Urethral catheter
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- KANEKA CORP
- Filing Date
- 2025-07-31
- Publication Date
- 2026-06-16
Smart Images

Figure 0007874786000001_ABST
Abstract
Description
Technical Field
[0007]
[0001] The present invention relates to a urethral catheter.
Background Art
[0002] In order to insert and deliver to a desired target site in the human body, a medical device capable of remotely operating the direction of the distal end is used.
[0003] For example, in Patent Document 1, an operating wire is disposed in a dedicated lumen, and a plurality of substantially V-shaped openings are formed at intervals in the longitudinal axis direction, and the opening at a position more distal than the proximal side opens deeper. A bending structure of a medical tube is disclosed.
[0004] Also, for example, Patent Document 2 discloses a tube that bends at a fragile portion formed by providing an outer covering tube or an outer covering film on the outer peripheral surface of a V-shaped opening or an opening.
[0005] Also, for example, Patent Document 3 discloses an endoscopic tube-like treatment tool having an opening that opens deeply in a substantially V shape, an operating wire movable in the longitudinal axis direction is disposed in a single lumen, and when the operating wire is pulled in the proximal direction, the opening bends in a closing direction, and when the operating wire is pushed in the distal direction, the opening further opens and bends.
Prior Art Documents
Patent Documents
[0006]
Patent Document 1
Patent Document 2
Patent Document 3
[0008] Therefore, as disclosed in Patent Documents 1 and 2, it is known that the curved state can be stabilized by providing a dedicated lumen for each of the multiple operating wires. However, a curved structure with multiple openings, multiple operating wires, and their dedicated lumens has the problem of being difficult to manufacture cheaply due to the complexity of the tube structure and the pulling operation mechanism for the operating wires.
[0009] Furthermore, in the case of a curved structure, the lumen inside the body meanders at various angles, and when inserting the tube into a branch opening, if the lumen region where the tube exists is narrow and the distance to the branch opening is short, there was a problem in that it could not be curved sufficiently to the required degree. In addition, there was a problem in that if the tip was curved strongly to obtain a sufficient insertion angle towards the branch opening, there was a risk of damaging the body cavity. Furthermore, there were also problems such as being unable to achieve the desired curved state due to compression from surrounding tissues within the body cavity. For example, in men, because the urethra is greatly bent in the bulbous urethra, if the urethra is narrowed due to tension in the external urethral sphincter or benign prostatic hyperplasia, or if a pseudourethra is formed around the bulbous urethra, there was a problem in that it was difficult to insert the tip of the urethral catheter along the urethral opening to the bladder.
[0010] In other words, a curved structure with multiple openings at different positions along the long axis was not an inexpensive structure that offered superior insertion and delivery capabilities.
[0011] Another structure that allows for remote control of the tip's direction involves providing a deeply V-shaped opening and arranging the control wire in a single lumen to bend the tube. This structure had the advantage of allowing smooth bending through the deeply opened opening. However, when a flexible resin was used as the tube material, there was a problem that the opening and / or weak points would buckle when subjected to compressive force in the longitudinal direction. Furthermore, there was a problem that when force was applied from the outside of the tube, it would easily bend in a direction different from the predetermined bending direction.
[0012] Therefore, as disclosed in Patent Document 3, it is known that buckling can be suppressed and bending can be stabilized by using hard materials such as metal for the operating wire and tube. However, there was a problem that it was not possible to manufacture them cheaply when using hard materials such as metal. Furthermore, there was a problem that it was not possible to manufacture them cheaply when compounded with resin.
[0013] Furthermore, when using a flexible resin as the tube material, a significant change in strength occurs at the transition point between the resin and a hard material such as metal, making it difficult to ensure and adjust the appropriate flexibility between the tip and the bent section.
[0014] Another structure that allows for remote control of the tip's direction involves providing a shallow, roughly V-shaped opening or weak point, and arranging the operating wire in a single lumen to bend the tube. This structure had the advantage of suppressing or solving problems such as buckling and easy bending in a direction different from the opening's direction when using inexpensive and flexible resin as the tube material. However, with a shallow opening or weak point, there was a problem that when bending, the tube wall around the opening or weak point at the bend would protrude outward, potentially damaging the body cavity. [Means for solving the problem]
[0015] The urethral catheter described in this disclosure, which solves the above problems, is as follows: [1] A urethral catheter having a tip, a bent portion, a middle portion, and a proximal portion, arranged from distal to proximal, with longitudinal axis direction and circumferential direction, At least the bent portion has a tube structure consisting of a lumen and a tube wall, and is configured to be bent with the low-rigidity portion facing inward by having an opening and / or a weak portion formed in the tube wall. A urethral catheter further having a bending mechanism that meets the following conditions. <Condition> (1) The distal portion has a portion that is fixed distal to the distal end of the low-rigidity portion, which is the tip portion. (2) It is arranged to be movable in the longitudinal direction. (3) Within a portion of the longitudinal axial direction in which the low-rigidity portion is formed, at least a portion of it is located outside the tube structure. [2] The bending operation member has at least a first bending operation member and a second bending operation member in the said section, The region of the bent portion that is not the low-rigidity portion has a first location and a second location that sandwich the low-rigidity portion in the circumferential direction. The urethral catheter according to [1], wherein the first bending operating member penetrates the tube wall at a first location, and the second bending operating member penetrates the tube wall at a second location. [3] The low-rigidity portion has a distal wide portion, a narrow portion, and a proximal wide portion, and the first and second portions are formed at positions that sandwich the narrow portion, as in [2] the urethral catheter. [4] The urethral catheter according to any one of [1] to [3], wherein the low-rigidity portion is composed of the weak portion, and the bending operating member penetrates the tube wall at the weak portion. [5] The urethral catheter according to any one of [1] to [4], wherein the bending operating member is slidably fixed to the tube wall proximal to the section and on the circumferential side of the location where the low-rigidity portion is located. [6] A urethral catheter according to any one of [1] to [5], wherein a part of the bending operating member is arranged to straddle the outside of the low-rigidity portion in the circumferential direction. [7] The bending operation member is, in order from the proximal side, at least the intermediate portion, the section, the distal end portion, the through portion of the tube structure, the portion outside the bending portion excluding the low-rigidity portion, and the portion arranged via the outside of the low-rigidity portion. The urethral catheter according to [6]. [8] The maximum circumferential length of the low-rigidity portion is 1 / 2 or less of the circumference of the tube structure. The urethral catheter according to any one of claims [1] to [7].
[0016] The medical device according to the embodiment that can solve the above problems is as follows. [9] A medical device comprising a distal end portion, a bending portion, an intermediate portion, and a proximal end portion from the distal side toward the proximal side, The bending portion has a tube structure composed of a lumen and a tube wall, A bending operation member is disposed in the lumen so as to be movable in the longitudinal direction, The tube wall of the bending portion has an opening and / or a fragile portion, The bending operation member is slidably attached to the edge portion of the opening and / or the fragile portion, The distal end portion of the bending operation member is fixed to the distal end portion of the distal end portion or the opening or the distal end portion of the fragile portion, When the bending operation member is pulled proximally and the bending portion is bent in a predetermined bending direction, the bending operation member applies a force and / or displaces the edge portion of the opening and / or the fragile portion from the outside of the tube wall to the inside of the tube wall in the lumen direction so as to suppress the tube wall of the bending portion from protruding in the outer direction. The medical device capable of operating the direction of the distal end portion.
[10] The bending portion, the intermediate portion, and the proximal end portion are composed of a single lumen and a tube wall to form a tube structure, In a cross-section perpendicular to the longitudinal axis direction, In a region near the bending portion side on the distal side of the intermediate portion, the thickness of the tube wall on the side where the bending portion is bent in a predetermined bending direction is thinner than the thickness of the tube wall on the opposite side隔着管腔 of the lumen. The medical device according to [9], wherein when the bending operation member is pulled proximally and the bending portion is bent, the intermediate portion is curved.
[11] The proximal portion has a hand operation portion for performing a bending operation of the bending portion. The proximal end portion of the bending operation member is fixed by the hand operation portion. The medical device according to any one of [9] to
[10] , wherein the hand operation portion has a stopper mechanism for stopping movement of the bending operation member in the longitudinal axis direction.
[12] The total length of the regions occupied by the opening of the tube wall of the bending portion and the tube wall in the circumferential direction of the fragile portion in the tube wall circumferential direction is longer than half of the tube wall circumference. The medical device according to any one of [9] to
[11] , wherein the distal end portion of the bending operation member is continuous with the wall surface of the distal end portion of the tip portion on the side where the bending portion bends in a predetermined bending direction, the wall surface of the distal end portion of the opening portion, or the wall surface of the fragile portion, or is fixed at a position offset in the lumen direction inside the tube wall from the wall.
[13] The total length of the regions occupied by the opening of the tube wall of the bending portion and the tube wall in the circumferential direction of the fragile portion in the tube wall circumferential direction is less than or equal to half of the tube wall circumference. The medical device according to any one of [9] to
[12] , wherein the bending operation member is a bending operation wire.
[14] The medical device according to any one of [9] to
[13] , wherein the distal end portion of the bending operation wire is fixed to the tube wall of the tip portion on the side of the tube wall opposite to the side where the bending portion bends in a predetermined bending direction.
[15] The bending operation wire reciprocally penetrates slidably through the tube wall on the distal side of the intermediate portion on the side opposite to the side where the bending portion bends in a predetermined bending direction. Further, the medical device according to any one of [9] to
[14] , wherein the bending operation wire protrudes outside the tube wall of the intermediate portion.
[16] The bending operation wire is attached in a state of being wound around the outer periphery of the tube wall of the opening and / or the fragile portion of the bending portion. Furthermore, the bending wire is slidably attached to the edge and / or the weak portion of the opening of the bent portion. Furthermore, the medical device according to any one of [9] to
[15] wherein the bending wire penetrates the tube wall of the tip portion on the tube wall side opposite to the side in which the bending portion bends in a predetermined bending direction. [Brief explanation of the drawing]
[0017] [Figure 1] This is a schematic side view of a urethral catheter, which is a medical device according to Example 1 of the present invention. [Figure 2] This is a side perspective view of a bent portion according to Embodiment 1 of the present invention. [Figure 3] Figure 2 is a side perspective view of the bent section when it is bent. [Figure 4] This is a perspective view of a bent portion according to another embodiment of the present invention. [Figure 5] This is a side view of a bent portion in another embodiment of Embodiment 1 of the present invention. [Figure 6] This is a side view of the entire urethral catheter according to Embodiment 2 of the present invention. [Figure 7] Figure 6 is a side view of the entire urethral catheter when the bent section is bent. [Figure 8] This is a cross-sectional view of Figure 6. [Figure 9] This is a side view of another aspect of Figure 6. [Figure 10] Figure 6 shows a perspective view and a perspective view of the area around the bend. [Figure 11] This is a schematic side view of the handheld control unit related to Example 3. [Figure 12] These are perspective views and top views of the bent section related to Example 4. [Figure 13] These are perspective views and top views of a bent section in another embodiment related to Example 4. [Figure 14] This is a schematic side view of the distal side of the tip to the middle portion according to Embodiment 5 of the present invention. [Figure 15]This is a perspective view of the distal side from the tip to the middle portion according to Embodiment 6 of the present invention. [Figure 16] This is a side cross-sectional view of the handheld control unit according to Embodiment 7 of the present invention. [Figure 17] This is a side cross-sectional view of a handheld control unit according to another embodiment of Embodiment 7 of the present invention. [Figure 18] This is a side cross-sectional view of a handheld control unit according to another embodiment of Embodiment 7 of the present invention. [Figure 19] This is a side cross-sectional view of a handheld control unit according to another embodiment of Embodiment 7 of the present invention. [Modes for carrying out the invention]
[0018] The present invention will be described below based on examples, but the present invention is not limited by the following examples, and it is certainly possible to implement it with appropriate modifications within the scope that is consistent with the spirit described above and below, and all such modifications are included within the technical scope of the present invention. In addition, hatching and component reference numerals may be omitted in each drawing for convenience, in which case please refer to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority has been given to helping to understand the features of the present invention.
[0019] Furthermore, embodiments of the present invention will be described below with reference to the drawings. In all drawings, the same reference numerals are used for similar components, and descriptions are omitted as appropriate. The various components of the urethral catheter, which is a medical device according to this embodiment, do not need to be independent entities. It is permissible for multiple components to be formed as a single member, for one component to be formed from multiple members, for one component to be part of another component, for a part of one component to overlap with a part of another component, and so on.
[0020] Unless otherwise specified, the terms used in describing embodiments of the present invention are defined as follows. In the description of the embodiments, the terms "tip" and "proximal" may be used. The tip refers to a predetermined length region of each part of the urethral catheter, including the end on the insertion side (distal end). The proximal section refers to a predetermined length region of each part of the urethral catheter, including the end on the proximal side (proximal end). The axis refers to the central axis along the long axis of the urethral catheter body. The longitudinal section of the urethral catheter refers to the cross-section obtained by cutting the urethral catheter along the axis. The transverse section of the urethral catheter refers to the cross-section obtained by cutting the urethral catheter with a plane perpendicular to the long axis. The long axis direction may be referred to as the "longitudinal axis direction," and the circumferential direction as the "circumferential direction."
[0021] The urethral catheter 1 according to this disclosure, as shown in Figures 1, 12, 13, 14c, and 15, is a urethral catheter 1 having a tip portion 10, a bent portion 20, an intermediate portion 30, and a proximal portion 40 extending from a distal portion 2 to a proximal portion 3, and having a longitudinal axis direction 4 and a circumferential direction 8, wherein at least the bent portion 20 has a tube structure consisting of a lumen 21 and a tube wall 22, and a low-rigidity portion T which is an opening 50 and / or a weak portion 60 is formed in the tube wall 22, so that it is configured to bend with the low-rigidity portion T facing inward, and further has a bending operation member 23 that satisfies the following conditions (1) to (3). <Condition> (1) The distal portion has a part that is fixed distal to the distal end 2 of the tip portion 10, which is the distal end of the low-rigidity portion T. (2) It is positioned so as to be movable in the longitudinal direction 4. (3) Within a section k in the longitudinal axis direction 4 where a low-rigidity section T is formed, at least a portion of it is located outside the tube structure.
[0022] According to the above configuration, by pulling the bending operation member 23, the urethral catheter 1 can be easily bent at the bending portion 20 so that the tip portion 10 can be bent with the low-rigidity portion T facing inward relative to the intermediate portion 30, and the tube wall 22 around the low-rigidity portion T at the bending portion 20 does not protrude outward when bending, which is preferable.
[0023] (Example 1) Figure 1 is a schematic side view of a urethral catheter 1, a medical device. The middle section along the long axis 4 of the urethral catheter 1 has been cut off and omitted. The urethral catheter 1 consists of a tip section 10, a bent section 20, a middle section 30, and a proximal section 40, extending from the distal end 2 to the proximal end 3.
[0024] Figure 2 is a side view of the bent portion 20 of the urethral catheter 1. The bent portion 20 has a tube structure consisting of a lumen 21 and a tube wall 22. A bending operation member 23 is positioned in the lumen 21 so as to be movable in the longitudinal direction 4. The tube wall 22 of the bent portion 20 has an opening 50 and / or a weak portion 60. The bending operation member 23 is slidably attached to the edge 51 of the opening and / or the weak portion 60. The distal end 24 of the bending operation member 23 is fixed to the distal end 52 of the opening. The bent portion 20 bends in a predetermined bending direction 6.
[0025] Figure 3 is a side perspective view of the bent portion 20 when it is bent as shown in Figure 2. When the bending operating member 23 is pulled in the traction direction 5 of the proximal side 3 and the bent portion 20 is bent in a predetermined bending direction 6, the bending operating member 23 acts to apply force and / or displace the edge portion 51 and / or weak portion 60 of the opening 50 from the outside of the tube wall 22 to the inside of the tube wall 22 in the lumen direction 7, thereby suppressing the tube wall 22 of the bent portion 20 from protruding outward, and a urethral catheter 1 that is inexpensive, safe, and has improved insertability and delivery is provided.
[0026] Furthermore, when the bend and tip portions are covered by the narrow internal tube walls, such as blood vessels, the bending angle 26 is preferably 5 degrees to 75 degrees, more preferably 10 degrees to 70 degrees, and most preferably 15 degrees to 65 degrees, from the viewpoint of ensuring high safety, insertability, and delivery. As shown in Figure 2, the angles formed by the distal end 52 (61), the deepest part in the circumferential direction 54, and the proximal end 53 (63) of the opening 50 (vulnerable part 60) of the bend portion 20, which is not bent but is approximately straight, can be specified within a range of -10 degrees to +10 degrees of error added to the bending angle 26.
[0027] With respect to the bending operating member 23 in Figures 2 and 3, from the viewpoint of improving the mobility of the bending operating member 23 within the lumen 21 and manufacturing the urethral catheter 1 at a lower cost, it is preferable that the outer cross-sectional shape of the bending operating member 23 be circular or elliptical in a cross-section perpendicular to the longitudinal axis 4.
[0028] Figure 4 is an oblique view of the opening 50 and / or weak portion 60 of the bent portion 20 of another embodiment of the urethral catheter 1. The tube wall 22 of the bent portion 20 may have one or more openings 50 and / or weak portions 60 in the circumferential direction 8. The weak portion 60 can be formed by reducing the thickness of the tube and / or by using a material softer than the tube wall 22.
[0029] Figures 5a to 5e are side views of the opening 50 and / or fragile portion 60 of the bent portion 20 of another embodiment of the urethral catheter 1. When viewed from the side in a direction perpendicular to the long axis 4, the edge 51 of the opening 50 or the edge 62 of the fragile portion 60 has one of the following shapes, selected from approximately V-shape, approximately U-shape, approximately J-shape, approximately O-shape, or approximately I-shape, as shown in Figures 5a to 5e. Furthermore, as shown in Figures 5c and 5e, the outer diameter of the tube at the distal end 52 of the opening 50 or the distal end 61 of the fragile portion 60 may be smaller than the outer diameter of the tube at the proximal end 53 of the opening 50 or the proximal end 63 of the fragile portion 60. A smaller outer diameter at the distal end 52 of the opening 50 or the distal end 61 of the fragile portion 60 is preferable because it makes insertion and delivery to the target site easier.
[0030] (Example 2) Figures 6 and 7 are side views of the entire urethral catheter 1. Figure 7 shows the state in which the bent portion 20 of the urethral catheter 1 in Figure 6 is bent in a predetermined direction 6. The bent portion 20, intermediate portion 30, and proximal portion 40 of the urethral catheter 1 have a tube structure consisting of a single lumen 21 and a tube wall 22. In a cross-section AA' perpendicular to the longitudinal axis 4, the thickness of the tube wall 22 in the region of the distal side 2 of the intermediate portion 30 near the bent portion 20 is such that the tube wall 22a on the side where the bent portion 20 bends in the predetermined bending direction 6 is thinner than the tube wall 22b on the opposite side separated by the lumen 21. When the bending operating member 23 is pulled in the pulling direction 5 on the proximal side 3, and the bent portion 20 bends, the intermediate portion 30 also curves in conjunction.
[0031] From the perspective of providing an inexpensive device, it is preferable that the material of the tip portion 10 and the bending operation member 23 be the same. Furthermore, if the material of the tip portion 10 and the bending operation member 23 is the same, there is no need to manufacture the tip portion 10 and the bending operation member 23 separately, and it is particularly preferable from the perspective of providing an inexpensive device to manufacture them as a single integrated shape at once. When manufactured as a single integrated shape at once in this way, the distal end portion 24 cannot be clearly defined. In addition, it is preferable that the materials of the tip portion 10 and the bending operation member 23 have good compatibility and / or adhesion. If the composition, type, etc. of the materials of the tip portion 10 and the bending operation member 23 are different, it is preferable that the material used for the bending operation member 23 has superior mechanical properties such as rigidity compared to the material used for the tip portion 10, from the perspective of easily suppressing buckling under tensile operation and longitudinal compressive force applied to the bending portion 20.
[0032] Figure 8 is a cross-sectional view of Figure 6, where Figure 8a is a cross-sectional view of AA' in Figure 6 and Figure 8b is a cross-sectional view of BB' in Figure 6. As shown in Figures 8a and 8b, in the cross-sectional views AA' and BB' perpendicular to the longitudinal axis 4, in the region of the intermediate section 30 near the bent section 20 on the distal side 2, the thickness of the tube wall 22a on the side where the bent section 20 bends in a predetermined bending direction 6 is thinner than the thickness of the tube wall 22b on the opposite side separated by the lumen 21. This structure causes the intermediate section 30 near the bent section 20 to bend in conjunction with the bent section 20, resulting in the outside of the tube wall 22b of the intermediate section 30 pressing against the inside of the lumen, thereby improving the insertability and delivery of the tip section 10 to the target site.
[0033] Furthermore, the cross-section of the bending operating member 23 in Figure 8a is elliptical, and the cross-section of the bending operating member 23 in Figure 8b is a flattened, approximately I-shape, approximately C-shape, arc-shaped, or approximately T-shaped. Although not shown, the cross-section of the distal end 24 of the bending operating member 23 is approximately C-shaped, arc-shaped, or an approximately T-shape including these shapes, or a solid, approximately inverted triangular shape, with the outer diameter of the tube structure of the tip portion 10 or the bending portion 20 offset inward. This cross-sectional shape is particularly preferable because it can suppress buckling at the opening 50 and its edges 51 and / or the weak portion 60 and its edges 62 of the bending portion 20, as well as bending in directions other than the predetermined bending direction 6, when subjected to compressive force in the longitudinal axis direction 4.
[0034] Furthermore, as shown in Figures 7 and 8b, the bending operation member 23 is slidably attached to the edge 51 and / or weak portion 60 of the opening 50 in the longitudinal direction 4. This structure allows the bending operation member 23 to apply force and / or displace the edge 51 and / or weak portion 60 of the opening 50 in the lumen direction 7, from the outside of the tube wall 22 to the inside of the tube wall 22, thereby suppressing the tube wall 22 of the bending portion 20 from protruding outward, improving safety, insertability, and delivery.
[0035] Although not shown in the figures, from the viewpoint of improving the mobility of the bending operating member 23 in the longitudinal axis direction 4 at the lumen 21 and enabling smooth bending operations, it is preferable that the bending operating member 23 changes from a substantially C-shaped or arc-shaped cross-section at the distal end 24 to a circular cross-section as it moves in the proximal direction 3.
[0036] Although not shown in the figures, the opening 50 of the bent portion 20 shown in Figures 6 and 7 may also be a weak portion 60, or the opening 50 and the weak portion 60 may be combined.
[0037] Although not shown in the diagram, the cross-section of the bending operating member 23 may be a tube structure in addition to a solid structure, allowing air to be supplied to the opening 50 of the bending portion 20 and / or the tip portion 10. In the case of such a structure, it can be used, for example, as a lumen for supplying air to the rattle section provided at the tip portion 10 or the bending portion 20 by supplying air. The structure of the rattle section can be a known whistle structure that utilizes so-called air vibrations. If the rattle section is provided at the tip portion 10, air can be supplied to the rattle section via the lumen 21 or the hollow bending member 23 to produce sound.
[0038] Furthermore, if the tip 10 and the bent portion 20 are located in a body cavity region where the tubular space, such as within the stomach, esophagus, digestive tract, and bladder, and the bent portion 20 is approximately straight and the opening 50 is open, then no sound is produced because the air supplied to the tip 10 does not reach it sufficiently. On the other hand, if the bent portion 20 is bent and the opening 50 is closed, the air supplied to the tip 10 reaches it sufficiently and sound is produced. In this way, the position of the tip 10 within the body cavity can be confirmed by determining the sound quality and the direction of the sound from the tip through auditory perception.
[0039] Furthermore, when the tip portion 10 and the bent portion 20 are located in a narrow lumen inside the body, if the bent portion 20 is approximately straight, the opening 50 of the bent portion 20 will be closed by the tight contact with the tube wall, allowing the inhaled air to reach the tip portion 10 sufficiently and produce sound. By listening to the sound quality and determining the direction of the sound from the tip, it is possible to confirm that the catheter is located in a narrow lumen inside the body and to determine the position and direction of the tip portion 10. Thus, a urethral catheter 1 having a rattling part in the tip portion 10 or the bent portion 20 is preferable because it allows for inexpensive and simple confirmation of the position, direction, curvature, and lumen width of the tip portion 10 within the body cavity.
[0040] Furthermore, in order to improve the position, insertion, and delivery of the tip portion 10 within the body cavity, a urethral catheter 1 equipped with an imaging unit at the tip portion 10 that allows for visual confirmation of the condition inside the body cavity is particularly preferred.
[0041] Figure 9 is a side view of an entire aspect of another aspect of Figure 6. In Figure 6, the outer diameters of the tube walls 22 in the intermediate section 30 and the proximal section 40 are the same or tapered and linear. In Figure 9, there is a stepped reduction in diameter section 31 between the outer diameters of the tube walls 22 in the intermediate section 30 and the proximal section 40, with the outer diameter of the tube wall 22 in the intermediate section 30 being smaller than the outer diameter of the tube wall 22 in the proximal section 40. Figure 9 is another aspect of Figure 6, and the behavior, effects, and cross-sections when bent are similar to those described in Figures 7 and 8, and can be easily understood by referring to the differences between the aspects of Figure 6 and Figure 9. Cross-sections CC' and DD' in Figure 9 can be easily understood by referring to the cross-sectional views in Figures 8a and 8b, respectively.
[0042] In the configuration shown in Figure 9, similar to the configuration in Figure 6, when the bent portion 20 bends, the intermediate portion 30 near the bent portion 20 also bends in conjunction, similar to Figure 7, causing the outside of the tube wall 22b of the intermediate portion 30 to press against the inside of the lumen, and similar to the configuration in Figure 6, the insertability and delivery of the tip portion 10 to the target site are improved.
[0043] Although not shown in the illustration, the opening 50 of the bent portion 20 shown in Figure 9 may also be a weak portion 60, or the opening 50 and the weak portion 60 may be combined.
[0044] Figure 10 is a perspective view and a perspective perspective view centered on the bent portion 20 in Figure 6 or Figure 9, including a portion of the distal side 2 of the tip portion 10 and the intermediate portion 30. By referring to Figure 7 as well, the arrangement, structure, and operation of the bent portion 20, the opening 50 and the edge portion 51 and / or the fragile portion 60 and the bending operation member 23 in Embodiment 2 of the present invention can be easily understood.
[0045] (Example 3) Figure 11 is a schematic side view of the proximal control section 41 of the urethral catheter 1. The proximal section 40 of the urethral catheter 1 has a proximal control section 41 for bending the bending section 20. The proximal end 25 of the bending operation member 23 is fixed to the proximal control section 41. The proximal control section 41 has a stopper mechanism 42 that prevents the bending operation member 23 from moving in the longitudinal axis direction 4.
[0046] As the hand-operated unit 41 will be explained and illustrated later, known structures and components such as a ring member 70, an outer cylinder slide member 80, a lever-type member 90, or a screw-type rotating member 100 can be selected and their shapes modified as desired.
[0047] For low-cost manufacturing, a ring member 70 is preferred. When inserting and delivering to a target site, if a compressive force is applied in the longitudinal direction 4 of the urethral catheter 1, and the urethral catheter 1 is pushed in while simultaneously performing a bending operation, an outer cylinder slide member 80 is preferred. If it is necessary to carefully check the straight and bent states of the bent portion 20 by visual inspection and tactile sensation, a lever-type member 90 is preferred. If the bending angle 26 of the bent portion 20 is to be finely adjusted and fixed, and the change between the straight and bent states is to be performed gradually, a screw-type rotating member is particularly preferred from the viewpoint of safety and ease of operation.
[0048] As shown in Figures 2, 3, 6 to 10, the urethral catheter 1 has a total length where the opening 50 of the tube wall 22 of the bent portion 20 and the area of the fragile portion 60 occupy the circumferential length direction 8 of the tube wall is longer than half the circumferential length direction 8. The distal end 24 of the bending operation member 23 is fixed to the wall surface 22d of the tip of the bent portion 20 on the side where it bends in a predetermined bending direction 6, the wall surface of the distal end 52 of the opening 50, or the wall surface of the fragile portion 60, either continuously with the wall or offset in the lumen direction 7, which is inside the tube wall 22.
[0049] Furthermore, as can be seen from Figures 4, 8, and 10, the urethral catheter 1 may have two openings 50 in the circumferential direction 8 of the tube wall 22 of the bent portion 20, and the tube wall 22 and the bending operating member 23 may have a total of three substantially arched or arc-shaped cross-sections in the circumferential direction 8 passing through the two openings 50. These structures are preferable from the viewpoint of being excellent in suppressing buckling and bending in directions other than the predetermined bending direction 6.
[0050] (Example 4) Figures 12 and 13 will be explained below. Figures 12 and 13 are perspective views of the urethral catheter 1, centering on the bent portion 20, and including a part of the distal end 2 of the tip portion 10 and the middle portion 30, with the bending operating member 23 being a wire, and the bending operating wire 27 being visualized. The bent portion 20 in Figure 12 has an opening 50, and the bent portion 20 in Figure 13 has a weak point 60.
[0051] Figures 12a, 12c and 13a, 13c show the bent portion 20 in a nearly straight, unbent state, while Figures 12b, 12d and 13b, 13d show the bent portion 20 bent in a predetermined bending direction 6. Figures 12a, 12b and 13a, 13b are perspective views, and Figures 12c, 12d and 13c, 13d are top perspective views.
[0052] As shown in Figures 12 and 13, the total length of the area occupied by the opening 50 and the fragile portion 60 of the tube wall 22 at the bent portion 20 of the urethral catheter 1 in the circumferential direction 8 of the tube wall 22 is less than half the circumference of the tube wall 22, and the deepest part 54 is shallow.
[0053] As shown in Figure 12, the bending wire 27 of the urethral catheter 1 passes from the lumen 21 side on the inside of the tube wall 22 to the outside of the tube wall 22 at the edge 51 of the opening 50, and the bending wire 27 is slidably attached at the edge 51. When the bending wire 27 is pulled in the pulling direction 5 of the proximal side 3, and the bent portion 20 is bent in a predetermined bending direction 6, the bending wire 27 acts to apply force and / or displace the edge 51 of the opening 50 from the outside of the tube wall 22 to the inside of the tube wall 22 in the lumen direction 7, thereby suppressing the tube wall 22 of the bent portion 20 from protruding outward.
[0054] As shown in Figure 13, the bending wire 27 of the urethral catheter 1 passes back and forth through the weak portion 60, from the lumen 21 side on the inside of the tube wall 22 to the outside of the tube wall 22, so that the bending wire 27 is exposed to the weak portion 60 and is slidably attached. When the bending wire 27 is pulled in the traction direction 5 of the proximal side 3, and the bending portion 20 is bent in a predetermined bending direction 6, the bending wire 27 acts to apply force to the weak portion 60 from the outside of the tube wall 22 to the lumen direction 7 on the inside of the tube wall 22 and / or displace it, thereby suppressing the tube wall 22 of the bending portion 20 from protruding outward. As shown in Figures 12 and 13, the structure of the bending portion 20 and the operation of the bending wire 27 described above make it possible to provide a urethral catheter 1 that is inexpensive, safe, and has improved insertability and delivery.
[0055] Let us explain the urethral catheter 1 shown in Figures 12 and 13. The urethral catheter 1 consists of a tip section 10, a bent section 20, an intermediate section 30, and a proximal section 40, extending from the distal end 2 to the proximal end 3, and has a longitudinal axis direction 4 and a circumferential direction 8 (see Figure 1). At least the bent section 20 has a tube structure consisting of a lumen 21 and a tube wall 22, and a low-rigidity section T, which is an opening 50 and / or a weak section 60, is formed in the tube wall 22, so that it is configured to bend with the low-rigidity section T facing inward, and further has a bending operation member 23 that satisfies the following conditions (1) to (3). Note that this configuration is shown in Figures 14c, 14d and Figure 15This is also applied to the urethral catheter 1 shown. <Condition> (1) The distal portion has a part that is fixed distal to the distal end 2 of the tip portion 10, which is the distal end of the low-rigidity portion T. (2) It is positioned so as to be movable in the longitudinal direction 4. (3) Within a section k in the longitudinal axis direction 4 where a low-rigidity section T is formed, at least a portion of it is located outside the tube structure.
[0056] As shown in Figures 12 to 15, the low-rigidity section T is a collective term for the opening 50 and / or the weak section 60. As shown in Figures 12c to 15c, section k refers to a portion of the longitudinal axis direction 4 of the bending operation member 23 where the low-rigidity section T is formed.
[0057] As shown in Figure 12, the bending operation member 23, which is also the bending operation wire 27, has a first bending operation member 23A and a second bending operation member 23B in at least section k, and in the region of the bending portion 20 that is not the low-rigidity portion T, it has a first location 20a and a second location 20b that sandwich the low-rigidity portion T in the circumferential direction, the first bending operation member 23A penetrates the tube wall 22 at the first location 20a, and the second bending operation member 23B penetrates the tube wall 22 at the second location 20b, which is also a preferred configuration. Furthermore, the low-rigidity portion T has a distal wide portion 50a, a narrow portion 50b, and a proximal wide portion 50c from the distal side 2 to the proximal side 3, and the first location 20a and the second location 20b are formed at positions that sandwich the narrow portion 50b, which is also a preferred configuration.
[0058] The opening 50, which is the low-rigidity section T, preferably has an hourglass or roughly gourd shape in plan view, as shown in Figures 12a and 12c as an example, and has a first location 20a located on the left side when viewed from the proximal side to the distal side, and a second location 20b located on the right side. The first bending operation member 23A, located on the left side when viewed from the proximal side to the distal side, preferably passes through a hole (notation omitted) formed in the first location 20a from the proximal side and upper side to the distal side and lower side. Similarly, the second bending operation member 23B, located on the right side when viewed from the proximal side to the distal side, preferably passes through a hole (notation omitted) formed in the second location 20b from the proximal side and upper side to the distal side and lower side.
[0059] When the bending operating member 23 is pulled proximal to the other side, the tension causes the first and second bending operating members 23A and 23B to displace toward a straight line, thereby causing a force to act in a direction that brings the first and second points 20a and 20b closer together. As a result, as shown in Figures 12b and 12d, it becomes possible to bend the tip portion 10 in a predetermined bending direction 6 (see Figure 12a) while restricting the tube wall 22 from expanding outward at the bending portion 20, which is preferable. Note that "outside of the tube wall 22" refers to the radially outer side of the tube wall 22.
[0060] As shown in Figure 13, for example, the low-rigidity section T is composed of a weak section 60, such as a thinned tube wall 22, and the bending operating wire 27, which is the bending operating member 23, penetrates the tube wall 22 in the weak section 60. More specifically, it is preferable that the bending operating wire 27 arranged in the lumen 21 penetrates the tube wall 22 from the inside to the outside in the proximal half of the weak section 60, and penetrates the tube wall 22 from the outside to the inside in the distal half of the weak section 60.
[0061] When the bending wire 27 is pulled proximally, the bending wire 27, located outside the tube wall 22, exerts a force that pushes the weak portion 60 inward. "Inside the tube wall 22" refers to the radially inward side of the tube wall 22. As a result, as shown in Figures 13b and 13d, it is preferable that the tip portion 10 bends in a predetermined bending direction 6 (see Figure 13a) so that the weak portion 60 is on the inside of the bend, while restricting the tube wall 22 from expanding outward at the bending portion 20. The maximum circumferential length of the low-rigidity portion T is preferably 1 / 2 or less of the circumference of the tube structure, more preferably 3 / 7 or less, 2 / 5 or less, and preferably 1 / 10 or more, 1 / 8 or more, or 1 / 6 or more. This specification regarding the maximum circumferential length of the low-rigidity portion T may also be applied to the urethral catheter 1 shown in Figure 12.
[0062] (Example 5) Figure 14 is a schematic side view of the urethral catheter 1, centering on the bent portion 20, including a part of the distal end 2 of the tip portion 10 and the middle portion 30, and visualizing the bending wire 27 and its distal end portion 28. The bent portion 20 in Figure 14 has an opening 50 and / or a fragile portion 60.
[0063] Figures 14a and 14c show the bent portion 20 in a nearly straight, unbent state, while Figures 14b and 14d show the bent portion 20 bent in a predetermined bending direction 6. Figure 14b shows the bent portion 20 of Figure 14a, and Figure 14d shows the bent portion 20 of Figure 14c. Figure 14c is another embodiment of Figure 14a. Furthermore, the arrangement and structure of the tube walls 22 of the tip portion 10, the bent portion 20, and the intermediate portion 30 can be easily understood by referring to Embodiment 1 in Figure 2, Figure 6, and Embodiment 2 in Figure 7.
[0064] The bent portion 20 of the urethral catheter 1 has a tubular structure consisting of a lumen 21 and a tube wall 22. A bending wire 27 is positioned in the lumen 21 so as to be movable in the longitudinal direction 4. The tube wall 22 of the bent portion 20 has an opening 50 and / or a weak portion 60. The bending wire 27 is slidably attached to the edge 51 of the opening 50 and / or the weak portion 60. The distal end 28 of the bending wire 27 is fixed to the tube wall 22c of the tip portion 10 on the tube wall 22b side opposite to the side in which the bent portion 20 bends in a predetermined bending direction 6.
[0065] As shown in Figures 14a and 14b, the bending wire 27 passes from the lumen 21 side on the inside of the tube wall 22 to the outside of the tube wall 22 at the edge 51 and / or weak portion 60 of the opening 50, and the bending wire 27 is slidably attached to the side portion 64 of the edge 51 and / or weak portion 60. The arrangement, structure, and operation of the bending portion 20, the side portion 64 of the edge 51 and / or weak portion 60 of the opening 50 and / or the bending wire 27 can be easily understood by referring to Embodiment 4 in Figure 12.
[0066] As shown in Figures 14c and 14d, the bending wire 27 passes from the lumen 21 side inside the tube wall 22 to the outside of the tube wall 22 at the edge 51 and / or weak point 60 of the opening 50, and the bending wire 27 is slidably attached at the edge 51 and / or weak point 60. The arrangement, structure, and operation of the bending portion 20, the edge 51 and / or weak point 60 of the opening 50 and the bending wire 27 can be easily understood by referring to Embodiment 4 in Figures 12 and 13.
[0067] As shown in Figures 14c and 14d, the urethral catheter 1 has a bending wire 27 that slidably passes back and forth through the distal tube wall 22b of the intermediate section 30, on the side opposite to where the bending section 20 bends in a predetermined bending direction 6. In addition, the bending wire 27 is exposed on the outside of the tube wall 22b of the intermediate section 30.
[0068] The structure shown in Figure 14 above, and described in Example 5, in which the bending wire 27 is fixed to the tube wall 22c at the tip 10 of the distal end 28 of the bending wire 27, and the structure in which the bending wire 27 passes through the tube wall 22b, is exposed to the outside, and is slidably attached to the tube wall 22b, is a structure that more reliably and efficiently suppresses the tube wall 22 of the bending wire 20 from protruding outward when the bending wire 27 is pulled in the pulling direction 5 on the proximal side 3 and the bending portion 20 is bent in a predetermined bending direction 6, by which the bending wire 27 acts to apply force to and / or displace the edge 51 and / or weak portion 60 of the opening 50 from the outside of the tube wall 22 to the inside of the tube wall 22 in the lumen direction 7, and thus is a structure that more reliably and efficiently suppresses the tube wall 22 of the bending portion 20 from protruding outward. In other words, by using the bending wire 27 shown in Figure 14 and the configuration described in Example 5, it is possible to provide a urethral catheter 1 that is inexpensive, safe, and has improved insertability and delivery.
[0069] Let's explain the urethral catheter 1 shown in Figures 14c and 14d. The bending operation member 23 is slidably fixed to the tube wall 22 on the proximal side 3 of section k and on the opposite side in the circumferential direction from the location where the low-rigidity section T is located. In the example shown in Figure 14c, the bending section 20 has a structure similar to that shown in Figure 13, namely, a portion where the bending operation wire 27, which is the bending operation member 23, penetrates the tube wall 22 and passes outside the low-rigidity section T, such as the weak section 60. The specification regarding the maximum circumferential length of the low-rigidity section T may be applied in the same way as in the case of Embodiment 4 shown in Figure 13.
[0070] Furthermore, in the proximal side of the bent portion 20 in the intermediate portion 30, the bending wire 27 is configured to pass for a predetermined length outside the tube wall 22b on the distal side 2 of the intermediate portion 30, opposite to the side where the bent portion 20 bends in a predetermined bending direction 6. The predetermined length is preferably 2 to 3 times the length over which the bending wire 27 passes outside the tube wall 22 in the bent portion 20, but is not limited to this. In the urethral catheter 1 shown in Figures 14c and 14d, as in the case shown in Figure 13, it is preferable that the tip portion 10 can be bent in a predetermined bending direction 6 (see Figure 14c) so that the fragile portion 60 is on the inside of the bend, while restricting the tube wall 22 from expanding outward in the bent portion 20.
[0071] (Example 6) Figure 15 is a perspective view of the urethral catheter 1, centering on the bent portion 20, including a part of the distal end 2 of the tip portion 10 and the middle portion 30, and visualizing the bending operating member 23, which is a wire bending operating wire 27. The bent portion 20 in Figure 15 has an opening 50. Alternatively, a fragile portion 60 may be provided instead of the opening 20.
[0072] Figures 15a and 15c show the bent portion 20 in a nearly straight, unbent state, while Figures 15b and 15d show the bent portion 20 bent in a predetermined bending direction 6. Figures 15a and 15b are perspective views, and Figures 15c and 15d are top perspective views.
[0073] As shown in Figure 15, the total length of the area occupied by the opening 50 of the tube wall 22 at the bent portion 20 of the urethral catheter 1 in the circumferential direction 8 of the tube wall 22 is less than half the circumference of the tube wall 22, and the deepest part 54 is shallow.
[0074] In another embodiment of the urethral catheter 1, the bending wire 27 is attached by being wrapped around the outer circumference of the tube wall 22 at the opening 50 of the bending portion 20. The bending wire 27 is also slidably attached to the edge 51 of the opening 50 of the bending portion 20. Furthermore, the bending wire 27 slidably penetrates the penetration portion 11 of the tube wall 22c at the tip end on the tube wall 22b side opposite to the side where the bending portion 20 bends in a predetermined bending direction 6. With respect to the bending wire 27, the direction of penetration at the penetration portion 11 of the tube wall 22c at the tip end 10 is such that the direction from the distal end 28 to the proximal end 29 (not shown) of the bending wire 27 is positioned within the lumen 21 from the outside of the tube wall 22c to the inside of the tube wall 22c.
[0075] When the bending wire 27 is pulled in the traction direction 5 of the proximal side 3, and the bending portion 20 is bent in a predetermined bending direction 6, the bending wire 27 acts to apply force to the opening 50 from the outside of the tube wall 22 to the inside of the tube wall 22 in the lumen direction 7 and / or displace it, thereby suppressing the tube wall 22 of the bending portion 20 from protruding outward. The urethral catheter 1 shown in Figure 15 and described as Example 6 can be made cheaper, safer, and have improved insertability and delivery due to the structure of the bending portion 20 and the operation of the bending wire 27 described above.
[0076] Let's explain the urethral catheter 1 shown in Figure 15. In the urethral catheter 1, a portion of the bending wire 27, which is the bending operating member 23, is arranged so as to straddle the outside of the low-rigidity section T in the circumferential direction. The bending wire 27 is arranged in order from the proximal side 3, passing through at least the intermediate section 30, section k, tip section 10 which is the penetration section 11 of the tube structure, the part outside the bending section 20 excluding the low-rigidity section T, the outside of the low-rigidity section T, and further outside the bending section 20 excluding the low-rigidity section T. Furthermore, the maximum circumferential length of the low-rigidity section T is preferably 1 / 2 or less of the circumference of the tube structure, and the specification regarding the maximum circumferential length of the low-rigidity section T may be applied in the same way as in the case of Embodiment 4 shown in Figure 13.
[0077] When the bending wire 27 is pulled towards the proximal side 3, the bending wire 27 is wrapped around the low-rigidity portion T of the tube wall 22. This allows the tip 10 to be bent in a predetermined bending direction 6 (see Figure 15a) so that the tube wall 22 does not spread outward at the bending portion 20, and the low-rigidity portion T is on the inside of the bend, which is preferable. Furthermore, if a force is applied to shorten the circumference of the bending wire 27 in the portion wrapped around the tube wall 22 as the bending wire 27 is pulled towards the proximal side 3, it is preferable to strengthen the restriction of outward spreading of the tube wall 22 at the bending portion 20.
[0078] (Example 7) The following are side cross-sectional views of various embodiments of the hand-operated control unit 41 in Embodiment 3. Figure 16 shows the ring member 70, Figure 17 shows the outer cylinder slide member 80, Figure 18 shows the lever-type member 90, and Figure 19 shows the screw-type rotating member 100. Figures 17b, 18b, and 19b show the state of the hand-operated control unit 41 when the bending control member 23 or bending control wire 27 of Figures 17a, 18a, and 19a is pulled in the pulling direction 5 on the proximal side 3, causing the bending portion 20 to bend in a predetermined bending direction 6. All of these are known or similar structures and can be easily understood by referring to the figures, so a detailed explanation is omitted.
[0079] (Example 8) Although not shown in the diagram, the medical device 1 can be used as an internal component, and the medical device 1 can be inserted from the proximal end of a catheter or the like to form a medical device system. It is preferable to use it as a medical device system when insertion and delivery are insufficient with only the outer tube of a catheter or the like. It is particularly preferable to use it as a medical device system by inserting the medical device 1 into one of the following as the outer tube: a Nelaton catheter, Foley catheter, surgical drainage tube, endoductal catheter, endotracheal tube, or nasogastric tube, which are inexpensive and require improved insertion and delivery. By inserting the medical device 1 into these catheters or tubes, the direction of the tip of these catheters or tubes can be manipulated, thereby improving insertion and delivery at a low cost.
[0080] When used as a medical device system, it is preferable that the proximal end portion 40 of the medical device 1 communicates with the opening 50 and / or lumen 21 of the bent portion 20 so that it can be connected to other medical devices. Examples of other medical devices include drug delivery / infusion circuits, blood transfusion circuits, dialysis circuits, or drainage circuits such as suction / drainage bags.
[0081] Furthermore, it is preferable that the medical device 1 be equipped with a mechanism that allows it to be withdrawn from the proximal end of the outer tube or from a position proximal to the proximal end after the outer tube, which is the catheter or tube, has been inserted and delivered to the target site in the body. Such a mechanism may include, for example, a connector member. Being able to remove the medical device 1 from the body after inserting and delivering the outer tube to the target site in the body is particularly preferable because it reduces damage to the body cavity associated with the placement of the outer tube.
[0082] This embodiment encompasses the following technical concepts. [1] A urethral catheter is a medical device consisting of a tip, a bent section, a middle section, and a proximal section, arranged from distal to proximal. The bent portion has a tube structure consisting of a lumen and a tube wall. A bending operation member is arranged in the lumen so as to be movable in the longitudinal direction. The tube wall of the bent portion has an opening and / or a weak portion. A bending operation member is slidably attached to the edge and / or the fragile portion of the opening, The distal end of the bending operating member is fixed to the tip portion, the distal end of the opening, or the distal end of the fragile portion. When the bending operating member is pulled proximally and the bent portion is bent in a predetermined bending direction, the bending operating member acts to apply force to the edge and / or the weak portion of the opening in the lumen direction, from the outside of the tube wall to the inside of the tube wall, thereby suppressing the tube wall of the bent portion from protruding outward. The urethral catheter whose tip can be directed. [Explanation of Symbols]
[0083] 1. Urethral catheter, medical device 2. Distal side 3. Proximal side 4. Long axis direction, Long axis direction 5 Traction direction 6. Determined bending direction 7 Lumen direction 8 Circumferential direction 10 Tip 11 Penetration of the tube wall at the tip 20. Bending section 20a Location 1 20b Second location 21 lumens 22, 22a, 22b, 22c, 22d Tube walls 23 Bending operation member 23A First bending operation member 23B Second bending operation member 24 Distal end of the bending operation member 25 Proximal end of the bending operation member 26. Angle of flexion 27 Bendable wire rod 28 Distal end of the bending operation wire 29 Proximal end of the bending operation wire 30 Middle section 31 Reduced diameter part 32 Middle and distal end 40 Handheld section 41 Handheld control unit 42 Stopper mechanism 50 openings 50a Distal wide portion 50b narrow part 50c Proximal wide section 51 Edge of the opening 52 Distal end of the opening 53 Proximal end of the opening 54 The deepest part of the opening or weak point 60 Vulnerable parts 61 Distal end of the vulnerable area 62 Edges of the vulnerable area 63 Proximal end of the weak area 70 Ring component 80 Outer cylinder slide member 81 Claw portion / groove portion 90 Lever-type member 91 Crank section 100 Screw-type rotating member 101 Screw part T Low rigidity part k section
Claims
1. A urethral catheter having a tip, a bent section, a middle section, and a proximal section, arranged from distal to proximal, with longitudinal axis direction and circumferential direction, At least the bent portion has a tube structure consisting of a urination lumen and a tube wall, and is configured to be bent with the low-rigidity portion facing inward by having an opening and / or a weak portion formed in the tube wall. A urethral catheter further having a bending mechanism that meets the following conditions. <Conditions> (1) The distal portion has a portion that is fixed distal to the distal end of the low-rigidity portion, which is the tip portion. (2) It is arranged to be movable in the longitudinal direction within the urination lumen. (3) Within a portion of the longitudinal axis direction in which the low-rigidity portion is formed, at least a portion penetrates the tube wall and is located outside the tube wall.
2. The bending operation member has at least a first bending operation member and a second bending operation member in the aforementioned section. The region of the bent portion that is not the low-rigidity portion has a first location and a second location that sandwich the low-rigidity portion in the circumferential direction. The urethral catheter according to claim 1, wherein the first bending operating member penetrates the tube wall at a first location, and the second bending operating member penetrates the tube wall at a second location.
3. The urethral catheter according to claim 2, wherein the low-rigidity portion has a distal wide portion, a narrow portion, and a proximal wide portion, and the first and second portions are formed at positions that sandwich the narrow portion.
4. The urethral catheter according to claim 1, wherein the low-rigidity portion is composed of the weak portion, and the bending operating member penetrates the tube wall at the weak portion.
5. The urethral catheter according to claim 1, wherein the bending operating member is slidably fixed to the tube wall proximal to the section and on the circumferential side of the location where the low-rigidity portion is located.
6. The urethral catheter according to claim 1, wherein a part of the bending operating member is arranged to straddle the outside of the low-rigidity portion in the circumferential direction.
7. The urethral catheter according to claim 6, wherein the bending operating member is arranged in order from the proximal side, at least via the intermediate portion, the section, the tip portion which is the penetration portion of the tube structure, the portion outside the bending portion excluding the low-rigidity portion, and the portion outside the low-rigidity portion.
8. The urethral catheter according to any one of claims 1 to 7, wherein the maximum circumferential length of the low-rigidity portion is 1 / 2 or less of the circumference of the tube structure.