Guide devices for medical instruments and endoscopes

Abstract

To provide a medical instrument guide device and an endoscope device that can improve the insertion of medical instruments. [Solution] The device comprises a tube body (606) having a flexible outer tube (602) and a flexible inner tube (604) disposed inside the outer tube (602), and a shape-changing body (612) provided between the outer tube and the inner tube, wherein the shape-changing body has a plurality of joint ring members (42), and each joint ring member has a fixed ring member (46) and a plurality of joint pieces (48), and when an axially adjacent joint ring member is designated as a first joint piece (A) and an axially adjacent joint piece extending from one side to the other is designated as a second joint piece (B), the first joint piece and the second joint piece are positioned at axially offset positions and at circumferentially offset positions.

Description

Technical Field

[0001] The present invention relates to a guiding device for medical instruments that guides medical instruments such as the insertion part of an endoscope into the body, and an endoscope device.

Background Art

[0002] The insertion part of an endoscope (hereinafter also referred to as the "endoscope insertion part") is inserted, for example, along a flexible insertion path such as the upper digestive tract or the lower digestive tract. Therefore, the endoscope insertion part has flexibility that allows it to be inserted along the insertion path.

[0003] By the way, a part of the intestinal tract, which is an example of the insertion path, is not fixed to the body (for example, the sigmoid colon, etc.), and when inserting the endoscope insertion part, even if the insertion part is pushed in, the above-mentioned part will deform on the way, so there is a problem that it is difficult for the tip of the insertion part to advance. Also, during the treatment with an endoscope, when a delicate operation of cutting out a lesion by guiding a treatment tool from the tip of the insertion part is performed, the deformation of the above-mentioned part may interfere with the delicate operation.

[0004] Therefore, Patent Document 1 discloses a guide tube for eliminating unstable operations during insertion and treatment. The guide tube of Patent Document 1 arranges a long linear body having an engaging surface and a strength retaining member in a sealed space between a flexible inner tube and an outer tube, discharges fluid from the sealed space to press the engaging surface against at least one of the inner tube or the outer tube to make it in a pressed state, and supplies fluid into the sealed space to release the pressed state. According to this guide tube, it is possible to cause a hardness change between a flexible state and a highly rigid state in the bending direction.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] However, with guide tubes (medical instrument guide devices) like those in Patent Document 1, if the hardness is changed to a high-rigidity state, it is difficult to ensure a sufficient contact area between the engaging surface of the muscle and the inner or outer tube. As a result, it becomes difficult to maintain the shape of the medical instrument guide device in a curved shape that conforms to the curved part of the intestinal tract, which leads to a problem of reduced insertability of medical instruments such as endoscope insertion tubes or treatment instruments. On the other hand, increasing the number of the muscle, as described above, makes it possible to ensure a sufficient contact area, but in that case, the flexibility of the medical instrument guide device is impaired, which leads to a problem of reduced insertability of medical instruments.

[0007] This invention has been made in view of these circumstances, and aims to provide a medical instrument guide device and an endoscope device that can improve the insertability of medical instruments. [Means for solving the problem]

[0008] To solve the above problems, the present invention provides a medical device guide device for guiding a medical device into the body, comprising: a tube body having a flexible outer tube and a flexible inner tube disposed inside the outer tube; and a shape-changing body provided between the outer tube and the inner tube, which can be deformed to conform to the shape of the tube body.

[0009] According to one embodiment of the present invention, the present invention comprises an intermediate layer provided between an outer tube and an inner tube, which is in contact with a shape-variable body, and has a first contact surface provided on the shape-variable body and a second contact surface provided on the intermediate layer and facing the first contact surface, wherein at least a portion of either the first contact surface or the second contact surface includes a high-friction surface.

[0010] According to one embodiment of the present invention, the intermediate layer is preferably provided between the outer tube and the shape-variable body.

[0011] According to one embodiment of the present invention, the high-friction surface is preferably provided on the second contact surface.

[0012] According to one embodiment of the present invention, the high-friction surface is preferably provided on the first contact surface.

[0013] According to one embodiment of the present invention, it is preferable that the intermediate layer has a higher elastic modulus than the outer tube and the inner tube.

[0014] According to one embodiment of the present invention, the intermediate layer is preferably formed from a sheet material in a cylindrical shape.

[0015] According to one embodiment of the present invention, the invention has a fluid supply and discharge means for supplying and discharging fluid into and out of the internal space between an outer tube and an inner tube, and when the fluid in the internal space is discharged by the fluid supply and discharge means, it is preferable that the shape of the shape-variable body is maintained in the tube body by frictional engagement between the shape-variable body and the intermediate layer via a high-friction surface.

[0016] According to one embodiment of the present invention, the shape-variable body has a first contact surface provided on it and a second contact surface provided on at least one of the outer tube and inner tube and facing the first contact surface, and it is preferable that at least a portion of either the first contact surface or the second contact surface includes a high-friction surface.

[0017] According to one embodiment of the present invention, the device has a fluid supply and discharge means for supplying and discharging fluid into and out of the internal space between an outer tube and an inner tube, and when the fluid in the internal space is discharged by the fluid supply and discharge means, it is preferable that the shape of the shape-variable body is maintained by frictional engagement between the shape-variable body and one of the tubes via a high-friction surface.

[0018] According to one embodiment of the present invention, the high-friction surface is preferably a resin layer in which a resin is coated on one of the contact surfaces.

[0019] According to one embodiment of the present invention, the high-friction surface is preferably a rough surface formed on one of the contact surfaces.

[0020] According to one embodiment of the present invention, the high friction surface is preferably a resin layer in which a resin is coated on a rough surface formed on one contact surface.

[0021] According to one embodiment of the present invention, the shape-variable body preferably has a spiral tube in which a belt-like member is spirally wound around the outer peripheral side of the inner tube.

[0022] According to one embodiment of the present invention, the shape-variable body has a plurality of joint ring members arranged along the axial direction of the tube body. The joint ring member includes an annular fixed ring member provided so as to be able to fix the axial relative position with respect to the outer tube or the inner tube, and a plurality of joint pieces extending in a comb-like shape from the fixed ring member to at least one side in the axial direction. The plurality of joint pieces are preferably arranged side by side in the circumferential direction around the axial direction.

[0023] According to one embodiment of the present invention, the joint ring member preferably has a plurality of joint pieces extending from the fixed ring member to both sides in the axial direction.

[0024] According to one embodiment of the present invention, among the plurality of joint ring members, when the joint ring members adjacent in the axial direction are regarded as the first joint ring member and the second joint ring member, the joint piece extending to the side of the second joint ring member of the first joint ring member is regarded as the first joint piece, and the joint piece extending to the side of the first joint ring member of the second joint ring member is regarded as the second joint piece. The first joint piece end region on the side of the second joint ring member of the first joint piece and the second joint piece end region on the side of the first joint ring member of the second joint piece are preferably arranged at positions where the axial positions overlap each other and the circumferential positions are offset from each other.

[0025] In one embodiment of the present invention, the first joint piece and the second joint piece are preferably arranged alternately one by one along the circumferential direction.

[0026] According to one embodiment of the present invention, it is preferable that a plurality of first joint piece groups each consisting of two or more first joint pieces and a plurality of second joint piece groups each consisting of two or more second joint pieces are alternately arranged along the circumferential direction.

[0027] According to one embodiment of the present invention, among a plurality of joint ring members, when adjacent joint ring members in the axial direction are used as a first joint ring member and a second joint ring member, a joint piece extending to the side of the second joint ring member of the first joint ring member is used as a first joint piece, and a joint piece extending to the side of the first joint ring member of the second joint ring member is used as a second joint piece, it is preferable that the first joint piece and the second joint piece are arranged at positions where their axial positions are shifted from each other and at positions where their circumferential positions are shifted from each other.

[0028] According to one embodiment of the present invention, when the axial width of the joint ring member is W1 and the axial arrangement pitch of the joint ring member is P, it is preferable to satisfy the following formula P < W1.

[0029] According to one embodiment of the present invention, when the axial width of the joint ring member is W1 and the axial arrangement pitch of the joint ring member is P, it is preferable to satisfy the following formula P > W1.

[0030] According to one embodiment of the present invention, it is preferable that a plurality of joint pieces arranged side by side in the circumferential direction are arranged at equal intervals along the circumferential direction.

[0031] According to one embodiment of the present invention, it is preferable that a plurality of fixed ring members are arranged at equal intervals along the axial direction.

[0032] According to one embodiment of the present invention, it is preferable that the joint piece has a rectangular piece body formed elongated in the axial direction and a connecting member provided between the piece body and the fixed ring member and formed narrower than the piece body.

[0033] According to one embodiment of the present invention, it is preferable that at least one of the outer peripheral surface of the outer tube and the inner peripheral surface of the inner tube has a hydrophilic coat.

[0034] According to one embodiment of the present invention, the medical device is preferably an endoscope having an insertion portion that is inserted into the body.

[0035] According to one embodiment of the present invention, it is preferable that the medical device guide device has a switching member that can switch between opening to the atmosphere and inflowing with the atmosphere to the internal space located between the outer tube and the inner tube.

[0036] According to one embodiment of the present invention, it is preferable that the tube body has a portion that adheres to the body inside the body, which is provided at the tip of the tube body.

[0037] According to one embodiment of the present invention, the portion that adheres to the body is preferably composed of an expandable and contractible balloon for the tube body, which is positioned at the tip of the tube body.

[0038] According to one embodiment of the present invention, the portion that adheres to the body is preferably configured to have a suction port located at the tip of the tube body.

[0039] According to one embodiment of the present invention, it is preferable that the part that adheres to the body has a porous anti-entanglement member that covers the suction port.

[0040] To solve the above problems, the endoscopic device of the present invention comprises a medical instrument and a guide device for the medical instrument of the present invention, wherein the medical instrument is an endoscope having an insertion portion that is inserted into the body.

[0041] According to one embodiment of the present invention, it is preferable that the endoscope has a switching means that can switch between opening to the atmosphere and inflowing with the atmosphere to the internal space located between the outer tube and the inner tube.

[0042] According to one embodiment of the present invention, the insertion portion is insertable into the tube body, and it is preferable that a clearance is formed between the tube body and the insertion portion to prevent pinching of internal tissue when the insertion portion is inserted into the tube body.

[0043] According to one embodiment of the present invention, the clearance is preferably 4 mm or less.

[0044] According to one embodiment of the present invention, it is preferable that the insertion portion has an effective length that is 300 mm or longer than the total length of the tube body.

[0045] According to one embodiment of the present invention, the insertion portion preferably has an inflatable and deflated balloon for insertion provided at the tip of the insertion portion. [Effects of the Invention]

[0046] According to the present invention, the ease of insertion of medical devices can be improved. [Brief explanation of the drawing]

[0047] [Figure 1] Figure 1 is an external view of an endoscope device according to the first embodiment of the present invention. [Figure 2] Figure 2 is an enlarged cross-sectional view of the main part showing the structure of the guide tube in Figure 1. [Figure 3] Figure 3 is a perspective view showing the structure of the shape-adjustable body provided in the guide tube of Figure 1. [Figure 4] Figure 4 is an explanatory diagram schematically showing the arrangement of the joint ring members in Figure 3. [Figure 5] Figure 5 is a schematic diagram of the curved tube body. [Figure 6] Figure 6 is an explanatory diagram showing how to treat a lesion using a guide tube. [Figure 7] Figure 7 is an explanatory diagram showing how to treat a lesion using only an endoscope. [Figure 8] Figure 8 is a schematic explanatory diagram showing the arrangement of the joint ring member of the guide tube according to the second embodiment. [Figure 9] Figure 9 is a schematic explanatory diagram showing the arrangement of the joint ring member of the guide tube according to the third embodiment. [Figure 10] Figure 10 is a schematic explanatory diagram showing the arrangement of the joint ring member of the guide tube according to the fourth embodiment. [Figure 11] Figure 11 is a schematic explanatory diagram showing the arrangement of the joint ring member of the guide tube according to the fifth embodiment. [Figure 12] Figure 12 is a structural diagram of the spiral tube used as a guide tube in the sixth embodiment. [Figure 13] Figure 13 is an explanatory diagram showing how a spiral tube deforms into a curved shape. [Figure 14] Figure 14 is an enlarged cross-sectional view showing the structure of the guide tube according to the seventh embodiment. [Figure 15] Figure 15 is a longitudinal cross-sectional view of the guide tube along the line 15-15 in Figure 14. [Figure 16] Figure 16 is an enlarged cross-sectional view of the main part of the proximal end of the guide tube shown in Figure 14. [Figure 17] Figure 17 is an enlarged cross-sectional view of the main part at the tip of the guide tube shown in Figure 14. [Figure 18] Figure 18 is an external view of the spiral tube. [Figure 19] Figure 19 is an explanatory diagram showing the spiral tube shown in Figure 18 deformed into a curved shape. [Figure 20] Figure 20 is a perspective view of the sheet material. [Figure 21] Figure 21 is a front view of the sheet material shown in Figure 20. [Figure 22] Figure 22 is a side view showing a first modified example of the spiral tube. [Figure 23] Figure 23 is an external view showing a second modified example of the spiral tube. [Figure 24] Figure 24 is an external view showing a third modified example of the spiral tube. [Figure 25] Figure 25 is an external view showing a fourth modified example of the spiral tube. [Figure 26] Figure 26 is an external view showing a fifth modified example of the spiral tube. [Figure 27] Figure 27 is a longitudinal cross-sectional view showing the structure of the guide tube according to the eighth embodiment. [Figure 28] Figure 28 is a perspective view of an endoscope device according to a second embodiment of the present invention. [Figure 29]Figure 29 is a cross-sectional view of the guide tube into which the insertion portion has been inserted. [Figure 30] Figure 30 shows the piping diagram when a pump is used in conjunction with the piping. [Figure 31] Figure 31 is an explanatory diagram showing the procedure for using the endoscopic device shown in Figure 28. [Figure 32] Figure 32 is an explanatory diagram showing the procedure for using the endoscopic device shown in Figure 28. [Figure 33] Figure 33 is a cross-sectional view showing the balloon of the first modified example. [Figure 34] Figure 34 is a cross-sectional view showing the balloon of the second modified example. [Figure 35] Figure 35 is a cross-sectional view showing the balloon of the third modified example. [Figure 36] Figure 36 is a cross-sectional view showing the balloon of the fourth modified example. [Figure 37] Figure 37 is a cross-sectional view showing the balloon of the fifth modified example. [Figure 38] Figure 38 is a front view showing the balloon of the sixth modified example. [Figure 39] Figure 39 is a perspective view of the main part of the tube body to which another form of internal contact section is applied. [Figure 40] Figure 40 is a cross-sectional view of the main part of the tube body shown in Figure 39. [Modes for carrying out the invention]

[0048] Hereinafter, embodiments of the medical instrument guide device and endoscope device of the present invention will be described with reference to the attached drawings.

[0049] Figure 1 is an external view of an endoscope device 1 according to a first embodiment of the present invention. As shown in Figure 1, the endoscope device 1 comprises a medical instrument guide device (hereinafter referred to as "guide tube") 10 of the first embodiment and an endoscope 12. Figure 1 shows a usage configuration in which the insertion portion 14 of the endoscope 12 is inserted into the guide tube 10. In Figure 1, the endoscope 12 has an insertion portion 14 and a handheld operating portion 16, and the proximal end of the insertion portion 14 is connected to the handheld operating portion 16. Here, the endoscope 12 having an insertion portion 14 is an example of a medical instrument of the present invention.

[0050] The insertion section 14 is constructed by sequentially connecting a rigid tip section 18, a curved section 20, and a flexible section 22 from the tip end to the base end. In Figure 1, the rigid tip section 18 and the curved section 20 are shown protruding outward from the tip opening 10A of the guide tube 10.

[0051] The rigid tip section 18 is provided with a pair of illumination windows 24 for illuminating the inside of the body and an observation window 26 for acquiring images of the inside of the body under illumination from these illumination windows 24. The rigid tip section 18 is also provided with an instrument outlet (not shown) for bringing out instruments such as forceps or high-frequency instruments. On the other hand, the curved section 20 is bent in a desired direction by operating an angle knob (not shown) provided on the hand-operated section 16. The flexible section 22 is made of a flexible material that is pliable in the bending direction. Since the configuration of the endoscope 12 is conventionally known, detailed illustrations and explanations are omitted here. The guide tube 10 according to the first embodiment will be described below.

[0052] Figure 2 is an enlarged cross-sectional view of the main part showing the structure of the guide tube 10. As shown in Figure 2, the guide tube 10 has a double-tube structure tube body 34 having a flexible outer tube 30 and a flexible inner tube 32 positioned inside the outer tube 30. The outer tube 30 and the inner tube 32 are made of a flexible resin material that can be bent along the curved portion of the intestinal tract, for example. Examples of flexible resin materials include urethane or polyester resin, but are not limited to these. The thickness of the outer tube 30 and the inner tube 32 is approximately 100 μm each, as an example, and the thickness of the internal space 36 located between the outer tube 30 and the inner tube 32 is approximately 800 μm, as an example. Note that the thicknesses of the outer tube 30, the inner tube 32, and the internal space 36 are not limited to the above thicknesses and are set based on the diameter of the insertion portion 14 (see Figure 1) and the diameter of the insertion path into which the insertion portion 14 is inserted, etc.

[0053] The internal space 36 described above is an annular (donut-shaped) space formed such that the cross-sectional shape in the direction perpendicular to the axis Ax of the guide tube 10 surrounds the periphery (outer circumference) of the inner tube 32, and a shape-variable body 28, described later, is arranged therein. This internal space 36 is formed as a sealed space by sealing the outer tube 30 and the inner tube 32 at the tip and base ends of the tube body 34. Furthermore, as shown in Figure 1, a pump 38 for supplying and discharging fluid (e.g., air) to and from the internal space 36 is connected to the guide tube 10 via piping 40. Here, the pump 38 and piping 40 function as the fluid supply and discharge means of the present invention.

[0054] The shape-variable body 28 is provided between the outer tube 30 and the inner tube 32 (i.e., the internal space 36 described above). The shape-variable body 28 can be deformed to conform to the shape of the tube body 34 and has a plurality of joint ring members 42 arranged along the axis Ax direction of the tube body 34, as will be described later.

[0055] The following describes in detail the multiple joint ring members 42 that constitute the shape-variable body 28 with reference to Figure 3. Figure 3 is a perspective view showing the structure of the shape-variable body 28 provided in the guide tube 10. In Figure 3, two joint ring members 42A and 42B that are adjacent in the axial Ax direction are shown among the multiple joint ring members 42. Here, the joint ring members 42 correspond to the joint ring members of the present invention. Furthermore, joint ring member 42A corresponds to the first joint ring member of the present invention, and joint ring member 42B corresponds to the second joint ring member of the present invention.

[0056] The multiple joint ring members 42 (see Figure 2) that constitute the shape-variable body 28 are arranged at equal intervals along the axis Ax direction of the tube body 34, and each joint ring member 42 has the same configuration. As shown in Figure 3, two adjacent joint ring members 42A and 42B in the axis Ax direction are arranged so that the joint pieces 48, which will be described later, do not interfere with each other, with the circumferential C positions of the joint ring members 42A and 42B offset from each other.

[0057] The joint ring member 42 (42A, 42B) has a fixed ring member 46 formed in an annular shape to surround the outer circumference of the inner tube 32, and a plurality of joint pieces 48 extending in a comb-like manner from the fixed ring member 46 to both sides in the axial Ax direction. The joint ring member 42 is formed integrally from the same material as the fixed ring member 46 and the plurality of joint pieces 48. The joint ring member 42 is preferably formed from a resin material such as polypropylene resin. Alternatively, the joint ring member 42 may be made from a metal material such as stainless steel.

[0058] The fixing ring member 46 is provided so as to be able to fix its relative position in the axial Ax direction with respect to the outer tube 30 or the inner tube 32. In this embodiment, as shown in Figure 2, the fixing ring member 46 has a fixing piece 49 that protrudes toward the inner tube 32 side, and this fixing piece 49 is fixed to the outer circumferential surface of the inner tube 32 by a fixing means such as adhesive. As a result, the fixing ring member 46 is fixed in the above relative position. Note that the fixing form of the fixing ring member 46 is not limited to the configuration shown in Figure 2, and the fixing piece 49 may be fixed to the inner circumferential surface of the outer tube 30 by protruding toward the outer tube 30 side, or the fixing piece 49 may be fixed to both the inner tube 32 side and the outer tube 30 side by protruding toward both the inner tube 32 side and the outer tube 30 side.

[0059] As shown in Figure 3, the multiple joint pieces 48 extend in a comb-like manner from the fixing ring member 46 to both sides in the axial Ax direction. Each joint piece 48 extending to one side from the fixing ring member 46 is arranged at equal intervals along the circumferential direction C around the axial Ax direction, following the shape (annular) of the fixing ring member 46.

[0060] The joint piece 48 has a single body 50 and a connecting member 52. The single body 50 is formed in an elongated rectangular shape in the axial Ax direction. The connecting member 52 connects the single body 50 and the fixing ring member 46. The connecting member 52 is formed to be narrower than the single body 50 and has the function of smoothly aligning the single body 50 with the fixing ring member 46 in the direction of curvature of the tube body 34 when the tube body 34 is curved, for example, along a curved portion of the intestinal tract.

[0061] The joint ring member 42 has a high-friction surface 54 on the surface that contacts the outer tube 30 (hereinafter referred to as the "first contact surface"). Specifically, the high-friction surface 54 is provided on the first contact surfaces of both the fixed ring member 46 and the joint piece 48 that constitute the joint ring member 42. When the air in the internal space 36 is discharged by the pump 38 (see Figure 1), the inner circumferential surface of the outer tube 30 is pressed against the joint ring member 42 and they adhere tightly, and the outer circumferential surface of the inner tube 32 is pressed against the joint ring member 42 and they adhere tightly, thereby fixing the position of the joint ring member 42. As a result, the state of the tube body 34 changes from a flexible state to a highly rigid state. At this time, the joint ring member 42 and the outer tube 30 adhere tightly and frictionally engage via the high-friction surface 54. As a result, the shape of the shape-variable body 28 (for example, a curved shape) is held in a non-deformable state, and the shape-holding force of the tube body 34 in the highly rigid state (when hardened) is increased. Conversely, when air is introduced into the internal space 36 from a state where air has been expelled, the shape retention of the shape-variable body 28 is released, and the tube body 34 changes from a highly rigid state (hardened state) to a flexible state (unhardened state, softened state).

[0062] Here, the term "high friction surface" as used herein refers to a contact surface with a higher coefficient of friction than a contact surface on which a high friction surface is not formed. The coefficient of friction of the high friction surface can be measured, for example, by the method described in JIS P8147:2010 or a method compliant therewith. This high friction surface has a higher coefficient of friction than the outer circumferential surface of the outer tube 30 and the inner circumferential surface of the inner tube 32. Furthermore, "immovable" as used herein refers to the fact that the shape of the shape-variable body 28 is fixed when the air in the internal space 36 is discharged. Furthermore, "frictional engagement" as used herein refers to the engagement of each contact surface with frictional force. This frictional force is the frictional force generated when each contact surface contacts each other in the radial direction of the tube body 34 when viewed from the axial Ax direction of the tube body 34. Furthermore, each contact surface is formed in a substantially circular shape when viewed from the axial Ax direction. Specific examples of high friction surfaces are described below.

[0063] An example of a high-friction surface 54 is a resin layer coated with resin on the first contact surface of the joint ring member 42. In this case, it is preferable to use a resin such as silicone with a high coefficient of friction. Another example of a high-friction surface 54 is a rough surface formed on the first contact surface. This rough surface is formed by applying a roughening treatment such as blasting, laser irradiation, chemical conversion treatment, or etching to the first contact surface. Furthermore, other examples of high-friction surfaces 54 include a resin layer coated on the first contact surface that has been roughened, and a rough surface on the first contact surface that has been roughened and then coated with resin.

[0064] In this embodiment, as an example, the surface in contact with the inner circumferential surface of the outer tube 30 is shown as the first contact surface of the joint ring member 42 on which the high-friction surface 54 is provided. However, the embodiment is not limited to this, and the high-friction surface 54 may be provided on the surface in contact with the outer circumferential surface of the inner tube 32 (first contact surface). In other words, the high-friction surface 54 only needs to be provided on a surface in contact with at least one of the tubes, the outer tube 30 and the inner tube 32. For example, even if the high-friction surface 54 is provided on the surface in contact with the inner tube 32, the frictional force between the joint ring member 42 and the inner tube 32 can be increased, thereby improving the shape retention force of the tube body 34 during hardening. Alternatively, the high-friction surface 54 may be provided on each of the surfaces in contact with the outer tube 30 and the inner tube 32. Furthermore, in this embodiment, a preferred embodiment is shown in which the high-friction surface 54 is provided on both the fixing ring member 46 and the joint piece 48. However, the embodiment is not limited to this, and the high-friction surface 54 only needs to be provided on at least one of the fixing ring member 46 and the joint piece 48. Furthermore, when a high-friction surface 54 is provided on either the fixing ring member 46 or the joint piece 48, the configuration in which the high-friction surface 54 is provided on the joint piece 48 is preferable, as it is possible to obtain an effect that enhances the shape retention force of the tube body 34 during hardening compared to the configuration in which the high-friction surface 54 is provided on the fixing ring member 46. In addition, the high-friction surface 54 may be provided on the inner circumferential surface of the outer tube 30, on the surface in contact with the joint ring member 42 (second contact surface), or on the outer circumferential surface of the inner tube 32, on the surface in contact with the joint ring member 42 (second contact surface). Moreover, it may be provided on both the outer tube 30 and the inner tube 32.

[0065] Figure 4 is a schematic diagram illustrating the relative positions of the joint ring members 42A and 42B shown in Figure 3. Below, an example of the relative positions of the joint ring members 42A and 42B shown in Figure 3 will be explained using Figure 4.

[0066] Here, in order to explain the above-described arrangement positions more clearly, the joint piece 48 extending toward the joint ring member 42B of the joint ring member 42A is referred to as the first joint piece A, and the joint piece 48 extending toward the joint ring member 42A of the joint ring member 42B is referred to as the second joint piece B for explanation. In this case, the first joint piece end region a on the side of the joint ring member 42B of the first joint piece A and the second joint piece end region b on the side of the joint ring member 42A of the second joint piece B are arranged at positions where the positions in the axial direction Ax overlap each other, and the positions in the circumferential direction C are offset from each other. That is, the joint ring members 42A and 42B are arranged so as to satisfy P < W1 when the width in the axial direction Ax of the joint ring members 42A and 42B is W1 and the arrangement pitch in the axial direction Ax of the joint ring members 42A and 42B is P. Further, the first joint piece A and the second joint piece B are alternately arranged one by one along the circumferential direction C.

[0067] According to the arrangement positions shown in FIGS. 3 and 4, as the tube body 34 curves, the first joint piece end region a and the second joint piece end region b located on the inner peripheral side with a small radius of curvature of the tube body 34 move relatively in a direction approaching each other, and the first joint piece end region a and the second joint piece end region b located on the outer peripheral side with a large radius of curvature of the tube body 34 move relatively in a direction away from each other. Then, as shown in the schematic diagram of the curved tube body 34 shown in FIG. 5, the shape variable body 28 shown in FIG. 3 is deformed into a curved shape following the curved shape of the tube body 34. When the tube body 34 is cured in this state, the tube body 34 is held in the curved shape which is its shape at that time. Further, by arranging the joint ring member 42A and the joint ring member 42B along the axial direction Ax as shown in FIG. 3, the tube body 34 (particularly the inner tube 32) is covered by the plurality of joint ring members 42, so that the tube body 34 can be cured without buckling.

[0068] The maximum curvature of the tube body 34 is determined by the flexibility of the tube body 34 itself, and the gap between the first joint end region a and the second joint end region b in the circumferential direction C. As a result, the tube body 34 can bend flexibly from the straight rod shape shown in Figure 1 to the maximum curvature, and the curved shape can be maintained when the tube body 34 is hardened.

[0069] On the other hand, as shown in Figure 2, the guide tube 10 has a mesh tube (also called a braid or braided net) 56 in the internal space 36 of the tube body 34. For example, this mesh tube 56 is placed in the space between the inner tube 32 and the shape-changing body 28 within the internal space 36 and covers the outer circumference of the inner tube 32. Buckling of the tube body 34 is also prevented by this mesh tube 56. Although the mesh tube 56 is not an essential component of the guide tube 10, it is preferable to include the mesh tube 56 from the viewpoint of preventing the buckling mentioned above.

[0070] Next, an example of the procedure for guiding the insertion section 14 of the endoscope 12 into the large intestine using the guide tube 10 will be explained with reference to the schematic diagram of the large intestine 500 shown in Figure 6.

[0071] As shown in Figure 6, the tube body 34 of the guide tube 10 is inserted transanally into the large intestine 500 with the insertion section 14 of the endoscope 12 inserted through it. At this time, it is preferable that the rigid tip 18 of the insertion section 14 of the endoscope 12 is inserted into the large intestine 500 with the rigid tip 14 protruding forward from the tip opening 10A (see Figure 1) of the tube body 34. This allows a view of the area in front of the insertion direction to be obtained through the illumination window 24 and observation window 26 of the rigid tip 18. While obtaining this view, the tube body 34 and the insertion section 14 inserted through the tube body 34 are inserted along the large intestine 500. At this time, since the insertion section 14 and the tube body 34 are flexible, they are smoothly inserted along the curved shape of the large intestine 500.

[0072] Here, for example, when treating a lesion 506 in the transverse colon 504 with an endoscope 12 while the tube body 34 is aligned with the curved shape of the sigmoid colon (the part not fixed to the body) 502, the pump 38 (see Figure 1) is activated to aspirate air from the internal space 36 through the piping 40. At this time, the tube body 34 deforms into a curved shape to match the curved shape of the sigmoid colon 502. As a result, the shape-changing body 28 (see Figure 3), which is composed of multiple joint ring members 42, deforms into a curved shape to match the curved shape of the tube body 34 (i.e., the curved shape of the sigmoid colon).

[0073] As air is drawn out of the internal space 36 as described above, the outer tube 30 and inner tube 32 of the tube body 34 are pressed against the multiple joint ring members 42 that constitute the shape-variable body 28. As a result, each joint ring member 42 comes into close contact with the inner tube 32, and the high-friction surface 54 of each joint ring member 42 comes into close contact with the outer tube 30 and engages in friction. This causes the tube body 34 to harden into a shape corresponding to the curved shape of the sigmoid colon 502, and this shape is maintained, thereby improving the insertability of the insertion portion 14 into the sigmoid colon 502.

[0074] Next, the curved portion 20 of the insertion portion 14 is extended forward from the tip opening 10A of the guide tube 10, and the treatment instrument (not shown) is led forward from the treatment instrument outlet (not shown) of the rigid tip portion 18 to begin treatment of the lesion 506 of the transverse colon 504. At this time, since the insertability of the insertion portion 14 into the sigmoid colon 502 is improved by the guide tube 10, the rigid tip portion 18 can be positioned accurately for treatment, and as a result, accurate treatment of the lesion 506 becomes possible.

[0075] Figure 7 is a schematic diagram of a procedure performed on the lesion 506 using only the endoscope 12 without the use of a guide tube 10, and is an explanatory diagram comparing it with the procedure in Figure 6. According to the procedure in Figure 7, even if the insertion part 14 is pushed into the large intestine 500, the sigmoid colon 502 deforms, making it difficult for the rigid tip 18 of the insertion part 14 to advance, and also making it difficult to adjust the position of the rigid tip 18. As a result, it becomes difficult to perform an accurate procedure on the lesion 506. In contrast, according to the procedure in Figure 6, which is performed in combination with the guide tube 10, the insertability of the insertion part 14 into the sigmoid colon 502 is improved by the guide tube 10, making it easier for the rigid tip 18 to advance, and also making it easier to adjust the position of the rigid tip 18. As a result, it becomes possible to perform an accurate procedure on the lesion 506.

[0076] As described above, according to the guide tube 10 of the first embodiment, the shape-changing body 28 has a plurality of joint ring members 42 arranged along the axis Ax direction of the tube body 34, each joint ring member 42 has a fixed ring member 46 and a plurality of joint pieces 48, and furthermore, each joint ring member 42 has a high friction surface 54 on its first contact surface (the surface that contacts at least one of the tubes, the outer tube 30 and the inner tube 32), so that the shape-retaining force of the tube body 34 can be increased while maintaining flexibility. As a result, according to the guide tube 10 of the first embodiment, the insertability of the insertion portion 14 of the endoscope 12 can be improved.

[0077] Furthermore, since the multiple joint pieces 48 of each joint ring member 42 are arranged at equal intervals along the circumferential direction C, a uniform shape-retaining force can be obtained regardless of the direction in which the tube body 34 is bent.

[0078] In this embodiment, one preferred configuration is shown in which the joint pieces 48 are arranged at equal intervals in the circumferential direction C. However, the embodiment is not limited to this configuration, and the joint pieces 48 do not necessarily have to be arranged at equal intervals in the circumferential direction C. For example, the spacing of the joint pieces 48 in the circumferential direction C may be changed periodically.

[0079] Next, several other embodiments relating to the guide tube will be described.

[0080] Figure 8 is a schematic diagram showing the main components of the shape-changing body 28A provided in the guide tube 60 according to the second embodiment. In Figure 8, the relative positions of adjacent joint ring members 142A and 142B in the direction of axis Ax are schematically shown among a plurality of joint ring members 142 arranged along the axis Ax direction. Components common to the first embodiment are denoted by the same reference numerals.

[0081] The difference between the first and second embodiments is that in the guide tube 10 of the first embodiment, the first joint piece A and the second joint piece B are arranged alternately one by one along the circumferential direction C, whereas in the guide tube 60 of the second embodiment, multiple groups of first joint pieces D, each consisting of two first joint pieces A (two groups of first joint pieces D are shown in Figure 8), and multiple groups of second joint pieces E, each consisting of two second joint pieces B (one group of second joint pieces E is shown in Figure 8), are arranged alternately along the circumferential direction C. The other components are the same, so their explanation will be omitted.

[0082] In the second embodiment, as with the guide tube 10, as the tube body 34 (see Figure 2) curves, the first joint piece group D and the second joint piece group E located on the inner circumference of the tube body 34 move relatively toward each other, while the first joint piece group D and the second joint piece group E located on the outer circumference of the tube body 34 move relatively toward each other. By hardening the tube body 34 in a curved state, the tube body 34 can be maintained in a curved shape.

[0083] Therefore, the guide tube 60 of the second embodiment, like the guide tube 10, can maintain flexibility while increasing the shape-retaining force of the tube body 34, thereby improving the insertability of the insertion portion 14 of the endoscope 12.

[0084] In the second embodiment, a configuration was shown in which two first joint pieces A constitute the first joint piece group D and two second joint pieces B constitute the second joint piece group E. However, the embodiment is not limited to this, and the first joint piece group D and the second joint piece group E may be composed of three or more first joint pieces A and second joint pieces B, respectively. Furthermore, it is preferable that the first joint piece group D and the second joint piece group E are configured at equal intervals in the circumferential direction C, thereby enabling uniform shape retention regardless of the direction in which the tube body 34 is curved.

[0085] Figure 9 is a schematic diagram showing the main components of the shape-changing body 28B provided in the guide tube 70 according to the third embodiment. In Figure 9, the relative positions of adjacent joint ring members 242A and 242B in the direction of axis Ax are schematically shown among a plurality of joint ring members 242 arranged along the axis Ax direction. Components common to the first embodiment are denoted by the same reference numerals.

[0086] The difference between the first and third embodiments is that in the guide tube 10 of the first embodiment, the positions of the first joint end region a and the second joint end region b in the axial Ax direction overlap with each other, whereas in the guide tube 70 of the third embodiment, the positions of the first joint piece A and the second joint piece B in the axial Ax direction are offset from each other. That is, in the guide tube 70, the joint ring members 242A and 242B are arranged such that P > W1, where W1 is the width of the joint ring members 242A and 242B in the axial Ax direction and P is the arrangement pitch of the joint ring members 242A and 242B in the axial Ax direction. However, they may also be arranged so that P = W1. Other configurations are the same and will not be explained.

[0087] In the third embodiment, as with the guide tube 10, as the tube body 34 (see Figure 2) curves, the first joint end region a and the second joint end region b located on the inner circumference of the tube body 34 move relatively toward each other, while the first joint end region a and the second joint end region b located on the outer circumference of the tube body 34 move relatively toward each other. By hardening the tube body 34 in a curved state, the tube body 34 can be maintained in a curved shape.

[0088] Therefore, the guide tube 70 of the third embodiment, like the guide tube 10, can maintain flexibility while increasing the shape-retaining force of the tube body 34, thereby improving the insertability of the insertion portion 14 of the endoscope 12.

[0089] Figure 10 is a schematic diagram showing the main components of the shape-changing body 28C provided in the guide tube 80 according to the fourth embodiment. In Figure 10, the relative positions of adjacent joint ring members 342A and 342B in the direction of axis Ax are schematically shown among a plurality of joint ring members 342 arranged along the axis Ax direction. Components common to the third embodiment are denoted by the same reference numerals.

[0090] The differences between the third and fourth embodiments are that in the guide tube 70 of the third embodiment, the spacing between the multiple first joint pieces A and the multiple second joint pieces B in the circumferential direction C is wide, whereas in the guide tube 80 of the fourth embodiment, the spacing between the multiple first joint pieces A and the multiple second joint pieces B in the circumferential direction C is narrow, and the positions of the first joint piece end region a and the second joint piece end region b in the circumferential direction C overlap. Other configurations are the same, so their explanation is omitted.

[0091] The guide tube 80 of the fourth embodiment, configured in this way, can improve the shape retention of the tube body 34 while maintaining flexibility, similar to the guide tube 70, thereby improving the insertability of the insertion portion 14 of the endoscope 12.

[0092] Figure 11 is a schematic diagram showing the main components of the shape-changing body 28D provided in the guide tube 90 according to the fifth embodiment. In Figure 11, the relative positions of adjacent joint ring members 442A and 442B in the direction of axis Ax are schematically shown among a plurality of joint ring members 442 arranged along the axis Ax direction. Components common to the fourth embodiment are denoted by the same reference numerals.

[0093] The difference between the fourth and fifth embodiments is that in the guide tube 80 of the fourth embodiment, multiple joint pieces 48 extend from the fixed ring member 46 to both sides in the axial Ax direction, whereas in the guide tube 90 of the fifth embodiment, multiple joint pieces 48 of each of the joint ring members 442A and 442B extend from the fixed ring member 46 to only one side in the axial Ax direction (the left side in Figure 11). The other configurations are the same, so their explanation is omitted. In the guide tube 90, the width (W2) is smaller than the width (W1) of the guide tube 80 in which the joint pieces 48 extend to both sides, but they are arranged in the same way as the guide tube 80 so that P > W2.

[0094] According to the guide tube 90 of the fifth embodiment, as the tube body 34 (see Figure 2) curves, the fixing ring member 46 of the joint ring member 442A and the joint piece 48 of the joint ring member 442B, located on the inner circumference side of the tube body 34, move relatively toward each other, while the fixing ring member 46 of the joint ring member 442A and the joint piece 48 of the joint ring member 442B, located on the outer circumference side of the tube body 34, move relatively toward each other. By hardening the tube body 34 in a curved state, the tube body 34 can be maintained in a curved shape.

[0095] Therefore, the guide tube 90 of the fifth embodiment, like the guide tube 80, can maintain flexibility while increasing the shape-retaining force of the tube body 34, thereby improving the insertability of the insertion portion 14 of the endoscope 12.

[0096] Figure 12 is a schematic diagram showing the main components of the shape-changing body 28E provided in the guide tube 100 according to the sixth embodiment.

[0097] The difference between the first to fifth embodiments and the sixth embodiment is that in the guide tubes 10, 60, 70, 80, and 90 of the first to fifth embodiments, joint ring members 42, 142, 242, 342, and 442 were used as shape-variable members 28, 28A to 28D, whereas in the guide tube 100 of the sixth embodiment, a spiral tube 104 was used as the shape-variable member 28E. Other components are the same and will not be explained.

[0098] The spiral tube 104 is formed by spirally winding a strip-shaped member 106 and is provided on the outer circumference of the inner tube (see Figure 2). The spiral tube 104 also has a high-friction surface 54 on the surface (first contact surface) that contacts at least one of the tubes (outer tube 30 in Figure 12) of the outer tube 30 and inner tube 32 shown in Figure 2. As a result, when air in the internal space 36 is discharged by the pump 38 (see Figure 1), the tube body 34 of the guide tube 100 (see Figure 2) and the spiral tube 104 and the outer tube 30 come into close contact and frictionally engage via the high-friction surface 54. Consequently, the shape of the spiral tube 104 is maintained in an immovable manner, thereby increasing the shape-retaining force of the tube body 34 when in a high-rigidity state (when hardened). Furthermore, since the spiral tube 104 is flexible in the bending direction, its shape can be deformed into a curved shape, for example, as shown in Figure 13.

[0099] Next, we will describe an example of the procedure when using the guide tube 100 to guide the insertion section 14 of the endoscope 12 into the large intestine 500 (see Figure 6).

[0100] First, when the tube body 34 and the insertion portion 14 inserted through the tube body 34 are inserted along the large intestine 500, the insertion portion 14, the tube body 34, and the spiral tube 104 are all flexible and are smoothly inserted along the curved shape of the large intestine 500.

[0101] Next, with the tube body 34 aligned with the curved shape of the sigmoid colon 502, the pump 38 is activated to suction air from the internal space 36 through the piping 40, causing the outer tube 30 and inner tube 32 to be pressed against the spiral tube 104. As a result, the spiral tube 104 adheres tightly to the inner tube 32, and the high-friction surface 54 of the spiral tube 104 adheres tightly to the outer tube 30, resulting in frictional engagement. This causes the tube body 34 to harden into a shape corresponding to the curved shape of the sigmoid colon 502, and this shape is maintained, improving the insertability of the insertion portion 14 into the sigmoid colon 502.

[0102] Next, the curved portion 20 of the insertion section 14 is extended forward from the tip opening 10A of the guide tube 100, and the treatment instrument (not shown) is led forward from the treatment instrument outlet (not shown) of the rigid tip section 18 to begin treatment of the lesion 506 of the transverse colon 504. At this time, since the insertability of the insertion section 14 into the sigmoid colon 502 is improved by the guide tube 100, the rigid tip section 18 can be positioned accurately for treatment, and as a result, accurate treatment of the lesion 506 becomes possible.

[0103] As described above, according to the guide tube 100 of the sixth embodiment, the shape-changing body 102 has a spiral tube 104, and the spiral tube 104 has a high-friction surface 54, so that the shape-retaining force of the tube body 34 can be increased while maintaining flexibility. As a result, according to the guide tube 100 of the sixth embodiment, the insertability of the insertion portion 14 of the endoscope 12 can be improved. In addition, in the sixth embodiment as well, the high-friction surface 54 may be provided on the surface of the spiral tube 104 that is in contact with the inner tube 32, or the high-friction surface 54 may be provided on at least one of the tubes, the outer tube 30 and the inner tube 32.

[0104] Figure 14 is an enlarged cross-sectional view showing the structure of the guide tube 600 according to the seventh embodiment. In Figure 14, a portion of the guide tube 600 in the axial Ax direction is shown broken off. Figure 15 is a schematic cross-sectional view of the guide tube 600 along the line XV-XV in Figure 14. Components common to the guide tube 10 of the first embodiment are denoted by the same reference numerals.

[0105] As shown in Figures 14 and 15, the guide tube 600 has a double-tube structure tube body 606 having a flexible outer tube 602 and a flexible inner tube 604 positioned inside the outer tube 602. The outer tube 602 and inner tube 604 are made of a flexible resin material that can be bent along the curved portion of the intestinal tract, for example. Urethane (polyurethane resin) can be used as an example of a flexible resin material. However, it is not limited to this, and for example, the outer tube 602 and inner tube 604 can be made of a material with an elastic modulus of about 5 to 20 MPa at 100% elongation, as determined by the method described in JIS K7161 (tensile test) or a method equivalent thereto. The thickness of the outer tube 602 and inner tube 604 is, for example, about 100 μm to 200 μm each, and the total thickness of the outer tube 602 and inner tube 604 is about 200 μm to 400 μm. Furthermore, from the standpoint of preventing tearing, it is preferable to make the thickness of the outer tube 602 thicker than that of the inner tube 604.

[0106] The thickness of the internal space 608 located between the outer tube 602 and the inner tube 604 is approximately 600 μm to 800 μm, for example, if the thickness T of the tube body 606 shown in Figure 15 is approximately 1 mm (for example, a maximum of 1 mm). Note that the thicknesses of the outer tube 602, the inner tube 604, and the internal space 608 are not limited to the above thicknesses, but are set based on the diameter of the insertion portion 14 (see Figure 1), the diameter of the insertion path into which the insertion portion 14 is inserted, etc. The inner diameter of the inner tube 604 is also set based on the diameter of the insertion portion 14, and its inner diameter is approximately 6 mm to 16 mm.

[0107] The outer surface of the outer tube 602 and the inner surface of the inner tube 604 each have a hydrophilic coating 610. By forming a hydrophilic coating 610 on the outer surface of the outer tube 602, frictional resistance between the outer tube 602 and the large intestine 500 (see Figure 6) can be reduced. As a result, the ease of insertion (forward movement) of the tube body 606 into the large intestine 500 is improved. Furthermore, by forming a hydrophilic coating 610 on the inner surface of the inner tube 604, frictional resistance between the inner tube 604 and the insertion portion 14 (see Figure 1) can be reduced. As a result, the ease of insertion of the insertion portion 14 into the tube body 606 is improved. In this example, a configuration in which the hydrophilic coating 610 is formed on both the outer tube 602 and the inner tube 604 has been described, but the invention is not limited to this configuration, and the hydrophilic coating 610 may be formed on at least one of the outer tube 602 and the inner tube 604. However, it is preferable to form a hydrophilic coating 610 on both the outer tube 602 and the inner tube 604, as this allows both of the above-mentioned effects to be obtained simultaneously.

[0108] The internal space 608 described above is a space formed in an annular (donut-shaped) manner, with a cross-sectional shape perpendicular to the axis Ax of the guide tube 600, surrounding the periphery (outer circumference) of the inner tube 604, and the shape-adjustable body 612 and intermediate layer 614, which will be described later, are arranged within it.

[0109] As shown in Figure 14, ring-shaped caps 616 and 618 are bonded to the base and tip ends of the tube body 606, respectively, and these caps 616 and 618 seal the outer tube 602 and the inner tube 604. As a result, the internal space 608 is formed as a sealed space. In addition, a pump 38 for supplying and discharging fluid (e.g., air) to the internal space 608 is connected to the cap 616 at the base end of the tube body 606 via piping 40.

[0110] Figure 16 is an enlarged cross-sectional view of the main part of the base end of the guide tube 600 shown in Figure 14. As shown in Figure 16, the cap 616 at the base end of the tube body 606 is bonded to the base end of the outer tube 602 via adhesive 620 and to the base end of the inner tube 604 via adhesive 622. In addition, the base ends of the shape-adjustable body 612 and the intermediate layer 614 are bonded to the cap 616 by adhesive 622.

[0111] Figure 17 is an enlarged cross-sectional view of the main part of the tip side of the guide tube 600 shown in Figure 14. As shown in Figure 17, the cap 618 at the tip side of the tube body 606 is bonded to the tip side of the outer tube 602 via adhesive 624 and to the tip side of the inner tube 604 via adhesive 626. In addition, the tip sides of the shape-adjustable body 612 and the intermediate layer 614 are bonded to the cap 618 by adhesive 626.

[0112] Returning to Figure 16, the base cap 616 has a vent hole 628 that connects the internal space 608 to the piping 40. The piping 40 is connected to the pump 38 via a three-way stopcock 630. The three-way stopcock 630 has a first port 630A connected to the pump 38, a second port 630B connected to the piping 40, and a third port 630C that is open to the atmosphere. The three-way stopcock 630 also has a cock 632, which is an example of a switching member of the present invention. By operating this cock 632, the operator can selectively switch between an ON mode that connects the first port 630A and the second port 630B, and an OFF mode that connects the first port 630A and the third port 630C. When the cock 632 is switched to the ON mode, the pump 38 and the internal space 608 are connected. As a result, air in the internal space 608 is sucked in by the pump 38 and released to the atmosphere, or air (atmosphere) is supplied (flows into) the internal space 608 by the pump 38. Also, when the cock 632 is switched to the OFF mode, the pump 38 is connected to the outside air. As a result, the supply and discharge of air to and from the internal space 608 is stopped. Note that the above switching operation using the three-way stopcock 630 is performed with the pump 38 in a continuously running state, but instead, the above switching operation can also be performed by starting (ON) and stopping (OFF) the pump 38. In this case, the ON and OFF operation of the pump 38 can be operated with a foot switch (not shown), which is another example of a switching member of the present invention. Alternatively, an operation button (not shown) for operating the pump 38 ON and OFF may be provided on the handheld operation unit 16 of the endoscope 12 (see Figure 1). This operation button is an example of a switching means of the present invention.

[0113] Next, the shape-variable body 612 shown in Figures 14 and 15 will be described. The shape-variable body 612 is provided between the outer tube 602 and the inner tube 604 (i.e., in the internal space 608). The shape-variable body 612 can be deformed to conform to the shape of the tube body 606 and has a spiral tube 640 arranged along the axis Ax direction of the tube body 606.

[0114] Figure 18 is an external view of the spiral tube 640. As shown in Figure 18, the spiral tube 640 is formed by spirally winding a strip-shaped member 642 and is provided on the outer circumference of the inner tube 604 (see Figure 14). The spiral tube 640 also has a high-friction surface 644 on the surface (outer circumference, first contact surface) that contacts the intermediate layer 614 (see Figure 14), which will be described later. As a result, when air in the internal space 608 (see Figure 14) is discharged by the pump 38 (see Figure 14), the tube body 606 (see Figure 14) and the spiral tube 640 and the intermediate layer 614 come into close contact and frictionally engage via the high-friction surface 644. Consequently, the shape of the spiral tube 640 (e.g., a curved shape) is maintained in an immovable state, thereby increasing the shape retention force of the tube body 606 when in a high-rigidity state (when hardened). Furthermore, since the spiral tube 640 is flexible in the bending direction, its shape can be deformed into a curved shape, for example, as shown in Figure 19.

[0115] The strip-shaped member 642 of the spiral tube 640 is, for example, made of stainless steel (SUS: Steel Use Stainless). However, it is not limited to this, and any material that can be deformed to conform to the shape of the tube body 606 (e.g., plastic) is applicable. The thickness of the strip-shaped member 642 is preferably 300 μm or less, for example, when the thickness T of the tube body 606 (see Figure 15) is about 1 mm (e.g., a maximum of 1 mm). Examples of the high-friction surface 644 include a resin layer coated with a resin such as urethane coating or silica coating on the outer surface (first contact surface) of the spiral tube 640, a rough surface formed on the first contact surface, or a resin layer coated with resin on a rough surface formed on the first contact surface. When forming the above resin layer, it can be formed by immersing the entire spiral tube 640 in molten resin and drying it. In this case, a resin layer that becomes a high-friction surface is also formed on the surface of the spiral tube 640 that contacts the inner tube 604 (inner surface).

[0116] As described above, when a high-friction surface is formed on the inner circumferential surface of the spiral tube 640, the spiral tube 640 and the inner tube 604 adhere closely together and engage through friction via the high-friction surface. Furthermore, when a high-friction surface is also formed on the outer circumferential surface of the inner tube 604, the spiral tube 640 and the inner tube 604 adhere closely together and engage through their respective high-friction surfaces. In either case, the shape-retaining force of the tube body 606 is further improved. As shown in Figures 16 and 17, the spiral tube 640 configured in this way has its base end and tip ends, each consisting of two turns, bonded to the base end and tip end of the inner tube 604 by adhesives 622 and 626. As a result, the spiral tube 640 is firmly bonded to the inner tube 604.

[0117] Next, the intermediate layer 614 shown in Figure 14 will be described. The intermediate layer 614 is a sheet material 650 provided between the outer tube 602 and the inner tube 604, and is capable of contacting the shape-variable body 612 (spiral tube 640). As an example, this sheet material 650 is placed between the outer tube 602 and the spiral tube 640.

[0118] Figure 20 is a perspective view of the sheet material 650. As shown in Figure 20, the sheet material 650 is formed in a cylindrical shape and is arranged along the axis Ax direction of the tube body 606 (see Figure 14). As a result, the outer surface (first contact surface) of the helical tube 640 (Figure 18) is covered by the sheet material 650. The sheet material 650 also has flexibility that allows it to deform to conform to the shape of the tube body 606 (see Figure 14). Specifically, the sheet material 650 has flexibility while having a higher modulus of elasticity than the outer tube 602 (see Figure 14) and the inner tube 604. This modulus of elasticity will be described later.

[0119] The sheet material 650 is constructed by bending a single rectangular sheet 652 into a cylindrical shape and bonding the two abutted edges together with adhesive 654, as shown in the front view of the sheet material 650 in Figure 21. The form of the sheet material 650 is not limited to a cylindrical shape; for example, the sheet 652 may be bent into a C-shape, or multiple strip-shaped sheets may be inserted between the outer tube 602 and the spiral tube 130. In this example, the sheet material 650 is used as an example for the intermediate layer 614, but it is not limited to this; any material that can contact the shape-variable body 612 (spiral tube 640), such as a mesh or linear member, can also be used. The sheet material 650 used as the intermediate layer 614 will be described below.

[0120] The sheet material 650 is, for example, made of a resin such as urethane. However, it is not limited to this, and for example, an aluminum vapor-deposited film can also be used. An aluminum vapor-deposited film is made by vacuum-depositing (thermocompression bonding) aluminum (aluminum foil) onto the surface of a base film. By using an aluminum vapor-deposited film as the sheet material 650, the rigidity of the sheet material 650 can be increased. In this case, examples of base films include those with heat-sealing properties such as PET (Polyethylene terephthalate) or PE (polyethylene). Furthermore, it is preferable that the elastic modulus of the sheet material 650, as determined by the method described in JIS K7161 (tensile test) or a method equivalent thereto, is higher than that of the outer tube 602 and the inner tube 604. This allows the sheet material 650 to reinforce the outer tube 602 and the inner tube 604. In other words, the tensile strength and tensile rigidity of the tube body 606 are increased by the sheet material 650. As a result, the forward movement of the tube body 606 when it is not cured (flexible) is improved. By using aluminum-metallized film or aluminum foil combined with various cloths and films, it is possible to select a material with the optimal modulus of elasticity.

[0121] The thickness of the sheet material 650 is preferably 300 μm or less, for example, if the thickness of the tube body 606 is about 1 mm (for example, a maximum of 1 mm). However, from the viewpoint of rigidity, it is preferable that it be thicker than the thickness of the outer tube 602 and the inner tube 604. Furthermore, if an aluminum vapor-deposited film is used as the sheet material 650, the rigidity of the sheet material 650 can be changed by changing the base film. As a result, the hardness of the tube body 606 in its uncured state can be tuned to a hardness suitable for the lower digestive tract such as the large intestine, or the upper digestive tract such as the esophagus.

[0122] As shown in Figure 20, the sheet material 650 has a high-friction surface 656 on the surface (inner circumferential surface, second contact surface) that is in contact with the spiral tube 640 (see Figure 17). As a result, when the air in the internal space 608 (see Figure 14) is discharged by the pump 38, the tube body 606 (see Figure 14) and the sheet material 650 come into close contact and frictionally engage via their respective high-friction surfaces 644 and 656. Consequently, the shape of the spiral tube 640 (e.g., a curved shape) is maintained in an immovable state, further enhancing the shape-retaining force of the tube body 606 when in a high-rigidity state (when hardened).

[0123] In this example, we have described a configuration in which high-friction surfaces 644 and 656 are formed on both the first contact surface (outer surface) of the spiral tube 640 and the second contact surface (inner surface) of the sheet material 650. However, the high-friction surfaces may be formed on only one of the contact surfaces, and a configuration in which they are formed only on the second contact surface (inner surface) of the sheet material 650 can also be adopted. Furthermore, while it is preferable to form the high-friction surfaces on the entire surface of either one of the contact surfaces, this is not limited to this, and they may be formed on a part of either one of the contact surfaces. In other words, the high-friction surfaces may be formed on at least a part of either one of the contact surfaces. However, by forming high-friction surfaces 644 and 656 on both contact surfaces (preferably the entire surface of both contact surfaces), the shape retention force of the tube body 606 is improved. The method for forming the high-friction surface 656 is the same as that for the high-friction surface 644. Furthermore, from the viewpoint of ensuring the flexibility of the tube body 606 when it is not cured, the gap between the spiral tube 640 and the sheet material 650 is preferably about 50 μm to 500 μm.

[0124] Furthermore, the high-friction surface may be formed on at least a portion of the outer circumferential surface of the sheet material 650 (preferably the entire outer circumferential surface of the sheet material 650). As a result, the sheet material 650 and the outer tube 602 adhere closely together and frictionally engage via the high-friction surface. Alternatively, the high-friction surface may be formed on at least a portion of the inner circumferential surface of the outer tube 602 (preferably the entire inner circumferential surface of the outer tube 602). As a result, the sheet material 650 and the outer tube 602 adhere closely together and frictionally engage via their respective high-friction surfaces. In either case, the shape-retaining force of the tube body 606 is further improved.

[0125] Next, we will describe an example of the procedure when using the guide tube 600 to guide the insertion section 14 of the endoscope 12 into the large intestine 500 (see Figure 6).

[0126] First, when the tube body 606 and the insertion portion 14 (see Figure 1) inserted through the tube body 606 are inserted along the large intestine 500 (see Figure 6), the insertion portion 14, tube body 606, spiral tube 640, and sheet material 650 are all flexible and are smoothly inserted along the curved shape of the large intestine 500.

[0127] Next, with the tube body 606 aligned with the curved shape of the sigmoid colon 502, the pump 38 is activated to suction air from the internal space 608 through the piping 40. As a result, the outer tube 602 is pressed against the sheet material 650, and the inner tube 604 is pressed against the spiral tube 640. Consequently, the high-friction surface 644 of the spiral tube 640 comes into close contact with the high-friction surface 656 of the sheet material 650, resulting in frictional engagement. This causes the tube body 606 to harden in a shape corresponding to the curved shape of the sigmoid colon 502, and this shape is maintained, improving the insertability of the insertion portion 14 into the sigmoid colon 502. The above example of operation hardens the tube body 606 in a shape corresponding to the curved shape of the sigmoid colon 502, but it is not limited to this example. For example, as another example of operation, the tube body 606 may be hardened with the sigmoid colon 502 in a nearly straight shape.

[0128] Next, the curved portion 20 of the insertion portion 14 is extended forward from the tip opening 10A of the guide tube 100, and the treatment instrument (not shown) is led forward from the treatment instrument outlet (not shown) of the rigid tip portion 18 to begin treatment of the lesion 506 of the transverse colon 504. At this time, since the insertability of the insertion portion 14 into the sigmoid colon 502 is improved by the guide tube 600, the rigid tip portion 18 can be positioned accurately for treatment, and as a result, accurate treatment of the lesion 506 becomes possible.

[0129] As described above, the guide tube 600 according to the seventh embodiment has a shape-changing body 612 between the outer tube 602 and the inner tube 604 that can be deformed to conform to the shape of the tube body 606, thereby improving the insertability of the insertion portion 14 of the endoscope 12.

[0130] Furthermore, the guide tube 600 in this example employs a configuration in which the spiral tube 640 and the sheet material 650 are placed in the internal space 608 located between the outer tube 602 and the inner tube 604, which offers the following advantages. Specifically, the hardness of the tube body 606 when cured is greater than that of a configuration having only the spiral tube 640 (i.e., a configuration without the sheet material 650). As a result, the insertability of the insertion section 14 is further improved. In addition, in the case of a configuration without the sheet material 650, if the spiral tube 640 expands and contracts in the axial Ax direction due to the action of inserting the tube body 606 into the large intestine 500, it may affect the forward movement of the tube body 606. However, with the guide tube 600 in this example, this expansion and contraction can be suppressed by the frictional force between the spiral tube 640 and the sheet material 650. As a result, the forward movement of the tube body 606 when it is not cured is further improved.

[0131] Furthermore, it is preferable that the guide tube 600 in this example also includes the mesh tube 56 shown in Figure 2. This mesh tube 56 can prevent buckling of the tube body 606.

[0132] Furthermore, the above example of operation involves treating the lesion 506 with the tube body 606 inserted into the large intestine 500 in a hardened state only once, but the procedure is not limited to this example. For example, the procedure may be performed by gradually advancing the insertion part 14 and the tube body 606 while changing the state of the tube body 606 inserted into the large intestine 500 between a non-hardened state and a hardened state multiple times. The operation in this case includes the steps of inserting the insertion part 14 into the large intestine 500 (insertion part insertion step), inserting the tube body 606 into the large intestine 500 relative to the insertion part 14 while the tube body 606 with the insertion part 14 inserted is in a non-hardened state (tube body insertion step), advancing the insertion part 14 relative to the tube body 606 while the tube body 606 with the insertion part 14 inserted is in a hardened state (insertion part advancing step), and advancing the tube body 606 relative to the insertion part 14 while the tube body 606 with the insertion part 14 inserted is in a non-hardened state (tube body advancing step). The procedure then includes the step of bringing the rigid tip 18 closer to the lesion 506 and treating the lesion 506 by repeating the above insertion part advancing step and tube body advancing step multiple times. In this operation, as will be described later, the insertion portion 14 has an effective length that is 300 mm or more longer than the total length of the tube body 606, so the practitioner can firmly grasp the flexible portion 22 and perform the insertion operation without the tube body 606 getting in the way.

[0133] Next, some variations of the spiral tube 640, which is the shape-variable body 612, will be described. Figures 22 to 26 show side views of spiral tubes 700, 710, 720, 730, and 740, which are examples of variations of the spiral tube 640.

[0134] Here, the rigidity and flexibility of the spiral tube are governed by the material, thickness t, and width f of the strip members that constitute the spiral tube. For example, if the material is stainless steel, the thickness t is set to about 200 μm to 300 μm, and the width f is set to about 2 mm to 4 mm, the initial rigidity and flexibility required for a spiral tube can be ensured. Furthermore, the maximum curvature when the spiral tube is bent is governed by the winding pitch (spiral pitch) p of the strip members. Looking at the spiral tube 700 of the first modified example shown in Figure 22, the spiral tube 710 of the second modified example shown in Figure 23, and the spiral tube 720 of the third modified example shown in Figure 24, the strip members 702, 712, and 722 of the spiral tubes 700, 710, and 720 are stainless steel, and satisfy the above-mentioned preferred thickness t and width f. Furthermore, since spiral tube 700 has a longer winding pitch p (p>p1>p2) than the other spiral tubes 710 and 720, it can be used, for example, as a guide tube for lower gastrointestinal endoscopes where a large curvature is required. In contrast, spiral tubes 710 and 720 have smaller winding pitches p1 and p2 than spiral tube 700, so they can be used, for example, as guide tubes for upper gastrointestinal endoscopes where a small curvature is acceptable.

[0135] On the other hand, the strip members 732 and 742 of the spiral tube 730 of the fourth modified example shown in Figure 25 and the spiral tube 740 of the fifth modified example shown in Figure 26 are made of stainless steel and satisfy the above-mentioned preferred thickness t and strip width f, and furthermore, their respective winding pitches p3 are equal. Looking at the spiral tubes 730 and 740, the strip member 732 of the spiral tube 730 has bent portions 734 and 736 that are alternately bent toward the base end and tip end of the axis Ax. In contrast, the strip member 742 of the spiral tube 740 has protrusions 744 and 746 that alternately protrude toward the base end and tip end of the axis Ax. Compared to a spiral tube in which a strip-shaped strip member is simply wound spirally, the contact area with the sheet material can be increased with the spiral tube 730 having bent portions 734 and 736 and the spiral tube 740 having protrusions 744 and 746. As a result, the shape retention capacity of the tube body during high-rigidity states (curing) can be further enhanced.

[0136] In the seventh embodiment, the guide tube 600 was described using an example configuration in which an intermediate layer 614 is placed between the outer tube 602 and the shape-changing body 612, but the invention is not limited to this. For example, as shown in the longitudinal cross-sectional view of the guide tube 750 of the eighth embodiment in Figure 27, a configuration in which an intermediate layer 614 is placed between the inner tube 604 and the shape-changing body 612 may be adopted. However, from the viewpoint of ease of assembly of the guide tube 600, a configuration in which the intermediate layer 614 is placed in the wide space between the outer tube 602 and the shape-changing body 612 is preferable to a configuration in which the intermediate layer 614 is placed in the narrow space between the inner tube 604 and the shape-changing body 612, as shown in Figure 14, for example.

[0137] Furthermore, although the seventh embodiment of the guide tube 600 was described using a configuration having a shape-changing body 612 (spiral tube 640) and an intermediate layer 614 as an example, the invention is not limited to this. For example, the invention can also be applied to a guide tube in which a shape-changing body 28 having an articulated ring member 42 (see Figure 2) is incorporated into the configuration of the guide tube 600. In this case, the shape-changing body 28 may be placed between the outer tube 602 and the intermediate layer 614, between the inner tube 604 and the shape-changing body 612, or between the shape-changing body 612 and the intermediate layer 614.

[0138] In the first to eighth embodiments described above, examples were shown in which the tube body 34, 606 is switched between a flexible state and a highly rigid state by supplying and discharging air from the internal spaces 36, 608. However, in the medical device guide device of the present invention, the hardness of the tube body in the flexible state (initial state) and the highly rigid state (hardened state) can be adjusted by changing the material of the joint ring member and the spiral tube. For example, when the joint ring member and the spiral tube are made of polypropylene resin, the hardness can be adjusted by using short fibers or long fibers in the glass fibers contained in the polypropylene resin. In this case, the former hardness will be harder than the latter. Since the hardness of the tube body can be adjusted by changing the material in this way, guide tubes with hardness corresponding to the applicable procedure can be prepared for each applicable procedure.

[0139] The following describes an example of preferred dimensions for the insertion section 14 and the tube body 34, 606 (see Figure 14) of the endoscope 12 shown in Figure 1. First, regarding the inner diameter of the tube body 34, 606 and the outer diameter of the insertion section 14, it is preferable that a clearance is formed between the tube body 34, 606 and the insertion section 14 when the insertion section 14 is inserted into the tube body 34, 606. In other words, if the inner diameter of the tube body 34, 606 is D1 and the outer diameter of the insertion section 14 is D2, it is preferable that D1 > D2. Furthermore, it is more preferable that the above clearance is 4 mm or less, and even more preferable that it is 1 mm or more and 4 mm or less.

[0140] To illustrate with specific dimensions, if the outer diameter of the insertion portion 14 is, for example, 8 mm, then the inner diameter of the tube body 34, 606 is more preferably 12 mm or less, and even more preferably 9 mm or more and 12 mm or less. Also, if the outer diameter of the insertion portion 14 is, for example, 13 mm, then the inner diameter of the tube body 34, 606 is more preferably 17 mm or less, and even more preferably 14 mm or more and 17 mm or less.

[0141] By setting the clearance to 4 mm or less, it is possible to prevent internal tissue (e.g., intestinal wall) from being pinched in the gap between the tube body 34, 606 and the insertion portion 14. In particular, when the tube body 34, 606 is in an unhardened state, it is possible to prevent internal tissue (e.g., intestinal wall) from being pinched in the gap during the process of relatively advancing the tube body 34, 606 relative to the insertion portion 14 (tube body advancement process). Furthermore, by setting the clearance to 1 mm or more, the relative advancement and retraction of the insertion portion 14 relative to the tube body 34, 606 can be performed smoothly.

[0142] Next, regarding the relationship between the length of the insertion portion 14 and the lengths of the tube bodies 34 and 606, it is preferable that the insertion portion 14 has an effective length that is 300 mm or longer than the total length of the tube bodies 34 and 606. Here, the effective length of the insertion portion 14 refers to the length from the base end to the tip of the insertion portion 14.

[0143] To illustrate with specific dimensions, if the total length of the tube body 34, 606 is, for example, 400 mm, it is preferable that the insertion portion 14 has an effective length of 700 mm or more. Also, if the total length of the tube body 34, 606 is, for example, 700 mm, it is preferable that the insertion portion 14 has an effective length of 1000 mm or more.

[0144] By making the effective length of the insertion section 14 at least 300 mm longer than the total length of the tube body 34, 606, the practitioner can securely grasp the flexible section 22 and perform the insertion operation without the tube body 34, 606 getting in the way during the procedure of inserting the tube body 34, 606 and the insertion section 14 into the body cavity. For example, the effective length of the insertion section 14 is 1200 mm. Furthermore, tube bodies 34, 606 with a total length of 400 mm can be used for colonoscopy, while tube bodies 34, 606 with a total length of 700 mm can be used for colon and small intestine examinations.

[0145] Figure 28 is a perspective view of an endoscope device 800 according to a second embodiment of the present invention.

[0146] As shown in Figure 28, the guide tube applied to the endoscope device 800 is a guide tube 600 according to the seventh embodiment shown in Figure 14 with a balloon 802 attached. The endoscope applied to the above endoscope device 800 is an endoscope 12 shown in Figure 1 with a balloon 804 attached to the insertion section 14. The balloon 802 is an example of the body-contacting part of the present invention and an example of the balloon for the tube body of the present invention. The balloon 804 is an example of the balloon for the insertion section of the present invention. In this example, the guide tube is described using a guide tube 600 with a balloon 802 attached as an example, but it is not limited to this, and guide tubes with a balloon 802 attached to guide tubes 10, 60, 70, 80, 90, 100 of the first to sixth embodiments and guide tube 750 of the eighth embodiment are also applicable.

[0147] Figure 29 is a cross-sectional view of the main part of the guide tube 600 into which the insertion portion 14 is inserted. Since the detailed structure of the guide tube 600 has already been explained in Figure 14, the detailed structure of the guide tube 600 is omitted from Figure 29, as is its explanation.

[0148] As shown in Figures 28 and 29, a retractable balloon 802 is detachably attached to the tip of the tube body 606 of the guide tube 600. This balloon 802 is made of an elastic material such as rubber and consists of a central bulge 802A and attachment parts 802B, 802B at both ends. Both attachment parts 802B, 802B are fixed to the outer surface of the tube body 606 by winding thread 806 around them.

[0149] As shown in Figure 29, an air tube 808 is attached to the outer surface of the tube body 606 along axis Ax. The tip of this air tube 808 opens within the bulge section 802A and is formed as an air supply suction port 810. The base end of the air tube 808 is connected to a pump 812 located outside the tube body 606. This pump 812 is a multi-purpose air pump capable of both supplying (pressurizing) and sucking air. When air is supplied from the pump 812 to the air tube 808, air is blown out from the air supply suction port 810, causing the bulge section 802A to expand. Conversely, when air is sucked from the pump 812, air is drawn in through the air tube 808 from the air supply suction port 810, causing the bulge section 802A to contract.

[0150] Here, the tube body 606 is connected to the pump 38 shown in Figure 14 via piping 40, but the pump 812 shown in Figure 29 can be used instead of the pump 38. In this case, for example, as shown in the piping diagram in Figure 30, the pump 812 is connected to the first port 630A of the three-way stopcock 630, the piping 40 is connected to the second port 630B, and the air tube 808 is connected to the third port 630C. The piping 40 is also provided with a valve 634 for opening the internal space 608 (see Figure 14) to the atmosphere and allowing air to flow into the internal space 608.

[0151] When the cock 632 of the three-way stopcock 630 is manually operated to connect the first port 630A and the second port 630B, the pump 812, which has been switched to the suction side, can draw air from the internal space 608 (see Figure 14). This causes the tube body 606 to change from a softened state to a hardened state. In addition, by opening the valve 634, the internal space 608 can be opened to the atmosphere and air can flow into the internal space 608. This causes the tube body 606 to change from a hardened state to a non-hardened state.

[0152] Furthermore, when the cock 632 of the three-way stopcock 630 is manually operated to connect the first port 630A and the third port 630C, the pump 812, which has been switched to the pressurizing side, can blow air out from the air supply suction port 810 (see Figure 29). This causes the bulge section 802A to expand. Also, when the first port 630A and the third port 630C are connected as described above, the pump 812, which has been switched to the suction side, can draw air in from the air supply suction port 810 (see Figure 29). This causes the bulge section 802A to contract.

[0153] Furthermore, the switching operation can be automated instead of manually switching using the three-way stopcock 630. In this case, for example, the piping 40 and the air tube 808 are connected to the pump 812 via separate solenoid valves, and the valve 634 is also configured as a solenoid valve. The opening and closing timing of these solenoid valves and the switching timing of pressurization and suction of the pump 812 can then be controlled by a controller. This makes it possible to automate the above switching operation.

[0154] Returning to Figures 28 and 29, a deflated balloon 804 is detachably attached to the tip of the insertion section 14. This balloon 804 is made of an elastic material such as rubber and consists of a central bulge 804A and attachment sections 804B, 804B at both ends. Both attachment sections 804B, 804B are fixed to the outer surface of the curved section 20.

[0155] As shown in Figure 29, an air tube 814 is inserted into the insertion section 14 along its longitudinal axis G. The tip of this air tube 814 opens onto the outer surface of the curved section 20 located inside the bulge section 804A and is formed as an air supply suction port 816. The base end of the air tube 814 is connected to a pump (not shown) located outside the insertion section 14. Therefore, when air is supplied from the pump to the air tube 814, air is blown out from the air supply suction port 816, causing the bulge section 804A to expand. Conversely, when air is drawn in from the pump, air is drawn in from the air supply suction port 816 through the air tube 814, causing the bulge section 804A to contract. It is preferable to use the pump 812 for balloon 802 as the pump for balloon 804. In this case, by adopting a configuration in which the air tube 814 is connected to the pump 812 via a solenoid valve or the like, air can be supplied to and drawn from balloon 804. By using the pump 812 designed for balloon 802 as the pump for balloon 804, the initial and running costs of the endoscope device 800 can be reduced.

[0156] Next, the operation method of the endoscopic device 800 shown in Figure 28 will be explained with reference to Figures 31 and 32. Figures 31 (XXXIA) to 32 (XXXIIH) illustrate a chronological example of the procedure when the endoscopic device 800 is used as a small bowel endoscope. In Figures 31 and 32, the symbols Q, R, S, U, and Z represent the stomach, pylorus, duodenum, small intestine, and lesion.

[0157] First, with the insertion section 14 inserted into the main tube body 606 and the balloon 804 deflated, the insertion section 14 is inserted into the body. That is, the tip of the insertion section 14 is inserted into the stomach Q through the esophagus from the subject's mouth. Figure 31, XXXIA shows the state in which the tip of the insertion section 14 has been inserted into the stomach Q.

[0158] Next, with the balloon 802 in a deflated state and the tube body 606 in an unhardened state, the tube body 606 is inserted into the body along the insertion section 14. That is, the tip of the tube body 606 is inserted into the stomach Q through the esophagus from the subject's mouth. Figure 31, section XXXIB, shows the state in which the insertion section 14 and the tip of the tube body 606 have been inserted into the stomach Q.

[0159] Next, as shown in XXXIC of Figure 31, the insertion section 14 is advanced relative to the tube body 606, and the tip of the insertion section 14 is inserted into the duodenum S through the pylorus R. XXXIC of Figure 31 shows the insertion section 14 inserted along the curved shape of the duodenum S, with the tip of the insertion section 14 inserted into the ascending portion of the duodenum S.

[0160] Next, as shown in XXXID of Figure 31, the balloon 804 is inflated to fix the insertion part 14 inside the body (insertion part fixing step). XXXID of Figure 31 shows the state in which the balloon 804 is in close contact with the ascending part of the duodenum S and the insertion part 14 is fixed to the duodenum S.

[0161] Next, as shown in XXXIE of Figure 31, with the balloon 802 in a deflated state and the tube body 606 in an unhardened state, the tube body 606 is advanced relative to the insertion section 14 (tube body advancement step). XXXIE of Figure 31 shows the state in which the tube body 606 is inserted along the curved shape of the duodenum S, and the tip of the tube body 606 is inserted up to just before the balloon 804 of the insertion section 14.

[0162] Next, the tube body 606 is changed from an unhardened state to a hardened state. That is, the tube body 606 is hardened by sucking the air inside the internal space 608 (see Figure 14) of the tube body 606 with the pump 812 (see Figure 30). Figure 31, XXXIE shows the tube body 606 hardened to conform to the curved shape of the duodenum S.

[0163] Next, as shown in XXXIF of Figure 31, with the tube body 606 in a hardened state, the balloon 802 is inflated to fix the tube body 606 inside the body (tube body fixing step). XXXIF of Figure 31 shows the state in which the balloon 802 is in close contact with the ascending portion of the duodenum S and the tube body 606 is fixed to the duodenum S.

[0164] Next, as shown in XXXIG of Figure 31, the balloon 804 is deflated. XXXIG of Figure 31 shows the state in which the balloon 804 has deflated and the fixation of the insertion portion 14 to the duodenum S has been released.

[0165] Next, as shown in XXXIH of Figure 31, with the balloon 804 in a deflated state, the insertion section 14 is advanced relative to the tube body 606 (insertion section advancement step). XXXIH of Figure 31 shows the state in which the tip of the insertion section 14 is inserted deep into the small intestine U, following the curved shape of the small intestine U. During the advancement of the insertion section 14, the tube body 606 hardens to conform to the curved shape of the duodenum S, allowing the tip of the insertion section 14 to be stably advanced towards the deep part of the small intestine U.

[0166] Next, as shown in XXXIIA of Figure 32, the balloon 804 is inflated to fix the insertion part 14 inside the body (insertion part fixing step). XXXIIA of Figure 32 shows the state in which the balloon 804 is in close contact with the small intestine U and the insertion part 14 is fixed to the small intestine U.

[0167] Next, as shown in Figure 32 XXXIIB, the balloon 802 is deflated. Figure 32 XXXIIB shows the state in which the balloon 802 has deflated and the fixation of the tube body 606 to the duodenum S has been released.

[0168] Next, the tube body 606 is changed from a hardened state to an unhardened state. That is, the internal space 608 (see Figure 14) of the tube body 606 is opened to the atmosphere, and air is allowed to flow into the internal space 608, thereby softening the tube body 606.

[0169] Next, as shown in XXXIIC of Figure 32, with the balloon 802 in a deflated state and the tube body 606 in an unhardened state, the tube body 606 is advanced relative to the insertion section 14 (tube body advancement step). XXXIIC of Figure 32 shows the state in which the tube body 606 is inserted along the curved shape of the small intestine U, and the tip of the tube body 606 is inserted up to just before the balloon 804 of the insertion section 14.

[0170] Next, as shown in Figure 32 XXXIID, the balloon 802 is inflated to fix the tube body 606 inside the body. Figure 32 XXXIID shows the state in which the balloon 802 is in close contact with the small intestine U and the tube body 606 is fixed to the small intestine U.

[0171] Next, as shown in Figures 32 from XXXIIE to XXXIIF, the tube body 606 and the insertion section 14 are pulled together outward. Figure 32, XXXIIF shows the small intestine U being pulled towards the stomach Q side with balloons 802 and 804 in close contact with the small intestine U. This procedure causes the small intestine U to contract in the longitudinal direction, bringing the lesion Z of the small intestine U closer to the tip of the insertion section 14.

[0172] Next, the tube body 606 is changed from an unhardened state to a hardened state. That is, the tube body 606 is hardened by sucking the air inside the internal space 608 (see Figure 14) of the tube body 606 with the pump 812 (see Figure 30). Figure 32, XXXIIF shows the tube body 606 hardened to conform to the curved shape of the contracted small intestine U.

[0173] Next, as shown in XXXIIG of Figure 32, the balloon 804 is deflated. XXXIIG of Figure 32 shows the state in which the balloon 804 has deflated and the insertion portion 14 has been released from its fixation to the small intestine U.

[0174] Next, as shown in XXXIIH of Figure 32, with the balloon 804 in a deflated state, the insertion section 14 is advanced relative to the tube body 606 (insertion section advancement step). XXXIIH of Figure 32 shows the state in which the tip of the insertion section 14 has been inserted along the curved shape of the small intestine U and has reached the vicinity of the lesion Z. During the advancement of the insertion section 14, the tube body 606 hardens to conform to the curved shape of the small intestine U, allowing the tip of the insertion section 14 to be stably advanced toward the lesion Z.

[0175] Next, when the tip of the insertion section 14 reaches the lesion Z, the balloon 804 is inflated to make it adhere tightly to the small intestine U, thereby fixing the tip of the insertion section 14 to the small intestine U. After this, a treatment instrument (not shown) is inserted from the proximal end of the insertion section 14, and the treatment instrument is led out from the treatment instrument outlet (not shown) at the tip of the insertion section 14 to begin treatment of the lesion Z. During treatment of the lesion Z with the treatment instrument, the tube body 606 is fixed to the small intestine U by the balloon 802, and the tip of the insertion section 14 is fixed to the small intestine U by the balloon 804, so that the tip of the insertion section 14 (rigid tip 18) can be positioned precisely for treatment. As a result, precise treatment of the lesion 506 becomes possible.

[0176] Once the treatment of the lesion Z with the instrument is complete, the balloon 804 of the insertion part 14 is deflated to release its fixation to the small intestine U. The tube body 606 is changed from a hardened state to a non-hardened state, and the balloon 802 is deflated to release the fixation to the small intestine U. After this, the insertion part 14 and the tube body 606 are withdrawn from the body as a single unit. The above is an example of how to operate the endoscope device 800.

[0177] Thus, with an endoscope device 800 that employs a configuration in which a balloon 804 is provided on the insertion section 14 and a balloon 802 is provided on the tube body 606, by selectively performing the steps of inflating and deflating the balloon 804 (first inflation / deflation step), inflating and deflating the balloon 802 (second inflation / deflation step), changing the tube body 606 between a non-hardened state and a hardened state (hardness variable step), and relatively advancing and retracting the insertion section 14 and the tube body 606 (advancing / retracting step), the tip of the insertion section 14 can be stably advanced toward the lesion Z located deep within the small intestine U. Furthermore, it becomes possible to accurately treat the lesion Z with a treatment instrument.

[0178] The above embodiment is a configuration in which the balloon 804 is provided on the endoscope 12 side, but it is not limited to this configuration. For example, a configuration in which the balloon 802 is provided only on the guide tube 600 side without providing the balloon 804 on the endoscope 12 side may also be used. In this configuration (i.e., a configuration in which the balloon 802 is provided only on the guide tube 600 side), the operation method of the endoscope device is basically the same as the operation method shown in Figures 31 and 32, but instead of inflating the balloon 804 provided on the endoscope 12 side, the insertion part 14 can be fixed to the intestinal tract by bending the bending part 20 and hooking the tip (hard tip part 18) onto the intestinal tract, etc.

[0179] The following describes some variations of the balloon for the tube body that is attached to the tube body 606.

[0180] Figure 33 is a cross-sectional view showing the main part of the balloon 820 of the first modified example. This balloon 820 is made of an elastic material such as rubber and consists of two bulging parts 820A and 820B and attachment parts 820C and 820C. The attachment parts 820C and 820C are fixed to the outer surface of the tube body 606, so that bulging part 820A is attached to the tip side of the tube body 606 and bulging part 820B is attached to the base side of the tube body 606.

[0181] As shown in Figure 33, an air tube 822 is attached to the outer surface of the tube body 606 along axis Ax. The tip of this air tube 822 opens within the bulge portion 820B and is formed as an air supply suction port 824. The base end of the air tube 822 is connected to a pump (not shown) located outside the tube body 606. When air is supplied to the air tube 822 from this pump, air is blown out from the air supply suction port 824, causing the bulge portions 820A and 820B to expand. Conversely, when air is drawn in from the pump, air is drawn in through the air tube 822 from the air supply suction port 824, causing the bulge portions 820A and 820B to contract. Even a balloon 820 having two such bulge portions 820A and 820B can be applied as a balloon for the tube body.

[0182] Figure 34 is a cross-sectional view showing the main part of the balloon 830 of the second modified example. This balloon 830 consists of a central bulge 830A and attachment parts 830B, 830B at both ends. The attachment part 830B at the tip is fixed to the inner surface of the tube body 606, and the attachment part 830B at the base is fixed to the outer surface of the tube body 606. With this balloon 830, when the bulge 830A expands, it can expand both radially outward and radially inward of the tube body 606. As a result, the expanded bulge 830A can adhere closely to both the intestinal wall (not shown) and the insertion part 14.

[0183] As shown in Figure 34, an air tube 832 is attached to the outer surface of the tube body 606 along axis Ax. The tip of this air tube 832 opens within the bulge section 830A and is formed as an air supply suction port 834. The base end of the air tube 832 is connected to a pump (not shown) located outside the tube body 606. When air is supplied to the air tube 832 from this pump, air is blown out from the air supply suction port 834, and the bulge section 830A expands. At this time, a part of the bulge section 830A is in close contact with the insertion section 14, preventing internal tissue (e.g., intestinal wall) from being pinched in the gap between the tube body 606 and the insertion section 14. On the other hand, when air is drawn in from the pump, air is drawn in from the air supply suction port 834 through the air tube 832, and the bulge section 830A contracts. Even a balloon 830 having such a bulge section 830A can be applied as a balloon for the tube body.

[0184] Figure 35 is a cross-sectional view showing the main part of the balloon 840 of the third modified example. Before describing the balloon 840, the tube body 606 in this example has a cylindrical body 842 that houses the tube body 606 inside. A space 844 is formed between the tube body 606 and the cylindrical body 842 as a sealed space, and this space 844 is configured as a ventilation passage and connected to a pump (not shown). The balloon 840 is attached to the tip of the cylindrical body 842, and an air supply suction port 846 is formed at the tip of the cylindrical body 842 located within the bulge portion 840A of the balloon 840. As a result, the space 844 and the bulge portion 840A are in communication via the air supply suction port 846. The balloon 840 is attached to the tube body 606 by fixing the attachment portions 840B, 840B at both ends of the bulge portion 840A to the outer surface of the cylindrical body 842.

[0185] As shown in Figure 35, when air is supplied from the pump to the space 844, air is blown out of the air supply suction port 846, and the bulge portion 840A expands. On the other hand, when air is drawn in from the pump, air is drawn in from the air supply suction port 846 through the space 844, and the bulge portion 840A contracts. Thus, even though the balloon 840 is attached to the tip of the cylindrical body 842, it can be used as a balloon for the tube body.

[0186] Figure 36 is a cross-sectional view showing the main parts of the balloon 850 of the fourth modified example. Before describing the balloon 850, the tube body 606 in this example has a cylindrical body 852 that houses the tube body 606 inside. The space 854 between the tube body 606 and the cylindrical body 852 is formed as a sealed space, and this space 854 is configured as a ventilation passage and connected to a pump (not shown). The tip of the cylindrical body 852 is made of an elastic material such as rubber, and this tip is formed as the bulge portion 850A of the balloon 850. The part of the cylindrical body 852 other than the tip that functions as the bulge portion 850A is made of a material that cannot be expanded or contracted (for example, hard plastic).

[0187] According to the balloon 850 shown in Figure 36, when air is supplied from the pump to the space 854, the tip of the cylindrical body 852 (i.e., the bulge portion 850A), shown by the dashed line in Figure 36, expands as shown by the solid line in Figure 36. On the other hand, when air is drawn in from the pump, the air is drawn in through the space 854, and the bulge portion 850A contracts as shown by the dashed line in Figure 36. Even a balloon 850 with a bulge portion 850A formed on the cylindrical body 852 can be applied as a balloon for the main body of a tube.

[0188] Figure 37 is a cross-sectional view showing the main part of the fifth modified balloon 860. Before describing the balloon 860, the tube body 606 in this example has a cylindrical body 862 that houses the tube body 606 inside. A thin-walled portion that functions as the bulge portion 860A of the balloon 860 is formed at the tip of this cylindrical body 862. In addition, a sealed space 866 is formed between the bulge portion 860A and the tube body 606.

[0189] As shown in Figure 37, a multi-lumen tube 864 is formed in the cylindrical body 860 along axis Ax. The tip of this multi-lumen tube 864 opens into a sealed space 866 and is formed as an air intake port 868. The base end of the multi-lumen tube 864 is connected to a pump (not shown).

[0190] According to the balloon 860 shown in Figure 37, when air is supplied from the pump to the multi-lumen tube 864, air is ejected from the air supply suction port 868 into the sealed space 866, and the bulge portion 860A expands as shown by the solid line in Figure 37. On the other hand, when air is drawn in from the pump, air is drawn in from the air supply suction port 868 through the multi-lumen tube 864, and the bulge portion 860A contracts as shown by the dashed line in Figure 37. Thus, even a balloon 860 with a thin-walled bulge portion 860A formed on a cylindrical body 862 can be applied as a balloon for the tube body.

[0191] Figure 38 is a front view showing the balloon 870 of the sixth modified example. Specifically, Figure 38 is a front view of the balloon 870 as seen from the tip side of the tube body 606 towards the tip of the tube body 606.

[0192] As shown in Figure 38, the balloon 870 has four bulging sections 870A, 870B, 870C, and 870D along the outer surface of the tube body 606 at the tip of the tube body 606. Furthermore, the balloon 870 is configured so that each of these bulging sections 870A, 870B, 870C, and 870D can be inflated and deflated independently.

[0193] As shown in Figure 38, the balloon 870 allows the tip of the tube body 606 to be fixed to the intestinal wall by inflating the bulging parts 870A, 870B, 870C, and 870D and bringing them into close contact with the intestinal wall (not shown). Furthermore, by inflating at least one of the bulging parts 870A, 870B, 870C, and 870D and bringing this bulging part into close contact with the intestinal wall (not shown), the orientation of the tip of the tube body 606 can be adjusted. Specifically, for example, if only the bulging part 870A located on the upper side in Figure 38 is inflated and brought into close contact with the intestinal wall, the tip of the tube body 606 can be tilted downwards in Figure 38. In other words, by inflating at least one of the bulging sections 870A, 870B, 870C, and 870D, the tip of the tube body 606 can be tilted in the four directions (up, down, left, and right) as shown in Figure 38. Even a balloon 870 having such bulging sections 870A, 870B, 870C, and 870D can be used as a balloon for the tube body.

[0194] In Figure 38, a balloon 870 having four inflatable sections 870A, 870B, 870C, and 870D is used as an example to illustrate a balloon whose tip direction can be changed, but the invention is not limited to this. In other words, any balloon having at least one of the inflatable sections 870A, 870B, 870C, and 870D is applicable.

[0195] [Other embodiments] In the above embodiment, balloons 802, 820, 830, 840, 850, 860, and 870 were described as internal contact parts that tightly adhere the tip of the tube body 606 to the inside of the body. However, other embodiments of the internal contact parts will be described below with reference to Figures 39 and 40.

[0196] Figure 39 is a perspective view of the main part of the tube body 606 to which another embodiment of the internal contact portion is applied. Figure 40 is a cross-sectional view of the main part of the tube body 606 shown in Figure 39.

[0197] As shown in Figures 39 and 40, the tube body 606 in this example has a cylindrical body 880 that houses the tube body 606 inside, and the internal contact portion 882 of this example is provided at the tip of this cylindrical body 880, that is, at the tip of the tube body 606.

[0198] As shown in Figure 40, a thin-walled portion 884 is formed at the tip of the cylindrical body 880. This thin-walled portion 884 is formed along the circumferential direction of the cylindrical body 880, and a suction port 892, described later, is formed in this thin-walled portion 884. Furthermore, the thin-walled portion 884 has a diameter smaller than the outer diameter of the cylindrical body 880 and larger than the inner diameter of the cylindrical body 880, and a sealed space 886 is formed between this thin-walled portion 884 and the tube body 606.

[0199] As shown in Figure 40, a multi-lumen tube 888 is formed in the cylindrical body 880 along axis Ax. The tip of this multi-lumen tube 888 opens into a sealed space 886 and is formed as an air intake port 890. The base end of the multi-lumen tube 888 is connected to a suction pump (not shown).

[0200] As shown in Figure 39, the suction ports 892 are arranged in multiple locations along the circumferential direction of the thin-walled portion 884. Therefore, the body-contact portion 882 in this example is configured to have suction ports 892 located at the tip of the tube body 606.

[0201] Furthermore, as shown in Figure 40, the body contact portion 882 has a soft sponge member 894 that covers the suction port 892. This sponge member 894 is cylindrical and is attached to the tip of the cylindrical body 880, which is concave due to the formation of a thin-walled portion 884.

[0202] With the internal contact section 882 configured as described above, when air is drawn in from the suction pump, intestinal air is drawn in from the multiple suction ports 892 through the sealed space 866 into the multi-lumen tube 888. This suction action causes the tip of the tube body 606 to adhere tightly to the intestinal wall (not shown) via the cylindrical body 880 (sponge member 894). As a result, the tip of the tube body 606 is fixed inside the body. Thus, even with an internal contact section 882 having suction ports 892, the tip of the tube body 606 can be made to adhere tightly to the body.

[0203] Furthermore, since the internal contact portion 882 of the embodiment has a sponge member 894, the intestinal wall is adsorbed to the suction port 892 via the sponge member 894. This protects the intestinal wall from the peripheral edge (edge ​​portion) of the suction port 892 compared to the case where the intestinal wall is directly adsorbed to the suction port 892. The sponge member 894 is not an essential component, but it is preferable to provide it from the viewpoint of protecting the intestinal wall as described above. This sponge member 894 is an example of a porous anti-entanglement member of the present invention, but instead of the sponge member 894, for example, a rigid (e.g., metal) porous material (e.g., porous metal) may be applied. However, when the tube body 606 is fixed inside the body, the sponge member 904 functions as a cushioning material against the intestinal wall, so it is preferable to apply a rigid porous material.

[0204] In the embodiments described above, an endoscope having an insertion portion was used as the medical instrument guided by the medical instrument guide device of the present invention. However, the invention is not limited to this, and can also be applied to medical treatment instruments such as manipulators.

[0205] The above describes examples of guide devices for medical instruments and endoscope devices according to the present invention, but the present invention may be improved or modified in some way without departing from the spirit of the invention. [Explanation of symbols]

[0206] 1. Endoscope equipment 10 Guide tubes 10A tip opening 12 Endoscopes 14 Insertion part 16. Handheld control unit 18. Hardened tip 20 Curved section 22 Soft part 24 Lighting windows 26 Observation window 28 Shape-changing body 28A Shape-changing body 28B Shape-changing body 28C Shape-changing body 28D Shape-Changing Body 28E Shape-changing body 30 outer tube 32 Inner tube 34 Tube body 36 Interior space 38 pumps 40 Piping 42 Joint ring member 42A Joint ring member 42B Joint ring member 46 Fixing ring member 48 joint fragments 49 Fixed piece 50 piece body 52 Connecting member 54 High friction surface 56 Braided tube 60 Guide tubes 70 Guide tubes 80 Guide tubes 90 Guide tubes 100 guide tubes 104 Spiral tube 106 Strip-shaped member 142 Joint ring member 142A Joint ring member 142B Joint ring member 242 Joint ring member 242A Joint ring member 242B Joint ring member 342 Joint ring member 342A Joint ring member 342B Joint ring member 442 Joint ring member 442A Joint ring member 442B Joint ring member 500 Large intestine 502 Sigmoid colon 504 Transverse colon 506 Lesion 600 Guide Tube 602 Outer tube 604 Inner tube 606 Tube body 608 Interior space 610 Hydrophilic Coating 612 Shape-changing body 614 Middle layer 616 Cap 618 Cap 620 Adhesive 622 Adhesive 624 Adhesive 626 Adhesive 628 Ventilation holes 630 Three-way stopcock 630A Port 1 630B Port 2 630C Port 3 632 Cock 634 valves 640 Spiral tube 642 Strip-shaped member 644 High friction surface 650 sheet material 652 seats 654 Adhesive 656 High friction surface 700 spiral tube 702 Strip-shaped member 710 Spiral tube 712 Strip-shaped member 720 Spiral tube 722 Strip-shaped member 730 Spiral tube 732 Strip-shaped member 734 Bend section 736 Bend section 740 Spiral tube 742 Strip-shaped member 744 Protrusion 746 Protrusion 750 Guide Tube 800 Endoscopes 802 Balloon 802A Bulge 802B Mounting section 804 Balloon 804A Bulge 804B Mounting section 806 thread 808 Air Tube 810 Air supply suction port 812 Pump 814 Air Tube 816 Air supply suction port 820 Balloons 820A bulge 820B Bulge 820C Mounting section 822 Air Tube 824 Air supply suction port 830 Balloons 830A Bulge 830B Mounting section 832 Air Tube 834 Air supply suction port 840 balloons 840A Bulge 840B Mounting section 842 Cylinder 844 Space 846 Air supply suction port 850 balloons 850A bulge 852 Cylinder 854 Space 860 balloons 860A bulge 862 Cylinder 864 Multi-lumen tube 866 Closed space 868 Air supply suction port 870 Balloons 870A Bulge 870B Bulge 870C bulge 870D bulge 880 Cylinder 882 Body contact area 884 Thin-walled section 886 Closed space 888 Multi-Lumen Tube 890 Air intake port 892 Suction port 894 Sponge material A. First joint piece Ax axis a. First articular end region B. Second joint b. Second articular end region D. First joint fragment group E. Second joint fragment group T thickness t thickness f band width G Long axis Q Stomach R pylorus S Duodenum U small intestine Z Lesion

Claims

1. A medical device guide device for guiding medical devices into the body, A tube body having a flexible outer tube and a flexible inner tube disposed inside the outer tube, A shape-changing body provided between the outer tube and the inner tube, which can be deformed to conform to the shape of the tube body, An intermediate layer provided between the outer tube and the inner tube, which is in contact with the shape-variable body, Equipped with, The shape-variable body has a first contact surface and the intermediate layer has a second contact surface that is opposite to the first contact surface, and at least a portion of either the first contact surface or the second contact surface includes a high-friction surface. The shape-changing body has a plurality of joint ring members arranged along the axial direction of the tube body, The aforementioned joint ring member is An annular fixing ring member is provided so as to be able to fix the axial relative position with respect to the outer tube or the inner tube, A plurality of joint pieces extending in a comb-like manner from the fixed ring member to both sides in the axial direction, wherein the plurality of joint pieces are arranged in a circumferential direction around the axial direction, It has, If, among the plurality of joint ring members, adjacent joint ring members in the axial direction are designated as the first joint ring member and the second joint ring member, and the joint piece extending from the first joint ring member toward the second joint ring member is designated as the first joint piece, and the joint piece extending from the second joint ring member toward the first joint ring member is designated as the second joint piece, The first joint piece and the second joint piece are positioned so that their axial positions are offset from each other, and their circumferential positions are offset from each other. A guide device for medical instruments.

2. The intermediate layer is provided between the outer tube and the shape-changing body. A guide device for medical instruments according to claim 1.

3. The intermediate layer is provided between the inner tube and the shape-variable body. A guide device for medical instruments according to claim 1.

4. The high-friction surface is provided on the second contact surface, A guide device for medical devices according to any one of claims 1 to 3.

5. The high-friction surface is provided on the first contact surface, A guide device for medical devices according to any one of claims 1 to 4.

6. The intermediate layer has a higher modulus of elasticity than the outer tube and the inner tube. A guide device for medical devices according to any one of claims 1 to 5.

7. The aforementioned intermediate layer is formed by shaping a sheet material into a cylindrical form. A guide device for medical instruments according to claim 6.

8. The system includes a fluid supply and discharge means for supplying and discharging fluid into the internal space between the outer tube and the inner tube, When the fluid in the internal space is discharged by the fluid supply and discharge means, the shape of the variable-shape body is maintained by frictional engagement between the variable-shape body and the intermediate layer via the high-friction surface. A guide device for medical devices according to any one of claims 1 to 7.

9. The high-friction surface is a resin layer in which resin is coated on one of the contact surfaces. A guide device for medical devices according to any one of claims 1 to 8.

10. The high-friction surface is a rough surface formed on one of the contact surfaces. A guide device for medical devices according to any one of claims 1 to 8.

11. The high-friction surface is a resin layer in which a resin is coated onto a rough surface formed on one of the contact surfaces. A guide device for medical devices according to any one of claims 1 to 8.

12. The shape-changing body has a spiral tube formed by spirally winding a strip-shaped member around the outer circumference of the inner tube. A guide device for medical devices according to any one of claims 1 to 11.

13. If the axial width of the joint ring member is W1 and the axial arrangement pitch of the joint ring member is P, then the following equation P < W1 is satisfied. A guide device for medical devices according to any one of claims 1 to 12.

14. If the axial width of the joint ring member is W1 and the axial arrangement pitch of the joint ring member is P, then the following equation P > W1 is satisfied. A guide device for medical devices according to any one of claims 1 to 12.

15. The plurality of joint pieces arranged in the circumferential direction are arranged at equal intervals along the circumferential direction. A guide device for medical devices according to any one of claims 1 to 14.

16. The plurality of fixing ring members are arranged at equal intervals along the axial direction, A guide device for medical devices according to any one of claims 1 to 15.

17. The joint piece comprises a rectangular piece body formed to be elongated in the axial direction, and a connecting member provided between the piece body and the fixing ring member, which is formed to be narrower than the piece body. A guide device for medical devices according to any one of claims 1 to 16.

18. At least one of the outer circumferential surface of the outer tube and the inner circumferential surface of the inner tube has a hydrophilic coating. A guide device for medical devices according to any one of claims 1 to 17.

19. The aforementioned medical device is an endoscope having an insertion portion that is inserted into the body. A guide device for medical devices according to any one of claims 1 to 18.

20. The internal space located between the outer tube and the inner tube has a switching member that can switch between opening to the atmosphere and inflowing with the atmosphere. A guide device for medical devices according to any one of claims 1 to 19.

21. The tube body has an internal contact portion provided at the tip of the tube body, A guide device for medical devices according to any one of claims 1 to 20.

22. The part that adheres to the body is composed of an expandable and contractible balloon for the tube body, which is positioned at the tip of the tube body. A guide device for medical instruments according to claim 21.

23. The body-contact portion is configured to have a suction port located at the tip of the tube body. A guide device for medical instruments according to claim 21.

24. The body-contact portion has a porous anti-entanglement member that covers the suction port. A guide device for medical instruments according to claim 23.

25. The aforementioned medical device, A medical device guide device according to any one of claims 1 to 24, Equipped with, The aforementioned medical device is an endoscope having an insertion portion that is inserted into the body. Endoscope equipment.

26. The endoscope has a switching means that can switch between opening to the atmosphere and inflowing with the atmosphere to the internal space located between the outer tube and the inner tube. The endoscope apparatus according to claim 25.

27. The insertion portion is insertable into the tube body. When the insertion portion is inserted into the tube body, a clearance is formed between the tube body and the insertion portion to prevent pinching of internal tissue. The endoscopic device according to claim 25 or 26.

28. The clearance is 4 mm or less. The endoscopic device according to claim 27.

29. The insertion portion has an effective length that is 300 mm or longer than the total length of the tube body. The endoscopic device according to any one of claims 25 to 28.

30. The insertion portion has an inflatable and deflated balloon for insertion provided at the tip of the insertion portion. The endoscopic device according to any one of claims 25 to 29.

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