Patent Publication Number: US-2005125019-A1

Title: Lancet device and method

Description:
TECHNICAL FIELD  
      The present invention generally relates to lancets, and more particularly, to a magnetically driven lancet.  
     BACKGROUND OF THE INVENTION  
      In treating several medical conditions or injuries, samples of blood must be taken and tested. For example, to treat diabetes with insulin, blood sugar levels must be checked, or monitored, regularly. As a result, blood must be drawn from the individual requiring the check and tested by any one of a number of known methods. One such method is placing a small amount of blood on a test strip and having the test strip read in a specially designed meter.  
      Many advances have reduced the amount or volume of blood needed for medical tests. However, for many, drawing blood can be frequent. In addition, for many medical conditions or injuries, individuals draw their own blood without the need of professional medical personnel. The result of this has been the development of personal lancing devices for individuals to draw their own blood. Such devices cover a spectrum from simple, e.g., a finger pricking device (needle, pin, lancet), to quite complicated (mechanical or electronic devices).  
      Central to any device is the amount of pain resulting from its use. Many traits or characteristics have been identified as increasing or decreasing the pain associated with such devices. For example, vibration. Problems needing to be addressed in devices include reducing or eliminating vibration. Side-to-side vibration (transverse oscillation) of a lancet&#39;s tip while moving to puncture skin causes an irregular puncture, causing unnecessary pain and discomfort to a user. Repeated bouncing into and out of the skin occurs upon insertion of the lancet into the puncture or lancing site. This back-and-forth motion into and out of the skin is a pogo-stick effect or a form of longitudinal oscillation. Finally, speed of the lancing device into and out of the lancing site affects pain greatly. A slower speed of puncture and withdrawal from a site causes more pain.  
      Over the years both companies and individuals have strived to improve upon lancets. Goals include facilitating use of the lancets, reducing the pain caused by the lancets, reusability of lancet, ease of use, reducing size, reducing noise associated their use, etc.  
     SUMMARY OF THE INVENTION  
      The present invention is an improvement upon existing lancets. It is relatively easy to use and load with lancets presently on the market. It is quiet in use. The lancet tip moves quickly (into the skin and from the skin) and without vibration or oscillation to generate a quick and straight piercing in the user, both aspects reducing pain associated with the lancing process. The piercing depth can also be easily controlled or adjusted. In short, the device of the present invention can be customized to a particular users desires and repeated over and over so that each piercing is substantially the same.  
      Other advantages and aspects of the present invention will become apparent upon reading the following description of the drawings and the detailed description of the invention. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      In the accompanying drawings forming part of the specification, and in which like numerals are employed to designate like parts throughout the same,  
       FIGS. 1 and 2  are front perspective views of the device of the present invention:  
       FIG. 3  is an exploded view of the lancing device of the present invention;  
       FIGS. 4-9  are side elevation schematic views of the device showing the steps to arming the device;  
       FIG. 10  is a perspective front view of the dial adjuster and follower;  
       FIG. 11  is a cross-sectional view of the device showing the dial adjuster and follower;  
       FIG. 12  is a further sectional view of the dial adjuster, follower and lancet;  
       FIG. 13  is a close-up of portion of  FIG. 12  circled;  
       FIGS. 14-18  show the different lancet positions available by using the dial adjuster;  
       FIGS. 19-24  are side sectional views of the device showing the different positions of components during operation of the lancet within the device after arming and during puncturing;  
       FIGS. 25 and 26  are density plots of the magnet within the device and the magnetic fields generated thereby; and,  
       FIG. 27  is a schematic representation of the magnet, the magnetic fields and the collar in representative positions. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      While this invention is susceptible of embodiments in many different forms, there is shown in the drawings and will herein be described in detail, preferred embodiments of the invention with the understanding the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiments illustrated.  
      The present invention uses the full, complete, 360 degrees, magnetic field of a magnet to project the tip of a lancet outwardly from the device from a safe, steady state position to a puncturing position and to retract the lancet back into the protected, steady state position. The complete use of the magnetic field reduces oscillation, or movement, of the tip in directions other than the traveling direction of the tip. This greatly increases the efficiency of the lancet and reduces pain potentially caused thereby.  
      The Components of the Lancing Device  10   
       FIG. 1  is an exploded view of the primary components of the device, generally designated by reference number  10 . Central to the lancing device  10  is a magnetic element  20  and a collar  30 . The magnetic element  20  is preferably a solid cylindrical magnet having an outer surface  21 , a front end  22  and a rear end  23 . The magnet  10  further has a magnet diameter D1. The magnetic field(s) generated by the magnet  10  is shown in  FIGS. 25 and 26  and schematically in  FIG. 27 .  
      Generally, the cylindrical magnet  20  has two poles; one pole is charged North (N) on one flat end  23  and the other pole is charged South (S) on the opposing flat end  22 . This results in magnet field curved lines of flux being generated between both of the poles and around the entire circumference of the cylindrical magnet.  
      As shown in  FIG. 27 , the relationship between the magnet  20  and collar  30  are shown in three positions—Steady State (SS), Armed Position (AP) and Piercing Position (PP). As discussed in detail below, the magnet  20  is stationary and during arming, the collar  30  is moved along path  1  from a steady state position to an armed position. When the device  10  is activated, the collar moves along path  2  from the armed position to the piercing position and further along path  3  from the piercing position back to the steady state position. A representative point “A” on the collar is shown in the three positions.  
      The collar  30  is preferably an annulet, tubular having an outer surface  31 , a front end  32 , a rear end  33  and an inner surface  34 . The collar  30  is composed, at least in part, or has associated therewith material capable of being affected by the magnetic force(s) emanating from the magnet  20 . Thus, the collar  30  can be drawn or pulled towards the magnet  20  when the magnetic forces are attractive between the magnet and the collar. In the device of the present invention, the forces used are always attractive. Thus, the magnet is always drawing metal to it. Specifically referring to  FIG. 27 , the attractive forces of the magnet are drawing the collar towards the magnet (path  2 ) and the momentum of the moving collar causes the collar to move past the magnet. Once at the piercing position, the collar will stop and the drawing/attractive forces of the magnet will pull the magnet back to the steady state or equilibrium position. Suitable materials for the collar  30  are iron, steel (plated or stainless) or any ferrous metal. Preferably, the collar is made of stainless steel or any form of plated, non-corrosive steel. The annular inner surface  34  has a collar diameter D2 slightly greater than the outer diameter D1 of the magnet  20 . As a result, the magnet  20  can pass longitudinally through the collar  30 . In addition, the outer surface  34  of the collar has an circumferential channel  35  therein spaced from the rear end  33  of the collar  30  for cooperating with holding means to hold the collar in the arming position.  
      The magnet  20  is fixedly secured, preferably by force fitting or an adhesive, to an inner shaft  40  and the collar is fixedly secured, also by an adhesive, around a separate outer shaft  50 . Both the inner shaft  40  and the outer shaft  50  are generally tubular having front ends  42 , 52  and rear ends  43 , 53  with the inner shaft having an outer diameter D3 and the outer shaft having an inner diameter D4. The outer diameter D3 of the inner shaft  40  is less than the inner diameter D4 of the outer shaft  50 . This sizing allows the inner shaft  40  to move longitudinally relative to the outer shaft  50 . In short, the inner shaft  40  can ride and travel within the outer shaft  50 .  
      The inner shaft  40  also has an elongated longitudinal slot  44  therein, opposed holes  45  and a generally radial flange  46  projecting therefrom which aligns and retains the shaft  40  to the first housing component  110 . The outer shaft  50  similarly has an elongated longitudinal slot  54  therein. The outer shaft  50  also includes a receptacle section or portion  55  at the front end  52  thereof.  
      The lancet  60  generally has a centrally located body  61  with a front end  62  and a rear end  63 , a tip  64  projecting longitudinally and outwardly from the front end and a key  65  at the rear end. The outermost end of the tip  64 , spaced from the body  61 , is the point  66  of the tip for puncturing. The receptacle  55  in the outer shaft  50  is contoured and configured to receive and securely seat and hold the keyed end  65  of the lancet  60 . The lancet  60  is molded plastic, save the metal tip  64 , and can thus be customized. In addition, in the preferred embodiment, the receptacle  55  at the front end  52  of the outer shaft  50  is constructed so as to accept, seat, secure and hold commercially available lancets manufactured by others in the industry, such as ComforTouch™ by Lowen Mumford, Soft Touch™ by Roche Diagnostics and Ultra-Fine™ II by Becton, Dickinson &amp; Company (BD). Such customized construction of the lancet and receptacle portion of the shaft is easily understood by those in the art of molding and molding techniques. It is recognized that instead of customizing the front end  52  of the outer shaft  50  to be a receptacle  55 , one can optionally employ a separate insert (not shown) to attach to or in the front end of the outer shaft to act as the receptacle, and keyed for mating with the keyed end  65  of the lancet  60 . Thus, one can easily and regularly remove one disposable lancet  60  after use and replace it with a new lancet for future use.  
      Mentioned above, the outer shaft  50  moves (slides) relative to the inner shaft  40 . Discussed in more detail below, the lancet  60  secured to the outer shaft  50  moves relative to the inner shaft  40 . Specifically, the lancet  60  is moveable between a withdrawn position (wherein it is protected within the housing (discussed below)) and a piercing position (discussed below) wherein the tip  64  is fully extended, for the particular setting, to pierce the individual user with the point  66 . This movement by the lancet is driven the pulling caused by the magnetic forces of the magnet  20  and their interrelation with the collar  30 . See discussion relating to  FIG. 27 .  
      An arming member  70  is provided to arm, or move, the lancet  60 , collar  40 , outer sleeve  50  and inner sleeve  40  into position for use (piercing). This arming member  70  includes a front end  72  and rear end  73 , along with a gripping portion  74  at the rear end  73 . A centrally located aperture  71   a  is provided in the rear end  73  and gripping portion  74 . The arming member  70  is preferably made of molded plastic and may be double molded or coated with a high friction material so as to prevent the user&#39;s fingers from slipping from the member when the user pulls it rearwardly to arm the device. To facilitate gripping and this pulling action by the user (“arming”), a plurality of radially spaced annular recesses  75  and marginal walls  76  are constructed in the gripping portion  74 .  
      The mentioned aperture  71   a  opens up into tubular portion  71  projecting forwardly from the gripping portion  74 . This tubular portion  71  has an outer diameter D5, slightly less than the inner diameter D3′ of the inner shaft  40  to let the tubular portion slide within and relative to the inner shaft. A plurality of tangs  77 , formed between slots  78  are formed at the distal or front end  72  of the member  70 . A guide, or projection  79 , also extends radially outward from the end  72 . The tangs  72  provide a spring action ensuring the tubular section can be inserted into the inner shaft and slid longitudinally therein. They  79  also ensure the guide  79  is biased radially outwardly. This guide  79  is configured so as to project through and move relative to (when the arming member  70  is moved) both the longitudinal slot  44  formed in the inner shaft  40  and the longitudinal slot  54  formed in the outer shaft  50 .  
      In assembling the device  10 , the front end  72  of the arming member  70  is compressed and inserted into the rear end  43  of the inner shaft  40  until the guide  79  protrudes through the slot  44 . An extension spring  80  is then put into the inner shaft  40 , the front end of the spring being held in the shaft by a spring-retainer  81  inserted into one end of the inner shaft  40 . The spring-retainer  81  is fixedly secured by the extension spring applying a pulling force upon it, forcing a seat of the spring-retainer upon a mating ledge within the inner shaft  40 . Alternately the spring-retainer can be additionally further retained (by sonic welding, adhesives or other conventional methods) to the shaft  40 . The rear end of the spring  80  is held in the inner shaft  40  and arming member  70  by a passageway  85  provided in the body portion  84  of an end cap  83 . The end cap  83  seats within the centrally located aperture  71   a  in the rear end  73  of the gripping portion  74  of the arming member  70 . It is also understood that the end cap  83  can be molded integral to the tubular member  71  such that they are one component.  
      This assembly ensures the arming member stays connected to the inner shaft  40 .  
      Protecting the tubular portion  71  of the arming member  70 , the inner shaft  40  and magnet  20 , the outer shaft  50  and collar  30  and the dial adjuster  160  and follower  180  (discussed below) is an outer, concentric housing comprised of a first housing component  110  and a second housing component  130 . These components  110 , 130  mate with one another to generally protect the just noted internal workings of the device  10 . Each housing component  110 , 130  has an outer surface  111 , 131 , a front end  112 , 132  and a rear end  113 , 133  and abutting edges  114 , 134  for mating with the other housing component. In particular, the first housing component  110  has a ridge  115  running along the inner surface thereof along the abutting edge while the second housing component  130  has a plurality of barbs  135  projecting downwardly therefrom. The barbs  135  of the second housing  130  grip and hold the ridge  115  of the first housing member when the two  110 , 130  are put together or, more appropriately, snap fitted together. Adhesive, sonic welding, or compression tapered fitting can also be used to retain both housing components  110 , 130  together along their respective abutting edges  114 , 135 . As with the arming member  70 , the first housing  110  also includes one or more annular recesses  120  and walls  121  to facilitate gripping of the device  10 . The first housing member  110  further has an extension  117  extending rearwardly from rear end  113 . This extension fits between the tubular portion  71  and the gripping portion  74  of the arming member  70  when the device  10  is assembled and the arming member  70  is not extended. This housing component further includes a window  118  in the outer surface  111  to permit a user to rotate a dial  170  projecting therefrom and to view the setting or other indicia  171  (discussed below relating to adjusting the piercing position and the point  66  of the tip  64  of the lancet  60 ). Internal ribs  116  are also molded within the first housing component  110  to space the component from the internal mechanics or to hold the respective parts in their respective positions relative to one another.  
      The second housing member  130  has a central annular opening  136  therein, along with a two downwardly extending clips  137  to accommodate and hold a button switch  150 . The opening or window  138  is for viewing the numbers ( 171 ) printed or molded on the dial adjuster  160 . Internal ribs (not shown in  FIG. 1 ) are also molded within the second housing component  130  to space the component from the internal mechanics or to hold the respective parts in their respective positions relative to one another. While the housing is shown as two pieces, it is appreciated that it can, if desired, be a single piece.  
      The button switch is  150  is coupled to the second housing member  130  and is seated within the annular opening  136 . The button  150  has an outer surface  151 , front end  152 , rear end  153  and a touch pad  154  constructed/molded adjacent the front end. Centrally located are two downwardly extending flanges  155 , each with an outwardly projecting protuberances  156 . The protuberances  156  are snap fitted into the clips  137  of the housing  130 . This coupling of the housing  130  and button  150  together lets the button rotate relative to the housing. In short, the button  150  can pivot about the clips  137 /protuberances  156  like a rocker-switch or teeter-totter.  
      Adjacent the rear end  153  of the button switch  150 , below the portion rearwardly of the flanges  155 /protuberances  156 , a transverse crest  158  is provided. This crest  158  is a ridge or rib for mating with the circumferential channel  35  of the collar  30 . The crest  158  sits within the channel  35  when the device  10  is armed. Specifically, the collar  30  is released (or free to move or translate longitudinally) when the touch pad  154  is touched and the crest is pivoted away from and out of the channel  35 . It should be understood that the button my also incorporate conventional and well known means (springs, etc.) to bias the crest  158  towards and into the collar  30  and the channel  35 .  
      The cap  100  is juxtaposed or adjacent to the front ends  112 , 132  of the housings  110 , 130 . In the preferred embodiment, the cap  100  is not connected directly to the housing  110 , 130 , rather the cap  100  is connected to a follower  180  disposed between the housing  110 , 130  and the cap. The cap also has a front end  102 , a rear end  103  and an outer surface  101 . It  100  is pyramidal or conical, tapered towards the front end  102 . Both the front end  102  and rear end  103  of the cap  100  have openings  104 , 105 . The cap  100  protects the lancet  60  from dust and debris and protects the user, as well as others, from inadvertently contacting the tip  64  and point  66  of the lancet. The cap  100  can easily be removed from the housing  110 , 130  to remove and replace the lancet  60  and then reconnected to the housing.  
      To facilitate the removing and replacing of the cap  100 , the cap has one or more internal, circumferential, annular grooves  107  spaced from the rear end  103  to snap fit or engage one or more circumferential crowns  191  constructed on the external surface of the follower  180 . (See  FIG. 13 ).  
      In use, the user puts his/her skin against the front opening  104  of the cap  100  and activates the device  10 . Once activated, the tip  64  of the lancet is propelled from within the cap  100  to outside the cap and the point  66  moves from a withdrawn position (within the cap/housing) to it “piercing position,” that position furthest from the front end  102  of the cap to lance the user. After reaching the just noted piercing point, the tip  64  and point  66  withdraw to a position back within the cap  100 /and housing  110 , 130 .  
      The dial adjuster  160  works in conjunction with the follower  180  to adjust the cap  100  relative to the housing  110 , 130  and the lancet  60  and for selectively setting the positioning of the just mentioned piercing position. The follower  180  abuts, but is not secured to, the outer surface  51  of the outer shaft  50  generally adjacent the front end  52  and receptacle  55  of the shaft (when the device is in its steady state). The front end  182  of the follower  180  acts as a guide for the shaft  50  and the lancet  60  and reduces oscillation of the lancet when it is activated, projecting forward in the device and piercing. Specifically, the follower  180  contacts the outer shaft  50  a full 360 degrees; this minimizes lancet  60  oscillation during longitudinal motion of the lancet, translating into less pain during puncture.  
      The dial adjuster  160  is also not attached to the outer surface  51  of the outer shaft  50 . The dial adjuster  160  is screw fitted into the follower  180  and is maintained in position by the housing  110 , 130 . Consequently, the dial adjuster  160  is rotatable relative to the follower  180  to increase the distance or gap between the housing  110 , 130  and the cap  100 , or more particularly, between the point  66  of the lancet  60  and the front end  102  and front opening  104  of the cap. In short, rotation of the dial adjuster  160  translates to longitudinal motion of the follower  180  and cap  100  relative to the outer shaft  50 , lancet  60  and lancet point  66 .  
      It should be noted the dial adjuster  160  does not translate relative to the housing  110 , 130 , but the follower  180  along with the cap  100  do move (longitudinally) relative to the housing. The dial adjuster  160 , and hence the follower  180 , are held in place relative to the housing  110 , 130  by the dial  170  of the adjuster  160  projecting through one or more circumferential, annular windows  118  in the outer surface  111 , 131  of the housing components  110 , 130 .] 
      Adjusting the Piercing Position of the Lancet  
      The details of the interrelationship between the dial adjuster  160  and follower  180  are shown in  FIGS. 10-13 . Specifically, as with the other components, the follower  180 , which cooperates with the dial adjuster  160 , has a front end  182 , a rear end  183 , an outer surface  181  and an inner surface  184 . Similarly, the dial adjuster  160  has a front end  162 , a rear end  163 , an outer surface  161  and an inner surface  164 . Both the follower  180  and the dial adjuster  160  are tubular annulets and have threading. Specifically, the dial adjuster  160  has circumferential external helical threads  166 , or portions thereof, on the outer surface  161  adapted to cooperate with circumferential inner helical troughs  193  (internal threads) in the inner surface  184  of the follower  160 . The outer diameter of the dial adjuster is slightly less than the inner diameter of the follower. As a result, the external threats  166  mate with the internal threads  193  to permit rotation of the dial adjuster  160  relative to the follower  180 , or of the follower relative to the dial adjuster.  
      The outer surface  181  of the front end  182  of the follower  180  is contoured to match the rear opening  105  at the rear end  103  of the cap  100 . Spaced from the front end  182  of the follower are elongated crowns  191  for cooperating with one or more internal, elongated, circumferential grooves  107  formed in the inner surface  106  adjacent the rear end  103  of the cap  100 . A radial flange  190  on the follower  180  acts as a stop and abutment for the rear end  103  of the cap  100 . A tubular section  192  projects rearwardly of the flange for receiving the dial adjuster  160 . The tubular section  192  also includes an indicator  198  formed thereon behind the radial flange  190 .  
      A radial dial  170  is constructed, or molded, at the rear end  163  of the dial adjuster  180 . Like a flange, this dial extends outwardly from the outer surface  181  of the adjuster  180 . The outermost surface of the dial  170  is serrated to facilitate its gripping or fingertip rotation. The dial also includes a plurality of spaced apart radial peaks  172  and an indicator portion  171  having indicia thereon, such as number  1 ,  2 ,  3 ,  4  and  5 , to facilitate adjustment and of the dial adjuster. The peaks  172  coincide with the indicia so as to optionally hold the dial  170  in a desired position.  
      In particular, peaks  172  are provided to act as ratcheting or friction detent points which provide tactile feedback to the user turning the dial adjuster. The dial  170  of the adjuster  160  projects through one or more windows  118  in the outer surface  111 , 131  of the housing components  110 , 130 . The windows  118  also permits one to view the indicia on the indicator portion  171  of the adjuster  160 .  
       FIGS. 14-18  show the adjustment of the lancet device  10 . Noted previously, the dial adjuster  160  is rotated relative to the follower  180  to increase the distance or gap between the housing  110 , 130  and the cap  100 . As the dial  170  is rotated, the height of the follower  180 , and hence the cap  100 , changes. More particularly, this gap—shown as X 1 -X 5  in  FIGS. 14-18 , is the specific distance between the rear end  102  of the cap  100  and the front end  112 , 132  of the housing  110 , 130 . As the dial  170  is rotated, this gap (X 1 -X 5 ) increases or decreases. Rotation of the dial  171  and dial adjuster  160  translates to longitudinal movement of the follower  180  and attached cap  100 . As this gap increases (X 5  to X 1 ), the distance between front end  102  of the cap  100  and point  66  of the lancet  160 . Thus, the largest setting of the dial, indicated by the number  5  and gap distance X 5  in  FIG. 18 , provides the shortest distance between the cap end  102  and lancet point  66  when the lancet is in the withdrawn position. When activated, this small gap distance X 5  will translate to an increased, or furthest-most penetration, of the point  66  outside the cap end. In other terms, the piercing position, noted previously will become the greatest distance from the cap, resulting in the deepest or greatest penetration of the activated lancet  60 . Conversely, the smallest setting of the dial, indicated by the number  1  and gap distance X 1  in  FIG. 14 , provides the largest or longest distance between the cap end  102  and lancet point  66  when the lancet is in the withdrawn position. When activated, this large gap distance X 1  will translate to a decreased, or closest-most penetration, of the point outside the cap end. In other terms, the piercing position will become the smallest distance from the cap, resulting in the shallowest or smallest penetration of the activated lancet  60 . Intermediate gap distances X 2 , X 3  and X 4  are shown in  FIGS. 15-17 , respectively.  
      Arming the Lancing Device  10   
      The arming of the device  10  is shown in  FIGS. 4-9 . The process generally involves going from a “steady state” condition to a “fully armed” condition. In the steady state, or neutral condition or position, the lancet will not translate or project outwardly from the cap. In the fully armed condition/position, the device is ready for activation. When activated, the lancet translates longitudinally within the cap and projects outwardly from the cap to pierce or puncture the user. Immediately upon piercing, the lancet retracts and withdraws into the cap back to the steady state condition.  
      In  FIG. 4 , the “steady state” condition is depicted. In the steady state position, the following conditions occur or are observed: 
          a) The arming member  70  is not extended.     b) The collar  30  encircles the magnet  20  and the 360 degree magnetic forces emanating from the magnet hold the collar in place.     c) The inner shaft  40  and outer shaft  50  are oriented so that the collar is situated around the magnet.     d) The gripping portion  74  of the arming member  70  abuts the housing  110 , 130  and the tubular portion  71  is substantially within the inner shaft  40 . In addition, the extension  117  of the first housing member  110  is between the tubular portion  71  and the gripping portion  74  of the arming member  70 .     e) The guide  79  at the distal end of the tubular portion  71  of the arming member  70  projects through both the longitudinal slot  44  formed in the inner shaft  40  and the longitudinal slot  54  formed in the outer shaft  50 .     f) The button switch  150  is in the “disengaged position” wherein the crest  158  is disengaged from the channel  35  in the collar  30 . Consequently, the outer shaft and attached collar are free to physically slide longitudinally relative to the inner shaft and magnet.        

      In the next figure,  FIG. 5 , the “one-quarter extended” condition is depicted. In the one-quarter extended position, the following conditions occur or are observed: 
          a) The arming member  70  is pulled or drawn about one-quarter the distance from the housing  110 , 130 . As a result, the arming member is extended about one-quarter the total distance it is capable of being drawn from the housing.     b) The drawing of the arming member causes the guide  79  at the distal end of the tubular portion  71  of the arming member  70  projecting through both the longitudinal slot  44  formed in the inner shaft  40  and the longitudinal slot  54  formed in the outer shaft  50  to move rearwardly in both slots. The guide  79  contacts the rearward end of the outer shaft&#39;s slot  54 . Once the outer rearward end of the outer shaft&#39;s slot  54  has been contacted, any further drawing of the arming member  70  also draws the outer shaft  50  and collar  30 . In this figure, the outer shaft has moved rearwardly slightly.     c) The just noted movement of the outer shaft  50  longitudinally and rearwardly results in the same movement of the collar  30  from the steady state condition with the magnet  20 .     d) The inner shaft  40  and outer shaft  50  have been moved relative to one another. The collar  30  is no longer centered around the magnet  20 ; rather, the collar is slightly rearward of the magnet. The magnet forces radiating from the magnet are pulling the collar towards the magnet and to the front of the device, opposite the rearward motion caused by the pulling action on the arming member. Consequently, a user feels a slight resistance when drawing the arming member from the housing.     e) The gripping portion  74  of the arming member  70  is spaced distance A from the housing  110 , 130  and the tubular portion  71  is partially withdrawn from and extending rearwardly and outside the inner shaft  40 .     f) The button switch  150  is in the “disengaged position” wherein the crest  158  is disengaged from the channel  35  in the collar  30 . The outer shaft and attached collar are free to physically slide longitudinally relative to the inner shaft and magnet.        

      In the next figure,  FIG. 6 , the “one-half extended” condition is represented. In the one-half extended position, the following conditions occur or are observed: 
          a) The arming member  70  is pulled about half the distance from the housing  110 , 130 . As a result the arming member is extended about one-half the total distance it is capable of being pulled from the housing.     b) The drawing of the arming member causes the guide  79  at the distal end of the tubular portion  71  of the arming member  70  projecting through both the longitudinal slot  44  formed in the inner shaft  40  and the longitudinal slot  54  formed in the outer shaft  50  to move rearwardly in the inner slot. The guide  79  having contacted the rearward end of the outer shaft&#39;s slot  54 , now draws the outer shaft and collar  30  with the drawing of the arming member  70 . In this figure, the outer shaft has moved rearwardly.     c) The just noted movement of the outer shaft  50  longitudinally and rearwardly results in the same movement of the collar  30  from the steady state condition with the magnet  20 .     d) The inner shaft  40  and outer shaft  50  have been moved relative to one another. The collar  30  is further rearward of the magnet. The magnet forces flowing from the magnet continue to pull the collar towards the magnet and to the front of the device, opposite the rearward motion caused by the pulling action on the arming member. Consequently, a user continues to feel a slight resistance when drawing the arming member from the housing.     e) The gripping portion  74  of the arming member  70  is spaced distance B from the housing  110 , 130  and the tubular portion  71  is partially withdrawn from and extending rearwardly and outside the inner shaft  40 .     f) The button switch  150  is in the “disengaged position” wherein the crest  158  is disengaged from the channel  35  in the collar  30 . The outer shaft and attached collar are free to physically slide longitudinally relative to the inner shaft and magnet.        

      In  FIG. 7 , the “three-quarter extended” condition is represented. In the three-quarter extended position, the following conditions are present: 
          a) The arming member  70  is pulled about three-quarters the distance from the housing  110 , 130 .     b) The drawing of the arming member  70  causes the guide  79  to move rearwardly in the inner slot  44 . Because the guide  79  is contacting the rearward end of the outer shaft&#39;s slot  54 , drawing the arming member  70  also draws the outer shaft  50  and collar  30 . In this figure, the outer shaft has moved further rearwardly.     c) The just noted movement of the outer shaft  50  longitudinally and rearwardly results in the same movement of the collar  30  further from the steady state condition with the magnet  20 .     d) The inner shaft  40  and outer shaft  50  have been moved relative to one another. The collar  30  is further rearward of the magnet. The magnet forces flowing from the magnet continue to pull the collar towards the magnet and to the front of the device, opposite the rearward motion caused by the pulling action on the arming member. Consequently, a user continues to feel a slight resistance when drawing the arming member from the housing.     e) The gripping portion  74  of the arming member  70  is spaced distance C from the housing  110 , 130  and the tubular portion  71  is substantially withdrawn from and extending rearwardly and outside the inner shaft  40 .     f) The button switch  150  is in the “disengaged position” wherein the crest  158  is disengaged from the channel  35  in the collar  30 . The outer shaft and attached collar are free to physically slide longitudinally relative to the inner shaft and magnet.        

      In  FIG. 8  the “fully extended” condition is represented. In the fully extended position, the following are observed: 
          a) The arming member  70  is pulled completely from the housing  110 , 130  except for the furthest front portion of the tubular member  71  and guide  79 .     b) The drawing of the arming member  70  causes the guide  79  to move rearwardly in the inner slot  44 . The drawing of the guide  79  contacting the rearward end of the outer shaft&#39;s slot  54  draws the outer shaft  50  and collar  30 . In this figure, the outer shaft has moved further rearwardly so that the crest  158  in the button switch  150  is aligned with the channel  35  in the collar and the crest may be seated (by the user or by mechanical biasing means, such as a biasing spring) within the channel.     c) The outer shaft&#39;s  50  movement longitudinally and rearwardly results in corresponding movement of the collar  30  from the steady state condition with the magnet  20 .     d) The inner shaft  40  and outer shaft  50  have been moved relative to one another. The collar  30  is now completely rearward of the magnet. The magnet forces from the magnet act to pull the collar towards the magnet and to the front of the device, opposite the rearward motion caused by the pulling action on the arming member.     e) The gripping portion  74  of the arming member  70  is spaced distance D from the housing  110 , 130  and the tubular portion  71  is substantially withdrawn from and extending rearwardly and outside the inner shaft  40 .     f) The button switch  150  can now be engaged (the “engaged position”) from the “disengaged position” because the crest  158  is aligned with the channel  35  in the collar  30 . Once the button switch is engaged, the outer shaft and attached collar are basically held physically in position and prevented from sliding longitudinally relative to the inner shaft and magnet.        

      In  FIG. 9  the “fully extended” condition is again represented. However, once the collar  30  is engaged and held in position by the button switch, the user can push the gripping member  70  back to the housing  110 , 130 . Except for the movement of the guide  79  and tubular member  71  of the gripping member  70 , the just noted fully extended conditions are still in place.  
      The magnet forces emanating from the magnet  20  are, in essence, trying to pull the collar  30  towards the magnet and to the front of the device, but the collar is held in position by the button  150 . The device  10  is now armed and ready for use.  
      Operation of the Lancing Device  10   
      The activation of the lancing device  10  is shown in  FIGS. 19-24 . Specifically,  FIG. 19  shows the same situation as existing in  FIG. 9 , the completely armed position or condition. This is the also the initial point of activation or release. At this juncture: 
          a) The collar  30 , now rearward of the magnet  20 , is engaged (the engaged position) and held in position by the button switch  150 . The crest  158  is aligned and seated with the channel  35  in the collar  30 . The outer shaft  50  and attached collar  30  are basically held and locked physically and prevented from sliding longitudinally relative to the inner shaft  40  and magnet. The gripping member  70  abuts, or is adjacent, the back of the housing  110 , 130 .     b) The magnetic forces from the magnet  20  radiate to attract the collar  20  towards the magnet and to the front  102  of the device  10 .     c) The lancet  60  and its respective tip  64  and point  66  are in a totally or complete withdrawn position, protected completely by the cap  100 .        

      The touch pad  154  on the button switch  150  is touched, activating the device  10 .  
       FIG. 20  shows the device  10  and lancet  60  just after activation at an intermediate point of action. As shown: 
          a) The magnetic forces from the magnet  20  radiate to pull the just released collar  30  towards the magnet and to the front  102  of the device  10 . The magnet drives the just released collar, along with the outer shaft  50  and lancet  60 , to the front of the device.     b) The crest  158  is no longer seated with the channel  35  in the collar  30 , allowing relative motion between the inner shaft  40  and outer shaft  50 .     c) The lancet  60  and its respective tip  64  and point  66  are still withdrawn and completely protected by the cap  100  but moving quickly towards the cap&#39;s opening  104 .        
       FIG. 21  shows the device  10  and lancet  60  after the intermediate point of action and at the initial point of puncture. Specifically: 
          a) While the magnetic forces from the magnet  20  radiate to pull the collar  30  (now forward of the magnet), the momentum of the moving collar and outer shaft  50  drive the lancet further to the front  102  of the device  10 .     b) The crest  158  continues to be no longer seated with the channel  35  in the collar  30  allowing relative motion between the inner shaft  40  and outer shaft  50 .     c) The point  66  of the lancet  60  pierces the imaginary plain of the end  102  of the cap  100  and the cap&#39;s opening  104  and the transition begins wherein the lancet goes from a withdrawn position to a piercing position.        
       FIG. 22  shows the device  10  and lancet  60  at the fully hyper-extended position or “the piercing position,” namely that position wherein the point  66  of the tip  64  of the lancet  60  is fully extended and the furthest in front of the device  10 , cap  100  and cap opening  104 . Puncturing of the user is occurring. In particular: 
          a) While the magnet forces from the magnet  20  radiate to pull or retract the collar  30  (now well forward of the magnet), the momentum of the moving collar and outer shaft  50  drive the lancet to the furthest position in front  102  of the device  10 . The advancement of the lancet  60  is can be stopped when the front end  32  of the collar  30  bumps into the dial  170  of the adjuster  160 . At such point, all forward motion of the lancet  60  stops immediately. However, ideally, the advancement of the lancet  60  stops due to the properly balanced magnetic force. Such forces are sufficient enough to control the momentum of the collar/lancet. It should be noted that one of the significant advantages of the present device is that it is silent in use because parts do not bump or contact one another during motion. b) The crest  158  continues to be no longer seated with the channel  35  in the collar  30  allowing relative motion between the inner shaft  40  and outer shaft  50 .     c) The point  66  of the lancet  60  is well beyond the imaginary plain of the cap&#39;s  100  opening  104  and end  102 . Transition next begins wherein the lancet goes from the piercing position to a withdrawn position within the cap.        
       FIG. 23  shows the device  10  and lancet  60  after achieving the piercing position and in a retracting position, wherein the lancet is transitioning back to the steady state condition. Puncturing of the user has occurring and the lancet is withdrawing into the cap. In particular: 
          a) The magnetic forces from the magnet  20  retract the collar  30  towards the magnet. The lancet  60  having been well forward of the magnet is now drawn towards the magnet. As a result, the point  66  of the tip  64  of the lancet  60 , along with the outer shaft  50 , move back within the cap  100  and behind cap opening  104  to a withdrawn position.     b) The crest  158  continues not to be seated with the channel  35  in the collar  30  allowing relative motion between the inner shaft  40  and outer shaft  50 .     c) The point  66  of the lancet  60  is well behind (as opposed to in front) the imaginary plain of the cap&#39;s  100  opening  104 . The lancet  60  and its respective tip  64  and point  66  are withdrawing, completely protected by the cap  100  and moving away from the cover&#39;s opening  104 .        
       FIG. 24  shows the device  10  and lancet  60  in the steady state condition. The lancet is withdrawn, coming to rest, and the system to equilibrium. As shown: 
          a) The magnetic forces from the magnet  20  have retracted the collar  30  so that it encircles or is concentric with the magnet. The magnetic forces of the magnet basically hold the collar in this position.     b) The crest  158  remains unseated in the channel  35  in the collar  30  allowing relative motion between the inner shaft  40  and outer shaft  50 .     c) The point  66 , lancet tip  64  and lancet  60  are well withdrawn, well behind the imaginary plain of the cap&#39;s  100  opening  104  and are completely protected by the cap  100 .        
      The device is now in equilibrium and at rest. It will remain in this steady state condition until armed.  
      Interestingly, in the steady state condition, the device  10  can be dropped or jolted without the lancet  60  or tip  64  extending out of the cap  100 . The magnet&#39;s  20  magnetic forces hold the collar  30 , outer shaft  50  and lancet  60  within their grip. There may be slight relative motion between these parts, e.g., between the inner and outer shafts  40 , 50 , due to external forces, but they should only be slight.  
      The Magnetic Fields Generated by the Magnet  20   
      Discussed previously,  FIGS. 25 and 26  show density plots of the magnet  20  within the device  10  and the magnetic fields generated thereby in a steady state position ( FIG. 26 ) and at an extreme position (armed position or piercing position)( FIG. 25 ).  FIG. 27  shows a schematic representation of the magnet  20 , the magnetic fields and the collar  30  in representative positions. The magnetic field lines MF, or lines of force, associated with the magnet  20  are shown, each line being equal potential. The cylindrical magnet  20 , with substantially flat ends  22 , 23 , has a North pole N at one end and a South pole S at the opposed end. This results in magnet field curved lines of flux being generated between both of the poles N,S and around the entire circumference of the magnet. These magnetic field lines and the density plot thereof are shown in  FIGS. 25 and 26 .  
      The next figure,  FIG. 27 , shows the collar in three positions relative to the magnet, namely: a) the collar  30 ′ is in the steady state position (SS), b) the collar  30 ″ is in the arming position (AP), and c) the collar  30 ′″ is in the piercing position (PP). Note, this follows the progression of the collar relative to the magnet—Step 1: The steady state position (SS) to the arming position (AP); Step 2: The arming position (AP) to the piercing position (PP); and Step 3: the piercing position (PP) back to the steady state (SS).  
      Other Aspects of the Device  10   
      It should be emphasized that the magnet not only drives the lancet&#39;s tip (via the communicating annulet collar) out of the housing or cap, but also back into the housing or cap. Thus, the puncturing process of the present invention involves two steps, both an extension and a withdrawal or retraction of the lancet. This reduces prolonged puncturing and enhances safety of the device and its use.  
      It should be noted that the above system is described as mechanical. It can, however, incorporate electrical components. Such electrical components should be well recognized by those skilled in the art. For example, arming the device requires physically and mechanically pulling the arming member from the housing. This can also be accomplished by employing gears and an battery driven electrical circuit. In the embodiment described above, activating the device requires physically pressing the button switch. This too can be accomplished by an electronic circuit that uses an electric switch and gears and/or signals to release the collar.  
      In addition, the embodiment illustrated shows the magnet driving a collar in communications with the lancet. The magnet and collar can be switched so the magnet is in direct communications with the lancet and the magnet moves relative to the collar. Moreover, the magnet and collar are shown to be cylindrical and tubular respectively. It is believed this reduces oscillation or unwanted radial/lateral of the longitudinally moving lancet. Other shapes for the collar and magnet may be employed, such as rectangular, triangular, etc.  
      Further, the magnetic poles may be reversed in the embodiment shown. Thus, instead of the magnet drawing, pulling and attracting the collar, it can repel and push the collar and visa versa.  
      While the specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention and the scope of protection is only limited by the scope of the accompanying claims.