Methods and apparatus for lancet actuation

• US 9,744,312 B2
• Filed: 06/12/2015
• Issued: 08/29/2017
• Est. Priority Date: 06/12/2001
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Castle, Mark, Kugizaki, Rodney, Englert, Robert, Shoup, Thomas
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): ABOUELELA, MAY A
• Application Number:
  US14/738,117
• Publication Number:
  US 20160129204A1
• Time in Patent Office: 809 Days
• Field of Search: 600576, 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, comprising:

a housing;

a needle with an interior channel, the needle is positionable in the housing;

an agent container coupled to the needle;

a processor coupled to a position sensor, the processor is programmed to allow a user to rank results of a lancing event to store the results and constructs a database for the user;

to use the database to calculate profile traits of the user to optimize the profile of user for subsequent lancing events;

a human interface that allows the user to control the sampling interface setting; and

a controllable drive force generator coupled to the processor and configured to be coupled to the needle, the drive force generator is configured to advance the needle along a path into a tissue site to a selectable depth for delivery of the agent at the selected depth, the position sensor coupled to the controllable drive force generator to control power delivery to the needle.

2. The device of claim 1, wherein the controllable drive force generator and the processor provides a controllable velocity of the needle.

3. The device of claim 1, wherein the controllable drive force generator and the processor provides a determination of penetration of the needle and the tissue site.

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

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

6. The device of claim 1, further comprising:

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

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

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

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

10. The device of claim 1, wherein the processor provides the agent delivery occurring at a point of maximum penetration of the needle.

11. The device of claim 1, wherein the processor provides the agent delivery occurring during retraction of the needle.

12. The device of claim 1, wherein the processor provides the agent delivery occurring during insertion of the needle.

13. The device of claim 12, wherein the processor provides the agent delivery continuing as the needle is being withdrawn.

14. A method for delivering an agent from an agent injection device, comprising:

providing an agent delivery device that includes a housing, a needle, an agent container coupled to the needle, a processor and a controllable drive force generator coupled to the needle;

the processor is programmed to allow a user to rank results of a lancing event;

to store the results and constructs a database for the user;

to use the database to calculate profile traits of the user to optimize the profile of the user for subsequent lancing events;

using a human interface that allows the user to control the sampling interface setting;

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

using a position sensor coupled to the controllable drive force generator to control power delivery to the needle.

15. The method of claim 14, further comprising:

using the controllable drive force generator and the processor provides a controllable velocity of the needle.

16. The method of claim 14, further comprising:

using the controllable drive force generator and the processor provides a determination of penetration of the needle and the tissue site.

17. The method of claim 14, wherein the agent container is collapsible.

18. The method of claim 17, further comprising:

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

19. The method of claim 14, wherein the needle is disposable in the housing.

20. The method of claim 14, further comprising:

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

21. The method of claim 20, further comprising:

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

22. The method of claim 14, wherein the needle has a distal end with three facets.

23. The method of claim 14, further comprising:

using the processor to provide the agent delivery at a point of maximum penetration of the needle.

24. The method of claim 14, further comprising:

using the processor to provide the agent delivery during retraction of the needle.

25. The method of claim 14, further comprising:

using the processor to provide the agent delivery during insertion of the needle.

26. The method of claim 25, further comprising:

using the processor to provide the agent delivery continuing as the needle is being withdrawn.

27. An agent injection device, comprising:

a housing;

a needle positionable in the housing;

an agent container coupled to the needle, the agent container includes an agent that is a drug;

a processor coupled to a position sensor, the processor is programmed to allow a user to rank results of a lancing event;

to store the results and constructs a database for the user;

to use the database to calculate profile traits of the user

to optimize the profile of user for subsequent lancing events; and

a controllable drive force generator coupled to the processor and configured to be coupled to the needle for advancing the needle along a path into a tissue site to a selectable depth in the tissue site for a delivery of the agent at the selected depth, the processor and the controllable drive force generator are configured to place the needle in the tissue site for injection of the agent.