Lancet device for puncturing the skin

• US 20070244498A1
• Filed: 09/01/2006
• Published: 10/18/2007
• Est. Priority Date: 04/13/2006
• Status: Active Grant

• Current Assignee: HTL-STREFA S.A. (Medical Technology Solutions LLC)
• Original Assignee: HaeMedic AB (Medical Technology Solutions LLC)
• Inventors: Steg, Henning
• Granted Patent: US 7,811,302 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• 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 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A lancet device for puncturing the skin of mammals, in particular of a human, includes a punch element, a manipulator, and a bushing element for the internal, axially displaceable reception of the punch element. The punch element on its free end has a lancet, provided with a sharp tip, for intentionally entering the skin. The lancet, by means of a force acting in the axial direction on the free end of the bushing via the punch element can be made to enter the skin from the end of the bushing outward with a preadjustable momentum, and a blocking arrangement using an axially slidable sleeve inside the bushing is provided, which, once the lancet has entered the skin, prevents the possibility of a reentry by locking itself within the bushing.

Claims

1. A lancet device (10) for puncturing the skin (11) of mammals such as a human, comprising a punch element (12), a manipulator (13) operably connected to the punch element, and a bushing element (14), having a grip (15) and an interior (28) in which the punch element (12) is disposed in axially displaceable relationship, the punch element (12) on its free end (17) pointing away from the manipulator (13) having a lancet (18) provided with a sharp tip (19) for deliberate entering of the skin (11), and wherein the lancet (18), via the punch element (12), by means of a force acting in the axial (16) direction can be made to enter the skin (11) from the free end (21) of the bushing outward with a preadjustable momentum;

and including blocking means which, once the lancet (18) has entered the skin (11), prevents the possibility of reentry;

said blocking means comprising a sleeve element (35) disposed in the interior (28) of the bushing element (14) in axially slidable relationship, and which includes a first sleeve projection (38), pointing toward the axis (16), past which first sleeve projection a first punch projection (24) on the punch element, pointing away from the axis (16), in the course of the entry of the lancet (18) into the skin (11), is slidingly displaceable in such a way that it engages the first sleeve projection (36) axially from behind, and in the course of the reentry of the lancet (18) into the end (21) of the bushing displaces the sleeve element (35) axially (16) in the direction of the manipulator (13).

2. The lancet device as defined by claim 1, wherein the sleeve element (35), on its end (37) opposite the first projection (38), has a shoulder (36), which after the conclusion of the axial displacement in the direction of the manipulator (13) engages a bushing shoulder (25), formed on the bushing element (14), from behind.

3. The lancet device as defined by claim 2, wherein the sleeve element (35), at least in the region of its shoulder (36), is prestressed radially away from the axis (16).

4. The lancet device as defined by claim 1, wherein the punch element (12), on a free end (17) thereof, has a cap element (29) which in sterile fashion sheathes a lancet tip (19) protruding from the punch element at that end.

5. The lancet device as defined by claim 4, wherein the punch element (12) and the cap element (29) are formed as a one-piece molded part.

6. The lancet device as defined by claim 1, wherein the punch element, in the region of the connection with the cap element (29), is provided with a weakened breaking zone (31).

7. The lancet device as defined by claim 6, wherein the weakened breaking zone (31) is formed by a radial tapering of the connection region (30).

8. The lancet device as defined by claim 4, wherein the cap element (29), on its end (39) that in the untripped state of the lancet device (10) is positioned in the bushing element (14), has at least two locking ribs (40, 41), protruding generally radially from the cap element (29), which in the untripped state of the lancet device (10), upon actuation of the manipulator (13) in the axial (16) direction (34), strike an abutment (42) formed in the region of the free end (21) of the bushing element (14).

9. The lancet device as defined by claim 8, wherein upon rotation of the cap element (29) about an axis (16) by an angle α

, the locking ribs (40, 41) are located facing an abutment-free portion (43) in the region of the free end (21) of the bushing element (14).

10. The lancet device as defined by claim 9, wherein upon rotation of the cap element (29) about an axis (16) by an angle α

, the integral connection between the cap element (29) and the punch element (12) is broken, and the cap element (29) is removable from out of the bushing element (14).

11. The lancet device as defined by claim 1, wherein the punch element (12) has a second punch projection (26), which points away from the axis (16) and is located downstream, in terms of the exit direction (34) of the lancet (18), from the first punch projection (24) and spaced apart axially from the first punch projection, and which, by coming into contact with a first shoulder (27) of the bushing element (14), limits the axial (16) displacement travel of the lancet (18) into the bushing element (14) counter to the exit direction (34).

12. The lancet device as defined by claim 1, wherein the manipulator (13) of the punch element (12) is formed at least partially as a resilient spring body in the form of a diaphragm (20), which causes the lancet (18), via the punch element (12) after an adjustable pressure point of the diaphragm has been overcome, to enter the skin (11) with a predeterminable momentum.

13. The lancet device as defined by claim 12, wherein the diaphragm (20) is formed as a substantially disc-like body, which is curved in upwardly convex fashion in cross section.

14. The lancet device as defined by claim 12, wherein the diaphragm (20) and the shaftlike punch element (12) are formed integrally as one piece.

15. The lancet device as defined by claim 1, wherein the grip (15) of the bushing element (14) and the manipulator (13) of the punch element (12) each have a substantially disc-like structure and are connectable to each another in the course of the connection of the manipulator (13) and grip (15) via mutual engagement means (44, 45) provided on each of them.

16. The lancet device as defined by claim 15, wherein the engagement means (44) on the grip (15) of the bushing element (14) is formed as a substantially peripheral groove, and the engagement means (45) on the manipulator (13) of the punch element (12) is formed as a substantially peripheral spring, and for connecting the two manipulator and grip (13, 15), the spring engages the groove.

17. The lancet device as defined by claim 1, wherein the connection of the manipulator (13) and grip (15) has a radial play.

18. The lancet device as defined by claim 1, wherein the punch element (12), the bushing element (14), and the sleeve element (35) comprise plastic material.