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

• US 20080009892A1
• Filed: 01/26/2007
• Published: 01/10/2008
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Boecker, Dirk, Beadmann, Mike, Cane, Mike, Alden, Don, Freeman, Dominique, Schumann, Matt
• Granted Patent: US 8,430,828 B2
• Time in Patent Office: Days
• 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 disposable having a plurality of cavities; and

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

a sterility barrier that maintains at least a tip of each of a penetrating member in a sterile environment prior to launch of a penetrating member; and

a device that moves that portion of the sterility barrier associated with the penetrating member out of the way of the penetrating member during launch of the penetrating member.

3. The system of claim 1, wherein the device that moves the sterility barrier is a punch movable to penetrate the sterility barrier and release one of the penetrating members from a sterile environment created by the sterility barrier.

4. The system of claim 3 wherein the punch is positioned to penetrate the sterility barrier of a cavity adjacent an active cavity.

5. The system of claim 3 wherein the punch is positioned to penetrate the sterility barrier of a cavity that is not an active cavity.

6. The system of claim 3 wherein the punch moves vertically when urged by a cam surface.

7. The system of claim 3 wherein the disposable moves vertically when urged by a cam surface.

8. The system of claim 3 further comprising a cam having a radial configuration for urging the motion of the punch.

9. The system of claim 3 further comprising a cam having a radial configuration for urging the motion of a disposable pusher which in turn moves the disposable.

10. The system of claim 3 further comprising a ratchet mechanism preventing a cam urging the motion of the punch from moving in reverse.

11. The system of claim 3 further comprising a mechanical slider actuated by a user, said slider configured to actuate a cam that urges the motion of the punch.

12. The system of claim 3 further comprising an electrically powered force generator for actuating an active one of said penetrating members.

13. The system of claim 3 further comprising:

an electrically powered force generator for actuating an active one of said penetrating members;

a position sensor coupled to said force generator used to determine position of an active one of said penetrating members.

2. A device comprising:

a disposable having a plurality of cavities; and

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

a plurality of sterility barriers, each of a sterility barrier maintaining at least a tip of each of a penetrating member in a sterile environment prior to launch of the penetrating member; and

a device that moves the sterility barrier associated with the penetrating member out of the way of the penetrating member during launch of the penetrating member.

14. A device comprising:

a disposable having a plurality of cavities; and

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

a sterility barrier that maintains at least a tip of each of a penetrating member in a sterile environment prior to launch of a penetrating member; and

a device that moves that portion of the sterility barrier associated with the penetrating member out of the way of the penetrating member during launch of the penetrating member.

15. The system of claim 14, wherein the device that moves the sterility barrier is a punch movable to penetrate the sterility barrier and release one of the penetrating members from a sterile environment created by the sterility barrier.

16. The system of claim 15, wherein the punch is positioned to penetrate the sterility barrier of a cavity adjacent an active cavity.

17. The system of claim 15, wherein the punch is positioned to penetrate the sterility barrier of a cavity that is not an active cavity.

18. The system of claim 15, wherein the punch moves vertically when urged by a cam surface.

19. The system of claim 15, wherein the disposable moves vertically when urged by a cam surface.

20. The system of claim 15, further comprising a cam having a radial configuration for urging the motion of the punch.

21. The system of claim 15, further comprising a cam having a radial configuration for urging the motion of a disposable pusher which in turn moves the disposable.

22. The system of claim 15, further comprising a ratchet mechanism preventing a cam urging the motion of the punch from moving in reverse.

23. The system of claim 15, further comprising a mechanical slider actuated by a user, said slider configured to actuate a cam that urges the motion of the punch.

24. The system of claim 15, further comprising an electrically powered force generator for actuating an active one of said penetrating members.

25. The system of claim 15, further comprising:

an electrically powered force generator for actuating an active one of said penetrating members;

a position sensor coupled to said force generator used to determine position of an active one of said penetrating members.

26. A device comprising.

a disposable having a plurality of cavities;

and

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

a plurality of sterility barriers, each of said sterility barrier maintaining at least a tip of each of a penetrating member in a sterile environment prior to launch of the penetrating member; and

a device that moves the sterility barrier associated with the penetrating member out of the way of the penetrating member during launch of the penetrating member.

27. A device comprising:

a disposable having a plurality of cavities; and

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

a sterility barrier that maintains at least a tip of each of a penetrating member in a sterile environment prior to launch of a penetrating member, wherein the tip of the penetrating member moves that portion of the sterility barrier associated with the penetrating member out of the way of the penetrating member during launch of the penetrating member.

28. A device comprising:

a disposable having a plurality of cavities; and

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

a plurality of sterility barriers, each of a sterility barrier maintaining at least a tip of each of a penetrating member in a sterile environment prior to launch of the penetrating member, wherein the tip of the penetrating member moves the sterility barrier associated with the penetrating member out of the way of the penetrating member during launch of the penetrating member.

29. A device comprising:

a disposable having a plurality of cavities; and

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

a sterility barrier that maintains at least a tip of each of a penetrating member in a sterile environment prior to launch of a penetrating member, wherein tips of the penetrating members reside in the sterility barrier.

30. A device comprising:

a disposable having a plurality of cavities;

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

a plurality of sterility barriers, each of a sterility barrier maintaining at least a tip of each of a penetrating member in a sterile environment prior to launch of the penetrating member, wherein the tips of the penetrating member reside inside the plurality of sterility barriers.