Magnetic navigation intraoperative ultrasound probe and puncture system

Abstract

The present application provides a magnetic navigation intraoperative ultrasound probe and puncture system, relating to the field of medical device technology. The system comprises an acoustic head, a curved portion, and a handle housing, connected sequentially 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 end of the probe and includes an acoustic emission window. The inner wall of the acoustic head is provided with a mounting slot for fixedly mounting 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 in the mounting slot to maintain the relative position of the magnetic navigation sensor body and the acoustic emission window. The sensor cable is connected to the proximal end of the magnetic navigation sensor body and extends from the interior of the probe toward the proximal end of the probe. The system solves the problems of limited use, easy disconnection, high surgical costs, and low efficiency that exist in the related art when combining an intraoperative ultrasound probe with a magnetic navigation sensor.

Description

Technical Field

[0001] The present application relates to the technical field of medical equipment, and in particular to an ultrasound probe and puncture system for magnetic navigation surgery. Background Art

[0002] The deep integration of ultrasound and laparoscopic techniques has led to the emergence of laparoscopic ultrasound (LUS). Leveraging its high-resolution imaging capabilities, LUS can precisely identify microsatellite lesions and metastases, clearly mark important ductal structures, accurately determine surgical margins, and provide real-time guidance for puncture procedures. This effectively addresses the visual blind spots of traditional laparoscopic liver surgery, earning it the nickname "the third eye" in the surgical community.

[0003] Compared with the puncture technique under open ultrasound guidance, there are significant differences in laparoscopic ultrasound-guided puncture. Specifically, laparoscopic ultrasound-guided puncture does not use a dedicated puncture frame and precise guide wire system, nor does it use a special puncture needle. In clinical operation, the surgeon usually chooses an 18G PTC needle for puncture, but the length of this needle is insufficient for puncturing certain liver segments. In addition, the puncture operation is subject to many restrictions: the surgeon needs to rely entirely on manual operation, and the puncture direction and needle insertion angle are strictly restricted.

[0004] To ensure a 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 preferred. Specific operating points include: accurately determining the puncture point on the liver surface based on the probe position, the depth of the target channel, and the angle between the puncture needle and the probe. The probe position needs to be dynamically adjusted during the needle insertion process: 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 direction of the needle tip throughout the process to avoid damaging important channel structures. When the needle tip approaches the target liver segment portal vein, the needle tip and the target liver pedicle can be displayed simultaneously by slightly rotating the probe axially. 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 target liver segment portal vein.

[0005] In most cases, the LUS probe displays an oblique image of the liver. By rotating the probe axially clockwise or counterclockwise, the scanning plane can be shifted toward the right foot or left head, respectively. The surgeon can dynamically adjust the needle insertion direction based on the changes in probe orientation and the relative position of the needle tip to the target portal vein. If the needle tip significantly deviates from the target portal vein, the needle must be withdrawn and a new puncture point on the liver surface must be selected. Through repeated adjustments and corrections, the target portal vein is ultimately accurately penetrated.

[0006] At present, in laparoscopic ultrasound-guided puncture surgery, in order to more accurately determine the position of the puncture kit, the applicant has proposed a technology for fixing a magnetic navigation sensor with a buckle on the outside of the ultrasound probe during surgery. However, this technology still has some shortcomings in actual use: 1. The external buckle will cause the outer diameter of the probe insertion end to increase. Although the impact of the increase in the probe insertion end can be reduced by thinning the buckle thickness, the buckle thinning process is relatively difficult. In addition, the increase in the outer diameter of the probe will still limit its clinical use (such as smoothly passing through the puncture card); 2. Since the magnetic navigation sensor is external, there is still a risk of damage or even disconnection of the magnetic navigation sensor during use; 3. The external buckle and magnetic navigation sensor are consumables, and need to be disinfected and sterilized separately each time they are used clinically. In addition, the installation and disassembly of the external buckle are both difficult to operate, and even special disassembly tools are required, 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 puncture system, aiming to solve the problems of limited use, easy disconnection, high surgical cost and low efficiency after combining the intraoperative ultrasound probe with the magnetic navigation sensor in the related art.

[0008] Additional aspects and advantages of the present application will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the present application.

[0009] According to a first aspect of the present application, there is provided a magnetic navigation intraoperative ultrasound probe comprising an acoustic head, a bending portion, and a handle housing portion sequentially connected from a distal end to a proximal end of the probe, as well as a probe cable and a magnetic navigation sensor assembly;

[0010] The acoustic head is located at the farthest end of the probe, the acoustic head includes an acoustic emission window, and an installation slot for fixing the magnetic navigation sensor assembly is opened on the inner wall of the acoustic head;

[0011] The magnetic navigation sensor assembly includes a magnetic navigation sensor body and a sensor cable. The magnetic navigation sensor body is fixed to the mounting 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 inside the probe toward the proximal end of the probe.

[0012] In an exemplary embodiment of the present application, the magnetic navigation sensor assembly further includes a positioning member having a positioning groove formed thereon, the magnetic navigation sensor body being fixed in the positioning groove, and the positioning member being used to be fixedly connected to the mounting slot.

[0013] In an exemplary embodiment of the present application, the mounting slot is provided on the inner wall of the acoustic head directly below the center of the emission acoustic window.

[0014] 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 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 acoustic head, and the signal processor is connected between the magnetic navigation sensor body and the sensor cable.

[0015] In an exemplary embodiment of the present application, the probe cable includes an ultrasonic working cable and a reserved connecting cable, the sensor cable is located at 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 connecting cable, the ultrasonic working cable and the reserved connecting cable form an integrated wiring harness, and the probe cable extends from the distal end to the proximal end of the probe, through the curved portion, and toward the handle outer shell.

[0016] In an exemplary embodiment of the present application, the integrated wiring harness formed by the ultrasound working cable and the reserved connecting wire passes through the proximal end of the handle shell and is split into two bundles of cables again, wherein the reserved connecting cable is used to connect the navigation device, and the ultrasound working cable is used to connect the ultrasound device.

[0017] In an exemplary embodiment of the present application, the sensor cable and the probe cable are two independent wire harnesses, and both of the wire harnesses pass through the curved portion and extend toward the handle housing portion from the distal end to the proximal end;

[0018] The distal end of the sensor cable is fixed to the magnetic navigation sensor body, and the proximal end of the sensor cable is relatively fixed to the handle shell. A redundant section is provided in the middle section between the distal and proximal ends of the sensor cable. When the curved portion of the probe is bent, the redundant section can conform to the bending deformation of the curved portion and move forward and backward along the extension direction of the sensor cable to protect the sensor cable.

[0019] In an exemplary embodiment of the present application, it further includes a guide column with a smooth surface, which is fixed in the acoustic head or the handle shell along the length direction of the probe, and the redundant segment is movably wound around the guide column in a spiral manner.

[0020] In an exemplary embodiment of the present application, a hollow sensor wire harness protection tube is further included, 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 fixed relative to the magnetic navigation sensor body. The proximal end of the connecting tube section passes through the bending portion and is connected to the distal end of the spiral tube section located at the handle shell portion. The spiral tube section can be movably mounted on the wiring harness of the probe cable; the sensor cable is passed through the interior of the connecting tube section and the spiral tube section, and the redundant section extends in the spiral tube section in a spiral manner.

[0021] According to a second aspect of the present application, a puncture system is provided, comprising any one of the aforementioned magnetic navigation intraoperative ultrasound probes, a puncture kit, a navigation device, and an ultrasound device, wherein the puncture kit is provided with a second magnetic navigation sensor assembly, the sensor cable extending from the handle housing portion and connected to the navigation device, and the probe cable extending from the handle housing portion and connected to the ultrasound device;

[0022] The navigation device is configured to extract electromagnetic signals received by the magnetic navigation sensor assembly and the second magnetic navigation sensor assembly, and determine a positional relationship between the puncture kit and the intraoperative ultrasound probe based on the electromagnetic signals.

[0023] The exemplary embodiments of the present application may have some or all of the following beneficial effects:

[0024] 1. In the magnetic navigation intraoperative ultrasound probe provided in the exemplary embodiments of the present application, by inserting the magnetic navigation sensor assembly into the interior of the probe and securing the magnetic navigation sensor body of the magnetic navigation sensor assembly to a mounting slot within the acoustic head, the probe, after entering the human body, can determine the position of the intraoperative ultrasound probe based on the coordinate position of the magnetic navigation sensor body under the navigation device system, thereby facilitating puncture operations for medical personnel. Internally installing the magnetic navigation sensor body allows the magnetic navigation sensor body to effectively utilize the probe's internal space, thereby not increasing the outer diameter of the probe's insertion end and thus making the probe less susceptible to restrictions during clinical use. Furthermore, installing the magnetic navigation sensor within the probe protects the magnetic navigation sensor assembly through the acoustic head, curved portion, and handle housing, making it less susceptible to damage. Furthermore, installing the magnetic navigation sensor assembly within the probe eliminates the need for external mounting clips. Medical personnel only need to disinfect and sterilize the probe's exterior without disassembly, thereby reducing operational complexity for medical personnel and eliminating the need for specialized disassembly and assembly tools. This, in turn, reduces surgical costs and improves surgical efficiency.

[0025] 2. In the magnetic navigation intraoperative ultrasound probe provided in the exemplary embodiment of the present application, the mounting slot is positioned directly below the transmitting acoustic window, so that the magnetic navigation sensor body is located directly below the transmitting acoustic window, thereby improving the convenience of calibrating the position of the magnetic navigation sensor assembly and the positioning accuracy;

[0026] 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 impact of interference on the signal during transmission;

[0027] 4. In the magnetic navigation intraoperative ultrasound probe provided in the exemplary embodiments of the present application, the sensor cable is connected to a reserved connecting cable, allowing the magnetic navigation sensor body to transmit signals via the reserved connecting cable. The ultrasound working cable and the reserved connecting cable form an integrated wiring harness during the transmission process. This not only eliminates the need for separate wiring of the sensor cable, but also saves costs. Furthermore, the probe cable is thicker and more resistant to pulling. The sensor cable is transmitted to the proximal end of the probe via the probe cable, further reducing the risk of damage or even disconnection of the sensor cable when the curved portion bends.

[0028] 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 cable bundles, which can better isolate the signals and reduce mutual interference between the signals;

[0029] 6. In the magnetic navigation ultrasound probe provided in the exemplary embodiments 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. When the curved portion bends or straightens, the redundant section of the sensor cable can adaptively deform, making the sensor cable less susceptible to damage.

[0030] 7. In the magnetic navigation ultrasound probe provided in the exemplary embodiments of the present application, when the sensor cable and the probe cable are two independent cable bundles, the redundant sensor cable segment is wound around a smooth guide post. When the curved portion bends, the sensor cable can extend along the guide post. When the curved portion returns to its original state, the redundant sensor cable segment can also retract on its own. The guide post guides the extension and retraction of the redundant sensor cable segment, preventing the sensor cable segment from retracting and bending too little due to lack of guidance and causing damage.

[0031] 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 passed through 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.

[0032] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The accompanying drawings are incorporated into and constitute a part of the specification, illustrate embodiments consistent with the present application, and together with the specification, are used to explain the principles of the present application. Obviously, the drawings described below are only some embodiments of the present application, and those skilled in the art can derive other drawings based on these drawings without inventive effort.

[0034] Figure 1 A schematic structural diagram of an ultrasound probe used in magnetic navigation in Example 1 of the present application is shown;

[0035] Figure 2 A schematic diagram showing the structure of the bent portion before and after bending and the inserted tube layer in Example 1 of the present application is shown;

[0036] Figure 3 The figure shows a schematic structural diagram of the acoustic head in Example 1 of the present application;

[0037] Figure 4 The figure shows a schematic structural diagram of the integrated wiring harness in Example 1 of the present application;

[0038] Figure 5 A schematic diagram of a dual-cable structure with guide posts in Example 1 of the present application is shown;

[0039] Figure 6 A schematic diagram of a dual-cable structure with a sensor harness protection tube in Example 1 of the present application is shown.

[0040] Description of reference numerals:

[0041] 1. Acoustic head; 11. Emitting acoustic window; 111. Matching layer; 112. Piezoelectric crystal; 113. Backing; 2. Bending part; 3. Handle shell; 31. Insertion tube; 32. Handle end; 4. Magnetic navigation sensor assembly; 41. Magnetic navigation sensor body; 42. Sensor cable; 43. Positioning part; 44. Signal processor; 5. Probe cable; 51. Ultrasonic working cable; 52. Reserved connecting cable; 6. Guide column; 7. Sensor harness protection tube; 71. Connecting pipe section; 72. Spiral pipe section. DETAILED DESCRIPTION

[0042] Example embodiments will now be described more fully with reference to the accompanying drawings. However, the example embodiments can be implemented in many 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 concepts of the example embodiments to those skilled in the art. Like reference numerals in the figures represent like or similar structures, and thus their detailed descriptions will be omitted. Furthermore, the figures are merely schematic illustrations of the present application and are not necessarily drawn to scale.

[0043] While relative terms such as "upper" and "lower" are used in this specification to describe the relationship of one illustrated component to another, these terms are used for convenience only, such as in accordance with the orientation of the illustrations in the accompanying drawings. It should be understood that if the illustrated device were flipped upside down, the component described as "upper" would become the component "lower." When a structure is referred to as "on" another structure, this may mean that the structure is integrally formed with the other structure, that the structure is "directly" disposed on the other structure, or that the structure is "indirectly" disposed on the other structure through the other structure.

[0044] The terms "a", "an", "the" and "at least one" are used to indicate the presence of one or more elements / components / etc.; the terms "including" and "having" are used to express open-ended inclusion and mean that additional elements / components / etc. may be present in addition to the listed elements / components / etc.; the terms "first" and "second" are used only as labels and do not limit the quantity of their objects. Example 1

[0045] Reference Figure 1As shown, an embodiment of the present invention provides a magnetic navigation intraoperative ultrasound probe, comprising an acoustic head 1, a curved portion 2, and a handle housing 3 connected sequentially 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 3 further comprises an insertion tube 31 and a handle end 32. The acoustic head 1 is connected to the distal end of the curved portion 2 via a rigid connection, the distal end of the insertion tube 31 is connected to the proximal end of the curved portion 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 curved portion 2 is made of a serpentine tube, but this is not restrictive. The serpentine tube has good plasticity and can be restored to its original shape after bending deformation through control of its own structure and internal cues. During use, the operator can operate the handle of the handle end 32 to achieve the bending portion 2 driving the acoustic head 1 to bend forward, backward, left, or right.

[0046] Reference Figure 1 and Figure 2 As shown, further, the insertion tube 31 in the handle shell 3 is arranged from the outside to the inside in sequence as 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 single twisted wire tube 315, which can provide good protection for the signal transmission of the magnetic navigation sensor assembly 4 and reduce the interference of the external environment on the signal transmission.

[0047] Reference Figure 1-6 As shown, further, the acoustic head 1 is located at the farthest end of the probe, and the acoustic head 1 includes an emission acoustic window 11, which includes a matching layer 111, a piezoelectric crystal 112 and a backing 113 (as shown in FIG. Figure 3 ), a mounting slot for fixedly mounting the magnetic navigation sensor assembly 4 is provided on the inner wall of the ultrasonic 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 to the mounting slot so that the relative position of 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 toward the proximal end of the probe inside the probe. During use, the ultrasonic probe is used to transmit ultrasonic waves, which pass through the transmitting acoustic window 11. The magnetic navigation sensor body 41 is fixedly mounted through the mounting slot. On the one hand, this ensures that the magnetic navigation sensor assembly 4 maintains good stability; on the other hand, it maintains a constant relative position between the transmitting acoustic window 11 and the magnetic navigation sensor assembly 4, thereby ensuring the accuracy of signal acquisition. After the acquisition is completed, the signal will be transmitted through the sensor cable 42.

[0048] In the embodiment of the present application, the magnetic navigation sensor assembly 4 adopts a built-in design and is integrated into the probe. Compared with the solution of external magnetic navigation sensor, this design has the following significant advantages:

[0049] 1. Enhanced protection: The acoustic head 1, the curved portion 2, and the handle housing 3 together form a protective structure, effectively reducing the risk of damage to the magnetic navigation sensor assembly 4 during use;

[0050] 2. Improved anti-interference capability: The built-in layout significantly reduces external interference with 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;

[0051] 3. Compact structure and wider applicability: By optimizing the internal space utilization of the probe, this design does not increase the outer diameter of the probe insertion end while ensuring complete functionality. Therefore, the probe is less restricted in clinical use and expands the scope of clinical application.

[0052] 4. Excellent sealing and easy disinfection: Because the magnetic navigation sensor assembly 4 is completely integrated into the probe, eliminating the need for external clips, the probe offers excellent sealing, effectively preventing penetration of tissue fluid or blood. Postoperatively, routine disinfection of the probe surface is all that is required, eliminating the need for disassembly. This simplifies the disinfection process for medical staff, reduces surgical costs, and improves efficiency.

[0053] In the embodiment of the present application, the magnetic navigation sensor body 41 can be a coil, a magnetoresistive sensor (for example, a giant magnetoresistive sensor AMR, a tunnel magnetoresistive sensor TMR), or a combination of a sensor and a circuit. Of course, the above is only an exemplary description and is not restrictive.

[0054] In this embodiment of the present application, the magnetic navigation sensor assembly 4 also includes a positioning member 43 having a positioning slot defined therein. The magnetic navigation sensor body 41 is secured within the positioning slot, and the positioning member 43 is used to securely connect to the mounting slot. Specifically, during installation, the magnetic navigation sensor body 41 is first inserted into the positioning slot and secured to the positioning member 43. The positioning member 43 and the magnetic navigation sensor body 41 are then secured to the mounting slot. Subsequently, to further enhance the securement of the fixation, medical-grade epoxy resin adhesive may be used to reinforce the assembly, and laser welding or other reinforcement techniques may be employed to ensure that there is no risk of displacement during intraoperative probe bending (e.g., 180° rotation).

[0055] In the embodiment of the present application, to facilitate calibration of the positional relationship between the magnetic navigation sensor body 41 and the transmitting acoustic window 11, a mounting slot is provided on the inner wall of the acoustic head 1, directly below the center of the transmitting acoustic window 11. This structure ensures that the magnetic navigation sensor body 41 and the transmitting acoustic window 11 maintain a precise spatial correspondence; it also allows the operator to intuitively and quickly complete sensor positioning, avoiding the tedious and repeated calibration process required in the applicant's proposed technique of attaching a clip to the outside of the ultrasound probe during surgery, thereby eliminating positioning errors that may be caused by human intervention.

[0056] In an embodiment of the present application, the ultrasound probe in magnetic navigation also includes a signal processor 44. The signal processor 44 can be either a signal amplifier or a signal converter. When a signal amplifier is used, its function is to amplify the sensor signal collected by the magnetic navigation sensor body 41; when a signal converter is used, 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 transmits it to the navigation device.

[0057] Furthermore, a signal processor 44 is located within the acoustic head 1 and 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, direct transmission would be susceptible to interference due to the relatively long probe length, typically over 2 meters. Therefore, the signal processor 44 is placed between the magnetic navigation sensor body 41 and the sensor cable 42 because the magnetic navigation sensor body 41 can amplify and / or convert the signal after acquisition before transmitting it, further reducing interference during transmission.

[0058] In the present application, the magnetic navigation sensor body 41 and the signal processor 44 may be separate structures or integrated into one, and there is no limitation on this.

[0059] In one embodiment, the probe cable 5 includes an ultrasonic working cable 51 and a reserved connecting 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 connecting cable 52. The two can be connected by bundling, using a connector, or as an integrated structure, although this is not restrictive. The ultrasonic working cable 51 and the reserved connecting cable 52 form an integrated wiring harness. The probe cable 5 extends from the distal end to the proximal end of the probe, through the curved portion 2, and toward the handle housing 3. Specifically, when selecting the probe cable 5, the number of inner cores of the cable can be selected to be greater than the number of inner cores required by the ultrasonic probe. When in use, only 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 signal collected by the magnetic navigation sensor body 41 is transmitted through the probe cable 5. Since the probe cable 5 has strong tensile resistance and flexibility, the bending part 2 will not be damaged when bending.

[0060] Reference Figure 4 As shown, in this embodiment, the integrated wiring harness formed by the ultrasonic working cable 51 and the reserved connecting cable 52 is split into two bundles of cables again after passing through the proximal end of the handle shell portion 3, wherein the reserved connecting 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 connecting cable 52 after passing through the handle shell portion 3, it is convenient for the two to be connected to the navigation device and the ultrasonic device respectively, and mutual interference is avoided. In other embodiments, the integrated wiring harness formed by the ultrasonic working cable 51 and the reserved connecting cable 52 may no longer be split after passing through the proximal end of the handle shell portion 3, but the navigation and ultrasonic devices are directly connected through the integrated wiring harness. Therefore, when an integrated wiring harness is used, the navigation and ultrasonic devices can be an integrated structure.

[0061] Reference Figure 5 and Figure 6 As shown, in another embodiment, a dual-cable independent layout is employed, wherein the sensor cable 42 and the probe cable 5 are spatially independent of each other. Both cables are arranged along the probe axis, sequentially passing through the curved portion 2 from the distal end to the proximal end and extending to the handle housing 3. Specifically, the distal end of the sensor cable 42 is fixedly connected to the magnetic navigation sensor body 41, while the proximal end is fixed to the handle housing 3. A redundant section is provided in the middle section between the distal and proximal ends of the sensor cable 42. When the curved portion 2 of the probe bends, the redundant section can adapt to the bending deformation of the curved portion 2 and move forward and backward along the extension direction of the sensor cable 42 to protect the sensor cable 42.

[0062] 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 (thin wire diameter and poor tensile strength), so that when the bending part 2 is bent, the redundant section can dynamically adjust the cable margin to ensure that when the probe bends, the sensor cable 42 can be compensated for its length and stress concentration can be eliminated, thereby protecting the sensor cable 42 from damage and allowing the signal to be transmitted stably.

[0063] In this embodiment, to ensure the stability of the redundant segment during its forward and backward displacement, the present application provides two guiding schemes. The details are as follows:

[0064] Reference Figure 5 As shown, option one:

[0065] In this embodiment, the ultrasonic probe used in magnetic navigation also includes a smooth-surfaced guide post 6, which is arranged along the length of the probe. The guide post 6 can be fixed in the acoustic head 1 or in the handle housing 3. When arranged in the handle housing 3, it can be located in the insertion tube 31 or at the handle end 32. The redundant segment is movably mounted on the guide post 6 in a spiral winding manner. When the curved portion 2 bends, the redundant segment is stretched on the guide post 6 (manifested as an increase in pitch, a decrease in the inner diameter of the redundant segment, and an increase in the length of the redundant segment) to provide length compensation for the curved portion 2; when the curved portion 2 is straightened again, the redundant segment is restored accordingly.

[0066] It is understandable that the closer the guide post 6 is to the bend 2, the better the effect of length compensation of the bend 2 during use. Therefore, the optimal solution is to arrange the guide post 6 inside the acoustic head 1. The guide post 6 is located inside the acoustic head 1, closest to the bend 2, and has the fastest compensation response, which can achieve real-time and accurate length compensation. The second-best alternative (when there is insufficient space in the acoustic head 1) is to arrange it in the insertion tube 31 section, which still maintains good compensation timeliness and has a better compensation effect than the remote arrangement solution. The backup solution (when there is insufficient space inside the acoustic head 1, making the above solutions unfeasible) is to arrange it at the end of the handle (the space in the above two solutions is seriously insufficient), and there is a certain delay in the compensation response.

[0067] Reference Figure 6 As shown, option two:

[0068] In this embodiment, the magnetic navigation ultrasound probe further includes a hollow sensor harness protection tube 7, which is made of an 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 fixed relative to the magnetic navigation sensor body 41. The proximal end of the connecting tube section 71 passes through the bend 2 and is connected to the distal end of the spiral tube section 72 located on the handle housing 3. The spiral tube section 72 is movably mounted on a guide structure. The sensor cable is passed through the interior of the connecting tube section 71 and the spiral tube section 72, and the redundant section extends in a spiral manner within the spiral tube section 72. In this application, a guide column seat extending along the length of the probe and fixed relative to the handle housing 3 can be provided within the handle housing 3 as a guide structure. Alternatively, the wiring harness of the probe cable 5 can be directly used as a guide column, with the spiral tube section 72 wrapped around the probe cable 5.

[0069] This solution further shields the sensor cable 42 from external interference, preventing signal interference. The sensor harness protective tube 7 also protects the sensor cable 42, making it less susceptible to damage during stretching. In this solution, when the curved portion 2 bends, the spiral tube segment 72 and the internal sensor cable 42 are stretched along the length of the probe cable 5 (manifested by an increase in the pitch of the spiral tube segment 72, a decrease in the inner diameter, and an increase in the length of the spiral tube segment 72), thereby compensating for the length of the curved portion 2. When the curved portion 2 returns to its straightened state, the spiral tube segment 72 and the sensor cable 42 return to their original position.

[0070] In this embodiment, the connecting pipe section 71 is a straight pipe section and is arranged on one side of the probe cable 5. This structure prevents the bending portion 2 of the probe from being affected during movement, avoids interference with the bending portion 2 during bending, ensures that the bending portion 2 can maintain the maximum bending angle, and maintains the original flexibility and operability of the probe. Example 2

[0071] 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.

[0072] In terms of structural connections:

[0073] The puncture kit is provided with a second magnetic navigation sensor assembly 4 , the sensor cable 42 passes through the handle housing 3 and is connected to the navigation device, and the probe cable 5 passes through the handle housing 3 and is connected to the ultrasound device.

[0074] The system works as follows:

[0075] 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.

[0076] Those skilled in the art will readily appreciate other embodiments of the present invention after considering the specification and practicing the embodiments of the present invention. This application is intended to cover any variations, uses, or adaptations of the present invention that follow the general principles of the present invention and include common knowledge or customary techniques in the art that are not covered by this application. The specification and embodiments are intended to be exemplary only, and the true scope and spirit of the present invention are indicated by the appended claims.

Claims

1. A magnetic navigation intraoperative ultrasound probe, characterized in that: It includes an acoustic head, a bending part and a handle shell 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 end of the probe, the acoustic head includes an acoustic emission window, and an installation slot for fixing the magnetic navigation sensor assembly is opened 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 to the mounting slot so that the relative position of the magnetic navigation sensor body and the acoustic emission window remains unchanged. The sensor cable is connected to the proximal end of the magnetic navigation sensor body and extends inside the probe toward the proximal end of the probe. The magnetic navigation sensor assembly further includes a signal processor, which 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 transmit it 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; The probe cable includes an ultrasonic working cable and a reserved connecting 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 connecting cable. The ultrasonic working cable and the reserved connecting cable form an integrated wiring harness, which extends from the distal end to the proximal end of the probe, through the curved part, and toward the handle shell.

2. The magnetic navigation intraoperative ultrasound probe according to claim 1, characterized in that: The magnetic navigation sensor assembly further includes a positioning member, which is provided with a positioning groove. The magnetic navigation sensor body is fixed in the positioning groove. The positioning member is used to be fixedly connected to the installation slot.

3. The magnetic navigation intraoperative ultrasound probe according to claim 1, characterized in that: The installation slot is arranged on the inner wall of the acoustic head directly below the center of the emission acoustic window.

4. The magnetic navigation intraoperative ultrasound probe according to claim 1, characterized in that: The magnetic navigation sensor body and the signal processor are integrated into an integral structure.

5. The magnetic navigation intraoperative ultrasound probe according to claim 1, characterized in that: The integrated wiring harness formed by the ultrasound working cable and the reserved connecting cable passes through the proximal end of the handle housing and is split into two bundles of cables again, wherein the reserved connecting cable is used to connect to the navigation device, and the ultrasound working cable is used to connect to the ultrasound device; Alternatively, the integrated wiring harness formed by the ultrasound working cable and the reserved connection cable is no longer separated after passing through the proximal end of the handle shell part, and the integrated wiring harness is used to connect the navigation and ultrasound equipment.

6. A magnetic navigation intraoperative ultrasound probe, characterized in that: It includes an acoustic head, a bending part and a handle shell 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 end of the probe, the acoustic head includes an acoustic emission window, and an installation slot for fixing the magnetic navigation sensor assembly is opened 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 to the mounting slot so that the relative position of the magnetic navigation sensor body and the acoustic emission window remains unchanged. The sensor cable is connected to the proximal end of the magnetic navigation sensor body and extends inside the probe toward the proximal end of the probe. The magnetic navigation sensor assembly further includes a signal processor, which 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 transmit it 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; The sensor cable and the probe cable are two independent wire harnesses, and both of the wire harnesses extend from the distal end to the proximal end, through the curved portion, and toward the handle housing portion; The distal end of the sensor cable is fixed to the magnetic navigation sensor body, and the proximal end of the sensor cable is relatively fixed to the handle shell. A redundant section is provided in the middle section between the distal and proximal ends of the sensor cable. When the curved portion of the probe is bent, the redundant section can conform to the bending deformation of the curved portion and move forward and backward along the extension direction of the sensor cable to protect the sensor cable.

7. The magnetic navigation intraoperative ultrasound probe according to claim 6, characterized in that: It also includes a guide post with a smooth surface. The guide post is fixed in the acoustic head or the handle shell along the length direction of the probe, and the redundant section is movably wound around the guide post in a spiral manner.

8. The magnetic navigation intraoperative ultrasound probe according to claim 6, characterized in that: It also 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 fixed relative to the magnetic navigation sensor body. The proximal end of the connecting tube section passes through the bending portion and is connected to the distal end of the spiral tube section located on the handle shell portion. The spiral tube section can be movably mounted on a guide structure; the sensor cable is passed through the interior of the connecting tube section and the spiral tube section, and the redundant section extends in the spiral tube section in a spiral manner.

9. The magnetic navigation intraoperative ultrasound probe according to claim 8, characterized in that: The guide structure is a guide column extending along the length direction of the probe and fixedly arranged relative to the handle shell; or, the guide structure is a wire harness of the probe cable.

10. A puncture system, characterized in that: The invention comprises a magnetic navigation ultrasound probe, a puncture kit, a navigation device, and an ultrasound device according to any one of claims 1 to 9, wherein the puncture kit is provided with a second magnetic navigation sensor assembly, the sensor cable is connected to the navigation device after passing through the handle housing, and the probe cable is connected to the ultrasound device after passing through the handle housing; The navigation device is configured to extract electromagnetic signals received by the magnetic navigation sensor assembly and the second magnetic navigation sensor assembly, and determine a positional relationship between the puncture kit and the intraoperative ultrasound probe based on the electromagnetic signals.

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