WO2018052123A1 - Dispositif médical - Google Patents

Dispositif médical Download PDF

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Publication number
WO2018052123A1
WO2018052123A1 PCT/JP2017/033490 JP2017033490W WO2018052123A1 WO 2018052123 A1 WO2018052123 A1 WO 2018052123A1 JP 2017033490 W JP2017033490 W JP 2017033490W WO 2018052123 A1 WO2018052123 A1 WO 2018052123A1
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WIPO (PCT)
Prior art keywords
shaft
medical device
rotating structure
cutting
cut
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Application number
PCT/JP2017/033490
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English (en)
Japanese (ja)
Inventor
広介 西尾
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テルモ株式会社
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Publication of WO2018052123A1 publication Critical patent/WO2018052123A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions

Definitions

  • This disclosure relates to medical devices.
  • Atherectomy for cutting a stenosis (object) composed of thrombus, plaque, calcified lesion, and the like as a treatment method in the body lumen (intravascular) for arteriosclerosis.
  • Atelectomy is a very important treatment for increasing arterial patency after treatment.
  • a method of cutting and removing a stenosis object by applying a rotating body located on the distal side of the catheter to the stenosis object is employed (see Patent Document 1).
  • a catheter be bent in the vicinity of a rotating body provided with a cutting portion to enable treatment in an intended direction.
  • a bending wire provided on the distal side of the catheter is bent by placing a pulling wire inside the catheter and pulling the pulling wire from the proximal side of the catheter. There is a way to make it.
  • An object of the present disclosure made in view of the above point is to provide a medical device having a configuration that enables a catheter having a bending function to be reduced in diameter.
  • the medical device of the present disclosure is a medical device for cutting an object in a living body lumen, A rotating structure having a cutting portion; A first shaft coupled to the rotating structure and driving rotation of the rotating structure; A tubular second shaft surrounding the first shaft; A bearing portion disposed between the rotating structure and the second shaft; With The second shaft can be bent in a predetermined direction; At least one of the first shaft and the second shaft has an expansion / contraction portion configured to expand and contract in the axial direction by rotation, The second shaft is configured to bend by a force received from the rotating structure via the bearing portion as the expansion and contraction portion expands and contracts.
  • the first shaft is provided with the stretchable portion.
  • the expansion / contraction part contracts in the axial direction by the rotation of the first shaft when cutting an object in a living body lumen.
  • the second shaft is rotatable and the telescopic portion is provided on the second shaft.
  • first shaft and the second shaft are relatively rotatable and the positional relationship in the axial direction is relatively movable.
  • the contact position of the second shaft with respect to the inner wall of the biological lumen is provided in the position on the opposite side.
  • the contact position of the second shaft with respect to the inner wall of the biological lumen it is preferable that a cut is formed in the second shaft so that the second shaft bends in a direction opposite to the first shaft.
  • a protruding portion that protrudes in the axial direction is provided on one end surface in the axial direction of the bearing portion, and the second shaft extends and contracts the expanding and contracting portion. Accordingly, it is preferable to perform bending by receiving a force from the rotating structure that comes into contact with the protruding portion.
  • the expansion / contraction part is a single layer coil shape spirally wound in one direction or a multilayer coil shape in which the winding direction is unified.
  • the medical device further includes a tubular outer sheath that surrounds the second shaft.
  • the medical device according to the present disclosure provides a medical device having a configuration that enables a catheter having a bending function to be reduced in diameter.
  • FIG. 1 is a diagram illustrating a medical device according to an embodiment of the present disclosure.
  • FIG. It is sectional drawing to which the distal side of the medical device shown in FIG. 1 was expanded.
  • FIG. 3 is a diagram illustrating a state where the medical device illustrated in FIG. 2 is bent. It is an expanded view which shows the pattern of the cut in the curved part of a 2nd shaft.
  • (A), (b) is a figure which shows the modification of the bearing part shown in FIG. It is the top view to which the part containing the rotation structure of FIG. 2 was expanded.
  • (A), (b) is a figure which shows a mode that the directionality of a medical device is prescribed
  • distal side the side of the medical device to be inserted into the blood vessel
  • proximal side the proximal side for operation
  • FIG. 1 is a diagram illustrating a medical device 10 according to an embodiment of the present disclosure.
  • FIG. 2 is an enlarged cross-sectional view of the distal side of the medical device 10 shown in FIG.
  • the medical device 10 is used for a treatment for cutting an object in a living body lumen, for example, a treatment for cutting a stenosis S (see FIGS. 7 and 8) composed of plaque, calcified lesion, thrombus, etc. in a blood vessel. .
  • a treatment for cutting a stenosis S (see FIGS. 7 and 8) composed of plaque, calcified lesion, thrombus, etc. in a blood vessel.
  • a treatment for cutting a stenosis S composed of plaque, calcified lesion, thrombus, etc. in a blood vessel.
  • the medical device 10 is configured to be rotatable along a rotation axis X and is capable of cutting the constriction S, and a first shaft 60 that drives rotation of the rotating structure 110.
  • a second drive device 92 for operating the second shaft 70 for operating the second shaft 70.
  • the first shaft 60 is connected to the central axis of the rotating structure 110, and when the first shaft 60 rotates, the rotating structure 110 rotates by being driven by the first shaft 60.
  • the rotation of the first shaft 60 is controlled by the first drive device 91 shown in FIG.
  • the rotation about the rotation axis X of the rotating structure 110 driven by the first shaft 60 is also referred to as “spinning”.
  • the rotation of the second shaft 70 is controlled independently of the first shaft 60 by the second drive device 92 shown in FIG.
  • the rotation of the rotating structure 110 about the rotation axis Y different from the rotation axis X by the rotation of the second shaft 70 as shown in FIGS. 7 and 8 is also referred to as “revolution”.
  • the second shaft 70 has a cut (slit) 75 that defines a direction in which bending is easy when the second shaft 70 is bent, or restricts the bending direction.
  • a bearing portion 140 is provided between the rotating structure 110 and the second shaft 70. By providing the bearing portion 140, the rotating structure 110 can smoothly rotate with respect to the second shaft 70.
  • the bearing part 140 is fixed to the second shaft 70.
  • the bearing 140 is positioned and held with respect to the second shaft 70. Details of the structure of the rotating structure 110 will be described later.
  • the first shaft 60 is formed in a tubular shape. As for the 1st shaft 60, the distal side is fixed to the rotation structure 110, and the proximal side is connected to the 1st drive device 91, as shown in FIG.
  • the first shaft 60 has an expansion / contraction part 61 configured to expand and contract in the axial direction by rotation.
  • the expansion / contraction part 61 is, for example, a single-layer coil wound spirally in one direction or a multilayer coil-shaped tube with a unified winding direction, contracted in the axial direction by rotation in the tightening direction, and loosened direction It is comprised so that it may extend in an axial direction by rotation.
  • the stretchable part 61 may be formed over the entire first shaft 60 or only a part thereof.
  • the stretchable part 61 may be provided on the second shaft 70 instead of the first shaft 60. Further, both the first shaft 60 and the second shaft 70 may be provided.
  • the first shaft 60 is flexible and has a characteristic capable of transmitting the rotational power acting from the proximal side to the distal side.
  • the portion of the first shaft 60 excluding the expansion / contraction portion 61 is, for example, a multilayer coiled tube body such as a three-layer coil that alternates between right and left and the winding direction, polyolefin such as polyethylene and polypropylene, polyamide, polyethylene terephthalate, and the like. It is composed of a fluorine-based polymer such as polyester or PTFE, PEEK (polyetheretherketone), polyimide, or a combination thereof in which a reinforcing member such as a wire is embedded.
  • the first shaft 60 is flexible, when the second shaft 70 is bent, the first shaft 60 bends following the bending shape of the second shaft 70.
  • the inner diameter of the first shaft 60 can be selected as appropriate, but is 0.4 to 1.9 mm, for example, and can be 1.2 mm as an example.
  • the outer diameter of the first shaft 60 can be selected as appropriate, but is 0.5 to 2.0 mm, for example, and can be 1.0 mm as an example.
  • a guide wire lumen into which a guide wire can be inserted may be provided inside the first shaft 60.
  • the guide wire is used to guide the rotating structure 110 when the rotating structure 110 is advanced in the blood vessel.
  • the second shaft 70 is formed in a tubular shape.
  • the 2nd shaft 70 surrounds the 1st shaft 60, and the proximal side is connected to the 2nd drive device 92 as shown in FIG.
  • the second shaft 70 is not necessarily driven by the second driving device 92, and the second shaft 70 may be operated by a user's hand.
  • the second shaft 70 can be bent.
  • being able to bend means that it can be bent and can maintain a bent state.
  • the second shaft 70 has a cut 75 that characterizes the bending shape.
  • the direction in which the second shaft 70 is easily bent is determined according to the shape of the pattern of the cuts 75.
  • the cut 75 can be, for example, a spiral continuous line shape, a shape in which a plurality of holes are arranged in the axial direction, or a combination thereof.
  • the outer peripheral side surface of the second shaft 70 does not have a cutting portion, and has a smooth configuration with small unevenness, and is configured as a non-cutting portion. Thereby, even if the outer peripheral side surface of the 2nd shaft 70 contacts a normal blood vessel, the risk of damaging a blood vessel can be reduced.
  • the second shaft 70 has a characteristic capable of transmitting the rotational power acting from the proximal side to the distal side.
  • the second shaft 70 is made of, for example, a metal or alloy such as titanium, stainless steel, or NiTi.
  • the inner diameter of the second shaft 70 can be selected as appropriate, but is 1.0 to 2.5 mm, for example, and can be 1.5 mm as an example.
  • the outer diameter of the second shaft 70 can be selected as appropriate.
  • the outer diameter is 1.1 to 2.6 mm, and can be 1.8 mm as an example.
  • the second shaft 70 has a step near the distal end of the outer sheath 80, but may have a structure without this step.
  • the distal end of the outer sheath 80 accommodates the distal end of the second shaft 70. This can prevent the distal end of the second shaft 70 from being exposed from the outer sheath 80. Thereby, it becomes easy to control the bending state of the portion exposed from the outer sheath 80 of the second shaft 70 to an arbitrary state.
  • the outer sheath 80 can be reduced in diameter. The outer sheath 80 closes the cut 75 of the second shaft 70 from the outside of the second shaft 70, so that a reduction in suction force can be prevented.
  • the outer sheath 80 is a tubular body that covers the outside of the second shaft 70.
  • the outer sheath 80 does not interlock with the rotation of the second shaft 70, and the outer sheath 80 does not rotate even when the second shaft 70 is rotating.
  • the outer sheath 80 may be configured to rotate together with the second shaft 7.
  • the inner diameter of the outer sheath 80 is smaller than the maximum diameter of the first taper portion 116. Therefore, the outer sheath 80 can transmit more the force that the rotating structure 110 presses the inner wall of the blood vessel, and can be cut effectively.
  • the constituent material of the outer sheath 80 is not particularly limited.
  • polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as PTFE, PEEK (polyether ether ketone), and polyimide are preferable.
  • PTFE polyethylene terephthalate
  • PEEK polyether ether ketone
  • polyimide polyimide
  • the inner diameter of the outer sheath 80 can be selected as appropriate, but is 1.2 to 2.9 mm, for example, and can be 1.9 mm as an example.
  • the outer diameter of the outer sheath 80 can be selected as appropriate, but is 1.3 to 3.0 mm, for example, and can be set to 2.0 mm as an example.
  • the first driving device 91 can rotate the first shaft 60 by applying a rotational force to the first shaft 60.
  • the first driving device 91 can drive the first shaft 60 so as to move the first shaft 60 in a direction (axial direction) parallel to the rotation axis of the first shaft 60.
  • the second driving device 92 can apply a rotational force to the second shaft 70 to rotate the second shaft 70.
  • the rotation direction of the second shaft 70 can be selected, and can be the same direction as the rotation direction of the first shaft 60 or can be the opposite direction.
  • the rotation direction of the second shaft 70 is opposite to the rotation direction of the first shaft 60, the movement of the rotary structure 110 to escape from the constriction S when the rotary structure 110 cuts the constriction S is reduced. Can do.
  • the second drive device 92 can drive the second shaft 70 so as to move the second shaft 70 in a direction parallel to the rotation axis of the second shaft 70.
  • FIG. 3 is a diagram showing a state where the medical device 10 shown in FIG. 2 is bent.
  • the second shaft 70 has a pattern cut 75 that bends upward.
  • the expansion / contraction part 61 contracts in the axial direction, and the second shaft from the rotating structure 110 via the bearing part 140.
  • a force in the proximal direction is applied to 70.
  • the second shaft 70 since the second shaft 70 has the cut line 75 that bends upward, the second shaft 70 bends upward at the curved portion 83.
  • the degree of bending of the second shaft 70 can be adjusted by adjusting the rotational speed of the first shaft 60. If the rotational speed of the first shaft 60 is increased, the second shaft 70 bends greatly, and if the rotational speed of the first shaft 60 is decreased, the second shaft 70 bends small. Further, the degree of bending of the second shaft 70 can be kept constant by keeping the rotation speed of the first shaft 60 constant. Further, the bending shape of the second shaft 70 can be defined as a desired shape by the shape of the pattern of the cuts 75.
  • the second shaft 70 it is possible to adjust the degree of bending of the second shaft 70 by moving the second shaft 70 in the axial direction by the second driving device 92. That is, by pushing the second shaft 70 in the axial direction (moving it distally), the second shaft 70 bends more and pulls the second shaft 70 in the axial direction (moving it proximally). As a result, the bending amount is reduced.
  • the first shaft 60 and the second shaft 70 can be rotated relatively, and the position in the axial direction can be moved relatively by hand operation, so that the first shaft 60 and the second shaft 70 move in the axial direction in addition to the bending force due to rotation.
  • the bending force can be increased and the bending force can be easily maintained.
  • the expansion / contraction part 61 configured to expand and contract in the axial direction by rotation is provided only in the first shaft 60, but may be provided in the second shaft 70 in addition to the first shaft 60, An expansion / contraction part may be provided only on the second shaft 70.
  • the length of the stretchable part, the winding direction of the coil, the layer structure, etc. are not particularly limited.
  • the degree of bending of the second shaft 70 can be adjusted by rotating the second shaft 70 by the second driving device 92. That is, by rotating the second shaft 70 in the tightening direction of the telescopic portion, the same action as pulling the second shaft 70 in the axial direction occurs, and the bending amount is reduced. Further, by rotating the second shaft 70 in the loosening direction of the expansion / contraction part, the same action as pushing the second shaft 70 in the axial direction occurs, and the bending amount increases.
  • the rotation direction of the first shaft 60 when cutting an object such as the constriction S in the body lumen is the tightening direction of the expansion / contraction part 61. According to this, since the strength of the expansion / contraction part 61 tightened by the rotation of the first shaft 60 is increased and is difficult to be deformed, the constricted object in a state where torque is applied so as to press the rotating structure 110 against the constricted object S. S can be cut.
  • the second shaft 70 is provided with an expansion / contraction portion, when cutting an object such as the constriction S in the living body lumen, it is preferable that the second shaft 70 is rotated in the tightening direction of the expansion / contraction portion. . With such a configuration, the tightened expansion / contraction part is difficult to be deformed, so that the constriction S can be cut in a state where torque is applied so as to press the rotating structure 110 against the constriction S. .
  • the second shaft 70 may be bent by a plurality of bending portions.
  • the second shaft 70 can be bent with a plurality of curved portions by making the cut 75 bend with a plurality of curved portions.
  • the second shaft 70 can be bent into various shapes depending on the shape of the pattern of the cuts 75.
  • the pattern of the cuts 75 may be configured so that the second shaft 70 can be easily bent in a spiral shape.
  • FIG. 4 shows an example of a pattern of the cut 75 in a developed view.
  • a curved portion that curves in an S shape can be formed. it can.
  • the vertical direction in FIG. 4 indicates the circumferential direction of the second shaft 70, and the horizontal direction indicates the axial direction.
  • a portion 76 having a larger gap than the other positions in the circumferential direction in the cut 75 constitutes an inner surface that becomes the compression side when the second shaft 70 is curved.
  • the bearing portion 141 has a structure that is not rotationally symmetric with respect to the rotation axis of the rotating structure 110.
  • a protruding portion 141 a that protrudes in the axial direction is provided on the distal end surface of the end surface of the bearing portion 141.
  • the protrusion 141a is provided only in a part in the circumferential direction (a part on the upper side in FIG. 5A).
  • the structure 110 is bent by contacting only a part of the bearing portion 141 in the circumferential direction. Specifically, when the first shaft 60 is rotated and the expansion / contraction part 61 rotates in the loosening direction, the expansion / contraction part 61 expands in the radial direction and the expansion / contraction part 61 contracts in the axial direction, so that only the protrusion 141a contacts the rotary structure 110 first. A force from the rotating structure 110 to the proximal side is applied. As a result, a force in the proximal direction is applied only to the upper side of the second shaft 70 that is easily bent downward, via the upper side of the bearing portion 141 provided with the protruding portion 141a. The shaft 70 can be smoothly bent downward. Further, by adopting such a configuration, it is possible to reduce the contact area between the rotating structure 110 and the bearing portion 141 during bending, and thus it is possible to reduce the generation of frictional heat.
  • the bearing portion 142 has such a structure, the second shaft 70 contracts in the radial direction when the first shaft 60 is rotated and the telescopic portion 61 rotates in the tightening direction, and the telescopic portion 61 is in the axial direction. Therefore, only the protrusion 142a comes into contact with the rotating structure 110 first, and a force from the rotating structure 110 to the distal side is applied. As a result, a force in the distal direction is applied to the lower side of the second shaft 70, which is originally easy to bend downward, via the lower side of the bearing portion 142, so that the second shaft 70 can be smoothly moved to the lower side. Can be bent.
  • tip side means a distal side in the rotating structure 110
  • base end side means a proximal side in the rotating structure 110
  • the rotating structure 110 includes a first annular portion 112 and a second annular portion 111 located on the tip side of the first annular portion 112. Further, the rotating structure 110 includes a constricted portion 126 between the first annular portion 112 and the second annular portion 111. The rotating structure 110 is located between the third annular portion 115 located on the proximal end side of the first annular portion 112 and between the first annular portion 112 and the third annular portion 115, and the first annular portion 112. And a small-diameter annular portion 128 having an outer diameter smaller than the outer diameter of the third annular portion 115. A bearing portion 140 is provided between the small-diameter annular portion 128 and the second shaft 70.
  • the first annular portion 112 may be the proximal end of the first tapered portion 116.
  • the second annular portion 111 may be the tip of the second tapered portion 114.
  • the constricted portion 126 has a first tapered portion 116 that decreases in diameter toward the distal end side at the distal end side of the first annular portion 112, and a diameter that decreases toward the proximal end side at the proximal end side of the second annular portion 111. 2nd taper part 114 is provided.
  • the constricted portion 126 includes a bottom portion 127 that connects the first tapered portion 116 and the second tapered portion 114.
  • the diameter of the bottom portion 127 is smaller than the diameter of the first annular portion 112 and the diameter of the second annular portion 111.
  • the diameter of the first annular portion 112 is substantially equal to the diameter of the third annular portion 115.
  • the diameter of the first annular portion 112 is larger than the diameter of the second annular portion 111.
  • the “diameter” means a diameter centered on the rotation axis X of the rotating structure 110.
  • the shape of the constricted portion 126 may be configured by the first tapered portion 116 and the second tapered portion 114 having the same maximum diameter.
  • the shape of the constricted portion 126 may be configured by the first tapered portion 116 and the second tapered portion 114 whose maximum diameter is larger than the first tapered portion 116.
  • the shape of the constricted portion 126 may be configured by the first tapered portion 116 having a maximum diameter larger than the second tapered portion 114 and the second tapered portion 114.
  • the length of the constricted portion 126 in the axial direction may be configured by the first tapered portion 116 and the second tapered portion 114 having the same axial length.
  • the length of the constricted portion 126 in the axial direction may be configured by the first tapered portion 116 and the second tapered portion 114 whose axial length is longer than that of the second tapered portion 114.
  • the length of the constricted portion 126 in the axial direction may be configured by the first tapered portion 116 and the second tapered portion 114 whose axial length is longer than that of the first tapered portion 116.
  • the rotating structure 110 includes a third taper portion 113 that is reduced in diameter toward the distal end side at the distal end side of the second annular portion 111.
  • the first taper portion 116 has a first cut portion 122 cut into a V shape in a cross section perpendicular to the axis in a part of the circumferential direction, and is a blade at the edge of the first cut portion 122.
  • a first cutting part 123 is provided. Only one first cut portion 122 may be provided in the circumferential direction, or two or more first cut portions 122 may be provided.
  • the first cut portion 122 may be asymmetric or symmetric.
  • the angle of the surface of the 1st notch part 122 opposite to the rotation direction of the rotary structure 110 is larger than the surface of the 1st notch part 122 of the 1st notch part 122 of a rotation direction.
  • abrasive grains, a grindstone, or the like may be electrodeposited on the first taper portion 116.
  • the 1st taper part 116 may become a 1st cutting part (4th cutting part).
  • the first taper portion 116 has the first cutting portion 123 of the first cut portion 122 and the first cutting portion (fourth cutting portion) on which the abrasive grains and the grindstone are electrodeposited, the first taper portion 116 first of the first cut portion 122.
  • the narrow portion can be efficiently cut by the cutting portion 123 and the first cutting portion (fourth cutting portion) on which the abrasive grains and the grindstone are electrodeposited.
  • the 1st taper part 116 does not need to have the 1st cut part 122, and may be only a 4th cutting part.
  • the abrasive grains include diamond abrasive grains.
  • the 2nd taper part 114 has the 2nd cut part 120 cut
  • a second cutting part 121 is provided. Only one second cut portion 120 may be provided in the circumferential direction, or two or more second cut portions 120 may be provided.
  • the second notch 120 may be asymmetric or symmetric.
  • the angle of the surface of the 2nd notch part 120 opposite to the rotation direction of the rotating structure 110 is larger than the surface of the 2nd notch part 120 of the 2nd notch part 120 in a rotation direction.
  • the narrowing is efficiently performed by the second cutting portion 121 of the second cut portion 120 and the cutting portion on which the abrasive grains or grindstone are electrodeposited. You can cut things.
  • the 2nd taper part 114 does not need to have the 2nd cut
  • the third taper portion 113 has a third cut portion 117 cut into a V shape in a cross section perpendicular to the axis in a part of the circumferential direction, and is a blade at the edge of the third cut portion 117.
  • a third cutting part 118 is provided. Only one third cut portion 117 may be provided in the circumferential direction, or two or more third cut portions 117 may be provided.
  • the third cut portion 117 may be asymmetric or symmetric.
  • the angle of the surface of the third cut portion 117 opposite to the rotation direction of the rotating structure 110 is larger than the surface of the third cut portion 117 in the rotation direction of the third cut portion 117.
  • the third taper portion 113 when abrasive grains, grindstones, and the like are electrodeposited on the third taper portion 113, the narrowing is efficiently performed by the third cutting portion 118 of the third cut portion 117 and the cutting portion on which the abrasive grains or grindstone are electrodeposited. You can cut things.
  • the 3rd taper part 113 does not need to have the 3rd cutting part 117, and may be only the cutting part by which the abrasive grain and the grindstone were electrodeposited.
  • the 1st cutting part 123 and the 3rd cutting part 118 are formed in the taper-shaped site
  • the 2nd cutting part 121 is formed in the taper-shaped site
  • the first cut portion 122, the second cut portion 120, and the third cut portion 117 are proportional to the axial lengths of the first taper portion 116, the second taper portion 114, and the third taper portion 113, respectively.
  • the second annular portion 111 may be formed of a shape and material that can smoothly contact the outer peripheral surface with the living tissue, and the outer peripheral surface may be the first non-cutting portion 124. Thereby, when cutting the constriction S, the risk of damaging the living tissue can be reduced.
  • the 3rd taper part 113 may provide the 2nd non-cutting part 119 in which the 3rd notch part 117 is not formed over the circumferential direction whole area
  • the 3rd cutting part 118 does not protrude outside the tangent L of the 1st non-cutting part 124 and the 2nd non-cutting part 119, it suppresses that the 3rd cutting part 118 contacts a biological tissue. And high safety can be ensured.
  • the constituent material of the rotating structure 110 is not particularly limited.
  • polyolefin such as stainless steel, Ta, Ti, Pt, Au, W, Ni, NiTi alloy, super steel (WC), high speed (HSS), polyethylene, and polypropylene.
  • Polyester such as polyamide and polyethylene terephthalate, fluorine-based polymer such as PTFE, PEEK (polyetheretherketone), polyimide, and the like can be suitably used.
  • the second shaft 70 can be bent using the expansion and contraction of the expansion / contraction part 61 without providing a pull wire for bending the second shaft 70 inside the second shaft 70. Yes. For this reason, it is possible to reduce the diameter of the second shaft 70. By reducing the diameter of the second shaft 70, it is possible to treat a biological lumen such as a thinner blood vessel.
  • the medical device 10 since the medical device 10 according to the present embodiment can move the first shaft 60 in the axial direction, it is possible to improve the accuracy when adjusting the degree of bending of the second shaft 70.
  • the rotating structure 110 includes a constricted portion 126, the constricted portion 126 includes a second tapered portion 114 whose diameter decreases toward the proximal end side, and the second tapered portion 114 includes the second cutting portion 121.
  • the second cutting part 121 in the second taper part 114 that decreases in diameter toward the proximal end in this way, the stenosis S in the living body lumen can be cut even when the rotating structure 110 is pulled. Can do.
  • the medical device 10 since a strong force can be applied to the stenosis S by pulling the rotating structure 110, the medical device 10 according to the present embodiment can cut the hard stenosis S in the living body lumen. .
  • the diameter of the bottom 127 of the constricted portion 126 is smaller than the diameter of the first annular portion 112 and the diameter of the second annular portion 111, the risk of damaging a living tissue such as a normal blood vessel is reduced. can do.
  • FIG. 7 shows a state where the stenosis S in the blood vessel is cut using the medical device 10 according to the present embodiment.
  • FIG. 7A shows a state in which the stenosis S is cut with a directionality defined in a part of the circumferential direction of the blood vessel (upward in FIG. 7A), and
  • FIG. 7B shows the blood vessel. It is a state that the constriction S is cut with the directionality defined in another part of the circumferential direction (downward in FIG. 7B).
  • the second shaft 70 is bent at two locations of the first bending portion 84 and the second bending portion 85.
  • the second shaft 70 is more distal than the first bending portion 84.
  • the narrowed object S is cut in a state where the torque is applied so as to press the rotating structure 110 against the narrowed object S. Can do.
  • the proximal end side from the first curved portion 84 of the second shaft 70 is in contact with the inner wall of the blood vessel, and the projecting portions 141a and 142a (FIG. ) And (b) are preferably provided.
  • interruption 75 of the 2nd shaft 70 is formed so that the 2nd shaft 70 may bend on the opposite side to the contact position with respect to the inner wall of the blood vessel of the 2nd shaft 70. FIG. Thereby, the constriction thing S can be cut in the state which applied the torque so that the rotary structure 110 might be pressed on the constriction thing S more effectively.
  • FIG. 8 shows a state where the narrowed object S is cut in a wide range by rotating the bent second shaft 70 and revolving the rotating structure 110.
  • the second shaft 70 is bent at two locations, the first bending portion 84 and the second bending portion 85, as in FIG.
  • the distal side of the second shaft 70 rotates more than the first bending portion 84.
  • the rotating structure 110 revolves and the constriction S can be cut over a wide range.
  • the second driving device 92 improves the cutting effect by the rotation of the rotating structure 110 by driving the rotation of the second shaft 70 such that the rotation speed of revolution is slower than the rotation speed of rotation. Can do.
  • the medical device 10 includes the tubular second shaft 70 surrounding the first shaft 60, and the second shaft 70 can be bent and rotated.
  • the rotation structure 110 can be revolved by rotating the 2nd shaft 70 in the state which bent the medical device 10, the directionality of the medical device 10 can be prescribed
  • the rotating structure 110 can be pressed against the constricted object S in a state where torque is applied, and the constricted object S can be cut.
  • a living body lumen into which a medical device is inserted is not limited to a blood vessel, and may be, for example, a vascular tube, a ureter, a bile duct, a fallopian tube, a hepatic tube, or the like.
  • This disclosure relates to medical devices.

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  • Surgical Instruments (AREA)

Abstract

L'invention porte sur un dispositif médical permettant de couper un objet dans la lumière d'un organisme vivant, et comprend : une structure rotative 110 pourvue d'une partie coupante 123 ; un premier arbre 60, couplé à la structure rotative 110, qui entraîne la rotation de la structure rotative 110 ; un second arbre tubulaire 70 qui entoure le premier arbre 60 ; et un palier 140 situé entre la structure rotative 110 et le second arbre 70. Le second arbre peut se plier dans la direction voulue. Au moins un arbre, parmi le premier arbre 60 et le second arbre 70, est pourvu d'une partie d'expansion/contraction 61 conçue de manière à se dilater et à se contracter en direction axiale suite à une rotation. Le second arbre 70 est conçu de manière à être courbé par la force de la structure rotative 110 par l'intermédiaire d'un palier 141 suite à l'expansion, ou à la contraction, de la partie d'expansion/contraction 61.
PCT/JP2017/033490 2016-09-16 2017-09-15 Dispositif médical WO2018052123A1 (fr)

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JP2016182405 2016-09-16
JP2016-182405 2016-09-16

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05184582A (ja) * 1991-07-22 1993-07-27 Dow Corning Wright Corp 着脱自在駆動装置を備えたアテローム切除装置
JP2006149988A (ja) * 2004-01-23 2006-06-15 Umi Kono 血栓除去用頭部部材とそれを使用した血栓除去用カテーテル
WO2016007652A1 (fr) * 2014-07-08 2016-01-14 Avinger, Inc. Dispositifs traversant une occlusion totale chronique à vitesse élevée

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05184582A (ja) * 1991-07-22 1993-07-27 Dow Corning Wright Corp 着脱自在駆動装置を備えたアテローム切除装置
JP2006149988A (ja) * 2004-01-23 2006-06-15 Umi Kono 血栓除去用頭部部材とそれを使用した血栓除去用カテーテル
WO2016007652A1 (fr) * 2014-07-08 2016-01-14 Avinger, Inc. Dispositifs traversant une occlusion totale chronique à vitesse élevée

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