Device for passing through constricted section in biological organ

Abstract

This device 1b for passing through a constricted section in a biological organ according to the present invention comprises: an outer tube 2c comprising a distal end opening 23, a lumen 11, a balloon 22 provided at the outer surface of a distal end section, and a balloon lumen 28; and an inner tube 3b that can be inserted into the lumen 11 and has a guide wire lumen 51. The inner tube 3b comprises a distal end section that can protrude from the distal end opening 23 of the outer tube 2c, and a constriction insertion section 52 that is provided at the distal end section and can enter a constricted section in a biological organ. The outer tube 2c comprises: a deformable section 21c that is positioned closer to the distal end side than the balloon and can change the orientation of the distal end opening 23; and a manipulation section 30 for manipulating the orientation of the distal end opening 23 in the deformable section.

Description

Device for penetrating a stenosis in a living organ

[0001] The present invention relates to a device for penetrating a stenosis in a living organ for improving the stenosis of a living lumen.

[0002] As an example of a case where a stenosis is formed in a living lumen, there is, for example, deep vein thrombosis. In deep vein thrombosis, rapid improvement of the stenosis formed in the blood vessel is necessary. As such a device for improving the stenosis, for example, the access catheter of JP-T-2023-507553 (Patent Document 1) has been proposed. In the access catheter of Patent Document 1, it has a guide rail with a cannula extending therethrough, and a forward segment of the rail that extends at least about 10 cm beyond the distal end of the access catheter. The access catheter and the rail can advance on the guide wire until the distal end of the forward segment reaches the target blood vessel site. Thereafter, the access catheter can advance to the target blood vessel site along the rail, and the rail is removed leaving the access catheter to provide access to the target blood vessel site. The thrombus removal catheter can be extended through the access catheter, and the thrombus engagement tool can be advanced through the thrombus removal catheter.

[0003] Further, although it is not used for acute lower limb ischemia or deep vein thrombosis, the applicant of the present application has proposed the catheter of Patent Document 2 (Japanese Patent Publication No. 05-58338). The catheter of Patent Document 2 includes a catheter body having a convex portion at the tip, and a catheter sheath that can insert the catheter, and the tip is an end for an intravascular occlusion or stenosis causative substance or intima resection, and has an inner diameter substantially equal to the outer diameter including the convex portion of the catheter body.

[0004] Special Table 2023-507553 (WO2021-127004, USP11065018) Japanese Patent Publication No. 05-58338

[0005] While Patent Documents 1 and 2 can improve stenosis formed within biological organs, in both Patent Documents 1 and 2, if the vein affected by deep vein thrombosis was curved or tortuous, it was not easy to quickly reach the target stenosis with the device used for improvement.

[0006] The object of the present invention is to provide a device for penetrating stenosis within a living organ that can quickly reach the target stenosis area, even when the vein affected by deep vein thrombosis is curved or tortuous.

[0007] The following device achieves the above objective: A device for penetrating a constricted area in a biological organ, comprising: an outer tube having a tip opening, a lumen communicating with the tip opening, a balloon provided on the outer surface of the tip, and a balloon lumen communicating with the inside of the balloon; and an inner tube that can be inserted into the lumen of the outer tube and has a guide wire lumen, wherein the inner tube has a tip portion that can protrude from the tip opening of the outer tube and a constriction insertion portion provided at the tip that can enter a constricted area in a biological organ; and the outer tube has a deformable portion located on the tip side of the balloon and capable of changing the orientation of the tip opening, and an operating portion for operating the orientation of the tip opening in the deformable portion.

[0008] Figure 1 is a partially abbreviated plan view of a device penetrating a constricted area within a biological organ according to an embodiment of the present invention. Figure 2 is a bottom view of the device penetrating a constricted area within a biological organ shown in Figure 1. Figure 3 is a front view of the device penetrating a constricted area within a biological organ shown in Figure 1. Figure 4 is a partially abbreviated enlarged plan view of the outer tube used in the device penetrating a constricted area within a biological organ shown in Figure 1. Figure 5 is a partially abbreviated enlarged plan view of the inner tube used in the device penetrating a constricted area within a biological organ shown in Figure 1. Figure 6 is a longitudinal cross-sectional view of the inner tube shown in Figure 5. Figure 7 is an enlarged longitudinal cross-sectional view of the tip of the outer tube used in the device penetrating a constricted area within a biological organ shown in Figure 1. Figure 8 is a cross-sectional view taken along line A-A in Figure 7. Figure 9 is a cross-sectional view taken along line B-B in Figure 7. Figure 10 is a cross-sectional view taken along line C-C in Figure 7. Figure 11 is an enlarged front view of the tip of the reinforcing body provided on the outer tube of the device penetrating a constricted area within a biological organ shown in Figure 1. Figure 12 is an enlarged front view of the tip of the reinforcing body of another embodiment provided on the outer tube of the device penetrating a constricted area within a biological organ according to the present invention. Figure 13 is a longitudinal cross-sectional view of the tip of the reinforcing body shown in Figure 12. Figure 14 is an enlarged front view of the tip of the reinforcing body of another embodiment provided on the outer tube of the biological organ constriction penetration device of the present invention. Figure 15 is an enlarged longitudinal cross-sectional view of the base end of the outer tube used in the biological organ constriction penetration device shown in Figure 1. Figure 16 is an enlarged cross-sectional view of a partially broken section of the base end of the outer tube used in the biological organ constriction penetration device shown in Figure 3. Figure 17 is an enlarged cross-sectional view of a partially broken section of the base end of the outer tube of another embodiment used in the biological organ constriction penetration device of the present invention. Figure 18 is an enlarged plan view of the outer tube of another embodiment used in the biological organ constriction penetration device of the present invention, with some parts omitted. Figure 19 is an enlarged front view of the biological organ constriction penetration device of another embodiment, with some parts omitted. Figure 20 is an enlarged front view of the inner tube used in the biological organ constriction penetration device shown in Figure 19, with some parts omitted. Figure 21 is an enlarged front view of the biological organ constriction penetration device shown in Figure 20, with some parts omitted, in a pushed-in state. Figure 22 is a partially fractured, enlarged cross-sectional view of the proximal end of the intraorganic constriction penetration device in the state shown in Figure 21. Figure 23 is an explanatory diagram illustrating the operation of the intraorganic constriction penetration device of the present invention. Figure 24 is an explanatory diagram illustrating the operation of the intraorganic constriction penetration device of the present invention.Figure 25 is an explanatory diagram illustrating the operation of the device for penetrating a constricted area within a biological organ according to the present invention. Figure 26 is an explanatory diagram illustrating the operation of the device for penetrating a constricted area within a biological organ according to the present invention. Figure 27 is an explanatory diagram illustrating the operation of the device for penetrating a constricted area within a biological organ according to the present invention. Figure 28 is an explanatory diagram illustrating the operation of the device for penetrating a constricted area within a biological organ according to the present invention. Figure 29 is an explanatory diagram illustrating the operation of the device for penetrating a constricted area within a biological organ according to the present invention. Figure 30 is an explanatory diagram illustrating the operation of the device for penetrating a constricted area within a biological organ according to the present invention. Figure 31 is an explanatory diagram illustrating the operation of the device for penetrating a constricted area within a biological organ according to the present invention. Figure 32 is a partially omitted plan view of a device for penetrating a constricted area within a biological organ according to another embodiment of the present invention. Figure 33 is a partially omitted enlarged plan view of the inner tube used in the device for penetrating a constricted area within a biological organ shown in Figure 32. Figure 34 is an enlarged longitudinal cross-sectional view of the tip portion of the inner tube shown in Figure 33. Figure 35 is an enlarged view of the tip surface of the inner tube shown in Figure 33. Figure 36 is an explanatory diagram illustrating the cross-sectional shape along the line D-D in Figure 35. Figure 37 is an enlarged longitudinal cross-sectional view of the tip portion of the outer tube used in the intra-organ stenosis penetration device shown in Figure 32. Figure 38 is a cross-sectional view taken along line E-E in Figure 37. Figure 39 is a cross-sectional view taken along line F-F in Figure 37. Figure 40 is a cross-sectional view taken along line G-G in Figure 37. Figure 41 is a cross-sectional view taken along line H-H in Figure 37. Figure 42 is an explanatory diagram illustrating the operation of the intra-organ stenosis penetration device shown in Figure 32. Figure 43 is an explanatory diagram illustrating the operation of the intra-organ stenosis penetration device shown in Figure 32.

[0009] The present invention will be described using an embodiment shown in the drawings for a device that penetrates a constricted area within a biological organ. The present invention comprises an outer tube 2 having a tip opening 23, a lumen 11 communicating with the tip opening 23, a balloon 22 provided on the outer surface of the tip, and a balloon lumen 28 communicating with the inside of the balloon 22, and an inner tube 3 that can be inserted into the lumen 11 of the outer tube 2 and has a guide wire lumen 51. The inner tube 3 has a tip portion that can protrude from the tip opening 23 of the outer tube 2 and a constriction insertion portion 52 provided at the tip that can enter a constricted area within a biological organ. The outer tube 2 has a deformable portion 21 located on the tip side of the balloon 22 that can change the orientation of the tip opening 23, and an operating portion 30 that operates the orientation of the tip opening 23 in the deformable portion 21.

[0010] As shown in Figures 1 to 3, the intra-organ stenosis penetration device 1 of this embodiment comprises an outer tube 2 and an inner tube 3 that can be inserted into the lumen 11 of the outer tube 2. As shown in Figures 1 to 4, the outer tube 2 comprises a tip opening 23, a lumen 11 communicating with the tip opening 23, a balloon 22 provided on the outer surface of the tip, a balloon lumen 28 communicating with the inside of the balloon 22, a deformable portion 21 located on the tip side of the balloon 22 and capable of changing the orientation of the tip opening 23, and an operating portion 30 for operating the orientation of the tip opening 23 in the deformable portion 21.

[0011] Furthermore, as shown in Figures 1, 7 to 10, the outer tube 2 comprises an outer tube body 20 having an inner layer 41, a reinforcing body 43 covering the outer surface of the inner layer 41, and an outer layer 42 covering the reinforcing body 43, and an operating part 30 attached to the rear end of the outer tube body 20.

[0012] Furthermore, as shown in Figures 8 and 16, a balloon lumen 28 is formed inside the wall of the outer tube body 20. The balloon lumen 28 communicates with the interior 22a of the balloon 22 at one end opening 28a, and communicates with the balloon expansion fluid port 35 at the other end opening 28b.

[0013] As shown in Figure 7, the outer tube 2 has one end fixed to the tip or near the tip opening 23 of the deformable portion 21 of the outer tube 2, and the other end is equipped with a first traction wire 24 that extends outward from the rear end of the outer tube 2. The orientation of the tip opening 23 in the deformable portion 21 can be changed by pulling the first traction wire 24.

[0014] In particular, in this embodiment, as shown in Figure 7, the outer tube 2 includes a first traction wire 24, one end of which is fixed to the tip or near the tip opening 23 of the deformable portion 21 of the outer tube 2, and the other end of which extends outward from the rear end of the outer tube 2; and a second traction wire 25, one end of which is fixed to the tip or near the tip opening 23 of the deformable portion 21 of the outer tube 2 and opposite to the first traction wire 24, and the other end of which extends outward from the rear end of the outer tube 2. By selectively tractioning the first traction wire 24 and the second traction wire 25, the orientation of the tip opening 23 in the deformable portion 21 can be changed to different directions.

[0015] As shown in Figures 7 and 8, the deformable portion 21 at the tip of the outer tube 2 is a thin-walled portion 42a where the outer layer is thinned, and an annular void portion 44 is formed inside the thin-walled portion 42a. In addition, the reinforcing body 43 (the tip of the annular reinforcing body 43) located in the deformable portion 21 is an easily deformable portion. In this embodiment, as shown in Figure 11, it is provided with a spiral slot 48 which is a slit of a certain width. The reinforcing body 43 has an annular body 45 at its tip, and the tip of the first traction wire 24 is fixed to this annular body 45 by a fixing portion 45a. Similarly, the tip of the second traction wire 25 is fixed to the annular body 45 by a fixing portion 45b. In addition, the portions of the first traction wire 24 and the second traction wire 25 located within the annular void portion 44 are not fixed to the reinforcing body 43, inner layer 42, or outer layer 41, except for the tips. The outer tube 2 has a good deformable portion 21 due to this structure.

[0016] Furthermore, as shown in the embodiment of Figure 18, the outer tube 2a may have a recess 21b on the outer or inner surface of the tip portion 21 of the outer tube body 20a, which is on the tip side of the balloon 22, in this embodiment, on the outer surface of the outer layer. By forming a recess at the tip of the outer tube body 21 as in this embodiment, deformation of the tip portion of the outer tube 2, specifically, changing the orientation of the tip opening 23 of the outer tube 2, becomes easier. The position of the recess 21b is preferably on the tip side of the tip portion 21. Furthermore, the recess 21b is preferably one having a plurality of annular recesses as shown, or preferably a spiral recess.

[0017] Furthermore, as shown in Figures 7 and 15, the outer tube 2 is equipped with a first traction wire insertion lumen 46 and a second traction wire insertion lumen 47 provided within the wall. The first traction wire 24 is inserted through the first traction wire insertion lumen 46, and the second traction wire 25 is inserted through the second traction wire insertion lumen 47. As shown in Figures 1, 2, 4, and 15, the rear end of the first traction wire 24 extends outward from the first traction wire port 33, and a gripping portion 24a is provided at its rear end. Similarly, the rear end of the second traction wire 25 extends outward from the second traction wire port 34, and a gripping portion 25a is provided at its rear end.

[0018] Furthermore, in this embodiment, as shown in Figures 7 and 8, a tip 21a is provided at the tip of the outer tube 2, and the inner surface of the tip 21a widens towards the tip, forming a sharp annular tip. In addition, in this embodiment, the annular body 45 at the tip of the reinforcing body 43, the tips of the first traction wire 24 and the second traction wire 25 fixed to the annular body 45, the tip of the reinforcing body 43, and the tip of the inner layer 41 are fixed to the tip 21a.

[0019] As shown in Figures 1, 2, and 7, the first towing wire 24 and the second towing wire 25 are arranged to face each other. Specifically, the lumen 46 for inserting the first towing wire and the lumen 47 for inserting the second towing wire are formed to face each other. Specifically, the tips of the first towing wire 24 and the tips of the second towing wire 25 are fixed to the annular tip 45 of the reinforcing body 43 so as to face each other with respect to the central axis of the outer tube 2 (outer tube body 20). In addition, the first towing wire port 33 and the second towing wire port 34 are also arranged to face each other.

[0020] Then, by pulling the first towing wire 24 at the rear end, the tip of the first towing wire 24 deforms by moving slightly towards the base end, and the tip opening 23 of the outer tube 2 faces diagonally upward in Figure 7. Also, by pulling the second towing wire 25 at the rear end, the tip of the second towing wire 25 deforms by moving slightly towards the base end, and the tip opening 23 of the outer tube 2 faces diagonally downward in Figure 7.

[0021] The balloon 22 is fitted onto the outer surface of the outer tube body 20 (the outer surface of the outer layer 42) so as to cover one end opening 28a of the balloon lumen 28 of the outer tube body 20. The balloon 22 is made of a material that can be expanded and contracted. Such materials can be, for example, silicone rubber, butyl rubber, isoprene rubber, or resin-based elastomers (e.g., polyolefin-based elastomers, styrene-based elastomers). The inner surfaces of both ends of the balloon 22 are sealed and fixed to the outer surface of the outer layer 42 in a liquid-tight manner by adhesive or heat fusion.

[0022] Next, the operating section 30 of the outer tube 2 of the intravascular organ stenosis penetration device 1 of this embodiment will be described with reference to Figures 1 to 4, 15 and 16. The operating section 30 of this embodiment includes an outer tube hub 31 fixed to the rear end of the outer tube body 20. The outer tube hub 31 includes a cylindrical portion extending for a predetermined length, and a balloon expansion fluid port 35, a first traction wire port 33, and a second traction wire port 34 that protrude diagonally rearward from the side surface of the outer tube hub 31 (cylindrical portion). The first traction wire port 33 and the second traction wire port 34 are arranged to face each other. In the operating section 30 of this embodiment, as shown in Figure 15, the outer tube body 20 has a communication hole at its rear end that connects to the first traction wire port 33 and the second traction wire port 34. Furthermore, as shown in Figure 16, the outer tube body 20 is provided with an opening 28b at the other end of the balloon lumen 28, and the balloon lumen 28 and the balloon expansion fluid port 35 are in communication through this other end opening 28b.

[0023] The balloon expansion fluid port 35 is fitted with a liquid injection device connecting member 32. In this embodiment, the liquid injection device connecting member 32 comprises a connecting tube 36 with one end fixed to the balloon expansion fluid port 35, and a stopcock 37 connected to the other end of the connecting tube 36. In this embodiment, a three-way stopcock is used as the stopcock 37, and comprises a flow path switching cock 39, injection device connecting ports 38a and 38b, and a connection part 38c to the connecting tube 36.

[0024] Furthermore, as shown in Figures 15 and 16, the rear end of the outer tube hub 31 is provided with a screwable ring-shaped member 65 and an elastic ring-shaped sealing member 66 that can be deformed by pressure between the internal annular projection 31a of the outer tube hub 31 and the ring-shaped member 65. As a result, when the screwing of the ring-shaped member 65 progresses, the ring-shaped sealing member 66 is pressed between the internal annular projection 31a of the outer tube hub 31 and the ring-shaped member 65, and its inner diameter is reduced. This allows the inserted inner tube 3 to be held and its movement to be restricted. An elastic material is preferred for the ring-shaped sealing member 66. As the material for forming the elastic member, rubber such as silicone rubber, butyl rubber, and isoprene rubber, or resin-based elastomers (e.g., polyolefin-based elastomers, styrene-based elastomers) can be used. The cross-section of the ring-shaped sealing member 66 can be a circular shape, known as an O-ring, or an X-shaped cross-section. An X-shaped sealing member, known as an X-ring, can ensure the sliding properties of a component inserted inside while maintaining liquid-tightness.

[0025] Furthermore, as for the operating section, as shown in Figure 17, the outer tube hub 31b fixed to the rear end of the outer tube body 20 may have a cylindrical portion extending for a predetermined length, a balloon expansion fluid port 35 protruding diagonally rearward from the side surface of the outer tube hub 31b (cylindrical portion), a first traction wire port 33, a second traction wire port 34, and a suction port 62 communicating with the lumen 11 of the outer tube body 20. In this embodiment, the operating section 30a has a communication hole 63 at its rear end for the suction port 62. By connecting a suction means (e.g., a suction pump, syringe, etc.) to the suction port 62 provided in the outer tube hub, liquids and solids that have entered the outer tube 2 can be aspirated and removed.

[0026] When a device for penetrating stenotic regions within a living organ is used for deep vein thrombosis, the outer diameter of the outer tube 2 is preferably 4 to 20 mm, and more preferably 8 to 15 mm. Furthermore, when a device for penetrating stenotic regions within a living organ is used for deep vein thrombosis, the length of the outer tube body 20 is preferably 500 to 1200 mm, and more preferably 700 to 1000 mm.

[0027] The materials used to form the inner layer 41 and outer layer 42 of the outer tube body 20 are preferably those with a certain degree of flexibility. For example, thermoplastic resins such as polyethylene, polypropylene, ethylene-propylene copolymer, polyolefin elastomer, ethylene-vinyl acetate copolymer, polyamide elastomer, and polyurethane can be used. Furthermore, X-ray opaque substances (for example, barium sulfate, bismuth subcarbonate, tungsten powder, etc.) may be mixed into the materials forming the inner layer 41 and outer layer 42.

[0028] The reinforcing body 43 covering the outer surface of the inner layer 41 is preferably an elastic metal tube, such as stainless steel (SUS304, SUS316, etc.) or a superelastic metal tube. Furthermore, the reinforcing body 43 may have a spiral slit along part of its length or the entire length from the easily deformable tip to the rear end. The spiral slot 48 and the slit described above can be formed from a metal tube by laser processing (e.g., YAG laser), electrical discharge machining, chemical etching, cutting, etc.

[0029] Furthermore, as shown in Figure 11, the helical slot 48 described above has a starting end located at the tip of the reinforcing body 43 and an ending end located at the rear end for a predetermined length. The width of the helical slot 48 is preferably 0.05 to 3.0 mm, and particularly preferably 0.1 to 2.0 mm.

[0030] Furthermore, the shape of the easily deformable portion at the tip of the reinforcing body 43 is not limited to the spiral slots described later. For example, as shown in Figures 12 and 13, the easily deformable portion may have a plurality of annular slots perpendicular to the central axis of the reinforcing body 43a and having a start end and an end end. In the reinforcing body 43a of this embodiment, the easily deformable portion has a plurality of arc-shaped slots 48a having a start end and an end end, and adjacent arc-shaped slots 48a do not have overlapping non-slot portions between the start end and the end end in the axial direction.

[0031] In particular, in the reinforcing body 43a of this embodiment, arc-shaped slots 48a are formed opposite each other at the same axial position of the reinforcing body 43a, with a length that does not reach half the circumference of the reinforcing body 43a. Therefore, opposite non-slotted portions are formed between the opposite arc-shaped slots 48a. Similarly, next to the arc-shaped slots 48a, another arc-shaped slot 48a is formed at the same axial position of the reinforcing body 43a, with a length that does not reach half the circumference of the reinforcing body 43a. Similarly, opposite non-slotted portions are formed between the opposite arc-shaped slots 48a.

[0032] Furthermore, the arc-shaped slots 48a are offset by approximately 90 degrees with respect to the central axis of the housing. As a result, the non-slit portions between opposing arc-shaped slots 48a and the opposing non-slit portions are not adjacent in the axial direction of the housing. The size of the arc of each arc-shaped slot 48a is slightly larger than 1 / 4 of the circumference. The distance between adjacent arc-shaped slots 48a is approximately the same. While it is preferable for the arc-shaped slots 48a to be a combination of opposing slits as described above, they may also consist of a single arc-shaped slot 48a that is slightly larger than 1 / 2 of the circumference.

[0033] Furthermore, the shape of the easily deformable portion at the tip of the reinforcing body may be as shown in Figure 14. The easily deformable portion of the reinforcing body 43b in this embodiment comprises a number of ring portions provided parallel to the axial direction of the reinforcing body 43b and slightly spaced apart, and connecting portions that connect adjacent ring portions, and adjacent connecting portions in the axial direction are continuous in the axial direction. A semicircular slot 48b is formed between adjacent ring portions. The semicircular slot 48b is perpendicular to the central axis of the reinforcing body 43b and has a start end and an end end. The traction wires 24 and 25 are fixed to the ring portions located at the tip by fixing portions 45a and 45b, and the fixing portions 45a and 45b are fixed to portions of the ring portions that are spaced apart from the connecting portions that connect adjacent ring portions, specifically, portions of the ring portions that are offset by approximately 90 degrees with respect to the central axis of the reinforcing body 43b from the connecting portions that connect adjacent ring portions. Therefore, the easily deformable portion of the reinforcing body 43b can be easily deformed by the pulling of the towing wires 24 and 25.

[0034] Furthermore, the reinforcing body 43 may be a wire-wrapped reinforcing body formed by winding wire around the outer surface of the inner layer 41. The wire-wrapped reinforcing body is preferably made of thin wires made of metal wire wound around the outer surface of the inner layer in a mesh-like or spiral pattern. In particular, the wire-wrapped reinforcing body is preferably made of a mesh-like braid (blade) woven together from thin wires. Specifically, it is preferable that the braid is formed by the intersection of a plurality of thin wires wound in a first spiral direction at intervals from each other in the axial direction of the inner layer and a plurality of thin wires wound in a second spiral direction different from the first spiral direction at intervals from each other in the axial direction of the inner layer.

[0035] Suitable wires for forming the wire-wrapped reinforcement are metal wires, such as stainless steel wires, amorphous alloy wires, platinum, gold, tungsten, tantalum, iridium, and other X-ray-enhancing metal wires.

[0036] Next, the inner tube 3 will be described using Figures 1 to 3, 5 and 6. As shown in Figures 1 to 3, the inner tube 3 has a tip portion that can be inserted into the lumen 11 of the outer tube 2 and can protrude from the tip opening 23 of the outer tube 2, and a stenosis insertion portion 52 provided at the tip portion that can enter a constricted area inside a living organ.

[0037] The inner tube 3 comprises an inner tube body 50, a constricted insertion portion 52 provided at the tip of the inner tube body 50, and an inner tube hub 53 provided at the rear end of the inner tube body 50. The inner tube 3 is equipped with a guide wire lumen 51 that extends from the tip to the rear end.

[0038] The stenosis insertion portion 52 is equipped with a position-holding outer surface portion 54 that, when inserted into a stenosis within a biological organ, allows the stenosis insertion portion 52 to maintain its position through contact with the inside of the stenosis within the biological organ. In this embodiment, the position-holding outer surface portion 54 is formed by a helical groove provided on the outer surface of the tip of the stenosis insertion portion 52. Note that instead of a helical groove, there may be multiple annular grooves. Also, in this embodiment, the stenosis insertion portion 52 tapers towards its tip 51a.

[0039] Specifically, in this embodiment, the rear end of the portion where the position-holding outer surface portion 54 is formed is a large-diameter portion, and the front end is a tapered portion that decreases in diameter towards the tip. Furthermore, the portion behind the rear end of the large-diameter portion is a tapered portion that decreases in diameter towards the rear.

[0040] In this embodiment, the position-holding outer surface portion 54 is provided with one or more helical grooves, and the position-holding outer surface portion 54, through its outer diameter shape and helical grooves, enables the position of the stenosis insertion portion 52 by contact with the inside of the stenosis within the biological organ.

[0041] Furthermore, the tip of the inner tube 3 having the constricted insertion portion 52 may be formed from a separate material from the inner tube body 50 and attached to the tip of the inner tube body 50. For example, a hollow tip member having the constricted insertion portion 52 may be formed, and the tip of the inner tube body 50 may be inserted into its rear end and fixed in place, or a hollow tip member having the constricted insertion portion 52 may be formed, and its rear end may be fixed to the tip of the inner tube body. In this case, when the hollow tip member having the constricted insertion portion 52 is formed from a separate material from the inner tube body, the tip member may be made of a material with higher hardness than the inner tube body.

[0042] Furthermore, it is preferable that the inner tube 3, by rotational force applied at its rear end, allows its tip, which has a constriction insertion portion 52, to enter the constriction within a biological organ. For this reason, the inner tube 3 in this embodiment is equipped with a reinforcing body 56. It is preferable that the reinforcing body 56 is located on the inner surface or outside the inner surface of the inner tube body 50. The tip of the reinforcing body 56 reaches the tip of the inner tube body 50, and its rear end extends to the rear end of the inner tube body 50. By providing such a reinforcing body 56, the torque generated when the inner tube 3 is rotated inside the outer tube 2 can be efficiently transmitted to the constriction insertion portion 52. In addition, the reinforcing body 56 can preferably be the same as the reinforcing body 43 described above.

[0043] The outer diameter of the constricted insertion portion 52 is approximately the same as or slightly smaller than the diameter of the lumen 11 of the outer tube body 20. The inner tube 3 has a total length such that at least the entire constricted insertion portion 52 can protrude beyond the tip of the outer tube 2. An inner tube hub 53 is fixed to the base end of the inner tube body 50, and the inner tube hub 53 has a guide wire insertion port 51b and a gripping portion (anti-slip) 55 for rotational operation.

[0044] Incidentally, the outer surface portion 54 for position holding of the narrow insertion portion 52 is not limited to the spiral groove as described above. The outer surface portion 54 for position holding may be a tip portion having an outer diameter as described above and having a plurality of annular grooves inclined with respect to the central axis of the inner tube main body 50, a tip portion having an outer diameter as described above and having a spiral rib inclined with respect to the central axis of the inner tube main body 50, a tip portion having an outer diameter as described above and having a plurality of disk-shaped ribs inclined with respect to the central axis of the inner tube main body 50, and the like.

[0045] As the material for forming the inner tube main body 50, a material having hardness and flexibility is preferable. For example, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, resins such as PEEK (polyether ether ketone) and polyimide can be preferably used. Further, the tip portion (narrow insertion portion 52) of the inner tube main body 50 may be harder than the resin forming the other portion of the inner tube main body 50. In particular, the outer surface of the tip portion (narrow insertion portion 52) of the inner tube main body 50 is preferably hard.

[0046] Next, the living body organ internal stenosis penetrating device 1a of the embodiment shown in FIGS. 19 to 22 will be described. The basic structure of the living body organ internal stenosis penetrating device 1a of this embodiment is the same as that of the living body organ internal stenosis penetrating device 1 of the above-described embodiment. The difference is only in the form of the inner tube 3a. As shown in FIGS. 19 to 22, the living body organ internal stenosis penetrating device 1a of this embodiment includes an outer tube 2b and an inner tube 3a that can be inserted into the inner cavity 11 of the outer tube 2b. The outer tube 2b includes a tip opening 23, an inner cavity 11 communicating with the tip opening 23, a balloon 22 provided on the outer surface of the tip portion, a balloon lumen 28 communicating with the inside of the balloon 22, a deformable portion 21 located on the tip side of the balloon 22 and capable of changing the direction of the tip opening 23, and an operation portion 30b for operating the direction of the tip opening 23 in the deformable portion 21.

[0047] As shown in FIG. 21, the inner tube 3a includes a tip portion that can protrude from the tip opening 23 of the outer tube 2b, and a constricted insertion portion 52 that can enter a constricted portion within a living organ provided at the tip portion. Specifically, the inner tube 3a includes an inner tube body 50a having a guide wire lumen 51, and spiral fins 61 provided on the outer surface of the inner tube body 50a and extending from the tip portion of the inner tube body 50a toward the rear end portion. The tip portion of the spiral fins 61 forms an outer surface for position holding. An inner tube hub 53a is fixed to the end of the inner tube body 50a, and the inner tube hub 53a has a guide wire insertion port and a gripping portion (anti-slip) 55 during rotation operation. A covering tube 57 is provided at the base end portion of the inner tube body 50a. The base end of the spiral fins 61 extends to near the tip portion of the covering tube 57. The inner tube 3a is rotatable within the outer tube 2b.

[0048] As shown in FIG. 22, the outer tube 2b includes a port 62 that communicates with the inside of the outer tube 2b at the rear end portion of the outer tube hub 31c of the outer tube 2b. In the operation portion 30b of this embodiment, the rear end portion of the outer tube body 20 has a communication hole 63 with the suction port 62. As shown in FIG. 20, the spiral fins 61 of the inner tube 3a of this embodiment include a large-diameter portion 61a provided at a position on the rear end side of a predetermined length from the tip of the inner tube 3a, specifically, at the tip portion of the inner tube 3a. The spiral fins 61 on the tip side of the large-diameter portion 61a are reduced in diameter toward the tip.

[0049] Also, the spiral fins 61 on the rear side of the large-diameter portion 61a are smaller in diameter than the large-diameter portion. The outer diameter of the large-diameter portion 61a is substantially the same as or slightly smaller than the diameter of the inner cavity of the outer tube body 20. The inner tube 3a has a total length such that at least a certain portion of the constricted insertion portion 52 can protrude from the tip of the outer tube 2b. Specifically, as shown in FIG. 21, which is an enlarged front view of a partially omitted state where the inner tube 3a of the living organ inner constriction penetrating device 1a shown in FIG. 19 is pushed in, the entire constricted insertion portion 52 of the inner tube 3a can protrude from the tip of the outer tube 2b.

[0050] In this embodiment of the intra-organ stenosis penetration device 1a, after inserting the stenosis insertion portion 52 (spiral fin 61) of the inner tube 3a into the stenosis within the intraorgan, the stenosis-forming material taken into the spiral fin can be moved to the rear of the inner tube 3a by rotating the inner tube 3a. Then, by connecting a suction means (e.g., suction pump, syringe, etc.) to the suction port 62 provided on the outer tube hub 31c, the stenosis-forming material, as well as any liquid or solid matter (atheroma, thrombus, etc.) that has entered the outer tube can be aspirated and removed.

[0051] Furthermore, as shown in Figure 22, the internal organ stenosis penetration device 1a of this embodiment also includes a screwable ring-shaped member 65 at the rear end of the outer tube hub 31c, and an elastic ring-shaped sealing member 66 that can be deformed by pressure between the internal annular projection 31a of the outer tube hub 31c and the ring-shaped member 65. Therefore, as the screwing of the ring-shaped member 65 progresses, the ring-shaped sealing member 66 is pressed between the internal annular projection 31a of the outer tube hub 31c and the ring-shaped member 65, causing its inner diameter to shrink. This allows the inserted inner tube 3a (specifically, the covering tube 57) to be held and its movement to be restricted. An elastic member is preferred as the ring-shaped sealing member 66. As the material for forming the elastic member, rubbers such as silicone rubber, butyl rubber, and isoprene rubber, or resin-based elastomers (for example, polyolefin-based elastomers, styrene-based elastomers) can be used. The cross-section of the ring-shaped sealing member 66 includes not only a circular shape, commonly known as an O-ring, but also those with an X-shaped cross-section. The ring-shaped sealing member with an X-shaped cross-section can ensure the sliding properties of the member inserted inside while maintaining liquid tightness.

[0052] Furthermore, as shown in Figure 22, even when the inner tube 3a is pushed in, the inner tube 3a (specifically, the covering tube 57) does not obstruct the outflow of substance from the communication hole 63 of the suction port 62 provided at the rear end of the outer tube body. In addition, since the rear end of the spiral fin 61 extends to the communication hole 63 of the suction port 62, the moving material that has moved toward the rear end of the outer tube body due to the rotation of the inner tube 3a can be guided to the communication hole 63 of the suction port 62. As a result, the moving material can be effectively sucked and removed using the suction port 62.

[0053] The inner tube 3a can be provided with means to confirm two states: the state in which the inner tube 3a is retracted and the stenosis insertion portion 52 is housed in the lumen 11 of the outer tube 2b, as shown in Figure 19, and the state in which the inner tube 3a is pushed in and the stenosis insertion portion 52 protrudes from the outer tube 2b, as shown in Figure 22. Possible means for this include arranging circumferential protrusions on the covering tube 57 so that the hand holding the inner tube hub 51 can feel (apply a slight vibration) when the circumferential protrusions enter and exit the outer tube hub, or providing visible markers on the surface of the covering tube 57 at intervals corresponding to the two states above, allowing for visual confirmation. Such means make it possible to confirm the position of the stenosis insertion portion 52 of the inner tube 3a even when it is difficult to directly confirm with an X-ray image. Furthermore, such means make it possible to prevent the covering tube 57 of the inner tube 3a from being pulled out too far, causing it to deviate from the sealing member, and to prevent the communication hole of the suction port from being blocked due to being pushed in too far.

[0054] Next, the operation of the biological organ stenosis penetration device 1 of the present invention will be explained using Figures 23 to 31. As shown in Figure 23, a guide wire 80 is inserted through the inner tube 3. The biological organ stenosis penetration device 1, with its tip protruding, is inserted into a biological organ having a stenosis 71 (for example, a vein 70 that has developed deep vein thrombosis). Then, as shown in Figure 23, the tip of the device 1 is positioned near the stenosis 71, and the tip of the guide wire 80 is inserted into the stenosis 71.

[0055] Next, as shown in Figure 24, the balloon 22 is inflated at the position shown in Figure 23 to fix the device 1 inside the vein 70 having the stenosis 71. Then, as shown in Figure 25, the inner tube 3 is rotated and advanced together with the guide wire 80 to insert the stenosis insertion portion 52 of the inner tube 3 into the stenosis 71. The position-holding outer surface of the stenosis insertion portion 52 of the inner tube comes into contact with the inside of the stenosis. In the state shown in Figure 25, the position of the stenosis insertion portion 52, in other words, the tip of the inner tube 3, is held away from the stenosis by the contact between the position-holding outer surface and the inside of the stenosis.

[0056] Next, as shown in Figure 26, after deflating the balloon 22, the inner tube hub of the inner tube 3 is held with one hand, and the outer tube hub of the outer tube 2 is pushed forward with the other hand, causing the tip 21 of the outer tube 2 to enter the stenosis 71. As a result, the stenosis insertion section 52 and the guide wire 80 are drawn into the lumen of the outer tube 2. The tip of the device 1 (the tip of the outer tube 2) then reaches near one end of the bend in the stenosis 71 of the vein 70. Subsequently, by pulling one of the traction wires of the device 1, the orientation of the tip opening of the outer tube 2 is changed, as shown in Figure 27.

[0057] Then, as shown in Figure 28, the balloon 22 is expanded and the outer tube 2 is fixed to the vein 70. The inner tube 3 is then rotated and advanced together with the guide wire 80 to further advance the stenosis insertion portion 52 of the inner tube 3 into the stenosis 71. Even in the state shown in Figure 28, the position of the stenosis insertion portion 52, or in other words, the tip of the inner tube 3, is held in place from the stenosis by contact between the position-holding outer surface and the inside of the stenosis.

[0058] Next, after deflating the balloon 22, the outer tube 2 is advanced, and the tip (deformable portion) 21 of the outer tube 2 is advanced through the bend of the stenosis 71, so that the tip of the device 1 reaches just before the other end of the bend in the stenosis 71 of the vein 70. In this state, as shown in Figure 29, the balloon 22 is inflated again to fix the device 1 inside the stenosis 71. Then, if necessary, the orientation of the tip opening of the outer tube 2 is changed by pulling a different traction wire than the one previously used to pull the device 1, and the inner tube 3 is advanced together with the guide wire 80 while rotating, so that the stenosis insertion portion 52 of the inner tube 3 advances further inside the stenosis 71.

[0059] As a result, as shown in Figure 30, the tip of the constricted insertion portion 52 of the inner tube 3 protrudes from the other end of the constricted portion 71. Then, as shown in Figure 31, after the balloon 22 is deflated, the outer tube 2 is advanced, causing the tip 21 of the outer tube 2 to protrude from the other end of the constricted portion 71. As a result, the device 1 penetrates the constricted portion.

[0060] After reaching the state shown in Figure 31, the inner tube 3 can be removed, and an instrument for removing the constricted portion 71 can be inserted through the lumen 11 of the outer tube 2. Alternatively, the outer tube 2 and inner tube 3 can be withdrawn, leaving the guide wire 80 in place, and the instrument for removing the constricted portion 71 can be inserted through the guide wire 80.

[0061] In the above-described embodiment, the rotation of the inner tube can be performed manually, but it is also possible to mechanically control the on / off switching and rotation speed by connecting a drive device that generates rotational force to the inner tube hub.

[0062] In the embodiments described above, the deformable portion whose direction of the tip opening can be changed was described as being pulled by a pull wire, but it is not limited to this. For example, a heat-deformable member may be placed in the deformable portion, and an electric wire connected to the member may be passed through the wall thickness of the outer tube and current may be supplied to the electric wire from the hand, causing the member to heat up and the deformable portion to deform. Also, in the embodiments described above, the direction of the deformable portion was changed by a pair of pull wires, but the direction of the deformable portion may be changed by a single pull wire.

[0063] In the embodiments described above, the inner tube was described as having a guide wire lumen, but it may also be a solid, elongated cylindrical body without a guide wire lumen. In that case, the inner tube should be read as an elongated cylindrical member.

[0064] Next, the biological organ stenosis penetration device 1b of the embodiment shown in Figures 32 to 41 will be described. The basic structure of the biological organ stenosis penetration device 1b of this embodiment is the same as that of the biological organ stenosis penetration device 1 of the embodiment described above. The differences are the shape of the inner tube 3b and the shape of the tip portion of the outer tube 2c. In Figures 32 to 41, the parts that are denoted by the same reference numerals as those of the biological organ stenosis penetration device 1 described above are the same as those of the biological organ stenosis penetration device 1 described above.

[0065] The organ stenosis penetration device 1b in this embodiment comprises an outer tube 2c having a tip opening 23 and a lumen 11 communicating with the tip opening 23, and an inner tube 3b that can be inserted into the lumen 11 of the outer tube 2c. The inner tube 3b comprises a tip portion 82 that can protrude from the tip opening 23 of the outer tube 2c, and a stenosis insertion portion provided on the tip portion 82 that can enter the organ stenosis. The outer tube 2c comprises a deformable portion 21c located at the tip that can change the orientation of the tip opening 23, an operating portion 30 that operates the orientation of the tip opening 23 in the deformable portion 21c, and a first traction wire 24 and a second traction wire 25, one end of which is fixed to the tip portion of the deformable portion 21c or near the tip opening 23 of the outer tube 2c.

[0066] In this embodiment of the intra-organ stenosis penetration device 1b, when the orientation of the tip opening 23 at the deformable portion 21c of the outer tube 2c is changed by pulling the same predetermined length of the first traction wire 24 and the second traction wire 25, the radius of curvature of the deformable portion 21c (tip of the intra-organ stenosis penetration device 1b) due to the pulling of the first traction wire 24 is different from the radius of curvature of the deformable portion 21c (tip of the intra-organ stenosis penetration device 1b) due to the pulling of the second traction wire 25.

[0067] In other words, the radius of curvature of the deformable portion 21c when the orientation of the tip opening 23 is changed by a predetermined length of traction operation of the first traction wire 24 in the intravascular organ stenosis penetrating device 1b is different from the radius of curvature of the deformable portion 21c when the orientation of the tip opening 23 is changed by the same predetermined length of traction operation of the second traction wire 25 as that of the first traction wire 24.

[0068] The intravascular stenosis penetration device 1b in this embodiment has a deformable portion 21c, in other words, the tip of the intravascular stenosis penetration device 1b, which can be bent at different radii of curvature. Therefore, it can be used not only to accommodate curves in blood vessels with large radii of curvature, but also to curves in blood vessels with small radii of curvature. It can then be advanced through blood vessels with these curves. Furthermore, the tip that is curved with a small radius of curvature can be directed towards emboli near the inner wall of the blood vessel, making it highly maneuverable. This makes it easy to insert the stenosis insertion portion of the tip 82 of the inner tube 3b into the intravascular stenosis (intravascular stenosis). By further advancing the stenosis insertion portion, it is possible to improve the stenotic state of the intravascular stenosis (intravascular stenosis). Furthermore, if the stenosis insertion portion provided at the tip 82 of the inner tube 3b has a cutting function, it can cut the embolic material in the intravascular stenosis (stenosis in a living organ), and the inner tube 3b can also be used to aspirate the cut material using its lumen 83, thereby achieving a good improvement in the stenosis in the living organ.

[0069] Furthermore, in the biological organ stenosis penetration device 1b of this embodiment, the outer tube 2c includes a first traction wire insertion lumen 46 provided within the wall of the outer tube 2c, a second traction wire insertion lumen 47 provided within the wall of the outer tube 2c, a first traction wire protrusion opening 26 whose one end is located near the tip or tip opening 23 of the deformable portion 21c of the outer tube 2c, extends toward the rear end of the outer tube 2c, and allows the first traction wire 24 to protrude from the side surface of the outer tube 2c when the first traction wire 24 is being pulled, and a second traction wire protrusion opening 27 whose one end is located near the tip or tip opening 23 of the deformable portion 21c of the outer tube 2c, extends toward the rear end of the outer tube 2c, and allows the second traction wire 25 to protrude from the side surface of the outer tube 2c when the second traction wire 25 is being pulled.

[0070] The rear end of the second traction wire protrusion opening 27 is located on the rear end side of the outer tube 2c, relative to the first traction wire protrusion opening 26. The maximum protrusion length of the second traction wire 25 from the second traction wire protrusion opening 27 is longer than the maximum protrusion length of the first traction wire 24 from the first traction wire protrusion opening 26.

[0071] Furthermore, as shown in Figures 32 to 41, the intravascular organ stenosis penetration device 1b of this embodiment comprises an outer tube 2c having a tip opening 23, a lumen 11 communicating with the tip opening 23, a balloon 22 provided on the outer surface of the tip, and a balloon lumen 28 communicating with the inside of the balloon 22, and an inner tube 3b that can be inserted into the lumen 11 of the outer tube 2c.

[0072] The inner tube 3b will be explained using Figures 32 to 36. As shown in Figures 33 and 34, the inner tube 3b has a tip portion 82 that can be inserted into the lumen 11 of the outer tube 2c and can protrude from the tip opening 23 of the outer tube 2c. The tip portion 82 is a stenosis insertion portion that can enter a narrowed area within a living organ. The inner tube body 81 is a tubular body having a hollow, hemispherical tip portion 82. Because the tip portion 82 is hemispherical, it can prevent damage to the inner wall of a blood vessel even if it comes into contact with it.

[0073] The inner tube 3b comprises an inner tube body 81, a covering portion 86 provided in a liquid-tight manner on the outer surface of the inner tube body 81, and an inner tube hub 53 provided at the rear end of the inner tube body 81. The inner tube 3b has an internal lumen 83. The covering portion 86 may be provided in a liquid-tight manner on the inner surface of the inner tube body 81.

[0074] In this embodiment, the narrowed insertion portion of the inner tube 3b is formed by providing a spiral opening 84 in the hollow hemispherical tip portion 82. Specifically, in this embodiment, as shown in Figures 32 to 35, a plurality of spiral openings 84 are provided at equal intervals with respect to the central axis of the inner tube 3b. The spiral opening 84 may be a single spiral. In the case of a single spiral, it is preferable that it has its starting point in the center of the tip portion 82 and extends spirally toward the rear end. The spiral opening 84 is also used as an opening to aspirate the cut embolus.

[0075] In this embodiment, as shown in Figure 35, the spiral opening 84 has its starting point at the center of the tip portion 82 and extends towards the rear end of the tip portion 82 while curving. The spiral opening 84 terminates slightly towards the tip from the rear end of the hollow hemispherical tip portion 82 (the tip of the tubular body portion of the inner tube body 81). Therefore, the spiral opening 84 does not reach the tubular body portion of the inner tube body 81. In addition, the width of the spiral opening 84 gradually widens towards the rear end. The width of the spiral opening 84 may be approximately the same from the center to the rear end. In this embodiment, as shown in Figure 35, all of the multiple spiral openings 84 have the same shape. The multiple spiral openings 84 are provided at equal intervals with respect to the central axis of the inner tube 3b. The number of multiple spiral openings 84 is preferably 4 to 10, and particularly preferably 5 to 8.

[0076] The multiple spiral openings 84 do not have to be the same shape. For example, they may be arranged in alternating patterns of wide and narrow spiral openings, alternating patterns of long and short spiral openings, or arrangements of multiple spiral openings, each with a different shape.

[0077] The spiral opening 84 preferably has a blade portion 85 on its outer surface. Figure 36 is an explanatory diagram for illustrating the cross-sectional shape in the section of line D-D in Figure 35. In this embodiment, the upper edge of the outer surface of the spiral opening 84 is the blade portion 85. The blade portion 85 is provided on both sides of the spiral opening 84. The blade portion 85 may be on only one side. In this case, it is preferable that the blade portion 85 is provided on the upper edge of the outer surface that is outside the spiral.

[0078] Furthermore, in this embodiment, as shown in Figure 36, the inner portion of the spiral opening 84 narrows in width towards the opening of the spiral opening 84. Also, the upper edge of the outer surface of the spiral opening 84 is thinner and has a sharper edge (blade portion 85) compared to other parts. This enables good cutting of the constricted portion. It is preferable that the inner tube 3b is such that the tip portion 82 having the constriction insertion portion can enter the constricted portion inside the biological organ by the rotational force applied at the rear end. For this reason, it is preferable that the inner tube 3b in this embodiment has a certain degree of flexibility and efficiently transmits the torque when the inner tube 3b is rotated inside the outer tube 2c to the tip portion 82 having the constriction insertion portion.

[0079] In this embodiment, as shown in Figures 33 and 34, the inner tube 3b is provided with a plurality of arc-shaped slots 87 in the tubular body portion of the inner tube body 81. Therefore, the inner tube 3b is flexible. The arc-shaped slots 87 have a start end and an end end. Also, the arc-shaped slots 87 are not connected but are independent of each other. The forming portion of the arc-shaped slots 87 extends a predetermined length from the tip end of the tubular body portion of the inner tube body 81 toward the rear end. Preferably, the forming portion of the arc-shaped slots 87 extends from the tip end of the tubular body portion of the inner tube body 81 to the rear end or to the rear end.

[0080] In this embodiment, in the inner tube 3b, adjacent arc-shaped slots 87 in the axial direction are such that the non-slotted portions between the start and end points do not overlap in the axial direction. Specifically, in the inner tube 3b of this embodiment, two arc-shaped slots 87 are formed opposite each other at the same axial position on the tubular body of the inner tube 81, with a length that does not reach half the circumference of the tubular body of the inner tube 81. Therefore, opposite non-slotted portions are formed between the opposing arc-shaped slots 87. Similarly, next to an arc-shaped slot 87, another arc-shaped slot 87 is formed at the same axial position on the tubular body of the inner tube 81, with a length that does not reach half the circumference of the tubular body of the inner tube 81. Similarly, opposite non-slotted portions are formed between the opposing arc-shaped slots 87.

[0081] Furthermore, adjacent arc-shaped slots 87 are offset by approximately 90 degrees with respect to the central axis of the housing. As a result, the non-slit portions between opposing arc-shaped slots 87 and the opposing non-slit portions are not adjacent in the axial direction of the tubular body of the inner tube body 81. The size of the arc of each arc-shaped slot 87 is slightly larger than 1 / 4 of the circumference of the tubular body of the inner tube body 81. The distance between adjacent arc-shaped slots 87 is approximately the same. While it is preferable for the arc-shaped slots 87 to be a combination of opposing slits as described above, they may also consist of a single arc-shaped slot 87 that is slightly larger than 1 / 2 of the circumference.

[0082] Furthermore, the inner tube 3b may be provided with a spiral slot as shown and explained in Figure 11, an annular slot as shown and explained in Figure 12, and a number of ring portions arranged parallel to the axial direction and slightly spaced apart as shown and explained in Figure 14, and connecting portions that connect adjacent ring portions, and the connecting portions adjacent to each other in the axial direction may be continuous in the axial direction.

[0083] As the forming material for the inner tube body 81, metal tubes, rigid synthetic resin tubes, etc., can be used. As metal tubes, stainless steel (SUS304, SUS316, etc.) and superelastic metal tubes are preferred. As rigid synthetic resin tubes, tubes made of rigid resins such as fluororesins like PTFE and ETFE, polyimide, polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefin (e.g., polyethylene, polypropylene), polyamide, polyimide, and polyetheretherketone can be used. The wall thickness of the inner tube body 81 is preferably about 0.05 to 0.2 mm.

[0084] The formation of the aforementioned spiral openings, arc-shaped slots, etc., in metal tubes can be carried out by laser processing (e.g., YAG laser), electrical discharge machining, chemical etching, cutting, etc.

[0085] Furthermore, the inner tube 3b of this embodiment has an arc-shaped slot and is equipped with a covering portion 86 that fluid-tightly covers the outer and / or inner surface of the inner tube 3b in the portion where the arc-shaped slot is provided. The covering portion 86 may also be provided fluid-tightly on the inner surface of the inner tube body 81. Alternatively, the covering portion 86 may be provided fluid-tightly on both the inner and outer surfaces of the inner tube body 81. By providing this covering portion 86, it is possible to prevent the outflow of liquid, gas, or solid matter (cutting material) from the inner tube 3b. For example, when using the inner tube 3b to suck up cutting material with the inner lumen 83, the suction pressure can be maintained from the spiral opening 84 without leaking from slots such as the arc-shaped slot 87.

[0086] The covering portion 86 is preferably formed from a synthetic resin. Examples of synthetic resins used for the covering portion 86 include polyolefins (e.g., polyethylene, polypropylene), polyolefin elastomers (e.g., polyethylene elastomers, polypropylene elastomers, elastomers using ethylene-propylene copolymers, etc.), polyvinyl chloride, ethylene-vinyl acetate copolymers, polyamide elastomers, polyurethane, thermoplastic resins such as fluororesins, and silicone rubber. Polyethylene, polyamide elastomer, or polyurethane are preferred. Furthermore, the covering portion 86 is preferably flexible enough not to hinder the curvature of the inner tube body.

[0087] Next, the outer tube 2c will be described. As shown in Figures 32, 37 to 41, the outer tube 2c comprises a tip opening 23, a lumen 11 communicating with the tip opening 23, a balloon 22 provided on the outer surface of the tip, a balloon lumen 28 communicating with the inside of the balloon 22, a deformable portion 21 located on the tip side of the balloon 22 and capable of changing the orientation of the tip opening 23, and an operating portion 30 for operating the orientation of the tip opening 23 in the deformable portion 21. The balloon 22 is the same as described above. Note that the biological organ stenosis penetration device 1b of this embodiment may not have a balloon 22 and a balloon lumen 28.

[0088] As shown in Figures 32, 37 to 41, the outer tube 2c comprises an outer tube body 20c having an inner layer 41 and an outer layer 42 covering the inner layer 41, and an operating part 30 attached to the rear end of the outer tube body 20c. The outer surface of the inner layer 41 may also be covered with a reinforcing body. The same reinforcing body as the reinforcing body 43 described above can be suitably used.

[0089] Furthermore, as shown in Figures 37 and 41, a balloon lumen 28 is formed inside the wall of the outer tube body 20c. The balloon lumen 28 communicates with the inside of the balloon 22 at one end opening, and communicates with the balloon expansion fluid port 35 at the other end opening. The outer tube 2c is located at the tip and includes a deformable portion 21c that can change the direction of the tip opening 23, an operating portion 30 that operates the direction of the tip opening 23 in the deformable portion 21c, and a first traction wire 24 and a second traction wire 25, one end of which is fixed to the tip of the deformable portion 21c of the outer tube 2c or near the tip opening 23.

[0090] As shown in Figures 32 and 37, the outer tube 2c includes a first traction wire 24, one end of which is fixed to the tip or near the tip opening 23 of the deformable portion 21c of the outer tube 2c, and the other end of which extends outward from the rear end of the outer tube 2c; and a second traction wire 25, one end of which is fixed to the tip or near the tip opening 23 of the deformable portion 21c of the outer tube 2c and opposite to the first traction wire 24, and the other end of which extends outward from the rear end of the outer tube 2c. By selectively tractioning the first traction wire 24 and the second traction wire 25, the orientation of the tip opening 23 in the deformable portion 21c can be changed to different directions.

[0091] In particular, in the biological organ constriction penetration device 1b of this embodiment, when the orientation of the tip opening 23 at the deformable portion 21c of the outer tube 2c is changed by pulling the same predetermined length of the first traction wire 24 and the second traction wire 25, the radius of curvature of the deformable portion 21c (tip of the biological organ constriction penetration device 1b) due to pulling by the first traction wire 24 is different from the radius of curvature of the deformable portion 21c (tip of the biological organ constriction penetration device 1b) due to pulling by the second traction wire 25. In other words, the radius of curvature of the deformable portion 21c when the orientation of the tip opening 23 at the biological organ constriction penetration device 1b is changed by pulling the first traction wire 24 for a predetermined length is different from the radius of curvature of the deformable portion 21c when the orientation of the tip opening 23 at the tip opening 23 is changed by pulling the second traction wire 25 for the same predetermined length as the first traction wire 24.

[0092] The intravascular stenosis penetration device 1b in this embodiment has a deformable portion 21c, in other words, the tip of the intravascular stenosis penetration device 1b, which can be bent at different radii of curvature. Therefore, it can be used not only to accommodate curves in blood vessels with large radii of curvature, but also to curves in blood vessels with small radii of curvature. It can then be advanced through blood vessels having these curves. This makes it easy to insert the stenosis insertion portion of the tip 82 of the inner tube 3b into the intravascular stenosis (intravascular stenosis). Further advancement of the stenosis insertion portion makes it possible to improve the intravascular stenosis (intravascular stenosis). Furthermore, if the stenosis insertion portion provided at the tip 82 of the inner tube 3b has a cutting function, it can cut the embolic material in the intravascular stenosis (intravascular stenosis) and aspirate the cut material using the lumen of the inner tube, thereby achieving good improvement of the intravascular stenosis.

[0093] Furthermore, as shown in Figures 37 to 41, in the biological organ stenosis penetration device 1b of this embodiment, the outer tube 2c includes a first traction wire insertion lumen 46 provided within the wall of the outer tube 2c, a second traction wire insertion lumen 47 provided within the wall of the outer tube 2c, a first traction wire protrusion opening 26 whose one end is located near the tip or tip opening 23 of the deformable portion 21c of the outer tube 2c, extends toward the rear end of the outer tube 2c, and allows the first traction wire 24 to protrude from the side surface of the outer tube 2c when the first traction wire 24 is being pulled, and a second traction wire protrusion opening 27 whose one end is located near the tip or tip opening 23 of the deformable portion 21c of the outer tube 2c, extends toward the rear end of the outer tube 2c, and allows the second traction wire 25 to protrude from the side surface of the outer tube 2c when the second traction wire 25 is being pulled.

[0094] Furthermore, the rear end 27b of the second traction wire protrusion opening 27 is located on the rear end side of the outer tube 2c, compared to the rear end 26b of the first traction wire protrusion opening 26. For this reason, the maximum protrusion length of the second traction wire 25 from the second traction wire protrusion opening 27 is longer than the maximum protrusion length of the first traction wire 24 from the first traction wire protrusion opening 26.

[0095] Furthermore, as shown in Figures 32, 37 to 41, the outer tube 2c allows the first tow wire 24 to pass through the first tow wire insertion lumen 46, and the second tow wire 25 to pass through the second tow wire insertion lumen 47. As shown in Figures 32, 37 to 41, the rear end of the first tow wire 24 extends outward from the first tow wire port 33, and a gripping portion 24a is provided at its rear end. Similarly, the rear end of the second tow wire 25 extends outward from the second tow wire port 34, and a gripping portion 25a is provided at its rear end. As shown in Figures 37 to 41, the first tow wire 24 and the second tow wire 25 are arranged to face each other. Specifically, the first tow wire insertion lumen 46 and the second tow wire insertion lumen 47 are formed to face each other.

[0096] As shown in Figures 37 and 38, the outer tube 2c has a first traction wire protrusion opening 26 that extends towards the rear end of the outer tube 2c, with one end (starting end) 26a located near the tip or tip opening 23 of the deformable portion 21c of the outer tube 2c. This first traction wire protrusion opening 26 communicates with the first traction wire insertion lumen 46. The first traction wire protrusion opening 26 has a width wider than the outer diameter of the first traction wire 24, allowing the first traction wire 24 to protrude from the first traction wire protrusion opening 26 located on the side of the outer tube 2c when the first traction wire 24 is being pulled. The first traction wire protrusion opening 26 has a starting end (one end) 26a located near the tip or tip opening 23 of the deformable portion 21c of the outer tube 2c, and a terminal end (other end) 26b located rearward in a predetermined longitudinal direction.

[0097] As shown in Figure 42, when the first towing wire 24 is towed and the deformable portion 21c is bent, the first towing wire 24 protrudes to the outside between the starting end 26a and the ending end 26b of the first towing wire protrusion opening 26. When the first towing wire 24 is towed, if the first towing wire 24 comes into contact with the ending end 26b of the first towing wire protrusion opening 26, the sliding resistance gradually increases, and once the first towing wire 24 has been towed for a certain length, further towing is restricted. For this reason, the deformation (bending) of the deformable portion 21c due to the towing of the first towing wire 24 is also restricted. In this embodiment, the bending of the deformable portion 21c due to the towing of the first towing wire 24 is restricted to the extent shown in Figure 42. As a variation of the towing restriction, the operating unit 30 may have a mechanism for pre-defining the towing length of the first towing wire 24. An example of such a mechanism is to provide a projection on the outer circumference of the first traction wire 24 inside the first traction wire port 33, and to provide a mechanism in which the projection engages with the opening or lumen of the first traction wire port 33 so that the wire cannot be pulled beyond a predetermined length.

[0098] Furthermore, as shown in Figures 37 to 39, the outer tube 2c has a first end (start end) 27a located near the tip or tip opening 23 of the deformable portion 21c of the outer tube 2c, and is equipped with a second traction wire protrusion opening 27 extending towards the rear end of the outer tube 2c. This first traction wire protrusion opening 27 is in communication with the second traction wire insertion lumen 47. The second traction wire protrusion opening 27 has a width wider than the outer diameter of the second traction wire 25, and allows the second traction wire 25 to protrude from the second traction wire protrusion opening 27 located on the side surface of the outer tube 2c when the second traction wire 25 is being pulled. The second traction wire protrusion opening 27 has a start end (one end) 27a located near the tip or tip opening 23 of the deformable portion 21c of the outer tube 2c, and a terminal end (other end) 27b located rearward in a predetermined longitudinal direction.

[0099] Therefore, as shown in Figures 37 and 39, a portion where the second traction wire protrusion opening 27 exists is formed in a portion where the first traction wire protrusion opening 26 does not exist (the F-F line portion, from the end of the first traction wire protrusion opening 26 towards the base end). Also, as shown in Figure 40, a portion where neither the first traction wire protrusion opening 26 nor the second traction wire protrusion opening 27 exists is formed in a portion where the second traction wire protrusion opening 27 does not exist, from the end of the second traction wire protrusion opening 27 towards the base end.

[0100] Furthermore, as shown in Figure 43, when the second traction wire 25 is pulled and the deformable portion 21c is bent, the second traction wire 25 protrudes to the outside between the starting end 27a and the ending end 27b of the second traction wire protrusion opening 27. When the second traction wire 25 is pulled, if the second traction wire 25 comes into contact with the ending end 27a of the second traction wire protrusion opening 27, the sliding resistance gradually increases, and once the second traction wire 25 has been pulled for a certain length, further pulling is restricted. For this reason, the deformation (bending) of the deformable portion 21c due to the pulling of the second traction wire 25 is also restricted. In this embodiment, the bending of the deformable portion 21c due to the pulling of the second traction wire 25 is restricted to the extent shown in Figure 43. As a variation of the restriction of pulling, the operating unit 30 may have a mechanism to pre-define the pulling length of the second traction wire 25. An example of such a mechanism is to provide a projection on the outer circumference of the second traction wire 25 inside the second traction wire port 34, and to provide a mechanism in which the projection engages with the opening or lumen of the second traction wire port 34 so that the wire cannot be pulled beyond a predetermined length.

[0101] Furthermore, the end (other end) 27b of the second traction wire protrusion opening 27 is located a predetermined length further towards the rear end of the outer tube 2c than the end (other end) 26b of the first traction wire protrusion opening 26. In other words, the length of the second traction wire protrusion opening 27 is longer than the length of the first traction wire protrusion opening 26.

[0102] The distance between the end (other end) 26b of the first traction wire protrusion opening 26 and the end (other end) 27b of the second traction wire protrusion opening 27 is preferably 5 to 30 mm, and particularly preferably 10 to 20 mm. The axial length of the first traction wire protrusion opening 26 is preferably 5 to 20 mm, and particularly preferably 7 to 10 mm. The axial length of the second traction wire protrusion opening 27 is preferably 10 to 40 mm, and particularly preferably 14 to 20 mm. Furthermore, the difference between the axial length of the first traction wire protrusion opening 26 and the axial length of the second traction wire protrusion opening 27 is preferably 3 to 35 mm, and particularly preferably 10 to 15 mm.

[0103] As shown in Figures 42 and 43, the maximum protruding length of the second traction wire 25 from the second traction wire protrusion opening 27 is longer than the maximum protruding length of the first traction wire 24 from the first traction wire protrusion opening 26. As shown in Figures 42 and 43, the degree of deformation (bending) of the deformable portion 21c due to traction of the first traction wire 24 is greater than the degree of deformation (bending) of the deformable portion 21c due to traction of the second traction wire 25. Specifically, the radius of curvature of the deformable portion 21c deformed by traction of the second traction wire 25 is greater than the radius of curvature of the deformable portion 21c deformed by traction of the first traction wire 24. This allows for the selection of the deformation mode by selecting the traction wire when the intravascular stenosis penetration device 1b is advancing through curved sections of blood vessels with a large radius of curvature, and when it is advancing through curved sections of blood vessels with a small radius of curvature. In this embodiment, the tip 26a of the first traction wire protrusion opening 26 and the tip 27a of the second traction wire protrusion opening 27 are located at approximately the same position in the axial direction of the outer tube 2c. However, the embodiment is not limited to this configuration, and the tip 26a of the first traction wire protrusion opening 26 and the tip 27a of the second traction wire protrusion opening 27 may be located at positions offset from the axial direction of the outer tube 2c.

[0104] Furthermore, the starting end (one end) 26a of the first traction wire protruding opening 26 and the starting end (one end) 27a of the second traction wire protruding opening 27 are preferably at the same position as the tip of the deformable portion 21c or near the tip opening 23, but they may be offset.The operating part of the outer tube 2c of the internal organ stenosis penetration device 1b in this embodiment is the same as the operating part 3 described above.The operating part of the outer tube 2c of the internal organ stenosis penetration device 1b in this embodiment may be the same as the operating part 30a described above.The materials described above are preferably used as forming materials for the inner layer 41 and outer layer 42 of the outer tube body 20c.If a reinforcing body is provided covering the outer surface of the inner layer 41, the one described in the reinforcing body 43 described above is preferably used.

[0105] The present invention provides a device for penetrating constricted areas within biological organs, comprising an outer tube having a tip opening, a lumen communicating with the tip opening, a balloon provided on the outer surface of the tip, and a balloon lumen communicating with the inside of the balloon; and an inner tube that can be inserted into the lumen of the outer tube and has a guide wire lumen, wherein the inner tube has a tip portion that can protrude from the tip opening of the outer tube and a constriction insertion portion provided at the tip that can enter a constricted area within a biological organ; the outer tube has a deformable portion located on the tip side of the balloon that can change the direction of the tip opening, and an operating portion for operating the direction of the tip opening in the deformable portion.

[0106] In this intravascular vein stenosis penetration device, even if the vein affected by deep vein thrombosis is curved or tortuous, the outer tube is positioned distal to the balloon and is equipped with a deformable section that allows the direction of the tip opening to be changed, as well as an operating section that controls the direction of the tip opening in the deformable section. Therefore, the tip opening can be changed to the direction in which the device will advance, and the direction of the tip opening can be changed while the balloon is inflated and the device is fixed inside the vein. This allows the device's stenosis improvement site to quickly reach and penetrate the stenotic section of the target vein.

[0107] Embodiments of the present invention for a device that penetrates a constricted area in a biological organ are as follows: (1) A device that penetrates a constricted area in a biological organ, comprising: an outer tube having a tip opening, a lumen communicating with the tip opening, a balloon provided on the outer surface of the tip, and a balloon lumen communicating with the inside of the balloon; and an inner tube that can be inserted into the lumen of the outer tube and has a guide wire lumen, wherein the inner tube has a tip portion that can protrude from the tip opening of the outer tube and a constriction insertion portion provided at the tip that can enter a constricted area in a biological organ, and the outer tube has a deformable portion located on the tip side of the balloon and capable of changing the orientation of the tip opening, and an operating portion for operating the orientation of the tip opening in the deformable portion.

[0108] This device for penetrating constricted areas within biological organs comprises an outer tube having a tip opening, a lumen communicating with the tip opening, a balloon provided on the outer surface of the tip, and a balloon lumen communicating with the inside of the balloon; and an inner tube that can be inserted into the lumen of the outer tube and has a guide wire lumen. The inner tube has a tip that can protrude from the tip opening of the outer tube and a constriction insertion portion provided at the tip that can enter a constricted area within a biological organ. The outer tube has a deformable portion located on the tip side of the balloon that can change the direction of the tip opening, and an operating portion that controls the direction of the tip opening in the deformable portion. In this intravascular vein stenosis penetration device, even if the vein affected by deep vein thrombosis is curved or tortuous, the outer tube is positioned distal to the balloon and is equipped with a deformable section that allows the direction of the tip opening to be changed, as well as an operating section that controls the direction of the tip opening in the deformable section. Therefore, the tip opening can be changed to the direction in which the device will advance, and the direction of the tip opening can be changed while the balloon is inflated and the device is fixed inside the vein. This allows the device's stenosis improvement site to quickly reach and penetrate the stenotic section of the target vein.

[0109] Furthermore, the embodiments of the above-mentioned intraorganic constriction penetration device may also be as follows: (2) The intraorganic constriction penetration device according to (1) above, wherein the outer tube comprises an inner layer, a reinforcing body covering the outer surface of the inner layer, and an outer layer covering the reinforcing body, and the balloon lumen is formed within the wall of the outer tube. (3) The intraorganic constriction penetration device according to (1) or (2) above, wherein the constriction insertion portion is provided with a position-holding outer surface portion that enables the position of the constriction insertion portion to be held by contact with the inside of the intraorganic constriction when it has entered the intraorganic constriction. (4) The intraorganic constriction penetration device according to (3) above, wherein the position-holding outer surface portion is a spiral groove or a plurality of annular grooves provided on the outer surface of the tip of the constriction insertion portion. (5) The internal organ stenosis penetration device according to (3) above, wherein the internal tube comprises an internal tube body having the guide wire lumen and a spiral fin provided on the outer surface of the internal tube body and extending from the tip to the rear end of the internal tube body, the tip of the spiral fin forming the position-holding outer surface, the internal tube is rotatable within the external tube, and the external tube has a port at the rear end of the external tube that communicates with the inside of the external tube. (6) The internal organ stenosis penetration device according to any one of (1) to (5) above, wherein the external tube comprises a first traction wire, one end of which is fixed to the tip of the deformable portion of the external tube or near the tip opening, and the other end of which extends outward from the rear end of the external tube, and the orientation of the tip opening in the deformable portion can be changed by traction operation of the first traction wire. (7) The intraorganic organ stenosis penetration device according to (6) above, wherein the outer tube is provided with a lumen for inserting a first traction wire located within the wall, and the first traction wire is inserted through the lumen for inserting the first traction wire. (8) The intraorganic organ stenosis penetration device according to (6) or (7) above, wherein the outer tube comprises an inner layer, a reinforcing body covering the outer surface of the inner layer, and an outer layer covering the reinforcing body, and the tip of the first traction wire is joined to the tip of the reinforcing body.(9) The intra-organ stenosis penetration device according to any one of (1) to (8) above, wherein the outer tube comprises a first traction wire, one end of which is fixed to the tip of the deformable portion of the outer tube or near the tip opening, and the other end of which extends outward from the rear end of the outer tube, and a second traction wire, one end of which is fixed to the tip of the deformable portion of the outer tube or near the tip opening and opposite to the first traction wire, and the other end of which extends outward from the rear end of the outer tube, and the orientation of the tip opening in the deformable portion can be changed in different directions by selective traction operation of the first traction wire and the second traction wire. (10) The intra-organ stenosis penetration device according to (9) above, wherein the outer tube comprises a first traction wire insertion lumen and a second traction wire insertion lumen provided in the wall, the first traction wire is inserted through the first traction wire insertion lumen, and the second traction wire is inserted through the second traction wire insertion lumen. (11) The intraorganic organ stenosis penetration device according to (9) or (10), wherein the outer tube comprises an inner layer, a reinforcing body covering the outer surface of the inner layer, and an outer layer covering the reinforcing body, and the tips of the first and second traction wires are joined to the tips of the reinforcing body. (12) The intraorganic organ stenosis penetration device according to (2), (8) or (11), wherein the tip of the reinforcing body is a deformable portion. (13) The intraorganic organ stenosis penetration device according to any one of (1) to (12) above, wherein the outer tube comprises an inner layer, a reinforcing body covering the outer surface of the inner layer, an outer layer covering the reinforcing body, and a first traction wire, one end of which is fixed to the tip of the deformable portion of the outer tube or near the tip opening, and the other end of which extends outward from the rear end of the outer tube, and the orientation of the tip opening in the deformable portion can be changed by traction operation of the first traction wire, further comprising the reinforcing body having an easily deformable tip and a ring portion at the tip, and the tip of the first traction wire being joined to the ring portion of the reinforcing body. (14) The intraorganic organ stenosis penetration device according to any one of (1) to (13) above, wherein the outer tube comprises an easily deformable portion formed by a plurality of annular recesses or spiral recesses provided on the outer or inner surface near the balloon and on the tip side.

[0110] Furthermore, embodiments of the present invention's device for penetrating constricted areas within biological organs are as follows. (15) A device for penetrating a constricted area in a biological organ, comprising an outer tube having a tip opening and a lumen communicating with the tip opening, and an inner tube that can be inserted into the lumen of the outer tube, wherein the inner tube has a tip portion that can protrude from the tip opening of the outer tube and a constriction insertion portion provided at the tip portion that can enter a constricted area in a biological organ, the outer tube comprises a deformable portion located at the tip portion that can change the direction of the tip opening, an operating portion for operating the direction of the tip opening in the deformable portion, and a first traction wire and a second traction wire, one end of which is fixed to the tip portion of the deformable portion of the outer tube or near the tip opening, the radius of curvature of the deformable portion when the direction of the tip opening is changed by a traction operation of the first traction wire for a predetermined length in the device for penetrating a constricted area in a biological organ, wherein the radius of curvature of the deformable portion when the direction of the tip opening is changed by a traction operation of the second traction wire for the same predetermined length as the first traction wire.

[0111] Furthermore, the following may be an embodiment of the above-mentioned intra-organ stenosis penetration device: (16) The intra-organ stenosis penetration device according to (15) above, wherein the outer tube comprises a first traction wire insertion lumen provided in the wall of the outer tube, a second traction wire insertion lumen provided in the wall of the outer tube, a first traction wire protrusion opening with one end located at the tip of the deformable portion of the outer tube or near the tip opening, extending toward the rear end of the outer tube and allowing the first traction wire to protrude from the side surface of the outer tube when the first traction wire is pulled, and a second traction wire protrusion opening with one end located at the tip of the deformable portion of the outer tube or near the tip opening, extending toward the rear end of the outer tube and allowing the second traction wire to protrude from the side surface of the outer tube when the second traction wire is pulled, and further, the rear end of the second traction wire protrusion opening is located toward the rear end of the outer tube than the rear end of the first traction wire protrusion opening. (17) The device for penetrating a constricted area in a biological organ according to (16), wherein the rear end of the second traction wire protrusion opening is located on the rear end side of the outer tube than the rear end of the first traction wire protrusion opening, and the maximum length of the second traction wire that can protrude from the second traction wire protrusion opening is longer than the maximum length of the first traction wire that can protrude from the first traction wire protrusion opening. (18) The device for penetrating a constricted area in a biological organ according to any one of (15) to (17), wherein the inner tube is provided with a hemispherical tip, and the hemispherical tip is further provided with a spiral opening having a start end and a end. (19) The device for penetrating a constricted area in a biological organ according to any one of (15) to (18), wherein the inner tube is provided with a plurality of arc-shaped slots having a start end and an end, and a covering portion is provided which is fluid-tightly covering the outer surface and / or inner surface of the inner tube in at least the portion where the arc-shaped slots are provided.

Claims

1. A device for penetrating a constricted area in a biological organ, comprising: an outer tube having a tip opening, a lumen communicating with the tip opening, a balloon provided on the outer surface of the tip portion, and a balloon lumen communicating with the inside of the balloon; and an inner tube that can be inserted into the lumen of the outer tube and has a guide wire lumen, wherein the inner tube has a tip portion that can protrude from the tip opening of the outer tube and a constriction insertion portion provided at the tip portion that can enter a constricted area in a biological organ; and the outer tube has a deformable portion located on the tip side of the balloon and capable of changing the orientation of the tip opening, and an operating portion for operating the orientation of the tip opening in the deformable portion.

2. The device for penetrating a constricted portion of a biological organ according to claim 1, wherein the outer tube comprises an inner layer, a reinforcing body covering the outer surface of the inner layer, and an outer layer covering the reinforcing body, and the balloon lumen is formed within the wall of the outer tube.

3. The device for penetrating a constricted area within a biological organ according to claim 1 or 2, wherein the constricted insertion portion is provided with a position-holding outer surface portion that enables the position of the constricted insertion portion to be maintained by contact with the inside of the constricted area within the biological organ when it has entered the constricted area within the biological organ.

4. The device for penetrating a constricted portion inside a biological organ according to claim 3, wherein the position-holding outer surface portion is a spiral groove or a plurality of annular grooves provided on the outer surface of the tip of the constricted insertion portion.

5. The device for penetrating a constricted portion of a biological organ according to claim 3, wherein the inner tube comprises an inner tube body having the guide wire lumen, and a spiral fin provided on the outer surface of the inner tube body and extending from the tip to the rear end of the inner tube body, the tip of the spiral fin forming the position-holding outer surface, the inner tube being rotatable within the outer tube, and the outer tube having a port at its rear end that communicates with the inside of the outer tube.

6. The device for penetrating a constricted portion of a biological organ according to claim 1 or 2, wherein the outer tube is provided with a first traction wire, one end of which is fixed to the tip of the deformable portion of the outer tube or near the tip opening, and the other end of which extends outward from the rear end of the outer tube, and the orientation of the tip opening in the deformable portion can be changed by traction operation of the first traction wire.

7. The device for penetrating a constricted portion of a biological organ according to claim 6, wherein the outer tube is provided with a lumen for inserting a first traction wire located within its wall, and the first traction wire is inserted through the lumen for inserting the first traction wire.

8. The device for penetrating a constricted portion of a biological organ according to claim 6, wherein the outer tube comprises an inner layer, a reinforcing body covering the outer surface of the inner layer, and an outer layer covering the reinforcing body, and the tip of the first traction wire is joined to the tip of the reinforcing body.

9. The device for penetrating a constricted portion of a biological organ according to claim 1 or 2, wherein the outer tube comprises a first traction wire, one end of which is fixed to the tip of the deformable portion of the outer tube or near the tip opening, and the other end of which extends outward from the rear end of the outer tube, and a second traction wire, one end of which is fixed to the tip of the deformable portion of the outer tube or near the tip opening and opposite to the first traction wire, and the other end of which extends outward from the rear end of the outer tube, and the orientation of the tip opening in the deformable portion can be changed in different directions by selective traction operation of the first traction wire and the second traction wire.

10. The device for penetrating a constricted portion of a biological organ according to claim 9, wherein the outer tube comprises a first traction wire insertion lumen and a second traction wire insertion lumen provided within the wall, the first traction wire being inserted through the first traction wire insertion lumen and the second traction wire being inserted through the second traction wire insertion lumen.

11. The device for penetrating a constricted portion of a biological organ according to claim 9, wherein the outer tube comprises an inner layer, a reinforcing body covering the outer surface of the inner layer, and an outer layer covering the reinforcing body, and the tips of the first traction wire and the second traction wire are joined to the tips of the reinforcing body.

12. The device for penetrating a constricted portion within a biological organ according to claim 2, 8, or 11, wherein the reinforcing member has a tip portion that is easily deformable.

13. The device for penetrating a constricted portion of a biological organ according to claim 1 or 2, wherein the outer tube comprises an inner layer, a reinforcing body covering the outer surface of the inner layer, an outer layer covering the reinforcing body, and a first traction wire, one end of which is fixed to the tip of the deformable portion of the outer tube or near the tip opening, and the other end of which extends outward from the rear end of the outer tube, and the orientation of the tip opening in the deformable portion can be changed by traction of the first traction wire, and furthermore, the reinforcing body has a tip that is easily deformable and has a ring portion at its tip, and the tip of the first traction wire is joined to the ring portion of the reinforcing body.

14. The device for penetrating a constricted portion within a biological organ according to claim 1 or 2, wherein the outer tube comprises a plurality of easily deformable portions formed by a plurality of annular recesses or spiral recesses provided on the outer or inner surface near the balloon and on the tip side.

15. A device for penetrating a constricted area in a biological organ, comprising an outer tube having a tip opening and a lumen communicating with the tip opening, and an inner tube that can be inserted into the lumen of the outer tube, wherein the inner tube comprises a tip portion that can protrude from the tip opening of the outer tube and a constriction insertion portion provided at the tip portion that can enter a constricted area in a biological organ, the outer tube comprises a deformable portion located at the tip portion that can change the direction of the tip opening, an operating portion for operating the direction of the tip opening in the deformable portion, and a first traction wire and a second traction wire, one end of which is fixed to the tip portion of the deformable portion of the outer tube or near the tip opening, wherein the radius of curvature of the deformable portion when the direction of the tip opening is changed by a traction operation of the first traction wire for a predetermined length is different from the radius of curvature of the deformable portion when the direction of the tip opening is changed by a traction operation of the second traction wire for the same predetermined length as the first traction wire.

16. The device for penetrating a constricted portion of a biological organ according to claim 15, wherein the outer tube comprises a first traction wire insertion lumen provided within the wall of the outer tube, a second traction wire insertion lumen provided within the wall of the outer tube, a first traction wire protrusion opening with one end located at the tip of the deformable portion of the outer tube or near the tip opening, extending toward the rear end of the outer tube, and allowing the first traction wire to protrude from the side surface of the outer tube when the first traction wire is pulled, and a second traction wire protrusion opening with one end located at the tip of the deformable portion of the outer tube or near the tip opening, extending toward the rear end of the outer tube, and allowing the second traction wire to protrude from the side surface of the outer tube when the second traction wire is pulled, and further, the rear end of the second traction wire protrusion opening is located toward the rear end of the outer tube than the rear end of the first traction wire protrusion opening.

17. The device for penetrating a constricted portion of a biological organ according to claim 16, wherein the rear end of the second traction wire protrusion opening is located on the rear end side of the outer tube than the rear end of the first traction wire protrusion opening, and the length of the second traction wire that can protrude from the second traction wire protrusion opening is longer than the length of the first traction wire that can protrude from the first traction wire protrusion opening.

18. The internal tube comprises a hemispherical tip, and the hemispherical tip further comprises a spiral opening having a starting end and a terminating end, as described in claim 15 or 16.

19. The internal tube has a plurality of arc-shaped slots having a starting end and an ending end, and comprises a covering portion that is fluid-tightly covering the outer surface and / or inner surface of the internal tube at least in the portion where the arc-shaped slots are provided, as described in claim 15 or 16.

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