Custom-made implant and method for manufacturing the same

Abstract

To provide a method for manufacturing a custom-made implant that enables cartilage to be molded into a desired shape without bending and allows significant reduction in a surgical time.SOLUTION: A method for manufacturing a custom-made implant using cartilage harvested from a human body at least includes: a step S1 of harvesting cartilage from the human body; a step S2 of pulverizing the cartilage; a step S3 of mixing artificial dermis with the pulverized cartilage to form a paste; a step S4 of pouring the paste of the cartilage and the artificial dermis into a mold and solidifying them; a step S5 of molding a sheet in a lattice or mesh form from a bioabsorbable material; a step S6 of removing from the mold the implant body solidified in the mold and applying a bioadhesive to the implant body; and a step S7 of heating the sheet and, in a flexible state, covering the implant body, to which the bioadhesive has been applied, with the sheet.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a custom-made implant molded from cartilage harvested from the human body and a method for producing the same. [Background technology]

[0002] In the fields of cosmetic surgery and orthopedics, bioimplantable implants are prescribed as medical devices under the Pharmaceutical Affairs Law with a certain width, length, thickness, etc., and are widely used in clinical practice as ready-made products whose mechanical and biological safety has been confirmed. However, there are individual differences in the bone structure and bone shape of each patient, and ready-made implants may not be suitable for each patient depending on their individual bone structure and symptoms, so "custom-made implants" with individual adaptability are required. The clinical application of custom-made implants is said to be beneficial for patients and medical professionals, as it enables excellent fixation and functional reconstruction, improves surgical outcomes, realizes minimally invasive surgery, reduces reoperations, realizes early rehabilitation, and allows early social reintegration.

[0003] Patent Document 1 discloses a method for manufacturing a 3D custom-made implant, which includes an embodiment step of dividing a CT image of a patient's body using a threshold based on the brightness value of the image of the body and then embodying a 3D object of the body, a design step of designing a designed implant based on the 3D object embodied in the embodiment step, a guideline implant manufacturing step of manufacturing the designed implant using a guideline, and a manufacturing step of manufacturing a custom-made implant of the same shape as the guideline implant using a material containing silicon, and the guideline implant manufacturing step is manufactured using a 3D printer.

[0004] Patent Document 2 discloses a cartilage tissue for transplantation. This technology is a transplantable osteochondral implant, which comprises cultured cartilage tissue attached to a biocompatible scaffold, the cartilage tissue comprises chondrocytes having a matrix (CM), the CM is obtained by culturing chondrogenic cells in a test tube and resembles a cell membrane found in a living body, and the scaffold comprises a large number of micropores and is selected from the group comprising at least one of natural cancellous bone, demineralized natural cancellous bone, collagen, and a bone substitute material. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2019-217266 A [Patent Document 2] International Publication No. WO2003 / 094703 Summary of the Invention [Problem to be solved by the invention]

[0006] Conventional custom-made implants use a so-called analog method, in which cartilage taken from the human body is processed, shaped, and inserted into the nose after understanding the patient's needs. However, because cartilage is not a material that can be finely processed, there are many steps involved, and the surgery takes a long time. In particular, when inserting a custom-made implant into the nose, it is important to shape it so that it does not shift or sink, but this is difficult to do with analog suturing.

[0007] In addition, during surgery, the nose is sometimes opened to insert ear or rib cartilage, but when using long pieces of cartilage, the cartilage can become curved, which is a problem because it is difficult to obtain straight cartilage from the human body.

[0008] There is also a method of using artificial materials as custom-made implants. For example, polydeoxanone (PDO) or osteopor (PCL) can be kneaded into the shape of cartilage. However, because it is a completely artificial material, there are problems such as inflammation of the skin and the nose returning to its original shape when it dissolves.

[0009] The present invention has been made in consideration of the above circumstances, and aims to provide a custom-made implant that can mold cartilage into a desired shape, does not bend, and can significantly shorten surgery time, as well as a method for manufacturing the same. [Means for solving the problem]

[0010] (1) In order to achieve the above object, the present application takes the following measures. That is, the custom-made implant of the present invention is a custom-made implant molded from cartilage harvested from a human body, and is characterized by comprising an implant body molded from a mixture of the pulverized cartilage and artificial dermis, a bioadhesive applied to the implant body, and a mesh-like sheet that is molded from a material absorbable in the body and that becomes flexible when heated, and that covers the implant body to which the bioadhesive is applied.

[0011] (2) Furthermore, the method for producing a custom-made implant of the present invention is a method for producing a custom-made implant using cartilage harvested from a human body, and is characterized by including at least the steps of harvesting cartilage from a human body, crushing the cartilage, mixing the crushed cartilage with artificial dermis to form a paste, pouring the pasty cartilage and artificial dermis into a formwork and allowing it to harden, molding a lattice- or mesh-shaped sheet using a material that is absorbed in the body, removing the implant body that has hardened in the formwork from the formwork and applying a bioadhesive to the implant body, and heating the sheet and, while the sheet is in a flexible state, covering the implant body to which the bioadhesive has been applied with the sheet.

[0012] (3) Furthermore, the method for producing a custom-made implant of the present invention is a method for producing a custom-made implant using cartilage harvested from a human body, and is characterized by including at least the steps of harvesting cartilage from a human body, crushing the cartilage, mixing the crushed cartilage with artificial dermis to form a paste, pouring the pasty cartilage and artificial dermis into a formwork and allowing it to harden, molding a lattice- or mesh-shaped sheet using a material absorbable in the body, removing the implant body that has hardened in the formwork from the formwork and applying a bioadhesive to the implant body, covering the implant body to which the bioadhesive has been applied with the sheet, and heating the sheet. Effect of the Invention

[0013] According to the present invention, fine adjustments in 1mm increments are possible during molding, enabling highly accurate molding of implants. As a result, the implant will not shift or sink when inserted into the nose. Furthermore, surgery time can be significantly reduced. [Brief description of the drawings]

[0014] [Figure 1] 1 is a flow chart showing a method for manufacturing a custom-made implant according to the present invention. [Diagram 2] 1 is an external view of a custom-made implant manufactured by the manufacturing method of the present invention. [Diagram 3] 1 is an external view of a custom-made implant manufactured by the manufacturing method of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The inventor discovered that when performing surgery to insert an implant into the human body, ear cartilage can be harvested, crushed, turned into a paste, molded, and hardened, allowing it to flexibly conform to the desired shape, and thus arrived at the present invention.

[0016] That is, the method for producing a custom-made implant of the present invention is a method for producing a custom-made implant using cartilage harvested from a human body, and is characterized by including at least the steps of harvesting cartilage from a human body, crushing the cartilage, mixing the crushed cartilage with artificial dermis to form a paste, pouring the paste-like cartilage and artificial dermis into a mold and solidifying it, molding a lattice- or mesh-shaped sheet with a material absorbable in the body, removing the implant body solidified in the mold from the mold and applying a bioadhesive to the implant body, and heating the sheet and covering the implant body coated with the bioadhesive with the sheet in a flexible state. This allows fine adjustment in 1 mm units during molding of the implant, enabling molding of a highly accurate implant. As a result, the implant does not shift or sink when inserted into the nose, making it possible to significantly shorten the operation time. Hereinafter, an embodiment of the present invention will be specifically described with reference to the drawings.

[0017] [Manufacturing method for custom-made implants] The tools used to illustrate the method of manufacturing a custom-made implant according to the present invention are a mortar, a mold (cast form), preserved cartilage, Volfeel (bioadhesive), a silicone form, human ear cartilage, polydeoxanone (PDO) or osteopor (PCL).

[0018] FIG. 1 is a flow chart showing a method for manufacturing a custom-made implant according to the present invention. Cartilage is harvested from the human body (step S1). Cartilage that can be harvested from the human body includes auricular cartilage, costal cartilage, and nasal septum cartilage. Next, the harvested cartilage is crushed using a scalpel or the like (step S2). Next, powdered artificial dermis is dissolved in water and mixed with the crushed cartilage (step S3). The artificial dermis that can be used is one that is certified by the Ministry of Health, Labor and Welfare and is covered by insurance. For example, JPMED artificial dermis provided by Xitec Co., Ltd. can be used. Next, the implant body is molded by filling it into a mold made by, for example, a 3D printer (step S4). In this process, the crushed cartilage can be solidified into a semi-solid material like gelatin.

[0019] Next, a lattice- or mesh-shaped sheet is formed from a bioabsorbable material (step S5). Polydeoxanone (PDO) or osteopor (PCL) can be used as the bioabsorbable material, but the present invention is not limited to these. Next, a bioadhesive is applied to the implant body (step S6). Bolheal can be used here. Bolheal is sometimes used for hemostasis in surgical procedures, but the present invention is not limited to this.

[0020] Next, the lattice- or mesh-shaped sheet is heated to cover the implant body in a flexible state (step S7). If the implant body is left in a molded form, it will be as hard as an earlobe, and the shape will be unstable, difficult to grasp, and there is a risk of it collapsing. Therefore, the present inventor has devised the idea of ​​coating the implant body with a lattice- or mesh-shaped sheet. The present inventor selected polydeoxanone (PDO) or osteopor (PCL) to maintain the shape of the implant body, which can be placed in the body. These are used for sutures and face lift-ups. In particular, osteopor (PCL) has a melting point of about 60°C, so it can be processed at a lower temperature with less load than polydeoxanone (PDO), which has a melting point of 110°C to 120°C. The lattice- or mesh-shaped sheet can be prepared by cutting the sutures, arranging them in a lattice pattern, and heating them, or by cutting a sheet-shaped POD into strips and heating them. When the implant body is covered with the sheet in a flexible state by heating it, the shape of the implant body is maintained. Alternatively, the implant body may be heated in the state in which it is desired to cover it with the sheet. This melts the mesh sheet, and then it cools and hardens, so that the shape of the implant body is maintained.

[0021] [Custom-made implants] 2 and 3 are external views of a custom-made implant manufactured by the manufacturing method according to the present invention. In this embodiment, the weight ratio of cartilage to PDO or PCL, Bolheal is approximately "0.8:0.1:0.1" when the total is 1. In FIG. 2, the custom-made implant 1 is composed of an implant body 3 molded with crushed cartilage and artificial dermis, and a sheet 5 covering the implant body 3. In FIG. 3, the custom-made implant 10 is composed of an implant body 3 molded with crushed cartilage and artificial dermis, and a sheet 7 covering the implant body 3. In FIG. 3, a mesh-like sheet is formed that is finer than a lattice-like sheet. For example, in FIG. 3, the mesh is 0.1 mm square. By forming the sheet into a fine mesh shape, the tissue fluid circulates, and the effect of a good adhesion rate to the skin is obtained. A mesh-like shape has a higher adhesion rate than a lattice-like shape.

[0022] In this embodiment, a custom-made implant formed in a shape according to the patient's preference is inserted into the tip of the nose. In other words, it is inserted between the nasal skin and the nasal cartilage. According to the present invention, the number of steps is reduced, so it is possible to complete the surgery in one-fourth or one-fifth of the time required in the past. Furthermore, according to the present invention, the shape of the implant body can be fine-tuned in 1 mm increments, and precise molding can be achieved, making it possible to accurately meet the needs of patients.

[0023] A 3D printer can be used to create the mold. For example, a photo of the patient's face is taken, the height of the nose is measured, and a mold that matches the patient's needs is selected. A mold can be created each time, or a mold can be selected from pre-made molds.

[0024] Furthermore, regardless of whether it is cosmetic medicine or not, the present invention can be used to reshape a nose even if the nose shape is damaged by an accident. In addition, in facial surgery using cartilage, the shape of the ears, chin, and facial contours can also be reshaped. Here, cartilage is a tissue with no blood flow, and only water is sufficient. In skin and organs, blood vessels are formed in the cells, and the skin and organs do not function unless blood is recirculated, but cartilage is a material that can maintain its shape with tissue (tissue fluid, water) that does not require blood flow, so it can be used anywhere. For example, it can be applied to reshape the face or body, so it is suitable for cases where a finger is missing and you want to create a finger with autologous tissue.

[0025] [Effects of this embodiment] In the past, the idea of ​​packing cartilage into a mold had been around, but there were many problems with it, such as it not adhering well, taking too much time, and chemical reactions occurring. This embodiment makes it possible to solve the problems of the past by using a good combination of materials. That is, it is characterized by using the following three materials. (1) Artificial dermis (certified by the Ministry of Health, Labor and Welfare, and eligible for insurance), (2) Bolheal (biological adhesive, used in surgery to stop bleeding, etc.), (3) Polydeoxanone (PDO) and Osteopol (PCL) For example, it was found that when polydeoxanone (PDO) or osteopor (PCL) is melted into a liquid state and dripped onto the implant body, it immediately solidifies and molding does not work well. In addition, the method of passing the implant body through polydeoxanone (PDO) or osteopor (PCL) that has been heated and melted in a container of a certain size is not cost-effective because it does not stay in place too well. In addition, the method of attaching plate-shaped polydeoxanone (PDO) or osteopor (PCL) to the implant body worked well, but since cartilage is a body through which tissue fluids of the body circulate, there was a concern that if it was sealed, the tissue fluids necessary for the cartilage would not circulate and the cartilage would dry out and disappear. After such consideration, the present inventor found that it was necessary to provide an environment in which cartilage could survive, and molded it into a mesh or lattice shape. In addition, there is also the advantage that a small amount is required when the cartilage is lattice or mesh.

[0026] According to this embodiment, fine adjustments in 1 mm increments are possible during molding, enabling highly accurate molding of the implant. As a result, the implant will not shift or sink when inserted into the nose. Furthermore, surgery time can be significantly reduced. [Explanation of symbols]

[0027] 1. Custom-made implants 3 Implant body 5 Sheets 7 Sheets 10 Custom-made implants

Claims

1. A custom-made implant made from cartilage harvested from the human body, an implant body formed by mixing the crushed cartilage and artificial dermis; A bioadhesive applied to the implant body; A custom-made implant comprising: a mesh-like sheet that is molded from a material that is absorbed in the body and that becomes flexible when heated, and that covers the implant body to which the bioadhesive is applied.

2. A method for manufacturing a custom-made implant using cartilage harvested from a human body, comprising: harvesting cartilage from a human body; grinding the cartilage; mixing the crushed cartilage with an artificial dermis to form a paste; pouring the paste-like cartilage and artificial dermis into a mold and solidifying it; A step of forming a lattice- or mesh-shaped sheet from a material that is absorbed in the body; removing the implant body solidified in the mold from the mold and applying a bioadhesive to the implant body; A method for manufacturing a custom-made implant, comprising at least a step of heating the sheet and, while the sheet is in a flexible state, covering the implant body to which the bioadhesive has been applied with the sheet.

3. A method for manufacturing a custom-made implant using cartilage harvested from a human body, comprising: harvesting cartilage from a human body; grinding the cartilage; mixing the crushed cartilage with an artificial dermis to form a paste; pouring the paste-like cartilage and artificial dermis into a mold and solidifying it; A step of forming a lattice- or mesh-shaped sheet from a material that is absorbed in the body; removing the implant body solidified in the mold from the mold and applying a bioadhesive to the implant body; covering the implant body to which the bioadhesive has been applied with the sheet; and heating the sheet.

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