WO2023125400A1 - 可调弯鞘管 - Google Patents

可调弯鞘管 Download PDF

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Publication number
WO2023125400A1
WO2023125400A1 PCT/CN2022/141889 CN2022141889W WO2023125400A1 WO 2023125400 A1 WO2023125400 A1 WO 2023125400A1 CN 2022141889 W CN2022141889 W CN 2022141889W WO 2023125400 A1 WO2023125400 A1 WO 2023125400A1
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WO
WIPO (PCT)
Prior art keywords
sheath
driving mechanism
pulling wire
tube
inner sheath
Prior art date
Application number
PCT/CN2022/141889
Other languages
English (en)
French (fr)
Inventor
王刚
黄广念
余文超
Original Assignee
深圳市健心医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202123447414.3U external-priority patent/CN217366195U/zh
Priority claimed from CN202111677346.1A external-priority patent/CN116407352A/zh
Application filed by 深圳市健心医疗科技有限公司 filed Critical 深圳市健心医疗科技有限公司
Publication of WO2023125400A1 publication Critical patent/WO2023125400A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters

Definitions

  • the invention relates to the technical field of medical instruments, in particular to an adjustable curved sheath tube.
  • Mitral valve disease is a common disease in the elderly population, which includes two common types of mitral valve regurgitation and mitral valve stenosis, of which mitral valve regurgitation is the most common. Intervention is required for moderate to severe mitral regurgitation. The traditional surgical treatment is open chest. With the support of extracorporeal circulation machine, the heart is opened for valve repair or replacement, but high-risk patients cannot tolerate it. The interventional therapy that has emerged in recent years has brought hope to high-risk patients with mitral regurgitation. Interventional therapy is generally to deliver instruments to the lesion site through a sheath to repair or replace the valve.
  • the sheath tube needs to be used in conjunction with the supporting delivery system, and the handle shell needs to be fixed on a support frame. Due to the variability and complexity of the internal structure of the heart, the sheath tube needs to be adjusted at multiple angles and directions to realize the instrument. Precise capture of leaflets.
  • the sheaths currently on the market are often unable to quickly reach the expected angle and position for complex lesions with twisted blood vessels, and need to be adjusted multiple times by rotating the handle of the device outside the body.
  • the handle when adjusting the sheath tubes currently on the market, the handle usually needs to be disassembled from the support frame, and then the handle device is rotated as a whole. The operation process is cumbersome, which greatly prolongs the operation time and increases the probability of complications for patients. .
  • the sheath needs to be bent at multiple angles and directions to achieve precise capture of the valve leaflets by the instrument.
  • the current adjustable bending sheath is generally one-way or two-way bending, and its bending direction is always in a plane, and it is impossible to achieve cross-plane bending. It is far from being able to meet the needs of doctors and patients, and has great limitations.
  • the present invention provides an adjustable curved sheath to at least solve one of the above technical problems.
  • an adjustable curved sheath including a sheath, a rotating mechanism, a housing disposed at the proximal end of the sheath, at least one driving mechanism disposed in the housing, and At least one pulling wire, the proximal end of the pulling wire is connected to the driving mechanism, the distal end of the pulling wire is connected to the distal end of the sheath, and the driving mechanism is used to pull and release the pulling wire to change the bending state of the sheath; at least part of the rotating mechanism extends into the housing and the rotating mechanism can rotate relative to the housing, and the rotating mechanism extending into the housing and the The sheath tube is connected to the driving mechanism, so that the sheath tube and the driving mechanism can rotate coaxially with respect to the casing under the drive of the rotating mechanism.
  • the pull wire connected thereto is released to change the bending state of the sheath.
  • the pulling wire is used to change the bending state of the sheath.
  • one of the pulling wires is connected to one of the driving mechanisms, and the other two pulling wires are connected to the other two.
  • the driving mechanisms are connected, and the two driving mechanisms are respectively used to pull and release the traction wires connected thereto so as to change the bending state of the sheath tube.
  • the rotating mechanism includes a rotating member, an inner sheath reinforcing tube and two inner sheath guide rods, the inner sheath reinforcing tube and the inner sheath guide rods are placed in the housing, and the sheath tube pass through the inner sheath reinforcing tube and be fixedly connected with the inner sheath reinforcing tube, both the inner sheath reinforcing tube and the inner sheath guide rod are connected with the rotating member, and the inner sheath guide rod passes through the Driving mechanism: the rotating member drives the sheath tube to rotate coaxially relative to the housing through the inner sheath reinforcing tube under the action of external force, and drives the driving mechanism to rotate relative to the housing through the inner sheath guide rod The body rotates coaxially.
  • the driving mechanism when both the driving mechanism and the pulling wire are provided with one, the driving mechanism includes a first driving mechanism, the pulling wire includes a first pulling wire, and the first driving mechanism includes The first active part, and the first slider linked with the first active part, the first slider is connected with the proximal end of the first traction wire, and the first slider is sleeved in the inner on the sheath reinforcement tube; the first slider can move along the inner sheath reinforcement tube driven by the first driving member, so that the first slider pulls and pulls the first pulling wire freed.
  • the first slider is sleeved on the two inner sheath guide rods, the rotating member rotates relative to the housing under the action of external force and drives the inner sheath reinforcing tube to drive the The sheath tube rotates coaxially, and the inner sheath guide rod drives the first sliding block and the first driving part to rotate coaxially.
  • the outer surface of the first slider is provided with threads
  • the first active member is a sleeve with threads provided on the inner surface
  • the first slider is placed in the sleeve and is in contact with the sleeve.
  • the sleeve is threadedly connected, and the first sliding block moves along the axial direction of the sleeve when the sleeve rotates.
  • the driving mechanism when there are two driving mechanisms and three pulling wires, the driving mechanism further includes a second driving mechanism arranged in the housing, and the pulling wires also include The second pulling wire and the third pulling wire, the proximal ends of the second pulling wire and the third pulling wire are connected to the second driving mechanism, the second pulling wire and the third pulling wire The distal end is connected to the same radial plane of the distal end of the sheath tube, and the rotating mechanism is connected with the second driving mechanism; the second driving mechanism can move relative to the housing and control the second When any one of the pulling wire and the third pulling wire is pulled, the other one is released synchronously, thereby changing the bending state of the sheath tube; the rotating mechanism simultaneously drives the sheath tube under the action of external force , the first driving mechanism and the second driving mechanism rotate coaxially relative to the housing.
  • the second drive mechanism includes a second active member, two screws that are driven with the second active member by a worm, and two second sliders respectively sleeved on the two screws,
  • the second slider is threadedly connected with the screw, and the proximal ends of the second pulling wire and the third pulling wire are respectively connected with the two second sliders;
  • the second active part is opposite to the shell
  • the two second sliders move in the opposite direction, so that when one of the second sliders pulls the traction wire connected to it, the other second slider The slider releases the pulling wire connected with it synchronously.
  • the rotating mechanism further includes a fixing frame, the two screws are passed through the fixing frame, the two inner sheath guide rods are connected to the fixing frame corresponding to the two screws, and the two screws are connected to the fixing frame.
  • the second sliders are respectively sleeved on the two inner sheath guide rods to limit the circumferential deflection of the second sliders on the corresponding screw rods; Rotate and drive the sheath to rotate coaxially through the inner sheath reinforcing tube, and drive the fixed frame to rotate through the inner sheath guide rod, and then drive the second driving part, the two screws and the corresponding The second slider rotates coaxially.
  • the second slider is threadedly connected with the screw rod and can realize self-locking.
  • a damping member is sheathed on the rotating member, and the damping member abuts against the housing to prevent the rotating member from rotating during bending adjustment.
  • a limiting groove is provided on the outer peripheral side of the inner sheath reinforcing tube, and a limiting plate is provided on the housing corresponding to the position of the limiting groove, and the limiting plate cooperates with the limiting groove to The inner sheath reinforcing tube is axially limited.
  • an adjustable curved sheath which includes a sheath, a housing arranged at the proximal end of the sheath, a first driving mechanism and a second driving mechanism arranged in the housing.
  • the proximal ends of the pulling wires are all connected to the second driving mechanism, and the distal ends of the first pulling wire, the second pulling wire and the third pulling wire are all connected to the distal end of the sheath, so The first driving mechanism and the second driving mechanism are respectively used to pull and release the traction wire connected thereto to change the bending state of the sheath tube.
  • the first driving mechanism includes a first driving ring partially exposed from the housing
  • the second driving mechanism includes a second driving ring partially exposed
  • the first driving ring is close to the The distal end of the housing
  • the second driving ring is close to the proximal end of the housing
  • the proximal end of the first pulling wire, the proximal end of the second pulling wire and the proximal end of the third pulling wire ends are located between the distal end of the first drive ring and the proximal end of the second drive ring.
  • the distal end of the first pulling wire, the distal end of the second pulling wire and the distal end of the third pulling wire are located on the same radial plane of the distal end of the sheath different positions on the same circle.
  • the adjustable curved sheath further includes a rotating mechanism connected with the sheath, the first driving mechanism and the second driving mechanism, and the rotating mechanism can simultaneously drive the sheath
  • the tube, the first drive mechanism and the second drive mechanism rotate coaxially relative to the housing.
  • the rotating mechanism includes a rotating member, a fixing frame, an inner sheath reinforcing tube and two inner sheath guide rods, and the sheath passes through the inner sheath reinforcing tube and is fixed with the inner sheath reinforcing tube connected, the inner sheath reinforcing tube and the inner sheath guide rod are both connected to the rotating member, the inner sheath reinforcing tube passes through the first driving mechanism and is connected with the second driving mechanism, and the inner sheath reinforcing tube is connected to the second driving mechanism.
  • the sheath guide rod passes through the first driving mechanism and the fixing frame, and the second driving mechanism is arranged on the fixing frame; the rotating member drives the sheath through the inner sheath reinforcing tube under the action of external force
  • the tube rotates coaxially relative to the housing, and drives the first driving mechanism and the second driving mechanism to rotate coaxially relative to the housing through the inner sheath guide rod.
  • the first driving mechanism includes a first active element and a first slider linked with the first active element, the first slider is connected to the proximal end of the first pulling wire connected, the first slider is sleeved on the inner sheath reinforcement tube; the first slider can move along the inner sheath reinforcement tube driven by the first active part, so that the first A slider pulls and releases the first pulling wire.
  • the first slider is sleeved on the two inner sheath guide rods, the rotating member rotates relative to the housing under the action of external force and drives the inner sheath reinforcing tube to drive the The sheath tube rotates coaxially, and the inner sheath guide rod drives the first sliding block and the first driving part to rotate coaxially.
  • the outer surface of the first slider is provided with threads
  • the first active member is a sleeve with threads provided on the inner surface
  • the first slider is placed in the sleeve and is in contact with the sleeve.
  • the sleeve is threadedly connected, and the first sliding block moves along the axial direction of the sleeve when the sleeve rotates.
  • the second driving mechanism includes a second active element, two second sliders that drive with the second active element, the proximal end of the second pulling wire and the third pulling wire respectively connected with the two second sliders; the two second sliders are driven by the second active part to perform reverse movement, so that one of the second sliders is connected to the pulling wire connected to it.
  • the other second slider synchronously releases the pulling wire connected thereto.
  • the two second sliders are sleeved on the two screw rods respectively, the second sliders are threadedly connected with the screw rods, and the two screw rods are passed through the fixing frame.
  • the second active part is driven by the two screws and the two second sliders, the two inner sheath guide rods are connected to the fixing frame corresponding to the two screws, and the two second sliders are sleeved on the two sides respectively.
  • the second active part moves relative to the housing under the action of external force and drives the two screw rods to rotate
  • the two second sliders move in the opposite direction
  • the rotating member rotates relative to the housing under the action of an external force and drives the sheath to rotate coaxially through the inner sheath reinforcing tube, and through the inner sheath
  • the sheath guide rod drives the fixed frame to rotate, and then drives the second driving member, the two screw rods and the corresponding second slider to rotate coaxially.
  • the second slider is threadedly connected with the screw rod and can realize self-locking.
  • the housing is provided with a perspective window.
  • a first damping member is fixed on the housing, and the first damping member abuts against the rotating member to prevent the rotating member from rotating when the bend is adjusted.
  • the inner sheath reinforcing tube passes through the second active member along the axial direction of the second active member, the inner sheath reinforcing tube is sleeved with a second damping member, the first The two damping elements abut against the second active element.
  • a limiting groove is provided on the outer peripheral side of the inner sheath reinforcing tube, and a limiting plate is provided on the housing corresponding to the position of the limiting groove, and the limiting plate cooperates with the limiting groove to The inner sheath reinforcing tube is axially limited.
  • the adjustable curved sheath provided by the present invention has the following beneficial effects:
  • the adjustable bendable sheath tube provided by the present invention comprises a sheath tube, a rotating mechanism, a housing disposed at the proximal end of the sheath tube, at least one driving mechanism disposed in the housing, and at least one traction wire, wherein the driving mechanism and the traction
  • the proximal end of the wire connection realizes the bending adjustment of the sheath tube by adjusting the driving mechanism, and at the same time connects the rotating mechanism with the sheath tube and the driving mechanism, so that the rotating mechanism rotates relative to the housing under the action of external force and simultaneously drives the sheath tube and the driving mechanism relative to each other.
  • the shell rotates coaxially.
  • one-way bending of the sheath tube is realized by connecting the first driving mechanism with the first pulling wire, and the second driving mechanism is connected with the second pulling wire and the third pulling wire to realize The two-way bending of the sheath allows the sheath to bend in three different directions.
  • one plane can be selected by adjusting the bending through any driving mechanism.
  • the sheath can be adjusted at multiple angles and directions, that is, it can achieve cross-plane bending
  • the bending direction is not limited to one plane, so as to realize the precise capture of the valve leaflet by the instrument, and meet the surgical needs of doctors and patients for the complex internal structure of the heart.
  • a single doctor can independently adjust the cross-plane bending of the sheath during the edge-to-edge repair operation, which releases the doctor's resources and improves the convenience of the operation.
  • FIG. 1 is a schematic diagram of the three-dimensional structure of the adjustable curved sheath provided in Embodiment 1 of the present invention
  • Fig. 2 is a schematic diagram of a partial exploded structure of the adjustable curved sheath provided in Embodiment 1 of the present invention
  • Fig. 3 is a schematic cross-sectional structure diagram of an adjustable curved sheath provided in Embodiment 1 of the present invention.
  • Figure 4 is an enlarged view of A in Figure 3;
  • FIG. 5 is a first schematic diagram of the internal structure of the adjustable curved sheath provided in Embodiment 1 of the present invention.
  • Figure 6 is an enlarged view of B in Figure 5;
  • Fig. 7 is a schematic diagram of the combination of the sheath and the pulling wire of the adjustable curved sheath provided in Embodiment 1 of the present invention.
  • FIG. 8 is a second schematic diagram of the internal structure of the adjustable curved sheath provided in Embodiment 1 of the present invention.
  • Fig. 9 is a schematic diagram of the internal structure of the adjustable curved sheath provided in the first embodiment of the present invention.
  • Figure 10 is an enlarged view of C in Figure 9;
  • Fig. 11 is a front view schematic diagram of the adjustable curved sheath provided in Embodiment 1 of the present invention.
  • Figure 12 is an enlarged view of D in Figure 2;
  • Fig. 13 is a schematic diagram of the internal structure of the adjustable curved sheath provided in Embodiment 2 of the present invention.
  • Figure 14 is an enlarged view of E in Figure 13;
  • Fig. 15 is a schematic diagram of the internal structure of the adjustable curved sheath provided in Embodiment 3 of the present invention.
  • Fig. 16 is a schematic diagram of the internal structure of the adjustable curved sheath provided in Embodiment 4 of the present invention.
  • Fig. 17 is a schematic diagram of the internal structure of the adjustable curved sheath provided in Embodiment 5 of the present invention.
  • Adjustable curved sheath tube 11. Housing; 12. Sheath tube; 13. Driving mechanism; 14. Pulling wire; 15. Rotating mechanism;
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be referred to as These terms are limited. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
  • proximal end the end of the medical device implanted in the human body or animal body or the delivery system that transports the medical device that is closer to the operator
  • distal end the distance from the operator The far end
  • proximal end and distal end of any part of the medical device or delivery system are defined.
  • Axial generally refers to the length direction of the medical device when it is being transported
  • radial generally refers to the direction perpendicular to the "axial” of the medical device
  • axis" of any part of the medical device is defined according to this principle to” and "radial”.
  • the embodiment of the present invention provides an adjustable curved sheath 10, the adjustable curved sheath 10 includes a housing 11, a sheath 12, at least one driving mechanism 13 and at least one pulling wire 14 , wherein, the housing 11 is arranged at the proximal end of the sheath tube 12 , and the driving mechanism 13 is arranged in the housing 11 .
  • the distal end of the pulling wire 14 is connected to the distal end of the sheath tube 12, and the proximal end of the pulling wire 14 extends into the housing 11 and is connected with the driving mechanism 13, and the driving mechanism 13 is used to pull and release the pulling wire 14 to realize the sheath tube.
  • 12 is bent, the driving mechanism 13 moves relative to the housing 11 under the action of an external force, and the moving driving mechanism 13 changes the bending state of the sheath tube 12 during the process of pulling and releasing the pulling wire 14 .
  • the housing 11 is used for convenient handling during operation.
  • the housing 11 can also provide protection and installation support functions for the driving mechanism 13 and other components.
  • the housing 11 can be formed by docking an upper shell and a lower shell.
  • a plurality of reinforcing ribs may be provided in the inner wall of the housing 11 , the setting of the reinforcing ribs can not only enhance the strength of the housing 11 , but also provide installation support for various components in the housing 11 .
  • the pulling wire 14 can be connected to the distal end of the sheath 12 through an anchoring ring (not shown), that is, the distal end of the sheath 12 is fixed with an anchoring ring, and then the distal end of the pulling wire 14 is connected to the anchoring ring.
  • the side wall of the sheath tube 12 is provided with a threading channel (not shown) through which the pulling wire 14 passes, so that a special moving channel can be provided for the pulling wire 14 to ensure its smooth movement, and at the same time, it can Provides protection from outside interference.
  • the adjustable curved sheath tube 10 also includes a hose 101 and a three-way valve 102, and the three-way valve 102 communicates with the sheath tube 12 through the hose 101, so that the three-way valve 102 can be connected to the The sheath tube 12 injects liquid or extracts body fluid.
  • the sheath tube 12 can realize unidirectional bending; when the number of pulling wires 14 is greater than 1, the sheath tube 12 can realize multi-directional bending.
  • Fig. 2- shown in Fig. 7, as a specific embodiment, two driving mechanisms 13 are provided, and three pulling wires 14 are provided, wherein, one pulling wire 14 is connected with a driving mechanism 13, and the other two pulling wires 14 are connected with Another driving mechanism 13 is connected, and the two driving mechanisms 13 move relative to the casing 11 under the action of external force and respectively pull and release the pulling wire 14 connected thereto to change the bending state of the sheath tube 12 .
  • the present invention is described by taking two driving mechanisms 13 and three pulling wires 14 as an example, which should not be construed as a limitation.
  • the driving mechanism 13 includes a first driving mechanism 131 and a second driving mechanism 132.
  • the pulling wire 14 comprises a first pulling wire 141, a second pulling wire 142 and a third pulling wire 143, the proximal end of the first pulling wire 141 is connected with the first driving mechanism 131, the second pulling wire 142 and the third pulling wire 143
  • the proximal ends are all connected to the second driving mechanism 132
  • the distal ends of the first pulling wire 141 , the second pulling wire 142 and the third pulling wire 143 are all connected to the distal end of the sheath tube 12 .
  • the first driving mechanism 131 can move relative to the casing 11 and pull and release the first pulling wire 141
  • the second driving mechanism 132 can move relative to the casing 11 and pull and release the second pulling wire 142 and the third pulling wire 143 , This allows the sheath 12 to bend in three different directions.
  • the distal end of the first pulling wire 141, the distal end of the second pulling wire 142 and the distal end of the third pulling wire 143 are located at different positions on the same circumference of the same radial plane of the distal end of the sheath tube 12, and more The closer to the distal end of the sheath 12 the better.
  • the distal end of the first traction wire 141 and the second traction wire are located at different positions on the same circumference in the same radial plane of the distal end of the sheath tube 12, which can reduce the delay of the bending of the sheath tube 12, so that the sheath tube 12 can adjust the bending time. It is more precise, so as to realize the precise capture of the valve leaflet when the instrument holding the valve leaflet is released from the adjustable curved sheath.
  • the distal end of the first pulling wire 141, the distal end of the second pulling wire 142 and the distal end of the third pulling wire 143 are located in different radial planes of the distal end of the sheath tube 12, such as the distal end of the first pulling wire 141.
  • a radial plane is located at the distal end of the sheath tube 12
  • the distal ends of the second pulling wire 142 and the third pulling wire 143 are located at another radial plane at the distal end of the sheath tube 12 .
  • the distal end of the first pulling wire 141, the distal end of the second pulling wire 142 and the distal end of the third pulling wire 143 are respectively located on different radial planes of the distal end of the sheath tube 12.
  • the embodiments of the present invention are not specifically limited.
  • the one-way bending adjustment of the sheath tube 12 is realized by connecting the first driving mechanism 131 with the first pulling wire 141, and the second driving mechanism 132 is connected with the second pulling wire 142, the first pulling wire 141
  • the three pull wires 143 are connected to realize the two-way bending adjustment of the sheath tube 12, so that the sheath tube 12 can be bent in three different directions.
  • the bending adjustment can achieve cross-plane bending, so that the direction of bending is not limited to one plane, so as to realize the precise capture of the valve leaflet by the instrument, and meet the surgical needs of doctors and patients for the complex internal structure of the heart.
  • a single doctor can independently adjust the cross-plane bending of the sheath 12 during the edge-to-edge repair operation, which releases the doctor's resources and improves the convenience of the operation sex.
  • the distal end of the pulling wire corresponding to the first driving mechanism 131 and the distal end of the pulling wire corresponding to the second driving mechanism 132 are connected to mutually perpendicular axial planes of the distal end of the sheath tube 12 .
  • the distal ends of the second pulling wire 142 and the third pulling wire 143 are connected to the same radial plane of the distal end of the sheath tube 12 and arranged symmetrically, and the second driving mechanism 132 is under the action of an external force.
  • the other one can be released synchronously, thereby changing the bending state of the sheath tube 12 .
  • the second driving mechanism 132 can pull and release the second pulling wire 142 and the third pulling wire 143, and the second driving mechanism 132 pulls any one of the second pulling wire 142 and the third pulling wire 143 At the same time, the second driving mechanism 132 is also synchronous to make the other non-tracted pulling wire follow the bending of the sheath 12 to perform corresponding bending. For example, when the second driving mechanism 132 pulls the second pulling wire 142 so that the distal end of the sheath tube 12 bends toward the side where the second pulling wire 142 is located, the third pulling wire 143 then follows the bending of the sheath tube 12.
  • the sheath tube 12 can be bent in two directions, so that bidirectional bending can be realized, thereby fully satisfying the requirements for blood vessel distortion and
  • the need for interventional treatment of complex lesion locations such as variable vascular openings greatly reduces the frequency of catheter adjustments and catheter replacements by clinical operators, making surgery easier and reducing the risk of complications.
  • the adjustable curved sheath 10 also includes a rotating mechanism 15, at least part of the rotating mechanism 15 protrudes into the casing 11 and the rotating mechanism 15 can rotate relative to the casing 11, extending into the casing
  • the rotating mechanism 15 in the body 11 is connected with the sheath tube 12, the first driving mechanism 131 and the second driving mechanism 132, so that the sheath tube 12, the first driving mechanism 131 and the second driving mechanism 132 can be simultaneously driven by the rotating mechanism 15
  • Rotate coaxially relative to the housing 11 that is, the rotating mechanism 15 rotates relative to the housing 11 under the action of an external force and at the same time drives the sheath tube 12 , the first driving mechanism 131 and the second driving mechanism 132 to rotate coaxially relative to the housing 11 .
  • the rotating mechanism 15 is connected with the sheath tube 12, the first driving mechanism 131 and the second driving mechanism 132, so that the rotating mechanism 15 rotates relative to the housing 11 under the action of an external force and simultaneously drives the sheath tube 12.
  • the first driving mechanism 131 and the second driving mechanism 132 rotate coaxially with respect to the housing 11, so that when the sheath tube 12 is rotated during the operation of complex lesions with twisted blood vessels, especially when the left atrium is opposite to the two
  • the sheath tube 12 rotates with the first driving mechanism 131 and the second driving mechanism 132 simultaneously and coaxially, it can be avoided that when the sheath tube 12 needs to be rotated, the sheath tube 12 and the first driving mechanism 131 or/and the second driving mechanism 131 or/and the second driving mechanism can be avoided.
  • the mechanism 132 does not rotate synchronously, resulting in kinking or jamming of the pulling wire 14 .
  • the rotating mechanism 15 includes a rotating member 151 , a fixing frame 152 , an inner sheath reinforcing tube 153 and two inner sheath guide rods 154 .
  • the inner sheath reinforcing tube 153 is disposed between the two inner sheath guide rods 154 .
  • the inner sheath reinforcement tube 153 and the inner sheath guide rod 154 are placed in the housing 11 .
  • the sheath tube 12 passes through the inner sheath reinforcing tube 153 and is fixedly connected with the inner sheath reinforcing tube 153 .
  • Both the inner sheath reinforcing tube 153 and the inner sheath guide rod 154 are connected with the rotating member 151 , and the inner sheath reinforcing tube 153 passes through the first driving mechanism 131 and is connected with the second driving mechanism 132 .
  • the inner sheath guide rod 154 passes through the first driving mechanism 131 and the fixed frame 152, the second driving mechanism 132 is arranged on the fixed frame 152, the rotating member 151 rotates relative to the housing 11 under the action of an external force, and at the same time, the inner sheath reinforcing tube 153 is used as a
  • the rotating shaft drives the sheath tube 12 to rotate coaxially relative to the housing 11 through the inner sheath reinforcing tube 153 , and drives the first driving mechanism 131 and the second driving mechanism 132 to rotate coaxially relative to the housing 11 through the inner sheath guide rod 154 .
  • sheath tube 12 and the inner sheath reinforcing tube 153 can be fixed with medical glue.
  • the rotating member 151 and the inner sheath reinforcing tube 153 may be connected in a clamping manner, and the rotating member 151 and the inner sheath guide rod 154 may be connected in a clamping manner.
  • the rotating member 151 may be a knob or a rotating ring, which is not specifically limited in this embodiment of the present invention.
  • the rotating member 151 can be arranged at the proximal end of the housing 11, or at the distal end of the housing 11, or it can also be arranged inside the housing 11 and exposed to the housing 11, that is, it can be arranged at the first driving position.
  • the first driving mechanism 131 and the second driving mechanism 132 keep rotating coaxially when the rotating member 151 is rotated, it is not limited in this embodiment of the present invention.
  • the sheath tube 12 is fixedly connected with the inner sheath reinforcing tube 153, the inner sheath guide rod 154 passes through the first driving mechanism 131, and the inner sheath reinforcing tube 153 and the inner sheath guide rod 154 are all connected with The rotating part 151 is connected.
  • the rotating part 151 is rotated, the inner sheath reinforcing tube 153 rotates relative to the housing 11 on its own central axis and drives the sheath tube 12 to rotate.
  • the two inner sheath guide rods 154 take the inner sheath reinforcing tube 153 as the rotation axis Rotate relative to the housing 11 and drive the first driving mechanism 131 to rotate relative to the housing 11 with the inner sheath reinforcing tube 153 as the rotation axis. Since the second driving mechanism 132 is arranged on the fixing frame 152, the inner sheath guide rod 154 passes through the fixing frame 152.
  • the inner sheath guide rod 154 drives the fixed frame 152 to rotate relative to the housing 11 with the inner sheath reinforcing tube 153 as the rotation axis, and then drives the second driving mechanism 132 to rotate relative to the housing 11 with the inner sheath reinforcing tube 153 as the rotation axis.
  • the rotating member 151 is sleeved with a first damping member 1511 , and the first damping member 1511 abuts against the casing 11 .
  • a first damping element 1511 is fixed on the housing 11 , and the first damping element 1511 abuts against the rotating element 151 .
  • the first damping member 1511 may be silica gel or rubber.
  • the first damping member 1511 includes a damping ring 15111 and a damping block 15112.
  • An annular groove 1512 is opened on the rotating member 151.
  • the damping ring 15111 is sleeved on the annular groove 1512.
  • the rotating member 151 passes through the damping block 15112.
  • the damping ring 15111 abuts
  • the damping block 15112 is connected, and the damping block 15112 and the housing 11 remain stationary.
  • the first driving mechanism 131 includes a first driving element 1311 and a first slider linked with the first driving element 1311 1312 , the first slider 1312 is connected to the proximal end of the first pulling wire 141 , and the first slider 1312 is sheathed on the inner sheath reinforcing tube 153 .
  • the first active part 1311 moves relative to the housing 11 under the action of external force and drives the first slider 1312 to move on the inner sheath reinforcing tube 153, so that the first slider 1312 pulls and releases the first pulling wire 141, and then The bending state of the sheath tube 12 is changed.
  • the first slider 1312 is sleeved on the two inner sheath guide rods 154, and the rotating member 151 rotates relative to the housing 11 under the action of an external force and at the same time drives the sheath tube 12 to rotate coaxially relative to the housing 11 through the inner sheath reinforcing tube 153 , and the inner sheath guide rod 154 drives the first sliding block 1312 and the first driving member 1311 to rotate coaxially relative to the housing 11 .
  • the first sliding block 1312 is sleeved on the two inner sheath guide rods 154, so that when the rotating member 151 rotates, the first sliding block 1312 can rotate coaxially with the rotating member 151 and drive the first driving member 1311 to rotate together. In order to avoid automatic bending of the sheath tube 12 caused by the axial displacement of the first sliding block 1312 and the first driving member 1311 when the sheath tube 12 is rotated.
  • the outer surface of the first slider 1312 is provided with threads
  • the first active member 1311 is a sleeve with threads provided on the inner surface.
  • the first slider 1312 is placed in the sleeve and is threadedly connected with the sleeve. When the barrel rotates, the first slider 1312 moves along the axial direction of the sleeve.
  • the first sliding block 1312 is threadedly connected with the sleeve and can realize self-locking, that is, the first driving mechanism 131 has self-locking ability, so as to prevent the sheath tube 12 from automatically returning to straight, and achieve the effect of stopping immediately after letting go.
  • the first driving mechanism 131 has self-locking ability, so as to prevent the sheath tube 12 from automatically returning to straight, and achieve the effect of stopping immediately after letting go.
  • a first drive ring 1313 can be sheathed on the outer peripheral side of the first active member 1311, and the first drive ring 1313 is at least partially exposed to the casing 11 and Rotate synchronously with the sleeve.
  • a limiting protruding line (not shown) may be provided on the outer peripheral side of the sleeve, and a limiting groove (not shown) may be provided on the inner peripheral side of the first drive ring 1313 corresponding to the position of the limiting protruding bar.
  • the limiting protruding strips are locked in the limiting grooves.
  • the limiting protruding line can be provided on the inner peripheral side of the first driving ring 1313, and the limiting groove can be provided on the outer peripheral side of the sleeve, as long as the first driving ring 1313 is sleeved on the first driving member 1311 When the outer peripheral side, the limiting convex strip is clamped in the limiting groove.
  • the second driving mechanism 132 includes a second active element 1321, and two second sliders 1322 which are driven by the second active element 1321 , the proximal ends of the second pulling wire 142 and the third pulling wire 143 are respectively connected to the two second sliders 1322; the second active part 1321 moves relative to the housing 11 under the action of external force and drives the two second sliders 1322 to reverse move, so that when one second slider 1322 pulls the pulling wire connected to it, the other second slider 1322 synchronously releases the pulling wire connected to it, so that the sheath tube 12 is in a radial plane change its bending state.
  • the second driving mechanism 132 also includes two screw rods 1323 corresponding to the two second sliders 1322.
  • the second active part 1321 is connected with the transmission of two second sliders 1322 through two screw rods 1323, wherein, the two screw rods 1323 are respectively arranged on the opposite sides of the second active part 1321 and are driven by gears with the second active part 1321, and the second
  • the driving part 1321 rotates
  • the two screw rods 1323 rotate in the same direction, but the thread directions on the two screw rods 1323 are opposite.
  • the second slider 1322 sleeved on the screw rod 1323 moves along the axial direction of the corresponding screw rod 1323.
  • the direction of movement of 1322 is opposite, that is to say, when the second active member 1321 moves relative to the housing 11 under the action of external force and drives the two screw rods 1323 to rotate, the two second sliders 1322 move in the opposite direction, so that a second slider When 1322 pulls the pulling wire connected thereto, another second slider 1322 releases the pulling wire connected thereto synchronously.
  • the present invention makes the structure of the whole second drive mechanism 132 more stable through the transmission mode of the second active member 1321, two screw rods 1323 and two second sliders 1322, and the transmission of force is also more balanced, so that the second pulling wire 142, the second The synchronism of the three pulling wires 143 will also be better when pulling and releasing.
  • the second driving mechanism 132 also has a larger stroke, which can make the selection range of the bending angle of the sheath tube 12 wider.
  • the two screw rods 1323 are threaded on the fixing frame 152
  • the two inner sheath guide rods 154 are connected to the fixing frame 152 corresponding to the two screw rods 1323
  • the two second sliders 1322 are respectively sleeved on the two inner sheath guide rods 154 to limit the
  • the second slider 1322 produces circumferential deflection on the corresponding screw rod 1323, so that the second slider 1322 can be limited to ensure that the second slider 1322 can only move axially on the corresponding screw rod 1323, thereby avoiding the drag wire Kinks and jams and inaccurate bending of the sheath tube 12 occur.
  • the second sliding block 1322 is threadedly connected with the screw rod 1323 and can realize self-locking, so that when the two-way bending of the adjustable bendable sheath tube 10 is performed, the second driving mechanism 132 has self-locking ability, preventing the sheath tube 12 from automatically returning Straight, to achieve the effect of letting go and stopping.
  • a second drive ring 1324 can be sheathed on the outer peripheral side of the second active member 1321, and the second drive ring 1324 is at least partially exposed to the casing 11 and is connected with The second driving element 1321 keeps rotating synchronously.
  • a limiting protrusion (not shown) may be provided on the outer peripheral side of the second active member 1321, and a limiting groove (not shown) may be provided on the inner peripheral side of the second drive ring 1324 corresponding to the position of the limiting protrusion.
  • the limiting protruding strip is clamped in the limiting groove.
  • the limiting protrusions can be provided on the inner peripheral side of the second driving ring 1324, and the limiting grooves can be provided on the outer peripheral side of the sleeve, as long as the second driving ring 1324 is sleeved on the second driving member 1321 When the outer peripheral side, the limiting convex strip is clamped in the limiting groove.
  • the inner sheath reinforcing tube 153 passes through the second active member 1321 along the axial direction of the second active member 1321, the inner sheath reinforcing tube 153 is sleeved with a second damping member 1531, and the second damping member 1531 abuts against the second active member 1321.
  • the second damping member 1531 can be silica gel or rubber.
  • the rotating member 151 drives the two screw rods 1323 and the two second sliders 1322 to rotate coaxially through the inner sheath guide rod 154 and the fixed frame 152, and then through the two screw rods 1323 and the second driving member 1321
  • the cooperation drives the second driving part 1321 to rotate synchronously, and the existence of the second damping part 1531 makes the rotating part 151 drive the second active part through the inner sheath reinforcing tube 153 when the rotating part 151 drives the sheath tube 12 to rotate.
  • the parts 1321 rotate synchronously, which improves the overall synchronization when rotating the sheath tube 12, and makes the operation more labor-saving when rotating the sheath tube 12.
  • the casing 11 is provided with a perspective window 111 at the position corresponding to the two second sliders 1322.
  • the existence of the perspective window 111 enables the doctor to perform initial calibration before performing the operation, that is, to ensure The initial state of the two second sliders 1322 is centered and aligned, so that the two-way bending adjustment of the sheath tube 12 is more accurate during the operation.
  • the sheath tube 12 since the sheath tube 12 has a delay in the process of returning to straightness, it is possible to accurately observe whether the sheath tube 12 is back in place through the perspective window 111, thereby reducing doctor's misoperation.
  • the first driving ring 1313 is close to the distal end of the housing 11
  • the second driving ring 1324 is close to the proximal end of the housing 11
  • the proximal end of the first pulling wire 141 end, the proximal end of the second pulling wire 142 and the proximal end of the third pulling wire 143 are located between the distal end of the first driving ring 1313 and the proximal end of the second driving ring 1324 .
  • the second driving mechanism 132 controls two-way bending, and its structure is more complicated.
  • the first driving mechanism 131 controls one-way bending, and its structure is relatively simple.
  • the space utilization rate of the adjustable curved sheath tube 10 tends to the middle position, and when the adjustable curved sheath tube 10 is fixed on the bracket, the imbalance at both ends of the adjustable curved sheath tube 10 is avoided.
  • a limiting groove 1532 is provided on the outer peripheral side of the inner sheath reinforcing tube 153, and a limiting plate 112 is arranged at a position corresponding to the limiting groove 1532 of the housing 11, and the limiting plate 112 and the limiting groove 1532 Cooperate to axially limit the inner sheath reinforcing tube 153 .
  • the limiting groove 1532 can be set on the inner wall of the housing 11, and the limiting plate 112 can be arranged on the outer peripheral side of the inner sheath reinforcing tube 153. This embodiment of the present invention does not make specific limitations, as long as the limiting plate 112 and the limiting plate 112 are satisfied.
  • the first driving mechanism 131 and the second driving mechanism 132 are independent of each other, so that the one-way bending adjustment and the two-way bending adjustment of the adjustable bending sheath 10 do not interfere with each other.
  • the operator rotates the first driving ring 1313 in one direction to drive the first driving member 1311 to rotate, and then drives the first slider 1312 to move on the inner sheath reinforcing tube 153, so that the first slider 1312 pulls the first pulling wire 141 to adjust the bending of the sheath tube 12.
  • the operator rotates the first driving ring 1313 in the opposite direction to drive the first driving member 1311 to reverse
  • the rotation drives the first slider 1312 to reversely move on the inner sheath reinforcing tube 153 , so that the first slider 1312 releases the first traction wire 141 and straightens the sheath tube 12 .
  • the operator rotates the second driving ring 1324 in one direction to drive the second driving member 1321 to rotate, and then drives the two screw rods 1323 to rotate, and the second slider 1322 sleeved on the screw rod 1323 moves along the corresponding screw rod.
  • the axes of 1323 move in opposite directions, so that when one second slider 1322 pulls the pulling wire connected to it, the other second sliding block 1322 synchronously releases the pulling wire connected to it, thereby The sheath tube 12 is bent toward the side where the pulling wire is pulled.
  • the operator rotates the second drive ring 1324 in the opposite direction to drive the second active member 1321 to rotate in the opposite direction, and the two screw rods 1323 Rotate, the moving directions of the two second sliders 1322 are opposite to the original ones, so that the originally pulled traction wires are released, and the originally released traction wires are pulled, so that the sheath tube 12 moves toward the position where the traction wires are pulled. Side back straight.
  • one of the first driving mechanism 131 and the second driving mechanism 132 can be used to select a suitable angle of a plane to adjust the bending, and then adjust the bending through the other, or through the first driving mechanism 132 131 and the second driving mechanism 132 adjust the bending at the same time, so that the direction of bending is not limited to one plane, which is suitable for more complex operations and meets the surgical needs of doctors and patients for complex internal structures of the heart.
  • the sheath tube 12 can be prevented from automatically rotating when the sheath tube 12 is bent, thereby affecting the doctor's operation.
  • the operator rotates the rotary member 151 to drive the inner sheath reinforcing tube 153 and the inner sheath guide rod 154 to rotate, wherein the inner sheath guide rod 154 drives the first slider 1312 to rotate, and then drives the first active Part 1311 rotates, and the inner sheath guide rod 154 drives the second slider 1322 and the screw rod 1323 to rotate, and then drives the second active part 1321 to rotate.
  • the cooperation of 1531 drives the second driving member 1321 to rotate, which improves the overall synchronization when rotating the sheath tube 12 , and makes the operation more labor-saving when rotating the sheath tube 12 .
  • the rotation and bending adjustment of the sheath tube 12 are independent of each other, that is, the rotation and bending adjustment of the sheath tube 12 are not in the same working space interface, whether the bending adjustment is performed after rotation or after the bending adjustment, it can be kept adjustable.
  • the original operation interface of the curved sheath tube 10 remains unchanged, thereby avoiding the operation risk caused by the doctor's misoperation due to the change of the operation interface.
  • the second driving mechanism 132 can also be configured in a manner of direct transmission between the second driving member 1321 and the second sliding block 1322 .
  • the second driving mechanism 132 does not include a screw rod 1323, and the two second sliders 1322 are sleeved on the two inner sheath guide rods 154 respectively, and the second slider 1322 and the second driving member 1321 are screwed, and The thread directions of the two second sliders 1322 are opposite.
  • the inner sheath guide rod 154 may be a non-circular guide rail, so as to prevent the second slider 1322 from producing circumferential deflection on the inner sheath guide rod 154 .
  • the second active member 1321 rotates, the second slider 1322 moves along the axial direction of the corresponding inner sheath guide rod 154, and the moving directions of the two second sliders 1322 are opposite, that is to say, the second active member 1321 under the action of external force Move relative to the housing 11 and drive the two second sliders 1322 to move in the opposite direction, so that when one second slider 1322 pulls the traction wire connected to it, the other second slider 1322 is connected to it synchronously The pulling wire is released.
  • the driving mechanism 13 in the third embodiment is provided with one, and the pulling wire 14 is provided with a , the proximal end of the pulling wire 14 is connected to the driving mechanism 13, and the distal end is connected to the distal end of the sheath tube 12.
  • the driving mechanism 13 can move relative to the housing 11 and pull and release the pulling wire 14 to change the bending state of the sheath tube 12. .
  • the sheath tube 12 of the embodiment of the present invention can realize one-way bending, which reduces the frequency of multiple catheter adjustments and catheter replacements by clinical operators, thereby making the operation easier to operate and reducing the risk of complications.
  • Embodiment 4 the same or similarities between Embodiment 4 and Embodiment 1 will not be repeated here.
  • the main difference between the two is that the driving mechanism 13 in Embodiment 4 is provided with one, and the pulling wire 14 is provided with two.
  • the proximal ends of the two pulling wires 14 are connected to the driving mechanism 13, and the distal ends are connected to the distal end of the sheath tube 12, and the driving mechanism 13 can move relative to the housing 11 to pull and release the two pulling wires 14 To change the bending state of the sheath tube 12.
  • the distal ends of the two pulling wires 14 are connected to the distal end of the sheath tube 12 in the same radial plane and arranged symmetrically.
  • the sheath tube 12 of the embodiment of the present invention can realize two bending adjustments in opposite directions, thereby fully satisfying the need for interventional treatment of complicated lesion positions such as blood vessel distortion and variable opening positions, and greatly reducing the need for clinical operators to perform multiple operations. Adjusting catheters and changing the frequency of catheters makes surgery easier and reduces the risk of complications.
  • Embodiment 5 the same or similarities between Embodiment 5 and Embodiment 1 will not be repeated here.
  • the main difference between the two is that there are two driving mechanisms 13 in Embodiment 5, and the pulling wire 14 is provided with Two, wherein the pulling wire 14 is connected to the driving mechanism 13 in one-to-one correspondence, and the two driving mechanisms 13 can move relative to the housing 11 and respectively pull and release the pulling wire 14 connected thereto to change the bending state of the sheath tube 12 .
  • the proximal end of a pulling wire 14 is connected to a driving mechanism 13, the distal end is connected to the distal end of the sheath 12, the proximal end of another pulling wire 14 is connected to another driving mechanism 13, and the distal end is connected to the sheath 12.
  • the distal ends of the two pull wires 14 are connected to the sheath tube 12 at different positions.
  • the distal ends of the two pull wires 14 are connected to different positions in the same radial plane of the distal end of the sheath tube 12 .
  • the sheath tube 12 of the embodiment of the present invention can realize bending adjustment in two different directions, and the two bending adjustment processes are independently controlled without affecting each other, so as to fully meet the interventional treatment for complicated lesion positions such as blood vessel distortion and variable opening positions It greatly reduces the frequency that clinical operators need to adjust catheters and replace catheters multiple times, thus making the operation easier to operate and reducing the risk of complications.

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Abstract

一种可调弯鞘管（10），涉及介入医疗器械技术领域，其包括鞘管（12）、旋转机构（15）、设于鞘管（12）近端处的壳体（11）、设于壳体（11）内的至少一驱动机构（13）、以及至少一牵引丝（14），牵引丝（14）的近端与驱动机构（13）连接、远端与鞘管（12）的远端连接，驱动机构（13）用于牵拉和释放牵引丝（14）以改变鞘管（12）的弯曲状态；旋转机构（15）可相对壳体（11）转动并且至少部分伸入壳体（11）内，伸入壳体（11）内的部分与鞘管（12）和驱动机构（13）连接，使得鞘管（12）和驱动机构（13）可在旋转机构（15）的带动下同时相对壳体（11）同轴转动。

Description

可调弯鞘管
相关申请的交叉引用
本申请要求于2021年12月31日提交中国专利局、申请号为2021116773461、发明名称为“可调弯鞘管”的中国专利申请、2021年12月31日提交中国专利局、申请号为2021234474143、发明名称为“可调弯鞘管”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及医疗器械技术领域，特别是涉及一种可调弯鞘管。
背景技术
二尖瓣疾病是老年人群中的一种常见疾病，其包括二尖瓣返流和二尖瓣狭窄两种常见类型，其中以二尖瓣返流最为常见。对于中重度或重度二尖瓣返流需要干预治疗，传统的外科治疗方式是开胸治疗，在体外循环机的支持下，打开心脏，进行瓣膜的修复或置换，但高危病人无法耐受。近年来兴起的介入治疗给二尖瓣返流的高危病人带来了希望，介入治疗一般是通过鞘管将器械输送到病变部位，进行瓣膜的修复或替换。
一般情况下，鞘管需要与配套的输送系统配合使用，手柄壳需要固定在一个支撑架上，由于心脏内部结构的多变性和复杂性，鞘管需要进行多角度多方向的调弯从而实现器械对瓣叶的精准捕获。目前市场上的鞘管对于血管扭曲的复杂病变，往往无法快捷到达预期角度和位置，需要通过体外旋转手柄器械整体，进行多次调整。然而，目前市场上的鞘管在进行调整时通常需要将手柄从支撑架上拆卸下来，然后再进行手柄器械整体的旋转，操作过程繁琐，大大延长了手术时间，增加了患者并发症发生的概率。
进一步，在左心房内对二尖瓣进行缘对缘修复手术过程中，鞘管需要进行多角度多方向的调弯从而实现器械对瓣叶的精准捕获。然而，目前的可调弯鞘管一般为单向调弯或双向调弯，其调弯方向始终处在一个平面内，无法实现跨平面调弯，相较于复杂的心脏内部结构而言，其远远无法满足医生和患者的需求，具有较大的局限性。
发明内容
基于此，本发明提供一种可调弯鞘管，以至少解决上述技术问题中的一个。
本发明为解决上述技术问题，提出一种可调弯鞘管，包括鞘管、旋转机构、设于所述鞘管近端处的壳体、设于所述壳体内的至少一驱动机构、以及至少一牵引丝，所述牵引丝的近端与所述驱动机构连接，所述牵引丝的远端与所述鞘管的远端连接，所述驱动机构用于牵拉和释放所述牵引丝以改变所述鞘管的弯曲状态；所述旋转机构的至少部分伸入所述壳体内且所述旋转机构可相对所述壳体转动，伸入所述壳体内的所述旋转机构与所述鞘管和所述驱动机构连接，使得所述鞘管和所述驱动机构可在所述旋转机构的带动下同时相对所述壳体同轴转动。
在其中一个实施例中，所述驱动机构设有两个，所述牵引丝设有两个，所述牵引丝与所述驱动机构一一对应连接，两所述驱动机构分别用于牵拉和释放与之相连的牵引丝以改变所述鞘管的弯曲状态。
在其中一个实施例中，所述驱动机构设有一个，所述牵引丝设有两个，两个所述牵引丝均与所述驱动机构连接，所述驱动机构用于牵拉和释放两所述牵引丝以改变所述鞘管的弯曲状态。
在其中一个实施例中，所述驱动机构设有两个，所述牵引丝设有三个，其中一所述牵引丝与一所述驱动机构连接，另外两个所述牵引丝与另一所述驱动机构连接，两所述驱动机构分别用于牵拉和释放与之相连的牵引丝以改变所述鞘管的弯曲状态。
在其中一个实施例中，所述旋转机构包括旋转件、内鞘加强管及两内鞘导杆，所述内鞘加强管和所述内鞘导杆置于所述壳体内，所述鞘管穿过所述内鞘加强管并与所述内鞘加强管固定连接，所述内鞘加强管和所述内鞘导杆 均与所述旋转件连接，所述内鞘导杆穿过所述驱动机构；所述旋转件在外力作用下同时通过所述内鞘加强管带动所述鞘管相对所述壳体同轴转动、以及通过所述内鞘导杆带动所述驱动机构相对所述壳体同轴转动。
在其中一个实施例中，在所述驱动机构和所述牵引丝均设有一个时，所述驱动机构包括第一驱动机构，所述牵引丝包括第一牵引丝，所述第一驱动机构包括第一主动件、及与所述第一主动件联动的第一滑块，所述第一滑块与所述第一牵引丝的近端连接，所述第一滑块套设在所述内鞘加强管上；所述第一滑块可在所述第一主动件的带动下沿所述内鞘加强管运动，以使所述第一滑块对所述第一牵引丝进行牵拉和释放。
在其中一个实施例中，所述第一滑块套设在两所述内鞘导杆上，所述旋转件在外力作用下相对所述壳体转动并通过所述内鞘加强管带动所述鞘管同轴转动、以及通过所述内鞘导杆带动所述第一滑块和第一主动件同轴转动。
在其中一个实施例中，所述第一滑块外表面设有螺纹，所述第一主动件为内表面设有螺纹的套筒，所述第一滑块置于所述套筒内并与所述套筒螺纹连接，所述套筒转动时所述第一滑块沿所述套筒的轴向运动。
在其中一个实施例中，在所述驱动机构设有两个，所述牵引丝设有三个时，所述驱动机构还包括设于所述壳体内的第二驱动机构，所述牵引丝还包括第二牵引丝和第三牵引丝，所述第二牵引丝和所述第三牵引丝的近端均与所述第二驱动机构连接，所述第二牵引丝和所述第三牵引丝的远端连接于所述鞘管的远端的同一径向平面内，所述旋转机构与所述第二驱动机构连接；所述第二驱动机构可相对所述壳体运动并对所述第二牵引丝、所述第三牵引丝中的任一个进行牵拉时，同步对另外之一进行释放，进而改变所述鞘管的弯曲状态；所述旋转机构在外力作用下同时带动所述鞘管、所述第一驱动机构和所述第二驱动机构相对所述壳体同轴转动。
在其中一个实施例中，所述第二驱动机构包括第二主动件、与所述第二主动件通过蜗杆传动的两螺杆、及分别套设于两所述螺杆上的两第二滑块，所述第二滑块与所述螺杆螺纹连接，所述第二牵引丝和所述第三牵引丝的近端分别与两所述第二滑块连接；所述第二主动件相对所述壳体运动并带动两所述螺杆转动时，两所述第二滑块做反向运动，以使一所述第二滑块对与之相连的牵引丝进行牵拉时，另一所述第二滑块同步对与之相连的牵引丝进行 释放。
在其中一个实施例中，所述旋转机构还包括固定架，两所述螺杆穿设于所述固定架上，两所述内鞘导杆对应两所述螺杆与所述固定架连接，两所述第二滑块分别套设在两所述内鞘导杆上以限制所述第二滑块在对应的所述螺杆上产生周向偏转；所述旋转件在外力作用下相对所述壳体转动并通过所述内鞘加强管带动所述鞘管同轴转动、以及通过所述内鞘导杆带动所述固定架转动，进而带动所述第二主动件、两所述螺杆和对应的所述第二滑块同轴转动。
在其中一个实施例中，所述第二滑块与所述螺杆螺纹连接且可实现自锁。
在其中一个实施例中，所述旋转件上套设有阻尼件，所述阻尼件抵接所述壳体以防止调弯时所述旋转件旋转。
在其中一个实施例中，所述内鞘加强管外周侧开设有限位槽，所述壳体对应所述限位槽的位置设置有限位板，所述限位板与所述限位槽配合以对所述内鞘加强管进行轴向限位。
本发明为解决上述技术问题，还提出一种可调弯鞘管，包括鞘管、设于所述鞘管近端处的壳体、设于所述壳体内的第一驱动机构和第二驱动机构、以及第一牵引丝、第二牵引丝和第三牵引丝，所述第一牵引丝的近端与所述第一驱动机构连接，所述第二牵引丝的近端和所述第三牵引丝的近端均与所述第二驱动机构连接，所述第一牵引丝、所述第二牵引丝和所述第三牵引丝的远端均与所述鞘管的远端相连，所述第一驱动机构和所述第二驱动机构分别用于牵拉和释放与之相连的牵引丝以改变所述鞘管的弯曲状态。
在其中一个实施例中，所述第一驱动机构包括部分露出所述壳体的第一驱动环，所述第二驱动机构包括部分露出的第二驱动环，所述第一驱动环靠近所述壳体的远端，所述第二驱动环靠近所述壳体的近端，且所述第一牵引丝的近端、所述第二牵引丝的近端及所述第三牵引丝的近端均位于所述第一驱动环的远端及所述第二驱动环的近端之间。
在其中一个实施例中，所述第一牵引丝的远端、所述第二牵引丝的远端和所述第三牵引丝的远端位于所述鞘管的远端的同一径向平面的同一圆周的不同位置。
在其中一个实施例中，所述可调弯鞘管还包括与所述鞘管、所述第一驱 动机构和所述第二驱动机构连接的旋转机构，所述旋转机构可同时带动所述鞘管、所述第一驱动机构和所述第二驱动机构相对所述壳体同轴转动。
在其中一个实施例中，所述旋转机构包括旋转件、固定架、内鞘加强管及两内鞘导杆，所述鞘管穿过所述内鞘加强管并与所述内鞘加强管固定连接，所述内鞘加强管和所述内鞘导杆均与所述旋转件连接，所述内鞘加强管穿过所述第一驱动机构并与所述第二驱动机构连接，所述内鞘导杆穿过所述第一驱动机构和所述固定架，所述第二驱动机构设于所述固定架上；所述旋转件在外力作用下通过所述内鞘加强管带动所述鞘管相对所述壳体同轴转动、以及通过所述内鞘导杆带动所述第一驱动机构和所述第二驱动机构相对所述壳体同轴转动。
在其中一个实施例中，所述第一驱动机构包括第一主动件、及与所述第一主动件联动的第一滑块，所述第一滑块与所述第一牵引丝的近端连接，所述第一滑块套设在所述内鞘加强管上；所述第一滑块可在所述第一主动件的带动下沿所述内鞘加强管运动，以使所述第一滑块对所述第一牵引丝进行牵拉和释放。
在其中一个实施例中，所述第一滑块套设在两所述内鞘导杆上，所述旋转件在外力作用下相对所述壳体转动并通过所述内鞘加强管带动所述鞘管同轴转动、以及通过所述内鞘导杆带动所述第一滑块和第一主动件同轴转动。
在其中一个实施例中，所述第一滑块外表面设有螺纹，所述第一主动件为内表面设有螺纹的套筒，所述第一滑块置于所述套筒内并与所述套筒螺纹连接，所述套筒转动时所述第一滑块沿所述套筒的轴向运动。
在其中一个实施例中，所述第二驱动机构包括第二主动件、与所述第二主动件传动的两第二滑块，所述第二牵引丝和所述第三牵引丝的近端分别与两所述第二滑块连接；两所述第二滑块在所述第二主动件的带动下做反向运动，以使一所述第二滑块对与之相连的牵引丝进行牵拉时，另一所述第二滑块同步对与之相连的牵引丝进行释放。
在其中一个实施例中，两所述第二滑块分别套设于两螺杆上，所述第二滑块与所述螺杆螺纹连接，两所述螺杆穿设于所述固定架上，所述第二主动件通过两所述螺杆与两所述第二滑块传动，两所述内鞘导杆对应两所述螺杆与所述固定架连接，两所述第二滑块分别套设在两所述内鞘导杆上以限制所 述第二滑块在对应的所述螺杆上产生周向偏转；所述第二主动件在外力作用下相对所述壳体运动并带动两所述螺杆转动时，两所述第二滑块做反向运动；所述旋转件在外力作用下相对所述壳体转动并通过所述内鞘加强管带动所述鞘管同轴转动、以及通过所述内鞘导杆带动所述固定架转动，进而带动所述第二主动件、两所述螺杆和对应的所述第二滑块同轴转动。
在其中一个实施例中，所述第二滑块与所述螺杆螺纹连接且可实现自锁。
在其中一个实施例中，所述壳体上设有透视窗。
在其中一个实施例中，所述壳体上固设有第一阻尼件，所述第一阻尼件抵接所述旋转件以防止调弯时所述旋转件旋转。
在其中一个实施例中，所述内鞘加强管沿所述第二主动件的轴向穿过所述第二主动件，所述内鞘加强管上套设有第二阻尼件，所述第二阻尼件抵接所述第二主动件。
在其中一个实施例中，所述内鞘加强管外周侧开设有限位槽，所述壳体对应所述限位槽的位置设置有限位板，所述限位板与所述限位槽配合以对所述内鞘加强管进行轴向限位。
与现有技术相比，本发明所提供的可调弯鞘管具有如下的有益效果：
本发明提供的可调弯鞘管，包括鞘管、旋转机构、设于鞘管近端处的壳体、设于壳体内的至少一驱动机构、以及至少一牵引丝，其中，驱动机构与牵引丝连接的近端，通过调节驱动机构来实现鞘管的调弯，同时将旋转机构与鞘管和驱动机构连接，使得旋转机构在外力作用下相对壳体转动并同时带动鞘管和驱动机构相对壳体同轴转动，这样一来，在血管扭曲的复杂病变的手术过程中进行鞘管的旋转时，无需将手柄从支撑架上拆卸下来，然后再进行手柄器械整体的旋转，通过调节旋转机构即可实现对鞘管的旋转，减少了手术时间，降低了患者并发症发生的概率。同时由于鞘管与驱动机构同时且同轴转动，能避免在需要鞘管转动时，但鞘管与驱动机构不同步转动而导致牵引丝的扭结或卡丝。
本发明提供的可调弯鞘管，通过将第一驱动机构与第一牵引丝连接进而实现鞘管的单向调弯，将第二驱动机构与第二牵引丝、第三牵引丝连接进而实现鞘管的双向调弯，使得鞘管可朝向三个不同的方向弯曲，在左心房内对二尖瓣进行缘对缘修复手术过程中，可以先通过任一驱动机构进行调弯选择 一平面的合适角度后，再通过另一驱动机构进行调弯，或者通过第一驱动机构和第二驱动机构同时调弯，使得鞘管能够进行多角度多方向的调弯，即能够实现跨平面调弯，使得调弯方向不局限于一个平面内，从而实现器械对瓣叶的精准捕获，满足医生和患者对复杂的心脏内部结构的手术需求。此外，通过本发明提供的可调弯鞘管，单个医生即可在缘对缘修复手术过程中单独实现对鞘管的跨平面调弯，释放了医生资源，同时提高了手术操作的便捷性。
附图说明
图1为本发明实施例一提供的可调弯鞘管的立体结构示意图；
图2为本发明实施例一提供的可调弯鞘管的部分爆炸结构示意图；
图3为本发明实施例一提供的可调弯鞘管的剖视结构示意图；
图4为图3中A的放大图；
图5为本发明实施例一提供的可调弯鞘管的内部结构示意图一；
图6为图5中B的放大图；
图7为本发明实施例一提供的可调弯鞘管的鞘管与牵引丝的组合示意图；
图8为本发明实施例一提供的可调弯鞘管的内部结构示意图二；
图9为本发明实施例一提供的可调弯鞘管的内部结构示意图三；
图10为图9中C的放大图；
图11为本发明实施例一提供的可调弯鞘管的正视结构示意图；
图12为图2中D的放大图；
图13为本发明实施例二提供的可调弯鞘管的内部结构示意图；
图14为图13中E的放大图；
图15为本发明实施例三提供的可调弯鞘管的内部结构示意图；
图16为本发明实施例四提供的可调弯鞘管的内部结构示意图；
图17为本发明实施例五提供的可调弯鞘管的内部结构示意图。
附图标识说明：
10、可调弯鞘管；11、壳体；12、鞘管；13、驱动机构；14、牵引丝；15、旋转机构；
101、软管；102、三通阀；111、透视窗；112、限位板；131、第一驱动机构；132、第二驱动机构；141、第一牵引丝；142、第二牵引丝；143、第三牵引丝；151、旋转件；152、固定架；153、内鞘加强管；154、内鞘导杆；
1311、第一主动件；1312、第一滑块；1313、第一驱动环；1321、第二主动件；1322、第二滑块；1323、螺杆；1324、第二驱动环；1511、第一阻尼件；1512、环形槽；1531、第二阻尼件；1532、限位槽；
15111、阻尼圈；15112、阻尼块。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施方式。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施方式。相反地，提供这些实施方式的目的是使对本发明的公开内容理解的更加透彻全面。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。还需要说明的是，本实施例中的左、右、上、下等方位用语，仅是互为相对概念或是以产品的正常使用状态为参考的，而不应该认为是具有限制性的。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段，但是，这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出，否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此，以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用 的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
另外，需要说明的是，在介入医疗器械领域，一般将植入人体或动物体内的医疗器械或者输送该医疗器械的输送系统的距离操作者较近的一端称为“近端”，将距离操作者较远的一端称为“远端”，并依据此原理定义医疗器械或者输送系统的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向，“径向”一般是指医疗器械的与其“轴向”垂直的方向，并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
实施例一
参阅图1和图2所示，本发明实施例提供一种可调弯鞘管10，该可调弯鞘管10包括壳体11、鞘管12、至少一驱动机构13及至少一牵引丝14，其中，壳体11设于鞘管12近端处，驱动机构13设于壳体11内。牵引丝14的远端与鞘管12的远端相连，牵引丝14的近端伸入壳体11内并与驱动机构13连接，驱动机构13用于牵拉和释放牵引丝14以实现鞘管12的弯曲，驱动机构13在外力作用下相对壳体11运动，运动的驱动机构13在牵拉和释放牵引丝14的过程中改变鞘管12的弯曲状态。
具体地，壳体11用于在操作时方便进行握持，壳体11同时可为驱动机构13等部件提供防护功能及安装支持功能，壳体11可以由上壳和下壳对接形成。进一步地，壳体11的内壁内可以设置多个加强筋(图未示)，加强筋的设置既可增强壳体11的强度，也可为壳体11内的各部件提供安装支持功能。
具体地，牵引丝14可以通过锚固环(未图示)与鞘管12的远端相连，即在鞘管12的远端固定有锚固环，再将牵引丝14的远端与锚固环相连。
具体地，鞘管12的侧壁内设置有穿设牵引丝14的穿丝通道(未图示)，从而既能为牵引丝14提供专门的移动通道，保证其顺畅移动，同时也能为其提供防护，避免受外界的干扰。
进一步地，可调弯鞘管10还包括软管101和三通阀102，三通阀102通过软管101与鞘管12连通，这样一来，可以通过注射器或者其他器械连接三 通阀102向鞘管12中注入液体或者抽取体液。
当牵引丝14的数量为1时，鞘管12可以实现单向调弯，当牵引丝14的数量大于1时，鞘管12可以实现多向调弯。
参阅图2-图7所示，作为一具体实施方式，驱动机构13设有两个，牵引丝14设有三个，其中，一牵引丝14与一驱动机构13连接，另外两个牵引丝14与另一驱动机构13连接，两驱动机构13在外力作用下相对壳体11运动并分别牵拉和释放与之相连的牵引丝14以改变鞘管12的弯曲状态。本发明以驱动机构13设有两个，牵引丝14设有三个为例进行描述，不应对此构成限定。在本发明实施例中，驱动机构13包括第一驱动机构131和第二驱动机构132，优选地，第一驱动机构131和第二驱动机构132彼此独立控制。牵引丝14包括第一牵引丝141、第二牵引丝142和第三牵引丝143，第一牵引丝141的近端与第一驱动机构131连接，第二牵引丝142和第三牵引丝143的近端均与第二驱动机构132连接，第一牵引丝141的远端、第二牵引丝142的远端和第三牵引丝143的远端均与鞘管12的远端连接。第一驱动机构131可相对壳体11运动并牵拉和释放第一牵引丝141，第二驱动机构132可相对壳体11运动并牵拉和释放第二牵引丝142和第三牵引丝143，使得鞘管12可朝向三个不同的方向弯曲。
优选地，第一牵引丝141的远端、第二牵引丝142的远端和第三牵引丝143的远端位于鞘管12的远端的同一径向平面的同一圆周的不同位置，并且更靠近鞘管12的远端端点效果越好。在采用夹持瓣叶的器械对二尖瓣或三尖瓣或者主动脉瓣进行缘对缘修复手术过程中，由于瓣叶是运动的，通过将第一牵引丝141的远端、第二牵引丝142的远端和第三牵引丝143的远端位于鞘管12的远端的同一径向平面的同一圆周的不同位置，能够降低鞘管12调弯的延迟，使得鞘管12在调弯时更加精准，从而实现夹持瓣叶的器械从该可调弯鞘管释放出来的过程中对瓣叶的精准捕获。当然，第一牵引丝141的远端、第二牵引丝142的远端和第三牵引丝143的远端位于鞘管12的远端的不同径向平面，如第一牵引丝141的远端位于鞘管12的远端的一径向平面，第二牵引丝142的远端和第三牵引丝143的远端位于鞘管12的远端的另一径向平面。或者，第一牵引丝141的远端、第二牵引丝142的远端和第三牵引丝 143的远端分别位于鞘管12的远端的不同径向平面。本发明实施例不作具体限定。
本发明提供的可调弯鞘管10，通过将第一驱动机构131与第一牵引丝141连接进而实现鞘管12的单向调弯，将第二驱动机构132与第二牵引丝142、第三牵引丝143连接进而实现鞘管12的双向调弯，使得鞘管12可朝向三个不同的方向弯曲，在左心房内对二尖瓣进行缘对缘修复手术过程中，可以先通过任一驱动机构进行调弯选择一平面的合适角度后，再通过另一驱动机构进行调弯，或者通过第一驱动机构131和第二驱动机构132同时调弯，使得鞘管12能够进行多角度多方向的调弯，即能够实现跨平面调弯，使得调弯方向不局限于一个平面内，从而实现器械对瓣叶的精准捕获，满足医生和患者对复杂的心脏内部结构的手术需求。此外，通过本发明提供的可调弯鞘管10，单个医生即可在缘对缘修复手术过程中单独实现对鞘管12的跨平面调弯，释放了医生资源，同时提高了手术操作的便捷性。
具体地，如图7所示，第一驱动机构131对应的牵引丝的远端与第二驱动机构132对应的牵引丝的远端连接于鞘管12的远端的相互垂直的轴向平面。
具体地，如图7所示，第二牵引丝142和第三牵引丝143的远端连接于鞘管12的远端的同一径向平面内且对称设置，第二驱动机构132在外力作用下相对壳体11运动并对第二牵引丝142、第三牵引丝143中的任一个进行牵拉时，可同步对另外之一进行释放，进而改变鞘管12的弯曲状态。
可以理解地，第二驱动机构132可对第二牵引丝142、第三牵引丝143进行牵拉和释放，第二驱动机构132牵拉第二牵引丝142、第三牵引丝143中的任意一个时，使得鞘管12朝向该被牵引的牵引丝的那一侧进行弯曲，与此同时，第二驱动机构132还同步使得另一个未被牵引的牵引丝随着鞘管12的弯曲而进行相应释放，例如，当第二驱动机构132牵拉第二牵引丝142使鞘管12的远端朝向第二牵引丝142所在一侧弯曲时，第三牵引丝143则随鞘管12的弯曲而进行长度的释放；当第二驱动机构132牵拉第三牵引丝143并带动鞘管12朝向第三牵引丝143所在一侧弯曲时，第二牵引丝142则随鞘管12的弯曲而进行长度的释放，这样，通过第二驱动机构132、第二牵引丝142、 第三牵引丝143的相互配合使得鞘管12可进行两个方向的弯曲，从而可实现双向弯曲，从而充分满足对于血管扭曲及血管开口位置多变等复杂病变位置进行介入治疗的需要，大大地降低了临床操作人员需要多次调整导管及更换导管的频率，从而使手术更易于操作，同时也降低了并发症产生的风险。
参阅图2和图8所示，进一步地，可调弯鞘管10还包括旋转机构15，旋转机构15的至少部分伸入壳体11内且旋转机构15可相对壳体11转动，伸入壳体11内的旋转机构15与鞘管12、第一驱动机构131和第二驱动机构132连接，使得鞘管12、第一驱动机构131和第二驱动机构132可在旋转机构15的带动下同时相对壳体11同轴转动，也即旋转机构15在外力作用下相对壳体11转动同时带动鞘管12、第一驱动机构131和第二驱动机构132相对壳体11同轴转动。
本发明提供的可调弯鞘管，将旋转机构15与鞘管12、第一驱动机构131和第二驱动机构132连接，使得旋转机构15在外力作用下相对壳体11转动并同时带动鞘管12、第一驱动机构131和第二驱动机构132相对壳体11同轴转动，这样一来，在血管扭曲的复杂病变的手术过程中进行鞘管12的旋转时，尤其是在左心房对二尖瓣进行缘对缘修复手术时，无需将手柄从支撑架上拆卸下来，然后再进行手柄器械整体的旋转，通过调节旋转机构15即可实现对鞘管12的旋转，减少了手术时间，降低了患者并发症的概率。此外，由于鞘管12与第一驱动机构131、第二驱动机构132同时且同轴转动，能避免在需要鞘管12转动时，但鞘管12与第一驱动机构131或/和第二驱动机构132不同步转动而导致牵引丝14的扭结或卡丝。
参阅图2和图8所示，作为旋转机构15的一种实施例，旋转机构15包括旋转件151、固定架152、内鞘加强管153及两内鞘导杆154。内鞘加强管153设于两内鞘导杆154之间。内鞘加强管153和内鞘导杆154置于壳体11内。鞘管12穿过内鞘加强管153并与内鞘加强管153固定连接。内鞘加强管153和内鞘导杆154均与旋转件151连接，内鞘加强管153穿过第一驱动机构131并与第二驱动机构132连接。内鞘导杆154穿过第一驱动机构131和固定架152，第二驱动机构132设于固定架152上，旋转件151在外力作用下相对壳体11转动，并同时以内鞘加强管153为旋转轴通过内鞘加强管153 带动鞘管12相对壳体11同轴转动、以及通过内鞘导杆154带动第一驱动机构131和第二驱动机构132相对壳体11同轴转动。
具体地，鞘管12与内鞘加强管153可以采用医用胶水进行固定。
具体地，旋转件151与内鞘加强管153可以采用卡接的方式进行连接，旋转件151与内鞘导杆154可以采用卡接的方式进行连接。
可选地，旋转件151可以为旋钮或旋转环，本发明实施例不作具体限定。可选地，旋转件151可以设于壳体11的近端位置，也可以设于壳体11的远端位置，还可以设置壳体11内并外露与壳体11，即设于第一驱动机构131和第二驱动机构132之间，只要满足转动旋转件151时，鞘管12、第一驱动机构131和第二驱动机构132保持同轴转动即可，本发明实施例不作具体限定。
本发明提供的可调弯鞘管10，鞘管12与内鞘加强管153固定连接，内鞘导杆154穿过第一驱动机构131，同时内鞘加强管153、内鞘导杆154均与旋转件151连接，当转动旋转件151时，内鞘加强管153以自身中轴线相对壳体11进行转动并带动鞘管12进行转动，同时两内鞘导杆154以内鞘加强管153为旋转轴相对壳体11进行转动并带动第一驱动机构131以内鞘加强管153为旋转轴相对壳体11进行转动，由于第二驱动机构132设于固定架152上，内鞘导杆154穿过固定架152，此时内鞘导杆154带动固定架152以内鞘加强管153为旋转轴相对壳体11进行转动，进而带动第二驱动机构132以内鞘加强管153为旋转轴相对壳体11进行转动，这样一来，旋转件151在外力作用下相对壳体11转动时，鞘管12、第一驱动机构131和第二驱动机构132相对壳体11保持同时且同轴转动，能避免在需要鞘管12转动时，但鞘管12与第一驱动机构131或/和第二驱动机构132不同步转动而导致牵引丝14的扭结或卡丝。
进一步地，作为一实施方式，旋转件151上套设有第一阻尼件1511，第一阻尼件1511抵接壳体11。作为另一实施方式，壳体11上固设有第一阻尼件1511，第一阻尼件1511抵接旋转件151。其中，第一阻尼件1511可以为硅胶或橡胶。在进行鞘管12的调弯时，调弯角度越大，回直力越大，所需要的操作力也越大，由于驱动机构13和旋转机构15的联动性，当回直力大到 一定程度时容易使得旋转件151产生联动，进而导致调弯时旋转件151旋转。因此，本发明通过设置第一阻尼件1511，能够防止旋转件151在调弯的时候旋转，进而影响医生的手术操作。
具体地，第一阻尼件1511包括阻尼圈15111和阻尼块15112，旋转件151上开设有环形槽1512，阻尼圈15111套设在环形槽1512上，旋转件151贯穿阻尼块15112，阻尼圈15111抵接阻尼块15112，阻尼块15112与壳体11保持静止。
继续参阅图2、图5和图6所示，作为第一驱动机构131的一种实施例，第一驱动机构131包括第一主动件1311、及与第一主动件1311联动的第一滑块1312，第一滑块1312与第一牵引丝141的近端连接，第一滑块1312套设在内鞘加强管153上。第一主动件1311在外力作用下相对壳体11运动并带动第一滑块1312在内鞘加强管153上运动，以使第一滑块1312对第一牵引丝141进行牵拉和释放，进而改变鞘管12的弯曲状态。
具体地，第一滑块1312套设在两内鞘导杆154上，旋转件151在外力作用下相对壳体11转动并同时通过内鞘加强管153带动鞘管12相对壳体11同轴转动、以及通过内鞘导杆154带动第一滑块1312和第一主动件1311相对壳体11同轴转动。通过将第一滑块1312套设在两内鞘导杆154上，使得旋转件151在转动时，第一滑块1312能够随着旋转件151同轴转动进而带动第一主动件1311一并转动，避免在旋转鞘管12时第一滑块1312和第一主动件1311产生轴向位移而导致鞘管12的自动调弯。
作为一具体实施方式，第一滑块1312外表面设有螺纹，第一主动件1311为内表面设有螺纹的套筒，第一滑块1312置于套筒内并与套筒螺纹连接，套筒转动时第一滑块1312沿套筒的轴向运动。通过将第一滑块1312设置在套筒内并与套筒螺纹连接，能够在不影响鞘管12的单向调弯的情况下，提高了壳体11内部的空间利用率。其中，第一滑块1312与套筒螺纹连接且可实现自锁，即第一驱动机构131具备自锁能力，避免鞘管12自动回直，达到松手即停的效果。此外，无需额外设置其它的锁止结构，减少二次锁止的繁琐操作，提高了手术效率，同时也降低了并发症产生的风险。
进一步地，为了方便可调弯鞘管10单向调弯的进行，可以在第一主动件 1311的外周侧套设第一驱动环1313，该第一驱动环1313至少部分外露于壳体11并与套筒保持同步转动。具体地，作为一实施方式，套筒外周侧可以设置限位凸条(未图示)，第一驱动环1313内周侧对应限位凸条的位置开设限位凹槽(未图示)，第一驱动环1313套设在第一主动件1311的外周侧时，限位凸条卡持在限位凹槽中。作为另一实施方式，限位凸条可以设置在第一驱动环1313内周侧上，限位凹槽可以开设在套筒外周侧，只要满足第一驱动环1313套设在第一主动件1311的外周侧时，限位凸条卡持在限位凹槽中即可。
参阅图2、图9和图10所示，作为第二驱动机构132的一种实施例，第二驱动机构132包括第二主动件1321、与第二主动件1321传动的两第二滑块1322，第二牵引丝142和第三牵引丝143的近端分别与两第二滑块1322连接；第二主动件1321在外力作用下相对壳体11运动并带动两第二滑块1322做反向运动，以使一第二滑块1322对与之相连的牵引丝进行牵拉时，另一第二滑块1322同步对与之相连的牵引丝进行释放，进而使得鞘管12在一径向平面内改变其的弯曲状态。
作为一具体实施方式，第二驱动机构132还包括与两第二滑块1322对应的两螺杆1323，两第二滑块1322分别套设于两螺杆1323上，第二滑块1322与螺杆1323螺纹连接，第二主动件1321通过两螺杆1323与两第二滑块1322传动连接，其中，两螺杆1323分设于第二主动件1321的相对两侧并与第二主动件1321通过齿轮传动，第二主动件1321转动时，两螺杆1323转动方向相同，而两螺杆1323上的螺纹方向相反，套设于螺杆1323上的第二滑块1322沿对应的螺杆1323的轴向运动，两第二滑块1322的运动方向相反，也就是说，第二主动件1321在外力作用下相对壳体11运动并带动两螺杆1323转动时，两第二滑块1322做反向运动，以使一第二滑块1322对与之相连的牵引丝进行牵拉时，另一第二滑块1322同步对与之相连的牵引丝进行释放。本发明通过第二主动件1321、两螺杆1323和两第二滑块1322的传动方式，使得整个第二驱动机构132结构更稳固，力的传递也更为均衡，使得第二牵引丝142、第三牵引丝143在进行牵拉和释放时同步性也将更好。同时相比较于现有的转盘式结构对牵引丝进行牵拉和释放等驱动机构，第二驱动机构132还 具有更大的行程，能够使得鞘管12的弯曲角度的选择范围更广。
具体地，两螺杆1323穿设于固定架152上，两内鞘导杆154对应两螺杆1323与固定架152连接，两第二滑块1322分别套设在两内鞘导杆154上以限制第二滑块1322在对应的螺杆1323上产生周向偏转，一来能够对第二滑块1322进行限位，保证第二滑块1322在对于的螺杆1323上只有轴向运动，从而避免了牵引丝的扭结和卡丝以及鞘管12调弯不准确等现象的发生，二来能够使得旋转件151在外力作用下相对壳体11转动时，鞘管12、第二主动件1321、两螺杆1323和对应的第二滑块1322同时相对壳体11进行整体的同轴转动。
具体地，第二滑块1322与螺杆1323螺纹连接且可实现自锁，使得在进行可调弯鞘管10的双向调弯时，第二驱动机构132具备自锁能力，避免鞘管12自动回直，达到松手即停的效果。此外，无需额外设置其它的锁止结构，减少二次锁止的繁琐操作，提高了手术效率，同时也降低了并发症产生的风险。
进一步地，为了方便可调弯鞘管10双向调弯的进行，可以在第二主动件1321的外周侧套设第二驱动环1324，该第二驱动环1324至少部分外露于壳体11并与第二主动件1321保持同步转动。具体地，作为一实施方式，第二主动件1321外周侧可以设置限位凸条(未图示)，第二驱动环1324内周侧对应限位凸条的位置开设限位凹槽(未图示)，第二驱动环1324套设在第二主动件1321的外周侧时，限位凸条卡持在限位凹槽中。作为另一实施方式，限位凸条可以设置在第二驱动环1324内周侧上，限位凹槽可以开设在套筒外周侧，只要满足第二驱动环1324套设在第二主动件1321的外周侧时，限位凸条卡持在限位凹槽中即可。
进一步地，内鞘加强管153沿第二主动件1321的轴向穿过第二主动件1321，内鞘加强管153上套设有第二阻尼件1531，第二阻尼件1531抵接第二主动件1321。其中，第二阻尼件1531可以为硅胶或橡胶。通过设置第二阻尼件1531，既能保证第二主动件1321在进行双向调弯时对两螺杆1323进行传动，又能使得第二主动件1321在不进行调弯时与内鞘加强管153保持静止，也即进一步加强了第二驱动机构132的自锁能力。此外，在转动旋转件 151时，旋转件151通过内鞘导杆154和固定架152带动两螺杆1323和两第二滑块1322整体进行同轴转动，进而通过两螺杆1323与第二主动件1321的配合带动第二主动件1321同步转动，而第二阻尼件1531的存在，使得旋转件151在通过内鞘加强管153带动鞘管12转动时，还能通过内鞘加强管153带动第二主动件1321同步转动，提高了旋转鞘管12时的整体同步性，使得在旋转鞘管12时操作更加省力。
参阅图9-图11所示，进一步地，壳体11对应两第二滑块1322的位置设有透视窗111，透视窗111的存在，使得医生在进行手术操作前能够进行初始校准，即保证两第二滑块1322的初始状态为居中对齐状态，使得手术过程中进行鞘管12的双向调弯时更加精准。同时，由于鞘管12在回直的过程中存在延迟性，通过透视窗111能够准确观察鞘管12是否回直到位，减少医生的误操作。
继续参阅图6、图10和图11所示，具体地，第一驱动环1313靠近壳体11的远端，第二驱动环1324靠近壳体11的近端，且第一牵引丝141的近端、第二牵引丝142的近端及第三牵引丝143的近端均位于第一驱动环1313的远端及第二驱动环1324的近端之间。第二驱动机构132控制双向调弯，结构较为复杂，第一驱动机构131控制单向调弯，结构较为简单，该设计能够使得可调弯鞘管10内部更加紧凑，提高可调弯鞘管10的空间利用率，使得可调弯鞘管10的重心趋于中间位置，将可调弯鞘管10固定在支架上时，避免可调弯鞘管10两端不平衡。
参阅图2和图12所示，进一步地，内鞘加强管153外周侧开设有限位槽1532，壳体11对应限位槽1532的位置设置有限位板112，限位板112与限位槽1532配合以对内鞘加强管153进行轴向限位。当然，限位槽1532可以开设在壳体11的内壁上，限位板112可以设置在内鞘加强管153的外周侧上，本发明实施例不作具体限定，只要满足限位板112与限位槽1532配合能够对内鞘加强管153进行轴向限位即可。在进行鞘管12的调弯时，调弯角度越大，回直力越大，鞘管12对内鞘加强管153有着牵扯的作用力，而内鞘加强管153贯穿可调弯鞘管10内部，鞘管12对内鞘加强管153牵扯时，容易改变可调弯鞘管10的零组件的装配间隙，间隙过大容易导致零组件之间的配合， 进而影响可调弯鞘管10的使用，间隙过小容易加大零组件之间的摩擦力，使得可调弯鞘管10的操作更加费力，本发明通过限位板112与限位槽1532配合对内鞘加强管153进行轴向限位，使得内鞘加强管153受到鞘管12的牵扯的作用力都集中在此处，进而使得可调弯鞘管10的零组件的装配间隙保持原样。
综上，本发明提供的可调弯鞘管10，第一驱动机构131和第二驱动机构132彼此独立，使得可调弯鞘管10的单向调弯和双向调弯互不干涉。在进行单向调弯时，操作者通过沿一方向转动第一驱动环1313带动第一主动件1311转动，进而带动第一滑块1312在内鞘加强管153上运动，以使第一滑块1312对第一牵引丝141进行牵拉进而对鞘管12进行调弯，当需要将鞘管12回直时，操作者通过沿相反的方向转动第一驱动环1313带动第一主动件1311反向转动，进而带动第一滑块1312在内鞘加强管153上反向运动，以使第一滑块1312对第一牵引丝141进行释放进而对鞘管12进行回直。在进行双向调弯时，操作者通过沿一方向转动第二驱动环1324带动第二主动件1321转动，进而带动两螺杆1323转动，套设于螺杆1323上的第二滑块1322沿对应的螺杆1323的轴向沿彼此相反的方向运动，以使一第二滑块1322对与之相连的牵引丝进行牵拉时，另一第二滑块1322同步对与之相连的牵引丝进行释放，从而使得鞘管12朝向牵引丝被牵拉所在一侧弯曲，当需要将鞘管12回直时，操作者通过沿相反方向转动第二驱动环1324带动第二主动件1321反向转动，两螺杆1323进行回转，两第二滑块1322的运动方向均与原来相反，进而使得原来牵拉的牵引丝进行释放，原来释放的牵引丝进行牵拉，从而使得鞘管12朝向牵引丝被牵拉所在一侧回直。当需要进行跨平面调弯时，可以先通过第一驱动机构131和第二驱动机构132之一选择一平面的合适角度进行调弯后，再通过另一进行调弯，或者通过第一驱动机构131和第二驱动机构132同时调弯，使得调弯方向不局限于一个平面内，适用于更加复杂的手术，满足医生和患者对复杂的心脏内部结构的手术需求。此外，由于设置了第一阻尼件1511，能够防止鞘管12在调弯的时候鞘管12自动旋转，进而影响医生的手术操作。
当需要对鞘管12进行旋转时，操作者转动旋转件151带动内鞘加强管 153和内鞘导杆154转动，其中，内鞘导杆154带动第一滑块1312转动，进而带动第一主动件1311转动，以及内鞘导杆154带动第二滑块1322和螺杆1323转动，进而带动第二主动件1321转动，与此同时，内鞘加强管153带动鞘管12转动以及通过第二阻尼件1531的配合带动第二主动件1321转动，提高了旋转鞘管12时的整体同步性，使得在旋转鞘管12时操作更加省力。此外，鞘管12的旋转和调弯彼此独立，即鞘管12的旋转和调弯不在同一工作空间界面，无论是在旋转之后进行调弯，还是在调弯之后进行旋转，都能够保持可调弯鞘管10原有的操作界面不变，进而避免由于操作界面变得导致医生误操作增加手术风险。
实施例二
参阅图13和图14所示，实施例二与实施例一的相同或相似之处在此不再赘述，两者的主要区别在于，实施例二的可调弯鞘管10中，作为第二驱动机构132的替代实施例，第二驱动机构132还可设置为采用第二主动件1321与第二滑块1322直接传动的方式。具体地，本实施例中第二驱动机构132不包括螺杆1323，两第二滑块1322分别套设在两内鞘导杆154上，第二滑块1322与第二主动件1321螺纹传动，且两第二滑块1322的螺纹方向相反。其中，内鞘导杆154可以为非圆形导轨，以防止第二滑块1322在内鞘导杆154上产生周向偏转。第二主动件1321转动时，第二滑块1322沿对应的内鞘导杆154的轴向运动，两第二滑块1322的运动方向相反，也就是说，第二主动件1321在外力作用下相对壳体11运动并带动两第二滑块1322做反向运动，以使一第二滑块1322对与之相连的牵引丝进行牵拉时，另一第二滑块1322同步对与之相连的牵引丝进行释放。
实施例三
参阅图15所示，实施例三与实施例一的相同或相似之处在此不再赘述，两者的主要区别在于，实施例三中的驱动机构13设有一个，牵引丝14设有一个，牵引丝14的近端与驱动机构13连接，远端均与鞘管12的远端连接，驱动机构13可相对壳体11运动并牵拉和释放牵引丝14以改变鞘管12的弯曲状态。
本发明实施例的鞘管12能够实现单向调弯，降低了临床操作人员需要多 次调整导管及更换导管的频率，从而使手术更易于操作，同时也降低了并发症产生的风险。
实施例四
参阅图16所示，实施例四与实施例一的相同或相似之处在此不再赘述，两者的主要区别在于，实施例四中的驱动机构13设有一个，牵引丝14设有两个，其中，两个牵引丝14的近端均与驱动机构13连接，远端均与鞘管12的远端连接，驱动机构13可相对壳体11运动并牵拉和释放该两牵引丝14以改变鞘管12的弯曲状态。具体地，该两个牵引丝14的远端连接于鞘管12的远端的同一径向平面内且对称设置。
本发明实施例的鞘管12能够实现两个相反方向的调弯，从而充分满足对于血管扭曲及血管开口位置多变等复杂病变位置进行介入治疗的需要，大大地降低了临床操作人员需要多次调整导管及更换导管的频率，从而使手术更易于操作，同时也降低了并发症产生的风险。
实施例五
参阅图17所示，实施例五与实施例一的相同或相似之处在此不再赘述，两者的主要区别在于，实施例五中的驱动机构13设有两个，牵引丝14设有两个，其中，牵引丝14与驱动机构13一一对应连接，两驱动机构13均可相对壳体11运动并分别牵拉和释放与之相连的牵引丝14以改变鞘管12的弯曲状态。
具体地，一牵引丝14的近端与一驱动机构13连接，远端与鞘管12的远端连接，另一牵引丝14的近端与另一驱动机构13连接，远端与鞘管12的远端连接，且该两个牵引丝14与鞘管12连接的位置不同。优选地，该两个牵引丝14的远端连接于鞘管12的远端的同一径向平面内的不同位置。
本发明实施例的鞘管12能够实现两个不同方向的调弯且该两个调弯过程独立控制，互不影响，从而充分满足对于血管扭曲及血管开口位置多变等复杂病变位置进行介入治疗的需要，大大地降低了临床操作人员需要多次调整导管及更换导管的频率，从而使手术更易于操作，同时也降低了并发症产生的风险。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未 对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (29)

  1. 一种可调弯鞘管，其特征在于：包括鞘管、旋转机构、设于所述鞘管近端处的壳体、设于所述壳体内的至少一驱动机构、以及至少一牵引丝，所述牵引丝的近端与所述驱动机构连接，所述牵引丝的远端与所述鞘管的远端连接，所述驱动机构用于牵拉和释放所述牵引丝以改变所述鞘管的弯曲状态；
    所述旋转机构的至少部分伸入所述壳体内且所述旋转机构可相对所述壳体转动，伸入所述壳体内的所述旋转机构与所述鞘管和所述驱动机构连接，使得所述鞘管和所述驱动机构可在所述旋转机构的带动下同时相对所述壳体同轴转动。
  2. 根据权利要求1所述的可调弯鞘管，其特征在于：所述驱动机构设有两个，所述牵引丝设有两个，所述牵引丝与所述驱动机构一一对应连接，两所述驱动机构分别用于牵拉和释放与之相连的牵引丝以改变所述鞘管的弯曲状态。
  3. 根据权利要求1所述的可调弯鞘管，其特征在于：所述驱动机构设有一个，所述牵引丝设有两个，两个所述牵引丝均与所述驱动机构连接，所述驱动机构用于牵拉和释放两所述牵引丝以改变所述鞘管的弯曲状态。
  4. 根据权利要求1所述的可调弯鞘管，其特征在于：所述驱动机构设有两个，所述牵引丝设有三个，其中一所述牵引丝与一所述驱动机构连接，另外两个所述牵引丝与另一所述驱动机构连接，两所述驱动机构分别用于牵拉和释放与之相连的牵引丝以改变所述鞘管的弯曲状态。
  5. 根据权利要求1-4任一项所述的可调弯鞘管，其特征在于：所述旋转机构包括旋转件、内鞘加强管及两内鞘导杆，所述内鞘加强管和所述内鞘导杆置于所述壳体内，所述鞘管穿过所述内鞘加强管并与所述内鞘加强管固定连接，所述内鞘加强管和所述内鞘导杆均与所述旋转件连接，所述内鞘导杆穿过所述驱动机构；
    所述旋转件在外力作用下同时通过所述内鞘加强管带动所述鞘管相对所述壳体同轴转动、以及通过所述内鞘导杆带动所述驱动机构相对所述壳体同 轴转动。
  6. 根据权利要求5所述的可调弯鞘管，其特征在于：在所述驱动机构和所述牵引丝均设有一个时，所述驱动机构包括第一驱动机构，所述牵引丝包括第一牵引丝，所述第一驱动机构包括第一主动件、及与所述第一主动件联动的第一滑块，所述第一滑块与所述第一牵引丝的近端连接，所述第一滑块套设在所述内鞘加强管上；所述第一滑块可在所述第一主动件的带动下沿所述内鞘加强管运动，以使所述第一滑块对所述第一牵引丝进行牵拉和释放。
  7. 根据权利要求6所述的可调弯鞘管，其特征在于：所述第一滑块套设在两所述内鞘导杆上，所述旋转件在外力作用下相对所述壳体转动并通过所述内鞘加强管带动所述鞘管同轴转动、以及通过所述内鞘导杆带动所述第一滑块和第一主动件同轴转动。
  8. 根据权利要求7所述的可调弯鞘管，其特征在于：所述第一滑块外表面设有螺纹，所述第一主动件为内表面设有螺纹的套筒，所述第一滑块置于所述套筒内并与所述套筒螺纹连接，所述套筒转动时所述第一滑块沿所述套筒的轴向运动。
  9. 根据权利要求6所述的可调弯鞘管，其特征在于：在所述驱动机构设有两个，所述牵引丝设有三个时，所述驱动机构还包括设于所述壳体内的第二驱动机构，所述牵引丝还包括第二牵引丝和第三牵引丝，所述第二牵引丝和所述第三牵引丝的近端均与所述第二驱动机构连接，所述第二牵引丝和所述第三牵引丝的远端连接于所述鞘管的远端的同一径向平面内，所述旋转机构与所述第二驱动机构连接；
    所述第二驱动机构可相对所述壳体运动并对所述第二牵引丝、所述第三牵引丝中的任一个进行牵拉时，同步对另外之一进行释放，进而改变所述鞘管的弯曲状态；所述旋转机构在外力作用下同时带动所述鞘管、所述第一驱动机构和所述第二驱动机构相对所述壳体同轴转动。
  10. 根据权利要求9所述的可调弯鞘管，其特征在于：所述第二驱动机构包括第二主动件、与所述第二主动件通过蜗杆传动的两螺杆、及分别套设于 两所述螺杆上的两第二滑块，所述第二滑块与所述螺杆螺纹连接，所述第二牵引丝和所述第三牵引丝的近端分别与两所述第二滑块连接；所述第二主动件相对所述壳体运动并带动两所述螺杆转动时，两所述第二滑块做反向运动，以使一所述第二滑块对与之相连的牵引丝进行牵拉时，另一所述第二滑块同步对与之相连的牵引丝进行释放。
  11. 根据权利要求10所述的可调弯鞘管，其特征在于：所述旋转机构还包括固定架，两所述螺杆穿设于所述固定架上，两所述内鞘导杆对应两所述螺杆与所述固定架连接，两所述第二滑块分别套设在两所述内鞘导杆上以限制所述第二滑块在对应的所述螺杆上产生周向偏转；所述旋转件在外力作用下相对所述壳体转动并通过所述内鞘加强管带动所述鞘管同轴转动、以及通过所述内鞘导杆带动所述固定架转动，进而带动所述第二主动件、两所述螺杆和对应的所述第二滑块同轴转动。
  12. 根据权利要求10所述的可调弯鞘管，其特征在于：所述第二滑块与所述螺杆螺纹连接且可实现自锁。
  13. 根据权利要求6-12任一项所述的可调弯鞘管，其特征在于：所述旋转件上套设有阻尼件，所述阻尼件抵接所述壳体以防止调弯时所述旋转件旋转。
  14. 根据权利要求6-12任一项所述的可调弯鞘管，其特征在于：所述内鞘加强管外周侧开设有限位槽，所述壳体对应所述限位槽的位置设置有限位板，所述限位板与所述限位槽配合以对所述内鞘加强管进行轴向限位。
  15. 一种可调弯鞘管，其特征在于：包括鞘管、设于所述鞘管近端处的壳体、设于所述壳体内的第一驱动机构和第二驱动机构、以及第一牵引丝、第二牵引丝和第三牵引丝，所述第一牵引丝的近端与所述第一驱动机构连接，所述第二牵引丝的近端和所述第三牵引丝的近端均与所述第二驱动机构连接，所述第一牵引丝、所述第二牵引丝和所述第三牵引丝的远端均与所述鞘管的远端相连，所述第一驱动机构和所述第二驱动机构分别用于牵拉和释放与之相连的牵引丝以改变所述鞘管的弯曲状态。
  16. 根据权利要求15所述的可调弯鞘管，其特征在于：所述可调弯鞘管 还包括与所述鞘管、所述第一驱动机构和所述第二驱动机构连接的旋转机构，所述旋转机构可同时带动所述鞘管、所述第一驱动机构和所述第二驱动机构相对所述壳体同轴转动。
  17. 根据权利要求16所述的可调弯鞘管，其特征在于：所述旋转机构包括旋转件、固定架、内鞘加强管及两内鞘导杆，所述鞘管穿过所述内鞘加强管并与所述内鞘加强管固定连接，所述内鞘加强管和所述内鞘导杆均与所述旋转件连接，所述内鞘加强管穿过所述第一驱动机构并与所述第二驱动机构连接，所述内鞘导杆穿过所述第一驱动机构和所述固定架，所述第二驱动机构设于所述固定架上；
    所述旋转件在外力作用下通过所述内鞘加强管带动所述鞘管相对所述壳体同轴转动、以及通过所述内鞘导杆带动所述第一驱动机构和所述第二驱动机构相对所述壳体同轴转动。
  18. 根据权利要求17所述的可调弯鞘管，其特征在于：所述第一驱动机构包括第一主动件、及与所述第一主动件联动的第一滑块，所述第一滑块与所述第一牵引丝的近端连接，所述第一滑块套设在所述内鞘加强管上；所述第一滑块可在所述第一主动件的带动下沿所述内鞘加强管运动，以使所述第一滑块对所述第一牵引丝进行牵拉和释放。
  19. 根据权利要求18所述的可调弯鞘管，其特征在于：所述第一滑块套设在两所述内鞘导杆上，所述旋转件在外力作用下相对所述壳体转动并通过所述内鞘加强管带动所述鞘管同轴转动、以及通过所述内鞘导杆带动所述第一滑块和第一主动件同轴转动。
  20. 根据权利要求18所述的可调弯鞘管，其特征在于：所述第一滑块外表面设有螺纹，所述第一主动件为内表面设有螺纹的套筒，所述第一滑块置于所述套筒内并与所述套筒螺纹连接，所述套筒转动时所述第一滑块沿所述套筒的轴向运动。
  21. 根据权利要求17所述的可调弯鞘管，其特征在于：所述第二驱动机构包括第二主动件、与所述第二主动件传动的两第二滑块，所述第二牵引丝 和所述第三牵引丝的近端分别与两所述第二滑块连接；两所述第二滑块在所述第二主动件的带动下做反向运动，以使一所述第二滑块对与之相连的牵引丝进行牵拉时，另一所述第二滑块同步对与之相连的牵引丝进行释放。
  22. 根据权利要求21所述的可调弯鞘管，其特征在于：两所述第二滑块分别套设于两螺杆上，所述第二滑块与所述螺杆螺纹连接，两所述螺杆穿设于所述固定架上，所述第二主动件通过两所述螺杆与两所述第二滑块传动，两所述内鞘导杆对应两所述螺杆与所述固定架连接，两所述第二滑块分别套设在两所述内鞘导杆上以限制所述第二滑块在对应的所述螺杆上产生周向偏转；
    所述第二主动件在外力作用下相对所述壳体运动并带动两所述螺杆转动时，两所述第二滑块做反向运动；所述旋转件在外力作用下相对所述壳体转动并通过所述内鞘加强管带动所述鞘管同轴转动、以及通过所述内鞘导杆带动所述固定架转动，进而带动所述第二主动件、两所述螺杆和对应的所述第二滑块同轴转动。
  23. 根据权利要求22所述的可调弯鞘管，其特征在于：所述第二滑块与所述螺杆螺纹连接且可实现自锁。
  24. 根据权利要求15所述的可调弯鞘管，其特征在于：所述壳体上设有透视窗。
  25. 根据权利要求17任一项所述的可调弯鞘管，其特征在于：所述壳体上固设有第一阻尼件，所述第一阻尼件抵接所述旋转件以防止调弯时所述旋转件旋转。
  26. 根据权利要求21所述的可调弯鞘管，其特征在于：所述内鞘加强管沿所述第二主动件的轴向穿过所述第二主动件，所述内鞘加强管上套设有第二阻尼件，所述第二阻尼件抵接所述第二主动件。
  27. 根据权利要求17任一项所述的可调弯鞘管，其特征在于：所述内鞘加强管外周侧开设有限位槽，所述壳体对应所述限位槽的位置设置有限位板，所述限位板与所述限位槽配合以对所述内鞘加强管进行轴向限位。
  28. 根据权利要求15所述的可调弯鞘管，其特征在于：所述第一驱动机构包括部分露出所述壳体的第一驱动环，所述第二驱动机构包括部分露出的第二驱动环，所述第一驱动环靠近所述壳体的远端，所述第二驱动环靠近所述壳体的近端，且所述第一牵引丝的近端、所述第二牵引丝的近端及所述第三牵引丝的近端均位于所述第一驱动环的远端及所述第二驱动环的近端之间。
  29. 根据权利要求15所述的可调弯鞘管，其特征在于：所述第一牵引丝的远端、所述第二牵引丝的远端和所述第三牵引丝的远端位于所述鞘管的远端的同一径向平面的同一圆周的不同位置。
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