Methods and apparatus for lancet actuation

• US 9,795,747 B2
• Filed: 06/02/2011
• Issued: 10/24/2017
• Est. Priority Date: 06/02/2010
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Castle, Mark, Kugizaki, Rodney, Englert, Robert, Shoup, Thomas, Perry, Jeff
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): ABOUELELA, MAY A
• Application Number:
  US13/151,613
• Publication Number:
  US 20120271197A1
• Time in Patent Office: 2,336 Days
• Field of Search: 600573, 600583, 606181, 606182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150091 by electricity
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150137 by vibration enhancing collection by vibration A61B5/150175
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• 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 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/15029 for driving devices, i.e. means for driving the piercing element
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150946 : Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150954 : Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15109 : Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/15153 : Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15155 : Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15169 : Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 : Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• 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
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15192 : comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
• 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
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/206 : With automatic needle insertion
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 5/145 : using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/3295 : Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion

Abstract

A lancet driver is provided wherein the driver exerts a driving force on a lancet during a lancing cycle and is used on a tissue site. The driver comprises of a drive force generator for advancing the lancet along a path into the tissue site, and a manual switch for a user interface input.

Claims

1. A lancet device configured to exert a driving force on a lancet during a lancing cycle and used on a tissue site, the lancet device including electrical components, comprising:

a housing, the housing including a first housing and a second housing, where the first housing being larger than the second housing and the first and second housings having dissimilar shapes, the first housing configured to house a battery, and the second housing configured to house the electrical components, a lancet analyte sensor associated with the lancet;

a processor coupled to a drive force generator, the processor and drive force generator positioned in the second housing, the drive force generator configured to be coupled to the lancet to advance the lancet along a path into the tissue site, create a penetration and a subsequent flow of a blood sample into a receiving channel of the second housing and then to the analyte sensor for analysis;

a latching device that holds the a lancet from exiting the lancet device when the lancet device is not in use;

a bearings guide associated with the lancet for accurately defining a lancing trajectory;

a human interface input control configured to provide depth setting range for lancet penetration into the tissue site; and

a human interface coupled to the drive force generator, the human interface position at the second housing, the human interface being a voice system which uses words to describe status or alarms related to the lancet device usage, the voice system including a sound generator configured to provide information to a user relative to at least one of a reminder when a next measurement of a blood sample is needed and an analytic measurement result of a blood sample.

2. The device of claim 1, further comprising:

an LED or light source configured to indicate different user interface outputs selected from at least one of, low battery, charging, lancet present, device error condition, ready to launch, and an indication that the battery requires replacement.

3. The device claim 2, further comprising:

a user interface indicator.

4. The device of claim 1, further comprising:

a multi-position mechanical switch at the second housing.

5. The device of claim 1, wherein the device has a total moving mass that is less than 0.40 g.

6. The device of claim 1, further comprising:

a sterility barrier that seals the lancet prior to use.

7. The device of claim 1, wherein the drive force generator is a controllable drive driver.

8. The device of claim 1, further comprising:

an actuator arm coupled to the drive force generator.

9. The device of claim 1, further comprising:

a coupler configured to be coupled to the drive force generator.