WO2019037579A1 - 自膨胀假体的输送装置及自膨胀心脏瓣膜假体的输送装置 - Google Patents

自膨胀假体的输送装置及自膨胀心脏瓣膜假体的输送装置 Download PDF

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Publication number
WO2019037579A1
WO2019037579A1 PCT/CN2018/097887 CN2018097887W WO2019037579A1 WO 2019037579 A1 WO2019037579 A1 WO 2019037579A1 CN 2018097887 W CN2018097887 W CN 2018097887W WO 2019037579 A1 WO2019037579 A1 WO 2019037579A1
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WO
WIPO (PCT)
Prior art keywords
self
housing
catheter
threaded
expanding
Prior art date
Application number
PCT/CN2018/097887
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English (en)
French (fr)
Inventor
李龙飞
桂宝珠
陈国明
Original Assignee
上海微创心通医疗科技有限公司
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Priority to EP18849207.8A priority Critical patent/EP3673869A4/en
Publication of WO2019037579A1 publication Critical patent/WO2019037579A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a delivery device for a self-expanding prosthesis and a delivery device for a self-expanding heart valve prosthesis.
  • Transcatheter aortic valve implantation has the advantages of small trauma and quick recovery, and has pushed the window of survival for many patients who have been sentenced to death.
  • the research work on valvular interventional therapy in the new century has been significantly accelerated.
  • Percutaneous interventional valve implantation has progressed from experimental research to small-scale clinical parallel research. The involvement of valvular disease is expected to break through the technical bottleneck and rapidly realize a wide range of clinical applications, becoming the focus of interventional cardiology.
  • the sheath of the valve delivery device is mainly made of a polymer material and a metal material.
  • the sheath made of polymer material has good bending performance, but the tensile and compressive resistance is low, and the valve recovery cannot be achieved, and the positioning is released.
  • the sheath made of metal material is used to make the conveying device have the function of recovering the valve, and its high tensile and compressive resistance is usually obtained by using the reinforcing ribs on both sides.
  • This structural design improves the tensile and compressive capacity.
  • it greatly sacrifices the spatial bending performance of the space that is, it can only be bent in one plane direction, and the plane direction perpendicular to each other cannot be bent.
  • the aortic arch and the like have a space-shaped curved passage, so the metal sheath is It is easy to pierce the blood vessels when passing through the aortic arch, which brings great risks to clinical surgery.
  • the present invention provides a self-expanding prosthesis delivery device comprising a catheter and a handle connected to the catheter, the catheter comprising an inner catheter sequentially arranged, an inner outer catheter, an outer outer catheter and stable a state of the self-expanding prosthesis comprising a compressed state, a semi-released state, and a released state; the inner catheter for carrying a self-expanding prosthesis in a compressed state; the inner lateral catheter being rotatable relative to the inner catheter Moving and including a distal portion and a proximal portion for urging the self-expanding prosthesis from a semi-release state to a compressed state; the outer lateral catheter is moveable relative to the inner catheter, and A distal assembly and a proximal assembly for binding the self-expanding prosthesis to maintain a compressed state thereof; the bending performance of the distal assembly is stronger than the bending performance of the distal portion
  • the tensile and compressive properties of the distal portion are
  • the inner catheter comprises: a first elongated shaft, a fixed head, a second elongated shaft and a tapered head which are sequentially connected from the proximal end to the distal end.
  • the proximal end of the first elongated shaft is fixedly coupled to the handle; when the self-expanding prosthesis is delivered, the self-expanding prosthesis in a compressed state is carried on the second elongated shaft, and A proximal end of the expanded prosthesis is detachably coupled to the fixed head.
  • the fixing head comprises: a main body and at least one protruding member, each convex member being elastically connected with the main body.
  • each convex member is connected to the main body through an elastic structure, so that the convex member can perform a telescopic movement in a radial direction of the main body.
  • each convex member has a guiding surface to facilitate the smooth passage of the inner outer catheter.
  • the proximal portion of the inner outer catheter comprises a third elongated shaft
  • the distal portion comprises a metal sheath
  • the third elongated shaft The proximal end is movably coupled to the handle, and at least a portion of the metal sheath is hollowed out.
  • the hollow structure has a hollow portion, and the hollow portions are alternately arranged or threaded.
  • the proximal assembly of the outer outer catheter comprises a fourth elongated shaft, the distal assembly comprising a polymeric sheath, the fourth elongated The proximal end of the shaft is coupled to the handle and is moveable under the drive of the handle.
  • the handle comprises: a housing and a first control mechanism and a second control mechanism in the housing, the proximal end of the inner catheter, The proximal end of the stabilizing tube is fixedly coupled to the housing, the first control mechanism is for controlling movement of the inner outer tube; and the second control mechanism is for controlling movement of the outer outer tube.
  • the housing comprises: a first housing, a second housing and a third housing, wherein the first control structure is located in the first shell Between the body and the second housing, the second control structure is located between the second housing and the third housing, and the proximal end of the inner conduit is fixedly connected to the first housing The proximal end of the stabilizing tube is fixedly coupled to the third housing.
  • the first control mechanism comprises: a first threaded slider, a first threaded knob and a first locking component; the first threaded knob is limited Between the first housing and the second housing, and rotatable about an axis of the handle; the first threaded slider is configured to be fixedly coupled to the inner outer tube, and is The first threaded knob is driven to move axially along the handle; the first locking member is for controlling the rotational movement of the first threaded knob.
  • the first threaded knob has a first threaded cavity, and the first threaded slider is received in the first threaded cavity and The first threaded knob is threaded; the first threaded slider is sleeved and fixed to an outer side of the inner outer tube; the first locking member is disposed on the first threaded knob and the second shell.
  • the first locking component comprises: a first button portion, a first fastening portion, and a connection between the first button portion and the first card a first connecting portion of the buckle portion, the first button portion being disposed outside the second housing and movable in an axial direction of the second housing, the first connecting portion extending from the outside of the second housing Inside the second housing, the first latching portion is located at an end surface of the connecting portion adjacent to the first threaded knob and extends toward the first threaded knob; the first threaded knob is adjacent to the first locking component The end surface is provided with a first butt groove; the first buckle portion is matched with the first butt groove.
  • the conveying device of the self-expanding prosthesis further comprising a pair of axial guiding mechanisms axially parallel to the handle, one end of the guiding mechanism is connected to the first housing, and the other end is Extending through the first threaded slider and fixedly coupled to the second housing to limit rotational movement of the first threaded slider.
  • the second control mechanism comprises: a second threaded slider, a second threaded knob and a second locking component; the second threaded knob is limited Between the second housing and the third housing, and rotatable about an axis of the handle; the second threaded slider is configured to be fixedly coupled to the outer outer tube, and Moving axially along the handle under actuation of the second threaded knob; the second locking member is for limiting rotational movement of the second threaded knob.
  • the second threaded knob has a second threaded cavity, and the second threaded slider extends through the second threaded cavity and is An outer outer tube is connected, and the second threaded slider is externally threaded to be screwed to the second threaded knob; the second locking member is disposed on the second threaded knob and the second housing A forward and backward movement is possible between the axial direction of the handle to drive the second threaded knob to be separated or coupled to the second housing.
  • the second locking component comprises: a second button portion, a second fastening portion, and a connection between the second button portion and the second card a second connecting portion of the buckle portion, the second button portion being disposed outside the second housing and movable in an axial direction of the second housing, the second connecting portion extending from the outside of the second housing Inside the second housing, the second latching portion is located at an end surface of the second connecting portion adjacent to the second threaded knob and extends toward the second threaded knob; the second threaded knob and the second locking component Adjacent end faces are provided with a second butt groove; the second snap portion is matched with the second butt groove.
  • the inner wall of the third housing is provided with a limiting rotation groove distributed along the axial direction of the housing, and the second threaded slider
  • the outer side is provided with a limited rotation convex piece that cooperates with the groove, and the limited rotation convex piece can move back and forth along the limit rotation groove.
  • the self-expanding prosthesis is an aortic valve prosthesis, a mitral valve prosthesis or a tricuspid valve prosthesis.
  • the present invention also provides a delivery device for a self-expanding heart valve prosthesis, comprising a catheter and a handle connected to the catheter, the catheter comprising an inner catheter, an inner outer catheter, an outer outer catheter and a stabilization tube;
  • the state of the self-expanding heart valve prosthesis includes a compressed state, a semi-release state, and a released state;
  • the inner catheter is configured to carry a self-expanding heart valve prosthesis in a compressed state;
  • the inner lateral catheter can be opposite the inner catheter Moving and including a distal portion and a proximal portion for urging the self-expanding heart valve prosthesis to be compressed from a semi-release state to a compressed state;
  • the outer lateral catheter being moveable relative to the inner catheter And including a distal assembly for binding the self-expanding heart valve prosthesis to maintain its compressed state; and a proximal assembly for bending the distal portion
  • the delivery device of the self-expanding prosthesis includes a catheter and a handle connected to the catheter, and the catheter comprises an inner catheter sequentially arranged, an inner outer catheter, and an outer outer catheter.
  • the inner catheter is configured to carry a self-expanding prosthesis in a compressed state, the distal portion of the inner outer catheter is used to drive the self-expanding prosthesis from a semi-release state to a compressed state; and the distal end of the outer outer catheter is used for binding Self-expanding prosthesis to maintain its compressed state; distal component bending performance is stronger than bending performance of distal portion, tensile compression resistance of distal portion is stronger than tensile compression resistance of distal component; Staying relatively stationary with the inner catheter.
  • the self-expanding prosthesis can be released based on the outer outer catheter; the self-expanding prosthesis in a semi-release state can be recompressed and recovered based on the inner outer catheter for re-release; therefore, the same device of the present invention can simultaneously have self-expansion
  • the prosthesis recovers and releases two functions. Further, since the inner outer catheter has an outer outer tube sheath that is sleeved on the outer side thereof, the risk of puncturing the blood vessel by contact with the blood vessel when the inner outer catheter passes through the three-dimensional curved passage is avoided.
  • the inner outer tube is prepared as a metal sheath tube which is partially hollowed out, so that a certain bending property is obtained on the basis of sacrificing part of the compressive and tensile resistance, thereby ensuring that the conveying device can be safely bent through the space.
  • the passage improves the safety of the entire unit.
  • FIG. 1 is a schematic structural view of a conveying device for a self-expanding prosthesis according to an embodiment of the present invention
  • Figure 2 is a cross-sectional view showing a catheter in an embodiment of the present invention.
  • Figure 3 is a cross-sectional view showing a handle of an embodiment of the present invention.
  • FIG. 4 is a schematic structural view of an inner catheter according to an embodiment of the present invention.
  • Figure 5 is a cross-sectional view of the fixing head of Figure 4.
  • Figure 6 is a schematic structural view of an inner outer catheter in an embodiment of the present invention.
  • FIG. 7 is a schematic structural view of an outer outer tube sheathed with a stabilizer tube according to an embodiment of the present invention.
  • FIG. 8 is a schematic structural view of a first threaded slider according to an embodiment of the present invention.
  • Figure 9a is a front elevational view of the first locking member in accordance with an embodiment of the present invention.
  • Figure 9b is a front elevational view of the second locking member in accordance with an embodiment of the present invention.
  • Figure 10 is a front elevational view showing the second locking member assembled with the second housing in accordance with an embodiment of the present invention.
  • Figure 11 is a front elevational view showing the second locking member assembled between the second threaded knob and the second housing in accordance with an embodiment of the present invention
  • Figure 12 is a cross-sectional view of Figure 11 .
  • Inner catheter 10 first elongated shaft 101; fixed head 102; main body 102a; convex member 102b; guiding surface 102c; second elongated shaft 104; tapered head 103;
  • a housing 51 a housing 51; a first housing 510; a second housing 511; a third housing 512;
  • a first threaded slider 504 a first threaded knob 505; a guiding mechanism 507;
  • First locking member 506 button portions 506a, 503a; snap portions 506b, 503b; connecting portions 506c, 503c;
  • a second threaded slider 501 a second threaded knob 502; and a second locking member 503.
  • proximal and distal refers to an end near the operator, and correspondingly, “distal” or “distal” refers to an end remote from the operator.
  • distal refers to an end remote from the operator.
  • the conical head is the most distal end of the catheter and the junction of the catheter and the handle is the proximal end of the catheter.
  • the delivery device of the self-expanding prosthesis includes a catheter 1 and a handle 5 connected to the catheter 1; 2, the catheter 1 includes: an inner catheter 10, an inner outer catheter 20, an outer outer catheter 30, and a stabilization tube 40 which are sequentially sleeved; the state of the self-expanding prosthesis 3 includes a compressed state, a semi-release state, and a release state; the inner catheter 10 is for carrying a self-expanding prosthesis 3 in a compressed state; the inner outer catheter 20 is movable relative to the inner catheter 10 and includes a distal portion and a proximal portion, the distal The end portion is for driving the self-expanding prosthesis 3 from a semi-release state to a compressed state; the outer outer catheter 30 is movable relative to the inner catheter 10 and includes a distal assembly and a proximal assembly, the distal assembly
  • the self-expanding prosthesis is, for example, a self-expanding heart valve prosthesis, more specifically an aortic valve prosthesis, a mitral valve prosthesis or a tricuspid valve prosthesis.
  • the self-expanding prosthesis 3 can be released under the cooperation of the handle 5, the inner catheter 10 and the outer outer catheter 30; 5.
  • the inner catheter 10 and the inner outer catheter 20 cooperate to recompress and recover the self-expanding prosthesis in a semi-release state for re-release to meet the optimal demand for release position and reduce release. Adverse effects caused by post positional deviation.
  • the self-expanding prosthesis in a compressed state is carried on the inner catheter 10 and bound by the outer outer catheter 30; the self-expanding prosthesis in a compressed state is transported to the target Near the position, the proximal end assembly of the lateral outer catheter 30 moves relative to the proximal portion of the medial outer catheter 20 such that the self-expanding prosthesis in a compressed state is in a semi-release state; the self-expanding prosthesis is delivered Upon reaching the target position, the proximal end assembly of the lateral outer catheter 30 is withdrawn relative to the proximal portion of the medial outer catheter 20 such that the self-expanding prosthesis in a semi-release state is further released until fully released.
  • FIG. 4 is a schematic structural view of the inner catheter 10 according to an embodiment of the present invention.
  • the inner catheter 10 includes a first elongated shaft 101, a fixed head 102, a second elongated shaft 104, and a tapered head 103, which are sequentially connected, and the first elongated shaft 101 is away from one end of the fixed head 102 and
  • the handle 5 is fixedly connected, and the first elongated shaft 101 functions as a fixed support; when the self-expanding prosthesis 3 is delivered, the self-expanding prosthesis 3 in a compressed state is carried on the second elongated shaft 104.
  • the proximal end of the self-expanding prosthesis 3 is detachably connected to the fixing head 102.
  • the fixing head 102 specifically includes a main body 102a and at least one protruding member 102b.
  • the prosthetic heart valve prosthesis when the self-expanding prosthesis is a prosthetic heart valve prosthesis, the prosthetic heart valve prosthesis includes a prosthetic heart valve stent, a valve, and a skirt, wherein the prosthetic heart valve stent includes a stent body and a lug coupled to the stent body.
  • the prosthetic heart valve is detachably coupled to the fixed head 102 by attaching the lug to the raised member 102b.
  • all the protruding members 102b are elastically connected to the main body 102a.
  • each of the protruding members 102b is elastically coupled to the main body 102a by an elastic structure, so that the convex member 102b can be telescopically moved in the radial direction of the main body 102a to facilitate the outer outer tube 20 and the outer side.
  • the outer catheter 30 prevents the decoupling of the self-expanding prosthesis when moving relative to the inner catheter 10.
  • each of the convex members 102b has a guide surface 102c on the outer side of the proximal end.
  • FIG. 6 is a schematic structural view of the inner outer catheter 20 according to an embodiment of the present invention.
  • the proximal end portion of the inner outer catheter 20 includes a third elongated shaft 201
  • the distal end portion of the inner outer catheter 20 includes a metal sheath 202
  • the third elongated shaft 201 is coupled to the metal sheath 202
  • the third elongated shaft 201 is connected to the handle 5 at an end away from the metal sheath 202, and is movable under the driving of the handle 5, so that the third elongated shaft 201 can be inserted
  • the axial movement of the catheter 10 and the third elongated shaft 201 are configured to be unable to rotate in a radial direction.
  • the material of the third elongated shaft 201 is a polymer material or a metal. Since the sheath made of the metal material has high tensile and compressive resistance, the self-expanding prosthesis can be radially pressed under the action of the metal sheath 202, and therefore, the inner outer catheter 20 of the embodiment satisfies The need for recycling of self-expanding prostheses.
  • the selection of the metal material and the preparation method of the metal sheath tube 202 is not particularly limited, and any material existing in the art or any preparation method may be used.
  • the metal sheath 202 is prepared by a method of weaving or cutting using a nickel-titanium alloy.
  • the metal sheath tube 202 has a hollow structure.
  • the hollow portions in the hollow structure are alternately arranged or threaded to reduce the compressive and tensile resistance of the metal sheath tube 202, but the bending thereof Improved performance (ie, sacrificial partial compression and tensile strength, improved bendability).
  • alternating arrangement is understood to include a plurality of rows of hollow portions in the axial direction, each row of hollow portions being composed of a plurality of hollow repeating units uniformly distributed in the circumferential direction, and the hollow repeating units of the adjacent two rows of hollow portions are staggered, A row of hollows is spaced between adjacent two hollow repeating units on the same line parallel to the axial direction, wherein each of the hollow repeating units may include one or more hollowed out units.
  • thread arrangement is understood to include a plurality of rows of hollow portions in the axial direction, and each row of hollow portions is composed of at least one hollow repeating unit, and each hollow repeating unit and the adjacent row of hollow repeating units are projected from the axial direction.
  • each of the hollow repeating units may include one or more hollowed out units.
  • the metal sheath tube 202 can enter and exit the aortic arch and the like with a small radius of curvature under the protection of the outer outer catheter 30, thereby avoiding the risk of the inner outer catheter 20 piercing the blood vessel when it passes through the three-dimensional curved passage; and at the same time, the inner side is outside.
  • the metal sheath 202 of the catheter 20 acts upon the self-expanding prosthesis to meet the performance requirements for loading and recycling the self-expanding prosthesis.
  • FIG. 7 is a schematic structural view of an outer outer duct 30 that is sleeved with a stabilizer tube 40 according to an embodiment of the invention.
  • the proximal end assembly of the outer outer catheter 30 includes a fourth elongated shaft 301
  • the distal end assembly of the outer outer catheter 30 includes a polymeric sheath 302
  • the fourth elongated shaft 301 is coupled to the polymeric sheath 302
  • the fourth elongated shaft 301 is connected to the handle 5 at an end away from the polymer sheath 302, and is movable under the driving of the handle 5, so that the fourth elongated shaft 301 can be inserted
  • the axial movement of the catheter 10 and the fourth elongated shaft 301 are configured to be incapable of radial rotational movement.
  • the sheath prepared by the polymer material has good bending properties, especially spatial stereoscopic bending, and therefore, the outer outer catheter 30 of the present embodiment can satisfy the release requirement of the self-expanding prosthesis.
  • the polymer material of the polymer sheath tube 302 and the preparation method thereof are not particularly limited, and any material and any preparation method existing in the art may be employed.
  • the polymer sheath 302 is prepared by extrusion molding using PEBA, PA, PU, TPE materials.
  • the stabilizing tube 40 acts similarly to the stabilizing tube of the prior art, for example, it can prevent the outer tube from being directly exposed to the blood vessel and damaging the blood vessel when the outer tube moves. Therefore, the stabilizer tube in this embodiment can employ any of the existing stabilizer tubes.
  • FIG. 3 is a cross-sectional view of a handle according to an embodiment of the invention.
  • the handle 5 includes a housing 51 and a first control mechanism and a second control mechanism in the housing 51, the proximal end of the inner catheter 10, the proximal end of the stabilization tube 40 and the shell respectively.
  • the body 51 is fixedly connected, the first control mechanism is for controlling the movement of the inner outer duct 20; the second control mechanism is for controlling the movement of the outer outer duct 30, based on the first control mechanism and the second control
  • the cooperation of the mechanism can realize the semi-release state of the self-expanding prosthesis to the compressed state, or from the compressed state to the semi-release state or the release state, which simplifies the operation process.
  • the specific control principle should be understood in conjunction with the subsequent specific structure of the first control mechanism and the second control mechanism.
  • the housing 51 includes a first housing 510, a second housing 511, and a third housing 512, the first control structure being located at the first housing 510 and the second housing Between the bodies 511, the second control structure is located between the second housing 511 and the third housing 512, and the proximal end of the inner conduit 10 is fixedly connected to the first housing 510. The proximal end of the stabilizing tube 40 is fixedly coupled to the third housing 512.
  • the first control mechanism includes a first threaded slider 504, a first threaded knob 505 and a first locking member 506; the first threaded knob 505 is constrained to the first housing 510 and the second Between the housings 511, and can rotate about the axis of the handle (ie, the first threaded knob 505 is configured to be rotatable in the circumferential direction of the handle 5, but cannot move axially);
  • a threaded slider 504 is configured to be fixedly coupled to the inner outer catheter 20 and is moved in the axial direction of the handle 5 by the first threaded knob 505; the first locking member 506 is for The rotational movement of the first threaded knob 505 is limited (ie, the first locking member 506 can determine whether the first threaded knob 505 can perform a rotational motion).
  • first threaded knob 505 has a first threaded cavity (the internal thread of the first threaded cavity has an internal thread), and the first threaded slider 504 is received in the first threaded cavity And threadedly coupled to the first threaded knob 505 (ie, the first threaded slider 504 has an external thread that matches an internal thread on a body wall of the first threaded cavity), the first thread
  • the slider 504 is sleeved and fixed to the outer side of the inner outer tube 20 (specifically, the first threaded slider 504 is sleeved and fixed to the end of the third elongated shaft 201 away from the metal sheath tube 202);
  • the first locking member 506 is disposed between the first threaded knob 505 and the second housing 511 and can move back and forth along the axial direction of the handle 5 to drive the first threaded knob 505 and the The second housing 511 is separated or coupled; wherein, when the first threaded knob 505 is separated from the second housing 511
  • the conveying device is further provided with a pair of guiding mechanisms axially parallel to the axial direction of the handle 5. 507, one end of the guiding mechanism 507 is connected to the first housing 510, and the other end extends through the first threaded slider 504 and is fixedly connected with the second housing 511 to limit the first The rotational movement of the threaded slider 504.
  • the first threaded slider 504 is provided with a first through hole, a second through hole and a third through hole in the axial direction thereof, the first through hole is a center hole, and the inner outer tube 20 is worn.
  • the inner tube 10 passes through the inner outer tube 20 and is fixed to the first housing 510, and the two guiding mechanisms 507 respectively penetrate the second
  • the through hole and the third through hole are fixed to the first housing 510 and the second housing 511, and the first threaded slider 504 can only move along the two guiding mechanisms 507, thereby limiting the occurrence of the first threaded slider 504. Rotate.
  • first threaded slider 504 and the first threaded knob 505 are screw-fitted to each other, and the first threaded slider 504 is sleeved and fixed to the outer side of the inner outer tube 20, the first thread is rotated clockwise or counterclockwise.
  • the knob 505 When the knob 505 is used, the first threaded slider 504 is moved forward or backward (moving in the axial direction of the handle 5 to convert the rotational motion into a horizontal movement), thereby driving the inner outer catheter 20 to advance or retreat.
  • the second control mechanism includes: a second threaded slider 501, a second threaded knob 502, and a second locking member 503; the second threaded knob 502 is constrained to the second housing 511 and the third Between the housings 512, and the second threaded knob 502 is configured to be rotatable in the circumferential direction of the handle 5 (ie, about the axis of the handle), but not axially.
  • the second threaded slider 501 is configured to be fixedly coupled to the outer outer tube 30 and moved in the axial direction of the handle 5 under the driving of the second threaded knob 502; the second locking member 503 is for limiting the rotational movement of the second threaded knob 502.
  • the second threaded knob 502 has a second threaded cavity, the second threaded cavity has an internal thread on the inner wall, and the second threaded slider 501 extends through the second threaded cavity and the outer side
  • the outer catheter 30 is coupled, and the second threaded slider 501 is externally threaded for screwing with the second threaded knob 502.
  • the outer wall of the second threaded slider 501 has an external thread matching the internal thread on the inner wall of the second threaded cavity, and the second threaded slider 501 is sleeved and fixed to the The outer side of the proximal end of the fourth elongated shaft 301 of the outer outer tube 30 forms a fitting tube.
  • the assembly tube extends through the body cavity of the third housing 512 and is then received in the stabilization tube and extends to the distal end.
  • the second locking member 503 is disposed between the second threaded knob 502 and the second housing 511 and can move back and forth along the axial direction of the handle 5 to drive the second threaded knob 502 and The second housing 511 is separated or combined.
  • the second threaded knob 502 When the second threaded knob 502 is separated from the second housing 511, the second threaded knob 502 can rotate about the axis of the handle 5; the second threaded knob 502 and the second housing 511 When combined, the second threaded knob 502 and the second housing 511 are equivalent to one piece (at this time, the second locking member 503 is used to fix the position of the second threaded knob 502, thereby braking the second Threaded slider 501), there is no relative motion between the two.
  • the inner wall of the third housing 512 is provided with a limiting rotation groove (not shown) distributed along the axial direction of the housing, and the outer side of the second threaded slider 501 is provided with
  • the limiting rotating sleeve is matched with the limited rotating convex member, and the limited rotating convex member is movable forward and backward along the limiting rotating groove.
  • the limit rotation groove functions to restrict the guide so that the second threaded slider 501 can only rotate in the axial direction of the handle 5 and cannot rotate circumferentially around the axis of the handle 5.
  • the second threaded slider 501 and the second threaded knob 502 are in mesh with each other, and one end of the second threaded slider 501 is fixedly connected to the outer outer tube 30, the second threaded knob is rotated clockwise or counterclockwise.
  • the second threaded slider 501 is moved forward or backward (moving in the axial direction of the handle 5 to convert the rotational motion into a horizontal movement), thereby driving the outer outer duct 30 to advance or retreat.
  • FIG. 9a is a front view of the first locking member in the embodiment
  • FIG. 9b is a front view of the second locking member in the embodiment.
  • the first locking member 506 includes a first button portion 506a, a first snap portion 506b, and a first connecting portion 506c that connects the first button portion 506a and the first snap portion 506b.
  • the first button portion 506a is disposed outside the proximal end of the second housing 511 and is movable along the axial direction of the second housing 511, and the first connecting portion 506c is The second housing 511 extends outside into the second housing 511, and the first fastening portion 506a is located at an end surface of the first connecting portion 506c adjacent to the first threaded knob 505 and extends toward the first threaded knob 505 (in other words, The first snap portion 506a faces the end surface of the first threaded knob 505).
  • the first button portion 506a is movable in the axial direction of the second housing 511 to drive the first snap portion 506b apart or combined with the adjacent first docking groove.
  • the first fastening portion 506b is further provided with a first stabilizing portion on both sides thereof, and the stabilizing portion is arcuate to cooperate with the inner wall of the proximal end of the second housing 511 to increase the axial direction of the first locking member. The stability of the movement.
  • the second locking member 503 is similar to the first locking member 506, and includes a second button portion 503a, a second fastening portion 503b, and a second button portion 503a and a second buckle portion 503b.
  • the second connecting portion 503c is that the second button portion 503a is disposed outside the distal end of the second housing 511 and is movable along the axial direction of the second housing 511, and the second connecting portion 503c is from the second housing 511.
  • the second latching portion 503a is located at the end of the connecting portion 503c adjacent to the second threaded knob 502 and extends toward the second threaded knob 502 (ie, the second latching portion) 503a faces the end face of the second threaded knob 502).
  • the first threaded knob 505 is provided with a plurality of first butting grooves in the circumferential direction of the end surface adjacent to the first locking member 506; the second threaded knob 502 and the second thread A plurality of second butting recesses are disposed in the circumferential direction of the adjacent end faces of the locking members 503, and the first latching portions 506a and the second latching portions 503a are respectively matched with the mating recesses on the adjacent end faces thereof.
  • FIG. 10 is a front view of the second locking member 503 when assembled with the second housing 511 .
  • the buckle portion 503a faces away from the end surface of the second housing 511.
  • FIG. 11 is a perspective view of the second locking member 503 assembled between the second threaded knob and the second housing;
  • FIG. 12 is a cross-sectional view of FIG.
  • the second button portion 503a is disposed outside the distal end of the second housing 511 and is movable in the axial direction of the second housing 511.
  • the second connecting portion 503c extends from the outside of the second housing 511 through a recess in the second housing 511 to the inner side of the second housing 511, the second fastening portion
  • a second stabilizing portion is further disposed on both sides of the 506b, and the stabilizing portion is arcuate to cooperate with the inner wall of the distal end of the second housing 511.
  • the second fastening portion 503a is located at an end surface of the second connecting portion 503c facing away from the second housing 511 and extends toward the second threaded knob 502.
  • the second fastening portion 503a is engaged with the second butting groove provided on the end surface of the second threaded knob 502.
  • the aortic valve prosthesis is taken as an example, and the loading of the aortic valve prosthesis is described in detail in conjunction with FIGS. 2, 4, 6, and 7. , release and recovery and release process.
  • the “compressed state” herein refers to a state in which the self-expanding prosthesis is radially compressed by means of a radial external force or the like in order to smoothly pass the self-expanding prosthesis through the tubular organ of the human body (for example, a blood vessel);
  • Release state refers to a state in which the self-expanding prosthesis reaches the target position and is unfolded at the target position after the external restraint is removed;
  • the "semi-release state” refers to a state in which a portion of the self-expanding prosthesis is no longer subjected to radial restraint and the other portion is still restrained and compressed.
  • the loading process of the aortic valve prosthesis, the valve prosthesis that is about to release the state of the valve prosthesis is a compressed valve prosthesis:
  • the loading of the aortic valve prosthesis is carried out in an in vitro ice water bath with the aid of a loading tool or the like. Therefore, the aortic valve prosthesis in a compressed state can be well gripped on the second elongated shaft 104 between the fixed head 102 and the tapered head 103 by using the polymer sheath 302 in the outer outer catheter 30, At this time, the metal sheath tube 202 is placed on the back side of the fixed head 102 (the metal sheath tube 202 does not cover the artificial heart valve).
  • the mounting ear of the aortic valve prosthesis is fixed to the convex part 102b of the fixing head 102 by means of a loading tool, and the second threaded knob 502 is rotated forward (clockwise or counterclockwise) to make the polymer sheath 302 in the second thread.
  • the rotation of the knob 502 is advanced until the polymer sheath 302 completely covers the compressed aortic valve prosthesis and is fitted to the conical head 103, and the loading of the aortic valve prosthesis is completed.
  • Aortic valve prosthesis release and recovery and re-release process that is, the compression of the valve prosthesis into a semi-release state / release state of the valve prosthesis:
  • the core idea of the present invention is that in the area of the large bypass path such as the aortic arch, in order to ensure that the sheath of the self-expanding prosthesis in the compressed state can smoothly pass the bow, the sheath usually sacrifices the compressive and tensile resistance in order to obtain good bending performance.
  • the self-expanding prosthesis becomes a semi-release state after releasing a part of the body in the body, and needs to be re-harvested into a compressed state due to various reasons such as poor release position.
  • the outer tube, especially the sheath portion requires a large pressure resistance. It is difficult to balance the bending properties of the pipe with the tensile and compressive requirements of the material or structure. Therefore, it is necessary to use different performance methods at different times or spaces to solve this contradiction.
  • the compressed aortic valve prosthesis is bound by the polymeric sheath 302 on the outer outer catheter 30.
  • the metal sheath tube 202 is located on the rear side of the fixed head 102, and the polymer sheath tube 302 has good bending performance and can be spatially curved, thereby ensuring that the conveying device is safely arched.
  • the second threaded knob 502 is reversely rotated (compared to the direction of rotation of the prosthetic heart valve), and the polymeric sheath 302 is withdrawn to release the aortic valve prosthesis.
  • the aortic valve prosthesis is gradually released from the inflow tract portion, and the aortic valve prosthesis changes from a compressed state to a semi-release state, that is, a portion of the aortic valve prosthesis (eg, the outflow tract portion) is no longer bound and begins to expand, and another A portion (e.g., the inflow channel portion) is still bound by the polymeric sheath 302 to be compressed.
  • the aortic valve prosthesis When the aortic valve prosthesis is released, if the surgical practitioner finds that the aortic valve prosthesis is not released, the aortic valve prosthesis needs to be retracted to reposition the release position. Retrieving the aortic valve prosthesis requires re-clamping the aortic valve prosthesis from a semi-release state to a compressed state. This requires overcoming a large amount of resistance, so it is necessary to recover the press grip using a metal sheath 202 having a greater compression and tensile resistance. The specific process is as follows:
  • the second locking member 503 is pushed to brake the polymer sheath 302 in the outer outer tube 30, and the first threaded knob 505 is rotated forward to cause the metal sheath 202 to be rotated by the rotation of the first threaded knob 505.
  • the distal end advances until the metal sheath 202 grips the aortic valve prosthesis and re-clamps the aortic valve prosthesis from a semi-release state into a compressed state.
  • the metal sheath tube 202 has poor bending performance, it has a protection of the outer outer tube 30 on the outer side, avoiding the risk of puncturing the blood vessel by contact with the blood vessel when the three-dimensional curved path is passed; and at the same time, due to the convex part 102b of the fixing head 102 and fixing
  • the main body 102a of the head 102 is elastically coupled, so that the convex member 102b can be telescopically moved in the radial direction of the main body 102a, and the metal sheath tube 202 can be surely passed through the fixing head 102 and the polymer sheath tube 302.
  • the first locking member 506 is pushed to brake the metal sheath 202, and the second locking member 503 is released from braking the polymer sheath 302.
  • the second threaded knob 502 is rotated forward to push the polymer sheath 302 forward to the distal end to completely cover the aortic valve prosthesis.
  • the second locking member 503 is pushed to brake the polymer sheath 302, the first locking member 506 is released from braking the metal sheath 202, the first threaded knob 505 is reversely rotated, and the metal sheath 202 is withdrawn proximally. .
  • the metal sheath 202 passes through the fixing head 102, since the convex member 102b of the fixing head 102 is elastically coupled to the main body 102a of the fixing head 102, the convex member 102b can be telescopically moved in the radial direction of the main body 102a.
  • the metal sheath 202 can be ensured to pass without the aortic valve prosthesis decoupling.
  • the first locking member 506 is pushed to brake the metal sheath 202.
  • the second locking member 503 is released from braking the polymer sheath 302, and the aortic valve prosthesis can be repositioned again.
  • the delivery device of the self-expanding prosthesis comprises a catheter and a handle connected to the catheter, and the catheter comprises an inner catheter sequentially arranged, an inner outer catheter, and an outer side.
  • An outer catheter and a stabilizing tube the inner catheter is configured to carry a self-expanding prosthesis in a compressed state, the distal portion of the inner outer catheter is used to drive the self-expanding prosthesis from a semi-release state to a compressed state; and the distal assembly of the outer outer catheter It is used to restrain the self-expanding prosthesis to maintain its compression state; the bending performance of the distal component is stronger than the bending performance of the distal part, and the tensile and compressive properties of the distal part are stronger than the tensile and compressive properties of the distal component.
  • the stabilizing tube remains relatively stationary with the inner conduit.
  • the self-expanding prosthesis can be released based on the outer outer catheter; the self-expanding prosthesis in a semi-release state can be recompressed and recovered based on the inner outer catheter for re-release; therefore, the same device of the present invention can simultaneously have self-expansion
  • the prosthesis recovers and releases two functions.
  • the inner outer catheter has an outer outer tube sheath that is sleeved on the outer side thereof, the risk of puncturing the blood vessel by contact with the blood vessel when the inner outer catheter passes through the three-dimensional curved passage is avoided.
  • the inner outer tube is prepared as a metal sheath tube which is partially hollowed out, so that a certain bending property is obtained on the basis of sacrificing part of the compressive and tensile resistance, thereby ensuring that the conveying device can be safely bent through the space.
  • the passage improves the safety of the entire unit.
  • the outer outer tube is made of a pure polymer material
  • the inner outer tube is made of a pure metal material
  • suitable materials such as composite preparation, in particular, by braided ribs or spiral ribs.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

一种自膨胀假体(3)的输送装置，包括导管(1)和手柄(5)，导管(1)包括依次套接的内导管(10)、内侧外导管(20)、外侧外导管(30)及稳定管(40)；内导管(10)用于承载处于压缩状态的自膨胀假体(3)；内侧外导管(20)可相对于内导管(10)移动，包括远端部分和近端部分，远端部分用于驱使自膨胀假体(3)从半释放状态压缩至压缩状态；外侧外导管(30)可相对于内导管(10)移动，包括远端组件和近端组件，远端组件用于束缚自膨胀假体(3)；远端组件弯曲性能强于远端部分的弯曲性能，远端部分的抗拉、抗压性能强于远端组件的抗拉、抗压性能；稳定管(40)与内导管(10)保持相对静止。基于外侧外导管(30)能够进行自膨胀假体(3)释放；基于内侧外导管(20)能够将处于半释放状态的自膨胀假体(3)再次压缩回收，以便进行重新释放；因此，输送装置能够兼具自膨胀假体(3)回收和释放两个功能。

Description

自膨胀假体的输送装置及自膨胀心脏瓣膜假体的输送装置 技术领域
本发明涉及医疗器械技术领域，特别涉及一种自膨胀假体的输送装置及自膨胀心脏瓣膜假体的输送装置。
背景技术
经导管主动脉瓣膜植入术具有创伤小、恢复快等优点，为许多被判死刑的患者推开了继续生存的窗口。新世纪瓣膜病介入治疗的研究工作明显加速，经皮介入瓣膜植入术已经由实验研究发展到了小规模临床并行的研究阶段。瓣膜病介入有望突破技术上的瓶颈，迅速实现广泛的临床应用，成为介入心脏病学领域的关注焦点。
然而现有的介入心脏瓣膜置换术在实际临床中，还存在诸多问题。例如人工心脏瓣膜在病变位置没有完全释放时，手术实施者发现瓣膜释放位置不够理想，需要回收瓣膜重新定位释放。瓣膜在体内回收时，没有装载工具等辅助器具的协助，管材尤其是压握瓣膜的鞘管部分需要克服很大的阻力，这就要求鞘管部分具有极高的抗拉、抗压能力，同时压握瓣膜的鞘管部分需要通过主动脉弓等这样的大迂回通路，这就要求鞘管部分需具有良好的弯曲性能。如何平衡鞘管的这两个对立的性能，成为业内难题。
目前临床使用或可见的报道中，瓣膜输送装置压握瓣膜的鞘管主要由高分子材料和金属材料制成。高分子材料制成的鞘管具有良好的弯曲性能，但是抗拉抗压能力低，无法做到瓣膜回收，重新定位释放。金属材料制成的鞘管是为了使输送装置具有回收瓣膜的功能，其高的抗拉抗压能力通常是利用其两侧的加强筋获得的，这样的结构设计虽然提高了抗拉抗压能力，但是却极大的牺牲掉了空间立体弯曲性能，即只能在一个平面方向弯曲，相互垂直的平面方向不能弯曲，然而主动脉弓等是具有空间立体弯曲的通路，因此这种金属材质鞘管在过主动脉弓时极易刺穿血管，给临床手术带来极大的风险。
针对现有的瓣膜输送装置的不足，本领域技术人员一直在寻找解决的方法。
发明内容
本发明的目的在于提供一种自膨胀假体的输送装置，以解决现有的瓣膜输送装置无法兼顾瓣膜回收和瓣膜植入的问题。
为解决上述技术问题，本发明提供一种自膨胀假体的输送装置，包括导管和与所述导管连接的手柄，所述导管包括依次套接的内导管、内侧外导管、外侧外导管及稳定管；所述自膨胀假体的状态包括压缩状态、半释放状态和释放状态；所述内导管，用于承载处于压缩状态的自膨胀假体；所述内侧外导管可以相对于所述内导管移动，且包括远端部分和近端部分，所述远端部分用于驱使所述自膨胀假体从半释放状态压缩至压缩状态；所述外侧外导管可以相对于所述内导管移动，且包括远端组件和近端组件，所述远端组件用于束缚所述自膨胀假体，以维持其压缩状态；所述远端组件的弯曲性能强于所述远端部分的弯曲性能，所述远端部分的抗拉、抗压性能强于所述远端组件的抗拉、抗压性能；所述稳定管与所述内导管保持相对静止。
可选的，在所述的自膨胀假体的输送装置中，所述内导管包括：从近端至远端依次连接的第一细长轴、固定头、第二细长轴和锥形头，所述第一细长轴的近端与所述手柄固定连接；输送所述自膨胀假体时，处于压缩状态的所述自膨胀假体被承载于所述第二细长轴上，且自所述膨胀假体的近端与所述固定头可拆卸式连接。
可选的，在所述的自膨胀假体的输送装置中，所述固定头包括：一主体及至少一个凸起部件，每个凸起部件均与所述主体弹性连接。
可选的，在所述的自膨胀假体的输送装置中，每个凸起部件通过弹性结构与所述主体连接，以使所述凸起部件可沿所述主体的径向进行伸缩运动。
可选的，在所述的自膨胀假体的输送装置中，每个凸起部件的近端具有导向面，以便于所述内侧外导管顺利通过。
可选的，在所述的自膨胀假体的输送装置中，所述内侧外导管的近端部分包括第三细长轴，所述远端部分包括金属鞘管，所述第三细长轴的近端与所述手柄可移动连接，至少部分所述金属鞘管呈镂空结构。
可选的，在所述的自膨胀假体的输送装置中，所述镂空结构具有镂空部，所述镂空部呈交替排列，或者螺纹排列。
可选的，在所述的自膨胀假体的输送装置中，所述外侧外导管的近端组件包括第四细长轴，所述远端组件包括高分子鞘管，所述第四细长轴的近端与所述手柄连接，且可在所述手柄的驱动下移动。
可选的，在所述的自膨胀假体的输送装置中，所述手柄包括：壳体和位于所述壳体中的第一控制机构和第二控制机构，所述内导管的近端、所述稳定管的近端分别与所述壳体固定连接，所述第一控制机构用于控制所述内侧外导管的运动；所述第二控制机构用于控制所述外侧外导管的运动。
可选的，在所述的自膨胀假体的输送装置中，所述壳体包括：第一壳体、第二壳体和第三壳体，所述第一控制结构位于所述第一壳体和所述第二壳体之间，所述第二控制结构位于所述第二壳体和所述第三壳体之间，所述内导管的近端与所述第一壳体固定连接，所述稳定管的近端与所述第三壳体固定连接。
可选的，在所述的自膨胀假体的输送装置中，所述第一控制机构包括：第一螺纹滑块，第一螺纹旋钮和第一锁紧部件；所述第一螺纹旋钮被限制于所述第一壳体和所述第二壳体之间，并可绕所述手柄的轴线进行旋转运动；所述第一螺纹滑块经配置与所述内侧外导管固定连接，并在所述第一螺纹旋钮的驱动下沿所述手柄轴向移动；所述第一锁紧部件用于控制所述第一螺纹旋钮的旋转运动。
可选的，在所述的自膨胀假体的输送装置中，所述第一螺纹旋钮具有第一螺纹腔体，所述第一螺纹滑块容置于所述第一螺纹腔体中并与所述第一螺纹旋钮螺纹连接；所述第一螺纹滑块套接并固定于所述内侧外导管的外侧；所述第一锁紧部件设置于所述第一螺纹旋钮和所述第二壳体之间并可沿所述手柄的轴向进行前后移动，驱使所述第一螺纹旋钮与所述第二壳体分离或结合。
可选的，在所述的自膨胀假体的输送装置中，所述第一锁紧部件包括：第一按钮部分、第一卡扣部分和连接所述第一按钮部分和所述第一卡扣部分的第一连接部分，所述第一按钮部分布置于所述第二壳体外并可沿所述第二壳体的轴向移动，所述第一连接部分从第二壳体外部延伸进入第二壳体内部，所述第 一卡扣部分位于连接部分靠近第一螺纹旋钮的端面并向所述第一螺纹旋钮方向延伸；所述第一螺纹旋钮与所述第一锁紧部件相邻的端面设置有第一对接凹槽；所述第一卡扣部分与所述第一对接凹槽相匹配。
可选的，在所述的自膨胀假体的输送装置中，还包括一对轴向平行于手柄的轴向的导向机构，所述导向机构的一端与所述第一壳体连接，另一端延伸通过所述第一螺纹滑块并与所述第二壳体固定连接，以限制所述第一螺纹滑块的旋转运动。
可选的，在所述的自膨胀假体的输送装置中，所述第二控制机构包括：第二螺纹滑块，第二螺纹旋钮和第二锁紧部件；所述第二螺纹旋钮被限制于所述第二壳体和所述第三壳体之间，并可绕所述手柄的轴线进行旋转运动；所述第二螺纹滑块被配置为与所述外侧外导管固定连接，并可在所述第二螺纹旋钮的驱动下沿所述手柄轴向移动；所述第二锁紧部件用于限制所述第二螺纹旋钮的旋转运动。
可选的，在所述的自膨胀假体的输送装置中，所述第二螺纹旋钮具有第二螺纹腔体，所述第二螺纹滑块延伸通过所述第二螺纹腔体后与所述外侧外导管连接，且所述第二螺纹滑块设有外螺纹以与所述第二螺纹旋钮螺纹连接；所述第二锁紧部件设置于所述第二螺纹旋钮与所述第二壳体之间并可沿所述手柄的轴向进行前后移动，驱使所述第二螺纹旋钮与所述第二壳体分离或结合。
可选的，在所述的自膨胀假体的输送装置中，所述第二锁紧部件包括：第二按钮部分、第二卡扣部分和连接所述第二按钮部分和所述第二卡扣部分的第二连接部分，所述第二按钮部分布置于所述第二壳体外并可沿所述第二壳体的轴向移动，所述第二连接部分从第二壳体外部延伸进入第二壳体内部，所述第二卡扣部分位于第二连接部分靠近第二螺纹旋钮的端面并向所述第二螺纹旋钮方向延伸；所述第二螺纹旋钮与所述第二锁紧部件相邻的端面设置有第二对接凹槽；所述第二卡扣部分与所述第二对接凹槽相匹配。
可选的，在所述的自膨胀假体的输送装置中，所述第三壳体的内壁上开设有沿所述壳体轴向分布的限转动凹槽，所述第二螺纹滑块的外侧设置有与所述凹槽相配合的限转动凸起件，所述限转动凸起件可沿所述限转动凹槽进行前后 移动。
可选的，在所述的自膨胀假体的输送装置中，所述自膨胀假体为主动脉瓣膜假体、二尖瓣瓣膜假体或三尖瓣瓣膜假体。
本发明还提供一种自膨胀心脏瓣膜假体的输送装置，包括导管和与所述导管连接的手柄，所述导管包括依次套接的内导管、内侧外导管、外侧外导管及稳定管；所述自膨胀心脏瓣膜假体的状态包括压缩状态、半释放状态和释放状态；所述内导管用于承载处于压缩状态的自膨胀心脏瓣膜假体；所述内侧外导管可以相对于所述内导管移动，且包括远端部分和近端部分，所述远端部分用于驱使所述自膨胀心脏瓣膜假体从半释放状态压缩至压缩状态；所述外侧外导管可以相对于所述内导管移动，且包括远端组件和近端组件，所述远端组件用于束缚所述自膨胀心脏瓣膜假体，以维持其压缩状态；所述远端组件的弯曲性能强于所述远端部分的弯曲性能，所述远端部分的抗拉、抗压性能强于所述远端组件的抗拉、抗压性能。
在本发明所提供的自膨胀假体的输送装置中，所述自膨胀假体的输送装置包括导管和与导管连接的手柄，导管包括依次套接的内导管、内侧外导管、外侧外导管及稳定管；内导管用于承载处于压缩状态的自膨胀假体，内侧外导管的远端部分用于驱使自膨胀假体从半释放状态压缩至压缩状态；外侧外导管的远端组件用于束缚自膨胀假体，以维持其压缩状态；远端组件弯曲性能强于远端部分的弯曲性能，远端部分的抗拉抗压性能强于远端组件的抗拉抗压性能；所述稳定管与所述内导管保持相对静止。基于外侧外导管能够进行自膨胀假体进行释放；基于内侧外导管能够将处于半释放状态的自膨胀假体进行再次压缩回收，以便进行重新释放；因此，本发明的同一装置能够兼具自膨胀假体回收和释放两个功能。进一步地，由于内侧外导管有套接于其外侧的外侧外导管保护，避免内侧外导管过立体弯曲通路时与血管的接触刺破血管的风险。
另一方面，将内侧外导管制备为部分呈镂空结构的金属鞘管，从而在牺牲部分掉抗压和抗拉能力的基础上获得一定的弯曲性能，从而确保输送装置可安全通过空间立体弯曲的通路，提升了整个装置的安全性能。
附图说明
图1是本发明一实施例中自膨胀假体的输送装置的结构示意图；
图2是本发明一实施例中导管的剖面示意图；
图3是本发明一实施例中手柄的剖面示意图；
图4是本发明一实施例中内导管的结构示意图；
图5是图4中固定头的剖面示意图；
图6是本发明一实施例中内侧外导管的结构示意图；
图7是本发明一实施例中套设有稳定管的外侧外导管的结构示意图；
图8是本发明一实施例中第一螺纹滑块的结构示意图；
图9a是本发明一实施例中第一锁紧部件的主视图；
图9b是本发明一实施例中第二锁紧部件的主视图；
图10是本发明一实施例中第二锁紧部件与第二壳体装配时的主视图；
图11是本发明一实施例中第二锁紧部件装配于第二螺纹旋钮和第二壳体之间时的主视图；
图12是图11的剖面图。
图中：
导管1；
内导管10；第一细长轴101；固定头102；主体102a；凸起部件102b；导向面102c；第二细长轴104；锥形头103；
内侧外导管20；第三细长轴201；金属鞘管202；
外侧外导管30；第四细长轴301；高分子鞘管302；
稳定管40；
自膨胀假体3；
手柄5；
壳体51；第一壳体510；第二壳体511；第三壳体512；
第一螺纹滑块504；第一螺纹旋钮505；导向机构507；
第一锁紧部件506；按钮部分506a，503a；卡扣部分506b，503b；连接部分506c，503c；
第二螺纹滑块501；第二螺纹旋钮502；第二锁紧部件503。
具体实施方式
以下结合附图和具体实施例对本发明提出的自膨胀假体的输送装置作进一步详细说明。根据下面说明和权利要求书，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
在本发明中，所述的“近端”、“近侧”是指靠近操作者的一端，相应的，“远端”、“远侧”是指远离操作者的一端。例如，在整个输送装置中，锥形头为导管的最远端，导管与手柄的连接处为导管的最近端。
图1为本发明的自膨胀假体的输送装置的结构示意图，如图1所示，所述自膨胀假体的输送装置包括：导管1和与所述导管1连接的手柄5；其中，如图2所示，所述导管1包括：依次套接的内导管10、内侧外导管20、外侧外导管30及稳定管40；所述自膨胀假体3的状态包括压缩状态、半释放状态和释放状态；所述内导管10用于承载处于压缩状态的自膨胀假体3；所述内侧外导管20可以相对于所述内导管10移动，且包括远端部分和近端部分，所述远端部分用于驱使自膨胀假体3从半释放状态压缩至压缩状态；所述外侧外导管30可以相对于所述内导管10移动，且包括远端组件和近端组件，所述远端组件用于束缚自膨胀假体3，以维持其压缩状态；所述远端组件弯曲性能强于所述远端部分的弯曲性能，所述远端部分的抗拉抗压性能强于所述远端组件的抗拉抗压性能；所述稳定管与所述内导管保持相对静止。
进一步，内导管10的近端与所述手柄5固定连接；所述稳定管40套接于所述外侧外导管30的外侧并与所述手柄5固定连接，以增强导管1在自膨胀假体3进行回收或释放过程中的稳定性及安全性。所述自膨胀假体例如为自膨胀心脏瓣膜假体，更具体为主动脉瓣膜假体、二尖瓣瓣膜假体或三尖瓣瓣膜假体。
本实施例的输送装置应用过程中，在所述手柄5、所述内导管10和所述外侧外导管30的配合作用下，可以实现对所述自膨胀假体3进行释放；在所述手柄5、所述内导管10和所述内侧外导管20的配合作用下，可以对处于半释放状 态的自膨胀假体进行再次压缩回收，以便进行重新释放，满足释放位置最佳的需求，减少释放后位置偏差造成的不良影响。具体的，输送自膨胀假体时，处于压缩状态的自膨胀假体被承载于所述内导管10上并被所述外侧外导管30所束缚；处于压缩状态的自膨胀假体被输送至目标位置附近时，所述外侧外导管30的近端组件相对所述内侧外导管20的近端部分移动，使得处于压缩状态的自膨胀假体处于半释放状态；待所述自膨胀假体被输送至目标位置时，所述外侧外导管30的近端组件相对所述内侧外导管20的近端部分回撤，使得处于半释放状态的自膨胀假体进一步释放直至完全处于释放状态。
请参考图4，其为本发明一实施例中内导管10的结构示意图。所述内导管10包括：依次连接的第一细长轴101、固定头102、第二细长轴104和锥形头103，所述第一细长轴101远离所述固定头102的一端与所述手柄5固定连接，所述第一细长轴101起固定支撑作用；输送自膨胀假体3时，处于压缩状态的自膨胀假体3被承载于所述第二细长轴104上，且自膨胀假体3的近端与所述固定头102可拆卸式连接。
其中，如图5所示，所述固定头102具体包括一主体102a及至少一个凸起部件102b。例如自膨胀假体为人工心脏瓣膜假体时，人工心脏瓣膜假体包括人工心脏瓣膜支架、瓣膜和裙边，其中人工心脏瓣膜支架包括支架主体和与所述支架主体连接的挂耳。通过将挂耳挂接于凸起部件102b上的方式，将人工心脏瓣膜与所述固定头102可拆卸式连接。其中，所有凸起部件102b均与所述主体102a弹性连接。具体的，每个凸起部件102b通过弹性结构与所述主体102a弹性连接，以使所述凸起部件102b可沿所述主体102a的径向进行伸缩运动，以利于在内侧外导管20和外侧外导管30相对内导管10进行移动时防止自膨胀假体产生脱钩现象。
此外，为了便于所述内侧外导管20向锥形头103方向移动时，顺利通过固定头，以束缚自膨胀假体。优选的，每个所述凸起部件102b的近端外侧都具有导向面102c。
请参考图6，其为本发明一实施例中内侧外导管20的结构示意图。所述内侧外导管20的近端部分包括第三细长轴201，所述内侧外导管20的远端部分包 括金属鞘管202，所述第三细长轴201与所述金属鞘管202连接，所述第三细长轴201远离所述金属鞘管202的一端与所述手柄5连接，且可在所述手柄5的驱动下移动，从而使得所述第三细长轴201可沿内导管10的轴向运动，且所述第三细长轴201被配置为不能径向旋转运动。优选的，所述第三细长轴201的材质为高分子材料或金属。由于金属材料制成的鞘管具有较高的抗拉和抗压能力，在金属鞘管202的作用下可以对自膨胀假体进行径向压握，因此，本实施例的内侧外导管20满足自膨胀假体的回收的需求。本发明对金属鞘管202的金属材料和制备方法的选择没有特别的限制，采用本领域现有的任一材料、任一制备方法即可。优选，采用镍钛合金通过编织或者切割的方法制备金属鞘管202。
其中，至少部分所述金属鞘管202呈镂空结构，优选的，所述镂空结构中的镂空部呈交替排列或者或螺纹排列，使金属鞘管202的抗压和抗拉能力降低，但其弯曲性能有所提高(即：牺牲部分抗压和抗拉能力，改善弯曲性)。这里的“交替排列”应理解为在轴向上包括有多排镂空部，每排镂空部由周向上均匀分布的多个镂空重复单元组成，相邻两排镂空部的镂空重复单元错开设置，位于同一平行于轴向的直线上的相邻两个镂空重复单元之间间隔一排镂空部，其中每个镂空重复单元可以包括一个或多个镂空单元。这里的“螺纹排列”应理解为在轴向上包括有多排镂空部，每排镂空部至少由一个镂空重复单元组成，从轴向投影每个镂空重复单元与相邻排的镂空重复单元之间重叠或呈一定角度，其中每个镂空重复单元可以包括一个或多个镂空单元。如此，金属鞘管202可在外侧外导管30的保护下进出主动脉弓等曲率半径小的通路，避免内侧外导管20过立体弯曲通路时与血管的接触刺破血管的风险；与此同时，内侧外导管20的金属鞘管202作用于自膨胀假体时，可满足对于装载和回收自膨胀假体时对于性能的需求。
请参考图7，其为本发明一实施例中套设有稳定管40的外侧外导管30的结构示意图。所述外侧外导管30的近端组件包括第四细长轴301，所述外侧外导管30的远端组件包括高分子鞘管302，所述第四细长轴301与高分子鞘管302连接，所述第四细长轴301远离所述高分子鞘管302的一端与所述手柄5连接，且可在所述手柄5的驱动下移动，使得所述第四细长轴301可沿内导管10的轴 向运动，且所述第四细长轴301被配置为不能径向旋转运动。高分子材料制备的鞘管具有良好的弯曲性能，尤其可空间立体弯曲，因此，本实施例的外侧外导管30可满足自膨胀假体的释放需求。本发明对高分子鞘管302的高分子材料和制备方法的选择没有特别的限制，采用本领域现有的任一材料、任一制备方法即可。优选，采用PEBA、PA、PU、TPE材料通过挤出成型的方法制备高分子鞘管302。本实施例中，稳定管40作用与现有技术中的稳定管作用类似，例如可以防止外管直接暴露在血管中在外管移动时损伤血管。因此，本实施例中的稳定管可以采用任一现有的稳定管。
请参考图3，其为本发明一实施例中手柄的剖面示意图。所述手柄5包括：壳体51和位于所述壳体51中的第一控制机构和第二控制机构，所述内导管10的近端、所述稳定管40的近端分别与所述壳体51固定连接，所述第一控制机构用于控制所述内侧外导管20的运动；所述第二控制机构用于控制所述外侧外导管30的运动，基于第一控制机构和第二控制机构的配合，可以实现自膨胀假体的从半释放状态至压缩状态，或者从压缩状态至半释放乃至释放状态，简化了操作过程。具体控制原理请结合后续关于第一控制机构和第二控制机构的具体结构进行理解。
继续参考图3，所述壳体51包括：第一壳体510、第二壳体511和第三壳体512，所述第一控制结构位于所述第一壳体510和所述第二壳体511之间，所述第二控制结构位于所述第二壳体511和所述第三壳体512之间，所述内导管10的近端与所述第一壳体510固定连接，所述稳定管40的近端与所述第三壳体512固定连接。
所述第一控制机构包括：第一螺纹滑块504，第一螺纹旋钮505和第一锁紧部件506；所述第一螺纹旋钮505被限制于所述第一壳体510和所述第二壳体511之间，并可绕所述手柄的轴线进行旋转运动(即所述第一螺纹旋钮505被配置为可沿所述手柄5的周向旋转，但不能轴向移动)；所述第一螺纹滑块504被配置为与所述内侧外导管20固定连接，并在所述第一螺纹旋钮505的驱动下沿所述手柄5的轴向移动；所述第一锁紧部件506用于限制所述第一螺纹旋钮505的旋转运动(即第一锁紧部件506可以决定第一螺纹旋钮505是否可以进行旋 转运动)。
其中，所述第一螺纹旋钮505具有第一螺纹腔体(所述第一螺纹腔体的体壁上具有内螺纹)，所述第一螺纹滑块504容置于所述第一螺纹腔体中并与所述第一螺纹旋钮505的螺纹连接(即所述第一螺纹滑块504具有与所述第一螺纹腔体的体壁上内螺纹相匹配的外螺纹)，所述第一螺纹滑块504套接并固定于所述内侧外导管20的外侧(具体为所述第一螺纹滑块504套接并固定于第三细长轴201远离所述金属鞘管202的一端)；所述第一锁紧部件506设置于所述第一螺纹旋钮505和所述第二壳体511之间并可沿所述手柄5的轴向进行前后移动，驱使所述第一螺纹旋钮505与所述第二壳体511分离或结合；其中，在所述第一螺纹旋钮505与所述第二壳体511分离时，所述第一螺纹旋钮505可以绕所述手柄5的轴向作旋转；在所述第一螺纹旋钮505与所述第二壳体511结合时，所述第一螺纹旋钮505和所述第二壳体511相当于一个整体(此时，所述第一锁紧部件506用于固定第一螺纹旋钮505的位置，进而制动第一螺纹滑块504)，两者不存在相对运动。
较佳的，为了使得第一螺纹滑块504只能沿手柄5的轴向移动而不能围绕手柄的轴线进行旋转，所述输送装置还设置有一对轴向平行于手柄5的轴向的导向机构507，所述导向机构507的一端与所述第一壳体510连接，另一端延伸通过所述第一螺纹滑块504，并与所述第二壳体511固定连接，以限制所述第一螺纹滑块504的旋转运动。如图8所示，所述第一螺纹滑块504沿其轴向开设有第一通孔、第二通孔和第三通孔，第一通孔为中心孔，所述内侧外导管20穿过所述第一通孔并固定于第一螺纹滑块504上，所述内导管10从内侧外导管20穿过并被固定于第一壳体510上，两个导向机构507分别贯穿第二通孔和第三通孔并被固定于第一壳体510、第二壳体511上，第一螺纹滑块504只能沿两个导向机构507移动，从而限制了第一螺纹滑块504发生旋转。
由于第一螺纹滑块504与第一螺纹旋钮505相互螺纹配合，且第一螺纹滑块504套接并固定于所述内侧外导管20的外侧，因此，当顺时针或逆时针旋转第一螺纹旋钮505时，会带动第一螺纹滑块504前进或后退(沿手柄5的轴向移动，将旋转运动转化为水平移动)，进而带动内侧外导管20前进或后退。
所述第二控制机构包括：第二螺纹滑块501、第二螺纹旋钮502和第二锁紧部件503；所述第二螺纹旋钮502被限制于所述第二壳体511和所述第三壳体512之间，且所述第二螺纹旋钮502被配置为可沿所述手柄5的周向(即绕所述手柄的轴线)旋转，但不能轴向移动。
所述第二螺纹滑块501被配置为与所述外侧外导管30固定连接，并在所述第二螺纹旋钮502的驱动下沿所述手柄5的轴向移动；所述第二锁紧部件503用于限制所述第二螺纹旋钮502的旋转运动。
所述第二螺纹旋钮502具有第二螺纹腔体，所述第二螺纹腔体的内壁上具有内螺纹，所述第二螺纹滑块501延伸通过所述第二螺纹腔体后与所述外侧外导管30连接，且所述第二螺纹滑块501设有外螺纹以与所述第二螺纹旋钮502螺纹连接。具体而言，所述第二螺纹滑块501的外壁上具有与所述第二螺纹腔体的内壁上的内螺纹相匹配的外螺纹，所述第二螺纹滑块501套接固定于所述外侧外导管30的第四细长轴301近端的外侧，形成一装配管。进一步，所述的装配管延伸通过所述第三壳体512的体腔，然后容纳于稳定管中，并延伸至远端。所述第二锁紧部件503设置于所述第二螺纹旋钮502和所述第二壳体511之间并可沿所述手柄5的轴向进行前后移动，驱使所述第二螺纹旋钮502与所述第二壳体511分离或结合。在所述第二螺纹旋钮502与所述第二壳体511分离时，所述第二螺纹旋钮502可以绕手柄5的轴线旋转；在所述第二螺纹旋钮502与所述第二壳体511结合时，所述第二螺纹旋钮502和所述第二壳体511相当于一个整体(此时，所述第二锁紧部件503用于固定第二螺纹旋钮502的位置，进而制动第二螺纹滑块501)，两者不存在相对运动。
较佳地，所述第三壳体512的内壁上开设有沿所述壳体轴向分布的限转动凹槽(图中未画出)，所述第二螺纹滑块501的外侧设置有与所述限转动凹槽相配合的限转动凸起件，所述限转动凸起件可沿所述限转动凹槽进行前后移动。所述限转动凹槽起到限制导向的作用，使得所述第二螺纹滑块501只能沿手柄5的轴向移动不能绕手柄5轴线周向旋转。
由于第二螺纹滑块501与第二螺纹旋钮502相互啮合，且所述第二螺纹滑块501的一端与所述外侧外导管30固定连接，因此，当顺时针或逆时针旋转第 二螺纹旋钮502时，会带动第二螺纹滑块501前进或后退(沿手柄5的轴向移动，将旋转运动转化为水平移动)，进而带动外侧外导管30前进或后退。
请参考图9a和图9b，图9a为本实施例中第一锁紧部件的主视图；图9b为本实施例中第二锁紧部件的主视图。
所述第一锁紧部件506包括：第一按钮部分506a、第一卡扣部分506b和连接所述第一按钮部分506a和所述第一卡扣部分506b的第一连接部分506c。结合图3所示，所述第一按钮部分506a布置于所述第二壳体511近端外侧，并可沿所述第二壳体511的轴向移动，所述第一连接部分506c从第二壳体511外部延伸进入第二壳体511内部，所述第一卡扣部分506a位于第一连接部分506c靠近第一螺纹旋钮505的端面并向所述第一螺纹旋钮505方向延伸(换言之，所述第一卡扣部分506a朝向第一螺纹旋钮505的端面)。所述第一按钮部分506a可沿所述第二壳体511的轴向移动，驱使所述第一卡扣部分506b与临近的所述第一对接凹槽分离或结合。优选的，所述第一卡扣部分506b两侧还设有第一稳定部分，所述稳定部分为弧状，以与第二壳体511近端的内壁配合，以增加第一锁紧部件轴向移动的稳定性。
所述第二锁紧部件503和第一锁紧部件506相似，包括：第二按钮部分503a、第二卡扣部分503b和连接所述第二按钮部分503a和所述第二卡扣部分503b的第二连接部分503c。区别在于，所述第二按钮部分503a布置于所述第二壳体511远端外侧并可沿所述第二壳体511的轴向移动，所述第二连接部分503c从第二壳体511外部延伸进入第二壳体511内部，所述第二卡扣部分503a位于连接部分503c靠近第二螺纹旋钮502的端面并向所述第二螺纹旋钮502方向延伸(即所述第二卡扣部分503a朝向第二螺纹旋钮502的端面)。
本实施例中，所述第一螺纹旋钮505与所述第一锁紧部件506相邻的端面的周向上设置有多个第一对接凹槽；所述第二螺纹旋钮502与所述第二锁紧部件503相邻的端面的周向上设置有多个第二对接凹槽，所述第一卡扣部分506a，第二卡扣部分503a分别与其临近的端面上的对接凹槽相匹配。
具体的，请参考图10，其为第二锁紧部件503与第二壳体511装配时的主视图。所述卡扣部分503a背离所述第二壳体511的端面。
请参考图11和图12，图11为第二锁紧部件503装配于第二螺纹旋钮和第二壳体之间时的立体视图；图12为图11的剖面图。所述第二按钮部分503a布置于所述第二壳体511远端的外侧，并可沿所述第二壳体511的轴向移动。所述第二连接部分503c从所述第二壳体511的外侧通过第二壳体511上的一凹槽，径向延伸至所述第二壳体511的内侧，所述第二卡扣部分506b两侧还设有第二稳定部分，所述稳定部分为弧状，以与第二壳体511远端的内壁配合。所述第二卡扣部分503a位于所述第二连接部分503c背离所述第二壳体511的端面，并朝向第二螺纹旋钮502的方向延伸。所述第二卡扣部分503a与第二螺纹旋钮502的端面上设置的第二对接凹槽卡接。
为了较好的理解本发明的自膨胀假体的输送装置的工作原理，下面以主动脉瓣膜假体为例，结合图2、图4、图6及图7详细阐述主动脉瓣膜假体的装载、释放和回收再释放的过程。
这里的“压缩状态”是指为了使自膨胀假体顺利通过人体管状器官(例如血管)进入目标位置，通过径向外力等手段使自膨胀假体处于径向被压缩的状态；
“释放状态”是指自膨胀假体到达目标位置，撤去外部束缚后，在目标位置展开的状态；
“半释放状态”是指自膨胀假体的一部分不再受到径向约束力开始展开，而另一部分仍然被束缚压缩的状态。
主动脉瓣膜假体的装载过程，即将释放状态的瓣膜假体压握为压缩状态的瓣膜假体：
主动脉瓣膜假体的装载是在体外冰水浴中并借助装载工具等辅助手段进行的。因此，使用外侧外导管30中的高分子鞘管302就可以很好的将压缩状态的主动脉瓣膜假体压握在固定头102与锥形头103之间的第二细长轴104上，此时，将金属鞘管202置于固定头102的后侧(金属鞘管202并未覆盖人工心脏瓣膜)。
借助装载工具将主动脉瓣膜假体的挂耳固定在固定头102的凸起部件102b上，正向旋转(顺时针或逆时针)第二螺纹旋钮502，使高分子鞘管302在第二 螺纹旋钮502的旋转作用下被推进，直至高分子鞘管302完全覆盖压缩状态的主动脉瓣膜假体并与锥形头103贴合，主动脉瓣膜假体的装载完毕。
主动脉瓣膜假体释放和回收再释放过程，即将压缩状态的瓣膜假体转化为半释放状态/释放状态的瓣膜假体：
本发明的核心思想：在主动脉弓等这样大迂回通路区域，为保证压缩状态的自膨胀假体的鞘管能顺利过弓，通常鞘管为了获取好的弯曲性能而牺牲掉抗压和抗拉能力，而自膨胀假体在体内释放一部分后变成半释放状态，由于释放位置不佳等诸多原因需要再次回收压握成压缩状态。此时外管尤其是鞘管部分需要很大的抗压能力。一般的材料或结构很难平衡管材的弯曲性能与抗拉、抗压之间的要求，因此需要在不同时间或者空间上使用不同性能的方法进而去解决这种矛盾。
请参考图2，输送装置过主动脉弓时，压缩状态的主动脉瓣膜假体是由外侧外导管30上的高分子鞘管302束缚的。此时，金属鞘管202位于固定头102后侧，高分子鞘管302具有良好的弯曲性能，并且可空间立体弯曲，因此可以确保输送装置安全过弓。
主动脉瓣膜假体到达指定病变位置后，反向旋转(相比人工心脏瓣膜的装载时旋转方向而言)第二螺纹旋钮502，回撤高分子鞘管302以释放主动脉瓣膜假体。主动脉瓣膜假体从流入道部分开始逐步释放，主动脉瓣膜假体由压缩状态转变为半释放状态，即主动脉瓣膜假体的一部分(例如流出道部分)不再受到束缚开始展开，而另一部分(例如流入道部分)仍然被高分子鞘管302所束缚被压缩。当主动脉瓣膜假体释放部分时，如果手术实施者发现主动脉瓣膜假体释放位置不理想，需要收回主动脉瓣膜假体重新调整释放位置。回收主动脉瓣膜假体，需要将主动脉瓣膜假体从半释放状态重新压握成压缩状态。这需要克服很大的阻力，因此需要使用抗压和抗拉能力更大的金属鞘管202回收压握。具体过程如下：
首先，推动第二锁紧部件503来制动外侧外导管30中的高分子鞘管302，正向旋转第一螺纹旋钮505，使金属鞘管202在第一螺纹旋钮505的旋转作用下被向远端推进，直至金属鞘管202压握主动脉瓣膜假体，将主动脉瓣膜假体从 半释放状态重新压握成压缩状态。虽然，金属鞘管202弯曲性能较差，但是其外侧有外侧外导管30的保护，避免过立体弯曲通路时与血管的接触刺破血管的风险；同时由于固定头102的凸起部件102b与固定头102的主体102a弹性连接，使所述凸起部件102b可沿所述主体102a的径向进行伸缩运动，可确保金属鞘管202顺利通过固定头102和高分子鞘管302贴合处。
接着，当主动脉瓣膜假体被完全压握在金属鞘管202内后，推动第一锁紧部件506来制动金属鞘管202，解除第二锁紧部件503对高分子鞘管302的制动，正向旋转第二螺纹旋钮502，推动高分子鞘管302前进至远端，以完全覆盖主动脉瓣膜假体。
接着，推动第二锁紧部件503制动高分子鞘管302，解除第一锁紧部件506对金属鞘管202的制动，反向旋转第一螺纹旋钮505，向近端撤回金属鞘管202。在金属鞘管202通过固定头102时，由于固定头102的凸起部件102b与固定头102的主体102a弹性连接，使所述凸起部件102b可沿所述主体102a的径向进行伸缩运动，可确保金属鞘管202顺利通过而不至于产生主动脉瓣膜假体脱钩现象。
最后，当金属鞘管202顺利回撤后，推动第一锁紧部件506制动金属鞘管202。在寻找到合适的释放位置后，解除第二锁紧部件503对高分子鞘管302的制动，即可重新定位再次释放主动脉瓣膜假体。
综上，在本发明所提供的自膨胀假体的输送装置中，所述自膨胀假体的输送装置包括导管和与导管连接的手柄，导管包括依次套接的内导管、内侧外导管、外侧外导管及稳定管；内导管用于承载处于压缩状态的自膨胀假体，内侧外导管的远端部分用于驱使自膨胀假体从半释放状态压缩至压缩状态；外侧外导管的远端组件用于束缚自膨胀假体，以维持其压缩状态；远端组件弯曲性能强于远端部分的弯曲性能，远端部分的抗拉、抗压性能强于远端组件的抗拉、抗压性能；所述稳定管与所述内导管保持相对静止。基于外侧外导管能够进行自膨胀假体进行释放；基于内侧外导管能够将处于半释放状态的自膨胀假体进行再次压缩回收，以便进行重新释放；因此，本发明的同一装置能够兼具自膨胀假体回收和释放两个功能。
进一步地，由于内侧外导管有套接于其外侧的外侧外导管保护，避免内侧外导管过立体弯曲通路时与血管的接触刺破血管的风险。
另一方面，将内侧外导管制备为部分呈镂空结构的金属鞘管，从而在牺牲部分掉抗压和抗拉能力的基础上获得一定的弯曲性能，从而确保输送装置可安全通过空间立体弯曲的通路，提升了整个装置的安全性能。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。例如，上述实施例中，外侧外导管采用纯高分子材料制备，内侧外导管采用纯金属材料制备，但是本领域技术人员应理解，外侧外导管和/或内侧外导管不限于采用以上材料制备，可以采用其他适用的材料，例如复合材料制备，具体而言，采用编织加强筋或者螺旋加强筋方法制备。

Claims (20)

  1. 一种自膨胀假体的输送装置，包括导管和与所述导管连接的手柄，其特征在于，所述导管包括依次套接的内导管、内侧外导管、外侧外导管及稳定管；
    所述自膨胀假体的状态包括压缩状态、半释放状态和释放状态；
    所述内导管，用于承载处于压缩状态的自膨胀假体；
    所述内侧外导管可以相对于所述内导管移动，且包括远端部分和近端部分，所述远端部分用于驱使所述自膨胀假体从半释放状态压缩至压缩状态；
    所述外侧外导管可以相对于所述内导管移动，且包括远端组件和近端组件，所述远端组件用于束缚所述自膨胀假体，以维持其压缩状态；
    所述远端组件的弯曲性能强于所述远端部分的弯曲性能，所述远端部分的抗拉、抗压性能强于所述远端组件的抗拉、抗压性能；
    所述稳定管与所述内导管保持相对静止。
  2. 如权利要求1所述的自膨胀假体的输送装置，其特征在于，所述内导管包括：从近端至远端依次连接的第一细长轴、固定头、第二细长轴和锥形头，所述第一细长轴的近端与所述手柄固定连接；输送所述自膨胀假体时，处于压缩状态的所述自膨胀假体被承载于所述第二细长轴上，且自所述膨胀假体的近端与所述固定头可拆卸式连接。
  3. 如权利要求2所述的自膨胀假体的输送装置，其特征在于，所述固定头包括：一主体及至少一个凸起部件，每个凸起部件均与所述主体弹性连接。
  4. 如权利要求3所述的自膨胀假体的输送装置，其特征在于，每个凸起部件通过弹性结构与所述主体连接，以使所述凸起部件可沿所述主体的径向进行伸缩运动。
  5. 如权利要求3所述的自膨胀假体的输送装置，其特征在于，每个凸起部件的近端具有导向面，以便于所述内侧外导管顺利通过。
  6. 如权利要求1所述的自膨胀假体的输送装置，其特征在于，所述内侧外导管的近端部分包括第三细长轴，所述远端部分包括金属鞘管，所述第三细长轴的近端与所述手柄可移动连接，至少部分所述金属鞘管呈镂空结构。
  7. 如权利要求6所述的自膨胀假体的输送装置，其特征在于，所述镂空结 构具有镂空部，所述镂空部呈交替排列，或者螺纹排列。
  8. 如权利要求1所述的自膨胀假体的输送装置，其特征在于，所述外侧外导管的近端组件包括第四细长轴，所述远端组件包括高分子鞘管，所述第四细长轴的近端与所述手柄连接，且可在所述手柄的驱动下移动。
  9. 如权利要求1所述的自膨胀假体的输送装置，其特征在于，所述手柄包括：壳体和位于所述壳体中的第一控制机构和第二控制机构，所述内导管的近端、所述稳定管的近端分别与所述壳体固定连接，所述第一控制机构用于控制所述内侧外导管的运动；所述第二控制机构用于控制所述外侧外导管的运动。
  10. 如权利要求9所述的自膨胀假体的输送装置，其特征在于，所述壳体包括：第一壳体、第二壳体和第三壳体，所述第一控制结构位于所述第一壳体和所述第二壳体之间，所述第二控制结构位于所述第二壳体和所述第三壳体之间，所述内导管的近端与所述第一壳体固定连接，所述稳定管的近端与所述第三壳体固定连接。
  11. 如权利要求10所述的自膨胀假体的输送装置，其特征在于，所述第一控制机构包括：第一螺纹滑块，第一螺纹旋钮和第一锁紧部件；所述第一螺纹旋钮被限制于所述第一壳体和所述第二壳体之间，并可绕所述手柄的轴线进行旋转运动；所述第一螺纹滑块经配置与所述内侧外导管固定连接，并在所述第一螺纹旋钮的驱动下沿所述手柄轴向移动；所述第一锁紧部件用于控制所述第一螺纹旋钮的旋转运动。
  12. 如权利要求11所述的自膨胀假体的输送装置，其特征在于，所述第一螺纹旋钮具有第一螺纹腔体，所述第一螺纹滑块容置于所述第一螺纹腔体中并与所述第一螺纹旋钮螺纹连接；所述第一螺纹滑块套接并固定于所述内侧外导管的外侧；所述第一锁紧部件设置于所述第一螺纹旋钮和所述第二壳体之间并可沿所述手柄的轴向进行前后移动，驱使所述第一螺纹旋钮与所述第二壳体分离或结合。
  13. 如权利要求12所述的自膨胀假体的输送装置，其特征在于，所述第一锁紧部件包括：第一按钮部分、第一卡扣部分和连接所述第一按钮部分和所述第一卡扣部分的第一连接部分，所述第一按钮部分布置于所述第二壳体外并可沿所述第二壳体的轴向移动，所述第一连接部分从第二壳体外部延伸进入第二 壳体内部，所述第一卡扣部分位于第一连接部分靠近第一螺纹旋钮的端面并向所述第一螺纹旋钮方向延伸；
    所述第一螺纹旋钮与所述第一锁紧部件相邻的端面设置有第一对接凹槽；
    所述第一卡扣部分与所述第一对接凹槽相匹配。
  14. 如权利要求11所述的自膨胀假体的输送装置，其特征在于，还包括一对轴向平行于手柄的轴向的导向机构，所述导向机构的一端与所述第一壳体连接，另一端延伸通过所述第一螺纹滑块并与所述第二壳体固定连接，以限制所述第一螺纹滑块的旋转运动。
  15. 如权利要求10所述的自膨胀假体的输送装置，其特征在于，所述第二控制机构包括：第二螺纹滑块，第二螺纹旋钮和第二锁紧部件；所述第二螺纹旋钮被限制于所述第二壳体和所述第三壳体之间，并可绕所述手柄的轴线进行旋转运动；所述第二螺纹滑块被配置为与所述外侧外导管固定连接，并可在所述第二螺纹旋钮的驱动下沿所述手柄轴向移动；所述第二锁紧部件用于限制所述第二螺纹旋钮的旋转运动。
  16. 如权利要求15所述的自膨胀假体的输送装置，其特征在于，所述第二螺纹旋钮具有第二螺纹腔体，所述第二螺纹滑块延伸通过所述第二螺纹腔体后与所述外侧外导管连接，且所述第二螺纹滑块设有外螺纹以与所述第二螺纹旋钮螺纹连接；所述第二锁紧部件设置于所述第二螺纹旋钮与所述第二壳体之间并可沿所述手柄的轴向进行前后移动，驱使所述第二螺纹旋钮与所述第二壳体分离或结合。
  17. 如权利要求16所述的自膨胀假体的输送装置，其特征在于，所述第二锁紧部件包括：第二按钮部分、第二卡扣部分和连接所述第二按钮部分和所述第二卡扣部分的第二连接部分，所述第二按钮部分布置于所述第二壳体外并可沿所述第二壳体的轴向移动，所述第二连接部分从第二壳体外部延伸进入第二壳体内部，所述第二卡扣部分位于第二连接部分靠近第二螺纹旋钮的端面并向所述第二螺纹旋钮方向延伸；
    所述第二螺纹旋钮与所述第二锁紧部件相邻的端面设置有第二对接凹槽；
    所述第二卡扣部分与所述第二对接凹槽相匹配。
  18. 如权利要求15所述的自膨胀假体的输送装置，其特征在于，所述第三 壳体的内壁上开设有沿所述壳体轴向分布的限转动凹槽，所述第二螺纹滑块的外侧设置有与所述凹槽相配合的限转动凸起件，所述限转动凸起件可沿所述限转动凹槽进行前后移动。
  19. 如权利要求1～18中任一项所述的自膨胀假体的输送装置，其特征在于，所述自膨胀假体为主动脉瓣膜假体、二尖瓣瓣膜假体或三尖瓣瓣膜假体。
  20. 一种自膨胀心脏瓣膜假体的输送装置，包括导管和与所述导管连接的手柄，其特征在于，所述导管包括依次套接的内导管、内侧外导管、外侧外导管及稳定管；
    所述自膨胀心脏瓣膜假体的状态包括压缩状态、半释放状态和释放状态；
    所述内导管，用于承载处于压缩状态的自膨胀心脏瓣膜假体；
    所述内侧外导管可以相对于所述内导管移动，且包括远端部分和近端部分，所述远端部分用于驱使所述自膨胀心脏瓣膜假体从半释放状态压缩至压缩状态；
    所述外侧外导管可以相对于所述内导管移动，且包括远端组件和近端组件，所述远端组件用于束缚所述自膨胀心脏瓣膜假体，以维持其压缩状态；
    所述远端组件的弯曲性能强于所述远端部分的弯曲性能，所述远端部分的抗拉、抗压性能强于所述远端组件的抗拉、抗压性能。
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