Method and apparatus for a fluid sampling device

• US 9,820,684 B2
• Filed: 06/03/2005
• Issued: 11/21/2017
• Est. Priority Date: 06/03/2004
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique, Schulte, Thomas, Cane, Michael, Alden, Don, Schumann, Matt
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/088,370
• Publication Number:
  US 20100286560A1
• Time in Patent Office: 4,554 Days
• Field of Search: 600583, 600575, 600341, 600573, 606181
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150312 Sterilisation of piercing elements, piercing devices or sampling devices piercing element stocking means, e.g. cartridges, A61B5/15176
• 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 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 5/150541 Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
• 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 5/15149 Arrangement of piercing elements relative to each other
• 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 5/15159 : Piercing elements stocked in or on a disc
• CPC Class Codes: A61B 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15176 : 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 5/1518 : Security or safety mechanism to be deactivated for forwarding next piercing element
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

Abstract

Methods and apparatus are provided for manufacturing an analyte detecting device. In one embodiment, the apparatus comprises a housing; a penetrating member driver; a cartridge containing a plurality of penetrating members; a display on the cartridge; a linear slider on the housing, the slider coupled to a rod; and the rod moving with the slider, the rod having at least one roller. The device uses the linear motion of the slider to rotate the cartridge, punch open a new cavity and load a new penetrating member.

Claims

1. A fluid sampling device comprising:

a housing;

a cartridge positioned in the housing

a plurality of body fluid sensing strips integrated into a multi-strip roll;

at least one penetrating member positioned in the cartridge;

a gripper engaged to a penetrating member;

a drive assembly coupled to the cartridge;

a member for moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate; and

a sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier, wherein the offset pad is a multi-layer laminate, the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier.

2. The device of claim 1 wherein a cam surface is aligned parallel to a slider.

3. The device of claim 1 wherein a linear motion of a cam rotates the cartridge and moves a plunger to break the sterility barrier on the cartridge.

4. The device of claim 1 wherein a cam surface comprises a linear strip of maternal with at least two raised portions and two depressed portions.

5. A fluid sampling device comprising;

a housing;

a cartridge defining a plurality of cavities, said cartridge sized to fit within said housing;

a plurality of body fluid sensing strips integrated into a multi-strip roll;

a plurality of penetrating members at least partially contained in said cavities of the cartridge wherein each of a penetrating member is slidably movable, to extend outward from said cartridge to penetrate tissue;

said cavities each having a lateral opening providing access to an elongate portion of the penetrating member;

a gripper configured to be engaged with each of a penetrating member;

a drive assembly coupled to the cartridge;

a sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier, wherein the offset pad is a multi-layer laminate, the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier; and

a member for moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate.

6. A device comprising:

a housing;

a penetrating member driver;

a cartridge containing a plurality of penetrating members;

a plurality of body fluid sensing strips integrated into a multi-strip roll;

a display on said cartridge;

a linear slider on the housing, said slider coupled to a rod;

said rod moving with said slider, said rod having at least one roller using a linear motion of the slider to rotate the cartridge, punch open a new cavity and load an unused penetrating member;

a gripper configured to be engaged with each of a penetrating member;

a driver coupled to the cartridge;

a member for moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate;

a sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier wherein the offset pad is a multi-layer laminate the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier.

7. A device comprising:

a cartridge having a plurality of cavities;

a plurality of body fluid sensing strips integrated into a multi-strip roll;

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 sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier wherein the offset pad is a multi-layer laminate, the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier;

a gripper configured to be engaged with each of a penetrating member;

a drive assembly coupled to the gripper; and

a member for moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate.

8. A method for obtaining a fluid sample comprising:

removing a protective covering from a packaging exposing a single item of sterile blood barrier;

positioning cartridge that contains a plurality of penetrating members in a position to launch a penetrating member;

using a plurality of body fluid sensing strips in the form of an integrated multi-strip roll;

engaging each of a penetrating member with a gripper;

engaging the cartridge with a drive assembly; and

moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate;

providing a sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier, wherein the offset pad is a multi-layer laminate, the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier; and

lancing the patient.

9. The method of claim 8, wherein the sterile blood barrier is replaced for each of a new patient.

10. The method of claim 9, wherein the sterile blood barrier is placed between the device and the patient.

11. The method of claim 9, wherein the sterile blood barrier is used to prevent contamination of any part of the device that can be a pathway for transmission of pathogens between patients.

12. The method of claim 8, further comprising:

a plurality of analyte sensing members, each of an analyte sensing member associated with a penetrating member.

13. A method of indexing comprising:

providing a fluid sampling device that includes a housing, a plurality of penetrating members positioned in a cartridge that is positioned in the housings and a plurality of analyte sensing members;

providing a plurality of body fluid sensing strips integrated into a multi-strip roll;

using a gripper to engage with each of a plurality of penetrating members;

engaging the cartridge with a drive assembly;

providing a sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier, wherein the offset pad is a multi-layer laminate, the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier; and

using a member for moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate.

14. The method of claim 13, wherein a new disposable blood barrier is used when a fluid sample is obtained for a different patient to prevent contamination from one patient to another patient.

15. A fluid sampling device comprising:

a housing;

a cartridge positioned in the housing;

a plurality of body fluid sensing strips integrated into a multi-strip roll;

at least one a penetrating member positioned in the cartridge;

a gripper engaged to a penetrating member;

a drive assembly coupled to the gripper;

a sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier, wherein the offset pad is a multi-layer laminate, the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier; and

a member for moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate.

16. A fluid sampling device comprising:

a housing;

a cartridge defining a plurality of cavities, said cartridge sized to fit within said housing;

a plurality of body fluid sensing strips integrated into a multi-strip roll;

a plurality of penetrating members at least partially contained in said cavities of the cartridge wherein each of a penetrating member is slidably movable to extend outward from said cartridge to penetrate tissue, said cavities each having a lateral opening providing access to an elongate portion of the penetrating member;

a gripper configured to be engaged with each of a penetrating member;

a drive assembly coupled to the cartridge;

a sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier, wherein the offset pad is a multi-layer laminate, the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier; and

a member for moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate.

17. A device comprising:

a cartridge having a plurality of cavities;

a plurality of body fluid sensing strips integrated into a multi-strip roll;

a plurality of penetrating members at least partially contained in said cavities of the single cartridge wherein each of the plurality of penetrating members is slidably movable to extend outward from lateral openings on said cartridge to penetrate tissue, each of a lateral opening associated with a penetrating member;

a sterile blood barrier with an offset pad to maintain an air gap between a patients'"'"' finger and the sterile blood barrier, wherein the offset pad is a multi-layer laminate, the sterile blood barrier including a bend relief and one or more location features to position the sterile blood barrier;

a gripper configured to be engaged with each of a penetrating member;

a drive assembly coupled to the cartridge; and

a member for moving the cartridge to bring an unused penetrating member into position for launch, the member clearing the gripper and drive assembly to lift the gripper and drive assembly clear so that the cartridge can rotate.