LANCET DEVICE UTILIZING A MAGNET AND METHOD OF MAKING AND USING THE SAME

Lancet device includes a magnet member, a sleeve member capable of being affected by magnetic forces emanating from the magnet member, and a movable lancet holder. At least one of the following is also utilized; a lancet releaser movable at least between an initial position and a position that allows a lancet to be removed from the lancet holder and a lancet holder lock movable at least between a lock position that prevents axial movement of the lancet holder along an axial direction and an unlock position that allows the lancet holder to move along the axial direction.

DETAILED DESCRIPTION OF THE INVENTION

The lancet device LD includes a number of components which will be described in detailed below with reference to the drawings. The main components of the lancet device LD include a lancet L, a body1formed of body sections2and3, a front cover or cap assembly10, a slide button20, a lancet holder assembly30and40, a movable sleeve assembly50, a lancet release system60, a holder lock system70, a magnet90, a metal sleeve95, a spacer member SM, a first spring S1, a second spring S2, a third spring S3and fourth spring S4.

The basic operation of the lancet device LD will now be described with reference to the drawings. Prior to use in forming a puncture, the lancet device LD is made ready. This can typically include installing a lancet L (seeFIG. 162) onto the front end of the member40(seeFIG. 7). To accomplish this, one typically first removes the front cap assembly10. Doing so automatically results in the member82being caused to move forward under the action of the spring S3(seeFIGS. 197-201). This, in turn, causes the lock member81to pivot downward so that the end81centers into or engages with the slot40jas shown inFIGS. 197 and 203, and as will be described in detail later on. In this way, the holding member40becomes locked in place so that it cannot move axially backwards and forwards. The benefit of this is that the user can now install a lancet L or remove a used lancet (seeFIG. 163) and then install a new lancet L. If the latter, the user can rotate member61against the biasing force of torsion spring S2to cause release of the old or user lancet L as shown inFIGS. 164 and 165). Once a new lancet L is installed, the user can reinstall the cap assembly10. When this happens, the member82is caused to move backwards and compresses the spring S3. This, in turn, causes the lock member81to pivot upward so that the end81cexits out of or disengages from the slot40jand assume the position shown inFIGS. 7,199and201. This results in the holding member40being unlocked or freed so that it can now move axially backwards and forwards.

Next, the user can, if desired, set a desired depth of penetration between a minimum and maximum range X as shown inFIG. 41and also when comparingFIG. 7andFIG. 10or11. This occurs by the user grasping the lancet device LD with one hand while two or more fingers of the other hand grip the cap member11and rotate it to a desired setting. When in an intermediate position, rotation of member11is one direction will result a shallower puncture while rotation in another direction will result in a deeper puncture. This is because such movement results the skin engaging plane P being positioned to a different axial distance in relation to a maximum axial movement of the holding member40. Owing to the design and configuration of the magnet90and sleeve95, this maximum movement is repeatedly precisely attained within a relatively small tolerance range. That is, no hard stops are necessary to attain this maximum movement toward the fully extended position unlike many existing lancet devices LD. However, it is also possible to provide for such a hard stop as an additional level of safety and/or as a backup system in case the magnet/sleeve system fail or become compromised for some reason. Maximum movement of the holding member40can be limited by the engagement between the slots40d(seeFIG. 83) and the projections30e(see FIG.73)—which engagement (seeFIG. 82) also prevents rotation of the member40while allowing member40to move axially relative to both the body1and the member30which is axially retained in the body1. An alternative and/or additional stop can be provided by utilizing contact between a proximal surface of the lancet L and the wall of the member11containing the lancet opening and plane P. It is desirable, however, that no contact occur between the lancet L and the lancet opening wall as it would render depth adjustment unavailable and generate sounds or noise. The elimination of hard stops is thus similarly desirable. One of many advantageous of using this type of magnetic device is that it is virtually silent. As an alternative depth adjustment procedure, the user can rotate member11in relation to member12while the cap assembly10is removed from the lancet device LD and then install the assembly10on the device LD.

Next, the user can now ready the device LD to form a skin puncture. To do so, the user grasps the lancet device LD with one hand and places the surface P in contact with a skin surface. While still grasping the device LD, the user slide button20backwards from the initial position shown inFIG. 7to that shown inFIG. 8. This action results in axial movement of the members52and51in a distal direction owing to contact between surface20cand surface52ias will be described in detail later on. Furthermore, owing to engagement between projections52fand slots40a, the holding assembly40is also cause to move axially in a distal direction. This, in turn, results in the sleeve95moving from a position centered over the magnet90toward a distal direction away from the magnet90. However, this distal movement toward a retracted position is opposed by the magnet90which would quickly bring the sleeve95back to the starting position if the slide button20were released by the user. This distal movement is also opposed by the spring S4which becomes compressed by the member52. During this distal movement, however, the member52begins to axially separate from or move away from the member51. This begins to happen when the projections51ccontact the flanges2pand3pwhich prevent any further distal axial movement of the member51. As the member52is further moved axially in the distal direction by the slide button20, the sliding engagement between the arms52eand portions51fand specifically between surfaces52gand51fresults in the projection52fcoming out of engagement with the slots40a. This disengagement can occur generally at the same time as the slide button20reaching, or nearly reaching, a distal-most position in the depression2b/3bas shown inFIG. 9.

As this engagement constitutes the sole mechanism coupling together the holding assembly40and the member52, the holding assembly40is now free to move axially to a maximum position shown inFIG. 9orFIGS. 10 and 11. It is at this precise point that magnet90begins to draw the sleeve95back to an original position through magnetic force. Of course, because the sleeve95is axially fixed to the assembly or member40, the member40with the lancet L arranged at its proximal end is drawn forwardly. The magnetic force exerted by the magnet90is such that it causes the sleeve95(and member40) to accelerate in the proximal direction, physics being what it is, the sleeve95and member40will acquire momentum and not initially stop at a position over the magnet90. Instead, in a manner analogous to a pendulum, it will travel past the magnet90until the force exerted by the magnet90overpowers the kinetic energy causing its forward movement—resulting in a deceleration of the member40and sleeve95to the point where the speed reaches zero. This is the point of maximum travel or the extended position. Furthermore, since the mass and configuration of the sleeve95remains constant and because the friction forces resulting from static surfaces contacting the member40are similarly constant or essential unchanging, and assuming the magnetic90retains its magnetic properties so that the magnetic force remains constant even after many, many uses, the point of maximum travel or the extended position will also be contact or essentially so all other things being equal. After a very short period of time, the sleeve95will settle back into a position over the magnet90from which it was moved initially. This position is characterized by the magnetic flux emanating from the magnet90and entrapping the sleeve95so that the forces causing a distal portion of the sleeve95to move axially forward are exactly balanced by the forces causing a proximal portion of the sleeve95to move axially backward.

Thus, the lancet device LD is both cocked and triggered by distal movement of the slide button20between the positions shown inFIGS. 7 and 9. Indeed, it is automatically triggered during cocking of the device LD. Moreover, movement of the holding member40toward the extended or puncturing position while the spring S4remains compressed by the action of the button20retaining the movement of the member52which has its distal surface in contact with a proximal end of the spring S4. Moreover, because the magnet90is fixed within a front end of the member30and the member30is prevented from moving axially, the magnet90remains axially fixed or static throughout all movements of the button20, members51and52, and especially member40and sleeve95.

Once the skin is punctured by the needle N of the lancet L passing through the lancet opening LO, the user can release the button20which will automatically be brought or moved forward via the member52under the action of the spring S4. During this movement, the member51is ultimately cause to contact the wall2k/3kand is stopped. However, the member52(which never completely separated from member51) continues to move forward until the projections52fare allowed to deflect inwardly and again engage with the slots40aof the member40. At this point the device LD is back to an original position as shown inFIG. 7and is ready to be used for another skin puncture—although it is recommended that the lancet L be replaced with a new one before this occurs.

With reference toFIGS. 12-27it can be seen that the body1, in accordance with one non-limiting embodiment, utilizes main components2and3and has an open front end and a closed and rounded rear end. The shape of the body1is generally made ergonomic (seeFIGS. 1-6) so that a user can more comfortably use and handle the same. This also makes it less effortless to activate or move the slide button20and release button61. A first component is a left-side body section or first portion2of the body1. A second component is a right-side body section or second portion3of the body1. When body sections2and3are joined together, they form a generally cylindrical connecting section via partially curved portions2aand3a. These sections2aand3aform a generally cylindrical surface which can receive thereon the surface12dof the cap assembly10(seeFIGS. 16 and 24). Also formed is a recess or depression defined by portions2band3b. These are sized and configured to receive therein the slide button20. Additionally, there is also formed is a recess or depression defined by portions2cand3c. These are sized and configured to receive therein the release button61.

Body section2also includes a guide depression2dsized and configured to receive therein and linearly guide one of the arms82dof the member82(seeFIGS. 190-196). Body section3similarly also includes a guide depression3dsized and configured to receive therein and linearly guide another of the arms82dof the member82. Body section2includes two through slots2eand2fsized and configured to receive therein and linearly guide portions61cand61eof the member61(seeFIGS. 166-172). Side surface2gis sized and configured to linearly guide the slide button20and can be contacted or slidably engaged by surface20d(seeFIGS. 67-72). Similarly, side surface3gis sized and configured to linearly guide the slide button20and can be contacted or slidably engaged by surface20d. An elongated through opening or slot is formed by portions2hand3hwhich together are sized and configured to receive therein portion20bof the slide button20. A generally circular flange is formed by portions2jand3jwhich together are sized and configured to form a front wall. Another generally circular flange is formed by portions2iand3iwhich together are sized and configured to form a distal wall. A space formed between these walls is sized and configured to receive therein the spring S3and member82. Another generally circular flange is formed by portions2kand3kwhich together are sized and configured to form a front wall. A space formed between the walls2i/3iand2k/3kis sized and configured to receive therein the spring S2and portion61f. Notch31formed in section3is sized and configured to receive therein and retain end S2cof the spring S2.

Body section2also includes flanges2mand2nand well as a generally rectangular opening2owhich is sized and configured to receive therein and axially and rotatably retain one of the projections3aof member30. Similarly, body section3includes flanges3mand3nand well as a generally rectangular opening3owhich is sized and configured to receive therein and axially and rotatably retain another of the projections3aof member30. The flanges2nand3nalso serve as contact surface for the distal end of the spring S4.

With reference toFIGS. 28-66, it can be seen that the cap assembly10, in accordance with one non-limiting embodiment, utilizes main components11-14. A first component is a cap member or cap portion11of the assembly10. A second component is a distal member or connecting interface portion12of the assembly10. A third component is a ring member or ring portion13of the assembly10. A fourth component is a retaining member or retaining portion14of the assembly10.

The cap member11includes a skin engaging surface11aand a lancet opening11bthrough which a lancet needle can pass during puncturing of the skin or tissue. Surface11acan be generally planar as shown or alternatively can be inwardly or outwardly curved as is utilized n known lancet devices. This surface can also include dimples or projections which are also known in lancet devices in order to, among other things, provide skin stimulation. Opening11bcan be generally circular as shown or alternatively can have another shape. Additionally, this opening can be of any desire size although it can be desirable that this opening not be too large so as to allow the skin surface to extend too deep into the opening and thereby allow too deep a skin puncture.

Cap member11also includes an outer surface11cwhich can in this case be generally tapered. Surface11cis sized and configured to be gripped by a user so as to allow the user to rotate the same in relation to component12which will be described in detail below. This rotation can be in opposite directions to provide depth adjustment and is facilitated by the surface11chaving a high friction area which in this case can take the form of grooves and projections that are more easily gripped that a plain and/or a more slippery surface. Other friction increasing devices can also be utilized such as a knurl or other type of textured surface. Cap member11also includes, at a distal end, a generally circumferential engaging surface11d. This surface11dis sized and configured to rotatably and/or axially slidably engage with surface12cof component12. An internal key projection11eis arranged within the cap11and is sized and configured to engage with slot or recess14bof component14. When so engaged, rotation of the cap11will cause a corresponding rotation of component14. Cap member11further also includes two generally oppositely arranged engageing projections11f. These projections11fare sized and configured to lockingly engage with corresponding recesses13bof component13. This serves to retain the cap11on the assembly10.

Component12includes an outer surface12awhich can in this case be generally cylindrical. Surface12ais sized and configured to slidably or rotably engage with a comparable inside surface13cof component13. A helical slot12bis sized and configured to receive therein two generally oppositely arranged inwardly oriented projections13dof the member13. Due to this engagement, when the cap11and ring13are rotated, the projections13dmove in and are guided by the slot12bin such a way that the cap11can both rotate relative to member12and also be guided axially relative thereto. As a result of this engagement, when the cap11is rotated in one direction, the cap11moves axially toward the member12whereas when the cap11is rotated in an opposite direction, the cap11moves axially away from the member12. This adjustment movement regulates the position of the skin engaging surface11ain relation to a non-changing maximum position of the lancet needle N (seeFIGS. 118-122) such that when the cap11is rotated in one direction, the cap11moves axially toward the member12and thereby provides a deeper skin puncture than when the cap11is rotated in an opposite direction, with the cap11moving axially away from the member12.

Generally cylindrical surface12cis sized and configured to be rotatably and/or axially slidably engaged by surface11dof component11. Generally cylindrical surface12dis sized and configured to be mounted to a corresponding surface of the body1of lancet device LD as will be described below and, in particular, to surfaces2aand3aof body sections2and3. This mounting forms a connection between the cap assembly10and the body1. Arranged at a proximal end of the component12are a series of projections and recesses12ewhich provide distinct retaining locations for a deflectable projection14dof the component14. The recesses12ediffer from one another in circumferential and axial spacial location and, in cooperation with the slot12band projections13dof component13serve to provide different depth of penetration settings. By rotating the cap11in relation to the lancet device LD and/or the component12, the user causes the projection14dto move into and out of engagement with a different one of the recesses12e. Moreover, due to this arrangement, an audible clicking “click” sound is generated each time the depth setting is changed. Additionally, the component12includes tapered indentations12fand a through main opening12g.

Component13includes an outer surface13awhich can in this case be generally tapered. Surface13ais sized and configured to frictionally engage with a comparable inside surface of component11and includes recesses13bsized and configured to receive therein two generally oppositely arranged inwardly oriented projections11fof the member11. In embodiments this surface13ais non-removably or permanently fixed, via e.g., adhesive bonding or ultrasonic welding, to the comparable inside surface of the cap11. Component13also includes projections13das described above and an annular surface13esized and configured to rotatbly engage with comparable annular surface12hof the member12.

Component14includes an outer surface14awhich can in this case be generally tapered. Surface14ais sized and configured to non-movably engage with a comparable inside surface of component11and includes a recess14bsized and configured to receive therein the projection11eof the member11. As a result, any rotation movement imparted to the cap11is transferred to the component14so that it rotates with the cap11. A deflectable arm14cis sized and configured to exert an axial biasing force against component12. This biasing force ensures that the projection14dclicks into and out of engagement with the recesses12eof component12when the cap11is rotated. The annular surface14erotatably engages with annular surface12iof the member12.

Referring now toFIGS. 67-72it can be seen how the slide or movable/slidable arming and trigger button20, in accordance with one non-limiting embodiment, can be a one-piece or integrally formed member. The slide20includes a finger engaging surface20awhich is sized and configured to comfortably receive a thumb when the lancet device LD is properly grasped by a user. Two oppositely arranged surfaces20dslidably engage with surfaces2g/3gof the body1and this engagement serves to linearly guide the slide20. The slide20also includes a projecting portion20bsized and configured to extend within the body1. The projection20bhas a distal projecting surface20cwhich is configured to contact surface52iof the projection52h.

Referring toFIGS. 73-104, it can be seen that the lancet holder or holding assembly, in accordance with one non-limiting embodiment, utilizes main components30and40. A first component is a proximal member or front portion40of the assembly. A second component is a distal member or rear portion30of the assembly. A metal sleeve95is slid over and is axially retained on a generally central area of the assembly. The sleeve95is that part of the lancet device LD which is influenced by a magnet90, and owing to its fixed connection to the holder40, causes axial movement of the holder assembly40.

The distal member30has a first end31and a second end32and includes two oppositely arranged projections30awhich are sized and configured to be axially retained between two flange portions2n/3nand3n/3mof the body1(seeFIGS. 12-27and104). A generally cylindrical internal space30bis disposed within the member30. In embodiments, the space30bis sized and configured to receive therein a spacer member SM (seeFIG. 104). A generally cylindrical outer surface30cof the member30is sized and configured to at least partially extend into the distal end of a generally cylindrical open space40bof the member40. Once a proximal end30dof the member30is inserted into a distal end of the member40, two oppositely arranged deflectable projections30eare sized and configured to slide within a respective slot of two oppositely arranged slots40dof the member40. Even though the member30is axially fixed within the body1, the member40can still move axially back and forth. The proximal end30dof the member30includes a proximal generally cylindrical space30fwhich is sized and configured to frictionally and/or fixedly receive therein the magnet90. Assembly of the member30with the member40can be accomplished by first installing the magnet90within the space30funtil the magnet90abuts an internal wall30gof the member30and installing the metal sleeve95onto the member40until the metal sleeve95abuts the outer projections40eof the member40. After this occurs, one can insert the proximal end30dinto the member40by an amount sufficient to ensure that the projections30ebecome engaged with the slots40dof the member40.

The proximal member40has a first end41and a second end42and includes two oppositely arranged recesses40awhich are sized and configured to receive therein the projections52fof the member52(seeFIGS. 126-161). A generally cylindrical internal space40bis disposed within the member40. In embodiments, the space40bis sized and configured to receive therein a proximal portion30d. A generally cylindrical outer surface40cof the member40is sized and configured to slide within the assembly50. This surface also receives thereon the sleeve95which abuts projections40e. Once a proximal end30dof the member30is inserted into a distal end of the member40, two oppositely arranged deflectable projections30eare sized and configured to slide within a respective slot of two oppositely arranged slots40dof the member40. The first end41is sized and configured to receive a lancet assembly L as will be discussed in detail herein. In this regards, an area of the first end41includes two oppositely arranged recesses40fwhich are sized and configured to receive therein the projections62aof the member62(seeFIGS. 164 and 165) and serve to axially retain the member62within a proximal portion of the space40bdisposed between an internal wall48gand the first end41. The member62is inserted into this space after a spring S1is first inserted so that the spring S1becomes compressed between the member62and the wall40g. Also arranged on the member40are four proximal slots40hwhich are sized and configured to receive therein four projections L1of the lancet L. One of these recesses40hincludes a releasable retaining recess40iwhich is sized and configured to receive therein a rotatable and axially movable projection63aof the member63. Still further, the member40includes a lock recess40jwhich is sixed and configured to receive therein a projecting portion of a lock member81. When so engaged, the engagement between the lock81and the recess40jprevents axial movement of the assembly40within the body1.

With reference toFIGS. 118-122and162-165, the lancet assembly, in accordance with one non-limiting embodiment, utilizes main components L,62,63and spring S1. A first component is a lancet L. This component L is a removable lancet having a needle N and that can be removed from the holder assembly or member40and can be replaced with a new one after use. A second component is a proximal member63. This component is designed to remain within the assembly40and can rotate and move axially within the assembly40. A third component is a distal member62. This component is designed to remain within the assembly40and does not rotate, but can move slightly axially within the assembly40. A spring S1is configured to bias the member62toward the member63and functions to maintain the locking position of the lancet L, but also allows the member63to be rotated to the point where it can release from the assembly40.

The lancet L has four projecting portions L1which are sized and configured to be axially slide within the slots or recesses40hof the member40(seeFIGS. 92-97). Surfaces L2are sized and configured to abut the fee ends of the member40when fully installed therein. A distal projecting portion L3extends distally from a main body portion of the lancet L containing the projections L1. The distal portion L3includes four projections L4are sized and configured to engage in a releasable locking manner with four generally L-shaped locking recesses63bof the member63. As will be described in detail later on, the configuration of members62,63, L and S1is such that a user cannot remove the lancet L from the end41of the assembly40until the member63ais cause to rotate to the point that the locking recesses63brelease from the projections L4.

Referring toFIGS. 105-117, it can be seen that the member63has a main projection63athat can be cause to rotate relative to the end41of the member40by the lancet release member61. Four locking recesses63bare sized and configured to receive therein the four projections L4of the member L. Four tapered recesses63care sized and configured to rotatably and slidably axially engage with four comparably shaped projections62bof the member62. The surfaces of the recesses63cand projections62bare such that they under the expanding action or biasing force of the spring S1, the member63is maintained in the locking position. However, when the projection63ais caused to rotate to a position allowing for release of the lancet L, the tapered surfaces of the recesses63cslidably engage (via cam action) with the tapered surfaces of the projections62band cause compression of the spring S1and movement of the projections62ato a distal-most axial position of the slots47f. The member63also includes a central recess63bsized and configured to receive therein (to provide axial alignment) with a central projection62dof the member62. The projections62aare arranged on two spiral shaped deflecting arms62cwhich function as springs. Inward deflection of the arms62callows the member62to be inserted within the end41. When properly inserted, the arms62cdeflect back to an original or relaxed position characterized by the projections62aextending into the slots40f.

With reference toFIGS. 126-161it can be seen how the slider or movable sleeve assembly50, in accordance with one non-limiting embodiment, utilizes main components51and52. A first component is a front sleeve member51of the assembly50. A second component is a rear or distal sleeve member52of the assembly50.

The first component51is generally a sleeve shaped member having an annular front end51a. A main through opening51bextends from the end51aand is sized and configured to receive therein the holding assembly40and allows it to move within it. Four corner projections51care arranged to linearly guide the member51in relation to the body1. Each projection51chas a surface which slidably engages with a surface in the body1so that the member51can slide axially back and forth within the body1without also rotating to any significant extent. Two oppositely arranged recesses51dare arranged to linearly guide and receive two projections52dof the member52. Each projection52dslidably engages with surfaces of the recess51din a manner which allows both members51and52to slide axially back and forth within the body1without also rotating to any significant extent relative to each other. Two oppositely arranged movement limiting recesses51eare arranged to linearly guide and receive two arms52eof the member52. Each arm52ehas an inwardly projecting portion52fwhich extends into one of the recesses51eand slidably engages with surfaces of the recess51ein a manner which allows both members51and52to slide axially back and forth (but to a limited extent) within the body1without also rotating to any significant extent relative to each other. When the lancet device LD is in the original position (seeFIG. 7), the surface51acontacts or abuts against surfaces2kand3iof the body1.

The second component52is generally a sleeve shaped member having an annular rear end52a. A main through opening52bextends from the end52aand is sized and configured to receive therein the holding member40and allows it to move within it. Four corner projections52care arranged to linearly guide the member52in relation to the body1. Each projection52chas a surface which slidably engages with a surface in the body1so that the member52can slide axially back and forth within the body1without also rotating to any significant extent. Two oppositely arranged projections52dare linearly guided and are received within two recesses51dof the member51. Two projecting arms52eslidably engage with surfaces of the recess51ein a manner which allows both members51and52to slide axially back and forth within the body1without also rotating to any significant extent relative to each other. The oppositely arranged movement limiting recesses51eare arranged to linearly guide and receive the two arms52eof the member52. Each arm52ehas an inwardly projecting portion52fwhich extends into one of the recesses51eand slidably engages with surfaces of the recess51ein a manner which allows both members51and52to slide axially back and forth (but to a limited extent) within the body1without also rotating to any significant extent relative to each other. When the lancet device LD is in each of three main positions, the surface52acontacts or abuts against a front end of the main spring S4. As will be described herein in detail, the act of placing the lancet device LD in the armed position, causes the member52to move axially away from the member51. When this happens, the projecting portions52fare cause to deflect outwardly and disengage from slots formed in the holder assembly30/40. This outward deflection results from each arm52eengaging with the surface51fand, more specifically, when each bent portion52gengages with a respective surface51f.

When both members51and52are installed within the lancet device LD, the main spring S4forces the member52towards member51so that the surface51acontacts surface formed by surfaces2kand3iof the body1. However, when a slide button20is moved distally to cause triggering of the lancet device LD (as shown inFIGS. 8 and 9), a projection20cof the slide button20contacts a surface52iof the projection52hand causes the member52to move distally.

A lancet release system60, in accordance with one non-limiting embodiment, is shown inFIGS. 164-172includes a one-piece or integrally formed release button or member61which is biased toward an original position by a torsion spring S2. The button61includes a finger engaging surface61awhich is sized and configured to comfortably receive a thumb when the lancet device LD is properly grasped by a user. The button61has two oppositely arranged surfaces61bwhich slidable engage with side surfaces of a groove formed in the body1(seeFIGS. 5 and 6as well asFIGS. 13 and 14). A connecting portion61cextends into a circumferential slot2eformed in the body1and connects an engaging portion61dto the main portion of button61. The engaging portion61dis sized and configured to contact and cause rotational movement of the projection63aand a corresponding rotation of member63during release and/or replacement of the lancet L. Another projecting portion61eextends into another slot2fof the body1and includes a biasing projection61f. The projection61fis sized and configured to extend into and engage with the bent portion S2bof the torsion spring S2. The other end S2cof the spring S2is designed to contact a surface2i/3jof the body1. As a result, when the user rotates the button61to a lancet release position, the coils S2aof the spring S2are cause to reduce in diameter slightly. When the button61is released, however, the spring S2assumes an original more relaxed position and moves the button61back to an original position (seeFIG. 6). The result is that the portion61dno longer engages with the projection63athereby allowing the member63to rotate back to a locked position under the action of compression spring S1.

The basic operation of the lancet removal or replacement system will now be described with reference toFIGS. 105-122and163-172. Prior to use in forming a puncture and to the lancet device LD being made ready, and assuming that no lancet L is installed on the lancet device LD, the user can install a lancet L onto the front end of the member40. To accomplish this, one typically first removes the front cap assembly10. Doing so automatically results in the member82being caused to move forward under the action of the spring S3. This, in turn, causes the lock member81to pivot downward so that the end81centers into or engages with the slot40j. This results in the holding member40being axially locked in place so that it cannot move axially backwards and forwards. The benefit of this is that the user can now install the lancet L without causing any axial movement of the holding member40. Moreover, owing to the engagement between projections30aand openings2o/3oas well as that between the slots40dand projections30e, the holding member40is prevented from rotating relative to the body1.

In one non-limiting manner, the user can rotate member61against the biasing force of torsion spring S2to a release position that is between about 45 degrees to about 90 degrees from an original position. Next, the user grips a lancet L and slides it (distal end first) axially into the front end of the holding member40. This is accomplished by aligning the projections L1with the slots40h. When the projections L4reach an innermost point, the user can release the button61which will cause the member63to rotate to the point where the projections defined by recesses63bto lockingly engage with the projections L4. Releasing the button61results in the force that was previously exerted on the projection63abeing reduced and allows the member to rotate to a locking position under the action of the spring S1and member62. When fully released, the slide61returns to an original position under the action of the spring S2and the lancet L is locked to the member40so that it moves axially therewith and cannot be removed unless the lock system is undone.

Once a new lancet L is installed (seeFIG. 162), the user can reinstall the cap assembly10. When this happens, the member82is caused to move backwards and compresses the spring S3. This, in turn, causes the lock member81to pivot upward so that the end81cexits out of or disengages from the slot40j. This results in the holding member40being unlocked or freed so that it can now move axially backwards and forwards. Next, the user can, if desired, set a desired depth of penetration.

In order to install a new lancet L after use of the device LD, the user must first remove the old lancet L. This is accomplished by the user first removing the cap assembly10as discussed above. Next, the user can rotate member61against the biasing force of torsion spring S2to a release position that is between about 45 degrees to about 90 degrees from an original position. This unlocks the old lancet L and allows it to be released or removed. At this point, the user grips the lancet L and slides it off the front end of the holding member40and preferably safely discards the same. The installation of a new lancet L can be accomplished in the manner noted above.

A lancet holding member lock system70, in accordance with one non-limiting embodiment, is described in reference toFIGS. 186-201and203and includes a one-piece or integrally formed pivoting lock member81which is biased toward a locking position by a compression spring S3. The member81includes a generally U-shaped mounting portion81a, and a connecting portion81b. An opening81dallows the member81to be pivotally mounted to an axel portion82aof ring-shaped member82. The rod portion81cis configured to engage with the slot40jof the member40. However, this locking engagement takes effect only when the front cover assembly10is removed from the lancet device LD. In this regard, the member82includes a body82bhaving an inner annular space82cwhich receives therein a portion of the spring S3. An opposite end of the spring S3contacts a flange2i/3kof the body1. Two oppositely arranged projecting arms82dprotrude fowardly from the body82band have free ends82ewhich can be contacted by annular surface12jof member12. When the front cap10is fully installed on the lancet device LD, the surface12jcontacts ends82eand axially moves the member82distally. This action compresses the spring S3and causes the member81to pivot out of engagement with the slot40jof the holding assembly40thereby. In this unlocked state, the holding assembly40can be moved axially back and forth. However, when the cap assembly10is removed, the reverse happens and the lock member81is cause to pivot down and engage with the slot40jof the assembly40and prevents axial movement thereof.

In accordance with one non-limiting embodiment of the invention there is provided a lancet device LD comprising a magnet member90, a sleeve member95capable of being affected by magnetic forces emanating from the magnet member90and a movable lancet holder40. At least one of the following is also utilized; a lancet releaser61,62and/or63movable at least between an initial position and a position that allows a lancet L to be removed from the lancet holder40and a lancet holder lock80movable at least between a lock position that prevents axial movement of the lancet holder40along an axial position an unlock position that allows the lancet holder40to move along the axial position.

In embodiments, the lancet device further includes a slide button20movable at least between at least one of: an initial position to a cocking or arming position, a first position defined by a front portion of the slide button being generally adjacent a proximal end of the lancet device and a second position defined by a rear portion of the slide button being generally adjacent a distal end of the lancet device; an initial position to a triggering position; and an initial position to an arming and triggering position.

In embodiments, the lancet device further comprises an axially movable arming/triggering device50that, is movable at least between a first position and a second position.

In embodiments, the lancet holder lock80comprises at least one of: an axially movable member82; a pivotally mounted projection81that engages with a recess or slot arranged on the lancet holder40, at least one projection adapted to moved when a front cap10of the lancet device is installed; and a compression spring S3.

In accordance with one non-limiting embodiment of the invention there is provided a method of using the lancet device LD of any of the types described above, wherein the method comprises moving the sleeve member95from a first position surrounding the magnet member90to a second more distal position and after the lancet holder40moves to toward an extended position, moving the sleeve member95back to the first position surrounding the magnet member.

The device(s) described herein preferably utilizes one or more features disclosed in prior art documents expressly incorporated by reference herein. The documents expressly incorporated therein are hereby fully or entirely expressly incorporated by reference in the instant application. Furthermore, one or more of the various parts of the device can preferably be made as one-piece structures by e.g., injection molding, when doing so reduces costs of manufacture. One-piece elements can also be made as multiple piece elements. Non-limiting materials for most of the parts include synthetic resins such as those approved for lancet devices or other medical devices. Furthermore, the invention also contemplates that any or all disclosed features of one embodiment may be used on other disclosed embodiments, to the extent such modifications function for their intended purpose.

Materials that can by way of example be utilized include ABS (possibly PC/ABS) for the housing(s). One or more other components can be made of Delrin (Acetal). The magnet can be made of Neodymium, Grade 52. See http://www.kjmagnetics.com/proddetail.asp?prod=D46-N52. The springs can be spring steel. Finally, the metal sleeve can be made of zinc plated low carbon steel.