PCI‘
`
`International Bureau
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`
`
`
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
` (51) International Patent Classification 5 :
` (11) International Publication Number:
`WO 92/02175
`A613 5/00
`
`
`(43) International Publication Date:
`20 February 1992 (20.02.92)
`
`Published
`
` (22) International Filing Date:
`(21) International Application Number:
`PCT/US91/05616
`
`
`With international search report.
`
`7 August 1991 (07.08.91)
`
`Before the expiration of the time limit for amending the
`
`
`claims and to be republished in the event of the receipt of
`amendments.
`
`(30) Priority data:
`
`566,160
`10 August 1990 00.08.90)
`US
`
`732,109
`18 July 1991 (18.07.91)
`US
`
`
` (71x72) Applicant and Inventor: SWIERCZEK, Remi [US/US];
`
`6399 Lake Ledge Ct., Concord, OH 44077 (US).
`
`(74) Agents: WATKINS, Mark, A. et al.; 1225 West Market
`Street, Akron, OH 44313 (US).
`
`
`
`
`
`
`
`
`(81) Designated States: AT (European patent), AU, BE (Euro—
`pean patent), BR, CA, CH (European patent), DE (Euro-
`pean patent), DK (European patent), ES (European pa-
`tent), FR (European patent), GB (European patent), GR
`(European patent), IT (European patent), JP, KR, LU
`(European patent), NL (European patent), PL, SE (Euro-
`+ pean patent), SU.
`
`
`
`
`
`(54) Title: DISPOSABLE SKIN PERFORATOR AND BLOOD TESTING DEVICE
`
`
`
`, (57) Abstract
`
`A device (20) that pierces the skin due to the collapsing of dome (1) between the fingertips. Immediately after a
`puncture is made, a blood or exudate sample can be collected on an absorbent test strip (8) laminated on the presure plate.
`Flow enhancement of blood or exudate from the puncture site is achieved by maintenance of pressure around the site and
`on the imparting of a vacuum within the device. A shutter device (5) incorporated into the skin perforator prevents
`repeated use of the device.
`
`+ See back of page
`
`
`
`International Bureau
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`
`
`
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
` (51) International Patent Classification 5 :
` (11) International Publication Number:
`WO 92/02175
`A613 5/00
`
`
`(43) International Publication Date:
`20 February 1992 (20.02.92)
`
`Published
`
` (22) International Filing Date:
`(21) International Application Number:
`PCT/US91/05616
`
`
`With international search report.
`
`7 August 1991 (07.08.91)
`
`Before the expiration of the time limit for amending the
`
`
`claims and to be republished in the event of the receipt of
`amendments.
`
`(30) Priority data:
`
`566,160
`10 August 1990 00.08.90)
`US
`
`732,109
`18 July 1991 (18.07.91)
`US
`
`
` (71x72) Applicant and Inventor: SWIERCZEK, Remi [US/US];
`
`6399 Lake Ledge Ct., Concord, OH 44077 (US).
`
`(74) Agents: WATKINS, Mark, A. et al.; 1225 West Market
`Street, Akron, OH 44313 (US).
`
`
`
`
`
`
`
`
`(81) Designated States: AT (European patent), AU, BE (Euro—
`pean patent), BR, CA, CH (European patent), DE (Euro-
`pean patent), DK (European patent), ES (European pa-
`tent), FR (European patent), GB (European patent), GR
`(European patent), IT (European patent), JP, KR, LU
`(European patent), NL (European patent), PL, SE (Euro-
`+ pean patent), SU.
`
`
`
`
`
`(54) Title: DISPOSABLE SKIN PERFORATOR AND BLOOD TESTING DEVICE
`
`
`
`, (57) Abstract
`
`A device (20) that pierces the skin due to the collapsing of dome (1) between the fingertips. Immediately after a
`puncture is made, a blood or exudate sample can be collected on an absorbent test strip (8) laminated on the presure plate.
`Flow enhancement of blood or exudate from the puncture site is achieved by maintenance of pressure around the site and
`on the imparting of a vacuum within the device. A shutter device (5) incorporated into the skin perforator prevents
`repeated use of the device.
`
`+ See back of page
`
`
`
`t)
`
`+4};
`
`+ DESIGNATIONS DE “SU”
`
`0n ignore encore pour quels Etats de l’ancienne Union soviétique une désignation de l’Union
`soviétique déploie so: effets.
`
`UNIQUEMENTA TITRE D’INFOIM’IATYON
`
`Codes utilisés pour identifier les Etats parties au PCI‘, sur les pages de couverture des brochures
`publiant des demandes internationales en vertu du PCI'.
`
`Monaco
`
`AT
`AU
`BB
`BE
`BF
`36
`BJ
`BR
`CA
`CF
`CG
`CH
`Cl
`CM
`CS
`DE»
`DK
`
`Aulrichc
`Australia
`Barbuda
`Belgiquc
`Burkina Faso
`Bulgaria
`Bénin
`Brésil
`Canada
`Répuhliquc Ccnlraficainc
`Congo
`Suissc
`Célc d‘lvoirc
`Camcroun
`Tchécoslovaquic
`Allcmagnc
`Dancmark
`
`ES
`Fl
`FR
`GA
`GB
`GN
`GR
`HU
`IT
`JP
`KP
`
`KR
`Ll
`LK
`LU
`MC
`
`Espagnc
`Finlandc
`France
`Gabon
`Royaumc-Uni
`Guinéc
`Grécc
`Hongric
`Italic
`Japan
`République populairc démocraliquc
`dc Coréc
`Républiquc dc Coréu
`Licchlcnslcin
`Sri lanka
`Luxembourg
`
`Madagascar
`Mali
`Mongolia
`Mauritania
`Malawi
`PayyBau
`Norvégc
`Pologne
`Roumanie
`Soudan
`Suédc
`Sénégal
`Union soviéliquc
`Tchad
`Togo
`Elms-Unis d'Amériquc
`
`
`
`wo 92/02175
`
`PCT/US91/06616
`
`1
`
`DISPOSABLE SKIN PERFORATOR AND BLOOD TESTING DEVICE
`
`um
`
`This is a Continuation-in-part of application 07/566,160,
`
`which has been allowed and which was a Continuation-in—part of
`
`Application 07/328,907, filed March 27, 1989, now abandoned.
`
`W
`
`This invention, generally, relates to a device for
`
`drawing a small amount of blood from a person’s fingertip.
`
`More specifically,
`
`the invention relates to a device for
`
`obtaining a minute volume of blood and applying the same to a
`
`test medium for subsequent analysis. Another embodiment of
`
`the present invention relates to a single use device for
`
`obtaining a blood sample employing a means for preventing
`
`multiple use of the device.
`
`fiackground of the Invention
`
`Blood testing is a common practice.
`
`The samples can be
`
`derived by merely pricking the fingertip with a sharp tool.
`
`Then,
`
`the samples must be exposed to proper test medium to
`
`acquire the test result.
`
`In the past, a complex, sudden release, pen type device
`
`with disposable blades was used to perforate the skin
`
`painlessly. Once the skin was cut, separate test medium was
`
`introduced to the blood sample.
`
`
`
`wo 92/02175
`
`Pcr/Us91/05616
`
`2
`
`Summary of the Invention
`
`‘1
`
`In accordance with the embodiments of the present
`
`invention, this device is a disposable skin perforator for
`
`obtaining a sample of blood by puncturing the skin.
`
`A further
`
`embodiment discloses a test medium attached to a pressure
`
`plate on the device which can absorb blood flowing from the
`
`puncture.
`
`Therefore, one objective of my invention is to provide a
`
`simple, painless and inexpensive fingertip perforator that
`
`draWS a sample of blood for testing and self-analysis.
`
`Another objective of my invention is to provide a
`
`convenient holding means for litmus paper and other type test
`
`medium in such a way to allow for saturation of the test
`
`medium With blood while it is drawn.
`
`A third objective of my invention is to provide a package
`
`that consists of a chart and bandage.
`
`The chart can be color
`
`coded to read the test results while the bandage can be used
`
`to protect the cut finger.
`
`A further object of my invention is to provide a skin
`
`perforator for obtaining a blood sample which possesses a
`
`self-contained means for cleansing and/or disinfecting the
`
`puncture site, prior to perforation of the skin.
`
`Still a further object of my invention is to provide a
`
`skin perforator for obtaining a blood sample which employs a
`
`means for preventing multiple use of the same device.
`
`other
`
`
`
`wo 92/02175
`
`PCI/US91/05616
`
`3
`
`objectives of my invention will become clear with reference to
`
`the accompanying figures.
`
`Brief Description of the Drawings
`
`Figure 1 is a plan view of the perforator device.
`
`Figure 2 is a cross-sectional View taken on line 2—2 of
`
`Figure 1.
`
`Figure 3 is a cross—sectional view similar to Figure 2
`
`further illustrating a sealing means and a step formed on the
`
`surface of pressure plate.
`
`Figure 4 is a cutaway cross-sectional view illustrating
`
`the dome in a depressed position and a step causing the
`
`formation of a means for air exchange.
`
`Figure 5 is a cross-sectional view of an alternative
`
`embodiment of a skin perforator according to my invention
`
`illustrating a dome its uncollapsed position.
`
`Figure 6 is a cross-sectional view of the skin perforator
`
`shown in Figure 5 and illustrating the dome in its collapsed
`
`position.
`
`Figure 7 is an bottom elevational view of an alternative
`
`embodiment of a skin perforator according to my present
`
`invention illustrating a self—contained means for cleaning
`
`and/or disinfecting the puncture site.
`
`Figure 8 is a cross-sectional view of skin perforator
`
`according to my present invention and illustrating a removable
`
`
`
`W0 92/02175
`
`PCT/US91/0&616
`
`4
`
`guard incorporated therein for maintaining the sterility of
`
`barb until use.
`
`Figure 9 is a top elevational view of a skin perforator
`
`according to my present invention illustrating a shutter means
`
`for preventing multiple use,
`
`in its tensioned state.
`
`Figure 10 is a cross—sectional view of the skin
`
`perforator in figure 9,
`
`taken across line 10—10.
`
`Figure 11 is a top elevational view of the skin
`
`perforator shown in figures 9 and 10,
`
`illustrating the shutter
`
`means in its untensioned state.
`
`Figure 12 is a cross—sectional view of the skin
`
`perforator shown in figure 11,
`
`taken along line 12-12.
`
`Figure 13 is a top elevational view of a skin perforator
`
`according to my present invention illustrating an alternative
`
`shutter means for preventing multiple use in its tensioned
`
`state.
`
`Figure 14 is a cross-sectional view of the skin
`
`perforator shown in figure 13 taken along line 14—14.
`
`Figure 15 is a top elevational view of the skin
`
`perforator shown in figures 13 and 14 and illustrating the
`
`shutter means in its untensioned state.
`
`Figure 16 is a cross-sectional view of the skin
`
`perforator as shown in figure is taken along line 16-16.
`
`Figure 17 is a top elevational view of a convex dome for
`
`a skin perforator according to my present invention having a
`
`integrally formed shutter means.
`
`
`
`wo 92/02175
`
`PCT/US91/os'616
`
`5
`
`Detailed Description of the Preferred Embodiment
`
`Now with reference to the invention illustrated in the
`
`drawings, and looking particularly at figure 1, this figure
`
`shows a top plan view of the perforator device 20. Perforator
`
`device 20 comprises generally a cover plate 21 and a pressure
`
`plate 3 of essentially similar size and shape positioned
`
`adjacent to one another and attached by a plurality of welds 4
`
`and/or crimps 6.
`
`Cover plate 21 has a spherical shaped dome 1 formed
`
`therein so as to define a convex surface with respect to said
`
`cover plate 21 and directed outward and away from said
`
`pressure plate 3. Cover plate 21 with spherical dome 1 formed
`
`integrally therein is made of a resilient plastic or thin
`
`metal material having a substantial memory so that as dome 1
`
`is deflected inward by a force it will return to essentially
`
`its original shape upon the removal of said force.
`
`Pressure plate 3 is to have a rigid structure as compared
`
`to dome 1 and may be made from any plastic or metal material
`
`capable of maintaining such rigidity. Welds 4 or crimps 6 of
`
`varying number and size are contemplated. Pressure plate 3
`
`has an aperture 7 formed generally in the center of said
`
`pressure plate 3 and having sufficient diameter to allow the
`
`passage of a barb 2 through the aperture 7. Shelf 23 defines
`
`the periphery of said aperture 7.
`
`A barb 2 is formed in a portion of dome 1 utilizing
`
`stamping methods which are well known in the art. Barb 2
`
`remains integral with dome 1 along edge 24 of barb 2. Barb 2
`
`
`
`W0 92/02175
`
`PCT/US91/0é616
`
`6
`
`is disclosed as being essentially triangular in shape however,
`
`any shape which yields a point capable of piercing the human
`
`skin is contemplated.
`
`The stamping of dome l to form barb 2
`
`results in an aperture having essentially the same dimensions
`
`as said barb 2. Barb 2 is formed so as to be directed inward
`
`and toward the aperture 7 of plate 3. After stamping, barb 2
`
`can be coined or shaved to yield sharp yet smooth edges, by
`
`any means which are well known in the art. Alternatively,
`
`such edges of barb 2 can be achieved by grinding the same, but
`
`grinding currently appears not to be a cost effective method
`
`as related to this application.
`
`Dome 1 serves as a stress accumulating means wherein said
`
`dome 1 offers increasing resistance to applied pressure,
`
`directed inward, until said dome is deformed to an extent that
`
`it begins to undergo an inversion. At this point, resistance
`
`to the applied pressure decreases rapidly such that the
`
`central region of dome 1 containing the barb is accelerated
`
`inward and toward aperture 7 of pressure plate 3. With
`
`continued pressure dome l is inverted, directing barb 2
`
`through aperture 7 and into the adjacent skin,
`
`thereby
`
`creating a puncture site.
`
`An alternative embodiment is contemplated wherein said
`
`cover plate 21 and said pressure plate 3 are made from a
`
`single piece of material. Cover plate 21 and pressure plate 3
`
`are folded against each other so as to share a common edge,
`
`the outer edges of each plate being secured to one another
`
`utilizing welds 4 or crimps 6 as discussed previously herein.
`
`
`
`wo 92/02175
`
`Per/US91/05616
`
`7
`
`In its inverted state, dome 1 assumes an essentially
`
`cantilever configuration which accumulates a force opposing
`
`the inversion and aids in the resilient return the dome 1 to
`
`its convex configuration.
`
`Figures 5 and 6 disclose an alternative embodiment 30 of
`
`the skin perforator.
`
`The pressure plate 33 is preferably made
`
`from a molded plastic material and is essentially annular in
`
`shape.
`
`A convex dome 31, similar to dome 1 of figure 1 and
`
`having a point penetrating barb 32,
`
`is seated on a step 38 and
`
`inside of an outer rim 35 in pressure plate 33. Pressure
`
`plate 33 contains an aperture 37 in its center which allows
`
`passage of barb 32 therethrough. Shelf 34 serves to stop the
`
`inversion of dome 31,
`
`thereby controlling the depth of barb 32
`
`into the patient’s skin.
`
`In order to achieve a quick and relatively painless
`
`penetration of the skin, distance D between the peak of dome
`
`31,
`
`in its undepressed state, and shelf 34 of pressure plate
`
`33 is preferably at least about
`
`.10 inches. While this
`
`distance is not absolute, it has been calculated to account
`
`for a minimum stroke depth, deflection waste and differences
`
`in patient skin texture. According to the present
`
`embodiments,
`
`the minimum depth stroke is identified as that
`
`distance necessary for the dome to undergo its inversion and
`
`is estimated at .050 inches.
`
`The deflection waste refers to
`
`the movement of the dome 31 toward the puncture site upon the
`
`application of force but prior to the dome's inversion and is
`
`calculated at about
`
`.025 inches. Approximately .030 inches is
`
`
`
`wo 92/02175
`
`PCT/US91/0é616
`
`8
`
`necessary to account for differences in the thickness and
`
`texture of the skin at the puncture site.
`
`A distance D
`
`ranging from about 0.075 inches to about 1.025 inches insures
`
`penetration of the skin coupled with a positive return of the
`
`inverted dome to its convex configuration.
`
`The present device 20 is designed to perforate the skin
`
`on the finger of the patient.
`
`The finger should be prepared
`
`so as to cleanse and remove as many contaminates from the
`
`perforation site as is possible using techniques which are
`
`well known in the art.
`
`Optionally, any of the embodiments disclosed herein are
`
`contemplated as capable of incorporating a self-contained
`
`cleaning means disclosed in figure 7. Device 30 is shown as
`
`incorporating an absorbent pad,
`
`impregnated with a cleansing
`
`and/or disinfecting agent, affixed to the lower surface 39 of
`
`pressure plate 33, adjacent the patient’s skin.
`
`The absorbent pad 40 is intended to be made from any
`
`cotton, synthetic or other fiber commonly used in the art for
`
`such purpose and capable of retaining liquid therein.
`
`The
`
`cleansing or disinfecting agents can be selected from any such
`
`agents known in the art,
`
`including but certainly not limited
`
`to ethyl alcohol,
`
`isopropyl alcohol or benzalkonium chloride.
`
`The lower surface 39 of pressure plate 33 is aseptically
`
`covered or sealed to keep the surface free from contaminates
`
`and to prevent evaporation of the cleansing agent.
`
`Immediately prior to use, a packaging seal is removed thus
`
`exposing the device and/or lower surface 39.
`
`The eventual
`
`
`
`WO 92/02175
`
`PCP/US91/05616
`
`9
`
`puncture site can then be cleansed or disinfected by rubbing
`
`lower surface 39 of device 30 over the site. Often times,
`
`the
`
`puncture site is a fingertip, at which time the device is
`
`simply rubbed between the thumb and fingertip.
`
`In this
`
`manner,
`
`the eventual puncture site is cleansed and prepared to
`
`receive the point penetrating barb.
`
`Figure 8 reveals a means for preserving the sterility of
`
`barb 32 until just prior to the time of desired use. This
`
`packing means is disclosed as a tab 42 having a base portion
`
`43 and a stem 44.
`
`The stem 44 is formed with a cavity 45 open
`
`at the end opposite base 43. Cavity 45 has a depth at least
`
`equal to the length of barb 32 in dome 31. Cavity 45 is
`
`capable of receiving a wax or other medium exhibiting
`
`properties of a solid at or above room temperature but
`
`liquefying in the presence of heat. Additionally, such medium
`
`must possess the ability to prevent or resist the growth of
`
`bacteria,
`
`fungi and other microbes, either inherently or by
`
`the addition of antimicrobials.
`
`Following the sterilization of barb 32 after assembly,
`
`cavity 45 in stem 44 is filled with a medium 46 in a liquid or
`
`semi-solid state.
`
`Immediately thereafter, barb 32 is inserted
`
`into the medium contained in cavity 45. Thereupon cooling, a
`
`frangible connection between tab 42 and barb 32 is formed.
`
`Tab 42 is removed prior to use of the skin perforator by
`
`pliably moving tab 42 relative to device 30. other means of
`
`frangibly connecting tab 42 about barb 32 as are known in the
`
`
`
`W0 92/02175
`
`PCT/US91/05-616
`
`10
`
`art to accomplish the same or similar purpose, are
`
`contemplated, such as ultrasonic welding and the like.
`
`Turning again to Figs. 1-3 but having applicability to
`
`all embodiments,
`
`the device 20 is operated by positioning
`
`said device 20 against the patient’s finger to be punctured so
`
`that the intended puncture site of the finger comes within a
`
`area defined by the outer circumference of aperture 7 in
`
`pressure plate 3. Pressure is then applied to the dome by the
`
`patient or person assisting the same.
`
`The initial applied
`
`pressure causes pressure plate 3 to be pressed against the
`
`skin of the patient further isolating the intended puncture
`
`site. As additional pressure is applied to dome 1 the stress
`
`accumulation in the dome will result in the sudden inward
`
`collapsing of dome 1, directing barb 2 through aperture 7,
`
`thereby causing a piercing of the patient's skin. This inward
`
`movement of barb 2 is stopped as the inner surface of dome l
`
`strikes shelf 23 of pressure plate 3 to provide a predictable
`
`puncture depth.
`
`As the applied pressure on dome 1 and pressure plate 3 is
`
`removed or reduced,
`
`the collapsed dome will resiliently return
`
`to its original shape and accordingly withdraw barb 2 from the
`
`patient's finger.
`
`The maintenance of a small amount of
`
`pressure against pressure plate 3, but pressure insufficient
`
`to cause collapse of dome 1, will create a tension to the area
`
`around the puncture site, resulting in an enhanced and
`
`continuous blood flow from the puncture site. This applied
`
`tension has a two—fold effect with respect to enhanced blood
`
`
`
`wo 92/02175
`
`Per/US91/05616
`
`11
`
`flow. First, this tension maintains the skin in a stretched
`
`posture which holds edges of the puncture site apart.
`
`Second,
`
`the pressure applied to the region surrounding the puncture
`
`site forces blood out of this tissue and into adjacent tissue
`
`which may be outside or inside of this ring of applied
`
`pressure.
`
`The blood directed inward seeks relief from this
`
`pressure and as a result exits through the puncture site.
`
`Flow enhancement of the blood from the puncture site is also
`
`increased by the creation of a partial vacuum or pressure
`
`differential within the confined area defined by dome 1,
`
`pressure plate 3 and the patient's finger. This area as
`
`defined while the dome is in the collapsed position, has a
`
`comparatively reduced volume compared to the same area with
`
`dome 1 in its original position. While in the depressed
`
`position,
`
`the person administrating the applied force may
`
`simply cover or obstruct aperture 10 formed from the stamping
`
`of barb 2, as the pressure is withdrawn. This sudden increase
`
`in volume in the area enclosed by the pressure plate 3
`
`and
`
`dome 1 creates a vacuum at the aperture 7.
`
`The vacuum causing
`
`free flow of blood from the puncture site.
`
`After the barb has been withdrawn from the finger,
`
`the
`
`disposable skin perforator can be removed and a blood sample
`
`collected as in prior art devices by squeezing the finger, if
`
`necessary.
`
`To further effect a vacuum in the confined area of
`
`perforator device 20, a seal or gasket 25 can be placed
`
`between the cover plate 21 and the pressure plate 3 as is
`
`
`
`wo 92/02175
`
`'
`
`PCI/US91/0é616
`
`12
`
`shown in Fig. 3. This seal or gasket 25 can be made from a
`
`variety of flexible plastic or rubber materials as is well
`
`known in the art and serves to prevent air passage into and
`
`out of the confined area of perforator device 20 through the
`
`contact between the peripheral edges of cover plate 21 and
`peripheral plate 3.
`A preferred manner of creating a seal or
`
`gasket 25 is to apply a laminate to the inner surface of
`
`either the cover plate 21 or the pressure plate 3.
`
`Such
`
`laminate becomes sandwiched between cover plate 21 and
`
`pressure plate 3 during the application of welds 4 or crimps
`
`6.
`
`Still another embodiment which is contemplated to create
`
`a vacuum for improving flow enhancement is a formation of one
`
`or more steps 26 in pressure plate 3. These steps 26 are
`
`essentially projections of varying width formed on the inner
`
`surface of pressure plate 3 or cover plate 21 along its
`
`periphery and located between the crimper 6 or welds 4. Steps
`
`26 are of sufficient size so as to extend into the area
`
`defined by and below the dome 1. Steps 26 do not interfere
`
`with the depression of the dome but contact the opposing
`
`surface after substantial depression of the dome. As dome 1
`
`is depressed to effectuate a puncture, steps 26 cause
`
`sufficient deflection along the periphery of cover plate 21 to
`
`form a temporary break in the seal betWeen cover plate 21 and
`
`pressure plate 3 as shown in Fig.4.
`
`This break allows for
`
`the exit of air trapped within the confined area of the
`
`perforator device 20.
`
`Following puncture of the finger by
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`
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`l3
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`barb 2, and the gradual withdrawal of the applied pressure
`
`from dome 1, the seal 25 is reformed thereby creating the
`
`vacuum to enhance blood flow from the puncture site.
`
`The present invention,
`
`in a further preferred embodiment,
`
`comprises an absorbent test strip 8 and is best illustrated in
`
`the cross-sectional views of Figs 2 and 3. Test strip 8 is
`
`disclosed as generally a pad or sheet of material capable of
`
`absorbing blood or exudate from the puncture site created by
`
`barb 2.
`
`The test strip 8 is contemplated as being treated or
`
`coated with various reagents which react with the blood or
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`exudate to cause color or chemical changes which then can be
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`quantitatively or qualitatively compared to a known standard.
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`Most home use test strips utilize color change techniques and
`
`yield fairly quick results which can be interpreted by
`
`comparing the test strip to a color coded chart provided with
`
`the device.
`
`The most common test strip contemplated is that
`
`used for the determination of the patient’s blood sugar level.
`
`The technology of such test strips is well known in the art.
`
`Test strip 8 is disclosed as being laminated to the outer
`
`surface of pressure plate 3. Lamination may be done using
`
`known adhesives or by means of crimps 6. Test strip 8 may be
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`of varying shapes or sizes but preferably has a length
`
`slightly greater than the diameter of aperture 7. Although,
`
`not required, test strip 8 contains a aperture dimensioned
`
`and positioned to allow passage of barb 2 therethrough.
`
`In
`
`this embodiment the device is used similar to that as
`
`described previously herein. However, test strip 8 is
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`14
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`positioned immediately adjacent to the patient’s finger with
`
`the aperture 9 in the test strip 8 identifying the intended
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`test site.
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`Following the puncture of the patient's finger by barb 2,
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`the disposable skin perforator 20 remains in contact with the
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`finger to allow the blood or exudate from the puncture site to
`
`be absorbed onto test strip 8. Maintenance of a pressure
`
`pressing pressure plate 3 against the finger, but which is
`
`insufficient to cause collapse of dome 1, will enhance blood
`
`flow as previously described and allow for saturation of test
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`strip 8 with the blood or exudate from the puncture site.
`
`This device,
`
`incorporating test strip 8 places the test
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`medium immediately adjacent to the puncture site and allows
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`blood collection and testing to begin immediately upon
`
`puncture. Furthermore, test strips 8 representing various
`
`thickness may be used.
`
`Such strips 8 can extend into the
`
`recession found in the bottom surface of pressure plate 3 by
`
`shelf 23.
`
`In a less preferred, but contemplated embodiment,
`
`test strip 8 would omit the formation of aperture 9 therein.
`
`Barb 2 is of sufficient length and sharpness to cut test strip
`
`8 simultaneously with the skin of the fingertip. However, it
`
`is thought that such a practice may permit the introduction of
`
`fibrous material from test strip 8 into the puncture site
`
`formed by barb 2.
`
`The skin perforators of the present invention are
`
`intended as disposable or single use devices, unless the
`
`devices are resterilized after each use by means known in the
`
`
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`15
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`art.
`
`In this way,
`
`the risk of patient contamination resulting
`
`from the use of unsterile or tainted devices is minimized.
`
`In
`
`furtherance of this objective, the skin perforator shown in
`
`figures 8—17 incorporate a shutter means for preventing
`
`repeated use of the device.
`
`Generally,
`
`the device is fully functional upon its
`
`removal from the aseptic packaging.
`
`The device is used to
`
`perforate the skin of a patent for the purposes of obtaining a
`
`blood sample by placing the pressure plate in contact with the
`
`skin and applying force to the convex dome as previously
`
`described.
`
`In these embodiments,
`
`the force applied to cause
`
`inversion of the dome resulting in the puncture of dome by
`
`barb 32 is also utilized to fracture or otherwise disable a
`
`stop member functioning to hold a shutter device in its
`
`tensioned position. Upon retraction of the dome,
`
`the shutter
`
`means will advance to its untensioned position between barb 32
`
`and aperture 37.
`
`In this way, subsequent attempts to utilize
`
`device 30 as a skin perforator will force barb 32 against the
`
`shutter, preventing puncture of the patient’s skin. Once the
`
`shutter means has advanced to its untensioned position between
`
`barb 32 and aperture 37,
`
`the device is disabled and to be
`
`discarded.
`
`Specifically, figures 8-11 illustrate one embodiment of a
`
`shutter means for preventing repeated use of a skin
`
`perforator. Figures 8 and 9 disclose the shutter means
`
`generally 50, having a shield portion 52 and a stem portion
`
`54.
`
`The stem 54 is contemplated as an essentially rigid
`
`
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`wo 92/02175
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`”fl
`
`16
`
`material having a substantially long term memory so as to
`
`return to its original untensioned position even after
`
`extended periods of time in a tensioned state.
`
`Such suitable
`
`materials include but are not limited to various types of
`
`plastics or aluminum.
`
`The proximal end of stem 54 is shown
`
`as attached to an inner wall of the pressure plate 33 although
`
`it is to be recognized that alternative sites of attachment
`
`are possible.
`
`A shield member 52 is secured to the distal end of stem
`
`54.
`
`The shield member 52 is intended as having a total area
`
`approximately equal or grater to aperture 37.
`
`Stop member 56 is located between aperture 37 and shutter
`
`means 50 and serves to maintain the shutter means 50 in a
`
`tensioned position until completion of the device’s initial
`
`use.
`
`Step member 56 is intended to be constructed with
`
`sufficient strength to enable it to hold shutter means 50 in a
`
`tensioned position but capable of fracturing, deforming,
`
`pivoting or otherwise yielding to the force of the skin
`
`perforator’s activating mechanism,
`
`in this case the dome,
`
`in
`
`order to release the shutter means thereby preventing further
`
`use of this particular device.
`
`Stop member 56 is contemplated as being made from
`
`material similar to pressure plate 33 and formed integrally
`
`therewith.
`
`A frangible connection or weakened portion 58 is
`
`formed therein but possessing sufficient strength to withstand
`
`the pressure of a tensioned shutter means 50. Upon
`
`compression of dome 31 from.applied force,
`
`the frangible
`
`
`
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`PCT/US91/05616
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`l7
`
`connection 58 is broken as the barb penetrates the skin. Upon
`
`retraction of dome 31 to its original position, shutter means
`
`50 advances to its untensioned position as illustrated in
`
`figures 11 and 12 with shield 52 covering aperture 37.
`
`In
`
`this way, subsequent attempts to utilize device 30 will result
`
`in the barb’s contact with shield 52 thereby preventing
`
`additional punctures of the skin using the same device.
`
`Figures 13-16 illustrate an alternative shutter means 60
`
`utilizing the same general principles previously discussed.
`
`Shutter stem 64 is secured to an inner wall of pressure plate
`
`33 by any means known in the art and is formed from any
`
`corrugated material capable of returning to an elongated
`
`position following compression.
`
`Stop member 66 is disclosed
`
`as a raised projection originating from surface 34 and formed
`
`integrally therefrom.
`
`Stop member 66 is compressed into a
`
`vwid or weakened region of pressure plate 33 by the force of
`
`the dome 31 as it directs the barb 32 into the skin.
`
`The shuttle means as illustrated in the embodiments
`
`previously disclosed herein need only possess sufficient
`
`tension to enable it to position itself between the barb and
`
`the aperture. Preferably the tension applied to the shutter
`
`means is not so great as to cause contact with the barb, while
`
`in the patients skin. Alternatively, a retaining means 68 as
`
`shown in Fig. 14 may be formed in or on dome 31 to delay the
`
`advance of the shutter means to its untensioned position until
`
`after the barb is withdrawn from the puncture site.
`
`
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`wo 92/02175
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`18
`
`Figure 17 shows a dome 31 and shutter means 70 formed as
`
`a single unit from resilient metal or plastic materials. One
`
`such embodiment is contemplated as being formed from the
`
`(Lu
`
`"J
`
`stamping of a resilient metal material as described previously
`
`with respect to dome 1.
`
`Shutter means 70 is folded towards the interior of dome
`
`31 along line 75. During assembly, stem 74 is compressed in
`
`order that shutter 70 is retained in a tensioned state until
`
`actuated by a stop member.
`
`The shutter means detailed in the
`
`drawings and specification of this application are
`
`illustrative and not to be construed as limited to the
`
`specific embodiments set forth herein.
`
`It is contemplated
`
`that the self-contained cleansing means and the shutter means
`
`have application well beyond the scope of the specific
`
`embodiments of skin perforators disclosed in this application.
`
`Hence the foregoing embodiments are designed to be simple
`
`in construction, economical to manufacture and capable of
`
`being packaged under sterile conditions.
`
`The various
`
`embodiments of the present invention are contemplated as being
`
`either disposable or reusable following sterilization using
`
`known techniques. While in accordance with the patent
`
`statutes the best mode and preferred embodiment of the
`
`invention have been described, it is to be understood that the
`
`invention is not limited thereto, but is rather to be measured
`
`by the scope and the spirit of the appended claims.
`
`
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`wo 92/02175
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`PCT/US91/05616
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`19
`
`EEAE_1§_QLA1MEQ_l§=
`
`l.
`
`A skin perforator for obtaining a sample of blood by
`
`puncturing the skin comprising:
`
`a)
`
`a pressure plate containing an aperture formed
`
`therein wherein said pressure plate is placed adjacent to and
`
`surrounding the area of skin to be punctured;
`
`b)
`
`a cover plate having a resilient convex panel
`
`formed
`
`therein, said cover plate being attached to said
`
`pressure plate and said convex panel having a point
`
`penetrating barb formed integrally therefrom and directed
`
`inward toward said aperture in said pressure plate wherein a
`
`pressure applied to the convex panel and directed toward said
`
`pressure plate overcomes the resistance of said convex panel
`
`and said convex panel undergoes at least a partial inversion
`
`to cause said barb to suddenly and rapidly penetrate the skin
`
`causing a puncture, said convex panel having a memory so as to
`
`resiliently return to its original convex shape upon removal
`
`of said pressure thereby withdrawing the barb from the skin,
`and
`
`c)
`
`a means for limiting said barb to a single
`
`penetration of the skin.
`
`2.
`
`The skin perforator as recited in claim 1 wherein
`
`said limiting means occludes the aperture of said pressure
`
`plate following the initial penetration.
`
`
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`PCT/US91/0ésm
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`20
`
`3.
`
`The skin perforator as recited in claim 1 wherein
`
`W
`
`said limiting means is activated by the inversion of said
`
`convex panel.
`
`4.
`
`The skin perforator as recited in claim 1 wherein
`
`said limiting means comprises a shutter having a shield
`
`portion and a stem portion, said shutter portion being
`
`dimensioned approximately equal to or greater than the
`
`aperture in said pressure plate, said stem portion capable of
`
`accepting applied tension and having a memory so as to advance
`
`predictably upon removal of said tension.
`
`5.
`
`The disposable skin perforator as recited in claim 1
`
`wherein said limiting means further comprises a stop member
`
`for retaining said shutter in a tensioned position.
`
`6.
`
`The skin perforator as recited in claim 5 wherein
`
`said stop member has a means for failing, said stop member
`
`having sufficient strength to retain said shutter in a
`
`tensioned position but yielding to a force applied during the
`
`inversion of said convex panel at said failing means to
`
`release the tension applied to said shutter.
`
`7. The skin perforator as recited in claim 1 further
`
`comprising an absorbent test strip attached to said pressure
`
`plate to absorb blood or exudate flowing from a puncture site
`
`formed by the penetrati
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