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 PDFInfo
- 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
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tissue
- sensor
- oxygen
- sensing device
- vitality
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims description 52
- 238000012544 monitoring process Methods 0.000 title claims description 15
- 238000001356 surgical procedure Methods 0.000 title description 6
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims abstract description 63
- 229910052760 oxygen Inorganic materials 0.000 claims abstract description 63
- 239000001301 oxygen Substances 0.000 claims abstract description 63
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims abstract description 50
- 229910002092 carbon dioxide Inorganic materials 0.000 claims abstract description 25
- 239000001569 carbon dioxide Substances 0.000 claims abstract description 25
- 210000001072 colon Anatomy 0.000 claims abstract description 23
- 230000003872 anastomosis Effects 0.000 claims abstract description 22
- 102000001554 Hemoglobins Human genes 0.000 claims abstract description 10
- 108010054147 Hemoglobins Proteins 0.000 claims abstract description 10
- 238000012806 monitoring device Methods 0.000 claims description 19
- 230000010412 perfusion Effects 0.000 claims description 19
- 239000000463 material Substances 0.000 claims description 8
- 230000031700 light absorption Effects 0.000 claims description 6
- 229920000642 polymer Polymers 0.000 claims description 6
- 238000001514 detection method Methods 0.000 claims description 4
- 239000007789 gas Substances 0.000 claims description 4
- 210000001035 gastrointestinal tract Anatomy 0.000 claims description 3
- 210000001519 tissue Anatomy 0.000 claims 63
- 210000004400 mucous membrane Anatomy 0.000 claims 1
- 229960004424 carbon dioxide Drugs 0.000 abstract description 22
- 238000011477 surgical intervention Methods 0.000 abstract description 5
- 230000003094 perturbing effect Effects 0.000 abstract 1
- 238000005259 measurement Methods 0.000 description 28
- 238000010521 absorption reaction Methods 0.000 description 9
- 239000000017 hydrogel Substances 0.000 description 6
- 239000000523 sample Substances 0.000 description 6
- 230000035876 healing Effects 0.000 description 5
- 230000004044 response Effects 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 239000008280 blood Substances 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 4
- 230000008859 change Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 230000008961 swelling Effects 0.000 description 4
- 230000017531 blood circulation Effects 0.000 description 3
- 239000000975 dye Substances 0.000 description 3
- 239000004005 microsphere Substances 0.000 description 3
- 239000002861 polymer material Substances 0.000 description 3
- 238000002604 ultrasonography Methods 0.000 description 3
- 206010050456 Anastomotic leak Diseases 0.000 description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 230000004087 circulation Effects 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 239000002872 contrast media Substances 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 230000005672 electromagnetic field Effects 0.000 description 2
- 210000003743 erythrocyte Anatomy 0.000 description 2
- 210000003238 esophagus Anatomy 0.000 description 2
- 230000005284 excitation Effects 0.000 description 2
- 239000007850 fluorescent dye Substances 0.000 description 2
- 230000004907 flux Effects 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 238000003384 imaging method Methods 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 239000013307 optical fiber Substances 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 238000002600 positron emission tomography Methods 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 210000000664 rectum Anatomy 0.000 description 2
- 238000006722 reduction reaction Methods 0.000 description 2
- 238000002271 resection Methods 0.000 description 2
- 229910052709 silver Inorganic materials 0.000 description 2
- 239000004332 silver Substances 0.000 description 2
- 238000002603 single-photon emission computed tomography Methods 0.000 description 2
- 239000000758 substrate Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 230000000287 tissue oxygenation Effects 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 206010056519 Abdominal infection Diseases 0.000 description 1
- 206010006187 Breast cancer Diseases 0.000 description 1
- 208000026310 Breast neoplasm Diseases 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- 206010065879 Gastrointestinal anastomotic leak Diseases 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 241000699670 Mus sp. Species 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 206010047141 Vasodilatation Diseases 0.000 description 1
- 206010052428 Wound Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 238000012084 abdominal surgery Methods 0.000 description 1
- 238000000862 absorption spectrum Methods 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 238000002583 angiography Methods 0.000 description 1
- 210000000436 anus Anatomy 0.000 description 1
- 238000000149 argon plasma sintering Methods 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 235000013405 beer Nutrition 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 238000009530 blood pressure measurement Methods 0.000 description 1
- 238000009534 blood test Methods 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003638 chemical reducing agent Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000013170 computed tomography imaging Methods 0.000 description 1
- 239000004020 conductor Substances 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
- 239000010949 copper Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 238000003113 dilution method Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000002961 echo contrast media Substances 0.000 description 1
- 230000005281 excited state Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 231100001261 hazardous Toxicity 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000007954 hypoxia Effects 0.000 description 1
- 208000008384 ileus Diseases 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000012625 in-situ measurement Methods 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- 210000002429 large intestine Anatomy 0.000 description 1
- 231100000518 lethal Toxicity 0.000 description 1
- 230000001665 lethal effect Effects 0.000 description 1
- 230000008338 local blood flow Effects 0.000 description 1
- 238000009607 mammography Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000004377 microelectronic Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000013421 nuclear magnetic resonance imaging Methods 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 238000006213 oxygenation reaction Methods 0.000 description 1
- 238000001139 pH measurement Methods 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 230000010363 phase shift Effects 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000010791 quenching Methods 0.000 description 1
- 230000000171 quenching effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000004895 regional blood flow Effects 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 239000004065 semiconductor Substances 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 238000012285 ultrasound imaging Methods 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements 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
- A61B5/6879—Means for maintaining contact with the body
- A61B5/6882—Anchoring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/07—Endoradiosondes
- A61B5/076—Permanent implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring 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
- A61B5/1455—Measuring 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
- A61B5/1459—Measuring 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
- A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/02—Operational features
- A61B2560/0204—Operational features of power management
- A61B2560/0214—Operational features of power management of power generation or supply
- A61B2560/0219—Operational features of power management of power generation or supply of externally powered implanted units
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/028—Microscale sensors, e.g. electromechanical sensors [MEMS]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring 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
- A61B5/1455—Measuring 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
- A61B5/14551—Measuring 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
- A61B5/14556—Measuring 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.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Animal Behavior & Ethology (AREA)
- Pathology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Endocrinology (AREA)
- Gastroenterology & Hepatology (AREA)
- Physiology (AREA)
- Spectroscopy & Molecular Physics (AREA)
- Optics & Photonics (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
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.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/NL2005/000508 WO2007008057A1 (fr) | 2005-07-14 | 2005-07-14 | Système et procédé de surveillance de la vitalité d'un tissu, et technique chirurgicale |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/NL2005/000508 WO2007008057A1 (fr) | 2005-07-14 | 2005-07-14 | Système et procédé de surveillance de la vitalité d'un tissu, et technique chirurgicale |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2007008057A1 true WO2007008057A1 (fr) | 2007-01-18 |
Family
ID=35965939
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/NL2005/000508 WO2007008057A1 (fr) | 2005-07-14 | 2005-07-14 | Système et procédé de surveillance de la vitalité d'un tissu, et technique chirurgicale |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2007008057A1 (fr) |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
US11344731B2 (en) | 2012-05-29 | 2022-05-31 | Autonomix Medical, Inc. | Endoscopic sympathectomy systems and methods |
US11877833B2 (en) | 2019-07-26 | 2024-01-23 | Covidien Lp | Systems and methods for monitoring blood pressure with a powered linear drive |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5833603A (en) * | 1996-03-13 | 1998-11-10 | Lipomatrix, Inc. | Implantable biosensing transponder |
WO2001000783A2 (fr) * | 1999-06-25 | 2001-01-04 | Advanced Tissue Sciences, Inc. | Echafaudages tridimensionnels surveillables et systemes de cultures cellulaires |
WO2001097687A1 (fr) * | 2000-06-20 | 2001-12-27 | Chf Solutions, Inc. | Stent instrumente |
US20040133079A1 (en) * | 2003-01-02 | 2004-07-08 | Mazar Scott Thomas | System and method for predicting patient health within a patient management system |
WO2005015173A1 (fr) * | 2003-06-17 | 2005-02-17 | Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno | Capteurs comprenant des composants en polymere |
-
2005
- 2005-07-14 WO PCT/NL2005/000508 patent/WO2007008057A1/fr active Application Filing
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5833603A (en) * | 1996-03-13 | 1998-11-10 | Lipomatrix, Inc. | Implantable biosensing transponder |
WO2001000783A2 (fr) * | 1999-06-25 | 2001-01-04 | Advanced Tissue Sciences, Inc. | Echafaudages tridimensionnels surveillables et systemes de cultures cellulaires |
WO2001097687A1 (fr) * | 2000-06-20 | 2001-12-27 | Chf Solutions, Inc. | Stent instrumente |
US20040133079A1 (en) * | 2003-01-02 | 2004-07-08 | Mazar Scott Thomas | System and method for predicting patient health within a patient management system |
WO2005015173A1 (fr) * | 2003-06-17 | 2005-02-17 | Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno | Capteurs comprenant des composants en polymere |
Cited By (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8118206B2 (en) | 2008-03-15 | 2012-02-21 | Surgisense Corporation | Sensing adjunct for surgical staplers |
EP2608712A4 (fr) * | 2010-08-23 | 2017-12-27 | Landy Aaron Toth | Système et procédé de surveillance d'un site chirurgical |
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 |
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 |
WO2013162611A1 (fr) * | 2012-04-27 | 2013-10-31 | Empire Technology Development, Llc | Détection de fuite gazeuse dans un corps pour détection précoce de fuite anastomotique colorectale |
US9295409B2 (en) | 2012-04-27 | 2016-03-29 | Empire Technology Development Llc | Sensing of gaseous leakage into body for early detection of colorectal anastomotic leakage |
US12053634B2 (en) | 2012-05-29 | 2024-08-06 | Autonomix Medical, Inc. | Endoscopic sympathectomy systems and methods |
US11344731B2 (en) | 2012-05-29 | 2022-05-31 | Autonomix Medical, Inc. | Endoscopic sympathectomy systems and methods |
DE102014117879A1 (de) * | 2014-12-04 | 2016-06-09 | Osram Opto Semiconductors Gmbh | Pulsoxymetrie-Vorrichtung und Verfahren zum Betreiben einer Pulsoxymetrie-Vorrichtung |
US10485465B2 (en) | 2014-12-04 | 2019-11-26 | Osram Opto Semiconductors Gmbh | Pulse oximetry device and method of operating a pulse oximetry device |
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 |
US11253257B2 (en) | 2017-03-08 | 2022-02-22 | Covidien Lp | Surgical instruments including sensors |
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 |
US11877833B2 (en) | 2019-07-26 | 2024-01-23 | Covidien Lp | Systems and methods for monitoring blood pressure with a powered linear drive |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US7813778B2 (en) | Implantable tissue ischemia sensor | |
US8133177B2 (en) | System and method for assessing capillary vitality | |
US7313424B2 (en) | Diagnosis of body metabolic emergency state | |
Mourant et al. | Elastic scattering spectroscopy as a diagnostic tool for differentiating pathologies in the gastrointestinal tract: preliminary testing | |
US7322971B2 (en) | Surgical drain with sensors for monitoring internal tissue condition by transmittance | |
US9044179B2 (en) | Oxygen sensor for internal monitoring of tissue oxygen in vivo | |
JP5981142B2 (ja) | 出血検出のためのデバイスおよびシステム | |
JP3151669B2 (ja) | 標的のpHを測定する装置、該装置の使用方法及びその用途 | |
US20070038126A1 (en) | System and method for monitoring of end organ oxygenation by measurement of in vivo cellular energy status | |
US20050065436A1 (en) | Rapid and non-invasive optical detection of internal bleeding | |
US20080188727A1 (en) | Broadband solid-state spectroscopy illuminator and method | |
JP2009512500A (ja) | 体内腫瘍のスクリーニングのための超高特定性装置及び方法 | |
Mignani et al. | In-vivo biomedical monitoring by fiber-optic systems | |
US12232870B2 (en) | Systems and methods of optical transcutaneous oxygenation monitoring | |
US10925528B2 (en) | Depth scanning oxygen sensor | |
WO2007008057A1 (fr) | Système et procédé de surveillance de la vitalité d'un tissu, et technique chirurgicale | |
Baldini et al. | Optical-fiber medical sensors | |
US20250160701A1 (en) | Systems And Methods Of Optical Transcutaneous Oxygenation Monitoring | |
Baldini et al. | In-vivo biomedical monitoring by fiber optic systems | |
Thompson | Biomedical fiber optic sensors: Problems and prospects | |
WO2003011130A2 (fr) | Methode de detection du cancer par agent d'accentuation thermique et surveillance thermique non infractive |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application | ||
NENP | Non-entry into the national phase |
Ref country code: DE |
|
122 | Ep: pct application non-entry in european phase |
Ref document number: 05759898 Country of ref document: EP Kind code of ref document: A1 |