WO1999026538A1

WO1999026538A1 - Self-administered lancet delivery system

Info

Publication number: WO1999026538A1
Application number: PCT/AU1998/000961
Authority: WO
Inventors: Dale Robert Brakey
Original assignee: Medigate Manufacturing Pte Ltd.
Priority date: 1997-11-20
Filing date: 1998-11-20
Publication date: 1999-06-03
Also published as: AUPP046697A0; AU1219599A; EP1032306A1; EP1032306A4

Abstract

A blood sampling device (5) comprising a lancet delivery system consisting of a base member (8), a resiliently mounted recoiling arm member (10) angularly extending from and above one end of the base member (8) and having an apertured lancet locating means (15) at the outer end of the arm member (10), an aperture in the base member (8) in alignment with the apertured lancet locating means (15), a lancet (23) located within a moulded plastic holder (7) and adapted to be inserted and lockable in the locating means (15) allowing removal after use, a hinged sleeve member (12) located in the base member aperture and extending below the base member (8), an upstanding latch member (14) secured between the base member (8) and the sleeve member (12) and engaging an abutment (22) on the lower end of the lancet locating means (15) to hold the device in an operable setting, whereby pressure on the underside of the hinged sleeve member (12) hinges the latch member (14) out of engagement with the abutment (22) and swings the recoiling arm (10) and the lancet (23) downwards through the hinged sleeve member (12).

Description

TITLE : SELF-ADMINISTERED LANCET DELIVERY SYSTEM

FIELD OF THE INVENTION

This invention relates to a capillary blood sampling device.

BACKGROUND TO THE INVENTION

There is a need to take blood samples and this is commonly done by pricking a finger with a sterilised sharp lancet but this may involve substantial pain and/or apprehension in a subject whose blood is to be sampled such that self-administration or administration may be unpleasant. Prior Art

Various devices are known for sampling blood but Applicant considers many of them to have various disadvantages and many such disadvantages were overcome by Applicant's prior Patent Application No. 10101/95. However, Application No. 10101/95 is directed to a one-piece moulding of the delivery system including the needle requiring disposal of the total device after a single use which, to an extent, lessens the cost effectiveness of the device, although not its effectiveness in use.

It is an object of the present invention to provide a lancet delivery system of two-piece design whereby for home and personal use capillary blood sampling is now comfortable, convenient and cost effective whereby the lancet automatically penetrates to the required depth needed to obtain blood samples whilst reducing apprehension.

The present invention also offers important benefits including, the bubble up effect which enables unadulterated sampling, a recoiling arm to control accuracy, depth of penetration and reliability of sampling, and a pressure release mechanism to minimise pain.

The present invention also features a sterile needle, controlled delivery of lancet, enhanced design of needle tip to minimise pain, administration with one hand and a reusable delivery system.

SUMMARY OF THE INVENTION

The present invention provides a blood sampling device comprising a lancet delivery system comprising of a base member, a resiliently mounted recoiling arm member angularly extending from and above one end of the base member and having apertured lancet locating means at the outer end of the arm member, an aperture in the base member in alignment with said apertured lancet locating means, a lancet located within a moulded plastics material casing and adapted to be inserted and lockable in said locating means in a manner allowing removal therefrom after use, a hinged sleeve member located in said base member aperture and extending with respect to the base member, a latch member secured between the base member and said sleeve and operable to engage under an abutment on the lancet locating means to hold the device in an operable setting and whereby pressure on the said hinged sleeve member hinges the latch member out of engagement with said abutment and allows rapid movement of said recoiling arm and its lancet downwards through said hinged sleeve member.

PREFERRED ASPECTS OF THE INVENTION

Preferably an end of the hinged sleeve member is counterbored to provide a tapered lead- in to the sleeve which can in use cause the skin of a fmger tip or other part of the body to bulge up within the sleeve so as to bring the skin into proximity to the sharp end of the lancet.

Where the device is intended for use in pricking fingers, it is preferred that the internal diameter of the hinged sleeve is within the range of 0.35 to 0.70 cm and more preferably 0.50 to 0.60 cm.

The pointed end of the lancet is provided with a moulded removable cover which protects the user from accidental sticking during handling and maintains a piercing point in sterile condition, said removable cover being easily twisted off just before use.

The encased lancet is located in the lancet locating aperture through slots engageable by protrusions on the moulded encasement of the lancet which encasement is rotated out of engagement with the slots into a releasable locking position.

In order that the invention and its manner of performance may be more fully understood, reference will now be made to an embodiment of the invention as described with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWINGS

Figure 1 is a side elevation of a blood sampling device according to one form of the invention; Figure 2 is an end elevation taken in the direction of the arrow 2 of Figure 1;

Figure 3 is a plan view taken along the line 3-3 of Figure 1;

Figure 4 is a sectional view taken along the line 4-4 of Figure 3;

Figure 5 is a part-sectional view showing the lancet locked in position in its locating means; and

Figure 6 is an elevational view partly in section of the device cocked and ready for use.

INTEGER LIST

5. Capillary blood sampling device 6. Delivery system

7. Lancet holder

8. Base member

9. Serrations on base

10. Arm member 11. Base aperture

12. Sleeve member

13. Hinge

14. Latch member

15. Arm cylindrical part 16. Slots

17. Protrusions

18. Lower part of lancet holder

19. Sharp point of lancet

20. Weakened part 21. Lower end of cylindrical part

22. Abutment

23. Lancet DETAILED DESCRIPTION WITH RESPECT TO THE DRAWINGS

Referring to the embodiment of the drawings, the capillary blood sampling device is generally designated 5 and is preferably formed of moulded plastics material with the delivery system 6 thereof formed as a separate moulding, normally by injection moulding, from the lancet holder 7, also an injection moulding.

The delivery system 6 includes a base member 8 which is provided with serrations 9 acting as means to assist gripping of the system.

A recoiling arm member 10 is resiliency mounted at one end of base member 8 and extends over and above the base member 8 at an angle thereto, preferably 25° - 30°.

Towards the end of base member 8 remote from the mounting of arm member 10 there is formed an aperture 11 in which is hingedly located a sleeve member 12 and wherein the hinge consists of an integrally moulded flexible lower part 13 of an upstanding latch member 14. The sleeve member 12 preferably protrudes below the underside of the base member 8 to allow engagement therewith under pressure by a fmger or some other part of the body from which a sample is to be taken.

At the outer end of arm 10 there is located an apertured cylindrical part 15 adapted to releasably locate a lancet holder 7 in a locked condition. The cylindrical part 15 is provided internally with vertically extending slots 16 engageable by diametrically extending protrusions 17 on the lancet holder 7 whereby on full insertion of the holder 7 into cylindrical part 15 and through the end thereof, the holder 7 may be rotated when the protrusions 17 can just clear the cylindrical part 15 and engage under a non-slotted part of cylindrical part 15 under a frictional pressure grip.

The lower part 18 of lancet holder 8 covering the sharp point 19 of the lancet 23 is joined to the lancet holder 7 by a weakened part 20 whereby on twisting lower part 18 to break away said lower part 18, the end sharp point 19 is exposed ready for use as shown in Figure 6. The lower end 21 of cylindrical part 15 is provided on its outer surface with an abutment 22 engageable by the upper end of latch member 15 with arm member 10 lifted to a spring loaded position as shown in Figure 6.

Application of pressure on a user's finger on sleeve 12 whilst holding base member 8 will pivot sleeve 12 about hinge 13 and release latch member 14 from abutment 22 whereby the lancet sharp point 19 is driven down by tensioned arm 10 into engagement with the user's finger to the desired required depth of penetration and the arm 10 returns to its unloaded position with point 19 clear of the user's finger. The lancet holder 7 is then rotated to bring protrusions 17 into line with slots 16 and removed from cylindrical part 15 and then immediately discarded into a proper bio-hazard container. The delivery system 6 is now ready for loading with a new lancet holder.

It will be appreciated that there may be made many modifications in details of design and configuration of the sampling device of the invention as described in the above embodiment and all such modifications are deemed to be within the broad scope of the inventions.

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS :-

1. A blood sampling device comprising a lancet delivery system comprising of a base member, a resiliently mounted recoiling arm member angularly extending from and above one end of the base member and having apertured lancet locating means at the outer end of the arm member, an aperture in the base member in alignment with said apertured lancet locating means, a lancet located within a moulded plastics material casing and adapted to be inserted and lockable in said locating means in a manner allowing removal therefrom after use, a hinged sleeve member located in said base member aperture and extending with respect to the base member, a latch member secured between the base member and said sleeve and operable to engage under an abutment on the lancet locating means to hold the device in an operable setting and whereby pressure on the said hinged sleeve member hinges the latch member out of engagement with said abutment and allows rapid movement of said recoiling arm and its lancet downwards through said hinged sleeve member.

2. A system as claimed in Claim 1, wherein an end of the hinged sleeve member is counterbored to provide a tapered lead-in to the sleeve which can in use cause the skin of a finger tip or other part of the body to bulge up within the sleeve so as to bring the skin into proximity to the sharp end of the lancet.

3. A system as claimed in Claim 1, wherein the internal diameter of the hinged sleeve is within the range of 0.35 to 0.70 cm and more preferably 0.50 to 0.60 cm.

4. A system as claimed in Claim 1 , wherein the pointed end of the lancet is provided with a moulded removable cover which protects the user from accidental sticking during handling and maintains a piercing point in sterile condition, said removable cover being easily twisted off just before use.

5. A system as claimed in claim 1, wherein the encased lancet is located in the lancet locating aperture through slots engageable by protrusions on the moulded encasement of the lancet which encasement is rotated out of engagement with the slots into a releasable locking position.

6. The steps, features, compositions and compounds referred to or indicated in the specification and/or claims of this application, individually or collectively, and any and all combinations or any two or more of said steps or features.