NZ773584B2

NZ773584B2 - Measurement of susceptibility to diabetic foot ulcers

Info

Publication number: NZ773584B2
Application number: NZ773584A
Authority: NZ
Inventors: Sara Barrington; Martin F Burns; Graham O Ross
Original assignee: Bbi Medical Innovations Llc
Filing date: 2018-02-02
Publication date: 2025-10-29

Abstract

The present disclosure provides apparatus for for treating a diabetic foot ulcer in a patient. The apparatus comprises a sensor comprising a first electrode and a second electrode disposed on a shaped substrate. The sensor is configured to measure sub-epidermal moisture (SEM) values at respective locations of the patient’s skin during a SEM measurement period, and the shaped substrate is configured to conform to a portion of a foot of the patient. The measured SEM values correspond to levels of extracellular fluid (ECF) at the respective locations of the patient’s skin. The sensor is electrically insulated to allow only capacitive electrical contact with the patient’s foot. The apparatus also comprises third fourth electrodes on the shaped substrate and an external controller electrically connected to control the third and fourth electrodes to detect conductive contact with the patient’s skin during the SEM measurement period. The third and fourth electrodes apply a therapeutic stimulus to the patient during a therapeutic phase for periods having a time duration and a time interval between the periods, the therapeutic stimulus at a low level voltage or current to enhance healing of the diabetic foot ulcer.

Claims

WE CLAIM:

1. An integrated tus for treating a diabetic foot ulcer in a patient in need thereof, the apparatus comprising: a sensor comprising a first electrode and a second electrode disposed on a shaped substrate, wherein the sensor is configured to measure sub-epidermal moisture (SEM) values at respective locations of the patient’s skin during a SEM measurement , n the shaped substrate is configured to conform to a portion of a foot of the patient, wherein the measured SEM values correspond to levels of extracellular fluid (ECF) at the respective locations of the patient’s skin during the SEM measurement period, and wherein the sensor is electrically insulated by an insulating cover layer to allow only capacitive electrical contact with the patient’s foot; a third electrode and a fourth ode disposed on the shaped substrate; and an external controller electrically connected to the third electrode and the fourth electrode, wherein the external controller is configured to control the third and fourth odes to detect conductive contact with the patient’s skin during the SEM measurement period, and the al ller is configured to control the third and fourth electrodes to apply a eutic stimulus to the patient during a therapeutic phase, wherein the therapeutic stimulus is applied for periods having a time duration and a time interval between the periods, and wherein the therapeutic stimulus is a low level voltage or t to enhance healing of the diabetic foot ulcer.

2. The integrated apparatus of claim 1, further sing an absorbent pad.

3. The integrated apparatus of claim 1, further comprising a layer of adhesive.

4. The integrated apparatus of claim 1, wherein the shaped substrate is ble to gas while impervious to fluid.

5. The integrated apparatus of claim 4, wherein the SEM measurement period is during the time intervals.

6. The integrated apparatus of claim 1, further comprising a toroidal pad to relieve pressure on the diabetic foot ulcer in the patient. 46546416_1

7. The integrated apparatus of claim 1, wherein the external controller is periodically attached to the one or more sensors during the SEM measurement period to measure the SEM values.

8. The integrated apparatus of claim 1, further comprising a battery and wireless communication capability that enables the external controller to apply the therapeutic stimulus to the patient t a wired connection to the apparatus.

9. The integrated apparatus of claim 8, wherein the external controller is further enabled to communicate with the one or more sensors and to receive the measured SEM values wirelessly.

10. The integrated tus of claim 1, further comprising an integrated microcontroller configured to apply the therapeutic us and to measure the SEM values.

11. The integrated tus of claim 10, wherein the integrated microcontroller is configured to wirelessly transmit the measured SEM values.

12. The integrated apparatus of claim 1, wherein each of the time intervals is in the range of hours.

13. The ated apparatus of claim 1, wherein each of the time intervals is in the range of weeks.

14. The integrated apparatus of claim 1, wherein each of the time intervals is in the range of hours or weeks.

15. The integrated apparatus of claim 1, n the shaped substrate is a flexible ate. BBI Medical Innovations, LLC By the Attorneys for the Applicant SPRUSON & FERGUSON 46546416_1 AREA “A" E§§§§Ei$é$§ METATARSAL WEEGHTAPPLEEB 22 BYBQNE PHALANGE RESESTENG SHEAR FQRCE gé?" BQNE SHEAR FQRCE SKEN Q? SQLE APPLEED T0 SKIN C: G? F00? 38 24 RES§ST§NG CGMPRESSiCii‘é FGRCE A?PL§EB TGESKN TiMEG REGEON OFf SNCREASEB PRESSSRE iNCREASE 3N PRESSURE m TQRQEDAL AREA gamma LELCER 53 54 —————————— —_ ................. ismN : 24 iNETiAL ULSER {SNWRM RE 5f} APPLEEEBEELQQRISHQE REC-am <3?NX PRESSURE REGEON (3;: X ' ENCREASEDN