Magnetic navigation intraoperative ultrasound probe and puncture system

Abstract

The application provides a magnetic navigation intraoperative ultrasound probe and puncture system, and relates to the technical field of medical equipment.The magnetic navigation intraoperative ultrasound probe comprises a sound head part and a magnetic navigation sensor assembly which are connected in sequence from the distal end to the proximal end of the probe.The sound head part is located at the farthest end of the probe, and the sound head part comprises a sound window.A mounting groove for fixing and mounting the magnetic navigation sensor assembly is arranged on the inner wall of the sound head part.The distal end of the magnetic navigation sensor assembly is fixed to the mounting groove so that the relative position of the magnetic navigation sensor assembly and the sound window is unchanged.The proximal end of the magnetic navigation sensor assembly extends to the proximal end of the probe in the interior of the probe.The problems of limited use, easy disconnection, high operation cost and low efficiency of the intraoperative ultrasound probe combined with the magnetic navigation sensor in the related art are solved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a magnetic navigation intraoperative ultrasound probe and puncture system. Background Technology

[0002] With the deep integration of ultrasound technology and laparoscopic technology, laparoscopic ultrasound (LUS) has emerged. Leveraging its high-resolution imaging advantage, LUS can accurately identify microsatellite lesions and metastases, clearly mark important ductal structures, accurately determine surgical margins, and guide puncture procedures in real time, effectively compensating for the visual blind spots in traditional laparoscopic liver surgery. Therefore, it is hailed by the surgical community as the "third eye."

[0003] Compared to open ultrasound-guided puncture techniques, laparoscopic ultrasound-guided puncture differs significantly. Specifically, laparoscopic ultrasound-guided puncture does not utilize a dedicated puncture frame and precise guide suture system, nor does it employ a specialized puncture needle. In clinical practice, surgeons typically use an 18G PTC needle, but this needle length is insufficient for punctures of certain liver segments. Furthermore, the puncture procedure is subject to numerous limitations: the surgeon must rely entirely on manual manipulation, and the puncture direction and needle insertion angle are strictly constrained.

[0004] To ensure clear visualization of the needle tip, when performing intrahepatic portal vein puncture under LUS guidance, a foot-to-cephalic approach is preferred. Key operational points include: accurately determining the puncture point on the liver surface based on the probe position, target vessel depth, and the angle between the needle and probe. During needle insertion, the probe position needs dynamic adjustment: first, retract the probe to clearly visualize the needle tip, then adjust the probe position in real time according to the insertion depth, monitoring the needle tip's trajectory throughout to avoid damage to important vessel structures. When the needle tip approaches the target hepatic segment of the portal vein, a slight axial rotation of the probe will simultaneously visualize the needle tip and the target hepatic pedicle, allowing for accurate assessment of their spatial relationship and determining whether the needle tip can safely enter the target hepatic segment of the portal vein.

[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 be moved towards the right foot or left head, respectively. The operator can dynamically adjust the needle insertion direction based on the changes in probe position and the relative position of the needle tip to the target portal vein. If the needle tip deviates significantly 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 can eventually be accurately penetrated.

[0006] Currently, in laparoscopic ultrasound-guided puncture surgery, in order to more accurately determine the position of the puncture kit, the applicant has proposed a technique for fixing a magnetic navigation sensor to an externally mounted ultrasonic probe during the operation. However, this technique still has some shortcomings in practical use: 1. The external mounting clip increases the outer diameter of the probe insertion end. Although the impact of the increased probe insertion end can be reduced by thinning the clip thickness, the clip thinning process is difficult. In addition, the increased outer diameter of the probe still limits its clinical use (e.g., smooth passage through the puncture card); 2. Because the magnetic navigation sensor is externally mounted, there is still a risk of damage or even wire breakage during use; 3. The external mounting clip and magnetic navigation sensor are consumables and require separate sterilization operations each time they are used clinically. Furthermore, the installation and removal of the external clip are difficult and even require specialized tools, 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, which aims to solve the problems of limited use, easy wire breakage, high surgical cost and low efficiency that exist in related technologies when combining intraoperative ultrasound probes with magnetic navigation sensors.

[0008] Additional aspects and advantages of this 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 this application.

[0009] According to a first aspect of this application, a magnetic navigation intraoperative ultrasound probe includes an acoustic head and a magnetic navigation sensor assembly.

[0010] The acoustic head includes an acoustic emission window, and the internal structure of the acoustic head has a mounting position.

[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 position so that the relative position of the magnetic navigation sensor body and the emission window remains unchanged. The sensor cable is connected to the proximal end of the magnetic navigation sensor body and extends into the proximal end of the probe inside the probe.

[0012] In one exemplary embodiment of this application, the magnetic navigation sensor assembly further includes a positioning member, which has a positioning groove. The magnetic navigation sensor body is fixed in the positioning groove, and the positioning member is fixedly connected to the mounting position.

[0013] In one exemplary embodiment of this application, the mounting position is configured as a mounting slot, which is located on the inner wall of the acoustic head directly below the center of the sound emission window.

[0014] In one exemplary embodiment of this application, the magnetic navigation sensor assembly further includes a signal processor, which is configured to amplify the sensor signal acquired by the magnetic navigation sensor body and / or convert the sensor signal acquired by the magnetic navigation sensor body into a digital signal and transmit it to the navigation device; the signal processor is located inside the acoustic head and is connected between the magnetic navigation sensor body and the sensor cable.

[0015] In one exemplary embodiment of this application, the magnetic navigation sensor body and the signal processor are integrated into a single structure.

[0016] In one exemplary embodiment of this application, a curved portion disposed near the proximal end of the acoustic window portion and a probe cable are also included. 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 integral cable bundle that extends from the distal end to the proximal end of the probe, passes through the curved portion, and extends toward the proximal end of the probe.

[0017] In one exemplary embodiment of this application, the integral cable bundle formed by the ultrasonic working cable and the reserved connecting cable passes through the proximal end of the probe and is then split into two cable bundles. The reserved connecting cable is used to connect to the navigation device, and the ultrasonic working cable is used to connect to the ultrasonic device.

[0018] Alternatively, the integrated cable bundle formed by the ultrasonic working cable and the reserved connecting cable passes through the proximal end of the probe and is not separated. The integrated cable bundle is used to connect the navigation and ultrasonic equipment.

[0019] In one exemplary embodiment of this application, the device further includes a curved portion disposed near the proximal end of the acoustic window portion, and a probe cable. The sensor cable and the probe cable are two independent wire bundles. Both wire bundles extend from the distal end to the proximal end through the curved portion toward the proximal end of the probe.

[0020] The distal end of the sensor cable is fixed to the magnetic navigation sensor body, and the proximal end of the sensor cable is fixed relative to the proximal end of the probe. A redundant section is provided in the middle section between the distal and proximal ends of the sensor cable. When the probe bends, the redundant section can adapt to the bending deformation of the bending part and move back and forth along the extension direction of the sensor cable to protect the sensor cable.

[0021] In one exemplary embodiment of this application, a handle housing portion is disposed near the proximal end of the curved portion, and a smooth guide post is provided. The guide post is fixed in the acoustic head or the handle housing portion along the length direction of the probe, and the redundant segment is movably wound around the guide post in a spiral manner.

[0022] In one exemplary embodiment of this application, a handle housing portion is disposed near the proximal end of the curved portion, and a hollow sensor harness protection tube is provided. The sensor harness protection tube is made of an elastic or soft material and includes a connecting tube segment and a spiral tube segment. The distal end of the connecting tube segment extends to the acoustic head and is fixed relative to the magnetic navigation sensor body. The proximal end of the connecting tube segment passes through the curved portion and connects to the distal end of the spiral tube segment located in the handle housing portion. The spiral tube segment is movably sleeved on a guide structure. The sensor cable passes through the interior of the connecting tube segment and the spiral tube segment, and the redundant segment extends spirally within the spiral tube segment.

[0023] In one exemplary embodiment of this application, the guide structure is a guide post extending along the length of the probe and fixedly disposed relative to the handle housing portion; or, the guide structure is a wire harness of the probe cable.

[0024] According to a second aspect of this application, a puncture system includes a magnetic navigation intraoperative ultrasound probe, a puncture kit, a navigation device, and an ultrasound device. The puncture kit is provided with a second magnetic navigation sensor assembly. The sensor cable passes through the proximal end of the probe and is connected to the navigation device. The probe cable passes through the proximal end of the probe and is connected to the ultrasound device.

[0025] The navigation device is configured 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.

[0026] The exemplary embodiments of this application may have some or all of the following beneficial effects:

[0027] 1. In the magnetic navigation intraoperative ultrasound probe provided in the example embodiment of this application, by inserting the magnetic navigation sensor assembly inside the probe and fixing the distal end of the magnetic navigation sensor assembly at the mounting position inside the ultrasound head, the probe can obtain the position of the intraoperative ultrasound probe based on the coordinate position of the magnetic navigation sensor assembly in the navigation device system after entering the human body, which facilitates the puncture operation for medical staff. Installing the magnetic navigation sensor assembly inside the probe allows for efficient use of the probe's internal space, thus not increasing the outer diameter of the probe insertion end, making the probe less restrictive in clinical use. Furthermore, installing the magnetic navigation sensor assembly inside the probe provides protection for the magnetic navigation sensor assembly, preventing damage. In addition, installing the magnetic navigation sensor assembly inside the probe eliminates the need for external clips; medical staff only need to disinfect the probe's exterior each time, without disassembly, thus reducing the operational difficulty for medical staff and eliminating the need for specialized disassembly and assembly tools, thereby reducing surgical costs and improving surgical efficiency.

[0028] 2. In the magnetic navigation intraoperative ultrasound probe provided in the example embodiment of this application, the mounting position is set as a mounting slot, and the mounting slot is opened directly below the sound emission window, so that the magnetic navigation sensor body is located directly below the sound emission window, which improves the convenience of calibrating the position of the magnetic navigation sensor component and the positioning accuracy.

[0029] 3. In the magnetic navigation intraoperative ultrasound probe provided in the example embodiment of this application, the sensor signal collected by the magnetic navigation sensor body is amplified and / or converted into a digital signal by a signal processor before being transmitted to the navigation device, so as to reduce the impact of interference on signal transmission;

[0030] 4. In the magnetic navigation ultrasound probe provided in the example embodiment of this 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. The ultrasound working cable and the reserved connection cable form an integrated cable bundle during transmission. On the one hand, this eliminates the need for separate wiring of the sensor cable, saving costs. On the other hand, the probe cable is thicker and has stronger tensile strength. The sensor cable uses the probe cable to transmit signals to the proximal end of the probe, which can further reduce the risk of sensor cable damage or even breakage when bending occurs at the bend.

[0031] 5. In the magnetic navigation intraoperative ultrasound probe provided in the example embodiment of this application, the sensor cable and the probe cable are two independent bundles of cables, which can achieve better isolation between signals and reduce mutual interference between signals;

[0032] 6. In the magnetic navigation ultrasound probe provided in the example embodiment of this application, when the sensor cable and the probe cable are two independent bundles of cables, the sensor cable is provided with a redundant section. When the bending part bends or straightens, the redundant section of the sensor cable can adapt to the deformation, making the sensor cable less prone to damage.

[0033] 7. In the ultrasonic probe for magnetic navigation provided in the example embodiment of this application, when the sensor cable and the probe cable are two independent wire bundles, the redundant section of the sensor cable is wound around a smooth guide post. When the bending part is bent, the sensor cable can extend along the guide post. When the bending part returns to its initial state, the redundant section of the sensor cable can also retract on its own. The guide post plays a guiding role in the extension and retraction of the redundant section of the sensor cable, so that the sensor cable is not prone to damage due to insufficient guidance and excessive bending.

[0034] 8. In the example embodiment of this application, in a magnetic navigation ultrasound probe, when the sensor cable and the probe cable are two independent cables, the sensor cable is run through the sensor harness protection tube. When the bend occurs, the spiral section of the sensor harness protection tube can pull the sensor cable along the length of the probe cable, thereby protecting the sensor cable through the sensor harness protection tube.

[0035] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0036] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. It is obvious that the drawings described below are merely some embodiments of this application, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort.

[0037] Figure 1 A schematic diagram of the structure of an ultrasonic probe used in magnetic navigation surgery according to Embodiment 1 of this application is shown;

[0038] Figure 2 This paper shows a schematic diagram of the structure of the bent section before and after bending and the inserted tube layer in Embodiment 1 of this application;

[0039] Figure 3 A schematic diagram of the acoustic head structure in Embodiment 1 of this application is shown;

[0040] Figure 4 A schematic diagram of the integrated wire harness in Embodiment 1 of this application is shown;

[0041] Figure 5 A schematic diagram of a dual-cable structure with guide posts in Embodiment 1 of this application is shown;

[0042] Figure 6 A schematic diagram of a dual-cable structure with a sensor harness protection tube is shown in Embodiment 1 of this application.

[0043] Explanation of reference numerals in the attached figures:

[0044] 1. Acoustic head; 11. Acoustic emission window; 111. Matching layer; 112. Piezoelectric crystal; 113. Backing; 2. Bending section; 3. Handle housing; 31. Insertion tube; 32. Handle end; 4. Magnetic navigation sensor assembly; 41. Magnetic navigation sensor body; 42. Sensor cable; 43. Positioning component; 44. Signal processor; 5. Probe cable; 51. Ultrasonic working cable; 52. Reserved connection cable; 6. Guide post; 7. Sensor harness protection tube; 71. Connecting tube section; 72. Spiral tube section. Detailed Implementation

[0045] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary 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 concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore their detailed descriptions will be omitted. Furthermore, the drawings are merely illustrative of this application and are not necessarily drawn to scale.

[0046] 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, these terms are used only for convenience, such as according to the orientation of the examples in the accompanying drawings. It is understood that if the device of the icon is flipped so that it is upside down, the component described as "upper" will become the component described as "lower." When a structure is "upper" of another structure, it may mean that the structure is integrally formed on the other structure, or that the structure is "directly" mounted on the other structure, or that the structure is "indirectly" mounted on the other structure through another structure.

[0047] The terms “a,” “one,” “the,” and “at least one” are used to indicate the existence of one or more elements / components / etc.; the terms “including” and “having” are used to indicate an open-ended inclusion and to mean that there may be other elements / components / etc. in addition to the listed elements / components / etc.; the terms “first” and “second” are used only as markers and are not a limitation on the number of objects.

[0048] Example 1

[0049] Reference Figure 1 As shown, this embodiment of the invention provides a magnetic navigation ultrasound probe, including an acoustic head 1, a bending portion 2, and a handle housing 3 connected sequentially from the distal 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 includes an insertion tube 31 and a handle end 32. The acoustic head 1 is connected to the distal end of the bending portion 2 via a rigid connection, and the distal end of the insertion tube 31 is connected to the proximal end of the bending portion 2. The handle end 32 is located at the proximal end of the insertion tube 31. In this embodiment, the bending portion 2 is made of a snake-bone tube, but this is not a limitation. Snake-bone tubes have good plasticity and can recover to their initial shape after bending deformation through their own structure and internal cues. In use, the surgeon can bend the acoustic head 1 forward, backward, left, and right by operating the handle end 32.

[0050] Reference Figure 1 and Figure 2 As shown, the insertion tube 31 in the handle housing 3 is further configured from the outside to the inside 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 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.

[0051] 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 acoustic emission window 11, which includes a matching layer 111, a piezoelectric crystal 112, and a backing 113 (e.g., ...). Figure 3 The acoustic head 1 has an internal structure with a mounting position for fixing the magnetic navigation sensor assembly 4. The magnetic navigation sensor assembly 4 includes a magnetic navigation sensor body 41 and a sensor cable 42. In this application, the specific location of the mounting position within the acoustic window 1 is not specifically limited. The specific function of the mounting position is to fix the magnetic navigation sensor body 41 there, so that the relative position of the magnetic navigation sensor body 41 and the emitting 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, which pass through the emitting acoustic window 11. The magnetic navigation sensor body 41 is fixedly installed through the mounting position. 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 emitting acoustic window 11 and the magnetic navigation sensor body 41, thereby ensuring the accuracy of signal acquisition. After the acquisition is completed, the signal is transmitted through the sensor cable 42.

[0052] In this embodiment, the magnetic navigation sensor assembly 4 is designed to be built-in and integrated inside the probe. Compared to an externally mounted magnetic navigation sensor, this design has the following significant advantages:

[0053] 1. Enhanced protection: The sound head 1, the bending part 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;

[0054] 2. Enhanced anti-interference capability: The built-in layout can significantly 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;

[0055] 3. Compact structure and wider applicability: By optimizing the utilization of the internal space of the probe, this design ensures complete functionality without increasing the outer diameter of the probe insertion end. Therefore, the probe is less restricted in clinical use and its clinical application range is broadened.

[0056] 4. Excellent sealing and easy sterilization: Since the magnetic navigation sensor component 4 is completely built into the probe, eliminating the need for external clips, the probe boasts excellent sealing, effectively preventing the penetration of human tissue fluid or blood. Postoperatively, only routine disinfection of the probe surface is required; disassembly is unnecessary, simplifying the sterilization process for medical staff, reducing surgical costs, and improving surgical efficiency.

[0057] In the embodiments of this application, the magnetic navigation sensor body 41 can be a coil, a magnetoresistive sensor (e.g., giant magnetoresistive sensor AMR, tunnel magnetoresistive sensor TMR), or a combination of sensor and circuit. Of course, the above is only an exemplary description and is not restrictive.

[0058] In this embodiment, the magnetic navigation sensor assembly 4 further includes a positioning member 43. The positioning member 43 has a positioning groove, and the magnetic navigation sensor body 41 is fixed within the positioning groove. The positioning member 43 is used for fixed connection to the mounting position. Specifically, during installation, the magnetic navigation sensor body 41 is first inserted into the positioning groove and fixed to the positioning member 43, and then the positioning member 43 and the magnetic navigation sensor body 41 are fixed at the mounting position. Subsequently, to enhance its fixation firmness, it can be reinforced with medical-grade epoxy resin adhesive and further reinforced by laser welding or other processes to ensure no displacement risk when the probe is bent during surgery (e.g., rotated 180°).

[0059] In a preferred embodiment of this application, to facilitate the calibration of the positional relationship between the magnetic navigation sensor body 41 and the transmitting acoustic window 11, the mounting position is set as a mounting slot, which is located on the inner wall of the acoustic head 1 directly below the center of the transmitting acoustic window 11. This structure ensures a precise spatial correspondence between the magnetic navigation sensor body 41 and the transmitting acoustic window 11; at the same time, the operator can intuitively and quickly complete the sensor positioning, avoiding the cumbersome and repeated calibration process in the technique proposed by the applicant of fixing the magnetic navigation sensor with a snap-fit ​​on the outside of the intraoperative ultrasound probe; thus eliminating positioning errors that may be caused by human operation.

[0060] In this embodiment of the application, the ultrasonic probe in magnetic navigation surgery also includes a signal processor 44. The signal processor 44 can be 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.

[0061] Furthermore, the signal processor 44 is located inside the acoustic head 1 and 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, direct transmission would be susceptible to interference due to the relatively long probe, typically over 2 meters. Therefore, the signal processor 44 is placed between the magnetic navigation sensor body 41 and the sensor cable 42 so that the magnetic navigation sensor body 41 can amplify and / or convert the signal after acquisition before transmission, thereby further reducing interference during transmission.

[0062] In this application, the magnetic navigation sensor body 41 and the signal processor 44 can be either separate structures or integrated into one unit, and there is no limitation on this.

[0063] 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 inside 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 connection between the two can be achieved by bundling, using a connector, or as an integrated structure; however, this is not a limitation. The ultrasonic working cable 51 and the reserved connecting cable 52 form an integrated cable harness. The probe cable 5 extends from the distal end to the proximal end of the probe, passes through the bend 2, and extends towards the handle housing 3. Specifically, when selecting the probe cable 5, the number of inner cores can be greater than the number of inner cores required for the ultrasonic probe. During use, only a portion of the cable is used for ultrasonic transmission (this portion of the cable is regarded as the ultrasonic working cable 51), while 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 strength and flexibility, the bending part 2 will not be damaged when it is bent.

[0064] Reference Figure 4 As shown, in this embodiment, the integrated cable bundle formed by the ultrasonic working cable 51 and the reserved connecting cable 52 exits from the proximal end of the handle housing 3 and is then split into two cables. The reserved connecting cable 52 is used to connect to the navigation device, and the ultrasonic working cable 51 is used to connect to the ultrasonic device. By splitting the ultrasonic working cable 51 and the reserved connecting cable 52 after they exit the handle housing 3, it is convenient to connect the navigation device and the ultrasonic device respectively, and mutual interference is avoided. In other embodiments, the integrated cable bundle formed by the ultrasonic working cable 51 and the reserved connecting cable 52 may not be split after exiting from the proximal end of the handle housing 3, and the navigation and ultrasonic devices may be directly connected through the integrated cable bundle. Therefore, when an integrated cable bundle is used, the navigation and ultrasonic devices can be a single structure.

[0065] Reference 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. Both cables are arranged along the probe axis, passing through the bend 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, and 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 probe bend 2 is bent, the redundant section can adapt to the bending deformation of the bend 2 and move back and forth along the extension direction of the sensor cable 42 to protect the sensor cable 42.

[0066] The sensor cable 42 and the probe cable 5 are transmitted independently, which can further reduce mutual signal interference. In view of the characteristics of the sensor cable 42 (thin wire diameter and poor tensile strength), a redundant section is added. When the bending part 2 is bent, the redundant section can dynamically adjust the cable margin to ensure that the length of the sensor cable 42 can be compensated and stress concentration can be eliminated when the probe is bent. This protects the sensor cable 42 from damage and ensures stable signal transmission.

[0067] In this embodiment, to ensure the motion stability of the redundant segment during the forward and backward displacement processes, this application provides two guiding schemes. The details are as follows:

[0068] Reference Figure 5 As shown, Option 1:

[0069] In this scheme, the ultrasonic probe in magnetic navigation also includes a smooth guide post 6. The guide post 6 is arranged along the length of the probe and can be fixed inside the acoustic head 1 or inside the handle housing 3. When it is set in the handle housing 3, it can be located inside the insertion tube 31 or at the handle end 32. The redundant section is movably sleeved on the guide post 6 in a spiral winding manner. When the bending part 2 bends, the redundant section is elongated on the guide post 6 (manifested as an increase in 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 straightens, the redundant section also straightens.

[0070] Understandably, the closer the guide post 6 is to the bend 2, the better the length compensation effect of the bend 2 during use. Therefore, placing the guide post 6 inside the acoustic head 1 is the optimal solution. With the guide post 6 inside the acoustic head 1, closest to the bend 2, the compensation response is the fastest, achieving real-time and accurate length compensation. A second-best alternative (when space in the acoustic head 1 is insufficient) is to place it in the insertion tube 31 section, still maintaining good compensation timeliness and offering better compensation than the far-end placement option. A backup option (when internal space in the acoustic head 1 is insufficient, making the aforementioned options infeasible) is to place it at the end of the handle (where space is severely limited in the aforementioned two options), but the compensation response has a certain delay.

[0071] Reference Figure 6 As shown, Option 2:

[0072] In this scheme, the ultrasonic probe in magnetic navigation also includes a hollow sensor harness protection tube 7. The sensor harness protection tube 7 is made of elastic or soft material and 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 connects to the distal end of the spiral tube section 72 located in the handle housing 3. The spiral tube section 72 is movably fitted onto a guide structure. The sensor cable passes through the interior of the connecting tube section 71 and the spiral tube section 72, and the redundant section extends spirally within the spiral tube section 72. In this application, a guide post seat extending along the probe length direction and fixed relative to the handle housing 3 can be provided in the handle housing 3 as a guide structure; alternatively, the probe cable 5 harness can be directly used as a guide post, so that the spiral tube section 72 is wound around the probe cable 5.

[0073] This design further shields the sensor cable 42 from external interference, preventing signal interference. Simultaneously, the sensor harness protection tube 7 protects the sensor cable 42, preventing damage during stretching. In this design, when the bend 2 bends, the spiral tube segment 72 and the internal sensor cable 42 are stretched together along the length of the probe cable 5 (resulting in an increased pitch, decreased inner diameter, and increased length of the spiral tube segment 72), thus compensating for the length of the bend 2. When the bend 2 returns to its straight state, the spiral tube segment 72 and the sensor cable 42 return to their original position.

[0074] In this design, the connecting pipe section 71 is a straight pipe section, which is located on one side of the probe cable 5. This structure ensures that the bent part 2 of the probe is not affected during movement, avoids interference with the bent part 2 during bending, and ensures that the bent part 2 can maintain the maximum bending angle, thus maintaining the original flexibility and operability of the probe.

[0075] Example 2

[0076] This invention provides a puncture system, which includes any of the magnetic navigation ultrasound probes in Embodiment 1, as well as a puncture kit, a navigation device, and an ultrasound device.

[0077] Regarding structural connections:

[0078] The puncture kit is equipped 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. The probe cable 5 passes through the handle housing 3 and is connected to the ultrasound device.

[0079] The working principle of this system is as follows:

[0080] 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.

[0081] Other embodiments of this application will readily conceive of by those skilled in the art upon consideration of the specification and practice of the embodiments thereof. This application is intended to cover any variations, uses, or adaptations of this application that follow the general principles of this application and include common knowledge or customary techniques in the art not claimed in this application. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of this application are indicated by the appended claims.

Claims

1. A magnetic navigation intraoperative ultrasound probe, characterized in that, Including acoustic head and magnetic navigation sensor components; The acoustic head includes an acoustic emission window, and the internal structure of the acoustic head has a mounting position. 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 position so that the relative position of the magnetic navigation sensor body and the emission window remains unchanged. The sensor cable is connected to the proximal end of the magnetic navigation sensor body and extends into the proximal end of the probe inside the probe.

2. The magnetic navigation intraoperative ultrasound probe according to claim 1, characterized in that, The magnetic navigation sensor assembly also includes a positioning component, which has a positioning groove. The magnetic navigation sensor body is fixed in the positioning groove, and the positioning component is fixedly connected to the mounting position.

3. The magnetic navigation intraoperative ultrasound probe according to claim 2, characterized in that, The mounting position is set as a mounting slot, which is located on the inner wall of the acoustic head directly below the center of the sound emission window.

4. The magnetic navigation intraoperative ultrasound probe according to claim 1, characterized in that, The magnetic navigation sensor assembly further includes a signal processor, which is configured to amplify the sensor signal acquired by the magnetic navigation sensor body and / or convert the sensor signal acquired by the magnetic navigation sensor body into a digital signal and transmit it to the navigation device; the signal processor is located inside the acoustic head and is connected between the magnetic navigation sensor body and the sensor cable.

5. The magnetic navigation intraoperative ultrasound probe according to claim 4, characterized in that, The magnetic navigation sensor body and the signal processor are integrated into a single structure.

6. The magnetic navigation intraoperative ultrasound probe according to claim 4 or 5, characterized in that, It also includes a curved section connected to the proximal end of the acoustic window, and a probe cable. 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 integral cable bundle, which extends from the distal end to the proximal end of the probe, through the curved section, and toward the proximal end of the probe.

7. The magnetic navigation intraoperative ultrasound probe according to claim 6, characterized in that, The integrated cable bundle formed by the ultrasonic working cable and the reserved connecting cable exits from the proximal end of the probe and is then split into two cable bundles. The reserved connecting cable is used to connect to the navigation device, and the ultrasonic working cable is used to connect to the ultrasonic device. Alternatively, the integrated cable bundle formed by the ultrasonic working cable and the reserved connecting cable passes through the proximal end of the probe and is not separated. The integrated cable bundle is used to connect the navigation and ultrasonic equipment.

8. The magnetic navigation intraoperative ultrasound probe according to claim 4 or 5, characterized in that, It also includes a bend connected to the proximal end of the acoustic window and a probe cable. The sensor cable and the probe cable are two separate cable bundles. Both cable bundles extend from the distal end to the proximal end through the bend and toward the proximal end of the probe. The distal end of the sensor cable is fixed to the magnetic navigation sensor body, and the proximal end of the sensor cable is fixed relative to the proximal end of the probe. A redundant section is provided in the middle section between the distal and proximal ends of the sensor cable. When the probe bends, the redundant section can adapt to the bending deformation of the bending part and move back and forth along the extension direction of the sensor cable to protect the sensor cable.

9. The magnetic navigation intraoperative ultrasound probe according to claim 8, characterized in that, It also includes a handle housing portion connected to the proximal end of the curved portion, and a smooth guide post, the guide post being fixed in the acoustic head or the handle housing portion along the length direction of the probe, the redundant segment being movably wound around the guide post in a spiral manner.

10. The magnetic navigation intraoperative ultrasound probe according to claim 8, characterized in that, It also includes a handle housing connected to the proximal end of the bend, and a hollow sensor harness protection tube. The sensor harness protection tube is made of an elastic or soft material and includes a connecting tube segment and a spiral tube segment. The distal end of the connecting tube segment extends to the acoustic head and is fixed relative to the magnetic navigation sensor body. The proximal end of the connecting tube segment passes through the bend and connects to the distal end of the spiral tube segment located on the handle housing. The spiral tube segment is movably fitted onto a guide structure. The sensor cable passes through the interior of the connecting tube segment and the spiral tube segment, and the redundant segment extends spirally within the spiral tube segment.

11. The magnetic navigation intraoperative ultrasound probe according to claim 10, characterized in that, The guide structure is a guide post that extends along the length of the probe and is fixedly disposed relative to the outer casing of the handle; or, the guide structure is the wire harness of the probe cable.

12. A puncture system, characterized in that, The device includes a magnetic navigation intraoperative ultrasound probe, a puncture kit, a navigation device, and an ultrasound device as described in any one of claims 1-11. The puncture kit is provided with a second magnetic navigation sensor assembly, the sensor cable passes through the proximal end of the probe and is connected to the navigation device, and the probe cable passes through the proximal end of the probe and is connected to the ultrasound device. The navigation device is configured 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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