Magnetic navigation intraoperative ultrasonic probe and puncture system

Abstract

The invention provides a magnetic navigation intraoperative ultrasonic probe and a puncture system, and relates to the technical field of medical equipment, the magnetic navigation intraoperative ultrasonic probe comprises a sound head part, a bending part and a handle shell part which are sequentially connected from the far end to the near end of the probe, and a probe cable and a magnetic navigation sensor assembly; the sound head part is located at the farthest end of the probe, the sound head part comprises an emission sound window, and the inner wall of the sound head part is provided with an installation groove position used for fixedly installing the magnetic navigation sensor assembly; the magnetic navigation sensor assembly comprises a magnetic navigation sensor body and a sensor cable, the magnetic navigation sensor body is fixed to the mounting slot position so that the relative position of the magnetic navigation sensor body and the emission acoustic window can not be changed, and the sensor cable is connected to the near end of the magnetic navigation sensor body and extends towards the near end of the probe in the probe. The problems that in the prior art, after an intraoperative ultrasonic probe and a magnetic navigation sensor are combined, use is limited, a line is prone to being broken, the operation cost is high, and efficiency is low are solved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and more particularly, to a magnetic navigation intraoperative ultrasound probe and a puncture system. Background Art

[0002] With the deep integration of ultrasound technology and laparoscopic technology, laparoscopic ultrasound (LUS) has emerged. With its high-resolution imaging advantages, LUS can accurately identify small satellite lesions and metastatic lesions, clearly mark important duct structures, accurately determine the surgical margin, and guide the puncture operation in real time, effectively making up for the visual blind spots in traditional laparoscopic liver surgery, and thus is hailed as the "third eye" by the surgical community.

[0003] Compared with the puncture technique under open abdominal ultrasound guidance, there are significant differences in laparoscopic ultrasound-guided puncture. Specifically, laparoscopic ultrasound-guided puncture neither uses a dedicated puncture rack and precise guiding wire system nor a special puncture needle. In clinical practice, surgeons usually choose an 18G PTC needle for puncture, but the length of this needle is insufficient for puncture in some liver segments. In addition, the puncture operation is restricted by many factors: the surgeon has to rely entirely on manual operation, and both the puncture direction and the needle insertion angle are strictly restricted.

[0004] To ensure clear display of the needle tip, when performing intrahepatic portal vein puncture under LUS guidance, the needle insertion direction from the foot side to the head side is preferably selected. The specific operation points include: accurately determining the puncture point on the liver surface according to the probe position, the depth of the target duct, and the angle relationship between the puncture needle and the probe. During the needle insertion process, the probe position needs to be dynamically adjusted: first, retract the probe to clearly display the needle tip, and then adjust the probe position in real time according to the needle insertion depth, and monitor the needle tip movement throughout the process to avoid damaging important duct structures. When the needle tip approaches the portal vein of the target liver segment, the needle tip and the target hepatic pedicle can be simultaneously displayed by slightly axially rotating the probe. At this time, the spatial position relationship between the two can be accurately judged, and then it can be determined whether the needle tip can safely enter the portal vein of the target liver segment.

[0005] In most cases, the liver image displayed by the LUS probe is an oblique section. By rotating the probe axially clockwise or counterclockwise, the scanning plane can move to the right foot side or the left head side respectively. The surgeon can dynamically adjust the needle insertion direction according to the change of the probe orientation and the relative position relationship between the needle tip and the target portal vein. If the needle tip significantly deviates from the target portal vein, the needle needs to be withdrawn and the puncture point on the liver surface needs to be reselected. Through repeated adjustment and correction, the target portal vein can be accurately punctured finally.

[0006] At present, in laparoscopic ultrasound-guided puncture surgery, in order to more accurately determine the position of the puncture kit, the applicant proposed a technology of sleeving and fixing a magnetic navigation sensor on the external part of the intraoperative ultrasound probe. However, there are still some deficiencies in the actual use of this technology: 1. The external sleeved buckle will cause an increase in the outer diameter of the probe insertion end. Although the influence of the increased probe insertion end can be reduced by thinning the buckle thickness, the process of thinning the buckle is difficult. In addition, the increase in the probe outer diameter is still limited for its clinical use (such as smoothly passing through the trocar); 2. Due to the external placement of the magnetic navigation sensor, there is still a risk of damage or even disconnection of the magnetic navigation sensor during use; 3. The externally sleeved buckle and the magnetic navigation sensor are consumables, and separate disinfection and sterilization operations are required during each clinical use. Moreover, due to the large operation difficulty in the installation and disassembly of the external buckle, and even special disassembly and assembly tools are needed, resulting in high surgical costs and low efficiency. Summary of the Invention

[0007] The purpose of this application is to provide a magnetic navigation intraoperative ultrasound probe and a puncture system, aiming to solve the problems of limited use, easy disconnection, high surgical costs, and low efficiency existing after combining the intraoperative ultrasound probe with the magnetic navigation sensor in related technologies.

[0008] The additional aspects and advantages of this application will be partially described below, and partially will become apparent from the description, or can be learned through the practice of this application.

[0009] According to the first aspect of this application, a magnetic navigation intraoperative ultrasound probe is provided, which includes an acoustic head, a bending part, and a handle housing part connected in sequence from the distal end to the proximal end of the probe, as well as a probe cable and a magnetic navigation sensor assembly; The acoustic head is located at the farthest distal end of the probe. The acoustic head includes a transmitting acoustic window, and an installation slot for fixedly installing the magnetic navigation sensor assembly is provided on the inner wall of the acoustic head; The magnetic navigation sensor assembly includes a magnetic navigation sensor body and a sensor cable. The magnetic navigation sensor body is fixed in the installation slot so that the relative position of the magnetic navigation sensor body and the transmitting acoustic window remains unchanged. The sensor cable is connected to the proximal end of the magnetic navigation sensor body and extends proximally inside the probe.

[0010] In an exemplary embodiment of this application, the magnetic navigation sensor assembly further includes a positioning part. A positioning slot is provided on the positioning part, and the magnetic navigation sensor body is fixed in the positioning slot. The positioning part is used for fixedly connecting to the installation slot.

[0011] In an exemplary embodiment of this application, the installation slot is provided on the inner wall of the acoustic head directly below the center of the transmitting acoustic window.

[0012] In an exemplary embodiment of the present application, the magnetic navigation sensor assembly further includes a signal processor, which is configured to amplify the sensor signals collected by the magnetic navigation sensor body and / or convert the sensor signals collected by the magnetic navigation sensor body into digital signals and then transmit them to the navigation device; the signal processor is located in the acoustic head, and the signal processor is connected between the magnetic navigation sensor body and the sensor cable.

[0013] In an exemplary embodiment of the present application, the probe cable includes an ultrasonic working cable and a reserved connection cable. The sensor cable is located in the acoustic head. One end of the sensor cable is connected to the proximal end of the magnetic navigation sensor body, and the other end is connected to the distal end of the reserved connection cable. The ultrasonic working cable and the reserved connection cable form an integrated wire harness. The probe cable extends from the distal end to the proximal end of the probe, passes through the bending part, and extends towards the handle housing part.

[0014] In an exemplary embodiment of the present application, after the integrated wire harness formed by the ultrasonic working cable and the reserved connection cable passes out of the proximal end of the handle housing part, it is split into two bundles of cables again. Among them, the reserved connection cable is used to connect the navigation device, and the ultrasonic working cable is used to connect the ultrasonic device.

[0015] In an exemplary embodiment of the present application, the sensor cable and the probe cable are two independent wire harnesses. Both of the two wire harnesses extend from the distal end to the proximal end, pass through the bending part, and extend towards the handle housing part; The distal end of the sensor cable is fixed to the magnetic navigation sensor body, the proximal end of the sensor cable is relatively fixed to the handle housing part, and a redundant section is provided in the middle section between the distal end and the proximal end of the sensor cable. The redundant section can conform to the bending deformation of the bending part when the bending part of the probe is bent, and displace back and forth along the extending direction of the sensor cable to protect the sensor cable.

[0016] In an exemplary embodiment of the present application, it further includes a guiding column with a smooth surface. The guiding column is fixedly arranged in the acoustic head or the handle housing part along the length direction of the probe, and the redundant section is movably wound around the guiding column in a spiral manner.

[0017] In an exemplary embodiment of the present application, it further includes a hollow sensor wire harness protection tube. The sensor wire harness protection tube is made of elastic or soft material. The sensor wire harness protection tube includes a connecting tube section and a spiral tube section. The distal end of the connecting tube section extends to the acoustic head and is relatively fixed to the magnetic navigation sensor body. The proximal end of the connecting tube section passes through the bending part and is connected to the distal end of the spiral tube section located in the handle housing part. The spiral tube section is movably sleeved on the wire harness of the probe cable; the sensing cable is disposed inside the connecting tube section and the spiral tube section, and the redundant section extends in the spiral tube section in a spiral manner.

[0018] According to a second aspect of the present application, there is provided a puncture system, including the magnetic navigation intraoperative ultrasound probe, the puncture kit, the navigation device, and the ultrasound device described in any one of the above. A second magnetic navigation sensor assembly is provided on the puncture kit. The sensor cable is connected to the navigation device after passing out of the handle housing part, and the probe cable is connected to the ultrasound device after passing out of the handle housing part; The navigation device is configured to be able to extract the electromagnetic signals received by the magnetic navigation sensor assembly and the second magnetic navigation sensor assembly, and determine the positional relationship between the puncture kit and the intraoperative ultrasound probe based on the electromagnetic signals.

[0019] The exemplary embodiments of the present application may have some or all of the following beneficial effects: 1. In the magnetic navigation intraoperative ultrasound probe provided by the exemplary embodiment of the present application, by disposing the magnetic navigation sensor assembly inside the probe and fixing the magnetic navigation sensor body of the magnetic navigation sensor assembly at the installation slot inside the acoustic head, after the probe enters the human body, the position of the intraoperative ultrasound probe can be obtained based on the coordinate position of the magnetic navigation sensor body in the navigation device system, which provides convenience for medical staff to perform puncture operations. Installing the magnetic navigation sensor body inside makes rational use of the internal space of the probe by the magnetic navigation sensor body, so the outer diameter of the insertion end of the probe will not be increased, and thus the probe is not easily restricted during clinical use. Moreover, by installing the magnetic navigation sensor inside the probe, the magnetic navigation sensor assembly can be protected by the acoustic head, the bending part, and the handle housing part, making the magnetic navigation sensor assembly not easily damaged. In addition, by installing the magnetic navigation sensor assembly inside the probe, there is no need to use an externally sleeved buckle. Each time the medical staff only needs to disinfect the outer surface of the probe, without disassembly, thus reducing the operation difficulty of the medical staff and eliminating the need for special disassembly and assembly tools, thereby reducing the high surgical cost and improving the surgical efficiency; 2. In the magnetic navigation ultrasound probe provided in the exemplary embodiment of the present application, the mounting slot is set just below the transmitting acoustic window, so that the magnetic navigation sensor body is located just below the transmitting acoustic window, thereby improving the convenience of calibrating the position of the magnetic navigation sensor assembly and the positioning accuracy; 3. In the magnetic navigation ultrasound probe provided in the exemplary embodiment of the present application, the sensor signal collected by the magnetic navigation sensor body is amplified and / or converted into a digital signal by a signal processor, and then transmitted to the navigation device to reduce the influence of interference on the signal during transmission; 4. In the magnetic navigation ultrasound probe provided in the exemplary embodiment of the present application, the sensor cable is connected to the reserved connection cable, so that the magnetic navigation sensor body can transmit signals through the reserved connection cable, and the ultrasound working cable and the reserved connection cable form an integrated wiring harness during the transmission process. On the one hand, the separate wiring of the sensor cable is omitted, saving costs; on the other hand, the probe cable is thicker and has stronger resistance to pulling. The sensor cable is transmitted to the proximal end of the probe by using the probe cable, which can further reduce the risk of damage to the sensor cable or even disconnection when the bending portion is bent; 5. In the magnetic navigation ultrasound probe provided in the exemplary embodiment of the present application, the sensor cable and the probe cable are two independent bundles of cables, which can achieve a better isolation effect between signals and reduce mutual interference between signals; 6. In the magnetic navigation ultrasound probe provided in the exemplary embodiment of the present application, when the sensor cable and the probe cable are two independent cable bundles, the sensor cable is provided with a redundant section, and when the bending portion is bent or straightened, the redundant section of the sensor cable can be adaptively deformed, so that the sensor cable is not easily damaged; 7. In the magnetic navigation ultrasound probe provided in the exemplary embodiment of the present application, when the sensor cable and the probe cable are two independent wire harnesses, the redundant section of the sensor cable is wound around a smooth guide column. When the bending portion is bent, the sensor cable can extend along the guide column. When the bending portion returns to its initial state, the redundant section of the sensor cable can also shrink by itself. The guide column guides the extension and shrinkage of the redundant section of the sensor cable, so that the sensor cable is not likely to shrink and bend too small and cause damage due to lack of guidance. 8. In a magnetic navigation ultrasound probe provided in an example embodiment of the present application, when the sensor cable and the probe cable are two independent cables, the sensor cable is inserted into a sensor wire harness protection tube. When the bending portion bends, the spiral tube section of the sensor wire harness protection tube can drive the sensor cable to stretch along the length direction of the probe cable, thereby protecting the sensor cable through the sensor wire harness protection tube.

[0020] It should be understood that the above general description and the following detailed description are merely exemplary and explanatory, and should not limit this application. Brief Description of the Drawings

[0021] The accompanying drawings herein are incorporated into the specification and form a part of this specification, showing embodiments consistent with this application, and are used together with the specification to explain the principles of this application. Obviously, the accompanying drawings in the following description are only some embodiments of this application, and those of ordinary skill in the art can obtain other drawings based on these drawings without creative efforts.

[0022] Figure 1 Shows a schematic structural diagram of an ultrasonic probe in Embodiment 1 of this application; Figure 2 Shows a schematic diagram of the bending part before and after bending and the structure of the insertion tube layer in Embodiment 1 of this application; Figure 3 Shows a schematic structural diagram of the acoustic head in Embodiment 1 of this application; Figure 4 Shows a schematic structural diagram of the integrated wire harness in Embodiment 1 of this application; Figure 5 Shows a schematic diagram of a double-cable structure with a guiding column in Embodiment 1 of this application; Figure 6 Shows a schematic diagram of a double-cable structure with a sensor wire harness protection tube in Embodiment 1 of this application.

[0023] Description of the Reference Numerals in the Drawings: 1. Acoustic head; 11. Transmitting acoustic window; 111. Matching layer; 112. Piezoelectric crystal; 113. Backing; 2. Bending part; 3. Handle housing part; 31. Insertion tube; 32. Handle end; 4. Magnetic navigation sensor assembly; 41. Magnetic navigation sensor body; 42. Sensor cable; 43. Positioning member; 44. Signal processor; 5. Probe cable; 51. Ultrasonic working cable; 52. Reserved connection cable; 6. Guiding column; 7. Sensor wire harness protection tube; 71. Connecting pipe section; 72. Spiral pipe section. Detailed Embodiments

[0024] Example embodiments will now be described more fully with reference to the accompanying drawings. However, the example embodiments can be implemented in various forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the concept of the example embodiments to those skilled in the art. Like reference numerals in the drawings denote the same or similar structures, and thus their detailed descriptions will be omitted. In addition, the drawings are only schematic illustrations of this application and are not necessarily drawn to scale.

[0025] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of an icon to another component, these terms are used in this specification only for convenience, for example, according to the direction of the example in the drawings. It can be understood that if the device of the icon is turned upside down, the component described as "upper" will become the component described as "lower". When a structure is "on" another structure, it may mean that a structure is integrally formed on another structure, or that a structure is "directly" disposed on another structure, or that a structure is "indirectly" disposed on another structure through another structure.

[0026] The terms "a", "an", "the", and "at least one" are used to denote the presence of one or more elements / components / etc.; the terms "comprising" and "having" are used to mean an open inclusion and mean that there may be additional elements / components / etc. in addition to the listed elements / components / etc.; the terms "first", "second" are used only as labels and are not a limitation on the quantity of their objects. Embodiment 1

[0027] Referring to Figure 1 As shown, an ultrasonic probe in magnetic navigation surgery provided by an embodiment of the present invention includes a sound head 1, a bending part 2, and a handle housing part 3 connected in sequence from the distal end to the proximal end of the probe, as well as a probe cable 5 and a magnetic navigation sensor assembly 4; the handle housing part 3 further includes an insertion tube 31 and a handle end 32. The distal end of the sound head 1 is connected to the distal end of the bending part 2 through a rigid joint part. The distal end of the insertion tube 31 is connected to the proximal end of the bending part 2, and the handle end 32 is disposed at the proximal end of the insertion tube 31. In the embodiment of the present application, the bending part 2 is made of a snake bone tube. Of course, this is not restrictive. The snake bone tube has good plasticity and can restore to its initial shape through its own structure and internal wire control after bending deformation. During use, the operator can realize the bending of the bending part 2 driving the sound head 1 forward, backward, left, and right by operating the handle of the handle end 32.

[0028] Referring to Figure 1 and Figure 2 As shown, further, the insertion tube 31 in the handle housing part 3 is sequentially provided with a polyurethane outer layer 311, a tungsten wire braided outer layer 312, a polyurethane inner layer 313, a tungsten wire braided inner layer 314, and a steel stranded wire tube 315 from the outside to the inside, which can play a good role in protecting the signal transmission of the magnetic navigation sensor assembly 4 and can reduce the interference of the external environment on the signal transmission.

[0029] Referring to Figures 1-6 As shown, furthermore, the sound head 1 is located at the outermost distal end of the probe. The sound head 1 includes a transmitting sound window 11, and the transmitting sound window 11 includes a matching layer 111, a piezoelectric crystal 112, and a backing 113 (such as Figure 3), an installation slot for fixedly mounting the magnetic navigation sensor assembly 4 is provided on the inner wall of the acoustic head 1. The magnetic navigation sensor assembly 4 includes a magnetic navigation sensor body 41 and a sensor cable 42. The magnetic navigation sensor body 41 is fixed in the installation slot so that the relative position between the magnetic navigation sensor body 41 and the transmitting acoustic window 11 remains unchanged. The sensor cable 42 is connected to the proximal end of the magnetic navigation sensor body 41 and extends towards the proximal end of the probe inside the probe. During use, the ultrasonic probe is used to emit ultrasonic waves, and the ultrasonic waves pass through the transmitting acoustic window 11. The magnetic navigation sensor body 41 is fixedly installed through the installation slot. On the one hand, it can ensure that the magnetic navigation sensor assembly 4 maintains good stability; on the other hand, it can maintain the relative position between the transmitting acoustic window 11 and the magnetic navigation sensor assembly 4 constant, thereby ensuring the accuracy of signal acquisition. After the acquisition work is completed, the signal will be transmitted through the sensor cable 42.

[0030] In the embodiment of the present application, the magnetic navigation sensor assembly 4 adopts an in-built design and is integrated inside the probe. Compared with the solution of an external magnetic navigation sensor, this design has the following significant advantages: 1. Enhanced protection performance: The acoustic head 1, the bending part 2 and the handle housing part 3 together form a protection structure, effectively reducing the risk of damage to the magnetic navigation sensor assembly 4 during use; 2. Improved anti-interference ability: The in-built layout can greatly reduce the interference of the external environment on the signal acquisition of the magnetic navigation sensor body 41 and the signal transmission of the sensor cable 42, thereby improving the stability and reliability of intraoperative data; 3. Compact structure and wider applicability: By optimizing the utilization rate of the internal space of the probe, this design can ensure the complete function without increasing the outer diameter of the insertion end of the probe. Therefore, the probe is not easily restricted during clinical use, broadening the scope of clinical applications; 4. Good sealing and easy disinfection: Since the magnetic navigation sensor assembly 4 is completely built inside the probe and no external buckles are required, the probe has excellent sealing performance and can effectively block the penetration of human tissue fluid or blood. After the operation, only the surface of the probe needs to be routinely disinfected without disassembly, simplifying the disinfection process of medical staff, reducing the operation cost and improving the operation efficiency.

[0031] In the embodiment of the present application, the magnetic navigation sensor body 41 can be a coil, a magnetoresistive sensor (for example: giant magnetoresistive sensor AMR, tunneling magnetoresistive sensor TMR), or a combination of a sensor and a circuit. Of course, the above are only exemplary descriptions and not restrictive.

[0032] In the embodiment of the present application, the magnetic navigation sensor assembly 4 further includes a positioning member 43. A positioning groove is formed on the positioning member 43, and the magnetic navigation sensor body 41 is fixed in the positioning groove. The positioning member 43 is used for fixedly connecting to the installation slot. Specifically, during installation, first insert the magnetic navigation sensor body 41 into the positioning groove to be fixed to the positioning member 43, and then fix the positioning member 43 and the magnetic navigation sensor body 41 at the installation slot. Subsequently, in order to enhance the firmness of its fixation, medical-grade epoxy resin glue can also be used for reinforcement, and reinforcement can be carried out by laser welding or other processes to ensure that there is no displacement risk when the probe bends during the operation (such as 180° rotation).

[0033] In the embodiment of the present application, in order to facilitate the calibration of the positional relationship between the magnetic navigation sensor body 41 and the transmitting acoustic window 11, the installation slot is arranged on the inner wall of the acoustic head 1 directly below the center of the transmitting acoustic window 11. Through this structure, it not only ensures that the magnetic navigation sensor body 41 and the transmitting acoustic window 11 maintain an accurate spatial correspondence relationship; at the same time, the operator can also complete the sensor positioning intuitively and quickly, avoiding the cumbersome repeated calibration process in the technology of a magnetic navigation sensor fixed by a buckle sleeved outside the intraoperative ultrasonic probe proposed by the applicant; thereby eliminating the positioning error that may be brought by manual operation.

[0034] In the embodiment of the present application, the magnetic navigation intraoperative ultrasonic probe further includes a signal processor 44. The signal processor 44 can be either a signal amplifier or a signal converter. When a signal amplifier is adopted, its function is to amplify the sensor signal collected by the magnetic navigation sensor body 41; when a signal converter is adopted, its function is to convert the sensor signal collected by the magnetic navigation sensor body 41 into a digital signal; of course, the signal processor 44 can also be a combination of a signal amplifier and a signal converter. After the signal processor 44 processes the sensor signal, it is transmitted to the navigation device.

[0035] Furthermore, the signal processor 44 is located in the acoustic head 1, and the signal processor 44 is connected between the magnetic navigation sensor body 41 and the sensor cable 42. Because the electrical signal initially converted by the magnetic navigation sensor body 41 is very weak, if directly transmitted, since the probe is relatively long, usually more than 2 meters, it is easily interfered. Therefore, the signal processor 44 is arranged between the magnetic navigation sensor body 41 and the sensor cable 42 because the magnetic navigation sensor body 41 can first amplify and / or convert after signal acquisition and then transmit it, thereby further reducing the interference during the transmission process.

[0036] In the present application, the magnetic navigation sensor body 41 and the signal processor 44 can either adopt a split structure or be integrated into one, and there is no limitation on this.

[0037] In one embodiment, the probe cable 5 includes an ultrasonic working cable 51 and a reserved connection cable 52. The sensor cable 42 is located within the acoustic head 1. One end of the sensor cable 42 is connected to the proximal end of the magnetic navigation sensor body 41, and the other end is connected to the distal end of the reserved connection cable 52. The connection between the two can be achieved by bundling, using a connector, or being an integral structure. Of course, this is not restrictive. The ultrasonic working cable 51 and the reserved connection cable 52 form an integral wire harness. The probe cable 5 extends from the distal end to the proximal end of the probe, passes through the bending portion 2, and extends towards the handle housing portion 3. Specifically, when selecting the probe cable 5, the number of inner cores of the cable can be selected to be more than the number of inner cores required for the ultrasonic probe. During use, only a part of the cable is used for ultrasonic transmission (this part of the cable is regarded as the ultrasonic working cable 51), and the cable not used for ultrasonic transmission is regarded as the reserved connection cable 52. The sensor cable 42 is connected to the reserved connection cable 52, so that the signals collected by the magnetic navigation sensor body 41 are transmitted through the probe cable 5. Since the probe cable 5 has strong tensile strength and flexibility, the bending portion 2 will not be damaged when being bent.

[0038] Referring to Figure 4 As shown, in this embodiment, after the integral wire harness formed by the ultrasonic working cable 51 and the reserved connection cable 52 passes out from the proximal end of the handle housing portion 3, it is split into two bundles of cables again. Among them, the reserved connection cable 52 is used to connect the navigation device, and the ultrasonic working cable 51 is used to connect the ultrasonic device. By splitting the ultrasonic working cable 51 and the reserved connection cable 52 after they pass out from the handle housing portion 3, it is convenient for them to be respectively connected to the navigation device and the ultrasonic device, and mutual interference is avoided. In other embodiments, after the integral wire harness formed by the ultrasonic working cable 51 and the reserved connection cable 52 passes out from the proximal end of the handle housing portion 3, it may not be split, but directly connect the navigation and ultrasonic devices through the integral wire harness. Therefore, when using an integral wire harness, the navigation and ultrasonic devices can be an integral structure.

[0039] Referring to Figure 5 and Figure 6 As shown, in another embodiment, a dual-cable independent layout is adopted, in which the sensor cable 42 and the probe cable 5 are spatially independent of each other. Both bundles of cables are arranged along the axial direction of the probe, and sequentially pass through the bending portion 2 from the distal end to the proximal end and extend to the handle housing portion 3. Specifically, the distal end of the sensor cable 42 is fixedly connected to the magnetic navigation sensor body 41, and the proximal end is fixed to the handle housing portion 3; a redundant section is provided in the middle section between the distal end and the proximal end of the sensor cable 42. The redundant section can conform to the bending deformation of the bending portion 2 of the probe when the bending portion 2 of the probe is bent, and displace back and forth along the extending direction of the sensor cable 42 to protect the sensor cable 42.

[0040] The sensor cable 42 and the probe cable 5 are transmitted independently, which can further reduce the signal interference between them. A redundant section is added according to the characteristics of the sensor cable 42 (the wire diameter is relatively thin and the tensile property is poor). When the bending part 2 is bent, the redundant section can dynamically adjust the cable allowance, ensuring that when the probe bends, the length of the sensor cable 42 can be compensated and the stress concentration can be eliminated, thus protecting the sensor cable 42 from being damaged easily and enabling the signal to be transmitted stably.

[0041] In this embodiment, to ensure the movement stability of the redundant section during the forward and backward displacement, the present application provides two guiding schemes. The specific content is as follows: Refer to Figure 5 As shown in the figure, Scheme 1: In this scheme, the ultrasonic probe in magnetic navigation also includes a guiding column 6 with a smooth surface. The guiding column 6 is arranged along the length direction of the probe. The guiding column 6 can be fixed in the sound head 1 or in the handle housing 3. When it is arranged in the handle housing 3, it can be located either in the insertion tube 31 or at the handle end 32. The redundant section is movably sleeved on the guiding column 6 in a spiral winding manner. When the bending part 2 bends, the redundant section is stretched on the guiding column 6 (manifested as an increase in the pitch, a decrease in the inner diameter of the redundant section, and an increase in the length of the redundant section) to provide length compensation for the bending part 2; when the bending part 2 returns to a straight state, the redundant section follows suit.

[0042] It can be understood that the closer the position of the guiding column 6 is to the bending part 2, the better the effect of length compensation for the bending part 2 during use. Therefore, it is the optimal scheme to set the guiding column 6 in the sound head 1. The guiding column 6 is located in the sound head 1, closest to the bending part 2, with the fastest compensation response and can achieve real-time and accurate length compensation. The sub-optimal alternative scheme (when there is insufficient space in the sound head 1) is to arrange it in the insertion tube 31 section, still maintaining good compensation timeliness, and the compensation effect is better than the distal arrangement scheme. The backup scheme (when the internal space of the sound head 1 is insufficient and the foregoing schemes are not feasible) is to arrange it at the handle end (the position space of the foregoing two schemes is severely insufficient), and there is a certain delay in the compensation response.

[0043] Refer to Figure 6 As shown in the figure, Scheme 2: In this solution, the ultrasonic probe in magnetic navigation also includes a hollow sensor harness protection tube 7, which is made of elastic or soft material. The sensor harness protection tube 7 includes a connecting tube section 71 and a spiral tube section 72. The distal end of the connecting tube section 71 extends to the acoustic head 1 and is relatively fixed to the magnetic navigation sensor body 41. The proximal end of the connecting tube section 71 passes through the curved portion 2 and is connected to the distal end of the spiral tube section 72 located at the handle shell 3. The spiral tube section 72 can be movably sleeved on a guide structure; the sensor cable is passed through the connecting tube section 71 and the spiral tube section 72, and the redundant section extends in the spiral tube section 72 in a spiral manner. In this application, a guide column seat extending along the length direction of the probe and fixedly arranged relative to the handle shell 3 can be set in the handle shell 3 as a guide structure; the harness of the probe cable 5 can also be directly used as a guide column, so that the spiral tube section 72 is wound around the probe cable 5.

[0044] Through this solution, the sensor cable 42 can be further shielded from external interference to prevent signal interference. At the same time, the sensor harness protection tube 7 also protects the sensor cable 42, making it less likely to be damaged when stretched. In this solution, when the curved portion 2 is bent, the spiral tube section 72 and the internal sensor cable 42 are stretched along the length direction of the probe cable 5 (manifested as an increase in the pitch of the spiral tube section 72, a decrease in the inner diameter, and an increase in the length of the spiral tube section 72), thereby achieving length compensation for the curved portion 2. When the curved portion 2 is restored to a straight state, the spiral tube section 72 and the sensor cable 42 are restored together.

[0045] In this solution, the connecting pipe section 71 is a straight pipe section, and the connecting pipe section 71 is arranged on one side of the probe cable 5. Through this structure, the bending portion 2 of the probe will not be affected when it moves, avoiding interference with the bending portion 2 when it bends, ensuring that the bending portion 2 can maintain the maximum bending angle, and maintaining the original flexibility and operability of the probe. Example 2

[0046] An embodiment of the present invention provides a puncture system, which includes any one of the magnetic navigation intraoperative ultrasound probes in Example 1, and also includes a puncture kit, a navigation device, and an ultrasound device.

[0047] In terms of structural connections: The puncture kit is provided with a second magnetic navigation sensor assembly 4, the sensor cable 42 passes through the handle shell part 3 and is connected to the navigation device, and the probe cable 5 passes through the handle shell part 3 and is connected to the ultrasound device.

[0048] The system works as follows: The navigation device is configured to extract the electromagnetic signals received by the magnetic navigation sensor assembly 4 and the second magnetic navigation sensor assembly 4, and determine the positional relationship between the puncture kit and the intraoperative ultrasound probe based on the electromagnetic signals.

[0049] Those skilled in the art will readily conceive of other embodiments of the present application after considering the specification and practicing the embodiments of the present application. The present application is intended to cover any variations, uses, or adaptations of the present application, which follow the general principles of the present application and include known common knowledge or conventional technical means in the technical field not claimed in the present application. The specification and embodiments are only to be considered as exemplary, and the true scope and spirit of the present application are pointed out by the appended claims.

Claims

1. An ultrasonic probe in magnetic navigation surgery, characterized in that, It includes a sound head, a bending part, and a handle housing part connected in sequence from the distal end to the proximal end of the probe, as well as a probe cable and a magnetic navigation sensor assembly; The sound head is located at the outermost distal end of the probe. The sound head includes a transmitting sound window, and an installation slot for fixedly installing the magnetic navigation sensor assembly is provided on the inner wall of the sound head; The magnetic navigation sensor assembly includes a magnetic navigation sensor body and a sensor cable. The magnetic navigation sensor body is fixed in the installation slot so that the relative position of the magnetic navigation sensor body and the transmitting sound window remains unchanged. The sensor cable is connected to the proximal end of the magnetic navigation sensor body and extends proximally inside the probe.

2. The ultrasonic probe in the magnetic navigation technique according to claim 1, characterized in that, The magnetic navigation sensor assembly further includes a positioning member. A positioning groove is provided on the positioning member, and the magnetic navigation sensor body is fixed in the positioning groove. The positioning member is used for fixedly connecting to the installation slot.

3. The ultrasonic probe in the magnetic navigation technology according to claim 1, characterized in that, The installation slot is provided on the inner wall of the sound head directly below the center of the transmitting sound window.

4. The ultrasonic probe in the magnetic navigation technique according to claim 1, characterized in that, The magnetic navigation sensor assembly further includes a signal processor. The signal processor is configured to amplify the sensor signal collected by the magnetic navigation sensor body and / or to convert the sensor signal collected by the magnetic navigation sensor body into a digital signal and then transmit it to the navigation device; the signal processor is located in the sound head, and the signal processor is connected between the magnetic navigation sensor body and the sensor cable.

5. The ultrasonic probe in the magnetic navigation technique according to claim 4, wherein The magnetic navigation sensor body and the signal processor are integrated into an integral structure.

6. The ultrasonic probe in magnetic navigation according to claim 4 or 5, characterized in that, The probe cable includes an ultrasonic working cable and a reserved connection cable. The sensor cable is located in the sound head. One end of the sensor cable is connected to the proximal end of the magnetic navigation sensor body, and the other end is connected to the distal end of the reserved connection cable. The ultrasonic working cable and the reserved connection cable form an integral wire harness, which extends through the bending part in the direction from the distal end to the proximal end of the probe and extends towards the handle housing part.

7. The ultrasonic probe in the magnetic navigation technique according to claim 6, characterized in that After the integral wire harness formed by the ultrasonic working cable and the reserved connection cable passes out from the proximal end of the handle housing part, it is split into two bundles of cables again. Among them, the reserved connection cable is used to connect the navigation device, and the ultrasonic working cable is used to connect the ultrasonic device; Alternatively, after the integral wire harness formed by the ultrasonic working cable and the reserved connection cable passes out from the proximal end of the handle housing part, it is not split any more, and the integral wire harness is used to connect the navigation and ultrasonic devices.

8. The ultrasonic probe in the magnetic navigation technique according to claim 1, characterized in that The sensor cable and the probe cable are two independent wire harnesses. Both of the two wire harnesses extend through the bending part in the direction from the distal end to the proximal end and extend towards the handle housing part; The distal end of the sensor cable is fixed to the magnetic navigation sensor body, the proximal end of the sensor cable is relatively fixed to the handle housing part, and a redundant section is provided in the middle section between the distal end and the proximal end of the sensor cable. The redundant section can conform to the bending deformation of the bending part of the probe and displace back and forth along the extending direction of the sensor cable to protect the sensor cable when the bending part of the probe is bent.

9. The ultrasonic probe in magnetic navigation according to claim 8, wherein It further includes a guide post with a smooth surface, which is fixedly arranged in the acoustic head or the handle housing along the length direction of the probe, and the redundant section is movably wound around the guide post in a spiral manner.

10. The ultrasonic probe in the magnetic navigation technique according to claim 8, wherein, It further includes a hollow sensor wire harness protection tube, which is made of elastic or soft material. The sensor wire harness protection tube includes a connecting tube section and a spiral tube section. The distal end of the connecting tube section extends to the acoustic head and is relatively fixed to the magnetic navigation sensor body. The proximal end of the connecting tube section passes through the bending part and is connected to the distal end of the spiral tube section located in the handle housing. The spiral tube section is movably sleeved on a guiding structure; the sensing cable is arranged inside the connecting tube section and the spiral tube section, and the redundant section extends in the spiral tube section in a spiral manner.

11. The ultrasonic probe in the magnetic navigation technique according to claim 10, characterized in that, The guiding structure is a guide post extending along the length direction of the probe and relatively fixedly arranged with the handle housing; alternatively, the guiding structure is the wire harness of the probe cable.

12. A puncture system, characterized in that, It includes the magnetic navigation intraoperative ultrasound probe, the puncture kit, the navigation device and the ultrasound device according to any one of claims 1-11. A second magnetic navigation sensor assembly is arranged on the puncture kit. The sensor cable is connected to the navigation device after passing out of the handle housing, and the probe cable is connected to the ultrasound device after passing out of the handle housing; The navigation device is configured to be able to extract the electromagnetic signals received by the magnetic navigation sensor assembly and the second magnetic navigation sensor assembly, and determine the positional relationship between the puncture kit and the intraoperative ultrasound probe based on the electromagnetic signals.

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