WO2023040323A1 - 人工瓣膜的输送系统、挡件及介入式输送装置 - Google Patents

人工瓣膜的输送系统、挡件及介入式输送装置 Download PDF

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Publication number
WO2023040323A1
WO2023040323A1 PCT/CN2022/093960 CN2022093960W WO2023040323A1 WO 2023040323 A1 WO2023040323 A1 WO 2023040323A1 CN 2022093960 W CN2022093960 W CN 2022093960W WO 2023040323 A1 WO2023040323 A1 WO 2023040323A1
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WIPO (PCT)
Prior art keywords
stopper
fluid channel
axis
inner tube
inflatable balloon
Prior art date
Application number
PCT/CN2022/093960
Other languages
English (en)
French (fr)
Inventor
蒋佳强
詹航敏
虞奇峰
秦涛
Original Assignee
上海纽脉医疗科技股份有限公司
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 CN202122253298.5U external-priority patent/CN216495868U/zh
Priority claimed from CN202111087123.XA external-priority patent/CN114259321A/zh
Application filed by 上海纽脉医疗科技股份有限公司 filed Critical 上海纽脉医疗科技股份有限公司
Publication of WO2023040323A1 publication Critical patent/WO2023040323A1/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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61M25/10—Balloon catheters

Definitions

  • the present application relates to the technical field of medical devices, in particular to an artificial valve delivery system, a stopper and an interventional delivery device.
  • Prior art delivery systems include an outer tube, an inner tube passing through the distal end of the outer tube, and an inflatable balloon positioned at the distal portion of the inner tube.
  • two stoppers are fixed on the inner tube, and the two stoppers are located inside the inflatable balloon, and one end of the inflatable balloon is fixed on the outer tube The distal end, the other end is fixed on the outer wall of the stopper at the distal end of the inner tube.
  • the gap between its peripheral wall and the two stoppers is too small, so that the inflation medium can only push the proximal end of the inflatable balloon
  • the gap between the stopper and the inflatable balloon can be increased, so that the inflation medium flows to the middle region and the distal region of the inflatable balloon.
  • the main purpose of the present application is to provide an artificial valve delivery system, a stopper and an interventional delivery device, so as to solve the problem of too slow flow of the expansion medium in the prior art.
  • the application provides a delivery system for an artificial valve, which includes an outer tube, an inner tube that penetrates inside the outer tube and protrudes from the distal end of the outer tube, an inflatable balloon, and an One end of the inflatable balloon is installed in the distal area of the outer tube, and the other end is installed in the distal area of the inner tube. ; the first stopper is closer to the distal end of the outer tube than the second stopper;
  • both the first stopper and the second stopper include a fixed part and a stop part arranged in the axial direction, and the fixed part is in the shape of a cylindrical tube structure, which is inserted and connected with the inner tube; the stopper is located in the section where the first stopper and the second stopper are close, and is a circumferentially closed ring structure, the stopper
  • the maximum radial dimension of at least the outer edge of its end to the axis of the fixed part is greater than the radius of the fixed part;
  • the side wall of the first stopper is provided with a first fluid channel or a second fluid channel; the side wall of the second stopper is provided with a first fluid channel; wherein, the first fluid channel is in the inner tube
  • the axial direction of the second fluid passage passes through the stopper part; the second fluid channel passes through from one end to the other end of the first stopper in the axial direction of the inner tube;
  • the part between the two stoppers and the two stoppers enclose the accommodating space of the artificial valve, so that the artificial valve in the compressed state is located at the position of the artificial valve.
  • the ends of the two stoppers can axially limit the artificial valve.
  • the axis of the first fluid channel is parallel to the axis of the inner tube, or one end of the first fluid channel located on the inner wall is farther from the inner tube than the other end.
  • the stopper has a straight cylindrical structure, the extension direction of the side wall of the stopper is parallel to the axis of the stopper, and the inner wall surface of the stopper and the inner tube There is a gap; the first fluid channel passes through from one end surface of the stopper part away from the fixing part to the other end surface thereof.
  • At least one of the first stopper and the second stopper further includes a conical tube-shaped connecting portion, the large-diameter end of the connecting portion is connected to the stopper, and the small-diameter end is connected to the stopper.
  • the fixed part is connected.
  • the annular structure includes a plurality of protruding structures arranged along the circumferential direction, and the recessed area between two adjacent protruding structures forms a concave structure, and the protruding structures are defined by the inner part of the annular structure.
  • the ring surface and the outer ring surface protrude toward the outside of the ring structure at the same time, and the concave structure is formed by the inner ring surface and the outer ring surface of the ring structure being recessed toward the inside of the ring structure.
  • the first fluid channel is arranged on the protruding structure; the second fluid channel part is arranged on the concave structure.
  • each of the concave structures is a V-shaped groove, and the adjacent groove walls of two adjacent V-shaped grooves form the convex structure, and the included angle at the peak of the convex structure is smaller than that of the concave structure Angle at the trough.
  • the present application also provides a stopper for an interventional delivery device for delivering an artificial valve or a stent to a patient, comprising an outer tube, an inner tube passing through the distal end of the outer tube , an inflatable balloon, two stoppers located in the inflatable balloon and fixed to the inner tube at intervals, the part of the inflatable balloon between the two stoppers and the two stoppers
  • the retaining member encloses an accommodating space for accommodating an artificial valve or a stent in a contracted state
  • the stopper includes a fixing part for insertion connection with the inner tube and a stopper part for limiting the position of the artificial valve or stent, and the stopper part is a circumferentially closed annular structure, so The maximum radial dimension from at least the outer edge of the end of the stopper to the axis of the fixed part is greater than the radius of the fixed part;
  • the side wall of the stopper is provided with a fluid channel, and the fluid channel is at least located in the stopper part, and the fluid channel passes through the stopper part or passes through the stopper part in the axial direction of the fixing part. An end far away from the fixing part passes through to an end of the fixing part far away from the stopper part.
  • the stopping part is in a straight cylindrical structure, and the fluid channel is not perpendicular to the axis of the fixing part.
  • the stopper has a tapered cylindrical structure, and the small end of the stopper is connected to the fixing part; the fluid channel includes a first fluid channel located at the stopper, and the first fluid channel is located at the stopper.
  • a fluid passage runs through from the inner wall surface to the outer wall surface of the stopper.
  • the axis of the first fluid channel is parallel to the axis of the fixed part; or the axis of the first fluid channel is inclined relative to the axis of the fixed part, and it is located at one end of the inner wall surface. The other end is away from the axis of the fixing part.
  • the blocking member is provided with a plurality of the fluid passages along the circumferential direction.
  • the present application also provides an interventional delivery device for delivering an artificial valve or a stent into a patient; including the stopper as described in any one of the above items.
  • the stoppers of the first stopper and the second stopper are in a closed structure in the circumferential direction.
  • the first fluid channel and the second fluid channel By setting the first fluid channel and the second fluid channel, when the expansion medium is passed between the inner tube and the outer tube After the annular cavity flows out, it can not only flow from the proximal area of the inflatable balloon to the middle and the distal area through the gap between the inflatable balloon and the outer peripheral surfaces of the first stopper and the second stopper, but also the inflation medium It can flow into the middle area of the inflatable balloon through the first fluid passage or the second fluid passage on the first stopper, and then flow into the distal end region of the inflatable balloon through the first fluid passage on the second stopper.
  • the medium channel formed by the first fluid channel and the second fluid channel is always in a connected state. Therefore, the middle area of the inflatable balloon, especially the distal area, does not need to wait until the proximal area is inflated enough to realize the smooth flow of the medium.
  • Circulation that is to say, the inflation medium can basically reach the proximal region, the middle region and the distal region of the inflatable balloon at the same time, which shortens the inflation time of the inflatable balloon and is conducive to the rapid progress of interventional therapy; and adopting this method
  • each area of the inflatable balloon can be gradually expanded at the same time. Therefore, all parts of the artificial valve will be expanded to the same degree as the inflatable balloon is gradually expanded, and the artificial valve will not be tilted.
  • Fig. 1 is a schematic structural view of a preferred embodiment of the delivery system of the present application
  • Fig. 2 is a partial sectional view of a preferred embodiment of the delivery system of the present application
  • Fig. 4 is a longitudinal sectional schematic diagram of the embodiment shown in Fig. 3;
  • Fig. 7 is a structural schematic diagram of yet another preferred embodiment of the first stopper and the second stopper in the conveying system of the present application;
  • the distal end and the proximal end are relative to the operator of the delivery system, the proximal end refers to the end close to the operator, and the distal end refers to the end far away from the operator, that is, to the operator.
  • the end extending into the patient's body is the distal end, and the end outside the body close to the operator is the proximal end.
  • the present application provides a delivery system for an artificial valve, which is used for delivering artificial organs or supports such as artificial valves or artificial stents to a treatment position of a patient.
  • the delivery system includes an outer tube 10, an inner tube 20 disposed inside the outer tube and protruding from the distal end of the outer tube 10, an inflatable balloon 30, and an inflatable balloon 30.
  • one end of the inflatable balloon 30 is installed on the distal region of the outer tube 10, which can be connected by bonding, welding, etc., and the other end is installed on the The distal end area of the inner tube 20; the first stopper 40 is closer to the far end of the outer tube 10 than the second stopper 50, specifically, the inner tube 20 is inserted into the outer tube 10, and an annular cavity is formed between the two The inner tube 20 protrudes from the distal end of the outer tube 10 , and the first baffle 40 and the second baffle 50 are installed in the area where the inner tube 20 protrudes from the outer tube 10 .
  • Both the first stopper 40 and the second stopper 50 include a fixed portion 42 and a stopper 41 arranged in the axial direction, the fixed portion 42 is connected with the inner tube 20, specifically, the fixed portion 42 has a cylindrical tubular structure, and is connected to the inner tube 20 Plug-in connection.
  • the stopper 41 is located in the section where the first stopper 40 and the second stopper 50 are close, that is to say, in the axial direction, for the first stopper 40, the stopper 41 is smaller than the fixed part 42 Closer to the second stopper 50 , for the second stopper 50 , its stop portion 41 is closer to the first stopper 40 than its fixing portion 42 .
  • each stopper portion 41 has a circumferentially closed annular structure, that is to say, the annular structure is continuous in the circumferential direction, as shown in FIG. 11 .
  • the maximum radial dimension from at least the outer edge of the end of the stopper 41 to the axis of the fixed part 42 is larger than the radius of the fixed part 42.
  • the stopper 41 at least its end The projected contour of is located outside the projected contour of the fixing part 42 .
  • the side wall of the first stopper 40 is provided with the first fluid channel 44 or the second fluid channel 45
  • the side wall of the second stopper 50 is provided with the first fluid channel 44
  • the first fluid channel 44 and the second fluid channel 45 forms a medium channel through which an expandable medium flows.
  • the first fluid channel 44 penetrates the stopper 41 in the axial direction of the inner tube 20
  • the second fluid channel 45 penetrates the entire first stopper 40 in the axial direction of the inner tube 20 .
  • One end passes through to the other end, that is, from the end of the stopper 41 on the first stopper 40 away from the fixed part 42 to the end of the fixed part 42 away from the stopper 41, that is to say, the first fluid channel 44 is only located at the stopper 40.
  • the stopper 41 and axially penetrates the stopper 41; the second fluid channel 45 is partly located at the stopper 41, partly located at the fixed part 42, and also located at the connection part 43 when the connection part 43 (detailed below) is included, That is, the second fluid channel 45 is disposed on the entire first blocking member 40 . As shown in FIG.
  • the second baffle 50 is only provided with a medium flow channel on its stopper 41
  • the first baffle 40 may only be provided with a medium flow channel on the stopper 41 , or may be provided on both the stopper 41 and the stopper 41 .
  • Medium flow channels are arranged on the fixed parts.
  • the portion between the two stoppers 41 and the two stoppers 41 enclose the accommodating space of the artificial valve, so that the artificial valve in the compressed state is located in the accommodating space.
  • the ends of the two stoppers 41 realize axial limitation of the artificial valve. That is to say, the inflatable balloon 30 has a contracted state and an inflated state.
  • the inflatable balloon 30 can be expanded at least in the radial direction, so that the artificial valve located thereon Placed in the patient's body; in the contracted state, the artificial valve can be installed on the outside of the inflatable balloon 30, at this time, the two end surfaces of the artificial valve and the end surfaces of the two stoppers 41 are basically attached.
  • each area of the inflatable balloon 30 can basically expand gradually at the same time, therefore, all parts of the artificial valve will follow the inflatable
  • the gradual expansion of the balloon expands to the same extent, and does not cause the artificial valve to tilt, so that the axial displacement of the artificial valve during the expansion of the inflatable balloon can be avoided as much as possible, thereby improving the placement position of the artificial valve in the patient's body Accuracy, increasing surgical quality and success rate.
  • the positioning accuracy of the artificial valve becomes poor; when the artificial valve is installed in the delivery system, before entering the patient or when it is transported in the patient's body, multiple finger-like structures are also prone to shaking and deformation in the circumferential and axial directions, resulting in The artificial valve slides; and the strength of the finger-like structure is weak, and it is easily deformed when pressed by the end of the artificial valve, which affects the positioning accuracy of the artificial valve.
  • the stop portion with a circumferentially closed annular structure, and the first fluid channel 44 and the second fluid channel 45 provided on the side wall of the stopper have improved the strength of the stop portion 41, which can Avoiding the reduction of the strength of the stopper 41 due to the provision of fluid channels on the side walls of the first stopper 40 and the second stopper 50, which affects the displacement of the artificial valve during the transmission process, and enables the expansion medium to reach as much as possible at the same time Regions of the inflatable balloon 30.
  • the stopper 41 can be a tapered cylindrical structure, a straight cylindrical structure or other special-shaped structures, as long as the end face and the end face of the artificial valve have an overlapping area in the axial direction of the fixing part 42, the axial direction of the artificial valve can be realized. limit.
  • the small end of part 41 is connected with fixed part 42, and in this embodiment, the outer contour of the big end (i.e. end part) of stop part 41 is positioned at the outer periphery of fixed part 42, and the outer contour of inner and outer wall can be positioned at fixed part 42.
  • Outer circumference, the small end coincides with the outer circumference of the fixing part 42, adopting this structure, more space can be left between the proximal end region of the inflatable balloon 30 and the first stopper 40, so that the inflation medium can be expanded more quickly. into each first fluid channel 44 or second fluid channel 45 .
  • an opening of the first fluid channel 44 can be provided on the end surface of the stopper 41 away from the fixed part 42, or on the inner wall of the stopper 41 .
  • the side wall of the tapered cylindrical structure does not need to be too thick, so that the radial compressibility of the stopper 41 is easier, which further facilitates the installation of the first stopper 40 and the second stopper.
  • the expansion medium ejected from the first fluid channel 44 of the first stopper 40 can flow toward the second stopper 50 faster; and the middle area of the inflatable balloon 30 is surrounded by an artificial valve,
  • the force required for inflation will be greater than the distal and proximal regions, and the first fluid channel 44 adopting this oblique arrangement, since the injection direction of the first fluid channel 44 is towards the middle area of the inflatable balloon 30, therefore , can form a certain injection effect on this area, and then make this area expand better.
  • the stopper 41 has a straight cylindrical structure, such as the first stopper 40 or the second stopper 50 is a stepped structure, if the first fluid channel 41 passes through the stopper 41 in the thickness direction of the side wall, the stopper 41
  • the gap between the outer wall surface of the inflatable balloon 30 and the inflatable balloon 30 is relatively small, which is not conducive to the rapid entry of inflation fluid into the first fluid channel 41.
  • the first fluid channel 44 is away from the stopper 41.
  • One end surface of the fixing part 42 passes through to the other end surface, the opening at one end of the first fluid channel 44 is located on the end surface of the stopper 41 away from the fixing part 42, and the opening at the other end is located on the stepped surface of the stepped structure, so that when the inflatable When the medium flows to the outer periphery of the fixing part 42 , it can quickly enter the first fluid channel 44 .
  • the axis of the first fluid channel 44 may be parallel to the axis of the inner tube 20, that is, the first fluid channel 44 extends along the direction of the generatrix parallel to the outer wall (or the direction of the generatrix of the inner wall), that is, the first The axis of the fluid channel 44 is parallel to the axis of the inner tube 20; the axis of the first fluid channel 44 may also form a certain angle with the axis of the inner tube 20, that is, the axis of the first fluid channel 44 is inclined relative to the axis of the fixed part 42 The latter is preferred, and the first fluid channel 44 is located at the end of the stopper 41 away from the fixed part 42 than the other end is farther away from the inner tube 20, as shown in FIG.
  • the expansion medium can enter the first fluid passage 44 faster, and form a spray effect on the middle area of the inflatable balloon 30, thereby overcoming the expansion of the artificial valve to the middle area.
  • the binding force makes the area more prone to expansion.
  • the first fluid channel 44 can also be arranged so that the end of the stopper 41 away from the fixing part 42 is closer to the inner tube 20 than the other end.
  • the first stopper 40 can also be provided with a second fluid passage 45, and if the first stopper 40 is provided with a second fluid passage 45, the second fluid passage 45 will flow from the stopper
  • the end surface of the fixing portion 41 away from the fixing portion 42 penetrates to the end surface of the fixing portion 42 away from the stop portion 41 , as shown in FIG. 8 and FIG. 10 .
  • the axis of the second fluid passage 45 can be parallel to the axis of the fixing part 42 , preferably, the axis of the second fluid passage 45 is inclined relative to the axis of the fixing part 42 and is located at one end of the stopper 41 The other end is away from the axis of the fixed part 42, that is, the opening of the second fluid channel 45 located at the stopper part 41 is farther away from the inner tube 20 in the radial direction than the other opening, so that the second fluid channel 45 from the first stopper 40
  • the ejected inflation medium can form a certain injection effect on the middle area of the inflatable balloon 30 (that is, the area where the artificial valve is installed), and the injection force can also overcome the compression force of the artificial valve, thereby enabling this area to better swell.
  • the structures of the stoppers 41 of the first stopper 40 and the second stopper 50 can be the same or different, for example, the stoppers 41 of both can be in the shape of a tapered cylinder or a straight cylinder. structure; as another example, the stopper 41 of the first stopper 40 is a tapered cylindrical structure, and the stopper 41 of the second stopper 50 is a straight cylindrical structure; another example is that the stopper 41 of the first stopper 40 is The structure is straight, and the stop portion 41 of the second stopper 50 is in the shape of a cone.
  • the stopper 41 has a straight cylindrical structure, since the stopper 41 needs to act as an axial limit on the artificial valve, its outer diameter is set relatively large, and the fixing part 42 only needs to be fixedly connected with the inner tube 20 , the outer diameter of which can be set relatively small, so that a direct change from a larger radial dimension to a smaller radial dimension may easily cause the first stopper 40 or the second stopper 50 to break.
  • at least one of the first stopper 40 and the second stopper 50 further includes a The connecting portion 43, as shown in Fig. 9 and Fig.
  • only the first stopper 40 may include interconnected stoppers 41, connecting portions 43 and fixing portions 42, while the second stopper 50 includes interconnected stoppers part 41 and fixing part 42; or only the second stopper 50 includes the stopper part 41, the connecting part 43 and the fixing part 42 connected to each other, while the first stopper 40 includes the stopper part 41 and the fixing part 42 connected to each other; Both of them may also include a stopper portion 41 , a connecting portion 43 and a fixing portion 42 connected to each other.
  • By adding the connecting portion 43 it plays a transitional role between the stop portion 41 and the fixing portion 42, which can improve the fracture resistance strength of the first stopper 40 or the second stopper 50, and improve the reliability of the entire transmission system.
  • the connecting portion 43 can be a circular tubular structure, that is, its cross section is ring-shaped. At this time, half of the outer diameter of the circular tubular structure is less than the maximum radial distance between the stopper 41 and the axis of the inner tube 20, and greater than the fixed diameter. Half of the outer diameter of part 42; there may be a gap between the inner wall surface of the circular tubular structure and the inner tube 20, or it may be directly attached. In order to facilitate assembly, a gap is left between the connecting part 43 and the inner tube 20, that is, the first Only the fixing portion 42 of the first stopper 40 and the second stopper 50 is in contact with the inner tube 20 . In another embodiment, as shown in Fig. 9 and Fig.
  • the connecting part 43 has a conical tubular structure, the cross section of the connecting part 43 is circular, the inner and outer rings are respectively circular, and the large-diameter end of the connecting part 43 is connected to the The stop portion 41 is connected, and the small-diameter end is connected with the fixed portion 42. That is to say, the outer wall surface of the connecting portion 43 is a conical surface, and the inner wall surface is also a conical surface. The transition between the stopping part 41 and the fixing part 42 is realized, and the damage to the blood vessel wall can be reduced during transmission in the patient's body.
  • the connecting portion 43 can also be formed into a pyramidal tubular structure, that is, both the inner wall surface and the outer wall surface are pyramidal surfaces.
  • the first stopper 40 can be provided with a plurality of first fluid passages 44 or second fluid passages 45 along the circumferential direction;
  • a plurality of first fluid passages 44 may be arranged in the circumferential direction, so as to further enable the inflation medium to reach various regions of the inflatable balloon 30 in the axial direction more quickly, and to enable the inflatable balloon 30 to be able to reach everywhere in the circumferential direction. Receive a more uniform force exerted by the swelling medium.
  • the cross-section of the stopper 41 can be a ring structure, that is, the inner ring and the outer ring of the cross-section of the stopper 41 are both circular, and when the stopper 41 is a straight cylindrical structure, the outer ring surface Both the outer ring surface and the inner ring surface are cylindrical surfaces; when the stopper 41 is a tapered cylindrical structure, both the outer ring surface and the inner ring surface are conical surfaces.
  • the annular structure includes a plurality of protruding structures 411 arranged along the circumferential direction, and two adjacent protruding structures
  • the recessed area between 411 forms a recessed structure 412
  • the recessed structure 412 penetrates the entire stopper 41 in the axial direction, which can be penetrated in a direction parallel to the axial direction (such as when the stopper 41 is a straight cylindrical structure), or it can be Penetrating along the oblique and axial directions (such as in the case of a tapered cylindrical structure)
  • the protruding structure 411 is formed by the inner ring surface and the outer ring surface of the annular structure protruding away from the inner tube 20 at the same time
  • the concave structure 412 is formed by The inner ring surface and the outer ring surface of the annular structure are sunken toward the direction close to the inner pipe 20 at the same time, as shown in FIG.
  • the stopper 41 is either a convex structure 411 or a concave structure 412 .
  • the peaks of the protruding structure 411 are equal in size to the axis of the stopper 41 (that is, the axis of the inner tube 20 ) in the axial direction, that is to say, the protruding structure 411
  • the straight line (or line segment) or the tangent plane formed by the peaks of the protrusions are parallel to the axis of the stopper 41;
  • the axes of 41 form an included angle, so that the entire stopper 41 has a petal-shaped structure.
  • the size of the crests of the protruding structure 411 along the axial direction to the axis of the stopper 41 is gradual, that is to say, the straight line formed by the crests of the protruding structure 411 (or a line segment) or the tangent plane is set obliquely to the axis of the stopper 41.
  • the size of the trough of the concave structure 412 along the axial direction to the axis of the stopper 41 is gradually changing, that is to say, the concave structure
  • the straight line (or line segment) or tangential plane formed by the troughs of 412 is inclined to the axis of the stopper 41 .
  • the concave structure 412 of the inflatable balloon 30 flows to the middle region and the distal region, therefore, when the first fluid channel 44 is arranged on the convex structure 411, a fluid can be formed on both the convex structure 411 and the concave structure 412.
  • the channel, and then the time for the inflation medium to reach each area of the inflatable balloon 30 is shortened as much as possible, so as to improve the consistency of inflation everywhere.
  • the wall thickness of the stopper located inside the recessed structure 412 can also be increased, that is, the annular structure includes a support ring located on the inner ring, a raised structure 411 and a recess arranged on the outside of the support ring.
  • the structure 412 such as the annular structure, includes two parts arranged radially.
  • the inner part is a cylindrical structure (ie, a support ring), and the outer part includes a convex structure 411 and a concave structure 412.
  • the first fluid channel 44 may be provided on the support ring.
  • the guide member 60 has a connecting hole axially through, and the distal end of the inner tube 20 protrudes from the second stopper 50 and is inserted into the connection hole; the fixing portion 42 of the second stopper 50 The end surface is contacted and connected with the end surface of the guide member 60. With this end surface contact method, the second stopper 50 does not need to be provided with a special installation part.
  • the processing difficulty can be reduced, the length of the second stopper 50 can be reduced, and the overall The axial dimension of the delivery system at the distal end, and reduce material costs; moreover, compared with the structure in which the guide 60 is inserted into the installation hole, the guide 60 of this structure does not need to be intentionally made smaller than the size of the installation hole, that is, The guide piece 60 does not necessarily have a stepped shaft structure, and the second stopper 50 does not need to be provided with a thin-walled installation part, and the connection can be realized directly through end surface bonding, which further reduces the difficulty of processing.
  • the outer diameter of the fixing part 42 is equal to the maximum outer diameter of the guide part 60, so that when the inflatable balloon 30 is connected to the fixing part 42 and the guide part 60 at the same time, a stepped connection structure will not be caused, thereby avoiding the The presence of the stepped structure affects the sealability of the inflatable balloon 30 .
  • the guide 60 is provided with a connection hole; the end of the fixing portion 42 of the second stopper 50 away from the stopper 41 is plugged and connected to the connection hole, and the distal end of the inflatable balloon 30 passes through the guide 60
  • the inflatable balloon 30 is connected to the distal end area of the inner tube 20 through the guide 60, and this kind of plug-in connection structure can reduce the distance between the guide 60 and the second tube.
  • the overall length of the second stopper 50 after assembly can ensure the tightness of the inflatable balloon 30 at the distal end.
  • the connection hole 61 can be a stepped hole, and the fixing part 42 of the second stopper 50 is inserted into the large hole of the connection hole.
  • the second fluid channel 45 is partly located at the stopper 41, partly located at the fixed part 42, and when the connection part 43 (detailed below) is included, it is also located at the connection part 43, that is, the second
  • the second fluid channel 45 is provided on the entire first stopper 40, and the second fluid channel 45 penetrates the entire stopper in the axial direction of the fixed part 42, and penetrates from the end of the stop part 41 away from the fixed part 42 to the fixed part 42. The end away from the stopper 41 .
  • the penetration in the axial direction mentioned here is not limited to the penetration in the axial direction, and it can also penetrate in other directions.
  • the penetration direction can be inclined relative to the axial direction of the fixing part 42, that is, as described below
  • the through direction is inclined to the axial direction of the fixing part 42 .
  • both the first stopper 40 and the second stopper 50 include an axially connected fixed portion 42 and a stopper 41 , and the fixed portion 42 is connected to the inner tube 20 , specifically, inserted into the inner tube 20 .
  • the stopper 41 is located in the section where the first stopper 40 and the second stopper 50 are close.
  • the part between the two stoppers 41 and the two stoppers 41 enclose the accommodating space of the artificial valve or stent, and the artificial valve or stent in the compressed state
  • the two end surfaces of the artificial valve or stent respectively have overlapping areas with the end surfaces of the adjacent stoppers 41, so that the artificial valve or stent in the compressed state is located in the
  • the ends of the two stoppers 41 realize the axial limitation of the artificial valve or the stent. That is to say, the inflatable balloon 30 has a contracted state and an inflated state.
  • the above-mentioned stopper, the stopper 41 is in a closed structure in the circumferential direction.
  • the first fluid channel 44 and the second fluid channel 45 By setting the first fluid channel 44 and the second fluid channel 45, after it is installed in the delivery device, when the expansion medium is passed between the inner tube 20 and the outer tube 10 After the annular cavity between the inflatable balloons 30 flows out, it can not only flow from the proximal end region of the inflatable balloon 30 to the middle and distal ends through the gap between the inflatable balloon 30 and the first stopper 40 and the outer peripheral wall of the second stopper 50 area, and the inflation medium can flow into the middle area of the inflatable balloon 30 through the first fluid channel 44 or the second fluid channel 45 on the first stopper 40, and then pass through the first fluid channel 44 on the second stopper 50 Flowing into the far-end area of the inflatable balloon 30, because the medium channel formed by the first fluid passage 44 and the second fluid passage 45 is always in a communication state, therefore, the middle area of the inflatable balloon 30, especially the distal-end area is not It is
  • the stopper 41 in order to allow the inflation medium to reach all areas of the inflatable balloon 30 substantially simultaneously, is arranged as a plurality of elastic finger-like structures, that is, the fixing portion 42 is connected with a plurality of fingers arranged at intervals at the same time.
  • the inflation medium can also flow to the middle area and the distal end area of the inflatable balloon 30 through the gap between the two elastic fingers.
  • the elastic fingers are separated from each other, and it is a cantilever structure, which has a large degree of freedom in all directions. During transportation, etc., it is easy to shake, and even it will be deformed by vibration, which will cause deformation during later use.
  • the positioning accuracy of the artificial valve or stent becomes poor; when the delivery device is installed with the artificial valve or stent, before entering the patient or when it is transported in the patient's body, multiple finger-like structures are also prone to shaking in the circumferential and axial directions. Deformation, causing the artificial valve or stent to slide; and the strength of this finger-like structure is weak, and it is also easy to deform when pressed by the end of the artificial valve or stent, which affects the positioning accuracy of the artificial valve or stent.
  • the stopper adopts a circumferentially closed ring-shaped stopper, and the first fluid channel 44 and the second fluid channel 45 are provided on the sidewall of the stopper, which improves the strength of the stopper 41.
  • the pipeline axis of the first fluid channel 44 is parallel to the axis of the fixed part 42, as shown in FIG.
  • the other end is far away from the axis of the fixing part 42, that is, away from the inner shaft 20, and the opening of the first fluid channel 44 on the inner wall is farther from the inner tube 20 than the opening on the outer wall.
  • the expansion medium ejected from a fluid channel 44 can flow toward the second stopper 50 faster; and the middle area of the inflatable balloon 30 is surrounded by artificial valves or stents, and the force required for expansion will be greater than that of the distal end area and the proximal end area.
  • the first fluid channel 44 adopting this oblique arrangement, because the injection direction of the first fluid channel 44 is towards the middle area of the inflatable balloon 30, therefore, a certain injection effect can be formed there, thereby making the The area is better able to swell.
  • the stopper 41 has a straight cylindrical structure, and the sidewall of the stopper 41 extends in a direction parallel to the axis of the fixed part 42, as shown in Figures 5, 6, 8-10,
  • the maximum radial dimension of the stopping portion 41 to the axis of the fixing portion 42 along the axial direction is the same, and the stopping portion 41 also has an inner wall surface and an outer wall surface, and the extension directions of the inner wall surface and the outer wall surface are parallel to the inner tube 20.
  • the generatrices of the two are parallel to the axis of the inner tube 20, in this embodiment, the outer contours of each part of the stopper 41 in the entire axial direction are located on the outer periphery of the fixed part 42, in order to make the stopper 41 more It is easy to achieve radial compressibility, and there is a gap between the inner wall surface of the straight cylindrical structure and the inner tube 20. Adopting this straight cylindrical structure can further increase the strength of the stop part 41 in the axial direction, and better improve the stop The axial limit effect of the part on the artificial valve or stent.
  • the stopper 41 has a straight cylindrical structure, that is, when the stopper is a stepped structure, if the first fluid channel 44 penetrates the stopper 41 in the thickness direction of the side wall, the outer wall surface of the stopper 41 and the inflatable balloon 30 The gap between them is relatively small, which is not conducive to the rapid entry of inflation fluid into the first fluid channel 44.
  • the first fluid channel 44 penetrates from one end surface of the stopper 41 away from the fixed part 42 to the other.
  • the first fluid channel 44 extends along the generatrix of the outer wall surface or the generatrix of the inner wall surface, the opening at one end is located at the end surface of the stopper 41 away from the fixing portion 42, and the opening at the other end is located at the step of the stepped structure. On the surface, in this way, when the expansion medium flows to the outer periphery of the fixing part 42 , it can quickly enter the first fluid passage 44 .
  • the axis of the first fluid channel 44 may be parallel to the axis of the fixing portion 42, that is, the first fluid channel 44 extends along the direction of the generatrix parallel to the outer wall (or the direction of the generatrix of the inner wall), that is, the first The axis of the fluid channel 44 is parallel to the axis of the fixed part 42; it can also be at a certain angle, that is, the axis of the first fluid channel 44 is inclined relative to the axis of the fixed part 42, preferably the latter, and the first fluid channel 44 is located at One end of the stopper 41 away from the fixed part 42 is farther away from the inner tube 20 than the other end, as shown in FIG.
  • the expansion medium can enter the first fluid channel 44 more quickly, and form a spraying effect on the middle area of the inflatable balloon 30, thereby overcoming the restraining force of the artificial valve or stent on the expansion of the middle area, making the area easier to expand.
  • the first fluid channel 44 can also be arranged so that the end of the stopper 41 away from the fixing part 42 is closer to the inner tube 20 than the other end.
  • the first stopper 40 can also be provided with a second fluid passage 45, and if the first stopper 40 is provided with a second fluid passage 45, the second fluid passage 45 will flow from the stopper
  • the end surface of the fixing portion 41 away from the fixing portion 42 penetrates to the end surface of the fixing portion 42 away from the stop portion 41 , as shown in FIG. 8 and FIG. 10 .
  • the axis of the second fluid passage 45 can be parallel to the axis of the fixing part 42 , preferably, the axis of the second fluid passage 45 is inclined relative to the axis of the fixing part 42 and is located at one end of the stopper 41 The other end is away from the axis of the fixed part 42, that is, the opening of the second fluid channel 45 located at the stopper part 41 is farther away from the inner tube 20 in the radial direction than the other opening, so that the second fluid channel 45 from the first stopper 40
  • the ejected inflation medium can form a certain injection effect on the middle area of the inflatable balloon 30 (that is, the area where the artificial valve or stent is installed), and the injection force can also overcome the compression force of the artificial valve or stent, thereby making the area able to expand better.
  • the distance between the axis of the first fluid channel 44 and the axis of the second fluid channel 45 and the axis of the fixed part 42 is 0° ⁇ 30°, such as 0°, 5°, 10°, 15°, 20°, 25°, 28°, 30°, etc.
  • the injection effect of the inflation medium emitted from the channel 45 on the middle region of the inflatable balloon 30 is more conducive to the inflation of the middle region of the inflatable balloon 30 .
  • the stopper 41 has a straight cylindrical structure
  • the stopper 41 since the stopper 41 needs to act as an axial limit on the artificial valve or stent, its outer diameter is set relatively large, while the fixing part 42 only needs to be in contact with the inner
  • the pipe 20 can be fixedly connected, and its outer diameter can be set relatively small, so that it is directly transformed from a larger radial dimension to a smaller radial dimension, which will easily cause the first stopper 40 or the second stopper 50 to break out. fracture.
  • at least one of the first stopper 40 and the second stopper 50 further includes a The connecting portion 43, as shown in Fig. 9 and Fig.
  • only the first stopper 40 may include interconnected stoppers 41, connecting portions 43 and fixing portions 42, while the second stopper 50 includes interconnected stoppers part 41 and fixing part 42; or only the second stopper 50 includes the stopper part 41, the connecting part 43 and the fixing part 42 connected to each other, while the first stopper 40 includes the stopper part 41 and the fixing part 42 connected to each other; Both may also include a stopper portion 41 , a connecting portion 43 and a fixing portion 42 connected to each other.
  • By adding the connecting portion 43 it plays a transitional role between the stop portion 41 and the fixing portion 42, which can improve the fracture resistance strength of the first stopper 40 or the second stopper 50, and improve the reliability of the entire transmission system.
  • the connecting portion 43 can be a circular tubular structure, that is, its cross section is ring-shaped. At this time, half of the outer diameter of the circular tubular structure is less than the maximum radial distance between the stopper 41 and the axis of the inner tube 20, and greater than the fixed diameter. Half of the outer diameter of part 42; there may be a gap between the inner wall surface of the circular tubular structure and the inner tube 20, or it may be directly attached. In order to facilitate assembly, a gap is left between the connecting part 43 and the inner tube 20, that is, the first Only the fixing portion 42 of the first stopper 40 and the second stopper 50 is in contact with the inner tube 20 . In another embodiment, as shown in Fig. 9 and Fig.
  • the connecting part 43 has a conical tubular structure, the cross section of the connecting part 43 is circular, the inner and outer rings are respectively circular, and the large-diameter end of the connecting part 43 is connected to the The stop portion 41 is connected, and the small-diameter end is connected with the fixed portion 42. That is to say, the outer wall surface of the connecting portion 43 is a conical surface, and the inner wall surface is also a conical surface. The transition between the stopping part 41 and the fixing part 42 is realized, and the damage to the blood vessel wall can be reduced during transmission in the patient's body.
  • the connecting portion 43 can also be formed into a pyramidal tubular structure, that is, both the inner wall surface and the outer wall surface are pyramidal surfaces.
  • a plurality of first fluid passages 44 or second fluid passages 45 may be provided on the stopper in the circumferential direction, so as to further enable the inflation medium to reach each axial direction of the inflatable balloon 30 more quickly. area, and enable the inflatable balloon 30 to receive a more uniform force exerted by the inflation medium everywhere in the circumferential direction.
  • the structures of the stoppers 41 of the first stopper 40 and the second stopper 50 can be the same or different, for example, the stoppers 41 of both can be in the shape of a tapered cylinder or a straight cylinder. structure; as another example, the stopper 41 of the first stopper 40 is a tapered cylindrical structure, and the stopper 41 of the second stopper 50 is a straight cylindrical structure; another example is that the stopper 41 of the first stopper 40 is The structure is straight, and the stop portion 41 of the second stopper 50 is in the shape of a cone.
  • the stopping portion 41 of the first stopper 40 is a tapered cylindrical structure
  • the fixing portion 42 is mainly used for connecting with the inner The pipe 20 is fixed, therefore, the outer diameter of the fixed part 42 is often set smaller.
  • the first stopper 40 is only provided with the first fluid channel 44, and the first fluid channel 44 is connected from the stopper part 41
  • the first fluid channel 44 makes it easier for the inflation medium to quickly enter the space between the inner wall of the tapered cylindrical structure and the inner tube 20, and then quickly reach the inflatable balloon 30 for each area.
  • the stop portion 41 of the first stopper 40 has a straight cylindrical structure
  • the first stopper 40 can be provided with a first fluid channel 44 or a second fluid channel 45 .
  • the annular structure includes a plurality of protruding structures 411 arranged along the circumferential direction, and two adjacent protruding structures
  • the recessed area between 411 forms a recessed structure 412
  • the recessed structure 412 penetrates the entire stopper 41 in the axial direction, which can be penetrated in a direction parallel to the axial direction (such as when the stopper 41 is a straight cylindrical structure), or it can be Penetrating along the oblique and axial directions (such as in the case of a tapered cylindrical structure)
  • the protruding structure 411 is formed by the inner ring surface and the outer ring surface of the annular structure protruding away from the inner tube 20 at the same time
  • the concave structure 412 is formed by The inner ring surface and the outer ring surface of the annular structure are sunken toward the direction close to the inner pipe 20 at the same time, as shown in FIG.
  • the outer contour of the fixing portion 42 is located inside the contour formed by the valley bottom of the concave structure 412, that is to say, the fixing portion 42 will not exceed
  • the outer contour of the connecting portion 43 is also located inside the contour formed by the valley bottom of the concave structure 412 .
  • the dimensions of the peaks of the protruding structure 411 from everywhere in the axial direction to the axis of the stopper 41 are equal, that is to say, the straight line formed by the crests of the protruding structure 411 (or Line segment) or the tangent plane is parallel to the axis of the stopper 41.
  • the dimensions of the troughs of the concave structure 412 along the axial direction to the axis of the stopper 41 are equal, that is to say, the troughs of the concave structure 412 form The straight line (or line segment) or the tangent plane is parallel to the axis of the stopper 41 .
  • cross-section of the straight pipe section 413 is not a circular ring
  • cross-section of the tapered pipe section 414 is not a circular ring either, and both have convex structures 411 and concave structures 412 in the circumferential direction.
  • the stopper 41 by setting the cross-section of the stopper 41 into the wave-like structure with the raised structure 411 and the concave structure 412, on the one hand, the stopper 41 has a certain radial elastic force, which can realize radial compression. , and the protruding structures 411 and the concave structures 412 are connected to each other in the circumferential direction, so that the stopper 41 affects each other no matter in the compression process, the compressed state or the free state, and restricts each other to a certain extent, avoiding the single protruding structure 411 Or the concave structure 412 freely shakes at a large angle. In this way, the stopper 41 can maintain a stable structure when it is not subjected to a large external force.
  • the protruding structure 411 can be an inverted V-shaped structure, a semi-circular ring structure, an arc-shaped ring structure, an n-shaped structure, etc.
  • the concave structure 412 can be a V-shaped groove, a semicircular groove, an arc-shaped groove, or a U-shaped groove. etc., and the shapes of the protruding structure 411 and the concave structure 412 can be combined freely.
  • Protruding structures 411 are formed on adjacent sidewalls, so that the protruding structures 411 are approximately triangular in shape.
  • the included angle of the protruding structure 411 at the crest and the included angle of the V-shaped groove at the bottom of the groove can be equal or unequal.
  • the former is smaller than the latter, that is, the angle at which the two sides of the V-shaped groove diverge is wider. large, and the angle formed by the adjacent two side walls of two adjacent V-shaped grooves is relatively small, so that when the stopper 41 is subjected to radial extrusion force, the concave structure 412 can be the structure of the convex structure 411.
  • the protruding structure 411 When the protruding structure 411 is sharp at the crest, the inflatable balloon 30 may be scratched or even ruptured during the insertion of the inner tube 20 and during the installation of the artificial valve or stent.
  • the protruding structure 411 has an arc-shaped structure at the crest.
  • the groove bottom of the V-shaped groove can also be set in an arc structure or other smooth transition structures.
  • the concave structure 412 may also be arranged in an arc structure or other smooth transition structure at the trough.
  • the stopper 41 includes a protruding structure 411
  • the first fluid channel 44 can be located at the protruding structure 411 or at the recessed structure 412, preferably the former, as shown in Fig. 5 and Fig. 3 .
  • the stopper 41 adopts, in the axial direction of the inner tube 20, the projections of the two end walls of the two artificial valves or stents are respectively and the ends of the adjacent stoppers 41 The projections of the projections at least have an overlapping area.
  • connection between the fixed part 42 and the inner tube 20 can be a plug-in connection.
  • the fixed part 42 is provided with a radially through process hole 421, that is, the process hole 421 penetrates from the outer wall of the fixed part 42.
  • the fixing part 42 and the inner tube 20 can be bonded and fixed by dispensing glue to the process hole , improve the reliability of the connection between the stopper and the inner tube 20 .

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Abstract

一种人工瓣膜的输送系统、挡件以及介入式输送装置，包括外管（10）、内管（20）、可膨胀球囊（30）、第一挡件（40）和第二挡件（50），第一挡件（40）和第二挡件（50）均包括固定部（42）和止动部（41），止动部（41）呈周向封闭的环状结构，固定部（42）与内管（20）连接，第一挡件（40）的侧壁设置有第一流体通道（44）或者第二流体通道（45）；第二挡件（50）的侧壁设置有第一流体通道（44）；第一流体通道（44）在内管（20）的轴向上贯通止动部（41）；第二流体通道（45）在内管（20）的轴向上从第一挡件（40）的止动部（41）远离固定部（42）的一端贯通至其固定部（42）远离止动部（41）的一端；两个止动部（41）的端部能够对人工瓣膜实现轴向限位。能够在可膨胀球囊（30）膨胀初期使膨胀介质流动更顺畅，有利于介入式治疗的快速进行，以及更好地防止人工瓣膜在可膨胀球囊（30）膨胀过程中发生轴向位移。

Description

人工瓣膜的输送系统、挡件及介入式输送装置
相关申请的交叉引用
本申请要求2021年09月16日提交的申请号为202111087123.X(发明名称：人工瓣膜的输送系统)的专利和2021年09月18日提交的申请号为202122253298.5(发明名称：用于介入式医疗设备的挡件及介入式输送装置)的专利的优先权。
技术领域
本申请涉及医疗器械技术领域，尤其涉及一种人工瓣膜的输送系统、挡件及介入式输送装置。
背景技术
心脏是人体的重要器官，为人体血液循环提供动力，心脏内部的瓣膜控制着血流方向，在保证通过心血管系统的充足供血流动方面发挥着至关重要的作用。当自体瓣膜发生损坏时，会导致严重的心血管损害甚至导致死亡，而人工心脏瓣膜可用于治疗心脏瓣膜疾病。目前，经导管介入式人工心脏瓣膜植入体内的过程通常都是依靠导管介入式输送系统将人工心脏瓣膜输送到预定部位进行释放。
现有技术中的输送系统包括外管、穿过外管远端的内管、位于内管远端部分的可膨胀球囊。为了防止人工瓣膜在输送过程中在可膨胀球囊上发生移位，内管上固定有两个挡件，这两个挡件位于可膨胀球囊内，可膨胀球囊的一端固定于外管的远端，另一端固定于内管的远端的挡件外壁。当输送系统输送时，可膨胀球囊处于收缩状态，压缩状态的人工瓣膜安装于可膨胀球囊的外周，且位于两个挡件之间。
上述输送系统，两个挡件在相对的部分上直径需要大于处于压缩状态的人工瓣膜的内径，因此，两个挡件的径向尺寸比较大，当输送系统携带人工瓣膜到达治疗位置时，膨胀介质流入可膨胀球囊的近端区域，进而流向中间区域和远端区域。然而，现有的这种挡件结构，当可膨胀球囊处于压缩状态时，其外周壁与两个挡件之间的间隙太小，使膨胀介质只能先将可膨胀球囊的近端区域充胀得比较大时，才能增加挡件与可膨胀球囊之间的间隙，从而使膨胀介质流动到可膨胀球囊的中间区域与远端区域，显然，可膨胀球囊各处的膨胀间隔时间太长，影响整个介入式治疗的时间；且各处间隔时间较大的膨胀方式可能导致人工瓣膜在可膨胀球囊的膨胀过程中，由于有的区域尤其是近端区域可能膨胀至使人工瓣膜的内壁位于挡件的外周，而远端区域还未开始膨胀或者膨胀介质还未到达，此时，人工瓣膜的近端不受挡件的轴向阻挡，可能会随着可膨胀球囊的近端区域的膨胀相对于发生内管轴向倾斜，造成人工瓣膜可能发生轴向位移，影响人工瓣膜放置的精确位置，降低手术质量和成功率。
发明内容
基于上述现状，本申请的主要目的在于提供一种人工瓣膜的输送系统、挡件及介入式输送装置，以解决现有技术中膨胀介质流动太慢的问题。
为实现上述目的，本申请采用的技术方案如下：
本申请提供了一种人工瓣膜的输送系统，包括外管、穿设于所述外管内部并从所述外管远端伸出的内管、可膨胀球囊、位于所述可膨胀球囊内且固定于所述内管的第一挡件和第二挡件，所述可膨胀球囊的一端安装于所述外管的远端区域，另一端安装于所述内管的远端区域；所述第一挡件较所述第二挡件靠近所述外管的远端；
所述第一挡件与所述外管之间留有间隙；所述第一挡件和所述第二挡件均包括轴向布置的固定部和止动部，所述固定部呈圆柱管状结构，与所述内管插装连接；所述止动部位于所述第一挡件和所述第二挡件相靠近的区段，且呈周向封闭的环状结构，所述止动部至少其端部的外边缘到所述固定部的轴线的最大径向尺寸大于所述固定部的半径；
所述第一挡件的侧壁设置有第一流体通道或者第二流体通道；所述第二挡件的侧壁设置有第一流体通道；其中，所述第一流体通道在所述内管的轴向上贯通所述止动部；所述第二流体通道在所述内管的轴向上从第一挡件的一端贯通至另一端；
可膨胀球囊处于收缩状态时，其上位于两个所述止动部之间的部分与两个所述止动部围成人工瓣膜的容置空间，以使处于压缩状态的人工瓣膜位于所述容置空间时两个所述止动部的端部对所述人工瓣膜实现轴向限位。
优选地，所述第一挡件设置有第一流体通道；所述止动部呈锥形筒状结构，所述止动部的小端与所述固定部连接；所述第一流体通道从所述止动部的内壁面贯通至外壁面。
优选地，所述第一流体通道的轴线与所述内管的轴线平行，或者所述第一流体通道位于所述内壁面的一端较另一端远离所述内管。
优选地，所述第一流体通道的轴线与所述内管的轴线之间的夹角为0°～30°。
优选地，所述止动部呈直筒状结构，所述止动部的侧壁的延伸方向平行于所述止动部的轴线，且所述止动部的内壁面与所述内管之间留有间隙；所述第一流体通道自所述止动部上远离所述固定部的一个端面贯通至其另一个端面。
优选地，所述第一挡件和所述第二挡件中至少一者还包括呈圆锥管状的连接部，所述连接部的大径端与所述止动部连接，小径端与所述固定部连接。
优选地，所述第一挡件和所述第二挡件沿各自的周向设置有多个流体通道。
优选地，所述环状结构包括沿周向设置的多个凸起结构，相邻的两个凸起结构之间的凹陷区形成凹陷结构，所述凸起结构由所述环状结构的内环面和外环面同时向所述环状结构的外侧凸起形成，所述凹陷结构由所述环状结构的内环面和外环面同时向靠近所述环状结构的内部凹陷形成。
优选地，所述第一流体通道设置于所述凸起结构；所述第二流体通道部分设置于所述凹陷结构。
优选地，各所述凹陷结构呈V型槽，相邻的两个V型槽的相邻槽壁形成所述凸起结构，且所述凸起结构的波峰处的夹角小于所述凹陷结构在波谷处的夹角。
本申请还提供了一种用于介入式输送装置的挡件，所述介入式输送装置用于将人工瓣膜或支架输送至患者体内，包括外管、穿过所述外管远端的内管、可膨胀球囊、位于所述可膨胀球囊内且间隔固定于所述内管的两个挡件，所述可膨胀球囊上位于两个所述挡件之 间的部分与两个所述挡件围成容置处于收缩状态的人工瓣膜或支架的容置空间；
所述挡件包括用于与所述内管插装连接的固定部和用于对所述人工瓣膜或支架限位的止动部，所述止动部呈周向封闭的环状结构，所述止动部至少其端部的外边缘到所述固定部的轴线的最大径向尺寸大于所述固定部的半径；
所述挡件的侧壁设置有流体通道，所述流体通道至少位于所述止动部，在所述固定部的轴向上所述流体通道贯通所述止动部或者从所述止动部远离所述固定部的一端贯通至所述固定部远离所述止动部的一端。
优选地，所述止动部呈直筒状结构，所述流体通道与所述固定部的轴线不垂直。
优选地，所述流体通道包括位于所述止动部的第一流体通道，所述第一流体通道自所述止动部上远离所述固定部的一个端面贯通至另一个端面。
优选地，所述流体通道包括贯通所述止动部和所述固定部的第二流体通道，所述第二流体通道的轴线相对于所述固定部的轴线倾斜设置，且位于所述止动部的一端较另一端远离所述固定部的轴线。
优选地，所述挡件还包括呈圆锥管状的连接部，所述连接部的大径端与所述止动部连接，小径端与所述固定部连接。
优选地，所述止动部呈锥形筒状结构，所述止动部的小端与所述固定部连接；所述流体通道包括位于所述止动部的第一流体通道，所述第一流体通道从所述止动部的内壁面贯通至外壁面。
优选地，所述第一流体通道的轴线与所述固定部的轴线平行；或者所述第一流体通道的轴线相对于所述固定部的轴线倾斜设置，且其位于所述内壁面的一端较另一端远离所述固定部的轴线。
优选地，所述挡件沿周向设置有多个所述流体通道。
优选地，所述环状结构包括沿周向设置的多个凸起结构，相邻的两个所述凸起结构之间的凹陷区形成凹陷结构，所述凸起结构由所述环状结构的内环面和外环面同时向远离所述固定部的轴线的方向凸起形成，所述凹陷结构由所述环状结构的内环面和外环面同时向靠近所述固定部的轴线的方向凹陷形成。
本申请还提供了一种介入式输送装置，用于将人工瓣膜或支架输送至患者体内；包括如上任一项所述的挡件。
【有益效果】
本申请的输送系统，第一挡件和第二挡件的止动部在周向上呈封闭结构，通过设置第一流体通道和第二流体通道，当膨胀介质由内管与外管之间的环形腔体流出后，不仅可以通过可膨胀球囊与第一挡件、第二挡件外周面之间的间隙从可膨胀球囊的近端区域流向中间、以及远端区域，而且，膨胀介质可以经第一挡件上的第一流体通道或者第二流体通道流入可膨胀球囊的中间区域，进而通过第二挡件上的第一流体通道流入可膨胀球囊的远端区域，由于由第一流体通道、第二流体通道形成的介质流道始终处于连通状态，因此，可膨胀球囊的中间区域尤其是远端区域不需要等待近端区域膨胀到足够大时才能够实现介质地顺畅流通，也就是说，膨胀介质基本能够同时到达可膨胀球囊的近端区域、中间区域以及远端区域，缩短了可膨胀球囊的膨胀时间，有利于介入式治疗的快速进行；且采用本申请的这种输送系统，可膨胀球囊各区域基本能够同时进行逐渐膨胀，因此，人工瓣膜的各 处会随着可膨胀球囊的逐渐膨胀呈相同程度的展开，不会造成人工瓣膜发生倾斜，从而能够尽可能避免人工瓣膜在可膨胀球囊膨胀过程中发生轴向位移，进而提高人工瓣膜在患者体内的放置位置精度，增加手术质量和成功率；同时，由于在第一挡件和第二挡件的侧壁上设置流体通道可能会降低止动部的强度，在传输过程中人工瓣膜的端面可能会与止动部发生抵压，造成止动部变形，导致人工瓣膜在输送过程中发生位移，而本申请通过将止动部设置成周向封闭的环状结构，提高了止动部的强度，能够尽可能避免输送过程中人工瓣膜发生轴向位移。
本申请的其他有益效果，将在具体实施方式中通过具体技术特征和技术方案的介绍来阐述，本领域技术人员通过这些技术特征和技术方案的介绍，应能理解所述技术特征和技术方案带来的有益技术效果。
附图说明
以下将参照附图对本申请的人工瓣膜的输送系统的优选实施方式进行描述。图中：
图1为本申请的输送系统的一种优选实施方式的结构示意图；
图2为本申请的输送系统的一种优选实施方式的局部剖视图；
图3本申请的输送系统中，第一挡件、第二挡件的一种优选实施方式的结构示意图；
图4为图3所示实施例的纵截面示意图；
图5本申请的输送系统中，第一挡件、第二挡件的另一种优选实施方式的结构示意图；
图6为图5所示实施例的纵截面示意图；
图7本申请的输送系统中，第一挡件、第二挡件的又一种优选实施方式的结构示意图；
图8为图7所示实施例的纵截面示意图；
图9本申请的输送系统中，第一挡件、第二挡件的又一种优选实施方式的结构示意图；
图10为图9所示实施例的纵截面示意图；
图11为本申请的输送系统中，止动部的一种优选实施方式的横截面示意图。
图中，
10、外管；
20、内管；
30、可膨胀球囊；
40、第一挡件；41、止动部；411、凸起结构；412、凹陷结构；42、固定部；421、工艺孔；43、连接部；44、第一流体通道；45、第二流体通道；
50、第二挡件；
60、引导件；
70、操作手柄；
80、可调弯连接管；
90、三通管。
具体实施方式
以下基于实施例对本申请进行描述，但是本申请并不仅仅限于这些实施例。在下文对 本申请的细节描述中，详尽描述了一些特定的细节部分，为了避免混淆本申请的实质，公知的方法、过程、流程、元件并没有详细叙述。
此外，本领域普通技术人员应当理解，在此提供的附图都是为了说明的目的，并且附图不一定是按比例绘制的。
除非上下文明确要求，否则整个说明书和权利要求书中的“包括”、“包含”等类似词语应当解释为包含的含义而不是排他或穷举的含义；也就是说，是“包括但不限于”的含义。
在本申请的描述中，需要理解的是，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性。此外，在本申请的描述中，除非另有说明，“多个”的含义是两个或两个以上。
需要说明的是，本申请的描述中，远端和近端是相对于输送系统的操作者而言的，近端指靠近操作者近处的一端，远端指远离操作者的一端，即对同一部件来说，若其仅部分伸入患者体内，则伸入患者体内的一端为远端，位于体外靠近操作者的一端为近端。
实施例1
本申请提供了一种人工瓣膜的输送系统，用于将人工瓣膜或者人工支架等人工器官或者支架输送至患者治疗位置。如图1-图11所示，输送系统包括外管10、设于所述外管内部并从外管10远端伸出的内管20、可膨胀球囊30、位于可膨胀球囊30内且固定于内管20的第一挡件40和第二挡件50，可膨胀球囊30的一端安装于外管10的远端区域，可以通过粘接、焊接等方式连接，另一端安装于内管20的远端区域；第一挡件40较第二挡件50靠近外管10的远端，具体地，内管20插装于外管10内，且二者之间形成有环形腔体，可供膨胀介质流过，内管20伸出外管10的远端，第一挡件40和第二挡件50安装于内管20伸出外管10的区域。
第一挡件40与外管10之间留有间隙，也就是说，第一挡件40的近端与外管10的端面不接触，如此，环形腔体内的膨胀介质可以从外管10与第一挡件40之间的间隙流出。第一挡件40和第二挡件50均包括轴向布置的固定部42和止动部41，固定部42与内管20连接，具体地，固定部42呈圆柱管状结构，与内管20插装连接。止动部41位于第一挡件40和第二挡件50相靠近的区段，也就是说，在轴向上，对于第一挡件40来说，其止动部41较其固定部42更靠近第二挡件50，对于第二挡件50来说，其止动部41较其固定部42靠近第一挡件40。其中，各止动部41呈周向封闭的环状结构，也就是说，在周向上环状结构的环带是是连续的，如图11所示。其中，止动部41上至少其端部的外边缘到固定部42的轴线的最大径向尺寸大于固定部42的半径，沿固定部42的轴向投影中，止动部41至少其端部的投影轮廓位于固定部42的投影轮廓外。其中，第一挡件40的侧壁设置有第一流体通道44或者第二流体通道45，第二挡件50的侧壁设置有第一流体通道44，第一流体通道44和第二流体通道45形成可膨胀介质流动的介质流道。具体地，第一流体通道44在内管20的轴向上贯通止动部41，第二流体通道45在内管20的轴向上贯通整个第一挡件40，从第一挡件40的一端贯通至另一端，即从第一挡件40上止动部41远离固定部42的一端贯通至其固定部42远离止动部41的一端，也就是说，第一流体通道44仅位于止动部41，且轴向贯通止动部41；第二流体通道45部分位于止动部41，部分位于固定部42，当包括有连接部43(下文详述)时，还位于连接部43，即第二流体通道45是设置于整个 第一挡件40上。如图1所示，第二挡件50仅在其止动部41上设置介质流道，第一挡件40可以仅在止动部41上设置介质流道，也可以在止动部41和固定部上均设置介质流道。
可膨胀球囊30处于收缩状态时，其上位于两个止动部41之间的部分与两个止动部41围成人工瓣膜的容置空间，以使处于压缩状态的人工瓣膜位于容置空间时两个止动部41的端部对人工瓣膜实现轴向限位。也就是说，可膨胀球囊30具有收缩状态和膨胀状态，通过对可膨胀球囊30内充入膨胀介质，可以使可膨胀球囊30至少在径向上膨胀，从而将位于其上的人工瓣膜放置于患者体内；在收缩状态时，可将人工瓣膜安装于可膨胀球囊30的外侧，此时，人工瓣膜的两个端面与两个止动部41的端面基本贴合。
上述输送系统工作时，处于压缩状态的人工瓣膜位于容置空间上，当输送系统将人工瓣膜输送至患者的治疗位置时，通入膨胀介质，膨胀介质经内管20与外管10之间的环形腔体流入第一挡件40与外管10远端的间隙流出，进入可膨胀球囊30的近端区域，经第一挡件40的第一流体通道44或者第二流体通道45进入可膨胀球囊30的中间区域，进而通过第二挡件50的第一流体通道44进入可膨胀球囊30的远端区域，当然，在这个过程中，也可能会有部分膨胀介质渗入第一挡件40、第二挡件50的外周面与可膨胀球囊30之间的间隙进而流入中间区域和远端区域。
上述输送系统，第一挡件40和第二挡件50的止动部41在周向上呈封闭结构，通过设置第一流体通道44和第二流体通道45，当膨胀介质由内管20与外管10之间的环形腔体流出后，不仅可以通过可膨胀球囊30与第一挡件40、第二挡件50之间的间隙从可膨胀球囊30的近端区域流向中间、以及远端区域，而且，膨胀介质可以经第一挡件40上的第一流体通道44或者第二流体通道45流入可膨胀球囊30的中间区域，进而通过第二挡件50上的第一流体通道44流入可膨胀球囊30的远端区域，由于由第一流体通道44、第二流体通道45形成的介质流道始终处于连通状态，因此，可膨胀球囊30的中间区域尤其是远端区域不需要等待近端区域膨胀到足够大时才能够实现介质流通，也就是说，膨胀介质基本能够同时到达可膨胀球囊30的近端区域、中间区域以及远端区域，缩短了可膨胀球囊30的膨胀时间，有利于介入式治疗的快速进行；且采用本申请的这种输送系统，可膨胀球囊30的各区域基本能够同时进行逐渐膨胀，因此，人工瓣膜各处会随着可膨胀球囊的逐渐膨胀呈相同程度的展开，也不会造成人工瓣膜发生倾斜，从而能够尽可能避免人工瓣膜在可膨胀球囊膨胀过程中发生轴向位移，进而提高人工瓣膜在患者体内的放置位置精度，增加手术质量和成功率。
可膨胀球囊30包括靠近其远端的第一区域、靠近其近端的第二区域，以及位于第一区域和第二区域的中间区域，当可膨胀球囊30膨胀时，第一区域和第二区域基本呈锥形结构，中间区域呈柱形结构，在压缩状态，人工瓣膜位于中间区域。因此，优选地，第一挡件40位于第二区域包裹的范围，第二挡件50位于第一区域包裹的范围。
在有些实施例中，为了让膨胀介质能够基本同时到达可膨胀球囊30的各个区域，将止动部41设置成多个指状结构，即固定部42同时连接有多个间隔设置的指状结构，这样，膨胀介质也能够经过两个弹性指之间的缝隙流向可膨胀球囊30的中间区域和远端区域。但是，这种结构，各指状结构相互分离，且为悬臂结构，在各个方向的自由度都很大，在运输等过程中，容易发生晃动，甚至受到振动等影响会造成变形，导致后期使用时对人工瓣膜的限位精度变差；当输送系统安装好人工瓣膜后，进入患者前或者在患者体内传输时， 多个指状结构也容易在周向和轴向上发生晃动、变形，造成人工瓣膜滑动；且这种指状结构的强度弱，在受到人工瓣膜端部的抵压时，也容易变形，影响对人工瓣膜的限位精度。而本申请中，采用周向封闭的环状结构的止动部，以及在挡件的侧壁设置的第一流体通道44和第二流体通道45，提高了止动部41的强度，既能够避免由于在第一挡件40和第二挡件50的侧壁上设置流体通道造成止动部41的强度降低，而影响在传输过程中人工瓣膜发生位移，又能够使膨胀介质尽可能同时到达可膨胀球囊30的各区域。
考虑到可膨胀球囊30的远端在膨胀过程中仍然要与内管20的远端区域连接，并不需要膨胀，且需要在此处保证密封性，因此，可膨胀球囊30的远端区域的开口常常设置的比较小，本申请的止动部41为具有径向弹性的弹性部，其可以通过结构的设置形成弹性件，也可以通过选用具有弹性性能的材料加工而成，如嵌段聚醚酰胺树脂(PEBAX)，在选用后者时，为了便于加工，可以整个第一挡件40和第二挡件50均采用这种具有弹性性能的材质制造；止动部41也可以同时通过自身的结构和材质的选择共同提高其径向可压缩的弹性能力。通过将止动部41设置成弹性部，有利于安装第一挡件40、第二挡件50的内管20从可膨胀球囊30的远端开口处安装。且在安装人工瓣膜时，为了使人工瓣膜处于更好地收缩状态，用于压缩人工瓣膜的工装夹具等可能会将止动部41一起进行径向压缩，通过本申请的这种可径向压缩的止动部41，止动部41可以随着人工瓣膜的压缩一起被压缩，不会对人工瓣膜的压缩过程造成阻碍。
其中，止动部41可以为锥形筒状结构、直筒状结构或者其他异型结构，只要端面与人工瓣膜的端面在固定部42的轴向上具有重合区域，即可实现对人工瓣膜的轴向限位。
一种优选的实施例中，止动部41呈锥形筒状结构，止动部41的侧壁沿相对于固定部42的轴线倾斜的方向延伸，也就是说，止动部41沿轴向的各处到固定部42的轴线的最大径向尺寸不同，其具有相对的内壁面和外壁面，内壁面和外壁面的延伸方向均相对于内管20的轴线倾斜设置，内壁面和外壁面的母线为直线，该直线与内管的轴线呈一非零夹角，止动部41的横截面可以为圆环面，也可以为其他异型结构，参考图3、图4所示，止动部41的小端与固定部42连接，该实施例中，止动部41的大端(即端部)的外轮廓位于固定部42的外周，可以内外壁的外轮廓均位于固定部42的外周，小端与固定部42的外周重合，采用这种结构，能够为可膨胀球囊30的近端区域与第一挡件40之间留出更多的空间，从而使膨胀介质能够更快速的进入各第一流体通道44或者第二流体通道45。
另一种实施例中，止动部41呈直筒状结构，止动部41的侧壁沿平行于固定部42的轴线的方向延伸，如图5-图10所示，止动部41沿轴向的各处到固定部42的轴线的最大径向尺寸相同，止动部41也具有内壁面和外壁面，内壁面和外壁面的延伸方向均平行于内管20的轴线，二者的母线均平行于内管20的轴线，在该实施例中，止动部41在整个轴向的各部分其外轮廓均位于固定部42的外周，为了使止动部41更容易实现径向可压缩，直筒状结构的内壁面与内管20之间留有间隙，采用这种直筒状结构，能够进一步增加止动部41在轴向上的强度，更好地提高止动部对人工瓣膜的轴向限位作用。不论止动部41呈锥形筒状结构还是直筒状结构，第一流体通道44的一个开口均可以设置在止动部41远离固定部42的端面，也可以设置于止动部41的内壁面。当止动部41呈锥形筒状结构时，第一流体通道44从止动部41的内壁面贯通至外壁面，如图3、图4所示，即第一流体通道44的一个开口设置在止动部41的内壁面，另一个开口设置在外壁面，也就是说，第一流体通 道44贯通止动部41的侧壁，其贯通方向与侧壁的厚度方向可以垂直，也可以与厚度方向呈一定的夹角，但其与止动部41的母线(包括外壁面的母线和内壁面的母线)也呈一夹角。采用这种结构，锥形筒状结构的侧壁设置的不需要太厚，这样，止动部41的径向可压缩性能更为容易，从而进一步有利于安装第一挡件40、第二挡件50的内管20与可膨胀球囊30的安装。
在止动部41呈锥形筒状结构的实施例中，优选地，第一流体通道44的管道轴线与内管20的轴线平行，如图3、图4所示；或者第一流体通道44的轴线相对于内管20的轴线倾斜设置，第一流体通道44位于内壁面的一端较另一端远离内管20，第一流体通道44位于内壁面的开口较位于外壁面的开口距离内管20远，采用这种方式，从第一挡件40的第一流体通道44射出的膨胀介质能够更快的朝向第二挡件50流动；而可膨胀球囊30的中间区域由于有人工瓣膜环绕，膨胀时需要的作用力会大于远端区域和近端区域，而采用这种倾斜设置方式的第一流体通道44，由于第一流体通道44的喷射方向朝向可膨胀球囊30的中间区域，因此，能够对该处形成一定的喷射作用，进而使该区域能够更好地膨胀。进一步地，第一流体通道44的轴线与内管20的轴线之间的夹角为0°～30°，如0°、5°、10°、15°、20°、25°、28°、30°等，从而更好地增加第一流体通道44对可膨胀球囊30的中间区域的喷射作用，更有利于可膨胀球囊30的中间区域膨胀。
当止动部41呈直筒状结构，如第一挡件40或者第二挡件50为阶梯结构时，若第一流体通道41在侧壁的厚度方向贯通止动部41的话，止动部41的外壁面与可膨胀球囊30之间的间隙比较小，不利于膨胀流体快速进入第一流体通道41，本申请的一种优选实施例中，第一流体通道44自止动部41上远离固定部42的一个端面贯通至另一个端面，第一流体通道44的一端的开口位于止动部41远离固定部42的端面，另一端的开口位于阶梯结构的阶梯面上，如此，当可膨胀介质流动至固定部42的外周时能够很快地进入到第一流体通道44。具体地，第一流体通道44的轴线与内管20的轴线可以平行，也就是说，第一流体通道44沿着平行于外壁面的母线方向(或者内壁面的母线方向)延伸，即第一流体通道44的轴线平行于内管20的轴线；也可以第一流体通道44的轴线与内管20的轴线呈一定的夹角，即第一流体通道44的轴线相对于固定部42的轴线倾斜设置，优选后者，且第一流体通道44位于止动部41远离固定部42的一端较另一端远离内管20，如图6所示，如此，既不会增加由于设置第一流体通道44而使止动部41的侧壁厚度太大，又能够使膨胀介质更快地进入第一流体通道44，且对可膨胀球囊30的中间区域形成喷射作用，从而克服人工瓣膜对中间区域膨胀的约束力，使该区域更易于膨胀。当然，第一流体通道44也可以设置成位于止动部41远离固定部42的一端较另一端靠近内管20。
在止动部41呈直筒状结构时，第一挡件40也可以设置有第二流体通道45，若第一挡件40设置有第二流体通道45，则第二流体通道45自止动部41上远离固定部42的端面贯通至固定部42上远离止动部41的端面，如图8、图10所示。在该实施例中，第二流体通道45的轴线与固定部42的轴线可以平行，优选地，第二流体通道45的轴线相对于固定部42的轴线倾斜设置，且位于止动部41的一端较另一端远离固定部42的轴线，即第二流体通道45位于止动部41的开口较另一个开口在径向上距离内管20远，如此，从第一挡件40的第二流体通道45射出的膨胀介质能够对可膨胀球囊30的中间区域(即安装有人工瓣膜的区域)形成一定的喷射作用，该喷射作用力也能够克服人工瓣膜的压缩作用力，进而 使该区域能够更好地膨胀。
需要说明的是，第一挡件40和第二挡件50各自的止动部41的结构可以相同，也可以不同，如二者的止动部41可以均呈锥形筒状结构或者直筒状结构；又如，第一挡件40的止动部41呈锥形筒状结构，第二挡件50的止动部41呈直筒状结构；又如第一挡件40的止动部41呈直筒状结构，第二挡件50的止动部41呈锥形筒状结构。但是，当第一挡件40的止动部41为锥形筒状结构时，由于止动部41的横截面在向靠近固定部42的方向逐渐减小，而固定部42主要用于与内管20固定，因此，固定部42的外径往往设置的较小，一种优选的实施例中，第一挡件40仅设置第一流体通道41，且第一流体通道41从止动部41的内壁面贯通至外壁面，采用这种结构，第一流体通道44更容易使膨胀介质快速进入到锥形筒状结构的内壁面与内管20之间的空间，进而快速到达可膨胀球囊30的各区域。当第一挡件40的止动部41呈直筒状结构时，第一挡件40可以设置第一流体通道44或者第二流体通道45。
当止动部41直筒状结构时，由于止动部41需要对人工瓣膜起到轴向限位作用，因此其外径设置的比较大，而固定部42仅需要与内管20固定连接即可，其外径设置的可以比较小，这样从一个较大的径向尺寸直接转变为一个较小的径向尺寸，容易造成第一挡件40或者第二挡件50发生断裂。为了尽可能避免上述问题的发生，本申请的一种优选实施例中，第一挡件40和第二挡件50中，至少一者还包括连接于其止动部41与固定部42之间的连接部43，如图9、图10所示，可以仅第一挡件40包括相互连接的止动部41、连接部43和固定部42，而第二挡件50包括相互连接的止动部41和固定部42；或者仅第二挡件50包括相互连接的止动部41、连接部43和固定部42，而第一挡件40包括相互连接的止动部41和固定部42；也可以二者均包括相互连接的止动部41、连接部43和固定部42。通过增加连接部43，对止动部41和固定部42起到过渡作用，能够提高第一挡件40或者第二挡件50的抗断裂强度，提高整个传输系统的可靠性。
具体地，连接部43可以为圆管状结构，即其横截面为环形，此时，圆管状结构的外径的一半小于止动部41与内管20的轴线的最大径向距离，且大于固定部42的外径的一半；圆管状结构的内壁面与内管20之间可以留有间隙，也可以直接贴合，为了便于装配，连接部43与内管20之间留有间隙，即第一挡件40和第二挡件50中仅固定部42与内管20接触连接。在另一实施例中，如图9、图10所示，连接部43呈圆锥管状结构，连接部43的横截面呈圆环状，内外环分别为圆形，连接部43的大径端与止动部41连接，小径端与固定部42连接，也就是说，连接部43的外壁面呈圆锥面，内壁面也呈圆锥面，将连接部43设置成圆锥管状结构，既能够很好地实现止动部41与固定部42的过渡，且在患者体内传输时能够减小对血管壁的损伤。当然，连接部43也可以成棱锥管状结构，即内壁面和外壁面均为棱锥面。
不论第一挡件40和第二挡件50采用上述哪种实施例，第一挡件40可以沿周向设置有多个第一流体通道44或者第二流体通道45；第二挡件50沿周向可以设置有多个第一流体通道44，以进一步使膨胀介质能够更快速地到达可膨胀球囊30在轴向上的各个区域，以及使可膨胀球囊30在周向的各处能够收到更均匀的膨胀介质施加的作用力。
其中，止动部41的横截面可以为圆环形结构，即止动部41的横截面的内环和外环均为圆形，在止动部41为直筒状结构时，其外环面和内环面均为圆柱面；在止动部41为锥 筒状结构时，其外环面和内环面均为圆锥面。为了更好地增加止动部41的径向可压缩性，本申请的一种优选实施例中，环状结构包括沿周向设置的多个凸起结构411，相邻的两个凸起结构411之间的凹陷区形成凹陷结构412，凹陷结构412沿轴向贯通整个止动部41，可以是沿平行于轴向的方向贯通(如止动部41为直筒状结构时)，也可以是沿倾斜与轴向的方向贯通(如在锥筒状结构时)，凸起结构411由环状结构的内环面和外环面同时向远离内管20的方向凸起形成，凹陷结构412由环状结构的内环面和外环面同时向靠近内管20的方向凹陷，如图11所示，止动部41的横截面呈类似波浪状的环形结构，凸起结构411和凹陷结构412间隔设置，使止动部41的整个周向上要么是凸起结构411，要么是凹陷结构412。当止动部41呈直筒状结构时，凸起结构411的波峰沿轴向的各处到止动部41的轴线(即内管20的轴线)的尺寸相等，也就是说，凸起结构411的波峰形成的直线(或者线段)或者切平面与止动部41的轴线平行；当止动部41呈锥形筒状结构时，凸起结构411的波峰形成的直线或者切平面与止动部41的轴线呈一夹角，从而使整个止动部41呈花瓣状结构。值得注意的是，在该实施例中，在沿内管20的轴向投影中，固定部42的外轮廓均位于凹陷结构412的谷底形成的轮廓内侧，也就是说，固定部42不会超出凹陷结构412，当设置有连接部43时，连接部43的外轮廓也位于凹陷结构412的谷底形成的轮廓内侧。
其中，止动部41为直筒状结构时，凸起结构411的波峰沿轴向的各处到止动部41的轴线的尺寸相等，也就是说，凸起结构411的波峰形成的直线(或者线段)或者切平面与止动部41的轴线平行，同理，凹陷结构412的波谷沿轴向的各处到止动部41的轴线的尺寸相等，也就是说，凹陷结构412的波谷形成的直线(或者线段)或者切平面与止动部41的轴线平行。当止动部41为锥筒状结构时，凸起结构411的波峰沿轴向的各处到止动部41的轴线的尺寸是渐变的，也就是说，凸起结构411的波峰形成的直线(或者线段)或者切平面与止动部41的轴线倾斜设置，同理，凹陷结构412的波谷沿轴向的各处到止动部41的轴线的尺寸是渐变的，也就是说，凹陷结构412的波谷形成的直线(或者线段)或者切平面与止动部41的轴线倾斜设置。
本申请通过将止动部41的横截面设置成上述波浪状结构，一方面，第一挡件40和第二挡件50的止动部41在周向上呈封闭结构，且设置有凸起结构411和凹陷结构412，从而使止动部41具有一定的径向弹性力，既能够实现径向压缩，且其各凸起结构411和凹陷结构412在周向上相互连接，使止动部41不论在压缩过程、压缩状态还是自由状态都相互影响，在一定程度上相互制约，避免单个凸起结构411或者凹陷结构412发生大角度的自由晃动，这样，止动部41在不受到较大外力的作用下时能够保持稳定的结构，输送系统不论在运输过程，还是进入患者前或者在患者体内传输过程中都具有更高的稳定性，因此，能够大大提高人工瓣膜在输送过程中的限位精度。
各凸起结构411的凸起方向可以为止动部41的径向，也可以与径向呈一夹角。一种优选的实施例中，止动部41的同一横截面上的各凸起结构411的波峰位于同一圆周上，各凹陷结构412的谷底位于同一圆周上，此时，各凸起结构411的波峰形成的轮廓为圆周，各凹陷结构412的谷底形成的轮廓为圆周；其中，横截面指垂直于轴向的截面，也就是说，各凸起结构411在径向上的凸起高度相等，进一步地，各凸起结构411均沿各自的径向凸起。采用这种结构，使整个止动部41在周向上各处的径向弹性力基本相等，以便于在内管20安装于可膨胀球囊30的过程以及将人工瓣膜安装于可膨胀球囊30的过程中，易于对止 动部41进行控制，且更易实现径向压缩。
凸起结构411可以为倒V型结构、半圆环结构、弧形环结构、n型结构等，凹陷结构412可以为V型槽、半圆槽、弧形槽、U型槽等，且凸起结构411与凹陷结构412的形状可以自由组合，本申请的一种优选实施例中，如图11所示，凹陷结构412呈V型槽，相邻的两个凹陷结构412的相邻侧壁形成凸起结构411，从而使凸起结构411近似呈三角结构。凸起结构411在波峰处的夹角与V型槽在槽底处的夹角可以相等，也可以不相等，优选地，前者小于或者等于后者，即V型槽的两条边岔开的角度更大，而相邻两个V型槽的相邻两个侧壁形成的夹角较小，如此，在止动部41受到径向的挤压力时，凹陷结构412能够为凸起结构411的变形提供更大的形变空间，从而使凸起结构411更容易实现径向压缩，进而有利于内管20插装于可膨胀球囊30内，以及有利于人工瓣膜安装于容置空间；且采用这种结构，相邻两个V型槽之间的槽底距离较大，使V型结构的稳定性更好，进而具有更好地限位作用。
当V型结构凸起结构411在波峰处呈尖锐状时，在内管20插装过程中以及人工瓣膜安装过程中，可能会划伤可膨胀球囊30，甚至造成破裂，优选地，凸起结构411在波峰处呈弧形结构。V型槽的槽底也可以设置成弧形结构或者其他平滑过渡的结构。凹陷结构412在波谷处也可以设置成弧形结构或者其他平滑过渡的结构。
当凹陷结构412呈V型槽时，进一步地，凸起结构411在波峰处的夹角优选为45°～90°，如45°、50°、55°、60°、65°、70°、80°、87°、90°等；V型槽的夹角优选为90°～150°，如90°、93°、98°、105°、110°、120°、130°、135°、140°、145°、150°等，采用该范围，能够更好地保证止动部41的径向可压缩性，又能够提高其轴向抗挤压能力，进而既方便内管20与可膨胀球囊的安装以及人工瓣膜安装于可膨胀球囊30上，在人工瓣膜在患者体内运输时又能够对其具有足够的轴向限位作用。
当止动部41包括凸起结构411时，第一流体通道44可以位于凸起结构411，也可以位于凹陷结构412，优选前者，如图3、图5所示，这种方式尤其适用于止动部41呈锥形筒状结构，特别其是第一挡件40的止动部41采用这种方式，由于在止动部41整体呈花瓣状结构时，膨胀介质可以通过第一挡件40的凹陷结构412流动至可膨胀球囊30的中间区域和远端区域，因此，当将第一流体通道44设置于凸起结构411时，能够在凸起结构411和凹陷结构412上均形成流体通道，进而使膨胀介质到达可膨胀球囊30的各区域的时间尽可能缩小，提高各处膨胀的一致性。当止动部41呈直筒状结构时，也可以增加止动部位于凹陷结构412内侧的壁厚，即环状结构包括位于内圈的支撑环、设置于支撑环外侧的凸起结构411和凹陷结构412，如环状结构包括径向设置的两部分，位于内侧的一部分呈圆柱筒结构(即支撑环)，位于外侧的部分包括凸起结构411和凹陷结构412，此时，第一流体通道44可以设置于支撑环。
当止动部41包括凸起结构411时，若第一挡件40设置有第二流体通道45，则优选地，第二流体通道45部分设置于凹陷结构412，如图7、图9所示，考虑到在径向上，凹陷结构412相对于凸起结构411更靠近固定部42，将第二流体通道45位于止动部41的部分设置于凹陷结构412上，能够减小止动部41的壁厚，以及使固定部42的外径设置的不需要太大。
需要说明的是，无论止动部41采用哪种结构，在内管20的轴向上，两个人工瓣膜的 两个端壁的投影分别和与其相邻的止动部41的端部的投影至少具有重合区域，若记人工瓣膜的靠近第一挡件40的端面的投影为第一投影，靠近第二挡件50的端面的投影为第二投影，第一挡件40的止动部41的端面的投影为第三投影，第二挡件50的止动部41的端面的投影为第四投影，则，第一投影与第三投影具有重合区域，第二投影与第四投影具有重合区域，如外环面的端部至少部分超出压缩状态的人工瓣膜的内壁，当外环面的端部在周向上的各部分均超出压缩状态的人工瓣膜的外壁时，内环面的端部至少部分要超出压缩状态的人工瓣膜的内壁，如此，能够防止人工瓣膜进入到止动部41的内部空间。
具体地，固定部42与内管20的连接可以为插装连接，一种优选的实施例中，固定部42设有径向贯通的工艺孔421，即工艺孔自固定部42的外壁贯通至其内壁，在第一挡件40和第二挡件50与内管20插装到位时，可以通过向工艺孔421点胶，以将固定部42与内管20粘接固定，提高第一挡件40、第二挡件50与内管20的连接可靠性。进一步地，沿固定部42的轴向，可以设置有多个工艺孔421，也可以沿固定部42的周向，设置一个、两个、或者更多个工艺孔。固定部42也可以通过热熔等方式与内管20连接。
此外，输送系统还包括引导件60，如图2所示，引导件60从远端向近端的方向，其横截面逐渐增大，具体地，引导件60可以为圆锥结构(即母线为直线)，也可以为母线为弧线的锥形结构，或者母线为双曲线或者其他曲线或者折线型的结构，以为输送系统在患者体内的传输起到引导作用。沿内管20的轴向投影，引导件60的外轮廓位于止动部41的外轮廓内。
一种实施例中，第二挡件50还包括安装部，安装部具有安装孔，引导件60部分插装于安装孔内，也就是说，安装部与引导件60插装连接，在该实施例中，内管20可以仅连接于第二挡件50的固定部42，即内管20的远端位于第二挡件50的固定部42内。
在另一种实施例中，引导件60具有轴向贯通的连接孔，内管20的远端伸出第二挡件50并与连接孔插装连接；第二挡件50的固定部42的端面与引导件60的端面接触连接，采用这种端面接触的方式，第二挡件50不需要设置专门的安装部，如此，能够降低加工难度，减少第二挡件50的长度，减小整个输送系统在远端处的轴向尺寸，且减少材料成本；再者，相对于引导件60插装于安装孔的结构，这种结构引导件60不需要刻意制作成小于安装孔的尺寸，即引导件60没必要一定设置呈阶梯轴结构，第二挡件50也不需要设置薄壁结构的安装部，直接通过端面粘接即可实现连接，进一步降低了加工难度。在该实施例中，可膨胀球囊30的远端通过第二挡件50的固定部42与引导件60中的至少一者连接于内管20的远端区域，也就是说，可膨胀球囊30的远端可以直接连接于第二挡件50的固定部42，或者直接连接于引导件60的外壁面，也可以同时连接于固定部42与引导件60的外壁面，优选地，可膨胀球囊30的远端同时连接于第二挡件50的固定部42和引导件60的外壁面，采用这种结构，能够增加可膨胀球囊30连接的可靠性，以及增加引导件60与第二挡件50连接的可靠性。进一步优选地，固定部42的外径与引导件60最大外径相等，这样，在可膨胀球囊30与固定部42、引导件60同时连接时，不会造成阶梯连接的结构，从而避免由于阶梯结构的存在影响可膨胀球囊30的密封性。
在又一实施例中，引导件60设置有连接孔；第二挡件50的固定部42远离止动部41的一端插装连接于连接孔，可膨胀球囊30的远端通过引导件60的外壁面，如图1所示，也就是说，可膨胀球囊30通过引导件60连接于内管20的远端区域，采用这种插装连接结 构，既能够减小引导件60与第二挡件50装配后的整体长度，又能够保证可膨胀球囊30在远端处的密封性。进一步地，连接孔61可以为阶梯孔，第二挡件50的固定部42插装于连接孔的大孔，在该实施例中，内管20的远端可以仅插装于第二挡件50的固定部42，也可以内管20的远端伸出第二挡件50与阶梯孔的小孔插装连接，也就是说，内管20不仅与第二挡件50的固定部42连接，同时与引导件60连接，如此，能够进一步增加第二挡件50和引导件60的连接可靠性。
需要说明的是，当引导件60与第二挡件50连接时，还能增加第二挡件50相对于内管20的轴向稳定性，从而进一步提高第二挡件50对人工瓣膜限位的可靠性。
在引导件60与固定部42形成插装连接的实施例中，二者重合的区域中，位于外侧的一者上也设置有径向贯通的工艺孔，当二者插装安装后，可以通过该工艺孔进行点胶，以实现二者的连接。
输送系统还包括显影部件，显影部件可以设置于内管20或者第一挡件40、第二挡件50上，当然，也可以设置于其他部件上，以便于操作者观察人工瓣膜在患者体内的输送情况。
继续参考图1，输送系统还包括操作手柄70、从操作手柄70的远端伸出的可调弯连接管80以及三通管90，外管10和内管20的近端处于三通管90连接，以使膨胀介质通过三通管进入外管10与内管20之间的环形腔体，远端自操作手柄70的近端延伸，并穿过可调弯连接管80的远端；操作手柄70可以对可调弯连接管80的远端部分的弯曲度进行调节，也可以调节外管10、内管20以及可膨胀球囊30相对于可调弯连接管80的相对位置，以对人工瓣膜进入患者体内的位置进行精确调节。
实施例2
本申请提供了一种介入式输送装备，包括输送系统，用于将人工瓣膜或支架等人工器官或者支架输送至患者治疗位置。如图1、图2所示，介入式输送装置包括引导件60、外管10、穿过外管10远端的内管20、可膨胀球囊30、位于可膨胀球囊30内且固定于内管20的第一挡件40和第二挡件50，引导件60连接于内管20的远端；第二挡件50较第一挡件40靠近引导件60，第一挡件40较第二挡件50靠近外管10的远端，可膨胀球囊30的一端安装于外管10的远端区域，可以通过粘接、焊接等方式连接，另一端安装于内管20的远端区域，具体可以安装于引导件和第二挡件50中的至少一者上；具体地，内管20插装于外管10内，且二者之间形成有环形腔体，可供膨胀介质流过，内管20伸出外管10的远端，第一挡件40和第二挡件50安装于内管20伸出外管10的区域。其中，第一挡件40与外管10之间留有间隙，也就是说，第一挡件40的近端与外管10的端面不接触，如此，环形腔体内的膨胀介质可以从外管10与第一挡件40之间的间隙流出。
本申请还提供了一种挡件，可以用于介入式输送装置，具体地，可以用于上述第一挡件40和第二挡件50。参考图3-图6、图8-图11，挡件包括用于与内管20插装连接的固定部42和用于对人工瓣膜或支架限位的止动部41，固定部42呈圆柱管状结构，止动部41呈周向封闭的环状结构，即在周向上边缘各处都是相互连接在一起的，不存在完全断开的区域，止动部41上至少其端部的外边缘到固定部42的轴线的最大径向尺寸大于固定部42的半径，沿固定部42的轴向投影中，止动部41至少其端部的投影轮廓位于固定部42的投影轮廓外。挡件的侧壁设置有流体通道(如第一流体通道44和第二流体通道45)，流体通 道至少位于止动部41，在固定部42的轴向上，流体通道贯通止动部41或者从止动部41远离固定部42的一端贯通至固定部42远离止动部41的一端，也就是说，流体通道可以仅位于止动部41，记该流体通道为第一流体通道44，流体通道也可以同时位于止动部41和固定部42，记该流体通道为第二流体通道45，即流体通道包括第一流体通道41和第二流体通道42，则第一流体通道44在固定部42的轴向上贯通止动部41，第二流体通道45部分位于止动部41，部分位于固定部42，当包括有连接部43(下文详述)时，还位于连接部43，即第二流体通道45是设置于整个第一挡件40上，且第二流体通道45在固定部42的轴向上贯通整个挡件，从止动部41远离固定部42的一端贯通至固定部42远离止动部41的一端。需要说明的是，这里所述的在轴向上贯通，并不限于沿轴向贯通，其也可以沿其他方向贯通，如其贯通方向可以相对于固定部42的轴向倾斜，即在下文所述的第一流体通道44与第二流体通道45的轴线均可以与固定部42的轴线倾斜设置的实施例中贯通方向与固定部42的轴向倾斜。
当第一挡件40和第二挡件50分别为上述挡件时，两个挡件相互靠近的部分为各自的止动部41，各自的固定部42与内管20插装连接，第一挡件40设置有第一流体通道44或者第二流体通道45，第二挡件50设置有第一流体通道44。也就是说，第一挡件40和第二挡件50均包括轴向连接的固定部42和止动部41，固定部42与内管20连接，具体地，与内管20插装连接。止动部41位于第一挡件40和第二挡件50相靠近的区段，在轴向上，对于第一挡件40来说，其止动部41较其固定部42更靠近第二挡件50，对于第二挡件50来说，其止动部41较其固定部42更靠近第一挡件40。其中，第一挡件40的侧壁设置有第一流体通道44或者第二流体通道45，第二挡件50的侧壁设置有第一流体通道44，第一流体通道44和第二流体通道45形成可膨胀介质流动的介质流道。如图1、图2所示，第二挡件50仅在其止动部41上设置介质流道(即设置第一流体通道44)，第一挡件40可以仅在止动部41上设置介质流道(即设置第一流体通道44)，也可以在止动部41和固定部42上均设置介质流道(即设置第二流体通道45)。
可膨胀球囊30处于收缩状态时，其上位于两个止动部41之间的部分与两个止动部41围成人工瓣膜或支架的容置空间，在处于压缩状态的人工瓣膜或支架位于容置空间时，在内管20的轴向投影中，人工瓣膜或支架的两个端面分别与相邻的止动部41的端面具有重合区域，以使处于压缩状态的人工瓣膜或支架位于容置空间时，两个止动部41的端部对人工瓣膜或支架实现轴向限位。也就是说，可膨胀球囊30具有收缩状态和膨胀状态，通过对可膨胀球囊30内充入膨胀介质，可以使可膨胀球囊30至少在径向上膨胀，从而将位于其上的人工瓣膜或支架放置于患者体内；在收缩状态时，可将人工瓣膜或支架安装于可膨胀球囊30的外侧，此时，人工瓣膜或支架的两个端面与两个止动部41的端面基本贴合。
当第一挡件40和第二挡件50使用上述挡件后，输送装置工作时，处于压缩状态的人工瓣膜或支架位于容置空间上，当输送装置将人工瓣膜或支架输送至患者的治疗位置时，通入膨胀介质，膨胀介质经内管20与外管10之间的环形腔体流入第一挡件40与外管10远端的间隙流出，进入可膨胀球囊30的近端区域，经第一挡件40的第一流体通道44或者第二流体通道45进入可膨胀球囊30的中间区域，进而通过第二挡件50的第一流体通道44进入可膨胀球囊30的远端区域，当然，在这个过程中，也可能会有部分膨胀介质流入第一挡件40、第二挡件50的外周面与可膨胀球囊30之间的间隙进而流入中间区域和远端 区域。
上述挡件，止动部41在周向上呈封闭结构，通过设置第一流体通道44和第二流体通道45，在将其安装于输送装置后，当膨胀介质由内管20与外管10之间的环形腔体流出后，不仅可以通过可膨胀球囊30与第一挡件40、第二挡件50外周壁之间的间隙从可膨胀球囊30的近端区域流向中间、以及远端区域，而且，膨胀介质可以经第一挡件40上的第一流体通道44或者第二流体通道45流入可膨胀球囊30的中间区域，进而通过第二挡件50上的第一流体通道44流入可膨胀球囊30的远端区域，由于由第一流体通道44、第二流体通道45形成的介质流道始终处于连通状态，因此，可膨胀球囊30的中间区域尤其是远端区域不需要等待近端区域膨胀到足够大时才能够实现膨胀介质流通，也就是说，膨胀介质基本能够同时到达可膨胀球囊30的近端区域、中间区域以及远端区域，缩短了可膨胀球囊30的膨胀时间，有利于介入式治疗的快速进行；且采用本申请的这种挡件和输送装置，可膨胀球囊30的各区域基本能够同时有膨胀介质流入，进行逐渐膨胀，因此，人工瓣膜或支架各处会随着可膨胀球囊的逐渐膨胀呈相同程度的展开，也不会造成人工瓣膜或支架发生倾斜，从而能够尽可能避免人工瓣膜或支架在可膨胀球囊膨胀过程中发生轴向位移，进而提高人工瓣膜或支架在患者体内放置的位置精度，增加手术质量和成功率。
其中，可膨胀球囊30包括靠近其远端的第一区域和靠近其近端的第二区域，以及位于第一区域和第二区域的中间区域，当可膨胀球囊30膨胀时，第一区域和第二区域基本呈锥形结构，中间区域呈柱形结构，在压缩状态，人工瓣膜或支架位于中间区域。因此，优选地，第一挡件40位于第二区域包裹的范围，第二挡件50位于第一区域包裹的范围。
在有些实施例中，为了让膨胀介质能够基本同时到达可膨胀球囊30的各个区域，将止动部41设置成多个弹性指状结构，即固定部42同时连接有多个间隔设置的指状结构，这样，膨胀介质也能够经过两个弹性指之间的缝隙流向可膨胀球囊30的中间区域和远端区域。但是，这种结构，各弹性指相互分离，且为悬臂结构，在各个方向的自由度都很大，在运输等过程中，容易发生晃动，甚至受到振动等影响会造成变形，导致后期使用时对人工瓣膜或支架的限位精度变差；当输送装置安装好人工瓣膜或支架后，进入患者前或者在患者体内传输时，多个指状结构也容易在周向和轴向上发生晃动，变形，造成人工瓣膜或支架滑动；且这种指状结构的强度弱，在受到人工瓣膜或支架端部的抵压时，也容易变形，影响对人工瓣膜或支架的限位精度。而本申请中，挡件采用周向封闭的环状结构的止动部，以及在挡件的侧壁设置的第一流体通道44和第二流体通道45，提高了止动部41的强度，既能够避免由于在挡件的侧壁上设置介质通道造成止动部41的强度降低，而影响在传输过程中人工瓣膜或支架发生位移，又能够使膨胀介质尽可能同时到达可膨胀球囊30的各区域。
考虑到可膨胀球囊30的远端在膨胀过程中仍然要与内管20的远端区域连接，并不需要膨胀，且需要在此处保证密封性，因此，可膨胀球囊30的远端区域的开口常常设置的比较小，本申请的止动部41为具有径向弹性的弹性部，其可以通过结构的设置形成弹性件，也可以通过选用具有弹性性能的材料加工而成，如嵌段聚醚酰胺树脂(PEBAX)，在选用后者时，为了便于加工，可以整个挡件均采用这种具有弹性性能的材质制造；止动部41也可以同时通过自身的结构和材质的选择共同提高其径向可压缩的弹性能力。通过将止动部41设置成弹性部，有利于安装有挡件的内管20从可膨胀球囊30的远端开口处安装。且在 安装人工瓣膜或支架时，为了使人工瓣膜或支架处于更好地收缩状态，用于压缩人工瓣膜或支架的工装夹具等可能会将止动部41一起进行径向压缩，通过本申请的这种可径向压缩的止动部41，止动部41可以随着人工瓣膜或支架的压缩一起被压缩，不会对人工瓣膜或支架的压缩过程造成阻碍。
其中，止动部41可以为锥形筒状结构、直筒状结构或者其他异型结构，只要其端面与人工瓣膜或支架的端面在固定部42的轴向上具有重合区域，即可实现对人工瓣膜或支架的轴向限位。
一种优选的实施例中，止动部41呈锥形筒状结构，止动部41的侧壁沿相对于固定部42的轴线倾斜的方向延伸，也就是说，止动部41沿轴向的各处到固定部42的轴线的最大径向尺寸不同，其具有相对的内壁面和外壁面，内壁面和外壁面的延伸方向均相对于内管20的轴线倾斜设置，内壁面和外壁面的母线为直线，该直线与内管的轴线呈一非零夹角，止动部41的横截面可以为圆环面，也可以为其他异型结构，参考图3、图4所示，止动部41的小端与固定部42连接，该实施例中，止动部41的大端(即端部)的外轮廓位于固定部42的外周，可以内外壁的外轮廓均位于固定部42的外周，小端与固定部42的外周重合，采用这种结构，能够为可膨胀球囊30的近端区域与第一挡件40之间留出更多的空间，从而使膨胀介质能够更快速的进入各第一流体通道44或者第二流体通道45。在止动部41呈锥形筒状结构的实施例中，挡件只设置有第一流体通道44，第一流体通道44的一个开口可以设置在止动部41远离固定部42的端面，也可以设置于止动部41的内壁面。当止动部41呈锥形筒状结构时，第一流体通道44从止动部41的内壁面贯通至外壁面，即第一流体通道44的一个开口设置在止动部41的内壁面，另一个开口设置在外壁面，也就是说，第一流体通道44贯通止动部41的侧壁，其贯通方向与侧壁的厚度方向可以垂直，也可以与厚度方向呈一定的夹角，但其与止动部41的母线(包括外壁面的母线和内壁面的母线)也呈一夹角，即不能平行于母线。采用这种结构，锥形筒状结构的侧壁设置的不需要太厚，这样，止动部41的径向可压缩性能更为容易，从而进一步有利于安装第一挡件40、第二挡件50的内管20与可膨胀球囊30的安装。
进一步优选地，第一流体通道44的管道轴线与固定部42的轴线平行，如图8所示；或者第一流体通道44相对于固定部42的轴线倾斜设置，且其位于内壁面的一端较另一端远离固定部42的轴线，即远离内轴20，第一流体通道44位于内壁面的开口较位于外壁面的开口距离内管20远，采用这种方式，从第一挡件40的第一流体通道44射出的膨胀介质能够更快的朝向第二挡件50流动；而可膨胀球囊30的中间区域由于有人工瓣膜或支架环绕，膨胀时需要的作用力会大于远端区域和近端区域，而采用这种倾斜设置方式的第一流体通道44，由于第一流体通道44的喷射方向朝向可膨胀球囊30的中间区域，因此，能够对该处形成一定的喷射作用，进而使该区域能够更好地膨胀。
另一种实施例中，止动部41呈直筒状结构，止动部41的侧壁沿平行于固定部42的轴线的方向延伸，如图5、图6、图8-图10所示，止动部41沿轴向的各处到固定部42的轴线的最大径向尺寸相同，止动部41也具有内壁面和外壁面，内壁面和外壁面的延伸方向均平行于内管20的轴线，二者的母线均平行于内管20的轴线，在该实施例中，止动部41在整个轴向的各部分其外轮廓均位于固定部42的外周，为了使止动部41更容易实现径向可压缩，直筒状结构的内壁面与内管20之间留有间隙，采用这种直筒状结构，能够进一步增 加止动部41在轴向上的强度，更好地提高止动部对人工瓣膜或支架的轴向限位作用。
当止动部41呈直筒状结构，即挡件为阶梯结构时，若第一流体通道44在侧壁的厚度方向贯通止动部41的话，止动部41的外壁面与可膨胀球囊30之间的间隙比较小，不利于膨胀流体快速进入第一流体通道44，本申请的一种优选实施例中，第一流体通道44自止动部41上远离固定部42的一个端面贯通至另一个端面，也就是说，第一流体通道44沿着外壁面的母线或者内壁面的母线延伸，其一端的开口位于止动部41远离固定部42的端面，另一端的开口位于阶梯结构的阶梯面上，如此，当膨胀介质流动至固定部42的外周时能够很快地进入到第一流体通道44。具体地，第一流体通道44的轴线与固定部42的轴线可以平行，也就是说，第一流体通道44沿着平行于外壁面的母线方向(或者内壁面的母线方向)延伸，即第一流体通道44的轴线平行于固定部42的轴线；也可以呈一定的夹角，即第一流体通道44的轴线相对于固定部42的轴线倾斜设置，优选后者，且第一流体通道44位于止动部41远离固定部42的一端较另一端远离内管20，如图6所示，如此，既不会增加由于设置第一流体通道44而使止动部41的侧壁厚度太大，又能够使膨胀介质更快地进入第一流体通道44，且对可膨胀球囊30的中间区域形成喷射作用，从而克服人工瓣膜或支架对中间区域膨胀的约束力，使该区域更易于膨胀。当然，第一流体通道44也可以设置成位于止动部41远离固定部42的一端较另一端靠近内管20。
在止动部41呈直筒状结构时，第一挡件40也可以设置有第二流体通道45，若第一挡件40设置有第二流体通道45，则第二流体通道45自止动部41上远离固定部42的端面贯通至固定部42上远离止动部41的端面，如图8、图10所示。在该实施例中，第二流体通道45的轴线与固定部42的轴线可以平行，优选地，第二流体通道45的轴线相对于固定部42的轴线倾斜设置，且位于止动部41的一端较另一端远离固定部42的轴线，即第二流体通道45位于止动部41的开口较另一个开口在径向上距离内管20远，如此，从第一挡件40的第二流体通道45射出的膨胀介质能够对可膨胀球囊30的中间区域(即安装有人工瓣膜或支架的区域)形成一定的喷射作用，该喷射作用力也能够克服人工瓣膜或支架的压缩作用力，进而使该区域能够更好地膨胀。
其中，当第一流体通道44和第二流体通道45相对于固定部42的轴线倾斜设置时，第一流体通道44的轴线、第二流体通道45的轴线各自与固定部42的轴线之间的夹角为0°～30°，如0°、5°、10°、15°、20°、25°、28°、30°等，从而更好地增加从第一流体通道44、第二流体通道45出射的膨胀介质对可膨胀球囊30的中间区域的喷射作用，更有利于可膨胀球囊30的中间区域膨胀。
在止动部41呈直筒状结构的实施例中，由于止动部41需要对人工瓣膜或支架起到轴向限位作用，因此其外径设置的比较大，而固定部42仅需要与内管20固定连接即可，其外径设置的可以比较小，这样从一个较大的径向尺寸直接转变为一个较小的径向尺寸，容易造成第一挡件40或者第二挡件50发生断裂。为了尽可能避免上述问题的发生，本申请的一种优选实施例中，第一挡件40和第二挡件50中，至少一者还包括连接于其止动部41与固定部42之间的连接部43，如图9、图10所示，可以仅第一挡件40包括相互连接的止动部41、连接部43和固定部42，而第二挡件50包括相互连接的止动部41和固定部42；或者仅第二挡件50包括相互连接的止动部41、连接部43和固定部42，而第一挡件40包括相互连接的止动部41和固定部42；也可以二者均包括相互连接的止动部41、连接部43 和固定部42。通过增加连接部43，对止动部41和固定部42起到过渡作用，能够提高第一挡件40或者第二挡件50的抗断裂强度，提高整个传输系统的可靠性。
具体地，连接部43可以为圆管状结构，即其横截面为环形，此时，圆管状结构的外径的一半小于止动部41与内管20的轴线的最大径向距离，且大于固定部42的外径的一半；圆管状结构的内壁面与内管20之间可以留有间隙，也可以直接贴合，为了便于装配，连接部43与内管20之间留有间隙，即第一挡件40和第二挡件50中仅固定部42与内管20接触连接。在另一实施例中，如图9、图10所示，连接部43呈圆锥管状结构，连接部43的横截面呈圆环状，内外环分别为圆形，连接部43的大径端与止动部41连接，小径端与固定部42连接，也就是说，连接部43的外壁面呈圆锥面，内壁面也呈圆锥面，将连接部43设置成圆锥管状结构，既能够很好地实现止动部41与固定部42的过渡，且在患者体内传输时能够减小对血管壁的损伤。当然，连接部43也可以成棱锥管状结构，即内壁面和外壁面均为棱锥面。
上述各实施例中，挡件上可以沿周向设置有多个第一流体通道44或者第二流体通道45，以进一步使膨胀介质能够更快速地到达可膨胀球囊30在轴向上的各个区域，以及使可膨胀球囊30在周向的各处能够收到更均匀的膨胀介质施加的作用力。
需要说明的是，第一挡件40和第二挡件50各自的止动部41的结构可以相同，也可以不同，如二者的止动部41可以均呈锥形筒状结构或者直筒状结构；又如，第一挡件40的止动部41呈锥形筒状结构，第二挡件50的止动部41呈直筒状结构；又如第一挡件40的止动部41呈直筒状结构，第二挡件50的止动部41呈锥形筒状结构。但是，当第一挡件40的止动部41为锥形筒状结构时，由于止动部41的横截面在向靠近固定部42的方向逐渐减小，而固定部42主要用于与内管20固定，因此，固定部42的外径往往设置的较小，一种优选的实施例中，第一挡件40仅设置第一流体通道44，且第一流体通道44从止动部41的内壁面贯通至外壁面，采用这种结构，第一流体通道44更容易使膨胀介质快速进入到锥形筒状结构的内壁面与内管20之间的空间，进而快速到达可膨胀球囊30的各区域。当第一挡件40的止动部41呈直筒状结构时，第一挡件40可以设置第一流体通道44或者第二流体通道45。
其中，止动部41的横截面可以为圆环形结构，即止动部41的横截面的内环和外环均为圆形，在止动部41为直筒状结构时，其外环面和内环面均为圆柱面；在止动部41为锥筒状结构时，其外环面和内环面均为圆锥面。为了更好地增加止动部41的径向可压缩性，本申请的一种优选实施例中，环状结构包括沿周向设置的多个凸起结构411，相邻的两个凸起结构411之间的凹陷区形成凹陷结构412，凹陷结构412沿轴向贯通整个止动部41，可以是沿平行于轴向的方向贯通(如止动部41为直筒状结构时)，也可以是沿倾斜与轴向的方向贯通(如在锥筒状结构时)，凸起结构411由环状结构的内环面和外环面同时向远离内管20的方向凸起形成，凹陷结构412由环状结构的内环面和外环面同时向靠近内管20的方向凹陷，如图11所示，止动部41的横截面呈类似波浪状的环形结构，凸起结构411和凹陷结构412在周向上连续交替设置，使止动部41的整个周向上要么是凸起结构411，要么是凹陷结构412。当止动部41呈直筒状结构时，凸起结构411的波峰沿轴向的各处到止动部41的轴线(即内管20的轴线)的尺寸相等，也就是说，凸起结构411的波峰形成的直线(或者线段)或者切平面与止动部41的轴线平行；当止动部41呈锥形筒状结构时， 凸起结构411的波峰形成的直线或者切平面与止动部41的轴线呈一夹角。值得注意的是，在该实施例中，在沿内管20的轴向投影中，固定部42的外轮廓均位于凹陷结构412的谷底形成的轮廓内侧，也就是说，固定部42不会超出凹陷结构412，当设置有连接部43时，连接部43的外轮廓也位于凹陷结构412的谷底形成的轮廓内侧。
其中，止动部41为直筒状结构时，凸起结构411的波峰沿轴向的各处到止动部41的轴线的尺寸相等，也就是说，凸起结构411的波峰形成的直线(或者线段)或者切平面与止动部41的轴线平行，同理，凹陷结构412的波谷沿轴向的各处到止动部41的轴线的尺寸相等，也就是说，凹陷结构412的波谷形成的直线(或者线段)或者切平面与止动部41的轴线平行。当止动部41为锥筒状结构时，凸起结构411的波峰沿轴向的各处到止动部41的轴线的尺寸是渐变的，也就是说，凸起结构411的波峰形成的直线(或者线段)或者切平面与止动部41的轴线倾斜设置，同理，凹陷结构412的波谷沿轴向的各处到止动部41的轴线的尺寸是渐变的，也就是说，凹陷结构412的波谷形成的直线(或者线段)或者切平面与止动部41的轴线倾斜设置。需要说明的是，直管段413的横截面并不是圆形环，锥管段414的横截面也不是圆形环的，二者在周向上都具有凸起结构411和凹陷结构412。
本申请通过将止动部41的横截面设置成上述具有凸起结构411和凹陷结构412的波浪状结构，一方面，使止动部41具有一定的径向弹性力，既能够实现径向压缩，且其各凸起结构411和凹陷结构412在周向上相互连接，使止动部41不论在压缩过程、压缩状态还是自由状态都相互影响，在一定程度上相互制约，避免单个凸起结构411或者凹陷结构412发生大角度的自由晃动，这样，止动部41在不受到较大外力的作用下时能够保持稳定的结构，输送装置不论在运输过程，还是进入患者前或者在患者体内传输过程中都具有更高的稳定性，因此，能够大大提高人工瓣膜或支架在输送过程中的限位精度；且这种结构，使膨胀介质从可膨胀球囊30的近端区域经凹陷结构412进入到中间区域和远端区域，即这种结构增加了压缩状态的可膨胀球囊30与挡件外周边缘之间的间隙，从而使膨胀介质能够更快速地进入到可膨胀球囊30的各个区域。
止动部41的同一横截面上的各凸起结构411的波峰位于同一圆周上，各凹陷结构412的谷底位于同一圆周上，此时，各凸起结构411的波峰形成的轮廓为圆周，各凹陷结构412的谷底形成的轮廓为圆周；各凸起结构411的凸起方向可以为止动部41的径向。其中，横截面指垂直于轴向的截面，也就是说，采用这种结构，使整个止动部41在周向上各处的径向弹性力基本相等，以便于在内管20安装于可膨胀球囊30的过程以及将人工瓣膜或支架安装于可膨胀球囊30的过程中，易于对止动部41进行控制，且更易实现径向压缩。
继续参考图11，凸起结构411可以为倒V型结构、半圆环结构、弧形环结构、n型结构等，凹陷结构412可以为V型槽、半圆槽、弧形槽、U型槽等，且凸起结构411与凹陷结构412的形状可以自由组合，本申请的一种优选实施例中，如图8所示，凹陷结构412呈V型槽，相邻的两个凹陷结构412的相邻侧壁形成凸起结构411，从而使凸起结构411近似呈三角结构。凸起结构411在波峰处的夹角与V型槽在槽底处的夹角可以相等，也可以不相等，优选地，前者小于后者，即V型槽的两条边岔开的角度更大，而相邻两个V型槽的相邻两个侧壁形成的夹角较小，如此，在止动部41受到径向的挤压力时，凹陷结构412能够为凸起结构411的变形提供更大的形变空间，从而使凸起结构41更容易实现径向压缩，进而有利于内管20插装于可膨胀球囊30内，以及有利于人工瓣膜或支架安装于容 置空间；且采用这种结构，相邻两个V型槽之间的槽底距离较大，使V型结构的稳定性更好，进而具有更好地限位作用。
当凸起结构411在波峰处呈尖锐状时，在内管20插装过程中以及人工瓣膜或支架安装过程中，可能会划伤可膨胀球囊30，甚至造成破裂，优选地，凸起结构411在波峰处呈弧形结构。V型槽的槽底也可以设置成弧形结构或者其他平滑过渡的结构。凹陷结构412在波谷处也可以设置成弧形结构或者其他平滑过渡的结构。当止动部41包括凸起结构411时，第一流体通道44可以位于凸起结构411，也可以位于凹陷结构412，优选前者，如图5、图3所示，这种方式尤其适用于止动部41呈锥形筒状结构，特别是第一挡件40的止动部41采用这种方式，由于在止动部41整体呈花瓣状结构时，膨胀介质可以通过第一挡件40的凹陷结构412流动至可膨胀球囊30的中间区域和远端区域，因此，当将第一流体通道44设置于凸起结构411时，能够在凸起结构411和凹陷结构412上均形成流体通道，进而使膨胀介质到达可膨胀球囊30的各区域的时间尽可能缩小，提高各处膨胀的一致性。当止动部41呈直筒状结构时，也可以增加止动部位于凹陷结构412内侧的壁厚，即环状结构包括位于内圈的支撑环、设置于支撑环外侧的凸起结构411和凹陷结构412，如环状结构包括径向设置的两部分，位于内侧的一部分呈圆柱筒结构(即支撑环)，位于外侧的部分包括凸起结构411和凹陷结构412，此时，第一流体通道44可以设置于支撑环。
当止动部41包括凸起结构411时，若第一挡件40设置有第二流体通道45，则优选地，第二流体通道45部分设置于凹陷结构412，考虑到在径向上，凹陷结构412相对于凸起结构411更靠近固定部42，将第二流体通道45位于止动部41的部分设置于凹陷结构412上，如图9所示，能够减小止动部41的壁厚，以及使固定部42的外径设置的不需要太大。
需要说明的是，无论止动部41采用哪种结构，在内管20的轴向上，两个人工瓣膜或支架的两个端壁的投影分别和与其相邻的止动部41的端部的投影至少具有重合区域，若记人工瓣膜或支架的靠近第一挡件40的端面的投影为第一投影，靠近第二挡件50的端面的投影为第二投影，第一挡件40的止动部41的端面的投影为第三投影，第二挡件50的止动部41的端面的投影为第四投影，则，第一投影与第三投影具有场合区域，第二投影与第四投影具有重合区域，如外环面的端部至少部分超出压缩状态的人工瓣膜或支架的内壁，当外环面的端部在周向上的各部分均超出压缩状态的人工瓣膜或支架的外壁时，内环面的端部至少部分要超出压缩状态的人工瓣膜或支架的内壁，如此，能够防止人工瓣膜或支架进入到止动部41的内部空间。
具体地，固定部42与内管20的连接可以为插装连接，一种优选的实施例中，固定部42设有径向贯通的工艺孔421，即工艺孔421自固定部42的外壁贯通至其内壁，在挡件(包括第一挡件40和第二挡件50)与内管20插装到位时，可以通过向工艺孔点胶，以将固定部42与内管20粘接固定，提高挡件与内管20的连接可靠性。进一步地，沿固定部42的轴向，可以设置有多个工艺孔421，也可以沿固定部42的周向，设置一个、两个、或者更多个工艺孔。固定部42也可以通过热熔等方式与内管20连接。
参考图6，引导件60从远端向近端的方向，其横截面逐渐增大，具体地，引导件60可以为圆锥结构(即母线为直线)，也可以为母线为弧线的锥形结构，或者母线为双曲线或者其他曲线或者折线型的结构，以为输送装置在患者体内的传输起到引导作用。沿内管20的轴向投影，引导件60的外轮廓位于止动部41的外轮廓内，在设有凹陷结构412时，优 选地位于凹陷结构412的外轮廓内。具体地，引导件60可以直接安装于内管20的远端，两个挡件位于引导件60与外管10的远端之间，可膨胀球囊30的远端可以套接于引导件60的外壁。引导件60也可以与第二挡件50插装连接或者端面直接接触连接，在为插装连接时，可以引导件60的近端插装于第二挡件50的固定部42内，可膨胀球囊30套接于固定部42的外壁；也可以固定部42插装于引导件60内，可膨胀球囊30套接于引导件60的外壁；在为端面接触连接时，引导件60的近端端面可以与固定部42的端面接触连接，可膨胀球囊30可以连接于引导件60，或者连接于固定部42的外壁，或者同时连接于引导件60的外壁和固定部42的外壁。不论是插装连接还是端面接触连接，内管20可以仅延伸至第二挡件50的固定部42，也可以延伸至引导件60。
当引导件60与第二挡件50连接时，还能增加第二挡件50相对于内管20的轴向稳定性，从而进一步提高第二挡件50对人工瓣膜或支架限位的可靠性。
在引导件60与固定部42形成插装连接的实施例中，二者重合的区域中，位于外侧的一者上也设置有径向贯通的工艺孔，当二者插装安装后，可以通过该工艺孔进行点胶，以实现二者的连接。
输送装置还包括显影部件，显影部件可以设置于内管20或者第一挡件40、第二挡件50上，当然，也可以设置于其他部件上，以便于操作者观察人工瓣膜或支架在患者体内的输送情况。
继续参考图5，输送系统还包括操作手柄70、从操作手柄70的远端伸出的可调弯连接管80以及三通管90，外管10和内管20的近端处于三通管90连接，以使膨胀介质通过三通管进入外管10与内管20之间的环形腔体，远端自操作手柄70的近端延伸，并穿过可调弯连接管80的远端；操作手柄70可以对可调弯连接管80的远端部分的弯曲度进行调节，也可以调节外管10、内管20以及可膨胀球囊30相对于可调弯连接管80的相对位置，以对人工瓣膜或支架进入患者体内的位置进行精确调节。
需要说明的是，本申请中第一挡件40、第二挡件50的轴线、止动部的轴线、固定部的轴线与内管20的轴线可以认为是同一轴线，上述所述的轴向也指几者同一轴线所在的方向。且虽然上述多处描述径向、径向尺寸，但是本申请并不限于该径向、径向尺寸对应的部件一定是圆柱结构、圆锥结构等，仅仅是代表在垂直于轴向的方向或者在该方向上的尺寸。
本领域的技术人员能够理解的是，在不冲突的前提下，上述各优选方案可以自由地组合、叠加。
应当理解，上述的实施方式仅是示例性的，而非限制性的，在不偏离本申请的基本原理的情况下，本领域的技术人员可以针对上述细节做出的各种明显的或等同的修改或替换，都将包含于本申请的权利要求范围内。

Claims (20)

  1. 一种人工瓣膜的输送系统，包括外管、穿设于所述外管内部并从所述外管远端伸出的内管、可膨胀球囊、位于所述可膨胀球囊内且固定于所述内管的第一挡件和第二挡件，所述可膨胀球囊的一端安装于所述外管的远端区域，另一端安装于所述内管的远端区域；所述第一挡件较所述第二挡件靠近所述外管的远端；其特征在于，
    所述第一挡件与所述外管之间留有间隙；所述第一挡件和所述第二挡件均包括轴向布置的固定部和止动部，所述固定部呈圆柱管状结构，与所述内管插装连接；所述止动部位于所述第一挡件和所述第二挡件相靠近的区段，且呈周向封闭的环状结构，所述止动部至少其端部的外边缘到所述固定部的轴线的最大径向尺寸大于所述固定部的半径；
    所述第一挡件的侧壁设置有第一流体通道或者第二流体通道；所述第二挡件的侧壁设置有第一流体通道；其中，所述第一流体通道在所述内管的轴向上贯通所述止动部；所述第二流体通道在所述内管的轴向上从第一挡件的一端贯通至另一端；
    可膨胀球囊处于收缩状态时，其上位于两个所述止动部之间的部分与两个所述止动部围成人工瓣膜的容置空间，以使处于压缩状态的人工瓣膜位于所述容置空间时两个所述止动部的端部对所述人工瓣膜实现轴向限位。
  2. 根据权利要求1所述的输送系统，其特征在于，所述第一挡件设置有第一流体通道；所述止动部呈锥形筒状结构，所述止动部的小端与所述固定部连接；所述第一流体通道从所述止动部的内壁面贯通至外壁面。
  3. 根据权利要求2所述的输送系统，其特征在于，所述第一流体通道的轴线与所述内管的轴线平行，或者所述第一流体通道位于所述内壁面的一端较另一端远离所述内管。
  4. 根据权利要求3所述的输送系统，其特征在于，所述第一流体通道的轴线与所述内管的轴线之间的夹角为0°～30°。
  5. 根据权利要求1所述的输送系统，其特征在于，所述止动部呈直筒状结构，所述止动部的侧壁的延伸方向平行于所述止动部的轴线，且所述止动部的内壁面与所述内管之间留有间隙；所述第一流体通道自所述止动部上远离所述固定部的一个端面贯通至所述止动部的另一个端面。
  6. 根据权利要求5所述的输送系统，其特征在于，所述第一挡件和所述第二挡件中至少一者还包括呈圆锥管状的连接部，所述连接部的大径端与所述止动部连接，小径端与所述固定部连接。
  7. 根据权利要求1-6任一项所述的输送系统，其特征在于，所述第一挡件和所述第二挡件沿各自的周向设置有多个流体通道。
  8. 根据权利要求1-7任一项所述的输送系统，其特征在于，所述环状结构包括沿周向设置的多个凸起结构，相邻的两个凸起结构之间的凹陷区形成凹陷结构，所述凸起结构由所述环状结构的内环面和外环面同时向所述环状结构的外侧凸起形成，所述凹陷结构由所述环状结构的内环面和外环面同时向靠近所述环状结构的内部凹陷形成。
  9. 根据权利要求8所述的输送系统，其特征在于，所述第一流体通道设置于所述凸起结构；所述第二流体通道部分设置于所述凹陷结构。
  10. 根据权利要求8所述的输送系统，其特征在于，各所述凹陷结构呈V型槽，相邻 的两个V型槽的相邻槽壁形成所述凸起结构，且所述凸起结构的波峰处的夹角小于所述凹陷结构在波谷处的夹角。
  11. 一种用于介入式输送装置的挡件，所述介入式输送装置用于将人工瓣膜或支架输送至患者体内，包括外管、穿过所述外管远端的内管、可膨胀球囊、位于所述可膨胀球囊内且间隔固定于所述内管的两个挡件，所述可膨胀球囊上位于两个所述挡件之间的部分与两个所述挡件围成容置处于收缩状态的人工瓣膜或支架的容置空间；其特征在于，
    所述挡件包括用于与所述内管插装连接的固定部和用于对所述人工瓣膜或支架限位的止动部，所述止动部呈周向封闭的环状结构，所述止动部至少其端部的外边缘到所述固定部的轴线的最大径向尺寸大于所述固定部的半径；
    所述挡件的侧壁设置有流体通道，所述流体通道至少位于所述止动部，在所述固定部的轴向上所述流体通道贯通所述止动部或者从所述止动部远离所述固定部的一端贯通至所述固定部远离所述止动部的一端。
  12. 根据权利要求11所述的挡件，其特征在于，所述止动部呈直筒状结构，所述流体通道与所述固定部的轴线不垂直。
  13. 根据权利要求12所述的挡件，其特征在于，所述流体通道包括位于所述止动部的第一流体通道，所述第一流体通道自所述止动部上远离所述固定部的一个端面贯通至另一个端面。
  14. 根据权利要求12所述的挡件，其特征在于，所述流体通道包括贯通所述止动部和所述固定部的第二流体通道，所述第二流体通道的轴线相对于所述固定部的轴线倾斜设置，且位于所述止动部的一端较另一端远离所述固定部的轴线。
  15. 根据权利要求12所述的挡件，其特征在于，所述挡件还包括呈圆锥管状的连接部，所述连接部的大径端与所述止动部连接，小径端与所述固定部连接。
  16. 根据权利要求11所述的挡件，其特征在于，所述止动部呈锥形筒状结构，所述止动部的小端与所述固定部连接；所述流体通道包括位于所述止动部的第一流体通道，所述第一流体通道从所述止动部的内壁面贯通至外壁面。
  17. 根据权利要求16所述的挡件，其特征在于，所述第一流体通道的轴线与所述固定部的轴线平行；或者所述第一流体通道的轴线相对于所述固定部的轴线倾斜设置，且其位于所述内壁面的一端较另一端远离所述固定部的轴线。
  18. 根据权利要求11-17所述的挡件，其特征在于，所述挡件沿周向设置有多个所述流体通道。
  19. 根据权利要求11-17任一项所述的挡件，其特征在于，所述环状结构包括沿周向设置的多个凸起结构，相邻的两个所述凸起结构之间的凹陷区形成凹陷结构，所述凸起结构由所述环状结构的内环面和外环面同时向远离所述固定部的轴线的方向凸起形成，所述凹陷结构由所述环状结构的内环面和外环面同时向靠近所述固定部的轴线的方向凹陷形成。
  20. 一种介入式输送装置，用于将人工瓣膜或支架输送至患者体内；其特征在于，包括权利要求11-19任一项所述的挡件。
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