conduit

Abstract

A catheter has a shaft that includes a wire lumen, a sensor lumen, a protrusion, and a first cutout. The sensor lumen is arranged side by side with the wire lumen. The protrusion includes the wire lumen and protrudes further forward than a leading end of the sensor lumen, and a leading end opening that communicates with the wire lumen is formed at the leading end. The first cutout is a cutout that is formed at a position closer to a base end side than the protrusion and that communicates with the wire lumen. The first cutout is formed in a side surface of the shaft on an opposite side of the sensor lumen with reference to a center axis of the wire lumen. In a section in which the first cutout is formed, the shaft has a bottom opposite the first cutout and a pair of side walls that extend toward the opposite side of the sensor lumen.

Description

Technical Field

[0001] This invention relates to a catheter. Background Technology

[0002] In cases like chronic total occlusion (CTO), the blood vessel is blocked by an occluder. During CTO recanalization, typically, after advancing the catheter to the CTO lesion using a guidewire, a through-guidewire is used to re-enter the true lumen from the false lumen. It's important to note that the false lumen refers to any isolated lumen outside the true lumen created by the medical device.

[0003] Because the procedure for opening a CTO is complex, it requires sensor guidance (e.g., IVUS guide). For example, Patent Documents 1-3 disclose a catheter that can be used in sensor-guided surgery. The catheters in Patent Documents 1-3 each have a sensor lumen (image lumen) and a wire lumen (guidewire lumen), and can manipulate the guidewire inserted into the wire lumen while observing through a sensor inserted into the sensor lumen.

[0004] Existing technical documents

[0005] Patent documents

[0006] Patent Document 1: Japanese Patent No. 4065167

[0007] Patent Document 2: Japanese Patent Application Publication No. 2017-153621

[0008] Patent Document 3: Japanese Patent Application Publication No. 2018-33507 Summary of the Invention

[0009] The problem that the invention aims to solve

[0010] Here, the catheter inserted into the blood vessel is preferably a catheter with the smallest possible diameter. Regarding this, in the catheters described in Patent Documents 1 and 2, the delivery guidewire and the penetration guidewire can share a single wire lumen, thus enabling a smaller catheter diameter. On the other hand, in the catheters described in Patent Documents 1 and 2, the wire lumen extending along the length of the catheter is composed of a first guidewire lumen and a second guidewire lumen, with a region without a guidewire lumen between the first and second guidewire lumen. Therefore, in the catheters described in Patent Documents 1 and 2, there is a problem that when the delivery guidewire is inserted into the catheter, it may dislodge in this region without a guidewire lumen, reducing ease of use. Furthermore, in the catheter described in Patent Document 3, although the ease of use is increased due to the presence of three wire lumens, there is a problem with the catheter having a larger diameter.

[0011] It should be noted that such challenges are not limited to the opening of the CTO (Cyclic Transmission Toxic) device. These challenges also exist for instruments used in surgery while changing different medical devices, such as delivery guidewires and perforation guidewires. Furthermore, these challenges are not limited to the vascular system; they also exist for instruments inserted into the lumens of other biological systems, such as the lymphatic system, biliary system, urinary system, respiratory system, digestive system, endocrine glands, and reproductive organs.

[0012] The present invention was made to solve at least some of the above-mentioned problems, and its object is to achieve both a small diameter and improved ease of use in a catheter that enables surgery to be performed under sensor guidance and while changing different medical devices.

[0013] Methods for solving problems

[0014] The present invention was made to solve at least some of the above-mentioned problems, and the present invention can be implemented in the following manner.

[0015] (1) According to one aspect of the present invention, a conduit having a shaft is provided. In this conduit, the shaft comprises: a filament lumen extending along the length of the shaft; a sensor lumen arranged side-by-side with the filament lumen; a protrusion including the filament lumen and protruding further forward than the front end of the sensor lumen, the protrusion having a front opening communicating with the filament lumen at its front end; and a first cut portion, the first cut portion being a cut communicating with the filament lumen formed at a position closer to the base end than the protrusion. The first cut portion is formed on a side surface of the shaft located on the opposite side of the sensor lumen with reference to the central axis of the filament lumen. In the section where the first cut portion is formed, the shaft has a bottom opposite to the first cut portion and a pair of sidewalls extending from the bottom toward the opposite side of the sensor lumen.

[0016] According to this structure, a catheter can be provided that, because the catheter shaft includes a wire lumen and a sensor lumen arranged parallel to the wire lumen, allows for surgery guided by a sensor (e.g., IVUS) inserted into the sensor lumen, and allows for surgery to be performed while changing different medical devices (e.g., delivery guidewires and through guidewires) in the wire lumen. Furthermore, because a front opening is formed at the front end of the protrusion, the delivery guidewire can be easily inserted into the wire lumen through this front opening. In the section where the first incision is formed, the shaft has a bottom opposite to the first incision and a pair of sidewalls extending from the bottom toward the opposite side of the sensor lumen. Therefore, when the delivery guidewire in the wire lumen is advanced towards the base end, the delivery guidewire can be supported by the sidewalls provided in the section with the first incision, thus preventing the delivery guidewire from dislodging and flying outwards from the shaft. Furthermore, since a first incision is formed on the side surface of the shaft opposite to the sensor lumen, the guidewire can be easily protruded outward from this first incision. At this time, the tip of the guidewire can be pushed outward using the sidewall provided in the section with the first incision, thus allowing the tip of the guidewire to protrude precisely into the target tissue. As a result, according to this structure, a catheter capable of performing surgery under sensor guidance and simultaneously changing different medical devices can achieve both a smaller diameter and improved ease of use.

[0017] (2) In the catheter described above, when the axis is viewed from the lumen side of the filament, the first incision may be elliptical in shape, having a first major axis extending along the central axis of the filament lumen and a first minor axis extending perpendicular to the central axis. The length of the first minor axis is equal to the inner diameter of the filament lumen.

[0018] According to this structure, since the first incision is elliptical in shape and the length of the first minor axis of the first incision is equal to the inner diameter of the wire lumen, the first incision can be positioned over a wide circumferential range relative to the wire lumen. Therefore, when the catheter is inserted into the lumen of a living organism, even if the position of the first incision of the catheter is separated from the target tissue in the circumferential direction, the tip of the guidewire can be easily directed toward the target tissue without rotating the catheter.

[0019] (3) In the conduit of the above manner, the shaft may also include a second incision, which is an incision formed at a position closer to the front end or base end than the first incision and communicating with the lumen of the filament. The second incision is formed on the side surface of the shaft on the same side as the first incision. In the section where the second incision is formed, the shaft has a bottom opposite to the second incision and a pair of sidewalls extending from the bottom toward the opposite side of the sensor lumen.

[0020] According to this structure, since a second cut is formed on the side surface of the shaft, closer to the front end or the base end than the first cut, the guide wire can be selectively protruded outward from either the first or second cut. Furthermore, in the section where the second cut is formed, the shaft has a bottom opposite the second cut and a pair of sidewalls extending from the bottom towards the opposite side of the sensor lumen. Therefore, when the guide wire is advanced towards the base end within the wire lumen, the guide wire is supported by the sidewalls in the section with the second cut, preventing it from detaching and flying outward from the shaft. Moreover, since the front end of the guide wire can be pushed outward using the sidewalls in the section with the second cut, the front end of the guide wire can be protruded towards the target tissue with high precision.

[0021] (4) In the catheter described above, when viewing the axis from the lumen side of the filament, the second incision may be elliptical in shape, having a second major axis extending along the central axis of the filament lumen and a second minor axis extending perpendicular to the central axis. The length of the second minor axis is equal to the inner diameter of the filament lumen, and the length of the second major axis is shorter than the length of the first major axis of the first incision.

[0022] According to this structure, since the second incision is elliptical in shape and the length of its second minor axis is equal to the inner diameter of the wire lumen, the second incision can be positioned over a wide circumferential range relative to the wire lumen. Therefore, when inserting the catheter into a biological lumen, even if the second incision is separated from the target tissue circumferentially, the tip of the guidewire can be easily aligned with the target tissue without rotating the catheter. Furthermore, since the length of the second major axis of the second incision is shorter than the length of the first major axis of the first incision, the length of the second incision in the axial direction can be shorter than that of the first incision. Therefore, compared to the first incision, the tip of the guidewire can be more easily positioned relative to the target tissue through the second incision. The surgeon can selectively use the first and second incisions separately depending on the positional relationship between the catheter and the target tissue, the size of the target tissue, etc., thus further improving the ease of catheter use.

[0023] (5) In the catheter described above, the shaft may further include: a branch lumen branching from the filament lumen between the front end and the base end of the shaft; and a branch portion formed at the connection between the filament lumen and the branch lumen. Regarding the branch lumen, the front end side of the branch lumen is connected to the filament lumen; the base end side of the branch lumen is located closer to the base end side of the shaft than the front end side; the base end side of the branch lumen communicates with the outside through a port formed on the side surface of the shaft. The branch portion has: a larger diameter portion, the inner diameter of which is larger than the inner diameter of the lumen of other portions of the filament lumen; and a boundary wall separating the filament lumen from the branch lumen at a position closer to the base end than the larger diameter portion.

[0024] According to this structure, since a front opening is formed at the front end of the protrusion on the shaft of the catheter, the guidewire can be easily inserted into the lumen of the wire material through this front opening. Here, the base end of the branch lumen branching from the wire material lumen communicates with the outside through a port formed on the side surface of the shaft. Therefore, since the base end of the guidewire in the wire material lumen can be pulled outward from this port, the guidewire can be quickly inserted into the catheter. Furthermore, the branch portion formed at the connection between the wire material lumen and the branch lumen has a boundary wall that separates the wire material lumen from the branch lumen. Therefore, when the guidewire is inserted into the wire material lumen from the base end of the shaft and advanced towards the front end of the shaft, the front end of the guidewire can be prevented from moving towards the branch lumen by contacting the boundary wall. As a result, according to this structure, a catheter that can perform surgery under sensor guidance and can perform surgery while changing different medical devices can be achieved, thus balancing the need for a smaller diameter and improved ease of use.

[0025] (6) In the above-described conduit, the port may be inclined relative to the central axis of the shaft, and the front end of the boundary wall may be located at the same position as the front end of the port, or at a position closer to the front end than the front end of the port, along the length of the shaft.

[0026] According to this structure, along the length of the shaft, the front end of the boundary wall is located at the same position as the front end of the port, or at a position closer to the front end than the front end of the port. Therefore, when the guide wire is inserted into the wire tube from the base end of the shaft and advanced towards the front end of the shaft, the front end of the guide wire can be reliably prevented from moving towards the branch tube.

[0027] (7) In the above-described conduit, the length of the boundary wall along the axis can also be greater than or equal to the length of the port along the axis.

[0028] According to this structure, since the length of the boundary wall in the longitudinal direction of the axis is greater than the length of the port in the longitudinal direction of the axis, when the through guide wire is inserted into the wire tube from the base end side of the axis and pushed towards the front end side of the axis, the front end of the through guide wire can be reliably prevented from heading towards the branch tube.

[0029] (8) In the above-described conduit, the branch portion may also have a raised portion, which is formed by a region on the inner circumferential surface of the filament lumen that is closer to the front end than the coarse diameter portion and opposite to the extension side of the branch lumen, rising toward the extension side of the branch lumen.

[0030] According to this structure, since the branch also has a raised portion, the filament can be guided through the raised portion.

[0031] (9) In the conduit constructed in the above manner, in the first case where the filament is inserted into the filament lumen from the front opening, the base end of the filament is guided toward the branch lumen by contacting the raised portion. In the second case where the filament is inserted into the filament lumen from the base end side of the shaft, the front end of the filament is prevented from moving toward the branch lumen by contacting the boundary wall.

[0032] According to this structure, in the first case where the guidewire is inserted into the wire lumen from the front opening, the base of the guidewire is guided toward the branch lumen by contacting the raised portion. In other words, in the first case where the catheter is used as a Rapid Exchange (Rx type) catheter, the raised portion improves the ease of use as an Rx type catheter by guiding the base of the guidewire toward the branch lumen with the port. Furthermore, in the second case where the universal guidewire is inserted into the wire lumen from the base end side of the shaft, the boundary wall of the branch portion prevents the front end of the universal guidewire from moving toward the branch lumen by contacting the boundary wall. In other words, in the second case where the catheter is used as an over-the-wire (OTW type) catheter, the boundary wall improves the ease of use as an OTW type catheter by guiding the front end of the universal guidewire toward the front end of the wire lumen. Thus, this structure allows for the sharing of the wire lumen by different medical devices (guidewire and universal guidewire), thereby enabling catheter reduction in diameter.

[0033] It should be noted that the present invention can be implemented in various ways, such as by means of catheters, methods of manufacturing or using catheters, catheter systems including catheters and sensors, guidewires and other devices for conveying guidewires, methods of manufacturing or using catheter systems, etc. Attached Figure Description

[0034] Figure 1 This is an illustrative diagram illustrating the structure of a re-opening duct system.

[0035] Figure 2 This is an illustrative diagram illustrating the structure at a portion of the tip side of the catheter.

[0036] Figure 3 This is an example from Figure 2 An illustrative diagram of the structure of the duct as observed from direction A.

[0037] Figure 4 This is an illustrative diagram illustrating the cross-sectional structure of a catheter.

[0038] Figure 5 This is an illustrative diagram illustrating the cross-sectional structure of a catheter.

[0039] Figure 6 This diagram illustrates the movement of the raised portion in the first scenario.

[0040] Figure 7 This diagram illustrates the action of the boundary wall in the second scenario.

[0041] Figure 8 This is a schematic diagram of the imaging sensor.

[0042] Figure 9 This diagram illustrates how to use a recanalization catheter system.

[0043] Figure 10 This diagram illustrates how to use a recanalization catheter system.

[0044] Figure 11 This is an explanatory diagram illustrating the structure of a portion of the distal end of the catheter according to the second embodiment.

[0045] Figure 12 This is an explanatory diagram illustrating the structure of a portion of the distal end of the catheter according to the third embodiment.

[0046] Figure 13 This is an explanatory diagram illustrating the structure of a portion of the distal end of the catheter according to the fourth embodiment.

[0047] Figure 14 This is an explanatory diagram illustrating the cross-sectional structure of the catheter according to the fifth embodiment.

[0048] Figure 15 This is an explanatory diagram illustrating the cross-sectional structure of the conduit according to the sixth embodiment.

[0049] Figure 16 This is an explanatory diagram illustrating the cross-sectional structure of the catheter according to the seventh embodiment.

[0050] Figure 17 This is an explanatory diagram illustrating the structure of a portion of the distal end of the catheter according to the eighth embodiment.

[0051] Figure 18 This is an explanatory diagram illustrating the structure of a portion of the distal end of the catheter according to the ninth embodiment. Detailed Implementation

[0052] <First Implementation>

[0053] Figure 1 This is an illustrative diagram illustrating the structure of a recanalization catheter system 1. The recanalization catheter system 1 is used, for example, in treating CTO (Chronic Total Occlusion) in a blood vessel using the antegrade approach. The recanalization catheter system 1 includes a catheter 100, an imaging sensor 200, an imaging console 300, and a through-wire 400. Figure 1 The diagram shows a schematic side view of the catheter 100, with dashed lines indicating a portion of the front end of the imaging sensor 200 inserted into the catheter 100 and a portion of the front end of the guidewire 400 penetrating through it.

[0054] exist Figure 1For ease of explanation, the relative sizes of structural components are sometimes described as different from actual dimensions. Additionally, portions of structural components are sometimes described in an exaggerated manner. Furthermore, in... Figure 1 The diagram shows mutually orthogonal XYZ axes. The X-axis corresponds to the length direction of catheter 100, the Y-axis corresponds to the height direction of catheter 100, and the Z-axis corresponds to the width direction of catheter 100. Figure 1 The left side (in the -X axis direction) is referred to as the "front end side" of the conduit 100 and its various structural components. Figure 1 The right side (in the +X axis direction) is referred to as the "base side" of the catheter 100 and its various structural components. Furthermore, of the two ends along the length (X axis direction) of the catheter 100 and its various structural components, the end located on the anterior side is called the "anterior end," and the end located on the base side is called the "base end." Additionally, the anterior end and its vicinity are called the "anterior portion," and the base end and its vicinity are called the "base portion." The anterior side is inserted into the organism, while the base side is operated on by the surgeon or other operator. These points are... Figure 1 This principle will also be consistent in subsequent diagrams.

[0055] Figure 2 This is an illustrative diagram illustrating the structure at a portion of the front end side of the catheter 100. Figure 3 This is an example from Figure 2 An illustrative diagram of the structure of catheter 100 as observed from direction A. Figure 3 The lower half of the dashed box shows an enlarged sectional view near branch 150. Figure 2 as well as Figure 3 The upper part, shown by dashed lines, illustrates the wire lumen 150L and sensor lumen 160L formed inside the conduit 100. Additionally, in Figure 2 and Figure 3 In one part, the central axis O of the wire tube 150L is shown with a single-dotted line.

[0056] Figure 4 as well as Figure 5 This is an illustrative diagram illustrating the cross-sectional structure of guidewire 100. Figure 4 (A) is Figure 2 A cross-sectional view of the conduit 100 cut along line B1-B1. Figure 4 (B) is Figure 2 A cross-sectional view of the conduit 100 cut along line B2-B2. Figure 5 yes Figure 2 A cross-sectional view of the conduit 100 cut along line CC. The following uses... Figures 1-5 The structure of guidewire 100 will be described. It should be noted that... Figures 2-5 The imaging sensor 200 and the through-wire 400 are not shown in the figure.

[0057] like Figure 1 As shown, the conduit 100 includes a shaft 110 and an adjuster 105. (As indicated...) Figure 2 as well as Figure 3 As shown, shaft 110 has a wire tube 150L, ​​a sensor tube 160L, a protrusion 112, a cutout 130, and a branch 150. Figure 3 ).

[0058] like Figure 2 As shown, the wire tube 150L and the sensor tube 160L are tubes extending along the length direction (X-axis direction) of the shaft 110. Inside the shaft 110, the wire tube 150L and the sensor tube 160L are arranged side by side in a manner that is approximately parallel to each other.

[0059] The sensor cavity 160L extends linearly from the front end of the shaft 110 to the base end. On the other hand, as... Figure 3 As shown, the wire tube 150L branches into two strands between the front end and the base end of the shaft 110 (for example, at any position approximately 200mm to 400mm from the front end). One branch extends approximately in a straight line to the base end of the shaft 110, while the other branch communicates with the outside via a port 110e formed on the side surface of the shaft 110. Hereinafter, the tube branching from the wire tube 150L and connecting to the port 110e will be referred to as the "branch tube 150Lb". Furthermore, the periphery of the connection between the wire tube 150L and the branch tube 150Lb in the shaft 110 will be referred to as the "branch portion 150". Details regarding the branch portion 150 and the branch tube 150Lb will be explained later.

[0060] like Figure 2 As shown, a portion of the front end of the wire tube 150L is located closer to the front end (in the -X-axis direction) than the front end of the sensor tube 160L. Hereinafter, the portion of the shaft 110 surrounding this portion of the front end of the wire tube 150L will be referred to as the "protrusion 112". It should be noted that the lengths of the wire tube 150L and the sensor tube 160L in the X-axis direction can be arbitrarily determined as long as the wire tube 150L is longer than the sensor tube 160L.

[0061] As described above, the protrusion 112 is the portion of the shaft 110 that protrudes further towards the front end than the front end of the sensor cavity 160L, and a portion of the front end of the wire cavity 150L is included inside the protrusion 112. A front end tip 120 engages with a portion of the front end of the protrusion 112 in a manner that surrounds the protrusion 112. The front end tip 120 is a generally cylindrical component with an R-shaped tip. It should be noted that the front end tip 120 can be of any shape, for example, it can be a generally frustum-shaped cone with its outer diameter tapering from the base end towards the front end. The front end tip 120 can be colored to improve visual legibility, or it can be formed of a material that is radiopaque. For the engagement of the front end tip 120 with the shaft 110, for example, a resin-to-resin bonding process performed by heat melting can be used, or a bonding process performed with an insulating adhesive such as an epoxy adhesive can be used.

[0062] In the shaft 110, at a position corresponding to the front end of the wire tube 150L (in other words, the front end of the protrusion 112), a first front opening 110a is provided to communicate the wire tube 150L with the outside. The first front opening 110a is equivalent to a "front opening". In the shaft 110, at a position corresponding to the base end of the wire tube 150L, ​​a first base opening 110c is provided to communicate the wire tube 150L with the outside. Figure 1 Additionally, in shaft 110, at a position corresponding to the front end of sensor cavity 160L, a second front opening 110b is provided to connect sensor cavity 160L to the outside. In shaft 110, at a position corresponding to the base end of sensor cavity 160L, a second base opening 110d is provided to connect sensor cavity 160L to the outside. Figure 1 ).

[0063] In this embodiment of the conduit 100, the second opening 110b at the front end is located closer to the base end than the first opening 110a at the front end. Furthermore, the second opening 110b at the front end is inclined relative to the length direction (X-axis direction) of the shaft 110. The second opening 110b at the front end is an opening for discharging fluid injected into the sensor cavity 160L from the second opening 110d at the base end. Therefore, the second opening 110b at the front end can also be perpendicular to the length direction of the shaft 110. Alternatively, the second opening 110b at the front end may not be located at a position corresponding to the front end of the sensor cavity 160L; it can simply be located at a position where a portion near the front end of the sensor cavity 160L communicates with the outside.

[0064] like Figure 4 As shown in (A), shaft 110 has an outer shaft 114, a first inner shaft 115, a second inner shaft 116, and a sealing member 111.

[0065] The outer shaft 114, the first inner shaft 115, and the second inner shaft 116 are all hollow elongated shapes. The outer shaft 114 has a generally elliptical cross-section. The first inner shaft 115 and the second inner shaft 116 have generally circular cross-sections. The first inner shaft 115 and the second inner shaft 116 are inserted into the cavity of the outer shaft 114 and extend approximately parallel to each other along the length of the outer shaft 114. The cavity of the first inner shaft 115 functions as the aforementioned wire cavity 150L. On the other hand, the cavity of the second inner shaft 116 functions as the aforementioned sensor cavity 160L. Figure 4 As shown in (A), the inner diameter Φ150 of the first inner shaft 115 (the inner diameter of the wire tube 150L) is smaller than the inner diameter Φ160 of the second inner shaft 116 (the inner diameter of the sensor tube 160L). It should be noted that the inner diameters Φ150 and Φ160 can be arbitrarily determined.

[0066] The sealing component 111 seals (fixes) the first inner shaft 115 and the second inner shaft 116 within the outer shaft 114. The sealing component 111 is disposed inside the outer shaft 114 and outside the first inner shaft 115 and the second inner shaft 116. The joint of the outer shaft 114, the first inner shaft 115, the second inner shaft 116, and the sealing component 111 can be achieved, for example, by bonding resins through heat fusion or by bonding with an insulating adhesive such as an epoxy adhesive.

[0067] like Figure 2 As shown, the cut portion 130 is a cut formed on the shaft 110 that is closer to the base end side than the protrusion 112, and is a cut that connects the wire tube 150L to the outside. In this embodiment, the cut portion 130 includes two cut portions (first cut portion 131 and second cut portion 132).

[0068] The first cutout 131 is formed in the side surface of the shaft 110, on the side surface opposite to the sensor cavity 160L, with the central axis O of the wire cavity 150L as a reference. For example... Figure 3 As shown, when viewing the shaft 110 from the side of the wire tube 150L, ​​the first cut 131 is elliptical in shape, having a major axis (hereinafter also referred to as the "first major axis") extending along the central axis O of the wire tube 150L and a minor axis (hereinafter also referred to as the "first minor axis") extending perpendicular to the central axis O. Figure 3 and Figure 4 As shown, the length L131a of the first short axis of the first cut portion 131 is equal to the inner diameter Φ150 of the wire tube cavity 150L. It should be noted that in this embodiment, "equal" means approximately the same, and differences caused by manufacturing errors, etc., are allowed.

[0069] like Figure 4As shown in (B), in the section where the first cutout 131 is formed, the shaft 110 has a bottom 1311 and a pair of sidewalls 1312. The bottom 1311 is the portion of the shaft 110 opposite to the first cutout 131. The sidewalls 1312 are the portions of the shaft 110 that extend from the bottom 1311 toward the opposite side of the sensor cavity 160L. In other words, the shaft 110 has a generally semi-circular groove surrounded by the bottom 1311 and the sidewalls 1312 in the section where the first cutout 131 is formed.

[0070] like Figure 2 As shown, the second cut 132 is located closer to the front end than the first cut 131. The second cut 132 is formed on the side surface of the shaft 110 on the same side as the first cut 131 (i.e., on the side surface opposite to the sensor cavity 160L with reference to the central axis O of the wire cavity 150L). Figure 3 As shown, when viewing the shaft 110 from the side of the wire tube cavity 150L, ​​the second cutout 132 is elliptical in shape, having a major axis (hereinafter also referred to as the "second major axis") extending along the central axis O of the wire tube cavity 150L and a minor axis (hereinafter also referred to as the "second minor axis") extending perpendicular to the central axis O. The length L132a of the second minor axis of the second cutout 132 is equal to the inner diameter Φ150 of the wire tube cavity 150L. In the section where the second cutout 132 is formed, the shaft 110 has a bottom opposite to the second cutout 132 and a pair of sidewalls extending from the bottom to the opposite side of the sensor cavity 160L. The details are the same as those of the first cutout 131.

[0071] like Figure 3 As shown, the length L132b of the second major axis of the second cut portion 132 is shorter than the length L131b of the first major axis of the first cut portion 131. Therefore, as Figure 3 As shown, when viewing the shaft 110 from the wire tube lumen 150L side, the area of ​​the elliptical shape of the second cut portion 132 is smaller than the area of ​​the elliptical shape of the first cut portion 131. It should be noted that the length L132b of the second major axis of the second cut portion 132 refers to the length of the shaft 110 when viewed from the wire tube lumen 150L side (…). Figure 3 The length between the front end and the base end of the ellipse of the second cut portion 132 (from the perspective of the viewpoint). The same applies to the length L131b of the first major axis of the first cut portion 131.

[0072] like Figure 2 and Figure 3As shown, a mark 141 is joined between the first cutout 131 and the second cutout 132 on the outer peripheral surface of the shaft 110. The mark 141 is a semi-circular component provided along the outer peripheral surface of the shaft 110. The mark 141 can be colored to improve visual recognition, or it can be formed of a material that is radiopaque. The joining of the mark 141 to the shaft 110 can be, for example, by bonding resins through heat melting, or by bonding with an insulating adhesive such as an epoxy adhesive.

[0073] It should be noted that, in this embodiment, the second cut 132 may also be located closer to the front end than the first cut 131. However, the second cut 132 may also be located closer to the base end than the first cut 131. Figure 2 and Figure 3 (+X-axis direction). Additionally, mark 141 can be omitted.

[0074] like Figure 3 As shown in the lower half, the front end of the branch lumen 150Lb is connected to the wire lumen 150L. The base end of the branch lumen 150Lb is located closer to the base end of the shaft 110 than the front end. The base end of the branch lumen 150Lb communicates with the outside through a port 110e formed on the side surface of the shaft 110. In other words, an opening, i.e., port 110e, is provided in the shaft 110 at a position corresponding to the base end of the branch lumen 150Lb, to communicate with the outside. The branch lumen 150Lb extends away from the wire lumen 150L from the front end to the base end of the shaft 110.

[0075] The branch portion 150 has a large diameter portion 151, a raised portion 152, and a boundary wall 153. The large diameter portion 151 ( Figure 3 The lower half (dashed circle) is the part of the 150L wire tube with a relatively large inner diameter compared to the rest of the tube. For example... Figure 5 As shown, the inner diameter Φ151 of the lumen in the coarse diameter section 151 is larger than the inner diameter Φ150 of the wire lumen 150L. It should be noted that in the coarse diameter section 151, the inner diameter along the length of the approximately elliptical lumen is defined as "the inner diameter Φ151 of the lumen". Figure 5 In the diagram, for ease of explanation, the boundary wall 153, which is not shown on the CC section, is indicated by dashed lines.

[0076] like Figure 3As shown in the lower half, the raised portion 152 is a portion that protrudes from the inner circumferential surface 152i of the defined wire lumen 150L within the inner circumferential surface of the branch portion 150. The raised portion 152 is located in a region of the inner circumferential surface 152i of the branch portion 150 that is closer to the front end than the coarse diameter portion 151 and opposite to the extension side of the branch lumen 150Lb. In the raised portion 152, the inner circumferential surface 152i of the branch portion 150 protrudes towards the extension side of the branch lumen 150Lb. Figure 3 As shown in the lower half, the raised portion 152 of this embodiment has a shape that smoothly protrudes from the inner peripheral surface 152i of the branch portion 150. The length of the raised portion 152 in the longitudinal direction (X-axis direction) of the axis 110 can be arbitrarily determined.

[0077] The boundary wall 153 is a part of the shaft 110 located closer to the base end than the coarse diameter portion 151, and is the portion that separates the wire tube lumen 150L from the branch lumen 150Lb. For example... Figure 5 As shown, the boundary wall 153 in this embodiment is in the shape of a curved plate. However, as long as the wire tube cavity 150L and the branch tube cavity 150Lb are separated, the boundary wall 153 can be any shape such as plate or wing. Figure 3 As shown in the lower half, along the length direction (X-axis direction) of axis 110, the front end P1 of boundary wall 153 is located closer to the front end side than the front end P2 of port 110e. It should be noted that the front end P1 of boundary wall 153 may also be located at the same position as the front end P2 of port 110e. In this embodiment, "same" means approximately the same, allowing for differences due to manufacturing errors, etc. The length L153 of boundary wall 153 in the X-axis direction is greater than or equal to the length L110 of port 110e in the X-axis direction. Port 110e is inclined relative to the central axis O of axis 110. Therefore, as... Figure 3 As shown in the lower half, the length L110 of port 110e in the X-axis direction refers to the length when port 110e is projected onto the X-axis.

[0078] Figure 6 This diagram illustrates the action of the raised portion 152 in the first case. Figure 6 (A) shows the difference between and Figure 2 Side view of catheter 100 as viewed from the same direction. Figure 6 (B) shows the difference between Figure 3 A bottom view of the conduit 100 as observed from the same direction. It should be noted that... Figure 6In the diagram, the additional shaded dots indicate the delivery guide wire 70 as an example of a wire. The situation in which the delivery guide wire 70 is inserted into the wire lumen 150L from the front end first opening 110a and advanced from the front end side to the base end side inside the wire lumen 150L is referred to as the "first case". In other words, in the first case, the catheter 100 is used as a quick-exchange type (Rx type) catheter.

[0079] In the first scenario, the surgeon inserts the base of the guidewire 70 into the wire lumen 150L through the first opening 110a at the front end, and pulls it outward from the port 110e via the branch lumen 150Lb. At this time, as... Figure 6 As shown in (B), the base end of the delivery guide wire 70 is naturally guided outward from the port 110e located at the base end of the branch lumen 150Lb by contacting the raised portion 152 and naturally toward the side of the branch lumen 150Lb (in the direction of the thick arrow).

[0080] Figure 7 This diagram illustrates the action of boundary wall 153 in the second case. Figure 7 (A) shows the difference between and Figure 2 Side view of catheter 100 as viewed from the same direction. Figure 7 (B) shows the difference between Figure 3 A bottom view of the conduit 100 as observed from the same direction. It should be noted that... Figure 7 In the diagram, the additional shaded dots indicate a through-wire guidewire 400 as an example of a wire. The case where the through-wire guidewire 400 is inserted into the wire lumen 150L from the base opening 110c and advanced from the base side to the tip side inside the wire lumen 150L is referred to as the "second case." In other words, in the second case, the catheter 100 is used as an integral exchange type (OTW type) catheter.

[0081] In the second scenario, the surgeon inserts the tip of the through-wire guidewire 400 into the guidewire lumen 150L through the second opening 110b at the front end, and directly into the branch portion 150 (without accidentally inserting the through-wire guidewire 400 into the branch lumen 150Lb), then pulls it outward from the first incision portion 131 or the second incision portion 132. At this time, as... Figure 7 As shown in (B), the tip of the through-wire 400, through contact with the boundary wall 153, can be suppressed toward the branch lumen 150Lb, while naturally and directly entering the branch portion 150 (advancing in the direction of the thick arrow), reaching the portion where the first cut portion 131 or the second cut portion 132 is located.

[0082] return Figure 1Continuing with the explanation, the regulator 105 is an operating part used to move the imaging sensor 200 forward and backward within the sensor lumen 160L. The regulator 105 has a scale operable by the surgeon, which, by rotating the scale, moves the imaging sensor 200 inserted into the sensor lumen 160L forward or backward.

[0083] The outer shaft 114, the first inner shaft 115, the second inner shaft 116, the sealing component 111, and the regulator 105 can be formed of known materials such as nylon resin (e.g., polyamide); polyolefins (e.g., polyethylene, polypropylene, ethylene-propylene copolymer); polyesters (e.g., polyethylene terephthalate); thermoplastic resins (e.g., polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyurethane); polyamide elastomers, polyolefin elastomers, polyurethane elastomers, silicone rubber, latex rubber, etc. The outer shaft 114, the first inner shaft 115, the second inner shaft 116, the sealing component 111, and the regulator 105 can be formed of the same material, or at least partially or entirely of a material different from the other components. It should be noted that, for the outer shaft 114, the first inner shaft 115, the second inner shaft 116, and the sealing member 111, at least for the portion located near the incision portion 130 (first incision portion 131 and second incision portion 132), it is preferably formed of a resin with a small difference in acoustic impedance to biological tissue, for example, formed of polyethylene. This is because it will not hinder the ultrasound waves transmitted from the imaging sensor 200 to the biological tissue.

[0084] The tip 120 and the mark 141 can be formed from a flexible resin material, such as a polyurethane elastomer. The tip 120 and the mark 141 can also be formed from a radiopaque resin material or a metallic material. For example, if a radiopaque resin material is used, it can be formed by mixing radiopaque materials such as bismuth trioxide, tungsten, and barium sulfate into materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. If a radiopaque metallic material is used, it can be formed from gold, platinum, tungsten, or alloys containing these elements (e.g., platinum-nickel alloy). The tip 120 and the mark 141 can be formed from the same material or from different materials.

[0085] Figure 8This is a schematic diagram of the imaging sensor 200. The imaging sensor 200 has an elongated shape and is a "sensor" for acquiring information about biological tissue. The imaging sensor 200 includes a transducer 201, a drive cable 202, and a connector 203. The transducer 201 has an ultrasonic probe (also called an ultrasonic transducer, piezoelectric element, ultrasonic transceiver, or ultrasonic element) that transmits ultrasonic waves to the biological tissue and receives ultrasonic waves propagating and reflected within the tissue. The drive cable 202 has a coaxial line on its inner side that electrically connects the transducer 201 to a motor driver 204. The connector 203 connects the coaxial line of the cable 202 to the motor driver 204, which controls the rotation of the transducer 201. It should be noted that the motor driver 204 is electrically connected to the imaging control console 300 via a cable 50.

[0086] Figure 1 The imaging console 300 shown controls the imaging sensor 200, simultaneously generating and displaying images. Specifically, according to the operation of the regulator 105, the imaging console 300 moves the transducer 201 within the sensor cavity 160L along the length direction (X-axis direction) of the axis 110 and rotates it circumferentially (YZ-axis direction) along the axis 110. Furthermore, according to the operator's operation via an input unit (not shown), the imaging console 300 transmits ultrasound waves from the transducer 201 and causes the transducer 201 to receive reflected waves. The reflected waves received by the transducer 201 are transmitted to the imaging console 300 via the drive cable 202 and the cable 50. The imaging console 300 generates an image (two-dimensional image) with a grayscale corresponding to the intensity of the received reflected waves and displays the generated image on the display 302. Hereinafter, the image acquired by the imaging sensor 200 and displayed on the display 302 is also referred to as a "sensor image".

[0087] Figure 1 The illustrated permeable guidewire 400 is a long medical device with a pointed tip at its front end. The pointed tip is an arrow-shaped or wedge-shaped portion extending from the base towards the front end. In the permeable guidewire 400, the pointed tip at the front end allows it to penetrate biological tissue. The permeable guidewire 400 is equivalent to a "guidewire for penetrating biological tissue".

[0088] Figure 9 and Figure 10 This diagram illustrates the usage of the recanalization conduit system 1. Figure 9 and Figure 10The diagram illustrates, as an example of a biological lumen, a coronary artery 80, a CTO 81 formed within the coronary artery 80, a false lumen 82 (all the isolation lumens other than the true lumen formed by the guidewire 70) formed in or beneath the intima of the coronary artery 80, a true lumen 84, and a fibrous membrane or plaque 83 (hereinafter also referred to as "fibrous membrane 83") existing between the false lumen 82 and the true lumen 84. It should be noted that the fibrous membrane 83 may be fibrous on the surface of the CTO lesion.

[0089] Figure 9 (A) shows a case where the delivery guidewire 70 has been inserted into the coronary artery 80. Figure 9 In (A), the delivery guidewire 70 operated by the surgeon may accidentally enter the intima of the coronary artery 80, or form a false lumen 82 under the intima.

[0090] Figure 9 (B) illustrates the scenario where a delivery guidewire 70 is to be delivered within catheter 100. The surgeon performs... Figure 6 Following the instructions, insert the guidewire 70 into the catheter 100. (As described in the instructions...) Figure 6 As explained, in the catheter 100 of this embodiment, the base end of the delivery guidewire 70 is guided to the branch lumen 150Lb having the port 110e via the raised portion 152. Therefore, the base end of the delivery guidewire 70 can be easily pulled out from the port 110e to the outside. Furthermore, in the catheter 100 of this embodiment, the base end first opening 110c (on the base end side) guides the delivery guidewire 70... Figure 1 Compared to the existing method of pulling out the guidewire, the distance the guidewire 70 is delivered within the guidewire lumen 150L can be shortened. As a result, the time required to insert the guidewire 70 into the catheter 100 can be reduced. Thereafter, as... Figure 9 As shown in (B), the surgeon delivers the guidewire 70 along the catheter 100 and into the false lumen 82 within the catheter 100.

[0091] Figure 10 (A) shows the adjustment of the positions of the catheter 100 and the imaging sensor 200. The surgeon makes the adjustments according to the positions shown in a1 to a3 below. It should be noted that adjustment a2 can also be omitted.

[0092] (a1) The length direction of catheter 100 ( Figure 1Adjustment of position (in the X-axis direction). The surgeon moves the catheter 100 along the coronary artery 80 to position the first incision portion 131 and the second incision portion 132 of the catheter 100 in the optimal position, thereby allowing the through guidewire 400 to penetrate the true lumen 84. Adjustment a1 can be performed while confirming the position of the coronary artery 80 on the sensor image or the position of the marker 141 on the X-ray image.

[0093] (a2) Circumferential direction of catheter 100 ( Figure 1 Adjustment of the orientation in the YZ axis direction. The surgeon adjusts the catheter 100 to the orientation shown in the figure by rotating it circumferentially (i.e., the first incision portion 131 and the second incision portion 132 are located in the direction toward the CTO81). Adjustment a2 can be performed while confirming the positional relationship between the delivery guidewire 70 and the coronary artery 80 on the sensor image.

[0094] (a3) Regarding the length direction of the transducer 201 of the imaging sensor 200 ( Figure 1 The position of the transducer 201 (in the X-axis direction) is adjusted. The surgeon moves the transducer 201 by operating the adjuster 105 so that the transducer 201 is in a position suitable for observing the penetration of the guidewire 400. Adjustment a3 can be performed while confirming the coronary artery 80 on the sensor image.

[0095] Figure 10 (B) illustrates the case where the guidewire 400 penetrates biological tissue. First, the surgeon removes the guidewire 70. At this time, in the catheter 100 of this embodiment, the length of the guidewire 70 inserted into the wire lumen 150L is greater than that in… Figure 8 The existing situation described in (B) is shorter, so the delivery guide wire 70 can be pulled out more easily compared to the existing situation.

[0096] After removing the guidewire 70 mm, the surgeon performs... Figure 7 The procedure described herein involves inserting the guidewire 400 into the catheter 100. For example, in... Figure 7 As described above, in the catheter 100 of this embodiment, the boundary wall 153 prevents the tip of the through-wire guidewire 400 from accidentally entering the branch lumen 150Lb. Therefore, the tip of the through-wire guidewire 400 can be smoothly protruded from the first incision 131 or the second incision 132. Then, while confirming the tip of the through-wire guidewire 400 on the sensor image, the surgeon guides the tip of the through-wire guidewire 400 to the optimal penetration site. Then, the tip of the through-wire guidewire 400 is used to penetrate the biological tissue (target tissue), allowing the tip of the through-wire guidewire 400 to reach the true lumen 84.

[0097] This method enables the CTO 81 to be opened via the recanalization catheter system 1. It should be noted that the above method is merely an example, and the recanalization catheter system 1 can be used in various surgical procedures. For instance, the recanalization catheter system 1 is not limited to use in methods from the false lumen 82 to the true lumen 84, but can also be used in methods that traverse the CTO from the proximal true lumen 84 to the distal true lumen 84.

[0098] <Example 1 of the effect>

[0099] As described above, according to the catheter 100 of the first embodiment, since the shaft 110 has a wire lumen 150L and a sensor lumen 160L arranged side by side with the wire lumen 150L, ​​it is possible to perform surgery guided by an imaging sensor 200 (e.g., IVUS) inserted into the sensor lumen 160L, and it is possible to provide a catheter 100 that can perform surgery while changing different medical devices (e.g., delivery guidewire 70 and through guidewire 400) in the wire lumen 150L. Figure 9 , Figure 10 Furthermore, since a first opening 110a is formed at the front end of the protrusion 112, the guide wire 70 can be easily inserted into the wire tube 150L through the first opening 110a. Figure 6 (A)). Here, in the section where the first cutout 131 is formed, the shaft 110 has a bottom 1311 opposite to the first cutout 131 and a pair of sidewalls 1312 extending from the bottom 1311 toward the opposite side of the sensor cavity 160L. Figure 4 (B) Therefore, when the delivery guide wire 70 in the wire tube cavity 150L is pushed towards the base end, since the delivery guide wire 70 can be supported by the side wall 1312 provided in the section having the first cut 131, it is possible to prevent the delivery guide wire 70 from falling off and flying outwards from the shaft 110. Furthermore, since the first cut 131 is formed on the side surface of the shaft 110 on the side surface opposite to the sensor tube cavity 160L, it is possible to easily allow the through guide wire 400 to protrude outwards from the first cut 131. Figure 7 (A)). At this time, by utilizing the sidewall 1312 provided in the section having the first incision portion 131, the tip of the through guidewire 400 can be pushed outward, thus enabling the tip of the through guidewire 400 to protrude with high precision into the biological tissue (target tissue). As a result, the catheter 100 according to the first embodiment, which enables surgery to be performed under the guidance of the imaging sensor 200 and allows for the replacement of different medical devices while performing surgery, can achieve both a smaller diameter and improved ease of use.

[0100] Furthermore, according to the catheter 100 of the first embodiment, since the first incision portion 131 is elliptical in shape, the length L131a of the first minor axis of the first incision portion 131 is equal to the inner diameter Φ150 of the wire lumen 150L. Therefore, the first incision portion 131 can be provided over a wide circumferential range relative to the wire lumen 150L. Figure 3 Therefore, when the catheter 100 is inserted into the lumen of a living organism, even if the first incision portion 131 of the catheter 100 is separated from the biological tissue (target tissue) in the circumferential direction, the tip of the guidewire 400 can be easily directed toward the target tissue without rotating the catheter 100. Therefore, in the catheter 100 of the first embodiment, the aforementioned adjustment a2 can be omitted, for example.

[0101] Furthermore, according to the first embodiment of the conduit 100, a second incision 132 is formed on the side surface of the shaft 110 at a position closer to the front end or the base end than the first incision 131. Figure 2 , Figure 3 Therefore, the guide wire 400 can be selectively protruded outward from either the first cut portion 131 or the second cut portion 132. Furthermore, the shaft 110, in the section where the second cut portion 132 is formed, has a bottom opposite to the second cut portion 132 and a pair of sidewalls extending from the bottom towards the opposite side of the sensor lumen. Therefore, when the delivery guide wire 70 within the wire lumen 150L is advanced towards the base end, the delivery guide wire 70 is supported by the sidewalls provided in the section with the second cut portion 132, thus preventing the delivery guide wire 70 from falling off and flying outward from the shaft 110. Furthermore, by utilizing the sidewalls provided in the section with the second cut portion 132 to push the tip of the guide wire 400 outward, the tip of the guide wire 400 can be protruded with high precision into the biological tissue (target tissue).

[0102] Furthermore, according to the catheter 100 of the first embodiment, since the second incision portion 132 is elliptical in shape, and the length of the second minor axis L132a of the second incision portion 132 is equal to the inner diameter of the wire lumen 150L, ​​the second incision portion 132 can be provided over a wide circumferential range relative to the wire lumen 150L. Figure 3 Therefore, when the catheter 100 is inserted into the lumen of a living organism, even if the second incision portion 132 of the catheter 100 is separated from the biological tissue (target tissue) in the circumferential direction, the tip of the guidewire 400 can be easily directed toward the target tissue without rotating the catheter 100. Furthermore, since the length L132b of the second long axis of the second incision portion 132 is shorter than the length L131b of the first long axis of the first incision portion 131, the length of the second incision portion 132 in the length direction of the axis 110 can be made shorter than the length of the first incision portion 131. Figure 3 Therefore, in the second incision portion 132, compared to the first incision portion 131, it is easier to position the tip of the guidewire 400 relative to the target tissue. The surgeon can selectively use the first incision portion 131 and the second incision portion 132 according to the positional relationship between the catheter 100 and the target tissue, the size of the target tissue, etc., thus further improving the ease of use of the catheter 100.

[0103] <Example 2>

[0104] As described above, in the catheter 100 according to the first embodiment, since a first front opening 110a is formed at the front end of the protrusion 112 on the shaft 110, the guide wire 70 can be easily inserted into the wire lumen 150L through the first front opening 110a. Figure 6 (A)). Here, the branch lumen 150Lb branching from the wire lumen 150L communicates with the outside through a port 110e formed on the side surface of the shaft 110. Therefore, since the base end of the delivery guide wire 70 in the wire lumen 150L can be pulled out from the port 110e, the delivery guide wire 70 can be quickly inserted into the catheter 100. Figure 6 (A)). Furthermore, the branch portion 150 formed on the connection between the wire lumen 150L and the branch lumen 150Lb has a boundary wall 153 that separates the wire lumen 150L from the branch lumen 150Lb. Figure 5 Therefore, when the universal guide wire 400 is inserted into the wire lumen 150L from the base end side of the shaft 110 and advanced towards the front end side of the shaft 110, by bringing the front end of the universal guide wire 400 into contact with the boundary wall 153, it is possible to prevent the front end of the universal guide wire 400 from moving towards the branch lumen 150Lb. Figure 7 (B)). As a result, the catheter 100 according to the first embodiment can achieve both a smaller diameter and improved ease of use, in a catheter 100 that can perform surgery under the guidance of the imaging sensor 200 and can perform surgery while changing different medical devices.

[0105] Furthermore, according to the conduit 100 of the first embodiment, in the longitudinal direction of the shaft 110, the front end P1 of the boundary wall 153 is located at the same position as the front end position P2 of the port 110e, or at a position closer to the front end side than the front end position P2 of the port 110e. Figure 3 (the lower half of the shaft). Therefore, when the through guide wire 400 is inserted into the wire lumen 150L from the base end side of the shaft 110 and advanced towards the front end side of the shaft 110, the front end of the through guide wire 400 can be reliably prevented from moving toward the branch lumen 150Lb.

[0106] Furthermore, according to the conduit 100 of the first embodiment, the length L153 of the boundary wall 153 along the length direction of the axis 110 is greater than the length L110 of the port 110e along the length direction of the axis 110. Figure 3 (the lower half of the shaft). Therefore, when the through guide wire 400 is inserted into the wire lumen 150L from the base end side of the shaft 110 and advanced towards the front end side of the shaft 110, the front end of the through guide wire 400 can be reliably prevented from moving toward the branch lumen 150Lb.

[0107] Furthermore, according to the catheter 100 of the first embodiment, since the branch portion 150 also has a raised portion 152, the guide wire 70 can be guided through the raised portion 152. Specifically, in the first case where the guide wire 70 is inserted into the wire lumen 150L from the first opening 110a at the front end, the base end of the guide wire 70 is brought into contact with the raised portion 152 to guide the base end of the guide wire 70 toward the branch lumen 150Lb. Figure 6 (B)). In other words, in the first case where the catheter 100 is used as an Rx type, the bulge 152 guides the base end of the delivery guidewire 70 toward the branch lumen 150Lb with port 110e, thereby improving the ease of use of the Rx type catheter 100.

[0108] In the second case, where the guide wire 400 is inserted into the wire lumen 150L from the base end side of the shaft 110, the boundary wall 153 of the branch portion 150 prevents the front end of the guide wire 400 from moving towards the branch lumen 150Lb by contacting the boundary wall 153. Figure 7 B). In other words, in the second case where the catheter 100 is used as an OTW type, the boundary wall 153 guides the tip of the through guidewire 400 toward the front end of the wire lumen 150L, ​​thereby improving the ease of use of the OTW type catheter 100. As described above, since the wire lumen 150L of the catheter 100 in the first embodiment can be shared by different medical devices (delivery guidewire 70, through guidewire 400), the catheter 100 can be made smaller in diameter.

[0109] <Second Implementation>

[0110] Figure 11 This is an explanatory diagram illustrating the structure of a portion of the tip side of the catheter 100A according to the second embodiment. The recanalization catheter system 1 of the second embodiment includes... Figure 11 The catheter 100A shown is an alternative to the catheter 100 described in the first embodiment. The shaft 110A of the catheter 100A includes a cut-out portion 130A, which is an alternative to the cut-out portion 130. The cut-out portion 130A does not have the second cut-out portion 132 described in the first embodiment, but only has a single first cut-out portion 131.

[0111] Thus, the structure of the incision portion 130A can be modified in various ways, and the incision portion 130A can be constituted by only a single first incision portion 131. In this case, the mark 141 can be positioned closer to the front end than the first incision portion 131, or it can be positioned closer to the base end than the first incision portion 131. The catheter 100A of the second embodiment described above can also achieve the same effect as the first embodiment described above.

[0112] <Third Implementation Method>

[0113] Figure 12 This is an explanatory diagram illustrating the structure of a portion of the tip side of the catheter 100B according to the third embodiment. The recanalization catheter system 1 of the third embodiment includes... Figure 12 The catheter 100B shown is used in place of the catheter 100 described in the first embodiment. The shaft 110B of the catheter 100B includes a cut-out portion 130B in place of the cut-out portion 130. In addition to the first cut-out portion 131 and the second cut-out portion 132 described in the first embodiment, the cut-out portion 130B also includes a third cut-out 133.

[0114] The third cut 133 is located closer to the front end than the second cut 132. The third cut 133 is formed on the side surface of the shaft 110B on the same side as the first cut 131. When viewed from the wire lumen 150L side, the third cut 133 is an elliptical shape with a major axis and a minor axis. The length of the minor axis of the third cut 133 is equal to the inner diameter Φ150 of the wire lumen 150L. The length L133b of the major axis of the third cut 133 is shorter than the length L131b of the first major axis of the first cut 131, and shorter than the length L132b of the second major axis of the second cut 132. In the section where the third cut 133 is formed, the shaft 110B has a bottom opposite to the third cut 133 and a pair of sidewalls extending from the bottom towards the opposite side of the sensor lumen 160L.

[0115] Furthermore, a second mark 142 is joined on the outer peripheral surface of the shaft 100 between the second cut 132 and the third cut 133. The second mark 142 is a semi-circular component provided along the outer peripheral surface of the shaft 110B. The second mark 142 is the same as the mark 141 described in the first embodiment, and can be colored to improve visual recognition, or it can be formed of a material that is non-radiotransmissive.

[0116] Thus, the structure of the incision portion 130B can be modified in various ways, and it can be composed of three or more incision portions (first incision portion 131, second incision portion 132, and third incision portion 133). Furthermore, the third incision portion 133 can be positioned closer to the base end than the first incision portion 131. The catheter 100B of the third embodiment described above can also achieve the same effects as the first embodiment described above.

[0117] <Fourth Implementation>

[0118] Figure 13 This is an explanatory diagram illustrating the structure of a portion of the front end side of the catheter 100C according to the fourth embodiment. Figure 13 Indicates from and Figure 3 A bottom view of catheter 100C viewed from the same direction. The recanalization catheter system 1 of the fourth embodiment includes... Figure 13 The catheter 100C shown is an alternative to the catheter 100 described in the first embodiment. The shaft 110C of the catheter 100C has a branch 150C, which is an alternative to the branch 150. The branch 150C does not have the ridge 152 and boundary wall 153 described in the first embodiment.

[0119] Thus, the structure of the branch 150C can be modified in various ways, and it may have at least one of the raised portion 152 and the boundary wall 153, or neither. The conduit 100C of the fourth embodiment described above, in addition to guiding the filament in the first and second cases, can also achieve the same effect as the first embodiment described above.

[0120] <Fifth Implementation>

[0121] Figure 14 This is an explanatory diagram illustrating the cross-sectional structure of the catheter 100D according to the fifth embodiment. Figure 14 The upper part shows along Figure 2 A cross-sectional view taken along line B2-B2. Figure 14 The lower half of the diagram shows an explanatory figure regarding the range of the first incision portion 131D. The recanalization catheter system 1 of the fourth embodiment includes... Figure 14 The catheter 100D shown is used in place of the catheter 100 described in the first embodiment. The shaft 110D of the catheter 100D has a first incision 131D, which is used in place of the first incision 131 described in the first embodiment.

[0122] The first cut 131D is formed on the same side as the first cut 131 described in the first embodiment, and is an elliptical shape having a first minor axis and a first major axis. On the other hand, the angle occupied by the first cut 131 in the first embodiment around the entire circumference of the wire tube 150L is approximately 180 degrees, while the angle θ occupied by the first cut 131D in this embodiment around the entire circumference of the wire tube 150L is approximately 240 degrees. Figure 14 (the lower half). Therefore, the sidewall 1312D of the first cut portion 131D is shorter than the sidewall 1312 described in the first embodiment. In addition, the length L131a of the first minor axis of the first cut portion 131D is shorter than the inner diameter Φ150 of the wire tube lumen 150L.

[0123] Thus, the structure of the first incision portion 131D can be modified in various ways, and the angle θ occupied by the first incision portion 131D around the entire circumference of the wire lumen 150L can be arbitrarily changed. Similarly, the angle occupied by the second incision portion 132 around the entire circumference of the wire lumen 150L can also be arbitrarily changed. The catheter 100D of the fifth embodiment described above can also achieve the same effect as the first embodiment described above.

[0124] <Sixth Implementation Method>

[0125] Figure 15 This is an explanatory diagram illustrating the cross-sectional structure of the catheter 100E according to the sixth embodiment. Figure 15 It shows along Figure 2 The cross-sectional structure cut along line B1-B1. The re-opening conduit system 1 of the sixth embodiment includes... Figure 15 The catheter 100E shown is an alternative to the catheter 100 described in the first embodiment. The shaft 110E of the catheter 100E does not have the outer shaft 114, first inner shaft 115, second inner shaft 116, and sealing member 111 described in the first embodiment; instead, it is composed of a single shaft 110E. The shaft 110E has the same structure as the shaft 110 described in the first embodiment, except that it is composed of a single component. That is, the shaft 110E has the wire lumen 150L, ​​sensor lumen 160L, protrusion 112, slit 130, and branch 150 described in the first embodiment.

[0126] Thus, the structure of the catheter 100E can be modified in various ways, and it can be composed of a single shaft 110E. Alternatively, the shaft 110E may not have an outer shaft 114 and a sealing member 111, but instead has a structure where a first inner shaft 115 and a second inner shaft 116 are joined. Furthermore, the shaft 110E may not have a sealing member 111, but instead has a structure where the first inner shaft 115 and the second inner shaft 116 are housed inside the outer shaft 114. The catheter 100E of the sixth embodiment described above can also achieve the same effects as the first embodiment described above.

[0127] <Seventh Implementation>

[0128] Figure 16 This is an explanatory diagram illustrating the cross-sectional structure of the catheter 100F according to the seventh embodiment. Figure 16 Show along Figure 2 The cross-sectional structure cut by the CC line. The re-opening conduit system 1 of the seventh embodiment includes... Figure 16 The catheter 100F shown is an alternative to the catheter 100 described in the first embodiment. In the shaft 110F of the catheter 100F, the wire lumen 150L and the branch lumen 150Lb are arranged at an angle relative to the Z-axis direction.

[0129] Thus, the structure of shaft 110F can be modified in various ways, and the configuration of the wire lumen 150L, ​​branch lumen 150Lb, and sensor lumen 160L inside shaft 110F can be arbitrarily changed. The conduit 100F of the seventh embodiment described above can also achieve the same effect as the first embodiment described above.

[0130] <Eighth Implementation Method>

[0131] Figure 17 This is an explanatory diagram illustrating the structure of a portion of the front end side of the catheter 100G according to the eighth embodiment. Figure 17 (A) shows a side view of catheter 100G. Figure 17 (B) shows a bottom view of catheter 100G. The recanalization catheter system 1 of the eighth embodiment includes... Figure 17 The catheter 100G shown is used in place of the catheter 100 described in the first embodiment.

[0132] The shaft 110G of the catheter 100G has a wire lumen 150LG, replacing the wire lumen 150L described in the first embodiment. The wire lumen 150LG does not branch, but extends linearly from the front end to the base end of the shaft 110G. Therefore, the shaft 110G does not have the branch lumen 150Lb, port 110e, branch portion 150, large diameter portion 151, ridge portion 152, and boundary wall 153 described in the first embodiment. In the catheter 100G of this embodiment, the guidewire 70 is inserted into the wire lumen 150LG from the front end first opening 110a. In the first case where the guidewire 70 travels from the front end side to the base end side inside the wire lumen 150LG, the base end of the guidewire 70 is pulled out from the base end first opening 110c of the shaft 110G.

[0133] Thus, the structure of shaft 110G can be modified in various ways, and it can also have a non-branched wire lumen 150LG. The conduit 100G of the eighth embodiment described above can also achieve the same effect as that described in Effect Example 1 of the effects described in the first embodiment above.

[0134] <Ninth Implementation Method>

[0135] Figure 18 This is an explanatory diagram illustrating the structure of a portion of the front end side of the catheter 100H according to the ninth embodiment. Figure 18 (A) shows a side view of catheter 100H. Figure 18 (B) shows a bottom view of catheter 100H. The recanalization catheter system 1 of the ninth embodiment includes Figure 18 The catheter 100H shown is used in place of the catheter 100 described in the first embodiment.

[0136] The shaft 110H of the catheter 100H does not have the incision portion 130 (first incision portion 131, second incision portion 132) described in the first embodiment. According to the catheter 100H of this embodiment, in the second case where the guidewire 400 is inserted into the wire lumen 150L from the base end first opening 110c inside the wire lumen 150L from the base end side to the front end side, the front end of the guidewire 400 protrudes from the front end first opening 110a of the shaft 110H.

[0137] Thus, the structure of shaft 110H can be modified in various ways, and it may not have the cutout 130. The conduit 100H of the ninth embodiment described above can also achieve the same effect as that described in effect example 2 of the first embodiment.

[0138] <Modifications of this embodiment>

[0139] The present invention is not limited to the above-described embodiments, and can be implemented in various ways without departing from its spirit, for example, by the following modifications.

[0140] [Variation Example 1]

[0141] In the first to ninth embodiments described above, an example of the structure of the recanalization catheter system 1 was shown. However, the structure of the recanalization catheter system 1 can be modified in various ways. For example, instead of the imaging sensor 200, a sensor that acquires images of biological tissue can be used by other units besides transmitting and receiving ultrasound waves. Alternatively, instead of the imaging sensor 200, an OCT (Optical Coherence Tomography) or a camera can be inserted to acquire images of biological tissue within the blood vessel.

[0142] For example, the recanalization catheter system 1 can also be configured as a system that does not use a penetrating guidewire 400, but uses a plasma guidewire to achieve CTO recanalization, which utilizes plasma to ablate biological tissue. In this case, in catheters 100, 100A to 100H, it is preferable to provide an electrode at the front end of shaft 110. In this way, by outputting high-frequency power between the electrode at the front end of shaft 110 and the front electrode of plasma guidewire, energy can be released by the discharge between the two electrodes, thereby enabling the ablation of biological tissue. It should be noted that the electrode at the front end of shaft 110 is preferably positioned closer to the base side than the tip 120 and closer to the front end side than the incision portion 130.

[0143] For example, the recanalization catheter system 1 can also be used for other methods not described above. For example, the recanalization catheter system can be used in vessels other than the coronary arteries (e.g., cerebral vessels), or within the lumen of an organism outside of a blood vessel. For example, the recanalization catheter system 1 can also be used for treatments or examinations other than recanalization of CTO.

[0144] [Variation Example 2]

[0145] In the first to ninth embodiments described above, an example of the structure of catheters 100, 100A to 100H is shown. However, the structure of catheters 100, 100A to 100H can be modified in various ways. For example, the wire lumen 150L and the sensor lumen 160L of catheter 100 can be set to approximately the same diameter, or the wire lumen 150L can be configured to be smaller than the sensor lumen 160L. For example, in addition to the wire lumen 150L and the sensor lumen 160L, catheter 100 may also have additional lumens for use with other medical devices, or for simultaneous insertion of the delivery guidewire 70 and the through guidewire 400.

[0146] For example, the front end P1 of boundary wall 153 ( Figure 3 The lower half of the boundary wall 153 can also be located closer to the base end than the front end P2 of port 110e. For example, the length L153 of the boundary wall 153 along the length direction of axis 110. Figure 3 The lower half of the shaft 110e may also be smaller than the length L110 of the port 110e along the length direction of the shaft 110. For example, at least one of the outer surfaces of the shafts 110, 110A to 110H, the outer or inner surface of the first inner shaft 115, the outer or inner surface of the second inner shaft 116, and the outer or inner surface of the outer shaft 114 may be coated with any resin layer (e.g., a hydrophilic resin layer, a hydrophobic resin layer, a base layer for improving the bonding of the hydrophilic or hydrophobic resin layer, etc.), or an agent may be applied to the surface.

[0147] [Variation Example 3]

[0148] The structures of catheters 100, 100A to 100H in the first to ninth embodiments, as well as the structures of catheters 100, 100A to 100H in the modified examples 1 and 2, can be appropriately combined. For example, in catheter 100G described in the eighth embodiment, the structures described in the second, third, fourth, and seventh embodiments can be used. For example, in catheter 100H described in the ninth embodiment, the structure described in the fourth embodiment can be used. For example, in catheters 100A and 100B described in the second or third embodiment, the structures described in the fifth and seventh embodiments can be used. For example, in catheters 100A to 100D and 100F to 100H described in the second to fifth embodiments and the seventh to ninth embodiments, the structure described in the sixth embodiment can be used.

[0149] As described above, the present invention has been illustrated based on embodiments and variations. However, the embodiments described above are merely examples to facilitate understanding of the present invention and are not intended to limit the present invention. All variations, modifications, and equivalent substitutions made within the spirit of the present invention and the scope of the claims should be included within the protection scope of the present invention. Furthermore, technical features not described as indispensable in this specification may be appropriately omitted.

[0150] Explanation of reference numerals in the attached figures

[0151] 1…Reopen the duct system

[0152] 50… cable

[0153] 70… delivery guide wire

[0154] 100, 100A~100H…catheter

[0155] 105… Regulator

[0156] 110, 110A~110H… shafts

[0157] 110a…First opening at the front end

[0158] 110b…Second opening at the front

[0159] 110c…basement first opening

[0160] 110d…Second opening at the base

[0161] 110e…port

[0162] 111…Sealing component

[0163] 112…protrusion

[0164] 114…Outer shaft

[0165] 115…First Inner Axis

[0166] 116…Second Inner Shaft

[0167] 120…tip

[0168] 130, 130A, 130B... Incision area

[0169] 131, 131D… First incision

[0170] 132…Second incision

[0171] 133… Third incision

[0172] 141…marked

[0173] 142…Second Mark

[0174] 150, 150C... Branch

[0175] 150L, ​​150LG… Wire tubing

[0176] 150Lb……Branch lumen

[0177] 151…Rough Diameter Section

[0178] 152…protrusion

[0179] 1521…inner circumference

[0180] 153…Boundary wall

[0181] 160L…sensor cavity

[0182] 200…imaging sensor

[0183] 201…Transducer

[0184] 202…Drive cable

[0185] 203… connector

[0186] 204…motor driver

[0187] 300… Imaging Control Console

[0188] 302… Monitor

[0189] 400…Penetrating guidewire

[0190] 1311…bottom

[0191] 1312, 1312D…sidewall

Claims

1. A catheter having a shaft; The shaft has: A wire tube extending along the length of the axis; A sensor cavity, wherein the sensor cavity is arranged side by side with the wire cavity; The protrusion includes the wire lumen and protrudes further towards the front end than the front end of the sensor lumen, and a front opening communicating with the wire lumen is formed at the front end of the protrusion. as well as The first cut is a cut that is formed at a position closer to the base end than the protrusion and communicates with the lumen of the filament tube. in, The first cut is formed on the side surface of the shaft, on the side surface opposite to the sensor cavity with reference to the central axis of the wire cavity; In the section where the first cut is formed, the shaft has a bottom opposite to the first cut and a pair of sidewalls extending from the bottom toward the opposite side of the sensor lumen. The shaft also includes: A branch lumen that branches off from the wire lumen between the front end and the base end of the shaft; as well as A branch portion, the branch portion being formed at the connection between the wire tube lumen and the branch tube lumen; Regarding the branch lumen, The front end of the branch tube is connected to the wire tube. The base end of the branch lumen is located closer to the base end of the shaft than the front end; The base end of the branch lumen is connected to the outside through a port formed on the side surface of the shaft; The branch has: The coarse diameter section has an inner diameter that is larger than the inner diameter of the lumen of other parts of the wire lumen. as well as A boundary wall, located closer to the base end than the coarse diameter portion, separates the wire lumen from the branch lumen. The branch portion also has a raised portion, which is formed by a region on the inner circumferential surface of the wire lumen that is closer to the front end than the coarse diameter portion and opposite to the extension side of the branch lumen, rising toward the extension side of the branch lumen.

2. The catheter according to claim 1, wherein, The shaft also includes: The second incision is formed at a position closer to the front end or base end than the first incision and communicates with the lumen of the wire tube. The second cut is formed on the same side surface as the first cut in the side surface of the shaft; selectively, the through guide wire protrudes outward from either the first cut or the second cut.

3. The catheter according to claim 1, wherein, The shaft also includes: The second incision is formed at a position closer to the front end or base end than the first incision and communicates with the lumen of the wire tube. in, The second cut is formed on the side surface of the shaft on the same side as the first cut; In the section where the second cut is formed, the shaft has a bottom opposite to the second cut and a pair of sidewalls extending from the bottom toward the opposite side of the sensor lumen. Both the first cut and the second cut are located closer to the front end than the port formed on the side surface of the shaft.

4. The catheter according to claim 2 or 3, wherein, When viewing the shaft from the side of the wire tube cavity. The first cut is elliptical in shape, having a first major axis extending along the central axis of the filament tube and a first minor axis extending perpendicular to the central axis; the length of the first minor axis is equal to the inner diameter of the filament tube. The second cut is elliptical in shape, and the elliptical shape has a second major axis extending along the central axis of the filament tube and a second minor axis extending perpendicular to the central axis; The length of the second short axis is equal to the inner diameter of the wire tube, and the length of the second long axis is shorter than the length of the first long axis of the first cut portion.

5. The catheter according to claim 1, wherein, The port is inclined relative to the central axis of the shaft; Along the length of the axis, the front end of the boundary wall is located at the same position as the front end of the port, or at a position closer to the front end than the front end of the port.

6. The catheter according to claim 1, wherein, The length of the boundary wall along the axis is greater than or equal to the length of the port along the axis.

7. The catheter according to claim 5, wherein, The length of the boundary wall along the axis is greater than or equal to the length of the port along the axis.

8. The catheter according to claim 1, wherein, In the first case where the filament is inserted into the filament tube from the front opening, the base end of the filament is guided toward the branch tube by contacting the raised portion. In the second case where the filament is inserted into the filament tube from the base end side of the shaft, the front end of the filament is made to contact the boundary wall to prevent the front end of the filament from moving toward the branch tube.

Images