WO2018214805A1

WO2018214805A1 - Prostate puncture kit

Info

Publication number: WO2018214805A1
Application number: PCT/CN2018/087394
Authority: WO
Inventors: 叶慧
Original assignee: 北京龙慧珩医疗科技发展有限公司
Priority date: 2017-05-26
Filing date: 2018-05-17
Publication date: 2018-11-29
Also published as: CN107049370B; CN107049370A

Abstract

Disclosed is a prostate puncture kit (41). A high-precision electromagnetic positioner is used to track an ultrasonic transducer (45) and a puncture needle (40) in real time to guide prostate puncturing. The kit (41) is a flexible cylindrical pipeline. If no force exists on a tail end (47) of the pipeline or if the force is parallel to a far-side end portion axis (46), a far-side end portion and a near-side end portion of a connection part of the flexible cylindrical pipeline align, and the far-side end portion axis (46) aligns with an axis (52) of a far-side portion of the flexible cylindrical pipeline. On the contrary, if an asymmetric force exists on the tail end, these two axes do not align. Once the axes align, the ultrasonic transducer (45) can carry out an operation, and tension on a contact force sensor (43) can be read so as to establish a tissue structure and create a contact force. Thus, the prostate puncture kit is used for accurately determining a spatial position of the puncture needle, and provides higher-quality targeted guided puncture by means of multi-modal medical image registration and fusion techniques, in combination with the diagnostic advantage of a preoperative MRI image and the real-time guide advantage of a TRUS image.

Description

Prostate puncture kit

Technical field

The invention belongs to the field of medical instruments, and in particular relates to a prostate puncture kit.

Background technique

Prostate cancer is one of the most common cancers in the male population, and its mortality rate ranks second in non-skin cancer. Currently, 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.

Because the sextant biopsy is low cost and relatively simple compared to other methods of detecting prostate cancer, it is widely used. However, 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. However, ultrasound imaging is fast, although it can be imaged in real time during surgery. However, due to the limited resolution of the ultrasound image, the discrimination between soft tissues in the image is not high. Although 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%.

Summary of the invention

It is an object of the present invention to utilize a high precision electromagnetic locator to track ultrasound transducers and puncture needles to guide prostate puncture in real time and to provide a kit for prostate puncture. The principle of operation is that the kit is a flexible cylindrical tube, and if there is no force on the end of the tube or if the force is parallel to the distal end axis, the distal end and the proximal end of the connecting portion of the flexible cylindrical tube are aligned And the distal tip axis is aligned with the axis of the distal portion of the flexible cylindrical conduit; conversely, if there is an asymmetrical force on the tip, the two axes are misaligned.

In accordance with the physical model described above, in all cases, the orientation of the ultrasound transducer in the kit for prostate puncture and the beam emitted by the ultrasound transducer can be calculated; and the alignment or misalignment of the two axes can be determined. Once the axis is aligned, the ultrasonic transducer can be operated and the tension on the contact force sensor can be read to establish the tissue structure and contact force, thereby being used to accurately determine the spatial position of the puncture needle, through multimodality Medical image registration and fusion techniques combine the diagnostic advantages of preoperative MRI images with the real-time guidance advantages of TRUS images to provide higher quality targeted guided punctures. The method is mainly directed to the following technical problems existing in the prior art:

Prostate MRI-TRUS images require a lot of time for the MRI and the clinician to register for prostate MRI and ultrasound images, large deformation of the prostate by probe extrusion, and fewer features for registration in ultrasound images. The TRUS data is manually segmented, and the instability of the segmentation result has a great influence on the registration effect. The clinically practical one is the electromagnetic target-based prostate-targeted puncture system proposed by Xu S, Kruecker J. Preoperative MRI and 3D TRUS images were manually rigid-body registration, and then the two-dimensional and three-dimensional transrectal ultrasound images were registered by electromagnetic positioning technique during the puncture. Finally, the intraoperative two-dimensional ultrasound images were calculated based on the preoperative rigid body registration results. The spatial transformation relationship of preoperative MRI images, however, the 3D TRUS data used in the system is reconstructed based on the electromagnetic positioning sensor attached to the ultrasonic probe and a series of two-dimensional image data, which is computationally intensive and long in scanning time. Reconstruction of the scanning process probe is easy to cause different degrees of compression on the prostate, affecting the accuracy of reconstruction.

The invention accurately positions the ultrasonic probe and the puncture needle by means of the electromagnetic locator, and uses the MRI and 3D TRUS manual rigid body registration to utilize the high specificity of the MRI image for early prostate cancer, and accurately selects the localized puncture area as the perceptual interest area. Selective needle biopsy is different from previous sextant biopsy. The sextant biopsy is usually divided into six parts from the top, middle and bottom of the prostate, and the left and right sides. The representative sample is taken out. This random biopsy is in The predictions made when the cancer position is not accurately grasped cannot guarantee the high detection rate of cancer. The puncture method of selecting only the region of interest of the present invention can provide the doctor with a clear and stereoscopic prostate through the preoperative image information. The lesion area, thereby improving the detection rate of prostate cancer, and the prostate puncture kit proposed by the present invention solves the problem that the conventional image reconstruction method is computationally intensive, takes a long time, and is caused by the ultrasonic probe to squeeze the prostate during the reconstruction scan. The difference in deformation leads to shortcomings such as low reconstruction accuracy and improves the accuracy of the three-dimensional data.

The technical solution of the present invention is:

Inserting the puncture kit into a cavity in the body of the subject, 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;

Operating the puncture needle into contact with a target detection point located in a wall of the chamber;

Establishing a desired contact force between the front end of the puncture needle distal front end and the target exit pin point in response to the reading of the contact force sensor;

The position and orientation of the second position sensor is sensed according to an electromagnetic locator that utilizes a coil that generates a magnetic field to generate a magnetic field at a predetermined working volume and sense the signal.

Further, the second position sensor comprises a spring in the form of a double helix disposed in the rear side of the distal front end and proximal to the contact force sensor; the proximal portion of the contact force sensor is disposed about the longitudinal axis.

Further, when there is no force in the spring or if the force is parallel to the axis of symmetry, the distal end and the proximal end of the spring are aligned, and the axis of symmetry is aligned with the longitudinal axis of the distal portion of the hose; There is an asymmetrical force, the two axes are misaligned; the orientation of the ultrasonic transducer and the beam emitted by the ultrasonic transducer is calculated based on the change signal of the spring in the magnetic field; and the alignment or misalignment of the two axes is determined quasi.

Further, the processor can determine an angular deflection of the distal front end relative to the proximal portion whereby the contact force and the amount of misalignment with the proximal portion can be calculated.

Further, the processor directly derives the three-dimensional orientation of the ultrasound transducer and thereby derives the direction of the beam emitted by the ultrasound transducer; the ultrasound transducer direction can be improved by calibrating the beam relative to the second position sensor orientation .

Further, the receiver in the remote front end portion is a set of three coils; the three coils generate a force dependent signal based on incident radiation generated by the transmitter; analysis of the force dependent signal The orientation of the distal end relative to the axis of the proximal end of the spring in the contact force sensor, ie the amount of bending of the helical spring, is given.

As another embodiment of the present invention, the present invention further provides an apparatus, comprising: a puncture kit, an electromagnetic locator, 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;

Establishing, in response to the reading of the contact force sensor, a processor that establishes a desired contact force between the front end of the puncture needle distal front end and the target exit pin point;

An information processing unit that establishes an ultrasound image in response to the processor and the ultrasound transducer echo signal,

The electromagnetic locator senses a position and an orientation of a second position sensor that utilizes a coil that generates a magnetic field to generate a magnetic field at a predetermined working volume and sense the signal;

Further, the processor derives acoustic pulses emitted by the ultrasonic transducer via the receiver and improves the ultrasonic transducer orientation by calibrating the beam relative to the position sensor orientation.

DRAWINGS

The drawings described herein are intended to provide a further understanding of the invention, and are intended to be a part of the invention. In the drawing:

1 is a system for treating tissue using a puncture kit in accordance with an embodiment of the present invention.

2 is a graphical illustration of a remote front end of a puncture kit in an operational position in accordance with an embodiment of the present invention.

3 is a partial elevational view of the distal front end of a puncture kit in accordance with an embodiment of the present invention.

4 is a graphical illustration of a receiver in accordance with an embodiment of the present invention.

detailed description

The invention will be described in detail below with reference to the drawings in conjunction with the embodiments.

The improvements made by the present invention in terms of a puncture kit with an ultrasonic transducer mainly include two aspects.

Puncture kit structure improvement

Analysis of surgical procedures:

During the operation, the patient lies flat, 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. In order to ensure the penetration of the ultrasonic signal, 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. 1. Because the rectum and the prostate are disconnected organs, 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 In the case where the lancet diseased tissue into a six-point sampling needle and out through rotation.

Puncture kit improvements:

To assist the physician in operation, the puncture needle handle end of the puncture kit contains a position sensor that provides a signal to a processor located in the console. 1 shows a basic block diagram of an ultrasound therapy system utilizing a puncture kit in accordance with one embodiment of the present invention. In this embodiment, the patient treatment device includes both an ultrasound transducer 45 and an ultrasound imaging transducer. The two transducers can be separate devices or can be a one-piece device in which high intensity focused ultrasound and imaging ultrasound elements are shown on the same transducer head. Controlling the operation of imaging and ultrasound transducer 45 is system controller 113, which may include one or more processors having general purpose or special purpose programs to perform the functions described above. The system controller 113 provides a control signal to the transmitter 48 that selects the frequency of the ultrasonic signal provided by the ultrasonic transducer 45. In one embodiment, the operational power level is selected by transmitting a plurality of test signals of different power levels and parsing the echo signals generated by the transmitted test signals. When a desired characteristic of the echo signal is observed, such as when a particular power distribution on a different fundamental frequency and resonance component is detected within the echo signal, the ultrasonic diagnostic power level for the particular examined site is selected.

Imaging transducer 108 is controlled by imaging ultrasound controller 110, which includes conventional ultrasound components, such as transmit/receive switches, beamformers, radio frequency amplifiers, and signal processors. The output of the ultrasound controller 110 is fed back to the ultrasound signal processor 111 to generate an ultrasound image signal for display on the video monitor 112 or other display device. The image signals may be stored in a computer readable medium (DVD, videotape, etc.), printed by a printer, or otherwise stored for subsequent diagnosis or analysis.

The second position sensor 50 (or computer controlled steering) is controlled by the system controller 113 to generate a plurality of regions of interest for biopsy of the tissue. In one embodiment, the second position sensor 50 mechanically adjusts the angular orientation or x, y position of the ultrasonic transducer 45 as well as the depth of focus. In another embodiment, the second position sensor 50 electrically adjusts the angular orientation or x, y position of the focal region of the ultrasonic transducer 45 and the depth of the focal region of the ultrasonic transducer 45.

With the foot switch 115, the physician or his assistant can selectively deliver ultrasonic energy to the ultrasonic transducer 45. Additionally, the physician can manually change the size and shape of the region of interest and other functions of the system using one or more control buttons on the control panel 114.

In some embodiments, the system can include an image position controller 109 that changes the orientation of the imaging transducer 108 to enable the physician to view the target puncture tissue at different angles or on different planes. Image position control can be mechanical or electric and can be controlled by system controller 113.

Reference is now made to Fig. 2, which is a graphical illustration of the end of a puncture set 41, shown in an operative position, in accordance with an embodiment of the present invention. The puncture needle 40 is pushed into contact with the rectal diaphragm 105. However, the contact force is asymmetrical, thereby causing the spring 51 of the contact force sensor 43 to flex. The site to be examined 47 does not abut the rectal membrane 105, but forms an angle 106 with the rectal membrane 105. The axis of symmetry 461 and longitudinal axis 52 are not aligned, but intersect at an angle 107.

The distal end of the puncture set 41 contacting the examined portion 47 is shown in Figure 3: a contact force sensor 43 at the remote front end portion 42, a transmitter 48 at the remote front end portion 42, a receiver 44, and an ultrasonic transducer And a second position sensor 50 located at the rear side 49 of the remote front end;

A processor (not shown) that establishes a desired contact force between the distal front end 42 of the puncture needle 40 and the target exit pin point in response to the reading of the contact force sensor 43;

An information processing unit that establishes an ultrasound image in response to the processor and the ultrasound transducer 45 echo signal,

The electromagnetic locator senses the position and orientation of the second position sensor 50, which utilizes a coil that generates a magnetic field to generate a magnetic field at a predetermined working volume and sense the signal;

The operator can adjust the tail of the handle by observing the data given by the processor of the console in response to the sensing signal described above, in conjunction with the signal processing circuit by accepting, amplifying, filtering and digitizing the signal from the first position sensor.

The second position sensor 50, including a spring 51 in the form of a double helix, is disposed in the rear side 49 of the distal front end and proximal to the contact force sensor 43. The proximal portion 49 of the contact force sensor 43 is disposed about the longitudinal axis 52. When the spring 51 flexes, the longitudinal axis 52 need not be aligned with the axis of symmetry 46. In other words, the contact force sensor 53 serves as a joint between the end 41 and the segment proximal to the contact force sensor 43. If there is no force on the tip 47 or if the force is parallel to the axis of symmetry 46, the distal end and the proximal end of the spring 51 are aligned, and the axis of symmetry 46 is with the distal portion of the catheter (located near the contact force sensor 43) The longitudinal axes 52 of the sides are aligned. If there is an asymmetrical force on the end 47, the two axes are misaligned. In all cases, the orientation of the ultrasound transducer 45 and the beam emitted by the ultrasound transducer 45 can be calculated; and the alignment or misalignment of the two axes can be determined.

Further, including

The processor activates the ultrasonic transducer 45 to derive a three-dimensional orientation of the ultrasonic transducer 45 via a cable 48 at the remote front end via a cable to the console, and thereby derives the ultrasonic transduction The direction of the beam emitted by the device 45. Further, including

The processor derives acoustic pulses emitted by the ultrasonic transducer 45 via the receiver 44 and improves the ultrasonic transducer 45 direction by aligning the beam with respect to the orientation of the second position sensor 50.

As shown in the receiver 10 of Figure 4, the receiver 10 preferably includes two or more and more preferably three

sensor coils

101, 102, 103 wound on an air core. The coils have axes that are orthogonal to each other. The coil 102 is conveniently aligned with the long axis of the catheter. The

coils

101, 102, 103 are closely spaced along the axis of the catheter to reduce the diameter of the second position sensor and thereby make the sensor suitable for engagement into the remote front end.

For most applications, quantitative measurements of the position and orientation of the distal end of the catheter relative to the reference frame are necessary. This requires at least two non-overlapping radiators that generate at least two resolvable AC magnetic fields whose respective positions and orientations relative to the frame of reference are known; radiator drivers, which are preferably used The AC is continuously supplied with an AC signal to generate an AC magnetic field; and a position sensor includes at least two non-parallel sensors to measure magnetic field flux caused by the at least two resolvable magnetic fields. The number of radiators multiplied by the number of sensors is equal to or greater than the number of degrees of freedom of the desired quantitative measurement of the position and orientation of the sensor relative to the frame of reference. At least two coils are required in the receiver 10 when it is desired to determine the six positions and orientation coordinates of the distal tip of the catheter. Three coils are preferably used to improve the accuracy and reliability of the position measurement. In some applications where less dimension is required, only a single coil may be needed in the receiver 10 that is oriented orthogonal to the emitter's dipole emission axis.

Leads 104 are used to transmit signals detected by

sensor coils

101, 102, 103 to the signal processor via the proximal end of the catheter for processing to produce the desired positional information. Preferably, the leads 104 are twisted pairs to reduce pick up and can be further electrically shielded.

The above description is only the preferred embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes can be made to the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and scope of the present invention are intended to be included within the scope of the present invention.

Claims

A method comprising the steps of:

Inserting the puncture kit into a cavity in the body of the subject, 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;

Operating the puncture needle into contact with a target detection point located in a wall of the chamber;

Establishing a desired contact force between the front end of the puncture needle distal front end and the target exit pin point in response to the reading of the contact force sensor;

The position and orientation of the second position sensor is sensed according to an electromagnetic locator that utilizes a coil that generates a magnetic field to generate a magnetic field at a predetermined working volume and sense the signal.
The method of claim 1 wherein said second position sensor comprises a spring in the form of a double helix disposed in the rear side of the distal front end and proximal to the contact force sensor; the proximal portion of the contact force sensor surrounds the longitudinal direction The axis is set.
The method of claim 2 including:

When the spring does not have a force or if the force is parallel to the axis of symmetry, the distal end and the proximal end of the spring are aligned and the axis of symmetry is aligned with the longitudinal axis of the distal portion of the hose; if there is an asymmetry on the spring Force, then the two axes are misaligned; the orientation of the ultrasonic transducer and the beam emitted by the ultrasonic transducer is calculated based on the change signal of the spring in the magnetic field; and the alignment or misalignment of the two axes is determined.
The method of claim 3 including

The processor is capable of determining an angular deflection of the distal front end relative to the proximal portion whereby the contact force and the amount of misalignment with the proximal portion can be calculated.
The method of claim 4 including

The processor directly derives the three-dimensional orientation of the ultrasound transducer and thereby derives the direction of the beam emitted by the ultrasound transducer; the ultrasound transducer orientation can be improved by calibrating the beam relative to the second position sensor orientation.
The method of claim 5 including

The receiver in the remote front end portion is a set of three coils; the three coils generate a force dependent signal based on incident radiation generated by the transmitter; the analysis of the force dependent signal gives a far The orientation of the side end relative to the axis of the proximal end of the spring in the contact force sensor, ie the amount of bending of the coil spring.
An apparatus comprising: a puncture kit, an electromagnetic locator, 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;

Establishing, in response to the reading of the contact force sensor, a processor that establishes a desired contact force between the front end of the puncture needle distal front end and the target exit pin point;

An information processing unit that establishes an ultrasound image in response to the processor and the ultrasound transducer echo signal,

The electromagnetic locator senses a position and an orientation of a second position sensor that utilizes a coil that generates a magnetic field to generate a magnetic field at a predetermined working volume and sense the signal;
The device according to claim 7, wherein

The second position sensor includes a spring in the form of a double helix disposed in a rear side of the distal front end and a proximal side of the contact force sensor; a proximal portion of the contact force sensor is disposed about the longitudinal axis.
The device of claim 8 including

The receiver in the remote front end portion is a set of three coils; the three coils generate a force dependent signal based on incident radiation generated by the transmitter; the analysis of the force dependent signal gives a far The orientation of the side end relative to the axis of the proximal end of the spring in the contact force sensor, ie the amount of bending of the coil spring.
The device of claim 9 further comprising

The processor derives acoustic pulses emitted by the ultrasonic transducer via the receiver and improves the ultrasonic transducer direction by calibrating the beam relative to the position sensor orientation.