DIAGNOSTIC DEVICE

• US 20130253289A1
• Filed: 09/16/2011
• Published: 09/26/2013
• Est. Priority Date: 10/04/2010
• Status: Active Grant

• Current Assignee: PharmaSens AG
• Original Assignee: Hansjorg Tschirky, Paul Hadvary
• Inventors: Hadvry, Paul, Tschirky, Hansjrg
• Granted Patent: US 10,420,488 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150709 semi-automatically removed, i.e. before puncturing the protection is removed by a mechanism initiated by a deliberate action by the user, such as pressing a button
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An improved diagnostic analyte monitoring device has partially retractable hollow guide needles for the intradermal placement of diagnostic elements fixedly connected to measuring means within this device obviating the need to remove the guide needle and to connect the diagnostic elements to measuring means after placement into the skin. A flexible surface adhering to the skin serves for the subcutaneous implantation of the diagnostic elements within the guide needles and partial retraction of the guide needles exposes the active surface to body fluid, actuated by means designed for easy handling and safe operation. Concentration-time profiles of endogenous and exogenous analytes measured with the device are used to improve drug treatment modalities on an individualized basis.

Claims

1. A method for exposing an active surface of a diagnostic element to a body fluid for the measurement of a concentration of an analyte comprising a hollow guide needle for penetrating through a skin of a patient and housing the active surface, and connection lines to a measuring means of the diagnostic element, after insertion of the hollow guide needle, the hollow guide needle is only partially retracted, thereby exposing the active surface at a tip of the diagnostic element to the body fluid, without interfering with connections lines between the active surface, and the measuring means of the diagnostic element.

2. The method according to claim 1, wherein the diagnostic element is a microdialysis system containing a pumping system for the dialysate and a semi-permeable interface or dialysis membrane as active surface which is exposed to body fluid.

3. The method according to claim 1, wherein the concentration of an analyte in the dialysate is analysed online within the measuring device.

4. The method according to claim 1, wherein the dialysate is stored within the device by means minimizing mixing over time and is later removed for analysis of the concentration of the analyte.

5. The method according to claim 1, wherein the active surface is constituted by a sensor.

6. A device according to claim 5 containing a component with a flexible surface securing adherence of the active surface to the skin via an adhesive layer and a rigid part holding one or more diagnostic elements contained within one or more guide needles and means to position the flexible surface relative to the guide needles in such a way that in a first position the guide needles are concealed by the surface and in a second position the implantable part of the guide needles is exposed beyond the surface and a mechanism to bring the surface from the first to the second position.

7. The device according to claim 5, where the diagnostic element is fixedly positioned within the device.

8. The device according to claim 5, containing a sliding bolt mechanism being configured such that the insertion mechanism into the skin of the guide needles and their partial retraction are activated consecutively by a release element.

9. The device according to claim 8 where the release element activating the sliding bolt mechanism is a knob being configured such that pressing actuates the insertion mechanism of the guide needles into the skin and consecutive releasing the knob actuates the partial retraction of the guide needles and actuates the measurements.

10. The device according to claim 5, where the active surface and/or the conducting part of the diagnostic elements is flexible or has other characteristics which preclude secure placing into the skin without a guide needle.

11. The device according to claim 5, where the active surface of the diagnostic element has a diameter below 250 pm and an implantation depth of 1 to 5 mm and the guide needle is retracted by 1 to 3 mm.

12. The device according to claim 5, where the active surface of the diagnostic element contains a sensor.

13. The device according to claim 5, where the means for securing adherence to the skin is an adhesive layer for temporary wearing on the body, and the adhesive layer is fixed on the flexible surface of the device by a reduced surface in comparison to the adhesive surface adhering to the skin.

14. The device according to claim 5, where the device is applied to the skin using a functional package protecting the release and actuation elements of the device against unintended activation and having a rim pressing the adhesive layer towards the skin and securing its adhesion.

15. The device according to claim 5 containing a control and measuring means for a) surveying the correct functioning of the device, b) transforming sensor signals into analyte measurements, c) storing, displaying and transmitting analyte measurements online or batch-wise, and d) giving warning signals if analyte measurements are not within a predefined range.

16. The device according to claim 15 where the device further comprises a unit for delivery of injection fluid into the patient and analyte measurements are used for controlling the delivery of injection fluid.

17. The device according to claim 5 where the device is composed of a reusable part comprising all control elements and a disposable part comprising at least the elements for adhesion to the skin, the guide needle, and the active surface and conductive part of the diagnostic element.