Percutaneous catheter and medical instrument set

Abstract

[Problem] To provide a percutaneous catheter excellent in antithrombogenicity while maintaining insertability into a blood vessel, and a medical instrument set. [Solution] A cannula body 110 includes: a lumen 120 through which blood can flow; a tip opening 112 communicating with the lumen; at least one or more side holes 130 formed at predetermined positions between the tip 111 and the base end 113 of the cannula body and communicating with the lumen; and a lubricant coat layer 140 provided over a predetermined range from the tip side to the base end 113 side of the cannula body. The lubricant coat layer is not provided on a peripheral part 130b surrounding the periphery of the side hole in a plan view of the side hole.

Description

Percutaneous catheters and medical instrument sets

[0001] The present invention relates to a percutaneous catheter and a medical instrument set.

[0002] Conventionally, percutaneous cardiopulmonary support (PCPS) has been used to perform cardiopulmonary resuscitation, circulatory support, respiratory support, etc. in emergency treatment. PCPS is a method of temporarily supporting or substituting for cardiopulmonary function using an extracorporeal membrane oxygenation (ECMO) device.

[0003] The extracorporeal circulation device includes an extracorporeal circulation circuit composed of a centrifugal pump, an artificial lung, a blood removal channel, a blood transfer channel, etc., and performs gas exchange on the removed blood before transferring it to the blood transfer channel.

[0004] The blood removal and blood return paths of such an extracorporeal circuit can use, for example, a percutaneous catheter as disclosed in Patent Document 1. The percutaneous catheter disclosed in Patent Document 1 comprises a cannula body provided with a lumen through which blood can flow and a side hole (blood removal hole) that connects the inside and outside of the lumen.

[0005] WO2018 / 013644

[0006] In percutaneous catheters such as those described above, a lubricating coating layer may be provided on the cannula body to facilitate insertion into a blood vessel. However, if the side hole is entirely covered with the lubricating coating layer, it may impede the smooth flow of blood through the side hole. This makes it difficult to maintain antithrombotic properties in the area around the side hole.

[0007] The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a percutaneous catheter and a medical instrument set that are excellent in antithrombotic properties while maintaining ease of insertion into blood vessels.

[0008] The above object of the present invention can be achieved by the following means.

[0009] (1) A percutaneous catheter comprising an axially extending cannula body, the cannula body having: a lumen through which blood can flow; a tip opening communicating with the lumen; at least one side hole formed at a predetermined position between the tip and base ends of the cannula body and communicating with the lumen; and a lubricating coating layer provided in a predetermined range from the tip end side to the base end side of the cannula body, wherein the lubricating coating layer is not provided on the inner circumferential surface of the side hole.

[0010] (2) The percutaneous catheter according to (1) above, wherein the lubricating coating layer is not provided in the peripheral area surrounding the periphery of the side hole when the side hole is viewed in plan.

[0011] (3) The percutaneous catheter according to (1) above, wherein the lubricating coating layer is not provided near the outer peripheral edge of the side hole or on the side wall of the side hole.

[0012] (4) The percutaneous catheter according to (2) or (3), characterized in that an antithrombosis coating layer is disposed in the peripheral portion, and the lubricating coating layer and the antithrombosis coating layer disposed so as to cover the lubricating coating layer are disposed at a position farther from the side hole than the peripheral portion.

[0013] (5) The percutaneous catheter according to (2) or (3) above, characterized in that the cannula body is further provided with a coating layer made of an antithrombogenic coating material, and a mixed layer in which the lubricating coating layer and the antithrombogenic coating material are mixed is formed at a position farther from the side hole than the peripheral portion.

[0014] (6) A percutaneous catheter according to any one of (1) to (5) above, wherein a plurality of the side holes are provided so as to face each other across the axis of the cannula body, and the lubricating coating layer extends in a linear pattern along the axial direction of the cannula body so as not to overlap with the plurality of side holes, or in a spiral pattern based on the axis so as not to overlap with the plurality of side holes.

[0015] (7) A percutaneous catheter according to any one of (1) to (6) above, characterized in that the cannula body has a distal region provided in a predetermined range from the distal end where the distal opening is located toward the proximal end, an intermediate region provided in a predetermined range from the proximal end of the distal region toward the proximal end, and a proximal region provided in a predetermined range from the proximal end of the intermediate region toward the proximal end, wherein at least one or more side holes are formed in each of the distal region, intermediate region, and proximal region, and the distal region and intermediate region have a larger number of side holes and / or larger diameters of the side holes than the proximal region.

[0016] (8) The percutaneous catheter according to any one of (1) to (7) above, wherein the lumen is configured to allow a dilator to be inserted therein, and the dilator has a step suppressing portion that suppresses the formation of a step between the edge of the tip opening and the dilator protruding from the tip opening when the dilator is inserted into the lumen.

[0017] (9) A medical instrument set comprising: the percutaneous catheter according to any one of (1) to (8) above; and a tray capable of holding a liquid to be brought into contact with the lubricating coating layer of the cannula body, wherein the tray has: a housing portion capable of housing the tip end of the cannula body on which the lubricating coating layer is disposed; an insertion portion that allows the cannula body to be inserted into the housing portion; and a fixing portion that can fix the tip end of the cannula body.

[0018] According to the percutaneous catheter of (1) above, the lubricating coating layer provided in a predetermined range from the distal end to the proximal end of the cannula body can improve the ease of insertion of the percutaneous catheter into a blood vessel. Furthermore, the percutaneous catheter of (1) above does not have a lubricating coating layer provided on the inner circumferential surface of the side hole, so that the movement of blood into and out of the lumen via the side hole is prevented from being hindered by the lubricating coating layer, and excellent antithrombotic properties can be exhibited.

[0019] 6E. FIG. 6E is a view showing a catheter assembly according to an embodiment. FIG. 6E is a perspective view showing an enlarged view of the vicinity of the base end of the percutaneous catheter. FIG. 6F is a view showing a state in which a dilator is inserted into the percutaneous catheter. FIG. 6G is a plan view showing an enlarged view of a side hole formed in the cannula body. FIG. 6H is a partial cross-sectional view of the cannula body taken along arrows 5A-5A shown in FIG. 4. FIG. 6I is a plan view illustrating a method of forming a lubricious coating layer. FIG. 6J is a plan view illustrating a method of forming a lubricious coating layer. FIG. 6J is a cross-sectional view of the cannula body taken along arrows 7A-7A shown in FIG. 6E. FIG. 6J is a cross-sectional view of the cannula body taken along arrows 8A-8A shown in FIG. 6E. FIG. 6J is a plan view illustrating a method of forming a lubricious coating layer according to Modification 1. FIG. 6J is a plan view illustrating a method of forming a lubricious coating layer according to Modification 1. FIG. 6J is a plan view illustrating a method of forming a lubricious coating layer according to Modification 2. 11C 。 FIG. 11D is a plan view illustrating a method for forming a lubricating coating layer according to Modification 2. FIG. 11E is a plan view illustrating a method for forming a lubricating coating layer according to Modification 2. FIG. 11F is a plan view illustrating a method for forming a lubricating coating layer according to Modification 3. FIG. 11G is a plan view illustrating a method for forming a lubricating coating layer according to Modification 3. FIG. 11H is a plan view illustrating a method for forming a lubricating coating layer according to Modification 3. FIG. 11H is a cross-sectional view of the cannula body taken along arrows 12A-12A in FIG. 11C . FIG. 11H is a cross-sectional view of the cannula body taken along arrows 13A-13A in FIG. 11C . FIG. 11G is a partial enlarged view of the cannula body according to Modification 4. FIG. 11H is a partial enlarged view of the cannula body according to Modification 5. FIG. 11G is a view showing a cannula body according to an embodiment. FIG. 11H is a view illustrating the relationship between the inner diameter of the cannula body and the outer diameter of the dilator. FIG. 11H is a view illustrating the relationship between the inner diameter of the cannula body and the outer diameter of the dilator. FIG. 11H is a view illustrating a step suppressing section. FIG. 11H is a partial cross-sectional view illustrating the step suppressing section. FIG. 11H is a view illustrating the step suppressing section.Fig. 10 is a diagram for explaining a step suppressing section. Fig. 11 is a diagram for explaining a step suppressing section. Fig. 12 is a diagram for explaining a tray included in the medical instrument set. Fig. 13 is a diagram for explaining a tray included in the medical instrument set. Fig. 14 is a diagram for explaining a modified example of the tray.

[0020] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. Note that the following description does not limit the technical scope or meaning of terms described in the claims. Also, the dimensional proportions in the drawings are exaggerated for the convenience of explanation and may differ from the actual proportions.

[0021] 1 to 3 show a catheter assembly 10 according to an embodiment.

[0022] As shown in FIGS. 1 and 3 , the catheter assembly 10 includes a percutaneous catheter 100 and a dilator (stylet) 200 .

[0023] FIG. 1 shows a state in which the percutaneous catheter 100 and the dilator 200 are separated (before being assembled), and FIG. 3 shows a state in which the percutaneous catheter 100 and the dilator 200 are connected (assembled).

[0024] The catheter assembly 10 can be used in an extracorporeal circulation device used in percutaneous cardiopulmonary support (PCPS). The extracorporeal circulation device is, for example, a device used in a veno-venous (Veno-Veno, VV) procedure in which blood is withdrawn from a vein, oxygenated in an artificial lung, and then returned to the vein. However, the extracorporeal circulation device may also be, for example, a device used in a veno-arterial (Veno-Arterial, VA) procedure in which blood is withdrawn from a vein, oxygenated in an artificial lung, and then returned to an artery.

[0025] The percutaneous catheter 100 can be configured as a blood infusion catheter and / or a blood removal catheter used in a VV procedure. The percutaneous catheter 100 can also be configured as a blood infusion catheter and / or a blood removal catheter used in a VA procedure. In the following, this embodiment will describe an example in which the percutaneous catheter 100 is configured as a blood removal catheter used in a VV procedure.

[0026] The direction in which the cannula body 110 extends (the direction indicated by the arrow X1-X2 in the figure) is defined as the "axial direction." The side of the cannula body 110 that is inserted into a blood vessel (the side indicated by the arrow X1) is defined as the "distal side," and a certain range including the end located on the distal side is defined as the "distal portion." The side of the cannula body 110 opposite the distal side (the side indicated by the arrow X2) is defined as the "proximal side," and a certain range including the end located on the proximal side is defined as the "proximal portion." The clockwise or counterclockwise direction around the axis (central axis) c1 of the cannula body 110 is defined as the "circumferential direction." The definitions of the above directions also apply to the catheter assembly 10 and the dilator 200.

[0027] When the catheter assembly 10 is inserted into a blood vessel, it is prepared in a state in which the percutaneous catheter 100 and the dilator 200 are connected as shown in FIG.

[0028] An operator such as a doctor can prevent bending or kinking of the percutaneous catheter 100 by inserting the percutaneous catheter 100 into a blood vessel with the main body 210 of the dilator 200 inserted into the lumen 120 of the percutaneous catheter 100. The percutaneous catheter 100 and the dilator 200 are configured to be connectable and separable via the connector portion 170 of the percutaneous catheter 100 and the hub portion 220 of the dilator 200.

[0029] When the percutaneous catheter 100 configured as a blood removal catheter is used in a VV procedure, the surgeon inserts the percutaneous catheter 100 through the femoral vein and positions the distal end of the percutaneous catheter 100 (the distal end 111 of the cannula body 110) at the junction between the inferior vena cava and the right atrium. After inserting the percutaneous catheter 100 to a predetermined position in the living body, the surgeon separates and removes the dilator 200 from the percutaneous catheter 100. With the percutaneous catheter 100 placed in the blood vessel, the surgeon connects the percutaneous catheter 100 to a blood removal tube (blood removal line) of an extracorporeal circulation circuit via a connector 170 located at the proximal end of the percutaneous catheter 100. With the percutaneous catheter 100 connected to the blood removal tube, the surgeon operates a centrifugal pump to remove blood from the blood vessel via the distal end opening 112 and the side hole 130 of the cannula body 110.

[0030] As shown in FIGS. 1, 3, 4 and 5, the percutaneous catheter 100 includes an axially extending cannula body 110.

[0031] Cannula body 110 has a lumen 120 through which blood can flow, a tip opening 112 that communicates with lumen 120, at least one side hole 130 that is formed at a predetermined position between tip end 111 and base end 113 of cannula body 110 and communicates with lumen 120, and a lubricating coating layer 140 (see Figures 5, 6E, etc.) that is provided in a predetermined range from tip end 111 to base end 113 of cannula body 110.

[0032] As described above, the percutaneous catheter 100 is configured as a blood removal catheter, and therefore the tip opening 112 and the side hole 130 are used as blood removal holes.

[0033] As shown in Figure 1, side holes 130 are provided in a predetermined range on the distal end 111 side of cannula body 110. In this embodiment, four side holes 131, 132, 133, and 134 are illustrated, but there is no particular limitation on the number of side holes 130 provided in cannula body 110. In the description herein, when side holes 131, 132, 133, and 134 are collectively referred to, they will simply be referred to as "side holes 130."

[0034] As shown in Fig. 8, a plurality of side holes 130 are provided, for example, facing each other across the axis c1 of cannula body 110. In other words, side holes 130 can also be arranged at positions (on the same cross section passing through axis c1) that are angularly offset by 180° in the circumferential direction from side holes 131, 132, 133, 134, and 135 shown in Fig. 1. The number of side holes 130 arranged at the same axial position of cannula body 110 may be one or more, and is not limited to two as shown in Fig. 8.

[0035] Cannula body 110 can be configured as a hollow tubular member having, for example, a resin or metal reinforcing member 115 (e.g., a metal braid wire) and resin layers (e.g., inner and outer resin layers) in which reinforcing member 115 is embedded. A hollow part (metal ring member) for forming side hole 130 can be disposed at the position where side hole 130 is provided in cannula body 110. Cannula body 110 can be configured from a portion where reinforcing member 115 is disposed and multiple hollow parts disposed at predetermined intervals in the axial direction.

[0036] 2, a connection region 175 that is connected to connector portion 170 is disposed at proximal end 113 of cannula body 110. Cannula body 110 and connector portion 170 can be integrally molded from a resin material via connection region 175, for example.

[0037] The connector 170 may be configured to be connectable directly to the blood removal tube of the extracorporeal circulation circuit, or to be connectable to the blood removal tube via a specified attachment. The attachment used has a structure that, when attached to the connector 170, ensures connection compatibility with multiple types of blood removal tubes with different product specifications.

[0038] 1, a protrusion 180 is provided near the proximal end 113 of the cannula body 110. The protrusion 180 can be used to hook a member (e.g., a thread-like member) for the purpose of fixing or maintaining the position of the cannula body 110 while it is placed in a blood vessel.

[0039] 5, the lubricating coating layer 140 is not provided on the inner peripheral surface 130a of the side hole 130 (the inner peripheral surface at the portion penetrated by the cannula body 110). Note that the lubricating coating layer 140 and the antithrombogenic coating layer 150 are not shown in some of the drawings, such as Figures 1 to 3.

[0040] The cannula body 110 has a lubricating coating layer 140 provided in a predetermined axial range including the tip portion 111, which allows for high insertability into blood vessels. Furthermore, the cannula body 110 does not have a lubricating coating layer 140 provided on the inner circumferential surface 130a of the side hole 130, which allows for smooth blood flow through the side hole 130. This makes it possible to prevent the formation of thrombi and the like near the side hole 130.

[0041] As shown in Figure 4, the lubricating coating layer 140 is not provided in the peripheral portion 130b surrounding the periphery of the side hole 130 when the side hole 130 is viewed in plan view. In other words, the lubricating coating layer 140 is not provided near the edge on the outer periphery of the side hole 130 or on the side wall of the side hole 130. Therefore, the cannula body 110 allows smooth blood flow even in the peripheral portion 130b close to the side hole 130.

[0042] 5, an antithrombogenic coating layer 150 is disposed on the peripheral portion 130b. A lubricating coating layer 140 and an antithrombogenic coating layer 150 disposed to cover the lubricating coating layer 140 are disposed at a position farther from the side hole 130 than the peripheral portion 130b.

[0043] 5 , an antithrombogenic coating layer 150 is provided on an area including peripheral portion 130b of outer surface 110a of cannula body 110, a predetermined area of ​​inner surface 110b of cannula body 110, and inner circumferential surface 130a of side hole 130. Lubricious coating layer 140 is not provided on inner surface 110b of cannula body 110.

[0044] Cannula body 110 has antithrombogenic coating layer 150 provided on peripheral portion 130b, which can prevent thrombus formation near side hole 130, which serves as the entrance and exit for blood into and out of lumen 120. Furthermore, cannula body 110 has lubricating coating layer 140 and antithrombogenic coating layer 150 provided at a position farther from side hole 130 than peripheral portion 130b, so lubricating coating layer 140 improves insertability into a blood vessel, while antithrombogenic coating layer 150 can prevent thrombus formation.

[0045] In addition, the cannula body 110 may be provided with a mixed layer (a layer in which the antithrombogenic coating (its constituent materials) are dispersed in the lubricating coating layer 140) in a position farther from the side hole 130 than the peripheral portion 130b of the side hole 130. The mixed layer is a mixture of the lubricating coating layer 140 and the antithrombogenic coating material that is a constituent material of the antithrombogenic coating layer 150.

[0046] There are no particular limitations on the material that constitutes the lubricating coating layer 140, but it may be made of a low-friction material such as a hydrophilic material. Examples of hydrophilic materials include hydrophilic polymers such as cellulose-based polymers, polyethylene oxide-based polymers, maleic anhydride-based polymers (e.g., maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer), acrylamide-based polymers (e.g., polyacrylamide, glycidyl methacrylate-dimethylacrylamide block copolymers), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, and derivatives thereof.

[0047] There are no particular limitations on the material that can be used to form the antithrombosis coating layer 150, but bio-derived materials including heparin, urokinase, etc. can be used.

[0048] Next, a method for forming a lubricating coating layer will be described, in which the lubricating coating layer 140 is provided at a position other than the inner peripheral surface 130a of the side hole 130 of the cannula body 110. Note that the procedures and drawings described below are intended to provide an outline of the method for forming the lubricating coating layer, and some details will be omitted.

[0049] As shown in FIG. 6A, a cannula body 110 without a lubricious coating layer 140 formed thereon is prepared.

[0050] As shown in Figure 6B, core metal 600 is inserted into cannula body 110. Masking member 500 is placed so as to cover an area including side hole 130 and peripheral portion 130b of side hole 130. Masking member 500 is preferably a thin-film sealing member that is detachable from cannula body 110 and that can prevent liquid pooling at the boundary between masking member 500 and its surroundings.

[0051] 6C, lubricating coating material 140A is applied to cannula body 110 with masking member 500 placed on cannula body 110. At this time, masking member 500 prevents lubricating coating material 140A from being applied to side hole 130 and peripheral portion 130b of side hole 130.

[0052] As shown in FIG. 6D, masking member 500 is removed from cannula body 110.

[0053] Lubricating coating material 140A is cured after masking member 500 is removed from cannula body 110. By the above procedure, cannula body 110 can be manufactured in which lubricating coating layer 140 is not provided on inner circumferential surface 130a and peripheral portion 130b of side hole 130, as shown in FIG.

[0054] 7A is a cross-sectional view taken along the line 7A-7A in FIG. 6E. No side hole 130 is formed in the area indicated by arrow 7A-7A. Therefore, lubricious coating layer 140 is provided around the entire circumference of cannula body 110 in this area.

[0055] Figure 8 is a cross-sectional view taken perpendicular to the axis at the location indicated by arrows 8A-8A in Figure 6E. Two side holes 130 are formed at the location indicated by arrows 8A-8A so as to face each other across the axis c1 of cannula body 110. No lubricating coating layer 140 is provided on inner circumferential surface 130a and its surrounding area 130b of each side hole 130.

[0056] Next, methods for forming the lubricating coating layer according to Modifications 1 to 3 will be described.

[0057] As shown in FIG. 9A, in the method for forming a lubricious coating layer according to Modification 1, a cannula body 110 without a side hole 130 is prepared.

[0058] As shown in FIG. 9B, a lubricious coating material 140A is applied to cannula body 110.

[0059] As shown in FIG. 9C, the lubricating coating material 140A is cured.

[0060] 9D, side holes 130 are formed at predetermined positions in cannula body 110 provided with lubricious coating layer 140. By the above procedure, cannula body 110 can be manufactured in which inner circumferential surfaces 130a of side holes 130 are not provided with lubricious coating layer 140.

[0061] As shown in FIG. 10A, in the method for forming a lubricious coating layer according to the second modification, a cannula body 110 having a side hole 130 formed therein is prepared.

[0062] 10B, masking member 500 is placed so as to circumferentially cover (all or part of) the portion of cannula body 110 that includes side hole 130. With masking member 500 placed, lubricating coating material 140A is applied to cannula body 110.

[0063] Lubricating coating material 140A is cured after masking member 500 is removed from cannula body 110. By the above procedure, cannula body 110 can be manufactured in which lubricating coating layer 140 is not provided on inner circumferential surface 130a of side hole 130 and its surrounding area 130b, as shown in Figure 10C.

[0064] As shown in FIG. 11A, in the method for forming a lubricious coating layer according to Modification 3, a cannula body 110 having a side hole 130 formed therein is prepared.

[0065] 11B, masking member 500 is placed so as to linearly cover a predetermined axial range including side hole 130 of cannula body 110. With masking member 500 placed, lubricating coating material 140A is applied to cannula body 110.

[0066] Lubricating coating material 140A is cured after masking member 500 is removed from cannula body 110. By the above procedure, cannula body 110 can be manufactured in which lubricating coating layer 140 is not provided on inner circumferential surface 130a of side hole 130 and its surrounding area 130b, as shown in FIG.

[0067] The lubricating coating layer 140 formed by the method according to Variation 3 has a linear pattern along the axial direction of the cannula body 110 so as not to overlap with the multiple side holes 130 (see FIG. 13 ) located at opposing positions across the axis c1. As shown in FIGS. 11C , 12 , and 13 , the lubricating coating layer 140 occupies approximately the same area in the circumferential direction of the cannula body 110 at each axial portion of the cannula body 110. Therefore, the insertability of the cannula body 110 into a blood vessel is approximately the same in the region where the lubricating coating layer 140 is formed. This prevents variations in sliding resistance at each axial portion of the cannula body 110. This further effectively improves insertability into a blood vessel. The cannula body 110 may also be configured with an odd number of side holes 130 arranged circumferentially (e.g., three side holes 130 spaced 120° apart). In this configuration, for example, the lubricating coating layer 140 can be provided so as to extend linearly between the side holes 130 adjacent in the circumferential direction.

[0068] 14 shows a lubricating coating layer 140 according to Modification 4. In this example, the lubricating coating layer 140 extends in a spiral pattern based on the axis c1 so as not to overlap with the side holes 130 arranged at positions opposite each other across the axis c1. When the lubricating coating layer 140 is provided in this manner, as in Modification 3, the area occupied by the lubricating coating layer 140 in the circumferential direction of the cannula body 110 is substantially the same at each axial portion of the cannula body 110. This prevents variations in sliding resistance at each axial portion of the cannula body 110. This further effectively improves insertability into a blood vessel.

[0069] 15 shows a cannula body 110 provided with a lubricating coating layer 140 according to Modification 5. In this example, lubricating coating layer 140 is provided only in a predetermined range between distal end 111 of cannula body 110 and side hole 130 located most distally. Therefore, lubricating coating layer 140 is not provided on inner circumferential surface 130a of side hole 130 and its surrounding area 130b.

[0070] When forming lubricating coating layer 140 according to Variation 5, distal end 111 of cannula body 110 is dipped in lubricating coating material 140A, and then cannula body 110 is lifted up from lubricating coating material 140A. During this process, lubricating coating material 140A flows toward distal end 111 due to its own weight, forming a tapered portion of lubricating coating material 140A at the boundary between the proximal end of lubricating coating layer 140 and the non-coated region. This prevents a step from being formed at the boundary between the proximal end of lubricating coating layer 140 and the non-coated region.

[0071] Although the above-described method for forming the lubricating coating layer uses the masking member 500, the method is not limited to this. For example, it is also possible to use a high-precision application device (spray) to spray the lubricating coating material 140A onto the portions of the side hole 130 other than the inner circumferential surface 130a and the peripheral portion 130b.

[0072] Next, a preferred example of the arrangement, size, number, etc. of the side holes 130 will be described.

[0073] The percutaneous catheter (catheter for blood removal) of this embodiment is devised to enable blood removal from the distal end side of the cannula body while reducing pressure loss during blood removal.

[0074] For example, to enable blood removal through a side hole located closer to the proximal end while reducing pressure loss during blood removal, the side hole is located closer to the proximal end (a position that shortens the flow path). By locating the side hole closer to the proximal end, blood removal is primarily performed at the proximal end of the cannula body. When the cannula body is configured in this manner, the proximal end portion of the cannula body functions to actually perform blood removal relative to its entire length. While physicians and other surgeons determine the placement position of the cannula body using X-rays or ultrasound, the use of the above-described configuration makes it difficult to intuitively grasp from which part of the body blood will actually be removed after placement. Furthermore, in a central vein where a cannula body is placed, it is desirable to achieve balanced blood removal from the ascending vena cava and the descending vena cava. However, achieving such a balance is difficult if blood removal is performed only from the proximal end.

[0075] In consideration of the above-mentioned problems, the percutaneous catheter 100A can employ the following structure.

[0076] As shown in FIG. 16 , the cannula body 110 provided in the percutaneous catheter 100A has a tip region A1 provided in a predetermined range from the tip where the tip opening 112 is located toward the base end 113, an intermediate region A2 provided in a predetermined range from the base end of the tip region A1 toward the base end 113, and a base region A3 provided in a predetermined range from the base end of the intermediate region A2 toward the base end 113.

[0077] In cannula body 110, at least one side hole 130 is formed in each of distal region A1, intermediate region A2, and proximal region A3.

[0078] The distal region A1 and the intermediate region A2 have a greater number of side holes 130 and / or larger diameters of the side holes 130 than the proximal region A3. By providing the side holes 130 in this manner, the cannula body 110 equalizes the flow rate ratios in the distal region A1, the intermediate region A2, and the proximal region A3. In other words, it is possible to ensure a blood flow rate that takes pressure loss into consideration in the distal region A1 and the intermediate region A2 of the cannula body 110, thereby reducing variations in the flow rate ratio between the distal region A1 and the intermediate region A2 and the proximal region A3, where pressure loss is relatively small.

[0079] As shown in Figure 16, side holes 131 to 135 can be arranged in each of the regions A1, A2, and A3. The position, size, and distance (spacing) between each of the side holes 131 to 135 can be set appropriately depending on the desired flow rate ratio. For example, by adjusting the diameter, position, spacing, and circumferential number of side holes, it is possible to control the flow rate ratio in each of the regions A1, A2, and A3.

[0080] As described above, the lumen 120 of the cannula body 110 is configured to allow the dilator 200 to be inserted therein (see FIG. 3).

[0081] As shown in Fig. 17A, the inner diameter D1 of the tip portion 111 of the cannula body 110 can be formed smaller than the outer diameter D2 of the main body 210 of the dilator 200. With this configuration, as shown in Fig. 17B, when the dilator 200 is inserted into the lumen 120 of the cannula body 110, the dilator 200 expands the diameter of the tip portion 111 of the cannula body 110. This reduces the step (gap) formed between the dilator 200 and the edge 112a of the tip opening 112 of the cannula body 110. This reduces the insertion resistance when inserting the catheter assembly 10 into a blood vessel, further improving insertability.

[0082] The dilator 200 can be configured to have a step suppression portion 300 that suppresses the formation of a step (gap) between the edge portion 112a of the tip opening 112 of the cannula body 110 and the dilator 200 protruding from the tip opening 112 when the dilator 200 is inserted into the lumen 120.

[0083] As shown in Figure 18A, the step suppression portion 300 can be configured, for example, as a loop-shaped linear body disposed on the main body portion 210 of the dilator 200. As shown in the partial cross-sectional view of Figure 18B, the step suppression portion 300 is disposed so as to cover the edge portion 112a of the tip opening 112 when the main body portion 210 of the dilator 200 is inserted into the lumen 120 of the cannula body 110. Therefore, the step suppression portion 300 can prevent a step from being formed between the dilator 200 and the edge portion 112a of the tip opening 112 of the cannula body 110. When the dilator 200 is removed from the lumen 120 of the cannula body 110, the step suppression portion 300 deforms along the outer surface of the main body portion 210 of the dilator 200 as the dilator 200 moves in the axial direction, as shown by the two-dot chain line in Figure 18B. Therefore, the dilator 200 provided with the step suppression portion 300 can be smoothly removed from the lumen 120 of the cannula body 110.

[0084] The step suppression portion 300 can be formed of a plurality of linear bodies, for example, as shown in Fig. 19 . The step suppression portion 300 can also be formed of a plurality of linear bodies connected to form a mesh, for example, as shown in Fig. 20 . The step suppression portion 300 formed of these linear bodies deforms along the outer surface of the main body portion 210 of the dilator 200 when the dilator 200 is removed from the lumen 120 of the cannula body 110. Therefore, the dilator 200 provided with the step suppression portion 300 can be smoothly removed from the lumen 120 of the cannula body 110.

[0085] The step suppressing portion 300 is not particularly limited in its specific configuration, as long as it can suppress the formation of a step between the edge portion 112 a of the tip opening 112 and the dilator 200 .

[0086] 21, the step suppression section 300 can be formed in the main body section 210 of the dilator 200 and can be configured as a recessed section (concave section) capable of accommodating the tip of the cannula body 110. Alternatively, the step suppression section 300 can be formed in the main body section 210 of the dilator 200 and can be configured as a protruding section (convex section) capable of covering the tip of the cannula body 110 from the tip surface side, as shown in FIG.

[0087] 23A and 23B show a tray 400 configured for a percutaneous catheter. The percutaneous catheter 100 and tray 400 constitute a medical instrument set 700.

[0088] Tray 400 is configured to be able to hold liquid L for contacting lubricious coating layer 140 (see FIG. 5, etc.) of cannula body 110. Liquid L is, for example, physiological saline.

[0089] The tray 400 has a storage portion 410 that can accommodate the tip portion 111 of the cannula body 110 on which the lubricating coating layer 140 is disposed, an insertion portion 420 that allows the cannula body 110 to be inserted into the storage portion 410, and a fixing portion 430 that can fix the tip portion 111 of the cannula body 110.

[0090] 23A and 23B, when using the percutaneous catheter 100, the cannula body 110 is inserted into the container 410 of the tray 400 filled with the liquid L, thereby bringing the liquid L into contact with the lubricious coating layer 140. This allows the lubricious coating layer 140 to exhibit lubricity, and the percutaneous catheter 100 can be prepared for insertion into a blood vessel.

[0091] In addition, a seal member or the like can be appropriately placed in insertion section 420, which serves as the entrance and exit for cannula body 110, to prevent the liquid contained in storage section 410 from leaking out.

[0092] 24 , insertion portion 420 provided on tray 400 can be configured to have a tapered cross-sectional shape extending obliquely toward the bottom side of storage portion 410. When insertion portion 420 is configured with the above-described cross-sectional shape, cannula body 110 can be inserted into storage portion 410 easily and smoothly.

[0093] This application is based on Japanese Patent Application No. 2024-007427, filed on January 22, 2024, the disclosure of which is incorporated herein by reference in its entirety.

[0094] REFERENCE SIGNS LIST 10 Catheter assembly 100 Percutaneous catheter 110 Cannula body 111 Tip portion of cannula body 112 Tip opening 112a Edge portion of tip opening 120 Lumen 130 Side hole 131 Side hole 132 Side hole 133 Side hole 134 Side hole 135 Side hole 130a Inner peripheral surface of side hole 130b Peripheral edge portion 140 Lubricious coating layer 140A Lubricious coating material 150 Antithrombogenic coating layer 170 Connector portion 200 Dilator 210 Dilator main body portion 211 Tip portion of dilator 220 Hub portion 300 Step suppression portion 400 Tray 410 Storage portion 420 Insertion portion 430 Fixation portion 500 Masking member 700 Medical instrument set A1 Distal region A2 Intermediate region A3 Proximal region L Liquid

Claims

1. A percutaneous catheter comprising a cannula body extending in the axial direction, wherein the cannula body has a lumen through which blood can flow, a tip opening communicating with the lumen, at least one or more side holes formed at a predetermined position between the tip and the base end of the cannula body and communicating with the lumen, and a lubricating coat layer provided in a predetermined range from the tip side to the base end side of the cannula body, and the lubricating coat layer is not provided on the inner peripheral surface of the side hole. A percutaneous catheter characterized by this.

2. The percutaneous catheter according to claim 1, wherein the lubricating coat layer is not provided on the peripheral portion surrounding the side hole when the side hole is viewed in plan view.

3. The percutaneous catheter according to claim 2, wherein the lubricating coat layer is not provided near the edge on the outer peripheral side of the side hole and on the hole side wall of the side hole.

4. An antithrombotic coat layer is disposed on the peripheral portion, and the lubricating coat layer and the antithrombotic coat layer disposed so as to cover the lubricating coat layer are disposed at a position farther from the side hole than the peripheral portion. The percutaneous catheter according to claim 2 or claim 3, characterized by this.

5. The cannula body is further provided with a coat layer made of an antithrombotic coat material, and a mixed layer in which the lubricating coat layer and the antithrombotic coat material are mixed is formed at a position farther from the side hole than the peripheral portion. The percutaneous catheter according to claim 2 or claim 3, characterized by this.

6. A plurality of the side holes are provided so as to face each other across the axis of the cannula body, and the lubricating coat layer extends in a linear pattern along the axial direction of the cannula body so as not to overlap the plurality of side holes, or in a spiral pattern with respect to the axis so as not to overlap the plurality of side holes. The percutaneous catheter according to claim 1.

7. The cannula body has a tip region provided in a predetermined range from the tip where the tip opening is located toward the proximal end side, an intermediate region provided in a predetermined range from the proximal end of the tip region toward the proximal end side, and a proximal end region provided in a predetermined range from the proximal end of the intermediate region toward the proximal end side. At least one or more of the side holes are formed in each of the tip region, the intermediate region, and the proximal end region. In the tip region and the intermediate region, the number of the side holes is larger and / or the hole diameter of the side holes is larger than that in the proximal end region. The percutaneous catheter according to claim 1, characterized in that.

8. The lumen is configured to be capable of inserting a dilator. The dilator has a step suppressing portion that suppresses the formation of a step between an edge portion of the tip opening and the dilator protruding from the tip opening in a state where the dilator is inserted into the lumen. The percutaneous catheter according to claim 1.

9. A medical instrument set comprising the percutaneous catheter according to any one of claims 1 to 8, and a tray capable of holding a liquid for bringing the lubricating coat layer of the cannula body into contact with the liquid. The tray has a housing portion capable of housing a tip portion of the cannula body where the lubricating coat layer is disposed, an insertion portion allowing the insertion of the cannula body into the housing portion, and a fixing portion capable of fixing the tip portion of the cannula body. A medical instrument set.

Images