Puncture positioning operation guiding device

Abstract

The invention provides a puncture positioning operation guiding device which comprises a base, a supporting rod and a guiding assembly which are sequentially connected, the base comprises a bottom plate and a guide rail outer cover which are fixedly connected, the supporting rod is formed by movably connecting at least one rotating pair, and the guiding assembly comprises a connecting part and an adjuster. A gradienter is arranged on the connecting part, the adjuster comprises an inclinometer and an angle indicating piece capable of rotating on the inclinometer, and a first positioning point is arranged at the end part of the inclinometer. According to the guiding assembly, the puncture precision is guaranteed, the operation convenience is improved, the guiding assembly can be used for guiding, assembling and disassembling the surgical needle at the same time, the frequency of repeatedly confirming the needle inserting point position and the needle inserting correctness in the operation is greatly reduced, and the pain of a patient is relieved.

Description

[0001] This application claims priority to the prior Chinese application, application number: 2023115197454, filing date November 15, 2023; all contents thereof are regarded as part of the present invention. Technical Field

[0002] The invention belongs to the field of medical devices, and specifically relates to a puncture positioning surgery guiding device. Background Art

[0003] In recent years, radiofrequency ablation (RFA) has been increasingly recognized by clinicians as a new, effective and minimally invasive treatment technology. Currently, radiofrequency ablation can be applied to a variety of solid tumors, including thyroid, lymphoma, liver cancer, lung cancer, kidney cancer, breast cancer and bone tumors. Remarkable results have been achieved in the treatment of primary and secondary liver tumors. Because of its minimally invasive, safe, repeatable, minimal damage to organ function and few complications, it has become an important means of comprehensive treatment of liver cancer and lung cancer.

[0004] Among them, lung nodules need to be preoperatively punctured and positioned before lung cancer surgery. However, the lack of a stable and reliable auxiliary stent greatly increases the difficulty of the doctor's surgery, making it impossible for the doctor to accurately insert the needle directly into the lesion. Multiple CT scans and multiple position adjustments are often required, which increases the risk of surgery and the patient's pain. Therefore, the fixation of ablation needles, coaxial needles and biopsy needles during surgery usually becomes a major problem that plagues surgeons. Currently, existing stents on the market are often accompanied by problems such as inability to reach a horizontal state or troublesome leveling, inconvenient operation, poor stability, inaccurate puncture, inability to remove the needle and inability to perform multi-needle ablation surgery. .

[0005] In other methods, in addition to ablation surgery that requires inserting the ablation needle into a specific designated location, there are also some methods that hope to insert microneedles into specific locations in the human body for sampling, or other surgeries or functions, such as inserting puncture needles into lesions for sampling, or when performing minimally invasive surgery, it is also necessary to allow these microneedles or puncture needles to enter the exact location of the human body to reduce unnecessary trauma.

[0006] This requires providing a device that can guide these puncture needles to be easy to operate, accurately enter the designated position of the body, and be more precise. Summary of the invention

[0007] The present invention provides a puncture positioning surgical guide device, which works together with a base, a support rod, and a guide component. The guide component ensures the accuracy of puncture and improves the ease of operation. It can simultaneously act on the guidance and loading and unloading of surgical needles, greatly reducing the number of times of repeated confirmation of the needle insertion point and the correctness of the needle insertion during the operation, thereby reducing the patient's pain.

[0008] In order to solve the above problems, the technical solution adopted by the present invention is as follows:

[0009] The present invention provides a device for guiding a puncture needle, characterized in that it includes an angle element with an angle scale and a guide element for guiding the puncture needle, wherein the guide element can rotate on the angle element, and the angle of the guide element can be adjusted by the rotation of the guide element, so that the puncture needle can enter the target point in the punctured subject according to the angle. The subject here can be a human or a mammal, and the target point here is a specific site of the human body, which can be a lesion, a nodule, a malignant nodule of a tumor, or any other place for the puncture needle to enter, such as a specific position in the spinal cord, etc.

[0010] In some embodiments, the guide element has a fulcrum on the angle element, and the guide element rotates around the fulcrum. The fulcrum is achieved by the rotation axis on the guide element cooperating with the hole on the angle element, so that the guide element can rotate around the fulcrum.

[0011] In some embodiments, the guide element has two ends, one end is used to indicate the angle, and the other end is used to guide the puncture needle. Indicating the angle is to align the angle scale on the angle element, and the other end is to guide the insertion path of the puncture needle. In some embodiments, the fulcrum is located between the two ends of the guide element.

[0012] In some embodiments, the guide element has an indicating needle at one end for indicating the angle, and a guide needle groove at the other end of the guide element, and the indicating needle is set to locate the angle scale on the angle element, so that the guide needle groove is positioned according to the angle. In some embodiments, the guide element includes an element with a pointer and an element with a guide needle groove, wherein the element with the guide needle groove can slide relative to the element with the pointer. This sliding is a sliding along the longitudinal direction of the guide element, so that the sliding of the guide needle groove can be adjusted, and the relative position of the target insertion position and the guide needle groove can be adjusted. In some embodiments, the element with the pointer and the element with the guide needle groove are assembled in a detachable manner relative to the angle element, or the element with the pointer and the element with the guide needle groove are assembled in a detachable manner. In this way, it is convenient to assemble when needed, and it is also convenient to replace the indicating needle element and the element with the groove.

[0013] In some embodiments, the angle element includes an annular edge and an angle surface connecting the annular edge, the annular edge has an angle scale, and the indicator needle is located on the annular edge for indicating the scale; or, the angle surface includes an angle scale, and the pointer is located in a window, and the angle scale of the pointer on the angle surface can be observed through the window. The window can also be located on the angle indicating element, so that the pointer on the edge of the angle element and the pointer in the window can be used together to locate the angle scale.

[0014] In some embodiments, the angle surface includes a slide groove, and the guide element includes a slide shaft that can slide in the slide groove. When the guide needle element needs to be fixed at the angle indicated by the indicator needle, the slide shaft can slide in the slide groove, and then the guide needle element is fixed on the angle indicating element through the slide shaft. Therefore, in some embodiments, the slide groove is also opened on the angle surface, and the slide groove and the angle scale are set accordingly. In this way, when the slide rail slides, the angle indicated by the angle indicating element causes the entire guide element to rotate together.

[0015] In some embodiments, one end of the sliding shaft is threadedly connected to the component with the pointer, and the other end has a nut. The nut allows the component with the pointer to be fixed on the angle surface, thereby fixing the component with the guide needle groove at a specified angle position.

[0016] In some embodiments, the device in any of the above embodiments includes a positioning element on the device, the positioning element and the upper surface of the needle guide element are in the same plane, or a certain point on the positioning element and the end point with the needle guide groove are in a straight line, or a certain point on the positioning element and the needle tip of the puncture needle in the needle guide groove are in a straight line, or the projection of the end face of the positioning element and the end point with the needle guide groove or the needle tip of the puncture needle are in the same straight line. In this way, the needle tip of the puncture needle can be punctured along the plane of the CT section without deviating from the plane.

[0017] In some embodiments, the positioning element is located at one end of the angle element, and the height of the positioning element is equal to the height of the element with the needle guide slot, or the height is equal to the height of the needle guide slot, or the height is equal to the angle surface of the position of the puncture needle relative to the angle element.

[0018] In some embodiments, the device includes two positioning elements, the two positioning elements are located at the two ends of the needle guide element, or the needle guide element is located between two positioning elements. In some embodiments, the end faces of the two positioning elements and the upper surface of the needle guide element are in the same plane, or a certain point on the two positioning elements and the end point with the needle guide groove are in a straight line, or a certain point on the two positioning elements and the needle tip of the puncture needle in the needle guide groove are in a straight line, or the projection of the end faces of the two positioning elements and the projection of the end point with the needle guide groove or the needle tip of the puncture needle are in the same straight line; or a certain point of the two positioning elements forms a straight line, and the upper surface of the element with the needle guide groove, the projection of the end point of the needle guide groove or the needle tip of the puncture needle are in the straight line.

[0019] In some embodiments, the device further comprises a level, which is used to adjust the angle between the angle element and the horizontal plane. In some embodiments, the angle is perpendicular to the horizontal plane or is 90 degrees to the horizontal plane.

[0020] A puncture positioning surgical guide device comprises a guide assembly, wherein the guide assembly comprises a connecting portion and an adjuster, wherein the adjuster comprises a guide element for guiding a puncture needle, wherein the angle element can rotate on an inclinometer. The angle element is provided with a first positioning point, wherein the first positioning point is fixed on the angle element, and the second positioning point is displaced as the angle element rotates. Further, a level is provided on the connecting portion. Further, an arc-shaped empty groove is provided on the angle element. Further, the guide device further comprises a slidably mounted base and a support rod, wherein the base comprises a fixedly connected bottom plate and a guide rail cover. Further, a guide rail is provided inside the guide rail cover, and a support rod is connected to the guide rail, and the support rod can rotate on the guide rail; the support rod is connected to the guide rail by bolts, and when the bolts are tightened, the support rod is fixed on the guide rail, and when the bolts are loosened, the support rod is fixed on the guide rail and rotates; preferably, the guide rail is a lockable guide rail, and an accordion protective cover is provided outside the guide rail. Further, the bottom plate is an arc bottom plate, and the curvature of the arc bottom plate fits the CT bed of the CT scanner. Further, the support rod is formed by at least one rotating pair movably connected, and preferably, the support rod is formed by four rotating pairs movably connected. Further, the end of the support rod is provided with a universal ball head, and the end of the connecting part is provided with a universal ball head sleeve matching the universal ball head.

[0021] The present invention has the following beneficial effects:

[0022] 1. Compared with conventional brackets on the market, the present invention sets a level at the front end of the inclinometer to ensure that the needle insertion position is horizontal after the inclinometer is fixed. Then the largest fault plane of the lesion is scanned by a CT machine and projected on the skin as a CT positioning line, so that the first positioning point in the inclinometer coincides with the CT positioning line and the second positioning point coincides with the puncture point on the CT laser line, thereby ensuring that the puncture is at the largest lesion and the accurate measurement of the puncture point. In addition, the guide buckle is provided with a plurality of puncture grooves of different specifications, which is convenient for the insertion of puncture needles, ablation needles, coaxial needles and biopsy needles of different specifications; the puncture channel of the present application is formed by a combination of a puncture through hole and a guide buckle, and the guide buckle can be disassembled from the puncture guide rail. The detachable structure is convenient for doctors to remove the needle, which is conducive to multi-needle ablation surgery and secondary needle insertion position adjustment.

[0023] 2. The base of the present invention has a simple overall structure, is easy to operate, and is a stable product. For multi-point and multi-lesions, it can solve surgical problems that are difficult to be solved by a single ablation needle through guide buckles of different specifications. It can guide and load and unload surgical needles, and can be used repeatedly in one operation to facilitate multi-needle ablation operations. The present application avoids the limitations of conventional auxiliary brackets, improves the accuracy and convenience of doctors' intraoperative operations, and greatly reduces the number of times the intraoperative CT scanner repeatedly confirms the needle insertion point and accuracy.

[0024] 3. The present invention is equipped with a lockable guide rail at the base to realize the lateral movement of the support rod so that it can be locked at the selected position. The support rod is connected to the base, and the support rod can be rotated and can also be adjusted up and down, front and back; the movable support rod can drive the guide assembly to move freely to the specified position on the plane perpendicular to the base plate and then be locked, and the universal ball head facilitates the adjuster to adjust the horizontality. An arc-shaped slot is provided on the inclinometer, and the center of the arc-shaped slot coincides with the center of the inclinometer. A knob is provided behind the scale needle to rotate the angle indicating needle along the arc-shaped slot to correspond to the required angle and fix it. The puncture guide rail can rotate with the scale needle, and can also move up and down relative to the scale needle, so that the second positioning point completely coincides with the puncture point. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 Schematic diagram of the combined structure with angled elements for guiding puncture.

[0026] Figure 2 Schematic diagram of the exploded structure with angle elements and guide elements.

[0027] Figure 3 It is a schematic diagram of the structure of the guiding element.

[0028] Figure 4 It is a schematic diagram of the structure of another angle of the guide puncture needle with angles of distance and proximity.

[0029] Figure 5A three-dimensional principle structure diagram for guiding the puncture needle for puncture.

[0030] Figure 6 It is a schematic diagram of the three-dimensional structure of the angle element for guiding puncture and the entire device.

[0031] Figure 7 The schematic diagram of the base plate structure.

[0032] Figure 8 This is the exploded diagram of the base plate;

[0033] Fig. 9 is a schematic diagram of the structure of the support rod;

[0034] Fig.10 It is a schematic diagram of the simulated structure of how the entire device is used for puncture.

[0035] Fig.11 For reference, the CT image is used as a schematic diagram of the simulated structure if the puncture needle enters the target at a certain angle. DETAILED DESCRIPTION

[0036] In order to describe the present invention more specifically, the technical solution of the present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. These descriptions are only to show how the present invention is implemented and cannot limit the specific scope of the present invention. The scope of the present invention is defined in the claims.

[0037] like Figures 1 to 6 As shown, the present invention provides a device for guiding a puncture needle, the device includes an angle disc 501, and a movable guiding element 400 is arranged on the angle disc. The cooperation between the guiding element and the angle disc can guide the angle of the puncture needle to penetrate, so that the angle of the puncture needle penetrating into the human body is more accurate without deviation. The activity here is mainly that the guiding element 400 can rotate on the angle disc. This rotation is mainly to allow the guiding element to rotate to a specific angle, and then allow the puncture needle to have a specific angle when inserted from the guiding element. Specifically, when a certain external puncture needle is used to enter a specific position of the human body, it is always hoped that the puncture needle can enter the center position of the lesion or a specified position. Usually, the position of the lesion is displayed through a CT photo, and then the position of the lesion relative to the CT photo is calculated, and then the position of the lesion is calculated. In theory, a general CT photo is perpendicular to the horizontal plane, and the puncture needle is also perpendicular to the horizontal plane for puncture, but this is not the case in reality. This is because although the CT images are perpendicular to the horizontal plane, each CT is only a section when it is viewed as a three-dimensional angle for the lesion. It has a horizontal plane, and also has up and down based on the horizontal plane. It also has another dimension, such as the X axis is horizontal, the Z axis is up and down, and the Y axis is another dimension. Only in this way can there be a three-dimensional spatial structure (such as Figure 5shown).

[0038] In order to make the puncture needle reach the specific location of the desired lesion, the needle needs to enter at an accurate three-dimensional angle. In addition to this factor, if the puncture needle is expected to enter the human body, the entry path is not blocked by bones or other organs are not damaged. This inevitably requires the selection of a specific location, and at the same time, it is expected that the location of the lesion is the shortest, bypassing the obstruction of bones or bypassing other organs. For example, there is a tumor tissue (or malignant nodule) (lesion) in the lung. As above, the lung is located on the chest. It is hoped that the puncture needle will reach the nodule to sample the nodule tissue, or release drugs through the puncture needle, or ablate the tumor. Therefore, in the above case, the puncture needle needs an angle, which enters the human body and can reach the specific lesion site, and the path is not blocked by bones or other organs. The lesion here generally refers to a site with a disease, such as a nodule or a diseased tissue. Of course, it can also refer to normal tissue. Any specific location where the needle enters the human body can be included in the meaning of the lesion, which is a specific implementation example of the lesion. The puncture needle here can be a needle for entering a lesion for surgery, a microneedle for taking samples, a needle for introducing drugs, and of course, a needle for tumor ablation. Any needle that penetrates a specific position in the human body is an implementation example of the present invention.

[0039] For example, Figure 5 As shown in the figure, it is a CT image. We hope that the tip of the puncture needle will reach the target position. The CT is perpendicular to the horizontal plane. In this way, we hope that the puncture needle will enter at an angle of 15 degrees with the direction deviation of the upper and lower Z axes, so that it can reach the center position. Figure 1 As shown, the corresponding angle of the guide element on the angle disc is at a position of 15 degrees. If the direction of rotation is also desired to be considered, the guide element has a fulcrum on the angle disc, which is generally fixed, for example Figure 2 The angle disk has a fixed fulcrum 504, and the guide element is fixed on the fulcrum. The guide element rotates around the fulcrum, and the direction of rotation is to rotate left and right along the angle disk, so as to reach the position with the angle scale on the angle disk. In some embodiments, the fulcrum position and the 0 degree position on the angle disk are substantially on the same straight line. The 0 degree position can be artificially a straight line perpendicular to the horizontal plane, combined with Fig.11 The specific rotation angle and direction can be determined. When the puncture needle is inserted from the specific position on the left side of the target, the guide element is rotated to the left on the angle disk, and one end of the guide element is aligned with an angle of 15 degrees. If the puncture needle is inserted from the position on the right side of the target, the guide element is rotated to the right on the angle disk, and one end of the guide element is aligned with an angle of 15 degrees.

[0040] In some embodiments, the guide element has two end points. One end point is used to align with the angle scale on the angle disk 501, and the other end point is where the puncture needle tip enters the body. Figure 3 As shown, the guide element 400 has an end point 4011, which is used to align with the angle scale on the angle disk to indicate the angle, and the other end point 4025 is where the needle tip of the puncture needle is inserted. Generally, the two end points 4011 and 4025 are on the same straight line, so that the angle at which the puncture needle enters the body is consistent with the indicated angle. Figure 1 As shown, the pointer of the guide element is aligned with 0 degrees at this time, and the end point 4025 is also at 0 degrees. In some embodiments, a guide groove 4024 is provided in the extension direction of the end point 4025, so that the puncture needle is set in the guide groove and then inserted into the human body through the groove 4024. In some embodiments, the center position of the longitudinal axis direction of the guide groove 4027 is on the same straight line as the two end points 4011 and 4025.

[0041] In some embodiments, the guide element and the angle disc are combined in a detachable manner. When necessary, the guide element and the angle disc can be combined together, and when the two need to be separated, they can be separated from the angle disc. This makes it convenient to install guide elements of different specifications on an angle disc. For example, when the thickness of the puncture needle is different, the size of the guide groove is also different, and the size of the appropriate guide groove needs to be replaced. In some embodiments, a fulcrum hole 504 is set on the angle disc, which is used as a fixed point for the rotation of the guide element, and a support shaft 4016 is set on the guide element, and the shaft passes through the fulcrum hole on the angle disc. For easy installation, a mounting hole 505 is opened on the angle disc, and the diameter of the mounting hole is larger than the diameter of the support shaft 4016, so that the nut 4017 of the support shaft passes through the mounting hole 405 and then slides into the fulcrum hole 504, and the diameter of the nut 4017 is larger than the diameter of the fulcrum hole 504, so that the shaft 4016 rotates in the fulcrum hole, but the position does not move. In some embodiments, a sliding track 503 is provided on the angle disk, and the sliding track is provided in the same manner as the angle indication scale, and a sliding shaft 301 is provided on the guide element, and the sliding shaft 301 has a nut 303, one end of the sliding shaft is fixed to the screw hole 4012 on the guide element by a thread, and the other end of the sliding shaft is fixed by a nut having a diameter greater than the width of the sliding rail, so that the guide element can slide in the sliding rail. Of course, the purpose of sliding is to make the guide element present a desired angle. The nut has two functions, one is for the convenience of installation (convenient for disassembly and installation), and the other is that after the angle is selected, the guide element is rotated to the specified angle, and the nut can be rotated to fix the guide element at the specified angle position without moving, and then the puncture needle is arranged in the guide groove to facilitate the puncture action.

[0042] In some embodiments, the guide element 400 includes an angle indicating element 401 and a guide needle element 402 for guiding the needle to penetrate. The guide needle element 402 can be longitudinally slidably matched with the angle indicating element 401. In some embodiments, the guide needle element 402 includes an end point 4025 for the puncture needle to penetrate and a guide needle groove 4024, and the angle indicating element includes an indicating needle 4018, which has an indicating head 4011 for indicating the angle scale on the angle disk.

[0043] In some embodiments, the angle disc has an angle scale, and the movable guide element can move according to the angle scale to a suitable angle. Figure 1 As shown, the guide element 400 is located at the position of 0 degrees, indicating that the guide element 400 is located at the position of 0 degrees, and the puncture needle is also inserted into the human body from the position of 0 degrees. At this time, 0 degrees can actually be understood as an angle perpendicular to the horizontal plane. The horizontal plane here is an assumed plane. 90-degree scales are set on the angle disk from 0 degrees to both sides. This setting can be an angle setting of every 1 degree, or every 2 degrees or 3 degrees, or the latter 10 degrees. This can be set according to different requirements. In short, the scale with angle indication set on the angle disk 501 indicates the angle relationship between the guide element 400 and the horizontal plane. For example, if the guide element 400 is expected to be 30 degrees with the horizontal plane, the guide needle element 402 can be rotated to the position of 30 degrees. Relative to the coordinate axis Y-Z axis, 30 degrees is respectively located at the position of the first quadrant 31 and the angle position of the fourth quadrant 30. If the guide element 400 is 30 degrees with the horizontal plane, the puncture needle guided by the guide element 400 is also inserted into the human body at an angle of 30 degrees. Of course, if the puncture needle inserted at the first quadrant 30 degrees or the fourth quadrant 30 enters the human body, the position may be at the same position, which is set for operational convenience.

[0044] In some embodiments, the guide element 400 can rotate on the angle disk, and this rotation is based on different angles. The purpose of the rotation is to align with the angle scale on the angle disk to find the required angle. More specifically, the guide element is provided with a guide needle groove 4024, and the guide needle groove 4024 allows the puncture needle to be inserted into the groove, and then inserted into the human body by relying on the guidance of the groove. Therefore, making the guide element 400 at different angles to the horizontal is essentially to make the center position of the guide needle groove 4024 form a desired angle with the horizontal plane. Therefore, a scale indicator head 4018 is provided on the guide element 400, and the tip 4011 of the scale indicator is on the same straight line as the horizontal center position of the guide needle groove 4024. In this way, the scale indicated by the tip indicates the angle between the guide needle groove 4024 and the horizontal plane.

[0045] like Figure 2As shown, the angle disc 500 has a disc body 502 and an edge 501 surrounding the disc body, the edge 501 is on the plane 502 surrounding the body, there are angle scales on the edge 501, and there are also angle scales on the main surface 502 near the outer surface, the scales on the edge 501 and the scales on the main plane are set correspondingly, and the edge has a height from the main plane. In some embodiments, the guide element 400 includes two components, one is an angle indicating element 401, and the other is an element 402 with a guide needle groove 4024, the element 402 with the guide needle groove 4024 can slide up and down on the angle indicating element 401, and the angle alignment element 401 rotates circumferentially on the angle disc to select a suitable angle. The angle indicating element 401 has a thickness 4013, and the angle indicating needle 4018 is located on the angle indicating element, so that the lower surface 4020 of the pointer 4018 is located on the edge 501, and can be close to the edge but does not affect the rotation of the pointer 4018. In this way, the angle indicating element 401 can be slid by hand, thereby driving the rotation of the pointer 4018, and then positioned at a specific angle, such as aligning with the angle scale on the edge 501. The guide needle element 402 is arranged on the angle indicating element 401 and slides through the slide groove. Therefore, a slide groove is arranged on the guide needle element 402, and the two edges 4021 and 4022 of the angle indicating element 401 are used as slide rails to allow the guide needle element 402 to slide on it. One function of the sliding movement is that when the puncture needle needs to be inserted through the guide needle element 402, the needle can be smoothly inserted into the guide needle groove 4023 and directly inserted into the human body. It is understood that the angle on the angle disc can have an angle scale on the edge or a scale on the body of the disc, and either one can achieve the positioning of the angle of the guide element. Figure 3 As shown, a window 4015 is provided on the angle indicating element 401, through which the angle scale on the main body 502 can be seen, and an angle indicating element 40 is provided on the window, and the element is used to set the angle. In a preferred embodiment, whether it is the angle indicating element 40 or the angle indicating needle 4018 located thereon, the center position thereof is kept in a straight line with the guide needle groove 4024, which is an optional solution.

[0046] In some embodiments, a cover sheet 700 is also provided on the needle guide element 402, which can slide on the needle guide element 402 and be assembled in a detachable manner. In this way, the cover sheet 700 and the needle guide groove 4024 are combined into a channel, which allows the puncture needle to pass through and guide the puncture needle through the needle guide groove 4024 to be inserted into the human body. In this way, the puncture needle is prevented from leaving the needle guide groove during puncture, and its direction is kept consistent. It can be understood that the puncture needle is generally manually given a puncture force to penetrate the human body. Due to individual differences in operation, such a needle guide groove or channel is used to allow the angle of the puncture needle to remain basically unchanged and enter the human body according to the set route.

[0047] The above methods are all based on a plane to adjust and indicate the angle, but in fact, the location of the lesion in the human body is a three-dimensional structure, such as Figure 5 As shown, the position of the lesion is a position in a three-dimensional structure, for example, YXZ represents different directions. Generally, CT photos are selected perpendicular to the horizontal plane, and the horizontal plane here generally refers to the plane formed by XY. In order to make the angle element or the guide element perpendicular to the horizontal plane, a water meter is also provided on the device to adjust the relationship between the angle element and the plane XY, generally to make the angle element perpendicular to the plane XY and to be in the same plane as the position of the photo taken by CT. Therefore, in some embodiments, the device also includes a level 200, which is used to adjust the angle between the angle element 500 and the horizontal plane XY. The purpose of adjusting the angle is to make the angle element and the surface taken by CT in the same plane, usually to make the angle element also perpendicular to the horizontal plane, such as the plane where XZ is located. The CT photo here is a photo obtained after the CT device scans the human body. In the CT photo, the lesion or the target point to be punctured is not in the center position and may be offset, so the angle of the guide element needs to be adjusted by the angle scale on the angle.

[0048] Even if the angle element is in the same plane as the surface photographed by CT, since the guiding element 400 itself has mechanical thickness, including the depth of the guide needle groove, the guide needle element with the guide needle groove also has mechanical thickness. In this way, although theoretically, the angle element can be in the same plane as the position photographed by CT, it is sometimes not accurate. After all, the use of horizontal instrument adjustment has errors and is not easy to operate. Theoretically, when the angle element is in the same plane as the surface photographed by CT, the position where the needle tip of the puncture needle is inserted is also in the same plane as the CT photographing surface. For the same three-dimensional tumor or lesion, CT can take multiple photos, and each CT photo is a section of the lesion. In order to allow the needle tip to accurately enter the position of the lesion, for example, to be inserted into the center of the lesion, in one method, a positioning element 900 is provided on the device, and the end 903 of the positioning element is in the same plane as the needle tip of the puncture needle, or the end is in the same plane as the upper surface of the guide needle element 402. In this way, when puncturing, the end 903 of the positioning element 900 is located at one end of the line where the CT image is located, and the projection of the surface of the guide needle element 402 is also located on the line where the CT image is located, thus ensuring that the puncture needle is inserted into the human body from the surface of the CT image. Figure 5 As shown, there is a theoretical CT photo 1, a section with a target position 2 on the CT photo, and the CT has a line 3, which is generally marked on the human skin and can be marked with a fluorescent line. The marked line indicates the plane where the position of a photo taken by the CT is located. During operation, the projection of the surface of the positioning end 903 is made to fall on the marked line 3, and the projection of the outer surface 4026 of the guide needle element 402 is also made to fall on the marked line 3, so that the projection of the top 4025 of the guide needle groove of the guide needle element can also be substantially located on the marked line 3. In this way, the needle tip of the puncture needle 5 can better enter the human body from the marked line 3.

[0049] In some embodiments, the positioning element 900 extends outward from the angle plate main body surface 502, extending outward perpendicularly to the surface 502. The height of the extension is substantially in the same horizontal plane as the outer surface 4026 with the guide needle groove. Alternatively, the height of the extension is in the same horizontal plane as the highest position of the puncture needle when the puncture needle is located in the guide needle groove 4024. In this way, in specific operations, there is generally a positioning line or marking line 3 on the human body, and the way to make the end 903 of the positioning element 900 and the surface 4026 of the guide needle element 402 in the same plane is to make the projection of the end face 903 of the positioning element 900 on the marking line 3, and the projection of the upper surface 4026 of the guide needle element on the marking line, and rely on the positioning line made in advance to determine the direction, so that it can be accurately inserted to the required designation. This is because, although the angle element 401 can set the angle of insertion of the guide element 400, and the horizontal instrument is to keep the guide needle element 402 and the entry path on the same plane. However, the needle guide element 402 has its own thickness, and the needle guide groove 4024 has different depths. The puncture needle 5 also has its own mechanical dimensions. How to make the puncture needle 5 enter the human body from the cross section of the CT photo without deviation requires the positioning element 900 to adjust so that the puncture needle 5 enters from the cross section of the CT photo. The positioning element 900 is used to avoid the angle element 401 from completely contacting the human skin. In actual operation, the human body surface is not horizontal, but has high and low positions. When the marking line is marked on the human body surface, it is also ups and downs. In this way, the end face 903 of the positioning element 900 and the surface of the needle guide element 402 or the end point 4025 of the needle guide groove coincide with the marking line, so that the puncture needle 5 can be well inserted into the human body from the plane of the CT photo represented by the marking line 3. In fact, a straight line is determined by two points, and the straight line coincides with the marking line or the marking line 3, so that the needle tip of the puncture needle 5 is inserted in the plane of the marking line 3, and the marking line 3 is a line scanned by a CT image, see Fig.10Of course, in some ways, two positioning elements 900 and 9002 can be set, located on both sides of the guide needle element 402, so that the guide needle element 402 is in the middle of the two positioning elements 900. The end faces 903 of the two positioning elements 900 or any other specified position can actually form a straight line with the end point 4025 of the guide needle slot. In this way, the two positioning elements 900 are actually used to specifically position the needle tip of the guide needle in a straight line with the two positioning elements. During the specific operation, as long as the projection of the end faces of the two positioning elements or the scales thereon are located on the marking line, it is natural that the projection of the end point 4025 of the guide needle slot 4024 can also be located on the marking line 3, so that the puncture needle can be inserted into the human body from the surface of the marking line. The so-called scale or any mark on the positioning element 900 can be used, and it is sufficient to make the marked point and the end point 4025 of the guide needle slot form a straight line.

[0050] like Figures 6 to 9 As shown, this embodiment provides a puncture positioning surgical guide device, including a base 101, a support rod 102 and a guide assembly 103 connected in sequence, the base includes a fixedly connected bottom plate 1011 and a guide rail cover 1012, the bottom plate is an arc bottom plate, the arc fits the arc of the CT machine tool on the CT scanner, and is convenient for placement and human body lying; a guide rail is arranged in the guide rail cover, and a support rod is connected to the guide rail through a support rod connecting piece 1014, the support rod is connected to the support rod connecting piece by a bolt and is arranged on the guide rail, the support rod can rotate on the guide rail, the support rod connecting piece fits the guide rail, and there is no tilt; the guide rail 1015 is a lockable guide rail, and an accordion protective cover 1013 is arranged outside the guide rail, the base can support the guide device as a whole, and the support rod can move with the sliding of the guide rail;

[0051] like Fig. 9 As shown, the support rod 102 is formed by at least one rotating pair 204 being movably connected. In this embodiment, four rotating pairs are provided. A connecting rod base 201 is provided at the bottom of the support rod. One end of the connecting rod base 201 is fixedly connected to the support rod connecting piece 1014, and the other end is connected to the connecting rod 202 pin to form a rotating pair. The rotating pair at the end of the support rod is provided with a universal ball head 203, and the end of the connecting part is provided with a universal ball head sleeve matching the universal ball head 203, and the two are connected by interference fit.

[0052] In actual application, the lesion is scanned by a CT scanner to find the largest fault plane of the lesion. The largest fault plane is projected on the skin surface as the CT positioning line 3, and the target point is confirmed on this section. Then, the puncture point is selected avoiding the ribs and blood vessels. The line connecting the puncture point and the target point is the body positioning line, that is, the puncture path of the puncture needle, and then the needle insertion angle (relative to the center of the earth) and the needle insertion depth are confirmed. The guiding device is adjusted according to the puncture point and the puncture angle for puncture. The body positioning line extends to the outside of the body as the CT laser line emitted by the CT scanner.

[0053] like Figure 5 , as shown in 10-11, if the puncture point on the surface of the patient's skin is assumed to be the origin and an XYZ three-dimensional coordinate system is established, then the plane on the surface of the patient's skin is the XY plane (or the bottom plate is the XY plane), and the Z axis is perpendicular to the surface of the patient's skin (or perpendicular to the bottom plate). The specific puncture operation steps are as follows:

[0054] (1) The patient lies on the base plate 1011, which is placed on the CT bed. The support rod 102 slides along the Y axis on the guide rail 1105. After sliding, the guide rail 1105 is locked to achieve a rough adjustment of the position of the support rod 102. This process adjusts the Y axis coordinates of the support rod 102 and the guide assembly 103 (i.e., adjusts the guide assembly to the maximum fault plane of the lesion);

[0055] (2) Rotate the support rod 102 to fine-tune the Y axis, then adjust each rotation pair 204 on the support rod 102, and then adjust the position of the guide assembly 103 on the XZ plane. This process adjusts the coordinates of the guide assembly 103 on the X axis and the Z axis (i.e., adjust the guide assembly to above the puncture point and adjust the first positioning point 900 to be located on the CT positioning line);

[0056] (3) Turn the universal ball head 203 and compare it with the level to ensure that the angle plate 500 is in a horizontal state and is perpendicular to the plane defined by the horizontal plane XZ axis;

[0057] (4) Turn the knob and rotate the scale needle to the target angle, such as 25 degrees, by comparing it with the CT image. Move the puncture guide rail 4024 up and down so that the second positioning point 4025 completely coincides with the puncture point. At this time, the end face of the first positioning point 900 and the projection of the second positioning point 9002 are both on the CT laser line. The first positioning point is located on the CT positioning line of the skin surface. At this time, select the guide buckle or cover sheet 700 according to the needle insertion specification. In this embodiment, the puncture needle 5 is selected, and the guide buckle of the puncture needle aperture is selected. The guide buckle is slidably mounted on the puncture guide rail 4024 through the guide buckle fixing groove. Then the puncture needle 5 is inserted along the puncture through hole until it reaches the target point.

[0058] In the above process, the top guide buckle 700 of the puncture hole for inserting the needle plays a fixing role to ensure the accuracy of needle insertion; if an ablation needle or biopsy needle is needed, the guide buckle can be removed and replaced with a guide buckle with a matching aperture with the target needle for multiple positioning and needle insertion.

[0059] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. A device for guiding a puncture needle, characterized in that: It comprises an angle element with an angle scale and a guiding element for guiding the puncture needle, wherein the guiding element can rotate on the angle element, and the angle of the guiding element is adjusted by the rotation of the guiding element, so that the puncture needle can enter the target point in the punctured body according to the angle.

2. The device for guiding a puncture needle according to claim 1, characterized in that: The guide element has a fulcrum on the angle indicating element, and the guide element performs a rotational movement around the fulcrum.

3. The device for guiding a puncture needle according to claim 2, characterized in that: The guiding element has two ends, one end of which is used to indicate an angle, and the other end of which is used to guide the puncture needle.

4. The device for guiding a puncture needle according to claim 3, characterized in that: The fulcrum is located between the two ends of the guiding element.

5. The device for guiding a puncture needle according to claim 4, characterized in that: The guiding element has an indicating needle at one end for indicating the angle, and a guiding needle slot at the other end of the guiding element. The indicating needle is configured to locate the angle scale on the angle element, so that the guiding needle slot is located according to the angle.

6. The device for guiding a puncture needle according to claim 5, characterized in that: The guiding element comprises an element with a pointer and an element with a guide needle groove, wherein the element with the guide needle groove can slide relative to the element with the pointer.

7. The device for guiding a puncture needle according to claim 6, characterized in that: The element with the pointer and the element with the needle guide groove are assembled in a detachable manner relative to the angle element, or the element with the pointer and the element with the needle guide groove are assembled in a detachable manner.

8. The device for guiding a puncture needle according to claim 7, characterized in that: The angle element includes an annular edge and an angle surface connecting the annular edge, the annular edge has an angle scale, and the indicator needle is located on the annular edge for indicating the scale; or, the angle surface includes an angle scale, and the pointer is located in a window, and the angle scale of the pointer on the angle surface can be observed through the window.

9. The device for guiding a puncture needle according to claim 8, characterized in that: The angle surface includes a slide groove, and the guiding element includes a slide shaft that can slide in the slide groove. When the guide needle element needs to be fixed at the angle indicated by the indicating needle, the slide shaft can slide in the slide groove, and then the guide needle element is fixed on the angle indicating element through the slide shaft.

10. The device for guiding a puncture needle according to claim 9, characterized in that: One end of the sliding shaft is threadedly connected to the component with the pointer, and the other end is provided with a nut, through which the component with the pointer is fixed on the angle surface, thereby fixing the component with the guide needle groove at a specified angle position.

11. The device for guiding a puncture needle according to any one of claims 1 to 10, characterized in that: The device includes a positioning element, which is in the same plane as the upper surface of the guide needle element, or a point on the positioning element is in a straight line with the end point with the guide needle groove, or a point on the positioning element is in a straight line with the needle tip of the puncture needle in the guide needle groove, or the projection of the end face of the positioning element and the projection of the end point with the guide needle groove or the needle tip of the puncture needle are in the same straight line.

12. The device for guiding a puncture needle according to claim 11, characterized in that: The positioning element is located at one end of the angle element, and the height of the positioning element is equal to the height of the element with the guide needle groove.

13. The device for guiding a puncture needle according to any one of claims 1 to 10, characterized in that: The device comprises two positioning elements, the two positioning elements are located at two ends of the needle guide element, or the needle guide element is located between two positioning elements.

14. The device for guiding a puncture needle according to claim 13, wherein the end faces of the two positioning elements and the upper surface of the needle guide element are in the same plane, or a certain point on the two positioning elements and the end point with the needle guide groove are in a straight line, or a certain point on the two positioning elements and the needle tip of the puncture needle in the needle guide groove are in a straight line, or the projection of the end faces of the two positioning elements and the end point with the needle guide groove or the projection of the needle tip of the puncture needle are in the same straight line; or a certain point of the two positioning elements forms a straight line, and the upper surface of the element with the needle guide groove, the end point of the needle guide groove or the projection of the needle tip of the puncture needle are in the straight line.

15. The device for guiding a puncture needle according to any one of claims 1 to 14, characterized in that: The device also includes a level, which is used to adjust the angle between the angle element and the horizontal plane.

16. The device for guiding a puncture needle according to claim 14, characterized in that: The angle is perpendicular to the horizontal plane or is 90 degrees to the horizontal plane.

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