Blood lancet device for withdrawing blood for diagnostic purposes

• US 5,554,166 A
• Filed: 06/16/1994
• Issued: 09/10/1996
• Est. Priority Date: 06/21/1993
• Status: Expired due to Term

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Argauer, Herbert, Lange, Hans
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/260,811
• Time in Patent Office: 817 Days
• Field of Search: 606/181-183, 128/770
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

Blood lancet device (1) for withdrawing blood from a patient for diagnostic purposes comprises a housing (10), a lancet holder (11) movable within the housing (10) for retaining a non-rotatable lancet (4) having a plastic lancet body (31), a lancet needle (33) fixed in the lancet body (31), a lancet drive (12) to move the lancet holder in a puncturing and retraction direction, an exchangeable skin-contact part (5) having an outlet opening (6) for the lancet (4) and a contact surface (42) for pressing against a patient'"'"'s skin. The skin-contact part (5) and lancet (4) form a unitary disposable item (3) which is intended for once-only use and is intended to be inserted at an anterior end (2) of the housing (10) in a single operation only as a unit with the skin-contact part (5) The skin-contact part (5) and the lancet body (31) are connected to one another through a first predetermined breaking section (52) to permit the skin-contact part (5) and the lance body (31) to be separable from one another following insertion of the disposable item (3). A second breaking section connects a protective needle cap to the lancet body and both breaking sections are severed by twisting of the protective cap.

Claims

1. Blood lancet device for withdrawing blood for diagnostic purposes, comprising:

a housing,

a lancet holder, movable within the housing, for holding a lancet, said lancet being a component of a disposable item which comprises the lancet with a lancet body made of a plastic material, an exchangeable skin contact part and a lancet needle fixed in the lancet body, and which disposable item is intended for once only use and is inserted at an anterior end of the housing in a single operation,

a lancet drive to drive the puncturing and retraction movement of the lancet holder with a lancet held therein,

wherein the housing has an anterior end in the puncturing direction, receiving the exchangeable skin-contact part and the lancet,

said exchangeable skin-contact part having a contact surface for pressing against the skin when using the blood lancet device and an outlet opening for the lancet,

wherein said disposable item is configured such that the lancet can be inserted only together with the skin-contact part, and

wherein the skin-contact part and lancet body are connected to one another and at the point of connection between the skin-contact part and the lancet body, a first predetermined breaking section is provided by means of which the skin-contact part and the lance body are separable from one another following insertion of the disposable item.

2. Blood lancet according to claim 1, wherein the lancet has a tip-protection cap made of a plastic material which is connected with the lancet body via a second predetermined breaking section, and

wherein both predetermined breaking sections are separated following insertion of the disposable item.

3. Blood lancet device according to claim 2, wherein the disposable item is configured such that the first predetermined breaking section and the second predetermined breaking section are separable in a single operation.

4. Blood lancet device according to claim 3 wherein, after insertion of the disposable item, the lancet holder holds the lancet non-rotatably and a rotation-limiting stop for the skin-contact part is provided at the anterior end of the housing, and wherein both predetermined breaking sections are separable by rotation of the tip-protection cap relative to the lancet and the skin-contact part.

5. Blood lancet device according to claim 2, wherein the tip-protection cap is connected with the skin-contact part at an edge of the outlet opening, and

wherein the first predetermined breaking section is provided at this connection.

6. Blood lancet device according to claim 5, wherein the skin-contact part is disposed in front of the lancet body in the puncturing direction, and the tip-protection cap extends through the outlet opening of the skin-contact part.

7. The blood lancet device according to claim 2, wherein separation of the breaking sections allows for removal of the tip-protection cap while at the same time allows for retention of the skin-contact part in the housing.

8. The blood lancet device according to claim 7, wherein the separation of the breaking sections causes removal of a central portion of the skin-contact part to provide a clear passageway through the outlet opening for passage of a sharp end portion of the needle during the puncturing operation.

9. Blood lancet device according to claim 1, wherein the skin-contact part is configured ring-shaped.

10. Blood lancet device according to claim 1, wherein the lancet drive has a tension spring and means for ensuring that repeated tensioning of the lancet drive is permitted only after removal of a lancet, which during the preceding puncturing and retraction movement was located in the lancet holder.

11. The blood lancet device of claim 1, wherein the lancet body is of such shape that it cannot be removed from the housing without removal of the skin contact part from the housing.

17. The disposable lancet device according to claim 6 wherein the first predetermined breaking section is provided between the tip-protection cap and the skin contact part.

12. A disposable blood lancet device for insertion into a lancet driver for use in withdrawing blood for diagnostic purposes,

said disposable lancet device comprising a lancet body made of a plastic material, an exchangeable skin contact part and a lancet needle fixed in the lancet body,

the exchangeable skin-contact part being attached to the lancet body, said exchangeable skin-contact part having a contact surface for pressing against the skin when using the disposable blood lancet device,

wherein the disposable lancet device is intended for once-only use and can be inserted into an anterior end of a lancet driver in a single handling operation,

wherein the skin-contact part and lancet body are connected to one another by a first predetermined breaking section by means of which the skin-contact part and the lancet body are separable from one another following insertion of the disposable item.

13. The disposable blood lancet device according to claim 12, having a tip-protection cap made of a plastic material which is connected with the lancet body via a second predetermined breaking section, and

wherein both predetermined breaking sections are configured for separation following insertion of the disposable lancet device into the lancet driver.

14. The disposable blood lancet device according to claim 13, which is configured such that the first predetermined breaking section and the second predetermined breaking section are separable in a single operation.

15. The disposable blood lancet device according to claim 14 wherein both predetermined breaking sections are separable by rotation of the tip-protection cap relative to the lancet body.

16. The disposable blood lancet device according to claim 12, having a tip-protection cap that is connected with the skin-contact part, and

wherein the first predetermined breaking section is provided at this connection.

18. The disposable blood lancet device according to claim 12, wherein the skin-contact part is configured ring-shaped surrounding an outlet opening for said needle.

19. The disposable blood lancet device according to claim 18, wherein the skin-contact part is disposed in front of the lancet body in the puncturing direction, and the tip-protection cap extends in front of the skin-contact part and through the outlet opening of the skin-contact part.

20. The disposal blood lancet device of claim 12 wherein the lancet needle has a sharp point and is fixed in the lancet body with its sharp point positioned posterior to the skin-contact part and wherein separation of the skin-contact part from the lancet body provides an opening through the skin-contact part for movement of the needle point therethrough during a skin puncturing operation.

21. A method for puncturing the skin of a patient for withdrawing blood for diagnostic purposes utilizing a lancet driver for driving a tip of a needle of a disposable lancet device into the patients skin comprising;

inserting a disposable lancet device comprising a lancet body a lancet needle fixed in the lancet body, and an exchangeable skin-contact part as a unit into an anterior end of a housing of the lancet driver with the lancet body and needle being located within said housing of the said lancet drive and with a surface of the skin-contact part extending outwardly of the lancet driver housing,

breaking a breaking section connecting the lancet body and the skin-contact part to disconnect the skin-contact part form the lancet body without removing the skin-contact part from being held by the housing,

placing the outward surface of the skin-contact part against the skin of the patient without removing the skin contact part from being held by the housing;

actuating the lancet driver to cause the lancet body to move toward the anterior end of the lancet driver housing and relative to the skin-contact part wherein a tip of the needle fixed in the lancet body passes through the skin-contact part and into the patients skin.

22. The puncturing method of claim 21 wherein the disposable lancet device inserted into the housing of the lancet driver is provided with a needle tip protecting cap that covers the tip of the needle and is unitary with the disposable lancet device, and wherein the needle tip protecting cap is removed and separated from the disposable lancet device prior to the placement of the outward surface of the skin-contact part against the skin of the patient.

23. The puncturing method of claim 22 wherein the breaking of the breaking section connecting the skin-contact part from the lancet body occurs simultaneously with the separation of the needle tip protector cap.

24. The puncturing method of claim 23 wherein the needle tip protector is separated from the skin-contact part by rotation of the needle tip protector relative to the skin-contact part.

25. The puncturing method of claim 24 wherein the holding of the disposable lancet by the driver housing after insertion prevents rotation of the skin-contact part and the lancet body without preventing rotation of the needle tip protector.

26. The puncturing method of claim 21 wherein the lancet body is expelled from the housing after puncturing and wherein during this expulsion the lancet body abuts the skin-contact part and also causes the skin-contact part to be expelled from the housing.