CN117974669A

CN117974669A - Online detection and preparation control method and device for implantation and intervention tubular instrument

Info

Publication number: CN117974669A
Application number: CN202410389783.0A
Authority: CN
Inventors: 杨鹏; 谢嘉轩; 赵庆洪; 于洋; 宋歌; 孙浩; 冯汉卿; 刘青
Original assignee: Beijing Advanced Medical Technologies Inc
Current assignee: Beijing Advanced Medical Technologies Inc
Priority date: 2024-04-02
Filing date: 2024-04-02
Publication date: 2024-05-03
Anticipated expiration: 2044-04-02
Also published as: CN117974669B

Abstract

The invention provides a method and a device for on-line detection and preparation control of an implantable and interventional tubular instrument, which belong to the technical field of implantable prostheses.

Description

Online detection and preparation control method and device for implantation and intervention tubular instrument

Technical Field

The invention relates to the technical field of implantable prosthesis, in particular to an on-line detection and preparation control method and device for an implantation and intervention tubular instrument.

Background

Implantable and interventional tubular devices are a type of medical device used for implantation, interventional procedures or examinations in the body, which can be operated in different tissues. For example, the implantable, interventional tubular device may be a catheter for in vivo tissue, a sheath, an artificial blood vessel, a nerve repair catheter, a cardiovascular stent, a digestive tract stent, or the like.

The preparation method of the product mainly comprises 3D printing, electrostatic spinning, braiding, pouring and the like. For these products, different surface defects can affect product performance and product performance, such as surface defects and voids can affect the conductivity of the catheter. For example, for vascular prostheses having a multi-layer structure, too much deviation in wall thickness and coaxiality of the multi-layer structure can affect the slow release effect, surface endothelialization effect, and bending properties of the implanted cargo. Therefore, there is a need to manage the outer wall defects and size defects of these products.

In the preparation process, the product has small size, so that surface defects and size defects generated in the preparation process are difficult to be directly inspected by naked eyes, and an efficient online detection mode is needed to control quality in the preparation process and further adjust preparation parameters online.

Disclosure of Invention

The invention provides an on-line detection and preparation control method and device for a tubular instrument for implantation and intervention, which are used for solving the defect that on-line detection and quality regulation are difficult to perform in the preparation process of the tubular instrument in the prior art, and realizing accurate detection and regulation in the preparation process of the tubular instrument.

The invention provides an on-line detection and preparation control method of an implantation and intervention tubular instrument, the implantation and intervention tubular instrument comprises at least one layer of tubular structure, the tubular structure is a tubular structure with a wall surface closed completely or a porous tubular structure, the tubular structure is prepared by electrostatic spinning, 3D printing, pouring or braiding, and the method comprises the following steps:

In the preparation process of the tubular instrument, acquiring a wall image of the outer side wall surface of the tubular instrument, and acquiring an end surface image of the preparation end surface of the tubular instrument; the preparation end face is one end of the tubular instrument far away from a preparation starting point;

performing target recognition on the wall surface image to obtain an abnormal region recognition result of the outer wall surface; processing the end face image, and extracting to obtain the wall thickness of the tubular structure of the tubular instrument and the gap between the section of the tubular structure of the tubular instrument and a reference circle; the abnormal region comprises a region corresponding to at least one of pits, deletions, holes, clusters, bulges, abnormal wire diameters, wire lap disorder and flying wires;

obtaining a wall thickness detection result and a coaxiality detection result of the tubular instrument based on an abnormal region identification result of the outer wall surface of the tubular instrument under the condition that the wall thickness of the outermost tubular structure of the tubular instrument does not meet the preset thickness condition;

And adjusting preparation parameters of the tubular instrument based on at least one of an abnormal region identification result, a wall thickness detection result and a coaxiality detection result of the outer wall surface of the tubular instrument.

According to the on-line detection and preparation control method of the implantation and intervention tubular instrument provided by the invention, when the thickness of the wall surface of the outermost tubular structure of the tubular instrument does not meet the preset thickness condition, the wall thickness detection result and the coaxiality detection result of the tubular instrument are obtained based on the abnormal region identification result of the outer wall surface of the tubular instrument, and the on-line detection and preparation control method comprises the following steps:

Determining an abnormal region identification result of the outer wall surface corresponding to the abnormal thickness position under the condition that the thickness of the wall surface of the outermost tubular structure of the tubular instrument does not meet the preset thickness condition;

Acquiring the depth of the hole when the thickness abnormal position is too small and the abnormal area identification result of the outer wall surface corresponding to the thickness abnormal position is that the hole exists;

correcting the wall thickness at the position of the thickness abnormality of the outermost tubular structure of the tubular instrument and the gap between the interface of the outermost tubular structure and the reference circle based on the depth of the hole;

And obtaining a wall thickness detection result and a coaxiality detection result of the tubular instrument based on the corrected back thickness and the gap.

determining an offset distance between the top of the flying wire and the outer wall surface of the tubular instrument when the thickness abnormal position is over-thick and the abnormal region identification result of the outer wall surface corresponding to the thickness abnormal position is that the flying wire exists;

Correcting the wall thickness at the position of the thickness abnormality of the outermost tubular structure of the tubular instrument and the gap between the interface of the outermost tubular structure and the reference circle based on the offset distance between the top of the flying wire and the outer wall surface of the tubular instrument;

According to the online detection and preparation control method for the implantation and intervention tubular instrument provided by the invention, under the condition that the preparation method of the tubular instrument is electrostatic spinning, the preparation parameters of the tubular instrument are adjusted based on at least one of the abnormal region identification result, the wall thickness detection result and the coaxiality detection result of the outer wall surface of the tubular instrument, and the online detection and preparation control method comprises the following steps:

And (3) identifying the abnormal region on the outer wall surface of the tubular instrument as a region with pits and deletions, and adjusting the motion parameters and the filament outlet parameters of the electrostatic spinning nozzle to increase the filament outlet quantity of the electrostatic spinning nozzle in the region with pits and deletions.

And under the condition that the abnormal area identification result of the outer wall surface of the tubular instrument is that bulges or clusters exist, adjusting the motion parameters and the yarn outlet parameters of the electrostatic spinning nozzle so as to reduce the yarn outlet quantity of the electrostatic spinning nozzle in the areas where the bulges and the clusters exist.

Determining that an abnormal region identification result of the outer wall surface of the tubular instrument is that no abnormal region exists;

Determining thickness anomaly offsets for each layer of the tubular instrument based on at least one of the wall thickness detection results and the coaxiality detection results;

based on the thickness abnormal offset of each layer structure of the tubular instrument, adjusting the motion parameters and the filament outlet parameters of the electrostatic spinning nozzle, and adjusting the filament outlet quantity of the electrostatic spinning nozzle so as to correct the thickness abnormal offset of each layer structure of the tubular instrument.

According to the online detection and preparation control method of the implantation and intervention tubular instrument provided by the invention, under the condition that the preparation method of the tubular instrument is electrostatic spinning, after target identification is performed on the wall surface image to obtain an abnormal region identification result of the outer wall surface, the method further comprises the following steps:

Determining whether the abnormal region can be repaired based on the abnormal region identification result;

Controlling the preparation device of the tubular instrument to stop working under the condition that the abnormal region cannot be repaired; or in the case that the abnormal region can be repaired, controlling the preparation equipment of the tubular instrument to switch the working parameters so as to repair the abnormal region.

According to the online detection and preparation control method of the implantation and intervention tubular instrument provided by the invention, under the condition that the preparation method of the tubular instrument is 3D printing or braiding, the method further comprises the following steps of:

and determining the abnormal region identification result of the outer wall surface as the abnormal region identification result, and controlling the preparation equipment of the tubular instrument to stop working.

The invention also provides an on-line detection and preparation control device of the implantation and intervention tubular instrument, which comprises the following components:

The image acquisition module is used for acquiring a wall image of the outer side wall surface of the tubular instrument and acquiring an end surface image of the preparation end surface of the tubular instrument in the preparation process of the tubular instrument; the preparation end face is one end of the tubular instrument far away from a preparation starting point;

the first processing module is used for carrying out target recognition on the wall surface image to obtain an abnormal region recognition result of the outer wall surface; processing the end face image, and extracting to obtain the wall thickness of the tubular structure of the tubular instrument and the gap between the section of the tubular structure of the tubular instrument and a reference circle; the abnormal region comprises a region corresponding to at least one of pits, deletions, holes, clusters, bulges and flying filaments;

The second processing module is used for obtaining a wall thickness detection result and a coaxiality detection result of the tubular instrument based on an abnormal region identification result of the outer wall surface of the tubular instrument under the condition that the wall thickness of the outermost tubular structure of the tubular instrument does not meet the preset thickness condition;

The regulation and control module is used for regulating the preparation parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result and the coaxiality detection result of the outer wall surface of the tubular instrument.

The invention also provides an electronic device, which comprises a memory, a processor and a computer program stored on the memory and capable of running on the processor, wherein the processor realizes the on-line detection and preparation control method of the implantation and intervention tubular instrument when executing the program.

The present invention also provides a non-transitory computer readable storage medium having stored thereon a computer program which, when executed by a processor, implements a method of on-line detection and preparation control of an implantable, interventional tubular device as described in any one of the above.

The invention also provides a computer program product comprising a computer program which when executed by a processor implements the method for on-line detection and preparation control of an implantable, interventional tubular device as described in any one of the above.

According to the on-line detection and preparation control method and device for the tubular instrument, provided by the invention, the first camera and the second camera are used for acquiring and processing the wall surface and end surface images of the tubular instrument, so that the automatic detection of the tubular instrument is realized, the abnormal region identification result of the outer wall surface can be obtained, the defect or bad region in the preparation process can be timely found and repaired, and the preparation parameters of the tubular instrument can be adjusted according to the wall surface thickness, coaxiality and abnormal region identification result of the outermost tubular structure of the tubular instrument under the condition of eliminating the interference of the outer wall defect, so that the preparation process of the tubular instrument can be controlled more accurately, the preparation quality of the tubular instrument is further improved, and the production efficiency in the preparation process is also improved.

Drawings

In order to more clearly illustrate the invention or the technical solutions of the prior art, the following description will briefly explain the drawings used in the embodiments or the description of the prior art, and it is obvious that the drawings in the following description are some embodiments of the invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic flow chart of an on-line detection and preparation control method for an implantable interventional tubular device according to the present invention;

FIG. 2 is a second flow chart of the method for on-line detection and preparation control of an implantable interventional tubular device according to the present invention;

FIG. 3 is a schematic view of the on-line detection and preparation control device for an implantable interventional tubular device provided by the present invention;

fig. 4 is a schematic structural diagram of an electronic device provided by the present invention.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

The method and apparatus for on-line detection and preparation control of an implantable interventional tubular device of the present invention are described below with reference to FIGS. 1-4.

Before the on-line detection and preparation control method of the implantation and intervention tubular instrument provided by the embodiment of the invention is described, the implantation and intervention tubular instrument is described.

The implantation and intervention tubular instrument comprises at least one layer of tubular structure, wherein the tubular structure is a tubular structure with a completely closed wall surface or a porous tubular structure, and the tubular structure is prepared by electrostatic spinning, 3D printing, pouring or braiding.

A wall-closed complete tubular structure means that the structure of the tubular instrument is completely closed, without any apertures or openings, similar to a sealed pipe.

The porous tubular structure means that the tubular device structure contains a plurality of micro-voids or channels through which a liquid or gas may pass, and that the structure may provide more functionality, such as promoting cell growth or drug release.

The design of the implantable and interventional tubular instruments can be selected to achieve the desired function and effect according to specific requirements.

Electrospinning can be used to produce tubular devices having nano-or sub-micron pore structures by injecting a polymer or other material in solution or in a molten state into an electric field to form a fibrous structure.

3D printing techniques can create complex three-dimensional structures by stacking materials. For the preparation of implantable tubular devices, printing may be performed using biodegradable materials or metallic materials.

Pouring refers to the process of pouring a liquid or semi-solid material into a mold and solidifying the material in the mold, and is commonly used for preparing a tubular structure with a closed and complete wall surface.

Braiding is a conventional method of making tubular structures by cross-braiding yarns or fibers to form a complete tubular structure that can be used to make sturdy and durable implantable devices.

The implantable and interventional tubular device can be a catheter for in vivo tissue, a sheath, an artificial blood vessel, a nerve repair catheter, a cardiovascular stent, a digestive tract stent, etc.

The on-line detection and preparation control method of the implantation and intervention tubular instrument mainly comprises the steps 110, 120, 130 and 140.

Step 110, in the process of preparing the tubular instrument, acquiring a wall image of the outer side wall surface of the tubular instrument, and acquiring an end surface image of the prepared end surface of the tubular instrument.

In some embodiments, the process of preparing the tubular instrument may use at least two cameras, a first camera may be used to acquire wall images of the exterior side wall of the tubular instrument and a second camera may be used to acquire end face images of the preparation end face of the tubular instrument.

The first camera and the second camera may be high speed cameras carrying macro lenses for better capturing smaller size and moving product images.

In this process, a first camera may be mounted in a position facing the side of the tubular instrument for capturing an image of the outer side wall of the tubular instrument.

If the tubular instrument is stationary rather than rotating during the manufacturing process, a plurality of first cameras may also be provided to obtain the side morphology, texture and other relevant features of the tubular instrument.

The preparation end face is one end of the tubular instrument far away from the preparation starting point and is used for acquiring an end face image of one newly prepared end of the tubular instrument in the preparation process. By acquiring an end face image of one end of the prepared tubular instrument, the flatness, thickness, coaxiality and other characteristics of each layer of structure of the prepared tubular instrument can be evaluated.

It will be appreciated that the acquisition of image data of at least two cameras can be used to check the quality of the tubular instrument, the consistency of morphology, surface defects, etc., and by analyzing these image data, quality control and quality assessment can be performed to ensure that a satisfactory tubular instrument is produced.

Step 120, performing target recognition on the wall surface image to obtain an abnormal region recognition result of the outer wall surface; and processing the end face image, and extracting to obtain the wall thickness of the tubular structure of the tubular instrument and the gap between the section of the tubular structure of the tubular instrument and the reference circle.

It will be appreciated that the tubular device may have a multi-layer structure, and the inner wall and the outer wall of the tubular device under the multi-layer structure may be respectively constructed by an inner wall constructed by a method such as electrostatic spinning, 3D bio-printing, pouring or braiding, and the tubular device may have a single-layer structure, for example, the tubular device may also be an inner wall constructed by a stent alone, which is not limited herein.

In the preparation process of the tubular instrument, wall images of the outer wall surface of the tubular instrument can be acquired, and target recognition is carried out on the images so as to obtain an abnormal region recognition result of the outer wall surface. Target recognition may employ techniques such as computer vision and machine learning to automatically detect and identify objects of interest from images.

In specific implementation, an image processing algorithm and a target recognition model based on deep learning may be used to process the wall image and divide it into a plurality of regions. Then, by performing feature extraction and classification on these areas, abnormal areas can be automatically detected and identified. These abnormal areas may be marked by different colors, shapes or textures for subsequent quality control and repair operations.

The shape features of the abnormal region may be extracted using an image processing technique and a computer vision algorithm, and the size and shape information of the abnormal region may be obtained by analyzing and measuring the extracted shape features.

In this process, the image may also be scaled up or down to a suitable size range, and then the size of the abnormal region and the distance from the reference object may be measured using conventional measuring tools.

In this embodiment, the identified target is an abnormal region of the outer wall surface of the tubular instrument, which abnormality may originate from some problem in the manufacturing process.

The abnormal region comprises at least one region corresponding to pits, deletions, holes, agglomerations, bulges, abnormal filament diameters, filament lap disorder and flying filaments.

Pits refer to small depressions in the surface of the tubular device that may be caused by certain problems in the manufacturing process, such as instability of the electrospinning apparatus, improper spinning voltage or nozzle temperature, etc.

The absence refers to a partial absence of the surface of the tubular device, which may be caused by problems such as non-uniformity of the spinning or printing material, breakage or nozzle blockage during spinning or printing.

Holes refer to distinct voids or cavities that appear in the surface of the tubular device and may be caused by uneven material flow during spinning, bubble formation, or improper spinning parameter settings.

Agglomeration refers to the occurrence of material agglomerates on the surface of a tubular device, which may be caused by agglomeration, accumulation or aggregation of material during printing or spinning, and is generally related to printing or spinning parameters, material properties, environmental conditions, etc.

Protrusions refer to protrusions on the surface of the tubular device, which may be caused by problems of uneven electric field distribution of the electrospinning apparatus, coagulation of the spinning material, or clogging of the nozzle.

Abnormal wire diameter refers to abnormal changes in the diameter of the printed wire material during 3D printing. Typically, 3D printing uses a print wire material with a uniform diameter to ensure accuracy and quality of printing. However, in some cases, an abnormal wire diameter, i.e., uneven or unstable diameter of the printing wire material, may occur. This situation may be caused by material anomalies, temperature anomalies, and incorrect settings of printing parameters.

The lapping disorder of the silk yarns is the condition that the woven silk yarns are in incorrect lapping or overlapping in the weaving process, so that the surface of a product is in disorder and uneven. This may be caused by a yarn quality problem such as an abnormality in the knitting apparatus or an abnormality in yarn tension.

Fly refers to a fiber that is not fully attached to a target area during printing or spinning, and deviates from a predetermined area, which may be caused by factors such as a mistake in a motion parameter of printing, insufficient electrostatic force during electrostatic spinning, scattering of spinning material, or air flow.

It should be noted that, an image processing algorithm (such as a Canny edge detection algorithm) may be used to perform edge detection on each layer structure of the tubular instrument in the end face image, and extract the edges of each layer structure of the tubular instrument.

And dividing the edge of each layer structure according to the edge extraction result, and calculating the distance between each edge and the reference circle. These distances can be used to estimate the wall thickness of the various layers of the tubular device.

The reference circle can be a circle artificially set based on the central axis of the tubular instrument in the image processing process and is used for measuring the coaxiality deviation degree of each layer structure of the tubular instrument so as to obtain a coaxiality detection result. Of course, the reference circle may also be a cross-sectional circle for fixing the tubular device on the 3D printing device or the electrospinning device, or may also be a cross-sectional circle of a stent layer located in the middle in the multilayered vascular prosthesis structure when preparing the vascular prosthesis of the three-layer structure.

On this basis, the gap between each section and the reference circle is determined by analyzing the edge information. A suitable point can be selected on the edge as a cross-sectional boundary and then the distance from the point to the reference circle calculated to obtain the gap at each location.

And 130, obtaining a wall thickness detection result and a coaxiality detection result of the tubular instrument based on the abnormal region identification result of the outer wall surface of the tubular instrument under the condition that the wall thickness of the outermost tubular structure of the tubular instrument does not meet the preset thickness condition.

It should be noted that the preset thickness condition is set according to the actual application requirements of different products.

In the case that the thickness of the wall surface of the outermost tubular structure of the tubular device does not meet the preset thickness condition, the position where the preset thickness condition is not met may be a thin wall surface structure caused by insufficient material in the preparation process. However, since the thickness of the wall surface of the outermost tubular structure of the tubular device is obtained based on the result of edge detection, pixel errors caused by abnormal regions in some manufacturing processes can also cause edge recognition errors.

For example, at the hole location, the edge detection algorithm detects the hole location, resulting in a reduced thickness at the location. Under the condition that the flying wires exist, the lifted flying wires can cause an edge detection algorithm to identify the lifted flying wires, and particularly under the condition that both ends of the flying wires are lapped on the outer wall of the tubular instrument, the flying wires or the flying wires are used as edges, so that the thickness of the identified part is abnormally larger.

In this embodiment, when the thickness of the wall surface of the outermost tubular structure of the tubular device does not satisfy the preset thickness condition, the thickness detection error caused by the abnormal region can be eliminated based on the abnormal region identification result of the outer wall surface of the tubular device, so as to obtain an accurate wall thickness detection result and a coaxiality detection result of the tubular device.

It will be appreciated that the coaxiality index can be calculated from the measured wall thickness and the gap between the cross section and the reference circle. For example, the difference in thickness of the partition walls of different sections, the variance of the gap between the sections and the reference circle, etc. can be calculated.

And 140, adjusting preparation parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result and the coaxiality detection result of the outer wall surface of the tubular instrument.

It will be appreciated that if the wall thickness measurement results show that the wall thickness does not meet the preset thickness condition, or the coaxiality measurement results do not meet the requirement, the wall thickness can be changed by adjusting the material amount or the process parameters in the preparation process.

Based on the wall surface abnormal region identification result, if it is found that the used material is liable to be abnormal or defective, replacement of the material can be considered. Materials with better properties and quality are selected to improve the quality of the tubular device. Or the preparation parameters of the tubular instrument can be adjusted to eliminate the existing abnormal defects or avoid the subsequent abnormal defects.

Based on the results of the on-line detection, if an unsatisfactory situation is found, it may be caused by certain parameters or steps in the preparation process. The preparation parameters can be optimized, and the quality of the prepared product is further ensured.

It can be understood that the quality control detection strategy can be optimized according to the abnormal region identification result, the wall thickness detection result or the coaxiality detection result, and the detection point can be increased or the detection time can be adjusted in the follow-up process so as to improve the monitoring and adjustment capability of the preparation parameters.

According to the on-line detection and preparation control method for the implantation and intervention tubular instrument, provided by the embodiment of the invention, the first camera and the second camera are used for acquiring and processing the wall surface and end surface images of the tubular instrument, so that the automatic detection of the tubular instrument is realized, the abnormal region identification result of the outer wall surface can be obtained, the defect or bad region in the preparation process can be timely found and repaired, and the preparation parameters of the tubular instrument can be more accurately controlled according to the wall surface thickness, coaxiality and abnormal region identification result of the outermost tubular structure of the tubular instrument under the condition of eliminating the interference of the outer wall defect, thereby further improving the preparation quality of the tubular instrument and the production efficiency in the preparation process.

In some embodiments, in a case where the thickness of the layer structure wall surface of the tubular instrument does not satisfy the preset thickness condition, the wall thickness detection result and the coaxiality detection result of the tubular instrument are obtained based on the abnormal region identification result of the outer wall surface of the tubular instrument, which includes the following procedures.

In this embodiment, when the thickness of the wall surface of the outermost tubular structure of the tubular instrument does not satisfy the preset thickness condition, the abnormal region identification result of the outer wall surface corresponding to the thickness abnormal position is determined. And acquiring the depth of the hole when the thickness abnormal position is too small and the abnormal area identification result of the outer wall surface corresponding to the thickness abnormal position is that the hole exists. And correcting the wall thickness at the position of the thickness abnormality of the outermost tubular structure of the tubular instrument and the gap between the interface of the outermost tubular structure and the reference circle based on the depth of the hole. And finally, obtaining the wall thickness detection result and the coaxiality detection result of the tubular instrument based on the corrected back thickness and the gap.

It should be noted that, since the holes are obvious, the boundary between the holes and the surrounding material can be distinguished by the edge detection algorithm, so as to obtain the position information of the holes, and further divide the edges of the holes according to the edges of the holes.

However, the thinness of the holes and walls is caused by different factors, and the defects are treated in different ways. If the thickness detection result of the hole position is not corrected, an incorrect thickness adjustment mode is obtained, and the actual thickness of the hole position is thicker.

The wall thickness at the corresponding position can be corrected according to the size and depth information of the hole, so that the thickness value at the hole position is corrected. After correction, wall thickness analysis and coaxiality analysis can be performed again.

It is understood that the abnormal position of the wall thickness of the outermost tubular structure is determined based on the result of the identification of the abnormal region of the outer wall surface. If a hole is present, the hole depth is obtained. Based on the hole depth, correcting the wall thickness at the position of the thickness abnormality of the outermost tubular structure and the gap between the section of the outermost tubular structure and the reference circle, and obtaining the accurate wall thickness and coaxiality detection result of the whole tubular instrument.

In some embodiments, in a case where the thickness of the layer structure wall surface of the tubular instrument does not satisfy the preset thickness condition, obtaining the wall thickness detection result and the coaxiality detection result of the tubular instrument based on the abnormal region identification result of the outer wall surface of the tubular instrument may include the following procedures.

In this embodiment, when the thickness of the wall surface of the outermost tubular structure of the tubular instrument does not satisfy the preset thickness condition, the abnormal region identification result of the outer wall surface corresponding to the thickness abnormal position is determined. And when the thickness abnormal position is over-thick and the abnormal area identification result of the outer wall surface corresponding to the thickness abnormal position is that the flying wire exists, determining the offset distance between the top of the flying wire and the outer wall surface of the tubular instrument.

And determining the position of the wall surface thickness of the outermost tubular structure of the tubular instrument, which does not meet the preset condition, by a detection method, and identifying an abnormal region to determine the abnormal region. If the flying wire exists at the position of the abnormal thickness, the offset distance between the top of the flying wire and the outer wall surface of the tubular instrument is determined through a proper image processing method or a measurement means.

On the basis, the wall thickness of the position of the thickness abnormality of the outermost tubular structure of the tubular instrument and the gap between the interface of the outermost tubular structure and the reference circle can be corrected based on the offset distance between the top of the flying wire and the outer wall surface of the tubular instrument, and the wall thickness detection result and the coaxiality detection result of the tubular instrument can be obtained based on the corrected wall thickness and gap.

When the flying wire exists, a certain gap exists between the flying wire and the outer wall of the tubular instrument, so that the lifted flying wire is easily misjudged as a part of the outer wall of the tubular instrument when edge detection is performed. In this case, the algorithm would also identify the wire contours as part of the outer wall of the tubular instrument, thereby making the identified thickness anomaly therein larger.

In the abnormal region detection and identification process, more complex image processing methods, such as a deep learning algorithm based on a convolutional neural network, are adopted, so that the flying wire and the outer wall of the tubular instrument can be better distinguished, and a more accurate wall thickness detection result is obtained.

On the basis, the thickness of the wall surface at the position with abnormal thickness can be corrected based on the offset distance between the top of the flying wire and the outer wall surface, the gap between the interface of the outermost tubular structure and the reference circle is correspondingly adjusted, and then the wall thickness detection and the coaxiality detection are carried out based on the corrected back surface thickness and the gap, so that accurate wall thickness and coaxiality detection results are obtained, and the quality of tubular instrument preparation is evaluated.

In some embodiments, as shown in fig. 2, in the case where the preparation method of the tubular instrument is electrospinning, adjusting the preparation parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result, and the coaxiality detection result of the outer wall surface of the tubular instrument may include step 141, step 142, and step 143.

Step 141, determining that the abnormal region identification result of the outer wall surface of the tubular instrument is that no abnormal region exists.

Step 142, determining thickness anomaly offset for each layer structure of the tubular instrument based on at least one of the wall thickness detection result and the coaxiality detection result.

Step 143, adjusting the motion parameters and the filament outlet parameters of the electrostatic spinning nozzle based on the thickness abnormal offset of each layer structure of the tubular instrument, and adjusting the filament outlet quantity of the electrostatic spinning nozzle to correct the thickness abnormal offset of each layer structure of the tubular instrument.

The identification of the abnormal region of the outer wall surface of the tubular instrument may be determined first as the absence of the abnormal region, which means that the outer wall surface is free from abnormal defects during the production of the tubular instrument. Because of the different defect types, the problems of thickness and coaxiality, different preparation control means are needed, and the prepared thickness can be adjusted to obtain the tubular instrument meeting the requirements under the condition of no abnormality caused by surface abnormal defects.

Based on the wall thickness detection result and the coaxiality detection result, the thickness abnormal offset of each layer structure of the tubular instrument can be determined through calculation, and the thickness abnormal offset represents the difference between the thickness of each layer structure of the tubular instrument and a preset value.

In the preparation process of the tubular instrument, the thickness of each layer structure of the tubular instrument needs to be controlled, and the tubular instrument is prepared on the basis of a preset value. However, in the actual manufacturing process, due to material, equipment or operation, there may be a deviation between the thickness of each layer and a preset value, and this deviation is an abnormal deviation of the thickness.

For example, a tubular device design requires a first layer thickness of 2mm and a second layer thickness of 3mm, but the thickness of the first layer A is 1.8mm and the thickness of the second layer B is 3.2mm as measured during the manufacturing process, and the thickness anomaly offset for the first layer A is 0.2mm and the thickness anomaly offset for the second layer B is 0.2mm.

And according to the direction and the size of the thickness abnormal offset, parameters such as the filament outlet speed, the voltage and the like of the electrostatic spinning nozzle are adjusted so as to correct the thickness deviation of the corresponding layer. And adjusting the filament outlet amount of the electrostatic spinning nozzle according to the direction and the size of the thickness abnormal offset, so that the thickness deviation of the corresponding layer is corrected. If the thickness of a certain layer is smaller, the filament output can be increased; if the thickness of a certain layer is larger, the filament output can be reduced. Specifically, if the thickness of a layer is small, the wire-out speed can be increased or the track density of the position can be increased; if the thickness of a layer is greater, the wire take-off speed may be reduced or the track density at that location may be reduced.

In the embodiment, the wall thickness of the tubular instrument meets the preset requirement by adjusting the parameters in the preparation process, so that the wall thickness abnormality and coaxiality abnormality in the preparation process can be corrected, and the quality of the tubular instrument is ensured to meet the preset requirement.

It can be understood that the thickness abnormal offset of each layer structure can be calculated by detecting the wall thickness, so that the difference between the thickness of each layer and a preset value is known, the subsequent adjustment of the preparation parameters is facilitated, and the thickness of the tubular instrument meets the preset requirement. In addition, the wall thickness of the target position can be enabled to meet the requirement of coaxiality on the basis of meeting the requirement of the wall thickness by adjusting the wall thickness.

In some embodiments, in the case where the preparation method of the tubular instrument is electrospinning, adjusting the preparation parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result, and the coaxiality detection result of the outer wall surface of the tubular instrument includes: and (3) identifying the abnormal region on the outer wall surface of the tubular instrument as a region with pits and deletions, and adjusting the motion parameters and the filament outlet parameters of the electrostatic spinning nozzle to increase the filament outlet quantity of the electrostatic spinning nozzle in the region with pits and deletions.

In the case of tubular devices prepared by electrospinning, special remedial measures are required to be taken to adjust if pits and missing areas exist on the outer wall surface. Specifically, the preparation parameters of the tubular instrument, including the motion parameters and the filament-discharging parameters of the electrostatic spinning nozzle, can be adjusted according to at least one of the abnormal region identification result, the wall thickness detection result and the coaxiality detection result.

For the areas with pits and deletions, the areas can be repaired by increasing the filament output of the electrostatic spinning nozzle in the areas. Specifically, the position and the yarn-discharging speed of the electrostatic spinning nozzle can be adjusted according to the position and the size of the abnormal region, so that the electrostatic spinning nozzle can cover the pit and the missing region, and the yarn-discharging amount is increased to fill the region. This may result in a more uniform wall thickness of the tubular device in these areas, thereby improving its quality and reliability.

Besides adjusting the filament output of the electrostatic spinning nozzle, other preparation parameters, such as the movement speed, voltage and the like of the electrostatic spinning nozzle, can be adjusted according to the specific conditions of the abnormal region so as to further optimize the preparation quality of the tubular instrument.

In some embodiments, in the case where the preparation method of the tubular instrument is electrospinning, adjusting the preparation parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result, and the coaxiality detection result of the outer wall surface of the tubular instrument includes: and under the condition that the abnormal area identification result of the outer wall surface of the tubular instrument is that bulges or clusters exist, adjusting the motion parameters and the filament outlet parameters of the electrostatic spinning nozzle so as to reduce the filament outlet quantity of the electrostatic spinning nozzle in the areas where the bulges and the clusters exist.

In the case where the tubular device is produced by electrospinning, if there is an abnormal region of protrusions or clusters on the outer wall surface, appropriate adjustment measures are required. According to at least one of the abnormal region identification result, the wall thickness detection result and the coaxiality detection result, the preparation parameters of the tubular instrument, including the motion parameters and the filament outlet parameters of the electrostatic spinning nozzle, can be adjusted.

For the area where the bulge or the agglomeration exists, the correction can be performed by reducing the filament output of the electrostatic spinning nozzle in the area. Specifically, the position and the yarn outlet speed of the electrostatic spinning nozzle can be adjusted according to the position and the size of the abnormal region so as to reduce the yarn outlet amount of the nozzle in the regions. By reducing the amount of filament output, the spin thickness of the raised or agglomerated areas can be reduced, making the areas more uniform with other portions, thereby improving the quality and performance of the tubular instrument.

Besides adjusting the filament output, other preparation parameters such as the movement speed, voltage and the like of the electrostatic spinning nozzle can be adjusted according to specific conditions so as to further optimize the preparation quality of the tubular instrument.

In some embodiments, in the case that the preparation method of the tubular instrument is electrostatic spinning, after the target recognition is performed on the wall surface image to obtain the abnormal region recognition result of the outer wall surface, the online detection and preparation control method of the implantable and interventional tubular instrument further includes the following procedures.

It may be determined whether the abnormal region can be repaired based on the abnormal region identification result.

In the case that the preparation method of the tubular instrument is electrostatic spinning, the type of the abnormal region can be determined according to the abnormal region identification result. In the case that the abnormal region is a pit or a missing, the shape and area of the pit and the missing abnormal region may be first identified, and whether the repair is possible may be further determined according to the shape and area of the abnormal region.

Under the condition that the abnormal area cannot be repaired, the fact that the product being prepared cannot meet the product quality requirement and cannot be repaired is indicated, the tubular instrument manufacturing equipment is free of use value, and the tubular instrument manufacturing equipment can be controlled to stop working, so that unnecessary material waste is reduced.

Or in the case that the abnormal region can be repaired, controlling the preparation equipment of the tubular instrument to switch the working parameters so as to repair the abnormal region.

When the preparation equipment of the tubular instrument switches the working parameters to repair the abnormal region, the new working parameters can be combined and adjusted in modes of supplying spinning materials, electric field parameters, spinning parameters, positions and the like to repair the abnormal region. Specific parameter adjustment and control strategies need to be determined according to specific conditions and equipment characteristics, and an optimal repairing effect is achieved by combining actual tests and optimization.

In some embodiments, in the case that the preparation method of the tubular instrument is 3D printing, after performing object recognition on the wall surface image to obtain the abnormal region recognition result of the outer wall surface, the method further includes: and determining an abnormal region identification result of the outer wall surface as the abnormal region identification result, and controlling the 3D printing equipment of the tubular instrument to stop working.

It will be appreciated that due to the specificity of the 3D printing device, the entire tubular instrument is printed in a continuous printing mode during the printing process, and once an abnormal area occurs, the product is directly scrapped, and the 3D printing device of the tubular instrument needs to be immediately controlled to stop working so as to reduce unnecessary waste.

In some embodiments, the diameter of the wire during 3D printing may be monitored in real time and trend analysis of the wire diameter may be performed. When the trend of reducing the diameter of the silk thread is detected, the parameters of the 3D printer can be adjusted online to increase the discharge amount of the 3D printer in unit time; when the trend of increasing the diameter of the silk thread is detected, the parameters of the 3D printer can be adjusted online so as to reduce the discharge amount of the 3D printer in unit time.

The on-line detection and preparation control device of the implantation and intervention tubular instrument provided by the invention is described below, and the on-line detection and preparation control device of the implantation and intervention tubular instrument described below and the on-line detection and preparation control method of the implantation and intervention tubular instrument described above can be correspondingly referred to each other.

As shown in fig. 3, the on-line detection and preparation control device for an implantation and intervention tubular instrument according to an embodiment of the present invention mainly includes an image acquisition module 310, a first processing module 320, a second processing module 330, and a regulation and control module 340.

The image acquisition module 310 is used for acquiring a wall image of the outer side wall surface of the tubular instrument and acquiring an end surface image of the prepared end surface of the tubular instrument in the preparation process of the tubular instrument; the preparation end face is one end of the tubular instrument far away from the preparation starting point;

The first processing module 320 is configured to perform target recognition on the wall image, so as to obtain an abnormal region recognition result of the outer wall; processing the end face image, and extracting to obtain the wall thickness of each layer of structure of the tubular instrument and the gap between the section of each layer of structure of the tubular instrument and the reference circle; the abnormal region comprises a region corresponding to at least one of pits, deletions, holes, clusters, bulges, abnormal wire diameters, wire lap disorder and flying wires;

the second processing module 330 is configured to obtain a wall thickness detection result and a coaxiality detection result of the tubular instrument based on an abnormal region identification result of the outer wall surface of the tubular instrument when the wall thickness of the outermost tubular structure of the tubular instrument does not meet a preset thickness condition;

The adjusting module 340 is configured to adjust a preparation parameter of the tubular instrument based on at least one of an abnormal region identification result, a wall thickness detection result, and a coaxiality detection result of an outer wall surface of the tubular instrument.

According to the on-line detection and preparation control device for the implantable and interventional tubular instrument, provided by the embodiment of the invention, the first camera and the second camera are used for acquiring and processing the wall surface and end surface images of the tubular instrument, so that the automatic detection of the tubular instrument is realized, the abnormal region identification result of the outer wall surface can be obtained, the defect or bad region in the preparation process can be timely found and repaired, and the preparation parameters of the tubular instrument can be more accurately controlled according to the wall surface thickness, coaxiality and abnormal region identification result of the outermost tubular structure of the tubular instrument under the condition of eliminating the interference of the outer wall defect, so that the preparation quality of the tubular instrument is further improved, and the production efficiency in the preparation process is also improved.

Fig. 4 illustrates a physical schematic diagram of an electronic device, as shown in fig. 4, which may include: processor 410, communication interface (Communications Interface) 420, memory 430, and communication bus 440, wherein processor 410, communication interface 420, and memory 430 communicate with each other via communication bus 440. The processor 410 may invoke logic instructions in the memory 430 to perform an on-line detection and preparation control method of the implanted, interventional tubular device, the method comprising: in the preparation process of the tubular instrument, acquiring a wall image of the outer side wall surface of the tubular instrument, and acquiring an end surface image of the preparation end surface of the tubular instrument; the preparation end face is one end of the tubular instrument far away from the preparation starting point; performing target recognition on the wall image to obtain an abnormal region recognition result of the outer wall; processing the end face image, and extracting to obtain the wall thickness of the tubular structure of the tubular instrument and the gap between the section of the tubular structure of the tubular instrument and the reference circle; the abnormal region comprises a region corresponding to at least one of pits, deletions, holes, clusters, bulges, abnormal wire diameters, wire lap disorder and flying wires; obtaining a wall thickness detection result and a coaxiality detection result of the tubular instrument based on an abnormal region identification result of the outer wall surface of the tubular instrument under the condition that the thickness of the wall surface of the outermost tubular structure of the tubular instrument does not meet the preset thickness condition; and adjusting preparation parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result and the coaxiality detection result of the outer wall surface of the tubular instrument.

Further, the logic instructions in the memory 430 described above may be implemented in the form of software functional units and may be stored in a computer-readable storage medium when sold or used as a stand-alone product. Based on this understanding, the technical solution of the present invention may be embodied essentially or in a part contributing to the prior art or in a part of the technical solution, in the form of a software product stored in a storage medium, comprising several instructions for causing a computer device (which may be a personal computer, a server, a network device, etc.) to perform all or part of the steps of the method according to the embodiments of the present invention. And the aforementioned storage medium includes: a usb disk, a removable hard disk, a Read-Only Memory (ROM), a random access Memory (RAM, random Access Memory), a magnetic disk, or an optical disk, or other various media capable of storing program codes.

In another aspect, the present invention also provides a computer program product, the computer program product comprising a computer program, the computer program being storable on a non-transitory computer readable storage medium, the computer program, when executed by a processor, being capable of performing the method for controlling the on-line detection and preparation of an implantable and interventional tubular device provided by the above methods, the method comprising: in the preparation process of the tubular instrument, acquiring a wall image of the outer side wall surface of the tubular instrument, and acquiring an end surface image of the preparation end surface of the tubular instrument; the preparation end face is one end of the tubular instrument far away from the preparation starting point; performing target recognition on the wall image to obtain an abnormal region recognition result of the outer wall; processing the end face image, and extracting to obtain the wall thickness of the tubular structure of the tubular instrument and the gap between the section of the tubular structure of the tubular instrument and the reference circle; the abnormal region comprises a region corresponding to at least one of pits, deletions, holes, clusters, bulges, abnormal wire diameters, wire lap disorder and flying wires; obtaining a wall thickness detection result and a coaxiality detection result of the tubular instrument based on an abnormal region identification result of the outer wall surface of the tubular instrument under the condition that the thickness of the wall surface of the outermost tubular structure of the tubular instrument does not meet the preset thickness condition; and adjusting preparation parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result and the coaxiality detection result of the outer wall surface of the tubular instrument.

In yet another aspect, the present invention provides a non-transitory computer readable storage medium having stored thereon a computer program which, when executed by a processor, is configured to perform the method for on-line detection and preparation control of an implantable, interventional tubular device provided by the methods above, the method comprising: in the preparation process of the tubular instrument, acquiring a wall image of the outer side wall surface of the tubular instrument, and acquiring an end surface image of the preparation end surface of the tubular instrument; the preparation end face is one end of the tubular instrument far away from the preparation starting point; performing target recognition on the wall image to obtain an abnormal region recognition result of the outer wall; processing the end face image, and extracting to obtain the wall thickness of the tubular structure of the tubular instrument and the gap between the section of the tubular structure of the tubular instrument and the reference circle; the abnormal region comprises a region corresponding to at least one of pits, deletions, holes, clusters, bulges, abnormal wire diameters, wire lap disorder and flying wires; obtaining a wall thickness detection result and a coaxiality detection result of the tubular instrument based on an abnormal region identification result of the outer wall surface of the tubular instrument under the condition that the thickness of the wall surface of the outermost tubular structure of the tubular instrument does not meet the preset thickness condition; and adjusting preparation parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result and the coaxiality detection result of the outer wall surface of the tubular instrument.

The apparatus embodiments described above are merely illustrative, wherein the elements illustrated as separate elements may or may not be physically separate, and the elements shown as elements may or may not be physical elements, may be located in one place, or may be distributed over a plurality of network elements. Some or all of the modules may be selected according to actual needs to achieve the purpose of the solution of this embodiment. Those of ordinary skill in the art will understand and implement the present invention without undue burden.

From the above description of the embodiments, it will be apparent to those skilled in the art that the embodiments may be implemented by means of software plus necessary general hardware platforms, or of course may be implemented by means of hardware. Based on this understanding, the foregoing technical solution may be embodied essentially or in a part contributing to the prior art in the form of a software product, which may be stored in a computer readable storage medium, such as ROM/RAM, a magnetic disk, an optical disk, etc., including several instructions for causing a computer device (which may be a personal computer, a server, or a network device, etc.) to execute the method described in the respective embodiments or some parts of the embodiments.

Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. The on-line detection and preparation control method of the implantation and intervention tubular instrument is characterized in that the implantation and intervention tubular instrument comprises at least one layer of tubular structure, the tubular structure is a tubular structure with a wall surface closed completely or a porous tubular structure, the tubular structure is prepared by electrostatic spinning, 3D printing, pouring or braiding, and the method comprises the following steps:

2. The method for on-line detection and preparation control of an implantable and interventional tubular device according to claim 1, wherein, in a case where a wall thickness of an outermost tubular structure of the tubular device does not satisfy a preset thickness condition, based on an abnormal region identification result of an outer wall surface of the tubular device, obtaining a wall thickness detection result and a coaxiality detection result of the tubular device, comprises:

3. The method for on-line detection and preparation control of an implantable and interventional tubular device according to claim 1, wherein, in a case where a wall thickness of an outermost tubular structure of the tubular device does not satisfy a preset thickness condition, based on an abnormal region identification result of an outer wall surface of the tubular device, obtaining a wall thickness detection result and a coaxiality detection result of the tubular device, comprises:

4. The method according to claim 1, wherein, in the case where the tubular instrument manufacturing method is electrospinning, the adjusting the manufacturing parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result, and the coaxiality detection result of the outer wall surface of the tubular instrument comprises:

5. The method according to claim 1, wherein, in the case where the tubular instrument manufacturing method is electrospinning, the adjusting the manufacturing parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result, and the coaxiality detection result of the outer wall surface of the tubular instrument comprises:

6. The method according to claim 1, wherein, in the case where the tubular instrument manufacturing method is electrospinning, the adjusting the manufacturing parameters of the tubular instrument based on at least one of the abnormal region identification result, the wall thickness detection result, and the coaxiality detection result of the outer wall surface of the tubular instrument comprises:

7. The method for on-line detection and preparation control of an implantable and interventional tubular device according to claim 1, wherein, in the case that the preparation method of the tubular device is electrospinning, after the target recognition is performed on the wall image to obtain the recognition result of the abnormal region of the outer wall, the method further comprises:

8. The method for on-line detection and preparation control of an implantable and interventional tubular device according to claim 1, wherein, in the case that the preparation method of the tubular device is 3D printing or braiding, after performing object recognition on the wall image to obtain an abnormal region recognition result of the outer wall, the method further comprises:

9. An on-line detection and preparation control device for an implantation and intervention tubular instrument, which is characterized by comprising:

The first processing module is used for carrying out target recognition on the wall surface image to obtain an abnormal region recognition result of the outer wall surface; processing the end face image, and extracting to obtain the wall thickness of the tubular structure of the tubular instrument and the gap between the section of the tubular structure of the tubular instrument and a reference circle; the abnormal region comprises a region corresponding to at least one of pits, deletions, holes, clusters, bulges, abnormal wire diameters, wire lap disorder and flying wires;

10. An electronic device comprising a memory, a processor and a computer program stored on the memory and executable on the processor, wherein the processor implements the method for on-line detection and preparation control of an implantable and interventional tubular device according to any one of claims 1 to 8 when executing the program.