WO2018043718A1 - Instrument médical - Google Patents

Instrument médical Download PDF

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Publication number
WO2018043718A1
WO2018043718A1 PCT/JP2017/031643 JP2017031643W WO2018043718A1 WO 2018043718 A1 WO2018043718 A1 WO 2018043718A1 JP 2017031643 W JP2017031643 W JP 2017031643W WO 2018043718 A1 WO2018043718 A1 WO 2018043718A1
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WO
WIPO (PCT)
Prior art keywords
outer sheath
sheath
distal end
housing
stent
Prior art date
Application number
PCT/JP2017/031643
Other languages
English (en)
Japanese (ja)
Inventor
静香 野
裕希 品川
Original Assignee
日本ゼオン株式会社
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 日本ゼオン株式会社 filed Critical 日本ゼオン株式会社
Priority to JP2018537570A priority Critical patent/JP7006604B2/ja
Publication of WO2018043718A1 publication Critical patent/WO2018043718A1/fr

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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
    • A61F2/962—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • the present invention relates to a medical instrument that is used by moving a member on the distal end side by an operation outside the body, such as a stent delivery device used to place a stent in the body.
  • a medical method in which a stent is placed in a stenotic site in order to ensure the patency of a body lumen such as a digestive tract or blood vessel that has been narrowed.
  • a stent is a device that is placed so that the patency of the lumen is ensured by expanding the stenotic site.
  • the stent include a balloon-expandable type and a self-expandable type.
  • a device for placing a self-expandable stent in a lumen for example, a device described in Patent Document 1 below is known.
  • the stent delivery device described in Patent Document 1 has an inner sheath (inner tube) and an outer sheath (outer tube) through which the inner sheath is slidably inserted, and is provided near the distal end of the inner sheath.
  • An operation portion (handle) provided on the proximal end side of the stent placement portion, in which the stent is placed in the vicinity of the distal end of the outer sheath and held in a state where the diameter of the stent is reduced by elastic deformation.
  • the outer sheath is slid toward the proximal end side so as to pull back the outer sheath, thereby releasing the stent from the outer sheath and expanding and releasing the stent by the self-expanding force of the stent.
  • a cylindrical shaft for reinforcing the outer sheath of the outer sheath is fixed to the outer sheath of the operation portion for sliding the outer sheath with respect to the inner sheath, and the shaft of the shaft is fixed.
  • the shaft is inserted through a through hole of a drive plate provided to be tiltable with respect to the core.
  • the drive plate is slidable with respect to the shaft when the drive plate is substantially perpendicular to the axis of the shaft, and the drive plate is engaged with the shaft when the drive plate is inclined with respect to the axis. It will be stopped.
  • This invention is made in view of such a point, and it aims at providing the medical instrument which can aim at size reduction and weight reduction of an operation part.
  • a medical device comprises: A tubular first member; A second member slidably inserted through the first member; A housing in which portions on the proximal end side of the first member and the second member are drawn into the interior, and the proximal end of the second member is fixed; A proximal end portion of the first member is fitted and fixed inside thereof, and has elasticity, and is configured by winding a wire having a substantially polygonal cross section in a coil shape so that irregularities are formed on the outside thereof. And a coil member provided so that at least a proximal end of both end portions thereof is located inside the housing.
  • the medical instrument according to the present invention further includes a slide unit that is provided in the housing and engages with a part of the unevenness of the coil member to slide the first member relative to the second member. be able to.
  • a slide unit that is provided in the housing and engages with a part of the unevenness of the coil member to slide the first member relative to the second member.
  • the coil member can be provided such that a distal end thereof is located outside the housing.
  • the coil member can reinforce part of the first member on the housing side so that it can be bent, and it is not necessary to separately provide a member for reinforcement.
  • the operation unit can be reduced in size and weight.
  • the medical instrument according to the present invention further includes an outer sheath as the first member, an inner sheath as the second member, and a stent placement portion in which a stent is placed at a distal end portion of the inner sheath.
  • the stent can be particularly suitably used as a stent delivery device that releases the stent disposed in the stent placement portion by sliding the outer sheath relative to the inner sheath.
  • FIG. 1 is a front view showing an overall configuration of a stent delivery device according to an embodiment of the present invention.
  • FIG. 2 is a side view showing a configuration of a distal end portion of the stent delivery device shown in FIG.
  • FIG. 3 is a partial cross-sectional view illustrating a configuration of a distal end portion of the stent delivery device illustrated in FIG. 1.
  • FIG. 4 is a side view showing an example of a stent applied to the stent delivery apparatus shown in FIG.
  • FIG. 5 is a cross-sectional view illustrating a configuration of the operation unit of the stent delivery device illustrated in FIG. 1 and illustrates a state in which the push button is not pressed.
  • FIG. 1 is a front view showing an overall configuration of a stent delivery device according to an embodiment of the present invention.
  • FIG. 2 is a side view showing a configuration of a distal end portion of the stent delivery device shown in FIG.
  • FIG. 3 is a partial cross-
  • FIG. 6 is a cross-sectional view showing the configuration of the operation unit of the stent delivery device shown in FIG. 1, and is a view showing a state where the push button is pushed in.
  • FIG. 7 is a cross-sectional view showing the configuration of the operation unit of the stent delivery device shown in FIG. 1, and shows a state in which the outer sheath is slid to the stroke end.
  • FIG. 8 is a partial cross-sectional view showing an enlarged main part of the operation part of the stent delivery device shown in FIG.
  • FIG. 9 is a cross-sectional view illustrating a configuration of a modified example of the operation unit of the stent delivery device illustrated in FIG. 1.
  • FIG. 10 is a partial cross-sectional view showing an enlarged main part of a modification of the operation unit of the stent delivery device shown in FIG.
  • a lumen for example, large intestine
  • a stent delivery device used to place a self-expanding stent in a closed site will be described with reference to the drawings.
  • the medical device of the present invention can be used as a stent delivery device for ensuring the patency of bile ducts, ureters, blood vessels, and other lumens as well as the patency of lumens such as digestive organs. . It can also be used as a stent delivery device for bypassing a luminal organ and other luminal organs such as the stomach and intrahepatic bile duct, duodenum and common bile duct. Furthermore, it can be used not only as a delivery device for a self-expanding stent but also as a delivery device for a tube stent having a fixed diameter.
  • the medical device of the present invention is not limited to a stent delivery device, but is a tube-shaped first member having a distal end and a proximal end, or a tube-shaped first member having a distal end and a proximal end.
  • Endoscopic treatment in which a wire-like second member is slidably inserted and the first member is slid relative to the second member toward the proximal end or the distal end. It can be widely applied to tools or other medical devices.
  • the stent delivery device 1 is connected to a proximal end side of an elongated catheter part 2 inserted into a patient's body (lumen) and the proximal end side of the catheter part 2 through a treatment instrument guide tube of an endoscope (not shown).
  • An operation part (handle) 3 for operating the catheter part 2 inside the body from the outside and a stent 5 as an indwelling object are roughly provided.
  • the distal end vicinity of the catheter part 2 containing the stent 5 may be cursed according to the shape of the site
  • the catheter unit 2 includes an inner sheath (inner tube) 21 having a distal end and a proximal end, and an outer sheath (outer tube) 22 having a distal end and a proximal end.
  • a contrast marker (not shown) may be attached.
  • the contrast marker is detected by fluoroscopy and becomes a label in the body.
  • the contrast marker is formed of a metal material such as gold, platinum, or tungsten, or a polymer blended with barium sulfate or bismuth oxide. .
  • the inner sheath 21 is made of an elongated tube having flexibility, and a guide wire 4 used as a guide for inserting the catheter portion 2 into a patient's body is inserted into the inner sheath 21. After the guide wire 4 is inserted into the body to secure a path between the outside of the body and the inside of the body, the catheter portion 2 is pushed (advanced) along the guide wire 4 so that the distal end side of the catheter portion 2 is positioned within the body. Can be inserted into the site.
  • the outer diameter of the inner sheath 21 is about 0.5 to 4.0 mm.
  • a distal tip 24 is attached to the distal end of the inner sheath 21 so as to become thinner toward the distal end (distal end).
  • the tip 24 has an opening 24 a communicating with the distal end of the lumen of the inner sheath 21 along the central axis, and the proximal end thereof is the distal end of the lumen of the outer sheath 22.
  • the small-diameter portion 24b has an outer diameter that can be inserted into the portion (see FIGS. 2 and 3).
  • the distal tip 24 plays a role of reducing insertion resistance of the catheter part 2 and facilitating insertion into the body, such as polyamide, polyamide elastomer, polyurethane, fluorine resin such as polytetrafluoroethylene, and polyethylene. It can be formed from a polyolefin resin or the like.
  • a fixing ring 25 is integrally fixed in the vicinity of the distal end of the inner sheath 21, and this fixing ring 25 is for defining the position of the proximal end of the stent 5.
  • the distal end side portion is a stent placement portion. In the stent placement portion, the stent 5 is placed so as to cover the inner sheath 21.
  • the outer sheath 22 is made of an elongated tube having flexibility, has an inner diameter slightly larger than the outer diameter of the inner sheath 21, and the inner sheath 21 is slidably inserted in the inner sheath 21.
  • the outer diameter of the outer sheath 22 is about 0.5 to 4.5 mm, and the outer diameter is about 1.0 to 5.0 mm.
  • the outer sheath 22 is slidable (relatively moved) in the axial direction with respect to the inner sheath 21 by operating the operation unit 3.
  • Examples of materials for the inner sheath 21 and the outer sheath 22 include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyurethane, ethylene-vinyl acetate copolymer, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polyamide, and polyether polyamide.
  • outer sheath 22 may be provided with a flexible elongate tube through which the outer sheath 22 is slidably inserted, the outer tube is not provided in the present embodiment.
  • the stent 5 is a self-expanding covered stent that expands by its own elastic force from a state of being contracted and contracted by elastic deformation.
  • a cylindrical bare stent formed by a frame is used. 51 and a covering film portion 52 that covers the outer periphery of the bare stent 51.
  • the bare stent 51 is formed of a superelastic metal such as a nickel titanium alloy or a cobalt chromium alloy, a shape memory metal, or the like.
  • the surface of the bare stent 51 is covered with a coating film spreading so as to fill between adjacent frames, and the outer periphery of the bare stent 51 covered with the coating film is covered with a covering film portion 52 such as a polymer film. Yes.
  • the total length and diameter of the stent 5 are determined according to the application, but the total length is about 30 to 200 mm, and the outer diameter when expanded is about ⁇ 2 to ⁇ 20 mm.
  • the outer diameter of the stent 5 when the diameter is reduced is about a fraction of the outer diameter when the stent 5 is expanded.
  • the stent 5 is described as one of the constituent members of the stent delivery device 1, but the stent 5 can be replaced as a separate member from the stent delivery device 1.
  • the guide wire 4 is inserted into the lumen of the inner sheath 21 when the stent delivery device 1 is inserted into the body lumen, and its distal end is the distal end of the distal tip 24 of the inner sheath 21. Projecting from the opening 24a (see FIGS. 2 and 3), and the proximal end thereof is exposed to the outside through the opening of the protruding portion 21a at the proximal end of the inner sheath 21 disposed through the operation portion 3. To be arranged.
  • the operation part 3 has a handle that is a means for the operator to grip the stent 5 and perform a release operation of the stent 5.
  • the housing 31 constituting the handle has a substantially linear lower side 31a so that the index finger, middle finger, ring finger and little finger (or one or more of these) can be placed when gripped by the operator's hand, It has an upper side portion 31b having a concave portion having a loose arcuate shape so that a portion of the base of the thumb and a portion near the base of the thumb of the palm can be arranged.
  • the housing 31 has a sheath accommodating portion 32 that defines a substantially cylindrical space into which the proximal end sides of the inner sheath 21 and the outer sheath 22 are drawn.
  • the distal end of the sheath housing portion 32 is an opening 32a for drawing these sheaths 21 and 22, and the proximal end of the sheath housing portion 32 is brought into contact with the proximal end of the outer sheath 22, and the outer
  • the sheath 22 is closed by a bottom surface 32b that defines a stroke end when the sheath 22 is slid.
  • a through hole is formed in the central portion of the bottom surface 32b, and the proximal end of the inner sheath 21 is inserted into the through hole, and is fixed to the outer peripheral surface thereof by adhesion or the like.
  • a projection 21 a having a through hole communicating with the through hole is provided at the proximal end of the housing 31.
  • a push button (pressing member) 33 extends in the portion of the outer sheath 22 in the housing 31 (the axial direction of the sheath housing portion 32). Is slidably held in a direction A1 intersecting at a predetermined angle ⁇ 1. That is, the housing 31 is provided with a button accommodating portion 34 that defines a substantially cylindrical space.
  • the button accommodating portion 34 has an axial direction A1 in the axial direction (outer outer) of the sheath accommodating portion 32.
  • the sheath 22 is formed so as to substantially coincide with the direction intersecting with the predetermined angle ⁇ 1.
  • a substantially cylindrical push button 33 is inserted into the opening side of the button accommodating portion 34, and the push button 33 is slidably held along the axial direction of the button accommodating portion 34.
  • a part of the push button 33 is provided with a mechanism for preventing the push button 33 from coming out of the button accommodating portion 34 by engaging with a part of the button accommodating portion 34.
  • a spring support portion 34 a is provided at an intermediate portion of the button accommodating portion 34, and a coil spring (biasing member) 35 is interposed between one surface of the spring support portion 34 a and the front end surface of the push button 33.
  • the push button 33 If the push on the push button 33 is released, the push button 33 returns to the original first position by the biasing force of the coil spring 35.
  • the second position of the push button 33 is defined by the position of the spring support portion 34a and the dimension in the longitudinal direction when the coil spring 35 is compressed.
  • the push button 33 is arranged by placing the abdomen of the index finger, middle finger, ring finger and little finger (or one or more of them) on the lower side 31a by the operator's hand, and the base of the thumb and the base of the thumb of the palm. In the state where the vicinity portion of the thumb is placed and gripped on the upper side portion 31b, the thumb can be pushed or released by the belly of the tip of the thumb (the portion ahead of the first joint) by bending and extending the thumb. Yes.
  • the position of the end surface on the distal end side of the push button 33 (first position) and the amount of push (the first position and the first position) Dimension between two positions) is set.
  • the push-in amount (stroke length) of the push button 33 is set to an optimal value in relation to the ergonomic viewpoint described above and the feed amount of the coil member 22a (outer sheath 22) by one push of the push button 33.
  • the axial center direction (slide direction of the push button 33) A1 of the button housing portion 34 is the sheath housing. With respect to the axial direction of the part 32, it is set so as to be inclined and inclined toward the distal end side. Predetermined between the shaft core of the button housing portion 34 (the pushing direction A1 of the push button 33) and the shaft core of the sheath housing portion 32 (the extending direction of the outer sheath 22 in the housing 31 or the extending direction of the lower side portion 31a).
  • the angle ⁇ 1 can be set in a range larger than 0 ° and smaller than 90 °. The optimum value is set in relation to the ergonomic viewpoint and the configuration of the coil member 22a described later.
  • the leaf spring 33a can be obtained by setting it to about ⁇ 1 ⁇ 30 ° ( ⁇ 2 / 2).
  • the tip of the crossing intersects the surface on the distal end side of the screw thread (convex portion) of the coil member 22a at approximately 90 °, so that the most reliable engagement can be obtained.
  • the predetermined angle ⁇ 1 is in the range of 15 ° to 60 °.
  • the apex angle ⁇ 2 of the thread is not particularly limited.
  • it is preferable that the angle ⁇ 2a of the thread surface on the distal end side with respect to the surface A2 perpendicular to the axial direction of the sheath housing portion 32 is substantially the same as the predetermined angle ⁇ 1.
  • the distal end side (the back side opposite to the opening side) of the button accommodating portion 34 is communicated with a part (side surface) of the sheath accommodating portion 32 through the connection space 36.
  • a proximal end portion of a leaf spring (plate-like elastic member) 33 a is fixed to the distal end of the push button 33.
  • the distal end side of the leaf spring 33a passes through the connection space 36 and the distal end slightly protrudes into the sheath housing portion 32 in a state where the push button 33 is set to the first position (the state shown in FIG. 5).
  • a coil member 22 a that forms a plurality of convex portions (or concave portions) on the surface thereof is attached to a part of the outer sheath 22 on the proximal end side.
  • the coil member 22a is configured by winding a wire made of elastic metal or the like having a substantially polygonal cross section into a coil shape, and the outer end of the outer sheath 22 is inserted into the outer sheath 22 so that the outer It is fixed to the sheath 22.
  • the coil member 22a it is possible to use a coil in which a thread is formed as a convex portion on the surface side by winding a wire material having a substantially triangular cross section in a coil shape.
  • a wire rod having a substantially rhombus-shaped cross section is wound in a coil shape so that threads are formed on both the surface side and the inner surface side thereof (such as a so-called insert screw). May be used.
  • the concave / convex inner peripheral surface of the coil member 22a in which the thread is formed on both the front surface side and the inner surface side thereof is fixed by biting into the outer peripheral surface of the outer sheath 22 so as not to move relative to each other in the axial direction. Fixed.
  • the tip of the leaf spring 33a is engaged with one distal end surface of the thread of the coil member 22a attached to the outer sheath 22, and the outer sheath 22 is slid to the proximal end side by a certain amount corresponding to the stroke length of the push button 33 with respect to the inner sheath 21 (see the leaf spring 33a shown by the one-dot chain line in FIG. 8).
  • the push button 33 When the push on the push button 33 is released, the push button 33 returns to the original first position by the urging force of the coil spring 35, and the tip of the leaf spring 33a is engaged with the coil member 22a attached to the outer sheath 22 accordingly. Without doing so, the leaf spring 33a returns to its original position (see the leaf spring 33a shown by the solid line in FIG. 8).
  • the outer sheath 22 By repeatedly pressing and releasing the push button 33, the outer sheath 22 can be slid to the proximal end side by a predetermined amount with respect to the inner sheath 21.
  • the feed amount of the coil member 22a (outer sheath 22) by one push of the push button 33 is not particularly limited, but is, for example, 2.5 mm to 10 mm (for example, 2.5 mm, 5 mm, 7.5 mm, or 10 mm).
  • the stroke length of the push button 33 is a value corresponding to this.
  • the apex angle ⁇ 2 of the thread (convex portion) of the coil member 22a can be 60 ° as in the case of general screws, but may be other than 60 °. Further, the screw thread of the coil member 22a may have a flank angle ⁇ 2a on the distal end side different from a flank angle ⁇ 2b on the proximal end side.
  • the apex angle (or flank angle) of the thread of the coil member 22a is such that when the push button 33 is pressed and pushed, the tip of the leaf spring 33a is the surface on the distal end side of one of the threads of the coil member 22a. And the outer sheath 22 may be slid to the proximal end side.
  • the apex angle (or flank angle) of the thread of the coil member 22a is related to the thread of the coil spring 22a near the tip when the push button 33 is released.
  • the push button 33 is set so as to smoothly return to the original position (first position) without matching.
  • the proximal end portion of the outer sheath 22 is inserted in a state where the coil member 22a is expanded so that its inner diameter is slightly expanded, and the coil By reducing the diameter by the restoring force of the member 22a, the member 22a can be fixed.
  • the screw thread By arranging the screw thread on the inner surface side of the coil member 22a, the coil member 22a can be reliably fixed to the outer sheath 22 without using an adhesive or the like. However, it may be bonded and fixed with an adhesive or the like.
  • the dimension in the longitudinal direction of the coil member 22a is set to a dimension larger than the stroke length (sliding length of the outer sheath 22 with respect to the inner sheath 21) necessary for releasing the stent 5 disposed in the stent placement portion.
  • the position of the proximal end of the coil member 22a is a state in which the outer sheath 22 is pulled out by the maximum amount (that is, a state where the distal end portion of the outer sheath 22 is disposed so as to cover the stent 5 disposed in the stent placement portion). ) At the proximal end side of the portion where the tip of the leaf spring 33a is located in a state where no external force acts on the push button 33.
  • the push button 33 is placed in a state in which the outer sheath 22 is retracted in the maximum amount (the proximal end of the outer sheath 22 is in contact with the bottom surface 32b of the sheath housing portion 32). It is set on the distal end side with respect to the portion where the tip of the leaf spring 33a is located in a state where no external force is applied.
  • the position of the distal end of the coil member 22a is in a state in which the outer sheath 22 is pulled in a maximum amount (a state where the proximal end of the outer sheath 22 is in contact with the bottom surface 32b of the sheath housing portion 32). It is set so as to protrude from the opening 32a of the sheath housing portion 32 to the distal end side by a predetermined dimension.
  • the predetermined dimension may be about 30 to 220 mm.
  • the housing 31 (the sheath accommodating portion 32).
  • the outer sheath 22 is protruded from the opening of the sheath housing portion 32 to the distal end side by a predetermined dimension in the present embodiment. A part of the proximal end side of the base plate is reinforced.
  • the coil member 22a in the present embodiment is configured by winding a wire made of an elastic metal into a coil shape, and thus has flexibility, and is disposed around the outer sheath 22 so that the outer sheath 22 is arranged. Even when a local force that bends to the housing 31 side portion of the outer sheath 22 is applied, the outer sheath 22 can be uniformly bent and reinforced so as to prevent kinking of the outer sheath 22.
  • the portion disposed inside the housing 31 of the coil member 22a in the present embodiment provides a function for more effectively engaging the tip of the leaf spring 33a when the outer sheath 22 is slid, It provides a function as a reinforcing member that protects against damage (collapse or the like) to the outer sheath 22 due to engagement with the tip of the leaf spring 33a.
  • the portion (and the vicinity thereof) disposed on the outer side (distal end side) of the housing 31 of the coil member 22a is protected from local bending or the like in the portion of the outer sheath 22 on the housing 31 side.
  • the function as a reinforcing member is provided.
  • the release switch 37 is provided at the portion near the distal end on the lower side portion 31a side of the housing 31 in the extending direction of the portion of the outer sheath 22 existing in the housing 31 (axial center direction of the sheath housing portion 32). Is slidably held in a direction substantially parallel to.
  • the housing 31 has a switch housing portion 38 that defines a substantially rectangular parallelepiped space.
  • the switch housing portion 38 has a longitudinal direction in the axial direction of the sheath housing portion 32 (the outer sheath 22 of the outer sheath 22). It is formed in a direction substantially parallel to the extending direction).
  • a substantially rectangular parallelepiped release switch 37 is housed in the switch housing portion 38 so as to be slidable along the longitudinal direction, and an operation projection 37 a formed integrally with the release switch 37 is a lower side portion of the switch housing portion 38. It arrange
  • the stomach of the index finger, middle finger, ring finger and little finger (or one or more of them) is placed on the lower side 31a, and the base part of the thumb and the part near the base of the thumb of the palm are the upper side
  • the operation protrusion 37a is pressed toward the proximal end side or the distal end side along the longitudinal direction at the distal end portion of the index finger with the housing 31 gripped as described above,
  • the release switch 37 can be slid.
  • the proximal end side of the switch housing portion 38 is communicated with a part (side surface) of the sheath housing portion 32 through the connection space 39.
  • a base end portion of a leaf spring 37b made of an elastic metal or the like that extends obliquely in the sliding direction of the release switch 37 is fixed.
  • the tip of the leaf spring 37b passes through the connection space 39, and one distal end of one thread of the coil member 22a. It arrange
  • the distal end of the leaf spring 37b In the state where the release switch 37 is set to the fixed position, the distal end of the leaf spring 37b is engaged with the surface on the distal end side of the thread of the coil member 22a, so that the coil member 22a (outer sheath 22) is distant. Regulates sliding toward the distal end.
  • the distal end portion of the leaf spring 37b When the coil member 22a (outer sheath 22) is slid to the proximal end side, the distal end portion of the leaf spring 37b is elastically deformed along the shape of the thread of the coil member 22a and escapes, so the coil member 22a.
  • the sliding of the (outer sheath 22) toward the proximal end side is not restricted.
  • the release switch 37 When the release switch 37 is slid to the distal end side and set to the release position, the base end side of the leaf spring 37b is elastically deformed with a part of the housing 31 as a fulcrum, and the coil member 22a of the leaf spring 37b at the tip thereof. Is disengaged from the thread (see the leaf spring 37b indicated by the one-dot chain line in FIG. 8). Therefore, when the release switch 37 is set to the release position, the sliding of the coil member 22a (outer sheath 22) to the distal end side is not restricted. If necessary, the outer sheath 22 is moved to the distal end side. It is possible to slide it.
  • the release switch 37 by sliding the release switch 37, the engagement of the leaf spring 37b with the thread (projection) of the coil member 22a can be released, and the outer sheath 22 can be slid to the distal end side.
  • the leaf spring 37b is fixed without fixing the release switch 37 or the like, and the release switch 37 is fixed to the proximal end side. You may fix to the housing 31 with the same attitude
  • the distal end of the outer sheath 22 reaches the tip tip 24 as shown in FIGS.
  • the small diameter portion 24b of the tip tip 24 is inserted into the distal end portion of the cavity, and in this state, the stent 5 disposed in the stent placement portion of the inner sheath 21 is held in a reduced state. It has become a state.
  • the outer sheath 22 is slid toward the proximal end side with respect to the inner sheath 21, and the stent 5 is moved to the distal side of the outer sheath 22. It is pushed out relatively from the end and released (expanded diameter) by self-expanding force.
  • the push button 33, the button accommodating portion 34, the coil spring 35, the leaf spring 33a, the connection space 36, and the like, and the coil member 22a attached to the outer sheath 22 are provided, and the push button is provided.
  • the outer sheath 22 is slid with respect to the inner sheath 21 by repeating the pressing and release to the inner sheath 21, and the configuration is simpler than that of the prior art, and the size and weight of the operation unit are reduced. Can be planned.
  • the shape of the housing 31, the pressing position of the push button 33, the pressing direction, the stroke length, and the like are optimized ergonomically. It is basically possible to operate with one hand while gripping in a shape, and operability is good.
  • the leaf spring 37b whose tip is engaged with the surface on the distal end side of the thread (convex portion) of the coil member 22a is provided. Retrograde movement (sliding toward the distal end side) can be effectively prevented.
  • the leaf spring 37b is attached to the release switch 37, and engages the distal end side surface of the thread (convex portion) of the coil member 22a at the tip of the leaf spring 37b as necessary. This is convenient.
  • a push mechanism (push button 33, button housing portion 34, coil spring 35, leaf spring 33a, connection space 36, etc.) is provided and pressed against the push button 33 provided in the housing 31.
  • the outer sheath 22 is slid through the coil member 22a by repeating the pressing and release.
  • the mechanism (sliding means) for sliding the outer sheath 22 by engaging with a part of the thread (convex portion) of the coil member 22a is not limited to the push mechanism.
  • a gear member is rotatably supported by the housing 31, and a part of the gear member is exposed to the outside of the housing 31, and a part of the gear member is engaged with the coil member 22a.
  • the exposed part of the gear member may be configured such that the operator can rotate with, for example, the thumb.
  • a member (claw or female screw) meshing with the thread of the coil member 22a is fixed to the housing 31, the outer sheath 22 is rotated, You may use what made the outer sheath 22 slide on the principle of a ball screw.
  • the sliding direction of the outer sheath 22 relative to the inner sheath 21 when the stent 5 is released is from the distal end side to the proximal end side.
  • the direction is heading.
  • the tube stent is pushed out at the distal end of the outer sheath 22 and released, so that the outer sheath 22 slides with respect to the inner sheath 21.
  • the direction is a direction from the proximal end side toward the distal end side.
  • the tips of the leaf spring 33a and the leaf spring 37b are arranged so as to engage with the surface on the proximal end side of the thread (convex portion) of the coil member 22a, and a slide such as a push mechanism is provided. What is necessary is just to comprise so that the coil member 22a (outer sheath 22) may be extruded by the means to the distal end side.
  • the leaf spring 33a fixed to the tip of the push button 33 has a substantially linear shape extending in the direction along the moving direction of the push button 33 in a state where no external force is applied. This is because when the push button 33 is pressed and pushed in, strong engagement is obtained with respect to the thread of the coil member 22a, and the pressing force of the push button 33 is efficiently transmitted to the coil member 22a. On the contrary, when the push button 33 is released, the push button 33 can be smoothly returned as non-engaged or weakly engaged.
  • the thread of the coil member 22a of the leaf spring 33a is applied. Since the engagement with the outer sheath 22 is weak, there is a possibility that the outer sheath 22 (coil member 22a) may move in the direction in which it is retracted. In order to cope with this, it may be configured as shown in FIGS. That is, the leaf spring 33a ′ in FIGS. 9 and 10 is bent (or bent) in the middle thereof, and the tip of the leaf spring 33a ′ (the portion engaged with the thread of the coil member 22a) is a coil. It is made to be substantially perpendicular to the axis of the member 22a.
  • the release switch 37 (37a) is not provided, and the leaf spring 37b is directly fixed to the housing 31.
  • the shapes (structures) of the housing 31 and the push button 33 are illustrated as different from those shown in FIGS. 5 to 8, but are functionally similar.
  • the same reference numerals as those shown are given, and the description thereof is omitted.
  • substantially the same members or parts as those shown in FIGS. 5 to 8 are denoted by the same reference numerals as those shown in FIGS. 5 to 8, and the description thereof is omitted.
  • Stent delivery device (medical instrument) 2 ... catheter part 21 ... inner sheath (second member) 22. Outer sheath (first member) 22a ... Coil member 24 ... Tip 3 ... Operation part 31 ... Housing 32 ... Sheath accommodating part 33 ... Push button (pressing member) 33a, 33a '... leaf spring (elastic member) 34 ... Button housing part 35 ... Coil spring 36 ... Connection space 37 ... Release switch 37b ... Leaf spring 4 ... Guide wire 5 ... Stent

Abstract

[Problème] Fournir un instrument médical dans lequel une partie opérationnelle peut être réduite en termes de taille et de poids. [Solution] Selon la présente invention, une gaine externe 22, à travers laquelle passe une gaine interne 21, est introduite dans un boîtier 31 d'une partie opérationnelle 3. Un élément de bobine 22a, à l'intérieur de laquelle la gaine externe 22 est montée et fixée, et qui est configuré de sorte qu'un fil élastique ayant une section transversale sensiblement polygonale soit enroulé autour de l'extérieur de celui-ci de sorte que des irrégularités soient formées sur celui-ci, est disposé à l'extrémité proximale de la gaine externe 22 de façon à s'étendre sur l'intérieur et l'extérieur du boîtier 31.
PCT/JP2017/031643 2016-09-02 2017-09-01 Instrument médical WO2018043718A1 (fr)

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JP2018537570A JP7006604B2 (ja) 2016-09-02 2017-09-01 医療用器具

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JP2016172175 2016-09-02
JP2016-172175 2016-09-02

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WO2018043718A1 true WO2018043718A1 (fr) 2018-03-08

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JP2001509398A (ja) * 1997-06-30 2001-07-24 イーバ コーポレイション 動脈瘤の外科的修復のための方法および装置
JP2015535195A (ja) * 2012-11-08 2015-12-10 ディスタル・アクセス・エルエルシー 医療デバイスを回転させるための装置、当該装置を含むシステム、および、関連する方法
JP2016501680A (ja) * 2012-12-31 2016-01-21 ヴォルカノ コーポレイションＶｏｌｃａｎｏ Ｃｏｒｐｏｒａｔｉｏｎ センサ付きガイドワイヤ用の皮下管内壁センサマウント
JP2016501674A (ja) * 2012-12-28 2016-01-21 ヴォルカノ コーポレイションＶｏｌｃａｎｏ Ｃｏｒｐｏｒａｔｉｏｎ 関連するデバイスを備えた、血管内デバイスに保存された情報および／または無線通信機能を有する血管内デバイス、システム、ならびに方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0623057A (ja) * 1991-01-28 1994-02-01 Advanced Cardiovascular Syst Inc ステント送入システム
JP2001509398A (ja) * 1997-06-30 2001-07-24 イーバ コーポレイション 動脈瘤の外科的修復のための方法および装置
JP2015535195A (ja) * 2012-11-08 2015-12-10 ディスタル・アクセス・エルエルシー 医療デバイスを回転させるための装置、当該装置を含むシステム、および、関連する方法
JP2016501674A (ja) * 2012-12-28 2016-01-21 ヴォルカノ コーポレイションＶｏｌｃａｎｏ Ｃｏｒｐｏｒａｔｉｏｎ 関連するデバイスを備えた、血管内デバイスに保存された情報および／または無線通信機能を有する血管内デバイス、システム、ならびに方法
JP2016501680A (ja) * 2012-12-31 2016-01-21 ヴォルカノ コーポレイションＶｏｌｃａｎｏ Ｃｏｒｐｏｒａｔｉｏｎ センサ付きガイドワイヤ用の皮下管内壁センサマウント

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