Urethral catheters and connecting parts for urinary catheters

Abstract

To provide a urethral catheter capable of suppressing a kink phenomenon of a shaft, and joining component for the urethral catheter.SOLUTION: A urethral catheter comprises a catheter body 2 including a flexible shaft 6, and a base part 7 connected to the shaft 6, a soft first component 31 formed into a cylindrical shape fitted in the shaft 6 and disposed at a connection part between the shaft 6 and the base part 7, and a hard second component 32 integrally clamping a boundary part 73 of the first component 31 and the base part 7 so as to expose a part of the first component 31 from the shaft 6 as a free portion (a second portion 27) and fixed to the base part 7.SELECTED DRAWING: Figure 17

Description

[Technical Field]

[0001] The present disclosure relates to urinary catheters and interface components for urinary catheters. [Background technology]

[0002] For example, Patent Document 1 discloses a catheter equipped with a strain relief. The strain relief has multiple surrounding portions arranged in the axial direction around the axis, with spaces formed between adjacent surrounding portions, making it flexible as a whole. A protrusion that protrudes toward the tip is formed on the distal end surface of each of the surrounding portions. The protrusion abuts against the opposing surrounding portion to adjust the degree of bending when the strain relief is bent. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 5908270 Summary of the Invention [Problem to be solved by the invention]

[0004] In catheters used in the medical field, stress tends to concentrate at the connection between the flexible shaft and the base, which can lead to shaft kinking (e.g., bending of the shaft). Therefore, an object of the present disclosure is to provide a urinary catheter and a connecting component for a urinary catheter that can suppress the kinking phenomenon of the shaft. [Means for solving the problem]

[0005] A urinary catheter according to one embodiment of the present disclosure includes a catheter body including a flexible shaft having a first end to be placed in the patient's bladder and a second end opposite the first end and having a urinary drainage lumen therein, and a base connected to the second end of the shaft and having a urine inlet path therein that communicates with the urinary drainage lumen, and a connecting part including a soft first part that is cylindrically formed and fitted onto the shaft and that is located at the connection between the shaft and the base, and a hard second part that is fixed to the base and that integrally sandwiches the boundary between the first part and the base so that a portion of the first part is exposed as a free part on the first end side of the shaft.

[0006] According to this configuration, the connection portion between the shaft and the base is covered with the first part of the joining component, so stress generated near the connection portion can be dispersed to the soft first part. This reduces stress concentration at the connection portion between the shaft and the base, preventing the shaft from bending or twisting at the connection portion. As a result, the kinking phenomenon of the shaft can be suppressed. Furthermore, because the second part fixed to the base is made of a hard material, the operability of the base can be prevented from being impaired even after it is attached to the base.

[0007] In a urinary catheter according to one embodiment of the present disclosure, the first part includes a fixing part that is covered by the second part and fixed to the second part, and a flange part extending in the circumferential direction is formed on the outer peripheral surface of the fixing part, and the second part may be formed in a cylindrical shape having a groove on its inner peripheral surface into which the flange part of the fixing part can fit, and may include a first receiving part that receives the fixing part.

[0008] With this configuration, the flange portion of the first component can be fitted into the groove of the second component to position the first component relative to the second component. This prevents the first component from shifting when the boundary between the first component and the base is sandwiched between the second component. As a result, the workability of attaching the joining component to the catheter body can be improved. In a urethral catheter according to one embodiment of the present disclosure, the first part may have a stepped surface inside that faces the base at the boundary between the fixed part and the free part and that abuts against the end of the base on the connection part side.

[0009] With this configuration, when the first part is fitted onto the shaft and moved in the longitudinal direction of the shaft, the completion of positioning of the first part can be confirmed by the abutment of the end of the base against the step surface of the first part. In a urethral catheter according to one embodiment of the present disclosure, the catheter body includes a balloon formed at the first end of the shaft, the shaft has a balloon lumen therein that communicates with the balloon, the base includes a urination base that extends linearly from the connection portion with the shaft and has the urine inlet path, and a balloon base that branches off integrally from the urination base and has a water inlet path therein that communicates with the balloon lumen, and the second part may be formed in a cylindrical shape with a notch that prevents interference with the balloon base and include a second receiving part that receives the urination base.

[0010] According to this configuration, a notch is formed in the second component. This prevents the second component from partially interfering with the balloon base when the boundary between the first component and the base is sandwiched by the second component. Therefore, the joining component of the present disclosure can be suitably used in urethral catheters having a retention balloon for retaining the catheter body in the bladder.

[0011] In a urinary catheter according to one embodiment of the present disclosure, the second component may consist of a pair of first and second members that are separable from each other, and at least the first member may have a claw portion, and the second member may have a hole portion with which the claw portion can engage. With this configuration, the first member and the second member can be easily joined by engaging the claws with the holes. Furthermore, the first member and the second member can be easily separated by releasing the engagement of the claws. Therefore, the workability of attaching and detaching the joining component to and from the catheter body can be improved.

[0012] In a urinary catheter according to one embodiment of the present disclosure, the first member has a first joint surface joined to the second member, the second member has a second joint surface joined to the first joint surface, at least the first joint surface has a protrusion, and the second joint surface may have a recess into which the protrusion is inserted. According to this configuration, the projection is fitted into the recess, thereby making it possible to prevent the first member and the second member from shifting in the lateral direction along their joining surfaces.

[0013] In the urinary catheter according to one embodiment of the present disclosure, the length of the free portion of the first component in the longitudinal direction of the shaft may be not less than 1 cm and not more than 5 cm. In the urinary catheter according to one embodiment of the present disclosure, a first ring extending in a circumferential direction may be formed on an outer peripheral surface of the free portion of the first component. With this configuration, when storing the urinary catheter in a case containing a disinfectant, the opening of the case can be sealed with the first ring, preventing leakage of the disinfectant. Therefore, the first part can be used as a plug for the case.

[0014] A urinary catheter according to one embodiment of the present disclosure may further include a sleeve made of a soft material and having a cylindrical shape fitted onto the shaft so as to be freely movable in the longitudinal direction of the shaft. According to this configuration, when inserting the catheter body into the urethra, the catheter body can be inserted hygienically by grasping the shaft via the sleeve.

[0015] In a urinary catheter according to one embodiment of the present disclosure, a plurality of slits extending along the axial direction of the sleeve are formed on the outer peripheral surface of the sleeve, and may include a long band-shaped portion formed between adjacent ones of the plurality of slits and extending along the axial direction. With this configuration, the sleeve can be contracted along the axial direction by bending the band-shaped portion. For example, after the first end of the shaft reaches the bladder and urination is confirmed, the balloon can be positioned at an appropriate position within the bladder by contracting the sleeve. This prevents the balloon from expanding within the urethra.

[0016] In a urinary catheter according to one embodiment of the present disclosure, the sleeve may include a fitting portion formed at the end of the shaft on the second end side, capable of fitting the free portion of the first component and fixed to the free portion in the fitted state, and a sleeve body formed integrally with the fitting portion and extending from the fitting portion toward the first end side of the shaft.

[0017] According to this configuration, by fitting the free portion of the first component into the fitting portion of the sleeve, the sleeve can also be used as a component for suppressing the kink phenomenon of the shaft. The urinary catheter according to one embodiment of the present disclosure may further include an intermediate portion formed between the fitting portion and the sleeve body, the intermediate portion having a second ring formed on its outer circumferential surface. With this configuration, when storing the urinary catheter in a case containing disinfectant, the opening of the case can be sealed with the second ring, preventing leakage of the disinfectant. Therefore, the sleeve can be used as a stopper for the case.

[0018] In the urinary catheter according to one embodiment of the present disclosure, a rib extending spirally in the circumferential direction may be formed on the outer peripheral surface of the sleeve body. This configuration can prevent the disinfectant from accumulating on the outer peripheral surface of the sleeve body, thereby preventing fingers from slipping on the disinfectant when gripping the sleeve body.

[0019] A connecting part for a urethral catheter according to one embodiment of the present disclosure is a connecting part for a urethral catheter including a catheter body including a flexible shaft having a first end to be placed in the patient's bladder and a second end opposite to the first end, the flexible shaft having a urinary drainage lumen therein, and a base connected to the second end of the shaft and having a urine inlet path therein that communicates with the urinary drainage lumen, the connecting part including: a soft first part formed in a cylindrical shape that can be fitted onto the shaft and that can be placed at the connection between the shaft and the base; and a hard second part that can be fixed to the base by integrally sandwiching the boundary between the first part and the base so that a portion of the first part is exposed as a free portion on the first end side of the shaft.

[0020] According to this configuration, when the connecting part is attached to the catheter body, the connection part between the shaft and the base part is covered by the first part of the connecting part, so stress generated near the connection part can be dispersed to the soft first part. This reduces stress concentration at the connection part between the shaft and the base part, preventing the shaft from bending or twisting at the connection part. As a result, the kinking phenomenon of the shaft can be suppressed. Furthermore, because the second part fixed to the base part is made of a hard material, it is possible to prevent the operability of the base part from being impaired even after attachment to the base part.

[0021] In a connecting part for a urinary catheter according to one embodiment of the present disclosure, when the first part is sandwiched between the second part, the length of the free portion of the first part may be 1 cm or more and 5 cm or less. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a schematic perspective view of a urinary catheter according to one embodiment of the present disclosure. [Figure 2] FIG. 2 is a schematic front view of the urinary catheter. [Figure 3] FIG. 3 is a schematic cross-sectional view of the urinary catheter. [Figure 4] FIG. 4 is a schematic perspective view of the catheter body of FIG. [Figure 5] 5A and 5B are diagrams for explaining the cross-sectional structure of the shaft in FIG. [Figure 6] FIG. 6 is a schematic perspective view of a first part of the joining component. [Figure 7] FIG. 7 is a schematic plan view of the first component. [Figure 8] FIG. 8 is a schematic front view of the first component. [Figure 9] FIG. 9 is a cross-sectional view taken along line IX-IX in FIG. [Figure 10] FIG. 10 is a schematic perspective view of the second part of the joining part. [Figure 11] FIG. 11 is a schematic plan view of the second component. [Figure 12] FIG. 12 is a schematic front view of the second component. [Figure 13] FIG. 13 is a schematic side view of the second component. [Figure 14] FIG. 14 is a diagram for explaining a method of attaching the joining part to the catheter body. [Figure 15] FIG. 15 is a diagram showing the next step in FIG. [Figure 16] FIG. 16 is a diagram showing the next step in FIG. [Figure 17] FIG. 17 is a diagram showing the next step in FIG. [Figure 18] FIG. 18 is a diagram showing the next step in FIG. [Figure 19] FIG. 19 is a schematic perspective view of the sleeve. [Figure 20] FIG. 20 is a schematic plan view of the sleeve. [Figure 21] FIG. 21 is a schematic front view of the sleeve. [Figure 22] FIG. 22 is a cross-sectional view taken along line XXII-XXII in FIG. [Figure 23] FIG. 23 is a schematic perspective view showing a first modified example of the sleeve. [Figure 24] FIG. 24 is a perspective view showing the sleeve of FIG. 23 in a contracted state. [Figure 25] FIG. 25 is a schematic perspective view showing a second modified example of the sleeve. [Figure 26] FIG. 26 is a perspective view showing the sleeve of FIG. 25 in a contracted state. [Figure 27] FIG. 27 is a diagram illustrating how to use a urethral catheter. [Figure 28] FIG. 28 is a diagram showing the next step in FIG. [Figure 29] FIG. 29 is a diagram showing the next step in FIG. [Figure 30] FIG. 30 is a schematic perspective view showing the state of the urinary catheter before it is housed in the disinfection case. [Figure 31] FIG. 31 is a schematic perspective view showing a disinfectant case and a urinary catheter. DETAILED DESCRIPTION OF THE INVENTION

[0023] Next, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. [ Overall configuration of urethral catheter 1 ] Fig. 1 is a schematic perspective view of a urinary catheter 1 according to one embodiment of the present disclosure. Fig. 2 is a schematic front view of the urinary catheter 1. The urinary catheter 1 is a medical device (urethral catheter) used to assist, for example, catheterization in patients who have difficulty urinating. The urinary catheter 1 includes a catheter body 2, a connecting part 3, and a sleeve 4. The urinary catheter 1 is constructed by attaching the connecting part 3 and the sleeve 4 to the catheter body 2. For example, urinary catheterization can be achieved by inserting the tip 5 of the catheter body 2 into the patient's urethra while grasping the sleeve 4 and bringing the tip 5 to the patient's bladder. The urinary catheter 1 according to this embodiment is suitable for use, for example, in self-catheterization, in which the patient operates the catheter body 2 with their own hand to catheterize.

[0024] Below, we will explain in more detail the cross-sectional structure of the urinary catheter 1, as well as the structures of the components of the urinary catheter 1, namely the catheter body 2, the connecting part 3, and the sleeve 4. First, Figure 3 is a drawing commonly used to explain the catheter body 2, the connecting part 3, and the sleeve 4, and is a schematic cross-sectional view of the urinary catheter 1. In Figure 3, part of the relatively long shaft 6 is omitted.

[0025] [ Structure of the catheter body 2 ] Fig. 4 is a schematic perspective view of the catheter main body 2. Fig. 5A and Fig. 5B are diagrams for explaining the cross-sectional structure of the shaft 6 in Fig. 4. 3 to 5A and 5B, the catheter body 2 includes a shaft 6 and a base portion 7. The base portion 7 is made of a polyethylene terephthalate (PET). The shaft 6 is made of, for example, a flexible tube, and has a distal end 6A (first end) that is placed in the patient's bladder, and a proximal end 6B (second end) on the opposite side. The proximal end 6B is the connecting portion with the base 7. A tip 8 is attached to the distal end 6A of the shaft 6. For example, the shaft 6 is inserted into the tip 8 to form a spigot structure, and the two are fixed to each other by welding, gluing, or the like at the mating surfaces of the spigot structure. The tip 8 forms the distal end 5 of the urethral catheter 1.

[0026] In this embodiment, "hardness" and "softness" may be used as one of the characteristics of a component part. "Hardness" and "softness" do not have to be properties defined based on specific quantitative evaluations. For example, "hardness" may be defined as a property of having a degree of hardness that does not deform when the target part is pressed with a finger or dropped. On the other hand, "softness" may be defined as a property of having a degree of hardness that deforms when the target part is pressed with a finger or dropped.

[0027] The shaft 6 and the tip 8 may be constructed by surface-treating a base material made of, for example, a rubber latex base material such as natural rubber latex or synthetic rubber latex, a silicone base material, or a thermoplastic elastomer. Examples of surface treatments include a hydrophilic coating that imparts lubricity to the base material, a urethane coating or fluorine coating that imparts smoothness to the base material, and a silver coating that imparts antibacterial properties to the base material. Two or more of these surface treatments may be used in combination.

[0028] A side hole 9 and a balloon 10 are formed in the distal end 6A of the shaft 6. As shown in FIGS. 5A and 5B, a urinary drainage lumen 11 and a balloon lumen 12 are formed inside the shaft 6, which communicate with the side hole 9 and the balloon 10, respectively. The circumferential surface 13 of the shaft 6 may be smooth as shown in FIG. 5A, or may be uneven as shown in FIG. 5B. In the configuration of FIG. 5B, a plurality of ribs 14 (convex stripes) extending in the longitudinal direction of the shaft 6 form the circumferential surface 13 of the shaft 6 as an uneven surface. These ribs 14 reduce friction when the catheter main body 2 is inserted into or removed from the urethra, thereby reducing discomfort to the patient.

[0029] In this embodiment, the balloon 10 may be integrally formed with the shaft 6. In other words, there may be no connection between the balloon 10 and the shaft 6. Although FIG. 4 shows a boundary 15 between the balloon 10 and the shaft 6, this boundary 15 may not be visible. The base 7 is the part that is operated by the patient or medical staff when urinating or injecting water into the balloon 10, and may also be referred to as an operating part or a hub. Examples of materials for the base 7 include rubber latex such as natural rubber latex and synthetic rubber latex, silicone, and thermoplastic elastomer. The base 7 integrally includes a urination base 16 and a balloon base 17. The base 7 may be formed by branching the balloon base 17 from the circumferential surface of the urination base 16, which extends in line with the shaft 6.

[0030] The urination base 16 is an outlet through which urine guided from the side hole 9 to the urinary drainage lumen 11 is discharged. The urination base 16 is formed in a cylindrical shape and has a urine inlet channel 18 therein that communicates with the urinary drainage lumen 11. The balloon base 17 is an inlet for inflating the balloon 10 with sterile water. The balloon base 17 is formed in a cylindrical shape and has a water inlet channel 19 therein that communicates with the balloon lumen 12. The water inlet channel 19 may be provided with a check valve 20 to prevent backflow of water. A known check valve 20 may be used. For example, the urination base 16 and the balloon base 17 may each be formed in a funnel shape whose outer diameter widens toward the open end. In this case, the urination base 16 and the balloon base 17 may be referred to as a urination funnel and a balloon funnel, respectively.

[0031] The base portion 7 may be fixed to the shaft 6 by, for example, insert molding, welding, adhesive bonding, or the like. In this embodiment, the shaft 6 and the base portion 7 are connected by insert molding of the base portion 7. In insert molding of the base portion 7, the raw material resin of the base portion 7 is filled around the shaft 6, thereby covering a portion of the shaft 6 with the raw material resin of the base portion 7. As a result, as shown in FIG. 3, an overlap portion 21 of the shaft 6 and the base portion 7 exists in a cross-sectional view of the catheter main body 2. Therefore, strictly speaking, the end of the shaft 6 opposite the distal end portion 6A is located inside the base portion 7. However, in this embodiment, as shown in FIG. 4, a portion of the shaft 6 that can be visually distinguished as the boundary portion with the base portion 7 (connection portion 22 between the shaft 6 and the base portion 7) is defined as the base end portion 6B of the shaft 6.

[0032] [ Structure of joining part 3 ] 3, the junction part 3 includes a first part 31 and a second part 32. The junction part 3 is fixed to the catheter body 2 by assembling the first part 31 and the second part 32 to the catheter body 2. The structures of the first part 31 and the second part 32 will be described below, and a method for attaching the junction part 3 to the catheter body 2 will also be described.

[0033] (1) Structure of the first part 31 Fig. 6 is a schematic perspective view of the first component 31. Fig. 7 is a schematic plan view of the first component 31. Fig. 8 is a schematic front view of the first component 31. Fig. 9 is a cross-sectional view taken along line IX-IX in Fig. 7. The first part 31 is a part made of a soft material. Examples of materials for the first part 31 include silicone, vinyl chloride, polyurethane, and thermoplastic elastomer. The first part 31 is formed in a cylindrical shape with one end 23 and the other end 24 open. A through-hole 25 is formed inside the first part 31, reaching from the one end 23 to the other end 24. The first part 31 may include a first portion 26 and a second portion 27. The first portion 26 and the second portion 27 are cylindrical portions separated by a boundary at the middle of the first part 31 in the axial direction (the direction from the one end 23 to the other end 24), and are adjacent to each other in the axial direction and integrally connected.

[0034] The first portion 26 of the first component 31 is formed in a generally cylindrical shape with an outer diameter larger than that of the second component 27. A flange portion 28 is formed on the outer peripheral surface of the first component 26. The flange portion 28 is a convex portion having a constant width that protrudes from the outer peripheral surface of the first component 26 and extends in the circumferential direction of the first component 26. In this embodiment, the flange portion 28 is formed in an annular shape that extends continuously around the entire circumference of the first component 26. More specifically, one annular flange portion 28 is formed on each of both axial end portions of the first component 26. Of the end portions of the first component 26, one end may be the one end portion 23 of the first component 31, and the other end may be a boundary portion 30 with the second component 27.

[0035] The second portion 27 of the first component 31 is formed in a generally cylindrical shape with an outer diameter smaller than that of the first portion 26. A first ring 29 is formed on the outer peripheral surface of the second portion 27. The first ring 29 is formed in an annular shape that extends continuously around the entire circumference of the second portion 27. More specifically, a plurality of first rings 29 (two in this embodiment) are formed in the axial direction of the second portion 27 at intervals from each other.

[0036] The first portion 26 also has a larger inner diameter (diameter of the through hole 25) than the second portion 27. As a result, as shown in FIGS. 7 and 9 , a step surface 35 is formed between the inner circumferential surface 33 of the first portion 26 and the inner circumferential surface 34 of the second portion 27. The step surface 35 is formed at the boundary 30 between the first portion 26 and the second portion 27. The step surface 35 is formed to be inclined from the inner circumferential surface 33 of the first portion 26 toward the inner circumferential surface 34 of the second portion 27, and faces the one end 23 side of the first component 31. The step surface 35 does not need to be an inclined surface and may be, for example, a vertical surface that is perpendicular to the inner circumferential surface 33 of the first portion 26 and the inner circumferential surface 34 of the second portion 27.

[0037] (2) Structure of the second part 32 Fig. 10 is a schematic perspective view of the second part 32. Fig. 11 is a schematic plan view of the second part 32. Fig. 12 is a schematic front view of the second part 32. Fig. 13 is a schematic side view of the second part 32. The second part 32 is a part made of a hard material. Examples of materials for the second part 32 include hard plastic materials such as polyolefin resins such as polyethylene and polypropylene. The second part 32 is made up of a first member 36 and a second member 37 that are separable from each other. The first member 36 and the second member 37 are joined together to form an integrated part, thereby forming the second part 32. In this embodiment, the first member 36 and the second member 37 have the same shape. Therefore, unless otherwise specified, the structure of the first member 36 also applies to the second member 37.

[0038] The first member 36 is formed in a semi-cylindrical shape having one end 38 and the other end 39. The semi-cylindrical first member 36 has a first peripheral edge 42 and a second peripheral edge 43 along the axial direction (the direction from the one end 38 to the other end 39). The second component 32 is assembled by joining the first member 36 and the second member 37 so that the first peripheral edge 42 of the first member 36 faces the second peripheral edge 43 of the second member 37 and the second peripheral edge 43 of the first member 36 faces the first peripheral edge 42 of the second member 37. The first peripheral edge 42 and the second peripheral edge 43 of the first member 36 form a surface to be joined to the second member 37, and therefore may be referred to as a first joining surface. On the other hand, the first peripheral edge 42 and the second peripheral edge 43 of the second member 37 form a surface to be joined to the first member 36, and therefore may be referred to as a second joining surface.

[0039] The first member 36 and the second member 37 are joined by an engagement structure or a fitting structure. More specifically, an engagement structure including claw portions 44 formed on the first member 36 and the second member 37 and hole portions 45 with which the claw portions 44 can be engaged may be applied. Alternatively, a fitting structure including protrusions 46 formed on the first member 36 and the second member 37 and recesses 47 with which the protrusions 46 can be fitted may be applied.

[0040] In this embodiment, the first member 36 and the second member 37 have a symmetrical structure with the axial direction being the axis of symmetry A (see FIG. 12 ), except for the claws 44, holes 45, protrusions 46, and recesses 47. Therefore, if the holes 45 are arranged on the opposite side of the claws 44 and the recesses 47 are arranged on the opposite side of the protrusions 46 in the direction perpendicular to the axis of symmetry A, then by turning the second member 37 upside down and using it, the claws 44 of the first member 36 can be engaged with the holes 45 of the second member 37, and the protrusions 46 of the first member 36 can be fitted into the recesses 47 of the second member 37. In this embodiment, the holes 45 and the protrusions 46 are formed in the first peripheral edge portion 42, and the claws 44 and the recesses 47 are formed in the second peripheral edge portion 43.

[0041] The first member 36 may include a first portion 40 (first receiving portion) and a second portion 41 (second receiving portion). The first portion 40 and the second portion 41 are cylindrical portions of the first member 36 separated by an axial middle portion, and are adjacent to each other in the axial direction and integrally connected. The first portion 40 of the first member 36 is formed in a substantially semi-cylindrical shape with a larger outer diameter than the second portion 41. A stepped surface 51 is formed at the boundary between the first portion 40 and the second portion 41, connecting an inner circumferential surface 49 of the first portion 40 and an inner circumferential surface 50 of the second portion 41. The stepped surface 51 is formed in a flange shape that extends outward from the inner circumferential surface 50 of the second portion 41. A semi-annular protruding portion 52 that protrudes inward from the inner circumferential surface 49 of the first portion 40 is formed at the end (other end 39) of the first portion 40 opposite the second portion 41. As a result, a groove 48 defined by the stepped surface 51, the inner circumferential surface 49, and the protruding portion 52 is formed in the first portion 40 of the first member.

[0042] The second portion 41 of the first member 36 is formed in a generally cylindrical shape with an outer diameter smaller than that of the first portion 40. A cutout portion 53 is formed in the first peripheral edge portion 42 and the second peripheral edge portion 43 of the second portion 41. The cutout portion 53 is formed by removing a long, generally rectangular portion of the first peripheral edge portion 42 and the second peripheral edge portion 43 along the axial direction of the first member 36. When the first member 36 and the second member 37 are joined together, the cutout portion 53 forms an elongated, generally rectangular opening.

[0043] (3) Method of attaching the connecting part 3 to the catheter body 2 14 to 18 are diagrams for sequentially explaining the method of attaching the joining part 3 to the catheter main body 2. FIG. To attach the connecting part 3 to the catheter main body 2, first, referring to Fig. 14, the first part 31 is fitted onto the distal end 6A of the shaft 6 and then moved along the shaft 6 toward the base part 7. This sets the first part 31 in place, as shown in Fig. 15. The first part 31 may be moved, for example, until the connecting part 22 abuts against the stepped surface 35 of the first part 31 (see Fig. 3). This causes the first part 31 to cover the vicinity of the connecting part 22 of the base part 7 and the shaft 6, straddling the connecting part 22 between the base part 7 and the shaft 6.

[0044] 16 and 17, the second component 32 is assembled. First, the first component 36 is prepared, and the flange portion 28 of the first portion 26 of the first component 31 is fitted into the groove 48 of the first component 36. This completes the positioning of the first component 36. The first component 36 covers the first portion 26 of the first component 31 and a portion of the base 7 from below, straddling the boundary 73 between the first component 31 and the base 7.

[0045] When positioning the first member 36, the flange portion 28 is fitted into the groove 48, which prevents the first part 31 from shifting relative to the base 7 when sandwiching the first part 31 between the first member 36 and the second member 37. As a result, the workability of attaching the connecting part 3 to the catheter body 2 can be improved. In addition, because the cutout portion 53 is formed in the second part 41 of the first member 36, the balloon base 17 is prevented from interfering with the first member 36 when fitting the urination base 16 into the first member 36.

[0046] Next, the second member 37 is placed over the first member 36, and with the first part 31 sandwiched between them, the claws 44 are engaged with the holes 45. This engagement causes the protrusions 46 to automatically fit into the recesses 47. Through the above steps, the attachment of the connecting part 3 to the catheter main body 2 is completed, as shown in Figure 18. 18 , the first portion 26 of the first part 31 is fixed to the second part 32 by being sandwiched between the first member 36 and the second member 37. Therefore, the first portion 26 of the first part 31 may be referred to as a fixed portion of the first part 31. Meanwhile, the second part 27 of the first part 31 extends and is exposed from the other end 39 of the second part 32 toward the tip end 6A of the shaft 6, so that the end on the second part 32 side is a fixed end 54 and the opposite end is a free end 55 (other end 24). In other words, the second part 27 of the first part 31 is not fixed to the second part 32, and therefore may be referred to as a free portion of the first part 31. In this embodiment, the length L of the second part 27 in the longitudinal direction of the shaft 6 may be, for example, 1 cm or more and 5 cm or less.

[0047] [ Sleeve 4 structure ] (1) Detailed explanation of sleeve 4 Fig. 19 is a schematic perspective view of the sleeve 4. Fig. 20 is a schematic plan view of the sleeve 4. Fig. 21 is a schematic front view of the sleeve 4. Fig. 22 is a cross-sectional view taken along line XVII-XVII in Fig. 20. The sleeve 4 is a component made of a soft material. Examples of materials for the sleeve 4 include silicone, vinyl chloride, polyurethane, and thermoplastic elastomer. The sleeve 4 is formed in a cylindrical shape with one end 56 and the other end 57 open. A through-hole 58 is formed inside the sleeve 4, reaching from the one end 56 to the other end 57. The sleeve 4 may include a fitting portion 59, a sleeve main body 60, and an intermediate portion 61. The fitting portion 59, the intermediate portion 61, and the sleeve main body 60 are cylindrical portions formed in this order along the axial direction of the sleeve 4 from the one end 56 to the other end 57, and are adjacent to each other in the axial direction and integrally connected.

[0048] The fitting portion 59 of the sleeve 4 is a portion that can be fixed to the first component 31 of the joining component 3. The fitting portion 59 is formed in a substantially cylindrical shape with an outer diameter larger than the sleeve main body 60 and the intermediate portion 61. A second flange portion 62 is formed on the outer peripheral surface of the fitting portion 59. The second flange portion 62 is a convex portion having a constant width that protrudes from the outer peripheral surface of the fitting portion 59 and extends in the circumferential direction of the fitting portion 59. In this embodiment, the second flange portion 62 is formed in an annular shape that extends continuously around the entire circumference of the fitting portion 59. More specifically, a plurality of second flange portions 62 (three in this embodiment) are formed at intervals from each other in the axial direction of the fitting portion 59.

[0049] The sleeve body 60 of the sleeve 4 is formed in a generally cylindrical shape with an outer diameter smaller than that of the fitting portion 59. A rib 63 is formed on the outer peripheral surface of the sleeve body 60. The rib 63 extends spirally in the circumferential direction of the outer peripheral surface of the sleeve body 60. The spiral rib 63 is formed in a single strip shape from one end 64 to the other end 65 without being connected midway. By forming the rib 63 in a spiral shape, it is possible to prevent disinfectant from accumulating on the outer peripheral surface of the sleeve body 60 when using the urinary catheter 1 after disinfection. This makes it possible to prevent fingers from slipping due to the disinfectant when gripping the sleeve body 60.

[0050] The intermediate portion 61 of the sleeve 4 is formed in a generally cylindrical shape with an outer diameter smaller than that of the fitting portion 59 and larger than that of the sleeve main body 60. A second ring 66 is formed on the outer peripheral surface of the intermediate portion 61. The second ring 66 is formed in an annular shape that extends continuously around the entire circumference of the intermediate portion 61. More specifically, a plurality of second rings 66 (two in this embodiment) are formed in the axial direction of the intermediate portion 61 at intervals from each other. The sleeve 4 can be attached to the shaft 6 so as to be movable in the longitudinal direction of the shaft 6 by fitting the sleeve 4 onto the shaft 6 from the tip end 6A of the shaft 6.

[0051] (2) Modification 1 of Sleeve 4 Fig. 23 is a schematic perspective view showing a first modified example of the sleeve 4. Fig. 24 is a perspective view showing the sleeve 4 of Fig. 23 in a contracted state. Referring to Fig. 23, the sleeve 4 may have slits 67 on its outer peripheral surface. In Fig. 23, the slits 67 are formed in place of the ribs 63 of the sleeve main body 60. The slits 67 are formed in an elongated rectangular shape extending along the axial direction of the sleeve 4. A plurality of slits 67 are formed at predetermined intervals along the circumferential direction of the sleeve 4. In Fig. 23, a total of four slits 67 are formed at 90° intervals along the circumferential direction of the sleeve 4. As a result, the sleeve main body 60 is divided into a plurality of band-like portions 68 (four in Fig. 23) formed between adjacent slits 67.

[0052] In this way, since the slits 67 are formed in the sleeve body 60, the sleeve 4 can be contracted in the axial direction by bending the band-shaped portion 68, as shown in FIG.

[0053] (3) Modification 2 of Sleeve 4 Fig. 25 is a schematic perspective view showing a second modified example of the sleeve 4. Fig. 26 is a perspective view showing the sleeve 4 of Fig. 25 in a contracted state. 25, the sleeve 4 may have both slits 67 and ribs 63. For example, the sleeve 4 may have ribs 63 on the outer peripheral surface of the sleeve 4 on the side of the other end 57 relative to the slits 67. In this way, even if the ribs 63 are formed, as long as the slits 67 are formed, the sleeve 4 can be contracted in the axial direction by bending the band-like portions 68, as shown in FIG.

[0054] [ How to use urinary catheter 1 and its effects ] 27 to 29 are diagrams for sequentially explaining how to use the urinary catheter 1. In Fig. 27 to Fig. 29, the sleeve 4 shown in Fig. 23 is used as the sleeve 4. When a patient inserts the urethral catheter 1 into his or her own urethra 69 (self-catheterization), first, as shown in Figure 27, the shaft 6 is inserted into the urethra 69 starting from the tip 8. At this time, the urethral catheter 1 can be inserted hygienically by grasping the shaft 6 via the sleeve 4. When the side hole 9 at the tip of the shaft 6 reaches the bladder 70, urine 71 in the bladder 70 is guided through the side hole 9 into the urinary catheterization lumen 11 (see Figures 5A and 5B). The arrival of urine at the urination base 16 can be confirmed, for example, visually, to know that the side hole 9 has reached the bladder 70.

[0055] Next, as shown in Figure 28, the urethral catheter 1 is inserted a little further. The reason for this is that, as shown in Figure 27, even if the side hole 9 of the urethral catheter 1 has reached the inside of the bladder 70, the balloon 10 may be located inside the urethra 69, and inflating the balloon 10 in this case may damage the urethra 69. The amount of additional insertion of the urethral catheter 1 may be, for example, just enough to bend the band-shaped portion 68 of the sleeve 4 and complete this bending.

[0056] Thereafter, as shown in Figure 29, sterile water is injected into the balloon base 17 using a syringe 72, for example, to inflate the balloon 10 with the sterile water. This fixes the balloon 10 in the bladder 70, preventing the shaft 6 from falling out and leaving the urethral catheter 1 in the bladder 70. Thereafter, urine 71 accumulated in the bladder 70 can be discharged by connecting a urine collection bag or the like to the urination base 16.

[0057] As described above, according to the urinary catheter 1, the connection portion 22 between the shaft 6 and the base portion 7 is covered with the first component 31 of the joining component 3, so that stress generated near the connection portion 22 can be dispersed to the soft first component 31. This prevents stress concentration at the connection portion 22 between the shaft 6 and the base portion 7, thereby preventing the shaft 6 from bending or twisting at the connection portion 22. As a result, the kinking phenomenon of the shaft 6 can be suppressed. Furthermore, because the second component 32 fixed to the base portion 7 is made of a hard material, it is possible to prevent the operability of the base portion 7 from being impaired even after it is attached to the base portion 7.

[0058] Furthermore, when attaching the second part 32, the first member 36 and the second member 37 can be easily joined by engaging the claws 44 with the holes 45. Moreover, the first member 36 and the second member 37 can be easily separated by releasing the engagement of the claws 44. This improves the workability of attaching and detaching the joining part 3 to the catheter body 2. Furthermore, when attaching the second part 32, the protrusions 46 are fitted into the recesses 47, which prevents the first member 36 and the second member 37 from shifting laterally along their joining surfaces.

[0059] 30, after the urethral catheter 1 has been placed in the bladder 70, the flexible sleeve 4 can be used as a component for suppressing kinking of the shaft 6 by fitting the fitting portion 59 of the sleeve 4 into the second portion 27 of the first part 31. Moreover, the first ring 29 is formed on the second part 27 and is in close contact with the inner circumferential surface of the sleeve 4, which also prevents the sleeve 4 from becoming easily detached from the first part 31.

[0060] Furthermore, since the second ring 66 is formed around the periphery of the middle portion 61 of the sleeve 4, as shown in FIG. 31 , when the urinary catheter 1 is placed in a disinfection case 74 for disinfection and storage, the opening 75 of the disinfection case 74 can be sealed with the second ring 66. This makes it possible to prevent leakage of disinfectant. In other words, the sleeve 4 can be used as a stopper for the disinfection case 74. Note that the first part 31 can also be used as the stopper for the disinfection case 74 instead of the sleeve 4. As with the sleeve 4, the first ring 29 is formed on the first part 31 (second portion 27), and the first ring 29 seals the opening 75 of the disinfection case 74.

[0061] Although the embodiments of the present disclosure have been described, the present disclosure may be embodied in other forms. For example, the embodiments of the present disclosure are illustrative in all respects and should not be construed as limiting, and are intended to include modifications in all respects. [Explanation of symbols]

[0062] 1: Urethral catheter 2: Catheter body 3: Joint parts 4: Sleeve 5:Tip 6: Shaft 6A:Tip 6B: Proximal end 7: Base 8: Tip 9: Side hole 10: Balloon 11: Catheterization lumen 12: Balloon lumen 13: Peripheral surface 14: Rib 15: Boundary 16: Base for urination 17: Balloon base 18 :Urine introduction tract 19:Water introduction channel 20: Check valve 21: Overlapped section 22: Connection part 23:One end 24:Other end 25:Through hole 26 :1st part 27:Second part 28: Flange part 29: First Ring 30: Boundary 31: First part 32: Second part 33: Inner peripheral surface 34: Inner peripheral surface 35: Step surface 36: First member 37: Second member 38:One end 39:Other end 40: 1st part 41:Second part 42: First peripheral portion 43: Second peripheral part 44: Claw part 45: Hole 46: Protrusion 47: Recess 48: Groove 49: Inner surface 50: Inner surface 51: Step surface 52: Protruding part 53: Notch 54: Fixed end 55: Free end 56:One end 57:Other end 58:Through hole 59: Fitting part 60: Sleeve body 61: Middle section 62: Second flange 63: Rib 64:One end 65:Other end 66: Second Ring 67: Slit 68: Belt 69: Urethra 70: Bladder 71 :Urine 72: Syringe 73: Boundary 74: Disinfection case 75: Opening A: Axis of symmetry

Claims

1. a catheter body including a flexible shaft having a first end to be placed in the patient's bladder and a second end opposite to the first end, the flexible shaft having a urinary drainage lumen therein, and a base portion connected to the second end of the shaft and having a urine introduction path therein that communicates with the urinary drainage lumen; a connecting part including a flexible first part formed in a cylindrical shape and fitted onto the shaft and arranged at the connection part between the shaft and the base part, and a rigid second part fixed to the base part, which integrally sandwiches the boundary part between the first part and the base part so that a part of the first part is exposed as a free part on the first end side of the shaft.

2. the first component includes a fixing portion that is covered by the second component and fixed to the second component, and a flange portion that extends in a circumferential direction is formed on an outer peripheral surface of the fixing portion, 2. The urinary catheter according to claim 1, wherein the second part includes a first receiving portion that is formed in a cylindrical shape and has a groove on its inner surface into which the flange portion of the fixing portion can be fitted, and that receives the fixing portion.

3. 3. The urinary catheter according to claim 2, wherein the first component has a stepped surface therein that faces the base portion at the boundary between the fixed portion and the free portion and that abuts against an end of the base portion on the connection portion side.

4. the catheter body includes a balloon formed at the first end of the shaft; the shaft has a balloon lumen therein that communicates with the balloon; the base includes a urination base that extends linearly from the connection portion with the shaft and has the urine inlet channel, and a balloon base that branches off integrally from the urination base and has a water inlet channel therein that communicates with the balloon lumen, The urethral catheter according to any one of claims 1 to 3, wherein the second part is formed in a cylindrical shape with a notch that prevents interference with the balloon base, and includes a second receiving part that receives the urination base.

5. the second component comprises a pair of first and second members that are separable from each other; The urinary catheter according to any one of claims 1 to 4, wherein at least the first member has a claw portion, and the second member has a hole portion with which the claw portion can engage.

6. the first member has a first bonding surface to be bonded to the second member, and the second member has a second bonding surface to be bonded to the first bonding surface; The urinary catheter according to claim 5 , wherein at least the first joint surface has a protrusion, and the second joint surface has a recess into which the protrusion is inserted.

7. The urinary catheter according to any one of claims 1 to 6, wherein the length of the free portion of the first component in the longitudinal direction of the shaft is 1 cm or more and 5 cm or less.

8. The urinary catheter according to any one of claims 1 to 7, wherein a first ring extending in the circumferential direction is formed on the outer peripheral surface of the free portion of the first component.

9. 5. The urinary catheter according to claim 4, further comprising a cylindrical sleeve made of a soft material fitted on the shaft so as to be movable in the longitudinal direction of the shaft.

10. A plurality of slits extending along the axial direction of the sleeve are formed on the outer peripheral surface of the sleeve, The urinary catheter according to claim 9, further comprising a band-shaped portion formed between adjacent ones of the plurality of slits and elongated along the axial direction.

11. 11. The urinary catheter according to claim 9, wherein the sleeve includes a fitting portion formed at an end of the shaft on the second end side, into which the free portion of the first component can be fitted and which is fixed to the free portion in the fitted state, and a sleeve body extending toward the first end side of the shaft.

12. The urinary catheter according to claim 11, further comprising an intermediate portion formed between the fitting portion and the sleeve body, the intermediate portion having a second ring formed on its outer circumferential surface.

13. The urinary catheter according to claim 11 or 12, wherein a rib extending spirally in the circumferential direction is formed on the outer peripheral surface of the sleeve body.

14. A connecting part for a urinary catheter, comprising: a catheter body including a flexible shaft having a first end to be placed in the patient's bladder and a second end opposite to the first end, the flexible shaft having a urinary drainage lumen therein; and a base portion connected to the second end of the shaft and having a urine introduction channel therein that communicates with the urinary drainage lumen, A connecting part for a urinary catheter, comprising: a soft first part formed in a cylindrical shape that can be fitted onto the shaft and can be placed at the connection part between the shaft and the base part; and a hard second part that can be fixed to the base by integrally sandwiching the boundary part between the first part and the base part so that a part of the first part is exposed as a free part on the first end side of the shaft.

15. 15. The connecting part for a urinary catheter according to claim 14, wherein the length of the free portion of the first part is 1 cm or more and 5 cm or less when the first part is sandwiched between the second part.

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