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WO2014045403A1 - Système de délivrance - Google Patents

Système de délivrance Download PDF

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Publication number
WO2014045403A1
WO2014045403A1 PCT/JP2012/074225 JP2012074225W WO2014045403A1 WO 2014045403 A1 WO2014045403 A1 WO 2014045403A1 JP 2012074225 W JP2012074225 W JP 2012074225W WO 2014045403 A1 WO2014045403 A1 WO 2014045403A1
Authority
WO
WIPO (PCT)
Prior art keywords
delivery system
implant
shaft
stent graft
end side
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/JP2012/074225
Other languages
English (en)
Japanese (ja)
Inventor
澤田明
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
Priority to PCT/JP2012/074225 priority Critical patent/WO2014045403A1/fr
Publication of WO2014045403A1 publication Critical patent/WO2014045403A1/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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2/9661—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod the proximal portion of the stent or stent-graft is released first

Definitions

  • the present invention relates to a delivery system for delivering an artificial implant into a living body lumen such as a blood vessel. More specifically, the angle of a predetermined part of the implant with respect to the living body lumen is adjusted by an intuitive operation. It relates to a delivery system that can be used.
  • a general stent graft is formed by forming a wire such as nickel titanium alloy or stainless steel in a Z shape or a ring shape on the inner surface or outer surface of a graft made of a woven fabric (fabric) woven with resin yarn such as polyester.
  • the skeleton (stent) is configured by being sutured and fixed, and is placed in a desired blood vessel or the like by being expanded and deployed in a body cavity.
  • a stent graft delivery system for delivering and placing a stent graft to a target position in a body cavity includes a long shaft, a sheath that is axially displaceable along the shaft, and a tip of the shaft as main components. And a stent graft placed in a folded state on the inside of the sheath.
  • the stent graft procedure if the stent graft is placed in a state where it is tilted with respect to the axis of the blood vessel, a blood flow leak or the like may occur. Therefore, it is important to arrange the stent graft in a state in which the distal end opening (inlet end portion) of the stent graft is perpendicular to the axis of the blood vessel. Further, in the stent graft procedure, it may be necessary to accurately position the indwelling position so that the stent graft does not cover the branch vessel that is not desired to be blocked.
  • the present invention has been made in consideration of such problems, and an object of the present invention is to provide a delivery system capable of easily adjusting the angle of a predetermined site of an implant with respect to a living body lumen.
  • a delivery system includes an implant configured to be placed in a living body lumen, and the implant is placed on a distal end side and can be inserted into the living body lumen.
  • a delivery device wherein the delivery device is provided on the base end side of the shaft and is operable to swing in at least two different directions with respect to the axial direction of the shaft;
  • a transmission mechanism disposed along the shaft, connected to the operation unit and a control target site of the implant, and transmitting a driving force input to the operation unit to the implant;
  • the part to be controlled of the implant is operated under the action of the transmission mechanism by swinging the part.
  • the control target part of the implant when the operation unit provided on the hand side is operated, the control target part of the implant can be operated. Therefore, when the operator adjusts the angle of the control target portion with respect to the blood vessel axis, it is only necessary to lift the operation portion on the hand side, and the operation is easy.
  • the operating portion can be swung in at least two different directions with respect to the shaft, the implant can be tilted in at least two directions, and the angle of the control target portion of the implant in vivo can be adjusted. Therefore, the implant can be positioned with high accuracy.
  • the transmission mechanism includes a plurality of flexible linear members having at least a part of the extending direction inserted into the shaft, and the shaft is moved along with the swing of the operation unit.
  • the control target portion of the implant may operate in synchronization with the operation unit.
  • the flexible linear member is used as the transmission mechanism, the operation followability of the control target part with respect to the movement of the operation unit is good, and the operability is excellent.
  • the plurality of linear members are fixed to the operation unit at different positions in the circumferential direction and connected to the control target site at different positions in the circumferential direction. Accordingly, a plurality of first elements that are pulled at least partially so as to displace the control target part in the proximal direction, and the control at positions different from each other in the circumferential direction are fixed to the operation unit at positions different from each other in the circumferential direction.
  • a plurality of second elements that are connected to a target part and that pull the at least part of the control target part to displace the control target part in the distal direction as the operating part swings, and the operating part swings
  • the first element fixed to the portion of the operation portion that is displaced backward displaces the control target portion of the implant in the proximal direction and is displaced backward of the operation portion. That fixed the second element portion, the control target region at a point opposite to the first element to be displaced in the proximal direction, the control target region may be displaced in the distal direction.
  • the first element displaces the control target part of the implant in the proximal direction, and the second element on the opposite side controls the control target part of the implant. Since it is displaced in the distal direction, it is possible to reliably synchronize the control target site of the implant with the movement of the operation unit.
  • the operation unit can be displaced in an axial direction of the shaft, and the operation unit is displaced in a distal direction with respect to an initial position in a state where the implant is exposed to the outside of the delivery device. By doing so, the control target part may be expanded.
  • the control target region when the implant is exposed in the living body lumen, the control target region can be easily expanded only by moving the operation unit in the distal direction.
  • the transmission mechanism includes a plurality of driving members disposed at intervals in the circumferential direction around the axis of the shaft, and the plurality of driving members are attached to the implant on the distal end side. Connected at intervals in the circumferential direction, and connected to the operation portion at intervals in the circumferential direction on the proximal end side, and when the operation portion is swung, the plurality of drive members move forward and backward.
  • the direction of the control target part may be changed by pushing and pulling the control target part of the implant.
  • the transmission mechanism is configured by a plurality of drive members, a mechanism that synchronizes the movement of the operation unit and the movement of the implant can be realized with a relatively simple configuration.
  • tip part can be comprised flexibly, and the followable
  • the drive member is a tube-shaped member having a side hole provided on the distal end side, and a release member made of a linear body is movably inserted inside the drive member. A part of the release member is exposed from the side hole, and the implant has a main body and a skeleton fixed to the main body, and the skeleton is exposed from the side hole.
  • connection between the implant and the drive member can be reliably maintained until the release member is moved backward, and the release member is moved backward with respect to the drive member, thereby The connection can be easily released.
  • the shaft may be provided with a support portion having a spherical support surface, and the operation portion may be supported by the support portion so as to be swingable in an arbitrary direction.
  • control target part when the operation unit is swung, the control target part may operate in substantially the same angle in the same direction as the operation unit.
  • the angle adjustment of the control target portion of the implant is more accurate and easy by intuitive operation. Can be done.
  • control target site of the implant may move in the same direction as the operation unit under the action of the transmission mechanism by swinging the operation unit.
  • the control target part of the implant can be moved in the same direction as the operation unit. Therefore, when adjusting the angle of the region to be controlled with respect to the blood vessel axis, the operator only needs to lift the operation unit on the hand side in the direction in which the implant is desired to be operated, and an intuitive operation is possible.
  • FIG. 1 is a partially omitted perspective view of a delivery system according to a first embodiment of the present invention.
  • FIG. 2 is a partially omitted vertical sectional view of the delivery system shown in FIG. 1. It is a figure which shows the connection structure of a stent graft and a linear member.
  • 4A is a first diagram for explaining the operation of the delivery system shown in FIG. 1
  • FIG. 4B is a second diagram for explaining the operation of the delivery system shown in FIG. 1, and FIG. It is a 3rd figure explaining operation
  • FIG. 6 is a partially omitted vertical sectional view of the delivery system shown in FIG. 5.
  • FIG. 5 is a partially omitted vertical sectional view of the delivery system shown in FIG. 5.
  • FIG. 7 is a transverse sectional view taken along line VII-VII in FIG. 6. It is a figure which shows the connection structure of a stent graft and a drive member. It is a perspective view which shows the structure of the base end part of the delivery system shown in FIG. 10A is a first diagram for explaining the operation of the delivery system shown in FIG. 5, FIG. 10B is a second diagram for explaining the operation of the delivery system shown in FIG. 5, and FIG. It is a 3rd figure explaining operation
  • FIG. 1 is a partially omitted perspective view of a delivery system 10A according to the first embodiment of the present invention.
  • a part of the longitudinal delivery system 10 ⁇ / b> A in the longitudinal direction (between the distal end portion and the proximal end portion) is partially omitted.
  • FIG. 2 is a partially omitted vertical sectional view of the delivery system 10A.
  • the stent graft 12 (implant) placed and housed (mounted) on the distal end side is made to reach a lesion such as an aortic aneurysm through a blood vessel, and the stent graft 12 is deployed and placed. It is configured as a stent graft delivery system for treating lesions.
  • the right side (handle 20 side) of the delivery system 10A in FIG. 1 is referred to as the “proximal end (rear end)” side
  • the left side of the delivery system 10A (stent graft 12 side) is referred to as the “front end” side.
  • the delivery system 10A includes a stent graft 12 having a self-expanding function, and a delivery device 14 on which the stent graft 12 is placed on the distal end side and can be inserted into a living body lumen.
  • the delivery device 14 includes a long shaft 16, a tubular sheath 18 that is slidable in the axial direction with respect to the shaft 16 and can accommodate the stent graft 12, and a handle 20 provided on the proximal end side of the shaft 16.
  • the stent graft 12 to be delivered and placed in a living body includes a tubular graft 12a (main body) (see FIG. 3), and a stent 12b (skeleton) which is a metal skeleton for expansion fixed to the inner surface or outer surface of the graft 12a.
  • a common stent graft 12 can be used.
  • the graft 12a may be configured by forming a woven fabric (fabric) woven with resin threads such as polyester or a film of ePTFE (stretched polytetrafluoroethylene) into a tube shape.
  • the stent 12b has a structure in which a plurality of skeletons formed of a superelastic alloy such as a Ti—Ni alloy in a ring shape or a Z shape are arranged in the axial direction of the graft 12a, or a wire made of a superelastic alloy or the like in a mesh shape.
  • a knitted structure may be used.
  • FIG. 3 shows a ring-shaped stent 12b.
  • the stent graft 12 is housed in a space formed by a mount portion 16b provided on the shaft 16 and a sheath 18, and is in a state of being expanded with its expansion restricted (contracted state).
  • the sheath 18 moves backward with respect to the shaft 16 and the stent graft 12 accommodated therein is released from the restriction by the sheath 18, the stent graft 12 is expanded and deployed by the self-expanding function.
  • the shaft 16 is a flexible tubular member in which a guide wire lumen 16a through which the guide wire is inserted penetrates the central portion throughout the entire length.
  • a tapered nose portion 17 is provided at the tip of the shaft 16.
  • annular recessed mount portion 16 b for mounting the stent graft 12 is provided.
  • the shaft 16 includes a core shaft 22 in which a guide wire lumen 16a is formed, and a hollow outer member 24 disposed outside the core shaft 22.
  • the nose portion 17 described above is provided at the tip of the core shaft 22.
  • the inner diameter of the outer member 24 is larger than the outer diameter of the core shaft 22, and an annular space extending in the axial direction is formed between the outer peripheral portion of the core shaft 22 and the inner peripheral portion of the outer member 24.
  • 1st side hole 26 and 2nd side hole 28 are provided in the front end side of outer member 24 at intervals in the direction of an axis.
  • a plurality (four in this embodiment) of first side holes 26 are provided at a distal end side with respect to the distal end side opening 13 of the stent graft 12 and spaced in the circumferential direction.
  • a plurality of second side holes 28 are disposed at the same phase position as the first side hole 26 at a distance from the distal end side opening 13 of the stent graft 12 in the proximal direction and spaced in the circumferential direction (in this embodiment, 4) provided.
  • a linear member 42 for controlling the inclination of the distal end side opening 13 of the stent graft 12 is inserted into the first side hole 26 and the second side hole 28, and details thereof will be described later.
  • the sheath 18 includes a sheath body 18a that is slidable in the axial direction of the shaft 16 outside the shaft 16, and a sheath hub 18b that is connected to the base end portion of the sheath body 18a and has a larger diameter than the sheath body 18a.
  • the main body 18a and the sheath hub 18b can be integrally displaced with respect to the shaft 16 in the axial direction.
  • the sheath body 18a is a thin and flexible tubular member having flexibility and disposed on the outer surface side of the shaft 16 so as to be slidable in the axial direction.
  • the sheath 18 In the initial state shown in FIGS. 1 and 2, the sheath 18 is disposed on the most distal side of the movable range with respect to the shaft 16. In the delivery device 14, in this initial state, the sheath main body 18a of the sheath 18 completely covers the mount portion 16b of the shaft 16, and the stent graft 12 disposed on the mount portion 16b is compressed and stored over the entire length.
  • the movable range of the sheath 18 with respect to the shaft 16 is such that when the sheath 18 is displaced to the most proximal side, the most distal end portion of the sheath 18 is located on the proximal side with respect to the mount portion 16b provided on the shaft 16, and the stent graft 12 Is set so that it can be completely released.
  • the material constituting the shaft 16 and the sheath 18 is not particularly limited.
  • polyolefin for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these
  • polymer materials such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyester, polyester elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube of the above two or more polymer materials.
  • polyolefin for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these
  • polymer materials such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethan
  • the handle 20 provided on the proximal end side of the shaft 16 includes a grip part 30 for a user to grip and an operation part 34 provided to the grip part 30.
  • the grip portion 30 includes a first grip portion 30A and a second grip portion 30B provided on the proximal end side with respect to the first grip portion 30A.
  • the first grip portion 30A and the second grip An operation unit 34 is arranged between the unit 30B.
  • the first grip portion 30A has a larger diameter (thicker) than the shaft 16, is fixed to the base end of the outer member 24 of the shaft 16 and the outer peripheral portion of the core shaft 22, and has the core shaft 22 at the center thereof. Is inserted in the axial direction.
  • an insertion passage 36 is formed that extends radially in the proximal direction about the core shaft 22.
  • the second grip portion 30B has substantially the same diameter as the first grip portion 30A, is formed with a larger diameter (thicker) than the shaft 16, is fixed to the outer peripheral portion of the core shaft 22, and has a core shaft at the center thereof. 22 is inserted in the axial direction.
  • the operation unit 34 is provided so as to be able to swing in at least two different directions with respect to the axial direction of the shaft 16.
  • a support portion 38 having a spherical support surface 38 a is provided on the proximal end side of the core shaft 22, and the operation portion 34 can be moved in any direction by the support portion 38.
  • Is swingably supported that is, as shown in FIG. 1 and FIG. 2, when assuming the X axis and the Y axis that are orthogonal to the axis of the shaft 16 and orthogonal to each other, the operation unit 34 is either about the X axis or the Y axis. In addition to being able to oscillate, it can also be oscillated about an axis having an angle between the X axis and the Y axis.
  • the support portion 38 is provided with a through-hole 38b penetrating in the front-rear direction, and the core shaft 22 is inserted into the through-hole 38b, whereby the support portion 38 is interposed between the first grip portion 30A and the second grip portion 30B. Thus, it can be displaced in the axial direction with respect to the core shaft 22.
  • the operation portion 34 is configured in a circular ring shape (disk shape), and a spherical concave portion 34 a having substantially the same curvature as the support surface 38 a of the support portion 38 is provided on the inner peripheral portion thereof. .
  • the support part 38 can swing smoothly in any direction with the center of the support part 38 as a reference.
  • the delivery device 14 further includes a transmission mechanism 40 that transmits the driving force (movement of the operation unit 34) input to the operation unit 34 to the stent graft 12.
  • a transmission mechanism 40 that transmits the driving force (movement of the operation unit 34) input to the operation unit 34 to the stent graft 12.
  • the transmission mechanism 40 includes a plurality of linear members 42 having flexibility in which at least part of the extending direction is inserted into the shaft 16.
  • the linear member 42 is made of, for example, a metal or resin wire, a thread, or the like. As the operating portion 34 swings, the plurality of linear members 42 move back and forth with respect to the shaft 16, so that the distal side opening 13 (control target site) of the stent graft 12 operates in synchronization with the operating portion 34. .
  • the plurality of linear members 42 are fixed to the operation unit 34 at different positions in the circumferential direction and connected to the distal end side opening 13 at different positions in the circumferential direction.
  • a plurality of second elements 46a to 46d that pull so that at least a part thereof displaces the distal end side opening 13 in the distal direction as the operation unit 34 swings.
  • first elements 44a to 44d are not distinguished from each other, they may be referred to as first elements 44, and when the second elements 46a to 46d are not distinguished from each other, they may be referred to as second elements 46.
  • the first element 44 (for example, the first element 44a) fixed to the portion of the operation portion 34 that is displaced rearwardly moves the distal opening 13 of the stent graft 12 in the proximal direction.
  • the second element 46 (for example, the second element 46a) fixed to the rearwardly displaced portion is opposite to the first element 44 that displaces the distal end side opening 13 in the proximal direction.
  • the tip side opening 13 is displaced in the tip direction at a point.
  • first elements 44 are provided at intervals of 90 degrees in the circumferential direction, and the portion between the distal end side opening portion 13 and the operation portion 34 is not folded back on the shaft 16. It is arranged along.
  • the first element 44 has a distal end connected to the distal end side opening portion 13 at equal intervals in the circumferential direction, and a proximal end fixed to the operation portion 34 at equal intervals in the circumferential direction.
  • the connection portion between the first element 44a and the distal end side opening portion 13 and the fixing portion between the first element 44a and the operation portion 34 have the same phase in the circumferential direction around the axis of the shaft 16.
  • the connecting portions between the remaining first elements 44b to 44d and the distal end side opening 13, and the fixing portions between the first elements 44b to 44d and the operating portion 34 are in the same phase.
  • the intermediate portion of the first element 44 is inserted through a space formed between the core shaft 22 and the outer member 24 and an insertion passage 36 provided in the first grip portion 30A.
  • Each first element 44 is drawn outward from a second side hole 28 provided in the shaft 16 on the distal end side, and is proximal to the proximal end of the insertion passage 36 located at the proximal end of the first grip portion 30A on the proximal end side. Each is pulled out from the opening.
  • second elements 46 are provided at intervals of 90 degrees in the circumferential direction, and are arranged in a state of being folded back at a position (first side hole 26) on the distal end side with respect to the distal end side opening 13.
  • the second element 46 has a distal end connected to the distal end side opening portion 13 at equal intervals in the circumferential direction, and a proximal end fixed to the operation portion 34 at equal intervals in the circumferential direction.
  • connection points between the plurality of second elements 46a to 46d and the tip side opening 13 are the same as the connection points of the plurality of first elements 44a to 44d and the tip side opening 13, respectively.
  • the connection point between the second element 46 a and the distal end side opening 13 and the fixing point between the second element 46 a and the operation part 34 are in opposite phases with respect to the circumferential direction around the axis of the shaft 16.
  • the connection points between the remaining second elements 46b to 46d and the distal end side opening 13 and the fixing points between the second elements 46b to 46d and the operation unit 34 are in opposite phase positions.
  • the intermediate portion of the second element 46 is inserted into a space formed between the core shaft 22 and the outer member 24 and an insertion passage 36 provided in the first grip portion 30A.
  • the distal end side of each second element 46 is drawn outward from a first side hole 26 provided in the shaft 16 on the distal end side, and is folded back to the proximal end side by the first side hole 26 to open the distal end side. It is connected to the part 13.
  • the base end side of the second element 46 is drawn outward from the base end opening of the insertion passage 36 located at the base end of the first grip portion 30A.
  • FIG. 3 is a view showing a connection structure between the stent graft 12 and the linear member 42 (first element 44 and second element 46).
  • the stent graft 12 includes a graft 12a and a plurality of ring-shaped stents 12b. In FIG. 3, for ease of understanding, only the most distal stent 12b is shown for the plurality of stents 12b.
  • FIG. 3 shows the stent graft 12 in a partially expanded state, and each of the plurality of ring-shaped stents 12b is deformed so that two crests and two troughs are alternately formed in the circumferential direction.
  • a pair of first rings 48a and 48b are arranged at the peak of the stent 12b on the most distal side.
  • the small loop 51 provided at the tip of the first element 44a and the small loop 52 provided at the tip of the second element 46c are passed through the first ring 48a.
  • the small loop 53 provided at the tip of the first element 44c and the small loop 54 provided at the tip of the second element 46a are passed through the other first ring 48b.
  • the first release wire 60 is passed through the two loops 51 and 52 passed through one first ring 48a and the two loops 53 and 54 passed through the other first ring 48b.
  • the first element 44a and the second element 46a passed through one first ring 48a and the first element 44c and the second element 46c passed through the other first ring 48b are respectively one of them.
  • the distal opening 13 of the stent graft 12 is connected to the first elements 44a and 44c and the second elements 46a and 46c in a state in which they are prevented from coming out of the first ring 48a and the other first ring 48b.
  • the maintained state is maintained.
  • a pair of second rings 50a and 50b are disposed in the valley of the stent 12b on the most distal side. Similar to the first wheels 48a, 48b, the second wheels 50a, 50b are connected to the respective loops 55, 57 of the different first elements 44d, 44b and the respective loops 56, 58 of the second elements 46d, 46b. And the second release wire 62 is passed through them.
  • the first element 44d and the second element 46d passed through one second ring 50a, and the first element 44b and the second element 46b passed through the other second ring 50b, respectively,
  • the distal opening 13 of the stent graft 12 is connected to the first elements 44b and 44d and the second elements 46b and 46d in a state in which they are prevented from coming out of the second ring 50a and the other second ring 50b.
  • the maintained state is maintained.
  • first release wire 60 and the second release wire 62 are inserted into the shaft 16 and are drawn out to the outside on the proximal end side of the delivery device 14.
  • first and second release wires 60 and 62 are pulled in the proximal direction on the proximal side, the first release wire 60 and the second release wire 62 come out of the loops 53 to 58, respectively, so that the stent 12b and the linear member 42 are removed.
  • the connection with (the first element 44 and the second element 46) is released.
  • the delivery device 14 is basically configured as described above, and the operation and effect thereof will be described below.
  • the delivery device 14 is used, for example, for stent graft insertion in which the stent graft 12 is delivered to the inside of an aortic aneurysm that has occurred in the aorta, and the stent graft 12 is expanded and deployed at that position to be expanded and deployed.
  • 4A to 4C are diagrams for explaining the operation of the delivery system 10A in stent graft insertion.
  • stent graft insertion prior to inserting the delivery device 14 into the body, first, for example, a guide wire is inserted into the femoral artery, and imaging is performed under fluoroscopy to reach the aorta. Next, along the guide wire, the distal end portion of the delivery device 14 in which the stent graft 12 is housed on the distal end side is caused to travel into the blood vessel, and the distal end portion of the delivery device 14 reaches the position where the lesioned part (aortic aneurysm) is present. At this time, the delivery device 14 is still in the initial state shown in FIGS. 1 and 2, and the stent graft 12 remains housed in the sheath 18.
  • a procedure for deploying the stent graft 12 in the blood vessel is performed.
  • the sheath 18 is grasped and pulled in the proximal direction, thereby moving the sheath 18 in the proximal direction with respect to the shaft 16.
  • the sheath 18 moves in the proximal direction
  • the stent graft 12 that has been prevented from expanding by the sheath 18 is gradually expanded and deployed, and the sheath 18 is moved to the most proximal side of the movable range.
  • FIG. 4A it will be in the state which the stent graft 12 expanded / deployed over the full length.
  • the distal end side opening 13 of the stent graft 12 is prevented from being expanded to the maximum by the plurality of linear members 42 and is in a state of being deployed smaller than the inner diameter of the blood vessel. .
  • the stent graft 12 may be inclined with respect to the blood vessel axis when the stent graft 12 is delivered to a target position in the blood vessel. If the distal opening 13 that is the blood inlet of the stent graft 12 is disposed obliquely with respect to the blood vessel axis, a blood flow leak may occur. In order to avoid this, the angle of the distal opening 13 is adjusted to be perpendicular to the blood vessel axis.
  • the operation part 34 may be swung in the direction to be changed.
  • the plurality of linear members 42 operate in conjunction with each other, so that the distal end side opening 13 of the stent graft 12 is operated in synchronization with the operation portion 34. It operates in the same direction as the part 34 and at substantially the same angle.
  • the distal end side opening 13 operates in the same direction as the operation unit 34 due to the pulling action of the first element 44 and the second element 46. Even when the operation unit 34 is swung around the Y axis, the distal end side opening 13 operates in the same direction as the operation unit 34.
  • the operating portion 34 is moved in the distal direction with respect to the shaft 16.
  • the support portion 38 is slidable in the axial direction with respect to the shaft 16
  • the operation portion 34 moves together with the support portion 38 in the distal direction with respect to the shaft 16.
  • the linear members 42 first element 44 and second element 46
  • the first member The length of the linear member 42 drawn out from the side hole 26 and the second side hole 28 is increased, and as a result, the diameter of the distal end side opening 13 is increased. Due to the diameter expansion, the outer peripheral portion of the distal opening 13 comes into contact with the inner wall of the blood vessel, and the stent graft 12 is positioned at a desired position with respect to the blood vessel.
  • the connection between the linear member 42 and the stent graft 12 is released by pulling the first and second release wires 60 and 62 in the proximal direction.
  • the stent graft 12 is completely separated from the delivery device 14. Then, after separating the stent graft 12, when the delivery device 14 is pulled out from the body, the placement of the stent graft 12 in the body is completed.
  • the distal end side opening 13 of the stent graft 12 is moved in the same direction as the operation part 34. Can do. Therefore, when the operator adjusts the angle with respect to the blood vessel axis, the operator only has to raise the hand side operation unit 34 in the direction in which the stent graft 12 is desired to be tilted, and an intuitive operation is possible.
  • the operation unit 34 can be swung in at least two different directions with respect to the shaft 16, the implant can be tilted in at least two directions, and the angle of a specific portion of the stent graft 12 in vivo. The degree of freedom of adjustment is high, and the stent graft 12 can be positioned with high accuracy.
  • the distal end side opening 13 when the operation unit 34 is swung, the distal end side opening 13 operates in the same direction as the operation unit 34 by substantially the same angle. According to this configuration, since the tilt angle of the operation portion 34 and the tilt angle of the distal end side opening portion 13 of the stent graft 12 substantially coincide, the angle adjustment of the distal end side opening portion 13 can be performed more accurately and intuitively. It can be done easily.
  • the implant into the living body lumen is the stent graft 12, and the control target site is the distal end opening 13 (central opening) serving as the blood inlet of the stent graft 12.
  • the direction of the distal opening 13 of the stent graft 12 can be adjusted so as to be perpendicular to the blood vessel axis, that is, not tilted. Therefore, it is possible to suitably suppress or prevent the occurrence of blood leak due to the distal opening 13 of the stent graft 12 being inclined with respect to the blood vessel axis.
  • the transmission mechanism 40 is composed of a plurality of flexible linear members 42 inserted at least partially in the extending direction into the shaft 16.
  • the distal end side opening 13 which is a control target portion, operates in synchronization with the operation unit 34.
  • the first element 44 fixed to the portion of the operation unit 34 that is displaced rearward displaces the distal end side opening 13 of the stent graft 12 in the proximal direction.
  • the second element 46 fixed to the rearward displacement portion is located on the side opposite to the first element 44 that displaces the distal end side opening 13 in the proximal direction, and the distal end side opening 13 is moved in the distal direction. Displace to.
  • the operation unit 34 can be displaced in the axial direction of the shaft 16, and the plurality of linear members 42 move in the same direction as the operation unit 34 as the operation unit 34 is displaced in the distal direction.
  • the front end side opening part 13 expands.
  • the distal end side opening 13 can be easily deformed simply by operating the operation unit 34 to move in the axial direction.
  • the shaft 16 is provided with a support portion 38 having a spherical support surface 38a, and the operation portion 34 is supported by the support portion 38 so as to be swingable in an arbitrary direction.
  • the angle of the opening 13 on the distal end side of the stent graft 12 synchronized with the operation portion 34 can be adjusted in any direction with respect to the axis of the shaft 16. Is possible.
  • the stent graft 12 is exemplified to have a ring-shaped stent 12b. However, the same applies to a stent in which a large number of Z-shaped cells are connected in the circumferential direction or a mesh-shaped (diamond) stent. The effect is obtained.
  • FIG. 5 is a partially omitted perspective view of a delivery system 10B according to a second embodiment of the present invention
  • FIG. 6 is a partially omitted vertical sectional view of the delivery system 10B.
  • elements having the same or similar functions and effects as those of the delivery system 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
  • the delivery system 10B is configured as a stent graft delivery system used to deliver and place the stent graft 12 at a desired position in the blood vessel of the living body, similarly to the delivery system 10A described above.
  • the delivery system 10B includes a stent graft 12 and a delivery device 70 on which the stent graft 12 is placed on the distal end side and can be inserted into a living body lumen.
  • the delivery device 70 includes a long shaft 72, a tubular sheath 18 that is slidable in the axial direction with respect to the shaft 72 and can accommodate the stent graft 12, and a handle 73 provided on the proximal end side of the shaft 72.
  • the shaft 72 includes a core shaft 22 in which a guide wire lumen 16 a is formed, a hollow outer member 76 disposed outside the core shaft 22, and an outer And a hollow cover tube 78 disposed outside the member 76.
  • the core shaft 22 is configured similarly to the core shaft 22 in the first embodiment.
  • a plurality (four in this embodiment) of side holes 98 are provided at equal intervals in the circumferential direction.
  • the inner diameter of the outer member 76 is larger than the outer diameter of the core shaft 22, and an annular space extending in the axial direction is formed between the outer peripheral portion of the core shaft 22 and the inner peripheral portion of the outer member 76.
  • the base end of the outer member 76 reaches the base end of the handle 73. From the base end of the outer member 76, the core shaft 22 protrudes in the base end direction.
  • the inner diameter of the cover tube 78 is larger than the outer diameter of the outer member 76, and an annular space extending in the axial direction is formed between the outer peripheral portion of the outer member 76 and the inner peripheral portion of the cover tube 78.
  • the overall length of the cover tube 78 is shorter than the overall length of the outer member 76, and the distal end of the cover tube 78 is located on the proximal side of the proximal end of the stent graft 12 in a state of being housed in the sheath 18.
  • the proximal end of the cover tube 78 extends into the distal end portion of the first grip portion 80 ⁇ / b> A constituting the handle 73.
  • the sheath 18 is configured similarly to the sheath 18 in the first embodiment, and can slide in the axial direction with respect to the shaft 72 outside the shaft 72.
  • the sheath 18 accommodates the stent graft 12 between the shaft 72 and the shaft 72 at an initial position located at the most distal side in the movable range, and exposes the entire length of the stent graft 12 to the outside in a state where the sheath 18 is retracted most proximally in the movable range. To do.
  • the handle 73 includes a grip part 80 for a user to hold and an operation part 34 provided to the grip part 80.
  • the grip portion 80 includes a first grip portion 80A and a second grip portion 80B provided on a proximal end side with respect to the first grip portion 80A.
  • the operation unit 34 is disposed between the unit 80B.
  • the first grip portion 80A is formed with a larger diameter (thicker) than the shaft 72, and is fixed to the base end of the cover tube 78 of the shaft 72 and the outer peripheral portion of the outer member 76, and the outer member 76 at the center thereof. Is inserted in the axial direction.
  • the first grip portion 80A is formed with an insertion passage 82 that extends radially toward the proximal end with the core shaft 22 as the center.
  • the second grip portion 80B is substantially the same diameter as the first grip portion 80A, and has a hollow structure formed with a larger diameter (thicker) than the shaft 72.
  • the second grip portion 80B is fixed to the outer peripheral portion of the outer member 76, and the outer member 76 is inserted in the axial direction at the center thereof.
  • the operation unit 34 is configured in the same manner as the operation unit 34 in the first embodiment, and is provided so as to be swingable in at least two different directions with respect to the axial direction of the shaft 72.
  • a support portion 84 formed with a spherical support surface 84 a is provided on the proximal end side of the shaft 72 (outer member 76), and the operation portion 34 includes the support portion 84.
  • the operation unit 34 is either about the X axis or the Y axis. In addition to being able to oscillate, it can also be oscillated about an axis having an angle between the X axis and the Y axis.
  • the support portion 84 is provided with a through-hole 84b penetrating in the front-rear direction, and the support portion 84 is fixed to the outer peripheral portion of the outer member 76 in a state where the core shaft 22 is inserted into the through-hole 84b. Unlike the support part 38 (refer FIG. 2) in 1st Embodiment, the support part 84 is fixed with respect to the shaft 72, and cannot be displaced to an axial direction.
  • the delivery device 70 further includes a transmission mechanism 86 that transmits the driving force input to the operation unit 34 to the stent graft 12.
  • a transmission mechanism 86 that transmits the driving force input to the operation unit 34 to the stent graft 12.
  • the transmission mechanism 86 includes a plurality of (four in the present embodiment) drive members 88a to 88d disposed around the axis of the shaft 72 at intervals in the circumferential direction.
  • drive members 88a to 88d are not distinguished from each other, they are collectively referred to as a “drive member 88”.
  • the plurality of driving members 88 are connected to the distal end side opening 13 of the stent graft 12 at a distal end side in the circumferential direction, and are connected to the operation portion 34 at a proximal end side in the circumferential direction at intervals.
  • the operating portion 34 is swung, the distal opening 13 of the stent graft 12 is pushed and pulled by the plurality of drive members 88 that move forward and backward, so that the direction of the distal opening 13 changes.
  • the driving member 88 is an elongated member, and has an appropriate rigidity so that the driving force input to the operation unit 34 can be transmitted not only in the proximal direction but also in the distal direction.
  • These drive members 88 are inserted through the space formed between the outer member 76 and the cover tube 78 (see FIG. 6 and FIG. 7), and inserted in the first grip portion 80A. It is inserted through the passage 82 and pulled out from the base end side of the first grip portion 80A.
  • these drive members 88 are fixed to the operation unit 34 at intervals in the circumferential direction, and their base ends are arranged in the second grip 80B.
  • the drive member 88 is a tube-like member having a side hole 89 provided on the distal end side, and is formed of a linear body inside the drive member 88.
  • a release member 90 is inserted. As shown in FIG. 8, a part of the release member 90 is exposed from the side hole 89.
  • the release member 90 is configured by, for example, a metal or resin wire, a thread, or the like.
  • the drive member 88 is connected to the stent graft 12 by the stent 12b being sandwiched between the release member 90 exposed from the side hole 89 and the drive member 88. When the distal end of the release member 90 moves to the proximal end side from the side hole 89, the connection between the drive member 88 and the stent graft 12 is released.
  • the handle 73 is provided with a mechanism for displacing the release member 90 in the proximal direction with respect to the drive member 88.
  • the second grip 80B includes a grip housing 92 provided with an opening 92a, and a release operation member 94 that is detachable from the grip housing 92 and closes the opening 92a.
  • a release member 90 drawn from the base end of the drive member 88 is fixed to the release operation member 94.
  • the release operation member 94 when the release operation member 94 is removed from the grip housing 92 and further pulled, the distal end of the release member 90 moves to the proximal end side from the side hole 89 on the distal end side of the drive member 88. Thus, the connection between the drive member 88 and the stent graft 12 is released. In a state where the connection has been released, the release operation member 94 may be further pulled to pull the release member 90 completely from the drive member 88.
  • the base end of the drive member 88 and the base end of the release member 90 are stored in the second grip portion 80B until the connection between the drive member 88 and the stent graft 12 is released. Therefore, the drive member 88 and the release member 90 do not interfere with the operation and are excellent in operability. Further, when the connection between the drive member 88 and the stent graft 12 is released, the release operation member 94 is removed from the grip housing 92 and pulled, so that the plurality of release members 90 can be pulled simultaneously, thereby quickly and quickly. The connection between the drive member 88 and the stent graft 12 can be reliably released.
  • a plurality (four in this embodiment) of linear diameter expansion control members 96 are inserted into the space formed between the core shaft 22 and the outer member 76. These diameter-expansion control members 96 resist the self-expanding force of the stent graft 12 by suspending the distal opening 13 from the inside when the sheath 18 moves in the proximal direction and the stent graft 12 is exposed. This is to temporarily prevent expansion of the distal end opening 13.
  • each of the plurality of diameter expansion control members 96 is pulled out from a side hole 98 provided on the distal end side of the outer member 76, and is driven at a position of a side hole 89 provided in each drive member 88.
  • Each member 88 is connected (see FIG. 8).
  • a loop 96a is provided at the end of the diameter expansion control member 96 that is connected to the drive member 88, and the drive member 88 is passed through the loop 96a.
  • the delivery system 10B according to the present embodiment is basically configured as described above, and the operation and effect will be described below.
  • the delivery system 10B is used, for example, for stent graft insertion in which the stent graft 12 is delivered to the inside of the aortic aneurysm that has occurred in the aorta, and the stent graft 12 is released at that position to expand and deploy the stent graft 12.
  • FIGS. 10A to 10C are views for explaining the operation of the delivery system 10B in stent graft insertion.
  • stent graft insertion prior to inserting the delivery device 70 into the body, first, for example, a guide wire is inserted into the femoral artery, and imaging is performed under fluoroscopy to reach the aorta. Next, along the guide wire, the shaft 72 of the delivery device 70 in which the stent graft 12 is housed on the distal end side and the distal end portion of the sheath 18 are moved into the blood vessel, and the distal end portion of the delivery device 70 is moved to a lesioned part (aortic aneurysm). It reaches a certain position. At this time, the delivery device 70 is still in the initial state shown in FIGS. 5 and 6, and the stent graft 12 remains housed in the sheath 18.
  • a guide wire is inserted into the femoral artery, and imaging is performed under fluoroscopy to reach the aorta.
  • a procedure for deploying the stent graft 12 in the blood vessel is performed.
  • the sheath 18 is grasped and pulled in the proximal direction, thereby moving the sheath 18 in the proximal direction with respect to the shaft 72.
  • the stent graft 12 that has been prevented from expanding by the sheath 18 is gradually expanded and deployed, and the sheath 18 is moved to the most proximal side in the movable range.
  • the stent graft 12 will be in the state expanded and expanded over the full length.
  • the distal end side opening 13 of the stent graft 12 is prevented from being expanded to the maximum by the diameter expansion control member 96, and is in a state of being deployed smaller than the inner diameter of the blood vessel.
  • the operation part 34 may be swung in the direction to be changed.
  • the direction (angle) of the operation unit 34 is changed with respect to the shaft 72
  • the distal end side opening 13 of the stent graft 12 operates in synchronization with the operation unit 34 by the action of the plurality of drive members 88. That is, for example, as illustrated in FIG. 10B, when the direction of the operation unit 34 is changed around the X axis, the driving member 88 a fixed to a position displaced forward of the operation unit 34 is moved by the operation unit 34.
  • the drive member 88c fixed to a position displaced backward in the operation unit 34 is pushed backward by the operation unit 34 while being moved forward with respect to the shaft 72 by being pushed forward. And retreat.
  • the distal end side opening 13 of the stent graft 12 moves by substantially the same angle in the same direction as the operation portion 34.
  • the diameter expansion control member 96 may be sent out with respect to the shaft 72 in the distal direction. If it does so, since the length of the part withdraw
  • the release operation member 94 (see FIG. 9) is pulled to release the connection between the drive member 88 and the stent graft 12.
  • the delivery device 70 and the stent graft 12 are completely separated.
  • the delivery device 70 is pulled out from the body, the placement of the stent graft 12 in the body is completed.
  • the distal end side opening 13 of the stent graft 12 is moved in the same direction as the operation unit 34. Can do. Therefore, when the operator adjusts the angle of the distal opening 13 with respect to the blood vessel axis, the operator only has to lift the proximal operating portion 34 in the direction in which the stent graft 12 is desired to be swung, and an intuitive operation is possible. .
  • the distal end side opening 13 when the operation unit 34 is swung, the distal end side opening 13 operates in the same direction as the operation unit 34 by substantially the same angle. According to this configuration, since the tilt angle of the operation portion 34 and the tilt angle of the distal end side opening portion 13 of the stent graft 12 substantially coincide, the angle adjustment of the distal end side opening portion 13 can be performed more accurately and intuitively. It can be done easily.
  • the stent graft 12 can be tilted in at least two directions. Therefore, the degree of freedom of angle adjustment of the distal end side opening 13 of the stent graft 12 in the living body is high, and the positioning of the stent graft 12 can be performed with high accuracy.
  • the transmission mechanism 86 that transmits the driving force input to the operation unit 34 to the stent graft 12 is configured by a plurality of driving members 88 arranged at intervals around the axis of the shaft 72.
  • the movement of the operation unit 34 and the movement of the stent graft 12 can be synchronized with a relatively simple configuration.
  • the second element 46 is folded back at the position of the first side hole 26 provided in the shaft 16, and the folded part is applied in order to apply an appropriate tension to the second element 46. Therefore, it is necessary to give the shaft 72 sufficient rigidity to support the second element 46. For this reason, it is difficult to flexibly configure the distal end portion of the delivery device 14.
  • tip part of the delivery apparatus 70 can be comprised flexibly. By flexibly configuring the distal end portion of the delivery device 70, it is possible to improve the followability to the bending of the blood vessel.
  • the stent 12 b is sandwiched between the drive member 88 configured by a tubular member and the release member 90 inserted inside the drive member 88.
  • the drive member 88 and the stent graft 12 are connected to each other. According to this configuration, the connection between the distal end side opening 13 of the stent graft 12 and the drive member 88 can be reliably maintained, and the release member 90 is retracted with respect to the drive member 88 to thereby prevent the drive member 88 and the stent graft 12 from being connected.
  • the connection can be easily released.
  • the stent graft 12 has a configuration having a ring-shaped stent. However, the same effect is obtained even in the case of a stent in which a large number of Z-shaped cells are connected in the circumferential direction or a mesh-shaped (diamond) stent. An effect is obtained.
  • the delivery systems 10A and 10B are configured as a stent graft delivery system for delivering the stent graft 12 to a desired position in the living body lumen
  • the scope of application of the present invention is not limited to this.
  • the present invention can be applied as a means for adjusting the inclination of a prosthetic valve by using a prosthetic valve in a transvascular aortic valve replacement (TAVI) as an implant of a delivery object.
  • TAVI transvascular aortic valve replacement
  • the control target part (part where the inclination is adjusted) of the implant is a skeleton in the artificial valve.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)
PCT/JP2012/074225 2012-09-21 2012-09-21 Système de délivrance Ceased WO2014045403A1 (fr)

Priority Applications (1)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5132084A (fr) * 1974-09-11 1976-03-18 Asahi Optical Co Ltd
JPS57123101U (fr) * 1980-09-10 1982-07-31
JP2008099877A (ja) * 2006-10-19 2008-05-01 Olympus Medical Systems Corp ステントデリバリーシステム

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5132084A (fr) * 1974-09-11 1976-03-18 Asahi Optical Co Ltd
JPS57123101U (fr) * 1980-09-10 1982-07-31
JP2008099877A (ja) * 2006-10-19 2008-05-01 Olympus Medical Systems Corp ステントデリバリーシステム

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