United States Patent
`Ryder et al.
`
`[19]
`
`A
`
`[11] Patent Number:
`[45] Date of Patent:
`
`4,735,203
`Apr. 5, 1988
`
`[54] RETRACIABLE LANCET
`
`[75]
`
`Inventors: Francis E. Ryder; Stephen P. Lisak;
`Harold L_ pmdy, all of Arab’ Ala.
`
`4,469,110 9/1984 Slama ........................ .. 128/3 14
`4,628,929 12/1986 Intengan et a1. .................. .. 128/314
`_
`V
`Primary Exammer—Dalton L. Truluck
`Assistant Examiner—F. Wilkens
`
`[731 Asslglleei RN91‘ Illt€|’ll3tl0l|81 C°l'll0l'3tl0l1s
`Arab, Ala-
`
`Attorney, Agent, or Firm—Trex1er, Bushnell, Giangiorgi
`& Blackstone, Ltd.
`
`[2]] Appl. No.: 941,164
`
`[57]
`
`ABSTRACI
`
`[22] Filed:
`
`Dec. 12, 1986
`
`[ii]
`[58]
`[
`1
`
`[56]
`
`References Cited
`
`-
`
`A retractable, non-reusable bleeding time lancet appara-
`tus comprises a housing having an end opening, a blade,
`%i4 """""""""""""""""31: and a carrier for fixedly mounting the blade and
`F,‘ la
`“““ """"""""128/314 ’3l5 329 R
`mounted in the housing for sliding motion toward and
`le 12%/3 134_137_ ’30/3’66 367’
`away from the end opening. A resilient biasing member
`’
`’
`’
`’
`’
`is mounted in the housing in a prestressed condition and
`’
`155
`is operatively coupled for selectively urging the carrier
`for achieving sliding motion toward and away from the
`housing end opening. A non-resettable release member
`normally retains the biasing member in its prestressed
`condition and is selectively activatable for releasing the
`resilient biasing member to urge the carrier in a sliding
`motion for projecting at least a cutting edge of the blade
`through the end opening. Cooperating surfaces on the
`housing and carrier define respective limits of sliding
`.
`.
`.
`motion of thehcarrier corresponding to extended and
`retracted positions of the blade cutting edge relative to
`the housing end opening. The resilient biasing member
`is operatively engaged with the carrier for achieving a
`compound sliding movement of the carrier comprising
`an initial portion including extension of the carrier for
`projecting the blade cutting edge outwardly of the
`housing end opening, immediately followed by a second
`portion including retraction of the carrier for retraction
`.
`.
`.
`of the blade cutting edge back into the housing.
`
`'
`
`U'S' PATENT DOCUMENTS
`4.450 4/1846 Gemrig .
`55520 5/1356 C3P€W€11
`5772756 7/1901 Caldweu -
`Eggigkué
`’
`’
`g
`2,864,370 9/1955 Alvos .
`_
`3,358,689 12/1957 Higgins _
`3,741,197 6/1973 Sanz et al. ........................... 123/2 F
`3,903,337 9/1975 Antoshkiw ... .. .
`. . ... 128/221
`4,078,552 3/1978 Chen et al.
`......
`128/2 G
`4,139,011
`2/1979 Benoit et al.
`128/329
`4s203:445 5/1930 H_°f_€“ 6* 31-
`123/329
`4,358,539 ll/1982 Blttlngs .......
`435/301
`4375'81s
`3/1983
`128/314
`4’379’456 4/1983 Come” et a1‘ "
`128/314
`4,388,925
`6/1983 Burns
`128/314
`4,445,510 5/1984 Rlgby
`123/329
`.
`4,449,529
`5/1984 Bums et
`128/314
`4,452,243
`6/1984 Leopoldi et al.
`................... 128/314
`
`‘ .
`, HF] E
`'
`ll
`
`20 Claims, 5 Drawing Sheets
`
`ACTA EX. 1022-001
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`ACTA Ex. 1022-001
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`

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`U.S. Patent
`
`Apr.5,19ss
`
`
`
`2
`
`Sheet tors
`
`4,735,203
`
`=2: EL@7/ 7-4 M élll /I 11/
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`94 ~ [0
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`ACTA EX. 1022-002
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`ACTA Ex. 1022-002
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`

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`U.S. Patent
`
`Apr. 5, 1988
`
`Sheet 2 of 5
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`4,735,203
`
`ACTA EX. 1022-003
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`ACTA Ex. 1022-003
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`

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`U.S. Patent % Apr. 5, 1988
`
`Sheet 3 of 5
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`ACTA Ex. 1022-004
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`

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`U.S. ‘Patent
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`_m...A
`
`oo915,
`
`00
`
`Sheet 4 of 5
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`ACTA EX. 1022-005
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`ACTA Ex. 1022-005
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`

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`U.S. Patent
`
`'Apr.5,1988
`
`Sheet 5 of5
`
`4,735,203
`
`[L
`.1
`.A1-HIIITIIIM
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`
`
`Hllllllllllllllllllllllflllllllllll‘;«0
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`ACTA EX. 1022-006
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`ACTA Ex. 1022-006
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`

`
`1
`
`4,735,203
`
`2
`
`RETRACFABLE LANCET
`
`BACKGROUND OF THE INVENTION
`
`The invention concerns a lancet assembly, and more
`particularly concerns an automatically retractable non-
`reusable lancet assembly.
`Sharp pointed or blade-like lancets, as they are gener-
`ally known in the art, are employed to make a quick
`puncture or penetration of the skin of a patient to cause
`a small flow of blood. Various tests require a relatively
`small amount of blood, for example a drop smeared
`upon a slide or the like for microscopic viewing, such
`that the amount of blood flowing from a finger prick of
`this type is normally sufficient. Also, various bleeding
`time tests are often employed in which the time running
`from the puncture of the skin until the cessation of
`blood flow is measured. Such bleeding time provides a
`measure from which, by reference to tables or the like,
`the clotting factors and/or other such relevant informa-
`tion concerning a patient’s blood chemistry can be esti-
`mated. One such bleeding time test, referred to in the art
`as the Ivy technique, determines the rate of blood loss
`or bleeding time. One of the prior art blade-like punc-
`turing devices developed for use in this test is shown in
`U.S. Pat. No. 4,078,552 to Chen et al.
`Because the nerve endings in the finger tip area are
`quite sensitive, even such minimal skin punctures may
`be quite irritating and/or painful. In order to minimize
`the discomfort associated with such tests, it is desirable
`to make the puncture or penetration of the skin by the
`lancet as rapid and short-lived as possible. Moreover, in
`order to achieve some degree of standardization and
`repeatability as to the above-described bleeding time
`type of test, it is desirable that the lancet be designed so
`that the speed, effective time of penetration, and depth
`of penetration are standardized and repeatable from one
`lancet device to the next.
`Various spring loaded lancets are known, some of
`which provide spring-loaded firing for standardization
`of the forces, velocities, and depth of penetration, and
`some of which provide spring-loaded, retractable fea-
`tures. For example, such spring-loaded and/or retract-
`able lancets are shown in US. Pat.
`to Burns, Nos.
`4,375,815 and 4,388,925 as well as in the U.S. Pat. to
`Burns No. et al, 4,449,529.
`The retractable feature of some of these lancets is also
`desirable, in that it prevents reuse of the lancet, and
`requires disposal of the same after but one use. This is
`important for at least two reasons: firstly, for health and
`sanitary reasons it is inadvisable to reuse the same lancet
`on a second patient; and secondly, some technicians
`might reuse the blade of a preloaded or spring-loaded
`lancet after an initial firing thereof without restressing
`or preloading the spring, but rather by merely manually
`making the puncture, thus failing to take advantage of
`the preloaded, controlled force and velocity of the ac-
`tion thereof. In the second case, some of the prior art
`devices leave the cutting edge or point extended from
`the body or housing of the lancet after firing and may or
`may not permit reloading or recompression of the
`springs or other members which accomplish firing.
`Some other lancets utilize a multiple spring arrange-
`ment, such as those shown in some of the Burns or
`Burns et al patents noted above. However, such assem-
`blies are relatively complex and require a number of
`interfitting parts which are relatively difficult to manu-
`facture and accurately assemble. Moreover, the use of
`
`5
`
`15
`
`20
`
`40
`
`55
`
`65
`
`two springs, one for firing of the lancet point or blade
`and a second for retracting the same after firing, pres-
`ents a number of problems in accurately reproducing
`the tensile strengths and behavior, both in compression
`and upon release, of two oppositely acting springs.
`These factors can be difficult to uniformly reproduce in
`practice, at least in a relatively inexpensive, disposable
`product. This difficulty is due not only to the problems
`in selecting and properly mounting and pretensioning
`the springs themselves, but also in the difficulty of main-
`taining uniforruity of housing or other casing parts
`within which the springs are mounted, maintaining
`accurate dimensions, controlling frictional forces, and
`the like.
`In order to overcome the foregoing problems and
`address the foregoing considerations, we have devised a
`novel retractable, non-reusable bleeding time lancet
`apparatus. Our apparatus comprises a housing having an
`end opening, a blade, and a carrier for fixedly mounting
`the blade and mounted in the housing for sliding motion
`toward and away from the end opening. A resilient
`biasing member is mounted in the housing in a pre-
`stressed condition and is operatively coupled for selec-
`tively urging the carrier for achieving sliding motion
`toward and away from the housing end opening.
`A non-resettable release member normally retains the
`biasing member in its prestressed condition and is selec-
`tively activatable for releasing the resilient biasing
`member to urge the carrier in a sliding motion for pro-
`jecting at least a cutting edge of the blade through the
`end opening. Cooperating surfaces on the housing and
`carrier define respective limits of sliding motion of the
`carrier corresponding to extended and retracted posi-
`tions of the blade cutting edge relative to the housing
`end opening.
`The resilient biasing member is operatively engaged
`with the carrier for achieving a compound sliding
`movement of the carrier comprising an initial portion
`including extension of the carrier for projecting the
`blade cutting edge outwardly of the housing end open-
`ing, immediately followed by a second portion includ-
`ing retraction of the carrier for retraction of the blade
`cutting edge back into the housing.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The features of the present invention which are be-
`lieved to be novel are set forth with particularity in the
`appended claims. The organization and manner of oper-
`ation of the invention, together with further objects and
`advantages thereof, may best be understood by refer-
`ence to the following description taken in connection
`with the accompanying drawings in which like refer-
`ence numerals identify like elements, and in which:
`FIG. 1 is a perspective view of a retractable lancet in
`accordance with the invention;
`FIG. 2 is an enlarged, developmental view, taken
`generally along the line 2-2 indicated in FIG. 1, and
`illustrating details of the internal construction thereof}
`FIG. 3 is a developmental View taken generally along
`the line 3-3 of FIG. 2;
`FIG. 4 is a view similar to FIG. 2 and illustrating an
`initial portion of a compound movement of the lancet
`device of the invention upon firing thereof;
`FIG. 5 is a view similar to FIGS. 2 and 4- and illustrat-
`ing a second portion or retraction portion of the com-
`pound movement of the lancet device of the invention
`upon firing thereof;
`
`ACTA EX. 1022-007
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`ACTA Ex. 1022-007
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`

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`4,735,203
`
`4
`will indicate that the device has been used and is to be
`discarded. This acts as a further back-up feature to the
`V nonresettable nature of the device as described herein
`However, it will be seen that depression of a project-
`ing outer end 40 of the clip member 38 will break tab 41
`and release the projecting post or trigger member 37
`from its retained condition to permit this prestressed
`spring 34 to generally uncoil or move toward a relaxed
`position thereof. When the spring 34 is thus released
`from its prestressed condition, it urges the carrier 30
`initially toward the opening 32 and an extended position
`thereof wherein the blade 28 or at least an endmost
`
`3
`FIG. 6 is an exploded view similar to FIG. 3, and
`illustrating the assembly of the components of the lancet
`of the invention;
`FIG. 7 is a side elevation‘ of a preassembled spring
`and blade carrier portion of the lancet apparatus of the 5
`invention, somewhat enlarged from the previous views;
`FIG. 8 is a view similar to FIG. 2, of a retractable
`lancet in accordance with a second embodiment of the
`invention, in its assembled condition and prior to use
`thereof;
`FIG. 9 is a view of the embodiment of FIG. 8, and in
`similar fashion to FIG. 4, illustrating a first portion of
`the compound motion of the blade thereof;
`FIG. 10 is a view of the embodiment of FIGS. 8 and
`9, and in similar fashion to FIG. 5, illustrating the sec- 15
`0nd or retraction portion of the compound motion
`thereof;
`FIG. 11 is a partial sectional View taken generally in
`the plane of the line 11-11 of FIG. 8, and
`FIG. 12 is an enlarged end view of a cam member of 20
`the embodiment of FIGS. 8-11.
`
`DETAILED DESCRIPTION OF THE
`ILLUSTRATED EMBODIMENT
`
`Referring now to the drawings, and initially to FIG. 25
`I, a retractable, nonreusable bleeding time lancet in
`accordance with the invention is designated generally
`by the reference numeral 20. In its fully assembled form
`as viewed in FIG. 1, the lancet 20 includes a housing 22
`which, in the preferred form illustrated, is comprised of 30
`two similar and complementary shell portions 24, 26
`each of which define substantially one-half of the hous-
`ing, and more particularly define respective front and
`rear halves thereof. Aside from housing 22, little else is
`visible in FIG. 1, which it should be noted is shown
`greatly enlarged over the actual size of the apparatus. In
`use, the assembled lancet generally appears substantially
`as seen in FIG. 1. That is, the puncturing or blade mem-
`ber thereof is only fired or ejected therefrom for a rela-
`tively short time, on the order of a fraction of one sec-
`ond, and is immediately retracted, such that it is difficult
`even to visually observe the brief extension of the blade
`in practice.
`Referring now also to FIGS. 2 and 3, these further
`enlarged views of lancet 20 further reveal a blade or
`blade means 28 and carrier means 30 which fixedly
`mounts the blade 28. The carrier 30 is mounted in the
`housing 22 for slidable movement generally toward and
`away from an end opening 32 of the housing, through
`which the blade 28 briefly projects when the device is
`operated, to puncture the skin of a patient. Resilient
`biasing means which,
`in the illustrated embodiment,
`comprises a single coil-type spring 34, is mounted in the
`housing 22 in a prestressed condition as will be more
`fully explained . hereinbelow. This resilient biasing
`means or spring 34 is further operatively coupled with
`the carrier 30 for resiliently selectably urging the same
`in a sliding motion toward and away from the housing
`end opening.
`A non-resettable release means in the illustrated em-
`bodiment comprises a projecting post or trigger mem-
`ber or portion 37 on the carrier 30 and a cooperating
`clip member 38. These members are operatively cou-
`pled for normally retaining the biasing means or spring
`34 in its prestressed condition. A frangible tab 41 is
`molded into one or both housing halves 24, 26 in a
`position so as to generally overlie the outwardly pro-
`jecting end of clip 38. Absence of this breakaway tab
`
`cutting edge 36 thereof extends or projects through the
`opening 32 for puncturing the skin of the patient.
`The housing 22 and carrier 30 further have cooperat-
`ing means formed thereon in the form of respective
`abutting or stop surfaces 42, 44 and 46, 48 for defining
`respective limits of sliding motion of the carrier relative
`to the housing. These limits of motion correspond to the
`retracted position of the blade shown in FIGS. 2 and 3
`and the extended or projecting position shown in FIG.
`4, to which reference is also invited.
`In accordance with the invention and referring now
`also to FIGS. 4 and 5, the sliding motion of the carrier
`caused by release of the spring 34 is a two-part or com-
`pound type of motion This motion comprises an initial
`portion including extension or urging of the carrier 30
`in the direction of opening 32 for extension or projec-
`tion of the blade 28 or at least the cutting edge 36
`thereof exteriorly of the housing, as illustrated in FIG.
`4. A second portion of this motion immediately follows
`the extension shown in FIG. 4, and this second portion
`comprises retraction of the carrier 30 for corresponding
`retraction of the blade cutting edge 36 back into the
`housing. This second portion of the compound motion
`is illustrated in FIG. 5. It will be noted that the novel
`coil spring arrangement in accordance with the inven-
`tion provides this compound, or serial, bi-directional
`sliding motion as it travels from the prestressed condi-
`tion illustrated in FIG. 2, to or at least toward a relaxed
`condition thereof, as illustrated in FIG. 5. That is, while
`it is not necessary that any tension or stress remain upon
`the spring when it assumes the position in FIG. 5, some
`amount of tension or stress may, nonetheless, remain
`without departing from the invention.
`Turning now more particularly to the details of the
`preferred embodiment illustrated in FIGS. 1 through 7,
`the coil spring comprises a helical body portion 50 and
`at least one outwardly projecting free end portion or
`arm 52. In the illustrated embodiment a second, oppo-
`site outwardly projecting free end or arm 54 is also
`provided. Operatively engaging the spring or biasing
`means for achieving the above-described motion of the
`carrier during release of the spring from its tensioned or
`prestressed condition shown in FIG. 2, are the first
`abutment surface 42 described previously and a second
`abutment surface 56. This second abutment surface 56
`comprises a projecting rim or rib portion of an interior
`of the housing 22 which defines a surface which is gen-
`erally parallel and spaced from, and mutually inwardly
`facing, with respect to surface 42. The surface 56 is
`relatively closer to end opening 32 than the first abut-
`ment surface 42.
`The means for operatively engaging the spring fur-
`ther include a compartment 60 formed within the car-
`rier 30 for receiving or mounting the body portion 50 of
`the spring. This compartment has a floor or lower sur-
`
`ACTA EX. 1022-008
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`4,735,203
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`face portion 62 which also abuts the opposite free end
`or arm 54 of the spring.
`Accordingly, as best appreciated upon viewing in
`sequence, FIGS. 2, 4 and 5, initially, as shown in FIG.
`2, the free end or arm 52 of the spring abuts housing
`surface 42. Upon release of the clip 40, this arm 52
`continues to abut and push against fixed wall or surface
`42 so as to thereby drive the remainder of spring and the
`carrier 30 in which the body 54 is mounted generally
`downwardly or toward the end opening 32. The effec-
`tive projection or length of arm 52 is selected to result
`in extension of the cutting portion 36 of the blade 28
`outwardly of the opening 32 in the housing when the
`arm reaches a generally fully extended or substantially
`vertically oriented position relative to the housing and
`surface 42, as illustrated in FIG. 4.
`In order to permit some compliance or “play” of the
`spring to assure clearance of the arm 52 relative to
`surface 42 during firing, a last or outermost coil 63 of
`the spring extends outwardly of the floor or lower sur- 20
`face portion 62 of the compartment 60. This allows for
`some manufacturing variations or tolerances in the
`length of the arm 52 and in the thicknesses and relative
`locations of the respective stop surfaces 42 and 56. That
`is, this compliance or play allowed by the projection of 25
`the coil 63 outwardly of the housing floor 62 permits
`this last coil to deform downwardly somewhat as the
`arm 52 rotates in engagement with surface 42 and pre-
`vents the arm from “hanging up” on surface 42.
`Thereafter, the arm continues in motion, as indicated
`by arrows 64, continuing to release the tension or pre-
`stressing forces upon the spring until arm 52 comes into
`engagement with the opposite or lower abutment sur-
`face or rib 56. Thereupon, the arm 52 tends to move in
`the direction that will produce a relaxed state for the
`spring 34. In the condition shown in FIG. 5, the two
`arms 52 and 54 extend substantially in a straight line or
`180 degrees opposite relative to the body 50 and at
`either end thereof.
`It will be noted, however, that in order to achieve
`this last position (FIG. 5), the body of the spring 50
`must again be drawn somewhat upwardly from the
`position illustrated in FIG. 4. This results in the carrier
`30 being drawn upwardly with spring body 50 since the
`latter is held mounted in compartment 60 within the
`carrier. This motion is indicated generally by arrow 66
`in FIG. 5. This in turn results in retraction of the blade
`28, or at least the cutting edge 36 thereof back interiorly
`of the opening 32 and within the housing.
`It should be noted that as the entire mechanism in-
`cluding the spring and carrier and the trigger projection
`or post 37, as well as blade 28, are entirely within the
`housing at the end of firing or release of the spring as
`shown in FIG. 5. No part or parts are accessible to
`permit resetting of the assembly to the condition shown
`in FIG. 2. In this regard, it will be seen that the trigger
`post and clip 38 cooperate by means of a pair of notches
`or slots 70 formed in the trigger post and a cooperating
`elongate slot 72 formed in the clip 38 which defines
`shoulders for engaging the slots 70. When the clip 38 is
`depressed by means of manual activating tab 40 gener-
`ally to the right as shown in FIGS. 2, 4 and 5, the grip-
`ping slot 72 of clip 38 is pushed out of engagement with
`grooves or slots 70 and an enlarged through opening
`portion 74 of the clip is brought into registry with post
`37. This permits the post 37 to travel freely through
`opening 74 in response to the unwinding motion of the
`spring 34. Moreover, aside from tab 40 all of the forego-
`
`6
`ing parts are inaccessible from the exterior of the hous-
`ing to prevent any attempt to reset or reuse the device,
`or to later force the blade 28 back outwardly of opening
`32.
`
`_
`
`In this latter regard, the spring 52, although in a re-
`laxed or nearly relaxed state, reliably holds the blade in
`the retracted position shown in FIG. 5.
`Preferably,
`the coil spring 34 is selected and/or
`formed so as to provide a predetermined controlled
`amount of force and acceleration to the blade for main-
`taining a controlled amount of force and time of contact
`of the blade cutting edge with the skin of the patient.
`Also, the amount of extension of the blade relative to
`the housing shown in FIG. 4 is selected to achieve the
`desired depth of penetration of skin to carry out the
`bleeding time tests in accordance with the standard
`so-called Ivy technique.
`‘
`In accordance with a further feature of the invention,
`and referring now also to FIGS. 6 and 7, a novel ar-
`rangement is provided for simplifying and facilitating
`assembly of the lancet device of the invention. Initially,
`the carrier means 30 will be seen to be configured for
`receiving the blade 28 in a generally snap-on fit arrange-
`ment, being provided with a blade-receiving fitting
`arrangement 80, generally complementary in form for
`receiving blade 28 which, as best viewed in FIGS. 2, 4
`and 5, has a through aperture 82, for this purpose. Addi-
`tionally, an overhang portion of the fitting 80, desig-
`nated generally at reference numeral 84, overlies and
`engages a top surface of the blade 28 to hold the same
`firmly in engagement with the carrier 30.
`In accordance with a feature of the invention, the
`spring-receiving compartment 60 includes a generally
`downwardly depending lip portion or retaining portion
`86 which will be seen to have a downwardly flared,
`ramped or cam surface 88. Upon initial assembly or
`pre-assembly of the spring 34 with the spring-receiving
`compartment 60, the free end 52 of the spring is pre-
`stressed in the manner shown in FIGS. 6 and 7 and
`
`placed entirely within the compartment 60 and behind
`the retaining lip 86. This greatly facilitates assembly of
`the now preassembled carrier, blade and spring with the
`two halves or shells 24, 26 of the housing 22. Moreover,
`the clip 38 is also preassembled with the trigger post 37
`of the carrier prior to assembly thereof with the housing
`halves or shells 24, 26.
`Cooperatively, one of the housing halves or shells,
`and in the illustrated embodiment the shell or half 24, is
`provided with a loading means in the form of a project-
`ing pin or post 90 which is configured and located for
`engaging and urging the spring free end 52 back out-
`wardly of the lip 86 upon assembly of the housing with
`the carrier. The ramp-like or cam-like nature of the
`surface 88 of the lip 86 facilitates the disengagement of
`spring end 52 in this regard. Upon this initial movement
`of the spring end 52, the same is free to engage the
`abutment surface 42 as previously described with refer-
`ence to FIGS. 2-4.
`.
`Upon assembly, it will be seen that the trigger post 36
`extends through an aperture 92 provided therefor
`through the abutment surface or upper wall 42., In this
`regard, it will be seen that substantially one-half of the
`abutment surface 42 and throug aperture 92 is formed in
`each of the housing halves or shell members 24, 26.
`Accordingly, the clip member 38 also extends over and
`generally rests upon the upper surface of abutment
`surface or wall 42, with the actuating end 40 thereof,
`upon initial assembly, extending outwardly of a through
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`aperture 94, provided therefor in the sidewall of the
`housing 22 (see FIG. 2).
`Referring now to FIGS. 8-12, a retractable bleeding
`‘ time lancet in accordance with a second embodiment of
`the invention is designated generally by the reference
`numeral 120. In many respects, the structure of the
`device of FIGS. 8-11 is similar to that previously de-
`scribed with reference to the embodiment shown in
`
`FIGS. 1-7. In this regard, the device 120 includes a
`housing 122 preferably formed of similar housing shells
`or halves 124, 126. Within the housing a blade 128 is
`mounted to a carrier means or member 130 which is in
`
`turn mounted for bi-directional sliding movement
`within the housing. The blade has a cutting edge 136,
`which in use is projected and retracted relative to a
`housing end opening 132.
`A retention and release means or mechanism for the
`
`carrier 130 may be generally of the same form described
`hereinabove with reference to elements 37, 38 of FIGS.
`1-7, and is not illustrated in FIGS. 8-12. That is, the
`carrier 130 may be provided with an upwardly project-
`ing release pin or member 137 which cooperates with a
`suitable clip or other means (not shown) in an upper
`portion of the housing in much the same fashion as
`illustrated and described above with reference to FIGS.
`1-7.
`
`In similar fashion to the embodiment of FIGS. 1-7,
`:;=. the device 120 includes a resilient biasing means in the
`. “e‘f"form of a similar coiled spring 34, which has a generally
`“helical body portion 50, here mounted over a receiving
`- {pin or post 151, and generally oppositely outwardly
`flfprojecting free ends or arms 152 and 154. The arm 152
`is engaged or in abutment with an abutment surface
`comprising a pin 142, which functions similarly to the
`surface 42 in the embodiment of FIGS. 1-7.
`The carrier 130 mounts the blade 128 by means of
`‘complementary receiving surfaces 180, 184 similar to
`=1:-i'those (80, 84) illustrated and described above with refer-
`nce to the embodiment of FIGS. 1-7.. Moreover, re-
`‘spective abutment surfaces or stop surfaces 146 of the
`housing 120, and 148 of the carrier 130, define the fully
`extended position of the carrier relative to the housing,
`for projecting the blade 128 outwardly thereof during
`use.
`
`35
`
`Departing from the embodiment of FIGS. 1-7, the
`driving force from the spring 134 is transmitted to the
`carrier 130 by means of a novel cam means or member
`200. The cam member 200 will be seento comprise a
`generally flat body portion 202 which is rotatably
`mounted to the housing 120 by a projecting shaft mem-
`ber or portion 204. In the illustrated embodiment, shaft
`204 is formed on the cam 200; however, other arrange-
`ments for achieving this rotational mounting may be
`utilized without departing from the invention. The cam
`200 further includes a first or driven projection or pin-
`like member or portion 206 which is engaged by the free
`end 154 of spring 134. A second, driving projection or
`pin-like member or portion 208 engages a first abutment
`surface 210 of the carrier. Projection 208 drives the
`carrier in a generally linear downward direction in
`response to the release of the spring and resulting force
`of the spring end 154 on projection 206, to achieve the
`first or initial portion of the compound movement of the
`carrier blade. This first or initial portion of compound
`movement is illustrated, for example, in FIG. 9, wherein
`the blade is shown in a fully extended position relative
`to the housing.
`
`60
`
`65
`
`4,735,203
`
`8
`In order to achieve the second portion of compound
`motion, comprising retraction of the blade to a position
`substantially as shown in FIG. 10, the cam means or
`member 200 includes a return projection 212. Upon
`rotation of the cam 200 to the position shown in FIG. 9,
`it will be seen that return projection 212 approaches
`engagement with a second or return abutment surface
`or projection 214, formed on the carrier 130. Thereaf-
`ter, as best viewed in FIG. 11, the continued rotation of
`the cam 200 causes engagement between surfaces or
`members 212 and 214, which results in slidable move-
`ment or lifting of the carrier 130 to retract the blade 128,
`and particularly the cutting edge 136 thereof, back
`within the housing 122. This retractive movement com-
`prises the second portion of the compound motion pre-
`viously described.
`Moreover, it will be seen that like the embodiment of
`FIGS. 1-7, the device embodied in FIGS. 8-12 is non-
`resettable and non-reusable, since the internal compo-
`nents, spring, etc. are inaccessible for resetting back to
`the initial position shown in FIG. 8. Moreover,
`the
`blade is retracted within the housing following use, so
`that the device carmot be used manually, that is, without
`the spring-loaded controlled force and timing thereof.
`In the embodiment illustrated in FIGS. 8-12, the driven
`pin or projection member or portion 206 is generally
`teardrop-shaped to achieve the desired motion of the
`cam in response to the unwinding or release of tension
`on spring 134. Additionally, as best viewed in FIG. 11,
`it will be seen that a drop-off 220 is provided at the
`extreme end of abutment surface 210 to assure disen-
`gagement thereof by the pin or driving member 208
`when it reaches the position illustrated in FIG. 10, so as
`to assure lifting of the carrier by the abutting of surfaces
`or members 212 and 214. Moreover, in order to provide
`clearance for the projection or return member or sur-
`face 212 during rotation of the cam 200, an additional
`relief area or cutaway portion 222 is also provided in
`the carrier 130.
`
`While particular embodiments of the invention have
`been shown and described in detail, it will be obvious to
`those skilled in the art that changes and modifications of
`the present invention,
`in its various aspects, may be
`made without departing from the invention in its
`broader aspects, some of which changes and modifica-
`tions being matters of routine engineering or design, and
`others being apparent only after study. As such, the
`scope of the invention should not be limited by the
`particular embodiment and specific construction de-
`scribed herein but should be defined by the appended
`claims and equivalents thereof. Accordingly, the aim of
`the appended claims is to cover all such changes and
`modifications as fall within the true spirit and scope of
`the invention.
`The invention is claimed as follows:
`1. A retractable, non-reusable bleeding-time lancet
`apparatus, comprising: a housing having an end open-
`ing; blade means; carrier means for fixedly mounting
`said blade means and mounted in said housing for slid-
`ing motion toward and away from said end opening;
`resilient biasing means comprising one and only one
`torsion spring mounted in said housing in a prestressed
`condition and operatively coupled for selectively and in
`sequence, urging said carrier means in opposite direc-
`tions for achieving said sliding motion in a compound
`motion comprising, in sequence, motion first toward
`and then away from said housing end opening as said
`resilient biasing means goes from said prestressed condi-
`
`ACTA EX. 1022-010
`
`ACTA Ex. 1022-010
`
`

`
`4,735,203
`
`9
`tion toward an unstressed condition; non-resettable
`release means for initially retaining said biasing means in
`said prestressed condition and selectively activatable
`once and only once for releasing said resilient biasing
`means to urge said carrier means in said compound for
`momentarily projecting and then rapidly retracting at
`least a cutting edge of said blade means through said
`end opening; cooperating means on said housing and
`said carrier means for defining respective limits of slid-
`ing motion of said carrier means corresponding to ex-
`tended and retracted positions of said blade means cut-
`ting edge relative to said housing end opening; and
`means operatively engaging said resilient biasing means
`with said carrier means for achieving said compound
`motion of said carrier means; said release means being
`operatively disengaged from said biasing means upon
`release thereof and incapable of re-engagement the