JP2018130232A - Medical long body - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical long body capable of adding a scoring function to a balloon in executing a treatment for a narrow section or the like without deteriorating the flexibility of the balloon.SOLUTION: A balloon catheter 10 includes a shaft 100 having a lumen 105 into which liquid can be injected, a tip member 200 disposed at a tip 101 of the shaft, and a balloon 300 fixed to the shaft and communicated with the lumen of the shaft. The tip member includes a lumen 205a that forms a guide wire lumen 205, and a guide wire port 204a communicated with the lumen of the tip member. The shaft includes a tip opening 101a that is open toward the lumen of the tip member and an auxiliary expansion part 110 for covering the tip opening. A constituent material of the auxiliary expansion part is more flexible than a constituent material of the balloon, and the auxiliary expansion part can be expanded in the lumen of the tip member so as to narrow the guide wire lumen.SELECTED DRAWING: Figure 4

Description

  The present invention relates to a medical long body used for expansion of a stenosis part, an obstruction part, etc. formed in a living body lumen.

  A balloon catheter is widely known as a medical instrument that expands a stenosis part or a blockage part formed in a living body lumen such as a blood vessel. As one of balloon catheters, a scoring balloon catheter (cutting balloon catheter) to which a scoring function is added is known. The scoring balloon catheter has a blade attached to the outer surface of the balloon. In general, the blade is made of resin, metal, or the like having higher rigidity than the balloon (see, for example, Patent Document 1).

  The scoring balloon catheter can push and widen the stenosis part while making a cut in the stenosis part by causing the blade attached to the balloon to bite into the stenosis part in the treatment of expanding the stenosis part. For this reason, a scoring balloon catheter can exhibit a high therapeutic effect also in the treatment of a lesioned part (arteriosclerosis part etc.) where calcification has progressed.

Special table 2008-504059

  However, in a balloon catheter, when a relatively rigid blade made of a member different from the balloon is attached to the balloon, the flexibility of the balloon is reduced. Property) is impaired.

  The present invention has been made in view of the above problems, and is a medical long length capable of adding a scoring function to a balloon when performing treatment for a stenosis or the like without reducing the flexibility of the balloon. The purpose is to provide a body.

  A medical elongated body according to the present invention includes a shaft having a lumen into which a fluid can be injected, a tip member disposed at a tip portion of the shaft, a lumen fixed to the shaft, and a lumen of the shaft. A balloon that communicates, and the tip member includes a lumen that forms a guide wire lumen, and a guide wire port that communicates with the lumen of the tip member. A distal opening that opens toward the cavity, and an auxiliary extension that covers the distal opening, and the material of the auxiliary extension is more flexible than the material of the balloon, and the auxiliary extension Is expandable in the lumen of the tip member so as to narrow the guidewire lumen.

  In the medical elongated body according to the present invention, when a fluid is supplied to the lumen of the shaft, the auxiliary extension portion arranged to cover the tip opening of the shaft expands. Since the constituent material of the auxiliary expanding portion is softer than the constituent material of the balloon, the auxiliary expanding portion expands to narrow the guide wire lumen of the tip member before the balloon expands to push and widen the narrowed portion. Therefore, the auxiliary extension portion fixes the guide wire inserted through the guide wire lumen when expanded. Further, when the balloon is expanded in a state where the guide wire is fixed by the auxiliary expansion portion, the balloon is pressed against the narrowed portion together with the outer surface of the balloon. For this reason, the medical elongated body can expand the stenosis in a state where the scoring function is added to the balloon, instead of the guide wire as a blade. Thus, since the blade for adding a scoring function is not directly fixed to the balloon, the flexibility of the balloon is not lowered while the balloon is moving in the living body lumen. . For this reason, the operator or the like can smoothly move the balloon catheter within the living body lumen.

BRIEF DESCRIPTION OF THE DRAWINGS It is a figure which shows the medical elongate body which concerns on 1st Embodiment of this invention, FIG. 1 (A) is a figure which shows the whole structure of a medical elongate body, FIG.1 (B) is a medical elongate. It is a perspective view which shows the front-end | tip part side of a body. It is an expanded sectional view of the part shown with broken-line part 2A in FIG. 1 (A). It is an expanded sectional view showing a situation at the time of an auxiliary extension part expanding. It is an expanded sectional view which shows a mode when a balloon is expanded. 5A is a front view of the medical elongated body viewed from the direction of the arrow 5A shown in FIG. 2, and FIG. 5B is a cross-sectional view taken along the arrow 5B-5B ′ shown in FIG. FIG. 6A to FIG. 6C are cross-sectional views schematically showing procedures of a procedure using the medical long body according to the first embodiment. FIG. 7 (A) to FIG. 7 (C) are cross-sectional views schematically showing the procedure of the procedure using the medical elongated body according to the first embodiment. It is a figure which shows the medical elongate body which concerns on 2nd Embodiment of this invention, FIG. 8 (A) is a figure which shows the whole structure of a medical elongate body, FIG.8 (B) is a medical elongate. It is a perspective view which shows the front-end | tip part side of a body. It is a figure which shows the mode at the time of winding a guide wire around a balloon. FIG. 9 is an enlarged cross-sectional view of a portion indicated by a broken line portion 10A in FIG. 8A, and is an enlarged cross-sectional view showing a state where a guide wire is wound around a balloon and a spiral portion is formed on the guide wire. It is an expanded sectional view which shows a mode when a balloon is expanded. 12A is a front view of the medical elongated body viewed from the direction of the arrow 12A shown in FIG. 9, and FIG. 12B is a cross-sectional view taken along the arrow 12B-12B ′ shown in FIG. FIG. 13 (A) to FIG. 13 (C) are cross-sectional views schematically showing a procedure of a procedure using the medical elongated body according to the second embodiment. FIG. 14A to FIG. 14C are cross-sectional views schematically showing the procedure of the procedure using the medical elongated body according to the second embodiment.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

<First Embodiment>
FIG. 1 to FIG. 5 are diagrams showing the configuration of each part of a balloon catheter (corresponding to a “medical long body”) 10 according to the first embodiment. 6 and 7 are cross-sectional views schematically showing the procedure of the procedure using the balloon catheter 10. FIG.

  Specifically, FIG. 1A is a view showing the overall configuration of the balloon catheter 10 (overall view in the state shown in FIG. 2), and FIG. 1B is an enlarged view of the configuration on the distal end side of the balloon catheter 10. 2 (a perspective view of the state shown in FIG. 2), FIG. 2 to FIG. 4 are enlarged sectional views showing a state where the auxiliary expansion part 110 and the balloon 300 of the balloon catheter 10 are expanded, and FIG. 2 is a front view of the balloon catheter 10 viewed from the direction of the arrow 5A shown in FIG. 2, and FIG. 5B is a cross-sectional view (axial orthogonal cross-sectional view) along the arrow 5B-5B ′ line shown in FIG.

  In FIG. 1, the size of each part of the balloon catheter 10 is exaggerated with respect to the size (outer diameter) of the guide wire W in order to clearly represent the structure of each part of the balloon catheter 10. .

  As shown in FIG. 1 (A), the balloon catheter 10 according to the present embodiment allows a living body to be expanded by inserting a shaft 100 into a living organ and expanding a balloon 300 disposed on the distal end side of the shaft 100 at a stenosis. It is a medical long body that spreads and treats a narrowed part of an organ. Further, as will be described later, the balloon catheter 10 adds a scoring function to the balloon 300 by using the guide wire W when the balloon 300 pushes and widens the narrowed portion of the living organ (see FIGS. 4 and 7). See A)).

  The balloon catheter 10 can be configured as, for example, a PTCA dilatation balloon catheter used to expand a stenosis of a coronary artery. However, the balloon catheter 10 is used for the purpose of treating and improving a stenosis portion formed in a living organ such as another blood vessel, bile duct, trachea, esophagus, other digestive tract, urethra, ear nasal lumen, and other organs. It can also be configured as used.

  The configuration of the balloon catheter 10 will be described.

  As shown in FIG. 2, in general, the balloon catheter 10 includes a shaft 100 having a lumen (expansion lumen) 105 through which fluid can be injected, a distal end member 200 disposed at the distal end portion 101 of the shaft 100, and the shaft 100. And a balloon 300 that communicates with the lumen 105 of the shaft 100, and a hub 400 disposed at the proximal end of the shaft 100.

  In the description of the embodiment, the side on which the distal end member 200 is disposed is referred to as the distal end side of the balloon catheter 10, the side on which the hub 400 is disposed is referred to as the proximal end side of the balloon catheter 10, and the direction in which the shaft 100 extends is referred to. This is referred to as the axial direction of the balloon catheter 10.

  The shaft 100 is composed of a long member having flexibility. The lumen 105 of the shaft 100 extends along the axial direction inside the shaft 100.

  As shown in FIGS. 2 and 3, the shaft 100 includes a distal end opening 101 a that opens toward the inner cavity 205 a of the distal end member 200, and an auxiliary extension portion 110 that covers the distal end opening 101 a. As will be described later, a part of the lumen 205a of the tip member 200 forms a guide wire lumen 205 through which the guide wire W can be inserted.

  The distal end portion 101 of the shaft 100 in which the distal end opening portion 101 a is formed is inclined from the proximal end side to the distal end side in the lumen 205 a of the distal end member 200. In other words, the distal end portion 101 of the shaft 100 is disposed in the inner cavity 205a of the distal end member 200, and has an outer diameter from the proximal end side toward the distal end side in the cross section along the axial direction shown in FIG. It has a tapered shape that gradually decreases.

  As shown in FIG. 3, the tip opening portion 101 a of the shaft 100 opens toward the guide wire port 204 a side of the tip member 200. Therefore, at least a part of the tip opening 101a of the shaft 100 exists on the same plane as the guide wire port 204a in a cross section perpendicular to the axial direction of the shaft 100.

  The tip opening 101a of the shaft 100 may be opened in a non-parallel positional relationship with respect to the guide wire port 204a of the tip member 200 as shown in FIG. You may open in the positional relationship parallel to the wire port 204a.

  The shaft 100 has a hole 108 that communicates the lumen 105 of the shaft 100 and the expansion space 305 (see FIG. 4) of the balloon 300. When a fluid (for example, a contrast medium or physiological saline) is injected into the lumen 105 of the shaft 100, a part of the fluid flows into the auxiliary expansion unit 110 via the tip opening 101a, thereby expanding the auxiliary expansion unit 110. (See FIG. 3). Further, a part of the fluid injected into the lumen 105 of the shaft 100 flows into the expansion space 305 of the balloon 300 through the hole portion 108 and expands the balloon 300 (see FIG. 4).

  As shown in FIG. 2, the shaft 100 includes a guide wire guiding portion 120 that is disposed on the proximal end side with respect to the balloon 300 (the proximal end side in the axial direction with respect to the proximal end portion 303 of the balloon 300).

  The guide wire guiding portion 120 is formed with an insertion portion (insertion hole) 121 through which the guide wire W can be inserted.

  As shown in FIG. 5B, the guide wire guiding portion 120 is fused and integrated with the shaft 100. Fusion of the guide wire guiding portion 120 to the shaft 100 can be performed using a heat shrinkable tube, for example. Fusion can be performed, for example, by the following procedure. An operator arrange | positions the cylindrical member formed with the resin material on the outer surface of the shaft 100, and covers a cylindrical member and the shaft 100 with a predetermined | prescribed heat contraction tube. The worker applies heat to the heat shrinkable tube to shrink the heat shrinkable tube. The cylindrical member melts as the heat-shrinkable tube contracts, and is fused to the outer surface of the shaft 100. A cylindrical member fused to the outer surface of the shaft 100 forms a guide wire guiding portion 120.

  When performing treatment using the balloon catheter 10, an operator or the like inserts the guide wire W into the guide wire lumen 205 formed by the lumen 205 a of the distal end member 200, and further inserts the guide wire W into the guide wire guiding portion 120. By inserting, the guide wire W can be easily guided to the proximal end side of the balloon 300.

  As shown in FIG. 5A, the guide wire guiding portion 120 is located at the same position as the guide wire port 204a with respect to the axis c1 of the shaft 100 (the guide wire guiding portion 120 and the guide wire port 204a are in the circumferential direction). (Overlapping position). The above "same position" refers to the center position of the guide wire guiding portion 120 and the center position of the guide wire port 204a on the axial orthogonal sectional view in the circumferential direction of the shaft 100 indicated by the arrow r shown in FIG. This means that there is no phase difference (angle difference) between them, or that there is a slight phase difference (a phase difference of about several degrees).

  As shown in FIG. 5B, the guide wire guiding portion 120 has a shape protruding from the shaft 100 in a direction orthogonal to the axial direction. The guide wire guiding portion 120 has a rounded end on the protruding side. The shape and structure of the guide wire guiding portion 120 are not particularly limited. For example, the guide wire guiding portion 120 has a cylindrical member having a non-circular cross section, a hook structure that can hold and hold the guide wire W, and the outer surface of the shaft 100. It is also possible to use a plate-like or sheet-like member that forms a space through which the guide wire W can be inserted.

  As shown in FIG. 5B, the inner diameter t1 of the insertion part 121 of the guide wire guiding part 120 is preferably smaller than the inner diameter (diameter of the lumen 105) d1 of the shaft 100. In the balloon catheter 10, the outer diameter of the shaft 100 partially increases as the height of the guide wire guiding portion 120 increases. Therefore, in order to reduce the outer diameter of the shaft 100 to some extent, for example, it is preferable to set the relationship between the inner diameter t1 of the insertion portion 121 of the guide wire guiding portion 120 and the inner diameter d1 of the shaft 100 as described above. However, if the inner diameter t1 of the guide wire guiding portion 120 is extremely reduced, the insertion portion 121 of the guide wire guiding portion 120 becomes excessively small, so that the guide wire W is smoothly inserted into the insertion portion 121. Can be difficult. For this reason, it is preferable to set the inner diameter t1 of the guide wire guiding portion 120 to an appropriate size according to the product specifications or the like, for example, within a range not exceeding the inner diameter d1 of the shaft 100.

  As shown in FIG. 2, the auxiliary extension portion 110 of the shaft 100 is fixed to the distal end portion 101 of the shaft 100 and the proximal end portion 203 of the distal end member 200. Specifically, in the auxiliary extension portion 110, the base end portion 113 of the auxiliary extension portion 110 is sandwiched between the outer surface of the tip end portion 101 of the shaft 100 and the inner surface of the base end portion 203 of the tip member 200. In the state, it is fixed to the shaft 100 and the tip member 200. As a method for fixing the auxiliary extension portion 110, for example, a known method such as fusion or adhesion can be employed.

  The distal end portion 101 in which the distal end opening portion 101 a is formed in the shaft 100 is disposed in the lumen 205 a of the distal end member 200. The auxiliary extension portion 110 disposed so as to cover the distal end opening portion 101 a of the shaft 100 is disposed in the lumen 205 a of the distal end member 200 in the same manner as the distal end portion 101 of the shaft 100.

  The constituent material of the auxiliary expansion part 110 is more flexible than the constituent material of the balloon 300.

  The above-mentioned “the constituent material of the auxiliary expansion portion is more flexible than the constituent material of the balloon” means that the Shore hardness D (conforming to JIS 6253) of the constituent material of the auxiliary expansion portion 110 is the Shore hardness D of the constituent material of the balloon. Means less than. In addition, the relationship between the flexibility of the constituent materials described above is that, in other words, the constituent material of the auxiliary expansion portion 110 and the constituent material of the balloon 300 form the same balloon (the same shape and volume), and the same pressure is applied to each balloon. This means that the auxiliary expansion part 110 is made of a material whose expansion amount is larger than that of the balloon 300 when (for example, recommended expansion pressure) is applied.

  As described above, the constituent material of the auxiliary expansion part 110 is more flexible than the constituent material of the balloon 300. For this reason, when fluid is injected into the lumen 105 of the shaft 100, the auxiliary expansion unit 110 starts expansion before the balloon 300. The auxiliary expansion part 110 narrows the lumen 205 a of the tip member 200 by expanding in the lumen 205 a of the tip member 200 located on the tip side of the shaft 100. The auxiliary extension portion 110 narrows the lumen 205a of the distal end member 200, thereby passing the guide wire W inserted through the guide wire lumen 205 formed by the lumen 205a of the distal end member 200 as will be described later to the inner wall ( Press against and hold (fix) the inner surface) (see FIG. 3).

  In this embodiment, when the balloon 300 is expanded with the guide wire W inserted through the guide wire lumen 205 of the tip member 200, the auxiliary expansion unit 110 expands faster than the balloon 300 (the balloon 300 is recommended). The guide wire W is configured to be fixed at the guide wire lumen 205 of the tip member 200.

  The auxiliary extension part 110 can be comprised with the sheet-like member formed in the magnitude | size which covers the front-end | tip opening part 101a of the shaft 100, for example. The shape and size of the auxiliary extension 110 are not particularly limited as long as they can cover the tip opening 101a of the shaft 100. In addition, the thickness of the auxiliary expansion portion 110 is not particularly limited as long as the auxiliary expansion portion 110 can expand before the balloon 300 under the same pressure condition.

In the present embodiment, the auxiliary extension part 110 is configured to cover the guide wire port 204a when the auxiliary extension part 110 is extended. The above "covering the guide wire port"
When the auxiliary extension portion 110 is expanded with the guide wire W inserted into the guide wire lumen 205 of the tip member 200, the entire opening forming the guide wire port 204a is sealed by the auxiliary extension portion 110 and the guide wire W. (Covered without gaps). By configuring the auxiliary extension portion 110 in this way, it is possible to improve the fixing force for fixing the guide wire W to the tip member 200 when the auxiliary extension portion 110 is expanded.

  As shown in FIGS. 1B and 2, the distal end member 200 includes a distal end portion 201 in which a distal end opening 201 a is formed, a proximal end portion 203 fixed to the shaft 100 and the auxiliary extension portion 110, and a proximal end. The tapered portion 204 is inclined from the side toward the distal end side, and the guide wire port 204a is formed in the tapered portion 204.

  As shown in FIG. 2, the proximal end portion 203 of the distal end member 200 is fixed to the members 100 and 110 while covering both the outer surface of the auxiliary extension portion 110 and the outer surface of the shaft 100. Therefore, since the tip member 200 is fixed while being in contact with both the outer surface of the auxiliary extension portion 110 and the outer surface of the shaft 100, the balloon catheter 10 firmly fixes the shaft 100, the auxiliary extension portion 110, and the tip member 200. Can be fixed to.

  As shown in FIG. 2, the distal end portion of the shaft 100 and the auxiliary extension portion 110 are disposed in the inner cavity 205 a of the distal end member 200. In the lumen 205a of the distal end member 200, a portion (space) on the distal end side relative to the position where the auxiliary expansion portion 110 in a state before expansion deformation is disposed forms a guide wire lumen 205 into which the guide wire W can be inserted. . That is, the guide wire lumen 205 is formed by a part of the lumen 205 a of the tip member 200.

  As shown in FIG. 2, the cross-sectional shape of the guide wire lumen 205 along the axial direction of the distal end member 200 exhibits a shape that gradually widens from the proximal end side toward the distal end side. The cross-sectional shape is formed by the shape of the lumen 205a originally provided in the tip member 200, the shape of the tip portion 101 of the shaft 100 inserted into the lumen 205a, and the shape of the auxiliary extension portion 110. Therefore, for example, by appropriately changing the cross-sectional shape of the lumen 205a of the tip member 200, the cross-sectional shape of the tip portion of the shaft 100, the cross-sectional shape of the auxiliary extension portion 110, and the like, the guide wire lumen 205 of the tip member 200 The cross-sectional shape (the cross-sectional shape before expanding the auxiliary extension portion 110) can be formed into an arbitrary shape.

  As shown in FIG. 5A, the distal end opening 201a of the distal end member 200 is disposed on the distal end side with respect to the guide wire port 204a. The opening diameter of the distal end opening 201a of the distal end member 200 can be formed, for example, substantially the same as the guide wire port 204a.

  Further, in the present embodiment, the tip portion 101 of the shaft 100 is formed in a tapered shape, and the auxiliary extension portion 110 arranged at the tip portion 101 of the shaft 100 is also arranged in an inclined state along the tip portion 101. ing. For this reason, the surgeon or the like inserts the guide wire W into the guide wire lumen 205 through the distal end opening 201a of the distal end member 200, and then guides the guide wire W along the auxiliary extension portion 110 to thereby guide the guide wire W. Can be easily guided toward the guide wire port 204a.

  The constituent material of the tip member 200 is harder than the constituent material of the auxiliary extension portion 110. The magnitude relationship of the hardness mentioned here can be defined based on the Shore hardness D (conforming to JIS 6253).

  As shown in FIG. 4, the balloon 300 includes a distal end portion 301 fixed to the distal end portion 101 of the shaft 100, a proximal end portion 303 fixed to the shaft 100 on the proximal end side with respect to the distal end portion 301, and a distal end portion 301. And a substantially cylindrical extended portion 304 formed between the base end portion 303 and the base end portion 303. Note that a distal end side tapered portion 306 in which the outer diameter of the balloon 300 decreases toward the distal end side is formed on the distal end side of the expanded portion 304 of the balloon 300, and the proximal end side of the expanded portion 304 of the balloon 300 is formed on the proximal end side. A base end side taper 307 portion in which the outer diameter of the balloon 300 decreases toward the base end side is formed.

  As shown in FIG. 4, the balloon 300 forms an expansion space 305 with the outer peripheral surface of the shaft 100. When the fluid flows into the expansion space 305, the balloon 300 expands in a direction (radially outward) orthogonal to the axial direction as shown in FIG. The expansion portion 304 of the balloon 300 applies an expansion force to the stenosis portion S as the balloon 300 is expanded (see FIG. 7A).

  As a method for fixing the balloon 300 to the shaft 100, for example, a known method such as fusion or adhesion can be employed.

  As shown in FIG. 1, the hub 400 has a port 410 that can be connected in a liquid-tight and air-tight manner to a supply device (not shown) such as an indeflator for supplying a fluid (pressurized medium). The port 410 of the hub 400 can be configured by, for example, a known luer taper configured such that a fluid tube or the like can be connected / separated.

  The shaft 100 is connected to the hub 400 in a state where the lumen 105 of the shaft 100 communicates with the flow path in the hub 400. The fluid used to expand the balloon 300 is supplied to the lumen 105 of the shaft 100 via the port 410 of the hub 400.

  Next, constituent materials of each member will be described.

  Examples of the constituent material of the shaft 100 include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer, thermoplastic resins such as soft polyvinyl chloride, polyurethane elastomer, polyamide elastomer, and polyester elastomer. Various elastomers such as polyamide, crystalline plastics such as polyamide, crystalline polyethylene, and crystalline polypropylene can be used.

  Examples of the constituent material of the auxiliary extension 110 include polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, and cross-linked ethylene-vinyl acetate copolymer. Polymers, thermoplastic resins such as polyurethane, polyamide, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber and the like can be used. The auxiliary expansion portion 110 is formed of a constituent material having a Shore hardness D (conforming to JIS 6253) lower than that of the constituent material of the balloon 300 described later.

  Examples of the constituent material of the tip member 200 include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polychlorinated salt, and the like. Polymer materials such as vinyl, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube of the above two or more polymer materials can be used.

  The constituent materials of the balloon 300 include, for example, polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, and cross-linked ethylene-vinyl acetate copolymer. Further, thermoplastic resins such as polyurethane, polyamide, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber and the like can be used.

  As the constituent material of the guide wire guiding portion 120, for example, the same materials as those exemplified as the constituent material of the shaft 100 can be used.

  As shown in FIG. 2, the shaft 100 is provided with contrast markers 103a and 103b. The contrast marker 103a is arranged on the shaft 100 at a position overlapping with a boundary portion between the expansion portion 304 of the balloon 300 and the tip side tapered portion 306 of the balloon 300 in the circumferential direction. Further, the contrast marker 103b is arranged on the shaft 100 at a position overlapping with a boundary portion between the expansion portion 304 of the balloon 300 and the proximal end side tapered portion 307 of the balloon 300 in the circumferential direction. Each of the contrast markers 103a and 103b can be composed of, for example, a ring-shaped member made of a known metal material having contrast properties.

  Next, an operation procedure of the balloon catheter 10 will be described with reference to FIGS.

  As shown in FIGS. 1B and 2, the surgeon or the like causes the guide wire W to be inserted through the guide wire lumen 205 of the distal end member 200 when the balloon catheter 10 is delivered to the stenosis in the blood vessel.

  The guide wire W is inserted into the guide wire lumen 205 from the distal end opening 201a of the distal end member 200, and is led out of the guide wire lumen 205 from the guide wire port 204a.

  An operator or the like guides the guide wire W to the proximal end side of the balloon 300 through the outer surface side of the balloon 300 (for example, the outer surface side above the balloon 300 on the axial orthogonal cross section shown in FIG. 5A). . Further, the surgeon or the like causes the guide wire W to be inserted through the guide wire guiding portion 120 located on the upper side in the circumferential direction on the axial orthogonal cross section on the proximal end side with respect to the balloon 300.

  The surgeon moves the balloon catheter 10 in the blood vessel B along the guide wire W. At that time, the balloon catheter 10 does not have a member for adding a scoring function to the surface of the balloon 300. For this reason, the balloon 300 of the balloon catheter 10 can maintain flexibility. Thereby, the surgeon or the like can smoothly move the balloon catheter 10 in the blood vessel B.

  In addition, since the balloon catheter 10 is configured so that the guide wire W is inserted through the guide wire port 204a of the distal end member 200 disposed on the distal end side of the shaft 100, the balloon catheter 10 is guided over the entire axial length of the shaft 100. There is no need to insert the wire W. For this reason, the surgeon or the like can easily and smoothly insert the guide wire W into the guide wire port 204a.

  Next, as shown in FIG. 3, the operator or the like supplies fluid to the lumen 105 of the shaft 100 via the hub 400. The auxiliary expansion part 110 expands toward the guide wire port 204a by the fluid fed into the auxiliary expansion part 110 via the lumen 105 of the shaft 100. Thereby, the auxiliary extension part 110 fixes (holds) the guide wire W to the inner wall of the tip member 200 near the guide wire port 204a.

  As shown in FIG. 4, the balloon 300 starts to expand after the auxiliary expansion portion 110 expands and the guide wire W is fixed to the tip member 200. As described above, in this embodiment, since the constituent material of the auxiliary expansion portion 110 is formed more flexibly than the constituent material of the balloon 300, the auxiliary wire extension portion 110 expands the guide wire W at the distal end. Expansion is started while the member 200 is fixed in the guide wire lumen 205.

  When the balloon 300 is expanded, the guide wire W disposed on the outer surface side of the expansion portion 304 of the balloon 300 is pressed toward the expansion direction of the balloon 300 (outward in the radial direction of the balloon 300). Thereby, the surgeon or the like can expand the stenosis portion S in a state where the scoring function by the guide wire W is added to the balloon 300.

  The surgeon or the like expands the stenosis S using the balloon 300 and the guide wire W, and then discharges the fluid through the lumen 105 of the shaft 100 to contract the auxiliary expansion unit 110 and the balloon 300.

  The auxiliary extension part 110 releases the fixation of the guide wire W as the auxiliary extension part 110 contracts. Further, the balloon 300 releases the pressing of the guide wire W against the stenosis S as the balloon 300 contracts. For this reason, the surgeon or the like can release the scoring function of the balloon 300 and move the balloon 300 alone by contracting the auxiliary expansion portion 110 and the balloon 300. Thereby, the balloon catheter 10 can maintain a softness | flexibility compared with the case where the member which adds a scoring function to the balloon 300 is fixed directly. Therefore, the operator or the like can smoothly move the balloon catheter 10 within the blood vessel.

  Next, the procedure of the procedure using the balloon catheter 10 will be described with reference to FIGS. Here, an example will be described in which the balloon catheter 10 is used for a procedure for expanding a stenosis S formed in a blood vessel B (for example, a coronary artery).

  First, an operator or the like inserts a guide wire W through a stenosis portion S to be treated formed in a blood vessel B as shown in FIG. Note that a surgeon or the like can appropriately use a known introducer (not shown), a guide catheter, or the like when inserting the guide wire W. As the guide wire W, for example, a known penetrating wire used for penetrating a stenosis of a blood vessel can be used.

  Next, the surgeon or the like moves the balloon catheter 10 in the blood vessel B along the guide wire W as shown in FIG. The surgeon or the like adjusts the position of the balloon 300 so that the expanded portion 304 of the balloon 300 is disposed in the stenosis S. An operator or the like can align the balloon 300 with the stenosis S while confirming the positions of the contrast markers 103a and 103b under X-ray contrast.

  Next, as shown in FIG. 6C, the operator or the like supplies fluid to the lumen 105 of the shaft 100 to expand the auxiliary expansion unit 110 (the supply of fluid is indicated by an arrow f1). The auxiliary extension part 110 fixes the guide wire W in the guide wire port 204a of the tip member 200 by expanding.

  As shown in FIG. 7A, the balloon 300 starts to expand after the guide wire W is fixed by the auxiliary extension portion 110 in the guide wire port 204a of the tip member 200. When the balloon 300 is expanded, the guide wire W disposed on the outer surface side of the expanded portion 304 of the balloon 300 is pressed against the narrowed portion S. Thereby, the surgeon or the like can use the guide wire W as a blade, and can efficiently expand the narrowed portion S.

  For example, the surgeon or the like can expand the balloon 300 in a state in which the guide wire W is fixed by the auxiliary expansion unit 110 and the guide wire W is pulled to the proximal end side and tension is applied. is there. Thus, when the balloon 300 is expanded, the surgeon or the like can prevent the position of the guide wire W from being shifted as the balloon 300 is expanded. Thereby, the surgeon or the like can more reliably press the guide wire W against the narrowed portion S when the balloon 300 is expanded.

  After completing the procedure for expanding the stenosis S, the surgeon or the like discharges the fluid from the balloon catheter 10 via the lumen 105 of the shaft 100 (arrowing out the discharge of the fluid as shown in FIG. 7B). indicated by f2). The auxiliary expansion part 110 and the balloon 300 of the balloon catheter 10 contract as the fluid is discharged from the balloon catheter 10. The auxiliary extension part 110 releases the fixation of the guide wire W due to the contraction of the auxiliary extension part 110. Thereby, the surgeon or the like can move the balloon catheter 10 alone along the guide wire W.

  As shown in FIG. 7C, the surgeon or the like contracts the auxiliary expansion portion 110 and the balloon 300 of the balloon catheter 10 and then pulls the balloon catheter 10 out of the living body along the guide wire W. The operator or the like removes the guide wire W as appropriate after removing the balloon catheter 10 from the living body.

  As described above, the balloon catheter 10 according to this embodiment includes the shaft 100 having the lumen 105 into which fluid can be injected, the distal end member 200 disposed at the distal end portion 101 of the shaft 100, the fixed to the shaft 100, and , And a balloon 300 communicating with the lumen 105 of the shaft 100. The tip member 200 has a lumen forming the guide wire lumen 205 and a guide wire port 204 a communicating with the guide wire lumen 205 of the tip member 200, and the shaft 100 is a guide of the tip member 200. It has the front-end | tip opening part 101a opened toward the wire lumen 205, and the auxiliary | assistant extension part 110 which covers the front-end | tip opening part 101a. The constituent material of the auxiliary extension portion 110 is more flexible than the constituent material of the balloon 300, and the auxiliary extension portion 110 is formed by the guide wire lumen 205 of the tip member 200 so as to narrow the guide wire lumen 205 of the tip member 200. It is extensible.

  In the balloon catheter 10 configured as described above, when a fluid is supplied to the lumen 105 of the shaft 100, the auxiliary expansion portion 110 disposed so as to cover the distal end opening portion 101a of the shaft 100 expands. Since the constituent material of the auxiliary expanding portion 110 is more flexible than the constituent material of the balloon 300, the auxiliary expanding portion 110 narrows the guide wire lumen 205 of the tip member 200 before the balloon 300 expands to push and widen the narrowed portion. Extend as follows. The auxiliary extension part 110 fixes the guide wire W inserted through the guide wire lumen 205 when expanded. When the balloon 300 is expanded in a state where the guide wire W is fixed by the auxiliary expanding portion 110, the balloon 300 is pressed against the narrowed portion together with the outer surface of the balloon 300. Thereby, the balloon catheter 10 can expand the stenosis portion in a state where the scoring function is added to the balloon 300 by using the guide wire W instead of the blade. Thus, in the balloon catheter 10, the blade for adding the scoring function is not directly fixed to the balloon 300. Therefore, the balloon catheter 10 does not deteriorate the flexibility of the balloon 300 while the balloon 300 is moving in the blood vessel. For this reason, an operator or the like can smoothly move the balloon catheter 10 in the blood vessel B. In the balloon catheter 10, since the auxiliary expansion portion 110 fixes the guide wire W when the balloon 300 is expanded, the guide wire W moves on the outer surface of the balloon 300 when the balloon 300 expands the narrowed portion. Can be prevented. As a result, the balloon catheter 10 can more reliably press the guide wire W against the stenosis when the balloon 300 is expanded. The stenosis can be expanded.

  Further, the distal end member 200 of the balloon catheter 10 has a tapered portion 204 that is inclined from the proximal end side toward the distal end side. A guide wire port 204 a formed on the tip member 200 is formed on the tapered portion 204 of the tip member 200.

  As described above, since the guide wire port 204a is formed in the tapered portion 204 of the tip member 200, the balloon catheter 10 is formed such that the distance from the tip opening 101a of the shaft 100 to the guide wire port 204a is relatively short. The For this reason, when the auxiliary extension portion 110 disposed at the distal end portion 101 of the shaft 100 is expanded, the guide wire W disposed near the guide wire port 204a of the distal end member 200 can be easily fixed. Furthermore, the balloon catheter 10 has improved insertion (penetration) with respect to the narrowed portion S or the like due to the tapered portion 204 formed in the distal end member 200.

  Further, the distal end portion 101 of the shaft 100 in which the distal end opening portion 101 a is formed is inclined from the proximal end side toward the distal end side in the guide wire lumen 205. The tip opening 101a of the shaft 100 opens toward the guide wire port 204a.

  As described above, the auxiliary extension portion 110 is provided at the distal end portion 101 of the shaft 100 inclined from the proximal end side toward the distal end side, and the distal end opening of the shaft 100 opened toward the guide wire port 204a. Since it arrange | positions so that the part 101a may be covered, when the auxiliary | assistant expansion part 110 expands, the expansion direction is orient | assigned to the guide wire port 204a side. For this reason, the auxiliary extension part 110 can fix the guide wire W arrange | positioned in the guide wire port 204a vicinity more easily and reliably.

  Further, the shaft 100 has a guide wire guiding portion 120 that is disposed on the proximal end side with respect to the balloon 300 and guides the guide wire W to the proximal end side of the shaft 100. An operator or the like can easily guide the guide wire W to the proximal end side of the balloon 300 by using the guide wire guiding portion 120 when the balloon catheter 10 is used. Further, the guide wire guiding part 120 can also prevent the guide wire W from being wrapped around the outer surface of the shaft 100 when the balloon catheter 10 is delivered to the stenosis part.

  Moreover, the auxiliary extension part 110 is comprised so that the guide wire port 204a of the front-end | tip member 200 may be covered in the expanded state. For this reason, the auxiliary extension part 110 can improve the fixing force of the guide wire W with respect to the tip member 200.

  In addition, the constituent material of the tip member 200 is harder than the constituent material of the auxiliary expansion portion 110. For this reason, when the auxiliary expansion part 110 expands, the tip member 200 is prevented from expanding together with the auxiliary expansion part 110. Thereby, the tip member 200 can firmly support the guide wire W with respect to the tip member 200 when the auxiliary extension part 110 is expanded, and the fixing force of the guide wire W to the tip member 200 can be increased. .

Second Embodiment
Next, a balloon catheter (corresponding to a “medical long body”) 500 according to a second embodiment of the present invention will be described.

  In the description of the second embodiment, the description of the same configuration as that already described in the description of the balloon catheter 10 according to the first embodiment will be omitted. Also, points not particularly mentioned in the present embodiment (for example, procedure procedures) can be the same as those in the first embodiment.

  8-12 is a figure which shows the structure of each part of the balloon catheter 500 which concerns on 2nd Embodiment. FIGS. 13 and 14 are cross-sectional views schematically showing the procedure of a procedure example using the balloon catheter 10.

  Specifically, FIG. 8A is a view showing the overall configuration of the balloon catheter 500 (overall view in the state shown in FIG. 10), and FIG. 8B is an enlarged view of the configuration on the distal end side of the balloon catheter 500. FIGS. 9 to 11 are enlarged sectional views showing a state when the auxiliary expansion portion 110 of the balloon catheter 500 and the balloon 300 are expanded, and FIG. 12 (A). FIG. 12 is a front view of the balloon catheter 500 viewed from the direction of the arrow 12A shown in FIG. 9, and FIG. 12B is a cross-sectional view (axial orthogonal cross-sectional view) along the arrow 12B-12B ′ line shown in FIG.

  In FIG. 8, in order to clearly represent the structure of each part of the balloon catheter 500, the size of each part of the balloon catheter 500 is exaggerated with respect to the size (outer diameter) of the guide wire W. Yes.

  The balloon catheter 500 according to the second embodiment is different from the balloon catheter 10 according to the first embodiment in the configuration of the guide wire guiding portion 620.

  In the balloon catheter 10 according to the first embodiment, the guide wire guiding portion 120 is disposed at the same position as the guide wire port 204a (position overlapping in the circumferential direction) with the axis c1 of the shaft 100 as a reference (FIG. 5). (See (A) and FIG. 5 (B)). On the other hand, in the balloon catheter 500 according to the second embodiment, as shown in FIGS. 12 (A) and 12 (B), the guide wire guiding part 620 is guided by the guide wire port 204a with the axis c1 of the shaft 100 as a reference. It is arranged on the opposite side.

  The above-mentioned “arranged on the opposite side” means that the guide wire guiding portion 620 on the axial orthogonal sectional view in the circumferential direction of the shaft 100 indicated by the arrow r shown in FIGS. 12 (A) and 12 (B). It means that there is a phase difference (angle difference) θ close to 180 ° between the center position and the center position of the guide wire port 204a. Note that the phase difference between the guide wire guiding portion 620 and the guide wire port 204a can be appropriately changed as long as a later-described spiral portion Ws can be formed on the guide wire W, and the angle difference θ is strictly 180 °. It is not limited to.

  Except for the arrangement relationship between the guide wire guiding portion 620 and the guide wire port 204a, the balloon catheter 500 according to the second embodiment is configured in substantially the same manner as the balloon catheter 10 according to the first embodiment. For this reason, the description about another structure is abbreviate | omitted.

  Next, the operation procedure of the balloon catheter 500 will be described with reference to FIGS.

  As shown in FIG. 9, when delivering the balloon catheter 10 to the stenosis S in the blood vessel B, the operator or the like inserts the guide wire W through the guide wire lumen 205 of the distal end member 200.

  An operator or the like guides the guide wire W to the proximal end side of the balloon 300 through the outer surface side of the balloon 300 (for example, the outer surface side above the balloon 300 on the axial orthogonal cross section shown in FIG. 12A). . Further, the surgeon or the like inserts the guide wire W through the guide wire guiding portion 620 located on the lower side in the circumferential direction on the axial orthogonal cross section on the proximal side from the balloon 300.

  Next, the operator or the like supplies fluid to the lumen 105 of the shaft 100 via the hub 400. The auxiliary expansion part 110 expands toward the guide wire port 204a by the fluid fed into the auxiliary expansion part 110 via the lumen 105 of the shaft 100. Thereby, the auxiliary extension part 110 fixes (holds) the guide wire W to the inner wall of the tip member 200 near the guide wire port 204a.

  Next, the operator or the like performs an operation of pushing the guide wire W toward the distal end side (the distal end side of the balloon catheter 500) by an operation at hand (see arrow p in FIG. 9). When the guide wire W is pushed toward the distal end side by an operator or the like, the guide wire W is guided by the guide wire guiding portion 620 and wound spirally along the outer periphery of the balloon 300. A portion where the guide wire W is wound forms a spiral portion Ws. The surgeon temporarily stops supplying fluid to the lumen 105 of the shaft 100 when forming the spiral portion Ws in the guide wire W.

  The guide wire W is in a state where the proximal end portion of the guide wire W with respect to the balloon 300 is disposed on the opposite side of the guide wire port 204a with respect to the axis c1 of the shaft 100, and the guide wire W When the portion closer to the distal end than the balloon 300 is pressed in a state of being fixed in the vicinity of the guide wire port 204a, the portion is deformed so as to bend from the distal end side to form a spiral portion Ws spirally wound around the outer periphery of the balloon 300. .

  The surgeon or the like can form the spiral portion Ws over the entire axial direction of the balloon 300 as shown in FIG. 10 by continuing the operation of pushing the guide wire W toward the distal end.

  The surgeon or the like forms a spiral portion Ws having a desired shape on the guide wire W, and then starts supplying fluid to the lumen 105 of the shaft 100 to expand the balloon 300 as shown in FIG. When the balloon 300 is expanded, the guide wire W disposed over substantially the entire circumference of the balloon 300 is pressed toward the expansion direction of the balloon 300 (outward in the radial direction of the balloon 300). Thereby, the surgeon or the like can expand the stenosis S with the scoring function added over substantially the entire circumference of the balloon 300.

  Next, referring to FIGS. 13 and 14, an example procedure of a procedure using the balloon catheter 500 will be described.

  The surgeon or the like places the balloon 300 in the stenosis S formed in the blood vessel B along the guide wire W as shown in FIG.

  Next, as shown in FIG. 13B, the operator or the like supplies a fluid to the lumen 105 of the shaft 100 to expand the auxiliary expansion unit 110 (the supply of the fluid is indicated by an arrow f1). The auxiliary extension part 110 fixes the guide wire W in the guide wire port 204a of the tip member 200 with the extension.

  Next, as shown in FIG. 13C, the surgeon or the like pushes the guide wire W toward the distal end side of the balloon catheter 500 (see arrow p), so that the guide wire W spirals to the outer surface of the balloon 300. A spiral portion Ws wound in a shape is formed.

  Next, as shown in FIG. 14A, the surgeon supplies fluid to the lumen 105 of the shaft 100 to expand the balloon 300 (the supply of fluid is indicated by an arrow f1). The balloon 300 presses the spiral portion Ws of the guide wire W formed over substantially the entire circumference of the outer surface of the expansion portion 304 of the balloon 300 against the narrowed portion S. Thereby, since the surgeon can press the guide wire W along the inner peripheral surface of the stenosis part S, the stenosis part S can be expanded more efficiently.

  In addition, the range (length and position in the axial direction) in which the spiral portion Ws is formed in the guide wire W is not particularly limited as long as the spiral portion Ws overlaps at least a part of the expansion portion 304 of the balloon 300 in the circumferential direction. Absent. Further, since the shape of the spiral portion Ws shown in the drawing (the shape in the state wound around the balloon 300) is an example, the specific shape (number of turns, pitch, etc.) of the spiral portion Ws is limited to the illustrated shape. Never happen.

  After completing the procedure for expanding the stenosis S, the surgeon or the like discharges the fluid from the balloon catheter 10 through the lumen 105 of the shaft 100 as shown in FIG. indicated by f2). The auxiliary expansion part 110 and the balloon 300 of the balloon catheter 10 contract as the fluid is discharged from the balloon catheter 500. The auxiliary extension part 110 releases the fixation of the guide wire W due to the contraction of the auxiliary extension part 110.

  As shown in FIG. 14C, the surgeon or the like contracts the auxiliary expansion portion 110 of the balloon catheter 10 and the balloon 300, and then pulls the guide wire W toward the proximal side, whereby the spiral portion Ws of the guide wire W is obtained. Is eliminated (the state in which the spiral portion Ws is formed on the guide wire W is released). Thereafter, the surgeon or the like removes the balloon catheter 500 from the living body along the guide wire W. The operator or the like removes the guide wire W as appropriate after removing the balloon catheter 500 from the living body.

  The surgeon or the like, for example, after completing the procedure for expanding the stenosis S, maintains the auxiliary expansion unit 110 in an expanded state and deflates the balloon 300, and in this state, the guide wire The spiral portion Ws may be eliminated by pulling W toward the hand side.

  Further, even when the surgeon uses the balloon catheter 500 according to the present embodiment, for example, in consideration of the progress of the symptom of the stenosis S, the spiral wire Ws is not formed on the guide wire W. Alternatively, a treatment for expanding the stenosis S may be performed.

  As described above, in the balloon catheter 500 according to the second embodiment, the guide wire guiding portion 620 is disposed on the side opposite to the guide wire port 204a with respect to the axis c1 of the shaft 100. For this reason, the surgeon pushes the guide wire W toward the distal end side of the balloon catheter 500 in a state where the guide wire W is fixed by the expanded auxiliary expansion portion 110, so that the surgeon substantially extends in the circumferential direction of the balloon 300. A spiral portion Ws of the guide wire W extending in a spiral shape can be formed. Thereby, the surgeon can expand the stenosis S using the balloon catheter 500 more efficiently.

  As mentioned above, although the medical elongate body which concerns on this invention was demonstrated through several embodiment, this invention can be variously modified based on description of a claim, and is limited only to the content of each described embodiment. It will never be done.

  For example, the shape of the tip of the shaft (the shape of the tip opening), the position where the auxiliary extension is arranged, the outer shape of the tip member, the shape and position of the guide wire port, etc. are guided along with the extension of the auxiliary extension. The guide wire inserted through the wire lumen is not limited as long as it can be fixed, and the specific shape, arrangement, and the like can be changed as appropriate.

10, 500 balloon catheter (medical long body),
100 shaft,
101 The tip of the shaft,
101a The opening at the tip of the shaft,
105 shaft lumen,
110 Auxiliary extension,
113 proximal end of the auxiliary extension,
120, 620 guide wire guide,
121 insertion part,
200 tip member,
201 the tip of the tip member,
201a, a tip opening of a tip member,
203, a proximal end portion of the distal end member,
204 taper part,
204a guide wire port,
205 guide wire lumen,
205a lumen,
300 balloons,
301 tip of balloon,
303 proximal end of the balloon,
304 extension,
305 expansion space,
400 hubs,
c1 shaft center,
W guide wire,
Ws spiral,
B blood vessels,
S stenosis,
t1 The inner diameter of the insertion part of the guide wire guiding part,
d1 The inner diameter of the shaft lumen.

Claims (7)

A shaft having a lumen into which fluid can be injected;
A tip member disposed at the tip of the shaft;
A balloon fixed to the shaft and in communication with a lumen of the shaft,
The tip member has a lumen forming a guide wire lumen, and a guide wire port communicating with the lumen of the tip member;
The shaft has a tip opening that opens toward the lumen of the tip member, and an auxiliary extension that covers the tip opening,
The constituent material of the auxiliary expansion part is more flexible than the constituent material of the balloon,
The elongated body for medical use, wherein the auxiliary expansion part is expandable in the lumen of the tip member so as to narrow the guide wire lumen. The distal end member has a tapered portion inclined from the proximal end side toward the distal end side,
The medical elongated body according to claim 1, wherein the guide wire port is formed in the tapered portion. The distal end portion of the shaft in which the distal end opening is formed is inclined from the proximal end side toward the distal end side in the lumen of the distal end member,
The medical elongate body according to claim 1 or 2, wherein the distal end opening portion opens toward the guide wire port side.   The medical length according to any one of claims 1 to 3, wherein the shaft includes a guide wire guiding portion that is disposed on a proximal end side with respect to the balloon and guides a guide wire toward the proximal end side of the shaft. Scale.   The medical long body according to claim 4, wherein the guide wire guiding portion is disposed on the opposite side of the guide wire port with respect to the shaft center of the shaft.   The medical auxiliary body according to any one of claims 1 to 5, wherein the auxiliary extension portion covers the guide wire port in an expanded state.   The medical elongated body according to any one of claims 1 to 6, wherein a constituent material of the tip member is harder than a constituent material of the auxiliary extension portion.