WO2006038044A2 - Microlance dermatologique - Google Patents

Microlance dermatologique Download PDF

Info

Publication number
WO2006038044A2
WO2006038044A2 PCT/GB2005/050176 GB2005050176W WO2006038044A2 WO 2006038044 A2 WO2006038044 A2 WO 2006038044A2 GB 2005050176 W GB2005050176 W GB 2005050176W WO 2006038044 A2 WO2006038044 A2 WO 2006038044A2
Authority
WO
WIPO (PCT)
Prior art keywords
lancet
wheel
firing
carousel
carriage
Prior art date
Application number
PCT/GB2005/050176
Other languages
English (en)
Other versions
WO2006038044A3 (fr
Inventor
Tony Cummings
Original Assignee
Owen Mumford Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GB0422325A external-priority patent/GB0422325D0/en
Priority claimed from GB0424539A external-priority patent/GB0424539D0/en
Application filed by Owen Mumford Ltd filed Critical Owen Mumford Ltd
Publication of WO2006038044A2 publication Critical patent/WO2006038044A2/fr
Publication of WO2006038044A3 publication Critical patent/WO2006038044A3/fr

Links

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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15176—Stocking means comprising cap, cover, sheath or protection for aseptic stocking
    • 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
    • A61B5/150175—Adjustment of penetration depth
    • A61B5/15019—Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism
    • 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
    • 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
    • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • 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
    • A61B5/15111—Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15149—Arrangement of piercing elements relative to each other
    • A61B5/15151—Each piercing element being stocked in a separate isolated compartment
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15159—Piercing elements stocked in or on a disc
    • A61B5/15161—Characterized by propelling the piercing element in a radial direction relative to the disc
    • 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
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/1518—Security or safety mechanism to be deactivated for forwarding next piercing element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/008—Racks for supporting syringes or needles

Definitions

  • the present invention relates to skin lancing apparatus and in particular to such apparatus comprising multiple lancets.
  • Known lancing systems comprise a spring-activated pen-like device to which disposable lancets are attached.
  • the lancets consist of a needle embedded at one end within a plastics holder.
  • a user clips a new lancet onto the end of the pen device and removes a protective plastic cover.
  • the firing mechanism within the pen is then cocked, and the end of the pen placed in contact with the subject's skin and fired, causing the needle to pierce the subject's skin.
  • the lancet is removed from the pen device and disposed of.
  • Lancets are typically provided in packs of 50 or so, packed loosely or stacked in some suitable container.
  • a known alternative lancing system comprises a separate driving pen and a cartridge of lancets.
  • the cartridge contains lancets stacked side by side or arranged on a carousel mechanism and which may be extracted one at a time using the driving pen. The user must manually introduce the pen to extract a lancet from the cartridge.
  • Lancet reuse is relatively easy, whether by design or by accident, creating a risk of contamination and infection. A user may sometimes forget that the pen contains an old lancet instead of a fresh one.
  • US6,616,616 describes a lancet system comprising a plurality of lancets and a transport unit for moving the lancets in turn to a withdrawal or lancing location.
  • a drive unit is provided for driving a lancet in the withdrawal position so as to prick the skin of a subject.
  • US Patent No. 4,794,926 discloses a lancing system for drawing blood samples from a subject which includes upper and lower housings for containing a "wheel" of lancets, each spoke of the wheel having a downward-pointing needle tip for breaking the skin of the patient. Each spoke is fixed only at the centre of the wheel and can flex up and down at its free end. The wheel is rotated such that the lancets are brought in turn to a lancing position where each lancet is raised up a ramp and, when a trigger is activated, the lancet comes off the ramp under its own spring motion, the needle tip protruding from the bottom surface of the lower housing to penetrate the subject's skin.
  • a disadvantage of this system is that the spring force applied to each lancet may not be sufficient to penetrate the subject's skin, resulting in the need to use another lancet in the wheel.
  • a lancet wheel comprising a plurality of radially extending needles suitable for piercing tissue when the wheel is moved in the plane of the wheel, and means for attaching the wheel to a lancing device so that the wheel is rotatable about its axis.
  • the needles may project from a single moulded plastics part.
  • the single moulded plastics part may comprise a plurality of fingers with the needles embedded in the respective ends thereof.
  • Each of the fingers may be flexible.
  • a compressible feature for encasing the radially extending needle may be disposed at the end of each finger.
  • There may be a finger which does not have a needle embedded therein.
  • the fingers may be spaced at equiangular separations.
  • the ends of the fingers may be tapered.
  • a central portion of the lancet wheel may comprise a clutch surface for aligning lancets in conjunction with a lancing device and for preventing unnecessary rotation of the lancet wheel with respect to the lancing device.
  • the clutch surface may comprise a substantially continuous ring of radially extending grooves coaxial with the axis of the wheel, the angular separation of the grooves corresponding to the angular separation of the fingers in the lancet wheel.
  • the lancet wheel may comprise drive engagement means comprising a substantially continuous ring of axially extending grooves coaxial with the axis of the wheel, the angular separation of the grooves corresponding to the angular separation of the fingers in the lancet wheel.
  • the ring of grooves on the drive engagement means may comprise a portion where no groove is provided.
  • the lancet wheel may have upper and lower surfaces, wherein the clutch surface and drive engagement means are disposed upon the lower surface of the lancet wheel.
  • the lancet wheel may further comprise a releasable attachment mechanism for attaching the lancet wheel to a lancet firing device.
  • the lancet wheel may have upper and lower surfaces and a passage through its centre for receiving a spindle of a lancet firing device, wherein the releasable attachment mechanism comprises a support adjacent the passage projecting upwards from the upper surface of the wheel, the upper end of the support being capable of flexing toward and away from the wheel axis, and the releasable attachment mechanism further comprising an arm extending from the upper end of the flexible support so as to intersect with the axis of the wheel, the arm having a slot formed therein for receiving a wheel-mounting spindle of a lancet firing device.
  • the lancet wheel may further comprise a wheel cover arrangement arranged in a non- use position to cover the ends of the lancets in the lancet wheel, and in a use position to be partially raised to expose the ends of the lancets in the lancet wheel.
  • the wheel cover arrangement may comprise an outer ring and an inner ring connected to the outer ring by a plurality of radially extending flexible members, the cover arrangement being attached to the wheel at the inner ring, and the outer ring extending downwards to cover the ends of the lancets in the non-use position.
  • the outer ring may further comprise a plurality of lateral tabs arranged such that, in use, an application of upward force to the lateral tabs causes the flexible members to bend upwards at their outer extent, thereby raising the outer ring away from the lancets of the lancet wheel.
  • a device for firing lancets suitable for piercing tissue comprising a housing and a mounting means disposed within the housing for mounting a lancet wheel, the device further comprising driving means for driving the lancet wheel in a direction parallel to the plane of the wheel.
  • the mounting means may comprise a carriage which is slidably fixed within the housing.
  • the housing may comprise a track within which the carriage is slidably fixed.
  • the carriage may comprise a wheel-mounting spindle projecting from the carriage for receiving a lancet wheel, the spindle having an annular wheel-locking groove formed therein.
  • the device may further comprise a rib arranged in use to cooperate with a drive engagement means of a lancet wheel to rotate the lancet wheel into a subsequent lancet position during motion of the carriage within the device.
  • the rib may be disposed upon the housing and extend in a direction parallel to the direction of motion of the carriage.
  • the carriage may comprise a clutch surface complimentary to a clutch surface provided on a lower surface of a lancet wheel for aligning lancets and for preventing unnecessary rotation of the lancet wheel with respect to the lancing device.
  • the clutch surface may comprise a substantially continuous ring of radially extending grooves coaxial with the axis of a lancet wheel, the angular separation of the grooves corresponding to the angular separation of the lancets in the lancet wheel.
  • the driving means may comprise a firing spring for imparting a firing force to the carriage, disposed between the carriage and a reaction plate.
  • the device may comprise at least one firing button, wherein the firing spring, when compressed, is releasable by the firing button.
  • the driving means may further comprise a cocking mechanism for loading the firing spring.
  • the device may comprise a cocking button, wherein the cocking mechanism comprises a cocking spring disposed between the reaction plate and the cocking button.
  • the device may further comprise means for releaseably connecting the cocking button to the carriage upon depression of the cocking button, the carriage further comprising a rearward-projecting flexible leg member with a laterally-projecting snap member formed thereupon arranged such that when the carriage is in a retracted position, the snap member is disposed adjacent the firing button, the flexible leg member is ramped against an inclined surface at a rear end of the device, and the cocking button is released from the carriage.
  • the device may further comprise stop means formed integrally with the housing and disposed such that the stop means opposes relative motion of the carriage and the housing when the carriage is in the retracted position through contact with the snap member.
  • the firing button may further comprise an inwardly-facing catch arranged such that depression of the firing button causes separation of the snap member and the stop means, allowing the firing spring to drive the lancet wheel into a firing position.
  • the device may further comprise ramp members disposed at a forward end of the device, arranged such that, in use, the two lancets of a lancet wheel adjacent the forwardmost lancet are biased away from the front of the device when the lancet wheel is in a firing position.
  • the housing may comprise an aperture through which the lancet wheel may be inserted into the device, the aperture having a lid for closing the aperture.
  • the device may further comprise depth adjustment means for varying the location of the firing position of the carriage.
  • depth adjustment means for varying the location of the firing position of the carriage.
  • a method of piercing skin comprising mounting a lancet wheel into a lancet firing device, the lancet wheel comprising a plurality of radially extending lancets, the tips of the lancets extending radially outwards in the plane of the wheel; driving the lancet wheel in a direction perpendicular to its axis; and rotating the lancet wheel to the next lancet position.
  • the trigger and the indexing means are arranged to move in the same or substantially parallel planes.
  • the carousel comprises a cog disposed coaxially with the axis of rotation of the carousel within the device.
  • the teeth of the cog have the same angular pitch as the lancets.
  • Said indexing means is arranged to engage an aligned tooth of the cog upon each activation of the firing mechanism.
  • the indexing means is pivotable about a pivot point, the device comprising means for deflecting the indexing means out of engagement with the carousel and return means for returning the indexing means back into engagement with the carousel.
  • the carousel comprises a cog for facilitating indexing
  • the arrangement is such that the indexing means engages a tooth of the cog in one direction of travel and is deflected substantially out of engagement in the reverse direction of travel.
  • a skin pricking apparatus comprising a lancet carousel holding a multiplicity of lancets arranged circumferentially around the centre of the carousel, the lancets being disposed with their needle tips pointing in an axial direction, and a firing device within which the lancet carousel is mounted for rotation about its axis, the firing device comprising: a casing; a hammer pivotally attached to the casing and biasing means for biasing the hammer into engagement with a lancet located in a firing position so as to drive the lancet to a lancing position; a lever pivotally attached to the casing and moveable about its pivot point to rotate the hammer against the biasing means to a cocked position, the lever and the hammer being rotatable in substantially the same plane or in substantially parallel planes; and release means for facilitating disengagement of the lever from the hammer in the cocked position.
  • Opposing surfaces of the hammer and the lever are preferably shaped such that the lever is in blocking engagement with the hammer over a part of its rotational travel, from a resting position to a position in which the hammer is cocked, and such that the members disengage upon further rotational travel of the lever in the same direction, thereby providing said release means.
  • the pivot point of the hammer is located radially inside the pivot point of the lever, with respect to the centre of the carousel.
  • the apparatus may further comprise indexing means pivotally attached to said lever for applying a substantially tangential force to the carousel upon rotation of the lever, so as to rotate the carousel to the next firing position.
  • the indexing means is moveable in substantially the same plane as the hammer and the lever or in a plane substantially parallel thereto.
  • a skin pricking apparatus comprising a lancet carousel holding a multiplicity of lancets arranged circumferentially around the centre of the carousel, the lancets being disposed with their needle tips pointing in an axial direction, and a firing device within which the lancet carousel is mounted for rotation about its axis so as to move lancets into and out of a firing position, the firing device comprising: a casing; a hammer pivotally attached to the casing and biasing means for biasing the hammer; cocking means for moving the hammer to a cocked position against the action of said biasing means; release means for releasing the hammer from the cocked position so as to allow the biasing means to drive the hammer into engagement with a lancet located in a firing position; and the hammer comprising latch means for latching the hammer to the engaged lancet, whereby the lancet
  • a skin pricking apparatus comprising: a lancet carousel holding a multiplicity of lancets arranged circumferentially around the centre of the carousel, the lancets being disposed with their needle tips pointing in an axial direction, each lancet comprising spring biasing means for biasing the needle tips towards a position in which they project from the carousel, and locking means associated with each lancet for releaseably locking a biasing means in its compressed state; a firing device within which the lancet carousel is mounted for rotation about its axis, the firing device comprising a finger actuable trigger for engaging the locking means of a lancet located in a firing position to release the biasing means of that lancet causing the needle tip to be driven to a lancet firing position; and indexing means for rotating the carousel to the next firing position following firing.
  • Figure 1 illustrates a lancet wheel and cover (detached) in accordance with an embodiment of the present invention
  • Figures 2a and 2b are plan views of the lancet wheel of Figure 1;
  • Figures 3a and 3b are cross-sections through the lancets of the lancet wheel of Figure 1;
  • Figure 4 illustrates the lancet wheel of Figure 1 with its cover attached and flexed upwards;
  • Figure 5 illustrates the underside of the lancet wheel of Figure 1
  • Figure 1 Figure 7 is a perspective view of the internal components of the device of Figure 6;
  • Figure 8 is a cross-section through the lancet device illustrated in Figure 7;
  • Figure 9 is a cross-section of the lancet wheel of Figure 1 mounted upon the device of
  • Figure 10 is a close-up cross-section of a firing mechanism of the device of Figure 6;
  • Figure 11 is a plan view cross-section of the lancet firing device of Figure 6 with its upper casing removed and the lancet wheel of Figure 1 attached;
  • Figure 12 is a side-view cross-section of the lancet wheel of Figure 1 and the firing device of Figure 6;
  • Figures 13 to 19 illustrate the firing mechanism of the device of Figure 6; and Figures 20 to 22 illustrate a depth adjustment mechanism of the device of Figure 6 in accordance with a further embodiment of the present invention.
  • Figure 23 shows a perspective view of a lancing device according to an embodiment of the present invention.
  • Figure 24 shows a perspective view of an internal firing mechanism of the device of Figure 23;
  • Figure 25 shows a perspective view of a multi-lancet carousel for insertion into the device of Figure 23;
  • Figure 26 shows the device of Figure 23 with the outer housing removed and the carousel of Figure 25 inserted;
  • Figure 27 is an axial cross-sectional perspective view of the arrangement of Figure 26 in a first operational configuration
  • Figure 28 is an axial cross-sectional perspective view of the arrangement of Figure 26 in a second operational configuration
  • Figure 29 is an axial cross-sectional perspective view of the arrangement of Figure 26 in a third operational configuration
  • Figure 30 is an axial cross-sectional perspective view of the arrangement of Figure 26 in a fourth operational configuration
  • Figure 31 shows a perspective view of an alternative internal firing mechanism of the device of Figure 23;
  • Figure 32 shows a perspective view, in partial cut-away and exploded views, of a multi- lancet carousel for use with a device comprising the firing mechanism of Figure 31;
  • Figure 33 shows a detail of the carousel of Figure 32;
  • Figure 34a shows a reverse side view of the firing mechanism of Figure 31, with the carousel in place;
  • Figure 34b is an axial cross-sectional perspective view of the firing mechanism of
  • Figure 31 with the carousel of Figure 33 inserted, in a first operational configuration
  • Figure 35 shows the arrangement of Figure 34 in a second operational configuration
  • Figure 36 shows the arrangement of Figure 34 in a third operational configuration
  • Figure 37 shows the arrangement of Figure 34 in a fourth operational configuration
  • Figure 38 shows a detail of the arrangement in the fourth configuration
  • Figures 39 to 41 show sequential details of the arrangement during a release phase;
  • Figure 42 shows a perspective view of a multi-use lancing device according to a further embodiment of the invention.
  • Figure 43 shows a perspective view of an internal firing mechanism of the device of
  • Figure 44 shows a perspective view of a multi-lancet carousel for use with the device of Figure 42, in both partial cut-away and exploded views;
  • Figures 45 to 47 illustrate the construction of a lancet mounting tube of the carousel of
  • Figure 48 illustrates in detail a lancet of the carousel of Figure 42
  • Figure 49 illustrates axial cross-section and exploded views of the multi-use lancing device with carousel;
  • Figure 50 shows the device of Figure 42 with the carousel inserted, in a first operational configuration
  • Figure 51 shows the arrangement of Figure 50 in a second operational configuration
  • Figure 52 shows a detail of the carousel in the second configuration with a needle protecting foam cover in a compressed state
  • Figure 53 shows the arrangement of Figure 50 in a third operational configuration
  • Figure 54 shows the arrangement of Figure 50 in a fourth operational configuration
  • Figure 55 illustrates a detail of an alternative lancet construction with a needle protecting cover in a compressed state
  • Figures 56 and 57 illustrate a user removable seal for sealing the lancet carousel of
  • Figure 58 shows a further user removable seal for the carousel of Figure 44; and Figure 59 illustrates a modification to the firing and indexing mechanism of Figure 43.
  • the embodiment described below comprises two main parts: a disposable lancet wheel which comprises a number of radially-projecting lancets, and a multi-use device into which the lancet wheel is placed.
  • the device has a mechanism for cocking and firing the lancet wheel, and for rotating the lancet wheel around to the next position after each use. After all of the lancets have been used, or at any time when only some of the lancets have been used, the lancet wheel may be safely removed from the device and the wheel disposed of.
  • the device provides a convenient and safe delivery mechanism for the lancets.
  • FIG. 1 illustrates the lancet wheel 1 and a wheel cover 2.
  • the lancet wheel 1 comprises a single moulded plastics part providing a central disc-shaped portion 3 through which a central mounting hole 3 a is provided.
  • a cylindrical collar 4 is disposed around the central hole 3a on the upper side of the lancet wheel.
  • the cylindrical collar 4 has two vertical slots 4a, 4b formed therein to isolate a support 5.
  • the support 5 can flex slightly towards and away from the central axis of the wheel.
  • At the upper end of the support 5 there is an inward-projecting arm 6 which projects into the area above the central hole 3a within the collar 4.
  • the arm 6 has a slot 7 formed within it.
  • the slot 7 is irregularly shaped such that the diameter of the aperture presented by the slot to the area above the central hole 3 a increases when the support 5 is pushed towards the axis of the wheel.
  • the shape of the slot is illustrated in Figure 2a, with diameter X above the axis of the wheel.
  • Figure 2b show the support 5 moved in slightly, with diameter Y (Y>X) above the axis of the wheel.
  • the arm 6 cooperates with a lancet firing device to form a clutch spring 15 which acts to bias the wheel downwards when in use.
  • a plurality of equally-spaced lancet fingers 8 project radially from the periphery of the central disc portion 3. There are a large number of lancet fingers, approximately forty.
  • a needle 13 is embedded in the end of each lancet finger 8 and projects therefrom. The needle 13 is the portion of the wheel used to penetrate the subject's skin.
  • One of the lancet fingers 9 acts as a blank and has no needle embedded therein. The blank lancet finger can be used as an indicator to show how many lancets have been used.
  • Each needle 13 is covered by a compressible feature 14. This feature may be made from, for example, foam, rubber or a thermoplastic elastomer (TPE) material.
  • the foam may be a closed cell foam in order to keep the needles sterile before use and encased after use to prevent contamination.
  • Figures 3a and 3b illustrate possible arrangements of the compressible feature 14.
  • the compressible feature takes the form of a "bellows" which comprises a solid tube of compressible material surrounding the needle. When this material is compressed to expose the needle, it expands radially outward from the needle axis.
  • Figure 3b shows a "thin sheaf type compressible feature which comprises a narrow tube section of compressible material which closely surrounds the length of the needle and a larger end portion at the needle tip. Upon compression of the thin sheaf feature, the narrow tube section crumples along its length and does not result in any significant lateral expansion of compressible material.
  • the lancet wheel cover 2 is formed from a single moulded plastics part and is circular in cross-section, being shaped so as to cover the upper surface and circumference of the lancet wheel 1, including the needles 13.
  • Figure 4 shows the wheel cover 2 in situ upon the lancet wheel 1 with the periphery of the cover flexed upwards (see below).
  • the cover comprises an outer ring 2a which covers the needles to prevent the user accidentally touching the needles, and an inner ring 2b which provides a central aperture 2e that corresponds to the cylindrical collar 4 of the lancet wheel.
  • the inner ring and outer ring are connected by flexible members 2c which can flex in an upward direction to expose the needle ends of the lancet fingers.
  • the cover is also provided with two tabs 2d upon the outer ring.
  • the wheel cover is omitted for clarity. The elements which cause the cover to flex upwards are also omitted.
  • a first clutch member 10 is provided beneath the cylindrical collar 4 and comprises a ring of v-shaped grooves, the grooves extending radially outwards from the centre of the lancet wheel 1.
  • an indexer 11 which comprises a further ring of v-shaped grooves, differing from the first clutch member 10 in that the direction of the grooves is axial.
  • the indexer 11 is provided with an indexer stop 12 which comprises a portion of the indexer 11 having no groove.
  • the position of the indexer stop 12 is located at a fixed angular displacement from the lancet blank 9 which has no needle embedded therein.
  • the angular separation of the grooves on the first clutch member 10 and on the indexer 11 corresponds to the angular separation of the lancet fingers 8 on the lancet wheel 1.
  • the lancet firing device 16 is illustrated in Figure 6 and comprises a teardrop-shaped body formed from upper and lower housings 17a and 17b.
  • the front end of the firing device has a small indent 16a for receiving a fingertip for lancing.
  • a substantially circular aperture 16b is formed towards the front end of the upper housing and is closable using a transparent lid 16c pivoted at its rear end to a point on the upper housing 17a.
  • the circular aperture is shaped so as to receive a lancet wheel.
  • the internal components of the lancet firing device 16 will now be described with reference to Figure 7, which illustrates the device with an upper housing section, including the lid, removed.
  • the device 16 comprises the lower teardrop-shaped housing 17b and a peripheral side wall 18 formed from a single moulded piece of plastics.
  • Disposed towards the larger, forward, end of the teardrop-shaped lower housing 17b is a carriage 19 for supporting and moving the lancet wheel, the carriage being aligned with the longitudinal axis of the housing.
  • the carriage is mounted on a pair of rails 40 moulded integrally with the lower housing 17b.
  • the rails and the mounting of the carriage thereon is best illustrated in Figure 8 which shows a cross-sectional view of the device which is transverse with respect to the direction of the rails. Lower features of the carriage snap into the rails to prevent removal of the carriage.
  • the carriage comprises a cylindrical, wheel-mounting spindle 20, fixed to and projecting from the upper surface of the carriage 19.
  • the wheel-mounting spindle 20 is shaped so as to be received by the central hole of a lancet wheel 1 as will be described below.
  • An annular groove 20a is formed in the upper end of the wheel-mounting spindle 20 for receiving the slot 7 of the arm 6 of the lancet wheel 1, as illustrated in Figure 9.
  • a second clutch member 21 Disposed around the base of the wheel-mounting spindle 20, on the upper surface of the carriage, is a second clutch member 21 which comprises a ring of v-shaped grooves, the grooves projecting radially outwards from the wheel-mounting spindle 20.
  • the number and shape of the grooves in the second clutch member are such that they are complimentary to those on the first clutch member 10 of the lancet wheel 1, the two clutch members together forming a clutch mechanism.
  • a needle exit point 22 is provided at the forward end of the housing within the side wall, in line with a firing end of the carriage 19, and within the finger indent 16a.
  • the inner surface of the exit point 22 is provided with two opposing ramps 23 which provide sloping surfaces forming a v-shape pointing towards the inner portion of the housing. There is a gap between the two ramps 23 at the apex of the v-shape to allow the end of a single lancet finger through the gap to the exit point 22.
  • a cutaway 17c is formed at a rear end of the housing to provide access for a cocking button 24 which is mounted within the rear end of the housing.
  • the cocking button 24 is arranged to move slidably in line with the longitudinal axis of the housing.
  • the cocking button is hollow and open at its inward-facing end.
  • the leading edge of the cocking button 24 comprises two small catches 24a, 24b which extend sideways, slightly wider than the cocking button itself.
  • a cocking button spring 25 is mounted within the cocking button 24 at one end, projecting into the device.
  • the cocking button spring 25 is a relatively strong spring.
  • the other end of the cocking button spring 25 is attached to one side of a fixed plate 26 which is formed upon the device housing.
  • a firing spring 27 is attached at one end to the other side of the fixed plate 26 and is a weaker spring than the cocking button spring 25. The axes of both springs are aligned with the longitudinal axis of the lancet firing device. The other end of the firing spring 27 is attached to a plate 28 which is an integral part of the carriage 19 and is moveable therewith.
  • Two firing buttons 29 are provided towards the same end of the device as the cocking button, disposed one to each side of the device.
  • the firing buttons 29 are overmoulded with TPE material 30 which protrudes onto the inner surface of the buttons. The inner portion of the TPE material 30 is used to apply a light force to the firing buttons to keep them in place.
  • the TPE As the firing buttons are pressed, the TPE is compressed against and acts as a return spring after release to force the firing buttons back out to their normal position.
  • the arrangement of the firing button overmould is illustrated in Figure 10.
  • the firing buttons are provided with small firing button catches 29a on their internal surfaces.
  • An indexer rib 37 which may be formed as part of the lower housing 17b is disposed on the upper surface of the lower housing 17b adjacent the moveable plate 28.
  • the indexer rib 37 is fixed in place and comprises a tapered piece of plastic running parallel to the longitudinal axis of the device.
  • the first, inner, pair of legs 32 run either side of and parallel to the cocking button 24.
  • the latches 33 provide sloped surfaces that run parallel to the corresponding respective sloping surfaces of the ramps 31.
  • the second, outer, pair of legs 34 also run parallel to the cocking button but are disposed at a wider separation. Each of the outer legs 34 is flexible about its point of attachment to the carriage 19.
  • Each of the outer legs 34 has a snap member 35 which has a sloping outwardly facing surface with a lip formed therein.
  • a pair of stops 36 are formed integrally with the housing and are shaped to allow the sloping surfaces of the snap members 35 to ride over them as the carriage is pulled to a cocking position (see below) until the lips are snapped inwardly to lock the carriage in a cocked position.
  • the lancet firing device 16 is initially empty, i.e. a lancet wheel 1 has not been loaded within the device.
  • the lancet wheel 1 is loaded into the lancet firing device when the carriage is in a "resting position".
  • the wheel must be correctly aligned with respect to the device, and this may be achieved by aligning a mark on the wheel (e.g. one of the lancet fingers is coloured or distinctively shaped) to a feature on the device.
  • features on the protective case and the casing may provide for alignment for the wheel. This ensures that all of the lancets are used before the device prevents further firing.
  • the cylindrical collar 4 of the lancet wheel is aligned with the wheel-mounting spindle 20 and the lancet wheel lowered thereupon.
  • the diameter X of the slot 5d corresponds to the external diameter of the annular groove 20a and is less than the diameter of the upper end of the spindle.
  • the user therefore has to squeeze the support 5 towards the axis of the wheel, thereby presenting diameter Y of the slot to the upper end of the spindle. Since diameter Y is larger than that of the upper end of the spindle, the wheel can then be lowered. The user then releases the support 5 which flexes back out, and the slot 5d then rests securely around the annular groove 20a in the spindle with the wheel and carriage locked securely together.
  • the first clutch member 10 mates with the second clutch member 21.
  • the two clutch members lock together to form a clutch mechanism which prevents the wheel from rotating freely within the device.
  • the clutch mechanism also aligns the lancet fingers with the needle exit point.
  • the two tabs 2d on the wheel cover are pushed upwards by engagement with complimentary features provided on the carriage (see Figure 4), thereby flexing the outer ring 2a of the wheel cover 2 upwards and exposing the lancet needles 13 as described above.
  • the lid of the device is then closed and it is ready for use.
  • the lancing process consists of two separate actions. Firstly the device is "cocked", which involves rotating the carriage round so that the next needle to be used is aligned with the needle exit point, and loading the firing spring. Secondly, the device is fired such that the carriage is driven forwards and the needle is exposed at the needle exit point, the carriage then retracting and pulling the exposed needle back into the device housing.
  • the cocking process involves the user pressing in the cocking button 24, which compresses the cocking button spring 25 against the fixed plate 26.
  • the cocking button catches 24a, 24b ride up along the latches 33 on the inner legs, forcing them out slightly.
  • the inner legs move back into their original position. This configuration is shown in Figure 15.
  • the cocking button spring expands under its own restoring force against the fixed plate 26, returning the cocking button to its outer position as shown in Figure 16.
  • the carriage Since the cocking button catches are biased against the catches 33 on the inner legs, the carriage is drawn backwards with the cocking button. As the carriage is drawn backwards, the sloped surfaces of the snap members 35 slide against and past the sloped surfaces of the stop means 36.
  • the outer legs are flexible about their point of attachment to the carriage, and bend in, away from their usual position as they are biased against the stop means, moving back out to their original position once they have passed the stop means.
  • the grooved indexer 11 on the lancet wheel comes into contact with the tapered edge of the indexer rib 37 formed in the housing. This contact begins to push the lancet wheel 1 around to the next lancet position.
  • the first clutch member 10 of the wheel is rotated by this action towards the next groove position.
  • the rotation of the first clutch member against the second clutch member 21 of the carriage 19 causes the lancet wheel 1 to ride upwards relative to the carriage against the action of the clutch spring 15 which is effectively locked to the carriage, freeing the lancet wheel to rotate.
  • the force exerted by the arm pushes the lancet wheel downward after the apex of the groove has been overcome, closing the two clutch members together in the next position.
  • the next lancet finger is then aligned with the exit point.
  • the firing spring is then able to expand, its expansion forcing the plate 28 and therefore the carriage 19 forwards.
  • the forwardmost lancet finger 6 is in line with the needle exit point and as the finger approaches the needle cover, feature 14 comes into contact with the inner side of the casing at the needle exit point. Since the needle cover feature is compressible, the forward motion of the lancet finger causes the material to be compressed, thereby exposing the needle 13 as illustrated in Figures 3a and 3b.
  • the two lancet fingers adjacent the forwardmost lancet are flexed away from the forwardmost lancet by the two ramps 23, ensuring adequate clearance room for the lancet being fired.
  • the carriage 19 continues its forward motion under expansion of the firing spring 27 until further motion is prevented by the carriage coming into contact with a carriage stop 19a formed upon the base of the housing, at which point the needle protrudes from the device, lancing the subject as it does so. This position is shown in Figure 19.
  • the indexer stop 12 in the indexer stops the wheel rotating any further because there is no indexer groove for the indexer rib 37 to push round.
  • the blank indicator lancet will be in the forwardmost position so that any re-cocking and firing will not result in a lancet protruding from the device. The user will then appreciate that the wheel must be changed.
  • the blank indicator lancet finger 9 can be made shorter (or, for example, distinctively coloured) than the other lancet fingers in order to emphasise that it does not contain a needle.
  • the lid is opened.
  • the device may include a mechanism for locking the device when the lid is opened, to prevent accidental firing.
  • the user can then remove the wheel from the firing device by squeezing in the support 5 such that the wider portion of the slot 7 is aligned with the upper end of the wheel-mounting spindle 20 and lifting the wheel up off the spindle.
  • the outer ring 2a of the wheel cover falls back into place since the upward force on the tabs 2d has been removed, thereby covering the needles and permitting safe disposal of the used lancet wheel.
  • Figures 20 to 22 show a mechanism for adjusting the depth to which the lancet tips penetrate the skin. This is achieved by varying the position of the mechanical stop 19a on the device housing.
  • Figure 20 shows a depth adjustment button 38 on the underside of the device 16.
  • the depth adjustment button 38 causes an indexed stepped block 39 to be moved into one of a plurality of available positions, each position adjusting the furthest forward position that the carriage can reach.
  • Figures 21 and 22 show the two extrema of the depth adjustments provided by the depth adjustment button 38. In Figure 21, the forward position of the carriage is further away from the exit point 22 than in Figure 22.
  • the carriage hits the block 39 and, since the tip of the lancet is of a fixed length, more of the lancet tip will be exposed in the embodiment of Figure 21 than in the embodiment of Figure 22, thereby providing different levels of skin penetration by the needle tip.
  • the lancet wheel is removed and disposed of.
  • the embodiment described above comprises a resilient latch formed on the lancet wheel and which co- operates with the carriage spindle to allow axial movement of the wheel relative to the carriage (for the purpose of engaging and disengaging the clutch mechanism during rotation of the wheel).
  • a resilient or sprung member may be formed on the carriage, e.g. as a part of the spindle, to provide for axial movement of the wheel.
  • the spindle may be inserted through a hole in the centre of the wheel, with the spindle having a rotatable head which can be moved, following insertion of the spindle into the hole, to lock and unlock the wheel to and from the device.
  • a reuseable lancing device 1 ' which is formed generally of moulded plastics parts. These include an outer housing 2' of generally cylindrical shape having a base, and a lid 3' attached to the housing at one edge by a hinge to facilitate access to the inside of the housing by opening the lid. Formed in the lid 3' is a depressed region 4' having a centrally located hole 5' passing therethrough.
  • a button or trigger 6' projects through a slot 7' formed in the side of the housing 2', and forms part of a firing mechanism which is described further below.
  • a resting position of the button 6 is shown in solid lines and is indicated by reference “A”.
  • An intermediate position is shown in dashed lines and is indicated by reference “B”. This represents a cocked position of the device.
  • a fired position of the device is also shown in dashed lines and is indicated by reference "C”.
  • Figure 24 illustrates an internal firing mechanism 8' of the device of Figure 23.
  • This mechanism fits snugly within the outer housing 2', and indeed certain components of the firing mechanism may be formed integrally with the housing.
  • the mechanism comprises a rectangular reaction plate 9', which is fixed to the housing 2', the plate having a cylindrical spindle 10' projecting outwardly therefrom.
  • a generally L-shaped hammer 11' having a head 12' is mounted on the spindle 10' so that it can rotate thereabout.
  • the spindle 10' also supports a torsion spring 13', the projecting leaves of which are biased against a first stop 14' which projects from the plate 9' and a second stop 15' which projects from the hammer 11'. This arrangement is such that the spring 13' biases the head 12' of the hammer in a downward direction with respect to Figure 24.
  • the button 6' is generally L-shaped in vertical cross-section, with a fixing plate 16' extending upwardly from the end of the button.
  • the fixing plate 16' is mounted with respect to the reaction plate 9' on a spindle 17' so as to allow the button to rotate about the spindle.
  • the opening 18' in the fixing plate through which the spindle 17' extends is generally oval in cross-section.
  • a coil spring 19' extends between the fixing plate 16 and a projection from the reaction plate 9', tending to rotate the button 6' clockwise about the spindle 17' as viewed in Figure 24. In the resting position, the spindle 17' tends to rest against the lower end surface of the opening 18', again as viewed in Figure 24.
  • the upper end of the fixing plate 16' is shaped to provide a first flat cam surfaces 20' for engagement with an end of the hammer opposed to the head end.
  • An arcuate return surface 22' is contiguous with the cam surfaces 20'.
  • Figure 25 illustrates a lancet carousel 23' (with partial cut-away) suitable for use with the device of Figures 23 and 24.
  • the carousel 23' comprises a generally cylindrical casing 24' with a series of axially aligned lancet mounting tubes 25' disposed around its periphery, within the casing.
  • the tubes are equally spaced from one another.
  • the tubes 25' have a small circular opening to the exterior of the casing (these openings are not visible in Figure 25).
  • the tubes 25' have a larger cut-away opening 26' to the exterior of the casing 24'.
  • a lancet 27' is mounted within each of the tubes, and comprises an enlarged plastics head 28', cylindrical in shape.
  • a needle 29' is embedded in the head such that its sharpened tip points away from the head.
  • Each lancet 27' is oriented such that the base 30' of the enlarged head 28'is exposed through the upper cut-away openings 26' of the tubes, and the needle points toward, and is aligned axially with, the corresponding lower circular opening in its mounting tube.
  • Each lancet needle 29' is surrounded by a coil spring 31' which acts against the enlarged head 28' to bias the lancet upwards and prevent movement of the lancet within the tube prior to firing.
  • An alignment spindle 32' projects from the top of the carousel 23' (as viewed in Figure 25) and is designed to mate with a circular recess formed in the housing 2'.
  • An alignment "cog” 33' extends around the base of the spindle 32'.
  • a number of "pips” (not shown) is provided in a circular arrangement around the base of the casing 24'. These mate with respective dimples formed on the underside of the lid 3' of the housing. These serve to align the carousel relative to the housing, whilst still allowing the carousel to rotate within the housing.
  • a first stage in the operation of the device of Figure 23 is the cocking of the firing mechanism. This involves loading the torsion spring to bias the hammer to a raised position.
  • a user places the pad of his or her finger into the depression 4' formed in the lid 3', and depresses the button 6'.
  • Figure 26 illustrates the configuration of the firing mechanism, with the carousel 23' loaded, after the button 6' has been depressed to some extent causing compression of the spring 19'. The pressure exerted on the button 6' tends to maintain the spindle 17' in contact with the lower surface of the opening 18'.
  • the button 6' has been rotated sufficiently to bring the cam surface 20' of the fixing plate 16' into contact with the end surface of the hammer 11'.
  • Further depression of the button 6' to the intermediate position causes the hammer 11' to be rotated in a clockwise direction, against the action of the torsion spring 13', raising the head 12' of the hammer above the carousel 23'.
  • the cam surface 20' of the button slides over the end surface of the hammer 11'. This configuration is illustrated in Figure 27.
  • the hammer 11' exerts no significant force on the lancet 27'.
  • the compressed spring 31' now forces the lancet back into its tube, retracting the lancet needle 29'. This process happens very rapidly, whilst the user is continuing to depress the button 6', compressing the spring 19' still further. The user then releases the button 6' which is returned towards its resting position by re-extension of the return spring 19'.
  • the arcuate return surface 22' of the button 6' slips over the edge of the hammer during this action. As the hammer is prevented from rotating further by the lancet, as the surface 22' slips over the hammer, the opening 18' slides across the spindle 17'.
  • the device is returned to the resting configuration which is illustrated in Figure 30, with the opening 18' having been pulled back so that its "lower” surface is again in contact with the spindle 17'. In this position, the head 12' of the hammer is located within the carousel.
  • Figures 26 to 30 illustrate an indexing mechanism 34' (omitted from Figure 24) for causing the carousel to rotate a new lancet into the firing position prior to the release of the hammer.
  • the mechanism 34' comprises an indexing arm 35' which is pivotably mounted on a spindle (not shown in the Figures) provided on the fixing plate 16' of the firing button 6'. Movement of the arm 35' is restricted by upper and lower stops 36' provided on the reaction plate 9', although a small amount of axial movement (relative to the axis of rotation of the carousel) is allowed.
  • the button 6' is depressed (i.e. moves upwards in the orientation shown in Figure 26), the arm 35' is pushed radially inwards.
  • the leading surface 37' of the arm engages one of the teeth of the cog 33' provided on the carousel, causing the carousel to be rotated to the next firing position.
  • the arm 35' is withdrawn.
  • An inclined surface 38' formed behind the leading surface 37' causes the arm to slide up over the cog, allowing the arm to return to its resting position without causing rotation of the carousel.
  • Figure 31 illustrates a firing mechanism 100' for use with the device of Figure 23, according to a further embodiment of the present invention.
  • the mechanism 100' is similar in principle to that of Figure 24, with the button 101' and indexing arm (omitted from Figure 31 but illustrated in later figures) being substantially identical.
  • the hammer 102' operates on a similar principle to that of the mechanism of Figure 24, being raised and released by depression of a firing button 101', and being biased by a torsion spring 103'.
  • Pivotally attached to an end of the hammer 102' is a plate 104' from which depends a lancet grasping tool 105'.
  • This tool 105' comprises a cylindrical shaft 106' which is slidable mounted in a support collar 124' fixed to the reaction plate 125'.
  • a cup-shaped plunger 107' To the end of the shaft 106' is fixed a cup-shaped plunger 107'.
  • the plunger is hidden in the illustration of Figure 31 but can be seen in Figures 34 to 41 to be described below.
  • a pair of slots 108' extend through an upper surface of the plunger 107' adjacent to where the plunger is fixed to the shaft 106'.
  • a number of small pips 109' (e.g. three, only one of which is illustrated in the Figure) are formed in a ring around an inner surface of the plunger 107'.
  • a cup-shaped cover 110' has an integral collar 111' which surrounds the shaft 106', above the plunger 107', such that the shaft can slide freely through the collar.
  • a pair of shafts 112' depend from the inner surface of the cover 110', adjacent to the collar, and engage respective ones of the slots 108' formed in the plunger. As the plunger moves up and down with respect to the cover, the shafts slide up and down within the slots.
  • Figure 32 illustrates a lancet carousel 113' for use with a device comprising the firing mechanism 100' of Figure 31.
  • Figure 32 illustrates a partial cut-away view of the carousel, as well as an axially exploded view.
  • Figure 33 illustrates in partial cross- section a detail of the carousel 113'.
  • the carousel comprises a series of mounting tubes 114' equally spaced around its periphery.
  • the tubes 114' are open at the upper ends.
  • Each tube has formed integrally therein a pair of standoff clips 115a', 115b', which extend vertically upwards from a lower surface of the tube.
  • each clip Whilst fixed at their lowermost ends, the clips 115' are able to deflect outwardly at their upper ends with respect to the tube.
  • Each clip has a stop member 116' formed on an inner surface thereof, the stop member having an inclined upper deflecting surface 117'.
  • Located within each tube 114' is a lancet 118' having an enlarged, cylindrical head 119' and a needle 120' projecting therefrom. The sharpened tip of the needle 120' projects downwardly and is aligned with a slot 121' in the lower surface of mounting tube, extending between the bases of the standoff clips 115'.
  • the lower surface 122' of the enlarged head 119', at the entry side of the needle, is slightly sloping around its periphery, and a groove 123' extends circumferentially around the centre of the head.
  • a lancet sits with its head entirely above the stops formed in the standoff clips, but in contact therewith so as to prevent significant movement of the lancet prior to firing.
  • the device and the carousel are provided with registration means for aligning the slot formed in the base of the mounting tube which is currently in the firing position, with the hole passing through the depression in the lid.
  • This may be for example the arrangement of pips and dimples described above with reference to the embodiment of Figures 23 to 30.
  • FIG. 34b shows a reverse side view of the firing mechanism.
  • a reverse side cam plate 127' is fixed to the firing button 101', with a cam surface 128' of the cam plate engaging an end of the hammer 102'.
  • the cam plate 127' acts to raise the hammer to its resting position, and maintain it in this position prior to firing.
  • Figure 34a illustrates the resting position of the device.
  • the plunger 107' sits within the cover 110', with the lower rim 126' of the cover sitting on the surface of the carousel, aligned with one of the mounting tubes.
  • Figure 35 illustrates the configuration of the firing mechanism 100' as the user starts to depress the button 101' (bearing in mind that the mechanism in the Figures is shown upside down).
  • the lancet needle 120' exits from the aligned slot 121' in the mounting tube 114', puncturing the skin of the user.
  • the button 101' brings the second cam surface 130' on the firing plate of the button into engagement with the hammer as described above, causing the button to slide outward and allowing the first cam surface 129' to subsequently pass over the end of the hammer.
  • Figure 42 illustrates a device 200' according to yet another embodiment of the present invention.
  • the device comprises an outer casing 201' with a lid 202' hingeably attached thereto.
  • the lid can be opened to allow insertion of a lancet carousel into the device.
  • a firing button 203' extends through the casing and is depressed by a user to both fire a lancet and advance the carousel to the next location.
  • Figure 43 illustrates a firing mechanism 204' of the device.
  • a firing and indexing arm 205' is fixed to the button.
  • the arm comprises an indexing finger 206' which has an upper triangular section (or pawl) 207' for engagement with the indexing cog 208' of a lancet carousel.
  • the indexing finger is able to move to a small extent in an axial direction with respect to the axis of rotation of the carousel in order to engage and disengage the triangular section with and from the indexing cog of the carousel.
  • the operation of the indexing mechanism is similar to that described with reference to the first and second embodiments, with the carousel being rotated by the pressing of the button 203', just prior to firing.
  • a firing finger 209' projects from an end of the arm 205' distal from the button.
  • Figure 44 illustrates in partial cut-away and in axial exploded view a lancet carousel 210' for use with the device 200' of Figure 42.
  • the carousel 210' is generally cylindrical, having axially extending lancet mounting tubes 211' equally spaced around its periphery.
  • Figures 45 to 47 illustrates in detail the construction of each mounting tube 211'.
  • a basic hollow tube is moulded as a single piece and comprises a link arm 212' which is attached to the tube body by flexible joints.
  • the link arm 212' has an upper lancet locking catch 213', and a lower trigger surface 214'. In the resting state, the locking catch 213' projects into the interior of the tube.
  • depression of the trigger surface 214' causes the link arm 212' to pivot slightly, moving the catch 213' radially outward with respect to the tube.
  • the lower half of the lancet is over moulded with some flexible plastics material 215'. This still allows for movement of the link arm upon depression of the trigger surface.
  • the construction and operation of the mounting tube is similar in principle to the lancets marketed by Owen Mumford (Woodstock, England) under the brand name Unarranging®, although that product is not provided with the overmoulding 215'.
  • each lancet comprises an enlarged plastics head 217' with a needle 218' embedded therein and projecting from one end of the head. Projecting from the other end of the head is a locating member 219'.
  • a coil spring 220' surrounds the locating member 219' and is used to provide a driving force for the lancet.
  • a groove 221' extends circumferentially around the head of the lancet. This provides a means for engaging the locking catch 213' of the link arm 212' when the coil spring 220' is compressed, securing the lancet in a cocked position.
  • Each lancet needle 218' is encased in a cylinder of closed cell foam 222' which is compressible to some extent, as best illustrated in Figure 48. Prior to firing of a lancet, this foam cylinder maintains sterility of the needle. Following use and as will be described below, the cylinder also acts to encase the needle, preventing contamination or infection by a used needle. It is noted that the inside diameter of the tube 211' is slightly greater than the diameter of the foam cylinder 222' to allow for radial expansion of the cylinder during firing.
  • Figure 49 shows an axial cross-section through the device 200' with the lancet carousel 210' inserted.
  • This Figure illustrates a spring closure 223' mechanism comprising a coil spring which is compressed when the hinged lid is closed on the housing.
  • the mechanism 223' allows for a small axial movement of the carousel relative to the lid, sufficient to allow rotation of the carousel between consecutive pips which define the firing positions.
  • Figure 49 also illustrates an exploded view of the main device components.
  • the link arm is pivoted, releasing the locking coil spring 220' surrounding the locating member 219' to extend, driving the lancet 216' through the mounting tube 211' until the foam cylinder 222' surrounding the lancet needle 218' encounters the end of the tube ( Figure 41).
  • the foam cylinder is compressed in the axial direction, with the needle being driven through and out of the end of the cylinder.
  • the needle 218' then passes out of the opening in the end of the tube, and that in the lid of the device, lancing the subjects finger as is illustrated in the detail of Figure 52.
  • the spring 220' is slightly over extended, and begins to draw back, bringing the needle back within the tuning.
  • the foam cylinder 222' re-expands to cover the needle. This configuration is illustrated in Figure 53.
  • Figure 55 illustrates an alternative construction for the lancet needle cover.
  • an elastomeric sheath 224' may be used. When the end of the sheath is pressed against the upper surface of the lancet mounting tube, the needle is able to penetrate the sheath and pass out through the small opening in the end of the tube. Upon withdrawal of the lancet, the sheath expands to once again cover the needle.
  • the end through which the lancets will project during lancing may be covered with a foil or cellophane seal.
  • a foil or cellophane seal This is illustrated in Figures 56and 57, where the cover 225' is peeled off following loading of the carousel 210' into the device 200', and prior to first use.
  • the seal may remain in place during use, with the lancet needles penetrating the cover during lancing. This is illustrated in Figure 58.
  • a further anti-rotation pawl may be provided on the reverse side of the cog 208'.
  • This second pawl has a similar shape to the pawl 207', but with the opposite inclination, such that the vertical face of the pawl engages the cog to prevent reverse rotation.
  • the second pawl is spring mounted such that it can be deflected downwards by forward rotation of the carousel. This construction is illustrated in Figure 59, with the second pawl being identified by reference numeral 400'.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Geometry (AREA)
  • Dermatology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention concerne une roue à lancettes comprenant plusieurs lancettes s'étendant de manière radiale et un dispositif de tir conçu pour lancer ces lancettes. La roue à lancettes comprend un moyen conçu pour relier la roue au dispositif de tir de telle sorte que ladite roue pivote autour de son axe. Le dispositif est conçu pour fournir une force d'entraînement à la roue à lancettes dans un sens parallèle au plan de la roue.
PCT/GB2005/050176 2004-10-08 2005-10-06 Microlance dermatologique WO2006038044A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB0422325.1 2004-10-08
GB0422325A GB0422325D0 (en) 2004-10-08 2004-10-08 Skin lancing apparatus
GB0424539A GB0424539D0 (en) 2004-11-08 2004-11-08 Skin lancing revolver
GB0424539.5 2004-11-08

Publications (2)

Publication Number Publication Date
WO2006038044A2 true WO2006038044A2 (fr) 2006-04-13
WO2006038044A3 WO2006038044A3 (fr) 2006-10-12

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EP1880670A1 (fr) 2006-07-21 2008-01-23 Roche Diagnostics GmbH Multi-lancettes
EP1974668A1 (fr) 2007-03-29 2008-10-01 Roche Diagnostics GmbH Système de connexion
EP2030566A1 (fr) * 2007-08-31 2009-03-04 Roche Diagnostics GmbH Système d'analyse pour déterminer une analyse dans un fluide corporel, magazine pour système d'analyse, acquisition d'échantillon intégré et élément d'analyse, et procédé d'analyse d'un liquide corporel
US20100249652A1 (en) * 2009-03-31 2010-09-30 Abbott Diabetes Care Inc. Integrated Analyte Devices and Processes
WO2013104677A1 (fr) * 2012-01-10 2013-07-18 Sanofi-Aventis Deutschland Gmbh Appareil de prélèvement d'un échantillon de sang
WO2013104668A1 (fr) * 2012-01-10 2013-07-18 Sanofi-Aventis Deutschland Gmbh Cartouche
WO2013104675A1 (fr) * 2012-01-10 2013-07-18 Sanofi-Aventis Deutschland Gmbh Cartouche destinée à être introduite dans un dispositif de mesure, dispositif de mesure destiné à accueillir une cartouche et système comprenant un dispositif de mesure et une cartouche
US9066689B2 (en) 2008-05-03 2015-06-30 Roche Diagnostics Operations, Inc. Lancet wheel and method for producing a lancet wheel
CN109890280A (zh) * 2016-10-31 2019-06-14 德克斯康公司 经皮分析物传感器系统和方法
US10905360B2 (en) 2013-01-23 2021-02-02 Facet Technologies, Llc Push-to-charge lancing device
US11134896B2 (en) 2017-06-23 2021-10-05 Dexcom, Inc. Transcutaneous analyte sensors, applicators therefor, and associated methods
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US11627900B2 (en) 2003-12-05 2023-04-18 Dexcom, Inc. Analyte sensor
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US11627900B2 (en) 2003-12-05 2023-04-18 Dexcom, Inc. Analyte sensor
US8062235B2 (en) 2005-07-19 2011-11-22 Ihq Innovation Headquarters Oy Health monitoring device, device modules and method
WO2007010087A3 (fr) * 2005-07-19 2007-05-24 Ihq Innovation Headquarters Oy Dispositif de controle de l'etat de sante, modules du dispositif et procede
WO2007010087A2 (fr) * 2005-07-19 2007-01-25 Ihq Innovation Headquarters Oy Dispositif de controle de l'etat de sante, modules du dispositif et procede
EP1880670A1 (fr) 2006-07-21 2008-01-23 Roche Diagnostics GmbH Multi-lancettes
EP1974668A1 (fr) 2007-03-29 2008-10-01 Roche Diagnostics GmbH Système de connexion
EP1974667A1 (fr) * 2007-03-29 2008-10-01 Roche Diagnostics GmbH Système de connexion
WO2009027010A2 (fr) * 2007-08-31 2009-03-05 Roche Diagniostics Gmbh Système d'analyse pour déterminer la présence d'un analyte dans un liquide corporel, magasin pour système d'analyse, élément intégré d'acquisition et d'analyse d'échantillon, et méthode d'analyse d'un liquide corporel
WO2009027010A3 (fr) * 2007-08-31 2009-04-23 Roche Diagnostics Gmbh Système d'analyse pour déterminer la présence d'un analyte dans un liquide corporel, magasin pour système d'analyse, élément intégré d'acquisition et d'analyse d'échantillon, et méthode d'analyse d'un liquide corporel
EP2030566A1 (fr) * 2007-08-31 2009-03-04 Roche Diagnostics GmbH Système d'analyse pour déterminer une analyse dans un fluide corporel, magazine pour système d'analyse, acquisition d'échantillon intégré et élément d'analyse, et procédé d'analyse d'un liquide corporel
US8888715B2 (en) 2007-08-31 2014-11-18 Roche Diagnostics Operations, Inc. Analysis system and method for determining an analyte in a body fluid with a magazine comprising integrated sample acquisition and analyzing elements
US11160926B1 (en) 2007-10-09 2021-11-02 Dexcom, Inc. Pre-connected analyte sensors
US9066689B2 (en) 2008-05-03 2015-06-30 Roche Diagnostics Operations, Inc. Lancet wheel and method for producing a lancet wheel
US20100249652A1 (en) * 2009-03-31 2010-09-30 Abbott Diabetes Care Inc. Integrated Analyte Devices and Processes
WO2013104677A1 (fr) * 2012-01-10 2013-07-18 Sanofi-Aventis Deutschland Gmbh Appareil de prélèvement d'un échantillon de sang
WO2013104675A1 (fr) * 2012-01-10 2013-07-18 Sanofi-Aventis Deutschland Gmbh Cartouche destinée à être introduite dans un dispositif de mesure, dispositif de mesure destiné à accueillir une cartouche et système comprenant un dispositif de mesure et une cartouche
US9351679B2 (en) 2012-01-10 2016-05-31 Sanofi-Aventis Deutschland Gmbh Cartridge and meter for receiving the cartridge
CN104159513A (zh) * 2012-01-10 2014-11-19 赛诺菲-安万特德国有限公司 筒
WO2013104668A1 (fr) * 2012-01-10 2013-07-18 Sanofi-Aventis Deutschland Gmbh Cartouche
US10905360B2 (en) 2013-01-23 2021-02-02 Facet Technologies, Llc Push-to-charge lancing device
US11166657B2 (en) 2015-12-30 2021-11-09 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
US11375932B2 (en) 2015-12-30 2022-07-05 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
US11642055B2 (en) 2015-12-30 2023-05-09 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
US11602291B2 (en) 2015-12-30 2023-03-14 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
US11331021B2 (en) 2015-12-30 2022-05-17 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
US11412966B2 (en) 2015-12-30 2022-08-16 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
US11992312B2 (en) 2016-10-31 2024-05-28 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
CN109890280A (zh) * 2016-10-31 2019-06-14 德克斯康公司 经皮分析物传感器系统和方法
US11510625B2 (en) 2017-06-23 2022-11-29 Dexcom, Inc. Transcutaneous analyte sensors, applicators therefor, and associated methods
US11395631B2 (en) 2017-06-23 2022-07-26 Dexcom, Inc. Transcutaneous analyte sensors, applicators therefor, and associated methods
US11504063B2 (en) 2017-06-23 2022-11-22 Dexcom, Inc. Transcutaneous analyte sensors, applicators therefor, and associated methods
US11311240B2 (en) 2017-06-23 2022-04-26 Dexcom, Inc. Transcutaneous analyte sensors, applicators therefor, and associated methods
US11311241B2 (en) 2017-06-23 2022-04-26 Dexcom, Inc. Transcutaneous analyte sensors, applicators therefor, and associated methods
US11207026B2 (en) 2017-06-23 2021-12-28 Dexcom, Inc. Transcutaneous analyte sensors, applicators therefor, and associated methods
US11134896B2 (en) 2017-06-23 2021-10-05 Dexcom, Inc. Transcutaneous analyte sensors, applicators therefor, and associated methods
US11382540B2 (en) 2017-10-24 2022-07-12 Dexcom, Inc. Pre-connected analyte sensors
US11350862B2 (en) 2017-10-24 2022-06-07 Dexcom, Inc. Pre-connected analyte sensors
US11331022B2 (en) 2017-10-24 2022-05-17 Dexcom, Inc. Pre-connected analyte sensors
US11706876B2 (en) 2017-10-24 2023-07-18 Dexcom, Inc. Pre-connected analyte sensors
US11943876B2 (en) 2017-10-24 2024-03-26 Dexcom, Inc. Pre-connected analyte sensors
USD1036676S1 (en) 2018-06-22 2024-07-23 Dexcom, Inc. Wearable medical monitoring device

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