WO2017154749A1

WO2017154749A1 - Medical device

Info

Publication number: WO2017154749A1
Application number: PCT/JP2017/008401
Authority: WO
Inventors: 北岡孝史; 千田高寛; 今井正臣; 増渕雄輝; 金本和明; 加藤幸俊
Original assignee: テルモ株式会社
Priority date: 2016-03-09
Filing date: 2017-03-03
Publication date: 2017-09-14
Also published as: JP2019071914A

Abstract

Provided is a medical device whereby it is possible to suppress a reduction in performance and reduce anisotropy in the bending rigidity of a medical device provided with a plurality of tubes. A medical device (10) having a long shaft outer pipe (21) and a guide wire pipe body (40) arranged beside the shaft outer pipe (21) and connected to the shaft outer pipe (21), wherein the guide wire pipe body (40) has a first tube (41) connected to a distal part of the shaft outer pipe (21), and a second tube (42) connected to the shaft outer pipe (21) at a more proximal location than the first tube (41), bores of the first tube (41) and the second tube (42) being communicated, and the first tube (41) and the second tube (42) being capable of moving relative to each other along the shaft outer pipe (21).

Description

Medical device

The present invention relates to a medical device used by being inserted into a living body lumen.

A medical device to be inserted into a biological lumen such as a blood vessel may be connected with a plurality of tubes side by side. For example, in a catheter inserted into a blood vessel, a tube for distributing a drug, a contrast medium, a physiological saline, or the like, or inserting another device, and a tube for inserting a guide wire are connected side by side. (For example, refer to Patent Document 1). Thus, by providing different tubes according to the purpose, the functions of the tubes do not interfere with each other, and the operability and functions of the catheter can be improved.

US Pat. No. 8,983,582

Since a catheter in which a plurality of tubes are arranged has a difference in the ease of bending of each tube depending on the direction of bending, directionality occurs in the bending rigidity of the entire catheter. For this reason, when a catheter is inserted into a bent biological lumen, the anisotropy of the rigidity of the catheter affects the reachability of the catheter to the lesioned part and the performance of the catheter following the lumen. .

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 that can reduce the anisotropy of bending rigidity of a medical device including a plurality of tubes and can suppress a decrease in performance. And

The medical device according to the present invention that achieves the above object is a medical device having a long main tube and a sub tube connected to the main tube along with the main tube, the sub tube being the main tube A first tube connected to the distal portion of the first tube and a second tube connected to the main tube on a more proximal side than the first tube, the first tube The lumens of the tube and the second tube communicate directly or indirectly through other members, and the first tube and the second tube are relatively movable along the main tube. is there.

In the medical device configured as described above, when the main tube is bent, the first tube and the second tube move relatively along the main tube, so that the anisotropy of the bending rigidity is reduced. For this reason, even if the medical device is inserted into a bent biological lumen, it is possible to suppress a decrease in performance.

It is a top view which shows the medical device which concerns on embodiment. It is a perspective view which shows the distal part of a medical device. It is an expansion perspective view which shows the distal part of a medical device. It is sectional drawing which shows the distal part of a medical device. FIG. 5 is a cross-sectional view showing a shaft outer tube and a guide wire tube It is sectional drawing which shows the state which the outer tube | pipe and the pipe body for guide wires curved. It is sectional drawing which shows the state which the shaft outer tube and the pipe body for guide wires curved in the reverse direction It is sectional drawing which shows the state in the blood vessel, (A) shows the state which inserted the medical device in the blood vessel, (B) shows the state which exposed the crushing part of the medical device in the blood vessel. It is sectional drawing which shows the state which crushed the thrombus with the medical device. It is a perspective view which shows the distal part of a medical device. It is an expanded sectional view of the distal part of a medical device which shows the state where the crushed thrombus was sucked into the opening of the shaft outer tube. It is an expanded sectional view of the distal part of a medical device which shows the process in which the thrombus attracted | sucked to the opening part of the outer shaft tube is cut off by the inner tube. It is an expanded sectional view of the distal part of a medical device which shows the state where the thrombus cut off by the tube in a shaft was cut by the cutting part. It is an expanded sectional view of the distal part of the medical device which shows the process in which the thrombus cut | disconnected by the cutting part is attracted | sucked to the proximal side of the tube in a shaft. It is sectional drawing which shows the modification of a medical device. It is sectional drawing which shows the state which curved the distal part of the modification of the medical device shown in FIG. It is sectional drawing which shows the other modification of a medical device. It is sectional drawing which shows the further another modification of a medical device. It is sectional drawing which shows the further another modification of a medical device. It is sectional drawing which shows the further another modification of a medical device.

Hereinafter, an embodiment of the present invention will be described with reference to the drawings. The medical device 10 according to the present embodiment is inserted into a blood vessel in deep vein thrombosis, and is used for a treatment for crushing and removing the thrombus. In this specification, the side of the device that is inserted into the blood vessel is referred to as the “distal side”, and the proximal side that is operated is referred to as the “proximal side”. Note that the object to be removed is not necessarily limited to the thrombus, and any object that can exist in the living body lumen can be applicable. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

As shown in FIGS. 1 to 4, the medical device 10 includes an elongated shaft portion 20 that is rotationally driven, an outer sheath 90 that can accommodate the shaft portion 20, and a slide portion that is slidable with respect to the shaft portion 20. 50 and a crushing portion 60 that is rotated by the shaft portion 20. The medical device 10 further includes a rotation driving unit 70 that rotates the shaft unit 20, a hub 80 provided at a proximal end portion of the shaft unit 20, and a syringe 100 connected to the proximal side of the hub 80. ing.

The shaft portion 20 includes a long hollow shaft outer tube 21 (main tube), a shaft inner tube 30, and a guide wire tube 40 (sub tube).

The distal end of the shaft outer tube 21 is the distal portion of the shaft portion 20, and the proximal end portion is located in the rotation drive unit 70. The shaft outer tube 21 can be reciprocated along the circumferential direction by the rotation drive unit 70. However, the shaft outer tube 21 is not limited to one that reciprocates, and may be one that rotates in one direction. The shaft outer tube 21 has a lumen 24 that accommodates the shaft inner tube 30 therein. The inner diameter of the shaft outer tube 21 is larger than the outer diameter of the shaft inner tube 30. The shaft outer tube 21 has a long hole-shaped opening 22 in the axial direction in the vicinity of the distal portion, and the inside and outside of the shaft outer tube 21 communicate with each other. A cylindrical contact portion 23 that closes the lumen 24 is provided at the distal end portion of the shaft outer tube 21. The proximal surface of the contact portion 23 is a contact surface 23 </ b> A that faces the distal surface of the shaft inner tube 30. The contact surface 23 </ b> A is located on the distal side of the distal end of the opening 22 of the shaft outer tube 21. The contact part 23 is made of stainless steel or the like.

The shaft inner tube 30 is coaxially stored in the hollow interior of the shaft outer tube 21. The inner shaft tube 30 is movable in the axial direction with respect to the outer shaft tube 21. The distal end portion of the shaft inner tube 30 is located at the proximal end portion of the opening 22 of the shaft outer tube 21 or at the proximal side thereof. The proximal end portion of the shaft inner tube 30 extends further to the proximal side than the proximal end portion of the shaft outer tube 21 and is connected to the hub 80. By connecting the syringe 100 to the hub 80, the hollow inside of the shaft inner tube 30 can be sucked into a negative pressure state. A cutting portion 31 is provided in the hollow interior of the distal end portion of the shaft inner tube 30. The cutting portion 31 is a metal thin plate, has a width corresponding to the diameter of the shaft inner tube 30, and has a sharp blade portion 31A on the distal side.

The distal end face of the blade portion 31A and the distal end face of the shaft inner tube 30 are arranged so that there is no step. For this reason, when the distal surface of the shaft inner tube 30 contacts the contact surface 23A of the contact portion 23, the blade portion 31A also contacts the contact surface 23A. The shaft inner tube 30 is at least from the base side (position shown in FIG. 4) to the contact surface 23A of the contact portion 23 with respect to the shaft outer tube 21, from the base end of the opening portion 22, It can be reciprocated along the axial direction. The cutting part 31 is arranged so as to bisect the cross-sectional shape of the hollow part of the shaft inner tube 30.

The guide wire tube 40 is connected to the shaft outer tube 21 along the outer surface of the distal portion of the shaft outer tube 21. The guide wire tube 40 has a guide wire lumen 44 (lumen) into which a guide wire can be inserted. The guide wire tube 40 includes a third tube provided between the first tube 41 and the second tube 42, the first tube 41 on the most distal side, the second tube 42 on the most proximal side, and the third tube 42. Tube.

The first tube 41 is arranged in parallel with the shaft outer tube 21. The first tube 41 is fixed to the shaft outer tube 21 at the first connecting portion 45 only at the distal portion. For this reason, it can deform | transform independently from the shaft outer tube | pipe 21 except the site | part fixed to the 1st connection part 45 of the 1st tube 41. FIG.

The second tube 42 is arranged in parallel with the shaft outer tube 21 on the proximal side of the first tube 41. The distal end of the second tube 42 is located closer to the proximal side than the proximal end of the first tube 41. The second tube 42 is fixed to the shaft outer tube 21 at the second connecting portion 46 only at the proximal portion. For this reason, it can deform | transform independently from the shaft outer tube | pipe 21 except the site | part fixed to the 2nd connection part 46 of the 2nd tube 42. FIG. The first tube 41 and the second tube 42 have the same inner diameter and outer diameter. Note that the first tube 41 and the second tube 42 may have different inner and outer diameters.

The third tube 43 is located between the first connection portion 45 and the second connection portion 46 and is arranged in parallel with the shaft outer tube 21. The proximal portion of the first tube 41 enters the lumen from the distal opening of the third tube 43. The inner peripheral surface of the third tube 43 is slidable with the outer peripheral surface of the first tube 41. Further, in the third tube 43, the distal portion of the second tube 42 enters the lumen from the opening on the proximal side. The inner peripheral surface of the third tube 43 is slidable with the outer peripheral surface of the second tube 42. The third tube 43 is fixed to the shaft outer tube 21 by a third connecting portion 47 located between the proximal end portion of the first tube 41 and the distal end portion of the second tube 42. ing. The inner diameter of the third tube 43 is slightly larger than the outer diameters of the first tube 41 and the second tube 42. As a result, the first tube 41 and the second tube 42 can slide inside the third tube 43. The third tube 43 has such a length that the first tube 41 and the second tube 42 do not come out of the lumen of the third tube 43 even if the shaft portion 20 is curved. Accordingly, the lumens of the first tube 41, the third tube 43, and the second tube 42 communicate with each other to form one guide wire lumen 44.

The outer peripheral surfaces of the first tube 41 and the second tube 42 are separated from the outer peripheral surface of the shaft outer tube 21 by a gap d that is equal to or greater than the thickness of the third tube 43. For this reason, the third tube 43 is movable between the first tube 41 and the shaft outer tube 21 and between the second tube 42 and the shaft outer tube 21.

The distal portion of the first tube 41 is fixed to the shaft outer tube 21 by the first connecting portion 45. The proximal portion of the second tube 42 is fixed to the shaft outer tube 21 by the second connecting portion 46. Therefore, as shown in FIGS. 5 and 6, when the shaft outer tube 21 is bent from a straight state, the proximal end of the first tube 41 and the distal side of the second tube 42 depend on the degree and direction of the curve. The edge approaches. When the guide wire tube 40 is positioned inside the curve of the curved outer shaft tube 21, the proximal end of the first tube 41 and the distal end of the second tube 42 are closest to each other. . Here, in a straight line that is not curved, the length in which the third tube 43 and the first tube 41 overlap is L5, and the length in which the third tube 43 overlaps the second tube 42 is L6. The lengths L5 and L6 are longer than the uncurved state (see FIG. 5) when the guide wire tube body 40 is positioned inside the curved outer shaft tube 21 (see FIG. 6). In addition, the lengths L5 and L6 are longer than when the guide wire tube body 40 is positioned outside the curve of the curved shaft outer tube 21 (see FIG. 7) and not bent (see FIG. 5). Become. Here, the distance between the axial centers of the shaft outer tube 21 and the guide wire tube 40 is x, the distance between the first connecting portion 45 and the second connecting portion 46 of the shaft outer tube 21 is Lm, and the first tube. The distance between the proximal end portion of 41 and the distal end portion of the second tube 42 is Ld. Further, the minimum allowable radius of curvature of the axis of the shaft outer tube 21 is r, and in the minimum curvature state, a surface orthogonal to the axis of the first connecting portion 45 and a surface orthogonal to the axis of the second connecting portion 46 are present. The angle formed is A degrees. Assuming that the length along the axis of the shaft outer tube 21 does not change when the shaft outer tube 21 is curved, the distance Lm, the first connecting portion 45 along the axis of the guide wire tubular body 40, and the second The length Ls between the connecting portions 46 is as shown in the following formulas (1) and (2).

Lm = 2r · A · π / 180 (1)
Ls = (2r−2x) · A · π / 180 (2)

Therefore, when the shaft outer tube 21 is bent with the minimum radius of curvature r, the reduction amount ΔLs of the length Ls along the axis of the guide wire tube 40 is expressed by the following equation (3).

ΔLs = Lm−Ls = 2x · A · π / 180 (3)

Therefore, even when the shaft portion 20 is curved with the minimum allowable radius of curvature r, the proximal end portion of the first tube 41 and the distal end portion of the second tube 42 do not interfere with each other. In addition, it is preferable to satisfy the following formula (4).
Ld ≧ ΔLs Formula (4)

Further, as shown in FIG. 7, when the guide wire tube body 40 is positioned outside the curve of the curved outer shaft tube 21, the proximal end portion of the first tube 41 and the second tube 42. The distal end is farthest away. In this case, the length Lt between the first connecting portion 45 and the second connecting portion 46 along the axis of the guide wire tubular body 40 is expressed by the following equation (5).

Lt = (2r + 2x) · A · π / 180 Equation (5)

Therefore, when the shaft outer tube 21 is bent with the minimum curvature radius r, the increase amount ΔLt of the length Lt along the axis of the guide wire tube 40 is expressed by the following equation (6).

ΔLt = Lt−Lm = 2x · A · π / 180 (formula 6)

Although depending on the position of the third connecting portion 47 with respect to the third tube 43, at least the following expression (7) is set so that the third tube 43 does not come out of the first tube 41 and the second tube 42. It is preferable to satisfy.

L5 + L6> ΔLt Expression (7)

The shaft outer tube 21 is preferably flexible and capable of transmitting rotational power acting from the proximal side to the distal side. It is preferable that the shaft inner tube 30 is flexible and can transmit the power of the reciprocating motion before and after acting from the proximal side to the distal side. The guide wire tube 40 is preferably flexible. The constituent materials of the shaft outer tube 21, the shaft inner tube 30, and the guide wire tube 40 are not particularly limited. For example, a multilayer coiled tube body such as a three-layer coil in which the right and left and the winding direction are alternated, Polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE (ethylene / tetrafluoroethylene copolymer), PEEK (polyetheretherketone), polyimide, or combinations of these materials It is preferable that the reinforcing member is embedded.

As shown in FIG. 1, the outer sheath 90 can accommodate the shaft portion 20 and can reduce the diameter of the crushing portion 60 connected to the shaft portion 20. The outer sheath 90 is slidable in the axial direction with respect to the shaft portion 20.

Although the constituent material of the outer sheath 90 is not particularly limited, for example, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, PEEK, and polyimide are preferable. Moreover, it may be comprised with several material and reinforcement members, such as a wire, may be embed | buried.

The crushing part 60 is provided in the distal part of the shaft outer tube 21, as shown in FIGS. The crushing part 60 includes a plurality of spiral parts 61. Each spiral portion 61 is twisted in the same circumferential direction along the axial direction of the shaft outer tube 21. A proximal end portion of each spiral portion 61 is fixed to the shaft outer tube 21 by a connecting portion 62. A distal end portion of each spiral portion 61 is fixed to a slide portion 50 that can slide with respect to the shaft portion 20. The fixing positions of the spiral portions 61 with respect to the connecting portion 62 and the slide portion 50 are different in the circumferential direction. Each spiral portion 61 is arranged in the circumferential direction at a position where the central portion in the axial direction of the curve is separated from the shaft outer tube 21 in the radial direction. Thereby, the crushing part 60 has a uniform bulge in the circumferential direction as a whole. If the shaft part 20 rotates, the crushing part 60 will also rotate in connection with it, and the thrombus in the blood vessel can be crushed, or the crushed thrombus can be stirred.

The spiral part 61 which comprises the crushing part 60 is comprised by the metal thin wire which has flexibility. The crushing part 60 is kept in the outer sheath 90 until the shaft part 20 is inserted into the target site. When the spiral portion 61 is accommodated in the outer sheath 90, the slide portion 50 to which the distal portion of the spiral portion 61 is connected is moved to the distal side along the shaft portion 20. Thereby, the spiral part 61 reduces the swelling of the center part along an axial center direction, and approaches the outer peripheral surface of the shaft outer tube | pipe 21. FIG. Accordingly, the spiral portion 61 is reduced in diameter and is accommodated in the outer sheath 90. After inserting the shaft portion 20 to the target site of the blood vessel, the outer sheath 90 is slid proximally with respect to the shaft portion 20, so that the crushing portion 60 is exposed to the outside of the outer sheath 90, and its own elastic force Extend by. At this time, the slide part 50 moves to the proximal side along the shaft part 20. For this reason, it is desirable that the spiral portion 61 is made of a material having shape memory properties. As the constituent material of the spiral portion 61, for example, a shape memory alloy, stainless steel, or the like to which a shape memory effect or superelasticity is imparted by heat treatment is suitable. As the shape memory alloy, Ni—Ti, Cu—Al—Ni, Cu—Zn—Al, a combination thereof, or the like is preferable.

The slide part 50 has a C-shaped cross section perpendicular to the axial direction of the shaft part 20. The slide portion 50 has a slit 58 that extends from the first end portion to the second end portion of the slide portion 50 in the axial direction. The slit 58 accommodates the guide wire tube 40. Accordingly, the distal portion of the spiral portion 61 is fixed to the slide portion 50, and the slide portion 50 can slide in the axial direction without rotating with respect to the outer peripheral surface of the shaft outer tube 21.

The constituent material of the slide portion 50 is not particularly limited as long as the shape can be maintained. For example, polyolefin such as stainless steel, aluminum, polyethylene, and polypropylene, polyester such as polyamide and polyethylene terephthalate, fluorine-based polymer such as ETFE, PEEK, polyimide, Etc. are suitable.

As shown in FIG. 1, the rotary drive unit 70 includes a drive motor 71 and a gear unit 72 that links the drive motor 71 with the shaft outer tube 21 of the shaft unit 20. By rotating the drive motor 71, the shaft outer tube 21 rotates in the circumferential direction. In this embodiment, the shaft outer tube 21 is driven by the drive motor 71 so as to rotate alternately in two directions of positive and negative in the circumferential direction. By alternately rotating in the positive and negative directions, the blood flow can alternately turn in the opposite direction.

Next, a method of using the medical device 10 according to the present embodiment will be described by taking as an example a case where a thrombus in a blood vessel is crushed and sucked.

Before inserting the shaft portion 20 of the medical device 10 of the present embodiment, a protective member such as a filter or a balloon that restricts the flow of fluid in the blood vessel is disposed downstream of the thrombus in the blood vessel (the side where the blood flow is directed). It is desirable to keep it. In this embodiment, as shown in FIG. 8 (A), an elastic body 111 made of a wire that expands by its own elastic force by being pushed out from a sheath or the like, and a film-like film disposed on the outer peripheral surface of the elastic body 111 A filter device 110 including a filter 112 and a wire portion 113 connected to the elastic body 111 is used. When the elastic body 111 pushed out from the sheath or the like expands and the filter 112 comes into contact with the blood vessel, the filter 112 restricts blood circulation. Thereby, the crushed thrombus can be prevented from flowing through the blood vessel and moving to another location.

Next, the medical device 10 in a state in which the distal portion of the shaft portion 20 including the crushing portion 60 is accommodated in the outer sheath 90 is prepared. Next, the proximal end portion of the wire portion 113 is inserted into the guide wire lumen 44 (see FIG. 4) of the medical device 10. Next, the medical device 10 is made to reach the proximal side of the thrombus 300 using the wire portion 113 as a guide. Thereafter, when the outer sheath 90 is moved proximally with respect to the shaft portion 20, as shown in FIG. 8B, the crushing portion 60 is exposed to the outside of the outer sheath 90 and is expanded by its own elastic force. To do. At this time, the slide part 50 moves to the proximal side with respect to the shaft part 20.

Next, when the crushing part 60 has entered the vicinity of the thrombus 300 and the rotation driving part 70 (see FIG. 1) rotates the shaft outer tube 21, the crushing part 60 also rotates accordingly. When the crushing part 60 is moved to the distal side in this state, the crushing part 60 comes into contact with the thrombus 300, and the crushing part 60 crushes in a state where the crushing part 60 is fixed in the blood vessel. If the crushing unit 60 continues to rotate, the blood flow is restricted by the filter device 110, and therefore, as shown in FIG. 9, the thrombus 300 fixed in the blood vessel is crushed. The crushed thrombus 301 is in a floating state without being settled in the staying blood vessel.

When the crushing part 60 contacts the thrombus 300 by rotating, it receives a reaction force in the direction opposite to the rotating direction. A proximal portion of the crushing portion 60 is fixed to the shaft portion 20 by a connecting portion 62. Further, the distal portion of the crushing portion 60 is connected to the slide portion 50, and the slide portion 50 is restricted from rotating relative to the shaft portion 20. For this reason, in the crushing portion 60, relative rotation of the proximal end portion and the distal end portion is limited, and twisting is suppressed. For this reason, the swelling of the crushing part 60 can be maintained at a desired size, and the range in which the thrombus can be crushed can be appropriately maintained.

Then, when the blood vessel in which the thrombus 300 exists is curved, the shaft portion 20 rotates in a curved state along the blood vessel. At this time, as shown in FIGS. 6 and 7, the guide wire tube 40 swings around the shaft outer tube 21 that is rotationally driven. At this time, the guide wire tube 40 maintains the guide wire lumen 44, and the third tube 43 slides in the axial direction with respect to the first tube 41 and the second tube 42 as it rotates. The contraction or extension is repeated in the axial direction. For this reason, the bending rigidity of the shaft portion 20 including the shaft outer tube 21 and the guide wire tube 40 is compared with the case where the entire axial direction of the guide wire tube is fixed to the shaft outer tube 21. Low anisotropy due to bending direction. Therefore, even in the curved blood vessel, since the shaft portion 20 rotates smoothly, the crushing portion 60 does not swing more than necessary, and the cutting property of the thrombus 300 can be maintained well.

Further, when the crushing portion 60 comes into contact with the thrombus 300, the shaft portion 20 including the shaft outer tube 21 and the guide wire tubular body 40 is twisted, as indicated by a dashed line in FIG. When the shaft outer tube 21 is twisted, the guide wire tube 40 is deformed so as to draw a spiral along the outer periphery of the shaft outer tube 21, and the entire length becomes longer. On the other hand, when the first tube 41 and the second tube 42 cannot move relatively in the axial direction, the guide wire tubular body 40 is difficult to extend and contract in the axial direction. For this reason, the shaft outer tube 21 may be bent by receiving a force from the guide wire tube 40 that is difficult to extend and contract. However, since the first tube 41 and the second tube 42 of the present embodiment are relatively movable in the axial direction, the shaft outer tube 21 is unlikely to be bent by twisting. For this reason, the shaft part 20 can rotate smoothly. Moreover, the crushing part 60 does not shake more than necessary, and the machinability of the thrombus 300 can be maintained well.

Next, the pusher of the syringe 100 (see FIG. 1) is pulled to bring the hollow inside of the shaft inner tube 30 into a negative pressure state. Since the distal end portion of the inner shaft tube 30 communicates with the hollow interior of the outer shaft tube 21 and the outer shaft tube 21 communicates with the outside of the shaft portion 20 through the opening portion 22, the opening portion 22 is connected to the shaft portion. A suction force is generated to the outside of the 20. For this reason, the opening 22 draws the crushed thrombus 301 floating in the blood vessel. As shown in FIG. 11, a part of the thrombus 301 attracted to the opening 22 enters the hollow interior of the shaft outer tube 21.

After pulling the pusher of the syringe 100, the shaft inner tube 30 is moved in the axial direction with respect to the shaft outer tube 21. When the shaft inner tube 30 is moved from the state proximal to the opening 22 toward the distal side of the shaft outer tube 21, that is, the side closer to the contact portion 23, FIG. As shown, a part of the thrombus 301 that has entered the hollow interior of the outer shaft tube 21 through the opening 22 is cut off while being compressed by the distal surface of the inner tube 30.

When the inner tube 30 is moved until the distal surface of the inner shaft tube 30 abuts against the abutting surface 23A of the abutting portion 23, as shown in FIG. Fits inside the hollow. At this time, the thrombus 302 is cut into two by the blade portion 31A of the cutting portion 31 provided at the distal portion of the shaft inner tube 30. When the shaft inner tube 30 contacts the contact surface 23A of the contact portion 23, the blade portion 31A also contacts the contact surface 23A, and the thrombus 302 cut off in the hollow inside of the shaft outer tube 21 The blade portion 31A is cut while being pressed against the blade 23. For this reason, the thrombus 302 that has been cut off can be reliably cut to a size smaller than the inner diameter of the shaft inner tube 30. Thereby, it is possible to suppress clogging of the cut thrombus 302 in the hollow inside of the shaft inner tube 30.

Since the hollow interior of the tube 30 within the shaft is continuously in a negative pressure state by the syringe 100, as shown in FIG. 14, the cut thrombus 302 moves toward the proximal side of the hollow interior of the tube 30 within the shaft. Moving. Further, by moving the inner shaft tube 30 away from the contact portion 23 to the proximal side, the opening portion 22 is opened again, and the thrombus 301 is sucked and enters the hollow interior of the outer shaft tube 21. Therefore, the thrombus 301 can be continuously sucked while being finely cut by repeating the reciprocation of the inner tube 30 in the axial direction.

It is desirable that the rotating operation of the shaft outer tube 21 is continued while the crushed thrombus 301 is sucked by the shaft portion 20. Since the shaft outer tube 21 rotates, a vortex is generated in the blood in the blood vessel, and the thrombus 301 tends to gather near the center of rotation, that is, near the center in the radial direction of the blood vessel. It becomes easy to suck. Further, the vortex generated in the vicinity of the opening 22 also affects the flow inside the hollow of the shaft inner tube 30, and a vortex swirl is generated also inside the shaft inner tube 30. Thereby, the flow resistance with respect to the axial direction is reduced inside the inner tube 30 and the cut thrombus 302 can be sucked smoothly.

In this embodiment, during the suction of the thrombus 301, the shaft outer tube 21 rotates and the shaft inner tube 30 reciprocates in the axial direction with respect to the shaft outer tube 21, but other operations are performed. May be added. For example, when the inner tube 30 rotates differently relative to the outer shaft tube 21 (the rotation direction is the reverse direction, or the rotation direction is the same, but the rotation speed is different), suction is performed on the opening 22. The thrombus 301 formed can be more reliably cut out and guided to the hollow inside of the shaft outer tube 21. In addition, by adding the reciprocating motion of the shaft outer tube 21, a wider range of the thrombus 300 can be crushed and stirred.

<After the suction of the thrombus 301 is completed, the reciprocating and rotating motions of the shaft outer tube 21 and the shaft inner tube 30 are stopped. Next, the crushing part 60 is accommodated in the outer sheath 90, and the medical device 10 is extracted from the blood vessel. Thereafter, the filter device 110 is accommodated in a sheath or the like and removed from the blood vessel, and the treatment is completed.

As described above, the medical device 10 according to the embodiment includes a long shaft outer tube 21 (main tube) and a guide wire tube 40 (sub-unit) connected to the shaft outer tube 21 along with the shaft outer tube 21. The guide wire tube 40 includes a first tube 41 connected to the distal portion of the shaft outer tube 21, and the first tube 41 with respect to the shaft outer tube 21. And the second tube 42 connected at the proximal side, and the lumens of the first tube 41 and the second tube 42 are indirectly connected via the third tube 43 (other member). And the first tube 41 and the second tube 42 are relatively movable along the shaft outer tube 21. Note that the relative movement along the shaft outer tube 21 is not necessarily limited to the case of moving in parallel along the shaft outer tube 21.

The medical device 10 configured as described above is bent because the first tube 41 and the second tube 42 move relatively along the shaft outer tube 21 (main tube) when the medical device 10 is bent. Stiffness anisotropy is reduced. For this reason, even if the medical device 10 is inserted into a bent biological lumen, it is possible to suppress a decrease in performance. The names of “main tube” and “sub tube” do not limit the function of each tube. Therefore, the function of the secondary tube is not limited to the incidental function with respect to the function of the main tube.

Also, when the shaft outer tube 21 (main tube) is curved, the length from the proximal end portion of the first tube 41 to the distal end portion of the second tube 42 changes. Thereby, the curve of the shaft outer tube 21 is not hindered by the guide wire tubular body 40 (sub tube). Therefore, even if the medical device 10 is inserted into a bent biological lumen, it can suppress a decrease in performance.

The medical device 10 has a first end portion slidably in contact with the outer peripheral surface of the first tube 41, and a second end portion slidably in contact with the outer peripheral surface of the second tube 42. The third tube 43 is provided. As a result, the first tube 41 and the second tube 42 that are located apart can be connected smoothly with the third tube 43 communicating with the lumen. For this reason, an integral lumen (guide wire lumen 44) is maintained inside the guide wire tube 40, and the function of the guide wire tube 40 (function of guiding the guide wire) is not impaired.

The third tube 43 is connected to the shaft outer tube 21 (main tube). Thereby, even if the medical device 10 is bent, since the third tube 43 is not separated from the shaft outer tube 21, it is possible to suppress the third tube 43 from interfering with other members (for example, the crushing portion 60). . For this reason, even if the medical device 10 is inserted into a bent biological lumen, it is possible to suppress a decrease in performance. In addition, the third tube 43 is unlikely to fall off in the living body lumen, and safety can be improved.

Also, the shaft outer tube 21 (main tube) and the guide wire tube 40 (sub tube) can be integrally rotated in a connected state. When the shaft outer tube 21 and the guide wire tube 40 are rotated in a bent state, the direction of bending repeatedly changes with rotation. Even in such a case, the first tube 41 and the second tube 42 continue to move relatively with the rotation, and the anisotropy of the bending rigidity is reduced. For this reason, even if the medical device 10 rotates with the bent biological lumen, it can suppress a performance fall. Further, the shaft outer tube 21 and the guide wire tube 40 receive a torsional force by rotating, but the first tube 41 and the second tube 42 move relatively along the shaft outer tube 21. The bending of the outer shaft tube 21 and the guide wire tube 40 due to twisting can be suppressed. Therefore, the medical device 10 can suppress a decrease in performance even when the medical device 10 rotates and twists.

Further, the medical device 10 has a rotation center axis inside the shaft outer tube 21 (main tube). As a result, the guide wire tubular body 40 swings around the outer shaft tube 21 positioned at the center of rotation. A tube that swings around a curved tube needs to expand and contract in the axial direction during rotation. Therefore, the guide wire tube 40 having the relatively movable first tube 41 and the second tube 42 is a “swing tube”, so that smooth rotation around the shaft outer tube 21 is possible. It becomes possible.

The medical device 10 is connected to the distal portion of the outer shaft tube 21 (main tube) or the guide wire tube 40 (sub tube) and can be rotated, and can be deformed in a plurality of ways so as to have a plurality of gaps. It further has a crushing portion 60 that is formed into a cylindrical shape as a whole by the wire 61 and can be expanded in the radial direction of the shaft outer tube 21. Thereby, even if the medical device 10 is inserted into the bent biological lumen, the bending rigidity anisotropy is reduced, so that the appropriate position of the crushing portion 60 can be maintained, and the thrombus 300 in the biological lumen can be maintained. Appropriate and efficient crushing is possible. Further, when the clot 300 is crushed by the crushing portion 60, a torsional force acts on the shaft outer tube 21 and the guide wire tube 40, but the first tube 41 and the second tube 42 are applied to the shaft outer tube 21. Accordingly, the shaft outer tube 21 and the guide wire tube 40 can be prevented from being bent by twisting. Therefore, the medical device 10 can suppress the degradation of the crushing performance even when twisting occurs when crushing the thrombus 300 by the crushing unit 60.

Further, when the shaft outer tube 21 (main tube) and the guide wire tube 40 (sub tube) are curved, the third tube 43 (other member) of the first tube 41 and the second tube 42 is provided. The lengths L5 and L6 in the axial direction of the portion in contact with the outer peripheral surface are larger than the length when the shaft outer tube 21 and the guide wire tube 40 are linear during one rotation of the shaft outer tube 21. Has both long and short states. For this reason, the state where the shaft outer tube 21 and the guide wire tube 40 are curved can be well maintained even during rotation.

Note that the present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the living body lumen into which the medical device 10 is inserted is not limited to a blood vessel, and may be, for example, a blood vessel, a ureter, a bile duct, an oviduct, a hepatic duct, or the like.

Further, the present invention can be applied to any device that is used by being inserted into a living body lumen. Therefore, the medical device may not have a function of rotating, may not have a function of crushing an object, and may not have a function of sucking. Further, a plurality of main tubes may be provided, or a plurality of sub tubes may be provided.

In the medical device, the third tube 43 may not be connected to the shaft outer tube 21 as in the modification shown in FIG. 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 following expression (8) is satisfied so that the third tube 43 does not come out even if it moves to the distal side. Moreover, it is preferable that the following formula (9) is satisfied so that the third tube 43 does not come out even if it moves to the proximal side.

L3> L1 + Ld (8)
L3> L2 + Ld (9)

The third tube 43 is not connected to the shaft outer tube 21, so that the third tube 43 is easily separated from the shaft outer tube 21. For example, if the guide wire inserted into the third tube 43 is hard and the third tube 43 is connected to the shaft outer tube 21, the rigidity of the guide wire may affect the rotation. In such a case, as shown in FIG. 16, the influence of the guide wire on the rotation can be reduced by separating the third tube 43 from the shaft outer tube 21, which is effective. In addition, since the secondary tube 40 and the shaft outer tube 21 rotate with two separate axes when the secondary tube 40 is separated from the shaft outer tube 21, even if a thrombus enters the crushing portion 60, the secondary tube 40 and the shaft outer tube 21 rotate. The thrombus can be satisfactorily crushed by the tube 40 and the shaft outer tube 21.

In addition, as in another modification shown in FIG. 17, the third tube 48 is not disposed on the outer peripheral surface side of the first tube 41 and the second tube 42, but the first tube 41 and It may be arranged on the inner peripheral surface side of the second tube 42.

18, the third tube 51 may be disposed on the outer peripheral surface side of the first tube 41 and on the inner peripheral surface side of the second tube 50. . Further, the third tube may be arranged on the inner peripheral surface side of the first tube and on the outer peripheral surface side of the second tube.

Further, as in still another modification shown in FIG. 19, the third tube may not be provided. In the second tube 49, the proximal portion of the first tube 41 enters the lumen from the opening on the distal side. Accordingly, the distal end of the second tube 49 is located on the distal side of the proximal end of the first tube 41. The inner peripheral surface of the second tube 49 is slidable with the outer peripheral surface of the first tube 41. Thereby, since another member (3rd tube) becomes unnecessary between the 1st tube 41 and the 2nd tube 49, a number of parts can be reduced. By reducing the number of parts, the possibility of parts falling off during use can be reduced and safety can be improved, and the simple structure makes it difficult to break down and the cost can be reduced.

20 may be a structure in which the distal end portion of the second tube 42 enters from the opening on the proximal side of the first tube 52 as in another modification shown in FIG.

Further, in the above-described embodiment, the cutting unit 31 that sucks the thrombus 301 while cutting the thrombus 301 is provided inside the shaft unit 20, but the cutting unit 31 that cuts the thrombus 301 is not provided inside the shaft unit. May be. The shaft portion may not have a function of sucking the thrombus 301. In this case, the crushed thrombus 301 can be sucked by the outer sheath 90 or other sheath that accommodates the shaft portion. In addition, a guide wire lumen can be arranged inside the shaft outer tube without providing the shaft inner tube. In this case, a separate guide wire tube having a guide wire lumen may not be provided on the outer peripheral surface of the distal portion of the shaft outer tube. Therefore, the convex part slidably fitted into the slit 58 of the slide part 50 may be a solid member extending in the axial direction of the shaft outer tube, instead of a hollow guide wire tube. The convex portion may be configured integrally with the shaft outer tube.

Furthermore, this application is based on Japanese Patent Application No. 2016-45556 filed on Mar. 9, 2016, the disclosures of which are referenced and incorporated as a whole.

10 medical devices,
20 shaft part,
21 Shaft outer tube (main tube),
40 Tube for guide wire (sub tube),
41, 52 first tube,
42, 49, 50 second tube,
43, 48, 51 Third tube (other member),
44 Guide wire lumen (lumen),
45 1st connection part,
46 2nd connection part,
47 3rd connection part,
60 crushing section,
300, 301, 302 Thrombus.

Claims

A medical device having a long main tube and a secondary tube connected to the main tube along with the main tube,
The secondary tube is
A first tube connected to a distal portion of the main tube;
A second tube connected to the main tube on a more proximal side than the first tube,
The lumens of the first tube and the second tube communicate directly or indirectly through other members, and the first tube and the second tube are relative to each other along the main tube. Medical device that is movable to.
The medical device according to claim 1, wherein the inner peripheral surface or the outer peripheral surface of the proximal portion of the first tube is slidably in contact with the outer peripheral surface or the inner peripheral surface of the distal portion of the second tube. device.
The other member is a third tube, and the third tube has a first end and a second end, and the first end is an inner peripheral surface of the first tube. The medical device according to claim 1, wherein the medical device is slidably in contact with an outer peripheral surface, and the second end portion is slidably in contact with an inner peripheral surface or an outer peripheral surface of the second tube.
The medical device according to claim 3, wherein the third tube is connected to the main tube.
The medical device according to any one of claims 1 to 4, wherein the main tube and the sub tube are integrally rotatable in a connected state.
The medical device according to claim 5, which has a rotation center axis inside the main tube.
The main tube or the sub tube is connected to the distal portion of the main tube or the sub tube and is rotatable together with the shaft portion. The main tube or the sub tube is configured as a whole by a plurality of deformable wires so as to have a plurality of gaps. The medical device according to any one of claims 1 to 6, further comprising a crushing portion expandable in a radial direction of the tube.
When the main tube and the sub tube are curved, the length in the axial direction of the portion of the first tube and the second tube in contact with the inner peripheral surface or the outer peripheral surface of the other tube is the main tube. The medical device according to any one of claims 1 to 7, wherein the medical device has both a longer state and a shorter state than the length in the case where the main tube and the sub tube are straight.