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WO2007008057A1 - Système et procédé de surveillance de la vitalité d'un tissu, et technique chirurgicale - Google Patents

Système et procédé de surveillance de la vitalité d'un tissu, et technique chirurgicale Download PDF

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Publication number
WO2007008057A1
WO2007008057A1 PCT/NL2005/000508 NL2005000508W WO2007008057A1 WO 2007008057 A1 WO2007008057 A1 WO 2007008057A1 NL 2005000508 W NL2005000508 W NL 2005000508W WO 2007008057 A1 WO2007008057 A1 WO 2007008057A1
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WO
WIPO (PCT)
Prior art keywords
tissue
sensor
oxygen
sensing device
vitality
Prior art date
Application number
PCT/NL2005/000508
Other languages
English (en)
Inventor
P.J. French
J. Jeekel
J. F. Lange
Original Assignee
Erasmus University Medical Center Rotterdam
Technische Universiteit Delft
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Erasmus University Medical Center Rotterdam, Technische Universiteit Delft filed Critical Erasmus University Medical Center Rotterdam
Priority to PCT/NL2005/000508 priority Critical patent/WO2007008057A1/fr
Publication of WO2007008057A1 publication Critical patent/WO2007008057A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879Means for maintaining contact with the body
    • A61B5/6882Anchoring means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/07Endoradiosondes
    • A61B5/076Permanent implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/42Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0204Operational features of power management
    • A61B2560/0214Operational features of power management of power generation or supply
    • A61B2560/0219Operational features of power management of power generation or supply of externally powered implanted units
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/028Microscale sensors, e.g. electromechanical sensors [MEMS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14556Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases by fluorescence

Definitions

  • the invention relates to a tissue vitality monitoring system and method.
  • Anastomosis is the surgical joining of parts of the bowel or of other organs to make them continuous and is an ongoing problem, showing a high morbidity and mortality and involving tremendous costs.
  • 3-12% of all gastrointestinal anastomoses leak, with the highest occurrences for leakage being observed for rectum resection (10%), pancreas surgery (8%) and esophagus resection (5%).
  • One example of a technique to detect leakage of an anastomosis is to fill the abdomen with a saline solution, while the colon is immersed in it. If air bubbles develop at the anastomotic site there is clear indication that the anastomosis is leaking. Unfortunately, such an examination is time consuming and not very accurate. Moreover, it does not offer the certainty that the anastomosis will not leak at a later stage.
  • To detect subsequent leakage of an anastomosis patients are surveyed by evaluating clinical, radiological and endoscopic parameters with limited sensitivity such as pain, fever, ileus, CT imaging, urine production (volume) and blood tests.
  • a common shortcoming of the above methods is the use of invasive probes that have to be used to heat and acquire temperature information.
  • a noninvasive method to measure tissue perfusion using the phase shift between an applied sinusoidal heat flux and the skin surface temperature response has been proposed in J. Liu, Y. Zhou, Z. Deng, "Sinusoidal heating method to no invasively measure tissue perfusion", IEEE Transactions on Biomedical Engineering, vol. 49, no.8, 2002, pp. 867-877.
  • the induced thermal field needs to be weak enough so that it does not affect the regional blood flow.
  • the heat flux was generated with a heat plate consisting of copper wires, while the surface temperature response was measured with a thermocouple.
  • tissue perfusion is investigated using the PET (positron emission tomography) and SPECT (single photon emission computed tomography) techniques, but these are very costly and cannot be used to provide continuous measurements for anastomotic leakage.
  • PET positron emission tomography
  • SPECT single photon emission computed tomography
  • Other imaging techniques such as angiography or nuclear magnetic resonance imaging are invasive and use expensive equipment.
  • Laser Doppler flowmeter A less costly device, used in different hospitals, is the Laser Doppler flowmeter.
  • the device is employed for the real-time measurement of microvascular blood flow.
  • Laser Doppler Flowmetry works by illuminating the tissue under observation with low -power laser light from a probe containing optical fibre light guides. Laser light from one fibre is scattered within the tissue and some is scattered back to the probe. Another optical fibre collects the backscattered light from the tissue and returns it to a monitor. Most of the light is scattered by tissue that is not moving but a small percentage of the returned light is scattered by moving red blood cells. The light returned to the monitor undergoes signal processing whereby the emitted and returned signals are compared to extract the Doppler shift related to moving red blood cells.
  • LDF Laser Doppler Flowmetry
  • US patent No. 6,241,743 discloses application of an oxygen sensor in an implanted anastomosing ring for veins.
  • this ring contains a sensor for measuring oxygen content of blood that flows through the anastomosed artery.
  • WO02060244 discloses the implantation into mice of temperature sensors from which data can be read with a wireless transponder. These sensors are not directed at anastomosed tissue.
  • Clark polarographic or amperometric
  • the anode is commonly made of silver.
  • the current flow from the anode to the cathode is proportional to the oxygen content of the solution.
  • Miniature silicon-based Clark cells have been developed making them suitable for use in tissue measurements, where they are affixed to the skin of human subjects.
  • Polarographic electrodes have been widely used for monitoring tissue oxygen but a number of disadvantages remain unresolved. At low oxygen pressures, the electrodes consume a significant quantity of oxygen by the electro-chemical reduction reaction.
  • capillary oxygen pressure may approximate arterial oxygen pressure in areas of the skin where local blood flow exceeds the amount necessary for local tissue oxygen needs. This approximation may hold if the local area is heated.
  • An electrode is attached to tissue and heated to 4O 0 C, providing local vasodilatation. Oxygen from the capillaries can then diffuse through the skin into a Clark cell, for direct measurement.
  • the disadvantages of this technique are the tissue burns that result from a prolonged application for more than 2-3 hours.
  • tissue vitality monitoring system that aids the surgeon during the operation to reduce the number of complications requiring a second operation (construction of an artificial anus/stoma) and/or, in cases where there are still complications, to give a fast warning so that the problem can be tackled quickly to save the patient or prevent irreparable damage.
  • a surgical method that includes anastomosis of tissue and attachment of a wireless sensing device.
  • the sensitive surface of the sensing device is placed facing the anastomosed tissue.
  • the sensing device includes a wireless transponder circuit, preferably an RF transponder circuit that derives its power supply from the RF field from outside.
  • a wireless transponder circuit preferably an RF transponder circuit that derives its power supply from the RF field from outside.
  • Such devices are known per se for example from access control systems, wherein a transponder is provided on a card that is carried by authorized persons.
  • Commercial applications of this technique to medical are available from Telemedtronic, and described in WO02060244.
  • sensing data is read from the sensing device with a transmitting/receiving unit to monitor tissue vitality of the anastomosed tissue.
  • the method is applied to anastomosis of the colon and the sensing device is attached to colon tissue in the intestinal tract and the sensing device is affixed to the colon only by a soluble attachment such as a soluble suturing wire.
  • a soluble attachment such as a soluble suturing wire.
  • the sensing device will be washed out after a few days without further need for an intervention to remove the device.
  • the method can be applied to any kind of tissue, in particular to wounds to monitor healing.
  • a method of monitoring parameters of tissue vitality comprising using a transmitter/receiver to read sensor output data from wireless transponder of a sensing device that is attached to the tissue with a most sensitive surface facing the tissue.
  • the sensing device is arranged to sense oxygen and/or carbon- dioxide perfusion in the tissue.
  • a high level of oxygen is indicative of healthy blood circulation.
  • Accumulation of carbon-dioxide is indicative of the absence of healthy blood circulation.
  • the sensing device senses the pressure of oxygen and/or carbon dioxide that diffuses from the tissue into part of the sensing device through the sensitive surface.
  • the sensor senses absorption of light that returns to the sensing device through the sensitive surface from the tissue adjacent the sensitive surface.
  • a plurality of measurements for different wavelength bands is used to determine the fraction of hemoglobin that is oxygenated.
  • a plurality of sensors for different parameters is integrated together in the vitality-monitoring device.
  • a sensing device is used in the manufacture of a tissue vitality monitoring device and preferably for an anastomosed tissue vitality monitoring device, and more preferable for an anastomosed colon tissue vitality monitoring device.
  • Figure 1 shows a tissue vitality monitoring system
  • Figure 2-4 show sensing devices
  • FIG. 1 shows a tissue vitality monitoring system (not drawn to scale) comprising a transmitter/receiver unit 10, and a wireless sensing device 12 attached to tissue 14.
  • Sensing device 12 comprises a wireless transponder circuit 120, an interface circuit 121 and sensors 122, 124, 126, 128. Sensors 122, 124, 126, 128 each have an exposed surface through which they sense tissue parameters. These sensitive surfaces all lie on a sensing surface 129 of sensing device 12 (typically in a single plane).
  • Interface circuit 121 couples sensors 122, 124, 126, 128 to transponder circuit 120.
  • Sensing device 12 has attached rings 16 (shown in side view) in a plane that is parallel to sensing surface 129 and/or lies in an extension of sensing surface 129. Rings 16 have eyes of a size to receive suturing wires that attach sensing device 12 to tissue 14 (e.g. a diameter of between 1 and 5 millimetre). In the attached position sensing surface 129 faces tissue 14 and is in contact with tissue 14. Rings may be provided for example on a backplate on which one or more semi-conductor devices are mounted that implement transponder circuit 120, interface circuit 121 and sensors 122, 124, 126, 128.
  • tissue vitality monitoring system is during or in the aftermath of colon surgery.
  • a part of the colon of a patient is removed and the ends of colon on either side of the removed part are joined to each other (anastomosed) using suturing wire or staples for example.
  • Sensing device 12 is attached to the colon in the digestive tract (on the inside of the colon), with sensing surface 129 facing the anastomosed tissue (facing anastomosed tissue, as used herein, means facing tissue right at the point of anastomosis or so close to this point that the vitality of the tissue that is in contact with sensing surface 129 is decisive for leakage from the anastomosis).
  • sensing data is read at least once from sensing device 12, using transmitter/receiver unit 10. Typically this is done a number of times during recuperation from the surgical intervention, or even before the time of completion of the surgical intervention.
  • the resulting measurement data is provided to a doctor for analysis and decision whether a renewed intervention or treatment is necessary due to lack of vitality of the tissue.
  • conventional soluble suturing wire, soluble staples or any other soluble attachment means are provided through rings 16 and through the wall of the colon.
  • the biocompatibility tests are less stringent than for permanent implants.
  • the sensing device 12 can be fixed on the outside of the colon, as a permanent implant, or on the outside of the colon and attached to a drain.
  • Transmitter/receiver unit 10 and wireless transponder circuit 120 may be implemented using known techniques.
  • transmitter/receiver unit 10 is designed to emit an electromagnetic field that carries a query signal.
  • transponder circuit 120 is arranged to pick up energy from the field (or from an auxiliary field emitted by transmitter/receiver unit 10) and to power operation of sensing device from the picked up energy.
  • Transponder circuit 120 is arranged to receive and decode the query signal and to generate a response signal (e.g. in the form of a modulation of absorption of the electromagnetic field) that encodes sensor output data requested by the query signal.
  • Transmitter/receiver unit 10 detects the response signal and decodes the sensor output data from the response signal.
  • the sensor output data may then be displayed by transmitter/receiver unit 10, or uploaded to a diagnostic system (not shown) and/or processed to provide more convenient data.
  • Sensors 122, 124, 126, 128 are designed to measure tissue parameters that are indicative of tissue vitality. Any type or combination of sensors suitable for this purpose may be used. Preferably sensors for in situ measurements of the quality of the arterial and venous circulation (perfusion) in the anastomosed tissue are used.
  • An example of a parameter that may be sensed as an indication of perfusion is oxygen pressure in the tissue, for example in terms of oxygen pressure of oxygen that diffuses from the tissue through the sensitive surface into part of the sensor body.
  • Another example of a parameter that may be sensed as an indication of perfusion is oxygen saturation, i.e. the quantity of oxygen in the tissue, or more preferably the fraction of hemoglobin in the tissue adjacent sensing surface 129 that is oxygenated.
  • Another example of a parameter that may be sensed as an indication of perfusion is carbon dioxide partial pressure in the tissue.
  • an oxygen pressure sensor 122 an oxygen saturation sensor 124, a carbon-dioxide pressure sensor 126 and a temperature sensor 128 are used.
  • oxygen pressure sensor 122, oxygen saturation sensor 124, and carbon-dioxide pressure sensor 126 each have an exposed surface next to, or through, which these sensors sense oxygen and/or carbon dioxide. These sensitive surfaces all lie on a sensing surface 129 of sensing device 12 (typically in a single plane).
  • FIG. 2 shows an illustrative example of an oxygen and carbon dioxide sensor 20 in the sensing device.
  • Sensor 20 comprises a substrate 22 with a first and second photodiode 24a,b thereon. Respective layers of polymer material 26a,b are provided on photodiodes 24a,b. Between photodiodes 24a,b a well is provided. The well has skewed sidewalls 28a,b covered by reflective material. A LED 29 (Light Emitting Diode) is provided in well 25, positioned to emit light on either side of LED 29 towards skewed sidewalls 28a,b.
  • the layers of polymer material 26a,b extend from above photodiodes 24a,b at least to the emitting sides of LED 29. LED 29 and photodiodes 24a,b have anode and diode contacts (not shown) coupled to interface circuit 121 (not shown).
  • Each layer 26a,b comprises a gas permeable polymer and a fluorescent compound that is immobilized in the gas permeable polymer.
  • fluorescent compounds are used of which the dye will be quenched by contact with oxygen and carbon dioxide respectively.
  • the dye in the polymer of a first one of the layers 26a is reactive to oxygen but not, or less, permeable for carbon dioxide.
  • the dye in the polymer of the second one of the layers 26b is carbon-dioxide reactive but not, or less, reactive for oxygen.
  • Materials of this type are described in Draaijer A., Konig J. W., Gans de O. Jetten J., Douma A.C. "A novel optical method to determine oxygen in beer bottles", 27th Congress of the European Brewery Convention 1999
  • the surfaces of layers 26a,b form the sensitive surface of the sensor.
  • the main (largest) surfaces of layers 26a,b are placed into contact with tissue 14.
  • oxygen and carbondioxide will diffuse from the tissue into layers 26a,b, establishing a concentration that depends on the pressure of free oxygen/carbon-dioxide in tissue 14.
  • tissue will fold around the top and sides of layers 26a,b and against a remainder of surface 129 around layers 26a,b so that substantially no oxygen or carbon dioxide from other sources can diffuse into layers 26a,b.
  • layers 26a,b may be provided in a recess of sensitive surface 129 to seal off diffusion from outside.
  • During measurement interface 121 applies a voltage pulse between the anode and cathode of LED 29 to cause emission of a pulse of light with a wavelength of about 470 nm for example, which is reflected into layers 26a,b via skewed sidewalls 28a,b.
  • the pulse excites the fluorescent molecules in layers 26a,b.
  • the fluorescent molecules decay to their unexcited state, emitting fluorescent light.
  • the excited state (caused by an excitation light pulse) of a fluorescent molecule is deactivated by a collision process with oxygen, which has the effect that the fluorescence decreases.
  • the fluorescence decay time depends on the concentration of oxygen and carbon dioxide that has diffused into layers 26ab respectively.
  • Measurement interface 121 measures the conductivity of photodiodes 24a,b to measure the intensity of the fluorescence from layers 26a,b as a function of time.
  • the oxygen concentration in such sensors can be determined in two ways: by measuring the fluorescence intensity or by measuring the fluorescence lifetime. Using the latter method has the advantage that the measurement is independent of the source intensity, detector efficiency and fluorescent probe concentration.
  • Measurement interface 121 sends data indicative of the measured intensities or a decay time that it has computed from the intensities to transmitter/receiver unit 10 via transponder circuit 120.
  • the sensor system can be miniaturised to the dimensions required by in situ monitoring of anastomoses.
  • the size of the sensor is made so small that it does not significantly interfere or jeopardize functioning of the anastomosed tissue.
  • the diameter of the sensor is less than one centimetre, more preferably less than half a centimetre or even less than a millimetre. It is important to note that the quenching process does not consume oxygen or carbon dioxide, so that the measurements can easily be repeated over an extended period of time.
  • simple LED excitation and photodiode detection can be used to construct a simple oxygen sensor.
  • the sensor of figure 2 can be manufactured using conventional photolithographic micro-electronics manufacturing techniques, followed by the application of layers 26a,b. Alternatively, the LEDS and/or any other parts may be manufactured separately and placed in the sensor.
  • FIG. 3 shows an alternative Carbon-dioxide pressure sensor 30.
  • This type of sensor is known per se from an article titled "A swelling hydrogel- based PCO2 sensor", by S. Herber, W.Olthuis and P. Bergveld and published in Sensors and Actuators B 91 (2003) pages 378-382.
  • This sensor comprises a cavity 34 filled with a bicarbonate solution.
  • a top of cavity 34 is closed off with a carbon-dioxide permeable membrane 36.
  • a porous metal screen 35 is provided in cavity 34, attached to substrate 22 on opposite sides of cavity 34.
  • a hydrogel 32 provided between a bottom of cavity 34 and screen 35. that is filled with a bicarbonate solution next to hydrogel 32.
  • Hydrogel 32 contains microspheres that respond to changes in pH by swelling or shrinking, dependent on the direction of change in pH.
  • a strain gauge 38 is attached to the bottom of the cavity.
  • Hydrogel 32 contains microspheres that respond to changes in pH by swelling or shrinking, dependent on the direction of change in pH.
  • a carbon dioxide pressure balance is established between the tissue and the solution.
  • Changes in the carbondioxide in the hydrogel changes the pH of the solution, which results in swelling or shrinking of the microspheres. In turn this results in a change in the force that the hydrogel exerts on the bottom of the cavity.
  • a resulting deformation is measured by strain gauge 38.
  • Figure 4 shows an oxygen saturation sensor 40 which is designed to measure differences in the light absorption spectrum of deoxygenated and oxygenated hemoglobin. The construction of sensor 40 is similar to that of figure 2, with LEDs 44a,b and photodiodes 46.
  • photodiodes 46 are realized using vertically stacked p-n junctions each optimised for a different wavelength or wavelength band.
  • Oxygenated blood has a rich red colour whereas when the oxygen saturation level is low, the colour is darker.
  • the oxygen saturation level can be determined by measuring the absorption at two wavelengths, 800 nm and 660 nm. The change in absorption is most obvious for light of wavelengths of 660 nm. At 800 nm the absorption is the same for both oxygenated and deoxygenated blood and this can be used as a reference level for the measurements.
  • the sensor measures light scattering and absorption of light from LED's 44a,b in the tissue at a plurality of wavelengths. Thus absorption due to hemoglobin with and without oxygenation is determined.
  • interface circuit 121 causes LEDs 44a,b to emit light in different wavelength bands and senses the output current or voltage of photodiodes 46 to measure the intensity of the scattered light from the tissue.
  • Transponder circuit 120 returns the measurement results, or data obtained by interface circuit 121 after processing the measurement results, to transmitter/receiver unit 10. From the two measurements the oxygen saturation can be obtained.
  • Preferably interface circuit 121 measures the output current or voltage of the photodiodes to detect the light as part of absorption and/or for quantitative pressure measurements.
  • some form of threshold light intensity detection may be used, optionally combined with controlled variation of the emission intensity of the LEDs, to measure absorption for example.
  • threshold detection may be used to measure decay times.
  • each of the illustrated sensors can be realized on the same type of sensor surface, using similar manufacturing techniques. This makes it possible to integrate a plurality of different sensors on a miniaturized device that can be introduced into the colon and washed out of the colon without additional problems for the patient.
  • the sensor device for colon tissue oxygenation preferably includes an oxygen saturation (SO2) sensor, an oxygen pressure (PO2) sensor, a carbon- dioxide pressure (PCO2) sensor.
  • a temperature sensor is preferable integrated as well. The measurement of temperature can be used as an indicator of local infection.
  • a pH sensor may be integrated as well. The measurement of pH can be used as an indicator of tissue condition.
  • Transponder circuit 120 and interface circuit 121 may be integrated on the same chip with the sensors, but preferably they are integrated on a separate chip or chips, that may be mounted against the back of the chip on which the sensors are integrated (i.e. on a face opposite sensitive surface 129).
  • a simplified device may be used wherein one or more of the sensors have been omitted. The remaining sensors may provide sufficient information to monitor vitality of the tissue.
  • rings are provided to attach the sensing device to the anastomosed tissue
  • alternative means for attachment are possible.
  • the sensing device could be provided attached to a piece of soluble suture, so that it can be attached to the tissue by suturing.
  • the sensing device could be provided attached to a soluble suturing staple, so that it can be attached to the tissue by stapling.
  • the size of the sensor is made so small that it does not significantly interfere or jeopardize functioning of the anastomosed tissue.
  • the diameter of the sensor is less than one centimetre, more preferably less than half a centimetre or even less than a millimetre.
  • the measurement results may be compared with reference data for vital and/or non-vital tissue, to produce a forecast the start of the healing process.
  • a novel transponder there is no need for a battery to power the sensor system and the data can be transmitted wireless to the outside of the patients' body. These sensors will remain at the anastomotic site in order to monitor the healing process for 4-7 days.

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Abstract

Selon la présente invention, la vitalité d'un tissu est surveillée au moyen d'un capteur fixé au tissu. De préférence, le capteur est fixé au tissu à la fin d’une intervention chirurgicale, par exemple après une anastomose du côlon. Le capteur est fixé au tissu, une surface sensible faisant face au tissu, par exemple au niveau d'un point d'anastomose. Le capteur est conçu pour mesurer par exemple une pression de dioxyde de carbone ou d'oxygène (partielle) du tissu, ou la quantité d'hémoglobine oxygénée du tissu. Le capteur est intégré dans un dispositif de détection avec un circuit de transpondeur sans fil pour lire les données de sortie du capteur à partir d'un circuit de transpondeur sans fil. Il en résulte que le capteur peut par la suite être utilisé pour extraire l'information concernant la vitalité du tissu, même si le capteur lui-même est situé dans un endroit inaccessible, notamment à l'intérieur du côlon, sans perturber physiquement le tissu.
PCT/NL2005/000508 2005-07-14 2005-07-14 Système et procédé de surveillance de la vitalité d'un tissu, et technique chirurgicale WO2007008057A1 (fr)

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US8118206B2 (en) 2008-03-15 2012-02-21 Surgisense Corporation Sensing adjunct for surgical staplers
US20130289367A1 (en) * 2012-04-27 2013-10-31 Empire Technology Development, Llc Sensing of gaseous leakage into body for early detection of colorectal anastomotic leakage
DE102014117879A1 (de) * 2014-12-04 2016-06-09 Osram Opto Semiconductors Gmbh Pulsoxymetrie-Vorrichtung und Verfahren zum Betreiben einer Pulsoxymetrie-Vorrichtung
EP2608712A4 (fr) * 2010-08-23 2017-12-27 Landy Aaron Toth Système et procédé de surveillance d'un site chirurgical
US10624616B2 (en) 2015-12-18 2020-04-21 Covidien Lp Surgical instruments including sensors
US10638944B2 (en) 2017-02-22 2020-05-05 Covidien Lp Methods of determining tissue viability
US10687811B2 (en) 2017-03-08 2020-06-23 Covidien Lp Surgical instruments including sensors
US10945616B2 (en) 2017-05-12 2021-03-16 Covidien Lp Blood pressure measuring surgical instrument
US11241192B2 (en) 2011-07-04 2022-02-08 Veenhof Medical Devices B.V. System and method for predicting the viability of a body tissue in a patient, and measuring device used therein
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