JP2018033491A - Medical device and treatment method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device and a treatment method capable of maintaining the position of an expansion part for collecting an object at an appropriate position in a living body lumen.SOLUTION: A medical device 1 inserted into a blood vessel for collecting thrombi 300 in the blood vessel includes: a long-sized shaft part 24; an expansion part 20 which is an elastically deformable cylindrical body having a plurality of clearances 21A, whose outer diameter at the central part is larger than the outer diameters at the two end parts of the cylindrical body in a natural state that external force is not applied, and whose proximal part and distal part of the cylindrical body are connected to the shaft part 24; and an elastically deformable auxiliary expansion part 80 connected to the distal part of the expansion part 20, which includes a wire material part 81 extending linearly toward a wire material end part 86 located on the distal side.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a medical device inserted into a living body lumen and a treatment method using the medical device.

  For example, pain or swelling may occur when a part of a vein is clogged with blood clots. For this treatment, there is a method of percutaneously inserting the device and physically crushing and removing the thrombus. In such treatment, there is a risk of pulmonary embolism when a thrombus completely or partially detached from the blood vessel wall reaches the lungs in the bloodstream. For this reason, when such treatment is performed, a thrombolytic agent is used before and / or during the treatment, or the detached thrombus is sucked and removed as much as possible during the treatment. However, even if such a treatment is performed, there is a possibility that an exfoliated thrombus having a clinically problematic size may reach the lung or the like.

  In order to avoid such pulmonary embolism, a method is known in which a filter that collects thrombus flowing in a blood vessel is placed in the blood vessel. For example, Patent Literature 1 describes a device in which an extended portion that extends around a wire and functions as a filter is provided at a distal portion of a long wire.

US Pat. No. 8,562,637

  When a large amount of thrombus is collected by the filter, the filter is clogged and the resistance received from the bloodstream increases. As the resistance received from the bloodstream increases, the filter may flow through the blood vessel.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a medical device and a treatment method that can maintain the position of the expansion unit that collects an object at an appropriate position in a living body lumen. And

  A medical device according to the present invention that achieves the above object is a medical device that is inserted into a living body lumen and collects an object in the living body lumen, and includes a long shaft portion and a plurality of gaps. A cylindrical body that is elastically deformable, has an outer diameter at the center that is larger than the ends on both sides of the cylinder in a natural state where no external force is applied, and a proximal or far portion of the cylinder. Elastically provided with an extension part whose position part is connected to the shaft part and a wire part connected to the distal part of the extension part and extending linearly toward the wire end located on the distal side An auxiliary extension that is deformable.

  A treatment method according to the present invention for achieving the above object is a treatment method for collecting an object in a living body lumen using the above-described medical device, wherein the sheath accommodates the expansion portion and the auxiliary expansion portion. Inserting the expansion part and the auxiliary expansion part from the sheath on the downstream side of the lesioned part in the biological lumen, and making the expansion part and the auxiliary expansion part elastic by themselves. Expanding by force and indwelling the end of the wire rod in the body lumen while making contact with the body lumen tissue, and suppressing the movement of the expansion section in the body lumen by the auxiliary expansion section, A step of collecting an object flowing in the living body lumen by at least the expanding section of the expanding section and the auxiliary expanding section; a step of contracting the expanding section and the auxiliary expanding section; and removing the medical device from the living body lumen It has a step that, a.

  In the medical device and the treatment method configured as described above, since the wire portion of the auxiliary extension portion extends toward the distal end of the wire, the end portion of the wire expands to contact the biological lumen tissue. Thus, a strong resistance against the movement toward the distal side is generated. For this reason, the auxiliary expansion portion and the expansion portion are restrained from moving to the distal side by the resistance force of the auxiliary expansion portion, and can maintain the expansion portion that collects an object at an appropriate position in the living body lumen.

It is a top view which shows the medical device which concerns on embodiment. It is a top view which shows the state which combined the expansion instrument of the medical device which concerns on embodiment, a press shaft, and a sheath. It is a top view which shows the expansion part of an expansion instrument, (A) shows the state which the expansion part expanded, (B) shows the state which the expansion part contracted. It is an expanded sectional view which shows a proximal side connection part and a distal side connection part. It is sectional drawing which follows the AA line of FIG. It is sectional drawing which follows the BB line of FIG. It is sectional drawing which shows the expansion part and closing part in a natural state. It is sectional drawing which shows the expansion part and closed part in a return state. It is sectional drawing which shows the other example of the expansion part in a natural state. It is sectional drawing which shows the other example of the expansion part in the return state. It is a perspective view which shows an auxiliary | assistant expansion part. It is sectional drawing which follows the CC line of FIG. It is a top view which shows a suction device. It is sectional drawing which shows the state in the blood vessel, (A) shows the state at the time of inserting a medical device in the blood vessel, (B) shows the state which expanded the expansion part and the auxiliary expansion part in the blood vessel. It is sectional drawing which shows the state in the blood vessel, (A) shows the state which left the expansion part in the folded state, and has detained in the blood vessel, (B) shows the state which inserted the suction device in the blood vessel. It is sectional drawing which shows the state which was detained in the blood vessel by making the expansion part into a folding state. It is the schematic which shows the dilating instrument in the blood vessel. It is sectional drawing which shows the state in the blood vessel, (A) is the state which expanded the stirring part of the suction device, (B) shows the state at the time of crushing a thrombus etc. by the expanded stirring part. It is sectional drawing which shows the state which collected the crushed thrombus etc. by the expansion part and the closure part. It is sectional drawing which shows the state in the blood vessel, (A) shows the state which accommodated the stirring part in the outer sheath, (B) shows the state which accommodated the expansion part and the auxiliary expansion part in the sheath. It is a top view which shows the modification of a medical device, (A) is a 1st modification, (B) is a 2nd modification, (C) is a 1st modification. It is a top view which shows the modification of a medical device, (A) is a 4th modification, (B) is a 5th modification, (C) is a 6th modification. It is sectional drawing which shows the 7th modification of a medical device. It is a top view which shows the 8th modification of a medical device. It is sectional drawing which shows the 9th modification of a medical device. It is sectional drawing which shows the 10th modification of a medical device.

  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.

  The medical device 1 according to the embodiment of the present invention is used to partially suppress the flow in the blood vessel in order to suck and remove objects such as thrombus, plaque and calcified lesion in the blood vessel. In this specification, the side of the device to be inserted into the blood vessel is referred to as “distal side”, and the proximal side for operation is referred to as “proximal side”. In addition, the object to be removed is not necessarily limited to the plaque or the calcified lesion, and any object that can exist in the living body lumen can be applicable. In this specification, the source side of the blood flow in the blood vessel is referred to as “upstream side”, and the side to which the blood flow is directed is referred to as “downstream side”.

  As shown in FIGS. 1 and 2, the medical device 1 according to the embodiment of the present invention includes an expansion device 10 that restricts blood flow in a blood vessel, a sheath 30 that can store the expansion device 10, and the expansion device 10. And a pressing shaft 40 used for pushing out from the sheath 30. Restricting blood flow is to partially block a cross section perpendicular to the axis of the blood vessel or to reduce the blood flow by reducing the cross section.

  As shown in FIGS. 3 and 4, the expansion device 10 includes an expansion portion 20 that is a net-like cylinder having a plurality of gaps 21 </ b> A, a closing portion 70 disposed on the inner peripheral surface of the expansion portion 20, and the expansion portion 20. A long shaft part 24 connected to the auxiliary part 80 and an auxiliary extension part 80 provided on the distal side of the extension part 20.

  As shown in FIGS. 1 and 3, the shaft portion 24 is a long wire that penetrates the extension portion 20 from the hand and extends to the auxiliary extension portion 80. As shown in FIG. 9, the shaft portion 24 may not penetrate the expansion portion 20, and the distal end portion of the shaft portion 24 may be connected to the proximal side coupling portion 60 of the expansion portion 20. In this case, the auxiliary expansion portion 80 and the distal connection portion 50 of the expansion portion 20 are connected by a connection shaft 23 that is a wire different from the shaft portion 24.

  Although the constituent material of the shaft part 24 is not specifically limited, For example, stainless steel, a shape memory alloy, etc. can be used conveniently.

  As shown in FIG. 3, the extended portion 20 is fixedly connected to a shaft portion 24 and a plurality of flexible deformable linear bodies 21 that are braided in a net shape so as to form a cylindrical body having a gap 21 </ b> A. A distal connection portion 50 and a proximal connection portion 60 slidably connected to the shaft portion 24. The plurality of linear bodies 21 have a gap 21A between the linear bodies 21 by braiding. A membrane-like closing portion 70 is fixed to the proximal portion of the inner peripheral surface of the cylindrical body constituted by the plurality of linear bodies 21. For this reason, in the natural state where no external force acts, the outer diameter of the proximal portion of the expansion portion 20 is larger than the outer diameter of the distal portion due to the influence of the closing portion 70. That is, the extension part 20 has a structure in which the distal part and the proximal part are asymmetric. The part where the closing part 70 of the extension part 20 is not fixed is easier to deform than the part where the closing part 70 of the extension part 20 is fixed. In addition, the extension part 20 may have a structure in which the distal part and the proximal part are symmetrical. The expansion part 20 may not have the closing part 70 fixed thereto.

  As shown in FIGS. 4 and 5, the distal connecting portion 50 includes an inner tube 51 positioned inside the linear body 21 and an outer tube 52 positioned outside the linear body 21. Between the inner tube 51 and the outer tube 52, the distal end portion of the linear body 21 and the shaft portion 24 are sandwiched and fixed. An inner surface side of the inner tube 51 is a guide wire lumen 54 into which a guide wire can be inserted.

  As shown in FIGS. 4 and 6, the proximal connecting portion 60 includes an inner tube 61 positioned inside the linear body 21, an outer tube 62 positioned outside the inner tube 61, and the inner tube 61 and the outer tube. A guide tube 63 sandwiched between 62 is provided. Between the inner tube 61 and the outer tube 62, the proximal end of the linear body 21 and the guide tube 63 are sandwiched and fixed. The shaft portion 24 is slidably disposed inside the guide tube 63. Accordingly, the proximal side connecting portion 60 is movable in the axial direction along the shaft portion 24. An inner surface side of the inner tube 61 is a guide wire lumen 64 into which a guide wire can be inserted.

  The expanded portion 20 is in an expanded state (see FIG. 3A) in which the diameter is expanded by its own elastic force (restoring force) of the linear body 21 in a natural state where no external force is applied. When the extended portion 20 is in the expanded state, the proximal side connecting portion 60 slides distally with respect to the shaft portion 24 and approaches the distal side connecting portion 50. Moreover, the expansion part 20 will be in the contracted state (refer FIG. 3 (B)) which will be elastically deformed and an outer diameter will become small by accommodating in the sheath 30 (refer FIG. 1, 2). When the expansion part 20 is in the contracted state, the proximal side connection part 60 slides proximally with respect to the shaft part 24 and moves away from the distal side connection part 50. By changing the distance between the proximal side connection part 60 and the distal side connection part 50, the outer diameter of the braided expansion part 20 can be changed.

  The expansion part 20 is located between the proximal taper part 20A located on the proximal side, the distal taper part 20C located on the distal side, and the proximal taper part 20A and the distal taper part 20C. And a central portion 20B. The proximal taper portion 20 </ b> A has an inner and outer diameter that increases in a tapered shape from the proximal connection portion 60 toward the distal side. In the distal taper portion 20C, the inner and outer diameters increase in a tapered shape from the distal connection portion 50 toward the proximal side. The inner and outer diameters of the central portion 20B decrease in a tapered shape from the proximal taper portion 20A toward the distal taper portion 20C. The central portion 20B is a portion that contacts the inner wall of the blood vessel when the expansion portion 20 expands. In addition, the site | part which contacts the blood vessel inner wall when the expansion part 20 expands may be 20 A of proximal taper parts, or 20 C of distal taper parts.

  Although the number of the linear bodies 21 is not specifically limited, For example, it is 4-72. Moreover, the conditions for braiding the linear body 21 are not particularly limited. The outer diameter of the linear body 21 can be appropriately selected depending on the material of the linear body 21 and the application of the extended portion 20, and is, for example, 20 to 300 μm.

  The constituent material of the linear body 21 is preferably a flexible material. For example, a shape memory alloy, stainless steel, tantalum (Ta), titanium (Ti), which has a shape memory effect or superelasticity by heat treatment, White silver (Pt), gold (Au), tungsten (W), polyolefins such as polyethylene and polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluorinated polymers such as ETFE (tetrafluoroethylene / ethylene copolymer), PEEK (poly Ether ether ketone), polyimide, and the like can be suitably used. As the shape memory alloy, Ni—Ti, Cu—Al—Ni, Cu—Zn—Al, or a combination thereof is preferably used. Examples of the structure in which a plurality of materials are combined include a structure in which a core wire made of Pt is coated with a Ni—Ti alloy in order to impart contrast, and a structure in which a core wire made of a Ni—Ti alloy is plated with gold. .

  The outer diameter of the outer tubes 52 and 62 is not particularly limited. For example, it is 0.3 to 3.0 mm. The inner diameters of the inner tubes 51 and 61 are not particularly limited. For example, 0.1 to 2.5 mm.

  The constituent materials of the inner tubes 51 and 61 and the outer tubes 52 and 62 are not particularly limited. For example, stainless steel can be suitably used.

  The maximum outer diameter of the expansion part 20 in the expanded state can be appropriately selected according to the inner diameter of the blood vessel to be applied. For example, it is 1 to 40 mm. The outer diameter of the expanded portion 20 in the contracted state can be appropriately selected according to the inner diameter of the blood vessel to be applied. For example, it is 0.3-4.0 mm. The length of the expansion part 20 in the expanded state in the axial direction can be appropriately selected according to the blood vessel to be applied. For example, it is 20-150 mm.

  As shown in FIG. 7, the closing portion 70 is a thin film-like member fixed to the inner peripheral surface on the proximal side of the expansion portion 20. The closing part 70 closes the gap 21 </ b> A of the expansion part 20. The closing part 70 can be flexibly deformed following the extended part 20. The closed portion 70 is arranged in a range equal to or less than half of the axial length of the expanded portion 20 in the expanded state so that the applied blood vessel is not completely blocked in the folded state (see FIG. 8) described later. However, the present invention is not limited to this.

  The constituent material of the closing portion 70 is preferably a flexible material. For example, urethane, natural rubber, silicone resin, or the like can be suitably used. The closing part 70 may be a member having air permeability and liquid permeability. As an example, the closing part 70 is fixed to the extension part 20 by dipping. The closing part may be provided on the outer peripheral surface side of the extension part 20. Further, the closing portion may be provided between the inner peripheral surface and the outer peripheral surface of the expansion portion 20, that is, in the space of the gap 21A. The configuration of the closing portion is not limited as long as the air permeability and liquid permeability of the gap 21 </ b> A can be limited and can be deformed together with the expansion portion 20.

  The thickness of the closing part 70 is not particularly limited. For example, it is 0.005-1.0 mm, Preferably, it is 0.01-0.2 mm.

  When the proximal side coupling part 60 slides distally with respect to the shaft part 24 and approaches the distal side coupling part 50, as shown in FIG. The site on the proximal side of the extension 20 enters. The inside of the extended portion 20 is a region surrounded by the inner surface of the extended portion 20 and the central axis. The inner surface of the extended portion 20 means the inner surface of a cylinder formed by braiding the wire 21. At this time, the linear body 21 located on the distal side of the expansion portion 20 forms a cup-shaped outer portion 22 that opens proximally. The linear body 21 located on the proximal side of the extended portion 20 forms a cup-shaped folding portion 26 that opens to the proximal side on the inner surface side of the outer portion 22. The outer portion 22 and the folding portion 26 are connected by a folding portion 25 that constitutes an end portion on the proximal side of the expansion portion 20. Thereby, the site | part of the proximal side of the expansion part 20 can be located in the inside of a site | part of a distal side, and the expansion part 20 can be in the return state folded by the axial direction.

  When the distal end of the shaft portion 24 is fixed to the proximal connecting portion 60, as shown in FIGS. 9 and 10, when the shaft portion 24 is moved to the distal side, the proximal connecting portion Part 60 is pushed distally by shaft part 24. Thereby, the proximal side connection part 60 approaches the distal side connection part 50, and it can be in the folded state by which the expansion part 20 was folded in the axial direction. At this time, the fixing force of the auxiliary expansion portion 80 to the blood vessel is larger than the force pushed by the shaft portion 24. Thereby, when the proximal side connection part 60 moves to the distal side, the distal side connection part 50 does not move, and the proximal side connection part 60 can approach the distal side connection part 50. As shown in FIGS. 8 and 10, the closing part 70 is disposed on the side where the folding part 26 is provided rather than the folding part 25, that is, on the side closer to the proximal side connecting part 60 (center side). That is, the closing part 70 is arranged only in part in the range from the folded part 25 to the folded part 26. For this reason, the closing part 70 is partially arranged with respect to the expansion part 20 when viewed from the axial direction of the shaft part 24 in the folded state. In the folded state, the maximum outer diameter of the closing portion 70 is smaller than the maximum outer diameter of the expansion portion 20. Thus, the closure 70 partially occludes the applied blood vessel and is not completely occluded. When the blood flowing through the blood vessel reaches the expansion part 20 from the proximal side, it cannot pass through the closing part 70, and therefore the second flow through the first flow path S1 passing through the gap 21A of the folding part 26 or the gap 21A of the folding part 25. From the path S2, the inside of the extension unit 25 is entered. In the folded state, the inside of the extended portion 20 is sandwiched between the outer portion 22 and the folded portion 26. The folded portion 25 is folded so that the wire 21 is dense. For this reason, the gap 21 </ b> A of the folded portion 25 is narrower than the gap 21 </ b> A of the folded portion 26 and the outer side portion 22. The blood that has entered the inside of the expansion part 25 from the first flow path S1 or the second flow path flows in the third direction S3 between the outer side part 22 and the folding part 26 in the distal direction. Thereafter, the blood flows in the distal direction through the fourth flow path S4 between the outer portion 22 and the closing portion 70. The blood flowing through the third flow path S3 and the fourth flow path S4 inside the expansion section 25 passes through the expansion section 20 to the distal side by the fifth flow path S5 passing through the gap 21A of the outer section 22.

  In the folded state, the distance between the proximal side connecting portion 60 and the distal side connecting portion 50 can be set as appropriate. The distance between the proximal connection part 60 and the distal connection part 50 may be different depending on the inner diameter of the blood vessel to be applied. Although the closing part 70 may contact the inner peripheral surface of the distal part of the expansion part 20, it does not need to contact. When the extended portion 20 changes from the expanded state to the folded state, at least a part of the closing portion 70 is turned over. A certain amount of force is required to return the closed portion 70 from the inverted state to the original state (see FIG. 7). For this reason, the extended part 20 and the closing part 70 in the folded state have a certain degree of shape stability.

  In the folded state, the outer surface 22 of the extended portion 20 and the inner surface of the folded portion 26 are in contact with each other and do not overlap. Therefore, the folding part 26 is folded back in a state of being separated from the outer side part 22.

  In the folded state, the expanded portion 20 has a decreasing portion 27 in which the diameter is temporarily decreased from the folded portion 25 toward the proximal side connecting portion 60 located in the expanded portion 20, and an increased diameter in which the diameter is increased from the decreased portion 27. Part 28. As a result, in the folded state, the internal space 29 that is recessed in the axial direction of the extended portion 20 is expanded inside the entrance. In order for the expansion part 20 to return from the folded state to the original state (see FIG. 7), it is necessary for the increase part 28 to pass through the inside of the decrease part 27. For this reason, the extended portion 20 in the folded state has a certain degree of shape stability.

  Moreover, since the expansion part 20 has a larger diameter at the proximal part than at the distal part, the internal space 29 becomes wider in the folded state. For this reason, the space which accommodates objects, such as a thrombus, can be ensured widely.

  As shown in FIGS. 11 and 12, the auxiliary expansion portion 80 includes six wire portions 81 extending to the distal side and a fixing portion 82 to which all the wire portions 81 are fixed. The auxiliary expansion unit 80 exhibits a high fixing force in the blood vessel and can collect an object in the blood vessel. The number of wire parts 81 should just be one or more, and is not limited to six. The fixing portion 82 is a tubular body that surrounds and fixes all the wire portions 81 and the distal end portion of the shaft portion 24. The fixing portion 82 is connected to the distal side connecting portion 50 by the shaft portion 24 or a connecting shaft 23 (see FIG. 9) that is another wire. The connection shaft 23 is a shaft that connects the distal side connection portion 50 and the fixing portion 82 when the shaft portion 24 does not penetrate the expansion portion 20. When the fixing portion 82 and the distal side connecting portion 50 are connected by the connecting shaft 23 different from the shaft portion 24, the extension portion 20 and the auxiliary extension portion 80 can move independently, and the extension portion 20 and the auxiliary extension portion 80 are easily moved. Becomes easier to follow the blood vessel shape. The shaft portion 24 or the connecting shaft 23 is disposed at a position that is separated (biased) in the radial direction from the central axis of the fixed portion 82. It is preferable that the central axis of the fixing portion 82 does not coincide with the central axis of the distal connection portion 50. In the present embodiment, the central axis of the fixing portion 82 is located on the opposite side of the central axis of the distal side connecting portion 50 across the central axis of the shaft portion 24 or the connecting shaft 23. As a result, the guide wire passing through the guide wire lumen 54 of the distal connection portion 50 is less likely to interfere with the fixing portion 82, and the straightness can be maintained, so that the operability is improved. The central axis of the fixing portion 82 may be different from the central axis of the distal side connecting portion 50 even if it is not located on the opposite side of the central axis of the distal side connecting portion 50. The fixing portion 82 is connected to the distal side connecting portion 50 by the shaft portion 24 or the connecting shaft 23. That is, the shaft portion 24 or the connecting shaft 23 between the fixing portion 82 and the distal side connecting portion 50 is the connecting portion 87. The connecting portion 87 has lower bending rigidity than the fixed portion 82 and the distal side connecting portion 50. Furthermore, the connecting portion 87 has a lower bending rigidity than the wire portion 81. For this reason, the connection part 87 can bend flexibly. Accordingly, the connecting portion 87 serves to maintain both the auxiliary expanding portion 80 and the expanding portion 20 in an appropriate position by following the shape of the blood vessel. In addition, since the connecting portion 87 is a part of the shaft portion 24 that passes through the substantial center of the expansion portion 20, the central axes of the auxiliary expansion portion 80 and the expansion portion 20 can be substantially matched. For this reason, the auxiliary expansion part 80 and the expansion part 20 can be appropriately centered within the blood vessel. The connecting portion 87 may be a member different from the shaft portion 24.

  The several wire part 81 is arrange | positioned along with the circumferential direction at equal intervals. The plurality of wire portions 81 are inclined with respect to the central axis of the shaft portion 24 so as to spread toward the distal side in a natural state. The wire portion 81 has a bent portion 83 in which an inclination angle with respect to the central axis of the shaft portion 24 changes. The wire portion 81 has a first wire portion 84 between the fixing portion 82 and the bending portion 83, and has a second wire portion 85 on the distal side of the bending portion 83. The inclination angle θ2 of the second wire rod portion 85 with respect to the central axis of the shaft portion 24 is larger than the inclination angle θ1 of the first wire rod portion 84 with respect to the central axis of the shaft portion 24. Accordingly, the wire portion 81 is bent at the bending portion 83 so that the distal side extends outward in the radial direction. The inclination angle θ1 of the first wire member 84 in the natural state is 0 degree or more and 90 degrees or less, more preferably 2 to 40 degrees, and further preferably 5 to 20 degrees. If the inclination angle θ1 is 90 degrees or less, the first wire portion 84 can generate a strong resistance force to the movement toward the distal side. The inclination angle θ2 of the second wire portion 85 in the natural state is not less than the inclination angle θ1 of the first wire portion 84 and not more than 90 degrees, more preferably 20 to 80 degrees, still more preferably 30 to 50 degrees. . If the inclination angle θ2 is 90 degrees or less, the second wire portion 85 can generate a strong resistance to the movement toward the distal side. The outer diameter of the wire which comprises the 1st wire part 84 and the 2nd wire part 85 is not specifically limited. For example, it is 0.1 to 1.0 mm, preferably 0.2 to 0.7 mm, and more preferably 0.3 to 0.5 mm. The bending rigidity of the wire portion 81 is preferably larger than the bending rigidity of the linear body 21 of the expansion portion 20. Thereby, the wire part 81 can contact a vascular tissue strongly. The length of the 1st wire part 84 is not specifically limited. For example, it is 0.5 to 7.0 mm, preferably 0.5 to 5.0 mm, more preferably 1.0 to 2.0 mm. The length of the 2nd wire rod part 85 is not specifically limited. For example, it is 0.5 to 7.0 mm, preferably 0.5 to 5.0 mm, more preferably 1.0 to 2.0 mm.

  A wire end portion 86 having an outer diameter larger than that of the second wire portion 85 is provided at the distal end of the plurality of wire portions 81. The outer peripheral surface of the wire end portion 86 is a curved surface without corners. The wire end portion 86 is, for example, a sphere. The wire end portion 86 can be easily configured by, for example, heating the distal portion of the second wire portion 85 once to melt it into a spherical shape and then cooling it. Moreover, the wire end part 86 may be comprised by welding, adhere | attaching, etc. another member. Since the wire rod end portion 86 has an outer diameter larger than that of the second wire rod portion 85, it suppresses damage to the blood vessel when contacting the inner wall surface of the blood vessel. The outer diameter of the wire end portion 86 is not particularly limited. For example, it is 0.1 to 3.0 mm, preferably 0.4 to 1.5 mm, and more preferably 0.5 to 1.0 mm.

  The maximum outer diameter of the auxiliary extension portion 80 in the natural state is smaller than the maximum outer diameter of the extension portion 20 in the natural state. Note that the maximum outer diameter of the auxiliary extension portion 80 is the outer diameter of the portion where the wire end portion 86 is located. The expansion part 20 and the auxiliary expansion part 80 are placed in the blood vessel in a state where the outer diameter is smaller than the natural state so as to generate a pressing force on the blood vessel tissue. However, the auxiliary expansion part 80 having higher rigidity than the expansion part 20 has a small decrease in the outer diameter in the blood vessel. Therefore, it is preferable that the auxiliary expansion part 80 is smaller than the maximum outer diameter of the expansion part 20 that can be largely deformed in the blood vessel. The auxiliary expansion part 80 has a larger outer diameter than the expansion part 20 because the auxiliary expansion part 80 has a rigidity higher than that of the expansion part 20 which is deformed and conforms to the blood vessel in a state where the auxiliary expansion part 80 is placed in the blood vessel. For this reason, the auxiliary expansion part 80 can bite into the blood vessel and can be strongly fixed. Note that the maximum outer diameter of the auxiliary extension 80 in the natural state may be equal to or greater than the maximum outer diameter of the extension 20.

  The auxiliary expanded portion 80 is in an expanded state in which the diameter is expanded by its own elastic force (restoring force) of the wire portion 81 in a natural state where no external force acts. In the expanded state, the wire portion 81 spreads radially outward from the center of expansion toward the distal side. Moreover, the auxiliary | assistant expansion part 80 will be in the contracted state which deform | transforms elastically and becomes small outside diameter by accommodating in the sheath 30 (refer FIG. 1, 2). In the contracted state, the bent portion 83 of each wire portion 81 is deformed so as to be substantially linear, and is deformed so that all the wire end portions 86 are gathered at the center. Unlike the shape of the expansion body 20 which has the proximal side taper part 20A, the center part 20B, and the distal side taper part 20C, the auxiliary expansion part 80 is linear. For this reason, the auxiliary expansion part 80 has a larger fixing force with respect to the blood vessel than the expansion part 20.

  The constituent material of the auxiliary extension 80 is preferably a flexible material, for example, stainless steel, tantalum (Ta), titanium (Ti), white silver (Pt), gold (Au), tungsten (W), shape Memory alloys, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE (tetrafluoroethylene / ethylene copolymer), PEEK (polyetheretherketone), and polyimide are preferably used. it can. As the shape memory alloy, Ni—Ti, Cu—Al—Ni, Cu—Zn—Al, or a combination thereof is preferably used. Examples of the structure in which a plurality of materials are combined include a structure in which a core wire made of Pt is coated with a Ni—Ti alloy in order to impart contrast, and a structure in which a core wire made of a Ni—Ti alloy is plated with gold. .

  As shown in FIGS. 1 and 2, the sheath 30 includes a sheath tube body 31, a hub 32, and a kink protector 33. The sheath tube 31 includes a lumen 34 that can accommodate the expansion device 10. The sheath tube 31 has a tube opening 36 at the distal end. The hub 32 is fixed to the proximal end of the sheath tube 31. The hub 32 includes a hub opening 35 that communicates with the lumen 34. The hub opening 35 can connect the Y connector 190 including the side tube 191. By connecting the Y connector 190, the syringe 180 that generates negative pressure can be communicated with the hub opening 35 in a state where a long device (for example, the shaft portion 24) is inserted. Further, by connecting the syringe 180 to the side tube 191 of the Y connector 190, the thrombus dissolving agent can be injected from the syringe 180 into the lumen of the sheath tube 31. The kink protector 33 is a flexible member that covers the connecting portion of the sheath tube 31 and the hub 32. The kink protector 33 suppresses kinking of the sheath tube body 31.

  The constituent material of the sheath tube 31 is not particularly limited. For example, polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, polyvinyl chloride, polystyrene, polyamide, polyimide, or a combination thereof. Etc. can be used suitably. The sheath tube 31 may be composed of a plurality of materials, and a reinforcing member such as a wire may be embedded therein.

  The pressing shaft 40 is a tubular body that can be accommodated in the lumen 34 of the sheath 30. The pressing shaft 40 includes an extrusion lumen 41 into which the shaft portion 24 of the expansion device 10 can be inserted. The inner diameter of the pushing lumen 41 is smaller than the outer diameter of the proximal side connecting portion 60 of the expansion device 10. For this reason, the proximal side connection part 60 cannot enter into the extrusion lumen 41. Therefore, the proximal side connection part 60 can be pressed to the distal side by the distal end face of the pressing shaft 40. Even without the pressing shaft 40, the extension portion 20 and the auxiliary extension portion 80 can be pushed out of the sheath 30 by pushing in the shaft portion 24 itself or pulling the sheath 30 proximally.

  Next, the suction device 100 for inserting into a blood vessel and removing a thrombus will be described.

  As shown in FIG. 13, the suction device 100 includes a long drive shaft 110 that is rotationally driven, a slide portion 111 that is slidable with respect to the drive shaft 110, and a crushing portion 140 that is rotated by the drive shaft 110. It has. The suction device 100 further includes a rotation drive unit 150 including a drive source (for example, a motor) that rotates the drive shaft 110, a guide wire tube 170 into which a guide wire can be inserted, and a guide wire tube 170. And a hub 160 provided at the rear end. The suction device 100 further includes a sheath 30 that can accommodate the drive shaft 110, a Y connector 190 that can be connected to the hub opening 35 of the sheath 30, and a syringe 180 that can be connected to the side tube 191 of the Y connector 190. Yes.

  The drive shaft 110 has a proximal end located at the rotation drive unit 150. The drive shaft 110 can be reciprocated along the circumferential direction by the rotation drive unit 150. However, the drive shaft 110 is not limited to one that reciprocates, and may be one that rotates in one direction.

  The guide wire tube 170 is provided in the hollow interior of the drive shaft 110 from the distal end to the hub 160. The guide wire tube 170 has a guide wire lumen into which a guide wire can be inserted.

  The sheath 30 is a sheath used for the expansion device 10. The sheath 30 is coaxially disposed outside the drive shaft 110. The lumen of the sheath 30 not only accommodates the crushing part 140 but also has a function as a suction lumen that generates a suction force in a negative pressure state. The sheath 30 can rotatably accommodate the drive shaft 110 via the Y connector 190. Further, by connecting the syringe 180 to the side tube 191 of the Y connector 190, the lumen of the sheath 30 can be sucked by the syringe 180 to be in a negative pressure state. In addition, by connecting the syringe 180 to the side tube 191, the thrombolytic agent can be injected from the syringe 180 into the lumen of the sheath 30. The thrombolytic agent that has entered the lumen of the sheath 30 is released from the opening on the distal side of the sheath 30.

  The crushing portion 140 is provided at the distal portion of the drive shaft 110. The crushing unit 140 includes a plurality of (six in this embodiment) wire 141. Each wire 141 is curved three-dimensionally. In addition, the number of the wire 141 is not specifically limited. Each wire 141 is twisted in the same circumferential direction along the axial direction of the drive shaft 110. The proximal end of each wire 141 is fixed to a slide portion 111 that can slide with respect to the wire 141. The distal end portion of each wire 141 is fixed to a fixing portion 112 that is fixed to the drive shaft 110. The fixing position of each wire 141 with respect to the fixing part 112 and the slide part 111 is aligned in the circumferential direction. Further, the substantially central portion in the axial direction in which each wire 141 is curved is aligned in the circumferential direction at a position away from the drive shaft 110 in the radial direction. Thereby, the crushing part 140 has a uniform bulge in the circumferential direction as a whole. When the drive shaft 110 is rotated, the crushing portion 140 is also rotated accordingly, and the thrombus in the blood vessel can be destroyed or the destroyed thrombus can be agitated.

  The wire 141 which comprises the crushing part 140 is comprised by the metal thin wire which has flexibility. Until the drive shaft 110 is inserted into the target site, the crushing part 140 is in a state of being housed in the sheath 30. When the sheath 30 is slid proximally with respect to the drive shaft 110 after the drive shaft 110 is inserted to the target site, the crushing portion 140 is exposed to the outside of the sheath 30 and expands. For this reason, the wire 141 is preferably formed of a material having shape memory properties.

  Next, a method for using the medical device 1 and the suction device 100 according to the present embodiment will be described by taking as an example a case where a thrombus (object) in a blood vessel (biological lumen) is sucked and removed.

  First, an introducer sheath (not shown) is inserted percutaneously into the blood vessel on the upstream side (proximal side) of the blood vessel thrombus 300, and the guide wire 90 is inserted into the blood vessel via the introducer sheath. insert. Next, the guide wire 90 is pushed forward to reach the distal side of the thrombus 300.

  Next, as shown in FIG. 2, the medical device 1 in which the expansion instrument 10 and the pressing shaft 40 are accommodated in the sheath 30 is prepared. A Y connector 190 is connected to the hub 32 of the sheath 30. The expansion part 20 and the auxiliary expansion part 80 are disposed at a position close to the distal end portion of the sheath tube 31 and are constrained in a contracted state. The shaft portion 24 protrudes proximally from the hub opening 35 of the hub 32 through the Y connector 190.

  Next, the proximal end portion of the guide wire 90 located outside the body is inserted into the guide wire lumens 54 and 64 (see FIG. 7) of the medical device 1. Subsequently, as shown in FIG. 14A, the medical device 1 is made to reach the distal side of the thrombus 300 along the guide wire 90. At this time, the central axis of the fixing portion 82 does not coincide with the central axis of the distal connection portion 50 having the guide wire lumen 54. For this reason, the guide wire 90 that passes through the guide wire lumen 54 of the distal connection portion 50 is less likely to interfere with the fixing portion 82, and the operability is high. In addition, in order to make the guide wire 90 reach the distal side of the thrombus 300, a separately prepared support catheter can also be used.

  Next, the sheath 30 is moved proximally while suppressing the movement of the pressing shaft 40 by hand. At this time, the distal end portion of the pressing shaft 40 contacts the proximal side connecting portion 60. Thereby, since the movement of the expansion part 20, the closure part 70, and the auxiliary | assistant expansion part 80 is suppressed, the position of the expansion part 20, the closure part 70, and the auxiliary | assistant expansion part 80 in the blood vessel can be adjusted arbitrarily. And the auxiliary | assistant expansion part 80, the expansion part 20, and the closing part 70 are discharge | released sequentially from the sheath tubular body 31 by the sheath 30 moving to the proximal side with respect to the press shaft 40. FIG. Thereby, as shown in FIG. 14 (B), first, the auxiliary expansion portion 80 expands by its own restoring force, and the plurality of wire portions 81 spread. When the plurality of wire portions 81 spread, the wire end portion 86 located at the end portion of the wire portion 81 contacts the inner wall surface of the blood vessel. At this time, since the wire end portion 86 has an outer diameter larger than that of the wire portion 81 and the surface is a curved surface, damage to the blood vessel can be suppressed. The plurality of wire portions 81 can be greatly expanded by bending the bending portion 83. The wire portion 81 bites into the blood vessel while expanding the blood vessel, and is firmly fixed to the blood vessel. The maximum expandable diameter of the auxiliary extension 80 used is larger than the diameter of the blood vessel to be inserted. For this reason, the auxiliary expansion part 80 will be in the state which does not expand completely within the blood vessel, generates an expansion force, and is effectively fixed to the blood vessel wall.

  When the expansion part 20 and the closing part 70 are released from the sheath tube 31, the distal side connection part 50 moves so as to approach the proximal side connection part 60. And the expansion part 20 expands to an optimal magnitude | size with a self-restoring force, and contacts the inner wall face of the blood vessel. Since the expansion part 20 is formed in a mesh shape, it bites into the inner wall surface of the blood vessel and is firmly fixed. The maximum expandable diameter of the expansion portion 20 to be used is larger than the diameter of the blood vessel to be inserted. For this reason, the expansion part 20 will be in the state which does not expand completely within the blood vessel, generates an expansion force, and is effectively fixed to the blood vessel wall.

  Next, the pressing shaft 40 is moved to the distal side, and the proximal side connecting portion 60 is pushed to the distal side by the distal end portion of the pressing shaft 40. As a result, as shown in FIGS. 15A and 16, the expansion unit 20 is in a folded state folded by the folding unit 25. The closing portion 70 is located on the center side of the folding portion 26 with respect to the folded portion 25, that is, on the side closer to the proximal side connecting portion 60. For this reason, the closed portion 70 does not completely block the blood vessel in the folded state. For this reason, blood flow can be secured and the burden on the living body can be reduced. In the folded state, the maximum outer diameter of the auxiliary extension portion 80 is larger than the maximum outer diameter of the folded portion 25. Further, in the folded state, the maximum outer diameter of the auxiliary extension portion 80 is larger than the maximum outer diameter of the folding portion 26. In the folded state, the maximum outer diameter of the auxiliary extension portion 80 is larger than the maximum outer diameter of the closing portion 70.

  When the extension part 20 is folded back, the extension part 20 receives a force in the distal direction. However, since the auxiliary expansion portion 80 is provided on the distal side of the expansion portion 20, the expansion portion 20 is supported by the auxiliary expansion portion 80 and can maintain an appropriate position. In particular, the bending rigidity of the wire portion 81 of the auxiliary expansion portion 80 is larger than the bending rigidity of the linear body 21 constituting the expansion portion 20. For this reason, the auxiliary expansion part 80 has a larger fixing force with respect to the blood vessel than the expansion part 20. Furthermore, since the wire portion 81 is inclined toward the distal side, it exerts a strong resistance against movement toward the distal side. Furthermore, the wire portion 81 is bent at the bending portion 83. For this reason, if the wire part 81 receives the force to the distal side from the expansion part 20, the bending part 83 will bend and the inclination | tilt angle (theta) 2 (refer FIG. 11) of the 2nd wire part 85 will become large. Thereby, the maximum outer diameter of the auxiliary expansion part 80 becomes large, and the fixing force with respect to the blood vessel of the auxiliary expansion part 80 improves. Therefore, even if the auxiliary extension 80 receives a force in the distal direction from the extension 20, the auxiliary extension 80 hardly moves to the distal side. For this reason, when the extension part 20 is folded back, the position of the extension part 20 can be appropriately maintained and it is easy to fold back. In addition, since the auxiliary expansion part 80 is firmly fixed to the blood vessel as described above even when receiving a strong force from the blood flow by providing the closure part 70, the auxiliary expansion part 80, the expansion part 20 and the closure part 70 are fixed. Can be maintained in an appropriate position.

  Next, the pressing shaft 40 is removed from the living body while leaving the sheath 30. At this time, since the internal space 29 that is recessed in the axial direction of the extended portion 20 is wider than the entrance, the folded state of the extended portion 20 can be stably maintained. Moreover, since the shape of the closing part 70 that is at least partially turned over is stable, the folded state of the extended part 20 can be maintained more stably. Furthermore, since the closed part 70 receives the force which goes to a distal side from a blood flow, the folded-back state of the expansion part 20 can be maintained more stably.

  Moreover, since the expansion part 20 and the auxiliary | assistant expansion part 80 are connected by the flexible connection part 87, each position of the expansion part 20 and the auxiliary | assistant expansion part 80 can be maintained appropriately. Therefore, for example, even if the expansion unit 20 and the auxiliary expansion unit 80 are arranged at a curved portion of the blood vessel, an appropriate position can be maintained according to the shape of the blood vessel.

  As shown in FIG. 17, the expanded portion 20 and the auxiliary expanded portion 80 in the folded state are preferably located closer to the proximal side (lower limb side) than the merged portion of the vena cava 200 with the renal vein 201. The thrombus 300 is located in the iliac vein 202, for example. As a result, the thrombus 301 that falls off the thrombus 300 can be prevented from flowing into the renal vein 201, and an increase in renal pressure or the like can be suppressed to improve safety.

  When the expansion portion 20 and the auxiliary expansion portion 80 are installed on the inner wall surface of the blood vessel, the closing portion 70 partially blocks the blood vessel. Thereby, the blood flow in the blood vessel is reduced. At this time, since the blood vessel is not completely blocked, blood flow can be secured and the burden on the living body can be reduced.

  Next, the proximal end of the shaft portion 24 is inserted into the guide wire lumen of the suction device 100. Next, the distal portion of the drive shaft 110 including the crushing portion 140 is inserted into the Y connector 190 connected to the sheath 30 using the shaft portion 24 as a guide. Subsequently, the drive shaft 110 is pushed forward, and the suction device 100 is inserted into the proximal side of the thrombus 300 as shown in FIG. Thereafter, when the sheath 30 is moved to the proximal side, the crushing portion 140 spreads within the blood vessel as shown in FIGS. 17 and 18A.

  Next, the drive shaft 110 is rotated by the rotation drive unit 130 in a state where the crushing unit 140 has entered the vicinity of the thrombus 300. As a result, as shown in FIG. 18B, the crushing portion 140 rotates and crushes the thrombus 300 that has been fixed in the blood vessel.

  In order to crush the thrombus, when the stirring unit 140 is rotated and moved in the axial direction, a syringe 180 containing a thrombolytic agent can be connected to the side tube 191 on the proximal side of the sheath 30. Then, simultaneously with the destruction of the thrombus 300 by the stirring unit 140, it is possible to push the pusher of the syringe 180 and eject the thrombolytic agent from the distal end portion of the sheath 30. The ejection of the thrombolytic agent may be either continuous or intermittent, and the ejection speed and the ejection amount can be arbitrarily changed. In the case where the thrombolytic agent is ejected intermittently, the thrombolytic agent can be sucked while the ejection is stopped. The thrombolytic agent may not be used. In addition, when the stirring unit 140 is rotated and moved in the axial direction, a suction syringe 180 can be connected to the side tube 191 on the proximal side of the sheath 30. Simultaneously with the destruction of the thrombus 300 by the stirring unit 140, the pusher of the syringe 180 can be pulled to suck the clotted thrombus 301 from the distal end of the sheath 30. It is not necessary to suck the thrombus 301 during crushing.

  The thrombus 301 crushed by the crushing part 140 reaches the expansion part 20 located on the downstream side, as shown in FIGS. The gap 21 </ b> A of the expanded portion 20 in the folded state is partially blocked by the closing portion 70. Therefore, the blood stays in a range that is blocked by the closing portion 70. For this reason, the crushed thrombus 301 becomes a floating state in the staying blood vessel. Then, the blood can pass through the expansion portion 20 through the gap 21 </ b> A that is not closed by the closing portion 70. In the folded portion 25, the extended portion 20 is folded in a state where the inner surfaces are separated without contacting each other. For this reason, the expansion part 20 does not overlap at the folded part 25, and the gap 21A of the expansion part 20 can be secured satisfactorily. Therefore, the blood flowing through the gap 21A of the expansion part 20 can be appropriately maintained, and the burden on the living body can be reduced. In addition, since the inner surfaces of the extended portion 20 do not overlap with each other at the folded portion 25, a wide range of functions as a filter of the extended portion 20 can be secured. That is, when the inner surfaces of the expansion part 20 overlap each other, the expansion part 20 is crushed, and the range in which blood can flow from the outer surface of the expansion part 20 to the inner surface is reduced. On the other hand, it is possible to prevent the gap 21A from being clogged by an object by ensuring a wide range that functions as a filter of the extended portion 20.

  The thrombus 301 that has passed through the gap 21 </ b> A of the expansion portion 20 located outside the closing portion 70 in the folded state enters the inner surface side from the outer surface side of the expansion portion 20. Then, the thrombus 301 is collected on the inner peripheral surface of the expansion part 20 located on the distal side of the folding part 26 in the folded state. By the way, when the inner peripheral surfaces of the expanded portion 20 overlap each other in the folded portion 25, the expanded portion 20 is in a collapsed state, so that when the thrombus 301 passes through the gap 21A, it passes through the two overlapping gaps 21A simultaneously. To do. For this reason, when the inner peripheral surfaces of the expanded portion 20 overlap each other in the folded portion 25, the thrombus 301 that has passed through the gap 21A of the expanded portion 20 from the outer peripheral surface side may not be retained on the inner peripheral surface side of the expanded portion 20. There is sex. On the other hand, since the expansion part 20 is folded in a state where the inner peripheral surfaces are separated from each other in the folded part 25, the thrombus 301 that has passed through the gap 21A of the folded part 25 together with the blood flow from the outer peripheral side is 20 is easily held on the inner peripheral surface side. For this reason, the thrombus 301 can be satisfactorily collected by effectively using both the outer surface and the inner surface of the expanded portion 20 that is doubled by being folded.

  The thrombus 301 that has passed through the double expanded portion 20 by being folded back is further collected by the wire portion 81 that functions as a filter.

  After crushing of the thrombus 300 is completed, the reciprocation and rotation of the drive shaft 110 are stopped. Then, as shown in 20 (B), the crushing part 140 is accommodated in the sheath 30, and the crushing part 140 is pulled out from the sheath 30. The state where the Y connector 190 is connected to the hub 32 of the sheath 30 is maintained.

  Next, the sheath 30 is moved to the distal side along the shaft portion 24. As a result, the sheath 30 is located on the proximal side of the extension 20. Next, the syringe 180 for suction is connected to the Y connector 190, and the pusher of the syringe 180 is pulled to bring the inside of the sheath 30 into a negative pressure state. Thereby, the destroyed thrombus 301 can be sucked from the opening on the distal side of the sheath 30 and discharged to the syringe 180.

  In this embodiment, since the closing part 70 partially restricts the blood flow, the thrombus 301 crushed in the staying blood floats. For this reason, the thrombus 301 can be efficiently aspirated from the sheath 30 and removed from the blood vessel. In addition, when blood is flowing, a strong suction force is required to suck the thrombus 301. In the present embodiment, the closing portion 70 restricts the blood flow. For this reason, it becomes easy to apply the suction force of the sheath 30, and the thrombus 301 can be sucked more effectively. Therefore, the thrombus 301 attached to the site where the closing part 70 of the expansion part 20 is not provided can also be effectively aspirated and removed.

  Further, the closing part 70 is arranged closer to the folding part 26 than the folding part 25. For this reason, the closing part 70 is arrange | positioned in the position corresponding to the internal space 29 hollow in the axial direction of the expansion part 20 in the return state. Therefore, the blood flow in the internal space 29 can be effectively reduced, and the thrombus 301 flowing into the internal space 29 can be well collected. Moreover, the closing part 70 is arrange | positioned at the edge part of the side (proximal side) in which the folding part 26 of the expansion part 20 is located. Accordingly, it is easy to guide the sheath 30 that performs suction to the region (particularly, in the internal space 29) where the closing portion 70 is disposed and the blood is retained using the shaft portion 24 as a guide. For this reason, the thrombus 301 floating in the staying blood can be efficiently aspirated from the sheath 30. In addition, by moving the sheath 30 inside the internal space 29, the thrombus 301 collected at the site where the closing part 70 of the expansion part 20 is not provided can be effectively aspirated.

  Moreover, since the closed part 70 does not completely block the blood vessel in the folded state, the blood flow is secured. For this reason, as shown in FIG. 17, even if the side branch 203 exists in the vicinity of the installation position of the expansion part 20 or the auxiliary expansion part 80, the thrombus 301 does not easily flow into the side branch 203, and safety is improved.

  Then, when the thrombus 300 is crushed and collected by the expansion part 20, the closure part 70 and the auxiliary expansion part 80, and sucked and removed, the expansion part 20, the closure part 70 and the auxiliary expansion part are obtained by the auxiliary expansion part 80. The position of 80 can be maintained appropriately. For this reason, the treatment of collecting and sucking and removing the thrombus 301 can be appropriately performed.

  After the suction of the thrombus 301 by the sheath 30 is completed, as shown in FIG. 20 (B), the sheath 30 is pushed back while reciprocating. At this time, the shaft portion 24 may be pulled proximally. As a result, the proximal side connecting portion 60 moves away from the distal side connecting portion 50 while entering the inside of the sheath 30. The expanded portion 20 and the closed portion 70 are reduced in diameter while returning from the folded state, and are accommodated in the sheath 30. Further, by pushing the sheath 30 to the distal side or pulling the shaft portion 24 to the proximal side, the auxiliary expansion portion 80 is also reduced in diameter and accommodated in the sheath 30. At this time, since the auxiliary expansion part 80 is inclined toward the distal side, it can be smoothly accommodated in the sheath 30. When the expansion part 20, the closing part 70, and the auxiliary expansion part 80 are accommodated in the sheath 30, the thrombus 301 attached thereto can also be accommodated in the sheath 30, so that safety is high.

  After the expansion part 20, the closing part 70, and the auxiliary expansion part 80 are accommodated in the sheath 30, the expansion device 10 is removed from the blood vessel together with the sheath 30 to complete the treatment.

  As described above, the medical device 1 according to this embodiment is a device that is inserted into a blood vessel (biological lumen) and collects the thrombus 301 (object) in the blood vessel, and has a long shaft. The cylinder 24 is elastically deformable with a portion 24 and a plurality of gaps 21A, and has an outer diameter at the center that is larger than the ends on both sides of the cylinder in a natural state where no external force is applied. A proximal portion or a distal portion of the expansion portion 20 is connected to the shaft portion 24, and is connected to the distal portion of the expansion portion 20 and extends linearly toward the wire end portion 86 located on the distal side. And an auxiliary extension portion 80 that includes the wire portion 81 and is elastically deformable. In the medical device 1 configured as described above, since the wire portion 81 extends toward the distal wire end portion 86, the wire end portion 86 of the auxiliary expansion portion 80 comes into contact with the vascular tissue. A strong resistance against movement toward the top side is generated. For this reason, the auxiliary expansion unit 80 and the expansion unit 20 are prevented from moving to the distal side by the resistance force of the auxiliary expansion unit 80, and the expansion unit 20 and the auxiliary expansion unit 80 that collect the thrombus 301 are appropriately disposed in the blood vessel. Can be maintained in the correct position. Moreover, since the extension part 20 is supported by the auxiliary extension part 80, the extension part 20 can be easily turned back.

  Moreover, the auxiliary expansion part 80 has spread radially outward from the center of expansion toward the distal side. Thereby, since the auxiliary expansion part 80 contacts a vascular tissue in the state inclined to the distal side, it can produce strong resistance with respect to the movement to a distal side.

  Moreover, the wire part 81 has the bending part 83 which curves toward the outer side of radial direction from the center of expansion. Accordingly, when the auxiliary expansion portion 80 receives a force from the expansion portion 20 to the distal side in a state where the wire end portion 86 of the auxiliary expansion portion 80 is in contact with the vascular tissue, the maximum outer diameter of the auxiliary expansion portion 80 is increased. The bending part 83 bends in the direction. For this reason, the fixing force with respect to the vascular tissue of the auxiliary expansion part 80 improves.

  Further, the bending rigidity of the wire part 81 is larger than the bending rigidity of the linear body 21 constituting the expansion part 20. Thereby, the auxiliary expansion part 80 can produce strong resistance with respect to the vascular tissue.

  Further, the extended portion 20 and the auxiliary extended portion 80 are connected by a connecting portion 87 having lower bending rigidity than the wire portion 81. Thereby, both the expansion part 20 and the auxiliary expansion part 80 can follow the shape of the blood vessel, and can maintain an appropriate position.

  Further, the central axis of the proximal portion of the auxiliary extension portion 80 is different in position from the central axis of the distal portion of the extension portion 20. Thereby, the guide wire 90 which penetrates the expansion part 20 becomes difficult to interfere with the auxiliary expansion part 80, and operability is high.

  Further, the wire end portion 86 has a larger outer diameter than the wire portion 81 located on the proximal side of the wire end portion 86. Thereby, the wire end part 86 can suppress the damage of the vascular tissue which contacts.

  The present invention also includes a treatment method for collecting the thrombus 301 (object) in the blood vessel (biological lumen) using the medical device 1 described above. The treatment method includes a step of inserting the sheath 30 containing the expansion portion 20 and the auxiliary expansion portion 80 into the blood vessel, and pushes the expansion portion 20 and the auxiliary expansion portion 80 from the sheath 30 on the downstream side of the lesioned portion in the blood vessel. Expanding the expansion portion 20 and the auxiliary expansion portion 80 with their own elastic force and placing the wire end portion 86 in the blood vessel while contacting the blood vessel; and moving the expansion portion 20 in the blood vessel by the auxiliary expansion portion 80 The step of collecting the thrombus 301 flowing in the blood vessel by at least the expansion part 20 of the expansion part 20 and the auxiliary expansion part 80, the step of contracting the expansion part 20 and the auxiliary expansion part 80, and the medical device 1 Removing from the blood vessel. In the treatment method configured as described above, in order to bring the wire end portion 86 of the wire portion 81 extending to the distal side into contact with the blood vessel, the extension portion 20 supported by the auxiliary extension portion 80 is moved to the distal side. It produces a strong resistance against For this reason, the auxiliary expansion unit 80 and the expansion unit 20 are prevented from moving to the distal side by the resistance force of the auxiliary expansion unit 80, and the expansion unit 20 and the auxiliary expansion unit 80 that collect the thrombus 301 are appropriately disposed in the blood vessel. Can be maintained in the correct position.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, although the present embodiment has a structure in which the medical device 1 is accessed from the upstream side of the affected area, the medical device 1 may be accessed from the downstream side of the affected area.

  In this embodiment, the device inserted into the blood vessel along the shaft portion 24 is the suction device 100 including the crushing portion 140. However, if an object can be sucked from the blood vessel, the device to be inserted The configuration is not limited. Further, the device for sucking an object in the blood vessel may be configured separately from the device for dropping the object from the blood vessel. Accordingly, the device that sucks an object in a blood vessel may be a suckable tube that does not include a crushing portion. For example, only the sheath 30 may be a device that sucks an object. Moreover, although the sheath 30 is used in both the medical device 1 and the suction device 100, another sheath may be used in each device.

  Moreover, the biological lumen into which the medical device 1 is inserted is not limited to a blood vessel, and may be, for example, a vascular tube, a ureter, a bile duct, a fallopian tube, a hepatic tube, or the like.

  Further, as in the first modification shown in FIG. 21A, the auxiliary extension 400 may include a guide wire lumen 401 into which a guide wire can be inserted. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to the above-mentioned embodiment, and description is abbreviate | omitted. In this case, it is preferable that the central axis of the guide wire lumen 401 coincides with the central axis of the distal connection part 50 located at the distal part of the expansion part 20. Thereby, it becomes easy to insert the guide wire into both the guide wire lumen 54 of the distal side connecting portion 50 and the guide wire lumen 401 of the auxiliary extension portion 400. And the straightness of a guide wire can be maintained. Therefore, both the auxiliary extension part 400 and the extension part 20 can be smoothly guided to the target position by the guide wire.

  Moreover, like the 2nd modification shown to FIG. 21 (B), the wire part 411 of the auxiliary | assistant expansion part 410 may be linear without having a bending part.

  Further, as in the third modification shown in FIG. 21C, the bent portion 422 of the wire portion 421 of the auxiliary extension portion 420 may be bent in a wide range rather than locally bent.

  Moreover, like the 4th modification shown in FIG. 22 (A), the wire end part 432 of the wire part 431 of the auxiliary | assistant expansion part 430 may have the protrusion part 433 which protrudes. The protrusion 433 has an outer diameter smaller than the outer diameter of the wire end 432. Although it is preferable that the edge part of the protrusion part 433 is sharp, it does not need to be sharp. The protruding portion 433 substantially coincides with the extending direction of the wire portion 431, but may be different. The protruding direction of the protruding portion 433 may have an angle of 0 to 90 degrees, preferably 20 to 80 degrees, more preferably 30 to 50 degrees with respect to the central axis of the auxiliary expanding portion 430 so as to pierce the blood vessel. preferable. Thereby, the auxiliary expansion part 430 can pierce the protrusion part 433 into the inner wall surface of the blood vessel and improve the fixing force. The length of the piercing portion is limited by the wire end portion 432 that has a large outer diameter and does not pierce the blood vessel, thereby ensuring safety.

  Further, as in the fifth modification shown in FIG. 22B, if the wire end portion 442 of the wire portion 441 of the auxiliary extension portion 440 can bite into the blood vessel, the wire portion 441 is bent. It may be a part that curves (or curves). Even with such a wire end 442, the wire end 442 can bite into the blood vessel and obtain a strong fixing force while suppressing damage to the blood vessel.

  Moreover, you may have the some wire part 451 by which the wire end part 452 of the auxiliary | assistant expansion part 450 is arrange | positioned in a position which differs in an axial direction like the 6th modification shown in FIG.22 (C). Since such a wire portion 451 contacts a wide range in the axial direction of the blood vessel, it is difficult to tilt in the blood vessel. For this reason, the auxiliary | assistant expansion part 450 and the expansion part 20 can be maintained in the appropriate position in the blood vessel.

  Further, as in the seventh modification example shown in FIG. 23, the wire end portion 461 of the auxiliary extension portion 460 may not be accommodated in the sheath 30. Then, the surface of the wire end portion 461 may be located on the radially outer side than the outer surface of the sheath 30. This makes it difficult for the distal end of the sheath 30 to contact the blood vessel, and the wire end 461 having a curved surface contacts the blood vessel, thereby reducing damage to the blood vessel.

  Further, as in the eighth modified example shown in FIG. 24, the auxiliary expansion portion 470 may be configured in a net shape by cutting the tubular body like a self-expanding stent. The auxiliary expansion portion 470 is expanded in a natural state where no external force acts. The auxiliary expansion part 470 includes a central part 471 having a constant outer diameter in the expanded state, a distal taper part 472 located on the distal side of the central part 471, and a proximal taper located on the proximal side of the central part 471. Part 473. The distal tapered portion 472 has an outer diameter that decreases in a tapered manner toward the distal side. The proximal tapered portion 473 has an outer diameter that is tapered toward the proximal side. And the wire part 474 is extended to a distal side so that it may continue from the distal part of the center part 471. FIG. The wire part 474 is substantially parallel to the central axis of the auxiliary extension part 470. In the auxiliary expansion portion 470 having such a configuration, the wire portion 474 bites into the blood vessel, and at least the distal end portion of the wire portion 474 penetrates the blood vessel, and is firmly fixed to the blood vessel.

  Moreover, in the above-mentioned embodiment, the proximal side connection part 60 located in the proximal side of the expansion part 20 is slidable with respect to the shaft part 24, and the distal side connection part 50 located in a distal side. Is connected to the shaft portion 24 (see FIG. 8). However, the proximal side coupling portion located on the proximal side of the expansion portion 20 is coupled to the shaft portion 24, and the distal side coupling portion located on the distal side of the expansion portion 20 slides relative to the shaft portion 24. It may be movable. In addition, being connected with the shaft part 24 is not limited to being fixed with respect to the shaft part 24, and includes being connected to be relatively rotatable and movable.

  Further, as in the ninth modification example shown in FIG. 25, not only the proximal side connection part 60 located on the proximal side of the extension part 20 but also the distal side connection part 490 is an axis relative to the shaft part 24. It may be slidable in the direction and rotational direction. The distal side connection part 490 has a lumen 491 through which the shaft part 24 slidably passes. Thereby, the extension part 20 can be easily moved with respect to the auxiliary extension part 480. Therefore, both the expansion part 20 and the auxiliary expansion part 480 can follow the shape of the blood vessel and maintain an appropriate position. Further, the distal connection part 490 and the auxiliary extension part 480 may be engageable (connectable) with each other. For example, the auxiliary extension part 480 may have a tapered convex part 482 that can be fitted to the lumen 491 of the distal connection part 490 at the proximal part of the fixing part 481 to which the shaft part 24 is fixed. When the convex portion 482 enters and fits into the lumen 491, the distal side connection portion 490 and the auxiliary extension portion 480 are engaged. Thereby, the auxiliary extension part 480 can support the extension part 20 favorably.

  Further, as in the tenth modification shown in FIG. 26, the connecting portion 501 that connects the distal side connecting portion 50 and the fixing portion 82 may extend further to the distal side than the fixing portion 82. A distal end tube 502 having a guide wire lumen 503 is disposed on the distal side of the fixing portion 82. The central axis of the guide wire lumen 503 is different from the central axis of the fixed portion 82. The guidewire lumen 503 is preferably in communication with the guidewire lumen 54 of the distal connection 50. The distal end of the connecting portion 50 is fixed to the side surface of the tip tube 502. With such a configuration, by inserting the guide wire into the guide wire lumen 54, the guide wire can be inserted into the guide wire lumen 54 of the distal connecting portion 50, and the operability is improved.

  Moreover, the medical device 1 does not need to be folded back of the expansion unit 20. Moreover, the extended part 20 may be previously shaped so that it may become the shape folded in the natural state. This eliminates the need to fold back the extended portion 20 that is a filter.

  Furthermore, the closing part 70 arrange | positioned at the expansion part 20 does not need to be provided. Thereby, the thrombus 301 crushed by the blood flow is surely collected in the expansion part 20 which is a filter.

1 medical device,
10 expansion device,
20 extensions,
21 linear body,
21A gap,
24 shaft part,
30 sheath,
31 sheath tube,
80, 400, 410, 420, 430, 440, 450, 460, 470, 480 auxiliary extensions,
81, 411, 421, 431, 441, 451, 474 wire part,
82 fixing part,
83, 422 bending part,
84 1st wire part,
85 Second wire rod part,
86, 432, 442, 452, 461 Wire rod end,
87 connecting part,
90 guide wire,
200 vena cava,
201 renal vein,
202 Iliac vein,
300, 301 Thrombus (object),
433 Projection.

Claims (8)

A medical device that is inserted into a body lumen and collects an object in the body lumen,
A long shaft,
A cylindrical body that is elastically deformable with a plurality of gaps, and has an outer diameter at the center that is larger than the ends on both sides of the cylindrical body in a natural state where no external force is applied, and is proximal to the cylindrical body An extension, the portion or distal portion of which is connected to the shaft portion;
A medical device comprising: an auxiliary expansion portion that is coupled to a distal portion of the expansion portion and includes a wire portion that extends linearly toward a wire end portion located on the distal side and is elastically deformable.   The medical device according to claim 1, wherein the auxiliary expansion portion extends radially outward from the center of expansion toward the distal side.   The medical device according to claim 1, wherein the wire portion has a bent portion that bends radially outward from a center of expansion.   The medical device according to any one of claims 1 to 3, wherein the bending rigidity of the wire portion is larger than the bending rigidity of a linear body constituting the expansion portion.   The medical device according to any one of claims 1 to 4, wherein the extension part and the auxiliary extension part are connected by a connection part having lower bending rigidity than the wire part.   The medical device according to claim 1, wherein a central axis of a proximal portion of the auxiliary extension portion is different in position from a central axis of a distal portion of the extension portion.   The medical device according to any one of claims 1 to 6, wherein the wire end portion has an outer diameter larger than that of the wire portion located on the proximal side of the wire end portion. A treatment method for collecting an object in a living body lumen using the medical device according to claim 1, comprising:
Inserting a sheath containing the expansion portion and the auxiliary expansion portion into the biological lumen;
The extension portion and the auxiliary extension portion are pushed out from the sheath on the downstream side of the lesioned portion in the living body lumen, and the extension portion and the auxiliary extension portion are expanded by their own elastic force, so that the end of the wire rod becomes the living body lumen. Indwelling in a body lumen while contacting the tissue;
Collecting an object flowing in a biological lumen by at least the expansion part of the expansion part and the auxiliary expansion part while suppressing movement of the expansion part in the biological lumen by the auxiliary expansion part;
Contracting the extension and the auxiliary extension;
Removing the medical device from within the body lumen.

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