Medical instrument

Abstract

Provided is a medical instrument in which connection between a syringe and a tube is not loosened easily even in a high-temperature environment, and which is easy to use. This medical instrument includes: a syringe filled with a liquid in a lumen; a first tube directly or indirectly connected to a tip part of the syringe; and a packaging bag including the syringe and the first tube. The lumen of the syringe, a lumen of the first tube, and the space in the packaging bag communicate with each other.

Description

medical equipment

[0001] The present invention relates to a medical device having a syringe filled with a liquid, a tube, and a packaging bag containing these.

[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 procedures to prevent blood clotting and blockage in a catheter, known as heparin lock. Patent Document 1, for example, discloses a heparin-containing prefilled syringe preparation obtained by filling a syringe with a heparin solution containing approximately 160 to 1000 units / mL of heparin and subjecting the syringe to autoclave. Patent Document 1 also describes a method of autoclave sterilization in which a cap is attached to the open tip of the syringe, the heparin solution is filled into the open base of the syringe using a nozzle, and a gasket is attached to the open base, resulting in a prefilled syringe preparation containing the heparin solution, which is then autoclave sterilized.

[0003] Embolization, which involves placing an in-vivo device such as a coil within an aneurysm to promote thrombosis and thereby 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 extending within the first lumen and fixedly attached to the delivery catheter at a position adjacent to the distal portion of the delivery catheter, and 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 a catheter by applying hydraulic pressure in a syringe.

[0004] JP 2006-169214 A JP 2003-102842 A

[0005] As described above, tubes such as catheters and syringes are used in a variety of procedures. The inventors believed that if tubes were pre-connected to syringes filled with liquid, the connection process could be omitted in medical settings. However, they found that if a cap is attached to the tip of a tube during high-temperature sterilization, the high temperature can cause gas inside the catheter to expand, resulting in the cap coming off. On the other hand, if a cap is firmly attached to the tip of the tube to prevent the cap from coming off, pressure due to the expansion of internal gas can be applied to the connection between the syringe and the tube during high-temperature sterilization, causing the connection to loosen and resulting in liquid leakage. Furthermore, in summer, high temperatures can occur during transportation or storage, causing the gas inside the tube to expand. The present invention was developed in response to the above-mentioned circumstances, and its purpose is to provide a medical device that is easy to use and that is resistant to loosening of the syringe-tube connection, even in high-temperature environments.

[0006] The medical device according to the embodiment that can solve the above problems is as follows: [1] A medical device comprising: a syringe having an inner cavity filled with a liquid, a first tube connected directly or indirectly to the tip of the syringe, and a packaging bag that contains the syringe and the first tube, wherein the inner cavity of the syringe, the inner cavity of the first tube, and a space within the packaging bag are in communication with each other.

[0007] As described above, the lumen of the syringe, the lumen of the first tube, and the space within the packaging bag are in communication with each other, so that even if gas in the tube expands in a high-temperature environment, the gas can move to the space within the packaging bag, making the connection between the syringe and the tube less likely to loosen. Furthermore, in addition to this communication configuration, the syringe is pre-filled with liquid and the first tube is connected, so that, for example, in a medical setting, the work of connecting the syringe and the tube and the work of removing the cap can be omitted, making the medical device easier to use.

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

[16] . [2] The medical device according to [1], wherein the liquid contains physiological saline. [3] The medical device according to [1] or [2], wherein the liquid contains a drug. [4] The medical device according to [3], wherein the drug contains an anticoagulant, an antiplatelet drug, an anticancer drug, or a mixture thereof. [5] The medical device according to any one of [1] to [4], further comprising a connecting member connecting the syringe and the first tube and having an inner cavity communicating with the inner cavity of the syringe and the inner cavity of the first tube. [6] The medical device according to [5], wherein the syringe has a threaded portion having a helical groove or a helical convex portion, and the connecting member has a fitting portion fitting with the threaded portion. [7] The medical device according to any one of [1] to [6], wherein the syringe has an outer cylinder and a plunger having at least a tip portion disposed in the inner cavity of the outer cylinder. [8] The medical device according to [7], wherein the outer tube has a first protrusion protruding inward, and the plunger has a second protrusion located closer to the base end than the first protrusion. [9] The medical device according to any one of [1] to [8], 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.

[10] The medical device according to [9], wherein the in-vivo indwelling device is detachably connected to the distal end of the in-vivo indwelling device delivery device.

[11] The medical device according to [9] or

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

[12] The medical device according to any one of [1] to

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

[13] The medical device according to

[12] , wherein the second tube is wound.

[14] The medical device according to

[12] or

[13] , 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.

[15] The medical device according to any one of [1] to

[14] , wherein the liquid is not present in the lumen of the first tube.

[16] The medical device according to any one of [5] to

[15] , further comprising a filter connected to the tip of the syringe and the connecting member.

[0009] According to the present invention, it is possible to provide a medical device in which the connection between the syringe and the tube is unlikely to loosen even in a high-temperature environment and which is easy to use.

[0010] Fig. 1 is a plan view of a medical device according to a first embodiment. Fig. 2 is a plan view of Fig. 1 with the packaging bag, second tube, and clip omitted. Fig. 3 is an enlarged view of the vicinity of the connecting member in Fig. 2. Fig. 4 is an enlarged view of the vicinity of the connecting member in a modified example of the syringe and connecting member in Fig. 2. Fig. 5 is a side view of the vicinity of the tip of the first tube in Fig. 2. Fig. 6 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. 7 is a plan view of a medical device according to a second embodiment.

[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. Note that, for convenience, component reference numerals may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. Furthermore, 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] The medical device according to the embodiment includes a syringe having a lumen filled with a liquid, a first tube connected directly or indirectly to the tip of the syringe, and a packaging bag containing the syringe and the first tube, with the lumen of the syringe, the lumen of the first tube, and the space within the packaging bag communicating with each other. Because the lumen of the syringe, the lumen of the first tube, and the space within the packaging bag communicate with each other as described above, even if gas in the tube expands in a high-temperature environment, the gas can move to the space within the packaging bag, making the connection between the syringe and the tube less likely to loosen. Furthermore, in addition to this communication configuration, the syringe is pre-filled with a liquid and connected to the first tube, which eliminates the need to connect the syringe and the tube and remove the cap in a medical setting, making the medical device easier to use.

[0013] A medical device according to a first embodiment will be described below with reference to Figures 1 to 6. Figure 1 is a plan view of the medical device according to the first embodiment, and Figure 2 is a plan view of Figure 1 with the packaging bag, second tube, and clip omitted. Figure 3 is an enlarged view of the vicinity of the connecting member in Figure 2, and Figure 4 is an enlarged view of the vicinity of the connecting member in a modified version of the syringe and connecting member in Figure 2. Figure 5 is a side view of the vicinity of the tip of the first tube in Figure 2, and Figure 6 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 Figure 2.

[0014] As shown in FIG. 1 , the medical device 91 according to the first embodiment includes a syringe 8, a first tube 1, and a packaging bag 5 containing the syringe 8 and the first tube 1. As shown in FIG. 3 , the first tube 1 is connected to the distal end 8b of the syringe 8. Furthermore, the lumen 8C of the syringe 8, the lumen 1C of the first tube 1, and the space 5C within the packaging bag 5 are connected to each other. This communication structure allows expanded gas within the lumen 1C of the first tube 1 to move from the distal end 1B of the first tube 1 shown in FIGS. 2 and 5 to the space 5C within the packaging bag 5 when the temperature around the medical device 91 rises to a high temperature. As a result, pressure due to gas expansion is less likely to be applied between the distal end 8b of the syringe 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. Furthermore, since the first tube 1 is connected to the tip 8b of the syringe 8 in advance, the work of connecting the first tube 1 to the tip 8b of the syringe 8 in the medical field can be omitted, thereby improving work efficiency.

[0015] As shown in FIG. 3 , the medical device 91 preferably includes a connecting member 6 that connects the syringe 8 and the first tube 1 and has a lumen 6C that communicates with the lumen 8C of the syringe 8 and the lumen 1C of the first tube 1. When the medical device 91 includes the connecting member 6, the lumen 8C of the syringe 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 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 move 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 syringe 8 via the connecting member 6, but may also be directly connected to the distal end 8b of the syringe 8. In the case of a direct connection, for example, the proximal end 1a of the first tube 1 may be disposed within the distal end 8b of the syringe 8, or the distal end 8b of the syringe 8 may be disposed within the proximal end 1a of the first tube 1.

[0016] 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 tip end 8b of the syringe 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 below) 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. 4 (described below), the connecting member 6 may have an opening to which a filter 6F is connected instead of the tip end 8b of the syringe 8. As shown in FIGS. 3 and 4, the connecting member 6 preferably has a branched structure. This makes it easier to avoid contact between the syringe 8 and other components.

[0017] As shown in FIG. 3 , the syringe 8 preferably has a threaded portion 8E having a spiral groove or a spiral convex portion. The connecting member 6 preferably has a fitting portion 6G that fits with the threaded portion 8E. This makes it easier to fix the syringe 8 to the connecting member 6. As shown in FIG. 3 , the tip portion 8b of the syringe 8 preferably has a so-called luer lock structure. For example, the inner surface of the cylindrical tip portion 8b preferably has a threaded portion 8E having a spiral groove or a convex portion, and the outer surface of the cylindrical fitting portion 6G is preferably configured to be able to fit with the threaded portion 8E. On the other hand, although not shown, the opposite configuration may also be adopted, in which the outer surface of the cylindrical tip portion 8b has a threaded portion 8E having a spiral groove or a convex portion, and the inner surface of the cylindrical fitting portion 6G is configured to be able to fit with the threaded portion 8E.

[0018] As shown in FIG. 3 , the proximal end 1 a 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 1 a 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 1 a 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 positioned within the connecting member 6, the proximal end 1 a of the first tube 1 is more unlikely to come off the connecting member 6.

[0019] The connecting member 6 preferably contains an acrylic resin, a polyester resin, a polycarbonate resin, a 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.

[0020] As shown in FIG. 1 , the syringe 8 has a lumen 8C, which is filled with a liquid 8F. This eliminates the need to fill the syringe 8 with liquid after removing the syringe 8 connected to the first tube 1 from the packaging bag 5, thereby reducing the workload in, for example, a medical facility. Furthermore, it is possible to prevent bacteria and dust from being mixed in when filling the syringe 8 in a medical facility. The liquid surface of the liquid 8F is preferably located within the tip 8b of the syringe 8, but may be located within the connecting member 6 or the first tube 1. The lumen 8C of the syringe 8 preferably does not contain gas, but may contain gas. Examples of gas include air and sterilizing gas.

[0021] 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 syringe 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%. In other words, physiological saline is most preferably a saline solution. This allows, for example, flushing operations to be performed. A 0.9 w / v% saline solution can be prepared, for example, by dissolving 0.900 g of sodium chloride in purified water to make 100 mL.

[0022] The liquid 8F preferably 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.

[0023] The anticoagulant preferably includes heparin, low molecular weight heparin, a direct thrombin inhibitor, a 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.

[0024] 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.

[0025] 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, if the medical device 91 described below 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.

[0026] 4, the medical device 91 may further include a filter 6F connected to the tip 8b of the syringe 8 and the connecting member 6. Because the syringe 8 and the first tube 1 are disposed within the packaging bag 5, they can basically maintain a sterile state after sterilization, but 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 syringe 8, the filtered and sterilized liquid 8F can be supplied to the first tube 1.

[0027] The filter 6F preferably has a membrane and a housing incorporating the membrane. That is, the filter 6F is preferably a syringe filter. As shown in FIG. 4, the base end of the housing of the filter 6F is preferably connected to the tip 8b of the syringe 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 preferably have a threaded portion or a structure that can be fitted with a threaded portion.

[0028] 3 and 4, the syringe 8 preferably includes an outer cylinder 81 and a plunger 82 having at least a tip portion 82b disposed in a lumen 81C of the outer cylinder 81. The plunger 82 is fixed in a pulled state toward the base end, and in use, the liquid 8F in the outer cylinder 81 can be supplied to the first tube 1 by releasing the lock described below and pushing the plunger 82 from the base end toward the tip end.

[0029] A gasket 82G is preferably fixed to the tip 82b of the plunger 82. The gasket 82G can be tightly attached to the inner wall of the outer cylinder 81, and therefore the gasket 82G can prevent leakage of the liquid 8F from the tip 82b of the plunger 82. Lubricating oil may be attached to the gasket 82G.

[0030] As shown in Figures 3 and 4, the outer tube 81 preferably has a first protrusion 81P protruding inward. Furthermore, the plunger 82 preferably has a second protrusion 82P located closer to the base end than the first protrusion 81P. The second protrusion 82P protrudes from the inside to the outside, and when a force is applied to the plunger 82 in a direction from the base end to the tip end, the movement of the second protrusion 82P is inhibited by the first protrusion 81P, thereby preventing the plunger 82 from moving toward the tip end. This locking structure prevents leakage of the liquid 8F associated with movement of the plunger 82 before use. Furthermore, even when a force is applied to the plunger 82 in a direction from the tip end to the base end, the second protrusion 82P inhibits movement of the gasket 82G, making it easier to prevent the plunger 82 from detaching from the outer tube 81.

[0031] The second protrusion 82P preferably extends in a portion of the circumferential direction of the pusher 82. By having the second protrusion 82P extend in the circumferential direction, the second protrusion 82P and the first protrusion 81P are more likely to come into contact with each other, making it easier to activate the locking mechanism. On the other hand, by having the second protrusion 82P in a portion of the circumferential direction, in other words, by not having the second protrusion 82P in another portion of the circumferential direction, it is possible to release the lock by, for example, rotating the pusher 82 in the circumferential direction so that the first protrusion 81P and the second protrusion 82P do not come into contact with each other, and then the pusher 82 can be pushed toward the tip side.

[0032] The outer cylinder 81 and the plunger 82 each preferably contain a resin. The resin preferably contains polyethylene, polypropylene, polystyrene, or a combination thereof. This reduces costs and makes the syringe 8 suitable for use as a disposable syringe. The gasket 82G preferably contains a thermoplastic elastomer or rubber such as butyl rubber.

[0033] As shown in FIG. 5 , the medical device 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 site via the first tube 1. The in-vivo indwelling device 3 may also be delivered to the lesion site via a tube other than the first tube 1. The in-vivo indwelling device 3 is preferably located in a region 1 mm or more and 10 cm or less, and more preferably 2 mm or more and 5 cm or less, away from the distal end 1B of the first tube 1. This facilitates protection of the in-vivo indwelling device 3 by the first tube 1 and also facilitates exposing the first tube 1 from the distal end 1B during use.

[0034] As shown in Figure 6, 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.

[0035] The coil portion 3E of the in-vivo indwelling device 3 is preferably connected to another member such as the long in-vivo indwelling device delivery device 4 described below, but does not have to be connected to another member. When it is not connected to another member, for example, the in-vivo indwelling device 3 can be placed in the lesion by applying water pressure to the in-vivo indwelling device 3 placed in the first tube 1 and discharging the in-vivo indwelling device 3 from the tip 1B of the first tube 1.

[0036] As shown in Figure 5, the coil portion 3E preferably has a helical primary shape. Furthermore, as shown in Figure 6, the coil portion 3E preferably has a secondary shape in which the helical primary shape is further formed into a helical or three-dimensional shape. Specifically, the coil portion 3E preferably has a secondary shape when exposed from the first tube 1. This makes it easier to occlude the aneurysm. The coil portion 3E preferably has one or more wires. It is preferable that one or more wires have the above-mentioned helical primary shape or secondary shape. The coil portion 3E may also have fibers to promote thrombosis within the aneurysm.

[0037] 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. 6, 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.

[0038] The wire of the coil portion 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 portion 3E may contain a radiopaque material. The cross-sectional shape of the wire in a direction perpendicular to the longitudinal direction of the coil portion 3E may be circular, elliptical, polygonal, or a combination thereof. The elliptical shape includes an elliptical 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.

[0039] The coil portion 3E preferably contains a hydrophilic resin. By including a hydrophilic resin, the coil portion 3E is more likely to swell when moisture is supplied to the coil portion 3E, which in turn makes 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.

[0040] 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.

[0041] As shown in Figures 5 and 6, the medical device 91 preferably has a long in-vivo indwelling device delivery device 4 with an in-vivo indwelling device 3 disposed at its distal end. The distal end of the in-vivo indwelling device delivery device 4 refers to the distal end portion when the in-vivo indwelling device delivery device 4 is longitudinally divided into a distal end portion and a proximal end portion. Specifically, the in-vivo indwelling device 3 is preferably detachably coupled to the distal end portion 4b of the distal end portion of the in-vivo indwelling device delivery device 4. For example, by deforming the distal end portion 4b of the in-vivo indwelling device delivery device 4 within the lesion, the in-vivo indwelling device 3 can be detached from the in-vivo indwelling device delivery device 4 and placed in the lesion. Examples of deformation of the distal end portion 4b of the in-vivo indwelling device delivery device 4 include melting, electrolysis, mechanical release of engagement, and a combination of these. Examples of fusing and electrolysis include fusing or electrolysis of the tip 4b of the in-vivo indwelling 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 applied to generate Joule heat near the tip 4b, thereby fusing the tip 4b. Examples of mechanical release of engagement include 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 detachably connected to a portion of the tip side of the in-vivo indwelling device delivery device 4 other than the tip 4b.

[0042] The distal end 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 more preferably contains polyvinyl alcohol. These are preferred because they are prone to melting when heated and electrolysis when current is applied. The distal end 4b of the in-vivo indwelling device delivery device 4 is preferably tubular, rod-like, or a combination thereof.

[0043] As shown in Figures 5 and 6, 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 elongated body, a tube, or a combination of these. For example, the solid elongated 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 thereof, and more preferably contains stainless steel. Furthermore, the solid elongated 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 elongated bodies.

[0044] 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.

[0045] The above description has mainly focused on cases where the in-vivo indwelling device 3 is a coil, but in cases 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.

[0046] The longitudinal length of the first tube 1 is preferably longer than the axial length of the outer cylinder 81 of the syringe 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. The tip portion 8b and the flange portion are included in the outer cylinder 81.

[0047] 1, the medical device 91 preferably further includes a second tube 2. Specifically, the medical device 91 preferably further includes the second tube 2 contained in a packaging bag 5. It is preferable that at least a portion of the first tube 1 is disposed in the inner cavity 2C of the second tube 2. The second tube 2 can protect the first tube 1 from external pressure.

[0048] As shown in Fig. 1, the second tube 2 is preferably wound. This allows the size of the packaging bag 5 to be reduced. Furthermore, as shown in Fig. 2, at least a portion of the first tube 1 disposed within the second tube 2 can be wound. When the arrangement shown in Fig. 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.

[0049] 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.

[0050] As shown in Figure 1, it is preferable that a portion of the in-vivo indwelling 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 indwelling device delivery device 4 from the other end 2B of the second tube 2 during use. During use, the in-vivo indwelling device 3 can be exposed from the tip 1B of the first tube 1 by pushing the in-vivo indwelling device delivery device 4 in a direction 4C from the base end to the tip of the in-vivo indwelling device delivery device 4 as shown in Figure 2.

[0051] 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.

[0052] The first tube 1 is preferably biocompatible and 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.

[0053] 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, polyimide resin, or a mixture thereof. The second tube 2 preferably contains a resin with a higher Shore D hardness than the resin contained in the first tube 1. This makes it easier for the second tube 2 to protect the first tube 1. The Shore hardness can be measured, for example, based on ISO 868:2003 Plastic Durometer Hardness Test Method using a Type D durometer.

[0054] 1, the second tube 2 is preferably fixed in its wound shape by a plurality of clips 7. The clips 7 preferably have a plurality of grooves or through holes into which the second tube 2 can be fitted.

[0055] As shown in FIG. 1 , the packaging bag 5 contains the syringe 8, the first tube 1, and the like. 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 syringe 8, the first tube 1, and the like. 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 a single sheet and joining the outer edges of the overlapping portion. These outer edges are preferably joined by heat sealing.

[0056] 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.

[0057] 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, making it easier to sterilize the interior of the packaging bag 5 with ethylene oxide gas. 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.

[0058] The medical device 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.

[0059] A medical device according to a second embodiment will be described below with reference to Fig. 7. As shown in Fig. 7, a medical device 92 according to the second embodiment includes a syringe 8, a first tube 1, and a packaging bag 5 that contains the syringe 8 and the first tube 1. As shown in Fig. 7, the first tube 1 is connected to the tip 8b of the syringe 8. Furthermore, the lumen 8C of the syringe 8, the lumen 1C of the first tube 1, and the space 5C within the packaging bag 5 are in communication with each other.

[0060] As shown in Figure 7, the medical device 92 preferably further includes a filter 6F connected to the distal end 8b of the syringe 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 syringe 8. The distal end of the housing is preferably connected to the proximal end 1a of the first tube 1. Note that the medical device 92 does not necessarily need to include the filter 6F, and the proximal end 1a of the first tube 1 may be directly connected to the distal end 8b of the syringe 8.

[0061] 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 the liquid 8F contains 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 syringe 8 to treat 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.

[0062] 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.

[0063] The liquid 8F may contain a nutrient. In this case, for example, the distal end 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 syringe 8 to administer the nutrient. Such tube feeding is effective for patients who are unable to 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 via a fistula opened in the abdomen. Furthermore, 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 cases, the medical device 92 does not necessarily need to be used in a medical setting, but may also be used by the patient at home.

[0064] The longitudinal length of the first tube 1 is preferably longer than the axial length of the outer cylinder 81 of the syringe 8. This makes it easier to use the medical device 92 for the above-mentioned applications. The longitudinal length of the first tube 1 is preferably 10 to 100 cm, and more preferably 20 to 60 cm. The tip portion 8b and the flange portion are included in the outer cylinder 81.

[0065] Although not shown, the medical device 92 may further have a backing sheet. The backing sheet may have flaps formed by slits, and the syringe 8 and the first tube 1 may be fixed to the backing sheet by the flaps.

[0066] For other configurations of the medical device 92 according to the second embodiment, the description of the medical device 91 according to the first embodiment may be referred to.

[0067] This application claims the benefit of priority based on Japanese Patent Application No. 2024-048516, filed on March 25, 2024. The entire contents of the specification of Japanese Patent Application No. 2024-048516, filed on March 25, 2024, are incorporated herein by reference.

[0068] DESCRIPTION OF SYMBOLS 1 First tube 1a Base end 1B Distal end 1C Lumen 2 Second tube 2A One end 2B Other end 2C Lumen 3 In-vivo indwelling device 3E Coil portion 3H Head portion 4 In-vivo indwelling device delivery device 4A Base end 4b Distal portion 5 Packaging bag 5C Space 5E Outer edge 6 Connecting member 6C Lumen 6F Filter 6G Fitting portion 7 Clip 8 Syringe 8b Distal portion 8C Lumen 8E Threaded portion 8F Liquid 81 Sheath 81C Lumen 81P First protrusion 82 Pusher 82b Distal portion 82P Second protrusion 82G Gasket 91, 92 Medical device

Claims

1. A medical device comprising: a syringe having an inner cavity filled with a liquid; a first tube connected directly or indirectly to the tip of the syringe; and a packaging bag containing the syringe and the first tube, wherein the inner cavity of the syringe, the inner cavity of the first tube, and the space within the packaging bag are in communication.

2. The medical device of claim 1, wherein the liquid comprises saline.

3. The medical device according to claim 1 or 2, wherein the liquid contains a drug.

4. The medical device of claim 3, wherein the drug comprises an anticoagulant, an antiplatelet agent, an anticancer agent, or a mixture thereof.

5. A medical device according to claim 1 or 2, further comprising a connecting member connecting said syringe and said first tube, said connecting member having an inner cavity communicating with said inner cavity of said syringe and said inner cavity of said first tube.

6. The medical device according to claim 5, wherein the syringe has a threaded portion with a spiral groove or a spiral protrusion, and the connecting member has a fitting portion that fits into the threaded portion.

7. The medical device according to claim 1 or 2, wherein the syringe has an outer cylinder and a plunger having at least a tip portion disposed in the inner cavity of the outer cylinder.

8. The medical device according to claim 7, wherein the outer cylinder has a first protrusion protruding inward, and the plunger has a second protrusion located closer to the base end than the first protrusion.

9. The medical device according to claim 1 or 2, further comprising an in-vivo device at least a portion of which is disposed in the lumen of the first tube, and a long in-vivo device delivery device having the in-vivo device disposed at its distal end.

10. The medical device according to claim 9, wherein the in-vivo indwelling device is detachably connected to the distal end of the in-vivo indwelling device delivery device.

11. The medical device according to claim 9, wherein the in-vivo indwelling device has a coil portion.

12. The medical device according to claim 9, further comprising a second tube, the lumen of which contains at least a portion of the first tube.

13. The medical device of claim 12, wherein said second tube is wound.

14. The medical device according to claim 13, 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.

15. The medical device according to claim 1 or 2, wherein the liquid is not present in the lumen of the first tube.

16. The medical device according to claim 5, further comprising a filter connected to said tip end of said syringe and said connecting member.

Images