Method and apparatus for a multi-use body fluid sampling device with sterility barrier release

• US 7,226,461 B2
• Filed: 12/18/2002
• Issued: 06/05/2007
• Est. Priority Date: 04/19/2002
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Schumann, Matt, Cane, Michael, Beadman, Michael, Wittig, Michael, Alden, Don
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/323,623
• Publication Number:
  US 20040049220A1
• Time in Patent Office: 1,630 Days
• Field of Search: 606/167, 606/172, 606/173, 606/181, 606/182, 606/183, 600/573, 600/583
• US Class Current: 606/181
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• 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 5/150221 Valves
• 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150916 : by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/151 : Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 : comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• 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 5/15178 : 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 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

A device for use with a gripper is provided. A cartridge is provided that defines a plurality of cavities. A plurality of penetrating members are at least partially contained in the cavities of the cartridge. The penetrating members are slidably movable to extend outward from the cartridge to penetrate tissue. Each cavity has a longitudinal opening that provides access to an elongate portion of the penetrating member. A sterility barrier is coupled to the cartridge. The sterility barrier covers a plurality of the longitudinal openings. The sterility barrier is configured to be moved so that the elongate portion is accessed by the gripper without touching the barrier.

Claims

1. A device comprising:

a cartridge having a plurality of cavities; and

a plurality of penetrating members at least partially contained in said cavities of the single cartridge wherein the penetrating members are slidably movable to extend outward from lateral openings on said cartridge to penetrate tissue;

a sterility barrier coupled to said cartridge, each of a penetrating member having a tip that is not physically connected to the sterility barrier, said sterility barrier covering a plurality of said lateral openings, wherein the sterility barrier covering the lateral openings is configured to be moved so that a penetrating member exits the lateral opening without contacting the barrier.

2. The device of claim 1 wherein the sterility barrier covering the lateral openings is configured to be moved substantially vertically so that a penetrating member exits the lateral opening without contacting the barrier.

3. The device of claim 1 wherein the sterility barrier covering the lateral openings Is configured to be punched downward so that a penetrating member exits the lateral opening without contacting the barrier.

4. The device of claim 1 wherein the sterility barrier covering the lateral openings at least partially breaks away so that a penetrating member exits the lateral opening without contacting the barrier.

5. The device of claim 1 wherein the sterility barrier is positioned to define a surface at an angle between about 3 degrees and 90 degrees, relative to horizontal.

6. The device of claim 1 wherein the sterility barrier is positioned to define a surface at an angle of about 45 degrees, relative to horizontal.

7. The device of claim 1 wherein the sterility barrier is made of a material containing one of the following:

aluminum, polymer, and paper.

8. The device of claim 1 wherein the sterility barrier is made of a laminate made from one of the following:

aluminum, polymer, and paper.

9. The device of claim 1 wherein said cartridge includes at least one narrowed portion creating a frictional coupling with one of the penetrating members.

10. The device of claim 1 wherein said cartridge includes at least one narrowed portion near a sharpened end of each of said penetrating members, said narrowed portion acting as a guide for the penetrating member during actuation.

11. The device of claim 1 wherein said cartridge includes a plurality of indentations for assisting in cartridge indexing.

12. The device of claim 1 wherein said cartridge Includes a plurality of Indentations substantially adjacent an inner radial surface of the cartridge for assisting in cartridge indexing.

13. The device of claim 1 wherein said cartridge includes a plurality of indentations on the cartridge for assisting in cartridge indexing, wherein the Indentations are not located on an outer peripheral surface of the cartridge.

14. The device of claim 1 wherein said cartridge includes a plurality of notches positioned to gather excess material from the sterility barrier.

15. The device of claim 1 wherein said plurality of penetrating members have sharpened tips pointed radially inward and said members are movable radially inward to penetrate tissue.

16. The device of claim 1 wherein the cartridge has a flat radial configuration.

17. The device of claim 1 wherein the cartridge includes at least a portion having a conical configuration.

18. The device of claim 1 having at least one empty cavity for receiving a penetrating member gripper when the cartridge is loaded.

19. The device of claim 1 wherein said plurality of penetrating members are substantially in a common plane.

20. The device of claim 1 wherein said plurality of penetrating members are bare lancets.

21. The device of claim 1 wherein said cavity includes an indentation for receiving a penetrating member gripper.

22. The device of claim 1 wherein each penetrating member rests on a protrusion In the cavity, said protrusion configured to facilitate engagement of the penetrating member with a slot on a penetrating member gripper.