Drainage catheter connector
The drainage catheter connector addresses leakage and bacterial entry issues by using a multi-purpose port with a constricted passage and aligned channels to maintain a sealed state during instrument insertion, enhancing aspiration and drainage efficiency.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- KATERA
- Filing Date
- 2024-09-26
- Publication Date
- 2026-05-29
AI Technical Summary
Existing drainage catheters face challenges in maintaining a closed system during insertion of instruments like stylets or guidewires, and pressurized injection or aspiration through conventional catheter connectors leads to potential leakage due to deformation of the slit-type self-sealing valve.
A drainage catheter connector with a multi-purpose port featuring a slit-type self-sealing valve and a constricted passage that accommodates instruments while maintaining a sealed state, reducing leakage by positioning the male Luer taper within a constricted passage smaller than the main passage, aligning the main and port channels in a straight line, and using tapered structures to guide instruments centrally.
The connector allows for instrument insertion while preserving a sealed state, reducing leakage and bacterial growth, and facilitating efficient aspiration and drainage with reduced fluid accumulation, thereby preventing infectious diseases.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to a connector for a drainage catheter for connecting a drainage catheter for discharging body fluid out of the body of a human or animal to a drainage tube.
[0002] Conventionally, a drainage catheter (drainage catheter) for guiding and discharging body fluids (hereinafter referred to as body fluids) in the body, such as blood, cell exudate, digestive fluid, and urine of patients who have difficulty discharging themselves, which have accumulated in the patient's body due to surgery or the like, may be used for patients. Such a drainage catheter is generally connected to a drainage tube connected to a drainage bag via a catheter connector, and the body fluid is discharged into the drainage bag.
[0003] The catheter connector may also be provided with a sampling port for collecting the discharged body fluid with a syringe. The sampling port is provided on the side of the catheter connector, and in order to prevent contamination in the indwelling drainage catheter, a slit-type self-sealing valve that can be sealed in a state where the luer taper part of the syringe is inserted is generally attached to the opening of the sampling port. When collecting the discharged body fluid, a syringe is inserted through such a sampling port to collect the liquid discharged from the drainage catheter to the drainage bag. The slit-type self-sealing valve is provided with a slit penetrating in the thickness direction in the elastic valve body, and the slit forms an insertion hole. The slit is usually closed, but when an instrument such as a luer taper part is inserted, it opens, and at the same time as the opened slit forms an insertion hole, the elastic valve body adheres to the outer peripheral surface of the instrument to seal between the elastic valve body and the instrument. Thereby, it is possible to prevent outside air from entering the inside of the catheter connector and to prevent liquid leakage from the inside of the catheter connector to the outside.
[0004] Drainage catheters are generally made from soft materials such as silicone rubber, and small-diameter drainage catheters are difficult to insert into the body's lumen. Therefore, they are often used with a stylet inserted inside during insertion. For this reason, small-diameter drainage catheters are generally packaged sterile with the stylet already inserted. However, after inserting and leaving the drainage catheter in the body, it is necessary to remove the stylet from the catheter and connect the drainage tube extending from the drainage bag to the catheter. During this connection, bacteria may enter the drainage catheter and cause infection. In particular, urinary catheters, a type of drainage catheter, are often left in the patient's body for short to long periods, and if bacteria enter the urinary catheter, it can cause infection, so infection control is important. Therefore, in order to suppress the entry of bacteria into the drainage catheter, it is preferable that the drainage tube extending from the drainage bag and the drainage catheter are connected via a catheter connector, and that the openings other than the tip of the urinary catheter are sealed with a cap or the like (hereinafter referred to as "closed system"), and that the closed system is maintained even during use.
[0005] However, in a set consisting of a closed system comprising a drainage catheter, catheter connector, drainage tube, and drainage bag, in order to use a stylet or guidewire, it is necessary to separate the drainage tube from the catheter connector before inserting the stylet or guidewire into the drainage catheter, making it impossible to maintain the closed system. Another method is to insert the stylet or guidewire into the drainage catheter through the sampling port of the catheter connector, but since the sampling port is located on the side of the connector, it is necessary to bend the stylet or guidewire at approximately a right angle within the catheter connector before guiding it into the drainage catheter. However, since the stylet or guidewire bent within the catheter connector meanders through the tube wall, the frictional resistance is particularly high in drainage catheters made of silicone rubber, making insertion extremely difficult. For this reason, for example, Patent Document 1 proposes a catheter connector in which a first tubular part connected to the drainage catheter and a second tubular part connected to the drainage tube are connected at an obtuse angle, and a sampling port that communicates linearly with the first tubular part is provided at the connection point between the first and second tubular parts. Using such a catheter connector, a stylet or guidewire inserted through the collection port can be guided linearly into the drainage catheter, making it easier to insert instruments such as stylets and guidewires into the drainage catheter. Therefore, it becomes possible to insert instruments into the drainage catheter while maintaining a closed system. [Prior art documents] [Patent Documents]
[0006] [Patent Document 1] Japanese Patent Publication No. 2022-094560 [Overview of the Initiative] [Problems that the invention aims to solve]
[0007] In recent years, improvements in catheter materials have led to improvements in catheter performance, such as increased lumen diameter and strength. Consequently, there is a growing demand for urinary catheters to enable the washing, aspiration, and drainage of highly viscous urine, including infected urine, thrombosed urine, and cloudy urine, as well as the removal of obstructions in the urinary tract. To meet these demands, it is necessary to enable aspiration and drainage via syringe or pressurized fluid injection through the catheter connector.
[0008] However, even when a syringe is inserted into the collection port located on the side of a conventional catheter connector, the pressure exerted during pressurization or aspiration by the syringe does not act solely towards the tip of the urinary catheter, making it difficult to address the issue. Furthermore, with the catheter connector disclosed in Patent Document 1, the first tubular portion of the catheter connector connected to the drainage catheter is aligned in a straight line with the collection port, making it possible to insert a guidewire through the collection port to remove blockages in the urinary catheter, or to insert a syringe into the collection port to perform aspiration, drainage, or pressurized injection. However, during aspiration, drainage, or pressurized injection through the collection port, reflective pressure acts on the slit-type self-sealing valve attached to the collection port, deforming the elastic valve body of the slit-type self-sealing valve. This can create a gap between the elastic valve body of the slit-type self-sealing valve and the outer surface of the Luer taper portion of the syringe, potentially causing leakage from the slit-type self-sealing valve. Similar problems exist with other drainage catheters as well.
[0009] Therefore, the object of the present invention is to resolve the problems of the prior art and to provide a catheter connector that connects a drainage tube extending from a drainage bag to a drainage catheter, wherein a self-sealing valve that allows insertion of an instrument while maintaining a closed system suppresses leakage that may occur during pressurized injection or aspiration discharge using a syringe. [Means for solving the problem]
[0010] In view of the above object, the present invention is a connector for a drainage catheter for connecting a drainage catheter for draining body fluid out of the body and a drainage tube, comprising: a catheter connection end portion; a port connection end portion; a main pipe having a main flow path linearly extending along the axis of the main flow path between the catheter connection end portion and the port connection end portion; a drainage pipe connected to a side portion of the port connection end portion and having a drainage pipe flow path communicating with the main flow path; and a multi-purpose port having a port flow path linearly extending along the axis of the port flow path between a main pipe connection end portion connected to the port connection end portion and a port end portion on the opposite side of the main pipe connection end portion and communicating with the main flow path. The port flow path includes a valve accommodation portion provided at an end portion on the side of the port end portion and a constriction structure portion provided adjacent to the valve accommodation portion. A slit-type self-sealing valve that can insert an instrument and maintain a sealed state even when the instrument is inserted is accommodated in the valve accommodation portion. The constriction structure portion has a constricted passage having a diameter smaller than the diameters of the main flow path, the drainage pipe flow path, and the valve accommodation portion, and a distance D1 from the opening of the port end portion to the end portion on the side of the port end portion of the constriction structure portion satisfies 0 < D1 < 7.5 mm and the distance from the opening of the port end to the end on the side of the main pipe connection end of the narrow structure part is greater than 7.5 mm To provide a connector for a drainage catheter in which the constriction structure portion is provided at a position
[0011] In the above-described drainage catheter connector, a drainage tube is connected to the side of the port connection end of the main tube, and the main channel of the main tube and the drainage tube channel of the drainage tube are in communication. Therefore, by connecting the drainage catheter to the catheter connection end of the main tube and connecting the drainage tube extending from the drainage bag to the drainage tube, drainage can be sent from the drainage catheter to the drainage tube via the main channel of the main tube and the drainage tube channel, and the drainage can be stored in the drainage bag. In addition, a multipurpose port having a port channel that communicates with the main channel is connected to the port connection end of the main tube, and a slit-type self-sealing valve is housed in the valve housing of the port channel provided at the end furthest from the main tube. Therefore, by inserting an instrument into the slit-type self-sealing valve, it is possible to access the lumen of the drainage catheter via the port channel and the main channel while maintaining a sealed state even when the instrument is inserted. Furthermore, the port passage of the multipurpose port is provided with a constricted structure having a narrowed passage with a diameter smaller than the diameter of the main passage, drainage pipe passage, and valve housing. The constricted structure is positioned so that when the male Luer taper portion of a syringe or Luer adapter, which has a Luer taper conforming to ISO standards formed on its outer surface, is inserted all the way into the slit-type self-sealing valve, the tip of the male Luer taper portion is positioned within the constricted passage. Since the constricted passage of the constricted structure has a smaller diameter than the main passage, when a syringe is inserted into the slit-type self-sealing valve and liquid is injected under pressure into the drainage catheter connector, a small force is required to generate a high pressure within the constricted passage, and the same pressure can be applied to the main passage according to Pascal's principle. In other words, when applying the same pressure to the main passage, a smaller force is required on the syringe compared to when liquid is injected under pressure from a syringe into a passage with the same diameter as the main passage. In addition, since the constricted passage has a smaller diameter than the valve housing, when the tip of the male Luer tapered portion is positioned within the constricted passage, the gap between the outer surface of the male Luer tapered portion and the inner surface of the constricted passage is smaller compared to when the tip of the male Luer tapered portion is positioned within the valve housing. As a result, backflow of the fluid injected from the tip of the male Luer tapered portion is less likely to occur, and the pressure acting on the slit-type self-sealing valve is reduced.Furthermore, since the tip of the male Luer taper can be positioned within a narrow passage with a diameter smaller than the diameter of the valve housing, pressure reflection that can occur at the stepped portion when liquid is injected under pressure with the tip of the male Luer taper positioned inside the valve housing is less likely to occur, and the pressure acting on the slit-type self-sealing valve is reduced. As a result, deformation of the slit-type self-sealing valve is suppressed, and leakage is less likely to occur. This effect is also observed when aspiration is performed with a syringe. In addition, since the narrow passage has a smaller diameter than the main flow path, the flow path volume within the multi-purpose port can be reduced compared to the case where the narrow passage has the same diameter as the main flow path, thereby reducing the amount of drained fluid that accumulates.
[0012] In the above-described drainage catheter connector, it is preferable that the narrowed passage has a diameter that is 20% or more smaller than the diameter of the main channel and the drainage tube channel.
[0014] Furthermore, it is preferable that the main channel axis and the port channel axis are aligned and extend in a straight line.
[0015] In one embodiment, the constricted structure may include a tapered portion at the end on the slit-type self-sealing valve side, with the diameter increasing toward that end, and may also include a tapered portion at the end on the main pipe side, with the diameter increasing toward that end. Alternatively, the constricted structure may include tapered portions at both ends, the slit-type self-sealing valve side and the main pipe side, with the diameter increasing toward each end.
[0016] In the above drainage catheter connector, the diameter of the narrowest part in the narrowed passage B but, satisfies 1.2 mm < B < 4.38 mm This is preferable. For example, the diameter of the narrowest part in the constricted passage. B However, it can be set to be between 1.9 mm and 4.3 mm. Also, the diameter of the narrowest part in the narrowed passage. B but, satisfies 3.92 mm < B < 4.38 mm It is also acceptable to do so. In this case, the distance D2 from the opening of the port end to the end on the port end side of the narrowest part in the narrow passage satisfies 0 < D2 < 7.5 mm Preferably 。 [Effects of the Invention]
[0017] The drainage catheter connector of the present invention allows for the connection of a drainage tube extending from a drainage bag to a drainage catheter. Furthermore, by inserting an instrument into the slit-type self-sealing valve of the multipurpose port, it is possible to access the lumen of the drainage catheter via the port channel and main channel while maintaining a sealed state even during instrument insertion. In addition, the constricted structure included in the port channel of the multipurpose port suppresses deformation of the slit-type self-sealing valve when the male Luer taper portion of a syringe is inserted into the slit-type self-sealing valve for pressurized injection or aspiration discharge, thereby reducing leakage. It also reduces the volume of the channel within the multipurpose port, thereby reducing the amount of drainage fluid that remains. As a result, bacterial growth can be suppressed, and the occurrence of infectious diseases can be prevented. [Brief explanation of the drawing]
[0018]
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Embodiments for Carrying Out the Invention
[0019] Hereinafter, embodiments of a connector for a drainage catheter according to the present invention will be described with reference to the drawings. In the accompanying drawings, the same or similar components throughout the present specification will be denoted by the same reference numerals.
[0020] The connector for a drainage catheter according to the present invention is used to connect a drainage catheter for draining body fluid out of the body when indwelling in a patient's body and a tube such as a drainage tube connected to a drainage bag. In this specification, "patient" includes both a person and an animal who are subjects of treatment. Further, in the following description, the angle formed by an axis and an axis means the angle on the side where the angle formed by the tubes extending along each axis is 180° or less.
[0021] First, the overall configuration of the drainage catheter connector according to the present invention will be described with reference to Figures 1 and 2. The drainage catheter connector 11 of the illustrated embodiment is used to connect a urinary catheter, which is a type of drainage catheter 13 that is placed in the patient's urethra to drain urine from the bladder to the outside of the body, and a urinary tube, which is a type of drainage tube 15 that extends from a urination bag (not shown) as a drainage tube 15, and is capable of handling the drainage of viscous urine while maintaining a closed circuit.
[0022] The drainage catheter connector 11 comprises a main tube 17, a drainage pipe 19, and a multi-purpose port 21.
[0023] The main tube 17 has a catheter connection end 17a for connecting the drainage catheter 13, a port connection end 17b for connecting to the multipurpose port 21, and a main tube flow path 25 extending linearly inward between the catheter connection end 17a and the port connection end 17b, along the main tube flow path axis 23, with the main tube flow path axis 23 being the central axis. In the illustrated embodiment, the drainage catheter 13 is connected to the main tube 17 (specifically, its catheter connection end 17a) of the drainage catheter connector 11 by extrapolating the end of the drainage catheter 13 onto the catheter connection end 17a (i.e., by inserting the catheter connection end 17a into the end of the drainage catheter 13). The catheter connection end 17a is formed so that its entire circumference tapers towards the tip in order to facilitate extrapolation of the end of the drainage catheter 13. Furthermore, the outer surface of the catheter connection end 17a is provided with an engagement portion 27, which has multiple circumferential protrusions with a triangular cross-section formed at intervals in the direction of the main tube flow path axis 23. As a result, after the end of the drainage catheter 13 is inserted onto the catheter connection end 17a, it can be secured to the drainage catheter connector 11 by applying pressure to the engagement portion 27 from the outside with an appropriate fastening device such as a fastening band to prevent it from coming loose.
[0024] The drain pipe 19 has a main pipe side end 19a connected to the port connection end 17b of the main pipe 17, an external connection end 19b on the opposite side of the main pipe side end 19a, and a drain pipe flow path 31 extending inward between the main pipe side end 19b and the external connection end 19b along the drain pipe flow path axis 29, with the drain pipe flow path axis 29 being the central axis. The drain pipe flow path 31 is in communication with the main pipe flow path 25, and the main pipe flow path 25 and the drain pipe flow path 31 form a liquid discharge flow path that discharges liquid from the drain catheter 13 to the drain tube 15 connected to the drain bag. Preferably, the drainage tube 19 is connected to the side of the port connection end 17b such that, at least at the connection point between the main tube 17 and the drainage tube 19, the angle θ that the main tube flow path axis 23 and the drainage tube flow path axis 29 make toward the catheter connection end 13a is obtuse, so that bodily fluids such as urine discharged from the drainage catheter 13 can easily flow into the drainage tube 19. Here, "connected to the side of the port connection end 17b" means that the drainage tube 19 is not connected to the port connection end 17b of the main tube 17 in such a way that the main tube flow path axis 23 and the drainage tube flow path axis 29 are aligned in a straight line, that is, a connection state other than the state in which the drainage tube 19 is connected to the port connection end 17b of the main tube 17 in such a way that the main tube flow path axis 23 and the drainage tube flow path axis 29 are aligned in a straight line, and also includes a configuration in which the main tube 17 is connected to the side of the drainage tube 19 in such a way that the main tube 17 and the drainage tube 19 form an obtuse angle. Furthermore, in the illustrated embodiment, the drain pipe 19 is a straight pipe shape extending in a straight line, but it may also be curved, bent to form multiple corners, or to include a curved portion and a portion bent at a corner.
[0025] The external connection end 19b of the drain pipe 19 is provided with a socket portion having a larger diameter than other parts over a predetermined length from the end opening in the direction of the drain pipe flow path axis 29, and the drain pipe flow path 31 is also formed so that the area corresponding to the socket portion has a larger diameter than other parts. The drain tube 15 is fitted with a plug made of a relatively hard material at its end, and can be liquid-tightly fixed to the drain catheter connector 11 by inserting this plug into the socket portion of the external connection end 19b of the drain pipe 19. For example, the plug of the drain tube 15 may be connected to the socket portion by screwing it in.
[0026] The multipurpose port 21 has a main pipe connection end 21a connected to the port connection end 17b of the main pipe 17, a port end 21b on the opposite side of the main pipe connection end 21a, and a port flow path 35 extending linearly inward between the main pipe connection end 21a and the port end 21b, along the port flow path axis 33, with the port flow path axis 33 being the central axis. The port flow path 35 is in communication with the main pipe flow path 25, and liquids and equipment can be sent and received between the main pipe flow path 25 and the port flow path 35. Here, "connected to the port connection end 17b of the main pipe 17" includes the multipurpose port 21 being connected to the port connection end 17b of the main pipe 17 via the connection between the main pipe 17 and the drain pipe 19. In the illustrated embodiment, the port flow path axis 33 extends so as to be aligned in a straight line with the main pipe flow path axis 23. As the port channel axis 33 is aligned in a straight line with the main channel axis 23, it is possible to efficiently pressurize and aspirate liquid into the main channel 25 through the port channel 35. Furthermore, when inserting an instrument into the main channel 25 through the port channel 35, it is suppressed that the instrument comes into contact with the inner circumferential surface of the port channel 25 and the main channel 25, thereby reducing resistance to movement and facilitating instrument insertion. However, the port channel axis 33 may be positioned at an angle of 135° to 180° relative to the main channel axis 23, preferably towards the main 17, and more preferably at an angle of 150° to 180° relative to the main 17. If the port channel axis 33 extends within this angle range relative to the main channel axis 23, it is possible to reduce the resistance of the instrument against the inner circumferential surface of the port channel 25 and the main channel 25 when inserting the instrument into the main channel 25 through the port channel 35.
[0027] The port passage 35 includes a valve housing 35a provided at the port end 21b side (i.e., the end furthest from the main pipe 17) and a constricted structure 35b provided adjacent to the valve housing 35a. A slit-type self-sealing valve 37 is housed and installed in the valve housing 35a, and the portion of the valve housing 35a not occupied by the slit-type self-sealing valve 37 forms a syringe chamber. However, the slit-type self-sealing valve 37 may occupy the entire valve housing 35a, and a syringe chamber may not be provided. The slit-type self-sealing valve 37 has a disc-shaped elastic valve body 37a with one or more intersecting slits 37b penetrating in the thickness direction, and the slits 37b constitute an insertion hole, allowing instruments to be inserted through the slits 37b and maintaining a sealed state even when instruments are inserted. Examples of instruments that can be inserted into the slit-type self-sealing valve 37 include syringes (specifically their male Luer taper portion), guidewires, stylets, etc. The shape of the slit 37b in a cross-section perpendicular to the port flow path axis 33 can be, for example, a straight line or a cross shape. In this embodiment, the slit 37b is a straight line that passes through the center of the elastic valve body 37a and extends radially without reaching the outer edge. Alternatively, slits 37b extending from both ends in the thickness direction of the elastic valve body 37a may intersect at the center in the thickness direction to form an insertion hole. The slit 37b is normally closed, but opens when, for example, the male Luer tapered portion is inserted, and the opened slit 37b adheres tightly to the outer surface of the male Luer tapered portion, sealing the space between the elastic valve body 37a and the male Luer tapered portion. This prevents outside air from entering the port flow path 35 and prevents liquid leakage from the inside of the port flow path 35 to the outside.
[0028] As described above, by attaching a slit-type self-sealing valve 37 to the end of the port channel 35 of the multipurpose port 21, if the drainage catheter 13 and the drainage tube extending from the drainage bag are connected via the drainage catheter connector 11 and then sterile-packaged, the sealed state can be maintained even after opening, except for the tip of the drainage catheter 13. While maintaining the sealed state, instruments such as syringes, guidewires, and stylets can be inserted into the drainage catheter connector 11 via the multipurpose port 21. This makes it possible to drain, aspirate, and wash the drainage catheter 13 by means of the drainage catheter connector 11, including the removal of thrombi and other clumps, as well as viscous urine.
[0029] A constricted passage, which forms part of the port channel 35, extends through the constricted structure 35b. The constricted passage, i.e., the port channel 35 in the constricted structure 35b, has a smaller diameter than the main channel 25, the drainage pipe channel 31, and the valve housing 21b, and is preferably 20% or more smaller than the diameter of the main channel 25. The constricted structure 35b is formed by an annular protrusion that rises from the inner circumferential surface of the port channel 35. In the illustrated embodiment, the annular protrusion forming the constricted structure 35b has a triangular (mountain-shaped) cross-section along the port channel axis 33, but it may have other shapes as long as the diameter of the port channel 35 can be made smaller than the main channel 25, etc. For example, the annular protrusion forming the constricted structure 35b may have a rectangular cross-section along the port channel axis 33, as shown in Figure 3(a), or it may have an elliptical shape, as shown in Figure 3(b). Furthermore, the annular protrusion forming the constricted structure 35b may have, in a cross-section along the port flow path axis 33, a tapered portion that widens from the main pipe connection end 21a side toward the port end 21b side, as shown in Figure 3(c); a tapered portion that widens from the port end 21b side toward the main pipe connection end 21a side, as shown in Figure 3(d); or, as shown in Figure 3(e), a trapezoidal shape with tapered portions that widen toward the respective ends at both the main pipe connection end 21a side and the port end 21b side.
[0030] As shown in Figures 3(b), 3(c), and 3(e), if the annular protrusion forming the stenotic structure 35b has a tapered portion at the port end 21b side that widens from the main pipe connection end 21a side towards the port end 21b side, then when inserting a guidewire or stylet through the slit-type self-sealing valve 37, the tip of the guidewire or stylet is guided closer to the central axis of the port flow path 35 by the tapered portion. This suppresses contact with the inner surface of the main pipe 17 or the drainage catheter connected thereto, making it easier to insert the guidewire or stylet. Similarly, as shown in Figures 3(b), 3(d), and 3(e), if the annular protrusion forming the stenotic structure 35b has a tapered portion at the end on the main pipe connection side 21a that widens from the port end 21b toward the main pipe connection side 21a, then when inserting a guidewire or stylet from the tip of the drainage catheter 13 connected to the main pipe 17, the tip of the guidewire or stylet is guided toward the central axis of the port flow path 35 by the tapered portion, making it easier to insert the guidewire or stylet into the slit 37b of the slit-type self-sealing valve main pipe 37.
[0031] Next, the detailed configuration of the constricted structure 35b will be described with reference to Figure 4. Figure 4 is an enlarged cross-sectional view showing the constricted structure 35b in the form shown in Figure 3(e) for the convenience of describing the detailed configuration of the constricted structure 35b. Hereafter, the constricted structure 35b will be described as being in the form shown in Figure 4.
[0032] As described above, the constricted structure 35b shown in Figure 4 has tapered sections 39 and 41 that widen toward each end on both the main pipe connection end 21a side and the port end 21b side, with the smallest diameter straight pipe section, the minimum diameter section 43, provided between them. Here, let A be the diameter of the portion of the port flow path 35 closer to the main pipe connection end 21a than the constricted structure 35b, B be the diameter of the minimum diameter section 43 of the constricted passage of the constricted structure 35b, and C be the diameter of the portion of the constricted structure 35b closer to the port end 21b. Let D1 be the distance from the opening of the port end 21b to the constricted structure 35b (specifically, the end of the constricted structure 35b closer to the port end 21b), and let D2 be the distance from the port end 21b to the minimum diameter section 43 (specifically, the end of the minimum diameter section 43 closer to the port end 21b). Furthermore, S1 is the outer diameter at the base of the male Luer tapered portion 45a of the syringe 45 inserted into the slit-type self-sealing valve 37, S2 is the outer diameter at the tip of the male Luer tapered portion 45a, S3 is the inner diameter at the tip of the male Luer tapered portion 45a, and L is the length from the base to the tip of the male Luer tapered portion 45a. Note that the male Luer tapered portion 45a of the syringe 45 refers to the tip portion of the syringe 45 or a Luer adapter (not shown) attached to the tip of the syringe 45, in which a Luer taper conforming to the ISO 80369 standard is formed on the outer surface.
[0033] In the illustrated embodiment, the diameter A of the port channel 35 closer to the main pipe connection end 21a than the constricted structure 35b, and the diameter C of the port channel 35 closer to the port end 21b than the constricted structure 35b, are equal to the inner diameter of the main pipe 17, i.e., the diameter of the main channel 25. However, diameters A and C do not need to be equal to the diameter of the main channel 25; any diameter can be selected as long as it is larger than the diameter B of the minimum diameter portion 43 of the constricted passage.
[0034] By providing a constricted structure 35b in the port channel 35, the volume of the port channel 35 is reduced, thereby decreasing the amount of drainage fluid that remains in the port channel 35. As a result, an inhibitory effect is obtained that suppresses bacterial growth and reduces the possibility that the stagnant drainage fluid may cause infectious diseases.
[0035] The constricted structure 35b is positioned so that when the male Luer tapered portion 45a of the syringe 45 or the Luer adapter attached to the syringe 45 is inserted all the way into the slit-type self-sealing valve 37, the tip of the male Luer tapered portion 45a is positioned within the constricted structure 35b. By positioning the constricted structure 35b in this way, the tip of the male Luer tapered portion 45a of the syringe 45 or the Luer adapter attached to the tip of the syringe 45 is positioned within the constricted structure 35b, which has a relatively small cross-section within the port flow path 35.
[0036] Here, with reference to Figure 5, the positional relationship between the constricted structure 35b and the tip of the male Luer tapered section 45a will be explained in detail. The form of the constricted structure 35b, in which the cross-section of the annular protrusion is triangular as shown in Figures 1 and 2, can be considered a special case in the form of the constricted structure 35b shown in Figures 3(e) and 4, where the width of the minimum diameter section 43 (i.e., the length in the direction of the port flow path axis 33) is 0 and the smallest diameter parts of the two tapered sections 39 and 41 overlap. The form of the constricted structure 35b shown in Figure 3(a) can be considered as the form of the constricted structure 35b shown in Figures 3(e) and 4, in which the two tapered sections 39 and 41 are omitted. Furthermore, the form of the constricted structure 35b shown in Figure 3(b) can be considered as the constricted structure 35b of the embodiment shown in Figures 1 and 2, in which the tapered sections 39 and 41 are composed of elliptical curves. In other words, the constricted structure 35b of the embodiment shown in Figures 1 and 2, and the constricted structure 35b of the form shown in Figures 3(a) to 3(d) can be considered special cases of the constricted structure 35b of the form shown in Figure 3(e). Therefore, in the following, the positional relationship between the constricted structure 35b and the tip of the male Luer taper portion 45a will be explained using the constricted structure 35b of the form shown in Figure 3(e) as an example.
[0037] As described above, the constricted structure 35b is provided in a position where the tip of the male Luer tapered portion 45a is positioned within the constricted passage of the constricted structure 35b when the male Luer tapered portion 45a of the syringe 45 or the Luer adapter attached to the syringe 45 is inserted into the slit-type self-sealing valve 37 to its base. The tip of the male Luer tapered portion 45a inserted into the slit-type self-sealing valve 37 may be positioned within the tapered portion 41 located on the port end 21b side in the constricted passage, as shown in Figure 5(a), or it may be positioned within the minimum diameter portion 43 of the constricted passage or beyond the minimum diameter portion 43, as shown in Figure 5(b). When the tip of the male Luer tapered portion 45a is positioned within the tapered portion 41 of the constricted passage, as shown in Figure 5(a), it is preferable that the tip of the male Luer tapered portion 45a is in contact with the inner circumferential surface of the tapered portion 41 of the constricted passage, as shown in Figure 5(c). Furthermore, as shown in Figure 5(b), if the tip of the male Luer tapered portion 45a is positioned within or beyond the minimum diameter portion 43 of the constricted passage, it is preferable that the male Luer tapered portion 45a inserted into the slit-type self-sealing valve 37 has a portion of its outer circumferential surface in contact with the inner circumferential surface of the minimum diameter portion 43 of the constricted passage (or, if the cross-section of the raised portion constituting the constricted structure portion 35b is mountain-shaped, the apex thereof), as shown in Figure 5(d).
[0038] When the tip of the male Luer taper portion 45a of the syringe 45 is positioned within the narrowed passage of the narrowed structure portion 35b, the liquid in the syringe 45 is injected into the port channel 35, which has a relatively small cross-section. This allows for the generation of higher pressure with less force compared to when the liquid in the syringe 45 is injected into the port channel 35, which has a larger cross-section than the narrowed structure portion 35b. According to Pascal's principle, a pressure equal to the pressure within the narrowed passage of the narrowed structure portion 35b acts on the main channel 25 of the main tube 17 of the drainage catheter connector 11, which communicates with the narrowed passage (i.e., the port channel 35), and the lumen of the drainage catheter 13 connected thereto. This is also true when aspirating with the syringe 45. Therefore, by using the syringe 45 inserted into the slit-type self-sealing valve 37, a high pressure or suction force can be applied with less force to the main channel 25 of the main tube 17 of the drainage catheter connector 11 and the lumen of the drainage catheter 13 connected thereto, making it easier to pressurize and remove lumps such as thrombi that are lodged in the main channel 25 of the main tube 17 and the lumen of the drainage catheter 13.
[0039] Furthermore, as shown in Figure 5(a), if the tip of the male Luer tapered portion 45a of the syringe 45 is positioned within at least the tapered portion 41 of the constricted passage of the constricted structure portion 35b, the gap between the outer surface of the tip of the male Luer tapered portion 45a and the inner surface of the port flow path 35 becomes narrower compared to the case where the tip of the male Luer tapered portion 45a of the syringe 45 is positioned in a part of the port flow path 35 other than the constricted structure portion 45a, as shown in Figure 6. Therefore, as shown in Figure 7, the flow of liquid discharged from the syringe 45 back towards the port end 21b (i.e., backflow) is reduced, and the occurrence of backflow load can be suppressed. As a result, the pressure acting on the slit-type self-sealing valve 37 due to backflow load is reduced, and the occurrence of leakage due to deformation of the slit-type self-sealing valve 37 can be suppressed. When the inner diameter B of the smallest diameter portion 45 of the narrowed passage of the narrowed structure portion 35b is larger than the inner diameter S3 of the tip of the male Luer tapered portion 45a, the liquid sprayed straight from the tip of the male Luer tapered portion 45a proceeds into the smallest diameter portion 45 and is less likely to collide with the inner circumferential surface or stepped portion of the tapered portion 41, thereby enhancing the above-mentioned effect.
[0040] Furthermore, as shown in Figure 5(b), when the tip of the male Luer tapered portion 45a is positioned within the minimum diameter portion 45 of the constricted passage, the liquid in the syringe 45 does not collide with the inner circumferential surface of the tapered portion 41 or with the stepped portion in the case of the form shown in Figure 3(a) when the liquid in the syringe 45 is ejected straight from the tip of the male Luer tapered portion 45a. As a result, as shown in Figure 8, there is no return flow to the port end 21b side due to collision, and the liquid tends to move only forward. Therefore, force can be efficiently applied to the mass in the drainage catheter 13 or main tube 17, making it easier to clean, remove, and discharge the mass. When the inner diameter B of the minimum diameter portion 45 of the constricted passage of the constricted structure 35b is larger than the inner diameter S3 of the tip of the male Luer tapered portion 45a, the liquid ejected straight from the tip of the male Luer tapered portion 45a moves into the minimum diameter portion 45 and is less likely to collide with the inner circumferential surface of the tapered portion 41 or with the stepped portion, thus enhancing the above-mentioned effect. In particular, as shown in Figure 5(d), when the tip of the male Luer tapered portion 45a is positioned within the minimum diameter portion 45 of the narrowed passage and a part of the outer circumferential surface of the male Luer tapered portion 45a is in contact with the inner circumferential surface of the minimum diameter portion 43, the gap between the inner circumferential surface of the port passage 35 and the outer circumferential surface of the male Luer tapered portion 45a is eliminated, and even if pressure or suction is applied with the syringe 45, no force from the syringe 45 acts on the valve housing portion 35a. Therefore, the effect of further suppressing the force applied to the slit-type self-sealing valve 37 due to backflow load and further suppressing leakage due to deformation of the slit-type self-sealing valve 37 can be further improved.
[0041] As shown in Figure 5(c), even when the tip of the male Luer tapered portion 45a is positioned within the tapered portion 41 of the narrowed passage and in contact with the inner circumferential surface of the male Luer tapered portion 45a, the gap between the inner circumferential surface of the port passage 35 and the outer circumferential surface of the male Luer tapered portion 45a is eliminated. Therefore, as in the case shown in Figure 5(d), the effect of suppressing leakage due to deformation of the slit-type self-sealing valve 37 can be further improved. Also, as shown in Figure 5(a), when the tip of the male Luer tapered portion 45a is positioned within the tapered portion 41, when liquid from the syringe 45 is ejected from the tip of the male Luer tapered portion 45a, some of the ejected liquid may collide with the inner circumferential surface of the tapered portion 41, potentially causing a backflow. However, if the inner diameter of the smallest diameter portion 43 of the narrowed passage of the narrowed structure portion 35b is larger than the inner diameter S3 of the tip of the male Luer tapered portion 45a, then, assuming that the liquid in the syringe 45 is ejected straight from the tip of the male Luer tapered portion 45a, as shown in Figure 10, the liquid will proceed only within the smallest diameter portion 43, and collision with the inner circumferential surface of the tapered portion 41 can be suppressed. This similarly suppresses the force acting on the slit-type self-sealing valve 37 due to backflow load, and has the effect of suppressing leakage caused by deformation of the slit-type self-sealing valve 37.
[0042] In addition, as shown in Figure 5(d), when the tip of the male Luer tapered portion 45a is positioned within the minimum diameter portion 45 and a part of the outer surface of the male Luer tapered portion 45a is in contact with the inner surface of the minimum diameter portion 43 of the narrowed passage, the tip of the male Luer tapered portion 45a is locked to the minimum diameter portion 45. This prevents the syringe 45 from tilting relative to the drainage catheter connector 11 during operation of the syringe 45, and also has the effect of suppressing leakage caused by the male Luer tapered portion 45 deforming the elastic valve body 45a of the slit-type self-sealing valve 37. These effects can also be achieved when the tip of the male Luer tapered portion 45a is in contact with the inner surface of the tapered portion 41 of the narrowed passage, as shown in Figure 5(c).
[0043] Thus, it is preferable that the diameter B of the smallest diameter portion 43 of the constricted passage of the constricted structure portion 35b is larger than the inner diameter S3 of the tip of the male Luer tapered portion 45a, so that the liquid sprayed straight from the tip of the male Luer tapered portion 45a can easily pass through the smallest diameter portion 43. Furthermore, it is preferable that the distance D1 from the opening of the port end 21b to the constricted structure portion 35b (specifically, the end of the tapered portion 41 on the port end 21b side) is shorter than the length L from the base to the tip of the male Luer tapered portion 45a, so that when the male Luer tapered portion 45a is inserted to its base into the slit-type self-sealing valve 37 mounted in the valve housing portion 35a, the tip of the male Luer tapered portion 45a can reach at least into the tapered portion 41 of the constricted structure portion 35b.
[0044] Furthermore, it is preferable that the diameter B of the minimum diameter portion 43 of the constricted passage of the constricted structure portion 35b is larger than the outer diameter S2 of the tip of the male Luer tapered portion 45a so that the tip of the male Luer tapered portion 45a can be positioned within the minimum diameter portion 43, and smaller than the outer diameter S3 of the base of the male Luer tapered portion 45a so that the outer circumferential surface of the male Luer tapered portion 45a can contact the inner circumferential surface of the minimum diameter portion 43. In addition, it is preferable that the distance D2 from the opening of the port end 21b to the minimum diameter portion 43 (specifically, the end of the minimum diameter portion 43 on the port end 21b side) is shorter than the length L from the base to the tip of the male Luer tapered portion 45a so that when the male Luer tapered portion 45a is inserted to the base into the slit-type self-sealing valve 37 mounted in the valve housing portion 35a, at least a part of the male Luer tapered portion 45a can be positioned within the minimum diameter portion 43 of the constricted passage of the constricted structure portion 35b.
[0045] From the above, in the narrow structure portion 35b, the diameter B of the minimum diameter portion 43 is smaller than the diameter A of the portion closer to the main pipe connection end portion 21a than the narrow structure portion 35b in the port flow path 35 and the diameter C of the portion closer to the port end portion 21b than the narrow structure portion 35b. Also, the diameter B of the minimum diameter portion 43 is preferably larger than the inner diameter S3 at the tip of the male luer taper portion 45a and smaller than the outer diameter S1 at the base of the male luer taper portion S1, and more preferably larger than the outer diameter S2 at the tip of the male luer taper portion 45a and smaller than the outer diameter S1 at the base of the male luer taper portion S1. That is, it is preferable to satisfy S3 < B < S1, and it is preferable to satisfy S2 < B < S1. Regarding the position of the narrow structure portion 35b, it is preferable that the distance D1 from the opening of the port end portion 21 to the end portion on the port end portion 21b side of the taper portion 41 on the port end portion 21b side is smaller than the distance L from the base to the tip of the male luer taper portion 45a, and it is more preferable that the distance D2 from the opening of the port end portion 21 to the end portion on the port end portion 21b side of the minimum diameter portion 43 is smaller than the distance L from the base to the tip of the male luer taper portion 45a. That is, it is preferable to satisfy 0 < D1 < L, and it is more preferable to satisfy 0 < D2 < L.
[0046] In urine collection applications using a urinary catheter or the like, a small-diameter syringe 45 having a male luer taper portion 45a conforming to the ISO80369-7 standard and a luer adapter are often used. In the ISO80369-7 standard, the outer diameter S1 at the base of the male luer taper portion is in the range of 4.375 mm to 4.38 mm, the outer diameter S2 at the tip of the male luer taper portion is 3.92 mm to 3.925 mm, the inner diameter S3 at the tip of the male luer taper portion is 1.2 mm or more, and the length L from the base to the tip of the male luer taper portion is defined as 7.5 mm. Therefore, in the application of connecting a urinary catheter and a urine drainage tube connected to a urine drainage bag, the diameter B of the minimum diameter portion 43 of the narrow structure portion 35b of the drain catheter connector 11 is preferably in the range of 1.9 mm to 4.3 mm. Also, the position of the narrow structure portion 35b of the drain catheter connector 11 preferably satisfies 0 < D1 < 7.5 mm, and more preferably satisfies 0 < D2 < 7.5 mm.
Explanation of reference numerals
[0047] 11. Connector for drainage catheter 13 Drainage catheter 15 Drainage tube 17 Supervisor 17a Catheter connection end 17b Port connection end 19 Drainage pipe 19a Main pipe side end 19b External connection end 21 Multipurpose Ports 21a Main pipe connection end 21b Port end 23 Main channel axis 25 Main channel 29 Drainage pipe flow path axis 31 Drainage pipe flow path 33 Port flow path axis 35 Port Flow Channels 35a Valve housing 35b Stenosis structure 37. Slit-type self-sealing valve 39 Tapered section 41 Tapered section 43 Minimum diameter part 45 syringes 45a Male Luer Taper Section
Claims
1. A drainage catheter connector for connecting a drainage catheter and drainage tube, which are placed inside the body to drain bodily fluids from the body, A main tube having a catheter connection end, a port connection end, and a main channel extending linearly along the axis of the main channel between the catheter connection end and the port connection end, A drain pipe having a drain pipe channel connected to the side of the port connection end and communicating with the main pipe channel, A multipurpose port having a port channel that extends linearly along the port channel axis and communicates with the main channel between a main pipe connection end connected to the port connection end and a port end opposite to the main pipe connection end, A drainage catheter connector comprising: the port flow path including a valve housing provided at the end on the port end side and a constriction structure provided adjacent to the valve housing; a slit-type self-sealing valve that allows an instrument to be inserted and maintains a sealed state even when the instrument is inserted is housed in the valve housing; the constriction structure has a constricted passage having a diameter smaller than the diameter of the main flow path, the drainage tube flow path, and the valve housing; the distance D1 from the opening of the port end to the end of the constriction structure on the port end side satisfies 0 < D1 < 7.5 mm and the constriction structure is provided at a position where the distance from the opening of the port end to the end of the constriction structure on the main connection end side is greater than 7.5 mm.
2. The drainage catheter connector according to claim 1, wherein the narrowed passage has a diameter that is 20% or more smaller than the diameter of the main channel and the drainage tube channel.
3. The drainage catheter connector according to claim 2, wherein the main channel axis and the port channel axis are aligned and extend in a straight line.
4. The drainage catheter connector according to claim 3, wherein the constricted structure includes a tapered portion at the end on the slit-type self-sealing valve side, the tapered portion having a diameter that widens toward the end.
5. The drainage catheter connector according to claim 3, wherein the stenotic structure includes a tapered portion at the end on the main tube side, the tapered portion having a diameter that widens toward the end.
6. The drainage catheter connector according to claim 3, wherein the constricted structure includes tapered portions at both ends, the slit-type self-sealing valve side and the main pipe side, with the diameter increasing toward each end.
7. A drainage catheter connector according to any one of claims 1 to 6, wherein the diameter B of the narrowest part in the narrowed passage satisfies 1.2 mm < B < 4.38 mm.
8. The drainage catheter connector according to claim 7, wherein the diameter B of the narrowest part in the narrowed passage satisfies 3.92 mm < B < 4.38 mm.
9. The drainage catheter connector according to claim 7, wherein the diameter B of the narrowest part in the narrowed passage is 1.9 mm or more and 4.3 mm or less.
10. The drainage catheter connector according to claim 8, wherein the distance D2 from the opening of the port end to the end of the narrowest part of the constricted passage on the port end side satisfies 0 < D2 < 7.5 mm.