CN108283757B

CN108283757B - Interventional catheter, guiding head of interventional catheter, interventional system and interventional method

Info

Publication number: CN108283757B
Application number: CN201810054630.5A
Authority: CN
Inventors: 陈刚; 佟留住; 房文慧
Original assignee: Wuhan United Imaging Zhirong Medical Technology Co Ltd
Current assignee: Wuhan United Imaging Zhirong Medical Technology Co Ltd
Priority date: 2018-01-19
Filing date: 2018-01-19
Publication date: 2020-11-13
Anticipated expiration: 2038-01-19
Also published as: CN108283757A

Abstract

The application relates to the technical field of medical equipment, especially, relate to a guide head of intervene pipe, the guide head has free end and link, the free end is used for the guide head turns to, the guide head includes: an inner tube having a hollow interior; the outer pipe is sleeved outside the inner pipe, and an annular chamber is formed between the inner pipe and the outer pipe; the driving device is arranged in the annular chamber and used for driving the guide head to deform; and the pressure sensor is arranged on the free end and used for sensing the resistance born by the free end in real time. The shape, the corner and the like of the free end of the guide head can be autonomously controlled through the driving device, and the guide is accurately and effectively guided to be intervened in a target vessel or a target tube cavity corresponding to the guide, the resistance to the guide head can be accurately acquired through the pressure sensor positioned on the guide head, and then the traction force of the guide tube is effectively controlled to be intervened, so that the damage to the tube cavity through which the guide head passes due to overlarge guide force is avoided, and the risk of causing many complications is reduced.

Description

Interventional catheter, guiding head of interventional catheter, interventional system and interventional method

Technical Field

The invention relates to the technical field of medical instruments, in particular to an interventional catheter, a guide head of the interventional catheter, an interventional system and a method.

Background

In clinical intervention for a patient through a lumen (including a blood vessel and a lumen), a physician is generally required to manually rotate and push and pull a guide wire under continuous exposure based on Digital Subtraction Angiography (DSA) to guide a catheter into a target region (such as a target blood vessel or a target lumen).

However, in the actual operation process, the resistance condition of the guide head of the catheter is sensed manually and the guide head is controlled to turn, so that the interventional catheter can be implanted into the target region only by repeating multiple operations, and particularly when the interventional catheter is implanted into a complicated lumen, the lumen through which the interventional catheter passes is damaged even due to the overlarge guiding force of the guide head, so that many complications are caused.

Disclosure of Invention

Therefore, it is necessary to provide an interventional catheter, a guiding head of an interventional catheter, an interventional system and a method for solving the above technical problems, wherein the shape, the rotation angle and the like of the free end of the guiding head can be automatically controlled through a driver electrode, the interventional catheter can be accurately and effectively guided to enter a corresponding target blood vessel or a target cavity channel, the resistance borne by the current guiding head can be accurately acquired through a piezoelectric sensor positioned on the guiding head, so that the traction force of the interventional catheter can be effectively controlled, the damage to a lumen through which the guiding head passes due to overlarge guiding force can be avoided, and the risk of causing many complications can be reduced.

An introducer head for an interventional catheter, the introducer head having a free end and a connected end, the free end for guiding the introducer head for steering or/and monitoring, the introducer head comprising:

an inner tube having a hollow interior;

the outer pipe is sleeved outside the inner pipe, and an annular chamber is formed between the inner pipe and the outer pipe;

the driving device is arranged in the annular chamber and used for driving the guide head to deform; and

and the pressure sensor is arranged on the free end and used for sensing the resistance born by the free end in real time.

Foretell guide head of interveneeing pipe can order about the guide head automatically through utilizing drive arrangement and take place the deformation, and then make the guide head realize accurate corner and turn to and accurate effectual guide intervenes the pipe and gets into the lumen that corresponds (target blood vessel or target chamber say) in time, and pressure sensor then can feed back the resistance value that the free end sensed to the control end in real time, and then the traction force of effectual control intervenes the pipe, in order to avoid because of guide dynamics is too big and to the damage that the lumen that it passed through caused, reduce the risk that causes a great deal of complications.

In an alternative embodiment, the drive means is an ionic drive;

the ionic driver is arranged in the annular chamber along the length direction of the guide head and used for changing the rotating angle of the free end by driving the guide head to deform.

In an alternative embodiment, the ionic driver is a carbon nanotube graphene ionic driver;

the carbon nanotube graphene ionic driver is respectively connected with the inner tube and the outer tube so as to drive the guide head to deform by changing the shape of the inner tube and/or the outer tube.

In an alternative embodiment, the pressure sensor is a piezoelectric film sensor;

the piezoelectric film sensor is respectively connected with the inner tube and the outer tube and used as a supporting structure of the guide head.

In an optional embodiment, the carbon nanotube graphene ionic driver and the piezoelectric thin film sensor are alternately distributed in the annular chamber.

An interventional catheter may include:

a guide head as claimed in any preceding claim;

a catheter body having a free connection end and a connection terminal;

the free connection end is connected with the free end of the guide head in a penetrating mode, and the connection terminal is used for being connected with an external control device.

Foretell intervene pipe can order about the guide head automatically through the drive arrangement who utilizes to intervene in the pipe and take place the deformation, and then make the guide head realize accurate corner and turn to and accurate effectual guide intervenes the pipe and gets into the lumen that corresponds (being target blood vessel or target chamber way) in time, and intervene pressure sensor in the pipe then can feed back the resistance value that the free end sensed to the control end in real time, and then the traction force of effectual control intervene pipe, in order to avoid because of guide too big and to the damage that the lumen that it passed through caused, reduce the risk that causes a great deal of complication.

In an alternative embodiment, the catheter body has an inner bore in communication with the inner tube; and

the connecting terminal of the catheter body is provided with an electrode interface array which is embedded into the inner wall of the catheter body and is respectively connected with the driving device and the pressure sensor.

In an alternative embodiment, the end of the catheter body connection terminal is provided with angular reference markings for positional calibration of the guide head.

An interventional system may include:

an interventional catheter as in any one of the above;

the medical imaging equipment is used for acquiring medical images of a patient in real time;

and the propelling device is connected with the connecting terminal of the catheter body and is used for controlling the interventional catheter to carry out interventional therapy on the patient according to the medical image.

Foretell intervention system, through utilizing the intervention pipe that embeds there is drive arrangement, can order about automatically that the guide head takes place deformation, and then make the guide head realize accurate corner turn to, and accurate effectual guide in time intervenes the pipe and gets into the lumen that corresponds (being target blood vessel or target chamber way), and intervene pressure sensor among the pipe and then can feed back the resistance value that the free end sensed to the control end in real time, and then the traction force of effectual control intervention pipe, in order to avoid because of guide too big and to the damage that the lumen that it passed through caused, reduce the risk that causes a great deal of complication.

An interventional method, which can be based on the interventional system, includes:

acquiring a tomographic image sequence of a patient by using a medical imaging device;

reconstructing and acquiring a three-dimensional image of the lumen based on the tomographic image sequence;

simulating virtual cavity space of each cavity based on the tomographic image sequence;

acquiring starting point information and end point information of interventional operation on the lumen three-dimensional image;

generating navigation information of intervention operation according to the virtual cavity space of each cavity based on the starting point information and the end point information;

and performing intra-luminal guidance on the interventional catheter based on the navigation information.

The interventional method is based on the interventional system in the embodiment, the lumen three-dimensional image is performed by using the tomographic image sequence to generate the navigation information, the interventional catheter with the built-in driving device is used for automatically driving the guide head to deform based on the navigation information, so that the guide head can realize accurate corner steering, and accurately and effectively guide the interventional catheter to enter the corresponding lumen (namely a target blood vessel or a target lumen channel), and meanwhile, the resistance value sensed by the free end can be fed back to the control end in real time by using the pressure sensor in the interventional catheter, so that the traction force of the interventional catheter can be effectively controlled, the damage to the lumen through which the interventional catheter passes due to overlarge guiding force can be avoided, and the risk of causing various complications can be reduced.

Drawings

FIG. 1 is a schematic view of the structure of a guiding head of an interventional catheter in one embodiment;

FIG. 2a is a schematic view of the guide head shown in FIG. 1 when bent to the left;

FIG. 2b is a schematic view of the guide head shown in FIG. 1 shown in an unbent configuration;

FIG. 2c is a schematic view of the guide head shown in FIG. 1 in a right-side bent configuration;

FIG. 3a is a schematic cross-sectional view of the drive arrangement in the guide head shown in FIG. 1;

FIG. 3b is a schematic top view of the guide head shown in FIG. 1;

FIG. 3c is a schematic cross-sectional view of a pressure sensor in the lead head shown in FIG. 1;

FIG. 4 is a schematic structural diagram of an interventional catheter in one embodiment;

FIG. 5a is a cross-sectional view of the connecting end of the interventional catheter shown in FIG. 4;

FIG. 5b is a perspective view of the connecting end of the interventional catheter shown in FIG. 4;

FIG. 5c is a cross-sectional view of the interventional catheter connection end interface array shown in FIG. 4;

FIG. 6a is a schematic diagram of an interventional system including a CT device in one embodiment;

fig. 6b is a schematic structural diagram of an interventional system incorporating a DSA device in one embodiment;

fig. 6c is a schematic structural diagram of an interventional system including a CT device and a DSA device in one embodiment;

FIG. 6d is a schematic representation of an interventional system incorporating an MRI apparatus according to one embodiment;

FIG. 7a is a schematic illustration of a sequence of images in one embodiment;

FIG. 7b is a schematic illustration of a three-dimensional reconstructed image in one embodiment;

FIG. 7c is a schematic illustration of a virtual channel in one embodiment;

FIG. 7d is a schematic representation of a sequence of images based on a spatial coordinate system in one embodiment;

FIG. 7e is a schematic illustration of extracting lumen location information in one embodiment;

FIG. 7f is a diagram of extracting lumen property parameters, in one embodiment;

FIG. 7g is a diagram illustrating extraction of start point information and end point information for a three-dimensional image, according to one embodiment;

FIG. 7h is a schematic illustration of a navigation trajectory in one embodiment;

FIG. 8 is a flow diagram illustrating an interventional method in one embodiment.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

FIG. 1 is a schematic diagram of the structure of a guiding head of an interventional catheter in one embodiment. As shown in fig. 1, a guiding head 1 of an interventional catheter, the guiding head 1 having a free end for guiding the guiding head to turn and a connection end for connecting with a body of the interventional catheter, the guiding head 1 may include an inner tube 11, an outer tube 12, a driving device (e.g., a carbon nanotube graphene ionic driver 13) and a pressure sensor (e.g., a piezoelectric thin film sensor 14). Wherein, the inner tube 11 is provided with a hollow inner cavity 15 for delivering liquid medicine; the outer tube 12 is sleeved outside the inner tube 11 for insulation protection, and an annular chamber (not shown in the figure) is formed between the inner tube 11 and the outer tube 12; the driving device is arranged in the annular cavity and used for driving the guide head 1 to deform so as to realize steering; the free end region of the guide head 1 is provided with a sensor. Alternatively, the sensor may be configured as a pressure sensor, a resistance sensor, a force sensor, etc. for sensing in real time the resistance experienced by the free end or the entire guide head 1 during the interventional procedure, or sensing the resistance experienced by the free end or the entire guide head 1 during the interventional procedure and converting the resistance into a parameter such as a resistance value.

Further, the driving device may be an ionic driver, which may be disposed in the annular chamber between the inner tube 11 and the outer tube 12 along the length direction of the guide head 1, so as to facilitate driving the guide head 1 to deform and further change the rotation angle of the free end of the guide head 1 and change the steering or/and monitoring operation.

Fig. 2a is a schematic perspective view of the guide head shown in fig. 1 when bent to the left, fig. 2b is a schematic perspective view of the guide head shown in fig. 1 when not bent, and fig. 2c is a schematic perspective view of the guide head shown in fig. 1 when bent to the right. As shown in fig. 2a to 2c, the above-mentioned guiding head 1 can be used in the process of performing an intervention operation on a lumen (such as a blood vessel and/or a lumen), when the carbon nanotube graphene ionic driver 13 is selected as a driving device, that is, the carbon nanotube graphene ionic driver 13 can fill a part of the annular inner cavity, so that the carbon nanotube graphene ionic driver 13 is respectively in contact with the inner tube 11 and the outer tube 12, and then the shape of the inner tube 11 and/or the outer tube 12 is changed to drive the guiding head 1 to deform, thereby realizing a turning angle and a steering direction. For example, when the carbon nanotube graphene ionic driver 13 is not operated, the free end 16 of the lead 1 is initially in a straight state (as shown in fig. 2 b), and when the carbon nanotube graphene ionic driver 13 is operated, i.e., under the action of the driver voltage, the free end 16 of the lead 1 can be driven to bend to the left (as shown in fig. 2 a) or to the right (as shown in fig. 2 c).

In an alternative embodiment, the introducer head has a free end that is bendable and a connecting end that is connectable to the catheter body. Wherein, the free end can include: an inner tube having a hollow interior; the sensors are arranged on the outer side of the inner pipe and used for sensing and acquiring pressure signals of the free end, and the sensors are sequentially distributed along the length direction of the inner pipe; a plurality of driving devices disposed outside the inner tube, the plurality of driving devices being adjacent to the plurality of sensors; the controller is electrically connected with the sensors and the driving devices respectively, and can generate control signals according to the pressure signals, and the control signals are used for controlling the driving devices so as to drive the inner pipe to deform. In this embodiment, at least one of the plurality of driving means comprises an inner driving electrode and an outer driving electrode, which are capable of generating different voltage values under the control signal, thereby causing the driving means to be capable of contracting in the left, right, or any direction to cause the inner tube to bend in a specific direction. For example, when the control signal controls the left outer layer driving electrode in the driving device to be a positive voltage, the left inner layer driving electrode is a negative voltage; the control signal controls the right outer layer driving electrode in the driving device to be positive voltage, the right inner layer driving electrode is negative voltage, and the left outer layer driving electrode is positive voltage which is larger than the right outer layer driving electrode, so that the driving device rotates rightwards and drives the inner pipe to rotate rightwards. Similarly, when the positive voltage of the left outer layer driving electrode is smaller than that of the right outer layer driving electrode, the driving device rotates leftwards and drives the inner pipe to rotate leftwards.

Fig. 3a is a schematic cross-sectional view of a driving device in the guide head shown in fig. 1, fig. 3b is a schematic top view of the guide head shown in fig. 1, and fig. 3c is a schematic cross-sectional view of a pressure sensor in the guide head shown in fig. 1. Further, as shown in fig. 1 and 3a to 3c, when the piezoelectric film sensor 14 is selected as the pressure sensor, the piezoelectric film sensor 14 may also fill a part of the annular inner cavity, for example, in a stacked structure along the length direction of the guide head 1, so that the piezoelectric film sensor 14 is in contact with the inner tube 11 and the outer tube 12, respectively, and can sense the resistance value received by the free end of the guide head 1 and/or the outer tube 12 in real time while serving as a support structure of the guide tube 1. The carbon nanotube graphene ionic driver 13 and the piezoelectric thin film sensor 14 can be alternately distributed in the annular chamber; for example, the carbon nanotube graphene ionic driver 13 and the piezoelectric thin film sensor 14 fill the whole annular chamber in a crisscross manner (as shown in fig. 1 and 3 b), and both driver electrodes 131 in the carbon nanotube graphene ionic driver 13 extend along the length direction of the guide tube 1 (as shown in fig. 3a and 3 b), respectively, so as to drive the inner tube 11 and the outer tube 12 to bend by changing the driving voltage; meanwhile, the sensor electrodes 141 in the piezoelectric film sensor 14 may also be distributed in the piezoelectric film material for supporting along the length of the lead (as shown in fig. 3b and 3 c) to sense the voltage caused by the deformation of the piezoelectric film in real time, so as to timely obtain the resistance force applied to the free end of the outer tube 12 or the lead 1.

The guide head 1 in the above embodiment, while stacking the piezoelectric thin film material as the support structure, can accurately sense the piezoelectric signal generated by the deformation of the outer tube 12 and the free end due to the resistance, so as to accurately obtain the resistance value borne by the outer tube 12 and the free end during the intervention (or implantation) operation; meanwhile, the carbon nanotube graphene ionic driver 13 is arranged at the free end of the guide head 1, and the guide head can be driven by low voltage to realize large-range and large-angle steering, namely, the steering of the guide head 1 is accurate and controllable while the safety is ensured; in addition, the carbon nanotube graphene ionic driver 13 and the piezoelectric film sensor 14 are alternately distributed in a cross mode, so that the structure of the guide head 1 is compact, multiple functions of automatic flexible operation, force timely feedback and the like can be considered, and automatic intervention operation under autonomous navigation of an intervention catheter is realized while miniaturization design is realized.

Further, the length, diameter and other parameters of the guide head 1 can be prefabricated into a plurality of guide heads 1 with different specifications according to the diameter, length and other parameters of the interventional passing lumen (blood vessel or cavity), and the plurality of guide heads 1 can adopt uniform interfaces to adapt to the same or different catheter bodies, so that the matched guide heads can be selected according to the specific requirements of the current interventional operation in the actual application.

In addition, the connecting end of the guide head 1 is also provided with an interface array for realizing the line fast connection communication, so that the sensor electrode 141 is connected with the motion mechanics sensing system, and the driver electrode 131 is connected with the interventional catheter motion control system, namely, the motion dynamics sensing system can obtain the resistance of the current guide head 1 according to the piezoelectric signal fed back by the sensor electrode 141, and the interventional catheter motion control system can control the driving voltage on the driver electrode 131 according to the navigation data and the resistance output by the motion mechanics sensing system, so that the free end of the guide head 1 can realize accurate steering and advancing.

Fig. 4 is a schematic structural diagram of an interventional catheter in one embodiment. As shown in fig. 4, an interventional catheter may include a catheter body 2 and the guiding head 1 of any of the above embodiments, and the catheter body 2 may have a free connection end (not shown) and a connection terminal (not shown), i.e., the free connection end and the connection terminal are two opposite ends of the catheter body 2; the free connection end of the catheter body 2 is connected with the free end of the guide head 1 in a penetrating manner, the connection terminal of the catheter body 2 can be used for being connected with an external control device 3, and the external control device 3 can be an interventional catheter motion control device, an interventional catheter motion control device and/or a control handle and the like so as to be used for realizing automatic or manual auxiliary interventional operation. Meanwhile, when the connection terminal of the catheter body 2 is connected with the control handle, the built-in guide wire 4 can be used for implantation operation of the stent.

Fig. 5a is a sectional view of the interventional catheter connection end shown in fig. 4, fig. 5b is a perspective view of the interventional catheter connection end shown in fig. 4, and fig. 5c is a sectional view of the interventional catheter connection end interface array shown in fig. 4. Further, as shown in fig. 5a to 5c, the catheter body 2 is provided with an inner hole 23 for through connection of the inner tube 11, that is, the hollow inner cavity 15 and the inner hole 23 are connected through to form a passage located inside the catheter, and the connection terminal 21 of the catheter body 2 may further be provided with an electrode interface array electrically connected to the driving device and the pressure sensor, that is, the electrode interface array may include interfaces such as a driver electrode interface 26 connected to the carbon nanotube graphene ionic driver 13 and a piezoelectric electrode interface 27 electrically connected to the piezoelectric thin film sensor 14, so as to transmit electrical signals to the driving control system and the force sensing system, respectively, thereby facilitating connection of each control line; the electrode port array may be embedded in an inner wall of a connection terminal 21 of the catheter body 2, and an opening 22 penetrating an inner hole 23 is formed in the connection terminal 21. In addition, to facilitate the connection and the stability of the connection, the opening 22 may be provided as a threaded opening (as shown in fig. 5 a), and the subsequent bolting may be performed by means of a bolt structure matching the threaded opening.

Further, an angle reference mark 25 may be further provided at the opening 22 of the connection terminal 21 for performing position calibration at the time of an intervention operation on the guide head 1. For example, the angle reference mark 25 can be a raised structure (as shown in fig. 5 b) protruding from the wall of the connection terminal 21, and a zero-degree angle indication mark is provided on the raised structure, so as to facilitate the control of the steering of the guide head 1 during the interventional operation.

Further, the electrode connection array 28 is distributed in an array manner in each direction of the connection end (as shown in fig. 5 c), so that at least two sets of driving modules (i.e., the carbon nanotube graphene ionic driver 13) and one set of force sensing modules (i.e., the piezoelectric thin film sensor 14) can be simultaneously controlled in each direction, and the guidance head is controlled to realize accurate steering. Meanwhile, in order to ensure that the interventional catheter has strong bending resistance and X-ray resistance, a multi-section thin sheet metal annular structure can be adopted for connecting all sections, namely as shown in fig. 1, the guide head 1 is composed of a plurality of annular section units, and adjacent annular section units are connected through thin sheet metal rings (such as copper rings, aluminum rings or alloy rings) so as to improve the bending resistance and X-ray resistance of the interventional catheter.

Fig. 6a is a schematic structural diagram of an interventional system including a CT device in one embodiment, fig. 6b is a schematic structural diagram of an interventional system including a DSA device in one embodiment, fig. 6c is a schematic structural diagram of an interventional system including a CT device and a DSA device in one embodiment, and fig. 6d is a schematic structural diagram of an interventional system including an MRI device in one embodiment. As shown in fig. 6a to 6d, an interventional system may include a medical imaging device, a propulsion device, a control device, and an interventional catheter in any of the above embodiments, where the medical imaging device may be used to obtain a medical image of a patient at a position, such as a treatment area to be interventional and a planned path, in real time, and the propulsion device may be connected to a connection terminal of a catheter body to control the interventional catheter to perform interventional therapy according to the medical image. The medical hard device may include a mobile CT (Computed Tomography) device, a CBCT (Cone beam CT) device, a DSA device, and/or a mobile MRI (Magnetic Resonance Imaging) device.

As shown in fig. 6a, the interventional system may specifically include a control subsystem 5 (i.e., a control device), a carrying platform 61 and a robot subsystem 63; the control subsystem 5 may comprise a work table 51, a robot control device 52, a work station 53 and a display device 54 of the work station 53 placed on the work table; the carrying platform 61 is used for carrying and fixing a patient 62, the robot subsystem 63 is provided with a propulsion subsystem 64 for propelling instruments such as an interventional catheter and an endoscope, and the movable CT equipment 71 can be used for acquiring medical images of the patient in real time. Specifically, the workstation 53 may process and analyze medical images acquired by the CT device 71 to output and present navigation information through the display device 54, and the robot control device 52 controls the robot subsystem 63 to drive the propulsion subsystem 64 to perform interventional therapy on the patient 62 through the interventional catheter, because the head of the interventional catheter adopts the driving device to steer the guiding head, and the pressure sensor can obtain a resistance value on the head of the interventional catheter in real time, so as to realize accurate turning of the interventional catheter, and effectively control the traction force of the interventional catheter while accurately and effectively guiding the interventional catheter to enter a corresponding target blood vessel or target lumen, so as to avoid damage to the lumen through which the interventional catheter passes due to excessive guiding force, and effectively reduce the risk of causing many complications.

Further, based on different interventional procedures, the CBCT apparatus 72 may be used alone to acquire medical images in the above embodiments, as shown in fig. 6b, the CBCT apparatus 72 may also be replaced by a DSA apparatus; meanwhile, the CT equipment 71 and the CBCT equipment 72 can be adopted to acquire medical images (as shown in figure 6 c), so that the steering precision of the catheter is improved; of course, the operation of acquiring medical images may be performed by moving the MRI apparatus 73. The medical image may be acquired by at least one of the CT device 71, the CBCT device 72, the mobile MRI device 73, and a Digital Subtraction Angiography (DSA) device, so as to improve the flexibility of the interventional therapy.

Fig. 7a is a schematic diagram of an image sequence in an embodiment, fig. 7b is a schematic diagram of a three-dimensional reconstructed image in an embodiment, fig. 7c is a schematic diagram of a virtual lumen in an embodiment, fig. 7d is a schematic diagram of an image sequence based on a spatial coordinate system in an embodiment, fig. 7e is a schematic diagram of extracting lumen position information in an embodiment, fig. 7f is a schematic diagram of extracting lumen attribute parameters in an embodiment, fig. 7g is a schematic diagram of extracting start point information and end point information of a three-dimensional image in an embodiment, fig. 7h is a schematic diagram of a navigation track in an embodiment, and fig. 8 is a schematic flowchart of an interventional method in an embodiment. As shown in fig. 8, an interventional method based on the interventional system in any of the above embodiments may include:

in step S1, a sequence of tomographic images of the patient is acquired using the medical imaging apparatus.

Specifically, a DICOM (Digital Imaging and Communications in Medicine) image sequence scanned and acquired by a CT apparatus, a CBCT apparatus or an MRI apparatus, i.e., a tomographic image sequence 8 as shown in fig. 7a, may be adopted, and the tomographic image sequence 8 may include a plurality of tomographic images 81, while the tomographic image sequence 8 further includes corresponding enhanced scan images.

In step S2, a lumen three-dimensional image is reconstructed and acquired based on the tomographic image sequence.

Specifically, 3D reconstruction is performed based on the above-described acquired tomographic image sequence 8, and based on the extracted lumen path, a lumen three-dimensional image 82 as shown in fig. 7b is acquired; the lumen three-dimensional image 82 may include a blood vessel three-dimensional image and/or a lumen three-dimensional image, and may be specifically set according to actual interventional therapy requirements.

Step S3, a virtual lumen space of each lumen is simulated based on the tomographic image sequence.

Specifically, based on each tomographic image 81 in the above tomographic image sequence 8, information of each image plane lumen (blood vessel and/or lumen) is acquired, and further a virtual lumen space of each lumen can be simulated. For example, the information of the central point of the lumen of each image layer can be obtained, and the information such as the distance r between each central point and the wall corresponding to the central point can be obtained by obtaining the connecting line L between the central points O of the corresponding lumens between the adjacent image layers and combining different angles (such as 15 degrees or 30 degrees) on each image layer, so as to simulate the virtual lumen space of each lumen (as shown in fig. 7 c); the virtual channel space may include a distance d between the starting point and the ending point.

Step S4, acquiring start point information and end point information of the interventional operation on the lumen three-dimensional image.

It should be noted that the operations related to fig. 7d to 7f and 7h can be performed based on the same reference coordinate system or different coordinate systems having characteristic relationships. The following description is given by taking the same reference coordinate system as an example:

first, as shown in fig. 7d, a reference coordinate system may be established based on the patient in the supine position, the X-axis of the reference coordinate system being the horizontal direction, the Y-axis being the vertical direction, and the Z-axis being the human body length (i.e., height) direction. Next, the position information of each tomographic image 81 in the tomographic image series 8 in fig. 7d in the reference coordinate system can be sequentially acquired. Then, based on the above-mentioned respective tomographic images 81 and the position information thereof in the reference coordinate system, position information (x, y, z) of target points such as the center point of the lumen and the tube wall in the respective image layers as shown in fig. 7e is acquired; for example, the acquired position information of the a point is (99, 89, 455), and the position information of the B point is (129, 110, 855). Then, as shown in fig. 7f, the corresponding center points in all the image layers are connected with the tube wall coordinate points to obtain the center line of the 3D reconstructed image and the spatial cavity coordinate information. Finally, the coordinate information of the tomographic image 81a as the start point d1 (i.e., start point information) and the coordinate information of the tomographic image 81b as the end point d2 (i.e., end point information) in the tomographic image sequence 8 are acquired based on the above-described coordinate information.

And step S5, generating navigation information of the intervention operation according to the virtual cavity space of each cavity based on the starting point information and the end point information.

Specifically, as shown in fig. 7h, between the start point d1 and the end point d2, navigation information of the intervention operation is generated based on the virtual channel space according to the respective lumens; for example, based on the trajectory of the central line and the trajectory of the virtual lumen space, the navigation information such as the deflection angle α and the path trajectory at the bifurcation or the bend in the virtual lumen space can be calculated.

And step S6, performing interventional therapy on the patient by using the interventional system based on the navigation information, namely performing intra-luminal guidance on the interventional catheter.

Specifically, based on the navigation information, the interventional system in any of the above embodiments is used to automatically advance layer by layer along the center line (i.e., the path track) in the extending direction from the starting point d1 to the ending point d2, and simultaneously dynamically display the navigation end surfaces of the center line, the spatial cavity, and the like in real time on the display device of the control system, so as to facilitate the doctor to perform the operation and control, thereby implementing the interventional therapy on the patient. In addition, in the propelling process, parameters such as coordinate information of the central line, the distance between the wall of the lumen and the central point, resistance values fed back by the guide head and the like can be dynamically displayed in real time, so that the control accuracy of a doctor is improved.

Furthermore, in the process of advancing the interventional therapy, the relevant information such as the lumen center point, the tube wall coordinate position information, the resistance value and the like of each image layer can be automatically output and stored in file formats such as text files, tables, database files and the like, so that the subsequent data analysis and the record can be conveniently carried out.

The position information may further include parameters such as an image layer where the current leading tip is located, a distance between the current leading tip location and the starting point, a virtual lumen centerline coordinate at the current leading tip location, a deflection angle of a centerline at the current leading tip location, and distances between the centerline at the current leading tip location and the vessel walls in all directions, so that a doctor can conveniently manipulate the interventional catheter and perform subsequent operations such as data analysis and record keeping.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. An introducer head for an interventional catheter, the introducer head having a free end and a connected end, the free end being for guiding the introducer head for steering or/and monitoring, the introducer head comprising:

an inner tube having a hollow interior;

the pressure sensors are arranged on the outer side of the inner pipe and the end part area of the free end and are used for sensing the resistance born by the free end in real time;

the driving device comprises an inner layer driving electrode and an outer layer driving electrode, the inner layer driving electrode and the outer layer driving electrode can generate different voltage values under the action of a control signal generated according to the resistance, so that the driving device can contract leftwards and rightwards or in any direction to drive the inner tube and the outer tube to deform, and further the turning and steering are realized.

2. The guide head of claim 1, wherein the drive device is an ionic drive;

3. The pilot head of claim 2, wherein the ionic driver is a carbon nanotube graphene ionic driver;

4. The guide head of claim 3, wherein the pressure sensor is a piezoelectric film sensor;

5. The guide head of claim 4, wherein the carbon nanotube graphene ionic drivers and the piezoelectric thin film sensors are alternately distributed in the annular chamber.

6. An interventional catheter, comprising:

the guide head of any of claims 1-5;

a catheter body having a free connection end and a connection terminal;

7. The interventional catheter of claim 6, wherein the catheter body has an inner bore therethrough connected with the inner tube; and

8. An interventional catheter of claim 6, wherein an end of the catheter body connection terminal is provided with angular reference markings for positional calibration of the guide head.

9. An interventional system, comprising:

an interventional catheter as defined in any one of claims 6-8;

the medical imaging equipment is used for acquiring medical images in real time;

and the propelling device is used for controlling the interventional catheter to carry out interventional therapy on the patient according to the medical image.

10. A method for generating navigation information of an interventional catheter, based on the interventional system of claim 9, the method comprising:

and generating navigation information according to the virtual cavity space of each cavity based on the starting point information and the end point information, wherein the navigation information is used for guiding the interventional catheter.