JP2023025420A - Sheath assembly and suction method - Google Patents

Abstract

To provide a sheath assembly and a suction method capable of reducing a burden on a puncture site and improving suction efficiency.SOLUTION: A sheath assembly 10 comprises: a sheath 20 including a sheath hub opening 28 and a valve 23 capable of connecting with a suction device 70; and a dilator 30 which can be inserted into the sheath 20. The sheath assembly 10 also comprises a sliding tube 40 having a lumen for the sheath 20 to pass therethrough and being slidable with the sheath 20.SELECTED DRAWING: Figure 1

Description

The present invention relates to a sheath assembly provided with a sheath for aspirating an object in a blood vessel and an aspiration method using the sheath assembly.

BACKGROUND ART In recent years, a technique has been performed in which a catheter is inserted into a blood vessel through the skin and a suction force is applied to the catheter to remove a thrombus or the like from the blood vessel to the outside of the body (see, for example, Patent Document 1). In order to efficiently aspirate intravascular thrombi and the like, it is preferable that the inner diameter of the aspirating catheter is large. In particular, when it is desired to remove a thrombus from a large vein, the required inner diameter of the catheter is correspondingly increased.

JP 2020-014874 A

If the diameter of the catheter for suction is increased, it is necessary to increase the hole at the puncture site from the skin to the blood vessel, increasing the burden on the patient. When a catheter for suction is inserted into a blood vessel, it is usually inserted into the blood vessel through the lumen of a sheath introducer inserted into the blood vessel through the skin. Therefore, since the diameter of the catheter for aspiration depends on the size of the catheter that can be inserted into the sheath introducer, it is difficult to ensure a large inner diameter of the catheter. Therefore, it is not easy to improve the suction force of the catheter.

SUMMARY OF THE INVENTION It is an object of the present invention to provide a sheath assembly and a suction method that can reduce the burden on the puncture site and improve the suction efficiency.

A sheath assembly according to the present invention for achieving the above object is a sheath assembly comprising a sheath provided with a port connectable to a suction instrument and a valve body, and a dilator insertable into the sheath, wherein the sheath is formed with a penetrable lumen and has a sliding tube that is slidable with the sheath.

A suction method according to the present invention for achieving the above objects is a suction method for percutaneously aspirating and removing an object in a blood vessel, wherein the blood vessel is punctured through the skin and a guide wire is inserted into the blood vessel from the puncture site. a sheath provided with a port connectable to a suction instrument and a valve body, a dilator inserted into the sheath, and a sheath assembly having a sliding tube through which the sheath passes through the guide inserted into the dilator inserting along a wire into a blood vessel; placing a distal end of the sliding tube inside the blood vessel and placing a proximal end of the sliding tube outside the body; removing the dilator and the guide wire from the sheath; connecting the suction device to a port of the sheath; and applying a suction force to the port by the suction device while moving the sheath along the sliding tube held at the puncture site in a distal direction. and alternately moving proximally to aspirate intravascular matter out of the body through the lumen of the sheath.

The sheath assembly and aspiration method configured as described above are performed by inserting the sheath assembly into the blood vessel, placing the sliding tube at the puncture site of the skin and blood vessel, and sliding the sheath along the inner surface of the sliding tube. can be moved. Therefore, even if the sheath is repeatedly moved in the distal direction and the proximal direction when the suction device is connected to the port and suction is performed, the sheath does not rub against the puncture site, and the burden on the puncture site can be reduced. Furthermore, since the sheath itself can be used for aspiration without inserting another elongated device for aspiration into the sheath, the wide lumen can be used to improve the aspiration efficiency.

FIG. 4 is a plan view showing each configuration of the sheath assembly according to the embodiment in an exploded manner; FIG. 4 is a plan view showing an assembled state of the sheath assembly according to the present embodiment; FIG. 4 is a schematic diagram showing a state in which the catheter assembly is inserted through the skin into a blood vessel; FIG. 4 is a schematic diagram showing the removal of spacers and dilators from a sheath inserted into a blood vessel; FIG. 4 is a schematic diagram showing a state in which a sheath inserted into a blood vessel is moved along a sliding tube; FIG. 4 is a schematic diagram showing a state in which a thrombus or the like is aspirated by a sheath inserted into a blood vessel; 4 is a flow chart for explaining an aspiration method using a sheath assembly;

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for convenience of explanation and may differ from the actual ratios. In the following description, the side of the sheath assembly operated by the operator is called the "proximal end", and the side of the sheath assembly inserted into the living body is called the "distal end". Further, in this specification, the range "X to Y" includes X and Y and means "X or more and Y or less". Moreover, in this specification, the “axial direction” means the direction in which the elongated member extends longitudinally.

The sheath assembly 10 according to the embodiment of the present invention is used to be inserted into a blood vessel through the skin and to aspirate an object such as a thrombus in the blood vessel to remove it from the body. A blood vessel into which the sheath assembly 10 is inserted is not particularly limited, and may be a vein or an artery.

As shown in FIGS. 1 and 2, the sheath assembly 10 includes a sheath 20 for aspirating a thrombus or the like, a dilator 30 functioning as a core material for allowing the sheath 20 to reach a target position, and a slide for sliding the sheath 20. It includes a sliding tube 40 that is movably received and a spacer 50 that holds the sliding tube 40 in place with respect to the sheath 20 .

The sheath 20 includes a flexible tubular sheath body 21 , a sheath hub 22 fixed to the proximal end of the sheath body 21 , and a valve body 23 arranged inside the sheath hub 22 . The sheath 20 in this embodiment is a guiding sheath that functions as a guiding catheter and a sheath introducer.

The sheath main body 21 is composed of a flexible tubular body, and a sheath lumen 24 is formed over the entire length of the sheath main body 21 at substantially the center thereof. The sheath lumen 24 opens at a sheath tip opening 29 at the tip of the sheath body 21 . The sheath main body 21 has a sheath base portion 25 having a substantially constant outer diameter along the axial direction, and a reduced diameter sheath portion 26 having an outer diameter that decreases from the tip of the sheath base portion 25 toward the tip side. ing.

The sheath hub 22 is fixed to the proximal end of the sheath body 21 . The sheath hub 22 has a sheath hub passageway 27 communicating with the sheath lumen 24, and the sheath hub passageway 27 opens at a proximal sheath hub opening 28 (port). The sheath hub 22 may also have a kink-resistant connector on the distal side.

The sheath hub 22 has the dilator 30 inserted through the sheath hub opening 28 in a state where the sheath 20 and the dilator 30 are connected. After the dilator 30 is removed, the sheath hub opening 28 functions as a port for removing thrombi and the like from the body by connecting an aspiration instrument 70 such as a syringe and a pump. The sheath hub opening 28 may be directly connected to a syringe, a pump, or the like, or indirectly connected to these devices via a three-way stopcock or tube, as long as it can receive a suction force.

The constituent material of the sheath body 21 is not particularly limited, but is, for example, a general resin material such as polyolefin or polyester. The sheath main body 21 may be embedded with a coil formed by spirally winding a wire or a braid formed by braiding a plurality of wires into a tubular shape as a reinforcing member. In addition, the sheath body 21 does not have to be provided with a reinforcing body.

The outer diameter of the sheath body 21 is not particularly limited, but is, for example, 6F (2.0 mm) to 15F (5.0 mm). The outer diameter of the sheath body 21 is, for example, 10F (3.3 mm) to 15F (5.0 mm) when the blood vessel is a vein, and 6F (2.0 mm) to 8F (2 mm) when the blood vessel is an artery. .7 mm). The inner diameter of the sheath body 21 is not particularly limited, but is, for example, 4F (1.3 mm) to 13F (4.3 mm). The inner diameter of the sheath body 21 is, for example, 8F (3.3 mm) to 13F (4.3 mm) when the blood vessel is a vein, and 4F (1.3 mm) to 6F (2.5 mm) when the blood vessel is an artery. 0 mm). The effective axial length of the sheath body 21 (the axial length from the tip of the sheath hub 22 to the tip of the sheath body 21) is not particularly limited, but is, for example, about 400 mm to 2000 mm. The effective axial length of the sheath body 21 is about 400 mm to 1000 mm when the blood vessel is a vein. If the blood vessel is an artery, the effective length of the sheath body 21 may be up to about 2000 mm, considering access from the radial artery to remove thrombus in the lower extremities.

The valve body 23 has a through hole penetrating from the distal side to the proximal side, is flexibly deformable, and is arranged on the inner peripheral surface of the sheath hub passage 27 . The valve body 23 allows instruments such as the dilator 30 and the guide wire 60 inserted into the through hole to slide, while suppressing leakage of fluid such as blood. Moreover, the through-hole of the valve body 23 is closed in a state in which an instrument such as the dilator 30 or the guide wire 60 is not inserted. The constituent material of the valve body 23 is not particularly limited, but examples thereof include elastic members such as silicone rubber, latex rubber, butyl rubber, and isoprene rubber.

The dilator 30 includes a dilator body 31 that can be inserted into the sheath body 21 and a dilator hub 32 fixed to the proximal end of the dilator body 31 . A dilator lumen 33 is formed in the central portion of the dilator body 31 over the entire length of the dilator body 31 . The dilator main body 31 has a dilator base portion 34 having a substantially constant outer diameter along the axial direction, and a dilator reduced diameter portion 35 having an outer diameter that decreases from the tip of the dilator base portion 34 toward the tip side. ing.

The dilator hub 32 is fixed to the proximal end of the dilator main body 31 . Dilator hub 32 has a dilator hub passageway 36 in communication with dilator lumen 33 , which opens at a proximal dilator hub opening 37 . Further, the dilator hub 32 has a connecting portion 38 that can be connected to the sheath hub 22 on the distal end side. The connecting portion 38 can be fitted over the proximal end portion of the sheath hub 22 . Note that the configuration of the connecting portion 38 is not particularly limited as long as it can be connected to the sheath hub 22 .

The constituent material of the dilator main body 31 is not particularly limited, but is, for example, a general resin material such as polyolefin or polyester.

The outer diameter of the dilator main body 31 is set smaller than the inner diameter of the sheath main body 21 . Although the inner diameter of the dilator main body 31 is not particularly limited, it is preferably 1 mm or more. The effective axial length of the dilator body 31 (the axial length from the tip of the dilator hub 32 to the tip of the dilator body 31 ) is set longer than the effective length of the sheath body 21 .

The sliding tube 40 includes a sliding tube body 41 capable of accommodating the sheath body 21 and a sliding hub 42 fixed to the proximal end of the sliding tube body 41 . A slide tube lumen 43 is formed in the center of the slide tube body 41 over the entire length of the slide tube body 41 . The slide tube main body 41 includes a slide tube base portion 44 having a substantially constant outer diameter along the axial direction, and a slide tube having a decreasing outer diameter from the tip of the slide tube base portion 44 toward the tip side. and a reduced diameter portion 45 . The sliding hub 42 is fixed to the proximal end of the sliding tube main body 41 . Sliding hub 42 has a sliding hub passageway 46 communicating with sliding tube lumen 43 and opening at a proximal sliding hub opening 47 . The sliding hub 42 also has a pair of wings 48 projecting apart from each other in a direction crossing the axial direction of the sliding tube body 41 . Each wing portion 48 is formed in a flat plate shape substantially parallel to the axial direction of the sliding tube main body 41 in a natural state where no external force acts. The two wings 48 are deformable so that their surfaces are in close contact with each other (see FIG. 3).

The constituent material of the sliding tube main body 41 is not particularly limited, but is, for example, a general resin material such as polyolefin or polyester. It is preferable that the sliding tube main body 41 has a small frictional resistance on the inner peripheral surface and a large frictional resistance on the outer peripheral surface. For this reason, for example, the sliding tube main body 41 may be formed with a multi-layer structure, and the inner layer forming the inner peripheral surface may be formed of a low-friction material. The low-friction material is, for example, fluorine-based resin such as PTFE (polytetrafluoroethylene), PFA (tetrafluoroethylene-perfluoroalkoxyethylene copolymer), or silicone resin, but is not limited to these. In addition, the sliding tube main body 41 does not have to be formed with a multi-layer structure. The sliding tube main body 41 may be coated with a low-friction material on its inner peripheral surface or may be grained to reduce the frictional resistance of the inner peripheral surface. The sliding tube main body 41 is formed of a single layer structure and may be formed of a metal material. For example, it is stainless steel.

The inner diameter of the sliding tube main body 41 is set slightly larger than the outer diameter of the sheath main body 21 described above. It is preferable that the diameter clearance between the inner peripheral surface of the sliding tube main body 41 and the outer peripheral surface of the sheath main body 21 is small enough to allow sliding. The effective axial length of the sliding tube body 41 (the axial length from the tip of the sliding hub 42 to the tip of the sliding tube body 41) is shorter than the effective length of the sheath body 21, preferably 50 mm. ~150 mm, more preferably 50-120 mm, and even more preferably 70-100 mm. As a result, when the slide tube 40 is inserted into the blood vessel through the skin, the opening at the tip of the slide tube 40 can reliably reach the inside of the blood vessel. The wall thickness of the sliding tube base 44 is preferably thin within a range in which the shape can be maintained so that it can be inserted into a puncture site that is as small as possible and the sheath 20 that is as large as possible can be inserted. The thickness of the sliding tube base 44 is equal to or less than the thickness of the sheath body 21, preferably less than the same. The thickness of the sliding tube base 44 is preferably smaller than the thickness of the tubular portion of a typical sheath introducer. Since the sliding tube 40 is used with the sheath body 21 inserted therein, it is formed so thin that it would not be able to maintain its shape when inserted into a blood vessel and would be crushed if there was no sheath body 21 inside. may be As a result, the inner diameter of the slide tube 40 can be increased while the outer diameter of the slide tube 40 is decreased.

The spacer 50 is a member that holds the sliding tube 40 at a predetermined axial position with respect to the sheath 20 . The spacer 50 is a flexible tubular body that can accommodate the sheath body 21 on the proximal end side of the sliding tube 40 . The proximal end of spacer 50 can abut the distal end of sheath hub 22 and the distal end of spacer 50 can abut the proximal end of sliding hub 42 . The inner peripheral surface of the spacer 50 is in slidable contact with the outer peripheral surface of the sheath body 21 .

The spacer 50 has two fragile portions 51 that break with a smaller force than other portions of the spacer 50, a detachable portion 52 sandwiched between the two fragile portions 51, and an operator's grip when breaking the fragile portion 51. and a grip portion 53 . The fragile portion 51 is weaker than other portions of the spacer 50 and has a structure that is easily broken. The fragile portion 51 is, for example, a perforation in which a plurality of small holes are continuously arranged. Note that the fragile portion 51 may be, for example, a groove formed thinner than other portions of the spacer 50 or may be a portion made of a material different from that of the other portions of the spacer 50 .

Two fragile portions 51 are provided and extend axially from the distal end of the spacer 50 to the proximal end. The two weakened portions 51 are circumferentially separated from each other by an angle of 180 degrees or less with respect to the central axis of the spacer 50 . The detachable portion 52 is sandwiched between two fragile portions 51 . The grip portion 53 is a portion that protrudes from the proximal end of the detachable portion 52 toward the proximal end side. Note that the grasping portion 53 may be a portion protruding from the tip of the detachable portion 52 toward the tip side. By gripping the grip portion 53 and exerting a force on the spacer 50 , the operator can break the two fragile portions 51 and break the continuity of the spacer 50 in the circumferential direction. It should be noted that breaking the continuity in the circumferential direction means that a member that has been continuously formed over 360 degrees is interrupted at any position in the circumferential direction.

A diametrical clearance between the inner peripheral surface of the spacer 50 and the outer peripheral surface of the sheath body 21 is preferably small enough to allow sliding.

The axial length of the spacer 50 is set so that the sliding tube 40 can be arranged at an appropriate position in the axial direction with respect to the sheath 20 .

The constituent material of the spacer 50 is not particularly limited, but may be, for example, a general resin material such as polyolefin or polyester, or a material other than resin.

In the assembled state shown in FIG. 2, the connecting portion 38 of the dilator 30 is connected to the sheath hub 22, and the sheath body 21 is inserted into the slide tube 40 and the spacer 50. As shown in FIG. In the assembled state, at least part of the proximal end surface of the spacer 50 contacts the distal end surface of the sheath hub 22 , and at least part of the distal end surface of the spacer 50 contacts the proximal end surface of the sliding hub 42 . In this state, the proximal end of the dilator reduced-diameter portion 35 is located on the distal side of the distal end of the sheath reduced-diameter portion 26 . The axial separation distance L1 between the proximal end of the dilator reduced diameter portion 35 and the distal end of the sheath reduced diameter portion 26 is preferably close to 0 mm and not too large. In addition, the proximal end of the sheath reduced diameter portion 26 is located on the distal side of the distal end of the slide tube reduced diameter portion 45 . The axial separation distance L2 between the proximal end of the sheath reduced diameter portion 26 and the distal end of the slide tube reduced diameter portion 45 is preferably close to 0 mm and not too large. Since the distances L1 and L2 are small, the sheath assembly 10 can be smoothly inserted from the puncture site into the blood vessel. When the separation distances L1 and L2 are 0 mm, the dilator reduced-diameter portion 35, the sheath reduced-diameter portion 26, and the sliding tube reduced-diameter portion 45 are arranged continuously without gaps in the axial direction, which enables smoother insertion. Become. The separation distance L2 may be smaller than the separation distance L1. Since the sliding tube 40 is thin, the distal end tends to curl when it is inserted into a blood vessel. It can be inserted into the body and the occurrence of curling can be suppressed. Moreover, the separation distance L2 may be larger than the separation distance L1. Since the sliding tube 40 is thin, the distal end of the sliding tube 40 tends to curl up when it is inserted into a blood vessel. can be suppressed from being disposed on the distal side of the proximal end of the sheath reduced diameter portion 26 . This reduces the possibility that the distal end of the sliding tube 40 will turn over when the sliding tube 40 is inserted into the blood vessel.

Next, a method of using the sheath assembly 10 according to this embodiment will be described with reference to the flowchart shown in FIG.

First, before introducing the sheath assembly 10 into the blood vessel, the sheath assembly 10 is brought into the assembled state shown in FIG. Thereby, the sheath 20, the dilator 30 and the sliding tube 40 can be operated integrally when inserting the sheath assembly 10 into the blood vessel.

Next, the operator punctures the blood vessel V through the skin S by a known method, and inserts the guide wire 60 into the blood vessel V from the puncture site as shown in FIG. 3 (step S1). Subsequently, the sheath assembly 10 is inserted into the blood vessel V while the guide wire 60 is led (step S2). At this time, the sheath assembly 10 is directly inserted into the puncture site without using the sheath introducer. The operator can hold the two wing portions 48 of the sliding tube 40 deformed and overlapped so as to be sandwiched between the fingers. This makes it easier for the operator to operate the sliding hub 42 . Note that the operator may operate the sheath assembly 10 without holding the wings 48 . Spacer 50 maintains the position of the proximal end of slide hub 42 relative to the distal end of sheath hub 22 as sheath assembly 10 is pushed distally. Therefore, the spacer 50 can effectively transmit the pushing force acting on the sheath hub 22 or the dilator hub 32 toward the distal direction to the slide tube 40 . It should be noted that the spacer 50 cannot transmit the withdrawal force to the slide tube 40 when the withdrawal force in the proximal direction is applied to the sheath hub 22 or the dilator hub 32 . Therefore, when applying a pull-out force in the proximal direction to the sheath hub 22 or the dilator hub 32, the operator directly applies the pull-out force in the proximal direction to the sliding tube 40 with a finger or the like. is preferred.

When inserting the sheath assembly 10 into the blood vessel V, as shown in FIG. Portions 45 are maintained side-by-side with appropriate separation distances L1 and L2. Therefore, the distal end of the sheath assembly 10 is smoothly inserted into the blood vessel V as shown in FIG. When the separation distances L1 and L2 are close to 0 mm, the dilator reduced-diameter portion 35, the sheath reduced-diameter portion 26, and the sliding tube reduced-diameter portion 45 can be smoothly inserted into the blood vessel V integrally. Note that the distances L1 and L2 do not necessarily need to be close to 0 mm, and may be relatively long distances.

Since the slide hub 42 is arranged on the proximal end side of the slide tube 40 , the proximal end portion of the slide tube 40 is not inserted into the blood vessel V. Therefore, while the distal end of the sliding tube 40 is inserted into the blood vessel V, the proximal end of the sliding tube 40 is placed outside the body (step S3). With the tip of the sliding tube 40 securely inserted into the blood vessel V, the operator removes the spacer 50 as shown in FIG. 4 (step S4). By grasping and pulling the grasping portion 53 with fingers, the operator can break the two fragile portions 51 and separate the detachable portion 52 from the spacer 50 . Thereby, the continuity of the spacer 50 in the circumferential direction is cut off. Therefore, the spacer 50 can be removed from the sheath body 21 while the sheath 20 is inserted into the sliding tube 40 . As a result, the sheath 20 can be moved distally with respect to the sliding tube 40 .

With the tip of the sliding tube 40 securely inserted into the blood vessel V, the operator spreads the two overlapped wings 48 and brings them into contact with the surface of the skin S, as shown in FIG. In this state, the operator can fix the two wings 48 to the skin S with, for example, the adhesive tape 80 (step S5). Thereby, the slide tube 40 is fixed to the skin S, and the burden on the patient due to the movement of the slide tube 40 with respect to the puncture site can be reduced. Note that the fixing of the slide tube 40 to the skin S may be performed before removing the spacer 50 . Fixation of the sliding tube 40 to the skin S is not limited to fixation with the adhesive tape 80, and may be fixed by tightening with a band, for example. Also, the fixing of the sliding tube 40 to the skin S may be performed by the sliding tube main body 41 instead of the sliding hub 42 .

After that, while leading the guide wire 60, the operator moves the sheath 20 to which the dilator 30 is connected to the distal side to reach the target position. Since the sheath 20 has the dilator 30 inserted therein, it is possible to reach the target position even if the sheath 20 has a thin structure that makes it difficult to transmit the pushing force in order to secure a wide lumen. Thereafter, the operator removes the connecting portion 38 of the dilator 30 from the sheath hub 22 and pulls out the dilator 30 and the guide wire 60 (step S6). At this time, since the valve body 23 is closed, leakage of blood from the sheath hub opening 28 can be suppressed. Subsequently, the operator connects a suction device 70 such as a syringe or a pump to the sheath hub opening 28, which is a port, as shown in FIG. 6 (step S7). The suction instrument 70 may be indirectly connected to the sheath hub opening 28 via a three-way stopcock or other tube.

Next, the operator applies a suction force with the suction device 70 while alternately reciprocating the sheath 20 in the distal direction and the proximal direction within the target blood vessel V (step S8). As a result, the thrombus or the like in the blood vessel V is sucked into the sheath lumen 24 through the sheath tip opening 29 and discharged from the sheath hub opening 28 into the suction instrument 70 . At this time, the slide tube 40 is in contact with the puncture site of the blood vessel V and the skin S, and the sheath 20 slides inside the slide tube 40, so that the puncture site of the blood vessel V and the skin S is not contacted. . The sliding tube 40 is fixed to the skin S. For this reason, even if the sheath 20 repeats reciprocating movement, it is possible to suppress the occurrence of complications such as hematoma due to rubbing against the blood vessel V and the skin S, tearing of the blood vessel V, and the like. Since the slide tube 40 is formed thin, the hole at the puncture site can be prevented from being made too large, thereby reducing the burden on the patient. Moreover, since the sliding tube 40 is formed thin, a large inner diameter of the sheath 20 can be ensured, and the suction efficiency can be improved.

After the aspiration of the thrombus etc. is completed, the operator removes the aspiration instrument 70 from the sheath hub opening 28 . At this time, since the valve body 23 is closed, leakage of blood from the sheath hub opening 28 can be suppressed. Thereafter, the operator releases the fixing of the sliding tube 40 by the adhesive tape 80, and removes the sliding tube 40 and the sheath 20 from the body (step S9). This completes the procedure of aspirating and removing the thrombus or the like.

As described above, the sheath assembly 10 according to the present embodiment includes the sheath 20 having the port connectable to the suction instrument 70 and the valve body 23, and the dilator 30 insertable into the sheath 20. and has a sliding tube 40 formed with a lumen through which the sheath 20 penetrates and which is slidable with the sheath 20 .

The sheath assembly 10 configured as described above is inserted into the blood vessel V, the sliding tube 40 is placed at the puncture site of the skin S and the blood vessel V, and the sheath 20 is inserted into the sliding tube 40. It can be slid along the inner surface. Therefore, even when the sheath 20 is repeatedly moved in the distal direction and the proximal direction when the suction device 70 is connected to the port and suction is performed, the sheath 20 does not rub against the puncture site, and the burden on the puncture site can be reduced. Furthermore, since the sheath 20 itself can be used for aspiration without inserting another elongated device for aspiration into the sheath 20, the wide lumen can be used to improve the aspiration efficiency.

The thickness of the sliding tube 40 is equal to or less than the thickness of the sheath body 21, preferably less than the same. As a result, the hole of the puncture site into which the sliding tube 40 can be inserted can be made small while ensuring a large diameter of the sheath 20 that can be accommodated inside the sliding tube 40 . Therefore, the wide lumen of the sheath 20 can be used to improve the suction efficiency, and the hole at the puncture site can be made smaller to reduce the burden on the living body.

Also, the distal end of the sliding tube 40 can be arranged at the proximal end of the sheath 20 . The axial length of the sheath body 21 is usually 400 mm to 2000 mm, whereas the axial length of the sliding tube 40 is preferably less than half the length of the sheath body 21 . As a result, a sufficient length for moving the sheath body 21 in the axial direction is secured inside the manual tube 40 . When the sheath main body 21 is moved to the most distal side with respect to the sliding tube 40 , the distal end of the sliding tube 40 is the base end of the sheath 20 , that is, half the length of the sheath 20 in the axial direction. It is located proximal to the position.

The sliding tube 40 includes a sliding tube main body 41 which is a flexible tubular body, and a sliding hub opening 47 fixed to the proximal end of the sliding tube main body 41 and communicating with the inner cavity of the sliding tube main body 41 . has a sliding hub 42 formed thereon. Thereby, when the sheath 20 is reciprocated in the distal direction and the proximal direction, the sliding hub 42 can be used so that the sliding tube 40 does not leave the puncture site. In addition, by providing the slide hub 42, it is possible to prevent the entire slide tube 40 from entering the body.

The sliding hub 42 also has a pair of wings 48 projecting apart from each other in a direction crossing the axial direction of the sliding tube body 41 . This makes it easier for the operator to hold and operate the wings 48 with their fingers. Wings 48 may also be used to secure the sliding hub 42 to the skin S of the patient.

The sheath assembly 10 also has a spacer 50 that holds the sliding tube 40 in place axially with respect to the sheath 20 . As a result, the sheath assembly 10 can be integrally inserted into the blood vessel V while the sliding tube 40 is held at a predetermined position on the sheath 20 . Therefore, the operability of the sheath assembly 10 is improved.

Also, the effective length of the sliding tube 40 that can be inserted into the living body is 50 to 100 mm. If the effective length of the sliding tube 40 is too long, it becomes difficult to insert the sliding tube 40 into the blood vessel V, and sliding resistance with the sheath 20 increases. If the effective length of the sliding tube 40 is too short, it will be difficult to reach the blood vessel V from the skin S. When the effective length of the sliding tube 40 is within an appropriate range, the sliding tube 40 can be easily inserted into the blood vessel V, can reach a desired position in the blood vessel V, and has reduced sliding resistance with the sheath 20. to improve operability.

The present invention also includes a suction method for removing an object such as a thrombus in the blood vessel V to the outside of the body. The suction method includes step S1 of puncturing the blood vessel V through the skin S and inserting the guide wire 60 into the blood vessel V from the puncture site, and a port (sheath hub opening 28) connectable to the suction instrument 70 and the valve body 23. A step of inserting the sheath assembly 10 having the sheath 20 provided with the sheath 20, the dilator 30 inserted into the sheath 20, and the sliding tube 40 through which the sheath 20 penetrates into the blood vessel V along the guide wire 60 inserted into the dilator 30. S2, step S3 of placing the distal end of the sliding tube 40 inside the blood vessel V and placing the proximal end of the sliding tube 40 outside the body, step S6 of removing the dilator 30 and the guide wire 60 from the sheath 20, Step S7 of connecting the suction device 70 to the port 20, and while applying suction force to the port by the suction device 70, the sheath 20 is alternately moved distally and proximally along the sliding sheath 20 held at the puncture site. and a step S8 of aspirating the object in the blood vessel V through the lumen of the sheath 20 to the outside of the body.

In the aspiration method configured as described above, an object in the blood vessel V can be aspirated out of the body through the sheath 20 while moving the sheath 20 along the sliding sheath 20 held at the puncture site. It is possible to reduce the burden on the puncture site when reciprocating. Furthermore, since the sheath 20 itself can be used as a tube for suction without inserting another tube for suction into the sheath 20, suction efficiency can be improved by utilizing a wide lumen.

The present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical concept of the present invention. For example, in the embodiments described above, the sheath 20 is a guiding sheath, but it could also be an introducer sheath. At least one of the sheath body 21, the dilator body 31, the sliding tube body 41, or the spacer 50 may be curved.

10 sheath assembly 20 sheath 21 sheath body 22 sheath hub 23 valve body 24 sheath lumen 26 sheath reduced diameter portion 28 sheath hub opening (port)
29 Sheath tip opening 30 Dilator 35 Dilator reduced diameter portion 40 Sliding tube 41 Sliding tube main body 42 Sliding hub 43 Sliding tube lumen 45 Sliding tube reduced diameter portion 48 Wing 50 Spacer 70 Suction instrument L1, L2 Spacing Distance S Skin V Blood vessel

Claims (8)

A sheath assembly having a sheath provided with a port connectable to a suction instrument and a valve body, and a dilator insertable into the sheath,
A sheath assembly having a sliding tube formed with a lumen through which the sheath passes and which is slidable with the sheath. The sheath assembly of Claim 1, wherein the distal end of the sliding tube is positionable at the proximal end of the sheath. 3. The sheath assembly according to claim 1, wherein the thickness of said sliding tube is equal to or less than the thickness of said sheath. The slide tube includes a slide tube body that is a flexible tubular body, and a slide hub that is fixed to the proximal end of the slide tube body and has an opening that communicates with the inner cavity of the slide tube body. The sheath assembly according to any one of claims 1 to 3, comprising: The sheath assembly according to any one of claims 1 to 4, wherein the sliding hub has a pair of wing portions projecting away from each other in a direction crossing the axial direction of the sliding tube body. A sheath assembly according to any one of claims 1 to 5, comprising a spacer that holds the sliding tube in place axially with respect to the sheath. The sheath assembly according to any one of claims 1 to 6, wherein the sliding tube has an effective length that can be inserted into a living body of 50 to 100 mm. An aspiration method for percutaneously aspirating and removing an intravascular object,
puncturing a blood vessel through the skin and inserting a guidewire into the blood vessel from the puncture site;
A sheath assembly having a port connectable to a suction instrument and a valve body, a dilator inserted into the sheath, and a sliding tube through which the sheath penetrates is passed along the guide wire inserted into the dilator. inserting into a blood vessel;
placing a distal end of the sliding tube inside a blood vessel and a proximal end of the sliding tube outside the body;
withdrawing the dilator from the sheath;
connecting the suction instrument to a port of the sheath;
While applying a suction force to the port by the suction device, the sheath is alternately moved in the distal direction and the proximal direction along the sliding sheath held at the puncture site, so that the aspirating an intravascular object out of the body.

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