Medical instrument

Abstract

This medical instrument (10) is provided with a pressing part (21) that is disposed in contact with tissue and an organ in a living body and presses the tissue and the organ. A frictional force imparting sheet is fixed to a surface (21d) of the pressing part (21). The frictional force imparting sheet is preferably a mesh-like woven fabric (23).

Description

medical equipment

[0001] This application claims priority from Japanese Patent Application No. 2024-105522, filed on June 28, 2024, the contents of which are incorporated herein by reference.

[0002] Conventionally, gastrointestinal examinations and gastrointestinal endoscopic surgeries have been performed using endoscopes and medical balloons. When inflated within a patient's gastrointestinal tract, the medical balloon compresses the tissues and organs present around the medical balloon, thereby expanding the gastrointestinal tract from the inside. For example, a medical balloon is described in Patent Document 1.

[0003] Patent Document 1 describes an endoscopic device including an endoscope having an insertion portion and a substantially cylindrical insertion aid having an insertion passage through which the insertion portion is inserted. Patent Document 1 describes an insertion aid for an endoscopic device that includes an inflatable balloon on the outer periphery of a tip portion, an opening formed on the outer periphery of the tip portion and communicating with the balloon, a conduit for a balloon fluid that is separate from the insertion passage and communicates with the opening, an air vent formed on the tip surface or outer periphery, and an air vent conduit that is separate from the insertion passage and the conduit for the balloon fluid that is communicated with the air vent.

[0004] Furthermore, in recent years, endoscopic surgery, such as laparoscopic surgery and thoracoscopic surgery, has become widely used as minimally invasive medical treatment. Endoscopic surgery involves inserting an endoscope and long, thin, rod-shaped medical instruments into the patient's body through a small hole in the skin, and operating the medical instruments while viewing images of the inside of the body taken by the endoscope. Compared to open surgery, which requires a large incision in the patient's abdomen, endoscopic surgery has the advantage of causing less scarring and bleeding and allowing patients to recover more quickly after surgery.

[0005] During endoscopic surgery, it is necessary to secure a working space (treatment space) within the patient's body during surgery in order to operate the endoscope and medical instruments. For this reason, in endoscopic surgery, a retraction device is usually used to retract and remove tissues and organs around the area to be treated within the body, thereby securing the working space. Examples of retraction devices include a brain spatula and retraction forceps.

[0006] U.S. Patent No. 5,629,999 describes a surgical retractor having deployable blades for use with an endoscopic or laparoscopic device when performing an examination or surgical procedure within a body cavity. U.S. Patent No. 5,629,999 describes a surgical retractor that includes a collapsible retractor assembly connected to the distal end of a housing.

[0007] Patent Document 3 describes a balloon-type organ displacement and lifting device used to compress and lift tissue during laparoscopic or thoracoscopic surgery. Patent Document 3 describes a balloon-type organ displacement and lifting device that includes an elastic and plastic balloon that can be expanded and contracted, a cord portion containing at least a tube for supplying or defusing air to or from the balloon, and a control portion that controls supplying or defusing air to or from the balloon.

[0008] Patent Document 4 describes the structure of a retractor that compresses even relatively soft organs during laparoscopic surgery to ensure a clear surgical field. Patent Document 4 also describes a medical exclusion hook that consists of an opening / closing part that moves to form a spatula, a rod part, and a grip part, and when the grip part is gripped, the movement slides an inner rod inside the rod part, opening the opening / closing part to form a spatula of a predetermined area.

[0009] Patent No. 5001082 JP 5-200040 JP 2011-239857 JP 6-154152

[0010] Conventionally, medical devices such as medical balloons and exclusion devices that are placed in a predetermined position in a patient's body and maintained in that position for a certain period of time in contact with tissues and organs in the body have had the disadvantage of being prone to slipping out of the predetermined position in the body, which can impair the workability, accuracy, and stability of the intended examination and / or treatment.

[0011] One possible solution to this problem is to increase the pressure of the medical instrument on the tissues and organs. However, increasing the pressure of the medical instrument on the tissues and organs in order to prevent the medical instrument placed in the living body from shifting position increases the load on the tissues and / or organs. This may cause damage to the tissues and / or organs. In particular, with medical instruments that press against the colon wall from the inside, it is difficult to increase the pressure because there is a risk of perforation of the thin colon wall, and if the colon wall perforates, bacteria in the intestinal tract may cause peritonitis or other conditions.

[0012] Furthermore, one of the reasons why the above-mentioned medical instruments may shift from their installed positions is that the lubricity of the medical instruments against the tissues and organs in the living body is increased due to mucus such as secretions secreted from the tissues and organs and / or liquids present in the living body. For this reason, a method has been used in which a woven fabric that absorbs mucus such as secretions is placed between the retraction instrument and the tissues and organs in the living body to prevent the retraction instrument placed in the living body from shifting from its installed position.

[0013] However, this method sometimes fails to sufficiently prevent displacement of the exclusion device placed in the living body. For this reason, conventional techniques have been required to more effectively prevent displacement of medical devices. The present invention has been made in view of the above problems, and aims to provide a medical device that is less likely to displace from its placed position in the living body and is easily maintained at a predetermined position in the living body.

[0014] The present inventors have focused on the material and shape of the pressing part, which comes into contact with tissues and organs in a living body and is moistened by mucus such as secretions and / or liquids present in the living body, in a medical device that is placed in contact with the tissues and organs in a living body and has pressed against the tissues and organs, and have conducted extensive research as described below.

[0015] That is, in the conventional method of placing a woven fabric that absorbs mucus such as secretions and / or other liquids present in the living body between the retraction device and the tissues and organs of the living body, the woven fabric may not sufficiently absorb the liquid, causing the tissues and organs of the living body to become wet with the liquid. In this case, the retraction device and the woven fabric are likely to become misaligned, and it is not possible to sufficiently prevent the retraction device placed in the living body from becoming misaligned.

[0016] Therefore, the present inventors have focused on the displacement of a medical instrument from tissues and organs when the tissues and organs in a living body are moistened by the above-mentioned liquid, and have conducted extensive research. As a result, they have discovered that by fixing a friction-imparting sheet to the surface of the pressing part and increasing the friction coefficient of the pressing part with respect to tissues and organs in a living body moistened by mucus such as secretions and / or liquids present in the living body, a medical instrument is obtained that is less likely to displace from its predetermined position after being placed at a predetermined position in the living body, and have conceived the present invention. The present invention provides the following means.

[0017] [1] A medical device comprising a pressing part that is placed in contact with tissues and organs in a living body and presses against the tissues and organs, wherein a friction-imparting sheet is fixed to the surface of the pressing part.

[0018] [2] The medical device according to [1], wherein the frictional force imparting sheet is a mesh woven fabric. [3] The medical device according to [1], wherein the frictional force imparting sheet is made of one layer of mesh woven fabric.

[0019] [4] The medical device according to [2], wherein the mesh fabric is made of one to three laminated layers of cotton. [5] The medical device according to [2], wherein the mesh fabric is made of one to three laminated layers of polyethylene.

[0020] [6] The medical device according to [1], wherein the pressing portion is a balloon portion that can be expanded and contracted. [7] The medical device according to [6], wherein the frictional force-imparting sheet is pressed against and fixed to the balloon portion by the expansion of the balloon portion.

[0021] [8] The medical device according to [6], wherein the balloon portion is tubular and is formed into a spiral shape by supplying a fluid into the balloon portion, and the spiral shape presses outward from the central axis of the spiral shape. [9] The medical device according to [6], wherein the balloon portion is placed in the large intestine and presses against the large intestine wall by supplying a fluid into the balloon portion.

[10] The medical device according to [1], wherein the pressing portion is an exclusion device that excludes the tissue and the organ.

[0022]

[11] The medical device according to [2], wherein the mesh fabric is made of polyurethane and / or polyethylene terephthalate.

[12] The medical device according to [2], wherein the mesh fabric is a cloth woven in a mesh shape from filaments formed by bundling a plurality of threads.

[13] The medical device according to

[12] , wherein the filaments are made of one or more core materials made of a first fiber and one or more covering materials made of a second fiber of a different type from the first fiber and spirally wound around the core material.

[0023] The medical device of the present invention is a medical device comprising a pressing portion that is placed in contact with tissues and organs in a living body and presses against the tissues and organs, and a friction-imparting sheet is fixed to the surface of the pressing portion. The pressing portion having the friction-imparting sheet fixed to its surface has a high coefficient of friction with tissues and organs in a living body that are wetted with mucus such as secretions and / or other liquids present in the living body. As a result, the medical device of the present invention is less likely to shift from its position in the living body and is more likely to remain in a predetermined position in the living body. Therefore, with the medical device of the present invention, it is not necessary to increase the pressing force of the medical device against the tissues and organs to prevent the medical device from shifting position after being placed in the living body, and the load caused by the pressing force of the medical device on the tissues and organs can be reduced.

[0024] FIG. 1( a) is a schematic perspective view illustrating a medical device according to a first embodiment. FIG. 1( b) is a schematic cross-sectional view taken along line A-A' in FIG. 1( a). FIG. 2 is a schematic perspective view illustrating the state in which the medical device shown in FIG. 1 is placed in the large intestine. FIG. 3 is a perspective view illustrating a medical device according to a second embodiment. FIG. 4 is a side view illustrating a friction test apparatus. FIG. 5 is a photograph of the mesh-like woven fabric used in Example 14. FIG. 6 is a photograph of the mesh-like woven fabric used in Example 15. FIG. 7 is a photograph of the mesh-like woven fabric used in Example 16. FIG. 8 is a photograph of the mesh-like woven fabric used in Example 17. FIG. 9 is a schematic cross-sectional view illustrating another example of a balloon portion 210 provided in the medical device of this embodiment. FIG. 10( a) is a plan view illustrating a part of a process for manufacturing the balloon portion 210 shown in FIG. 9. FIG. 10( b) is a schematic cross-sectional view taken along line B-B' in FIG. 10( a). 11(a) is a plan view showing a part of the process for manufacturing the balloon portion 210 shown in Fig. 9. Fig. 11(b) is a schematic cross-sectional view taken along line CC' shown in Fig. 11(a). Fig. 12 is an explanatory diagram for explaining a method for manufacturing the medical device 10 having the balloon portion 210 shown in Fig. 9.

[0025] The medical device according to this embodiment will be described in detail below with reference to the drawings as appropriate. The drawings used in the following description may show characteristic portions enlarged for the sake of convenience in order to make the features of this embodiment easier to understand, and the dimensional ratios of each component may differ from the actual ones. The materials, dimensions, etc. exemplified in the following description are merely examples, and the present invention is not limited thereto and may be modified as appropriate within the scope of the present invention.

[0026] [First embodiment] Fig. 1(a) is a schematic perspective view for explaining a medical device according to a first embodiment. Fig. 1(b) is a schematic cross-sectional view taken along line AA' shown in Fig. 1(a). Fig. 2 is a schematic perspective view for explaining the state in which the medical device shown in Fig. 1 is placed in the large intestine.

[0027] As shown in Fig. 1(a), the medical device 10 of this embodiment includes an inflatable and deflated balloon portion 21, a flexible printed circuit (FPC) portion 22, a mesh woven fabric 23 serving as a frictional force imparting sheet, a connection portion 31, a conductive cable 32, and a fluid supply / discharge tube 33. Figs. 1(a), 1(b), and 2 are drawings showing the balloon portion 21 of the medical device 10 in an inflated state.

[0028] 2 , the medical device 10 of this embodiment has a balloon portion 21 placed in the large intestine 5. The balloon portion 21 of the medical device 10 is preferably placed in any one of the ascending colon, transverse colon, or descending colon, where the water content of the contents in the large intestine 5 is relatively high, and is particularly preferably placed in the ascending colon or transverse colon, where the water content is particularly high. The reason for this is that the balloon portion 21 placed at a predetermined position in the large intestine 5 is prevented from shifting from the predetermined position by being pushed out toward the anus together with the contents in the large intestine 5, and is therefore more likely to remain placed at the predetermined position in the large intestine 5.

[0029] [Balloon portion 21] The medical device 10 of this embodiment presses so as to expand the large intestine wall 51 when a fluid is supplied into the balloon portion 21. Therefore, in the medical device 10 of this embodiment, the balloon portion 21 is disposed in contact with the large intestine wall 51 of the large intestine 5, and functions as a pressing portion that presses tissues and organs in the living body.

[0030] As shown in Figures 1(a) and 1(b), the balloon portion 21 is tubular and has a generally elliptical cross section when the balloon portion 21 is inflated. The balloon portion 21 is molded into a spiral shape while expanding when a fluid is supplied into the balloon portion 21. As a result, the balloon portion 21 becomes a molded body having a spiral shape, as shown in Figure 1(a), and is pressed outward from the central axis of the spiral shape.

[0031] 2, the balloon portion 21 presses substantially evenly against the large intestine wall 51 of the large intestine 5 from the inside to the outside. This makes it difficult for the balloon portion 21 to shift from its installed position within the large intestine 5, and makes it easier to more reliably maintain the state in which it is installed at a predetermined position within the large intestine 5. Furthermore, because the balloon portion 21 presses substantially evenly against the large intestine wall 51 from the inside to the outside, when the balloon portion 21 is maintained in a state in which it is installed at a predetermined position within the large intestine 5, the load on the large intestine 5 and its vicinity caused by the pressure of the balloon portion 21 can be reduced, and invasion of the large intestine 5 and its vicinity can be suppressed.

[0032] The balloon portion 21 is made of a resin sheet 21a. As shown in Fig. 1(b) , the balloon portion 21 is formed into a ring shape by folding a strip-shaped resin sheet 21a in three widthwise directions and bonding both overlapping widthwise ends of the resin sheet 21a with a bonding layer 21c. Both longitudinal ends of the balloon portion 21 are sealed by bonding the resin sheet 21a folded in three with a bonding layer (not shown).

[0033] The resin sheet 21a forming the balloon portion 21 is flexible and may be made of, for example, a silicone resin sheet, a polyurethane resin sheet, a vinyl chloride resin sheet, etc. Among these resin sheets 21a, it is preferable to use a silicone resin sheet because it is inexpensive, is a highly safe material that is widely used as a material for medical instruments used in the digestive tract, and is therefore suitable.

[0034] The thickness of the resin sheet 21a forming the balloon portion 21 in a deflated state can be, for example, 0.2 mm to 2.0 mm, and preferably 0.5 mm to 1.0 mm. When the thickness of the resin sheet 21a is 2.0 mm or less, the balloon portion 21 in a deflated state is sufficiently small. This makes it easy to place and retrieve the balloon portion 21 in the large intestine 5. Furthermore, when the thickness of the resin sheet 21a is 2.0 mm or less, the balloon portion 21 is likely to have sufficient flexibility and stretchability, which is preferable. Furthermore, when the thickness of the resin sheet 21a forming the balloon portion 21 in a deflated state is 0.2 mm or more, the balloon portion 21 is likely to have sufficient strength.

[0035] The resin sheet 21a forming the balloon portion 21 in a deflated state preferably has a hardness of, for example, 5° to 40°, more preferably 15° to 25°, as measured with a Type A durometer. When the hardness of the resin sheet 21a measured with a Type A durometer is 40° or less, the balloon portion 21 has sufficient flexibility and stretchability. Therefore, invasion of the large intestine 5 and its surroundings caused by pressure from the balloon portion 21 can be effectively suppressed. More specifically, the inner surface of the large intestine wall 51 is unevenly formed by crescent folds 52 and colonic distension (haustra) 53, etc. This is because, when the balloon portion 21 has sufficient flexibility and stretchability, the balloon portion 21, which is formed into a spiral shape in an inflated state, can press the large intestine wall 51 approximately evenly from the inside to the outside, following the uneven inner surface shape of the large intestine wall 51. Furthermore, if the hardness of the resin sheet 21a measured with a Type A durometer is 40° or less, the balloon portion 21 will have sufficient flexibility, and therefore the balloon portion 21 can be easily rolled up into a thin shape when in a deflated state, making the balloon portion 21 easy to install in and retrieve from the large intestine 5.

[0036] Furthermore, if the resin sheet 21a forming the balloon portion 21 in the deflated state has a hardness of 5° or more as measured with a type A durometer, the balloon portion 21 will have sufficient rigidity. Therefore, when a fluid is supplied to the balloon portion 21, the balloon portion 21 will be easily molded into a predetermined spiral shape while expanding.

[0037] The length of the balloon portion 21 in its deflated state is preferably equal to or greater than the length of the inner circumference of the large intestine wall 51 along a direction substantially perpendicular to the longitudinal direction of the large intestine 5. In this case, the balloon portion 21 is more likely to be formed in contact with the entire inner circumference of the large intestine 5, and a balloon portion 21 that can apply substantially uniform pressure to the entire inner circumference of the large intestine wall 51 is more preferably equal to or greater than 1.5 times the length of the inner circumference of the large intestine wall 51 along a direction substantially perpendicular to the longitudinal direction of the large intestine 5. The length of the balloon portion 21 in its deflated state is preferably equal to or less than twice the length of the inner circumference of the large intestine wall 51 along a direction substantially perpendicular to the longitudinal direction of the large intestine 5. This is because it facilitates placement within and retrieval from the large intestine 5.

[0038] The length of the inner circumference of the large intestine wall 51 in a direction substantially perpendicular to the longitudinal direction of the large intestine 5 of an adult human is in the range of 4 cm to 6 cm. Therefore, specifically, the length of the balloon portion 21 in a deflated state is preferably, for example, 19.0 cm to 37.8 cm, and more preferably 28.0 cm to 29.0 cm.

[0039] If the length of the balloon portion 21 in the deflated state is 19.0 cm or more, the contact area between the balloon portion 21 in the inflated state and the large intestine wall 51 is more likely to be secured. As a result, the balloon portion 21 is less likely to shift from its installed position in the large intestine 5, and is more likely to be more reliably maintained at a predetermined position in the large intestine 5. Furthermore, if the length of the balloon portion 21 in the deflated state is 19.0 cm or more, the balloon portion 21 in the inflated state is more likely to become a spiral-shaped body in the large intestine 5, which is preferable.

[0040] Furthermore, if the length of the balloon portion 21 in the deflated state is 37.8 cm or less, the balloon portion 21 in the deflated state can be easily placed in and retrieved from the large intestine 5. Therefore, invasion of the large intestine 5 and its vicinity caused by the placement and retrieval of the balloon portion 21 can be effectively suppressed.

[0041] It is preferable that the thickness of the balloon portion 21 when in a deflated state (in other words, the width of the tube forming the balloon portion 21 when in a deflated state) is such that, in a cross section along a direction approximately perpendicular to the longitudinal direction of the large intestine 5, the area of ​​the balloon portion 21 formed into a spiral shape when inflated is less than half the area of ​​the large intestine 5.

[0042] Specifically, the thickness of the balloon portion 21 in the deflated state is preferably, for example, 6.5 mm to 15.0 mm, and more preferably 7.0 mm to 10.0 mm. If the thickness of the balloon portion 21 in the deflated state is 6.5 mm or more, fluid can be easily supplied into the balloon portion 21, and the balloon portion 21 can be easily formed into a predetermined spiral shape.

[0043] Furthermore, if the thickness of the balloon portion 21 in the deflated state is 15.0 mm or less, the spirally shaped balloon portion 21 in the inflated state is less likely to impede the movement of contents within the large intestine 5, effectively preventing obstruction of the large intestine 5. This further reduces invasion of the large intestine 5 and its surrounding area caused by pressure from the balloon portion 21. Furthermore, if the thickness of the balloon portion 21 in the deflated state is 15.0 mm or less, when the medical device 10 of the present embodiment is used together with a function-adding device that uses the medical device 10 of the present embodiment as a scaffold, as will be described later, it becomes easier to ensure an operating area for the function-adding device.

[0044] Furthermore, if the thickness of the balloon portion 21 in its deflated state (in other words, the width of the tube forming the balloon portion 21 in its deflated state) is 15.0 mm or less, the balloon portion 21 in its deflated state can be easily placed in and retrieved from the large intestine 5. Therefore, invasion of the large intestine 5 and its vicinity caused by the placement and retrieval of the balloon portion 21 can be effectively suppressed.

[0045] 1(b), glassine paper 21b is bonded by a bonding layer 21e to the inner surface of the balloon portion 21 in the region where both widthwise ends of the strip-shaped resin sheet 21a are overlapped. In this embodiment, glassine paper 21b is bonded to the above region within the balloon portion 21, which prevents the inner surfaces of the balloon portion 21 from sticking together when in a deflated state, which would make it difficult to supply fluid into the balloon portion 21 or difficult to expand the balloon portion 21. Known glassine paper 21b can be used, and it is preferable that it is impregnated with a silicone resin.

[0046] In this embodiment, the bonding layer 21c that bonds both widthwise ends of the strip-shaped resin sheet 21a that has been folded into thirds and overlapped, and the bonding layers (not shown) that bond the resin sheets 21a in a third-folded state at both longitudinal ends of the balloon portion 21, are made of a known adhesive that can bond the resin sheets 21a together, and can be appropriately determined depending on the material of the resin sheets 21a. For example, if the resin sheet 21a is made of a silicone resin sheet, a known silicone resin-based adhesive can be used as the bonding layer 21c and the bonding layer (not shown) that bonds the resin sheets 21a in a third-folded state.

[0047] In this embodiment, the bonding layer 21e that bonds the glassine paper 21b to the inner surface of the balloon portion 21 is made of a known adhesive and is appropriately determined depending on the material of the resin sheet 21a. For example, if the resin sheet 21a is made of a silicone resin sheet, a known silicone resin-based adhesive can be used for the bonding layer 21e, as with the bonding layer 21c. The bonding layer 21c and the bonding layer 21e may be the same or different.

[0048] [Flexible Printed Circuit Board (FPC) Section 22] As shown in Fig. 1(a), the flexible printed circuit board section 22 is strip-shaped. As shown in Figs. 1(a) and 1(b), the flexible printed circuit board section 22 is disposed on the surface 21d of the balloon section 21, facing the area where both widthwise ends of the strip-shaped resin sheet 21a are overlapped. The flexible printed circuit board section 22 is integrated with the balloon section 21 by being bonded by a bonding layer 21f.

[0049] 1(a), when a fluid is supplied into the balloon portion 21, the flexible printed wiring board portion 22 forms a spiral-shaped molded article together with the balloon portion 21. As shown in FIG. 1(a), the flexible printed wiring board portion 22 is disposed on the central axis side of the spiral-shaped molded article formed by the balloon portion 21 in an expanded state.

[0050] The surface of the flexible printed wiring board part 22 opposite to the balloon part 21 (the lower surface in FIG. 1( b )) is used as a device mounting surface on which a function-adding device is installed when the medical instrument 10 of this embodiment is used together with a function-adding device that uses the medical instrument 10 of this embodiment as a scaffold, as will be described later. The function-adding device installed on the surface opposite to the balloon part 21 is electrically connected to the metal wiring 22d of the flexible printed wiring board part 22 by a known method. Therefore, the flexible printed wiring board part 22 can be used as a power supply means for supplying power to the function-adding device.

[0051] As shown in FIG. 1(b), the flexible printed wiring board portion 22 includes a resin sheet 22a that is folded in half widthwise and extends in the longitudinal direction of the balloon portion 21, a laminate consisting of a wiring layer 22b and a liquid crystal polymer layer 22c that are arranged between the folded resin sheets 22a, and a bonding layer 22f that bonds the folded resin sheets 22a together along the edges of the resin sheets 22a.

[0052] The resin sheet 22a has flexibility similar to the resin sheet 21a forming the balloon portion 21, and may be made of, for example, a silicone resin sheet, a polyurethane resin sheet, a vinyl chloride resin sheet, a polyimide resin sheet, etc. The thickness and hardness of the resin sheet 22a may be such that the balloon portion 21 can be easily installed and removed when the flexible printed wiring board portion 22 and the balloon portion 21 are integrated together. The resin sheet 22a may be the same as or different from the resin sheet 21a forming the balloon portion 21.

[0053] The length of the resin sheet 22a is preferably approximately the same as the length of the balloon portion 21 in the contracted state so that the balloon portion 21 can be installed and retrieved without hindrance when the flexible printed wiring board portion 22 and the balloon portion 21 are integrated together. Furthermore, the width of the resin sheet 22a folded in half in the width direction is preferably approximately the same as the width of the balloon portion 21 in the contracted state so that the balloon portion 21 can be installed and retrieved without hindrance when the flexible printed wiring board portion 22 and the balloon portion 21 are integrated together.

[0054] In this embodiment, the bonding layer 22f that bonds the folded resin sheets 22a together is made of a known adhesive that can bond the resin sheets 22a together, and is appropriately determined depending on the material of the resin sheets 22a. For example, if the resin sheets 22a are made of a silicone resin sheet, a known silicone resin-based adhesive can be used as the bonding layer 22f.

[0055] The laminate, which is made up of the liquid crystal polymer layer 22c disposed between the folded resin sheets 22a and the wiring layer 22b provided in contact with the liquid crystal polymer layer 22c, has a strip-shaped region and a connection region. The strip-shaped region is integrated with the resin sheet 22a while sandwiched between the folded resin sheets 22a, and extends in the longitudinal direction of the balloon portion 21. The connection region is exposed from the resin sheet 22a and extends from one end of the strip-shaped region in a direction intersecting the longitudinal direction.

[0056] In this embodiment, the connection region of the laminate consisting of the liquid crystal polymer layer 22c and the wiring layer 22b is exposed from the resin sheet 22a at the end of the flexible printed wiring board 22 on the side of the connection portion 31, as shown in FIG. 1(a), extends in a direction intersecting the longitudinal direction of the flexible printed wiring board 22, and is connected to the connection portion 31. This is preferable because, when the balloon portion 21 integrated with the flexible printed wiring board 22 is formed into a spiral shape in the large intestine 5, it is possible to prevent the connection portion 31 and / or the conductive cable 32 from coming into contact with the large intestine wall 51 or the connection portion 31 and / or the conductive cable 32 from interfering with the movement of contents within the large intestine 5. It is more preferable that the connection region extends from one end of the band-shaped region in a direction approximately perpendicular to the longitudinal direction.

[0057] In addition, in the present embodiment, the laminate has been described as having a strip region and a connection region that is exposed from the resin sheet 22a and extends from one end of the strip region in a direction intersecting the longitudinal direction, but the connection region may be exposed from the resin sheet 22a and, like the strip region, extend in the longitudinal direction of the balloon portion 21. In addition, in the present embodiment, the width of the laminate (in other words, the length in the direction intersecting the extending direction of the laminate) may be, for example, 10 mm.

[0058] The liquid crystal polymer layer 22c is made of a liquid crystal polymer, which is a thermoplastic resin, and has sufficient insulating properties, appropriate rigidity, and little stretchability. For the liquid crystal polymer layer 22c, known materials that can be used as substrate materials in flexible printed wiring boards, such as liquid crystal polymer, polyurethane resin, and polyimide resin, can be used.

[0059] In the medical device 10 of this embodiment, the flexible printed wiring board 22 is made of a liquid crystal polymer, which is a thermoplastic resin, and includes a liquid crystal polymer layer 22c that has sufficient insulation properties, appropriate rigidity, and little stretchability. Therefore, when the balloon portion 21 integrated with the flexible printed wiring board 22 is inflated, the expansion of the balloon portion 21 in the length direction is suppressed and the expansion of the balloon portion 21 in the width direction is promoted. As a result, when a fluid is supplied into the balloon portion 21, the balloon portion 21 integrated with the flexible printed wiring board 22 is easily formed into a spiral shape, and the flexible printed wiring board 22 is positioned on the central axis side of the spiral shape of the balloon portion 21 (see FIG. 1( a)).

[0060] Furthermore, in the medical device 10 of this embodiment, since the flexible printed wiring board portion 22 has the liquid crystal polymer layer 22c, the balloon portion 21 can be formed into a predetermined spiral shape when a fluid is supplied into the balloon portion 21, for example, by using the method described below.

[0061] As shown in FIG. 1B, the wiring layer 22b disposed between the folded resin sheets 22a includes a plurality of metal wirings 22d and an insulating layer 22g. The metal wirings 22d are made of a metal such as copper. As shown in FIG. 1A, the plurality of metal wirings 22d extend substantially parallel to the longitudinal direction of the resin sheet 22a. At the end of the flexible printed wiring board portion 22 on the side of the connection portion 31, the plurality of metal wirings 22d are each bent in the same direction intersecting the longitudinal direction of the flexible printed wiring board portion 22 and electrically connected to the connection portion 31.

[0062] The number of metal wires 22d is not particularly limited, and is determined depending on the number of metal wires 22d used to supply power to a function-added device when the medical device 10 of the present embodiment is used together with the function-added device that uses the medical device 10 of the present embodiment as a scaffold.

[0063] The width and thickness of the metal wiring 22d preferably have a sufficiently large cross-sectional area so as to adequately suppress heat generation from the metal wiring 22d due to power supply to the function-added device described later through the metal wiring 22d. Furthermore, the width of the metal wiring 22d is preferably sufficiently narrow so as to ensure a sufficient number of metal wirings 22d. Furthermore, the thickness of the metal wiring 22d is preferably sufficiently thin so as to suppress the thickness of the wiring layer 22b. The width of the metal wiring 22d can be, for example, 1.0 mm to 10.0 mm. The thickness of the metal wiring 22d can be, for example, 5 μm to 150 μm.

[0064] The total thickness of the liquid crystal polymer layer 22c and the metal wiring 22d is preferably 25 μm to 75 μm. When the total thickness is 25 μm or more, the flexible printed wiring board unit 22 having the liquid crystal polymer layer 22c and the metal wiring 22d can be easily manufactured. Furthermore, when the total thickness is 75 μm or less, the flexibility of the flexible printed wiring board unit 22 is not impaired by the presence of the liquid crystal polymer layer 22c and the metal wiring 22d. As a result, placement in and recovery from the large intestine 5 is facilitated.

[0065] The insulating layer 22g insulates adjacent metal wirings 22d and covers the surface of the metal wirings 22d opposite to the liquid crystal polymer layer 22c. The insulating layer 22g may be made of a known insulating material, such as solder resist.

[0066] In the medical device 10 of this embodiment, as shown in Figures 1(a) and 1(b), a superelastic alloy wire 22e is disposed between a resin sheet 22a folded in half. The superelastic alloy wire 22e is disposed in contact with the inner side of the folded portion of the resin sheet 22a, and is thereby surrounded by the resin sheet 22a. The superelastic alloy wire 22e is made of a superelastic alloy (SEA (Super Elastic Alloy)) that exhibits a superelastic effect. For example, a Ti-Ni alloy can be used as the superelastic alloy.

[0067] In the medical device 10 of this embodiment, the flexible printed wiring board 22 includes the superelastic alloy wire 22 e. Therefore, for example, by performing a known shape memory treatment on the superelastic alloy wire 22 e while the flexible printed wiring board 22 and the balloon portion 21 are integrated, the balloon portion 21 can be trained to assume a predetermined spiral shape when a fluid is supplied into the balloon portion 21.

[0068] The length of the superelastic alloy wire 22e is not particularly limited, but is preferably approximately the same as the length of the resin sheet 22a, as shown in Fig. 1(a) . This is because the balloon portion 21 is likely to assume a predetermined spiral shape when a fluid is supplied into the balloon portion 21. The number of superelastic alloy wires 22e may be one, as shown in Fig. 1(b), or multiple.

[0069] The width of the superelastic alloy wire 22e is preferably in the range of 300 μm to 500 μm. When the width of the superelastic alloy wire 22e is 300 μm or more, the shape retention of the superelastic alloy wire 22e is effectively obtained. Therefore, the balloon portion 21 is more likely to assume a predetermined spiral shape when a fluid is supplied into the balloon portion 21. Furthermore, when the width of the superelastic alloy wire 22e is 500 μm or less, the balloon portion 21 is prevented from being crimped by storing the balloon portion 21 in a contracted state, which makes it difficult for the balloon portion 21 to assume a predetermined spiral shape when a fluid is supplied into the balloon portion 21. When the flexible printed wiring board portion 22 has multiple superelastic alloy wires 22e, the total width of the multiple superelastic alloy wires 22e is preferably in the range of 300 μm to 500 μm.

[0070] In this embodiment, the flexible printed wiring board portion 22 has been described as having a superelastic alloy wire 22e, but the superelastic alloy wire 22e is optional and may be omitted. When the flexible printed wiring board portion 22 has the superelastic alloy wire 22e, the superelastic alloy wire 22e can be used to shape the balloon portion 21 into a predetermined spiral shape. Therefore, the liquid crystal polymer layer 22c does not need to be used to shape the balloon portion 21 into a predetermined spiral shape. Therefore, when the flexible printed wiring board portion 22 has the superelastic alloy wire 22e, an insulating layer such as a polyimide layer may be provided in place of the liquid crystal polymer layer 22c.

[0071] [Mesh Woven Fabric 23] In the medical device 10 of this embodiment, as shown in Figures 1(a) and 1(b), the balloon portion 21 integrated with the flexible printed wiring board portion 22 is made of a mesh woven fabric 23 as a friction-imparting sheet and is housed in a long, tubular bag with one end closed. As shown in Figure 1(b), when the balloon portion 21 expands, the mesh woven fabric 23 is pressed against and fixed to the surface 21d of the balloon portion 21. In the medical device 10 of this embodiment, the mesh woven fabric 23 is used as a friction-imparting sheet, which preferably provides a sufficiently high coefficient of friction against tissues and organs in a living body that are wet with mucus, such as secretions, and / or liquids present in the living body.

[0072] The mesh fabric 23 provided in the medical device 10 of this embodiment is formed into a long, tubular bag with one end closed by folding a strip of mesh fabric 23 in half and gluing it along the edge 23a. In this embodiment, the edge 23a of the folded strip of mesh fabric 23 may be sewn together using thread, needles, etc., instead of or in addition to gluing. The long, tubular bag with one end closed may be a long, tubular bag made of mesh fabric 23 woven seamlessly into a tubular shape, with one end closed.

[0073] The mesh woven fabric 23 may be joined to the flexible printed wiring board 22 using a known adhesive or the like. In this case, the joint between the mesh woven fabric 23 and the flexible printed wiring board 22 is preferably formed over the entire length of the flexible printed wiring board 22. Furthermore, it is preferable that an adhesive be used to fix the closed end of the tubular bag made of the mesh woven fabric 23 to the flexible printed wiring board 22 housed therein, and the opening of the tubular bag made of the mesh woven fabric 23 to the flexible printed wiring board 22 housed therein. For these fixations, thread, needles, etc. may be used instead of or in addition to the adhesive.

[0074] The width of the mesh-like woven fabric 23 formed in the elongated cylindrical shape is set so that when the balloon portion 21 is inflated with the flexible printed wiring board portion 22 and the balloon portion 21 integrated together, the mesh-like woven fabric 23 is pressed and fixed against the surface 21 d of the balloon portion 21. The length of the mesh-like woven fabric 23 formed in the elongated cylindrical shape is preferably a length that can accommodate the entire balloon portion 21 integrated with the flexible printed wiring board portion 22 when the balloon portion 21 is inflated. The length of the mesh-like woven fabric 23 formed in the elongated cylindrical shape is preferably approximately the same as the length of the balloon portion 21 in a deflated state, for example, so that the balloon portion 21 can be installed and retrieved without any problems when integrated with the flexible printed wiring board portion 22 and the balloon portion 21.

[0075] Examples of materials for the mesh fabric 23 include natural fibers such as cotton, linen, and silk; synthetic fibers such as polyethylene (PE), polypropylene (PP), nylon (PA), polyurethane (PU), polyethylene terephthalate (PET), and rayon; and composite fibers containing multiple types of fibers. The material for the mesh fabric 23 can be appropriately determined depending on the type and viscosity of liquid present in the living body, such as mucus such as secretions present at the position of the balloon portion 21 in the large intestine 5, and liquid contained in the contents of the large intestine 5. The mesh fabric 23 may be made of only one type of material, or two or more types of material.

[0076] Among the above materials, cotton is preferably used as the material for the mesh fabric 23. Cotton is a widely used material for absorbing mucus, such as secretions, and / or other liquids present in the body, and is stable and safe against alkaline mucus rich in bicarbonate ions produced in the large intestine 5 and liquids contained in the contents of the large intestine 5. Furthermore, using cotton as the material for the mesh fabric 23 increases the coefficient of friction against the large intestine wall 51 that is wetted with mucus, such as secretions, that are more viscous than water and / or liquids that are more viscous than water present in the body. Therefore, when the balloon portion 21 is placed in a position that is wetted with the above-mentioned liquids that are more viscous than water, cotton is particularly preferred as the material for the mesh fabric 23.

[0077] It is also preferable to use polyethylene (PE) as the material for the mesh fabric 23. By using polyethylene as the material for the mesh fabric 23, it is possible to increase the coefficient of friction against the large intestine wall 51 that is wetted with mucus, such as low-viscosity secretions with a viscosity similar to that of water, and / or a liquid with a viscosity similar to that of water present in the body. Therefore, when the balloon portion 21 is to be placed in a position that is wetted with the above-mentioned low-viscosity liquid with a viscosity similar to that of water, it is particularly preferable to use polyethylene as the material for the mesh fabric 23.

[0078] It is also preferable to use polyurethane (PU) and / or polyethylene terephthalate (PET) as the material for the mesh fabric 23.

[0079] The mesh fabric 23 used in this embodiment may be made of a single thread (fiber) or a bundle of multiple threads as the filament, which is a thread-like structure knitted or woven during production, but is preferably made of a bundle of multiple threads. This is because the mesh fabric 23 made by knitting or weaving a filament made of a bundle of multiple threads has a higher coefficient of friction against the wet colon wall 51 than the mesh fabric 23 made of a single filament.

[0080] The yarns forming the filaments used to manufacture the mesh fabric 23 may be made of only one type of fiber, or may be made of composite fibers containing multiple types of fibers.

[0081] The thickness of the yarn forming the filament is not particularly limited and can be determined appropriately depending on the number of yarns forming the filament, etc. Specifically, the thickness of the yarn forming the filament is preferably such that the filament has a thickness of 0.1 denier to 300 denier, and more preferably such that the filament has a thickness of 1 denier to 100 denier.

[0082] When the filament thickness is 0.1 denier or more, it is easy to obtain a mesh woven fabric 23 with sufficient strength. When the filament thickness is 300 denier or less, the mesh woven fabric 23 produced using the filaments does not become too thick. This prevents the mesh woven fabric 23 from interfering with the operation of placing and retrieving the mesh woven fabric 23, together with the flexible printed wiring board portion 22 and the balloon portion 21, in and from the large intestine 5, making it easy to place and retrieve the mesh woven fabric 23 in and from the large intestine 5.

[0083] The number of threads in a filament formed by bundling multiple threads is not particularly limited and can be determined appropriately depending on the thickness of the threads used in the filament, etc. The number of threads in a filament formed by bundling multiple threads can be, for example, 2 to 300, and preferably 50 to 150.

[0084] When the filament is formed by bundling a plurality of threads, the plurality of threads forming the filament may all be of the same type, or some or all of them may be of different types.

[0085] Examples of the shape of a filament formed by bundling multiple threads include those formed by twisting multiple threads together into a single thread. Examples of such filaments include those formed by bundling multiple threads together and twisting them in the same direction, those formed by bundling multiple threads twisted in the same direction together, and those formed by bundling multiple thread bundles formed by twisting multiple threads together in the same or different directions.

[0086] A preferred example of a filament formed by twisting multiple threads together into one is, for example, one that consists of one or more core materials made of a first fiber and one or more covering materials made of a second fiber of a different type from the first fiber that are spirally wound around the core material.

[0087] In such a filament, the first and second fibers are different in type, and therefore the properties of the filament can be changed by making the properties of the first and second fibers different from each other or by adjusting the thickness and number of the first and second fibers.

[0088] For example, a highly elastic fiber such as polyurethane (PU) can be used as the first fiber, and a highly absorbent fiber such as polyethylene terephthalate (PET) can be used as the second fiber. In this case, a synergistic effect can be achieved between the properties of the first fiber and the second fiber. That is, a filament can be obtained that has good absorbency due to the spirally wound second fiber and excellent elasticity due to the first fiber. A mesh-like woven fabric 23 manufactured using such a filament can easily conform to the shape of the inflated balloon portion 21 of the medical device 10 and efficiently absorb fluids present in the living body. As a result, the mesh-like woven fabric 23 tends to have a large contact area with the large intestine wall 51, resulting in a high coefficient of friction with the large intestine wall 51. As a result, the medical device 10 can be made such that the balloon portion 21 is even less likely to slip from its position within the large intestine 5.

[0089] Alternatively, for example, thick fibers may be used as the first fibers and thin fibers as the second fibers. In this case, good water absorption due to the capillary action of the spirally wound second fibers and large frictional force due to the uneven surface are obtained, and the thickness of the first fibers results in a filament with sufficient strength. The mesh-like woven fabric 23 manufactured using such filaments has sufficient strength and excellent water absorption, and a high coefficient of friction against the wet large intestine wall 51.

[0090] The mesh count of the mesh fabric 23 can be, for example, 2 to 200, and is preferably 30 to 200. In this embodiment, the mesh count of the mesh fabric 23 is a numerical value indicating the number of meshes present in a square of the mesh fabric 23, each side of which is 1 inch long. If the mesh fabric 23 has a count of 200 or less, the thickness of the mesh fabric 23 will not be too thin, and the mesh fabric 23 will have sufficient strength.

[0091] Furthermore, if the mesh fabric 23 has a count of 30 or higher, the mesh fabric 23 will not be too thick, and this will prevent the mesh fabric 23 from interfering with the operation of placing and retrieving the mesh fabric 23, together with the flexible printed wiring board 22 and the balloon 21, in and from the large intestine 5. Furthermore, if the mesh fabric 23 has a count of 100 or higher, the number of threads forming the mesh fabric 23 that is pressed against the large intestine wall 51 by the balloon 21 will be greater. As a result, the contact area between the mesh fabric 23 and the large intestine wall 51 will be larger, and the coefficient of friction of the balloon 21 against the large intestine wall 51 that is wetted with mucus such as secretions and / or liquids present in the body will tend to be higher.

[0092] The mesh size of the mesh fabric 23 can be, for example, 77 μm to 10.7 mm, and preferably 122 μm to 761 μm. When the mesh size of the mesh fabric 23 is 122 μm to 761 μm, the mesh fabric 23 is fixed to the surface 21d of the balloon portion 21, which tends to increase the coefficient of friction of the balloon portion 21 against the large intestine wall 51 that is moistened by mucus such as secretions and / or liquids present in the body. This makes it even more difficult for the balloon portion 21 to slip from its position within the large intestine 5.

[0093] More specifically, when the mesh size of the mesh fabric 23 is 122 μm to 761 μm, the surface 21d of the balloon portion 21 bites into the mesh of the mesh fabric 23 that is pressed against the large intestine wall 51 by the balloon portion 21, thereby firmly fixing the mesh fabric 23 to the surface 21d of the balloon portion 21 and closely adhering the large intestine wall 51 to the surface 21d of the balloon portion 21. Furthermore, as the surface 21d of the balloon portion 21 bites into the mesh of the mesh fabric 23, the surface 21d of the balloon portion 21 easily comes into direct contact with the large intestine wall 51, thereby increasing the contact area between the large intestine wall 51 and the mesh fabric 23 and the balloon portion 21. For these reasons, the coefficient of friction of the balloon portion 21 against the large intestine wall 51 that is wetted with mucus such as secretions and / or liquids present in the body tends to be high.

[0094] The weaving method of the mesh woven fabric 23 is not particularly limited, and for example, plain weave, twill weave, satin weave, or other woven fabrics can be used. Alternatively, a mesh-knitted fabric may be used as the mesh woven fabric 23. Known knitting methods that can be used to knit the mesh include, for example, pull-up knitting, smooth knitting (meliad knitting), pique knitting, reverse pique knitting, and tubular jersey. Among these, smooth knitting or pique knitting is preferred because they can be efficiently manufactured using a general knitting machine, and smooth knitting is most preferred because it tends to result in a high coefficient of friction of the balloon portion 21 against the large intestine wall 51.

[0095] Specifically, the mesh fabric 23 may be, for example, a plain weave fabric made of cotton, a plain weave fabric made of polyethylene, or a mesh-woven fabric made of polyurethane (PU) and / or polyethylene terephthalate (PET).

[0096] The mesh fabric 23 may be formed using a weave that provides elasticity. Alternatively, a material having elasticity may be used for the mesh fabric 23. In these cases, the mesh fabric 23 has elasticity. When the mesh fabric 23 is elastic, the mesh fabric 23 pressed against the surface 21d of the balloon portion 21 in an inflated state conforms to the shape of the balloon portion 21. This makes it easier for the inflated balloon portion 21 to press against the large intestine wall 51 along the inner surface shape of the large intestine wall 51, which has irregularities, which is preferable. Furthermore, because the mesh fabric 23 conforms to the shape of the balloon portion 21, the contact area between the large intestine wall 51 and the mesh fabric 23 and the balloon portion 21 increases, making it even more difficult for the balloon portion 21 to slip from its position within the large intestine 5.

[0097] In this embodiment, an example will be described in which there is only one mesh woven fabric 23, but the number of mesh woven fabrics 23 is not limited to one, and may be two, three, or four or more. The number of mesh woven fabrics 23 can be determined depending on the material, count, mesh size, weave, etc. of the mesh woven fabric 23.

[0098] 1(a), the connection part 31 electrically connects the metal wiring 22d of the flexible printed circuit board (FPC) part 22 integrated with the balloon part 21 to the conductive cable 32 electrically connected to a power source and various devices provided outside the living body. A known wiring connection device can be used as the connection part 31. Furthermore, the conductive cable 32 can be any flexible conductive cable, such as a known flexible flat cable.

[0099] [Fluid supply / discharge tube 33] The fluid supply / discharge tube 33 is used to supply and discharge fluid into and from the balloon portion 21. As shown in Fig. 1(a), the fluid supply / discharge tube 33 is connected to a position near the connection portion 31 of the balloon portion 21 by a known method. The end of the fluid supply / discharge tube 33 opposite the balloon portion 21 is provided outside the living body. A known control device that can control the supply and discharge of fluid to and from the balloon portion 21 is connected to the end of the fluid supply / discharge tube 33 opposite the balloon portion 21.

[0100] The fluid supplied into the balloon 21 from the fluid supply / discharge tube 33 may be a liquid such as water or saline, or a gas such as air or nitrogen, but it is preferable to use air because it is easy to manage and low cost.

[0101] A flexible tube can be used as the fluid supply / discharge tube 33. Examples of the fluid supply / discharge tube 33 include a silicone resin tube and a polyethylene resin tube.

[0102] [Method of Manufacturing Medical Device 10] Next, an example of a method of manufacturing the medical device 10 of this embodiment will be described. The method of manufacturing the medical device 10 of this embodiment includes a balloon portion 21 forming step, a flexible printed wiring board portion 22 forming step, a mesh woven fabric 23 providing step, a forming step, and an assembly step.

[0103] [Balloon portion 21 forming process] In the balloon portion 21 forming process, first, a strip-shaped resin sheet 21a is prepared to become the balloon portion 21. Next, a strip-shaped glassine paper 21b is placed in a predetermined position on the resin sheet 21a along the length direction of the resin sheet 21a, and the glassine paper 21b is bonded to the resin sheet 21a using a known adhesive to form a bonding layer 21e.

[0104] The strip-shaped resin sheet 21a is then folded in three widthwise so that the side of the resin sheet 21a to which the glassine paper 21b is bonded faces inward. The two widthwise ends of the resin sheet 21a, which has been folded in three and overlapped, are then bonded together using a known adhesive to form a bonding layer 21c. Furthermore, the resin sheet 21a folded in three is then bonded at both longitudinal ends of the balloon portion 21 using a known adhesive to form a bonding layer (not shown). This results in the formation of a sealed, tubular balloon portion 21 that is approximately elliptical in cross section when the balloon portion 21 is inflated.

[0105] In the flexible printed wiring board portion 22 forming process, first, a wiring layer 22b including a plurality of metal wires 22d having a predetermined planar shape and an insulating layer 22g is laminated on the entire surface of one of the strip-shaped liquid crystal polymer layers 22c by a known method, thereby forming a laminate having a strip-shaped region extending in a strip shape in a planar view and a connection region extending from one end of the strip-shaped region in a direction intersecting the longitudinal direction.

[0106] A strip-shaped resin sheet 22a is also prepared. A superelastic alloy wire 22e is then placed along the widthwise center of the resin sheet 22a, and a strip-shaped region of a laminate, in which a wiring layer 22b and a liquid crystal polymer layer 22c are stacked, is placed between the superelastic alloy wire 22e and one side surface. Next, the resin sheet 22a is folded in half along the widthwise center so as to sandwich the strip-shaped region of the laminate and the superelastic alloy wire 22e. The folded resin sheets 22a are then bonded together along the edges of the resin sheets 22a using a known adhesive to form a bonding layer 22f. Through these steps, a flexible printed wiring board portion 22 is formed, in which the connection region of the laminate is exposed from the resin sheet 22a forming one end.

[0107] Then, as shown in Figures 1(a) and 1(b), the flexible printed wiring board portion 22 is placed opposite the area on the surface 21d of the balloon portion 21 where both widthwise ends of the strip-shaped resin sheet 21a are overlapped, and is bonded to the balloon portion 21 using a known adhesive to form an integrated body.

[0108] [Process for Setting Mesh Woven Fabric 23] In the process for setting mesh woven fabric 23, a strip of mesh woven fabric 23 is folded in half and glued along edge 23a to prepare a long, tubular bag with one end closed. In this embodiment, instead of or in addition to gluing edge 23a of the folded strip of mesh woven fabric 23, it may be sewn using thread, needles, or the like. In this embodiment, when suturing mesh woven fabric 23 with a needle, for example, a needle used for staples in an automatic surgical stapler or the like may be used.

[0109] Next, the balloon portion 21 integrated with the flexible printed wiring board portion 22 is housed in a long, thin, cylindrical bag with one end closed and made of mesh woven fabric 23. At this time, the bag is housed so that the connection area exposed from the resin sheet 22a forming the flexible printed wiring board portion 22 protrudes from the opening outside the bag made of mesh woven fabric 23.

[0110] Thereafter, the bag made of mesh woven fabric 23 is placed over balloon portion 21 integrated with flexible printed wiring board portion 22, and a known adhesive is used to fix between the closed end of the bag made of mesh woven fabric 23 and flexible printed wiring board portion 22 housed therein, and between the opening of the bag made of mesh woven fabric 23 and flexible printed wiring board portion 22 housed therein. In this embodiment, instead of or in addition to using an adhesive to fix between the closed end of the bag made of mesh woven fabric 23 and flexible printed wiring board portion 22 housed therein, and between the opening of the bag made of mesh woven fabric 23 and flexible printed wiring board portion 22 housed therein, they may be fixed by sewing with thread, needle, or the like.

[0111] [Forming Process] In the forming process, the balloon portion 21 is formed into a predetermined spiral shape when a fluid is supplied into the balloon portion 21. Specifically, for example, the balloon portion 21, which is housed in a long, thin cylindrical bag made of mesh woven fabric 23 and integrated with the flexible printed wiring board portion 22, is wound around a cylindrical mold with the flexible printed wiring board portion 22 facing inward to form the predetermined spiral shape. In this state, a heat treatment can be performed, for example, at a temperature of 140°C to 160°C for 30 to 40 minutes.

[0112] After the forming step, the metal wiring 22d arranged in the connection area exposed from the resin sheet 22a forming the flexible printed wiring board 22 is electrically connected to the terminal of the connection portion 31 by a known method such as soldering. The connection portion 31 is also electrically connected to the conductive cable 32 by a known method.

[0113] Furthermore, a fluid supply / discharge tube 33 is connected by a known method to a position near the connecting portion 31 of the balloon portion 21. The fluid supply / discharge tube 33 may be connected by a known method to a predetermined position of the balloon portion 21 in the balloon portion 21 formation step. Through the above steps, the medical device 10 of this embodiment can be manufactured.

[0114] [Method of Use] Next, an example of a method of using the medical instrument 10 of this embodiment will be described. In this embodiment, as an example of a preferred method of using the medical instrument 10 of this embodiment, a case where the medical instrument 10 of this embodiment is used as a medical balloon used when performing a colon examination and / or colonoscopic surgery using an endoscope and a medical balloon will be described.

[0115] When the medical device 10 of this embodiment is used for the above-mentioned purposes, it is preferable that the medical device 10 of this embodiment be installed in the large intestine 5 together with a device that can be used in cooperation with an endoscope. Preferred devices that can be used in cooperation with an endoscope include function-added devices having one or more functions selected from "observation," "traction," and "medicinal solution release / sampling." The medical device 10 of this embodiment can be suitably used as a scaffold for fixing these function-added devices to predetermined positions in the large intestine 5. Specifically, it is preferable that one or more of the above-mentioned function-added devices be installed on the surface of the flexible printed wiring board portion 22 of the medical device 10 of this embodiment opposite the balloon portion 21 (the underside in FIG. 1( b )), and electrically connected to the metal wiring 22 d.

[0116] Examples of functional devices having an observation function include an imaging element, a lighting device, etc. When an imaging element is used as a functional device, the inside of the large intestine 5 can be observed from multiple angles compared to observing the inside of the large intestine 5 using only an endoscope. Furthermore, the position of the imaging element within the large intestine 5 is fixed by the medical instrument 10 installed as a scaffold, so the observation field of the imaging element within the large intestine 5 does not move as the endoscope moves, and the inside of the large intestine 5 can be observed easily and stably.

[0117] An example of a function-added device having a towing function is a towing clip, etc. Furthermore, an example of a function-added device having a chemical solution release / sampling function is a device that incorporates a container for storing the chemical solution, a sampling brush, a container for storing the sampling brush, etc.

[0118] When the medical instrument 10 of this embodiment is used together with an endoscope and a function-adding device that uses the medical instrument 10 of this embodiment as a scaffold, it can be used, for example, in the following manner. First, the function-adding device is placed on the surface of the flexible printed wiring board part 22 integrated with the balloon part 21, opposite the balloon part 21, via the mesh woven fabric 23. At this time, the function-adding device and the metal wiring 22d of the flexible printed wiring board part 22 are electrically connected by a known method. This makes it possible to supply power to the function-adding device via the medical instrument 10 of this embodiment.

[0119] Next, an overtube is placed over the endoscope, and the endoscope is inserted from the anus to a predetermined position within the large intestine 5. Thereafter, only the endoscope is pulled out from the large intestine 5, and the overtube is left in place within the large intestine 5. As the endoscope, for example, a known endoscope equipped with forceps that is used for examination and / or surgery of the large intestine 5 can be used.

[0120] The overtube used has an inner diameter that allows the balloon portion 21 in a deflated state and the flexible printed wiring board portion 22, which is integrated with the balloon portion 21 and on which a function-adding device is installed, to pass through in a thinly wound state. As the overtube, for example, a known one having an inner diameter of 10 mm to 14 mm and used when inserting and removing an endoscope into and from the large intestine 5 can be used.

[0121] Next, the deflated balloon portion 21 and the flexible printed wiring board portion 22, which is integrated with the balloon portion 21 and on which the function-adding device is installed, are wound thinly. Then, while one end of the conductive cable 32 and one end of the fluid supply / discharge tube 33 are kept positioned outside the body, the balloon portion 21, the flexible printed wiring board portion 22, the function-adding device, and the connection portion 31 are placed inside the overtube.

[0122] Thereafter, the endoscope is inserted into the overtube and pushed in, thereby pushing the balloon section 21, the flexible printed wiring board section 22, the function-adding device, and the connection section 31 to a predetermined position in the large intestine 5. When pushing the endoscope into the overtube, a known protection device for protecting the endoscope may be attached to the tip of the endoscope.

[0123] Next, fluid is supplied into the balloon portion 21 via the fluid supply / discharge tube 33. The fluid supplied into the balloon portion 21 inflates the balloon portion 21, forming the balloon portion 21 into a spiral shape, and pressing the balloon portion 21 outward from the central axis of the spiral shape approximately evenly against the wall 51 of the large intestine 5 (see FIG. 2). As a result, the balloon portion 21 is fixed at a predetermined position within the large intestine 5, and the function-adding device mounted on the flexible printed wiring board 22 integrated with the balloon portion 21 is fixed at a predetermined position.

[0124] The amount of fluid supplied into the balloon portion 21 is determined appropriately depending on the thickness of the resin sheet 21a forming the balloon portion 21 when it is in a deflated state, the hardness of the resin sheet 21a measured with a Type A durometer, the length of the balloon portion 21 when it is in a deflated state, and the thickness of the balloon portion 21.

[0125] Next, a predetermined colon examination and / or colon endoscopic surgery is performed using the endoscope and the function-adding device. In this embodiment, the medical instrument 10 of this embodiment is used as a scaffold for the function-adding device, and the balloon portion 21 is less likely to shift from its position in the large intestine 5. Therefore, in this embodiment, the function-adding device is easily maintained in a predetermined position in the large intestine 5, and the operability, accuracy, and stability of the intended treatment, such as the colon examination and / or surgery, are improved.

[0126] Thereafter, the fluid is discharged from inside the balloon portion 21 via the fluid supply / discharge tube 33, causing the balloon portion 21 to deflate. Then, using forceps provided on the endoscope, the balloon portion 21, the flexible printed wiring board portion 22, the function-adding device, and the connection portion 31 are taken into the overtube and removed together with the endoscope to the outside of the body through the overtube. Thereafter, the overtube is removed to the outside of the body.

[0127] The medical device 10 of this embodiment is a medical device including a balloon portion 21, which is a pressing portion that is placed in contact with tissues and organs in the large intestine 5 and presses against the tissues and organs, and a mesh-like woven fabric 23 is fixed to the surface 21d of the balloon portion 21. The balloon portion 21, which has the mesh-like woven fabric 23 fixed to the surface 21d, has a high coefficient of friction with tissues and organs in the large intestine 5 that are wetted with mucus such as secretions and / or other liquids present in the large intestine 5. As a result, the medical device 10 of this embodiment is less likely to shift from its position in the large intestine 5 and is more likely to remain positioned in a predetermined position in the large intestine 5. Therefore, with the medical device 10 of this embodiment, it is not necessary to apply a strong pressing force of the medical device 10 against tissues and organs to prevent the medical device 10 from shifting position after being placed in a living body, and the load on the tissues and organs due to the pressing force of the medical device 10 can be reduced.

[0128] (Other Examples) In the medical device 10 of this embodiment, an example has been described in which the device includes the flexible printed circuit board (FPC) portion 22, the connection portion 31, and the conductive cable 32. However, the flexible printed circuit board (FPC) portion 22, the connection portion 31, and the conductive cable 32 may be provided as needed and may not be provided.

[0129] In the medical device 10 of this embodiment, the balloon portion 21 is tubular, and when a fluid is supplied into the balloon portion 21, it is formed into a spiral shape, and the spiral shape is pressed outward from the central axis of the spiral shape. However, the shape of the balloon portion 21 is not particularly limited. For example, the balloon portion may be expanded by supplying a fluid and formed into a spherical or cylindrical shape.

[0130] Furthermore, in the medical device 10 of this embodiment, the balloon portion 21 is placed in the large intestine, but the medical device of the present invention may be placed in other organs, such as the digestive tract, including the small intestine. Furthermore, in the medical device 10 of this embodiment, the pressing portion is the balloon portion 21 that can be expanded and contracted, but the pressing portion in the medical device of the present invention does not have to be a balloon portion as long as it has a mesh woven fabric fixed to its surface.

[0131] Furthermore, in the medical device 10 of this embodiment, as shown in FIG. 1(b), a band-shaped resin sheet 21a is folded in three widthwise directions, and both overlapping widthwise ends of the resin sheet 21a are joined by a joining layer 21c, thereby providing a ring-shaped balloon portion 21. However, the shape of the balloon portion 21 is not limited to the example shown in FIG. 1(b).

[0132] 9 is a schematic cross-sectional view illustrating another example of the balloon portion 210 provided in the medical device of this embodiment. As shown in Fig. 9, in the medical device of this embodiment, the strip-shaped resin sheet 21a forming the balloon portion 210 may be formed into a ring shape by butting together the side surfaces of the resin sheets 21a at approximately the center in the width direction so that they face each other.

[0133] The balloon portion 210 shown in Fig. 9 differs from the balloon portion 21 shown in Fig. 1(b) only in the joining structure of the widthwise edge portions of the resin sheet 21a. Therefore, in the balloon portion 210 shown in Fig. 9, the same members as those in the balloon portion 21 shown in Fig. 1(b) are denoted by the same reference numerals, and descriptions thereof will be omitted.

[0134] 9, widthwise side surfaces of the strip-shaped resin sheet 21a are butted against each other so as to face each other, and glassine paper 21b is bonded to an inner surface region including the portion where the widthwise side surfaces of the resin sheet 21a are butted against each other (in other words, both widthwise edge portions on one surface of the resin sheet 21a) by bonding layers 21c and 21e.

[0135] 9 , an outer surface region including a portion where widthwise side surfaces of the strip-shaped resin sheet 21a are butted against each other so as to face each other (in other words, both widthwise edge portions on the other surface of the resin sheet 21a) is disposed opposite the flexible printed wiring board portion 22. The outer surface region including the portion where the widthwise side surfaces of the strip-shaped resin sheet 21a are butted against each other is bonded to the flexible printed wiring board portion 22 by a bonding layer 21f, thereby integrating the flexible printed wiring board portion 22 and the balloon portion 21.

[0136] The balloon portion 210 shown in Fig. 9 can be manufactured, for example, by the method described below. Figs. 10 to 12 are explanatory views for describing a method for manufacturing a medical device 10 having the balloon portion 210 shown in Fig. 9. In the method for manufacturing a medical device 10 having the balloon portion 210 shown in Fig. 9, the same steps as those in the method for manufacturing a medical device 10 having the balloon portion 21 shown in Fig. 1(b) will not be described.

[0137] Figures 10(a) and 11(a) are plan views showing a part of the process for manufacturing the balloon portion 210 shown in Figure 9. Figure 10(b) is a schematic cross-sectional view taken along line BB' shown in Figure 10(a). Figure 11(b) is a schematic cross-sectional view taken along line CC' shown in Figure 11(a).

[0138] To manufacture the balloon portion 210 shown in FIG. 9 , first, a strip-shaped resin sheet 21a that will become the balloon portion 210 is prepared. Also, a strip-shaped glassine paper 21b is prepared and folded in half along the widthwise center 21h as shown in FIG. 10( b). Next, as shown in FIGS. 10( a) and 10(b), bonding layers 21c and 21e are formed on both outer surfaces of the folded glassine paper 21b using a known adhesive. Next, the widthwise center 21h of the strip-shaped glassine paper 21b is positioned along the widthwise edge of one surface of the resin sheet 21a, and the glassine paper 21b and the resin sheet 21a are bonded together by the bonding layer 21e.

[0139] 11(a) and 11(b), the strip-shaped resin sheet 21a is folded in half along the widthwise center 21g, and a bonding layer 21c provided on the outer surface of the folded glassine paper 21b is bonded to one side of the resin sheet 21a. Next, the folded glassine paper 21b is opened so that the widthwise edges are spaced apart, and as shown in FIG. 12, the widthwise center 21h of the glassine paper 21b (see FIG. 11(b)) and the widthwise center 21g of the folded resin sheet 21a are brought closer to each other, and the folded glassine paper 21b is returned to a flat state (see FIG. 12).

[0140] As a result, the sides of the resin sheets 21a are butted together so that they face each other, as shown in Fig. 12. Thereafter, the resin sheets 21a, with their widthwise sides butted together so that they face each other, are bonded at both longitudinal ends of the balloon portion 210 using a known adhesive to form bonding layers (not shown). As a result, a sealed, tubular balloon portion 210 is formed that has a substantially elliptical cross-sectional shape when viewed in an inflated state.

[0141] 9, the flexible printed wiring board 22 is placed opposite an outer surface region of the surface 21d of the balloon portion 210, including the portion where the widthwise side surfaces of the strip-shaped resin sheets 21a are butted against each other, and is bonded and integrated with the balloon portion 210 using a known adhesive. The medical device 10 having the balloon portion 210 shown in FIG. 9 can be manufactured by performing other steps similar to those in the manufacturing method for the medical device 10 having the balloon portion 21 shown in FIG.

[0142] Similar to the method for manufacturing the medical device 10 having the balloon portion 210 shown in FIG. 1(b), the medical device 10 having the balloon portion 210 shown in FIG. 9 is also less likely to shift from its position within the large intestine 5, and is more likely to remain installed at a predetermined position within the large intestine 5.

[0143] Furthermore, the medical device 10 having the balloon portion 210 shown in Fig. 9 has only one layer of resin sheet 21a disposed between the flexible printed wiring board portion 22 and the glassine paper 21b. In contrast, the medical device 10 having the balloon portion 21 shown in Fig. 1(b) has two layers of resin sheet 21a disposed between the flexible printed wiring board portion 22 and the glassine paper 21b. Therefore, the medical device 10 having the balloon portion 210 shown in Fig. 9 has a thinner balloon portion 210 in a deflated state than the medical device 10 having the balloon portion 21 shown in Fig. 1(b), making it easier to place and retrieve the balloon portion 210 in the large intestine 5.

[0144] Furthermore, the medical device 10 having the balloon portion 210 shown in Figure 9 can be manufactured using a method in which the widthwise center 21h of the strip-shaped glassine paper 21b is positioned along the widthwise edge of one surface of the resin sheet 21a, the glassine paper 21b and the resin sheet 21a are joined together with a joining layer 21e, the strip-shaped resin sheet 21a is folded in half along the widthwise center 21g, the joining layer 21c provided on the outer surface of the folded glassine paper 21b is joined to one surface of the resin sheet 21a, the folded glassine paper 21b is opened so that the distance between the widthwise edges is increased, and the distance between the widthwise center 21h of the glassine paper 21b and the widthwise center 21g of the folded resin sheet 21a is reduced, thereby returning the folded glassine paper 21b to a flat state. Therefore, compared to the medical device 10 having the balloon portion 21 shown in FIG. 1(b), the medical device 10 having the balloon portion 210 shown in FIG. 9 is easier to align when joining the edges of the resin sheet 21a and when joining the glassine paper 21b and the resin sheet 21a, and can be manufactured easily and accurately with fewer steps.

[0145] 3 is a perspective view illustrating a medical instrument according to a second embodiment. As shown in FIG. 3 , a medical instrument 60 of this embodiment has a rod-shaped shaft 62, a pressing part 61 provided at a first end of the shaft 62, a mesh-like woven fabric 63 fixed to the surface of the pressing part 61, and a handle 64 provided at a second end of the shaft 62.

[0146] The pressing portion 61 of the medical instrument 60 of this embodiment is placed in contact with organs such as the liver, gallbladder, and lungs in a living body and tissues in the vicinity thereof to press against the tissues and organs. Therefore, the medical instrument 60 of this embodiment is an exclusion forceps (exclusion instrument) that uses the pressing portion 61 to exclude tissues and organs.

[0147] The pressing portion 61 is made of a metal such as stainless steel. The pressing portion 61 has a generally cylindrical rod shape with a generally uniform thickness and curved at a predetermined angle. In this embodiment, the pressing portion 61 will be described using the shape shown in Fig. 3 as an example, but the shape of the pressing portion in the medical device of this embodiment is not limited to the shape shown in Fig. 3.

[0148] For example, the thickness of the pressing portion does not have to be approximately uniform, and may have thick and thin portions. When the pressing portion has thick and thin portions, the thickness of the pressing portion may gradually change, or may change by providing a step. Furthermore, the pressing portion does not have to be curved, and may have a linear shape extending in the first direction. Furthermore, the cross-sectional shape of the pressing portion is not limited to being approximately circular, and may be approximately elliptical, approximately oval, or approximately polygonal. Furthermore, the pressing portion does not have to be rod-shaped, and may be, for example, plate-shaped. When the pressing portion is plate-shaped, the planar shape and cross-sectional shape of the plate-shaped pressing portion are not particularly limited. Furthermore, the pressing portion 61 may be flexible and deformable into any shape.

[0149] Similar to the mesh woven fabric 23 in the first embodiment, a long, thin cylindrical bag with one end closed can be used as the mesh woven fabric 63. The pressing part 61 is inserted into the cylindrical bag with one end closed made of the mesh woven fabric 63 until the tip of the pressing part 61 reaches the end.

[0150] The mesh woven fabric 23 is fixed to the pressing portion 61 using one or more materials selected from an adhesive, thread, and metal wire. The mesh woven fabric 23 may be fixed continuously from one end to the other end in the longitudinal direction around part or all of the circumferential direction of the pressing portion 61 using an adhesive, for example. The mesh woven fabric 23 may also be fixed at one location along the longitudinal direction of the pressing portion 61 or at multiple locations spaced apart at predetermined intervals, for example, by wrapping thread and / or metal wire around and tying the mesh woven fabric 23. The material, count, mesh size, and weaving method of the mesh woven fabric 63 may be the same as those used for the mesh woven fabric 23 in the first embodiment.

[0151] The shaft 62 is a rigid rod-like member made of a metal such as stainless steel, and the handle 64 may be made of a known resin.

[0152] The medical device 60 of this embodiment can be manufactured, for example, by the following method. First, a rod-shaped shaft 62 is prepared, and a rod-shaped pressing portion 61 is joined to a first end of the shaft 62 by a known method. Next, the pressing portion 61 is inserted into a bag made of a tubular mesh woven fabric 63 with one end closed, and the tip of the pressing portion 61 reaches the end of the tubular bag with one end closed, covering the pressing portion 61 with the mesh woven fabric 63. Thereafter, the mesh woven fabric 63 is fixed to the pressing portion 61 using one or more materials selected from adhesive, thread, and metal wire. Then, a handle 64 is attached to the second end of the shaft 62. The medical device 60 of this embodiment is obtained through the above steps.

[0153] The medical instrument 60 of this embodiment includes a pressing portion 61 that is placed in contact with tissues and organs in a living body and presses against the tissues and organs. A mesh-like woven fabric 63 is fixed to the surface of the pressing portion 61. The pressing portion 61, having the mesh-like woven fabric 63 fixed to its surface, has a high coefficient of friction with tissues and organs in a living body that are wetted with mucus, such as secretions, and / or other liquids present in the living body. Therefore, the medical instrument 60 of this embodiment is less likely to shift from its position in the living body and is more likely to remain in a predetermined position in the living body. Therefore, with the medical instrument 60 of this embodiment, it is not necessary to apply a strong pressing force to the tissues and organs to prevent the medical instrument 60 from shifting position after being placed in the living body, and the load caused by the pressing force of the medical instrument 60 on the tissues and organs can be reduced. Therefore, the medical instrument 60 of this embodiment can be preferably used as an exclusion instrument that excludes tissues and organs using the pressing portion 61.

[0154] In contrast, even if the pressing portion 61 is inserted into a cylindrical bag made of mesh fabric 63 with one end closed until the tip of the pressing portion 61 reaches the end of the bag, it is difficult to maintain the medical instrument in a predetermined position within the living body unless the mesh fabric 63 is fixed to the surface of the pressing portion 61. This is because, if the mesh fabric 63 is not fixed, when the tissues and organs within the living body become moist due to mucus such as secretions and / or other liquids present within the living body, the mesh fabric 63 becomes slippery on the surfaces of the tissues and organs within the living body. As a result, even if the medical instrument is pressed against the tissues and organs within the living body, sufficient friction cannot be applied, and the medical instrument is likely to slip from its position within the living body.

[0155] In the medical devices 10 and 60 of the first and second embodiments described above, the mesh woven fabric 23 is fixed to the surface of the pressing portion as a frictional force imparting sheet, but the frictional force imparting sheet is not limited to mesh woven fabric as long as it is a sheet-like material that can impart frictional force to the pressing portion by being fixed to the surface of the pressing portion and can be fixed along the surface shape of the pressing portion. Examples of frictional force imparting sheets that are not mesh woven fabric include nonwoven fabric, foam sheet, paper, metal mesh, and array-like structures with holes.

[0156] Although the preferred embodiments of the present invention have been described in detail above, the present invention is not limited to the specific embodiments, and various modifications and changes are possible within the scope of the gist of the present invention as set forth in the claims.

[0157] Example 1: A test piece for Example 1 was obtained by simulating the pressing portion of a medical instrument using the following method. First, a roughly rectangular parallelepiped artificial skin piece (tactile contact: finger model, manufactured by Trinity Lab Co., Ltd.) measuring 15 mm in length, 32 mm in width, and 8.0 mm in thickness was prepared. Next, a silicone resin sheet (Sirius ultra-thin silicone resin rubber (transparent) hardness 20, manufactured by Fuso Rubber Industries Co., Ltd.) with a thickness of 200 μm and a hardness of 20° measured with a Type A durometer was attached to the surface of the artificial skin piece. Subsequently, a sheet of medical gauze (FC gauze, #30, wire diameter 300 μm, mesh size 7700 μm, cotton, manufactured by Hakujuji Co., Ltd.) was wrapped around the silicone resin sheet as a mesh-like woven fabric and fixed to the silicone resin sheet using double-sided tape (trade name: Nicetack Super Strong NW-U15, manufactured by Nichiban Co., Ltd.). This resulted in a test piece for Example 1.

[0158] Furthermore, a sample was prepared as a large intestine model made of a self-healing polymer gel (Wizard Gel, manufactured by Yushiro Chemical Industry Co., Ltd.) containing 0.1% by mass of polyethylene glycol diacrylate 575 (manufactured by Merck) to simulate in vivo tissue. Using a friction tester (multifunctional static and dynamic friction measuring instrument TL201Tt, manufactured by Trinity Lab Co., Ltd.), the coefficient of friction of the test piece of Example 1 against a sample wetted with water as a liquid was measured by the following method.

[0159] [Method of Measuring Friction Coefficient] FIG. 4 is a side view illustrating a friction test apparatus. In FIG. 4, reference numeral 70 denotes the friction test apparatus. As shown in FIG. 4, a test piece 75 was placed facing downward in the friction test apparatus 70. A container 71 with a sample 73 attached thereto was fixed to a stage 74 of the friction test apparatus 70. The sample 73 was wetted by immersing it in a liquid 72. Then, the test piece 75 was pressed against the liquid-wetted sample 73 with a vertical load as shown below. The test piece 75 was then moved horizontally 20.0 mm at a sliding velocity as shown below. The friction coefficient of the test piece 75 relative to the sample 73 was measured five times, and the average value was calculated. The measurement conditions are as follows:

[0160] [Measurement conditions] Vertical load: 0.098 N Temperature: 20°C ± 5°C Sliding speed: 1 mm / sec, 10 mm / sec, 50 mm / sec, 100 mm / sec Sliding distance: 30.0 mm

[0161] Comparative Example 1 A test piece for Comparative Example 1 was obtained by attaching the same silicone resin sheet as in Example 1 to a piece of artificial skin as in Example 1. The coefficient of friction of the test piece for Comparative Example 1 was then measured in the same manner as for the test piece for Example 1.

[0162] The ratio of the measured friction coefficient of the test piece of Example 1 to the measured friction coefficient of the test piece of Comparative Example 1 (friction coefficient of Example 1 / friction coefficient of Comparative Example 1) was calculated. The results are shown in Table 1.

[0163]

[0164] Example 2 The coefficient of friction of the test piece of Example 1 was measured in the same manner as in Example 1, except that 90% by mass of glycerol (viscosity 200 mPa s) was used as the liquid 72 in which the sample 73 shown in Fig. 4 was immersed, and the ratio of the coefficient of friction to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 2.

[0165]

[0166] Example 3 A test piece for Example 3 was obtained in the same manner as in Example 1, except that three layers of medical gauze were wrapped around the test piece as the mesh fabric. The coefficient of friction of the test piece for Example 3 was measured in the same manner as in Example 1, and the ratio of this coefficient to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 3.

[0167]

[0168] Example 4 The coefficient of friction of the test piece of Example 3 was measured in the same manner as in Example 3, except that 90% by mass of glycerol was used as the liquid 72 in which the sample 73 shown in Fig. 4 was immersed, and the ratio of the coefficient of friction to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 4.

[0169]

[0170] Example 5 A test piece for Example 5 was obtained in the same manner as in Example 1, except that one mesh sheet (#30, wire diameter 299 μm, mesh size 761 μm, manufactured by AS ONE Corporation) made of polyethylene (PE) was used as the mesh-like woven fabric. The coefficient of friction of the test piece for Example 5 was measured in the same manner as for the test piece for Example 1, and the ratio to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as for Example 1. The results are shown in Table 5.

[0171]

[0172] Example 6 The coefficient of friction of the test piece of Example 5 was measured in the same manner as in Example 5, except that 90% by mass of glycerol was used as the liquid 72 in which the sample 73 shown in Fig. 4 was immersed, and the ratio of the coefficient of friction to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 6.

[0173]

[0174] Example 7 A test piece for Example 7 was obtained in the same manner as in Example 5, except that three mesh sheets made of polyethylene (PE) were wound around the test piece as the mesh-like woven fabric. The coefficient of friction of the test piece for Example 7 was measured in the same manner as in Example 1, and the ratio of this coefficient to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 7.

[0175]

[0176] Example 8 The coefficient of friction of the test piece of Example 7 was measured in the same manner as in Example 7, except that 90 mass % glycerol was used as the liquid 72 in which the sample 73 shown in Fig. 4 was immersed, and the ratio of the coefficient of friction to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 8.

[0177]

[0178] Example 9 A test piece for Example 9 was obtained in the same manner as in Example 1, except that one mesh sheet (#200, wire diameter 86 μm, mesh size 122 μm, manufactured by AS ONE Corporation) made of polyethylene (PE) was used as the mesh-like woven fabric. The coefficient of friction of the test piece for Example 9 was measured in the same manner as for the test piece for Example 1, and the ratio to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as for Example 1. The results are shown in Table 9.

[0179]

[0180] Example 10 The coefficient of friction of the test piece of Example 9 was measured in the same manner as in Example 9, except that 90% by mass of glycerol was used as the liquid 72 in which the sample 73 shown in Fig. 4 was immersed, and the ratio of the coefficient of friction to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 10.

[0181]

[0182] Example 11 A test piece for Example 11 was obtained in the same manner as in Example 9, except that three mesh sheets made of polyethylene (PE) were wound around the test piece as the mesh-like woven fabric. The coefficient of friction of the test piece for Example 11 was measured in the same manner as in Example 1, and the ratio of the coefficient of friction to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 11.

[0183]

[0184] Example 12 The coefficient of friction of the test piece of Example 11 was measured in the same manner as in Example 11, except that 90% by mass of glycerol was used as the liquid 72 in which the sample 73 shown in Fig. 4 was immersed, and the ratio of the coefficient of friction to the measurement result of the coefficient of friction of Comparative Example 1 was calculated in the same manner as in Example 1. The results are shown in Table 12.

[0185]

[0186] As shown in Tables 1 to 12, Examples 1 to 12, which used test specimens in which a mesh woven fabric was fixed to the surface of a silicone resin sheet, tended to have higher coefficients of friction compared to Comparative Example 1, in which no mesh woven fabric was wrapped around the surface of the silicone resin sheet. Also, as shown in Tables 1 to 4, Examples 1 to 4, which used cotton medical gauze as the mesh woven fabric, showed a significant tendency for the coefficient of friction to increase when a highly viscous 90% by mass glycerol (viscosity 200 mPa s) was used as liquid 72 in which sample 73 shown in FIG. 4 was immersed.

[0187] Furthermore, as shown in Tables 5 to 12, in Examples 5 to 12 in which a mesh sheet made of polyethylene (PE) was used as the mesh woven fabric, there was a significant tendency for the coefficient of friction to increase when water was used as the liquid 72 in which sample 73 shown in Fig. 4 was immersed. In particular, in Examples 9 to 12 in which a mesh sheet (#200) made of polyethylene (PE) was used as the mesh woven fabric, there was a significant tendency for the coefficient of friction to increase when water was used as the liquid 72 in which sample 73 shown in Fig. 4 was immersed.

[0188] Furthermore, in Examples 9 to 12, in which a mesh sheet (#200) made of polyethylene (PE) was used as the mesh fabric, the friction coefficient tended to be higher when one mesh sheet was used (Examples 9 and 10) compared to when three mesh sheets were stacked (Examples 11 and 12), regardless of whether water was used as the liquid (Examples 9 and 11) or whether 90% by mass of glycerol was used (Examples 10 and 12).

[0189] The reason for this is presumably that by stacking three mesh sheets, some of the holes in each mesh sheet were filled with the threads forming the other mesh sheets stacked on top of it. As a result, in the test piece with three stacked mesh sheets fixed, there was less room for the liquid 72 sandwiched between the silicone resin sheet and the sample to escape, and it is thought that the effect of fixing the mesh sheet to the surface of the silicone resin sheet to improve the friction coefficient was not sufficiently achieved.

[0190] Example 13 As the sample 73 shown in FIG. 4 , a sample made of polyvinyl alcohol (PVA) hydrogel (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.; polyvinyl alcohol 1000; fully saponified type) measuring 50 mm in length, 90 mm in width, and 10 mm in thickness was prepared, and the sample 73 was placed so that the horizontal direction thereof coincided with the direction of movement of the test piece 75.

[0191] Then, the same test piece 75 as in Example 1 was pressed against the sample 73 with the following vertical loads, and the test piece 75 was moved in the horizontal direction at the following sliding speeds and sliding distances. Except for this, the coefficient of friction of the test piece 75 of Example 1 against the sample 73, which had been wetted with water as the liquid 72, was measured in the same manner as in Example 1, and the average value was calculated when the sliding distance was in the range of 10.0 mm to 20.0 mm.

[0192] [Measurement conditions] Vertical load: 0.0981N, 0.294N, 0.491N Temperature: 20°C ± 5°C Sliding speed: 1mm / sec, 10mm / sec, 50mm / sec, 100mm / sec Sliding distance: 30.0mm

[0193] When measuring the coefficient of friction, the normal load pressing the sample 73 against the test piece 75 was determined by the following method. The balloon portion 21 and flexible printed wiring board portion 22 of the medical device 10 shown in Figure 1 were placed in the large intestine 5, and a fluid was supplied into the balloon portion 21 to inflate it, thereby setting the normal load pressing the sample 73 against the test piece 75 to 0.294 N as a load equivalent to the pressing force corresponding to the air pressure that can form a molded article having a spiral shape.

[0194] In Example 13, the measurement of the friction coefficient of the test piece of Example 1 was carried out three times for each normal load and each sliding speed. The average value of the three measurements was calculated and used as the friction coefficient of the test piece of Example 1. The results are shown in Table 13.

[0195]

[0196] Example 14: A mesh-like woven fabric was produced by smooth knitting using two identical 100 denier nylon (PA) filaments. Figure 5 is a photograph of the mesh-like woven fabric used in Example 14.

[0197] A test piece for Example 14 was obtained in the same manner as in Example 1, except that the mesh woven fabric shown in Figure 5 was wrapped around the test piece. The coefficient of friction of the test piece for Example 14 was then determined in the same manner as for the test piece for Example 13. The results are shown in Table 14.

[0198]

[0199] Example 15: A mesh-like woven fabric was produced by smooth knitting using a single 250 denier nylon (PA) filament. Figure 6 is a photograph of the mesh-like woven fabric used in Example 15.

[0200] A test piece for Example 15 was obtained in the same manner as in Example 1, except that the mesh woven fabric shown in Figure 6 was wrapped around the test piece. The coefficient of friction of the test piece for Example 15 was then determined in the same manner as for the test piece for Example 13. The results are shown in Table 15.

[0201]

[0202] Example 16: A mesh-like woven fabric was produced by smooth knitting using 300 denier nylon (PA) filaments, each consisting of three bundles of 20 yarns twisted in the same direction. Figure 7 is a photograph of the mesh-like woven fabric used in Example 16.

[0203] A test piece for Example 16 was obtained in the same manner as in Example 1, except that the mesh woven fabric shown in Figure 7 was wrapped around the test piece. The coefficient of friction of the test piece for Example 16 was then determined in the same manner as for the test piece for Example 13. The results are shown in Table 16.

[0204]

[0205] Example 17: A mesh-like woven fabric was produced by smooth knitting using 600 denier nylon (PA) filaments, each consisting of 6 bundles of 20 yarns twisted in the same direction. Figure 8 is a photograph of the mesh-like woven fabric used in Example 17.

[0206] A test piece for Example 17 was obtained in the same manner as in Example 1, except that the mesh woven fabric shown in Figure 8 was wrapped around the test piece. The coefficient of friction of the test piece for Example 17 was then determined in the same manner as for the test piece for Example 13. The results are shown in Table 17.

[0207]

[0208] Example 18 As a mesh woven fabric, a mesh-like knitted fabric was produced by smooth knitting using filaments made of 210 denier polyethylene terephthalate (PET) consisting of 96 threads.

[0209] A test piece for Example 18 was obtained in the same manner as in Example 1, except that the mesh woven fabric described above was wrapped around the test piece. The coefficient of friction of the test piece for Example 18 was then determined in the same manner as for the test piece for Example 13. The results are shown in Table 18.

[0210]

[0211] Example 19 A mesh-like woven fabric was produced by smooth knitting using 190 denier filaments, which consisted of one core material made of polyurethane (PU) and 96 covering materials made of polyethylene terephthalate (PET) spirally wound around the core material.

[0212] A test piece for Example 19 was obtained in the same manner as in Example 1, except that the mesh woven fabric described above was wrapped around the test piece. The coefficient of friction of the test piece for Example 19 was then determined in the same manner as for the test piece for Example 13. The results are shown in Table 19.

[0213]

[0214] Comparative Example 2 The coefficient of friction of the test piece of Comparative Example 1 was determined in the same manner as the test piece of Example 13, except that the test piece of Comparative Example 1 was used. The results are shown in Table 20.

[0215]

[0216] As shown in Tables 13 to 20, in Examples 13 to 19, which used test specimens in which a mesh woven fabric was fixed to the surface of a silicone resin sheet, the coefficient of friction tended to be higher than in Comparative Example 2, in which no mesh woven fabric was wrapped around the surface of the silicone resin sheet.

[0217] Furthermore, as shown in Tables 13 to 19, it was confirmed that the coefficient of friction was particularly high in Example 18, which used a mesh-shaped fabric made of 210 denier polyethylene terephthalate (PET) filaments consisting of 96 threads as the mesh-shaped fabric, and in Example 19, which used a mesh-shaped fabric made of 190 denier filaments consisting of one core material made of polyurethane (PU) and 96 covering materials made of polyethylene terephthalate (PET) wound spirally around the core material.

[0218] Furthermore, as shown in Tables 14 to 17, when a mesh-woven fabric made of nylon (PA) filaments was used as the mesh-like woven fabric, it was confirmed that the coefficient of friction could be changed by changing the denier (thickness) and shape of the filaments.

[0219] 5 large intestine, 10, 60 medical device, 21, 210 balloon portion (pressure portion), 21a, 22a resin sheet, 21b glassine paper, 21c, 21e, 21f, 22f bonding layer, 21d surface, 22 flexible printed wiring board portion, 22b wiring layer, 22c liquid crystal polymer layer, 22d metal wiring, 22e superelastic alloy wire, 22g insulating layer, 23, 63 mesh-like woven fabric (friction force imparting sheet), 31 connection portion, 23a edge portion, 32 conductive cable, 33 fluid supply / discharge tube, 51 large intestine wall, 52 crescent fold, 53 colon distension, 61 pressing portion, 62 shaft, 64 handle, 70 friction test device, 71 container, 72 liquid, 73 sample, 74 stage, 75 test piece.

Claims

1. A medical device that is placed in contact with tissues and organs in a living body and has a pressing part that presses against said tissues and organs, wherein a friction-imparting sheet is fixed to the surface of said pressing part.

2. The medical device according to claim 1, wherein the friction-imparting sheet is a mesh woven fabric.

3. The medical device according to claim 1, wherein the friction-imparting sheet is made of one layer of mesh fabric.

4. The medical device according to claim 2, wherein the mesh fabric is made of one to three layers of laminated cotton.

5. The medical device according to claim 2, wherein the mesh fabric is made of one to three laminated layers of polyethylene.

6. The medical device according to claim 1, wherein the pressure portion is an inflatable and deflatable balloon portion.

7. The medical device according to claim 6, wherein the frictional force imparting sheet is pressed against and fixed to the balloon portion by the expansion of the balloon portion.

8. The medical device according to claim 6, wherein the balloon portion is tubular, and when a fluid is supplied into the balloon portion, the balloon portion is formed into a molded body having a spiral shape, and the molded body is pressed outward from the central axis of the spiral shape.

9. The medical device according to claim 6, wherein the balloon portion is placed in the large intestine and presses against the wall of the large intestine when a fluid is supplied into the balloon portion.

10. The medical device according to claim 1, wherein the pressing portion is a retraction device that retracts the tissue and the organ.

11. The medical device of claim 2, wherein the mesh fabric is made of polyurethane and / or polyethylene terephthalate.

12. The medical device according to claim 2, wherein the mesh fabric is a fabric in which filaments formed by bundling a plurality of threads are woven into a mesh.

13. The medical device of claim 12, wherein the filament comprises one or more core materials made of a first fiber and one or more covering materials made of a second fiber of a different type than the first fiber, spirally wound around the core material.

Images