KR102315044B1 - Tissue Expander For Breast Reconstruction Being Capable of Real-Time Monitoring and Treatment of Capsular Contracture Based on Current or Voltage Sensor and Patients Information System Associated Therewith - Google Patents

Abstract

The present invention relates to a tissue expander for breast reconstruction capable of real-time spherical contracture monitoring and treatment, including a current or voltage sensor, and a patient information system associated therewith. According to the present invention, the patient or medical staff can easily check and evaluate the spherical contracture that may occur when wearing the tissue expander for breast reconstruction and the resulting inflammation or side effects in real time, even outside the human body, and accordingly, before the occurrence of spherical contracture or When an outbreak occurs, effective treatment and response are possible.

Description

Tissue Expander For Breast Reconstruction Being Capable of Real-Time Monitoring and Treatment of Capsular Contracture Based on Current or Voltage Sensor and Patients Information System Associated Therewith}

The present specification relates to a tissue expander for breast reconstruction capable of real-time spherical construction monitoring and treatment based on an implantable current or voltage sensor, and a patient information system related thereto.

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.

Since tissue expanders or implants are foreign substances during breast reconstruction, 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 a situation in which the tissue expander or the implant is removed and treated after surgery.

Accordingly, the present inventors have intensively studied a method for monitoring and treating spherical contracture during breast reconstruction and inflammation as much as possible in real time, and have arrived at the present invention.

Godbout C, et al. The Mechanical Environment Modulates Intracellular Calcium Oscillation Activities of Myofibroblasts. PLoS ONE 8(5) 2013: e64560

In one aspect, an object of the present invention is to provide a device that enables a patient or medical staff to easily check or evaluate side effects such as spherical contracture and inflammation when wearing a tissue expander for breast reconstruction in real time, even outside the human body .

In another aspect, it is an object of the present invention to provide a system capable of storing information transmitted from the tissue expander in real time and cumulatively and sharing the information by medical staff and patients.

In one aspect, the present invention, in the tissue expander for breast reconstruction, the tissue expander comprises a current or voltage sensor attached to the tissue expander, the current or voltage sensor unit increases calcium ions of surrounding tissue cells adjacent to the tissue expander To provide a tissue expander for breast reconstruction, which detects spherical contracture by measuring a change in current or voltage according to the present invention.

In another aspect, the present invention provides a patient information system that wirelessly transmits to and receives information regarding current or voltage from the tissue expander as described above.

In another aspect, the present invention provides a user terminal, which wirelessly transmits to the tissue expander and receives information about a current or voltage from the tissue expander.

According to the present invention, a patient or medical staff can easily check and evaluate side effects such as spherical contracture and inflammation that may occur when wearing a tissue expander for breast reconstruction in real time even outside the human body, and accordingly, before or occurrence of spherical contracture Effective treatment and response are possible.

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 is shared by the medical staff and the patient, thereby helping to establish a treatment and treatment plan.

1 is a schematic diagram showing a tissue expander for breast reconstruction according to an embodiment of the present invention.
FIG. 2 is an enlarged view of the current or voltage sensor in FIG. 1 .
3A and 3B are schematic views showing a tissue expander further comprising a drug port according to another embodiment of the present invention.
4 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 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.

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

The tissue expander for breast reconstruction of exemplary embodiments of the present invention includes a sensor unit attached to the tissue expander. The sensor unit is to measure a change in current or voltage of surrounding tissue adjacent to the tissue expander, and can detect spherical contracture according to the change in current or voltage, so that real-time monitoring of spherical contracture is possible.

When a tissue expander for breast reconstruction is mounted on a human breast, spherical contracture may occur, and inflammation may occur when the spherical contracture occurs.

This spherical construction occurs when calcium ions outside the cell flow into the myofibroblast.

Specifically, muscle fiber contraction begins with excessive tissue regeneration characteristic of fibrous tissue contraction. Excessive tissue regeneration resulting from tissue contracture gradually increases the extracellular matrix (ECM) stiffness, and the increase in extracellular matrix (ECM) stiffness increases the contractile activity of myofibroblasts and eventually causes contracture.

Contraction cycle of muscle fibroblasts is associated with the period of the direct intracellular calcium oscillation, the oscillation frequency of the calcium ion (oscillation frequency of Ca ^{2 +)} is increased as the mechanical stress (mechanical stress) is increased. Therefore, it means that the mechanical condition changed by the muscle fiber is related to calcium ion vibration (Non-Patent Document 1). That is, when myofibroblasts cause mechanical deformation, contracture, calcium ions are increased.

Calcium ions, which are electrical signals and means to transmit biological information within cells, generate current differences through the process of flowing into all cells.

That is, when the sphere is constructed, a current is generated due to calcium influx flowing into the cell through the ion channel outside the cell (cell inward current).

By attaching a sensor capable of detecting the current difference due to the difference in calcium ion concentration to the site where spheroid contracture occurs, it is possible to detect the change in calcium ions that increase when spheroid contracture occurs and eventually to detect spherical contracture.

In one example, a patch clamping chip may be used to measure an electric flow through an ion channel in a cell membrane.

In the voltage clamp method, when the voltage is constant, the current for the voltage can be obtained (ie, the current sensor), and in the current clamp method, the amount of voltage according to the current can be measured ( i.e. voltage sensor).

As such a patch clamp chip, a known patch clamp chip that can be inserted into the human body can be used. planar) patch clamp chips are preferred.

1 is a schematic diagram showing a tissue expander for breast reconstruction according to an embodiment of the present invention.

As shown in FIG. 1, in one example, the tissue expander has a protrusion 10 formed in one portion, and a perimeter 20 that is inclined or curved outwardly based on the protrusion 10 is integrally formed. a body formed therein. In addition, the body may include at least one port part 30 for injecting an expansion solution and/or a therapeutic drug to be injected into the tissue expander.

In addition, one or a plurality of sensor units 100 may be formed in the tissue expander.

In an example, a plurality of current or voltage sensor units 100 may be spaced apart from each other on the surface of the tissue expander.

It is preferable that the sensor unit 100 is formed in a portion of the tissue expander that is most likely to come into contact with human tissue in terms of increasing sensing efficiency. Accordingly, the sensor unit 100 may be located on the surface of the tissue expander. At this time, it is preferable that each sensor unit 100 is formed on at least the protrusion 10 and the peripheral portion 20 . As an example, one sensor unit 100 may be formed on the protrusion 10 , and one sensor unit 100 may be formed on both sides of the peripheral portion 20 .

FIG. 2 is an enlarged view of the current or voltage sensor in FIG. 1 .

2, the sensor unit 100 of the tissue expander includes a biocompatible hydrogel layer formed on at least a portion of the tissue expander surface: and one or more current or voltage sensors 150 attached to the hydrogel layer. ; may be included. In this way, when the sensor is packaged in the biocompatible hydrogel layer, data on the internal state of the human body can be obtained through the sensor, while being harmless to the human body through the biocompatible packaging.

In one example, the current or voltage sensor 150 may include a known patch clamp chip as described above.

In an example, the measured current or voltage signal may be wirelessly transmitted to an external user terminal and/or a patient information system to be described later through a medical device radio communication service (MedRadio) frequency band.

In one example, the sensor may be charged using known wireless power transfer (WPT) technology.

In one example, the sensor may be manufactured as a single chip by embedding an ultra-small current or voltage sensor of, for example, 0.4x1.0 mm. For example, the current or voltage sensor may be manufactured as a chip-type structure in which an antenna for wireless communication, a coil for wireless charging, and a secondary battery are integrated together with the sensor. The coil for wireless charging of the structure receives power from the outside and delivers power to the secondary battery. In addition, an external base station for wireless power supply may be additionally provided.

In one example, when contracture is detected through the sensor, the medical staff injects the drug through the drug port so that the tissue expander releases the drug to the surrounding tissue.

3A and 3B are schematic views showing a tissue expander further having a drug port according to another embodiment of the present invention.

3A and 3B , for drug injection/release, the tissue expander body may additionally include a drug port 30 together with an expansion port 40 .

The expansion port 40 includes an injection port 41 through which the expansion solution is injected and a storage unit 42 capable of storing the injected expansion solution.

The drug port 30 for drug injection/release is a port formed separately from the expansion port 40 and may include a soft inlet 34 and a rigid partitioning wall 35, and the inlet 34 is The drug injected through the separation wall 35 moves through the hole 36 present on at least one side and moves to the drug release channel 31 at the end of the body through the drug transfer channel 33, and a plurality of drug outlets 32 ) through the body. At least two or more protruding sutures 50 for fixing and supporting the drug release channel 31 may be provided.

In this way, the current or voltage signal collected from the sensor is transmitted to the patient information management system or user terminal to be described later, and if it is determined that spherical construction has occurred or is expected based on the signal, after the doctor's treatment, the drug port 30 ) through the injection of the drug, thereby allowing the drug to be released into the human tissue.

The drug to be injected into the drug port 30 may be a drug injected for the treatment of capsular contracture that may occur due to a tissue expander implanted in the body, for example, a fibrosis inhibitor, a proliferation inhibitor, an anti-ischemic complex. , 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.

Specifically, the growth inhibitory agent is tamoxifen, halofuginone, vitamin C, asiaticoside, cyclosporine A, homoharringtonine, vitamin A, D-penicilla. Min (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), and heparin or suramin, but is not limited thereto.

Meanwhile, in other exemplary embodiments of the present invention, there is provided a patient information system that wirelessly transmits to the tissue expander and receives information about voltage from the tissue expander.

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

Fig. 4 schematically shows a patient information management system comprising a user terminal, eg, a mobile, and eg a hospital Electronic Medical Record (EMR) recording server associated with a tissue expander according to an embodiment of the present invention. For reference, the system also does not exclude that it includes a user terminal.

In one example, the patient information system and/or user terminal may provide an alarm signal when the current or voltage received from the sensor is a contractile-generated current or voltage (or a contractive-generated current or voltage range).

Here, the contracture generation current or voltage (or a range thereof) may be a current or voltage value (or a range thereof) when a medical practitioner diagnoses an actual spherical contracture among past accumulated current or voltage values. Alternatively, the build-up generated current or voltage (or its range) may mean a value deviating from a preset normal range (or when deviating values form a predetermined range).

As described above, real-time spherical construction monitoring is possible by the tissue expander equipped with a current or voltage sensor, and this result can be provided to a patient information management system of a hospital or a user terminal of a medical staff and/or a patient in real time and cumulatively. have. As a result, patients or medical staff can easily check and evaluate side effects such as spheroid contracture and inflammation in real time even outside the human body, thereby enabling pre-existing treatment and response before spheroid contracture occurs, and treatment and treatment plan It can also help with setting up.

10: protrusion
20: perimeter
30: drug port
31: drug release channel
32: drug outlet
33: drug transport channel
34: drug port inlet
35: drug port dividing wall
36: hole
40: expansion port
41: expansion port inlet
42: expansion liquid storage unit
50: protruding suture
100: sensor unit
150: sensor
00: tissue expander
P: port

Claims (11)

In the breast reconstruction tissue expander inserted into the breast during breast reconstruction,
The tissue expander comprises a current or voltage sensor attached to the tissue expander surface adjacent to surrounding tissue,
The current or voltage sensor unit measures a current or voltage change according to an increase in calcium ions in surrounding tissue cells adjacent to the tissue expander to detect spherical construction by the tissue expander for breast reconstruction, a tissue expander for breast reconstruction.
According to claim 1,
The tissue expander includes a body in which a protrusion is formed in one portion, and a perimeter formed to be inclined or curved outwardly based on the protrusion is integrally formed,
The body includes a port for injecting the expansion solution to be injected into the tissue expander,
A tissue expander for breast reconstruction comprising one or a plurality of current or voltage sensors positioned on at least one side of the body surface.
3. The method of claim 2,
The sensor unit comprises a biocompatible hydrogel layer and one or more current or voltage sensors attached to the hydrogel layer, a tissue expander for breast reconstruction.
4. The method of claim 3,
wherein the current or voltage sensor comprises a patch clamp chip.
According to claim 1,
The sensor unit wirelessly transmits a measured current or voltage signal to an external device, a tissue expander for breast reconstruction.
According to claim 1,
The sensor unit includes an antenna for wireless communication, a coil for wireless charging, and a chip-type structure in which a secondary battery is integrated with the sensor, a tissue expander for breast reconstruction.
According to claim 1,
The tissue expander further comprises a drug port in the body, a tissue expander for breast reconstruction.
8. The method of claim 7,
A drug release channel including a plurality of drug outlets is provided at the peripheral end of the tissue expander,
The drug port and the drug release channel are connected to the drug movement channel, breast reconstruction tissue expander.
In wireless transmission with the tissue expander of any one of claims 1 to 8,
receiving information regarding current or voltage from the tissue expander.
In wireless transmission with the tissue expander of any one of claims 1 to 8,
A user terminal for receiving information about current or voltage from the tissue expander.
11. The method of claim 10,
and providing an alarm signal when the current or voltage received from the tissue expander is in a value or range of occurrence of spherical contracture.

Images