Tissue penetration device

• US 20070142748A1
• Filed: 12/14/2006
• Published: 06/21/2007
• Est. Priority Date: 04/19/2002
• Status: Abandoned Application

• Current Assignee: Pelikan Technologies, Inc.
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Deshmukh, Ajay, Alden, Don, Freeman, Dominique
• Application Number:
  US11/610,612
• Publication Number:
  US 20070142748A1
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• 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 5/150435 Specific design of proximal end
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15113 : 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 5/15128 : comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• 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 5/15178 : 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 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• 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 2005/005 : Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• CPC Class Codes: B01L 2200/027 : for microfluidic devices
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/147 : Employing temperature sensors
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/1827 : using resistive heater
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/0605 : check valves
• CPC Class Codes: B01L 3/502707 : characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces

Abstract

A body fluid sampling system for use on a tissue site includes a drive force generator. A plurality of penetrating members are housed in a penetrating member housing. Each of penetrating member is configured to be coupled to the drive force generator. A plurality of analyte sensors are housed in an analyte sensor housing. Each analyte sensor is associated with a penetrating member. The analyte sensor housing is in a surrounding relationship to the penetrating member housing and positioned to provide that upon launch of a penetrating member, and penetration of a penetrating member at a skin surface, blood flows into the analyte sensor.

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 housed in a penetrating member housing, each of a penetrating member being configured to be coupled to the drive force generator;

a plurality of analyte sensors housed in an analyte sensor housing, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member; and

wherein the analyte sensor housing is in a surrounding relationship to the penetrating member housing.

2. 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.

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

4. The system of claim 3, wherein a post on the penetrating member housing extends through a hole in the analyte sensor housing.

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

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

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

8. The system of claim 1, further comprising:

a user interface coupled to a processor, wherein in response to an input at the user interface by a user the processor provides an input to the drive force generator of a lancing penetration parameter selected from at least one of, penetrating member depth of penetration, velocity, braking, or retraction.

9. The system of claim 6, wherein the user interface is configured to provide a user with at least one input selected from, depth of a penetrating member penetration, velocity of a penetrating member, a desired velocity profile, a velocity of a penetrating member into the target tissue, velocity of the penetrating member out of the target tissue, dwell time of the penetrating member in the target tissue, and a target tissue relaxation parameter.

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

a drive force generator;

a plurality of penetrating members , each of a penetrating member being configured to be coupled to the drive force generator; and

a plurality of analyte sensors fixed in an analyte sensor housing, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member.

11. The system of claim 10, wherein each of an analyte sensor is fixed in the analyte sensor housing with glue.

12. The system of claim 10, wherein each of an analyte sensor is fixed in the analyte sensor housing by ultrasonic welding.

13. The system of claim 10, wherein each of an analyte sensor is fixed in the analyte sensor housing with an interference fit.

14. The system of claim 13, 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 the interference fit.

15. The system of claim 10, 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.

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

a drive force generator;

a plurality of penetrating members , each of a penetrating member being configured to be coupled to the drive force generator;

a plurality of analyte sensors housed in an analyte sensor housing, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member; and

at least one seal that maintains each of an analyte sensor in a dry state.

17. The system of claim 16, wherein each of an analyte sensor is sealed prior to equilibration.

18. The system of claim 17, wherein each of an analyte sensor is sealed after equilibration.

19. The system of claim 16, wherein each of an analyte sensor has an associated seal.

20. The system of claim 16, wherein each of an analyte sensor has its own housing pocket and its own seal.

21. The system of claim 16, wherein each of an analyte sensor has its own housing pocket, a front seal and a back seal.

24. The system of claim 16, wherein each of an analyte sensor has its own housing pocket and its own piece of desiccant.

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

a drive force generator;

a plurality of penetrating members, each of a penetrating member being configured to be coupled to the drive force generator;

a plurality of analyte sensors housed in an analyte sensor housing, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

a desiccant in the analyte sensor housing.

23. The system of claim 22, wherein each of an analyte sensor has its own piece of desiccant.

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

a drive force generator;

a plurality of penetrating members, each of a penetrating member being configured to be coupled to the drive force generator;

a plurality of analyte sensors housed in an analyte sensor housing, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member and having at least a first seal that maintains the analyte sensor in a dry state, the first seal being opened at an analyte sensor prior to launch of a penetrating member associated with that analyte sensor.

26. The system of claim 25, wherein each of an analyte sensor has first and second seals that are front and back seals that are opened prior to launch of a penetrating member.

27. The system of claim 26, wherein each of a penetrating member has a penetrating member seal that maintains the penetrating member in a sterile environment, wherein the penetrating member seal is opened prior to launch of an associated penetrating member.

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

a drive force generator;

a plurality of penetrating members, each of a penetrating member being configured to be coupled to the drive force generator;

a plurality of analyte sensors housed in an analyte sensor housing, each of an analyte sensor of the plurality of analyte sensors being associated with a penetrating member;

wherein each of an analyte sensor is aligned to a penetrating member.

29. The system of claim 28, wherein the penetrating members are aligned to the penetrating member housing.

30. The system of claim 28, wherein the penetrating member housing is aligned to the analyte sensor housing.

31. The system of claim 28, wherein the analyte sensors are aligned to the analyte sensor housing.

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

33. The system of claim 28, 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.

34. The system of claim 28, wherein edges of analyte sensors are aligned with walls of pockets formed in the analyte sensor housing.

35. The system of claim 28, wherein female trenches are molded in the analyte sensors and align with mating male features in the analyte sensor housing.

36. The system of claim 28, wherein holes formed in the analyte sensors align with posts in the analyte sensor housing.