CA2089039A1 - Disposable skin perforator and blood testing device - Google Patents
Disposable skin perforator and blood testing deviceInfo
- Publication number
- CA2089039A1 CA2089039A1 CA002089039A CA2089039A CA2089039A1 CA 2089039 A1 CA2089039 A1 CA 2089039A1 CA 002089039 A CA002089039 A CA 002089039A CA 2089039 A CA2089039 A CA 2089039A CA 2089039 A1 CA2089039 A1 CA 2089039A1
- Authority
- CA
- Canada
- Prior art keywords
- skin
- perforator
- pressure plate
- recited
- barb
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15142—Devices intended for single use, i.e. disposable
- A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150358—Strips for collecting blood, e.g. absorbent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150435—Specific design of proximal end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150885—Preventing re-use
- A61B5/150916—Preventing re-use by blocking components, e.g. piston, driving device or fluid passageway
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
Abstract
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 pressure 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.
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 pressure 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.
Description
2~g~9 D:rSPOSAB~æ S~IN PJ~:RFC7R~ R ~D ~LO~D gl!l35!1~:1~G Dh~I~g ~echnical~Fi~ld This invention, generally, relates to a device for drawing a small am~unt o~ blood from a person's fingertipO
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 embsdiment of the present invention relates to a single u~e device ~or obtaining a blood sample employing a means for preventing multiple use of the device.
~ackgro~nd of the In~e~iQ~
Blood te3ting is a common practice,. The samples can be derived by merely pricking the fingertip with a sharp tool.
Then, the ~ample~ mu~t be ~xposed to proper test medium to ac~uire the test resultO
In the pa~t, a complex, sudden release, pen type device with dispo~able blades was uaed to perforate the 3kin painlessly. Once the ~kin was cut, separate test medium was introduced to the blood ~ample.
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~mmary Q the_lnYe~ti~n In accordance with the embodiments of the present invention, thi~ device i5 a di~posable skin perforator for obtaining a sample of blood by puncturing the skin. A further embodiment di~clo~s a test medium attached to a pres~ure pl~te on the device which can absorb blood flowing from the puncture.
Therefore~ one objective of my invention is to provide a simple, painless and inexpPnsive fingertip perforator that draw~ a sample of blood for testing and self-analy~
Another objective of my invention i~ to provide a convenient holding mean~ for litmus paper and other type test medium in such a way to allow for s~tu~eation of the te~t medium with blood while it i~ drawn.
A third objective of my invention is to provide a package that consists o~ a chart and bandage~ The chart can be color coded to read the test re3ult~ while the bandage can be used to protect the cut fin~er.
A further object of my invention is t~ provide a skin per~orator for obtaining a blood sample which pos~esses a ~elf-contained mean~ for clean~ing and/or di~infecting the puncture 3ite, prior o perforation of the skin.
S~ill a further object o~ my invention i~ to pro~ide a ~kin perfora~or ~or obtaining a blood sample whi~h employ~ a mean~ for preventing multiple use of the ~ame device. Other '"
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objective~ of my invention will become clear with reference to the accompanying figure~.
~xief Descri~tion ~f ~he D~m ~a Figure 1 i~ a plan view o~ the perforator device.
Figure 2 i3 a cro~-sectional view taken on line 2-2 of Figure 1.
Figure 3 i~ a cross-sectional view 3imilar to Figure 2 further illustrating a sealing mean~ and a step formed on the 3urface of preR~ure plate.
Figure 4 i~ a cutaway cros~-~ectional view illustrating the dome in a depressed position and a step causing the formation of a ~eans for air exchange.
Figure 5 i~ a cros~-sectional view o~ an alternative embodiment of a skin perforator according to my invention illu~xating a dome its uncollapsed position.
~ igure 6 i~ a cross-sectional view of the ~kin perforator sh~wn in Figure 5 and illustrating the dome in it~ collap~ed po~ition~
Figure 7 i~ an ~ot~om eleva~ional view of an alternative embodiment of a 3kin perforator according to my pre3ent invention illu~trating a s~lf-contained means for cleaning and/or di~infectillg the puncture ~ite.
Figure 8 18 ~ cross-~ectional view of ~kin perfor~tor according to my pre~ent invention and illu~trating a removable .
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~8~9 guard incorporated therein for maintaining the sterility o~
barb untll u~e.
Figure 9 ~s a top elevational view of a kin perforator according to my present invention illustra~ing a ~hutter mean~
for preventing multiple u~e, in it~ ten~ioned ~tateO
Figure 10 i8 a cross-~ectional view of the ski~
perforator in figure 9, taken acros~ line 10-10.
Figure 11 is a top elevational view of the ~kin perforator shown in figures 9 and 10, illu~trating the shutter means in its untensioned state, Figure 12 i~ a cross sectional view of the skin perforator shown in figu.re 11, taken along line 12-12.
Figure 13 i~ a top elevational view of a skin perforator according to my present invention illu~trating an alternative shutter means for preventing multiple u~3e in it~ ten~ioned 3tateO
Figure 14 is a cro~s-sectional view of the ~kin perforator ~hown in figure 13 taken along line 14-14.
Figure lS i~ a top elevational view of the skin perforator shown in figure~ 13 and 14 and illu~trating the ~hutter means in it~ unten~ioned ~tate.
~ igure 16 i~ a cro~ ectio~al view of the ~Xin per~orator a~ ~hown in figure 15 taken along line 16-16.
Figure 17 i~ a top elevational view of a convex dome for a skin perforator according to my present inve~tion having inteqrally ~ormed shu~ter ~ean~.
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De~ailed Dç~cri~ n of ~h8 Preferred ~mb~im~~
~ ow with reference to the invention illu~trated in the drawings, and looking particularly at figure 1, this figure ~hows a top plan view of the perforator device 20. Perforator devi~e 20 comprise~ generally a cover plate 21 and a pre~sure plate 3 of essentially similar ~ize and ~hapè po~itioned adjacent to one another and attached by a plurality of weld~ 4 and/or crimps 6.
Cover plate 21 has a spherical ~haped dome 1 formed therein so as to define a convex surface with re~pect to ~aid c3ver plate 21 and directed outward and away from said pre~eure plate 3. Cover plate 21 with ~pherical dome 1 formed integrally therein i~ made of a resilient plastic or thin metal material having a ~ubstan~ial memory ~o tha~ a~ dome 1 is deflected inward by a force it will return to essentially it~ original shape upon the removal of ~aid force.
Pressure plate 3 i8 to have a rigid ~tructure as compared to dome 1 and may b~ made from any plastic or ~etal material capable of maintaining such rigidity. Welds 4 or crImps 6 of varying number and ~ize are contemplated~ Pressure plate 3 has an aperture 7 formed generally in the ~enter of said pre~3ure pla~e 3 and having 3ufPicient diameter to allow the passage of a barb 2 through the aperture 7. Shelf 23 define3 the periphery of ~aid aperture 7.
A b~rb 2 i~ formed in ~ portion of dome 1 utilizing ~tamping method~ which are well known in the axt. Barb 2 remains integral with dome 1 alonq edg~ 24 of barb 2. Barb 2 :
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20~39 iY disclosed as being es~entially triangular in ~hape however, any ~hape which yield~ a point capable of piercing the human 8ki~ i8 contemplated. The ~tamping of dome 1 to form barb 2 re~ults in an aperture having e~entially the ~ame dimen~ion~
a~ said barb 2. Barb 2 i~ formed ~o a~ ko be directed inward and toward the aperture 7 of plate 3. After Btamping~ 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 edge~ of barb 2 can be a~hieved by grinding the ~ame, but grinding currently appears not to be a co~t effective method as related to this application.
Dome 1 serve~ as a ~tres~ accumulating mean~ wherein ~aid dome 1 offer~ increasing re~istance to applied pres~ure, directed inward, until said dome i~ deformed to an extent that it begins to undergo an inver~ion. At this point, resistance to the applied pres~ure decreases rapidly such that khe central region of dome 1 containing the barb is accelerated inward and toward aperture 7 of pres~ure plate 3. With continued pres~ure dome 1 i~ inverted, directing barb 2 through aperture 7 and into the adjacent ~k.in, thereby creating a pun~ture ~ite.
An alternative e~bodiment is contemplated wherein ~aid cover plate 21 and said pre~sure plate 3 are ~ade from a ~ingle piec~ of m~terial. Cover plate 21 and pres~ure plate 3 are folded aqainst each other ~o a to ~hare a common edge, the outer edge~ o~ each plate being 3ecured to one another utilizing weld~ 4 or crimp~ 6 a~ discussed previou31y herein.
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In it~ inverted ~tate, dome 1 a~sume~ an essentially cantilever configuration whieh accumulate~ a Porce opposing the inver~ion and aids in the re~ilient return ~he dome 1 to it~ convex configuration.
Figures 5 and 6 disclo~e an alternative embo~iment 30 of the ~kin perforator~ The pressure plate 33 i~ preferably made from a molded plastic material and i es~entially annular in shape. A convex dome 31, similar to dome 1 o figure 1 and having a point penetrating barb 32, i~ ~eated on a ~tep 38 and inside o~ an outer rim 35 in pres~ure plate 33. Pressure plate 33 contain~ an aperture 37 in its center which allowg pa~sage of barb 32 therethrough. Shelf 34 ~erve~ to stop the inversion of dome 31, thereby controlling the depth of barb 32 into the patient'~ skin.
In order to achieve a quicX and relatively painle~s penetration of the sXin, distance D between the peak of dome 31, in its undepressed state, and ~helf 34 of pressure plate 33 is preferably at lea~t about .lO inches. ~hile this distance i~ not absolute, it ha~ been calculated to account for a minLmum ~troke depth, deflection waste and differences in pati.ent ~kin texture. According to the pre~ent embodiments, the minimum dep~h ~trok~ i~ identified a3 that di~tance naceesary for the dome to undergo it~ inver~ion and is e~t~mated at .050 inches. The defleckion wa~te refer~ to the movement o~ the dome 31 toward the puncture ~ite upon the application o~ force but prior to the dome'~ inver~ion and i~
calculated at about .025 inches. Approximately .030 inche~ i~
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necessary to account for difference~ in the thickne~s and texture of the skin at th~ puncture ~ite. A di~tance D
ranging from about 0.075 inches to about 1.025 inches insure~
penetration of the skin coupled with a positive xeturn of the invert~d dome to its convex con~iguration.
The present device 20 i3 de~igned to perforate the skin on the finger of the patient. The finger ~hould be prepared 80 as to cleanse and remove as many contaminate~ from the perforation ~ite a~ i~ pos~i~le using technique~ which are well known in the art.
Optionally, any of the embodiments disclosed herein are contemplated as c~pable of incorporating a ~elf-contained cleaning means di~closed in figure 7. Device 30 i~ shown as incorporating an absorbent pad, impxegnated with a clean~ing and/or di~infecting agent, affixed to the lower surface 39 of pre~ure plate 33, adjacent the patient'~ skin.
The absorbent pad 40 is intended to be made from any cotton, synthetic or other fiber commonly u~ed in the art fox ~ucll purpose ~nd capable of x~taining liquid thereinO The cleansing or di~infecting agents can be selected from any ~uch agents known in the art, including but certainly not limited to ethyl alcoholg i~opropyl alcohol or benzalkonium chloride.
The lower ~urfa~e 39 of pre~ure plate 33 i~ a~eptically covered or ~ealed to keep the surface free from contaminate~
and to prevent evaporation of the cleansing agent.
Immediately prior to u~e, a packaging ~eal i~ removed thus expo~ing the device and/or lower 8urface 39. The eventual . .,,: .
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puncture site can then be clean~ed or disinfected by rubbing lower ~urface 39 of device 30 over the site. Often time~, the puncture ~ite i~ A fingertip, at which time the device i~
simply rubbed between the thumb and fingertip. In thi~
manner, the eventual puncture site is clean~ed and prepared to receive the point penetrating barb.
Figure 8 reveals a means for preserving the ~terility of barb 32 until just prior to the time of desired use. This packing mean~ is disclosed a~ a tab 42 havins a base portion ~3 and a ~tem 44. The stem 44 i~ formed with a cavity 45 open at the end oppo~ite base 43. Cavity 45 ha~ a depth at lea~t equal to the length o~ barb 32 in dome 31. Cavity 4S i8 capable of receiving a wax or other medium exhibiting properties of a ~olid at or above room temperature but lique~ying in the presence of heat. Additionally, such medium mu~t possess the a~ility to prevent or :re~i~t the growth of bacteria, fungi and other microbe~, either inherently or by the addition of antLmicrobialR.
Following the ~terilization of barb 32 after a~se~bly, cavity 45 in st~m 44 i~ ~illed with a medium 46 in a liquid or ~emi-solid ~tate. Immediately thereafter, barb 32 is in~erted into the medium contained in cavity 45u Thereupon cooling, a frangible connection between tab 42 and barb 32 i3 for~ed.
Tab 42 i~ removed pxior to u~e of the ~kin perforator by pliably moving tab 42 relative to device 30. Other mean~ of frangibly connecting tab 42 about barb 32 a~ are ~nown in the 2089~3~
art to accomplish the same or elmilar puxpose, are contemplated, ~uch a~ ultrasonic welding and the like.
~ urning again to Fig8. 1-3 but having applicability to all embodiment~, the device 20 i~ operated by positioning ~aid deYice 20 against the patient's finger to be punctured ~o that the intended puncture ~ite 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 patie~t or person as~isting the same. The initial applied pressure causes pressure plate 3 to be pre~sed against the ~kin of the patient further isolating the intended puncture ~ite. A~ additional pressure i~ applied to dome 1 the ~tress accumulation in the dome will re~ult in the ~udden inward collapsing of dome 1, directing barb 2 through aperture 7, thereby causing a piercing of the patie!nt's skin. Thi~ inward movement of barb 2 iB stopped a~ the irmer surface of dome 1 ~trike~ 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, ~ne collapse~ dome will resiliently return to its original ~hape and accordingly withdraw barb 2 ~rom the patient'~ finger~ The maintenance of a mall amount of pres~ure again~t pre~3ure pl~te 3, but pre~ure insufficient to cause collap~ o~ dome 1, will create a ten3ion to ~he area around the puncture ~i~e, re~ulting in an enhanced ~nd continuou~ blood flow from the puncture ~ite. Thi~ applied tension ha~ a two-fold effect w$th re~pect to enhanced blood .
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~low. Fir~t, this ten~ion maintain~ the skin in a ~tretched po~ture which holds edge~ o the puncture ~ite apart. Second, the pres~ure applied to the region surrounding the puncture site forces blood out of this ti~sue and into adjacent ti~sue which may be outside or inside of ~his ring of applied pressure. The blood directed inward ~eekR relief from thi~
pressure and as a result exit~ through the puncture site~
Flow enhancement of the blood from the puncture ~ite i~ also increased by the creation of a partial vacuum or pressure differential within the con~ined area defined by dome ~, pressure plate 3 and the patient' 8 finger. Thi~ area as defined while the dome i~ in the collapsed position, has a comparatively reduced volume compared to the ~ame area with dome 1 in it~ original po~ition. While in the depressed position, the ~er~on administrating the applied force may simply cover or obstruct aperture 10 ~ormed from the stamping of barb 2, as the pressure i~ withdrawn. Thi~ sudden increa~e in volume ln the area enclosed by the pr~s~ure plate 3 and dome 1 creates vacuum at the aperture 7. The vacuum causing free flow of blood fxom the puncture ~ite.
After the barb has been withdrawn from the ~inger, the di~po~able ~kin perforator can be removed and a blood ~ample collected a~ in prior art device~ by ~queezing the finger, if nece~ary.
To further effect a vacuum in the confined area of p~rforator device 20, a ~eal or ga3ket 25 can be placed b~tween the cover plate 21 ~nd the pre~ure plate 3 a~ i~
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shown in Fi~. 3. ~his ~eal or ga~ket 25 can be made fro~ a variety of flexible pla~tic or rubber materials as i~ well ~nown in the art and ~erve~ to prevent air pa~sage into and out of the confined area of per~orator devi~e 20 through the contact between the peripheral edges o~ cover plate 21 and peripheral plate 3. A preferred manner of creating a 3eal or gasket 25 is to apply a laminate to the inner ~urface of either the cover plate 21 or the pressure plate 3~ Such laminate becomes sandwiched between cover plate 21 and pre~sure plate 3 during the application of weld~ 4 or erImp~
6. :
Still another embodiment which i~ contemplated to create a vacuum for improving flow enhancement i~ a formation of one or more steps 26 in pressure plate 3. These step~ 26 are e~entially projections of varying widt]h formed on the inner surface of pre~sure plate 3 or cover pliate 21 along its periphery and located between the crimper 6 or weld~ 4. Steps 26 are of sufficien~ ~ize ~o as to extend into the area defined by and below the dome 1. Step~ 26 do not interfere with the depres3ion of the dome but contac~ the oppo~ing ~urface after substantial depresRion of the dome. A3 do~e 1 i~ depre~sed to e~fectuate a puncture, step~ 26 cause 3ufficient de~lection along the periphery of cover plate 21 to ~orm a temporary break in the ~eal between ~over pla~e 21 and pre~ure plate 3 as shown in ~i~.4. Thi~ break allow~ for the exit of air txapped within the confined area of ~he perforator device 20. Following puncture of the finger by : , , - .
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barb 2, and the gradual withdrawal o~ the applied pre~ure from dome 1, the ~eal 25 i3 refor~ed thereby creating th2 .
vacuum to enhance blood flow from the puncture site.
The present invention, in a further preferred em~odiment, compri~es an ab~orbent teRt strip S and i3 best illu~trated in the cross-sectional views of Fig~ 2 and 3. Test ~trip 8 i~
di~closed as generally a pad or ~heet of material capable of absorbing blood or exudate from the puncture site created by barb ~. The test strip 8 is contemplated as being treated or coated with various reagents which react with the blood or exudate to cau~e color or chemical changes which then can be quantitatively or qualitatively compared to a known ~t~ndard.
Mo~t home use test ~trip~ utilize color change techni~ues and yield fairly quic~ results which can be interpreted by comparing the te~t strip to a col~r coded chart provid~d with the device. The most common test strip contemplated is ~hat used for the determination of tbe patient' 9 blood sugar level.
The technology of ~uch test strips i~ well known in the art.
~ est strip 8 ia disclosed a~ being laminated to the outer ~urface of pre~ure plate 3. Lamination may be done u~ing known adhe~ive~ or by mean~ of crimp~ 6. Te~t stxip 8 may be of varying ~hapes or size~ but pxe~rably ha~ a length ~lightly greater than the diameter of aperture 7. Although, not required, te3t ~trip 8 contain~ a aperture dimen~ioned and po~itioned to allow pa3~age of barb 2 therethrough. In ~his embodiment the device ie u~ed ~i~ilar to tha~ a~
described previously herei~. However, te~t ~trip 8 i~
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positioned i~mediately adjacent to ~he patient's finger with the aperture 9 in the test strip 8 identifying the int~nded t2~t 3ite .
Following the puncture of the patient~ 8 finger by barb 2, the disposable ~kin perforator 20 remain~ in contact with the finger to allow the blood or exudate from the puncture ~ite to be absorbed onto test strip 8. Maintenance of a pressure pres~ing pressure plate 3 against the finger, but whi~h i~
insufficient to cause collap~e of dome 1, will enhance blood flow as previously described and allow for ~aturation of test ~trip 8 with the blood or exudate from the puncture site.
Thi~ device, incorporatin~ test ~trip 8 place3 the test medium Lmmediately adjacent to the puncture site and allows blood collection and testing to begin immediately upon puncture. Furthermore, test 3trips 8 riepre~enting various thickness may be u~ed. Such ~trips 8 clan extend into the rece~sion found in the bottom sur~ace of pressure plate 3 by ~helf 23. In a le~ preferred, but contemplated emhodiment, te3t strip 8 would omit the formation of aperture 9 therein.
Barb 2 i~ of suficien~ length and sharpnes~ to cut test strip 8 ~imultaneously with the skin of the fingertip. However, it i8 thought tha~ such a practice may permit ~he introduction of fibrou~ material from te~t ~txip 8 into the puncture ~ite formed by barb 2.
The ~kin perorators of the pre~ent invention are intended as di~po~able or single use device~, unle~ the devices are resterilized after each u~e by means ~nown in the : .
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art. In this way, the risk o~ patient contamination re~ulting from the use of un~terile or tainted device~ is minimized. In furtherance of thi~ objective, the ~kin perforator shown in figures 8-17 incorporate a shutter means ~or preventing repeated u~e of the device~
Generally, the device i fully functional upon it~
removal from the a~eptic packaging. The device is used to perforate the skin of a patent for the purposes of obtaining a blood ~ample by placing the pres~ure plate in contact with the ~kin and applying force to the convex dom~ as previously de~cribed. In these embodiments, the force applied to cause inver~ion of the dome resulting in the puncture of dome by barb 32 is also utilized to fracture or otherwise di~able a ~top member functioning to hold a shutter device in it~
ten~ioned position. Vpon retraction of the dome, the shutter means will advance to its untensioned po~ition between barb 32 and aperture 37. In this way, sub~equent attempts to utilize device 30 as a skin ~erforator will force barb 32 against the ~hutter, preventing puncture of the patient'~ skin. Once the shutter mean~ ha~ advanced to its untensioned po~ition be~ween barb 32 and aperture 37, the device i8 di~abled and to be discarded.
Specificallyr ~igure~ 9-12 illustrate one embodLment of a shutter means for preventing repeated u~e of a skin perforator. Figures 9 and 11 di~clo~e the ~hutter mean~
generally 50, having a ~hield portion 52 and ~ ~tem portion 54. The ~tem 54 is contemplated as an e~entially rigid ':
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2~8~039 material having a ~ubstantially long term memory ~o as to r~turn to it~ original unten~ioned po~itlon even after extended periods of time in a ten~ioned state. Such ~uitable materials include but are not limited to variou3 type~ of pla~tics or aluminum. The proximal end of ~tem 54 i8 5hown as attached to an inn~r wall of the pressure plate 33 although it is to be recognized that alternative ~ites of attachment are possible.
A ~hield member 52 is secured to the di~tal end of ~tem 54. The shield member 52 i8 intended a~ having a total axea approximately equal or greater to aperture 37.
Stop member 56 is located between aperture 37 and shutter mean~ 50 and serves to maintain the shutter mean~ 5D in a ten~ioned position until completion of the device's initial use. Step member 56 is intended to be con3tructed with ~ufficient strength to enable it to hol.d shutter mean 50 in a t~nsioned position but capable of fra.cturing, deforming9 pivoting or otherwi~e yielding to the ~orce of the ~kin perforator's activating mechani~m, in this ca~e the dome, in order to relea~e th~ ~hutter mean~ thereby preventing further u ~ of this particular device.
Stop mem~er 56 i~ co~t~mplated a~ being made from material similar to pressure plate 33 and formed integrally therewithO A frangible oonnection or weakened portion 58 i8 ~or~ed therein but po~e~ing sufici~nt strength to with~tand the pres~ure of a ten8ioned ~hutter mean~ 50. Upon compre~sion of dome 31 from applied force, the frangibl~
~ ! :
~, -connectio~ ~8 is broken a~ the barb penetrate~ the ~kin. Upon retraction of dome 31 to its original po~itio~, ~hutter mean3 50 advance~ to it~ untensioned po~ition as illu~trat~d ln figure~ 11 and 12 with ~hield 52 covering aperture 37O In this way, ~ubRequent attempt~ to utilize device 30 will re~ult in the barb'~ contact with ~hield 52 thereby preventing additional puncture~ of the ~kin using the same devi~e.
Figure~ 13~16 illustrate an alternative 3hutter mean~ 60 utilizing the same general principle~ previously discu~sed.
Shutter ~tem 64 is secured to an inner wall of pr~ssure plate 33 by any means known in the art and i~ formed from any coxrugated material capable of returning to an ~longated po~ition following compre~sion. Stop member 66 is di~clo~ed a~ a rai~ed projection originating from ~urface 34 and formed integrally therefrom. Stop member 66 i~ compre~sed into a void or weakened region of pre~sure plate 33 by the force of the dome 31 a~ it direct the barb 32 into the skin.
The shuttle means a~ illustra~ed in the embod~men~
previou~ly disclo~ed herein need only pos~es~ sufficient tension to enable it to position itself bekween th~ barb and the aperture. Preferably the ten~ion applied to the shutter means i~ not ~o great a~ to cause contact with the barb, while in the p~tient~ ~kin. Alternatively, a retaining ~eans 68 a~
shown in Fig. 14 may be formed in or on dome 31 to delay the advance of the ~hutter mean~ to it~ untensioned pv~ition until aft2r the barb i~ withdrawn from th~ puncture ~ite.
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: Figure 17 show~ a dome 31 and shutter means 70 formed a~
a ~ingle unit fro~ resilient metal or plastic materials. One such embodiment i9 contemplated a~ being formed from the stamping of a resilient metal material a~ de~cribed previou~ly with respect to dome lo 5hutt~r means 70 is folded towards the interior of dome 31 along line 75. During assembly, stem 74 i~ compressed in order that shutter 70 is retained in a tPnsioned state until actuated by a stop member. The shuttex means detailed in the dra~ings and ~pecification of this application are illustrative and not to be construed a~ limited to the specific embodiment~ set forth herein. It i~ contemplat~d that th~ self-contained cleansing means and the shutter means have application well beyond the scope of the specific embodiment~ of skin perforators di~clo~ed in this application.
: Hence the foregoing embodiment~ are designed t~ be simple -:
in construction, economical to manufacture and capable of being packaged under ~terile conditions. The various embodiment~ of the present invention are contemplated as being either disposable or reusable following sterilization using known ~echnique~. While in accordan~e with t~e patent statute~ the be~t mode and preferred embodiment of the invention have been de~cribed, it i~ to be under3tood that the invention i8 not limited thereto, but i9 rather to be mea~ured by the ~cope and the spirit o~ the appended ~laim~.
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 embsdiment of the present invention relates to a single u~e device ~or obtaining a blood sample employing a means for preventing multiple use of the device.
~ackgro~nd of the In~e~iQ~
Blood te3ting is a common practice,. The samples can be derived by merely pricking the fingertip with a sharp tool.
Then, the ~ample~ mu~t be ~xposed to proper test medium to ac~uire the test resultO
In the pa~t, a complex, sudden release, pen type device with dispo~able blades was uaed to perforate the 3kin painlessly. Once the ~kin was cut, separate test medium was introduced to the blood ~ample.
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~mmary Q the_lnYe~ti~n In accordance with the embodiments of the present invention, thi~ device i5 a di~posable skin perforator for obtaining a sample of blood by puncturing the skin. A further embodiment di~clo~s a test medium attached to a pres~ure pl~te on the device which can absorb blood flowing from the puncture.
Therefore~ one objective of my invention is to provide a simple, painless and inexpPnsive fingertip perforator that draw~ a sample of blood for testing and self-analy~
Another objective of my invention i~ to provide a convenient holding mean~ for litmus paper and other type test medium in such a way to allow for s~tu~eation of the te~t medium with blood while it i~ drawn.
A third objective of my invention is to provide a package that consists o~ a chart and bandage~ The chart can be color coded to read the test re3ult~ while the bandage can be used to protect the cut fin~er.
A further object of my invention is t~ provide a skin per~orator for obtaining a blood sample which pos~esses a ~elf-contained mean~ for clean~ing and/or di~infecting the puncture 3ite, prior o perforation of the skin.
S~ill a further object o~ my invention i~ to pro~ide a ~kin perfora~or ~or obtaining a blood sample whi~h employ~ a mean~ for preventing multiple use of the ~ame device. Other '"
., 208903~ ~
objective~ of my invention will become clear with reference to the accompanying figure~.
~xief Descri~tion ~f ~he D~m ~a Figure 1 i~ a plan view o~ the perforator device.
Figure 2 i3 a cro~-sectional view taken on line 2-2 of Figure 1.
Figure 3 i~ a cross-sectional view 3imilar to Figure 2 further illustrating a sealing mean~ and a step formed on the 3urface of preR~ure plate.
Figure 4 i~ a cutaway cros~-~ectional view illustrating the dome in a depressed position and a step causing the formation of a ~eans for air exchange.
Figure 5 i~ a cros~-sectional view o~ an alternative embodiment of a skin perforator according to my invention illu~xating a dome its uncollapsed position.
~ igure 6 i~ a cross-sectional view of the ~kin perforator sh~wn in Figure 5 and illustrating the dome in it~ collap~ed po~ition~
Figure 7 i~ an ~ot~om eleva~ional view of an alternative embodiment of a 3kin perforator according to my pre3ent invention illu~trating a s~lf-contained means for cleaning and/or di~infectillg the puncture ~ite.
Figure 8 18 ~ cross-~ectional view of ~kin perfor~tor according to my pre~ent invention and illu~trating a removable .
.
~8~9 guard incorporated therein for maintaining the sterility o~
barb untll u~e.
Figure 9 ~s a top elevational view of a kin perforator according to my present invention illustra~ing a ~hutter mean~
for preventing multiple u~e, in it~ ten~ioned ~tateO
Figure 10 i8 a cross-~ectional view of the ski~
perforator in figure 9, taken acros~ line 10-10.
Figure 11 is a top elevational view of the ~kin perforator shown in figures 9 and 10, illu~trating the shutter means in its untensioned state, Figure 12 i~ a cross sectional view of the skin perforator shown in figu.re 11, taken along line 12-12.
Figure 13 i~ a top elevational view of a skin perforator according to my present invention illu~trating an alternative shutter means for preventing multiple u~3e in it~ ten~ioned 3tateO
Figure 14 is a cro~s-sectional view of the ~kin perforator ~hown in figure 13 taken along line 14-14.
Figure lS i~ a top elevational view of the skin perforator shown in figure~ 13 and 14 and illu~trating the ~hutter means in it~ unten~ioned ~tate.
~ igure 16 i~ a cro~ ectio~al view of the ~Xin per~orator a~ ~hown in figure 15 taken along line 16-16.
Figure 17 i~ a top elevational view of a convex dome for a skin perforator according to my present inve~tion having inteqrally ~ormed shu~ter ~ean~.
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2~9~
De~ailed Dç~cri~ n of ~h8 Preferred ~mb~im~~
~ ow with reference to the invention illu~trated in the drawings, and looking particularly at figure 1, this figure ~hows a top plan view of the perforator device 20. Perforator devi~e 20 comprise~ generally a cover plate 21 and a pre~sure plate 3 of essentially similar ~ize and ~hapè po~itioned adjacent to one another and attached by a plurality of weld~ 4 and/or crimps 6.
Cover plate 21 has a spherical ~haped dome 1 formed therein so as to define a convex surface with re~pect to ~aid c3ver plate 21 and directed outward and away from said pre~eure plate 3. Cover plate 21 with ~pherical dome 1 formed integrally therein i~ made of a resilient plastic or thin metal material having a ~ubstan~ial memory ~o tha~ a~ dome 1 is deflected inward by a force it will return to essentially it~ original shape upon the removal of ~aid force.
Pressure plate 3 i8 to have a rigid ~tructure as compared to dome 1 and may b~ made from any plastic or ~etal material capable of maintaining such rigidity. Welds 4 or crImps 6 of varying number and ~ize are contemplated~ Pressure plate 3 has an aperture 7 formed generally in the ~enter of said pre~3ure pla~e 3 and having 3ufPicient diameter to allow the passage of a barb 2 through the aperture 7. Shelf 23 define3 the periphery of ~aid aperture 7.
A b~rb 2 i~ formed in ~ portion of dome 1 utilizing ~tamping method~ which are well known in the axt. Barb 2 remains integral with dome 1 alonq edg~ 24 of barb 2. Barb 2 :
.
20~39 iY disclosed as being es~entially triangular in ~hape however, any ~hape which yield~ a point capable of piercing the human 8ki~ i8 contemplated. The ~tamping of dome 1 to form barb 2 re~ults in an aperture having e~entially the ~ame dimen~ion~
a~ said barb 2. Barb 2 i~ formed ~o a~ ko be directed inward and toward the aperture 7 of plate 3. After Btamping~ 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 edge~ of barb 2 can be a~hieved by grinding the ~ame, but grinding currently appears not to be a co~t effective method as related to this application.
Dome 1 serve~ as a ~tres~ accumulating mean~ wherein ~aid dome 1 offer~ increasing re~istance to applied pres~ure, directed inward, until said dome i~ deformed to an extent that it begins to undergo an inver~ion. At this point, resistance to the applied pres~ure decreases rapidly such that khe central region of dome 1 containing the barb is accelerated inward and toward aperture 7 of pres~ure plate 3. With continued pres~ure dome 1 i~ inverted, directing barb 2 through aperture 7 and into the adjacent ~k.in, thereby creating a pun~ture ~ite.
An alternative e~bodiment is contemplated wherein ~aid cover plate 21 and said pre~sure plate 3 are ~ade from a ~ingle piec~ of m~terial. Cover plate 21 and pres~ure plate 3 are folded aqainst each other ~o a to ~hare a common edge, the outer edge~ o~ each plate being 3ecured to one another utilizing weld~ 4 or crimp~ 6 a~ discussed previou31y herein.
~ '''-: , 2 ~ 3 ~
In it~ inverted ~tate, dome 1 a~sume~ an essentially cantilever configuration whieh accumulate~ a Porce opposing the inver~ion and aids in the re~ilient return ~he dome 1 to it~ convex configuration.
Figures 5 and 6 disclo~e an alternative embo~iment 30 of the ~kin perforator~ The pressure plate 33 i~ preferably made from a molded plastic material and i es~entially annular in shape. A convex dome 31, similar to dome 1 o figure 1 and having a point penetrating barb 32, i~ ~eated on a ~tep 38 and inside o~ an outer rim 35 in pres~ure plate 33. Pressure plate 33 contain~ an aperture 37 in its center which allowg pa~sage of barb 32 therethrough. Shelf 34 ~erve~ to stop the inversion of dome 31, thereby controlling the depth of barb 32 into the patient'~ skin.
In order to achieve a quicX and relatively painle~s penetration of the sXin, distance D between the peak of dome 31, in its undepressed state, and ~helf 34 of pressure plate 33 is preferably at lea~t about .lO inches. ~hile this distance i~ not absolute, it ha~ been calculated to account for a minLmum ~troke depth, deflection waste and differences in pati.ent ~kin texture. According to the pre~ent embodiments, the minimum dep~h ~trok~ i~ identified a3 that di~tance naceesary for the dome to undergo it~ inver~ion and is e~t~mated at .050 inches. The defleckion wa~te refer~ to the movement o~ the dome 31 toward the puncture ~ite upon the application o~ force but prior to the dome'~ inver~ion and i~
calculated at about .025 inches. Approximately .030 inche~ i~
~ . , 3 ~
necessary to account for difference~ in the thickne~s and texture of the skin at th~ puncture ~ite. A di~tance D
ranging from about 0.075 inches to about 1.025 inches insure~
penetration of the skin coupled with a positive xeturn of the invert~d dome to its convex con~iguration.
The present device 20 i3 de~igned to perforate the skin on the finger of the patient. The finger ~hould be prepared 80 as to cleanse and remove as many contaminate~ from the perforation ~ite a~ i~ pos~i~le using technique~ which are well known in the art.
Optionally, any of the embodiments disclosed herein are contemplated as c~pable of incorporating a ~elf-contained cleaning means di~closed in figure 7. Device 30 i~ shown as incorporating an absorbent pad, impxegnated with a clean~ing and/or di~infecting agent, affixed to the lower surface 39 of pre~ure plate 33, adjacent the patient'~ skin.
The absorbent pad 40 is intended to be made from any cotton, synthetic or other fiber commonly u~ed in the art fox ~ucll purpose ~nd capable of x~taining liquid thereinO The cleansing or di~infecting agents can be selected from any ~uch agents known in the art, including but certainly not limited to ethyl alcoholg i~opropyl alcohol or benzalkonium chloride.
The lower ~urfa~e 39 of pre~ure plate 33 i~ a~eptically covered or ~ealed to keep the surface free from contaminate~
and to prevent evaporation of the cleansing agent.
Immediately prior to u~e, a packaging ~eal i~ removed thus expo~ing the device and/or lower 8urface 39. The eventual . .,,: .
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. : :
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.: :
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puncture site can then be clean~ed or disinfected by rubbing lower ~urface 39 of device 30 over the site. Often time~, the puncture ~ite i~ A fingertip, at which time the device i~
simply rubbed between the thumb and fingertip. In thi~
manner, the eventual puncture site is clean~ed and prepared to receive the point penetrating barb.
Figure 8 reveals a means for preserving the ~terility of barb 32 until just prior to the time of desired use. This packing mean~ is disclosed a~ a tab 42 havins a base portion ~3 and a ~tem 44. The stem 44 i~ formed with a cavity 45 open at the end oppo~ite base 43. Cavity 45 ha~ a depth at lea~t equal to the length o~ barb 32 in dome 31. Cavity 4S i8 capable of receiving a wax or other medium exhibiting properties of a ~olid at or above room temperature but lique~ying in the presence of heat. Additionally, such medium mu~t possess the a~ility to prevent or :re~i~t the growth of bacteria, fungi and other microbe~, either inherently or by the addition of antLmicrobialR.
Following the ~terilization of barb 32 after a~se~bly, cavity 45 in st~m 44 i~ ~illed with a medium 46 in a liquid or ~emi-solid ~tate. Immediately thereafter, barb 32 is in~erted into the medium contained in cavity 45u Thereupon cooling, a frangible connection between tab 42 and barb 32 i3 for~ed.
Tab 42 i~ removed pxior to u~e of the ~kin perforator by pliably moving tab 42 relative to device 30. Other mean~ of frangibly connecting tab 42 about barb 32 a~ are ~nown in the 2089~3~
art to accomplish the same or elmilar puxpose, are contemplated, ~uch a~ ultrasonic welding and the like.
~ urning again to Fig8. 1-3 but having applicability to all embodiment~, the device 20 i~ operated by positioning ~aid deYice 20 against the patient's finger to be punctured ~o that the intended puncture ~ite 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 patie~t or person as~isting the same. The initial applied pressure causes pressure plate 3 to be pre~sed against the ~kin of the patient further isolating the intended puncture ~ite. A~ additional pressure i~ applied to dome 1 the ~tress accumulation in the dome will re~ult in the ~udden inward collapsing of dome 1, directing barb 2 through aperture 7, thereby causing a piercing of the patie!nt's skin. Thi~ inward movement of barb 2 iB stopped a~ the irmer surface of dome 1 ~trike~ 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, ~ne collapse~ dome will resiliently return to its original ~hape and accordingly withdraw barb 2 ~rom the patient'~ finger~ The maintenance of a mall amount of pres~ure again~t pre~3ure pl~te 3, but pre~ure insufficient to cause collap~ o~ dome 1, will create a ten3ion to ~he area around the puncture ~i~e, re~ulting in an enhanced ~nd continuou~ blood flow from the puncture ~ite. Thi~ applied tension ha~ a two-fold effect w$th re~pect to enhanced blood .
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3 ~
~low. Fir~t, this ten~ion maintain~ the skin in a ~tretched po~ture which holds edge~ o the puncture ~ite apart. Second, the pres~ure applied to the region surrounding the puncture site forces blood out of this ti~sue and into adjacent ti~sue which may be outside or inside of ~his ring of applied pressure. The blood directed inward ~eekR relief from thi~
pressure and as a result exit~ through the puncture site~
Flow enhancement of the blood from the puncture ~ite i~ also increased by the creation of a partial vacuum or pressure differential within the con~ined area defined by dome ~, pressure plate 3 and the patient' 8 finger. Thi~ area as defined while the dome i~ in the collapsed position, has a comparatively reduced volume compared to the ~ame area with dome 1 in it~ original po~ition. While in the depressed position, the ~er~on administrating the applied force may simply cover or obstruct aperture 10 ~ormed from the stamping of barb 2, as the pressure i~ withdrawn. Thi~ sudden increa~e in volume ln the area enclosed by the pr~s~ure plate 3 and dome 1 creates vacuum at the aperture 7. The vacuum causing free flow of blood fxom the puncture ~ite.
After the barb has been withdrawn from the ~inger, the di~po~able ~kin perforator can be removed and a blood ~ample collected a~ in prior art device~ by ~queezing the finger, if nece~ary.
To further effect a vacuum in the confined area of p~rforator device 20, a ~eal or ga3ket 25 can be placed b~tween the cover plate 21 ~nd the pre~ure plate 3 a~ i~
2~8~3~
shown in Fi~. 3. ~his ~eal or ga~ket 25 can be made fro~ a variety of flexible pla~tic or rubber materials as i~ well ~nown in the art and ~erve~ to prevent air pa~sage into and out of the confined area of per~orator devi~e 20 through the contact between the peripheral edges o~ cover plate 21 and peripheral plate 3. A preferred manner of creating a 3eal or gasket 25 is to apply a laminate to the inner ~urface of either the cover plate 21 or the pressure plate 3~ Such laminate becomes sandwiched between cover plate 21 and pre~sure plate 3 during the application of weld~ 4 or erImp~
6. :
Still another embodiment which i~ contemplated to create a vacuum for improving flow enhancement i~ a formation of one or more steps 26 in pressure plate 3. These step~ 26 are e~entially projections of varying widt]h formed on the inner surface of pre~sure plate 3 or cover pliate 21 along its periphery and located between the crimper 6 or weld~ 4. Steps 26 are of sufficien~ ~ize ~o as to extend into the area defined by and below the dome 1. Step~ 26 do not interfere with the depres3ion of the dome but contac~ the oppo~ing ~urface after substantial depresRion of the dome. A3 do~e 1 i~ depre~sed to e~fectuate a puncture, step~ 26 cause 3ufficient de~lection along the periphery of cover plate 21 to ~orm a temporary break in the ~eal between ~over pla~e 21 and pre~ure plate 3 as shown in ~i~.4. Thi~ break allow~ for the exit of air txapped within the confined area of ~he perforator device 20. Following puncture of the finger by : , , - .
.. ..
.,. ..- ~
:~
~89~3~
barb 2, and the gradual withdrawal o~ the applied pre~ure from dome 1, the ~eal 25 i3 refor~ed thereby creating th2 .
vacuum to enhance blood flow from the puncture site.
The present invention, in a further preferred em~odiment, compri~es an ab~orbent teRt strip S and i3 best illu~trated in the cross-sectional views of Fig~ 2 and 3. Test ~trip 8 i~
di~closed as generally a pad or ~heet of material capable of absorbing blood or exudate from the puncture site created by barb ~. The test strip 8 is contemplated as being treated or coated with various reagents which react with the blood or exudate to cau~e color or chemical changes which then can be quantitatively or qualitatively compared to a known ~t~ndard.
Mo~t home use test ~trip~ utilize color change techni~ues and yield fairly quic~ results which can be interpreted by comparing the te~t strip to a col~r coded chart provid~d with the device. The most common test strip contemplated is ~hat used for the determination of tbe patient' 9 blood sugar level.
The technology of ~uch test strips i~ well known in the art.
~ est strip 8 ia disclosed a~ being laminated to the outer ~urface of pre~ure plate 3. Lamination may be done u~ing known adhe~ive~ or by mean~ of crimp~ 6. Te~t stxip 8 may be of varying ~hapes or size~ but pxe~rably ha~ a length ~lightly greater than the diameter of aperture 7. Although, not required, te3t ~trip 8 contain~ a aperture dimen~ioned and po~itioned to allow pa3~age of barb 2 therethrough. In ~his embodiment the device ie u~ed ~i~ilar to tha~ a~
described previously herei~. However, te~t ~trip 8 i~
~89~
positioned i~mediately adjacent to ~he patient's finger with the aperture 9 in the test strip 8 identifying the int~nded t2~t 3ite .
Following the puncture of the patient~ 8 finger by barb 2, the disposable ~kin perforator 20 remain~ in contact with the finger to allow the blood or exudate from the puncture ~ite to be absorbed onto test strip 8. Maintenance of a pressure pres~ing pressure plate 3 against the finger, but whi~h i~
insufficient to cause collap~e of dome 1, will enhance blood flow as previously described and allow for ~aturation of test ~trip 8 with the blood or exudate from the puncture site.
Thi~ device, incorporatin~ test ~trip 8 place3 the test medium Lmmediately adjacent to the puncture site and allows blood collection and testing to begin immediately upon puncture. Furthermore, test 3trips 8 riepre~enting various thickness may be u~ed. Such ~trips 8 clan extend into the rece~sion found in the bottom sur~ace of pressure plate 3 by ~helf 23. In a le~ preferred, but contemplated emhodiment, te3t strip 8 would omit the formation of aperture 9 therein.
Barb 2 i~ of suficien~ length and sharpnes~ to cut test strip 8 ~imultaneously with the skin of the fingertip. However, it i8 thought tha~ such a practice may permit ~he introduction of fibrou~ material from te~t ~txip 8 into the puncture ~ite formed by barb 2.
The ~kin perorators of the pre~ent invention are intended as di~po~able or single use device~, unle~ the devices are resterilized after each u~e by means ~nown in the : .
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art. In this way, the risk o~ patient contamination re~ulting from the use of un~terile or tainted device~ is minimized. In furtherance of thi~ objective, the ~kin perforator shown in figures 8-17 incorporate a shutter means ~or preventing repeated u~e of the device~
Generally, the device i fully functional upon it~
removal from the a~eptic packaging. The device is used to perforate the skin of a patent for the purposes of obtaining a blood ~ample by placing the pres~ure plate in contact with the ~kin and applying force to the convex dom~ as previously de~cribed. In these embodiments, the force applied to cause inver~ion of the dome resulting in the puncture of dome by barb 32 is also utilized to fracture or otherwise di~able a ~top member functioning to hold a shutter device in it~
ten~ioned position. Vpon retraction of the dome, the shutter means will advance to its untensioned po~ition between barb 32 and aperture 37. In this way, sub~equent attempts to utilize device 30 as a skin ~erforator will force barb 32 against the ~hutter, preventing puncture of the patient'~ skin. Once the shutter mean~ ha~ advanced to its untensioned po~ition be~ween barb 32 and aperture 37, the device i8 di~abled and to be discarded.
Specificallyr ~igure~ 9-12 illustrate one embodLment of a shutter means for preventing repeated u~e of a skin perforator. Figures 9 and 11 di~clo~e the ~hutter mean~
generally 50, having a ~hield portion 52 and ~ ~tem portion 54. The ~tem 54 is contemplated as an e~entially rigid ':
:
:
2~8~039 material having a ~ubstantially long term memory ~o as to r~turn to it~ original unten~ioned po~itlon even after extended periods of time in a ten~ioned state. Such ~uitable materials include but are not limited to variou3 type~ of pla~tics or aluminum. The proximal end of ~tem 54 i8 5hown as attached to an inn~r wall of the pressure plate 33 although it is to be recognized that alternative ~ites of attachment are possible.
A ~hield member 52 is secured to the di~tal end of ~tem 54. The shield member 52 i8 intended a~ having a total axea approximately equal or greater to aperture 37.
Stop member 56 is located between aperture 37 and shutter mean~ 50 and serves to maintain the shutter mean~ 5D in a ten~ioned position until completion of the device's initial use. Step member 56 is intended to be con3tructed with ~ufficient strength to enable it to hol.d shutter mean 50 in a t~nsioned position but capable of fra.cturing, deforming9 pivoting or otherwi~e yielding to the ~orce of the ~kin perforator's activating mechani~m, in this ca~e the dome, in order to relea~e th~ ~hutter mean~ thereby preventing further u ~ of this particular device.
Stop mem~er 56 i~ co~t~mplated a~ being made from material similar to pressure plate 33 and formed integrally therewithO A frangible oonnection or weakened portion 58 i8 ~or~ed therein but po~e~ing sufici~nt strength to with~tand the pres~ure of a ten8ioned ~hutter mean~ 50. Upon compre~sion of dome 31 from applied force, the frangibl~
~ ! :
~, -connectio~ ~8 is broken a~ the barb penetrate~ the ~kin. Upon retraction of dome 31 to its original po~itio~, ~hutter mean3 50 advance~ to it~ untensioned po~ition as illu~trat~d ln figure~ 11 and 12 with ~hield 52 covering aperture 37O In this way, ~ubRequent attempt~ to utilize device 30 will re~ult in the barb'~ contact with ~hield 52 thereby preventing additional puncture~ of the ~kin using the same devi~e.
Figure~ 13~16 illustrate an alternative 3hutter mean~ 60 utilizing the same general principle~ previously discu~sed.
Shutter ~tem 64 is secured to an inner wall of pr~ssure plate 33 by any means known in the art and i~ formed from any coxrugated material capable of returning to an ~longated po~ition following compre~sion. Stop member 66 is di~clo~ed a~ a rai~ed projection originating from ~urface 34 and formed integrally therefrom. Stop member 66 i~ compre~sed into a void or weakened region of pre~sure plate 33 by the force of the dome 31 a~ it direct the barb 32 into the skin.
The shuttle means a~ illustra~ed in the embod~men~
previou~ly disclo~ed herein need only pos~es~ sufficient tension to enable it to position itself bekween th~ barb and the aperture. Preferably the ten~ion applied to the shutter means i~ not ~o great a~ to cause contact with the barb, while in the p~tient~ ~kin. Alternatively, a retaining ~eans 68 a~
shown in Fig. 14 may be formed in or on dome 31 to delay the advance of the ~hutter mean~ to it~ untensioned pv~ition until aft2r the barb i~ withdrawn from th~ puncture ~ite.
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: Figure 17 show~ a dome 31 and shutter means 70 formed a~
a ~ingle unit fro~ resilient metal or plastic materials. One such embodiment i9 contemplated a~ being formed from the stamping of a resilient metal material a~ de~cribed previou~ly with respect to dome lo 5hutt~r means 70 is folded towards the interior of dome 31 along line 75. During assembly, stem 74 i~ compressed in order that shutter 70 is retained in a tPnsioned state until actuated by a stop member. The shuttex means detailed in the dra~ings and ~pecification of this application are illustrative and not to be construed a~ limited to the specific embodiment~ set forth herein. It i~ contemplat~d that th~ self-contained cleansing means and the shutter means have application well beyond the scope of the specific embodiment~ of skin perforators di~clo~ed in this application.
: Hence the foregoing embodiment~ are designed t~ be simple -:
in construction, economical to manufacture and capable of being packaged under ~terile conditions. The various embodiment~ of the present invention are contemplated as being either disposable or reusable following sterilization using known ~echnique~. While in accordan~e with t~e patent statute~ the be~t mode and preferred embodiment of the invention have been de~cribed, it i~ to be under3tood that the invention i8 not limited thereto, but i9 rather to be mea~ured by the ~cope and the spirit o~ the appended ~laim~.
Claims (18)
1. 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 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.
a) a pressure plate containing an aperture formed therein wherein said pressure plate is placed adjacent to 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.
2. The skin perforator as recited in claim 1 wherein said perforator further comprises a means for controlling the penetration depth of said skin by said barb.
3. The skin perforator as recited in claim 1 wherein said perforator further comprises a pad attached to said pressure plate to absorb blood or exudate flowing from a puncture site formed by the penetration of said barb.
4. The skin perforator as recited in claim 3 wherein said pad is impregnated with a skin preparatory agent comprising one or more from the group consisting of ethyl alcohol, isopropyl alcohol, benzalkonium chloride, iodine, and topical antimicrobials.
5. The skin perforator as recited in claim 3 wherein said pad is an essentially annular ring circumscribing the aperture in said pressure plate.
6. The skin perforator as recited in claim 3 wherein said pad is treated with at least one reagent for medical analysis.
7. 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 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 aid 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 shutter means capable of occluding the aperture of said pressure plate following the initial penetration.
a) a pressure plate containing an aperture formed therein wherein said pressure plate is placed adjacent to 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 aid 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 shutter means capable of occluding the aperture of said pressure plate following the initial penetration.
8. The skin perforator as recited in claim 7 wherein said shutter means is activated by the inversion of said convex panel.
9. The skin perforator as recited in claim 7 wherein said shutter means comprises a shield 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 ten ion.
10. The skin perforator as recited in claim 7 wherein said skin perforator further comprises a stop member for retaining said shutter in a tensioned position.
11. The skin perforator as recited in claim 7 wherein said skin perforator further comprises a stop member for retaining said shutter in a tensioned position, said stop member has sufficient strength to retain said shutter in a tensioned position but yields to a force applied during the conversion of said convex panel so at to release the tension applied to said shutter.
12. The skin perforator as recited in claim 7 wherein said pad is treated with at least one reagent for medical analysis.
13. The skin perforator as recited in claim 7 further comprising a pad attached to said pressure plate to absorb blood or exudate flowing from a puncture site formed by the penetration of said barb.
14. The skin perforator as recited in claim 13 wherein said pad is impregnated with a skin preparatory agent comprising one or more from the group consisting of ethyl alcohol, isopropyl alcohol, benzalkonium chloride, iodine, and topical antimicrobials.
15. A skin perforator for puncturing the skin, said perforator of the type comprising a housing having a contact surface for placement adjacent to the skin to be punctured, an aperture in said contact surface, a puncturing member operatively mounted within said housing for movement toward.
and through said aperture, upon the application of applied force said puncturing member penetrating into the skin, wherein the improvement comprises:
a shutter means for occluding the aperture of said skin perforator following initial puncture of the skin.
and through said aperture, upon the application of applied force said puncturing member penetrating into the skin, wherein the improvement comprises:
a shutter means for occluding the aperture of said skin perforator following initial puncture of the skin.
16. The skin perforator as recited in claim 15 wherein said shutter means is activated by the inversion of a convex panel forming a cover plate and retaining a puncturing member therein.
17. The skin perforator as recited in claim 15 wherein said shutter means comprises a shield portion and a stem portion, said shield 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.
18. The skin perforator as recited in claim 15 wherein said shutter means further comprises a stop member for retaining said shutter in a tensioned position, said stop member has sufficient strength to retain said shutter in a tensioned position but yields to a force applied during the movement of said puncturing member toward said aperture so as to release the tension applied to said shutter.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US32890789A | 1989-03-27 | 1989-03-27 | |
| US566,160 | 1990-08-10 | ||
| US07/566,160 US5054499A (en) | 1989-03-27 | 1990-08-10 | Disposable skin perforator and blood testing device |
| US732,109 | 1991-07-18 | ||
| US07/732,109 US5201324A (en) | 1989-03-27 | 1991-07-18 | Disposable skin perforator and blood testing device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2089039A1 true CA2089039A1 (en) | 1992-02-11 |
Family
ID=26986564
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002089039A Abandoned CA2089039A1 (en) | 1989-03-27 | 1991-08-07 | Disposable skin perforator and blood testing device |
Country Status (6)
| Country | Link |
|---|---|
| US (2) | US5054499A (en) |
| EP (1) | EP0544837B1 (en) |
| AU (1) | AU8920291A (en) |
| CA (1) | CA2089039A1 (en) |
| DE (1) | DE69128147T2 (en) |
| WO (1) | WO1992002175A1 (en) |
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-
1990
- 1990-08-10 US US07/566,160 patent/US5054499A/en not_active Expired - Fee Related
-
1991
- 1991-07-18 US US07/732,109 patent/US5201324A/en not_active Expired - Fee Related
- 1991-08-07 EP EP91919977A patent/EP0544837B1/en not_active Expired - Lifetime
- 1991-08-07 WO PCT/US1991/005616 patent/WO1992002175A1/en active IP Right Grant
- 1991-08-07 CA CA002089039A patent/CA2089039A1/en not_active Abandoned
- 1991-08-07 DE DE69128147T patent/DE69128147T2/en not_active Expired - Fee Related
- 1991-08-07 AU AU89202/91A patent/AU8920291A/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| EP0544837B1 (en) | 1997-11-05 |
| US5054499A (en) | 1991-10-08 |
| DE69128147T2 (en) | 1998-06-10 |
| WO1992002175A1 (en) | 1992-02-20 |
| DE69128147D1 (en) | 1997-12-11 |
| EP0544837A4 (en) | 1993-09-29 |
| AU8920291A (en) | 1992-03-02 |
| US5201324A (en) | 1993-04-13 |
| EP0544837A1 (en) | 1993-06-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |