Puncture guide and method for manufacturing same, and puncture guide manufacturing device

Abstract

To provide a puncture guide (1) for accurately and easily puncturing an affected part upon adjusting the depth and angle of a needle with which puncturing is to be performed. Provided is a puncture guide comprising: a connector (20) that guides a base part provided with a needle and that has a recess (21) for adjusting the depth of puncturing by the needle; and a main body (10) that is shaped so as to conform to the outer shape of a part of the body. The part of the body is the chest. The inside of the recess is provided with a step or a projection, and the depth of the puncturing by the needle mounted on the base part is adjusted by means of the projection or the step. The base part is a syringe (30), and injects a dye into a part of the body. The puncture guide may be such that the connector and the main body are integrated.

Description

Puncture guide and its manufacturing method, and puncture guide manufacturing device

[0001] The present disclosure relates to a puncture guide, a method for manufacturing the same, and an apparatus for manufacturing the puncture guide.

[0002] Diseases and abnormalities can occur in human soft tissues. Accurately examining and diagnosing these lesions (affected areas) and appropriately treating them requires direct access to the affected area. This examination, diagnosis, and treatment can involve administering drugs, collecting samples, and irradiating electromagnetic waves. Magnetic resonance imaging (MRI) images and computed tomography (CT) images are valuable sources of information because they can accurately identify the location, size, and shape of the affected area. Approaching the affected area requires minimally invasive techniques, such as the use of a puncture needle. However, because the shape of soft tissue changes depending on posture and position, accurate access to the affected area can be difficult, and improved techniques are needed.

[0003] In breast-conserving surgery for breast cancer patients, the affected area and a 1-1.5 cm area surrounding the affected area are removed. Therefore, in breast-conserving surgery, the area to be resected is defined by preoperative marking. However, the human breast, especially the female breast, contains soft tissue such as fat, which deforms when force is applied, making accurate marking difficult.

[0004] Patent Literature 1 describes a suction molding cup that can image the position of a tumor in soft tissue and reproduce that position during treatment, thereby concentrating radiation therapy on the tumor. During imaging and treatment, the suction molding cup suctions the patient's soft tissue, fixing the soft tissue along the inner surface of the suction molding cup, thereby reproducing the tumor's position at the time of imaging. This makes it easy to identify the tumor's location, even in soft tissue that moves, such as the tip of the tongue, and allows for focused radiation irradiation of the tumor. Furthermore, by providing a guide on the suction molding cup itself that can identify the tumor's position and positioning the radiation source along this guide, optimal three-dimensional positioning of the radiation source can be achieved using simple equipment.

[0005] Furthermore, Non-Patent Document 1 describes a 3D (dimensional) printed surgical guide used in breast-conserving surgery for breast cancer patients. When a breast cancer patient who has undergone chemotherapy undergoes breast-conserving surgery, the breast and tumor are 3D modeled based on MRI images taken in the same position as during surgery, and a surgical guide is manufactured and applied using a 3D printer, allowing the extent of the breast tumor to be accurately marked.

[0006] Japanese Patent Application Laid-Open No. 2018-134219

[0007] Zhen-Yu Wu et al. “Breast-conserving surgery with 3D-printed surgical guide: a single-center, prospective clinical study,” Sci Rep. 2021 Jan 26;11(1):2252.

[0008] The suction molding cup of Patent Document 1 is for radiation therapy, and the surgical guide of Non-Patent Document 1 is for marking by injecting dye, but in either case it is not easy to accurately approach the affected area in the soft tissue at the appropriate depth and angle, and further ingenuity is required. The object of this disclosure is to provide a puncture guide that appropriately adjusts the depth and angle of the puncturing needle to accurately and easily puncture the affected area.

[0009] The puncture guide of the present disclosure is a puncture guide comprising: a connector that guides a base portion having a needle and has a recess that adjusts the depth of puncture by the needle; and a main body shaped to fit the outer shape of a part of the body.

[0010] The above-described configuration provides a puncture guide that guides a needle attached to the base to a part of the body at an appropriate depth and angle, and accurately and easily punctures the affected area. Here, the main body may be shaped to reproduce the shape of an MRI image, CT image, 3D image, or other image taken.

[0011] The puncture guide of the present disclosure is characterized in that the body part is the chest.

[0012] With the above configuration, the puncture guide can be applied to soft tissues such as the female breast, and can be used for examination, diagnosis, and treatment of breast cancer patients for breast-conserving surgery, for example.

[0013] The puncture guide of the present disclosure is characterized in that it has a protrusion or step inside the recess, and the protrusion or step adjusts the puncture depth of the needle attached to the base.

[0014] With the above configuration, the insertion position of the puncture guide within the connector at the base can be adjusted appropriately, so that the affected area can be punctured accurately and easily.

[0015] The puncture guide of the present disclosure is characterized in that the main body has irregularities that indicate the course of blood vessels in the body.

[0016] With the above configuration, the surgeon can predict areas that require special attention and are prone to bleeding before proceeding with surgery.

[0017] The puncture guide of the present disclosure is characterized in that the main body has a softness similar to that of the body.

[0018] With the above-described configuration, the main body 10 deforms in accordance with the deformation of the body during surgery, so that the resection position does not shift.

[0019] The puncture guide of the present disclosure is characterized in that the base is a syringe and injects a dye into the part of the body.

[0020] With the above configuration, the puncture guide can be used for preoperative marking.

[0021] The puncture guide of the present disclosure is characterized in that the connector and the main body are integrated together.

[0022] With the above configuration, the spatial arrangement of the main body and connector of the puncture guide is fixed, and the angle of entry of the puncturing needle can be adjusted and fixed appropriately, so that the affected area can be punctured accurately and easily.

[0023] The method for manufacturing a puncture guide according to the present disclosure is characterized in that the main body and the connector of the puncture guide are designed using an MRI image, a CT image, a 3D image or other image of the body part, and are manufactured using a 3D printer.

[0024] With the above configuration, a puncture guide can be manufactured using a 3D printer based on an MRI image, a CT image, a 3D image, or other image prior to examination, diagnosis, or treatment.

[0025] The puncture guide manufacturing device of the present disclosure is a puncture guide manufacturing device comprising: an image acquisition unit that acquires MRI images, CT images, 3D images or other images of the affected area of ​​a patient; an automatic affected area detection unit that uses image analysis to detect the affected area from the MRI images, CT images, 3D images or other images; a 3D model generation unit for the affected area that generates a 3D model of the affected area; an individual puncture guide design unit that designs the puncture guide according to claim 1 that guides needle puncture into the affected area; a 3D model generation unit for the puncture guide that generates a 3D model of the puncture guide; and a reproducibility evaluation unit that uses image analysis to compare the 3D model of the puncture guide with the MRI images, CT images, 3D images or other images and the 3D model of the affected area and evaluate whether examination, diagnosis and treatment are appropriate.

[0026] The above configuration provides a puncture guide manufacturing device that manufactures puncture guides that can accurately and easily puncture an affected area by appropriately adjusting and fixing the depth and angle of a puncturing needle.

[0027] In the puncture guide manufacturing device of the present disclosure, the MRI image, CT image, 3D image or other image is characterized in that it shows the condition after treatment by RFA cauterization or chemotherapy.

[0028] With the above configuration, the puncture guide device can be manufactured based on a surgical plan.

[0029] The puncture guide device of the present disclosure is characterized by including a 3D image data transmission unit for determining, using the 3D image, whether the manufactured puncture guide is appropriately positioned using AR (Augmented Reality).

[0030] With the above configuration, it is possible to use AR to indicate the position where the puncture guide is to be placed in the real world.

[0031] The present disclosure makes it possible to provide a puncture guide that allows the depth and angle of a puncturing needle to be appropriately adjusted and fixed, allowing the affected area to be punctured accurately and easily.

[0032] Fig. 1 is a schematic diagram of a puncture guide provided with a plurality of connectors according to an embodiment; Fig. 2 is a diagram showing a state in which a syringe according to an embodiment is attached to a connector; Fig. 3 is a diagram showing a joint between a connector and a main body according to an embodiment; Fig. 4 is a block diagram showing a configuration of a puncture guide manufacturing device according to an embodiment; Fig. 5 is a schematic diagram in which a blood vessel running pattern is transferred onto a puncture guide according to an embodiment.

[0033] Embodiments Hereinafter, embodiments of the present invention will be described with reference to the drawings. However, the invention according to the claims is not limited to the following embodiments. Furthermore, not all of the configurations described in the embodiments are necessarily essential as means for solving the problems. For clarity of explanation, the following description and drawings have been omitted and simplified as appropriate. In each drawing, the same elements are given the same reference numerals, and repeated explanations are omitted as necessary.

[0034] (Explanation of Puncture Guide According to the Embodiment) A puncture guide according to the embodiment will be described with reference to FIGS. 1 to 3 and 5. FIG. 1 is a schematic diagram of a puncture guide having a plurality of connectors according to the embodiment. FIG. 2 is a diagram showing a state in which a syringe according to the embodiment is attached to a connector. FIG. 3 is a diagram showing a joint between a connector and a main body according to the embodiment. FIG. 5 is a schematic diagram of a puncture guide according to the embodiment in which a blood vessel pattern has been transferred. The puncture guide 1 according to the present disclosure is used for preoperative marking in surgical operations such as resection of a part of the body. The puncture guide 1 according to the present disclosure is also used for placing a depot agent, taking biopsy tissue, and irradiating radio waves.

[0035] As shown in FIG. 1 , the puncture guide 1 according to the embodiment includes a main body 10 and a connector 20. The main body 10 is formed of, for example, a resin such as plastic. The main body 10 has a shape that fits the outer shape of a body part. In other words, the main body 10 is a member shaped so that, when applied to a body part to be examined, diagnosed, or treated, the body part reproduces the shape of the body part when an MRI image, CT image, 3D image, or other image is taken. The body part is, for example, a human chest.

[0036] By using a main body 10 that conforms to the external shape of a body part, pressure is applied to the entire soft tissue, such as a human breast, making it less likely to deform during examination, diagnosis, or treatment. The main body 10 can also be said to fix the shape of the soft tissue, provide strength with less material, and support the connector 20. Although not shown, the main body 10 can be made to have excellent strength with less material by, for example, forming a hexagonal mesh structure. By taking MRI images, CT images, 3D images, or other images in the same posture and position as during examination, diagnosis, or treatment, and designing based on these images, it is possible to manufacture a main body 10 that reproduces the external shape of the body part at the time of taking the MRI images, CT images, 3D images, or other images during examination, diagnosis, or treatment.

[0037] The material of the main body 10 may be made to have the same softness as the body. For example, rubber or the like may be used as the material of the main body 10. In this way, the main body 10 will deform in accordance with the deformation of the body during surgery, preventing the resection position from shifting. The main body 10 may be a uniformly formed object without any holes, or may be an object with holes arranged in a lattice pattern.

[0038] The main body 10 is fitted with a connector 20 having a recess 21 for guiding the base at an appropriate angle and a tip 22 for adjusting and fixing the puncture depth of the needle attached to the base. The base may be a syringe 30 for administering a drug, a device for collecting a sample, or a device for generating electromagnetic waves. The base of the puncture guide 1 is a syringe for administering a drug, the main body of a biopsy needle, the handle of an electrode needle, etc., and the needle attached to the base punctures the affected area.

[0039] The syringe 30 is used for preoperative marking by injecting a dye, and is also used for injecting, for example, an anticancer drug into an appropriate site, for example, for placing a depot drug.

[0040] Furthermore, the puncture guide 1 of the present disclosure can collect a sample from a part of the body through a needle if the base is a device for collecting a sample.

[0041] Furthermore, if the puncture guide 1 of the present disclosure has a base that generates electromagnetic waves, a radiofrequency ablation (RFA) needle can be inserted using this connector 20. In this case, by designing the size and shape of the recess 21 of the connector to fit the handle of the RFA needle, the puncture depth and angle of the RFA needle can be adjusted and fixed, allowing for accurate and easy irradiation of radiofrequency waves.

[0042] Here, the base will be described using the syringe 30 as an example. The main body 10 may be provided with one connector 20 or with multiple connectors 20. With multiple connectors 20, examination and treatment can be performed on multiple locations on a body part.

[0043] As shown in FIG. 2 , the connector 20 includes a recess 21 and a tip 22. The recess 21 and the tip 22 are distinguished by different shapes that fix the insertion position of the base in the connector 20. The outer cylinder of the syringe 30 is inserted into and fixed in the recess 21 of the connector 20. The recess 21 of the connector 20 has a size and shape that matches the outer shape of the syringe 30. Therefore, the recess 21 is preferably hollow cylindrical or truncated conical so as to fit a typical syringe 30. However, the recess 21 is not limited thereto, and the cross section may be triangular, rectangular, or polygonal.

[0044] The tip portion 22 of the connector 20 is hollow and is the portion through which the needle attached to the syringe 30 passes. The tip portion 22 of the connector 20 is preferably a truncated cone or a cylinder having a diameter smaller than that of the recess 21. However, the shape of the tip portion 22 is not limited thereto, and the cross section may be triangular, rectangular, or polygonal.

[0045] The length of the tip portion 22 of the connector 20 changes depending on the length of the needle of the syringe 30 and the depth to which the drug is to be administered. That is, the length of the tip portion 22 of the connector 20 changes depending on the length of the needle of the syringe 30 and the depth to which the drug is to be punctured. Furthermore, protrusions or steps may be formed in multiple stages inside the recess 21 of the connector 20. When punctures at multiple depths are required at the same angle, the recess 21 is provided with protrusions or steps inside so that the base can be fixed at multiple positions. The protrusions or steps serve as a stopper for the tip of the outer cylinder of the syringe 30, allowing the puncture depth of the needle of the syringe 30 to be adjusted and fixed in multiple stages.

[0046] The puncture angle of the connector 20 is determined in advance when the puncture guide 1 is designed. This is because the affected area, which is the puncture target, has a three-dimensional shape, and the area is identified by MRI images, CT images, 3D images, or other images taken before examination, diagnosis, or treatment. The connector 20 is coupled to the main body 10 at an appropriate puncture angle. In this way, the puncture guide 1, which fits the outer shape of the body part, can guide the needle attached to the syringe 30 to the body part at an appropriate depth and angle, allowing the affected area to be punctured accurately and easily.

[0047] The connector 20 may be integral with the main body 10 or may be separate. As shown in FIG. 1 , if the connector 20 is integral with the main body 10, the main body 10 and the connector 20 can be integrally molded. Information regarding the size and shape of the connector 20 is stored in advance in an information processing device according to the size and shape of the base to be guided. By acquiring MRI images, CT images, 3D images, or other images of the affected area and a part of the body, the puncture depth and angle of the syringe 30 can be determined based on the MRI images, CT images, 3D images, or other images. Therefore, the puncture guide 1 in which the connector 20 and the main body 10 are integrated is designed by acquiring MRI images, CT images, 3D images, or other images. The puncture guide 1 in which the connector 20 and the main body 10 are integrated can be manufactured using a 3D printer based on the design.

[0048] The manufacturing method of the puncture guide 1 is, for example, as follows: First, an MRI image, a CT image, a 3D image, or other image is taken at a location where no manufacturing device for the puncture guide 1 is available, such as a hospital. Then, an information processing device acquires the MRI image, CT image, 3D image, or other image as electronic data by electrical means at a location away from the imaging location, such as a location where a 3D printer is installed. Finally, the puncture guide 1 is manufactured based on the electronic data at the location where the 3D printer is installed.

[0049] As shown in FIG. 3 , if the connector 20 is separate from the main body 10, the connector 20 can be joined to another main body 10, allowing the connector 20 to be used with various main bodies 10. In other words, another connector 20 can be joined to the connector portion of the main body 10, and various connectors 20 can be applied to the connector portion of the main body 10. By changing the length of the tip 22 of the connector 20, the puncture depth of the syringe 30 can be changed. Furthermore, the angle between the connector 20 and the main body 10 may be adjustable and fixed in several ways at the joint 40. By changing the angle of the connector 20 using the adjustable and fixable joint 40, the puncture angle of the syringe 30 can be changed. In this way, by providing the joint 40 as a separate, adjustable and fixable body, the puncture angle at the connector portion can be adjusted.

[0050] FIG. 5 shows a puncture guide that does not include the connector and has added irregularities 501 that mimic the running of blood vessels. As shown in FIG. 5, the main body 10 of the puncture guide may be provided with irregularities 501 that mimic the running of blood vessels. Blood vessels exist inside the body and cannot be seen from the outside, but can be confirmed using MRI images, CT images, etc. The irregularities 501 clearly indicate the blood vessels contained in the body tissue. This allows the surgeon to predict areas that require attention and are prone to bleeding before proceeding with surgery.

[0051] Furthermore, an opening such as a window for inserting an ultrasonic examination device may be provided in the main body 10. The ultrasonic examination device is placed on the affected area to perform an ultrasonic examination of the affected area.

[0052] When designing the puncture guide, the three-dimensional size and shape of the target site (e.g., resection area) are taken into consideration, and the puncture depth is shortened as much as possible to reduce the degree of invasiveness. If there are multiple target sites, the angles of the main body 10 and the connector 20 are adjusted by the joint 40 so that the needles attached to the base reach the target sites without crossing each other. The angles of the connectors 20 are adjusted so that even a single puncture can be performed minimally invasively, and even multiple punctures can be performed three-dimensionally independently minimally invasively. By using the above configuration to "guide the base equipped with the needle at an appropriate angle," the puncture guide 1 is attached to a part of the body, and the base equipped with the needle is guided to the connector 20 of the puncture guide, and the needle attached to the base reaches the target site in a fixed manner.

[0053] In designing the puncture guide, the size, length, and shape of the recess 21 and tip 22 of the connector 20 are adjusted based on the size and shape of the base and the length of the needle attached to the base, while taking into consideration the thicknesses of the main body 10 and the joint 40, so that the base is smoothly guided and fixed in the recess 21 of the connector 20 and the needle attached to the base reaches the target site (e.g., the resection area). By using the above configuration to "adjust and fix the needle puncture depth to an appropriate depth," the puncture guide 1 is attached to a part of the body, and the base with the attached needle is guided into the connector 20 of the puncture guide, so that the needle attached to the base reaches the target site in a fixed manner.

[0054] The puncture guide 1 in which the connector 20, the joint 40, and the main body 10 are separate bodies is manufactured in accordance with the manufacturing method described above.

[0055] (Explanation of a puncture guide manufacturing device according to an embodiment) FIG. 4 is a block diagram showing the configuration of a puncture guide manufacturing device according to an embodiment. The puncture guide manufacturing device according to an embodiment will be described with reference to FIG. 4. The puncture guide manufacturing device 400 is used, for example, to manufacture a puncture guide 1 that applies pre-operative marking to an affected area in breast-conserving surgery. As exemplified above, the puncture guide 1 may guide a needle for placing a depot agent, a needle for collecting a sample, or a needle for outputting radio waves. Here, the manufacture of a puncture guide 1 for pre-operative marking will be described as an example.

[0056] The puncture guide manufacturing device 400 includes an image acquisition unit 401, an automatic detection unit for an affected area by image analysis 402, a 3D model generation unit for the affected area 403, an automatic design unit for a target site (resection range) 404, a manual adjustment unit for the target site (resection range) 405, an individual design unit for a puncture guide 406, a 3D model generation unit for a puncture guide 407, a surgical plan storage and editing unit 408, a reproducibility evaluation unit by image analysis 409, and an information sharing unit between doctors 410. The puncture guide manufacturing device 400 may include some, but not all, of these units.

[0057] The image acquisition unit 401 acquires MRI images, CT images, 3D images, or other images of a patient having an affected area taken in a hospital. The image acquisition unit 401 acquires electronic data of the MRI images, CT images, 3D images, or other images via a network such as the Internet or a LAN (Local Area Network) or by using a storage medium such as a memory.

[0058] The 3D image shows the outline of the patient. The 3D image can be used to position the puncture guide during surgery. For example, the position where the puncture guide is to be placed can be shown in the real world using AR (Augmented Reality). This AR display is preferably performed on the surgeon's mobile device during surgery. The surgeon determines the position of the puncture guide using a mobile device such as a smartphone or tablet. For this reason, the puncture guide manufacturing device 400 includes a 3D image data transmission unit that transmits the 3D image to the mobile device.

[0059] The MRI, CT, 3D, or other images may show the condition after RFA ablation or chemotherapy treatment, so that the needle guide device can be manufactured based on the surgical plan.

[0060] The unit 402 for automatically detecting an affected area by image analysis automatically detects an affected area by image analysis using machine learning artificial intelligence (AI (Artificial Intelligence)).

[0061] The affected area 3D model generation unit 403 generates a 3D model of the affected area that is automatically detected using technology such as 3D CAD.

[0062] The automatic design unit 404 of the target site (resection range) automatically designs the resection range of the affected area. The automatic design unit 404 of the target site (resection range) can design the resection range by setting the resection range to, for example, 1 cm around the affected area. If the puncture guide 1 is not used to resect the affected area, the automatic design unit 404 of the target site (resection range) may not be required.

[0063] The manual adjustment unit 405 for the target site (resection range) has a function to manually adjust the resection range of the affected area. The affected area calculated by the information processing device may be difficult to resect and may not be appropriate for surgery. Also, the affected area detected by the automatic affected area detection unit 402 using image analysis may not be appropriate. Therefore, a function is required for the surgeon or a physician involved in the surgery to manually adjust the resection range. If the puncture guide 1 is not used to resect the affected area, this manual adjustment unit 405 for the target site (resection range) may not be necessary.

[0064] The individual puncture guide design unit 406 designs the puncture guide 1, which is composed of a main body 10 that fits the external shape of a body part, a connector 20 in which the depth and angle of the needle to puncture the affected area are set, and a joint 40. Information regarding the size and shape of the connector 20 is stored in advance in an information processing device according to the size and shape of the guiding base. The puncture guide 1 is used to mark the resection area on the patient before surgery. The puncture guide 1 may also guide a needle for placing a depot drug, a needle for collecting a sample, or a needle for outputting radio waves.

[0065] The puncture guide 3D model generation unit 407 generates a 3D model so that the puncture guide 1 can be printed by a 3D printer. The 3D model generated by the 3D model generation unit is printed by a 3D printer connected to the puncture guide manufacturing device via the Internet, a LAN, or directly. Therefore, the puncture guide manufacturing device 400 of the present disclosure may be located away from the hospital and away from the 3D printer.

[0066] The surgical plan storage and editing unit 408 is a part that has a function for the surgeon or a doctor involved in the surgery to store and edit the surgical plan. The surgical plan storage and editing unit 408 is preferably provided in the puncture guide manufacturing device 400, but does not have to be provided when manufacturing the puncture guide 1.

[0067] The image analysis reproducibility evaluation unit 409 compares the completed 3D model of the puncture guide 1 with an MRI image, a CT image, a 3D image, or other images, or a 3D model of the affected area, and evaluates whether the surgery is appropriate. The image analysis reproducibility evaluation unit 409 may also evaluate whether the positions of the preoperative markings, the placement position of the depot drug, the position of the sample collection, and the position of the radiofrequency output needle are appropriate.

[0068] The inter-doctor information sharing unit 410 is a part for sharing information between the surgeon and other doctors involved in the surgery. The inter-doctor information sharing unit 410 is preferably provided in the puncture guide manufacturing device 400, but does not have to be provided when manufacturing the puncture guide 1.

[0069] The puncture guide manufacturing device 400 is realized by an information processing device. The information processing device includes a processor (e.g., a CPU) that executes a program for processing information and a memory that stores the program. The information processing device may be a single device or may be configured across multiple devices. The information processing device may be configured as a cloud server that executes some or all of its functions in a distributed manner.

[0070] Furthermore, part or all of the processing in the puncture guide manufacturing apparatus 400 described above can be realized as a computer program. Such a program can be stored using various types of non-transitory computer-readable media and supplied to a computer. Non-transitory computer-readable media include various types of tangible recording media. Examples of non-transitory computer-readable media include magnetic recording media (e.g., flexible disks, magnetic tapes, hard disk drives), magneto-optical recording media (e.g., magneto-optical disks), CD-ROMs (Read Only Memory), CD-Rs, CD-R / Ws, and semiconductor memories (e.g., mask ROMs, PROMs (Programmable ROMs), EPROMs (Erasable PROMs), flash ROMs, and RAMs (Random Access Memory)). Furthermore, the program may be supplied to a computer by various types of temporary computer-readable media. Examples of temporary computer-readable media include electrical signals, optical signals, and electromagnetic waves. The temporary computer-readable medium can supply the program to the computer via a wired communication path such as an electric wire or an optical fiber, or via a wireless communication path.

[0071] The present invention is not limited to the above-described embodiment, and can be modified as appropriate within the scope of the present invention. For example, the puncture guide 1 of the present disclosure is intended to be applied to the chest of a woman, such as a breast cancer patient, but can also be used in other parts of the body that are made of soft tissue.

[0072] This application claims priority based on Japanese Patent Application No. 2023-98361, filed on June 15, 2023, the disclosure of which is incorporated herein in its entirety.

[0073] The puncture guide of the present disclosure can be used in surgical operations. The puncture guide manufacturing device is used to manufacture the puncture guide.

[0074] DESCRIPTION OF SYMBOLS 1 Puncture guide, 10 Main body, 20 Connector, 21 Recess, 22 Tip, 30 Syringe, 40 Joint, 400 Puncture guide manufacturing device, 401 Image acquisition unit, 402 Automatic detection unit of affected area by image analysis, 403 3D model generation unit of affected area, 404 Automatic design unit of target area (resection range), 405 Manual adjustment unit of target area (resection range), 406 Individual design unit of puncture guide, 407 3D model generation unit of puncture guide, 408 Storage and editing unit of surgical plan, 409 Reproducibility evaluation unit by image analysis, 410 Information sharing unit between doctors, 501 Concave and concave

Claims

1. A puncture guide comprising: a connector having a recess for guiding a base having a needle and adjusting the depth of puncture by the needle; and a body shaped to fit the contour of a part of the body.

2. The puncture guide of claim 1, wherein the body part is a chest.

3. The puncture guide according to claim 1, wherein the inside of the recess is provided with a protrusion or a step, and the protrusion or step adjusts the puncture depth of the needle attached to the base.

4. The puncture guide according to claim 1, wherein the main body has projections and recesses representing the vascular course of the body.

5. The puncture guide according to claim 1, wherein the main body has a softness similar to that of the human body.

6. The puncture guide of claim 1, wherein the base is a syringe for injecting dye into the body part.

7. The puncture guide of claim 1, wherein the connector and the main body are integrated.

8. A method for manufacturing a puncture guide, comprising: designing the main body and the connector of the puncture guide according to claim 7 using an MRI (Magnetic Resonance Imaging) image, a CT (Computed Tomography) image, a 3D (Dimensional) image or other image of the part of the body; and manufacturing the body using a 3D printer.

9. A puncture guide manufacturing device comprising: an image acquisition unit which acquires an MRI image, a CT image, a 3D image or other image of a patient's affected area; an automatic affected area detection unit which uses image analysis to detect the affected area from the MRI image, the CT image, the 3D image or other image; a 3D model generation unit for the affected area which generates a 3D model of the affected area; an individual puncture guide design unit which designs the puncture guide according to claim 1 which guides the insertion of a needle into the affected area; a 3D model generation unit for the puncture guide which generates a 3D model of the puncture guide; and a reproducibility evaluation unit which uses image analysis to compare the 3D model of the puncture guide with the MRI image, CT image, 3D image or other image and the 3D model of the affected area and evaluate whether examination, diagnosis and treatment are appropriate.

10. The puncture guide manufacturing device according to claim 9, wherein the MRI image, CT image, 3D image or other image shows a condition after RFA cauterization or chemotherapy treatment.

11. The puncture guide manufacturing device according to claim 9, further comprising a 3D image data transmission unit for using the 3D image to determine, using augmented reality (AR), whether or not the manufactured puncture guide is properly positioned.