Disposable/single-use blade lancet device and method

• US 8,454,642 B2
• Filed: 03/08/2010
• Issued: 06/04/2013
• Est. Priority Date: 11/03/2005
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steve
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US12/719,647
• Publication Number:
  US 20100168776A1
• Time in Patent Office: 1,184 Days
• Field of Search: 606181-182, 600/573, 600/583, 303/35
• US Class Current: 606/182
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150465 Specific design of proximal end
• CPC Class Codes: A61B 5/150587 by friction fit
• 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 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: Y10T 83/04 Processes

Abstract

Single-use blade lancet device includes a body having a rear end and a front end. A triggering mechanism has a blade tip opening and is mounted to the body. A blade member is movably mounted within the body and includes a front end and a rear end. The blade member is movable at least between a first retracted position, an extended position, and a second retracted position. A biasing arrangement biases the blade member from the first retracted position towards the extended position and then towards the second retracted position. A guiding arrangement guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Claims

1. A single-use blade lancet device, comprising:

a body comprising a rear end and a front end;

a triggering mechanism comprising a blade tip opening, the triggering mechanism being at least one of associated with the body and mounted to the body;

a blade member movably mounted within the body and comprising a front end and a rear end;

the blade member being movable at least between a first retracted position, an extended position, and a second retracted position;

a biasing arrangement that biases the blade member from the first retracted position towards the extended position and then towards the second retracted position; and

a guiding arrangement which guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position,

wherein, during movement of the blade member, a portion of the blade member moves along a curved path and another portion of the blade member slides in a linear direction which is substantially parallel to an axis extending from the blade tip opening to the rear end of the body, and

wherein at least one of;

the biasing arrangement is spaced from the triggering mechanism and is not in direct contact with the triggering mechanism;

after triggering, the triggering mechanism is arranged completely within the body; and

said biasing arrangement is only one unitary biasing element arranged inside the single-use blade lancet device.

2. The device of claim 1, wherein the biasing arrangement comprises one of:

a spring;

an extension spring; and

a torsion spring.

3. The device of claim 1, wherein the triggering mechanism is movably mounted to the front end of the body.

4. The device of claim 1, wherein the triggering mechanism comprises a cap portion which, at least in the first retracted position, extends out from the body, and at least one arm arranged within the body.

5. The device of claim 1, wherein the body comprises a first housing part connected to a second housing part.

6. The device of claim 1, wherein the blade member comprises a body portion made of one material and a blade tip portion made of a different material.

7. The device of claim 1, wherein the guiding arrangement comprises one of:

two projections coupled to the blade member, a pivotally mounted connecting member, and two substantially parallel guiding members coupled to the body;

two spaced apart guiding projections coupled to one housing part of the body and two spaced apart guiding projections coupled to another housing part of the body;

at least two generally circular projections, a movably mounted connecting member, and at least two spaced apart generally linear guide members;

first and second projections extending from one side of the blade member, a movably mounted connecting member having one end movably connected to the first projection and another end movably connected to a portion of the body, and a slide movably coupled to the second projection and movably guided by two spaced apart members coupled to the body;

a plurality of non-movable projections, a movably mounted connecting member, guiding members coupled to the body, and a movably guided slide.

8. The device of claim 1, wherein the triggering mechanism comprises two arms which deflect away from each other to cause automatic movement of the blade member from the first retracted position to the extended position and then to the second retracted position.

9. The device of claim 1, wherein the front end of the body comprises a generally rectangular-shaped opening which receives therein a generally rectangular-shaped portion of the triggering mechanism.

10. The device of claim 1, wherein the triggering mechanism comprises at least one arm which deflects to cause automatic movement of the blade member from the first retracted position to another more retracted position, then to the extended position, and then to the second retracted position.

11. The device of claim 1, wherein the body comprises a generally rectangular-shaped body having ergonomically-shaped finger gripping portions.

12. The device of claim 1, further comprising a removable cap member which prevents triggering when installed on the body.

13. The device of claim 1, wherein the body is a generally rectangular-shaped body which comprises two generally planar sides defining a thickness, wherein each said side has a finger gripping portion, and wherein the thickness is less than half of a width of the body and less than half of the length of the body, whereby the length is measured between the front and rear ends of the body.

14. The device of claim 1, further comprising a removable safety device configured to prevent movement of the blade member.

15. The device of claim 1, wherein the blade member comprises generally rectangular-shaped metal plate with a pointed blade tip defined by a tapered sharpened edge and a straight blunt edge.

16. The device of claim 1, wherein the guiding arrangement one of:

guides a blade tip of the blade member along a curved path; and

guides a blade tip of the blade member along a partially circular path.

17. The device of claim 1, wherein the blade member one of:

is pivotally mounted at two spaced apart locations;

comprises a width, a thickness and a length, wherein the width is less than the length, and wherein the width is greater than the thickness by a factor of at least five;

comprises a width, a thickness and a length, wherein the width is less than the length, and wherein the width is greater than the thickness by a factor of at least ten.

18. A method of puncturing a surface of skin using the device of claim 1, the method comprising:

disposing a front end of the device against a user'"'"'s skin;

forcing the device against the user'"'"'s skin in order to activate the triggering mechanism and thereby cause a blade tip of the blade member to penetrate and cut the user'"'"'s skin; and

preventing the user from moving the blade member to the extended position and to the first retracted position.

19. A disposable and single-use blade lancet device, comprising:

a body comprising a rear end and a front end;

a cap member arranged at the front end of the body and comprising a blade tip opening;

a blade member movably mounted within the body and comprising a front end and a rear end;

the blade member being movable at least between a first retracted position, an extended position, and a second retracted position that is different than the first retracted position;

a biasing device that causes movement of the blade member from the first retracted position towards the extended position and then towards the second retracted position; and

a guiding arrangement that at least comprises first and second projections, a pivotally mounted connecting member arranged within the body, and a slide arranged within the body and slidably engagable with another portion of the body and with the cap,

wherein the guiding arrangement guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position.

22. The device of claim 19, wherein each of:

the biasing device is spaced from the cap and is not in direct contact with the cap; and

during triggering, the cap is caused to be retracted completely into the body.

20. A disposable and single-use blade lancet device, comprising:

a body comprising a rear end and a front end;

a trigger device having a blade tip opening and being at least one of associated with the body and mounted to the body;

a blade member movably mounted within the body and comprising a front portion and a rear portion;

the blade member being movable between a first retracted position, an extended position, and a second retracted position;

a biasing arrangement that biases the blade member from the first retracted position towards the extended position and then towards the second retracted position; and

a guiding arrangement guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position,

wherein the guiding arrangement comprises a slide which linearly guides a portion of the blade member about which the blade member pivots and a pivotally mounted connecting member which guides another portion of the blade member along a curved path.

21. The device of claim 20, wherein each of:

after triggering, the trigger device is arranged completely within the body; and

only one said biasing arrangement is arranged within the body.