WO2018214807A1 - Procédé et appareil de retrait pour biopsie de ponction de la prostate - Google Patents

Procédé et appareil de retrait pour biopsie de ponction de la prostate Download PDF

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Publication number
WO2018214807A1
WO2018214807A1 PCT/CN2018/087396 CN2018087396W WO2018214807A1 WO 2018214807 A1 WO2018214807 A1 WO 2018214807A1 CN 2018087396 W CN2018087396 W CN 2018087396W WO 2018214807 A1 WO2018214807 A1 WO 2018214807A1
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WO
WIPO (PCT)
Prior art keywords
puncture
coordinate system
point
target
prostate
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Application number
PCT/CN2018/087396
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English (en)
Chinese (zh)
Inventor
叶慧
Original Assignee
北京龙慧珩医疗科技发展有限公司
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Application filed by 北京龙慧珩医疗科技发展有限公司 filed Critical 北京龙慧珩医疗科技发展有限公司
Publication of WO2018214807A1 publication Critical patent/WO2018214807A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0241—Pointed or sharp biopsy instruments for prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound

Definitions

  • the invention belongs to the field of medical instruments, and particularly relates to a local puncture method for prostate lesion tissue and a calculation method for the spatial position of the preoperative puncture needle.
  • Prostate cancer is one of the most common cancers in the male population, and its mortality rate ranks second in non-skin cancer.
  • the most popular prostate cancer screening method is serum prostate specific antigen screening, followed by six or more biopsies performed in real-time 2D transrectal ultrasound guidance. As part of this procedure, the prostate is typically divided into six equal volume regions. One or more biopsies are taken from each of these six regions in a systematic, but essentially non-directional manner. This procedure is called a sextant biopsy.
  • the sextant biopsy is low cost and relatively simple compared to other methods of detecting prostate cancer, it is widely used.
  • the sextant biopsy has shown a severe false negative rate and may be inaccurate with regard to the true location of the biopsy.
  • the results of the sextant biopsy are usually reported using the original standard map of the prostate, and the pathologist manually annotates the biopsy results on the original standard map of the prostate. This picture is intrinsically inaccurate because the pathologist who annotated does not know the real part of the biopsy.
  • Transrectal ultrasound (TRUS)-guided systemic biopsy seems to solve the above technical problems. Because of its real-time performance, imaging without radiation, low cost and simple operation, it has become an important indicator for the diagnosis and diagnosis of prostate cancer.
  • ultrasound imaging is fast, although it can be imaged in real time during surgery.
  • the discrimination between soft tissues in the image is not high.
  • the position of the sampling catheter can be tracked in real time, the lesion cannot be imaged. Accurate positioning of the tissue results in a pure ultrasound-based sampling method that is not sensitive to cancer detection, only 60% to 85%.
  • prostate interventional surgery is performed under 2D transrectal ultrasound guidance, only the prostate tissue contour can be seen without soft tissue. It is not sensitive to chronic prostatitis, prostatic hypertrophy, and early prostate cancer, so the sextant biopsy usually The average sample was taken from the top, middle and bottom of the prostate, and the left and right sides, and the representative samples were taken out. This random biopsy was predicted without accurately grasping the cancer location, and the high detection rate of cancer could not be guaranteed. Most cancers occur in the top region of the prostate. Although the biopsy is guided by the TURS, the needle may not reach the target area accurately. Only the doctor's skill and experience locate the needle, and it is impossible to accurately determine whether it is accurate.
  • a method comprising the steps of:
  • the puncture set having an outer sheath, a puncture needle embedded in the outer sheath, and a hose, the outer edge of the outer sheath being connected to the first edge a position sensor having a handle tail end for the operator to hold and a remote front end contacting the examined portion; a contact force sensor at the remote front end portion, a transmitter, a receiver, and an ultrasound at the remote front end portion a transducer, and a second position sensor located at a rear side of the remote front end;
  • Puncture point delineation pre-acquisition of the medical imaging modality of the subject before surgery, path planning operation according to the imaging modality, and
  • the iterative threshold segmentation combined with morphological operation is used to segment the image of the detected part.
  • the target feature morphology is extracted by the double threshold method in the segmented part of the segment, and then the surface rendering method is used for 3D visualization. Finally, the visual image is imported into 3D.
  • the Slicer selects the first target entry point to the sixth target entry point based on the spatial anatomical positional relationship of the target feature form, thereby taking out the examined tissue A2, A3, A4, A5, A6.
  • the medical imaging modality is one of the following, medical resonance (MR) imaging; computed tomography (CT) imaging; positron emission tomography (PET) imaging; or single photon emission computed tomography (SPECT) imaging.
  • MR medical resonance
  • CT computed tomography
  • PET positron emission tomography
  • SPECT single photon emission computed tomography
  • the medical imaging modal device has a custom coordinate system, which is recorded as the tracking system coordinate system C T in the method , according to the voxel position parameter and the voxel size parameter in the DICOM file of the medical imaging modal image.
  • the layer spacing parameter obtains the coordinate information of the reference point;
  • the calibration container is filled with water or a coupling agent, and the puncture kit is placed on the fixing bracket, attached to one side of the container and fixed, and the ultrasonic image in the calibration container is collected in real time, and the second position sensor is recorded at this time.
  • the metal probe locator is fixed on the probe clamping bracket, and the spatial position of the metal probe locator is moved.
  • the movement stops, and the metal probe locator is fixed, and the metal probe is fixed.
  • the needle tip is located in the ultrasound imaging area, and the coordinate P i of the metal probe locator in the tracking system coordinate system C T is recorded, and the coordinate I i of the bright spot on the ultrasonic image coordinate system Cus is recorded on the ultrasonic image;
  • ICP Iterative Closest
  • CPR coherent point drift
  • RP robust point match
  • an apparatus comprising: a puncture kit, a moving unit, a calibration container, and an information processing unit,
  • the puncture set has an outer sheath, a puncture needle and a hose embedded in the outer sheath, and an outer edge of the outer end of the outer sheath is connected to the first position sensor, and the puncture needle has a handle end end for the operator to hold And a remote front end contacting the examined portion; a contact force sensor at the remote front end portion, a transmitter at the remote front end portion, a receiver and an ultrasonic transducer, and a second side at a rear side of the remote front end portion position sensor;
  • An information processing unit that establishes an ultrasound image in response to the processor and the ultrasound transducer echo signal
  • the moving unit moves the holder in real time in a three-dimensional direction
  • the calibration container is a container that is open at the top.
  • the outer edge of the outer end of the outer sheath is further connected with an angle indicating dial, the angle indicating that the dial is arranged counterclockwise, and the direction of the 0 scale in the dial coincides with the sagittal axis of the human coordinate system.
  • the metal probe locator is composed of a handle, a needle and a positioning sensor, and the tracking system can display the real-time coordinates of the positioning sensor in the tracking system coordinate system in real time.
  • the moving unit is composed of a base and a plurality of rods and a gripper.
  • the rods are connected by a sliding rail, and the slidable and fixed gripper clamps the metal probe locator and can be moved to the target position and fixed. To keep the metal probe positioner down vertical.
  • Figure 1 is a schematic diagram of a six-point sampling of the present invention.
  • FIG. 2 is a schematic view of the schematic device of the angle dial of the present invention.
  • FIG. 3 is a flow chart of a calibration scheme for an ultrasound image and tracking system coordinate system calibration according to the present invention.
  • the invention mainly includes two aspects:
  • the interventional physician passes the rectal puncture kit through the rectum into the prostate, and the ultrasound enters the prostate from the prostate side through the rectal wall, prostate, and rectal interface.
  • the working frequency is usually At around 6.5MHz, because the preoperative doctor has obtained the position of the lesion in the medical imaging modal device, the interventional doctor selects the region of interest for the needle by experience, and divides the traditional whole prostate into six parts (the top of the prostate, The middle and bottom, left and right sides are improved to select punctures only for the lesions of the above-mentioned regions of interest, and select the points in the upper-lower, left-right, anterior-posterior directions of the diseased tissue, as shown in Fig.
  • the puncture needle can only be performed in the rectum, and the puncture kit can only move up and down the rectum. Therefore, if it is necessary to reduce the number of puncture needles entering the prostate and the depth as much as possible, the puncture needs to be performed.
  • the needle advances in the direction of adjustment, that is, the tail end of the hand-held puncture needle handle rotates around the axis of the handle itself, so that The puncture needle achieves six-point sampling by in and out and rotation in the case of a needle insertion to the diseased tissue.
  • the puncture needle handle end of the puncture kit contains a position sensor that provides a signal to a processor located in the console.
  • the processor can perform several processing functions as described below, introducing a contact force sensor and a position sensor in the puncture kit, and an angle indicating dial on the outer edge of the outer end of the outer sheath of the puncture kit.
  • the angle dial design is shown in Figure 2: the direction of the 0 scale in the dial coincides with the sagittal axis of the human coordinate system; the direction of the angle increase is counterclockwise; the hole in the center is the reserved hole for nesting in the puncture kit On the outer sheath.
  • the medical imaging modal device has a custom coordinate system, which is recorded as the tracking system coordinate system C T in the method , according to the voxel position parameter and the voxel size parameter in the DICOM file of the medical imaging modal image.
  • the layer spacing parameter obtains the coordinate information of the reference point;
  • the calibration container (4) is filled with water or a coupling agent, and the puncture kit (9) is placed on the fixing bracket (11), attached to one side of the container (4) and fixed, and the calibration container is collected in real time (4).
  • the ultrasonic image (6) inside, recording the conversion matrix T2 given by the second position sensor (10) at this time;
  • the metal probe positioner 5 (composed of the handle 5-1 and the needle 5-2) is fixed on the probe holding bracket, and the spatial position of the metal probe positioner (5) is moved when the ultrasonic image appears. When the bright spot is stopped, the movement is stopped. At this time, the metal probe positioner is fixed, and the metal probe tip (5-2) is located in the ultrasonic imaging area, and the metal probe positioner (5) is recorded in the tracking system coordinate system C T at this time.
  • ICP Iterative Closest
  • CPR coherent point drift
  • RP robust point match
  • the purpose of the probe holding bracket (1) is to hold the metal probe positioner (5) and to move the metal probe positioner (5) to the target position and fix it.
  • the probe clamping bracket is composed of a base and a bracket rod (1), a crossbar (2), and a longitudinal rod (3).
  • the bracket rod (1), the crossbar (2), and the longitudinal rod (3) are connected by a slide rail. , can be slid and fixed.
  • a clamp is mounted on the longitudinal rod (3) to hold the shank 5-1 of the metal probe positioner (5) so that the needle 5-2 remains vertically downward.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention concerne un procédé et un appareil de retrait permettant de faire fonctionner avec précision une aiguille de ponction de la prostate pour effectuer une biopsie. La biopsie en sextant classique est améliorée, c'est-à-dire qu'il y a une amélioration de la division égale d'une prostate entière en six parties (le haut, le milieu et le bas, et les côtés gauche et droit d'une prostate) avant de sélectionner un point à percer dans une région d'intérêt. Une région de lésion de la prostate claire et stéréoscopique peut être complètement fournie à un médecin au moyen d'informations d'image préopératoire. Au moyen de l'ajout d'un appareil d'aide au cadran d'indication d'ajustement d'angle, et du calcul, sur la base d'une planification préopératoire, d'une position de point d'aiguille, d'un itinéraire planifié et d'un angle de rotation de ponction requis, un kit de ponction amélioré (9) peut réaliser une opération de rotation précise, a une précision supérieure et une spécificité individuelle élevée, et réalise une ponction précise.
PCT/CN2018/087396 2017-05-26 2018-05-17 Procédé et appareil de retrait pour biopsie de ponction de la prostate WO2018214807A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201710378802.X 2017-05-26
CN201710378802.XA CN107049371B (zh) 2017-05-26 2017-05-26 一种前列腺穿刺术活检取出方法及装置

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WO2018214807A1 true WO2018214807A1 (fr) 2018-11-29

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107049371B (zh) * 2017-05-26 2019-08-13 北京龙慧珩医疗科技发展有限公司 一种前列腺穿刺术活检取出方法及装置
CN109758213B (zh) * 2019-01-11 2020-09-08 北京大学第一医院 一种磁共振-超声融合前列腺穿刺针定位方法及系统

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4742829A (en) * 1986-08-11 1988-05-10 General Electric Company Intracavitary ultrasound and biopsy probe for transvaginal imaging
CN102056559A (zh) * 2008-06-12 2011-05-11 皇家飞利浦电子股份有限公司 具有声学元件的活检设备
US20120010512A1 (en) * 2010-07-12 2012-01-12 O'laughlin Michael Scanning Probe
CN203338648U (zh) * 2013-05-20 2013-12-11 浙江大学 一种超声引导针穿刺手术模拟训练系统
CN105188560A (zh) * 2012-12-11 2015-12-23 生物机器人医疗有限公司 用于活检和治疗的器械及方法
CN205924126U (zh) * 2016-06-26 2017-02-08 袁征 一种超声介入可视化引导装置
CN107049371A (zh) * 2017-05-26 2017-08-18 北京龙慧珩医疗科技发展有限公司 一种前列腺穿刺术活检取出方法及装置

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4742829A (en) * 1986-08-11 1988-05-10 General Electric Company Intracavitary ultrasound and biopsy probe for transvaginal imaging
CN102056559A (zh) * 2008-06-12 2011-05-11 皇家飞利浦电子股份有限公司 具有声学元件的活检设备
US20120010512A1 (en) * 2010-07-12 2012-01-12 O'laughlin Michael Scanning Probe
CN105188560A (zh) * 2012-12-11 2015-12-23 生物机器人医疗有限公司 用于活检和治疗的器械及方法
CN203338648U (zh) * 2013-05-20 2013-12-11 浙江大学 一种超声引导针穿刺手术模拟训练系统
CN205924126U (zh) * 2016-06-26 2017-02-08 袁征 一种超声介入可视化引导装置
CN107049371A (zh) * 2017-05-26 2017-08-18 北京龙慧珩医疗科技发展有限公司 一种前列腺穿刺术活检取出方法及装置

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