JP2021037282A - catheter - Google Patents

Abstract

To provide means capable of readily recognize a rotation posture about an axis line of a catheter in a radiographic video picture.SOLUTION: A catheter 10 includes: a shaft 11 having a cylindrical blade tube 31 through which a radiation ray is transmitted; and markers 61, 62 positioned in the blade tube 31 and having a radiation transmissivity which is different from the blade tube 31. Respective markers 61, 62 are positioned while not overlapping on each other in an axial direction 101 and a circumferential direction 102.SELECTED DRAWING: Figure 3

Description

The present invention relates to a catheter inserted into the lumen of a human or animal.

For example, catheters that are inserted into the coronary arteries to remove porridge formed in the human coronary arteries are known. Such a procedure is also referred to as directional coronary atherectomy (DCA). There is an opening in the distal part of the catheter, and the porridge that has entered the internal space of the catheter through the opening is excised by a cutter that moves in the axial direction while rotating in the internal space of the catheter. In DCA, the position of the opening of the catheter inserted into the coronary artery (posture of the catheter) and the position of the porridge are grasped by images taken using radiation such as X-rays.

It is not limited to DCA that the posture of the catheter needs to be grasped. For example, in the case of a catheter in which the cannula protrudes from the side surface, it is necessary to grasp the posture of the catheter in order to specify the direction in which the cannula exits.

Patent Document 1 discloses a catheter system including an LT-oriented marker. The posture of the catheter is grasped depending on whether the shape of the LT-oriented marker in the radiographed image is an L-shape or a T-shape.

Japanese Unexamined Patent Publication No. 2012-192209

However, there are two postures in which the LT-oriented marker looks like a T-shape in the radiographed image: the posture in which the LT-oriented marker is located on the outer surface on the front side of the catheter and the posture in which the LT-oriented marker is located on the outer surface on the other side. There may be postures, but it is difficult to distinguish between these two postures in the video. Therefore, the practitioner who operates the catheter may not be able to immediately determine which of the two postures the catheter is in, even if the LT-oriented marker looks like a T-shape.

In addition, in a posture in which the LT-oriented marker looks like an L-shape in a radiographed image, what proportion of a part of the marker extending along the axial direction in the L-shape is located on the outer surface on the front side of the catheter. It is also difficult to determine if it is in a state. Therefore, even if the LT-oriented marker looks like an L-shape, the practitioner can only recognize the posture of the catheter within a range of a predetermined circumferential angle with a certain degree of accuracy.

The present invention has been made in view of the above-mentioned circumstances, and an object of the present invention is to provide a means for easily recognizing a rotational posture around the axis of a catheter in a radiographically photographed image.

(1) The catheter according to the present invention includes a shaft having a cylindrical transmitting portion through which radiation is transmitted, and at least two markers located in the transmitting portion and having different radiation permeability from the transmitting portion. It has. The markers are located at positions that do not overlap each other in the axial direction and the circumferential direction of the transmission portion.

The rotational posture around the axis of the catheter can be easily recognized depending on the positional relationship of each marker, for example, whether or not the edges of the markers are in a straight line.

(2) The two markers adjacent to each other in the circumferential direction differ in the circumferential angle of the transmissive portion with respect to the axis by 90 degrees.

The rotational posture around the axis of the catheter can be easily recognized by the degree of overlap or separation of two markers adjacent to each other in the circumferential direction.

(3) For example, each of the above markers has the same length along the circumferential direction.

(4) The two markers adjacent to each other in the axial direction partially overlap in the axial direction.

When the rotational posture around the axis of the catheter becomes a predetermined circumferential angle, two markers adjacent to each other in the axial direction appear to be one continuous marker. This makes it possible to recognize that the rotational posture around the axis of the catheter has become a predetermined circumferential angle.

(5) The two markers adjacent to each other in the axial direction have different lengths along the axial direction.

Each marker can be easily identified by the difference in length in the axial direction.

(6) The catheter according to the present invention includes a ring body extending in an annular shape along the circumferential direction. Each of the above markers is directly linked to the ring through the other markers or not directly through the other markers.

Since the plurality of markers are integrally formed through the ring body, it is possible to reduce the misalignment between the markers that may occur during manufacturing. Since the ring body is formed over the entire circumference of the transmission portion, it is possible to prevent the ring body and each marker from coming off from the transmission portion.

(7) For example, the catheter according to the present invention is located at a different position in the axial direction from the transmissive portion, and has a cylindrical portion having different radiation permeability from the transmissive portion and a part of the peripheral wall of the cylindrical portion. The opening formed in the cylinder, the cutter that can move along the axis direction while rotating around the axis of the shaft in the internal space of the cylinder, and the position opposite to the opening with respect to the axis of the cylinder. A balloon that inflates outward in the radial direction of the shaft is further provided.

(8) One of the plurality of markers is at the same position as the opening in the circumferential direction.

Since any one of the plurality of markers is in the same position as the opening in the circumferential direction, the position of the opening can be easily recognized.

(9) The catheter according to the present invention is located in the internal space of the shaft, and further includes a support through which a guide wire passing through the internal space is inserted. The support is different in radiation permeability from the transmitting portion.

The support can be used as a marker.

According to the catheter according to the present invention, the rotational posture around the axis of the catheter can be easily recognized in the radiographed image.

FIG. 1 is a side view showing an external configuration of the catheter 10 in a state where the balloon 23 is contracted. FIG. 2 is an enlarged cross-sectional view showing an internal configuration in the vicinity of the tip portion 13 of the catheter 10. FIG. 3 is an enlarged side view showing the appearance configuration of the vicinity of the tip portion 13 of the catheter 10. 4A and 4B are cross-sectional views showing an IV-IV cross section of FIG. 3, where FIG. 4A shows a configuration without a support 70, and FIG. 4B shows a configuration with a support 70. FIG. 5 is a schematic view showing a state in which the balloon 23 is expanded in the blood vessel 50. FIG. 6 is a schematic view showing a state after the porridge tumor 51 is resected in the blood vessel 50. FIG. 7 is a side view schematically showing images around the markers 61 and 62 taken by X-ray. FIG. 8 is a cross-sectional view showing the IV-IV cross section of FIG. 3, showing a state in which the markers 61 and 62 have moved in the circumferential direction 102 from the state shown in FIG. 4 (A). FIG. 9 is an enlarged side view showing the periphery of the marker 60 of the catheter 10 in the modified example. FIG. 10 is an enlarged side view showing the appearance configuration of the vicinity of the tip portion 13 of the catheter 10 in the modified example. FIG. 11 is an enlarged cross-sectional view showing an internal configuration in the vicinity of the tip portion 13 of the catheter 10 in the modified example. FIG. 12 is a side view schematically showing images around the markers 61 and 62 and the support portion 70 taken by X-ray. FIG. 13 is an enlarged side view showing the periphery of the marker 60 of the catheter 10 in the modified example. FIG. 14 is an enlarged side view showing the periphery of the marker 60 of the catheter 10 in the modified example. FIG. 15 is an enlarged side view showing the periphery of the marker 60 of the catheter 10 in the modified example. FIG. 16 is a schematic view showing a method of fixing the markers 61 and 62 to the end portion 37. FIG. 17 is a schematic view showing a method of fixing the markers 61 and 62 to the end portion 37.

Hereinafter, preferred embodiments of the present invention will be described. Needless to say, the present embodiment is only one embodiment of the present invention, and the embodiments can be changed without changing the gist of the present invention.

The catheter 10 shown in FIG. 1 is for excision of porridge, and is connected to a shaft 11, a cutter 12 provided in the shaft 11, and a proximal end of the shaft 11 as shown in FIGS. 1 and 2. A base end portion 14 and a drive portion 15 that imparts a rotational drive to the cutter 12 are provided.

The shaft 11 is a tube that can contain the cutter 12 inside. The shaft 11 is roughly divided into a main body portion 16, an intermediate portion 17, and a tip portion 13. The main body portion 16, the intermediate portion 17, and the tip portion 13 are located at different positions in the axial direction 101 of the shaft 11. The intermediate portion 17 corresponds to a cylindrical portion.

The main body 16 is, for example, a circular tube made of synthetic resin, and is elastically curved according to the curved shape of the blood vessel.

As shown in FIG. 2, the intermediate portion 17 is connected to the tip of the main body portion 16 and its internal space communicates with the internal space of the main body portion 16. The intermediate portion 17 is made of a material having a smaller radiation permeability such as X-rays than the end portion 37 of the blade tube 31, which will be described later. In the present embodiment, the intermediate portion 17 is, for example, a medical stainless steel circular tube. The intermediate portion 17 is fitted into the tip of the main body portion 16 from the outside.

The tip portion l3 is composed of a circular tube. The tip portion 13 is connected to the tip of the intermediate portion 17, and its internal space communicates with the internal space of the intermediate portion 17. The base end of the intermediate portion 17 is connected to the main body portion 16, and the tip of the intermediate portion 17 is connected to the tip portion 13. The tip portion 13 will be described in detail later.

The tip of the shaft 11 (the tip of the tip 13) and the base end of the shaft 11 (the base end of the main body 16) are open. The outer diameter of the shaft 11 is set according to the inner diameter of the blood vessel to be inserted, for example, the coronary artery. The inner diameter of the shaft 11 is set according to the outer diameter of the cutter 12. The outer diameter and inner diameter of the shaft 11 are substantially uniform over the axial direction 101 of the shaft 11. The length of the shaft 11 in the axial direction 101 is set in consideration of the length from the catheter insertion portion to the affected portion of a human limb or the like.

As shown in FIGS. 2 and 3, an opening 20 is formed in a part of the peripheral wall 25 of the intermediate portion 17. The opening 20 is formed by notching a part of the peripheral wall 25. The shape and size of the opening 20 are set in consideration of the shape and size of the porridge 51 (see FIG. 5) that may be formed in the affected area.

A cutter 12 is provided in the vicinity of the opening 20 in the internal space of the shaft 11 (specifically, the space extending from the internal space of the intermediate portion 17 to the portion of the internal space of the main body 16 located near the intermediate portion 17). It is provided. The cutter 12 has a blade portion 21 and a shaft 22. The blade portion 21 has a substantially cylindrical shape, and its outer diameter is slightly smaller than the inner diameter of the shaft 11. A plurality of blades are formed on the tip end side of the blade portion 21 so as to extend radially from the center. Although not shown in the figure, a through hole is formed in the center of the blade portion 21 along the axial direction 101. The shaft 22 extends from the base end of the blade portion 21 to the outside of the base end portion 14. The shaft 22 is an elongated tube, and the internal space thereof communicates with the through hole of the blade portion 21. The internal space of the shaft 22 and the through hole of the blade portion 21 are for inserting the guide wire.

As shown in FIG. 1, the shaft 22 is connected to the drive unit 15. The blade portion 21 rotates about the axis by rotating the shaft 22 when the drive is transmitted from the drive portion 15. Further, when the shaft 22 is moved in the axial direction 101, the blade portion 21 moves in the internal space of the shaft 11 in the axial direction 101.

As shown in FIGS. 1 and 2, a balloon 23 is provided at a position opposite to the opening 20 with respect to the axis of the shaft 11. The balloon 23 can inflate radially outward from the peripheral wall 25 of the shaft 11, and is folded and adheres to the peripheral wall 25 of the shaft 11 until the catheter 10 is inserted into the blood vessel. .. The material of the balloon 23 is preferably a biocompatible material, and specific examples thereof include polyurethane, polyethylene, polyester, polypropylene, polyamide, polyamide elastomer, polytetrafluoroethylene, and polyvinylidene fluoride.

As shown in FIG. 2, the base end side of the balloon 23 is connected to the balloon tube body 24 provided along the peripheral wall 25 of the shaft 11. The internal space of the balloon tube 24 communicates with the internal space of the balloon 23. The balloon tube 24 extends to the proximal end 14 (see FIG. 1), and the internal space of the balloon tube 24 is connected to the port 41 of the proximal end 14. The balloon 23 is inflated in the blood vessel by the liquid such as physiological saline injected from the port 41 of the proximal end portion 14 flowing into the balloon 23. The tube body 24 for a balloon is a molded body of an elastically deformable soft plastic such as polyamide, polyamide elastomer, and polyether amide.

The details of the tip portion 13 will be described below. As shown in FIG. 2, the tip portion 13 has a blade tube 31, a reduced diameter portion 32, and a tip tip 33.

The blade tube 31 is a circular tube having both sides open. The blade tube 31 is connected to the tip of the intermediate portion 17, and its internal space is communicated with the internal space of the intermediate portion 17.

As shown in FIGS. 1 and 3, the blade tube 31 is reinforced by the core material 34 except for the end portion 37 on the intermediate portion 17 side. The core material 34 is embedded in the peripheral wall of the blade tube 31.

The peripheral wall of the blade tube 31 is made of a material that transmits radiation such as X-rays. In the present embodiment, the peripheral wall is made of an elastically deformable soft plastic such as polyamide, polyamide elastomer, and polyether amide.

The core material 34 of the blade tube 31 is formed into a tubular shape by meshing a metal wire such as medical stainless steel. The wire has a lower transparency of radiation such as X-rays than the peripheral wall (soft plastic) of the blade tube 31.

The end portion 37 of the blade tube 31 (the portion not reinforced by the core material 34) is more permeable to radiation such as X-rays than the portion other than the end portion 37 of the blade tube 31 (the portion reinforced by the core material 34). Is big. The end 37 corresponds to the transmissive portion.

The inner diameter of the blade tube 31 is about the same as the outer diameter of the main body portion 16 and the intermediate portion 17. The blade tube 31 is fitted into the tip of the intermediate portion 17 from the outside. The outer diameter and inner diameter of the blade tube 31 are substantially uniform over the axial direction 101. In the cross-sectional views (FIGS. 2, 4 to 6, 8 and 11), the core material 34 is not shown.

As shown in FIG. 2, the reduced diameter portion 32 is a circular tube having both sides open and the outer diameter reduced in a tapered shape. The reduced diameter portion 32 is connected to the tip of the blade tube 31, and its internal space is communicated with the internal space of the blade tube 31. The reduced diameter portion 32 is made of an elastically deformable soft plastic such as polyamide or polyether amide. The inner diameter of the reduced diameter portion 32 on the base end side is about the same as the outer diameter of the tip of the blade tube 31, and the reduced diameter portion 32 is fitted into the tip of the blade tube 31 from the outside and heat-welded. The inner diameter of the reduced diameter portion 32 on the tip end side is about the same as the outer diameter of the central portion of the tip tip 33. On the tip side of the reduced diameter portion 32, the wall thickness becomes thinner toward the tip side.

The tip tip 33 is a circular tube having openings on both sides and a tapered outer diameter on the base end 36 side. The tip tip 33 is connected to the tip of the reduced diameter portion 32, and its internal space communicates with the internal space of the reduced diameter portion 32. The tip 35 side of the tip tip 33 projects outward in the axial direction 101 from the tip of the reduced diameter portion 32. The base end 36 side of the tip tip 33 extends the internal space of the reduced diameter portion 32 in the axial direction 101. The base end 36 reaches the internal space of the blade tube 31. That is, the diameter-reduced portion 32 from the tip end side portion of the blade tube 31 has a double tube structure in which the blade tube 31 and the diameter-reduced portion 32 are on the outside and the tip tip 33 is on the inside.

The tip tip 33 has an enlarged diameter on the base end 36 side, but the outer diameter and inner diameter of the other parts are substantially equal. The outer diameter of the uniform portion is smaller than the inner diameter of the blade tube 31, and is about the same as the inner diameter of the tip of the reduced diameter portion 32. Further, the diameter of the base end 36 side is expanded, but the maximum diameter thereof is smaller than the inner diameter of the blade tube 31.

The tip 33 is made of an elastically deformable soft plastic such as polyamide or polyetheramide. The tip tip 33 is inserted into the tip of the reduced diameter portion 32 and heat-welded.

As shown in FIGS. 3 and 4A, a plurality of markers 60 are provided on the outer surface 38 of the end portion 37 on the shaft 11 side of the peripheral wall of the blade tube 31.

In this embodiment, two markers (markers 61 and 62) are provided. Hereinafter, the two markers 61 and 62 are collectively referred to as a marker 60. The marker 60 is made of a material having a smaller radiation permeability such as X-rays than the blade tube 31. In this embodiment, the marker 60 is made of gold and is plated on the outer surface 38. The marker 60 is not limited to gold, and may be made of platinum, for example, and may be made of stainless steel having a wall thickness of 0.2 mm or more if there is no limitation on the thickness of the marker 60.

The markers 61 and 62 are adjacent to each other in the circumferential direction 102 of the shaft 11, and are positioned so as not to overlap each other in the circumferential direction 102. Here, the fact that the markers 61 and 62 do not overlap each other in the circumferential direction 102 means that the markers 61 and 62 do not completely overlap in the circumferential direction 102. That is, the markers 61 and 62 may be provided at intervals in the circumferential direction 102, or a part of the marker 61 and a part of the marker 62 may overlap in the circumferential direction 102. In the present embodiment, the markers 61 and 62 are provided at intervals in the circumferential direction 102.

The markers 61 and 62 are adjacent to each other in the axial direction 101 of the shaft 11, and are positioned so as not to overlap each other in the axial direction 101. Here, the fact that the markers 61 and 62 do not overlap each other in the axial direction 101 means that the markers 61 and 62 do not completely overlap in the axial direction 101. That is, the markers 61 and 62 may be provided at intervals in the axial direction 101, or a part of the marker 61 and a part of the marker 62 may overlap in the axial direction 101. In the present embodiment, the base end portion of the marker 61 and the tip end portion of the marker 62 overlap in the axial direction 101. In other words, as shown in FIG. 3, in the axial direction 101, the end 611 on the proximal end side of the marker 61 is located closer to the proximal end side of the shaft 11 than the distal end 621 of the marker 62.

As shown in FIG. 4A, the length L1 of the marker 61 in the circumferential direction 102 is equal to the length L2 of the marker 62 in the circumferential direction 102. The length L1 may be different from the length L2. The length of the markers 61 and 62 in the circumferential direction 102 is preferably short from the viewpoint of easy recognition of the circumferential angle of the catheter 10 by the user. In particular, the length of the markers 61 and 62 in the circumferential direction 102 is preferably in the range of 0.3 to 0.8 mm.

The lengths L1 and L2 are arbitrary. However, the lengths L1 and L2 are such that there is a gap between the marker 61 and the marker 62 in the circumferential direction 102 (in other words, there is a portion where the outer surface 38 of the end portion 37 of the blade tube 31 is exposed). Is preferable.

The markers 61 and 62 differ in the circumferential angle of the blade tube 31 with respect to the axis by 90 degrees. Specifically, in the line of sight along the axial direction 101, the line 81 connecting the center of the marker 61 in the circumferential direction 102 and the axis 103 of the shaft 11 and the center of the marker 62 in the circumferential direction 102 and the axis 103 are connected. The angle θ1 formed with the line 82 is 90 degrees. The angle θ1 is not limited to 90 degrees and may be, for example, 45 degrees.

The length L3 of the marker 61 in the axial direction 101 is different from the length L4 of the marker 62 in the axial direction 101. In this embodiment, the length L3 is shorter than the length L4. The length L4 may be shorter than the length L3. Further, the lengths L3 and L4 may have the same length.

As shown in FIG. 3, any one of the markers 60 (marker 62 in this embodiment) is in the same position as the opening 20 in the circumferential direction 102.

As shown in FIG. 1, a base end portion 14 is provided at the base end of the shaft 11. The base end portion 14 is a tubular member having an internal space continuous with the internal space of the shaft 11. The base end portion 14 is a molded body of a resin such as polypropylene or ABS. The base end portion 14 can serve as a handle in operations such as when inserting and removing the shaft 11 into a blood vessel.

The base end portion 14 is provided with a port 41 extending in a direction intersecting the axial direction 101. Another device such as a syringe is connected to the port 41, and a fluid such as physiological saline flowing in and out from the other device flows in and out from the proximal end portion 14 to the balloon tube body 24. The base end portion 14 may be provided with another port continuous with the internal space of the shaft 11. Such a port is used, for example, for the purpose of recovering an excised porridge that has entered the inside of the shaft 11.

The shaft 22 of the cutter 12 extends from the opening on the base end side of the base end portion 14, and the drive unit 15 is connected to the shaft 22. The drive unit 15 incorporates a motor, a battery, and the like. The rotation of the motor of the drive unit 15 is transmitted to the shaft 22.

By rotating the vicinity of the base end portion 14 of the shaft 11 or the base end portion 14 itself, the rotation is transmitted to the intermediate portion 17 and the tip portion 13 of the shaft 11, and the intermediate portion 17 and the tip portion 13 are rotated. To.

[How to use the catheter 10]
Hereinafter, how to use the catheter 10 will be described with reference to FIGS. 5 and 6. In the following description, the descriptions of "top" and "bottom" refer to "top" and "bottom" of the referenced figure.

The catheter 10 is used when excising the porridge 51 formed on the inner wall of the blood vessel 50. The catheter 10 is inserted into the blood vessel 50 from the tip portion 13 with the balloon 23 contracted (see FIGS. 1 and 3). Although not shown in FIGS. 5 and 6, a guide wire is inserted into the blood vessel 50 in advance when the catheter 10 is inserted into the blood vessel 50. The insertion of the guide wire into the blood vessel 50 is performed by a known method. The guide wire inserted into the blood vessel 50 is inserted in this order from the internal space of the tip 33 of the tip 13 into the internal space of the shaft 11, the through hole of the blade 21 of the cutter 12, and the internal space of the shaft 22. The catheter 10 is inserted into the blood vessel 50 from the tip portion 13.

At a location where the blood vessel 50 is curved, such as a coronary artery, the tip 13 is elastically curved along the guide wire and advanced to the porridge 51 of the blood vessel 50. When the tip portion 13 reaches the porridge 51 and the opening 20 of the shaft 11 faces the porridge 51, the insertion of the shaft 11 into the blood vessel 50 is completed.

In the process of inserting the shaft 11 into the blood vessel 50, radiation (X-rays in this embodiment) is emitted from outside the patient's body, so that the tip portion 13 and the intermediate portion 17 of the shaft 11 inside the patient's body are exposed to X-rays. Be photographed. The marker 60 and the intermediate portion 17 are less transparent to X-rays than the end portion 37 of the blade tube 31. Therefore, in the X-ray photographed image, the marker 60 can be identified by the contrast between the marker 60 and the end portion 37, and is provided in the intermediate portion 17 and the intermediate portion 17 by the contrast between the intermediate portion 17 and the end portion 37. The opening 20 is identifiable. By recognizing the relative positional relationship between the markers 61 and 62, the position and posture of the shaft 11 can be recognized from outside the patient's body. Further, by recognizing the relative positional relationship between the markers 61 and 62 and the opening 20, the position and posture of the opening 20 can be recognized from outside the patient's body.

For example, when the shaft 11 is in the posture shown in FIG. 4 (A) and X-rays are emitted from the left side of the paper surface of FIG. 4 (A) toward the shaft 11, the X-ray-photographed marker 61, 62 is displayed in the positional relationship shown in FIG. 7 (A). In FIG. 7 (A), the marker 60 and the intermediate portion 17 having low X-ray transparency are displayed with dark shadows (indicated by hatching in FIG. 7 (A)), and the X-ray transparency is high. The marker 60 and the end portion 37 larger than the intermediate portion 17 are displayed with a light shadow. Depending on the transparency of X-rays, the end portion 37 may not be displayed, but in this description, it is displayed as a light shadow and is shown as an unhatched portion in the figure.

Here, the position of the opening 20 can be recognized by the displayed intermediate portion 17. For example, when the intermediate portion 17 is displayed as shown in FIG. 7A, it can be recognized that the portion recessed downward from the upper end is the opening 20, so that the opening 20 faces upward in this case. Can be recognized as. However, the recessed portion is not always clearly displayed, and when the recessed portion is not clearly displayed, the position of the opening 20 cannot be recognized by the displayed intermediate portion 17.

In this case, the position of the opening 20 can be recognized based on the displayed markers 61 and 62.

For example, the position in the circumferential direction of the marker 60 when the two markers 61 and 62 are aligned in the axial direction 101 can be recognized as the reference position of the opening 20. It will be described in detail below. The shaft 11 is rotated so that the two markers 61 and 62 are aligned while the markers 61 and 62 displayed by X-ray photography are visually recognized. For example, when the shaft 11 is rotated clockwise in FIG. 4 (A) from the posture shown in FIG. 4 (A) to the posture shown in FIG. 8 (A), the photographed markers 61 and 62 are shown in FIGS. It is displayed in the positional relationship shown in 7 (B). That is, the marker 61 moves upward from the time shown in FIG. 7 (A), and the marker 62 moves vertically longer than the case shown in FIG. 7 (A) by moving to the back side of the irradiation. When the shaft 11 is rotated clockwise in FIG. 8 (A) from the posture shown in FIG. 8 (A), the marker 61 moves upward from the posture shown in FIG. 8 (A), and the marker 62 moves upward in FIG. It moves downward from the time of (A). Then, when the markers 61 and 62 are in the same position in the vertical direction, that is, when the shaft 11 is in the posture shown in FIG. 8 (B), the X-ray-photographed markers 61 and 62 are shown in FIG. 7 (C). ) Is displayed in the positional relationship shown in). That is, the two markers 61 and 62 are aligned in the axial direction 101. At this time, it can be recognized that the opening 20 is located at the same position in the vertical direction as the markers 61 and 62 that are in a straight line.

When the markers 61 and 62 are aligned in the axial direction 101, the positions of the markers 61 and 62 are shown by a solid line in FIG. 8 (B) and a broken line in FIG. 8 (B). There are two possible cases, one is the position where the position is set. However, as in the present embodiment, when the circumferential angle of the blade tube 31 with respect to the axis is different by 90 degrees between the markers 61 and 62, which of the two cases is shown in FIG. 8 (B). It can be identified by slightly rotating the shaft 11 from the indicated posture. For example, when the shaft 11 is slightly rotated clockwise in FIG. 8B, the marker 62 is displayed to be located below the marker 61 (a marker having a long length along the axial direction 101). (When displayed so as to be located below the marker having a short length along the axial direction 101), the positions of the markers 61 and 62 before the slight rotation are the positions shown by the solid lines in FIG. 8 (B). On the other hand, when the marker 62 is displayed so as to be located above the marker 61 when the shaft 11 is slightly rotated clockwise in FIG. 8 (B) (a marker having a long length along the axial direction 101 is displayed. (When displayed so as to be located above the marker having a short length along the axial direction 101), the positions of the markers 61 and 62 before the slight rotation are the positions shown by the broken lines in FIG. 8 (B). In the present embodiment, since the marker 62 is at the same position as the opening 20 in the circumferential direction 102, the positions of the markers 61 and 62 that are in a straight line can be recognized as the position of the opening 20 (the circumferential angle of the opening 20). it can. Specifically, when the positions of the markers 61 and 62 are the positions shown by the solid lines in FIG. 8B, the circumferential angle θ2 of the opening 20 with respect to the upper end of the shaft 11 is 45 degrees.

The position of the opening 20 when the circumferential angle is θ2 (45 degrees in this example) is set as a reference position, and the opening 20 can be set to the intended position and orientation by rotating the shaft 11 from the reference position. For example, when the opening 20 is to be directed directly upward, the shaft 11 is rotated 45 degrees counterclockwise from the posture shown by the solid line in FIG. 8 (B), or from the posture shown by the broken line in FIG. 8 (B). It suffices to rotate 135 degrees clockwise, and when the opening 20 is to be directed directly downward, the shaft 11 is rotated 135 degrees clockwise from the posture shown by the solid line in FIG. 8 (B), or is rotated 135 degrees in FIG. 8 (B). It suffices to rotate 45 degrees counterclockwise from the posture shown by the broken line. These angles (45 degrees and 135 degrees) can be grasped by the feeling of the user's hand holding the shaft 11 and the change in the shape and position of the markers 61 and 62 as described later.

The means for recognizing the position of the opening 20 is not limited to the above-mentioned means (means for rotating the shaft 11 so that the markers 61 and 62 are aligned in the axial direction 101).

For example, when the shaft 11 is rotated, the length and position of the marker 62 visually recognized by the user in the vertical direction (vertical direction of the paper surface in FIG. 7) changes, but the displayed marker 62 is the most in the vertical direction. When shortened, the opening 20 is located at the upper end of the shaft 11 and faces straight up (see FIG. 7A), or the opening 20 is located at the lower end of the shaft 11 and points straight down. You can recognize that you are. Further, for example, when the marker 62 is the longest in the vertical direction, it can be recognized that the opening 20 faces the front or the back in the irradiation direction.

Further, by identifying the position of the displayed marker 62 relative to the marker 61, it is possible to recognize which side the opening 20 is facing up or down. For example, as shown in FIG. 7A, when the marker 62, which is the shortest in the vertical direction, is located above the marker 61, the opening 20 is located at the upper end of the shaft 11 and faces upward. It is recognizable. On the other hand, when the marker 62, which is the shortest in the vertical direction, is located below the marker 61, it can be recognized that the opening 20 is located at the lower end of the shaft 11 and faces downward.

As described above, the shaft 11 so that the opening 20 has an appropriate circumferential angle (in other words, the opening 20 faces the porridge 51) while visually recognizing the image of the marker 60 displayed by the photographing. Is rotated. After that, the guide wire is pulled out from the proximal end 14 side of the catheter 10. Further, the drive unit 15 is connected to the shaft 22 of the cutter 12.

As shown in FIG. 5, in a state where the opening 20 of the shaft 11 faces the porridge 51, the balloon 23 in the contracted state is expanded by the fluid flowing from the port 41 into the balloon tube body 24. When the expanded balloon 23 abuts on the inner wall of the blood vessel 50 on the opposite side of the porridge 51, the opening 20 is brought into close contact with the porridge 51, and a part of the porridge 51 moves from the opening 20 to the internal space of the shaft 11. In the entered state, the catheter 10 is fixed to the blood vessel 50.

Subsequently, the motor of the drive unit 15 is driven, and the blade unit 21 is rotated through the shaft 22 of the cutter 12. On the base end 14 side, the shaft 22 advances toward the tip side in the axial direction 101 with respect to the shaft 11, so that the rotating blade 21 comes into contact with the porridge 51, and the porridge 51 is excised by the blade 21. (See FIG. 6). The excised piece 52 of the porridge tumor 51 enters the internal space of the blade tube 31 through the internal space of the shaft 11. When the excision of the porridge 51 is completed, the balloon 23 is contracted, and the catheter 10 is pulled out from the blood vessel 50 and withdrawn.

[Action and effect of this embodiment]
According to the present embodiment, the rotational posture around the axis of the catheter 10 can be easily recognized by the positional relationship of the markers 61 and 62 (for example, whether or not the edges of the markers 61 and 62 are in a straight line). be able to.

Further, according to the present embodiment, the rotational posture around the axis of the catheter 10 can be easily recognized by the degree of overlap or separation of the two markers 61 and 62 adjacent to each other in the circumferential direction 102.

Further, according to the present embodiment, when the rotational posture around the axis of the catheter 10 becomes a predetermined circumferential angle, two markers 61 and 62 adjacent to each other in the axial direction 101 become one continuous marker. appear. As a result, it can be recognized that the rotational posture around the axis of the catheter 10 has become a predetermined circumferential angle.

Further, according to the present embodiment, the markers 61 and 62 can be easily identified by the difference in length in the axial direction 101. In particular, depending on the irradiation conditions such as the irradiation direction, the relative positional relationship of each marker may be unclear due to the shadow of one of the markers being displayed faintly. Even in this case, it is possible to determine which marker is the marker displayed in the dark shadow based on the difference in the length of the marker in the axial direction.

Further, according to the present embodiment, since the marker 62 is at the same position as the opening 20 in the circumferential direction 102, the position of the opening 20 can be easily recognized.

[Modification example]
In the above embodiment, the markers 61 and 62 are individually configured, but the plurality of markers 60 may be integrally configured. Further, the markers 61 and 62 may be attached to the blade tube 31 by means other than plating.

For example, as shown in FIG. 9, the markers 61 and 62 may be integrally configured by being connected by a plurality of rings. In FIG. 9, the markers 61 and 62 are integrally configured by the ring 90 (first ring 91, second ring 92, and third ring 93).

The first ring 91, the second ring 92, and the third ring 93 are provided at intervals in the axial direction 101. The marker 61 is located between the first ring 91 and the second ring 92. The marker 61 is connected to the first ring 91 at the distal end 612 in the axial direction 101. The marker 61 is connected to the second ring 92 at the end 611 on the proximal end side in the axial direction 101. The marker 62 is located between the second ring 92 and the third ring 93. The marker 62 is connected to the second ring 92 at the distal end 621 in the axial direction 101. The marker 62 is connected to the third ring 93 at the end 622 on the proximal end side in the axial direction 101.

The blade tube 31 of the markers 61, 62 and the ring 90 (first ring 91, second ring 92, and third ring 93) integrated as described above is inserted into the ring 90. Thereby, it is attached to the blade tube 31. The ring 90 is fixed to the blade tube 31 by adhesion or the like. The ring 90 (first ring 91, second ring 92, and third ring 93) extends along the circumferential direction 102 in a state of being attached to the blade tube 31.

The configuration of the marker 60 and the ring 90 is not limited to the configuration shown in FIG.

The number of rings 90 is not limited to three. For example, as shown in FIG. 13 (A), markers 61 and 62 may be connected to one ring 90. In this case, the marker 61 is connected to the ring 90 at the proximal end 611 in the axial direction 101, and the marker 62 is connected to the ring 90 at the distal end 621 in the axial direction 101.

Further, each marker 60 may be connected to the ring body 90 via another marker 60. For example, as shown in FIG. 13B, the distal end 612 of the marker 61 in the axial direction 101 is connected to the ring 90, and the angle of the proximal end 611 of the marker 61 in the axial direction 101. The portion may be connected to the corner portion of the end 621 on the distal end side in the axial direction 101 of the marker 62. In this case, the marker 62 is indirectly connected to the ring body 90 via the marker 61, and the marker 61 is directly connected to the ring body 90 without via another marker 60.

Further, the ring body 90 is not limited to the one that extends straight as shown in FIGS. 9 and 13. For example, the ring 90 and the markers 61, 62 may be configured as shown in FIG. 14 (A). In the case of the configuration shown in FIG. 14A, a part of the ring body 90 extends while being bent, and the markers 61 and 62 are connected to the bent portion of the ring body 90. The ring 90 extends from the position 94 to the back side of the outer surface 38 in FIG. 14A and reaches the position 95.

Further, the number of markers 60 is not limited to two, and the markers 60 and the ring 90 may have various configurations other than those shown in FIGS. 13 and 14 (A). For example, the marker 60 and the ring 90 have a configuration consisting of four markers 60 and two rings 90 as shown in FIG. 14 (B), or four markers 60 and four rings as shown in FIG. It may be composed of a body 90.

In the case of the configuration including the ring 90, the marker 60 is preferably configured to be thicker than the ring 90, or the surface is preferably plated with another material. For example, when the marker 60 and the ring 90 are made of stainless steel, the marker 60 portion is gold-plated. This improves the visibility of the marker 60. In addition, the marker 60 and the ring 90 can be easily distinguished from each other.

In the above-described configuration, the marker 60 and the ring 90 are integrally configured. That is, the marker 60 and the ring 90 were made of the same material. However, the marker 60 and the ring 90 may be made of different materials. For example, a marker 60 made of stainless steel may be fitted in a ring body 90 made of resin.

According to the configuration shown in FIG. 9, since the plurality of markers 60 are integrally configured through the ring body 90, the positional deviation between the markers 60 can be reduced. That is, the relative positions between the markers 60 are maintained in a predetermined relationship (for example, in the above embodiment, the circumferential angles of the markers 61 and 62 are 90 degrees). Since the ring 90 is formed over the entire circumference of the blade tube 31, it is possible to prevent the ring 90 and each marker 60 from coming off the blade tube 31.

In the above embodiment, two markers 60 (markers 61 and 62) are provided, but the number of markers 60 is not limited to two. For example, as shown in FIG. 10, three markers 60 (markers 63, 64, 65) may be provided. In this case, the markers 63 and 64 are adjacent to each other in the axial direction 101 and the circumferential direction 102, and the markers 64 and 65 are adjacent to each other in the axial direction 101 and the circumferential direction 102. Then, in the adjacent markers 63 and 64, the same position and size relationship as the markers 61 and 62 in the above embodiment is established. Further, in the adjacent markers 64 and 65, the same position and size relationship as those of the markers 61 and 62 in the above embodiment are established.

In the above embodiment, the marker 60 is arranged at the end portion 37 on the shaft 11 side of the peripheral wall of the blade tube 31 (the portion of the blade tube 31 that is not reinforced by the core material 34). However, the place where the marker 60 is provided is not limited to the end portion 37. For example, the marker 60 may be provided on a portion of the blade tube 31 that is reinforced by the core material 34. However, from the viewpoint of improving visibility, it is desirable that the marker 60 is arranged at a position near the opening 20 and at a position where there is no such thing as stainless steel that obstructs the visibility of the marker 60.

As shown in FIG. 11, the catheter 10 may include a support 70. The support 70 is made of a material (for example, gold) whose transparency of radiation such as X-rays is smaller than that of the blade tube 31. The support 70 is arranged in the vicinity of the end portion 37 in the internal space of the shaft 11.

As shown in FIG. 4B, the support 70 is arranged at a position opposite to the opening 20 with respect to the axis 103 of the shaft 11. That is, the angle formed by the support 70 and the marker 62 (specifically, the line 83 connecting the center of the support 70 in the circumferential direction 102 and the axis 103, and the center of the marker 62 in the circumferential direction 102 and the axis 103 are connected. The angle formed by the parallel line 84) is 180 degrees. Further, the angle formed by the support 70 and the marker 61 (specifically, the line 83 connecting the center of the support 70 in the circumferential direction 102 and the axis 103, and the center of the marker 61 in the circumferential direction 102 and the axis 103 are connected. The angle formed by the parallel line 85) is 90 degrees. The position of the support 70 in the circumferential direction 102 is not limited to the above position.

As shown in FIGS. 4B and 11, the support 70 has a through hole 71 through which the guide wire is passed.

As shown in FIG. 11, the guide wire 72 passes through the internal space of the shaft 22 and the through hole of the blade portion 21 and reaches the portion of the internal space of the shaft 11 facing the opening 20. At this portion, the guide wire 72 is inserted into the through hole 71 of the support 70. As a result, the support 70 supports the guide wire 72.

When the catheter 10 includes the support 70 as described above and the support 70 is arranged in the internal space of the end 37, the support 70 can be used as a marker. For example, when the shaft 11 is in the posture shown in FIG. 4 (B) and X-rays are emitted from the left side of the paper surface of FIG. 4 (B) toward the shaft 11, the photographed markers 61 and 62 are , Is displayed in the positional relationship shown in FIG. In this case, similarly to the above embodiment, the posture of the shaft 11 and the position of the opening 20 can be recognized by the mutual positional relationship between the marker 61, the marker 62, and the support 70, but the support 70 is added. Therefore, the recognition becomes easier. As shown in FIG. 12, the support 70 can be distinguished from the markers 61 and 62 by making the shape of the support 70 different from the markers 61 and 62.

The markers 61 and 62 in the above embodiment may be fixed to the end 37 by, for example, the following method.

As shown in FIG. 16, platinum markers 61 and 62 are attached to the stainless steel support 110, respectively. The markers 61 and 62 may be made of stainless steel, but since they are made of platinum, the visibility in the X-ray photographed image is excellent.

As shown in FIG. 6A, the support 110 has a band-shaped main body 111 and two band-shaped branch bodies 112 and 113 extending from the main body 111. The longitudinal direction of the main body 111 and the longitudinal direction of the branches 112 and 113 are orthogonal to each other. The dimension along the longitudinal direction of the branch body 112 is shorter than the dimension along the longitudinal direction of the branch body 113.

The markers 61 and 62 are each configured as a platinum tube. As shown in FIG. 16B, the end of the branch body 112 is inserted into the internal space of the tube of the marker 61. The end of the branch body 113 is inserted into the internal space of the tube of the marker 62. Then, the markers 61 and 62 are fixed to the branches 112 and 113 by crushing the tube shape by pressing the markers 61 and 62, respectively.

As shown in FIG. 16C, the main body 111 is formed into an annular shape by connecting both ends in the longitudinal direction. The inner diameter of the annular main body 111 is smaller than the outer diameter of the end portion 37 and larger than the inner diameter.

As shown in FIG. 17 (A), the end portion 37 includes an inner pipe 37A and an outer pipe 37B. The outer diameter of the inner pipe 37A is equivalent to the inner diameter of the annular main body 111. In the support 110 shown in FIG. 16C, the annular main body 111 is fitted along the outer circumference of the inner pipe 37A. As a result, the main body 111 extends along the circumferential direction of the inner pipe 37A, and the branch bodies 112 and 113 extend parallel to the axial direction of the inner pipe 37A (corresponding to the axial direction 101), respectively. Further, the markers 61 and 62 are located at predetermined positions on the outer peripheral surface of the inner pipe 37A. That is, the markers 61 and 62 have the positional relationship shown in FIG.

As shown in FIG. 17B, the support 110 and the markers 61 and 62 are sandwiched between the inner tube 37A and the outer tube 37B by fitting the outer tube 37B to the outside of the inner tube 37A. Then, the inner pipe 37A and the outer pipe 37B are integrally fixed by heating to become the end portion 37, and the gaps between both end surfaces of the inner pipe 37A and both end surfaces of the outer pipe 37B are sealed to form the end portions 37. Become. In this way, the markers 61, 62 are fixed to the end 37.

In the above embodiment, the radiation transmission of the marker 60, the intermediate portion 17, and the support 70 was smaller than the radiation transmission of the blade tube 31. However, contrary to the above embodiment, the radiation permeability of the marker 60, the intermediate portion 17, and the support 70 may be larger than the radiation transmission of the blade tube 31. That is, the radiation transmission of the marker 60, the intermediate portion 17, and the support 70 may be different from the radiation transmission of the blade tube 31. Due to the different permeability, the marker 60, the intermediate portion 17, and the support 70 can be identified by the contrast with respect to the blade tube 31.

In the above embodiment, the tip portion 13 has the blade tube 31, but the tip portion 13 is not limited to the blade tube 31. For example, the tip portion 13 may have a transparent and flexible resin tube instead of the blade tube 31.

In the above embodiment, the catheter 10 is for excision of porridge, but may be used for purposes other than excision of porridge.

For example, the catheter may be a suction catheter inserted into a trachea or a blood vessel, a catheter for penetrating a vascular stenosis, or a catheter for penetrating a coronary artery. Many such catheters have a side hole, a needle, or the like at the tip. In this case, it is possible to adjust the rotational posture around the axis of the catheter in order to make the direction in which the side hole and the needle open are correct by providing the configuration of the above embodiment.

Also, for example, the catheter may be one used for catheter ablation. Many such catheters have electrodes or balloons at the tips. In this case, it is possible to adjust the rotational posture around the axis of the catheter in order to correct the orientation and position of the electrodes and balloons by providing the configuration of the above embodiment.

10 Catheter 17 Intermediate part (cylindrical part)
20 Aperture 23 Balloon 25 Peripheral wall 31 Blade tube (transmissive part)
61 Marker 62 Marker 70 Support 91 First ring 92 Second ring 93 Third ring 101 Axial direction 102 Circumferential direction

Claims (9)

A shaft with a cylindrical transmission part that allows radiation to pass through,
It is located in the transmission part and has at least two markers having different radiation transmission properties from the transmission part.
Each of the markers is a catheter located at a position where the transmissive portion does not overlap with each other in the axial direction and the circumferential direction. The catheter according to claim 1, wherein the two markers adjacent to each other in the circumferential direction have different circumferential angles of 90 degrees with respect to the axis of the transmissive portion. The catheter according to claim 1 or 2, wherein each marker has the same length along the circumferential direction. The catheter according to claim 3, wherein the two markers adjacent to each other in the axial direction partially overlap in the axial direction. The catheter according to any one of claims 1 to 4, wherein the two markers adjacent to each other in the axial direction have different lengths along the axial direction. It has a ring that extends in a ring shape along the circumferential direction.
The catheter according to any one of claims 1 to 5, wherein each marker is directly connected to the ring body indirectly through the other marker or not through the other marker. A cylindrical portion that is located at a different position in the axial direction from the transmissive portion and has different radiation permeability from the transmissive portion.
An opening formed in a part of the peripheral wall of the cylindrical part,
A cutter that can move along the axial direction while rotating around the axis of the shaft in the internal space of the cylindrical portion.
The catheter according to any one of claims 1 to 6, further comprising a balloon which is located on the side opposite to the opening with respect to the axis of the cylindrical portion and bulges outward in the radial direction of the shaft. The catheter according to claim 7, wherein any one of the plurality of markers is located at the same position as the opening in the circumferential direction. It is located in the internal space of the shaft and further includes a support through which a guide wire passing through the internal space is inserted.
The catheter according to claim 7 or 8, wherein the support has a different radiation permeability from the transmitting portion.

Images