WO2020124999A1 - 输送装置及输送系统 - Google Patents

输送装置及输送系统 Download PDF

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Publication number
WO2020124999A1
WO2020124999A1 PCT/CN2019/095426 CN2019095426W WO2020124999A1 WO 2020124999 A1 WO2020124999 A1 WO 2020124999A1 CN 2019095426 W CN2019095426 W CN 2019095426W WO 2020124999 A1 WO2020124999 A1 WO 2020124999A1
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WIPO (PCT)
Prior art keywords
housing
groove
circumferential groove
axial
circumferential
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PCT/CN2019/095426
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English (en)
French (fr)
Inventor
江巍
彭峰
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先健科技(深圳)有限公司
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Publication of WO2020124999A1 publication Critical patent/WO2020124999A1/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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • 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
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Definitions

  • the invention relates to the field of interventional medicine, in particular to a delivery device and delivery system.
  • the human heart is divided into four chambers, and each chamber has its own “outlet", a total of four valves (mitral valve, aortic valve, pulmonary valve and tricuspid valve), which ensure that the heart pumps Blood can flow through the cardiovascular system in a specified direction.
  • the mitral valve is located between the left atrium and the left ventricle.
  • the normal mitral valve ensures blood circulation from the left atrium to the left ventricle, and prevents blood from flowing back from the left ventricle of the heart to the left atrium.
  • the occurrence of various heart diseases or degenerative diseases may cause mitral valve dysfunction, causing the mitral valve to become abnormally narrowed or expanded. The loss of mitral valve function will affect the normal work of the heart, which will gradually weaken or endanger life.
  • mitral valve dysfunction In response to the loss of mitral valve function, there are currently a variety of treatments for mitral valve dysfunction, such as traditional valve replacement surgery, which is considered to be "open heart” surgery. In short, it is necessary to open the chest cavity during the operation, start the extracorporeal circulation with a heart-lung machine, open the heart, remove and replace the patient's diseased mitral valve, but due to the complicated operation of the extracorporeal circulation and the poor tolerance of the elderly patients, this operation There is often a higher risk of death. In recent years, the method of treating mitral valve dysfunction through intervention has gradually attracted attention, and a less invasive transcatheter technology for delivering replacement mitral valve assemblies has been developed.
  • the self-expanding prosthetic valve is generally installed in a curled state at the end of the flexible catheter and advanced through the patient's blood vessels until the prosthetic valve reaches the implantation site. Then the prosthetic valve expands to its functional size at the location of the defective natural mitral valve, replacing the diseased valve.
  • transcatheter interventional techniques to replace the natural mitral valve is an effective method for the treatment of mitral valve insufficiency
  • the release position of the artificial valve may be Unsatisfactory or released under the impact of blood flow displacement. If the valve is displaced at this time, the operation will fail due to paravalvular leakage, resulting in serious adverse consequences. Therefore, it is desirable to have a delivery device that can confirm whether the valve and the atrium wall are tightly fitted before the valve is released, thereby reducing the risk of paravalvular leakage due to inaccurate valve position or tight fitting.
  • the present invention provides a delivery device, including a catheter assembly and a control assembly, the control assembly is provided at the proximal end of the catheter assembly, the control assembly includes a first control mechanism, the first control mechanism includes a hollow housing And a limiting unit, the limiting unit includes a limiting member and a hollow receiving member, the receiving member is provided in the housing; the outer surface of the receiving member is provided with an axial groove and a circumferential groove, the A part of the limiter is received in the axial groove or the circumferential groove after passing through the housing, so that the housing can move axially or rotate in the circumferential direction, and then the housing drives and the limiter Axial movement or circumferential rotation.
  • both the axial groove and the circumferential groove are formed by the inner surface of the receiving member being radially inwardly concave, and the circumferential groove is a through groove.
  • the axial groove and the circumferential groove are arranged crosswise, and a cut is provided at the intersection.
  • the cutout is used to allow the position of the stopper to be between the axial groove and the circumferential groove Switch between slots.
  • two cutouts and second rounded corners are provided at the intersection, and the two cutouts and two second rounded corners are respectively provided on two diagonal lines at the intersection, so The distance between the two cuts is greater than the distance between the two second rounded corners.
  • the side wall of the housing is provided with a through hole, and two bosses are formed between the through hole and the outer surface of the housing;
  • the limiting member includes a rotating body, and the rotating body is interposed Between the two bosses.
  • the circumferential groove is not in communication with the axial groove;
  • the limiter includes a pressing plate and two axially spaced stoppers provided on the inner side of the pressing plate; two Among the stop bodies, one of the stop bodies is accommodated in the axial groove or the other of the stop bodies is accommodated in the circumferential groove.
  • both sides of the limiting member are connected to the housing through a rotating shaft.
  • the catheter assembly includes an inner tube that is connected to the housing and the inner tube is stationary relative to the housing.
  • the present invention also provides a delivery system, including the delivery device according to any one of the above, the delivery system further includes an implant, and the implant is detachably connected to the catheter assembly.
  • the delivery device and delivery system of the present invention by providing a first control section, directly control the connection catheter in the catheter assembly connected to the implant to quickly switch from axial movement to circumferential movement, thereby achieving accurate and reliable release position of the implant , To make the implant closely fit with the tissue and reduce the risk of paravalvular leakage.
  • FIG. 1 is a schematic diagram of the overall structure of a delivery system according to Embodiment 1 of the present invention, including a delivery device, and the delivery device includes a catheter assembly and a control assembly;
  • FIG. 2 is a schematic structural diagram of a distal portion of the delivery system shown in FIG. 1;
  • FIG. 3 is an exploded and exploded view of the structure of the first control mechanism in the control assembly shown in FIG. 1, including the containing part and the limiting part;
  • FIG. 3A is an enlarged view of a part of the structure of the control assembly shown in FIG. 3;
  • FIG. 4 is a schematic view of the structure of the receiving member in the first control mechanism shown in FIG. 3;
  • FIG. 5 is a schematic structural diagram of a stopper in the first control mechanism shown in FIG. 3;
  • 6a to 6c are schematic diagrams of the rotation of the limiting member shown in FIG. 5 at different angles;
  • FIG. 7 is an exploded exploded view of the structure of the first control mechanism in the conveying device according to the second embodiment of the present invention, including an accommodating member and a limiting member;
  • FIG. 8 is a schematic view of the structure of the stopper in the first control mechanism shown in FIG. 7;
  • 9a and 9b are schematic diagrams of a partial cross-sectional structure of the proximal end of the first control mechanism shown in FIG. 7, respectively showing states when the limiting member and the receiving member are in different positional relationships.
  • proximal end In the field of interventional medicine, the end near the operator is defined as the “proximal end”, and the end away from the operator is defined as the “distal end”.
  • the delivery device 100 of this embodiment includes a control assembly 10 and a catheter assembly 20.
  • the control assembly 10 is connected to the proximal end of the catheter assembly 20 to control the movement of the catheter assembly 20.
  • the control assembly 10 includes a first control mechanism 11, a second control mechanism 12 and a third control mechanism 13.
  • the second control mechanism 12 is disposed between the first control mechanism 11 and the third control mechanism 13
  • the first control mechanism 11 is located near the proximal end of the control assembly 10
  • the third control mechanism 13 is located near the distal end of the control assembly 10 .
  • the catheter assembly 20 includes an outer tube 21, a middle tube 22 and an inner tube 23.
  • the distal end of the inner tube 23 is provided with a screw structure for connection with the implant; the middle tube 22 is sleeved outside the inner tube 23 to facilitate recovery of the implant; the outer tube is sleeved outside the middle tube 22 and can be opposite to the middle
  • the axial movement of the tube 22 is mainly used to achieve compression and restraint of the implant. It can be understood that in other embodiments, the catheter assembly may not include a middle tube.
  • the third control mechanism 13 is connected to the outer tube 21 to control the axial movement of the outer tube 21;
  • the second control mechanism 12 is connected to the middle tube 22 to control the axial movement of the middle tube 22;
  • the control mechanism 11 is connected to the inner tube 23, and can control the axial movement and the circumferential rotation of the inner tube 23.
  • the first control mechanism 11 of this embodiment includes a hollow housing 14 and a limit unit 15.
  • the housing 14 can be formed by assembling the first housing 141 and the second housing 142, and the proximal end of the housing 14 is a solid end surface, and the inner tube 23 is connected to the proximal end of the housing through a joint 16.
  • the joint 16 is locked at the center of the proximal end surfaces of the first shell 141 and the second shell 142.
  • the connector 16 can inject liquid into the inner tube 23, such as physiological saline and contrast fluid.
  • the housing 14 is further provided with a through hole 144 that radially penetrates the side wall thereof, and a boss assembly 143 is formed between the through hole 144 and the outer surface.
  • the boss assembly 143 includes a first boss 1431 and a second boss 1432, and there is a gap between the first boss 1431 and the second boss 1432. As shown in FIG. 3A, the first boss 1431 is close to the inside of the housing 14, and the second boss 1432 is close to the outside of the housing 14.
  • the limiting unit 15 includes a limiting member 151 and a hollow receiving member 152.
  • the accommodating member 152 is provided in the casing 14, and the outer diameter of the accommodating member 152 is equal to the inner diameter of the casing 14, which ensures that the position of the accommodating member 152 in the casing 14 is stable without shaking.
  • the inner tube 23 is connected to the joint 16 after passing through the inside of the accommodating member 152. A part of the limiting member 151 passes through the casing 14 and is accommodated in the accommodating member 152.
  • the receiving member 152 has a cylindrical shape as a whole.
  • the outer surface of the receiving member 152 is provided with an axial groove 153 and a circumferential groove 154. Both grooves are formed by the outer surface of the receiving member 152 being recessed radially inward, and the two ends of the circumferential groove 154 are connected, that is, the circumferential groove 154 makes the outer surface of the receiving member 152 form a closed annular groove. Both ends of the axial groove 153 do not penetrate the end surface of the receiving member 152, so that the limiting member 151 will not detach from the axial groove 153 of the receiving member 152, ensuring that the limiting member 151 can be in the axial groove 153 Reciprocating movement.
  • the opening of the axial groove 153 is opposite to the through hole 144 on the housing 14 so that part of the stopper 151 can enter the axial groove 153 through the through hole 144.
  • the axial groove 153 and the circumferential groove 154 are arranged crosswise, and two first rounded corners 155 and two second rounded corners 156 are provided at the intersection.
  • the two first rounded corners 155 and the two second rounded corners 156 are arranged at intervals, the two first rounded corners 155 are arranged on a diagonal line at the intersection, and the two second rounded corners 156 are arranged at the other line at the intersection Diagonally.
  • the distance between the two first rounded corners 155 is greater than the distance between the two second rounded corners 156.
  • the intersection of the axial groove and the circumferential groove may be provided at other positions of the axial groove, as long as the communication between the axial groove and the circumferential groove is ensured.
  • the first rounded corner may be replaced by an incision of any shape, as long as the rotation of the limiting member can be ensured.
  • the limiting member 151 includes a first stopper 157, a rotating body 158 and a connecting body 159.
  • the connecting body 159 includes two overlapping concentric disk-shaped structures. The radius of the second disk 1592 near the outside is smaller than the radius of the second disk 1591 near the inside.
  • the first stopper 157 and the rotating body 158 are provided on opposite sides of the connecting body 159.
  • the first stopper 157 is disposed on the inner side of the connecting body 159, that is, the side near the receiving member 152; the rotating body 158 is disposed on the outer side of the connecting body 159, that is, the side away from the outer surface of the housing 14.
  • the first stop body 157 has an elongated structure, and enters the axial groove 153 through the through hole 144 on the outer surface of the housing 14. That is, the width of the first stopper 157 is not greater than the circumferential length of the axial groove 153 and the axial length of the circumferential groove 154, but the axial length is shorter than the length of the axial groove 153, which can ensure the first stop The stopper 157 can move axially in the axial groove 153. In order to ensure that the position of the first stop body 157 can be switched between the axial groove 157 and the circumferential groove 154 by rotation, the space between the two first rounded corners 155 provided at the intersection of the two grooves should be sufficient to allow the first A stop body 157 passes.
  • the through hole 144 on the casing 14 is circular, and the circular diameter is not less than the length of the first stop body 157 for the first stop body 157 to rotate. It can be understood that, in other embodiments, the through hole 144 may not match the rotation trajectory of the first stop body 157. At this time, there is enough space between the inner wall of the housing 14 and the receiving member 152 for the first The stopper 157 rotates.
  • the connecting body 159 is interposed between the two bosses 143 of the housing 14, so that the limiting member 151 can move axially or circumferentially along with the housing 14.
  • a disc 1591 is located in the gap between the two bosses 143.
  • only the first rounded corner may be provided at the intersection of the axial groove and the circumferential groove, as long as the space at the intersection can accommodate the first stop body and at the same time ensure the first stop The position of the body can be switched between the axial groove and the circumferential groove. At this time, the maximum rotation angle of the limiting member is 90 degrees. It can also be understood that, in other embodiments, the four rounded corners at the intersection may also be identical.
  • the rotating body 158 is used to manually operate the rotation limiting member 151, so that the position of the first stop body 157 is switched between the two grooves of the receiving member 152.
  • the shape of the rotating body 158 is the same as the shape of the first stop body 157, and the length extension direction of the rotating body 158 is also consistent with the length extension direction of the first stop body 157.
  • the position of the first stop body 157 can be determined by the position of the rotating body 158.
  • the length extension direction of the rotating body may also be set perpendicular to the first stop body; or, the length extension direction of the rotating body and the length extension direction of the first stop body may be at any acute angle
  • the connecting piece can be made of transparent material, which is convenient for observing the position of the first stop body; at the same time, the rotating body can also be set into other shapes that are convenient for manual operation, as long as the first stop body can be easily observed Location.
  • the limiter may not include the connecting body.
  • the width of the rotating body may be set to be larger than the width of the through hole on the housing to ensure that the limiter can be erected on the housing Just go.
  • FIG. 6a to 6c show a position diagram when the rotating body 158 drives the first stop body 157 to rotate to different angles.
  • the restricting member 151 cannot move relative to the receiving member 152 due to the restriction of the wall of the receiving member 152, so that the housing 14 cannot move relative to the receiving member 152, so Also, the inner tube 23 connected to the housing 14 cannot move relative to other parts of the delivery device 100, and this shape can be called a "locked state".
  • the first stop body 157 is received in the axial groove 153, and at this time, the limiting member 151 can be axially moved relative to the receiving member 152 by the housing 14 Movement, so that the inner tube 23 connected to the housing 14 can also move axially together, and this state can be referred to as a "pulled state".
  • the rotating body 158 is in the position shown in FIG. 6c, the first stop body 157 is received in the circumferential groove 154, and at this time, the stopper 151 can be rotated by the housing 14 relative to the receiving member 152 in the circumferential direction. Therefore, the inner tube 23 connected to the housing 14 can also rotate together in the circumferential direction, and this state can be referred to as a "release state".
  • the present invention includes a delivery system 300 of a delivery device according to Embodiment 1 and further includes an implant 200.
  • the implant in this embodiment is an artificial heart valve.
  • the implant 200 is detachably connected to the catheter assembly 20, in particular, the implant can be connected to the inner tube 23 by threads.
  • the stopper 151 should be in a "locked state" to avoid misoperation.
  • the third control mechanism 13 controls the outer tube 21 to move toward the proximal end, so that the artificial heart valve connected to the distal end of the inner tube 23 is released from the outer tube 21 from the compressed state Expansion, at this time, the artificial heart valve is still connected to the inner tube 23; then, the limiter 151 is rotated to make it in a "pulled state", and the housing 14 is moved back and forth axially, so that the inner tube 23 is moved back and forth axially to pull Pull the artificial heart valve to confirm whether the release position is accurate and reliable; finally, turn the limiter 151 to make it in the "released state", and axially rotate the casing 14 to rotate the inner tube 23 circumferentially, so that the artificial heart valve is separated from The threaded connection at the distal end of the inner tube 23 is disengaged to realize the release of the artificial heart valve.
  • the limiter is located at the intersection of the two grooves after moving along with the axial direction
  • the delivery device of the present invention controls the movement of the inner tube through the first control mechanism, allows the inner tube to move axially, and indirectly pulls the artificial heart valve by operating the first control structure to ensure the release
  • the inner tube is switched to a state that can be rotated circumferentially, and the artificial heart valve is released through the circumferential rotation to reduce the risk of paravalvular leakage.
  • the structure of the conveying device of this embodiment is basically the same as that of the conveying device 100 of the first embodiment, except for the first control mechanism 31.
  • the first control mechanism 31 of this embodiment includes a housing 34, an accommodating member 352 and a limiting member 351.
  • the structure of the housing 34 of this embodiment is basically the same as the housing 14 of the first embodiment, and will not be repeated here.
  • the receiving member 352 is provided with an axial groove 353 and a circumferential groove 354, and the circumferential groove 354 is close to the proximal end of the axial groove 353, and the two are not connected. As shown in FIG.
  • the stopper 351 includes a pressing plate 358 and a second stopper 357 and a third stopper 359 provided inside the pressing plate 358.
  • the second stopper 357 is near the distal end of the pressing plate 358
  • the third stopper 359 is near the proximal end of the pressing plate 358.
  • Rotating shafts 355 are also provided on both sides of the pressing plate 358.
  • the limiting member 351 is connected to the housing 34 through a rotating shaft 355, so that the limiting member 351 can rotate relative to the housing 34 about the rotating shaft 355.
  • the third stopper 359 can be accommodated in the circumferential groove 354 or the second stopper 357 can be accommodated in the axial groove 353, that is, the second stopper 357 and the first
  • the three stop bodies 359 cannot be in the groove at the same time.
  • FIG. 9a when the second stopper 357 is received in the axial groove 353, the housing 34 and the inner tube 43 can move axially, thereby confirming whether the prosthetic heart valve is released in an ideal position.
  • the housing 34 and the inner tube 43 can rotate in the circumferential direction, thereby releasing the artificial heart valve.
  • the circumferential groove may also be disposed near the distal end of the axial groove, in this case, the second stopper body is disposed relative to the circumferential groove, and the third stopper body is disposed relative to the axial groove Settings.
  • the operation process of the conveying device of this embodiment is substantially the same as the operation process of the conveying device 100 of the first embodiment, and only the operation mode of the first control mechanism 31 needs to be changed, that is, the rotation is changed to the form of pressing. The rest will not repeat.
  • the delivery device of the present invention is mainly used for delivering artificial heart valves. It can be understood that the design concept of the present invention can also be adopted when other medical instruments need to be stretched to determine whether the release position is accurate.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

一种输送装置（100），包括导管组件（20）和控制组件（10），控制组件（10）设于导管组件（20）近端，控制组件（10）包括第一控制机构（11），第一控制机构（11）包括中空的壳体（14）和限位单元（15），限位单元（15）包括限位件（151）和中空的收容件（152），收容件（152）设于壳体（14）内；收容件（152）的外表面设有轴向凹槽（153）和周向凹槽（154），限位件（151）部分穿过壳体（14）后收容于轴向凹槽（153）或周向凹槽（154）内，使得壳体（14）可轴向移动或周向转动，壳体（14）再带动且限位件（151）轴向移动或周向转动。该输送装置（100）及输送系统通过设置第一控制机构（11），直接控制与植入体相连的导管组件（20）中的连接导管从轴向运动快速转换至周向运动，从而实现植入体释放位置准确可靠，使植入体与组织紧密贴合，降低瓣周漏发生的风险。

Description

输送装置及输送系统 技术领域
本发明涉及介入医疗领域，具体涉及一种输送装置及输送系统。
背景技术
人体的心脏分为四个腔室，每个腔室都有各自的“出口”，共有四个瓣膜(二尖瓣、主动脉瓣、肺动脉瓣和三尖瓣)，它们确保由心脏泵送的血液能在心血管系统中按照指定的方向流过。二尖瓣位于左心房和左心室之间，正常的二尖瓣保证血液循环由左心房向左心室方向流动，且可防止血液从心脏的左心室向左心房回流。各种心脏疾病或退行性病变的发生，可能导致二尖瓣功能障碍，使得二尖瓣变得异常缩窄或扩张。二尖瓣功能的缺失损伤，会影响心脏的正常工作，致使人逐渐衰弱或危及生命。
针对二尖瓣功能的缺失，目前已有多种治疗二尖瓣功能障碍的方法，如传统的瓣膜置换手术，被认为是“开放心脏”手术。简而言之，手术时需要打开胸腔，用心肺机启动体外循环，打开心脏，切除和更换患者的病变二尖瓣，但由于体外循坏的操作复杂和老年患者的耐受性差，这种手术往往有较高的死亡风险。近年来，通过介入手段治疗二尖瓣功能障碍的方法逐渐被人们所关注，并开发了用于递送置换二尖瓣组装件的创伤较小的经导管技术。在此类技术中，自膨式假体瓣 膜一般以卷曲状态安装在柔性导管的末端并经患者的血管推进，直至该假体瓣膜抵达植入部位。继而假体瓣膜在有缺陷的天然二尖瓣膜的部位处扩张至其功能尺寸，替代病变瓣膜。
虽然经导管介入技术置换天然二尖瓣膜是治疗二尖瓣功能不全的有效方法，但由于二尖瓣复合体的解剖结构较复杂、心室收缩产生的腔内压力较大，人工瓣膜的释放位置可能不理想或在血流冲击下释放发生移位。若此时出现瓣膜移位，则会因瓣周漏导致手术失败，产生严重不良后果。因此期望能有一种输送装置，其在瓣膜解脱前还能够确认瓣膜与心房壁是否紧密贴合，从而减少因瓣膜位置不准确或贴合不紧而发生瓣周漏的风险。
发明内容
本发明提供了一种输送装置，包括导管组件和控制组件，所述控制组件设于所述导管组件近端，所述控制组件包括第一控制机构，所述第一控制机构包括中空的壳体和限位单元，所述限位单元包括限位件和中空的收容件，所述收容件设于所述壳体内；所述收容件的外表面设有轴向凹槽和周向凹槽，所述限位件部分穿过所述壳体后收容于所述轴向凹槽或周向凹槽内，使得所述壳体可轴向移动或周向转动，所述壳体再带动且所述限位件轴向移动或周向转动。
在一实施例中，所述轴向凹槽与所述周向凹槽均由所述收容件的外表面径向内凹形成，且所述周向凹槽为贯通槽。
在一实施例中，所述轴向凹槽与所述周向凹槽交叉设置，且交叉 处设有切口所述切口用于允许所述限位件的位置在所述轴向凹槽与所述周向凹槽之间转换。
在一实施例中，所述交叉处设有两个切口和第二圆角，且所述两个切口和两个第二圆角分别设于所述交叉处的两条对角线上，所述两个切口之间的距离大于所述两个第二圆角之间的距离。
在一实施例中，所述壳体侧壁设有通孔，所述通孔与所述壳体外表面之间形成两个凸台；所述限位件包括转动体，所述转动体夹设于所述两个凸台之间。
在一实施例中，所述周向凹槽与所述轴向凹槽不连通；所述限位件包括按压板和设于所述按压板内侧的两个轴向相互间隔开的止挡体；两个所述止挡体中，一个所述止挡体收容于所述轴向凹槽或另一个所述止挡体收容于所述周向凹槽。
在一实施例中，所述限位件两侧通过转轴与所述壳体相连。
在一实施例中，所述导管组件包括内管，所述内管与所述壳体相连且所述内管相对所述壳体静止。
本发明还提供了一种输送系统，包括上述的任一项所述的输送装置，所述输送系统还包括植入体，所述植入体与所述导管组件可拆卸连接。
本发明的输送装置及输送系统，通过设置第一控制部，直接控制与植入体相连的导管组件中的连接导管从轴向运动快速转换至周向运动，从而实现植入体释放位置准确可靠，使植入体与组织紧密贴合，降低瓣周漏发生的风险。
附图说明
图1为本发明实施例一的输送系统的整体结构示意图，包括输送装置，输送装置包括导管组件和控制组件；
图2为图1所示的输送系统的远端部分结构示意图；
图3为图1所示的控制组件中第一控制机构结构分解爆炸图，包括收容件和限位件；
图3A为图3所示的控制组件部分结构放大图；
图4为图3所示的第一控制机构中收容件结构示意图；
图5为图3所示的第一控制机构中限位件结构示意图；
图6a至图6c为图5所示的限位件旋转不同角度示意图；
图7为本发明实施例二的输送装置中第一控制机构结构分解爆炸图，包括收容件和限位件；
图8为图7所示的第一控制机构中限位件结构示意图；
图9a和图9b为图7所示的第一控制机构近端部分剖面结构示意图，分别示出了限位件与收容件处于不同位置关系时的状态。
具体实施方式
为了更好地理解本发明的技术方案和有益效果，以下结合附图对本发明的输送装置做举例说明。以下具体实施例仅为部分优选实施例，并非对本发明的限制。
在介入医疗领域，定义靠近操作者的一端为“近端”，远离操作者的一端为“远端”。
实施例一
如图1所示，本实施例的输送装置100包括控制组件10和导管组件20。控制组件10与导管组件20的近端相连，用以控制导管组件20的运动。控制组件10包括第一控制机构11、第二控制机构12和第三控制机构13。其中，第二控制机构12设于第一控制机构11和第三控制机构13之间，第一控制机构11靠近控制组件10的近端设置，第三控制机构13靠近控制组件10的远端设置。同时参考图2，导管组件20包括外管21、中管22和内管23。内管23远端设有螺纹结构，用以与植入体相连；中管22套设于内管23外，方便回收植入体；外管套设于中管22外，并可相对于中管22轴向运动，主要用于实现对植入体的压缩束缚。可以理解的是，在其它实施例中，导管组件可以不包括中管。再次回到图1，第三控制机构13与外管21相连，可以控制外管21的轴向移动；第二控制机构12与中管22相连，可以控制中管22的轴向移动；第一控制机构11与内管23相连，可以控制内管23的轴向移动和周向转动。
如图3所示，本实施例的第一控制机构11包括中空的壳体14和限位单元15。其中，壳体14可由第一壳体141和第二壳体142组装形成，并且壳体14近端为一实体端面，内管23通过一接头16与壳体近端相连。接头16卡设于第一壳体141和第二壳体142近端端面中心位置。通过接头16可以向内管23内注射液体，例如生理盐水和造影液等。壳体14上还设有径向贯穿其侧壁的通孔144，且通孔144 与外表面之间还形成凸台组件143。凸台组件143包括第一凸台1431及第二凸台1432，且第一凸台1431及第二凸台1432之间存在间隙。如图3A所示，第一凸台1431靠近壳体14的内侧，第二凸台1432靠近壳体14的外侧。
限位单元15包括限位件151和中空的收容件152。收容件152设于壳体14内，且收容件152外径尺寸与壳体14内径尺寸相当，保证收容件152在壳体14内位置稳定，不会产生晃动。且内管23从收容件152内部穿过后与接头16相连。限位件151的一部分穿过壳体14后收容于收容件152内。
一并参阅图3及图4，收容件152整体呈圆柱状。收容件152的外表面设有一轴向凹槽153和一周向凹槽154。两个凹槽均由收容件152的外表面径向向内凹陷形成，且周向凹槽154的两端连通，即周向凹槽154使得收容件152外表面形成一闭合的环形凹槽。轴向凹槽153的两端均未贯穿收容件152的端面，使得限位件151不会从收容件152的轴向凹槽153内脱离，保证限位件151能在轴向凹槽153内往复运动。轴向凹槽153的开口与壳体14上的通孔144相对，以使得部分限位件151可通过通孔144进入到轴向凹槽153内。轴向凹槽153与周向凹槽154交叉设置，交叉处设有两个第一圆角155和两个第二圆角156。两个第一圆角155和两个第二圆角156间隔设置，两个第一圆角155设置在交叉处的一条对角线上，两个第二圆角156设置在交叉处的另一条对角线上。其中，两个第一圆角155之间的距离大于两个第二圆角156之间的距离。因轴向凹槽与周向凹槽交叉时，交叉处 未设置圆角时包括四个尖锐转角，为防止限位件转动时，收容于凹槽内的部分磨损转角，将其中交叉相对的两个转角设置成第二圆角。可以理解的是，在其它实施例中，轴向凹槽和周向凹槽的交叉处可以设置在轴向凹槽的其它位置，只要保证轴向凹槽和周向凹槽连通即可。可以理解的是，在其它实施例中，第一圆角可以用任意形状的切口替代，只要能保证限位件转动即可。
请一并参阅图3及图5，限位件151包括第一止挡体157、转动体158以及连接体159。其中连接体159包括两个相叠的同心圆盘形结构，靠近外侧的第二圆盘1592的半径小于靠近内侧的第二圆盘1591的半径。第一止挡体157和转动体158相对设于连接体159的两侧。且第一止挡体157设于连接体159的内侧，即靠近收容件152的一侧；转动体158设于连接体159的外侧，即远离壳体14外表面的一侧。第一止挡体157为长形结构，且通过壳体14外表面上的通孔144进入到轴向凹槽153内。即第一止挡件157的宽度不大于轴向凹槽153的周向长度以及周向凹槽154的轴向长度，但其轴向长度短于轴向凹槽153的长度，这样能保证第一止挡体157可以在轴向凹槽153轴向移动。为了保证第一止挡体157的位置可以通过旋转在轴向凹槽157和周向凹槽154之间转换，两个凹槽交叉处设置的两个第一圆角155之间的空间应足够允许第一止挡体157通过。并且，壳体14上的通孔144为圆形，圆形直径不小于第一止挡体157的长度，供第一止挡体157转动。可以理解的是，在其它实施例中，通孔144也可以不与第一止挡体157的转动轨迹匹配，此时，在壳体14内壁与收容件152 之间有足够的空间供第一止挡体157转动。连接体159夹设于壳体14的两个凸台143之间，使得限位件151可以随着壳体14一起轴向运动或周向转动。其中连接体159上靠近外侧的第二圆盘1592与通孔144处靠近外侧的第二凸台1432的侧面相抵，靠近内侧的第一圆盘1591夹设于两个凸台之间，即第一圆盘1591位于两个凸台143之间的间隙内。可以理解的是，在其它实施例中，轴向凹槽和周向凹槽的交叉处也可以只设置一个第一圆角，只要交叉处的空间能容纳第一止挡体且同时保证第一止挡体的位置能在轴向凹槽和周向凹槽之间转换即可，此时，限位件的最大转动角度为90度。同样可以理解的是，在其它实施例中，交叉处的四个圆角也可以完全相同。
转动体158用于手动操作转动限位件151，从而使第一止挡体157的位置在收容件152的两个凹槽之间转换。本实施例中，转动体158的形状与第一止挡体157的形状相同，且转动体158的长度延伸方向也与第一止挡体157的长度延伸方向一致，这样，在限位件151转动过程中，通过转动体158的位置即可确定第一止挡体157所处的位置。可以理解的是，在其它实施例中，转动体的长度延伸方向也可以设置成与第一止挡体垂直；或者，转动体的长度延伸方向与第一止挡体的长度延伸方向成任意锐角，此时，可将连接件可用透明材料制成，方便观察第一止挡体所处的位置；同时，转动体也可以设置成其其它方便手动的形状，只要能方便观察第一止挡体的位置即可。
可以理解的是，在其其它实施例中，限位件也可以不包括连接体，此时可将转动体的宽度设置成大于壳体上通孔的宽度，保证限位件能 架设于壳体上即可。
图6a至图6c示出了转动体158带动第一止挡体157旋转到不同角度时的位置图。当转动体158位于图6a所示的位置时，受收容件152管壁的限制，限位件151无法相对于收容件152产生运动，从而壳体14也不能相对于收容件152产生运动，因此，与壳体14相连的内管23也不能相对于输送装置100的其它部分产生运动，可将此状体称为“锁定状态”。当转动体158位于图6b所示的位置时，第一止挡体157收容于轴向凹槽153内，此时，限位件151可在壳体14的带动下相对于收容件152轴向运动，从而，与壳体14相连的内管23也可以一起轴向运动，可将此状态称为“牵拉状态”。当转动体158位于图6c所示的位置时，第一止挡体157收容于周向凹槽154内，此时，限位件151可在壳体14的带动下相对于收容件152周向转动，从而，与壳体14相连的内管23也可以一起周向转动，可将此状态称为“释放状态”。
应当理解，本发明的重点在于第一控制机构对内管的控制，其它控制机构的具体结构将不做详细论述，本领域技术人员可根据实际需求设置其它控制机构对相应导管的控制，只要不影响第一控制机构对内管的控制即可。
再次参阅图1，本发明包含实施例一输送装置的输送系统300还包括植入体200，本实施例的植入体为人工心脏瓣膜。植入体200与导管组件20可拆卸连接，具体地，植入体可与内管23通过螺纹连接。利用本实施例的输送装置100输送人工心脏瓣膜时，应保证限位件 151处于“锁定状态”，避免误操作。将输送装置100的远端输送到指定位置之后，通过第三控制机构13控制外管21朝向近端移动，使连接在内管23远端的人工心脏瓣膜脱离外管21的束缚，从压缩状态扩张，此时，人工心脏瓣膜仍与内管23相连；接着转动限位件151，使其处于“牵拉状态”，轴向前后移动壳体14，使得内管23轴向前后移动，以牵拉人工心脏瓣膜，确认释放位置是否准确可靠；最后，转动限位件151，使其处于“释放状态”，轴向转动壳体14，使得内管23周向旋转，从而使人工心脏瓣膜从与内管23远端的螺纹连接中脱离，实现人工心脏瓣膜的释放。为方便观察限位件在随壳体轴向移动后是否位于两个凹槽的交叉处，方便转换成“释放状态”，壳体和限位件均可以采用透明材料制成。
因此，本发明的输送装置在释放人工心脏瓣膜之前，通过第一控制机构实现对内管运动的控制，允许内管轴向运动，通过操作第一控制结构，间接牵拉人工心脏瓣膜，保证释放位置准确可靠之后再使内管转换至可周向旋转的状态，通过周向旋转释放人工心脏瓣膜，降低瓣周漏发生的风险。
实施例二
本实施例的输送装置与实施例一的输送装置100结构基本一致，不同之处仅在于第一控制机构31。如图7所示，本实施例的第一控制机构31包括壳体34、收容件352和限位件351。本实施例的壳体34的结构与第一实施例的壳体14基本相同，此处不再赘述。收容件352 上设有轴向凹槽353和周向凹槽354，且周向凹槽354靠近轴向凹槽353的近端，二者不连通。如图8所示，限位件351包括按压板358和设于按压板358内侧的第二止挡体357和第三止挡体359。其中第二止挡体357靠近按压板358的远端，第三止挡体359靠近按压板358的近端。按压板358的两侧还设有转轴355。限位件351通过转轴355与壳体34相连，从而使得限位件351可相对于壳体34以转轴355为中心转动。通过按压按压板358的近端或远端可使第三止挡体359收容于周向凹槽354内或第二止挡体357收容于轴向凹槽353内，即第二止挡体357和第三止挡体359不能同时处于凹槽内。如图9a所示，当第二止挡体357收容于轴向凹槽353内时，壳体34和内管43可轴向移动，从而确认人工心脏瓣膜的释放位置是否理想。如图9b所示，当第三止挡体359收容于周向凹槽354内时，壳体34和内管43可周向转动，从而释放人工心脏瓣膜。在操作输送装置的过程中，限位件351处于类似实施例一的“锁定状态”时，需保证壳体34的运动仍受限位件351限制，即第二止挡体357和第三止挡体359均仍部分收容于凹槽内，使得限位件351既不能轴向移动也不能周向转动。因此，需保证第二止挡件357与轴向凹槽353底面相抵时，第三止挡件359才能完全从周向凹槽354中脱离，反之亦然。
可以理解的是，在其它实施例中，周向凹槽也可以靠近轴向凹槽的远端设置，此时，第二止挡体相对于周向凹槽设置，第三止挡体相对于轴向凹槽设置。
本实施例的输送装置的操作过程与实施例一的输送装置100的操 作过程大致相同，只需改变第一控制机构31的操作方式即可，即将转动换成按压的形式。其余不再赘述。
本发明的输送装置主要用于人工心脏瓣膜的输送，可以理解的是，当其它医疗器械需要通过牵拉来确定释放位置是否准确时，也可以采用本发明的设计构思。
可以理解的是，上述具体实施方式仅为部分优选实施例，并非对本发明的限制，本领域技术人员可以根据实际需求对部分结构做简单替换，在不脱离本发明构思的前提下的做的非实质性改变均在本发明保护范围之内，本发明保护范围以权利要求为准。

Claims (9)

  1. 一种输送装置，包括导管组件和控制组件，所述控制组件设于所述导管组件近端，其特征在于，所述控制组件包括第一控制机构，所述第一控制机构包括中空的壳体和限位单元，所述限位单元包括限位件和中空的收容件，所述收容件设于所述壳体内；所述收容件的外表面设有轴向凹槽和周向凹槽，所述限位件部分穿过所述壳体后收容于所述轴向凹槽或周向凹槽内，使得所述壳体可轴向移动或周向转动，所述壳体再带动且所述限位件轴向移动或周向转动。
  2. 根据权利要求1所述的输送装置，其特征在于，所述轴向凹槽与所述周向凹槽均由所述收容件的外表面径向内凹形成，且所述周向凹槽为贯通槽。
  3. 根据权利要求2所述的输送装置，其特征在于，所述轴向凹槽与所述周向凹槽交叉设置，且交叉处设有切口所述切口用于允许所述限位件的位置在所述轴向凹槽与所述周向凹槽之间转换。
  4. 根据权利要求3所述的输送装置，其特征在于，所述交叉处设有两个切口和第二圆角，且所述两个切口和两个第二圆角分别设于所述交叉处的两条对角线上，所述两个切口之间的距离大于所述两个第二圆角之间的距离。
  5. 根据权利要求3所述的输送装置，其特征在于，所述壳体侧壁设有通孔，所述通孔与所述壳体外表面之间形成两个凸台；所述限位件包括转动体，所述转动体夹设于所述两个凸台之间。
  6. 根据权利要求2所述的输送装置，其特征在于，所述周向凹槽与所述轴向凹槽不连通；所述限位件包括按压板和设于所述按压板内侧 的两个轴向相互间隔开的止挡体；两个所述止挡体中，一个所述止挡体收容于所述轴向凹槽或另一个所述止挡体收容于所述周向凹槽。
  7. 根据权利要求6所述的输送装置，其特征在于，所述限位件两侧通过转轴与所述壳体相连。
  8. 根据权利要求1至7中任一项所述的输送装置，其特征在于，所述导管组件包括内管，所述内管与所述壳体相连且所述内管相对所述壳体静止。
  9. 一种输送系统，包括如权利要求1至7中任一项所述的输送装置，其特征在于，所述输送系统还包括植入体，所述植入体与所述导管组件可拆卸连接。
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