Cap displacement mechanism for lancing device and multi-lancet cartridge

• US 7,377,904 B2
• Filed: 04/15/2005
• Issued: 05/27/2008
• Est. Priority Date: 04/16/2004
• Status: Active Grant

• Current Assignee: Facet Technologies LLC
• Original Assignee: Facet Technologies LLC
• Inventors: LeVaughn, Richard W., Ruf, Christopher J., Robbins, Avi M., Flynn, Stephen J., Lipoma, Michael V., Conway, William E., Irwin, John C., Vanhiel, Brian D., Leutz, Brian D.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US11/107,984
• Publication Number:
  US 20050234494A1
• Time in Patent Office: 1,138 Days
• Field of Search: 600/583, 600/576, 600/575, 600/573, 606/167, 606/181, 606/182, 606/183, 604/411, 604/414, 604/6.15, 604/6.16
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150564 Protectors removed by pulling or pushing
• 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 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• CPC Class Codes: A61B 5/150885 Preventing re-use
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display

Abstract

A medical lancing device including a replaceable multi-lancet cartridge. The lancing device includes an advancing mechanism that advances lancets within the cartridge into an active position, separates a protective cap from the active lancet, and energize a drive mechanism of the lancing device. A cap displacement mechanism moves the separated cap out of the travel path of the active lancet. In a first example embodiment, the cap displacement mechanism includes a cantilevered spring arm that displaces the detached cap of the active lancet. In a second example embodiment, the cap displacement mechanism includes a spring-biased cam-driven plunger that displaces the detached cap of the active lancet. Then an activation mechanism releases the energized active lancet to traverse the unobstructed lancing stroke path to pierce the subject'"'"'s skin at a desired lancing site.

Claims

1. A cartridge assembly for a lancing device, comprising:

a housing;

a carrier rotationally mounted within the housing;

a plurality of lancets arranged in an array and carried by the carrier, the lancets each having a detachable protective cap, the lancets each rotationally advanceable with the carrier to an active position for use, and the active-positioned lancet radially retractable on the carrier along a lancing stroke path to a charged lancet position; and

a spring element having an affixed first section, a second section that sequentially engages each of the lancet caps, and an intermediate section between the first section and the second section, wherein the intermediate section is ramped and offsets the first section from the second section, wherein the second section is deflectable between a rest position and a charged position, wherein as one of the lancets is rotationally advanced into the active position the lancet cap of the active-positioned lancet is moved into interfering engagement with and slides across the ramped intermediate section to deflect the second section to the charged position where the second section exerts a charged force on the active-positioned cap, wherein as the active-positioned lancet is radially retracted to the charged lancet position the active-positioned cap is detached from the active-positioned lancet and the charged force of the charged-position second section biases and displaces the active-positioned detached cap from the lancing stroke path of the active-positioned lancet as the second section discharges and returns to the rest position clear of the lancing stroke path, wherein as each one of the lancets is advanced into the active position its cap is displaced out of the lancing stroke path without any manual cap-displacing action by the user,

wherein the carrier includes a plurality of guide tracks defining an array of transverse guide paths along which the lancet caps are displaced transversely from the lancing stroke path, and wherein the guide tracks are adapted to retain the lancet caps within the housing after displacement from the lancing stroke path.

2. The cartridge assembly of claim 1, wherein the spring element comprises a cantilevered leaf spring that is oriented transverse to the lancing stroke path so that it is deflected in a plane that is generally perpendicular to the lancing stroke path by engagement with the active-positioned cap and the caps are moved out of the lancing stroke path in the plane that is generally perpendicular to the lancing stroke path.

3. The cartridge assembly of claim 1, wherein the first section of the spring element is attached to an inner surface of a top or bottom portion of the housing.

4. The cartridge assembly of claim 1, wherein the transverse guide paths are out of a plane defined by the lancet array.

5. The cartridge assembly of claim 1, wherein the lancet caps define one or more cap guide surfaces that engage and ride along the guide tracks as the caps are displaced from the lancing stroke path.

6. The cartridge assembly of claim 5, wherein the guide tracks engage the cap guide surfaces to retain the active-positioned cap from being retracted with the active-positioned lancet so that the retained active-positioned cap separates from the retracted active-positioned lancet.

7. The cartridge assembly of claim 5, wherein the guide tracks comprise resilient elongated members extending from the carrier, and the cap guide surfaces comprise two shoulders projecting from opposing sides of the cap.

8. The cartridge assembly of claim 7, wherein the guide tracks comprise fingers, bars, or detents.

9. The cartridge assembly of claim 1, wherein the carrier defines radial guide channels that receive the lancets in a radial arrangement.

10. A lancing device in combination with the cartridge assembly of claim 1.

11. The combination lancing device and cartridge assembly of claim 10, further comprising an advancer mechanism adapted to advance the lancets into the active position and a drive mechanism including a drive member adapted to engage and retract the active-positioned lancet to detach the corresponding active-positioned cap.

12. A cartridge assembly for a lancing device, comprising:

a housing;

a carrier rotationally mounted within the housing;

a plurality of lancets arranged in an array and carried by the carrier, the lancets each having a detachable protective cap, the lancets each rotationally advanceable with the carrier to an active position for use, and the active-positioned lancet retractable on the carrier along a lancing stroke path to a charged position;

one or more guide tracks that engage the caps to retain the active-positioned cap from being retracted with the active-positioned lancet so that the retained active-positioned cap separates from the retracted active-positioned lancet; and

a cap displacement mechanism consisting of a single spring element that is rotationally movable relative to the lancets and the caps to sequentially engage each of the lancet caps, deflect from a rest position to a charged position, and displace each of the lancet caps from the lancing stroke path as the lancets are rotationally advanced to the active position and retracted to the charged position.

13. The cartridge assembly of claim 12, wherein the spring element consists of a cantilevered leaf spring having a first section stationarily attached within the housing and a second section that engages the lancet caps, wherein the cantilevered leaf spring is oriented transverse to the lancing stroke path so that it is deflected to the charged position in a plane that is generally perpendicular to the lancing stroke path by engagement with the active-positioned cap and the caps are moved out of the lancing stroke path in the plane that is generally perpendicular to the lancing stroke path.

14. The cartridge assembly of claim 13, wherein the spring element further consists of a ramped section between the first section and the second section, wherein as one of the lancets is rotationally advanced to the active position, the active-positioned lancet cap engages and slides across the ramped section to deflect the spring element to the charged position where it exerts a charged force on the active-positioned cap, wherein as the active-positioned lancet is retracted to the charged position the active-positioned cap is detached from the active-positioned lancet and the charged force of the charged-position spring element biases and displaces the active-positioned detached cap from the lancing stroke path of the active-positioned lancet.

15. The cartridge assembly of claim 13, wherein as the spring element displaces the active-positioned detached cap from the lancing stroke path, the spring element discharges and returns to the rest position clear of the lancing stroke path and ready to engage and displace a subsequent one of the lancet caps.

16. The cartridge assembly of claim 12, wherein the guide tracks are defined by the carrier and define an array of transverse guide paths along which the lancet caps are transversely displaced from the lancing stroke path.

17. The cartridge assembly of claim 16, wherein the lancet caps define one or more cap guide surfaces that engage and ride along the guide tracks as the caps are displaced from the lancing stroke path.

18. The cartridge assembly of claim 17, wherein the guide tracks comprise resilient elongated members extending from the carrier, and the cap guide surfaces comprise two shoulders projecting from opposing sides of the cap, wherein the resilient guide tracks contact the shoulders with a snug fit to retain the lancet caps within the housing after displacement from the lancing stroke path.

19. A lancing device in combination with the cartridge assembly of claim 12.

20. The combination lancing device and cartridge assembly of claim 19, further comprising an advancer mechanism adapted to sequentially advance the lancets into the active position, and a drive mechanism adapted to retract the active-positioned one of the lancets to detach the corresponding active-positioned cap.

21. A lancing device, comprising:

a plurality of lancets arranged in an array, wherein the lancets each have a detachable protective cap;

an advancer mechanism adapted to advance the lancets sequentially into an active position for use;

a drive mechanism including a drive member that is adapted to engage and retract an active-positioned one of the lancets along a lancing stroke path to a charged position;

at least one guide track that engages an active-positioned one of the caps and retains it from being retracted along with the active-positioned lancet when the active-positioned lancet is retracted to the charged position, wherein when the active-positioned lancet is retracted to the charged position then the retained active-positioned cap separates from the active-positioned lancet; and

a cap-displacement mechanism including a spring element that moves relative to the lancets and the caps to sequentially come into engagement with each of the lancet caps, wherein as the lancets are advanced by the advancer mechanism the spring element comes into interfering engagement with the active-positioned cap and in response thereto progressively deflects from a rest position to a charged position exerting a charged force against the active-positioned cap, and wherein as the active-positioned lancet is retracted by the drive mechanism to separate the active-positioned cap therefrom then the charged force of the spring element discharges and displaces the separated active-positioned cap from the lancing stroke path.

22. The lancing device of claim 21, wherein the guide tracks are transversely oriented relative to the lancing stroke path and define transverse guide paths that guide the separated caps transversely out of the lancing stroke path.

23. The lancing device of claim 22, further comprising a carrier that carries the lancets, wherein the transverse guide tracks are defined by the carrier.

24. The lancing device of claim 21, wherein the spring element includes a cantilevered leaf spring having a fixed first section and a second section that sequentially engages the lancet caps, wherein the cantilevered leaf spring is oriented transverse to the lancing stroke path so that the second section is deflected to the charged position within a plane that is generally perpendicular to the lancing stroke path by engagement with the active-positioned cap and so that the caps are displaced out of the lancing stroke path within the plane that is generally perpendicular to the lancing stroke path.

25. The lancing device of claim 24, wherein the spring element further includes a ramped section between the first section and the second section, wherein as one of the lancets is advanced to the active position, the active-positioned cap engages and slides across the ramped section to progressively deflect the second section to the charged position.