WO2024106697A1 - Système de détection de vessie en temps réel par l'intermédiaire d'un élément de capteur bio-implantable - Google Patents

Système de détection de vessie en temps réel par l'intermédiaire d'un élément de capteur bio-implantable Download PDF

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WO2024106697A1
WO2024106697A1 PCT/KR2023/011978 KR2023011978W WO2024106697A1 WO 2024106697 A1 WO2024106697 A1 WO 2024106697A1 KR 2023011978 W KR2023011978 W KR 2023011978W WO 2024106697 A1 WO2024106697 A1 WO 2024106697A1
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Prior art keywords
bladder
sensor
real
sensing system
clause
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PCT/KR2023/011978
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English (en)
Korean (ko)
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박스티브
박성민
오병국
임영수
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한국과학기술원
포항공과대학교 산학협력단
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Priority claimed from KR1020230096402A external-priority patent/KR20240071300A/ko
Application filed by 한국과학기술원, 포항공과대학교 산학협력단 filed Critical 한국과학기술원
Publication of WO2024106697A1 publication Critical patent/WO2024106697A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A61B5/391—Electromyography [EMG] of genito-urinary organs

Definitions

  • the present invention relates to a real-time bladder sensing system using a bio-implantable sensor element, and more specifically, to a real-time bladder sensing system using a bio-implantable sensor element that can monitor bladder physiological phenomena in real time using a biocompatible element. will be.
  • the human urinary bladder is a musculomembranous sac located in the anterior portion of the pelvic cavity that functions as a urine reservoir, receives urine through the ureters, and excretes it through the urethra.
  • the bladder is located behind the pelvic bone (pubic symphysis) and is connected to the upper posterior end by a draining tube called the urethra that drains outside the body.
  • the urinary bladder is subject to various diseases and injuries that cause the urinary bladder to deteriorate in patients. For example, bladder exacerbations may be due to infectious diseases, neoplasms, and developmental abnormalities.
  • Non-Patent Document 1 Expandable and Implantable Bioelectronic Complex for Analyzing and Regulating Realtime Activity of the Urinary Bladder Paper DOI: https://advances.sciencemag.org/content/6/46/eabc9675 (2020.11.11)
  • the problem to be solved by the present invention is to provide a real-time bladder sensing system and method.
  • the present invention is a real-time bladder sensing system using a bio-implantable sensor element, which includes a sensor unit attached to the bladder; and an analysis unit that analyzes the signal received from the sensor.
  • the sensor unit can simultaneously sense EMG and stainless steel.
  • the sensor unit is formed on a hydrogel substrate containing polyacrylamide and is attached to the bladder through the hydrogel substrate.
  • the analysis unit filters the peak signal from the strain sensing signal and then predicts urination time therefrom.
  • the analysis unit calculates the root-mean-square deviation of the EMG sensing signal, determines the timing of urination, tracks the change in the number of urinations, and predicts overactive bladder. do.
  • the analysis unit determines an EMG RMS signal point having a value of 2 x (average EMG RMS) or more as the point of urination.
  • the analysis unit receives the EMG and strain signals and integrates them to predict bladder physiology.
  • the physiological phenomenon of the bladder is the timing of urination and whether there is an overactive bladder.
  • the EMG sensor includes three electrodes formed on a radial island substrate, where the radial island substrate is bonded to the hydrogel substrate.
  • an anti-swelling coating layer is formed on the sensor unit.
  • the anti-swelling coating layer includes an acrylic gate-based material, and the real-time bladder sensing system has a lower modulus compared to the bladder in the human body.
  • the present invention also provides a sensor for the bladder sensing system described above, wherein the sensor is attached to the bladder through a hydrogel-based adhesive.
  • a sensor system that is biocompatible and has adhesive properties is provided that can accurately monitor bladder physiology using biocompatible materials.
  • the sensor system according to the present invention is composed of soft materials with excellent biocompatibility and uses materials that can minimize side effects even when inserted into the body. It minimizes reaction speed and hysteresis and provides reliability even when mechanical stimulation is applied. It can work.
  • FIG. 1 is a schematic diagram explaining a manufacturing method according to an embodiment of the present invention.
  • Figure 2 is a photograph after the sensor manufactured according to the present invention is attached to the bladder.
  • Figure 3 is a block diagram of a sensing system according to the present invention.
  • Figure 4 is a diagram illustrating a sensing system and a sensing method manufactured according to an embodiment of the present invention.
  • Figure 5 is a graph showing the relative volume change in PBS with and without an anti-swelling coating.
  • Figure 6 is strain-stress curves of PAAm with and without anti-swelling coating.
  • Figure 7 is a graph of adhesion when a conventional silicone rubber (Ecoflex-0020) is used as an adhesive on the same substrate (PAAm) and when a hydrogel-based adhesive is used.
  • a conventional silicone rubber (Ecoflex-0020) is used as an adhesive on the same substrate (PAAm) and when a hydrogel-based adhesive is used.
  • Figure 8 shows the results of testing the in vitro cytotoxicity of strain sensor and EMG sensor materials formed on a hydrogel substrate using HEK293 cells.
  • Figure 9 is an in-vivo protocol image of bladder contraction and expansion using a rat model
  • Figure 10 shows a strain sensor attached to the bladder by connecting a rubber tube to the rat bladder to induce a repetitive urination process through injection and discharge of liquid. and the sensing result of the EMG sensor.
  • Figure 11 shows the signal-to-noise ratio (SNR) compared to the existing EMG sensor by coating the EMG sensor of the sensor system according to the present invention with platinum black (PtB) to increase the overall cross-sectional area of the sensor. This is the result of improvement.
  • SNR signal-to-noise ratio
  • Figure 12 shows results showing higher EMG activity in the bladder distension section when comparing the normal bladder section and the bladder distension section.
  • Figure 13 shows the results of tracking the amount of urination and timing of urination before (normal state) and after (overactive bladder inducing drug) injection (overactive bladder inducing drug).
  • Figure 14 shows the results of comparing and analyzing the results of Figure 13 in terms of the amount of urination per time and the time between urinations in the normal section and the overactive bladder induction section.
  • Figure 15 shows the results of tracking physiological indicators (urination volume, intravesical pressure) in the sensitive bladder induction section.
  • Figure 16 shows the measurement results of the tension sensor and EMG sensor in the overactive bladder induction section.
  • Figure 17 shows the results of extracting data near the time of urination and taking the average based on the time of urination.
  • Figure 18 shows the results of quantitative analysis of the results of Figure 17.
  • Figure 19 is an image of the surgical protocol for implanting the hydrogel-based implantable sensor developed by our research team using a minimally invasive laparoscopic robotic implant surgical instrument.
  • Figure 20 is an image of the minimally invasive laparoscopic robot implantation surgery process using an actual pig
  • Figure 21 shows the surgical process in which the hydrogel-based implantable sensor developed by our research team is implanted and attached to the pig bladder using laparoscopic robot implantation surgery.
  • the image shown, Figure 22, is an image showing the pig's repetitive urination process and the results of the strain sensor and EMG sensor sensed during the urination process reflect the actual pig's urination process.
  • this component may be installed in direct connection or contact with the other component.
  • they may be installed at a certain distance, and in the case where they are installed at a certain distance, there may be a third component or means for fixing or connecting the component to another component. .
  • ... unit when used, mean a unit capable of processing one or more functions or operations.
  • the present invention provides a method for analyzing the physiological phenomenon of an intractable bladder model by integrating a sensor capable of evaluating mechanical and electrical properties in a hydrogel with biocompatibility and adhesive properties, and Provides a system.
  • the material used as a bioimplantable sensor to analyze and control the physiological phenomenon of the bladder which was reported in Non-Patent Document 1, a prior art, is a silicone-based material (silicone rubber). These materials have a hydrophobic surface, and their mechanical properties (Young's modulus: several MPa ⁇ several GPa) are very different from those of living organs (a few Pa ⁇ several KPa), and have no functional groups that can attach to the surface of living organs, so they have adhesive properties. This has a bad drawback. Therefore, due to the disadvantage, an additional fixation system is required to attach the bio-implantable sensor, which can analyze physiological phenomena, to the surface of the organ.
  • the problem is that when using such a fixation system, it is easily peeled off from the biological surface and an air layer is formed, which reduces the reliability of the sensor signal, and has the disadvantage of requiring a new design of the fixation base for use in various organs.
  • the sensor according to the present invention includes a strain sensor that measures contraction and relaxation, and an EMG sensor that measures the bioelectricity of the nerve signal that causes detrusor muscle export. Therefore, a single sensor can measure both strain and EMG signals from the bladder by stably attaching to bladder tissue, thereby monitoring neural activity for more comprehensive and accurate urination detection.
  • Material preparation for the PAAm substrate consisted of 4.8 g of acrylamide (PAAm, Sigma-Aldrich), 0.0038 g of N,N'-methylenebisacrylamide (MBA, Sigma-Aldrich) as a curing agent, and 0.06 g of 2-Hydroxy-4 as a photoinitiator.
  • '-(2-Hydroxyethoxy)-2-methylpropiophenone) (Irgacure-2959 powder, Sigma-Aldrich) was synthesized in 10 mL of diluted water by ultrasound (UCP-10, JEIO TECH, 40 Hz). 100 ⁇ L of the as-synthesized PAAm solution was drop-cast on a carrier substrate (diced Si wafer, 10 mm x 15 mm), and then the coated PAAm solution was cured with ultraviolet (UV) light for 1 minute.
  • UV ultraviolet
  • EGaIn ink was prepared by mixing 0.3 mL of bulk eutectic gallium indium alloy (EGaIn(LM), Rich-Metals) and diluted acetic acid (3 vol% in 3 mL diluted water) in a vial, then sonicating the tip for 10 min at 500 W and 20 kHz. (VC 505, Sonics & Materials, 3mm microtip).
  • EGaIn(LM), Rich-Metals) diluted acetic acid (3 vol% in 3 mL diluted water
  • a nozzle printer (BIO X6, CELLINK) was used to coat the meniscus guide on the PAAm substrate.
  • the prepared EGaIn ink was put into a syringe used for direct nozzle printing, and the printing bed was heated to 60°C.
  • the tip diameter and printing speed of the nozzle were 200 ⁇ m and 6.4 mm/s, respectively.
  • an anisotropic conductive film was attached to an electrical pad made of EGaIn, and a PI conductive wire was then connected to the electrical pad.
  • a PAAm thin film was coated on the strain sensor and electrical pad areas through drop casting of 20 ⁇ L PAAm solution, and an anti-swelling layer was coated on the PAAm substrate, which is described in more detail below.
  • Coating an anti-swelling layer on a PAAm substrate involves mixing an acrylate-based material and an ultraviolet (UV) light-reactive primer in an organic solution.
  • a material having a polymerized unit derived from dodecyl acrylate was used, but any one polymerized unit selected from the group consisting of a polymerized unit derived from stearyl acrylate and a combination thereof was used. It can be included. That is, to diffuse the functional primer, which is HMPP (2-hydroxy-2-methylpropiophenone), onto the PAAm substrate, the PAAm substrate was soaked in the prepared primer solution for 10 minutes and then rinsed with ethanol and dilution water. Afterwards, UV light was applied to the PAAm substrate to form a thin anti-swelling layer on the PAAm substrate.
  • HMPP 2-hydroxy-2-methylpropiophenone
  • a Ferris wheel-shaped islet with a maximum output of 50W was patterned on polyimide film (PI, thickness: 50 ⁇ m) using a CO2 laser cutter (CE6000-60, GRAPHTEC). (See Figure 1 below). The maximum scan speed under ambient conditions was approximately 500 mm/s.
  • Ti/Au (10 nm/200 nm) was deposited on a Ferris wheel-shaped PI island substrate using an E-beam evaporator (SNTEK) with a custom metal magnetic mask.
  • the electrode deposited on the Ferris wheel-shaped island-shaped electrode consists of reference, recording, and ground electrodes, and also includes an electric pad for external connection. Afterwards, the counter, recording, and ground electrodes were coated with platinum black.
  • the radial Ferris wheel-shaped electrode sensor according to the present invention has excellent contractility and tensile properties, which will be described in more detail below.
  • Oxygen devices were formed on the bottom surface (side without electrodes) of the island of the above-described Ferris wheel-shaped EMG sensor by oxygen plasma treatment at 100 W for 1 minute. Afterwards, chemical vapor deposition (CVD) of a 10 vol% (2-Hydroxy-4'-(2-hydroxyethoxy)-2-methylpropiophenone) (Irgacure-2959, Sigma-Aldrich) solution in ethanol was used in a vacuum oven (OV3-30). , JEIO TECH) After conducting CVD for 1 hour at 60°C, the PAAm solution was applied to the island surface. Afterwards, UV light was applied for 5 minutes and an island-shaped EMG sensor was attached to the PAAm substrate.
  • CVD chemical vapor deposition
  • a hydrogel base was prepared by mixing 4.8 g of acrylamide, 0.712 g of CaCl (Sigma-Aldrich), 0.0248 g of ammonium persulfate (AMPS, Sigma-Aldrich), and 0.05 g of k-carrageenan (Sigma-Aldrich).
  • An adhesive was prepared.
  • FIG. 1 is a schematic diagram explaining a manufacturing method according to an embodiment of the present invention.
  • a linear strain sensor having a plurality of curved U-shaped bends and three electrodes formed on a Ferris wheel-shaped polyimide substrate with an island radiating radially from the central circular portion.
  • the EMG sensor composed of was simultaneously implemented on the hydrogel substrate (PAAm).
  • PAAm hydrogel substrate
  • a Ferris wheel-shaped island EMG sensor (Sensor) was used to ensure the mechanical stability of the sensor against repetitive contraction and expansion of the bladder during urination.
  • Figure 2 is a photograph after the sensor manufactured according to the present invention is attached to the bladder.
  • a Ferris wheel-shaped island EMG sensor (Sensor) and a line-shaped strain sensor (Sensor) having a plurality of curved parts are implemented simultaneously on one hydrogel substrate.
  • the Ferris wheel-shaped island EMG sensor was used to ensure the mechanical stability of the sensor against repetitive contraction and expansion of the bladder during urination.
  • the image below in Figure 2 is an image of the EMG sensor, showing three electrodes formed on an island-shaped polyimide substrate with a plurality of protruding radial structures.
  • Figure 3 is a block diagram of a sensing system according to the present invention.
  • the sensing system includes the sensor unit 100 of FIG. 2 attached to the bladder; and an analysis unit 200 that analyzes the signal received from the sensor.
  • the peak signal is filtered from the strain sensing signal, and then the urination time (urination point) is predicted from this. Additionally, the analysis unit 200 may calculate the root-mean-square deviation of the EMG sensing signal and then predict whether there is an overactive bladder. Therefore, in the present invention, two types of signals obtained from a sensor that can be attached to the bladder muscle itself rather than near the bladder can be used for predicting urination point, analyzing overactive bladder, etc.
  • Figure 4 is a diagram illustrating a sensing system and a sensing method manufactured according to an embodiment of the present invention.
  • the sensor manufactured according to an embodiment of the present invention is attached to the bladder on a hydrogel substrate and simultaneously senses EMG and strain, and integrates them to determine bladder phenomenon (urination point estimation). , overreactive bladder estimation can be analyzed in real time.
  • Figure 5 is a graph showing the relative volume change in PBS with and without an anti-swelling coating.
  • Figure 6 is strain-stress curves of PAAm with and without anti-swelling coating.
  • Figure 7 is a graph of adhesion when a conventional silicone rubber (Ecoflex-0020) is used as an adhesive on the same substrate (PAAm) and when a hydrogel-based adhesive is used.
  • a conventional silicone rubber (Ecoflex-0020) is used as an adhesive on the same substrate (PAAm) and when a hydrogel-based adhesive is used.
  • the PAAm substrate according to the present invention showed higher adhesive strength (260.86 N/m) than the existing silicone rubber substrate (2.15 N/m).
  • the widely used silicone rubber-based rubber material shows poor adhesion to the bladder even when adhesives are used. This is because silicone rubber-based rubber materials contain many methyl groups on the surface, so there is no chemical functional group that can form adhesion to the surface of the bladder and adhesive materials containing a lot of -OH groups, so the adhesion does not utilize adhesion.
  • the result is lower than the adhesive strength with the bladder of untreated PAAm.
  • the adhesive strength of PAAm with the bladder using the adhesive material according to the present invention is hundreds of times higher, which shows that stable adhesion can be maintained during the contraction and expansion of the bladder during urination.
  • the present invention enables the implementation of a system that can monitor the physiological phenomenon of the bladder in real time with an intractable model by integrating a sensor capable of evaluating mechanical and electrical properties in a hydrogel-based material.
  • a sensor capable of evaluating mechanical and electrical properties in a hydrogel-based material.
  • it uses an excellent adhesive for human tissues such as the bladder, it can be inserted into a pig's bladder and stably bonded without additional suture surgery through minimally invasive laparoscopic robotic surgery.
  • Figure 8 shows the results of testing the in vitro cytotoxicity of strain sensor and EMG sensor materials formed on a hydrogel substrate using HEK293 cells.
  • the sensor according to the present invention showed a level of in vitro cytotoxicity comparable to that of the control group (pure HEK293 cells cultured in a 48-well platter in (Dulbecco Modified Eagle Medium, DMEM)).
  • Figure 9 is an in-vivo protocol image of bladder contraction and expansion using a rat model
  • Figure 10 shows a strain sensor attached to the bladder by connecting a rubber tube to the rat bladder to induce a repetitive urination process through injection and discharge of liquid. and the sensing result of the EMG sensor.
  • FIG 11 shows the signal-to-noise ratio (SNR) compared to the existing EMG sensor by coating the EMG sensor of the sensor system according to the present invention with platinum black (PtB) to increase the overall cross-sectional area of the sensor. This is the result of improvement.
  • the EMG sensor coated with platinum black (PTB) according to an embodiment of the present invention showed an SNR of 22.84 dB, which is superior to the case without PTB coating.
  • Figure 14 shows the results of comparing and analyzing the results of Figure 13 in terms of the amount of urination per time and the time between urinations in the normal section and the overactive bladder induction section.
  • Figure 15 shows the results of tracking physiological indicators (urination volume, intravesical pressure) in the sensitive bladder induction section, and the exact timing of urination is indicated by a vertical dotted line.
  • Figure 16 shows the measurement results of the tension sensor and EMG sensor in the overactive bladder induction section.
  • Figure 17 shows the results of extracting data near the time of urination and taking the average based on the time of urination.
  • Figure 18 shows the results of quantitative analysis of the results of Figure 17.
  • Figure 19 is an image of the surgical protocol for implanting the hydrogel-based implantable sensor developed by our research team using a minimally invasive laparoscopic robotic implant surgical instrument.
  • Figure 20 is an image of the minimally invasive laparoscopic robot implantation surgery process using an actual pig
  • Figure 21 shows the surgical process in which the hydrogel-based implantable sensor developed by our research team is implanted and attached to the pig bladder using laparoscopic robot implantation surgery.
  • the image shown, Figure 22, is an image showing the pig's repetitive urination process and the results of the strain sensor and EMG sensor sensed during the urination process reflect the actual pig's urination process.
  • the senor attached using hydrogel a highly biocompatible material according to the present invention, is attached to the bladder surface muscle (detrusor muscle) instead of the muscle near the bladder due to its high adhesion and biocompatibility characteristics, and can be measured more directly. You can proceed.

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Abstract

L'invention concerne un système de détection de vessie en temps réel utilisant un élément sensible bio-implantable, le système de détection de vessie en temps réel comprenant : une unité de capteur qui est fixée à la vessie ; et une unité d'analyse qui analyse un signal reçu de l'unité de capteur.
PCT/KR2023/011978 2022-11-15 2023-08-11 Système de détection de vessie en temps réel par l'intermédiaire d'un élément de capteur bio-implantable WO2024106697A1 (fr)

Applications Claiming Priority (4)

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KR20220152858 2022-11-15
KR10-2022-0152858 2022-11-15
KR10-2023-0096402 2023-07-24
KR1020230096402A KR20240071300A (ko) 2022-11-15 2023-07-24 생체 삽입형 센서 소자를 통한 실시간 방광 센싱 시스템

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160100770A (ko) * 2015-02-16 2016-08-24 삼성전자주식회사 생체 정보를 측정하는 전자 장치 및 방법
US20160354028A1 (en) * 2015-04-29 2016-12-08 The Cleveland Clinic Foundation Bladder event detection for diagnosis of urinary incontinence or treatment of lower urinary tract dysfunction
KR20200080875A (ko) * 2018-12-27 2020-07-07 이승용 생체신호 측정장치
KR20200104827A (ko) * 2019-02-27 2020-09-04 서울대학교병원 하부요로 기능이상의 진단 시스템 및 방법
JP2022023525A (ja) * 2020-07-27 2022-02-08 株式会社ジェイテクト センサ、センサ付きデバイス、及びセンサの検査方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160100770A (ko) * 2015-02-16 2016-08-24 삼성전자주식회사 생체 정보를 측정하는 전자 장치 및 방법
US20160354028A1 (en) * 2015-04-29 2016-12-08 The Cleveland Clinic Foundation Bladder event detection for diagnosis of urinary incontinence or treatment of lower urinary tract dysfunction
KR20200080875A (ko) * 2018-12-27 2020-07-07 이승용 생체신호 측정장치
KR20200104827A (ko) * 2019-02-27 2020-09-04 서울대학교병원 하부요로 기능이상의 진단 시스템 및 방법
JP2022023525A (ja) * 2020-07-27 2022-02-08 株式会社ジェイテクト センサ、センサ付きデバイス、及びセンサの検査方法

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