Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150175—Adjustment of penetration depth
  • A61B5/150198—Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150022—Source of blood for capillary blood or interstitial fluid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
  • A61B5/150061—Means for enhancing collection
  • A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150503—Single-ended needles
  • A61B5/150519—Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
  • A61B5/150549—Protectors removed by rotational movement, e.g. torsion or screwing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/15058—Joining techniques used for protective means
  • A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
  • A61B5/150641—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
  • A61B5/150648—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position fully automatically triggered, i.e. the triggering of the protective sleeve does not require a deliberate action by the user such as terminating the contact with the patient's skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150694—Procedure for removing protection means at the time of piercing
  • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
  • A61B5/150824—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
  • A61B5/15101—Details
  • A61B5/15103—Piercing procedure
  • A61B5/15107—Piercing being assisted by a triggering mechanism
  • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
  • A61B5/15101—Details
  • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
  • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
  • A61B5/15101—Details
  • A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
  • A61B5/1513—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising linear sliding guides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
  • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
  • A61B5/15188—Constructional features of reusable driving devices
  • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
  • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
  • A61B5/15188—Constructional features of reusable driving devices
  • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
  • A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Definitions

• Lauuny devices arc typically handheld units that pemnt uscis to draw blood for testing and diagnostic pin poses These devices include ⁇ housing with a pie ⁇ ing aperture, a lancet tlut contains ona or nioic ueudics, and a fuing mechanism.
• he firing mechanism typically includes a vpmig us other biasing s ⁇ eanis vv iucli can be cocktd eiilicr b ⁇ insei iiou of the hirscoi or by pttUiug a cockin ⁇ hdiulk;, for example, v hice the Linciiig dt-vice is cocked, ⁇ is plficcd against the user 's skm.
• these depth adjustsnenf niechauisnis include adjustable stops that limit the fonvatd mov ement of the lance? din iiiL 1 iiring, hi other cases, depth adjustment mechanisms ⁇ uh,ust the tip of die lancing device to reduce or increase the distance that the needle sharp protrudes from the lancing device.
• depth adjustment Is illustrated in IkS. Pat, 5,984,040. A lancet holder is moved axially within a lancing device housing to move the needle closer Io or farther away Jiora the piercing aperture, thus adjusting penetration depth.
• lancets include safety features such as frangible tabs which cover the needk sharp prior Io insertion in the lancing device. Once the lancet is inserted, die use can break off and remove she frangible tab.
• Some lancets also include sleeves coaxially mounted to the main body of the lancet. The sleeve can be positioned so that it protectively encloses the needle sharp. During the lancing operation, the main body of the lancet slides through the sleeve to expose the lancet sharp.
• Lancing devices can draw blood from a user's Fingertip or other body part.
• a fingertip is a good testing site because it contains a large number of b ⁇ ood vessels and it is therefore easy to draw an adequate quantity of blood from the fingertip.
• fingertips are also sensitive and users who must frequently draw blood samples may experience discomfort from repeated sampling of the fingertips. Therefore, some users also perform lancing operations on parts of the body, and this is known as alternate site testing or alternate site incision, also known as "AST.”
• a piercing aperture acts as an expression ring by allowing the skin to pucker into the aperture's opening and by compressing a wider area of skin around the incision.
• a piercing aperture thai is suitably wide for AST lancing may be too wide for finger testing.
• some lancing devices provide removable endcaps with different si/.e piercing apertures.
• a user attaches one endcap (with a wider piercing aperture) when the lancing device is used for AST ' lancing; and a different endcap (with a more narrow piercing aperture) when the lancing device is used for fingertip lancing.
• the piercing aperture is adjustable in size, as illustrated in US Pat. Application 2004/023625] .
• the smaller size is used during the incision, whether on a finger tip or alternate site.
• the piercing aperture is expanded to provide a larger opening that can be used to express the desired quantity of blood from an alternate site.
• the size of the piercing aperture can be adjusted by moving a reference member into the pieiclng aperture, effectively obstructing the opening and piovidiug a flat surface against which the user's skin (finger tip or alternate site) is pressed for lancing. After the incision is made the reference member is retracted to provide an unobstructed, relatively wide expression opening.
• the reference member be attached to the lancet itself. During incision., the lancet and the reference member ate moved together toward the piercing aperture to effective!), narrow the piercing aperture. After incision, the reference member and the lancet are retracted to leave the piercing apeitiue unobstructed. Pi tor to the lancet's insertion into the lancing device, the reference member can be adjusted relative to the lancet for purposes of regulating die penetration depth ol the needle.
• the iuvcutiotu a lancet has an elongated body with a needle terminating in a shatp lip and a sleeve having a front end and a rear end.
• the sleeve is disposed about at least a portion of the elongated body and movable relative to the elongated body between a forward position in which the sharp tip is protectively surrounded by the sleeve and a rearward position in which the sharp tip projects I ⁇ OHI the front end of the sleeve.
• a first locking member extends from the elongated body at a location in between the forward and rearward positions.
• the first locking member has an extended configuration in which the locking member engages the sleeve to prevent the sleeve from moving rearward.
• the first locking member also has a retracted configuration i « which the locking member docs not engage the sleeve to prevent the sleeve from moving rearward.
• a lancet is provided having an elongated body with a needle terminating in a sharp tip and a sleeve having a front end and a rear end.
• the sleeve is disposed about at least a portion of the elongated body, the sleeve located at an initial posiuon relative to the elongated body so that the sharp lip is disposed within the sleeve.
• ⁇ first locking member extends from the elongated body at a location outside of the sleeve and has an extended configuration m which the first locking member engages the sleeve to prevent icarward movement of the sleeve and a retracted configuration in which the first locking member does not engage the sleeve to prevent the sleeve from moving rea ⁇ vaui
• a second locking member is also provided.
• the second locking member is axiaily spaced from tl ⁇ e first locking member and extends from the elongated body at a location within the sleeve.
• a method for usum u lanc ⁇ that has t m e longated body with a needle terminating in a sharp tip, a sleeve disposed about at least 3 portion of the elongated body and movable re lative to the elongated body, and ⁇ locking member ihaf has extended and retracted configurations.
• I he method includes positioning die slueve is in a forward position in which the sharp tip is protectively surrounded by at least a portion of the sleeve: placing the locking irienibei is i ⁇ the extended eonfignt.'Ui ⁇ n to prevent rearward movement of the sleeve; loading the lancci into a lancing device; moving the locking member into the retracted position before filing the laueing device to permit the sleeve to move rearward over the locking member; and containing the locking member in the retracted position while the sleeve moves over the locking member.
• FIG. i is a perspective view of a lancing device in accordance with one embodiment of the invention, including a removable lancet inserted therein: I UOl 7]
• Fig. 2 is a left side view of the lancing device of Fig, 1 ;
• FIG. 3 is top plan view of the lancing device of Fig, 1 ,;
• Fig. 4 is a bottom plan view of the lancing device of Fig. 1 ;
• Fig, 5 is a perspective view of a lancet for use with the lancing device of Fig. 1 , including a removable tab and a sleeve in an extended position to protectively surround the lancet ' s needle;
• Fig. 6 is a perspective view of the lancet of Fig. 5 showing the sleeve moved to a rearward position to expose the needle ' s sharp tip;
• Figs. 7a through 7d are a series of diagrams showing the general operation of the lancing device and lancet of Figs 1 -6;
• Fig, 8 is a top plan view of the lancet body of the lancet of Fig. 5;
• FIG. 9 is a left side view of the lancet body of Fig. 8.
• FIG. 10 is a perspective view of the sleeve in the lancet of Fig. 5;
• Fig. 1 1 is a left side view of the sleeve of Fig. 10;
• Fig. 12 is a top plan view of the sleeve of Mg. 10;
• FIG. 13 is a isolated perspective view showing detail of the lancet of Fig. 5, including the rear end of the sleeve and the wings on the lancei body that prevent rearward movement of the sleeve relative to the lancet body;
• Fig. 14 is a front view of the lancet sleeve of Fig. 10;
• Fig. 1 5 is rear view of the lancet sleeve of Fig. 10;
• Fig. 16 is a cross-sectional view of the lancet sleeve of Fig. 10 taken along (he lines 16-16 in Fig. 14;
• Fig. 1 7 is an exploded perspective view of the lancing device of Fig. 1 ;
• Fig, 18 is a cross-sectional view of the lancing device taken along the lines 18-18 of Fig. 3, including the lancet of Fig. 5 as inserted into the lancing device;
• Fig. 19 is a partial perspective view o ⁇ internal components of the lancing device of Fig. 1 showing drive springs and a portion of the lancet of Fig. 5 as inserted into the lancin 1 1 gSS device;
• Fig, 20 Is a perspective view of the left half of the housing of the lancing device of lug. I ;
• FIG. 21 is a perspective view of the right, hali ' of the housing of the lancing device of Fig. 1 ;
• Fig, 22 is a lefi-fro ⁇ t perspective view of the lancet can ior of Fig. 17;
• Fig. 23 is a right-front perspective view of the lancet carrier of Fig. 17;
• Fig. 24 is a perspective view of the cocking handle of Fig. 17;
• Fig. 25 is a front perspective view of the depth adjustment ring and depth actuator of Fig. 17;
• Fig. 26 is rear perspective view of the depth adjustment ring of Fig, 17;
• Fig. 27 is a perspective view of the trigger of Fig. 17;
• Fig. 28 is a top plan view of the trigger of Fig. 27;
• Fig, 29a is a. right side view of the trigger of Fig. 2.6 and its relationship with the lancet carrier of Fig. 22 (shown in phantom lines) showing the position of the trigger relative to the housing of the lancing device when the lancing device is cocked:
• Fig. 29b is a right side view of the trigger of Fig. 26 and its relationship with the lancet carrier of Fig, 22 (shown in phantom lines) showing the position of the trigger relative to the housing of the lancing device when the lancing device is uncocked;
• Figs. 30a through 30d are a series of cut-away right-hand perspective views of the lancing device of Fig. 1, illustrating its cocking and firing operation;
• Fig. 31 is an isolated perspective view of the: cap of the lancing device of Fig. 1, showing the position of the lancet sleeve when lancing device is in linger mode;
• Fig. 32 is an isolated perspective view of the cap of the lancing device of Fig. 1 , showing the position of the lancet sleeve when lancing device is in AST mode;
• Fig. 33 is a left side, view (with housing cut away to reveal interna) mechanisms) of the lancing device in AST mode with the cap placed on a user's skin in preparation for lancing operations;
• Fig. 34 is s a left side (with housing cut away to reveal internal mechanisms) of the lancing device in linger mode with the cap placed on a user's finger in preparation for lancing operations;
• FIG. 35 is front perspective view of the .AST mode actuator ring of Fig. 17;
• Fig, 36 is a lront view of ihe AST mode actuator ring Of ) 7 Ig, 35 and its relationship with the receiver of Fig. 1 7 (shown in phantom lines); [0053 j Fig. 37 is a rear perspective view of the AST mode actuator of Fig, 35;
• Fig. 38 is a front perspective view of the receiver of Fig. 17 and its relationship with the AST mode actuator ring;
• Fig. 39 is a front perspective sectional view of the receiver of Fig. 38, taken along the lines 39-39 in Fig. 33;
• Fig. 40 is a rear perspective view of the receiver of Fig. 38 with a lancet inserted therein;
• Fig. 4 ⁇ is a rear view of the receiver and lancet of Fig. 40;
• Fig. 42 is a front view of the receiver and lancet (shown in phantom lines) of Fig.
• Fig, 43 is a left aide view of the receiver of Fig. 38;
• Fig. 44 is a top plan view of the receiver of Fig. 38;
• Fig. 45 is an exploded perspective view of the ejection slide, ejection actuator and locking member of Fig. ) 7;
• Figs. 46a-46d are a series of cut-away right-hand perspective views of the lancing device of Fig. I , illustrating the operation of the ejection slide and ejection actuator;
• Fig. 47a is a partial perspective view of a lancing device in accordance with a further embodiment
• Fig, 47b is a side elevation of the cap of the lancing device shown in Fig. 47a;
• Fig. 48 is a top plan view of a lancing device in accordance with a further embodiment
• Fig. 49 is a partial sectional view of a lancing device in accordance with a further embodiment, taken along the lines 49-49 in Fig. 48;
• FIG. 50a is an isolated perspective view of the lancing device of Fig. 1 , showing the. position of the lancet sleeve protruding beyond the piercing aperture to adjust penetration depth of the needle sharp;
• Fig. 50b is a left side view (with the housing cut away to reveal internal mechanisms) of the lancing device as shown in Fig. 50a, with the lancet, sleeve protruding beyond the piercing aperture and placed on a user's skin in preparation for lancing operations; l " 0069]
• Fig. 51 is an exploded perspective view of a lancing device in accordance with a second embodiment of the invention.
• J 00701 Fig. 52a is a perspective view (with the housing in phantom lines to rcvcai internal mechanisms) of the lancing device of Fig. 51 , showing a stopper in an open position;
• j Fig. 52b is a perspective view (with the housing in phantom lines to reveal internal mechanisms) of the lam-ing device ⁇ i ' Hg. 52a, showing the stopper in a closed position;
• Mg. 53a is a top plan view (with the housing in phantom lines to reveal interna! mechanisms) of the lancing device as shown Fig. 52a, with the stopper in an open position;
• Fig. 53b is a top plan view (with the housing in phantom lines to reveal internal mechanisms) of the lancing device as shown in Pig. 52b. with the stopper in a closed position;
• Fig. 5-1 is a perspective view of the stopper of Figs, 52a and 52b;
• Fig. 55 is a top plan view of the stopper of Fig. 54;
• Fig. 56 is a bottom plan view of the stopptr of Fig. 54;
• tig. 57 is front elevation view of the stopper ⁇ i ' Fig. 54;
• Fig. 58 is left-side elevation view of the stopper of Fig. 54;
• Fig, 5 C > a rear elevation view of the stopper of Fig. 54:
• FIG. 59 A is partial perspective view of an alternative embodiment of ihe ianci ⁇ g device of Fig. 51, showing an ejection slide engaging a stopper in an open position; f 0081 ]
• Fig. 59B is a bottom plan view of an the engagement siide and slide and stopper of Fig. 59 ⁇ ;
• J Fig. 59C is a top plan view of an engagement slide and stopper in accordance with an alternative embodiment ol the invention, showing the stopper in an open position;
• Fig. 59D is a top plan view of the engagement slide and stopper of Fig. 5 ⁇ C. showing the stopper in a closed position;
• FIG. 60a is a perspective view (w ⁇ h the housing in phantom hues to reveal internal mechanisms) of the lancing device of Hg. 51 , showing a trigger and a locking member in a disengagement position;
• FIG. 60b is a perspective view (with the bousing in phantom lines to reveal internal mechanism-, ⁇ of the lancing device of Fig. 60a, showing the locking member in an engagement position;
• Fig. Cs Ia is a top plan view (with the housing hi phantom lines to reveal internal mechanisms) of the lancing device as shown Fig. 60a, with the locking member in a disengagement position ;
• Fig. 61 b is a top plan view (with the housing in phantom lines to reveal internal mechanisms ' ) of the lancing device as shown in Fig. 60b, with the locking memhcr in an engagement posi tion;
• Fig, (31c is a top plan view (with the housing in phantom lines to reveal internal mechanisms) of the lancing device as shown Fig. 60b with a lancet inserted therein;
• FIG. 62 is a front perspective view of the locking member of fugs. 60a and 60b;
• Fig. 63 is a rear perspective view of a locking member of Fig, 62;
• Fig. 64 is a front elevation of the locking member of Fig. 62;
• Fig. 65 is rear elevation of the locking member of Fig. 62;
• Fig. 66 is a right side view of the locking member of Fig, 62;
• Fig. 6? is a left side view of the locking member of Fig. 62;
• Fig. 68 is a top plan view of the locking member of Fig. 62;
• Fig. 69 is a bottom plan view of the locking member of Fig. 62;
• FIG. 70 is an isolated perspective view of ihe trigger and locking member of Fig.
• Fig. 71 is a sectional view of the trigger and locking member of Fig. 70 taken along the lines 73 -71;
• Fig. 72 is a perspective view of a carriage assembly of the lancing device of Fig.
• Fig. 73 is a partial exploded view of the carriage assembly of Fig. 72;
• FIG. 74 is a front perspective view of a carriage in the carriage assembly of Fig.
• Fig. 75 is a rear perspective view of the carriage in the carriage assembly of Fig.
• Fig. 76 is a side elevation of the right half portion of the housing shown in Fig.
• Fig. 77 is a front perspective view of a carriage cover of the carriage assembly of
• Fig. 7BA is an enlarged perspective view of a depth adjuster of the lancing device shown in Fig. 51, illustrating its interaction with the carriage assembly of Fig. 72;
• Fig. 78B is a rear perspective view of the depth adjuster of Fig. ?8A;
• FIG. 79 ⁇ is a partial perspective view of an alternative embodiment of the carriage assembly of Fig. 72, showing the engagement of a cocking assembly with the carriage assembly;
• Fig. 79B is a sectional view of the carriage assembly as shown in Fig. 7 ⁇ A; K)
• Fig. 80 is a front perspective view of the trigger assembly of the lancing device oi '
• Fig. 81 is an exploded, rearward perspective view of ike trigger assembly oi ' Pig.
• Fig. 82 is a lancet in accordance with an alternative embodiment of the invention, showing the laucet sleeve (in sectional) in its fully extended and locked position;
• Fig. 83 is side elevation of showing the lancet sleeve in its retracted position
• Fig. 84 is an enlarged side elevation of the lancet of Fig. 82;
• Fig, 85 is a perspective view of a lancet in accordance with another embodiment of the invention.
• Fig. 86 is a rear perspective view of the lancet of Fig. 85. with a portion of its sleeve cut away to reveal its interior structure;
• FIG. 87 is a front perspective view of the lancet of Fig. 85, with a portion of its sleeve cut away to reveal its interior structure;
• Fig. 88 is an ejection locking member in accordance with an alternative embodiment of the lancing device of Fig. 51 ;
• Fig. 89 is an isolated perspective view of the ejection locking member of Fig. 88 in relation to the lancet carrier and an ejection actuator;
• Fig, 90 is partial top plan view of the carriage assembly of Fig. 5 i in which the ejection locking member of Fig. 88 has been installed;
• Fig. 91 is an isolated perspective view of the carriage assembly and ejection locking member of Fig. 90. showing the ejection locking member forced into iis open position by the ejection actuator of Fig. 89; mid
• Fig. 92 is an isolated perspective view of the carriage assembly and ejection locking member of Fig, 90, showing the ejection locking member in its closed position after the ejection actuator of Fig. 89 has been slid forward,
• Figs. 93a-c art- front-view perspectives of the sleeve sviih a cross section that is one of ovular, circular, and polygonal.
• a lancing system 100 in accordance with an embodiment of the invention is illustrated, including a lancing device 102 and removable lancet 104.
• lancing system 100 is operated by a user to draw a sample of blood or other H bodily fluid from the body such as for diagnostic purposes.
• Lancing device 10? includes a housing 106 with a skin-engaging cap J 08 having a piercing aperture 110, a cocking handle 112 used to cork an internal firing mechanism (described below with reference to Figs ⁇ Ga-BOd). a tiiggej 114 ioi filing the internal firing mechatnsim and an ejection slide 1 15 to eject lancet 104 Iron i lancing device 102 after use,
• Lancing device 102 includes an alternative sue testing ⁇ % "AS1 "') mode actuator ring 1 16 « a user- actuated assembly or user controlled actuator which the user may rotate to switch lancing device 102 from a linger mode (in which lancing device 102 is well-suited for drawing blood from the user's fingertip) to AS f mode (in which lancing device 102 is well suited for drawing blood from part of a user ' s body other than a fingertip).
• Lancing device 10.
• ⁇ sci may rotate to limit fhe forward axial movement of lancet 1 04 relative to the skin-engaging surface of cap 108, and thereby limit the depth that lancet 104 penetrates a user ' s skin.
• Uneet 104 includes a needle 1 1 8 whose length
• a removable tab 124 includes a flange 126 and an elongated stem 128 that encases the shaip tip 120 of needle 118.
• Stem 128 is frangibly attached to ihe front end oJ lancet body 122.
• ⁇ sleeve 130 slides axially over a portion of tht lancet body 122 between forward position (as shown in Fig. S), in which it pr ⁇ tecfivt'ly surrounds the sharp tip 1 ⁇ 0 of needle 1 18, and a rearward position (as shown in Fig. 6) in which a portion of sharp tip 120 protrudes beyond the from end of sleeve 130, [00128]
• the genera! opeiation of lancing system 100 is illustrated in Pigs 7a ⁇ 7d.
• Fig. 7a the user inserts lancet HM into lancing device 102 through picicing aperhne I 10 Removable tab 124 (shown in Fig 7a with phantom lines seen through the user's thumb) provides a convenient finger-grip white also protecting the user from exposure to sharp tip 120 and maintains the sterility of the sharp tip 120
• Linciug device 102 ma> also be cocked by pulling eoekmg handle 1 12 (sec Hg. 1 K Hie mechanisms lor eoc king lancing device 102 arc explained below .
• eoekmg handle 1 12 sec Hg. 1 K Hie mechanisms lor eoc king lancing device 102 arc explained below .
• removable tab 124 extends from piercing aperture 1 10, Referring to Fig. 7b, the user then twists die removable tab 124 to sever it from lancet body 122 along their frangible connection and pulls removable tab 124 off of sharp tip i 20. /Vf this time, sharp tip 120 is enclosed within cap 108.
• lancet 104 can be enclosed by cap 108 of housing 106, so that no part of lancet 104 protrudes beyond piercing aperture 1 10 by an amount sufficient to displace the user's skin from the skin engaging surface of cap 108.
• ejection slide 115 on the underside of housing 106 in the direction of arrow A to partially eject lancet 104 through piercing aperture 110 of cap 108,
• the mechanisms for ejection are described below with reference to Figs. 45 and 46.
• the ejection slide engages an ejection actuator 121 inside housing (shown in Fig. 7c with phantom lines; see also Figs. 45 and 46) to push lancet sleeve 130 into its forward position relative to lancet, body 122 so that lancet sleeve 130 surrounds sharp tip 120 in a protective closure (as shown in Fig.
• lancet sleeve 130 projects out of piercing aperture 1 10 for withdrawing engagement by a user's finger tips.
• Lancet 104 can also be expelled from lancet device 102 by force of gravity after operation of ejection slide ' 1 15, without the user having to touch lancet 104.
• j 00133] As shown in Fig. 7d, grasping the lancet sleeve 130, the user .removes lancet 104 from lancing device 102.
• lancet sleeve 130 is locked into its protective position by the extension of locking members or wings 132a, 132b from lancet body 122 (as shown in Fig. 5), thus reducing the possibility the a user will accidentally prick himself or herself on sharp tip 120.
• Lancing system 100 can also be used in a kit which includes test strips and an analyzer. After lancing system 100 is operated to draw blood, the user applies the bead of blood to the test strip and inserts the test strip into the analyzer for assessment of blood composition; such as levels of glucose.
• Lancet [00135] Referring to Figs. 8-16, the construction of lancet 104 is described, beginning with lancet body 122. Guidance ribs 134 are formed on the top and hoi torn sides of lancet body 122 near its front end. Guidance ribs 134 extend radially from lancet body 122, with the elongated extent of guidance ribs 134 running parallel to the major axis of lancet body 122. [00 ! 36] The diameter of lancet body 122 tapers to form a conical rear end 136 and a neck
• Wing wells 142a and 142b are formed in left and right lateral surfaces of lancet body 122, respectively, near the mid-section oflancet body 122. Extending from each wing well 142a, 142b is one of locking members, or wings 132a, 132b. Each of wings 132a, 132b has a short, stiff base portion 144 extending radially out from lancet body 122 and a planar flexion member 146 having a wingtip 148 extending in generally forward direction but at an acute angle, which in this case is illustrated as approximately 45" away from the major axis of the lancet body 122 when in the extended configuration. Wings J 32a, 132b may be molded as part of lancet body 122.
• Wings 132a, 132b can Hop into a retracted configuration by folding planar flexion members 146 from their extended position shown in Fig. 8 to a retracted position in which flexion member 146 is folded forward by approximately 45" so that flexion member 146 is substantially disposed within its corresponding one of wing wells 142a, 142b.
• Planar flexion members 146 are flexible and resilient in that they can be folded into wing wells 142a, 142b under the influence of a lateral force, but will return to their outward extended configuration when that force is removed.
• Figs. 10-16 illustrate lancet sleeve 130 in more detail.
• Sleeve 130 is generally tubular in construction with a front end ISO and a rear end 152 and defining an elongated inner chamber 154 there between.
• Sleeve 130 is divided into a front portion 156 ami a rear portion 158, Four outer guidance ribs 160a through 16Od project radially from the front portion 156 of sleeve 130 at 90" intervals, extending along the longitudinal extent of front portion ⁇ 56, Front ends 162a through 162d of guidance ribs 16Oa-- 16Od have a slight bevel.
• sleeve 130 is tubular, sleeve 130 can be made with different sectional shapes or slots (to reduce Die material used to manufacture sleeve 130).
• the sleeve 130 has a cross section that is one of polygonal, circular and ovular, as shown in Figs. 93a-e.
• annular flange 164 circumscribes sleeve 130 between its front portion 156 and rear portion 158, 'File front face of annular flange 164 defines a mounting shoulder 166 and the rear face of annular flange 164 defines an ejection shoulder 168.
• mounting shoulder 166 provides a surface permitting a receiver 170 (see Fig. 17) that is interna! to housing 106 to engage sleeve 130
• ejection shoulder 168 provides a surface for ejection actuator 121 (also internal Io housing 106; see Figs. 17 and 18) to engage sleeve 130.
• sleeve 130 is generally hexagonal in cross section (except for its rear end 152, as explained below) and defines lower planar faces 172a and 172 f, upper planar faces 172c and 172d and lateral planar faces 172b and 172e. Lateral planar faces 1 72b and 172e can be used during manufacturing to position sleeve for installation on lancet body. Also, as explained below, when lancet 104 is inserted into receiver 170, lower planar faces 172a and 172f and upper planar faces 172c and 172d mate with corresponding surfaces inside receiver 170 to orient lancet 104 within lancing device 102, as shown in Fig, 42.
• the exterior shape of sleeve 130 at its rear end 152 is that of a cylinder 174 with its top and bottom surfaces sheared off to form planar surfaces 176a and 176b, Planar surfaces 176a and 176b are contiguous with lateral planar faces ⁇ 72b and 172e, respectively.
• Lower planar surfaces 172a and 172f terminate in beveled corner 178a on the left side of cylinder 174 and upper planar surfaces 172c and 172d terminate in beveled corner i 78b on the right side of cylinder 174.
• Beveled corners 178a, 1 78b act. as guiding surfaces to rotate lancet sleeve 130 into its proper orientation as it is inserted into receiver 170.
• inner chamber 154 is generally cylindrical with upper and lower grooves 180 extending longitudinally through sleeve at the top and bottom of inner chamber 154, respectively. Grooves 180 arc each sized and positioned to receive guidance ribs 134 of lancet body 122 in sliding engagement. As best seen in the sectional view of Fig. 16, each of grooves 180 extends from front end 150 of sleeve 130 to one of backstops 1 S2 that are displaced from rear end 152 of sleeve 130.
• wings 132a, J 32!> aie in the extended configuration their wingiips 148 span a distance greater than the diameter of inner chamber 151, If sleeve 130 moves reaiward iclative to lancet body 122 lrom its protective extended configuration (shown in Figs, 5 and 13), wingtfps 148, if extended, will engage ⁇ w rear end 152 of lancet skeve 1 30, blocking iuithei rearward movement of bleeve 130 and in etfect locking sleeve 130 in its protective extended position, as shown its Fig 5.
• Sleeve i 30 and wings 1 32a, 132b can be separate components, as shown above, so fiidt sleeve 130 can be in space apait relation to wings 132a. 1 32b fhis pemu ' ts sleeve to be moved over a wider range of lancet bod> 122 to accommodate operation of lancing device 102 in AS r and finger modes, as described below,
• Receiver 170 is coupled to ⁇ S1 mode aUuatoi ⁇ tu? 1 16 and engages lancet sleeve 130 to move lancet bleevc in response Io movement of AST mode actuator ring ! 16.
• a slidable lancet can ici 208 engages lancet body 122,
• a drive sprmg ? 10 propels the lancet carrier 208 toward piercing aperture 110 to drive lancet needle 1 18 to pierce the user's skin or other bodily tissue.
• a return spring 212 piopels lancet carrier 208, icmoving needk't. ;>haip tip 120 out uf the user ' s skin aftci piercing
• the combination oi lancet carnet 2OK and at least drive spring 210 acts as a lancet holding assembly to hold am! move lancet.
• An ejection aetuaios 121 is coupled to ejection slide 1 15 and ejects lancet 104 from lancing device 102 in response to movement by the ut>ei of ejection .slide ) 15. Also located within housing arc poitions of cocking handle 112 and depth adjuster 1 17 as described below.
• housing 1 Qb [001 ⁇ j Fi ⁇ s. 20 and 21 illustiatc the construction of housing 1 Qb.
• i lousing 106 defines an elongated hollow band having a front aperture 200, rear aperture 201, AST mode actuator aperture 202 (through which a poiiion of AST mode actuator ring 1 16 extends and ti ⁇ gg ⁇ aperture 203 (thi ⁇ ngh which a portion of trigger i 1-1 extends)
• housing 106 may be formed of ⁇ conjoined left half 206 and right half 204 as shown in Figs. 20 and 21 , respectively.
• left hall 706 of housing 106 includes a pair of elongated, spaced -a pail guides 214 defining there between a lancet carries left-hand guide tiack ? 16.
• Left half 206 also includes near its li ⁇ nt end a pah of scnn-annular flanges 21 Sa,
• Flanges ?18a define the left half of shouldeis 220 that are spaced apart shghliy more than fhe width of ASI mode actuator ring 1 16, so ⁇ hat AN F inude actuator ring ⁇ 16 can be mounted for rotation between shoulders 220 oi housing 106, as shown in Fig. 18, The front most of flanges 218a also defmes the left half of fumt apeHuie ?00 of housing 106.
• elongated slot 222 13 fb ⁇ ued near the lower ⁇ ont end of left half 206 - ⁇ s explained below, elongated slot 22? provides a guide track ioi ejection actuates 121 as it slides axially to cjtvi lancet 104 from lanem ⁇ device 102 and also permits intereoi ⁇ liiig of ejection slide 1 1 *> -and ejection actuator 121 lhiough housing 106, Adjacent to ami lust above elongated slot 222 is an elongated member 2?4 that functions as an additional guide Jor the movement of ejection actuator 121.
• kit half 206 has a rediu ed diameter to deli 11c a semi- annular ivm flange ??6a horn which extends the lelt half of a distal mounting poi don 228.
• cocking handle 1 12 and depth adjustment ring 1 17 aie mounted to distal mounting portion 228 Near the rear end of distal mounting portion 228 is a semi -annular flange 23Oa defining the left half rear aperture 201, which has ⁇ J diameter narrower than the tost of mounting portion 228 t ⁇ provide an arumlai guide i ing ibr cocking handle 1 12.
• right half 204 of housing 106 includes a pair of elongated, spaeed-apan guides ⁇ M running along ⁇ - ⁇ p ⁇ nion of the upper longitudinal extent of light half 204. Spaced apart guides 234 define there between the lancet carrier right-hand guide track ?36.
• Right half 204 also includes near its iiont end a pair of semi -annular flanges 218b aligned with flanges 218a of left half 206.
• Flanges 218b define the right half of shoulders 220, as t'Xpiained above in reference to left half 206.
• i'lse (roni-most of flanges 218b also defines the fii_'ht half of front aperture 200 of housing 106.
• An elongated slot 240 for ejection slide 1 1 *> and ejection aetuatoi 121 is formed near the lower Iro ⁇ t end ol right half 204. Slot 240 is in alignment with and performs the same function as its counter-part slot 222 ⁇ Cleft half 206,
• drive spring stop 250 Positioned forward of and slightly above drive spring boss 244 is a drive spring stop 250 in the form of a finger. Positioned rearward of and slightly above return spring boss 246 is return spring stop 252 also in the form of a finger The operations of drive spring slop 250 and return spring stop 252 are explained below iti reference to Figs. 30 f ⁇ th ough 30d. 100163] Positioned near the upper cud of right half 204 just rearward of trigger aperture
• 201. is an open-ended cylindrical trigger pivot well trigger 1 14 is pivotal])- mounted as described below in reference to Figs 27 through 29.
• a rearward poi tion of light half 204 has a i educed diameter to define a semi- annular scar flange 226b from which extends the right half ol distal mounting portion 22 ⁇ H.
• the tear end of distal mounting portion 228 is a semi -annular flange 230b defining the right half of rear aperture 201 of housing lOd, Cap
• Cap 108 may be opaque (so that users do not see ihe sharp tip 120). Cap 1 08 piovides protective closure around sharp tip 120 when lancet 104 is inserted mto laneiug device 102. Referring to Fig. 31 cap 108 also includes an annular skin-engaging proximal surface 254 that forms a compression ring 256 about piercing aperture 1 10. Although cap 108 may be constructed in a variety of sizes and configurations, in certain embodiments piercing aperture 1 10 maj bo about ⁇ mm to about 1 * ) mm in diameter and skm- comniesMon ring 256 may have a width ol about 1 mm io about 3mm.
• Cap 108 can be removable from the front end of housing 106 io permit cleaning of the interior of hnsetng device ! 02. Io permit its removal, cap 108 can be threadably connected to housing 106 or connected via snap fit, for example However, daring operation of lancing device 102 it is not necessary to remove cap 108 Alternatively, cap 1 OS can be permanently attached to or integrally molded with housing 106.
• Lancet 104 can be loaded into lancing device through piercing aperture 110 while cap 108 iemains attached to housing J 06 As explained below, the same cap 108 can be used when lancing device 102 is operated in both finger mode and AS Y modi;. In other words, cap 108 need not he replaced to accommodate use ot lancing device in finger and AST modes. Lancet Carrier
• lancet carrier 208 has the primary function of holding lancet 104 as lancet 104 is inserted, fired and ejected front lancing device 102.
• L ancet carrier 208 includes a main body 258 defining at is front end a mouth 260 comprised of an uppei jaw 262, and a lower jaw 264.
• Upper and lower receiving jaws 262 and 264 are fo ⁇ nt-d of ilexiblc elongated planar members extending torwasd fio ⁇ i main body 258 of lancet carrier 208.
• each of upper and lower jaws 262 and 264 include one of rw ⁇ opposing inwardly projecting snaps 16%. Unless a force is applied io urge jaws ") 62 and 264 apart, jaws 262 ⁇ i ⁇ 2o4 will tend to remain m the closed position shown in Figs. 22 and 1 ⁇
• distance d between snaps 268 is less than the diameter of the mounting bnlb 140 of (he lancet body 1 2l. It will be ap ⁇ itciated that lancet earner 208 operates as pan of a lancet holding assembly that engages the lancet needle at a position that is independent of the position of receiver 170.
• lancet body 122 extends through receiver 170 until its conical rear end 136 abuts mouth 2.60, 1 he distal tip of conical rear end 1 ⁇ o Is sufficiently na ⁇ ow to slide easily between the snaps 268 of upper and lower jaws 262, 264
• portions of conical rear end 136 having a wider diameter enter mouth 260 and force apart upper and lower jaws 262, 264 until the mounting bulb 140 of body passes through jaws 262, 264, Once mounting bulb 140 passes, jaws snap shut around neck 138, whose narrower diameter creates a recess thai engages snaps 268.
• Lancet carrier 2OS will thus hold lancet body 122 until a sufficient forward force is applied to expel lancet body from mouth 260.
• a push plate 270 extends from main body 258 near in the rear of mouth 260 so that push plate 270 abuts the tip of conical rear end 136 of lancet body 122 when lancet body 122 is fully inserted into mouth 260.
• top surface 272 of lancet carrier 208 has an intermediately positioned recess 274 that defines a backwall 276.
• top surface 272 provides a platform 278.
• Recess 274 and platform 278 provide surfaces by which trigger i 14 engages lancet carrier 2OH, as described below.
• a carrier drive spring engagement boss 280 and carrier return spring engagement boss 282 extend from the let! side of lancet carrier 208.
• Carrier drive spring engagement boss can extend out from push plate .270.
• bosses 280 and 282 engage drive spring 210 and return spring 212, respectively, during the firing of lancing device 102.
• Drive spring engagement boss 280 has a rounded contour on its rearward-facing side.
• Return spring engagement boss 282 has a rounded contour on its forward lacing side.
• An elongated horizontal slot 284 is provided in rearward half portion of lancet carrier 208, below platform 278, Slot 284 defines horizontal sidewalk 286 and 288, a back wall 290 and a front wall 292, ⁇ s will be explained below with reference to Figs, 30a through 30d, slot 284 receives engagement members of cocking handle i 12 and depth adjustment ring 1 17.
• Carrier drive and return spring engagement bosses 280 and 282 are disposed within lancet carrier right-hand guide track 236 in housing 106 ⁇ see Fig. 21 ) to permit lancet carrier 208 io slide axial Iy within housing 106 along guide track 236.
• ⁇ guide boss 294 extends laterally from the left hand side of lancet earner 208 just below recess 274 (Fig. 20).
• Guide boss 294 engages lancet carrier left, hand guide track 216 in housing 106 (See Fig. 20) to permit lancet carrier 208 to slide axially within housing 106 along guide ⁇ rack 216.
• the axial sliding movement of lancet carrier 208 within housing 106 pen nits lancet carrier (and thus lancet) to be moved under the operation of drive spring 210 to effectuate the cocking, firing and skin-piercing operations of lancing device 102, as described below.
• JOOl 74 j Referring to tigs.
• a drive member has a di ivts spiing 210 torsion spiing mounted about drive spung boss 244 ⁇ i Lousing 106.
• ⁇ iirsi tciminus of drive spiing 210 fcums a tine 300 ihat engages the iounded contour of drive spring engagemeut boss 280, The opposing terminus of drive spring ?.10 io ⁇ im a line ⁇ )2 that is received by drive spring retention notches
• ietum spiing 212 is a toision spring mounted about rctuui spring boss 246 extending from housing 106.
• ⁇ ikst terminus of return spring 212 is a tine 306 that engages the touuded contour of a return spjing en g agement boss 282 on the lancet carrici 208.
• 1 he opposing terninim of return spring 212 is an anchor tine 308 that is engaged return spiing stop 2b2 extending horn housing 106.
• ieturu spring 212 When ieturu spring 212 is tenstoned fas described below), it suges lancet ca ⁇ iei 2OR awa> from piercing apcrtuie 1 10 to tetract the sharp tip 120 ffoin the usei's skin.
• cocking handle 1 12 has a generally cylindrical handle portion
• cocking handle 1 12 is located o ⁇ er rear end of housing 106, with elongated rod 314 passing into the intenoi of housing i ⁇ through rear aperture 201. Flie constricted diameter of reai aperture 201 restrains elongated rod 3 14 to axial movement within housing 106.
• a compression spring (not shown) may be placed at ieai apciture 201 of housing
• trigger 1 14 has an elongated body 318 with opposing kitcially extending pivots ⁇ 2U
• a user- t jet!?ated ti iggei button 322 is located at the front end of elongated body 31 H, ⁇ tooth 324 depends from the reai end of elongated body 318 and engages the top of lancet carrier 208 as shown in Fig. 2,%.
• Trigger ⁇ 14 is mounted to the housing 106 with the trigger button 32? extending tln ⁇ ngh tiiggci aperture 203 in housing ⁇ )U (see Fig 29a) and each of pivots 320 mounting to one of wells 2 ⁇ 3 formed m the intenoi of housing 106.
• Trigger button 322 includes a colored band ⁇ 25 csi curasc ⁇ bing the bottom portion of t ⁇ igger burton 322 and can ha Vu- a color that contrasts with the color of fhc iemaiuder oi triggei button 322.
• trigger button 322 can be black with a colored band 325 that is red.
• Colored band 325 is visible to a user when the trigger button 322 extends fully through trigger aperture 203.
• Colored band 325 is at least partially obscured from the user's view by the housing 106 when trigger button 322 does not fully extend through the trigger aperture 203, as shown in Fig. 29.
• other indicia may be used instead of a colored band, including for example graphics or alphanumeric symbols, which are placed along the bottom portion of trigger button 322.
• a biasing leaf element 326 extends from the rear end of trigger 1 14 and urges downward the rear end of elongated body 318 so as to urge tooth 324 toward lancet carrier 208 and, in see ⁇ saw fashion, urges trigger button 322 upward.
• trigger button 322 By pressing trigger button 322 down, the user can overcome the force of biasing leaf element 326 and swing tooth 324 upward away from lancet carrier 208 to fire lancing device 104 when cocked.
• Figs, 29a. and 29b the position of trigger 114 relative to housing 106 is illustrated when lancing device 102 is in its cocked and uncocked positions, respectively.
• trigger button 322 extends through trigger aperture 203 in housing 106 so that colored band 325 is visible to user, to provide both tactile and visual feedback to the user that lancing device 102 is cocked.
• Fig. 29b when lancing device 102 is uncocked, trigger button 322 is withdrawn so thai iL docs not extend through trigger aperture 203 and the top surface of trigger hutton 203 is even with the surface of housing 106. In this position, colored band 325 is not visible.
• trigger button 322 is withdrawn atid colored band 325 is not visible, the user has both tactile and visual feedback that lancing device 102 is not cocked,
• Lancet carrier 208 can. have three principal positions relative to drive spring 210 and return spring 212: the neutral position (Fig. 30a), cocked position (Fig. 30c), and the extended firing position (Fig. 30d).
• lancet carrier 208 in its neutral position, lancet carrier 208 is positioned so thai both drive and return springs 210 and 212 are in a relaxed state.
• the neutral position is the position that lancing device 102 returns to alter it has been fired.
• tooth 324 of trigger 1 14 rests on platform 278 oi ' lancet carrier 208 (as also shown in Fig. 29b). This forces trigger button 322, in see-saw fashion, to withdraw from the trigger aperture 203 in the housing 106 so that trigger button 322 cither (lush with exterior of bousing 106 or can extend only partially outside housing 106. In either case, colored band 325 on trigger button 322 is not visible to the user, as also shown in Fig. 2%. [00186] ⁇ n the neutral position, cocking handle 1 12 is at rest on the rear end of housing
• cocking rod 3 i 4 is ful Iy extended into housing 106 and cocking hook 316 is disposed in slot 284 some distance removed from backwall .290.
• cocking handle 1 12 the user cocks lancing device by pulling cocking handle 1 12 away from housing.
• cocking handle 1 12 As cocking handle 1 12 is pulled, cocking rod 314 is drawn in a rearward direction through rear aperture 201 and cocking hook 316 slides rearward through slot 284 until cocking hook abuts backwall 290.
• cocking book 316 abutting backwall 290, continued pulling of cocking handle 1 12 pulls lancet carrier 2.08 rearward relative to its neutral position so that drive spring engagement boss 280 pushes tine 300 of drive spring 210 into a tcnsioncd or cocked position.
• bias leaf 326 pushes tooth 324 into lancet carrier recess 274, it urges trigger button 322 upward in the direction of Arrow A to fully extend through trigger aperture 203.
• colored band 325 about the base of the trigger button 322 is visible to the end user to indicate thai the lancing device 102 is cocked, as also shown in Fig. 29a,
• the force of biasing leaf 326 is overcome, and tooth 324 swings upward (in the direction of arrow C) out of recess 274 in lancet carrier 208.
• carrier 208 is no longer restrained and it accelerates forward under the force of drive spring 210 toward its extended piercing position as shown in Fig. 30c.
• lancet carrier 208 is shown in its extended piercing position after having been fired (that is, released from its cocked position) by the user's actuation of trigger 1 14.
• drive spring 210 by action of tine upon drive spring engagement boss 280 ⁇ not shown)
• sharp tip 120 protrudes momentarily from the piercing aperture 1 10 in the cap 108 to pierce the user's skin.
• lancet eairier 208 can also be cocked by insertion of lancet
• lancet 104 while lancing device 102 is ni AS P mode.
• conical rcai end 116 of lancet body 122 pushes lancet cairiei 208 reamard io its cocked position, where tooth i?4, of
• springs 210 and 212 and trigger 1 14 comprise a user actuated tljive mechanism Any other suitable drive mechanisms can be employed, including for example, coil springs, electromagnetic drives, or unpad hammer airangemeiUs. It will be fttrthet appreciated that the trigger mechanism employed may be any other suitable triggering means, including foi example pulley movement actuated by Totaling oi pulling the lancet device or a sliding mechanism.
• depth adjuster 1 17 the function of depth adjuster 1 17 is to limit the forward axial movement of sharp tip 120 relative to the skin- engaging sm faee 254 of cap 108, and thereby limit the depth that sliatp tip 120 penetrates the nsei s skin.
• the exterior oJ depth adjusunent ring 330 is accessible to users for rotation and includes mdicta 33S and a knob 3 W to facilitate nifinipulatinn by the user. As depth adjustment ring 330 rotates, indicia 138 aj e VISIW L io the use* to indicate the resulting depth setting.
• Depth adjuster 1 1 7 also includes a depth adjustej aet ⁇ atoi 340, which has an i ⁇ eneiallj 7 -shaped chassis V42
• a finger 344 projects from tl ⁇ reas end of /-shaped chassis U2 and is sized to fit in threads 332,
• a guide surface 346 extends from an intermediate portion of Z- shaped chassis 342,
• a depth stop 348 projects from the forward end of Z-shaped chassis.
• depth adjustment actuator 340 moves axially forward and rearward (depending on the direction that depth adjustment ring 330 is rotated). This motion in turn causes depth stop 348 to slide forward and rearward relative to slot 284 (depending on the direction that depth adjustment ring 330 is rotated). The motion of depth adjuster actuator 340 is limited by the length of slot 284 or alternative])/ by the length of threads 332. There is now a pair of stops that limit the rotation of the ring 330,
• Guide surfaces 346 and depth stop 348 slide along adjacent planar parallel guide surfaces 350 and 352, respectively, extending from housing 106 (see Fig. 20) interact to limit motion of depth actuator 340 to axia! (as opposed to lateral) movement.
• drive spring 210 propels lancet carrier 208 forward to extend sharp tip 120 through piercing aperture 110 and into the user's skin.
• depth stop 348 remains stationary so that eventually the back wall 290 of slot 284 will impact depth stop 348, as shown in Fig. 30d.
• Lancing device 102 operates in. AST mode and finger mode. In AST mode, lancing device 102 is configured for use with fleshy parts of the body such as a thigh or forearm. In finger mode, lancing device 102 is configured for use with a fingertip, [00205] Referring to Figs. 31 and 33, operation of lancing device 102 in an AST mode is shown, In AST mode, cap 108 is placed against a fleshy part ⁇ f the body. Compression ring 256 engages tlie user's skin, causing it to pucker inside the relatively wide piercing aperture 110. The puckered flesh is then pierced by sharp tip 120, as shown in Fig.
• fmnt end 1 50 of sleeve 130 is interposed in ⁇ r obstructs a poition or piecing aperture 110, providing in conjunction with compression ring 256, a skin- engaging contour that is suitable for placenieut against a finger.
• the obstruction of (lie piercing aperture 1 10 that is effected b ⁇ sleeve 130 need not be complete; iather sleeve 130 can be placed in pimimity to piercing apeiture 1 i 0 so thai the user ' s skin will eucouiitei sleeve 130 when cap 108 is placed against the user ' s body prior to iuing lancing device 102, and consequently, the user ' s skin will not be able to packet info cap 108 through piercing aperture 1 H), fit least to the same extent as the skm could pucker if sleeve i 30 were not obstructing piercing aperture 1 10, When sleeve 130 obstructs piercing apeiture 1 10, front end 150 of sleeve 130 can be substantial!) copknar with compression ring 256.
• sleeve 130 is held by receiver 170, which in turn is controlled in cam-like fashion by AS f mode actualoi ring 116. ! " o transition between AST and finger mode, the user i dates ASI mode actuator iing 1 16, which drives the receiver 170 (and hence the lancet sleeve 130) axially toward or away from the skin-engaging surface 254 of the cap 108 (depending on which direction the user rotates ⁇ S ' l mode actuator ring 116).
• AS T mode actuator ring 116 operates as a user- actuated assembly or usei -control led actuator to transition the lancing device between finger mode and AS f mode by moving sleeve 130 into d fnsi or forward position where it obstiucts pierdug aperture 1 10 au ⁇ a stixmd or rcai wai d position where sleeve 1 W is withdrawn from pieicing apeiture 1 10 so that sleeve 130 no longer impinges on the user's skui when cap 108 is placed into contact with the user piioi to firing lancing device 102 Alternatively sleeve 1 *0 tan prouude forward past the skin contacting surface o( cap 108.
• Hie effective si/e of the pjeicing apei lure 1 10 can be used as well.
• ihe sleeve 130 can be mounted to the housing 106, as opposed to thi: lancet 104, oi the- skin engaging cap 108 can be deformed.
• AH r mode actuator ring 1 16 is shown in more detail in Figs. ⁇ S 37.
• AS l mode actuator ring 116 is a semi -circular body rotalab ⁇ y mounted m homing 106 between shoulders 7 ⁇ 0 ⁇ F'g. 20) AST i node; actuator ring 1 16 includes left and right semi circular portions 356 and 35X each terminating in clasping ends 3 ⁇ Q and 362, respectively
• the dianscter of ⁇ S V mode actuator ring 116 is sized to permit it to he seemed about lecem-r 1 70 as shown in Fig.
• AST mode actuator ring J 16 includes two opposing bosses 364 and 366, each oi left and right semi-circula* poitior ⁇ 3, ⁇ 6 and 358. iCspectiveSy. Each boss 364 and 366 is sized to engage corresponding cam trails 368 and 370 on receiver 170 (sec Figs. 38 and 44), so that rotation of AST mode actuator ring i 16 will selectively position leceiver 1 70 (and tlms lancet sleeve) axially forward and axiaiiy rearward, depending on which direction AST mode actuator ring 1 16 is rotated.
• Receiver 170 is disposed within housing 106 to allow axial (but not rotational) raanei ⁇ ers,
• a user at mated member in the lbim of control member >72 extends from the AST mode actuator ring 1 16 thiough AST mode actuator apciiure ?U2 in the housing 106 to ptovide a user interface for manipulation oi ASl mode actuator ling 1 16 by the usei.
• the user has adjusted the effective size of the picicing aperture 110 to the chosen diameter when a portion of the AST mode achiator i mg 1 16 is positioned in visual association with the indicia Because control membui ⁇ 12 is captured m AS F mode actuator apertme 202, the M ?
• AS T mode actuator apertme 302 defines the iange that the user can rotate ⁇ S I mode actuator ring 1 16
• Other uwer inicdaues can be employed, including iexhued gripping sus iaces
• AS F mode ⁇ cruator aperture 202 is formis a slot having lafcial ends that deime a path of travel there between Un contioJ niembui 37? ! he shape of aperture 202 may be varied to ovoid, rettiliticai or other suitable shapes,
• indicia 376 is a diagram of a human body, conveying to the user the fact that in ⁇ S ⁇ mode landng device 102 can be used to draw bodily fluid from tissue other than a finger, other symbols or icons may be used.
• indicia 376 con be located o ⁇ ASl modi; actuator ring 1 16 so that indicia 376 is visible through ⁇ S1 mode actuaioi apeituic 202 when AS F mode ⁇ ctualoi ring ) 16 has been rotated to switch lam ing device 102 into ftngei mode.
• Aha natively, two indicia can be used, one to indicate AST mode aud the other to indicate finger mode
• the two indicia nu> be located on the housing
• receiver 170 acts as a sieeve-engagenient portion to ielcasabiy engage lancet sleeve 130.
• Receiver 170 is coupled to AS l mode actuaioi ring 1 16 and eonfsgused to move sleeve 130 in response to the movement of AS 1 mode actuator ring I i 6
• Receiver i 70 is geneially tubular in construction with a cylindrical recetvei body ⁇ 80 deJinmg an elongated Inner chamber 381 therein that is sized and configuied to icceivc lancet 104 as shown in Fig. 40
• Elongated slot 222 runs the longitudinal extent of the underside o( lecerver 170
• cam UaHs 368 and YfQ are cut into the left and right extcrioi sides oi receiver body 380, Cam trad 368 on the left side of receiver body 380 ⁇ tns at a 45 degree angle from vertical from a forward- upper portion of the left exterior side of receiver body 380 to a lowcr-iearvvard portion of the left exterior side of receive* bodv 380.
• l he angle determines the ratio of angular rotation to liueai translation and can be varied to achieve different amounts of translation.
• Cam trail 370 is complementary to earn trail 368, and runs at a forty five degree angle from veHical from a lot ward- lowci portion of the right exterior side ⁇ f receiver bod) 380 to a up ⁇ eweaiwaul portion of the right exterior side of leedver body 380.
• ⁇ S r mode aclnator is clasped about receiver bodv 380 of receiver 1 /0 so that bosses 3ci4 and 366 are inserted into cam trails 368 and J 70, respectively, as shown in Fig. 3ft, ⁇ s AS I" mode actuator ring i 16 rotates riyhtward (that is, ck ⁇ Kwisc when looking at AS F mod?
• Lower guide fine 384 is longitudinally bifurcated by slot 222.
• Fins 382-388 art curved about their respective longitudinal axii to define a portion of the circumference of a circle about the major axis of receiver body 380, as most readily seen in the front view of Hg 42.
• sleeve 130 When lancet 104 is fully inserted into receiver 170, sleeve 130 is disposed in the closure defined by upper and lower guide fins 382, 384 and lateral fins 386, 388, with the rear end 1 52 of sleeve 130 abutting a backstop 389 (Fig. 39) formed in the elongated interior chamber 381 of receiver 170 and in the sectional view of Fig.
• lancet body 122 extends entirely through the elongated interior chamber 381 so that conical rear end 136 of lancet body 122 extends from the rear end of receiver 170 and is engaged by lancet carrier 208, [002 J 9 ⁇ Reinforcements 390, at the rear end of upper and lower guide fins 382 and 384, provide rigidity to guide fins 382 and 384 and to align the receiver within the housing. Lateral fins 386 and 388 do not have reinforcements and arc sufficiently thin so as to have flexibility in response to lateral forces.
• the front tips of lateral fins 386 and 388 include opposing inwardly projecting snaps 392.
• the distance between snaps 392 is slightly less than the diameter of annular flange 164 of sleeve 130, As lancet 104 is inserted into receiver 170, annular flange 164 abuts snaps 392.
• annular flange 164 abuts snaps 392.
• annular flange 164 is clear of snaps 392, lateral fins 386 and 388 (having been pushed apart) urge snaps 392 into clasping engagement with mounting shoulder 166 on the front side of annular flange 164, as best seen in Fig. 18.
• Other suitable means cart be used to couple receiver 170 and lancet sleeve ⁇ 30.
• Elongated interior chamber 381 is configured for mating engagement with the external contours of lancet sleeve 130 and lancet body 1.22. As shown in the cut-away perspective view of Fig. 39, receiver body 380 includes a forward internal portion 400 and a rearward internal portion 402,
• Forward internal portion 400 of receiver body 380 has a diameter sufficiently wide to accommodate the rear portion 158 of sleeve 130.
• Forward interna! portion 400 forms lateral guide wall 404a which has a vertical planar face and upper guide wall 404b which has a horizontal planar face forming a 90° intersection 405 with guide wall 404a in the upper right- band poition of elongated interior chamber 381.
• tig. 42 is a front view of receiver 170 showing in phantom lines a sectional view of lancet sleeve 130.
• a pair of guide walls 404c and 404d can ha piovided in the lower left-hand portion of elongated chamber 381 io engage the pair of planar surfaces 172 that are opposite the pair ol planar surfaces engaged by guide walls 404a and 404b, It will be seen in Fig. 42 that the engagement of one of planar surfaces 172 with walls 404 will rotate the entire lancet fort ⁇ ' five degrees from vertical orientation,
• rearward internal portion 402 of receiver body 380 has a diamond shaped cross section sized to accommodate lancet body 122 and including rear gmritiwall ⁇ 408 Rearward internal portiou 402 is narrowct than forward internal portion 400.
• sleeve 130 When lancet 104 is initially inserted into receiver 170 by the user, sleeve 130 is in its extended protective position and locking inembei wings 132a, 132b are in the extended configuiation Ut engage sleeve 130 and pre ⁇ cut sleeve 1 ⁇ O fiorn sliding toward the rear end of lancet body 122 (as shown in Fig. 5)
• axial movement of lixeivet 170 will cause sleeve 1 30 to slide axially relative io pieicing apcrtuic 110 from its finger mode position (shown in Figs, 31 and 33) to its AST mode position (shown in Figs. 32 and 14 ) while lancet body 122 (and needle 1 I S embedded therein " ) remain in plate relative to piercing aperture J lU. ⁇ t the same time, lancet body 12 ?
• lancet sieeve 130 will impinge on backstop 389 ol receiver 170. so that lancet sieeve 130 (and consequently. lancet bod)- 122), caimot be further inserted.
• lancet sieeve 130 and consequently. lancet bod)- 122
• caimot be further inserted.
• Ihus, llrro mseition ol lancet 104 when Lmeing deuce 102 is in AST mode will cause conical reai end 136 of tancet body 122 to drive lancet cairier 208 rearward into Us cocked position shown in Fig. 30c.
• lancing device can he re ⁇ eoeked by pulling coekiug handle as described abo ⁇ c in reference to Fi 8 Wh.
• AST mode actuator ring 1 16 and receiver 170 function together as an actuator that ieka ⁇ ably engages sleeve 130 to permii the user to sejccth ely move sleeve 130 relative to housing 106 and lancet needle 1 1 8,
• Other mechanisms can be em ⁇ lo) ed the scope of the present invention in accomplish this function.
• a linear switch 460 can be provided which includes a linger 470 extending though a slot 480 in cap 108.
• Slot 480 can be parallel to the longitudinal axis of housing 106, and linger 4 /0 can be coupled to the receiver so that axial movement of finger 170 by the user drives corresponding axial movement of sleeve 130,
• different structuics may be employed to rcleasably clasp sieeve 130.
• the end of linger 470 can include a pair of tines 490 to clasp sleeve 130 aboui annular flange 164. thus translating axial movement of finger 470 to corresponding axial movement of sleeve UU.
• inner chamber 381 of teceiver 1 70 can be sized to hold sleeve 130 in a friction fit
• 2JOCtHHi actuator 121 is shdably mounted within housing 1 06 and includes an elongated mam bod ⁇ 420 having top surface 422 ⁇ finger 424 extends from top surface 422 near the front end of main body 420 into the underside of teceiver 170 through elongated slot 222, whete fmgei 42'! is to the rtar of and the same height as the down most portion of ejection shoulder 168, at, best shown in Fi ⁇ , 18.
• imgei -124 can engage another part ⁇ f sleeve 130, such as its rear end I *>2.
• Iv 1 -O tongues 426 extend laterally and in opposing directions fiom the underside of main body 420.
• Geneva of tongues 426 extends through its adjacent one of elongated ⁇ lofs 240 fo ⁇ neJ m lateral walls oi housing 106, permitting ejection actuator 121 to slide along elongated slots 240 in forward and rearward axiai directions, but otherwise preventing lateral or vertical movement of ejcctiou actuator 121 [00232] 1 ungues 426 projects through sluts 240 and are received by we!
• ejection slide 1 15 is coupled to ejection actuator 121 so movement of one will cause movement of the other [00233]
• ejection slide 1 15 and ejection actuator 1 121 are in their rearmost at rest positions.
• the user slides ejection slide 1 13 forward toward piercing aperture 1 J O from its at rest position. This in turn causes ejection actuator 121 to slide within housing, engaging and ejecting kmcei 104 as described below.
• Ejection actuator 121 operates in conjunction with a locking member 432, is disposed between top surface of main body 420 and lower jaw 264 of lancet carrier 208 The function of locking member 432 is to restrain the jelease oi the lancet body 122 from the upper and lower jawh 2h2, 264 ol the lancet ca ⁇ ier 208 until the lancet sleeve 130 has been fully extended by the ejection actuator 121
• Locking member 432 lias an elongated body 134 having an upper surface 436 and a lower suriate 438. Near its front end -140, elongated body 434 foims an upwardly facing bar 442 and a downwardly facing CO ⁇ VCK surface 444. At its rear end, elongated body 4 ⁇ 4 is pivutally mounted to lancet car ⁇ ei 208 by pivot 446, so as elongated bod) 434 rotates about this pivot, its front end 440 is raised and lowered relative to the lower jaw 264 of lancet cdrriet 208. [00236] Locking member 432 u> aligned iu parallel superposition with ejection actuator
• I op surface 422 includes an upwaidiy-f ⁇ cing concave recess 4 ⁇ 0 sized and shaped to hold the downwardl y lacing convex suiiure 444 of locking member 432.
• convex swface 444 is aligned with and rest 1 -; in concave iecess 4SQ hi this position, bar 442 is clear of lower jaw 264, [00237]
• Figs. 46a through 46d illustrate the operation of the ejection slide 1 15 and ejection actuator 121. After insertion of lancet.
• ejection slide 1 15 and ejection actuator 121 are in their rearmost at rest positions, as shown in Fig. 46a.
• the user slides ejection slide 115 forward toward piercing aperture 1 10.
• the resulting sliding .motion of ejection actuator 121 causes finger 424 to move forward through slot 222 in receiver 170,
• lancet sleeve 130 may exert a force on lancet body 122 due to friction as the sleeve 130 slides axial Iy over lancet body 122. This force has the tendency to pull lancet body 122 out of lancet carrier 208 and along with sleeve 130, thus preventing sleeve 130 from fully extending relative to lancet body 122. Even if lancet body 122 remains engaged, by lancet carrier 208, the forward thrust on lancet 104 may move lancet, carrier 208 forward.
• Locking member 432 restrains the release of the lancet body 122 from the upper and lower jaws 262, 264, thus holding lancet body stationary while lancet sleeve is pushed forward by linger 424, At the same time, it blocks forward movement of lancet carrier 208. J00239] As the user continues to slide ejector 1 1 5 forward, finger 424 moves through the slot 222 in the receiver 170, until it engages ejection shoulder 168 formed in an annular flange 164 of the lancet sleeve 130 (see also Fig. 10 for more detailed view of ejection shoulder 168).
• wings 132a, 132b (which had been folded into wing wells 142a, 142b) are no longer deformed and restrained by rear guide walls 408 of receiver 170, and accordingly wings 132a, 132b flap out into an extended V-shaped configuration (See Fig. 5). in this extended V-shaped configuration, wings 1 32a, 132b engage and prevent sleeve 130 from moving axially rearward and thus exposing sharp tip 120.
• Cap 500 includes a piercing aperture 502, which in this case may be elongated with a enlarged center portion 504.
• Cap 500 has a rigid base 506 which can be opaque, and a skin-engaging cover 508 which is composed of electrometrie material and can be transparent.
• a plurality of small bumps 510 arc disposed about the piercing aperture 502 and are mounted on upwardly extending arms 512 which act as cantilevers. Arms 512 can be mounted to ridged base 506 and can extend upward at an angle (as shown) through the electrometrie cover 508 so that a portion of arms 512. extends beyond the cover.
• Arms 512 are flexible to permit buraps 510 to move toward cap 500 when bumps
• EJectromctrie cover 508 serves to add compliance to the skin as well as to spread the motion of bumps 510 to adjacent skin.
• Arms 512 can include stops or other suitable mechanisms (not shown) to limit inward movement of bumps 510. This permits lancing depth to be more predictable and less dependant upon the force applied to the user's skin. Additional Enubodiment for Depth Adjustment
• sleeve 130 siides through the front end of the cap IOS by the motiou of AST mode actuator ring 116 and receiver 170, as described above. However, cam trails 368 and 370 of receiver 170 are cut to permit receiver 170 to move a greater distance toward cap 108 when AST mode actuator ring 1 16 is rotated. Tn this manner, the front end 1 50 of sleeve 130 can be extended through the piercing aperture 1 10 to provide a skin engaging surface 514 that protrudes from the plane of piercing aperture 110 by a distance "d" as shown in Fig. 50b.
• sleeve 150 extends beyond piercing aperture 1 1 (K it spaces the user's finger away from needle 1 18 and reduces by the distance "d" the length of sharp tip 120 that is exposed to penetrate the user's skin. The farther out sleeve 130 is extended, the less distance sharp tip 120 penetrates the user's skin,
• sleeve 130 is held by receiver 170, which in turn is controlled in cam-like fashion by AST mode actuator ring S 16.
• AST mode actuator ring S 16 To adjust lhe position of sleeve 130 relative to piercing aperture 1 10, the user rotates AST mode actuator ring 1 16, which drives the receiver 170 (and hence the lancet, sleeve 130) axially toward or away from die skin-engaging surface 254 of the cap 108 (depending on which direction the user rotates AST mode actuator ring 1 16).
• actuator ring 116 can operate as a user-operable switch or control to adjust penetration depth by moving sleeve 130 into a first position where it extends beyond piercing aperture 1 10 and a second position (sec for example Fig. 33) where sleeve 130 is withdrawn from piercing aperture 110 so ilia! sleeve 130 no longer impinges on the user's skin when cap 108 is placed into contact with the user prior to firing lancing device 102, AST mode actuator ring can also be rotated to a third position, for example, where sleeve 130 extends beyond piercing apertures i 1 0 by a distance less than or greater than distance d.
• AST mode actuator ring By selectively positioning AST mode actuator ring, the user can achieve a desired depth penetration level, Detents and indicia can be provided on ASiT mode actuator ring 1 16 to assist users in selecting a desired position.
• aitemaiive embodiment of lancing system 100 includes a lancing device 102' and a lancet such as lancet 104.
• Lancing device 102' is similar m construction and operation to lancing devie ⁇ 102, and only those features that are different are described in detail.
• Lancing device 102' is operated by a user to draw a sample of blood or other bodily fluid from the body such as for diagnostic purposes.
• Lancing device 102' includes a housing 106' with a skin-engaging cap 108" having a piercing aperture 1 10" and a cocking handle 1 12' used to cock an interna] firing mechanism (described below).
• Cocking handle i 12' includes an elongated rod 314 * extending into the interior of housing 106' that terminates in an L-sha ⁇ ed cocking hook 3 ⁇ 6 ⁇
• Lancing device also includes a trigger assembly 515 that includes a trigger button
• Housing 106' includes right- and left half portions, 204' and 206', respectively.
• An AST mode actuator ring 116' is provided which operates with a receiver 170' substantially as described above with respect to actuator ring 1 16 and receiver 170.
• a carriage assembly 517 is disposed within housing 106" for sliding axial movement to and away from piercing aperture 1 J (Y. Included in carriage assembly 517 is a slidablc lancet carrier 208' that engages lancet 104, a drive spring 210' that propels the lancet carrier 208' toward piercing aperture 1 10' Io drive lancet 104 to pierce the user's skin or other bodily tissue.
• lancing device 102 can be equipped with other drive mechanisms, such as a coi! spring, a leal " spring, and electromechanical or electromagnetic drive or other suitable mechanisms known in the art to propel lancet carrier 208' axially within housing 106 ⁇
• Lancing device 102' includes a depth adjuster 521 which operates in concert with carriage assembly 517. Aa explained below, the user's rotation of depth adjuster 521 causes carriage assembly 517 to slide axially within the housing 106 ° to regulate penetration depth of lancet 104 when lancing device 102 ' is fired.
• Ejection actuator 516 is slidably mounted within housing 106' and includes an elongated main body 518 with a spine 520 extending upwardly therefrom along the longitudinal extent of the main body.
• Spine 520 includes a finger 522 whose structure and function is the same as that of finger 424 described above.
• Ejection actuator 516 operates in conjunction with a locking member 524 (which is used in place of the locking member 432 described in the previous embodiments),
• Ejection actuator 516 operates in conjunction with a locking member 524 to restrain movement of lancet carrier 208' during operation of ejection actuator 516 as described below.
• Locking member 524 includes a cylinder 526 from which extend upper arm 528 and lower arm 530.
• Upper arm 528 defines an abutment surface 532 near its distal tip.
• Lower arm 530 defines a front surface 534 and a rear surface 536 near it distal end.
• cylinder 526 is mounted to housing to permit rotation about its major axis.
• Lower arm 530 extends from cylinder 526 so that its distal end extends into a notch 538 in spine 520 of ejection actuator 516 when ejection actuator is at its rearward "at -rest” position.
• Notch 338 defines a front wall 540 and rear wall 542 as best seen in Figs, 52b and 53b.
• upper arm 528 is clear of an engagement boss 280' on lancet carrier 208 s , as shown in the top plan view of Fig. 53a. Accordingly, locking member 524 does not in this configuration prevent forward axial movement of lancet carrier 208'.
• ejection actuator 516 engages sleeve 130 to eject lancet 104.
• lancet body 122 is held by lancet carrier 208' by a pair of jaws similar in construction to jaws 262 and 264 described above.
• sleeve 330 moves forward, it may exert a force on lancet body 122 due to friction as the sleeve 130 slides axially over lancet body 122. This force has the tendency to pull lancet body 122 out of lancet carrier 208' and along with sleeve i 30.
• the snap closure of jaws on lancet carrier 208" may be sufficiently stiff to prevent removal oflancei body 122 as lancet sleeve 130 is pushed forward. However, the thrust imposed on lancet body 122 is communicated to lancet carrier 208'. which then has a tendency to move, In the closed position, as shown in Figs.
• locking member 524 engages a boss 280' extending from lancet earner 208' to prevent forward movement of lancet carrier 208 ⁇
• ejection actuator 516 continues to move forward, the distal end of lower arm 530 is thrust out of notch 53 S and abuts a sidewall 544 of spine 520, which prevents rotation of locking member to its open position shown in Fig, 52a.
• FIG. 53b An alternative embodiment in the form of ejection actuator 5Kr and locking member 524' is illustrated in Figs. 59A and 5 C )B, Ejection actuator 516' and locking member 524' operate substantially as described above with respect to ejection actuator 516 and locking member 524.
• Ejection actuator 516' is slidably mounted within housing 106' and includes ati elongated main body 518'.
• Lucking member 52,4' includes a cylinder 526' from which extend upper arm 528' and lower arm 530'.
• Upper arm 528 ' defines an abutment surface 532" near its distal tip.
• Lower arm 530 ' defines a front surface 534' and a rear surface 536' near it distal end.
• Lower arm 530' extends from cylinder 526" so that its distal end extends into a notch 538' in elongated main body 518 " .
• Notch 538' defines a front wall 540' and rear wall 542' as beat seen in Figs, 59B.
• rear wall 542' and rear surface 536' have corresponding convex contoured surfaces
• lancet carrier 208' includes a projection 545 jutting forward to engage abutmeni surface 532' of upper arm 528'.
• the forward end of projection 545 includes a beveled front face 546 that defines a V-shaped contour.
• Abutment surface 532 ' is tapered to engage face 546 so that forward movement of lancet carrier 208 s urges locking member 524' to rotate about cylinder 526' in the direction of arrow E.
• a bias element such as a spring can be included to also urge locking member 524' to rotate in the direction of arrow E.
• a bias element such as a spring can be included to also urge locking member 524' to rotate in the direction of arrow E.
• a bias element such as a spring can be included to also urge locking member 524' to rotate in the direction of arrow E.
• a bias element such as a spring can be included to also urge locking member 524' to rotate in the direction of arrow E.
• a bias element such as a spring can be included to also urge locking member 524' to rotate in the direction of arrow E.
• a bias element such as a spring
• Locking member 547 is coupled to ejection actuator 5 16" by a rod 548 that is pivotally mounted to both locking member 547 and ejection actuator 516 " ⁇ As ejection actuator 516" moves forward in the direction of arrow G during ejection., rod 548 urges locking member 547 away from ejection actuator 5 i 6" and into blocking engagement with lancet carrier 208', it will be noted that, when locking member 547 is blocking the forward movement of lancet carrier 208". substantially all of the forward force imposed by lancet carrier 208' can be borne by the bearing surfaces of guide tracks 549a, 549b, which can be close enough to locking member 547 an lancet carrier 208' to reduce or eliminate torque imposed on rod 548.
• Interlock member 554 prevents lancet 104 (shown in Fig. 6 Ie) from being inserted for operable engagement into lancing device 102' when lancing device 102' is cocked.
• the interlock member selectively prevents the lancet from being operably engaged for use. This feature reduces the chance thai a user will accidentally prick himself or herself while loading lancet 104 into lancing device 102'.
• Interlock member 554 cooperates with a trigger assembly 515.
• trigger assembly 515 operates in substantially the same manner as trigger 1 14 shown in Pigs. 27-30.
• trigger assembly 515 pivots in see-saw fashion so that trigger button 523 moves upward to extend through a (rigger aperture 203' of housing 106 s (shown in phantom lines in Figs 60 and 6 i ).
• trigger assembly 515 pivots in see-saw fashion so that trigger button 523 moves downward.
• trigger button 523 is coupled to interlock member 554 so that when lancing device 102' is cocked, the resulting upward movement of trigger button 523 causes interlock member 554 to swing to an engagement position (shown in Figs. 60b and 61 b) in which interlock member 554 blocks or is interposed into the path of insertion P of lancet 104 to prevent- full insertion of lancet 104 into lancing device 102'.
• the resulting downward movement of trigger button 523 causes interlock member 554 to swing to a disengagement position (shown in Figs. 60a and 61 a) in which interlock member .554 does not prevent the insertion of lancet 104 into lancing device 102'.
• Interlock member 554 includes an elongated main body 556 having a blocking member 558 at its from end and an elongated cylinder 560 at its rear end.
• the major axis of cylinder 560 is generally perpendicular to the major axis of main body .556.
• Cylinder 560 is mounted to bousing 106 ' to permit, cylinder 560 to rotate about its major axis. As cylinder 560 rotates, interlock member 554 swings into and out of its engagement and disengagement positions.
• a resilient cantilever spring 562 extends from an off-center rear portion of cylinder 560 and terminates hi a distal portion 563 thai is spaced apart from main body 556. Distal portion 563 of cantilever spring 562 engages housing 106' in a position that flexes cantilever spring 562 and urges interlock, member 554 to rotate about the major axis of cylinder 560 to move blocking member 558 to its engagement position in which at least a portion of the blocking member 558 is interposed between the front end of the housing 106' and the lancet holding assembly to block full insertion of the lancet 104 into the housing 106 " by blocking the path of insertion P of lancet 104 (see Fig. 61 b).
• blocking member 558 includes two front- facing surfaces 564 and 565.
• Surfaces 564 and 565 fo ⁇ u at) angle Iheiebetwee ⁇ of about 120 degrees; however, othei angles and configurations can be selected,
• a cam follower 5 ⁇ 6 extends upward from main body 556 As best seen in Fig
• cam ioll ⁇ wei 566 includes a vertical base portion 568 and horizontal finger portion 570 extending from the upper end of vertical base portion 568. Finger portion 570 is crowned by a boss 572,
• Trigger button 523 includes a cam trail 574 positioned to admit finger 570 of cam follower 566, as best seen in Figs. 70 and 71 .
• cam trail 57*1 Inside of cam trail 57*1 is a sloped cam surface 576, against which boss .572 engages under the bias foice of cantilever spring 562
• Figs, M a through 61c operation of trigger button 523 (shown in phantom lines) and interlock member 554 is illustrated.
• Fig 6 I a when lancing device 102 " is uncocked, triggej button 523 is in a lowered elevation, forcing rotation of inieri ⁇ dung member 554 to the disengagement position.
• the usei may inseit lancet 101 into lancing device As shown iu Fig. 61 b.
• lancet interlock may be any other suitable interlock means, hit lading for example slidable l ⁇ ekiug means or push tab locking means. It will be further appreciated that the movement of interlock member 55 Z 1 may be actuated by other suitable arrangement and references to such arrangements arc not limited to trigger button 523.
• lancet eairiei 208 can br coupled by cam action to interlock member 554 to urge interlock member 554 out of path of insertion P when lancet earner 208 is moved out oi its cocked position.
• Carriage assembly includes a carriage 580 and a carriage cover 582 suitably connected together to define therebetween s chamber 5&4 in which lancet carrier 208' is captured as seen in Fig. 73.
• Opposing top and bottom poi lions of lancet carrier 208 ' engages planar guide surfaces 58b of carriage 580 to peimit lancet carrier 208' to slide dxiaily within carnage assembly ⁇ 1 7, as setm in Fig. 7 ⁇ . i'igs. 74 and 75 show carnage 580 in more detail, Fig. 77 shows carriage cover 582 in more detail.
• Carriage " ⁇ SO and carriage cover 582 can be connected in an) suitable manner, sueii as by snaps 588 on carriage ⁇ wei 582, Adhesive, screws or other suitable fasteners may also be used.
• lancet earner 208' moves funvard in a piercing action, it engages and tensions return spring 212', which then impels lancet carrier 208 " toward the rear of housing 106 ⁇ thus ieti acting lancet 104 ftom the user ' s skin.
• lancet earner 208' moves funvard in a piercing action, it engages and tensions return spring 212', which then impels lancet carrier 208 " toward the rear of housing 106 ⁇ thus ieti acting lancet 104 ftom the user ' s skin.
• a fixed projection such as a stop 593 located on carriage 580.
• Projection or stop 593 is fixed and is not aligned with or otherwise moved relative to lancet carrier 208'.
• the stop 593 can be located and positioned in any suitable manner such as the Lop bottom, front oi rear ol carriage assembly 517. Note that the position oi projection stop 593 Ls ⁇ xc ⁇ and is not moved oi aligned relative to lancet cairier 208'
• Carriage assembly 517 is slidably disposed with housing 106', which includes a pair of guide tracks 596 on at least the right halt housing portion 204' as shown in Fig, 76, Each of tracks 5% includes stops 598 a, 598b at its opposing ends. Corresponding guide tracks (not shown) may be provided on left half housing portion 206" as well. Projections 600 extending from carriage 580 (see Hg. 75) engage Uack*> 596 and permit sliding axial movement of cairiage assembly 51 7 defined by the distance between stops 598a, 598b.
• Carriage cover 582 includes guide surfaces 602 that engage corresponding structure (not .shown) in the inteiior wall of left half housing poitiou 206 ' to prevent movement of carriage assembly 517 cither than in an axial direction within housing 106 " .
• Carriage cover 582 also includes an aperture 604 to revive boss 502 of carnage 580 and an aperture o06 to receive a boss 608 projecting from carnage 580. Bosses 592 and 608 align and couple carriage 580 and carnage cover 582.
• caiiiagc 580 includes upper and lower members 610a and 610b, respectively Fing ⁇ s 612a and 612b extend in radial! ⁇ - opposite directions from each of upper and l ⁇ wei members ol Oa and 610b, respectively, ⁇ s explained below, fingers 612 ⁇ , 612b engage depth adjuster 521 as shown in Fig. 78A.
• depth adjuster 521 ss to permit useis to adjust the penetration depth of lancet 104 when lancing device 102 ' is fired.
• depth adjuster 521 includes a depth adjustment ring 614 mounted on housing 106' for rotation about the axis of housing 106', 1 he forward interior portion of depth adjustment ring 614 has threads H 3
• Carriage assembly 517 is positioned within housing 106 ' so that fingers 612a,
• sharp tip 120 of lancet 104 extends farther from piercing aperture 1 10' when lancing device is fired, and thus penetrates more deeply into the user's skin.
• carriage assembly 5.17 is moved away from piercing aperture 110'., so that the entire lancet carrier 208' is moved away from piercing aperture 210.
• sharp tip 120 of lancet earner 104 extends a shorter distance from piercing aperture 1 10" when lancing device 102' is fired, and thus penetrates less deeply into the user's skin.
• depth adjustment ring 614 permits the user to adjust the ultimate penetration depth of lancet 104 when lancing device 102' is fired.
• the exterior of depth adjustment ring 614 is accessible to users for rotation and can include indicia 62.0 and a knob 622 to facilitate manipulation by the user. As depth adjustment ring 614 rotates, indicia 620 are visible io the user to indicate the resulting depth setting.
• FIG. 580 * is illustrated.
• This embodiment is substantially identical to the embodiment of Fig. 72, An elongated horizontal slot 284' is provided in rearward half portion of lancet carrier 20S'. Slot 284 defines a rear wall 290". As described above, when a user pulls cocking handle 112', rod 314' draws back cocking hook 31 (>' which engages rear wall 290 ' of lancet carrier 208' to move lancet carrier 208' rearward.
• carriage cover 582" includes an elongated slot 609a to accommodate the distal tip of cocking hook 316 ⁇
• a stop 609b at the rearward end of slot 609a limits the distance that codding rod 3 S 4' (and therefore lancet carrier 208') can be pulled rearward.
• This is advantageous for example, when receiver 170 is mounted to carriage assembly 517', In that case, if lancet 104 is inserted into lancing device 102' with removable tab 124 still attached and then pulls cocking handle, there is a possibility of retracting lancet carrier 208' suftkkn ⁇ ly remward ⁇ o that removable tab ⁇ 2A engages the front end of receiver 170.
• tli ⁇ f engagement of tab 124 with receiver 170 can pi event further rearward movement of lancet 104, resulting hi a disengagement ol laneef 104 from laueei earner 208' as cocking handle 1 12 s draws, lancet ca ⁇ ier 208 " fiuther back ff the stop 609b is placed on carriage assembly S 17' , the distance between slop 609b and receiver 170 is fixed, and therefore it can be assured that cocking handle ⁇ 1 T will nut draw back lancet earner 208' so lar as to disengage lancet 104, If however, a cocking handle stop such as stop 609b were placed an ihe housing it would need Io be sufficiently learwaid to allow cocking through the foil range of positions of carriage assembly 517'.
• a trigger assembly 515 is provided as shown in Figs, *> 1 , 80 and 81 .
• its functions can include holding lancet carrier 208" in. and upon actuation by a user releasing lancet carrier 208 ' from, its cocked position so that drive spring 210 ' can propel lancet cairier 208' forward.
• Trigger assembly 515 includes trigger button '123 which is captured by a txigger aperture 203 ' in housing 106 " and a trigger aim 626 having a front end 628 and a rear end 630 and laterally-oriented mounting aperture 632 therebetween.
• Trigger arm 626 is. mounted by aperture 61? to bow 608 extending from carriage 580 so that trigger arm o26 can ptvot about boss 608 in see -saw fashion.
• aperture t>32 can be loeaied ucar cud of (rigger arm 626, Note that trigger button 52 ⁇ is captured by trigger button aperture 203" so that it cannot move in a longitudinal direction relative to housing 106" as eairiage assembly ⁇ ) 7 is moved by depth adjustment ring 61 4.
• triggei arm (v2 ⁇ is mounted to boss 608 of carnage 580. so that when carnage assembly 5 1 / moves axially within housing 106", trigger arm 626 is also moved axiaiiy with carriage assembly 517.
• Recess ft34 includes interior guide surfaces 633 ⁇ "633d which correspond in mating engagement to guide surfaces 63'w-633d, lespectivejy on trigger arm 626, as best seen in Fig. 80.
• a clip spring 636 or other suitable biasing mechanism is coupled to housing U)(S' and urges the rear end 630 of trigger arm 626 downward and front end 628 upward, so thai trigger button 523 extends through trigger aperture 2Q3 ⁇ In this position, a latch 638 that depends from rear end 630 of trigger arm 626 can engage lancet carrier 208 " to hold it in a cocked position.
• trigger arm 626 pivots so that the front end 628 moves downward and the rear end 630 moves up, effectively tiring lancing device 102' by lifting latch 638 up off of lancet carrier 208' so that drive spring 210" can propel lancet carrier 208 " toward piercing aperture 1 10 ⁇ [00295] Because trigger arm 626 moves with carriage assembly 517, the relative axial position of trigger arm 626 and the front end of lancet carrier 208' can be fixed.
• Trigger arm 626 can be positioned so that trigger assembly 515 goes into a cocked configuration at or just after the time when lancet 104 has been inserted into lancet carrier 208".
• the cocking of trigger assembly 515 occurs after a user has successfully inserted lancet 104 into lancet carrier 208 ⁇ If the cocking of trigger assembly 515 occurs earlier, the user may stop inserting lancet 104 on the mistaken perception that the lancet was successfully inserted. If the position of trigger arm 626 did not move with carriage assembly, then cocking of trigger assembly 515 could occur at different times relative to the insertion of lancet 304 into lancet carrier 2OH' depending on the axial position of carriage assembly 517.
• Lancet 650 includes needle 652 whoso length (excluding a sharp tip 654) is encased in an elongated lancet body 656.
• a sleeve 658 slides axially over a portion of the lancet body 656 between forward position (as shown in Fig, 82), in which it protectively surrounds the sharp tip 654 of needle 652, and a rearward position (as shown in Fig. 83) in which sharp tip 654 protrudes beyond the front end of sleeve 658.
• lancet body 656 includes a pair of locking members or wings
• Wings 66Oa 5 660b may be molded as part of lancet body 656.
• Wings 660a, 66Oh can flap into retracted configuration by folding planar flexion members 670a, 670b from their extended position shown in Fig, 84 to a retracted position in which each flexion member 670a, 670b is folded forward so that each flexion member 670a, 670b is substantially disposed within its corresponding one of wing wells 672a, 672b, as shown in I 1 Ig. 83.
• Planar flexion members 670a, 670b are flexible and resilient in that they can be folded into wing wells 672a, 672b under the influence of a lateral force, but will return to Their outward extending position when that force is removed.
• Sleeve 658 is generally tubular with an elongated inner chamber 674 having a cylindrical contour to receive lancet body 656.
• the cylindrical contour of inner chamber 674 is modified by the inclusion of wing engagement surfaces 678a, 678b, which are a pair of wide, shallow lateral grooves on opposing lateral sides of sleeve interior chamber 674 thai extend the length of sleeve 658.
• wing engagement surfaces 678a, 678b which are a pair of wide, shallow lateral grooves on opposing lateral sides of sleeve interior chamber 674 thai extend the length of sleeve 658.
• sleeve 658 is tubular, sleeve 658 can be made with different sectional shapes or slots (to reduce the material used to manufacture sleeve 658).
• the sleeve 658 has a cross section that is one of polygonal, circular and ovular, as shown in Figs. 93a ⁇ c.
• wings 660a, 660b When wings 660a, 660b are in extended configuration (as shown in Fig. 82), their wingrips span a distance greater than the diameter of inner chamber 674. If sleeve 658 moves rearward relative to lancet body 656 from its protective extended position, wings 660a, 660b, if extended, will engage the rear end of lancet sleeve 658, blocking further rearward movement of sleeve 658 and in effect locking sleeve 658 in its protective extended position. [00301 j I ⁇ owever, when wings 660a, 660b are in their retracted configuration (that is, folded into wing wells 673a, 672b as shown in Fig.
• each of the wings (now folded into wing wells 672a, 672b) brushes along the longitudinal extent of elongated guide surfaces, or wing engagement surfaces 67Sa, 678b, as shown in Fig, 83,
• wings 660a. 660b are made of a ddorniable, resilient material, it is possible in rare cases that if wings 660a, 660b remain in a folded position for along time, they may lose resiliency and therefore not return to Their extended position when lancet 650 is ejected from its lancing device 102 and sleeve 658 is pushed to its extended protected position. This may occur, for example, if lancet i 04 is loaded into lancing device i 02 and is then left by the user without further use for a long period of time, particularly if lancing device i 02 is subject to high temperature. Alternatively, if lancet.
• 650 is used repeatedly (inserted, ejected from and reinserted into lancing device 102), wings 660a, 66Oh may lose resiliency and therefore not return to their extended position when lancet. 650 is ejected from lancing device 102. [00303] i f wings 660a, 660b did not return to their extended position, then upon ejection it- is possible that sleeve 658 would not be locked into its extended position. To ensure that this docs not happen, the alternative embodiment of Figs.
• 82 through 84 includes a second pair of locking members or wings 680a > 680b formed in left and right lateral surfaces of lancet body 656 respectively, near the forward end of lancet body 656 and axial Ij' spaced from the first set of wings 660a, 660b.
• Wings 680a, 680b are similar in structure to wings 660a, 660b, but are of a material that is less flexible than the material of wings 660a, 660b, Each of wings 680a, 680b has a short, stiff base portion 682a, 682b (see Fig, 84) extending radially out from lancet body 656 and a planar flexion member 684a., 684b extending from the base portion 682a, 682b in generally forward direction but at an acute angle away from the major axis of the lance body 656. Second pair of wings 680a, 680b may be molded as part of lancet body 656.
• Planar flexion member 684a, 684b arc sized and configured so that the wing span of wings 680a, 680b is equal to or less than the diameter of the interior chamber 674 of sleeve 658, with the sleeve 658 having a diameter of less than 5 mm.
• second pair of wings 680a, 680b may be within the interior chamber 674 of sleeve 658, However, as shown in Pig.
• wings 680a, 680b since the wingspa ⁇ W of wings 680a, 680b is equal or less than the diameter of chamber 674, they remain in a relatively relaxed state (as compared to wings 660a, 660b) when placed into chamber 674 and are subject to little or no deformation. As a result, wings 68Oa 5 . 680b retain their resiliency even when lancet 650 remains in lancing device 102 for a long time.
• Wings 680a, 680b are configured so that, when the rear- facing surface of planar flexion members 684a, 684b engages neck 686, it is pushed toward the longitudinal axis of lanect body 656, in effect folding wings 680a, 68Ub to permit their passage through neck 686.
• wings 680a, 680b engage the rear end of sleeve 658, locking it in its extended position, [OQ3O7J Because tin,- flexion of wings 680a, 68Ub occurs for a short interval upon ejection of lancet 650, there is less chance that wings 6SOa, 680b will lose their resiliency and fail to extend to a wingspan sufficient to lock sleeve 658 into place. In the unlikely event that wings 660a, 660b were to Iaik wings 680a, 6SOb would in all piobabihty be operable to pi event sleeve 658 from sliding completely out of its extended forward position protecting needle sharp 654.
• ⁇ variety of structures may be used to perform the locking function. These other structures include, but are not limited to, pivoting members * that pivot rather than fold into the wing wells, studs that extend out from the lancet body that can be pushed into a retracted position into a well in the lancet body, oi barbs. For example, refeu ⁇ ng to bigs. 85-87.
• an alternative embodiment in ihc form of a lancet 6% is shown having a pair of bai bs 692a, 692h which, although having a diiferenf structure and orientation, perform the locking Junction as wtngs 6SUa, 6BOb.
• Lancet 600 is similar in tbn ⁇ and function let lancet 104 Lancet 690 includes a needle 6*-M (not shown) thai is encased i ⁇ elongated lautet body 6 ⁇ 8, ⁇ sleeve 700 slides axia ⁇ y over a portion oi the lancet body 69S between an extended position in which it protectively surrounds the needle sharp, and a rearward position in which a poiuon of sharp protiudes heyotid the front end of sleeve 700
• Lancet body 698 has a substantial cruciform cross section to define four elongated guide ribs /02a-d extending radially at ninety degs ee intervals.
• Jj Sleeve 700 includes a re.ui end having a unciform opening 704 to engage the four guide- ⁇ bs of lancet body 702a ⁇ d so that sleeve 700 e ⁇ m slide axially over laueei body 698, [00313] Extending from ribs 702a and ?02b are wings 706a and 706b, respectively.
• Wings 706a, 706b function substantially as wings 66Oa 1 660b described above. Wings 706a, 706b are configured as an inclined planar ilexion member extending from and integral with each of ribs 70.2a and 702b, respectively.
• Barbs 692a, 692b are aligned with ribs 702c and 702d 5 respectively. Barbs 692a,
• 692b have flexible portions 708a and 70Sb forming in a V-shaped configuration, with the point of the V facing rearward.
• the rearward ends of portions 708a, 708b define a width that is wider than the portions 71 Oa and 71 Ob of cruciform opening 704 that, receives barbs 692a, 692b when sleeve 700 moves rearward relative to lancet body 698.
• the inter chamber of sleeve 700 is sized to accommodate barbs 692a, 692b without deformation.
• sleeve 700 can be positioned relative to lancet body 698 so that barbs 692a, 692b arc within the interior chamber of sleeve 700, which includes opposing longitudinal engagement surfaces 712a and 712b (see Figs. 86 and 87) sized and positioned to accommodated barbs 692a, 692b, thus permitting sleeve 700 to slide axially relative to lancet body 698.
• sleeve 700 When lancet 690 is ejected from lancing device 102, for example, sleeve 700 is pushed forward until barbs 692a, 692b are forced through portions 710a and 710b of cruciform opening 704 in the rear of sleeve 700.
• the opening portions 710a, 710b are more narrow than barbs 692a, 692b, barbs 692a, 692b arc configured so that when the rear- lacing surface of each flexible portion 708a, 708b engages opening portions 710a, 710b, barbs 692a, 692b arc squeezed to in effect pinch the barbs 692a, 692b and permit their passage through the opening portions 710a, 710b.
• Ejection locking member 750 operates in conjunction with an ejection actuator 516" similar in construction and function to ejection actuator 516 described above.
• V-shaped blocking portion 752 formed b> two elongated members 754 and 756 at approximately right angles to each other, each lying in a common horizontal plane.
• Friending vertically from the distal cad of member 75-1 is au elongated guide arm 758.
• Rxkmding venicall)- from the distal end of member 756 is an elongated anchor arm 760.
• Anchor ti ⁇ n 760 terminates in a Z -Shaped anchor portion 762.
• Ejection locking arm is mounted t ⁇ a carriage 580.
• Fjecho ⁇ locking member 750 is installed on carriage 580 so that anchor portion 702 is secured by a receiving notch 764 on carnage 580 (seen in Fig. 9] and 92) and guide aim 758 is slid ⁇ bly engaged by a vertical notch 766 in carriage 580, In this configuration, blocking portion 752 is interposed in the path of la ucet earlier 208 ⁇ so that the forward movement of laneet carrier 208 * along its longitudinal axis is blocked, as shown in Figs. 89 and 92. Note that for clarity carriage 580 is not illustrated in Fig. 89.
• ⁇ n advantage of ejection locking member /50 is that its neutral position is blocking lancet earner 208'. Thus when ejection actuator 516 ' is moved forward, the spung-like S l action of ejection locking .member 750 provides for reliable and quick transition to a blocking position.

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