Supported Devices

Abstract

To suppress a medical device stored in the inside from coming off in a support device that can give a backup force to the medical device without extracting the medical device inserted into an organism lumen.SOLUTION: A support device that supports a medical device includes a shaft part having a long-sized outer shape, and a thin plate arranged at the tip of the shaft part. The thin plate is constituted from an elastic metal, has a dent part extending in a direction crossing the longitudinal direction of the shaft part, and is deformed to an almost cylindrical shape by warping the thin plate to the dent part in a direction of solving indentation.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a support device for supporting a medical device. [Background technology]

[0002] A procedure for dilating stenotic or occlusive lesions in the coronary arteries of the heart from the inside of the blood vessel (hereinafter referred to as "PCI (percutaneous transluminal coronary intervention)") is known. In PCI, for example, a balloon catheter equipped with an expandable balloon is used to dilate the stenotic lesion and ensure blood flow. In such a procedure, there have been cases where the balloon becomes stuck at a vascular bifurcation due to insufficient backup force of the balloon catheter, making it impossible to deliver the balloon to the stenotic lesion. For example, Patent Documents 1 and 2 disclose guide extension catheters that can supplement the backup force of a balloon catheter by storing the balloon catheter inside. Furthermore, Patent Document 3 discloses a balloon outer diameter adjuster for a dilation catheter that can greatly expand the diameter of the balloon catheter. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Special Publication No. 2015-524737 [Patent Document 2] US Patent Application Publication No. 2019 / 0358434 [Patent Document 3] Japanese Patent Application Publication No. 5-208050 Summary of the Invention [Problem to be solved by the invention]

[0004] Here, the proximal end of the balloon catheter is usually provided with a large-diameter connector for the surgeon to grasp or insert a drug or a concomitant device. Therefore, in order to apply backup force to a balloon catheter that has been inserted into the body and delivered to the vicinity of the stenosis using the guide extension catheter described in Patent Document 1, the balloon catheter must be removed from the body, which poses a problem of requiring time and effort.

[0005] In this regard, with the guide extension catheter described in Patent Document 2, the balloon catheter can be housed inside the guide extension catheter via an exchange channel that communicates between the inside and outside of the tubular body, without the need to remove the balloon catheter. However, the guide extension catheter described in Patent Document 2 has the problem that when the guide extension catheter is delivered to a stenotic site inside the body, the balloon catheter may pop out of the exchange channel (in other words, the balloon catheter may become detached from the guide extension catheter). This problem is particularly pronounced when the guide extension catheter bends at a blood vessel bifurcation and the exchange channel expands.

[0006] Furthermore, the balloon outer diameter adjuster for a dilatation catheter described in Patent Document 3 allows the balloon catheter to be housed inside the balloon outer diameter adjuster for a dilatation catheter without removing the balloon catheter. However, Patent Document 3 only aims to expand the balloon diameter and does not consider supplementing the backup force of the balloon catheter. This problem is not limited to PCI using a balloon catheter, but is a common problem in all cases where it is desired to provide a backup force later to a medical device that is inserted into a biological lumen for use, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs.

[0007] The present invention has been made to solve at least some of the above-mentioned problems, and aims to prevent a medical device housed inside a support device that can apply a backup force to a medical device inserted into a biological lumen without removing the medical device. [Means for solving the problem]

[0008] The present invention has been made to solve at least part of the above-mentioned problems, and can be realized in the following aspects.

[0009] (1) According to one aspect of the present invention, there is provided a support device for supporting a medical device, the support device comprising: a shaft portion having an elongated outer shape; and a thin plate disposed at the distal end of the shaft portion, the thin plate being formed of an elastic metal and having a recess extending in a direction intersecting the longitudinal direction of the shaft portion; the thin plate being deformed into a substantially cylindrical shape by warping the thin plate relative to the recess in a direction that eliminates the recess.

[0010] According to this configuration, the support device includes a thin plate disposed at the distal end of the shaft portion. The thin plate is made of an elastic metal and has a recess extending in a direction intersecting the longitudinal direction of the shaft portion. The thin plate is deformed into a substantially cylindrical shape by warping the thin plate in a direction that eliminates the recess. Therefore, even if a medical device such as a balloon catheter has already been inserted into a biological lumen, the medical device can be accommodated inside (in the lumen) of the cylindrical thin plate by placing the medical device on one of its main surfaces and deforming the thin plate into a substantially cylindrical shape. As a result, the cylindrical thin plate can support the medical device and provide backup force to the medical device. Furthermore, unlike conventional guide extension catheters, the cylindrical thin plate does not have an exchange channel communicating the inside and outside of the cylinder (tube body). Therefore, even if the cylindrical thin plate is bent at a blood vessel bifurcation or the like, there is no risk of the medical device jumping out of the exchange channel (in other words, the medical device becoming detached from the support device). As a result, this configuration enables a support device that can apply backup force to a medical device inserted into a biological lumen without removing the medical device, thereby preventing the medical device housed inside from becoming detached.

[0011] (2) In the support device of the above aspect, the axis of the thin plate when deformed into the approximately cylindrical shape may be aligned with the longitudinal direction of the shaft portion. With this configuration, when the thin plate is deformed into an approximately cylindrical shape, its axis is aligned with the longitudinal direction of the shaft portion that is grasped and operated by the surgeon, thereby improving the torque transmission capability of the support device as well as improving usability.

[0012] (3) In the support device of the above form, the thin plate may have a rectangular shape, and the shaft portion may be an end portion of the thin plate in the longitudinal direction and fixed to the center portion of the thin plate in the lateral direction. With this configuration, the shaft portion is fixed to the longitudinal end of the thin plate, which prevents the shaft portion from interfering with the surgeon's operation to eliminate the depression. Also, because the shaft portion is fixed to the center of the lateral side of the thin plate, the surgeon can grasp the medical device such as a balloon catheter and the shaft portion together, improving the usability of the support device.

[0013] (4) In the support device of the above form, the thin plate may have a pair of main surfaces, and at least one of the main surfaces of the thin plate may have a groove portion formed thereon extending in a direction intersecting the longitudinal direction of the shaft portion. According to this configuration, at least one of the main surfaces of the thin plate has a groove extending in a direction intersecting the longitudinal direction of the shaft portion. Therefore, after the thin plate is deformed into a substantially cylindrical shape, at least one of the outer and inner surfaces of the cylindrical thin plate has a groove extending in the circumferential direction. Therefore, when the cylindrical thin plate bends at a blood vessel bifurcation or the like, the groove can be easily used as a starting point for bending. Furthermore, if multiple grooves are formed in the thin plate, the cylindrical thin plate can be made into a bellows-like shape, making it even easier to bend.

[0014] (5) In the support device of the above form, the thin plate may have a pair of main surfaces, and the shaft portion may include a main body portion and a gripping portion provided at the tip of the main body portion for gripping the thin plate, the gripping portion sandwiching the thin plate from the main surfaces on both sides of the thin plate to grip the thin plate. According to this configuration, the shaft portion includes a gripping portion provided at the tip of the main body portion, which grips the thin plate by sandwiching it from both main surfaces of the thin plate. Therefore, compared to when the thin plate and the main body portion are simply joined together, the thin plate and the main body portion can be reliably fixed together with a simple structure.

[0015] (6) In the support device of the above form, the thin plate may have a pair of main surfaces, the shaft portion may have a main body portion and a flat-shaped connecting portion provided at the tip of the main body portion, and the connecting portion may be fixed to one of the main surfaces of the thin plate. According to this configuration, the shaft portion includes a flat connecting portion provided at the tip of the main body portion, and by joining the thin plate and the main body portion at the connecting portion, the joining area between the thin plate and the main body portion can be increased, thereby improving the joining strength between the thin plate and the main body portion compared to when the thin plate and the main body portion are simply joined.

[0016] The present invention can be realized in various forms, such as a support device for supporting a medical device, a shaft portion or thin plate for a support device, a catheter system equipped with a support device, and a method for manufacturing a support device. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 2 is an explanatory diagram illustrating the configuration of a support device according to the first embodiment. [Figure 2] FIG. 2 is an explanatory diagram illustrating the configuration of a thin plate. [Figure 3] 10A and 10B are explanatory diagrams illustrating the configuration of the support device after the thin plate has been deformed into a substantially cylindrical shape. [Figure 4] FIG. 1 is a diagram showing a state in which a balloon catheter is inserted into a coronary artery. [Figure 5] 10A and 10B show attachment of a support device to a balloon catheter. [Figure 6] 10A and 10B are diagrams illustrating the application of a backup force by a support device. [Figure 7] FIG. 10 is an explanatory diagram illustrating the configuration of a support device according to a second embodiment. [Figure 8] 2 is an explanatory diagram illustrating the configuration of a thin plate as viewed from the direction A (FIG. 1). FIG. [Figure 9] FIG. 11 is an explanatory diagram illustrating the configuration of a support device according to a third embodiment. [Figure 10] FIG. 13 is an explanatory diagram illustrating the configuration of a support device according to a fourth embodiment. [Figure 11] FIG. 13 is an explanatory diagram illustrating the configuration of a support device according to a fifth embodiment. [Figure 12] 10A and 10B are explanatory diagrams illustrating the configuration of a gripping portion. DETAILED DESCRIPTION OF THE INVENTION

[0018] First Embodiment 1 is an explanatory diagram illustrating the configuration of a support device 1 according to a first embodiment. The support device 1 is a device that accommodates a balloon catheter and supplements the backup force of the balloon catheter in a procedure for dilating a stenotic or occlusive lesion in a coronary artery of the heart from the inside of the blood vessel (hereinafter referred to as "PCI (percutaneous transluminal coronary intervention)"). PCI is merely one example, and the support device 1 can be used in all cases where it is desired to provide a backup force later to a medical device that is inserted into a body lumen for use, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs.

[0019] As shown in Fig. 1, the support device 1 includes a shaft portion 10 and a thin plate 20. In Fig. 1, an axis O is indicated as a line passing through the center of the shaft portion 10.

[0020] FIG. 1 illustrates X, Y, and Z axes that are orthogonal to each other. The X axis corresponds to the longitudinal direction of the support device 1, the Y axis corresponds to the height direction of the support device 1, and the Z axis corresponds to the width direction of the support device 1. The left side of FIG. 1 (-X axis direction) is referred to as the "distal side" of the support device 1 and each component, and the right side of FIG. 1 (+X axis direction) is referred to as the "proximal side" of the support device 1 and each component. For the support device 1 and each component, the end located on the distal side is referred to as the "distal end," and the distal end and its vicinity are referred to as the "distal portion." Furthermore, the end located on the proximal side is referred to as the "proximal end," and the proximal end and its vicinity are referred to as the "proximal portion." The distal side is inserted into the living body, and the proximal side is operated by an operator such as a doctor. These points are also common to FIG. 1 and subsequent figures.

[0021] The shaft portion 10 is a member having an elongated outer shape and provided on the proximal end side of the support device 1. The shaft portion 10 includes a main body portion 11 and a connecting portion 12. The main body portion 11 has an elongated outer shape and is a solid, approximately cylindrical portion having a substantially constant outer diameter from the distal end to the proximal end. The proximal end of the main body portion 11 is grasped and operated by the surgeon. The connecting portion 12 is a flat portion provided on the distal end of the main body portion 11. The connecting portion 12 can be easily formed by press-processing a portion on the distal end side of the main body portion 11. The connecting portion 12 is fixed to one main surface of the thin plate 20 (the first main surface 21 in the example of FIG. 1). The connecting portion 12 and the thin plate 20 can be fixed by metallurgical joining such as fusion welding, pressure welding, or brazing, or by adhesive joining using any adhesive. Note that the entire shaft portion 10, or at least a portion thereof, may be provided with a tapered diameter portion in which the outer diameter decreases from the proximal end to the distal end. The outer diameter and length of the shaft portion 10 can be determined arbitrarily.

[0022] The shaft portion 10 preferably has antithrombogenicity, flexibility, and biocompatibility, and can be formed, for example, from stainless steel alloys such as SUS302, SUS304, and SUS316, superelastic alloys such as NiTi alloys, radiolucent alloys such as piano wire, nickel-chromium alloys, and cobalt alloys, or radiopaque alloys such as gold, platinum, tungsten, and alloys containing these elements (e.g., platinum-nickel alloys). The shaft portion 10 may also be formed from resin materials such as polyamide resin, polyolefin resin, polycarbonate resin, polypropylene resin, polyester resin, polyurethane resin, silicone resin, and fluororesin.

[0023] FIG. 2 is an explanatory diagram illustrating the configuration of the thin plate 20. FIG. 2(A) illustrates the configuration of the thin plate 20 as viewed from direction A in FIG. 1. FIG. 2(B) illustrates the configuration of the thin plate 20 as viewed from direction B in FIG. 1 after it has been deformed into a substantially cylindrical shape. As shown in FIG. 1, the thin plate 20 is fixed to the tip end of the shaft portion 10 (specifically, the portion where the connecting portion 12 is provided). As shown in FIGS. 1 and 2(A), the thin plate 20 is a rectangular plate member having a pair of main surfaces 21 and 22. Hereinafter, one of the main surfaces of the thin plate 20 will be referred to as the "first main surface 21," and the other main surface located opposite the first main surface 21 will also be referred to as the "second main surface 22." Also, as shown in Figure 1, when the thin plate 20 is viewed from the first main surface 21 side, of the four ends (in other words, the four sides) located around the thin plate 20, the ends extending along the longitudinal direction (X-axis direction) of the shaft portion 10 are also referred to as "end 201" and "end 202".

[0024] The thin plate 20 is made of an elastic metal. Here, the degree of elasticity of the elastic metal can be measured, for example, by its modulus of elasticity (Young's modulus) or elastic deformability. Examples of elastic metals that can be used include NiTi alloys and steel, and products such as GUMMETAL (registered trademark).

[0025] The thin plate 20 has a recessed portion 29 extending in a direction intersecting the longitudinal direction (X-axis direction) of the shaft portion 10. In the example of FIG. 1, the recessed portion 29 extends in the Z-axis direction, which is a direction intersecting and perpendicular to the longitudinal direction of the shaft portion 10. In the illustrated example, a line passing through the center of the recessed portion 29 (the two-dot chain line in FIG. 1) intersects perpendicularly with the longitudinal direction of the shaft portion 10. However, the line passing through the center of the recessed portion 29 does not have to be perpendicular as long as it intersects with the longitudinal direction of the shaft portion 10. Also, as shown in FIG. 2(A), in the recessed portion 29, both the first main surface 21 and the second main surface 22 are U-shaped and curved in the −Y-axis direction compared to other portions. The linear length L22 from the first main surface 21 located furthest in the +Y-axis direction to the second main surface 22 located furthest in the −Y-axis direction is also referred to as the “recess depth L22.” The recess depth L22 may be determined arbitrarily. The thin plate 20 is deformed into a substantially cylindrical shape as shown in Fig. 2(B) by warping the thin plate 20 in a direction that eliminates the recess 29 (i.e., the direction indicated by the white arrow in Fig. 2(A), the +Y-axis direction).

[0026] FIG. 3 is an explanatory diagram illustrating the configuration of the support device 1 after the thin plate 20 has been deformed into a substantially cylindrical shape. The deformed thin plate 20 (hereinafter also referred to as the "cylindrical thin plate 20") has a substantially cylindrical shape centered on an axis O20. Here, the axis O20 of the cylindrical thin plate 20 is along the longitudinal direction of the shaft portion 10. In other words, the axis O20 of the cylindrical thin plate 20 and the axis O passing through the center of the shaft portion 10 both extend along the X-axis direction. As shown in FIG. 3, the cylindrical thin plate 20 is tubular, having a distal opening 20a at its distal end and a proximal opening 20b at its proximal end. The inside (lumen) of the cylindrical thin plate 20 functions as a device lumen 20L for accommodating a medical device such as a balloon catheter.

[0027] As shown in FIG. 2(B), the cylindrical thin plate 20 has its end portions 201 and 202 overlapping each other. The extent of the overlap, in other words, the angle θ formed by the end portions 201 and 202 with respect to the axis O20, can be determined arbitrarily. However, from the viewpoint of preventing the medical device housed in the device lumen 20L from slipping out and maintaining flexibility, the angle θ is preferably 90 degrees or more and 270 degrees or less. The cylindrical thin plate 20 is biased in the direction of the black arrow shown in FIG. 2(B) (i.e., the circumferential direction). Therefore, the inner diameter Φ20 of the cylindrical thin plate 20 can be enlarged or reduced depending on the diameter of the medical device housed in the device lumen 20L. For example, if the medical device has a relatively large diameter, the inner diameter Φ20 will be relatively large depending on the outer diameter of the medical device.

[0028] The thin plate 20 that deforms in this manner can be produced, for example, as follows. First, a rectangular plate member made of elastic metal is prepared. The elastic metal plate member is wrapped around a metal tubular body having a predetermined outer diameter and then heat-treated. As a result, the elastic metal plate member becomes a generally cylindrical shape as shown in FIGS. 2(B) and 3. Then, a recess 29 is formed in the plate member, extending in a direction intersecting the longitudinal direction of the shaft portion 10. The recess 29 increases the bending rigidity of the plate member, resulting in a rectangular thin plate 20 that can also be deformed into a cylindrical shape. That is, by warping the thin plate 20 in a direction that eliminates the recess 29, the bending rigidity is relatively reduced, and the thin plate 20 can return to the generally cylindrical shape shown in FIGS. 2(B) and 3.

[0029] The length L20 of the thin plate 20 in the X-axis direction (hereinafter also referred to as the "length L20 of the thin plate 20") and the length W20 of the thin plate 20 in the Z-axis direction (hereinafter also referred to as the "width W20 of the thin plate 20") shown in FIG. 1 can be determined arbitrarily. The support device 1 not only provides a backup force to the medical device, but may also be pushed through a blood vessel by following the medical device. Therefore, the length L20 of the thin plate 20 is preferably set to, for example, 50 mm or more. Furthermore, since the support device 1 is attached to a medical device that has been removed from the body, the length L20 of the thin plate 20 is preferably set to, for example, 150 mm or less. Furthermore, in order to form a cylinder using the thin plate 20, the width W20 of the thin plate 20 is preferably set to, for example, 1.25 times or more the circumferential length of the medical device. Furthermore, in order to configure the cylindrical thin plate 20 flexibly, the width W20 of the thin plate 20 is preferably set to, for example, 1.75 times or less the circumferential length of the medical device.

[0030] 1, the thin plate 20 has a length L20 in the X-axis direction that is longer than a length W20 in the Z-axis direction. In this case, as shown in FIG. 1, the shaft portion 10 is fixed to an end portion of the thin plate 20 in the longitudinal direction (X-axis direction) and also to a center portion of the thin plate 20 in the lateral direction (Z-axis direction). In other words, the linear distance from the end portion 201 to the axis O passing through the center of the shaft portion 10 is approximately half (W20 / 2) of the length W20 in the Z-axis direction.

[0031] 4 is a diagram showing the insertion of a balloon catheter 3 into a coronary artery 91. FIG. 4 illustrates the coronary artery 91 extending from an aorta 90, and a first branch 92 and a second branch 93 of the coronary artery 91. A stenotic portion 99 in which the lumen of the blood vessel is narrowed is formed at the distal portion of the second branch 93. Hereinafter, a method of applying a backup force to the balloon catheter 3 using a support device 1 after the procedure (PCI) for dilating the stenotic portion 99 using the balloon catheter 3 will be described.

[0032] First, the surgeon inserts the guiding catheter 4 from the aorta 90 to the entrance of the coronary artery 91. The surgeon projects the guidewire 2 from the tip of the guiding catheter 4 into the first branch 92 and advances the guidewire 2 from the first branch 92 to the distal portion of the second branch 93. Next, the surgeon advances the balloon catheter 3, with the guidewire 2 housed inside, along the guidewire 2 from the first branch 92 to the second branch 93. Here, depending on the shape of the bifurcation B between the first branch 92 and the second branch 93, the diameters of the first branch 92 and the second branch 93, the tip of the balloon catheter 3 may get stuck near the bifurcation B, making it impossible to deliver the tip of the balloon catheter 3 to the stenosis 99 ( FIG. 4 ).

[0033] 5A and 5B are diagrams showing the state in which the support device 1 is attached to the balloon catheter 3. FIG. 5A shows the state in which the balloon catheter 3 is placed on the thin plate 20, and FIG. 5B shows the state in which the thin plate 20 has been deformed into a substantially cylindrical shape. Note that FIG. 5 shows a portion of the proximal end of the guidewire 2 and balloon catheter 3 that are positioned outside the patient's body, and a portion of the distal end of the support device 1. As described in FIG. 4, when the balloon catheter 3 becomes stuck at the bifurcation B of the coronary artery 91, the surgeon attaches the support device 1 to the balloon catheter 3.

[0034] Specifically, as shown in FIG. 5(A), the surgeon grasps the guidewire 2 and balloon catheter 3 outside the patient's body and places them together on the first main surface 21 of the thin plate 20 of the support device 1. While grasping the thin plate 20, the surgeon presses the recessed portion 29 from the second main surface 22 side, bending the thin plate 20 in a direction that eliminates the recess of the recessed portion 29 (the direction of the hatched arrow in FIG. 5(A)). This causes the thin plate 20 to deform into a substantially cylindrical shape, as shown in FIG. 5(B). At this time, the guidewire 2 and balloon catheter 3 that were placed on the first main surface 21 are housed in the device lumen 20L formed inside the cylindrical thin plate 20. In this state, the surgeon can deliver the support device 1 with the guidewire 2 and balloon catheter 3 housed inside the cylindrical thin plate 20 by pushing the shaft portion 10 of the support device 1 toward the distal end.

[0035] FIG. 6 is a diagram illustrating the application of backup force by the support device 1. Similar to FIG. 4, FIG. 6 illustrates an aorta 90, a coronary artery 91, a first branch 92, a second branch 93, and a stenosis 99. After attaching the support device 1 to the balloon catheter 3 using the method described in FIG. 5, the surgeon delivers the support device 1 inside the guiding catheter 4 by pushing the shaft portion 10 of the support device 1 toward the distal end. The surgeon then protrudes the distal end of the thin plate 20 of the support device 1 from the distal end of the guiding catheter 4 into the first branch 92, placing it near the bifurcation B between the first branch 92 and the second branch 93. In this state, the surgeon pushes the stuck balloon catheter 3 toward the second branch 93. Here, the balloon catheter 3 is supported by the cylindrical thin plate 20, allowing the balloon catheter 3 to move from the bifurcation B toward the second branch 93 (FIG. 6).

[0036] The surgeon may rotate the shaft portion 10 of the support device 1 to rotate the cylindrical thin plate 20 and thereby unstuck the balloon catheter 3. If the cylindrical thin plate 20 becomes stuck in the first branch 92 or the second branch 93, the surgeon may unstuck the cylindrical thin plate 20 by rotating the shaft portion 10 of the support device 1 in the opposite direction. Furthermore, the surgeon may push the cylindrical thin plate 20 along with the balloon catheter 3 to the vicinity of the stricture 99 of the second branch 93. By pushing the cylindrical thin plate 20 to the vicinity of the stricture 99, the cylindrical thin plate 20 can be used to support a portion of the balloon catheter 3 with relatively low rigidity. Even when the balloon catheter 3 is removed and another medical device is inserted, the cylindrical thin plate 20 and the guiding catheter 4 ensure a clear path to the stricture 99. This improves the efficiency of the procedure. The support device 1 may be used endoscopically.

[0037] Here, in support device 1 of this embodiment, end 201 and end 202 of cylindrical thin plate 20 overlap each other. Therefore, in support device 1 of this embodiment, the tip of support device 1 (tip of thin plate 20) is located at bifurcation B of aorta 90, and even if balloon catheter 3 is greatly curved, it is possible to prevent balloon catheter 3 from coming off support device 1 (cylindrical thin plate 20).

[0038] As described above, the support device 1 of the first embodiment includes the thin plate 20 disposed at the distal end of the shaft portion 10. The thin plate 20 is made of an elastic metal and has a recessed portion 29 extending in a direction intersecting the longitudinal direction of the shaft portion 10. The thin plate 20 is deformed into a substantially cylindrical shape by warping the thin plate 20 in a direction that eliminates the recessed portion 29 ( FIG. 3 ). Therefore, even if a medical device such as a balloon catheter 3 has already been inserted into a biological lumen, the medical device can be placed on one of the main surfaces (first main surface 21) of the thin plate 20, and the recessed portion of the thin plate 20 is eliminated to deform the thin plate 20 into a substantially cylindrical shape. The medical device can then be accommodated inside the cylindrical thin plate 20 (device lumen 20L). As a result, the cylindrical thin plate 20 can support the medical device and provide backup force to the medical device. Furthermore, unlike conventional guide extension catheters, the cylindrical thin plate 20 does not have an exchange channel that connects the inside and outside of the cylinder (tube body) (FIGS. 2(B) and 3). Therefore, even if the cylindrical thin plate 20 is bent at a blood vessel bifurcation B or the like, there is no risk of the medical device flying out of the exchange channel (in other words, the medical device becoming detached from the support device 1). As a result, according to the support device 1 of the first embodiment, the support device 1 can apply a backup force to a medical device inserted into a biological lumen without removing the medical device, and it is possible to prevent the medical device housed inside from becoming detached.

[0039] Furthermore, according to the support device 1 of the first embodiment, when the thin plate 20 is deformed into a substantially cylindrical shape, the axis O20 is aligned with the longitudinal direction of the shaft portion 10 that is gripped and operated by the surgeon (FIG. 3). This improves the torque transmission performance of the support device 1 and improves usability.

[0040] Furthermore, according to the support device 1 of the first embodiment, the shaft portion 10 is fixed to the end portion of the thin plate 20 in the longitudinal direction (X-axis direction in FIG. 1), which prevents the shaft portion 10 from interfering with the surgeon's operation to eliminate the depression. Also, the shaft portion 10 is fixed to the center portion of the thin plate 20 in the lateral direction (Z-axis direction in FIG. 1). Therefore, as shown in FIG. 5(A), the surgeon can grasp the medical device such as the balloon catheter 3 and the shaft portion 10 together, which improves the usability of the support device 1.

[0041] Furthermore, according to the support device 1 of the first embodiment, the shaft portion 10 includes a flat connecting portion 12 provided at the tip of the main body portion 11, and therefore the joining area between the thin plate 20 and the main body portion 11 can be increased by joining the thin plate 20 and the main body portion 11 at the connecting portion 12. Therefore, the joining strength between the thin plate 20 and the main body portion 11 can be improved compared to when the thin plate 20 and the main body portion 11 are simply joined.

[0042] Second Embodiment FIG. 7 is an explanatory diagram illustrating the configuration of a support device 1A of a second embodiment. FIG. 8 is an explanatory diagram illustrating the configuration of a thin plate 20A as viewed from direction A (FIG. 1). The support device 1A of the second embodiment includes a thin plate 20A instead of the thin plate 20 in the configuration of the first embodiment. As shown in FIGS. 7 and 8, a plurality of grooves 25 are formed on the second main surface 22 of the thin plate 20A. Each groove 25 is a linear recess extending from end 201 to end 202 in a direction (Z-axis direction) intersecting the longitudinal direction (X-axis direction) of the shaft portion 10. The grooves 25 are equally spaced apart at intervals S25 in the longitudinal direction of the shaft portion 10. In the illustrated example, each groove 25 intersects perpendicularly with the longitudinal direction of the shaft portion 10. However, the grooves 25 do not have to be perpendicular as long as they intersect with the longitudinal direction of the shaft portion 10.

[0043] As described above, the configuration of the thin plate 20A can be modified in various ways, and grooves 25 may be formed on the second main surface 22. In the example of FIG. 7, multiple grooves 25 are formed on the second main surface 22, but the grooves 25 may be formed only on the first main surface 21, or on both the first main surface 21 and the second main surface 22. The number of grooves 25 may be one or more. When multiple grooves 25 are formed, the grooves 25 do not have to be equally spaced. Furthermore, the shape of the grooves 25 does not have to be linear, and can be any shape, such as wavy or U-shaped. The support device 1A of this second embodiment can also achieve the same effects as the first embodiment described above.

[0044] Furthermore, according to the support device 1A of the second embodiment, grooves 25 extending in a direction intersecting the longitudinal direction of the shaft portion 10 are formed on at least one of the main surfaces 21, 22 of the thin plate 20A. Therefore, as shown in FIG. 7, after the thin plate 20A is deformed into a substantially cylindrical shape, at least one of the outer peripheral surface 22 and the inner peripheral surface 21 of the cylindrical thin plate 20A has grooves 25 extending in the circumferential direction. Therefore, when the cylindrical thin plate 20A bends at a blood vessel bifurcation B or the like, the grooves 25 can be easily used as a starting point for bending. Furthermore, if a plurality of grooves 25 are formed in the thin plate 20A as shown in FIG. 7, the cylindrical thin plate 20A can be formed into a bellows-like shape, making it even easier to bend.

[0045] <Third embodiment> FIG. 9 is an explanatory diagram illustrating the configuration of a support device 1B of the third embodiment. The support device 1B of the third embodiment includes a thin plate 20B instead of the thin plate 20 in the configuration of the first embodiment. The thin plate 20B is a rectangular plate member with four rounded corners (in other words, four corners). As described above, the configuration of the thin plate 20B can be modified in various ways, and the corners may be rounded. The support device 1B of the third embodiment can also achieve the same effects as the first embodiment described above. Furthermore, according to the support device 1B of the third embodiment, the corners of the thin plate 20B are rounded, which reduces the risk of the corners of the thin plate 20B getting caught on a biological lumen or a medical device. This improves the safety of the support device 1B and suppresses damage to a medical device used in combination.

[0046] <Fourth embodiment> FIG. 10 is an explanatory diagram illustrating the configuration of a support device 1C of a fourth embodiment. The support device 1C of the fourth embodiment has a shaft portion 10C instead of the shaft portion 10 in the configuration of the first embodiment. Of the shaft portion 10C, the connection portion 12C is an end portion in the longitudinal direction (X-axis direction) of the thin plate 20, and is fixed at an arbitrary position closer to the end portion 201 than the center portion in the lateral direction (Z-axis direction) of the thin plate 20. As described above, the configuration of the shaft portion 10C can be modified in various ways, and the shaft portion 10C does not have to be fixed to the center portion in the lateral direction of the thin plate 20. The support device 1C of the fourth embodiment can also achieve the same effects as the first embodiment described above.

[0047] Fifth Embodiment FIG. 11 is an explanatory diagram illustrating the configuration of a support device 1D according to a fifth embodiment. The support device 1D according to the fifth embodiment includes a shaft portion 10D instead of the shaft portion 10 in the configuration of the first embodiment. The shaft portion 10D includes a main body portion 11D and a grip portion 30 instead of the main body portion 11 and the connecting portion 12 described in the first embodiment. As shown in FIG. 11, the main body portion 11D is a hollow, approximately cylindrical member extending along the longitudinal direction (X-axis direction) and having a substantially constant outer diameter from the tip to the base end. The curved portion 32 of the grip portion 30 is inserted and fixed to the tip of the main body portion 11D. The main body portion 11D and the grip portion 30 can be fixed to each other by metallurgical joining such as fusion welding, pressure welding, or brazing, or by adhesive joining using any adhesive. The main body portion 11D may also have a solid, approximately cylindrical shape. In this case, the curved portion 32 of the grip portion 30 may be joined to the outer circumferential surface of the main body portion 11D.

[0048] FIG. 12 is an explanatory diagram illustrating the configuration of the gripping portion 30. FIG. 12 illustrates the configuration of the gripping portion 30 as viewed from direction A in FIG. 11. The gripping portion 30 is a member provided at the tip of the main body portion 11D between the main body portion 11D and the thin plate 20. As shown in FIG. 12, the gripping portion 30 has a gripping body 31 and a curved portion 32. The gripping body 31 is a pair of plate-shaped portions extending along the longitudinal direction (X-axis direction) of the support device 1D. The gripping bodies 31 are each biased toward the gap 30a (the direction of the white arrow). The curved portion 32 connects one gripping body 31 to another gripping body 31 and is a curved portion. The gripping portion 30 grips the thin plate 20 inserted into the gap 30a. Specifically, the thin plate 20 is gripped by sandwiching it from both main surfaces 21 and 22 of the thin plate 20. With the gripping unit 30 gripping the thin plate 20, the two may be fixed to each other by metallurgical joining such as fusion welding, pressure welding, or brazing, or by adhesive joining using any adhesive. The lengths of the gripping unit 30 in the X-axis and Z-axis directions can be determined arbitrarily.

[0049] The gripping portion 30 is preferably antithrombogenic, flexible, and biocompatible, and can be formed from, for example, stainless steel alloys such as SUS302, SUS304, and SUS316; superelastic alloys such as NiTi alloys; radiolucent alloys such as piano wire, nickel-chromium alloys, and cobalt alloys; or radiopaque alloys such as gold, platinum, tungsten, and alloys containing these elements (e.g., platinum-nickel alloys).

[0050] As described above, the configuration of the shaft portion 10D can be modified in various ways, and the shaft portion 10D may have a gripping portion 30. The support device 1D of the fifth embodiment can also achieve the same effects as the first embodiment described above. Furthermore, according to the support device 1D of the fifth embodiment, the shaft portion 10D has a gripping portion 30 that is provided at the tip of the main body portion 11D and that grips the thin plate 20 by sandwiching the thin plate 20 from the main surfaces 21 and 22 on both sides of the thin plate 20 (FIGS. 11 and 12). Therefore, compared to simply joining the thin plate 20 and the main body portion 11D, the thin plate 20 and the main body portion 11D can be reliably fixed with a simple structure.

[0051] <Modification of this embodiment> The present invention is not limited to the above-described embodiment, and can be embodied in various forms without departing from the spirit of the invention. For example, the following modifications are also possible.

[0052] [Variation 1] In the first to fifth embodiments described above, the configurations of the support devices 1, 1A to 1D have been exemplified. However, the configuration of the support device 1 can be modified in various ways. For example, the main body 11 and the gripping portion 30 may be integrally formed. For example, a radiopaque marker may be provided at the distal end of the support device 1 (the distal end of the thin plate 20). For example, a connector may be provided at the proximal end of the support device 1 (the proximal end of the shaft 10) to allow the surgeon to grip the support device 1. For example, the surfaces of at least some of the members of the shaft 10 and the thin plate 20 may be coated with a hydrophilic or hydrophobic resin.

[0053] [Variation 2] The configurations of the support devices 1, 1A to 1D of the first to fifth embodiments and the configurations of the modified example 1 may be combined as appropriate. For example, a thin plate 20 having the groove portion 25 described in the second embodiment and the shape described in the third embodiment may be configured. For example, a support device 1 may be configured by combining the thin plate 20 described in the first to third embodiments with the shaft portion 10, 10D described in the fourth or fifth embodiment.

[0054] This aspect has been described above based on embodiments and modifications. However, the above-described embodiments are intended to facilitate understanding of this aspect and are not intended to limit this aspect. This aspect may be modified or improved without departing from the spirit and scope of the claims, and equivalents thereof are included in this aspect. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate. [Explanation of symbols]

[0055] 1, 1A~1D...Supported devices 2...Guidewire 3...Balloon catheter 4...Guiding catheter 10, 10C, 10D...shaft section 11...Main body 12,12C...Connection 20,20A,20B…thin plate 21...First main surface 22...Second main surface 25...Groove 29...Recess 30...Gripping part 31...Gripper 32...Bend 90...Aorta 91...Coronary artery 92…1st branch 93…Second branch 99...Stenosis 201...End 202...End

Claims

1. A support device for supporting a medical device that is inserted into a biological lumen for use, a shaft portion having an elongated outer shape; a thin plate disposed at a tip end of the shaft portion; Equipped with The thin plate is The shaft portion is formed of an elastic metal preformed into a substantially cylindrical shape, and the plate shape is maintained by a recess extending in a direction intersecting the longitudinal direction of the shaft portion. A support device in which the thin plate is warped in a direction that eliminates the depression, thereby transforming from the plate shape to the approximately cylindrical shape and accommodating the medical device inside the thin plate.

2. 10. The support device of claim 1, A support device, wherein the axis of the thin plate when deformed into the approximately cylindrical shape is aligned with the longitudinal direction of the shaft portion.

3. 3. The support device of claim 2, The thin plate in the plate form has a rectangular shape, A support device in which the shaft portion is an end portion of the thin plate in the longitudinal direction and is fixed to the center portion of the thin plate in the lateral direction.

4. A support device according to any one of claims 1 to 3, The thin plate has a pair of main surfaces, A support device, wherein a groove portion extending in a direction intersecting the longitudinal direction of the shaft portion is formed on at least one of the main surfaces of the thin plate.

5. A support device according to any one of claims 1 to 4, The thin plate has a pair of main surfaces, The shaft portion a main body; a gripping portion provided at a tip end of the main body portion and configured to grip the thin plate, the gripping portion sandwiching the thin plate from the main surfaces on both sides of the thin plate to grip the thin plate; A support device comprising:

6. A support device according to any one of claims 1 to 4, The thin plate has a pair of main surfaces, The shaft portion includes a main body portion and a flat connecting portion provided at a tip end of the main body portion, A support device, wherein the connection portion is fixed to one of the main surfaces of the thin plate.

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