WO2023042909A1

WO2023042909A1 - Catheter and embolus pre-loaded catheter

Info

Publication number: WO2023042909A1
Application number: PCT/JP2022/034752
Authority: WO
Inventors: 恵理生野; 亮水田; 秀彬柴田; 将郎川村
Original assignee: テルモ株式会社
Priority date: 2021-09-17
Filing date: 2022-09-16
Publication date: 2023-03-23

Abstract

The purpose of the present invention is to prevent unintentional ejection of an embolus, which is loaded in a catheter, during priming operations. A catheter 20 comprises a loading lumen 22 that is configured to allow loading of an embolus 10 therein, a catheter body 21 that has a distal end including a distal end opening 21a connected to the distal end of the loading lumen, and a distal end member 70 provided at the distal end of the catheter body. The distal end member 70 comprises a restraining part 80 that is configured to be in contact with the distal end of the embolus loaded in the loading lumen and thus restrains the protrusion of the body part, excluding the distal end, of the embolus from the distal end opening, and a flow channel 90 that allows a priming fluid to drain from the distal end of the catheter body. This catheter can allow the discharge of the embolus from the catheter body by (a) removing the distal end member from the catheter body, or (b) allowing the embolus in contact with the restraining part to deform the restraining part to thereby form an embolus outlet through which the embolus can pass.

Description

Catheters and embolic-loaded catheters

The present invention relates to catheters and embolus-loaded catheters.

For aneurysms (aortic aneurysms) that occur in the patient's aorta, there is no drug treatment to prevent the aneurysm from increasing in size or rupture. is done. Conventionally, surgery for aortic aneurysms was mainly performed by artificial blood vessel replacement surgery in which an artificial blood vessel was transplanted through laparotomy or thoracotomy. application is expanding rapidly.

As an example, in stent graft insertion for abdominal aortic aneurysm (AAA), a catheter containing a stent graft at its tip is inserted from a patient's peripheral blood vessel, and the stent graft is deployed and indwelled in the affected area of the aneurysm. Blood flow to the aneurysm may be blocked to prevent rupture of the aneurysm.

Generally, a stent graft used in stent graft insertion includes a "main body" having a substantially Y-shaped bifurcation, and a "main body" attached to the bifurcation and extending to the right iliac artery and the left iliac artery. It has a structure that can assemble two types of members that are attached to each leg.

Therefore, during stent graft insertion, blood leakage from around the stent graft due to insufficient adhesion of the inserted stent graft, backflow of blood from small blood vessels (branch vessels) branching from the aneurysm, etc., can cause blood to enter the aneurysm. A so-called "endoleak", in which flow remains, may occur. In this case, blood flow that has entered the aneurysm exerts pressure on the aneurysm wall, potentially causing the aneurysm to rupture.

Patent Document 1 below discloses a catheter capable of holding a relatively elongated compressed sponge (embolus) in its lumen in order to block residual blood flow in an aortic aneurysm caused by an endoleak, and a catheter and a plunger that pushes the embolus held therein into the blood-filled aneurysm. The sponge used in this device expands as soon as it is exposed to blood, so when it is pushed out into the aneurysm and absorbs the blood in the aneurysm, it expands (swells) and remains in the aneurysm in that state. It blocks blood flow to prevent rupture.

U.S. Pat. No. 9,561,096

In a catheter whose lumen is loaded with an embolus, such as the device disclosed in Patent Document 1, air may exist in the lumen, and when the embolus is ejected into the aneurysm, the air is also included. May be discharged. Air expelled into the aneurysm can flow into the collateral vessels of the aneurysm, causing air embolism. Therefore, the operator performs a priming operation of injecting a priming solution such as physiological saline into the catheter loaded with the embolus to expel the air in the lumen.

However, in the device disclosed in Patent Document 1, when a priming operation is performed with the embolus loaded in the catheter, the embolus may unintentionally pop out of the catheter due to the pressing force (water pressure) of the priming liquid. . A catheter loaded with an embolus has a small diameter because it is used by being inserted into a biological lumen such as a blood vessel. There is also a risk of breakage, and reloading the protruded embolus is not preferable from a sanitary point of view, and there is room for improvement.

At least one embodiment of the present invention has been made in view of the above problems, and an object thereof is to provide a catheter and an embolus-loaded catheter capable of preventing unintended ejection of emboli loaded in the catheter during a priming operation. and

The catheter according to this embodiment includes a loading lumen configured to be able to load an embolus to be inserted and indwelled into an aneurysm in vivo, and a distal end portion including a distal opening communicating with the distal end of the loading lumen. and a tip member provided at the tip of the catheter body, the tip member contacting the tip of the embolus loaded in the loading lumen, a suppressing part configured to suppress protrusion of a main body portion of the embolism other than the distal end from the distal opening of the catheter body; and the suppressing part serves as the distal opening of the main body part of the embolism. a flow path configured to allow the priming liquid, which moves from the proximal side toward the distal side of the loading lumen, to be discharged from the distal end portion of the catheter body in a state in which projection from the portion is suppressed; (a) removing the tip member from the catheter body, or (b) deforming the restraining portion by the embolus being pushed toward the restraining portion so that the embolus containing the flow path is or forming a passable embolic material discharge port so that the embolic material loaded into the loading lumen can be discharged from the catheter body through the distal opening.

In addition, an embolus-loaded catheter according to the present embodiment includes the above-described catheter and the embolus loaded in a loading lumen.

According to at least one embodiment of the present invention, it is possible to prevent unintentional ejection of the embolus loaded in the catheter during the priming operation.

1 is a diagram showing the configuration of a medical instrument set and a delivery system according to a first embodiment of the present invention; FIG. 1 is a diagram showing the configuration of an embolus delivery medical system according to a first embodiment of the present invention; FIG. It is a figure which shows the tip member which concerns on 1st Embodiment of this invention. It is a figure showing the tip side of the catheter concerning a 1st embodiment of the present invention. It is a figure which shows the modification of a tip member. It is a figure which shows the modification of the 1st hole of a tip member. It is a figure which shows the modification of the 1st hole of a tip member. It is a figure which shows the modification of the 1st hole of a tip member. It is a figure which shows the modification of the 1st hole of a tip member. It is a figure which shows the modification of the 1st hole of a tip member. It is a figure which shows the modification of the 1st hole of a tip member. It is a figure which shows the modification of a tip member. 7B is an enlarged cross-sectional view along line 7B-7B of FIG. 7A; FIG. It is sectional drawing which shows the modification of the 1st internal space of a tip member, and a 3rd outlet. It is sectional drawing which shows the modification of the 1st internal space of a tip member, and a 3rd outlet. FIG. 4 is a schematic cross-sectional view showing one form example of the engaging portion of the medical instrument set. 5B is a schematic cross-sectional view showing an engaged state of the engaging portion of FIG. 5A; FIG. FIG. 11 is a partially enlarged view of the vicinity of the handle portion of the delivery pusher; FIG. 11 is a partial enlarged view showing the insertion state of the delivery pusher; FIG. 10 is a diagram showing an operation example of the embolus delivery medical system according to one embodiment of the present invention, showing a state in which the delivery catheter is delivered into the aneurysm. FIG. 10 is an operation example of the embolus delivery medical system according to one embodiment of the present invention, showing a state in which the stent graft is deployed in the aneurysm. FIG. 10 is an operation example of the embolism delivery medical system according to one embodiment of the present invention, showing a state before the embolism-loaded catheter is attached to the delivery catheter. FIG. 10 is a diagram showing an operation example of the embolism delivery medical system according to one embodiment of the present invention, showing a state in which an embolism-loaded catheter is attached to a delivery catheter. FIG. 10 is a diagram showing an operation example of the embolus delivery medical system according to one embodiment of the present invention, showing a state in which the delivery pusher is being inserted into the embolus-loaded catheter. FIG. 10 is an operation example of the embolus delivery medical system according to one embodiment of the present invention, showing a state in which the delivery pusher pushes the embolus into the aneurysm. FIG. 10 is a diagram showing an operation example of the embolization delivery medical system according to one embodiment of the present invention, showing a state in which an embolization-loaded catheter is detached from the delivery catheter. It is a figure which shows the front end side of the catheter which concerns on the modification of 1st Embodiment. It is a figure which shows the tip member which concerns on 2nd Embodiment. FIG. 10 is a diagram showing the distal end side of a catheter according to a second embodiment; It is a schematic sectional drawing which shows the engagement state of the engagement part which concerns on 2nd Embodiment. 13D is a schematic cross-sectional view showing a modification of the engaged state shown in FIG. 13C; FIG. FIG. 10 is a diagram showing the distal end side of a catheter according to a modified example of the second embodiment; It is a schematic sectional drawing which shows the engagement state of the engagement part which concerns on the modification of 2nd Embodiment. FIG. 15B is a diagram showing Modification 1 of the catheter shown in FIG. 15A. 16B is a schematic cross-sectional view showing an engaged state of the engaging portion of the catheter shown in FIG. 16A; FIG. FIG. 14B is a view showing Modification 2 of the catheter shown in FIG. 14A. It is a figure which shows the tip member which concerns on 3rd Embodiment. FIG. 11 is a diagram showing the distal end side of a catheter according to a third embodiment; 18B is a diagram showing a modification of the tip member shown in FIG. 18A. FIG. 19B is a view of the distal end of a catheter with the tip member shown in FIG. 19A attached. FIG. 19C is an enlarged cross-sectional view along line 19C-19C of FIG. 19B; FIG. 19B is a view showing a modification of the tip member shown in FIG. 19A; FIG. 13 is a view showing a case where the tip member according to the third embodiment is applied to the catheter shown in FIG. 12; FIG.

Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiment shown here is an example for embodying the technical idea of the present invention, and does not limit the present invention. In addition, other practicable modes, embodiments, operation techniques, etc. that can be conceived by those skilled in the art without departing from the gist of the present invention are all included in the scope and gist of the present invention, and are described in the scope of claims. included within the scope of the claimed invention and its equivalents.

In addition, the drawings attached to this specification may be represented schematically by appropriately changing the scale, length-to-width ratio, shape, etc. from the actual thing for the convenience of illustration and ease of understanding. and does not limit the interpretation of the present invention.

Further, in this specification, the operation direction of each part constituting the embolus delivery medical system 300 capable of delivering the embolus 10 into the aneurysm is, for example, the delivery direction for delivering the embolus-loaded catheter 20M into the aneurysm. The direction along the axial direction of the catheter 40 and the side on which the embolus 10 is conveyed into the aneurysm is referred to as the "distal side (or distal end)". The side where the catheter is operated (the side where the delivery catheter 40 is removed) is referred to as the "proximal side (or proximal end)". In addition, the “distal end” means a certain axial range including the distal end, and the “basal end” means a certain axial range including the most proximal end.

In addition, in the following explanation, when ordinal numbers such as "first" and "second" are used for explanation, unless otherwise specified, they are used for convenience and do not prescribe any order.

[composition]
A medical instrument set 100, a delivery system 200, and an embolism delivery medical system 300 according to this embodiment will be described.

The medical instrument set 100, the delivery system 200, and the embolus delivery medical system 300 according to the present embodiment are, for example, an abdominal aorta, which is a therapeutic method for preventing rupture of an intravascular aneurysm (for example, an aneurysm). It can be applied in endoleak embolization for stent grafting of aneurysms (AAA). In addition, treatment methods to which the medical device set 100, the delivery system 200, and the embolism delivery medical system 300 according to the present embodiment can be applied are not limited to the above-described endoleak embolization, and can be used to treat rupture of an aneurysm occurring in a blood vessel. Other interventional therapies for prevention are also applicable.

FIG. 1 is a diagram showing the configuration of a medical instrument set 100 and a delivery system 200 according to the first embodiment of the present invention, and FIG. 2 is a diagram showing the configuration of an embolism delivery medical system 300. FIG. 3A to 8B are diagrams showing the configuration of the tip member 70, and FIG. 3A shows only the tip member 70 for convenience of explanation. 3A(A) is a perspective view of the distal end member 70, and FIG. 3A(B) is a plan view seen from the axial direction. 9A to 10B are diagrams showing the connection state of each configuration.

The arrow X attached to the drawing indicates the "axial direction (longitudinal direction)" of the catheter body of the embolus-loaded catheter, the arrow Y indicates the "width direction (depth direction)" of the catheter body, and the arrow Z indicates the The "height direction" of the catheter body is shown.

<Medical instrument set>
The medical instrument set 100 includes an embolus-loaded catheter 20M loaded with the embolus 10 and a delivery pusher 30, as shown in FIG.

<Embolus>
The embolus 10 is indwelled in an aneurysm such as an aneurysm formed in a blood vessel, and expands by absorbing fluid including blood flowing into the aneurysm. The catheter 20 is loaded with the embolus 10, and with the catheter 20M loaded with the embolus attached to the delivery catheter 40, it is pushed out by the delivery pusher 30 and left in the aneurysm.

The embolus 10 is an elongated fibrous linear body (linear body) made of an expandable material (such as a polymer material (water-absorbing gel material)) that expands under physiological conditions when it comes into contact with an aqueous liquid containing blood.

As used herein, "physiological conditions" refer to conditions that have at least one environmental characteristic in or on the body of a mammal (eg, human). Such properties include an isotonic environment, a pH buffered environment, an aqueous environment, a pH near neutrality (about 7), or combinations thereof. In addition, "aqueous liquid" includes, for example, isotonic liquid, water; body fluids of mammals (eg, humans) such as blood, cerebrospinal fluid, plasma, serum, vitreous humor, and urine. The outer diameter of the embolus 10 can be accommodated within the inner diameters of the embolus-loaded catheter 20M and the delivery catheter 40, and can be, for example, substantially the same as the inner diameters of these catheters. Also, the total length of the embolization device 10 is not particularly limited, but may be appropriately determined depending on the size of the aneurysm to be indwelled in consideration of ease of loading and shortening of procedure time.

In addition, the constituent material of the embolization object 10 should be at least a material that expands by absorbing a liquid such as blood and has no (or extremely low) toxicity to the human body even when indwelled in the aneurysm. Not limited. In addition, the embolus 10 may be added with a visualization material that allows confirmation of its location in the living body by a confirmation method such as X-rays, fluorescent X-rays, ultrasonic waves, fluorescent methods, infrared rays, and ultraviolet rays.

<Cather with embolus loaded>
The embolus-loaded catheter 20M includes an elongated catheter body 21, a tip member 70 provided at the distal end of the catheter body 21, a proximal hub 23 provided at the proximal side of the catheter body 21, and one end It comprises a catheter 20 having a flexible tube 24 connected to the proximal side of a proximal hub 23 and having the other end connected to a port 26 of a stopcock 25, and an embolus 10. FIG.

The catheter main body 21 is a tubular member formed with a hole communicating from an opening on the distal end side to an opening on the proximal end side along the axial direction. , and has a distal end including a distal opening 21 a communicating with the distal end of the loading lumen 22 . The length of the catheter main body 21 in the extending direction is defined as appropriate, but it is sufficient that it has a length that can accommodate at least the embolism 10 .

The inner diameter of the loading lumen 22 is designed to be substantially the same as the inner diameter of the sheath lumen 42 of the delivery catheter 40 . This allows the outer diameter of the embolus 10 to be approximately the same as the inner diameter of the embolus-loaded catheter 20M and the delivery catheter 40 .

The catheter 20 is mainly supplied with the embolus 10 loaded in advance. may As a method of loading the embolus 10, the operator can grasp the embolus 10 and insert it from the distal end connecting portion 27 side or the proximal hub 23 side of the catheter 20. FIG.

The tip member 70 arranged on the tip connecting portion 27 side can be removed from the catheter main body 21 . When the tip member 70 is removed from the catheter main body 21 , the catheter main body 21 with the embolus 10 accommodated therein is engaged with the sheath hub 43 of the delivery catheter 40 via the distal connection portion 27 and attached. In this mounted state, the delivery pusher 30 is inserted from the proximal hub 23 to push the loaded embolus 10 toward the delivery catheter 40 .

The constituent material of the embolic-loaded catheter 20M is at least more rigid than the delivery catheter 40, and is a material that provides an appropriate degree of hardness to prevent breakage of the loaded embolus 10 during packaging. If there is, it is not particularly limited. Examples of constituent materials of the catheter body 21 include polyolefins (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, or mixtures of two or more of these), polyolefin elastomers. , Polyolefin crosslinked products, Polyvinyl chloride, Polyamide, Polyamide elastomer, Polyester, Polyester elastomer, Polyurethane, Polyurethane elastomer, Fluoropolymers, Polycarbonate, Polystyrene, Polyacetal, Polyimide, Polyetherimide, Aromatic polyetherketone, etc. Resin materials such as materials or mixtures thereof, shape memory alloys, metal materials such as stainless steel, tantalum, titanium, platinum, gold, and tungsten can be preferably used.

It should be noted that the catheter main body 21 only needs to be more rigid than the sheath 41 from the viewpoint of preventing breakage of the embolus 10. Therefore, the material itself should be hard, and if the same material as the sheath 41 is used, it will be thicker than the sheath 41. It is good also as a form which thickens thickness and is hard to kink. In the case of a form with variable wall thickness, the outer diameter of the catheter main body 21 is larger than the outer diameter of the sheath 41, but the catheter 20M loaded with the embolus is attached to the delivery catheter 40 via the engaging portion 60. Therefore, it is not a problem.

The proximal end hub 23 has an insertion passage 23a (lumen) that allows the tube 24 to communicate with the loading lumen 22 of the catheter body 21. It is an intermediate member for circulating through the catheter main body 21. Proximal hub 23 functions as an injection hub capable of injecting priming fluid into loading lumen 22 of embolized catheter 20M. The embolus 10 loaded into the loading lumen 22 is pushed out toward the delivery catheter 40 by inserting the delivery pusher 30 into the loading lumen 22 via the insertion passage 23 a of the proximal hub 23 .

The constituent material of the base end hub 23 is not particularly limited as long as it is a hard material such as hard resin. As an example of the constituent material of the base end hub 23, polyolefins such as polyethylene and polypropylene, polyamide, polycarbonate, polystyrene, and the like can be suitably used.

A hemostatic valve (not shown) is attached to the inside of the proximal end side of the proximal end hub 23 . The hemostasis valve may use a substantially elliptical film-like (disc-like) valve body made of, for example, an elastic member such as silicone rubber, latex rubber, butyl rubber, or isoprene rubber.

The tube 24 has one end connected to the proximal side of the proximal hub 23 and the other end connected to the port 26 of the stopcock 25 . The tube 24 is a conduit through which liquid such as physiological saline discharged from a priming syringe (not shown) connected to the port 26 flows.

The tube 24 is not particularly limited as long as it is a resin material having flexibility in consideration of operability. As an example of the constituent material of the tube 24, polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers, polyesters such as polyethylene terephthalate, polystyrene, and polyvinyl chloride can be suitably used.

The stopcock 25 communicates with the insertion passage 23 a of the proximal hub 23 and the loading lumen 22 of the catheter body 21 via the tube 24 . The proximal end of the tube 24 is connected to the port 26 of the stopcock 25, and a priming syringe for priming the loading lumen 22 of the catheter body 21 can also be connected. In this embodiment, the stopcock 25 employs a three-way stopcock. However, the stopcock 25 is not limited to a three-way stopcock, and other forms (for example, a two-way stopcock, a multi-way stopcock having four or more ports, etc.) may be employed.

As shown in FIG. 3A , the tip member 70 includes a main body portion 71 arranged to intersect the axial direction of the catheter main body 21 , and an outer peripheral surface (side surface) of the distal end portion of the catheter main body 21 extending from the main body portion 71 . ) 21S.

Further, the tip member 70 has a suppressing portion 80 and a flow path 90 as shown in FIG. 3B.

As shown in FIG. 3B, the suppressing portion 80 is formed in the main body portion 71 and prevents the embolic object 10 from moving to the tip of the loading lumen 22 due to the water pressure generated when the operator performs the priming operation. is configured so that the tip of the Therefore, the suppressing part 80 is loaded into the loading lumen 22 when the embolus 10 moves toward the distal end opening 21a of the catheter body 21 due to the hydraulic pressure generated during the priming operation of filling the loading lumen 22 with the priming solution. It is possible to prevent the main body portion of the embolization object 10 excluding the distal end from protruding from the distal end opening 21 a of the catheter body 21 .

As shown in FIGS. 3A and 3B, the flow path 90 has a first discharge port composed of a first hole 91 formed in the body portion 71 and a plurality of second holes 92 formed in the extension portion 72 . and a first internal space 93 formed between the main body portion 71 and the catheter main body 21, and are in communication from the distal end side to the proximal end side of the distal end member 70.

As shown in FIG. 3A, the first hole portion 91 has a substantially circular shape and is formed substantially at the center of the main body portion 71 . As shown in FIG. 3A(B), the size of the first hole 91 is configured to be smaller than the size of the embolization object 10 when viewed from a direction intersecting the axial direction of the catheter body 21. there is 3A(A), each of the second holes 92 has a substantially circular shape and is formed along the circumferential direction of the catheter main body 21. As shown in FIG. 3B, the first internal space 93 is formed by the extension 72 and communicates with the loading lumen 22 and the

holes

91 and 92. As shown in FIG. Therefore, when the operator performs a priming operation, the flow path 90 allows the priming liquid that moves from the proximal side to the distal side of the loading lumen 22 to flow through the first discharge port (first hole 91) and/or It can be discharged from the first discharge port (second hole 92 ), and can prevent the embolus 10 from protruding from the tip opening 21 a of the catheter body 21 .

Therefore, the embolus-loaded catheter 20M to which the tip member 70 is attached can prevent the embolus 10 loaded in the catheter 20 from unintentionally popping out during the priming operation.

Also, the tip member 70 can be removed from the catheter body 21 as described above. Therefore, when the tip member 70 is removed from the catheter body 21 , the embolus 10 loaded in the loading lumen 22 can protrude from the tip opening 21 a of the catheter body 21 . Therefore, the embolus-loaded catheter 20M from which the tip member 70 is removed can discharge the embolus 10 loaded in the loading lumen 22 from the catheter body 21 through the tip opening 21a.

The constituent material of the tip member 70 is not particularly limited, and a resin material including a rubber material, a metal material, or the like can be suitably used. Also, the tip member 70 can be made of water-soluble polysaccharides having film-forming properties, such as starch and pullulan. In this case, since the tip member 70 can be configured so as to prevent the embolus 10 from popping out during the priming operation and to be dissolved by the priming liquid in contact with it after the priming operation, the operator can perform the priming operation. There is no need to remove the tip member 70 after finishing. Also, the tip member 70 can be made of a biodegradable plastic such as polylactic acid. In this case, the tip member 70 can be configured so as to decompose and disappear in the body even if it accidentally enters the body.

Note that the configuration of the tip member 70 can be changed as appropriate, as described below.

For example, the shape of the distal end side of the distal end member 70 is not particularly limited. As shown in FIG. 4, the tip member 70A may further include projections 73. As shown in FIG. By configuring in this way, the operator can move the distal end member 70A while gripping the protrusion 73 . Therefore, the operator can easily remove the tip member 70A from the catheter body 21 (or attach the tip member 70A to the catheter body 21).

Also, the shape of the first hole 91 is not particularly limited. The shape of the first hole may be a circle (see FIG. 3A) including a substantially perfect circle, an ellipse, or a polygon. For example, the first hole 91B of the tip member 70B is rectangular (see FIG. 5A), the first hole 91C of the tip member 70C is cross-shaped (see FIG. 5B), and the first hole 91D of the tip member 70D is oblique. Square (see FIG. 5C), the first hole 91E of the tip member 70E can be star-polygonal (star-octagon, see FIG. 5D).

Also, the shape of the second hole 92 is not particularly limited. The shape of the second hole may be a circle (see FIG. 3A) including a substantially perfect circle or an ellipse, or may be rectangular.

Also, the number of first hole portions 91 and second hole portions 92 is not particularly limited as long as it is one or more. Moreover, when forming several 1st holes (or several 2nd holes) in a tip member, arrangement|positioning of each 1st hole (or each 2nd hole) is not specifically limited. For example, as shown in FIG. 6A, the tip member 70F may have a plurality of first holes 91F, and the first holes 91F may be radially arranged. Further, as shown in FIG. 6B, the tip member 70G may have a plurality of first holes 91G, and the first holes 91G may be arranged in a grid pattern. Further, when a plurality of second holes are formed in the extending portion of the tip member, each second hole may be formed along the axial direction and/or the circumferential direction of the catheter main body 21. They may be arranged regularly with respect to the part, or may be arranged irregularly (not shown).

Further, although the tip member 70 has been described as having the first discharge port (first hole 91) and the second discharge port (second hole 92), at least the first discharge port and the second discharge port are provided. Any one of the outlets may be provided.

Also, the form of connection between the tip member 70 and the catheter body 21 is not particularly limited. For example, the tip member 70 and the catheter body 21 may be connected by screwing, or may be connected by pressing the tip member 70 into the catheter body 21 . The value of the distance d (see FIG. 3B) between the body portion 71 of the tip member 70 and the tip opening 21a of the catheter body 21 is not particularly limited. The range of the extension portion 72 connected to can be changed as appropriate. When the tip member 70 has a second outlet (second hole 92), the body portion 71 of the tip member 70 and the tip opening of the catheter body 21 are arranged to discharge the priming liquid from the second outlet. It is necessary to secure a certain distance (that is, distance d) from the portion 21a. However, when the tip member 70 does not have the second outlet (the second hole 92) and has only the first outlet (the first hole 91), it is not necessary to secure the distance d. . Therefore, the main body portion 71 of the tip member 70 may be in contact with the tip opening 21 a of the catheter body 21 when the tip member 70 and the catheter body 21 are connected.

In addition, the tip member 70 includes an internal space in which the flow path 90 is formed between the extension portion 72 and the outer peripheral surface (side surface) 21S of the distal end portion of the catheter body 21 and communicates with the first internal space 93; It may be arranged to further include an outlet port communicating with the space.

For example, as shown in FIG. 7A, the channel 90H of the tip member 70H includes a first interior space 93H formed between the body portion 71H and the catheter body 21 and communicating with the loading lumen 22;
A plurality of second internal spaces 94 formed between the extension portion 72H and the side surface 21S of the distal end portion of the catheter body 21 and communicating with the first internal space 93H, and a third internal space 94 communicating with each of the second internal spaces 94. It includes an outlet 95 . The tip member 70H is configured to be attachable (or detachable) to the catheter body 21, and when the tip member 70H is attached to the catheter body 21, the extension 72H of the tip member 70H is at least partially connected to the catheter body 21. be. The shape of the first internal space 93H of the tip member 70H (cross-sectional size when the first internal space 93H is viewed from the axial direction) is triangular, and the tip member 70H may be provided with three third discharge ports 95. (See Figure 7B).

The shape of the first internal space is not particularly limited, and the number of third discharge ports is defined by the shape of the first internal space. For example, as shown in FIG. 8A, when the shape of the first internal space of the tip member 70I is a cross when viewed from the direction intersecting the axial direction of the catheter body 21, the tip member 70I has eight A third outlet 95I may be provided.

Further, as shown in FIG. 8B, when the shape of the first internal space of the tip member 70J is an octagonal star when viewed from the direction intersecting the axial direction of the catheter body 21, the tip member 70J Eight third outlets 95J can be provided. The shape of the first internal space may be other star polygons such as a pentagonal star.

<Connection State of Catheter 20M Loaded with Embolism and Delivery Catheter 40>
As shown in FIGS. 9A and 9B, the distal end side of the catheter 20 is provided with a distal end connecting portion 27 (corresponding to a connecting portion) that is connected to the sheath hub 43 of the delivery catheter 40 . The distal connecting portion 27 is provided with a second engaging portion 28 that engages with a first engaging portion 48 provided on the proximal end side of the sheath hub 43 .

In the medical device set 100 according to the present embodiment, the first engaging portion 48 and the second engaging portion 28 are the engaging portion 60 for maintaining the connection state between the catheter 20M loaded with the embolus and the delivery catheter 40. configure.

9A and 9B show examples of the form of the engaging portion 60. FIG. In the engaging portion 60, the first engaging portion 48 functions as a female portion and the second engaging portion 28 functions as a male portion.

The engagement portion 60 may be configured to fit the embolus-loaded catheter 20M over the delivery catheter 40, as shown in FIG. 9B. In this embodiment, the first engaging portion 48 is a groove portion 48a provided in the outer peripheral surface of the sheath hub 43 on the proximal end side along the circumferential direction, and the second engaging portion 28 is the outer peripheral surface of the distal end portion of the catheter main body 21. It is provided as a separate skirt member fixed on the surface, and has a plurality of engaging claws 28a provided so as to cover at least part of the outer circumference of the distal end portion of the catheter main body 21 . As shown in FIG. 5B, the engaging portion 60 is fitted with the groove portion 48a that forms the first engaging portion 48 so that the engaging claw 28a of the second engaging portion 28 is fitted with the catheter 20M loaded with the embolus. Keep delivery catheter 40 connected. By connecting the embolus-loaded catheter 20M and the delivery catheter 40, the loading lumen 22 and the sheath lumen 42 communicate with each other.

Note that the engagement portion 60 is not limited to the fitting configuration shown in FIGS. Other connection configurations, such as formula, can also be employed. The engaging portion 60 is configured to maintain the attached state of the catheter 20M loaded with the embolic material and the delivery catheter 40, and prevents the two from being detached during the procedure. However, the embolus-loaded catheter 20M and the delivery catheter 40 do not necessarily have to be engaged via the engaging portion 60. FIG. For example, the state in which the distal end connecting portion 27 is inserted into the sheath hub 43 may be the state in which the catheter 20M loaded with the embolus and the delivery catheter 40 are attached.

As shown in FIG. 9B, the inner diameter of the loading lumen 22 and the inner diameter of the sheath lumen 42 are designed to be substantially the same, and the outer diameter of the embolus 10 is also designed accordingly. can be made thicker. As a result, in endoleak embolization, the number of embolus 10 to be inserted can be reduced, and as a result, the procedure time can be shortened. In addition, since the inner diameters of the loading lumen 22 and the sheath lumen 42 are substantially the same, when the catheter 20M loaded with the embolus and the delivery catheter 40 are connected by the engaging portion 60, the tip opening portion 27b and the communicating tip portion 43b are connected. The level difference (clearance) with the opening on the end side can be made infinitely zero. Therefore, when the pusher body 31 of the delivery pusher 30 is inserted from the loading lumen 22 to the sheath lumen 42, the embolus 10 smoothly moves between the embolus-loaded catheter 20M and the delivery catheter 40. can be done.

The distal end connection portion 27 has an insertion portion 27a that is inserted into a communication enlarged diameter portion 43c provided inside the sheath hub 43 when the catheter 20M loaded with the embolus and the delivery catheter 40 are in a connected state. . The insertion portion 27a is inserted into the sheath hub 43 so that the loading lumen 22 and the sheath lumen 42 are aligned in the axial direction when the catheter 20M loaded with the embolus and the delivery catheter 40 are connected. As a result, the embolus 10 is pushed out from the loading lumen 22 through the sheath hub 43 to the sheath lumen 42 without being exposed to the outside.

In addition, the insertion portion 27a has a distal end abutment portion that abuts the inner surface of the tapered portion 43d provided in the communication enlarged diameter portion 43c on the distal end side thereof when the catheter 20M loaded with the embolic material and the delivery catheter 40 are connected. It has in opening 27b. When the inserting portion 27a is inserted into the communicating enlarged diameter portion 43c, the leading end contact portion abuts against the tapered portion 43d, so that the loading lumen 22 and the sheath lumen 42 include the space of the communicating enlarged diameter portion 43c. It is communicated so as not to intersect with other spaces. Therefore, when the embolus 10 is pushed out from the embolus-loaded catheter 20M into the delivery catheter 40, the embolus 10 is prevented from being damaged (bent or crushed on the distal end side) due to striking against the inner wall surface of the sheath hub 43, and Misinsertion into other spaces within 43 (such as erroneous entry into tube 44 connected to sheath hub 43) is prevented, and delivery to sheath lumen 42 is ensured.

<Delivery pusher>
The pusher for delivery 30 is an elongated rod-like member inserted through the proximal hub 23 to push out the embolus 10 accommodated in the catheter body 21 and deliver it through the see lumen 42 of the delivery catheter 40 into the aneurysm. It is a member. The delivery pusher 30 includes a rod-shaped pusher body 31 and a handle portion 32 provided on the proximal end side of the pusher body 31 and held by the operator when delivering the embolus 10 into the aneurysm.

When the delivery pusher 30 is operated in a predetermined state while the handle portion 32 is gripped by the operator in a state where the catheter 20M loaded with the embolus is attached to the delivery catheter 40, the emboli loaded in the loading lumen 22 is pushed. The article 10 is pushed through the sheath lumen 42 of the delivery catheter 40 and into the aneurysm. Specifically, the delivery pusher 30 is operated to push out the embolus-loaded catheter 20M and the delivery catheter 40 along the axial direction, thereby pushing the embolus 10 loaded into the embolus-loaded catheter 20M to the outside ( into the aneurysm).

The body length of the pusher body 31 of the delivery pusher 30 is the length of the delivery catheter 40 from the proximal end of the insertion passage 23a of the proximal hub 23 in the mounted state in which the catheter 20M loaded with the embolus is mounted on the delivery catheter 40. It is longer than the distance up to the distal opening 41a of the sheath 41 (the distal opening communicating with the sheath lumen 42). Therefore, if the delivery pusher 30 is inserted from the proximal end hub 23 in a state where the catheter 20M loaded with the embolus and the delivery catheter 40 are attached, the emboli loaded in the loading lumen 22 can be pushed out once. The object 10 can be passed through the tip opening 27b→sheath hub 43→sheath lumen 42 in order and pushed out into the aneurysm.

As shown in FIG. 10A, the handle portion 32 has a substantially mushroom shape having a large-diameter head portion 32a on the distal end side and a small-diameter handle portion 32b extending toward the base end side of the large-diameter head portion 32a. The outer diameter dimension of the large-diameter head portion 32 a , which is the maximum outer diameter of the handle portion 32 , is designed to be larger than the inner diameter dimension of the insertion passage 23 a of the base end hub 23 . As a result, as shown in FIG. 10B, when the delivery pusher 30 is inserted into the embolus-loaded catheter 20M, the large-diameter umbrella portion 32a is not inserted into the insertion passage 23a of the proximal hub 23. can limit the insertion length of In addition, since the handle portion 32 does not enter the proximal hub 23 due to the large-diameter head portion 32a, when the delivery pusher 30 finishes pushing out the embolus 10, the catheter 20M loaded with the embolus is removed. Along with this, it is easy to pull out the inserted state at the same time, and the detachment operation becomes simple. The delivery pusher 30 may be withdrawn from the embolus-loaded catheter 20M prior to the withdrawal operation of the embolus-loaded catheter 20M.

The handle portion 32 can also be configured so that the large-diameter head portion 32a can be fitted to the proximal side of the proximal hub 23 when the catheter 20M is inserted into the embolized material-loaded catheter 20M. With such a configuration, when the catheter 20M loaded with the embolus is removed, the delivery pusher 30 can be reliably pulled out from the catheter 20M loaded with the embolus without coming off.

The constituent material of the pusher main body 31 is not particularly limited as long as it is a material that provides appropriate hardness and flexibility that allow the embolization object 10 to be transported. Examples of materials constituting the pusher body 31 include polyolefins (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, or mixtures of two or more of these), polyolefin elastomers. , polyolefin crosslinked products, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluorine resins such as ETFE, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, aromatic polyether ketone, etc. or a resin material such as a mixture thereof, a metal material such as a shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, and tungsten.

<Delivery system>
Next, the delivery system 200 according to this embodiment will be described. As shown in FIG. 1, the delivery system 200 according to the present embodiment includes, in addition to the medical device set 100, a delivery catheter 40 to which the embolus-loaded catheter 20M can be attached and detached while being indwelled in a biological lumen. I have.

<Delivery catheter>
The delivery catheter 40 can also utilize, for example, an existing catheter that can be left in a body lumen. Therefore, in the delivery system 200 according to the present embodiment, the medical device set 100 and the delivery catheter 40 can be sold as a set and supplied to the market, but even if only the medical device set 100 is sold and supplied to the market , an existing catheter can be used as the delivery catheter 40 to function as the delivery system 200 .

The delivery catheter 40 includes a sheath 41 made of an elongated tubular member in which a hole (sheath lumen 42) communicating from an opening on the distal end side to an opening on the proximal end side is formed along the axial direction. It is left in the lumen and functions as an introduction channel for delivering the embolus 10 into the aneurysm. A main body 51 of an insertion assisting member 50, which will be described later, can be inserted through the sheath 41 over its entire length. Therefore, the axial length of the sheath 41 is set at least shorter than the main body 51 of the insertion assisting member 50 .

The inner diameter of the sheath lumen 42 is designed to be substantially the same as the inner diameter of the loading lumen 22 . As a result, the embolus 10 can be smoothly moved from the loading lumen 22 to the sheath lumen 42 while the catheter 20</b>M loaded with the embolus is connected to the delivery catheter 40 by the distal end connecting portion 27 .

The constituent material of the sheath 41 is not particularly limited as long as it is flexible and rigid enough to follow the curved shape of the body lumen such as meandering and bending. Examples of materials constituting the sheath 41 include polyolefins (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, or mixtures of two or more thereof), polyolefin elastomers, Polymer materials such as crosslinked polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, aromatic polyetherketone, etc. , or a resin material such as a mixture thereof can be suitably used.

The delivery catheter 40 includes a sheath hub 43 connected to the proximal end of the sheath 41, and a flexible tube 44 having one end connected to the proximal end of the sheath hub 43 and the other end connected to a stopcock 45. Prepare.

The sheath hub 43 is provided with a communication passage 43a that communicates between the sheath lumen 42 and the tube 44 and between the loading lumen 22 and the sheath lumen 42. It is an intermediate member for circulating through the sheath 41 through the embolus-loaded catheter 20M and guiding the embolus 10 pushed out from the embolus-loaded catheter 20M into the sheath lumen 42. The insertion assisting member 50 is inserted through the sheath hub 43 when the delivery catheter 40 is left in the biological lumen.

As for the constituent material of the sheath hub 43, the same materials as those exemplified as the constituent materials of the base end hub 23 can be used.

The sheath hub 43 is connected to the distal end connecting portion 27 of the catheter 20M loaded with the embolus. In the connected state of the sheath hub 43 and the distal connection portion 27, the loading lumen 22 and the sheath lumen 42 are aligned in the axial direction. As a result, the embolus 10 pushed out from the catheter body 21 is prevented from being damaged (bent or crushed on the distal end side) due to contact with the inner wall surface of the sheath hub 43 .

The tube 44 has one end connected to the proximal end side of the sheath hub 43 and the other end connected to the port 46 of the stopcock 45 . The tube 44 is a conduit through which liquid such as physiological saline discharged from a priming syringe (not shown) connected to the port 46 flows. It should be noted that the same materials as those exemplified as the constituent materials of the tube 24 described above can be used as the constituent material of the tube 44 .

The stopcock 45 communicates with the communicating passage 43 a of the sheath hub 43 and the sheath lumen 42 of the sheath 41 via the tube 44 . A port 46 of the stopcock 45 is connected to the proximal end of the tube 44, a priming syringe for priming the sheath lumen 42 of the sheath 41, and a liquid injection syringe for injecting a contrast agent or a drug. can also In this embodiment, the stopcock 45 employs a three-way stopcock. However, the stopcock 45 is not limited to the three-way stopcock, and other forms (for example, a two-way stopcock, a multi-way stopcock having four or more ports, etc.) may be employed.

A hemostatic valve 47 is attached to the inside of the sheath hub 43 on the proximal end side. The hemostasis valve may use a substantially elliptical film-like (disc-like) valve body made of, for example, an elastic member such as silicone rubber, latex rubber, butyl rubber, or isoprene rubber.

Here, an example of dimensions of each device constituting the delivery system 200 according to this embodiment will be described. It should be noted that the numerical values shown below are only examples, and the present invention is not limited to these.

In the delivery system 200 according to this embodiment, the delivery catheter 40 is a catheter having an outer diameter of 5 Fr (inner diameter of 1.5 mm), and the applied surgical method is endoleak embolization for stent graft insertion of abdominal aortic aneurysm (AAA). In the case of surgery, the outer diameter of the embolus 10 is 0.4 to 1.5 mm (preferably about 1.3 mm), and the inner diameter of the catheter 20M loaded with the embolus is 1.0 to 1.0 mm, which is equivalent to the inner diameter of the delivery catheter 40. It can be 1.8 mm (preferably about 1.5 mm). The length of the catheter body 21 of the catheter 20M loaded with the embolus is 30 to 105 cm (preferably about 42 cm), the length of the sheath 41 of the delivery catheter 40 is 39 to 90 cm (preferably about 70 cm), and the delivery pusher The body length of the pusher body 31 of 30 can be 79 to 205 cm (preferably about 119 cm). The total length of the embolus 10 is appropriately determined depending on the size of the aneurysm, but should be in the range of 10 to 100 cm (preferably about 40 cm) from the viewpoint of ease of loading into the catheter 20M loaded with the embolus and shortening of the procedure time. can be done.

<Embolitic Delivery Medical System>
Next, the configuration of the embolism delivery medical system 300 according to this embodiment will be described. As shown in FIG. 2, the embolism delivery medical system 300 according to this embodiment includes, in addition to the delivery system 200, an insertion assisting member 50 for delivering the delivery catheter 40 into the body lumen.

<Auxiliary insertion member>
The insertion assisting member 50 is formed with a guide wire lumen 52 that is inserted from the distal end side to the proximal end side along the axial direction of the main body 51, and the delivery catheter 40 is inserted along the guide wire previously inserted into the biological lumen. It is an auxiliary tool for assisting the insertion when delivering the aneurysm into the aneurysm.

The insertion assisting member 50 is inserted and assembled into the delivery catheter 40 in order to prevent bending or the like when the delivery catheter 40 is inserted into the biological lumen. Also, the guidewire lumen 52 has a smaller inner diameter than the sheath lumen 42 of the delivery catheter 40 . Therefore, when the delivery catheter 40 is delivered into the aneurysm, axial deviation of the delivery catheter 40 with respect to the guide wire can be reduced, making delivery easier.

The constituent material of the insertion assisting member 50 is not particularly limited as long as it is harder and more flexible than the delivery catheter 40 . Examples of constituent materials of the insertion assisting member 50 include polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine resins such as ETFE, PEEK (polyetheretherketone), and resin materials such as polyimide. Metal materials such as memory alloys, stainless steel, tantalum, titanium, platinum, gold, and tungsten can be preferably used.

[motion]
Next, the operation of the embolism delivery medical system 300 according to this embodiment will be described with appropriate reference to FIGS. 11A to 11G.

The following description is an operation example when the embolus delivery medical system 300 is applied to endoleak embolization for stent graft insertion of an abdominal aortic aneurysm (AAA). uses a substantially circular shape. In FIGS. 11C to 11G, "A" indicates inside the aneurysm, "V" indicates inside the blood vessel, and "O" indicates outside the body, so that the arrangement position of each device of the embolization delivery medical system 300 can be systematically grasped. expressed in

First, as a preoperative preparation step, as shown in FIG. 11A, the operator removes the sheath 41 of the delivery catheter 40 into which the insertion assisting member 50 is inserted from the limb of the patient serving as the puncture site through an introducer (for example, FIG. 11A). (member indicated by a two-dot chain line)), and insert the tip opening 41a of the delivery catheter 40 to the abdominal aortic aneurysm (hereinafter simply referred to as “aneurysm”). have it delivered. Then, when the tip opening 41a is delivered into the aneurysm, the operator withdraws the insertion assisting member 50. As shown in FIG. Note that the operator may deliver the delivery catheter 40 to the aneurysm-affected area by using a guide wire inserted into the aneurysm in advance without using the insertion assisting member 50 . Also, the operator performs a priming operation on the delivery catheter 40 before introducing the delivery catheter 40 into the biological lumen.

Next, as shown in FIG. 11B, the operator inserts the catheter (stent graft device) in which the stent graft SG is compressed and inserted through the introducer into the biological lumen, and uses the guide wire previously inserted into the aneurysm. to the site of the aneurysm. After that, the stent graft SG is deployed from the catheter at the affected area and left in place. As a result, as shown in FIG. 11B, the delivery catheter 40 is placed between the leg of the stent graft SG and the vessel wall, and the distal end of the delivery catheter 40 is placed between the stent graft SG and the vessel wall of the aneurysm. That is, it is inserted into the aneurysm and left in the living body lumen with the distal end opening 41a positioned within the aneurysm.

Next, as shown in FIG. 11C, an embolus-loaded catheter 20M loaded with the embolus 10 is prepared. FIG. 11C shows the embolus-loaded catheter 20M before it is attached to the delivery catheter 40. FIG.

Before attaching the embolus-loaded catheter 20M to the delivery catheter 40, the operator performs a priming operation on the embolus-loaded catheter 20M. In the priming operation, the priming liquid is injected from the port 26, flows through the loading lumen 22, and then is discharged from the outlets of the tip member 70. As shown in FIG. Further, the distal end side of the embolus 10 is configured to abut against the suppressing portion 80 of the distal end member 70 when it moves to the distal end of the loading lumen 22 due to the water pressure generated when the operator performs the priming operation. Therefore, the tip member 70 can prevent the main body portion of the embolus 10 excluding the tip portion from protruding from the tip opening 21 a of the catheter body 21 . Therefore, the embolus-loaded catheter 20M to which the tip member 70 is attached can be prevented from unintentionally popping out during the priming operation.

When the priming operation of the catheter 20M loaded with the embolus is completed, the tip member 70 is removed from the catheter main body 21. Then, as shown in FIG. 11D, the operator attaches the distal end connecting portion 27 of the catheter 20M loaded with the embolus to the proximal end of the sheath hub 43 of the delivery catheter 40. As shown in FIG. At this time, the axial center of the loading lumen 22 is aligned with the axial center of the see lumen 42 .

Next, as shown in FIG. 11E, the operator inserts the distal end of the pusher main body 31 from the proximal side of the proximal hub 23 while gripping the handle portion 32 . The distal end of the delivery pusher 30 inserted from the proximal hub 23 abuts the proximal end of the embolus 10 loaded in the embolus-loaded catheter 20M, and the operator pushes out the embolus 10 for delivery. Push and move through the sheath lumen 42 of the catheter 40 .

Then, as shown in FIG. 11F, the operator pushes out the delivery pusher 30 inserted from the proximal end hub 23 to push out the embolus 10 from the sheath lumen 42 into the aneurysm. After that, the operator withdraws the empty embolus-loaded catheter 20M together with the delivery pusher 30 from the delivery catheter 40, as shown in FIG. 11G. Delivery pusher 30 can be removed from delivery catheter 40 while inserted into embolus-loaded catheter 20M. This completes the first insertion operation of the embolization object 10 into the aneurysm. In the insertion operation, the delivery pusher 30 may be withdrawn from the embolus-loaded catheter 20M prior to the withdrawal operation of the embolus-loaded catheter 20M.

In endoleak embolization, a series of embolus placement operations shown in FIGS. 11C to 11G are repeated until the required amount of embolus 10 is loaded into the aneurysm. The required amount of the embolization material 10 is calculated by subtracting the volume of the stent graft SG when deployed in the aneurysm from the aneurysm volume calculated based on the patient's CT data.

When the required amount of embolization material 10 is placed in the aneurysm, the operator pulls out the delivery catheter 40 from the aneurysm and the body lumen. At this time, with the catheter 20M loaded with the embolus attached to the delivery catheter 40 and the delivery pusher 30 inserted into the delivery catheter 40, the delivery catheter 40 is pulled out from the aneurysm and the biological lumen. good too. Alternatively, the delivery pusher 30 may be withdrawn from the delivery catheter 40 while the embolus-loaded catheter 20M is withdrawn from the delivery catheter 40 before the delivery catheter 40 is withdrawn from the aneurysm and the body lumen. Also, before the delivery catheter 40 is withdrawn from the aneurysm and the biological lumen, the delivery pusher 30 is withdrawn from the delivery catheter 40 and the embolus-loaded catheter 20M, and then the embolus-loaded catheter 20M is pulled from the delivery catheter 40. can be left out. In any case, the introducer is left in the body lumen for additional expansion of the stent graft SG by the balloon after placement of the embolus 10, imaging operation, and the like.

After that, the embolus 10 placed in the aneurysm contacts with fluid such as blood in the aneurysm and gradually swells. It is buried and the aneurysm is occluded. This prevents the aneurysm from rupturing.

It should be noted that the above-described embodiment can be modified to have the following configuration.

In addition, the following modifications (or embodiments) can be arbitrarily combined within the scope of the present invention. In the modified examples (or embodiments) described below, constituent elements having the same functions as those of the above-described embodiment are denoted by the same reference numerals, and detailed descriptions thereof are omitted. may be similar to the embodiments described above.

(Modified example of the first embodiment)
FIG. 12 is a diagram showing configurations of a tip member 70K and a catheter main body 521 according to a modification of the first embodiment.

In the modified example of the first embodiment, the tip member 70K is configured separately from the catheter main body 521, and is configured to be attachable to or detachable from the catheter main body 521.

Further, the catheter body 521 passes through the side wall of the catheter body 521 in the vicinity of the tip opening 521a, and when the tip member 70K is attached to the catheter 520, the proximal end is closer than the extension 72K of the tip member 70K. It has a through hole 521b located on the side.

At least part of the through-hole 521b is positioned closer to the proximal side than the extended portion 72K of the tip member 70K, and the flow path 90K of the tip member 70K communicates with at least part of the through-hole 521b. Therefore, the embolus-loaded catheter 520M to which the tip member 70K is attached can prevent the embolus 10 loaded in the loading lumen (not shown) from unintentionally popping out during the priming operation.

In addition, since the tip member 70K can be removed from the catheter main body 521, the embolus loaded in the loading lumen protrudes from the tip opening 521a of the catheter main body 21 when the tip member 70K is removed from the catheter main body 521. can do. Therefore, the embolus-loaded catheter 520M from which the tip member 70 is removed can discharge the embolus 10 loaded into the loading lumen from the catheter body 521 through the tip opening 521a.

In the first embodiment, the tip member 70 has at least one of the first outlet (first hole 91) and the second outlet (second hole 92). However, when the tip member is attached to the catheter 520M loaded with the embolus, there is no need to provide the tip member with a hole for discharging the priming liquid. Therefore, the tip member 70K does not have to have the first discharge port (first hole) and the second discharge port (second hole).

Also, the number of through-holes 521b is not particularly limited.

(Second embodiment)
In the first embodiment, the distal end of the catheter body 21 and the proximal end of the delivery catheter 40 are connected with the distal end member 70 removed from the catheter body 21. However, the configuration is as follows. can also

13A, 13B, and 13C are diagrams for explaining the configuration of the tip member 670 according to the second embodiment, and FIG. 13A shows only the tip member 670 for convenience of explanation. 13A(A) is a perspective view of the distal end member 670, and FIG. 13A(B) is a plan view seen from the axial direction. FIG. 13A(B) shows the position of the tip opening 21a of the catheter body 21 with respect to the first hole 691 when the tip member 670 is attached to the catheter body 21 by a two-dot chain line. 10 positions are indicated by dashed lines.

In this embodiment, the tip member 670 is configured separately from the catheter main body 21 . In addition, as shown in FIG. 13C, a second engaging portion 628 is provided on the distal end side of the catheter 620, and when the distal end member 670 is attached to the catheter 20, the distal end portion of the catheter main body 21 and the delivery device 628 are connected to each other. The proximal end of catheter 40 is connected. The skirt member of the second engaging portion 628 is formed longer than the second engaging portion 28 .

As shown in FIGS. 13A (A) and (B), the tip member 670 includes a main body portion 671 arranged to intersect the axial direction of the catheter main body 21, and a main body portion 671 extending from the main body portion 671. An extending portion 672 arranged to cover the side surface 21S of the distal end portion and a plurality of cut portions 691a extending from the first hole portion 691 are provided.

13A, the tip member 670 has a suppressing portion 680 and a channel 690. The suppressing portion 680 is defined in the body portion 671 by a notch 691a, and the cross-sectional size of the channel 690 is It has a defining flap portion 681 . A proximal end face 681S of the flap portion 681 is arranged to contact the distal end opening 21a of the catheter main body 21, as shown in FIG. 13B. Therefore, in the present embodiment, the flow path 690 does not include the first internal space, but consists of the first hole 691 and the notch 691a. The flow path 690 may include the first internal space by arranging the flap portion 681 so that the proximal end surface 681S does not come into contact with the distal end opening 21a of the catheter body 21 .

The flap portion 681 abuts the tip portion of the embolic object 10 when the tip portion of the embolic object 10 loaded in the loading lumen 22 moves to the tip portion of the loading lumen 22 due to the water pressure generated during priming. It is configured to deform when an external force stronger than water pressure is applied to the base end surface 681S of 681 to form an embolus outlet including the first hole 691 . Therefore, the embolus-loaded catheter 620M to which the tip member 670 is attached can prevent the embolus 10 loaded in the catheter 620 from unintentionally popping out during the priming operation, and the water pressure generated during the priming operation can be reduced. When a strong external force is applied, the embolus 10 loaded into the loading lumen 22 can be ejected from the catheter body 21 through the tip opening 21a.

13B, the distal end member 670 abuts against the sheath hub 43 when the distal end portion of the catheter main body 21 is inserted into the communication passage 43a of the sheath hub 43, thereby causing the flap portion 681 to extend from the catheter main body 21. The axis of the catheter body 21 extends from a first position L1 located distally of the distal opening 21a to a second position L2 where the flap portion 681 is located proximally of the distal opening 21a of the catheter body 21. is configured to be movable along the

When the tip member 670 moves from the first position L1 to the second position L2 (see FIGS. 13A and 13B), the distal end portion of the catheter body 21 exerts an external force on the proximal end surface 681S of the flap portion 681 to remove the embolus. A discharge port is formed, and the distal end opening 21 a of the catheter body 21 passes through the embolus discharge port and protrudes toward the distal end of the restraining portion 680 . Therefore, the operator does not remove the tip member 670 from the catheter 620, but places the tip member 670 between the engaging portion on the catheter 620 side and the sheath hub 43. 40 can be connected. In addition, since it is not necessary to remove the tip member 670 from the catheter 620, it is possible to prevent the tip member 670 from being accidentally placed on the surgical field or the like.

The number of cuts 691a is not particularly limited.

Also, the method of connecting the distal end portion of the catheter body 21 and the proximal end portion of the delivery catheter 40 is not particularly limited as long as the distal end portion of the catheter body 21 can be inserted into the communicating passage 43 a of the sheath hub 43 . When the distal end portion of the catheter main body 21 is attached to the proximal end portion of the delivery catheter 40, the distal end member 670 moved to the second position L2 is arranged on the proximal end side of the communicating passage 43a of the sheath hub 43. Each part may be configured, and each part may be configured such that the distal end member 670 is disposed on the distal end side (sheath 41 side) of the communicating passage 43 a of the sheath hub 43 . For example, when the valve body 43e of the sheath hub 43A is changed into a shape that allows the tip member 670 to pass through, the operator places the tip member 670 inside the sheath hub 43A and inserts the tip portion of the catheter main body 21 of the catheter 20 into the delivery tube. The proximal end of the catheter 40A can be connected (see FIG. 14).

(Modification of Second Embodiment)
Moreover, the above-described second embodiment can be modified to have the following configuration.

15A and 15B are diagrams for explaining the configuration of a tip member 670A according to a modification of the second embodiment.

As shown in FIG. 15A, the tip member 670A according to the modification of the second embodiment is provided with a second engaging portion 628A, and the tip member 670A is attached to the delivery catheter 40 while the catheter 620 is attached. is connected to the proximal end of the

The tip member 670A has a main body portion 671A and an extension portion 672A. A tapered portion 683 is provided that defines at least a portion of the space 696 .

In addition, as shown in FIG. 15A, the tip member 670A has a suppressing portion 680A and a flow path 690A. The suppressing portion 680A is formed in the tapered portion 683, and the minimum diameter d2 of the third internal space 696 (the length extending in the direction orthogonal to the axial direction of the catheter main body 621) gradually decreases toward the distal end of the main body portion 671A. is configured as

Further, as shown in FIG. 15A, a step is provided on the distal end side of the catheter main body 621 . The tip member 670A abuts against the sheath hub 43 when the tip of the catheter body 621 is inserted into the communication passage 43a of the sheath hub 43, so that the restraining portion 680A is arranged on the tip side of the tip opening 621a of the catheter body 621. The flap portion 681 is configured to be movable along the axis of the catheter body 621 from the first position L3 where the flap portion 681 is located on the proximal end side of the distal end opening 621a of the catheter body 621. there is

Therefore, the distal end member 670A is configured such that the distal end portion of the embolus 10 loaded in the loading lumen 622 comes into contact with the suppressing portion 680A due to the water pressure generated during priming. Further, when an external force in the distal direction stronger than the water pressure applied to the tapered portion 683 is applied to the suppressing portion 680A, the distal end member 670A is deformed so as to expand the minimum diameter d2 of the flow path 690A and the first hole portion 691A. and a third interior space 696 can be formed.

Therefore, the embolus-loaded catheter 620MA to which the tip member 670A is attached can prevent the embolus 10 loaded in the catheter 20 from unintentionally popping out during the priming operation, and the external force stronger than the water pressure generated during the priming operation. is applied, the embolus 10 loaded into the loading lumen 622 can be discharged from the catheter body 621 through the tip opening 621a. Further, the operator can engage the second engaging portion 628 with the first engaging portion 48 of the sheath hub 43 in a state where only the tip member 670A is arranged inside the sheath hub 43 without removing the tip member 670A from the catheter 621. By joining, the loading lumen 622 and the sheath lumen 42 can be communicated (see FIG. 15B).

Note that the configuration of the tip member 670A can be modified in various ways. For example, a tip member 670B, which is a modification of the tip member 670A, has a body portion 671B and an extension portion 672B, as shown in FIG. 16A. It has a third internal space 696B that communicates with the tip opening 621a, and a tapered portion 683B that defines at least part of the third internal space 696B. Further, the tip member 670B has a suppressing portion 680B and a flow path 690B, and the suppressing portion 680B extends toward the tip of the main body portion 671B in a third direction.
It is configured such that the minimum diameter d3 of the internal space 696B gradually decreases. The tip member 670B is provided with a second engaging portion 628B, but differs from the tip member 670A in that the second engaging portion 628B is provided closer to the proximal side than the tapered portion 683B. The operator can connect the distal end of the catheter body 621 and the proximal end of the delivery catheter 40 without removing the distal end member 670B from the catheter 621 of the catheter 620MB loaded with the embolus. can connect the distal end of the catheter main body 621 and the proximal end of the delivery catheter 40 while the distal end of the distal end member 670B is arranged between the engaging portion of the distal end member 670B and the sheath hub 43. (See Figure 16B). The method of connecting the distal end portion of the catheter body 621 and the proximal end portion of the delivery catheter 40 is not particularly limited as long as the distal end portion of the catheter body 621 can be inserted into the communicating passage 43 a of the sheath hub 43 . When the distal end portion of the catheter main body 621 is attached to the proximal end portion of the delivery catheter 40, each portion is arranged so that the distal end member 670B moved to the second position is arranged on the proximal end side of the communicating passage 43a of the sheath hub 43. , and each part may be configured so that the tip member 670B is arranged on the tip side (sheath 41 side) of the communicating passage 43a of the sheath hub 43. As shown in FIG. For example, if the valve body of the sheath hub is changed into a shape that allows the tip member 670B to pass therethrough, the operator can move the distal end of the catheter main body of the catheter and the proximal end of the delivery catheter while the tip member 670B is placed inside the sheath hub. parts can be connected.

Further, the tip member 670A may be provided integrally with the catheter 620. For example, a tapered portion 683C, which is a modified example of the tapered portion 683, is provided integrally with the distal end portion of the catheter main body 621C of the catheter 620MC loaded with the embolic material, as shown in FIG. According to the embolus-loaded catheter 620MC configured in this way, it is possible to prevent the embolus 10 loaded in the catheter 620C from unintentionally popping out during the priming operation, and to apply an external force stronger than the water pressure generated during the priming operation. When this is done, the embolus 10 loaded into the loading lumen 622C can be discharged from the catheter body 621B via the tapered portion 683C.

(Third embodiment)
In the embodiment described above, the tip member (for example, the tip member 70) includes a body portion (body portion 71) and an extension portion that extends from the body portion and is arranged to cover the side surface of the tip portion of the catheter body 21. (Extension portion 72) has been described, but it can also be configured as follows.

18A and 18B are diagrams for explaining the configuration of the tip member 770 according to the third embodiment, and FIG. 18A shows only the tip member 770 for convenience of explanation.

In this embodiment, the tip member 770 is configured separately from the catheter main body 21, and in a state in which the tip member 770 is removed from the catheter main body 21, the distal end portion of the catheter main body 21 and the proximal end portion of the delivery catheter 40 are separated from each other. is connected.

As shown in FIG. 18A, the tip member 770 extends from a main body portion 771 (corresponding to a “second main body portion”) arranged so as to intersect the axial direction of the catheter main body 21, and the main body portion 771, It has an extension 772 (corresponding to a “second extension”) that is at least partially inserted into the loading lumen 22 . Tip member 770 also includes a notch 774 formed in extension 772, as shown in FIG. 18A.

Further, the tip member 770 has a suppressing portion 780 and a flow path 790 as shown in FIG. 18B.

The suppressing portion 780 is formed on the extending portion 772 and is configured to contact the distal end portion of the embolization object 10 when it is moved to the distal end of the loading lumen 22 by the water pressure generated when the operator performs the priming operation. there is

Channels 790 are formed between one or more fourth internal spaces 797 formed between extension 772 and catheter body 21 and between body portion 771 and catheter body 21, as shown in FIG. 18B. and includes a fifth interior space 798 communicating with each of the fourth interior spaces 797 and a fifth outlet 799 communicating with the fifth interior space 798 . The fourth internal space 797, the fifth internal space 798, and the fifth discharge port 799 are notches 774 that communicate the loading lumen 22 with the outside when the tip member 770 is attached to the catheter body 21. , and the catheter main body 21 .

Therefore, the embolus-loaded catheter 720M to which the tip member 770 is attached can prevent the embolus 10 loaded in the catheter 20 from unintentionally popping out during the priming operation.

In addition, since the tip member 770 can be removed from the catheter body 21 , the embolus 10 loaded in the loading lumen 22 is removed from the tip opening 21 a of the catheter body 21 when the tip member 770 is removed from the catheter body 21 . can protrude from Therefore, the embolus-loaded catheter 720M from which the tip member 770 is removed can discharge the embolus 10 loaded in the loading lumen 22 from the catheter body 21 through the tip opening 21a.

The shape of the extension portion 772 (cross-sectional size when the extension portion 772 is viewed from the axial direction) is determined so long as the fourth internal space 797 can be formed between the extension portion 772 and the catheter body 21. , is not particularly limited. For example, as the cross-sectional shape of the extension portion 772, a figure such as a circle including a substantially perfect circle or an ellipse, a polygon, a cross, an orthorhombic, and a star-shaped polygon can be appropriately adopted.

Also, the tip member 770 may further include a protrusion. As shown in FIGS. 19A and 19B, a tip member 770A according to a modification of the tip member 770 includes a main body portion 771A having a protrusion 773 and an extension portion 772A. Further, the main body portion 771A and the extension portion 772A are flat. Therefore, the operator can move the tip member 770A while gripping the protrusion 773, and remove the tip member 770A from the catheter body 21 of the catheter 720MA loaded with the embolus (or attach the tip member 70A to the catheter body 21). Operation can be easily performed. Further, the tip member 770A has a suppressing portion 780A and a flow path 790A. The suppressing portion 780A is formed on the main body portion 771A, and is configured to abut against the distal end portion of the embolization object 10 when it is moved to the distal end of the loading lumen 22 by the water pressure generated when the operator performs the priming operation. . Channel 790A includes a plurality of fourth internal spaces 797A formed between extension 772A and catheter body 21, as shown in Figures 19B and 19C. Since the fourth internal space 797A communicates with the outside, it can also function as a fifth outlet. The operator can use the flat-shaped extending portion 772A to fit the inner surface of the catheter body 21 while securing the flow path, and the tip member 770 does not fall off due to the hydraulic pressure generated when performing the priming operation. can be prevented.

The shape of the extending portion 772A is not particularly limited as long as it is a shape that can fit into the inner surface of the catheter main body 21 while ensuring the flow path. For example, as shown in FIG. 20, an extending portion 772B of a tip member 770B according to a modification of the tip member 770A has a tapered shape such that its outer diameter d4 gradually decreases toward the proximal end. The extending portion does not need to fit with the inner surface of the catheter body 21 from the proximal end to the distal end, and the extending portion 772B of the tip member 770B fits with the inner surface of the catheter body 21 only on the distal end side. . With this configuration, the operator can easily insert the tip member 770B into the catheter main body 21 of the catheter 720MB loaded with the embolus.

Also, as shown in FIG. 21, the tip member 770 can be applied to an embolus-loaded catheter 520M having a through hole 521b. In addition, in FIG. 21, the tip member 770 is shaded for convenience of explanation. When the tip member 770 is attached to the embolus-loaded catheter 520M, the priming liquid can be discharged through the through hole 521b without securing a flow path between the extension portion 772 and the catheter main body 521. Therefore, the shape of the extension portion 772 (cross-sectional size when the extension portion 772 is viewed from the axial direction) can be made substantially the same as the inner diameter of the catheter body 521 .

[Effect]
As described above, the catheter 20 according to the present embodiment communicates with the loading lumen 22 configured so that the embolus 10 to be inserted and indwelled in the aneurysm in the living body can be loaded, and the distal end of the loading lumen 22. and a tip member 70 provided at the tip of the catheter body 21, the tip member 70 being the embolus loaded in the loading lumen 22. a suppressing part 80 configured to suppress projection of the body portion of the embolization object 10 excluding the tip part from the tip opening 21a of the catheter body 21 by coming into contact with the tip part of the object 10; The priming solution moving from the proximal side to the distal side of the loading lumen 22 can be discharged from the distal end of the catheter body 21 in a state in which the body portion of the embolization object 10 is restrained from protruding from the distal opening 21a. and a flow path 90 configured as follows. In addition, the catheter 20 can be formed by (a) removing the tip member 70 from the catheter main body 21 or (b) deforming the restricting portion 80 by the embolus 10 pushed out toward the restricting portion 80 to form an embolus including the flow path 90 . The embolus 10 loaded into the loading lumen 22 can be discharged from the catheter body 21 through the tip opening 21a.

According to such a configuration, the catheter 20 to which the tip member 70 is attached receives the priming liquid that moves through the loading lumen 22 from the proximal side toward the distal side when the operator performs a priming operation. The embolus 10 ejected from the distal end of the main body 21 and loaded into the loading lumen 22 can be retained in the loading lumen 22 . Therefore, the catheter 20 to which the tip member 70 is attached can prevent the embolus 10 loaded in the catheter 20 from unintentionally popping out during the priming operation.

Further, the tip member 70 includes a main body portion 71 arranged to intersect the axial direction of the catheter main body 21 and an extension member extending from the main body portion 71 and arranged so as to cover the side surface of the distal end portion of the catheter main body 21 . The suppressing portion 80 is formed in the main body portion 71 and is configured such that the distal end portion of the embolus 10 loaded in the loading lumen 22 comes into contact with water pressure generated during the priming operation.

According to such a configuration, the catheter 20 to which the tip member 70 is attached can prevent the distal side of the embolization material 10 loaded in the catheter 20 from unintentionally popping out during the priming operation.

Further, the flow path 90 includes a first outlet composed of one or more first holes 91 formed in the body portion 71 .

According to such a configuration, when the operator performs the priming operation, the priming liquid that moves through the loading lumen 22 from the proximal side toward the distal side is discharged from the first discharge port at the distal end portion of the catheter main body 21. In addition, it is possible to prevent the embolus 10 from protruding from the tip opening 21 a of the catheter body 21 .

Also, the size of the first hole 91 is characterized by being smaller than the size of the embolus 10 when viewed from the direction intersecting the axial direction of the catheter body 21 .

According to such a configuration, the flow path 90 can prevent the embolus 10 from protruding from the tip opening 21a of the catheter body 21 when the operator performs the priming operation.

In addition, the flow path 90 includes a second discharge port consisting of one or more second holes 92 formed in the extension portion 72, and the second discharge port extends in the axial direction and/or the circumferential direction of the catheter body 21. formed along

With such a configuration, the flow path 90 can more efficiently discharge the priming liquid from the catheter body 21 through the second hole 92 .

Further, the flow path 90H of the tip member 70H is formed between the main body portion 71H and the catheter main body 21, and includes a first internal space 93H communicating with the loading lumen 22, an extension portion 72H, and the distal end portion of the catheter main body 21. and one or more second internal spaces 94 communicating with the first internal space 93H, and a third outlet 95 communicating with each of the second internal spaces 94 .

With such a configuration, the flow path 90 can more efficiently discharge the priming liquid from the catheter body 21 via the third discharge port 95 .

Also, the tip member 70 is configured separately from the catheter main body 21 and configured to be attachable or detachable.

According to such a configuration, when the tip member 70 is removed, the catheter body 21 can be engaged with the sheath hub 43 of the delivery catheter 40 via the tip connection portion 27 with the embolus 10 accommodated therein. can.

In addition, the catheter 620 deforms the suppressing portion 680 that defines the cross-sectional size of the flow path 690 when the embolus 10 abuts on the suppressing portion 680 to form an embolus discharge port including the flow path 690, thereby opening the distal end. The embolus 10 loaded into the loading lumen 22 can be discharged from the catheter body 21 through the portion 21a. The tip member 670 also includes one or more cutouts 691a extending from the first hole 676, and the restraining portion 680 is defined in the body portion 671 by the cutouts 691a to reduce the cross-sectional size of the flow path 690. The flap portion 681 is provided with a regulating flap portion 681, and the distal end portion of the embolus 10 loaded in the loading lumen 22 is brought into contact with the water pressure generated during the priming operation, and the water pressure to the proximal end surface 681S of the flap portion 681 is lower than the water pressure. It is configured to be deformed by application of a strong external force to form an embolism outlet including the first hole 676 .

With such a configuration, the tip member 670 can prevent the embolus 10 loaded in the catheter 620 from unintentionally popping out during the priming operation, and can be applied with an external force stronger than the water pressure generated during the priming operation. At that time, the embolus 10 loaded into the loading lumen 22 can be discharged from the catheter body 21 through the tip opening 21a.

Moreover, at least a portion of the distal end side of the catheter main body 21 is configured to be insertable into the communicating passage 43 a of the sheath hub 43 provided at the proximal end portion of the delivery catheter 40 . Further, the tip member 670 contacts the sheath hub 43 when the tip of the catheter body 21 is inserted into the communicating passage 43a of the sheath hub 43, so that the flap portion 681 is positioned on the tip side of the tip opening 21a of the catheter body 21. The flap portion 681 is movable along the axis of the catheter body 21 from a first position L1 located at the top of the catheter body 21 to a second position L2 located proximal to the distal end opening 21a of the catheter body 21. When the distal end member 670 moves from the first position L1 to the second position L2, the distal end portion of the catheter body 21 exerts an external force on the proximal end surface 681S of the flap portion 681, thereby forming an embolus discharge port. The distal end opening 21a of the catheter main body 21 is configured to protrude toward the distal end side of the restraining portion 680 by passing through the embolus discharge port.

According to such a configuration, when the priming operation is completed, the operator can move the tip member 670 from the first position L1 to the second position L2 without removing the tip member 670 from the catheter 20. A distal end of the catheter body 21 and a proximal end of the delivery catheter 40 can be connected. In addition, since it is not necessary to remove the tip member 670 from the catheter 620, it is possible to prevent the tip member 670 from being accidentally placed on the surgical field or the like.

In addition, the catheter 20 deforms the suppressing portion 680A that defines the cross-sectional size of the flow path 690A when the embolus 10 abuts on the suppressing portion 680A to form an embolus discharge port including the flow path 690A. The embolus 10 loaded in the loading lumen 622 can be discharged from the catheter main body 621 via 621a. In addition, the body portion 671A of the tip member 670A has a third internal space 696 that communicates between the first hole portion 691A and the tip opening 621a of the catheter body 621, and a taper that defines at least part of the third internal space 696. The suppressing portion 680A is formed in the tapered portion 683, and the tapered portion 683 extends toward the distal end of the body portion 671A to the maximum in the direction perpendicular to the axial direction of the catheter body 21 in the third internal space 696. Since the small diameter d2 is configured to gradually decrease, the distal end of the embolus 10 loaded in the loading lumen 622 is configured to abut against the water pressure generated during the priming operation, and the water pressure is stronger than the water pressure. is applied to the tapered portion 683, the tapered portion 683 is deformed so as to expand the minimum diameter d2 of the third internal space 696, and forms an embolus outlet including the first hole portion 691A and the third internal space 696. configured to

With such a configuration, the tip member 670A can prevent the embolus 10 loaded in the catheter 20 from unintentionally popping out during the priming operation, and when an external force stronger than the water pressure generated during the priming operation is applied, , the embolus 10 loaded into the loading lumen 622 can be discharged from the catheter body 621 through the tip opening 621a.

At least part of the catheter main body 621 and/or the tip member 670A is configured to be insertable into the communicating passage 43a of the sheath hub 43 provided at the proximal end of the delivery catheter 40. Further, when at least a portion of the distal end side of the catheter main body 621 is inserted into the communicating passage 43a of the sheath hub 43, the distal end member 670A abuts against the sheath hub 43 so that the tapered portion 683 extends toward the distal end opening 621a of the catheter main body 621. from a first position located distally of the catheter body 621 to a second position wherein the tapered portion 683 is located proximally of the distal opening 621a of the catheter body 621 along the axis of the catheter body 621. , the distal end portion of the catheter body 621 forms an embolus discharge port by applying an external force to the tapered portion 683 when the distal end member 670A moves from the first position L3 to the second position L4, and the catheter body 621 A tip opening 621a of 621 is configured to pass through the embolus discharge port and protrude to the tip side of the suppressing portion 680A.

According to such a configuration, when the priming operation is completed, the operator can move the tip member 670A from the first position L3 to the second position L4 without removing the tip member 670A from the catheter 20. The distal end of catheter body 621 and the proximal end of delivery catheter 40 can be connected. In addition, since it is not necessary to remove the tip member 670A from the catheter 620, it is possible to prevent the tip member 670A from being accidentally placed on the surgical field or the like.

In addition, the tip member (for example, the tip member 670) is configured separately from the catheter main body 21 and attached to the catheter main body 21.

According to such a configuration, when the priming operation is completed, the operator connects the distal end portion of the catheter main body 21 and the proximal end portion of the delivery catheter 40 while the distal end member 670 is attached to the catheter 20. be able to.

In addition, the catheter body 521 has one or more through-holes 521b penetrating the side wall of the catheter body 521 in the vicinity of the tip opening 521a, and at least part of the through-holes 521b is an extension of the tip member 70K. At least a part of the through-hole 521b, which is located on the proximal side of 73K, communicates with the flow path 90K of the tip member 70K.

With such a configuration, the catheter main body 521 can discharge the priming liquid through the through-hole 521b, and the tip member 70K prevents the embolus 10 loaded in the loading lumen from unintentionally popping out during the priming operation. can be prevented.

Further, the tip member 770 includes a main body portion 771 (second main body portion) arranged so as to intersect the axial direction of the catheter main body 21, and a main body portion 771 extending from the main body portion 771 and at least partially inserted into the loading lumen 22. and an extension portion 772 (second extension portion) which is formed separately from the catheter main body 21 and is configured to be removable from the distal end portion of the catheter main body 21 . In addition, the suppressing portion 780 is formed in the extending portion 772, and is configured so that the distal end side of the embolus 10 loaded in the loading lumen 22 comes into contact with water pressure generated during the priming operation, and the flow path 790 extends. One or more fourth internal spaces 797 formed between the portion 772 and the catheter body 21, and a fifth internal space 797 formed between the body portion 771 and the catheter body 21 and communicating with each of the fourth internal spaces 797. The catheter body 21 includes an interior space 798 and a fifth outlet 799 in communication with the fifth interior space 798 such that the catheter body 21 exits the loading lumen 22 through the tip opening 21a when the tip member 770 is removed from the catheter body 21. The loaded embolic material 10 can be ejected.

According to such a configuration, the tip member 770 can prevent the embolus 10 loaded in the catheter 20 from unintentionally popping out during the priming operation.

In addition, the tip member 770 includes a main body portion 771 (corresponding to a “third main body portion”) arranged so as to intersect the axial direction of the catheter main body 521, and a main body portion 771 extending from the main body portion 771 to provide at least a loading lumen. and a partially inserted extension portion 772 (corresponding to a “third extension portion”), which is configured separately from the catheter main body 521 and configured to be removable from the distal end portion of the catheter main body 521. The suppressing portion 780 is formed in the extending portion 772 and configured so that the distal end side of the embolus 10 loaded in the loading lumen comes into contact with the water pressure generated during the priming operation. In the vicinity of the opening 521a, there are one or more through holes 521b that pass through the side wall of the catheter body 521 and are positioned closer to the proximal side than the third extension. At least part of the through-hole 521b is located on the proximal side of the extending portion 772, and at least part of the through-hole 521b communicates with the flow path 790. When detached from the main body 521, the embolus 10 loaded into the loading lumen can be discharged through the tip opening 521a.

According to such a configuration, the priming liquid can be discharged through the through hole 521b without securing a flow path between the extension portion 772 and the catheter main body 521.

In addition, the embolus-loaded catheter includes the catheter described above and the embolus 10 loaded in the loading lumen.

According to such a configuration, when the operator performs a priming operation on the catheter to which the tip member is attached, the priming liquid that moves through the loading lumen from the proximal side toward the distal side is applied to the tip of the catheter body. The embolus 10 ejected from the section and loaded into the loading lumen can be retained in the loading lumen. Therefore, the catheter to which the tip member is attached can prevent the embolus 10 loaded in the catheter from unintentionally popping out during the priming operation.

This application is based on Japanese Patent Application No. 2021-152293 filed on September 17, 2021, the disclosure of which is incorporated by reference in its entirety.

10 emboli,
20 catheter,
20M embolus loaded catheter,
21 catheter body,
22 loading lumens,
70 tip member,
71 main body,
72 extension,
80 suppressor,
90 flow path,
91 first hole (first outlet),
92 second hole (second outlet),
93 first interior space,
100 medical instrument set,
200 delivery system,
300 embolic delivery medical system,
X-axis direction,
Y width direction,
Z height direction.

Claims

a catheter body having a loading lumen capable of being loaded with an embolus to be inserted and left in an aneurysm in vivo; and a distal end portion including a distal opening communicating with the distal end of the loading lumen;
a tip member provided at the tip of the catheter body,
The tip member is
By contacting the distal end of the embolus loaded in the loading lumen, the projection of the main body portion of the embolus excluding the distal end from the distal opening of the catheter body is suppressed. a restraining portion;
In a state in which the suppressing portion suppresses the protrusion of the main body portion of the embolus from the distal end opening, the priming liquid moving through the loading lumen from the proximal side to the distal side is suppressed by the catheter body. and a flow path that can be discharged from the tip of
(a) removing the tip member from the catheter main body; or (b) deforming the restraining portion by the embolus pushed out toward the restraining portion so that the embolus including the flow path can pass through. forming a substance discharge port, so that the occlusive substance loaded into the loading lumen can be discharged from the catheter body through the tip opening.
The tip member includes a body portion arranged to intersect the axial direction of the catheter body, and an extension extending from the body portion and arranged to cover a side surface of the tip portion of the catheter body. and
2. The suppressing portion according to claim 1, wherein the suppressing portion is formed in the main body portion and configured such that the distal end portion of the embolus loaded into the loading lumen is brought into contact by the water pressure generated during the priming operation. catheter.
The catheter according to claim 2, wherein the flow path includes a first outlet consisting of one or more first holes formed in the main body.
The catheter according to claim 3, wherein the size of the first hole is smaller than the size of the embolus when viewed from a direction intersecting the axial direction of the catheter body.
the flow path includes a second outlet formed of one or more second holes formed in the extension,
3. The catheter of claim 2, wherein the second outlet is formed along the axial direction and/or circumferential direction of the catheter body.
The flow path is formed between the main body portion and the catheter body, and is between a first internal space communicating with the loading lumen and between the extension portion and the outer peripheral surface of the distal end portion of the catheter body. 3. The catheter of claim 2, comprising one or more second internal spaces formed in and communicating with said first internal spaces, and a third outlet communicating with each of said second internal spaces.
The catheter according to any one of claims 2 to 5, wherein the tip member is configured separately from the catheter body and configured to be attachable or detachable.
The embolus in contact with the suppressing portion deforms the suppressing portion that defines the cross-sectional size of the flow path to form the embolus discharge port including the flow path, thereby the embolus loaded in the loading lumen can be discharged from the catheter body by
the tip member includes one or more cuts extending from the first hole;
the suppressing portion includes a flap portion defined in the body portion by the cut portion and defining the cross-sectional size of the flow path;
The distal end of the embolus loaded in the loading lumen is brought into contact with the flap portion by the water pressure generated during the priming operation. 4. The catheter of claim 3, configured to deform to form the embolic outlet including the first aperture.
At least a portion of the distal end side of the catheter body is insertable into a communicating passage of a sheath hub provided at the proximal end portion of the delivery catheter,
The tip member abuts against the sheath hub when the tip portion of the catheter body is inserted into the communication passage of the sheath hub, thereby causing the flap portion to move toward the tip side of the tip opening of the catheter body. movable along the axis of the catheter body from a first positioned position to a second position in which the flap portion is positioned proximal to the distal opening of the catheter body;
When the distal end member moves from the first position to the second position, the distal end portion of the catheter body exerts the external force on the proximal end surface of the flap portion, thereby causing the embolus discharge port to move from the first position to the second position. is formed and
9. The catheter of claim 8, wherein the distal opening of the catheter body is configured to protrude distally of the restricting portion by passing through the embolus outlet.
The embolus in contact with the suppressing portion deforms the suppressing portion that defines the cross-sectional size of the flow path to form the embolus discharge port including the flow path, thereby the embolus loaded in the loading lumen can be discharged from the catheter body by
The body portion of the tip member includes a third internal space communicating between the first hole portion and the tip opening of the catheter body, and a tapered portion defining at least a portion of the third internal space; further comprising
The suppressing portion is formed on the tapered portion, and is configured such that the tapered portion gradually decreases the minimum diameter of the third internal space in the direction perpendicular to the axial direction of the catheter body toward the distal end of the body portion. As a result, the distal end of the embolus loaded in the loading lumen is configured to abut against the water pressure generated during the priming operation, and an external force stronger than the water pressure is applied to the distal direction. It is configured to deform so as to expand the minimum diameter of the third internal space by being imparted to the tapered portion to form the embolus discharge port including the first hole and the third internal space. 4. The catheter of claim 3, wherein:
at least part of the catheter body and/or the tip member is insertable into a communicating passage of a sheath hub provided at the proximal end of the delivery catheter;
The tip member abuts against the sheath hub when at least a portion of the distal end side of the catheter body is inserted into the communication passage of the sheath hub, thereby causing the tapered portion to extend from the tip opening of the catheter body. movable along the axis of the catheter body from a first position disposed distally to a second position wherein the tapered portion is disposed proximally of the distal opening of the catheter body; ,
the distal end portion of the catheter body forms the embolus discharge port by applying the external force to the tapered portion when the distal end member moves from the first position to the second position; 11. The catheter according to claim 10, wherein the distal end opening of the catheter body passes through the embolus discharge port and protrudes distally of the restricting portion.
The catheter according to any one of claims 8 to 11, wherein the tip member is configured separately from the catheter body and attached to the catheter body.
The catheter body has one or more through-holes penetrating the side wall of the catheter body near the tip opening,
at least part of the through-hole is positioned closer to the proximal side than the extension,
3. The catheter of claim 2, wherein at least a portion of said through-hole communicates with said channel.
The tip member includes a second body portion arranged to intersect the axial direction of the catheter body, and a second extension portion extending from the second body portion and at least partially inserted into the loading lumen. and a receptacle, which is configured separately from the catheter body and is detachable from the distal end of the catheter body,
The suppressing portion is formed in the second extending portion, and is configured such that the distal end side of the embolus loaded in the loading lumen is brought into contact by the water pressure generated during the priming operation,
The flow path is formed between one or more fourth internal spaces formed between the second extension portion and the catheter body, and between the second body portion and the catheter body, a fifth internal space communicating with each of the four internal spaces; and a fifth outlet communicating with the fifth internal space;
The catheter of claim 1, wherein the embolic material loaded into the loading lumen can be expelled through the tip opening when the tip member is removed from the catheter body.
The tip member includes a third body section arranged to intersect the axial direction of the catheter body, and a third extension section extending from the third body section and at least partially inserted into the loading lumen. and a receptacle, which is configured separately from the catheter body and is detachable from the distal end of the catheter body,
The suppressing portion is formed in the third extending portion, and is configured such that the distal end side of the embolus loaded in the loading lumen is brought into contact by the water pressure generated during the priming operation,
The catheter body has one or more through-holes near the tip opening that pass through the side wall of the catheter body and are located on the proximal side of the third extension,
at least part of the through-hole is positioned closer to the proximal side than the third extension,
at least part of the through-hole communicates with the flow path,
The catheter of claim 1, wherein the embolic material loaded into the loading lumen can be expelled through the tip opening when the tip member is removed from the catheter body.
a catheter according to any one of claims 1 to 15;
and the embolus loaded into the loading lumen.