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WO2018221462A1 - Dispositif et méthode d'athérectomie - Google Patents

Dispositif et méthode d'athérectomie Download PDF

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Publication number
WO2018221462A1
WO2018221462A1 PCT/JP2018/020381 JP2018020381W WO2018221462A1 WO 2018221462 A1 WO2018221462 A1 WO 2018221462A1 JP 2018020381 W JP2018020381 W JP 2018020381W WO 2018221462 A1 WO2018221462 A1 WO 2018221462A1
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WO
WIPO (PCT)
Prior art keywords
tubular member
medical device
bendable
outer tubular
exemplary embodiment
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/JP2018/020381
Other languages
English (en)
Inventor
Tomonori Hatta
Kosuke Nishio
Taiga Nakano
Junichi Kobayashi
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.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Publication of WO2018221462A1 publication Critical patent/WO2018221462A1/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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00305—Constructional details of the flexible means
    • A61B2017/00309—Cut-outs or slits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • A61B2017/00327—Cables or rods with actuating members moving in opposite directions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00331—Steering mechanisms with preformed bends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00738—Aspects not otherwise provided for part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2901—Details of shaft
    • A61B2017/2905—Details of shaft flexible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the present invention generally relates to atherectomy devices and methods for removing substances from a living body. More specifically, the present invention involves positioning a rotatable treatment member in a living body with a pre-bent portion or manually bendable portion and grinding the substance in the living body through rotation of the treatment member.
  • Medical devices are used to remove substances from a living body.
  • an atherectomy device is used to remove arteriosclerosis from a blood vessel.
  • the atherectomy device is typically configured to be positioned in the living body adjacent the substance to be cut and then the treatment part of the device is then rotated to cut the substance.
  • the debris resulting from this cutting procedure is then removed from the living body.
  • the removal of the cut-away debris can be accomplished by way of a gateway lumen passing through the atherectomy device.
  • Proposals have been made to address concerns about distal embolization.
  • some atherectomy devices are provided with an aspiration function for removing the debris by way of an aspiration port.
  • these solutions have not been found to be particularly satisfactory.
  • choking of the aspiration port occurs, thus inhibiting or preventing a continuous aspiration of the desired region.
  • the atherectomy procedure for cutting substance from a living body lumen typically involves the use of two different guidewires.
  • a first coated guidewire is used to deliver the atherectomy device to the stenotic region or treatment area. After the atherectomy device is located at the desired position, the coated guidewire is removed and a second different guidewire is inserted into the atherectomy device.
  • One way in which the second guidewire differs from the first is that the second guidewire is not coated. This second non-coated guidewire is used during operation of the atherectomy device when the treatment part is rotated at a high speed.
  • the coated first guidewire is a preferred guidewire for guiding and delivering the atherectomy device to the treatment area.
  • the coating on this first guidewire tends to become abraded or damaged during rotation of the treatment part.
  • the abrasion of the rotating treatment part against the coated guidewire can produce coating fragments that may cause distal embolization.
  • a medical device comprising: an inner member, the inner member comprises a bendable part and a transmission part; an operation member; and an outer tubular member, wherein the bendable part is fixed to both the outer tubular member and the operation member, and the operation member is configured to move axially relative to the outer tubular member.
  • a method comprising: introducing a treatment member on a distal end portion of an inner member, the inner member comprises a bendable part and a transmission part, an operation member; and an outer tubular member, wherein the bendable part is fixed to both the outer tubular member and the operation member, and the operation member is configured to move axially relative to the outer tubular member; bending the inner member and the outer tubular member to one direction while moving the operation member of the inner tubular member to the axial direction; rotating the treatment member in the bending state while the treatment member is positioned adjacent to the substance to be cut in the living body to cut the substance; and shearing debris resulting from the cutting of the substance to reduce a size of the debris.
  • FIG. 1 is a schematic view of the medical device according to one embodiment.
  • FIGS. 2A and 2B are cross-sectional views of the distal portion of the medical device, including the treatment member having a pre-bending portion or manual bending portion, positioned in a blood vessel to cut-away or grind-away a substance in the blood vessel.
  • FIG. 3 is a perspective view of one version of the treatment member forming part of the medical device shown in FIG. 1.
  • FIG. 4 is a cross-sectional view of the treatment member illustrated in FIG. 3.
  • FIG. 5A is an illustration of a medical device having an outer tubular member in accordance with an exemplary embodiment.
  • FIG. 5B is an end view of the medical device having the outer tubular member as shown in FIG. 5A in accordance with an exemplary embodiment.
  • FIG. 6 is an illustration of a medical device having an outer tubular member in accordance with an exemplary embodiment.
  • FIG. 7A is an illustration of a first tubular member of the outer tubular member in accordance with an exemplary embodiment.
  • FIG. 7B is an illustration of a second tubular member of the outer tubular member in accordance with an exemplary embodiment.
  • FIG. 8A is an illustration of the medical device having an outer tubular member in accordance with an exemplary embodiment.
  • FIG. 8B is a cross-sectional view of the connection portion as shown in FIG. 8A in accordance with an exemplary embodiment.
  • FIG. 9A is an illustration of another exemplary embodiment of a medical device having a helical outer tubular member in accordance with an exemplary embodiment.
  • FIG. 9B is an end view of the helical outer tubular member as shown in FIG. 9A in accordance with an exemplary embodiment.
  • FIG. 10 is an illustration of a medical device having a manual bending portion in accordance with another exemplary embodiment.
  • FIG. 11A is an illustration of a medical device having a manual bending portion in accordance with another exemplary embodiment.
  • FIG. 11B is an illustration of a medical device having a manual bending member in accordance with another exemplary embodiment.
  • FIG. 11C is an illustration of a medical device having a manual bending member in accordance with another exemplary embodiment.
  • FIGS. 12A-12C are illustrations of a plurality of vertical section views of the manual bending member in accordance with an exemplary embodiment.
  • FIG. 13A is an illustration of a portion of a medical device having a manual bending member in accordance with another exemplary embodiment.
  • FIG. 13B is an illustration of a portion of a medical device having a manual bending member in accordance with another exemplary embodiment.
  • FIG. 13C is an illustration of a portion of a medical device having a manual bending member in accordance with another exemplary embodiment.
  • FIG. 1 schematically illustrates one embodiment of the medical device representing an example of the inventive medical device disclosed here.
  • This disclosed medical device is configured to grind a substance in a body lumen such as arteriosclerosis in a blood vessel.
  • the terms “cut” and “cutting” as used here are not limited to any particular operation or manner of acting on the substance, and include operations such as cutting, scraping, abrading, ablating, macerating, grinding and otherwise breaking down desired substance or material into particles or other smaller units of material to facilitate removal from the living body (e.g., blood vessel).
  • the medical device 100 shown in FIG. 1 can be used to grind a stenosis 30 such as shown in FIGS. 2A, 2B from a blood vessel 10, which stenosis can be constituted by a thrombus, calcified lesion, etc.
  • the medical device 100 may include a treatment member 102 and an operation unit 104 configured to transmit a rotation driving force to the treatment member 102 to rotate the treatment member 102.
  • the operation unit 104 may be housed in a handle 108.
  • the operation unit 104 includes a motor 28 that produces a rotational output force.
  • the operation unit 104 also includes a drive mechanism section 122 for transmitting or applying the rotational output shaft of the motor 28 to the drive shaft 114.
  • the drive mechanism section 122 includes a drive gear 124 and a driven gear 120 that mesh with one another so that rotation of the drive gear 124 results in rotation of the driven gear 120.
  • the motor 128 serves as a driving source and includes a rotatable motor shaft 130 to which the drive gear 124 is fixed so that the motor shaft 130 and the drive gear 124 rotate together as a unit. Operation of the motor 128 causes rotation of the motor shaft 130 which in turn results in rotation of the drive gear 124.
  • the proximal end of the drive shaft 114 may be fixed to the driven gear 120 so that the drive shaft 114 and the driven gear 120 rotate together as a unit.
  • a power supply section 106 that includes a battery 126 may be provided in the handle 108 and connected to the motor 128 to supply power to the motor 128.
  • a power cable 110 may be connected to the battery 126 to supply power.
  • FIG. 1 also shows that the medical device 100 may be provided with an aspiration tube 112 to remove (i.e., draw-away or suck-away) debris resulting the grinding of the substance 30.
  • the drive shaft 114 may be comprised of a tubular drive shaft that is hollow so that a central lumen extends throughout the entire axial extent of the drive shaft 114.
  • the drive shaft 114 may preferably be flexible, but also well suited to transmitting the rotational output of the motor unit from the proximal end of the drive shaft 114 to the distal end of the drive shaft 114 at which the treatment member 102 is located.
  • the drive shaft 114 may be any desired construction.
  • the drive shaft 114 may be constituted by a multi-layer structure.
  • the drive shaft 114 may be configured as a multi-layered coiled tube made from, for example, a polyolefin such as polyethylene or polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluorine series such as PTFE Polymer, PEEK, polyimide, or combinations thereof.
  • the tubular drive shaft can also be provided with reinforcement.
  • the size of the drive shaft may be appropriately selected. Examples of an appropriate size include an inner diameter of 0.40 mm - 1.40 mm and an outer diameter of 0.6 mm – 1.6 mm.
  • the drive shaft 114 is preferably a tubular drive shaft as mentioned above so that the drive shaft includes a lumen defining a guidewire-receiving passage.
  • the guidewire passes through the lumen in the drive shaft and allows the drive shaft 114 together with the treatment member 102 to be navigated through the living body (e.g., the lumen of a blood vessel) to position the treatment member 102 at the desired place adjacent substance to be ground.
  • the drive shaft 114 may be housed in a tubular outer sheath 116.
  • the outer sheath 116 may be a tubular body that accommodates the drive shaft 114 so that the drive shaft 114 is rotatable and axially movable relative to the outer sheath 116 and in the outer sheath 116.
  • the material forming the outer sheath 116 is not limited to a particular material.
  • the outer sheath 116 may be made of polyethylene, polypropylene, polyolefin such as polyethylene terephthalate, polyester such as polyamide terephthalate, fluorine-based polymers such as PTFE, PEEK, polyimide and the like.
  • the operation of the motor 128 can be controlled by way of a switch 132. Operating or turning on the switch 132 causes the motor 128 to operate and rotate the motor shaft 130. As a result, the drive gear 124 rotates and in turn rotates the driven gear 120 which meshes with the drive gear 124. The rotation of the driven gear 120 results in rotation of the drive shaft 114 and ultimately rotation of the treatment member 102.
  • FIGS. 2A and 2B shows a state of grinding a stenosis 30 in a blood vessel 10 using the medical device 100 according to this embodiment.
  • FIGS. 2A and 2B when grinding the structure 30 on a vessel wall 20 of the blood vessel 10.
  • the rolling structure 110 rotates and the third grinding part 118 and the first grinding part 123 rotate the inside of the living body lumen of the stenosis 30 can be ground.
  • the diameter of the bottom portion 127 of the constricted portion 126 becomes the first diameter.
  • the diameter of the annular portion 112 (see FIG. 3), and the diameter of the second annular portion 111 it is possible to prevent the first grinding part 123 from coming into contact with the living tissue such as a normal blood vessel, and relatively high safety can be secured.
  • the bending section 118 may be provided in the tubular outer sheath 116 and the drive shaft 114. This bending section 118 may be provided at an intermediate point along the length of the drive shaft 114 and the outer sheath 116. In this bending section 118, the outer sheath 116 and the drive shaft 114 are bent such as illustrated in FIGS. 2A, 2B. This allows the treatment unit 102 to be manipulated in a way that allows grinding of the stenosis 30 located in a blood vessel 20. That is, as the drive shaft 114 is rotated by operation of the motor 128, the treatment member 102 traces a movement path this circular or annular, as opposed to rotating about the central axis of the drive shaft 114.
  • FIGS. 2A and 2B also illustrate that, during operation of the medical device while the treatment member 102 is positioned in the living body (blood vessel) and is being rotated, the distal end portion of the treatment member 102 is positioned distally beyond the distal-most end of the outer sheath 116.
  • FIGS. 3 and 4 illustrate additional details associated with the treatment member 102 that is connected to the distal end of the drive shaft 114.
  • FIGS. 3 and 4 illustrate the centrally located guidewire lumen 115 that may be centrally provided in the drive shaft 114 for receiving a guidewire as discussed above.
  • the distal end portion of the treatment member 102 is positioned distally beyond the distal-most end of the outer sheath 116.
  • FIGS. 3 and 4 show that the treatment member 102 that extends distally beyond the distal-most end of the tubular outer sheath 116 and is thus exposed (for example, the treatment member 102 not covered by the outer sheath 116).
  • the treatment member 102 that is exposed distally beyond the distal end of the outer sheath 116 during operation may be comprised of a distal-most end portion 136, an intermediate portion 138 and a proximal end portion 140.
  • the intermediate portion 138 is positioned axially between the distal-most end portion 136 and the proximal end portion 140.
  • the distal-most end portion 136, the intermediate portion 138 and the proximal end portion 140 may preferably be configured to facilitate grinding of the substance in the body lumen (e.g., stenosis S in a blood vessel BV).
  • One way of accomplishing this result is to provide the distal-most end portion 136, the intermediate portion 138 and the proximal end portion 140 of the treatment member 102 with a coating that helps facilitate the grinding of the substance in the body lumen.
  • a coating is a diamond grind coating.
  • the distal-most end portion 136 of the treatment member 102 is comprised of a distally tapering portion 142 and a proximally tapering portion 144.
  • the proximally tapering portion 144 is positioned proximal of the distally tapering portion 142.
  • the distally tapering portion 142 constantly tapers in a narrowing manner towards the distal-most end of the treatment member 102 while the proximally tapering portion 144 constantly tapers in a narrowing manner towards the proximal-most end of the treatment member 102.
  • the distal-most end portion 136 of the treatment member 102 also comprises a constant outer diameter intermediate portion 143 positioned between the distally tapering portion 142 and the proximally tapering portion 144.
  • the coating that helps facilitate the grinding of the substance in the body lumen is not provided on the constant outer diameter intermediate portion 143.
  • the coating applied to the outer surface of the remainder of the treatment member 102 may also be provided on the outer surface of the constant outer diameter intermediate portion 143.
  • the intermediate portion 138 may be a tapering portion as illustrated in FIGS. 3 and 4 in which the intermediate portion tapers in a constant manner along its entire extent from the proximal-most end of the intermediate portion 138 to the distal-most end of the intermediate portion 138.
  • the intermediate portion 138 tapers towards the distal-most end of the treatment member 102 so that the outer diameter of the intermediate portion 138 gradually narrows in the distal direction.
  • the proximal end portion 140 may possess a constant outer diameter along its entire axial extent as shown in FIGS. 3 and 4.
  • the treatment member 102 is also provided with at least one window or through opening 150 that communicates with the hollow interior or lumen inside the treatment member 102.
  • the treatment member 102 may include a plurality of circumferentially spaced-apart windows or through openings 150. As mentioned above, each of the windows or through openings 150 opens into and communicates with the hollow interior or lumen (gateway lumen) in the treatment member 102.
  • the lumen or hollow interior of the treatment member 102 is in communication with the lumen 117 in the outer sheath 116 as shown in FIG. 4.
  • the aspiration tube 112 shown in FIG. 1 is connected to or fluidly communicates with the lumen 117 in the outer sheath 116.
  • the aspiration tube 112 is connected to an aspiration source or suction device 111 schematically illustrated in FIG. 1.
  • the treatment member 102 is rotated by operation of the motor 128 to grind the substance 30 in the body lumen 10 (e.g., stenosis in the blood vessel). While the treatment member 102 is grinding the substance in the body lumen, the suction source 111 is operated to draw debris resulting from the grinding operation through the windows or through openings 150 in the treatment member 102, into the lumen or hollow interior in the treatment member 102, and into the lumen 117 in the outer sheath 116. The debris is then drawn out of or removed from the body lumen by way of the suction device 111.
  • the suction source 111 is operated to draw debris resulting from the grinding operation through the windows or through openings 150 in the treatment member 102, into the lumen or hollow interior in the treatment member 102, and into the lumen 117 in the outer sheath 116. The debris is then drawn out of or removed from the body lumen by way of the suction device 111.
  • the proximal end portion of the treatment member 102 includes a reduced outer diameter portion defining a shaft portion 152 of the treatment member 102.
  • This reduced-outer diameter shaft portion 152 of the treatment member 102 represents a seating region for receiving an outer tubular member 160 representing a shaft bearing or bush member.
  • a lumen extends throughout the entire axial extent of the outer tubular member 160 (i.e., passes through the outer tubular member 160), and the reduced-outer diameter shaft portion 152 of the treatment member is positioned in the lumen that extends throughout the entire axial extent of the outer tubular member 160.
  • the tubular member 160 is rotatable relative to the treatment member 102. That is, as described above, the treatment member 102 is rotatably driven by way of the drive shaft 114, and the treatment member 102 rotates relative to the tubular member 160.
  • An axially extending lumen extends throughout the entire length of the reduced-outer diameter shaft portion 152 (for example, passes through the reduced-outer diameter shaft portion 152).
  • This lumen in the reduced-outer diameter shaft portion 152 communicates with and is coaxial with the lumen 115 in the drive shaft 114.
  • the lumen in the reduced-outer diameter shaft portion 152 is also coaxial with the open end 119 at the distal-most end of the treatment member 102 shown in FIG. 3 and opens into and communicates with the lumen in the treatment member 102.
  • a bearing may be positioned between the outer surface of the reduced outer diameter shaft portion 152 and the inner surface of the outer tubular member 160 to facilitate the relative rotation between the reduced outer diameter shaft portion 152 and the outer tubular member 160.
  • the bearing may be of any desired configuration, including a plurality of roller bearings 162 as shown in FIG. 4. The roller bearings 162 help facilitate relative rotation between the treatment member 102 and the outer tubular member 160.
  • the outer peripheral surface of the outer tubular member 160 may be recessed to define a radially inwardly recessed portion defining a recess 164.
  • the recess 164 is of limited circumferential extent (i.e., the recess 164 does not extend around the entire circumferential extent of the outer tubular member 160) so that the recess 164 possesses a circumferential extent less than 360º, preferably less than 180º.
  • the recess 164 extends from the proximal-most end of the outer tubular member 160 towards the distal end of the outer tubular member 160.
  • the recess 164 thus opens to the proximal-most end of the outer tubular member 160 and extends less than the entire axial extend of the outer tubular member 160 so that the distal-most end of the recess 164 is defined by a wall 166.
  • FIG. 4 illustrates that the recess 164 in the outer surface of the outer tubular member 160 receives a distally extending projection at the distal end portion of the outer sheath 116.
  • the engagement between the distally extending projection 168 of the outer sheath 116 and the recess 166 in the outer tubular member 160 rotationally fixes the outer sheath 116 and the outer tubular member 160 so that the outer sheath 116 and the outer tubular member 160 do not rotate relative to each other.
  • the outer tubular member 160 may also include at least one radially inwardly directed protrusion 170.
  • FIG. 5A is an illustration of a medical device 100 having an outer tubular member 400 in accordance with an exemplary embodiment.
  • the outer tubular member 400 includes a first tubular member 410 and a second tubular member 420.
  • a connection 450 connects the first tubular member 410 to the second tubular member 420.
  • the outer tubular member 400 which is adjacent to the treatment member 102 includes a first bend (or first bend element) 430 and a second bend (or second bend element) 440.
  • the outer tubular member 400 is configured to be placed around the drive shaft 114 and inside the outer sheath 116, and is arranged on the distal end of the drive shaft 114 and the outer sheath 116 adjacent to the treatment member 102 (not shown in FIGS. 5A or 5B).
  • FIG. 5B is an end view of the medical device 10 having the outer tubular member pre-bending portion 400 as shown in FIG. 5A in accordance with an exemplary embodiment.
  • the second tubular member 420 preferably in contact with the vessel wall 20 on one side and the first tubular member 410 is in contact with the vessel wall 20 on an opposite side, for example, 180 degrees to one another.
  • FIG. 6 is an illustration of a medical device 100 having an outer tubular member 400 in accordance with an exemplary embodiment.
  • the outer tubular member 400 of the device 100 in a natural state (for example, a packaged state), has a least one first bend element 430 including a distal end portion of the outer tubular element and a second bend element 440 proximal to the first bend element 430.
  • the at least the first bend element 430 and the second bend element 440 can contact a vessel wall at the same time.
  • the first bend element 430 is configured to redirect a tip 103 of treatment member 102 in order not to face the tip 103 toward a vessel wall 20 during use for safety.
  • the second bend element 440 is configured to enhance a contact force against the vessel wall 20.
  • an outer diameter of the outer tubular member 400 is preferably less than or equal to an outer diameter of the treatment member 102. In accordance with an exemplary embodiment, there is a possibility that it cannot penetrate the vessel wall, if the outer diameter of the outer tubular member 400 is larger than that of the treatment member 102.
  • the first bend element 430 and the treatment member 102 are substantially coplanar in state of contact with the vessel wall 20, which helps the treatment member 102 to safely contact the vessel wall 20.
  • the outer diameter of the treatment member 102 is larger than the outer diameter of the outer tubular member 400.
  • the difference between the outer diameters of the treatment member 102 and the outer tubular member 400 is smaller than the blood vessel wall 20. This helps prevent perforation of the vessel wall 20 if the treatment member 102 is inserted into a vessel lumen which has a smaller inner diameter than the outer diameter of the treatment member 102.
  • the treatment member can be rotated while the treatment member is positioned adjacent to the substance to be ground in the living body and grinding the substance without withdrawing a coated wire or coated guidewire.
  • the coated wire or coated guidewire has a coating, which is hydrophobic to improve the capacity of the sliding of the coated wire or guidewire in the vessel.
  • d is an outer diameter of first tubular member 410
  • h is an inner diameter of a target blood vessel lumen
  • ⁇ 1 is an angle (R1) in degrees of the first bend element 430
  • ⁇ 2 is an angle (R2) in degrees of the second bend element 440
  • l is a length between the first bend element 430 and the second bend element 440.
  • R1 is preferably equal to R2.
  • R1 is preferably equal to R2.
  • R1 is preferably equal to R2.
  • the outer tubular member 400 is preferably composed of one or more rigid materials.
  • the one or more rigid materials can be one or more materials, which can maintain a natural state, and be difficult to change a straight line, and wherein the natural state is a state in which, for example the outer tubular member 400 in not limited (or constrained) by something, for example, a vessel wall.
  • the outer tubular member 400 is comprised of the first tubular member 410, which is preferably Nitinol, and the second tubular member 420 is preferably, for example, stainless steel (SUS), and the connecting part (or connector) 450.
  • SUS stainless steel
  • a shape memory alloy as the material of the bend member, it is possible to obtain a predetermined shape, elastic force (contact force) against a blood vessel by its characteristic.
  • a shape memory alloy As the material of the bend member, it is possible to obtain a predetermined shape, elastic force (contact force) against a blood vessel by its characteristic.
  • the shape In case of stainless steel (SUS), the shape can be changed from the original shape during the procedure.
  • rigidity of a distal end 412 of the first tubular member 410 is higher than one of the first bend element 430. Since the distal end of the treatment member is linearly aligned with the first tubular member 410, the surface of the treatment member is likely to contact a blood vessel wall or the lesion. As shown in FIG. 6, the first bend element 430 and the second bend element 440 are located in the first tubular member 410. In accordance with an exemplary embodiment, the connection part (or connector) 450 is located on the straight part of the outer tubular member 400, which can efficiently transmit the pushability transmitted by the second tubular member 420 to the first tubular member 410.
  • the first bend element 430, the second bend element 440, and the treatment member 102 helically contact in a blood vessel wall 20.
  • the treatment member 102 can advance helically and can remove vascular occlusion material in the circumferential direction.
  • the outer tubular member 400 can rotate while maintaining the state in which a guide wire does not rotate with the first bend element 430, while the first bend element 430 and treatment member 102 in state of contact with a vessel wall 20, which helps prevent damage to a guide wire
  • FIG. 7A is an illustration of a first tubular member 410 of the outer tubular member 400 in accordance with an exemplary embodiment.
  • the first tubular member 410 is preferably a shaped memory alloy, for example, a Nitinol tube with laser cutting.
  • FIG. 7B is an illustration of a second tubular member 420 of the outer tubular member 400 in accordance with an exemplary embodiment.
  • the second tubular member 420 is configured to transmit torque to the first tubular member 410 and the treatment member 102 and is preferably a stainless tube with laser cutting or a braided tube.
  • FIG. 8A is an illustration of the medical device 100 having an outer tubular member 400 and the connection portion 450 in accordance with an exemplary embodiment.
  • FIG. 8B is a cross-sectional view of the connection portion 450 as shown in FIG. 8A in accordance with an exemplary embodiment.
  • the connection portion 450 includes a plurality of holes 510 on the first tubular member 410 and a plurality of holes 520 on the second tubular member 420 and a joint member 530, which solder is placed into the plurality of holes 510, 520 to connect the first tubular member 410 to the second tubular member 420.
  • the joint member 530 is a stainless steel tube.
  • the plurality of holes 510, 520 extend through an outer circumference of each of the first and the second tubular members 410, 420.
  • the number of holes 510, 520 is at least two (2) and can be, for example, two (2) to eight (8), and more preferably two (2) to four (4) holes.
  • FIG. 9A is an illustration of another exemplary embodiment of a medical device 100 having an outer tubular member 400.
  • FIG. 9B is an end view of the medical device 100 having a pre-bending portion of the outer tubular member 400 as shown in FIG. 9A in accordance with an exemplary embodiment.
  • the first and the second tubular elements 410, 420 can be configured to have a helical (or spiral) configuration 600.
  • FIG. 10 is an illustration of a medical device 100 having a manual bending member 700 in accordance with another exemplary embodiment.
  • the manual bending member 700 can be bent by pushing or pulling an operation member 770.
  • the curvature of the manual bending member increases.
  • the curvature of the manual member decreases (i.e., becomes relatively flat or straight).
  • a method which includes introducing a treatment member on a distal end portion of a inner member, the inner member comprises a bendable part and a transmission part, an operation member; and an outer tubular member, wherein the bendable part is fixed to both the outer tubular member and the operation member, and the operation member is configured to move axially relative to the outer tubular member.
  • the inner member and the outer tubular member can be bent to one direction while moving the operation member of the inner tubular member to the axial direction.
  • the treatment member is rotated in the bending state while the treatment member is positioned adjacent to the substance to be ground in the living body to grind the substance, and shearing debris resulting from the grinding of the substance to reduce a size of the debris.
  • a second bending the inner member and the outer tubular member to other directions while moving the operation member of the inner tubular member to an opposite axial direction.
  • FIG. 11A is an illustration of a medical device 100 having a manual bending member 700 in accordance with another exemplary embodiment.
  • the manual bending member 700 can be arranged within an outer housing (or outer layer) 720 and can include an inner member 710 and an operation member 770.
  • the inner member 710 comprises at least a bendable part 730 configured of a plural members 732, 734.
  • the inner member 710 may have a transmission part 740.
  • the transmission part 740 is preferably a tubular member (i.e., an inner tubular member) 750.
  • the bendable part 730 is fixed to a proximal end 776, 778 of the transmission part 740 and is fixed to a distal portion 774 of the outer tubular member 780and a distal end 772 of the operation member 770.
  • the operation member 770 is axially movable relative to the outer tubular member 780.
  • the transmission part 740 may be the same as the bendable part 730.
  • the transmission part 740 may be a rigid member that is more rigid than the bendable part of the inner member 710.
  • the rigid member can easily transmit the force received from the operation member.
  • the rigid member of the inner member 710 is more rigid than the bendable part 730 of the inner member 710.
  • the outer tubular member 780 in which the bendable part 730 of the inner member 710 is located is flexible.
  • the outer tubular member 780 comprises at least two parts, a rigid member or rigid part of the outer tubular member 780, and a flexible member 730 of the outer tubular member 780.
  • the flexible members 782 of the outer tubular member 780 is located in an outwardly radial direction of the bendable part 730 of the inner member 710.
  • the outer tubular member 780 may comprise only flexible part that can bend with the bendable part 730 of the inner member 710.
  • the flexible member 782 is more flexible than the transmission part 740 that can bend.
  • the bendable parts 730 are each disposed at 180 degrees to one another.
  • the bendable part 730 can be arranged in diagonal positions to one another in the circumferential direction and axially movable relative to one another.
  • the transmission part 740 of the inner member 710 can be fixed to the bendable part 730 of the inner member 710 by a joint part (or connection joint) 790, which can help preset an optimal contact force in the blood vessel for example, for safety.
  • the rigid part 740 of the inner member 710 is more rigid than the bendable part 730 of the inner member 710.
  • the rigid part 740 of the inner member 710 can have a pre-shaped part (or member) 760, which can also help preset an optimal contact force in the blood vessel for safety.
  • the pre-shaped part (or member) 760 can have a defined curvature or an angle between a distal side 762 and a proximal side 764.
  • a portion of the outer tubular member 780 in which the rigid member 740 of the inner member 740 can be flexible. The flexible member of the inner member 740 is more flexible than the rigid member of the inner member 740.
  • the outer tubular member 780 can terminate proximally of the joint part (connection joint) 790.
  • an outer diameter of the distal side of the medical device 100 can be relatively smaller than with the outer tubular member 780 extending to the treatment member 102.
  • the bendable part 730 can be adapted to preferentially bend in one direction, which can help reduce the required tensile force required for bending.
  • the operation member 770 can be a tubular member, which can help resolve the issues, for example, wherein a wire is pulled, and wherein the bending of the outer tubular member 780 affects the bending to the bendable part 730.
  • the length of each of the bendable members 732, 734 is different such that the manually bending member 700 can be bent bi-directionally.
  • a long bendable member of the at least two bendable members having different lengths is fixed to the outer tubular member and a short bendable member of the at least two bendable members is fixed to the operation member.
  • the operation member 770 can be a wire.
  • the transmission part 740 of the inner member 710 is a tubular member or a flat member. As shown, the bendable part 730 of the inner member 710 is a plural number.
  • the material of the inner tubular member 750 is different from the material of the operation member 770. For example, it is possible to set different rigidity, elasticity only at the inner tubular member 750, for example, for enhancing contact force against a vessel wall 20.
  • FIG. 11C is an illustration of a medical device having a manual bending member 700 in accordance with another exemplary embodiment.
  • the manual bending member 700 has a joint member 790 configured to connect the inner tubular member 750 and the operation member 770.
  • the position of the distal end face 776 of the operation member 770 is different in the axial direction for connecting the inner tubular member to the operation member than a non-connecting distal end face of the operation member.
  • the difference of the distal end face 776 of the operation member which can help maintain the inner lumen.
  • the inner tubular member 750 can be soldered though at least one hole 775, 777 in the inner tubular member 750 and the operation member 770, for example, to a plate 792, which joins the distal end 776 of the operation member 780.
  • the inner tubular member 750 can be soldered through at least one hole 779 to a second plate 794, which joins a proximal end of the inner tubular member 750 to the outer tubular member 780.
  • an outer layer 720 on an outer surface of the outer tubular member 780 can be used to help seal for suction or flushing of fluid and/or debris during use.
  • an inner layer (not shown) on the surface of the inner tubular member 750 can be used to seal for suction or flushing of fluid and/or debris during use.
  • the outer layer 720 and/or inner layer of the inner tubular member 750 can be, for example, PTFE polymer or a shrink-wrap material, which seals an outer surface and/or an inner surface of the inner tubular member 750
  • FIGS. 12A-12C are illustrations of a plurality of vertical section views of the manual bending member 700 in accordance with an exemplary embodiment. As shown in FIGS. 12A-12C, the bendable part 730 of the inner member 710 is a plural number.
  • the outer tubular member 780 in which the bendable part 730 of the inner member 710 is located is flexible, and the bendable parts 730 are each disposed at 180 degrees to one another.
  • the bendable members 732, 734 can be arranged in substantially diagonal positions to one another in the circumferential direction.
  • the bendable member 732, 734 are configured to be axially movable relative to one another.
  • the bendable parts can be arranged to have one bendable member 732 fixed to the operation member 770 and two bendable members 734 fixed to the outer tubular member 780.
  • the bendable members 732, 734 can be arranged at an equal positions to one another in the circumferential direction from each other, for example, at 120 degrees, or alternatively, the two bendable members 734 can be arranged at an equal circumferential position from an opposing bendable member 732 arranged at 180 degrees to a center point between the two bendable members 734.
  • the bendable part 730 can include at least two bendable members 732 connected to the operation member 780 and at least two bendable members 734 connected to the outer member 780.
  • the bendable parts 732, 734 are preferably arranged at equal positions in the circumferential direction and are axially movable relative to one another.
  • FIG. 13A is an illustration of a portion of a medical device 100 having a manual bending member 700 in accordance with another exemplary embodiment.
  • the first inner tubular member 750 can be a shape memory allow, for example, Nitinol with laser cutting.
  • the first inner tubular member 750 may be a plastic.
  • the first inner tubular member 750 has a relatively flat cross-sectional shape.
  • FIG. 13B is an illustration of a portion of a medical device 100 having a manual bending member 700 in accordance with another exemplary embodiment.
  • the operation member 770 can be a tubular member 772 having a low elongation rate and is flexible.
  • the operation member 770 is a stainless steel tube with laser cutting or a braided tube.
  • FIG. 13C is an illustration of a portion of a medical device 100 having a manual bending member 700 in accordance with another exemplary embodiment.
  • the outer tubular member 780 preferably has high torque response with a low elongation rate, a low compression rate, and is flexible on the bendable part 730.
  • the outer tubular member 780 is a stainless steel tube with laser cutting or a braided tube.
  • the living body lumen into which the medical device is inserted is not limited to a blood vessel, for example, it may be a vessel, ureter, bile duct, oviduct, hepatic duct and the like.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif médical (100) comprenant : un élément interne (710) comprenant une partie pliable (730) et une partie de transmission (740) ; un élément d'actionnement (770) ; et un élément tubulaire externe (780), la partie pliable (730) étant fixée à la fois sur l'élément tubulaire externe (780) et sur l'élément d'actionnement (770), ce dernier (770) étant conçu pour se déplacer axialement par rapport à l'élément tubulaire externe (780).
PCT/JP2018/020381 2017-05-30 2018-05-28 Dispositif et méthode d'athérectomie Ceased WO2018221462A1 (fr)

Applications Claiming Priority (2)

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US201762512509P 2017-05-30 2017-05-30
US62/512,509 2017-05-30

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WO2018221462A1 true WO2018221462A1 (fr) 2018-12-06

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5851212A (en) * 1997-06-11 1998-12-22 Endius Incorporated Surgical instrument
US20110264113A1 (en) * 2008-12-12 2011-10-27 Seung Wook Choi Surgical instrument
US20110319905A1 (en) * 2010-06-23 2011-12-29 Palme Robert A Multiple function vascular device
US20120265176A1 (en) * 2010-04-14 2012-10-18 Tuebingen Scientific Medical Gmbh Surgical instrument with elastically movable instrument head
US20130317520A1 (en) * 2012-05-25 2013-11-28 Samsung Electronics Co., Ltd. Surgical implement and manipulation system including the same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5851212A (en) * 1997-06-11 1998-12-22 Endius Incorporated Surgical instrument
US20110264113A1 (en) * 2008-12-12 2011-10-27 Seung Wook Choi Surgical instrument
US20120265176A1 (en) * 2010-04-14 2012-10-18 Tuebingen Scientific Medical Gmbh Surgical instrument with elastically movable instrument head
US20110319905A1 (en) * 2010-06-23 2011-12-29 Palme Robert A Multiple function vascular device
US20130317520A1 (en) * 2012-05-25 2013-11-28 Samsung Electronics Co., Ltd. Surgical implement and manipulation system including the same

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