Adjustable cap and lancing device and method of use

• US 8,092,476 B2
• Filed: 08/14/2008
• Issued: 01/10/2012
• Est. Priority Date: 08/14/2008
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Curry, Samuel Mason
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US12/191,824
• Publication Number:
  US 20100042129A1
• Time in Patent Office: 1,244 Days
• Field of Search: 606/172, 606/181, 606/182, 606/183, 600/583, 604/136, 604/137, 604/138, 604/139
• US Class Current: 606/181
• 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 5/150198 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 5/150503 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 5/150824 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 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use

Abstract

Disclosed are cap embodiments each comprising a body having a skin-engaging end defining a piercing aperture, a lancet receiver, and an intermediate member. A first cam path is located on one of the lancet receiver and the intermediate member, and a first cam follower is located on the other of the lancet receiver and the intermediate member that engages the first cam path. A second cam path is located on one of the cap body and the intermediate member, and a second cam follower is located on the other of the cap body and the intermediate member that engages the second cam path. The first and second cam paths are configured such that rotation of the intermediate member by an actuating mechanism causes the cap body to move forward and rearward and the lancet receiver to move forward and rearward. Also disclosed are lancing devices and methods of use.

Claims

1. A cap for use with a lancing device having a housing and a lancet firing mechanism disposed therein, the cap comprising:

a cap body having an inner surface and a skin-engaging end that defines a piercing aperture;

a lancet receiver movably mounted in the cap body and having an outer surface, the lancet receiver configured to receive a lancet;

an intermediate member movably mounted in the cap body and having an inner surface facing the outer surface of the lancet receiver;

a first cam path on one of the outer surface of the lancet receiver and the inner surface of the intermediate member;

a first cam follower on the other of the outer surface of the lancet receiver and the inner surface of the intermediate member that engages the first cam path;

a second cam path on one of the inner surface of the cap body and an outer surface of the intermediate member;

a second cam follower on the other of the inner surface of the cap body and the outer surface of the intermediate member that engages the second cam path; and

an actuating mechanism attached to the intermediate member, wherein rotation of the intermediate member by the actuating mechanism causes the second cam follower to move along the second cam path to adjust a penetration depth of the lancet by moving the cap body forward and rearward with respect to the housing and causes the first cam follower to move along the first cam path to adjust an effective size of the piercing aperture by moving the lancet receiver forward and rearward with respect to the housing.

2. The cap of claim 1, wherein the lancet receiver is configured to move between a forward position and a rearward position, and wherein the cap body is configured to move forward and rearward when the lancet receiver is stationary in each of the forward position and the rearward position.

3. The cap of claim 2, wherein the lancet receiver is positioned sufficiently spaced apart from the piercing aperture to permit skin to pucker through the piercing aperture during lancing when in the rearward position.

4. The cap of claim 2, wherein an end of the lancet receiver is circumscribed by and is substantially co-planar with the skin-engaging end when the lancet receiver is in the forward position, the end of the lancet receiver defining the piercing aperture.

5. The cap of claim 2, wherein the cap body moves forward and rearward through a plurality of stages.

6. The cap of claim 1, wherein the lancet receiver is configured to receive the lancet through the piercing aperture such that the lancet engages the lancet firing mechanism and becomes fixedly secured in relation to the housing.

7. The cap of claim 1, wherein the lancet receiver is sized to permit insertion of the lancet therethrough while sufficiently narrow to prevent puckering of skin.

8. The cap of claim 1, wherein the actuating mechanism is one of a manual lever or a stepper motor.

9. The cap of claim 1 further comprising indicia indicating at least one of the position of the lancet receiver and the position of the cap body.

10. A method of use of a cap of a lancing device having a housing and a cap body with an inner surface and a skin-engaging end defining a piercing aperture, the method comprising:

a lancet receiver movably mounted in the cap body, wherein adjusting an effective size of the piercing aperture by moving the lancet receiver between a forward position and a rearward position, wherein an end of the lancet receiver is circumscribed by and is substantially co-planar with the skin-engaging end when the lancet receiver is in the forward position, with the end of the lancet receiver defining the piercing aperture, and the lancet receiver is positioned sufficiently spaced apart from the piercing aperture to permit skin to pucker through the piercing aperture during lancing when in the rearward position; and

adjusting a penetration depth of a lancet by moving the cap body forward and rearward when the lancet receiver is in either of the forward and rearward positions,

wherein the cap body has an intermediate member movably mounted in the cap body and having an inner surface facing an outer surface of the lancet receiver, an outer surface facing the inner surface of the cap body and an actuating mechanism attached to the intermediate member,

wherein adjusting the effective size comprises rotating the intermediate member with the actuating mechanism to move a first cam follower located on one of the outer surface of the lancet receiver and the inner surface of the intermediate member along a first cam path located on the other of the outer surface of the lancet receiver and the inner surface of the intermediate member to move the lancet receiver forward and rearward with respect to the housing, and

wherein adjusting the penetration depth comprises rotating the intermediate member with the actuation member to move a second cam follower located on one of the inner surface of the cap body and the outer surface of the intermediate member along a second cam path on the other of the inner surface of the cap body and the outer surface of the intermediate member such that the cap body moves forward and rearward relative to the housing at a different time than the lancet receiver.

11. The method of claim 10 further comprising:

receiving indication of at least one of the position of the lancet receiver and the position of the cap body from indicia located on the cap body.

12. The method of claim 10, wherein the lancet receiver is sized to permit insertion of the lancet therethrough while sufficiently narrow to prevent puckering of skin.

13. The method of claim 10, wherein the actuating mechanism is one of a manual lever or a stepper motor.

14. A cap for a lancing device including a housing and a lancet firing mechanism disposed in the housing, the cap comprising:

a cap body with a skin-engaging end defining a piercing aperture;

a lancet receiver movably disposed in the cap body;

an intermediate member movably disposed between the lancet receiver and the cap body;

a first cam path and a first cam follower movably connecting the lancet receiver and the intermediate member;

a second cam path and a second cam follower movably connecting the cap body and the intermediate member; and

an actuating mechanism accessible external to the cap body and carried by the intermediate member, wherein rotation of the intermediate member by the actuating mechanism causes the second cam follower to move along the second cam path to adjust a penetration depth of a lancet by moving the cap body forward and rearward relative to the housing and causes the first cam follower to move along the first cam path to adjust an effective size of the piercing aperture by moving the lancet receiver forward and rearward relative to the housing.

15. The lancing device of claim 14, wherein the lancet receiver is configured to move between a forward position and a rearward position, and wherein the cap body is configured to move forward and rearward when the lancet receiver is stationary in each of the forward position and the rearward position.

16. The lancing device of claim 15, wherein the lancet receiver is positioned sufficiently spaced apart from the piercing aperture to permit skin to pucker through the piercing aperture during lancing when in the rearward position, and wherein an end of the lancet receiver is circumscribed by and is substantially co-planar with the skin-engaging end when the lancet receiver is in the forward position, the end of the lancet receiver defining the piercing aperture.

17. The lancing device of claim 14, wherein the lancet receiver is configured to receive a lancet through the piercing aperture such that the lancet engages the lancet firing mechanism and becomes fixedly secured in relation to the housing.

18. The lancing device of claim 14, wherein the cap body moves forward and rearward through a plurality of stages.

19. The lancing device of claim 14, wherein the actuating mechanism is one of a manual lever or a stepper motor.

20. The lancing device of claim 14 further comprising indicia indicating at least one of the position of the lancet receiver and the position of the cap body.