WO2023048083A1 - Embolus-loaded catheter and medical device set - Google Patents

Abstract

[Problem] To prevent unintentional ejection of an embolus loaded in a catheter during a priming operation. [Solution] An embolus 10 loaded in an embolus-loaded catheter 20 has, on an outer peripheral surface of the embolus 10, a plurality of contact sections 11 that make contact with an inner peripheral surface 21a of a catheter body 21 defining a loading lumen 22 and that are subject to a movement-suppressing force suppressing movement of the embolus 10 in the axial direction of the catheter body 21. The catheter body 21 has an injection port for injecting fluid (priming fluid) into the loading lumen 22 via an injection hub, and a discharge port for discharging the fluid from the inside of the loading lumen 22. Further, in the loading lumen 22 in a state where the embolus 10 is loaded and the plurality of contact sections 11 are subject to the movement-suppressing force, a fluid flow path 28 is formed, extending from the distal end of the loading lumen 22 to the proximal end thereof and communicating with the injection port and the discharge port.

Description

Embolization pre-loaded catheter and medical device set

The present invention relates to embolus-loaded catheters and medical device sets.

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 the 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 (side branch vessels) branching from the aneurysm, etc. So-called "endoleak" 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. Since the sponge used in this device expands immediately when exposed to blood, it expands when it is pushed out into the aneurysm and absorbs the blood inside the aneurysm, and remains in that state in the aneurysm to increase blood flow. It cuts off and prevents 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. . Catheters for loading emboli have small diameters because they are used by inserting them into biological lumens such as blood vessels. Reloading is also unhygienic and there is room for improvement.

At least one embodiment of the present invention has been made in view of the circumstances described above. The purpose is to provide an instrument set.

In order to solve the above-mentioned problems, a catheter with an embolus loaded therein according to this embodiment communicates with an elongated catheter body and an embolus that swells upon contact with a liquid from the distal end to the proximal end of the catheter body. a loading lumen provided and loaded with the embolic material;
an injection hub having an insertion passage that communicates with the loading lumen and capable of injecting a fluid into the loading lumen; It has a plurality of contact portions that are in contact with the defining inner peripheral surface of the catheter body and receive a movement suppressing force that suppresses movement of the embolus in the axial direction of the catheter body, the catheter body comprising: an inlet for injecting the fluid into the loading lumen through the inlet hub and an outlet for discharging the fluid from the loading lumen; A fluid flow path extending from a distal end to a proximal end of the loading lumen and communicating with the inlet and the outlet is formed in the loading lumen in a state where the portion is subjected to the movement suppressing force. It is

Further, the medical instrument set according to the present embodiment includes the above-described embolus-loaded catheter and an elongated pusher that can be inserted into the loading lumen through the insertion passage of the proximal hub of the embolus-loaded catheter. a delivery pusher comprising a body.

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.

It is a figure which shows the structure of the medical instrument set and delivery system which concern on this embodiment. 1 is a diagram showing the configuration of an embolus delivery medical system according to this embodiment; FIG. 1 is a schematic partial cross-sectional view taken along an axial direction of an embolus-loaded catheter that constitutes a medical instrument set; FIG. FIG. 10 is a schematic cross-sectional view showing an example of the form of an embolus loaded in an embolus-loaded catheter. FIG. 10 is a schematic cross-sectional view showing an example of the form of an embolus loaded in an embolus-loaded catheter. FIG. 10 is a schematic cross-sectional view showing an example of the form of an embolus loaded in an embolus-loaded catheter. FIG. 10 is a schematic cross-sectional view showing an example of the form of an embolus loaded in an embolus-loaded catheter. FIG. 10 is a schematic cross-sectional view showing an example of the form of an embolus loaded in an embolus-loaded catheter. FIG. 10 is a schematic cross-sectional view showing an example of the form of an embolus loaded in an embolus-loaded catheter. 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 an operation example of the embolus delivery medical system according to the present embodiment, 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, showing a state in which the stent graft is deployed in the aneurysm. FIG. 10 is a diagram showing an operation example of the embolus delivery medical system, showing a state before the embolus-loaded catheter is attached to the delivery catheter. FIG. 10 is a diagram showing an operation example of the embolus delivery medical system, showing a state in which an embolus-loaded catheter is attached to the delivery catheter. FIG. 10 is an operation example of the embolus delivery medical system, showing a state during insertion of the delivery pusher into the embolus-loaded catheter. FIG. 10 is an operation example of the embolus delivery medical system, 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 embolus delivery medical system, showing a state in which an embolus-loaded catheter is detached from the delivery catheter. FIG. 11 is a schematic perspective view of an embolus-loaded catheter loaded with an embolus (circular spiral shape) according to Modification 1; FIG. 11 is a schematic perspective view of an embolus-loaded catheter loaded with an embolus (triangular spiral shape) according to modification 1; FIG. 10 is a schematic perspective view of an embolus-loaded catheter loaded with an embolus (square spiral shape) according to modification 1; FIG. 8B is a schematic cross-sectional view of the embolus-loaded catheter shown in FIG. 8A. FIG. 8B is a schematic cross-sectional view of the embolus-loaded catheter shown in FIG. 8B. FIG. 8D is a schematic cross-sectional view of the embolus-loaded catheter shown in FIG. 8C. FIG. 10 is a schematic perspective view of an embolus-loaded catheter loaded with an embolus (zigzag shape) according to Modification 1; FIG. 10 is a schematic perspective view of an embolus-loaded catheter loaded with an embolus (wavy shape) according to Modification 1; 10B is a schematic cross-sectional view of the embolus-loaded catheter shown in FIGS. 10A and 10B. 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.

Furthermore, 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.

In the medical instrument set 100, the delivery system 200, and the embolus delivery medical system 300 according to the present embodiment, the side to be inserted into a biological lumen (such as a blood vessel) is defined as the "tip", and the side opposite to the tip (grasped by the operator). side) is referred to as the “proximal end”. Also, the term "distal end" means a certain range in the axial direction (longitudinal direction) from the distal end, and the term "base end" means a certain range in the axial direction from the most proximal end.

It should be noted that, in the following description, when describing with ordinal numbers such as "first" and "second", unless otherwise specified, it is used for convenience and does 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, the medical device set 100, the delivery system 200, and the embolus delivery medical system 300 according to the present embodiment can be applied not only to the above-described endoleak embolization, but also to blood vessels and other biological lumens. It can also be applied to other interventional treatments to prevent rupture of aneurysms in

FIG. 1 shows the devices constituting the medical instrument set 100 and the delivery system 200 according to this embodiment, and FIG. 2 shows the devices constituting the embolism delivery medical system 300 according to this embodiment. It is shown.

<Medical instrument set>
The medical instrument set 100 includes an embolus-loaded catheter 20 loaded with an 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 embolus 10 is loaded into the catheter 20 loaded with the embolus, and the catheter 20 loaded with the embolus is pushed out by the pusher 30 for delivery while being attached to the catheter 40 for delivery 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.

Here, "physiological condition" means a condition that has 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 20 and the delivery catheter 40, and can be, for example, approximately 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.

The embolus 10 is in contact with the inner peripheral surface 21a of the catheter body 21 defining the loading lumen 22 of the catheter 20 loaded with the embolus, thereby suppressing movement of the embolus 10 in the axial direction of the catheter body 21. A plurality of contact portions 11 that receive force are provided on the outer peripheral surface.

Here, the “movement suppression force” is a force that acts along the radial direction of the catheter body 21 and suppresses the axial movement of the embolus 10 against the axial pressing force applied to the embolus 10. is. Specifically, the movement suppressing force is defined as "the pressure resulting from the compressive force that compresses the embolus 10 from the inner peripheral surface 21a of the catheter body 21 toward the axial center of the catheter body 21" pressure due to a restoring force (pulling force) directed from the axial center of the embolization object 10 toward the inner peripheral surface 21a of the catheter body 21 due to the resilience of the embolism object 10 when it is applied.

The movement-suppressing force has a force that prevents the embolus 10 from unintentionally popping out of the catheter body 21 at least during the priming operation, and that allows the embolus 10 to be ejected during an intentional ejection operation using the delivery pusher 30 or the like. Therefore, the embolus 10 does not jump out of the catheter main body 21 against the pressing force (water pressure) received from the priming liquid during the priming operation, and is smoothly expelled without interfering with the ejection operation. As described above, the movement-suppressing force is a force resulting from a compressive force or a restoring force. Appropriate force can be adjusted by appropriately setting the adjustment element. Further, the movement suppressing force can be made more appropriate by adjusting the frictional force caused by the materials of the embolization object 10 and the catheter main body 21 in addition to these adjusting elements.

As shown in FIG. 3, the plurality of contact portions 11 of the embolus 10 receive a movement-suppressing force, so that the apparent normal force N increases, and the relation of "stationary friction force F>pressing force P by the priming liquid" is satisfied. Easier to maintain relationships. Therefore, during the priming operation, the embolus 10 stays in the loading lumen 22 against the pressing force P of the priming solution and does not jump out of the catheter main body 21 .

In addition, in the loading lumen 22 loaded with the embolus 10, there is a liquid (priming liquid) that extends from the distal end to the proximal end of the loading lumen 22 and that the catheter main body 21 of the catheter 20 with the embolus loaded has. ) are formed in fluid flow passages 28 communicating with inlets and outlets of .

A fluid flow path 28 is formed within the loading lumen 22 with the embolus 10 loaded. The fluid flow path 28 communicates with a liquid injection part having an injection port into the loading lumen 22 through which liquid can be injected, and communicates with a liquid injection part having an outlet through which the liquid can be discharged from the loading lumen 22, A liquid such as a priming liquid is configured to flow. In this embodiment, the injection port is an opening on the distal end side of the insertion passage 23a of the proximal hub 23 that functions as a liquid injection part, and communicates with the opening on the liquid injection side of the fluid channel 28 . In this embodiment, the outlet is an opening on the distal end side of the loading lumen 22 that functions as a liquid outlet, and communicates with an opening on the liquid outlet side of the fluid channel 28 .

The injection port communicating with the fluid flow path 28 is not limited to the opening on the distal side of the insertion passage 23a of the proximal hub 23. Any opening may be used. Further, the discharge port communicating with the fluid flow path 28 is not limited to the opening on the distal end side of the loading lumen 22, and may be any liquid discharge opening provided in the catheter body 21 and communicating with the loading lumen 22. Just do it.

In this embodiment, the embolus 10 is shorter than the total length of the loading lumen 22 of the embolus-loaded catheter 20 as shown in FIG. Therefore, the fluid flow path 28 includes at least a portion of the loading lumen 22 (the space extending in the axial direction of the embolus 10), the inner peripheral surface 21a of the catheter body 21 defining the loading lumen 22, and the embolus. 10 and the first fluid flow path 28a formed of a gap formed between the outer peripheral surface of the first fluid flow path 28a. In addition, the fluid flow path 28 includes at least a portion of the loading lumen 22 and a second fluid flow path 28 b formed from a gap formed inside the embolus 10 from the proximal end to the distal end of the embolus 10 . good too. Further, fluid flow path 28 may include at least a portion of loading lumen 22, first fluid flow path 28a and second fluid flow path 28b.

In addition, when the total length of the embolus 10 and the total length of the loading lumen 22 are substantially the same, the fluid flow path 28 is formed by at least one of the first fluid flow path 28a and the second fluid flow path 28b. . One of the openings of the fluid flow path 28, which is composed only of the first fluid flow path 28a and the second fluid flow path 28b, communicates with the injection port (the opening on the distal end side of the proximal hub 23 in this embodiment). , the other opening communicates with the discharge port (the opening on the distal end side of the loading lumen 22).

Thus, the embolus-loaded catheter 20 has a fluid flow path 28 formed in the loading lumen 22 with the embolus 10 loaded therein. Therefore, when the embolus-loaded catheter 20 is primed, the priming solution is injected into the loading lumen 22 of the embolus-loaded catheter 20 and then flows smoothly from the loading lumen 22 through the fluid flow path 28 . Ejected. Therefore, the embolus 10 is less likely to protrude from the catheter main body 21 because the pressing force received from the priming solution is reduced, coupled with the movement restraining effect of the movement restraining force.

4A to 4C and FIGS. 5A to 5C show schematic cross-sectional views of various forms of the embolus 10 according to the present embodiment, which are loaded into the loading lumen 22 of the catheter 20 loaded with the embolus. ing. The embolus-loaded catheter 20 shown in FIGS. 4A to 4C and FIGS. 5A to 5C is loaded into the loading lumen 22 in a state where the contact portion 11 receives a movement restraining force in any of the configurations. , a fluid flow path 28 is formed.

As shown in FIGS. 4A to 4C, the embolus 10 (emboli 10A to 10C) has an outer peripheral surface 21a of the catheter body 21 defining the loading lumen 22 of the catheter 20 loaded with the embolus. , a plurality of locations on the outer peripheral surface function as contact portions 11 (contact portions 11A to 11C). The contact portions 11A to 11C come into contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. In a state in which the embolus 10A to 10C are loaded in the loading lumen 22, a first fluid flow path 28a is formed in the loading lumen 22 by the gap between the embolus 10 and the inner peripheral surface 21a. be. The contact form of the contact portions 11A to 11C with the inner peripheral surface 21a may be either point contact or surface contact, and is particularly limited as long as they are in contact with the inner peripheral surface 21a while receiving a movement suppressing force. no.

As shown in FIG. 4A, the embolus 10A has an elliptical cross-sectional shape. The embolus 10A functions as a contact portion 11A at its ends (two points in the drawing) in the longitudinal direction, and is in contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. Further, as shown in FIG. 4A, two gaps formed between the plug 10A and the inner peripheral surface 21a function as first fluid flow paths 28a.

As shown in FIG. 4B, the embolus 10B has a star-shaped polygon (star-shaped regular heptagon) in cross section. The embolus 10B functions as a contact portion 11B at each vertex (seven points in the figure) facing the inner peripheral surface 21a, and is in contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. Further, as shown in FIG. 4B, seven gaps formed between the plug 10B and the inner peripheral surface 21a function as first fluid flow paths 28a.

As shown in FIG. 4C, the embolus 10C has a cross-sectional shape. The embolus 10C functions as a contact portion 11C at the corners (eight locations in the drawing) of the apex facing the inner peripheral surface 21a, and contacts the inner peripheral surface 21a of the catheter main body 21 while receiving a movement suppressing force. ing. Further, as shown in FIG. 4C, eight gaps formed between the plug 10C and the inner peripheral surface 21a function as first fluid flow paths 28a.

As shown in FIGS. 5A to 5C, the embolus 10 (embolus 10D to 10F) has an external shape that is substantially the same as the shape of the inner peripheral surface 21a of the catheter body 21 defining the loading lumen 22. , substantially the entire outer peripheral surface functions as the contact portion 11 (contact portions 11D to 11F). The contact portions 11D to 11F come into contact with the inner peripheral surface 21a of the catheter body 21 while receiving movement suppressing force. In the state where the embolus 10D to 10F are loaded in the loading lumen 22, a second fluid flow path is provided in the loading lumen 22 by a gap formed inwardly from the distal side to the proximal side of the embolus 10. 28b is formed.

As shown in FIG. 5A, the embolus 10D has a substantially cylindrical cross-sectional shape. Approximately the entire outer peripheral surface of the embolus 10D functions as a contact portion 11D, and is in contact with the inner peripheral surface 21a of the catheter main body 21 while being subjected to a movement suppressing force at a plurality of locations on the outer peripheral surface. In addition, as shown in FIG. 5A, a lumen (gap) formed in the embolus 10D in communication from the distal end to the proximal end functions as a second fluid channel 28b.

As shown in FIG. 5B, the embolus 10E has a substantially circular cross-sectional shape, and a plurality of micropores (regardless of whether the hole shape is circular or polygonal) are formed inside. Approximately the entire outer peripheral surface of the embolus 10E functions as a contact portion 11E, and is in contact with the inner peripheral surface 21a of the catheter main body 21 while being subjected to a movement suppressing force at a plurality of locations on the outer peripheral surface. Further, as shown in FIG. 5B, a plurality of holes (gaps) formed in communication from the distal end side to the proximal end side of the embolization object 10E function as second fluid flow paths 28b. The embolization object 10E is not particularly limited in terms of the opening size and the number of micropores formed, and may have any configuration that allows liquid to flow while ensuring the function of the embolization object 10. FIG.

As shown in FIG. 5C, the embolus 10F has a helical cross-sectional shape. The embolus 10F is formed, for example, in a rectangular plate shape in a plan view, and then rolled in a lateral direction perpendicular to the axial direction so as to be accommodated in the loading lumen 22 . Approximately the entire outermost peripheral surface of the embolus 10F functions as a contact portion 11F, and is in contact with the inner peripheral surface 21a of the catheter main body 21 while being subjected to a movement suppressing force at multiple locations on the outermost peripheral surface. Further, as shown in FIG. 5C, a space having a spiral cross-section formed in communication from the distal end side to the proximal end side of the embolus 10F functions as a second fluid flow path 28b.

As described above, the embolus 10A to 10F are loaded into the loading lumen 22 in a state in which the contact portions 11A to 11F are in contact with the inner peripheral surface 21a of the catheter body 21 while receiving the movement suppressing force. be. In the loading lumen 22 loaded with the embolus 10A to 10F, there is a fluid flow path 28 including at least one of a first fluid flow path 28a and a second fluid flow path 28b through which the priming liquid can flow. is formed. Since the priming fluid flows through the fluid flow path 28 and into the loading lumen 22, the pressure force applied to the occlusive object 10 during the priming operation is significantly greater than that of a device having a conventional configuration that does not have the fluid flow path 28. reduced. In addition, since the embolus 10 is loaded into the loading lumen 22 while the contact portion 11 receives the movement suppressing force, it can stay in the loading lumen 22 against the pressing force of the priming solution. Therefore, the embolus-loaded catheter 20 is prevented from unintentionally ejecting the embolus 10 during the priming operation.

The embolus 10 is not limited to the shapes shown in FIGS. 4A to 4C and FIGS. 5A to 5C. The embolus 10 has a plurality of contact portions 11 which receive a movement suppressing force while being in contact with the inner peripheral surface 21a of the catheter body 21 at least when loaded into the loading lumen 22, and is loaded into the loading lumen 22. The priming liquid injected into the charging lumen 22 from the injection port (for example, the opening on the distal end side of the proximal hub 23) is discharged from the discharge port (for example, the opening on the distal side of the loading lumen 22). It is sufficient that the fluid flow path 28 including the first fluid flow path 28a and the second fluid flow path 28b can be formed so as to be discharged from the fluid flow path 28a. Further, the plug 10 may have a shape having the contact portion 11 only partially in the axial direction.

As another example of the configuration of the embolization object 10, in the configuration in which the first fluid flow path 28a can be formed as shown in FIGS. At least one helically wavy groove (thread groove-shaped spiral groove) is provided along the groove, the groove functions as the first fluid flow path 28a, and the outer peripheral surface other than the groove functions as the contact portion 11. .

Also, the plug 10 can be configured to include both the first fluid channel 28a and the second fluid channel 28b. For example, an obturator 10A having an elliptical cross section shown in FIG. 4A may be provided with a lumen extending axially from the distal end to the proximal end as shown in FIG. 5A.

<Cather with embolus loaded>
The embolus-loaded catheter 20 includes an elongated catheter body 21 having a loading lumen 22 provided therein, a proximal hub 23 provided on the proximal side of the catheter body 21, and a proximal hub 23 at one end. It has a flexible tube 24 which is connected to the proximal side and whose other end is connected to a port 26 of a stopcock 25 .

The catheter main body 21 is a tubular member in which a hole (loading lumen 22) communicating from an opening on the distal end side to an opening on the proximal end side along the axial direction is formed. 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 20 and the delivery catheter 40 .

The embolus-loaded catheter 20 is mainly supplied with the embolus 10 pre-loaded. You can load it inside. As a method of loading the embolus 10, the operator can grasp the embolus 10 and insert it into the catheter 20 loaded with the embolus from the distal connecting portion 27 side or the proximal hub 23 side.

The catheter body 21 with the embolus 10 housed therein is attached by engaging with the sheath hub 43 of the delivery catheter 40 via the distal connection portion 27 . 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 embolus-loaded catheter 20 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 embolus 10 loaded 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 configuration in which the wall thickness is variable, the outer diameter of the catheter main body 21 is larger than the outer diameter of the sheath 41, but the catheter 20 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 embolization-loaded catheter 20 . 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 adopted.

The distal end connection part 27 is provided on the distal end side of the catheter 20 loaded with the embolus, and is detachably connected to the proximal end side of the sheath hub 43 of the delivery catheter 40 . The distal connection portion 27 includes an engaging concave portion formed on the inner peripheral surface of the communicating passage 43a of the sheath hub 43 on the proximal end side, an elastically deformable engaging convex portion projecting radially outward from the distal connecting portion 27, It is possible to adopt a so-called snap-fit configuration. The form of connection of the distal end connecting part 27 to the sheath hub 43 is not particularly limited, and other forms of connection such as a threaded type, for example, that maintain the connected state between the catheter 20 loaded with the embolus and the delivery catheter 40 are adopted. You can also In addition, the catheter 20 loaded with the embolus and the delivery catheter 40 should be connected at least in the connected state so that the embolus 10 can move.

<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 by the operator while the handle portion 32 is gripped in a state where the catheter 20 loaded with the embolus is attached to the delivery catheter 40, the embolus 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 pushes out the embolic material 10 loaded in the embolus-loaded catheter 20 to the outside ( into the aneurysm).

The body length of the pusher main 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 20 loaded with the embolic material 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 in which the catheter 20 loaded with the embolus and the delivery catheter 40 are attached, the embolus loaded in the loading lumen 22 can be pushed out by a single pushing operation. The object 10 can be passed through the insertion path 23a→sheath hub 43→sheath lumen 42 in this order and pushed out into the aneurysm.

As shown in FIG. 6A, the handle portion 32 has a substantially mushroom-shaped 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. 6B, when the delivery pusher 30 is inserted into the embolus-loaded catheter 20, the large-diameter head 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, the withdrawal operation of the catheter 20 loaded with the embolus is performed when the operation of pushing out the embolus 10 by the delivery pusher 30 is completed. 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 20 prior to the withdrawal operation of the embolus-loaded catheter 20 .

The handle portion 32 may be configured such that the large diameter head portion 32a can be fitted to the proximal side of the proximal hub 23 when the catheter 20 is inserted into the catheter 20 loaded with the embolization material. With such a configuration, when the catheter 20 loaded with the embolus is removed, the delivery pusher 30 can be reliably pulled out from the catheter 20 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 instrument set 100, a delivery catheter 40 to which the embolized material-loaded catheter 20 is 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 loaded with the embolus and the delivery catheter 40 are connected by the engaging portion 60 .

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 the sheath 41 through the embolus-loaded catheter 20 and guiding the embolus 10 pushed out from the embolus-loaded catheter 20 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 20 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 hemostasis valve is attached to the inner side of the proximal end of the sheath hub 43 . 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 the present embodiment, the delivery catheter 40 is a catheter having an outer diameter of 6 Fr (inner diameter of 1.8 mm), and the applied technique is endoleak embolization for stent graft insertion of an abdominal aortic aneurysm (AAA). In the case of surgery, the outer diameter of the embolus 10 is 0.4 to 1.9 mm (preferably about 1.6 mm), and the inner diameter of the catheter 20 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 1.8 mm). The length of the catheter body 21 of the catheter 20 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 47 cm), and the delivery pusher The body length of the pusher body 31 of 30 can be 79 to 205 cm (preferably about 96 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 30 to 100 cm (preferably about 40 cm) from the viewpoints of ease of loading into the catheter 20 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 reference to FIGS. 7A to 7G as appropriate.

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 an elliptical shape. 7C to 7G, "A" indicates inside an aneurysm, "V" indicates inside a blood vessel, and "O" indicates outside the body. expressed in

First, as a preoperative preparation step, as shown in FIG. 7A, 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. 7A). ) is percutaneously inserted into the biological lumen, and the tip opening 41a of the delivery catheter 40 is delivered to the abdominal aortic aneurysm. When the tip opening 41a is delivered into the aneurysm, the insertion assisting member 50 is removed. The delivery catheter 40 may be delivered to the affected area of the aneurysm using a guide wire previously inserted into the aneurysm without using the insertion assisting member 50 . Also, the delivery catheter 40 is primed before it is introduced into the body lumen.

Next, as shown in FIG. 7B, 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 a guide wire that has been inserted into the aneurysm in advance. 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. 7B, the delivery catheter 40 is placed between the leg of the stent graft SG and the vessel wall, and the tip 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. 7C, an embolus-loaded catheter 20 loaded with the embolus 10 is prepared. FIG. 7C shows the embolus-loaded catheter 20 before it is attached to the delivery catheter 40 .

The operator performs a priming operation before attaching the catheter 20 loaded with the embolus to the delivery catheter 40 . The embolization object 10 is loaded with the contact portion 11 in contact with the inner peripheral surface 21 a of the catheter body 21 . The contact portion 11 of the embolus 10 receives a movement suppressing force, which is a force along the radial direction of the catheter body 21 . In the loading lumen 22 loaded with the embolus 10, the priming solution that extends from the distal end to the proximal end of the loading lumen 22 and that the catheter body 21 of the catheter 20 with the embolus loaded has is injected. A fluid flow path 28 is formed that communicates with an inlet (distal opening of proximal hub 23) and an outlet (distal opening of loading lumen 22).

In the priming operation, when the priming liquid is injected from the inlet, it passes through the fluid channel 28 and flows through the loading lumen 22, and then is discharged from the outlet. Therefore, the embolus 10 receives less pressing force from the priming solution. In addition, since the embolus 10 is loaded in contact with the inner peripheral surface 21a of the catheter main body 21 in a state in which a movement suppressing force acts on the contact portion 11, it stays on the catheter main body 21 against the pressing force of the priming solution. maintained. Therefore, in the embolus-loaded catheter 20, the embolus 10 does not protrude from the catheter main body 21 during the priming operation. That is, the embolus-loaded catheter 20 is prevented from unintentionally popping out during the priming operation.

After completing the priming operation of the embolus-loaded catheter 20, the operator attaches the distal end connecting portion 27 of the embolus-loaded catheter 20 to the proximal end of the sheath hub 43 of the delivery catheter 40, as shown in FIG. 7D. . At this time, the axial center of the loading lumen 22 is aligned with the axial center of the see lumen 42 .

Next, 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, as shown in FIG. 7E. 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 20, 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. 7F, the operator pushes out the delivery pusher 30 inserted from the proximal hub 23 to push out the embolus 10 from the sheath lumen 42 into the aneurysm. Thereafter, the operator withdraws the emptied embolus-loaded catheter 20 together with the delivery pusher 30 from the delivery catheter 40, as shown in FIG. 7G. The delivery pusher 30 can be removed from the delivery catheter 40 while inserted into the embolus-loaded catheter 20 . This completes the first insertion operation of the embolization object 10 into the aneurysm. During the insertion operation, the delivery pusher 30 may be withdrawn from the embolus-loaded catheter 20 prior to the withdrawal operation of the embolus-loaded catheter 20 .

In endoleak embolization, a series of embolus placement operations shown in FIGS. 7C to 7G 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 20 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 may be pulled out from the aneurysm and the biological lumen. good. Alternatively, the delivery pusher 30 may be withdrawn from the delivery catheter 40 while the embolus-loaded catheter 20 is withdrawn from the delivery catheter 40 before the delivery catheter 40 is withdrawn from the aneurysm and biological 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 20, and then the embolus-loaded catheter 20 is pulled out of 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.

[Modification]
The embodiment described above can be modified as follows. Also, the following modifications can be arbitrarily combined within the scope of the present invention. In the modified examples described below, constituent elements having the same functions as those of the embodiment described above are denoted by the same reference numerals, and detailed description thereof is omitted. It may be similar to the form.

<Modification 1>
The embolus 10 (embolus 10G to 10M) according to Modification 1 extends along the axial direction of the loading lumen 22, and the embolus 10 extends along the axial direction of the loading lumen 22, as shown in any of FIGS. A portion of the outer peripheral surface of the catheter functions as a contact portion 11 (contact portions 11G to 11M) to form a linear structure that contacts the inner peripheral surface 21a of the catheter body 21 defining the loading lumen 22. Here, the “linear structure” refers to a non-linear three-dimensional structure including a secondary structure such as a helical shape, a zigzag shape, a wave shape, etc., and is in contact with the inner peripheral surface 21a of the catheter body 21 at multiple points. do.

The embolus 10D to 10F according to the modified example 1 have the above-described linear structure, and the contact portions 11G to 11M receive the movement suppressing force, and the inner peripheral surface 21a of the catheter body 21 and a plurality of locations. It is loaded into the loading lumen 22 in contact. In the state in which the embolus 10D to 10F are loaded in the loading lumen 22, the embolus facing between the embolus 10 and the inner peripheral surface 21a and in the radial direction of the catheter main body 21 are present in the loading lumen 22. A third fluid flow path 28c is formed which is formed by the air gap between the articles 10 . The form of contact between the contact portion 11 and the inner peripheral surface 21a is not particularly limited, and may be point contact or surface contact.

FIGS. 8A to 8C show schematic perspective views of an embolus-loaded catheter 20 loaded with helical forms (emboli 10G to embolus 10K) of the embolus 10 according to Modification 1. FIG. . 9A-9C show schematic cross-sectional views of embolus-loaded catheter 20 loaded with emboli 10G-10K.

As shown in FIG. 8A, the plug 10G extends along the axial direction of the loading lumen 22 and has an elliptical spiral shape when viewed from the axial direction. The end of the embolism 10G functions as a contact portion 11G, and is in contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. Further, as shown in FIG. 9A, the gaps formed between the embolus 10G and the inner peripheral surface 21a and between the embolus 10G facing each other in the radial and axial directions of the catheter body 21 are the third fluid flow paths 28c. function as

As shown in FIG. 8B, the plug 10H extends along the axial direction of the loading lumen 22 and has a triangular spiral shape (triangular spiral shape) when viewed from the axial direction. The embolus 10H has a triangular apex functioning as a contact portion 11H, and is in contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. Further, as shown in FIG. 9B, the gaps formed between the embolus 10H and the inner peripheral surface 21a and between the embolus 10H facing each other in the radial and axial directions of the catheter body 21 are the third fluid flow paths 28c. function as

As shown in FIG. 8C, the embolus 10K extends along the axial direction of the loading lumen 22 and has a quadrangular helical shape (square helical shape) when viewed from the axial direction. The embolus 10K has a quadrangular apex functioning as a contact portion 11K, and is in contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. Further, as shown in FIG. 9C, the gaps formed between the embolus 10K and the inner peripheral surface 21a and between the embolus 10K facing each other in the radial direction and the axial direction of the catheter body 21 are the third fluid flow paths 28c. function as

In FIGS. 10A and 10B, of the embolus 10 according to Modification 1, examples of forms (emboli 10L, embolus 10M) having a linear structure (zigzag shape, wave shape) other than a spiral shape are loaded. A schematic perspective view of an embolus-loaded catheter 20 is shown. FIG. 11 shows a schematic cross-sectional view of embolus-loaded catheter 20 loaded with embolus 10L or embolus 10M.

As shown in FIG. 10A , the embolus 10L has a zigzag shape (triangular wave shape) extending along the axial direction of the loading lumen 22 . The embolus 10L has a zigzag vertex functioning as a contact portion 11L, and is in contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. In addition, as shown in FIG. 11, the gap formed between the plugging object 10L and the inner peripheral surface 21a or between the plugging objects 10L facing each other in the axial direction functions as the third fluid flow path 28c.

As shown in FIG. 10B, the plug 10M has a wave shape (sine wave shape) extending along the axial direction of the loading lumen 22. As shown in FIG. The crest of the embolus 10M functions as a contact portion 11M, and is in contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. Further, as shown in FIG. 11, the gaps formed between the plugging object 10M and the inner peripheral surface 21a or between the plugging objects 10M facing each other in the axial direction function as the third fluid flow path 28c.

As described above, in the embolus-loaded catheter 20 according to Modification 1, each of the emboli 10G to 10M having a nonlinear linear structure extending in the axial direction of the loading lumen 22 is a contact portion. The catheter body 21 is loaded into the loading lumen 22 by contacting the inner peripheral surface 21a of the catheter main body 21 at a plurality of points in a state where the contact portions 11G to 11M receive movement suppressing force. Further, in the catheter main body 21 loaded with the embolus 10G to 10M, a fluid channel 28 including a third fluid channel 28c through which the priming liquid can flow is formed. Therefore, the embolization material-loaded catheter 20 according to Modification 1 prevents the embolization material 10 from unintentionally popping out during the priming operation, similar to the embodiments shown in FIGS. 4A to 4C and FIGS. 5A to 5C. be.

It should be noted that the embolization material-loaded catheter 20 according to Modification 1 can also arbitrarily combine the forms shown in FIGS. 8A to 8C, 10A, and 10B described above. For example, the obturator 10 may have a helical shape as shown in FIG. 8A from the distal end to the intermediate portion, and a zigzag shape as shown in FIG. 10A from the intermediate portion to the proximal end.

Further, the embolus-loaded catheter 20 according to Modification 1 is not limited to the forms shown in FIGS. It is sufficient that the embolus 10 having a linear structure that functions as the contact portion 11 and contacts the inner peripheral surface 21 a of the catheter body 21 defining the loading lumen 22 is loaded. Alternatively, the embolus 10 may have a linear structure in which only a portion thereof is in contact with the inner peripheral surface 21 a of the catheter body 21 defining the loading lumen 22 .

<Other Modifications>
In the above-described embodiment, the configuration shown in FIGS. 4A to 4C has a circular shape of the inner peripheral surface 21a of the catheter body 21 defining the loading lumen 22, and a cross section in a direction perpendicular to the axial direction of the embolus 10. The shape or the shape viewed from the axial direction is different from the inner peripheral surface 21a of the catheter main body 21 (that is, non-circular). However, the shape of the embolus 10 should be at least different from the shape of the inner peripheral surface 21 a of the catheter body 21 . Therefore, the shape of the inner peripheral surface 21a of the catheter body 21 may be non-circular, and the embolus 10 may be configured to be circular inscribed in the inner peripheral surface 21a. Thus, even if the shape of the inner peripheral surface 21a of the catheter body 21 is non-circular and the cross-sectional shape of the embolus 10 is circular different from the inner peripheral surface 21a, the contact portion 11 that contacts the inner peripheral surface 21a of the catheter body 21 is A fluid flow path 28 is formed in the loading lumen 22 to be loaded into the loading lumen 22 while receiving a movement restraining force, and includes a first fluid flow path 28a and a second fluid flow path 28b. Therefore, the embolus-loaded catheter 20 prevents the embolus 10 from unintentionally popping out during the priming operation.

In addition, the embolus 10 can be appropriately combined with each of the above-described forms (the embolus 10A to the embolus 10M). Therefore, the embolus 10 has a form in which arbitrarily selected embolus 10A to 10F are combined, and a form in which arbitrarily selected embolus 10G to 10M are combined. A form in which an embolus arbitrarily selected from the embolus 10A to 10F and an embolus 10G to 10M arbitrarily selected can be combined.

In addition, as shown in FIGS. 7A to 7G, the embolus delivery medical system 300 according to the above-described embodiment, as a delivery method for the embolus 10, is placed on the proximal end side of the delivery catheter 40 indwelled in the biological lumen. A method was employed in which the tip side of the catheter 20 loaded with the embolus was attached, the delivery pusher 30 was inserted into the catheter 20 loaded with the embolus, and the embolus 10 was ejected into the aneurysm. However, the embolus delivery medical system 300 is not limited to the above-described delivery methods, and may have a device configuration compatible with other delivery methods (for example, "direct insertion method" or "indirect insertion method"). can also produce the same effect. Here, the “indirect insertion method” refers to inserting a second catheter (corresponding to the embolus-loaded catheter 20) loaded with the embolus 10 into the first catheter (corresponding to the delivery catheter 40). Then, with the tip of the second catheter reaching the aneurysm, a delivery pusher (corresponding to the delivery pusher 30) is inserted into the second catheter to deliver the embolus 10 into the aneurysm. . In addition, the "indirect insertion method" refers to a first catheter in which part of the tip of a second catheter (corresponding to the catheter 20 loaded with the embolus) loaded with the embolus 10 is left in the body lumen. catheter (corresponding to the delivery catheter 40), insert the loading pusher into the second catheter to transfer the embolus 10 to the first catheter, and move the second catheter to the first catheter. After removing it from the catheter, a pusher for delivery (corresponding to the pusher for delivery 30) is inserted into the first catheter to deliver the embolus 10 into the aneurysm. The medical instrument set 100, the delivery system 200, and the embolus delivery medical system 300 according to the present embodiment can be used in any of the embolus delivery methods described above when the embolus-loaded catheter 20 is primed. can be prevented from unintentionally popping out.

[Effect]
As described above, the catheter 20 loaded with the embolus according to the present embodiment communicates with the elongated catheter body 21 and the embolus 10 that swells when it comes into contact with liquid, from the distal end to the proximal end of the catheter body 21 . and has a loading lumen 22 loaded with the embolus 10 and an insertion path (insertion path 23a) communicating with the loading lumen 22 so that a fluid (priming solution) can be injected into the loading lumen 22. It has an injection hub (proximal hub 23). On the outer peripheral surface of the embolus 10, the embolus 10 contacts the inner peripheral surface 21a of the catheter body 21 defining the loading lumen 22 to suppress the movement of the embolus 10 in the axial direction of the catheter body 21. It has a plurality of contact portions 11 receiving a movement restraining force. Catheter body 21 has an inlet for injecting fluid into loading lumen 22 via an injection hub and an outlet for discharging fluid from within loading lumen 22 . In the loading lumen 22 loaded with the embolus 10 and in a state where the plurality of contact portions are subjected to the movement suppressing force, the loading lumen 22 extends from the distal end to the proximal end, and the injection A fluid flow path 28 is formed in communication with the inlet and outlet.

With such a configuration, the embolus 10 is loaded into the loading lumen 22 in a state where the plurality of contact portions 11 are subjected to movement suppressing force. can stay. In addition, since the fluid channel 28 communicating with the inlet and the outlet is formed in the loading lumen 22 loaded with the embolus 10 , the priming solution flows through the fluid channel 28 into the loading lumen 22 . can be distributed. Therefore, even if the embolus-loaded catheter 20 is primed with the embolus 10 loaded in the catheter body 21, the embolus 10 can be prevented from unintentionally popping out.

In addition, in the embolus-loaded catheter 20 according to the present embodiment, the embolus 10 has a different shape from the inner peripheral surface 21a of the catheter body 21 defining the loading lumen 22 in the cross section in the direction perpendicular to the axial direction. has a plurality of contact portions 11 that come into contact with the inner peripheral surface 21a of the catheter body 21, and the fluid flow path 28 is formed at least between the inner peripheral surface 21a of the catheter body 21 and the outer peripheral surface of the embolus 10. It may be configured to include the first fluid flow path 28a composed of a gap formed between.

With such a configuration, the embolus 10 is loaded into the loading lumen 22 in contact with the inner peripheral surface 21a of the catheter main body 21 while the plurality of contact portions 11 on the outer peripheral surface receive a movement suppressing force. The loading lumen 22 loaded with the embolus 10 also includes a first fluid channel 28a which is a gap formed between the inner peripheral surface 21a of the catheter body 21 and the outer peripheral surface of the embolus 10. A fluid flow path 28 is formed. Therefore, the priming liquid is injected through the inlet and discharged through the outlet through the fluid flow path 28 . Since the embolus 10 is loaded into the loading lumen 22 while the contact portion 11 receives a movement suppressing force, it stays in the loading lumen 22 against the pressing force of the priming solution. Therefore, even if the embolus-loaded catheter 20 is primed with the embolus 10 loaded in the catheter main body 21, the embolus 10 can be prevented from unintentionally popping out.

In addition, in the embolization-loaded catheter 20 according to the present embodiment, the fluid flow path 28 is a second fluid flow path 28 b that is formed at least from the proximal end to the distal end of the embolization material 10 and formed inside the embolization material 10 . may be configured to include

With such a configuration, substantially the entire outer peripheral surface of the embolus 10 functions as the contact portion 11, and the contact portion 11 is loaded while being in contact with the inner peripheral surface 21a of the catheter body 21 while receiving a movement suppressing force. It is loaded into the lumen 22 for use. In addition, in the loading lumen 22 loaded with the embolus 10, a fluid flow path 28 including a second fluid flow path 28b is formed by the embolus 10 and a gap formed inside the embolus 10 from the proximal end to the distal end. is formed. Therefore, the priming liquid is injected through the inlet and discharged through the outlet through the fluid flow path 28 . Since the embolus 10 is loaded into the loading lumen 22 while the contact portion 11 receives a movement suppressing force, it stays in the loading lumen 22 against the pressing force of the priming solution. Therefore, even if the embolus-loaded catheter 20 is primed with the embolus 10 loaded in the catheter main body 21, the embolus 10 can be prevented from unintentionally popping out.

In the embolus-loaded catheter 20 according to the present embodiment, the embolus 10 extends along the axial direction of the loading lumen 22 and has a plurality of contact portions that contact the inner peripheral surface 21 a of the catheter body 21 . 11, and the fluid channel 28 may include at least a third fluid channel 28c consisting of a gap formed between the inner peripheral surface 21a of the catheter body 21 and the embolus 10. good.

With such a configuration, a portion of the outer peripheral surface of the embolus 10 functions as the contact portion 11, and the contact portion 11 is loaded while being in contact with the inner peripheral surface 21a of the catheter main body 21 while receiving a movement suppressing force. It is loaded into the lumen 22 for use. Further, in the loading lumen 22 loaded with the embolization material 10, there is at least a third fluid flow path 28c consisting of a gap formed between the inner peripheral surface 21a of the catheter body 21 and the embolization material 10. A path 28 is formed. Thus, the priming liquid is injected through the inlet and discharged through the outlet through the fluid flow path 28 . Since the embolus 10 is loaded into the loading lumen 22 while the contact portion 11 receives a movement-suppressing force, it stays in the loading lumen 22 against the pressing force of the priming solution. Therefore, even if the embolus-loaded catheter 20 is primed with the embolus 10 loaded in the catheter main body 21, the embolus 10 can be prevented from unintentionally popping out.

Further, the medical instrument set 100 according to the present embodiment is inserted into the loading lumen 22 through any of the catheters 20 loaded with the embolus described above and the insertion passage 23a of the proximal hub 23 of the catheter 20 loaded with the embolus. a delivery pusher 30 comprising a possibly elongated pusher body 31 .

With such a configuration, the medical instrument set 100 inserts the delivery pusher 30 from the proximal end hub 23 when the catheter 20 loaded with the embolic material and the delivery catheter 40 are put into the mounting state, thereby causing the loading lumen 22 to move. The internally loaded embolus 10 can be easily pushed through the delivery catheter 40 into the aneurysm. In addition, even if the catheter 20 loaded with the embolizing material is primed with the embolizing material 10 loaded in the catheter main body 21, the unintended ejection of the embolizing material 10 can be prevented.

This application is based on Japanese Patent Application No. 2021-154164 filed on September 22, 2021, the disclosure of which is incorporated by reference in its entirety.

10 (10A-10M) emboli,
11 (11A to 11M) contact part,
20 embolized catheter,
21 catheter body (21a inner peripheral surface),
22 loading lumens,
23 base end hub (23a insertion passage),
28 fluid flow path (28a first fluid flow path, 28b second fluid flow path, 28c third fluid flow path),
30 delivery pusher;
31 pusher body,
40 delivery catheter,
50 insertion auxiliary member,
100 medical instrument set 200 delivery system,
300 Embolic Delivery Medical System.

Claims (5)

an elongated catheter body;
an embolus that swells upon contact with a liquid; and
a loading lumen provided in communication from the distal end to the proximal end of the catheter body and loaded with the embolization material;
an injection hub having an insertion passage communicating with the loading lumen and capable of injecting a fluid into the loading lumen;
with
The embolus moves on an outer peripheral surface of the embolus to contact an inner peripheral surface of the catheter body defining the loading lumen to inhibit axial movement of the embolus in the catheter body. having a plurality of contacts under restraining force,
The catheter body has an injection port for injecting the fluid into the loading lumen via the injection hub and an outlet for discharging the fluid from the loading lumen,
In the loading lumen in which the embolus is loaded and the plurality of contact portions are subjected to the movement suppressing force, the charging lumen extends from the distal end to the proximal end of the loading lumen, and the injection port and an embolus-loaded catheter defining a fluid passageway in communication with said outlet. The embolus is formed in a shape different from the inner peripheral surface of the catheter body defining the loading lumen in a cross-section in a direction orthogonal to the axial direction, so that the inner peripheral surface of the catheter body is Having a plurality of the contact portions that contact the surface,
2. The embolus-loaded material of claim 1, wherein said fluid flow path comprises at least a first fluid flow path comprising a gap formed between said inner peripheral surface of said catheter body and said outer peripheral surface of said embolus. catheter. 3. The embolus-loaded catheter of claim 1 or 2, wherein the fluid flow path comprises a second fluid flow path comprising a void formed inside the embolus at least from the proximal end to the distal end of the embolus. The plug has a linear structure extending along the axial direction of the loading lumen and having a plurality of contact portions that contact the inner peripheral surface of the catheter body,
2. The embolus-loaded catheter of claim 1, wherein said fluid flow path comprises at least a third fluid flow path comprising a void formed between said inner peripheral surface of said catheter body and said embolus. an embolus-loaded catheter according to any one of claims 1 to 4;
a delivery pusher comprising an elongated pusher body insertable into the loading lumen through a passageway in the proximal hub of the embolus-loaded catheter.

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