Tissue penetration device

• US 20070173741A1
• Filed: 01/11/2007
• Published: 07/26/2007
• 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, Deshmukh, Ajay, Alden, Don, Freeman, Dominique
• Granted Patent: US 9,314,194 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150152 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 5/150427 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/15146 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 5/15163 : 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 5/15174 : Piercing elements stocked in the form of a stack or pile
• 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/005 : Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles

Abstract

A body fluid sampling system is provided for use on a tissue site. A drive force generator is coupled to penetrating members. The penetrating members are at least partially housed in a penetrating member housing. The penetrating member housing has openings for the penetrating members. The penetrating members are launched along a launch path by the drive force generator through an opening in the penetrating member housing. Analyte sensors are housed in a analyte sensor housing. Each analyte sensor is associated with a penetrating member. The analyte sensor housing and the penetrating member housing are coupled to provide that each analyte sensor is positioned out of a launch path of a penetrating member. The analyte sensor housing includes desiccant pockets for receiving desiccant plugs

Claims

1. A body fluid sampling system for use on a tissue site, the system comprising:

a drive force generator;

a plurality of penetrating members at least partially housed in a penetrating member housing, the penetrating member housing having a plurality of openings with each of an opening associated with a penetrating member, each of a penetrating member being configured to be coupled to the drive force generator and be launched along a launch path through an opening in the penetrating member housing; and

a plurality of analyte sensors housed in an analyte sensor housing, each of an analyte sensor being associated with a penetrating member, the analyte sensor housing and the penetrating member housing being coupled to provide that each of an analyte sensor is positioned out of a launch path of a penetrating member, the analyte sensor housing including a plurality of desiccant pockets each with a desiccant plug.

2. The system of claim 1, wherein each of a desiccant plug is associated with an analyte sensor.

3. The system of claim 1, wherein each of an analyte sensor is aligned to a penetrating member.

4. The system of claim 1, further comprising:

a first seal in a sealing arrangement to at least tip portions of the penetrating members to provide that the tip portions remain in a sterile environment prior to launch of a penetrating member to a tissue site.

5. The system of claim 4, wherein the first seal includes a plurality of seal portions, each of a seal portion associated with a penetrating member.

6. The system of claim 4, wherein a plurality of first seals are provided, each of a first seal being associated with a penetrating member.

7. The system of claim 1, wherein each of a desiccant plug maintains an analyte sensor in a dry environment about prior to launch of a penetrating member into a tissue site.

8. The system of claim 1, wherein the analyte sensor housing is coupled with the penetrating member to provide for a selected alignment of penetrating members to analyte sensors.

9. The system of claim 1, wherein the analyte sensor housing is configured to lock to the penetrating member housing.

10. The system of claim 4, further comprising:

at least a second seal that permits the penetrating members to be in a sterile environment and the desiccant is in a dry environment until launch of a penetrating member.

11. The system of claim 10, further comprising:

at least a third seal that covers the desiccant pockets.

12. The system of claim 1, wherein each of an analyte sensor has its own housing pocket, a front seal and a back seal, wherein each housing pocket is a desiccant pocket.

13. The system of claim 12, wherein each of an analyte sensor is sealed prior to equilibration.

14. The system of claim 12, wherein each of an analyte sensor is sealed after equilibration.

15. The system of claim 1, wherein the penetrating member housing has a disc shaped geometry.

16. The system of claim 1, wherein the analyte sensor housing has a ring shaped geometry.

17. The system of claim 1, wherein the analyte sensor is positioned for blood flow into an analyte sensor upon launch of a penetrating member and penetration of a penetrating member at a skin surface.

18. The system of claim 1, wherein the analyte sensor housing is heat staked to the penetrating member housing.

19. The system of claim 3, wherein a post on either of the penetrating member housing or the analyte sensor housing.

20. The system of claim 1, wherein the analyte sensor housing is glued to the penetrating member housing.

21. The system of claim 1, wherein the analyte sensor housing is ultrasonically welded to the penetrating member housing.

22. The system of claim 1, wherein the analyte sensor housing is laser welded to the penetrating member housing.

23. The system of claim 1, wherein each of an analyte sensor is fixed in the analyte sensor housing with glue.

24. The system of claim 1, wherein each of an analyte sensor is fixed in the analyte sensor housing by ultrasonic welding.

25. The system of claim 1, wherein each of an analyte sensor is fixed in the analyte sensor housing with an interference fit.

26. The system of claim 1, wherein rib structures are used to retain each of an analyte sensor, each of an analyte sensor at least partially deforming associated ribs to create an interference fit.

27. The system of claim 1, wherein features are used to fix each of an analyte sensor, the features being formed after each of an analyte sensor is placed in the analyte sensor housing.

28. The system of claim 1, wherein bearings align the penetrating members to the penetrating member housing.

29. The system of claim 1, wherein the penetrating member housing is aligned to the analyte sensor housing with posts that are formed in the penetrating member housing, and a mating hole and slot in the analyte sensor housing.

30. The system of claim 1, wherein edges of analyte sensors are aligned with walls of pockets formed in the analyte sensor housing.

31. The system of claim 1, wherein female trenches are molded in the analyte sensors and align with mating male features in the analyte sensor housing or male trenches are molded in the analyte sensors and align with mating female features in the analyte sensor housing.

32. The system of claim 1, wherein holes formed in the analyte sensors align with posts in the analyte sensor housing.