Body fluid sampling module with a continuous compression tissue interface surface

• US 20110077478A1
• Filed: 11/09/2010
• Published: 03/31/2011
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Molho, Joshua, Deshmukh, Ajay, Perry, Jeffrey, Wang, Amy, Eaton, Brent, Shoup, Thomas, Hegener, Jason, Freeman, Dominique
• Granted Patent: US 9,226,699 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150061 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 5/15146 : 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 5/15178 : 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

Abstract

A body fluid sampling device includes a housing, a penetrating member positioned in the housing and a test strip. A compliant front end is coupled to the housing. The compliant front-end includes a rigid member with an interior aperture to receive the body fluid from a wound site.

Claims

1. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing;

a test strip or a test sensor;

a compliant front end coupled to the housing, the compliant front-end including a rigid member with an interior aperture to receive the body fluid from a wound site.

2. The device of claim 1, wherein the complaint front end is configured to have a user push its finger of the front end and in response to a force of at least 2N to 12N body fluid flows to the test strip.

3. The device of claim 1, wherein a height of compliant front end and material properties of the complaint front end are set such that fingers of a size which represent 95% of the population would need to push with at least 10N of force to touch the test strip.

4. The device of claim 1, wherein a range of finger sizes would put no more than 1N of force on the test strip while being within at least 300 μ

m of the active area of the test strip.

5. The device of claim 1, wherein feedback is given to a user in a go/no-go fashion to indicate that the user has pushed its finger against the compliant front end with at least 10N of force.

6. The device of claim 5, wherein the feedback is selected from at least one of, visual, aural, tactile and a combination thereof.

7. The device of claim 1, wherein feedback is given to the user in a go/no-go fashion to the user to indicate that the user has touched the test strip with less than 1N of force.

8. The device of claim 1, wherein the test strip is coupled to a test strip holder mounted on at least one of, a spring, elastic support and other movable support, such that if a force of 1N is applied to the test strip then the test strip moves away from the finger limiting the applied force on the test strip to less than 1N.

9. The device of claim 1, wherein a user manually initiates lancing and testing after force and finger-position thresholds are met.

10. The device of claim 1, wherein lancing and testing are automatically initiated once force and finger-position thresholds are met.

11. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing;

a test strip;

a front end coupled to the housing, the front end including finger position feedback.

12. The device of claim 11, wherein the finger position feedback includes at least one electrode placed around at least one electrode positioned adjacent to an aperture on the test strip through which a finger is lanced.

13. The device of claim 12, wherein the finger position feedback includes a plurality of electrodes equally spaced around the aperture on the test strip.

14. The device of claim 13, wherein capacitance of the plurality of electrodes is measured for the finger position feedback.

15. The device of claim 11, wherein the feedback includes a light pair to indicate good and bad position.

16. The device of claim 11, wherein the feedback includes a plurality of light pairs to indicate which direction a finger should be moved to improve positioning and then signaling good position.

17. The device of claim 11, wherein the feedback includes at least one electrode that is also a heat sink to minimize a temperature change of the test strip due to heat transfer from the finger.

18. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing coupled to an electronic driver;

feedback control that provides a penetrating member depth setting based on feedback information derived at the time of a lancing and an optimized protocol stored in a processor and derived based on knowledge of a skin microvasculature.

19. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing coupled to an electronic driver;

a finger position sensor;

a processor that includes historical penetration data of a user; and

a display coupled to the processor that displays a finger position relative to the finger position sensor to indicate a target marker.

20. The device of claim 19, wherein a target marker is updated based on measurements achieved from previous failed and successful measurements.

21. The device of claim 20, wherein multiple targets can be displayed for different fingers/sites.

22. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing coupled to an electronic driver;

a finger position sensor;

a processor that includes historical penetration data of a user; and

a display coupled to the processor that displays a finger position in response to a measured value as a finger approaches the finger position sensor, wherein previous failed and successful measurement attempts are plotted with position corresponding to the measured value.

23. The device of claim 22, wherein the display instructs a user to position the finger position in a region with a highest number of successful historical measurements.

24. The device of claim 23, wherein the processor filters the historical data based on finger/site.

25. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing;

a front end coupled to the housing that includes a rigid structure and an aperture to allow the flow of the body fluid through the front end, the front end being configured to provide that movement of the front end aperture is constrained to a direction parallel to a direction of applied finger pressure to the front end.

26. A body fluid sampling device, comprising:

a housing;

a penetrating member positioned in the housing;

a front end coupled to the housing with a deformable portion covering a rigid portion with apertures provided therein that allow for flow of the body fluid, wherein the rigid portion applied a downward force to the deformable portion with the deformable portion distributing reaction forces from the rigid portion evenly around the front end.

27. The device of claim 26, wherein the reaction forces create a pressure profile within a skin vasculature in an area of a penetrating member wound so that a body fluid sample is automatically expressed.

28. The device of claim 27, wherein the deformable portion allows the device to accommodate a wide variety of body part geometries and sizes.