WO2015032291A1 - 可调弯鞘管及具有该可调弯鞘管的输送系统 - Google Patents

可调弯鞘管及具有该可调弯鞘管的输送系统 Download PDF

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Publication number
WO2015032291A1
WO2015032291A1 PCT/CN2014/085428 CN2014085428W WO2015032291A1 WO 2015032291 A1 WO2015032291 A1 WO 2015032291A1 CN 2014085428 W CN2014085428 W CN 2014085428W WO 2015032291 A1 WO2015032291 A1 WO 2015032291A1
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WO
WIPO (PCT)
Prior art keywords
sheath tube
tubular body
sheath
distal end
section
Prior art date
Application number
PCT/CN2014/085428
Other languages
English (en)
French (fr)
Inventor
曾敏
张志飞
Original Assignee
杭州启明医疗器械有限公司
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Filing date
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Publication of WO2015032291A1 publication Critical patent/WO2015032291A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0062—Catheters; Hollow probes characterised by structural features having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

Definitions

  • the invention belongs to the technical field of medical instruments, and in particular relates to an adjustable curved sheath tube and a conveying system having the adjustable curved sheath tube.
  • Interventional surgery has less trauma to the human body and less invasiveness. It is a medical technology that has been rapidly developed and promoted in recent years. It usually requires interventional treatment of sheaths (such as delivery sheaths, guiding sheaths, etc.) in patients. A path is established between the lesion location and the external operating end to introduce a medical device, a drug, an implanted device, etc. to the lesion.
  • the interventional treatment sheath has a distal end and a proximal end, the distal end can enter the vasculature of the human body, and the proximal end is connected with the operating handle.
  • the guide wire track is usually established in advance, and the distal end of the sheath tube or the communication is connected. Other auxiliary instruments are punctured into the blood vessel, and the physician controls the distal end of the sheath tube to travel along the previously established guide wire track to the lesion site to release drugs, instruments, and the like by operating the handle.
  • the sheath should generally have sufficient axial and radial support and good compliance. Before reaching the lesion, the sheath itself is pushed by the physician. Compliance is provided to allow the distal end of the sheath to adaptively adjust the direction of curvature to conform to the body's veins as it travels along the guidewire track. Due to the influence of intravascular blood flow, the sheath usually advances along the vessel wall. In the early stage, this does not have much influence on the path of the sheath. However, when the drug or device is released, the distal end of the sheath is required. In the quasi-lesion site, it is obvious that the direction of the distal end of the sheath must be adjusted and controlled to move to the target position.
  • the heart valve of the human body is located at the center of the blood vessel.
  • the distal end of the sheath needs to reach the center of the valve, and then the heart valve replacement device is released to make the heart valve.
  • the replacement device replaces its own valve travel function. Since the sheath is advanced along the vessel wall, it is necessary to adjust the direction of the distal end of the sheath toward the center of the valve, such as the aortic valve, near the lesion site.
  • the diameter of the blood vessel is about 26 mm, and the diameter of the blood vessel is obviously larger than the diameter of the aortic valve.
  • the diameter of the distal end of the sheath is about 7 mm, so that the distal end of the sheath should be moved at least about 9 mm in the diameter direction of the blood vessel.
  • a distally adjustable sheath usually with one or more traction wires (also called pull wires), the distal end of which is fixed at the distal end of the sheath and extends all the way to the sheath
  • the proximal end is coupled to an adjustment mechanism on the proximal handle of the sheath that is slidable within the catheter to allow the physician to actively change the curvature of the catheter, bend the distal end of the sheath, and direct its turn to the target site.
  • Chinese Patent Publication No. CN102921089A discloses a controllable curved catheter for interventional treatment of a head.
  • the multi-lumen catheter is connected with a main catheter soft head, and the tail of the multi-lumen catheter is connected to the extension tube through a connecting piece to extend
  • a handle is arranged outside the tube, and a handle sliding device is movably connected in the handle, and the sliding device is press-fitted with the extension tube.
  • the upper and lower ends of the sliding device extend outside the housing of the handle, and a pulling wire is respectively connected to the upper and lower sides of the sliding device.
  • the other end of the traction wire is fixedly connected to the head of the main catheter soft head through the multi-lumen catheter and the auxiliary cavity on the same side of the main catheter soft head, and the other end of the extension tube extends outside the handle, and the joint is connected.
  • the traction wire is controlled by the handle, and the traction wire pulls the main catheter soft head at the distal end of the catheter by the traction force of the handle sliding device, and the main catheter soft head is pulled back by the pulling wire. Bend to achieve direction adjustment.
  • the catheter of the above structure allows the doctor to actively change the curvature of the catheter to achieve any angular bending of the distal end of the catheter 360°, but in actual surgical operation, the distal end can be bent due to the deflection of the distal end angle of the sheath.
  • the alignment between the direction and the target position needs to be confirmed again, and the image of the interventional treatment is often a planar projection image, which greatly increases the dependence on the doctor's experience in the actual operation.
  • the invention provides an adjustable curved sheath tube, which is beneficial to the adjustment of the distal direction of the sheath tube, improves the controllability of the bending direction of the distal end of the sheath tube, and can easily control the distal end of the sheath tube to move to the lesion portion.
  • An adjustable curved sheath tube comprising a tubular body, the tubular body having a distal end and a proximal end, wherein the tubular body of the tubular body is provided with a reinforcing rib and a pulling wire in the axial direction, and the distal end of the pulling wire Fixed to the distal end of the tubular body, the proximal end of the traction wire extends out of the tubular body for connection with the operating handle.
  • the arrangement of the ribs positions the bending direction of the pipe body, and the sheath pipe is not easily bent in the radial direction of the rib and the pipe body axis, and the sheath is bent when the sheath wire is bent along the guide wire in the blood vessel.
  • the tube will be adaptive to the bending process with the most easily bendable side, that is, the vertical direction of the line connecting the rib to the axis of the tube, in order to conform to the vascular system of the human body, when the sheath tracks through the blood vessel After the bending part, the sheath will adaptively bend the flexible direction toward the center of the blood vessel. At this time, pulling the pulling wire can bend and move the distal end of the sheath toward the center of the blood vessel.
  • the number of ribs should not be too much, and one or two can be set.
  • the pulling wire is one piece, and the reinforcing rib is one piece.
  • a traction wire can only achieve one-way adjustment.
  • the sheath tube needs to be turned in the direction opposite to the traction wire, the sheath can be rotated by about 180°, and then the traction wire is pulled.
  • the traction wire should avoid excessively close to the reinforcing rib, otherwise it is necessary to apply a large pulling force to the traction wire to be able to pull the distal end of the sheath to bend, which is difficult to operate.
  • the angle between the reinforcing rib and the center of the pulling wire is 30 to 150° on any section of the pipe body.
  • the angle between the reinforcing rib and the center of the pulling wire is 80 to 100°.
  • cross section of the pipe body refers to the radial section of the pipe body, and the angle between the reinforcing rib and the center of the traction wire is the angle between the reinforcing rib, the pulling wire and the center of the section.
  • the reinforcing ribs are one piece, and the pulling wires are two, and the two pulling wires are distributed on both sides of the connecting line of the reinforcing ribs and the pipe body axis in the radial direction.
  • Two traction wires can be set to achieve two-way adjustment.
  • the angle between the reinforcing rib and the center of any one of the pulling wires is 30 ⁇ 150° on any section of the pipe body.
  • the angle between the reinforcing rib and the center of any one of the pulling wires is 80 to 100°.
  • a rib may cause the sheath to be twisted during the process of travel.
  • the rib can be set to two.
  • the two ribs can also define the bending direction of the sheath more strictly.
  • the pulling wire is one, and the reinforcing ribs are two.
  • the two reinforcing ribs are on the opposite side of the axial center of the pipe body.
  • the angle between the center of any one of the reinforcing ribs and the pulling wire is 30 ⁇ 150°.
  • the angle between any one of the reinforcing ribs and the center of the pulling wire is 80 to 100 degrees.
  • the traction wires are two, and the reinforcing ribs are two, and the traction wires are spaced apart from the reinforcing ribs in the circumferential direction of the tubular body.
  • the two reinforcing ribs are on the opposite side of the axial center of the pipe body, and any one of the reinforcing ribs and one of the pulling wires is on any section of the pipe body.
  • the center angle is 30 ⁇ 150°.
  • any one of the reinforcing ribs has an angle of 80 to 100° with the center of one of the pulling wires.
  • the two reinforcing ribs are located on opposite sides of the axial center of the tubular body, that is, two reinforcing ribs on opposite sides of the tubular body, so that the sheath is not easily folded in the radial direction of the two reinforcing ribs.
  • the bend can only be bent in the direction of the vertical line of the two reinforcing ribs. When pulling the pulling wire, the distal end of the sheath is inevitably and more easily bent in the most flexible direction (direction of the pulling wire).
  • the two reinforcing ribs may not be arranged opposite each other.
  • the center angle of the two reinforcing ribs is less than 180°, and the pulling wire is on the side of the line connecting any of the reinforcing ribs and the axis of the pipe body in the radial direction.
  • the sheath tube is not bent in the radial direction of each of the reinforcing ribs and the axis of the tube body. Therefore, when the traction wire is disposed, the traction wire should be prevented from being distributed in the radial direction of any one of the reinforcing ribs and the axis of the tube body. Connection direction.
  • the adjustable curved sheath tube further includes an expansion section in communication with the tubular body, the expansion section being coupled to the distal end side of the tubular body and for receiving an implant device.
  • the expansion section and the pipe body are connected by a thickened transition section, and the outer wall of the transition section and the expansion section and the pipe body are smoothly transitioned, and the distal end of the reinforcing rib extends and is fixed in the transition section Inside.
  • the part connecting the tube body and the expansion section is a weak link, and the transition section can avoid the fate and fold at the time of turning, affecting the release of the implanted device, and in addition, during the running, the expansion section contains the implanted device, and
  • the implanted instrument is in a compressed state, so the expansion section has a strong radial support force, and the implanted instrument affects the flexibility of the expansion section to a certain extent, and the distal end of the rib is fixed in the transition section to avoid reinforcement
  • the ribs have an effect on their compliance.
  • the present invention also provides a delivery system comprising the adjustable curved sheath tube, a sheath core disposed within the adjustable curved sheath tube, and an operating handle fixed to the proximal end of the adjustable curved sheath tube and sheath core The proximal end of the traction wire is fixed to the operating handle.
  • the sheath core comprises a core tube, the distal end of the core tube is fixed with a guiding head and an interventional instrument fixing head, and the core tube is located between the guiding head and the implanting instrument fixing head for placing the implanting instrument
  • the installation section has a thickened layer of the pipe wall on the outer circumference of the installation section.
  • the gap between the implanted device and the mounting section can be filled, overcoming the floating phenomenon existing between some parts of the implanted device and the mounting section, and avoiding the large gap of the conveying system during cornering. Exist and bend. Due to the structural difference of different implanted instruments, the position and size of the gap between the mounting and the mounting section are also different. Therefore, the position, shape and thickness of the thickened layer of the tube wall can be determined according to the structure of the specific implanted device. Set it to match the corresponding gap. In order to ensure the flexibility of the conveying system, the thickened layer of the pipe wall may be made of a material having better elasticity such as silicone or polyurethane.
  • the installation manner of the thickened layer of the pipe wall is not strictly limited, and the thickened layer of the pipe wall is integrally formed with the installation section or fixedly disposed outside the installation section.
  • At least one end of the thickened layer of the tube wall has a tapered shape whose outer diameter gradually decreases.
  • the tapered structure gradually transitions the outer diameter of the thickened layer of the tube wall to better fill the suspended position between the implanted device and the mounting section, and can avoid damage to the implanted device without affecting the release of the implanted device.
  • distal end of the sheath tube, the traction wire, the rib, etc. mentioned in the present invention refers to the end of the delivery system away from the operating handle, the sheath tube, the traction wire, the reinforcing rib, etc.
  • the proximal end refers to the end of the delivery system that is adjacent to the operating handle.
  • the Chinese Patent Publication No. CN102743196A discloses a composite pipe comprising an inner layer, a reinforcing layer and an outer layer which are sequentially disposed, and a reinforcing rib is provided on the reinforcing layer to enhance the radial force of the composite pipe.
  • the invention changes the design idea, uses the rib to play the role of self-positioning and bending, and makes reasonable setting of the traction wire and the rib, improves the controllability of the bending direction of the distal end of the sheath tube, and the doctor can conveniently pull the sheath through the traction wire. The distal end bends and moves to the target direction or locus, reducing the difficulty of surgery.
  • the sheath of the present invention has good bending resistance and improves safety.
  • FIG. 1 is a schematic structural view of an adjustable curved sheath tube of the present invention
  • Figure 2 is a cross-sectional view of the adjustable curved sheath tube of Figure 1 taken along the line A-A;
  • Figure 3 is a state diagram of the distal end of the adjustable curved sheath tube shown in Figure 1 when bent;
  • FIG. 4 is a schematic structural view showing another arrangement of the traction wire and the reinforcing rib in the adjustable curved sheath tube shown in FIG. 1;
  • Figure 5 is a schematic structural view of a sheath tube provided with a reinforcing rib and two traction wires according to the present invention
  • Figure 6 is a schematic structural view of a sheath tube provided with a reinforcing rib and a pulling wire according to the present invention
  • FIG. 7 is a schematic structural view of a sheath tube provided with two reinforcing ribs and one pulling wire according to the present invention.
  • FIG. 8 is a schematic structural view of another sheath tube provided with two reinforcing ribs and one pulling wire according to the present invention.
  • Figure 9 is a schematic structural view of a second embodiment of the adjustable curved sheath tube of the present invention.
  • Figure 10 is a schematic structural view of a conveying system of the present invention.
  • Figure 11 is a view showing the structure of a prior art aortic valve replacement device
  • Fig. 12 is a schematic view showing the structure of the aortic valve replacement device shown in Fig. 11 when it is loaded into a delivery system in the prior art.
  • Figure 13 is a schematic view showing the structure of the aortic valve replacement device shown in Figure 11 when it is loaded into the delivery system of the present invention.
  • Figure 14 is a schematic view showing the structure of the delivery system of the present invention passing through the aortic arch
  • Figure 15 is an enlarged view of the aortic arch portion of Figure 14;
  • Figure 16 is a cross-sectional view taken along line B-B of Figure 15;
  • Figure 17 is a schematic view showing the structure of the distal end of the sheath tube moving toward the center of the blood vessel after the delivery system of the present invention passes through the aortic arch;
  • Figure 18 is a schematic view showing the structure of the aortic valve replacement device after the delivery system of the present invention travels to the implantation site.
  • FIG. 1 shows the structure of a first embodiment of the adjustable curved sheath of the present invention, including an expanded section 102 and a tubular body 101 that are in communication.
  • the inflation section 102 is a tubular structure. During the interventional procedure, the inflation section 102 can pre-compress the implanted instrument so that the implanted instrument is in a compressed state until it is advanced to the implantation site, and the expansion section should have a certain radial direction.
  • the elastic force and axial support force, while the inner wall of the expansion section should be as smooth as possible to facilitate the release and recovery of the implanted device.
  • the tube body 101 is in communication with the expansion section 102, and the tube body 101 has a smaller diameter than the expansion section 102.
  • two channels 103 are defined in the tube wall of the tube body 101 in the axial direction.
  • Each of the channels 103 is provided with a pulling wire 104, and the pulling wire 104 can slide in the channel 103.
  • the distal end of the traction wire 104 is secured to the distal end of the tubular body 101, and the proximal end of the traction wire 104 extends along the respective passageway from the tubular body 101 to the control handle.
  • Two strip-shaped reinforcing ribs 105 are further disposed in the tube wall of the tubular body 101 in the axial direction.
  • the two reinforcing ribs 105 are located on opposite sides of the axial center of the tubular body 101, and from the distal end of the tubular body 101 The portion extends to the proximal end.
  • the tubular body 101 includes an inner layer 106, a reinforcing layer 107, and an outer layer 108 in this order from the inside to the outside.
  • the inner layer 106 and the outer layer 108 may be made of the same or different polymer lubricating materials.
  • the inner layer 106 may be made of a polytetrafluoroethylene material
  • the outer layer 108 may be made of a material such as polyethylene or polyurethane.
  • the reinforcing layer 107 is a steel tube braided spring tube structure, and the spring tube structure not only has a certain axial supporting force of the sheath tube, but also has good bending flexibility, so that the radial flexibility of the sheath tube is better, and in the present invention, strengthening
  • the ribs 105 can be placed against the reinforcing layer 107.
  • the ribs 105 are spaced apart from the pulling wire 104.
  • the two reinforcing ribs not only enhance the tensile strength of the pipe body, but also improve the axial support strength of the pipe body, ensure the pushing property of the sheath pipe, and at the same time, locate the bending direction of the pipe body, and the sheath pipe is in two reinforcing ribs.
  • the radial direction of the line ie, the z-axis direction shown in Figure 1 is not easily bent.
  • the sheath will be adaptive in two The vertical direction of the rib connection (ie, the y-axis direction shown in FIG. 1) is bent, and FIG.
  • FIG 3 shows the state when the distal end of the sheath is bent, after the sheath is traversed through the curved portion of the blood vessel.
  • the sheath will adaptively bend the flexible direction toward the center of the blood vessel, and the traction wire and the reinforcing ribs are spaced apart in the circumferential direction of the tubular body. At this time, the traction wire is directly pulled, and the distal end of the sheath can be made to the blood vessel.
  • the center is curved.
  • the traction wire When setting the traction wire, the traction wire should avoid excessively close to the reinforcing rib, otherwise it is necessary to apply a large pulling force to the traction wire to be able to pull the distal end of the sheath to bend, which is difficult to operate.
  • the angle A between one of the pulling wires 104 and the center of any one of the reinforcing bars 105 is not less than 30°, when the angle between the center of any one of the pulling wires and any one of the reinforcing bars is At 90° (Fig. 4), the pulling force required to pull the sheath at the distal end of the sheath is minimal and easy to control.
  • the number of reinforcing ribs is not limited to two, as shown in FIG. 5, the tube body Two channels 103 are opened in the axial direction of the tube wall 101, and each of the channels 103 is provided with a pulling wire. 104.
  • a reinforcing rib 105 is disposed in the tube wall of the tube body 101 in the axial direction.
  • the sheath tube is still not easy to be bent in the direction of the rib, and the self-positioning and turning can still be achieved, but in order to obtain better
  • the effect is that in the case where only one rib 106 is provided, the rib 106 can be adaptively thickened (compared to the case where two ribs are provided).
  • FIGS. 6 and 7 show the structure of the pipe body when a pulling wire is disposed.
  • the pipe wall of the pipe body 101 is opened in the axial direction.
  • a passage 103 is provided with a pulling wire 104 in the passage 103.
  • a reinforcing rib 105 is disposed in the pipe wall of the pipe body 101 in the axial direction.
  • the structure of the pipe body shown in Fig. 7 is similar to that of Fig. 6, except that two reinforcing ribs 105 are provided in the pipe wall of the pipe body 101 in the axial direction, and the two reinforcing ribs are in the axial center of the pipe body.
  • the center angle of the two ribs 105 is 180°.
  • the center angle of the two ribs 105 can also be less than 180°, as shown in FIG.
  • the center angle of the rib is about 130°.
  • the connecting direction (m and n) of each rib and the axis of the pipe body in the radial direction is not suitable for bending. Therefore, the pulling wire should be avoided in the rib and the axis.
  • Figure 9 shows a second embodiment of the adjustable curved sheath tube of the present invention.
  • This embodiment is similar to the first embodiment, except that the expansion section 102 and the tube body 101 are thickened by a transition.
  • the segments 109 are connected, and the outer wall of the transition portion 109 and the expansion portion 102 and the tube body 101 are smoothly transitioned, and the distal end of the reinforcing rib 104 extends and is fixed in the transition portion 109.
  • the dotted line in Figure 9 illustrates the expansion section 102 and the tube in the existing sheath. 101
  • the structure of the joint portion, the expansion section 102 and the pipe body 101 are directly butted together, and the joint portions of the two are weak and easy to bend, and the defect can be overcome by setting the transition section.
  • the present invention also provides a delivery system comprising a sheath 100, a sheath core 200, and a control handle (not shown) that is fixed to the proximal end of the sheath tube and the proximal end of the sheath core.
  • the sheath core includes a core tube 201, a guide head 202, and an implant device fixation head 203.
  • the guiding head 202 is fixedly connected to the distal end of the core tube 201, and the implanting instrument fixing head 203 is provided with a through hole and a positioning groove at the distal end of the core tube 201, and a conventional structure can be used, for example, refer to the publication number. CN101953724A, the Chinese patent document entitled "Stent Fixing Head for Loading Artificial Valve Replacement Device".
  • the core tube 201 is a hollow tube with a through hole, and the portion of the core tube 201 between the guiding head 202 and the implant device fixing head 203 is a mounting section 204 for placing an implant device.
  • the outer peripheral fixing sleeve of the mounting section 204 is provided with a thickened layer 205 of the pipe wall.
  • the thickened layer 205 of the tube wall is used to fill the hanging portion between the implanted device and the mounting section. Due to the difference between the implanted instruments, the suspended portion, the hanging size, the shape, etc. between the implanted device and the mounting section are thereby It will also vary, so the shape of the thickened layer of the tube wall, the location of the set, and the size of the thickened layer of the tube wall can be set according to the specific implant device.
  • the thickened layer 205 of the tube wall can be made of a material having good elasticity, such as silicone, polyurethane and the like.
  • the thickened layer and the installation section of the pipe wall can be processed by integral molding.
  • the sheath 100 is sheathed on the outside of the sheath core 200 and slidable relative to the sheath core 200 to release or recover the implant device.
  • the sheath tube 100 can adopt the structure as described above.
  • the invention is now further illustrated in connection with aortic valve replacement.
  • Figure 11 shows the structure of a prior art aortic valve replacement device consisting of a stent and a prosthetic valve (not shown) secured within the stent, the stent being connected by abutting stent 401, valve stent 402, and flow in sequence.
  • the inlet stent 403 is formed into a mesh-like cylindrical structure, and the flow-advance stent 403 is covered with a membrane, and the prosthetic valve is sewn at the valve stent.
  • the top edge of the aortic stent 401 is provided with three lock members 404, the height of which may be the same or different.
  • the stent is in a collapsed state when it is not released, and is a dense tubular structure formed by laser cutting of a tube of a memory metal material.
  • the aortic valve replacement device is first loaded on the delivery system, firstly, the implanted instrument fixation head of the sheath core is extended out of the sheath tube, and after the guide head passes through the tubular aortic valve replacement device, the aortic valve replacement device is used. It is fixed in the positioning groove of the outer wall of the implanted instrument fixing head, and then the sheath tube is completely wrapped around the aortic valve replacement device.
  • Figure 13 shows the state of the delivery system of the present invention after it has been loaded into the aortic valve replacement device, at which point the expansion section 102 of the sheath 100 is placed over the guide head 202 of the sheath core 200, the mounting section 204, and the implant fixture head. Outside of the 203, the aortic valve replacement device 400 is placed over the sheath core mounting section 204, the entire aortic valve replacement device 400 is compressed by the inflation section 102, and the wall thickened layer 205 is located approximately in the prosthetic valve replacement device prosthetic valve In the above part, compared with the existing delivery system without the thickened layer of the tube wall (Fig.
  • the aortic stent 401 is relatively loose between the sheath core 500 and the sheath core 500.
  • the gap, the space between the lock member 404 of the bracket and the sheath core 500 is obvious.
  • the thickened layer of the tube wall of the present invention just fills the gap described above, and the implanting device 400 and the sheath core are closely matched, thereby effectively preventing the folding phenomenon of the conveying system during the turning, which greatly reduces the deformation of the sheath tube. Failure to release/recover the device, damage to the sheath reinforcement, and other risks to the patient.
  • the delivery system After loading of the aortic valve replacement device, the delivery system, along with the aortic valve replacement device, is delivered to the valve implantation site along the established guidewire track.
  • the femoral artery is firstly puncture, the abdominal aorta, the descending aorta, and then the aortic arch, and the aortic valve position of the aortic root is retrogradely performed for valve replacement.
  • the physician pushes the sheath tube and the sheath core through the control handle to advance along the guide wire.
  • the sheath tube itself has good compliance and can adaptively adjust the bending direction to Adhering to the vasculature of the human body, as the sheath bends outward, the sheath always abuts against the vessel wall (as shown in Figures 14 and 15), and the aortic arch 300 is the distal end of the sheath to the implantation site.
  • the sheath will adaptively be in the two ribs.
  • the vertical line of the line is bent.
  • the state of the distal end of the sheath in the blood vessel is as shown in Fig. 16 (the tube body is provided with two traction wires and two reinforcing ribs on the cross section of the tube body).
  • the angle between the center of any one of the traction wires and the ribs is 90°. It can be seen that the sheath 100 abuts against the blood vessel wall 301, and the traction wire 104 faces the center of the blood vessel, that is, the direction in which the sheath is easy to bend The center of the blood vessel, at this time, directly Pulling the traction wire 104, as shown in Fig.
  • the sheath is easily moved to the central position of the blood vessel (M direction), and the sheath and the sheath core are continuously pushed to pass through the valve center O of the aortic valve 302.
  • the sheath tube is moved away from the guiding head, and the aortic valve replacement device can be released (as shown in FIG. 18).
  • the aortic valve replacement device is completely released, the sheath core and the sheath tube are recovered, and the main body is released.
  • the arterial valve replacement device is opened under the action of body temperature and fixed at the implantation site to replace the function of the native valve.

Abstract

一种可调弯鞘管（100）及具有该可调弯鞘管（100）的输送系统，所述可调弯鞘管（100）包括管体（101），所述管体（101）具有远端和近端，所述管体（101）的管壁内沿轴向设有加强筋（105）和牵引丝（104），所述牵引丝（104）的远端固定于所述管体（101）的远端，所述牵引丝（104）的近端延伸出管体（101）用于与操作手柄相连。所述输送系统，包括所述可调弯鞘管（100）、置于所述可调弯鞘管（100）内的鞘芯（200）以及与所述可调弯鞘管（100）和鞘芯（200）近端固定的操作手柄，牵引丝（104）的近端固定在所述操作手柄上。通过所述可调弯鞘管（100），有利于所述可调弯鞘管（100）远端方向的调节，提高了所述可调弯鞘管（100）远端弯曲方向的可控性，能够容易的控制所述可调弯鞘管（100）的远端向病变部位移动。

Description

可调弯鞘管及具有该可调弯鞘管的输送系统 技术领域
本发明属于医疗器械技术领域，尤其涉及一种可调弯鞘管及具有该可调弯鞘管的输送系统。
 背景技术
介入手术对人体造成的创伤小，侵害性少，是近些年迅速兴起并推广的医疗技术，通常需要借助介入型诊疗鞘管（如输送鞘管、导引鞘管等），在患者体内的病变位置与外界操作端之间建立通道，以导入诊疗器械、药物、植入器械等至病变部位。介入型诊疗鞘管具有远端和近端，远端可进入人体的脉管系统，近端与操作手柄相连接，在使用时，通常是预先建立导丝轨道，将鞘管的远端或连通其他辅助器械穿刺进入血管内，医师通过操作手柄控制鞘管的远端沿着事先建立好的导丝轨道行进至病变部位释放药物、器械等。
基于人体脉管系统迂回曲折的特性以及远距离操作的考虑，鞘管通常应具备足够的轴向与径向支撑力以及良好的顺应性，在达到病变部位以前，通过医师的推送，鞘管自身具备的顺应性能够使鞘管的远端在沿着导丝轨道行进的过程中，自适应的调整弯曲方向以顺应人体的脉络。由于血管内血流的影响，鞘管通常是沿着血管壁前进，在前期，这对鞘管的行进路线并无太大的影响，但是在药物、器械释放时，需要鞘管的远端对准病变部位，显然的，此时必须对鞘管的远端的方向进行调节和控制，使其移动至目标位置。
以心脏瓣膜置换术为例，人体的心脏瓣膜位于血管的中央位置，当需要对心脏瓣膜置换时，鞘管的远端需到达瓣膜的中心，再将携带的心脏瓣膜置换装置释放，使心脏瓣膜置换装置代替自身的瓣膜行驶功能，由于鞘管是沿着血管壁前进的，因此在靠近病变位点时，就需要调整鞘管远端的方向，使其朝向瓣膜的中心移动，如主动脉瓣的直径约为26mm，而该处血管的直径显然大于主动脉瓣的直径，而通常鞘管远端的直径为7mm左右，那么至少应使鞘管的远端在血管的直径方向移动9mm左右。
一种解决办法是按照人体血管分布形状或者人体结构对导管的远端进行定形加工，结合不同的形状、结构定制不同形状的导管来满足在迂回的血管内到达病变部位的需求。如美国专利US2003144657披露了一种导管组件，该导管组件使用带有预成形远端的外导管和带有预成形的内导管，内、外导管的相对转动和延伸提供了导管组件远端末端的可调整形状，以改进通过右心房的定位和用导管插入冠状窦。但是这并不能与个体化的生理解剖结构一一相适应，很容易影响手术结果。
目前，通常采用的解决方案是运用远端可调弯的鞘管，通常是有一根或多根牵引丝（也有称拉线），其远端固定于鞘管的远端，并一直延伸至鞘管近端，与鞘管近端手柄上的调节机构相连接，该牵引丝可在导管内滑动，以允许医生主动的改变导管曲率，将鞘管远端弯曲，引导其转弯行进到目标部位。
如公开号为CN102921089A的中国专利文献公开了一种用于介入治疗头部可控弯曲导管，多腔导管头部连接有主导管软头，多腔导管的尾部通过连接件与延长管连接，延长管外设有手柄，手柄内活动连接有手柄滑动装置，滑动装置与延长管挤压配合，滑动装置的上下两端延伸至手柄的壳体外，滑动装置的上下两侧分别连接有一根牵引丝，牵引丝的另一端穿过多腔导管和主导管软头上同侧的辅腔固定连接在主导管软头的头部，延长管另一端延伸到手柄外，连接有接头。在导管进入体内后，根据血管或者相关部位的结构，通过手柄控制牵引丝，牵引丝在受到手柄滑动装置的牵引力拉动导管远端的主导管软头，主导管软头受到牵引丝的拉力往回弯曲，从而实现方向的调节。
上述结构的导管（即鞘管）虽然允许医生主动改变导管曲率，实现了导管远端360°的任何角度弯曲，但在实际的手术操作中，由于鞘管远端角度的偏转，远端可弯曲的方向和目标位置之间配合需再次确认调整，而介入治疗的映像往往是平面投影映像，大大增加了了实际操作过程中对医生经验的依赖性。
因此，有必要提供一种鞘管，使医生容易的操纵方向以到达患者体内所希望的位置。
 技术问题
本发明提供了一种可调弯鞘管，有利于鞘管远端方向的调节，提高了鞘管远端弯曲方向的可控性，能够容易的控制鞘管的远端向病变部位移动。
 技术解决方案
一种可调弯鞘管，包括管体，所述的管体具有远端和近端，所述管体的管壁内沿轴向设有加强筋和牵引丝，所述牵引丝的远端固定于所述管体的远端，所述牵引丝的近端延伸出管体用于与操作手柄相连。
加强筋的设置定位了管体的折弯方向，在加强筋与管体轴线沿径向的连线方向上，鞘管不易折弯，当鞘管沿着导丝在血管中弯曲行进时，鞘管将自适应的以最易折弯的侧边完成弯曲过程，即在加强筋与管体轴线连线的垂线方向折弯，以顺应人体的脉管系统行进，当鞘管循迹穿越血管的弯曲部位后，鞘管会自适应的将易弯曲的方向朝向血管的中心，此时拉动牵引丝，即可使鞘管的远端向血管的中心弯曲、移动。
加强筋的数目不宜过多，可设置一条或两条。
当加强筋为一条时，作为其中一种选择方式，所述的牵引丝为一根，所述的加强筋为一条。一根牵引丝只能够实现单向调弯，当需要将鞘管向相背于牵引丝的方向调弯时，可将鞘管旋转约180°后，再拉动牵引丝。在设置牵引丝时，牵引丝应避免过度靠近加强筋，否则需对牵引丝施加较大的拉力才能够牵动鞘管的远端折弯，操作难度较大。优选的，在管体的任意截面上，加强筋与牵引丝的中心夹角为30~150°。优选的，加强筋与牵引丝的中心夹角为80~100°。
本领域人员可以理解，上述管体的截面是指管体的径向截面，加强筋与牵引丝的中心夹角即是加强筋、牵引丝与截面中心的夹角。
作为另一种选择方式，所述的加强筋为一条，所述的牵引丝为两根，两根牵引丝分布于加强筋与管体轴线沿径向的连线的两侧。设置两根牵引丝能够实现双向调弯。
加强筋为一条，牵引丝为两根时，在管体的任意截面上，加强筋与任意一根牵引丝的中心夹角为30~150°。优选的，加强筋与任意一根牵引丝的中心夹角为80~100°。
一根加强筋可能导致鞘管在行进过程中不停的扭转，为克服该缺陷，加强筋可设置为两条，另外，两根加强筋对鞘管弯曲方向的限定也能更加严格。
当加强筋为两条时，作为其中一种选择方式，所述的牵引丝为一根，所述的加强筋为两条。
加强筋为两条，牵引丝为一根时，两条加强筋处在所述管体的轴心对侧，在管体的任意截面上，任意一根加强筋与牵引丝的中心夹角为30~150°。优选的，任意一根加强筋与牵引丝的中心夹角为80~100°。
作为另一种选择方式，所述的牵引丝为两根，所述的加强筋为两条，所述的牵引丝与加强筋在管体的周向上间隔分布。
当牵引丝为两根，加强筋为两条时，两条加强筋处在所述管体的轴心对侧，在管体的任意截面上，任意一根加强筋与其中一根牵引丝的中心夹角为30~150°。优选的，任意一根加强筋与其中一根牵引丝的中心夹角为80~100°。
两条加强筋处在所述管体的轴心对侧即两条加强筋处在所述管体的两相对侧，这样，鞘管在两条加强筋沿径向的连线方向上不易折弯，只能在两条加强筋连线的中垂线方向折弯，拉动牵引丝时，鞘管的远端必然且更容易的朝最易弯曲的方向（牵引丝的方向）弯曲。
当然，两条加强筋也可不相对布置。在管体的任意截面上，两根加强筋的中心夹角小于180°，牵引丝处于任意加强筋与管体轴线沿径向的连线的一侧。这样，鞘管在每根加强筋与管体轴线沿径向的连线方向均不宜弯曲，因此，在设置牵引丝时，应避免牵引丝分布在任意一条加强筋与管体轴线沿径向的连线方向。
所述的可调弯鞘管还包括与所述管体连通的膨胀段，所述膨胀段与管体的远端一侧相连且用于容纳植入器械。
所述膨胀段与管体之间通过增厚的过渡段相连接，且该过渡段的外壁与所述膨胀段和管体均平滑过渡，所述加强筋的远端延伸并固定在该过渡段内。管体与膨胀段相连接的部位为薄弱环节，过渡段可避免调弯时该处打死折，影响植入器械的释放，另外，在行进过程中，膨胀段内容纳有植入器械，并使植入器械处于压缩状态，因此膨胀段具有较强的径向支撑力，且植入器械在一定程度上影响了膨胀段的柔顺性，加强筋的远端固定在该过渡段内可避免加强筋对其顺应性产生影响。
本发明还提供了一种输送系统，包括所述的可调弯鞘管、置于所述可调弯鞘管内的鞘芯以及与所述可调弯鞘管和鞘芯近端固定的操作手柄，牵引丝的近端固定在所述的操作手柄上。
所述的鞘芯包括芯管，所述芯管的远端固定有引导头和介入器械固定头，所述芯管处于引导头和植入器械固定头之间的部位为用于放置植入器械的安装段，所述安装段的外周设有管壁加厚层。
通过设置管壁加厚层，能够填充植入器械与安装段之间的间隙，克服植入器械某些部位与安装段之间存在的悬空现象，避免了输送系统在转弯时因较大空隙的存在而弯折。由于不同植入器械的结构差异，其与安装段之间间隙存在的位置、大小等也有所差别，因此，管壁加厚层的位置、形状、厚度等可根据具体的植入器械的结构进行设置，使其与相应的间隙相适应。为保证输送系统的柔顺性，所述管壁加厚层可采用有机硅、聚氨酯等弹性较好的材料制成。
对于管壁加厚层的安装方式并没有严格限制，所述管壁加厚层与安装段一体成型或固定套设在安装段的外部。
所述管壁加厚层的至少一端为外径逐渐减小的锥形。锥形结构使管壁加厚层的外径逐渐过渡，能够更好的填充植入器械与安装段之间的悬空位置，且可以避免损伤植入器械，同时也不影响植入器械的释放。
本领域人员可以理解，在本发明中所提及的鞘管、牵引丝、加强筋等的远端是指在输送系统中，远离操作手柄的一端，所述鞘管、牵引丝、加强筋等的近端是指在输送系统中，靠近操作手柄的一端。
 有益效果
与现有技术相比，本发明的有益效果为：
（1）公开号为CN102743196A的中国专利文献公开了一种复合管，包括依次设置的内层、加强层和外层，通过在加强层设置加强筋以增强复合管的径向受力，而本发明改变设计思路，利用加强筋发挥自定位调弯的作用，并对牵引丝和加强筋进行合理设置，提高了鞘管远端弯曲方向的可控性，医生可方便的通过牵引丝将鞘管远端弯曲、移动至目标方向或位点，降低了手术难度。
（2）本发明的鞘管的抗折性好，提高了安全性。
 附图说明
图1为本发明可调弯鞘管的结构示意图；
图2为图1所示的可调弯鞘管沿A-A方向的剖视图；
图3为图1所示的可调弯鞘管远端弯曲时的状态图；
图4为图1所示的可调弯鞘管中另一种牵引丝与加强筋布置方式的结构示意图；
图5为本发明设有一条加强筋和两根牵引丝的鞘管的结构示意图；
图6为本发明设有一条加强筋和一根牵引丝的鞘管的结构示意图；
图7为本发明设有两条加强筋和一根牵引丝的鞘管的结构示意图；
图8为本发明设有两条加强筋和一根牵引丝的另一种鞘管的结构示意图；
图9为本发明可调弯鞘管的第二种实施方式的结构示意图；
图10为本发明输送系统的结构示意图；
图11为现有技术中主动脉瓣膜置换装置的结构；
图12为现有技术中，图11所示的主动脉瓣膜置换装置装载入输送系统时的结构示意图。
图13为图11所示的主动脉瓣膜置换装置装载入本发明的输送系统时的结构示意图。
图14为本发明的输送系统穿越主动脉弓的结构示意图；
图15为图14中主动脉弓部位的放大图；
图16为图15沿B-B方向的剖视图；
图17为本发明的输送系统穿越主动脉弓后，鞘管的远端向血管中心移动的结构示意图；
图18为本发明的输送系统行进至植入位点后释放主动脉瓣膜置换装置的结构示意图。
 本发明的实施方式
下面结合具体实施例对本发明作进一步阐释。
图1显示了本发明可调弯鞘管的第一种实施方式的结构，包括依次连通的膨胀段102和管体101。
膨胀段102为管状结构，在介入手术中，膨胀段102能够预压缩植入器械，使植入器械处于被压缩状态直至行进到植入位点后将其释放，膨胀段应具备一定的径向的弹力和轴向的支撑力，同时膨胀段内壁应尽可能的光滑，以方便释放、回收植入器械。
管体101与膨胀段102相连通，该管体101的口径小于膨胀段102。如图2所示，管体101的管壁内沿轴向方向开设有两个通道103，每个通道103内均设有一根牵引丝104，牵引丝104能够在通道103内滑动，这两根牵引丝104的远端固定在管体101的远端端部，牵引丝104的近端沿着各自的通道延伸出管体101与控制手柄相连。
管体101的管壁内沿轴向方向还设有两根条形的加强筋105，这两根加强筋105处在管体101轴心的两相对侧，且从管体101的远端端部延伸至近端端部。通常，沿径向方向，管体101由内至外依次包括内层106、加强层107和外层108。内层106和外层108可采用相同或者不同的高分子润滑材料制成，如内层106可采用聚四氟乙烯材料，外层108可采用聚乙烯、聚氨酯等材料。加强层107为钢丝编织的弹簧管结构，弹簧管结构不仅使鞘管具备一定的轴向支撑力，同时，其弯曲柔韧性能好，使得鞘管径向的柔顺性更好，本发明中，加强筋105可紧贴加强层107设置。
在管体101的周向上，加强筋105与牵引丝104间隔分布。
两条加强筋不仅增强了管体的抗拉强度，提高管体的轴向支撑强度，保证了鞘管的推送性，同时，还定位了管体的折弯方向，鞘管在两条加强筋沿径向的连线方向（即图1中所示的z轴方向）上不易折弯，当鞘管沿着血管壁行进在曲折复杂的人体脉管系统中，鞘管会自适应的在两条加强筋连线的垂线方向（即图1中所示的y轴方向）折弯，图3示出了鞘管的远端弯曲时的状态，当鞘管循迹穿越血管的弯曲部位后，鞘管会自适应的将易弯曲的方向朝向血管的中心，而牵引丝与加强筋在管体的周向上间隔分布，此时直接拉动牵引丝，即可使鞘管的远端向血管的中心弯曲。
在设置牵引丝时，牵引丝应避免过度靠近加强筋，否则需对牵引丝施加较大的拉力才能够牵动鞘管的远端折弯，操作难度较大。通常，在管体的任意截面上，其中一根牵引丝104与任意一根加强筋105的中心夹角A不小于30°，当任意一根牵引丝与任意一根加强筋的中心夹角为90°时（如图4），此时牵引丝拉动鞘管远端折弯时所需的拉力最小，极易控制。
值得注意的是，在本发明中，加强筋的数目并不仅限于两条，如5所示，管体 101的管壁内沿轴向方向开设有两个通道103，每个通道103内均设有一根牵引丝 104，管体101的管壁内沿轴向方向设有一根加强筋105，鞘管在加强筋的方向上仍然不易发生折弯，仍可达到自定位调弯的目的，但为了取得更好的效果，在仅设置一根加强筋106的情况下，该加强筋106可适应性的加粗（与设置两根加强筋的情况相比）。
另外，牵引丝也可以仅设置为一根，图6和图7示出了设置一根牵引丝时管体的结构，如图6所示，管体101的管壁内沿轴向方向开设有一个通道103，通道103内设有一根牵引丝104，管体101的管壁内沿轴向方向设有一根加强筋105。图7示出的管体的结构与图6类似，不同之处在于，管体101的管壁内沿轴向方向设有两根加强筋105，这两根加强筋处于管体轴心的两相对侧，即在管体的任意截面上，两根加强筋105的中心夹角为180°，当然，两根加强筋105的中心夹角也可小于180°，如图8所示，两根加强筋的中心夹角约为130°，此时，每根加强筋与管体轴线沿径向的连线方向（m和n）均不宜弯曲，因此，牵引丝应避免处在加强筋与轴线沿径向的连线方向。显然的，牵引丝的数量并不影响加强筋的自定位调弯的功能，由于一根牵引丝只能够实现单向调弯，当需要向相背于牵引丝的方向调弯时，可通过操作手柄将鞘管旋转180°左右后，再拉动牵引丝。
图9示出了本发明可调弯鞘管的第二种实施方式，本实施方式与第一种实施方式类似，不同的之处在于：膨胀段102与管体101之间通过增厚的过渡段109相连接，且该过渡段109的外壁与膨胀段102和管体101均平滑过渡，加强筋104的远端延伸并固定在过渡段109内。图9中虚线示意了现有鞘管中膨胀段102与管体 101连接部位的结构，膨胀段102与管体101直接对接在一起，两者的连接部位薄弱，易弯折，而通过设置过渡段则能够克服该缺陷。
值得注意的是，在本发明不同实施方式之间，除非明显不可组合外，各实施方式的技术特征均可相互进行借鉴。
参见图10，本发明还提供了一种输送系统，包括鞘管100、鞘芯200以及与鞘管的近端、鞘芯的近端相固定的控制手柄（图中未显示）。
鞘芯包括芯管201、引导头202和植入器械固定头203。
引导头202与芯管201的远端端部固定连接，植入器械固定头203带有通孔和定位槽，位于芯管201的远端，具体可采用常规的结构，如可参照公开号为CN101953724A，发明名称为“用于装载人造瓣膜置换装置的支架固定头”的中国专利文献。
芯管201为带有通孔的空心管，芯管201处于引导头202和植入器械固定头203之间的部位为用于放置植入器械的安装段204。该安装段204的外周固定套设有管壁加厚层205。
管壁加厚层205用于填充植入器械与安装段之间的悬空部位，由于植入器械之间存在的差异，由此植入器械与安装段之间的悬空部位、悬空大小、形状等也会有所不同，因此，管壁加厚层的形状、设置的部位以及管壁加厚层的尺寸均可以根据特定的植入器械进行设置。
为保证输送系统植入器械部位的柔顺性，管壁加厚层205可采用弹性较好的材料制成，如有机硅、聚氨酯等。
此外，管壁加厚层与安装段除可采用固定套装的安装方式外，管壁加厚层与安装段还可采用一体成型的方式进行加工。
鞘管100套在鞘芯200的外部，可相对鞘芯200滑动，对植入器械进行释放或回收，鞘管100可采用如上所述的结构。
现结合主动脉瓣膜置换术进一步阐释本发明。
图11显示了现有的一种主动脉瓣膜置换装置的结构，由支架和固定在支架内的假体瓣膜（未显示）构成，支架为由依次连接的主动脉支架401、瓣膜支架402和流进道支架403构成的网状的筒形结构，流进道支架403带有覆膜，假体瓣膜缝制在瓣膜支架处。主动脉支架401的顶沿设有三个锁件404，这三个锁件的高度可相同或者不相同。支架在未释放时是收拢的状态，为致密的管状结构，通过记忆金属材料的管材经过激光切割加工而成。
术时，先将主动脉瓣膜置换装置装载在输送系统上，首先使鞘芯的植入器械固定头伸出鞘管，引导头穿过管状的主动脉瓣膜置换装置后，将主动脉瓣膜置换装置固定在植入器械固定头外壁的定位槽中，再将鞘管完全包裹住主动脉瓣膜置换装置。
图13示出了本发明的输送系统装载入主动脉瓣膜置换装置后的状态，此时，鞘管100的膨胀段102套在鞘芯200的引导头202、安装段204和植入器械固定头203的外部，主动脉瓣膜置换装置400套装在鞘芯的安装段204，整个主动脉瓣膜置换装置400被膨胀段102压缩，而管壁加厚层205大致位于主动脉瓣膜置换装置的假体瓣膜以上部位，与未设有管壁加厚层的现有输送系统相比（图12），由于未设有管壁加厚层，主动脉支架401部位与鞘芯500之间呈现较松稀的空隙，支架的锁件404部位与鞘芯500之间悬空600明显，弯曲时容易从悬空部位或稀疏部位产生弯折，很多时候会引起鞘管变形出现打死折现象。而本发明的管壁加厚层正好填充了上述的间隙，植入器械400与鞘芯之间紧密配合，有效防止了输送系统在转弯时该部位出现打折现象，大大降低了鞘管打折后造成器械释放/回收失败，鞘管加强层断裂刺出等对患者造成生命危险的风险。
主动脉瓣膜置换装置装载完成后，将输送系统连同主动脉瓣膜置换装置沿着已经建立好的导丝轨道，输送至瓣膜植入位点。一般先从股动脉穿刺，经腹主动脉、降主动脉，再穿过主动脉弓，逆行至主动脉根部的主动脉瓣位置进行瓣膜的置换。整个过程中，医师通过控制手柄推送鞘管和鞘芯使其沿着导丝前进，虽然人体的脉管系统曲折复杂，但是鞘管自身具有良好的顺应性，能够自适应的调整弯曲方向，以顺应人体的脉管系统而向前行进，由于鞘管弯曲张力向外，鞘管始终紧靠着血管壁行进（如图14、图15所示），主动脉弓300是鞘管远端到达植入位点后经历的最后一个大弯曲，由于鞘管的管体内设置有加强筋，定位了管体的折弯方向，在鞘管的远端经过主动脉弓时，鞘管会自适应的在两条加强筋连线的垂线方向折弯，当穿过主动脉弓后，鞘管的远端在血管内的状态如图16所示（以管体设有两根牵引丝和两条加强筋，管体截面上，任意一根牵引丝与加强筋的中心夹角为90°为例示意），可见鞘管100紧靠血管壁301，且牵引丝104正对血管的中心，即鞘管易弯曲的方向正对血管的中心，此时，直接牵动牵引丝104，如图17所示，鞘管便容易的向血管的中心位置移动（M方向），继续推动鞘管和鞘芯，便可使其穿过主动脉瓣302的瓣膜中心O，此时，使鞘管向远离引导头的方向移动，可将主动脉瓣膜置换装置释放（如图18所示），待主动脉瓣膜置换装置完全释放后，回收鞘芯、鞘管，释放的主动脉瓣膜置换装置在体温作用下涨开，固定在植入位点，替代自体瓣膜行使功能。

Claims (14)

  1. 一种可调弯鞘管，包括管体，其特征在于，所述的管体具有远端和近端，所述管体的管壁内沿轴向设有加强筋和牵引丝，所述牵引丝的远端固定于所述管体的远端，所述牵引丝的近端延伸出管体用于与操作手柄相连。
  2. 如权利要求1所述的可调弯鞘管，其特征在于，所述的牵引丝为一根，所述的加强筋为一条。
  3. 如权利要求2所述的可调弯鞘管，其特征在于，在管体的任意截面上，加强筋与牵引丝的中心夹角为30~150°。
  4. 如权利要求1所述的可调弯鞘管，其特征在于，所述的加强筋为一条，所述的牵引丝为两根，两根牵引丝分布于加强筋与管体轴线沿径向的连线的两侧。
  5. 如权利要求4所述的可调弯鞘管，其特征在于，在管体的任意截面上，加强筋与任意一根牵引丝的中心夹角为30~150°。
  6. 如权利要求1所述的可调弯鞘管，其特征在于，所述的牵引丝为一根，所述的加强筋为两条。
  7. 如权利要求6所述的可调弯鞘管，其特征在于，两条加强筋处在所述管体的轴心对侧，在管体的任意截面上，任意一根加强筋与牵引丝的中心夹角为30~150°。
  8. 如权利要求1所述的可调弯鞘管，其特征在于，所述的牵引丝为两根，所述的加强筋为两条，所述的牵引丝与加强筋在管体的周向上间隔分布。
  9. 如权利要求8所述的可调弯鞘管，其特征在于，两条加强筋处在所述管体的轴心对侧，在管体的任意截面上，任意一根加强筋与其中一根牵引丝的中心夹角为30~150°。
  10. 如权利要求6或8所述的可调弯鞘管，其特征在于，在管体的任意截面上，两根加强筋的中心夹角小于180°，牵引丝处于任意加强筋与管体轴线沿径向的连线的一侧。
  11. 如权利要求1所述的可调弯鞘管，其特征在于，还包括与所述管体连通的膨胀段，所述膨胀段与管体的远端一侧相连且用于容纳植入器械。
  12. 如权利要求11所述的可调弯鞘管，其特征在于，所述膨胀段与管体之间通过增厚的过渡段相连接，且该过渡段的外壁与所述膨胀段和管体均平滑过渡，所述加强筋的远端延伸并固定在该过渡段内。
  13. 一种输送系统，其特征在于，包括如权利1~12任一项所述的可调弯鞘管、置于所述可调弯鞘管内的鞘芯以及与所述可调弯鞘管和鞘芯近端固定的操作手柄，牵引丝的近端固定在所述的操作手柄上。
  14. 如权利要求13所述的输送系统，其特征在于，所述的鞘芯包括芯管，所述芯管的远端固定有引导头和介入器械固定头，所述芯管处于引导头和植入器械固定头之间的部位为用于放置植入器械的安装段，所述安装段的外周设有管壁加厚层。
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