WO2023123954A1 - 可调弯鞘管、医疗器械输送系统及制备可调弯鞘管的方法 - Google Patents

可调弯鞘管、医疗器械输送系统及制备可调弯鞘管的方法 Download PDF

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Publication number
WO2023123954A1
WO2023123954A1 PCT/CN2022/102655 CN2022102655W WO2023123954A1 WO 2023123954 A1 WO2023123954 A1 WO 2023123954A1 CN 2022102655 W CN2022102655 W CN 2022102655W WO 2023123954 A1 WO2023123954 A1 WO 2023123954A1
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WO
WIPO (PCT)
Prior art keywords
sleeve
tube
section
adjustable
bending
Prior art date
Application number
PCT/CN2022/102655
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English (en)
French (fr)
Inventor
王泽涛
罗瑞聪
江巍
张庭超
Original Assignee
杭州德晋医疗科技有限公司
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Publication of WO2023123954A1 publication Critical patent/WO2023123954A1/zh

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    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present disclosure relates to the field of medical devices, and more particularly to an adjustable curved sheath, a medical device delivery system including the adjustable curved sheath and a method for preparing the adjustable curved sheath.
  • the mitral valve is a one-way valve between the left atrium and the left ventricle of the heart.
  • a normal mitral valve controls the one-way flow of blood from the left atrium to the left ventricle.
  • mitral valve regurgitation In recent years, interventional therapy has been widely used in the clinical treatment of heart diseases such as mitral valve regurgitation. Specifically, it refers to delivering drugs or devices to the diseased part through a special catheter or sheath to repair or replace the diseased mitral valve.
  • a matching catheter and an adjustable curved sheath are usually used, and by adjusting the distal angle of the adjustable curved sheath, the The catheter worn in the adjustable curved sheath points to the lesion, so that the drug or device can be delivered smoothly.
  • the present disclosure provides an adjustable bending sheath, including a tubular body and a traction mechanism; wherein, the tubular body includes: a bending adjustment section at a distal end, a main body section at a proximal end, and a transition section connecting the bending adjustment section and the main body section,
  • the bending section includes a first pipe, a second pipe passing through the first pipe, and a first sleeve and a second sleeve disposed in the radial gap between the first pipe and the second pipe, at least part of the traction mechanism passes through It is arranged in the radial gap between the first sleeve and the second sleeve.
  • both the first sleeve and the second sleeve are of mesh structure, and the first sleeve passes through the second sleeve.
  • both the first sleeve and the second sleeve are formed by braiding wires; the diameter of the braiding wires of the first sleeve is larger than the diameter of the braiding wires of the second sleeve The wire diameter, the braiding pitch of the first sleeve is smaller than the braiding pitch of the second sleeve.
  • the diameter of the braided wire of the first sleeve is 0.05 to 0.25 mm, and the braiding pitch is 25 to 50 PPI; the wire diameter of the braided wire of the second sleeve is 0.05 to 0.12 mm , the weaving pitch is 5 to 15PPI.
  • the transition section includes a first tube, the second tube passing through the first tube, and a radial gap between the first tube and the second tube
  • the transition sleeve, at least part of the traction mechanism is passed through the radial gap between the transition sleeve and the second pipe.
  • the traction mechanism includes an anchor ring and a pull wire; the anchor ring is fixed at the distal end of the bending section and is located In the radial gap of the pipe, at least part of the pulling wire is folded in half and passed through the radial gap between the first sleeve and the second sleeve, and the bending point where the pulling wire is folded in half is in line with the Anchor ring connection.
  • the pulling wire passes through the radial gap between the first sleeve and the second sleeve of the bending adjustment section, the transition section and part of the main body sequentially in the axial direction segment, and pass through the tubular body from the main body segment, and freely dissociate outside the tubular body.
  • the traction mechanism further includes a protective tube sheathed on the traction wire.
  • the anchoring ring includes an annular body having a radial protrusion, and the pull wire is attached to the anchoring ring after the protrusion is folded in half.
  • the anchor ring includes an annular body including at least one axial groove provided in an outer peripheral surface thereof.
  • the anchoring ring includes an annular body and a connecting portion; the connecting portion stands radially on the outer peripheral surface of the annular body, and the connecting portion is provided with two radial through holes. holes, and the connecting part includes an arc-shaped groove on its outer peripheral surface between the two radial through holes; Two through holes.
  • the anchoring ring includes an annular body, and at least one annular groove coaxial with the annular body is provided on the annular body, and at least one annular groove respectively communicated with the annular groove Two through holes.
  • the annular groove is provided on the distal face or the peripheral surface of the annular body.
  • the adjustable bend sheath further includes at least one visualization component configured to display the position of the bend segment.
  • the number of the developing parts is two, wherein one of the developing parts is arranged at a position close to the anchor ring, and the other of the developing parts is arranged between the bending section and the The junction of the transition section.
  • the present disclosure also provides a medical device delivery system including the above-mentioned adjustable curved sheath, and further includes a catheter movably threaded in the adjustable curved sheath.
  • the present disclosure also provides a method for preparing the above-mentioned adjustable curved sheath, including:
  • a layer of braided mesh is placed on the outside of the fixed protective tube to form the first sleeve;
  • a braided net is put on the outer side of the protective tube to form the second sleeve, and the braided net can at least cover the outer side of the bending section;
  • the support of the bending section can also improve the situation that the inner wall of the bending section of the adjustable bending sheath is prone to unevenness, which leads to interference between instruments.
  • the pulling force of the pulling wire acts directly on the braided mesh, reducing the impact on the inner membrane (that is, the inner wall), so that the inner wall is no longer prone to unevenness, which greatly improves the smoothness of the instrument, greatly reduces the difficulty of adjustment, and reduces the need for surgery.
  • the operation time is reduced, and the risk of surgery is reduced.
  • Fig. 1 is a schematic structural diagram of an adjustable curved sheath according to some embodiments of the present disclosure
  • Fig. 2 is a sectional view perpendicular to the axial direction of the bending section in Fig. 1;
  • Fig. 3 is an axial sectional view of the pipe body in Fig. 1;
  • Fig. 4 is a partially enlarged view of the adjustable bending sheath in Fig. 1 in the bending section;
  • Fig. 5 is a sectional view perpendicular to the axial direction of the transition section in Fig. 1;
  • Fig. 6 is a schematic structural view of the traction mechanism in Fig. 1;
  • Fig. 7 is a structural schematic diagram of the anchor ring in Fig. 6;
  • Fig. 8 is a structural schematic diagram of an anchoring ring of an adjustable curved sheath according to some embodiments of the present disclosure
  • FIG. 9 is a schematic structural diagram of a traction mechanism for an adjustable curved sheath according to some embodiments of the present disclosure.
  • Fig. 10 is a schematic structural diagram of the anchor ring in Fig. 9;
  • Fig. 11 is a schematic structural diagram of a traction mechanism of an adjustable curved sheath according to some embodiments of the present disclosure
  • Fig. 12 is a schematic structural diagram of the anchor ring in Fig. 11;
  • Fig. 13 is a schematic structural diagram of a traction mechanism of an adjustable curved sheath according to some embodiments of the present disclosure.
  • the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator;
  • the axial direction refers to the end parallel to the medical device. The direction of the line connecting the center of the distal end and the center of the proximal end of the instrument.
  • the adjustable bendable sheath 1 includes a tubular body 11 and a traction mechanism 12; wherein, the tubular body 11 includes: a bending section 111 located at the distal end; The main body section 112 at the end, and the transition section 113 connecting the bending adjustment section 111 and the main body section 112, the bending adjustment section 111 includes a first tube 1111, a second tube 1112 coaxially passing through the first tube 1111, and a second tube 1112 located in the first tube 1111.
  • a double-layer sleeve is arranged in the radial gap 1110 between the first tube 1111 and the second tube 1112 of the bending section 111 : the first sleeve 1113 and the second sleeve 1114, and at least part of the traction mechanism 12 passes through the radial gap 1110 between the first sleeve 1113 and the second sleeve 1114, this structure can greatly improve the bending section 111 support, and improve the inner wall of the bending section of the sheath, which is prone to unevenness and cause interference between instruments, because in the prior art sheath tube bending process, the bending force mainly acts on the bending section, if The drawing wire of the bending section is placed on the inner side of the braided mesh, and there is only a relatively thin PTFE inner membrane inside the drawing wire (that is, the second tube 1112).
  • the bending section is controlled by the movement of the drawing wire.
  • the inner membrane On the inner membrane, the inner membrane is easily deformed to form a bumpy structure.
  • the pulling wire of the adjustment section is placed on the outside of the braided mesh, and the pulling force of the pulling wire acts directly on the braided mesh during bending adjustment, which has little influence on the inner membrane, so that the inner membrane is no longer prone to unevenness, thus making the inner membrane less prone to unevenness.
  • the smoothness of the instrument is greatly improved, the difficulty of adjustment is greatly reduced, the operating time of the operation is reduced, and the risk of the operation is reduced.
  • the tubular body 11 includes in sequence from the distal end to the proximal end along the axial direction A: a bending section 111, a transition section 113, and a main body section 112.
  • the tubular body 11 can be integrally formed, or assembled in sections. and connect.
  • the bending section 111 is arranged on the part of the tube body 11 near the distal end of the adjustable bending sheath 1, and is used to realize the bending of the sheath, as shown in Fig. 1 , the bent section 111'.
  • the length of the bending section 111 is about 40 to 60 mm, and the bending angle is adjustable, so that the adjustable bending sheath tube 1 can adapt to the complex blood vessel path of the human body.
  • the bending section 111 includes a first tube 1111 and a second tube 1112 both arranged along the axial direction A, the diameter of the first tube 1111 is larger than that of the second tube 1112, and the second tube 1112 is coaxial Set in the first tube 1111 , thus forming a radial gap 1110 between the inner wall of the first tube 1111 and the outer wall of the second tube 1112 .
  • the first tube 1111 can be a tube structure made of polymer elastomer, which is a thermoplastic material, usually: PA (nylon), PC (polycarbonate), TPU (thermoplastic polyurethane elastomer), PE ( Polyethylene), PTFE (polytetrafluoroethylene), Pebax (block polyetheramide), etc.
  • PA polymer elastomer
  • PC polycarbonate
  • TPU thermoplastic polyurethane elastomer
  • PE Polyethylene
  • PTFE polytetrafluoroethylene
  • Pebax block polyetheramide
  • the second tube 1112 can be a tube structure made of PTFE (polytetrafluoroethylene), such as a PTFE (polytetrafluoroethylene) tube with a wall thickness of 0.05 to 0.30 mm. In a specific implementation manner of the embodiment, the 0.10mm wall thickness PTFE pipe body.
  • PTFE polytetrafluoroethylene
  • a first sleeve 1113 and a second sleeve 1114 are provided in the radial gap 1110 between the first tube 1111 and the second tube 1112, the diameter of the first sleeve 1113 is smaller than the diameter of the second sleeve 1114, the first The sleeve 1113 passes through the second sleeve 1114 along the axial direction A, so a radial clearance space can also be formed between the first sleeve 1113 and the second sleeve 1114 .
  • the first sleeve 1113 can be threaded coaxially in the second sleeve 1114, or can be slightly staggered and threaded differently, in order to ensure the stability of the overall structure of the sheath and improve the reliability during instrument delivery. In some embodiments, the first sleeve 1113 is coaxially threaded in the second sleeve 1114 along the axis A.
  • the first sleeve 1113 and the second sleeve 1114 can both be mesh structures.
  • Any one of the first casing 1113 and the second casing 1114 can be a network pipe structure formed by pipe cutting, for example, it can be a metal pipe such as a stainless steel pipe; any one of the first casing 1113 and the second casing 1114 can also be It is a network structure formed by weaving braided wires.
  • the braided wires can be metal wires, such as stainless steel wires or tungsten wires, etc.; they can also be non-metallic wires, such as polymer wires and synthetic fiber wires.
  • the first sleeve 1113 is braided from braided wire
  • the second sleeve 1114 is braided from braided wire
  • the diameter of the braided wire of the first sleeve 1113 is larger than that of the braided wire of the second sleeve 1114
  • the braiding pitch of the first sleeve 1113 is smaller than the braiding pitch of the second sleeve 1114 .
  • the first sleeve 1113 can be formed by braiding round or flat metal wires with a diameter of about 0.05 to 0.25 mm, and the braiding pitch is 25 to 50 PPI (PPI: picks per inch, number of intersections per inch) , so that the first sleeve 1113 has a better supporting effect.
  • PPI picks per inch, number of intersections per inch
  • the diameter of the second sleeve tube 1114 needs to be smaller
  • a round stainless steel wire with a diameter of 0.05 to 0.12 mm is selected, and the braiding pitch is 5 to 15 PPI, which is used to better support and protect the sheath.
  • the transition section 113 of the tube body 11 includes a first tube 1131 , a second tube 1132 passing through the first tube 1131 , and a radial tube between the first tube 1131 and the second tube 1132 .
  • the transition sleeve 1135 in the gap, at least part of the traction mechanism 12 passes through the radial gap between the transition sleeve 1135 and the second pipe 1132 .
  • the length of the transition section 113 ranges from about 20 to 30 mm.
  • the first tube 1131 of the transition section 113 and the first tube 1111 of the bending section 111 can be integrally formed, or can be prepared independently and axially connected together to form a coaxial one-piece body.
  • the first pipe 1131 of the transition section 113 can be a pipe body structure made of a polymer elastomer, and the polymer elastomer is a thermoplastic material, usually: PA (nylon), PC (polycarbonate), TPU (thermoplastic polyurethane) Elastomer), PE (polyethylene), PTFE (polytetrafluoroethylene), Pebax (block polyetheramide), etc.
  • PA nylon
  • PC polycarbonate
  • TPU thermoplastic polyurethane
  • PE polyethylene
  • PTFE polytetrafluoroethylene
  • Pebax block polyetheramide
  • the transition section 113 connects the bending section 111 and the main section 112, and its hardness needs to be greater than that of the bending section 111 but less than that of the main section 112, that is, when Pebax is used to prepare the first tube 1131 of the transition section 113, in some implementations
  • the hardness of the Pebax material is 45 to 60D.
  • the second tube 1132 of the transition section 113 and the second tube 1112 of the bending section 111 can be integrally formed, or can be prepared independently and axially connected together by bonding, melting, etc., so as to form a coaxial One body.
  • the second pipe 1132 of the transition section 113 and the second pipe 1112 of the bending section 111 can be two sections of the same pipe body, all of which are pipe structures made of PTFE (polytetrafluoroethylene), such as a wall thickness of The PTFE (polytetrafluoroethylene) tube of 0.05 to 0.30 mm, in a specific embodiment of the embodiment, adopts a PTFE tube body with a wall thickness of 0.10 mm.
  • PTFE polytetrafluoroethylene
  • the transition sleeve 1135 of the transition section 113 is arranged in the radial gap between the first pipe 1131 and the second pipe 1132, and the radial distance of the transition sleeve 1135 relative to the first pipe 1131 is smaller than that of the transition sleeve 1135 relative to the second pipe 1132 At least part of the traction mechanism 12 passes through the radial gap between the transition sleeve 1135 and the second pipe 1132.
  • the specific setting of the transition sleeve 1135 is used to fix and limit the passage through the transition section 113. At least part of the traction mechanism 12 .
  • the transition sleeve 1135 can adopt the same structure as the second sleeve 1114, for example, the second sleeve 1114 extends into the transition section 113 to form the transition sleeve 1135, of course, the transition sleeve 1135 can also be The same structure as the first sleeve 1113 is used, for example, the first sleeve 1113 extends into the transition section 113 to form a transition sleeve 1135 , or other independent structures may also be used, which will not be listed here.
  • the distal end of the main body section 112 is connected with the transition section 113 , and in some embodiments, the proximal end is connected with a handle 13 , and the bending degree of the bending adjustment section 111 is controlled by the handle 13 .
  • the main body section 112 can adopt the same structure as the bending section 111, that is, it includes a first pipe, a second pipe 1112 passing through the first pipe 1111, and a diameter passing between the first pipe 1111 and the second pipe 1112.
  • the structure includes the first tube 1131, the second tube 1132 penetrated in the first tube 1131, and the transition sleeve 1135 penetrated in the radial gap between the first tube 1131 and the second tube 1132, At least part of the traction mechanism 12 passes through the radial gap between the transition sleeve 1135 and the second tube 1132 , and those skilled in the art can select a suitable structure of the main body section 112 based on the guidance of the present disclosure.
  • Pebax can be selected to prepare the first pipe of the main body section 112, and the hardness of the first pipe of the main body section made of Pebax material is: 65 to 80D.
  • the bending section 111, the transition section 113 and the main section 112 are different sections of the same pipe body 11 along the axial direction A, so the bending section 111, the transition section 113 and the main section 112 may all include the first pipe and the second tube, the first tubes in each section can be made of materials with different hardness, and the second tubes in each section can be made of materials with the same hardness, regardless of whether the preparation materials are the same, the structure is Continuous unified tube structure.
  • the traction mechanism 12 includes an anchor ring 121 and a traction wire 122; the anchor ring 121 is fixed at the distal end of the bend adjustment section 111, and the first sleeve 1113 and the second sleeve sleeve of the bend adjustment section 111 In the radial gap of 1114, at least part of the pulling wire 122 is folded in half and passed through the radial gap between the first sleeve 1113 and the second sleeve 1114, and the bending part of the pulling wire 122 is connected with the anchor ring 121 .
  • the anchoring ring 121 is threaded through the distal end of the tubular body 11 and is fused with the second tube 1112 of the bending section 111 , and the pulling wire 122 is anchored A U-shaped bend is formed at the ring 121 to connect with the anchor ring 121.
  • the end of the pulling wire 122 is connected to the bending adjustment mechanism on the handle 13.
  • the pulling wire 122 is pulled by the bending adjustment mechanism, and the anchoring ring 121 is driven to connect with the anchoring ring 121.
  • the fixed ring 121 is connected to the bending section 111, so that the bending section can be bent to a specific angle.
  • the anchor ring 121 can be made of stainless steel, with a wall thickness of 0.1 to 0.5 mm and a length ranging from 3 to 8 mm.
  • the pulling wire 122 passes through the radial gap between the first sleeve 1113 and the second sleeve 1114 of the bending section 111, the transition section 113 and part of the main section 112 in the axial direction A, and passes through the main section 112.
  • the body 11 is free outside the tube body 11.
  • the wire outlet 101 is set at the junction of the transition section 113 and the bending section 111, and through the wire outlet 101 at the junction of the transition section 113 and the bending section 111, the pulling wire 122 is drawn from the first corner of the bending section 111.
  • the sleeve 1113 and the second sleeve 1114 penetrate between the transition sleeve 1135 of the transition section 113 and the second pipe 1132 , continue to extend along the axial direction A in the transition section 113 and enter the main section 112 , where the main section 112 A wire outlet 102 is arranged in the middle, and the pulling wire 122 passes through the wire outlet 102 to pass out of the tube body 11, and freely dissociates outside the tube body 11.
  • the pulling wire 122 can continue to freely move along the axial direction A on the outer wall side of the first tube 1121 of the main body section 112, and the distal end can be connected to the operating handle 13.
  • the pulling wire 122 The free end of the sheath is separated from the main body section 112 of the sheath, which reduces the stress on the inner wall of the sheath, avoids stress concentration, and can better improve the unevenness.
  • the pulling wire 122 when the pulling wire 122 enters the main body section 112 and exits through the wire outlet 102 , it may not pass through the entire tubular body 11 .
  • the pulling wire 122 when the body section 112 is selected to have the same tubular structure as the bending section 111, the pulling wire 122 can be inserted into the radial gap between the first sleeve 1113 and the second sleeve 1114 of the main body 112, or Penetrate between the second sleeve 1114 of the main body section 112 and the second tube 1112; when the main body section 112 adopts the same tube structure as the transition section 113, the pulling wire 122 can pass through the transition sleeve 1135 and the second tube 1132
  • the radial gap between the pull wires 122 depends on the specific structure of the main body section 112 .
  • the traction mechanism 12 also includes a protection tube 123 sheathed outside the traction wire 122.
  • the protection tube 123 is used to accommodate the traction wire 122.
  • the protection tube 123 and the traction wire 122 pass through the first bend-adjusting section 111 sequentially along the axial direction A.
  • the radial gap between the sleeve 1113 and the second sleeve 1114, the radial gap between the transition sleeve 1135 of the transition section 113 and the second tube 1132 and part of the main body section 112, and the wire outlet of the main body section 112 102, the specific form of the protective tube 123 is consistent with that of the traction wire 122 in the main body section 112, and the distal end of the protective tube 123 is connected to the operating handle 13.
  • the pulling wire 122 passes through the protection tube 123 , which not only enhances the strength of the pulling wire 122 , but also prevents the pulling wire 122 folded on the anchoring ring 121 from being cut by the anchoring
  • the protection tube 123 is usually made of PI (polyimide) material, and its inner diameter is about 0.4 to 1.0 mm.
  • the diameter of the pulling wire 122 is slightly smaller than the inner diameter of the protection tube 123 .
  • the outer side of the protective tube 123 can be additionally covered with a reinforcing net to further improve the support of the protective tube 123.
  • the pulling wire 122 is usually made of nickel-titanium or stainless steel, which can be single-strand wire or multi-strand wire. In some embodiments, multi-strand wire braided by stainless steel wire is used, which has good toughness and will not break due to repeated bending , can ensure the stability of the traction mechanism 12.
  • the anchor ring 121 includes an annular body 1211 having a radial protrusion 1212, and the pull wire 122 is connected to the anchor after the radial protrusion 1212 is folded in half. Ring 121.
  • the inner diameter of the protruding space formed by the radial protrusion 1212 is slightly larger than the outer diameter of the protection tube 123, which is conducive to accommodating the protection tube 123, so that the protection tube 123 can extend distally through the radial protrusion 1212 and then turn back in reverse.
  • a U-shape is thereby formed to connect with the anchor ring 121 .
  • the entire PTFE inner membrane is sheathed on the liner rod to form the second tube 1112 of the bending section 111, and the protective tube 123 is fixed in the PTFE with an adhesive film. Then, from the proximal end to the distal end, a layer of braided mesh is placed on the outside of the fixed protective tube 123 to form the first sleeve 1113, and then the anchor ring 121 is cut from the radial protrusion 1212 to the position.
  • the incision 1213 is cut open, the protective tube 123 is put on the anchor ring 121, and finally the anchor ring 121 is embedded in the distal end of the sheath to fix the anchor ring 121.
  • a layer of braided net is put on the outer side of the protective tube 123 to form the second sleeve 1114.
  • This layer of braided net can at least cover the outer side of the bending section 111, and in other examples, it can also be further extended to cover Alternatively, the transition section 113 and the main section 112 may be further sheathed with more layers of braided mesh on the outside of the first sleeve 1113 and the second sleeve 1114 , so as to achieve better support.
  • the protective tube 123 between the tubes 1114 can be fused into a whole with the first tube 1111, the second tube 111, the first sleeve tube 1113 and the second sleeve tube 1114 of the sheath tube after overheating, and the present invention can be obtained.
  • the support of the inner wall of the bending section 111 is greatly improved, and the adjustment is improved.
  • the unevenness of the curved section 111 is likely to cause interference between instruments, thereby greatly improving the smoothness of the instruments, greatly reducing the difficulty of adjustment, reducing the operation time of the operation, and reducing the risk of the operation.
  • the anchor ring 121 includes an annular body 1211 including at least one axial groove 1214 disposed on an outer peripheral surface thereof.
  • the number of grooves 1214 can be set in multiples, and they are evenly spaced along the circumferential direction, and the pulling wire 122 can be passed through one of the axial grooves 1214, so as to achieve traction through the groove 1214.
  • the wire 122 acts as a stable limit to ensure the reliability of pulling and bending; in addition, since multiple grooves 1214 are set at the same time, the groove 1214 that does not accommodate the pulling wire 122 can also increase the anchor ring 121 and the bending section
  • the contact area of the first tube 1111 of 111 makes the anchor ring 121 fully contact with the first tube 1111 of the bending section 111, and improves the overall cooperation between the sheath tube and the traction mechanism 12, thereby improving the stability of the device.
  • the annular body 1211 may also be provided with an axial threading hole 1215, specifically set in one of the grooves 1214, for accommodating the passage of the pulling wire 122, so as to further improve the stability of the pulling wire 122. stability.
  • the anchor ring 121 includes an annular body 1211 and a connecting portion 1216; the connecting portion 1216 stands radially on the outer peripheral surface of the annular body 1211, and the connecting portion 1216 is provided with Two radial through holes 1217a and 1217b, and the connecting portion 1216 includes an arc-shaped groove 1218 arranged between the two radial through holes on its outer peripheral surface; the annular body 1211 is also provided with the radial through holes 1217a and 1217b correspond to two through holes (not shown in the figure).
  • the pulling wire 122 is accommodated in the lumen of the protection tube 123, and the protection tube 123 passes through a perforation of the anchor ring 121, and then passes through two radial through holes 1217a and 1217b of the connecting part 1216 and two The arc-shaped groove 1218 between the through holes passes back to another through hole of the anchoring ring 121 to form a pair of parallel pulling wires 122 .
  • the position where the traction wire 122 turns back and contacts the anchor ring 121 is set as an arc-shaped groove 1218, and the overall arc transition is performed.
  • the arc-shaped groove 1218 can be a 180° semi-circular arc with a radius of 0.6 to 1.0 mm.
  • the protective tube 123 and the pulling wire 122 at the arc-shaped groove 1218 are no longer subject to edge stress or local stress with relatively concentrated stress, thereby preventing the pulling wire 122 from breaking and improving the stability of the device.
  • the inner diameters of the two through holes 1217a and 1217b through which the protective tube 123 passes are slightly larger than the outer diameter of the protective tube 123, and 4 sets of semicircular axial recesses with a radius of 0.3 mm are added outside the anchor ring 121.
  • each set of semicircular axial grooves respectively includes two semicircular axial grooves 1214 that are mirror-symmetrical along the central axis, and four sets of semicircular axial grooves 1214 are evenly distributed along the circumference, thus, when When Pebax is used to make the first pipe 1111 of the bending section 111, the first pipe 1111 of the bending section 111 is melted and formed, and the semicircular groove of the anchor ring 121 is filled with Pebax, which increases the size of the anchor ring 121 and The contact area of the first tube 1111 makes the integrity of the melted sheath tube and the traction mechanism 12 better, and when the sheath tube is bent, it can adapt to a greater traction force of the traction wire 122, thereby improving the stability of the device.
  • the anchor ring 121 includes an annular body 1211, the annular body 1211 is provided with at least one annular groove 1219a coaxial with the annular body 1211, and through the groove 1219b communicates with the two through holes 1219c of the annular groove 1219a respectively.
  • the annular groove 1219a is provided on the outer peripheral surface of the annular body 1211 , and the two through holes 1219c protrude radially, and the width is slightly larger than the outer diameter of the protection tube 123 .
  • the annular groove 1219a is arranged in the axial middle of the anchoring ring 121, and the position where the two sides of the through hole 1219c are in contact with the protection tube 123 is a circular arc transition groove 1219b, and the radius of the circular arc transition groove 1219b is 0.4 With a rounded corner of 1.0mm, the through hole 1219c allows two protective tubes 123 to pass through side by side.
  • the protective tube 123 containing the pulling wire 122 circles around the annular groove 1219a in the middle of the anchor ring 121, passes through the arc transition groove 1219b, and passes through the through hole 1219c to form double pulling wires 122. Due to the limitation of the annular groove 1219a, the protection tube 123 cannot axially slide on the anchor ring 121 . When the sheath is bent, the traction force received by the anchoring ring 121 is evenly distributed on the entire outer circle of the anchoring ring 121, and the protective tube 123 and the traction wire 122 passing through the arc transition groove 1219b are no longer subject to edge stress or stress comparison. Concentrated local stress.
  • each set of semicircular axial grooves 1214 is composed of two semicircular axial grooves mirror-symmetrical along the central axis.
  • Grooves 1214, four sets of semicircular axial grooves 1214 are evenly distributed, and the two semicircular axial grooves 1214 near the through hole are in a semi-penetrating state, and their proximal ends penetrate to the annular groove 1219a.
  • the annular groove 1219a is connected, and the other six semicircular axial grooves 1214 are in a penetrating state.
  • the semicircular axial groove 1214 and the annular groove 1219a of the anchor ring 121 are filled with nylon elastomer, increasing the size of the anchor ring.
  • the contact area between 121 and the first tube 1111 makes the integrity after melting better, thereby improving the stability of the device.
  • an annular groove (not shown) containing the protection tube 123 is provided on the distal end surface 121a of the annular body 1211, and two through holes of the protection tube 123 are accommodated.
  • 121b is arranged along the axial direction A, and its width is slightly larger than the outer diameter of the protection tube 123 .
  • an annular groove is arranged on the distal end surface of the anchoring ring 121 .
  • the pulling wire 122 circles around the upper half of the step of the anchoring ring 121 , passes through the arc transition, and passes through the through hole to form two pulling wires 122 .
  • the traction wire 122 circles around the anchor ring 121, when the sheath tube is bent, the traction force received by the anchor ring 121 is evenly distributed on the entire outer circle of the anchor ring 121, passing through the protective tube 123 and the traction at the arc transition part.
  • the wire 122 is no longer subject to edge stress or local stress with relatively concentrated stress.
  • the adjustable bending sheath 1 also includes one or more developing parts 14 capable of displaying the real-time position of the bending section 111.
  • the developing parts 14 are usually made of materials with good developing effects, such as tantalum, platinum, Iridium or the like, the developing member 14 is a developing ring or a developing point.
  • the number of developing rings can be two, both of which are made of tantalum material.
  • the thickness of the developing rings is 0.05 to 0.20mm.
  • the first developing ring 141 is arranged at the distal end of the adjustable curved sheath tube 1, near The position of the anchor ring 121 , the second developing ring 142 is arranged at the junction of the bending section 111 and the transition section 113 . The purpose of such setting is to make it easier to identify the actual position of the sheath through the relative position between the developing rings to form a reference.
  • the present disclosure also relates to a medical device delivery system, including the adjustable curved sheath 1 of any of the above-mentioned embodiments.
  • the aforementioned medical device delivery system is widely used in the clinical treatment of heart diseases such as mitral regurgitation and tricuspid regurgitation. Reach the diseased part, repair or replace the diseased mitral or tricuspid valve.
  • the medical device delivery system in order to ensure that the drugs or instruments used for treatment can accurately reach the location of the lesion, the medical device delivery system usually also includes a catheter that is used in conjunction with an adjustable curved sheath. The distal angle drives the catheter worn in the adjustable curved sheath to point to the lesion, so that drugs or instruments can be delivered more accurately.
  • the medical devices that can be delivered by the above-mentioned medical device delivery system include, but are not limited to: valve clamping devices, artificial heart valves, annuloplasty rings, artificial chordae, and the like.

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Abstract

可调弯鞘管、包括可调弯鞘管的医疗器械输送系统及制备可调弯鞘管的方法。可调弯鞘管（1）包括管体（11）和牵引机构（12）；管体（11）包括位于远端的调弯段（111）、位于近端的主体段（112）、以及连接调弯段（111）与主体段（112）的过渡段（113），调弯段（111）包括第一管（1111）、穿设于第一管（1111）内的第二管（1112）、以及设于第一管（1111）与第二管（1112）的径向间隙中的第一套管（1113）和第二套管（1114），至少部分牵引机构（12）穿设于第一套管（1113）和第二套管（1114）的径向间隙中。

Description

可调弯鞘管、医疗器械输送系统及制备可调弯鞘管的方法
相关申请的引用
本公开要求于2021年12月31日向中华人民共和国国家知识产权局提交的申请号为202111670815.7、名称为“可调弯鞘管及医疗器械输送系统”的发明专利申请的全部权益，并通过引用的方式将其全部内容并入本文。
领域
本公开涉及医疗器械领域，更具体地涉及可调弯鞘管、包括该可调弯鞘管的医疗器械输送系统以及制备该可调弯鞘管的方法。
背景
二尖瓣是处于心脏左心房与左心室之间的单向阀，正常的二尖瓣可以控制血液从左心房单向流入左心室。而当二尖瓣发生病变，在左心室收缩时无法完全闭合，血液将会从左心室反流回左心房，引起一系列心脏的病理改变和临床症状，严重时甚至会导致心力衰竭，称为“二尖瓣反流”。近年来，介入治疗被广泛用于二尖瓣反流等心脏疾病临床治疗中，具体是指通过特制的导管或鞘管将药物或器械送达病变部位，修复或者替换病变的二尖瓣。
在介入治疗的过程中，为了保证用于治疗的药物或器械能够准确地到达病变的位置，通常会使用配套的导管与可调弯鞘管，通过调节可调弯鞘管的远端角度，带动穿装在可调弯鞘管中的导管指向病变位置，从而顺利地输送药物或者器械。
概述
本公开提供了可调弯鞘管，包括管体和牵引机构；其中，管体包括：位于远端的调弯段、位于近端的主体段、以及连接调弯段与主体段的过渡段，调弯段包括第一管、穿设于第一管内的第二管、以及设于第一管与第二管的径向间隙中的第一套管和第二套管，至少部分牵引机构穿设于第一套管和第二套管的径向间隙中。
在某些实施方案中，所述第一套管和所述第二套管均为网状结构，且所述第一套管穿设于所述第二套管内。
在某些实施方案中，所述第一套管和所述第二套管均由编织丝编织形成；所述第一套管的编织丝的丝径大于所述第二套管的编织丝的丝径，所述第一套管的编织节距小于所述第二套管的编织节距。
在某些实施方案中，所述第一套管的编织丝的丝径为0.05至0.25mm，编织节距为25至50PPI；所述第二套管的编织丝的丝径为0.05至0.12mm，编织节距为5至15PPI。
在某些实施方案中，所述过渡段包括第一管、穿设于所述第一管内的所述第二管、以及设于所述第一管与所述第二管的径向间隙中的过渡套管，至少部分所述牵引机构穿设于所述过渡套管和所述第二管的径向间隙中。
在某些实施方案中，所述牵引机构包括锚定环和牵引丝；所述锚定环固定在所述调弯段的远端处，且位于所述第一套管与所述第二套管的径向间隙中，至少部分所述牵引丝对折后穿设于所述第一套管和所述第二套管的径向间隙中，且所述牵引丝对折的折弯处与所述锚定环连接。
在某些实施方案中，所述牵引丝沿轴向依次穿过所述调弯段的所述第一套管和所述第二套管的径向间隙、所述过渡段以及部分所述主体段，并从所述主体段穿出所述管体，自由游离在所述管体的外部。
在某些实施方案中，所述牵引机构还包括套设在所述牵引丝外的保护管。
在某些实施方案中，所述锚定环包括环状本体，所述环状本体具有径向突出部，所述牵引丝在所述突出部对折后连接至所述锚定环。
在某些实施方案中，所述锚定环包括环状本体，所述环状本体包括设于其外周表面的至少一个轴向凹槽。
在某些实施方案中，所述锚定环包括环状本体和连接部；所述连接部沿径向竖立于所述环状本体的外周表面上，所述连接部设有两个径向通孔，且所述连接部在其外周表面上包括设于所述两个径向通孔之间的弧形凹槽；所述环状本体上还设有与所述径向通孔一一对应贯通的两个穿孔。
在某些实施方案中，所述锚定环包括环状本体，所述环状本体上设有 至少一个与所述环状本体同轴的环形凹槽、以及分别与所述环形凹槽连通的两个通孔。
在某些实施方案中，所述环形凹槽设于所述环状本体的远端面或者外周表面上。
在某些实施方案中，所述可调弯鞘管还包括配置为显示所述调弯段位置的至少一个显影部件。
在某些实施方案中，所述显影部件的数量为两个，其中一个所述显影部件设置在靠近所述锚定环的位置，另一个所述显影部件设置在所述调弯段和所述过渡段的交界处。
本公开还提供了包括上述可调弯鞘管的医疗器械输送系统，还包括活动地穿设于所述可调弯鞘管中的导管。
本公开还提供了制备上述可调弯鞘管的方法，包括：
将整个PTFE内膜套在衬棒上，以形成所述调弯段的所述第二管，并用粘合剂把所述保护管固定在所述PTFE内膜上；
自近端往远端方向，把一层编织网套在已固定好的所述保护管外侧以形成所述第一套管；
把所述锚定环从所述径向突出部正对位置的所述剪切口剪开，把所述保护管套在所述锚定环上；
把所述锚定环嵌在鞘管远端位置，固定所述锚定环；
安装好所述牵引机构后，在所述保护管的外侧套上编织网以形成所述第二套管，所述编织网至少能够覆盖所述调弯段外侧；
使用PET材料等热缩管固定住所述第二套管的两端，并加热所述热缩管使其受热收缩，使得该部位分布在两层所述编织网形成的所述第一套管和所述第二套管之间的所述保护管；以及
经过热熔后，与所述鞘管的所述第一管、所述第二管、所述第一套管和所述第二套管融合成一个整体，得到所述可调弯鞘管。
在某些实施方案中，通过在可调弯鞘管的调弯段中设置两层套管，并设置部分牵引机构在该两层套管之间的径向间隙中穿过，不仅可以大幅提高调弯段的支撑性，还可以改善可调弯鞘管的调弯段内壁容易出现凹凸不平导致器械之间产生干涉的情况，具体通过调整调弯段牵引丝放置于编织 网外侧，调弯时牵引丝的拉力直接作用在编织网上，减小对内膜(即内壁)的影响，从而使得内壁不再容易出现凹凸不平的情况，使得器械的顺畅度大幅提高，调节难度大幅降低，减少了手术的操作时间，降低了手术风险。
附图说明
此处的附图被并入说明书中并构成本说明书的一部分，示出了符合本公开的实施例，并与说明书一起用于解释本公开的原理。
为了更清楚地说明本公开实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，对于本领域普通技术人员而言，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。
图1为依据本公开某些实施例可调弯鞘管的结构示意图；
图2为图1中的调弯段沿垂直于轴向的截面图；
图3为图1中的管体沿轴向的截面图；
图4为图1的可调弯鞘管在调弯段的局部放大图；
图5为图1中的过渡段沿垂直于轴向的截面图；
图6为图1中的牵引机构的结构示意图；
图7为图6中的锚定环的结构示意图；
图8为依据本公开某些实施例可调弯鞘管的锚定环的结构示意图；
图9为依据本公开某些实施例可调弯鞘管的牵引机构的结构示意图；
图10为图9中的锚定环的结构示意图；
图11为依据本公开某些实施例可调弯鞘管的牵引机构的结构示意图；
图12为图11中的锚定环的结构示意图；
图13为依据本公开某些实施例的可调弯鞘管的牵引机构的结构示意图。
详述
为使本公开实施例的目的、技术方案和优点更加清楚，下面将结合本公开实施例中的附图，对本公开实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本公开的一部分实施例，而不是全部的实施例。基于本公开中的实施例，本领域普通技术人员在没有做出创造性劳动 的前提下所获得的所有其他实施例，都属于本公开保护的范围。
在本公开的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便，并不能理解为对本公开的限制。
参见图1至图4，在本公开的某些实施例中，可调弯鞘管1包括管体11和牵引机构12；其中，管体11包括：位于远端的调弯段111、位于近端的主体段112、以及连接调弯段111与主体段112的过渡段113，调弯段111包括第一管1111、同轴穿设于第一管1111内的第二管1112、以及设于第一管1111与第二管1112之间的径向间隙1110中的第一套管1113和第二套管1114，至少部分牵引机构12穿设于第一套管1113和第二套管1114之间的径向间隙1110中。
在某些实施例的可调弯鞘管1(以下可简称为鞘管)中，调弯段111的第一管1111和第二管1112之间的径向间隙1110中设置有双层套管：第一套管1113和第二套管1114，且至少部分牵引机构12在第一套管1113和第二套管1114之间的径向间隙1110中穿过，该结构可以大幅提高调弯段111的支撑性，并改善鞘管的调弯段内壁容易出现凹凸不平导致器械之间产生干涉的情况，因为现有技术鞘管调弯过程中，调弯作用力主要作用在调弯段，如果调弯段牵引丝放置在编织网内侧，牵引丝内侧只有一层比较薄的PTFE内膜(即第二管1112)，通过牵引丝的运动控制调弯段调弯，牵引丝的拉力直接作用在内膜上，内膜容易变形形成凹凸不平的结构。本公开调整调弯段牵引丝放置于编织网外侧，调弯时牵引丝的拉力直接作用在编织网上，对内膜的影响较小，从而使得内膜不再容易出现凹凸不平的情况，从而使得器械的顺畅度大幅提高，调节难度大幅降低，减少了手术的操作时间，降低了手术风险。
在某些实施方案中，管体11沿轴向A从远端到近端依次包括：调弯段111、过渡段113以及主体段112，管体11可以一体成型，也可以分段制作后组合并连接。
调弯段111设于可调弯鞘管1的管体11靠近远端的部分，用于实现鞘管的弯曲，如图1中显示的已调弯的调弯段111’。调弯段111的长度约为40至60mm，且弯曲角度可调，使得可调弯鞘管1能够适应人体复杂的血管路 径。如图2所示，调弯段111包括均沿轴向A设置的第一管1111和第二管1112，第一管1111的管径大于第二管1112的管径，第二管1112同轴设于第一管1111内，因此在第一管1111的内壁与第二管1112的外壁之间形成径向间隙1110。
第一管1111可以为高分子弹性体制成的管体结构，该高分子弹性体为热塑性材料，通常为：PA(尼龙)、PC(聚碳酸酯)、TPU(热塑性聚氨酯弹性体)、PE(聚乙烯)、PTFE(聚四氟乙烯)、Pebax(嵌段聚醚酰胺)等。为确保操作中可顺利对调弯段111进行调弯操作，需要合理设置调弯段111的硬度，即当采用Pebax制备调弯段111的第一管1111时，在某些实施方案中，该Pebax材料的硬度为20至40D。
第二管1112可以为PTFE(聚四氟乙烯)材料制成的管体结构，例如壁厚为0.05至0.30mm的PTFE(聚四氟乙烯)管，在实施例的一具体实施方式中，采用0.10mm壁厚的PTFE管体。
在第一管1111与第二管1112的径向间隙1110中设有第一套管1113和第二套管1114，第一套管1113的管径小于第二套管1114的管径，第一套管1113沿轴向A穿设于第二套管1114内，因此在第一套管1113与第二套管1114之间也可以形成径向的间隙空间。在某些实施方案中，第一套管1113可以同轴穿设于第二套管1114内，也可以稍微错开不同轴穿设，为了确保鞘管整体结构稳定，提高器械输送过程中的可靠性，在某些实施方案中，第一套管1113沿轴向A同轴穿设于第二套管1114内。
在某些实施方案中，第一套管1113和第二套管1114可以均为网状结构。第一套管1113和第二套管1114中的任一个可以是管材切割形成的网管结构，例如可以是不锈钢管等金属管；第一套管1113和第二套管1114中的任一个也可以是编织丝编织形成的网管结构，该编织丝可以是金属丝，例如不锈钢丝或钨丝等；也可以是非金属丝，例如高分子聚合物丝和合成纤维丝等。
在某些实施方案中，第一套管1113由编织丝编织形成，第二套管1114由编织丝编织形成，且第一套管1113的编织丝的丝径大于第二套管1114的编织丝的丝径，第一套管1113的编织节距小于第二套管1114的编织节距。在某些实施方案中，可采用直径约为0.05至0.25mm的圆形或者扁形金属丝 编织形成第一套管1113，编织节距为25至50PPI(PPI：picks per inch，每英寸交叉数)，使第一套管1113具有较佳的支撑作用。考虑鞘管的整体尺寸，为了防止鞘管的调弯段111的外径尺寸偏大，兼顾调弯段的第一管1111不易被牵引机构撑破，第二套管1114的需选用直径较小的金属丝，在某些实施方案中，选用直径为0.05至0.12mm的圆形不锈钢丝，编织节距为5至15PPI，用于更好地支撑和保护鞘管。
结合图5所示，管体11的过渡段113包括第一管1131、穿设于第一管1131内的第二管1132、以及设于第一管1131与第二管1132之间的径向间隙中的过渡套管1135，至少部分牵引机构12在过渡套管1135和第二管1132之间的径向间隙中穿过。过渡段113的长度范围约为20至30mm，过渡段113的第一管1131与调弯段111的第一管1111可以一体成型制成，也可以独立制备后通过粘接、熔融等方式轴向连接在一起，从而形成同轴的一体管体。其中，过渡段113的第一管1131可以为高分子弹性体制成的管体结构，该高分子弹性体为热塑性材料，通常为：PA(尼龙)、PC(聚碳酸酯)、TPU(热塑性聚氨酯弹性体)、PE(聚乙烯)、PTFE(聚四氟乙烯)、Pebax(嵌段聚醚酰胺)等。过渡段113连接调弯段111与主体段112，其硬度需大于调弯段111的硬度但小于主体段112的硬度，即当采用Pebax制备过渡段113的第一管1131时，在某些实施方案中，该Pebax材料的硬度为45至60D。
同样地，过渡段113的第二管1132与调弯段111的第二管1112可以一体成型制成，也可以独立制备后通过粘接、熔融等方式轴向连接在一起，从而形成同轴的一体管体。例如，过渡段113的第二管1132和调弯段111的第二管1112可以为同一管体的两段，均为PTFE(聚四氟乙烯)材料制成的管体结构，如壁厚为0.05至0.30mm的PTFE(聚四氟乙烯)管，在实施例的一具体实施方式中，采用0.10mm壁厚的PTFE管体。
过渡段113的过渡套管1135设于第一管1131与第二管1132之间的径向间隙中，过渡套管1135相对第一管1131的径向距离小于过渡套管1135相对第二管1132的径向距离，至少部分牵引机构12在过渡套管1135和第二管1132之间的径向间隙中穿过，过渡套管1135的具体设置，用于固定并限位穿过过渡段113的至少部分牵引机构12。在某些实施方案中，过渡套管1135可以采用与第二套管1114相同的结构，例如，第二套管1114延伸到过 渡段113中形成过渡套管1135，当然，过渡套管1135也可以采用第一套管1113相同的结构，例如，第一套管1113延伸到过渡段113中形成过渡套管1135，或者也可以是其他独立结构，此处不再一一列举。
主体段112的远端与过渡段113连接，在某些实施方案中，近端连接有手柄13，通过手柄13操作控制调弯段111的弯曲程度。主体段112可以采用调弯段111一样的结构，即包括第一管、穿设于第一管1111内的第二管1112、以及穿设于第一管1111与第二管1112之间的径向间隙中的第一套管1113和第二套管1114，至少部分牵引机构12在第一套管1113和第二套管1114之间的径向间隙中穿过；也可以采用过渡段113一样的结构，即包括第一管1131、穿设于第一管1131内的第二管1132、以及穿设于第一管1131与第二管1132之间的径向间隙中的过渡套管1135，至少部分牵引机构12在过渡套管1135和第二管1132之间的径向间隙中穿过，本领域的普通技术人员可以基于本公开的指导选择适合的主体段112结构。在某些实施方案中由于主体段112的一端与操作手柄13连接，为确保操作可控，可以选用Pebax制备主体段112的第一管，Pebax材料制成的主体段的第一管的硬度为65至80D。
需要说明的是，调弯段111、过渡段113和主体段112为同一管体11沿轴向A的不同分段，因此调弯段111、过渡段113和主体段112可以均包括第一管和第二管，各段中的第一管可以分别采用硬度不相同的材料制成，各段中的第二管可以分别采用硬度相同的材料制成，无论制备材料是否相同，结构上均为连续的统一管体结构。
结合图6所示，牵引机构12包括锚定环121和牵引丝122；锚定环121固定在调弯段111的远端处，位于调弯段111的第一套管1113与第二套管1114的径向间隙中，至少部分牵引丝122对折后穿设于第一套管1113和第二套管1114的径向间隙中，且牵引丝122对折后的折弯处与锚定环121连接。
在某些实施方案中，结合图3至图4所示，锚定环121穿设在管体11的远端，与调弯段111的第二管1112熔为一体，牵引丝122在锚定环121处形成U形弯折以与锚定环121连接，牵引丝122的端部与手柄13上的调弯机构连接，通过调弯机构牵拉牵引丝122，经锚定环121带动与锚定环121连接的调弯段111，从而实现调弯段弯曲到特定角度。锚定环121可以由不锈钢 材质制成，壁厚为0.1至0.5mm，长度范围为3至8mm。
牵引丝122沿轴向A依次穿过调弯段111的第一套管1113和第二套管1114之间的径向间隙、过渡段113以及部分主体段112，并在主体段112穿出管体11，自由游离在管体11外。其中，在过渡段113与调弯段111的交界处设置出丝口101，通过在过渡段113与调弯段111的交界处的出丝口101，牵引丝122从调弯段111的第一套管1113和第二套管1114之间穿入过渡段113的过渡套管1135与第二管1132之间，在过渡段113中沿轴向A继续延伸并进入主体段112，在主体段112中设置出丝口102，牵引丝122通过出丝口102穿出管体11，自由游离在管体11外。牵引丝122在主体段112穿出管体11后，可继续沿着轴向A在主体段112的第一管1121的外壁侧自由游离，远端可与操作手柄13连接，此时牵引丝122的自由端与鞘管的主体段112相互分离，减少了鞘管内壁受到的应力，避免了应力集中，也可以更好地改善凹凸不平的情况。
在某些实施方案中，牵引丝122在进入主体段112后，通过出丝口102穿出时，可以不穿出整个管体11。例如，当主体段112选用与调弯段111相同的管体结构时，牵引丝122可以选择穿入主体段112的第一套管1113和第二套管1114之间的径向间隙中，或者穿入主体段112的第二套管1114和第二管1112之间；当主体段112选用与过渡段113相同的管体结构时，牵引丝122可以穿过过渡套管1135和第二管1132之间的径向间隙，牵引丝122具体的穿出形式取决于主体段112具体的结构设置。
牵引机构12还包括套设在牵引丝122外的保护管123，保护管123用于容纳牵引丝122，保护管123与牵引丝122一并沿轴向A依次穿过调弯段111的第一套管1113和第二套管1114之间的径向间隙、过渡段113的过渡套管1135与第二管1132之间的径向间隙以及部分主体段112，并从主体段112的出丝口102穿出，保护管123具体的穿出形式与主体段112中牵引丝122的穿出形式保持一致，保护管123的远端与操作手柄13连接。牵引丝122穿设于保护管123内，不仅可以增强牵引丝122的强度，还可避免在锚定环121上翻折的牵引丝122受到锚定环121的切割而断裂。
在某些实施方案中，保护管123通常选用PI(聚酰亚胺)材料制成，内径约为0.4至1.0mm。牵引丝122直径略小于保护管123道的内径。在某些实施 方案中，保护管123道外侧可以另外覆盖加强网，进一步提高保护管123的支撑性。牵引丝122通常采用镍钛或者不锈钢材质，可以是单股丝或多股丝，在某些实施方案中，采用由不锈钢丝编织而成的多股丝，韧性好，不会因为反复弯曲而折断，可确保牵引机构12的稳定性。
参见图6和图7，在某些实施例中，锚定环121包括环状本体1211，环状本体1211具有径向突出部1212，牵引丝122在径向突出部1212对折后连接至锚定环121。该径向突出部1212形成的外突空间的内径略大于保护管123的外径，有利于容纳保护管123，使得保护管123能够向远端延伸穿过径向突出部1212再反向折回，从而形成U型以与锚定环121连接。
在可调弯鞘管1的一示例制备过程中，首先将整个PTFE内膜套在衬棒上，以形成调弯段111的第二管1112，并用粘合剂把保护管123固定在PTFE内膜上。然后，自近端往远端方向，把一层编织网套在已固定好的保护管123外侧以形成第一套管1113，随后把锚定环121从径向突出部1212正对位置的剪切口1213剪开，把保护管123套在锚定环121上，最后把锚定环121嵌在鞘管远端位置，固定锚定环121。安装好牵引机构12后，在保护管123的外侧套上一层编织网以形成第二套管1114，这层编织网至少能够覆盖调弯段111外侧，在其他示例中，也可以进一步延伸覆盖过渡段113和主体段112，或者可以在第一套管1113和第二套管1114的外部继续套设更多层的编织网，从而达到更好的支撑性。之后，使用PET材料等热缩管固定住第二套管1114的两端，并加热热缩管使其受热收缩，使得该部位分布在两层编织网形成的第一套管1113和第二套管1114之间的保护管123，经过过热熔后，与鞘管的第一管1111、第二管111、第一套管1113和第二套管1114能够融合成一个整体，即可得到本发明的可调弯鞘管1。
本实施例中，通过设置调弯段111的中间的双层套管结构，且牵引机构12部分穿装于两层套管之间，大幅提高了调弯段111内壁的支撑性，改善了调弯段111容易出现的凹凸不平、导致器械之间产生干涉的情况，从而使得器械的顺畅度大幅提高，调节难度大幅降低，减少了手术的操作时间，降低了手术风险。
参见图8，在某些实施例中，锚定环121包括环状本体1211，环状本体1211包括设于其外周表面的至少一个轴向凹槽1214。在某些实施方案中， 凹槽1214的数量可以设置多个，且沿周向均匀间隔分布，牵引丝122可穿设于其中一个轴向凹槽1214中，从而通过该凹槽1214实现对牵引丝122起到稳定限位作用，确保牵拉调弯的可靠性；此外，由于同时设置多个凹槽1214，未容纳牵引丝122的凹槽1214还可以增大锚定环121和调弯段111的第一管1111的接触面积，使锚定环121和调弯段111的第一管1111充分接触，提高鞘管和牵引机构12的整体配合，从而提高器械的稳定性。
在另一变形实施方式中，环状本体1211上还可以开设有轴向穿线孔1215，具体是设置在其中一个凹槽1214中，用于容纳牵引丝122穿过，从而进一步提高牵引丝122的稳定性。
参见图9和图10，在某些实施例中，锚定环121包括环状本体1211和连接部1216；连接部1216沿径向竖立于环状本体1211的外周表面上，连接部1216设有两个径向通孔1217a和1217b，且连接部1216在其外周表面上包括设于两个径向通孔之间的弧形凹槽1218；环状本体1211上还设有与径向通孔1217a和1217b一一对应贯通的两个穿孔(图中未示出)。
在某些实施方案中，牵引丝122容纳在保护管123内腔中，保护管123穿过锚定环121的一个穿孔，然后经过连接部1216的两个径向通孔1217a和1217b和两个通孔之间的弧形凹槽1218，再穿回锚定环121的另一个穿孔，形成并列的双根牵引丝122。
牵引丝122折返回来与锚定环121接触的位置设置为弧形凹槽1218，整体以进行圆弧过渡，该弧形凹槽1218可以为半径为0.6至1.0mm的180°半圆弧。当鞘管调弯时，弧形凹槽1218处的保护管123及牵引丝122不再受到棱角边应力或者应力比较集中的局部应力，从而避免牵引丝122断裂，提高器械稳定性。此外，容纳保护管123穿过的两个通孔1217a和1217b的内径比保护管123的外径略大，并在锚定环121外侧增加了4组半径为0.3mm的半圆形轴向凹槽，每组半圆形轴向凹槽分别包括沿中轴线镜像对称的两个半圆形轴向凹槽1214，四组半圆形轴向凹槽1214沿圆周呈均匀分布，由此，当采用Pebax制作调弯段111的第一管1111时，先将调弯段111的第一管1111熔融成型，此时锚定环121的半圆槽内充满了Pebax，增大了锚定环121和第一管1111的接触面积，使得熔融后的鞘管和牵引机构12的整体性更好，在鞘管调弯时，能适应更大牵引丝122牵引力，从而提高器械的稳定性。
参见图11和图12，在某些实施例中，锚定环121包括环状本体1211，环状本体1211上设有至少一个与环状本体1211同轴的环形凹槽1219a、以及通过凹槽1219b分别与环形凹槽1219a连通的两个通孔1219c。在本实施例的一具体实施方式中，环形凹槽1219a设于环状本体1211的外周表面上，两个通孔1219c沿径向伸出设置，宽度略比保护管123外径大。在某些实施方案中，环形凹槽1219a设置在锚定环121的轴向中部，通孔1219c两侧与保护管123接触位置为圆弧过渡凹槽1219b，圆弧过渡凹槽1219b为半径0.4至1.0mm的圆角，通孔1219c允许双根保护管123并列通过。
本实施例中，容纳牵引丝122的保护管123绕锚定环121中部的环形凹槽1219a一圈、经过圆弧过渡凹槽1219b、穿过通孔1219c后形成双根牵引丝122。由于环形凹槽1219a的限位，保护管123在锚定环121上不会发生轴向滑动。当鞘管调弯时，锚定环121受到的牵引力均匀分布在锚定环121整个外圆部分，经过圆弧过渡凹槽1219b的保护管123及牵引丝122不再受到棱角边应力或者应力比较集中的局部应力。另外锚定环121外侧增加了4组半径为0.3mm的半圆形轴向凹槽1214，每组半圆形轴向凹槽1214分别由沿中轴线镜像对称的两个半圆形轴向凹槽1214组成，四组半圆形轴向凹槽1214呈均匀分布状态，其中靠近通孔的两个半圆形轴向凹槽1214为半贯穿状态，其近端贯穿至环形凹槽1219a，与环形凹槽1219a连通，其余6个半圆形轴向凹槽1214为贯穿状态。当制备第一管1111的外层尼龙弹性体完成熔融成型后，锚定环121的半圆形轴向凹槽1214内及环形凹槽1219a内均充满了尼龙弹性体，增大了锚定环121和第一管1111的接触面积，使得熔融后的整体性更好，从而提高了器械的稳定性。
参见图13，在某些实施例中，容纳有保护管123的环形凹槽(图中未示出)设于环状本体1211的远端端面121a上，容纳有保护管123的两个通孔121b沿轴向A设置，宽度略比保护管123外径大，在某些实施方案中，环形凹槽设置在锚定环121的远端端面上。本实施方式中，牵引丝122绕锚定环121的台阶上半部分一圈，经过圆弧过渡处，穿过通孔形成双根牵引丝122。由于牵引丝122绕锚定环121一圈，当鞘管调弯时，锚定环121受到的牵引力均匀分布在锚定环121整个外圆部分，经过圆弧过渡部位的保护管123道及牵引丝122不再受到棱角边应力或者应力比较集中的局部应力。
在某些实施方案中，可调弯鞘管1还包括能够显示调弯段111实时位置的一个或多个显影部件14，显影部件14通常由显影效果良好的材料制成，如钽、铂、铱等，显影部件14为显影环或者显影点。在某些实施方案中，显影环的数量可以为两个，均为钽材料制成，显影环厚度为0.05至0.20mm，第一个显影环141设置在可调弯鞘管1远端，靠近锚定环121的位置，第二个显影环142设置在调弯段111和过渡段113的交界处。这样设置的目的是通过显影环之间的相对位置形成参照，更容易识别鞘管的实际位置。
本公开还涉及医疗器械输送系统，包括上述任一实施例的可调弯鞘管1。前述的医疗器械输送系统被广泛用于二尖瓣反流、三尖瓣反流等心脏疾病临床治疗中，具体指通过特制的可调弯鞘管构建体外-体内的通路，将药物或器械送达病变部位，修复或者替换病变的二尖瓣或者三尖瓣。在某些实施方案中，为了保证用于治疗的药物或器械能够准确地到达病变的位置，医疗器械输送系统通常还包括与可调弯鞘管配套使用的导管，通过调节可调弯鞘管的远端角度，带动穿装在可调弯鞘管中的导管指向病变位置，从而更精确地输送药物或者器械。上述医疗器械输送系统可输送的医疗器械包括但不限于：瓣膜夹持装置、人工心脏瓣膜、瓣膜成形环、人工腱索等。
需要说明的是，在本文中，诸如“第一”和“第二”等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
以上所述仅是本公开的详述，使本领域技术人员能够理解或实现本公开。对这些实施例的多种修改对本领域的技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本公开的精神或范围的情况下，在 其它实施例中实现。因此，本公开将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (17)

  1. 可调弯鞘管，包括管体和牵引机构；其中，所述管体包括：位于远端的调弯段、位于近端的主体段、以及连接所述调弯段与所述主体段的过渡段，所述调弯段包括第一管、穿设于所述第一管内的第二管、以及设于所述第一管与所述第二管的径向间隙中的第一套管和第二套管，至少部分所述牵引机构穿设于所述第一套管和所述第二套管的径向间隙中。
  2. 如权利要求1所述的可调弯鞘管，其中，所述第一套管和所述第二套管均为网状结构，且所述第一套管穿设于所述第二套管内。
  3. 如权利要求2所述的可调弯鞘管，其中，所述第一套管和所述第二套管均由编织丝编织形成；所述第一套管的编织丝的丝径大于所述第二套管的编织丝的丝径，所述第一套管的编织节距小于所述第二套管的编织节距。
  4. 如权利要求3所述的可调弯鞘管，其中，所述第一套管的编织丝的丝径为0.05至0.25mm，编织节距为25至50PPI；所述第二套管的编织丝的丝径为0.05至0.12mm，编织节距为5至15PPI。
  5. 如权利要求1至4中任一权利要求所述的可调弯鞘管，其中，所述过渡段包括第一管、穿设于所述第一管内的所述第二管、以及设于所述第一管与所述第二管的径向间隙中的过渡套管，至少部分所述牵引机构穿设于所述过渡套管和所述第二管的径向间隙中。
  6. 如权利要求1至5中任一权利要求所述的可调弯鞘管，其中，所述牵引机构包括锚定环和牵引丝；所述锚定环固定在所述调弯段的远端处，且位于所述第一套管与所述第二套管的径向间隙中，至少部分所述牵引丝对折后穿设于所述第一套管和所述第二套管的径向间隙中，且所述牵引丝对折的折弯处与所述锚定环连接。
  7. 如权利要求6所述的可调弯鞘管，其中，所述牵引丝沿轴向依次穿过所述调弯段的所述第一套管和所述第二套管的径向间隙、所述过渡段以及部分所述主体段，并从所述主体段穿出所述管体，自由游离在所述管体的外部。
  8. 如权利要求6或7所述的可调弯鞘管，其中，所述牵引机构还包括套设在所述牵引丝外的保护管。
  9. 如权利要求6至8中任一权利要求所述的可调弯鞘管，其中，所述锚定环包括环状本体，所述环状本体具有径向突出部，所述牵引丝在所述突出部对折后连接至所述锚定环。
  10. 如权利要求6至8中任一权利要求所述的可调弯鞘管，其中，所述锚定环包括环状本体，所述环状本体包括设于其外周表面的至少一个轴向凹槽。
  11. 如权利要求6至8中任一权利要求所述的可调弯鞘管，其中，所述锚定环包括环状本体和连接部；所述连接部沿径向竖立于所述环状本体的外周表面上，所述连接部设有两个径向通孔，且所述连接部在其外周表面上包括设于所述两个径向通孔之间的弧形凹槽；所述环状本体上还设有与所述径向通孔一一对应贯通的两个穿孔。
  12. 如权利要求6至8中任一权利要求所述的可调弯鞘管，其中，所述锚定环包括环状本体，所述环状本体上设有至少一个与所述环状本体同轴的环形凹槽、以及分别与所述环形凹槽连通的两个通孔。
  13. 如权利要求12所述的可调弯鞘管，其中，所述环形凹槽设于所述环状本体的远端面或者外周表面上。
  14. 如权利要求1至13中任一权利要求所述的可调弯鞘管，其中，所述 可调弯鞘管还包括配置为显示所述调弯段位置的至少一个显影部件。
  15. 如权利要求14所述的可调弯鞘管，其中，所述显影部件的数量为两个，其中一个所述显影部件设置在靠近所述锚定环的位置，另一个所述显影部件设置在所述调弯段和所述过渡段的交界处。
  16. 医疗器械输送系统，包括权利要求1至15任一权利要求所述的可调弯鞘管以及活动地穿设于所述可调弯鞘管中的导管。
  17. 制备权利要求1至15中任一权利要求所述的可调弯鞘管的方法，包括：
    将整个PTFE内膜套在衬棒上，以形成所述调弯段的所述第二管，并用粘合剂把所述保护管固定在所述PTFE内膜上；
    自近端往远端方向，把一层编织网套在已固定好的所述保护管外侧以形成所述第一套管；
    把所述锚定环从所述径向突出部正对位置的所述剪切口剪开，把所述保护管套在所述锚定环上；
    把所述锚定环嵌在鞘管远端位置，固定所述锚定环；
    安装好所述牵引机构后，在所述保护管的外侧套上编织网以形成所述第二套管，所述编织网至少能够覆盖所述调弯段外侧；
    使用PET材料等热缩管固定住所述第二套管的两端，并加热所述热缩管使其受热收缩，使得该部位分布在两层所述编织网形成的所述第一套管和所述第二套管之间的所述保护管；以及
    经过热熔后，与所述鞘管的所述第一管、所述第二管、所述第一套管和所述第二套管融合成一个整体，得到所述可调弯鞘管。
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