Method and apparatus for a fluid sampling device

• US 20100286560A1
• Filed: 06/03/2005
• Published: 11/11/2010
• Est. Priority Date: 06/03/2004
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Schulte, Tom, Alden, Don, Freeman, Dominique, Schumann, Matt, Cane, Michael
• Granted Patent: US 9,820,684 B2
• 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 5/150152 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. fluid sampling device comprising:

a housing;

a slider located on a surface of said housing, said slider movable in a linear direction to rotate said cartridge to bring an unused penetrating member into position for use.

3. The device of claim 1 wherein said cam surface is aligned parallel to said slider.

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

5. The device of claim 1 wherein cam surface comprise a linear strip of material with at least two raised portions and two depressed portions.

2. A fluid sampling device comprising:

a housing;

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

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

a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of the longitudinal openings, wherein the sterility barrier covering the lateral openings is configured to be moved so that the elongate portion may be accessed by the gripper without touching the barrier; and

a slider located on a surface of said housing, said slider movable in a linear direction to rotate said cartridge to bring an unused penetrating member into position, for use;

a tooth gear coupled to said slider to control a distance said slider can travel;

a follower coupled to said slider;

a cam surface engaged by said follower to lift said cartridge a desired distance above a first position to allow for rotation of the cartridge without engaging a gripper used to advance the penetrating member.

6. A device for use in penetrating tissue to obtain a body fluid sample, comprising:

a cartridge; and

a plurality of penetrating members slidably coupled to the cartridge, each of said penetrating members having a distal end sufficiently sharp to pierce tissue and each of said penetrating members being moveable relative to the other ones of the penetrating members, so that the distal end of the respective penetrating member is movable to penetrate tissue;

wherein each of said penetrating member is a bare lancet does not penetrate an outer sterility barrier during actuation.

7. 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, 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.

8. The device of claim 7 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.

9. A device comprising:

a housing;

a penetrating member driver;

a cartridge containing a plurality of penetrating members;

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 the linear motion of the slider to rotate the cartridge, punch open a new cavity and load a new penetrating member.

10. A method of indexing comprising:

moving a linear slider;

said linear slider coupled to a rod;

said rod moving with said slider, said rod having at least one roller

using the linear motion of the slider and linear motion of the rod to push at least one linear slider and to roll a roller along a linear cam surfaces to lift clear a drive assembly, rotate the cartridge, punch open a new cavity and load a new penetrating member.

11. A fluid sampling device comprising:

a housing;

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

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

a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of the longitudinal openings, wherein the sterility barrier covering the lateral openings is configured to be moved so that the elongate portion may be accessed by the gripper without touching the barrier; and

a replaceable tissue interface barrier located on said housing, wherein said interface is replaced after each lancing event to prevent fluid contamination between different users.

12. The device of claim 11 wherein said replaceable tissue interface is positioned about an opening on said housing where said penetrating members extend outward to engage tissue on a user to obtain a fluid sample.

13. The device of claim 11 wherein each of said cavities further include a lateral opening.

14. The device of claim 11 wherein said replaceable tissue interface comprising a plurality of individually removable sheets of material, wherein one sheet is removed prior to each lancing event to uncover a sterile unused sheet to provide an uncontaminated surface for the next user to use.

15. A device for use in penetrating tissue to obtain a body fluid sample, comprising:

a cartridge; and

a plurality of penetrating members slidably coupled to the cartridge, each of said penetrating members having a distal end sufficiently sharp to pierce tissue and each of said penetrating members being moveable relative to the other ones of the penetrating members, so that the distal end of the respective penetrating member is movable to penetrate tissue;

wherein each of said penetrating member is a bare lancet does not penetrate an outer, removable sterility barrier during actuation.

16. 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, 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.

17. The device of claim 16 further comprising a fluid contamination barrier located on a housing said device, said barrier being removed and replaced by a clean barrier prior to each lancing event.

18. A method for obtaining a fluid sample comprising:

removing the protective covering from the packaging exposing a single item of sterile barrier film by pulling on the tab provided;

pressing the sterile barrier film to the front and underside of the case;

preparing a penetrating member by operating the slider on the side of the device and depressing the fire button once;

pressing the center circular cutout in the foam front of the barrier film against the patients skin in the area to be lanced;

lancing the patient;

removing the barrier film from the front of the device;

and checking that outer case of device has not been contaminated by blood and if necessary clean it with disinfectant.

19. A method for obtaining a fluid sample comprising:

preparing the skin of the patient in the area to be lanced with a sterile wipe;

removing the protective covering from the packaging exposing a single item of sterile barrier film by pulling on the tab provided;

removing the sterile barrier film from the carrier by pulling on the applicator tab provided;

applying the adhesive side to the front area of the device ensuring that both the outer circular holes in the barrier film fit around the matching circular bosses on the front of the device;

pressing the sterile barrier film to the front and underside of the case taking care not to touch the firing area of the barrier film;

preparing a penetrating member by operating the slider on the side of the device and depressing the fire button once;

pressing the center circular cutout in the foam front of the barrier film against the patients skin in the area to be lanced;

lancing the patient by depressing the fire button a second time;

removing the device from the patients skin and take the blood sample from their skin;

removing the barrier film from the front of the device using the tab provided and dispose of it properly; and

checking that outer case of device has not been contaminated by blood and an it with disinfectant.

20. A fluid sampling device, comprising:

a housing;

a slider located on a surface of said housing, said slider movable in a linear direction to rotate said cartridge to bring an unused penetrating member into position for use;

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

a plurality of penetrating members at least partially contained in said cavities of the cartridge and extendable through openings in the cartridge;

a sterility barrier coupled to said cartridge, said sterility barrier covering a plurality of the openings, and

a disposable blood barrier positionable on the housing,

21. The device of claim 20, wherein said the disposable blood barrier is replaced for each of a new patient.

22. The device of claim 21, wherein the disposable blood barrier is placed between the device and the patient.

23. The device of claim 21, wherein the disposable blood barrier is used to prevent contamination of any part of the device that can be a pathway for transmission of pathogens between patients.

24. The device of claim 20, further comprising:

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

25. A method of indexing comprising:

providing a fluid sampling device that includes a housing, a slider located, a plurality of penetrating members, a plurality of analyte sensing members and a disposable blood barrier positionable on the housing;

moving the linear slider;

said linear slider coupled to a rod;

said rod moving with said slider, said rod having at least one roller using the linear motion of the slider and linear motion of the rod to push at least one linear slider and to roll a roller along a linear cam surfaces to lift clear a drive assembly, rotate the cartridge, punch open a new cavity and load a new penetrating member; and

using the disposable blood barrier to prevent contamination of any part of the device that can be a pathway for transmission of pathogens between patients.

26. The method of claim 25, 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.