Lesion site identification method, organ covering sheet and manufacturing method of organ covering sheet

Abstract

To provide a lesion site identification method capable of safely identifying a lesion site of an organ by suppressing exposure to radiation and pain of a patient.SOLUTION: A lesion site identification method includes the steps of: creating, on the basis of data obtained by lung CT scan, a life-size pulmonary lobe model of a pulmonary lobe including a lesion site by a 3D printer, the pulmonary lobe model representing a position corresponding to the lesion site on an outer shell thereof; covering the pulmonary lobe model with a PGA sheet, transferring a shape of the pulmonary lobe model onto the PGA sheet, and creating a pleural sheet by fixing it with fibrin glue; marking the pleural sheet at a position corresponding to the lesion site of the pulmonary lobe; covering the pulmonary lobe with the marked pleural sheet; and identifying the lesion site on the basis of the mark on the pleural sheet covering the pulmonary lobe.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a lesion site identification method for identifying a lesion site in an organ when performing surgery to remove a part of the organ by inserting an endoscope into a space inside the body, an organ dressing sheet for use in the lesion site identification method, and a method for manufacturing the organ dressing sheet. [Background technology]

[0002] In lung cancer and metastatic lung tumor surgery, a thoracoscope, a type of endoscope, is typically inserted into the chest cavity and used to perform a partial lung resection (wedge resection) or segmentectomy. While identifying the location of the lesion is necessary during such partial lung resections and segmentectomies, it can be difficult to palpate minute lesions or lesions located deep within the lungs using a small thoracotomy (1.0-2.0 cm) incision under thoracoscopy.

[0003] As a method that enables the location of the lesion to be identified even in such cases, CT (Computed Tomography)-guided dye marking is widely used as a simple procedure (see, for example, Non-Patent Document 1). CT-guided dye marking is a method in which a needle is inserted near the location of the lung lesion under CT fluoroscopy before surgery, and a dye is injected.

[0004] Alternative methods to CT-guided dye marking include the VAL-MAP (Virtual-Assisted Lung MAPping) method (see, for example, Non-Patent Document 2) and the placement of an RFID (Radio Frequency IDentification) tag (see, for example, Non-Patent Document 3).

[0005] The VAL-MAP method uses a virtual bronchoscopic image reconstructed from a CT image taken in advance to inject dye into multiple locations around the lesion using a bronchoscope while also using X-ray fluoroscopy before surgery.The RFID tag placement method involves identifying the lesion using a bronchoscope while also using X-ray fluoroscopy before surgery, and then placing an RFID tag at the lesion.The location of the lesion is identified during surgery by detecting the signal from the RFID tag with an antenna inserted under the thoracic cavity. [Prior art documents] [Non-patent literature]

[0006] [Non-Patent Document 1] Takashi Yanagimoto, et al., "Retrospective observational study of CT-guided marking before lung resection," Journal of the Japanese Association for Thoracic Surgery, Japanese Association for Thoracic Surgery, March 2023, Vol. 37, No. 2, pp. 85-92 [Non-patent document 2] Masaaki Sato, et al., “Safety and reproducibility of virtual-assisted lung mapping: a multicentre study in Japan”, European Journal of Cardio-Thoracic Surgery, 2017, vol.51, no.5, p.861- 868 [Non-patent document 3] Hiromi Takabatake and 7 others, "Micro-Tumor Marking System for Endoscopic Surgery Support Using Ultra-Small RFID Tags", Biomedical Engineering, Japanese Society for Medical and Biological Engineering, 2012, Vol. 50, No. 6, pp. 658-665 Summary of the Invention [Problem to be solved by the invention]

[0007] CT-guided dye marking involves marking under CT transmission, which poses a risk of radiation exposure for patients and medical personnel. Furthermore, CT-guided dye marking requires approximately one hour between marking the lesion location and the start of surgical resection. During this time, the injected dye may be absorbed and diffused throughout the body, making it difficult to identify the lesion location. Furthermore, because CT-guided dye marking is performed through the chest wall, it can be affected by chest wall structures (ribs, scapulae, arteries and veins), making marking around the lesion difficult. Furthermore, CT-guided dye marking involves puncturing the lungs to inject the dye, which can be painful for patients and poses a risk of complications such as pneumothorax, bleeding, and air embolism.

[0008] As with CT-guided dye marking, the VAL-MAP method requires time from marking to surgery, which can lead to the dye diffusing before surgery, making it difficult to identify the location of the lesion, and there is a risk of pain to the patient and complications due to needle puncture.In addition, the VAL-MAP method is performed under X-ray fluoroscopy, which raises the issue of radiation exposure to patients and medical staff, and there is also the issue of pain to patients caused by the bronchoscope.

[0009] Methods using RFID tags also have problems such as exposure of patients and medical staff to radiation due to X-ray fluoroscopy, and pain to patients due to bronchoscopy, as well as the possibility of RFID tags remaining behind.

[0010] The present invention has been made to solve the above problems, and aims to provide a lesion site identification method, an organ dressing sheet, and a method for manufacturing an organ dressing sheet that can safely identify lesion sites in organs while minimizing radiation exposure and pain to patients. [Means for solving the problem]

[0011] To achieve this object, a first aspect of the present invention is a lesion identification method for identifying a lesion in an organ when performing surgery to remove a part of an organ by inserting an endoscope into a space inside the body, the method comprising: an organ model creation step of creating, using a 3D printer, a life-size organ model of at least a part of the organ including the lesion, based on data obtained by computed tomography of the organ, the organ model having a position corresponding to the lesion indicated on its outer shell; an organ covering sheet creation step of covering the organ model with a sheet, transferring the shape of the organ model to the sheet and fixing it with an adhesive, to create an organ covering sheet; a marking step of applying a mark to the organ covering sheet at a position corresponding to the lesion in the organ; a covering step of covering the organ with the organ covering sheet with the mark; and an identification step of identifying the lesion based on the mark on the organ covering sheet applied to the organ.

[0012] In a second aspect of the present invention, in the method for identifying a lesion site according to the first aspect, the covering step involves inserting the organ covering sheet with the markings in a folded state into the body through a port provided in the wound, and then restoring the organ covering sheet inside the body to cover the organ.

[0013] A third aspect of the present invention is a method for identifying a lesion site according to the first or second aspect, wherein the marking step comprises punching holes in the organ covering sheet at positions corresponding to the lesion site of the organ as the mark, and the identification step comprises making a predetermined marking on the organ visible through the hole in the organ covering sheet covering the organ, thereby identifying the lesion site.

[0014] A fourth aspect of the present invention is the method for identifying a lesion site according to any one of the first to third aspects, wherein the adhesive is fibrin glue.

[0015] A fifth aspect of the present invention is the method for identifying a lesion site according to any one of the first to fourth aspects, wherein the sheet is a polyglycolic acid sheet or a glycolic acid / lactic acid polyester mesh.

[0016] A sixth aspect of the present invention is a method for identifying a lesion site according to any one of the first to fifth aspects, wherein the organ model creation step creates the organ model using the 3D printer with transparent resin as a material.

[0017] A seventh aspect of the present invention is a method for identifying a lesion site according to any one of the first to sixth aspects, wherein the organ is a lung, the organ model creation step creates a life-size organ model of a lung lobe including the lesion site, and the covering step covers the lung in a collapsed state by one-lung ventilation with the organ covering sheet bearing the mark, and then inflates the lung by two-lung ventilation.

[0018] An eighth aspect of the present invention is a method for identifying a lesion site according to the seventh aspect, wherein the organ model creation step represents the boundaries between the lung regions in the organ model based on data obtained by the computed tomography, and the marking step further marks the organ covering sheet at positions corresponding to the boundaries between the lung regions.

[0019] A ninth aspect of the present invention is an organ covering sheet comprising a sheet portion onto which the shape of at least a part of an organ including a lesion site is transferred, and a mark affixed to the sheet portion at a position corresponding to the lesion site, and by covering the organ with the sheet portion, the lesion site can be identified from the position of the mark.

[0020] A tenth aspect of the present invention is the organ covering sheet according to the ninth aspect, wherein the sheet part is configured so as to be able to restore the shape of at least a part of the transferred organ from a folded state.

[0021] An eleventh aspect of the present invention is a method for manufacturing an organ covering sheet that covers an organ including a lesion site to identify the lesion site of the organ, the method comprising: an organ model creation step of creating, using a 3D printer, a life-size organ model of at least a part of the organ including the lesion site based on data obtained by computed tomography of the organ, the organ model having a position corresponding to the lesion site indicated on its outer shell; an organ covering sheet creation step of covering the organ model with a sheet, transferring the shape of the organ model to the sheet, and fixing it with an adhesive, to create an organ covering sheet; and a marking step of applying a mark to the organ covering sheet at a position corresponding to the lesion site of the organ. [Effects of the Invention]

[0022] According to the first aspect of the present invention, the method for identifying a lesion site includes: first, in an organ model creation step, a full-size organ model of at least a portion of an organ, including a lesion site, is created using a 3D printer based on data obtained by computed tomography of the organ, the organ model having a location corresponding to the lesion site indicated on its outer shell; then, in an organ covering sheet creation step, a sheet is placed over the organ model, the shape of the organ model is transferred to the sheet, and the sheet is fixed with an adhesive, thereby creating an organ covering sheet that mimics the shape of at least a portion of a patient's organ; then, in a marking step, a mark is placed on the organ covering sheet at a location corresponding to the lesion site of the organ; then, in a covering step, the organ is covered with the marked organ covering sheet; and then, in an identification step, the lesion site in the organ is identified based on the mark on the organ covering sheet that has been placed over the organ. In this way, an organ covering sheet is created from an organ model that mimics each patient's organ, and the organ is covered with the organ covering sheet to identify the lesion site, thereby achieving the effect of easily and accurately identifying the lesion site. Furthermore, CT or X-ray fluoroscopy is not required when marking the lesion, and there is no need to use a bronchoscope. Furthermore, lesions can be identified without the need for needle punctures to inject dye into the lesion or the placement of RFID tags. This reduces radiation exposure and pain to the patient, and has the effect of safely identifying lesions in organs.

[0023] The lesion site identification method according to the second aspect of the present invention has the following effect in addition to the effects of the lesion site identification method according to the first aspect: In the covering step, the marked organ covering sheet is inserted into the body in a folded state through a port provided in the wound, and the organ covering sheet is restored inside the body to cover the organ. This has the effect of allowing the organ covering sheet to be inserted into the body through a small incision made to insert an endoscope into a space inside the body for surgery and to cover the organ.

[0024] The lesion site identification method according to the third aspect of the present invention has the following effect in addition to the effects of the lesion site identification method according to the first or second aspect. That is, in the marking step, holes are made in the organ covering sheet at positions corresponding to the lesion site of the organ. Then, in the identification step, the lesion site is identified by making a predetermined marking on the organ visible through the hole in the organ covering sheet covering the organ. This has the effect of allowing the lesion site of the organ to be marked safely and easily.

[0025] The lesion site identification method according to the fourth aspect of the present invention achieves the following effect in addition to the effects achieved by the lesion site identification method according to any one of the first to third aspects. Specifically, in the organ covering sheet creation step, the shape of the organ model transferred to the sheet is fixed with fibrin glue to create an organ covering sheet. This has the effect of allowing the organ covering sheet, with the shape of the organ model fixed by fibrin glue, to be easily peeled off from the organ covering sheet. Furthermore, the use of fibrin glue makes the organ covering sheet flexible, thereby enabling the organ covering sheet to be easily and reliably placed over an organ in the identification step. Furthermore, fibrin glue has traditionally been used as an adhesive for adhering biological tissues, and there is no problem if it remains in the body. Therefore, even if an organ is covered with an organ covering sheet, with the shape of the organ model fixed by fibrin glue, it can be used safely.

[0026] The lesion site identification method according to the fifth aspect of the present invention achieves the following effect in addition to the effects achieved by the lesion site identification method according to any one of the first to fourth aspects. Specifically, the organ covering sheet is made of a polyglycolic acid sheet or a glycolic acid / lactic acid polyester mesh. This allows the organ covering sheet to be flexible, which has the effect of allowing the organ covering sheet to be easily and reliably placed over the organ in the identification step. Furthermore, polyglycolic acid sheets or glycolic acid / lactic acid polyester meshes have traditionally been used in vivo, and no problems arise if they are left in the body. Therefore, there is the effect that the organ covering sheet can be used safely even when it is used to cover an organ.

[0027] The lesion site identification method according to the sixth aspect of the present invention achieves the following effect in addition to the effect achieved by the lesion site identification method according to any one of the first to fifth aspects. That is, in the organ model creation step, the organ model is created by a 3D printer using a transparent resin as a material. Transparent resin can be sterilized. This allows the organ covering sheet to be created in a clean field using a sterilized organ model, thereby preventing the organ covering sheet from being contaminated with bacteria. Therefore, even if the organ is covered with the organ covering sheet, the patient can be prevented from becoming infected with bacteria.

[0028] The lesion site identification method according to the seventh aspect of the present invention achieves the following effect in addition to the effect achieved by the lesion site identification method according to any one of the first to sixth aspects. Specifically, in the organ model creation step, a full-size organ model of a lung lobe including a lesion site is created. Then, in the covering step, an organ covering sheet with a mark is placed on the collapsed lung by one-lung ventilation, making it easy to cover the lung with the organ covering sheet. Then, in the covering step, the lung is inflated by two-lung ventilation with the organ covering sheet placed on it. Here, the organ covering sheet is created based on data obtained by computed tomography of the inflated lung. Therefore, by inflating the lung with the organ covering sheet placed on it, the lesion site in the lung can be accurately identified from the mark placed on the organ covering sheet created based on the inflated lung. This has the effect of making it easy to cover the lung with the organ covering sheet and accurately identifying the lesion site in the lung.

[0029] The lesion site identification method according to the eighth aspect of the present invention achieves the following effects in addition to the effects achieved by the lesion site identification method according to the seventh aspect. Specifically, in the organ model creation step, the boundaries between lung sections are represented in the organ model based on data obtained by computed tomography. Then, in the marking step, marks are added to the organ covering sheet at positions corresponding to the borders between lung sections. This has the effect of making it possible to identify the borders between lung sections, which are difficult to distinguish with the naked eye, from the organ covering sheet placed over the lung. Furthermore, by adding marks to the organ covering sheet at positions corresponding to the lesion site and the borders between lung sections, it has the effect of making it possible to design a resection line from the organ covering sheet to ensure the distance between the lesion site and the lung resection position.

[0030] According to the organ covering sheet of the ninth aspect of the present invention, the sheet portion has a shape that transfers at least a portion of a patient's organ, including the lesion, so that the patient's organ can be easily covered with the sheet. Furthermore, since the sheet portion is marked at a position corresponding to the lesion, the organ covering sheet can be used to easily and accurately identify the lesion in the organ. Furthermore, by using this organ covering sheet, CT fluoroscopy or X-ray fluoroscopy is not required at the stage of marking the lesion, and a bronchoscope is not required. Furthermore, the lesion can be identified without the need for needle puncture for dye injection or placement of an RFID tag. Therefore, radiation exposure and patient pain can be reduced, and the lesion in the organ can be identified safely.

[0031] The organ covering sheet according to the tenth aspect of the present invention has the following effect in addition to the effect of the organ covering sheet according to the ninth aspect. That is, even when folded, the sheet portion restores to the shape of at least a part of the organ to which it is transferred. Therefore, the organ covering sheet can be inserted into the body in a folded state through a port provided in the wound, and can restore itself inside the body to cover the organ. This has the effect of allowing the organ covering sheet to be inserted into the body through a small incision made to insert an endoscope into a space inside the body for surgery, and to cover the organ.

[0032] In the method for producing an organ covering sheet according to the eleventh aspect of the present invention, first, in the organ model creation step, a full-size organ model of at least a portion of an organ, including a lesion, is created using a 3D printer based on data obtained by computed tomography of the organ, with the location of the lesion indicated on its outer shell. Next, in the organ covering sheet creation step, the organ model is covered with a sheet, and the shape of the organ model is transferred to the sheet and fixed with an adhesive, thereby creating an organ covering sheet that mimics the shape of at least a portion of a patient's organ. Next, in the marking step, a mark is applied to the organ covering sheet at a location corresponding to the lesion in the organ. This results in an organ covering sheet being created from the organ model that mimics each patient's organ, and then the organ is covered with the organ covering sheet to identify the lesion, thereby achieving the effect of easily and accurately identifying the lesion using the organ covering sheet. Furthermore, by using this organ covering sheet, CT or X-ray fluoroscopy is not required when marking the lesion, and there is no need to use a bronchoscope. Furthermore, lesions can be identified without the need for needle punctures to inject dye into the lesion or the placement of RFID tags. This has the effect of minimizing radiation exposure and patient discomfort, and enabling the safe identification of lesions in organs. [Brief explanation of the drawings]

[0033] [Figure 1] 1 is a flowchart showing an outline of the flow of a lesion site identification method according to a first embodiment of the present invention. [Figure 2] 10 is a flowchart showing a method for producing a pleural sheet, which is one step in the lesion site identification method. [Figure 3] (a) is a diagram showing a schematic representation of 3D data of a lung lobe, (b) is a diagram showing a full-scale lung lobe model created using a 3D printer, (c) is a diagram showing the lung lobe model covered with a PGA sheet, (d) is a diagram showing a pleural sheet onto which the outline of the lung lobe model has been transferred and fixed, and (e) is a diagram showing the pleural sheet with marks added at positions corresponding to the lesion site. [Figure 4] (a) is a diagram showing the pleural sheet in a folded state, and (b) is a diagram showing the pleural sheet restored from the folded state. [Figure 5] 1(a) is a flowchart showing a pleural sheet covering method, which is one step of the lesion site identification method, and FIG. 1(b) is a flowchart showing a lesion site identification method, which is one step of the lesion site identification method. [Figure 6] (a) to (c) are diagrams showing a schematic diagram of a method for covering with a pleural sheet, and (d) to (e) are diagrams showing a schematic diagram of a method for identifying a lesion site. [Figure 7] (a) is a diagram showing the creation of a pleural sheet using a created lung lobe model in a clinical trial; (b) is a diagram showing the state in which a specific marking was made on a lung lobe using a mark made on the pleural sheet; (c) is a diagram comparing the position of the specific marking made using the pleural sheet with the actual position of the center of the lesion site in an excised lung lobe; and (d) is a diagram comparing the position of the specific marking made using a pleural sheet created for another excised lung lobe with the actual position of the center of the lesion site in an excised lung lobe. [Figure 8] 10(a) is a diagram showing marks to be placed on a pleural sheet at positions corresponding to the lesion site and marks to be placed at positions corresponding to the boundary line between lung lobe regions in a lesion site identification method according to a second embodiment, and FIG. 10(b) is a diagram showing an ideal resection line for the lung lobe designed for the pleural sheet shown in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0034] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. Each of the embodiments described below illustrates a preferred specific example of the present invention. Therefore, the numerical values, shapes, materials, components, component placement and connection configurations, etc., shown in the following embodiments are merely examples and are not intended to limit the present invention. Therefore, among the components in the following embodiments, components that are not recited in the independent claims that represent the highest concept of the present invention will be described as optional components. Furthermore, in each drawing, substantially identical components are assigned the same reference numerals, and redundant explanations will be omitted or simplified.

[0035] <1. First embodiment> <1.1. Overview of the lesion site identification method> First, with reference to Figure 1, an outline of the flow of a lesion site identification method according to a first embodiment of the present invention will be described. Figure 1 is a flowchart showing an outline of the flow of this lesion site identification method. The lesion site identification method according to the first embodiment identifies a lesion site 2 (see Figure 7(c)) in lung 1, such as a tumor, when performing surgery to remove a part of lung 1 (see Figure 6) by inserting a thoracoscope into the thoracic cavity. The lung 1 corresponds to the "organ" of the present invention, the thoracic cavity corresponds to the "internal space" of the present invention, and the thoracoscope corresponds to the "endoscope" of the present invention.

[0036] This lesion site identification method is roughly divided into three steps. First, in the lesion site identification method, a pleural sheet 20 (see FIG. 3(d)) is created (S1). The pleural sheet 20 corresponds to the "organ covering sheet" of the present invention, and is a sheet onto which the outline of a lung lobe 3 (see FIG. 6), which is a part of the lung 1 of the patient on whom surgery is to be performed, is transferred. A specific method for creating the pleural sheet 20 in step S1 will be described later with reference to FIGS. 2 to 4. In step S1, a mark 21 (see FIG. 3(e)) is attached to the pleural sheet 20 at a position corresponding to the lesion site 2. This step S1 corresponds to the "organ covering sheet manufacturing method" of the present invention.

[0037] Next, in the lesion site identification method, the pleural sheet 20 created in step S1 is covered on the lung 1, specifically, on the lung lobe 3 whose contour has been transferred to the pleural sheet 20 (S2). A specific method for covering with the pleural sheet 20 will be described later with reference to Fig. 5(a) and Figs. 6(a) to (c), and this step S2 corresponds to the "covering step" of the present invention.

[0038] Then, in the lesion site identification method, the lesion site 2 in the lung 1 is identified from the mark 21 affixed to the pleural sheet 20 covering the lung 1 in step S2 (S3). A specific method for identifying the lesion site 2 will be described later with reference to Fig. 5(b) and Figs. 6(d)-(e), and this step S3 corresponds to the "identification step" of the present invention.

[0039] <1.2. How to prepare a pleural sheet> Next, the method for creating the pleural sheet 20 (S1 in FIG. 1) will be described in detail with reference to FIGS. 2 to 4. FIG. 2 is a flowchart showing the method for creating the pleural sheet 20 (S1). FIG. 3(a) is a diagram schematically showing 3D data 10 of a lung lobe 3. FIG. 3(b) is a diagram showing a full-scale model 15 of a lung lobe 3 created using a 3D printer (hereinafter referred to as a "lobe model"). FIG. 3(c) is a diagram showing the lobe model 15 covered with a PGA sheet 19. FIG. 3(d) is a diagram showing the pleural sheet 20 onto which the contour of the lobe model 15 has been transferred and fixed. FIG. 3(e) is a diagram showing the pleural sheet 20 with a mark 21 added at a position corresponding to the lesion site 2. FIG. 4(a) is a diagram showing the pleural sheet 20 in a folded state, and FIG. 4(b) is a diagram showing the pleural sheet 20 restored from the folded state.

[0040] As shown in Figure 2, in the method (S1) of creating a pleural sheet 20, first, 3D data 10 of a lung lobe 3 including a lesion site 2 as shown in Figure 3(a) is constructed (S11) based on DICOM (Digital Imaging and Communications in Medicine) data, which is CT imaging data obtained by a computed tomography (hereinafter referred to as "CT") scan of the lung 1 performed in advance.

[0041] This 3D data 10 also includes lesion site data 11 indicating the lesion site 2. In step S11, when the lesion site 2 exists inside the lung lobe 3 in the DICOM data, the 3D data 10 is constructed so that the position of the lesion site 2 is also indicated on the surface (shell) of the lung lobe 3. This 3D data 10 is saved in, for example, an STL (Standard Triangulated Language) format.

[0042] Next, in the method for creating a pleural sheet 20 (S1), the STL-formatted 3D data 10 constructed in step S11 is edited to be 3D printable. Then, as shown in Figures 2 and 3(b), a full-size lung lobe model 15 is created using a 3D printer (S12). Step S12 corresponds to the "organ model creation step" of the present invention, and the lung lobe model 15 corresponds to the "organ model" of the present invention.

[0043] Since lobe model 15 is created based on 3D data 10, lesion mark 16 indicating the position of lesion site 2 is formed on the outer shell of lobe model 15 not only when lesion site 2 is on the surface of lobe 3 but also when lesion site 2 is inside lobe 3. That is, lobe model 15 indicates the position corresponding to lesion site 2 on its outer shell.

[0044] The lung lobe model 15 is made of a transparent resin.

[0045] Next, in the method for producing a pleural sheet 20 (S1), as shown in FIG. 2, the lung lobe model 15 is sterilized (S13). As described above, the lung lobe model 15 is made of transparent resin, which allows for sterilization. This allows the pleural sheet 20 to be produced in a clean field using a sterilized lung lobe model 15, thereby preventing the pleural sheet 20 from being contaminated with bacteria. Therefore, even if the lung 1 is covered with the pleural sheet 20 as described below, bacterial infection of the patient can be prevented.

[0046] Next, in the method for producing the pleural sheet 20 (S1), as shown in Figures 2 and 3(c), a sterilized lung lobe model 15 is covered in a clean field with multiple 10 cm x 10 cm polyglycolic acid (PGA) sheets 19. Then, the shape of the lung lobe model 15 is transferred onto the PGA sheets 19 that have been covered on the lung lobe model 15 (S14). The number of PGA sheets 19 required to transfer the shape of the lung lobe model 15 varies depending on the size of the lung lobe model 15, but typically 2 to 4 PGA sheets 19 are used.

[0047] In the method for producing the pleural sheet 20 (S1), as shown in FIG. 2, the shape of the lung lobe model 15 transferred onto the PGA sheet 19 is fixed using fibrin glue, and the fibrin glue is dried and hardened for a predetermined period of time, thereby producing the pleural sheet 20 (S15). Steps S14 and S15 correspond to the "organ covering sheet production step" of the present invention. The fibrin glue used in step S15 corresponds to the "adhesive" of the present invention. The sheet portion of the pleural sheet 20 to which the shape of the lung lobe model 15 has been transferred and hardened in that shape with fibrin glue corresponds to the "sheet portion" of the present invention.

[0048] In this manner, the pleural sheet 20 is made from the PGA sheet 19. Fibrin glue is used to fix and solidify the shape of the lung lobe model 15 transferred to the PGA sheet 19. The pleural sheet 20 made using the PGA sheet 19 and fibrin glue can be folded as shown in FIG. 4( a) and can be unfolded from the folded state to restore its original shape as shown in FIG. 4( b). Because the pleural sheet 20 made using the PGA sheet 19 and fibrin glue is flexible, it can be inserted into the thoracic cavity in a folded state, unfolded and restored within the thoracic cavity, and used to cover the lung 1 (lung lobe 3), as described below. The flexibility of the pleural sheet 20 allows it to be easily and reliably placed over the lung 1 (lung lobe 3).

[0049] Furthermore, the pleural sheet 20, the shape of which is fixed to the lung lobe model 15 by the fibrin glue, can be easily peeled off from the lung lobe model 15, and from this point of view as well, the use of fibrin glue is effective.

[0050] Furthermore, fibrin glue has traditionally been used as an adhesive for adhering biological tissues, and PGA sheet 19 has also traditionally been used in vivo. Therefore, there is no problem even if pleural sheet 20 remains inside the body, and pleural sheet 20 can be safely used to cover lung 1 (lobe 3).

[0051] Note that, instead of the PGA sheet 19, a mesh of glycolic acid / lactic acid polyester (90 / 10) may be used to create the pleural sheet 20. In this case, the pleural sheet 20 can be made flexible, similar to the PGA sheet 19. Furthermore, because glycolic acid / lactic acid polyester mesh has traditionally been used in vivo, there is no problem even if the pleural sheet 20 remains inside the body, and the pleural sheet 20 can be safely used to cover the lung 1 (lobe 3).

[0052] In step S15, the shape of the lung lobe model 15 is transferred to the PGA sheet 19 and the shape is fixed and hardened with fibrin glue. In the method for creating a pleural sheet 20 (S1), as shown in Figure 2, a mark is then made on the pleural sheet 20 using a marker or the like at the position of the lesion mark 16 formed on the outer shell of the lung lobe model 15 (S16).

[0053] Then, in the method for producing the pleural sheet 20 (S1), the pleural sheet 20 is peeled off from the lung lobe model 15, and holes are made at the positions of the marks on the pleural sheet 20 (S17), as shown in FIG. 3(e). That is, holes are made as marks 21 on the pleural sheet 20 at positions corresponding to the lesion sites 2 of the lungs 1 (lobes 3). Steps S16 and S17 correspond to the "marking step" of the present invention.

[0054] The holes (marks 21) made in the pleural sheet 20 make it easy to identify the location of the lesion 2 in the lung 1 (lobe 3) covered by the pleural sheet 20. Furthermore, a predetermined marking 23 (see FIG. 6(e)) can be easily made on the lesion 2 in the lung 1 (lobe 3) through the holes in the pleural sheet 20. The predetermined marking 23 on the lung 1 (lobe 3) can be made, for example, with a skin pen (skin marker) or by suturing or ligating with thread.

[0055] In this manner, the method for producing the pleural sheet 20 (S1) is completed.

[0056] <1.3. Method of covering lungs with pleural sheet> Next, the method of covering the lung 1 (lobe 3) with the prepared pleural sheet 20 (S2 in FIG. 1) will be described in detail with reference to FIG. 5(a) and FIGS. 6(a) to 6(c). FIG. 5(a) is a flowchart showing the method of covering the lung 1 (lobe 3) with the pleural sheet 20 (S2). FIGS. 6(a) to 6(c) are schematic diagrams showing the method of covering the lung 1 with the pleural sheet 20 (S2). The method of covering the lung 1 with the pleural sheet 20 (S2) and the method of identifying the lesion site 2 in the lung 1 (lobe 3) using the pleural sheet 20 (S3), which will be described later, are performed immediately before the resection of the lung 1 as part of the lung resection surgery.

[0057] In the method of covering with the pleural sheet 20 (S2), as shown in Fig. 5(a), first, the lung 1 on the side to be resected is collapsed by one-lung ventilation (S21). This expands the space in the thoracic cavity on the side of the lung 1 to be resected, making it easier to cover that lung 1 (lobe 3) with the pleural sheet 20.

[0058] Next, in the method for covering the pleural sheet 20 (S2), the pleural sheet 20 is folded (S22) as shown in Fig. 6(a). Then, in the method for covering the pleural sheet 20 (S2), the folded pleural sheet 20 is inserted into the thoracic cavity through a port 30 provided in the wound opened for the purpose of thoracoscopic surgery (S23), as shown in Figs. 5(a) and 6(a).

[0059] Next, in the method for covering with the pleural sheet 20 (S2), as shown in Figures 5(a) and 6(b), the inserted pleural sheet 20 is unfolded and restored to its original shape in the thoracic cavity expanded by one-lung ventilation (S24). Then, in the method for covering with the pleural sheet 20 (S2), as shown in Figures 5(a) and 6(c), the restored pleural sheet 20 is placed over the lung 1 (lobe 3) to be resected (S25).

[0060] Then, in the covering method (S2) of the pleural sheet 20, bilateral lung ventilation is performed (S26) as shown in Fig. 5(a). This allows the pleural sheet 20, which has been placed over the collapsed lung 1 (lobe 3), to completely cover the inflated lung 1 (lobe 3) by bilateral lung ventilation.

[0061] In this manner, the covering with the pleural sheet 20 (S2) is completed.

[0062] 5(a) , the pleural sheet 20 is inserted in a folded state into the thoracic cavity through a port 30 provided in the wound, where it is restored to its original shape and covers the lung 1 (lung lobe 3). This allows the pleural sheet 20 to be inserted into the thoracic cavity through a small incision made to insert a thoracoscope into the thoracic cavity for surgical purposes, and then placed over the lung 1 (lung lobe 3).

[0063] Furthermore, in the method for covering the pleural sheet 20 (S2), the pleural sheet 20 created from the full-size lung lobe model 15 is placed over the collapsed lung 1 (lobe 3) by one-lung ventilation, allowing the pleural sheet 20 to be easily placed over the lung 1 (lobe 3). Then, in the method for covering the pleural sheet 20 (S2), the lung 1 (lobe 3) is inflated by bilateral ventilation with the pleural sheet 20 placed over it. This allows the pleural sheet 20, which is the full size of the lung 1 (lobe 3), to be reliably placed over the lung 1 (lobe 3). Therefore, as described below, the lesion site 2 in the lung 1 (lobe 3) can be accurately identified from the holes (marks 21) made in the pleural sheet 20. Therefore, the lesion site 2 in the lung 1 (lobe 3) can be accurately identified while the pleural sheet 20 is easily placed over the lung 1 (lobe 3).

[0064] <1.4. Method for identifying lung lesions using pleural sheets> Next, with reference to Fig. 5(b) and Fig. 6(d)-(e), a method for identifying a lesion site 2 in the lung 1 (lobe 3) using a pleural sheet 20 covering the lung 1 (lobe 3) (S3 in Fig. 1) will be described in detail. Fig. 5(b) is a flowchart showing the method for identifying a lesion site 2 (S3). Fig. 6(d)-(e) are diagrams schematically showing the method for identifying a lesion site 2 (S3).

[0065] First, in this method for identifying the lesion site 2 (S3), a thoracoscope is used to confirm the position of a hole (mark 21) made in the pleural sheet 20 corresponding to the position of the lesion site 2 in the lung 1 (lobe 3), and the lesion site 2 is identified in the lung 1 (lobe 3) that can be seen through the hole (mark 21) (S31). At this time, the lung 1 (lobe 3) remains inflated by bilateral lung ventilation, so the position of the lesion site 2 can be identified with high accuracy. Note that the position of the hole (mark 21) made in the pleural sheet 20 can be confirmed using a thoracoscope even when the lung 1 is inflated.

[0066] Next, in the method for identifying the lesion site 2 (S3), the lung 1 on the side to be resected is collapsed by one-lung ventilation, and then, as shown in Figure 6(d), a predetermined marking 23 (see Figure 6(e)) is made on the lung 1 (lobe 3) at the position of the lesion site 2 identified in step S31 (S32). As described above, the predetermined marking 23 is made using a skin pen (skin marker), or by suturing or ligating thread.

[0067] After the predetermined marking 23 is made on the lung 1 (lobe 3), in the method for identifying the lesion site 2 (S3), as shown in Figures 5(b) and 6(e), the pleural sheet 20 covering the lung 1 (lobe 3) is removed from the lung 1 (lobe 3) and extracted outside the body (S33).

[0068] In this way, the method (S3) for identifying the lesion site 2 in the lung 1 (lobe 3) using the pleural sheet 20 is completed.

[0069] Thus, in the method (S3) for identifying a lesion site 2, a pleural sheet 20 is created to resemble a patient's lung 1 (lobe 3), and the patient covers the pleural sheet 20 before resection during resection surgery. The pleural sheet 20 allows for easy and accurate identification of the lesion site 2 in the lung 1 (lobe 3) through holes (marks 21) made in the pleural sheet 20 at positions corresponding to the lesion site 2. Then, a predetermined marking 23 can be easily made at the position of the lesion site 2 in the lung 1 (lobe 3) identified by the holes (marks 21). Based on the predetermined markings 23, medical personnel can resect a portion of the lung 1 (lobe 3) including the lesion site 2.

[0070] <1.5. Effectiveness of the lesion site identification method according to the first embodiment> A clinical trial was conducted to demonstrate the effectiveness of the lesion site identification method according to the first embodiment. In this clinical trial, a pleural sheet 20 was created by the above-described method and covered a lung lobe 3 that had actually been removed in a lobectomy case, and the position of a predetermined marking 23 made by the pleural sheet 20 was compared with the actual position of the lesion site 2 in the removed lung lobe 3.

[0071] The pleural sheet 20 was prepared by creating a lobe model 15 of the excised lung lobe 3 based on the CT scan data taken before the excision surgery, and then creating a pleural sheet 20 with a mark 21 from the lobe model 15 using the method shown in Figure 2.

[0072] Figure 7(a) shows the creation of a pleural sheet 20 using a created lung lobe model 15 of lung lobe 3. The lung lobe model 15 was made of transparent resin. The pleural sheet 20 was created by covering the lung lobe model 15 with four 10 cm x 10 cm PGA sheets 19, transferring the shape of the lung lobe model 15 to the PGA sheets 19, and then fixing and hardening the transferred shape with 10 ml of fibrin glue. As shown in Figure 7(a), a mark 21 indicating the position of the lesion site 2 is attached to the pleural sheet 20.

[0073] FIG. 7(b) shows a state in which a predetermined marking 23 (in the example shown in FIG. 7(b) , a suture or ligation) has been made on a lung lobe 3 via a mark 21 on a pleural sheet 20. FIG. 7(c) is a diagram comparing the position of the predetermined marking 23 made using a pleural sheet 20 with the position of the lesion site 2 in an excised lung lobe 3. FIG. 7(d) is a diagram comparing the position of the predetermined marking 23 made using a pleural sheet 20 made on another excised lung lobe 3 by a similar method with the actual position of the center of the lesion site 2 in the excised lung lobe 3.

[0074] In the results of a clinical trial shown in Figure 7(c), the position where the predetermined marking 23 was made was compared with the actual position of the center of the lesion site 2 of the excised lung lobe 3, and it was found to be approximately 20 mm. In addition, in the results of another clinical trial shown in Figure 7(d), the position where the predetermined marking 23 was made was compared with the actual position of the center of the lesion site 2 of the excised lung lobe 3, and it was found to be approximately 14 mm.

[0075] The results of this clinical trial showed that the position of the lesion 2 identified using the pleural sheet 20 (the position of the predetermined marking 23) captured part of the actual lesion 2 in the lung lobe 3, and was included within the area where the lung lobe 3 was to be resected. Therefore, it was confirmed that the lesion identification method according to the first embodiment is effective.

[0076] <1.6. Comparison of the lesion site identification method according to the first embodiment with other lesion site identification methods> Table 1 compares the superiority of the lesion site identification method according to the first embodiment (hereinafter referred to as the "pleural sheet method") with other lesion site identification methods, including CT-guided dye marking, the VAL-MAP method, and RFID tag placement, in terms of radiation exposure, the time required from marking the lesion site 2 in the lung 1 to resecting the lesion site 2, the pain it causes to the patient, the possibility of complications, the impact of the background lung, the ease of marking the lesion site 2 in the lung 1, and the impact of residual tissue. In Table 1, "◯" indicates superiority over other methods, "×" indicates lack of superiority over other methods, and "△" indicates that there may be cases where the method lacks superiority over other methods.

[0077] [Table 1] First, let us consider radiation exposure. In CT-guided dye marking, the lesion site 2 is identified under CT fluoroscopy, so radiation exposure is a problem for both patients and medical personnel. Furthermore, in the VAL-MAP method and RFID tag placement, the lesion site 2 is identified using a bronchoscope in conjunction with X-ray fluoroscopy, so radiation exposure is a problem for both patients and medical personnel. On the other hand, while the pleural sheet method requires CT scan data to create a lung lobe model 15, CT scans are not required solely for this purpose; data from CT scans performed as part of preoperative examinations can be used. Therefore, radiation exposure is not a problem with the pleural sheet method, making it superior to other methods.

[0078] Next, we will explain the time required from marking lesion 2 on lung 1 to its resection. In CT-guided dye marking and VAL-MAP, lesion 2 on lung 1 is marked, followed by general anesthesia, and then a port is inserted into the thoracotomy incision to resect lesion 2. This requires approximately one hour from marking to resection. Therefore, the dye injected during marking is absorbed or diffused into the body before resection of lesion 2, making it difficult to identify lesion 2. Similarly, in RFID tag placement, an RFID tag is placed on lesion 2 on lung 1, followed by general anesthesia, and then a port is inserted into the thoracotomy incision. However, the RFID tag must be searched for before resection of lesion 2. Therefore, RFID tag placement requires additional time from marking to resection, and there is a problem that the placed RFID tag may move from the position of lesion 2 during this time. In contrast, in the pleural sheet method, the lung 1 (lobe 3) is covered with a pleural sheet 20 during resection surgery, the lesion site 2 is identified, and then the lesion site 2 is immediately resected. Therefore, the pleural sheet method is superior to other methods because it allows the identified lesion site 2 to be resected reliably without losing sight of it.

[0079] Next, we will explain the pain inflicted on the patient. CT-guided dye marking requires approximately 20 to 30 minutes before surgery to mark the lesion site 2, which causes psychological pain to the patient. There are also other issues, such as pain from the puncture for local anesthesia and dye injection, and pain from holding one's breath during the puncture for dye injection. The VAL-MAP method and RFID tag placement also cause pain to the patient when inserting a bronchoscope. On the other hand, the pleural sheet method involves covering the lung 1 (lobe 3) with a pre-prepared pleural sheet 20 during surgery, which causes almost no pain to the patient. Therefore, the pleural sheet method has advantages over other methods.

[0080] Next, we will discuss potential complications. CT-guided dye marking and the VAL-MAP method carry the risk of complications such as pneumothorax, bleeding, and air embolism due to the puncture caused by dye injection. The risk of these complications increases the more frequently dye injections are performed. RFID tag placement also carries the risk of complications similar to those associated with CT-guided dye marking. In contrast, the pleural sheet method simply involves covering the lung 1 (lobe 3) with a pleural sheet 20 created in a clean field. Furthermore, the designated markings 23 are made using methods traditionally used in vivo, such as skin pens (skin markers) or suturing and ligation. Therefore, there is no risk of complications, making it superior to other methods.

[0081] Next, we will explain the influence of the background lung. With CT-guided dye marking and the VAL-MAP method, the dye that diffuses after injection can become difficult to see, coupled with discoloration of the background lung, making it difficult to identify the lesion site 2. In contrast, with RFID tags, the lesion site 2 is identified by detecting the signal emitted from the RFID tag, so there is no influence from the background lung. Furthermore, with the pleural sheet method, the lesion site 2 can be identified by the hole (mark 21) made by the pleural sheet 20, so there is no influence from the background lung. Therefore, the pleural sheet method and RFID placement have advantages over other methods.

[0082] Next, we will explain the ease of marking the lesion site 2. CT-guided dye marking involves marking the lung 1 through the chest wall, which is affected by the ribs, scapula, arteries, and veins of the chest wall, making marking around the lesion site 2 difficult. The VAL-MAP method and RFID tag placement require the identification of the lesion site 2 using a bronchoscope, and RFID tag placement also requires the placement of an RFID tag, making marking difficult. On the other hand, the pleural sheet method identifies the lesion site 2 using holes (marks 21) made in the pleural sheet 20, making it easy to mark the lesion site 2 without being affected by the chest wall. Therefore, the pleural sheet method has advantages over other methods.

[0083] Next, we will explain the impact of residual materials. With CT-guided dye marking and the VAL-MAP method, there is a possibility that the needle used to inject the dye may become dislodged and remain inside the body, which could cause damage to organs and other organs, creating a problem. With RFID tag placement, there is a risk that the placed RFID tag may become dislodged and remain inside the body. On the other hand, the pleural sheet method uses materials that have traditionally been used in vivo, such as PGA sheet19 (or glycolic acid / lactic acid polyester mesh) and fibrin glue, so there are no problems even if the tag remains inside the body. Therefore, the pleural sheet method has advantages over other methods.

[0084] <1.7. Summary of the First Embodiment> As described above, according to the lesion site identification method of the first embodiment, in step S12 (see FIG. 2) of the method (S1) for creating a pleural sheet 20, a full-size lobe model 15 of the lobe 3, which is a part of the lung 1 including the lesion site 2, is created by a 3D printer based on data obtained by CT imaging of the lung 1 (lobe 3). The outer shell of this lobe model 15 indicates a position corresponding to the lesion site 2.

[0085] Next, in step S14 (see FIG. 2 ) of the method (S1) for producing a pleural sheet 20, the lung lobe model 15 is covered with a PGA sheet 19 (or glycolic acid / lactic acid polyester mesh), and the shape of the lung lobe model 15 is transferred to the PGA sheet 19. Then, in step S15 (see FIG. 2 ) of the method (S1) for producing a pleural sheet 20, the shape of the lung lobe model 15 transferred to the PGA sheet 19 is fixed using fibrin glue, and the fibrin glue is dried and hardened for a predetermined period of time, thereby producing a pleural sheet 20. Thereafter, in steps S16 and S17 (see FIG. 2 ) of the method (S1) for producing a pleural sheet 20, a mark 21 is made in the produced pleural sheet 20 by making a hole at a position corresponding to the lesion site 2 of the lung 1 (lobe 3).

[0086] Next, in a method for covering the pleural sheet 20 (S2), the pleural sheet 20 with the mark 21 is covered on the lung 1 (lung lobe 3). Then, in a method for identifying the lesion site 2 using the pleural sheet 20 covering the lung 1 (lung lobe 3) (S3), the lesion site 2 is identified based on the mark 21 on the pleural sheet 20.

[0087] In this way, the pleural sheet 20 is created from the lung lobe model 15 that mimics the lung 1 (lobe 3) of each patient, and the lung 1 (lobe 3) is covered with the pleural sheet 20 to identify the lesion site 2, thereby enabling easy and accurate identification of the lesion site 2. Furthermore, the lesion site 2 can be identified without the need for CT fluoroscopy or X-ray fluoroscopy at the stage of marking the lesion site 2, the need to use a bronchoscope, or the need to puncture the lesion site 2 with a needle to inject a dye or to place an RFID tag. Therefore, radiation exposure and pain to the patient can be reduced, and the lesion site 2 in an organ can be identified safely.

[0088] Other effects and advantages of the lesion site identification method according to the first embodiment are as described above.

[0089] <2. Second embodiment> Next, a lesion site identification method according to a second embodiment of the present invention will be described, focusing on differences from the lesion site identification method according to the first embodiment, with reference to Figure 8. In the following description, the same components as those in the lesion site identification method according to the first embodiment will be denoted by the same reference numerals, and their description will be omitted or simplified.

[0090] Fig. 8(a) is a diagram showing a mark 21 applied to a pleural sheet 20 at a position corresponding to a lesion site 2 and a mark 25 applied to a position corresponding to a boundary line between regions of a lung lobe 3. Fig. 8(b) is a diagram showing an ideal resection line 26 of a lung lobe 3 designed for the pleural sheet 20 shown in Fig. 8(a).

[0091] In the lesion site identification method according to the second embodiment, steps S11, S12, S16 and S17 are changed from the method for creating the pleural sheet 20 (S1, see FIG. 2) in the lesion site identification method according to the first embodiment.

[0092] First, in step S11, when constructing 3D data 10 of a lung lobe 3 including a lesion site 2, the 3D data 10 is constructed not only so that the position of the lesion site 2 is indicated on the surface (shell) of the lung lobe 3, but also so that the boundaries between sections of the lung lobe 3 are indicated on the surface (shell) of the lung lobe 3. The boundaries between sections of the lung lobe 3 are not normally visible to the naked eye, but can be identified by determining the course of the bronchi and / or blood vessels from CT scan data.

[0093] Next, in step S12, a full-size lung lobe model 15 is created using a 3D printer based on the 3D data 10 constructed in step S11. As a result, not only lesion marks 16 indicating the positions of lesion sites 2 but also boundary lines indicating the boundaries between sections of lung lobe 3 are formed on the outer shell of lung lobe model 15. In other words, lung lobe model 15 also represents the boundaries between sections of lung 1 (lobe 3).

[0094] Next, in steps S16 and S17, not only are marks 21 made (holes drilled) on the pleural sheet 20 at the positions of the lesion marks 16 formed on the outer shell of the lung lobe model 15, but marks 25 are also made on the positions of the boundary lines between the areas of the lung lobes 3 formed on the outer shell of the lung lobe model 15.

[0095] 8(a), on the pleural sheet 20, a position corresponding to the lesion site 2 is indicated by a mark 21, and a position corresponding to the boundary line between the regions of the lung lobe 3 is indicated by a mark 25. Therefore, a medical professional can identify the boundary line between the regions of the lung 1 (lobe 3) that is difficult to distinguish with the naked eye by the mark 25 from the pleural sheet 20 covering the lung 1 (lobe 3).

[0096] Here, in segmental resection of lung 1, lung 1 is resected at the boundary between the segments. On the other hand, in resection of lesion 2, an appropriate distance (resection margin) must be provided between lesion 2 and the resection position to prevent lesion 2 from being completely removed and remaining in lung 1. Before surgery, medical professionals can determine the distance between the location of lesion 2 and the boundary position between the segments from marks 21 and 25 affixed to pleural sheet 20. If the resection margin between the location of lesion 2 and the boundary position between the segments is insufficient, medical professionals can design resection line 26 in advance on pleural sheet 20 to ensure the distance (margin) between lesion 2 and the resection position of lung 1, as shown in Figure 8(b).

[0097] By covering the lung 1 (lobe 3) with the pleural sheet 20 marked with this ideal resection line 26, the medical professional can resect a part of the lung 1 according to the resection line 26 marked on the pleural sheet 20. Therefore, a margin is secured from the position of the lesion 2, and a part of the lung 1 including the lesion 2 is resected, so that the lesion 2 can be resected reliably.

[0098] <Modification> Although the present invention has been described above based on the embodiments, it is readily apparent that the present invention is not limited to the above embodiments and that various improvements and modifications are possible within the scope of the present invention. For example, each embodiment may be modified by adding or replacing a part or parts of the configuration of another embodiment, including the modifications described below. Furthermore, the numerical values ​​given in the above embodiments are merely examples, and other numerical values ​​may of course be adopted.

[0099] In the above embodiments, in step S33 of the method (S3) for identifying the lesion site 2 in the lung 1 (lobe 3) using the pleural sheet 20 covering the lung 1 (lobe 3) shown in Figure 5(b), the pleural sheet 20 covering the lung 1 (lobe 3) is removed from the lung 1 (lobe 3) and extracted outside the body. However, the resection surgery for the lesion site 2 may be performed while the pleural sheet 20 remains covering the lung 1 (lobe 3). As described above, the pleural sheet 20 is made of a material that can be used in vivo, and therefore, there is no problem even if it is left behind.

[0100] In each of the above embodiments, a hole is made in the pleural sheet 20 as a mark 21 at a position corresponding to the lesion site 2, but this is not necessarily limited to this, and some kind of mark, such as a mark made with a specified pen, may also be used.

[0101] In the above embodiments, the lung 1 has been described as an example of an organ having a lesion site 2, but the organ is not necessarily limited to the lung 1 and may be another organ, such as the liver. That is, in the case of the liver, the present invention is applicable as a lesion site identification method for identifying the lesion site 2 in the liver when performing surgery to resect a portion of the liver by inserting a laparoscope, which is an endoscope, into the abdominal cavity, which is a space inside the body. [Explanation of symbols]

[0102] 1 lungs 2. Lesion site 3 lung lobes 10 3D data 11 Lesion location data 15 Lung Lobe Model 16 Lesion Mark 19 PGA seats 20 Pleural Sheet 21 marks 23 Prescribed markings 25 marks 26 Separation line 30 ports

Claims

1. 1. A method for identifying a lesion site in an organ when performing surgery to remove a part of the organ by inserting an endoscope into a space inside the body, comprising: an organ model creation step of creating, using a 3D printer, a full-size organ model of at least a part of the organ including the lesion site, based on data obtained by computed tomography of the organ, the organ model having an outer shell showing a position corresponding to the lesion site; an organ covering sheet preparation step of covering the organ model with a sheet, transferring the shape of the organ model to the sheet, and fixing the sheet with an adhesive; a marking step of marking the organ covering sheet at a position corresponding to the lesion site of the organ; a covering step of covering the organ with the organ covering sheet having the mark; and identifying the lesion site based on the mark on the organ covering sheet covering the organ.

2. 2. The method for identifying a lesion site according to claim 1, wherein the covering step includes inserting the organ covering sheet with the marking in a folded state into the body through a port provided in the wound, and then restoring the organ covering sheet inside the body to cover the organ.

3. the marking step comprises drilling holes in the organ covering sheet at positions corresponding to the lesions of the organs, as the marks; 2. The method for identifying a lesion site according to claim 1, wherein the identification step identifies the lesion site by making a predetermined marking on the organ visible through the hole in the organ covering sheet covering the organ.

4. 2. The method for identifying a lesion site according to claim 1, wherein the adhesive is fibrin glue.

5. 2. The method for identifying a lesion site according to claim 1, wherein the sheet is a polyglycolic acid sheet or a glycolic acid / lactic acid polyester mesh.

6. 2. The method for identifying a lesion site according to claim 1, wherein the organ model creation step creates the organ model using the 3D printer with a transparent resin as a material.

7. the organ is a lung, the organ model creation step includes creating a full-size organ model of a lung lobe including the lesion site; 7. The method for identifying a lesion site according to claim 1, wherein the covering step includes covering a collapsed lung by one-lung ventilation with the organ covering sheet bearing the mark, and then inflating the lung by two-lung ventilation.

8. the organ model creation step represents boundaries between lung segments in the organ model based on data obtained by the computed tomography; 8. The method for identifying a lesion site according to claim 7, wherein the marking step further includes applying marks to the organ covering sheet at positions corresponding to the borders between the lung sections.

9. a sheet portion onto which the shape of at least a part of an organ including a lesion site is transferred; a mark attached to the sheet portion at a position corresponding to the lesion site, An organ covering sheet, characterized in that by covering the organ with the sheet portion, the lesion site can be identified from the position of the mark.

10. 10. The organ covering sheet according to claim 9, wherein the sheet portion is configured so as to be able to restore the shape of at least a part of the transferred organ from a folded state.

11. A method for producing an organ covering sheet that covers an organ including a lesion site to identify the lesion site of the organ, comprising: an organ model creation step of creating, using a 3D printer, a full-size organ model of at least a part of the organ including the lesion site, based on data obtained by computed tomography of the organ, the organ model having an outer shell showing a position corresponding to the lesion site; an organ covering sheet preparation step of covering the organ model with a sheet, transferring the shape of the organ model to the sheet, and fixing the sheet with an adhesive; a marking step of marking the organ covering sheet at a position corresponding to a lesion site of the organ.

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