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WO2018051111A1 - Appareil et procédé de détection - Google Patents

Appareil et procédé de détection Download PDF

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Publication number
WO2018051111A1
WO2018051111A1 PCT/GB2017/052734 GB2017052734W WO2018051111A1 WO 2018051111 A1 WO2018051111 A1 WO 2018051111A1 GB 2017052734 W GB2017052734 W GB 2017052734W WO 2018051111 A1 WO2018051111 A1 WO 2018051111A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensing apparatus
pressure
fluid delivery
insert
elongate insert
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2017/052734
Other languages
English (en)
Inventor
Paul Weinberger
Graham Scott Gutsell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DIASOLVE Ltd
Original Assignee
DIASOLVE Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by DIASOLVE Ltd filed Critical DIASOLVE Ltd
Publication of WO2018051111A1 publication Critical patent/WO2018051111A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02158—Measuring pressure in heart or blood vessels by means inserted into the body provided with two or more sensor elements
    • 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
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • 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
    • A61B5/6847—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 mounted on an invasive device
    • A61B5/6852—Catheters

Definitions

  • This invention relates to sensing apparatus for use with fluid delivery apparatus for use with a system containing or conveying fluid, and a method for determining the position of an elongate insert within the fluid delivery apparatus.
  • the invention is applicable to conduits, pipes or tubes that provide access to regions of a system that would otherwise be difficult to reach, and especially so where wires, cables, tools and the like need to be introduced along such access conduits.
  • the invention is particularly applicable to medical catheters into which elongate inserts, such as guide wires, microcatheters, tools and devices are introduced.
  • the system is an organ or the vascular system of a patient's body.
  • the system is the heart or coronary arteries of a patient's body
  • the access conduit is typically a guide catheter
  • the insert is typically a guide wire, or more specifically, a pressure wire that contains a miniaturized pressure sensor at or near its distal tip for measuring the local, instantaneous pressure at different locations around the heart and the coronary arteries.
  • interventional cardiology procedures it is normal practice to collect continuous x-ray images of the heart by means of an x-ray source and a digital image capture device, positioned on opposite sides of the patient.
  • the FFR procedure can involve measuring the pressure drop across a stenosis in a coronary artery by comparing the local pressure downstream of a stenosis with that in the aorta. The latter is normally measured by a proximal sensor located in a fluid line connected to the proximal end of the guide catheter, the distal exit of which is normally located in the aorta.
  • the device includes a differential pressure sensor to measure pressure drop across an internal orifice, a wireless transmitter to communicate the information in real-time to the proximal pressure sensor and/or a display unit and a small battery to power the drive electronics associated with the above.
  • a wire device is inserted along the guide catheter and is used to collect data of a form that can be processed into visual images of the interior structure of the arteries, including any diseased regions, which are then displayed to the cardiologist on a monitor. It is also advantageous to perform a translation of an imaging wire, similar to the pullback described above. To automate pullback movements during pressure wire or imaging procedures, Pullback Devices have been developed to control the wire translation.
  • These comprise a motor-driven sled to which the proximal end of the device is attached and which can be programmed to translate the wire at a constant speed over a specific distance, both of which are predetermined and programmed into the unit.
  • the cardiologist can effect a carefully controlled movement of the device to capture the data of interest along a specific translation path, and in doing so can "encode" each item of data generated by the device with the corresponding position at which it was captured. It is therefore possible for the captured images to be displayed on the same monitor as the x-ray images, superimposed over the same adjacent the sites of interest to which they correspond.
  • sensing apparatus for use with fluid delivery apparatus for use with a system for containing or conveying fluid and comprising a fluid delivery conduit, the sensing apparatus comprising an elongate insert for insertion into the fluid delivery conduit, and sensing means for detecting and measuring the movement and position of the insert within the conduit.
  • the sensing means can detect the linear movement of the insert device by means of a structure introduced into the insert during its manufacturing process.
  • the structure can take the form of an electrical conductor with multiple convolutions, such as those used in handheld digital measurement calipers.
  • the structure can be in the form of a regular texturing of the surface, such as circumferential bands, applied to the outer surface of the insert, analogous to an optical encoder.
  • Such bands can be formed, for example, by laser etching, or by printing.
  • an optical sensor such as a photodiode
  • the intensity of reflected light can be increased by illuminating them with a light source such as an LED.
  • Such systems are well known, and commonly known as an "opto- pair".
  • the combination of the optical sensor and the marked insert device thus constitutes a simple linear encoder that detects movement of the insert as each band passes through the sensor's field of view.
  • said structure can have information encoded within it, analogous to a 2D barcode.
  • a simple system for including data such as the length and diameter of the insert, can also be incorporated.
  • the measurement of movement of the device allows its position to be determined at any point in time relative to a specific starting point in the form of a virtual waymark point.
  • the access conduit is a guide catheter and the elongate insert is a catheter or microcatheter, guide, pressure or imaging wire.
  • the sensing apparatus is for use in an FFR procedure, which may involve measuring the pressure drop across a stenosis in a coronary artery by comparing the local pressure downstream of a stenosis with that in the aorta.
  • the latter is normally measured by a proximal sensor located in a fluid line connected to the proximal end of the guide catheter, the distal exit of which is normally located in the aorta.
  • the sensing apparatus of the present invention may be used in other procedures, such as a coronary flow reserve (CFR) or thermodilution procedure.
  • CFR coronary flow reserve
  • the fluid delivery apparatus may connect to the proximal end of a guide catheter and detect the flow of any liquid, such as a drug, along the same, so that compensation can be made for any change in pressure along the length of the guide catheter due to the same.
  • the fluid delivery apparatus includes a differential pressure sensor to measure pressure drop across an internal orifice, a wireless transmitter to communicate the information in real-time to the proximal pressure sensor and/or a display unit and a small battery to power the drive electronics associated with the above.
  • the insert device is a pressure or imaging wire
  • each item of data that it generates can be encoded with the device's position at the time of capture relative to the virtual waymark point. Data is thus generated in pairs, which in the case of a pressure wire, take the form [position, pressure]. By such means multiple data pairs can be presented in the form of a graph on the display monitor.
  • each step in the staircase can correspond to an individual stenosis that may need to be treated, with a stent for example.
  • the gradient of each step indicates the local rate of pressure drop, and so is a direct indication of the severity of each stenosis.
  • the staircase shape is such that it can be difficult for the cardiologist to determine exactly where each of these steps starts and finishes, and hence it can be difficult to decide on the optimum length of stent to be deployed.
  • the staircase curve can be transformed to show the first derivative of pressure with respect to distance of translation - or dp/dx in mathematical notation, where p is pressure and x is distance of translation from the waymark point.
  • the staircase curve is converted into a series of peaks, the height of which provides a direct indication of the severity of each stenosis. Additionally, it can be much easier with the curve of dp/dx to determine the boundaries of each stenosis for the purpose of selecting the optimum length of stent.
  • the C-arm x-ray is positioned such that the artery is irradiated in an orthogonal direction, then the linear distance along the artery is displayed without foreshortening.
  • the virtual waymark point becomes important so that the start of the graph can be registered with the location in the artery where data capture commenced. This might be done, for example, by a user interface that allows an operator to position a cursor at the waymark point on a displayed image and corresponding mark.
  • a method for determining the position of an elongate insert within a fluid delivery conduit of fluid delivery apparatus comprising detecting and measuring the movement and position of the insert within the conduit using sensing means.
  • the movement and position of the insert within the conduit are preferably measured and detected using the sensing apparatus according to the present invention.
  • the method of the present invention provides information on the relative position of the elongate insert from a given starting, datum or waymark point, and may not attempt to provide information about the absolute position of the elongate insert within the fluid delivery conduit.
  • a cardiologist is principally interested in knowing the distance of various features in an artery from a given waymark point that he/she specifies.
  • Figure 1 illustrates a typical arrangement in a cardiology catheterisation laboratory.
  • Figure 2 illustrates a preferred fluid delivery apparatus for use with the sensing apparatus of the present invention.
  • Figure 3 illustrates the fluid delivery apparatus of Figure 2 incorporating sensing apparatus of an embodiment of the present invention in cross-section viewed in a direction perpendicular to the axis of the elongate insert.
  • Figure 4 illustrates the fluid delivery apparatus incorporating the embodiment of the sensing apparatus of the present invention of Figure 3 in cross-section viewed in a direction parallel to the axis of the elongate insert.
  • Figure 5 illustrates a characteristic "staircase" curve generated using the data points generated by the sensing apparatus and method of the embodiments of the present invention.
  • Figure 6 illustrates a graph of the first derivative of pressure with respect to distance (dp/dx) showing the peaks relating to different stenoses.
  • Figure 7 illustrates how these peaks could be superimposed onto an orthogonal X- ray image of an artery of interest.
  • FIG. 1 illustrates a typical arrangement inside a cardiology catheterisation laboratory (1 ) where the patient (2) is positioned on the table (3).
  • the C-arm X-ray system (4) consists of an X-ray source (5), and a digital imaging device (6).
  • Figure 2 illustrates a preferred fluid delivery apparatus (7) for use with the sensing apparatus of the present invention in cross section.
  • the tapered fitting (8) permits connection to the proximal end of a guide catheter (not shown in this figure).
  • the device entry gland (9) permits a guide, pressure or imaging wire (not shown) to be inserted, and then sealed to prevent the escape of fluid from within the flow paths.
  • the side port (10) allows liquids, such as drugs to be delivered to the patient, or saline to be flushed, prior to insertion into the guide catheter for example.
  • the differential pressure sensor (11) detects difference in pressure across the orifice (12) and hence provides a means to detect the flow rate of any such liquids.
  • Figure 3 shows an optical sensing means (13) in cross-section within the fluid delivery apparatus (7) connected to a guide catheter (14), viewed in a direction perpendicular to the axis of an insert device (15) with marked bands (16) to act as encoding features circumferentially around its outer surface.
  • Wires and other devices similar to the insert device described here may have various printed marker bands (for human readability), and these typically have sufficiently different reflective properties to the normal outer surface to be detectable by the optical sensing means described herein. It will be appreciated that, if a light source is directed towards the surface of the insert device (15), then the intensity of light reflecting off the surface will change between two discrete levels as the insert device translates within the fluid delivery apparatus (7). This changing light level can be detected by a light sensitive transducer, such as a photodiode.
  • a light sensitive transducer such as a photodiode.
  • other features could be applied to the wire in a number of different ways, such as a printed conducting track, similar to the technique used in digital measurement calipers which takes advantage of a capacitive coupling method.
  • the marked bands could either be applied to the surface of the wire by a printing or deposition technique, or by material removal, such chemical etching or laser ablation. Either of these techniques could produce bands with a width or spacing of less than 1 mm. With particular attention to the method of application, the band width or spacing could be as small as 0.1 mm. However, a total pitch-distance of any feature on one band to the corresponding feature on the adjacent band, of around 0.5mm is adequate to provide a sufficiently fine measurement resolution for the movement of the insert device.
  • Such a system of translation detection does not attempt to provide information about the absolute position of the insert device (15) within the fluid delivery apparatus (7). Instead it provides information on the relative translation from a given starting, datum or waymark point.
  • the cardiologist is interested only in knowing the distance of various features in an artery from a given waymark point that he/she specifies.
  • Figure 4 shows an optical sensing means (13), in cross-section within the preferred fluid delivery apparatus (7) viewed in a direction parallel to the axis of the insert device (9) looking in a proximal direction.
  • the two optical devices shown in the form of a light emitting diode and a photodiode, represent the preferred method for illuminating the insert device and detecting the reflected light.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Apparatus For Radiation Diagnosis (AREA)

Abstract

Un appareil de détection est destiné à être utilisé avec un appareil de distribution de liquides (7) destiné à être utilisé avec un système contenant, ou transportant un liquide et comprenant un conduit de distribution de liquides (14), comprenant un insert allongé (15), destiné à être inséré dans le conduit de distribution de liquides, et des détecteurs (13) pour détecter et mesurer le mouvement et la position de l'insert à l'intérieur du conduit. L'insert allongé peut avoir une surface texturée, par exemple des bandes circonférentielles (16). L'appareil de détection peut comprendre un capteur optique pour détecter l'intensité de la lumière réfléchie par la surface de l'insert allongé. L'invention porte également sur un procédé de détermination de la position de l'insert allongé à l'intérieur d'un conduit de distribution de liquides d'un appareil de distribution de liquides, le procédé comprenant la détection et la mesure du mouvement et de la position de l'insert à l'intérieur du conduit à l'aide d'un détecteur.
PCT/GB2017/052734 2016-09-16 2017-09-15 Appareil et procédé de détection Ceased WO2018051111A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1615790.1 2016-09-16
GBGB1615790.1A GB201615790D0 (en) 2016-09-16 2016-09-16 Sensing apparatus and method

Publications (1)

Publication Number Publication Date
WO2018051111A1 true WO2018051111A1 (fr) 2018-03-22

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2017/052734 Ceased WO2018051111A1 (fr) 2016-09-16 2017-09-15 Appareil et procédé de détection

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GB (1) GB201615790D0 (fr)
WO (1) WO2018051111A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022126101A3 (fr) * 2020-12-07 2022-08-25 Frond Medical Inc. Procédés et systèmes d'emplacement d'un dispositif médical dans une lumière corporelle
CN116744847A (zh) * 2020-12-07 2023-09-12 富朗德医疗公司 用于身体内腔医疗设备定位的方法和系统

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6428512B1 (en) * 2000-10-10 2002-08-06 Advanced Cardiovascular Systems, Inc. Guidewire with improved lesion measurement
US20030187369A1 (en) * 2002-03-28 2003-10-02 Lewis Stephen B. Optical pullback sensor for measuring linear displacement of a catheter or other elongate member
US20070060879A1 (en) * 2001-02-15 2007-03-15 Hansen Medical, Inc. Coaxial catheter system
US20130116579A1 (en) * 2011-10-28 2013-05-09 St. Jude Medical Systems Ab Medical system, and a method in relation to the medical system
WO2013136321A1 (fr) * 2012-03-15 2013-09-19 Flip Technologies Limited Cathéter à ballonnet et système et procédé pour déterminer la distance d'un site dans un corps humain ou animal à partir d'un emplacement de référence
US20130261439A1 (en) * 2010-12-09 2013-10-03 Koninklijke Philips Electronics N.V. Interventional apparatus activated computed tomography (ct)
WO2014125497A1 (fr) * 2013-02-18 2014-08-21 Ramot At Tel-Aviv University Ltd. Rigidité artérielle due à une baisse de pression intravasculaire et réduction de l'effet de pression en mode commun
US20160136392A1 (en) * 2014-10-16 2016-05-19 Corindus, Inc. Robotic catheter system with ffr integration

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6428512B1 (en) * 2000-10-10 2002-08-06 Advanced Cardiovascular Systems, Inc. Guidewire with improved lesion measurement
US20070060879A1 (en) * 2001-02-15 2007-03-15 Hansen Medical, Inc. Coaxial catheter system
US20030187369A1 (en) * 2002-03-28 2003-10-02 Lewis Stephen B. Optical pullback sensor for measuring linear displacement of a catheter or other elongate member
US20130261439A1 (en) * 2010-12-09 2013-10-03 Koninklijke Philips Electronics N.V. Interventional apparatus activated computed tomography (ct)
US20130116579A1 (en) * 2011-10-28 2013-05-09 St. Jude Medical Systems Ab Medical system, and a method in relation to the medical system
WO2013136321A1 (fr) * 2012-03-15 2013-09-19 Flip Technologies Limited Cathéter à ballonnet et système et procédé pour déterminer la distance d'un site dans un corps humain ou animal à partir d'un emplacement de référence
WO2014125497A1 (fr) * 2013-02-18 2014-08-21 Ramot At Tel-Aviv University Ltd. Rigidité artérielle due à une baisse de pression intravasculaire et réduction de l'effet de pression en mode commun
US20160136392A1 (en) * 2014-10-16 2016-05-19 Corindus, Inc. Robotic catheter system with ffr integration

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022126101A3 (fr) * 2020-12-07 2022-08-25 Frond Medical Inc. Procédés et systèmes d'emplacement d'un dispositif médical dans une lumière corporelle
CN116744847A (zh) * 2020-12-07 2023-09-12 富朗德医疗公司 用于身体内腔医疗设备定位的方法和系统

Also Published As

Publication number Publication date
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