Surgical instrument safety monitoring system, method and device

Abstract

The present application relates to a safety monitoring system, method and device for surgical instruments, belonging to the field of medical instrument technology, which includes: surgical instruments, data acquisition modules and real-time monitoring modules; surgical instruments are used to intervene in the lesion area; the data acquisition module is used to continuously receive the status information of the surgical instruments, and the status information at least includes: the first status information before the surgical instruments are used and the second status information of the surgical instruments at any time when they are used, and / or the second status information of the surgical instruments at least two arbitrary times when they are used; the real-time monitoring module is used to obtain the safety status indication information of the surgical instruments by comparing and analyzing the first status information and the second status information in real time, and / or comparing and analyzing the second status information at at least two arbitrary times in real time. It can solve the safety problem caused by the difficulty in detecting when the surgical instruments are broken or have small cracks, and can improve the safety of ablation surgery.

Description

Technical Field

[0001] The present application relates to a safety monitoring system, method and equipment for surgical instruments, belonging to the technical field of medical instruments. Background Art

[0002] Ablation surgery is a minimally invasive surgery that uses heat to evaporate water in local tissues, coagulate proteins, and cause dry necrosis to achieve the purpose of treatment. Ablation surgery has become a relatively common treatment method and is widely used in clinical departments such as cardiovascular medicine and gastroenterology. Ablation surgery is generally performed using a medical catheter for ablation.

[0003] In a typical medical catheter, the medical catheter includes a fixing component and a catheter connected to the fixing component, wherein the catheter includes an outer tube, an inner tube and an ablation cable or an ablation energy transmission component.

[0004] However, when the above-mentioned medical catheter is used for ablation surgery, the medical catheter may be ruptured or have tiny cracks. Smaller ruptures and tiny cracks are difficult to monitor, which may lead to safety issues. Summary of the invention

[0005] The present application provides a safety monitoring system, method and device for surgical instruments, which can solve the safety problem caused by the difficulty in detecting the breakage or micro-cracks of surgical instruments. The present application provides the following technical solutions:

[0006] In a first aspect, a safety monitoring system for a surgical instrument is provided, characterized in that the system comprises a surgical instrument, a data acquisition module and a real-time monitoring module;

[0007] The surgical instrument is used to intervene in the lesion area;

[0008] The data acquisition module is used to continuously receive status information of the surgical instrument, wherein the status information at least includes: first status information of the surgical instrument before use and second status information of the surgical instrument at any time when the surgical instrument is in use, and / or second status information of at least two arbitrary times when the surgical instrument is in use;

[0009] The real-time monitoring module is used to obtain the safety status indication information of the surgical instrument by performing real-time comparative analysis on the first status information and the second status information, and / or performing real-time comparative analysis on the second status information at at least two arbitrary moments; the real-time monitoring module outputs safety alarm information according to the safety status indication information.

[0010] Optionally, the status information includes at least one of the following: digital image information, electrical signal, ultrasonic signal, optical signal.

[0011] Optionally, a monitoring component is provided on the surgical instrument; the data acquisition module monitors the real-time status of the surgical instrument through the monitoring component to obtain the second status information.

[0012] Optionally, the safety monitoring system further comprises a digital imaging module; the digital imaging module is used to acquire at least one medical digital imaging data of the lesion area and / or the surgical instrument and / or the monitoring component in real time;

[0013] The data acquisition module is connected to the digital imaging module and is used to acquire digital imaging information from at least two arbitrary different moments of the surgical instrument and / or the monitoring component;

[0014] The real-time monitoring module is used to compare and analyze the digital image information of at least two arbitrary different moments in real time and generate safety status indication information of the surgical instrument; the real-time monitoring module outputs safety alarm information according to the safety status indication information.

[0015] Optionally, the surgical instrument comprises a catheter fixing component and a catheter; the catheter fixing component is connected to the proximal end of the catheter;

[0016] The monitoring component is arranged on the catheter and / or the catheter fixing component, and is used to indicate the real-time status of the surgical instrument and generate the digital image information.

[0017] Optionally, the monitoring component includes a membrane layer structure, the membrane layer structure includes a visualization enhancement membrane, and the visualization enhancement membrane is arranged on the outer wall of the catheter.

[0018] Optionally, the monitoring component includes a plurality of storage slots, the storage slots are embedded in the tube wall of the catheter, and the storage slots are filled with developer.

[0019] Optionally, the catheter includes a coaxially arranged energy transmission component, an inner tube and an outer tube; the inner tube is sleeved on the outside of the energy transmission component, and the outer tube is sleeved on the outside of the inner tube.

[0020] Optionally, a water inlet cavity is provided between the inner tube and the energy transmission component, and the water inlet cavity is used for the cooling medium to flow in or out; a water return cavity is provided between the inner tube and the outer tube, and the water return cavity is used for the cooling medium to flow out or in.

[0021] Optionally, the outer wall of the outer tube is provided with a membrane layer structure, and the membrane layer structure includes an anti-cracking protective film and / or a visualization enhancement film and / or a hydrophilic film.

[0022] Optionally, the monitoring component further includes a conductive element and a circuit system; the conductive element is disposed on the surgical instrument, the conductive element is connected to the circuit system, and the circuit system is used to acquire electrical signals at any time in real time.

[0023] Optionally, the circuit system is connected to the real-time monitoring module, and the real-time monitoring module is used to analyze the electrical signal at any time in real time and generate safety status indication information of the surgical instrument; the real-time monitoring module outputs safety alarm information according to the safety status indication information.

[0024] Optionally, the monitoring component further includes an ultrasonic generator and an ultrasonic receiver; the ultrasonic generator is used to generate ultrasonic waves propagating along the catheter; and the ultrasonic receiver is used to receive reflected ultrasonic waves.

[0025] Optionally, the safety monitoring system further comprises a control unit, and the control unit is connected to the real-time monitoring module;

[0026] The real-time monitoring module is used to analyze the ultrasonic signal at any time in real time and generate safety status indication information of the surgical instrument; the real-time monitoring module outputs safety alarm information according to the safety status indication information.

[0027] In a second aspect, a method for safety monitoring of a surgical instrument is provided, the method comprising:

[0028] Acquire first state information and second state information of the surgical instrument, and / or second state information at at least two arbitrary moments;

[0029] Comparing the first state information with the second state information, and / or two pieces of the second state information, to determine whether the surgical instrument has a safety hazard;

[0030] In the event that the surgical instrument presents a safety hazard, a command to stop the surgery is issued.

[0031] According to a third aspect, an electronic device is provided, comprising a memory, a controller, and a computer program stored in the memory and executable on the controller, wherein the controller implements the above-mentioned steps of the method for safety monitoring of surgical instruments when executing the computer program.

[0032] The beneficial effects of the present application are: obtaining the second state information of the surgical instrument, and / or the second state information at at least two arbitrary moments through the data acquisition module; the real-time monitoring module compares the first state information and the second state information, and / or the two second state information, to determine whether there is a safety hazard in the surgical instrument; in the event of a safety hazard in the surgical instrument, the real-time monitoring module issues an operation stop command; the safety problem caused by the difficulty in detection when the surgical instrument is broken or has a small crack can be solved; since the membrane structure on the outer wall of the outer tube includes a visualization enhancement film, a water inlet cavity is provided between the outer tube and the inner tube, and a water return cavity is provided between the inner tube and the energy transmission component, in the event of a break or a small crack in the tube wall of the outer tube, the cooling medium will directly contact the visualization enhancement film, causing the part of the visualization enhancement film in contact with the cooling medium to dissolve in the cooling medium, and as the cooling medium flows out of the catheter, it will cause a high brightness change at the location where the break or small crack occurs, such as graying or faulting, so that the location where the break or small crack occurs in the catheter can be quickly determined, which can improve the safety of the ablation surgery.

[0033] In addition, the membrane layer structure on the outer wall of the outer tube includes an anti-crack protective film. When the catheter ruptures and produces small debris, the anti-crack protective film can remain intact because it has stronger elasticity than the outer tube and the inner tube. Therefore, the debris and cooling medium can be prevented from remaining in the patient's body, and the catheter can be completely removed from the patient's body, thus avoiding complications caused by debris and cooling fluid, thereby improving the safety of the ablation surgery.

[0034] In addition, if the catheter has tiny cracks but is not bent or broken, the operation can still be continued due to the wrapping and protection of the anti-crack protective film, avoiding the need to stop the operation midway and replace the catheter, thereby improving the safety of the ablation surgery.

[0035] In addition, the material of the visualization enhancement film can be a material that changes color when dissolved in water. When the wall of the outer tube is broken or has tiny cracks, the cooling medium will come into direct contact with the visualization enhancement film, dissolve in the cooling medium, and cause the cooling medium to change color. At this time, by observing the color of the cooling medium flowing out of the surgical instrument, it is possible to quickly determine whether the surgical instrument has been broken or has tiny cracks, thereby improving the safety of the ablation surgery.

[0036] The above description is only an overview of the technical solution of the present application. In order to more clearly understand the technical means of the present application and implement it according to the contents of the specification, the following is a detailed description of the preferred embodiments of the present application in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1is a system schematic diagram of a safety monitoring system for surgical instruments provided by an embodiment of the present application;

[0038] Figure 2A is a schematic diagram of the structure of a surgical instrument provided by an embodiment of the present application;

[0039] Figure 2B It is a schematic diagram of a transmission component structure provided by an embodiment of the present application;

[0040] Figure 2C Another transmission component structure diagram provided by an embodiment of the present application is Figure 1 ;

[0041] Figure 2D is a second structural schematic diagram of another surgical instrument provided by an embodiment of the present application;

[0042] Figure 2E This is a schematic diagram of the structure of another surgical instrument provided by an embodiment of the present application. Figure 3 ;

[0043] Figure 3 is a schematic structural diagram of a membrane layer structure provided by an embodiment of the present application;

[0044] Figure 4 is a schematic structural diagram of a membrane layer structure provided by an embodiment of the present application;

[0045] Figure 5 is a schematic diagram of the structure of an ablation procedure provided by an embodiment of the present application;

[0046] Figure 6 is a schematic structural diagram of another ablation procedure provided by an embodiment of the present application;

[0047] Figure 7 This is a schematic diagram of the structure of a catheter bending provided by an embodiment of the present application;

[0048] Figure 8 This is a schematic diagram of a ruptured catheter structure provided by an embodiment of the present application;

[0049] Fig. 9 is a schematic structural diagram of another surgical instrument provided by an embodiment of the present application;

[0050] Fig.10 is a schematic structural diagram of another surgical instrument provided by an embodiment of the present application;

[0051] Fig.11A is a schematic diagram of an ultrasonic generator and an ultrasonic receiver provided by an embodiment of the present application;

[0052] Figure 11B-1This is an example of monitoring with electrical signals provided by an embodiment of the present application. Figure 1 ;

[0053] Figure 11B-2 This is a second schematic diagram of monitoring using electrical signals provided by an embodiment of the present application;

[0054] Figure 11C-1 This is an example of monitoring with electrical signals provided by an embodiment of the present application. Figure 3 ;

[0055] Figure 11C-2 This is an example of monitoring with electrical signals provided by an embodiment of the present application. Figure 4 ;

[0056] Fig.11D is a schematic diagram of a system for monitoring using electrical signals provided by an embodiment of the present application;

[0057] Fig.12 is a schematic diagram of the structure of a cooling assembly provided by an embodiment of the present application;

[0058] Fig.13 It is a flowchart of a safety monitoring method for a surgical instrument provided by an embodiment of the present application;

[0059] Fig.14 is a block diagram of a safety monitoring device for a surgical instrument provided by an embodiment of the present application;

[0060] Fig.15 It is a block diagram of an electronic device provided by an embodiment of the present application. DETAILED DESCRIPTION

[0061] The technical solution of the present application will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The present application will be described in detail below with reference to the accompanying drawings and in conjunction with the embodiments. It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict.

[0062] It should be noted that the terms "first", "second", etc. in the specification and claims of this application and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence.

[0063] In the present application, unless otherwise specified, the directional words used, such as "up, down, top, bottom", usually refer to the directions shown in the drawings, or to the components themselves in the vertical, perpendicular or gravity directions; similarly, for ease of understanding and description, "inside and outside" refer to the inside and outside relative to the outline of each component itself, but the above-mentioned directional words are not used to limit the present application.

[0064] Figure 1 It is a structural diagram of a safety monitoring system for surgical instruments provided in one embodiment of the present application. The safety monitoring system includes at least a surgical instrument 110, a data acquisition module 120 and a real-time monitoring module 130.

[0065] The surgical instrument 110 refers to a medical catheter having a monitoring component and a membrane structure. In this embodiment, the surgical instrument 110 is used to intervene in the lesion area, transmit ablation energy, and perform ablation surgery.

[0066] like Figure 2A As shown, the surgical instrument 110 includes a catheter fixing component 21 and a catheter 22, wherein the catheter 22 has a proximal end and a distal end, and a catheter body extending between the proximal end and the distal end; the catheter fixing component 21 is connected to the proximal end of the catheter 22. The catheter fixing component 21 and the catheter body form a receiving cavity; the catheter 22 includes a coaxially arranged energy transmission component 23, an inner tube 24 and an outer tube 25. The inner tube 24 is sleeved on the outer side of the energy transmission component 23, and the outer tube 25 is sleeved on the outer side of the inner tube 24. In addition, the surgical instrument 110 also includes a transmission component 300.

[0067] Among them, the transmission component 300 is arranged at the connection end of the catheter fixing component 21; the energy transmission component 23 is arranged in the accommodating cavity through the transmission component part, and the transmission component 300 can drive the energy transmission component 23 to realize rotation and linear motion in the accommodating cavity.

[0068] In addition, the catheter fixing component 21 is provided with a first lumen 210 and a second lumen 211 communicating with the accommodating cavity, and the first lumen 210 and the second lumen 211 are communicated with the cooling medium.

[0069] The cooling medium is used to cool the energy transmission component 23 and / or control the temperature in the accommodating cavity and / or the lesion area.

[0070] Optionally, the cooling medium may be physiological saline or distilled water, etc. This embodiment does not limit the selection of the cooling medium.

[0071] In a preferred embodiment, if Figure 2B As shown, the connecting end of the catheter fixing component 21 has an external thread, the transmission component 300 is a fixing nut 301, the fixing nut 301 is provided with an internal thread, the energy transmission component 23 passes through the fixing nut 301, and the energy transmission component 23 and the fixing nut 301 are fixed under the tightening of the sealing plug 302. In this embodiment, by adding a fixing nut, when the energy transmission component 23 (such as an optical fiber) needs to be adjusted, by loosening the fixing nut, the optical fiber and the sealing plug are in a relatively loose state, and the optical fiber can be adjusted to move linearly or rotate, and then the fixing nut is tightened to achieve the tightening of the optical fiber.

[0072] like Figure 2C , Figure 2D , Figure 2E As shown, in another preferred embodiment, in order to control the moving accuracy of the transmission component 300, the transmission component 300 includes a limit nut 3011 and a rotating nut 3012, and the limit nut 3011 and the rotating nut 3012 are movably screwed to the connecting end of the catheter fixing component 21. The energy transmission component 23 is fixed on the rotating nut 3012, and the sealing plug 302 is fixed on the energy transmission component 23 and plays a sealing role. When the energy transmission component 23 needs to be moved, the rotating nut 3012 is rotated, and when it is rotated to the required position, the limit nut 3011 is rotated and moved until one end of the limit nut 3011 is limited and abutted against one end of the rotating nut 3012.

[0073] In this embodiment, not only the linear motion or rotational motion of the energy transmission component 23 can be achieved through the transmission component, but also the movement accuracy of the energy transmission component 23 can be achieved through the limit nut and the rotating nut.

[0074] In this embodiment, the membrane structure 31 is sleeved on the outside of the conduit 22 . Optionally, the outer wall of the outer tube 25 is provided with the membrane structure 31 .

[0075] like Figure 3 and Figure 4 As shown, the membrane structure 31 is arranged on the outside of the catheter 22 , which is equivalent to arranging the membrane structure 31 on the outer wall of the outer tube 25 . The membrane structure 31 includes an anti-cracking protective film 41 and / or a visualization enhancement film 42 and / or a hydrophilic film 43 .

[0076] The anti-cracking protective film 41 is used to wrap the catheter 22 ; and the visualization enhancement film 42 is used to enhance the contour visualization of the catheter 22 .

[0077] Since the catheter 22 may generate debris after being ruptured or broken, the anti-crack protective film 41 can prevent the debris from escaping from the catheter 22 and entering the patient's body, thereby protecting the patient's safety.

[0078] Optionally, the material of the anti-cracking protection film 41 may be polypropylene homopolymer.

[0079] like Figure 5 As shown, when performing an ablation operation, the catheter 22 needs to be sent into the lesion area. When the internal stress of the catheter 22 is unbalanced or the external force applied to the catheter 22 is large, the catheter 22 may be deformed as shown in FIG. Figure 6 and Figure 7 The bending or twisting shown may cause the catheter 22 to rupture or break, generating small debris. At this time, the anti-crack protective film 41 can wrap the debris to prevent the debris from escaping, and then the catheter 22 can be completely removed to avoid the debris remaining in the patient's body.

[0080] In addition, when the catheter 22 only has tiny cracks and is not bent or broken, the catheter 22 can still be used for surgery due to the wrapping and protection of the anti-crack protective film 41.

[0081] In addition, if Figure 8 As shown, if the outer tube 25 or the inner tube 24 is broken due to its own reasons, the anti-cracking protective film 41 can still play a protective role.

[0082] In this embodiment, in order to achieve safety monitoring of the surgical instrument 110, the data acquisition module 120 continuously receives the status information of the surgical instrument 110, and then the real-time monitoring module 130 performs real-time comparative analysis on the status information of the surgical instrument 110 to obtain the safety status indication information of the surgical instrument, and then outputs safety warning information based on the safety status indication information.

[0083] The state information includes first state information before the surgical instrument 110 is used and second state information of the surgical instrument 110 at any time when it is used, and / or second state information of at least two arbitrary times when the surgical instrument 110 is used. The state information includes digital image information, electrical signals, ultrasonic signals, optical signals, etc., and may also be any combination of digital image information, electrical signals, ultrasonic signals, and optical signals.

[0084] Optionally, the data acquisition module 120 includes a computer, a tablet computer, a server or other equipment, and this embodiment does not limit the selection of the data acquisition module 120 .

[0085] Optionally, the real-time monitoring module 130 may include a computer, a tablet computer, a server or other equipment, and this embodiment does not limit the selection of the real-time monitoring module 130 .

[0086] In this embodiment, a connection relationship is pre-established between the real-time monitoring module 130 and the data acquisition module 120 . Based on the connection relationship, the real-time monitoring module 130 can receive the second status information of the surgical instrument 110 acquired by the data acquisition module 120 .

[0087] Optionally, the real-time monitoring module 130 also pre-stores the first state information of the surgical instrument 110, and the first state information is the state information of the complete surgical instrument 110 without bending, twisting, breaking or micro-cracks. After receiving the second state information of the surgical instrument 110 acquired by the data acquisition module 120, the real-time monitoring module 130 performs real-time comparative analysis on the state information of the surgical instrument 110 according to different state information, including at least the following situations:

[0088] In the first case, the status information is first status information before the surgical instrument 110 is used and second status information at any time when the surgical instrument 110 is used.

[0089] Based on this, the real-time monitoring module 130 performs real-time comparative analysis on the status information of the surgical instrument 110 , which refers to performing real-time comparative analysis on the first status information of the surgical instrument 110 before use and the second status information of the surgical instrument 110 at any time during use.

[0090] For example, taking the status information as digital image information, the first status information is the complete digital image information of the surgical instrument 110 before the operation, and the second status information is the digital image information of the surgical instrument 110 acquired by the data acquisition module 120 at time A during the operation; wherein time A is any time during the operation; the real-time monitoring module 130 compares and analyzes the complete digital image information before the operation with the digital image information acquired by the data acquisition module 120 at time A.

[0091] When the first state information is the same as the second state information, it can be determined that the current state of the catheter 22 is in good condition, that is, there is no bending, twisting or rupture, and the ablation operation can continue; when the first state information is different from the second state information, that is, the catheter 22 is bent, twisted or ruptured, at this time, the real-time monitoring module 130 displays an instruction to stop the operation.

[0092] The second type of status information is second status information of the surgical instrument 110 at at least two arbitrary moments when the surgical instrument 110 is in use.

[0093] Based on this, the real-time monitoring module 130 performs real-time comparative analysis on the status information of the surgical instrument 110 , which means performing real-time comparative analysis on the second status information of at least two arbitrary moments when the surgical instrument 110 is used.

[0094] For example: taking the status information as digital image information, the second status information at at least two arbitrary moments includes the digital image information of the surgical instrument 110 acquired by the data acquisition module 120 at time A and time B during the operation, wherein time A is different from time B, and time A and time B can be any moments during the operation; the real-time monitoring module 130 compares and analyzes the digital image information acquired at time A with the digital image information acquired at time B.

[0095] When the second state information at different times is the same, it can be determined that the current state of the catheter 22 is in good condition, that is, there is no bending, twisting or rupture, and the ablation operation can continue; when the second state information at different times is different, that is, the catheter 22 is bent, twisted or ruptured, at this time, the real-time monitoring module 130 displays an instruction to stop the operation.

[0096] In order to achieve the above functions, in this embodiment, a monitoring component is provided on the surgical instrument 110. The monitoring component is provided on the catheter 22 and / or the catheter fixing component 21, and is used to indicate the real-time status of the surgical instrument 110 and generate digital image information. At this time, the safety monitoring system also includes a digital imaging module, which is used to obtain at least one medical digital imaging data of the lesion area and / or the surgical instrument 110 and / or the monitoring component in real time.

[0097] Optionally, the digital imaging module may include a mobile CT (Computed Tomography) device, a CBCT (Cone beam CT) device, or a mobile MRI (Magnetic Resonance Imaging) device, etc. This embodiment does not limit the implementation method of the digital imaging module.

[0098] The monitoring component includes a visualization enhancement membrane 42 in the membrane structure 31. The visualization enhancement membrane 42 is disposed on the outer wall of the catheter 22.

[0099] Optionally, the material of the visualization enhancement film 42 may be a water-soluble paramagnetic material, such as perfluorocarbon nanoemulsion, superparamagnetic iron oxide, etc. This embodiment does not limit the selection of the paramagnetic material.

[0100] Since the material of the visualization enhancement film 42 is a paramagnetic material, the visualization enhancement film 42 can enhance the contour development of the catheter 22 during magnetic resonance.

[0101] In this embodiment, in order to avoid the safety problems caused by the rupture or small cracks in the catheter 22 which are difficult to monitor, as shown in FIG. Fig. 9 As shown, a water inlet cavity 91 is provided between the inner tube 24 and the energy transmission component 23, and the water inlet cavity 91 is used for the cooling medium to flow in or out; a water return cavity 92 is provided between the inner tube 24 and the outer tube 25, and the water return cavity 92 is used for the cooling medium to flow out or in.

[0102] In actual implementation, the positions of the water inlet cavity 91 and the water return cavity 92 may also be interchanged. This embodiment does not limit the implementation method of the water inlet cavity 91 and the water return cavity 92.

[0103] Since the water inlet cavity 91 is arranged between the inner tube 24 and the outer tube 25, and the visualization enhancement film 42 is arranged on the outer wall of the catheter 22, that is, the outer wall of the outer tube 15, when the tube wall of the outer tube 15 is broken or has tiny cracks, the cooling medium will directly contact the visualization enhancement film 42. At this time, since the material of the visualization enhancement film 42 is a water-soluble material, the cooling medium will enter the visualization enhancement film 42 and contact it through the capillary effect. The part in contact with the cooling medium will dissolve in the cooling medium or the development effect of the visualization enhancement film 42 will deteriorate, and its high brightness in the digital image information will change. Therefore, the broken part of the outer tube 25 will appear gray in the digital image information, thereby indicating the location of the break or tiny crack on the tube wall of the outer tube 25.

[0104] In actual implementation, the material of the visualization enhancement film 42 may also be a colored material that changes color when exposed to water, such as anhydrous copper sulfate or anhydrous cobalt chloride. This embodiment does not limit the selection of colored materials.

[0105] When the conduit 22 is intact, the color of the cooling medium flowing out through the return water cavity 92 in the conduit 22 remains unchanged; when the conduit 22 is broken or has tiny cracks, the part of the visualization enhancement film 42 in contact with the cooling medium will dissolve in the cooling medium, causing the color of the cooling medium flowing out through the return water cavity 92 to change. It can be judged that the conduit 22 is broken by observing the color of the flowing cooling medium.

[0106] In addition, in the event that the catheter 22 is ruptured or has tiny cracks, the anti-crack protective film 41 is also used to wrap the cooling medium to prevent the cooling medium from leaking out and prevent the cooling medium from flowing into the patient's body.

[0107] Optionally, the membrane layer structure 31 further includes a hydrophilic membrane 43 .

[0108] The hydrophilic film 43 is disposed on the outside of the anti-crack protective film 41 to reduce the friction between the catheter 22 and the surrounding tissues, improve the hydrophilicity and lubricity of the surface of the catheter 22, and reduce the difficulty of the catheter 22 entering the patient's body.

[0109] Optionally, a hydrophilic membrane is also provided on the inner wall of the outer tube 25 and the outer wall and inner wall of the inner tube 24 .

[0110] Since the cooling medium is liquid, after the inner wall of the outer tube 25 and the outer wall and inner wall of the inner tube 24 are coated with a hydrophilic film, it is more difficult for small bubbles to adhere to the inner tube 24 and the outer tube 25, which can reduce the possibility of bubbles appearing at the light output position, thereby ensuring the success rate of light output. Similarly, after the outermost layer of the catheter 22 is coated with a hydrophilic film, it can also prevent the original bubbles in the cavity from adhering to the outer wall during the puncture process.

[0111] Optionally, the material of the hydrophilic film 43 may be sodium hyaluronate.

[0112] Optionally, the distal end of the catheter 22 is hemispherically closed by an outer tube 25 .

[0113] The distal end is an end that is not connected to the catheter fixing component.

[0114] In this embodiment, the distal end of the catheter 22 is sealed by the hemispherical structure at the distal end of the outer tube 25 to ensure that the energy transmission component 13 does not come into direct contact with the surrounding tissue during the ablation operation. At the same time, it can ensure that the cooling medium in the catheter 22 can flow back normally to prevent the cooling medium from penetrating into the surrounding tissue.

[0115] In another example, the monitoring component further includes a plurality of storage slots, which are embedded in the tube wall of the conduit 22 and filled with developer.

[0116] like Fig.10 As shown, a storage groove 101 is provided in the tube wall of the catheter 22, that is, the tube wall of the outer tube 25, for placing the developer. When the catheter 22 is broken due to bending, the developer will flow out of the catheter 22, and the image information of the surgical instrument will change, thereby indicating the location of the rupture of the catheter 22.

[0117] For example: Reference Fig.10 Four storage slots 101 are provided in the conduit 22 for placing liquid developer. In the digital image information, the four storage slots 101 will present four straight developing lines. When the conduit 22 is broken, the liquid developer will flow out and seep onto other structural parts of the conduit 22. At this time, a developing area will appear in the digital image information, thereby determining that the conduit 22 is broken.

[0118] Optionally, the storage slot may be in a strip shape or in a surrounding shape, and this embodiment does not limit the implementation method of the storage slot.

[0119] In another preferred implementation, Fig.11A As shown, the monitoring component also includes an ultrasonic generator 1110 and an ultrasonic receiver 1120; the safety monitoring system also includes a control unit 1130, and the control unit 1130 is connected to the real-time monitoring module 130; at this time, the second state information of the surgical instrument 110 at any time when in use is an ultrasonic signal, and the real-time monitoring module 130 is used to analyze the ultrasonic signal at any time in real time and generate safety state indication information of the surgical instrument 110, at this time, there is no need to compare with the first state information; the real-time monitoring module 130 outputs safety warning information according to the safety state indication information. The ultrasonic generator 110 is used to generate ultrasonic waves propagating along the catheter 22.

[0120] In this embodiment, the ultrasonic generator 1110 is connected to the control unit 1130. The control unit 1130 is used to control the ultrasonic generator 1110 to emit ultrasonic waves.

[0121] The ultrasonic receiver 1120 is used to receive reflected ultrasonic waves, and the control unit 1130 determines whether the catheter 22 has a rupture or a microcrack based on the received ultrasonic waves.

[0122] In another preferred embodiment, the monitoring component further includes a conductive element and a circuit system; the conductive element is provided on the surgical instrument, and the conductive element is connected to the circuit system, and the circuit system is used to obtain the electrical signal at any time in real time. The circuit system is connected to the real-time monitoring module, and the real-time monitoring module 130 is used to analyze the electrical signal at any time in real time and generate safety status indication information of the surgical instrument; the real-time monitoring module 130 outputs safety alarm information according to the safety status indication information. Specifically, as shown in Figures 11B, 11C and Fig.11D As shown, the monitoring component also includes a conductive element, which is a conductive wire 201. The conductive wire 201 is arranged on the outer tube 25, or embedded in the tube wall of the outer tube 25, or arranged between the outer tube 25 and the membrane structure. Correspondingly, the safety monitoring system also includes a circuit system 202, and the positive and negative electrodes of the conductive wire 201 are connected to the circuit system 202. The circuit system 202 is used to monitor the electrical signal of the conductive wire 201 in real time. When the catheter 22 is damaged, the conductive wire 201 will contact with the cooling medium to cause a circuit break and / or short circuit, and / or the conductive wire 201 and the outer tube 25 will be damaged together. At this time, the electrical signal obtained by the circuit system 202 will change, and according to the change, it can be used as a basis for whether the catheter 22 is damaged.

[0123] Optional, such as Figure 11B-1 and Figure 11B-2 As shown, the conductive wire 201 is a U-shaped conductive wire 201 that is connected to the circuit system 202 and is embedded in the wall of the outer tube 25. When the catheter 22 is damaged, the conductive wire 201 and the outer tube 25 are broken together, so the original conductive circuit will be broken. At this time, the electrical signal obtained by the circuit system 202 will change. According to the change, it can be used as a basis for whether the catheter 22 is damaged. Optionally, Figure 11C-1 and Figure 11C-2As shown, the conductive wire 201 further includes a first conductive wire 2011 and a second conductive wire 2022 both connected to the circuit system, and the first conductive wire 2011 and the second conductive wire 2022 are two unconnected conductive wires. When the catheter 22 is not damaged, the first conductive wire 2011 and the second conductive wire 2022 are not conductive due to being disconnected. When the catheter 22 is broken, the cooling medium (such as saline) will contact the first conductive wire 2011 and the second conductive wire 2022, and then the circuit system 202 will measure an electrical signal, and it can be determined whether the catheter 22 is damaged based on the electrical signal. In addition, this solution can be used in a magnetic resonance environment.

[0124] Taking electrical signals as an example, the real-time monitoring module 130 performs real-time comparative analysis on the status information of the surgical instrument 110, which at least includes:

[0125] For example: taking the state information as electrical signal information, the first state information is the electrical signal information A1 of the surgical instrument 110 before the operation, and the second state information is the electrical signal information A2 of the surgical instrument 110 acquired by the data acquisition module 120 at time A during the operation; wherein time A is any time during the operation; the real-time monitoring module 130 compares and analyzes the electrical signal information A1 before the operation with the electrical signal information A2 acquired by the data acquisition module 120 at time A.

[0126] When the first state information is the same as the second state information, it can be determined that the current state of the catheter 22 is in good condition, that is, there is no bending, twisting or rupture, and the ablation operation can continue; when the first state information is different from the second state information, that is, the catheter 22 is bent, twisted or ruptured, at this time, the real-time monitoring module 130 displays an instruction to stop the operation.

[0127] For another example: the second state information at at least two arbitrary moments includes the electrical signal information of the surgical instrument 110 acquired by the data acquisition module 120 at moment A and moment B during the operation, wherein moment A is different from moment B, and moment A and moment B can be any moments during the operation; the real-time monitoring module 130 compares and analyzes the electrical signal information acquired at moment A with the electrical signal information acquired at moment B.

[0128] When the second state information at different times is the same, it can be determined that the current state of the catheter 22 is in good condition, that is, there is no bending, twisting or rupture, and the ablation operation can continue; when the second state information at different times is different, that is, the catheter 22 is bent, twisted or ruptured, at this time, the real-time monitoring module 130 displays an instruction to stop the operation.

[0129] Optionally, the safety monitoring system further includes a cooling component, which is used to control the cooling medium to flow into or out of the conduit 22 .

[0130] like Fig.12 As shown, the cooling assembly includes a cooling box 121 , a peristaltic pump 122 , a water outlet pipe 123 , a water return pipe 124 , a flow sensor 125 and a waste liquid tank 126 .

[0131] The cooling box 121 stores cooling medium.

[0132] The peristaltic pump 122 is connected to the cooling box 121 and is used to extract the cooling medium in the cooling box 121. At the same time, the peristaltic pump 122 is also connected to the water outlet pipe 123, and the cooling medium is sent into the conduit 22 through the water outlet pipe 123.

[0133] The outlet pipe 123 is connected to the first cavity pipe in the conduit 22, and the cooling medium flows into the water inlet cavity 91 through the first cavity pipe, and then flows out through the water return cavity 92 connected to the water inlet cavity 91. At this time, the water return cavity 92 is also connected to the second cavity, and the second cavity is connected to the water return pipe 124; after the cooling medium flows out of the second cavity, it flows into the waste liquid tank 126 through the water return pipe 124.

[0134] In addition, a flow sensor 125 is also provided on the return pipe 124 for detecting the flow of the cooling medium.

[0135] In summary, the safety monitoring system for surgical instruments provided by the present application obtains the first state information and the second state information of the surgical instrument, and / or the second state information at at least two arbitrary moments, through the data acquisition module; the real-time monitoring module compares the first state information and the second state information, and / or the two second state information to determine whether there is a safety hazard in the surgical instrument; in the event of a safety hazard in the surgical instrument, the real-time monitoring module issues an operation stop command; the safety problem caused by the difficulty in detecting when the medical catheter is broken or has a small crack can be solved; since the membrane layer structure on the outer wall of the outer tube includes a visualization enhancement film, a water inlet cavity is provided between the outer tube and the inner tube, and a water return cavity is provided between the inner tube and the energy transmission component, in the event of a break or a small crack in the wall of the outer tube, the cooling medium will directly contact the visualization enhancement film, causing the part of the visualization enhancement film in contact with the cooling medium to dissolve in the cooling medium, and as the cooling medium flows out of the catheter, the location where the break or small crack occurs will appear gray or faulted, thereby quickly determining the location where the catheter has a break or a small crack, thereby improving the safety of the ablation surgery.

[0136] In addition, the membrane layer structure on the outer wall of the outer tube includes an anti-crack protective film. When the catheter ruptures and produces small debris, the anti-crack protective film can remain intact because it has stronger elasticity than the outer tube and the inner tube. Therefore, the debris and cooling medium can be prevented from remaining in the patient's body, and the catheter can be completely removed from the patient's body, thus avoiding complications caused by debris and cooling fluid, thereby improving the safety of the ablation surgery.

[0137] In addition, if the catheter has tiny cracks but is not bent or broken, the operation can still be continued due to the wrapping and protection of the anti-crack protective film, avoiding the need to stop the operation midway and replace the catheter, thereby improving the safety of the ablation surgery.

[0138] In addition, the material of the visualization enhancement film can be a material that changes color when dissolved in water. When the wall of the outer tube is broken or has tiny cracks, the cooling medium will come into direct contact with the visualization enhancement film, dissolve in the cooling medium, and cause the cooling medium to change color. At this time, by observing the color of the cooling medium flowing out of the surgical instrument, it is possible to quickly determine whether the surgical instrument has been broken or has tiny cracks, thereby improving the safety of the ablation surgery.

[0139] Fig.13 is a flowchart of a safety monitoring method for surgical instruments provided by an embodiment of the present application. Figure 1 The safety monitoring system for surgical instruments shown in the figure. The method comprises at least the following steps:

[0140] Step 1301: Acquire first state information and second state information of a surgical instrument, and / or second state information at at least two arbitrary moments.

[0141] The first state information refers to the state information of the surgical instrument before use, which is the state information of a complete surgical instrument without bending, twisting or breaking; the second state information refers to the state information of the surgical instrument during use. The state information includes at least one of the following: digital image information, electrical signal, ultrasonic signal, optical signal.

[0142] In one example, the status information is digital image information of a surgical instrument, and the digital image information of the surgical instrument can be obtained through a digital imaging module.

[0143] Optionally, the digital imaging module may include a mobile CT (Computed Tomography) device, a CBCT (Cone beam CT) device, or a mobile MRI (Magnetic Resonance Imaging) device, etc. This embodiment does not limit the implementation method of the digital imaging module.

[0144] In this embodiment, the digital imaging module is prepared to obtain the second status information of the surgical instrument at a preset time interval.

[0145] Among them, the preset time length and the pre-set time length can be 0.5 seconds, 1 second or 1.5 seconds, etc. This embodiment does not limit the selection of the preset time length.

[0146] Step 1302: Compare the first state information and the second state information, and / or the two second state information, to determine whether there is a safety hazard in the surgical instrument.

[0147] In this embodiment, the first state information is pre-stored in the real-time monitoring module. After receiving the second state information acquired by the data acquisition module, the real-time monitoring module performs real-time comparative analysis on the state information of the surgical instrument according to different state information, including at least the following situations:

[0148] In the first case, the status information is first status information before the surgical instrument is used and second status information at any time when the surgical instrument is used.

[0149] Based on this, the real-time monitoring module performs real-time comparative analysis on the status information of the surgical instrument, which refers to performing real-time comparative analysis on the first status information of the surgical instrument before use and the second status information of the surgical instrument at any time when the surgical instrument is used.

[0150] For example, taking the status information as digital image information, the first status information is the complete digital image information of the surgical instrument before the operation, and the second status information is the digital image information of the surgical instrument acquired by the data acquisition module at time A during the operation; wherein time A is any time during the operation; the real-time monitoring module compares and analyzes the complete digital image information before the operation with the digital image information acquired by the data acquisition module at time A.

[0151] When the first state information is the same as the second state information, it can be determined that the current state of the catheter is in good condition, that is, there is no bending, twisting or rupture, and the ablation operation can continue; when the first state information is different from the second state information, that is, the catheter is bent, twisted or ruptured, at this time, the real-time monitoring module displays an instruction to stop the operation.

[0152] The second type of status information is second status information of at least two arbitrary moments when the surgical instrument is in use.

[0153] Based on this, the real-time monitoring module performs real-time comparative analysis on the state information of the surgical instrument, which means performing real-time comparative analysis on the second state information at at least two arbitrary moments when the surgical instrument is used.

[0154] For example: taking the status information as digital image information, the second status information at at least two arbitrary moments include the digital image information of the surgical instrument acquired by the data acquisition module at time A and time B during the operation, wherein time A is different from time B, and time A and time B can be any moments during the operation; the real-time monitoring module compares and analyzes the digital image information acquired at time A with the digital image information acquired at time B.

[0155] When the second state information at different times is the same, it can be determined that the current state of the catheter is in good condition, that is, there is no bending, twisting or rupture, and the ablation operation can continue; when the second state information at different times is different, that is, the catheter is bent, twisted or ruptured, at this time, the real-time monitoring module displays an instruction to stop the operation.

[0156] Step 1303: In case of safety hazards in surgical instruments, a command to stop the surgery is issued.

[0157] Since the safety monitoring method provided in the above embodiment and the safety monitoring system embodiment belong to the same concept, the specific implementation process is detailed in the system embodiment and will not be repeated here.

[0158] To summarize, the safety monitoring method provided in the present embodiment obtains the first state information and the second state information of the surgical instrument, and / or the second state information at at least two arbitrary moments; compares the first state information and the second state information, and / or the two second state information, to determine whether the surgical instrument has a safety hazard; and issues a command to stop the operation when the surgical instrument has a safety hazard; it can solve the safety problem caused by the difficulty in detecting when the surgical instrument is broken; because the second state information will change when the surgical instrument is broken or bent or twisted, by comparing and analyzing the first state information and the second state information of the surgical instrument, it can be discovered in time that the surgical instrument is broken or bent or twisted, thereby protecting the patient's life.

[0159] This embodiment provides a safety monitoring device for surgical instruments, such as Fig.14 The device includes at least the following modules: a state information acquisition module 1410 , a state information comparison module 1420 and a stop instruction issuing module 1430 .

[0160] The state information acquisition module 1410 is used to acquire the first state information and the second state information of the surgical instrument, and / or the second state information at at least two arbitrary moments;

[0161] The state information comparison module 1420 is used to compare the first state information and the second state information, and / or the two second state information, to determine whether there is a safety hazard in the surgical instrument;

[0162] The stop instruction issuing module 1430 is used to issue a surgery stop instruction when a safety hazard occurs to the surgical instrument.

[0163] For relevant details, refer to the above method and system embodiments.

[0164] It should be noted that: the safety monitoring device for surgical instruments provided in the above embodiments is only illustrated by the division of the above functional modules when performing medical catheter monitoring. In actual applications, the above functional distribution can be completed by different functional modules as needed, that is, the internal structure of the safety monitoring device for surgical instruments is divided into different functional modules to complete all or part of the functions described above. In addition, the safety monitoring device for surgical instruments provided in the above embodiments and the safety monitoring method embodiment for surgical instruments belong to the same concept, and the specific implementation process is detailed in the method embodiment, which will not be repeated here.

[0165] This embodiment provides an electronic device, such as Fig.15 The electronic device at least includes a processor 1501 and a memory 1502.

[0166] Processor 1501 may include one or more processing cores, such as a 4-core processor, an 8-core processor, etc. Processor 1501 may be implemented in at least one hardware form of DSP (Digital Signal Processing), FPGA (Field-Programmable Gate Array), and PLA (Programmable Logic Array). Processor 1601 may also include a main processor and a coprocessor. The main processor is a processor for processing data in the awake state, also known as a CPU (Central Processing Unit); the coprocessor is a low-power processor for processing data in the standby state. In some embodiments, processor 1501 may be integrated with a GPU (Graphics Processing Unit), which is responsible for rendering and drawing the content to be displayed on the display screen. In some embodiments, processor 1501 may also include an AI (Artificial Intelligence) processor, which is used to process computing operations related to machine learning.

[0167] The memory 1502 may include one or more computer-readable storage media, which may be non-transitory. The memory 1502 may also include a high-speed random access memory, and a non-volatile memory, such as one or more disk storage devices, flash memory storage devices. In some embodiments, the non-transitory computer-readable storage medium in the memory 1502 is used to store at least one instruction, which is used to be executed by the processor 1501 to implement the safety monitoring method of the surgical instrument provided in the method embodiment of the present application.

[0168] In some embodiments, the electronic device may further optionally include: a peripheral device interface and at least one peripheral device. The processor 1501, the memory 1502 and the peripheral device interface may be connected via a bus or a signal line. Each peripheral device may be connected to the peripheral device interface via a bus, a signal line or a circuit board. Schematically, the peripheral devices include but are not limited to: a radio frequency circuit, a touch display screen, an audio circuit, and a power supply.

[0169] Of course, the electronic device may also include fewer or more components, which is not limited in this embodiment.

[0170] Optionally, the present application also provides a computer-readable storage medium, in which a program is stored, and the program is loaded and executed by a processor to implement the safety monitoring method of surgical instruments in the above method embodiment.

[0171] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0172] Obviously, the embodiments described above are only some embodiments of the present application, rather than all embodiments. Based on the embodiments in the present application, ordinary technicians in this field can make other different forms of changes or modifications without making creative work, which should all fall within the scope of protection of the present application.

Claims

1. A safety monitoring system for surgical instruments, characterized in that: The system includes surgical instruments, a digital imaging module, a data acquisition module and a real-time monitoring module; The surgical instrument is used to intervene in a lesion area; the surgical instrument comprises a catheter fixing component and a catheter, wherein the catheter fixing component is connected to the proximal end of the catheter; a monitoring component is provided on the surgical instrument, wherein the monitoring component is provided on the catheter and / or the catheter fixing component, and is used to indicate the real-time status of the surgical instrument and generate digital image information; the monitoring component further comprises a membrane layer structure, wherein the membrane layer structure comprises a visualization enhancement membrane, and the visualization enhancement membrane is provided on the outer wall of the catheter; The digital imaging module is used to acquire at least one medical digital imaging data of the surgical instrument and / or the monitoring component in real time, wherein the medical digital imaging data includes the digital imaging information; The data acquisition module is connected to the digital imaging module, and is used to continuously receive status information of the surgical instrument and / or receive real-time status information of the surgical instrument acquired by the monitoring component, wherein the status information at least includes: first status information of the surgical instrument before use and second status information of the surgical instrument at any time when the surgical instrument is used, and second status information of at least two arbitrary times when the surgical instrument is used; the status information includes the medical digital imaging data; The real-time monitoring module is used to obtain the safety status indication information of the surgical instrument by performing real-time comparative analysis on the first status information and the second status information, and performing real-time comparative analysis on the second status information at at least two arbitrary moments; The real-time monitoring module outputs safety alarm information according to the safety status indication information.

2. A safety monitoring system according to claim 1, characterized in that: The state information includes at least one of the following: digital image information, electrical signal, ultrasonic signal, and optical signal.

3. A safety monitoring system according to claim 1, characterized in that: The digital imaging module is used to acquire at least one medical digital imaging data of the lesion area and / or the surgical instrument and / or the monitoring component in real time.

4. A safety monitoring system according to claim 1, characterized in that: The monitoring component comprises a plurality of storage slots, wherein the storage slots are embedded in the tube wall of the conduit and are filled with developer.

5. A safety monitoring system according to any one of claims 1 or 4, characterized in that: The catheter comprises a coaxially arranged energy transmission component, an inner tube and an outer tube; the inner tube is sleeved on the outer side of the energy transmission component, and the outer tube is sleeved on the outer side of the inner tube.

6. A safety monitoring system according to claim 5, characterized in that: A water inlet cavity is provided between the inner tube and the energy transmission component, and the water inlet cavity is used for the cooling medium to flow in or out; a water return cavity is provided between the inner tube and the outer tube, and the water return cavity is used for the cooling medium to flow out or in.

7. A safety monitoring system according to claim 6, characterized in that: The outer wall of the outer tube is provided with a membrane layer structure, and the membrane layer structure comprises an anti-cracking protection film and / or a visualization enhancement film and / or a hydrophilic film.

8. A safety monitoring system according to claim 1, characterized in that: The monitoring component also includes a conductive element and a circuit system; the conductive element is arranged on the surgical instrument, the conductive element is connected to the circuit system, and the circuit system is used to obtain electrical signals at any time in real time.

9. A safety monitoring system according to claim 8, characterized in that: The circuit system is connected to the real-time monitoring module, and the real-time monitoring module is used to analyze the electrical signal at any time in real time and generate safety status indication information of the surgical instrument; the real-time monitoring module outputs safety alarm information according to the safety status indication information.

10. A safety monitoring system according to claim 1, characterized in that: The monitoring component also includes an ultrasonic generator and an ultrasonic receiver; the ultrasonic generator is used to generate ultrasonic waves propagating along the catheter; and the ultrasonic receiver is used to receive reflected ultrasonic waves.

11. A safety monitoring system according to claim 10, characterized in that: The safety monitoring system also includes a control unit, which is connected to the real-time monitoring module; The real-time monitoring module is used to analyze the ultrasonic signal at any time in real time and generate safety status indication information of the surgical instrument; the real-time monitoring module outputs safety alarm information according to the safety status indication information.

Images