WO2023241313A1

WO2023241313A1 - Control handle for loading accessory and prosthetic valve operating assembly

Info

Publication number: WO2023241313A1
Application number: PCT/CN2023/095507
Authority: WO
Inventors: 易澈; 章合强
Original assignee: 吉林启明皓月生物科技有限公司
Priority date: 2022-06-15
Filing date: 2023-05-22
Publication date: 2023-12-21
Also published as: CN117257517A

Abstract

Provided are a control handle (3) for loading an accessory and a prosthetic valve operating assembly, wherein the control handle (3) comprises: a plug-in part (31), the plug-in part (31) being rod-shaped, and one end of the plug-in part being a plug-in end (311) matched with the accessory; and a limiting part (32) connected to the plug-in part (31); a relative combination state and a separation state are provided between the control handle (3) and the accessory, and in the combination state, the accessory is matched with the limiting part (32) to keep the plug-in part (31) and the accessory connected; in the process of switching to the separation state, a connection part (312) between the limiting part (32) and the plug-in part (31) is deformed, the accessory is unmatched with the limiting part (32), and the plug-in part (31) is allowed to be separated from the accessory. By means of structural optimization of a valve measurement assembly (5), accurate measurement of a natural valve ring is achieved, and meanwhile, an adaptive structure basis is provided for subsequent operations, effectively improving operation efficiency, improving use feeling, and finally improving a treatment effect.

Description

Control handle for loading accessories and prosthetic valve operating components

Technical field

The present application relates to the field of medical devices, and in particular to control handles for loading accessories and artificial valve operating components.

Background technique

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.

Specifically, during the surgical replacement operation, 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. After determining a suitable artificial valve, 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.

In the prior art, 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. For example, 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. However, in actual situations, 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. Moreover, the patented valve measuring device is greatly affected by the operator during the adjustment process, resulting in large errors and inaccurate measurement results.

In addition, during surgical operations, it is necessary to use both a valve measuring device and a valve holder, which is inconvenient to operate.

Contents of the invention

In order to solve the above technical problems, this application discloses a control handle for selectively loading accessories, the control handle includes:

A plug-in part, the 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. In the combined 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 In the method, 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.

Optionally, 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.

Optionally, 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.

Optionally, the 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.

Optionally, the control part and the limiting part are integrated into a rod shape and are arranged side by side with the plug-in part.

Optionally, 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.

Optionally, the 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.

Optionally, 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.

Optionally, the accessory is a valve holder or a valve measuring assembly, and the control handle is used to connect the valve measuring assembly and the valve holder in sequence.

This application also discloses an artificial valve operating component, including:

The control handle in the above technical solution; and

An accessory that can be assembled separately from the control handle. 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.

Optionally, 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.

Optionally, 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.

Optionally, the 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.

Optionally, 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.

Optionally, 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; and

The anti-detaching device is arranged in the limiting chute and cooperates with the anti-decoupling device in the combined state.

Optionally, 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.

Optionally, 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.

Optionally, the 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; and

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.

This application also discloses an operating method for loading accessories using a control handle. 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:

Connect the control handle to the flap measuring assembly, so that the anti-detachment structure of the flap measuring assembly cooperates with the limiting part of the control handle, and keep the insertion part of the control handle on the flap measuring assembly The positioning hole cooperates with the plug-in part to obtain the first operating component;

Separate the control handle of the first operating component from the flap measuring component;

Connect the plug-in part of the control handle to the petal holder so that the anti-detachment structure of the petal holder cooperates with the limiting part of the control handle to keep the plug-in part of the control handle in place. The positioning hole of the petal holder cooperates with the plug-in part to obtain a second operating component.

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.

Specific beneficial technical effects will be further explained in combination with specific structures or steps in the specific implementation.

Description of the drawings

Figures 1 to 3 are schematic structural diagrams of the control handle in an embodiment;

Figures 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.

The reference symbols in the figure are explained as follows:

1. 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;

2. Artificial valve;

3. 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;

4. Wire binding; 41. Wire crimping groove; 42. Extension piece; 43. Wire blocking piece;

5. Measuring flap assembly; 51. Positioning hole; 52. Anti-falling structure; 521. Limiting chute; 522. Anti-falling teeth; 53. Fitting area.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of this application.

To be clear, 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. 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.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which this application belongs. The terms used herein in the description of the present application are only for the purpose of describing specific embodiments and are not intended to limit the present application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to Figures 1 to 5, the present application discloses a valve measurement assembly (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. In the combined state, the anti-detachment structure 52 cooperates with the limiting part 32 to keep the plug part 31 in the positioning hole 51;

The connection part 312 between the limiting part 32 and the plug-in part 31 can deform. During the switch to the separated state, 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.

During the measurement process, the 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.

In terms of specific implementation, with reference to the embodiment shown in the drawings, the deformation mode of the connection part of the control handle 3 is made of elastic material. In other embodiments, the connection portion of the control handle is deformed by a resettable hinge mechanism.

Furthermore, 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 . For example, 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 .

Furthermore, the plug end 311 has a round head structure. The plug-in part 31 is provided with a protruding blocking part 313. In the combined state, 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.

In the drawings, the 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.

Further, the 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. In the embodiment shown in the drawings, the connecting shaft 342 is connected to the adapting hole 3121 on the plug-in part 31 .

As for the arrangement of the connecting shaft 342, please refer to the figures. Compared with the one-way arrangement of the handle 341, it can also be arranged in multiple directions. For example, in one embodiment, 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. It can also be referred to in an embodiment that 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.

In the same way, the flap measuring assembly can also be arranged in one direction or in two directions. In the drawing, 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 . In other embodiments, positioning holes 51 and anti-detachment structures 52 are provided on both sides of the axial direction of the flap measuring assembly 5 .

Based on the above, it can be understood that the 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.

From the above description, it can be known that 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. In the combined 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. During the process of switching to the separated state, 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.

The specific settings of the control handle can be found in the above description and will not be repeated here.

In this embodiment, the 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.

It is easy to understand that the 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. In the drawings, the anti-separation structure 52 is provided on the radial outer peripheral surface of the positioning hole 51 .

In terms of coordination details, 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; and

The anti-detaching gear 522 is arranged in the limiting chute 521 and cooperates with the anti-detaching hook in the combined state.

In addition to guiding the limiting part 32, 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.

Furthermore, 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. In terms of the overall layout, 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.

As seen from the drawings, 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 . Similarly, 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 .

In the embodiment shown in Figure 4, 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. At the same time, 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.

It is easy to understand from the above description that the valve measuring assembly 5 of the present application can realize the working process through the control of the operating handle. In the subsequent operation process, 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 connection part 312 between the limiting part 32 and the plug-in part 31 can deform. During the process of switching to the separated state, 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;

The control handle 3 and the petal holder 1 have a relative combined state and a separated state. In the combined 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;

The connection part 312 between the limiting part 32 and the plug-in part 31 can be deformed. During the switching to the separated state, the 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.

In order to improve the utilization rate of components and reduce learning costs, 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.

During the operation, the 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 .

When the artificial valve 2 is in place, 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 . In contrast, 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.

In this embodiment, the 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. In particular, 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.

In this application, the 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. Specifically, 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.

In this embodiment, 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. In addition, each supporting base 143 is provided with a wire hole 145 for passing through the binding wire 4 . In this embodiment, 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.

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 .

It is understandable that the arrangement of the binding wires 4 is very important, and threading the binding wires 4 at inappropriate locations may cause interference or even a decrease in the restraint effect. Therefore, preferably, 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 . In this embodiment, 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. For example, in this embodiment, 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 .

During use, the valve holder 1 needs to be controlled through a control handle (as mentioned above). In this embodiment, as shown in FIG. 6 , 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. Specifically, the connecting seat 11 is generally cylindrical, and the insertion hole 15 is a through hole that axially penetrates the connecting seat 11 . In this embodiment, 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. Further, as shown in FIG. 6 , the connection base 11 has a snap portion 16 for cooperating with the control handle 3 . In this embodiment, the clamping portion 16 has a stepped structure.

Through the optimized setting of the valve holder 1, 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.

Usually, the operator can first connect the control handle to the valve measuring assembly. For example, 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. Further, the operator can use the first operating component to measure the flap.

Moreover, if the connected flap measuring assembly is not suitable, the operator can further replace a new flap measuring assembly and connect it to the control handle.

After determining the appropriate valve measuring component, 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.

Using the above method, the 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.

The technical features of the above-described embodiments can be combined in any way. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, All should be considered to be within the scope of this manual. When technical features in different embodiments are reflected in the same drawing, it can be regarded that the drawing also discloses combination examples of the various embodiments involved.

The above-described embodiments only express several implementation modes of the present application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the patent application. It should be noted that, for those of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all fall within the protection scope of the present application.

Claims

A control handle for selectively loading accessories, characterized in that the control handle includes:

A plug-in part, the 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. In the combined 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 In the method, 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 control handle for loading accessories according to claim 1, wherein 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.
The control handle for loading accessories according to claim 1, characterized in that one end of the limiting part is a connecting end connected to the plug-in part, and the other end is a limiting part that matches the accessory. end, and the limiting end is hook-shaped.
The control handle for loading accessories according to claim 1, characterized in that the control handle further includes a control part, and the control part is connected to at least one of the limiting part and the plug-in part. are connected together, and during the process of switching to the separated state, the control part drives the connecting part to deform.
The control handle for loading accessories according to claim 4, characterized in that the control part and the limiting part are in the shape of an integral rod and are arranged side by side with the insertion part.
The control handle for loading accessories according to claim 1, characterized in that the plug-in end has a round head structure, the plug-in part is provided with a protruding blocking part, and in the combined state, the blocking part Partially offset by the attachments.
The control handle for loading accessories according to claim 1, characterized in that the control handle further includes a handle and a malleable connecting shaft, one end of the connecting shaft is connected to the handle, and the connecting shaft The other end is connected to at least one of the plug part, the limiting part and the control part.
The control handle for loading accessories according to claim 7, characterized in that both ends of the handle are provided with connecting shafts, and one end of each connecting shaft away from the handle is connected to an independent plug-in part and the limiting portion;

The connecting shafts at both ends of the handle are configured independently or have an integrated structure and penetrate the handle.
The control handle for loading accessories according to claim 1, characterized in that the accessory is a flap holder or a flap measuring assembly, and the control handle is used to connect the flap measuring assembly and the flap holder in sequence .
The artificial valve operating component is characterized by including:

A control handle according to any one of claims 1 to 9; and

An accessory that can be assembled separately from the control handle. 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 artificial valve operating assembly according to claim 10, wherein 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 artificial valve operating assembly according to claim 10, wherein 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.
The artificial valve operating assembly according to claim 12, characterized in that the valve measuring 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, and the positioning The hole is opened on the top surface of the boss, and the anti-separation structure is provided on the side wall of the boss.
The artificial valve operating assembly according to claim 13, characterized in that the outer peripheral wall of one end of the cylindrical structure with positioning holes 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.
The artificial valve operating assembly according to claim 10, wherein one end of the limiting portion and the attachment is an anti-detachment provided toward the insertion portion;

The anti-falling structure includes:

a limiting chute, which accommodates at least a portion of the limiting portion in a combined state; and

The anti-detaching device is arranged in the limiting chute and cooperates with the anti-decoupling device in the combined state.
The artificial valve operating component according to claim 10, characterized in that the number of valve annulus measuring components of the valve measuring component is 2 to 8, and the outer diameter of each valve annulus is 18 to 30 mm.
The artificial valve operating assembly according to claim 10, wherein the 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; and

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.
An operating method for loading accessories using a control handle, characterized in that the control handle includes a plug-in part and a limiting part, the accessory is a flap holder or a flap measuring assembly, and the flap holder and the flap measuring assembly are The components are equipped with positioning holes and anti-separation structures; the method includes:

Connect the control handle to the flap measuring assembly, so that the anti-detachment structure of the flap measuring assembly cooperates with the limiting part of the control handle, and keep the insertion part of the control handle on the flap measuring assembly The positioning hole cooperates with the plug-in part to obtain the first operating component;

Separate the control handle of the first operating component from the flap measuring component;

Connect the plug-in part of the control handle to the petal holder so that the anti-detachment structure of the petal holder cooperates with the limiting part of the control handle to keep the plug-in part of the control handle in place. The positioning hole of the petal holder cooperates with the plug-in part to obtain a second operating component.