WO2023116368A1 - 瓣膜修复装置及瓣膜修复*** - Google Patents

瓣膜修复装置及瓣膜修复*** Download PDF

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Publication number
WO2023116368A1
WO2023116368A1 PCT/CN2022/135235 CN2022135235W WO2023116368A1 WO 2023116368 A1 WO2023116368 A1 WO 2023116368A1 CN 2022135235 W CN2022135235 W CN 2022135235W WO 2023116368 A1 WO2023116368 A1 WO 2023116368A1
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WIPO (PCT)
Prior art keywords
arm
clamping arm
clamping
rotatably connected
drive shaft
Prior art date
Application number
PCT/CN2022/135235
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English (en)
French (fr)
Inventor
张婧
陈国明
刘世红
Original Assignee
上海微创心通医疗科技有限公司
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Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Publication of WO2023116368A1 publication Critical patent/WO2023116368A1/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
    • 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

Definitions

  • the present application relates to the technical field of medical devices, in particular to a valve repair device and a valve repair system.
  • the human heart is divided into four chambers: the left atrium, the left ventricle, the right atrium, and the right ventricle.
  • the two atria are connected to the two ventricles, and the two ventricles are connected to the two great arteries.
  • the mitral valve grows between the left atrium and left ventricle, and consists of leaflets, valve ring, chordae and papillary muscles, which act as a one-way valve to ensure that blood flow is only allowed to move in one direction from the left atrium to the left ventricle.
  • Mitral regurgitation one of the most common mitral valve disorders, refers to the reverse flow of blood from the left ventricle into the left atrium when the mitral valve fails to close properly during the systolic phase.
  • mitral valve repair devices are commonly used.
  • the mitral valve repair device is an implantable prosthesis, which generally includes a driving rod, a transmission arm, a fixed point, a clamping mechanism and a locking mechanism.
  • the fixed point is fixed, and the driving rod slides through the middle of the fixed point.
  • the driving rod slides up and down to drive the clamping mechanism to move, and the clamping mechanism clamps the leaflets and fixes the two leaflets together to reduce blood reflux.
  • the driving rod cooperates with the locking mechanism to realize the locking function.
  • the locking position is determined by the length of the driving rod and the setting of the locking mechanism. When the driving rod reaches the appropriate position, manual operation is required.
  • the locking mechanism locks the driving rod, and this locking process is often intermittent, and the locking mechanism has a complex structure and cumbersome operation.
  • a valve repair device and a valve repair system are provided.
  • the present application provides a valve repair device, comprising a fixing base, a driving shaft and a clamping structure, the clamping structure is rotatably connected to the fixing base, the driving shaft is threadedly connected to the fixing base, and the The driving shaft can move up and down relative to the fixed seat to drive the clamping structure to rotate toward or away from the fixed seat.
  • the present application provides a valve repair device, which includes a fixing base, a driving shaft and a clamping structure, the clamping structure is rotatably connected to the fixing base, the driving shaft is screwed to the fixing base, and the The clamping structure is drivingly connected to the drive shaft, and when the drive shaft rotates relative to the fixed seat, the drive shaft moves relative to the fixed seat and drives the clamping structure toward or away from the fixed seat turn.
  • the present application provides a valve repair system, including the above-mentioned valve repair device and a delivery device, the delivery device includes a driving member, the driving member is detachably connected to the driving shaft, and the driving member is used for The drive shaft is driven to rotate relative to the fixed seat.
  • FIG. 1 is a schematic diagram of a valve repair device according to an embodiment of the present application
  • FIG. 2 is a schematic diagram of a valve repair device according to another embodiment of the present application.
  • FIG. 3 is a schematic diagram of a valve repair device according to another embodiment of the present application.
  • FIG. 4 is a schematic diagram of a heart without a valve repair device
  • FIG. 5 is a schematic diagram of a heart implanted with a valve repair device according to an embodiment of the present application.
  • leaflet 10. fixed seat; 20. drive shaft; 210. second thread; 30. clamping structure; 301. barb; 310a. first clamping arm; 320a. second clamping arm; 330a. 340a, the second transmission arm; 350a, the third clamping arm; 360a, the fourth clamping arm; 310b, the first clamping arm; 320b, the second clamping arm; 330b, the first transmission arm ; 340b, the second transmission arm; 350b, the third clamping arm; 360b, the fourth clamping arm; 40, the connecting seat.
  • first and second are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise specifically defined.
  • An embodiment of the present application provides a valve repair system, including a valve repair device and a delivery device.
  • the valve repair device is pushed into the patient's body through the delivery device.
  • the valve repair device adopts implantable metal materials, such as titanium alloy, cobalt-chromium alloy, etc.; or adopts implantable polymer materials, such as PLA and the like.
  • the operator pushes the valve repair device from the outside of the patient's body to the patient's body through the delivery device.
  • the up and down positions mentioned below refer to: the direction close to the operator is up, and the direction away from the operator is down.
  • the valve repair device includes a fixing base 10 , a driving shaft 20 and a clamping structure 30 .
  • the clamping structure 30 is rotatably connected with the fixing base 10 .
  • the drive shaft 20 is threadedly connected to the fixed seat 10, so that when the drive shaft 20 rotates relative to the fixed seat 10, under the action of this threaded fit, the drive shaft 20 is axially (ie, the length direction of the drive shaft 20) relative to the fixed seat. 10 moves.
  • the drive shaft 20 is screwed to the fixed seat 10, which means that only when the drive shaft 20 and the fixed seat 10 rotate relatively, there will be a shaft between the drive shaft 20 and the fixed seat 10.
  • the clamping structure 30 is drivingly connected to the drive shaft 20 .
  • the driving shaft 20 can move up and down relative to the fixing base 10 to drive the clamping structure 30 to rotate toward or away from the fixing base 10 .
  • Figure 4 is a schematic diagram of the failure of the mitral valve to close properly during the systolic phase;
  • Figure 5 is a valve repair device of this embodiment implanted at the mitral valve in Figure 4 to close the two leaflets 1 schematic diagram.
  • the drive shaft 20 is screwed to the fixed seat 10 first and locked on the fixed seat 10.
  • the clamping structure 30 remains in a folded state, and the valve repair device in this state is pushed to the patient's mitral valve by the delivery device, and then controlled
  • the drive shaft 20 rotates relative to the fixed seat 10, so that the drive shaft 20 moves along the axial direction of the fixed seat 10, and at the same time drives the clamping structure 30 to rotate and unfold in a direction away from the fixed seat 10, and adjusts the valve repair device to a suitable position, so that
  • the clamping structure 30 supports the leaflet 1, and then controls the drive shaft 20 to move in the opposite direction along the axial direction of the fixed seat 10, and at the same time drives the clamping structure 30 to rotate toward the direction close to the fixed seat 10 to draw in, so that the leaflets on both sides 1.
  • the driving shaft 20 is threadedly connected with the fixing base 10 again and locked on the fixing base 10.
  • the clamping structure 20 remains in a folded state, so as to realize the proper closure of the mitral valve. Avoid reverse flow of blood from the left ventricle into the left atrium.
  • this embodiment can realize the stepless locking function through the screw connection of the fixing seat 10 and the driving shaft 20, that is, in Any part of the threaded connection between the fixing base 10 and the drive shaft 20 can be locked.
  • the drive shaft 20 not only realizes the driving function, drives the clamping structure 30 to open or close, but also cooperates with the fixing seat 10 to realize the locking function.
  • the structure is simple, the locking operation is continuous and uninterrupted, and the operation is easy.
  • the fixing seat 10 is provided with a through hole
  • the inner wall of the through hole is provided with a first thread (not shown in the figure)
  • the driving shaft 20 is provided with a second thread 210
  • the driving shaft 20 is passed through the through hole.
  • the drive shaft 20 can drive the clamping structure 30 to rotate by moving up and down, and the drive shaft 20 can be locked to the fixed seat 10 through the cooperation of the first thread and the second thread 210 .
  • the second thread 210 on the drive shaft 20 and the first thread on the inner wall of the through hole engage with each other, so that the drive shaft 20 stays at the current position and remains motionless relative to the fixed seat 10, and at the same time, the clamping structure is locked on the drive shaft 20.
  • fixing the seat 10 correspondingly keep the current open or folded state unchanged.
  • the drive shaft 20 When in use, the drive shaft 20 is firstly locked on the fixing base 10 through the cooperation of the first thread and the second thread 210. At this time, the clamping structure 30 remains in a folded state, and the valve repair device in this state is pushed to the patient's body by the delivery device.
  • the drive shaft 20 At the mitral valve, then control the drive shaft 20 to rotate relative to the first thread of the fixed seat 10 through the second thread 210, so that the drive shaft 20 moves along the axial direction of the fixed seat 10, and at the same time drives the clamping structure 30 to expand to repair the valve
  • the device is adjusted to a proper position, so that the clamping structure 30 holds the leaflet 1, and then the driving shaft 20 is controlled to move in the opposite direction along the axial direction of the fixing seat 10, and at the same time, the clamping structure 30 is driven to close, so that the leaflets 1 on both sides are Under the action of the clamping structure 30, the drive shaft 20 is locked on the fixing seat 10 through the cooperation of the first thread and the second thread 210 again.
  • the clamping structure 30 remains in a folded state, so as to realize the proper closure of the mitral valve , to avoid reverse flow of blood from the left ventricle into the left atrium.
  • the delivery device includes a driving part, which is detachably connected with the driving shaft 20 of the valve repair device, and the driving part is used to control the axial movement of the driving shaft 20 .
  • the driving part controls the rotation of the drive shaft 20 outside the body, so that the drive shaft 20 rises or falls along its axial direction.
  • the drive shaft 20 due to the cooperation of the first thread and the second thread 210, when the drive part stops rotating, the drive shaft 20 to achieve locking relative to the fixed seat 10.
  • the drive member and the drive shaft 20 are detachably connected using non-threaded structures such as shaft hole structures and jaw structures, so as to prevent the two from loosening during the linkage process of the drive member controlling the drive shaft 20 or causing the drive to exit during the process of exiting the drive member.
  • the shaft 20 moves again; in other embodiments, the drive shaft 20 and the drive member are detachably connected using a screw structure with a specification different from the first thread and the second thread 210. 20 misuse.
  • the valve repair device further includes a connection base 40 , the drive shaft 20 is connected to the connection base 40 , and the drive shaft 20 can rotate relative to the connection base 40 and can be linked with the connection base 40 .
  • Linkage means that the connecting seat 40 and the driving shaft 20 move up and down synchronously, so that when the driving shaft 20 rotates relative to the fixed seat 10 and moves axially, the connecting seat 40 is driven by the driving shaft 20 along the axial direction of the driving shaft 20. Or away from the fixed seat 10.
  • the clamping structure 30 is rotatably connected to the drive shaft 20 through the connecting seat 40 .
  • connection seat 40 and the drive shaft 20 can rotate relative to the connection seat 40 through the bearing, without affecting the rotation of the second thread 210 of the drive shaft 20 in cooperation with the first thread, and the drive shaft 20
  • the movement along the axial direction during the rotation can synchronously drive the connecting seat 40 to move relative to the fixed seat 10 , and then use the relative movement between the connecting seat 40 and the fixed seat 10 to drive the clamping structure 30 to rotate to switch between the opened and folded states.
  • the connection base 40 and the drive shaft 20 can also be rotatably connected through other structures, which not only satisfy the rotation of the drive shaft 20 but also realize the linkage between the drive shaft 20 and the connection base 40 .
  • an annular groove is set in the connection seat 40, and a protrusion matching the groove is set on the drive shaft 20, so that the drive shaft 20 is stuck in the groove through the protrusion, and the protrusion Can rotate in the groove.
  • a through hole is provided on the connection base 40, and one end of the drive shaft 20 passes through the through hole, and a protrusion is provided at the end of the drive shaft 20 protruding from the through hole so that the drive shaft 20 is limited to the connection base 40, and the drive shaft 20 can be positioned at the same time. Rotate through the hole.
  • the nominal diameter of the second thread 210 is 0.2mm ⁇ 5mm.
  • the nominal diameter of the second screw thread 210 is 1mm, 2mm or 3mm.
  • the specification of the first thread is the same as that of the second thread 210 .
  • the parameters of the second thread 210 and the first thread can be adjusted according to actual needs.
  • the number of turns of the first thread is 3 to 5 turns, so that there is a certain locking force between the driving shaft 20 and the fixing seat 10 .
  • valve repair device will be further described in conjunction with the structure of the clamping structure 30 below.
  • the clamping structure 30 in one embodiment includes a first clamping arm 310a, a second clamping arm 320a, a first transmission arm 330a and a second transmission arm 340a.
  • One end of the first transmission arm 330a is rotatably connected with the connection base 40
  • the other end of the first transmission arm 330a is rotatably connected with the first clamping arm 310a
  • one end of the second transmission arm 340a is rotatably connected with the connection base 40.
  • the other end of 340a is rotatably connected to the second clamping arm 320a , the first clamping arm 310a is rotatably connected to the fixing base 10 , and the second clamping arm 320a is rotatably connected to the fixing base 10 .
  • the first transmission arm 330a and the second transmission arm 340a are respectively arranged on both sides of the connection base 40, the first transmission arm 330a is located outside the first clamping arm 310a, and the second transmission arm 340a is located outside the second clamping arm 320a .
  • the first clamping arm 310 a , the second clamping arm 320 a , the first transmission arm 330 a , and the second transmission arm 340 a are attached to two sides of the driving shaft 20 .
  • the drive shaft 20 moves downward, driving the connecting seat 40 to move down, synchronously driving the first transmission arm 330a and the second transmission arm 340a to open in a direction away from the drive shaft 20, and then driving the first clamping arm 310a and the second clamping arm 310a respectively
  • the arm 320a opens in a direction away from the drive shaft 20; the drive shaft 20 moves upward, driving the connecting seat 40 to move upward, synchronously driving the first transmission arm 330a and the second transmission arm 340a to close to the direction of the drive shaft 20, and then respectively driving the first transmission arm 330a and the second transmission arm 340a
  • the first clamping arm 310 a and the second clamping arm 320 a are retracted towards the direction close to the driving shaft 20 .
  • first transmission arm 330a and the second transmission arm 340a When the first transmission arm 330a and the second transmission arm 340a are opened or folded, they rotate around the rotating shaft on the connecting base 40 .
  • first clamping arm 310 a and the second clamping arm 320 a When the first clamping arm 310 a and the second clamping arm 320 a are opened or folded, they rotate around the rotation axis on the fixing base 10 .
  • the entire section of the drive shaft 20 shown in this embodiment (except the part that cooperates with the drive member) is provided with a second screw thread 210, so that the drive shaft 20 can move axially to any position through the second screw thread 210.
  • the second thread 210 cooperates with the first thread to lock on the fixing base 10 .
  • the second thread 210 is disposed on the lower section of the drive shaft 20 .
  • the fixing seat 10 is correspondingly arranged at a position close to the connecting seat 40 .
  • the second thread 210 is disposed on the lower section and the middle section of the driving shaft 20 .
  • the second screw thread 210 is set to cooperate with the first screw thread of the fixing seat 10 in the area where fine control is required (for example, near the final clamping position and the observation state stage), so as to realize fine control, while the second screw thread 210 is not set in other areas,
  • the driving shaft 20 can move rapidly along the axial direction, and the overall operation time is shortened.
  • the axial direction of the drive shaft 20 is defined as a first direction, and the direction perpendicular to the first direction is defined as a second direction.
  • the drive shaft 20 rotates around the first direction through the cooperation of the second thread 210 and the first thread, and moves up and down synchronously.
  • the drive shaft 20 stops rotating and can be locked to the fixed seat 10;
  • the drive shaft 20 can directly move up and down along the first direction, so as to increase the moving speed and reduce the operation time.
  • the driving clamping structure 30 rotates around the second direction, away from or close to the driving shaft 20 .
  • the first transmission arm 330 a and the second transmission arm 340 a shown in FIG. 1 are rotatably connected to the connection base 40 through a rotating shaft perpendicular to the drive shaft 20 .
  • the first clamping arm 310 a and the second clamping arm 320 a are respectively rotatably connected to the fixing base 10 through a rotating shaft perpendicular to the driving shaft 20 .
  • the ends of the first transmission arm 330a and the second transmission arm 340a away from the connection base 40 are respectively rotatably connected to the outer sides of the first clamping arm 310a and the second clamping arm 320a through a rotating shaft perpendicular to the drive shaft 20 .
  • the clamping structure 30 also includes a third clamping arm 350a and a fourth clamping arm 360a, the third clamping arm 350a is connected to the fixing base 10, and the fourth clamping arm 360a is connected to the fixing base 10. 10 connection, the third clamping arm 350a cooperates with the first clamping arm 310a, and the fourth clamping arm 360a cooperates with the second clamping arm 320a.
  • the third clamping arm 350a and the fourth clamping arm 360a can be made of memory material and fixed on the fixing base, or the third clamping arm 350a and the fourth clamping arm 360a are respectively connected to the fixing base 10 through a torsion spring and a rotating shaft.
  • the third clamping arm 350a presses against the first clamping arm 310a
  • the fourth clamping arm 360a presses against the second clamping arm 320a.
  • the third clamping arm 350a and the fourth clamping arm 360a are controlled by operating wires outside the body, and the ends of the third clamping arm 350a and the fourth clamping arm 360a near the upper section of the drive shaft 20 are provided with control holes through which the operating wires pass In the control hole, during the push-in process, the operating wire controls the third clamping arm 350a and the fourth clamping arm 360a to be close to the drive shaft 20. After pushing in place, the operating wire is released to make the third clamping arm 350a press against the first clamping arm 350a.
  • the clamping arm 310a, the third clamping arm 350a cooperates with the first clamping arm 310a to clamp the leaflet 1 on one side
  • the fourth clamping arm 360a presses against the second clamping arm 320a
  • the second clamping arm 320a cooperates to clamp the valve leaflet 1 on the other side, and then controls the drive shaft 20 to move upward, so that the third clamping arm 350a, the first clamping arm 310a and the valve leaflet 1 clamped by them approach each other.
  • the fourth clamping arm 360a, the second clamping arm 320a and the leaflet 1 between them rotate in a direction close to the drive shaft 20, so that the two leaflets 1 are combined together, To achieve the purpose of preventing blood backflow.
  • the first clamping arm 310a and the second clamping arm 320a are located in the ventricle to support the leaflet 1
  • the third clamping arm 350a and the fourth clamping arm 360a are located in the atrium to support the leaflet 1.
  • the third clamping arm 350a is provided with a barb 301 on the side facing the first clamping arm 310a
  • the fourth clamping arm 360a is provided with a barb on the side facing the second clamping arm 320a. Thorn 301.
  • the barb 301 increases the clamping force between the third clamping arm 350a and the first clamping arm 310a, and between the fourth clamping arm 360a and the second clamping arm 320a, so as to prevent the leaflet 1 from slipping out.
  • the clamping structure 30 includes a first clamping arm 310b, a second clamping arm 320b, a first transmission arm 330b and a second transmission arm 340b.
  • One end of the first transmission arm 330b is rotatably connected with the fixed seat 10
  • the other end of the first transmission arm 330b is rotatably connected with the first clamping arm 310b
  • one end of the second transmission arm 340b is rotatably connected with the fixed seat 10.
  • the other end of 340b is rotatably connected to the second clamping arm 320b , the first clamping arm 310b is rotatably connected to the connecting seat 40 , and the second clamping arm 320b is rotatably connected to the connecting seat 40 .
  • the first clamping arm 310b and the second clamping arm 320b are respectively arranged on both sides of the connecting seat 40, the first transmission arm 330b is located inside the first clamping arm 310b, and the second transmission arm 340b is located on the second clamping arm 320b. inside.
  • the first clamping arm 310b, the second clamping arm 320b, the first transmission arm 330b, and the second transmission arm 340b are attached to two sides of the driving shaft 20 respectively.
  • the driving shaft 20 moves upwards, driving the connecting seat 40 to move upwards, synchronously driving the first transmission arm 330b and the second transmission arm 340b to open in a direction away from the driving shaft 20, and then respectively driving the first clamping arm 310b and the second clamping arm 320b opens in a direction away from the drive shaft 20;
  • the drive shaft 20 moves downward, driving the connecting seat 40 to move down, synchronously driving the first transmission arm 330a and the second transmission arm 340a to close to the direction of the drive shaft 20, and then respectively driving the first transmission arm 330a and the second transmission arm 340a
  • the first clamping arm 310b and the second clamping arm 320b converge towards the direction close to the driving shaft 20 .
  • first transmission arm 330b and the second transmission arm 340b When the first transmission arm 330b and the second transmission arm 340b are opened or folded, they rotate around the rotation axis on the fixing base 10 .
  • first clamping arm 310b and the second clamping arm 320b When the first clamping arm 310b and the second clamping arm 320b are opened or folded, they rotate around the rotating shaft on the connecting seat 40 .
  • the fixing base 10 shown in this embodiment is disposed at a position away from the connecting base 40 .
  • the upper section of the drive shaft 20 is provided with the second thread 210 or the upper section and the middle section of the drive shaft 20 are provided with the second thread 210 .
  • the second screw thread 210 is set to cooperate with the first screw thread of the fixing seat 10 in the area where fine control is required (for example, near the final clamping position and the observation state stage), so as to realize fine control, while the second screw thread 210 is not set in other areas,
  • the driving shaft 20 can move rapidly along the axial direction, and the overall operation time is shortened.
  • the second screw thread 210 can also be provided on the entire section of the drive shaft 20 (except the part that cooperates with the driver), so that the drive shaft 20 can move axially to any position through the second screw thread 210 and the first screw thread.
  • the thread fits and locks on the fixing seat 10 .
  • the axial direction of the drive shaft 20 is defined as the first direction, and the direction perpendicular to the first direction is defined as the second direction.
  • the drive shaft 20 rotates around the first direction through the cooperation of the second thread 210 and the first thread, and moves up and down synchronously.
  • the drive shaft 20 stops rotating and can be locked to the fixed seat 10;
  • the drive shaft 20 can directly move up and down along the first direction, so as to increase the moving speed and reduce the operation time.
  • the driving clamping structure 30 rotates around the second direction, away from or close to the driving shaft 20 .
  • the first transmission arm 330b and the second transmission arm 340b shown in FIG. 3 are rotatably connected to the fixed base 10 through a rotating shaft perpendicular to the drive shaft 20 .
  • the first clamping arm 310 and the second clamping arm 320 b are respectively rotatably connected to the connection base 10 through a rotating shaft perpendicular to the drive shaft 20 .
  • the ends of the first transmission arm 330b and the second transmission arm 340ba away from the fixed base 10 are respectively connected to the inner sides of the first clamping arm 310b and the second clamping arm 320b through a rotating shaft perpendicular to the drive shaft 20 .
  • the clamping structure 30 further includes a third clamping arm 350b and a fourth clamping arm 360b, the third clamping arm 350b is connected to the first transmission arm 330b or the fixed seat 10, and the fourth clamping arm 360b is connected to the second transmission arm 340b or the fixing base 10, the third clamping arm 350b is matched with the first clamping arm 310b, and the fourth clamping arm 360b is matched with the second clamping arm 340b.
  • the third clamping arm 350b and the fourth clamping arm 360b can be made of memory material and fixed on the first transmission arm 330b, the second transmission arm 340b or the fixing seat 10, or the third clamping arm 350b, the fourth clamping arm 360b is connected to the first transmission arm 330b, the second transmission arm 340b or the fixing seat 10 through a torsion spring and a rotating shaft respectively.
  • the third clamping arm 350b presses against the first clamping arm 310b
  • the fourth clamping arm 360b presses against the second clamping arm 320b.
  • the third clamping arm 350b and the fourth clamping arm 360b are controlled by operating wires outside the body, and the ends of the third clamping arm 350b and the fourth clamping arm 360b near the upper section of the drive shaft 20 are provided with control holes through which the operating wires pass In the control hole, during the push-in process, the operating wire controls the third clamping arm 350b and the fourth clamping arm 360b to be close to the drive shaft 20. After pushing in place, the operating wire is released to make the third clamping arm 350b press against the first clamping arm 350b.
  • the clamping arm 310b, the third clamping arm 350b cooperates with the first clamping arm 310b to clamp the leaflet 1 on one side
  • the fourth clamping arm 360b presses against the second clamping arm 320b
  • the second clamping arm 320b cooperates to clamp the valve leaflet 1 on the other side, and then controls the drive shaft 20 to move downward, so that the third clamping arm 350b, the first clamping arm 310b and the valve leaflet 1 clamped by them are in the same direction.
  • the fourth clamping arm 360b, the second clamping arm 320b and the leaflet 1 between them rotate in a direction close to the drive shaft 20, so that the two leaflets 1 are combined together , to avoid the purpose of blood backflow.
  • the first clamping arm 310b and the second clamping arm 320b are located in the ventricle to support the valve leaflet 1
  • the third clamping arm 350b and the fourth clamping arm 360b are located in the atrium to support the valve leaflet 1 .
  • the third clamping arm 350b is provided with barbs 301 on the side facing the first clamping arm 310b
  • the fourth clamping arm 360b is provided with barbs 301 on the side facing the second clamping arm 320b.
  • the barb 301 increases the clamping force between the third clamping arm 350b and the first clamping arm 310b, and between the fourth clamping arm 360b and the second clamping arm 320b, so as to prevent the leaflet 1 from slipping out.
  • the length of the shaft section with the second thread 210 on the drive shaft 20 is L1
  • the length of the first clamping arm or the second clamping arm is L2, 0:1 ⁇ L1: L2 ⁇ 2:1.
  • L1:L2 is 0.5:1, 1:1 or 1.5:1, etc.

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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

本申请涉及一种瓣膜修复装置及瓣膜修复***，瓣膜修复装置包括固定座(10)、驱动轴(20)及夹持结构(30)，夹持结构(30)与固定座(10)转动连接，驱动轴(20)与固定座(10)螺纹连接，驱动轴(20)能相对固定座(10)上下移动以驱动夹持结构(30)朝靠近或远离固定座(10)的方向转动。

Description

瓣膜修复装置及瓣膜修复***
本申请要求于2021年12月22日申请的，申请号为2021115830005、名称为“瓣膜修复装置及瓣膜修复***”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本申请涉及医疗器械技术领域，特别是涉及一种瓣膜修复装置及瓣膜修复***。
背景技术
随着社会经济的发展和人口老龄化的加重，老年性瓣膜病以及冠心病、心肌梗死后引起的瓣膜病变也越来越常见。以二尖瓣为例，人体的心脏分为左心房、左心室和右心房、右心室四个心腔，两个心房分别和两个心室相连，两个心室和两个大动脉相连。二尖瓣生长在左心房和左心室之间，由瓣叶、瓣环、腱索和***肌组成，起到单向阀门的作用，保证血流仅允许从左心房向左心室单方向运动。二尖瓣反流是最为常见的二尖瓣疾病之一，其是指当在心脏收缩阶段期间，二尖瓣膜未能恰当地闭合，血液从左心室反向流入左心房。为治疗二尖瓣反流疾病，通常采用二尖瓣修复装置。
二尖瓣修复装置是一种可植入式假体，一般包括驱动杆、传动臂、固定点、夹取机构和锁止机构，固定点固定不动，驱动杆滑动穿设于固定点中间，驱动杆上下滑动带动夹取机构运动，由夹取机构夹取瓣叶将两瓣叶固定到一起，以减少血液反流。传统的二尖瓣修复装置，驱动杆配合锁止机构实现锁止功能，其锁止 位置由驱动杆的长度、配合锁止机构的设置所决定，需要驱动杆到达适当位置的时候，手动操作控制锁止机构将驱动杆锁止，这种锁止过程往往是间断的，而且锁止机构结构复杂，操作繁琐。
发明内容
根据本申请的各种实施例，提供一种瓣膜修复装置及瓣膜修复***。
一方面，本申请提供一种瓣膜修复装置，包括固定座、驱动轴及夹持结构，所述夹持结构与所述固定座转动连接，所述驱动轴与所述固定座螺纹连接，所述驱动轴能相对所述固定座上下移动以驱动所述夹持结构朝靠近或远离固定座的方向转动。
另一方面，本申请提供一种瓣膜修复装置，包括固定座、驱动轴及夹持结构，所述夹持结构与所述固定座转动连接，所述驱动轴与所述固定座螺纹连接，所述夹持结构与所述驱动轴驱动连接，当所述驱动轴相对所述固定座转动时，所述驱动轴相对所述固定座移动并带动所述夹持结构朝靠近或远离固定座的方向转动。
再一方面，本申请提供一种瓣膜修复***，包括上述的瓣膜修复装置及输送装置，所述输送装置包括驱动件，所述驱动件与所述驱动轴可拆卸连接，所述驱动件用于驱使所述驱动轴相对所述固定座转动。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他实施例的附图。
图1为本申请一实施例的瓣膜修复装置的示意图；
图2为本申请又一实施例的瓣膜修复装置的示意图；
图3为本申请另一实施例的瓣膜修复装置的示意图；
图4为未植入瓣膜修复装置的心脏示意图；
图5为植入本申请一实施例的瓣膜修复装置的心脏示意图。
附图标号说明：
1、瓣叶；10、固定座；20、驱动轴；210、第二螺纹；30、夹持结构；301、倒刺；310a、第一夹持臂；320a、第二夹持臂；330a、第一传动臂；340a、第二传动臂；350a、第三夹持臂；360a、第四夹持臂；310b、第一夹持臂；320b、第二夹持臂；330b、第一传动臂；340b、第二传动臂；350b、第三夹持臂；360b、第四夹持臂；40、连接座。
具体实施方式
为了便于理解本申请，下面将参照相关附图对本申请进行更全面的描述。附图中给出了本申请的首选实施例。但是，本申请可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本申请的公开内容更加透彻全面。
在本申请的描述中，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本申请的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
在本申请中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、 “固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。
本申请一实施例提供一种瓣膜修复***，包括瓣膜修复装置及与输送装置。瓣膜修复装置通过输送装置推送至患者体内。可选地，瓣膜修复装置采用可植入的金属材料，例如钛合金、钴铬合金等；或者采用可植入的高分子材料，例如PLA等。操作者通过输送装置将瓣膜修复装置由患者体外推送至患者体内，为方便描述，下文中提到的上、下方位分别是指：靠近操作者的方向为上，远离操作者的方向为下。
参阅图1，在其中一实施例中，瓣膜修复装置包括固定座10、驱动轴20及夹持结构30。夹持结构30与固定座10转动连接。驱动轴20与固定座10螺纹连接，由此，驱动轴20相对固定座10转动时，在这种螺纹配合的作用下，驱动轴20沿轴向(即驱动轴20的长度方向)相对固定座10移动。另外，基于螺纹本身具有自锁性能，驱动轴20与固定座10螺纹连接，即意味着，只有当驱动轴20与固定座10相对转动时，驱动轴20与固定座10之间才会出现轴向上的相对位移，换言之，在驱动轴20与固定座10彼此未产生相对转动时，固定座10与驱动轴20沿轴向保持相对静止，继而达到固定座10沿轴向锁止于驱动轴20的效果。夹持结构30与驱动轴20驱动连接。驱动轴20能相对所述固定座10 上下移动以驱动夹持结构30朝靠近或远离固定座10的方向转动。
参照图4、5，图4为心脏收缩阶段期间二尖瓣膜未能恰当地闭合的示意图；图5为将本实施例的瓣膜修复装置植入图4中二尖瓣膜处使两瓣叶1闭合的示意图。驱动轴20先与固定座10螺纹连接锁止于固定座10上，此时夹持结构30保持收拢状态，通过输送装置将该状态下的瓣膜修复装置推送至患者的二尖瓣处，然后控制驱动轴20相对固定座10转动，使驱动轴20沿固定座10的轴向方向移动，同时带动夹持结构30朝远离固定座10的方向转动而展开，将瓣膜修复装置调整至合适位置，使夹持结构30托住瓣叶1，再控制驱动轴20沿固定座10的轴向方向反向移动，同时带动夹持结构30朝靠近固定座10的方向转动而收拢，使两侧的瓣叶1在夹持结构30的作用下对合，驱动轴20再次与固定座10螺纹连接而锁止于固定座10上，此时夹持结构20保持收拢状态，从而实现二尖瓣膜恰当地闭合，避免血液从左心室反向流入左心房。相比传统通过额外设置锁止弹片及锁紧件等锁止结构与驱动杆配合实现锁止的方式，本实施例通过固定座10与驱动轴20螺纹连接能实现无级锁止功能，即在固定座10与驱动轴20螺纹连接的任一部位均可实现锁止。通过驱动轴20既实现驱动功能，带动夹持结构30打开或者收拢，又能配合固定座10实现锁止功能，结构简单，锁止操作连续不间断，操作简便。
进一步地，一实施例中，固定座10设有通孔，通孔内壁设有第一螺纹(图中未示出)，驱动轴20上设有第二螺纹210，驱动轴20穿设于通孔内且能沿所述通孔上下移动，所述驱动轴20上下移动能驱动夹持结构30转动，且驱动轴20通过第一螺纹与第二螺纹210配合能锁止于固定座10。即驱动轴20上的第二螺纹210与通孔内壁上的第一螺纹相互咬合，使驱动轴20停留在当前位置相对固定座10保持不动，同时使夹持结构在驱动轴20锁止于固定座10时，对应 地保持当前打开或者收拢状态不变。
使用时，驱动轴20先通过第一螺纹与第二螺纹210配合锁止在固定座10上，此时夹持结构30保持收拢状态，通过输送装置将该状态下的瓣膜修复装置推送至患者的二尖瓣处，然后控制驱动轴20通过第二螺纹210相对固定座10的第一螺纹转动，使驱动轴20沿固定座10的轴向方向移动，同时带动夹持结构30展开，将瓣膜修复装置调整至合适位置，使夹持结构30托住瓣叶1，再控制驱动轴20沿固定座10的轴向方向反向移动，同时带动夹持结构30收拢，使两侧的瓣叶1在夹持结构30的作用下对合，驱动轴20再次通过第一螺纹与第二螺纹210配合锁止在固定座10上，此时夹持结构30保持收拢状态，从而实现二尖瓣膜恰当地闭合，避免血液从左心室反向流入左心房。
进一步地，输送装置包括驱动件，驱动件与瓣膜修复装置的驱动轴20可拆卸连接，驱动件用于控制驱动轴20沿其轴向移动。驱动件在体外控制驱动轴20转动，使驱动轴20沿其轴向上升或下降，驱动轴20移动过程中，由于第一螺纹与第二螺纹210配合，从而在驱动件停止转动时，驱动轴20即可实现相对固定座10锁止。可选地，驱动件与驱动轴20采用如轴孔结构、夹爪结构等非螺纹结构实现可拆卸连接，避免驱动件控制驱动轴20联动过程中两者松脱或者退出驱动件过程中使驱动轴20再次移动；在其他实施例中，驱动轴20与驱动件采用规格不同于第一螺纹与第二螺纹210的螺纹结构实现可拆卸连接，两者实现快速装配与分离，同时避免对驱动轴20的误操作。
参照图1、2，在其中一实施例中，瓣膜修复装置还包括连接座40，驱动轴20与连接座40连接，驱动轴20能相对连接座40转动且能与连接座40联动。联动是指连接座40与驱动轴20同步上下移动，这样，在驱动轴20相对固定座10转动而沿轴向移动时，连接座40在驱动轴20的带动下沿驱动轴20的轴向靠 近或远离固定座10。夹持结构30通过连接座40与驱动轴20转动连接。可选地，连接座40与驱动轴20之间设有轴承，驱动轴20通过轴承可相对连接座40转动，不影响驱动轴20的第二螺纹210与第一螺纹配合转动，而且驱动轴20转动过程中沿轴向移动能同步带动连接座40相对固定座10移动，进而利用连接座40与固定座10的相对运动来带动夹持结构30转动实现打开或者收拢状态的切换。在其他实施例中，连接座40与驱动轴20之间还可通过其他结构转动连接，既满足驱动轴20的转动，又能实现驱动轴20与连接座40之间联动。如：在连接座40内设置环形的凹槽，在驱动轴20上设置与凹槽配合的凸起，使驱动轴20通过凸起卡在凹槽内，并且驱动轴20转动过程中，凸起能在凹槽内转动。或者，连接座40上开设贯穿孔，驱动轴20的一端穿过贯穿孔，并在驱动轴20伸出贯穿孔的一端设置凸起使驱动轴20限位于连接座40，同时驱动轴20能在贯穿孔内转动。
可选地，第二螺纹210的公称直径为0.2mm～5mm。如第二螺纹210的公称直径为1mm、2mm或3mm等。第一螺纹的规格与第二螺纹210相同。可根据实际需求调整第二螺纹210与第一螺纹的参数。可选地，第一螺纹的螺纹圈数为3圈～5圈，使驱动轴20与固定座10之间具有一定的锁紧力。
关于利用连接座40与固定座10的相对运动来带动夹持结构30转动实现打开或者收拢状态的切换，下面将结合夹持结构30的结构对瓣膜修复装置做进一步说明。
参照图1、2，一实施例中夹持结构30包括第一夹持臂310a、第二夹持臂320a、第一传动臂330a及第二传动臂340a。第一传动臂330a的一端与连接座40转动连接，第一传动臂330a的另一端与第一夹持臂310a转动连接，第二传动臂340a的一端与连接座40转动连接，第二传动臂340a的另一端与第二夹持 臂320a转动连接，第一夹持臂310a与固定座10转动连接，第二夹持臂320a与固定座10转动连接。第一传动臂330a与第二传动臂340a分别设置在连接座40的两侧，第一传动臂330a位于第一夹持臂310a的外侧，第二传动臂340a位于第二夹持臂320a的外侧。收拢状态下，第一夹持臂310a、第二夹持臂320a第一传动臂330a、第二传动臂340a分别贴设于驱动轴20的两侧。驱动轴20向下移动，带动连接座40下移，同步带动第一传动臂330a与第二传动臂340a向远离驱动轴20的方向打开，进而分别带动第一夹持臂310a、第二夹持臂320a向远离驱动轴20的方向打开；驱动轴20向上移动，带动连接座40上移，同步带动第一传动臂330a与第二传动臂340a向靠近驱动轴20的方向收拢，进而分别带动第一夹持臂310a、第二夹持臂320a向靠近驱动轴20的方向收拢。第一传动臂330a、第二传动臂340a打开或收拢过程中，绕连接座40上的转轴转动。第一夹持臂310a、第二夹持臂320a打开或收拢过程中，绕固定座10上的转轴转动。
可选地，如图1所示，本实施例示出的驱动轴20整段(除与驱动件配合部分)设有第二螺纹210，使驱动轴20轴向移动到任一位置均能通过第二螺纹210与第一螺纹配合锁止在固定座10上。参照图2，在其它实施例中，第二螺纹210设置于驱动轴20的下段。固定座10对应设置在靠近连接座40的位置。或者，另一实施例中，第二螺纹210设置于驱动轴20的下段与中段。在需要精细控制的区域(例如最终夹持位置附近和观察状态阶段)设置第二螺纹210与固定座10的第一螺纹配合，以实现精细控制，而在其他区域则不设置第二螺纹210，使驱动轴20能快速沿轴向移动，减短整体操作时间。
参照图1，以驱动轴20的轴向方向为第一方向，垂直于第一方向的方向为第二方向。在具有第二螺纹210的轴段，驱动轴20通过第二螺纹210与第一螺 纹配合绕第一方向转动，同步实现上下移动，驱动轴20停止转动即可锁止于固定座10；在没有第二螺纹210的轴段，驱动轴20可沿第一方向直接上下移动，提高移动速度，减少操作时间。驱动轴20上下移动过程中，驱动夹持结构30绕第二方向转动，远离或者靠近驱动轴20。图1中示出的第一传动臂330a与第二传动臂340a分别通过一垂直驱动轴20的转轴与连接座40转动连接。第一夹持臂310a、第二夹持臂320a分别通过一垂直驱动轴20的转轴与固定座10转动连接。第一传动臂330a、第二传动臂340a远离连接座40的一端分别通过一垂直驱动轴20的转轴与第一夹持臂310a、第二夹持臂320a的外侧转动连接。
进一步地，参照图1、2，夹持结构30还包括第三夹持臂350a与第四夹持臂360a，第三夹持臂350a与固定座10连接，第四夹持臂360a与固定座10连接，第三夹持臂350a与第一夹持臂310a配合，第四夹持臂360a与第二夹持臂320a配合。第三夹持臂350a与第四夹持臂360a可采用记忆材料制作固设于固定座，或者第三夹持臂350a、第四夹持臂360a分别通过扭簧及转轴与固定座10连接。自然状态下，第三夹持臂350a压向第一夹持臂310a，第四夹持臂360a压向第二夹持臂320a。第三夹持臂350a与第四夹持臂360a通过体外的操作丝进行控制，第三夹持臂350a与第四夹持臂360a靠近驱动轴20上段的一端设有控制孔，操作丝穿设于控制孔，推入过程中，操作丝控制第三夹持臂350a与第四夹持臂360a贴近驱动轴20，推送到位后，松开操作丝，使第三夹持臂350a压向第一夹持臂310a，第三夹持臂350a与第一夹持臂310a配合夹紧一侧的瓣叶1，第四夹持臂360a压向第二夹持臂320a，第四夹持臂360a与第二夹持臂320a配合夹紧另一侧的瓣叶1，再控制驱动轴20向上移动，使第三夹持臂350a、第一夹持臂310a及两者夹持的瓣叶1向靠近驱动轴20的方向转动，第四夹持臂360a、第二夹持臂320a及两者之间瓣叶1向靠近驱动轴20的方向转动，从 而使两个的瓣叶1对合在一起，达到避免血液倒流的目的。其中，第一夹持臂310a、第二夹持臂320a位于心室内托住瓣叶1，第三夹持臂350a与第四夹持臂360a位于心房内托住瓣叶1。
进一步地，参照图1、2，第三夹持臂350a朝向第一夹持臂310a的一侧设有倒刺301，第四夹持臂360a朝向第二夹持臂320a的一侧设有倒刺301。通过倒刺301增加第三夹持臂350a与第一夹持臂310a之间、第四夹持臂360a与第二夹持臂320a之间的夹持力，避免瓣叶1滑出。
参照图3，另一实施例中夹持结构30包括第一夹持臂310b、第二夹持臂320b、第一传动臂330b及第二传动臂340b。第一传动臂330b的一端与固定座10转动连接，第一传动臂330b的另一端与第一夹持臂310b转动连接，第二传动臂340b的一端与固定座10转动连接，第二传动臂340b的另一端与第二夹持臂320b转动连接，第一夹持臂310b与连接座40转动连接，第二夹持臂320b与连接座40转动连接。第一夹持臂310b与第二夹持臂320b分别设置在连接座40的两侧，第一传动臂330b位于第一夹持臂310b的内侧，第二传动臂340b位于第二夹持臂320b的内侧。收拢状态下，第一夹持臂310b、第二夹持臂320b第一传动臂330b、第二传动臂340b分别贴设于驱动轴20的两侧。驱动轴20向上移动，带动连接座40上移，同步带动第一传动臂330b与第二传动臂340b向远离驱动轴20的方向打开，进而分别带动第一夹持臂310b、第二夹持臂320b向远离驱动轴20的方向打开；驱动轴20向下移动，带动连接座40下移，同步带动第一传动臂330a与第二传动臂340a向靠近驱动轴20的方向收拢，进而分别带动第一夹持臂310b、第二夹持臂320b向靠近驱动轴20的方向收拢。第一传动臂330b、第二传动臂340b打开或收拢过程中，绕固定座10上的转轴转动。第一夹持臂310b、第二夹持臂320b打开或收拢过程中，绕连接座40上的转轴 转动。
参照图3，本实施例示出的固定座10设置于远离连接座40的位置。对应地，驱动轴20上段设有第二螺纹210或者驱动轴20上段及中段设有第二螺纹210。在需要精细控制的区域(例如最终夹持位置附近和观察状态阶段)设置第二螺纹210与固定座10的第一螺纹配合，以实现精细控制，而在其他区域则不设置第二螺纹210，使驱动轴20能快速沿轴向移动，减短整体操作时间。在其他实施例中，也可在驱动轴20整段(除与驱动件配合部分)设有第二螺纹210，使驱动轴20轴向移动到任一位置均能通过第二螺纹210与第一螺纹配合锁止在固定座10上。
参照图3，以驱动轴20的轴向方向为第一方向，垂直于第一方向的方向为第二方向。在具有第二螺纹210的轴段，驱动轴20通过第二螺纹210与第一螺纹配合绕第一方向转动，同步实现上下移动，驱动轴20停止转动即可锁止于固定座10；在没有第二螺纹210的轴段，驱动轴20可沿第一方向直接上下移动，提高移动速度，减少操作时间。驱动轴20上下移动过程中，驱动夹持结构30绕第二方向转动，远离或者靠近驱动轴20。图3中示出的第一传动臂330b与第二传动臂340b分别通过一垂直驱动轴20的转轴与固定座10转动连接。第一夹持臂310、第二夹持臂320b分别通过一垂直驱动轴20的转轴与连接座10转动连接。第一传动臂330b、第二传动臂340ba远离固定座10的一端分别通过一垂直驱动轴20的转轴与第一夹持臂310b、第二夹持臂320b的内侧转动连接。
进一步地，参照图3，夹持结构30还包括第三夹持臂350b与第四夹持臂360b，第三夹持臂350b与第一传动臂330b或固定座10连接，第四夹持臂360b与第二传动臂340b或固定座10连接，第三夹持臂350b与第一夹持臂310b配合，第四夹持臂360b与第二夹持臂340b配合。第三夹持臂350b与第四夹持臂 360b可采用记忆材料制作固设于第一传动臂330b、第二传动臂340b或固定座10，或者第三夹持臂350b、第四夹持臂360b分别通过扭簧及转轴与第一传动臂330b、第二传动臂340b或固定座10连接。自然状态下，第三夹持臂350b压向第一夹持臂310b，第四夹持臂360b压向第二夹持臂320b。第三夹持臂350b与第四夹持臂360b通过体外的操作丝进行控制，第三夹持臂350b与第四夹持臂360b靠近驱动轴20上段的一端设有控制孔，操作丝穿设于控制孔，推入过程中，操作丝控制第三夹持臂350b与第四夹持臂360b贴近驱动轴20，推送到位后，松开操作丝，使第三夹持臂350b压向第一夹持臂310b，第三夹持臂350b与第一夹持臂310b配合夹紧一侧的瓣叶1，第四夹持臂360b压向第二夹持臂320b，第四夹持臂360b与第二夹持臂320b配合夹紧另一侧的瓣叶1，再控制驱动轴20向下移动，使第三夹持臂350b、第一夹持臂310b及两者夹持的瓣叶1向靠近驱动轴20的方向转动，第四夹持臂360b、第二夹持臂320b及两者之间瓣叶1向靠近驱动轴20的方向转动，从而使两个的瓣叶1对合在一起，达到避免血液倒流的目的。其中，第一夹持臂310b、第二夹持臂320b位于心室内托住瓣叶1，第三夹持臂350b与第四夹持臂360b位于心房内托住瓣叶1。
进一步地，参照图3，第三夹持臂350b朝向第一夹持臂310b的一侧设有倒刺301，第四夹持臂360b朝向第二夹持臂320b的一侧设有倒刺301。通过倒刺301增加第三夹持臂350b与第一夹持臂310b之间、第四夹持臂360b与第二夹持臂320b之间的夹持力，避免瓣叶1滑出。
可选地，在其中一实施例中，驱动轴20上具有第二螺纹210的轴段的长度为L1，第一夹持臂或第二夹持臂的长度为L2，0:1＜L1:L2≤2:1。如L1:L2为0.5:1、1:1或1.5:1等。
以上实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实 施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (19)

  1. 一种瓣膜修复装置，其特征在于，包括固定座、驱动轴及夹持结构，所述夹持结构与所述固定座转动连接，所述驱动轴与所述固定座螺纹连接，所述驱动轴能相对所述固定座上下移动以驱动所述夹持结构朝靠近或远离固定座的方向转动。
  2. 根据权利要求1所述的瓣膜修复装置，其特征在于，所述固定座设有通孔，所述通孔内壁设有第一螺纹，所述驱动轴上设有第二螺纹，所述驱动轴穿设于所述通孔内且能沿所述通孔上下移动，所述驱动轴通过所述第一螺纹与第二螺纹配合能锁止于所述固定座。
  3. 根据权利要求2所述的瓣膜修复装置，其特征在于，还包括连接座，所述驱动轴与所述连接座连接，所述驱动轴能相对所述连接座转动且能与所述连接座联动；所述夹持结构与所述连接座转动连接。
  4. 根据权利要求3所述的瓣膜修复装置，其特征在于，所述夹持结构包括第一夹持臂、第二夹持臂、第一传动臂及第二传动臂，所述第一传动臂的一端与所述连接座转动连接，所述第一传动臂的另一端与所述第一夹持臂转动连接，所述第二传动臂的一端与所述连接座转动连接，所述第二传动臂的另一端与所述第二夹持臂转动连接，所述第一夹持臂与所述固定座转动连接，所述第二夹持臂与所述固定座转动连接；所述第二螺纹设置于所述驱动轴的下段、或者所述驱动轴的下段与中段、或者所述驱动轴的整段。
  5. 根据权利要求4所述的瓣膜修复装置，其特征在于，所述夹持结构还包括第三夹持臂与第四夹持臂，所述第三夹持臂与所述固定座连接，所述第四夹持臂与所述固定座连接，所述第三夹持臂与所述第一夹持臂夹持配合，所述第四夹持臂与所述第二夹持臂夹持配合。
  6. 根据权利要求3所述的瓣膜修复装置，其特征在于，所述夹持结构包括第一夹持臂、第二夹持臂、第一传动臂及第二传动臂，所述第一传动臂的一端与所述固定座转动连接，所述第一传动臂的另一端与所述第一夹持臂转动连接，所述第二传动臂的一端与所述固定座转动连接，所述第二传动臂的另一端与所述第二夹持臂转动连接，所述第一夹持臂与所述连接座转动连接，所述第二夹持臂与所述连接座转动连接；所述第二螺纹设置于所述驱动轴的上段、或者所述驱动轴的上段及中段、或者所述驱动轴的整段。
  7. 根据权利要求6所述的瓣膜修复装置，其特征在于，所述夹持结构还包括第三夹持臂与第四夹持臂，所述第三夹持臂与所述第一传动臂或所述固定座连接，所述第四夹持臂与所述第二传动臂或所述固定座连接，所述第三夹持臂与所述第一夹持臂夹持配合，所述第四夹持臂与所述第二夹持臂夹持配合。
  8. 根据权利要求5或7所述的瓣膜修复装置，其特征在于，所述第三夹持臂朝向所述第一夹持臂的一侧设有倒刺，所述第四夹持臂朝向所述第二夹持臂的一侧设有倒刺。
  9. 根据权利要求4-7任一项所述的瓣膜修复装置，其特征在于，所述驱动轴上具有所述第二螺纹的轴段的长度为L1，所述第一夹持臂或第二夹持臂的长度为L2，0:1＜L1:L2≤2:1。
  10. 根据权利要求2-7任一项所述的瓣膜修复装置，其特征在于，所述第二螺纹的公称直径为0.2mm～5mm。
  11. 一种瓣膜修复装置，其特征在于，包括固定座、驱动轴及夹持结构，所述夹持结构与所述固定座转动连接，所述驱动轴与所述固定座螺纹连接，所述夹持结构与所述驱动轴驱动连接，当所述驱动轴相对所述固定座转动时，所述驱动轴相对所述固定座移动并带动所述夹持结构朝靠近或远离固定座的方向转动。
  12. 根据权利要求11所述的瓣膜修复装置，其特征在于，还包括连接座，所述驱动轴与所述连接座联动连接，且所述驱动轴能够相对所述连接座转动，所述夹持结构与所述连接座转动连接，当所述驱动轴相对所述固定座转动时，所述驱动轴带动所述连接座靠近或远离所述固定座，使得所述连接座带动所述夹持结构朝靠近或远离固定座的方向转动。
  13. 根据权利要求12所述的瓣膜修复装置，其特征在于，所述夹持结构包括第一夹持臂、第二夹持臂、第一传动臂及第二传动臂，所述第一传动臂的一端与所述连接座转动连接，所述第一传动臂的另一端与所述第一夹持臂转动连接，所述第二传动臂的一端与所述连接座转动连接，所述第二传动臂的另一端与所述第二夹持臂转动连接，所述第一夹持臂与所述固定座转动连接，所述第二夹持臂与所述固定座转动连接。
  14. 根据权利要求13所述的瓣膜修复装置，其特征在于，所述夹持结构还包括第三夹持臂与第四夹持臂，所述第三夹持臂与所述固定座连接，所述第四夹持臂与所述固定座连接，所述第三夹持臂与所述第一夹持臂夹持配合，所述第四夹持臂与所述第二夹持臂夹持配合。
  15. 根据权利要求12所述的瓣膜修复装置，其特征在于，所述夹持结构包括第一夹持臂、第二夹持臂、第一传动臂及第二传动臂，所述第一传动臂的一端与所述固定座转动连接，所述第一传动臂的另一端与所述第一夹持臂转动连接，所述第二传动臂的一端与所述固定座转动连接，所述第二传动臂的另一端与所述第二夹持臂转动连接，所述第一夹持臂与所述连接座转动连接，所述第二夹持臂与所述连接座转动连接。
  16. 根据权利要求15所述的瓣膜修复装置，其特征在于，所述夹持结构还包括第三夹持臂与第四夹持臂，所述第三夹持臂与所述第一传动臂或所述固定 座连接，所述第四夹持臂与所述第二传动臂或所述固定座连接，所述第三夹持臂与所述第一夹持臂夹持配合，所述第四夹持臂与所述第二夹持臂夹持配合。
  17. 根据权利要求14或16所述的瓣膜修复装置，其特征在于，所述第三夹持臂朝向所述第一夹持臂的一侧设有倒刺，所述第四夹持臂朝向所述第二夹持臂的一侧设有倒刺。
  18. 根据权利要求13至16任一项所述的瓣膜修复装置，其特征在于，所述固定座设有通孔，所述通孔内壁设有第一螺纹，所述驱动轴上设有第二螺纹，所述驱动轴上具有所述第二螺纹的轴段的长度为L1，所述第一夹持臂或第二夹持臂的长度为L2，0:1＜L1:L2≤2:1。
  19. 一种瓣膜修复***，其特征在于，包括输送装置及权利要求1-18任一项所述的瓣膜修复装置，所述输送装置包括驱动件，所述驱动件与所述驱动轴可拆卸连接，所述驱动件用于驱使所述驱动轴相对所述固定座转动。
PCT/CN2022/135235 2021-12-22 2022-11-30 瓣膜修复装置及瓣膜修复*** WO2023116368A1 (zh)

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