CA2115197C - Lancet blade designed for reduced pain - Google Patents

Lancet blade designed for reduced pain

Info

Publication number
CA2115197C
CA2115197C CA002115197A CA2115197A CA2115197C CA 2115197 C CA2115197 C CA 2115197C CA 002115197 A CA002115197 A CA 002115197A CA 2115197 A CA2115197 A CA 2115197A CA 2115197 C CA2115197 C CA 2115197C
Authority
CA
Canada
Prior art keywords
blade
lancet assembly
assembly according
lancet
shear
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.)
Expired - Fee Related
Application number
CA002115197A
Other languages
French (fr)
Other versions
CA2115197A1 (en
Inventor
James A. Burns
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of CA2115197A1 publication Critical patent/CA2115197A1/en
Application granted granted Critical
Publication of CA2115197C publication Critical patent/CA2115197C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/150458—Specific blade design, e.g. for improved cutting and penetration characteristics
    • 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
    • A61B5/150374—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
    • A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
    • 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
    • A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
    • A61B5/1513—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising linear sliding guides
    • 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

Abstract

A lancet assembly having a blade designed for reduced pain that is used for piercing a patient's skin to cause capillary blood to flow for collection and testing.
The blade has a shear percentage greater than conventional lancet blades to provide additional cutting action when the blade is being inserted into a puncture wound and a blade width smaller than conventional lancet blades. Reduced width and increasedshear percentage result in reduced skin tear and penetration force, which therefore causes less pain to the patient during skin penetration.

Description

James A. Burns LANCET BLADE DESIGNED FOR REDUCED PAIN

10 Back~round of the Invention 1. Field of the Invention The present invention relates to a blade for a lancet and, more particularly, relates to a lancet blade designed for reducing the amount of pain inflicted when being 15 used to draw blood from a patient for diagnostic testing.
2. Background Description A lancet is a device commonly used in hospitals, doctors offices and 20 homes to pierce a patient's flesh to draw capillary blood for diagnostic testing.
Conventional lancets consist of a shank portion having at a distal end a blade or spike, which is sharp and adapted to pierce the patient's skin so to sever capillaries and provide blood for testing. Since the blade or spike is sharp, some lancets are provided with a removable shield for protectively 25 covering the sharp edge or point of the lancet's blade or spike f--when not in use to protect the patient and users from inadvertent s~in puncture.Fig. 1 is a perspective view of a conventional lancet assembly 10 described in U.S. Patent No. 4,577,630 (Nitzsche et al), which is assigned to Becton, Dickinson and Company. Lancet assembly 10 includes a handle portion 11, a spike 12 .oxt~.n-1ing 5 outwardly from a distal end 13 and a removable shield 14 adapted to mate with spike 12 when the lancet is not in use and protect users from a~ lf,.~lAl pullclult;. Spike 12 in lancet assembly 10 can also be replaced with a conventional lancet blade, likc that shown in Fig. 2. ;
As showr, in Pig. 2, con~ t;o l I lancet blade 20 has an included angle ~ of 10 60~, a blade width A of l.lmm, a blade length B of 1.85mm and a shear length C of 0.635mm. In addition, blade 20 has a shear pel~.l~e of 349~, wherein~
. .
SHEAR LENGTH C
~CHEA~ PERCENTAGE = BLADE LENGTH B (1) : .

An example of a conv~ ioi~al lancet as~-.~ , for holding blade 20, is flf.S.'~ d in U.S. Patent No. 4,616,649 (Burns), assigned to Becton, ~;c~;nson and Company, ~ ~ -which is similar to the 6356 Lancet sold by Becton, DiclLIlson and Ce , ~.
A problem with the lancets ~If '~ ed above is that during pf r-, -. ~ al the b!ade ~ -20 or spike initially cuts but then tears sensitive nerve endings where the p..nclul~ wound is made in a finger, which causes a d,. ~ amount of pain to the patient. When using blade 20 shown in Fig. 2, the skin is cut by a shearing action over the shear length C of the b1ade. IIo _._., after the shearing portion of the blade has been fully insened into tbe p~mclul~ wound, the blade continues to enter the skin without any 2S cuttingactionbeingpe.ro. l~dbytheblade. Sincethet; ' of blade20~,t;",~s .

... . ..

. . .

to increase beyond the sheared portion, additional blade thickness is forced into the puncture wound thus causing tearing of the skin, which results in increased pain to the patient. Such pain to the patient is very severe since the nerve endings in the finger 5 are very sensitive.

Summary of the Invention The present invention overcomes the problems identified in the background material by providing a lancet having a blade designed for reduced pain and reduced 10 penetration force. In a preferred lancet blade according to present invention, the blade has a decreased width and an increased shear percentage from conventional lancetblades. In addition, the lancet blade of the present invention has a cross-sectional thickness that approaches a maximum thickness close to the junction of the bladeportion and the base portion, which enables the blade to perforrn additional cutting 15 action as the blade is being inserted in the puncture wound and reduce skin tear.
An alternative embodiment of a lancet blade according to the present invention has a decreased width and a blade length A equal to shear length C to provide a shear percentage of 100%. A blade of this type causes even less pain to the patient since during the entire process of inserting the blade into the puncture wound cutting of the 20 skin is performed which results in reduced skin tear. Applicant has discovered that any increase in shear percentage also decreases penetration force which likewisereduces pain to the patient.
These and other aspects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the 25 accompanying drawings.

~llàl~7 DESCRlPrION OF THE DRAWINGS

Fig. 1 is a pe~ e view of a conventional lancet assembly;
Pig. 2 is a side view of a co.~ ional lancet blade;
Pig. 3 is a cross ~I ;o~ view of a lancet assembly in a retracted position having a pl~fcll.,d blade of the present i~.ie..tion;
Fig. 4 is a cross-sectionql view of the lancet a~.l-bl~ shown in Pig. 3 in an b d~d po~ition;
o Fig. 5 is an enlarged side view of the blade in the lancet assembly shown in Figs. 3 and 4; and Fig. 6 is an ~ blade ac~ld;ng to the present i ~v_.~tion.

DETAn~l~n DESCRIPIION
Fig. 3 shows a cross-s~ ' view of a lancet ass~ bly 30 that is similar to the lancet as~lbly df-~';l~ in U.S. Patent 4,616,649 ~- f ~ above. However, Flg. 3 shows a pl~,fc;..~,d blade 100 of the present il~ ion I ' in lan~t assemb;y 30 in place of the blade shown in U.S. Patent 4,616,649.
Lancet a~ , 30 shown in Fig. 3 includes a housing 31 and a slidably mounted lancet blade holder ?S ' ~ 32. Housing 31 includes an Pl~n~ ti~ lower por~on 33 and an upper flange pofion 34 having an ~ g ", g surface 35 and an integ~al upwardly ~ " g annular wall 36 which together define a space 37 for leceiving a pofion of lance~ blade holder assembly 32. A pair of arms 49 are located 2S within space 37 at the top of lower porlion 33, each arm 49 ~l ' g an integral -, .. ~.. - . . . : . .

.. . . . .. . .... .. ... .

CA 0211~197 1999-01-18 abutment 48 extending into a passageway 39 in housing 31. Passageway 39 is defined S by an internal surface 38 that extends from arms 49 in upper flange portion 34 to a lower end opening 51 at the base of lower portion 33. In operation, lancet bladeholder assembly 32 is received by and travels within passageway 39. Passageway 39 also has an enlarged portion 50 in upper flange portion 34, which receives the top portion of lancet blade holder assembly 32, described below.
Lancet blade holder assembly 32 includes an integral push-button top 4û with resilient springs 41 and 42 and a shank 43 extending therefrom, shank 43 being shaped to travel through passageway 39 in housing 31 during use. Pairs of integral abutments 46 and 47 extend from opposite sides of shank 43 to cooperate with theinternally extending integral abutments 48 extending from each arm 49 to controlmovement of lancet blade holder assembly 32 within housing 31. A boss 45 is located near a distal end 44 of shank 43 for receiving and holding blade 100 of the present invention, with boss 45 being cold staked into an opening 103 in a base portion 102 of blade 100.
Lancet assembly 30 is shown in Fig. 3 in a retracted position with a blade portion 101 of blade 100 surrounded by lower portion 33 of housing 31 and contained within lower end opening 51. In the retracted position, abutments 48 on arms 49 are engaged with abutments 46 and 47 on shank 43 which effectively holds lancet blade holder assembly 32 in a releasably fixed position within housing 31. In the position shown in Fig. 3, abutments 46 are located on the proximal side of abutments 48 which prevents shank 43 from sliding in the distal direction and provides a tactile indication to a user to indicate that lancet assembly 30 has not been used or activated.
However, after the lancet assembly 30 has been used, abutments 46 are located on and abut the distal side of abutments 48, as shown in Fig. 4, with pressure being applied by compressed resilient springs 41 and 42. In the position shown in Fig. 4, the user is .

able to feel by the soft support under push-button top 40 that lancet assembly 30 has been used.
To use lancet assembly 30, for example, the user holds housing 31 between a thumb and third finger and holds lower end opening 51 of housing 31 in contact with s the skin surface to be punct~lred on a patient's finger. The user then presses push-I)utton top 40 with a second finger to force shank 43 through passdge~.dy 39 towards lower end opening S l . As for~e is applied to push-button top 40, qbu~m~nt 46 is forced over abi~ e.~t 4~ which causes lancet blade holder assembly 32 to thrust forward and make ar, audible "snap", and project blade portion 101 beyond lower end lO opening 51 to ~ u~l~;lul~ the patient's skin. The "snapn b:~' '~ to the user that the lancet blade is fully f~,ct~n(~
Fig. 4 is a cross-sectionql view of lancet assembly 30 in an ~ ed position during use a~ter bemg activated, wherein blade portion 101 of blade 100 projectsbeyond lower end openiDg 51 of housing 31 and is piercing the patient's skin. In the 5 extended position, resilient springs 41 and 42 are coln~Jl~d within space 37 in upper flange portion 34 of housing 31 and hL - 48 on arms 4q are in contact with thebottom of push-button top 40, which stops distal end Illo~.,..le~l~ of shank 43. In this position, blade portion 101 of blade 100 will have y~lllclul~d the patient's skin ;o begin blood flowing from carillqn~-s in the patient's finger for testing y...yos~,s. After being 20 activated, the user release~s the pressure on pushbutton top 40 which allows colllplessed resilient springs 41 and 42 to withdraw lancet blade 100 from the pUll~;lUl~; wound.
More particularly, as pressure is released from push-button top 40 resilient springs 41 and 42 retract blade holder ~ ~ 32 into lower end opening 51 of housing 31 so that blade portion 101 is sul '~ d and contained within lower portion 33 of housing 25 31 for disposah Fig. 5 is an enlarged side view of the prefelTed blade 100 shown in Figs. 3 and 4. As dcsc.il,ed above, blade 100 includes blade portion 101 and base po}tion 102, with base portion 102 having an opening 103 for receiving boss 45 on shank 43 oflancet blade holder assembly 32. As shown in Fig. 5, blade po~tion 101 has a width A
of .60mm, a blade length B of 2.3mm, a shear length cf 0.874mm, and an included angle O of 45~. Using equation (1), defined above, the shear pelce.-t~ c,c for blade 100 is 38%. The inventor has discovered th..l inc~ash~g the shear pe.-,e.lL~ of a lancet blade, so that the blade performs more cutting action as it is piercing the patient's skin, reduces the overall p~ ;o~ force needed to pierce the patient's s!~n ~us reducing o the pain that the patient feels. In ~ lA;~ , the inventor has disoovered tha~ ucing the width of the blade and the blade length, within reason so to avoid jeop~ldiLii1g the qu..ntity of blood flowing from the ~ ..~ul~, also reduces p - force which likewise reduces pain during ~ - Blade 100 of ~ present in~ention includes a ~ -d~.~d blade width A of .60mm and an increased sbear pCl~ ~e ot 38 %, which ~5 c ' ~ provide a lancet blade that is much ~mproved over c;o~ lancet blades since it causes the pat:ent much less pain during pf "- Of course, the above- ;listed l~ - - are merely ~ - P~ - y. other ~ C;~AC. could aiso be used. For e , ', another e..ll~; e..l of bl2de 100 could ha~e a c s ~ l blade length of 1.5mm with a blade width A less than l.lmm, e.g., Imm, .60mm or .SOmm, or a 20 c~ ~. '~ -'bladewidthof l.lmmwi~han ~as~lshearpc..~ ~uptoto 100%.
Fig. 6 shows an alte~..ati~/e e...b~ of a lancet blade 110 for reduced pain, which is b' ~ in lancet blade ? ~ S ~ 'y 30 shown in Figs. 3 and 4 in place of blade 100. As shown, blade 110 has a base 112 wi~h an opening 113 that receives boss 45 on sbank 43 to mount and hold blade 110. Blade 110 also includes an e, ~cn~
2S blade portion 111 that is offset from the center of the I ~ ' I axis of blade 110.

~.: , . : . ....
~ ' .~ ' , . -; - - . ' . .

1 9 ~ ' Offset blade portion 111 pelTnits the edge of blade 110 to be easily ground to have a -cutting edge with a shear percentage of 100% In addition, blade 110 has a blade width A of 1.0mm, a blade length B of 2.3mm, a shear length C of 2 3mm and an included angle ~ of 25~. With a shear percentage of 100%, blade 110 con~innq-lly cuts s the patient's skin during penel.,nion which causes even less pain than conventional blades. The decreased width A of l.Omm on blade 110 also d~cltases the pain caused during penetr~i( n of the patient's skin, as desc.;hcd above with respect to blade 100.
As for mqn~ ctnrin~ lancet q-scembli~s with blades 100 and 110, the blades are made of surgical st~l ~nd ~re cold staked onto shank 43 of lancet assembly 30 10 using co..;~ ' ~ r ~l ...,. .r,,~ ~;.,,g techni~ues. Housing 31 and blade holder assembly 32 of assembly 30 are made of molded plastic. However, of course, these t~;ne teC~ v~s and lc are merely exemplary, various other r ~ h~g r.lethods and r/~riqlc could also be used.
In the fol~o ~ it is to be l~nrlpr~ood that the above~e~s~nhed lS ~im~n-~ are simply illustrative of a lancet blade that provides a reduction in the pain inflicted on a patient when piercing the patient's skin in accold~nce with the present invention. Other suitable ~ ions and l--o lil~ .nS could be made to these and still remain within the scope of the present i..~e.llion ... ... . ~ :

'- ~

Claims (20)

1. A lancet assembly comprising:
a housing having an upper and lower end with a passageway extending from said upper end to an opening at said lower end;
a blade holder having a shank slidably received in said passageway for movement from a retracted position to an extended position; and a blade mounted on said shank having:
(I) a base portion having a predetermined cross-sectional thickness;
(ii) a blade portion extending from said base portion to a distal point having a blade width from a first edge to a second edge of less than 1.1 mm and a cross-sectional thickness that decreases from said base portion to said distal point; and (iii) a shear portion that extends across the entire blade width from said first edge to said second edge, wherein said blade portion is surrounded by said passageway when said holder is in the retracted position and extends beyond said lower end of said housing when said holder is in the extended position.
2. A lancet assembly according to claim 1, wherein said blade has a shear length and a blade length that are equal.
3. A lancet assembly according to claim 1, wherein said blade portion has a length of at least 2.3 mm.
4. A lancet assembly according to claim 3, wherein said blade is sheared alongthe entire length of said blade portion.
5. A lancet assembly according to claim 1, wherein said blade portion has an included angle less than 60°.
6. A lancet assembly according to claim 5, wherein said blade has a shear percentage of 100%.
7. A lancet assembly according to claim 1, wherein said blade portion has an included angle no larger than 45°.
8. A lancet assembly according to claim 1, wherein said blade width is no larger than 1 mm.
9. A lancet assembly according to claim 1, wherein said blade width is no larger than 0.60 mm.
10. A lancet assembly according to claim 1, wherein said blade has a shear percentage larger than 34%.
11. A lancet assembly according to claim 1, wherein said blade has a shear percentage of at least 38%.
12. A lancet assembly comprising:
a housing having an upper and lower end with a passageway extending from said upper end to an opening at said lower end;
a blade holder having a shank slidably received in said passageway for movement from a retracted position to an extended position; and a blade with a shear percentage larger than 34% mounted on said shank having:
(i) a base portion having a predetermined cross-sectional thickness;
(ii) a blade portion extending from said base portion to a distal point having a predetermined blade width from a first edge to a second edge and a cross-sectional thickness that decreases from said base portion to said distal point; and (iii) a shear portion that extends across the entire blade width from said first edge to said second edge, wherein said blade portion is surrounded by said passageway when said holder is in the retracted position and extends beyond said lower end of said housing when said holder is in the extended position.
13. A lancet assembly according to claim 12, wherein said blade has a shear length and a blade length that are equal.
14. A lancet assembly according to claim 12, wherein said blade portion has a length of at least 2.3 mm.
15. A lancet assembly according to claim 14, wherein said blade is sheared along the entire length of said blade portion.
16. A lancet assembly according to claim 12, wherein said blade portion has anincluded angle less than 60°.
17. A lancet assembly according to claim 16, wherein said blade has a shear percentage of 100%.
18. A lancet assembly according to claim 12, wherein said blade portion has anincluded angle no larger than 45°.
19. A lancet assembly according to claim 12, wherein said blade width is no larger than 1 mm.
20. A lancet assembly according to claim 12, wherein said blade width is no larger than 0.60 mm.
CA002115197A 1993-02-26 1994-02-08 Lancet blade designed for reduced pain Expired - Fee Related CA2115197C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/023,496 US5395387A (en) 1993-02-26 1993-02-26 Lancet blade designed for reduced pain
US08/023,496 1993-02-26

Publications (2)

Publication Number Publication Date
CA2115197A1 CA2115197A1 (en) 1994-08-27
CA2115197C true CA2115197C (en) 1999-04-20

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA002115197A Expired - Fee Related CA2115197C (en) 1993-02-26 1994-02-08 Lancet blade designed for reduced pain

Country Status (6)

Country Link
US (1) US5395387A (en)
EP (1) EP0613656A3 (en)
JP (1) JP2602626B2 (en)
AU (1) AU673708B2 (en)
CA (1) CA2115197C (en)
MX (1) MX9401199A (en)

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JPH07303626A (en) 1995-11-21
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CA2115197A1 (en) 1994-08-27
AU673708B2 (en) 1996-11-21
US5395387A (en) 1995-03-07
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MX9401199A (en) 1994-08-31
EP0613656A3 (en) 1998-04-01

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