WO2018053928A1 - 人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统 - Google Patents

人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统 Download PDF

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Publication number
WO2018053928A1
WO2018053928A1 PCT/CN2016/107280 CN2016107280W WO2018053928A1 WO 2018053928 A1 WO2018053928 A1 WO 2018053928A1 CN 2016107280 W CN2016107280 W CN 2016107280W WO 2018053928 A1 WO2018053928 A1 WO 2018053928A1
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WIPO (PCT)
Prior art keywords
annuloplasty ring
inner core
mitral annuloplasty
artificial mitral
adjustment
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PCT/CN2016/107280
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English (en)
French (fr)
Inventor
虞奇峰
侯丽宏
王智杰
王海山
秦涛
Original Assignee
上海纽脉医疗科技有限公司
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Application filed by 上海纽脉医疗科技有限公司 filed Critical 上海纽脉医疗科技有限公司
Priority to US16/336,866 priority Critical patent/US10966831B2/en
Publication of WO2018053928A1 publication Critical patent/WO2018053928A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings
    • 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
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a manual mitral annuloplasty ring conveyor and a manual mitral annuloplasty ring delivery system.
  • Mitral valvuloplasty treats mitral regurgitation heart valve disease by implanting an artificial mitral annuloplasty ring.
  • An artificial mitral annuloplasty ring is used as part of mitral valvuloplasty to aid in the correction of heart valve defects such as mitral regurgitation.
  • the mitral valve includes the mitral annulus, leaflets, papillary muscles, and chordae.
  • Mitral regurgitation is the return of blood from the left ventricle through the mitral valve to the left atrium as the left ventricle contracts.
  • the expansion of the mitral annulus can block the ability of the valve to cause distortion of the normal shape of the valve orifice.
  • the artificial mitral annuloplasty ring is an important component of mitral valvuloplasty, and a suitable artificial mitral annuloplasty ring requires a suitable size and shape. Restoring the normal shape of the mitral annulus is a prerequisite for a good fit of the leaflets.
  • the choice of artificial mitral annuloplasty ring is currently largely determined by the doctor's personal experience and preferences.
  • the placement of a small prosthetic valve forming ring may lead to mitral stenosis, and the placement of an excessively large prosthetic valve forming ring affects the shaping effect of the height and area of the valve leaf.
  • the present invention by improving on a conventional mitral annuloplasty ring, provides an adjustable component on the artificial mitral valve annuloplasty ring to connect a specific artificial mitral annuloplasty ring conveyor to overcome the conventional Disadvantages of artificial mitral annuloplasty rings.
  • the doctor can make a secondary adjustment of the implanted artificial mitral annuloplasty ring, and timely adjust the size and shape of the mitral annuloplasty ring to improve the mitral valve formation. The purpose of the curative effect.
  • an artificial mitral annuloplasty ring comprising an internal threaded adjustment member for adjusting a size of a forming ring, the artificial mitral valve forming
  • the ring conveyor includes: an internally threaded adjustment member for adjusting a size of the forming ring, the artificial mitral forming ring conveyor comprising: a driving member, a connecting member disposed at a distal end of the driving member;
  • the connecting member comprises an outer tube, an intermediate tube and a regulating inner core
  • the driving member comprises an intermediate tube knob for adjusting the position of the intermediate tube and an inner core knob for adjusting the position of the adjusting inner core
  • One end of the outer tube is fixedly connected to the distal end of the driving component, and the other end of the outer tube is used for fixed connection with the adjusting component;
  • One end of the intermediate tube is connected to the middle tube button, and the other end of the middle tube penetrates the body cavity of the outer tube along the axial direction of the outer tube and exposes a part of the middle tube to expose the middle tube of the outer tube Provided with an external thread matching the internal thread of the adjusting member, the intermediate tube changing its position in the body cavity of the outer tube under the adjustment of the intermediate tube knob;
  • One end of the adjusting inner core is connected to the inner core knob, and the other end of the adjusting inner core penetrates a body cavity of the middle tube along an axial direction of the intermediate tube, and the adjusting inner core is at the inner core knob Under the adjustment, the telescopic movement is performed along the body cavity of the intermediate tube.
  • the artificial mitral annuloplasty ring conveyor further comprising a fixing claw for fixedly connecting the outer tube and the artificial mitral annuloplasty ring, the fixing claw being disposed on the The distal end of the outer tube.
  • the fixing claw is a nickel-titanium fixed claw, a medical stainless steel fixed claw or a cobalt-based alloy fixed claw.
  • the artificial mitral annuloplasty ring conveyor further comprising a displacement sliding block for driving the positional movement of the intermediate tube, the intermediate tube button passing through the displacement sliding block and the intermediate tube One end is connected, and the intermediate tube moves along the body cavity of the outer tube under the adjustment of the middle tube knob to match the external thread of the intermediate tube with the internal thread of the adjusting member.
  • the driving component further includes a scale indicator for indicating a state of the inner core knob.
  • the adjustment inner core includes a first adjustment inner core and a second adjustment inner core, and one end of the first adjustment inner core and the driving component Connected, the other end of the first adjustment core is coupled to the second adjustment core.
  • the shape of the first adjustment inner core is a cylinder
  • the shape of the second adjustment inner core is a rectangular parallelepiped shape, a cross shape or a star shape.
  • the intermediate tube includes a first segment and a second segment connected to the first segment, the first segment of the intermediate tube being along The axial direction of the outer tube penetrates the body cavity of the outer tube, the second section of the intermediate tube is outside the body cavity of the outer tube, and the external thread is disposed on the body wall of the second section of the intermediate tube.
  • the adjusting inner core is a nickel-titanium alloy adjusting inner core, a medical stainless steel adjusting inner core or a cobalt-based alloy regulating inner core.
  • the present invention also provides an artificial mitral annuloplasty delivery system comprising: an artificial mitral annuloplasty ring conveyor, and a distal end of the artificial mitral annuloplasty ring conveyor
  • a connected artificial mitral annuloplasty ring includes an internal threaded adjustment member for adjusting the size of the forming ring.
  • the artificial mitral annuloplasty ring further includes: a wire and a support coil, the support coil is sleeved on an outer side of the wire and The adjustment members collectively form a shape that matches the mitral annulus of the heart.
  • the adjustment component includes a housing, and a reel housed in the housing for winding the wire for fastening the Reel a spacer and a damping member for fastening the wound wire, the spacer and the damping member being disposed opposite to both ends of the spool; wherein the spool is provided with a shaft member in an axial direction, A through hole is formed on the gasket to expose the rotating shaft component, and the adjusting inner core abuts the rotating shaft component through the through hole.
  • the artificial mitral annuloplasty ring conveyor includes a driving component and a connection disposed at a distal end of the driving component
  • the component is based on the specific structure of the driving component and the connecting component.
  • the outer tube and the artificial mitral valve forming ring need to be fixedly connected, and then the external thread of the intermediate tube and the internal thread of the adjusting component are screwed and fixed, and then driven.
  • the end of the adjustment inner core is moved to switch with the adjustment member, and the rotation realizes adjustment of the adjustment member, thereby changing the size of the forming ring.
  • the artificial mitral annuloplasty ring conveyor of the present invention not only can transport the artificial mitral annuloplasty ring, but also can adjust the size of the artificial mitral annuloplasty ring after delivery, which meets the actual demand and improves the second.
  • the effect of valvuloplasty is not only can transport the artificial mitral annuloplasty ring, but also can adjust the size of the artificial mitral annuloplasty ring after delivery, which meets the actual demand and improves the second. The effect of valvuloplasty.
  • FIG. 1 is a schematic structural view of a manual mitral annuloplasty ring according to an embodiment of the present invention
  • FIG. 2 is a schematic structural view of a manual mitral annuloplasty ring delivery system according to an embodiment of the present invention
  • Figure 3 is an enlarged schematic view of a in Figure 2;
  • Figure 4 is an enlarged schematic view showing the matching of the external thread on the intermediate tube of Figure 3 with the internal thread of the adjusting member;
  • Figure 5 is a schematic view showing the structure of the adjusting inner core and the adjusting member in Figure 3;
  • Figure 6 is a schematic view showing the structure of a driving member in a manual mitral forming ring conveyor according to an embodiment of the present invention.
  • Artificial mitral annuloplasty ring 1 adjustment member 10; reel 11; spacer 12; shaft member 13; internal thread 14; manual mitral annuloplasty 2; drive member 20; inner core knob 200; ; scale indicator 202; connecting member 21; outer tube 210; intermediate tube 211; adjusting inner core 212; fixed claw 213; external thread 214.
  • the invention discloses an artificial mitral annuloplasty ring conveyor and a manual mitral annuloplasty ring delivery system capable of repairing a diseased mitral valve with a normal physiological shape and contour.
  • FIG. 1 and FIG. FIG. 2 is a schematic structural view of a manual mitral annuloplasty ring delivery system in the present embodiment.
  • the artificial mitral annuloplasty ring delivery system includes: an artificial mitral annuloplasty ring conveyor 2, and a manual mitral valve formation coupled to the distal end of the artificial mitral annuloplasty ring conveyor 2 Ring 1, the artificial mitral annuloplasty ring 1 comprises an adjustment member 10 (shown in Figure 1) having an internal thread 14 for adjusting the size of the forming ring.
  • the so-called distal end in the present invention refers to one end away from the operator, and the proximal end is an end close to the operator.
  • the artificial mitral annuloplasty ring 1 further comprises: a wire and a supporting coil, the supporting coil is sleeved on the outer side of the wire and together with the adjusting component 10 to form a shape matching the mitral annulus of the heart.
  • the adjustment of the length of the wire by the adjusting member 10 causes the support coil to contract or expand radially, thereby realizing the adjustment of the size of the artificial mitral annuloplasty ring 1 for accurate adjustment.
  • the artificial mitral annuloplasty ring forms a shape that matches the mitral annulus of the heart.
  • FIG. 3 is an enlarged schematic view of a in FIG. 2;
  • FIG. 4 is an enlarged schematic view showing the matching of the external thread on the intermediate tube of FIG. 3 with the internal thread of the adjusting member;
  • FIG. The structural schematic diagram of adjusting the inner core and the adjusting component when docking.
  • the adjustment member 10 includes a housing, a reel 11 housed in the housing for winding the wire, a spacer 12 for fastening the reel 11, and a damping member for fastening the wound wire
  • the spacer 12 and the damping member are oppositely disposed At the two ends of the reel 11; in order to rotate the reel 11, thereby achieving winding of the wire on the reel 11, the reel 11 is provided with a rotating shaft member 13 in the axial direction, and the shim 12 is provided with an exposed portion
  • the through hole of the shaft member 13 is connected to the shaft member through the through hole, thereby providing an interface for the subsequent docking of the manual mitral forming ring conveyor 2 and the adjusting member 10.
  • the internal thread 14 of the adjusting member 10 is distributed on the inner side of the housing.
  • the manual mitral forming ring conveyor 2 includes a driving component 20 and a connecting component 21 disposed at a distal end of the driving component 20; wherein the connecting component 21 includes an outer tube 210, the intermediate tube 211 and the adjusting inner core 212; the driving component 20 includes an intermediate tube knob 201 for adjusting the position of the intermediate tube 211 and an inner core knob 200 for adjusting the position of the adjusting inner core 212; One end of the outer tube 210 is fixedly connected to the distal end of the driving member 20, and the other end of the outer tube 210 is for fixed connection with the adjusting member 10; one end of the intermediate tube 211 and the middle tube knob 201 Connecting, the other end of the intermediate tube 211 penetrates the body cavity of the outer tube 210 in the axial direction of the outer tube 210 and exposes a portion of the intermediate tube 211, and the intermediate tube 211 exposing the outer tube 210 is disposed on the middle tube 211
  • the internal thread 14 of the adjustment member 10 matches the external thread
  • the drive member 20 further includes a scale indicator 202 for indicating the state of the inner core knob 200.
  • the inner core knob 200 can be rotated clockwise or counterclockwise.
  • the inner core knob 200 rotates clockwise or counterclockwise, correspondingly, the inner core 212 is adjusted with the inner core knob 200.
  • the scale indicator 202 is convenient for the operator to know the inner diameter size information of the artificial mitral annuloplasty ring.
  • the principle is that the scale on the scale indicator 202 is based on the distance relationship between the linear motion of the indicator and the number of revolutions of the knob. For a positive correlation function, the number of rotated turns is a positive correlation between the number of turns of the reel or the length of the expanding wire, and For the purpose of knowing the size change of the artificial mitral annuloplasty ring.
  • the rotating shaft component that abuts the adjusting inner core receives a corresponding force, thereby driving the reel to rotate in the same direction as the adjusting inner core, thereby
  • the winding or unwinding of the wire on the reel is realized, and the supporting coil of the outer sleeve of the wire is in an expanded state or a tightened state, and the overall size change of the artificial mitral forming ring is realized.
  • the overall size of the artificial mitral annuloplasty ring is changed by the principle that the state of the support coil changes with the change of the length of the wire therein; the wire becomes long, and the support coil exhibits expansion.
  • the wire is shortened and the support coil is in a tightened state. Therefore, when the inner core knob 200 drives the adjustment inner core to rotate counterclockwise, the reel also rotates counterclockwise, and the wire becomes longer, the support coil exhibits an expanded state; otherwise, the state is tightened.
  • the relationship between the direction of rotation of the reel and the state exhibited by the support coil includes, but is not limited to, the above-described case, and the specific correspondence thereof depends on the relationship between the wire and the reel.
  • the artificial mitral annuloplasty ring conveyor further includes a fixing claw 213 for fixedly connecting the outer tube 210 and the artificial mitral annuloplasty ring 1.
  • the fixing claw 213 is disposed on The distal end of the outer tube 210.
  • the fixing claw 213 serves as a medium for the fixed connection between the outer tube 210 and the artificial mitral annuloplasty ring 1 , and provides a fulcrum for the matching rotation of the thread on the intermediate tube 211 and the internal thread 14 of the adjusting member 10 .
  • the outer tube 210 is relatively stationary with the artificial mitral annuloplasty ring 1.
  • the fixing claw is a nickel titanium alloy fixing claw, a medical stainless steel fixing claw or a cobalt-based alloy fixing claw.
  • the manual mitral annuloplasty ring conveyor further includes a displacement sliding block (not shown) for driving the positional movement of the intermediate tube 211, the intermediate tube button passing through the displacement sliding block and the intermediate tube 211
  • a displacement sliding block (not shown) for driving the positional movement of the intermediate tube 211, the intermediate tube button passing through the displacement sliding block and the intermediate tube 211
  • One end of the intermediate tube 211 is moved along the body cavity of the outer tube 210 under the adjustment of the intermediate tube knob 201 to match the external thread 214 of the intermediate tube 211 with the internal thread 14 of the adjustment member .
  • the adjustment inner core 212 includes a first adjustment inner core and a second adjustment inner core, one end of the first adjustment inner core is connected to the driving component 20, and the first adjustment inner core is further One end Connected to the second conditioning core.
  • the shape of the first adjustment inner core is a cylinder, is accommodated in the intermediate tube, and defines a range for adjusting the movement of the inner core; and the shape of the second adjustment inner core includes but is not limited to a rectangular parallelepiped, a cross or a star type.
  • the design of the rotating shaft member of the adjusting member can be selected according to the specific structure.
  • the structure of the second adjusting inner core can be matched with the structure of the rotating shaft member of the adjusting member.
  • the adjusting inner core is a nickel-titanium alloy adjusting inner core, a medical stainless steel adjusting inner core or a cobalt-based alloy regulating inner core.
  • the intermediate tube includes a first segment and a second segment connected to the first segment, and a first segment of the intermediate tube penetrates a body cavity of the outer tube along an axial direction of the outer tube,
  • the second section of the intermediate tube is outside the body cavity of the outer tube, and the external thread is disposed on the body wall of the second section of the intermediate tube.
  • the internal thread on the inner side of the housing of the adjusting member is rotationally fixed by the external thread on the body wall of the second section of the intermediate tube, and the movement passage required to adjust the inner core to the adjusting member is constructed.
  • the intermediate tube is made of HDPE or PP.
  • the artificial mitral annuloplasty ring conveyor when the artificial mitral annuloplasty ring conveyor is externally connected to the adjusting component, the artificial mitral annuloplasty ring conveyor is actually matched with the rotating shaft component 13 of the adjusting component, thereby facilitating the subsequent manual cusp Adjustment of the adjustment member by the flap forming ring conveyor.
  • the rotating shaft member 13 is a groove structure. More preferably, the groove structure is a groove-shaped groove; and one end of the artificial mitral forming ring conveyor and the rotating shaft member 13 are matched and connected. A convex structure is formed which is matched with the groove structure. If the groove structure is a groove having a shape, the convex structure is a flat protrusion.
  • the convex structure is a structure for adjusting the distal end of the inner core.
  • the connecting member is a flexible connecting member
  • the artificial mitral forming ring conveyor extending sheath can be made of a flexible material or a rigid material. It is preferably a flexible material that facilitates adjustment of the size and shape of the artificial mitral annuloplasty ring and can be flexibly delivered as needed.
  • the outer tube 210 is fixedly connected to the artificial mitral annuloplasty ring 1 by a fixing claw 213 at the distal end of the outer tube 210;
  • the intermediate tube knob 201 is used to control the movement of the intermediate tube 211 along its axial direction to make The external thread 214 of the intermediate tube 211 is screwed and fixed to the internal thread 14 of the adjusting member 10;
  • the inner core knob 200 is used to drive the end of the adjustment inner core 212 to move to and
  • the rotating shaft member 13 of the adjusting member 10 is butted to rotate the inner core knob 200 in a predetermined direction, so that the adjusting inner core 212 also performs a rotating motion, thereby driving the reel 11 where the butt shaft member 13 is butted to rotate, thereby realizing the change of the length of the wire. Change the size of the forming ring.
  • the prosthetic mitral valve is provided in the present invention.
  • the ring conveyor includes a driving component and a connecting component disposed at a distal end of the driving component; based on the specific structure of the driving component and the connecting component, in actual application, the outer tube and the artificial mitral annuloplasty ring need to be fixedly connected first, and then After the external thread of the intermediate tube is screwed to the internal thread of the adjusting member, the end of the driving adjustment core is moved to switch with the adjusting member, and the rotation adjusts the adjusting member to change the size of the forming ring.
  • the artificial mitral annuloplasty ring conveyor of the present invention not only can transport the artificial mitral annuloplasty ring, but also can adjust the size of the artificial mitral annuloplasty ring after delivery, which meets the actual demand and improves the second.
  • the effect of valvuloplasty is not only can transport the artificial mitral annuloplasty ring, but also can adjust the size of the artificial mitral annuloplasty ring after delivery, which meets the actual demand and improves the second. The effect of valvuloplasty.

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

Abstract

一种人工二尖瓣成形环（1），包括导线、用于调节导线长度的调节部件（10）、用于调节二尖瓣成形环（1）径向尺寸的支撑线圈；支撑线圈套接于导线的外侧并与调节部件（10）共同构成与心脏二尖瓣环匹配的形状。通过常规的外科手术缝合方式植入，当患者心脏恢复跳动状态下，人工二尖瓣成形环（1）的调节部件（10）外接可旋转输送器（2），调节部件（10）在可旋转输送器（2）的旋转作用下调节导线的长度进而使得二尖瓣成形环（1）尺寸收缩或扩张，以准确调节人工二尖瓣成形环（1）构成与心脏二尖瓣瓣环相匹配的形状，从而有效解决二尖瓣关闭不全问题。

Description

人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统 技术领域
本发明涉及医疗器械技术领域，特别涉及一种人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统。
背景技术
二尖瓣成形术通过植入人工二尖瓣膜成形环来治疗二尖瓣反流心脏瓣膜疾病。人工二尖瓣成形环用作二尖瓣成形术的一部分以辅助心脏瓣膜缺陷(如二尖瓣关闭不全)的矫正。二尖瓣包括二尖瓣瓣环、瓣叶、乳头肌和腱索。二尖瓣反流是当左心室收缩时血液从左心室通过二尖瓣到左心房的回流。二尖瓣瓣环的扩张能阻止瓣膜的能力，从而导致瓣膜口正常形状的扭曲。
人工二尖瓣成形环是二尖瓣成形术的重要组成部分，采用合适的人工二尖瓣成形环，需要合适的尺寸和形状。恢复二尖瓣瓣环正常的外形是使瓣叶良好对合的前提。但是对于人工二尖瓣成形环的选择，目前很大程度上取决于医生的个人经验和喜好。患者置入过小的人工瓣膜成形环可能带来二尖瓣狭窄，而置入过大的人工瓣膜成形环又影响瓣叶对合高度和面积影响成形效果。
在传统的二尖瓣成形术中需要利用心肺转流术在心脏停跳下进行操作。准确测量二尖瓣环尺寸并判断修复效果是非常困难的事情。鉴于此，本发明，通过在传统的二尖瓣瓣膜成形环上进行改进，在人工二尖瓣瓣膜成形环上设置有可调节部件，连接特定的人工二尖瓣成形环输送器，可克服传统人工二尖瓣成形环的缺点。借助于人工二尖瓣成形环输送装置，在术中，医生可以对植入的人工二尖瓣成形环进行二次调整，及时调整二尖瓣成形环尺寸与形状，以达到提高二尖瓣成形术疗效的目的。
发明内容
本发明的目的在于提供一种人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统，以弥补现有技中没有可以调节人工二尖瓣成形环尺寸的输送器问题。
为解决上述技术问题，本发明提供一种人工二尖瓣成形环输送器，所述人工二尖瓣成形环包括用于调节成形环尺寸的具有内螺纹的调节部件，所述人工二尖瓣成形环输送器包括：用于调节成形环尺寸的具有内螺纹的调节部件，所述人工二尖瓣成形环输送器包括：驱动部件、设置于所述驱动部件的远端的连接部件；
其中，所述连接部件包括外管、中间管及调节内芯；所述驱动部件包括用于调节所述中间管位置的中间管旋钮及用于调节所述调节内芯位置的内芯旋钮；
所述外管的一端与所述驱动部件的远端固定连接，所述外管的另一端用于与所述调节部件固定连接；
所述中间管的一端与所述中间管钮连接，所述中间管的另一端沿所述外管的轴向贯穿所述外管的体腔并露出部分中间管，露出所述外管的中间管上设置有与所述调节部件的内螺纹匹配的外螺纹，所述中间管在所述中间管旋钮的调节下改变其在所述外管的体腔中的位置；
所述调节内芯的一端与所述内芯旋钮连接，所述调节内芯的另一端沿所述中间管的轴向贯穿所述中间管的体腔，所述调节内芯在所述内芯旋钮的调节下沿所述中间管的体腔做伸缩运动。
可选的，在所述的人工二尖瓣成形环输送器中，还包括用于将所述外管与所述人工二尖瓣成形环固定连接的固定爪，所述固定爪设置于所述外管的远端。
可选的，在所述的人工二尖瓣成形环输送器中，所述固定爪为镍钛合金固定爪、医用不锈钢固定爪或钴基合金固定爪。
可选的，在所述的人工二尖瓣成形环输送器中，还包括用于带动所述中间管位置移动的位移滑动块，所述中间管钮通过所述位移滑动块与所述中间管的一端连接，所述中间管在所述中间管旋钮的调节下沿所述外管的体腔移动，以使所述中间管的外螺纹与所述调节部件的内螺纹匹配。
可选的，在所述的人工二尖瓣成形环输送器中，所述驱动部件还包括用于指示所述内芯旋钮的状态的标尺指示器。
可选的，在所述的人工二尖瓣成形环输送器中，所述调节内芯包括第一调节内芯及第二调节内芯，所述第一调节内芯的一端与所述驱动部件连接，所述第一调节内芯的另一端与所述第二调节内芯连接。
可选的，在所述的人工二尖瓣成形环输送器中，所述第一调节内芯的形状为圆柱体，所述第二调节内芯的形状为长方体、十字型或者星型。
可选的，在所述的人工二尖瓣成形环输送器中，所述中间管包括第一段及与所述第一段连接的第二段，所述中间管的第一段沿所述外管的轴向贯穿所述外管的体腔，所述中间管的第二段处于所述外管的体腔外，所述外螺纹设置于所述中间管的第二段的体壁上。
可选的，在所述的人工二尖瓣成形环输送器中，所述调节内芯为镍钛合金调节内芯、医用不锈钢调节内芯或钴基合金调节内芯。
本发明还提供一种人工二尖瓣成形环输送系统，所述人工二尖瓣成形环输送系统包括：人工二尖瓣成形环输送器、及与所述人工二尖瓣成形环输送器远端连接的人工二尖瓣成形环，所述人工二尖瓣成形环包括用于调节成形环尺寸的具有内螺纹的调节部件。
可选的，在所述的人工二尖瓣成形环输送系统中，所述人工二尖瓣成形环还包括：导线及支撑线圈，所述支撑线圈套接于所述导线的外侧并与所述调节部件共同构成与心脏二尖瓣环匹配的形状。
可选的，在所述的人工二尖瓣成形环输送系统中，所述调节部件包括壳体、及容置于所述壳体内的用于缠绕所述导线的卷轴、用于紧固所述卷轴的 垫片和用于紧固缠绕导线的阻尼部件，所述垫片和所述阻尼部件相对的设置于所述卷轴的两端；其中，所述卷轴的轴向方向上设置有转轴部件，所述垫片上开设有外露所述转轴部件的通孔，所述调节内芯通过所述通孔与所述转轴部件对接。
在本发明所提供的人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统中，所述人工二尖瓣成形环输送器包括驱动部件、设置于所述驱动部件的远端的连接部件；基于驱动部件及连接部件的具体结构，实际应用时，需要先将外管与人工二尖瓣成形环固定连接，再将中间管的外螺纹与调节部件的内螺纹旋紧固定后，驱动调节内芯的末端移动至与所述调节部件开关，旋转实现对调节部件的调节，进而改变成形环尺寸。由此可见，本发明的人工二尖瓣成形环输送器不仅可以对人工二尖瓣成形环进行输送，还可以对输送后的人工二尖瓣成形环进行尺寸调节，符合实际需求，提高了二尖瓣成形术疗效。
附图说明
图1是本发明一实施例中人工二尖瓣成形环的结构示意图；
图2是本发明一实施例中人工二尖瓣成形环输送系统的结构示意图；
图3是图2中a的放大示意图；
图4是图3中中间管上的外螺纹与调节部件的内螺纹匹配的放大示意图；
图5是图3中调节内芯与调节部件对接时的结构示意图；
图6是本发明一实施例中人工二尖瓣成形环输送器中驱动部件的结构示意图。
图中：
人工二尖瓣成形环1；调节部件10；卷轴11；垫片12；转轴部件13；内螺纹14；人工二尖瓣成形环输送器2；驱动部件20；内芯旋钮200；中间管旋钮201；标尺指示器202；连接部件21；外管210；中间管211；调节内芯 212；固定爪213；外螺纹214。
具体实施方式
以下结合附图和具体实施例对本发明提出的人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统作进一步详细说明。根据下面说明和权利要求书，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
本发明公开了一种可修复病变二尖瓣为正常生理形状和轮廓的人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统，请参考图1及图2，图1为本实施例中人工二尖瓣成形环的结构示意图；图2为本实施例中人工二尖瓣成形环输送系统的结构示意图。如图2所示，所述人工二尖瓣成形环输送系统包括：人工二尖瓣成形环输送器2、及与所述人工二尖瓣成形环输送器2远端连接的人工二尖瓣成形环1，所述人工二尖瓣成形环1包括用于调节成形环尺寸的具有内螺纹14的调节部件10(如图1所示)。本发明中所谓的远端均指远离操作者的一端，近端为靠近操作者的一端。
其中，所述人工二尖瓣成形环1还包括：导线及支撑线圈，所述支撑线圈套接于所述导线的外侧并与所述调节部件10共同构成与心脏二尖瓣环匹配的形状。在人工二尖瓣成形环常规缝合手术方法植入后，通过调节部件10对导线长度的调节使得支撑线圈沿径向收缩或扩张，从而实现人工二尖瓣成形环1尺寸的调节，以准确调节人工二尖瓣成形环构成与心脏二尖瓣瓣环相匹配的形状。
请参考图3、图4及图5，图3是图2中a的放大示意图；图4是图3中中间管上的外螺纹与调节部件的内螺纹匹配的放大示意图；图5是图3中调节内芯与调节部件对接时的结构示意图。所述调节部件10包括壳体、及容置于所述壳体内的用于缠绕所述导线的卷轴11、用于紧固所述卷轴11的垫片12和用于紧固缠绕导线的阻尼部件，所述垫片12和所述阻尼部件相对的设置 于所述卷轴11的两端；为了使得卷轴11转动，从而实现导线在卷轴11上的缠绕，所述卷轴11的轴向方向上设置有转轴部件13，所述垫片12上开设有外露所述转轴部件13的通孔，所述调节内芯通过所述通孔与所述转轴部件对接，从而为后续人工二尖瓣成形环输送器2与调节部件10的对接提供接口。其中，所述调节部件10的内螺纹14分布于所述壳体的内侧。
请参考图4及图6，所述人工二尖瓣成形环输送器2包括：驱动部件20及设置于所述驱动部件20的远端的连接部件21；其中，所述连接部件21包括外管210、中间管211及调节内芯212；所述驱动部件20包括用于调节所述中间管211位置的中间管旋钮201及用于调节所述调节内芯212位置的内芯旋钮200；所述外管210的一端与所述驱动部件20的远端固定连接，所述外管210的另一端用于与所述调节部件10固定连接；所述中间管211的一端与所述中间管旋钮201连接，所述中间管211的另一端沿所述外管210的轴向贯穿所述外管210的体腔并露出部分中间管211，露出所述外管210的中间管211上设置有与所述调节部件10的内螺纹14匹配的外螺纹214，所述中间管211在所述中间管旋钮201的调节下改变其在所述外管210的体腔中的位置；所述调节内芯212的一端与所述内芯旋钮200连接，所述调节内芯212的另一端沿所述中间管211的轴向贯穿所述中间管211的体腔，所述调节内芯212在所述内芯旋钮200的调节下沿所述中间管211的体腔做伸缩运动。本实施例中，所述驱动部件优选为驱动手柄，所述外管的材质为HDPE或PP。
如图6所示，所述驱动部件20还包括用于指示所述内芯旋钮200的状态的标尺指示器202。本实施例中，内芯旋钮200可沿顺时针或逆时针旋转，在所述内芯旋钮200沿顺时针或逆时针旋转时，相应的，调节内芯212会与所述内芯旋钮200做方向一致的旋转运动。所述标尺指示器202便于操作者较为直观的获知人工二尖瓣成形环内径尺寸信息，其原理是：所述标尺指示器202上的刻度根据指示器直线运动的距离关系与旋钮旋转的圈数为正相关函数，已旋转的圈数与卷轴收缩或扩张导线的长度成正相关函数关系，进而作 为获知人工二尖瓣成形环尺寸改变的参考。
具体的，在内芯旋钮200控制调节内芯作旋转运动时，与所述调节内芯对接的转轴部件会受到相应的作用力，进而驱动卷轴以与调节内芯相同的方向作旋转运动，从而实现导线在卷轴上的缠绕或解绕，导线外侧套接的支撑线圈呈现扩张状态或收紧状态，实现人工二尖瓣成形环的整体尺寸改变。本实施例中，人工二尖瓣成形环的整体尺寸改变其原理在于：所述支撑线圈的状态随其内的所述导线长度的改变而改变；所述导线变长，所述支撑线圈呈现扩张状态；所述导线变短，所述支撑线圈呈现收紧状态。因此，当内芯旋钮200驱动调节内芯逆时针旋转时，卷轴也逆时针旋转，导线变长，则支撑线圈呈现扩张状态；反之，收紧状态。卷轴的旋转方向与支撑线圈呈现的状态之间关系包括但不局限于上述情况，其具体对应关系，需要根据导线与卷轴缠绕的关系而定。
请继续参考图3，所述人工二尖瓣成形环输送器还包括用于将所述外管210与所述人工二尖瓣成形环1固定连接的固定爪213，所述固定爪213设置于所述外管210的远端。所述固定爪213作为所述外管210与所述人工二尖瓣成形环1固定连接的媒介，为后续中间管211上的螺纹与所述调节部件10的内螺纹14进行匹配旋转时提供支点，使得外管210与人工二尖瓣成形环1相对静止。优选的，所述固定爪为镍钛合金固定爪、医用不锈钢固定爪或钴基合金固定爪。
所述人工二尖瓣成形环输送器还包括用于带动所述中间管211位置移动的位移滑动块(图中未示)，所述中间管钮通过所述位移滑动块与所述中间管211的一端连接，所述中间管211在所述中间管旋钮201的调节下沿所述外管210的体腔移动，以使所述中间管211的外螺纹214与所述调节部件的内螺纹14匹配。
本实施例中，所述调节内芯212包括第一调节内芯及第二调节内芯，所述第一调节内芯的一端与所述驱动部件20连接，所述第一调节内芯的另一端 与所述第二调节内芯连接。优选的，所述第一调节内芯的形状为圆柱体，容置于中间管内，限定调节内芯运动的范围；所述第二调节内芯的形状包括但不局限于长方体、十字型或者星型。可以根据调节部件的转轴部件的具体结构进行选择设计，最终实现人工二尖瓣成形环输送器与调节部件外接时，第二调节内芯的结构能够与调节部件的转轴部件的结构匹配对接。优选的，所述调节内芯为镍钛合金调节内芯、医用不锈钢调节内芯或钴基合金调节内芯。
进一步地，所述中间管包括第一段及与所述第一段连接的第二段，所述中间管的第一段沿所述外管的轴向贯穿所述外管的体腔，所述中间管的第二段处于所述外管的体腔外，所述外螺纹设置于所述中间管的第二段的体壁上。通过所述中间管的第二段的体壁上的外螺纹实现中间管与调节部件的壳体内侧的内螺纹旋转固定，构建调节内芯与调节部件对接所需的运动通道。优选的，所述中间管的材质为HDPE或PP。
请继续参考图5，人工二尖瓣成形环输送器与调节部件外接时，实际上所述人工二尖瓣成形环输送器与调节部件的所述转轴部件13匹配连接，从而便于后续人工二尖瓣成形环输送器对调节部件的调节。优选的，所述转轴部件13为一凹槽结构，更优选的，所述凹槽结构为一字型凹槽；所述人工二尖瓣成形环输送器与所述转轴部件13匹配连接的一端设置有与所述凹槽结构相吻合的凸起结构，若所述凹槽结构为以一字型凹槽，此时所述凸起结构为一字型凸起。本实施例中，所述凸起结构为调节内芯的远端的结构。其中，所述连接部件为柔性连接部件，所述人工二尖瓣成形环输送器延长鞘管可以由柔性材料或者刚性材料制备。优选为柔性材料，便于调节人工二尖瓣成形环的尺寸和形状，并且可根据需要弯曲输送。
结合图1、图2及图5理解本发明的人工二尖瓣成形环输送器的应用方法：
首先，通过外管210远端的固定爪213将外管210与所述人工二尖瓣成形环1固定连接；
接着，利用中间管旋钮201控制中间管211沿其轴向方向运动，以使中 间管211的外螺纹214与所述调节部件10的内螺纹14旋紧固定；
接着，利用驱动部件20驱动人工二尖瓣成形环1输送至预定位置后，若需要对人工二尖瓣成形环1进行尺寸调节，则利用内芯旋钮200驱动调节内芯212的末端移动至与所述调节部件10的转轴部件13对接，沿预定方向旋转内芯旋钮200，使得调节内芯212也做旋转运动，进而带动与其对接的转轴部件13所在的卷轴11旋转，实现导线长度的改变，改变成形环尺寸。
综上，在本发明所提供的一种可修复病变二尖瓣为正常生理形状和轮廓的人工二尖瓣成形环输送器及人工二尖瓣成形环输送系统中，所述人工二尖瓣成形环输送器包括驱动部件、设置于所述驱动部件的远端的连接部件；基于驱动部件及连接部件的具体结构，实际应用时，需要先将外管与人工二尖瓣成形环固定连接，再将中间管的外螺纹与调节部件的内螺纹旋紧固定后，驱动调节内芯的末端移动至与所述调节部件开关，旋转实现对调节部件的调节，进而改变成形环尺寸。由此可见，本发明的人工二尖瓣成形环输送器不仅可以对人工二尖瓣成形环进行输送，还可以对输送后的人工二尖瓣成形环进行尺寸调节，符合实际需求，提高了二尖瓣成形术疗效。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (12)

  1. 一种人工二尖瓣成形环输送器，其特征在于，所述人工二尖瓣成形环包括用于调节成形环尺寸的具有内螺纹的调节部件，所述人工二尖瓣成形环输送器包括：驱动部件、设置于所述驱动部件的远端的连接部件；
    其中，所述连接部件包括外管、中间管及调节内芯；所述驱动部件包括用于调节所述中间管位置的中间管旋钮及用于调节所述调节内芯位置的内芯旋钮；
    所述外管的一端与所述驱动部件的远端固定连接，所述外管的另一端用于与所述调节部件固定连接；
    所述中间管的一端与所述中间管旋钮连接，所述中间管的另一端沿所述外管的轴向贯穿所述外管的体腔并露出部分中间管，露出所述外管的中间管部分上设置有与所述调节部件的内螺纹匹配的外螺纹，所述中间管在所述中间管旋钮的调节下改变其在所述外管的体腔中的位置；
    所述调节内芯的一端与所述内芯旋钮连接，所述调节内芯的另一端沿所述中间管的轴向贯穿所述中间管的体腔，所述调节内芯在所述内芯旋钮的调节下沿所述中间管的体腔做伸缩运动。
  2. 如权利要求1所述的人工二尖瓣成形环输送器，其特征在于，还包括用于将所述外管与所述人工二尖瓣成形环固定连接的固定爪，所述固定爪设置于所述外管的远端。
  3. 如权利要求2所述的人工二尖瓣成形环输送器，其特征在于，所述固定爪为镍钛合金固定爪、医用不锈钢固定爪或钴基合金固定爪。
  4. 如权利要求1所述的人工二尖瓣成形环输送器，其特征在于，还包括用于带动所述中间管位置移动的位移滑动块，所述中间管旋钮通过所述位移滑动块与所述中间管的一端连接，所述中间管在所述中间管旋钮的调节下沿所述外管的体腔移动，以使所述中间管的外螺纹与所述调节部件的内螺纹匹配。
  5. 如权利要求1所述的人工二尖瓣成形环输送器，其特征在于，所述驱 动部件还包括用于指示所述内芯旋钮的状态的标尺指示器。
  6. 如权利要求1所述的人工二尖瓣成形环输送器，其特征在于，所述调节内芯包括第一调节内芯及第二调节内芯，所述第一调节内芯的一端与所述驱动部件连接，所述第一调节内芯的另一端与所述第二调节内芯连接。
  7. 如权利要求6所述的人工二尖瓣成形环输送器，其特征在于，所述第一调节内芯的形状为圆柱体，所述第二调节内芯的形状为长方体、十字型或者星型。
  8. 如权利要求1所述的人工二尖瓣成形环输送器，其特征在于，所述中间管包括第一段及与所述第一段连接的第二段，所述中间管的第一段沿所述外管的轴向贯穿所述外管的体腔，所述中间管的第二段处于所述外管的体腔外，所述外螺纹设置于所述中间管的第二段的体壁上。
  9. 如权利要求1所述的人工二尖瓣成形环输送器，其特征在于，所述调节内芯为镍钛合金调节内芯、医用不锈钢调节内芯或钴基合金调节内芯。
  10. 一种人工二尖瓣成形环输送系统，其特征在于，包括如权利要求1～5中任一项所述的人工二尖瓣成形环输送器、及与所述人工二尖瓣成形环输送器远端连接的人工二尖瓣成形环，所述人工二尖瓣成形环包括用于调节成形环尺寸的具有内螺纹的调节部件。
  11. 如权利要求10所述的人工二尖瓣成形环输送系统，其特征在于，所述人工二尖瓣成形环还包括：导线及支撑线圈，所述支撑线圈套接于所述导线的外侧并与所述调节部件共同构成与心脏二尖瓣环匹配的形状。
  12. 如权利要求11所述的人工二尖瓣成形环输送系统，其特征在于，所述调节部件包括壳体、及容置于所述壳体内的用于缠绕所述导线的卷轴、用于紧固所述卷轴的垫片和用于紧固缠绕导线的阻尼部件，所述垫片和所述阻尼部件相对的设置于所述卷轴的两端；其中，所述卷轴的轴向方向上设置有转轴部件，所述垫片上开设有外露所述转轴部件的通孔，所述调节内芯通过所述通孔与所述转轴部件对接。
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