TWI858821B - Swallow sensing device and swallow sensing system - Google Patents

Abstract

A swallow sensing device includes a first flexible piezoelectric element, a flexible substrate, a first conducting lead and a second conducting lead. The first flexible piezoelectric element includes a first flexible piezoelectric layer, a first flexible electrode and a second flexible electrode. The first and second flexible electrodes are respectively located on opposite sides of the first flexible piezoelectric layer. The first flexible piezoelectric layer and the first and second flexible electrodes are encapsulated in the flexible substrate. The first conducting lead extends from the inside of the flexible substrate to the outside of the flexible substrate, and one end of the first conducting lead is connected with the first flexible electrode. The second conducting lead extends from the inside of the flexible substrate to the outside of the flexible substrate, and one end of the second conducting lead is connected with the second flexible electrode.

Description

Swallowing sensing device and swallowing sensing system

The present invention relates to a swallowing sensing device and a swallowing sensing system.

Major developed countries around the world generally have an aging society trend, such as Japan, Taiwan, Europe and North American countries. One of the common diseases among the elderly is dysphagia. If the elderly are not careful when eating and drinking, they are prone to coughing due to dysphagia. In severe cases, they may suffer from pneumonia or suffocation, which is a considerable burden on care. In addition, in order to diagnose the symptoms of dysphagia, large equipment in the hospital is usually required for diagnosis. The medical system and patients often feel heavy burdens due to waiting and date scheduling. Therefore, there is an urgent need for a swallowing sensor device that can detect and monitor in real time and has excellent wear comfort.

One object of the present invention is to provide a swallowing sensing device that can provide excellent wearing comfort for a subject or patient and significantly reduce the discomfort of the subject. Therefore, the swallowing sensing device according to certain embodiments of the present invention is more suitable for long-term monitoring of the swallowing process of the subject.

According to an embodiment of the present invention, a non-invasive wearable device can be provided to monitor in real time whether the swallowing action of the subject or patient is complete. In today's aging society, the elderly suffer from dysphagia due to diseases such as stroke, Parkinson's disease, or Alzheimer's disease. The swallowing sensing device disclosed herein has excellent flexibility and compliance, and can be directly attached to the skin surface of the hyoid bone and thyroid cartilage in the throat to monitor in real time the changes in the body surface morphology caused by the movement of the hyoid bone and thyroid cartilage during the swallowing process, so that it can accurately analyze and judge whether the swallowing action is completed. This swallowing sensing device can also be used in combination with a breathing sensor to more accurately judge the swallowing action.

In this specification, different implementations or examples may have different or the same technical effects, so any implementation (or example) of the present invention does not need to achieve all the purposes, advantages, or features disclosed in this invention. The advantages, applications, or features of certain implementations of the present invention described above are to facilitate the understanding and application of the implementations of this disclosure by those skilled in the art to which the present invention belongs, and are not intended to limit the scope of the present invention.

The swallowing sensing device disclosed herein is used to be attached to the skin surface of the moving area of the hyoid bone and/or thyroid cartilage of a subject. The swallowing sensing device includes a first flexible piezoelectric element, a flexible substrate layer, a first wire and a second wire. The first flexible piezoelectric element includes a first flexible piezoelectric layer, a first flexible electrode and a second flexible electrode. The first flexible electrode and the second flexible electrode are respectively located on opposite sides of the first flexible piezoelectric layer. The flexible substrate layer covers the first flexible piezoelectric layer, the first flexible electrode and the second flexible electrode. The first wire extends from the inside of the flexible substrate layer to the outside of the flexible substrate layer, and one end of the first wire is connected to the first flexible electrode. The second wire extends from the inside of the flexible substrate layer to the outside of the flexible substrate layer, and one end of the second wire is connected to the second flexible electrode.

In some embodiments, the swallowing sensing device further includes an adhesive layer disposed on a lower surface of the flexible substrate layer.

In some embodiments, the swallowing sensing device further comprises a first flexible patch and a second flexible patch. The first flexible patch is disposed on an upper surface of the flexible substrate layer and extends beyond a first side of the flexible substrate layer. The second flexible patch is disposed on the upper surface and is spaced apart from the first flexible patch by a distance, and the second flexible patch extends beyond a second side of the flexible substrate layer, and the first side is opposite to the second side.

In some embodiments, the swallowing sensing device further includes a flexible patch covering an upper surface of the flexible substrate layer, and the flexible patch extends beyond two opposite sides of the flexible substrate layer.

In some embodiments, in a direction perpendicular to the upper surface, the first flexible patch and the second flexible patch do not overlap with the first flexible piezoelectric layer.

In some embodiments, a horizontal distance between the first flexible patch and the first flexible piezoelectric layer is about 5 mm to about 10 mm, and a horizontal distance between the second flexible patch and the first flexible piezoelectric layer is about 5 mm to about 10 mm.

In some embodiments, the first flexible patch and the second flexible patch each have a main elastic stretch direction, and the main elastic stretch direction of the first flexible patch is substantially parallel to the main elastic stretch direction of the second flexible patch, and the main elastic stretch direction of the first flexible patch is substantially parallel to a length direction of the first flexible piezoelectric layer.

In some embodiments, the first flexible patch and the second flexible patch each have a main elastic stretch direction, and the main elastic stretch direction of the first flexible patch is substantially parallel to the main elastic stretch direction of the second flexible patch, and the main elastic stretch direction of the first flexible patch is substantially perpendicular to a length direction of the first flexible piezoelectric layer.

In some embodiments, the swallowing sensing device further includes a second flexible piezoelectric element, which is enclosed in the flexible substrate layer. The second flexible piezoelectric element includes a second flexible piezoelectric layer, a third flexible electrode, and a fourth flexible electrode, and the third and fourth flexible electrodes are respectively located on opposite sides of the second flexible piezoelectric layer. The flexible substrate layer has a slit that penetrates the flexible substrate layer, and the slit is located between the first flexible piezoelectric element and the second flexible piezoelectric element. The length of the slit is greater than or equal to the length of at least one of the first and second flexible piezoelectric layers.

Another aspect of the present invention is to provide a swallowing sensing system, which includes a swallowing sensing device described in any of the above embodiments, an interface circuit, a wireless transmission unit, a signal receiving and converting unit, and a computer. The swallowing sensing device is configured to generate a piezoelectric signal. The interface circuit is electrically connected to the swallowing sensing device and configured to receive the piezoelectric signal and convert the piezoelectric signal into an electronic signal. The wireless transmission unit is electrically connected to the interface circuit and configured to receive the electronic signal and convert the electronic signal into a first wireless transmission signal and transmit the first wireless transmission signal. The signal receiving and converting unit is configured to receive the first wireless transmission signal and convert the first wireless transmission signal into a first digital signal. The computer is configured to receive the first digital signal and analyze the first digital signal to generate a swallowing signal.

In some embodiments, the swallowing sensing system further includes a breathing sensing module configured to generate a breathing electronic signal according to the breathing breath of a user and transmit the breathing electronic signal to the wireless transmission unit. The wireless transmission unit is further configured to convert the breathing electronic signal into a second wireless transmission signal and emit the second wireless transmission signal. The signal receiving and converting unit is further configured to receive the second wireless transmission signal and convert the second wireless transmission signal into a second digital signal. The computer is further configured to receive the second digital signal and analyze the second digital signal to generate a breathing signal.

In order to make the content of the present invention more detailed and complete, the following provides an illustrative description of the implementation aspects and specific embodiments of the present invention.

Spatially relative terms such as "below", "under", "above", "on", etc. are used in this article to facilitate the description of the relative relationship between one element or feature and another element or feature, as shown in the figure. The true meaning of these spatially relative terms includes other orientations. For example, when the figure is flipped 180 degrees up and down, the relationship between one element and another element may change from "below" and "under" to "above" and "on". In addition, the spatially relative descriptions used in this article should also be interpreted in the same way. In addition, the drawings of the present invention are only for illustration and to facilitate the understanding of the technical content of the specification, and are not accurately drawn according to the true scale.

It should be understood that although the terms "first", "second", etc. are used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another element. For example, a first element can be called a second element; similarly, a second element can be called a first element without departing from the scope of the embodiments. As used herein, the term "and/or" means any combination and all combinations of one or more related listed items.

It should be understood that, in this article, when an element is referred to as being "connected", "adjacent" or "coupled" to another element, it can be directly connected to another element or there can be an intervening element. On the contrary, when an element is referred to as being "directly connected" or "directly coupled" to another element, there is no intervening element.

The term "flexibility" herein refers to the property of being able to conform to the surface topography of an object and to fluctuate, which is, in a sense, relative to "rigidity". The term "patch" herein is not limited to fabrics or cloth. On the contrary, "patch" is a term commonly used by those of ordinary skill in the art to which the present invention belongs, and its materials include but are not limited to various polymer materials, non-woven fabrics, woven fabrics and/or cloths, and/or any combination of the above. In addition, "patch" in the sense includes an adhesive layer for attaching to another entity.

FIG1 is a cross-sectional view of a swallowing sensing device 10 according to some embodiments of the present invention. The swallowing sensing device 10 comprises a first flexible piezoelectric element 100 , a flexible substrate layer 130 , a first conductive line 141 , and a second conductive line 142 . The first flexible piezoelectric element 100 comprises a first flexible piezoelectric layer 101 , a first flexible electrode 110 , and a second flexible electrode 120 .

The first flexible piezoelectric layer 101 can generate a piezoelectric signal in response to changes in the body surface morphology of the subject. More specifically, the swallowing sensing device 10 can be attached to the throat of the subject (or "patient"), such as the skin surface of the hyoid bone 20 and/or the thyroid cartilage 30. The hyoid bone 20 and the thyroid cartilage 30 move during the swallowing process and cause changes in the body surface morphology, accompanied by changes in the length of the body surface, such as the length of the body surface lengthening or shortening. Due to the above-mentioned changes in body surface morphology, the first flexible piezoelectric layer 101 causes the flexible substrate layer 130 attached to the skin surface to deform along with the movement of the hyoid bone or thyroid cartilage, which in turn causes the first flexible piezoelectric layer 101 to strain and convert the strain into a piezoelectric signal, thereby achieving the technical effect of detecting and analyzing the swallowing process of the subject.

In some embodiments, the first flexible piezoelectric layer 101 includes polymer piezoelectric fibers. For example, the first flexible piezoelectric layer 101 may be a non-woven fabric or a fiber bundle formed of polymer piezoelectric fibers. In other embodiments, the first flexible piezoelectric layer 101 includes a polymer piezoelectric film, such as a film made of polyvinylidene difluoride (PVDF) or poly(vinylidene fluoride-trifluoroethylene) (P(VDF-TrFE)). In still other embodiments, the first flexible piezoelectric layer 101 includes polymer piezoelectric fibers and polymer piezoelectric films.

The first flexible electrode 110 and the second flexible electrode 120 are respectively located on opposite sides of the first flexible piezoelectric layer 101. In some embodiments, the first flexible electrode 110 is disposed on the first side 101a of the first flexible piezoelectric layer 101, and the second flexible electrode 120 is disposed on the second side 101b of the first flexible piezoelectric layer 101. When the first flexible piezoelectric layer 101 is deformed or strained, a piezoelectric signal is generated between the first side 101a and the second side 101b. The first and second flexible electrodes 110 and 120 are used to transmit the above-mentioned piezoelectric signal to the first wire 141 and the second wire 142, and then to an interface circuit (described in more detail below). In some embodiments, the first and second flexible electrodes 110 and 120 may be, for example, conductive polymers, cellulose nanofibers, flexible conductive films formed by combining conductive materials and fibers, or other suitable materials.

The flexible substrate layer 130 covers the first flexible piezoelectric layer 101, the first flexible electrode 110 and the second flexible electrode 120. In addition to protecting the first flexible piezoelectric layer 101, the first flexible electrode 110 and the second flexible electrode 120, the flexible substrate layer 130 must also be able to transmit the changes in the body surface morphology caused by the hyoid bone 20 and/or the thyroid cartilage 30 to the first flexible piezoelectric layer 101. In some embodiments, the flexible substrate layer includes a flexible polymer material. For example, the flexible substrate layer can be made of polydimethylsiloxane (PDMS), silicone, polyester polymer, polyurethane, or other biocompatible and non-toxic flexible polymer materials. According to some embodiments of the present invention, the thickness of the flexible substrate layer 130 is relatively small, which is beneficial for the first flexible piezoelectric layer 101 to obtain a surface topography change of the hyoid bone 20 and/or the thyroid cartilage 30 that is closer to the real one, and avoids the phenomenon that the surface topography change of the hyoid bone and/or the thyroid cartilage is distorted after being transmitted through the flexible substrate layer due to deformation of the flexible substrate layer 130 in the thickness direction. In some embodiments, the thickness of the flexible substrate layer 130 is less than about 1 mm, for example, 0.2 mm, 0.4 mm, 0.5 mm, or 0.8 mm, etc.

The first wire 141 and the second wire 142 each extend from the inside of the flexible substrate layer 130 to the outside of the flexible substrate layer 130. One end of the first wire 141 is connected to the first flexible electrode 110, and the other end of the first wire 141 is located outside the flexible substrate layer 130. Similarly, one end of the second wire 142 is connected to the second flexible electrode 120, and the other end is located outside the flexible substrate layer 130.

The swallowing sensing device according to the embodiment of the present invention provides excellent wearing comfort for the subject because of the use of a flexible piezoelectric layer, a flexible electrode and a flexible substrate layer, and greatly reduces the discomfort of the subject. Therefore, the swallowing sensing device according to the embodiment of the present invention is more suitable for monitoring the swallowing process of the subject for a long time.

In some embodiments, the swallowing sensing device 10 further includes an adhesive layer 150 disposed on the lower surface 130b of the flexible substrate layer 130. The adhesive layer 150 is used to adhere the swallowing sensing device 10 to the skin 40 of the subject. According to some embodiments of the present invention, the thickness of the adhesive layer 150 is relatively small, which is beneficial for the first flexible piezoelectric layer 101 to obtain a surface morphology change closer to the real hyoid bone 20 and/or thyroid cartilage 30. In some embodiments, the thickness of the adhesive layer 150 is less than about 0.3 mm, for example, 0.05 mm, 0.1 mm, 0.15 mm, or 0.2 mm.

FIG2 is a schematic cross-sectional view of a swallowing sensing device 10a according to certain embodiments of the present invention, and FIG3 is a schematic top view of the swallowing sensing device 10a. The structure of the swallowing sensing device 10a is similar to the swallowing sensing device 10 shown in FIG1. In short, the swallowing sensing device 10a includes a first flexible piezoelectric layer 101, a first flexible electrode 110, a second flexible electrode 120, a flexible substrate layer 130, a first conductive wire 141, and a second conductive wire 142. In addition, the swallowing sensing device 10a further includes a first flexible patch 161 and a second flexible patch 162. A portion of the first flexible patch 161 is disposed or adhered to the upper surface 130a of the flexible substrate layer 130, and another portion of the first flexible patch 161 extends beyond the first side 131 of the flexible substrate layer 130. Similarly, a portion of the second flexible patch 162 is disposed or adhered to the upper surface 130a, and another portion of the second flexible patch 162 extends beyond the second side 132 of the flexible substrate layer 130, and the first side 131 is opposite to the second side 132. The portions of the first flexible patch 161 and the second flexible patch 162 extending beyond the flexible substrate layer 130 are used to adhere the swallowing sensing device 10a to the skin 40 of the subject.

In some embodiments, the first flexible patch 161 and the second flexible patch 162 are separated by a distance W. In the direction perpendicular to the upper surface 130a of the flexible substrate layer, the first flexible patch 161 and the second flexible patch 162 do not overlap with the first flexible piezoelectric layer 101. This design can reduce the interference of the first flexible piezoelectric layer 101 caused by the changes in the body surface morphology below the position where the first and second flexible patches 161 and 162 are attached to the skin.

Referring to the top view of FIG. 3 , in some embodiments, there is a horizontal distance D1 between the first flexible patch 161 and the first flexible piezoelectric layer 101, and the horizontal distance D1 is about 5 mm to about 10 mm, such as about 6 mm, about 7 mm, about 8 mm, or about 9 mm. Similarly, there is a horizontal distance D2 between the second flexible patch 162 and the first flexible piezoelectric layer 101, and the horizontal distance D2 is also about 5 mm to about 10 mm, such as about 6 mm, about 7 mm, about 8 mm, or about 9 mm.

In some embodiments, the first flexible patch 161 and the second flexible patch 162 each have a main elastic stretch direction E1, E2. The main elastic stretch direction E1 of the first flexible patch 161 is substantially parallel to the main elastic stretch direction E2 of the second flexible patch 162. The main elastic stretch directions E1, E2 of the first flexible patch 161 and the second flexible patch 162 are substantially parallel to the length direction F of the first flexible piezoelectric layer 101. The elastic stretch directions E1 and E2 are generated by the hyoid bone or thyroid cartilage under the attached skin 40 passing through the swallowing sensing device 10a, and then the swallowing sensing device 10a is stretched in the opposite direction of the outward direction, and shrinks in the opposite direction to return to the original size after passing. When the swallowing sensing device 10a is used, the main elastic stretching directions E1 and E2 of the first flexible patch 161 and the second flexible patch 162 are substantially perpendicular to the moving direction G of the hyoid bone and/or thyroid cartilage of the subject. The above-mentioned "main elastic stretching direction" means that the elastic stretching degree in this direction is much greater than that in other directions.

FIG4 shows a schematic top view of a swallowing sensing device 10b according to certain embodiments of the present invention. The structure of the swallowing sensing device 10b is similar to the swallowing sensing device 10a shown in FIG3 . For the purpose of brevity, only the differences between the two are described below. The swallowing sensing device 10b further includes a second flexible piezoelectric element 200 . The structure of the second flexible piezoelectric element 200 may be the same as or similar to the first flexible piezoelectric element 100 . For example, the second flexible piezoelectric element includes a second flexible piezoelectric layer 202 , a third flexible electrode, and a fourth flexible electrode (not shown in FIG4 ), and the third and fourth flexible electrodes are respectively located on opposite sides of the second flexible piezoelectric layer. The second flexible piezoelectric element 200 is arranged substantially parallel to the first flexible piezoelectric element 100 . The second flexible piezoelectric element 200 is also encapsulated in the flexible substrate layer 130. In addition, the swallowing sensing device 10b further includes a third wire and a fourth wire (not shown in FIG. 4 ), which are respectively connected to the third and fourth flexible electrodes.

The flexible substrate layer 130 has a slit 134 penetrating the flexible substrate layer 130, and the slit 134 is located between the first flexible piezoelectric element 100 and the second flexible piezoelectric element 200, and the length of the slit 134 is greater than or equal to the length of the first and/or second flexible piezoelectric layers 101, 202. The slit can prevent the first and second flexible piezoelectric elements 100, 200 from interfering with each other due to changes in the body surface morphology below. This implementation method can monitor the movement of the hyoid bone or thyroid cartilage under the attached skin during swallowing, and can use the distance L between the first and second flexible piezoelectric layers 101, 202 to calculate the movement information of the hyoid bone or thyroid cartilage during lifting and recovery, including physiological information such as speed, movement time, and distance.

FIG5 shows a schematic top view of a swallowing sensing device 10c according to certain embodiments of the present invention. The structure of the swallowing sensing device 10c is similar to that of the swallowing sensing device 10a shown in FIG3 , except that the first flexible piezoelectric element 100 is configured. Specifically, the length direction F of the first flexible piezoelectric element 100 is substantially perpendicular to the main elastic stretching directions E1 and E2 of the first flexible patch 161 and the second flexible patch 162. In addition, when the swallowing sensing device 10c is used, the length direction F of the first flexible piezoelectric element 100 is substantially parallel to the movement direction G of the hyoid bone and/or thyroid cartilage of the subject.

FIG6 is a schematic cross-sectional view of a swallowing sensing device 10d according to certain embodiments of the present invention. The structure of the swallowing sensing device 10d is similar to that of the swallowing sensing device 10a shown in FIG2 , except that the swallowing sensing device 10d only includes a flexible patch 160. The flexible patch 160 covers the upper surface 130a of the flexible substrate layer 130, and the flexible patch 160 extends beyond two opposite sides of the flexible substrate layer 130, for example, beyond the first side edge 131 and the second side edge 132. The portion of the flexible patch 160 extending beyond the flexible substrate layer 130 is used to adhere the swallowing sensing device 10d to the skin 40 of the subject. In some embodiments, the flexible patch 160 has substantially isodirectional elasticity.

Another aspect of the present invention is to provide a swallowing sensing system. FIG7 shows a functional block diagram of a swallowing sensing system 300 according to some embodiments of the present invention. The swallowing sensing system 300 includes at least one swallowing sensing device 302, an interface circuit 310, a wireless transmission unit 320, a signal receiving and converting unit 330, and a computer 340.

The swallowing sensing device 302 may be, for example, the swallowing sensing device 10, 10a-10d described in any of the above embodiments or examples. There may be multiple sets of swallowing sensing devices, such as 1, 2, 3, or 4 sets or more. The swallowing sensing device 302 is configured to generate a piezoelectric signal. For example, the swallowing sensing device 302 may be attached to the skin surface of the hyoid bone and/or thyroid cartilage of the subject. When the subject swallows, the hyoid bone and/or thyroid cartilage causes the body surface morphology to change, and the swallowing sensing device 302 generates a piezoelectric signal.

The interface circuit 310 is electrically connected to the swallowing sensing device 302 and is configured to receive the piezoelectric signal transmitted from the swallowing sensing device 302. For example, the interface circuit 310 is connected to the first lead 141 and the second lead 142 of the swallowing sensing device described above. The interface circuit 310 further converts the piezoelectric signal into an electronic signal. In some embodiments, the interface circuit 310 includes a noise filter circuit, a signal amplifier, and an analog-to-digital conversion circuit.

The wireless transmission unit 320 is electrically connected to the interface circuit 310 and is configured to receive the electronic signal transmitted from the interface circuit 310. The wireless transmission unit 320 further converts the received electronic signal into a first wireless transmission signal and transmits the first wireless transmission signal. In some embodiments, the wireless transmission unit 320 includes a Bluetooth output unit, a wireless broadband output unit, or other suitable wireless transmission modules or units.

The signal receiving and converting unit 330 is configured to receive the first wireless transmission signal transmitted from the wireless transmission unit 320, and further convert the first wireless transmission signal into a first digital signal. In some embodiments, the signal receiving and converting unit 330 includes a wireless receiving unit, such as a Bluetooth receiving unit, a wireless broadband receiving unit, or other appropriate receiving units or modules corresponding to the data format of the wireless transmission unit 320.

The computer 340 is configured to receive a first digital signal transmitted from the signal receiving and converting unit 330, the first digital signal including at least one set of signals of a swallowing sensing device, and further analyze the first digital signal to generate a swallowing signal. In some embodiments, the computer 340 includes a processor and a computer-readable storage medium. The computer-readable storage medium stores a swallowing reflex analysis program and a user interface software. The processor in the computer 340 executes the swallowing reflex analysis program to analyze and calculate the first digital signal, and thus generates a swallowing signal.

In some embodiments, the swallowing sensing system 300 further includes a display 360, and the swallowing signal can be transmitted to the display 360 using the user interface software, allowing medical professionals to analyze or monitor the swallowing signal of the subject.

In some embodiments, the swallowing sensing system 300 further includes a breathing sensing module 350. The breathing sensing module 350 is configured to generate a breathing electronic signal according to the breathing breath of a subject, and transmit the breathing electronic signal to the wireless transmission unit 320. In this embodiment, the wireless transmission unit 320 is further configured to convert the breathing electronic signal into a second wireless transmission signal and transmit the second wireless transmission signal. The signal receiving and converting unit 330 is further configured to receive the second wireless transmission signal and convert the second wireless transmission signal into a second digital signal. The computer 340 is further configured to receive the second digital signal and analyze the second digital signal to generate a breathing signal.

FIG8 to FIG10 are schematic diagrams showing the use of the swallowing sensing device 10a described above with respect to FIG3 in certain embodiments of the present invention. As shown in FIG8 , the swallowing sensing device 10a is attached to the moving path of the thyroid cartilage 30 during the swallowing process of the subject. Specifically, the swallowing sensing device 10a is attached to a position between 0 cm and about 2.5 cm above the upper edge of the thyroid cartilage 30, taking the upper edge position of the thyroid cartilage 30 before the start of the swallowing action as the reference position. The length direction of the flexible piezoelectric layer in the swallowing sensing device 10a is substantially perpendicular to the moving direction G1 of the thyroid cartilage.

As shown in FIG9 , the swallowing sensing device 10a is attached to the moving path of the hyoid bone 20 during the swallowing process of the subject. The upper edge position of the hyoid bone 20 before the swallowing action starts is used as the reference position, and the swallowing sensing device 10a is attached to a position between 0 cm and about 2 cm above the upper edge of the hyoid bone 20. The length direction of the flexible piezoelectric layer in the swallowing sensing device 10a is substantially perpendicular to the hyoid bone movement direction G2.

As shown in FIG10 , two sets of swallowing sensing devices 10a are used, which are respectively attached to the moving paths of the hyoid bone 20 and the thyroid cartilage 30 during the swallowing process of the subject. One set of swallowing sensing devices 10a is attached to a position between 0 cm and about 2 cm above the upper edge of the hyoid bone 20, and the other set of swallowing sensing devices 10a is attached to a position between 0 cm and about 2.5 cm above the upper edge of the thyroid cartilage 30. The length direction of the flexible piezoelectric layer in the swallowing sensing device 10a is substantially perpendicular to the hyoid bone moving direction G2 and the thyroid cartilage moving direction G1.

FIG. 11 to FIG. 13 are schematic diagrams showing certain embodiments of the present invention using the swallowing sensing device 10b described above with respect to FIG. 4. As shown in FIG. 11, the swallowing sensing device 10b is attached to a position between 0 cm and about 2.5 cm above the upper edge of the subject's thyroid cartilage 30. The slit 134 (marked in FIG. 4) between the first and second flexible piezoelectric elements 100, 200 (marked in FIG. 4) in the swallowing sensing device 10b can reduce mutual interference between the first and second flexible piezoelectric elements 100, 200, thereby avoiding distortion of the measured signal. The length direction of the flexible piezoelectric layer in the swallowing sensing device 10b is substantially perpendicular to the movement direction of the thyroid cartilage.

As shown in Fig. 12, the swallowing sensing device 10b is attached to a position between 0 cm and about 2 cm above the upper edge of the hyoid bone 20 of the subject. The length direction of the flexible piezoelectric layer in the swallowing sensing device 10b is substantially perpendicular to the movement direction of the hyoid bone.

As shown in FIG13 , two sets of swallowing sensing devices 10b are used, one set is attached to a position between 0 cm and about 2 cm above the upper edge of the hyoid bone 20 of the subject, and the other set is attached to a position between 0 cm and about 2.5 cm above the upper edge of the thyroid cartilage 30. The length direction of the flexible piezoelectric layer in the swallowing sensing device 10b is substantially perpendicular to the movement direction of the hyoid bone and the movement direction of the thyroid cartilage.

FIG. 14 to FIG. 16 are schematic diagrams showing the use of the swallowing sensing device 10c described above with respect to FIG. 5 in certain embodiments of the present invention. As shown in FIG. 14 , the swallowing sensing device 10c is attached to the moving path of the thyroid cartilage 30 during the swallowing process of the subject. With the upper edge position of the thyroid cartilage 30 before the start of the swallowing action as the reference position, the lower end of the swallowing sensing device 10c is located at the upper edge of the thyroid cartilage 30, and the swallowing sensing device 10c is attached along the direction of the upward movement of the thyroid cartilage 30, with a length of about 1.5 cm to about 2.0 cm. The length direction of the flexible piezoelectric layer in the swallowing sensing device 10c is substantially parallel to the moving direction of the thyroid cartilage.

As shown in FIG15 , the swallowing sensing device 10c is attached to the moving path of the hyoid bone 20 during the swallowing process of the subject. The upper edge position of the hyoid bone 20 before the swallowing action begins is used as the reference position, and the lower end of the swallowing sensing device 10c is located at the upper edge of the hyoid bone 20. The swallowing sensing device 10c is attached along the upward movement direction of the thyroid cartilage 30, and the length is about 1 cm to about 2.0 cm. The length direction of the flexible piezoelectric layer in the swallowing sensing device 10c is roughly parallel to the movement direction of the hyoid bone.

As shown in FIG16 , two sets of swallowing sensing devices 10c are used and attached to the moving paths of the hyoid bone 20 and the thyroid cartilage 30 during the swallowing process of the subject. The attachment positions of the swallowing sensing devices 10c are as described above with respect to FIG14 and FIG15 .

FIG. 17 is a schematic diagram of a combination of a breathing sensing module 350 (indicated in FIG. 7 ) and two swallowing sensing devices shown in FIG. 10 according to certain embodiments of the present invention. The breathing sensing module 350 may include a breathing tube 352, which may be connected to the nasal cavity or oral cavity of the subject to detect the breathing of the subject. The breathing sensing module 350 generates a breathing electronic signal according to the breathing of the subject. At the same time, two swallowing sensing devices are used to be attached to the movement paths of the hyoid bone 20 and the thyroid cartilage 30 during the swallowing process of the subject.

FIG18 is a diagram showing the measurement results of using two swallowing sensing devices 10c as shown in FIG16. As shown in FIG18, when the subject is swallowing, the two swallowing sensing devices 10c can respectively measure the swallowing signals of the hyoid bone 20 and the thyroid cartilage 30. Medical professionals can use the swallowing signals to determine whether the subject has swallowing difficulties or incomplete swallowing movements.

FIG19 is a diagram showing the measurement results of the combined breathing sensing module and two swallowing sensing devices shown in FIG17. As shown in FIG19, when the subject is swallowing, the two swallowing sensing devices can measure the swallowing signals of the hyoid bone and the thyroid cartilage respectively. More importantly, when the subject is swallowing, it can be detected whether the breathing stops briefly during swallowing. In FIG19, it can be observed that the swallowing signal occurs during the time period of the short breathing stop. Therefore, by combining the breathing signal and the swallowing signal, medical professionals can have more complete information to determine whether the subject has swallowing difficulties or incomplete swallowing.

The above discloses multiple embodiments (or examples) and related technical effects of the present invention. Different embodiments or examples may have different or the same technical effects. Therefore, any embodiment (or example) or patent application scope of the present invention does not need to achieve all the purposes, advantages, or features disclosed by the present invention. Furthermore, the content disclosed in the above text is only part of the many embodiments of the present invention, and it is not used to limit the present invention. All simple equivalent changes and modifications made according to the content of the patent application scope of this new model are within the scope covered by the patent of this new model. In addition, the abstract part and the new model name are only used to assist the retrieval of patent documents, and are not used to limit the scope of rights of the present model.

10: Swallowing sensor device

10a: Swallowing sensing device

10b: Swallowing sensing device

10c: Swallowing sensor device

10d: Swallowing sensor device

20: Hyoid bone

30: Thyroid cartilage

40: Skin

100: first flexible piezoelectric element

101: first flexible piezoelectric layer

101a: First side

101b: Second side

110: first flexible electrode

120: Second flexible electrode

130: Flexible substrate layer

130a: upper surface

130b: Lower surface

131: First side

132: Second side

134: Narrow seam

141: First Conductor

142: Second wire

150: Adhesive layer

161: First flexible patch

162: Second flexible patch

200: second flexible piezoelectric element

202: Second flexible piezoelectric layer

300: Swallowing sensor system

302: Swallowing sensor device

310: Interface circuit

320: Wireless transmission unit

330: Signal receiving and conversion unit

340: Computer

350: Breathing sensor module

360:Display

D1: Horizontal spacing

D2: Horizontal spacing

E1: Main elastic stretching direction

E2: Main elastic stretching direction

F: Length direction

G: Direction of movement of the hyoid bone and/or thyroid cartilage

G1: Thyroid cartilage movement direction

G2: Direction of hyoid bone movement

L: Distance

W: Spacing

FIG. 1 is a schematic cross-sectional view of a swallowing sensing device according to certain embodiments of the present invention. FIG. 2 is a schematic cross-sectional view of a swallowing sensing device according to certain embodiments of the present invention. FIG. 3 is a schematic top view of a swallowing sensing device according to certain embodiments of the present invention. FIG. 4 is a schematic top view of a swallowing sensing device according to certain embodiments of the present invention. FIG. 5 is a schematic top view of a swallowing sensing device according to certain embodiments of the present invention. FIG. 6 is a schematic cross-sectional view of a swallowing sensing device according to certain embodiments of the present invention. FIG. 7 is a functional block diagram of a swallowing sensing system according to certain embodiments of the present invention. FIG. 8 to FIG. 10 are schematic diagrams of using a swallowing sensing device according to certain embodiments of the present invention. Figures 11 to 13 are schematic diagrams of using a swallowing sensing device in certain embodiments of the present invention. Figures 14 to 16 are schematic diagrams of using a swallowing sensing device in certain embodiments of the present invention. Figure 17 is a schematic diagram of using a breathing sensing module in combination with a swallowing sensing device in certain embodiments of the present invention. Figure 18 is a diagram of measurement results using two sets of swallowing sensing devices as shown in Figure 16. Figure 19 is a diagram of measurement results using a breathing sensing module combined with two sets of swallowing sensing devices as shown in Figure 17.

10: Swallowing sensor device

20: Hyoid bone

30:thyroid cartilage

40: Skin

100: First flexible piezoelectric element

101: First flexible piezoelectric layer

101a: First side

101b: Second side

110: First flexible electrode

120: Second flexible electrode

130: Flexible substrate layer

130a: Upper surface

130b: Lower surface

141: First conductor

142: Second conductor

150: Adhesive layer

Claims (7)

A swallowing sensing device is used to be attached to the skin surface of the moving area of the hyoid bone and/or thyroid cartilage of a subject, and the swallowing sensing device comprises: a first flexible piezoelectric element, comprising: a first flexible piezoelectric layer; and a first flexible electrode and a second flexible electrode, respectively located on two opposite sides of the first flexible piezoelectric layer; a flexible substrate layer, covering the first flexible piezoelectric layer, the first flexible electrode and the second flexible electrode; a first wire extending from the inside of the flexible substrate layer to the outside of the flexible substrate layer, one end of the first wire connected to the first flexible electrode; a second wire , extending from the inside of the flexible substrate layer to the outside of the flexible substrate layer, one end of the second wire is connected to the second flexible electrode; a first flexible patch, arranged on an upper surface of the flexible substrate layer and extending beyond a first side of the flexible substrate layer; and a second flexible patch, arranged on the upper surface and spaced apart from the first flexible patch by a distance, the second flexible patch extending beyond a second side of the flexible substrate layer, the first side being opposite to the second side; wherein in a direction perpendicular to the upper surface, the first flexible patch and the second flexible patch do not overlap with the first flexible piezoelectric layer. The swallowing sensing device as described in claim 1, wherein a horizontal distance between the first flexible patch and the first flexible piezoelectric layer is about 5 mm to about 10 mm, and a horizontal distance between the second flexible patch and the first flexible piezoelectric layer is about 5 mm to about 10 mm. The swallowing sensing device as described in claim 1, wherein the first flexible patch and the second flexible patch each have a main elastic stretch direction, and the main elastic stretch direction of the first flexible patch is substantially parallel to the main elastic stretch direction of the second flexible patch, and the main elastic stretch direction of the first flexible patch is substantially parallel to a length direction of the first flexible piezoelectric layer. The swallowing sensing device as described in claim 1, wherein the first flexible patch and the second flexible patch each have a main elastic stretch direction, and the main elastic stretch direction of the first flexible patch is substantially parallel to the main elastic stretch direction of the second flexible patch, and the main elastic stretch direction of the first flexible patch is substantially perpendicular to a length direction of the first flexible piezoelectric layer. The swallowing sensing device as described in claim 1 further includes a second flexible piezoelectric element, which is encapsulated in the flexible substrate layer; wherein the second flexible piezoelectric element includes a second flexible piezoelectric layer, a third flexible electrode and a fourth flexible electrode, and the third and fourth flexible electrodes are respectively located on opposite sides of the second flexible piezoelectric layer; and the flexible substrate layer has a slit penetrating the flexible substrate layer, and the slit is located between the first flexible piezoelectric element and the second flexible piezoelectric element, and the length of the slit is greater than or equal to the length of at least one of the first and second flexible piezoelectric layers. A swallowing sensing system comprises: at least one swallowing sensing device as described in claim 1, configured to generate a piezoelectric signal; an interface circuit electrically connected to the swallowing sensing device and configured to receive the piezoelectric signal and convert the piezoelectric signal into an electronic signal; a wireless transmission unit electrically connected to the interface circuit and configured to receive the electronic signal and convert the electronic signal into a first wireless transmission signal and transmit the first wireless transmission signal; a signal receiving and conversion unit configured to receive the first wireless transmission signal and convert the first wireless transmission signal into a first digital signal; and a computer configured to receive the first digital signal and analyze the first digital signal to generate a swallowing signal. The swallowing sensing system as described in claim 6 further comprises a breathing sensing module configured to generate a breathing electronic signal according to the breathing breath of a user and transmit the breathing electronic signal to the wireless transmission unit; wherein the wireless transmission unit is further configured to convert the breathing electronic signal into a second wireless transmission signal and transmit the second wireless transmission signal; the signal receiving and converting unit is further configured to receive the second wireless transmission signal and convert the second wireless transmission signal into a second digital signal; and the computer is further configured to receive the second digital signal and analyze the second digital signal to generate a breathing signal.