CN211723546U - A valve clamp and its clamping system - Google Patents

Abstract

A valve clamp and a clamping system thereof, which can effectively treat mitral regurgitation (MR) and tricuspid regurgitation (TR) after being implanted into a human body by means of the clamping system. The valve clamp can shorten the axial operation space of the valve clamp, change the operation direction, and perform capture and clamping operations from the other side of the valve (ie, the atrium side), and reduce the impact on the atrium and the atrium during the operation. The risk of damage to the chordae tendineae can also shorten the length of the valve clamp and make the implanted valve clamp shorter, so as to reduce the space occupied by the valve clamp on the ventricular side and reduce the possible damage to the heart tissue caused by the valve clamp. , reduce the risk of thrombosis, in addition, after the clipping system passes through the femoral vein and punctures the septum between the right atrium and the left atrium, the right atrium and the left atrium are used as the delivery path of the clip, and there is no need to cut the intercostal space and puncture the apex, Surgery is less traumatic.

Description

A valve clamp and its clamping system

technical field

The utility model relates to a valve clamp, in particular to a valve clamp and a clamping system thereof.

Background technique

The mitral valve is a two-piece valve attached to the periphery of the left atrioventricular orifice (as shown in Figure 1).

Mitral regurgitation (MR) is caused by the poor anastomosis of the anterior and posterior mitral valve leaflets due to qualitative or functional changes in the mitral valve leaflets and their related structures, and blood flow from the left ventricle to the left atrium, causing a series of pathological changes. Physiological changes. Severe MR can cause left ventricular enlargement, which eventually leads to left ventricular systolic dysfunction and heart failure. At the same time, left atrial pressure also increases due to reflux, which can easily lead to left atrial enlargement, atrial fibrillation, and pulmonary hypertension. The prognosis of MR is poor, with an annual mortality rate of about 5% in symptomatic patients without surgery, and a 5-year mortality rate of 60% in patients with severe heart failure. At the same time, MR is also one of the most common heart diseases. According to statistics, the incidence rate of people over 65 and 75 years old is 6.4% and 9.3%, respectively. With the development of economy and society and the aging of the population, the incidence of mitral valve regurgitation is on the rise.

Surgical valve repair or replacement is considered the standard treatment for the disease. However, surgery has the disadvantages of large trauma, obvious postoperative pain, slow recovery, and high risk. In addition, some patients with advanced age, history of thoracotomy, poor cardiac function, and multiple organ insufficiency are often treated due to high surgical risks. refused surgery. Therefore, the development of minimally invasive, low-risk interventional therapy devices for MR has huge social benefits and market demands. In recent years, with the breakthrough development of valve interventional therapy technology, MR interventional devices have now become one of the key directions in the research and development of cardiovascular devices at home and abroad.

Among them, the valve clamp instrument developed according to the principle of surgical valve edge-to-edge suture technology is currently the most recognized because of its high safety, simple technical principle and great feasibility. The principle of surgical valve edge-to-edge suture technique is shown in Figure 2: When mitral valve regurgitation occurs, the edges of the two valve leaflets cannot be closed and closed during systole, resulting in the left ventricular blood flow returning to the left atrium from the gap; the surgical edge Opposite suture sutures the midpoint between the edges of the two leaflets of the mitral valve, so that the space between the leaflets disappears or becomes smaller during systole, thereby reducing mitral regurgitation (Fig. 2a), while the mitral valve opens during diastole. In the form of a double hole, blood flow into the left ventricle is not affected (Fig. 2b). The only minimally invasive interventional device approved for the treatment of MR in the world is Evalve's MitraClip, which is a valve clamping device.

Patent CN106175986A developed by Zhongshan Hospital Affiliated to Fudan University and exclusively owned by Hanyu Medical Technology Co., Ltd. discloses a valve clamp, which discloses a valve clamp for capturing and clamping operation from the ventricular side of the valve. We developed and used this patent. Through actual operation, we found that the device still has too much operating space to capture the valve, and it can only be operated through the ventricular side (the wound from the apex is still too large), and it is easy to wind the tendon. It is easy to damage the atrial roof and can only capture defects on both sides of the valve at the same time.

Therefore, in view of the above defects, it is necessary to effectively innovate the existing technology.

Utility model content

The utility model is devoted to developing a valve clamp and a clamping system thereof, which can effectively treat mitral regurgitation (MR) and tricuspid regurgitation (TR) after being implanted into the human body by means of the clamping system ). The valve clamp can shorten the axial operation space of the valve clamp, change the operation direction, and perform capture and clamping operations from the other side of the valve (ie, the atrium side), and reduce the impact on the atrium and the atrium during the operation. The risk of damage to the chordae tendineae can also shorten the length of the valve clamp and make the implanted valve clamp shorter, so as to reduce the space occupied by the valve clamp on the ventricle side and reduce the possible damage to the heart tissue caused by the valve clamp. , reducing the risk of thrombosis. In addition, the clipping system uses the right atrium and left atrium as the delivery path of the clip after passing through the femoral vein and puncturing the septum between the right atrium and the left atrium. Surgery is less traumatic.

To achieve the above object, the utility model adopts the following technical solutions:

A valve clamp, comprising a clamping part and a fixing part, the clamping part comprises a base, a fixing rod, a first clamping part, and a second clamping part, the base has a first connection structure, and the The fixing rod, the first clamping part and the second clamping part are arranged on the base, the proximal end of the fixing rod has a second connection structure, and the first clamping part has at least two first clamping parts. Clamping arms, the second clamping member has a corresponding number of second clamping arms, the outer side of the second clamping arms is provided with a clamping structure, and each of the first clamping arms is associated with its corresponding The second clamping arm forms a set of clamps, the fixing part and the base are detachably connected, the inner side and the proximal end of the fixing part are respectively provided with a third connection structure and a fourth connection structure, and the third connection structure is The connection structure is adapted to the first connection structure;

Correspondingly, the first connection structure is arranged on the circumferential side of the base, the first connection structure includes an external thread, and the base can be screwed into the fixing member through the external thread;

Correspondingly, the fixing rod is arranged at the central position of the proximal end side of the base, so that when the base is pushed into the fixing part by the fixing rod, the force acting on the base is more uniform and stable, and the first clamping The part and the second clamping part are located on the same diameter on the proximal end side of the base, and the first clamping part and the second clamping part are respectively symmetrical with the fixing rod as the center of symmetry Setting, the distal ends of the fixing rod, the first clamping part and the second clamping part are all arranged on the proximal end side of the base, which can shorten the overall length of the structure;

Correspondingly, the second connection structure includes a threaded hole, and the fixing rod can be quickly connected and disassembled with the push rod through the threaded hole;

Correspondingly, the clamping structure includes a toothed structure, and after the second clamping arm is pushed into the interior of the fixed part along with the base, the toothed structure and the third connection structure on the fixed part are used for clamping to prevent the base from being damaged. The disengagement occurs between the fixed parts to maintain the current fixed state;

Correspondingly, the first clamping arm and the second clamping arm are made of elastic materials, including Nitinol;

Correspondingly, a shaping angle is set between the first clamping arms and between the second clamping arms, and the shaping angle between the first clamping arms is greater than that between the second clamping arms. The included angle is shaped so that the first clamping arm and the second clamping arm can capture the valve tissue, preferably, the angle variation range between the first clamping arm and the central axis of the valve clamp is set to 0°-70° °, the angle difference between the shaping angle between the first clamping arms and the shaping angle between the second clamping arms is 10°-20°;

Correspondingly, the length of the first clamping arm and the second clamping arm is 5.0-12.0 mm, and the width is 3-8 mm;

Correspondingly, the proximal ends of the first clamping arm and the second clamping arm are provided with contacts that cooperate with each other, and the opposite sides of the first clamping arm and the second clamping arm are provided with The cooperating clamping teeth, when clamping, the contacts are pressed against each other to enhance the clamping degree, the clamping teeth can enhance the friction between the clamping arm and the valve tissue, and prevent the clamped valve tissue from slipping out of the clamping arms. ;

Correspondingly, the contacts of the first clamping arms are provided with threading holes, and pulling wires are respectively passed through the threading holes, and the size of the included angle between the first clamping arms is controlled by pulling the pulling wires;

Correspondingly, the contact surfaces of the first clamping arm and the second clamping arm are coated with a polymer film or a polymer material, including a PET film, so as to facilitate the operation of the clamp after implantation into the human body. endothelialization;

Correspondingly, the outer surface of the fastener component is coated with a polymer film or a polymer material, including a PET film, to promote endothelialization after the clip is implanted into the human body;

Correspondingly, the fixing member includes a fixing ring, the fixing ring is a hollow structure, the third connecting structure is provided at the proximal end of the hollow inner side wall of the fixing ring, and the third connecting structure includes an internal thread, and the The inner thread is threadedly connected with the first connection structure;

Correspondingly, the fixing member includes a fixing ring, and the fixing ring is a hollow structure, and a fourth connecting structure is provided at the proximal end of the fixing ring, and the fourth connecting structure includes a connecting arm and an opening on the connecting arm. The connection hole of the duct is used to realize the quick connection and disassembly with the conveying pipe through the connection hole;

Correspondingly, the axial length of the fixing ring is 4.0-10.0 mm, the inner diameter is 4.0-6.0 mm, and the outer diameter is 4.5-7.0 mm.

A valve clamping system, in addition to the aforementioned valve clamping device, also includes:

an adjustable bendable catheter sheath, the bendable catheter sheath includes a proximal straight tube section and a distal end bending section, and the straight tube section and the bending section have a continuous first through hole connecting both ends;

A dilator, the dilator is suitable for passing through the first through hole, the axial length of the dilator is greater than the axial length of the flexible catheter sheath, and the dilator has two ends that communicate with each other. a second through hole, the inner diameter of the second through hole is suitable for penetrating the guide wire;

a loading device, the loading device has a third through hole communicating with both ends, the third through hole is suitable for accommodating the valve clamp and at least a part of the delivery tube, and the outer wall size of at least a part of the third through hole is can enter the first through hole;

a delivery tube adapted to pass through the first through hole, the delivery tube having an axial length greater than the total axial length of the bendable catheter sheath and the loader, and the delivery tube having a fourth through hole communicating with both ends, the distal end of the delivery tube and the proximal end of the fixing member are detachably connected;

a push rod, the axial length of the push rod is greater than the axial length of the conveying pipe, and is suitable for axial movement along the fourth through hole, and the distal end of the push rod has a fifth connection structure, The push rod is detachably connected through the fifth connection structure and the second connection structure of the fixing rod;

Correspondingly, a hemostatic valve is provided at the inner proximal end of the bendable catheter sheath, the dilator, the delivery tube and the loader;

Correspondingly, the delivery tube and the push rod also have elastic sections, and the elastic sections can be bent following the bending of the catheter sheath bending section;

Correspondingly, the distal end of the conveying tube is provided with at least two extension arms, the extension arms are made of elastic material, and the extension arms are shaped into a flared structure, and at least two clips are provided at the inner proximal end of the extension arms. a connector, two of the clips are staggered and arranged on the opposite inner side walls of the extension arm, and the two clips are provided with corresponding holes, and the holes are used for the push rod to pass through;

Correspondingly, the extension arm is also provided with a clamping block, the number and position of the clamping block and the fourth connection structure are corresponding to ensure the detachable connection between the clamping block and the fourth connection structure;

Correspondingly, the fifth connection structure includes a threaded protrusion, and the threaded protrusion is adapted to the second connection structure.

It should be noted that, in the present invention, the concepts of "proximal end" and "distal end" both refer to the judgment based on the relative position between the valve and the operator during normal use during valve surgery. The proximal end refers to the end close to the operator, and the distal end refers to the end away from the operator. The "setting" refers to the shape or angle that the structure presents under the natural structure without external force after the pre-process. natural angle. The "elastic material" refers to a material in which an object is deformed by force, and the object returns to its original shape after the force is removed. The elastic section is elastically deformed under the action of an external force, and can return to its original state by itself after the external force is removed.

The beneficial effects of the present utility model are:

1) The distal end of the first clamping arm, the distal end of the second clamping arm, and the distal end of the fixing rod are all fixed on the base and are located on the same side of the base, so that when implanted in the body, the axial length of the valve clamp is longer. Short, takes up less space, reduces the risk of thrombosis, and reduces the possibility of damage to the heart tissue caused by the valve clamp;

2) The first clamping arm, the second clamping arm, the fixing rod and the base can be set in an integrated manner, the structure is simpler and more stable, and the valve can be captured only by changing the angle of the first clamping arm by pulling the wire. The space is smaller, and the requirement of unilateral or bilateral simultaneous valve capture can be achieved by tightening or loosening the pull wires individually or at the same time;

3) The delivery system can puncture the interatrial septum from the femoral vein into the right atrium, and output from the left atrium, which changes the existing delivery path and makes the surgical trauma smaller;

4) When the valve is captured, the second clamping arm, the base, and the fixing ring are located in the left ventricle, and the first clamping arm is located in the left atrium. The valve tissue can be captured, and the operating range is small, which greatly reduces the risk of damage to the chordae tendineae and the roof of the left atrium;

5) The conveying pipe and the push rod are detachably connected with the fixing ring and the fixing rod respectively, and the connection structure is simple, which makes the connection and disassembly of the two easier.

Description of drawings

Fig. 1 is the schematic diagram of cardiac anatomy;

In the figure: 1 is the superior vena cava, 2 is the inferior vena cava, 3 is the right atrium, 4 is the tricuspid valve, 5 is the right ventricle, 6 is the pulmonary valve, 7 is the pulmonary artery, 8 is the pulmonary vein, 9 is the left atrium, 10 is the mitral valve, 11 is the left ventricle, 12 is the aortic valve, 13 is the aorta, 14 is the descending aorta, 15 is the oxygenated blood flow, and 16 is the hypoxic blood flow;

Figure 2 is a schematic diagram of the surgical mitral valve edge-to-edge suture technique, where 2a is when the mitral valve is closed, and 2b is when the mitral valve is open;

Fig. 3a is a schematic diagram of the front structure of the valve clamp when the pull wire is released according to an embodiment of the present invention;

3b is a schematic side view of the valve clamp according to an embodiment of the present invention in a state where the pull wire is released;

4a is a schematic diagram of the front structure of the valve clamp in a state where the pull wire is tightened according to an embodiment of the present invention;

4b is a schematic side view of the valve clamp in a state where the pull wire is tightened according to an embodiment of the present invention;

Fig. 5a is a schematic diagram of the front structure of the clamping member in a state where the pulling wire is released according to an embodiment of the present invention;

Figure 5b is a schematic top view of the structure of the clamping member in a state where the pull wire is released according to an embodiment of the present invention;

Fig. 6a is a schematic diagram of the front structure of the clamping part in the tightened state of the pull wire according to an embodiment of the present invention;

6b is a schematic side view of the clamping member in the tightened state of the pull wire according to an embodiment of the present invention;

FIG. 7a is a schematic view of the front structure of the fixing ring according to an embodiment of the present invention;

7b is a schematic side view of the fixing ring according to an embodiment of the present invention;

8 is a schematic structural diagram of an adjustable bendable catheter sheath according to an embodiment of the present invention;

9 is a schematic structural diagram of a dilator according to an embodiment of the present invention;

10 is a schematic structural diagram of a loader according to an embodiment of the present invention;

11a is a schematic diagram of the overall structure of the conveying pipe according to an embodiment of the present invention;

11b is an enlarged schematic view of the upper extension arm of the conveying pipe according to an embodiment of the present invention;

Fig. 11c is a schematic diagram of the state in which a push rod is inserted into the conveying pipe according to an embodiment of the present invention;

12a is a schematic structural diagram of a push rod according to an embodiment of the present invention;

Figure 12b is a schematic diagram of the enlarged structure of the distal end of the push rod according to an embodiment of the present invention;

Figure 13 is a schematic diagram of the assembly of the flexible catheter sheath, dilator and guide wire;

Figure 14 is a schematic diagram of the assembly of an adjustable bendable catheter sheath, a delivery tube and a push rod;

The bending diagram of the structure in Figure 8-14 is only to show that it has a bendable property;

In the picture:

20. Base; 201. External thread;

30. Fixed rod; 301. Threaded hole;

40, the first clamping arm; 401, the clamping teeth; 402, the contact; 403, the pulling wire;

50, the second clamping arm; 501, the tooth structure;

60, fixing ring; 601, internal thread; 602, connecting arm; 603, connecting hole;

701, straight pipe section; 702, bending section;

80. Expander;

90. Guide wire;

100. Loader;

110, conveying pipe; 1001, extension arm; 1002, clamping piece; 1003, hole; 1004, clamping block;

120, push rod; 1201, thread protrusion;

130. Hemostatic valve.

Detailed ways

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "Back", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Clockwise", "Counterclockwise" etc. Or the positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, which is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, be constructed and operation, so it cannot be construed as a limitation to the present invention.

In addition, the terms "first" and "second" are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature defined as "first" or "second" may expressly or implicitly include one or more of that feature. In the description of the present invention, "plurality" means two or more, unless otherwise expressly and specifically defined.

In the present utility model, unless otherwise expressly specified and limited, the terms "installation", "connection", "connection", "fixed" and other terms should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

In an embodiment of the present invention, the valve clamping system includes a valve clamp, a flexible catheter sheath, a dilator 80, a loading device 100, a delivery tube 110 and a push rod 120; wherein,

As shown in Figures 3a-6b, the valve clamp includes a clamping part and a fixing part, the clamping part includes a base 20, a fixing rod 30, a first clamping part, and a second clamping part, and the fixing rod is arranged on the base 20 30. The first clamping part and the second clamping part, in this embodiment, the fixing rod 30 is arranged at the central position of the proximal end side of the base 20, and the first clamping part and the second clamping part are located at the proximal end of the base 20 On the same diameter of the side, and the first clamping part and the second clamping part are symmetrically arranged with the fixed rod 30 as the center of symmetry, on the one hand, the stability of the fixed rod 30 can be improved when advancing, on the other hand, the This layout can shorten the overall length of the structure. In this embodiment, in order to facilitate the assembly of the valve clamp, the base 20, the fixing rod 30, the first clamping part and the second clamping part are directly integrated and arranged;

The proximal end of the fixing rod 30 has a second connection structure, and in this embodiment, the second connection structure is set as a threaded hole 301;

The first clamping part has at least two first clamping arms 40 , the second clamping part has a corresponding number of second clamping arms 50 , and each first clamping arm 40 has its corresponding second clamping arm 50 A set of clamps is formed, the first clamping arm 40 and the second clamping arm 50 are made of elastic materials, such as nickel-titanium alloy, and a shaped angle is set between the first clamping arm 40 and the second clamping arm 50, and The shaping angle between the first clamping arms 40 is greater than the shaping angle between the second clamping arms 50 . In this embodiment, the angle variation range between the first clamping arm 40 and the central axis of the clamping device is set to 0° -70°, the angle difference between the shaping angle between the first clamping arm 40 and the shaping angle between the second clamping arm 50 is 10°-20°, so that the first clamping arm 40 and the second clamping arm 40 can Arm 50 can capture valve tissue. The proximal ends of the first clamping arm 40 and the second clamping arm 50 are provided with mutually matched contacts 402, and the opposite sides of the first clamping arm 40 and the second clamping arm 50 are provided with mutually matched clamping teeth 401 , wherein, the contact 402 of the first clamping arm 40 is provided with a threading hole, and a pulling wire 403 is respectively passed through the threading hole, and the proximal end of the pulling wire 403 is connected to the body through the fourth through hole of the conveying tube 110, which is convenient for in vitro Tighten or loosen the cable. In addition, the outer side of the second clamping arm 50 is also provided with a clamping structure. In this embodiment, the clamping structure is set as a toothed structure 501;

The base 20 has a first connection structure. In this embodiment, the first connection structure is an external thread 201, that is, an external thread 201 is provided on the circumferential side of the base 20;

As shown in Figures 7a and 7b, the fixing part and the base 20 are detachably connected. In this embodiment, the fixing part is a fixing ring 60, the fixing ring 60 is a hollow structure, and a third part is arranged at the proximal end of the hollow inner side wall of the fixing ring 60. The connection structure, because the third connection structure and the first connection structure are detachably connected, on the premise that the first connection structure is set as the external thread 201, the third connection structure is set as the internal thread 601. The external thread 201 is adapted to facilitate the base 20 to enter the inner distal end of the fixing ring 60 in a screw manner. As shown in FIG. 4a, as the base 20 is screwed in, the second clamping arm 50 also partially enters the fixing ring 60. At this time, the toothed structure 501 on the outer side of the second clamping arm 50 and the inner thread 601 can also form a running-in effect, so as to prevent the fixing ring 60 from being disengaged after the clamping part is fixed. As shown in Figures 7a and 7b, a fourth connection structure is provided at the proximal end of the fixing ring 60. In this embodiment, the fourth connection structure is provided as a connection arm 602 and a connection hole 603 opened on the connection arm 602;

The adjustable bendable catheter sheath, the dilator 80, the delivery tube 110 and the proximal end of the loader 100 are all provided with a hemostatic valve 130, wherein,

As shown in FIG. 8 , the bendable catheter sheath further includes a proximal straight tube section 701 and a distal end bending section 702, and the straight tube section 701 and the bending section 702 have continuous first through holes connecting both ends. The bending section 702 is a bendable catheter section, which is made of elastic material, and the principle of bending is: through a pulling wire, one end of the pulling wire is fixed to the end of the bending section 702 through a pulling wire ring. At the port, the other end protrudes from the proximal end of the adjustable bendable catheter sheath, and through the elastic operation of the traction wire, the bending degree of the bending section can be adjusted. As for the delivery system of the bendable sheath tube, since the bend adjustment structure and operation of the bendable catheter sheath are already in the prior art, the present utility model will not describe them too much. The utility model adopts the adjustable catheter sheath as the conveying device of the valve clamp. The reason is that because the valve clamp is conveyed from the right atrium to the left atrium, the conveying direction of the valve clamp is inconsistent with the orientation of the mitral valve. , it is necessary to adjust the output direction of the valve clamp to the position of the mitral valve through the adjustment of the bending section 702;

As shown in FIG. 9 , the dilator 80 is suitable for passing through the first through hole, the axial length of the dilator 80 is greater than the axial length of the flexible catheter sheath, and the dilator 80 has a second through hole communicating with both ends , the inner diameter of the second through hole is suitable for penetrating the guide wire 90;

As shown in FIG. 10 , the loader 100 has a third through hole communicating with both ends, the third through hole is suitable for accommodating the valve clamp and at least a part of the delivery tube 110 , and the outer wall of at least a part of the third through hole is dimensioned to enter the first through hole. In the hole, the loader 100 only serves as a transit structure of the valve clamp;

As shown in FIGS. 11a-11c , the delivery tube 110 is adapted to pass through the first through hole, the delivery tube also has an elastic section, and the axial length of the delivery tube 110 is greater than the total axial length of the adjustable bendable catheter sheath and the loader 100 length, and the delivery tube 110 has a fourth through hole connecting the two ends, the distal end of the delivery tube 110 and the fourth connection structure at the proximal end of the fixing ring 60 are detachably connected, since in this embodiment, the fourth connection structure is connected by the connecting arm 602 and the connecting hole 603. Therefore, the distal end of the delivery tube 110 needs to have a connecting structure that is compatible with the connecting hole 603. To achieve this purpose, in this embodiment, the distal end of the delivery tube 110 is provided with at least two extension The arm 1001 is provided with a clamping block 1004 on the extension arm 1001. The number and position of the clamping block 1004 and the connecting hole 603 correspond to ensure that the clamping block 1004 can be inserted into the connecting hole 603 to realize the connection between the conveying pipe 110 and the fixing ring 60. connect. At the same time, it is considered that after the delivery tube 110 transports the fixing ring 60 in place, the connection between the delivery tube 110 and the fixing ring 60 needs to be released. Therefore, under the premise of the aforementioned structure, the extension arm 1001 is made of elastic material, for example, elastic material Including nickel-titanium alloy, spring steel, etc., and the extension arm 1001 is shaped as a flared structure, at least two clips 1002 are arranged at the inner and proximal end of the extension arm 1001, and the two clips 1002 are staggered and placed opposite the extension arm 1001. On the inner side wall, the two clips 1002 are provided with corresponding holes 1003, the holes 1003 are used for the push rod 120 to pass through, so that the extension arm 1001 is connected with the push rod 120 by the clip 1002, so that the two extension arms 1001 is kept at a certain distance, which also ensures that the clamping block 1004 can be stably clamped in the connecting hole 603, but when the connection between the conveying pipe 110 and the fixing ring 60 needs to be removed, the fixing rod 60 is withdrawn from the hole 1003. The connection relationship between the push rod 120 and the conveying pipe 110, the extension arm 1001 restores its finalized shape, and then drives the block 1004 to come out from the connection hole 603 to realize the disassembly work;

As shown in Figures 12a and 12b, the push rod 120 also has an elastic section, and the axial length of the push rod is greater than the axial length of the conveying pipe 110, and is suitable for axial movement along the fourth through hole. The distal end has a fifth connection structure, and the push rod 120 is detachably connected to the second connection structure of the fixing rod 30 through the fifth connection structure. In this embodiment, the second connection structure is a threaded hole 301, so the fifth connection The structure is set as a threaded protrusion 1201, and the threaded protrusion 1201 is matched with the threaded hole 301, and the threaded connection and disassembly of the two are realized by means of a screw.

In addition, it should be noted that, in this embodiment, for the convenience of description, the fixing ring 60 and the conveying pipe 110 and the fixing rod 30 and the pushing rod 120 are all connected by threaded connections, but they are not limited to threaded connections. The connecting end of the ring 60 and the conveying pipe 110, the connecting end of the fixing rod 30 and the pushing rod 120 are provided with connecting holes, and a connecting wire is passed through the connecting hole. When releasing the connection between the two, it is enough to cut the connecting line, or one of the two connected ends is connected by a screw thread, and the other connected two ends are connected by a connecting line. These are just some specific examples. The purpose is to meet the Both can be disassembled inside the heart.

According to the valve clamping system described in this embodiment, the following embodiments can be obtained:

1) Assembly of the push rod 120, the delivery tube 110 and the loader 100: As shown in FIG. 14, the distal end of the push rod 120 inserts the push rod from the proximal end of the delivery tube 110 into the fourth through hole, and then self-delivery The distal end of the tube 110 passes the delivery tube 110 from the proximal end of the loader 100 into the third through hole;

2) Assembling between the base 20 and the fixing ring 60: use the outer thread 201 on the base 20 and the inner thread 601 on the fixing ring 60 to realize the threaded connection between the base 20 and the fixing ring 60;

3) Assembling between the fixing ring 60 and the conveying pipe 110: After matching the position of the clamping block 1004 on the extension arm 1001 of the conveying pipe 110 with the connecting hole 603 on the fixing ring 60, pass through the fourth through hole of the conveying pipe 110 Push the rod 120, and ensure that the push rod 120 passes through the hole 1003 of the clip 1002 at the same time, and the extension arm 1001 in the flared state is narrowed and restricted, so that the clip 1004 is just inserted into the connection hole 603;

4) Assembly between the fixed rod 30 and the push rod 120: continue to push the push rod 120 along the axial direction of the conveying pipe 110 until the threaded protrusion 1201 on the push rod 120 is completely screwed into the threaded hole 301 of the fixed rod 30 ;

5) Introduce the flexible catheter sheath into the left atrium: as shown in Figure 13, first use a puncture tool such as a puncture needle to make the distal end of the guide wire 90 enter the body, continue to guide the distal end of the guide wire 90 into the left atrium, and then Remove the puncture needle, pass the dilator 80 through the first through hole of the flexible catheter sheath, and pass the proximal end of the guide wire 90 from the distal end of the dilator 80 through the second through hole, so that the dilator 80 can Under the guidance of the guide wire 90, the flexible catheter sheath is re-guided into the left atrium (the distal end of the flexible catheter sheath is the bending section 702, the material is relatively soft, the hardness is low, and it cannot directly penetrate the femoral vein, so a head is required. The tapered and rigid dilator 80 is guided, which is a routine operation in medicine), after which the distal end of the guide wire 90 is pulled into the dilator 80, and the guide wire 90 and the dilator 80 are removed from the dilator 80 together. Withdrawable bendable catheter sheath;

6) The transfer operation of the loader 100: the valve clamp is completely received inside the loader 100, and then the distal end of the loader 100 is inserted into the first through hole of the bendable catheter sheath, and the valve is inserted through the loader 100. The clamp is pushed into the first through hole of the adjustable introducer sheath (the reason why the valve clamp is not pushed directly into the adjustable introducer sheath is that the inner proximal end of the adjustable introducer sheath is provided with a hemostatic valve. 130 and other vulnerable parts, and the outer side of the second clamping arm 50 is provided with a toothed structure 501, and the toothed structure 501 is easy to scrape the hemostatic valve 130 and cause damage to the hemostatic valve 130);

7) The valve clamp is delivered to the mitral valve and the valve tissue is captured: the valve clamp is pushed into the left atrium along the flexible catheter sheath, and the bending section 702 of the flexible catheter sheath is operated to bend. In the direction of the mitral valve, the delivery tube 110 and the push rod 120 are bent along with it, and continue to advance, while tightening the pull wire 403 passing through the first clamping arm 40 to ensure the fixing ring 60, the base 20 and the second clamping arm. 50 enters the left ventricle, and at the same time makes at least a part of the first clamping arm 40 in the left atrium, at this time, release the pulling wire 403 (the two pulling wires 403 passing through the two first clamping arms 40 can be tightened separately or loosening, it can also be tightened or loosened at the same time), so that the first clamping arm 40 can be in a natural shape like the second clamping arm 50. In this embodiment, the shaping clip between the first clamping arms 40 The angle difference between the shaping angle and the second clamping arm 50 is 10°-20°, and then the contact 402 and the clamping teeth 401 cooperate to make the first clamping arm 40 and the second clamping arm 50 Better capture of valve tissue;

8) Further clamping of the captured valve tissue: keep the delivery tube 110 at the current position, so that the fixing ring 60 connected to the delivery tube 110 does not move, continue to push the push rod 120, and under the thrust of the push rod 120, the clamping The component is pushed into the inner distal end of the fixing ring 60. Under the action of the ring diameter of the fixing ring 60, the angle between the first clamping arm 40 and the second clamping arm 50 is greatly reduced, which reduces the impact on the valve tissue. The clamping force is greatly increased, and the clamping effect between the toothed structure 501 and the inner thread 601 can be used to prevent the clamping part and the fixing ring 60 from disengaging, so as to maintain the current fixing state;

9) Release the connection state between the push rod 120 and the fixing rod 30, and between the conveying pipe 110 and the fixing ring 60: rotate the push rod 120 in the reverse direction, and rotate the threaded protrusion 1201 of the push rod 120 from the threaded hole 301 of the fixing rod 30 inwardly. After exiting, the conveying pipe 110 is withdrawn. At the same time, after the force of the extending arm 1001 on the restricting conveying pipe 110 is removed, the extending arm 1001 immediately restores its flared structure, and then drives the clamping block 1004 to escape from the connecting hole 603 of the fixing ring 60. Then, the delivery tube 110 and the push rod 120 are withdrawn from the adjustable bendable catheter sheath together, and finally the adjustable bendable catheter sheath can be withdrawn.

It should be noted that the above-mentioned sequence of operation steps is not unique, as long as it is feasible according to industry operation standards or common sense.

The preferred embodiments of the present invention have been described in detail above. It should be understood that those skilled in the art can make many modifications and changes according to the concept of the present invention without creative efforts. Therefore, any technical solutions that can be obtained by those skilled in the art through logical analysis, reasoning or limited experiments on the basis of the prior art according to the concept of the present invention shall fall within the protection scope determined by the claims. .

Claims (22)

1. A valve clamp, characterized in that it comprises a clamping part and a fixing part, the clamping part comprises a base, a fixing rod, a first clamping part, a second clamping part, and the base has a first clamping part. A connection structure, the fixing rod, the first clamping part and the second clamping part are arranged on the base, the proximal end of the fixing rod has a second connection structure, and the first clamping part There are at least two first clamping arms, the second clamping part has a corresponding number of second clamping arms, the outer side of the second clamping arms is provided with a clamping structure, each of the first clamping The arm and its corresponding second clamping arm form a set of clamps, the fixing part and the base are detachably connected, and the inner side and the proximal end of the fixing part are respectively provided with a third connection structure and a fourth connection structure , and the third connection structure is adapted to the first connection structure. 2 . The valve clamp according to claim 1 , wherein the first connecting structure is disposed on the circumferential side of the base, and the first connecting structure comprises an external thread. 3 . 3 . The valve clamp according to claim 1 , wherein the fixing rod is arranged at the center position of the proximal end side of the base, and the first clamping part and the second clamping part are closed. 4 . The parts are located on the same diameter at the proximal end side of the base, and the first clamping parts and the second clamping parts are respectively symmetrically arranged with the fixing rod as the center of symmetry. 4. The valve clamp according to claim 1, wherein the second connection structure comprises a threaded hole. 5 . The valve clamp according to claim 1 , wherein the clamping structure comprises a tooth-shaped structure. 6 . 6 . The valve clamp according to claim 1 , wherein the first clamping arm and the second clamping arm are made of elastic material. 7 . 7 . The valve clamp according to claim 1 , wherein a fixed angle is set between the first clamping arms and between the second clamping arms, and the first clamp The shaping angle between the clamping arms is larger than the shaping angle between the second clamping arms. 8 . The valve clamp according to claim 7 , wherein the angle variation range between the first clamping arm and the central axis of the valve clamp is set to 0°-70°, and the first clamp The angle difference between the shaping angle between the clamping arms and the shaping angle between the second clamping arms is 10°-20°. 9 . The valve clamp according to claim 1 , wherein the length of the first clamping arm and the second clamping arm is 5.0-12.0 mm, and the width is 3-8 mm. 10 . 10 . The valve clamp according to claim 1 , wherein the proximal ends of the first clamping arm and the second clamping arm are provided with contacts that cooperate with each other, and the first clamping arm and the second clamping arm are provided with contacts that cooperate with each other. Opposite sides of a clamping arm and the second clamping arm are provided with cooperating clamping teeth. 11 . The valve clamp according to claim 10 , wherein the contact of the first clamping arm is provided with a threading hole, and a pulling wire is respectively passed through the threading hole. 12 . 12 . The valve clamp according to claim 10 , wherein the contact surfaces of the first clamping arm and the second clamping arm are coated with a polymer film or high polymer film. 13 . molecular materials. 13 . The valve clamp according to claim 1 , wherein the outer surface of the fixing member is coated with a polymer film or a polymer material. 14 . 14 . The valve clamp according to claim 1 , wherein the fixing member comprises a fixing ring, the fixing ring is a hollow structure, and the fixing ring is provided at the proximal end of the hollow inner side wall of the fixing ring. 15 . A third connection structure, the third connection structure includes an inner thread, and the inner thread is screwed with the first connection structure. 15 . The valve clamp according to claim 1 , wherein the fixing member comprises a fixing ring, the fixing ring is a hollow structure, and a fourth connecting structure is provided at the proximal end of the fixing ring, 16 . The fourth connection structure includes a connection arm and a connection hole opened on the connection arm. The valve clamp according to claim 14 or 15, wherein the axial length of the fixing ring is 4.0-10.0mm, the inner diameter is 4.0-6.0mm, and the outer diameter is 4.5-7.0mm . 17. A clamping system for clamping a valve according to any one of claims 1-15, characterized in that it further comprises: an adjustable bendable catheter sheath, the bendable catheter sheath includes a proximal straight tube section and a distal end bending section, and the straight tube section and the bending section have a continuous first through hole connecting both ends; A dilator, the dilator is suitable for passing through the first through hole, the axial length of the dilator is greater than the axial length of the flexible catheter sheath, and the dilator has two ends that communicate with each other. a second through hole, the inner diameter of the second through hole is suitable for penetrating the guide wire; a loading device, the loading device has a third through hole communicating with both ends, the third through hole is suitable for accommodating the valve clamp and at least a part of the delivery tube, and at least a part of the outer wall of the third through hole is dimensioned to enter in the first through hole; a delivery tube adapted to pass through the first through hole, the delivery tube having an axial length greater than the total axial length of the bendable catheter sheath and the loader, and the delivery tube having a fourth through hole communicating with both ends, the distal end of the delivery tube and the proximal end of the fixing member are detachably connected; a push rod, the axial length of the push rod is greater than the axial length of the conveying pipe, and is suitable for axial movement along the fourth through hole, and the distal end of the push rod has a fifth connection structure, The push rod is detachably connected through the fifth connection structure and the second connection structure of the fixing rod. 18 . The valve clamping system according to claim 17 , wherein the flexible catheter sheath, the dilator, the delivery tube and the inner proximal end of the loader are all provided with hemostasis. 19 . valve. 19 . The valve clamping system according to claim 17 , wherein the delivery tube and the push rod also have elastic sections, and the elastic sections can be bent following the bending of the catheter sheath bending section. 20 . 20 . The valve clamping system according to claim 17 , wherein at least two extension arms are provided at the distal end of the delivery tube, the extension arms are made of elastic materials, and the extension arms are shaped to expand 21 . At least two clamping pieces are arranged at the inner proximal end of the extension arm, the two clamping pieces are staggered and arranged on the opposite inner side walls of the extension arm, and the two clamping pieces are provided with corresponding holes. 21. A valve clamping system according to claim 20, characterized in that: the extension arm is further provided with a blocking block, and the blocking block corresponds to the number and position of the fourth connecting structure, ensuring that The clamping block and the fourth connection structure are detachably connected. 22 . The valve clamping system according to claim 17 , wherein the fifth connecting structure comprises a threaded protrusion, and the threaded protrusion is adapted to the second connecting structure. 23 .

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