Medical device and method for manufacturing same

Abstract

Provided is a medical device (1) in which thrombus does not easily occur even if blood circulates. The medical device (1) has a plurality of blood flow path layers (3) each having a plate-shaped main body section (5), a groove (9) for forming a blood flow path (7), and a resin layer (11) formed on a side wall of the groove (9). The manufacturing method includes: a resin application step of applying a resin to a groove (9) of a plate-shaped main body part (5) having the groove (9) for forming a blood flow path (7); a bonding step for bonding the plate-shaped body section (5), the first film (41), and the second film (43) by sandwiching the plate-shaped body section (5) between the first film (41) and the second film (43); and a post-curing step in which, after the bonding step, the resin applied to the groove (9) in the resin application step is cured.

Description

Technical Field

[0001] The present invention relates to a medical device and a method for manufacturing the same. More specifically, the present invention relates to a medical device in which a wall surface of a blood flow path is coated with a resin and a method for manufacturing the same. Background Art

[0002] A microfluidic chip is described in Japanese Patent Publication No. 2020-134150. A blood filtration device is described in Japanese Patent Publication No. 2017-158814. A plasma separation device is described in Japanese Patent Publication No. 2020-22524. The cross-sectional area of ​​these flow paths is rectangular. Therefore, blood is prone to thrombosis when flowing through the flow paths. Moreover, these flow paths are basically obtained by processing metal. Therefore, these flow paths sometimes produce uneven processing when processing metal, or have low affinity with blood.

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Application Publication No. 2020-134150

[0006] Patent Document 2: Japanese Patent Application Publication No. 2017-158814

[0007] Patent Document 3: Japanese Patent Application Publication No. 2020-22524 Summary of the invention

[0008] Technical issues that the invention aims to solve

[0009] The object of the present invention is to provide a medical device and a method for manufacturing the same which is less likely to cause thrombosis even when blood is circulating.

[0010] Technical solutions to problems

[0011] The above-mentioned problems can be basically solved by coating the side walls of the grooves formed in the substrate with resin to round the corners and reduce the obstruction of blood circulation.

[0012] The first invention relates to a medical device. This medical device 1 has a blood flow path layer 3. The blood flow path layer 3 is usually multi-layered. The blood flow path layer 3 is a layer having a flow path for blood circulation. Moreover, each blood flow path layer 3 has a plate-shaped main body 5, a groove 9 and a resin layer 11. The resin layer 11 is an element formed on the side wall of the groove 9 by resin.

[0013] The next invention relates to a method for manufacturing a medical device, which includes a resin coating step (S101), a bonding step (S103) and a post-hardening step (S104).

[0014] Effects of the Invention

[0015] According to the present invention, a medical device and a method for manufacturing the same can be provided in which blood clots are less likely to form even when blood is circulating. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] [ Figure 1 ] Figure 1 This is a conceptual diagram showing an example of a medical device having a blood flow path layer. Figure 1 (a) shows an example of the appearance of the device. Figure 1 (b) shows an example of a blood flow path layer. Figure 1 (c) is an example showing a blood flow path.

[0017] [ Figure 2 ] Figure 2 This is a conceptual diagram for explaining a resin layer.

[0018] [ Figure 3 ] Figure 3 This is a conceptual diagram for explaining the layer structure of a blood filter device and a blood separation device.

[0019] [ Figure 4 ] Figure 4 A conceptual diagram used to illustrate the manufacturing stages of a medical device. Figure 4 (a) is a diagram showing an example of a cross section of a plate-like main body having a groove. Figure 4 (b) is a conceptual diagram showing a state where resin has been applied to the groove. Figure 4 (c) is a diagram for explaining an example of a preliminary hardening step. Figure 4 (d) is a conceptual diagram showing a state where the plate-like main body is sandwiched between the first film and the second film. Figure 4 (e) is a conceptual diagram showing a state where the object in which the plate-like main body obtained in the bonding step is sandwiched between the first film and the second film is irradiated with light to cure the resin applied to the groove. Figure 4 (f) is a conceptual diagram showing a partial view of the obtained medical device.

[0020] [ Figure 5 ] Figure 5 A photograph of the attached drawing showing the replacement of the tank portion. Figure 5 (a) is a photograph replacing the drawing of the groove portion obtained according to the example. Figure 5 (b) is a photograph of a drawing replacing a groove portion where no resin layer is provided.

[0021] [ Figure 6 ] Figure 6 The following are photographs replacing drawings showing the appearance of medical devices obtained according to Examples.

[0022] [ Figure 7 ] Figure 7This is a photograph replacing a drawing showing the use of a medical device to filter blood. Figure 7 (a) is a photograph replacing a drawing showing a state where the blood flow path layer is removed after using the medical device obtained according to the example. Figure 7 (b) is a photograph replacing a drawing showing a case where a medical device without a resin layer is used. DETAILED DESCRIPTION

[0023] Hereinafter, the embodiment of the present invention will be described using the drawings. The present invention is not limited to the embodiment described below, and also includes an embodiment appropriately modified within the scope that should be understood by those skilled in the art based on the following embodiment.

[0024] Medical Devices1

[0025] The initial invention of this specification relates to a medical device 1 . Figure 1 This is a conceptual diagram showing an example of a medical device having a blood flow path layer. Figure 1 Medical devices shown. Figure 1 (a) shows an example of the appearance of the device. Figure 1 (b) shows an example of a blood flow path layer. Figure 1 (c) is an example showing the blood flow path. Figure 1 As shown, this medical device 1 has a blood flow path layer 3. The blood flow path layer 3 is usually multi-layered. The blood flow path layer 3 is a layer having a flow path for blood circulation. Moreover, each blood flow path layer 3 has a plate-shaped main body 5, a groove 9 and a resin layer 11. Examples of medical devices 1 are implantable artificial kidneys, portable artificial kidneys, hemodialyzers, blood filters, and extracorporeal membrane oxygenation. Blood filters also include continuous hemofiltration dialyzers. The components other than the resin layer 11 can appropriately use the materials described in Japanese Patent Gazette No. 2017-158814 and Japanese Patent Gazette No. 2020-22524.

[0026] The example of the blood filtration device 1 has a main body having a regular hexagonal outer shape. The main body has a stacked structure formed by stacking a plurality of plate-like members. In addition, a blood inlet, a blood outlet, and a filtrate outlet are provided on a surface on one side of the stacking direction of the main body. The blood inlet allows blood to flow into the main body, and the blood outlet allows blood in the main body to flow out. In addition, the filtrate outlet discharges the filtrate extracted from the blood after being filtered in the main body. The blood inlet, the blood outlet, and the filtrate outlet 5 are each in the shape of a connector that can be connected to a catheter.

[0027] The blood flow path layer has a blood flow path 7 through which blood flows. The filtrate flow path layer has a filtrate flow path through which filtrate flows. In the main body, the blood flow path layer and the filtrate flow path layer are arranged at a position where the blood flow path and the filtrate flow path are opposite to each other with a filter membrane interposed therebetween. The blood is filtered by the filter membrane while flowing through the blood flow path, and the plasma containing harmful substances and excess water in the blood flows through the filtrate flow path and is discharged from the filtrate outlet as filtrate.

[0028] Blood flow path layer 3

[0029] The blood flow path layer 3 is generally in the shape of a flat plate, and has a groove 9 in the plate-like main body 5, and the groove 9 will become the blood flow path 7. Medical devices usually have multiple blood flow path layers. Examples of the number of layers are more than 1 layer and less than 120 layers, more than 2 layers and less than 60 layers, more than 5 layers and less than 30 layers, or more than 5 layers and less than 20 layers. On the other hand, for example, in the case of a person (especially an adult) weighing more than 20 kg and less than 100 kg, examples of the number of layers are more than 1 layer and less than 300 layers, more than 1 layer and less than 240 layers, more than 1 layer and less than 120 layers, or more than 2 layers and less than 60 layers.

[0030] Plate-shaped main body part 5

[0031] The plate-like main body 5 may be made of, for example, a metal material such as titanium or stainless steel, a synthetic resin material such as plastic, or a ceramic material such as silicon or glass.

[0032] The groove 9 is formed in the plate-like main body 5 , and is an element for forming the blood flow path 7 .

[0033] The width of the flow path is preferably 0.01 mm or more and 1 cm or less, and may be 0.1 mm or more and 5 mm or less, or 0.5 mm or more and 4 mm or less. The thickness of the flow path is appropriately adjusted according to the thickness of the device and the number of layers. If the thickness of the flow path is too thick, the blood velocity will be too fast. If the thickness of the flow path is too thin, in addition to blood stagnation, the risk of impurities accumulating and causing flow path occlusion will also increase. From this point of view, the thickness of the flow path is preferably 0.01 mm or more and 1 cm or less, and may be 0.05 mm or more and 5 mm or less, or 0.1 mm or more and 3 mm or less.

[0034] Resin layer 11

[0035] The resin layer 11 is an element formed of resin on the side wall of the groove 9. Since the medical device has the resin layer 11 formed on the side wall of the groove 9, it is possible to prevent or reduce the situation where the groove is exposed or the groove contacts blood. Figure 2A conceptual diagram for explaining the resin layer. The resin layer 11 is present at least in the corner area 12 of the groove, and preferably makes the shape of the groove smooth. Therefore, the medical device of the present invention is capable of reducing the surface roughness of the blood contact surface without relying on the processing roughness of the groove. Furthermore, the resin layer 11 preferably covers the side walls of the groove. The resin layer 11 can cover the entirety of the groove (the two side walls and the upper and lower (left and right) walls). In other words, the entirety of the walls that constitute the blood flow path can also be covered by the resin layer. Since the plate-like main body 5 of this medical device does not come into contact with blood, the range of choices for the material of the plate-like main body 5 can be expanded. As Figure 2 As shown, the resin layer 11 preferably has a shape in which the bottom 14 and the top 16 are thicker than the center 18 of the height direction of the side wall of the groove 9, and the thickness changes gently. If it is such a shape, since the cross-section of the blood flow path 7 is close to a circle and an ellipse, the blood circulation becomes smooth, and the occurrence of thrombosis can be effectively prevented. In addition, the names of the height direction, the bottom and the top are for the convenience of explaining the resin layer, and it is not necessary to use the medical device with the bottom facing downward. This shape can be formed by the surface tension of the resin in accordance with the manufacturing method of the medical device described later. The width of the resin layer 11 (the width of the center 18 area) can be appropriately adjusted according to the width of the groove 9 (flow path), the type of resin, etc. An example of the width of the resin layer 11 is greater than 0.01 mm and less than 4 mm, preferably greater than 0.01 mm and less than 2 mm. In order to make the shape of the resin layer smooth, the lowermost portion 14 and the uppermost portion 16 of the resin layer are preferably thicker than the central portion 18 of the resin layer, and the lowermost portion 14 and the uppermost portion 16 of the resin layer are preferably thicker than the central portion 18 of the resin layer by 0.01 mm or more and 4 mm or less (preferably 0.05 mm or more and 1 mm or less). The lowermost portion 14 and the uppermost portion 16 of the resin layer are respectively connected to the lowermost portion 14 and the uppermost portion 16 of the resin layer 11 of the adjacent resin layer, and the periphery of the groove 9 may also be covered with a resin layer.

[0036] Figure 3 1 is a conceptual diagram for explaining the layer structure of a blood filtration device and a blood separation device. Figure 3 As shown, the medical device further comprises a filtrate flow path layer 23 and a filter membrane 31 .

[0037] Filtrate flow path layer 23

[0038] The filtrate flow path layer 23 refers to a layer having the filtrate flow path 21 arranged along the blood flow path 7 .

[0039] Filter membrane 31

[0040] The filter membrane 31 is interposed between the blood flow path layer 3 and the filtrate flow path layer 23, and is a membrane for filtering the blood flowing through the blood flow path 7. The filter membrane is a membrane that filters the blood to remove harmful substances and excess water, and is composed of a polymer membrane having many nano-scale pores. In this embodiment, a PES (polyethersulfone) membrane is used. The PES membrane can selectively filter only blood components with small molecular weight through nano-scale pores, and can remove harmful substances and excess water from the blood.

[0041] Manufacturing methods of medical devices

[0042] This method includes a resin coating step (S101), a bonding step (S103) and a post-curing step (S104). A pre-curing step (S102) may be included between the resin coating step (S101) and the bonding step (S103), or between the bonding step (S103) and the post-curing step (S104). Figure 4 A conceptual diagram used to illustrate the manufacturing stages of a medical device.

[0043] Resin coating process (S101)

[0044] The resin coating step (S101) is a step of coating resin on the grooves 9 of the plate-like main body 5 having the grooves 9 for forming the blood flow path 7. Examples of the resin are thermosetting resin and photocurable resin. Figure 4 (a) is a diagram showing an example of a cross section of a plate-like main body having a groove. Figure 4 The plate-like body 5 having the groove 9 shown in (a) can be appropriately prepared using the method described in, for example, Japanese Patent Application Publication Nos. 2017-158814 and 2020-22524. The method of applying the resin 10 to the groove 9 is known. The application method includes dip coating and spray coating. Figure 4 (b) is a conceptual diagram showing a state where the resin has been applied in the groove. In this figure, the resin is attached to the substrate main body 5. Dip coating is performed by simply dipping the plate-like main body in the resin. After the plate-like main body is completely immersed, the plate-like main body is removed from the resin and the remaining resin is removed from the groove. The conditions for dipping the plate-like main body in the resin (environment, direction of the plate-like main body, dipping speed, etc.), the dipping time, the conditions for removing the plate-like main body from the resin, and the method for removing the remaining resin can be appropriately adjusted.

[0045] Pre-hardening process (S102)

[0046] The pre-hardening step (S102) is an optional step for hardening the resin applied to the groove 9 in the resin application step. In this step, the resin is not completely hardened, but hardened to the extent that the resin has no fluidity. The pre-hardening step may not be performed. Figure 4(c) is a diagram for explaining an example of the pre-hardening process. Figure 4 As shown in (c), the resin can be cured by irradiating it with light (hv). The light irradiation time can be appropriately adjusted according to the photocurable resin and the light irradiation machine used. Examples of the light irradiation time are more than 1 second and less than 20 seconds, or more than 2 seconds and less than 15 seconds. In the case where the resin is a thermosetting resin, the resin can be cured by heating the resin. The pre-curing process (S102) does not require the resin to be completely cured. In the case where the resin is a photocurable resin, the same intensity of light is used in the pre-curing process and the post-curing process. For example, the pre-curing process only needs to irradiate light for a period of more than 1 / 100 and less than 1 / 5 of the post-curing process. Before the main body 5 is clamped by the films 41 and 42, the resin is slightly cured in advance in the pre-curing process, and after the main body 5 is clamped by the films 41 and 42, the resin applied to the films 41 and 42 can be cured in the post-curing process.

[0047] Bonding step (S103)

[0048] The bonding step ( S103 ) is a step of bonding the plate-like body 5 , the first film 41 , and the second film 43 by sandwiching the plate-like body 5 between the first film 41 and the second film 43 . Figure 4 (d) is a conceptual diagram showing the situation where the plate-like main body is clamped by the first membrane and the second membrane. Examples of the first membrane 41 and the second membrane 43 are the filter membrane 31 and the dialysis membrane. The membranes 41 and 43 preferably contain moisture and are not dried. If the membranes 41 and 43 are dry, it is conceivable that the resin will invade the pores inside the membrane through capillary phenomena, resulting in pore occlusion. Therefore, the process of adding moisture to the membranes 41 and 43 is a preferred example of the bonding process. In order to add moisture to the membranes 41 and 43, the membranes 41 and 43 can be immersed in water, or water can be applied to the membranes 41 and 43 by spraying. The membranes 41 and 43 are flexible, so for example, the membranes 41 and 43 can also be fixed to the substrate, and then the membranes 41 and 43 are bonded to the plate-like main body. For example, the polyethersulfone (PES) membrane is an asymmetric membrane composed of nanopores (dense layer) and micropores (support layer). In the case of a membrane with a dense layer and a support layer, it is preferred to make the dense layer on the side of the plate-like main body 5.

[0049] Preferably, the plate-like body 5 is left to stand after being sandwiched between the first film 41 and the second film 43. At this time, if the plate-like body 5 sandwiched between the first film 41 and the second film 43 is pressurized, the resin present in the plate-like body 5 may intrude into the flow path and the pores of the film.

[0050] Post-hardening process (S104)

[0051] The post-curing step (S104) is a step for curing the resin applied to the groove 9 in the resin coating step after the bonding step. When the resin is a photocurable resin, the resin can be cured by irradiating the resin with light. Figure 4 (e) is a conceptual diagram showing a state where an object formed by sandwiching a first film and a second film in a plate-like main body obtained in a bonding process is irradiated with light (hv) to cure the resin applied to the groove. In the case where the resin is a thermosetting resin, the resin can be cured by heating the resin. The light irradiation time can be appropriately adjusted according to the photocurable resin and the light irradiation machine used. Examples of the light irradiation time are 30 seconds or more and 10 minutes or less, and may also be 1 minute or more and 5 minutes or less. Figure 4 (f) is a conceptual diagram showing a partial view of the obtained medical device.

[0052] In the case where the medical device has a blood flow path layer and a filtrate flow path layer, it is preferred to make the filtrate flow path layer after making the blood flow path layer. On the other hand, it is also possible to make the filtrate flow path layer first and then make the blood flow path layer. Regarding the blood flow path layer, the presence or absence of bubbles in the adhesive has a great relationship with the surface state of the flow path, so it is preferred to check the presence or absence of bubbles by light transmission or ultrasound after confirming the assembly. In the case where the filtrate flow path layer is made before the blood flow path layer, this inspection will become difficult. From this point of view, in the case where the medical device has a blood flow path layer and a filtrate flow path layer, it is preferred to make the blood flow path layer before the filtrate flow path layer. The filtrate flow path of the filtrate flow path layer is not a flow path through which blood flows, so it is also possible not to form a resin layer in the flow path. In addition, the blood flow path layer and the filtrate flow path layer can also be bonded using, for example, an adhesive sheet.

[0053] Example

[0054] Medical devices are manufactured as follows. All processes are carried out in a positive pressure clean room or clean bench of Class 100,000 or above. Aseptic operation can be performed, and final sterilization can also be performed. Especially in the case of mass production of medical devices, the order of each process can also be greatly changed.

[0055] Process 1

[0056] The blood flow channel base and the filtrate flow channel base were cut out from a 300 μm PMMA plate (cast) using a laser processing machine. The distance between the laser and the PMMA plate was 5 mm, and the output was set to power: 20.00 watts / speed: 0.3 inches / second / PPI: 30,000 Hz.

[0057] Process 2

[0058] Ultraviolet curing resin (UV-curing adhesive LOCTITE 4304 manufactured by Henkel (main component: light-curing ethyl cyanoacrylate)) was sufficiently dripped into a glass petri dish to prepare an adhesive pool.

[0059] Process 3

[0060] The surface moisture of the dialysis membrane (made of polyethersulfone: 100×10×0.1 mm) stored in water was removed, and the dialysis membrane was fixed to the glass plate (100×100 mm) by utilizing the surface tension of the moisture on the glass plate. Two sets of this were prepared.

[0061] At this time, if the dialysis membrane is completely dried, the membrane strength of the final product will deteriorate, so only the excess moisture on the surface is removed.

[0062] When the dialysis membrane is dry, it is expected that the liquid will flow into the pores inside the membrane through the capillary phenomenon, and the pores will be completely blocked, so great care must be taken.

[0063] The polyethersulfone (PES) membrane is an asymmetric membrane composed of nanopores (dense layer) and micropores (support layer), so the nanopores are the surface on the glass plate.

[0064] Process 4

[0065] Use forceps to immerse the blood flow channel base into the adhesive pool.

[0066] Process 5

[0067] After the blood flow channel base is completely immersed in the adhesive bath, the blood flow channel base is taken out and the remaining adhesive is removed by gravity (using a scraper or the like as necessary).

[0068] Process 6

[0069] UV exposure machine (14±4W / m 2 ) to pre-harden the adhesive. The pre-hardening time is within 10 seconds. In addition, even without pre-hardening, it can actually be produced.

[0070] Process 7

[0071] The pre-cured blood flow channel base is bonded to the glass plate with the PES membrane prepared in step 3. At this time, the bonding is performed only by gravity, and no pressure (pressing) treatment is performed. If a pressing treatment is performed, it is expected that a large amount of adhesive will invade the flow channel, narrowing the flow channel width.

[0072] Process 8

[0073] UV exposure machine (14±4W / m 2 ) Irradiate the joined blood flow path base and PES membrane for more than 120 seconds for post-hardening.

[0074] Process 9

[0075] In order to prevent damage due to drying, the blood flow path assembly (PES membrane - blood flow path layer - PES membrane) was stored in water.

[0076] Process 10

[0077] The final layer stack is an alternating arrangement of "PES membrane - blood flow path layer - PES membrane - filtrate flow path layer - PES membrane - blood flow path layer...". As in step 4, the filtrate flow path base is immersed in the adhesive bath, and the filtrate flow path base is taken out to remove the remaining adhesive. In addition, since the filtrate flow path does not come into contact with blood, it is not necessary to use a flow path production method using an ultraviolet curing adhesive.

[0078] Process 11

[0079] The removed filtrate flow channel base was joined to the blood flow channel group and exposed to ultraviolet light (14 ± 4W / m 2 ) for more than 240 seconds to harden.

[0080] Process 12

[0081] The filtrate flow path base immersed in the pool is joined to the “PES membrane-blood flow path layer-PES membrane-filtrate flow path layer-PES membrane-blood flow path layer-PES membrane” and the blood flow path group produced in step 11 .

[0082] Process 13

[0083] Steps 10 to 12 are repeated to form a layered flow path.

[0084] Process 14

[0085] Remove the supporting portion of each flow path base.

[0086] The groove portion of the medical device obtained as described above is photographed. The obtained image is as follows Figure 5 shown. Figure 5 (a) is a photograph replacing the drawing of the groove portion obtained according to the example. Figure 5 (b) is a photograph of the drawing showing a groove portion where no resin layer is provided. Figure 5 As shown in (b), if no resin layer is provided, the groove portion is rectangular and thrombosis occurs in this portion. Figure 5 As shown in (a), the corners become rounded when the resin layer is provided. As a result, it is thought that the formation of thrombus can be alleviated by providing the resin layer.

[0087] Figure 6 This is a photograph showing the appearance of the obtained medical device instead of the attached figure. Blood was filtered using this medical device (blood filtration device). The results are as follows Figure 7 shown. Figure 7(a) is a photograph replacing a drawing showing a state where the blood flow path layer is removed after using the medical device obtained according to the example. Figure 7 (b) is a photograph replacing the drawing showing the case where a medical device without a resin layer is used. Figure 7 As shown in (b), when no resin layer is provided, thrombus is generated. Figure 7 As shown in (a), by providing the resin layer, no thrombus is generated in the blood flow path layer.

[0088] Possibility of Industrial Application

[0089] The present invention can be utilized in the field of medical devices.

[0090] Description of Reference Numerals

[0091] 1: Medical devices

[0092] 3: Blood flow path layer

[0093] 5: Plate-shaped main body

[0094] 7: Blood flow path

[0095] 9: Slot

[0096] 11: Resin layer

[0097] 21: Filtrate flow path

[0098] 23: Filtrate flow path layer

[0099] 31: Filter membrane

[0100] 41: First Film

[0101] 43: Second Film

Claims

1. A medical device (1) having a plurality of blood flow path layers (3), characterized in that: Each of the plurality of blood flow path layers (3) has: Plate-shaped main body (5); a groove (9) formed in the plate-like main body (5) and used to form a blood flow path (7); and a resin layer (11) formed on the side wall of the groove (9); In the medical device (1), the resin layer (11) has a shape in which the lowermost portion and the uppermost portion are thicker than the center portion in the height direction of the side wall of the groove (9), and the thickness changes gently.

2. The medical device (1) according to claim 1, characterized in that: Further having: a filtrate flow path layer (23) having a filtrate flow path (21) arranged along the blood flow path (7); and A filter membrane (31) is interposed between the blood flow path layer (3) and the filtrate flow path layer (23) and is used to filter the blood flowing through the blood flow path (7).

3. The medical device (1) according to claim 1, characterized in that: It is an implantable artificial kidney, a portable artificial kidney, a hemodialyzer, a hemofilter or extracorporeal membrane oxygenation.

4. A method for manufacturing a medical device, characterized in that: Include: a resin coating step of coating resin on the groove (9) of the plate-like main body (5) having the groove (9) for forming the blood flow path (7); a bonding step of bonding the plate-like main body (5), the first film (41) and the second film (43) by sandwiching the plate-like main body (5) with the first film (41) and the second film (43); and A post-hardening step is performed after the bonding step to harden the resin applied to the groove (9) in the resin application step.

5. The method for manufacturing a medical device according to claim 4, characterized in that: The medical device is the medical device according to any one of claims 1 to 3.

6. The method for manufacturing a medical device according to claim 5, characterized in that: The resin is a photocurable resin, and the post-curing step is a step of curing the resin by irradiating the resin with light.

7. The method for manufacturing a medical device according to claim 6, characterized in that: Further including: a pre-hardening step of hardening the resin by irradiating light onto the resin applied to the groove (9) in the resin application step; The bonding process is a process after the pre-hardening process; The pre-curing step is a step of irradiating the light for a period of not less than 1 / 100 and not more than 1 / 5 of the period of the post-curing step.

Images