Methods and apparatus for lancet actuation

• US 9,802,007 B2
• Filed: 11/18/2013
• Issued: 10/31/2017
• Est. Priority Date: 06/12/2001
• 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, Freeman, Dominique M.
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): ABOUELELA, MAY A
• APPLICATION: US 20140142543A1
• Time in patent office: 1443 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. An agent injection 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, 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 needle with an interior channel, the needle positionable in the housing;

an agent container coupled to the needle and positioned at the housing;

an actuator processor coupled to a position sensor;

a human interface processor that is lower power and slower than the actuator processor, the human interface processor configured to run intermittently to conserve power for the human interface processor, the human interface processor configured to control power for the actuator processor and is a timer for the actuator processor so that the actuator processor does not remain on for long periods of time;

a human interface coupled to the human interface processor that allows a user to adjust a sampling setting; and

a controllable drive force generator coupled to the actuator processor and configured to be coupled to the needle to advance the needle along a path into a tissue site to a selected depth of the agent.

2. The device of claim 1, wherein the needle has a controllable velocity.

3. The device of claim 1, wherein the agent container is collapsible.

4. The device of claim 3, wherein the agent container is collapsible in response to a signal from the actuator processor.

5. The device of claim 1, further comprising:

a cassette that includes a plurality of needles and a plurality of agent containers.

6. The device of claim 5, wherein the actuator processor provides a series of metered dose of the agent for long-term medication needs.

7. The device of claim 1, wherein the needle is disposable in the housing.

8. The device of claim 1, wherein the needle has a distal end with three facets.

9. A method for delivering an agent from an agent injection device that includes electrical components, comprising:

providing the agent injection device that includes a housing, a needle, an agent container coupled to the needle, an actuator processor and a controllable drive force generator coupled to the actuator processor, the housing including a first housing and a second housing, where the first housing being larger than the second housing, 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;

indicating a low battery output and a device error condition output via a user interface; and

using the controllable drive force generator to advance the needle along a path into a tissue site to a selected depth for delivery of the agent at the selected depth;

using the actuator processor including a memory that stores profiles and in response to the actuator processor selecting a profile, the actuator processor modulating power from a power supply to the controllable drive force generator;

using a human interface processor that is lower power and slower than the actuator processor, the human interface processor configured to run intermittently to conserve power for the human interface processor controlling power to the actuator processor as needed, the human interface processor configured to be a timer for the actuator processor so that the actuator processor does not remain on for long periods of time;

and

using the human interface to allow the user to adjust sampling setting; and

using the actuator processor to customize a drive force generator profile by scaling or modifying the drive force generator profile based on additional user input information.

10. The method of claim 9, wherein the needle has a controllable velocity.

11. The method of claim 9, wherein the agent container is collapsible.

12. The method of claim 11, further comprising:

at least partially collapsing the container in response to a signal from the actuator processor.

13. The method of claim 9, further comprising:

using the actuator processor and a feedback loop to provide a series of metered doses of the agent for long-term medication needs.

14. The method of claim 9, further comprising:

providing a cassette that includes a plurality of needles and a plurality of agent containers.

15. The method of claim 14, further comprising:

providing a series of metered doses of the agent for long-term medication needs.

16. The method of claim 9, wherein the needle has a distal end with three facets.