Cardiac monitoring apparatus for wearable and implantable use

Abstract

Embodiments of the present invention relates to an apparatus for monitoring cardiovascular diseases comprising an implantable mechanical sensor (1) for detecting strain levels of a heart; an implantable or wearable microneedle-based chemical sensor (2) for detecting level of cardiac biomarkers such as troponin; at least a wireless communication unit for transmitting the mechanical sensor (1) and / or chemical sensor (2) readings.

Description

[0001] 21644.81

[0002] CARDIAC MONITORING APPARATUS FOR WEARABLE AND

[0003] IMPLANTABLE USE

[0004] Field of the Invention

[0005] The present invention pertains to an apparatus equipped with both chemical and mechanical sensors designed for cardiovascular disease monitoring. This versatile device, suitable for both wearable and implantable use, is capable of detecting cardiac biomarkers such as troponin from interstitial fluid and measuring strains in epicardial tissue.

[0006] Background of the Invention

[0007] Cardiovascular diseases (CVDs) are a significant health issue and the primary cause of mortality worldwide. Cardiovascular diseases (CVDs), such as heart attack and cardiac insufficiency, are chronic conditions that develop due to the gradual buildup of underlying health issues in the body. Therefore, it is crucial to closely monitor the ongoing issues that contribute to cardiovascular diseases in order to prevent fatalities. Heart attacks often result from the obstruction of the coronary arteries, which are responsible for delivering blood to the heart. Plaque, a buildup of fatty substances, accumulates inside the artery, causing a reduction in the artery's diameter and eventually leading to the formation of a blockage. Insufficient blood supply to the heart causes the heart muscle to undergo necrosis, resulting in the release of a specific proteins such as cardiac troponin (cTnl, cTnT), creatine kinease (CK-MB), myglobin, B-type Natriuretic Peptide (BNP), N-terminal pro b-type Natriuretic Peptide (NT-proBNP), and C-reactive Protein (CRP).

[0008] There are several methods to monitor the CVDs progression of a patience. One of the methods is based on aforementioned cardiac troponin (cTnl). Recent research has devised many techniques to detect the presence of cardiac troponin in the blood, such as optical, chemical, or Raman spectroscopy. However, because blood analysis provides only single-time data, it hinders the real-time monitoring of cardiac troponin and, consequently, cardiovascular diseases (CVDs). 21644.81

[0009] Another approach involves using echocardiography to monitor the structural abnormalities of the hearth. Echocardiography necessitates the expertise of a trained individual within a hospital setting, making it impractical for real-time monitoring of cardiovascular diseases. Strain sensors are commonly used to monitor structural problems following cardiac surgery. Nevertheless, strain sensors are susceptible to the harmful mechanical impact of the surrounding tissues of the heart. The strain sensor's readings are rendered unreliable due to the substantial alterations caused by the movements and / or pressures exerted by the surrounding tissues of the heart.

[0010] Given the limitations of existing technologies for monitoring cardiovascular diseases (CVDs), there is a requirement for a device that is capable of specifically monitoring CVDs in real-time.

[0011] Brief Description of the Drawings

[0012] An exemplary embodiment of the present invention is depicted in the accompanying drawings for better understanding. The usage of the invention will be more apparent when examined in accordance with the detailed description, where similar elements are denoted by similar to reference numbers. The following figures provide further details:

[0013] Figure 1 is a schematic view of the chemical sensor showing a microneedle array with interdigitated electrodes for impedimetric sensor through an array of needle in one exemplary embodiment of the present invention.

[0014] Figure 2 is a schematic view of the mechanical sensor showing the soft layer, interdigitated electrodes and hard layer in one exemplary embodiment of the present invention. 21644.81

[0015] Figure 3a is a schematic view of the chemical sensor attached to an electronic board for wearable device that is capable of wireless data transmission.

[0016] Figure 3b is a schematic view of the chemical and mechanical sensors attached to an electronic board for implantable device that is capable of wireless data transmission.

[0017] The elements illustrated in the figures are numbered as follows:

[0018] 1. Mechanical sensor

[0019] 1.1. Soft layer

[0020] 1.2. Interdigitated electrodes

[0021] 1.3. Hard layer

[0022] 2. Microneedle -based chemical sensor

[0023] 2.1. Contact layer

[0024] 2.2. Needle

[0025] Detailed Description

[0026] Embodiments of the present invention relates to an apparatus for monitoring cardiovascular diseases comprising a mechanical sensor (1) for detecting strain levels of a hearth wherein the mechanical sensor (1) comprises a soft layer (1.1) having a stiffness preferably between IkPA -10 MPa providing that the soft layer (1.1) stretches together with an epicardial tissue to which one surface of the soft layer ( 1.1 ) is attached, at least one interdigitated electrodes (1.2) inside the soft layer (1.1) for detecting the strain of the soft layer (1.1), a hard layer (1.3) on the other side of the soft layer (1.1) having a stiffness preferably between IkPA -10 MPa providing that the soft layer (1.1) is not stretched by pressures exerting towards the other side of the soft layer (1.1); an implantable or wearable microneedle-based chemical sensor (2) for detecting cardiac biomarkers such as troponin level wherein the microneedle-based chemical sensor (2) comprises an interdigitated electrode layer (2.1) comprising an array of electrically conductive needles (2.2) preferably with an array size (number of needles) ranging from 1 x 2 to 20 x 20 for attaching to a tissue in order to contact interstitial fluid, at least one electronic component for 21644.81 detecting impedimetrice (capacitance or resistive) change between needle (2.2) tips which is corelated with cardiac biomarkers’ (such as troponin) level within the interstitial fluids; at least one wireless communication unit for transmitting the microneedle-based chemical sensor (1) and / or mechanical sensor (2) readings.

[0027] In the embodiments of the invention, readings of the mechanical sensor (1) and chemical sensor (2) gives valuable information for critical conditions for the heart. In one hand, any abnormal strain on heart can be detected by the mechanical sensor (1) reads. On the other hand, any abnormal release of a specific biomarker which is cardiac troponin for hearth problem can be detected by the chemical sensor (2).

[0028] The mechanical sensor (1) comprises a soft layer (1.1), interdigitated electrodes (1.2) and a hard layer (1.3). One surface of the soft layer (1.1) is suitable for attaching to patience epicardial tissue. The other surface of the soft layer (1.1) is attached to the hard layer (1.3). The soft layer (1.1) has a selected stiffness providing that the soft layer (1.1) can be able stretch in accordance with the attached epicardial tissue. The interdigitated electrodes (1.2) are positioned inside the soft layer (1.1). The interdigitated electrodes (1.2) are able to stretch with the soft layer

[0029] (1.1). Thus, when the soft layer (1.1) is stretched by the epicardial tissue, space between the interdigitated electrodes (1.2) is changed. The change in space between the interdigitated electrodes (1.2) alters the capacitance value of the interdigitated electrodes (1.2) which is proportional the stretch of the soft layer (1.1) and also the strain of the epicardial tissue. The capacitance value of the interdigitated electrodes

[0030] (1.2) can be read by an electronic component or directly by the wireless communication unit. The hard layer (1.3) is positioned to the other surface of the mechanical sensor (1). The hard layer (1.3) has a stiffness providing that the soft layer (1.1) is not stretched by pressures exerting towards the other side of the soft layer (1.1). In this way, the hard layer (1.3) prevents the soft layer (1.1) from the pressure of the peripherals such as pressures resulting from heart beating or breathing. So, the reliability and validity of the strain level detection are ensured. In one embodiment of the invention, the soft layer (1.1) thickness preferably 21644.81 between 1 m -1mm to the hard layer (1.3) thickness ratio is selected such that the soft layer (1.1) is not stretched by pressures exerting towards the other side of the soft layer (1.1).

[0031] In the embodiments of the invention, the chemical sensor (1) comprises a contact layer (2.1) which comprises an array of electrically conductive needles (2.2). Form of the electrically conductive needles (2.2) is suitable for attaching to a tissue. The tissue may be the epicardial tissue for the implantable chemical sensor (2) and a skin tissue for the wearable chemical sensor (2). The form such as rigidity, size and length of the needles (2.2) are determined according to tissue type and the chemical sensor (2) type is implantable or wearable. In one embodiment of the invention the needles (2.2) are in a form of microneedles. The microneedles (2.2) have interdigitated metal electrodes for impedimetric sensing. In another embodiment, microneedles (2.2) have holes for collecting interstitial fluid outside the skin or organ. The extracted ISF is collected in a chamber with chemical sensor (2) capable of identifying level of cardiac biomarkers.

[0032] In one embodiment of the invention, the cardiac troponin is cTnl and / or cTnT and other biomarkers are creatine kinease (CK-MB), myglobin, B-type Natriuretic Peptide (BNP), N-terminal pro b-type Natriuretic Peptide (NT-proBNP), and C- reactive Protein (CRP).

[0033] In one embodiment of the invention, the apparatus is made from biocompatible materials.

[0034] In one embodiment of the invention, the mechnanical sensor (1), the implantable chemical sensor (2) and wireless communication unit is made from biodegradable materials. So, the mechanical sensor (1), the implantable chemical sensor (2) and wireless communication unit are degraded in body environment over a specific time span. In an alternative version of this embodiment, biodegradable materials are able triggered (start of the bio degration) by a light or sound wave. 21644.81

[0035] In one embodiment of the invention, the soft layer (1.1) and the hard layer (1.3) is made from polymeric materials.

[0036] In one embodiment of the invention, the soft layer (1.1) is made from an elastomer.

[0037] In one embodiment of the invention, the soft layer (1.1) is made from polydimethylsiloxane.

[0038] In one embodiment of the invention, wireless communication unit comprises an antenna and electronic circuit or a battery. In the embodiment comprising a battery, the mechanical sensor (1) and / or chemical sensor (2) can be powered by the battery.

[0039] In one embodiment of the invention, wireless communication unit is in the form of wifi, Bluetooth, zigbee, NFC or RFID communication units. In the embodiment comprising NFC or RFID communication unit, the mechanical sensor (1) and / or chemical sensor (2) can be powered by inductive coupling.

[0040] One embodiment of the invention comprises a receiver unit for receiving the readings of the mechanical sensor (1) and / or chemical sensor (2) from the wireless communication unit of the apparatus. The receiver unit may be in a form of mobile device such as cellphone, smartphone or tablets.

[0041] One embodiment of the invention comprises a processing unit adapted to run a method for diagnose a cardiovascular disease according to the mechanical sensor (1) and chemical sensor (2) readings.

Claims

1. 21644.81CLAIMS1. An apparatus for monitoring cardiovascular diseases comprising a mechanical sensor (1) for detecting strain levels of a hearth wherein the mechanical sensor (1) comprises a soft layer (1.1) having a stiffness providing that the soft layer (1.1) stretches together with an epicardial tissue to which one surface of the soft layer (1.1) is attached, interdigitated electrodes (1.2) inside the soft layer (1.1) for detecting the strain of the soft layer (1.1), a hard layer (1.3) on the other side of the soft layer (1.1) having a stiffness providing that the soft layer (1.1) is not stretched by pressures exerting towards the other side of the soft layer (1.1); an implantable or wearable microneedle-based chemical sensor (2) for detecting cardiac troponin level wherein the microneedle-based chemical sensor (2) comprises a contact layer (2.1) comprising an array of electrically conductive needles (2.2) for attaching a tissue in order to contact interstitial fluid, at least one electronic component for detecting impedance (capacitance or resistance) change between needle (2.2) tips which is correlated with cardiac troponin level of the interstitial fluids; at least a wireless communication unit for transmitting the mechanical sensor (1) and / or chemical sensor (2) readings.

2. An apparatus for monitoring cardiovascular diseases according to claim 1, wherein the cardiac troponin is cTnl and / or cTnT and other biomarkers are creatine kinease (CK-MB), myglobin, B-type Natriuretic Peptide (BNP), N- terminal pro b-type Natriuretic Peptide (NT-proBNP), and C-reactive Protein (CRP).

3. An apparatus for monitoring cardiovascular disease according to claim 1, wherein the microneedles (2.2) comprise holes for receiving fluid and chemical sensor located at the backside of the microneedles (2.2).21644.

814. An apparatus for monitoring cardiovascular disease according to claim 1, wherein the chemical sensor (2) comprises multiple chemical detection sites for multiplexed detection.

5. An apparatus for monitoring cardiovascular diseases according to any of the preceding claims, wherein the apparatus is made from biocompatible materials.

6. An apparatus for monitoring cardiovascular diseases according to any of the preceding claims, wherein the mechanical sensor (1) and the implantable chemical sensor (2) is made from biodegradable materials.

7. An apparatus for monitoring cardiovascular diseases according to claim 5 or 6, wherein biodegradable materials is able triggered by a light or sound wave.

8. An apparatus for monitoring cardiovascular diseases according to any of the preceding claims, wherein the soft layer (1.1) and the hard layer (1.3) is made from polymeric materials.

9. An apparatus for monitoring cardiovascular diseases according to any of the preceding claims, wherein the soft layer (1.1) is made from an elastomer.

10. An apparatus for monitoring cardiovascular diseases according to claim 9, wherein the soft layer (1.1) is made from poly dimethylsiloxane.

11. An apparatus for monitoring cardiovascular diseases according to any of the preceding claims, wherein the soft layer (1.1) thickness to the hard layer (1.3) thickness ratio is selected such that the soft layer (1.1) is not stretched by pressures exerting towards the other side of the soft layer (1.1).21644.8112. An apparatus for monitoring cardiovascular diseases according to any of the preceding claims, wherein wireless communication unit comprises an antenna and electronic circuit or a battery.

13. An apparatus for monitoring cardiovascular diseases according to any of the preceding claims, wherein wireless communication unit is in the form of wifi, Bluetooth, zigbee, NFC or RFID communication units.

14. A receiving unit for receiving the readings of the mechanical sensor (1) and / or chemical sensor (2) from the wireless communication unit of the apparatus according to any one of the preceding claims.

15. A processing unit adapted to run a method for diagnose a cardiovascular disease according to the mechanical sensor (1) and chemical sensor (2) readings of the apparatus according to any one of the preceding claims.

16. An apparatus for monitoring cardiovascular diseases according to Claim 1, wherein the number of needles are ranging from 1 x 2 to 20 x 20.

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