JP2018166922A - Medical long body - Google Patents

Abstract

To provide a medical long body improved in expandability of a narrow section and passability during delivery of the lumen of the living body.SOLUTION: An expansion member 130 included in a medical long body 10 includes a constricted state in which a plurality of blade parts 140 are arranged in a shaft 100 so as to be wound, and an expanded state expanding in the radial direction of the shaft. A linear member 150 has a deformation area 150A forming a protrusion in a natural state in a position in which the linear member is overlapped on the expansion member in the circumferential direction of the expansion member. The deformation area is arranged between the adjacent blade parts of the expansion member while being inhibited from forming a protrusion 155a in a constricted state of the expansion member, and forms a protrusion at an outer surface side of the expansion member due to that the expansion member is expanded in the radial direction in an expanded state of the expansion member.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a medical elongated body including an expansion member that can be expanded in a living body lumen.

  As a medical device for expanding a lesion site such as a stenosis formed in a living body lumen such as a blood vessel, a medical long body called a so-called balloon catheter is known. 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 (expansion member). In general, the blade is made of a resin or metal having rigidity higher than that of the balloon (see, for example, Patent Document 1).

  The scoring balloon catheter can expand the stenosis part while making a cut (crack) 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, the scoring balloon catheter has a particularly high therapeutic effect on the expansion of highly calcified lesions (lesions hardened by calcification).

Special table 2008-504059

  However, the scoring balloon catheter described in Patent Document 1 is always installed such that a relatively rigid blade made of a member different from the balloon has a convex shape on the outer surface of the balloon. For this reason, the above scoring balloon catheter has a problem that the outer diameter of the balloon becomes large during delivery in the living body lumen (when the balloon is deflated), and the passage of the balloon (delivery property) decreases. .

  This invention is made | formed in view of the said subject, and it aims at providing the medical elongate body by which the improvement of the expansibility of a stenosis part and the permeability | transmittance at the time of living body lumen delivery was aimed at.

  A medical elongated body according to the present invention includes a shaft, an expansion member fixed to the distal end portion of the shaft, and is fixed to the distal end side of the shaft or the distal end side of the expansion member, and at least a part thereof is the expansion member. A linear member disposed on the outer surface side of the shaft, wherein the expansion member is in a contracted state in which a plurality of blade portions are wound around the shaft, and in an expanded state in which the shaft is expanded in the radial direction. The linear member has a deformation region that forms a convex portion in a natural state at a position overlapping with the expansion member in a circumferential direction of the expansion member, and the deformation region is a region of the expansion member. In the contracted state, while being inhibited from forming the convex portion, it is disposed between adjacent blade portions of the expansion member, and in the expanded state of the expansion member, the expansion member expands in the radial direction, Previous Forming the protrusions on the outer surface side of the extension member.

  In the medical elongated body according to the present invention, when the stenosis portion is expanded, the linear member forms a convex portion on the outer surface side of the expansion member, so that the expansion force of the expansion member with respect to the stenosis portion is improved. In addition, when the medical elongated body according to the present invention delivers the expansion member to the narrowed portion, the linear member is inhibited from deforming so as not to form a convex portion on the outer surface side of the expansion member. An increase in the outer diameter of the member can be prevented, and the passage through the living body lumen is improved.

It is a figure which shows the medical elongate body which concerns on embodiment of this invention. FIG. 2A is a view showing a cross section in the axial direction of the expanded member in a contracted state, and FIG. 2B is a cross-sectional view along the line 2B-2B shown in FIG. FIG. 3A is a view showing a cross section in the axial direction of the expanded member in an expanded state, and FIG. 3B is a cross-sectional view along the line 3B-3B shown in FIG. FIG. It is a figure which shows the medical elongate body which concerns on the modification 1, FIG. 4 (A) is an axial orthogonal sectional view of the expansion member of the contracted state, and FIG. 4 (B) is the expansion member of the expanded state. FIG. It is a figure which shows the medical elongate body which concerns on the modification 1, and is a figure which shows the cross section of the axial direction of the expansion member of the expanded state. It is a figure which shows the medical elongate body which concerns on the modification 2, FIG. 6 (A) is an axial orthogonal sectional view of the expansion member of the contracted state, and FIG. 6 (B) is the expansion member of the expanded state. FIG. It is a figure which shows the medical elongate body which concerns on the modification 2, and is a figure which shows the cross section of the axial direction of the expansion member of the expanded state. It is a figure which shows the medical elongate body which concerns on the modification 3. FIG.

  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.

  FIG. 1 is a diagram showing the overall configuration of the medical elongated body 10 together with an enlarged cross-sectional view of the proximal end side of the shaft 100, and FIG. 2 (A) is an axial view of the expanded member 130 in a contracted state. 2B is an axial cross-sectional view taken along the line 2B-2B shown in FIG. 2A, FIG. 3A is an axial cross-sectional view of the expanded member 130 in an expanded state, and FIG. (B) is an axial orthogonal cross-sectional view along the arrow 3B-3B line shown in FIG.

  As shown in FIG. 1, the medical elongated body 10 according to the present embodiment has an expansion member (balloon) 130 disposed on the distal end side of the shaft 100 at a lesion site such as a stenosis formed in a body lumen. It is a medical device that expands and treats a lesion site by expanding.

  The medical elongate body 10 is configured as a PTCA treatment balloon catheter used to widen a stenosis of a coronary artery. However, the medical elongate body 10 is, for example, a lesion site such as a stenosis portion formed in a living organ such as another blood vessel, bile duct, trachea, esophagus, other digestive tract, urethra, ear nose lumen, and other organs. It can also be configured as a balloon catheter for the purpose of treatment.

  Hereinafter, with reference to FIGS. 1-3, the medical elongate body 10 which concerns on this embodiment is demonstrated.

  As shown in FIG. 1, the medical elongated body 10 includes a long shaft 100, an expansion member 130 disposed on the distal end side of the shaft 100, and the linear member disposed on the expansion member 130 and the shaft 100. 150, a kink protector 180 disposed on the proximal end side of the shaft 100, and a hub 190 disposed on the proximal end side of the shaft 100 and on the proximal end side of the kink resistant protector 180.

  In the description of the embodiment, the side on which the expansion member 130 is disposed is the distal end side of the medical elongated body 10, the side on which the hub 190 is disposed is the proximal end side of the medical elongated body 10, and the shaft 100 extends. Is the axial direction. Further, in the description of the embodiments, the distal end portion means a certain range including the distal end (the most distal end) and the periphery thereof, and the proximal end portion means a certain range including the proximal end (the most proximal end) and the periphery thereof. Means range.

  As shown in FIG. 1, a medical elongate body 10 is a so-called rapid exchange type catheter in which a proximal end opening (guide wire port) 105 through which a guide wire 200 can enter and exit is formed near the distal end side of a shaft 100. It is configured as.

  As shown in FIG. 2A, the shaft 100 includes an outer tube shaft 110 having a lumen (expansion lumen) 115 and an inner tube shaft 120 having a lumen (guide wire lumen) 125 through which the guide wire 200 is inserted. And have.

  The inner tube shaft 120 is formed of a tubular member (tube member) extending in the axial direction. The base end opening 105 of the shaft 100 shown in FIG. 1 is formed by the base end opening of the inner tube shaft 120.

  The outer tube shaft 110 includes, for example, a distal end shaft and a proximal end shaft that are integrally connected (fused) with the inner tube shaft 120 in the vicinity of the proximal end opening 105 of the shaft 100 (illustration of each shaft is omitted). Can be formed.

  As shown in FIG. 2A, the distal end side of the inner tube shaft 120 is disposed in the lumen 115 of the outer tube shaft 110. A certain range on the distal end side of the inner tube shaft 120 is disposed so as to protrude toward the distal end side of the outer tube shaft 110.

  A distal end member 170 is disposed on the distal end side of the inner tube shaft 120. The distal end member 170 prevents the living organ from being damaged when the distal end of the medical elongated body 10 contacts the living body lumen (such as the inner wall of the blood vessel). The tip member 170 can be formed of a flexible resin material, for example. However, the material of the tip member 170 is not particularly limited as long as it can be fixed to the inner tube shaft 120.

  As shown in FIG. 2 (A), the expansion member 130 is disposed on the distal end side of the expansion main body 131, the expansion main body 131 expanding in the radial direction of the inner pipe shaft 120, and the front end 122 of the inner pipe shaft 120. The distal end side fixing portion 132 to be fixed and the proximal end side fixing portion 133 that is disposed on the proximal end side of the expansion main body portion 131 and is fixed to the distal end 112 of the outer tube shaft 110 are provided.

  Further, the expansion member 130 includes a distal end side tapered portion 134 formed between the distal end side fixing portion 132 of the expansion member 130 and the expansion main body portion 131 of the expansion member 130, and a proximal end fixing portion 133 of the expansion member 130. A proximal-side tapered portion 135 formed between the expansion member 130 and the expansion main body 131.

  The expansion member 130 forms an expansion space 137 communicating with the inner cavity 115 of the outer tube shaft 110 between the outer circumferential surface of the inner tube shaft 120.

  As shown in FIG. 2B, the expansion member 130 forms a contracted state in which a plurality of blade portions 140 are wound around the inner tube shaft 120 in a state where no fluid flows into the expansion space 137. To do.

  The blade portion 140 of the expansion member 130 is formed by arranging the outer surfaces of the expansion member 130 so as to overlap each other in the circumferential direction of the inner tube shaft 120. In this embodiment, as shown in FIG. 2B, the medical elongated body 10 has the expansion member 130 folded so that the three blade portions 140 are formed at different positions in the circumferential direction of the inner tube shaft 120. It is.

  As shown in FIG. 2B, the blade portion 140 of the expansion member 130 forms a predetermined space portion 141 at a position where the outer surfaces of the expansion member 130 face each other. In the space 141, a linear member 150 and a tube member 160 described later are disposed.

  As shown in FIG. 2B, the expansion member 130 has a temporary fixing portion 145 that fixes adjacent blade portions 140 in a contracted state of the expansion member 130.

  The temporary fixing part 145 can be formed by, for example, bonding or fusing part of the blade part 140 of the expansion member 130.

  The fixing of the adjacent blade portions 140 by the temporary fixing portion 145 is maintained in a state where the expansion member 130 is contracted. The linear member 150 and the tube member 160 are disposed in the space portion 141 formed by the blade portion 140 of the expansion member 130 when the expansion member 130 is contracted.

  As shown in FIG. 3B, the fixing of the adjacent blade portions 140 by the temporary fixing portion 145 is released in the expanded state of the expansion member 130. As will be described later, when the fixing of the adjacent blade portions 140 is released, the linear member 150 and the tube member 160 are arranged on the outer surface side of the expansion member 130, and the convex portion 155a is formed by the linear member 150. The

  In addition, as long as the linear member 150 and the tube member 160 can be arranged in the space portion 141, the position where the temporary fixing portion 145 is formed in the blade portion 140, the number of temporary fixing portions 145 formed in one blade portion 140, and the like can be arranged. There is no particular limitation. Further, the position where the linear member 150 and the tube member 160 are arranged in the space 141 is not particularly limited as long as the linear member 150 can form the convex portion 155a when the expansion member 130 is expanded.

  As shown in FIG. 3B, when the fluid flows into the expansion space 137, the expansion member 130 expands in a radial direction that intersects the axial direction of the expansion member 130. The expansion member 130 has a substantially circular cross-sectional shape as shown in FIG. 3B by expanding the blade portion 140 of the expansion member 130 so as to expand in the radial direction.

  In the present embodiment, the state in which the expansion member 130 is expanded means a state in which the expansion member 130 is expanded with the recommended expansion pressure.

  As shown in FIG. 2A, the inner tube shaft 120 includes a contrast marker 129 a indicating a boundary portion between the distal end side tapered portion 134 of the expansion member 130 and the expansion main body portion 131 of the expansion member 130, and the expansion member 130. A contrast marker 129b indicating a boundary portion between the base end side taper portion 135 and the extended main body portion 131. Each contrast marker 129a, 129b can be formed of, for example, a metal such as platinum, gold, silver, iridium, titanium, tungsten, or an alloy thereof. Note that the contrast marker may be disposed at a position indicating a substantially central position in the axial direction of the expansion main body 131 of the expansion member 130.

  As shown in FIG. 1, the hub 190 has a port 191 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 (for example, a contrast medium or physiological saline). doing. The port 191 of the hub 190 can be configured by, for example, a known luer taper configured such that a tube or the like can be connected / separated.

  The kink protector 180 is disposed in the vicinity of the connecting portion between the shaft 100 and the hub 190. The kink protector 180 prevents kinks and the like from being generated on the shaft 100 near the base end of the shaft 100.

  Next, the linear member 150 and the tube member 160 will be described in detail.

  As shown in FIG. 2A and FIG. 3A, the linear member 150 has a deformation region 150A that forms a convex portion 155a in a natural state at a position overlapping the expansion member 130 in the circumferential direction of the expansion member 130. Have.

  As shown in FIG. 2 (B), the deformation region 150A of the linear member 150 is prevented from forming the convex portion 155a in the contracted state of the expansion member 130, while the adjacent blade portion 140 of the expansion member 130 is blocked. It arrange | positions in the space part 141 between.

  As shown in FIG. 3B, the deformation region 150A of the linear member 150 has a convex portion on the outer surface side of the expansion member 130 when the expansion member 130 expands in the radial direction in the expanded state of the expansion member 130. 155a is formed.

  In this embodiment, as shown in FIGS. 2B and 3B, three linear members 150 and three tube members 160 are arranged in the circumferential direction of the expansion member 130. 1, FIG. 2 (A) and FIG. 3 (A), only one linear member 150 and one tube member 160 are illustrated, and the other linear members 150 and the tube member 160 are not shown. .

  As shown in FIG. 3 (A), the deformation region 150A of the linear member 150 includes a coil portion 155 that forms a plurality of convex portions 155a in a natural state. 2A and 2B, the linear member 150 is adjacent to the expansion member 130 in a state where the coil portion 155 is extended in the axial direction when the expansion member 130 is contracted. It arrange | positions between the blade | wing parts 140 which fit.

  The coil portion means a shape or structure in which convex portions having a predetermined shape are continuously formed over a certain range in the axial direction of the expansion member 130 in a natural state (a state where no external force is applied). To do.

  As shown in FIGS. 3A and 3B, the linear member 150 forms a coil portion 155 when the expansion member 130 is in the expanded state. In the present embodiment, the linear member 150 forms a plurality of convex portions 155 a on the outer surface side of the expansion member 130 by forming a coil portion 155 that spirally extends in the axial direction. The linear member 150 is shaped in advance in the deformation region 150A so as to form the spiral coil portion 155 as described above in a natural state. Further, an extension region 150B that is not deformed so as to form the convex portion 155a when the expansion member 130 is expanded and deformed is formed on the proximal end side of the deformation region 150A of the linear member 150. In other words, the extended region 150B is a region where the linear member 150 is not shaped so as to form the convex portion 155a.

  As shown in FIGS. 3A and 3B, in this embodiment, the coil portion 155 formed by the deformation region 150 </ b> A of the linear member 150 has the tube member 160 in the expanded state. A convex portion 155 a is formed on the outer surface side of the expansion member 130 by winding in a circular shape along the inner peripheral surface. Note that the shape of the convex portion 155a formed by the coil portion 155 is not limited to a circular shape, and may be, for example, an elliptical shape, a triangular shape, or other shapes (rectangular shapes) described in a modification example described later. .

  As shown in FIG. 1, the medical long body 10 has a tube member 160 disposed on the outer surface of the expansion member 130 and the outer surface of the shaft 100. As shown in FIG. 2A, the linear member 150 is disposed in the lumen 165 of the tube member 160.

  As shown in FIGS. 2A and 2B, when the expansion member 130 is in the contracted state, the linear member 150 has a convex portion in the deformation region 150A while being accommodated in the lumen 165 of the tube member 160. The deformation is suppressed so that 155a is not formed. Further, in a state where the expansion member 130 is contracted, the deformation region 150A and the extension region 150B of the linear member 150 are restrained in a state where the deformation region 150A that forms the coil portion 155 in the natural state is stretched in the axial direction. Therefore, it extends in the axial direction in a bent state.

  For example, when the deformation region 150A of the linear member 150 forms the convex portion 155a, an extension region that extends in the axial direction along with the deformation of the deformation region 150A is provided on the proximal end side of the extension region 150B. Also good. The extension region is formed by extending on the proximal end side of the extension region 150B when the convex portion 155a is formed in the deformation region 150A of the linear member 150 and the linear member 150 is contracted in the axial direction. Further, the contraction force in the axial direction from the linear member 150 to the tube member 160 is prevented from acting.

  As shown in FIGS. 1 and 2A, the distal end portion 162 of the tube member 160 is disposed near the distal end of the expansion main body portion 131 of the expansion member 130. Further, as shown in FIG. 1, the base end portion 163 of the tube member 160 is disposed in the vicinity of the tip end of the kink protector 180. As shown in FIG. 2A, the tube member 160 may be closed (sealed) at the tip, or an opening may be formed at the tip. Similarly, the tube member 160 may have a proximal end closed or an opening formed at the proximal end.

  The distal end portion 162 of the tube member 160 is fixed to the outer surface of the expansion member 130. Further, the base end portion 163 of the tube member 160 is fixed to the outer surface of the shaft 100. The tube member 160 can be fixed by, for example, fusion or adhesion.

  As shown in FIG. 2A, the distal end portion 152 of the linear member 150 disposed in the lumen 165 of the tube member 160 is disposed in the vicinity of the distal end portion 162 of the tube member 160. Although the base end portion of the linear member 150 is not shown, it is disposed near the base end portion 163 of the tube member 160 (see FIG. 1).

  The linear member 150 is fixed to the distal end side of the expansion member 130 (the distal end side from the proximal end of the expansion main body 131 in the axial direction of the expansion member 130). For example, the distal end portion 153 of the linear member 150 can be fixed to the distal end portion 162 of the tube member 160 disposed on the distal end side of the expansion member 130. Further, for example, the base end portion of the linear member 150 can be fixed to the base end portion 163 of the tube member 160 (see FIG. 1). However, in the linear member 150, at least a part of the linear member 150 may be fixed to the distal end side of the expansion member 130 or the distal end side of the shaft 100, and the position where the linear member 150 is fixed is not particularly limited.

  In addition, when the tube member 160 is not provided in the medical elongate body 10, the linear member 150 may be directly fixed to the expansion member 130 or the shaft 100, or the linear member 150 forms the convex portion 155a. It may be fixed to the expansion member 130 or the shaft 100 via another member that is arranged so as not to hinder.

  As shown in FIG. 3B, for example, when the expansion member 130 is expanded, the linear member 150 and the tube member 160 are arranged at equal intervals in the outer circumferential direction of the expansion member 130. In the present embodiment, the expansion member 130 is provided with three linear members 150 and three tube members 160. For this reason, the linear members 150 and the tube members 160 are arranged such that an equal angular difference of 120 ° is formed between the linear members 150 and the tube members 160 along the outer circumferential direction of the expansion member 130. ing.

  Further, in the present embodiment, the linear member 150 has a proximal end of the inner tube shaft 120 with respect to the shaft center (the shaft center of the inner tube shaft 120) c1 of the shaft 100 in the axis orthogonal cross section shown in FIG. It is arranged at a position different from the opening 105. In FIG. 3B, the direction in which the proximal end opening 105 of the inner tube shaft 120 is located is illustrated by a virtual line.

  The linear member 150 is disposed between the proximal end opening 105 of the inner tube shaft 120 so that the linear member 150 does not overlap the proximal end opening 105 of the inner tube shaft 120 in the outer circumferential direction of the shaft 100 in a state where the expansion member 130 is expanded. Are arranged with a predetermined angular difference (for example, around 45 °). In this embodiment, since three linear members 150 are arranged on the expansion member 130, all the linear members 150 and the proximal end opening 105 of the inner tube shaft 120 do not overlap in the outer peripheral direction of the shaft 100. Each linear member 150 is arranged.

  The arrangement of the linear member 150 is not particularly limited as long as at least a part of the deformation region 150A of the linear member 150 is arranged so as to overlap the expansion main body 131 of the expansion member 130 in the circumferential direction. In addition, the number of linear members 150 arranged on one expansion member 130 is not particularly limited. However, the number of linear members 150 is preferably the same as the number of blade portions 140 formed on the expansion member 130. Thereby, the expansion force with respect to a constriction part improves suitably for the expansion member 130 by the convex part 155a which the linear member 150 forms.

  As shown in FIG. 3B, the linear member 150 is expanded when the expansion member 130 is expanded and the state in which the formation of the convex portion 155a by the blade portion 140 of the expansion member 130 is inhibited (suppressed) is released. The coil portion 155 is formed in the deformation region 150A and spreads in the radial direction in the lumen 165 of the tube member 160. When the linear member 150 forms the coil portion 155, the tube member 160 is expanded in the radial direction by the coil portion 155 and deformed so that its inner diameter and outer diameter are increased. In the linear member 150, when the expansion member 130 is expanded, the tube member 160 is deformed as described above, so that the formation of the coil portion 155 is not hindered, and the convex portion 155a can be smoothly formed in the deformation region 150A.

  As described above, in order to prevent the deformation of the linear member 150 by the tube member 160 when the expansion member 130 is expanded, the tube member 160 is, for example, a natural member 150. It is preferable to form such that the inner diameter and the outer diameter are easily expanded by the force applied in the radial direction in the state.

  As shown in FIG. 3A, the tube member 160 is disposed on the outer surface of the shaft 100 and is positioned on the proximal side of the first region 160A disposed on the outer surface of the expansion member 130 and the first region 160A. Second region 160B.

  As shown in FIG. 3A, the inner diameter of the first region 160A of the tube member 160 is larger than the inner diameter of the second region 160B when the expansion member 130 is in the expanded state. Similarly, the outer diameter of the first region 160A of the tube member 160 is larger than the outer diameter of the second region 160B when the expansion member 130 is in the expanded state.

  As shown in FIG. 3A, the first region 160A of the tube member 160 is disposed at a position overlapping the deformation region 150A of the linear member 150 in the circumferential direction. Further, the second region 160B of the tube member 160 is disposed at a position overlapping with the extending region 150B of the linear member 150 in the circumferential direction.

  As shown in FIG. 2A, the first region 160A of the tube member 160 and the second region 160B of the tube member 160 have substantially the same inner and outer diameters when the expansion member 130 is contracted. .

  As described above, the inner diameter of the first region 160A of the tube member 160 when the expansion member 130 is expanded is the same as that of the second region 160B of the tube member 160 when the expansion member 130 is expanded from the viewpoint of expandability of the narrowed portion. Larger than the inner diameter is preferred. Note that the inner diameter of the first region 160A of the tube member 160 when the expansion member 130 is expanded may be the same as the inner diameter of the second region 160B of the tube member 160 when the expansion member 130 is expanded.

  Next, the constituent material of the medical long body 10 will be described.

  The outer tube shaft 110 is made of, for example, polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, thermoplastic resin such as soft polyvinyl chloride, polyurethane elastomer, polyamide elastomer, polyester elastomer, etc. It can be formed from various elastomers, polyamides, crystalline plastics such as crystalline polyethylene and crystalline polypropylene.

  The inner tube shaft 120 can be formed of, for example, the same material as that exemplified as the constituent material of the outer tube shaft 110.

  The expansion member 130 is, for example, polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyurethane, etc. The thermoplastic resin, polyamide, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber and the like can be used.

  The tube member 160 can be formed of, for example, the same material as that exemplified above as the constituent material of the expansion member 130.

  The linear member 150 can be formed of, for example, a shape memory alloy or a superelastic alloy. As the shape memory alloy and the superelastic alloy, for example, a titanium-based (Ti—Ni, Ti—Pd, Ti—Nb—Sn, etc.) or a copper-based alloy can be used. Further, the linear member 150 can be formed of an alloy having spring properties such as stainless steel (SUS304), β titanium steel, Co—Cr alloy, nickel titanium alloy, and the like. The linear member 150 can also be formed of a shape memory polymer such as acrylic resin, transisoprene polymer, polynorbornene, styrene-butadiene copolymer, polyurethane, and the like.

  Next, the effect | action of the medical elongate body 10 which concerns on this embodiment is demonstrated.

  The medical long body 10 according to the present embodiment includes a shaft 100, an expansion member 130 fixed to the distal end portion of the shaft 100, and a distal end side of the expansion member 130, and at least a part of the medical elongated body 10 is outside the expansion member 130. And a linear member 150 disposed on the surface side. The expansion member 130 has a contracted state in which the plurality of blade portions 140 are wound around the shaft 100 and an expanded state in which the shaft 100 is expanded in the radial direction. Further, the linear member 150 has a deformation region 150 </ b> A that forms the convex portion 155 a in a natural state at a position overlapping the expansion member 130 in the circumferential direction of the expansion member 130. And the deformation | transformation area | region 150A is arrange | positioned between the adjacent blade | wing parts 140 of the expansion member 130, preventing formation of the convex part 155a in the contracted state of the expansion member 130, and in the expansion state of the expansion member 130, As the expansion member 130 expands in the radial direction, a convex portion 155 a is formed on the outer surface side of the expansion member 130.

  In the medical long body 10 according to the present embodiment, when the stenosis portion is expanded, the linear member 150 forms the convex portion 155a on the outer surface side of the expansion member 130, so that the expansion force of the expansion member 130 on the stenosis portion Will improve. Further, the medical elongated body 10 according to the present embodiment is deformed so that the linear member 150 does not form the convex portion 155a on the outer surface side of the expansion member 130 when the expansion member 130 is delivered to the stenosis. Since it is inhibited, it is possible to prevent the outer diameter of the expansion member 130 from increasing, and the passage through the living body lumen is improved.

  In addition, the medical elongated body 10 includes a tube member 160 disposed on the outer surface of the expansion member 130 and the outer surface of the shaft 100, and the linear member 150 is disposed in the inner cavity 165 of the tube member 160. The

  In the medical elongated body 10 configured as described above, since the linear member 150 is disposed in the lumen 165 of the tube member 160, the expansion member 130 expands and the linear member 150 forms a convex portion 155a. In this state, the protrusion 155a can be prevented from being exposed from the tube member 160. For this reason, when the medical long body 10 is expanded from the living body lumen after the expansion member 130 is expanded, the removal of the medical long body 10 is hindered due to the protrusion 155a being caught. Can be prevented. Thereby, an operator such as a doctor can smoothly remove the medical long body 10 from the living body lumen. Furthermore, the linear member 150 forms the convex portion 155a in the inner cavity 165 of the tube member 160, so that the tube member 160 becomes a constricted portion from the inner surface side of the tube member 160 toward the outer surface side of the tube member 160. Since it presses against, the outer surface of the tube member 160 and a constriction part surface-contact, and both contact area becomes large. For this reason, the medical elongate body 10 can apply an equal expansion force over a relatively wide range of the stenosis, and can effectively expand the stenosis.

  In addition, the tube member 160 of the medical elongated body 10 is positioned on the outer surface of the shaft 100 and is positioned on the proximal end side of the first region 160A and the first region 160A disposed on the outer surface of the expansion member 130. And a second region 160B. The inner diameter of the first region 160A is larger than the inner diameter of the second region 160B when the expansion member 130 is expanded.

  When the expansion member 130 expands, the medical elongated body 10 configured as described above has the inner diameter of the first region 160A of the tube member 160 disposed on the outer surface of the expansion member 130 disposed on the outer surface of the shaft 100. The inner diameter of the second region 160B of the tube member 160 becomes larger. For this reason, the linear member 150 can smoothly form the convex portion 155a in the first region 160A of the tube member 160 when the expansion member 130 is expanded. Thereby, when the expansion member 130 expands, the medical elongate body 10 can expand a constriction part efficiently by the expansion member 130 and the convex part 155a.

  The deformation region 150A of the linear member 150 is a coil portion 155 that forms a plurality of convex portions 155a in a natural state, and the linear member 150 has the coil portion 155 in the axial direction in the contracted state of the expansion member 130. In an expanded state, the coil member 155 is disposed between adjacent blade portions 140 of the expansion member 130, and in the expanded state of the expansion member 130, a coil portion 155 is formed on the outer surface side of the expansion member 130.

  In the medical elongated body 10 configured as described above, when the expansion member 130 is expanded, the coil portion 155 that forms the deformation region 150A of the linear member 150 forms a plurality of convex portions 155a. For this reason, the medical elongated body 10 can efficiently apply an expansion force to the narrowed portion from the plurality of convex portions 155a of the linear member 150. Further, the coil portion 155 forming the deformation region 150A of the linear member 150 is disposed between the adjacent blade portions 140 of the expansion member 130 in a state where the expansion member 130 is contracted. For this reason, the medical elongated body 10 can prevent the delivery performance from being lowered by the coil portion 155 in a state where the expansion member 130 is contracted.

  The expansion member 130 has a temporary fixing portion 145 that fixes adjacent blade portions 140 in a contracted state of the expansion member 130, and the fixing of the adjacent blade portions 140 by the temporary fixing portion 145 is performed by the expansion member 130. It is released in the expanded state.

  Since the medical elongate body 10 configured as described above is in a state where the expansion member 130 is contracted, the adjacent blade portions 140 of the expansion member 130 are fixed by the temporary fixing portion 145. When the medical elongated body 10 is delivered to the constriction, it is possible to prevent the blade member 140 of the expansion member 130 from unintentionally spreading and the linear member 150 from forming the convex portion 155a unintentionally. As a result, the surgeon can easily and smoothly deliver the expansion member 130 of the medical elongated body 10 to the stenosis.

  The shaft 100 includes an outer tube shaft 110 and an inner tube shaft 120 disposed in the inner lumen 115 of the outer tube shaft 110. The inner tube shaft 120 has a proximal end opening 105 that opens in the middle of the outer tube shaft 110, and the linear member 150 has a base that is perpendicular to the axis of the shaft 100 in a cross section perpendicular to the axis of the shaft 100. It is arranged at a position different from the end opening 105.

  The medical elongated body 10 configured as described above is not disposed at a position where the proximal end opening 105 of the inner tube shaft 120 and the linear member 150 overlap in the circumferential direction of the shaft 100. For this reason, the medical elongated body 10 can prevent the guide wire 200 from interfering with the linear member 150 when the guide wire 200 is inserted through the proximal end opening 105 of the inner tube shaft 120. The base end opening 105 can be smoothly inserted.

  Next, a modified example of the above-described embodiment will be described. In addition, about the structure and member which are not mentioned especially in each modification, it can be set as the thing similar to embodiment mentioned above, The description is abbreviate | omitted.

<Modification 1>
With reference to FIG. 4 and FIG. 5, the medical elongate body which concerns on the modification 1 is demonstrated.

  4A is an axial orthogonal sectional view showing the expanded member 130 in a contracted state, FIG. 4B is an axial orthogonal sectional view showing the expanded member 130 in an expanded state, and FIG. 5 is an expanded state. FIG. 5 is a cross-sectional view of the expansion member 130 in the axial direction.

  In the above-described embodiment, the coil portion 155 of the linear member 150 is deformed so as to be wound in a circle along the inner peripheral surface of the tube member 160 when the expansion member 130 is expanded to form the convex portion 155a. (See FIGS. 3A and 3B). On the other hand, in the medical elongated body according to this modification, the coil portion 355 forms an elliptical shape in a natural state.

  As shown in FIGS. 4B and 5, the linear member 150 forms a coil portion 355 in the deformation region 150A in a natural state. When the expansion member 130 expands, the coil portion 355 is wound in an elliptical shape along the circumferential direction of the expansion member 130 and the shaft 100.

  As shown in FIGS. 4A and 4B, the tube member 160 has an elliptical cross-sectional shape in accordance with the elliptical shape formed by the coil portion 355. As shown in FIG. 4A, the tube member 160 is disposed in a contracted state between adjacent blade portions 140 of the expansion member 130 when the expansion member 130 is contracted. Further, as shown in FIG. 4B, the tube member 160 expands so that the dimensions of the major axis direction and the minor axis direction of the elliptical shape in the axis-orthogonal cross section are increased in a state where the expansion member 130 is expanded.

  Each linear member 150 and each tube member 160 are arranged such that, in a state where the expansion member 130 is expanded, the elliptical long axis in the axial orthogonal cross section overlaps the perpendicular H1 passing through the axis c1 of the inner tube shaft 120. Is preferred. As a result, the expansion member 130 can be expanded while the end located on the long axis of the elliptical shape on the outer surface side of the expansion member 130 is brought into contact with the stenosis, so that the stenosis can be effectively expanded.

  As described above, in the medical elongated body according to this modification, the coil portion 355 forms the elliptical convex portion 155a in the natural state. For this reason, when the expansion member 130 expands, the medical elongated body can be expanded more efficiently because the convex portion 155a formed by the coil portion 355 improves the expansion force with respect to the narrowed portion.

<Modification 2>
With reference to FIG. 6 and FIG. 7, the medical elongate body which concerns on the modification 2 is demonstrated.

  6A is an axial orthogonal sectional view showing the expanded member 130 in a contracted state, FIG. 6B is an axial orthogonal sectional view showing the expanded member 130 in an expanded state, and FIG. 7 is an expanded state. FIG. 5 is a cross-sectional view of the expansion member 130 in the axial direction.

  As shown in FIGS. 6B and 7, in the medical long body according to this modification, the coil portion 455 forms a triangular shape in a natural state.

  As shown in FIGS. 6B and 7, the linear member 150 forms a coil portion 455 in the deformation region 150A in a natural state. When the expansion member 130 expands, the coil portion 455 is wound in a triangular shape along the circumferential direction of the expansion member 130 and the shaft 100.

  As shown in FIGS. 6A and 6B, the tube member 160 has a triangular shape in the cross section perpendicular to the axis in accordance with the triangular shape formed by the coil portion 455. As shown in FIG. 6A, the tube member 160 is disposed in a contracted state between adjacent blade portions 140 of the expansion member 130 when the expansion member 130 is contracted. Further, as shown in FIG. 6B, the tube member 160 is deformed so as to expand on the outer surface side of the expansion member 130 when the expansion member 130 is expanded.

  Each linear member 150 and each tube member 160 has triangular apexes arranged radially from the axial center of the shaft 100 (axial center of the inner tube shaft 120) c1 in the state where the expansion member 130 is expanded. It is preferably arranged so as to overlap a perpendicular line H1 passing through the axis c1 of the tube shaft 120. Accordingly, the expansion member 130 can be expanded while the apex on the triangle of the coil portion 455 on the outer surface side of the expansion member 130 is in contact with the stenosis portion, so that the stenosis portion can be effectively expanded.

  As described above, in the medical elongated body according to this modification, the coil portion 455 forms the triangular convex portion 155a in the natural state. For this reason, when the expansion member 130 expands, the medical elongated body improves the expansion force with respect to the stenosis portion by pressing the apex portion of the convex portion 155a formed by the coil portion 455 against the stenosis portion. The part can be expanded more efficiently.

<Modification 3>
Hereinafter, with reference to FIG. 8, the medical elongate body 500 which concerns on the modification 3 is demonstrated.

  As shown in FIG. 8, the medical elongated body 500 according to this modification is connected to the hub 190 disposed at the proximal end portion of the shaft 100 and the linear member 150, and can move forward and backward with respect to the hub 190. An operation member 595.

  Although not shown in FIG. 8, the medical elongated body 500 includes three linear members 150 and three tube members 160 at different positions in the circumferential direction of the expansion member 130 as in the above-described embodiment. (See FIG. 2B and FIG. 3B).

  Each of the three linear members 150 is led out from the proximal end opening 163a of the tube member 160 disposed on the distal end side of the kink protector 180 to the proximal end side. The operation member 595 is connected to the linear member 150 led out from each tube member 160. Further, the operation member 595 is formed with an insertion hole 595a that allows the operation member 595 to move forward and backward (moving toward the distal end side and the proximal end side in the axial direction) with respect to the hub 190. The insertion hole 595a prevents the hub 190 and the operation member 595 from interfering with each other by inserting the hub 190 inside the operation member 595 when the operation member 595 moves forward and backward.

  After the expansion member 130 is expanded, the surgeon such as a doctor moves the operation member 595 to the proximal end side when the convex portion 155a formed by the linear member 150 disappears, for example. 150 can be deformed to stretch in the axial direction. As a result, the surgeon can release the state in which the convex portion 155a is formed on the linear member 150, and the medical elongated body 500 can be removed from the living body 500 without the convex portion 155a being formed on the linear member 150. Can be removed from the lumen.

  In addition, when the medical long body 500 is provided with a plurality of linear members 150, a plurality of operation members 595 can be provided so as to be connected to the respective linear members 150, for example. However, as described in the modification, by connecting a plurality of linear members 150 to one operating member 595, the convex portion 155a can be eliminated from the linear member 150 by one operation of the operating member 595. Therefore, when a plurality of linear members 150 are provided, it is preferable to connect all the linear members 150 to one operation member 595.

  As described above, the medical elongated body 500 according to the present modification is connected to the hub 190 disposed at the proximal end portion of the shaft 100 and the linear member 150 and can be moved forward and backward with respect to the hub 190. Member 595.

  The medical elongated body 500 configured as described above moves the operation member 595 to the proximal end side with respect to the hub 190 in a state where the expansion member 130 is expanded and the linear member 150 forms the convex portion 155a. Then, the state in which the linear member 150 is extended toward the proximal end side to form the convex portion 155a can be released. For this reason, an operator such as a doctor can once return the state in which the linear member 150 does not form the convex portion 155a after expanding the expansion member 130, and the medical elongated body 500 is formed by the convex portion 155a. Therefore, even after the expansion member 130 is once expanded, the medical elongated body 500 can be smoothly removed from the living body lumen.

  As mentioned above, although the medical elongate body which concerns on this invention was demonstrated through embodiment and a modification, this invention is not limited only to the structure demonstrated in embodiment and the modification, and description of a claim It is possible to change appropriately based on this.

  Each modification can be combined as appropriate. For example, when a plurality of linear members are provided on one medical elongated body, any one of the linear members described in the embodiments and modifications is combined. Can do. Further, for example, in the configuration shown in the third modification, the linear members exemplified in the first and second modifications can be combined.

  In addition, in the state in which the linear member is expanded, as long as the convex portion is formed on the outer surface side of the expansion member, the cross-sectional shape of the linear member, the thickness of the axis orthogonal cross section (when the axis orthogonal cross section is circular, The outer diameter), the length in the axial direction, the shape formed in the natural state, and the like are not particularly limited. Further, for example, the linear member can be configured by connecting a plurality of linear members. When the linear member is configured in this way, for example, the deformation region and the region (part) other than the deformation region can be configured by separate members.

  Further, in the embodiment and the modification, an example in which a tube member for arranging a linear member on a medical long body is shown, but the linear member is not arranged in the lumen of the tube member, for example, Alternatively, it may be placed directly on the balloon or shaft. In addition, even when the tube member is provided, the medical elongated body is formed in a range where the tube member overlaps at least the outer surface of the expansion member and the outer surface of the shaft in the circumferential direction (position overlapping in the circumferential direction). The outer diameter, inner diameter, axial length, etc. are not particularly limited.

  Further, for example, the medical long body can be configured as an over-the-wire type balloon catheter.

  In addition, for example, the structure of the medical elongated body described in the embodiment, the arrangement of the members, and the like can be changed as appropriate, omission of use of the additional members described by the illustration, and other not specifically described Use of an additional member etc. can also be performed suitably.

10,500 medical long body,
100 shaft,
105 base end opening (base end opening of the inner tube shaft),
110 outer tube shaft,
120 inner tube shaft,
130 expansion member,
140 blades,
141 space,
145 Temporary fixing part,
150 linear members,
150A deformation region of the linear member,
150B Extension region of the linear member,
155, 355, 455 coil part,
155a convex portion,
160 tube member,
160A first region of the tube member;
160B the second region of the tube member;
165 lumen of the tube member,
190 hub,
200 guide wire,
595 operation member,
595a insertion hole,
c1 Shaft axis.

Claims (8)

A shaft,
An expansion member fixed to the tip of the shaft;
A linear member that is fixed to the distal end side of the shaft or the distal end side of the expansion member, and at least a part of the linear member is disposed on the outer surface side of the expansion member,
The expansion member has a contracted state arranged so as to wind a plurality of blade portions around the shaft, and an expanded state expanded in the radial direction of the shaft,
The linear member has a deformation region that forms a convex portion in a natural state at a position overlapping the expansion member in the circumferential direction of the expansion member,
The deformation region is disposed between adjacent blade portions of the expansion member while being inhibited from forming the convex portion in the contracted state of the expansion member, and in the expansion state of the expansion member, the expansion member The medical elongate body which forms the said convex part in the outer surface side of the said expansion member by expanding in a radial direction. A tube member disposed on the outer surface of the expansion member and the outer surface of the shaft;
The medical elongated body according to claim 1, wherein the linear member is disposed in a lumen of the tube member. The tube member has a first region arranged on the outer surface of the expansion member, and a second region located on the proximal end side of the first region and arranged on the outer surface of the shaft,
The medical elongated body according to claim 2, wherein an inner diameter of the first region is larger than an inner diameter of the second region in an expanded state of the expansion member. The deformation region is a coil portion that forms the plurality of convex portions in a natural state,
In the contracted state of the expansion member, the linear member is disposed between the blade portions adjacent to the expansion member, with the coil portion extended in the axial direction, and in the expanded state of the expansion member, The medical elongated body according to any one of claims 1 to 3, wherein the coil portion is formed on an outer surface side of the expansion member.   The said coil part is a medical elongate body of Claim 4 which forms the said elliptical shape or the triangular-shaped convex part in a natural state. A hub disposed at the proximal end of the shaft;
The medical elongated body according to any one of claims 1 to 5, further comprising an operation member connected to the linear member and capable of moving forward and backward with respect to the hub. The expansion member has a temporary fixing portion that fixes adjacent blade portions in the contracted state of the expansion member,
The medical long body according to any one of claims 1 to 6, wherein fixing of the adjacent blade portions by the temporary fixing portion is released in an expanded state of the expansion member. The shaft has an outer tube shaft, and an inner tube shaft disposed in a lumen of the outer tube shaft,
The inner tube shaft has a proximal end opening that opens in the middle of the outer tube shaft,
The said linear member is arrange | positioned in the position different from the said base end opening part with respect to the axial center of the said shaft in the cross section perpendicular | vertical to the axial center of the said shaft. Medical long body.