Sub-epidermal electric warning device

• US 10,149,974 B2
• Filed: 06/12/2013
• Issued: 12/11/2018
• Est. Priority Date: 06/25/2012
• Status: Active Grant

• Current Assignee: PharmaSens AG
• Original Assignee: PharmaSens AG
• Inventors: Hadvary, Paul, Tschirky, Hansjorg, Dinger, Rudolf, Michot, Jean-Pierre
• Primary Examiner(s): Gray, Phillip
• Application Number:
  US14/408,075
• Publication Number:
  US 20150174401A1
• Time in Patent Office: 2,008 Days
• Field of Search: 604111
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/688 using adhesives
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin

Abstract

A sub-epidermal electric warning device has electrodes penetrating through the patient'"'"'s epidermis and bipolar electric warning signals are transmitted to the sub-epidermal tissue by these electrodes. A device for surveillance of vital signs, analyte levels, or treatment parameters is using a sub-epidermal electric warning device for notifying the patient in situations requiring intervention.

Claims

1. A sub-epidermal electric warning device comprising:

electrodes to penetrate through a patient'"'"'s epidermis into a skin;

a generator of an electric warning signal which is transmitted to a sub-epidermal tissue by the electrodes, wherein an electric stimuli applied creates bipolar current pulses of alternating positive and negative polarity; and

an inserter to provide sub-epidermal insertion of the electrodes into the skin, wherein

the inserter is configured in such a way that in a ready-to-use position, the inserter keeps the skin away from contacting a tip of the electrodes which are fixedly positioned by a bottom of a casing of the device and, upon activation, pulls the skin towards the tip of the electrodes with a velocity to effect piercing of the skin and sub-epidermal insertion of the electrodes.

2. The sub-epidermal electric warning device according to claim 1, wherein the positive and negative pulses are following each other within 1 to 100 milliseconds and these pulse pairs follow each other in 0.2 to 5 seconds time.

3. The sub-epidermal electric warning device according to claim 1, wherein the electric warning signal is delivered with increasing intensity over time until the electric warning signal is recognized and confirmed by the patient.

4. The sub-epidermal electric warning device according to claim 3, wherein the electric warning signal is delivered with different rhythm for different warning messages.

5. The sub-epidermal electric warning device according to claim 1, wherein the generator includes control elements to generate the electric warning signal according to input signals.

6. The sub-epidermal electric warning device according to claim 5, further comprising at least one sensor system configured in such a way that when abnormal values for vital signs are measured by the at least one sensor system, the at least one sensor system transmits the input signals to the control elements to generate the electric warning signal.

7. The sub-epidermal electric warning device according to claim 6, wherein the at least one sensor system comprises subcutaneously implanted sensors to provide determination of analyte concentrations.

8. The sub-epidermal electric warning device according to claim 5, further comprising a pump system to provide subcutaneous fluid injection and configured in such a way that when functional abnormalities of the pump system occur, the pump system transmits the input signals to the control elements to generate the electric warning signal.

9. The sub-epidermal electric warning device according to claim 1, further comprising a skin attachment surface of the device coated with an adhesive layer to secure attachment to the skin.

10. The sub-epidermal electric warning device according to claim 9, wherein the adhesive layer to secure attachment to the skin is fixed on the skin attachment surface of the device by a reduced surface in comparison to a surface of the adhesive layer attached to the skin.

11. The sub-epidermal electric warning device according to claim 10, wherein the reduced surface of the adhesive layer fixed on a contact surface of the device results from a rim on the contact surface of the device to which the adhesive layer is not attached.

12. The sub-epidermal electric warning device according to claim 5, wherein the inserter comprises:

a skin attachment surface coated with an adhesive layer to secure attachment to the skin and including holes or recesses allowing passage of the electrodes;

a spring-type retraction mechanism of the skin attachment surface pulling the skin attachment surface together with the attached skin towards the tip of the electrodes;

a withholder to keep the retraction mechanism pre-stressed in the ready-to-use position such that the tip of the electrodes is concealed by the skin attachment surface and prevented to contact the skin;

a release and actuation element releasing blockage of the retraction mechanism by the withholder and actuating skin insertion of the electrodes by the relaxation of the retraction mechanism pulling the skin attached to the skin attachment surface against the tip of the electrodes, and actuating the control elements.

13. The sub-epidermal electric waning device according to claim 12, wherein the skin attachment surface is a rigid plate and the retraction mechanism is configured such that the retraction mechanism keeps the rigid plate and the bottom of the device casing parallel to each-other in the ready-to-use position and throughout retraction of the skin attachment surface towards the bottom of the device casing.

14. The sub-epidermal electric warning device according to claim 12, wherein the skin attachment surface is a flexible, segmented surface being attached to the bottom of the device casing at a periphery, and the retraction mechanism is configured such that in the ready-to-use position, the retraction mechanism stretches a central part of a contact surface away from the bottom of the device casing, forcing the skin attachment surface to form a cup or a gable.

15. The sub-epidermal electric warning device according to claim 14, wherein the retraction mechanism of the flexible, segmented surface makes use of springy elasticity of this surface to provide a rapid movement by relaxation from an enforced tense position.

16. The sub-epidermal electric warning device according to claim 1, wherein the device is composed of a reusable part comprising mainly control and additional electronic elements, and a disposable part comprising the other elements of the device.

17. A subcutaneous access device comprising the sub-epidermal electric warning device according to claim 1, wherein the sub-epidermal electric warning device is comprised in a functional package including a rim to press an outer rim of an adhesive layer towards the skin and protecting release and actuation elements of the sub-epidermal electric warning device against unintended activation.