Device

Abstract

To provide a new device for removing a target object containing at least one of blood clot or foreign substance, from an inside of a blood vessel.SOLUTION: A device includes a tubular part, an expansion part, and a capture part. The tubular part is a tubular portion inserted into a blood vessel. The expansion part is configured to expand in a radial direction at a distal side inside the blood vessel. The capture part is a cylindrical portion inserted on a proximal side inside the blood vessel through the tubular part. The capture part opening at least at an end part on a target object side. The expansion part expands on a distal side inside the blood vessel to press against the target object up to the capture part. The capture part is configured to expand in a radial direction when inserted into the blood vessel through the tubular part, and form a net-like peripheral wall. In a state where the target object pressed by the expansion part is captured inside from the opening end part, the capture part is configured to retract into the tubular part while radially shrinking and axially expanding.SELECTED DRAWING: Figure 7

Description

[Technical Field]

[0001] The present disclosure relates to a device for removing an object, including at least one of a thrombus and a foreign body, from within a blood vessel. [Background technology]

[0002] With the development of intravascular surgery, various devices for use in intravascular surgery have been proposed. For example, Patent Document 1 proposes a device for removing blood clots from blood vessels. The device described in Patent Document 1 includes a catheter, a pressure delivery device, and a retrieval element. The pressure delivery device operates to apply suction fluid pressure through the catheter to a position proximal to the blood clot. The retrieval element is configured to capture the blood clot. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent Publication No. 2021-69950 Summary of the Invention [Problem to be solved by the invention]

[0004] One aspect of the present disclosure preferably provides a novel device for removing objects, including thrombi and / or foreign bodies, from within a blood vessel. [Means for solving the problem]

[0005] One aspect of the present disclosure is a device for removing an object, including at least one of a thrombus and a foreign body, from a blood vessel. The device includes a tubular portion, an expansion portion, and a capturing portion. The tubular portion is tubular. The tubular portion is inserted into a blood vessel. The expansion portion is configured to expand radially on a distal side farther from the tubular portion than the object in the blood vessel. The capturing portion is cylindrical. The capturing portion is inserted through the tubular portion to a proximal side closer to the tubular portion than the object in the blood vessel. The capturing portion has an open end at least on the object-side. The expansion portion is configured to expand on the distal side within the blood vessel and press the object against the capturing portion. The capturing portion is configured to expand radially when inserted into the blood vessel through the tubular portion and form a mesh-like peripheral wall. The capturing portion is configured to contract radially and stretch axially when it captures the object pressed by the expansion portion from the open end, and to be pulled back into the tubular portion.

[0006] This configuration provides a novel device for removing an object from within a blood vessel.

[0007] One aspect of the present disclosure may further include a covering configured to be able to house the capture unit therein. The covering may be provided with a first communication portion and a second communication portion. The first communication portion forms a first opening that communicates between the inside and outside of the covering. The second communication portion forms a second opening that communicates between the inside and outside of the covering. The first communication portion may be attached to the capture unit. The second communication portion may be configured so that the second opening can be switched between an open state and a closed state.

[0008] This configuration makes it easier to remove the target object from the blood vessel.

[0009] In one aspect of the present disclosure, the capture part may be open on both ends, one on the object side and the other on the opposite side. With this configuration, it is possible to capture the object in the capture part with even less force.

[0010] In one aspect of the present disclosure, the length of the capturing portion in the expanded state may be longer than the length of the target object, which reduces the number of times the target object must be captured by the capturing portion and removed from the body.

[0011] In one aspect of the present disclosure, the expansion portion may be a Fogarty balloon. With this configuration, it is possible to reduce the load on the blood vessel when the expansion portion is expanded.

[0012] According to an aspect of the present disclosure, the device may further include a suction device configured to suction fluid from the blood vessel through the tubular portion, which can further facilitate removal of the target object from the blood vessel. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is a plan view of the device according to the first embodiment. [Figure 2] FIG. 2 is a perspective view of the stent assembly according to the first embodiment. [Figure 3] 3A and 3B are plan views of a stent assembly according to a first embodiment, in which the stent is contracted in a radial direction, and in which the stent is expanded in a radial direction. [Figure 4] Fig. 4A is a cross-sectional view showing a state in which a balloon catheter is inserted into a blood vessel during thrombus removal surgery using the device according to the first embodiment. Fig. 4B is a cross-sectional view showing the state subsequent to Fig. 4A during thrombus removal surgery using the device according to the first embodiment. [Figure 5] Fig. 5A is a cross-sectional view showing a state in which a balloon is expanded in a thrombus removal surgery using the device according to the first embodiment, and Fig. 5B is a cross-sectional view showing a state in which a stent is inserted into a blood vessel in a thrombus removal surgery using the device according to the first embodiment. [Figure 6]Fig. 6A is a cross-sectional view showing a state in which a balloon is pressing against a thrombus in a thrombus removal surgery using the device according to the first embodiment. Fig. 6B is a cross-sectional view showing a state subsequent to Fig. 6A in a thrombus removal surgery using the device according to the first embodiment. [Figure 7] Fig. 7A is a cross-sectional view showing a state in which a stent is being pulled back into a sheath in a thrombus removal surgery using the device according to the first embodiment. Fig. 7B is a cross-sectional view showing a state subsequent to Fig. 7A in a thrombus removal surgery using the device according to the first embodiment. [Figure 8] FIG. 8 is a cross-sectional view showing a state in which the aspirator is aspirating fluid from inside a blood vessel during thrombus removal surgery using the device according to the first embodiment. [Figure 9] FIG. 9 is a perspective view of a stent assembly according to the second embodiment. [Figure 10] Fig. 10A is a perspective view of a stent according to a second embodiment, and Fig. 10B is a perspective view of a cover according to the second embodiment. [Figure 11] Fig. 11A is a cross-sectional view showing a state in which a stent is inserted into a blood vessel during thrombus removal surgery using the device according to the second embodiment. Fig. 11B is a cross-sectional view showing a state in which a balloon presses against a thrombus during thrombus removal surgery using the device according to the second embodiment. [Figure 12] FIG. 12 is a cross-sectional view showing a state in which a stent is being pulled back into a sheath in a thrombus removal surgery using the device according to the second embodiment. [Figure 13] FIG. 13 is a perspective view for explaining deformation of the cover body in a thrombus removal surgery using the device according to the second embodiment. [Figure 14] Fig. 14A is a cross-sectional view showing the state subsequent to Fig. 12 in a thrombus removal surgery using the device according to the second embodiment. Fig. 14B is a cross-sectional view showing the state subsequent to Fig. 14A in a thrombus removal surgery using the device according to the second embodiment. [Figure 15]FIG. 15 is a perspective view for explaining the cover body in which the second opening has been changed to a closed state in a thrombus removal surgery using the device according to the second embodiment. [Figure 16] Fig. 16A is a cross-sectional view for explaining a modified example of thrombus removal surgery using the device according to embodiment 1. Fig. 16B is a cross-sectional view showing the state subsequent to Fig. 16A in the modified example of thrombus removal surgery using the device according to embodiment 1. DETAILED DESCRIPTION OF THE INVENTION

[0014] Hereinafter, exemplary embodiments of the present disclosure will be described with reference to the drawings.

[0015] [1. First embodiment] [1-1.Configuration] FIG. 1 shows a device 1 for removing an object from inside a blood vessel. The object includes at least one of a thrombus X shown in FIG. 4A and a foreign body. The thrombus X is a solid material containing a fibrous component such as fibrin and a gel-like component such as blood cells. The thrombus X is a type of embolic substance that clogs a blood vessel. The foreign body is a substance that can become an embolic substance. Specific examples of foreign bodies include atheroma and hematoma.

[0016] As shown in FIG. 1, the device 1 includes a sheath assembly 2 , a balloon catheter 3 , a stent assembly 4 , and an aspirator 5 .

[0017] The sheath assembly 2 is a member for introducing the balloon catheter 3 and the stent assembly 4 into a blood vessel. The sheath assembly 2 includes a sheath 21, a hub 22, a tube 23, and a three-way stopcock 24.

[0018] The sheath 21 is a flexible tubular portion. The sheath 21 is made of a biocompatible polymer. Specific examples of biocompatible polymers include polytetrafluoroethylene, polyamide, silicone, polyvinyl chloride, polyurethane, polyethylene, and polypropylene. The sheath 21 is configured to be insertable into a blood vessel. The sheath 21 is inserted into the blood vessel with one end 21a in the axial direction as the leading end. Hereinafter, the front side and rear side in the insertion direction into the blood vessel will be simply referred to as the front side and rear side, respectively. The front end 21a and rear end 21b of the sheath 21 correspond to both ends 21a, 21b of the sheath 21 in the axial direction.

[0019] The hub 22 has a hub body 221, a valve body 222, and a port 223. The hub 22 is made of a polymer.

[0020] The hub body 221 is a cylindrical portion. One axial end of the hub body 221 is connected to the rear end 21b of the sheath 21. The inner cavity of the hub body 221 communicates with the inner cavity of the sheath 21.

[0021] The valve element 222 closes the other axial end of the hub body 221 (i.e., the end opposite the sheath 21 side). The valve element 222 is configured to be able to prevent blood from leaking out of the body via the hub body 221 when the sheath 21 is inserted into a blood vessel. On the other hand, the valve element 222 is configured to allow the balloon catheter 3 and the stent assembly 4 to be inserted into the lumen of the hub body 221. A specific structure of the valve element 222 may include, for example, a structure in which a slit that reaches only the outer surface of the valve element 222 and a slit that reaches only the inner surface of the valve element 222 are formed, and these slits partially intersect within the wall of the valve element 222. The balloon catheter 3 and the stent assembly 4 are inserted into the lumen of the hub body 221 through these slits.

[0022] Port 223 is a cylindrical portion provided on the outer circumferential surface of hub body 221. The inner cavity of port 223 communicates with the inner cavity of hub body 221.

[0023] The tube 23 is a flexible tubular member. One axial end of the tube 23 is connected to the port 223. The inner cavity of the tube 23 communicates with the inner cavity of the hub body 221 via the port 223. Therefore, the inner cavity of the tube 23 communicates with the inner cavity of the sheath 21 via the hub 22.

[0024] The three-way stopcock 24 is attached to the other axial end of the tube 23 (i.e., the end opposite to the hub 22 side). The three-way stopcock 24 is configured to be switchable between a state in which the lumen of the tube 23 is closed at that end and a state in which the lumen of the tube 23 is connected to the outside of the tube 23 at that end.

[0025] The balloon catheter 3 is a member configured to be insertable into a blood vessel through the sheath 21. The balloon catheter 3 includes a catheter 31, a balloon 32, and a guide wire 33.

[0026] The catheter 31 is a rod-shaped part. The catheter 31 is flexible. The catheter 31 is made of a biocompatible resin.

[0027] Although not shown, the catheter 31 has a first lumen and a second lumen formed inside. The first lumen is a space that continues from the rear end hole 311 to the first side hole 312. The second lumen is a space that continues from the second side hole 313 to the tip hole 314. The rear end hole 311 is a hole formed in the rear end 31b of the catheter 31. The tip hole 314 is a hole formed in the front end 31a of the catheter 31. The front end 31a and the rear end 31b of the catheter 31 correspond to both ends 31a, 31b of the catheter 31 in the axial direction. The first side hole 312 and the second side hole 313 are holes formed in the peripheral wall of the catheter 31. The first side hole 312 and the second side hole 313 are located between the rear end hole 311 and the tip hole 314. The second side hole 313 is disposed on the rear side of the first side hole 312 (that is, on the rear end hole 311 side).

[0028] The balloon 32 is disposed so as to surround the outer periphery of the catheter 31, and is a part that forms a closed space between the balloon 32 and the catheter 31. The balloon 32 is disposed so as to surround an area including the first side hole 312 in the catheter 31.

[0029] The balloon 32 is made of a biocompatible resin. The balloon 32 is flexible. The balloon 32 is configured to be radially expandable and contractible. Specifically, when a fluid flows into the balloon 32 from the first side hole 312 via the first lumen of the catheter 31, the balloon 32 expands radially. The fluid flowing into the balloon 32 may be, for example, a gas such as air or a liquid such as sterile water. The balloon 32 is a so-called Fogarty balloon, which expands radially more as the amount of fluid flowing in increases. When the fluid is discharged from the balloon 32 via the first lumen, the balloon 32 contracts radially and returns to its original shape.

[0030] The guidewire 33 is made of a wire made of a biocompatible metal. Specific examples of biocompatible metals include nickel-titanium alloy (nitinol), cobalt-chromium alloy, and stainless steel. The guidewire 33 is inserted into the second lumen of the catheter 31 from the second side hole 313. The guidewire 33 is configured to be movable axially through the second lumen of the catheter 31. Note that FIG. 1 shows the guidewire 33 extended from the tip hole 314 to the outside of the catheter 31. The balloon catheter 3 is a so-called rapid exchange type.

[0031] With the balloon 32 in a radially contracted state, the balloon catheter 3 is inserted, with the front end 31a of the catheter 31 in the lead, through the valve body 222 of the hub 22 and into the sheath 21. With the sheath 21 inserted into the blood vessel, the balloon catheter 3 is inserted through the sheath 21 into the blood vessel.

[0032] The stent assembly 4 is a member configured to be insertable into a blood vessel through the sheath 21. The stent assembly 4 is biocompatible. The stent assembly 4 is made of, for example, metal. As shown in FIG. 2 , the stent assembly 4 includes a stent 41 and a shaft 42.

[0033] The stent 41 is a tubular member configured to be expandable and contractible in the radial direction. The stent 41 of this embodiment is cylindrical. Both ends 41a, 41b of the stent 41 in the axial direction are open. The diameter of the stent 41 is constant in the axial direction. The stent 41 is flexible.

[0034] The stent 41 has a circumferential wall 411 that is continuous around its central axis. The circumferential wall 411 is mesh-like at least when the stent 41 is radially expanded. In this embodiment, the circumferential wall 411 is mesh-like even when the stent 41 is radially contracted, as shown in FIG. 3A .

[0035] When a compressive force is applied in the radial direction, the stent 41 is in a radially contracted state as shown in FIG. 3A. When the compressive force is released from this state, the stent 41 radially expands as shown in FIG. 3B. The stent 41 is a so-called self-expanding type. The diameter D of the stent 41 in the radially expanded state is set according to the size of the blood vessel to which the device 1 is applied. The diameter D of the stent 41 is designed, for example, so that the stent 41 comes into contact with the inner wall of the blood vessel when expanded within the blood vessel. In other words, the diameter D of the stent 41 is designed, for example, to be the same as or slightly larger than the diameter of the blood vessel into which the stent 41 is inserted.

[0036] As shown in FIGS. 3A and 3B, when the compressive force is released, the stent 41, more specifically, expands radially and contracts axially. The length L2 of the stent 41 in the radially expanded state is shorter than the length L1 of the stent 41 in the radially contracted state. The lengths L1 and L2 of the stent 41 refer to dimensions along the axial direction of the stent 41. Furthermore, the length L2 of the stent 41 in the radially expanded state is longer than the length of an object in a blood vessel to which the device 1 is applied. The length of the object in a blood vessel refers to the dimension of the object along the direction of blood flow in the blood vessel. For example, when the device 1 is applied to a thrombus X shown in FIG. 4A, the stent 41 is designed so that the length L2 of the stent 41 in the radially expanded state is longer than the length Lx of the thrombus X.

[0037] When a compressive force is applied to the stent 41 in the radially expanded state shown in Fig. 3B, the stent 41 contracts in the radial direction as shown in Fig. 3A. More specifically, when a compressive force is applied to the stent 41 in the radial direction, the stent 41 contracts in the radial direction and extends in the axial direction.

[0038] 2, the shaft 42 is a rod-shaped portion. The shaft 42 extends from the rear end 41b of the stent 41 along the axial direction of the stent 41. The shaft 42 is flexible.

[0039] 1, the stent assembly 4 is inserted into the sheath 21, with the stent 41 in the radially contracted state, through the valve body 222 of the hub 22, with the stent 41 at the forefront. When the sheath 21 is inserted into the blood vessel, the stent assembly 4 is inserted into the blood vessel through the sheath 21. When the stent 41 is inserted into the blood vessel through the sheath 21 (i.e., when the stent 41 is exposed from the sheath 21), the stent 41 is released from the compressive force of the sheath 21 and expands radially within the blood vessel.

[0040] The aspirator 5 is configured to be capable of suction. The aspirator 5 may be, for example, a device such as an electrically controlled suction pump, or may be an instrument such as a syringe that is manually operated for suction. The aspirator 5 is connected to a three-way stopcock 24. With the sheath 21 inserted into the blood vessel, the aspirator 5 is configured to aspirate fluid from within the blood vessel via the sheath 21, the hub 22, the tube 23, and the three-way stopcock 24.

[0041] [1-2. Effect] The following describes the operation of the device 1 when it is used in a thrombus removal operation to remove a thrombus X shown in Fig. 4A from inside a blood vessel V. The thrombus X corresponds to an example of a target object.

[0042] First, as shown in Fig. 4A, the sheath 21 is inserted into the blood vessel V. The sheath 21 is advanced within the blood vessel V until its front end 21a reaches a position just before the thrombus X and spaced apart from the thrombus X. When the front end 21a of the sheath 21 reaches this position, the rear end 21b of the sheath 21 is located outside the body.

[0043] Next, with the balloon 32 in a radially contracted state, the balloon catheter 3 is inserted into the sheath 21 with the front end 31a of the catheter 31 in the lead. The balloon catheter 3 is then inserted through the sheath 21 into the blood vessel V. As shown in FIG. 4B , the balloon catheter 3 is advanced within the blood vessel V until the balloon 32 reaches a position beyond the thrombus X. In other words, the balloon 32 is inserted distally within the blood vessel V. The distal side within the blood vessel V refers to the side of the blood vessel V that is farther from the sheath 21 than the thrombus X, as shown in FIG. 4A . With the balloon 32 inserted distally within the blood vessel V, the rear end 31b of the catheter 31 is located outside the body.

[0044] 5A, fluid is introduced into the balloon 32, causing the balloon 32 to expand radially on the distal side within the blood vessel V. The balloon 32 expands until it comes into contact with the inner wall of the blood vessel V over the entire circumference.

[0045] Next, as shown in FIG. 5B , the stent assembly 4 is inserted into the sheath 21 with the stent 41 at the front. At this time, the stent 41 is subjected to a compressive force by the sheath 21 and is in a radially contracted state. The stent assembly 4 is then inserted into the blood vessel V through the sheath 21. As the stent assembly 4 is inserted into the blood vessel V through the sheath 21, the portion of the stent 41 exposed from the sheath 21 is released from the compressive force of the sheath 21 and expands radially. This portion then comes into contact with the inner wall of the blood vessel V over its entire circumference. This portion forms a mesh-like peripheral wall 411.

[0046] The stent assembly 4 is advanced within the blood vessel V until the front end 41a of the stent 41 reaches a position just before the thrombus X. In other words, the stent 41 is inserted proximally within the blood vessel V. As shown in FIG. 4A, the proximal side within the blood vessel V refers to the side of the blood vessel V that is closer to the sheath 21 than the thrombus X. As shown in FIG. 5B, when the stent 41 is inserted proximally within the blood vessel V, the front end 41a and the rear end 41b of the stent 41 correspond to the end 41a of the stent 41 on the thrombus X side and the end 41b on the opposite side.

[0047] When inserted proximally into blood vessel V, the stent 41 is in a state where most of it is exposed from the sheath 21 and is expanded in the radial direction. However, the rear end 41b of the stent 41 is located inside the sheath 21. The rear end 41b of the stent 41 is still subjected to a compressive force by the sheath 21 and is therefore in a state where it is contracted in the radial direction.

[0048] 6A, the balloon catheter 3 is pulled back while the balloon 32 remains in a radially expanded state. As the balloon catheter 3 is pulled back, the balloon 32 in a radially expanded state comes into contact with the thrombus X. Then, as the balloon catheter 3 is further pulled back, the balloon 32 in a radially expanded state presses the thrombus X toward the sheath 21.

[0049] 6B, the balloon catheter 3 is pulled back until the balloon 32 presses against the thrombus X and causes the thrombus X to enter the interior of the stent 41 from the front end 41a. That is, the balloon 32 is configured to radially expand on the distal side within the blood vessel V and press the thrombus X up to the stent 41.

[0050] In this embodiment, the length L2 of the stent 41 in the radially expanded state shown in Fig. 3B is longer than the length Lx of the thrombus X shown in Fig. 4A. Therefore, as shown in Fig. 6B, the stent 41 can capture not only a portion of the thrombus X but the entire thrombus X at once.

[0051] 7A, with the stent 41 capturing the thrombus X therein, the stent assembly 4, and therefore the stent 41, are pulled back. A compressive force is applied to the stent 41 in the radial direction from the portion of the stent 41 that has been pulled back into the sheath 21, causing the stent 41 to contract in the radial direction and expand in the axial direction. In other words, with the stent 41 capturing the thrombus X therein, the stent 41 is configured to be able to be pulled back into the sheath 21 while contracting in the radial direction and expanding in the axial direction.

[0052] As the stent 41 contracts radially and expands axially, the thrombus X captured by the stent 41 also contracts radially and expands axially. Then, as shown in Fig. 7B, at least the fibrous components contained in the thrombus X are collected together with the stent 41 into the sheath 21 while being captured by the stent 41. As the stent 41 is further pulled back, at least the fibrous components contained in the thrombus X are expelled from the body through the sheath 21 together with the stent 41. As a result, at least the fibrous components contained in the thrombus X are removed from the blood vessel V, as shown in Fig. 8.

[0053] The gel-like component contained in the thrombus X may or may not be collected into the sheath 21 together with the stent 41. This is because the gel-like component contained in the thrombus X may flow out of the stent 41 through the opening in the stent 41 on the thrombus X side or the mesh of the peripheral wall 411 during the process in which the thrombus X contracts in the radial direction and extends in the axial direction.

[0054] Therefore, in this embodiment, after the stent 41 is removed from the body, the aspirator 5 is used to aspirate the fluid from the blood vessel V. Specifically, as shown in FIG. 8 , the aspirator 5 aspirates the fluid from the blood vessel V through the sheath 21. If a gel-like component contained in the thrombus X remains in the blood vessel V, the aspirator 5 aspirates the gel-like component together with the blood. As a result, the gel-like component is also removed from the blood vessel V.

[0055] Although not shown in the figure, after suction by the aspirator 5 is completed, the fluid is discharged from the balloon 32, causing the balloon 32 to contract in the radial direction. Then, the balloon catheter 3 is removed to the outside of the body through the sheath 21. Furthermore, the sheath 21 is also removed to the outside of the body.

[0056] The thrombectomy procedure is then completed using known procedures.

[0057] [1-3.Effects] According to the first embodiment described above in detail, the following effects can be obtained.

[0058] (1a) In device 1, balloon 32 is configured to expand on the distal side within the blood vessel and press an object up to stent 41. Stent 41 is configured to expand radially when inserted into the blood vessel through sheath 21 and form a mesh-like peripheral wall 411. Furthermore, stent 41 is configured to contract radially and stretch axially while being able to be pulled back into sheath 21 in a state in which the object pressed by balloon 32 is captured inside from open end 41a.

[0059] With this configuration, when the stent 41 inserted into the blood vessel is pulled back into the sheath 21, the object captured by the stent 41 can be contracted in the radial direction and stretched in the axial direction in accordance with the change in shape of the stent 41. This allows the object to be retrieved into the sheath 21 together with the stent 41. Therefore, the object can be removed from the blood vessel.

[0060] (1b) In the device 1, the length L2 of the stent 41 in the radially expanded state is longer than the length of the target. With this configuration, the stent 41 inserted into the blood vessel can capture not only a part of the target, but the entire target, from the open end 41a. Therefore, even if the operation of removing the stent 41 from the body after capturing the target in the stent 41 is performed only once, the target can be removed from the blood vessel. As a result, the time required for the surgery to remove the target from the blood vessel can be shortened.

[0061] (1c) In the device 1, the balloon 32 is a Fogarty balloon. With this configuration, it is possible to reduce the load on the blood vessel when the balloon 32 is expanded.

[0062] (1d) The device 1 includes a suction device 5. The suction device 5 is configured to suction liquid from within a blood vessel through a sheath 21.

[0063] With this configuration, even if gel-like components contained in the target object remain in the blood vessel when the target object is removed from the blood vessel, the gel-like components can be aspirated by the aspirator 5. Therefore, it is possible to more easily remove gel-like components contained in the target object from the blood vessel.

[0064] [1-4. Correspondence] In the first embodiment, the sheath 21 corresponds to an example of a tubular portion, the balloon 32 corresponds to an example of an expansion portion, and the stent 41 corresponds to an example of a capturing portion.

[0065] [2. Second Embodiment] [2-1.Configuration] The second embodiment has the same basic configuration as the first embodiment, so differences will be described below. Note that the same reference numerals as those in the first embodiment indicate the same configuration, and reference is made to the preceding description.

[0066] The device 1A of the second embodiment differs from the device 1 of the first embodiment in that it includes a stent assembly 4A shown in Fig. 9 instead of the stent assembly 4 described above. The stent assembly 4A of the second embodiment includes a stent 43, a cover 44, and the shaft 42 described above.

[0067] 10A, the stent 43 of the second embodiment has substantially the same configuration as the stent 41 of the first embodiment. However, while the stent 41 of the first embodiment has both an open front end 41a and an open rear end 41b, the stent 43 of the second embodiment has only an open front end 43a. That is, the stent 43 of the second embodiment is cylindrical with a bottom. The stent 43 of the second embodiment has a cylindrical portion 431 and a bottom portion 432.

[0068] The cylindrical portion 431 is a cylindrical portion. The cylindrical portion 431 of this embodiment has a cylindrical shape.

[0069] The bottom 432 is a portion that closes one end in the axial direction of the cylindrical portion 431. The outer shape of the bottom 432 is a cone shape that becomes thinner with increasing distance from the cylindrical portion 431. In other words, the outer shape of a cross section perpendicular to the axial direction of the bottom 432 becomes smaller with increasing distance from the cylindrical portion 431. The outer shape of a cross section perpendicular to the axial direction of the bottom 432 is circular.

[0070] The peripheral wall of the tubular portion 431 constitutes at least a part of the peripheral wall 411 of the stent 43. In this embodiment, since the outer shape of the bottom portion 432 is conical, the peripheral wall of the tubular portion 431 and the peripheral wall of the bottom portion 432 each constitute a part of the peripheral wall 411 of the stent 43. The end of the tubular portion 431 opposite to the bottom portion 432 corresponds to the front end portion 43a of the stent 43. The end of the bottom portion 432 opposite to the tubular portion 431 corresponds to the rear end portion 43b of the stent 43. The shaft 42 extends from the rear end portion 43b of the stent 43 along the axial direction of the stent 43.

[0071] As shown in FIG. 10B, the cover 44 has a cover main body 441, a first communicating portion 442, a second communicating portion 443, and a string 444.

[0072] The cover body 441 is a portion configured to be able to house the stent 43 therein. The cover body 441 has flexibility. The cover body 441 is made of a biocompatible polymer.

[0073] The first communicating portion 442 and the second communicating portion 443 are provided in the cover main body 441. The first communicating portion 442 is a portion that forms a first opening N1 that communicates between the inside and outside of the cover main body 441. The second communicating portion 433 is a portion that forms a second opening N2 that communicates between the inside and outside of the cover main body 441. In the second communicating portion 433, an edge portion that forms the second opening N2 is folded back to form an insertion portion 4431 into which the string 444 can be inserted. The insertion portion 4431 is formed around the entire periphery so as to surround the second opening N2.

[0074] The string 444 is a linear portion. The string 444 is flexible. The string 444 is also biocompatible. The string 444 is made of, for example, metal. The string 444 is inserted into the insertion portion 4431. An intermediate portion of the string 444 is disposed inside the insertion portion 4431. The intermediate portion of the string 444 is a part of the string 444, and is a portion sandwiched between one end and the other end of the string 444 in the extension direction of the string 444. Both ends of the string 444 are disposed outside the cover main body 441.

[0075] The insertion portion 4431 is formed to surround the second opening N2, and the string 444 is inserted through the insertion portion 4431. As both ends of the string 444 are pulled, the second communication portion 433 contracts in the circumferential direction. When the second communication portion 433 contracts most in the circumferential direction, the second opening N2 is closed, as shown in Fig. 9. That is, the second communication portion 433 is configured to be changeable between a state in which the second opening N2 is open, as shown in Fig. 10B, and a state in which the second opening N2 is closed, as shown in Fig. 9.

[0076] As shown in FIG. 9 , in the stent assembly 4A, the stent 43 is housed inside the cover main body 441 with its front end 43a facing the first communicating portion 442 and its rear end 43b facing the second communicating portion 443. The shaft 42 extends to the outside of the cover main body 441 through the second opening N2. The first communicating portion 442 is attached to the stent 43. Specifically, the first communicating portion 442 is attached to the front end 43a of the stent 43. The cover 44 does not have any portion attached to the stent 43 except for the first communicating portion 442.

[0077] [2-2. Effect] The device 1A of the second embodiment is used to remove a thrombus X shown in FIG. 11A from inside a blood vessel V, similar to the device 1 of the first embodiment.

[0078] Specifically, first, the sheath 21 is inserted into the blood vessel V as described in detail in the first embodiment. The balloon catheter 3 is inserted into the blood vessel V through the sheath 21. Then, the balloon 32 is radially expanded on the distal side within the blood vessel V.

[0079] 11A, the stent assembly 4A is inserted into the sheath 21 in the same manner as the stent assembly 4 of the first embodiment. At this time, the stent 43 is covered with the cover body 441 and is in a state of being radially contracted by the compressive force of the sheath 21. As the stent assembly 4A is inserted into the blood vessel V through the sheath 21, the portion of the stent 43 exposed from the sheath 21 is released from the compressive force of the sheath 21 and expands radially. This portion then comes into contact with the inner wall of the blood vessel V over the entire circumference. This portion forms a mesh-like peripheral wall 411.

[0080] The stent assembly 4A is advanced within the blood vessel V until the front end 43a of the stent 43 reaches a position just before the thrombus X. In other words, the stent 43 is inserted proximally within the blood vessel V. When the stent 43 is inserted proximally within the blood vessel V, the front end 43a and rear end 43b of the stent 43 correspond to the end 43a of the stent 41 on the thrombus X side and the end 43b on the opposite side.

[0081] When inserted proximally within blood vessel V, the stent 43 is in a state where most of it is exposed from the sheath 21 and is expanded in the radial direction. However, the rear end 43b of the stent 43 is located within the sheath 21. The rear end 43b of the stent 43 is in a state where it is contracted in the radial direction because a compressive force from the sheath 21 continues to be applied to the rear end 43b of the stent 43. In addition, the second communication portion 443 of the cover 44 is located further rearward than the rear end 43b of the stent 43.

[0082] Next, the balloon catheter 3 is pulled back as described in detail in the first embodiment. As a result, as shown in Fig. 11B, the balloon 32 in a radially expanded state presses the thrombus X up to the stent 43. The thrombus X is then introduced into the stent 43 from the front end 43a. That is, the stent 43 covered with the cover 44 captures the thrombus X therein.

[0083] Next, the string 444 is loosened, thereby opening the second opening N2. Then, the shaft 42 is pulled back while maintaining the position of the string 444. As a result, the stent 43 is pulled back into the sheath 21, as shown in FIG. 12. A compressive force from the sheath 21 is applied to the stent 43 in the radial direction from the portion of the stent 43 that has been pulled back into the sheath 21, causing the stent 43 to contract in the radial direction and expand in the axial direction. At this time, because the second opening N2 is in the open state, the stent 43 is pulled back into the sheath 21 while being pulled out to the outside of the cover body 441 through the second opening N2.

[0084] Here, the first communicating portion 442 is attached to the stent 43. Therefore, as shown in FIG. 13 , when the stent 43 is pulled out of the cover main body 441 through the second opening N2, the first communicating portion 442 is pulled by the stent 43. This causes the cover main body 441 to deform so that the first communicating portion 442 enters the inside of the cover main body 441. Then, the cover main body 441 forms a collection space S between the inwardly bent portion and the outwardly positioned portion. Until the stent 43 is completely pulled out of the cover main body 441 through the second opening N2, the collection space S communicates with the interior of the stent 43 via the mesh of the peripheral wall 411 of the stent 43.

[0085] 12, as the stent 43 contracts in the radial direction and expands in the axial direction, the thrombus X captured by the stent 43 also contracts in the radial direction and expands in the axial direction. Then, as shown in Fig. 14A, at least the fibrous component contained in the thrombus X is collected into the sheath 21 together with the stent 43 while being captured by the stent 43.

[0086] On the other hand, as described in detail in the first embodiment, the gel-like component contained in the thrombus X may flow out of the stent 43 as the thrombus X contracts in the radial direction and expands in the axial direction. Therefore, the gel-like component contained in the thrombus X may not be collected together with the stent 43 into the sheath 21. However, in the present embodiment, as the stent 43 is pulled back into the sheath 21, the cover main body 441 deforms as described above, forming the collection space S. Therefore, when the gel-like component contained in the thrombus X flows out of the stent 43 through the mesh of the peripheral wall 411 of the stent 43, the gel-like component is collected in the collection space S.

[0087] 14A and 14B, the stent 43 is further pulled back into the sheath 21. Then, the stent 43 is completely pulled out from the second opening N2 to the outside of the cover main body 441. As a result, the first communicating portion 442 is positioned further rearward than the second communicating portion 443.

[0088] Next, as shown in Fig. 14B, the string 444 is pulled, thereby closing the second opening N2. As a result, the collection space S becomes a closed space, as shown in Fig. 15. In other words, the gel-like components collected in the collection space S do not flow out of the collection space S.

[0089] 14B and is removed from the body. The cover 44 attached to the stent 43 is also removed from the body along with the stent 43. As a result, at least the fibrous components contained in the thrombus X are removed from the blood vessel V. If the cover 44 has captured gelatinous components contained in the thrombus X in the collection space S, the gelatinous components are also removed from the blood vessel V.

[0090] Next, as described in detail in the first embodiment, the fluid is aspirated from the blood vessel V using the aspirator 5. As a result, even if gel-like components contained in the thrombus X remain in the blood vessel V, the gel-like components are removed from the blood vessel V.

[0091] Thereafter, the thrombectomy operation is completed in the same manner as in the first embodiment.

[0092] [2-3. Effects] According to the second embodiment described above in detail, the same effects as those of the first embodiment can be obtained, and further, the following effects can be obtained.

[0093] The device 1A has a cover body 441. The cover body 441 is provided with a first communication portion 442 and a second communication portion 443. The first communication portion 442 is attached to the stent 43. The second communication portion 443 is configured so that the second opening N2 can be switched between an open state and a closed state.

[0094] With this configuration, by pulling back the stent 43 inserted into the blood vessel into the sheath 21, the collection space S can be formed by the cover body 441. Therefore, even if gel-like components contained in the target captured by the stent 43 pass through the mesh of the peripheral wall 411 of the stent 43 and flow out of the stent 43, the gel-like components can be collected in the collection space S. This makes it even easier to remove the gel-like components contained in the target from the blood vessel.

[0095] [2-4. Correspondence] In the second embodiment, the sheath 21 corresponds to an example of a tubular portion. The balloon 32 corresponds to an example of an expansion portion. The stent 43 corresponds to an example of a capturing portion. The cover body 441 corresponds to an example of a covering portion.

[0096] 3. Other Embodiments Although the embodiments of the present disclosure have been described above, it goes without saying that the present disclosure is not limited to the above-described embodiments and can take on various forms.

[0097] (3a) In the first embodiment, the stent 41 has openings at both front and rear ends 41a, 41b. When the stent 41 is inserted into a blood vessel, the position of the stent 41 is adjusted so that the rear end 41b of the stent 41 remains inside the sheath 21. In this case, the stent 41 can be more easily pulled back into the sheath 21.

[0098] However, when the stent 41 is inserted into the blood vessel, the rear end 41b of the stent 41 does not necessarily have to remain inside the sheath 21. For example, as shown in FIG. 16A, the stent 41 may be advanced into the blood vessel V until both the front and rear ends 41a, 41b are exposed from the sheath 21. In this case, as shown in FIG. 16B, the stent 41 can further prevent the blood flow caused by pulling back the balloon catheter 3 from being obstructed by the stent 41. Therefore, the thrombus X can be inserted into the stent 41 with even less force. In other words, the thrombus X can be captured by the stent 41 with even less force. As a result, the burden on the surgeon can be reduced.

[0099] (3b) In the second embodiment, the rear end 43b of the stent 43 is closed. The stent 43 is housed inside the cover body 441.

[0100] However, when the device includes a stent and a cover body as in the second embodiment, the rear end of the stent does not necessarily have to be closed. The stent may have both the front and rear ends open, for example, as in the stent 41 of the first embodiment.

[0101] (3c) For example, if the device does not have a cover body, the stent may be open at both the front and rear ends, as in the stent 41 of the first embodiment described above, or only the front end may be open, as in the stent 43 of the second embodiment described above.

[0102] (3d) In the above embodiments, the length L2 of the stents 41, 43 in the radially expanded state is longer than the length of the target. However, the length L2 of the stent in the radially expanded state does not necessarily have to be longer than the length of the target. For example, if the length L2 of the stent in the radially expanded state is shorter than the length of the target, the target can be removed from the blood vessel by capturing the target with the stent and then removing the stent from the body, repeating this operation multiple times.

[0103] (3e) In the second embodiment, the first communicating portion 442 is attached to the front end portion 43a of the stent 43. However, the first communicating portion may be attached to any part of the stent. However, it is preferable that the first communicating portion be attached to a part of the stent that is further forward, since this allows a larger collection space S to be formed.

[0104] (3f) In the above embodiment, the balloon catheter 3 is of a rapid exchange type. However, the balloon catheter may be, for example, of an over-the-wire type.

[0105] (3g) In the above embodiment, the device 1, 1A includes the aspirator 5. However, the device does not necessarily have to include the aspirator.

[0106] (3h) The function of one component in the above embodiments may be distributed among multiple components, or the functions of multiple components may be integrated into one component. Also, part of the configuration of the above embodiments may be omitted. Furthermore, at least part of the configuration of the above embodiments may be added to or substituted for the configuration of another of the above embodiments.

[0107] [Technical idea disclosed in this specification] [Item 1] A device for removing an object including at least one of a thrombus and a foreign body from a blood vessel, a tubular portion to be inserted into the blood vessel; an expansion portion configured to expand radially at a distal side of the tubular portion that is farther from the target within the blood vessel than the target; a cylindrical capturing part that is inserted through the tubular part to a proximal side closer to the tubular part than the object in the blood vessel, the capturing part having an open end at least on the object side; Equipped with the expansion portion is configured to expand on the distal side in the blood vessel and press the object toward the capturing portion; The capture unit is When inserted into the blood vessel through the tubular portion, the catheter is configured to radially expand and form a mesh-like peripheral wall, The device is configured to be able to capture the object pressed by the expansion portion through the open end and then pull it back into the tubular portion while contracting radially and expanding axially.

[0108] [Item 2] Item 1, the device according to Further, a covering portion configured to be able to accommodate the capture portion therein is provided, The covering portion has a first communication portion that forms a first opening that communicates the inside and outside of the covering portion; a second communication portion that forms a second opening that communicates the inside and outside of the covering portion; is established, the first communication portion is attached to the capture portion, The device, wherein the second communication portion is configured so that the second opening can be switched between an open state and a closed state.

[0109] [Item 3] The device according to item 1 or 2, A device in which the capture portion is open at both ends, on the object side and the opposite side.

[0110] [Item 4] The device according to any one of items 1 to 3, A device wherein the length of the capture portion in its expanded state is longer than the length of the object.

[0111] [Item 5] The device according to any one of items 1 to 4, The device, wherein the expansion portion is a Fogarty balloon.

[0112] [Item 6] The device according to any one of items 1 to 5, The device further comprises an aspirator configured to aspirate fluid from within the blood vessel through the tubular portion. [Explanation of symbols]

[0113] 1,1A...device, 2...sheath assembly, 21...sheath, 22...hub, 23...tube, 24...three-way stopcock, 3...balloon catheter, 31...catheter, 32...balloon, 33...guidewire, 4,4A...stent assembly, 41,43...stent, 42...shaft, 44...cover, 441...cover body, 442...first communication portion, 443...second communication portion, 5...suction device, N1...first opening, N2...second opening, S...collection space, V...blood vessel, X...thrombus.

Claims

1. A device for removing an object including at least one of a thrombus and a foreign body from a blood vessel, a tubular portion to be inserted into the blood vessel; an expansion portion configured to expand radially at a distal side of the tubular portion that is farther from the target within the blood vessel than the target; a cylindrical capturing part that is inserted through the tubular part to a proximal side closer to the tubular part than the object in the blood vessel, the capturing part having an open end at least on the object side; Equipped with the expansion portion is configured to expand on the distal side in the blood vessel and press the object toward the capturing portion; The capture unit is When inserted into the blood vessel through the tubular portion, the catheter is configured to radially expand and form a mesh-like peripheral wall, The device is configured to be able to capture the object pressed by the expansion portion through the open end and then pull it back into the tubular portion while contracting radially and expanding axially.

2. 10. The device of claim 1, Further, a covering portion configured to be able to accommodate the capture portion therein is provided, The covering portion has a first communication portion that forms a first opening that communicates the inside and outside of the covering portion; a second communication portion that forms a second opening that communicates the inside and outside of the covering portion; is established, the first communication portion is attached to the capture portion, The device, wherein the second communication portion is configured so that the second opening can be switched between an open state and a closed state.

3. 3. A device according to claim 1 or claim 2, A device in which the capture portion is open at both ends, on the object side and the opposite side.

4. 3. A device according to claim 1 or claim 2, A device wherein the length of the capture portion in its expanded state is longer than the length of the object.

5. 3. A device according to claim 1 or claim 2, The device, wherein the expansion portion is a Fogarty balloon.

6. 3. A device according to claim 1 or claim 2, The device further comprises an aspirator configured to aspirate fluid from within the blood vessel through the tubular portion.

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