WO1997046157A1 - Adjustable tip lancet - Google Patents
Adjustable tip lancet Download PDFInfo
- Publication number
- WO1997046157A1 WO1997046157A1 PCT/US1997/006491 US9706491W WO9746157A1 WO 1997046157 A1 WO1997046157 A1 WO 1997046157A1 US 9706491 W US9706491 W US 9706491W WO 9746157 A1 WO9746157 A1 WO 9746157A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sleeve
- inner sleeve
- lancet
- distal end
- needle
- Prior art date
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
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
-
- 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
- A61B5/150175—Adjustment of penetration depth
- A61B5/150183—Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
-
- 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
-
- 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
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
-
- 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
Definitions
- the present invention relates in general to a blood lancet device for obtaining a drop of blood for testing.
- the present invention provides an adjustable tip for a blood lancet device which allows for several different depths of skin puncture.
- a prior art adjustable tip device is presently manufactured by the Boehringer Mannheim Company.
- the "Softclix” tip can be termed a “single bottom” device because that area of the tip which rests against the skin is but a single layer of plastic.
- the end of the tip is threaded and skin puncture depth is adjusted by merely rotating the tip clockwise or counterclockwise.
- This straightforward method of depth adjustment is possible because Boehringer uses a custom lancet which is notched to fit precisely in the lancet carrier. Therefore, the lancet travels exactly the same distance each time that the Boehringer device is fired.
- the most commonly used lancet does not avail itself of this simple solution to varying the depth of skin puncture.
- the generic lancet has no notch that would allow it to be positioned in exactly the same way each time it is loaded into the lancet carrier. A different method must therefore be used to reliably vary the depth of strike.
- the prior art also includes the adjustable tip lancet mechanism of the Bodicky et al U.S. patent 4,895,147 dated January 23, 1990. That patent teaches a relatively complex "single bottom” tip that includes a mechanism for applying a vacuum to the puncture site.
- the prior art also includes the Slama U.S. patent 4,469,110 dated September 4, 1984.
- the Sla a device adjusts penetration depth by rotating the threaded sleeve 10 relative to the body 2.
- the Slama device is a "single bottom” device using relatively expensive threads to achieve adjustable depth penetration.
- the patent does not teach a "double bottom” and does not teach means for holding the parts in position to achieve a given depth repeatedly.
- the technique herein described uses a "double bottom” tip in which the shoulder of the lancet provides the stop to the lancet's movement when it abuts against the "inner bottom.”
- the position of the "outer bottom” can be varied by the user by turning it against a helical camming surface. Molding of the helical groove is facilitated by placing the upper and lower surfaces of the groove in separate plastic parts which are then pressed together.
- the present design addresses these issues while keeping the cost to a minimum since only three parts are needed to make the tip.
- the design also preferably allows the tip to be made sufficiently small in diameter so that it matches the barrel size of commonly used pen-like devices. The entire device taken together is therefore aesthetically pleasing.
- One aspect of the invention is to provide an adjustable tip for a blood lancet device capable of use with the most commonly used lancet presently available.
- a further aspect of the invention is to provide an adjustable tip for a blood lancet device which is simple in design and relatively inexpensive to manufacture by using only three parts.
- Fig. 1 is a perspective view of the adjustable tip of the present invention mounted on a base which is currently com ⁇ surgeally available;
- Fig. 2 is a perspective view of the device shown in Fig. 1 wherein the base portion is retracted to the position shown in Fig. 2 to compress an internal spring to prepare the device for making a strike;
- Fig. 3 shows the device of Figs. 1 and 2 as a strike is being made
- Fig. 4 is a perspective and exploded view of the adjustable tip of the present invention relative to a commercially available base on which the tip is mounted;
- Fig. 5 is a perspective and partially exploded view of the adjustable tip according to the present invention.
- Fig. 6 is an elevational view of the most common and readily available lancet
- Fig. 7 is a sectional view of the adjustable tip as adjusted for maximum penetration
- Fig. 8 is a sectional view of the adjustable tip of the present invention as adjusted for minimum penetration
- Fig. 9 is a section on the line 9-9 of Fig. 8;
- Fig. 10 is a sectional and exploded view of the adjustable tip of the present invention.
- Figs. 1, 2 and 3 show the adjustable tip lancet of the present invention as 20 mounted on a base member which includes collar 12 attached to a fixed tubular member 11.
- a ⁇ lidable outer tube 10 is movable in the direction of the arrows shown in Figs. 2 and 3 to compress an internal spring to prepare the lancet for a strike.
- the present invention relates to the adjustable tip 20 of Figs. 1-3.
- the base of the instrument is essentially the same as shown in Levin et al U.S. patent Re. 32,922 dated May 16, 1989, incorporated herein by reference.
- the inside workings contained within fixed tube 11 and collar 12 are shown in detail in patent Re. 32,922 and are not repeated here.
- the point 72 of the lancet needle is driven past the distal end 64 of the adjustable tip 20.
- the depth of the strike is readily adjustable as described in further detail below.
- the user presses the distal surface 64 against the surface of a finger, for example, and depresses trigger 13 which releases a compressed spring carried internally which in turn causes the needle point 72 to puncture the skin.
- Fig. 4 shows an exploded view of the adjustable tip 20 which consists of three parts. Those parts include an inner sleeve, shown generally as 30, an intermediate cylindrical ring, shown generally as 50, and an outer cylindrical sleeve, shown generally as 60.
- the inner sleeve is carried by the base of the device shown partially in Fig. 4.
- the external threads 16 carried by the instrument base receive internal threads 39 of inner sleeve 30, as shown best in Figs. 7 and 8.
- An internal plunger 15 carried by the base member is driven by an internal compressed spring (not shown) carried in the base and advances in the vertical direction shown in Fig. 4 when the trigger 13 is pressed by the user.
- Inner sleeve 30 has a generally cylindrical shape center portion 35 having a proximal end 33 (Fig. 10) and distal end 37. Distal end 37 is partially enclosed to form a first surface against which the shoulder 74 of lancet 70 (Fig. 6) stops.
- the lancet includes an elongated body 71, typically of plastic material, and an elongated needle 73 carried within the body 71. Needle 73 has a longitudinal axis extending along its length. A generally planar shoulder 74 perpendicular to said longitudinal axis forms one end of body 71 of the lancet. Needle 73 extends through shoulder 74 and a tapered point 72 is formed on the end of needle 73. As shown best in Figs. 7 and 8, lancet 70 is carried inside inner sleeve 30 and is driven to the left in Figs. 7 and 8 along said longitudinal axis when trigger 13 is depressed. As shown best in Fig.
- an intermediate cylindrical ring 50 has a proximal end 54 and a distal end 53.
- Distal end 53 extends approximately 180°, as shown best in Fig. 4, and preferably forms a helical incline camming surface, shown best in Fig. 10.
- the camming surface 53 may also be non-helical, but a helical design is preferred.
- Intermediate cylindrical ring 50 also has two vertical surfaces 58 and 59 extending downwardly from its distal end 53. The purpose of vertical surfaces 58 and 59 is to mate with vertical surfaces 80 and 81 of outer cylin- drical sleeve 60 so that ring 50 and outer sleeve 60 rotate together in the assembled tip, as described below.
- Intermediate cylindrical ring 50 also has a plurality of vertically extending grooves formed in the interior surface of ring 50.
- the grooves 55 engage lug or detent 40 carried by inner sleeve 30, as shown best in Fig. 5.
- detent 40 seats in one of the grooves 55 corresponding to one of the five depth indicators 66 of outer sleeve 60 (Fig. 4) .
- Intermediate cylindrical ring 50 is adapted to slide onto inner sleeve 30 to the position shown in Fig. 5 and to rotate relative to inner sleeve 30.
- Outer cylindrical sleeve 60 is adapted to slide over and to be press fitted onto the intermediate ring 50, as shown schematically in Fig. 5.
- the preferred method of assembly is to press together sleeve 60 and ring 50, and then slide the two joined together over sleeve 30. Thereafter 50 and 60, mated together, rotate as a unit relative to inner sleeve 30.
- the upper and lower surfaces of the helix now form a complete helical groove which can capture a cam.
- Camming surfaces formed therein extend through an arc of approximately 180°.
- the outer sleeve 67 (Fig. 10) has a proximal end 62 and distal end 64.
- the distal end 64 is partially enclosed and has a circular opening 65 formed therein through which the point of the needle passes when a strike is made.
- First and second camming surfaces may be non-helical, but a helical design is preferred.
- FIG. 30 is used as a reference point to indicate which strike depth is set. As shown in Fig. 4, five strike depths are provided. Reference numerals 66 are applied to the outer surface of sleeve 60 in positions corresponding to grooves 55 in ring 50.
- the strike depth of the needle point 72 is adjusted by varying the longitudinal or axial distance between the distal end 64 of the outer sleeve 60 relative to the distal end 37 of the inner sleeve 30. Distal ends 64 and 37 form the "double bottom" aspect of the invention referred to above.
- Fig. 7 shows the maximum strike depth of the needle point 72 which is achieved when the distal end 37 of inner sleeve and distal end 64 of outer sleeve are adjacent each other. The position shown in Fig. 7 is achieved by rotation of the outer sleeve 60 in the clockwise direction as shown in Figs.
- Outer sleeve 60 has a tapered upper portion 63 which has a plurality of grooves formed therein to facilitate rotation of sleeve 60 by the user.
- Inner sleeve 30 has a pair of opposed indents or depressions 32 formed therein which allows the user to grasp the base of inner sleeve 30 between a thumb and index finger of one hand and to rotate the outer sleeve 60 with the other hand.
- Reference marker arrow 34 is positioned between the opposed indents 32 to maximize visibility of the depth indicator numerals 66 which include the numerals "1" through “5.”
- Fig. 9 shows the location of five grooves 55 formed in the inner wall of intermediate cylindrical ring 50. Each of these grooves is located approximately 45° from each other. The maximum rotation of the outer sleeve relative to the inner sleeve is approximately 180°.
- Each of the three parts comprising the adjustable tip i.e. the inner sleeve 30, the intermediate ring 50 and the outer sleeve 60, may be injection molded, and assembled by an inexpen- sive press fit, thereby minimizing the overall manufacturing costs.
- the simplicity of the design maximizes the useful life of the device.
- Cam follower 41 and detent 40 are resiliently carried on the outer surface of sleeve 30 by forming slits 42,43 and slits 44,45, respectively, in sleeve 30 adjacent thereto.
- Cam follower 41 has a rectangular cross-section for strength, as shown best in Fig. 10.
- the upper and lower surfaces of follower 41 are inclined to be parallel with camming surfaces 53 and 68 so that follower 41 moves smoothly against those surfaces.
- the preferred method of assembly is to initially press together the intermediate ring 50 and outer sleeve 60. When pressed together (or attached by adhesive or even sonic welding as less preferable alternatives) , ring 50 and sleeve 60 form a single part which has a smooth, interior groove formed by camming surfaces 53 and 68.
- Cam follower means 41 is resiliently carried by the outer surface of inner sleeve 30, allowing the single part thus formed to slide over it.
- Cam follower means 41 is "captured” by the groove formed by camming surfaces 53 and 68. Relative rotation of outer sleeve 60 with respect to inner sleeve 30 causes longitudinal motion of outer sleeve 60, as discussed above.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU26758/97A AU2675897A (en) | 1996-06-04 | 1997-04-15 | Adjustable tip lancet |
DE19781810T DE19781810T1 (en) | 1996-06-04 | 1997-04-15 | Adjustable tip for a lancing device |
JP9531230A JP2815706B2 (en) | 1996-06-04 | 1997-04-15 | Adjustable lancet tip |
HU9900335A HU220178B (en) | 1996-06-04 | 1997-04-15 | Adjustable tip lancet |
DE19781810A DE19781810C2 (en) | 1996-06-04 | 1997-04-15 | Adjustable tip for a lancing device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/659,056 US5613978A (en) | 1996-06-04 | 1996-06-04 | Adjustable tip for lancet device |
US08/659,056 | 1996-06-04 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1997046157A1 true WO1997046157A1 (en) | 1997-12-11 |
Family
ID=24643852
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/006491 WO1997046157A1 (en) | 1996-06-04 | 1997-04-15 | Adjustable tip lancet |
Country Status (6)
Country | Link |
---|---|
US (1) | US5613978A (en) |
JP (1) | JP2815706B2 (en) |
AU (1) | AU2675897A (en) |
DE (2) | DE19781810T1 (en) |
HU (1) | HU220178B (en) |
WO (1) | WO1997046157A1 (en) |
Cited By (15)
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WO2003037185A1 (en) | 2001-10-31 | 2003-05-08 | Arkray, Inc. | Sting device |
EP1405595A1 (en) † | 2001-07-11 | 2004-04-07 | ARKRAY, Inc. | Piercing device |
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WO2010086380A1 (en) | 2009-01-30 | 2010-08-05 | Pronota N.V. | Biomarker for diagnosis, prediction and/or prognosis of acute heart failure and uses thereof |
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Also Published As
Publication number | Publication date |
---|---|
HU220178B (en) | 2001-11-28 |
HUP9900335A2 (en) | 1999-05-28 |
DE19781810T1 (en) | 1999-05-27 |
JP2815706B2 (en) | 1998-10-27 |
HUP9900335A3 (en) | 1999-11-29 |
DE19781810C2 (en) | 2003-10-16 |
AU2675897A (en) | 1998-01-05 |
JPH10508527A (en) | 1998-08-25 |
US5613978A (en) | 1997-03-25 |
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