Adjustable lancing devices and methods

• US 7,914,547 B2
• Filed: 05/30/2007
• Issued: 03/29/2011
• 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), Facet Technologies LLC
• Inventors: Shur, Maiya, Vizcarra, Damien, Wyler, Jonathan M., Young, Kevin, Lathrop, Ray Adams, Trissel, John Andrew, Curry, Samuel Mason, Flynn, Stephen J.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US11/755,675
• Publication Number:
  US 20080027474A1
• Time in Patent Office: 1,399 Days
• Field of Search: 606/181, 606/182, 606/184, 606/185, 600/583, 604/110, 604/192, 604/196, 604/197, 604/198
• 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 user-engaging end that defines a piercing aperture therethrough;

a lancet having a needle terminating in a sharp tip, a body from which the needle extends and a sleeve directly coupled to the body and moveable relative to the needle when the lancet is in the housing, wherein the sleeve is in a locked position encasing the sharp tip of the needle when the lancet is external to the housing; and

a user-controlled actuator operative to hold the sleeve stationary, independently of the needle, when the lancet is disposed within the housing, in at least a forward position in which the sleeve obstructs a portion of the piercing aperture before, during and after the sharp tip projects from within the housing to external the housing and a rearward position in which the sleeve is a spaced distance from the piercing aperture before, during and after the sharp tip projects from within the housing to external the housing.

2. The lancing device of claim 1, wherein the user-controlled actuator is configured to move the sleeve to the forward and rearward positions independently of the body.

3. The lancing device of claim 1, further comprising an ejector adapted to remove the lancet from the housing, wherein the sleeve is moved to the locked position when the lancet is so removed.

4. The lancing device of claim 1, further comprising at least one indicia corresponding to an alternate site incision mode, wherein the user-controlled actuator is operative to hold the sleeve in the rearward position when a portion of the user-controlled actuator is positioned in visual association with the indicia.

5. The lancing device of claim 1, 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.

6. The lancing device of claim 1, wherein the sleeve defines a secondary aperture through which the sharp tip projects.

7. The lancing device of claim 1, 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 stationery relative to a skin-engaging surface before, during and after the sharp tip is retracted.

8. The lancing device of claim 1, wherein the needle is fixed in relation to the housing when the user-controlled actuator moves the sleeve.

9. The lancing device of claim 1, 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 when the sharp tip projects from within the housing to external the housing when the sleeve is in the forward position, and the sleeve remains engaged with the user'"'"'s skin and stationery relative to the piercing aperture when the sharp tip is retracted within the housing.

10. The lancing device of claim 9, 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.

11. The lancing device of claim 1, wherein the piercing aperture is between about 5 millimeters and about 15 millimeters in diameter.

12. The lancing device of claim 1, 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 when the lancet is inserted into the housing;

wherein the receiver is directly coupled to the user-controlled actuator such that the receiver is configured to move the sleeve to the forward position in response to the user-controlled actuator being moved by the user in a first direction, and to move the sleeve to the rearward position in response to the user-controlled actuator being moved by the user in a second direction.

13. The lancing device of claim 12, wherein the user-controlled actuator comprises a finger extending through a slot in the housing, wherein the finger directly engages the receiver to axially move the receiver in response to a user'"'"'s translational movement of the finger.

14. The lancing device of claim 12, wherein the user-controlled actuator 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.

15. The lancing device of claim 12, 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 contacts the receiver within the bore.

16. The lancing device of claim 15, 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.

17. The lancing device of claim 16, wherein the first and second engagement portions form a clasp.

18. The lancing device of claim 12, 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 contacts the receiver within the bore and a diameter of the bore is sized to hold the sleeve therein with a friction fit.

19. The lancing device of claim 1 wherein the user-controlled actuator is located intermediate to the user-engaging end of the housing and a rear end of the lancet.

20. A lancing device comprising:

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

a lancet having a needle terminating in a sharp tip for incision in a user'"'"'s skin, a body from which the needle extends and a sleeve directly coupled to the body and movable relative to the body when the lancet is in the housing, wherein the sleeve is in a locked position encasing the sharp tip of the needle when the lancet is external to the housing;

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 directly engage the sleeve when the lancet is within the housing and move the sleeve to one of a forward position and a rearward position, the rearward position holding the sleeve a spaced distance from the piercing aperture and the forward position holding the sleeve within the piercing aperture to effectively reduce a size of the piercing aperture; and

a cocking and firing mechanism within the housing, wherein the actuator is configured so that the sleeve-engagement portion and the sleeve remain stationary relative to the user-engaging end of the housing when the cocking and firing mechanism moves the needle forward and rearward during incision.

21. The lancing device of claim 20, 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 so that the sleeve is in the rearward position when the control member is moved to the first position.

22. The lancing device of claim 21, further comprising at least one indicia corresponding to incision at the alternate site, wherein the actuator is operative to move the sleeve to the rearward position when a portion of the actuator is positioned in visual association with the indicia.

23. The lancing device of claim 20, 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.

24. The lancing device of claim 20, wherein the sleeve in the forward position is interposed within the piercing aperture to adjust the size of the piercing aperture to a smaller diameter during lancing.

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

Inserting inside the lancing device a lancet having a needle terminating in a sharp tip, a body from which the needle extends and a sleeve directly coupled to the body and movable relative to the body after the lancet is inserted inside the housing, wherein the sleeve is in a locked position encasing the sharp tip of the needle prior to inserting the lancet;

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.

26. The method of claim 25, wherein setting the effective size of the piercing aperture comprises moving the sleeve relative to the piercing aperture so that the sleeve is in one of a forward position and a rearward position relative to the piercing aperture, wherein the sleeve 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.

27. The method of claim 26, wherein the sleeve in the rearward position is sufficiently spaced apart from the piercing aperture so as to not flatten the user'"'"'s skin during incision.

28. The method of claim 26, wherein setting the effective size of the piercing aperture comprises holding the needle stationary relative to the piercing aperture while moving the sleeve.

29. The method of claim 26, wherein incising the user'"'"'s skin further comprises extending and retracting the sharp tip of the needle through the piercing aperture while holding the sleeve stationary relative to the piercing aperture.

30. The method of claim 25, 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.