USO05741288A
`
`United States Patent
`
`[191
`
`Rife
`
`[11] Patent Number:
`
`5,741,288
`
`[45] Date of Patent:
`
`Apr._ 21, 1998
`
`[54] RE-ARMABLE SINGLE-USER SAFETY
`FINGER STICK DEVICE HAVING RESET
`FOR MULTIPLE USE BY A SINGLE PATIENT
`
`Inventor: Douglas Earl Rife. Palo Alto, Calif.
`
`5,421 ,357
`5,423,847
`5,439,473
`5,454,828
`5,540,709
`5,628,764
`
`6/1995
`6/1995
`8/1995
`10/1995
`7/ 1996
`5/1997
`
`Ens1.1'i:5n:1 .................................. 138/754
`Strong et al.
`
`Assignee: Chemtrak, Inc., Sunnyvale, Calif.
`
`OTHER PUBLICATIONS
`
`Appl. No.: 670,513
`Filed:
`
`Jun. 27, 1996
`
`Int. Cl.‘ ..................................................... A61B 17/32
`U.S. Cl. ............................................. 606/181; 606/181
`Field of Search ............................ 606/167. 181-182,
`606/184-185, 189; 604/46-47, 136-137;
`128/760, 763. 770
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,449,529
`4,539,988
`4,658,821
`4,715,374
`4,889,117
`4,892,097
`4,976,724
`4,994,068
`5,207,699
`5,304,192
`5,314,441
`5,318,584
`5,324,303
`5,334,195
`5,366,469
`5,395,388
`
`5/1984
`9/1985
`4/1987
`12/1987
`12/1989
`1/1990
`12/1990
`2/1991
`5/1993
`4/1994
`5/1994
`6/1994
`6/1994
`8/1994
`11/1994
`3/1995
`
`Bums et al.
`Shirley et al.
`Chiodo et al.
`Maggie ...... ..
`Stevens ............
`Ranaletta et al.
`.
`Nieto et a1.
`
`............................ 128/314
`138/314
`128/314
`128/314
`606/181
`606/182
`606/182
`606/181
`606/182
`.. 606/181
`606/192
`606/182
`606/181
`.. 606/131
`
`Incision Technologies brochure, "I‘enderlettTM the tender
`touch for fingers” Rev. 7-91 (2 pages).
`
`Primary Examim:r—Michae1 Buiz
`Assistant Examiner—Nancy Mulcare
`Attorney, Agent, or Firm—Hana Verny
`
`[57]
`
`ABSTRACT
`
`A lancet or finger-stick device operable to make a small
`incision into the vascular tissue of the skin to induce a
`controllable blood flow is particularly suited for incisions of
`the finger-tip of a patient. The device and method provide
`multiple use by a single-user in that the device provides an
`autologous re—use feature, such that an individual can reset
`and reuse the device on the same patient in case of an
`accidental misfire prior to actual use or if the first incision
`does not provide a sufficient blood sample. A disabling
`mechanism which the individual performs immediately
`prior to disposal of the used device is incorporated into the
`invention. These features permit the user of a consumer
`self-test or professiona1—use test to re—stick an individual’s
`fingertip in the event that the first try is unsuccessful or the
`blood flow is inadequate. It also insures sterility of the
`unused unit and provides enhanced safety since the device
`cannot be accidentally fired or reused by another individual
`after being disposed.
`
`18 Claims, 11 Drawing Sheets
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`ACTA EX. 1021-001
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`ACTA Ex. 1021-001
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`

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`U.S. Patent
`
`Apr. 21, 1998
`
`Sheet 1 of 11
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`5,741,288
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`

`
`5,741,288
`
`1
`RE-ARMABLE SINGLE-USER SAFETY
`FINGER STICK DEVICE HAVING RESET
`FOR MULTIPLE USE BY A SINGLE PATIENT
`
`FIELD OF THE INVENTION
`
`This invention pertains to disposable single-user finger-
`stick or lancet devices used to initiate bleeding in a patient,
`and more particularly to disposable single-user lancet
`devices that involve spring-loaded plunger type lancet tips
`and that include protective safety features to prevent reuse of
`a contaminated device by second users but provide a reset
`feature to permit resetting of a triggered device by a single
`user.
`
`BACKGROUND
`
`Lancets or other skin incision devices to enable relatively
`pain free blood sampling from the finger were traditionally
`designed for multiple use by health professionals, and later
`for use by diabetics who had a need to make frequent self
`tests of blood sugar levels. These early devices typically
`involved a pressure-released spring-loaded device into
`which a disposable metal lancet lip incased in a plastic
`housing was placed for each use. The Boehringer-Mannheim
`Autoclix® is an example of a reusable device of this type.
`Although the lancet points were relatively inexpensive, the
`units itself were not. and had to be cleaned between uses.
`
`More recently, it has come to light that cleaning of these
`reusable devices is often inadequate. and that bacteria or
`viruses can still be transmitted. The problem is particularly
`acute in light of the life-threatening nature of infectious
`agents, including the AIDS virus. This realization has lead to
`the development of numerous single-unit, disposable
`devices intended to maintain sterility. These single-unit
`devices may feature spring-loaded or push-button action.
`and either reusability or non-reusability. Some devices pro-
`vide puncture type incisions while others provide a slicing
`type skin incision. Commercial disposable devices of this
`type are available from Becton-‘Dickinson (Microtainer®),
`Hemochron TenderfootTM. Owen Mumford (Unistik® and
`Unistik®2), International Technidyne (Tenderlettm), Palco
`(EZ-let). and others.
`For example, the Owen Mumford (Unistik®) is a single-
`use non-rearmable spring-loaded device wherein a pull-tab
`covers the lancet tip and serves to assist the user in arming
`the lancet. The lancet is armed when the user removes the
`pull-tab cover, and the pull-tab is necessarily removed to
`expose the lancet tip before use. If the device is triggered by
`pressing a release button on its exterior (easfly done acci-
`dentally while holding the small device) then the lancet tip
`is propelled forward to pierce the skin when held against the
`skin, and cannot subsequently be re-armed if the triggering
`was accidental or for some reason. ineffective in incising the
`skin. Neither can the Unistik®2 be rearmed and reused by
`the same user if the amount of blood released from the first
`incision is insufficient for the test to be conducted.
`
`The Microtainer® is labeled as a single use device;
`however, its simple plunger mechanism wherein the lancet
`tip is withdrawn into a housing except when depressed,
`though effective. can be repeatedly depressed so that the
`Microtainer® device can be reused repeatedly. It does not
`provide any protection from transmission of bacteria or
`viruses that might result from reuse by another person or
`from accidental cuts resulting from mishandling after dis-
`posal. The Hemochron TenderfootTM can only be triggered
`once. and cannot be rearmed in the event of misfire or
`ineffective incision. There are a variety of other devices that
`
`2
`
`provide similar operating characteristics and similarly lack
`either safety features or some patient usability.
`These conventional devices therefore either provide for
`multi-use (including reuse when misfired), but do not pro-
`vide means for permanently disarming the device after use,
`or they limit use to a single triggering event and thereby help
`to prevent bacterial and viral contamination, but preclude
`reuse by the same patient if accidentally triggered or if the
`single incision does not yield enough blood for the intended
`test. These limitations are bewildering for the consumer who
`wants protection. but may be concerned about the costs of
`devices that through normal handling have become unus-
`able.
`
`They also present a problem for consumer self-test pro-
`viders as there may be a need to package two or more
`finger-stick devices with the self-test kit as a means to assure
`self-test kit usability and adequate blood sample. Heath care
`providers are concerned because of the ever increasing
`pressure to reduce costs at all levels. The proliferation of
`health care providers and consumer self-tests for various
`medical conditions makes such need even more urgent.
`Therefore. there is a need for a finger-stick device or lancet .
`thatxcan be rearmed or reset in the event of misfire or
`
`inelfective incision, but that can also be permanently dis-
`abled after effective use to prevent transmission of bacterial.
`viral. or other harmful agents to others.
`SUMMARY OF THE INVENTION
`
`The subject invention is a lancet or finger stick device
`operable to make a small incision into the vascular tissue at
`the finger tip, toe. baby’s heel area or other region of a
`patient from whom a small sample or drop of blood is
`needed. It provides a single-user finger-stick device having
`an autologous re-use feature. such that an individual (e.g. a
`health practitioner or the patient) can reset and reuse the
`device on the same patient in case of an accidental misfire
`prior to actual use or if the first incision does not provide a
`sufiicient self-test big sample. The inventive device and
`method also provide a disabling mechanism which the
`individual performs immediately prior to disposal of the
`used device. This combination provides optimum value and
`protection for the user, and anyone else who may ultimately
`come in contact with the disabled device.
`
`These features permit the user of a commercial self—test or
`professional use test to re-stick an individual’s fingertip in
`the event that the first try is inadequate. It also insures
`sterility of the unused unit and provides enhanced safety
`since the device cannot he accidentally fired or reused by
`another individual after being disposed of.
`In one embodiment of the invention. the device includes
`a housing with a hole at one end through which a sharp
`sterile lancet tip normally enclosed within the housing is
`able to extend. A lancet support body. also disposed within
`the housing, supports the lancet tip and is coupled to a
`resettable force means (such as a spring) in a retracted armed
`position, which stores energy and upon being triggered.
`releases the stored energy to move the lancet tip from a
`protected retracted location inside the housing, through the
`hole or aperture in the housing a predetermined distance into
`the patient’s finger. The force means also automatically
`retracts the lancet tip back into the housing immediately
`after forming the incision. A resettable latch is provided for
`latching the force means in an energy storing state once
`armed. and a resettable release means. such as a release or
`trigger button. is provided for releasing the latch to allow the
`force means to release the stored energy. and thereby to drive
`the lancet tip outwardly from the housing.
`
`ACTA EX. 1021-013
`
`ACTA Ex. 1021-013
`
`

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`5,741,288
`
`3
`‘These and other features of the invention will be apparent
`to those having ordinary skill in the art from the appended
`description and drawings.
`
`BRIEF DESCRIPTION OF THE DRAVVINGS
`
`FIG. 1 is a diagrammatic illustration showing a partial cut
`away perspective view of one embodiment of the inventive
`finger stick device in the activated or armed configuration
`ready for use.
`FIG. 2 is a diagrammatic illustration showing a partial cut
`away perspective view of the embodiment in FIG. 1 during
`operation at the stage Where the lancet tip is fully extended
`into a patient’s finger tip.
`‘
`FIG. 3 is a diagrammatic illustration showing a partial cut
`away perspective view of the embodiment in FIG. 1 after use
`and deactivation.
`
`FIG. 4 is a diagrammatic illustration showing a perspec-
`tive exterior view of a second embodiment of the inventive
`finger-stick device shown prior to first use.
`FIG. 5 is a diagrammatic illustration of a first end view of
`device particularly showing the protective cap covering the
`lancet tip. ‘
`FIG. 6 is a diagrammatic illustration of a second end view
`of the device particularly showing the activating plunger
`extending from an aperture in the device housing.
`FIG. 7 is a diagrammatic illustration showing an exploded
`partial cut away perspective view of the preferred embodi-
`ment of the inventive finger stick device in FIGS. 4-6.
`FIG. 8 is an illustration showing a plan View of the interior
`of the upper half housing.
`FIG. 9 is an illustration showing a plan view of the interior
`of the lower half housing.
`FIG. 10 is an illustration showing a sectional view
`through region B—B of the trigger assembly.
`FIG. 11 is an illustration showing a sectional View through
`region C—-C of the trigger assembly.
`FIG. 12 is an illustration showing a sectional View
`through region D——D of the lower housing half.
`FIGS. 13a—13e are illustrations of a prior-art lancet suit-
`able for use with the inventive finger-stick device.
`FIG. 14 is a diagrammatic illustration showing a pa11ial
`cut away view of the preferred embodiment of the inventive
`finger stick device in a pre-use configuration with the
`protective lancet tip cover still in place.
`FIG. 15 is a diagrammatic illustration of the preferred
`embodiment after removal of the protective lancet tip cover
`and just prior to device arming.
`FIG. 16 is a diagrammatic illustration of the preferred
`embodiment in the stage of being armed for use.
`FIG. 17 is a diagrammatic illustration of the preferred
`embodiment showing the lancet tip moving forward to
`puncture the patient’s skin.
`FIG. 18 is a diagrammatic illustration of the preferred
`embodiment showing the lancet tip at maxirnum penetration.
`FIG. 19 is a diagrammatic illustration of the preferred
`embodiment showing the lancet tip being automatically
`Withdrawn into the housing after puncture.
`FIG. 20 is a diagrammatic illustration of the preferred
`embodiment showing the lancet tip after withdrawal into the
`housing after skin puncture.
`FIG. 21 is a diagrammatic illustration of the preferred
`embodiment showing the activation plunger being twisted to
`break the frangible neck and disarm the device.
`
`4
`
`FIG. 22 is a diagrammatic illustration of the preferred
`embodiment showing the disarmed device.
`FIG. 23 is a diagrammatic illustration of a third alternative
`embodiment of the inventive finger-stick device showing a
`break-away latch trigger as a disarming means.
`FIG. 24 is a diagrammatic illustration of the third embodi-
`ment of the device showing an exemplary pull and twist
`removal of the break-away latch trigger.
`FIG. 25 is a diagrammatic illustration of the third embodi-
`ment of the device showing the disarmed device with the
`break-away latch/trigger arm removed.
`FIG. 26 is a diagrammatic illustration of a fourth alter-
`native embodiment of the inventive finger-stick device
`showing protective non—removable caps for insertion after
`effective use as a device disarming means.
`FIG. 27 is a diagrammatic illustration of the fourth
`embodiment showing insertion of one of two alternative
`protective non—removable caps.
`FIG. 28 is a diagrammatic illustration of the fourth
`embodiment showing the device in FIG. 27 after insertion of
`a non—removable protective cap.
`
`DESCRIPTION OF THE SPECIFIC
`EMBODDVIENT
`
`The subject invention is a lancet or finger stick device
`operable to make a small incision into the vascular tissue at
`an appropriate site. e.g. the finger tip, toe. heel of the foot or
`other similar region of the patient from whom a small
`sample or drop of blood is needed. For example, in the
`consumer diagnostic self-test market there are devices. such
`as blood glucose assay devices. cholesterol assay devices,
`and the like. that require a small sample of the patient’s
`blood to perform the particular diagnostic test. The sample
`may generally be one or a few drops of blood.
`The subject invention provides a finger-stick device hav-
`ing an autologous re-use feature, such that an individual (for
`example, a health practitioner or the patient him- or herself)
`can reset and reuse the device in case of a misfire or if the
`
`incision provides inadequate blood to obtain the
`first
`required blood sample amount, as well as a disabling mecha-
`nism which the individual performs prior to disposal of the
`used device. This combination provides optimum value and
`protection for the user, patient or other who may intention-
`ally or accidentally come into contact with the used device.
`For further understanding of the invention. the drawings
`will now be considered. In FIG. 1 there is shown a simple
`embodiment of the inventive finger stick device 22. A
`generally cylindrical outer housing 23 has a first round
`aperture 24 at a first end and a second round aperture 25 at
`the opposite end. and defines a cylindrical inner bore 26
`‘having a recessed elongated guide slot 27 therein. A cylin-
`drical lancet body 28 having a diameter slightly smaller than
`that of inner bore 26 is slidably disposed within bore 26.
`Lancet tip 29 is preferably stainless steel and is formed
`integral to and extends from plastic body 28 a predetermined
`distance. Abias spring 30 which provides the force to drive
`lancet tip 29 into the patient’s skin is fixedly connected to a
`rear end surface of lancet body 28 opposite to the lance tip
`and to housing 23 such as with a cupped ‘depression 34 for
`receiving a coil of spring 30 proximate second aperture 25
`with slot 35 formed into the inner surface of housing 23. The
`spring 30 may also be attached by any other conventional
`fastening method such as by gluing. molding. and the like.
`A plunger 31 provides retraction means and is removable
`from the lance body 28 at frangible or breakable necked
`
`ACTA EX. 1021-014
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`ACTA Ex. 1021-014
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`5
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`5,741,288
`
`region 33 extends from the rear end of the lance body,
`concentric with and through bias spring 30, and out second
`aperture 25, where it is accessible to a user’s finger grasp.
`The user pulls the plunger away from the housing to
`compress spring 30 and thereby load energy into the spring
`for later release. The housing, lancet support body, latchl
`release arm and other components may conveniently be
`fabricated from plastic. The spring and lancet tip are pref— ‘
`erably made from metal. Corresponding elements in each
`figure are the same unless otherwise indicated. Reference
`numerals have been left off some drawings to more clearly
`present each embodiment.
`A spring loaded latch and latch release button 32 is
`connected to body 28 and slidably disposed within guide slot
`27. Latch and latch release button 32 serves several func-
`
`tions including preventing rotation of lancet body 3 within
`bore 26, latching the body 28 in an armed condition, and
`providing a release button for the latch itself as described
`hereinbelow.
`
`Advantageously a once-removable hard protective cap or
`seal 36 is disposed proximate the first aperture 24 to protect
`the user from the sharp lance tip 29 prior to use. to preserve
`tip sterility, and to serve as an indication that the device is
`new and has not been used previously.
`This embodiment of the finger-stick device 22 has three
`static states or configurations. and operates through a con-
`tinuum of dynamic configurations between these static
`states. During storage and when the protective cap 36 is first
`removed, the spring 30 is in a relaxed non-compressed,
`non-extended equilibrium state, and the lance body 28 and
`integral tip 29 are maintained within the housing and from
`contact with the cap 36 by the stiffness of bias spring 30.
`With reference to FIG. 1 (which shows the device 22 in
`the armed condition), just prior to use, the inventive device
`22 is armed by pulling back on plunger 31 to compress bias
`spring 30 until spring loaded latch button 32 can extend
`through a third hole or aperture 37 in housing 23, thereby
`preventing further rearward retraction and latching the
`spring 30 in compressed condition. The latch arm 98 is
`advantageously formed from a stiff elastic material so as to
`have a spring like quality. The cross sectional area of the arm
`is adjusted in concert with the material properties to provide
`the desired latching force. This is the activated or armed
`static condition of the device.
`
`During use to create an incision in a patient, the device is
`placed in contact with the patient’s finger tip 201 so that
`when the lance tip extends through the first aperture 24
`(described below), it will puncture the skin to a predeter-
`mined depth generally between about 0.5 mm and about 5
`mm. and more typically between about 1 mm and about 3
`mm. Latch button 32 is depressed so that the latch button
`exits the third aperture 37 into guide slot 27 which originally
`received and held the latching button or tab 32. thereby
`releasing the latching button 32 so that the heretofore
`compressed bias spring 30 is allowed to expand and accel-
`erate the lance body 28 and tip 29 forward toward and
`through the first aperture 24.
`Movement of the lance body 28 forward is limited by a
`movement limit stop 38. here provided by a thickened
`portion of the housing 2.3 proximate first aperture 24, which
`limits the forward movement of lancet body 28. The first
`aperture 24 (typically round) has a diameter that is smaller
`than the abutting dimension (e.g. diameter) of the lance body
`28 so that the lance body 28 cannot move through aperture
`24 beyond the movement limit stop. The thickness of this
`limit stop 38 is chosen in concert with the length of the lance
`
`tip 29 to provide the desired skin puncture depth. FIG. 2
`illustrates the condition of device 22 when the lancet tip is
`at the limit of forward movement into the patient’ s finger tip.
`The length of bias spring 30 is selected such that when the
`front surface of lance body 28 reaches the stop 38, the bias
`spring 30 is in an extended condition and therefore irnme-
`diately contracts, thereby retracting the lancet tip 29 from
`the patient’s finger back into the housing 23.
`If the user accidentally misfires the device 22. or does not
`obtain a satisfactory incision to draw suflicient blood. the
`device 22 may be reset or reactivated by again pulling the
`plunger 31 rearward as before, until tab 32 latches into
`aperture 37, and re—depressing the latch release button. This
`arming-releasing-rearming can be done multiple times until
`satisfactory results are obtained.
`As illustrated in FIG. 3, once a satisfactory sample has
`been obtained, the device is permanently deactivated by
`breaking the plunger 31 from the remainder of the lancet
`body. Such breaking is easily accomplished by providing a
`thin necked coupling 33 between plunger 31 and lancet body
`28 that is strong enough to withstand multiple pulls during
`the one or more activations that a single device 22 may
`encounter, but that is sufliciently fragile that it may be
`broken when desired, such as by providing a frangible
`necked connection 33 between the body 28 and the plunger
`31 such that a twisting motion permanently separates the
`two components.
`This simple embodiment having been described, an alter-
`native and preferred embodiment having additional features
`is now described relative to FIGS. 4-22. In FIG. 4 there is
`shown an external perspective view of a preferred embodi-
`ment of the inventive finger-stick device. FIGS. 5 and 6
`show end plan views of the exterior of device 40, and FIG.
`7 is an illustration of an exploded partial cut away View of
`device 40. FIGS. 8 and 9 show internal plan views of upper
`and lower cover 23a and 23b. With respect to these figures,
`the device 40 has a tubular outer housing 23, here formed
`from two pieces (23a, 23b) which surround the internal
`assembly and provides protection and ease of handling for
`the device. The housing is conveniently formed in two half
`pieces such that
`the assembled components are placed
`within the interior boundaries of the two pieces, then the two
`halves are aligned, such as with sets of mating registration
`pins and sockets. and then connected such as with glue, by
`welding, with clips, or other conventional fastening metl1—
`ods. While the housing 23 may be any shape and formed of
`any material, the housing is conveniently in the form of an
`elongated cylindrical shaped tube fabricated from high
`impact plastic or polymeric material with first aperture 24
`and second aperture 25 provided at opposite ends of the tube
`shaped housing. and a third aperture 37 provided through the
`housing medial to the two opposing ends through the
`cylindrical wall of the housing.
`The housing forms a substantially cylindrical inner tube
`or bore 26 which also advantageously includes a generally
`elongated rectangular expanded region 27 within the hous-
`ing cavity and aligned along the cylindrical axis of the
`housing, and which forms a protuberance 44 on the exterior
`wall adjacent the third aperture 37. The functionality of
`these apertures and protuberances are described below. Such
`cylindrical shape readily provides internal support for the
`functional components and provides an easily handled and
`articulated form for the user of the finger-stick device.
`The housing forms a symmetrical cylindrical
`interior
`chamber 26 having interior wall 46 through which lancet
`unit 62. trigger assembly 72. and spring 70 are connected to
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`ACTA EX. 1021-015
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`ACTA Ex. 1021-015
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`7
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`8
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`5,741,288
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`each other and slidably disposed relative to the housing.
`Axial alignment of trigger assembly 72 and lancet unit 62
`which is coupled to trigger assembly 72 within the cylin-
`drical bore 26 is maintained by first cylindrical slider 74 and
`second cylindrical slider 78 which are sized to slidably fit
`bore 26. During operation of the device 40. maximum
`rearward movement (away from first aperture 24) of trigger
`assembly 72 is limited by abutment of the rear surface 76 of
`slider 74 with an inwardly protruding first set of stops 82
`(82a, 82b). In analogous manner. maximum forward move-
`ment (toward first aperture 24) of trigger assembly 72 is
`limited by abutment of the front surface 80 of slider 78 with
`an inwardly protruding second set of stops 84 (84a, 84b).
`Operation of these cylindrical sliders and stops is described
`in more detail hereinafter. These first and second sets of
`stops are conveniently provided by upper and lower housing
`half aligmnent pins and mating sockets, but separate struc-
`tures for each function could alternately be provided.
`Trigger assembly 72 is preferably formed on a single
`plastic molded part and includes a T-shaped body portion 86.
`a lancet tip receiver section 92, sliders 74 and 78, plunger 71
`including frangible neck section 73. a spring fastening clip
`119 and a latch and release mechanism which includes latch
`arm 98 and latch/release button 99. (See FIG. 11.) The
`trigger assembly 72 advantageously includes a T-shaped
`section 86 that mates to a T-notched region 88 of the housing
`23. (See FIG. 12.) The T-shaped section 86 is slidably mated
`to the T-notched region 88 and prevents rotation of the
`trigger assembly about the cylindrical axis of the assembly
`and housing 23. An elongated plunger 71 extends rearward
`toward and through second aperture 25 to provide means for
`the user to pull the trigger assembly 72 rearward to compress
`spring 70 to load energy into the spring. Plunger 71 is
`connected to the main body of the trigger assembly by a
`frangible neck section 73 that is strong in tension. so that
`normal pulling to arm the device does not break the neck
`section. but can be broken with a deliberate rotational twist.
`Preventing rotation of the internal components (e. g.
`the
`T-shaped body section 86) relative to the housing 23 is
`advantageous for operation of safety features of the device
`including initial activation of the device 40 prior to use. and
`deactivation by breaking ofl plunger 71 after use prior to
`disposal as described hereinafter.
`Lancet unit 62 comprises a sharp sterile lancet tip 64 of
`the type intending for plunge incisions of the patient’s skin,
`and a supporting lancet body 66. Lancet unit 62 also
`advantageously includes a protective cover or cap 68 over
`tip 64 which is connected to lancet body 66 by a frangible
`neck region 67. Cap 68 preserves sterility until the cap is
`removed. prevents accidental cuts or punctures during han-
`dling prior to use. and serves as an indication to the user that,
`when intact. the device has not been used. The frangible
`neck region 67 is easily broken by twisting cap 68 to thereby
`expose lancet tip 64. Recall that T-shaped section 84 in
`combination with T-shaped slot 88 prevents rotation of the
`internal components relative to body 23. The inventive
`device 30 provides special operative features. such that
`when the cap 68 is removed (by safe user movement away
`from the sharp lancet tip) from the tip 64, the tip 64 is
`immediately and automatically withdrawn into the housing
`to prevent contact that could compromise sterility and to
`prevent accidental cuts or punctures. This feature is
`described hereinafter relative to FIGS. 14-22. While. vari-
`ous lancet units 62 of the type described may be used, the
`lancet unit described in U.S. Pat. No. 3.358.689 to Higgins
`in particular. for example. may be used.
`Lancet unit 62 is adapted to fixedly mate to a lancet body
`receiving notch 92 thereby fixing the position of the lancet
`
`tip with respect to the trigger assembly 72 and with respect
`to the inner and outer surfaces of housing 23 by the nature
`of operation of cylindrical sliders 74.78 and stop sets 82,84.
`Lancet body 66 and receiving notch or cup 92 advanta-
`geously provide a snug fit together so that the lancet tip
`position is properly maintained. Advantageously. one or
`both of the body 66 and receiving cup 92 include ridges 94
`and/or notches 96 such that a positive lock is established
`between the body and the notch. Alternatively. the receiving
`cup 92 may include relatively sharp molded ridges that can
`slice into the somewhat soft polymeric body of lancet unit 62
`to thereby fix the location of the body 62 in the notch 92. Of
`course, the lancet body and lance tip may be formed integral
`with the body of the trigger assembly 72 such as in a single
`plastic molding, thereby eliminating the need for separate
`alignment and assembly. However. the use of conventional
`commercial lancet tips separate from but attachable to the
`trigger assembly 72 is preferable because the tips are readily
`available. are relatively inexpensive because of the large
`volumes made and sold. and because their use eliminates the
`need for separate and relatively more expensive sterile
`production facilities for the other stick-finger device com-
`ponents.
`Trigger assembly 72 also includes a latching arm 98 and
`a latch release button 99. the operation of which will be
`described hereinafter with reference to FIGS. 14-22. FIGS.
`14-22 are partial cut a way diagrammatic illustrations that
`show the overall operation of the inventive finger-stick
`device 40 as well as the function of internal components.
`With reference to FIG. 14.
`there is shown a partial
`cut-a-way View of the inventive device prior to use. The
`protective cap 68 is still attached to the lancet body 66 via
`the frangible neck section 67 and serves as a positive
`indication to a user that the device 40 has not been used and
`that the lancet tip 64 underlying the cap is sterile. Plunger 71
`is in a first start position and has not been pulled rearward.
`Trigger button 99 is protected under housing protrusion 44
`and its absence from View serves as an additional indication
`that the device has not been activated and is not immediately
`available to the user to trigger the device.
`With reference to FIG. 15. the user has grasped protective
`cap 68 and while holding housing 23. twisted the cap until
`the frangible neck section 67 fractures. As the neck section
`begins to fracture. a slight tension from spring 70 urges the
`trigger assembly 72 rearward