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WO2021235199A1 - Dispositif à ballonnet - Google Patents

Dispositif à ballonnet Download PDF

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Publication number
WO2021235199A1
WO2021235199A1 PCT/JP2021/016779 JP2021016779W WO2021235199A1 WO 2021235199 A1 WO2021235199 A1 WO 2021235199A1 JP 2021016779 W JP2021016779 W JP 2021016779W WO 2021235199 A1 WO2021235199 A1 WO 2021235199A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
linear portion
shaft
linear
state
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2021/016779
Other languages
English (en)
Japanese (ja)
Inventor
修平 山本
伸二 稲垣
知陽 竹村
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Goodman Co Ltd
Original Assignee
Goodman Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Goodman Co Ltd filed Critical Goodman Co Ltd
Publication of WO2021235199A1 publication Critical patent/WO2021235199A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present disclosure relates to a balloon device used for a balloon catheter.
  • balloon catheters have been used in treatments such as PTA (percutaneous angioplasty) and PTCA (percutaneous coronary angioplasty).
  • the balloon catheter is provided with a balloon that can be expanded and contracted on its distal end side.
  • a balloon catheter a balloon is introduced in a contracted state into a portion narrowed or occluded by a lesion or the like generated in a blood vessel, and then the balloon is inflated to expand the portion.
  • Patent Document 1 proposes a device for a balloon, which is attached to a balloon catheter to improve the expanding force of the balloon in such a case.
  • the device of Patent Document 1 includes a long body that can be inserted into a guide wire lumen of a balloon catheter, and a wire rod having one end fixed to the distal portion of the long body and the other end extending to the proximal side. It is configured to have. This device is attached by inserting a long body from the distal side of the guide wire lumen and placing a wire rod on the outer peripheral surface of the balloon in the inserted state.
  • the device of Patent Document 1 is introduced into the body together with the balloon catheter in a state of being attached to the balloon catheter as described above. Then, the lesion is expanded by inflating the balloon with the device attached. In this case, when the balloon is inflated, a cut (crack) can be made in the lesion portion by the wire rod arranged on the outer peripheral surface of the balloon. Therefore, even if the lesion is hard, it is possible to easily expand the lesion by using the notch as a trigger.
  • the wire rod is arranged on the outer peripheral side of the balloon in a state of being attached to the balloon catheter. Then, in such an attached state, it is introduced into the body together with the balloon catheter. In this case, there is a concern that the wire rod may damage the tube wall in the body when the device is introduced into the body. Therefore, the device of Patent Document 1 still has room for improvement in that respect.
  • the present disclosure has been made in view of the above circumstances, and the main purpose of the present disclosure is to provide a balloon device capable of suppressing damage to the tube wall when introduced into the body.
  • the device for a balloon according to the first disclosure is a balloon catheter including a balloon that can be expanded and contracted, and a tube in which the balloon is attached to the distal end side and extends through the inside of the balloon.
  • a shaft to be inserted into the tube one end fixed to the distal end side of the shaft, the other end extending proximal to the one end, and the balloon.
  • the linear portion is provided with a linear portion arranged on the outer peripheral side of the shaft, and the linear portion extends along the shaft so that the linear portion can be inserted into the tube together with the shaft. It is formed.
  • the linear portion extends along the shaft so that it can be inserted into the tube of the balloon catheter together with the shaft.
  • the entire device including the linear portion and the shaft can be introduced into the body (intravascular) through the tube.
  • a balloon catheter can be introduced into the body in advance, and the balloon device can be introduced into the body through the tube of the balloon catheter.
  • the balloon device is introduced into the tube from the base end of the tube, and then the shaft is pushed distally until the linear portion is drawn distally from the distal end opening of the tube. Then, by pulling the shaft back to the proximal side, the linear portion is arranged on the outer peripheral side of the balloon.
  • the device can be introduced into the body through the inside of the balloon catheter, so that it is possible to prevent the linear portion from damaging the tube wall in the body during introduction into the body. can do.
  • the lesion part or the like is treated by inflating the balloon in the arranged state. After the treatment, the shaft is pulled proximally to remove the balloon device from the body through the tube. As a result, it is possible to prevent the linear portion from damaging the tube wall in the body even when the tube wall is removed from the body.
  • the balloon device of the second disclosure is formed so that at least the proximal end thereof is separated from the shaft in the natural state, and the linear portion is described more than the natural state. By bending toward the shaft side, the insertable state is established.
  • the linear portion when the balloon device is introduced into the body, when the linear portion is led out from the tube to the distal side, the linear portion naturally becomes a natural state and the proximal end portion of the linear portion is a shaft. Be separated from. Therefore, when the shaft is subsequently pulled back to the proximal side and the linear portion is arranged on the outer peripheral side of the balloon, it is possible to prevent the proximal end portion of the linear portion from being caught by the distal end of the tube. This makes it easier to arrange the linear portion on the outer peripheral side of the balloon.
  • the balloon device of the third disclosure includes, in the second disclosure, a closing means for bringing the linear portion closer to the shaft.
  • the shaft is first pushed to the distal side so that the linear portion arranged on the outer peripheral side of the balloon is located distal to the distal end of the tube. Then, by pulling the shaft back to the proximal side, the linear portion is introduced into the tube from the proximal end, and then by further pulling the shaft toward the proximal side, the balloon device is removed from the body.
  • at least the proximal end of the linear portion is separated from the shaft in the natural state of the linear portion. Therefore, when the linear portion is positioned distal to the tube from the outer peripheral side of the balloon during removal, it is conceivable that a part of the linear portion is separated from the shaft. In this case, when the linear portion is introduced into the tube, it is assumed that the introduction cannot be performed well, and it may be difficult to remove the balloon device.
  • a closing means for bringing the linear portion closer to the shaft is provided.
  • the linear portion can be easily introduced into the tube by bringing the linear portion closer to the shaft by a closing means. ..
  • the balloon device can be suitably removed while obtaining the effect of the second disclosure.
  • the balloon device of the fourth disclosure includes a plurality of suction members provided on the linear portion and the shaft, respectively, as the closing means, and suck each other by a suction force, and each suction thereof.
  • the member generates the suction force by applying a generation factor that generates the suction force from the outside.
  • suction members are provided on the linear portion and the shaft, respectively, and the linear portion can be brought closer to the shaft by the suction force of each of the suction members.
  • each suction member is adapted to generate a suction force by applying a generation factor that generates a suction force from the outside.
  • the linear portion is positioned from the outer peripheral side of the balloon to the distal side of the tube, and then the suction force of the suction member is generated, so that the linear portion is shafted by the suction force. Can be approached to. Thereby, when the linear portion is pulled into the tube and introduced, the introduction can be facilitated.
  • the balloon device of the fifth disclosure includes, as the closing means, a wire rod fixed to the linear portion and extending toward the proximal side of the fixing portion, and the wire rod is provided. By being pulled to the proximal side, the linear portion is brought closer to the shaft.
  • a wire rod is fixed to the linear portion, and the wire rod extends toward the proximal side of the fixed portion.
  • the linear portion is brought closer to the shaft.
  • the linear portion can be easily introduced into the tube by bringing the linear portion closer to the shaft when the balloon device is removed. Further, in this case, by pulling the wire rod to the proximal side, the entire linear portion can be brought closer to the shaft, so that the linear portion can be more easily introduced into the tube.
  • the balloon device of the sixth disclosure has the linear portion extending distally from the one end and the other end extending proximally from the distal end. It has a bent portion bent in such a manner, the distal end is formed by the top of the bent portion, and the linear portion is bendable at the top, and the bending thereof causes the other. By arranging the end side along the shaft, the insertable state is established.
  • the linear portion extends distally from one end fixed to the shaft and is bent by the bent portion so that the other end side extends proximally to the distal end. ing.
  • the linear portion when the shaft is pulled proximally from the state where the linear portion is arranged on the outer peripheral side of the balloon, the linear portion is introduced into the tube from the one end portion fixed to the shaft. Specifically, at this time, the other end side of the linear portion is inverted so that the other end portion faces the distal side, and the inverted portion is introduced into the tube.
  • the balloon device when the balloon device is removed through the tube, it can be removed with the linear portion introduced. Therefore, when the balloon device is removed, it is only necessary to pull it back to the proximal side, and the removal work can be facilitated.
  • the linear portion can be bent at the top of the bent portion (that is, the distal end of the linear portion), and the other end side of the distal end is arranged along the shaft by the bending. It is in a state where it can be inserted. Therefore, even if the linear portion has a bent portion, the insertability of the balloon device in the tube can be suitably ensured.
  • the balloon device of the seventh disclosure has the linear portion, one end of which is fixed to the distal end surface of the shaft.
  • the linear portion since one end of the linear portion is fixed to the distal end surface of the shaft, the linear portion is bent at the top of the bent portion so that it can be inserted into the linear portion.
  • One end side of the apex is located distal to the distal end of the shaft.
  • the height of protrusion of the linear portion from the outer peripheral surface of the shaft can be suppressed as compared with the case where one end side of the linear portion is arranged on the outer peripheral surface side of the shaft. Therefore, the structure in which the linear portion has a bent portion makes it possible to suitably improve the insertability of the balloon device in the tube.
  • the balloon device of the eighth disclosure is such that the linear portion is in the insertable state in a natural state, and the balloon is bent toward a side away from the shaft from the natural state. It will be placed on the outer peripheral side of.
  • the linear portion in the natural state of the linear portion, the linear portion extends along the shaft and is in an insertable state.
  • the shaft is pushed to the distal side to position the linear portion distal to the tube from the outer peripheral side of the balloon, so that the linear portion is naturally in a state where it can be inserted. Therefore, when the shaft is subsequently pulled back to the proximal side to introduce the linear portion into the tube, the introduction can be facilitated.
  • the balloon device of the ninth disclosure includes, in the eighth disclosure, an opening means for separating the proximal end of the linear portion from the shaft.
  • the linear portion when the balloon device is introduced into the body, when the linear portion is led out to the distal side of the tube of the balloon catheter, the linear portion remains in an insertable state.
  • the proximal end of the linear part since the proximal end of the linear part is close to the shaft, it is assumed that it will be difficult to arrange the linear part on the outer peripheral side of the balloon by pulling the shaft toward the proximal side. Will be done.
  • the proximal end of the linear portion can be separated from the shaft by the closing means, the shaft is pulled toward the proximal side in the separated state to pull the linear portion of the balloon. It can be arranged on the outer peripheral side. Therefore, even if the proximal end of the linear portion is close to the shaft, the linear portion can be suitably arranged on the outer peripheral side of the balloon.
  • the balloon device of the tenth disclosure includes a plurality of repulsive members provided on the linear portion and the shaft, respectively, as the opening means, and repel each other by a repulsive force, and each of the repulsive devices is provided.
  • the member generates the repulsive force by applying a generating factor that generates the repulsive force from the outside.
  • a repulsive member is provided on each of the linear portion and the shaft, and the proximal end portion of the linear portion is separated from the shaft by the repulsive force of each of the repulsive members.
  • each repulsive member is adapted to generate a repulsive force by applying a generating factor that generates a repulsive force from the outside.
  • the repulsive force of the repulsive member is generated, and the linear portion is generated by the repulsive force.
  • the proximal end of the can be separated from the shaft. This makes it possible to facilitate the work of pulling the shaft to the proximal side and arranging the linear portion on the outer peripheral side of the balloon.
  • the linear portion is a linear portion for forming a notch used for making a notch in a lesion portion in the body.
  • the linear portion is a linear portion for forming a notch for making a notch in a lesion portion in the body
  • the balloon is inflated with the linear portion arranged on the outer peripheral side of the balloon. This makes it possible to make a notch in the lesion by the linear part. Therefore, even if the lesion is hard, it is possible to easily expand the lesion by using the notch as a trigger.
  • the balloon device when arranging the linear portion for forming a notch on the outer peripheral side of the balloon, the balloon device can be introduced and arranged through the inside of the balloon catheter as described above. Therefore, when the lesion cannot be sufficiently expanded by the expanding force of the balloon, the linear portion can be arranged on the outer peripheral side of the balloon while the balloon catheter is arranged in the body. In this case, since the linear portion can be arranged on the balloon without moving the balloon catheter in and out of the body, the work can be easily performed when improving the expanding force of the balloon by the linear portion.
  • the balloon device of the twelfth disclosure includes, in any one of the first to eleventh disclosures, a detachable portion that detachably fixes the one end portion of the linear portion to the shaft.
  • the linear portion since the linear portion is removable from the shaft, the linear portion can be placed on the outer peripheral side of the balloon, and then the linear portion can be removed from the shaft and placed in the body. .. Therefore, if an indwelling device such as a stent that is indwelled in the body including the detachable linear portion is configured, the device can be introduced into the body through the inside of the balloon catheter. This makes it possible to prevent the tube wall from being damaged when the indwelling device is introduced into the body.
  • FIG. 1 A vertical sectional view showing the configuration of a balloon catheter.
  • A) is a side view showing the distal end side of the balloon device in the natural state of the linear portion
  • (b) is a side view showing the distal end side of the balloon device in the insertable state of the linear portion.
  • C) is a cross-sectional view taken along the line AA of (a)
  • (d) is an enlarged view showing the inside of the frame B of (c).
  • An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion.
  • the balloon device in the second embodiment is shown, (a) is a side view showing the distal end side of the balloon device in the natural state of the linear portion, and (b) is the insertion of the linear portion. It is a side view which shows the distal end side of the device for a balloon in a state, and (c) is a sectional view taken along the line CC of (a).
  • An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion. It is a side view which shows the distal end side of the balloon device in 3rd Embodiment, (a) shows the natural state of a linear part, and (b) is the state which the linear part is separated from a shaft. Shows. An explanatory diagram for explaining a series of steps of expanding a lesion using a balloon catheter and a balloon device and removing the balloon device from the body after expansion.
  • FIG. 3 is a cross-sectional view showing a cross section of a linear portion in another embodiment.
  • FIG. 1 It is a side view which shows the distal end side of the device for a balloon, (a) shows the natural state of a linear part, and (b) shows the insertable state of a linear part.
  • FIG. 1 is a schematic overall side view showing the configurations of the balloon device 10 and the balloon catheter 20.
  • FIG. 2 is a vertical cross-sectional view showing the configuration of the balloon catheter 20.
  • the balloon catheter 20 includes a catheter body 21, a hub 22 attached to a proximal end (base end) of the catheter body 21, and a distal end side of the catheter body 21 (as shown in FIG. It is provided with a balloon 23 attached to the tip side).
  • the catheter body 21 includes an outer tube 25 and an inner tube 26 inserted inside the outer tube 25, and has a double tube structure formed by both tubes 25 and 26.
  • the outer tube 25 is formed in a tubular shape made of a resin material, and has a lumen 25a extending in the entire axial direction inside the outer tube 25.
  • the proximal end of the outer tube 25 is connected to the hub 22, and the distal end of the outer tube 25 is joined to the proximal end of the balloon 23.
  • the lumen 25a of the outer tube 25 leads to the inner space of the balloon 23.
  • the lumen 25a of the outer tube 25 is a fluid lumen through which the compressed fluid flows when the balloon 23 is expanded or contracted.
  • the inner tube 26 is formed in a tubular shape made of a resin material, and has a lumen 26a extending in the entire axial direction inside the inner tube 26.
  • the proximal end of the inner tube 26 is connected to the hub 22.
  • the inner tube 26 extends toward the tip end side of the outer tube 25, and the extending portion is covered from the outside by the balloon 23. That is, the inner tube 26 extends through the inside of the balloon 23, and its distal end side is joined to the distal end of the balloon 23.
  • the inner tube 26 corresponds to a "tube".
  • the lumen 26a of the inner tube 26 is a lumen for the guide wire through which the guide wire G is inserted.
  • the lumen 26a of the inner tube 26 extends proximally from the distal end of the balloon catheter 20 to the hub 22.
  • the proximal end opening of the lumen 26a is formed at the proximal end of the catheter body 21. Therefore, the balloon catheter 20 is a so-called over-the-wire type catheter.
  • the balloon 23 is formed of a thermoplastic polyamide elastomer. However, the balloon 23 may be formed of another thermoplastic resin such as polyethylene or polypropylene.
  • the balloon 23 has its proximal end joined to the outer tube 25 and its distal end joined to the inner tube 26.
  • the balloon 23 has an inflatable portion that can be expanded and contracted between both ends joined to the tubes 25 and 26.
  • the balloon 23 (specifically, the inflated portion) is in an inflated state.
  • a negative pressure is applied to the lumen 25a of the outer tube 25 and the compressed fluid is discharged from the inside of the balloon 23, the balloon 23 is in a contracted state.
  • the hub 22 is formed in a Y shape by a resin material, and has a first pipe portion 28 and a second pipe portion 29 branched from the first pipe portion 28.
  • the first pipe portion 28 has a pipe hole 28a extending over the entire axial direction, and the pipe hole 28a communicates with the pipe hole 29a of the second pipe portion 29 at an intermediate position thereof.
  • the outer tube 25 and the inner tube 26 are inserted into the tube hole 28a of the first tube portion 28 from the tip end side thereof. Each of these tubes 25 and 26 is joined to the first tube portion 28 in the inserted state.
  • the lumen 25a of the outer tube 25 communicates with the tube hole 29a of the second tube portion 29 via the tube hole 28a of the first tube portion 28.
  • a fluid supply device such as a pressurizer
  • FIG. 3 is a sectional view taken along line AA of FIG. 3A
  • FIG. 3D is an enlarged view showing the inside of the frame B of FIG. 3C in an enlarged manner.
  • the balloon device 10 includes a shaft 11 and a linear portion 12 fixed to the distal end of the shaft 11.
  • the shaft 11 is formed in a tubular shape by a resin material, and more specifically, in a circular tubular shape.
  • the shaft 11 has a pipe hole 11a extending over the entire axial direction.
  • the tube hole 11a is used as a lumen for the guide wire through which the guide wire G is inserted.
  • the shaft 11 does not necessarily have to be formed of a resin material, and may be formed of another material such as a metal material.
  • the shaft 11 is inserted into the inner tube 26 (specifically, the lumen 26a thereof) of the balloon catheter 20, and its outer diameter is smaller than the inner diameter of the inner tube 26. Further, the shaft 11 has a length dimension sufficiently longer than the length of the inner tube 26. Therefore, when the shaft 11 is inserted into the inner tube 26, a part of the shaft 11 is brought out to the proximal end side of the inner tube 26 and further to the proximal end side of the hub 22.
  • the linear portion 12 is arranged on the outer peripheral side of the balloon 23 of the balloon catheter 20, and is used to make a notch in the lesion portion when the balloon 23 is inflated to expand the lesion portion.
  • a plurality of linear portions 12 are arranged at predetermined intervals (specifically, at equal intervals) in the circumferential direction of the shaft 11. In the present embodiment, three linear portions 12 are arranged, and all of these linear portions 12 have the same configuration.
  • the linear portion 12 corresponds to the “linear portion for forming a notch”.
  • the linear portion 12 is linearly formed of a flexible metal material and is formed of, for example, a superelastic alloy such as nickel titanium (Ni—Ti).
  • the linear portion 12 is formed to be thinner than the shaft 11, and its length is longer than the axial length of the balloon 23.
  • the linear portion 12 may be formed of a metal material other than the superelastic alloy, or may be formed of a material other than the metal material such as a hard resin. That is, as long as the linear portion 12 is a flexible material, the material may be arbitrary.
  • One end portion 13 of the linear portion 12 is fixed to the distal end surface (tip surface) of the shaft 11 by adhesion or the like.
  • one end portion 13 of the linear portion 12 is a fixed end portion with respect to the shaft 11, and is hereinafter referred to as a fixed end portion 13.
  • the other end side of the linear portion 12 extends proximally to the fixed end portion 13, and the other end portion 14 is a free end.
  • the other end 14 of the linear portion 12 constitutes a proximal end portion of the linear portion 12, and is hereinafter referred to as a proximal end portion 14.
  • the linear portion 12 has a bent portion 15 on the fixed end portion 13 side thereof.
  • the bent portion 15 is formed to be bent so as to be convex toward the distal side, and more specifically, the bent portion 15 is formed to be curved.
  • the linear portion 12 extends from the fixed end portion 13 toward the distal side, and is bent by the bending portion 15 so that the proximal end portion 14 side of the distal end extends toward the proximal side. ..
  • the bent portion 15 may be bent instead of curved.
  • the top portion 15a constituting the distal end portion constitutes the distal end of the linear portion 12.
  • the fixed end portion 13 side from the top portion 15a is referred to as the first portion 12a
  • the proximal end portion 14 side from the top portion 15a is referred to as the second portion 12b.
  • the bent portion 15 is bent so that the first portion 12a and the second portion 12b are aligned in the radial direction of the shaft 11. Therefore, when the linear portion 12 is viewed from one side in the axial direction of the shaft 11, the linear portion 12 extends outward along the radial direction from the shaft 11.
  • the second portion 12b of the linear portion 12 extends proximally from the top portion 15a of the bent portion 15 and has a curved shape that is gently convex toward the radial outer side of the shaft 11 as a whole.
  • the second portion 12b is arranged radially outside the shaft 11 so as to be separated from the shaft 11. Therefore, the proximal end 14 of the second portion 12b is also separated from the shaft 11. In this case, the separation distance between the proximal end portion 14 and the shaft 11 is made larger than the thickness of the inner tube 26. Further, the distance between the proximal end portion 14 and the central axis of the shaft 11 is made larger than the radius of the inner tube 26.
  • the linear portion 12 has a triangular cross section (specifically, a cross section orthogonal to the length direction of the linear portion 12). Therefore, the linear portion 12 has three surfaces 18a to 18c extending in the length direction. Of these surfaces 18a to 18c, the surface 18a facing the shaft 11 side is an arrangement surface 18a arranged on the outer peripheral surface of the balloon 23. In FIG. 3C, the outer peripheral surface of the balloon 23 is shown by a two-dot chain line for reference.
  • the top portion 17 formed by the surfaces 18b and 18c other than the arrangement surface 18a protrudes outward in the radial direction of the shaft 11.
  • the apex 17 is used to make a notch in the lesion when treating the lesion.
  • the angle ⁇ formed by the top portion 17 is an obtuse angle, for example, 100 ° to 120 °.
  • the cross section of the linear portion 12 has an isosceles triangle shape in which the widths of the surfaces 18b and 18c forming the obtuse-angled top portion 17 are equal.
  • the width L1 of the arrangement surface 18a is larger than the length L2 (in other words, the distance between the arrangement surface 18a and the top 17) in the direction orthogonal to the arrangement surface 18a (in other words, the distance between the arrangement surface 18a and the top 17).
  • the linear portion 12 can be in a state of extending along the shaft 11 by bending toward the shaft 11 from the natural state (state of FIG. 3 (a)). It has become.
  • each linear portion 12 is in this state, so that each linear portion 12 can be inserted into the inner tube 26 of the balloon catheter 20 together with the shaft 11.
  • the state in which the linear portion 12 can be inserted into the inner tube 26 is referred to as an insertable state.
  • the natural state of the linear portion 12 means a state of the linear portion 12 when no external force is applied to the linear portion 12.
  • the linear portion 12 In the insertable state of the linear portion 12, the linear portion 12 is folded back at the top portion 15a of the bent portion 15, and the folded portion causes the first portion 12a and the second portion 12b to overlap each other in the radial direction of the shaft 11. It is said to be in a state of being. In this case, the first portion 12a and the second portion 12b are in a state of extending along the axial direction of the shaft 11, and the arrangement surface 18a of the second portion 12b is in contact with the outer peripheral surface of the shaft 11. Further, in the insertable state of each linear portion 12, when a virtual circle circumscribing each of the linear portions 12 is assumed, the diameter of the virtual circle is smaller than the inner diameter of the inner tube 26.
  • a guiding catheter is inserted into the sheath introdisa inserted into the blood vessel, and the guiding catheter is introduced to just before the lesion 38 generated in the body.
  • the guide wire G is inserted into the guiding catheter, and the inserted guide wire G is introduced to a position beyond the lesion 38.
  • the guide wire G is inserted into the inner tube 26 of the balloon catheter 20, and the balloon catheter 20 is introduced into the guiding catheter along the inserted guide wire G.
  • the balloon 23 is placed on the lesion 38 while performing a push-pull operation. When introducing the balloon catheter 20, the balloon 23 is kept in a contracted state.
  • the lesion portion 38 is expanded by inflating the balloon 23.
  • the lesion portion 38 is calcified and hardened, which makes it difficult to sufficiently expand the lesion portion 38. Therefore, in the following, the balloon device 10 will be used to improve the expansion force of the balloon 23, and the work procedure in that case will be described below.
  • the balloon 23 is brought into a contracted state.
  • a predetermined gap 39 is formed between the outer peripheral surface of the balloon 23 and the lesion 38.
  • each linear portion 12 of the balloon device 10 is placed in an insertable state (state of FIG. 3B), and the balloon device 10 is introduced into the inner tube 26 of the balloon catheter 20 from the proximal end side in that state.
  • the balloon device 10 is introduced into the inner tube 26 via the tube hole 28a of the hub 22.
  • the guide wire G is inserted into the tube hole 11a of the shaft 11, and the balloon device 10 is introduced into the inner tube 26 in the inserted state.
  • each linear portion 12 of the balloon device 10 is led out to the distal side of the inner tube 26.
  • each linear portion 12 naturally changes from the insertable state to the natural state (state of FIG. 3A). Therefore, in this case, the proximal end portion 14 of each linear portion 12 is in a state of being separated from the shaft 11.
  • each linear portion 12 is arranged on the outer peripheral side of the balloon 23 through the gap 39 between the balloon 23 and the lesion portion 38.
  • each linear portion 12 is attached to the outer peripheral surface of the balloon 23.
  • the proximal end portion 14 of the linear portion 12 is separated from the shaft 11, the proximal end of each linear portion 12 is arranged.
  • the portion 14 can be prevented from being caught on the distal end of the inner tube 26. Therefore, it is possible to facilitate the work of arranging each linear portion 12 on the outer peripheral side of the balloon 23.
  • the lesion 38 is expanded by inflating the balloon 23.
  • the expansion of the balloon 23 presses each linear portion 12 against the lesion 38, whereby the linear portions 12 make a cut (crack) in the lesion 38. Therefore, the lesion 38 can be suitably expanded by using the notch as a trigger.
  • each linear portion 12 is displaced toward the shaft 11 and returns to the natural state.
  • each linear portion 12 is introduced into the inner tube 26 by pulling the shaft 11 back to the proximal side.
  • each linear portion 12 is introduced into the inner tube 26 from its fixed end portion 13.
  • each linear portion 12 is introduced into the inner tube 26 in an inverted state in which the second portion 12b is inverted so that the proximal end portion 14 faces the distal side.
  • the shaft 11 is pulled proximally in the introduced state, and the balloon device 10 is removed from the body.
  • each line is simply pulled back to the proximal side from the state where each linear portion 12 is arranged on the outer peripheral side of the balloon 23 (see FIG. 5 (g)).
  • the shaped portion 12 can be introduced into the inner tube 26, and the device 10 can be removed in the introduced state. Therefore, it is possible to facilitate the work of removing the balloon device 10.
  • the balloon catheter 20 is removed from the body. This completes a series of work.
  • Each linear portion 12 of the balloon device 10 is formed so as to extend along the shaft 11 so that it can be inserted into the inner tube 26 of the balloon catheter 20 together with the shaft 11.
  • the balloon device 10 can be introduced into the body through the inner tube 26 of the balloon catheter 20 previously introduced into the body. Then, at the time of introduction, each linear portion 12 can be arranged on the outer peripheral side of the balloon 23 by pushing and pulling the shaft 11. As a result, when the balloon device 10 is introduced into the body, it is possible to prevent the linear portion 12 from damaging the tube wall in the body.
  • the linear portion 12 is arranged on the outer peripheral side of the balloon 23 while leaving the balloon 23 (balloon catheter 20) in the body. be able to.
  • the linear portion 12 can be arranged on the balloon 23 without moving the balloon 23 in and out of the body, the work can be easily performed when improving the expanding force of the balloon 23 by the linear portion 12. Can be done.
  • the balloon 23 is taken in and out, it is necessary to align the balloon 23 with the lesion 38 again, and it may take a lot of time and effort to align the balloon 23. Therefore, the balloon is left in the body. It is significant that the linear portion 12 can be arranged on the 23.
  • the linear portion 12 can be bent at the top portion 15a of the bent portion 15, and the proximal end portion 14 side of the distal end is arranged along the shaft 11 by the bending, so that the linear portion 12 can be inserted. .. Thereby, even if the linear portion 12 has the bent portion 15, the insertability of the balloon device 10 in the inner tube 26 can be suitably ensured.
  • the fixed end portion 13 of the linear portion 12 is fixed to the distal end surface of the shaft 11, when the linear portion 12 is bent at the top portion 15a of the bent portion 15 to be in an insertable state.
  • the fixed end 13 side of the linear portion 12 with respect to the apex 15a is arranged distal to the distal end of the shaft 11.
  • the protrusion height of the linear portion 12 from the outer peripheral surface of the shaft 11 can be suppressed as compared with the case where the fixed end portion 13 side of the linear portion 12 is arranged on the outer peripheral surface side of the shaft 11 with respect to the top portion 15a. can. Therefore, the linear portion 12 has a bent portion 15, and the insertability of the balloon device 10 in the inner tube 26 can be suitably improved.
  • the linear portion 12 Can be arranged in a stable state when the balloon 23 is arranged on the outer peripheral surface of the balloon 23.
  • FIG. 6 (a) and (b) are side views showing the distal end side of the balloon device 30 in the present embodiment, and (a) shows the natural state of the linear portion 32. b) indicates a state in which the linear portion 32 can be inserted. Further, in FIG. 6, (c) is a sectional view taken along line CC of (a).
  • the balloon device 30 of the present embodiment includes a shaft 31 and a plurality of (specifically, three) linear portions 32. Since the shaft 31 has the same configuration as the shaft 11 in the first embodiment, the description thereof is omitted here. On the other hand, the linear portion 32 has a different configuration from the linear portion 12 in the first embodiment.
  • One end 33 of the linear portion 32 is fixed to the distal end portion of the shaft 31. In this case, one end 33 of the linear portion 32 is a fixed end portion with respect to the shaft 31, and is hereinafter referred to as a fixed end portion 33.
  • the fixed end 33 of the linear portion 32 is fixed to the outer peripheral surface of the shaft 31. Specifically, the fixed end 33 of the linear portion 32 is fixed to the outer peripheral surface of the shaft 31 on the outer peripheral surface thereof.
  • the linear portion 32 extends from the fixed end portion 33 to the proximal side, and the proximal end portion 34 thereof is a free end.
  • the linear portion 32 has a curved shape that is gently convex toward the radial outer side of the shaft 31 as a whole, and a portion other than the fixed end portion 33 is separated from the shaft 31. Therefore, the proximal end 34 of the linear portion 32 is also separated from the shaft 31.
  • each linear portion 32 can be in a state of extending along the shaft 31 by bending toward the shaft 31 from the natural state (state of FIG. 6 (a)). It has become. Then, each linear portion 32 is in an insertable state so that it can be inserted into the inner tube 26 together with the shaft 31 in such a state. In the insertable state of each linear portion 32, each linear portion 32 is in a state of extending along the shaft 31 over the entire length direction. Further, in this case, each linear portion 32 is arranged in a state of being in contact with the outer peripheral surface of the shaft 31.
  • the shaft 31 and the linear portion 32 are provided with suction members 36 and 37 that suck each other by a magnetic force (corresponding to a suction force), respectively.
  • the attractive members 36 and 37 are made of a magnetic material, and are magnetized to generate a magnetic force when a magnetic field (corresponding to a generating factor) is applied from the outside.
  • the suction member 36 is provided on the shaft 31, and the suction member 37 is provided on each linear portion 32.
  • the suction member 36 is formed in a cylindrical shape and is attached to the outer peripheral surface of the shaft 31.
  • the suction member 36 is arranged (slightly) proximally to the proximal end 34 of the linear portion 32 in the axial direction of the shaft 31.
  • the suction member 37 is attached to the proximal end portion 34 of each linear portion 32, respectively.
  • Each suction member 37 is located (slightly) distal to the suction member 36 in the axial direction of the shaft 31.
  • each suction member 37 may be at the same position as the suction member 36 in the axial direction of the shaft 31.
  • each suction member 37 is arranged at the same position as the suction member 36 in the axial direction of the shaft 31, and more specifically, is arranged on the proximal side of the suction member 36 (FIG. 6 (FIG. 6). b) See). In this case, each suction member 37 is arranged so as to overlap the suction member 36.
  • FIGS. 7 and 8 are explanations for explaining a series of flow of the work of expanding the lesion portion using the balloon catheter 20 and the balloon device 30 and the work of removing the balloon device 30 from the body after the expansion. It is a figure.
  • each linear portion 32 of the balloon device 30 is made insertable, and the balloon device 30 is introduced into the inner tube 26 of the balloon catheter 20 in that state.
  • the shaft 31 is pushed to the distal side, and as shown in FIG. 7A, each linear portion 32 is led out to the distal side from the distal end opening of the inner tube 26.
  • each linear portion 32 changes from an insertable state to a natural state, and the proximal end portion 34 of each linear portion 32 is separated from the shaft 31.
  • each linear portion 32 is attached to the outer peripheral surface of the balloon 23. Further, in this arrangement, since the proximal end portion 34 of the linear portion 32 is separated from the shaft 31, it is easy to arrange each linear portion 32 on the outer peripheral side of the balloon 23.
  • each linear portion 32 is arranged on the balloon 23 in the state where each linear portion 32 is arranged on the balloon 23.
  • the suction member 37 provided on the proximal end 34 and the suction member 36 provided on the shaft 31 are also located slightly proximal to the proximal end of the balloon 23.
  • the suction member 36 is arranged inside the inner tube 26 (and thus inside the catheter body 21) together with the shaft 31, but in FIG. 7 (c), the suction member 36 is shown by a dot hatch for easy understanding (described later). The same applies to FIG. 7 (d).
  • a magnetic field is generated by a magnetic field generator (not shown) prepared in advance, and a magnetic field is applied to the suction members 36 and 37.
  • a magnetic force is generated from the suction members 36 and 37, and the magnetic force brings the proximal end portion 34 of each linear portion 32 closer to the shaft 31 side.
  • the shaft 31 (and the suction member 36) is arranged inside the catheter body 21, the proximal end portion 34 of the linear portion 32 is brought closer to the catheter body 21, and the catheter body 21 (and the catheter body 21 () Specifically, it is in a state of being fixed to the outer peripheral surface of the outer tube 25).
  • each linear portion 32 is fixed to the outer peripheral surface of the balloon 23.
  • each linear portion 32 makes a cut (crack) in the lesion portion 38, and the lesion portion 38 can be suitably expanded by using the cut as a trigger. Further, since each linear portion 32 is fixed to the balloon 23 when the balloon 23 is inflated, it is possible to prevent the linear portions 32 from being displaced on the balloon 23.
  • each linear portion 32 is positioned distal to the inner tube 26 from the outer peripheral side of the balloon 23. As a result, each linear portion 32 is in a natural state.
  • each linear portion 32 is introduced into the inner tube 26 by pulling back the shaft 31 toward the proximal side.
  • each linear portion 32 is introduced from the proximal end portion 34 into the inner tube 26. Then, in such an introduced state, the shaft 31 is pulled toward the proximal side to remove the balloon device 30.
  • each linear portion 32 is introduced into the inner tube 26, since the proximal end portion 34 of each linear portion 32 is brought close to the shaft 31, each linear portion 32 is inside from the proximal end portion 34. It is easy to introduce into the tube 26. Therefore, the balloon device 30 can be suitably removed.
  • each linear portion 32 When the linear portion 32 is brought closer to the shaft 31 by the magnetic force of each of the suction members 36 and 37, the linear portion 32 does not necessarily have to be in an insertable state, for example, the proximal end of the linear portion 32. Only the portion 34 may be brought close to the shaft 31. Even in that case, each linear portion 32 can be easily introduced into the inner tube 26. Further, in this case, after each linear portion 32 is introduced into the inner tube 26, it is pressed against the inner peripheral surface of the tube 26 so that it can be inserted.
  • the balloon device 30 can be introduced into the body through the inner tube 26 of the balloon catheter 20 as in the first embodiment. Therefore, when the balloon device 30 is introduced into the body, it is possible to prevent the linear portion 32 from damaging the tube wall in the body.
  • FIG. 9A and 9B are side views showing the distal end side of the balloon device 40 in the present embodiment, in which FIG. 9A shows the natural state of the linear portion 42, and FIG. 9B shows the linear portion 42. Indicates a state separated from the shaft 41.
  • the balloon device 40 of the present embodiment includes a shaft 41 and a plurality of (specifically, three) linear portions 42. Since the shaft 41 has the same configuration as the shaft 11 in the first embodiment, the description thereof is omitted here.
  • the linear portion 42 extends linearly along the shaft 41, and the distal end portion 43 which is one end thereof is fixed to the distal end portion of the shaft 41, and the proximal end portion 44 which is the other end portion is fixed. Is the free end.
  • the linear portion 42 is in contact with the outer peripheral surface of the shaft 41 over the entire length direction.
  • each linear portion 42 can be inserted into the inner tube 26 together with the shaft 41. Therefore, in the balloon device 40, when each linear portion 42 is in a natural state, each linear portion 42 can be inserted into the inner tube 26 together with the shaft 41.
  • the shaft 41 and the linear portion 42 are provided with repulsive members 46 and 47 that repel each other by a magnetic force (corresponding to a repulsive force), respectively.
  • the repulsive members 46 and 47 are made of a magnetic material, and when a magnetic field is applied from the outside, they are magnetized to generate a magnetic force (corresponding to a factor that generates a repulsive force).
  • the repulsive member 46 is provided on the shaft 41, and the repulsive member 47 is provided on each linear portion 42, respectively.
  • the repulsive member 46 is formed in a cylindrical shape and is attached to the outer peripheral surface of the shaft 41.
  • the repulsive member 46 is arranged at the same position as the proximal end portion 44 of the linear portion 42 in the axial direction of the shaft 41.
  • the repulsive member 47 is attached to the proximal end portion 44 of each linear portion 42, respectively.
  • Each repulsive member 47 is arranged at the same position as the repulsive member 46 in the axial direction of the shaft 41.
  • the repulsive members 46 and 47 When a magnetic field is applied to the repulsive members 46 and 47 from the outside, the repulsive members 46 and 47 are magnetized and a magnetic force is generated as described above. In this case, the repulsive members 46 and 47 are repelled from each other by the magnetic force, whereby the proximal end portion 44 of the linear portion 42 is separated from the shaft 41 as shown in FIG. 9B. Specifically, in this case, the linear portion 42 bends toward the side away from the shaft 41, and substantially the entire linear portion 42 is separated from the shaft 41. In this case, the opening means is composed of the repulsive members 46 and 47.
  • 10 and 11 are descriptions for explaining a series of flow of the work of expanding the lesion portion using the balloon catheter 20 and the balloon device 40 and the work of removing the balloon device 40 from the body after the expansion. It is a figure.
  • the balloon device 40 is introduced into the inner tube 26 of the balloon catheter 20.
  • the balloon device 40 since each linear portion 42 is in a state in which it can be inserted in a natural state, the balloon device 40 may be introduced into the inner tube 26 as it is, and it is easy to introduce the balloon device 40.
  • each linear portion 42 After the introduction, by pushing the shaft 41 toward the distal side, as shown in FIG. 10A, each linear portion 42 is led out to the distal side from the distal end opening of the inner tube 26. In this case, each linear portion 42 is led out from the inner tube 26 in an insertable state (natural state). Therefore, the proximal end 44 of each linear portion 42 is in contact with the shaft 41.
  • a magnetic field is generated by a magnetic field generator (not shown) prepared in advance, and a magnetic field is applied to the repulsive members 46 and 47.
  • a magnetic field is generated from the repulsive members 46 and 47, and the magnetic force causes the proximal end portion 44 of each linear portion 42 to be separated from the shaft 41.
  • each linear portion 42 is arranged on the outer peripheral side of the balloon 23 by pulling back the shaft 41 toward the proximal side.
  • each linear portion 42 is attached to the outer peripheral side of the balloon 23.
  • the proximal end portion 44 of the linear portion 42 is separated from the shaft 41, it is possible to easily arrange each linear portion 42 on the outer peripheral side of the balloon 23.
  • the generation of the magnetic field by the magnetic field generator is stopped.
  • the repulsive members 46 and 47 are in a state where no magnetic force is generated.
  • each linear portion 42 makes a cut (crack) in the lesion portion 38, and the lesion portion 38 can be suitably expanded by using the cut as a trigger.
  • each linear portion 42 is positioned from the outer peripheral side of the balloon 23 to the distal side of the inner tube 26.
  • each linear portion 42 is in a natural state, that is, in an insertable state.
  • each linear portion 42 is introduced into the inner tube 26 by pulling back the shaft 41 toward the proximal side.
  • each linear portion 42 since each linear portion 42 is in an insertable state, each linear portion 42 can be introduced into the inner tube 26 simply by pulling back the shaft 41 as it is. Therefore, the introduction can be facilitated.
  • the shaft 41 is pulled toward the proximal side in the introduced state, and the balloon device 40 is removed.
  • the balloon device 40 can be introduced into the body through the inner tube 26 of the balloon catheter 20 as in the first and second embodiments. Therefore, when the balloon device 40 is introduced into the body, it is possible to prevent the linear portion 42 from damaging the tube wall in the body.
  • FIG. 12 is a side view showing the distal end side of the balloon device 50 in the present embodiment, in which (a) shows the natural state of the linear portion 32 and (b) is the linear portion 32. Indicates the insertable state of.
  • the balloon device 50 of the present embodiment includes a shaft 31 and a plurality of linear portions 32.
  • the shaft 31 and each linear portion 32 have the same configuration as the shaft 31 and each linear portion 32 of the balloon device 30 in the second embodiment. Therefore, the same reference numerals as those of the shaft 31 and the linear portion 32 of the balloon device 30 are given here, and the description of each of the portions 31 and 32 is omitted. Further, in the following, the description of each part of the linear portion 32 will be omitted with the same reference numerals as those of the second embodiment.
  • a wire rod 51 as a closing means is attached to each of the proximal end portions 34 of each linear portion 32.
  • the wire rod 51 is formed to have flexibility and strength to withstand a certain amount of tensile force.
  • the wire rod 51 is made of, for example, a thread (suture), and more specifically, the material (material) thereof is a vegetable material or an animal material.
  • the length of the wire 51 is equal to or longer than the length of the shaft 31.
  • the wire rod 51 is arranged along the shaft 31, and its distal end (one end) is fixed to the proximal end 34 of the linear portion 32.
  • the material of the wire rod 51 may be another material such as a metal material or a resin material. Further, in FIGS. 12 (a) and 12 (b), for convenience, each wire rod 51 is shown by a broken line (dotted line) (the same applies to FIG. 13 described later).
  • each linear portion 32 is pulled to the proximal side accordingly, and as a result, the proximal end portion 34 of each linear portion 32 is a shaft. You can get closer to 31. Specifically, in this case, the entire linear portion 32 is brought close to the shaft 31, and each linear portion 32 is in a state of extending along the shaft 31. Therefore, in the present balloon device 50, each wire rod 51 is pulled to the proximal side so that each linear portion 32 can be inserted into the inner tube 26 together with the shaft 31.
  • FIG. 13 is an explanatory diagram for explaining a series of flow of the work of expanding the lesion portion using the balloon catheter 20 and the balloon device 50 and the work of removing the balloon device 50 from the body after the expansion. ..
  • each linear portion 32 of the balloon device 50 can be inserted, and in that state, the balloon device 50 is introduced into the inner tube 26 of the balloon catheter 20.
  • the shaft 31 is pushed to the distal side, and as shown in FIG. 13A, each linear portion 32 is led out to the distal side from the distal end opening of the inner tube 26.
  • each linear portion 32 is in a natural state (state in FIG. 12 (a)), and the proximal end portion 34 of each linear portion 32 is separated from the shaft 31.
  • each linear portion 32 is arranged on the outer peripheral side of the balloon 23 by pulling back the shaft 31 toward the proximal side.
  • each linear portion 32 can be easily arranged on the outer peripheral side of the balloon 23.
  • each linear portion 32 makes a cut (crack) in the lesion portion 38, and the lesion portion 38 can be suitably expanded by using the cut as a trigger.
  • each linear portion 32 is positioned distal to the inner tube 26 from the outer peripheral side of the balloon 23. After that, each wire rod 51 is pulled toward the proximal side so that each linear portion 32 can be inserted.
  • each linear portion 32 is introduced into the inner tube 26 by pulling the shaft 31 back to the proximal side.
  • the linear portions 32 are introduced into the inner tube 26 while the linear portions 32 are maintained in an insertable state by pulling the wire rods 51 to the proximal side.
  • the shaft 31 is pulled toward the proximal side to remove the balloon device 50.
  • each linear portion 32 is introduced into the inner tube 26 since the proximal end portion 34 of each linear portion 32 is brought close to the shaft 31, it is easy to introduce each linear portion 32 into the inner tube 26. It has become. Further, when the linear portions 32 are introduced into the inner tube 26, the linear portions 32 are in a state in which they can be inserted, so that the linear portions 32 can be more easily introduced into the inner tube 26.
  • the balloon device 50 can be introduced into the body through the inner tube 26 of the balloon catheter 20 as in the first to third embodiments. Therefore, when the balloon device 50 is introduced into the body, it is possible to prevent the linear portion 32 from damaging the tube wall in the body.
  • suction members 36 and 37 (magnetic materials) that suck each other by magnetic force (corresponding to suction force) are used as the suction member, but electrostatic force (suction force) is used as the suction member.
  • electrostatic force suction force
  • suction member that sucks each other by magnetic force (corresponding to suction force) or electromagnetic force (corresponding to suction force).
  • a current corresponding to a factor that generates suction force
  • the above suction members are subjected to the above. It is conceivable to generate the electrostatic force and the above-mentioned electromagnetic force. Even in such a configuration, since a suction force can be generated in each suction member as needed, the same effect as that of the second embodiment can be obtained.
  • the repulsive members 46 and 47 (magnetic materials) that repel each other by magnetic force (corresponding to the repulsive force) are used as the repulsive member, but the electrostatic force (repulsive force) is used as the repulsive member.
  • Repulsive members that repel each other by electromagnetic force (corresponding to repulsive force) may be used.
  • a current corresponding to a factor that generates the repulsive force
  • an external power source that is, by energizing each repulsive member via wiring or the like
  • the above-mentioned repulsive member is described above. It is conceivable to generate the electrostatic force of the above and the electromagnetic force of the above. Even in such a configuration, since a repulsive force can be generated in each repulsive member as needed, the same effect as that of the third embodiment can be obtained.
  • the balloon device is provided with three linear portions, but the number of linear portions may be four or more, or may be two. Further, there may be one. Further, in the above embodiment, the plurality of linear portions are arranged at equal intervals (uniformly) in the circumferential direction of the shaft, but the plurality of linear portions are arranged at irregular intervals (non-uniform) in the circumferential direction of the shaft. May be good.
  • the cross-sectional shape of the linear portion is not necessarily limited to that of the above embodiment.
  • the top 17 of the linear portion 12 has an obtuse angle, but as shown in FIG. 14A, the top 56 of the linear portion 55 may have an acute angle. In this case, it is possible to easily make a notch in the lesion portion.
  • the arrangement surface 58 arranged on the outer peripheral surface of the balloon 23 in the linear portion 57 may be a curved surface that matches (follows) the outer peripheral surface of the balloon 23.
  • the linear portion 57 can be arranged on the outer peripheral surface of the balloon 23 in a stable state.
  • the expanding force of the balloon 23 is suitably applied to the linear portion 57. I can tell. Therefore, an expanding force can be suitably applied to the lesion portion from the linear portion 57.
  • the cross-sectional shape of the linear portion does not necessarily have to be a triangular shape, and may be another shape such as a quadrangular shape or a semicircular shape.
  • the cross section of the linear portion 61 has a semicircular shape, and the linear portion 61 has a curved surface portion 62 (arc surface) that is convex outward in the radial direction of the shaft 11. doing. In this case, when the balloon device is introduced into the body, it is possible to further suppress the damage to the tube wall due to the linear portion 61.
  • a protrusion 66 may be provided on the linear portion 65.
  • a plurality of protrusions 66 are provided on each linear portion 65 at predetermined intervals. These protrusions 66 project outward in the radial direction of the shaft 11, for example, spherically. In such a configuration, when making a cut in the lesion portion by the linear portion 65, it is possible to make the cut easier by using the protrusion 66 as a trigger.
  • FIG. 16A and 16B are side views showing the distal end side of the balloon device 70, where FIG. 16A shows the natural state of the linear portion 72 and FIG. 16B shows the insertable state of the linear portion 72. There is.
  • the balloon device 70 shown in FIG. 16A includes a shaft 71 and a linear portion 72 having one end 73 fixed to the distal end of the shaft 71.
  • the linear portion 72 extends spirally from the one end portion 73 (hereinafter referred to as the fixed end portion 73) fixed to the shaft 71 toward the proximal side.
  • the linear portion 72 has a spiral shape by being wound around the shaft 71.
  • the proximal end portion 74 of the linear portion 72 is a free end. In such a configuration, the linear portion 72 is spirally arranged on the outer peripheral side of the balloon 23.
  • the linear portion 72 can be expanded and contracted in the axial direction of the shaft 71.
  • the linear portion 72 is pulled in the axial direction from the natural state (state of FIG. 16A)
  • the linear portion 72 is in a state of extending along the shaft 71 as shown in FIG. 16B.
  • NS the state of the linear portion 72 is a state in which the linear portion 72 can be inserted.
  • the linear portion 72 is wound around the shaft 71.
  • the balloon device 70 can be introduced into the inner tube 26 by making the linear portion 72 passable. Therefore, even if the linear portion 72 has a spiral structure, the balloon device 70 can be introduced into the body through the inner tube 26.
  • a wire rod 75 for performing an expansion / contraction operation of the linear portion 72 is fixed to the proximal end portion 74 of the linear portion 72.
  • the wire rod 75 is made of, for example, a thread and extends proximally from a fixing site fixed to the linear portion 72 (proximal end portion 74).
  • the wire rod 75 is shown by a broken line (dotted line) for convenience.
  • the linear portion 72 when the wire rod 75 is pulled to the proximal side, the linear portion 72 is pulled in the axial direction of the shaft 71, and as a result, the linear portion 72 is inserted. It is considered possible. Further, when the pulling of the wire rod 75 is stopped, the linear portion 72 naturally contracts in the axial direction to be in a natural state.
  • a connecting portion 82 connecting a plurality of (specifically two) linear portions 81 may be provided.
  • the shaft is not shown for convenience.
  • the connecting portions 82 connect the linear portions 81 in an arc shape, and a plurality (specifically, three) of the linear portions 81 are arranged at predetermined intervals in the length direction of the linear portions 81.
  • the connecting portion 82 is formed of an elastic material, and the linear portions 81 can be bent so as to approach each other (see the two-dot chain line in FIG. 17A).
  • each linear portion 81 and each connecting portion 82 can be folded toward the linear portion 81 in the bent state as described above (see the two-dot chain line in FIG. 17B).
  • each linear portion 81 and each connecting portion 82 can be arranged along the shaft, each linear portion 81 and each connecting portion 82 can be inserted into the inner tube 26 together with the shaft. can.
  • one end of the linear portion is directly fixed to the distal end of the shaft, but as shown in FIG. 18A, for example, one end of the linear portion 86 and the shaft 85 are far apart.
  • a connecting member 87 may be interposed between the position end portion and one end portion of the linear portion 86 may be fixed to the distal end portion of the shaft 85 via the connecting member 87.
  • the connecting member 87 is preferably formed of a material having relatively high strength such as a metal material or a hard resin. Since it is assumed that a relatively large load is applied to the connection portion between one end of the linear portion and the shaft when expanded by the balloon 23, the linear portion 86 falls off from the shaft 85. Etc. can be reliably avoided.
  • the connecting member 87 is provided with a hole that communicates with the tube hole of the shaft 85 and opens at the distal end, and the guide wire straddles the hole and the tube hole. G is inserted. Further, it is desirable that the angle formed by the linear portion 86 with the shaft 85 on the distal side is, for example, 30 ° to 120 °.
  • the connecting member 89 a member having a tapered shape on the distal side may be used.
  • the connecting member 89 has a conical shape (tapered shape) whose outer diameter decreases toward the distal end on the distal side thereof. Since the distal end of the connecting member 89 constitutes the distal end of the balloon device, in this case the balloon device can be facilitated to be inserted into the inner tube 26.
  • a detachable portion may be provided to detachably fix one end (fixed end) of the linear portion to the shaft.
  • the linear portion can be removed from the shaft and placed in the body.
  • the configuration shown in FIG. 19 can be considered as such a detachable portion.
  • suction portions 91 and 92 that attract each other by magnetic force are provided on the linear portion 12 and the shaft 11, respectively. ..
  • Each of these suction portions 91 and 92 is made of, for example, a magnetic material, and the suction portion 91 is provided on the shaft 11 and the suction portion 92 is provided on the linear portion 12.
  • a magnetic force is generated in each of the suction portions 91, 92, and the one end portion 13 of the linear portion 12 is fixed to the shaft 11 by the magnetic force. ..
  • no magnetic force is generated in the suction portions 91 and 92, whereby one end portion 13 of the linear portion 12 is disengaged from the shaft 11.
  • one end portion 13 of the linear portion 12 is detachably fixed to the shaft 11 via the suction portions 91 and 92. Therefore, in this example, the attachment / detachment portion is composed of the suction portions 91 and 92.
  • the stent may be configured by including the removable linear portion described in (9) above.
  • the stent is configured to include each linear portion 81 and each connecting portion 82.
  • one end of each linear portion 81 is fixed to the shaft via the detachable portion, whereby the linear portion 81 can be attached to and detached from the shaft.
  • the stent (linear portion 81 and connecting portion 82) is introduced into the body through the inside of the inner tube 26, placed on the outer peripheral side of the balloon 23, and then expanded by inflating the balloon 23. After that, the stent can be placed in the body by removing each linear portion 81 from the shaft. As a result, when the stent is introduced into the body, it is possible to prevent the tube wall in the body from being damaged.
  • the stent can be introduced into the body while the balloon 23 is placed in the body, when a plurality of stents are placed in the body, the plurality of stents are inserted into the inner tube 26 while the balloon 23 is left in the body. It can be introduced into the body and indwelled through. That is, in this case, it is not necessary to perform the troublesome work of moving the balloon 23 in and out of the body each time each stent is introduced into the body, and the work can be easily performed when each stent is placed in the body. ..
  • the work of introducing the balloon 23 to the place where the stent is placed and aligning the balloon 23 is required, so that the work is expected to take a lot of time and effort. Therefore, even in view of this point, it is significant that the stent can be introduced into the body while the balloon 23 remains in the body.
  • the cross section of the linear portion 81 has a circular shape. In this case, it is possible to reduce the risk of scratching the balloon 23 when the balloon 23 is inflated to expand the linear portion 81 (stent).
  • the shaft is tubular and the tube hole is used as a lumen for the guide wire.
  • the shaft is made into a rod shape (solid state). It may be formed.
  • the balloon device 10 of the present disclosure is used for the over-the-wire type balloon catheter 20, but the proximal end opening of the lumen 26a of the inner tube 26 is the axis of the balloon catheter 20.
  • the balloon device of the present disclosure may be used for a so-called RX type balloon catheter located in the middle of the direction. Also in this case, the balloon device can be inserted into the lumen 26a of the inner tube 26 from the proximal end opening thereof, and the balloon device can be introduced into the body through the lumen 26a.
  • the balloon device does not necessarily have to be introduced into the body through the inner tube 26 (in other words, the guide wire tube) for inserting the guide wire.
  • the balloon device may be introduced into the body through the tube extending in the balloon.
  • the balloon device of the present disclosure includes vessels other than blood vessels such as ureters, vas deferens, and lymphatic vessels. It can also be used for the treatment of.

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  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un dispositif à ballonnet 10 comprend un arbre 11 et une pluralité de parties linéaires 12, dont une partie de première extrémité 13 de chacune est fixée à une partie d'extrémité distale de l'arbre 11. L'arbre 11 est inséré dans un tube intérieur d'un cathéter à ballonnet. Les côtés d'autre extrémité des parties linéaires 12 s'étendent davantage vers un côté proximal que les parties de première extrémité 13 et sont positionnés sur la périphérie extérieure d'un ballonnet. Les parties linéaires 12 sont formées de telle sorte que, lorsqu'elles s'étendent le long de l'arbre 11, les parties linéaires 12 sont dans un état insérable dans lequel les parties linéaires 12 peuvent être insérées conjointement avec l'arbre 11 dans le tube intérieur.
PCT/JP2021/016779 2020-05-19 2021-04-27 Dispositif à ballonnet Ceased WO2021235199A1 (fr)

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JP2020-087464 2020-05-19
JP2020087464 2020-05-19

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040193196A1 (en) * 2003-03-25 2004-09-30 Angiodynamics, Inc, Device and method for converting a balloon catheter into a cutting ballon catheter
JP2007533404A (ja) * 2004-04-21 2007-11-22 ボストン サイエンティフィック リミテッド 摩擦バルーン
EP2455017A1 (fr) * 2010-11-22 2012-05-23 Rex Medical, L.P. Ensemble de découpe de fils pour une utilisation avec un cathéter
JP2012196320A (ja) * 2011-03-22 2012-10-18 Nipro Corp バルーンカテーテル
JP2018535813A (ja) * 2015-11-30 2018-12-06 シー・アール・バード・インコーポレーテッドＣ Ｒ Ｂａｒｄ Ｉｎｃｏｒｐｏｒａｔｅｄ ガイドワイヤとカテーテルとを備える、血管系での医療処置において使用するための装置、および、当該装置の使用方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040193196A1 (en) * 2003-03-25 2004-09-30 Angiodynamics, Inc, Device and method for converting a balloon catheter into a cutting ballon catheter
JP2007533404A (ja) * 2004-04-21 2007-11-22 ボストン サイエンティフィック リミテッド 摩擦バルーン
EP2455017A1 (fr) * 2010-11-22 2012-05-23 Rex Medical, L.P. Ensemble de découpe de fils pour une utilisation avec un cathéter
JP2012196320A (ja) * 2011-03-22 2012-10-18 Nipro Corp バルーンカテーテル
JP2018535813A (ja) * 2015-11-30 2018-12-06 シー・アール・バード・インコーポレーテッドＣ Ｒ Ｂａｒｄ Ｉｎｃｏｒｐｏｒａｔｅｄ ガイドワイヤとカテーテルとを備える、血管系での医療処置において使用するための装置、および、当該装置の使用方法

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