WO2009090293A1 - Sonde endoscopique à capteur opto-électronique à usage diagnostique et chirurgical - Google Patents

Sonde endoscopique à capteur opto-électronique à usage diagnostique et chirurgical Download PDF

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Publication number
WO2009090293A1
WO2009090293A1 PCT/ES2009/070004 ES2009070004W WO2009090293A1 WO 2009090293 A1 WO2009090293 A1 WO 2009090293A1 ES 2009070004 W ES2009070004 W ES 2009070004W WO 2009090293 A1 WO2009090293 A1 WO 2009090293A1
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WIPO (PCT)
Prior art keywords
probe
elements
sensor
emitting
sensors
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PCT/ES2009/070004
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English (en)
Spanish (es)
Inventor
María Luisa DOTOR CASTILLA
Juan Pedro Silveira Martin
Sonnia María LOPEZ SILVA
Luis Antonio HERRERA NOREÑA
Romano Giannetti
Original Assignee
Consejo Superior De Investigaciones Cientificas
Hospital Universitario Marques De Valdecilla
Universidad Pontificia Comillas
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Publication of WO2009090293A1 publication Critical patent/WO2009090293A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for

Definitions

  • the invention finds application in the field of diagnosis and surgery, in particular endoscopy, interventional radiology and laparoscopic surgery, both endoscopic and endocavitary, and especially in human clinics, without excluding veterinary medicine, and especially in situations in which It requires the evaluation of intracorporeal organs and tissues in a non-invasive manner, such as those that occur in the fields of conventional surgery, emergency and organ transplants, as well as in the care of patients in critical situations (ICU, ICU , postoperated units, etc).
  • endoscopy and video surgery (or minimally invasive surgery) is considered by many to be the third revolution in surgery, after anesthesia and the application of antibiotics. Surgeons perform this type of surgery in almost any space and in any organ of the human body, using highly complex cameras and video monitors associated with surgical instruments.
  • the technique consists in carrying out the appropriate approach to each need, introducing a gas (usually carbon dioxide), to create, with its expansion, a working cavity. Through other small cuts and additional incisions, sometimes in combination with natural holes (for example, the mouth or the vagina), a telescopic instrument is inserted attached to a video camera or optical viewfinder (laparoscope when working on the abdomen ) and other long and narrow surgical instruments.
  • one of the main disadvantages is that the surgeon loses important sensory information, since: a) he must pass from his real three-dimensional vision of the operative field to the two-dimensional one through a flat monitor where the images obtained by the camera are shown endoscopic This implies that even bright surgeons in open surgery must perform special training to transfer their surgical skills to endoscopic surgery, an adaptation that requires a lot of practice; b) the perception of colors is not real; c) you cannot use touch to capture certain sensations, such as textures, weak palpitations, etc. Therefore, the measurement of physiological parameters that help them to overcome these deficiencies would be particularly useful. In this sense, in open and endoscopic surgery, as well as in hospital care, invasive and non-invasive techniques are used to obtain this information.
  • electrocardiography capnometry
  • capnography measurement of this carbon dioxide as a function of time
  • volumetric analysis are widely used.
  • ventilatory pressures ultrasound (in which images of the internal organs are formed by external application of ultrasound and analysis of the reflected ones), etc.
  • Photoplethysmography and pulse oximetry have been developed in particular, techniques commonly used to monitor the heart rate and the degree of oxygenation in the blood in a non-invasive manner.
  • Photoplethysmography is a technique based on the application of optical radiation to an organ or tissue, originating, after its interaction with the latter, a signal proportional to changes in blood volume, so it is a simple and useful method to measure The pulsatile component of the heartbeat and evaluate the blood circulation.
  • the degree of oxygenation is determined by measuring the optical radiation reflected or transmitted by the analyzed organ in two or more wavelengths.
  • the time-varying photoplethysmographic signal is caused only by changes in the volume of arterial blood associated with the pumping action of the heart, and therefore, to the cardiac cycle and that only two derivatives of hemoglobin .
  • the oxygen bound hemoglobin (oxyhemoglobin or HbO2) and the non-bound hemoglobin (de-oxyhemoglobin or RHb) absorb part of the applied optical radiation. Therefore it is necessary - TO -
  • the majority of the pulse oximeters use as sources of the optical radiation electroluminescent diodes (Light Emitting Diodes, LEDs) with emissions in the zones of 630-660 nm and 880-940 nm.
  • Examples of such oximeters are described in US Patent 4,167,331, US Patent 4,407,290, US Patent 5,203,329, WO / 1995/012349, and WO / 1996/028085, among others.
  • the use of laser diodes as sources of such radiation is also possible, as described in US Patent 5,318,022, WO / 1996/041566, WO / 1997/049330 and US Patent 6,253,097, among others.
  • the oxygen saturation in the tissue is calculated, after obtaining in each of the wavelengths where said saturation is determined, the quotient value between the pulsatile component of the photoplethysmographic signal and the corresponding constant component.
  • the estimation of the value of the pulsatile component is the most critical phase in any algorithm for processing the measurements obtained by the pulse oximeter.
  • Different approaches have been proposed to develop these algorithms, with the aim of eliminating the effects of the "noise" implicit in any determination and the errors that may be generated, either by the different manipulations that the surgeon must perform during the intervention, or by the own movements of the instrument and / or the organ analyzed, while maintaining the ability to detect signals of different intensity.
  • An exemplary embodiment of one of these algorithms is found in patent document P200501425, "Method for processing photoplethysmographic signals obtained from a person or animal, and an oximeter using said method".
  • the arrangement of its emitting and detecting elements of the optical radiation with respect to the analyzed medium varies as the radiation reflected by said means or Ia must be measured. transmitted through.
  • the reflection sensors can be placed on any pulsatile vascularized surface, but the reflection signal is weaker than the transmission signal and is subject to errors due to the dispersion in the tissue, the specular reflection due to the surface layer of the tissue and a certain "short circuit" of the signal (“shunting") produced between the emitting element and the detector.
  • the transmission sensors must be placed in the parts of the body that can accommodate their emitter (s) and detector (s) elements facing each other, as is the case of the fingers, ear lobe, bridge of the nose , with the disadvantage that these are peripheral and very specific areas. Therefore, although the most widespread practice is the use of pulse oximeters in these areas, in the practice of surgery there is a disadvantage that there are morbid processes related to blood perfusion and oxygenation of tissues, which selectively affect certain organs or tissues without significant impact on the degree of peripheral oxygenation determinable in these areas. Such a situation occurs in cases of ischemia or mesenteric thrombosis, which are often the cause of urgent surgery.
  • transmission photoplethysmography was applied to intraperitoneal organs of animals in an open (non-endoscopic) surgical procedure, using a system based on two laser diodes ("Transmittance photoplethysmography with near-infrared laser diodes in intra-peritoneal organs". SM López -Silva et al. Physiological Measurement. 2006. 27: 1033-1045). Notwithstanding the foregoing, there are no methods, techniques and instruments intended to determine "in situ” and "in vivo" physiological parameters in organs and / or tissues through the application of endoscopic sensors.
  • the present invention combines a sensor composed of light emitting elements and photodetector elements designed to be able to develop measures based on the reflection and / or the transmission of the light signal by a given organ or tissue with endoscopy surgical instruments.
  • This invention consists of a device comprising a probe for endoscopy that incorporates at least one sensor into the cavity made at the patient, capable of detecting optical signals associated with biological parameters.
  • said sensor or sensors are suitable for the application of the principles of photoplethysmography and pulse oximetry and any other based on the emission of an optical signal and Ia reception of the signal reflected or transmitted through a given organ or tissue.
  • This device can incorporate the appropriate mechanisms to place, fix and orient the sensor and thus optimize the signal-to-noise ratio of the measurement.
  • the invention is completed with an external module that includes the electronic control and power supply of the sensor, and amplification, sampling and signal retention.
  • the sensor can be connected to the external module either by cables, or wirelessly.
  • the probe incorporates the corresponding wireless transmission-reception circuits as well as the power supply of these and the sensors by means of batteries.
  • the measured signals are transferred to a computer equipment, where they are processed with computer programs that are implementations of suitable algorithms to be able to be displayed, represented and / or stored as useful data for the operator.
  • the present invention is based on the incorporation of a sensor in an endoscopy instrument, which makes it possible to take advantage of its benefits in exploratory procedures, but especially in surgical procedures (laparoscopic, thoracoscopic, neuroscopic, endovascular, endocavitary, etc.) and achieve The adequate placement, orientation, and even, fixation of said sensor on the organ or tissue to be analyzed, guaranteeing a correct reception of the signals and optimizing the signal-to-noise ratio, in order to measure and present certain biological parameters.
  • This device provides the surgeon and his surgical team with an apparatus that provides the value, in real time, of the measurement of vital parameters of the organs and tissues that are being explored and / or intervened.
  • the device allows applying the principles of photoplethysmography and pulse oximetry and therefore determine the pulse and oxygen saturation in organs or tissues whose blood supply is variable over time.
  • the advantages of this device are a) its "in situ" applicability, providing the required measure instantly; b) the possible damage to the intervened organs or tissues is minimal, because their interaction with them is practically null, based on their transmission or reflection properties; c) simple and functional design; d) the elements that make up the sensor or sensors are available in the market at a reduced cost; e) maintenance is simple, requiring only a cleaning and sterilization similar to that of any surgical instrument or the use of transparent, sterilized and biologically inert plastic covers, commercially available and intended for use with existing biomedical instruments.
  • the device of the invention comprises ( Figure 1) a probe whose main body is a hollow cylindrical tube (1), of any biologically inert material, and at whose front end there are one or several opto-electronic sensors.
  • This tube must have a suitable outer diameter so that it can pass through the hole of a trocar (2) coupled to the surgical incision to avoid its closure and better conduct the surgical instruments.
  • the holes of said trocars have a diameter between 6 and 10 millimeters.
  • the sensor or sensors are coupled on one end of the same modified tube to offer a flat surface for placement (3a), or on the flat surface of one or two pieces (3b) that form fingers or arms, in which at least one will be attached to the tube by an axis perpendicular to the axis of said tube, so that said finger or fingers can rotate on said axis or perpendicular axes, thus forming a clamp in the case of two fingers or arms (3b in Ia Figure 1C).
  • Said clamp It can in turn be modified to optimize the manipulation of the organ or tissue and the placement of the sensor with respect to it.
  • one or two of said fingers may contain an axis transverse to the plane defined by its opening angle, so that when said opening is made, the sensor or sensors are better positioned with respect to the organ or tissue (4) and / or each other (an example of said modification is represented in Figure 8).
  • the diameter of the inner hollow of the tube must allow to house inside the wires and cables (5) necessary for the feeding and electronic control of the sensor or sensors. Said cables will exit through the rear area of said tube to be able to connect with the power and control electronics.
  • the device has in its back one or several thickening (6a in Figure 1A) that facilitate its clamping and manipulation of the probe by the surgeon.
  • the device incorporates handles (6b in Figures 1 B and 1C) on the back of the probe that facilitate this holding and handling.
  • at least one of said handles can be mobile, allowing the finger or fingers that house the sensors to be operated by means of a traction mechanism, so as to vary their angle or opening, which allows the sensor to be properly placed on the organ or tissue to be analyzed and even when the sensor or sensors are incorporated in a clamp, manipulate said organ or tissue and leave them fixed on an area thereof during the measurement period.
  • the hollow of the tube must have a sufficient diameter to house inside it both the cables necessary for the electronic feeding and control of the sensor or sensors and the means necessary to operate the moving finger or fingers.
  • the sensor includes: a) one or more microelectronic elements that emit light of different wavelengths, constituting the emitting elements, which can be electroluminescent diodes (LEDs), superluminescent diodes (SLDs), laser diodes (LD), or any opto-electronic element that emits optical radiation of specific wavelengths; b) one or more photodetector elements, which can be silicon photodiodes, phototransistors, or any optoelectronic element that detects the optical radiation of the wavelengths emitted by the emitting elements and produces an electrical signal proportional to the amount of light detected .
  • LEDs electroluminescent diodes
  • SLDs superluminescent diodes
  • LD laser diodes
  • the hollow of the tube must have a sufficient diameter to house inside it both the cables necessary for the electronic feeding
  • the specific characteristics of the sensor or sensors depend on the precise nature of the application.
  • the range of wavelengths of the optical emission to be used, the activation regime of the emitters, the particular and specific characteristics of the optical detectors, and the spatial arrangement of emitter / s and detector / s with respect to the organ or tissue analyzed are variable parameters in each particular embodiment of the invention.
  • the possible configurations of the invention can be summarized as follows: a) to measure by reflection the emitters and detectors are placed in the same plane; b) to carry out measurement by transmission, the emitters and detectors are placed in two planes facing each other; c) to perform measurements by reflection and transmission with the same device, the two previous configurations are combined.
  • the light emitters can be LEDs (as illustrated in Figures 2 to 7, and in Figures 8A to 8F) in encapsulation for surface mounting, whether said encapsulation applied individually to each LED (Ia adopted by the devices shown in said figures) or together with a group thereof.
  • the light emitters can be of the laser diode type, as shown in Figure 8G.
  • the device of the invention can incorporate any other electronic element that emits optical radiation in a specific wavelength (such as those in the range of 400 to 1000 nm, for the specific embodiment of a device for photoplethysmography and / or pulse oximetry) and whose size allows adapting to the probe or tube that forms the main body of the device.
  • the number of emitters is 4 per sensor, as shown in Figures 2 to 8.
  • the sensor also incorporates one or more detection elements of the optical signal transmitted or reflected by the medium, organ or tissue.
  • said detectors are silicon photodiodes, but also the device of the invention can incorporate any other opto-electronic element that allows the reception of light in the same wavelengths as that generated by the emitters, the generation of an electrical signal proportional to the amount of light received in a given wavelength, its electronic control and a size that allows it to be coupled to the probe or tube that forms the main body of the device in a useful arrangement for the reception of the signal bright. Similar to what is indicated for the emitting elements, not only the type of detector, but also its quantity and arrangement (geometry and distance with respect to the emitters) may vary.
  • the emitting and detecting elements will be mounted on one or more flat surfaces of the anterior end of the modified suitable probe ( Figure 1A) or on one or more flat surfaces of one or more support pieces, respectively.
  • the preferred arrangement will be the assembly of the emitting elements on the surfaces so that the direction in which the light emitted is perpendicular to said surface.
  • the surfaces, whether practiced on the probe itself or on the support pieces, will be fixed when they cannot vary their spatial position with respect to the probe (rigid configuration, Figures 1A, 2, 8A and 8G) or mobile, when it has been provided with the less one of the support pieces with an axis that allows it to vary its spatial position with respect to the probe when rotating on said axis.
  • said axis is perpendicular to the longitudinal axis of the probe and the spatial position of the support surface (s) may vary perpendicular to the plane defined by said surfaces (configuration with variable application angle, Figures 1 B and 1C , 3 to 7, and 8B to F).
  • the senor presents the configuration for reflection measurement, characterized in that both the emitting and detecting elements are resting on the same flat surface.
  • the emitting element or elements When supporting the sensor on an organ or tissue, the emitting element or elements will illuminate it with optical radiations in each of the wavelengths emitted by each of the emitters and the detecting element (s) will collect the light of the same wavelengths of the incident emission that said organs and tissues reflect and that will vary according to the physiological state determinable by the parameter to be measured with the sensor.
  • the reflection sensor may adopt the rigid configurations ( Figures 1A, 2, 8A and 8G) or with an angle of Variable application ( Figures 1 B, 3, 4, 6, 7, and 8B to 8F) as defined above.
  • the senor adopts the configuration for transmission measurement, characterized in that the emitting elements are resting on a flat surface other than that in which the detectors are located.
  • the planes of these surfaces must be as parallel as possible, so that the emitting and detecting elements are as closely opposite as possible.
  • the arrangement of the support pieces must be such that they allow placing the organ or tissue that is to be explored between the emitters and the detectors, but avoiding damaging the organ or tissue.
  • both pieces can be rigid, so that they do not vary their spatial position with respect to the probe
  • the two pieces are joined to the probe through one or two rear axes, adopting the arrangement of a clamp that can be opened at different perpendicular angles ( Figures 6 and 7).
  • the clamp incorporates in each of its fingers a second axis parallel to the common axis of both fingers, whereby it is facilitated that the emitters and detectors are faced in parallel with each other even in the arrangements openings of the clamp ( Figure 8).
  • the senor by transmission it must comprise a portion of the organ or tissue to be analyzed between its emitting and detecting elements, so that the emitting element or elements will illuminate said portion with optical radiation of the different wavelengths and the or The detecting elements will collect the light of the same wavelengths that said organ or tissue has passed through and which will vary according to the physiological state determined by the parameter to be measured with the sensor.
  • the very nature of the emitting and detecting elements does not determine which is the configuration of the sensor, since although emitting elements may occur or detectors more suitable for one or another configuration, it is possible to perform any of them using emitting elements and detectors of the same nature.
  • an emitting element can be part of a sensor at the same time by reflection or by transmission, depending on the relative arrangement of the detector element with respect to it.
  • a detector element can be part of a sensor at the same time by reflection or by transmission, depending on the relative arrangement of the emitting element with respect to it.
  • a particular embodiment of the present invention consists of a probe that combines a sensor by reflection and transmission with common elements, resulting in the hybrid configuration shown in Figures 7 and 8.
  • At least one of the support pieces It couples emitting and detecting elements on the same flat surface, adopting the configuration by reflection and the other support piece engages at least one detector facing said emitting elements so that the sensor adopts the configuration by transmission. Therefore, in this case, the emitting elements are part of both the reflection and transmission sensors and their application to one or the other will depend on the electronic control. In other possible configurations each support piece can couple a combination of emitting and detecting elements so that all of them can form sensor configurations by reflection and transmission.
  • the use of emitters with multiple wavelengths, as well as the arrangement of the detectors with respect to the emitters (multiple distances and geometries) allow the differential and integral analysis of different areas of organs and / or tissues.
  • the clock and control phase generates different firing pulses, some aimed at a power phase to activate each of the transmitters (AE1, AE2, AE3, AE4), and others aimed at the amplification, sampling and retention phase (MR1 , MR2, MR3, MR4) of the signals registered by the detector or detectors (D), previously pre-amplified and amplified by the corresponding electronic circuits.
  • the activation of each of the transmitters is synchronized to occur with a time lag between them and at the same time it is synchronized with the different channels or circuits of sampling and retention. This synchronization makes it possible to distinguish at all times to which transmitter (and therefore to which wavelength) a specific signal collected by a detector corresponds.
  • the number of channels will be equal to the product of the number of emitters emitting at different wavelengths by the number of independent detectors.
  • the number of channels is equal to that of transmitters (four), as a single detector or several detectors are used that act as one only when they are connected in parallel.
  • the number of channels will be double the number of emitting elements.
  • the number of channels will be increased according to the product of the number of detectors by the number of emitters.
  • the analog signals conveniently separated on independent channels pass to the analog inputs (EA1, EA2, EA3, EA4) of a electronic circuit for analog-digital conversion.
  • said circuit is a data acquisition card that can be inserted or connected to a computer, which stores the digital signals and processes them through programs based on the appropriate algorithms, to generate a graphical representation useful for monitoring the desired physiological parameter.
  • the specific algorithms for obtaining and monitoring parameters of interest obtained by photoplethysmography and pulse oximetry are aimed at eliminating noise and artifacts caused by movement due to the manipulations that the surgeon must perform during the intervention or to their own organ movements
  • the preferred objective is to provide direct and real-time measurements of the parameters related to perfusion and blood oxygenation, in particular the heart rate or rhythm or pulse by means of photoplethysmography and / or oxygen saturation by means of pulse oximetry.
  • the pulsatile frequency is obtained, in principle from any emitting channel, although depending on the organ or tissue some wavelengths may be more sensitive than others. Applying the principles of pulse oximetry, from these same photoplethysmographic signals we can obtain the oxygen saturation values of the organs or tissues explored, provided that the signals originating in at least two different wavelengths are considered in accordance with the principles stated previously.
  • the present invention in its particular embodiment as an endoscopic pulse oximeter, allows the operator in the course of a surgical intervention (for example, in a transplant or implant) to check directly and instantaneously if the intervened organ or tissue is adequately receiving the blood from the patient (measurement of the pulsatile level), and / or if there is an adequate exchange of oxygen in the organ or tissue (measurement of oxygen saturation). It can also be useful to assess the extent to which a tissue or organ must be sacrificed to the time to remove, it is possible to make comparisons of the determinations in organs, tissues or healthy areas with respect to those made in the damaged, carcinogenic or with necrosis. These important measures allow the surgeon to assess "in situ" the situation of the tissue or organ, before concluding the surgical intervention, which is undoubtedly an aid to achieve the success of the intervention.
  • FIG. 1 Diagram of three configurations of the device of the invention.
  • the device consists of a probe or hollow tube (1), which is introduced through a trocar (2) coupled to the surgical incision and which at its front end has one or several opto-electronic sensors. These sensors are mounted on a flat surface made in the same tube (3a in Figure 1A) or on the flat surface of a moving part (3b in Figures 1 B and 1C) that can rotate thanks to a shaft attached to the tube and that it can be faced with another similar piece, so that it forms a clamp (Figure 1C), being able to find elements of the sensor only in one of said pieces, which make up the arms or fingers of said clamp, or in both arms or fingers, according to the desired configuration.
  • the manipulation of the probe allows the placement of the sensors with respect to the organ or tissue to be analyzed (4).
  • the sensors have connection cables that go through the inside of the probe and exit through its back (5) to connect with the power and control electronics.
  • the device optionally presents a series of thickening on the back of the tube that serves as a handle (6a in Figure 1A) or handles (6b in Figures 1 B and 1C).
  • the handles also allow controlling the movement of the part or parts that support the sensor or sensors.
  • FIG. 2 Diagram of the device with the sensor by reflection, mounted on a rigid probe.
  • the anterior and posterior ends of the device seen from above (A) and laterally (B) are shown.
  • the front end of the tube of the probe is modified to present a smooth surface (1) on which the sensor is located, which consists of four emitting elements (2, 3, 4 and 5) that can each emit light in a different wavelength and two detector elements (6), the different elements having cable connections (7) that go inside the tube of the probe (8).
  • In the back of said probe there is one or several thickening that serve as a handle (9).
  • the connection cables (7) of the elements of the optical sensor to the power and control electronics come out.
  • Figure 3 Diagram of the device with the sensor by reflection, mounted on a piece of variable angle.
  • the front end of the probe is shown, with view (A) of the rear face and (B) of the front face of the moving part (1) that accommodates the sensor; and side views, the piece that accommodates it aligned (C) or forming an angle (D) with respect to the longitudinal axis of the tube (2) of the probe.
  • This piece can rotate thanks to its coupling by an axis (3) transverse to the longitudinal axis of the probe.
  • the sensor elements are coupled on the inner surface (4) of said part, and are similar to those represented in Figure 2: four emitting elements (5, 6, 7 and 8) and two detecting elements (9), having the different elements connections by cables (10) that go inside the tube of the probe, generally grouped within a common tubular envelope (11).
  • Figure 4 Diagram of the device with the sensor by reflection, mounted on a piece of variable angle that is part of a gripper.
  • the front end of the tube of the probe is shown, with view (A) of the outer face (1) of any of the pieces that form the fingers of the clamp; (B) of the inner face (2) of the finger that does not accommodate the sensor; (C) of the inner face (3) of the finger that accommodates the sensor; and side views, the fingers being aligned (D) or forming an angle (E) to each other.
  • These fingers can rotate thanks to their coupling to the tube (4) of the probe by an axis (5) transverse to the longitudinal axis of said tube.
  • the sensor elements are coupled on the inner surface (3) of one of the fingers of the clip, and are similar to those shown in Figures 2 and 3: four emitting elements (6, 7, 8 and 9) and two elements detectors (10), the different elements having cable connections (11) that go inside the tube of the probe, generally grouped within a common tubular envelope (12).
  • Figure 5 Diagram of the device with the sensor in configuration for transmission, mounted on the fingers of a clamp. The anterior end of the tube of the probe is shown, with views (A) of the outer face
  • the front end of the tube of the probe is shown, with views (A) of the outer face (1) of any of the pieces that form the fingers of the clamp; (B) of the inner face (2) of the finger that accommodates the sensor sensing element in transmission configuration; (C) of the inner face (3) of the finger that accommodates the emitting elements for the reflection and transmission configuration and the detecting elements for the reflection configuration; and lateral, the fingers (D) being aligned or (E) forming an angle to each other.
  • These fingers can rotate thanks to their coupling to the tube of the probe (4) by an axis (5) transverse to the longitudinal axis of said tube.
  • the surface of one of the fingers (2) houses a single detector element (6) for the transmission configuration while the surface of the other finger (3) houses four emitting elements (7, 8, 9 and 10) that serve for the configuration by transmission when they work synchronously with the detector element that is in the opposite position on the other finger (6) and for the configuration by reflection when they work synchronously with the two detector elements (11) that are on the same surface as said emitting elements .
  • the different elements have cable connections (12) that go inside the tube of the probe, generally grouped within a common tubular envelope (13).
  • FIG 7 Diagram of the device with the sensor in hybrid configuration, mounted on the fingers of a parallel opening clamp. Two side views of the device similar to that described in Figure 6 are shown except that the fingers of the clip each contain a transverse axis (1) to its opening plane. In this way, the opening of the clamp rotating on the axis (2) that joins the tube of the probe allows the surfaces that house the sensor elements - four emitting elements of which two (3 and 4) can be seen in the side view, and three sensing elements, one that acts for Ia configuration by transmission (5) and two for the configuration by reflection (6) - be kept in spatial planes parallel to that defined by the longitudinal axes of the tube of the probe and the opening axes of the clamp, which optimizes its placement with respect to the organ or tissue, and the temporary fixation on it.
  • Figure 8 Photographs of embodiments of the device of the invention.
  • A rigid probe in reflection configuration
  • B probe with variable angle piece that couples a sensor by reflection, top view of the inner face of said piece, coupling the sensor
  • C and D side views of the same piece aligned with the axis of the device tube (C) or at an angle with respect to said axis of the tube (D);
  • E and F side views of probe with clamp that incorporates in one of its fingers a sensor in reflection configuration, in closed position (E) and open (F).
  • E open
  • four emitting LEDs with infrared wavelength emissions are used as emitting elements and, as detecting elements, two silicon p-i-n photodiodes.
  • Figure G view of the probe head incorporating a sensor in reflection configuration with 4 laser diodes and a silicon photodiode.
  • FIG. 9 Diagram of the feeding and control system of the device of the invention.
  • the sensor consists of 4 emitting elements (E1, E2, E3, E4) and a detector element (D).
  • Each emitter element has its corresponding power supply phase for activation (AE1, AE2, AE3, AE4).
  • Another phase controls the retention and sampling of signals by components MR1, MR2, MR3 and MR4, which collect the signals generated by the detector, previously amplified.
  • Both phases are coordinated thanks to the clock and control circuit so that the analog signals generated by the detector are separated into independent channels (in this case, when there is only one detector, one channel for each of the transmitters with different wavelength) and pass to the analog inputs (EA1, EA2, EA3 and EA4) of the data acquisition card, which in turn transmits the digital signals to the computer.
  • the analog signals generated by the detector are separated into independent channels (in this case, when there is only one detector, one channel for each of the transmitters with different wavelength) and pass to the analog inputs (EA1, EA2, EA3 and EA4) of the data acquisition card, which in turn transmits the digital signals to the computer.
  • Figure 10 Application of the device of the invention to different organs of the abdominal cavity of a pig.
  • a laparoscopic surgical operation was performed on a pig and the rigid probe was used in reflex configuration.
  • the sensor consisted of four LEDs as emitters and a silicon photodiode as a detector and was as a whole protected by a plastic sheath.
  • the device was applied to the measurement of the pulse constants and oxygen saturation in the gastroepiploic artery (A), the liver (B), the intestine (C) and the abdominal wall (D).
  • the invention Photoplethysmograms obtained with the device of the invention are shown acting as a pulse oximeter during a laparoscopic surgical operation performed on a pig.
  • the device used was a rigid probe with a reflection sensor, said sensor consisting of four LEDs as emitters (in this case emitting radiation with near-infrared wavelengths, LEDniri, LEDnir2, LEDnir3 and LEDnir4) and a silicon photodiode as detector.
  • the data shown correspond to those obtained for the gastroepiploic artery at baseline.
  • Graph A shows the intensity in volts of the electronic signal obtained during a determination of 10 seconds duration.
  • Graph B shows the representation of the pulse values obtained from the photoplethysmograms shown in Figure A after processing.
  • the average pulse value was 117 pulses per minute in all cases, being very similar to that of the heart rate determined by electrocardiography (118 beats per minute). In addition, the variability of said value was practically zero, given that the standard deviation was 0 (zero), demonstrating the effectiveness of the application of the device.
  • Example 1 Rigid probe with reflection sensor.
  • the optical sensor consists of four emitters (2 to 5, in this example four individualized LEDs in surface mount encapsulation) and two detectors (6, in this example two silicon pin photodiodes, also surface mount).
  • the device shown in Figure 8A four LEDs with emissions in near-infrared wavelengths are used and as detectors two BPW34S silicon pin photodiodes.
  • the set of emitting and detecting elements is mounted on the modified end of the cylindrical tube that constitutes the main body of the probe (8), so that it offers a flat surface for assembly of these elements.
  • FIG. 1A shows an example of application of this probe, in which it is introduced into the abdominal cavity through the hole of a trocar (2) that crosses the abdominal wall. The characteristics of the probe allow its manipulation with the handle (6a) and reach the organ or tissue (4) for monitoring, placing the sensor on it.
  • a second embodiment of the present invention is shown in Figures 1 B, 3 and 8B to 8D.
  • the senor is similar to that described in the previous example: four emitting elements (5 to 8, in this example, four individualized LEDs in surface mount encapsulation) and two detectors and two detectors (9, in this example, two silicon pin photodiodes in encapsulation for surface mounting), connected by cables (10) that go inside a tube that goes inside the tube of the probe (2) and exit at its rear end (11) towards The control electronics.
  • this sensor is placed on a flat surface (4) inside an elongated part (1) with variable application angle thanks to the fact that it joins the main body of the tube of the probe (2) by an axis (3).
  • the rotational movement of this piece (1) on said axis (3) can be controlled thanks to a mechanism at the rear end of the probe.
  • this mechanism consists of handles (6b) that allow to exert a traction movement transmitted to said piece (1) by the tube (11) that contains the cables and that is housed inside the tube of the probe (2), allowing to vary its angle as the handles are actuated.
  • the variation of the angle that forms the support piece of the sensor allows to improve the coupling of the optical sensor with the analyzed medium.
  • FIG 1 B an example of application of this probe is shown, in which it is introduced into the abdominal cavity through the hole of a trocar (2) that crosses the abdominal wall.
  • the characteristics of the probe allow its manipulation with the handle (6b) and reach the organ or tissue (4) for monitoring, placing the sensor on it in an optimal way, which results in a better determination while reducing the manipulation to be exerted on said organ or tissue.
  • Example 3. Probe with reflection sensor coupled to a clamp.
  • the third embodiment of the present invention is shown in Figures 4, 8E and 8F.
  • the senor is similar to that described in the previous examples: four emitters (6 to 9, in this example, four individualized LEDs in surface mount encapsulation) and two detectors (10, in this example, two silicon pin photodiodes in encapsulation for surface mounting), connected by cables (11) that go inside a tube that goes inside the tube of the probe (4) and leave at its rear end (12) towards the control electronics .
  • this sensor is placed on a flat surface (3) inside an elongated piece with variable application angle (Figure 5D) thanks to the fact that it joins the main body of the tube of the probe by an axis (5).
  • this piece is facing a similar one that is capable of varying its angle on the same axis or on a parallel one, so that each of these pieces is constituted in the finger of a clamp with variable angle opening .
  • This embodiment allows the probe to be positioned and temporarily fixed in a certain area of the organ or tissue provided that it can be understood between both fingers, which makes it easier to ensure that all determinations over time are carried out in The same area.
  • the manipulation mechanism can be identical to the previous embodiment, although the handles can control the opening of both pieces.
  • Example 4 Probe with transmission sensor coupled to a clamp.
  • the fourth embodiment of the present invention is shown in Figure 1C and 5.
  • the sensor is coupled on the flat and inner surfaces (2 and 3) of the fingers of a clamp similar to Ia of the previous example, but unlike that, one of said fingers contains the emitting elements (7 to 10, in this example, four individualized LEDs in surface mounted encapsulation) and a detector element (6), while the previous example It contains two detectors (10, two silicon pin photodiodes in encapsulation for surface mounting). Both groups of elements must be fixed to the fingers of the clamp so that they are facing each other when the clamp is closed.
  • Example 5. Probe with hybrid sensor (combination of sensor by transmission and reflection) coupled in a clamp.
  • the fifth embodiment of the present invention is shown in Figures 6 and 7.
  • the clip houses a detector element (6) on the flat surface of the interior of one of its fingers and in The corresponding flat surface of the other finger, and facing said detector element, a sensor is set by full reflection, in which, as in the examples of embodiments 1 to 3, the emitting elements (7 to 10, in the Illustrated example four individualized LEDs in surface mount encapsulation) and the detectors (11, in the illustrated example, two silicon pin photodiodes) are located on the same flat surface.
  • the emitting elements must face the detector of the other finger of the clamp, so that they can act both for the determination by reflection, in which case the signal is detected by the detectors (11) placed on the same surface, as by transmission, in which case the signal is detected by the detector that is located on the inner surface of the other finger of the clip (6).
  • each of the fingers of the clip contains a second axis (1) parallel to the common axis of both (2), which allows the surfaces that house the sensor elements (3 to 6) are better facing each other, facilitating on the one hand the manipulation and, if necessary, keeping the sensors fixed over a certain area during the different measurements over time and, on the other , the confrontation of the sensor elements by transmission to optimize said measurements.
  • the parallel opening clamp shown in Figure 7 can only house one of the two configurations, by reflection or by transmission, similar to the examples shown in Figures 4 and 5, respectively.
  • a probe with reflection sensor with parallel displacement can be modified and turned out for application on the organ, analogously to the example of reflection sensor with variable application angle (Figure 3).
  • Example 6 Determination of physiological parameters using the device of the invention.
  • Several laparoscopic surgical operations were performed in pigs, following the guidelines of Royal Decree 1201/2005 on the protection of animals used for experimentation and other scientific purposes.
  • photoplethysmographic and pulse oximetric measurements were made in different areas of the gastroepiploic artery (Figure 10A), liver ( Figure 10B), intestine (Figure 10C) and abdominal wall (Figure 10D).
  • the pigs were then subjected to selective vascular occlusion of arterial and venous territories at decreasing inspiratory oxygen concentrations (02) (100%, 66%, 33% and 17%).
  • the processing of the signals obtained by the device acting as a laparoscopic pulse oximeter allows to obtain pulse and oxygen saturation values.
  • the measurement in the gastroepiploic artery of a pig in basal state using for each of the 4 LED emitters of the sensor a wavelength in the near infrared (denominated nir1, nir2, nir3 and nir4) carried out over 10 seconds originated the electronic signals shown in Figure 11A.
  • These signals once processed, allowed to obtain the pulse values in beats per minute (ppm) shown in Figure 11 B, their average values and standard deviations.
  • the heart rate value in beats per minute
  • the average value of the pulse determined by application of the probe was in all cases 117 beats per minute (very similar to the heart rate determined by electrocardiography, which was 118 beats per minute) and that of the standard deviation was 0 (zero ), demonstrating the effectiveness of the application of the device.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Ophthalmology & Optometry (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un endoscope dont la sonde tubulaire comprend, à l'extrémité qui est introduite dans le patient, un ou plusieurs éléments opto-électroniques qui détectent des signaux optiques associés à un paramètre de l'activité physiologique des organes, tissus et/ou régions spécifiques de ces derniers, et qui produisent des signaux électriques proportionnels à la valeur dudit paramètre. Les capteurs comprennent des éléments électroniques émetteurs de rayonnement optique de longueurs d'onde déterminées et des éléments électroniques détecteurs dudit rayonnnement. La disposition spatiale distincte des éléments dans la sonde permet de mesurer la quantité de rayonnement d'une longueur d'onde donnée que l'organe, le tissu ou une région de ces derniers réfléchit (mode de fonctionnement par réflexion) ou celle qui est transmise à travers ledit organe, ledit tissu ou lesdites régions (mode de fonctionnement par transmission), ou les deux. Les éléments électroniques des capteurs peuvent être disposés de manière fixe dans la sonde ou dans des pièces mobiles afin d'optimiser leur utilisation.
PCT/ES2009/070004 2008-01-16 2009-01-16 Sonde endoscopique à capteur opto-électronique à usage diagnostique et chirurgical WO2009090293A1 (fr)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4167331A (en) * 1976-12-20 1979-09-11 Hewlett-Packard Company Multi-wavelength incremental absorbence oximeter
US5318022A (en) * 1991-03-01 1994-06-07 John Taboada Method and apparatus for determining hemoglobin oxygenation such as in ocular and other vascular beds
DE19703220A1 (de) * 1996-01-30 1997-07-31 Hoek Instr Ab Sensor für Pulsoximetrie
US20030225337A1 (en) * 2002-01-31 2003-12-04 Dolphin Medical, Inc. Separating motion from cardiac signals using second order derivative of the photo-plethysmogram and fast fourier transforms
US20050148842A1 (en) * 2003-12-22 2005-07-07 Leming Wang Positioning devices and methods for in vivo wireless imaging capsules
WO2005087097A1 (fr) * 2004-03-08 2005-09-22 Masimo Corporation Systeme de parametres physiologiques
ES2276594B1 (es) * 2005-06-13 2008-06-16 Consejo Superior Investig. Cientificas Metodo para procesar señales fotopletismograficas obtenidas de una persona o animal, y oximetro que utiliza dicho metodo.

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4167331A (en) * 1976-12-20 1979-09-11 Hewlett-Packard Company Multi-wavelength incremental absorbence oximeter
US5318022A (en) * 1991-03-01 1994-06-07 John Taboada Method and apparatus for determining hemoglobin oxygenation such as in ocular and other vascular beds
DE19703220A1 (de) * 1996-01-30 1997-07-31 Hoek Instr Ab Sensor für Pulsoximetrie
US20030225337A1 (en) * 2002-01-31 2003-12-04 Dolphin Medical, Inc. Separating motion from cardiac signals using second order derivative of the photo-plethysmogram and fast fourier transforms
US20050148842A1 (en) * 2003-12-22 2005-07-07 Leming Wang Positioning devices and methods for in vivo wireless imaging capsules
WO2005087097A1 (fr) * 2004-03-08 2005-09-22 Masimo Corporation Systeme de parametres physiologiques
ES2276594B1 (es) * 2005-06-13 2008-06-16 Consejo Superior Investig. Cientificas Metodo para procesar señales fotopletismograficas obtenidas de una persona o animal, y oximetro que utiliza dicho metodo.

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
S. M. LÓPEZ SILVA ET AL., UTILITY OF TRANSMITTANCE PHOTOPLETHYSMOGRAPHY WITH NEAR INFRARED LASER DIODES FOR THE STUDY OF VISCERAL PERFUSION: PRELIMINARY STUDY, 7 July 2005 (2005-07-07) *

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