Lancets and methods of use

• US 8,016,848 B2
• Filed: 05/30/2007
• Issued: 09/13/2011
• 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: DiPalma, Vincent, Galasso, John, Shur, Maiya, Vizcarra, Damien, Lathrop, Ray Adams, Wyler, Jonathan M., Trissel, John Andrew, Curry, Samuel Mason, Young, Kevin, Flynn, Stephen J.
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US11/755,673
• Publication Number:
  US 20080033468A1
• Time in Patent Office: 1,567 Days
• Field of Search: 606/181, 606/182, 606/167, 606/184, 606/185, 600/583, 600/573, 604/110, 604/192, 604/194, 604/195
• 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

Lancets and methods of use are provided. Embodiments include lancets including a sleeve mounted to an elongated body having a needle terminating in a sharp tip.

Claims

1. A lancet for insertion into and ejection from a lancing device, comprising:

a unitary elongated body having a needle terminating in a sharp tip extending directly from a lancing end of the elongated body;

a sleeve having a front end and a rear end, the sleeve being fixedly disposed about at least a portion of the elongated body and movable relative to the elongated body when the elongated body is held stationary between a forward position in which the sharp tip is protectively surrounded by the sleeve and a rearward position in which the sharp tip projects from the front end of the sleeve; and

a first locking member extending directly from the elongated body at a location intermediate the forward and rearward positions, the first locking member having an extended configuration in which the first locking member extends from the elongated body and contacts a most rearward surface of the rear end of the sleeve to prevent the sleeve from moving to the rearward position, and a retracted configuration in which the first locking member is retracted toward the elongated body and does not engage the sleeve to prevent the sleeve from moving to the rearward position;

wherein at least a portion of an interior of the sleeve is configured to contain the first locking member in the retracted configuration when the sleeve moves over the first locking member, and wherein the first locking member is in the extended configuration engaging the most rearward surface prior to and during both insertion of the lancet into the lancing device and ejection of the lancet from the lancing device;

further comprising a second locking member axially spaced from the first locking member between the first locking member and the sharp tip, wherein the second locking member is of a geometry that is less flexible than a geometry of the first locking member.

5. The lancet of claim 1 wherein the interior of the sleeve comprises an elongated guide surface arranged to contain the first locking member in the retracted configuration when the sleeve moves over the first locking member.

6. The lancet of claim 1 wherein the rear end of the sleeve defines a rear aperture configured to permit entry of the first locking member into the interior of the sleeve when the first locking member is in the retracted configuration and to prevent entry of the first locking member into the interior of the sleeve when the first locking member is in the extended configuration.

7. The lancet of claim 1 wherein the interior of the sleeve has a cross section that is one of polygonal, circular and ovular.

8. The lancet of claim 1 wherein the first locking member is comprised of a resilient deformable material that urges the first locking member to the extended configuration when the first locking member is moved to the retracted configuration.

9. The lancet of claim 1 wherein the sleeve has a width of less than 5 mm.

10. The lancet of claim 1 wherein the first locking member comprises a pair of wings radially extending from opposing sides of the elongated body.

11. The lancet of claim 1, the second locking member movable between an extended configuration extending directly from the elongated body and a retracted configuration retracted toward the elongated body and comprised of a resilient flexible material that urges the second locking member to the extended configuration when the second locking member is moved to the retracted configuration;

wherein the most rearward surface of the rear end of the sleeve defines a rear aperture having a span less than a span of the second locking member in its extended configuration that is configured to permit entry of the second locking member into the interior of the sleeve when the second locking member is in the retracted configuration and to prevent entry of the second locking member into the interior of the sleeve when the second locking member is in the extended configuration; and

wherein the interior of the sleeve is configured to permit the second locking member to return to the extended configuration after entry into the interior.

12. The lancet of claim 11 wherein the second locking member comprises at least one barb.

13. The lancet of claim 1 wherein a distal end of the first locking member in the extended configuration is spaced apart from the elongated body by a first distance, and a distal end of the first locking member in the retracted configuration is spaced apart by a second distance, wherein the second distance is less than the first distance.

14. The lancet of claim 1, wherein the sleeve further comprises an annular flange circumscribing the sleeve between the front end and the rear end, the annular flange having a forward face configured to directly engage a lancet engagement mechanism within the lancing device and a rearward face configured to directly engage an ejection actuator within the lancing device.

15. A lancet assembly, comprising:

a lancet in accordance with claim 1; and

a lancing device comprising;

a housing having a user-engaging end that defines a piercing aperture therethrough, the piercing aperture sized to allow insertion of the lancet therethough; and

a lancet engagement mechanism adapted to receive the lancet when the lancet is inserted through the piercing aperture so that substantially all of the lancet is enclosed by the housing.

2. The lancet of claim I wherein the first locking member extends from the elongated body in a generally forward direction forming an angle with a major axis of the elongated body when the first locking member is in the extended configuration.

3. The lancet of claim 2 wherein the first locking member is substantially parallel to the major axis of the elongated body when the locking member is in the retracted configuration.

4. The lancet of claim 3 wherein the elongated body comprises a well positioned to receive the first locking member in the retracted configuration.

16. A lancet for insertion into and ejection from a lancing device having lancet ejection means, comprising:

a unitary elongated body having a needle terminating in a sharp tip extending directly from a lancing end of the unitary elongated body;

a sleeve having a front end and a rear end and fixedly disposed about at least a portion of the elongated body, the sleeve located at an initial position relative to the elongated body so that the sharp tip is disposed within the sleeve;

a first locking member extending directly from the elongated body toward the sharp tip at a location outside of the sleeve and having an extended configuration adapted to prevent pricking of a user when the lancet is external the lancing device in which the first locking member extends from the elongated body and engages the sleeve to prevent rearward movement of the sleeve and a retracted configuration adapted to allow pricking of the user when the lancet is internal to the lancing device in which the first locking member retracts toward the elongated body and does not engage the sleeve to prevent rearward movement of the sleeve, wherein the first locking member is in the extended configuration prior to and during both insertion of the lancet into the lancing device and ejection of the lancet from the lancing device by the ejection means; and

a second locking member axially spaced from the first locking member and extending directly from the elongated body in the general direction of the sharp tip at a location within the sleeve, wherein the second locking member is of a geometry that is less flexible than a geometry of the first locking member.

17. The lancet of claim 16 wherein the sleeve is movable forward relative to the elongated body when the elongated body is stationary from the initial position to an ejection position, and wherein the second locking member is configured to engage the rear end of the sleeve to prevent rearward movement of the sleeve when the sleeve is moved to the ejection position.

18. The lancet of claim 16 wherein an interior of the sleeve is configured to contain the first locking member in the retracted configuration when the sleeve moves over the first locking member.