WO-2026093723-A1 - WEARABLE SENSING DEVICE

Abstract

A wearable sensing device for detecting at least one analyte, comprising a device body that is fixable to an application surface of a user, and a microneedle assembly connectable to the device body comprising a plurality of microneedles each comprising at least one electrode that is capable of generating an electrochemical response in the presence of at least one analyte, and at least one connection piercing element. The device body further comprises at least one elastomeric terminal and one or more electronic components in electrical connection therewith, wherein the at least one elastomeric terminal is electrically conductive and the at least one connection piercing element is insertable into the at least one elastomeric terminal so as to electrically connect the microneedle assembly bracket to the one or more electronic components.

Inventors

• LEWIS, Rachel Louise
• MURCHIE, Matthew
• CIRCI, Renato
• MICHALI, Rafael

Assignees

• SAVA Technologies Limited

Dates

Publication Date

20260507

Application Date

20251024

Priority Date

20241031

Claims (15)

1. 1. A wearable sensing device for detecting at least one analyte, comprising: a device body that is fixable to an application surface of a user; a microneedle assembly connectable to the device body comprising: a plurality of microneedles each comprising at least one electrode that is capable of generating an electrochemical response in the presence of at least one analyte; and at least one connection piercing element; wherein the device body further comprises at least one elastomeric terminal and one or more electronic components in electrical connection therewith, wherein the at least one elastomeric terminal is electrically conductive and the at least one connection piercing element is insertable into the at least one elastomeric terminal so as to electrically connect the microneedle assembly bracket to the one or more electronic components.
2. 2. A wearable sensing device according to claim 1, wherein the microneedle assembly comprises a microneedle assembly bracket from which the plurality of microneedles and the at least one connection piercing element extend.
3. 3. A wearable sensing device according to claim 2, wherein the at least one connection piercing element is parallel to each of the plurality of microneedles and extends from the microneedle assembly bracket in an opposing direction relative to each of the plurality of microneedles.
4. 4. A wearable sensing device according to any preceding claim, comprising one or more electrical tracks that electrically connect each of the plurality of microneedles with at least one of the at least one connection piercing elements.
5. 5. A wearable sensing device according to claim 4, wherein each of the plurality of microneedles is connected to two or more of the at least one connection piercing elements by the one or more electrical tracks.
6. 6. A wearable sensing device according to any of claims 1 to 3, wherein each of the plurality of microneedles comprises a substrate underlying: an insertion tip; and a microneedle body disposed between the insertion tip and the device body; wherein the substrate underlying the microneedle body comprises a first planar surface and a second planar surface opposing the first planar surface, and wherein at least one of the first planar surface and the second planar surface comprises at least one of the at least one electrodes.
7. 7. A wearable sensing device according to claim 6, wherein each of the first planar surface and the second planar surface comprises at least one of the at least one electrodes.
8. 8. A wearable sensing device according to claim 6 or 7, comprising a plurality of electrical tracks, wherein each of the plurality of electrical tracks electrically connects one of the at least one electrodes to one of the connection piercing elements.
9. 9. A wearable sensing device according to claim 8, wherein each of the plurality of electrical tracks is electrically isolated from the others of the plurality of electrical tracks.
10. 10. A wearable sensing device according to any of claims 6 to 9, wherein the distance between the first planar surface and the second planar surface of each microneedle defines a thickness T1 that is 0.2 mm or less.
11. 11. A wearable sensing device according to any of claims 6 to 9, wherein the distance between the first planar surface and the second planar surface of each microneedle defines a thickness T1 that is between 0.025 and 0.15mm between 0.025 mm and 0.5 mm, or between 0.025 mm and 0.4 mm, or between 0.05 mm and 0.20 mm, or between 0.075 mm and 0.100 mm, and is optionally about 0.025 mm, or about 0.05 mm, or about 0.075 mm, or about 0.10 mm.
12. 12. A wearable sensing device according to any preceding claim, wherein each of the at least one connection piercing elements comprises one or more barbs for engaging with the elastomeric terminal.
13. 13. A wearable sensing device according to claim 12, wherein each of the at least one connection piercing elements comprises a pair of barbs.
14. 14. A wearable sensing device according to any preceding claim, wherein the one or more electronic components comprises one or more processors and/or memory devices.
15. 15. A wearable sensing device according to any preceding claim, wherein the device body comprises a gasket arranged to support the at least one elastomeric terminal and/or inhibit water ingress.

Description

WEARABLE SENSING DEVICE TECHNICAL FIELD [0001] The present disclosure relates to a wearable sensing device for detecting at least one analyte. Aspects of the invention relate to a wearable sensing device, to an intermediate assembly for use in the manufacture of a wearable sensing device, and to a method of manufacturing a wearable sensing device. BACKGROUND [0002] Detecting and monitoring analyte concentrations in the human and animal body are widely recognized as critical metrics in various fields related to performance and disease management. For example, monitoring the concentration of analytes such as glucose and lactate, two key performance metrics, can allow a subject to predict exhaustion times, reduce the risk of injuries and maximise performance. In an alternative field, monitoring the concentration of an analyte such as glucose is of critical importance in the management of diseases such as diabetes mellitus. Diabetes results in an imbalance in glucose levels and can cause hyperglycemia or hypoglycemia. The imbalance in glucose levels typically arises from a lack of insulin production and/or insulin action, a hormone that regulates the level of glucose and is produced by the pancreas. A common practice in monitoring glucose concentration levels has been to employ devices such as blood glucose meters and continuous glucose monitors. Blood glucose meters are biosensors which are equipped with a needle, a lancet or the like and a measuring means in order to determine the glucose concentration in blood. This is typically achieved by acquiring a small drop of blood through pricking of the skin. The blood sample is subsequently placed onto a disposable test strip or similar measuring means in order to determine the glucose concentration in the blood of the subject. A continuous glucose monitor differs in a number of areas but most notably this technology measures glucose concentration in interstitial fluid, which is a thin layer of fluid surrounding cells in the body, as opposed to blood, as well as monitoring the glucose concentration continuously, rather than a one-off measurement. [0003] In spite of the advances in the technology of continuous glucose monitors, there are a number of drawbacks associated with this technology. In particular, such devices are only capable of measuring a single analyte, thereby limiting their versatility. All require an assistive hypodermic needle to enable sensor insertion, which is problematic for users who have a needle phobia or dislike and provides a poor user experience. Commercially available devices are typically expensive, thereby prohibiting access for many who would benefit from such devices. [0004] Many known devices have a large footprint in the skin. This can lead to trauma which gives rise to poor readings, especially in the first 6 to 48 hours of wear time. [0005] The sensors of many known devices can contact the muscular layer or nerve cells of the wearer when inserted, leading to discomfort and pain. Similarly, certain devices are known to have sensors that can cause damage to blood vessels and lead to bleeding. [0006] Many known devices sense in the subcutaneous region of the skin which gives rise to slower response times. [0007] Certain analyte sensing devices that utilise microneedles have been proposed but no such device has been demonstrated that provides desired levels of robustness, accuracy and reliability. Consequently, no such device has yet reached market readiness. [0008] In view of the above, there is a need for an analyte monitoring device which is minimally invasive, mechanically stable and biocompatible in a range of different physiological environments. [0009] Aspects of the present invention were devised with the foregoing in mind. BRIEF SUMMARY [0010] In accordance with an aspect of the present invention, there is provided a wearable sensing device for detecting at least one analyte, comprising: a device body that is fixable to an application surface of a user; a microneedle assembly connectable to the device body comprising: a plurality of microneedles each comprising at least one electrode that is capable of generating an electrochemical response in the presence of at least one analyte; and at least one rearward facing protrusion; wherein the device body further comprises at least one pogo pin and one or more electronic components in electrical connection therewith, wherein the at least pogo pin is electrically conductive and the at least one rearward facing protrusion is engageable with (e.g. by abutment) the at least one pogo pin so as to electrically connect the microneedle assembly bracket to the one or more electronic components. [0011] In accordance with an aspect of the present invention, there is provided a wearable sensing device for detecting at least one analyte, comprising: a device body that is fixable to an application surface of a user; a microneedle assembly connectable to the device body comprising: a plurality