first embodiment, when this mode is in the initial position, as shown in FIG. 10, the button 300e and one end of the shaft 300a extend from the peripheral surface 20c. This extension of the button 300e from the peripheral surface 20c is clearly visible even to a casual observer. Therefore, an operator can visibly identify with ease a lancet device that has not been used. When the actuator passes the driving position (driving position shown in Fig. 11) and the lancet opening function is completed, the spring is then returned to the locked position, as described above and as shown in Figs. Fig. 12. In this position, the button 300e touches the outer surface of the peripheral surface 20c. This contact of the button 300e with the peripheral surface 20c is clearly visible even to a casual observer. Therefore, an operator can visibly identify with ease a lancet device that has been used and has to be discarded. This easily identifiable feature of the device prevents even a second contact of the device with the skin of a second patient, while also positively preventing reuse of the device. Fig. 13 is shown as a side view of the actuator 300 (ie, in a plane perpendicular to the plane along which the actuator 300 is shown in Fig. 12), to more clearly show the configuration of the slot key 300c (keyway 300c being shown in imaginary lines in Figs 10-12). The keyway 300c is essentially a notch which is cut or otherwise formed on the shaft 300a and which extends completely therethrough, will form an orifice through the entire thickness of the shaft 300a. The keyway 300c is formed and dimensioned to readily accept the spring mechanism 5 within and act as a locking device on which the spring mechanism rests, in case an attempt is made to return the actuator to the initial position . Although the invention has been described with reference to particular means, materials and modalities, it should be understood that the invention is not limited to the disclosed details and extends to all equivalents within the scope of the claims.

Claims (21)

1. CLAIMS 1. A single use disposable lancet device comprising: a housing; a spring mechanism mounted on a pivot in the housing, the spring mechanism comprising a sharp end, wherein the spring mechanism is mounted within the housing in a substantially unpolarized state; and an actuator for biasing the spring mechanism, the actuator being movable, with respect to the housing, from an initial position to a polarization position to a locked position, in that order; the actuator including a locking device which engages the spring mechanism to prevent the actuator from moving from the locked position; the housing including an aperture of specified size to allow the sharpened end to protrude outwardly therefrom from the housing in the bias of the spring mechanism and the sharpened end to contract back into the housing in the locked position; and the spring mechanism and the sharpened end being mounted within the housing in a substantially unpolarized state when the actuator is in the initial position, the spring mechanism being biased by the actuator when the actuator is in the polarized position, causing that the sharp end protrudes from the housing and the spring mechanism returning to a substantially unpolarized state when the actuator is in the locked position. A disposable disposable lancet device as recited in claim 1, further comprising: a pivot post mounted within the housing; wherein the spring mechanism is pivotally mounted around the pivot post and is pivotally polarized with respect to the pivot post in the polarization by the actuator. 3. A single use disposable lancet device as recited in claim 1, further comprising: a stop mounted within the housing; wherein the spring mechanism comprises a second end opposite the sharpened end, the second end being stopped in a predetermined direction by the stop during the biasing of the spring mechanism. 4. A single use disposable lancet device as recited in claim 1, wherein the housing comprises two face components joined by a peripheral surface to form a compartment therein. 5. A single use disposable lancet device as recited in claim 4, wherein it is mounted substantially in the center of one of the face components. 6. A single use disposable lancet device as recited in claim 4, wherein the actuator is mounted through the peripheral surface 7. A single use disposable lancet device as recited in claim 4, wherein the housing is substantially disk-shaped with the two face components comprising two substantially circular faces and the peripheral surface joining the circular faces along the circumferential edges. 8. A single-use disposable lancet device as recited in claim 1, wherein the actuator comprises: a button operable by one or more fingers of a user; an axis extending from the button and extending to the housing; and a polarization portion for touching and polarizing the spring mechanism in the movement of the actuator from the initial position to the polarization position; wherein the button visibly extends from the housing in the initial position. A single use disposable lancet device as recited in claim 8, wherein the biasing portion comprises a flap with ramp extending from the axis for progressive biasing of the spring mechanism while the button is pushed closer to the housing . 10. A laser devicedisposable single use as cited in claim 9, wherein the locking device comprises a notch formed between one end of the fin with ramp, the axis and the button, where, by pushing the button completely to be resting on the housing, the spring mechanism slides from the flap with ramp and towards the notch, thereby returning to a condition of substantially unpolarized and preventing the actuator from returning to the initial position; wherein, when the actuator is in the initial position, the button extends from the housing so that a user can visually identify the initial position easily and know that the lancet device has already to be used; and wherein, when the actuator is in the locked position, the button is close to the housing so that a user can visually identify the locked position easily and know that the lancet device has been used and should be discarded. 11. A disposable disposable lancetei device as recited in claim 8, wherein the actuator further comprises; a flange extending from one end of the shaft opposite to one end of the shaft extending from the button; wherein the flange abuts the spring mechanism in the initial position and prevents the actuator from being withdrawn from the housing. 12. A single-use disposable lancet device as recited in claim 8, wherein the biasing portion comprises a cone at one end of the shaft opposite an end of the shaft extending from the button and a rectangular part of the shaft extending from the cone for progressive polarization of the spring mechanism while the button is pushed closer to the housing. A disposable disposable lancet device as recited in claim 12, wherein the locking device comprises a notch formed in the axis, between the rectangular part and the end of the shaft extending from the button, in where, by fully pushing the button so that it rests on the housing, the spring mechanism slides from the rectangular part and into the notch, thereby returning to a substantially unpolarized condition and preventing the actuator from returning to the initial position; wherein, when in the initial position, a user can visually identify the starting position with ease and know that the lancet device has already to be used; and wherein, when in the locked position, a user can visually identify the locked position easily and know that the lancet device has been used and should be discarded. A disposable disposable lancet device as recited in claim 13, wherein the actuator further comprises: a flange extending from the axis between the notch and the end of the shaft extending from the button; wherein the flange abuts the inner surface of the housing when the actuator is in the initial position and prevents the actuator from being removed from the housing. 15. A single use disposable lancet device as recited in claim 12, wherein the locking device comprises a keyway formed through the shaft, between the rectangular portion and the shaft end extending from the button, wherein, by fully pushing the button to rest on the housing, the spring mechanism slides from the rectangular portion and into the keyway, thereby recreating a substantially non-polarized condition and preventing the actuator from returning to the initial position; wherein, when in the initial position, a user can visually identify the starting position with ease and know that the lancet device has already to be used; and wherein, when in the locked position, a user can visually identify the locked position easily and know that the lancet device has been used and should be discarded. A disposable disposable lancet device as recited in claim 15, wherein the actuator further comprises: a flange extending from the shaft between the keyway and the end of the shaft extending from the button; wherein the flange abuts the inner surface of the housing when the actuator is in the initial position and prevents the actuator from being removed from the housing. 17. A single use disposable lancet device comprising: a housing; a spring mechanism mounted in the housing, the spring mechanism comprising a sharp end, wherein the spring mechanism is mounted within the housing in a substantially unpolarized state; an actuator for biasing the spring mechanism, wherein the actuator can be moved, with respect to the housing, to bias the spring mechanism in order to extend the sharpened end so that it protrudes from the housing; means to indicate that the lancet device has not been used and that the lancet device has been used, wherein the means for indicating is movable with the actuator to move indicating that the lancet device has not been used and that the lancet device has been used. lanceta has been used; and means for preventing the lancet device from being used again after being used only once, wherein the avoidance means engages the actuator in the protrusion of the sharpened end from the housing. 18. A single use disposable lancet device as recited in claim 17, wherein the actuator comprises: a button operable by one or more fingers of a user; an axis extending from the button and extending to the housing; and a polarization portion for touching and polarizing the spring mechanism in the movement of the button towards the housing; wherein the means for indicating that the lancet device has not been used and has been used comprises two positions of the button with respect to the housing wherein the button visibly extends from the housing to show that the lancet device has not been used and wherein the button visibly contacts the housing to show that the lancet device has been used; and wherein the means for preventing the lancet device from being used again after having been used only once comprises a locking mechanism that locks the button in the position where the button touches the housing, thereby preventing the button from contracting and preventing the actuator from polarizing the spring mechanism more than once. 19. A single-use disposable lancet device as recited in claim 17, wherein the actuator comprises: a button operable by one or more fingers of a user; an axis extending from the button and extending to the housing; and a polarization portion for touching and polarizing the spring mechanism in the movement of the button towards the housing; wherein the means for indicating that the lancet device has not been used and has been used comprises two positions of the button with respect to the housing wherein the button visibly extends from the housing to show that the lancet device has not been used and wherein the button is substantially level with the housing to show that the lancet device has been used; and wherein the means for preventing the lancet device from being used again after having been used only once comprises a locking mechanism that locks the button in the position where the button touches the housing, thereby preventing the button from contracting and preventing the actuator from polarizing the spring mechanism more than once. 20. A single-use disposable lancet device as recited in claim 18, wherein the button includes an element to prevent actuation of the button. 21. A single-use disposable lancet device as recited in claim 19, wherein the button includes an element to prevent actuation of the button.