Lancet apparatus and methods

• US 5,951,582 A
• Filed: 05/22/1998
• Issued: 09/14/1999
• Est. Priority Date: 05/22/1998
• Status: Expired due to Term

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Thorne, David L., Thorne, Gale H., Owen, Charles V., Thorne, Michael L.
• Primary Examiner(s): Dawson, Glenn K.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/084,112
• Time in Patent Office: 480 Days
• Field of Search: 606/167, 606/181, 606/182, 606/183, 606/185, 600/573, 600/576, 600/578, 600/583
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150465 Specific design of proximal end
• CPC Class Codes: A61B 5/150801 Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
• 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 5/15128 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

Abstract

A one-time-use, self-powered, restricted entry lancet apparatus which provides a smaller incision in a surface or epidermal layers of a lancing site than in subsurface or dermal layers. Two embodiments of the invention are disclosed. Generally, each embodiment includes a housing, a blade component, a rotary spring and an actuator. The blade generally has a proximal portion and a distal section. The proximal portion is disposed within the housing and is displaced laterally in a first direction during a lancing procedure. During the lancing procedure, the distal section is extended from the housing through an open exit slot and is rotated about an abutment member of the exit slot to be laterally displaced in a direction opposite the first direction. This rotation about the abutment results in an incision pattern which has a smaller cut in the epidermis than in the dermis. Thus, surface trauma is reduced while a broad cut is made in capillary rich regions of the dermal layers.

Claims

1. A one-time-use, self-powered lancet apparatus comprising:

a housing comprising a hollow space for fully containing a lancet blade member, and an open frame forming a slot through which a blade portion of the lancet blade member is extended and retracted;

the lancet blade member which comprises a proximally disposed planar portion having an aperture for communicating with an energy-storing memory element and a distally disposed elongated thin blade section having a sharpened tip and at least one sharpened edge;

the energy storing memory element comprising a latching member by which the element is retained in an energy storing state and a part which is displaced as stored energy is released, said part being disposed to communicate with the aperture;

a lancet actuation mechanism comprising a releasible catch which displaceable within the housing to releasibly restrain the latching memory element and an element is displaced to release the latching member to free the energy storing member to initiate a lancing procedure; and

said frame comprising a side abutment, said energy storing memory element comprising an energy release vector and said blade section comprising a blade edge such that, when the energy storing memory element is freed and displaces the proximal portion in a given direction, the blade edge communicates with the side abutment to displace the blade section disposed within the frame in an arcuate direction opposite to the given direction such that a resulting lancing incision has a characteristic pattern having a smaller cut at the surface of the incision than in the subsurface thereof.

2. A lancet apparatus according to claim 1 wherein the energy storing memory element comprises a spring.

3. A lancet apparatus according to claim 2 wherein the spring comprises a torsion spring.

4. A lancet apparatus according to claim 3 wherein said torsion spring comprises a post which communicates with the aperture.

5. A lancet apparatus according to claim 1 wherein said housing comprises a hub which comprises a groove which is the catch.

6. A lancet apparatus according to claim 1 wherein said latching member and said part are integral.

7. A lancet apparatus according to claim 1 wherein said lancet actuation mechanism comprises a button disposed to be displaced transversely relative to a plane of the blade member.

8. A lancet apparatus according to claim 1 wherein said lancet actuation mechanism comprises a slider which is displaced parallel to a plane of the blade member.

9. A lancet actuating apparatus according to claim 1 wherein said housing comprises a guide track which communicates with said displaced part to restrictively control breadth and depth of the pattern.

10. A method of lancing comprising the steps of:

providing a lancet actuating apparatus comprising;

a housing having a side which is disposed against a site to be lanced during a lancing procedure, said side comprising a blade exit and reentry slot;

a lancet blade component safely disposed within said housing prior to use in the lancing procedure, said component comprising a proximally disposed portion which remains in the housing during the lancing procedure and a blade, having a sharpened tip and at least one cutting edge, at least a segment of said blade exits the housing to perform a lancing procedure and returns to the housing for safe disposal;

an energy storing memory element which, when actuated, communicates with said proximally disposed portion to urge the blade through a predetermined lancing pattern outwardly and then inwardly through the blade exit and reentry slot;

a lancet actuating mechanism comprising a release trigger which activates the energy storing memory element;

placing the apparatus against a site to be lanced;

triggering release of the energy storing memory element which subsequently communicates with the proximally disposed portion to accomplish the following steps;

forcibly steering the proximally disposed portion to guide the blade obliquely outward through the slot;

rotating the blade laterally about an edge of the slot under influence of the memory element and, thereby, displacing the proximally disposed portion in a first direction relative to said slot while at the same time displacing the blade in a direction opposite the first direction such that the sharpened tip and cutting edge produce a smaller incision in a surface of the site being lanced than in a subsurface thereof;

returning the blade into the housing.

11. A method according to claim 10 wherein said housing comprises a guide track and said energy storing memory element comprises a track follower and which act in combination during the rotating step thereby restricting the depth of the lance in the subsurface as the blade rotates in the opposite direction.

12. A method according to claim 10 wherein said forcibly steering and rotating steps comprise partially unwinding a torsion spring.

13. A lancet apparatus comprising:

a housing comprising a frame about an opening through which a lancet is extended and retracted and against which a site to be lanced is disposed during a lancing procedure;

the lancet comprising an elongated, thin knife-like blade and a sharpened point;

an energy storing memory element which, when actuated, communicates with the lancet to urge the blade through a predetermined lancing pattern outwardly and then inwardly through the opening;

a mechanism comprising a trigger for actuating the energy storing memory element;

a segment of said frame acting as a fulcrum against said blade to constrain entry of the blade into the entry site to a breadth of cut which is substantially the same as the maximum width of the portion of blade inserted into the site.