Adjustable Lancing Devices and Methods

• US 20080027474A1
• Filed: 05/30/2007
• Published: 01/31/2008
• Est. Priority Date: 06/15/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated), Facet Technologies LLC
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wyler, Jonathan, Curry, Samuel, Shur, Maiya, Vizcarra, Damien, Young, Kevin, Trissel, John, Lathrop, Ray, Flynn, Stephen
• Granted Patent: US 7,914,547 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150519 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 5/150648 fully automatically triggered, i.e. the triggering of the protective sleeve does not require a deliberate action by the user such as terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• 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

Lancing devices and methods of use are provided. Also provided are lancets for use with lancing devices. Certain embodiments of the lancing devices include a front end cap with an annular skin-engaging surface surrounding a piercing aperture.

Claims

1. A lancing device, comprising:

a housing having a skin-engaging end that defines a piercing aperture;

a user-actuated assembly operative to adjust an effective size of the piercing aperture between a first diameter configured to allow a user'"'"'s skin to pucker into the piercing aperture, and a second diameter that is smaller than the first diameter; and

a lancet assembly comprising a removable lancet with a sharp tip, disposed in the housing and configured to momentarily project and retract the sharp tip through the piercing aperture when the effective size of the piercing aperture is adjusted to one of the first diameter and the second diameter to permit the sharp tip to incise the user'"'"'s puckered skin.

2. The lancing device of claim 1, further comprising at least one indicia corresponding to an alternate site incision mode, wherein the user-actuated assembly is operative to adjust the effective size of the piercing aperture to the first diameter when a portion of the user-actuated assembly is positioned in visual association with the indicia.

3. The lancing device of claim 1, wherein the user-actuated assembly further comprises a sleeve with a secondary aperture defining the second diameter, the sleeve movable between at least a rearward and a forward position to adjust the effective size of the piercing aperture between the first and second diameters, respectively;

and where the sleeve in the rearward position is configured so that the user'"'"'s puckered skin is not flattened during incision.

4. The lancing device of claim 3, wherein the sleeve in its rearward position is sufficiently spaced apart from the piercing aperture to permit skin to pucker through the piercing aperture during lancing.

5. The lancing device of claim 3, wherein the sleeve in the forward position is interposed within the piercing aperture to adjust the effective size of the piercing aperture to the second diameter during lancing, and wherein the user-actuated assembly is configured to move the sleeve independently of the lancing assembly and to retain the sleeve in the forward position when the sharp tip is retracted through the piercing aperture.

6. The lancing device of claim 3, wherein the removable lancet further comprises an elongated body in which the sharp tip is disposed and the sleeve is slidably and coaxially mounted to the elongated body;

and wherein the user-actuated assembly is configured to move the sleeve to the forward and rearward positions independently of the elongated body.

7. The lancing device of claim 6, wherein the sleeve is configured to remain stationary relative to the housing when the sharp tip is projected and retracted.

8. The lancing device of claim 3, further comprising an ejector adapted to remove the lancet from the lancet assembly, wherein the sleeve remains mounted to the lancet assembly when the lancet is so removed.

9. A lancing device, comprising:

a housing having a user-engaging end that defines a piercing aperture therethrough;

a lancet disposed in the housing and having a needle terminating in a sharp tip and a sleeve disposed about at least a portion of the needle and moveable relative to the housing and the needle;

a user-controlled actuator operative to selectively move the sleeve, independently of the needle, between at least a forward position in which the sleeve obstructs a portion of the piercing aperture and a rearward position in which the sleeve is withdrawn from the piercing aperture, the rearward position configured to permit a user'"'"'s skin to extend through the piercing aperture during incision.

10. The lancing device of claim 9, further comprising at least one indicia corresponding to an alternate site incision mode, wherein the user-controlled actuator is operative to move the sleeve to the rearward position when a portion of the user-controlled actuator is positioned in visual association with the indicia.

11. The lancing device of claim 9, wherein the sleeve in the rearward position is sufficiently spaced apart from the piercing aperture so that the sleeve does not flatten the user'"'"'s skin.

12. The lancing device of claim 9, wherein the sleeve defines a secondary aperture through which the sharp tip projects.

13. The lancing device of claim 9, further comprising a drive mechanism configured to project and retract the sharp tip through the piercing aperture to incise a user'"'"'s skin, and wherein the user-controlled actuator is configured so that the sleeve remains stationary relative to a skin-engaging surface when the sharp tip is retracted.

14. The lancing device of claim 9, wherein the needle is fixed in relation to the housing when the user-controlled actuator moves the sleeve.

15. The lancing device of claim 9, further comprising a drive mechanism configured to project and retract the sharp tip through the piercing aperture, wherein the user-controlled actuator is configured to engage the sleeve with the user'"'"'s skin during incision when the sleeve is in the forward position, and the sleeve remains stationary relative to a skin-engaging surface of the piercing aperture when the sharp tip is retracted.

16. The lancing device of claim 15, wherein the piercing aperture defines a compression ring at the skin-engaging surface;

wherein a front end of the sleeve lies substantially planar with the compression ring when the user-controlled actuator moves the sleeve to the forward position.

17. The lancing device of claim 9, wherein the piercing aperture is between about 5 millimeters and about 15 millimeters in diameter.

18. The lancing device of claim 9, wherein the user-controlled actuator further comprises:

a receiver disposed within the housing for axial movement relative to the piercing aperture, the receiver adapted to engage the sleeve; and

a switch coupled to the receiver and selectively movable by a user in at least a first direction and a second direction;

wherein the receiver is configured to move the sleeve to the forward position in response to the switch being moved by the user in the first direction, and to move the sleeve to the rearward position in response to the switch being moved by the user in the second direction.

19. The lancing device of claim 18, wherein the switch comprises a finger extending through a slot in the housing, wherein the finger engages the receiver to axially move the receiver in response to a user'"'"'s translational movement of the finger.

20. The lancing device of claim 18, wherein the switch comprises a cam rotatably mounted to the housing, wherein one of the cam and the receiver further comprises a boss and the other of the cam and the receiver further comprises a cam trail in which the boss is engaged;

and wherein rotation of the cam by the user in the first and second directions drives the receiver in a corresponding axial movement.

21. The lancing device of claim 18, wherein the receiver comprises a receiver body having a front end and a rear end and a bore extending between the front end and the rear end;

and wherein at least a portion of the lancet is disposed within the bore.

22. The lancing device of claim 21, wherein the receiver further comprises at least a first engagement portion adapted to mate with a corresponding second engagement portion located on the sleeve to secure the sleeve to the receiver.

23. The lancing device of claim 22, wherein the first and second engagement portions form a clasp.

24. The lancing device of claim 18, wherein the receiver includes a receiver body having a front end and a rear end and a bore extending between the front end and the rear end;

wherein at least a portion of the sleeve is disposed within the bore and a diameter of the bore is sized to hold the sleeve therein with a friction fit.

25. The lancing device of claim 9 wherein the user-controlled actuator is located intermediate to the user-engaging end of the housing and a rear end of the lancet.

26. A lancing device for use with a lancet, the lancet having a needle terminating in a sharp tip for incision in a user'"'"'s skin and a sleeve disposed about at least a portion of the needle and movable relative to the needle, comprising:

a housing having a user-engaging end that defines a piercing aperture therethrough;

an actuator having a control member accessible by a user outside the housing and a sleeve-engagement portion operatively coupled to the control member and disposed within the housing;

the sleeve-engagement portion responsive to movement of the control member to engage the sleeve in one of a forward position and a rearward position when the lancet is inserted into the housing;

wherein the forward position is sufficiently close to the piercing aperture so that the sleeve is interposed within the piercing aperture during incision; and

wherein the rearward position is sufficiently spaced apart from the piercing aperture, the rearward position configured to permit skin to pucker through the piercing aperture during incision; and

a lancet engagement mechanism within the housing adapted to engage the lancet needle at a position independent of the position that the sleeve-engagement portion engages the sleeve.

27. The lancing device of claim 26, wherein the control member is movable by the user between a first position corresponding to incision at an alternative site and a second position corresponding to incision at a finger, wherein the actuator is configured to move the sleeve-engagement portion to the rearward position when the control member is moved to the first position.

28. The lancing device of claim 26, wherein the actuator is configured to move the sleeve-engagement portion independently of the lancet engagement mechanism.

29. The lancing device of claim 26, wherein the lancet engagement mechanism is adapted to move forward and rearward during incision, and wherein the actuator is configured so that the sleeve-engagement portion remains stationary relative to the user-engaging end of the housing when the lancet engaging mechanism moves forward and rearward during incision.

30. A method for using a lancing device having a skin-engaging surface that defines a piercing aperture therethrough, comprising:

positioning inside the lancing device a lancet having a needle terminating in a sharp tip;

setting an effective size of the piercing aperture to one of a first diameter configured to allow a user'"'"'s skin to pucker into the piercing aperture and a second diameter that is smaller than the first diameter; and

incising the user'"'"'s skin with the lancet while the effective size of the piercing aperture is set at one of the first diameter and the second diameter.

31. The method of claim 30, wherein setting the effective size of the piercing aperture comprises moving a control member relative to the piercing aperture so that the control member is in one of a forward position and a rearward position relative to the piercing aperture, wherein the control member is sufficiently spaced apart from the piercing aperture in the rearward position to permit the user'"'"'s skin to pucker through the piercing aperture during incision.

32. The method of claim 31, wherein the control member in the rearward position is sufficiently spaced apart from the piercing aperture so as to not flatten the user'"'"'s skin during incision.

33. The method of claim 31, wherein the control member is a sleeve coaxially mounted to the needle in sliding engagement, and wherein setting the effective size of the piercing aperture comprises holding the needle stationary relative to the piercing aperture while moving the sleeve.

34. The method of claim 31, wherein incision the user'"'"'s skin further comprises extending and retracting the sharp tip of the needle through the piercing aperture while holding the control member stationary relative to the piercing aperture.

35. The method of claim 30, further comprising providing a control member that is accessible to a user outside a housing of the lancing device, the control member having at least a first user-selectable position associated with an alternate site incision, wherein setting the effective size of the piercing aperture is responsive to user actuation of the control member to set the effective size to the first diameter when the control member is in the first user-selectable position configured to allow the user'"'"'s skin to pucker into the piercing aperture during incision at an alternate site.