WO2019026089A1

WO2019026089A1 - Breath hold support and position monitoring device

Info

Publication number: WO2019026089A1
Application number: PCT/IN2018/050505
Authority: WO
Inventors: Puhazhendi KALIYAPPAN
Original assignee: Perfint Healthcare Pvt Ltd
Priority date: 2017-08-02
Filing date: 2018-08-02
Publication date: 2019-02-07

Abstract

The present disclosure relates to a device for physiological monitoring. More particularly, relates to a device for breath hold support, position detection and monitoring of a patient during examination with an imaging device or an interventional procedure. The device comprising of a belt, a first sensor, a second sensor and a processing module. Wherein at least one belt is wrapped around a patient being examined such that the belt provides a tangible locus to the human body for reaching a predefined threshold value and to stop further exhalation. Also, the device provides a direct feedback to the human body about size of his/her abdomen and/or chest by an indicator unit which emits light and sound. Whereas, an operator of the imaging device or an interventional procedure can receive the feedback on an external device during the interventional process. The breath hold support and position monitoring device is simple, easy to operate and affordable.

Description

TITLE: BREATH HOLD SUPPORT AND POSITION MONITORING DEVICE

TECHNICAL FIELD

The present disclosure relates to device for physiological monitoring. More particularly, relates to a device for detection and monitoring of breath hold level and position of the human body. BACKGROUND

X-ray images or scans are conventionally acquired by various medical imaging techniques which projects electromagnetic radiation or X-rays that differentially penetrates structures within a patient's body and creates images of these structures on photographic film or a fluorescent screen. These images are useful in detecting abnormalities such as broken bones, tumours, dental decay, and the presence of foreign bodies within the patient' s body. Medical imaging technique includes conventional X-ray devices, Positron emission tomography-computed tomography (better known as PET-CT or PET/CT), magnetic resonance imaging (MRI) mammography etc.,

It is sometimes desirable to take an image of the chest or abdomen when the lungs are fully inflated, in order to study the lungs. At other times, it is desirable to take the image when the lungs are fully deflated, in order to study the surrounding area of the lungs. Thus, the patient must be instructed to be at any respiratory position during. The operator of an imaging device usually instructs the patients to inhale or to exhale, and to maintain that condition for an instant, during which the image is taken. In case, if patient breathes during the course of taking image, a blur image may be produced due to movement of patient's diaphragm and chest. If the image is blurred, the imaging will have to be repeated. Moreover, when the image is used for any interventional procedure, the patient has to reproduce a breath hold level same as preceding imaging session. Further, patient should be positioned in appropriately in order to prevent blurred images. It is difficult for any patient to remember the breath hold level and position of the preceding imaging session.

Conventionally, various devices which can be wrapped around the patient for the purpose of breath hold monitoring during imaging. These conventional devices have not been satisfactory because the patient has to adjust the breath level based on an external feedback provided to the operator by the devices. These conventional devices don't have any tangible locus for the patent to hold his/her breath or any indication for the patent to stop further exhalation. Accordingly, a need exists for a device to seek to mitigate one or more above shortcomings. Consequently, those skilled in the art will appreciate the present disclosure that provides many advantages and overcomes all the above and other limitations.

SUMMARY

The one or more shortcomings of the prior art are overcome by a breath hold support and position monitoring device as claimed and additional advantages are provided through the provisions as claimed in the present disclosure. Other embodiments and aspects of the disclosure are described in detail herein.

The present disclosure provides the breath hold support and position monitoring device, comprising at least one belt, a first sensor, a second sensor and a processing module.

The at least one belt having lock elements at two ends is wearable around a human body. Further, the first sensor and the second sensor are attached to at least one belt, wherein the first and the second sensor configured to respectively detect breath hold level and position of the human body. Further, the first and the second sensor respectively generate a first analog sensor signal and a second analog sensor signal indicative of the breath hold level and position of the human body.

The processing module of the device is in communication with the first sensor and the second sensor, and configured to receive the first and the second analog sensor signal and generate a first feedback signal and a second feedback signal of breath hold level and the position of the human body respectively.

In an embodiment, the processing module further comprises an analog-to-digital converter and a microcontroller. The analog-to-digital converter is configured to receive and convert the first and second analog sensor signals to a corresponding first digital signal and a second digital signal. In an embodiment, the microcontroller is configured to process the first and second digital signal and to respectively generate the first and second feedback signals based on comparison of the breath hold level and position value received in the first and second digital signals with a predefined threshold values of breath hold level and position of the human body. In an embodiment, the processing module further includes an indication unit configured to receive the first and second feedback signals from the microcontroller and indicate the breath hold level and position of the human body. The indication unit comprises at least two light sources and one audio unit respectively to emit light and sound based on the first and second feedback signals.

In an embodiment, the the microcontroller determines the predefined threshold value of the breath hold level and the position of the human body based on breath hold level and position of the human body recorded for a predetermined time.

In another embodiment, the microcontroller is coupled to an external device configured to receive the first and second feedback signals and to display the breath hold level and position of the human body with respect to the pre-defined threshold breath hold and position of the human body. In yet another embodiment, the belt of the device comprises a pouch to receive the first and second sensor respectively.

In an embodiment, the microcontroller identifies the location of the first and second sensors and displays a graphical representation indicating the location on the external device to facilitate better visualization and decision making. It is to be understood that the aspects and embodiments of the disclosure described above may be used in any combination with each other. Several of the aspects and embodiments may be combined together to form a further embodiment of the disclosure.

The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The novel features and characteristic of the disclosure are set forth in the appended claims. The disclosure itself, however, as well as a preferred mode of use, further objectives and advantages thereof, will best be understood by reference to the following detailed description of an illustrative embodiment when read in conjunction with the accompanying figures. One or more embodiments are now described, by way of example only, with reference to the accompanying figures wherein like reference numerals represent like elements and in which:

Figure 1 illustrates a perspective view of a breath hold support and position monitoring device in accordance with some embodiments of the present disclosure; Figure 2 illustrates a block diagram of the device of Figure.1, in accordance with some embodiments of the present disclosure; and

Figure 3 illustrates a perspective view of a breath hold support and position monitoring device wrapped to a human body, in accordance with some embodiments of the present disclosure. The figures depict embodiments of the disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the apparatus and methods illustrated herein may be employed without departing from the principles of the disclosure described herein DETAILED DESCRIPTION

In the present document, the word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment or implementation of the present subject matter described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

While the disclosure is susceptible to various modifications and alternative forms, specific embodiment thereof has been shown by way of example in the drawings and will be described in detail below. It should be understood, however that it is not intended to limit the disclosure to the forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternative falling within the scope of the disclosure.

The terms "comprises", "comprising", or any other variations thereof, are intended to cover a nonexclusive inclusion, such that an apparatus or method that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such setup or device or process. In other words, one or more elements in a system or apparatus proceeded by "comprises... a" does not, without more constraints, preclude the existence of other elements or additional elements in the system or apparatus.

Embodiments of the present disclosure relates to physiological monitoring and indicator device. Referring to Figure 1 to Figure 3, a breath hold support and position monitoring device 100 during imaging (hereby referred to as "the device 100") comprises at least one belt 10, a first sensor 20, a second sensor 25, and a processing module 30.

The device 100 of the present disclosure as shown in Figure 1, comprises of the at least one belt (hereinafter referred to as belt) 10. The belt 10 is a band or strap wearable by a human body 200, made of a flexible X-ray friendly material, provided with lock elements 11 to fasten the two ends together and means for adjusting the size to meet the requirements of the human body 200. In an embodiment, the belt 10 is wrapped around the human body 200 during imaging his/her bodily organs like abdomen and/or chest. In an embodiment, the lock elements may be a buckle, Velcro tape fastener, adhesive or any other suitable means of fastening. The device 100, further comprises a first sensor 20 and a second sensor 25 are attached to the belt 10. The first sensor 20 is configured to detect the breath hold level and the second sensor 25 is configured to determine the position of the human body 200. Further, the belt 10 comprises of a pouch 40 to receive the first sensor 20 and the second sensor 25. The pouch 40 has an inner compartment. The pouch 40 is mounted to the belt 10 to juxtapose the anterior of the human body's 200 abdomen and chest. In an embodiment, the belt 10 and pouch 40 are made of X-ray friendly material.

Further, the first sensor 20 is employed wired or wirelessly for the purpose of generating a first analog sensor signal 21 indicative of the breath hold level of the human body 200. In an embodiment, the first analog signal 21 corresponds to the size of the abdominal and/or chest of the human body 200 to be imaged. Similarly, the second sensor 25 is configured to generate a second analog sensor signal 26 indicative of the position of the human body 200 during imaging. In an embodiment, the first sensor 20 may be a pressure sensor capable of detecting the breath hold level of the human body and the second sensor 25 may be a sensor selected from a group consisting of accelerator, magneto and gyroscopic sensor and the like to detect the position or orientation of the human body 200 during the breath hold level state.

As shown in Figure 2, the processing module 30 is in communication with the first sensor 20 and the second sensor 25 to receive the first and second analog sensor signals 21, 26 and further configured to generate a first feedback signal 23 and a second feedback signal 28 of the breath hold and the position of the human body 200. The processing module 30 comprises a printed circuit board (PCB) 50 comprising of an analog-to-digital converter (ADC) 51, a microcontroller 52 and an indication unit 53. The ADC 51 receives and converts the first analog sensor signal 21 to a corresponding first digital signal 22. Further, the ADC 51 receives and converts the second analog sensor signal 26 to a second digital signal 27. The microcontroller 52 comprises a digital processor and memory. The microcontroller 52 is configured to receive and process the first and the second digital signals 22, 27 and store, in the memory, the data related to the size of abdomen and/or chest of the human body 200 to be examined and position during the breath hold level of the human body 200. The microcontroller 52 is configured to process the first and the second digital signals

22, 27 and generate a first feedback signal 23 and a second feedback signal 28 respectively. Further, the first and the second feedback signals 23, 28 are generated based on comparison of the breath hold level and position value received in the first and second digital signals 22, 27 with a predefined threshold values of breath hold level and position of the human body 200.

In an embodiment, the first and the second feedback signal 23, 28 is provided to the indication unit 53. The indication unit 53 comprises at least two light sources and an audio unit that emits lights and sound alarm as a feedback to the human body 200. The indication unit 53 also emits light and sound based on the first and second feedback signals 23, 28 i.e., after receiving processed and compared breath hold level and position value received by first and second feedback signals 23, 28 with a predefined threshold value of the breath hold level and position of the human body 200. The predefined threshold values of the breath hold level and position of the human body 200 are processed and compared by the microcontroller 52 and the first and the second feedback signals

23, 28 are provided to the indication unit. The predefined threshold value of the breath hold level and position is determined by the microcontroller 52 during an initial breath hold level and position observed for a predetermined time based on size of the abdominal and/or chest of the human body 200. In an embodiment, the predefined threshold value is recorded based on maximum/ minimum size of the abdominal and/ or chest of the particular human body during the inhaling and exhaling. In an embodiment, the threshold value is recorded, wherein human body 200 during imaging is made to lay down on a bed and the belt 10 is wrapped around the human body 200. Further, the human body 200 is instructed to inhale and exhale. During inhalation, the human body 200 is instructed to hold the breath for predetermined time, wherein the threshold value of the breath hold level and position of the human body is automatically recorded by the microcontroller 52. In an embodiment, the process is carried out to automatically record the threshold value of the breath hold level and position of the human body 200 during the exhalation. In an embodiment, the predetermined time to record the predefined threshold value for breath level and position ranges from 2 seconds to 5 seconds. Further, at the time of recording the threshold value, the belt 10 can be tightened to ensure that, the recorded threshold value corresponds to the tightness of the belt 10, thereby providing a tactile feedback during when the human body 200 is instructed to hold the breath.

The indication unit 53 comprises a plurality of light sources, a first light source to emit light when the human body 200 have reached the predefined threshold value of the breath hold level. A second light source emits light when the human body 200 have not reached the predefined threshold value of the said breath hold level. Additionally, the indication unit 53 may comprise a third light source to emit a light indicating position and/or movement of the human body 200. The indication unit 53 emits sound to ensure an audio feed back to the human body 200. The indication unit 53 facilitates, an operator to instruct the human body 200 in order to match a previously recorded predefined value of the breath hold level and position of the human body 200. In an embodiment, the indication unit 53 emits light and sound when registering the predefined threshold value of breath hold and position based on the size of the abdominal and/or chest of the human body 200 to be examined with the device 100.

In an embodiment, the microcontroller 52 is further communicatively coupled to an external device 60 and configured to receive the first and the second feedback signals 23, 28 and to display the breath hold level and the position of the human body 200 on a display screen (not shown in Fig. 2). In another embodiment, the external device 60 may be a conventional web-enabled personal computer (laptop, notebook or subnotebook), touch screen display, smart phone (iPhone, Android, Windows), VOIP device, television set-top box, interactive kiosk, personal digital assistant, wireless electronic mail device, tablet computer, medical robotic system or any other device capable of communicating over the Internet or other appropriate communications network with the processing module 30.

In an embodiment, the pouch 40 can be further disposed with a feedback unit to provide the tactile feedback to the human body 200. In an embodiment, an imaging device (not shown in figures) may be conventional X-ray devices, computed tomography (CT), Positron emission tomography-computed tomography (better known as PET-CT or PET/CT), magnetic resonance imaging (MRI) mammography, ultrasound system, C- Arm (C shaped arm), Linac (linear particle accelerator) and any other therapy system.

The working of the device 100 is as following, firstly at least one belt 10 of device 100 is wrapped around human body's 200 abdomen and/or chest. Secondly, the human body is made to lay down on a couch of an imaging device or an interventional procedure as shown in Figure 3. Further, the human body 200 is instructed to inhale and exhale normally, then the belt 10 is locked at a maximum inhale position by means of lock elements 11. In an example, the maximum inhale position may be a comfortable inhale position, wherein the human body 200 can hold the breath for a longer time during imaging or interventional procedure. Consequentially, the first sensor 20 and the second sensor 25 registers the maximum inhale position of the human body 200 and first and second feedback signals 23,28 related to breath hold level and position is provided to the indication unit 53 of the processing module 30. Here, the maximum inhale position of the human body 200 is registered as the predefined threshold value based on the size of the abdominal and/or chest of the human body 200 to be examined. After successful registration of the predefined threshold value, the human body 200 is moved into an imaging modality of the imaging device. Further, the human body 200 is instructed to inhale freely to reach the predefined threshold value, once the predefined threshold value is reached a feedback is provided by the indication unit 53, then the human body is instructed to hold his/her breathe until an image has been taken. Finally, the human body 200 is moved out of the imaging modality to the required position to perform any interventional procedure. The human body 200 is instructed to hold his /her breath for predetermined time as per the predefined threshold value during the interventional procedure. After the procedure is performed, the device 100 will be removed by unlocking the lock elements 11. In an embodiment, the belt 10 can be retained on the human body 200 if further imaging is required for comparing and verifying. The locked belt 10 provides a tangible locus to the human body 200 for reaching the predefined threshold value and to stop further exhalation. Also, the device 100 provides a direct feedback to the human body 200 by the indication unit 53, whereas the operator of the imaging device receives the feedback by the indication unit 53 and/or from the external device 60. In an embodiment, the external device 60 displays the breath hold level and position of the human body 200 with respect to predefined threshold value of the breath hold level and position of the human body 200.

In an exemplary embodiment, the device 100 of the present disclosure comprises of three belts 10 to wrap around the human body 200, each having first and the second sensor 20, 25. The feedback signal 23, 28 are generated from each of the belt 10 of the device 100 having sensors 20, 25, thereby providing a plurality breath hold and position values of the human body 200 to the external device 60. In an embodiment, the values received from each belt 10 are consolidated to facilitate accurate and calibrated value for the breath hold and position of the human body 200 during interventional procedure. The usage of the more number of belts 10 provides precise feed back to the indicating unit 53 and external device 60 and increases ease of operation of the device 100.

In an embodiment, the microcontroller 52 identifies position of the first and second sensor 20, 25. Further, the microcontroller 52 processes and provides the data related to the position of the first and second sensor 20, 25 to display on the external device 60. The displayed data facilitates a graphical representation to the operator for better visualisation and decision making during imaging.

Advantages of the present disclosure are illustrated herein:

The present disclosure relates to a respiration/ breath hold support and position/movement, detection and monitoring device that is simple, easy to operate and affordable.

Effective feedback is provided to the human body to be examined/imaged and the imaging device operator with the application of device of the present disclosure.

The device according to the present disclosure can be utilised for breath hold support, position/ movement detection and monitoring during any known procedures of medical diagnosis or treatment procedures like radiotherapy, biopsy, ablation and similar techniques, wherein the human body is required to hold his/her breathe and position for accurate performance of the said procedures.

The device according to the present disclosure is easy and cost effective to manufacture and maintain. Equivalents:

With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to inventions containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to "at least one of A, B, and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to "at least one of A, B, or C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, or C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B" or "A and B."

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Referral Numerals:

28 Second feedback signal

30 Processing module

40 Pouch

50 Printed circuit board

51 Analog-to-digital converter

52 Microcontroller

53 Indication unit

60 External Device

200 Human body

Claims

The Claims:

1. A breath hold support and position monitoring device ( 100), comprising:

at least one belt (10), having lock elements (1 1) at two ends, wearable around a human body (200);

a first sensor (20) and a second sensor (25) attached to the at least one belt ( 10), to respectively detect breath hold level and position of the human body (200) and to respectively generate a first analog sensor signal (21) and a second analog sensor signal (26) indicative of the breath hold level and position of the human body (200); and

a processing module (30) in communication with the first sensor (20) and the second sensor (25), configured to receive the first and the second analog sensor signal (21 ,

26) , and generate a first feedback signal (23) and a second feedback signal (28) of breath hold level and the position of the human body (200) respectively.

2. The breath hold support and position monitoring device (100) as claimed in claim 1, wherein the processing module (30) further comprises:

an analog-to-digital converter (51) to receive and convert the first and second analog sensor signals (21 , 26) to a corresponding first digital signal (22) and a second digital signal (27); and

a microcontroller (52) configured to process the first and second digital signal (22,

27) and to respectively generate the first and second feedback signals (23, 28) based on comparison of the breath hold level and position value received in the first and second digital signals (22, 27) with a predefined threshold values of breath hold level and position of the human body (200).

3. The breath hold support and position monitoring device ( 100) as claimed in claim 2, wherein the processing module (30) includes an indication unit (53) configured to receive the first and second feedback signals (23, 28) from the microcontroller (52) and indicate the breath hold level and position of the human body (200).

4. The breath hold support and position monitoring device ( 100) as claimed in claim 3, wherein the indication unit (53) comprises at least two light sources and one audio unit respectively to emit light and sound based on the first and second feedback signals (23, 28).

5. The breath hold support and position monitoring device (100) as claimed in claim 4, wherein the microcontroller (52) determines the predefined threshold value of the breath hold level and the position of the human body (200) based on breath hold level and position of the human body (200) recorded for a predetermined time.

6. The breath hold support and position monitoring device (100) as claimed in claim 1, wherein the microcontroller (52) is coupled to an external device (60) configured to receive the first and second feedback signals (23, 28) and to display the breath hold level and position of the human body (200) with respect to the pre-defined threshold breath hold and position of the human body (200).

7. The breath hold support and position monitoring device (100) as claimed in claim 1, wherein the belt (10) comprises a pouch (40) to receive the first and second sensor (20, 25) respectively.

8. The breath hold support and position monitoring device (100) as claimed in claim 6, wherein the microcontroller (52) identifies the location of the first and second sensors (20, 25) and displays a graphical representation indicating the location on the external device (60) to facilitate better visualization and decision making.