JP7742732B2 - Supported Devices - Google Patents

Description

The present invention relates to a support device for supporting a medical device.

A procedure known as "PCI (percutaneous transluminal coronary intervention)" is used to dilate stenotic or occlusive lesions in the coronary arteries of the heart from the inside of the blood vessel. In PCI, for example, a balloon catheter equipped with an expandable balloon is used to dilate the stenotic area and ensure blood flow. During this procedure, the balloon may become stuck at the vascular bifurcation due to insufficient backup force of the balloon catheter, preventing it from reaching the stenotic area. For example, Patent Documents 1 and 2 disclose guide extension catheters that can supplement the backup force of a balloon catheter by housing it internally. Patent Document 3 also discloses a secondary catheter that is inserted inside a catheter. Patent Document 4 discloses a wire guide that can be attached to the proximal end of a guide wire inserted inside the body to extend the guide wire.

Special table 2015-524737 publication Special table 2018-531660 publication Japanese Patent Application Laid-Open No. 2015-173914 Special Publication No. 2009-525134

The proximal end of a balloon catheter is typically provided with a large-diameter connector for the surgeon to grasp or insert a drug or concomitant device. Therefore, using the guide extension catheters described in Patent Documents 1 and 2, applying backup force to a balloon catheter that has been inserted into the body and delivered to the vicinity of the stenosis site requires removing the balloon catheter from the body, which is time-consuming and labor-intensive. Similarly, applying backup force to the secondary catheter described in Patent Document 3 requires removing the balloon catheter from the body, which is time-consuming and labor-intensive. Furthermore, the wire guide described in Patent Document 4 does not take into consideration the application of backup force to the balloon catheter.

This issue is not limited to PCI using balloon catheters, but is a common issue when it is necessary to provide backup power to medical devices inserted into biological lumens, such as the vascular system, lymphatic system, biliary system, urinary tract system, respiratory system, digestive system, secretory glands, and reproductive organs.

The present invention has been made to solve at least some of the above-mentioned problems, and aims to provide a support device that can apply backup force to a medical device inserted into a biological lumen without removing the medical device.

The present invention has been made to solve at least some of the above-mentioned problems, and can be realized in the following forms.

(1) One aspect of the present invention provides a support device for supporting a medical device. This support device includes a shaft portion having an elongated outer shape, a coil body having an elongated outer shape provided at the tip of the shaft portion, and a covering portion covering at least a portion of the outer surface of the coil body in the longitudinal direction. The covering portion has a distal opening at the tip and a proximal opening at the base end, and a slit is provided on the side of the covering portion that connects the distal opening and the proximal opening and communicates the inside and outside of the covering portion, extending along the gap of the coil body.

With this configuration, the support device includes a coil body with an elongated outer shape. Therefore, by housing a medical device such as a balloon catheter inside the coil body (inner cavity), the coil body can support the medical device and provide backup force to the medical device. Furthermore, at least a portion of the longitudinal section of the coil body is covered with a covering portion, and a slit is provided on the side of the covering portion, connecting the distal opening and the proximal opening and communicating the inside and outside of the covering portion, extending along the gap in the coil body. Therefore, even if the medical device is already inserted into a biological lumen, the medical device can be housed inside the coil body via the gap and slit in the coil body. In other words, with this configuration, a support device can be provided that can provide backup force to a medical device inserted into a biological lumen without removing it. As a result, the effort and time required for the procedure can be reduced, and the procedure can be made more efficient. Furthermore, in the section where the covering portion is provided, the narrow slit prevents the medical device from falling out of the gap in the coil body.

(2) In the support device of the above embodiment, the coil body may be formed by winding a flat plate-shaped member, the covering portion may include a base-end covering portion that covers the base end of the coil body, the base-end covering portion may cover the inner circumferential surface of the coil body in addition to the outer circumferential surface of the coil body, and the portion covering the outer circumferential surface and the portion covering the inner circumferential surface may be connected at the base end of the coil body.
According to this configuration, the proximal covering portion that covers the proximal end of the coil body covers both the outer circumferential surface and the inner circumferential surface of the coil body, and the portion covering the outer circumferential surface and the portion covering the inner circumferential surface are connected at the proximal end of the coil body. That is, the proximal end of the coil body is covered by the proximal covering portion. Therefore, when a medical device such as a balloon catheter is inserted into the inside (lumen) of the coil body from the proximal end side of the coil body, damage to the medical device due to contact between the proximal end of the coil body and the medical device can be suppressed compared to a configuration in which the proximal end of the coil body is exposed.

(3) In the support device of the above aspect, the covering portion may include a distal covering portion that covers the distal end of the coil body, and the distal end of the distal covering portion may be located distal to the distal end of the coil body.
According to this configuration, the tip of the tip side covering portion is located more distal than the tip of the coil. That is, the tip side of the tip side covering portion includes a section that does not contain the coil. This allows the tip side of the tip side covering portion to be configured more flexibly, thereby improving the safety of the support device.

(4) In the support device of the above embodiment, the covering portion may include a distal covering portion that covers the distal end of the coil body, and a distal tip may be fixed to the distal end of the distal covering portion. The distal tip may be a cylindrically curved plate member with both circumferential ends of the plate member overlapping each other, and a medical device may be inserted into and removed from the distal tip by expanding the gap between the both ends.
According to this configuration, the distal tip is fixed to the distal end of the distal covering part, allowing the distal end of the distal covering part to be configured more flexibly, thereby improving the safety of the support device. Furthermore, the distal tip is a cylindrically curved plate member, and both circumferential ends of the plate member overlap each other, further preventing the medical device inserted inside (inner cavity) from becoming dislodged. Furthermore, by expanding the gaps at both ends of the plate member, the medical device can be easily inserted and removed from the distal tip.

(5) In the support device of the above aspect, the distal end of the slit of the distal covering portion and the base end of one of the two end portions of the distal tip may be at the same position in the circumferential direction.
With this configuration, the tip of the slit in the tip-side covering portion and the base end of one of the two ends of the tip tip are at the same circumferential position, making it easier and quicker to insert and remove a medical device into and from the tip tip.

(6) In the support device of the above form, the shaft portion may include a main body portion extending along the longitudinal direction, and a gripping portion provided at the tip of the main body portion for gripping the coil body, the gripping portion sandwiching the coil body from both the outer peripheral surface side and the inner peripheral surface side of the coil body to grip the coil body.
According to this configuration, the shaft portion includes gripping portions that sandwich and grip the coil body from both the outer and inner peripheral sides of the coil body, which allows the coil body and the main body portion to be reliably fixed together with a simpler structure than when the coil body and the main body portion are simply joined together.

The present invention can be realized in various forms, such as a support device for supporting a medical device, a shaft portion or coil body for a support device, a catheter system equipped with a support device, and a method for manufacturing a support device.

FIG. 2 is an explanatory diagram illustrating the configuration of a support device according to the first embodiment. 2 is a cross-sectional view of the support device taken along line AA (FIG. 1). FIG. 1 is a diagram showing a state in which a balloon catheter is inserted into a coronary artery. 10A and 10B show attachment of a support device to a balloon catheter. 10A and 10B are diagrams illustrating the application of a backup force by a support device. 10A and 10B are diagrams illustrating an example of the effect of the tip side covering portion. 10A and 10B are diagrams illustrating an example of the effect of a base-end covering portion. FIG. 10 is an enlarged view of the tip side of the support device according to the second embodiment. 10 is an explanatory diagram illustrating the configuration of a distal tip of a support device according to a third embodiment. FIG. 10 is an explanatory diagram illustrating the configuration of a distal tip of a support device according to a third embodiment. FIG. FIG. 13 is an explanatory diagram illustrating the configuration of a support device according to a fourth embodiment. FIG. 13 is an explanatory diagram illustrating the configuration of a support device according to a fifth embodiment. FIG. 20 is an explanatory diagram illustrating the configuration of a support device according to a sixth embodiment. FIG. 10 is a cross-sectional view of the support device of the seventh embodiment taken along line AA (FIG. 1). FIG. 20 is an explanatory diagram illustrating the configuration of a support device according to the eighth embodiment. FIG. 20 is an explanatory diagram illustrating the configuration of a support device according to a ninth embodiment. 10A and 10B are explanatory diagrams illustrating the configuration of a gripping portion. 19A and 19B are explanatory diagrams illustrating the configuration of a gripping portion of a tenth embodiment.

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 also referred to as "PCI (percutaneous transluminal coronary intervention)"). Note that PCI is merely one example, and the support device 1 can be used in general when it is desired to provide a backup force later to a medical device that is inserted into a body lumen and used, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs.

As shown in FIG. 1, the support device 1 comprises a shaft portion 10, a coil body 20, a distal covering portion 40, and a proximal covering portion 50. The distal covering portion 40 and the proximal covering portion 50 are collectively referred to as "covering portions 40, 50." In FIG. 1, the axis passing through the center of the shaft portion 10 is represented by axis O1, and the axis passing through the center of the coil body 20 is represented by axis O2. As shown in FIG. 1, axis O1 and axis O2 do not intersect but extend parallel to each other. In addition, in FIG. 1, the portions of the coil body 20 covered by the distal covering portion 40 and the proximal covering portion 50 are shown with dashed lines.

Figure 1 illustrates mutually orthogonal X, Y, and Z axes. 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 Figure 1 (-X axis direction) is referred to as the "distal side" of the support device 1 and each component, and the right side of Figure 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 manipulated by an operator such as a doctor. These points are also common to Figure 1 and subsequent figures.

The shaft portion 10 is a long, cylindrical member located at the base end of the support device 1. The shaft portion 10 is a solid, generally cylindrical member with a substantially constant outer diameter from the tip to the base end. The entire shaft portion 10, or at least a portion thereof, may have a tapered diameter section in which the outer diameter tapers from the base end to the tip. The proximal end of the shaft portion 10 is grasped and manipulated by the surgeon. The distal end of the shaft portion 10 is fixed to the proximal end of the coil body 20. In the illustrated example, the shaft portion 10 is fixed to the outer circumferential surface of the coil body 20; however, the shaft portion 10 may also be fixed to the inner circumferential surface of the coil body 20. The shaft portion 10 and the coil body 20 can be fixed together using metallurgical bonding such as fusion welding, pressure welding, or brazing, or adhesive bonding using any adhesive. The distal end of the shaft portion 10 may be flattened (e.g., by pressing) to increase the bonding area with the coil body 20. The outer diameter and length of the shaft portion 10 can be determined as desired.

As shown in FIG. 1, the coil body 20 is provided at the tip of the shaft portion 10 and has a long outer shape. In this embodiment, the coil body 20 is a multi-strand coil formed by winding multiple strands of wires 21. In other words, the coil body 20 is formed by winding multiple strands of wires 21 bundled together in a flat plate shape. The coil body 20 has a helical gap 22. This gap 22 is used to accommodate a medical device inserted into a biological lumen inside the coil body 20. Details will be described later. The inside of the coil body 20 also functions as a device lumen 20L for inserting the medical device.

Such a coil body 20 can be fabricated, for example, as follows. First, multiple bobbins, each having a wire 21 wound thereon, are arranged at a predetermined interval around the circumferential direction of a long metal core, at positions spaced a predetermined distance radially outward from the metal core. Next, the multiple bobbins are rotated around the circumferential direction of the metal core while the metal core is moved axially, thereby winding the wire 21 drawn from each of the multiple bobbins onto the metal core. In this process, for example, the rotational speed of the multiple bobbins may be changed in two stages every predetermined period to fabricate a coil body 20 having a spiral gap 22. Instead of changing the rotational speed of the multiple bobbins, the moving speed of the metal core may be changed in two stages every predetermined period. Alternatively, for example, the spiral gap 22 may be formed by leaving some of the multiple bobbins empty (i.e., no wire 21 is set in the bobbins). The wound wire 21 may be joined to each other by, for example, laser welding to maintain the shape and improve torque transmission. The outer diameter, inner diameter, and length of the coil body 20, and the winding direction of the wire 21 can be determined arbitrarily.

Figure 2 is a cross-sectional view of the support device 1 taken along line A-A (Figure 1). Note that in Figure 2, dashed lines indicate circles passing through the centers of the wires 21 of the coil body 20. As shown in Figure 1, the distal covering portion 40 is a member that covers the distal end of the coil body 20, including the distal end 28 of the coil body 20. The distal covering portion 40 has a generally cylindrical (tubular) shape with a distal opening 40a at its distal end and a proximal opening 40b at its proximal end, and as shown in Figure 2, it covers the outer surface of the coil body 20. A slit 41 is provided on the side of the distal covering portion 40, connecting the distal opening 40a and the proximal opening 40b and providing communication between the inside and outside of the distal covering portion 40. As shown in Figure 1, the slit 41 extends spirally along the gap 22 of the coil body 20. The opening length L41 of the slit 41 shown in Figure 2 can be determined as desired. Hereinafter, the opening length L41 of the slit 41 will also be referred to as the "width of the slit 41." From the perspective of preventing the medical device inserted into the coil body 20 from becoming dislodged, the opening length L41 of the slit 41 may be smaller than the outer diameter of the medical device.

The tip of the distal covering portion 40 is located distal to the tip 28 of the coil body 20. Therefore, the distal side of the distal covering portion 40 includes a section 42 that does not contain the coil body 20. The shape of the slit 41 in the section 42 of the distal covering portion 40 that does not contain the coil body 20 need not be a spiral along the gap 22 of the coil body 20, but can be any shape. For example, the shape of the slit 41 in the section 42 may be a straight line along the longitudinal direction (X-axis direction) of the distal covering portion 40. The length L40 of the distal covering portion 40 in the longitudinal direction (X-axis direction) can be determined arbitrarily. From the perspective of device protection, the length L40 of the distal covering portion 40 may be equal to or greater than one pitch of the coil body 20. Furthermore, setting the length L40 of the distal covering portion 40 to equal to or greater than 5 to 6 pitches of the coil body 20 effectively prevents a medical device inserted through the coil body 20 from becoming dislodged.

The base-side covering portion 50 is a member that covers the base end portion of the coil body 20, including the base end 29 of the coil body 20. The base-side covering portion 50 has a generally cylindrical (tubular) shape with a tip-side opening 50a at its tip and a base-side opening 50b at its base, and covers the outer surface of the coil body 20. A slit 51 is provided on the side of the base-side covering portion 50, connecting the tip-side opening 50a and the base-side opening 50b and providing communication between the inside and outside of the base-side covering portion 50. As shown in Figure 1, the slit 51 extends spirally along the gap 22 of the coil body 20. The opening length of the slit 51 can be determined arbitrarily, similar to the opening length L41 of the slit 41 shown in Figure 2.

The base-side covering portion 50 also has an inner covering portion 52 that covers the inner circumferential surface of the coil body 20. The portion of the base-side covering portion 50 that covers the outer circumferential surface and the portion (inner covering portion 52) that covers the inner circumferential surface are connected at the base end 29 of the coil body 20. In other words, in the support device 1 of this embodiment, the base end 29 of the coil body 20 is covered by the base-side covering portion 50. The length L50 of the base-side covering portion 50 in the longitudinal direction (X-axis direction) can be determined arbitrarily. From the perspective of device protection, the length L50 of the base-side covering portion 50 may be equal to or greater than one pitch of the coil body 20. Furthermore, setting the length L50 of the base-side covering portion 50 to equal to or greater than 5 to 6 pitches of the coil body 20 can effectively prevent a medical device inserted through the coil body 20 from becoming dislodged. The length L50 of the base-side covering portion 50 and the length L40 of the distal-side covering portion 40 may be the same or different.

The shaft portion 10 is preferably antithrombogenic, flexible, and biocompatible, and can be formed, for example, from stainless steel alloys such as 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, polyolefin, polyester, polyurethane, silicone, fluorine, polyethylene, polycarbonate, and polypropylene. It is particularly preferable that the shaft portion 10 be formed from polycarbonate or polypropylene.

The wires 21 of the coil body 20 are preferably antithrombogenic, flexible, and biocompatible, and can be made from, for example, stainless steel alloys such as 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 distal covering portion 40 and the proximal covering portion 50 are preferably flexible and can be made of resin materials such as polyamide, polyolefin, polyester, polyurethane, silicone, fluorine, polyethylene, polycarbonate, and polypropylene. The distal covering portion 40 and the proximal covering portion 50 are particularly preferably made of polyamide or polyurethane. The shaft portion 10, coil body 20, distal covering portion 40, and proximal covering portion 50 may also be made of known materials other than those mentioned above.

Figure 3 shows the insertion of a balloon catheter 3 into a coronary artery 91. Figure 3 illustrates the coronary artery 91 extending from the aorta 90, and a first branch 92 and a second branch 93 of the coronary artery 91. A stenosis 99, where the lumen of the blood vessel is narrowed, has formed at the distal portion of the second branch 93. Below, we will explain a method for applying backup force to the balloon catheter 3 using a support device 1 after the procedure (PCI) to dilate the stenosis 99 using the balloon catheter 3.

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 and the thickness of the first branch 92 and the second branch 93, the tip of the balloon catheter 3 may become stuck near the bifurcation B, preventing the tip of the balloon catheter 3 from being delivered to the stenosis 99 (Figure 3).

Figure 4 shows the attachment of the support device 1 to the balloon catheter 3. Figure 4 illustrates the proximal portions of the guidewire 2 and balloon catheter 3 positioned outside the patient's body, and the distal portion of the coil body 20 of the support device 1. Also, in Figure 4, only the outline of the coil body 20, which is covered by the distal covering portion 40, is shown with a dashed line. As explained in Figure 3, 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.

Specifically, as shown in the upper part of Figure 4, the surgeon grasps the guidewire 2 and balloon catheter 3 outside the patient's body and bundles them together, then inserts them into the gap 22 of the coil body 20 of the support device 1. In this state, the surgeon rotates the distal end of the coil body 20 (the area enclosed by the dashed line in the upper part of Figure 4) so as to wrap it around the guidewire 2 and balloon catheter 3. This causes portions of the guidewire 2 and balloon catheter 3 to be housed inside the coil body 20 (device lumen 20L) via the spiral gap 22 of the coil body 20 and the spiral slit 41 of the distal covering portion 40. At this time, the surgeon rotates the coil body 20 at least two times to house portions of the guidewire 2 and balloon catheter 3 at least two pitches inside the coil body 20. This allows the axis O2 of the coil body 20 to be parallel to the axial direction of the guidewire 2 and balloon catheter 3.

Next, the surgeon rotates the coil body 20 so that the guidewire 2 and a portion of the balloon catheter 3 are housed inside the coil body 20 and the distal covering portion 40. At this time, in the section where the distal covering portion 40 is provided, the guidewire 2 and the balloon catheter 3 are inserted into the interior of the distal covering portion 40 through the slit 41 in the distal covering portion 40. Next, the surgeon rotates the coil body 20 in the opposite direction so that the entire guidewire 2 and the balloon catheter 3 are housed inside the coil body 20 and the proximal covering portion 50. At this time, in the section where the proximal covering portion 50 is provided, the guidewire 2 and the balloon catheter 3 are inserted into the interior of the proximal covering portion 50 through the slit 51 in the proximal covering portion 50. Then, the surgeon slides the coil body 20 of the support device 1 toward the distal end, as shown in the lower part of Figure 4. As a result, the guidewire 2 and the balloon catheter 3 are entirely housed inside the coil body 20 (device lumen 20L). In this state, the surgeon can deliver the support device 1 by pushing the shaft portion 10 of the support device 1 toward the distal end, with the guide wire 2 and balloon catheter 3 housed inside the coil body 20.

Figure 5 illustrates the application of backup force by the support device 1. Similar to Figure 3, Figure 5 illustrates the aorta 90, coronary artery 91, first branch 92, second branch 93, and stenosis 99. After attaching the support device 1 to the balloon catheter 3 using the method described in Figure 4, 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 coil body 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. Because the balloon catheter 3 is supported by the coil body 20 and distal covering portion 40 of the support device 1, the balloon catheter 3 can advance from the bifurcation B toward the second branch 93 (Figure 5).

The surgeon may rotate the shaft 10 of the support device 1 to rotate the coil body 20 and unstuck the balloon catheter 3. If the coil body 20 becomes stuck in the first branch 92 or the second branch 93, the surgeon may unstuck the coil body 20 by rotating the shaft 10 of the support device 1 in the opposite direction. Furthermore, the surgeon may push the coil body 20 of the support device 1 along with the balloon catheter 3 to the vicinity of the stenosis 99 of the second branch 93. By pushing the coil body 20 to the vicinity of the stenosis 99, the coil body 20 can be used to support the 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 coil body 20 ensures that a path to the stenosis 99 is secured. This improves the efficiency of the procedure. The support device 1 may also be used endoscopically.

Figure 6 is a diagram illustrating an example of the effect of the distal covering portion 40. In Figure 6, only the outline of the coil body 20 is shown by a dashed line for the portion of the coil body 20 covered by the distal covering portion 40. As shown in Figure 6, in the support device 1 of this embodiment, even when the distal end of the support device 1 is located at the bifurcation B of the aorta 90 and the balloon catheter 3 is in a significantly curved state, the distal covering portion 40 can prevent the balloon catheter 3 from becoming detached from the support device 1. Such detachment of the balloon catheter 3 is particularly likely to occur when the support device 1 is rotated to deliver it to the target branch or to release it from a stuck state.

7 is a diagram illustrating an example of the effect of the proximal covering portion 50. Note that in FIG. 7, only the outline of the coil body 20 is shown with a dashed line for the portion of the coil body 20 covered by the proximal covering portion 50. FIGS. 3 to 6 illustrate an example in which the support device 1 is used after inserting the balloon catheter 3 into the aorta 90. However, depending on the procedure, the balloon catheter 3 may be used after inserting the support device 1 into the aorta 90. In this case, as shown in FIG. 7, the surgeon inserts the balloon catheter 3 into the device lumen 20L from the proximal side of the coil body 20 of the support device 1 (in other words, from the proximal opening 50b of the proximal covering portion 50). In the support device 1 of this embodiment, the proximal end 29 of the coil body 20 is covered by the proximal covering portion 50. Therefore, damage to the balloon catheter 3 due to contact of the balloon 301 with the proximal end 29 of the coil body 20 can be reduced compared to a configuration in which the proximal end 29 of the coil body 20 is exposed.

As described above, the support device 1 of the first embodiment includes a coil body 20 having an elongated outer shape. Therefore, by accommodating a medical device such as a balloon catheter 3 inside the coil body 20 (device lumen 20L), the coil body 20 can support the medical device and provide backup force to the medical device. Furthermore, at least a portion of the longitudinal section of the coil body 20 is covered with covering portions 40, 50, and the side surfaces of the covering portions 40, 50 are provided with slits 41, 51 that connect the distal openings 40a, 50a and the proximal openings 40b, 50b and communicate the inside and outside of the covering portions 40, 50, extending along the gap 22 of the coil body 20. Therefore, even if the medical device has already been inserted into the aorta 90 (biological lumen), the medical device can be accommodated inside the coil body 20 via the gap 22 of the coil body 20 and the slits 41, 51. That is, the support device 1 of the first embodiment can provide a support device 1 that can apply a backup force to a medical device inserted into the aorta 90 without removing the medical device. As a result, the labor and time required for the procedure can be reduced, and the efficiency of the procedure can be improved. Furthermore, as shown in FIG. 6 , in the section where the covering portions 40, 50 are provided, the narrow slits 41 can prevent the medical device from coming off the gap 22 of the coil body 20.

Furthermore, according to the support device 1 of the first embodiment, the proximal covering portion 50 that covers the proximal end of the coil body 20 covers both the outer and inner circumferential surfaces of the coil body 20, and the portion covering the outer circumferential surface and the portion covering the inner circumferential surface (inner covering portion 52) are connected at the proximal end of the coil body 20. In other words, the proximal end 29 of the coil body 20 is covered by the proximal side of the proximal covering portion 50. Therefore, as shown in FIG. 7 , when a medical device such as a balloon catheter 3 is inserted from the proximal side of the coil body 20 into the inside of the coil body 20 (device lumen 20L), damage to the medical device due to contact between the proximal end 29 of the coil body 20 and the medical device can be reduced compared to a configuration in which the proximal end 29 of the coil body 20 is exposed.

Furthermore, according to the support device 1 of the first embodiment, the tip of the tip side covering portion 40 is located further distal than the tip 28 of the coil body 20. In other words, the tip side of the tip side covering portion 40 includes a section 42 that does not contain the coil body 20. Therefore, compared to a configuration that does not have the section 42 that does not contain the coil body 20, the tip side of the tip side covering portion 40 can be configured to be more flexible, thereby improving the safety of the support device 1.

Second Embodiment
Figure 8 is an enlarged view of the distal end of a support device 1A according to a second embodiment. The lower part of Figure 8 illustrates the configuration of the support device 1A, and the upper part (in the balloon) of Figure 8 illustrates the configuration of the distal tip 43. The support device 1A of the second embodiment includes a distal covering portion 40A instead of the distal covering portion 40 of the first embodiment, and also includes a distal tip 43. The distal covering portion 40A does not include the section 42 (the section not containing the coil body 20) described in the first embodiment, and has the same configuration as the first embodiment except that the distal tip 43 is fixed to the distal end. The distal covering portion 40 and the distal tip 43 can be fixed to each other by metallurgical joining such as fusion welding, pressure welding, or brazing, or by adhesive joining using any bonding agent.

As shown in the upper part of Figure 8 (in the speech bubble), the distal tip 43 is a cylindrically curved plate member whose circumferential ends 431 and 432 overlap each other (shown in a dashed circle). The surgeon can insert or remove a medical device through the gap 433 by pushing open the gap 433 between the ends 431 and 432 with a finger or a medical device such as a balloon catheter 3. The plate member constituting the distal tip 43 is biased so that the ends 431 and 432 overlap each other (shown in a black arrow). Therefore, the gap 433 expanded by the finger closes as the finger is removed. The distal tip 43 is preferably flexible and can be formed from a resin material such as polyamide, polyolefin, polyester, polyurethane, silicone, fluorine, polyethylene, polycarbonate, or polypropylene. The distal tip 43 is preferably formed from polyamide or polyurethane. The distal tip 43 and the distal covering portion 40A may be made of the same material or different materials. The length L43 of the distal tip 43 in the longitudinal direction (X-axis direction) can be determined arbitrarily.

As described above, the configuration of the support device 1A can be modified in various ways, and a distal tip 43 may be provided on the distal side of the distal covering portion 40A. The configuration of the distal tip 43 described in FIG. 8 is merely one example, and various modifications are possible. For example, the plate member constituting the distal tip 43 does not need to be biased. The support device 1A of this second embodiment can also achieve the same effects as the first embodiment described above. Furthermore, according to the support device 1A of the second embodiment, the distal tip 43 is fixed to the distal end of the distal covering portion 40A, allowing the distal end of the distal covering portion 40A to be configured more flexibly, thereby improving the safety of the support device 1A. Furthermore, the distal tip 43 is a cylindrically curved plate member, and both circumferential ends 431, 432 of the plate member overlap each other, further preventing a medical device inserted inside (inner cavity) from becoming dislodged. Furthermore, by expanding the gap 433 between both ends 431, 432 of the plate member, a medical device can be easily inserted and removed from the distal tip 43.

Third Embodiment
9 and 10 are explanatory diagrams illustrating the configuration of the distal tip 43B1 to 43B5 of the support device 1B of the third embodiment. In the third embodiment, a modification of the distal tip 43 described in the second embodiment will be described. The support device 1B of the third embodiment has the configuration of the second embodiment, but instead of the distal tip 43, it is equipped with any of the distal tip 43B1 to 43B5 shown in FIGS.

Figure 9(A) is an explanatory diagram illustrating the configuration of the distal tip 43B1. The distal tip 43B1 has end portions 431B1 and 432B1 that gently slope in approximately the same direction as the slit 41 (dashed line) in the distal covering portion 40. Furthermore, the base end of one of the end portions 431B1, 432B1 (end portion 432B1 in the illustrated example) is located at the same circumferential position as the tip of the slit 41 in the distal covering portion 40. Therefore, the distal tip 43B1 in Figure 9(A) allows for easier and faster insertion and removal of a medical device into and from the distal tip 43B1. Note that in this embodiment, "same" and "identical" do not necessarily mean exact agreement, but also mean that differences due to manufacturing errors and the like are acceptable.

Figure 9(B) is an explanatory diagram illustrating the configuration of the distal tip 43B2. The distal tip 43B2 has end portions 431B2 and 432B2 with circumferential notches 434 formed in them. Therefore, with the distal tip 43B2 of Figure 9(B), the notches 434 can be used to more easily and quickly insert and remove a medical device into and from the distal tip 43B2.

Figure 9(C) is an explanatory diagram illustrating the configuration of the distal tip 43B3. The distal tip 43B3 has wavy end portions 431B3 and 432B3. Therefore, with the distal tip 43B3 of Figure 9(C), compared to when straight end portions 431, 432 are provided, the surgeon can more easily grasp end portions 431B3 and 432B3 with their fingers, making it easier and faster to insert and remove a medical device into the distal tip 43B3.

Figure 10(A) is an explanatory diagram illustrating the configuration of the distal tip 43B4. The distal tip 43B4 has U-shaped end portions 431B4 and 432B4. Therefore, with the distal tip 43B4 of Figure 10(A), the number of corners formed at the end portions 431B4 and 432B4 can be reduced compared to when straight end portions 431 and 432 are provided, thereby improving the safety of the distal tip 43B4. Furthermore, compared to when straight end portions 431 and 432 are provided, it is easier for the surgeon to grasp the end portions 431B4 and 432B4 with their fingers, making it easier and faster to insert and remove a medical device into the distal tip 43B4.

Figure 10(B) is an explanatory diagram illustrating the configuration of the distal tip 43B5. The distal tip 43B5 has V-shaped end portions 431B5 and 432B5. Therefore, with the distal tip 43B5 of Figure 10(B), compared to when linear end portions 431, 432 are provided, the surgeon can more easily grasp end portions 431B5 and 432B5 with their fingers, making it easier and faster to insert and remove a medical device into the distal tip 43B5.

As such, the configuration of the distal tips 43B1-43B5 can be modified in various ways, and the end portions 431B1-B5, 432B1-B5 may have various shapes. In the example described above, the shapes of one end and the other end of the plate member for the distal tips 43B1-43B5 are the same. However, the shapes of one end and the other end of the plate member may be different. For example, one end may be wavy and the other end may be straight. Furthermore, for the distal tips 43B2-43B5 described in FIGS. 9(B), (C) and 10(A), (B), similar to the distal tip 43B1 described in FIG. 9(A), the distal end of the slit 41 in the distal covering portion 40 and the base end of one end of the distal tips 43B2-43B5 may be positioned in the same circumferential direction. This third embodiment of the support device 1B can also achieve the same effects as the first and second embodiments described above.

Fourth Embodiment
11 is an explanatory diagram illustrating the configuration of a support device 1C of the fourth embodiment. The support device 1C of the fourth embodiment does not include the base-end covering portion 50 in the configuration of the first embodiment. As described above, the configuration of the support device 1C can be modified in various ways, and the base-end covering portion 50 may be omitted, and only the distal end of the coil body 20 may be covered with a covering portion (distal-end covering portion 40). The support device 1C of this fourth embodiment can also achieve the same effects as the first embodiment described above. Furthermore, in the section where the covering portion (distal-end covering portion 40) is provided, it is possible to prevent the medical device from coming off the gap 22 of the coil body 20.

Fifth Embodiment
12 is an explanatory diagram illustrating the configuration of a support device 1D of the fifth embodiment. The support device 1D of the fifth embodiment does not include the distal covering portion 40 in the configuration of the first embodiment. As described above, the configuration of the support device 1D can be modified in various ways, and the distal covering portion 40 may be omitted, and only the base end of the coil body 20 may be covered with a covering portion (proximal covering portion 50). The support device 1D of the fifth embodiment can also achieve the same effects as the first embodiment described above. Furthermore, in the section where the covering portion (proximal covering portion 50) is provided, it is possible to prevent the medical device from coming off the gap 22 of the coil body 20.

Sixth Embodiment
13 is an explanatory diagram illustrating the configuration of a support device 1E according to a sixth embodiment. The support device 1E according to the sixth embodiment includes a covering portion 60 instead of the distal covering portion 40 and the proximal covering portion 50 in the configuration of the first embodiment.

The covering portion 60 is a member that covers the entire longitudinal section of the outer peripheral surface of the coil body 20. The covering portion 60 has a generally cylindrical (tubular) shape with a distal opening 60a at its distal end and a proximal opening 60b at its proximal end. A slit 61 is provided on the side of the covering portion 60, connecting the distal opening 60a and the proximal opening 60b and providing communication between the inside and outside of the covering portion 60. The slit 61 extends spirally along the gap 22 of the coil body 20. The distal end of the covering portion 60 is located distal to the distal end 28 of the coil body 20, and the distal side of the covering portion 60 includes a section 62 that does not contain the coil body 20. The covering portion 60 has an inner covering portion 63 at its proximal end that covers the inner peripheral surface of the coil body 20. The portion of the covering portion 60 that covers the outer peripheral surface and the portion that covers the inner peripheral surface (inner covering portion 63) are connected at the base end 29 of the coil body 20. The length L60 of the covering portion 60 in the longitudinal direction (X-axis direction) can be determined arbitrarily as long as it is longer than the length of the coil body 20. The covering portion 60 is preferably flexible and can be formed from a resin material such as polyamide, polyolefin, polyester, polyurethane, silicone, fluorine, polyethylene, polycarbonate, or polypropylene. It is particularly preferable that the covering portion 60 be formed from polyamide or polyurethane.

As such, the configuration of the support device 1E can be modified in various ways, and it may be configured to have a covering portion 60 that covers all longitudinal sections of the coil body 20. The configuration of the covering portion 60 illustrated in Figure 13 is merely one example, and for example, the inner covering portion 63 or the section 62 that does not contain the coil body 20 may be omitted. The support device 1E of this sixth embodiment can also achieve the same effects as the first embodiment described above. Furthermore, the support device 1E of the sixth embodiment can prevent the medical device from becoming detached from the gaps 22 of the coil body 20 in all longitudinal sections of the coil body 20.

Seventh Embodiment
Figure 14 is a cross-sectional view of a support device 1F of the seventh embodiment taken along line A-A (Figure 1). The support device 1F of the seventh embodiment has the configuration of the first embodiment, but with a distal covering portion 40F instead of the distal covering portion 40. The distal covering portion 40F has an outer covering portion 401 that covers the outer peripheral surface of the coil body 20 and an inner covering portion 402 that covers the inner peripheral surface of the coil body 20. A slit 41 is provided on the side surface of the distal covering portion 40F, connecting the distal opening 40a and the proximal opening 40b (see Figure 1) and providing communication between the inside and outside of the distal covering portion 40F. As shown in Figure 14, the slit 41 is provided at the same position on both the outer covering portion 401 and the inner covering portion 402.

As described above, the configuration of the support device 1F can be modified in various ways. For example, the support device 1F may include a distal covering portion 40F having an outer covering portion 401 covering the outer peripheral surface of the coil body 20 and an inner covering portion 402 covering the inner peripheral surface of the coil body 20. With this configuration, the inner covering portion 402 can protect the medical device inserted through the device lumen 20L, further reducing damage to the medical device. Note that FIG. 14 illustrates a configuration in which a gap 403 is provided between the outer covering portion 401 and the inner covering portion 402. However, this gap 403 is not necessary. For example, in the portion of the distal covering portion 40F where the coil body 20 is not enclosed, the outer covering portion 401 and the inner covering portion 402 may be in contact with each other. Furthermore, while the example of FIG. 14 illustrates the distal covering portion 40F, the proximal covering portion 50 may also be configured to have an outer covering portion covering the outer peripheral surface of the coil body 20 and an inner covering portion covering the inner peripheral surface of the coil body 20.

Eighth Embodiment
15 is an explanatory diagram illustrating the configuration of a support device 1G of an eighth embodiment. The support device 1G of the eighth embodiment includes a coil body 20G instead of the coil body 20 in the configuration of the first embodiment. The coil body 20G is a single-strand coil formed by winding a single wire 21. The outer diameter, inner diameter, and length of the coil body 20G, as well as the winding direction of the wire 21, can be determined arbitrarily.

As such, the configuration of the coil body 20G can be modified in various ways. Instead of the multi-strand coil described in the first embodiment, a single-strand coil as shown in FIG. 15 may be used. Furthermore, the coil body 20G may be a single-strand stranded coil formed by winding a single strand of a stranded wire made by twisting together multiple strands of wire, or a multi-strand stranded coil formed by using multiple strands of wire twisted together and winding each strand multiple times. Furthermore, the coil pitch of the coil body 20G does not have to be constant. For example, by making the coil pitch at the base end larger than the coil pitch at the distal end, the rigidity of the base end of the coil body 20G can be made higher than that at the distal end. Similarly, the coil pitch does not have to be constant in the multi-strand coil (coil body 20) described in the first embodiment. The support device 1G of this eighth embodiment can also achieve the same effects as the first embodiment described above.

Ninth Embodiment
FIG. 16 is an explanatory diagram illustrating the configuration of a support device 1H according to a ninth embodiment. The support device 1H of the ninth embodiment includes a shaft portion 10H instead of the shaft portion 10 in the configuration of the first embodiment. The shaft portion 10H includes a main body portion 11 and a grip portion 30. The main body portion 11 is a hollow, approximately cylindrical member extending along the longitudinal direction (X-axis direction) and having a substantially constant outer diameter from the distal end to the proximal end. Note that the entire main body portion 11, 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 curved portion 32 of the grip portion 30 is inserted and fixed to the distal end of the main body portion 11. The main body portion 11 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 bonding using any adhesive. The main body portion 11 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 peripheral surface of the main body portion 11 .

Figure 17 is an explanatory diagram illustrating the configuration of the gripping portion 30. Figure 17(A) shows the configuration of the gripping portion 30 as viewed from the same direction as Figure 16. Figure 17(B) shows the configuration of the gripping portion 30 as viewed from the +Y direction of Figure 16. The gripping portion 30 is a member provided at the tip of the shaft portion 10H, between the main body portion 11 and the coil body 20. 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 1H. As shown in Figure 17(A), 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 curved. The gripping portion 30 grips the coil body 20 inserted into the gap 30a. Specifically, as shown in Figure 16, the coil body 20 is gripped by clamping it between grippers 31 from both the outer and inner circumferential sides of the coil body 20. The lengths of the grippers 30 in the X-axis and Z-axis directions can be determined as desired.

As such, the configuration of the support device 1H can be modified in various ways, and a shaft portion 10H composed of a main body portion 11 and a gripping portion 30 may be used. The support device 1H of this ninth embodiment can also achieve the same effects as the first embodiment described above. Furthermore, according to the support device 1H of the ninth embodiment, the shaft portion 10H includes gripping portions 30 that grip the coil body 20 by sandwiching it from both the outer and inner peripheral surfaces of the coil body 20. Therefore, compared to simply joining the coil body 20 and the shaft portion 10H, the coil body 20 and the shaft portion 10H can be reliably fixed with a simpler structure.

Tenth Embodiment
FIG. 18 is an explanatory diagram illustrating the configuration of the gripping portion 30 of the tenth embodiment. The support device 1I of the tenth embodiment has the configuration described in the ninth embodiment, but instead of the gripping portion 30 described in FIG. 17, it includes a gripping portion 30I shown in FIG. 18. FIG. 18(A) shows the configuration of the gripping portion 30I as seen from the same direction as FIG. 16. FIG. 18(B) shows the configuration of the gripping portion 30I as seen from the +Y direction of FIG. 16. FIG. 18(C) shows the coil body 20 being gripped by the gripping portion 30I as seen from the +Y direction of FIG. Note that in FIG. 18(C), for convenience of illustration, a portion of the coil body 20 is simplified to be a curved plate.

As shown in Figure 18 (B), the gripping portion 30I has a gripping body 31I and a main body 32I. The gripping body 31I is a portion in which multiple (three in the example of Figure 18) plate-like members are arranged side by side in the Z-axis direction with a predetermined gap between them. The main body 32I is a solid, approximately cylindrical member with a substantially constant outer diameter from the tip to the base end. As shown in Figure 18 (C), the gripping body 31I grips the coil body 20 by sandwiching the coil body 20 between the multiple plate-like members. Specifically, as shown in FIG. 18(C), of the multiple plate-shaped members that make up gripper 31I, some of the plate-shaped members (in the illustrated example, the odd-numbered plate-shaped members when viewed from the +Z-axis direction) are positioned on the outer circumferential surface side of coil body 20, and the remaining plate-shaped members (in the illustrated example, the even-numbered plate-shaped members when viewed from the +Z-axis direction) are positioned on the inner circumferential surface side of coil body 20, thereby allowing gripper 31I to grip coil body 20.

As such, the configuration of the grip portion 30I can be modified in various ways, and may be configured differently from the configuration described in FIG. 17. The support device 1I of the tenth embodiment, which includes such a grip portion 30I, can also achieve the same effects as the first and ninth embodiments described above. Furthermore, with the grip portion 30I of the tenth embodiment, there is no need to provide the curved portion 32 described in the ninth embodiment, so the base end side of the grip portion 30I (i.e., the main body portion 32I) can be made thinner.

<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.

[Modification 1]
In the first to tenth embodiments described above, the configurations of the support devices 1, 1A to 1I have been illustrated. However, various modifications are possible to the configuration of the support device 1. For example, in the ninth and tenth embodiments, the main body 11 and the gripping portion 30, 30I 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 coil body 20 or the distal end of the distal covering portion 40). For example, a connector may be provided at the proximal end of the support device 1 (i.e., the proximal end of the shaft portion 10) to allow the surgeon to grasp the support device 1. For example, the surfaces of at least some of the members of the shaft portion 10, the coil body 20, the distal covering portion 40, and the proximal covering portion 50 may be coated with a hydrophilic or hydrophobic resin.

[Modification 2]
The configurations of the support devices 1, 1A to 1I of the first to tenth embodiments and the configurations of the first modified example may be combined as appropriate. For example, the distal tip 43 described in the second and third embodiments may be employed in the support device 1 having the configuration described in the fourth, sixth to tenth embodiments. For example, the coil body 20G described in the eighth embodiment may be employed in the support device 1 having the configuration described in the second to seventh, ninth, and tenth embodiments. For example, the shaft portion 10H described in the ninth embodiment may be employed in the support device 1 having the configuration described in the second to eighth embodiments.

This aspect has been described above based on embodiments and variations, but 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 its spirit or the scope of the claims, and equivalents are included in this aspect. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate.

DESCRIPTION OF SYMBOLS 1, 1A to 1I... Support device 2... Guide wire 3... Balloon catheter 4... Guiding catheter 10, 10H... Shaft portion 11... Main body portion 20, 20G... Coil body 21... Wire 22... Gap 30, 30I... Grip portion 31, 31I... Grip body 32... Curved portion 32I... Main body portion 40, 40A, 40F... Tip side covering portion (covering portion)
40a... Distal end opening 40b... Proximal end opening 41... Slit 43, 43B1, 43B2, 43B3, 43B4, 43B5... Distal tips 50... Proximal end covering portion (covering portion)
50a... Distal opening 50b... Base opening 51... Slit 52... Inner covering portion 60... Covering portion 60a... Distal opening 60b... Base opening 61... Slit 63... Inner covering portion 90... Aorta 91... Coronary artery 92... First branch 93... Second branch 99... Stenosis portion 301... Balloon 401... Outer covering portion 402... Inner covering portion 403... Gap 431, 431B1, 431B2, 431B3, 431B4, 431B5, 432, 432B1, 432B2, 432B3, 432B4, 432B5... End portion 433... Gap

Claims (6)

A support device for supporting a medical device that is inserted into a biological lumen and used ,
a shaft portion having an elongated outer shape;
a coil body having an elongated outer shape provided at the tip of the shaft portion;
a covering portion that covers at least a portion of a longitudinal section of an outer circumferential surface of the coil body;
Equipped with
The covering portion is
It has a distal opening provided at the distal end and a proximal opening provided at the proximal end,
a slit is provided on a side surface of the covering portion, the slit connecting the tip-end side opening and the base-end side opening and communicating the inside and outside of the covering portion, the slit extending along the gap of the coil body ,
The support device supports the medical device with a distal end portion of the medical device protruding from the distal end opening and a portion of the medical device housed inside the coil body . 10. The support device of claim 1,
The coil body is formed by winding a flat plate-shaped member around it,
the covering portion includes a base-end covering portion that covers a base end portion of the coil body,
a support device in which the base-end covering portion covers an inner peripheral surface of the coil body in addition to an outer peripheral surface of the coil body, and the portion covering the outer peripheral surface and the portion covering the inner peripheral surface are connected at the base end of the coil body. 3. A support device according to claim 1 or claim 2,
the covering portion includes a tip side covering portion that covers a tip end portion of the coil body,
A support device, wherein the tip of the tip side covering portion is located more distal than the tip of the coil body. 3. A support device according to claim 1 or claim 2,
the covering portion includes a tip side covering portion that covers a tip end portion of the coil body,
a distal tip is fixed to the distal end of the distal covering part;
The tip tip is a support device that is a cylindrically curved plate member, with both circumferential ends of the plate member overlapping each other, and by expanding the gap between the two ends, the medical device can be inserted and removed into the tip tip. 5. The support device of claim 4,
A support device, wherein the distal end of the slit of the distal covering portion and the base end of one of the two end portions of the distal tip are at the same position in the circumferential direction. A support device according to any one of claims 1 to 5,
The shaft portion
a main body portion extending along a longitudinal direction;
a gripping portion provided at a tip end of the main body portion and configured to grip the coil body, the gripping portion sandwiching the coil body from both an outer peripheral surface side and an inner peripheral surface side of the coil body to grip the coil body;
A support device comprising: