US 2026/0047780 A1 · WEARABLE TRANSPLANTABLE TISSUE VIABILITY BIOSENSOR

Abstract

Disclosed are miniaturized, wearable microneedle biosensor devices, systems, and methods for measuring intradermal concentrations of various metabolites (including but not limited to lactate, pyruvate, and/or glucose) in order to directly assess the viability of living tissue (e.g., human or other mammalian soft tissue). In a variety of implementations, for example, the disclosed microneedle biosensor devices are self-contained in terms of power source, sample acquisition, measurement, and data transmission capabilities, e.g., allowing it to function autonomously once placed. In some implementations, for example, the disclosed microneedle biosensor devices can assess the viability of soft tissue (e.g., skin with or without fat, fascia, or muscle) during and after reconstructive surgery in which soft tissue is repositioned, rotated, or transferred to another site in the body (including but not limited to both microvascular free tissue transfer and regional pedicled flaps).

Claims22

Dependent claims

A method for assessing tissue viability during a tissue transplantation, the method comprising:

attaching a wearable sensor device comprising at least one microneedle having an electrochemical sensor electrode to detect an electrical signal from a reaction with a target analyte in a biofluid exposed to the at least one microneedle, wherein the wearable sensor device is attached to a tissue of an anatomic structure of a subject at an outer surface of the anatomic structure while at a first body location of the subject;
measuring a first intradermal concentration of at least one metabolite from the tissue at the first body location of the subject;
and
detaching at least a portion of the anatomic structure that includes the tissue with the attached wearable sensor device, thereby forming a detached body part with the wearable sensor device attached to the outer surface of the detached body part;
attaching the detached body part at a second body location of the subject;
and
measuring a second intradermal concentration of the at least one metabolite from the tissue at the second body location of the subject.

4 more elements

A method for assessing tissue viability during a tissue transplantation, the method comprising:

obtaining, from a wearable sensor device exposed to a biofluid in a tissue of a subject while the tissue is at a first body location of the subject, a first dataset comprising at least one intradermal concentration of one or more analytes from the tissue at the first body location of the subject;
obtaining, from the wearable sensor device exposed to the biofluid in the tissue of the subject while the tissue is at a second body location of the subject, a second dataset comprising at least one intradermal concentration of the one or more analytes from the tissue at the second body location of the subject, wherein, prior to obtaining the second data set, the tissue was detected from the first body location and transplanted at the second body location of the subject;
and
comparing, by a data processing unit configured to process data obtained from the wearable sensor device, the first dataset to the second dataset, wherein the comparing includes correlating temporal information in the first dataset and the second dataset to temporal stages of the tissue transplantation,
wherein the at least one intradermal concentration of the one or more analytes at the first body location of the subject and the at least one intradermal concentration of the one or more analytes at the second body location of the subject are measured by one or more microneedle electrochemical sensor electrodes of the wearable sensor device.

2 more elements

Dependencies are inferred from the claim text.

Wearable transplantable tissue viability biosensor

Life of this patent

Wearable transplantable tissue viability biosensor

Life of this patent

Abstract

Claims22