WO2019045663A2 - Dispositif de mesure à mémoire de forme et d'imagerie 3d pour des procédures d'intervention - Google Patents

Dispositif de mesure à mémoire de forme et d'imagerie 3d pour des procédures d'intervention Download PDF

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Publication number
WO2019045663A2
WO2019045663A2 PCT/TR2018/050287 TR2018050287W WO2019045663A2 WO 2019045663 A2 WO2019045663 A2 WO 2019045663A2 TR 2018050287 W TR2018050287 W TR 2018050287W WO 2019045663 A2 WO2019045663 A2 WO 2019045663A2
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WO
WIPO (PCT)
Prior art keywords
body cavities
holes
measurement
dimensioning
measuring
Prior art date
Application number
PCT/TR2018/050287
Other languages
English (en)
Other versions
WO2019045663A3 (fr
Inventor
Mehmet Hakan Akpinar
Original Assignee
Simeks Tibbi Urunler Sanayi Ve Ticaret Limited Sirketi
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 Simeks Tibbi Urunler Sanayi Ve Ticaret Limited Sirketi filed Critical Simeks Tibbi Urunler Sanayi Ve Ticaret Limited Sirketi
Publication of WO2019045663A2 publication Critical patent/WO2019045663A2/fr
Publication of WO2019045663A3 publication Critical patent/WO2019045663A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording 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
    • 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
    • A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
    • 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • 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
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • 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 pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12—Arrangements for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/48—Diagnostic techniques
    • A61B6/486—Diagnostic techniques involving generating temporal series of image data
    • A61B6/487—Diagnostic techniques involving generating temporal series of image data involving fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments

Definitions

  • the invention relates to a measuring and sizing device which can be used throughout the body in the field of medical diagnostics; is designed to measure a desired size, angle and perspective of cardiovascular geometries and holes and any kind of body cavities that can be reached with catheters and displayed fluoroscopically with angio and/or TTE, TEE devices.
  • MR magnetic resonance imaging
  • CT computed tomography
  • stents, closure devices or transcatheter valves to be enlarged during interventional processes are measured using fluoroscopic angiography, intracardiac echocardiography (ICE), trans oesophageal echocardiography (TEE) and/or transtorasic echocardiography (TTE) .
  • ICE intracardiac echocardiography
  • TTE trans oesophageal echocardiography
  • TTE transtorasic echocardiography
  • both the patient and the team are exposed to more radiation in case of extension of time limit and the greater amount of opaque material used for angiography may have an adverse effect on the patient's kidney function.
  • Echocardiography (ECHO, ultrasound of heart) is a method used to visualize and examine heart and intra cardiac blood via ultra sound waves and provides real time monitoring of anatomic structure and contraction of heart and opening and closing of valves. Echocardiography used in patient with heart defects provides detailed evaluation of heart defects before heart catheterization and angiocardiography. Transesophageal echocardiography which is applied through esophagus is preferred in cases where echocardiography is inadequate and provides clearer and detailed imaging from heart and main veins related to heart. TEE process is performed for detailed analyse of mass and diseases or functions of artificial valves, enlargement and rupture of aorta and presence of a clot in heart which detected by TTE.
  • intracardiac echocardiography has become the preferred imaging method for many medical procedures such as percutaneous atrial septal defect (ASD) closure and defect diameter determination. Further analyses can be performed in body using transtorasic echocardiography which provides imaging of heart and holes in the heart with sound waves.
  • TTE is a completely harmless imaging process but it is not possible to obtain a complete image and measurement in every regon and tissue with TTE.
  • IVUS Intravascular ultrasound
  • sizing balloon In vivo "sizing balloon” is used in case of these devices are insufficient. Only sizing balloon method enters the body but both hydrolic pressure applied by the fluid used to inflate the balloon and the mass of the balloon inflating fluid under effect of gravity cause stretching and enlargement of tissue around intended body hole. Also, it causes a circular measure damaging natural shape of measured area .
  • WO2008072261 discloses a device for measuring the size of an opening in the body, in particular in the heart.
  • EP2545850 discloses a device for measuring an expanded anulus of patients, comprising an orifice-expanding device, a pressure measuring device and a size measuring device.
  • the measurements of the body cavities during the attempts of the used catheters may change so may prevent correct intervention and treatment.
  • the object of the invention which can be used in the whole body in the field of medical diagnosis and which can measure dimensions of cardiovascular geometry and perforations and dimensions of any bodily cavity that can be reached with catheters and imaged with fluoroscopic angio and / or TTE, TEE echo devices is that development of a measuring and sizing device that allows to take measurement of intended angle and perspective making clear on screen of imaging device.
  • Another object of the invention is to simplify the operations by reducing both the elimination of the risks of patient health and the time spent by physician for the case.
  • a further object of the invention is to provide an appropriate detection and treatment of the interstitial spaces which are imaged and / or measured by non-invasive methods, by instantly detecting the changing gauges of the body cavities, after catheter passage or during any interference that may occur during the procedure.
  • Figure 8 Cross sectional view which shows measuring and sizing device equipped with ultrasound crystals
  • Hemostatic valve and locking apparatus 8 Holding apparatus
  • diagnosis which can measure dimensions of cardiovascular geometry and perforations and dimensions of any bodily cavity that can be reached with catheters and imaged with
  • fluoroscopic angio and / or TTE, TEE echo devices and allows to take measurement of intended angle and perspective of all cavities making clear on screen of imaging device.
  • Measuring and sizing device comprises at least two radio-paque markings (4) that can be seen under fluoroscopy and changed due to diameter and dimension of device, a braided and preformed first element (16) that includes at least sixteen metallic wire, a guide wire (1) having a delivery catheter (6) in its outer wall, the longitudinal part of which is in the form of a braiding or woven wire and which guides the dimensioning part in the body.
  • Measuring and sizing device comprises a second element (17) which includes that a soft tip (2) and protection case (3) that is placed to end of device not to damage body and tissue around measuring and sizing device during intervention and procedure and at least two calibration markers (15) that allows imaging of in vivo cavities, a hemostatic valve and locking apparatus (7) attached to delivery catheter (6) which fixes guide wire (1) and prevents movement.
  • Measuring and sizing device comprises a third element (18) which includes a measurement scale (9) having a calibrated measurement scale into a specified distance and provides to measure distance as visually or using ultasound and holding apparatus (8) .
  • Figure 1 shows that original shape memory image of measurement and sizing device.
  • First element (16), second element (17) and third element (18) are given in Figure 10, 11 and 12 respectively.
  • Measuring and sizing device measures distance between radio ⁇ paque markings (4) .
  • Measuring and sizing device provides that the distance between the radiopaque markers is measured visually or the distance between the ultrasonic crystals is measured by the ultrasonic wave. At least two ultrasound crystals (12) can be used in device. Additionally, distal circle and proximal circle in first element (16) is attached to delivery catheter (6) and radio-paque markings (4) or ultasound crystals (12) is in the middle of the first element (16) in measuring and sizing device .
  • measurements are made with a first element (16) advanced from the end portion of the delivery catheter (6) and radiopaque markings (4) at midpoint and / or ultrasound crystals (12) at full measuring point and fluoroscopically verified.
  • the diameter of the cavity or hole to be measured can be monitored by the delivery catheter (6) is moved in and out according to the variation of the distal and proximal diameters of the circle and a correct measurement can be made without applying a radial force whose measurement size is constant or variable.
  • Figure 2 and 4 shows that narrowed image and 3D illustration of measurement area, respectively.
  • Figure 3, 5 and 8 shows cut views of radio-paque marking (4) area, metallic wire (5) area and equipped with ultrasound crystals (12) respectively.
  • the metallic wires (5) in the first element (16) are loaded on the delivery catheter (6) where it is intended to measure within the body. Measurement is provided by the first element (16) conveyed by the delivery catheter (6) to the measurement area is opened to form a narrow neck here with its shape memory feature. In order to be able to measure, a measuring and sizing device which memorized with a larger diameter than the intended size to be measured must be used.
  • calibration markers (15) and ultrasonic crystals (12) can be seen in TTE and TEE, so these measurements can be measured with sound waves without exposure to radiation.
  • the first element (16) comprises at least one crystal cable (13) and ultrasonic crystals (12) that provide electrical transfer between the piezoelectric ultrasonic crystals (12) and the electrical source and the crystal cable (13) is placed to metallic wires (5) in the case of only measurement with sound waves.
  • the signal generator (11) generates short-circuited high-voltage signals to operate the transducer in the desired frequency and spectrum specifications.
  • the socket (14) has eight pins and carries electrical power.
  • Figure 9 shows that the image of the measuring and sizing device with the ultrasonic crystals (12) and the signal generator (11) . If it is intended to measure pressure and gradient differences in the holes and cavities in the body, at least two circular patches (10) are placed in the middle of the first element (16) of the measuring and sizing device.
  • the blood flow is prevented by opening patch material (10) passing through the hole or on both sides of the cavity when the device which is placed in such a way that the half of the first element (16) is located between the hole or the cavity region is pulled by the delivery catheter (6) .
  • Figure 6 and 7 shows original shape memory structure of the measuring and sizing device with the patch material (10) and the measurement region narrowed image, respectively.
  • An interventional measuring and sizing device provides an accurately imaging and measurement of the body cavities via the interventional catheter and is designed to spontaneously expand with a shape memory metallic wire (5) and measures the size of the body cavity at the point where it is delivered.
  • This device can be used with standard equipment and methods in interventional cardiology and radiology.
  • Other catheter types that may be used for interventional procedure can also be used as a measuring device so that saving both time and cost.
  • the metallic wire (5) present in the first element (16) is not braided, at least three metallic wires (5) can be used.
  • the metallic wire (5) in the first element (16) is made from memoryable material such as nickel titanium (nitinol) and the patch material (10) can be made of poly ( tetrafluoroethylene ) (PTFE) , poly (vinyl chloride) (PVC) , dacron or any biocompatible fabric.
  • PTFE poly ( tetrafluoroethylene )
  • PVC poly (vinyl chloride)
  • dacron any biocompatible fabric.
  • gold / platinum iridium can be used.
  • the invention relates to a measuring and sizing device which can be used throughout the body in the field of medical diagnostics; provides to measure a desired size, angle and perspective of cardiovascular geometries and holes and any kind of body cavities that can be reached with catheters and displayed fluoroscopically with angio and/or TTE, TEE devices safely and precisely and shows superiority to different imaging methods .

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Length-Measuring Devices Using Wave Or Particle Radiation (AREA)

Abstract

L'invention est destinée aux domaines des mesures d'interventions médicales et d'imagerie sûres dans toutes les cavités corporelles internes et les orifices ayant des anatomies similaires. Avec ses marqueurs, le dispositif peut mesurer des distances dans des modes angiographiques ou échographiques, et mesurer des distances directement à l'aide d'ondes ultrasonores avec des équipements et logiciels appropriés. Le dispositif de mesure et de dimensionnement peut être utilisé avec tout dispositif d'imagerie, ou peut être utilisé seul pour l'objectif visé.
PCT/TR2018/050287 2017-06-06 2018-06-06 Dispositif de mesure à mémoire de forme et d'imagerie 3d pour des procédures d'intervention WO2019045663A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2017/08377A TR201708377A2 (tr) 2017-06-06 2017-06-06 Şekil hafızalı boyut ölçme ve ölçülen bölgenin 3-boyutlu şeklinin görüntülenmesi için girişimsel amaçlı cihaz.
TR2017/08377 2017-06-06

Publications (2)

Publication Number Publication Date
WO2019045663A2 true WO2019045663A2 (fr) 2019-03-07
WO2019045663A3 WO2019045663A3 (fr) 2019-05-16

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PCT/TR2018/050287 WO2019045663A2 (fr) 2017-06-06 2018-06-06 Dispositif de mesure à mémoire de forme et d'imagerie 3d pour des procédures d'intervention

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TR (1) TR201708377A2 (fr)
WO (1) WO2019045663A2 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7744620B2 (en) * 2003-07-18 2010-06-29 Intervalve, Inc. Valvuloplasty catheter
US8277395B2 (en) * 2004-09-22 2012-10-02 Boston Scientific Scimed, Inc. Lumen measurement devices and related methods
JP2012505050A (ja) * 2008-10-10 2012-03-01 インターバルブ， インコーポレイテッド 弁形成術用カテーテルおよび方法

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WO2019045663A3 (fr) 2019-05-16
TR201708377A2 (tr) 2018-12-21

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