Tissue penetration device

• US 20120283539A1
• Filed: 04/18/2011
• Published: 11/08/2012
• Est. Priority Date: 04/16/2010
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Freeman, Dominique M., Shoup, Thomas, Perry, Jeffrey, Castle, Mark, Kugizaki, Rodney, Englert, Robert, Alden, Don
• Granted Patent: US 8,965,476 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150213 Venting means
• 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 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150427 : Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 : Details of construction of shaft
• 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 5/150824 : 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 5/15146 : Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 : Each piercing element being stocked in a separate isolated compartment
• 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

Abstract

A body fluid testing device has at least one penetrating member and a penetrating member driver configured to be coupled to the at least one penetrating member. A plurality of analyte sensors are coupled to a spoked disk substrate. Each of a penetrating member can pass between spokes of the disk substrate to provide that a used penetrating member can be removed and a new penetrating inserted without removing the disk. A disposable houses the at least one penetrating member and the plurality of analyte sensors.

Claims

1. A body fluid testing device, comprising:

at least one penetrating member;

a penetrating member driver configured to be coupled to the at least one penetrating member;

a plurality of analyte sensors on a spoked disk substrate, wherein each of a penetrating member can pass between spokes of the disk substrate to provide that a used penetrating member can be removed and a new penetrating inserted without removing the disk; and

a disposable housing that houses the at least one penetrating member and the plurality of analyte sensors.

2. The device of claim 1, wherein the plurality of sensors are arrayed on a disk.

4. The device of claim 1, wherein each of a sensor is individually sealed against humidity and in which the cassette housing removes the humidity seal as a new sensor is positioned for use.

5. The device of claim 1, wherein each of sensor is individually sealed against humidity and in which the device removes the humidity seal as a new sensor is positioned for use.

6. The device of claim 1, wherein the penetrating member is configured to be coupled penetrating member driver without mechanically gripping or linking.

7. The device of claim 1, further comprising:

at least one position flag configured to be by a position sensor.

8. The device of claim 1, wherein the penetrating member includes features that work with the disposable to limit a range of motion of the penetrating member.

9. The device of claim 1, further comprising:

a sterility barrier that includes desiccant properties.

3. The device of claim 3, wherein the spoked disk has a plurality of spokes where at least a portion of the spokes are bent out of plane for use.

10. A disposable for a single shot glucose device, comprising:

an over-molded penetrating member, where the over-mold includes a device interface for the penetrating member and the over-mold being a device interface for the penetrating member;

a sensor; and

a disposable for managing handling, location and use of the lancet and a sensor.

11. The disposable of claim 10, wherein the over-mold provides a sterility seal for the penetrating member.

12. The disposable of claim 10, further comprising:

an articulated element of the disposable configured for managing a position of the sensor relative to the penetrating member allowing the sensor to be located off axis with the lancet when not in use,

13. A device for storing analyte sensors, comprising:

a chamber;

a plurality of blood glucose sensors positioned in the chamber; and

a device to urge to sensors against a cap at an end of the chamber.

14. The device of claim 13, wherein the device to urge the sensors is a spring.

15. The device of claim 13, further comprising:

a pocket in a sealing surface of the cap that receives only one blood glucose sensor.

16. The device of claim 13, further comprising:

a seal that maintains an isolated environment inside the chamber to allow desiccant to protect the sensors.