WO2025204614A1 - Medical instrument - Google Patents

Abstract

Provided is a medical instrument configured so that it is possible to maintain a three-dimensional shape even when a coil that includes a drug is stored for a long period of time. The medical instrument includes: a coil that includes a drug; a long coil delivery tool at the tip side of which the coil is disposed; a first tube having a bore in which at least a section of the coil delivery tool is disposed; and a packaging bag that contains therein the coil, the coil delivery tool, and the first tube. At least a section of the coil is exposed from the tip of the first tube.

Description

medical equipment

The present invention relates to a medical device comprising a coil containing a drug, a coil delivery device, a tube, and a packaging bag containing these.

Embolization, a technique for preventing aneurysm rupture by placing an in-vivo device such as a coil within an aneurysm to promote thrombosis, is known. Patent Document 1, 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 polymer material, a first lumen, a second lumen with a side opening, and a puller wire. The side opening is located at a predetermined position within the intermediate portion of the delivery catheter, and 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 bends the relatively flexible intermediate portion, thereby moving the side opening laterally relative to the delivery catheter. Patent Document 1 also describes how an embolic coil can be delivered into an aneurysm via the catheter by applying fluid pressure in a syringe.

Japanese Patent Application Laid-Open No. 2003-102842

As described above, procedures are performed to place in-vivo devices such as coils within lesions such as aneurysms. The coils used in these procedures are stored in a stretched state within a tube such as a catheter before use. The inventors' research has revealed that if a coil pre-loaded with a drug is stored in a stretched state within a tube for an extended period of time, the drug will maintain the stretched state even when exposed from the tube, making it difficult for the coil to assume a three-dimensional shape. The present invention was made in light of the above circumstances, and its purpose is to provide a medical device that allows a drug-loaded coil to maintain its three-dimensional shape even when stored for an extended period of time.

The medical device according to the embodiment that can solve the above problems is as follows.
[1] A coil having a drug;
a long coil delivery tool having the coil disposed at its distal end;
a first tube having at least a portion of the coil delivery tool disposed in an inner lumen thereof;
a packaging bag containing the coil, the coil delivery tool, and the first tube,
A medical device in which at least a portion of the coil is exposed from the tip of the first tube.

As described above, by exposing at least a portion of the coil containing the drug from the tip of the first tube, the coil is more likely to maintain its three-dimensional shape than if the entire coil were stored in an extended state within the first tube. Furthermore, by enclosing these components in a packaging bag, the coil is also more likely to maintain its three-dimensional shape.

The medical device according to the embodiment is preferably any one of the following items [2] to [15].
[2] The medical device according to [1], wherein the coil is detachably connected to the tip of the coil delivery tool.
[3] The medical device according to [1] or [2], further comprising a second tube, wherein at least a portion of the first tube is disposed in the lumen of the second tube.
[4] The medical device according to [3], wherein at least a portion of the coil is exposed from the tip of the second tube.
[5] The medical device according to [3] or [4], wherein the coil is disposed in the inner cavity of the second tube.
[6] The device further includes a tip member connected to the tip end of the second tube and having an inner cavity communicating with the inner cavity of the second tube,
The medical device according to any one of [3] to [5], wherein at least a portion of the coil is disposed in the lumen of the tip member.
[7] The medical device according to [6], wherein the tip member is flat and the thickness of the tip member is greater than the outer diameter of the second tube.
[8] The medical device according to [6] or [7], wherein the tip member has a through-hole that communicates with the inner cavity of the tip member and the space inside the packaging bag.
[9] The tip member has a leaf spring,
The medical device according to any one of [6] to [8], wherein the tip of the second tube is fixed to the tip member by the leaf spring.
[10] A medical device according to any one of [3] to [9], wherein the second tube has a through hole on its outer surface that communicates with the inner cavity of the second tube.
[11] The medical device according to any one of [3] to [10], wherein the second tube is wound.
[12] A medical device according to any one of [3] to [11], wherein the coil is not in contact with the second tube.
[13] The medical device according to any one of [6] to [12], wherein the coil is not in contact with the tip member.
[14] A medical device described in any one of [1] to [13], wherein the portion of the coil exposed from the tip of the first tube is continuously curved and does not have a straight portion.
[15] A medical device according to any one of [1] to [14], wherein the entire coil is exposed from the tip of the first tube.

The present invention provides a medical device that allows a drug-loaded coil to maintain its three-dimensional shape even when stored for an extended period of time.

FIG. 1 is a plan view of a medical device according to a first embodiment. FIG. 2 is a plan view of FIG. 1 in which the packaging bag, the second tube, and the clip are omitted. FIG. 3 is an enlarged side view of the vicinity of the tip member of FIG. FIG. 4 is a side view of the vicinity of the tip of the first tube when the coil of FIG. 3 is pulled into the first tube. FIG. 5 is an enlarged view of the vicinity of the connecting member in FIG. FIG. 6 is a plan view of the medical device according to the second embodiment. 7 is an enlarged side view of the vicinity of the tip end of the second tube in FIG. 6. FIG.

The present invention will be described in more detail below based on the following embodiments, but the present invention is not limited to these embodiments and can of course be implemented with appropriate modifications within the scope of the intent described above and below, all of which are encompassed within the technical scope of the present invention. For convenience, component reference numbers may be omitted from the drawings; in such cases, reference should be made to the specification or other drawings. The dimensions of the various components in the drawings may differ from their actual dimensions, as priority is given to aiding understanding of the features of the present invention.

The medical device according to this embodiment comprises a coil containing a drug, a long coil delivery device with the coil located at its tip, a first tube with at least a portion of the coil delivery device located in its lumen, and a packaging bag containing the coil, coil delivery device, and first tube, with at least a portion of the coil exposed from the tip of the first tube. By exposing at least a portion of the coil containing the drug from the tip of the first tube as described above, the coil is more likely to maintain its three-dimensional shape than if the entire coil were stored in an extended state within the first tube. Furthermore, by having these items contained in a packaging bag, the coil is also more likely to maintain its three-dimensional shape.

The medical device according to the first embodiment will be described below with reference to Figures 1 to 5. Figure 1 is a plan view of the medical device according to the first embodiment. Figure 2 is a plan view of Figure 1 with the packaging bag, second tube, and clip omitted. Figure 3 is an enlarged side view of the vicinity of the tip member in Figure 1. Figure 4 is a side view of the vicinity of the tip of the first tube when the coil in Figure 3 has been pulled into the first tube. Figure 5 is an enlarged view of the vicinity of the connecting member in Figure 2. Note that Figure 3 illustrates a case in which the tip member is made of a transparent material. The tip member and second tube are omitted from Figure 4.

1, 2, and 3, the medical device 91 includes a coil 3 containing a drug, a long coil delivery device 4 with the coil 3 disposed at its distal end, a first tube 1 with at least a portion of the coil delivery device 4 disposed in its lumen 1C, and a packaging bag 5 containing these. Furthermore, at least a portion of the coil 3 is exposed from the distal end 1B of the first tube 1. As shown in FIG. 3, by storing the first tube 1 with at least a portion of the coil 3 containing the drug exposed from the distal end 1B, the coil 3 is more likely to maintain its three-dimensional shape than when the entire coil 3 is stored within the first tube 1 in an extended state, as shown in FIG. 4, for example. Furthermore, since the packaging bag 5 contains the coil 3 and other components, the coil 3 is protected by at least the packaging bag 5, and the coil 3 is more likely to maintain its three-dimensional shape. It is sufficient that at least a portion of the coil 3 is exposed from the distal end 1B of the first tube 1; it does not need to be exposed in a manner visible from outside the packaging bag 5, but it may be exposed in a manner visible from outside the packaging bag 5. Each component is described in detail below.

The coil 3 contains a drug. The drug preferably includes an embolic agent, an anti-inflammatory agent, an antibiotic agent, or a combination thereof. The embolic agent preferably includes a hydrophilic resin, a cyanoacrylate-based agent, or a combination thereof, and more preferably includes a hydrophilic resin. The hydrophilic resin preferably includes polyvinyl alcohol. The polyvinyl alcohol preferably includes a polyvinyl alcohol cross-linked polymer, a polyvinyl alcohol water-absorbing gel freeze-thaw elastomer, an ethylene-vinyl alcohol copolymer, or a combination thereof. These hydrophilic resins swell with water, making them more likely to fill the space within the aneurysm. The cyanoacrylate-based agent preferably includes N-butyl-2-cyanoacrylate. N-butyl-2-cyanoacrylate polymerizes on contact with plasma, thereby promoting thrombus formation within the aneurysm. Anti-inflammatory agents include non-steroidal anti-inflammatory drugs, NF-kB inhibitors, TNF-α inhibitors, statin drugs, etc. Antibiotics include β-lactam antibiotics such as ampicillin, and aminoglycoside antibiotics such as gentamicin.

The drug is preferably attached to the wire and/or fiber described below. The manner of attachment is not particularly limited, but examples include an embodiment in which the drug is attached directly to the coil 3, an embodiment in which a resin containing the drug is attached to the coil 3, or an embodiment in which the drug is attached to a recess on the surface of the coil 3. When the drug is attached to a recess, the recess and drug may be covered with the resin. These attachment resins preferably contain a bioabsorbable polymer, a membrane component similar to a biological membrane, or a combination of these. These attachment resins may also contain a diffusible substance that diffuses in the blood. The diffusible substance preferably contains dimethyl sulfoxide.

The bioabsorbable polymer preferably includes a natural polymer, a synthetic polymer, or a mixture thereof. Natural polymers preferably include collagen, gelatin, fibrinogen, carboxymethylcellulose, chitin, chitosan, glycosaminoglycan, hyaluronic acid, alginic acid, or a mixture thereof. Synthetic polymers preferably include polycaprolactone, polylactic acid, polyglycolic acid, polydioxanone, lactic acid-glycolic acid copolymer, L-lactide-ε-caprolactone copolymer, or a mixture thereof. The membrane component similar to a biological membrane preferably includes a phosphorylcholine polymer.

By placing the coil 3 in the affected area, such as an aneurysm, it is possible to prevent the vascular lesion from worsening. For example, by placing the coil 3 inside a cerebral aneurysm, it is possible to occlude the cerebral aneurysm and reduce the risk of rupture.

Coil 3 preferably has a helical primary shape. Furthermore, as shown in Figure 3, coil 3 more preferably has a secondary shape in which the helical primary shape is further formed into a helical or other three-dimensional shape. This makes it even easier to occlude the aneurysm. Coil 3 preferably has one or more wires. It is preferable that one or more wires have the above-mentioned helical primary shape or secondary shape. Coil 3 may also have fibers to promote thrombosis within the aneurysm.

As shown in Figure 3, it is preferable that the portion of the coil 3 exposed from the tip 1B of the first tube 1 is continuously curved and does not have any straight portions. In other words, by leaving at least a portion of the coil 3 unstretched, the coil 3 is more likely to maintain its three-dimensional shape. As for straight portions, for example, in Figure 4, the entire coil 3 is straight. Furthermore, the portion of the coil 3 exposed from the tip 1B of the first tube 1 does not need to be curved with the same radius of curvature overall; it may have multiple portions with different radii of curvature, or it may have a portion where the radius of curvature decreases from the base end to the tip end.

The outer diameter of coil 3 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. If coil 3 has a secondary shape as shown in FIG. 3, this outer diameter is the outer diameter of the coil when the secondary shape of coil 3 is linear as shown in FIG. 4.

The wire of coil 3 is preferably biocompatible and flexible. The wire preferably contains platinum, gold, titanium, tungsten, tantalum, iridium, palladium, alloys thereof, stainless steel, or combinations thereof, and more preferably contains a platinum-tungsten alloy. The wire of coil 3 may contain a radiopaque material. The cross-sectional shape of the wire in a direction perpendicular to the longitudinal direction of coil 3 may be circular, elliptical, polygonal, or a combination thereof. Elliptical shapes include oval and oval shapes. Polygonal shapes include rounded polygons. The outer diameter of the wire may be, for example, 25 μm or more, 30 μm or more, or 35 μm or more, and may be 125 μm or less, or 100 μm or less.

As shown in Figure 3, the coil 3 preferably has a head portion 3H at its tip. The head portion 3H covers part of the wire to prevent the tip of the wire from coming into direct contact with 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 3. The head portion 3H preferably contains metal or resin.

As shown in Figure 3, the coil 3 is disposed on the distal side of the elongated coil delivery device 4. The distal side of the coil delivery device 4 refers to the distal portion when the coil delivery device 4 is longitudinally divided into a distal portion and a proximal portion. Specifically, as shown in Figure 3, it is preferable that the coil 3 be removably connected to the distal portion 4b of the distal portion of the coil delivery device 4. For example, by deforming the distal portion 4b of the coil delivery device 4 within the lesion, the coil 3 can be detached from the coil delivery device 4 and placed in the lesion. Examples of deformation of the distal portion 4b of the coil delivery device 4 include melting, electrolysis, mechanical disengagement, or a combination of these. Examples of melting and electrolysis include melting or electrolysis of the distal portion 4b of the coil delivery device 4 using electricity or heat. For example, the proximal end of the coil delivery device 4 can be connected to a high-frequency power supply device, electricity is passed through, and Joule heat is generated near the distal portion 4b, thereby melting the distal portion 4b. An example of mechanical disengagement is disengagement of the coil 3 and coil delivery device 4, which are engaged using a hook and loop or the like. Note that the coil 3 may be releasably connected to a portion of the distal end of the coil delivery device 4 other than the distal end portion 4b.

The tip portion 4b of the coil 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 shape of the tip portion 4b of the coil delivery device 4 is preferably cylindrical, rod-like, or a combination of these.

The elongated coil delivery device 4 can move the coil 3 toward both the distal and proximal ends. To use the device, remove each component from the packaging bag 5, pull the coil delivery device 4 toward the proximal end to draw the coil 3 into the first tube 1, and then push the coil delivery device 4 back in, exposing the coil 3 from the distal end 1B of the first tube 1 or from the distal end of another tube distal to the first tube 1, thereby placing the coil 3 within the lesion. The coil delivery device 4 may be a solid elongated body, a tube, or a combination thereof. For example, the solid elongated body is preferably a metal wire. Metal wires are more likely to exhibit electrical 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, which makes it easier to prevent electrical leakage. The coil delivery device 4 may also have multiple solid elongated bodies.

The coil delivery device 4 may contain an X-ray opaque material. A protective layer may be provided on the outer surface of the coil 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 coil delivery device 4 and the first tube 1, etc.

As shown in Figures 2 and 3, at least a portion of the coil delivery tool 4 is disposed in the lumen 1C of the first tube 1. By manipulating the coil delivery tool 4 in this arrangement, the coil 3 can be placed into or pushed out of the first tube 1. As shown in Figure 1, it is preferable that a portion of the coil delivery tool 4 is exposed from the first tube 1. Specifically, it is preferable that a portion of the base end of the coil delivery tool 4 is exposed from the first tube 1. This makes it easier to operate the coil delivery tool 4.

As shown in Figure 3, at least a portion of the coil 3 is exposed from the tip 1B of the first tube 1. In particular, it is preferable that the entire coil 3 is exposed from the tip 1B of the first tube 1. This makes it easier to avoid plastic deformation within the first tube 1.

As shown in FIG. 1, the medical device 91 preferably further includes a second tube 2. Specifically, the medical device 91 preferably further includes a second tube 2 enclosed 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.

As shown in Figure 1, it is preferable that the second tube 2 is 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 using the arrangement shown in Figure 1, for example, a portion of the first tube 1 may be inserted into the second tube 2 from the longitudinal base end 2A of the second tube 2.

It is preferable that at least a portion of the coil 3 is exposed from the tip 2B of the second tube 2. This makes it easier to check the condition of the coil 3 before use, improving safety. It is even more preferable that the entire coil 3 is exposed from the tip 2B of the second tube 2.

The second tube 2 preferably has a through-hole 2H on its outer surface 2S that communicates with the lumen 2C of the second tube 2. When performing gas sterilization such as ethylene oxide gas sterilization, the sterilizing gas can easily penetrate into the second tube 2 through the through-hole 2H, making it easier to sterilize the inside of the second tube 2. The outer surface 2S may have multiple through-holes 2H. When the second tube 2 is divided into three equal parts in the longitudinal direction, and the first, second, and third regions are defined in order from closest to the base end 2A, it is preferable that the second tube 2 has a through-hole 2H on the outer surface 2S of at least the second region. This makes it easier for the sterilizing gas to penetrate into the second tube 2 as a whole.

As shown in FIG. 1, the medical device 91 preferably further includes a tip member 8 that is connected to the tip portion 2b of the second tube 2 and has an inner cavity 8C that communicates with the inner cavity 2C of the second tube 2. It is preferable that at least a portion of the coil 3 is disposed in the inner cavity 8C of the tip member 8. This makes it even easier for the coil 3 to maintain its three-dimensional shape. As shown in FIG. 3, it is preferable that the coil 3 is not in contact with the tip member 8. This makes it even easier for the coil 3 to maintain its three-dimensional shape.

As shown in FIG. 3 , the tip member 8 is flat, and the thickness 8T of the tip member 8 is preferably larger than the outer diameter 2T of the second tube 2. The flat shape of the tip member 8 reduces the bulk of the medical device 91. Furthermore, the thickness 8T of the tip member 8 is larger than the outer diameter 2T of the second tube 2, which allows the lumen 8C of the tip member 8 to be larger, making it easier to avoid contact between the coil 3 and the inner surface of the tip member 8. The thickness 8T of the tip member 8 is preferably 1.1 times or more, more preferably 1.5 times or more, and even more preferably 2.0 times or more the outer diameter 2T of the second tube 2. On the other hand, the thickness 8T of the tip member 8 is preferably 8.0 times or less, more preferably 6.0 times or less, and even more preferably 5.0 times or less the outer diameter 2T of the second tube 2.

As shown in Figure 3, the tip member 8 preferably has a through hole 8H1 that communicates with the inner cavity 8C of the tip member 8. The tip portion 2b of the second tube 2 can be inserted and fixed into the tip member 8 via the through hole 8H1. The tip portion 2b of the second tube 2 is preferably detachably fitted into the through hole 8H1 of the tip member 8, but may also be fixed to the through hole 8H1 of the tip member 8 with an adhesive or the like. On the other hand, the first tube 1 is preferably not connected to the tip member 8. This allows the tip portion 1b of the first tube 1 to be pulled out from the tip member 8.

The tip member 8 preferably contains acrylic resin, polyester resin, polycarbonate resin, polyvinyl chloride resin, or a combination of these. The polyester resin preferably contains polyethylene terephthalate. This improves transparency, making it easier to check the state of the coil 3 inside the tip member 8. The tip member 8 may contain an ultraviolet scattering agent such as titanium dioxide, a coloring agent, etc. to block light. The tip member 8 may also have a moisture absorbent such as silica gel in the part that comes into contact with the lumen 8C. This makes it easier to prevent the drug in the coil 3 from deteriorating.

As shown in Figure 1, the shape of the tip member 8 in plan view is preferably circular, elliptical, polygonal, rounded polygonal, or a combination of these, with circular, elliptical, or rounded polygonal being more preferred, and circular being even more preferred. The closer the shape is to a circle, the easier it is to prevent the tip member 8 from puncturing the packaging bag 5 during transportation, etc.

The diameter of the circumscribing circle of the tip member 8 in a plan view is preferably larger than the outer diameter of the second tube 2. This allows the inner cavity 8C of the tip member 8 to be larger, making it easier to avoid contact between the coil 3 and the inner surface of the tip member 8. The diameter of the circumscribing circle of the tip member 8 in a plan view is preferably 1.1 times or more, more preferably 1.5 times or more, and even more preferably 2.0 times or more the outer diameter of the second tube 2. On the other hand, this magnification is preferably 8.0 times or less, more preferably 6.0 times or less, and even more preferably 5.0 times or less. This makes it easier to store the tip member 8 in the packaging bag 5.

The tip member 8 may consist of one member, or two or more members. For example, the tip member 8 may consist of a housing without an opening, or may have a housing with an opening and a lid that covers the opening.

As shown in Figure 3, the tip member 8 preferably has a leaf spring 8P, and the tip portion 2b of the second tube 2 is fixed to the tip member 8 by the leaf spring 8P. The leaf spring 8P can fix the tip portion 2b of the second tube 2 to the tip member 8 with an appropriate force. The tip portion 2b of the second tube 2 may be detachably fixed to the tip member 8. The leaf spring 8P may contain resin, metal, or a combination of these. The leaf spring 8P may also be made of the same material as the tip member 8 and may be molded integrally with the tip member 8.

As shown in Figure 3, the tip member 8 preferably has a through-hole 8H2 that connects the inner cavity 8C of the tip member 8 to the space inside the packaging bag 5. When performing gas sterilization such as ethylene oxide gas sterilization, the sterilizing gas can easily penetrate into the tip member 8 through the through-hole 8H2, making it easier to sterilize the inside of the tip member 8. The tip member 8 may have multiple through-holes 2H.

As shown in Figure 1, it is preferable that a portion of the first tube 1 is exposed from the longitudinal base end 2A of the second tube 2. This configuration makes it easier to pull out the first tube 1 from the base end 2A of the second tube 2 during use.

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.

The first tube 1 is preferably biocompatible. It is preferable that the first tube 1 contains polyamide resin, polyester resin, polyurethane resin, polyolefin resin, polyvinyl chloride resin, silicone resin, natural rubber, or a combination thereof. These resins may contain elastomers with rubber elasticity. The inner diameter of the first tube 1 need only be long enough to allow the coil 3, which has a three-dimensional shape outside the first tube 1, to contract within the first tube 1. The inner diameter of the first tube 1 is preferably 0.1 to 1.5 mm, and more preferably 0.3 to 1.0 mm.

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 of these. 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. The inner diameter of the second tube 2 is preferably 1.1 to 5.0 mm, and more preferably 1.5 to 4.0 mm.

As shown in Figure 1, the second tube 2 is preferably fixed in its wound shape by a clip 7. The clip 7 preferably has multiple grooves or through-holes into which portions of the second tube 2 can be fitted. It is more preferable that the multiple grooves or through-holes be capable of fitting portions of the connecting member 6, which will be described later.

As shown in FIG. 1, the packaging bag 5 contains at least the coil 3, the coil delivery device 4, and the first tube 1. 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 coil 3, 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 a single sheet and joining the outer edges of the overlapping portions. These outer edges are preferably joined by heat sealing.

The upper sheet preferably includes a resin film, and is preferably made of a resin film. The resin film 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.

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. 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.

As shown in FIG. 5, the medical device 91 preferably has a connecting member 6 configured to connect the first tube 1 to a liquid injection device (not shown), such as a syringe. In FIG. 5, the base end 1a of the first tube 1 is connected to the connecting member 6. The connecting member 6 preferably has an inner lumen 6C that communicates with the inner lumen 1C of the first tube 1. At the time of use, these are removed from the packaging bag 5, and liquid is injected from the liquid injection device into the inner lumen 1C of the first tube 1 through the inner lumen 6C of the connecting member 6, thereby enabling operations such as purging air from the first tube 1 to be performed. The first tube 1 is preferably configured to be indirectly connected to the distal end of the liquid injection device via the connecting member 6, but may also be configured to be directly connected to the distal end of the liquid injection device. In the case of a direct connection, for example, the base end 1a of the first tube 1 may be disposed within the distal end of the liquid injection device, or the distal end of the liquid injection device may be disposed within the base end 1a of the first tube 1.

The connecting member 6 preferably has multiple openings, each of which communicates with the inner cavity 6C of the connecting member 6. Specifically, as shown in FIG. 5, the connecting member 6 preferably has an opening to which the base end 1a of the first tube 1 is connected, and an opening configured to connect to the tip end of a liquid injection device. This allows the above-mentioned communication configuration to be formed. The connecting member 6 preferably also has an opening through which the coil delivery device 4 passes. This allows a portion of the coil delivery device 4 to be positioned within the first tube 1. Furthermore, the connecting member 6 may have an opening configured to connect to a filter for filtration sterilization, instead of an opening configured to connect to the tip end of a liquid injection device. As shown in FIG. 5, the connecting member 6 preferably has a branched structure. This makes it easier to avoid contact between the liquid injection device and other components when connected.

If the tip of the liquid injection device has a threaded portion with a spiral groove or a spiral protrusion, the connecting member 6 preferably has a fitting portion 6G configured to fit into the threaded portion.

As shown in FIG. 5, the base end 1a of the first tube 1 is preferably fixed to the opening of the connecting member 6. The base end of the first tube 1 may be fixed to the opening of the connecting member 6, or the base end of the first tube 1 may be positioned within the lumen 6C of the connecting member 6, with the portion of the base end 1a of the first tube 1 distal to the base end being fixed to the opening of the connecting member 6. Fixing may be achieved by adhesive, welding, fitting, or a combination of these. The base end 1a of the first tube 1 may have a tapered portion whose outer diameter decreases from the base end to the tip. By fixing the connecting member 6 so that this tapered portion is located within the connecting member 6, the base end 1a of the first tube 1 is even less likely to come off the connecting member 6.

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

The liquid supplied into the first tube 1 via the liquid injection device during use preferably contains saline. Physiological saline is suitable for use because it is less harmful to the living body. For example, saline can be supplied to the first tube 1 from a syringe to remove gas from the first tube 1. The sodium chloride content of the saline is preferably 0.5-2.0 w/v%, more preferably 0.6-1.5 w/v%, even more preferably 0.8-1.0 w/v%, and most preferably 0.9 w/v%. In other words, it is most preferable that the saline is a physiological saline solution. This allows for flushing, for example. 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.

The liquid supplied into the first tube 1 via the liquid injection device preferably contains a drug. The drug preferably contains an anticoagulant, an antiplatelet drug, or a mixture of these. Such drugs make it easier to prevent the formation of thrombi in areas other than the aneurysm and the clogging of the catheter.

Preferably, the anticoagulant 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. Preferably, the antiplatelet agent includes an ADP receptor inhibitor, a 5-HT2 receptor inhibitor, a PDE inhibitor, a COX inhibitor, a prostaglandin preparation, or a mixture thereof.

The liquid preferably contains saline and a drug. For example, by containing saline and heparin, the liquid can be used effectively for flushing. It is particularly preferable that the liquid contains saline and heparin.

By delivering the coil 3 to the lesion via the first tube 1, vascular lesions can be treated. The coil 3 may also be delivered to the lesion via a tube other than the first tube 1. The longitudinal length of the first tube 1 is preferably 10 to 100 cm, and more preferably 20 to 60 cm.

Although not shown, the medical device 91 may further have a backing. The backing may have a flap formed by a slit, and the second tube 2 may be fixed to the backing by the flap.

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 and abdominal aneurysms, or other vascular lesions.

The medical device according to the second embodiment will be described below with reference to Figures 6 and 7. Figure 6 is a plan view of the medical device according to the second embodiment. Figure 7 is an enlarged side view of the vicinity of the tip of the second tube in Figure 6.

As shown in Figure 6, the medical device 92 according to the second embodiment comprises a coil 3 containing a drug, a long coil delivery device 4 with the coil 3 disposed at its tip, a first tube 1 with at least a portion of the coil delivery device 4 disposed in its lumen 1C, and a packaging bag 5 containing these. Furthermore, as shown in Figure 7, at least a portion of the coil 3 is exposed from the tip 1B of the first tube 1. This makes it easier for the coil 3 to maintain its three-dimensional shape.

The medical device 91 further includes a second tube 2, and it is preferable that at least a portion of the first tube 1 is disposed in the lumen 2C of the second tube 2. As shown in FIG. 7, it is preferable that the coil 3 is disposed in the lumen 2C of the second tube 2. With this arrangement, the coil 3 is protected by the second tube 2, making it easier for the coil 3 to maintain its three-dimensional shape. As shown in FIG. 7, it is preferable that the coil 3 is not in contact with the second tube 2. This makes it even easier for the coil 3 to maintain its three-dimensional shape.

As shown in Figure 6, it is preferable that no other components be connected to the tip 2b of the second tube 2. This makes it easier for the sterilizing gas to reach the vicinity of the coil 3 during gas sterilization.

The coil 3 is preferably located in an area 1 mm or more and 10 cm or less away from the tip 2B of the second tube 2, and more preferably in an area 2 mm or more and 5 cm or less away. This makes it easier for the second tube 2 to protect the coil 3, and also makes it easier for the sterilizing gas to reach the vicinity of the coil 3 during gas sterilization.

For other configurations of the medical device 92 according to the second embodiment, please refer to the description of the medical device 91 according to the first embodiment.

This application claims the benefit of priority based on Japanese Patent Application No. 2024-048517, filed March 25, 2024. The entire contents of the specification of Japanese Patent Application No. 2024-048517, filed March 25, 2024, are incorporated herein by reference.

DESCRIPTION OF SYMBOLS 1 First tube 1a Base end 1b Distal end 1B Distal end 1C Lumen 2 Second tube 2A Base end 2b Distal end 2B Distal end 2C Lumen 2H Through hole 2S Outer surface 2T Outer diameter of second tube 3 Coil 3H Head portion 4 Coil delivery tool 4b Distal end 5 Packaging bag 5C Space 5E Outer edge 6 Connecting member 6C Lumen 6G Fitting portion 7 Clip 8 Distal end member 8C Lumen 8H1, 8H2 Through hole 8P Leaf spring 8T Thickness of distal end member 91, 92 Medical device

Claims (15)

a coil having a drug;
a long coil delivery tool having the coil disposed at its distal end;
a first tube having at least a portion of the coil delivery tool disposed in an inner lumen thereof;
a packaging bag containing the coil, the coil delivery tool, and the first tube,
A medical device in which at least a portion of the coil is exposed from the tip of the first tube. The medical device according to claim 1, wherein the coil is detachably connected to the distal end of the coil delivery tool. The medical device according to claim 1 or 2, further comprising a second tube, the lumen of which contains at least a portion of the first tube. The medical device according to claim 3, wherein at least a portion of the coil is exposed from the tip of the second tube. The medical device according to claim 3, wherein the coil is disposed in the lumen of the second tube. The catheter further includes a distal end member connected to the distal end of the second tube and having an inner cavity communicating with the inner cavity of the second tube,
The medical device according to claim 3 , wherein at least a portion of the coil is disposed in the lumen of the tip member. The medical device described in claim 6, wherein the tip member is flat and the thickness of the tip member is greater than the outer diameter of the second tube. The medical device according to claim 6, wherein the tip member has a through-hole that communicates with the inner cavity of the tip member and the space within the packaging bag. The tip member has a leaf spring,
The medical device according to claim 6, wherein the distal end of the second tube is fixed to the distal end member by the leaf spring. The medical device according to claim 3, wherein the second tube has a through-hole on its outer surface that communicates with the inner cavity of the second tube. The medical device according to claim 3, wherein the second tube is wound. The medical device according to claim 5, wherein the coil is not in contact with the second tube. The medical device according to claim 6, wherein the coil is not in contact with the tip member. The medical device according to claim 1, wherein the portion of the coil exposed from the tip of the first tube is continuously curved and does not have a straight portion. The medical device according to claim 1, wherein the entire coil is exposed from the tip of the first tube.