Medical tool set

Abstract

To provide a medical tool set that can improve safety and work efficiency.SOLUTION: A medical tool set includes: a first tube; a flexible container configured to be connected to the first tube and including a lumen filled with liquid and a discharge port; and a packaging bag incorporating the first tube and the flexible container.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a medical equipment set having a flexible container filled with a liquid, a tube, and a packaging bag containing these. [Background technology]

[0002] Conventionally, injection preparations in which a syringe is pre-filled with a heparin solution or the like, so-called prefilled syringe preparations, have been used in medical settings. Such prefilled heparin syringe preparations are used in a procedure to prevent blood from coagulating and blocking a catheter, so-called heparin lock. For example, Patent Document 1 discloses a heparin-containing prefilled syringe preparation obtained by filling a syringe with a heparin solution containing about 160 to 1000 units / mL of heparin and subjecting the syringe to autoclaving.

[0003] Embolization, which involves placing an in-vivo device such as a coil within an aneurysm to promote thrombosis and prevent the aneurysm from rupturing, is also known. Patent Document 2, for example, discloses an embolization device having a delivery catheter with a proximal portion, a distal portion, an intermediate portion formed from a relatively flexible polymeric material, a first lumen, a second lumen with a side opening, and a puller wire, the side opening being located at a predetermined position within the intermediate portion of the delivery catheter. The puller wire extends within the first lumen and is fixedly attached to the delivery catheter at a position adjacent to the distal portion of the delivery catheter. Pulling the puller wire toward the proximal portion causes the relatively flexible intermediate portion to bend, thereby moving the side opening laterally relative to the delivery catheter. Patent Document 2 also discloses that an embolic coil can be delivered into an aneurysm via the catheter by applying hydraulic pressure in a syringe. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2006-169214 [Patent Document 2] Japanese Patent Application Laid-Open No. 2003-102842 Summary of the Invention [Problem to be solved by the invention]

[0005] Tubes such as catheters and syringes are used in a variety of procedures. For example, in medical settings, filling a syringe with liquid and then connecting the syringe to a tube is time-consuming and can introduce bacteria or dust during the process. Furthermore, discharging the filled liquid from the syringe requires holding the syringe barrel while pressing the plunger, which requires the use of both hands. The present invention has been made in light of the above circumstances, and its purpose is to provide a medical device set that can improve safety and work efficiency. [Means for solving the problem]

[0006] The medical device set according to the embodiment that can solve the above problems is as follows. [1] A first tube; a flexible container configured to connect to the first tube and having a lumen filled with a liquid and a discharge port; A medical device set comprising the first tube and a packaging bag containing the flexible container.

[0007] By pre-filling the flexible container with liquid as described above, the work of filling the flexible container with liquid can be omitted, for example, in medical settings. By eliminating this work, contamination during the filling process (hereinafter referred to as "contamination") can be avoided. Furthermore, because the flexible container is flexible, liquid can be discharged from the discharge port by a simple operation such as compressing the container with a finger. In this way, the medical device set can improve safety and work efficiency.

[0008] The medical device set according to the embodiment is preferably any one of the following [2] to

[17] . [2] The medical device set according to [1], wherein the flexible container has a flexible blow-molded portion, and the blow-molded portion has at least a part of the inner cavity. [3] The medical device set according to [1] or [2], wherein the flexible container has a flexible bag-like portion, and the bag-like portion has at least a part of the inner cavity. [4] The medical device set according to any one of [1] to [3], further comprising a clip that holds a part of the flexible container. [5] The medical device set according to any one of [1] to [4], wherein the flexible container is directly or indirectly connected to the first tube. [6] The medical device set according to [5], wherein the inner cavity of the flexible container, the inner cavity of the first tube, and the space within the packaging bag are in communication with each other. [7] The medical device set according to any one of [1] to [6], further comprising a connecting member that connects the flexible container and the first tube and has an inner cavity that communicates with the inner cavity of the flexible container and the inner cavity of the first tube. [8] The medical device set according to any one of [1] to [7], wherein the liquid includes physiological saline. [9] The medical device set according to any one of [1] to [8], wherein the liquid contains a drug.

[10] The medical device set according to [9], wherein the drug includes an anticoagulant, an antiplatelet drug, an anticancer drug, or a mixture thereof.

[11] The medical device set according to any one of [1] to

[10] , further comprising an in-vivo indwelling device at least a portion of which is disposed in the lumen of the first tube, and a long in-vivo indwelling device delivery device having the in-vivo indwelling device disposed at its distal end.

[12] The medical device set according to

[11] , wherein the in-vivo indwelling device is detachably connected to the distal end of the in-vivo indwelling device delivery device.

[13] The medical device set according to

[11] or

[12] , wherein the in-vivo indwelling device has a coil portion.

[14] The medical device set according to any one of [1] to

[13] , further comprising a second tube, in which at least a portion of the first tube is disposed in the lumen of the second tube.

[15] The medical device set according to

[14] , wherein the second tube is wound.

[16] The medical device set according to

[14] or

[15] , wherein a portion of the first tube is exposed from one longitudinal end of the second tube, and a portion of the in-vivo indwelling device delivery device is exposed from the other longitudinal end of the second tube.

[17] The medical device set according to any one of [1] to

[16] , wherein the liquid is not present in the lumen of the first tube. [Effects of the Invention]

[0009] According to the present invention, a medical equipment set that can improve safety and work efficiency can be provided. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a plan view of a medical equipment set according to a first embodiment. [Figure 2] FIG. 2 is a plan view of FIG. 1 in which the packaging bag, the second tube, and the tube clip are omitted. [Figure 3] FIG. 3 is an enlarged view of the vicinity of the connecting member in FIG. [Figure 4] FIG. 4 is a plan view of the flexible container of FIG. 3 when the flexible container is crushed with fingers. [Figure 5] FIG. 5 is a perspective view of a modified example of the flexible container of the medical instrument set according to the first embodiment. [Figure 6] FIG. 6 is a perspective view of the flexible container of FIG. 5 when it is crushed with fingers. [Figure 7] 7 is a side view of the vicinity of the tip of the first tube in FIG. 2. FIG. [Figure 8] 8 is a side view of the in-vivo indwelling device connected to the in-vivo indwelling device delivery device exposed from the tip of the first tube in FIG. 2. FIG. [Figure 9] FIG. 9 is an enlarged view of the vicinity of the connecting member when the flexible container and the connecting member in FIG. 2 are connected by a filter. [Figure 10] FIG. 10 is an enlarged view of the vicinity of the connecting member when a part of the flexible container of FIG. 2 is clipped by a clip. [Figure 11] FIG. 11 is a plan view of the medical equipment set according to the second embodiment. [Figure 12] FIG. 12 is a plan view of the medical equipment set according to the third embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, component reference numerals may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0012] A medical device set according to an embodiment includes a first tube, a flexible container configured to connect to the first tube and having a lumen filled with liquid and a discharge outlet, and a packaging bag containing the first tube and the flexible container. Since the flexible container is pre-filled with liquid as described above, the task of filling the flexible container with liquid can be omitted, for example, in a medical setting. Eliminating this task can prevent contamination during the filling process. Furthermore, because the flexible container is flexible, liquid can be discharged from the discharge outlet by a simple operation, such as compressing the container with fingers. In this way, the medical device set can improve safety and work efficiency. As described below, the flexible container may be configured to connect directly or indirectly to the first tube, and the flexible container and the first tube may be arranged separately within the packaging bag.

[0013] A medical device set according to a first embodiment will be described below with reference to FIGS. 1 to 10. FIG. 1 is a plan view of the medical device set according to the first embodiment. FIG. 2 is a plan view of FIG. 1 with the packaging bag, second tube, and tube clip omitted. FIG. 3 is an enlarged view of the vicinity of the connecting member in FIG. 2, and FIG. 4 is a plan view of the flexible container of FIG. 3 when crushed with fingers. FIG. 5 is a perspective view of a modified flexible container of the medical device set according to the first embodiment, and FIG. 6 is a perspective view of the flexible container of FIG. 5 when crushed with fingers. FIG. 7 is a side view of the vicinity of the tip of the first tube in FIG. 2, and FIG. 8 is a side view of the distal end of the first tube in FIG. 2 when the in-vivo indwelling device connected to the in-vivo indwelling device delivery device is exposed from the distal end of the first tube in FIG. 2. FIG. 9 is an enlarged view of the vicinity of the connecting member when the flexible container and connecting member of FIG. 2 are connected with a filter. FIG. 10 is an enlarged view of the vicinity of the connecting member when a part of the flexible container of FIG. 2 is clipped by a clip.

[0014] As shown in Fig. 1, a medical device set 91 according to the first embodiment includes a first tube 1, a flexible container 8, and a packaging bag 5 containing the first tube 1 and the flexible container 8. The flexible container 8 is connected to the first tube 1. This connection is preferably detachable. Although Fig. 1 shows a configuration in which the flexible container 8 is indirectly connected to the first tube 1 via a connecting member 6, it may also be connected directly without the connecting member 6.

[0015] As shown in FIG. 3, the flexible container 8 has a lumen 8C filled with liquid 8F and a discharge port 8L. Because the flexible container 8 is flexible, it can be compressed by applying pressure, for example, with a finger, as shown in FIG. 4. The arrows in FIG. 4 indicate the direction of pressure. By compressing the flexible container 8 in this manner, the liquid 8F in the lumen 8C can be discharged from the discharge port 8L, and the liquid 8F can be supplied to the first tube 1. Ultimately, the liquid 8F can be discharged from the tip 1B of the first tube 1 shown in FIGS. 2 and 7, which allows for tasks such as air removal. Furthermore, the compressed flexible container 8 has a reduced volume, making it easier to dispose of. It is preferable that the flexible container 8 have flexibility comparable to that of commercially available enema containers.

[0016] As shown in FIG. 3, it is preferable that the outer surface of the flexible container 8 has a curved portion. In this case, it is preferable that the flexible container 8 has a spherical recess. This makes it easier to apply pressure to the flexible container 8 from various directions, making it easier to compress with, for example, the thumb and index finger. It is also possible to apply pressure by holding the flexible container 8 in one hand. It is also preferable that the flexible container 8 has a shape in which a portion of an ellipsoid is missing. Hereinafter, the portion in which a portion of an ellipsoid is missing may be referred to as an ellipsoid recess.

[0017] As shown in FIG. 5, the outer surface of the flexible container 8 may have multiple flat portions. In this case, it is preferable that the flexible container 8 has a concave polyhedron portion. For example, by pinching and pressing the concave portion of the concave polyhedron portion in the direction of the arrow in FIG. 5 with your fingers, the flexible container 8 can be compressed as shown in FIG. 6. Such compression can be performed with one hand. The concave polyhedron portion may include multiple flat portions, and for example, the portion where the multiple flat portions are connected may be curved. Furthermore, although not shown, the flexible container 8 may have a bellows-shaped portion. Furthermore, the flexible container 8 may include a concave polyhedron portion, a convex polyhedron portion, a spherical portion, an ellipsoidal spherical portion, a cylindrical portion, or a combination thereof.

[0018] As shown in Figures 3 and 5, the flexible container 8 preferably has a flexible blow-molded portion 8M. The blow-molded portion 8M preferably has at least a portion of the lumen 8C. The flexible blow-molded portion 8M formed by blow molding has a thin film thickness and is easily deformed, making it easy to compress with your fingers. If at least a portion of the lumen 8C is located inside such an easily compressible portion, it becomes easier to dispense the liquid 8F. Forming the flexible container 8 by blow molding can reduce manufacturing costs. Note that blow molding also includes blow molding in a molding-filling process.

[0019] As shown in Figures 3 and 5, the flexible container 8 preferably has a flexible bag-shaped portion 8N. The bag-shaped portion 8N preferably has at least a portion of the lumen 8C. The bag-shaped portion 8N has a thin membrane thickness and is therefore easily compressed with the fingers. When at least a portion of the lumen 8C is located inside such an easily compressible portion, it becomes easier to dispense the liquid 8F.

[0020] The film thickness of the blow molded portion 8M or the bag-shaped portion 8N is preferably 0.1 to 5.0 mm, more preferably 0.2 to 1.5 mm, and even more preferably 0.3 to 1.0 mm, which makes it easier to exhibit flexibility while maintaining a strength sufficient to store the liquid 8F.

[0021] As shown in Figures 3 and 5, it is preferable that the flexible container 8 has a straight tubular portion 8T. This makes it easier to connect the flexible container 8 to other members. As shown in Figures 3 and 5, it is preferable that the straight tubular portion 8T is located closer to the tip than the blow-molded portion 8M. It is also preferable that the straight tubular portion 8T and the blow-molded portion 8M are adjacent to each other. It is preferable that the straight tubular portion 8T is located closer to the tip than the bag-shaped portion 8N. It is also preferable that the straight tubular portion 8T and the bag-shaped portion 8N are adjacent to each other.

[0022] As shown in FIGS. 1 and 2, the lumen 8C of the flexible container 8, the lumen 1C of the first tube 1, and the space 5C within the packaging bag 5 are preferably in communication with each other. This communication configuration allows expanded gas within the lumen 1C of the first tube 1 to move from the distal end 1B of the first tube 1, as shown in FIGS. 2 and 7, to the space 5C within the packaging bag 5 when the temperature around the medical equipment set 91 rises. As a result, pressure due to gas expansion is less likely to be applied between the distal end 8b of the flexible container 8 and the first tube 1, making the connection less likely to loosen. Examples of high-temperature environments include high-temperature environments during heat sterilization, such as ethylene oxide gas sterilization, and high-temperature environments during transportation and storage. This communication configuration also allows the flexible container 8 to be removed from the packaging bag 5 and compressed at the time of use to supply the liquid 8F to the first tube 1, facilitating tasks such as air removal. Furthermore, since the first tube 1 is connected to the tip 8b of the flexible container 8 in advance, the work of connecting the first tube 1 to the tip 8b of the flexible container 8 in the medical field can be omitted, thereby improving work efficiency.

[0023] As shown in FIG. 3, the medical equipment set 91 preferably includes a connecting member 6 connecting the flexible container 8 and the first tube 1. The connecting member 6 preferably has a lumen 6C that communicates with the lumen 8C of the flexible container 8 and the lumen 1C of the first tube 1. This allows liquid 8F to be supplied from the flexible container 8 to the first tube 1 via the connecting member 6. In this case, the lumen 8C of the flexible container 8, the lumen 6C of the connecting member 6, the lumen 1C of the first tube 1, and the space 5C within the packaging bag 5 are also communicated with each other, so that gas within the lumen 6C of the connecting member 6 and the lumen 1C of the first tube 1 can migrate to the space 5C within the packaging bag 5 in a high-temperature environment. As described above, the first tube 1 is preferably indirectly connected to the distal end 8b of the flexible container 8, but may also be directly connected to the distal end 8b of the flexible container 8. In the case of direct connection, for example, the base end 1a of the first tube 1 may be positioned within the tip end 8b of the flexible container 8, or the tip end 8b of the flexible container 8 may be positioned within the base end 1a of the first tube 1.

[0024] The connecting member 6 preferably has multiple openings, each of which communicates with the lumen 6C of the connecting member 6. Specifically, as shown in FIG. 3, the connecting member 6 preferably has an opening to which the base end 1a of the first tube 1 is connected and an opening to which the distal end 8b of the flexible container 8 is connected. This allows the above-mentioned communication configuration to be formed. The connecting member 6 preferably also has an opening through which the in-vivo indwelling device delivery device 4 (described later) passes. This allows a portion of the in-vivo indwelling device delivery device 4 to be positioned within the first tube 1. Furthermore, as shown in FIG. 9 (described later), the connecting member 6 may have an opening to which a filter 6F is connected instead of the distal end 8b of the flexible container 8. As shown in FIG. 3, the connecting member 6 preferably has a branched structure. This makes it easier to avoid contact between the flexible container 8 and other components.

[0025] 3, the connecting member 6 preferably has a fitting portion 6G that fits into the flexible container 8. The fitting portion 6G of the connecting member 6 is preferably cylindrical. The tip portion 8b of the flexible container 8 may be disposed outside the fitting portion 6G of the connecting member 6, or may be disposed inside the fitting portion 6G.

[0026] As shown in Fig. 3, the tip portion 8b of the flexible container 8 is preferably cylindrical. The inner or outer surface of the tip portion 8b may have a spiral groove or a spiral protrusion. Furthermore, the fitting portion 6G of the connecting member 6 may have a shape on the outer or inner surface that can fit into the spiral groove or spiral protrusion.

[0027] As shown in FIG. 3 , the proximal end 1a of the first tube 1 is preferably fixed to the opening of the connecting member 6. Alternatively, the proximal end of the first tube 1 may be positioned within the lumen 6C of the connecting member 6, with a portion of the proximal end 1a of the first tube 1 distal to the proximal end being fixed to the opening of the connecting member 6. Examples of such fixing methods include adhesive, welding, fitting, or a combination of these. The proximal end 1a of the first tube 1 may have a tapered portion whose outer diameter decreases from the proximal end to the distal end. By fixing the connecting member 6 so that this tapered portion is located within the connecting member 6, the proximal end 1a of the first tube 1 is more unlikely to come off the connecting member 6.

[0028] The connecting member 6 preferably contains acrylic resin, polyester resin, polycarbonate resin, polyvinyl chloride resin, or a combination thereof. The polyester resin preferably contains polyethylene terephthalate. This improves transparency, making it easier to check the state inside the connecting member 6.

[0029] As shown in FIG. 1 , the flexible container 8 has a lumen 8C, which is filled with a liquid 8F. This eliminates the need to fill the flexible container 8 with liquid after removing the flexible container 8 connected to the first tube 1 from the packaging bag 5, thereby reducing the workload in, for example, a medical setting. Furthermore, it is possible to prevent bacteria and dust from being mixed in when filling the flexible container 8 with liquid in a medical setting. The liquid surface of the liquid 8F is preferably located within the tip 8b of the flexible container 8, but may be located within the connecting member 6 or the first tube 1. The lumen 8C of the flexible container 8 preferably does not contain gas, but may contain gas. Examples of gas include air and sterilizing gas.

[0030] The liquid 8F preferably contains physiological saline. Physiological saline is suitable for use because it is less harmful to the living body. For example, physiological saline can be supplied from the flexible container 8 to the first tube 1 to remove gas from the first tube 1. The sodium chloride content of the physiological saline is preferably 0.5 to 2.0 w / v%, more preferably 0.6 to 1.5 w / v%, even more preferably 0.8 to 1.0 w / v%, and most preferably 0.9 w / v%. That is, physiological saline is most preferably a saline solution. This allows, for example, flushing operations to be performed. A 0.9 w / v% physiological saline solution can be prepared, for example, by dissolving 0.900 g of sodium chloride in purified water to make 100 mL.

[0031] Preferably, the liquid 8F contains a drug, such as an anticoagulant, an antiplatelet drug, or a mixture thereof, which helps prevent the development of blood clots and clogged catheters.

[0032] The anticoagulant preferably includes heparin, low molecular weight heparin, direct thrombin inhibitor, vitamin K-dependent coagulation factor synthesis inhibitor, edetate potassium salt, edetate sodium salt, sodium citrate, or a mixture thereof. The antiplatelet agent preferably includes an ADP receptor inhibitor, a 5-HT2 receptor inhibitor, a PDE inhibitor, a COX inhibitor, a prostaglandin preparation, or a mixture thereof.

[0033] The liquid 8F preferably contains physiological saline and a drug. For example, by containing physiological saline and heparin, the liquid 8F can be suitably used for flushing. It is particularly preferable that the liquid 8F contains physiological saline and heparin.

[0034] It is preferable that the liquid 8F is not present in the lumen 1C of the first tube 1. More specifically, it is preferable that the liquid 8F is not present in the lumen 1C of the first tube 1 inside the packaging bag 5. This makes it easier to prevent the liquid 8F from leaking into the space 5 inside the packaging bag 5. Furthermore, as will be described later, if the medical device set 91 has an in-vivo indwelling device 3 and the in-vivo indwelling device 3 is made of a material that swells with water, swelling of the material before treatment can be prevented by not having the liquid 8F present in the lumen 1C of the first tube 1. Furthermore, it is preferable that the liquid 8F is not present in the lumen 6C of the connecting member 6. This makes it easier to prevent the liquid 8F from leaking from the connecting member 6.

[0035] 9, the medical equipment set 91 may further include a filter 6F connected to the tip 8b of the flexible container 8 and the connecting member 6. Since the flexible container 8 and the first tube 1 are placed inside the packaging bag 5, they can basically maintain a sterile state after sterilization. However, even if the sterilization is insufficient and a small amount of bacteria remains in the liquid 8F, by connecting the filter 6F to the tip 8b of the flexible container 8, the filtered and sterilized liquid 8F can be supplied to the first tube 1.

[0036] The filter 6F preferably has a membrane and a housing incorporating the membrane. For example, the filter 6F is preferably a syringe filter. As shown in FIG. 9, the base end of the housing of the filter 6F is preferably connected to the tip 8b of the flexible container 8. The base end of the housing may be located inside or outside the tip 8b of the syringe 8. The tip end of the housing is preferably connected to the connecting member 6. The tip end of the housing may be located inside or outside the connecting member 6. The pore size of the membrane is preferably 0.10 to 0.50 μm, more preferably 0.15 to 0.45 μm, and even more preferably 0.20 to 0.25 μm. The base end and / or tip end of the housing of the filter 6F may have a threaded portion or a structure that can be fitted with a threaded portion.

[0037] The flexible container 8 preferably contains polyethylene, polypropylene, polymethylbutene, polymethylpentene, polyamide, vinyl chloride, polyethylene-polyvinyl acetate copolymer, styrene-based elastomer, polyolefin rubber, styrene-butadiene rubber, styrene-butadiene-styrene block copolymer, isoprene rubber, styrene-isoprene rubber, isobutylene rubber, or a combination thereof, more preferably contains low-density polyethylene, polyamide, polyethylene-polyvinyl acetate copolymer, or a combination thereof, and even more preferably contains low-density polyethylene. Low-density polyethylene has a density of 0.910 (g / cm 3 ) or more, 0.930 (g / cm 3 ) or less. Polyethylene is particularly preferred because it is easy to mold. The flexible container 8 may also contain an ultraviolet scattering agent such as titanium dioxide, a coloring agent, etc. to block light.

[0038] If the flexible container 8 contains, for example, rubber or elastomer and has rubber elasticity, it may be filled with the liquid 8F in an expanded state. In such a case, the flexible container 8 contracts, causing the liquid 8F to be expelled. Therefore, the medical tool set 91 preferably includes a member that prevents such expulsion. For example, as shown in FIG. 10 , the medical tool set 91 preferably includes a clip 9C that clamps a portion of the flexible container 8. By clamping a portion of the flexible container 8 with the clip 9C to block the passage of the liquid 8F, it is possible to prevent the liquid 8F from being expelled from the flexible container 8 before use. The clip 9C preferably clamps at least a portion of the portion 8Bp near the distal end 8B and the portion 8Ap near the proximal end 8A of the flexible container 8, the portion 8Bp being the portion near the distal end 8B. Furthermore, if the flexible container 8 has a straight tubular portion 8T, the clip 9C preferably clamps at least a portion of the straight tubular portion 8T. The medical tool set 91 may include the clip 9C even if the flexible container 8 does not have rubber elasticity.

[0039] As shown in FIG. 7, the medical instrument set 91 preferably further includes an in-vivo indwelling device 3, at least a portion of which is disposed in the lumen 1C of the first tube 1. Examples of the in-vivo indwelling device 3 include a coil, a stent, and a stent graft. Vascular lesions can be treated by delivering the in-vivo indwelling device 3 to the lesion via the first tube 1. The in-vivo indwelling device 3 may also be delivered to the lesion via a tube other than the first tube 1. The in-vivo indwelling device 3 is preferably located in an area 1 mm or more and 10 cm or less away from the tip 1B of the first tube 1, and more preferably in an area 2 mm or more and 5 cm or less away. This makes it easier for the first tube 1 to protect the in-vivo indwelling device 3 and makes it easier for the first tube 1 to be exposed from the tip 1B during use.

[0040] As shown in Figure 8, the in-vivo indwelling device 3 preferably has a coil portion 3E. By placing the coil portion 3E in a lesion such as an aneurysm, it is possible to prevent the vascular lesion from worsening. For example, by placing the coil portion 3E inside a cerebral aneurysm, it is possible to occlude the cerebral aneurysm and reduce the risk of rupture of the cerebral aneurysm.

[0041] Coil portion 3E of in-vivo indwelling device 3 is preferably connected to another member such as long in-vivo indwelling device delivery device 4, but does not have to be connected to another member. When it is not connected to another member, for example, water pressure can be applied to in-vivo indwelling device 3 placed in first tube 1 to eject in-vivo indwelling device 3 from tip 1B of first tube 1, thereby placing in-vivo indwelling device 3 at the lesion.

[0042] As shown in FIG. 7, the coil portion 3E preferably has a helical primary shape. Furthermore, as shown in FIG. 8, it is more preferable that the coil portion 3E has a secondary shape in which the helical primary shape is further formed into a helical or three-dimensional shape. Specifically, it is preferable that the coil portion 3E has a secondary shape when exposed from the first tube 1. This makes it easier to occlude the aneurysm. It is preferable that the coil portion 3E has one or more wires. It is preferable that one or more wires have the above-mentioned helical primary shape or secondary shape. Furthermore, the coil portion 3E may have fibers to promote thrombosis within the aneurysm.

[0043] The outer diameter of the coil portion 3E may be, for example, 150 μm or more, 180 μm or more, or 200 μm or more, or 400 μm or less, 380 μm or less, or 350 μm or less. In the case where the coil portion 3E has a secondary shape as shown in FIG. 8, the outer diameter is the outer diameter of the coil when the secondary shape of the coil portion 3E is linear as shown in FIG.

[0044] The wire of the coil section 3E is preferably biocompatible and flexible. The wire preferably contains platinum, gold, titanium, tungsten, tantalum, iridium, palladium, alloys thereof, stainless steel, or a combination thereof, and more preferably contains a platinum-tungsten alloy. The wire of the coil section 3E may contain a radiopaque material. The cross-sectional shape of the wire in a direction perpendicular to the longitudinal direction of the coil section 3E may be circular, elliptical, polygonal, or a combination thereof. The elliptical shape includes an oval shape and an oval shape. The polygonal shape includes a polygon with rounded corners. The outer diameter of the wire may be, for example, 25 μm or more, 30 μm or more, or 35 μm or more, or 125 μm or less, 100 μm or less, 75 μm or less, or 70 μm or less.

[0045] The coil portion 3E preferably contains a hydrophilic resin. By containing a hydrophilic resin, the coil portion 3E is more likely to swell when water is supplied to the coil portion 3E, making it easier to fill the space within the aneurysm with the coil portion 3E. The hydrophilic resin preferably contains polyvinyl alcohol. The polyvinyl alcohol may contain a polyvinyl alcohol cross-linked polymer, a polyvinyl alcohol water-absorbing gel freeze-thaw elastomer, an ethylene-vinyl alcohol copolymer, or a combination thereof. A drug may also be attached to the surface of the coil portion 3E.

[0046] The coil portion 3E preferably has a head portion 3H at its tip. The head portion 3H covers a portion of the wire to prevent the tip of the wire from directly contacting the inner wall of the blood vessel. The shape of the head portion 3H is preferably hemispherical, semi-elliptical, or cylindrical. The head portion 3H may be fixed to the outer surface, inner surface, or both of these surfaces of the coil portion 3E. The head portion 3H preferably contains metal or resin.

[0047] As shown in Figures 7 and 8, the medical device set 91 preferably includes a long in-vivo device delivery device 4 with an in-vivo device 3 disposed at its distal end. The distal end of the in-vivo device delivery device 4 refers to the distal end portion when the in-vivo device delivery device 4 is longitudinally divided into a distal end portion and a proximal end portion. Specifically, the in-vivo device 3 is preferably detachably connected to the distal end portion 4b of the in-vivo device delivery device 4. For example, by deforming the distal end portion 4b of the in-vivo device delivery device 4 within the lesion, the in-vivo device 3 can be detached from the in-vivo device delivery device 4 and placed in the lesion. The distal end portion 4b of the in-vivo device delivery device 4 can be deformed by, for example, fusing, electrolysis, mechanical disengagement, or a combination thereof. Fusing and electrolysis can be performed by, for example, fusing or electrolysis of the distal end portion 4b of the in-vivo device delivery device 4 using electricity or heat. For example, the proximal end of the in-vivo indwelling device delivery device 4 can be connected to a high-frequency power supply, and Joule heat can be generated near the tip 4b to melt the tip 4b. An example of mechanical release of the engagement is release of the engagement between the in-vivo indwelling device 3 and the in-vivo indwelling device delivery device 4, which is engaged by a hook and loop or the like. The in-vivo indwelling device 3 may be releasably connected to a part of the tip side of the in-vivo indwelling device delivery device 4 other than the tip 4b.

[0048] The tip 4b of the in-vivo indwelling device delivery device 4 preferably contains a thermoplastic resin. The thermoplastic resin preferably contains polyvinyl alcohol, polyethylene, polypropylene, polyvinyl chloride, polyvinyl acetate, polystyrene, polyurethane resin, ABS resin, acrylic resin, or a combination thereof, and preferably contains polyvinyl alcohol. These are preferred because they are prone to melting when heated and electrolysis when current is applied. The shape of the tip 4b of the in-vivo indwelling device delivery device 4 is preferably cylindrical, rod-like, or a combination thereof.

[0049] As shown in Figures 7 and 8, the in-vivo indwelling device 3 can be moved toward the distal end by the long in-vivo indwelling device delivery device 4. The in-vivo indwelling device delivery device 4 may be a solid, long body, a tube, or a combination of these. For example, the solid, long body is preferably a metal wire. Metal wires are more likely to exhibit conductivity. The metal wire preferably contains titanium, nickel-titanium alloy, cobalt-chromium alloy, tungsten alloy, stainless steel, or a combination of these, and more preferably contains stainless steel. Furthermore, the solid, long body may be covered with a resin tube. This makes it easier to prevent electrical leakage. The in-vivo indwelling device delivery device 4 may also have multiple solid, long bodies.

[0050] The in-vivo indwelling device delivery device 4 may contain an X-ray opaque material. A protective layer may be provided on the outer surface of the in-vivo indwelling device delivery device 4. The protective layer may contain a fluorine-based resin such as polytetrafluoroethylene (PTFE). The protective layer improves the sliding properties between the in-vivo indwelling device delivery device 4 and the first tube 1, etc.

[0051] The above has mainly been described in terms of the case where the in-vivo indwelling device 3 is a coil, but in the case where the in-vivo indwelling device 3 is a stent, the stent may be detachably connected to the distal end of the in-vivo indwelling device delivery device 4, just as in the case of a coil.

[0052] The longitudinal length of the first tube 1 is preferably longer than the shortest distance from the base end to the tip end of the flexible container 8. This makes it easier to insert the first tube 1 into the body. The longitudinal length of the first tube 1 is preferably 10 to 100 cm, and more preferably 20 to 60 cm.

[0053] 1, the medical instrument set 91 preferably further includes a second tube 2. It is preferable that at least a portion of the first tube 1 is disposed in the lumen 2C of the second tube 2. The second tube 2 can protect the first tube 1 from external pressure.

[0054] As shown in Figure 1, the second tube 2 is preferably wound. This allows the size of the packaging bag 5 to be reduced. Furthermore, this allows at least a portion of the first tube 1 disposed within the second tube 2 to be wound, as shown in Figure 2. When the arrangement shown in Figure 1 is achieved, for example, a portion of the first tube 1 may be inserted into the second tube 2 from one longitudinal end 2A of the second tube 2. Furthermore, a portion of the in-vivo indwelling device delivery device 4 may be inserted into the second tube 2 from the other longitudinal end 2B of the second tube 2.

[0055] 1, it is preferable that a portion of the first tube 1 is exposed from one longitudinal end 2A of the second tube 2. This configuration makes it easier to pull out the first tube 1 from one end 2A of the second tube 2 during use.

[0056] As shown in Figure 1, it is preferable that a portion of the in-vivo device delivery device 4 is exposed from the other longitudinal end 2B of the second tube 2. This configuration makes it easier to pull out the in-vivo device delivery device 4 from the other end 2B of the second tube 2 during use. During use, the in-vivo device 3 can be exposed from the tip 1B of the first tube 1 by pushing the in-vivo device delivery device 4 in a direction 4C from the base end to the tip of the in-vivo device delivery device 4 as shown in Figure 2.

[0057] The shape of the outer edge of the radial cross section of the first tube 1 and the second tube 2 is preferably a circle, an ellipse, a polygon, a rounded polygon, or a combination of these, with a circle, an ellipse, or a rounded polygon being more preferred, and a circle being even more preferred.

[0058] The first tube 1 is preferably biocompatible. The first tube 1 preferably contains a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a polyvinyl chloride resin, a silicone resin, natural rubber, or a combination thereof. These resins may contain an elastomer having rubber elasticity.

[0059] The second tube 2 preferably contains a polyolefin resin such as polyamide resin, polyethylene resin, polypropylene resin, ethylene-propylene copolymer, or ethylene-vinyl acetate copolymer, polyvinyl chloride resin, polystyrene resin, or polyimide resin, or a mixture thereof. The second tube 2 preferably has a higher Shore D hardness than the first tube 1. This allows the second tube 2 to more easily protect the first tube 1. The second tube 2 preferably contains a resin with a higher Shore D hardness than the resin contained in the first tube 1. This allows the second tube 2 to more easily protect the first tube 1. The Shore hardness can be measured, for example, according to ISO 868:2003, a plastics durometer hardness test method, using a type D durometer.

[0060] 1, the second tube 2 is preferably fixed in its wound shape by a plurality of tube clips 7. The tube clips 7 preferably have a plurality of grooves or through holes into which the second tube 2 can be fitted.

[0061] As shown in FIG. 1, the packaging bag 5 contains the flexible container 8, the first tube 1, etc. The packaging bag 5 preferably has a lower sheet and an upper sheet. The outer edge 5E of the packaging bag 5 preferably has a joint where the lower sheet and the upper sheet are joined to each other. This makes it easier to maintain the sterility of the flexible container 8, the first tube 1, etc. The packaging bag 5 may also have an intermediate sheet between the lower sheet and the upper sheet at the outer edge 5E, and the intermediate sheet may form a gusset of the packaging bag 5. The packaging bag 5 may also be formed by folding back a single sheet and joining the outer edges of the overlapping portion. These outer edges are preferably joined by heat sealing.

[0062] The upper sheet preferably includes a resin film, and more preferably consists of a resin film, which preferably includes a polyethylene layer, a polypropylene layer, an ethylene-vinyl acetate layer, a polyethylene terephthalate layer, a polyamide layer, a vinyl chloride layer, a polyurethane layer, a polystyrene layer, or a laminate thereof, and more preferably includes a polyethylene layer, a polypropylene layer, an ethylene-vinyl acetate layer, a polyethylene terephthalate layer, or a laminate thereof.

[0063] The lower sheet preferably includes a nonwoven fabric, a paper layer, or a laminate thereof, more preferably includes a nonwoven fabric or a paper layer, and even more preferably consists of a nonwoven fabric or a paper layer. This allows the lower sheet to exhibit breathability, facilitating ethylene oxide gas sterilization. Furthermore, the breathability of the packaging bag 5 allows expanded gas within the packaging bag 5 to migrate to the outside in a high-temperature environment. The nonwoven fabric preferably includes polyethylene, polypropylene, polyester, or a mixture thereof. The paper layer preferably includes uncoated paper, Japanese paper, or a laminate thereof. The nonwoven fabric and / or paper layer may be laminated with a perforated resin film.

[0064] The medical device set 91 can be used to treat head and neck aneurysms, arteriovenous malformations, arteriovenous fistulas, pulmonary vascular malformations, renal vascular malformations, renal artery, abdominal aneurysms, or other vascular lesions.

[0065] A medical instrument set according to a second embodiment will be described below with reference to Fig. 11. As shown in Fig. 11, a medical instrument set 92 according to the second embodiment includes a flexible container 8, a first tube 1, and a packaging bag 5 that contains the flexible container 8 and the first tube 1. The flexible container 8 has a lumen 8C filled with a liquid 8F and a discharge outlet 8L.

[0066] 11, the first tube 1 is not connected to the tip end 8b of the flexible container 8, but the flexible container 8 is configured to be directly or indirectly connected to the first tube 1. Specifically, in FIG. 11, the tip end 8b of the flexible container 8 is configured to be connected to the fitting portion 6G of the connecting member 6, but it may be configured to be connected to the base end 1a of the first tube 1 without going through the connecting member 6.

[0067] 11, the flexible container 8 preferably has a cap 8U at the tip 8b. This prevents the liquid 8F from leaking from the flexible container 8. The cap 8U is preferably made of resin. The cap 8U preferably contains polypropylene, polyvinyl chloride, polystyrene, acrylonitrile-styrene copolymer, polyoxymethylene, polyamide, acrylonitrile-butadiene-styrene copolymer, or a combination thereof.

[0068] As shown in FIG. 11, the medical instrument set 91 preferably has a backing 9M. The backing 9M preferably has slits 9S. For example, the flexible container 8 can be fixed to the backing 9M by inserting a string 9V into a pair of slits 9S in the backing 9M and inserting a part of the flexible container 8 between the string 9V and the backing 9M. The backing 9M preferably includes a resin layer, a paper layer, or a laminate thereof, and more preferably is made of a resin layer. The string 9V preferably includes a resin layer, a paper layer, or a laminate thereof, and more preferably is made of a resin layer.

[0069] When using the medical instrument set 92, the components are removed from the packaging bag 5, the cap 8U of the flexible container 8 is removed, the tip 8b of the flexible container 8 is connected to the fitting portion 6G of the connecting member 6, and the flexible container 8 is compressed to supply the liquid 8F into the first tube 1. For other configurations of the medical instrument set 92 according to the second embodiment, refer to the description of the medical instrument set 91 according to the first embodiment.

[0070] A medical instrument set according to the third embodiment will be described below with reference to Fig. 12. As shown in Fig. 12, a medical instrument set 93 according to the third embodiment includes a flexible container 8, a first tube 1, and a packaging bag 5 that contains the flexible container 8 and the first tube 1. As shown in Fig. 12, the first tube 1 is connected to the tip end 8b of the flexible container 8.

[0071] As shown in FIG. 12, the medical tool set 93 preferably further includes a filter 6F connected to the distal end 8b of the flexible container 8. This allows for filter sterilization. The filter 6F preferably includes a membrane and a housing incorporating the membrane. The proximal end of the housing of the filter 6F is preferably connected to the distal end 8b of the flexible container 8. The distal end of the housing is preferably connected to the proximal end 1a of the first tube 1. Note that the medical tool set 93 does not necessarily need to include the filter 6F; the proximal end 1a of the first tube 1 may be directly connected to the distal end 8b of the flexible container 8.

[0072] In Figure 12, the inner cavity 8C of the flexible container 8, the inner cavity 1C of the first tube 1, and the space 5C inside the packaging bag 5 are connected, so by removing each component from the packaging bag 5 and compressing the flexible container 8, liquid 8F can be supplied into the first tube 1 and ejected from the tip 1B of the first tube 1.

[0073] The liquid 8F preferably contains a drug. The drug preferably contains an anticoagulant, an antiplatelet drug, an anticancer drug, or a mixture thereof. For example, when containing an anticancer drug, the first tube 1 is inserted into the body so that the tip 1B of the first tube 1 is positioned near the malignant tumor, and the liquid 8F containing the anticancer drug is injected from the flexible container 8, thereby treating the malignant tumor. Examples of diseases that can be treated with anticancer drugs include stomach cancer, colon cancer, liver cancer, lung cancer, breast cancer, uterine cancer, and ovarian cancer.

[0074] When the drug contains an anticoagulant or antiplatelet drug, it can be used in combination with saline to perform procedures such as heparin lock or saline lock, in which the catheter is pre-filled with saline or the like to prevent blood from flowing back inside the catheter and clotting during intravenous infusion, etc.

[0075] The liquid 8F may contain a nutrient. In this case, for example, the tip 1B of the first tube 1 may be inserted into the digestive tract, and the liquid 8F containing the nutrient may be injected from the flexible container 8 to administer the nutrient. Such tube feeding is effective for patients who cannot take in nutrition due to swallowing disorders or the like. The first tube 1 may be inserted into the digestive tract via the nasal cavity, or may be inserted into the digestive tract via a fistula opened in the abdomen. Alternatively, an orally ingestible drug may be dissolved in water or other fluid as needed and used as the liquid 8F, and administered into the digestive tract via the first tube 1. In such a case, the medical equipment set 93 does not necessarily need to be used in a medical setting, but may also be used by the patient at home.

[0076] The longitudinal length of the first tube 1 is preferably longer than the shortest distance from the base end 8A to the tip end 8B of the flexible container 8. This makes it easier to use the medical instrument set 93 for the above-mentioned purposes. The longitudinal length of the first tube 1 is preferably 10 to 100 cm, and more preferably 20 to 60 cm.

[0077] Although not shown, the medical instrument set 93 may further include a backing sheet. The backing sheet may have flaps formed by slits, and the flexible container 8 and the first tube 1 may be fixed to the backing sheet by the flaps.

[0078] For other configurations of the medical instrument set 93 according to the third embodiment, refer to the description of the medical instrument set 91 according to the first embodiment. [Explanation of symbols]

[0079] 1. Tube 1 1a Proximal end 1B Tip 1C lumen 2 Second Tube 2A one end 2B other end 2C lumen 3. Intravital devices 3E Coil section 3H head section 4. Intra-body device delivery device 4A proximal end 4b Tip 5 Packaging bag 5C space 5E outer edge 6 Connecting members 6C lumen 6F filter 6G mating part 7 Tube Clips 8 Flexible container 8A proximal end 8B tip 8b Tip 8C lumen 8Ap: Part near the base 8Bp near the tip 8F Liquid 8L outlet 8M Blow Molding Section 8N pouch 8T straight pipe section 8U Cap 9C Clip 9M mount 9S slit 9V string 91, 92, 93 Medical equipment set

Claims

1. A first tube; a flexible container configured to connect to the first tube and having a lumen filled with a liquid and a discharge port; A medical device set comprising the first tube and a packaging bag containing the flexible container.

2. 2. The medical instrument set according to claim 1, wherein the flexible container has a flexible blow-molded portion, the blow-molded portion having at least a portion of the lumen.

3. 2. The medical instrument set according to claim 1, wherein the flexible container has a flexible bag-like portion, and the bag-like portion has at least a portion of the lumen.

4. The medical device set according to any one of claims 1 to 3, further comprising a clip that holds a part of the flexible container.

5. The medical device set according to any one of claims 1 to 3, wherein the flexible container is directly or indirectly connected to the first tube.

6. 6. The medical instrument set according to claim 5, wherein the inner cavity of the flexible container, the inner cavity of the first tube, and the space within the packaging bag are in communication with each other.

7. The medical device set according to any one of claims 1 to 3, further comprising a connecting member that connects the flexible container and the first tube and has an inner cavity that communicates with the inner cavity of the flexible container and the inner cavity of the first tube.

8. The medical device set according to any one of claims 1 to 3, wherein the liquid includes physiological saline.

9. The medical device set according to any one of claims 1 to 3, wherein the liquid contains a drug.

10. The medical device set according to claim 9, wherein the drug comprises an anticoagulant, an antiplatelet drug, an anticancer drug, or a mixture thereof.

11. The medical device set according to any one of claims 1 to 3, further comprising an in-vivo indwelling device at least a portion of which is disposed in the lumen of the first tube, and a long in-vivo indwelling device delivery device having the in-vivo indwelling device disposed at its distal end.

12. 12. The medical device set according to claim 11, wherein the in-vivo indwelling device is detachably connected to a distal end of the in-vivo indwelling device delivery device.

13. The medical device set according to claim 11, wherein the in-vivo indwelling device has a coil portion.

14. The medical tool set according to claim 11, further comprising a second tube, wherein at least a portion of the first tube is disposed within the lumen of the second tube.

15. The medical tool set according to claim 14, wherein the second tube is wound.

16. 16. The medical device set according to claim 15, wherein a portion of the first tube is exposed from one longitudinal end of the second tube, and a portion of the in-vivo indwelling device delivery device is exposed from the other longitudinal end of the second tube.

17. The medical device set according to any one of claims 1 to 3, wherein the liquid is not present in the lumen of the first tube.

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