WO2017154909A1 - 医療デバイスおよび処置方法 - Google Patents
医療デバイスおよび処置方法 Download PDFInfo
- Publication number
- WO2017154909A1 WO2017154909A1 PCT/JP2017/009016 JP2017009016W WO2017154909A1 WO 2017154909 A1 WO2017154909 A1 WO 2017154909A1 JP 2017009016 W JP2017009016 W JP 2017009016W WO 2017154909 A1 WO2017154909 A1 WO 2017154909A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- shaft
- slide
- crushing
- distal
- medical device
- Prior art date
Links
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B17/32—Surgical cutting instruments
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- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
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- A—HUMAN NECESSITIES
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- 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
- A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
- A61B2017/22039—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire eccentric
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
- A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
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- A—HUMAN NECESSITIES
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- 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
- A61B2017/320716—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions comprising means for preventing embolism by dislodged material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
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- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B2017/320733—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
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- 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
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
- A61B2017/320775—Morcellators, impeller or propeller like means
Definitions
- the present invention relates to a medical device used for crushing a body lumen object and a treatment method using the medical device.
- a thrombus occurs in the body lumen, it must be removed promptly.
- symptoms in which a thrombus occurs in a living body lumen include deep vein thrombosis in which a thrombus occurs in a vein deep in the body such as a femoral vein and a popliteal vein.
- a method for treating deep vein thrombosis a method is known in which a long tube of a medical device is inserted into a blood vessel, a drug such as a thrombolytic agent is injected into an embolus, and the thrombus is dissolved to remove it. It has been.
- the member that mechanically destroys the thrombus is a curved wire. It is preferable that the wire can be deformed linearly in order to reach the target position. Therefore, the first end portion of the wire is fixed to the shaft portion, but the second end portion of the wire is not fixed to the shaft portion. For this reason, when the shaft portion is rotated, the wire receives a reaction force due to contact with the thrombus and twists and deforms, so that the range in which the thrombus can be crushed by the wire changes.
- the present invention has been made to solve the above-described problems, and an object thereof is to provide a medical device that can appropriately maintain a range in which an object generated in a living body lumen can be crushed and a treatment method using the medical device. .
- a medical device that achieves the above object is a device that is inserted into a living body lumen to crush an object in the living body lumen, and has a long shaft portion that is rotationally driven and a bendable body.
- a crushing portion that is provided with a wire and is rotatable with the shaft portion, and is fixed to each of at least one of the distal and proximal ends of the wire, and is slidable along the axial direction of the shaft portion.
- a slide portion connected to the shaft portion, and the shaft portion has a contact portion that contacts the slide portion during rotation and restricts relative rotation of the shaft portion and the slide portion. After the slide portion comes into contact with the contact portion, the slide portion rotates in the same direction as the shaft portion in accordance with the rotation of the shaft portion.
- a treatment method according to the present invention that achieves the above object is a treatment method for crushing an object generated in a lesioned part of a living body lumen using the medical device, wherein the shaft part is transferred to the living body lumen. Inserting and delivering the crushing part to the lesioned part; rotating the shaft part; abutting the slide part against the contact part of the shaft part; and Crushing the object by simultaneously rotating the end and the proximal end to contact the object.
- the contact portion of the shaft portion contacts the slide portion, and relative rotation of the shaft portion and the slide portion is limited.
- the crushing portion is not easily twisted even when an external force is applied in the rotation direction, and is not easily deformed. Therefore, the range in which the object in the living body lumen can be crushed by the crushing portion can be appropriately maintained.
- FIG. 3 is a cross-sectional view taken along line AA in FIG. 2. It is a disassembled perspective view which shows the component of a slide part. 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.
- FIG. 10 is a cross-sectional view showing a modified example of the medical device, in which (A) is a third modified example in which the cross-sectional shapes of the shaft portion and the slide portion are elliptical, and (B) is a first cross-sectional shape of the shaft portion and the slide portion having a square shape. 4 shows a modification. It is sectional drawing which shows the 5th modification of a medical device. It is a top view which shows the 6th modification of a medical device. It is a perspective view which shows the 7th modification of a medical device. It is sectional drawing which follows the BB line of FIG.
- FIG. 1 Shows the state of being housed. It is a perspective view which shows the state at the time of contracting the crushing part of a 9th modification, (A) is the state in which the crushing part was partially accommodated in the outer sheath, (B) is a crushing part completely outside sheath. Shows the state of being housed. It is a top view which shows the 10th modification of a medical device. It is a perspective view which shows the state at the time of expanding the crushing part of a 10th modification, (A) is the state in which the crushing part was accommodated in the outer sheath, (B) is a crushing part partially discharge
- FIG. 1 It is a perspective view which shows the state at the time of contracting the crushing part of a 10th modification, (A) is the state in which the crushing part was partially accommodated in the outer sheath, (B) is the crushing part completely outer sheath. Shows the state of being housed.
- the medical device 10 is inserted into a blood vessel in deep vein thrombosis, and is used for a treatment for crushing and removing the thrombus.
- the side of the device that is inserted into the blood vessel is referred to as the “distal side”
- the proximal side that is operated is referred to as the “proximal side”.
- 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.
- the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.
- 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 (first tube), a shaft inner tube 30, and a guide wire tube 40 (convex portion, second 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.
- 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 (first lumen) 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 along 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 shaft inner tube 30 has a suction lumen 32 that generates a suction force in a negative pressure state.
- the shaft inner tube 30 is movable in the axial direction with respect to the shaft outer 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.
- a cutting portion 31 is provided in the suction lumen 32 at 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 body 40 is arranged to be fixed 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 41 (second lumen) into which a guide wire can be inserted.
- 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.
- 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
- ETFE ethylene / tetrafluoroethylene copolymer
- PEEK polyetheretherketone
- polyimide polyimide
- the outer sheath 90 can accommodate the shaft portion 20 while reducing 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.
- 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
- the crushing portion 60 is provided at the distal portion of the shaft outer tube 21.
- the crushing part 60 includes a plurality of spiral parts 61.
- Each of the spiral portions 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 of the curved axial direction 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.
- 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.
- the spiral part 61 reduces the swelling of the center part along an axial direction, and approaches the outer peripheral surface of the shaft outer tube
- 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.
- the spiral portion 61 is made of a material having shape memory properties.
- a shape memory alloy, stainless steel, or the like to which a shape memory effect or superelasticity is imparted by heat treatment is suitable.
- the shape memory alloy Ni—Ti, Cu—Al—Ni, Cu—Zn—Al, a combination thereof, or the like is preferable.
- the slide portion 50 has a C-shaped cross section perpendicular to the axial direction of the shaft portion 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” differs in structure from a groove that does not penetrate, in that it penetrates from the first direction to the second direction in the thickness direction.
- the slide part 50 includes a slide center part 51 provided with a plurality of receiving recesses 54 in which the respective spiral parts 61 are housed, a slide inner part 52 disposed inside the slide center part 51, and an outer side of the slide center part 51.
- the slide outer portion 53 is provided.
- the slide center portion 51 has an accommodation recess 54 in which each spiral portion 61 is accommodated, and a first slit 55 in which the guide wire tubular body 40 is accommodated.
- the accommodation recess 54 of the slide center portion 51 has an end portion at a predetermined length from the proximal side in the central axis direction.
- the crushing part 60 can be made into a fixed diameter by making the front-end
- the position of the edge part of the some accommodating recessed part 54 can each be changed. Specifically, the predetermined length from the proximal opening to the distal end of the plurality of receiving recesses 54 can be changed.
- the predetermined length from the proximal opening to the distal end of the plurality of receiving recesses 54 can be gradually increased in the order in which they are arranged in the circumferential direction. Alternatively, the predetermined length can be alternately changed from the proximal opening to the distal end of the plurality of receiving recesses 54.
- the accommodation recessed part which accommodates the helical part 61 may penetrate from the proximal side to the distal side in the central axis direction.
- the accommodating recesses 54 are arranged in the circumferential direction of the slide center portion 51.
- the accommodation recess 54 has a size that can accommodate the spiral portion 61.
- the 1st slit 55 of the slide center part 51 has penetrated from the proximal side of the axial direction to the distal side.
- the slide inner portion 52 is disposed inside the slide central portion 51, and the outer peripheral surface of the slide inner portion 52 is in contact with the inner peripheral surface of the slide central portion 51.
- the slide inner portion 52 has a second slit 56 for accommodating the guide wire tube 40.
- the second slit 56 penetrates from the proximal side to the distal side of the slide inner portion 52 in the axial direction.
- the inner peripheral surface of the slide inner portion 52 is slidably in contact with the outer peripheral surface of the shaft outer tube 21.
- the clearance between the inner peripheral surface of the slide inner portion 52 and the outer peripheral surface of the shaft outer tube 21 is, for example, 0.02 mm to 0.1 mm.
- the slide outer portion 53 is disposed outside the slide central portion 51, and the inner peripheral surface of the slide outer portion 53 is in contact with the outer peripheral surface of the slide central portion 51.
- the slide outer portion 53 has a third slit 57 that accommodates the guide wire tube 40.
- the third slit 57 penetrates the slide outer portion 53 from the proximal side in the axial direction to the distal side.
- the slide central portion 51, the slide inner portion 52, and the slide outer portion 53 are aligned with the first slit 55, the second slit 56, and the third slit 57, and the distal end of the spiral portion 61 is inserted into each receiving recess 54. In this state, it is fixed with an adhesive or the like.
- the first slit 55, the second slit 56, and the third slit 57 constitute one slit 58.
- the inner peripheral surface of the slide inner portion 52 is slidably in contact with the outer peripheral surface of the shaft outer tube 21.
- the guide wire tubular body 40 (convex portion) is accommodated in the slit 58 of the slide portion 50.
- the distal portion of the spiral portion 61 is fixed to the slide portion 50 and the slide portion 50 can slide on the outer peripheral surface of the shaft outer tube 21.
- the contact portion 42 which is a part of the outer peripheral surface of the guide wire tubular body 40 comes into contact with the end surface 59 constituting the edge portion of the slit 58.
- relative rotation of the slide part 50 and the shaft part 20 is restrict
- the relative rotation angle between the slide part 50 and the shaft part 20 is preferably 180 degrees or less, more preferably 90 degrees or less, and further preferably 4 degrees or less. Therefore, the clearance between the end face 59 of the slit 58 and the contact portion 42 of the guide wire tube 40 is preferably set to have such a relative rotation angle.
- the radius from the center of the shaft outer tube 21 that is the rotation center to the nearest outer peripheral surface of the shaft portion 20 (the outer peripheral surface of the shaft outer tube 21) is r1, and the farthest outer peripheral surface of the shaft portion 20 (the guide wire tube 40).
- r2 is the radius to the outer peripheral surface of the slide portion 50
- ri is the radius of the inner peripheral surface having the smallest radius of the slide portion 50.
- the radius r1 of the outer peripheral surface of the shaft outer tube 21 is larger than the radius r3 of the outer peripheral surface of the guide wire tube 40.
- the guide wire tube 40 having a smaller radius than the outer shaft tube 21 can be effectively used as a convex portion that fits into the slit 58.
- the outer diameter of the shaft outer tube 21 is larger than the width between the opposing end surfaces 59 constituting the edge of the slit 58. Thereby, it can suppress that the shaft outer tube
- the outer diameter of the guide wire tube 40 is smaller than the width of the slit 58. Thereby, the guide wire tube 40 can be favorably moved inside the slit 58.
- the constituent material of the slide center portion 51, the slide inner portion 52 and the slide outer portion 53 is not particularly limited as long as the shape can be maintained.
- polyolefin such as stainless steel, aluminum, polyethylene and polypropylene, polyester such as polyamide and polyethylene terephthalate, Fluorine polymers such as ETFE, PEEK, polyimide, and the like are suitable.
- the slide center part 51, the slide inner part 52, and the slide outer part 53 may be made of different materials.
- the slide inner portion 52 is made of a fluorine-based polymer having a low friction coefficient so that it can easily slide with the shaft portion 20, and the slide outer portion 53 is made of a flexible resin material so as not to damage the blood vessel.
- the central portion 51 can be made of stainless steel having high rigidity so that the spiral portion 61 can be satisfactorily held.
- 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.
- the shaft outer tube 21 rotates in the circumferential direction.
- 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.
- the blood flow can alternately turn in the opposite direction.
- 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.
- 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.
- the filter 112 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.
- 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.
- the proximal end portion of the wire portion 113 is inserted into the guide wire lumen 41 (see FIG. 4) of the medical device 10.
- the medical device 10 is made to reach the proximal side of the thrombus 300 using the wire portion 113 as a guide.
- the outer sheath 90 is moved proximally with respect to the shaft portion 20, as shown in FIG. 7B, the crushing portion 60 is exposed to the outside of the outer sheath 90 and is expanded by its own elastic force. To do.
- the slide part 50 moves to the proximal side with respect to the shaft part 20.
- the crushing part 60 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.
- the crushing portion 60 contacts the thrombus 300, and the crushing portion 60 crushes in a state where the crushing portion 60 is fixed in the blood vessel. If the crushing part 60 continues to rotate, the blood flow is restricted by the filter device 110, and therefore, as shown in FIG. 8, 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.
- the crushing part 60 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. That is, when the shaft portion 20 rotates, the contact portion 42 of the shaft portion 20 comes into contact with the end face 59 of the slit 58 of the slide portion 50 (see FIG. 5), and relative rotation of the slide portion 50 with respect to the shaft portion 20 occurs. Limited.
- the bulge (outer diameter) of the crushing portion 60 increases and the range in which the thrombus can be crushed increases.
- the spiral portion 61 is twisted in the direction in which the spiral of the spiral portion 61 is strengthened (the direction opposite to the direction in which the spiral is unwound), the bulge (outer diameter) of the crushing portion 60 is reduced and the range in which the thrombus can be crushed is reduced. .
- the crushing part 60 is hard to be twisted, so that 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.
- the crushing part 60 moves forward or backward in the blood vessel whose inner diameter changes, the outer diameter of the crushing part 60 changes according to the inner diameter of the blood vessel.
- the slide portion 50 moves forward or backward along the shaft portion 20 in the axial direction. Further, the crushing portion 60 rotates in the circumferential direction and crushes the thrombus 300 while changing the outer diameter by the movement of the slide portion 50.
- the pusher of the syringe 100 (see FIG. 1) is pulled to bring the suction lumen 32 of the 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. 9, a part of the thrombus 301 drawn to the opening 22 enters the hollow interior of the shaft outer tube 21.
- the shaft inner tube 30 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.
- the shaft inner tube 30 is moved from the position 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.
- the shaft inner tube 30 When the shaft 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. It fits in the suction lumen 32. 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.
- 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 by the suction lumen 32 of the shaft inner tube 30.
- the cut thrombus 302 moves the suction lumen 32 of the intra-shaft tube 30 to the proximal side. Move towards. 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 aspirated while being finely cut by repeating the reciprocating motion of the inner tube 30 in the axial direction.
- 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 of the suction lumen 32 of the shaft inner tube 30, and a vortex swirl flow is also generated inside the shaft inner tube 30. As a result, the flow resistance in the axial direction is reduced inside the shaft inner tube 30, and the cut thrombus 302 can be sucked smoothly.
- 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 added. May be.
- 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.
- a wider range of the thrombus 300 can be crushed and stirred.
- the reciprocating and rotating motions of the shaft outer tube 21 and the shaft inner tube 30 are stopped.
- the crushing part 60 is accommodated in the outer sheath 90, and the medical device 10 is extracted from the blood vessel.
- the filter device 110 is accommodated in a sheath or the like and removed from the blood vessel, and the treatment is completed.
- the medical device 10 is a device that is inserted into a biological lumen to crush an object in the biological lumen, and is a long shaft portion 20 that is rotationally driven.
- a slide portion 50 connected to the shaft portion 20 so as to be slidable along the axial direction of the shaft portion 20, and a first end portion is fixed to the shaft portion 20 and a second end portion is fixed to the slide portion 50.
- a crushing portion 60 that can be rotated together with the shaft portion 20, and the shaft portion 20 contacts the slide portion 50 during rotation and is relative to the shaft portion 20 and the slide portion 50. After the slide part 50 comes into contact with the contact part 42, the slide part 50 rotates in the same direction as the shaft part 20 in accordance with the rotation of the shaft part 20.
- the contact portion 42 of the shaft portion 20 comes into contact with the slide portion 50 and relative rotation of the shaft portion 20 and the slide portion 50 is limited. .
- the crushing part 60 becomes difficult to twist even if it receives external force in the rotation direction, and deformation hardly occurs, the range that can be crushed by the crushing part 60 can be appropriately maintained.
- the crushing part 60 rotates together with the shaft part 20 in a state where the circumferential positions of the first end part and the second end part of the crushing part 60 are fixed with respect to the shaft part 20. Thereby, the relative positional relationship between the first end portion and the second end portion of the crushing portion 60 does not change. For this reason, the twist of the crushing part 60 at the time of rotation can be reduced more reliably, and the range which can be crushed by the crushing part 60 can be maintained appropriately.
- the slide part 50 is provided with a slit 58 along the axial direction of the shaft part 20.
- the shaft portion 20 is provided with a guide wire tube 40 (convex portion) that is slidably fitted into the slit 58. Accordingly, since the guide wire tube 40 can slide in the slit 58, the slide portion 50 and the shaft portion 20 can be rotated relative to each other while the slide portion 50 can be moved in the axial direction along the shaft portion 20. Can be suppressed.
- the shaft portion 20 is provided with a guide wire tube 40 (convex portion).
- the shaft portion 20 has two lumens (the lumen 24 and the guide wire lumen 41) inside, and one lumen (the guide wire lumen 41) is located inside the guide wire tubular body 40.
- the guide wire tubular body 40 having the guide wire lumen 41 can be used as a member that fits into the slit 58, and the configuration can be arranged without waste to reduce the diameter of the device.
- the contact part 42 comes into contact with an end face 59 constituting the edge of the slit 58. For this reason, the rotational force can be transmitted from the contact portion 42 to the end face 59 with high efficiency.
- the radius r3 of the portion that fits into the slit 58 of the shaft portion 20 is smaller than the radius r1 of the shaft portion 20 located inside the slide portion 50. Therefore, the site
- the shaft portion 20 includes a shaft outer tube 21 (first tube) having a lumen 24 (first lumen) therein, and a convex portion that fits into the slit 58 and has a guide wire lumen 41 (inside).
- the guide wire tube 40 having a smaller radius than the outer shaft tube 21 can be effectively used as a convex portion that fits into the slit 58.
- the outer diameter of the shaft outer tube 21 (first tube) is larger than the width between the opposing end surfaces 59 constituting the edge of the slit 58, and the guide wire tube 40 (second tube). Is smaller than the width of the slit 58. Since the outer diameter of the shaft outer tube 21 is larger than the width of the slit 58, the shaft outer tube 21 can be prevented from deviating from the slit 58. Further, since the guide wire tube 40 has an outer diameter smaller than the width of the slit 58, the guide wire tube 40 can be favorably moved inside the slit 58.
- the present invention also provides a treatment method for crushing an object generated at a lesion in a living body lumen using the medical device 10 described above.
- the method includes the steps of inserting the shaft portion 20 into a living body lumen and delivering the crushing portion 60 to a lesioned portion, and rotating the crushing portion 60 by the shaft portion 20 to contact the object to crush the object. And having.
- the treatment method configured as described above when the shaft portion 20 rotates, the contact portion 42 of the shaft portion 20 comes into contact with the slide portion 50 and the relative rotation of the shaft portion 20 and the slide portion 50 is limited. For this reason, since the crushing part 60 becomes difficult to twist even if it receives external force in the rotation direction, and deformation hardly occurs, the range that can be crushed by the crushing part 60 can be appropriately maintained.
- 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.
- the shape of the shaft portion and the slide portion is not limited as long as the relative rotation of the shaft portion and the slide portion can be restricted when the shaft portion rotates. Therefore, as shown in FIG. 13, the guide wire is such that the end surface 132 (the surface constituting the edge of the slit 131) of the slit 131 of the slide portion 130 is in surface contact with the contact portion 42 of the guide wire tubular body 40.
- the tube body 40 may have a curved surface shape (surface shape) corresponding to the outer surface.
- the shaft part 20 contacts with the slide part 130 in a wide area, and a rotational driving force can be transmitted effectively.
- symbol is attached
- the position of the slide portion 140 that contacts the contact portion 42 of the shaft portion 20 may be a groove 141 provided on the inner peripheral surface instead of the slit.
- symbol is attached
- the shape of the outer peripheral surface of the shaft portion 150 and the inner peripheral surface of the slide portion 160 may be elliptical in a cross section orthogonal to the axial direction. As described above, the shapes of the outer peripheral surface of the shaft portion 150 and the inner peripheral surface of the slide portion 160 are non-circular, so that either of the outer peripheral surfaces of the shaft portion 150 comes into contact with the slide portion 160 and is relative. A contact portion 151 for restricting rotation. Further, as shown in FIG. 15B, the shape of the outer peripheral surface of the shaft portion 170 and the inner peripheral surface of the slide portion 180 may be a quadrangle in a cross section orthogonal to the axial direction.
- the shapes of the outer peripheral surface of the shaft portion 170 and the inner peripheral surface of the slide portion 180 are non-circular, so that either of the outer peripheral surfaces of the shaft portion 170 contacts the slide portion 180 and is relatively A contact portion 171 for restricting rotation.
- the outer peripheral surfaces of the shaft portion and the slide portion may have other shapes as long as they are non-circular in the cross section orthogonal to the axial direction.
- the slide portion 190 may have a convex portion 191 on the inner peripheral surface
- the shaft portion 200 may have a concave portion 201 into which the convex portion 191 is fitted.
- the concave portion 201 becomes a contact portion that comes into contact with the convex portion 191 and restricts relative rotation of the slide 190 and the shaft portion 200.
- the medical device may further include a film-like cover portion 210 that is fixed to at least a part of the outer peripheral surface of the crushing portion 60.
- the cover part 210 restricts the flow of blood in the blood vessel.
- the change in the diameter of the cover portion 210 can be suppressed by suppressing the twist of the slide portion 50 with respect to the shaft portion 20.
- the function of suppressing the flow by the cover part 210 can be favorably maintained.
- symbol is attached
- the shaft portion 220 located inside the slide portion 50 may have a guide wire lumen 221.
- a solid member 222 can be applied as a convex portion in contact with the end face 59 of the slit 58 instead of the guide wire tube.
- the slide unit 50 does not include a suction mechanism, and the thrombus 301 is sucked by the outer sheath 90.
- the outer sheath 90 can suck the thrombus 301 from the distal opening to the inner lumen 91.
- the lumen 91 preferably has a sufficient size so that the suction force can be exerted even when the shaft portion 220 and the solid member 222 are accommodated therein.
- the shaft portion 220 located inside the slide portion 50 has a guide wire lumen 221, and the solid member 223 that is a convex portion spirals along the peripheral surface of the shaft portion 220.
- the spiral convex portion 224 can function as a stopper that restricts the movement of the slide portion 50 in the distal direction.
- the slide part 50 moves in the axial direction along the spiral convex part 224, the slide part 50 rotates along the spiral convex part 224.
- the outer diameter of the crushing part 60 changes.
- the crushing part 60 can be further expanded or contracted by moving the slide part 50 along the spiral convex part 224 in the axial direction.
- a long member 230 is inserted through the lumen 91 of the outer sheath 90 or the like.
- the slide part 50 can be moved to the axial direction along the spiral convex part 224 by pushing the slide part 50 with the member 230.
- a slide part 241 that can slide with respect to the shaft part 240 may be coupled to the proximal end of the crushing part 60.
- the slide part 241 the cross section orthogonal to the axial direction of the shaft part 240 is C-shaped like the above-mentioned embodiment.
- the guide wire lumen is provided inside the shaft portion 240.
- the distal end of the crushing part 60 is fixed to the shaft part 240 by a connecting part 242.
- the connecting part 242 does not slide with respect to the shaft part 240.
- a convex portion 243 extending in the axial direction is fixed in a range in which the slide portion 241 on the outer peripheral surface of the shaft portion 240 can move.
- the convex portion 243 has a contact portion that can contact the end face of the slit 244 of the slide portion 241.
- the convex part 243 suppresses the rotation of the slide part 241 relative to the shaft part 240.
- a ring-shaped distal side restricting portion 245 is fixed to the distal side of the convex portion 243 on the outer peripheral surface of the shaft portion 240.
- the distal restriction unit 245 contacts the slide part 241 and restricts the movement of the slide part 241 to the distal side. By restricting the movement of the slide part 241 to the distal side, the crushing part 60 can be prevented from being excessively expanded.
- a ring-shaped proximal side restriction portion 246 is fixed to the proximal side of the convex portion 243 on the outer peripheral surface of the shaft portion 240.
- the proximal side restriction part 246 contacts the slide part 241 and restricts the movement of the slide part 241 to the proximal side. By restricting the movement of the slide part 241 to the proximal side, it is possible to suppress the crushing part 60 from being extended in the axial direction and being damaged.
- the slide portion 241 is fixed to the distal portion of the operating long body 247.
- the operating long body 247 accommodates the shaft portion 240 in a movable manner.
- a part of the proximal side restriction portion 246 and the convex portion 243 is accommodated in the operation long body 247. Further, the operating long body 247 is movably accommodated in the outer sheath 90. The proximal end portion of the operating elongated body 247 is located closer to the proximal side than the outer sheath 90. Therefore, it is possible to operate the proximal portion of the operating elongated body 247 at hand.
- the shape of the convex portion 243 is not particularly limited as long as the slide portion 241 can slide.
- the shapes of the distal side restriction part 245 and the proximal side restriction part 246 are not particularly limited as long as the movement of the slide part 241 can be restricted.
- the slide part 241 contacts or approaches the proximal side restriction part 246, as shown in FIG.
- the outer sheath 90 is moved proximally with respect to the shaft part 240.
- the crushing part 60 is exposed to the outside of the outer sheath 90 and expands by its own elastic force.
- the length of the axial direction of the crushing part 60 becomes short.
- the slide part 241 moves distally with respect to the shaft part 240 and abuts or approaches the distal restriction part 245.
- the operation elongated body 247 also moves to the distal side.
- the relative rotation of the slide portion 241 with respect to the shaft portion 240 is limited by the convex portion 243.
- the force which expands to radial direction by crushing the crushing part 60 to an axial direction does not become so big. Therefore, by using the operation elongated body 247, the crushing portion 60 can be smoothly accommodated in the outer sheath 90 as shown in FIG. For this reason, the force which acts on a medical device can be reduced and generation
- the slide part 241 comes into contact with or is close to the proximal restriction part 246.
- the position of the shaft part 240 instead of the operation elongated body 247 may be fixed and the outer sheath 90 may be moved to the distal side.
- the distal end of the outer sheath 90 contacts the crushing portion 60, and the crushing portion 60 is deformed in the distal direction and the contraction direction, as shown in FIG.
- the connecting portion 242 does not move because the shaft portion 240 is fixed. For this reason, the crushing force acts strongly on the crushing portion 60 without escaping between the connecting portion 242 and the slide portion 241.
- the medical device may have the elongated operating body 247 that extends along the shaft portion 240 and has a distal portion fixed to the slide portion 241.
- the position of the slide part 241 can be controlled by operating the operating long body 247.
- the connection part 242 fixed to the slide part 241 can be freely moved. Therefore, particularly when the crushing part 60 is accommodated, the crushing part 60 can be smoothly accommodated in the outer sheath 90.
- the force which acts on a medical device can be reduced and damage to a medical device can be suppressed.
- the medical device may be provided with a first slide part 251 and a second slide part 252 that are slidable along the shaft part 250.
- the proximal slide portion 251 and the distal slide portion 252 have a C-shaped cross section perpendicular to the axial direction of the shaft portion 250 as in the above-described embodiment.
- the proximal end of the crushing part 60 is fixed to the proximal slide part 251.
- the distal end of the crushing portion 60 is fixed to the distal slide portion 252.
- a proximal convex portion 253 extending in the axial direction is fixed in a range in which the proximal slide portion 251 on the outer peripheral surface of the shaft portion 250 can move.
- the proximal convex portion 253 has a contact portion that can contact the end surface of the slit of the proximal slide portion 251.
- the proximal convex part 253 suppresses the rotation of the proximal slide part 251 with respect to the shaft part 250.
- a ring-shaped first distal-side restricting portion 254 is fixed to the distal side of the proximal convex portion 253 on the outer peripheral surface of the shaft portion 250.
- the first distal restriction unit 254 restricts the movement of the proximal slide unit 251 to the distal side.
- a ring-shaped first proximal side restricting portion 255 is fixed on the proximal side of the proximal convex portion 253 on the outer peripheral surface of the shaft portion 250.
- the first proximal restriction portion 255 restricts the movement of the proximal slide portion 251 to the proximal side.
- a distal convex portion 256 extending in the axial direction is fixed in a range in which the distal slide portion 252 on the outer peripheral surface of the shaft portion 250 can move.
- the distal convex portion 256 has a contact portion that can contact the end surface of the slit of the distal slide portion 252.
- the distal convex portion 256 suppresses rotation of the distal slide portion 252 with respect to the shaft portion 250.
- a ring-shaped second distal side restricting portion 257 is fixed to the distal side of the distal convex portion 256 on the outer peripheral surface of the shaft portion 250.
- the second distal restriction unit 257 restricts the movement of the distal slide unit 252 to the distal side.
- a ring-shaped second proximal side limiting portion 258 is fixed on the proximal side of the distal convex portion 256 on the outer peripheral surface of the shaft portion 250.
- the second proximal restriction portion 258 restricts the movement of the distal slide portion 252 to the proximal side.
- the proximal convex portion 253 and the distal convex portion 256 are different convex portions and are separated in the axial direction.
- the proximal convex portion 253 and the distal convex portion 256 may or may not be located on the same axis.
- the shape of the proximal convex part 253 and the distal convex part 256 will not be specifically limited if the proximal side slide part 251 and the distal side slide part 252 are slidable.
- the shapes of the first proximal restriction part 255 and the first distal restriction part 254 are not particularly limited as long as the movement of the proximal slide part 251 can be restricted.
- limiting part 258 will not be specifically limited if the movement of the distal side slide part 252 can be restrict
- the proximal slide part 251 abuts or approaches the first proximal restriction part 255 as shown in FIG. Further, the distal slide portion 252 abuts or approaches the second distal restriction portion 257.
- the outer sheath 90 is moved proximally with respect to the shaft portion 250.
- the proximal slide portion 251 abuts on the first proximal restriction portion 255, and the crushing portion 60 is gradually released from the outer sheath 90, so that its own elasticity is obtained. Expand by force.
- the length of the axial direction of the crushing part 60 becomes short.
- the distal slide part 252 moves proximally and abuts on the second proximal restriction part 258.
- the crushing portion 60 is released from the outer sheath 90 and expands by its own elastic force, as shown in FIG.
- the length of the crushing part 60 in the axial direction is further shortened, the proximal slide part 251 moves to the distal side, and comes into contact with the first distal restriction part 254.
- the crushing part 60 expands completely.
- the proximal slide portion 251 and the distal slide portion 252 are limited in relative rotation with respect to the shaft portion 250 by the proximal convex portion 253 and the distal convex portion 256.
- the shaft part 250 When accommodating the crushing part 60 in the outer sheath 90, the shaft part 250 is fixed by hand and the outer sheath 90 is moved to the distal side.
- the crushing portion 60 When the distal end portion of the outer sheath 90 contacts the crushing portion 60, the crushing portion 60 is deformed in the distal direction and the contraction direction, as shown in FIG. Thereby, the length of the axial direction of the crushing part 60 becomes long.
- the distal side slide part 252 moves to the distal side and contacts the second distal side restriction part 257.
- the distal slide portion 252 contacts the second distal limit portion 257, the distal slide portion 252 cannot move with respect to the shaft portion 250.
- the crushing portion 60 is subjected to an axial crushing force between the distal slide portion 252 and the proximal slide portion 251.
- the crushing portion 60 is completely accommodated in the outer sheath 90 while contracting in the radial direction, and the length in the axial direction is increased. Therefore, the proximal slide portion 251 moves proximally and abuts or approaches the first proximal restriction portion 255.
- the contact portions of the proximal convex portion 253 and the distal convex portion 256 that contact each of the proximal slide portion 251 and the distal slide portion 252 are arranged separately in the axial direction. ing. Thereby, the movement distance of the proximal side slide part 251 and the distal side slide part 252 which move to an axial direction in order to expand the crushing part 60 can be disperse
- the medical device also includes a first distal restriction 254 and a second distal restriction that restrict distal movement of the proximal slide 251 and the distal slide 252 relative to the shaft 250.
- the distal limiter (first distal limiter 254) that limits the movement of the slide parts (slide part 251 and distal slide part 252) to the distal side with respect to the shaft part 250.
- the second distal limiter 257) are provided, but only one of them may be provided.
- limiting part (1st proximal side restriction
- the second proximal limiter 258) are provided, but only one of them may be provided.
- 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 vascular tube, a ureter, a bile duct, a fallopian tube, a hepatic tube, or the like.
- the medical device may not have a suction function.
- the slide portion may be connected to the proximal end portion instead of the distal end portion of the crushing portion.
- the shaft portion may be provided with three or more lumens, or may be provided with only one lumen.
- the slide portion does not necessarily have to be constituted by three members (the slide center portion 51, the slide inner portion 52, and the slide outer portion 53).
Abstract
Description
r1<ri<r2 ・・・式(1)
20、150、170、200、220、240、250 シャフト部、
21 シャフト外管(第1の管体)、
24 ルーメン(第1のルーメン)、
30 シャフト内管、
40 ガイドワイヤ用管体(凸部、第2の管体)、
41 ガイドワイヤルーメン(第2のルーメン)、
42、151、171 接触部、
50、130、140、160、180、190、241 スライド部、
54 収容凹部、
58、131、244 スリット、
59、132 端面、
60 破砕部、
61 螺旋部、
62、242 連結部、
141 溝、
191、243 凸部、
201 凹部、
210 フィルタ、
222、223 中実の部材(凸部)、
224 螺旋凸部(凸部)、
245 遠位側制限部、
246 近位側制限部、
247 操作用長尺体、
251 近位側スライド部、
252 遠位側スライド部、
253 近位凸部、
254 第1の遠位側制限部、
255 第1の近位側制限部、
256 遠位凸部、
257 第2の遠位側制限部、
258 第2の近位側制限部、
300、301、302 血栓、
r1 シャフト外管の半径、
r3 ガイドワイヤ用管体の半径。
Claims (11)
- 生体管腔に挿入されて当該生体管腔の物体を破砕するための医療デバイスであって、
回転駆動される長尺なシャフト部と、
湾曲可能な線材を備え、前記シャフト部とともに回転可能な破砕部と、
前記線材の遠位側および近位側の少なくとも一方の端部の各々に固定され、前記シャフト部の軸方向に沿ってスライド可能に前記シャフト部に連結されているスライド部と、を有し、
前記シャフト部は、回転時に前記スライド部に接触して前記シャフト部および前記スライド部の相対的な回転を制限する接触部を有し、
前記スライド部が前記接触部に当接後、前記スライド部は前記シャフト部の回転に合わせて前記シャフト部と同方向に回転する医療デバイス。 - 前記破砕部の遠位側の端部と近位側の端部の周方向の位置が前記シャフト部に対して固定された状態で、前記破砕部が前記シャフト部とともに回転する請求項1に記載の医療デバイス。
- 2つの前記スライド部の各々に接触する前記接触部は、軸方向に分かれている請求項1または2に記載の医療デバイス。
- 前記スライド部の前記シャフト部に対する遠位側への移動を制限する少なくとも1つの遠位側制限部と、
前記スライド部の前記シャフト部に対する近位側への移動を制限する少なくとも1つの近位側制限部と、を有する請求項1~3のいずれか1項に記載の医療デバイス。 - 前記シャフト部に沿って延在し、遠位部が前記スライド部に固定されている操作用長尺体を有する請求項1~4のいずれか1項に記載の医療デバイス。
- 前記スライド部およびシャフト部の一方は、前記シャフト部の軸方向に沿ってスリットまたは溝が設けられ、
前記スライド部およびシャフト部の他方は、前記スリットまたは溝にスライド可能に嵌合する凸部が設けられた請求項1~5のいずれか1項に記載の医療デバイス。 - 前記スライド部は、前記スリットまたは溝が設けられ、
前記シャフト部は、前記凸部が設けられるとともに2つのルーメンを内部に有し、前記ルーメンの1つが前記凸部の内部に位置する請求項6に記載の医療デバイス。 - 前記接触部は、前記スリットまたは溝の縁を構成する端面に当接する請求項6または7に記載の医療デバイス。
- 前記シャフト部は、内部に第1のルーメンを有する第1の管体と、前記凸部であって内部に第2のルーメンを有して前記第1の管体と隣接する第2の管体と、を有し、
前記第1の管体の外周面の半径は、前記第2の管体の外周面の半径よりも大きい請求項6~8のいずれか1項に記載の医療デバイス。 - 前記第1の管体の外径は、前記スリットまたは溝の縁を構成する対向する端面の間の幅よりも大きく、
前記第2の管体の外径は、前記スリットまたは溝の幅よりも小さい請求項9に記載の医療デバイス。 - 請求項1に記載の医療デバイスを使用して生体管腔の病変部に生じた物体を破砕するための処置方法であって、
前記シャフト部を生体管腔へ挿入し、前記破砕部を病変部に送達するステップと、
前記シャフト部を回転させ、前記スライド部を前記シャフト部の接触部に当接するステップと、
前記シャフト部により前記破砕部の遠位側の端部および近位側の端部を同時に回転させて前記物体に接触させて当該物体を破砕するステップと、を有する処置方法。
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