WO2019163914A1

WO2019163914A1 - Foreign material removal device

Info

Publication number: WO2019163914A1
Application number: PCT/JP2019/006616
Authority: WO
Inventors: 周平松下
Original assignee: テルモ株式会社
Priority date: 2018-02-26
Filing date: 2019-02-21
Publication date: 2019-08-29
Also published as: JP2021065246A

Abstract

Provided is a foreign material removal device with which it is possible to remove and pulverize a foreign material in a minimally invasive manner, even if the foreign material is a hard foreign material, and to perform a treatment efficiently. The foreign material removal device comprises a tip portion (130) capable of being rotated about an axial direction (D1). A communicating hole (132) is formed in the tip portion (130). The communicating hole (132) is bent from the tip side in the axial direction (D1) in a lateral direction intersecting the axial direction (D1), and communicates with the outside on the tip side and in the lateral direction.

Description

Foreign object removal device

The present invention relates to a foreign matter removing device.

Conventionally, various devices for removing hard foreign bodies such as wall thrombus and organic hard thrombus from a biological lumen such as a blood vessel have been proposed. For example, the device described in Patent Document 1 is placed in a biological lumen. By directly applying a rotating blade to the generated hard foreign matter, the foreign matter is removed and finely pulverized so as to be discharged from the living body lumen.

JP 2009-000315 A

However, according to the device that directly cuts the blade against the foreign material as in the above-described prior art, the blade is likely to directly contact not only the foreign material but also a normal part in the vicinity thereof, so that the blood vessel wall may be damaged. Yes and highly invasive.

In addition, according to the device as in the above prior art, the foreign matter can be removed only at the tip portion where the blade is provided, and the removal range is narrow. Take it.

Therefore, an object of the present invention is to provide a foreign matter removing device that can remove and pulverize foreign matter in a minimally invasive manner even if it is a hard foreign matter, and can efficiently proceed with the treatment.

In order to achieve the above object, the foreign matter removing device of the present invention has a tip portion that can rotate around the axial direction, and a communication hole is formed inside the tip portion. The communication hole is bent in the lateral direction intersecting the axial direction from the distal end side in the axial direction, and communicates with the outside in the distal end side and the lateral direction.

According to the foreign matter removing device having the above configuration, a swirling flow is generated with the rotation of the tip portion, and hard foreign matter is removed by the action of the swirling flow. Therefore, the blood vessel wall may be damaged by the blade like cutting. Even if it is a hard foreign substance, a foreign substance can be removed minimally invasively.

In addition, the foreign matter is not only crushed by the swirling flow, but also attracted to the tip by the circulation of the swirling flow, and further crushed by the rotating tip, so that the foreign matter can be reliably fined and discharged to the outside of the body. Is easy.

Since the swirl flow is generated not only around the tip but also in front of it, the removal range of the foreign matter is wide, and the treatment can be advanced efficiently.

It is a perspective view of the foreign substance removal device of a 1st embodiment. It is a perspective view which makes the front end side of the foreign material removal device of 1st Embodiment into a partial cross section. FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. It is the side view seen from the code | symbol 4 of FIG. It is the front view seen from the code | symbol 5 of FIG. It is a figure which shows insertion of the foreign material removal device to the blood vessel. It is a figure which shows rotation of the front-end | tip part of the foreign material removal device inserted in the blood vessel. It is a figure which shows the removal of the foreign material by a foreign material removal device. It is the front view which looked at the front-end | tip part of 2nd Embodiment toward the opposite base end side from the front end side. FIG. 10 is a cross-sectional view taken along line 10-10 in FIG. It is a figure which shows the example which used the foreign material removal device and the protection device together.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and is different from an actual ratio.

<First Embodiment>
As shown in FIG. 1, the foreign substance removal device 100 according to the first embodiment includes a hand operation unit 110, an insertion unit 120, and a tip part 130. In the foreign matter removing device 100, the guide wire W can be inserted through the insertion hole 111 formed on the proximal end side of the hand operation unit 110 and the insertion hole 131 formed on the distal end side of the distal end portion 130.

The hand operation unit 110 is used to operate the foreign matter removal device 100 by the user. The insertion unit 120 is connected to the distal end side of the hand operation unit 110.

The insertion portion 120 is long and flexible, and can be inserted into a blood vessel (biological lumen). The diameter of the insertion portion 120 is not particularly limited, but is, for example, 3 mm to 5 mm. On the distal end side of the insertion portion 120, a suction port 121 is formed in the vicinity of the distal end portion 130, and a balloon 122 (expansion / contraction body) is provided.

The suction port 121 communicates with a suction port 112 provided in the hand operation unit 110. The suction port 112 can be connected to, for example, a syringe (not shown). By pulling the pusher of the syringe connected to the suction port 112, suction at the suction port 121 occurs.

The balloon 122 communicates with the supply / discharge port 113 provided in the hand operation unit 110. The supply / discharge port 113 can be connected to, for example, a syringe (not shown). The balloon 122 is shown in a contracted state in FIG. 1, but for example, when a pusher of a syringe connected to the supply / discharge port 113 is pressed and a working fluid such as physiological saline is supplied, It expands so that a diameter may be enlarged in the direction orthogonal to the direction D1. Further, the expanded balloon 122 is contracted by, for example, pulling a pusher of a syringe connected to the supply / discharge port 113 and discharging a working fluid such as physiological saline from the balloon 122.

The distal end portion 130 is provided at the distal end of the insertion portion 120. The suction port 121 and the balloon 122 are located on the proximal side with respect to the distal end portion 130 in the axial direction D1. The distal end portion 130 can be rotated around the axial direction D <b> 1 by the driving force from the hand operation unit 110. For example, when the connector 114 provided in the hand operation unit 110 is connected to the pump and, for example, compressed gas is supplied from the pump, the rotating blades in the hand operation unit 110 thereby rotate, and the tip is linked to this. The part 130 rotates. For example, the distal end portion 130 may be rotated by a driving force from a motor provided in the hand operation unit 110.

As illustrated in FIG. 2, the insertion unit 120 includes a sheath 123 and a drive shaft 124 disposed therein, and the driving force from the hand operation unit 110 is transmitted through the drive shaft 124 to the distal end portion 130. To be told.

The drive shaft 124 and the tip portion 130 are integrated, and the tip portion 130 rotates as the drive shaft 124 is rotated by the driving force from the hand operation unit 110. The drive shaft 124 is hollow, and the lumen 125 inside thereof is in communication with the insertion hole 131. The guide wire W is inserted through the lumen 125 and the insertion hole 131.

The sheath 123 has a long cylindrical shape and is flexible. A suction port 121 is formed on the outer periphery on the distal end side of the sheath 123. The suction port 121 communicates with the suction port 112 of the hand operation unit 110 through the lumen of the sheath 123.

Further, as shown in FIG. 3, in the sheath 123, a lumen 127 is formed in the thick portion 126. The lumen 127 communicates with the balloon 122 and extends to the proximal end side to communicate with the supply / discharge port 113 of the hand operation unit 110. The balloon 122 expands and contracts by the inflow / discharge of the working fluid through the lumen 127.

As shown in FIG. 4, a communication hole 132 is formed inside the tip portion 130. The communication hole 132 is bent in the lateral direction intersecting the axial direction D1 from the distal end side in the axial direction D1, and communicates with the outside of the distal end portion 130 in the distal end side and the lateral direction. The distal end side of the distal end portion 130 has a spherical shape, but the shape of the distal end portion 130 is not limited to this, and may be a cylindrical shape.

As shown in FIG. 5, the communication holes 132 are formed at equal intervals in the rotation direction D2 of the distal end portion 130. In the present embodiment, three communication holes 132 are formed at equal intervals in the rotation direction D2, but the number is not particularly limited.

Next, a procedure using the foreign matter removing device 100 will be described.

As shown in FIG. 6, in the treatment using the foreign substance removal device 100, the insertion part 120 is inserted into the blood vessel along the preceding guide wire W, and the blood vessel is blocked or narrowed by the hard foreign substance S. Delivered to. The hard foreign substance S is, for example, a plaque or a thrombus.

When an operator such as a doctor confirms that the distal end portion 130 has reached the vicinity of the foreign substance S under fluoroscopy, for example, the insertion portion 120 is stopped and the balloon 122 is expanded. Expansion of the balloon 122 closes the base end side of the foreign matter S. After the balloon 122 is expanded, the surgeon starts to rotate the distal end portion 130.

As shown in FIG. 7, when the tip portion 130 rotates, the blood filled in the communication hole 132 is discharged from the lateral opening of the communication hole 132 by the centrifugal force. Moreover, the opening part of the front end side of the communicating hole 132 will be in a negative pressure state by that, and a suction force will arise on the front end side. And the blood which came out of the opening part of the side direction of the communicating hole 132 flows to the front end side with the suction force.

As a result, as shown in FIG. 8, a swirling flow F that circulates from the side of the tip portion 130 to the front and further from the front to the tip portion 130 is generated, whereby the foreign matter S is removed from the blood vessel wall V. The swirling flow F is generated over the entire inner circumference of the blood vessel wall V as the distal end portion 130 rotates, so that the foreign matter S is removed at a time along the entire inner circumference of the blood vessel wall V.

The foreign matter S is pulverized by the action of the swirl flow F, drawn to the tip portion 130 by the circulation of the swirl flow F, and further crushed by hitting the rotating tip portion 130. The finely crushed foreign matter S is sucked into the suction port 121 and discharged outside the body. The suction at the suction port 121 may be generated simultaneously with the rotation of the distal end portion 130 or may be generated thereafter.

Next, the function and effect of this embodiment will be described.

Since the foreign substance removal device 100 of this embodiment removes the hard foreign substance S from the blood vessel wall V by the swirl flow F, the blood vessel wall V is hardly damaged by the blade as in cutting, and the hard foreign substance S can be removed in a minimally invasive manner. .

Further, since the swirl flow F is generated using blood in the blood vessel (body fluid in the living body lumen), for example, it is not necessary to press a fluid such as physiological saline into the body to generate the swirl flow F. , Can reduce the burden on the patient.

If the removed foreign matter S is large, it is difficult to discharge it to the outside of the body. However, according to the present embodiment, the foreign matter S is not only crushed by the swirl flow F but also drawn to the tip 130 by circulation of the swirl flow F. Then, it is further crushed by the rotating tip 130. For this reason, the foreign material S can be reliably made fine and can be easily discharged outside the body.

The swirl flow F is generated not only around the tip 130 but also in front of it. For this reason, the removal range of the foreign substance S is wide, and the treatment can be advanced efficiently.

The distal end side of the distal end portion 130 has a spherical shape, and the distal end portion 130 is excellent in safety because it is difficult to damage the vascular wall V even if the distal end side hits the vascular wall V.

In the tip portion 130, the communication holes 132 are formed at equal intervals in the rotation direction D2, and the swirling flow F is uniformly generated around the tip portion 130. For this reason, the front-end | tip part 130 rotates stably and it is easy to remove the foreign material S without deviation in the whole inner periphery of the blood vessel wall V. FIG.

Further, the suction port 121 is formed in the vicinity of the tip portion 130, and the removed foreign matter S is easily sucked. For this reason, it is difficult for the foreign substance S removed in the blood vessel to remain, and it is possible to effectively prevent stenosis, occlusion, and the like due to the remaining foreign substance S.

Further, the diffusion of the removed foreign matter S is blocked by the balloon 122. For this reason, it is difficult for the removed foreign matter S to move to other locations, and it is possible to effectively prevent stenosis, blockage, etc. from occurring at other locations.

Second Embodiment
As shown in FIG. 9, the second embodiment is different from the first embodiment in that a blade 133 is provided in the opening 135 on the distal end side of the communication hole 132. About another structure, since this embodiment is the same as that of 1st Embodiment, the same code | symbol is used and the overlapping description here is abbreviate | omitted.

The blade 133 may be provided as a separate member at the edge of the opening 135 or may be formed by processing the edge of the opening 135 itself. The opening 135 rotates with the rotation of the tip 130, and the cutting edge 134 of the blade 133 protrudes toward the rotation direction d2 of the opening 135 in the front view shown in FIG.

Further, as shown in FIG. 10, the cutting edge 134 is on the side of the communication hole 132 including the opening 135 in the cross section along the axial direction D1. That is, the cutting edge 134 does not protrude further toward the tip than the opening 135 in the axial direction D1.

In the present embodiment, since the blade 133 is provided in the opening 135 and the crushing ability with respect to the foreign matter S is high, the foreign matter S can be crushed more finely. In particular, the blade edge 134 protrudes in the rotation direction d2 side, and the blade edge 134 is likely to hit the foreign object S when the tip portion 130 rotates. For this reason, the foreign material S can be pulverized particularly effectively.

Moreover, since the cutting edge 134 does not protrude to the tip side from the opening 135 in the cross section along the axial direction D1, it is difficult to damage the blood vessel wall V and is excellent in safety.

The present invention is not limited to the embodiment described above, and various modifications can be made within the scope of the claims.

For example, the target for which the foreign substance removing device of the present invention is used is not limited to a blood vessel, and may be used in a biological lumen other than the blood vessel.

Moreover, the form without the suction port 121 and the balloon 122 of the above embodiment is also included in the scope of the present invention. When there is no suction port, for example, after removing the foreign matter, the foreign matter removing device may be removed from the biological lumen, and the suction device may be inserted into the biological lumen instead. In the said embodiment, since the suction opening 121 is provided in the foreign material removal device 100, such a effort can be saved and a treatment can be advanced smoothly.

Moreover, as shown in FIG. 11, the bag-like protection device 1000 that can be expanded and contracted may be used together to more effectively prevent the removed foreign matter S from diffusing.

This application is based on Japanese Patent Application No. 2018-032064 filed on Feb. 26, 2018, the disclosure content of which is incorporated by reference as a whole.

100 foreign matter removal device,
110 Hand control unit,
120 insertion part,
121 suction port,
122 balloon (expanded body),
123 sheath,
124 drive shaft,
130 tip,
131 insertion hole,
132 communication holes,
133 blades,
134 cutting edge,
135 Opening on the tip side of the communication hole,
D1 axial direction,
D2 direction of rotation of the tip,
d2 direction of rotation of the opening that rotates with the tip,
F swirl flow,
S hard foreign matter,
V blood vessel wall,
W Guide wire.

Claims

It has a tip that can rotate around the axial direction,
A foreign matter removing device that is bent in a lateral direction intersecting the axial direction from the distal end side in the axial direction inside the distal end portion, and has a communication hole communicating with the outside in the distal end side and the lateral direction. .
Having a blade at the opening on the tip side in the communication hole;
The blade has a cutting edge that protrudes in a rotation direction side of the opening that rotates together with the distal end portion in a front view when the distal end portion is viewed from the distal end side toward the opposite proximal end side. The foreign matter removing device described in 1.
The foreign material removing device according to claim 2, wherein the cutting edge is on the communication hole side including the opening in a cross section along the axial direction.
The foreign matter removing device according to any one of claims 1 to 3, wherein the tip side of the tip portion has a spherical shape.
The foreign matter removing device according to any one of claims 1 to 4, wherein the communication holes are formed at equal intervals in a rotation direction of the tip portion.
The foreign matter removal according to any one of claims 1 to 5, wherein a suction port is formed closer to the distal end than the distal end opposite to the distal end and in proximity to the distal end. device.
The foreign matter removing device according to any one of claims 1 to 6, further comprising an expandable / contractible body that is expandable and contractible on a proximal end side with respect to the distal end portion opposite to the distal end side.