Diagnostic device

• US 10,420,488 B2
• Filed: 09/16/2011
• Issued: 09/24/2019
• Est. Priority Date: 10/04/2010
• Status: Active Grant

• Current Assignee: PharmaSens AG
• Original Assignee: PharmaSens AG
• Inventors: Hadvary, Paul, Tschirky, Hansjorg
• Primary Examiner(s): Weare, Meredith
• Application Number:
  US13/877,480
• Publication Number:
  US 20130253289A1
• Time in Patent Office: 2,930 Days
• 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 at a tip of a diagnostic element of a dermally affixed sensor device to a body fluid for measurement of a concentration of an analyte, comprising:

inserting a hollow all-around closed guide needle of the dermally affixed sensor device into a patient'"'"'s skin using the dermally affixed sensor device, the hollow guide needle housing the active surface and at least one connection line to control and measuring circuitry of the diagnostic element, and the at least one connection line being fixedly positioned within the dermally affixed sensor device and rigid; and

after insertion of the hollow guide needle, retracting the hollow guide needle only partially into a casing of the dermally affixed sensor device by the hollow guide needle sliding over the at least one connection line to an extent sufficient for exposing the active surface at the tip of the diagnostic element to the body fluid, without a need to temporarily disconnect the at least one connection line between the active surface and the control and measuring circuitry of the diagnostic element.

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

3. The method according to claim 1, further comprising analyzing online the concentration of the analyte in a dialysate within the control and measuring circuitry.

4. The method according to claim 1, wherein the active surface includes a sensor.

5. The method according to claim 1, wherein the retracting the hollow guide needle includes sliding the hollow guide needle over the active surface and the at least one connection line that are fixedly positioned within the dermally affixed device.

6. The method according to claim 1, wherein the retracting the hollow guide needle includes at least a portion of the at least one connection line remaining housed in the hollow guide needle after the partial retraction of the hollow guide needle.

7. A dermally affixed sensor device for performing the method according to claim 1, comprising:

the casing;

an insertion mechanism within the dermally affixed sensor device comprising

a flexible surface attached to the casing configured to secure adherence of the device to the patient'"'"'s skin via an adhesive layer, the flexible surface including a first position in which the hollow guide needle is concealed by the flexible surface and a second position in which an implantable part of the hollow guide needle is exposed beyond the flexible surface;

a rigid structure in the casing that holds the diagnostic element including the active surface, the active surface being connected to the at least one connection line that is between the active surface and the control and measuring circuitry;

the hollow guide needle including an all-around around closed wall, wherein the active surface and the at least one connection line are housable in the hollow guide needle; and

an actuator to move the flexible surface from the first to the second position, wherein

the hollow guide needle, after being inserted, is only partially retractable into the casing by the hollow guide needle sliding over the at least one connection line to an extent sufficient for exposing the active surface at the tip of the diagnostic element to the body fluid, without a need to temporarily disconnect the at least one connection line between the active surface and the control and measuring circuitry of the diagnostic element.

8. The device according to claim 7, wherein the diagnostic element is fixedly positioned within the device.

9. The device according to claim 7, wherein the actuator includes a sliding bolt mechanism configured such that the move of the flexible surface from the first to the second position and the partial retraction of the hollow guide needle are activated consecutively by a release structure.

10. The device according to claim 9, wherein the release structure that activates the sliding bolt mechanism is a knob configured such that pressing the knob actuates the actuator which inserts the hollow guide needle into the patient'"'"'s skin, and consecutively releasing the knob partially retracts the hollow guide needle.

11. The device according to claim 7, wherein the active surface is flexible or is not suited to be placed into the patient'"'"'s skin without the hollow guide needle.

12. The device according to claim 7, wherein the active surface of the diagnostic element includes a diameter below 250 μ

m and is configured to be implanted at a depth of 1 to 5 mm in the patient'"'"'s skin, and the hollow guide needle is configured to be retracted by 1 to 3 mm.

13. The device according to claim 7, wherein the active surface of the diagnostic element includes a sensor.

14. The device according to claim 7, wherein the adhesive layer is configured for temporary wearing on a body, and is fixed on the flexible surface of the device by a reduced surface in comparison to the adhesive layer that is configured to adhere to the patient'"'"'s skin.

15. The device according to claim 7, wherein the device is configured to be applied to the patient'"'"'s skin using a functional package protecting release elements of the device against unintended activation and including a rim that presses the adhesive layer towards the patient'"'"'s skin and that secures its adhesion.

16. The device according to claim 7, further comprising the control and measuring circuitry configured to:

a) survey correct functioning of the device,

b) transform sensor signals into analyte measurements,

c) store, display, and transmit the analyte measurements online or batch-wise, and

d) give warning signals when the analyte measurements are not within a predefined range.

17. The device according to claim 7, wherein the device includes a reusable part comprising control elements and a disposable part comprising at least elements configured to adhere to the patient'"'"'s skin, the hollow guide needle, the active surface and the at least one connection line.

18. The device according to claim 7, wherein the hollow guide needle is slidable over the active surface and the at least one connection line that are fixedly positioned within the device.

19. The device according to claim 7, wherein the active surface is rigidly connected to the at least one connection line that is rigidly disposed between the active surface and the control and measuring circuitry.