Drainage catheter

Abstract

To provide a drain catheter whose shape can be held stably, and which can secure a sufficient flow passage area.SOLUTION: A flat-type drain catheter 100 includes a fluid collection part 110, a transfer part 140, a drainage part 160, and a main flow passage 101. The fluid collection part 110 includes a main lumen 101A forming the main flow passage 101 and two partition wall parts 105 extending in an axial direction, which are erected toward the outer side at positions opposed to each other in an outer wall 102A of the main lumen 101A in a cross-section in a radial direction, each of the two partition wall parts 105 having a first groove part 111 extending in the axial direction.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present disclosure relates to a drain catheter.

Background Art

[0002] In order to drain blood, pus, exudate, etc. (hereinafter also referred to as "exudate, etc.") generated in the body, such as in the thoracic cavity, abdominal cavity, wound site, etc. after surgery, a tube called a drain catheter is used. A general drain catheter has a liquid collection part that is placed in the body and collects exudate, etc., a liquid discharge part that is connected to a storage bag, a suction device, etc., and a transition part that connects the liquid collection part and the liquid discharge part.

[0003] Exudate, etc. generated in the body contains various components and is likely to coagulate. In many cases, it also contains solid or semi-solid substances such as blood clots and body tissue fragments. Therefore, a drain catheter that collects exudate, etc. and guides it outside the body is likely to become blocked or closed. In order to suppress the occurrence of clogging and make it difficult to close the liquid collection part, the liquid collection part is divided into a plurality of parts extending in the long side direction, and slits or the like extending in the long side direction are provided in each part (for example, refer to Patent Document 1).

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] By the way, in order to increase the flow path area in the liquid collection part, it is conceivable to reduce the wall thickness of the liquid collection part. However, when the wall thickness of the liquid collection part is reduced, there is a problem that it becomes difficult to stably maintain the shape of the liquid collection part during the molding of the liquid collection part or during the use of the drain catheter.

[0006] Therefore, the objective of this disclosure is to provide a drain catheter that can stably maintain its shape while ensuring a sufficient flow channel area. [Means for solving the problem]

[0007] To solve the above problems, one embodiment of a drain catheter disclosed herein is a flat-type drain catheter comprising: a fluid collection section; a transition section provided proximal to the fluid collection section; a drainage section provided proximal to the transition section; and a main flow path extending axially along the entire length of the fluid collection section, the transition section, and the drainage section, wherein the fluid collection section has a main lumen forming the main flow path and two partition walls erected outward at mutually opposing positions on the outer wall of the main lumen in a radial cross-section and extending axially, and each of the two partition walls includes a first groove extending axially.

[0008] In this configuration, two partition walls, each containing a first groove, are provided on the outer wall of the main lumen at positions opposite to each other. That is, in the liquid collection section, the main lumen is positioned between the two first grooves. As a result, in the radial cross-section of the liquid collection section, the main lumen is positioned in the center along the longer side, so even if the wall thickness of the liquid collection section is reduced, the shape of the liquid collection section can be stably maintained. Furthermore, by reducing the wall thickness of the liquid collection section, a sufficient flow area can be secured in the liquid collection section. Moreover, in this configuration, since the first grooves are included in the partition walls, they are less susceptible to the effects of deformation of the main lumen. That is, even if, for example, an external force acts on the outer wall forming the main lumen, crushing the main lumen from both sides along the shorter side, the effect of deformation on the main lumen can be suppressed from extending to the first grooves, and the shape of the first grooves can be maintained to some extent. Thus, even if the main lumen is crushed, for example, the flow path of the first grooves can be secured.

[0009] The partition wall portion preferably has, in its radial cross-section, a first partition wall connected to the outer wall of the main lumen, two second partition walls extending further outward from the tip of the first partition wall, and two third partition walls extending further outward from the respective tips of the two second partition walls, and the first groove portion preferably consists of a space enclosed by the two second partition walls and the two third partition walls.

[0010] This configuration ensures a sufficient flow area in the first groove.

[0011] It is preferable that the first partition wall and the two second partition walls are arranged in a Y-shape in the radial cross-section.

[0012] In this configuration, the first septum and the two second septums are arranged in a Y-shape, so that these septums are formed in a balanced manner during the molding of the fluid collection section. Thus, even if the fluid collection section is made thinner, the shape of the first groove can be reliably maintained during the molding of the fluid collection section. Furthermore, because the first septum and the two second septums are arranged in a Y-shape, the septum sections have appropriate flexibility. As a result, when the fluid collection section is placed in a narrow area such as between organs, it can deform to conform to the surrounding shape while maintaining the flow path of the first groove. In this way, effective drainage of exudate and other fluids can be achieved while reducing the burden on the patient.

[0013] The angle between the two second partitions on the sides where the first partition is absent is preferably 60° or more and less than 180°.

[0014] With this configuration, these partitions are formed in a balanced manner during the molding of the liquid collection section. As a result, even if the liquid collection section is made thinner, the shape of the first groove can be reliably maintained. In addition, the partitions can be given appropriate flexibility.

[0015] Preferably, each of the two third partition walls has a curved portion extending toward the other, and a first slit extending in the axial direction is formed at the tip of the curved portion.

[0016] In this configuration, exudate and other fluids are guided into the first groove through the first slit extending in the axial direction. This makes it less likely for blockages to occur in the first groove, and enables effective drainage of exudate and other fluids.

[0017] Preferably, the proximal end of the liquid collection section is formed by the two second partitions and the two third partitions, with the tips of the two third partitions connected to each other, and includes a first lumen connected to the first groove.

[0018] The proximal end of the fluid collection section is connected to the transition section. By providing a first lumen in the proximal end, including the proximal end, the stiffness of the drain catheter can be changed in stages from the fluid collection section to the transition section. This improves the kink resistance at the connection point between the fluid collection section and the transition section.

[0019] Preferably, the partition wall portion has a fourth partition wall in its radial cross-section that is connected to the tip of the second partition wall and extends toward the main lumen, and the liquid collection portion further consists of a space enclosed by the first partition wall, the second partition wall, the fourth partition wall, and the outer wall of the main lumen, and has a second groove portion extending in the axial direction.

[0020] With this configuration, exudate can be aspirated not only in the first groove but also in the second groove around the main lumen, allowing for efficient aspiration of exudate and other fluids around the fluid collection area.

[0021] Preferably, the proximal end of the liquid collection section is formed by the two second partitions and the two third partitions by connecting the tips of the two third partitions to each other, and includes a first lumen connected to the first groove, and the proximal end of the liquid collection section is formed by the first partition, the second partition, the fourth partition and the outer wall of the main lumen by connecting the tip of the fourth partition to the outer wall of the main lumen, and includes a second lumen connected to the second groove.

[0022] According to this configuration, by forming the second lumen on the proximal end side of the second groove portion, the connection to the lumen formed in the transition portion is facilitated.

[0023] It is preferable that the axial length of the second lumen is shorter than the axial length of the first lumen.

[0024] By providing the second lumen, the connection to the lumen of the transition portion can be facilitated. On the other hand, if the axial length of the second lumen, which has a smaller flow path area than the second groove portion, is increased, the risk of blockage in the second lumen increases. According to this configuration, while improving the kink resistance by increasing the axial length of the first lumen, the axial length of the second lumen is minimized, enabling a smooth connection to the lumen of the transition portion.

[0025] The transition portion has a central lumen connected to the main lumen to form the main flow path and a side lumen disposed on the side of the central lumen. It is preferable that the side lumen is connected to the first lumen and the second lumen.

[0026] According to this configuration, the first groove portion and the second groove portion communicate with the side lumen of the transition portion via the first lumen and the second lumen, enabling smooth discharge of exudate and the like.

[0027] It is preferable that the liquid collection portion is made of a resin material containing barium.

[0028] According to this configuration, the visibility of the liquid collection portion indwelling in the body under fluoroscopy can be improved.

[0029] It is preferable that the outer wall forming the main lumen does not form the first groove portion.

[0030] In this configuration, since the outer wall forming the main lumen does not have a first groove, even if an external force acts on the outer wall forming the main lumen and the main lumen deforms, deformation of the first groove can be suppressed. Thus, even if the main lumen collapses, for example, the flow path of the first groove can be maintained.

[0031] One embodiment of a drain catheter disclosed herein is a flat-type drain catheter comprising: a fluid collection section; a transition section provided proximal to the fluid collection section; a drainage section provided proximal to the transition section; and a main flow path extending axially along the entire length of the fluid collection section, the transition section, and the drainage section, wherein the fluid collection section has a main lumen forming the main flow path and a plurality of grooves arranged on the outer circumference of the main lumen and extending axially, and the transition section has a triple-lumen structure including a central lumen connected to the main lumen and forming the main flow path; a first side lumen arranged on one side of the central lumen and communicating with a groove among the plurality of grooves located on one side of the main lumen; and a second side lumen arranged on the other side of the central lumen and communicating with a groove among the plurality of grooves located on the other side of the main lumen.

[0032] With this configuration, the transition section has a triple-lumen structure, which ensures sufficient flow area in each lumen. This ensures sufficient flow rate when using a drain catheter and reduces the risk of flow path obstruction.

[0033] The transition portion has, in its radial cross-section, two first wall portions arranged on both sides in the long-side direction and forming the first and second side lumens, respectively, and four second wall portions arranged on both sides in the short-side direction and forming the first and second side lumens, wherein the thickness of the first wall portions is preferably greater than the thickness of the second wall portions.

[0034] When using a drain catheter, the distal end of the transition section is placed inside the body, while the proximal end is placed outside the body. At this time, the transition section is secured by suturing it to the patient's skin with sutures or the like. By making the thickness of the first wall of the transition section greater than the thickness of the second wall, the kink resistance of the transition section can be improved. This reduces the risk of the transition section collapsing and obstructing the flow path when it is tied with sutures or the like.

[0035] Preferably, the transition portion comprises a main body made of a transparent or translucent resin material and a marker portion provided on the main body and made of a resin material containing barium.

[0036] The transparent or semi-transparent main body allows for visual confirmation of the color, condition, and other characteristics of the exudate guided through the flow path. Furthermore, the inclusion of a marker improves the visibility of the implanted portion under X-ray fluoroscopy.

[0037] Preferably, the marker portion is provided on the outer wall forming the central lumen, extending along the entire length of the transition portion.

[0038] Since the marker portion is provided along the entire length of the transition section, visibility within the body under X-ray fluoroscopy can be improved regardless of the proportion of the transition section that is implanted in the body. Furthermore, since the marker portion is provided on the outer wall forming the central lumen, that is, at the center in the long-side direction of the outer wall forming the transition section, visibility within the body under X-ray fluoroscopy can be further improved. [Effects of the Invention]

[0039] As described above, this disclosure provides a drain catheter that can stably maintain its shape and secure a sufficient flow channel area. [Brief explanation of the drawing]

[0040] [Figure 1] This is an overall diagram showing an example of a drain catheter related to this disclosure. [Figure 2]This is a cross-sectional view along line AA in Figure 1. [Figure 3] This is a cross-sectional view along line BB in Figure 1. [Figure 4] This is a cross-sectional view along the CC line in Figure 1. [Figure 5] This is a cross-sectional view along the DD line in Figure 1. [Figure 6] This is a cross-sectional view along the EE line in Figure 1. [Modes for carrying out the invention]

[0041] Embodiments of the present disclosure will be described in detail below with reference to the drawings. The following description of preferred embodiments is illustrative in nature and is not intended to limit the present disclosure, its applications or uses in any way.

[0042] (Embodiment 1) <Drainage catheter> Figure 1 is an overall view showing an example of a drain catheter 100 according to this disclosure.

[0043] As shown in Figure 1, the drain catheter 100 is a tubular member comprising a fluid collection section 110, a transition section 140 located proximal to the fluid collection section 110, and a drainage section 160 located proximal to the transition section 140. As shown in Figure 1, the end of the drain catheter 100 that is placed inside the body is called the distal end, and the end that is placed outside the body is called the proximal end.

[0044] The drain catheter 100 is a so-called multi-slit type flat drain catheter. That is, the fluid collection section 110 is provided with multiple slits. The radial cross-sections of the fluid collection section 110 and the transition section 140 have elongated shapes such as rectangles, ellipses, or oblongs. For example, as shown in Figure 2, the longitudinal direction and the short direction in the radial cross-section of the fluid collection section 110 and the transition section 140 are sometimes referred to as the long side direction and the short side direction, respectively. Also, both sides in the long side direction are sometimes referred to as one side and the other side.

[0045] The drain catheter 100 is used, for example, as follows: The distal ends of the fluid collection section 110 and the transition section 140 of the drain catheter 100 are placed inside the body (pleural cavity, abdominal cavity, wound, etc.), particularly between organs, while the proximal end of the transition section 140 and the drainage section 160 are placed outside the body. The proximal end of the drainage section 160 is then connected to a storage bag, suction device, etc., via a connector to drain the exudate accumulated inside the body to the outside.

[0046] The drain catheter 100 is equipped with a main channel 101 that extends axially along the entire length of the fluid collection section 110, the transition section 140, and the drainage section 160. The main channel 101 is composed of a main lumen 101A, a central lumen 101B, and a drainage section lumen 101C, which will be described later. These lumens are smoothly connected to each other to form a single main channel 101. The main channel 101 functions as one of the channels that guide exudate and other fluids when the drain catheter 100 is placed in the body.

[0047] Furthermore, the drain catheter 100 may be replaced with a drain catheter of a different size depending on the healing state of the wound. In this case, the drain catheter 100 is cut at the transition section 140, and a guidewire is inserted through the central lumen 101B of the transition section 140 to the main lumen 101A of the fluid collection section 110. After removing the old drain catheter 100, the new drain catheter is placed in the body via the guidewire. Therefore, among the lumens constituting the main flow path 101, the main lumen 101A and the central lumen 101B also function as guidewire lumens for inserting the guidewire used in the replacement procedure.

[0048] The material of the drain catheter 100 is not particularly limited and may be a biocompatible material commonly used for drain catheters. Specifically, for example, the drain catheter 100 may be made of a resin material such as polyurethane, polyvinyl chloride, polyamide, polycarbonate, or polyethylene.

[0049] Furthermore, since the liquid collection unit 110 is a part that is implanted in the body, it is preferable that it be made of a resin material containing a contrast agent such as barium. This improves the visibility of the liquid collection unit 110 implanted in the body under X-ray fluoroscopy.

[0050] Furthermore, since the proximal portion of the transition section 140 is left inside the body, it may also be equipped with a marker portion made of a resin material containing a contrast agent such as barium, as will be described later.

[0051] Furthermore, the drain catheter 100 may be subjected to various biocompatible treatments on at least one of its inner and outer surfaces in order to more effectively prevent foreign body reactions from occurring when it comes into contact with body fluids and tissues while it is placed in a living organ. An example of a biocompatible treatment is an antithrombotic treatment to prevent the formation of a thrombus when it comes into contact with blood while it is placed. The antithrombotic treatment is not particularly limited, but it can be a method of immobilizing or coating with an antithrombotic polymer, a method of immobilizing a plasminogen activator such as urokinase, or a method of immobilizing or coating with an anticoagulant such as heparin.

[0052] [Liquid collection section] The fluid collection unit 110 is a part that is placed inside the body and is used to collect exudate and other fluids.

[0053] As described above, the liquid collection section 110 has a main lumen 101A that forms the main flow path 101. The main lumen 101A is provided along the entire axial length of the liquid collection section 110.

[0054] As shown in Figure 1, the fluid collection section 110 is composed of a first fluid collection section 110A including the distal end of the drain catheter 100, a second fluid collection section 110B (proximal end) connected to the proximal end of the first fluid collection section 110A, and a third fluid collection section 110C (proximal end) connected to the proximal end of the second fluid collection section 110B.

[0055] Specifically, the section where the first groove 111 and the second groove 112, described later, are located together will be referred to as the first liquid collection section 110A. The section where the first lumen 121 and the second groove 112, described later, are located together will be referred to as the second liquid collection section 110B. Furthermore, the section where the first lumen 121 and the second lumen 132, described later, are located together will be referred to as the third liquid collection section 110C.

[0056] Figures 2 to 4 show radial cross-sections of the first liquid collection section 110A, the second liquid collection section 110B, and the third liquid collection section 110C, respectively. The proximal end of the third liquid collection section 110C is the proximal end of the liquid collection section 110 and is connected to the distal end of the transition section 140.

[0057] As shown in Figures 1 and 2, the liquid collection section 110 has two partition wall sections 105 that are erected outward from the outer wall 102A of the main lumen 101A and extend in the axial direction. The two partition wall sections 105 are provided at mutually opposing positions on the outer wall 102A of the main lumen 101A.

[0058] Each of the two partition walls 105 comprises a space formed by the partition wall 105 and includes a first groove 111 that extends in the axial direction.

[0059] In detail, each of the two partition sections 105 has a first partition 113, two second partitions 114, and two third partitions 115.

[0060] The first bulkhead 113 is connected to the outer wall 102A of the main lumen 101A. The second bulkhead 114 extends further outward from the tip 113A of the first bulkhead 113. The third bulkhead 115 extends further outward from the respective tips 114A of the two second bulkheads 114.

[0061] The first groove 111 consists of a space enclosed by two second partitions 114 and two third partitions 115. The first groove 111 functions as a flow path for collecting exudate and other fluids when the drain catheter 100 is placed inside the body.

[0062] In this configuration, two partition walls, each containing a first groove 111, are provided on the outer wall 102A of the main lumen 101A at opposing positions. That is, in the liquid collection section 110, the main lumen 101A is positioned between the two first grooves 111. As a result, in the radial cross-section of the first liquid collection section 110A, the main lumen 101A is positioned in the center of the long side, so that the shape of the liquid collection section 110 can be stably maintained even if the wall thickness of the liquid collection section 110 is reduced. Furthermore, by reducing the wall thickness of the liquid collection section 110, a sufficient flow area can be secured in the liquid collection section 110. Moreover, if a sufficient flow area can be secured in the liquid collection section 110 by thinning the wall thickness of the liquid collection section 110, the size of the liquid collection section 110 can be reduced, which also leads to a reduction in the burden on the patient.

[0063] Furthermore, in this configuration, the first groove 111 is included in the partition wall 105. Specifically, as described above, the first groove 111 is formed by the two second partition walls 114 and the two third partition walls 115 that constitute the partition wall 105; therefore, the outer wall 102A that forms the main lumen 101A does not form the first groove 111.

[0064] As a result, the first groove 111 is less susceptible to the deformation of the main lumen 101A. That is, even if an external force acts on the outer wall 102A forming the main lumen 101A from both sides in the short-side direction, such that the main lumen 101A is crushed, the effect of the deformation of the main lumen 101A on reaching the first groove 111 can be suppressed. In this way, the deformation of the first groove 111 can be suppressed and its shape can be maintained to some extent, so even if the main lumen 101A is crushed, the flow path of the first groove 111 can be secured.

[0065] The thickness of the liquid collection section 110 is not particularly limited, but can be, for example, 0.1 mm or more and 0.7 mm or less.

[0066] Furthermore, each of the two third bulkheads 115A ends 115A forms a first slit 111A that extends in the axial direction. Specifically, each of the two third bulkheads 115A ends 115A has a curved portion 115B that extends toward each other. The first slit 111A is formed by the ends of the opposing curved portions 115B.

[0067] The exudate and other fluids are guided into the first groove 111 through the first slit 111A. This makes it less likely for blockages to occur in the first groove 111, and enables effective discharge of the exudate and other fluids. Furthermore, even if an external force acts on the liquid collection section 110 from both sides in the short direction, such that the liquid collection section 110 is crushed, the tips of the curved sections 115B interfere with each other, making it less likely for the space in the first groove 111 to collapse and ensuring a flow path.

[0068] Furthermore, the liquid collection section 110 consists of a space formed by the partition wall section 105 and the outer wall 102A of the main lumen 101A, and includes four second grooves 112 that extend in the axial direction.

[0069] More specifically, each of the two bulkhead sections 105 further has two fourth bulkheads 116 that are connected to the respective tip portions 114A of the two second bulkheads 114 and extend toward the main lumen 101A side.

[0070] The second groove 112 consists of a space enclosed by the first septum 113, the second septum 114, the fourth septum 116, and the outer wall 102A of the main lumen 101A. Four second grooves 112 are formed on the outer circumference of the main lumen 101A. Like the first groove 111, the second grooves 112 also function as a flow path for collecting exudate and other fluids when the drain catheter 100 is placed inside the body.

[0071] With this configuration, in addition to the first groove 111, exudate can also be sucked from the second groove 112 around the main lumen 101A, so that exudate and the like around the main lumen 101A can be efficiently sucked. In particular, the first groove 111 can suck up exudate and the like that accumulated on both sides in the long direction of the fluid collection section 110, and the second groove 112 can suck up exudate and the like that accumulated on both sides in the short direction of the fluid collection section 110, so that exudate and the like around the fluid collection section 110 can be efficiently discharged.

[0072] In the drain catheter 100 of this example, the first septum 113 and the two second septums 114 are arranged in a Y-shape in the radial cross-section of the first fluid collection section 110A, preferably the first fluid collection section 110A and the second fluid collection section 110B.

[0073] With this configuration, the first partition wall 113 and the two second partition walls 114 are arranged in a Y-shape, so that these partition walls are formed in a balanced manner when the liquid collection section 110 is molded. In this way, even if the liquid collection section 110 is made thinner, the shape of the first groove 111 and the second groove 112, preferably the first groove 111, the second groove 112, and the first lumen 121 can be reliably maintained.

[0074] Furthermore, because the first septum 113 and the two second septums 114 are arranged in a Y-shape, the septum section 105 has appropriate flexibility. This allows the fluid collection section 110 to deform to conform to the surrounding shape while maintaining the flow path of the first groove section 111 when placed in a narrow area such as between organs. In this way, effective drainage of exudate and other fluids and reduction of the burden on the patient can be achieved simultaneously.

[0075] Furthermore, the angle α between the two second partitions 114 on the sides where the first partition 113 is absent is preferably 50° or more and less than 180°, more preferably 55° or more and 150° or less, and particularly preferably 60° or more and 120° or less. If the angle α is less than 50°, the shape of the first groove 111 may not be maintained during molding and use, and the flow rate may not be secured. If the angle α is 180° or more, for example, if an external force is applied to the liquid collection section 110 from both sides in the short-side direction, the liquid collection section 110 may become easily crushed. In addition, the thickness of the liquid collection section 110, and by extension the entire drain catheter 100, in the short-side direction may increase. Furthermore, especially during molding, it may become difficult to form the first slit 111A and the second slit 112A, and the shapes of the first groove 111 and the second groove 112 may not be formed properly.

[0076] By setting the angle α within the above range, the shape of the first groove 111 and the second groove 112 can be formed and maintained in a balanced manner while suppressing an increase in the thickness in the short-side direction of the liquid collection section 110. In addition, the partition wall 105 can be given appropriate flexibility. Furthermore, it is possible to create a structure that is less likely to collapse even when placed in locations where external forces are likely to act, such as between organs, and the flow path can be secured.

[0077] As shown in Figure 2, it is preferable that the two partition walls 105 are arranged symmetrically with respect to the main lumen 101A, that is, with respect to a plane P1 that includes the axis of the main lumen 101A and is parallel to the short side direction. Furthermore, it is more preferable that the first liquid collection section 110A has a structure that is symmetrical with respect to plane P1.

[0078] Furthermore, it is preferable that the first liquid collection section 110A includes the axis of the main lumen 101A and has a structure that is symmetrical with respect to a plane P2 parallel to the direction of the long side.

[0079] In this configuration, the main lumen 101A is positioned in the center, sandwiched between two partition walls 105, in the radial cross-section, thus maintaining the shape of the liquid collection section 110 more stably. In this configuration, two first grooves 111 are positioned on both sides of the main lumen 101A, and four second grooves 112 are regularly arranged around the outer circumference of the main lumen 101A. That is, the first grooves 111 and second grooves 112 are balanced and arranged around the main lumen 101A. As a result, exudate and the like can be sucked from both sides of the main lumen 101A in the long-side direction through the first grooves 111, and from both sides of the main lumen 101A in the short-side direction through the second grooves 112. In other words, compared to cases such as when the main lumen 101A is positioned at the end in the long-side direction, exudate and the like can be effectively collected over the entire circumference of the main lumen 101A.

[0080] If we let β be the smaller of the angles between each of the two second partitions 114 and the first partition 113, then if the liquid collection section 110 has a symmetrical shape with respect to planes P1 and P2, the relationship α + 2β = 360° holds between angle α and angle β.

[0081] Furthermore, it is preferable that the third partition wall 115 and the fourth partition wall 116 extend in opposite directions from the tip portion 114A of the second partition wall 114. In other words, it is preferable that the sum of the angle γ between the second partition wall 114 and the third partition wall 115 and the angle δ between the second partition wall 114 and the fourth partition wall 116 is, for example, 150° or more and 210° or less. This allows the shapes of the first groove portion 111 and the second groove portion 112 to be more stably maintained during molding and use.

[0082] Preferably, the flow area of ​​each of the two first grooves 111 is about the same as the flow area of ​​the main lumen 101A.

[0083] Furthermore, it is preferable that the sum of the flow area of ​​the four second grooves 112 is approximately the same as the flow area of ​​the main lumen 101A.

[0084] This ensures a sufficient flow rate for exudate and other fluids that can be drawn in through the first groove 111 and the second groove 112, in addition to the main lumen 101A. In this case, "similar flow area" means that, in the radial cross-section of the first liquid collection section 110A, the sum of the flow area of ​​each of the two first grooves 111 or the flow area of ​​the four second grooves 112 is, for example, 60% to 120% of the flow area of ​​the main lumen 101A.

[0085] Furthermore, it is preferable that the sum of the flow area of ​​the four second grooves 112 is about the same as the flow area of ​​each of the two first grooves 111. This configuration allows for a sufficient flow rate of exudate and the like that can be aspirated through the first grooves 111 and the second grooves 112, while suppressing an increase in the thickness of the liquid collection section 110 in the short-side direction. In this case, "similar flow area" means that, in the radial cross-section of the first liquid collection section 110A, the sum of the flow area of ​​the four second grooves 112 is, for example, 60% to 120% of the flow area of ​​each of the two first grooves 111.

[0086] The inner diameter of the main lumen 101A is not particularly limited, as long as a commonly used guide wire can be inserted with ample clearance. This inner diameter can be, for example, approximately twice the length of the guide wire, specifically, for example, 1.3 mm to 2.5 mm.

[0087] The second liquid collection section 110B and the third liquid collection section 110C are provided for connecting the first liquid collection section 110A and the transition section 140. The third liquid collection section 110C includes the proximal end of the liquid collection section 110.

[0088] As shown in Figure 3, the second liquid collection section 110B and the third liquid collection section 110C include a first lumen 121 formed by two second partitions 114 and two third partitions 115, where the tips 115A of two third partitions 115 are connected to each other. There are two first lumens 121, one on each side in the long-side direction of the main lumen 101A, corresponding to the two first grooves 111. The distal end of each of the two first lumens 121 is connected to the proximal end of each of the two first grooves 111. The first lumens 121 are provided along the entire axial length of the second liquid collection section 110B and the third liquid collection section 110C.

[0089] The proximal end of the fluid collection section 110 is connected to the transition section 140. By providing the first lumen 121 in the second fluid collection section 110B and the third fluid collection section 110C, the hardness of the drain catheter 100 can be changed in stages from the fluid collection section 110 to the transition section 140. This improves the kink resistance at the connection point between the fluid collection section 110 and the transition section 140.

[0090] Furthermore, as shown in Figure 4, the third liquid collection section 110C includes a second lumen 132 formed by the first partition wall 113, the second partition wall 114, the fourth partition wall 116, and the outer wall 102A of the main lumen 101A, with the tip 116A of the fourth partition wall 116 connected to the outer wall 102A of the main lumen 101A. There are four second lumens 132, corresponding to the four second grooves 112. The distal end of each of the four second lumens 132 is connected to the proximal end of each of the four second grooves 112. The second lumens 132 are provided along the entire axial length of the third liquid collection section 110C.

[0091] According to this configuration, by forming a second lumen 132 on the proximal end side of the second groove 112, connection to the lumen formed in the transition section 140 (side lumen 143, described later) becomes easier, and the abrupt change in hardness from the liquid collection section 110 to the transition section 140 is suppressed, improving kink resistance. Note that the second lumen 132 is not an essential component, and the proximal end of the second groove 112 may be directly connected to the side lumen 143.

[0092] The axial length of the second lumen 132 is preferably shorter than the axial length of the first lumen 121. In other words, the axial length of the first lumen 121 is preferably longer than the axial length of the second lumen 132.

[0093] By providing the second lumen 132, a smooth connection is obtained from the first groove 111 to the side lumen 143 of the transition section 140. On the other hand, because the second lumen 132 is formed by closing the second slit 112A, the flow area of ​​the second lumen 132 tends to be smaller than that of the second groove 112. Also, since the drain catheter 100 is flat, and from the viewpoint of suppressing an increase in thickness in the short-side direction and preventing an increase in the diameter of the fluid collection section 110, the flow area of ​​the second groove 112 is set to be smaller than that of the main lumen 101A and the first groove 111. Therefore, if the axial length of the second lumen 132 is increased, the risk of occlusion in the second lumen 132 increases.

[0094] While increasing the axial length of the second lumen 132 may improve kink resistance, sufficient kink resistance can be ensured simply by increasing the axial length of the first lumen 121. Therefore, in this configuration, the axial length of the second lumen 132 is shortened to suppress the risk of blockage in the second lumen 132 while enabling a smooth connection of the transition section 140 to the side lumen 143.

[0095] Specifically, for example, the axial length of the first lumen 121 can be 1.8 times or more and 10 times or less the axial length of the second lumen 132.

[0096] The axial length of the first lumen 121 is preferably, for example, 5 mm to 20 mm, from the viewpoint of improving kink resistance at the connection between the liquid collection section 110 and the transition section 140.

[0097] The axial length of the second lumen 132 is preferably, for example, 1 mm or more and less than 5 mm, from the viewpoint of suppressing the risk of blockage in the second lumen 132 while obtaining a smooth connection of the transition section 140 to the side lumen 143.

[0098] In Figures 3 and 4, the radial cross-sectional shapes of the first lumen 121 and the second lumen 132 are shown as approximately circular, but these shapes are not limited to circular; for example, they may be rectangular, polygonal, or the like.

[0099] [Transition Section] The transition section 140 connects the liquid collection section 110 and the liquid drainage section 160. Specifically, the distal end of the transition section 140 is connected to the proximal end of the liquid collection section 110, and the proximal end of the transition section 140 is connected to the distal end of the liquid drainage section 160.

[0100] An example of the configuration of the transition section 140 is the configuration of the transition section 140 of the drain catheter 100 according to Embodiment 2, which will be described later, but it is not limited to the configuration of Embodiment 2. As for the configuration of the transition section 140, the configuration of a conventional drain catheter transition section may be adopted.

[0101] [Drainage section] As described above, the drainage section 160 is located outside the body and is connected to a storage bag, suction device, etc.

[0102] Figure 5 shows a radial cross-section of the drainage section 160. The drainage section 160 has a single-lumen structure and includes a drainage section lumen 101C that forms the main flow path 101.

[0103] The drainage section 160 is composed of a proximal first drainage section 160A and a distal second drainage section 160B.

[0104] The first drain section 160A includes the distal end of the drain section 160 and is connected to the proximal end of the transition section 140. The inner diameter of the first drain section 160A is set to be larger than the inner diameter of the second drain section 160B. The drain section lumen 101C is connected to the central lumen 101B and side lumens 143 of the transition section 140. In other words, the central lumen 101B and side lumens 143 are combined into a single drain section lumen 101C in the first drain section 160A.

[0105] With this configuration, the exudate collected through the main lumen 101A, first groove 111, and second groove 112 of the fluid collection section 110 is discharged outside the body through the first lumen 121, second lumen 132, central lumen 101B, side lumen 143, and drainage section lumen 101C.

[0106] In Figure 1, a stepped portion is provided at the connection between the first drainage section 160A and the second drainage section 160B, but the configuration is not limited to this, and the stepped portion does not need to be formed.

[0107] <Manufacturing method for drain catheters> The manufacturing method for the drain catheter 100 is not particularly limited, and known methods can be used as appropriate.

[0108] Specifically, for example, the liquid collection section 110 and the transition section 140 may be molded separately and then fixed to each other by means of adhesive bonding or heat welding. The liquid collection section 110 and the transition section 140 can each be obtained by molding by extrusion molding or the like. Alternatively, the liquid collection section 110 and the transition section 140 may be integrally molded.

[0109] The drainage section 160 is not particularly limited; for example, commercially available tubing or other materials commonly used in drain catheters can be used. The drainage section 160 and the transition section 140 can also be fixed together by means of adhesive or heat welding.

[0110] When applying the biocompatibility treatment described above, the entire drain catheter 100 should be treated after the fluid collection section 110, the transfer section 140, and the drainage section 160 have been fixed in place.

[0111] (Embodiment 2) Other embodiments relating to this disclosure will be described in detail below. In the description of these embodiments, the same reference numerals are used for parts that are the same as in Embodiment 1, and detailed descriptions will be omitted.

[0112] [Liquid collection section] An example of the fluid collection section 110 of the drain catheter 100 according to this embodiment is the fluid collection section 110 of Embodiment 1, but it is not limited to the configuration of Embodiment 1 as long as it has a main lumen 101A and a plurality of grooves. A conventional drain catheter fluid collection section configuration may also be adopted.

[0113] In the following description, the liquid collection unit 110 will be described assuming it has the configuration of Embodiment 1.

[0114] [Transition Section] The drain catheter 100 according to this embodiment is characterized by the configuration of the transition section 140.

[0115] The transition section 140 connects the liquid collection section 110 and the liquid drainage section 160. Specifically, the distal end of the transition section 140 is connected to the proximal end of the liquid collection section 110, and the proximal end of the transition section 140 is connected to the distal end of the liquid drainage section 160.

[0116] As described above, when the drain catheter 100 is placed inside the body, the transition section 140 is positioned with its distal portion inside the body and its proximal portion outside the body. During the collection of exudate by the drain catheter 100, the transition section 140 is fixed to the body. Therefore, the thickness of the transition section 140 is configured to be thicker than that of the fluid collection section 110 in order to improve kink resistance. Specifically, for example, the thickness of the transition section 140 can be about 1.1 to 5.0 times that of the fluid collection section 110.

[0117] Figure 6 shows a radial cross-section of the transition section 140. As shown in Figure 6, the transition section 140 has a triple lumen structure and includes a central lumen 101B connected to the main lumen 101A to form the main flow path 101, and two side lumens 143 positioned to the sides of the central lumen 101B.

[0118] The side lumens 143 are arranged one on each side of the central lumen 101B. Of the two side lumens 143, the one located on one side is referred to as the first side lumen 143A, and the one located on the other side is referred to as the second side lumen 143B.

[0119] As shown in Figure 1, the first side lumen 143A located on one side is connected to the first lumen 121 and the two second lumens 132 located on the other side. In other words, the first lumen 121 and the two second lumens 132 located on one side are concentrated in the first side lumen 143A. Thus, the first side lumen 143A is connected to the first groove 111 and the two second grooves 112 located on one side of the main lumen 101A in the liquid collection section 110.

[0120] Furthermore, the second side lumen 143B located on the other side is connected to the first lumen 121 and the two second lumens 132 located on the other side. In other words, the first lumen 121 and the two second lumens 132 located on the other side are concentrated in the second side lumen 143B. Thus, the second side lumen 143B is connected to the first groove 111 and the two second grooves 112 located on the other side of the main lumen 101A in the liquid collection section 110.

[0121] The triple-lumen structure of the transition section 140 ensures sufficient flow area in each lumen of the transition section 140. This ensures sufficient flow rate when using the drain catheter 100 and reduces the risk of flow path blockage. Furthermore, since the first groove 111 and the second groove 112 are connected to the side lumen 143 of the transition section 140 via the first lumen 121 and the second lumen 132, exudate and other fluids around the fluid collection section 110 can be efficiently aspirated.

[0122] Furthermore, in the radial cross-section of the transition section, it is preferable that the first side lumen 143A and the second side lumen 143B are arranged symmetrically with respect to the central lumen 101B.

[0123] As a result, when the liquid collection section 110 has a symmetrical shape with respect to planes P1 and P2, as described above, it becomes easier to connect the first lumen 121 and the second lumen 132 to the side lumen 143.

[0124] As mentioned above, the drain catheter 100 may be replaced with a drain catheter of a different size depending on the healing state of the wound. In this case, the drain catheter 100 is cut at the transition section 140, and a guide wire is inserted through the central lumen 101B of the transition section 140 into the main lumen 101A of the fluid collection section 110. Therefore, the main lumen 101A and the central lumen 101B also function as guide wire lumens for inserting the guide wire used in the replacement procedure.

[0125] If a guidewire is inserted into a lumen having a slit, such as the first groove 111 or the second groove 112, there is a risk of tissue damage due to the guidewire protruding from the lumen. Therefore, it is desirable that the lumen through which the guidewire is inserted, i.e., the guidewire lumen, be a lumen without slits along the entire length of the fluid collection section 110. In this configuration, the central lumen 101B is located in the center of the three lumens of the transition section 140. Therefore, compared to cases where the transition section 140 has four or more lumens, or where the guidewire lumen is formed on one side or the other side in the long-side direction, the possibility of incorrect guidewire insertion is reduced.

[0126] The transition section 140 has, in its radial cross-section, two first wall portions 141 arranged on both sides in the long-side direction and forming the first side lumen 143A and the second side lumen 143B, respectively, and four second wall portions 142 arranged on both sides in the short-side direction and forming the first side lumen 143A and the second side lumen 143B, respectively.

[0127] The thickness T1 of the first wall portion 141 is preferably greater than the thickness T2 of the second wall portion 142.

[0128] As described above, when the drain catheter 100 is used, the transition section 140 is secured to the patient's skin by being sutured with thread or the like. When the horizontally elongated transition section 140 is tied with thread or the like, the load applied to both sides in the long direction tends to be greater than the load applied to both sides in the short direction. The thickness T1 of the first wall 141 is greater than the thickness T2 of the second wall 142, which improves the kink resistance of the transition section 140. In this way, the risk of the transition section 140 being crushed and the flow path being blocked when the transition section 140 is tied with thread or the like can be reduced.

[0129] Specifically, for example, the thickness T1 of the first wall portion 141 can be 1.3 times or more and 3 times or less, preferably 1.5 times or more and 2.5 times or less, the thickness T2 of the second wall portion 142.

[0130] The transition section 140 preferably has a main body 144 made of a transparent or translucent resin material and a marker section 145 made of a resin material containing a contrast agent such as barium, which is provided on the main body 144.

[0131] The transparent or semi-transparent nature of the main body 144 allows for visual confirmation of the color, condition, and other characteristics of the exudate guided through the flow path. Furthermore, the inclusion of the marker portion 145 improves the visibility of the implanted portion under X-ray fluoroscopy.

[0132] It is preferable that the marker portion 145 is provided along the entire length of the transition portion 140 on the outer wall 102B that forms the central lumen 101B.

[0133] Since the marker portion 145 is provided along the entire length of the transition portion 140, visibility inside the body under X-ray fluoroscopy can be improved regardless of the proportion of the transition portion 140 that is implanted in the body. Furthermore, since the marker portion 145 is provided on the outer wall 102B that forms the central lumen 101B, that is, in the center of the long side direction of the outer wall that forms the transition portion 140, visibility inside the body under X-ray fluoroscopy can be further improved.

[0134] Furthermore, if the entire liquid collection section 110 is made of a resin material containing a contrast agent such as barium, the transition section 140 having a main body section 144 and a marker section 145 improves the visibility of the boundary between the liquid collection section 110 and the transition section 140 under X-ray fluoroscopy.

[0135] In Figure 6, the radial cross-sectional shape of the central lumen 101B is depicted as approximately circular. The radial cross-sectional shape of the side lumen 143 is depicted as approximately rectangular. The radial cross-sectional shapes of the central lumen 101B and the side lumen 143 are not limited to the above shapes; they may be circular, rectangular, polygonal, or other shapes. However, from the viewpoint of increasing the flow area, an approximately rectangular radial cross-sectional shape of the side lumen 143 is preferable. [Industrial applicability]

[0136] This disclosure is extremely useful because it can provide a drain catheter that can stably maintain its shape while ensuring a sufficient flow area. [Explanation of symbols]

[0137] 100 Drain Catheters 101 Main channel 101A Main Lumens 101B Central Lumen 102A (Main Lumen) Exterior Wall 102B (Central Lumen) Exterior Wall 105 Bulkhead 110 Liquid collection section 110A 1st liquid collection section 110B Second liquid collection section (proximal end) 110C Third liquid collection section (proximal end) 111 First groove 111A First Slit 112 Second trench section 113 1st bulkhead 114 Second bulkhead 115 Third bulkhead 115B Curved section 116 4th Bulkhead 121 Lumens 132 lumens (2nd lumen) 140 Transition Section 141 1st wall section 142 Second wall section 143 side lumens 143A First side lumen 143B Second side lumen 144 Main body 145 Marker section 160 Drainage section

Claims

1. liquid collection section, A transition section provided on the proximal side of the liquid collection section, A drainage section is provided on the proximal side of the transition section, A flat-type drain catheter comprising a main channel extending axially along the entire length of the liquid collection section, the transition section, and the drainage section, The aforementioned liquid collection unit is The main lumen that forms the main flow path, In the radial cross-section, the main lumen's outer wall is erected facing each other at opposing positions and has two partition wall sections that extend axially. Each of the two partition walls includes a first groove extending in the axial direction. The partition wall portion, in its radial cross-section, A first partition wall connected to the outer wall of the main lumen, Two second bulkheads extending further outward from the tip of the first bulkhead, It has two third partitions that extend outward from the respective ends of the two second partitions, The drain catheter is characterized in that the first groove portion is a space enclosed by the two second partitions and the two third partitions.

2. The drain catheter according to claim 1, wherein the first partition and the two second partitions are arranged in a Y-shape in a radial cross-section.

3. The drain catheter according to claim 2, wherein the angle between the two second partitions on the sides where the first partition is absent is 60° or more and less than 180°.

4. Each of the two third partition walls has a curved section extending toward the direction toward the other, A drain catheter according to claim 1 or claim 2, wherein a first slit extending in the axial direction is formed at the tip of the curved portion.

5. The drain catheter according to claim 1 or claim 2, wherein the proximal end of the fluid collection portion is formed by the two second partitions and the two third partitions by the connection of the tips of the two third partitions, and includes a first lumen connected to the first groove.

6. The partition wall portion further has a fourth partition wall in its radial cross-section that is connected to the tip of the second partition wall and extends toward the main lumen side. The drain catheter according to claim 1 or claim 2, wherein the liquid collection section further comprises a space enclosed by the first partition, the second partition, the fourth partition, and the outer wall of the main lumen, and has a second groove extending in the axial direction.

7. The proximal end of the liquid collection section is formed by the two second partitions and the two third partitions, with the tips of the two third partitions connected to each other, and includes a first lumen connected to the first groove. The drain catheter according to claim 6, wherein the proximal end of the liquid collection portion is formed by the first partition, the second partition, the fourth partition and the outer wall of the main lumen, with the tip of the fourth partition connected to the outer wall of the main lumen, and includes a second lumen connected to the second groove.

8. The drain catheter according to claim 7, wherein the axial length of the second lumen is shorter than the axial length of the first lumen.

9. The aforementioned transition section is A central lumen connected to the main lumen and forming the main flow path, It has side lumens positioned to the side of the central lumen, The drain catheter according to claim 7, wherein the side lumen is connected to the first lumen and the second lumen.

10. The drain catheter according to claim 1 or claim 2, wherein the liquid collection section is made of a resin material containing barium.

11. The drain catheter according to claim 1 or claim 2, wherein the outer wall forming the main lumen does not have the first groove portion formed thereon.

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