KR20220069158A - Tissue Expander Capable of Real-Time Monitoring and Post-Management Based on Multi-Functional Sensor and Patients Information System Associated Therewith - Google Patents

Abstract

Disclosed are a tissue expander capable of real-time monitoring and post-management based on a multifunctional sensor and a patient information system associated therewith which insert an electronic device including a sensor and a communication module that perform radio-based communication within the tissue expander, measure displacement such as an inclination or the like of the tissue expander of a patient, and additionally measure a temperature, pressure and the like of the tissue expander, thereby performing side effects and post-management after a tissue expander insertion procedure.

Description

Tissue Expander Capable of Real-Time Monitoring and Post-Management Based on Multi-Functional Sensor and Patients Information System Associated Therewith

This specification relates to a tissue expander for breast reconstruction, such as a multifunctional smart sensor-based real-time sphere construction, side effects monitoring such as inflammation, delivery of individual prescriptions or recommendations, and follow-up management, such as treatment, and related patient information systems. will be.

Recently, as life expectancy after treatment due to breast-related diseases such as breast cancer increases and the cosmetic aspect is emphasized, various methods for reconstructing the breast after mastectomy are in use.

As an example of the breast reconstruction method as described above, a breast reconstruction surgery in which a tissue expander is primarily inserted to increase the soft tissue to a level where an implant can be inserted, and then secondarily the tissue expander is replaced with a permanent implant is used.

When performing breast reconstruction, tissue expanders or implants are foreign substances, so they may enter the breast area and cause spherical contracture. For reference, spherical contracture is a symptom in which a thick film is formed around the inserted tissue expander or implant, which gradually hardens the tactile feel, and thus is accompanied by inflammation. In the case of side effects such as inflammation, it is usually followed by surgery to remove and treat the tissue expander or implant.

Accordingly, the present inventors have intensively studied a method for monitoring and treating spherical contracture and inflammation as much as possible in real time in a tissue expander used for breast reconstruction or other surgeries that require expansion of skin or surrounding soft tissue, and have arrived at the present invention.

US Patent Application Publication No. 2011-0152913

In one aspect, an object of the present invention is to insert an electronic device including a sensor and a communication module for performing wireless-based communication in the tissue expander and measure the displacement such as the inclination of the patient's tissue expander, as well as the temperature of the tissue expander, It is to provide a device that can perform side effects and follow-up management after tissue expander insertion procedure by measuring pressure and volume.

In another aspect, an object of the present invention is to provide information necessary for real-time and cumulative storage, analysis, and diagnosis of the information transmitted from the tissue expander, and to help in the establishment of treatment and treatment plans as medical staff and patients share It is to provide a system that can give.

In one aspect, the present invention provides a tissue expander, the tissue expander comprising a sensing and communication module attached to the tissue expander, the sensing and communication module comprising at least a displacement sensor, a temperature sensor, a pressure sensor, and a volume Provided is a tissue expander for breast reconstruction, which may further include one or more of the sensors.

In another aspect, the present invention provides a patient information system in wireless communication with the aforementioned tissue expander.

In another aspect, the present invention provides a user terminal, which wirelessly transmits and receives the aforementioned tissue expander.

According to the present invention, state information such as spherical construction and subsequent inflammation that may occur when wearing a tissue expander for breast reconstruction, etc., and positional movement, deformation, or rupture of the tissue expander can be provided to a patient or medical staff in real time even outside the human body. It can be easily identified and evaluated, thereby enabling effective treatment and response before or when side effects, etc. occur.

In addition, the information transmitted from the tissue expander is stored in real time and cumulatively in the hospital system and/or the user terminal of the medical staff or patient, and provides information necessary for analysis and diagnosis, and treatment and treatment plan as the medical staff and the patient share It can help establish, patients can check individual prescriptions, and medical staff can deliver recommendations.

1A is a schematic diagram illustrating a sensor and a communication unit including a plurality of sensors, a Bluetooth device including an antenna, a processor, a displacement sensor, a PCB board installed with a switch, and a battery according to an exemplary embodiment of the present invention.
FIG. 1C is a diagram illustrating the PCB circuit of FIG. 1A by way of example.
1D is a schematic diagram illustrating a sensing and communication module in which the sensor and communication unit of FIG. 1A are embedded in a housing;
Figure 2 is a schematic diagram showing that the sensor and the communication module is installed in the tissue expander according to an embodiment of the present invention.
3 schematically illustrates a user terminal and a patient information management system associated with a tissue expander according to an embodiment of the present invention.
4 is a diagram of data transmission between a tissue expander and an external device (eg, a smart phone) in an embodiment of the present invention.

Term Definition

In this specification, terms such as “unit”, “module”, “device”, “terminal”, “sensor”, and “system” may refer to hardware as well as a combination of software driven by the corresponding hardware. For example, the hardware may be a data processing device including a CPU or other processor. In addition, the software driven by the hardware may be a program such as a running process, an object, an executable file, a thread of execution, a calculation program, and the like.

In this specification, the sensing and communication module refers to a device in which a sensor and a communication unit are mounted on a housing.

In this specification, the sensor and the communication unit mean parts including the sensor and a communication means capable of transmitting and receiving information sensed by the sensor to and from the outside.

As used herein, the displacement sensor is used to measure dynamic variables such as acceleration, impact, and tilt displacement of a tissue expander, and may include, for example, a tilt sensor, an acceleration sensor, a gyro sensor, and the like.

In the present specification, the tissue expander is used for breast reconstruction or other surgeries that require expansion of the skin or surrounding soft tissue, and it is placed under the skin and expanded (expanded) by injecting an expansion solution such as physiological saline from the outside at regular intervals to expand the skin. For example, it means a bag-shaped device made of a material such as silicon to be stretched.

In the present specification, the term "inside the tissue expander" means the side of the space in which the expansion solution is injected into the tissue expander.

In the present specification, the term "outside the tissue expander" refers to the side of the skin tissue in contact with the tissue expander.

In this specification, the predefined problem occurrence value or range means a value or range of sensing information defined in advance when there is a problem requiring medical intervention, such as spherical contracture or inflammation, which may occur due to insertion of a tissue expander. .

Description of Example Implementations

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

The tissue expander of exemplary embodiments of the invention includes a sensing and communication module attached to the tissue expander.

The sensing and communication module includes a sensor and a communication unit, and the sensor and communication unit include at least a displacement sensor for measuring the displacement of the tissue expander, and a temperature sensor for measuring the temperature of the tissue expander and the pressure of the tissue expander It further includes one or more of the pressure sensors, and preferably includes all three sensors.

As described above, if the displacement sensor for measuring the displacement of the tissue expander is included, there is an advantage in that it is possible to detect a change in the position of the tissue expander in real time and respond thereto in real time.

The sensor and the communication unit may further include a communication unit including an antenna capable of communicating with the outside, a timer, a processor for processing sensed information, and an on/off switch. The timer may be used during processing of a processor, such as transmitting data to the outside at a regular cycle or measuring a sensor periodically. The on/off switch may be turned on/off according to a control signal from an external terminal or a patient linkage system.

1A is a schematic diagram illustrating a sensor and a communication unit including a plurality of sensors, a Bluetooth device including an antenna, a processor, a displacement sensor, a PCB board installed with an on/off switch, and a battery according to an exemplary embodiment of the present invention; to be. Figure 1b is a schematic diagram showing the main configuration of the sensor and communication unit of Figure 1a. FIG. 1C is a diagram illustrating the PCB circuit of FIG. 1A by way of example. 1D is a schematic diagram illustrating a sensing and communication module in which the sensor and communication unit of FIG. 1A are embedded in a housing.

1A to 1C , in an embodiment of the present invention, a plurality of sensors, that is, a pressure sensor 11 , a displacement sensor 14 , and a temperature sensor are included on a single PCB board 20 of the sensor and communication unit 100 . (not shown), a volume sensor (not shown) and a Bluetooth device including an antenna 12 , a processor 13 , and an on/off switch 15 may be mounted thereon.

In one non-limiting embodiment, the corresponding PCB board 20 is, for example, a board having a circular shape, and may have a diameter of approximately 20 to 30 mm. The PCB board may be laminated in one or a plurality, for example, a plurality of layers may be laminated in 2 to 7 layers, but if it is preferably composed of one sheet, the entire device can be miniaturized.

In addition, the sensor and communication unit may further include a battery 10 in addition to the PCB board 20 .

Meanwhile, the pressure sensor 11 may be configured to protrude more outside than other sensors, as will be described later, in order to more easily measure the pressure inside the tissue expander.

In one embodiment, the sensors described above preferably include at least all of a temperature sensor, a pressure sensor and a displacement sensor.

The temperature sensor is to measure the temperature constant when a spherical contracture or inflammation occurs by measuring the temperature of the tissue expander, and a known temperature sensor can be used, and a type combined with a pressure sensor can be used. have.

The pressure sensor is to measure the tissue dilator pressure, preferably the pressure applied to the inside of the tissue dilator, to measure the pressure change when spherical contracture or inflammation occurs due to this, and a known pressure sensor can be used, A type combined with a temperature sensor may be used.

In one non-limiting example, it may further include a sensor for measuring the internal volume of the tissue expander. A known volumetric sensor may be used as the volumetric sensor, and a type combined with a pressure sensor and/or a temperature sensor may be used.

In a non-limiting example, the temperature, pressure, and volume sensor may be a sensor in which a corresponding function is combined into one sensor, and may be selected in consideration of high compatibility with other devices and low power and low voltage characteristics, and also has a waterproof function within the sensor. It is appropriate to have As such a sensor, for example, the MS5540C sensor can be used.

The displacement sensor is used to measure dynamic variables such as acceleration, impact, and tilt displacement of the tissue expander, and may transmit state information such as position movement, deformation, and rupture of the tissue expander. In addition, it is possible to measure the change in the position of the tissue expander in the event of spheroid contracture or inflammation resulting therefrom. As the displacement sensor, for example, a known displacement sensor such as a tilt sensor, an acceleration sensor, or a gyro sensor may be used. As a non-limiting example, for example, the LIS2DW12 may be used as a tilt sensor.

The above-described sensors may be configured to enable bidirectional communication through a network. The communication method through the network may include various communication methods through which the object and the object can network, and may be wireless communication, 3G, 4G, particularly preferably 5G. In addition to this, it may be a core network integrated with a wireless mobile communication network or mobile Internet, It may be, but is not limited to, an open computer network that provides Domain Name System), Simple Mail Transfer Protocol (SMTP), and the like.

For example, networks include Local Area Network (LAN), Metropolitan Area Network (MAN), Global System for Mobile Network (GSM), Enhanced Data GSM Environment (EDGE), High Speed Downlink Packet Access (HSDPA), W-CDMA (W-CDMA). Wideband Code Division Multiple Access), CDMA (Code Division Multiple Access), TDMA (Time Division Multiple Access), Bluetooth, BLE (Bluetooth Low Energy), Zigbee, Wi-Fi, VoIP (Voice over Internet Protocol), LTE Advanced, IEEE802.16m, WirelessMAN-Advanced, HSPA+, 3GPP Long Term Evolution (LTE), Mobile WiMAX (IEEE 802.16e), UMB (formerly EV-DO Rev. C), Flash-OFDM , iBurst and MBWA (IEEE 802.20) systems, HIPERMAN, Beam-Division Multiple Access (BDMA), Wi-MAX (World Interoperability for Microwave Access), and a communication network by at least one communication method selected from the group consisting of ultrasound-assisted communication. may be referred to, but is not limited thereto.

Factors such as battery capacity, service life, and communication distance of the sensor and communication module should be considered when communication is connected between a sensor and a communication module including the above-described sensors and an external terminal or system. In this aspect, in a non-limiting embodiment, it is possible to preferably use Bluetooth Low Energy (BLE) including an advertising mode by a beacon. Also, for this, the sensor unit may include a beacon. A beacon is a wireless communication device capable of transmitting necessary data by automatically recognizing a terminal such as a smart device in a short distance. For reference, NFC operates at a short distance within 10 cm, but the distance is short to apply it to the tissue expander of the present invention, but the beacon can operate at a distance of up to 50 m.

4 is a data transmission diagram between a tissue expander and an external device (eg, a smart phone) in an embodiment of the present invention.

Referring to FIG. 4 , it is possible to continuously provide sensed data to nearby terminals through the above-described beacon, and when two-way communication such as setting change is necessary, a BLE (Blue tooth low energy) connection mode is executed and send/receive necessary data and terminate the connection. Thereafter, data periodically sensed through a beacon may be provided to neighboring terminals.

In one non-limiting embodiment, the details of data that can be transmitted from the tissue expander to the beacon may be temperature, pressure, acceleration, transmission cycle, power supply voltage, date and time, and the like, for example, as described in the following table.

Item data range resolution
(recognizable value) unit number of bytes temperature -20~80 0.1 ℃ 2 pressure 750 to 1100 0.1 mbar 2 acceleration ±2000 0.224 mg 6 transmission frequency 1 to 255 One min One power supply voltage 2-3.5 0.1 V One date month, day, hour, minute minute - 4 Sum 16

In one non-limiting embodiment, MIC (Medical Implant Communication) with the highest biotissue permeability may be used for bidirectional communication, and connection and adjustment in general-purpose 5G portable terminals (smartphones, tablet PCs, etc.) For example, the 2.4Ghz band may use BLE communication to make it possible.

Also, in one non-limiting embodiment, the sensors may be charged using known wireless power transfer (WPT) technology.

Referring to FIG. 1D , the above-described sensor and communication unit 100 may be embedded in the housing 200 , wherein a part of the pressure sensor 11 is configured so that a part is drawn out of the housing 200 rather than Preferred for accurate pressure measurement. The housing 200 may be made of, for example, poly lactic acid (PLA) material, and the sensor and communication module may be configured in such a way that the sensor and the communication unit 100 are embedded in the housing 200 .

In addition, the upper portion of the housing 200 in which the sensor and communication unit 100 are embedded, can be finished with a cover 300 made of medical silicone or epoxy material that can transmit and receive an antenna and can be waterproof.

Meanwhile, in exemplary embodiments of the present invention, one or a plurality of sensors and communication modules M may be formed in the tissue expander.

Figure 2 is a schematic diagram showing that the sensor and the communication module is installed in the tissue expander according to an embodiment of the present invention. That is, FIG. 2 shows a tissue expander (E) for breast reconstruction as an example. In the tissue expander, an expansion solution such as physiological saline is injected through the port (P).

The sensor and communication module (M) of the present invention is installed on the inside of the tissue expander (E), that is, on the side of the space in which an expansion solution such as physiological saline enters the inside of the tissue expander, not the part in contact with human tissue among the tissue expanders. It is preferred in terms of both temperature, pressure and displacement measurements.

In one non-limiting example, a camera unit (C) including a camera may be mounted on the outside of the tissue expander, for example, on the transparent port (P) side. The camera unit captures the situation on the skin side adjacent to the tissue expander in real time, and this information is transmitted to the above-described sensor and communication module (M) and then transmitted together with other information, or the camera unit itself is an external terminal or It may be configured to transmit and receive to and from the system.

The camera unit may include a battery in the camera unit, a camera including a micro lens, a communication unit in the camera unit including an antenna, and a processor in the camera unit. The camera sub-battery may use an ultra-small battery that is the same as or smaller than that used for the sensor and communication module (M), and may be charged by a wireless power charging method. The image or video information captured by the camera lens may be used as information for a more accurate determination of the medical staff about the tissue condition around the tissue expander together with displacement information such as temperature, pressure, volume, and gradient change. In other words, it is possible to check the information photographed with the lens in real time from the outside to check the in vivo reaction that occurs after implantation in the patient's body in real time, so that an abnormal symptom can be treated immediately.

In one non-limiting example, the camera may in particular be a thermal imaging camera. When the thermal imaging camera is used in this way, it is possible to more accurately determine the temperature of the tissue around the tissue expander in parallel with the temperature measurement by the temperature sensor.

Also, in one non-limiting example, a pH sensor unit including a pH sensor for measuring a change in pH may be included on the outside of the tissue expander. That is, since a change in pH may occur when inflammation occurs due to spheroid contracture, it is possible to additionally determine the situation such as spheroid contracture and inflammation by measuring this. A known pH sensor may be used as the pH sensor.

In one non-limiting example, the pH sensor unit applied to the outside of the tissue expander may include a biocompatible hydrogel layer formed on at least a portion of the outer surface of the tissue expander and one or more pH sensors attached to the hydrogel layer. In this way, when the pH sensor is packaged in the biocompatible hydrogel layer, the pH data can be obtained through the pH sensor, but it is harmless to the human body through the biocompatible packaging.

In one non-limiting example, it is necessary to adjust the position of the tissue expander or expand or contract the inside of the physiological tissue expander based on information collected through the displacement sensor, pressure sensor, temperature, and volume sensor. To this end, for example, a separate gas accommodating part may be included in the tissue expander in addition to the expansion solution injection part, and expansion or contraction may be performed by injecting gas into the gas accommodating part. In addition, the expansion or contraction of the gas receiver can be monitored by the camera in the tissue expander described above.

On the other hand, in one non-limiting embodiment, when it is determined that spherical contracture or inflammation is detected through the sensor, the medical staff injects the drug through the drug delivery unit so that the tissue expander releases the drug to the surrounding tissue. To this end, as a tissue expander, a tissue expander having a drug delivery unit may be used. For example, if the data collected from the sensor is transmitted to the patient information management system or the user terminal, and it is determined that spherical contracture or inflammation has occurred or is expected based on the signal, after the doctor's treatment, the drug is injected into the drug delivery unit and the drug may be released into the human tissue along the drug delivery unit.

The drug injected into the drug delivery unit may be a drug injected for the treatment of capsular contracture, inflammation, etc. that may occur due to a tissue expander implanted in the body, for example, a fibrosis inhibitor, a proliferation inhibitor, an anti ischemic complexes, anticoagulants, and the like.

Specifically, the fibrosis inhibitor may include pirfenidone, mitomycin, acetylsalicylic acid, genistein, selenocystine, or tranilast. However, the present invention is not limited thereto.

The growth inhibitory agent is specifically, tamoxifen (tamoxifen), halofuginone (holofuginone), vitamin C, asiaticoside (asiaticoside), cyclosporine

A (cyclosporine), homoharringtonine (homoharringtonine), vitamin A, D- penicillamine (Dpenicillamine) or liposomes may be mentioned, but is not limited thereto.

Specifically, the anti-ischemic complex may include Necrox-5 or Necrox-7, and the anticoagulant is specifically, a tissue type plasminogen activator, urokinase (thrombolytic agent), Heparin or suramin may be mentioned, but is not limited thereto.

Another exemplary embodiment of the present invention provides a patient information system that wirelessly transmits/receives to and/or transmits information to and/or from the tissue expander as described above.

Further, another exemplary embodiment of the present invention provides a user terminal that wirelessly transmits/receives to and from the tissue expander and transmits/receives information to and/or from the tissue expander.

3 schematically illustrates a user terminal and a patient information management system associated with a tissue expander according to an embodiment of the present invention.

In one example, the patient information system may be an intelligent computing system that analyzes information of a tissue expander and assists in diagnosis. In addition, it is possible to provide individual prescriptions for each patient to the user terminal of the patient.

In one example, the patient may check the contents of the medical team's prescription and receive recommendations through the terminal linked to the patient information system.

In an example, when it is determined that a problem such as spherical contracture or inflammation has occurred based on the information received from the sensor, the patient information system and/or the user terminal may provide an alarm signal.

The determination may be a value (or a range thereof) when a medical staff diagnoses that a problem, such as spherical contracture or inflammation, has actually occurred among past accumulated data. Alternatively, a problem may be defined as a value deviating from a preset normal range (or when deviating values form a predetermined range).

On the other hand, based on the above-mentioned alarm or sensing information, a doctor's prescription may be given, and accordingly, the tissue expander can be expanded by removing the expansion solution in the tissue expander, or the tissue expander can be expanded or other treatment can be performed by adding more expansion solution. have.

As described above, according to the tissue expander of the exemplary embodiments of the present invention, it is possible to monitor status information such as side effects such as real-time spherical contracture and inflammation, movement, deformation, and rupture of the tissue expander, and the results are real-time and cumulative In general, it may be provided to a patient information management system of a hospital or a user terminal of a medical staff and/or a patient. As a result, the patient or medical staff can easily check and evaluate status information, such as side effects such as spheroid construction and inflammation, in real time, even outside the human body, thereby enabling pre-existing treatment and response, and establishing treatment and treatment plans. can help too. In addition, patients can check individual prescriptions, and medical staff can deliver recommendations.

10: battery
20: PCB
11: pressure sensor
12: Bluetooth communication device including an antenna
13: Processor
14: gyro sensor
15: on/off switch
100: sensor and communication unit
200: housing
300: cover
M: sensing and communication module
P: expansion fluid injection port
C: camera unit
E: Tissue expander for breast reconstruction

Claims (15)

In the tissue expander,
The tissue expander includes a sensing and communication module attached to the tissue expander,
wherein the sensing and communication module comprises a displacement sensor.
According to claim 1,
The sensing and communication module further includes at least one of a temperature sensor, a pressure sensor, and a volume sensor,
wherein the displacement sensor is at least one of a tilt sensor, an acceleration sensor, and a gyro sensor.
3. The method of claim 2,
The tissue expander is a tissue expander for breast reconstruction,
The sensing and communication module is installed on the inside of the tissue expander for breast reconstruction, tissue expander.
4. The method of claim 3,
The sensing and communication module,
sensor and communication unit;
a battery for providing power to the sensor and the communication unit;
a housing into which the sensor and the communication unit and the battery are inserted; and
Including, a tissue expander that covers one side of the housing.
5. The method of claim 4,
The sensor and communication unit,
circuit board;
a Bluetooth communication device including an antenna mounted on the circuit board;
a displacement sensor, a temperature sensor, and a pressure sensor mounted on the circuit board;
A tissue expander comprising; a processor mounted to the circuit board.
6. The method of claim 5,
wherein the pressure sensor at least partially protrudes outside the housing.
5. The method of claim 4,
The sensing and communication module communicates with the outside via a Bluetooth low power (BLE) network including a discovery mode (advertising mode) by a beacon, tissue expander.
4. The method of claim 3,
A camera unit is provided on the transparent port side of the tissue makeup device for breast reconstruction,
The camera unit, including a camera including a micro lens, and a camera communication unit for transmitting and receiving information photographed from the camera with the sensing and communication module or an external device, tissue expander.
4. The method of claim 3,
A pH sensor unit is included on the outside of the tissue cosmetic for breast reconstruction,
The pH sensor unit includes a biocompatible hydrogel layer formed on a portion of the outer surface of the tissue expander; and one or more pH sensors attached to the hydrogel layer.
According to claim 1,
The tissue expander further comprises a drug delivery unit.
A patient information system in wireless communication with the tissue expander of any one of claims 1 to 10.
12. The method of claim 11,
The patient information system provides auxiliary information related to diagnosis by analyzing information received from the tissue expander.
11. A user terminal in wireless communication with the tissue expander of any one of claims 1 to 10.
14. The method of claim 13,
The user terminal is linked to the patient information system, the user terminal to provide one or more of the prescription contents and recommendations of the medical staff.
14. The method of claim 13,
A user terminal that provides an alarm signal when information received from the tissue expander is within a predefined problematic value or range.

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