WO2023241313A1 - Poignée de commande pour charger un accessoire et un ensemble de fonctionnement de prothèse valvulaire - Google Patents

Poignée de commande pour charger un accessoire et un ensemble de fonctionnement de prothèse valvulaire Download PDF

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Publication number
WO2023241313A1
WO2023241313A1 PCT/CN2023/095507 CN2023095507W WO2023241313A1 WO 2023241313 A1 WO2023241313 A1 WO 2023241313A1 CN 2023095507 W CN2023095507 W CN 2023095507W WO 2023241313 A1 WO2023241313 A1 WO 2023241313A1
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WO
WIPO (PCT)
Prior art keywords
valve
control handle
plug
accessory
limiting
Prior art date
Application number
PCT/CN2023/095507
Other languages
English (en)
Chinese (zh)
Inventor
易澈
章合强
Original Assignee
吉林启明皓月生物科技有限公司
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Filing date
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Application filed by 吉林启明皓月生物科技有限公司 filed Critical 吉林启明皓月生物科技有限公司
Publication of WO2023241313A1 publication Critical patent/WO2023241313A1/fr

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Classifications

    • 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
    • A61F2/2496—Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
    • 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
    • A61F2/02—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

Definitions

  • the present application relates to the field of medical devices, and in particular to control handles for loading accessories and artificial valve operating components.
  • Valvular heart disease is a common form of heart disease, with valve damage caused by rheumatic fever being the most common. As the population ages, senile valvular disease and valvular lesions caused by coronary heart disease and myocardial infarction are becoming more and more common.
  • Heart valves include the aortic valve, pulmonary valve, mitral valve and tricuspid valve. The opening and closing of these valves control the one-way flow of blood in the heart to ensure the normal operation of the human blood circulation. When valve disease occurs, such as valve calcification, valve leaflet prolapse, etc., the valve cannot open and close normally, leading to a series of diseases.
  • a common treatment for diseased aortic valves is replacement with an artificial heart valve.
  • the two main categories of biological aortic valve replacement are surgical replacement and transcatheter interventional replacement. Because of the relative lack of long-term durability data for transcatheter valves, younger patients (e.g., under 65 years of age) and patients with low surgical risk often receive surgically replaced heart valves.
  • the patient's chest will be opened, the heart will be stopped, and extracorporeal circulation will be established.
  • the surgeon will remove the diseased natural valve, and then use a valve measuring device to measure the size of the natural valve annulus, and select the appropriate size based on the measurement results.
  • artificial valve This is because although the size of the patient's natural valve annulus can be estimated through imaging equipment before surgery, the estimated results may have errors. Direct measurement using a valve measuring device during actual surgery can yield more accurate results.
  • the artificial valve can be connected to the valve holder, for example, by suturing, and then the doctor will place the artificial valve on the natural annulus through the valve holder and cut off the connecting sutures. The thread separates the artificial valve from the valve holder and fixes the artificial valve to the natural annulus.
  • valve detectors usually have many different models, such as 19mm, 21mm, 23mm, and 27mm, and different models of valve detectors need to be replaced during measurement.
  • the doctor can first use a 19mm valve holder to measure. If it is found that it is smaller than the natural valve annulus, it can be replaced with a 21mm valve holder and measured again. If it is found that it is smaller than the natural valve annulus, it can be replaced with a 23mm valve holder. The device is measured again, and this cycle is continued until the appropriate type of valve holder is determined. This method is more inconvenient to operate, and multiple replacements of the valve holder will also lengthen the operation time.
  • Patent CN211485098U discloses an adjustable valve holder.
  • the valve measuring assembly 1 at the distal end is hinged by multiple connecting pieces.
  • the expansion size can be adjusted according to needs, so there is no need to replace the valve holder multiple times.
  • the human natural valve annulus is probably not a regular circle, and its diameter may be different at different positions.
  • Using the patented valve measuring device for measurement can only measure the natural valve in some positions. The artificial valve selected based on these diameters may not be suitable.
  • the patented valve measuring device is greatly affected by the operator during the adjustment process, resulting in large errors and inaccurate measurement results.
  • control handle for selectively loading accessories, the control handle includes:
  • a plug-in part is rod-shaped, and one end thereof is a plug-in end that cooperates with the accessory;
  • the limiting part is connected to the plug-in part
  • the control handle and the accessory have a relative combined state and a separated state.
  • the accessory cooperates with the limiting part to keep the plug-in part and the accessory connected; during the process of switching to the separated state
  • the connection part between the limiting part and the plug-in part is deformed, the accessory is disengaged from the limiting part, and the plug-in part and the accessory are allowed to be separated.
  • the side of the plug-in part away from the plug-in end is a connection part connected to the limiting part;
  • the deformation mode of the connecting part is a resettable hinge mechanism or elastic material.
  • one end of the limiting part is a connecting end connected to the plug-in part, and the other end is a limiting end that matches the accessory, and the limiting end is hook-shaped.
  • control handle also includes a control part, the control part is connected to at least one of the limiting part and the plug-in part, and during the process of switching to the separation state, through the control part The part drives the connecting part to deform.
  • control part and the limiting part are integrated into a rod shape and are arranged side by side with the plug-in part.
  • the plug-in end has a round head structure, and the plug-in part is provided with a protruding blocking portion. In the combined state, the blocking portion offsets the accessory.
  • control handle also includes a handle and a malleable connecting shaft.
  • One end of the connecting shaft is connected to the handle, and the other end of the connecting shaft is connected to the insertion part, the limiting part and the control part. At least one of the three is connected.
  • both ends of the handle are provided with connecting shafts, and one end of each connecting shaft away from the handle is connected to the independent plug-in part and the limiting part;
  • the connecting shafts at both ends of the handle are configured independently or have an integrated structure and penetrate the handle.
  • the accessory is a valve holder or a valve measuring assembly
  • the control handle is used to connect the valve measuring assembly and the valve holder in sequence.
  • an artificial valve operating component including:
  • the accessory is any one of a valve measuring assembly and a valve holder. Both the valve measuring assembly and the valve holder are provided with positioning holes and anti-detachment structures; In the combined state, the anti-detachment structure cooperates with the limiting portion of the control handle to maintain the insertion portion of the control handle in the positioning hole.
  • the positioning holes and anti-detachment structures on the valve measuring assembly and the valve holder have the same specifications, and can be installed alternately on the control handle.
  • the valve measuring assembly includes several valve measuring rings with different outer diameters;
  • the positioning hole and the anti-detachment structure are provided on one side of the valve measuring annulus in the axial direction; or
  • the positioning holes and the anti-detachment structure are provided on both sides of the axial direction of the flap measuring assembly.
  • valve measuring ring is a columnar structure as a whole, and the axial end surface of the columnar structure is partially concave to form a relative concave area and a boss, and the positioning hole is opened on the top surface of the boss, so The anti-separation structure is provided on the side wall of the boss.
  • the outer peripheral wall of one end of the columnar structure with the positioning hole is continuously distributed and surrounds the recessed area and the boss;
  • the positioning hole is eccentrically arranged relative to the valve measuring annulus, and the anti-detachment structure is located on the peripheral side wall of the boss close to the center of the valve measuring annulus.
  • one end of the limiting part that matches the accessory is an anti-detachment hook arranged toward the plug-in part;
  • the anti-falling structure includes:
  • a limiting chute which accommodates at least a portion of the limiting portion in a combined state
  • the anti-detaching device is arranged in the limiting chute and cooperates with the anti-decoupling device in the combined state.
  • the number of valve measuring rings of the valve measuring assembly is 2 to 8, and the outer diameter of each valve measuring ring is 18 to 30 mm.
  • the number of valve measuring rings of the valve measuring assembly is 4, and the outer diameters of each valve measuring ring are 19 mm, 21 mm, 23 mm and 25 mm respectively.
  • valve holder includes:
  • a connecting seat the connecting seat has an axial direction, one end of the axial direction of the connecting seat is a distal end facing the artificial heart valve, and the other end is a proximal end facing away from the artificial heart valve;
  • At least one arm is distributed around the periphery of the connecting seat, and the at least one arm has a positioning structure at its distal end that matches the outflow side of the artificial heart valve; at least one arm has a frame for The binding wire that binds the artificial heart valve is wound around, the frame has a wire passing path and a wire cutting port corresponding to the wire passing path, and the wire passing path allows the binding wire to be cut along the wire passing path. Extended line segments are left hanging.
  • the control handle includes a plug-in part and a limiting part.
  • the accessory is a valve holder or a valve measuring assembly.
  • the valve holder and the measuring valve are The valve components are equipped with positioning holes and anti-detachment structures; the method includes:
  • the technical solution disclosed in this application achieves accurate measurement of the natural valve annulus through structural optimization of the valve measurement component, and at the same time provides an adapted structural basis for subsequent operations, effectively improves operating efficiency, improves user experience, and ultimately improves treatment effects.
  • FIGS 1 to 3 are schematic structural diagrams of the control handle in an embodiment
  • FIGS. 4 to 5 are schematic structural diagrams of a flap measuring component of a certain size in an embodiment
  • Figures 6 to 8 are schematic structural diagrams of the valve holder in one embodiment
  • Figures 9 to 13 are schematic diagrams of the matching structure of the control handle and the petal holder in one embodiment
  • 14 to 15 are schematic diagrams of the cooperation between the control handle, the valve holder and the artificial valve in one embodiment.
  • Valve holder 11. Connecting seat; 12. Arm; 121. Threading hole; 122. Wire knot hole; 13. Positioning structure; 14. Frame; 141. Wire passing path; 142. Wire cutting port; 143. Supporting base; 144, cable slot; 145, cable hole; 15, plug hole; 16, clamping part;
  • Control handle 31. Plug-in part; 311. Plug-in end; 312. Connection part; 3121. Adapting hole; 313. Blocking part; 32. Limiting part; 321. Connection end; 322. Limiting end; 33. Control part; 341. Grip; 342. Connecting shaft;
  • a component when a component is said to be “connected” to another component, it can be directly connected to the other component or there can also be an intermediate component.
  • a component When a component is said to be “set on” another component, it can be directly set on the other component or there may be a centered component at the same time.
  • valve measurement assembly which includes a control handle 3 and a valve measurement assembly 5 that is detachably assembled from the control handle 3.
  • the control handle 3 includes a plug-in connector. part 31 and the limiting part 32 provided on the plug-in part 31, and the flap measuring assembly 5 is provided with a positioning hole 51 and an anti-detachment structure 52;
  • the control handle 3 and the flap measuring assembly 5 have a relative combined state and a separated state.
  • the anti-detachment structure 52 cooperates with the limiting part 32 to keep the plug part 31 in the positioning hole 51;
  • connection part 312 between the limiting part 32 and the plug-in part 31 can deform.
  • the anti-detachment structure 52 disengages the limiting part 32 through the deformation of the connection part and allows the plug-in part 31 to detach. Positioning hole 51.
  • control handle 3 allows the valve measuring assembly 5 to be properly positioned and is configured to be connected to the valve measuring assembly 5 through the plug portion 31 , which can facilitate medical personnel to control the valve measuring assembly 5 through the control handle 3 , and the working states of the control handle 3 and the petal holder 1 can be switched through the limiting part 32. This facilitates the assembly and separation of the flap measuring components 5 and the control handle 3 of different sizes.
  • connection part of the control handle 3 is made of elastic material.
  • connection portion of the control handle is deformed by a resettable hinge mechanism.
  • the plug-in part 31 is rod-shaped, one end of which is the plug-in end 311 that cooperates with the measuring flap assembly 5 , and the other end is adjacent to the connection part 312 connected to the limiting part 32 .
  • the adapting hole 3121 is defined on the plug-in part 31 and is a blind hole opened on the plug-in part 31 for installing auxiliary accessories to control the control handle 3 .
  • the auxiliary accessory may be a rod inserted and extending axially along the plug-in part 31 to achieve relative movement between the plug-in part 31 and the limiting part 32 .
  • the rod may be a malleable connecting shaft 342 as described below, which may be bonded or insert-molded within the plug portion 31 .
  • the plug end 311 has a round head structure.
  • the plug-in part 31 is provided with a protruding blocking part 313.
  • the blocking part 313 and the flap measuring assembly 5 are in position to limit the axial position of the control handle 3 relative to the flap measuring assembly 5.
  • the blocking portion 313 extends around the outer periphery of the plug-in portion 31 .
  • One end of the limiting part 32 is a connecting end 321 connected to the plug-in part 31 , and the other end is a limiting end 322 matching with the flap measuring assembly 5 . Furthermore, the limiting end 322 is hook-shaped and is used to cooperate with the anti-detachment structure 52 on the flap measuring assembly 5 as described above.
  • the plug end 311 extends 2% to 30% beyond the end surface of the limiting end 322 in the axial direction.
  • the control part 33 is fixedly connected to the limiting part 32 .
  • the control part 33 and the limiting part 32 are both rod-shaped and have the same extending direction.
  • the limiting part 32 and the plug-in part 31 are arranged substantially parallel to each other.
  • the insertion part 31, the limiting part 32 and the control part 33 are of an integrated structure.
  • control handle 3 also includes a control part 33, which is connected to at least one of the limiting part 32 and the plug-in part 31.
  • the control part 33 is used to drive the deformation of the connection part.
  • control handle 3 also includes a handle and a malleable connecting shaft 342.
  • One end of the connecting shaft 342 is connected to the handle 341, and the other end of the connecting shaft 342 is connected to the insertion part 31, the limiting part 32, and the control part 33. At least one of these three is connected.
  • the connecting shaft 342 is connected to the adapting hole 3121 on the plug-in part 31 .
  • both ends of the handle 341 are connected with independent connections.
  • Shaft 342 one end of each connecting shaft 342 away from the handle 341 is connected to an independent plug-in part 31 and a limiting part 32.
  • the connecting shaft 342 penetrates the handle 341, and the two ends of the connecting shaft 342 are respectively connected with independent plug-in parts 31 and limiting parts 32.
  • the flap measuring assembly can also be arranged in one direction or in two directions.
  • the positioning hole 51 and the anti-separation structure 52 are arranged on one side of the axial direction of the flap measuring assembly 5 .
  • positioning holes 51 and anti-detachment structures 52 are provided on both sides of the axial direction of the flap measuring assembly 5 .
  • control handle 3 can be equipped with valve measuring assemblies 5 of different sizes on both ends, or the valve measuring assembly 5 can be installed on one end and the valve holder 1 can be installed on the other end.
  • the control handle 3 can be flexibly arranged to improve operating efficiency and adaptability.
  • the present application also discloses a control handle for selectively loading accessories.
  • the accessories may be, for example, a valve measuring assembly and a valve holder.
  • the control handle can be connected to the valve measuring assembly and the valve holder in sequence.
  • the control handle includes: a plug-in part; a limiting part provided on the plug-in part;
  • the control handle and the accessory have a relative combined state and a separated state.
  • the accessory cooperates with the limiting part to keep the plug-in part and the accessory connected; the connection part between the limit part and the plug-in part can deform.
  • the accessory is decoupled from the limiting part through the deformation of the connection part, and allows the plug part to be separated from the accessory.
  • control handle has a universal function, that is, it can selectively connect the valve measuring component and the valve holder according to actual needs, so that there is no need to frequently change instruments during the operation, and the operation is more convenient.
  • valve measuring assembly 5 includes several valve measuring rings with different outer diameters.
  • Each valve measuring ring is provided with a positioning hole 51 and an anti-detachment structure 52.
  • the size of the positioning hole 51 and the anti-detachment structure 52 of each valve ring is determined.
  • the form is the same and can be adapted to the same control handle 3.
  • the anti-separation structure 52 is provided on the radial outer peripheral surface of the positioning hole 51 .
  • the limiting portion 32 is provided with an anti-decoupling device facing the plug portion 31 (which can be implemented by the hook-shaped limiting end 322 mentioned above, or a separate anti-decoupling device can be provided).
  • the anti-off structure 52 includes:
  • the limiting chute 521 accommodates at least a portion of the limiting portion 32 in the combined state
  • the anti-detaching gear 522 is arranged in the limiting chute 521 and cooperates with the anti-detaching hook in the combined state.
  • the limiting chute 521 can also be used to realize radial restraint of the limiting part 32, thereby enabling the control handle 3 to drive the rotation of the flap measuring assembly 5, thereby improving Test the adaptability of the valve components to work.
  • This effect also has a synergistic effect with the layout and position of the anti-separation structure 52 and the positioning hole 51 mentioned below.
  • the measuring valve annulus is a columnar structure as a whole, and the axial end surface of the columnar structure is partially concave to form a relative concave area and a boss.
  • the positioning hole 51 is opened on the top surface of the boss, and the anti-falling structure 52 is provided on the top of the boss. side walls.
  • the columnar structure is provided with positioning holes 51 that are continuously distributed on the outer peripheral wall at one end and surrounds the concave area and the boss; the positioning hole 51 is set eccentrically compared to the valve measuring annulus, and the anti-detachment structure 52 is located on the boss and close to the valve measuring annulus. on the peripheral side walls of the center.
  • the top of the valve measuring ring is concave to form a fitting area 53, and the positioning hole 51 and the anti-detachment structure 52 are provided in the fitting area 53.
  • the matching area 53 can form a relatively closed space to avoid interference with surrounding tissues.
  • the positioning hole 51 is arranged eccentrically compared to the geometric center of the fitting area 53 . This setting can facilitate the working process of the flap measuring assembly 5 .
  • the anti-separation structure 52 is located on the outer peripheral side wall of the positioning hole 51 close to the geometric center of the fitting area 53 .
  • the middle part of the axial length of the valve annulus is provided with a marking line surrounding the periphery of the valve annulus.
  • This marking line can mark its position relative to the native valve annulus when the valve annulus is in use. Avoid pushing the annulus too far inward.
  • the marking line can also be used to hide process defects. For example, when the process parting line is set at the marking line, the influence of the parting line on the overall shape of the measuring valve annulus can be avoided.
  • valve measuring assembly 5 of the present application can realize the working process through the control of the operating handle.
  • the handle 3 is also required to control the operation, such as the delivery process of the artificial valve 2. Therefore, with reference to the embodiments shown in Figures 1 to 15, this application also discloses an operating assembly of the artificial valve 2, including
  • the valve measuring component 5 includes several valve measuring rings with different outer diameters. Each measuring valve ring is used to measure the size of the native valve. Each measuring valve ring includes a positioning hole 51 and an anti-detachment structure 52;
  • the valve holder 1 is used to position the artificial valve 2.
  • the valve holder 1 is provided with an insertion hole 15 and a clamping portion 16;
  • the control handle 3 includes a plug-in part 31 and a limiting part 32;
  • the control handle 3 and the flap measuring assembly 5 have a relative combined state and a separated state.
  • the anti-detachment structure 52 cooperates with the limiting part 32 to keep the plug part 31 in the positioning hole 51;
  • connection part 312 between the limiting part 32 and the plug-in part 31 can deform.
  • the anti-detachment structure 52 disengages the limiting part 32 through the deformation of the connection part and allows the plug-in part 31 to detach.
  • the control handle 3 and the petal holder 1 have a relative combined state and a separated state.
  • the snap-in part 16 cooperates with the limiting part 32 to keep the plug-in part 31 in the plug-in hole 15;
  • connection part 312 between the limiting part 32 and the plug-in part 31 can be deformed.
  • clamping part 16 disengages the limiting part 32 through the deformation of the connection part and allows the plug-in part 31 to disengage. Plug hole 15.
  • the positioning holes 51 and the anti-detachment structures 52 between each valve ring, as well as the insertion hole 15 and the snap-in part 16 on the valve holder 1 can be set to the same size, which can Mates with same size control handle 3.
  • control handle 3 allows the artificial valve 2 to be properly positioned and is configured to be connected to the valve holder 1 through the plug-in part 31 , which can facilitate the medical staff to control and install the valve holder 1 through the control handle 3
  • the artificial valve 2 on the valve holder 1 is controlled, and the working states of the control handle 3 and the valve holder 1 can be switched through the limiting portion 32 .
  • the medical staff can easily remove the control handle 3 from the valve holder 1 while maintaining the assembled relationship between the valve holder 1 and the artificial valve 2 .
  • commercially available control handle joints connect to the threaded interface of the valve holder and require bending during surgery so that the control handle joint cannot be rotated away from the valve holder after the prosthetic heart valve is in place. Therefore, the existing control handle joint can only be removed by detaching the valve holder from the artificial heart valve, particularly by cutting the multiple binding wires on the valve holder. After the valve holder is removed from the artificial heart valve, the valve holder no longer provides protection for the artificial heart valve during subsequent suturing or other operations.
  • control handle 3 can be easily connected and removed without affecting the connection between the valve holder 1 and the artificial valve 2, thereby realizing the protection of the artificial valve 2 by the valve holder 1.
  • the valve holder 1 can exert force inwardly on the artificial valve 2 along the radial direction of the connecting seat 11 to drive the various parts of the artificial valve 2 to move toward each other, which can avoid the artificial valve 2 itself from interfering with the suturing process and/or or deformation.
  • valve holder 1 and the valve measuring assembly 5 can share the same structure of the control handle 3, which not only improves the component sharing rate, but also reduces the learning cost of medical staff and improves the use experience.
  • the petal holder can adopt a mechanism in the prior art. Please refer to the embodiment shown in Figures 7 to 8.
  • the petal holder 1 includes:
  • the connecting seat 11 has an axial direction. One end of the axial direction of the connecting seat 11 is the distal end facing the artificial heart valve, and the other end is the proximal end facing away from the artificial heart valve; and
  • At least one arm 12 is distributed around the periphery of the connecting seat 11. At least one arm 12 has a positioning structure 13 at its distal end that matches the outflow side of the artificial heart valve; at least one arm 12 has a frame for surrounding it.
  • the binding wire 4 for binding the artificial heart valve is placed.
  • the frame has a wire passing path and a wire cutting port 142 corresponding to the wire passing path. The wire passing path allows the line segment of the binding wire 4 extending along the wire passing path to be suspended.
  • the setting of the thread trimming port 142 reduces the trouble and surgical risk caused by the thread trimming operation.
  • the wire-cutting port 142 can be set independently, and a corresponding protective structure can be set up to guide and protect the cutting tool; in addition, the extension path of the binding wire 4 is single and passes through the wire-cutting port 142, so that the wire-cutting port 142 can be
  • the cutting operation of 142 can realize the release of the binding wire, thereby realizing the separation of the valve holder 1 and the artificial valve 2, thus effectively reducing the operation time.
  • Medical staff can adjust the implantation direction of the artificial valve 2 according to the anatomical structure to facilitate the operation of the thread-cutting port 142, thereby reducing the patient's surgical risk.
  • the frame 14 is fixed on the arm 12 and includes at least a pair of supporting seats 143 arranged oppositely. Specifically, along the circumferential direction of the connecting seat 11, two supporting seats 143 are respectively distributed on two opposite sides of the holding arm 12, and the gap between the pair of supporting seats 143 serves as the thread trimming opening 142.
  • Each supporting base 143 is provided with a wire clamping slot 144 for passing through the binding wire 4, and the wire passing path 141 is between the two wire clamping slots 144 of the two supporting seats 143.
  • each supporting base 143 is provided with a wire hole 145 for passing through the binding wire 4 .
  • the cable hole 145 is located at the bottom of the supporting base 143, and the supporting base 143 extends from the holding arm 12 at its bottom.
  • the holding arm 12 In order to improve the ability of the holding arm 12 to restrain the binding wire 4, preferably, the holding arm 12 also has at least one threading hole 121 for threading the binding wire 4 that binds the artificial valve 2. Therefore, after cutting the binding wire 4, all the binding wire 4 fragments are still attached to the valve holder 1, which can prevent any binding wire 4 fragments from remaining in the patient's body. More preferably, at least one holding arm 12 is provided with a pair of wire knot holes 122 for fixing the binding wire 4 . The wire knot hole 122 can conveniently retain the fragments of the binding wire 4 on the valve holder 1 . In this embodiment, a pair of wire knot holes 122 is limited to the two holding arms 12 .
  • a wire crimping groove 41 for passing the binding wire 4 is provided between two adjacent holding arms 12, as shown in FIG. 8 .
  • the crimping groove 41 has the same orientation or opening as the positioning structure 13 .
  • a radially outwardly protruding extension piece 42 is fixed on the outer periphery of the connecting base 11 , and a wire crimping groove 41 is opened in each corresponding extension piece 42 .
  • the petal holder 1 may also be provided with a structure on the holding arm 12 to constrain the wire threading path.
  • at least one holding arm 12 is provided with a wire blocking member 43 for limiting the extension tendency of the binding wire 4, as shown in FIG. 8 .
  • the connecting base 11 is provided with a plug hole 15 extending in the axial direction for cooperating with the control handle 3 of the control handle.
  • the connecting seat 11 is generally cylindrical, and the insertion hole 15 is a through hole that axially penetrates the connecting seat 11 .
  • one end of the connecting seat 11 on its bottom side has an outer diameter convergence structure.
  • the outer diameter convergence structure can be formed by synchronous necking inside and outside the cylinder, or can also be represented by the chamfering of the outer wall as shown in Figure 6.
  • the connection base 11 has a snap portion 16 for cooperating with the control handle 3 .
  • the clamping portion 16 has a stepped structure.
  • this embodiment avoids the interference of the valve holder 1 in the holding, positioning and releasing process of the artificial valve 2, and at the same time provides a structural basis for the arrangement of surrounding matching components, thereby optimizing the medical staff. operation experience and improve treatment effects.
  • This application also provides an operating method for loading accessories using a control handle.
  • the specific structure of the control handle refers to the above description, and the accessories can be a valve measuring tool and a valve holder.
  • the operator can first connect the control handle to the valve measuring assembly.
  • the anti-detachment structure of the valve measuring assembly can be matched with the limiting part of the control handle, and the plug-in part of the control handle can be kept in the positioning hole of the measuring valve assembly.
  • Cooperate with the plug-in part to obtain the first operating component.
  • the operator can use the first operating component to measure the flap.
  • the operator can further replace a new flap measuring assembly and connect it to the control handle.
  • the operator can separate the control handle of the first operating component from the valve measuring component, and connect the plug-in part of the control handle to the valve holder, so that the anti-detachment structure of the valve holder is in contact with the control valve.
  • the limiting part of the handle cooperates to keep the plug-in part of the control handle in the positioning hole of the petal holder and cooperates with the plug-in part to obtain the second operating component. Further, the operator can use the first operating component to implant the valve.
  • control handle can be used to connect the valve measuring component and the valve holder in sequence, without the need to frequently change instruments, making the operation more convenient, improving efficiency, and reducing the length of the operation.

Landscapes

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

Abstract

L'invention concerne une poignée de commande (3) pour charger un accessoire et un ensemble de fonctionnement de prothèse valvulaire, la poignée de commande (3) comprenant : une partie enfichable (31), la partie enfichable (31) présentant une forme de tige, et une extrémité de la partie enfichable étant une extrémité enfichable (311) correspondant à l'accessoire ; et une partie de limitation (32) reliée à la partie enfichable (31) ; un état de combinaison et un état de séparation relatifs étant prévus entre la poignée de commande (3) et l'accessoire, et, dans l'état de combinaison, l'accessoire étant mis en correspondance avec la partie de limitation (32) pour maintenir la liaison entre la partie enfichable (31) et l'accessoire ; dans le processus de commutation vers l'état de séparation, une partie de liaison (312) entre la partie de limitation (32) et la partie enfichable (31) étant déformée, l'accessoire n'étant pas mis en correspondance avec la partie de limitation (32), et la partie enfichable (31) pouvant être séparée de l'accessoire. Au moyen d'une optimisation structurale d'un ensemble de mesure de valve (5), une mesure précise d'un anneau de valve naturelle est obtenue, et dans le même temps, une base de structure adaptative est fournie pour des fonctionnements ultérieurs, améliorant efficacement l'efficacité de fonctionnement, améliorant la sensation lors de l'utilisation, et enfin, améliorant un effet de traitement.
PCT/CN2023/095507 2022-06-15 2023-05-22 Poignée de commande pour charger un accessoire et un ensemble de fonctionnement de prothèse valvulaire WO2023241313A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202210681283.5 2022-06-15
CN202210681283.5A CN117257517A (zh) 2022-06-15 2022-06-15 用于装载附件的控制手柄以及人工瓣膜操作组件

Publications (1)

Publication Number Publication Date
WO2023241313A1 true WO2023241313A1 (fr) 2023-12-21

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CN (1) CN117257517A (fr)
WO (1) WO2023241313A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040097911A1 (en) * 2001-02-13 2004-05-20 Olympus Optical Co., Ltd. Ultrasonic operating apparartus and tool for changing tip thereof
DE10357104A1 (de) * 2003-12-06 2005-07-14 Richard Wolf Gmbh Medizinisches Instrument
US20080033545A1 (en) * 2006-08-02 2008-02-07 Medtronic, Inc. Heart valve holder for use in valve implantation procedures
US20090281609A1 (en) * 2008-02-29 2009-11-12 Edwards Lifesciences Two-step heart valve implantation
CN112890897A (zh) * 2021-01-18 2021-06-04 江苏钱璟医疗器械有限公司 刀头可更换式点切吻合器
CN114828782A (zh) * 2021-10-07 2022-07-29 吉林启明皓月生物科技有限公司 用于保持和输送外科心脏瓣膜的系统和方法

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040097911A1 (en) * 2001-02-13 2004-05-20 Olympus Optical Co., Ltd. Ultrasonic operating apparartus and tool for changing tip thereof
DE10357104A1 (de) * 2003-12-06 2005-07-14 Richard Wolf Gmbh Medizinisches Instrument
US20080033545A1 (en) * 2006-08-02 2008-02-07 Medtronic, Inc. Heart valve holder for use in valve implantation procedures
US20090281609A1 (en) * 2008-02-29 2009-11-12 Edwards Lifesciences Two-step heart valve implantation
CN112890897A (zh) * 2021-01-18 2021-06-04 江苏钱璟医疗器械有限公司 刀头可更换式点切吻合器
CN114828782A (zh) * 2021-10-07 2022-07-29 吉林启明皓月生物科技有限公司 用于保持和输送外科心脏瓣膜的系统和方法

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