Valve repair devices

Abstract

The present application provides a valve repair device, which includes a leaflet capture component and a suture puncture component. The leaflet capture component includes a first clamp, a second clamp and a transmission component. Through the transmission of the transmission component, the second clamp can be opened relative to the first clamp to form an angle, or closed to capture the leaflet of the clamped valve between the first clamp and the second clamp. The suture puncture component includes a puncture needle and a suture that can be pushed and accommodated in the puncture needle. The first clamp is provided with a guide groove. After the leaflet capture component captures the clamped leaflet, the puncture needle passes through the guide groove and punctures the leaflet, and the suture is pushed out of the puncture needle to the other side of the leaflet.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a valve repair device. Background Art

[0002] The atrioventricular valves such as the mitral valve and tricuspid valve are one-way valves in the heart. Normal and healthy atrioventricular valves can control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. Figure 1 As shown, the mitral valve MV is a one-way valve located between the left atrium LA and the left ventricle LV of the heart, which can control the blood flow from the left atrium LA to the left ventricle LV, and prevent blood from flowing from the left ventricle LV to the left atrium LA; the tricuspid valve TV is a one-way valve located between the right atrium RA and the right ventricle RV of the heart, which can control the blood flow from the right atrium RA to the right ventricle RV, and prevent blood from flowing from the right ventricle RV to the right atrium RA.

[0003] See Figure 2 A normal and healthy mitral or tricuspid valve has multiple chordae tendineae L. Taking the mitral valve as an example, the mitral valve leaflets are divided into anterior leaflet and posterior leaflet. When the left ventricle is in diastole, both are in open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in contraction, the chordae tendineae are stretched to ensure that the leaflets are not washed to the atrial side by the blood flow, and the anterior and posterior leaflets are well closed, thereby ensuring that blood flows from the left ventricle through the aortic valve to the aorta. If there is a lesion in the chordae tendineae or papillary muscles, such as Figure 3 The chordae tendineae of the posterior leaflet shown in the figure are ruptured. When the left ventricle is in a contracted state, the mitral valve cannot return to a closed state as in a normal state. The force of blood flow will further cause the valve leaflet to dislocate into the left atrium, causing blood reflux.

[0004] Chordae tendineae cannot repair themselves after they become diseased or ruptured. Even if a few chordae rupture, the tension of other chordae can increase, leading to new ruptures. Currently, chordalopathy is usually treated by surgical suture implantation, or by replacing native chordae with sutures. This requires invasive thoracotomy, general anesthesia, and moderate hypothermia with extracorporeal circulation as auxiliary support. This type of surgery has drawbacks such as complex surgical procedures, high surgical costs, high levels of patient trauma, high risk of complications, long hospital stays, and a painful recovery process for patients.

[0005] There is currently an instrument that implants sutures in a minimally invasive manner. The instrument clamps the leaflets with distal and proximal clamps. During the process of capturing the leaflets, the clamping surface of the capture clamp is at a specific design angle and cannot be adjusted, which makes capturing the leaflets difficult, the surgical operation is cumbersome, and the risk of surgical failure is high. Moreover, after the capture clamp supports the leaflets, the clamp needs to be axially retracted to clamp the leaflets. At this time, as the leaflets beat, the capture clamp and the leaflets are easily separated, making capture difficult. In addition, when the capture clamp is retracted, it is in a "hook shape", which leads to the risk of hooking the chordae tendineae and the leaflets during the retraction process, affecting the surgical operation. Summary of the Invention

[0006] The technical problem to be solved by the present application is to provide a valve repair device that changes the existing capture and puncture methods of the valve leaflets during suture implantation.

[0007] In order to achieve the above objectives, the embodiments of the present application adopt the following technical solutions:

[0008] A valve repair device, comprising:

[0009] A leaflet capture assembly, comprising a first clamping member, a second clamping member, and a transmission assembly, wherein the second clamping member can be opened relative to the first clamping member to form an angle, or closed to capture and clamp the leaflets of the valve between the first clamping member and the second clamping member through transmission by the transmission assembly; and

[0010] The suture puncture assembly includes a puncture needle and a suture accommodated in the puncture needle that can be pushed. The first clamping member is provided with a guide groove. After the leaflet capture assembly captures and clamps the leaflet, the puncture needle passes through the guide groove and punctures the leaflet, and the suture is pushed out of the puncture needle to the other side of the leaflet.

[0011] In a preferred embodiment, the facing surfaces of the first clamping member and the second clamping member are both provided with a clamping area and a non-clamping area, and the clamping area of ​​at least one of the first clamping member and the second clamping member is provided with clamping teeth to provide clamping force to the leaflet, and the guide groove is connected to the non-clamping area of ​​the first clamping member. When the first clamping member and the second clamping member are relatively closed, there is a gap between the non-clamping areas of the first clamping member and the second clamping member to accommodate a part of the leaflet that is not clamped.

[0012] In a preferred embodiment, the first clamping member and the second clamping member are respectively provided with a connecting portion, the connecting portion is located on the side of the clamping area away from the non-clamping area, the connecting portion of the second clamping member is hinged to the connecting portion of the first clamping member, and one end of the transmission assembly is connected to the connecting portion of the second clamping member to drive the second clamping member to open and close relative to the first clamping member.

[0013] In a preferred embodiment, a transmission channel is provided in the first clamping member, the transmission channel is communicated with the clamping area of ​​the first clamping member and extends to the connecting portion, the transmission assembly includes a transmission shaft and a transmission connecting member, the transmission shaft is movably accommodated in the transmission channel, one end of the transmission connecting member is pivotally connected to the second clamping member through a first pivot shaft, and the other end of the transmission connecting member is movably accommodated in the transmission channel and is pivotally connected to one end of the transmission shaft through a second pivot shaft.

[0014] In a preferred embodiment, the first clamping member is a block-shaped base, the second clamping member is a sheet-shaped cover, and the connecting portion of the second clamping member has two ribs arranged relatively spaced apart, and one end of the two ribs away from the clamping area is hinged to the two sides of the connecting portion of the first clamping member through a rotating shaft, and one end of the two ribs close to the clamping area is pivotally connected to the transmission connecting member through the first pivot shaft.

[0015] In a preferred embodiment, the clamping areas of the first clamping member and the second clamping member are both provided with a plurality of clamping teeth, and there is a tooth groove between two adjacent clamping teeth. When the first clamping member and the second clamping member do not clamp the leaflet and are relatively closed, the clamping teeth of the first clamping member engage with the tooth grooves of the second clamping member, and the plurality of clamping teeth extend laterally from one side of the clamping area to the other side of the clamping area respectively. The transmission channel has an opening in the clamping area of ​​the first clamping member, and the opening interrupts part of the clamping teeth of the first clamping member.

[0016] In a preferred embodiment, a limiting boss is provided at the connection between the transmission channel and the connection portion, and the limiting boss is used to limit the transmission connection member to limit the maximum angle of the second clamping piece relative to the first clamping piece.

[0017] In a preferred embodiment, the transmission channel includes a curved section, the limiting boss is located at the end position of the curved section at the connecting portion, the transmission connecting member includes a curved portion and a straight portion connected to the curved portion, the curved portion has a rounded corner near the bottom surface of the curved section, the surface of the curved portion facing away from the curved section has an arc surface, the surface of the straight portion connected to the arc surface is a straight surface, at least a portion of the arc surface is located at the second clamping member, and at least a portion of the straight portion is located at the first clamping member.

[0018] In a preferred embodiment, the transmission channel also includes a straight section connecting the curved section, at least a portion of the straight portion is located in the straight section, and the curved section is composed of an arc segment, an oblique line segment, or a combination of an arc segment and an oblique line segment, and is inclined upward relative to the straight section, so that at least a portion of the curved portion is located between the first clamping member and the second clamping member.

[0019] In a preferred embodiment, the non-clamping areas of the first clamping member and the second clamping member are respectively inclined relative to the clamping area, and the non-clamping areas of the first clamping member and the second clamping member are parallel to each other, and the non-clamping areas of the second clamping member are provided with a limiting groove penetrating the second clamping member and open at one end toward the end direction, the limiting groove is aligned with and lower than the guide groove, and the puncture needle punctures the leaflet in the limiting groove.

[0020] In a preferred embodiment, the length of the non-clamping areas of the first clamping member and the second clamping member from the distal end to the proximal end is between 2-5 mm, the gap between the non-clamping areas of the first clamping member and the second clamping member is between 0.5-2 mm, and the length of the clamping areas of the first clamping member and the second clamping member from the distal end to the proximal end is between 3-5 mm.

[0021] In a preferred embodiment, the non-clamping areas of the first clamping member and the second clamping member have an inclination angle A relative to the corresponding clamping areas, the guide groove includes an inclination section adjacent to the non-clamping area of ​​the first clamping member, the inclination section has an inclination angle B relative to the inclination starting point of the guide groove in the first clamping member, and the angle C of the puncture needle puncturing the leaflet satisfies C=A+B.

[0022] In a preferred embodiment, the inclination angle A of the non-clamping area is between 45-70 degrees, the inclination angle B of the guide groove is between 0-20 degrees, and the angle C of the puncture needle puncturing the leaflet is between 45-90 degrees.

[0023] In a preferred embodiment, an open groove is formed on a surface of the first clamping member facing away from the second clamping member, and the open groove is used to observe the connection status of the transmission shaft and the transmission connecting member.

[0024] In a preferred embodiment, the first clamping member is further provided with a radiographic channel, which is communicated with the non-clamping area and is used for introducing a contrast agent. The radiographic channel is located below the guide groove.

[0025] In a preferred embodiment, when the valve leaflet is not clamped between the first clamping member and the second clamping member and the contrast agent flowing out of the imaging channel is observed under medical imaging, the imaging channel is further used as a blood withdrawal channel.

[0026] In a preferred embodiment, the end of the first clamping member away from the second clamping member has a cylindrical end and a connector, the non-clamping area of ​​the first clamping member is formed on the side of the cylindrical end facing the second clamping member, and the connector is formed on the other side of the cylindrical end, the guide groove, the transmission channel and the radiography channel extend from the connector through the cylindrical end to the side of the non-clamping area, the guide groove is in an open state at the connector, and the connector is used to connect a delivery catheter.

[0027] The present application also provides a valve repair device, comprising:

[0028] An opening and closing control assembly, the opening and closing control assembly comprising a transmission connecting member and a transmission shaft driving the transmission connecting member;

[0029] a leaflet capture assembly, the leaflet capture assembly comprising a first clamping member and a second clamping member, the second clamping member being connected to the transmission connector, the second clamping member being capable of opening relative to the first clamping member to form an angle, or closing to capture and clamp the leaflets of the valve between the first clamping member and the second clamping member; and

[0030] An artificial chord implant component, which punctures the leaflet and pushes the artificial chords to the other side of the leaflet after the leaflet capture component captures and clamps the leaflet. The leaflet capture component is separated from the leaflet and withdrawn after the artificial chord implant component pushes the artificial chords to the other side of the leaflet.

[0031] The valve repair device provided by the present invention has the following beneficial effects:

[0032] One of the clamping members of the leaflet capture assembly of the valve repair device can open relative to the other to form an angle or close to clamp the leaflet between the two. The relative opening angle of the two clamping members can be controlled and adjusted, and when the clamping position is inappropriate, the two can be reopened and closed relative to each other; the suture can be implanted as an artificial chordae to the other side of the leaflet, and can also be used as a suture for repairing the valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 This is a schematic diagram of the mitral and tricuspid valves in their normal state;

[0034] Figure 2 is a schematic diagram of normal chordae tendineae in the heart;

[0035] Figure 3 is a schematic diagram of a ruptured chordae tendineae in the heart;

[0036] Figure 4 is a partial schematic diagram of the valve repair device provided by the first embodiment of the present invention;

[0037] Figure 5 yes Figure 4 A schematic diagram of the second clamping member of the leaflet capture assembly of the valve repair device being opened relative to the first clamping member;

[0038] Figure 6 yes Figure 5 Explosion diagram of

[0039] Figure 7 yes Figure 6 An enlarged schematic diagram of the first clamping member in FIG;

[0040] Figure 8 yes Figure 6 an enlarged schematic diagram of the second clamping member in FIG;

[0041] Figure 9 yes Figure 6 An enlarged schematic diagram of the transmission assembly in FIG.

[0042] Figure 10 yes Figure 7 a schematic back plan view of the first clamping member;

[0043] Figure 11 yes Figure 4 A schematic diagram illustrating the length and gap of a non-clamping area of ​​a leaflet capture component of a valve repair device;

[0044] Figure 12 yes Figure 4 A schematic diagram showing the length of a clamping area of ​​a leaflet capture component of a valve repair device;

[0045] Figure 13 yes Figure 4 A partial top view of a valve repair device;

[0046] Figure 14 yes Figure 4 A schematic diagram showing the puncture angle of the puncture needle of the valve repair device and the inclination angle of the non-clamping area of ​​the first clamping member;

[0047] Figure 15 yes Figure 14 A cross-sectional view of the first clamping member along the central axis of the guide groove;

[0048] Figure 16 yes Figure 7 A schematic diagram of the first clamping member from another angle;

[0049] Figure 17 yes Figure 4 Schematic diagram of a delivery catheter for a valve repair device;

[0050] Figure 18 yes Figure 4 A schematic diagram of a valve repair device including an operating handle;

[0051] Figure 19 yes Figure 18 A partial cross-sectional view of the valve repair device at the operating handle;

[0052] Figure 20 yes Figure 18 A schematic diagram of the valve repair device after removing the housing, operating button and suture implant assembly from the operating handle;

[0053] Figure 21 yes Figure 20 A partial cross-sectional view showing a puncture needle of a valve repair device further extending to a leaflet capture component;

[0054] Figure 22 is a partial three-dimensional schematic diagram of a valve repair device provided by a second embodiment of the present invention;

[0055] Figure 23 yes Figure 22 an enlarged perspective schematic diagram of the first clamping member;

[0056] Figure 24 yes Figure 22 an enlarged perspective schematic diagram of the second clamping member;

[0057] Figure 25 yes Figure 22 A schematic diagram of a valve repair device in a state where the second clamping member is closed relative to the first clamping member when the valve leaflet is not clamped;

[0058] Figure 26 This is a schematic diagram of a valve repair device provided by an embodiment of the present invention, wherein the first bending adjustment sheath and the second bending adjustment sheath are loaded to deliver the valve leaflet capture component to the heart tissue;

[0059] Figure 27 yes Figure 26 A schematic diagram of a state in which the second clamping member of the leaflet capturing assembly of the valve repair device is opened relative to the first clamping member to form a clamping angle;

[0060] Figure 28 yes Figure 27 A schematic diagram of a state in which a leaflet capture component of a valve repair device is aligned with a leaflet;

[0061] Figure 29 yes Figure 28 A schematic diagram of a valve leaflet capture component of a valve repair device clamping a valve leaflet;

[0062] Figure 30 yes Figure 28 An enlarged schematic diagram of the valve repair device when the leaflets initially fall between the leaflet capture components;

[0063] Figure 31 yes Figure 29 An enlarged schematic diagram of the valve repair device puncturing the valve leaflet after the leaflet capture component is closed. DETAILED DESCRIPTION

[0064] In order to make the purpose, technical solutions and advantages of this application clearer, this application will be further described in detail below with reference to the accompanying drawings.

[0065] It should be understood that expressions such as "including" and "may include" used in this application indicate the existence of the disclosed functions, operations, or constituent elements, and do not limit one or more additional functions, operations, and constituent elements. In this disclosure, terms such as "including" and / or "having" may be interpreted as indicating specific characteristics, numbers, operations, constituent elements, components, or combinations thereof, but may not be interpreted as excluding the existence or possibility of adding one or more other characteristics, numbers, operations, constituent elements, components, or combinations thereof.

[0066] In addition, in this application, the expression "and / or" includes any and all combinations of the associated listed words. For example, the expression "A and / or B" may include A, may include B, or may include both A and B.

[0067] In this application, expressions including ordinal numbers such as "first" and "second" may modify various elements. However, such elements are not limited by the above expressions. For example, the above expressions do not limit the order and / or importance of the elements. The above expressions are only used to distinguish one element from other elements. Similarly, without departing from the scope of this disclosure, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element.

[0068] When a component is referred to as being "connected" or "accessed" to another component, it should be understood that the component is not only directly connected to or accessed to the other component, but also that another component may exist between the component and the other component. On the other hand, when a component is referred to as being "directly connected to" or "directly accessed" to another component, it should be understood that no component exists between them.

[0069] In the field of interventional medical device technology, the direction closest to the operator is generally defined as proximal, and the direction away from the operator is defined as distal. The direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction. The circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius).

[0070] See also Figure 4 and Figure 5The valve repair device 100 provided in the first embodiment of the present application includes a leaflet capture assembly 10 and a suture implantation assembly 20. The leaflet capture assembly 10 includes a first clamping member 11, a second clamping member 12, and a transmission assembly 13. Through the transmission assembly 13, the second clamping member 12 can be opened to a certain angle relative to the first clamping member 11, or closed to capture and clamp the leaflet between the first clamping member 11 and the second clamping member 12.

[0071] In this embodiment, the first clamping member 11 is a block-shaped base, and the second clamping member 12 is a sheet-shaped member covering the first clamping member 11. One end of the first clamping member 11 is connected to the delivery conduit 16. The second clamping member 12 is hinged to the first clamping member 11. The transmission assembly 13 is located between the first clamping member 11 and the second clamping member 12. One end of the transmission assembly 13 is connected to the second clamping member 11, and the other end is movable and driven within the first clamping member 11.

[0072] For details, please refer to Figures 6 to 9 The first clamping member 11 is provided with a connecting portion 112, a clamping area 114, and a non-clamping area 116 from the distal end away from the operator to the proximal end close to the operator; the second clamping member 12 is provided with a connecting portion 122, a clamping area 124, and a non-clamping area 126 from the distal end away from the operator to the proximal end close to the operator. The clamping area 114 of the first clamping member 11 faces the clamping area 124 of the second clamping member 12, and the non-clamping area 116 of the first clamping member 11 faces the non-clamping area 126 of the second clamping member 12. When the first clamping member 11 and the second clamping member 12 are relatively closed, there is a gap between the non-clamping areas 126 of the first clamping member 11 and the second clamping member 12 (see Figure 11 ).

[0073] At least one of the clamping area 114 of the first clamping member 11 and the clamping area 116 of the second clamping member 12 is provided with clamping teeth to provide a clamping force on the leaflet. In this embodiment, the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12 are each provided with clamping teeth, and a tooth groove is formed between two adjacent clamping teeth. When the first clamping member 11 and the second clamping member 12 are relatively closed, the clamping teeth 110 of the first clamping member 11 engage with the tooth groove 121 of the second clamping member 12, and the tooth groove 111 of the first clamping member 11 engages with the clamping teeth 120 of the second clamping member 12.

[0074] The clamping teeth 110 of the first clamping member 11 and the clamping teeth 120 of the second clamping member 12 are both arranged side by side laterally along the surface of the clamping area, and both extend from one side to the other side of the clamping area.

[0075] The connecting portion 122 of the second clamping member 12 has two ribs 122a spaced apart from each other. The connecting portion 112 of the first clamping member 11 is block-shaped. The two ribs 122a have an axial hole 122d at one end away from the clamping area 124. The ribs 122a are then hinged to the axial holes 112a on both sides of the connecting portion 112 of the first clamping member 11 via a rotating shaft 122b. In this way, the second clamping member 12 can be rotated relative to the first clamping member 11 to open or close. The two ribs 122a are inclined relative to the clamping area 124 toward the first clamping member 11. The two side edges of the connecting portion 112 of the first clamping member 11 have inclined support portions 112b. When the first and second clamping members 11 and 12 are not clamping the leaflets and are relatively closed, the two ribs 122a are precisely accommodated on the support portions 112b, making the entire leaflet capture assembly 10 smaller in size.

[0076] The first clamping member 11 has a transmission channel 115 extending from its proximal end to its distal end. The transmission channel 115 communicates with the clamping region 114 and has an opening in the clamping region 114 that extends to the connecting portion 112 and interrupts a portion of the clamping teeth 110. The transmission channel 115 includes a curved segment 115b near the distal end and a straight segment 115a connecting the curved segment 115b and near the proximal end. The curved segment 115b is composed of an arc segment, an oblique segment, or a combination of an arc segment and an oblique segment. The curved segment 115b is inclined upward relative to the straight segment 115a, toward the second clamping member 12.

[0077] The transmission assembly 13 includes a transmission shaft 132 and a transmission connector 134. The transmission shaft 132 is movably received in the transmission channel 115. Specifically, a first end of the transmission shaft 132 is located within the transmission channel 115 of the first clamping member 11, and an opposite second end extends beyond the proximal end of the first clamping member 11. The portion of the transmission shaft 132 extending beyond the proximal end of the first clamping member 11 is sheathed with a spring tube 132b, allowing the transmission shaft 132 to move within the spring tube 132b without interference.

[0078] The first end of the transmission connecting member 134 is pivotally connected to the second clamping member 12 on the first pivot axis 134a, and the second end thereof is movably accommodated in the transmission channel 115 and pivotally connected to the first end of the transmission shaft 132 on the second pivot axis 134b through the shaft hole 132a. Figure 10 An open groove 130 is provided on the surface of the first clamping member 11 facing away from the second clamping member 12. The open groove 130 is used to observe the connection status of the transmission shaft 132 and the transmission connecting member 134, including whether the connection is in place and whether there are any abnormalities.

[0079] Because the connecting portion 122 of the second clamping member 12 is composed of two spaced-apart ribs 122a, the first end of the transmission connector 134 is provided with a connecting post 134c. This post 134c defines an axial hole 134d. The post 134c is then pivotally connected to the axial holes 122c located at the ends of the two ribs 122a near the clamping region 124 via a first pivot axis 134a. The second end of the transmission connector 134 is pivotally connected to the first end of the transmission shaft 132 via a second pivot axis 134b. "Pivoting" here refers to the ability of two pivoted objects to have at least one degree of rotational freedom relative to the pivot axis. In this embodiment, the transmission connector 134 can rotate about the first pivot axis 134a, and the second pivot axis 134b. Both the first pivot axis 134a and the second pivot axis 134b can be pins, with the second clamping member 12, the transmission connector 134, and the transmission shaft 132 being mounted around the pins via their axial holes. The transmission of the transmission shaft 132 drives the transmission connector 134 to move, and the movement of the transmission connector 134 causes the second clamping member 12 to rotate around the hinged first clamping member 11, thereby opening and closing relative to the first clamping member 11. In this way, the transmission component 13 also becomes an opening and closing control element of the leaflet capture component 10.

[0080] The transmission connector 134 includes a curved portion 134a and a straight portion 134e connecting the curved portion 134a. The bottom surface of the curved portion 134a adjacent to the curved section 115b of the transmission channel 115 has a rounded corner 134c. The surface of the curved portion 134a facing away from the curved section 115b has an arcuate surface 134d. The arcuate surface 134d curves from the connecting post 134c. Because the connecting post 134c is connected to the second clamping member 12, at least a portion of the arcuate surface 134d is located on the second clamping member 12. The upper surface 134f of the straight portion 134e connecting to the arcuate surface 134d is a straight surface, and the lower surface connecting to the rounded corner 134c is also a straight surface. At least a portion of the straight portion 134e is located on the first clamping member 11. As the transmission assembly 13 moves, at least a portion of the straight portion 134e moves along the straight section 115a of the transmission channel 115. Because the curved section 115b of the transmission channel 115 is inclined upward relative to the straight section 115a toward the second clamping member 12, at least a portion of the curved portion 134a is located between the first clamping member 11 and the second clamping member 12.

[0081] In this embodiment, a limiting boss 115d is formed at the point where the curved section 115b of the transmission channel 115 connects to the connecting portion 112, i.e., at the end of the curved section 115b. The limiting boss 115d is designed so that when the second clamping piece 12 is opened to the maximum angle relative to the first clamping piece 11, the limiting boss 115d just limits the transmission connector 134. That is, at this time, the drive device of the transmission shaft 132 can no longer drive the transmission shaft 132 and its connected transmission connector 134 to cross the limiting boss 115d. At this time, the rounded corner 134c on the bottom surface of the curved portion 134a can just be tangent to the edge line of the limiting boss 115d. The maximum angle that the second clamping piece 12 can open relative to the first clamping piece 11 can be 60 degrees, or it can be designed to open 90 degrees. Generally, for clamping a single leaflet, the second clamping piece 12 only needs to be opened 60 degrees relative to the first clamping piece 11.

[0082] The non-clamping area 116 of the first clamping member 11 is formed as a whole into an inclined surface, sloping from the clamping area 114 toward the proximal end. The non-clamping area 126 of the second clamping member 12 is also formed as a whole into an inclined surface, sloping from the clamping area 124 toward the proximal end. The non-clamping area 116 of the first clamping member 11 is oriented toward and parallel to the non-clamping area 126 of the second clamping member 12. In other embodiments, the non-clamping areas 116 and 126 may also be partially inclined and parallel.

[0083] See also Figure 11 and Figure 12 , the length L31 of the clamping area 114 of the first clamping member 11 from the distal end to the proximal end and the length L32 of the clamping area 124 of the second clamping member 12 from the distal end to the proximal end are respectively between 3-5 mm, and the length L31 of the clamping area 114 and the length L32 of the clamping area 124 can be equal or unequal. The length L11 of the non-clamping area 116 of the first clamping member 11 from the distal end to the proximal end and the length L12 of the non-clamping area 126 of the second clamping member 12 from the distal end to the proximal end are respectively between 2-5 mm. The length L12 of the non-clamping area 126 can be slightly larger than the length L11 of the non-clamping area 116, so that when the second clamping member 12 is closed on the surface of the first clamping member 11, the top of the non-clamping area 126 is higher than the top of the non-clamping area 116, which is beneficial to prevent the movable second clamping member 12 from being hit by the delivery sheath and moving open during the delivery process. The gap L2 between the non-clamping area 116 of the first clamping member 11 and the non-clamping area 126 of the second clamping member 12, that is, the gap L2 between the inclined surfaces, is between 0.5-2 mm to accommodate the thickness of the heart valve leaflet.

[0084] When the first clamping member 11 and the second clamping member 12 are closed, they have a clamping force on the leaflet. The clamping teeth 110 of the first clamping member 11 and the clamping teeth 120 of the second clamping member 12 make the clamping more stable. The non-clamping area 116 of the first clamping member 11 and the non-clamping area 126 of the second clamping member 12 have no clamping force on the leaflet, but have a certain supporting effect.

[0085] In this embodiment, please refer to Figure 8 A convex part 125 is protruded between the clamping area 124 and the connecting part 122 of the second clamping member 12, and the height of the convex part 125 is higher than the height of the clamping tooth 120. A groove 119 is provided between the clamping area 114 and the connecting part 112 of the first clamping member 11, and the transmission channel 115 is in the opening interruption part of the groove 119 of the clamping area 114. When the leaflet is not clamped between the first clamping member 11 and the second clamping member 12 and is relatively closed, the convex part 125 is accommodated in the groove 119. When leaflets are present between the convex component 125 and the groove 119, the first clamping member 11 and the second clamping member 12 cannot completely close. Thus, the convex component 125 can be used as a detection mark to detect whether the leaflets are clamped in the proper position. For example, if it is found that the first clamping member 11 and the second clamping member 12 cannot close, it may be due to excessive leaflets being accumulated between the convex component 125 and the groove 119. In this case, the first clamping member 11 and the second clamping member 12 of the leaflet capture assembly 10 can be reopened so that the leaflets fall primarily between the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12. The accumulation of excessive leaflets between the convex component 125 and the groove 119 can also be observed through medical imaging of the surgical procedure. The height of the convex component 125 is higher than that of the clamping teeth 120, making it easily recognizable in medical imaging. The depth of the groove 119 can be less than the sum of the thickness of the convex part 125 and the leaflet. Therefore, when leaflets are accumulated between the convex part 125 and the groove 119, the convex part 125 cannot be completely accommodated in the groove 119, that is, the first clamping member 11 and the second clamping member 12 cannot be completely closed when closed.

[0086] The above-mentioned convex part 125 is preferably a trihedron or a tetrahedron so as to have better recognition under medical images. Of course, it can also be a cylindrical shape, etc. The positions of the convex part 125 and the groove 119 can also be interchanged, that is, the convex part 125 is set on the first clamping part 11, and the groove 119 is set on the second clamping part 12.

[0087] Please refer again Figure 7The first clamping member 11 is also provided with an angiography channel 140, which is connected to the non-clamping area 116 and is used to introduce contrast agent. When the leaflet is not clamped between the first clamping member 11 and the second clamping member 12, the contrast agent flowing out of the angiography channel 140 can be observed under medical images, such as digital subtraction angiography (DSA) rays. When the leaflet is clamped between the first clamping member 11 and the second clamping member 12, the angiography channel 140 will be covered or blocked by the leaflet, so that it can be seen that a leaflet falls between the first clamping member 11 and the second clamping member 12. Furthermore, when contrast agent is observed flowing out of the angiography channel 140, the leaflets are not clamped, and the angiography channel 140 can be used to withdraw blood from the surgery, thereby serving as a blood withdrawal channel. When the angiography channel 140 is covered or blocked, preventing injection of contrast agent, it indicates that the leaflets are clamped, and it is recommended that blood withdrawal is no longer performed. In this embodiment, the angiography channels 140 include two, both located below the non-clamping area 116.

[0088] After the capture assembly 10 of the valve repair device 100 of the embodiment of the present invention captures the valve leaflet, the suture implantation assembly 20 implants sutures into the captured valve leaflet. The suture implantation assembly 20 punctures the valve leaflet with a puncture needle and then pushes the suture from the inside of the puncture needle to the outside to reach the other side of the valve leaflet.

[0089] Please also refer to Figure 8 and Figure 13 , the first clamping member 11 is provided with a guide groove 117, the guide groove 117 is connected to the non-clamping area 116 of the first clamping member 11, and has an opening in the non-clamping area 116. In this embodiment, the guide groove 117 is located above the non-clamping area 116, and the non-clamping area 126 of the second clamping member 12 is provided with a limiting groove 127 that penetrates the second clamping member 12 and is open at one end in the proximal direction, that is, in the distal direction of the second clamping member 12. When the second clamping member 12 and the first clamping member 11 are closed, the limiting groove 127 is lower than the guide groove 117 and is aligned with the guide groove 117 (see Figure 13 ), and the width or diameter D2 of the limiting groove 127 is greater than the diameter D1 of the puncture needle, so that the puncture needle can pass through the limiting groove 127. The limiting groove 127 has a certain capacity for the leaflets, preventing the puncture needle from slipping when puncturing the leaflets. The puncture needle has a specific needle tip, and the needle tip is optimally positioned at the midpoint of the limiting groove 127 when puncturing the leaflets. Alternatively, if two-thirds of the area of ​​the puncture needle is accommodated by the limiting groove 127, the needle tip can puncture the leaflets, preventing the needle from slipping and ensuring stable puncture.

[0090] like Figure 14and Figure 15 As shown, the non-clamping area 126 of the second clamping member 12 has an inclination angle A relative to the clamping area 124. The non-clamping area 116 of the first clamping member 11 is parallel to the non-clamping area 126 of the second clamping member 12, so the non-clamping area 116 of the first clamping member 11 also has an inclination angle A relative to the clamping area 114. The guide groove 117 includes an inclined section 117a adjacent to the non-clamping area 116 of the first clamping member 11. The inclined section 117a is tilted upward relative to the starting point of the guide groove 117 within the first clamping member 11, forming an inclination angle B relative to the starting point. This inclination angle B appropriately raises the needle exit angle. When the puncture needle punctures the leaflet, the angle C between the needle tip and the leaflet satisfies C = A + B. Preferably, the inclination angle A of the non-clamping area 116 is between 45 and 70 degrees, the inclination angle B of the guide groove 117 is between 0 and 20 degrees, and the angle C at which the puncture needle punctures the leaflet is between 45 and 90 degrees. In this embodiment, the inclination angle A of the non-clamping area 116 is 70 degrees or close to 70 degrees, the inclination angle B of the guide groove 117 is 20 degrees or close to 20 degrees, and the angle C at which the puncture needle punctures the leaflet is 90 degrees or close to 90 degrees, that is, the puncture needle is in a state of substantially vertically puncturing the leaflet, which helps prevent the needle from slipping during puncture and prevents the needle from slipping and injuring the leaflet, causing secondary damage to the leaflet.

[0091] See also Figure 16 The end of the first clamping member 11 away from the second clamping member 12, that is, the proximal end of the first clamping member 11 has a connector 150, and the guide groove 117, the transmission channel 115 and the imaging channel 140 extend from the connector 150 to one side of the non-clamping area 116. The connector 150 is used to connect to the delivery catheter 16 (see Figure 13 ).

[0092] Specifically, the proximal portion of the first clamping member 11 has a cylindrical end 150a, the non-clamping area 116 of the first clamping member 11 is formed on the side of the cylindrical end 150a facing the second clamping member 12, and the connector 150 is formed on the other side of the cylindrical end 150a. The top of the cylindrical end 150a is the highest point of the first clamping member 11. When the second clamping member 12 and the first clamping member 11 are closed, the top of the cylindrical end 150a is higher than the top of the second clamping member 12. This is beneficial for preventing the movable second clamping member 12 from being hit by the delivery sheath during delivery. The connector 150 is recessed downward relative to the cylindrical end 150a for being used to be sleeved onto the delivery catheter 16. After the delivery catheter 16 is sleeved onto the connector 150, the delivery catheter 16 is substantially flush with the surface of the cylindrical end 150a. The guide groove 117, transmission channel 115, and imaging channel 140 extend from the connector 150 through the cylindrical end 150a toward one side of the non-clamping area 116. The transmission channel 115 and the two imaging channels 140 are formed as through holes in the connector 150, and the guide groove 117 is formed as an open, incomplete arc at the connector 150. Because the guide groove 117 is curved upward at the inclined section 117a of the first clamping member 11, it may cause more resistance when the puncture needle moves. Therefore, the open form of the connector 150 helps reduce resistance during the puncture needle's movement.

[0093] See also Figure 17 The delivery tube 16 is made of a polymer material and is slender and flexible. One end portion 165 thereof can be covered by hot-melt to cover the inwardly recessed portion of the connector 150. The delivery tube 16 has a plurality of mutually spaced cavities formed therein, which correspond to the guide groove 117, the transmission channel 115, and the two angiography channels 140 connected to the first clamping member 11. The transmission cavity 161 of the delivery tube 16 corresponding to the transmission channel 115 is used to accommodate the transmission shaft 132 extending from the first clamping member 11. The transmission shaft 132 can be a metal rod, which passes through the delivery tube 16 and is connected to the operating handle 18 (see Figure 18 ) corresponding drive device. The needle insertion channel 162 of the delivery catheter 16 corresponding to the guide groove 117 is used to accommodate the puncture needle, which is also connected to the operating handle. The imaging channel 163 of the delivery catheter 16 corresponding to the imaging channel 140 is used to introduce contrast agent or to withdraw blood during surgery.

[0094] See also Figure 18The proximal end of the delivery catheter 16 away from the leaflet capture assembly 10 is connected to an operating handle 18. The operating handle 18 has a button 181 connected to the transmission shaft 132. The housing 180 of the operating handle 18 can be provided with a slide groove for the button 181 to slide. By pressing and pushing the button 181, the transmission shaft 132 can be driven to move axially, thereby pushing the transmission connector 134 to move, so that the second clamping member 12 of the leaflet capture assembly 10 can be opened or closed relative to the first clamping member 11. The operating handle 18 also has a gas-liquid valve 182, which can serve as a contrast agent inlet, and can also serve as a blood withdrawal channel and an exhaust channel during surgery. The operating end of the suture implantation assembly 20 can be movably mounted on the end of the housing 180 of the operating handle 18.

[0095] Please also refer to Figures 19 to 21 The suture implantation assembly 20 includes a puncture needle assembly 21 and a suture pusher assembly 22. The puncture needle assembly 21 includes a puncture needle pusher handle 211, a guide assembly 212, and a puncture needle 213. The puncture needle pusher handle 211 is movably accommodated in the housing 180 of the operating handle 18. The puncture needle 213 is fixedly connected to the puncture needle pusher handle 211. The guide assembly 212 includes a guide sleeve 212a and a guide shaft 212b. The guide sleeve 212a is fixedly connected to the puncture needle pusher handle 211. The guide shaft 212b is fixed in the housing 180 of the operating handle 18, and one end of the guide sleeve 212a is accommodated in the guide sleeve 212a. The inner diameter of the guide sleeve 212b is slightly larger than the outer diameter of the puncture needle 213, but can support the puncture needle 213, thereby guiding the puncture needle 213. When the puncture needle pushing handle 211 is pushed, the guide sleeve 212a moves axially along the outer diameter of the guide shaft 212b, and the puncture needle 213 is pushed along the inner diameter of the guide shaft 212b through the delivery catheter 16 to reach the guide groove 117 of the leaflet capture assembly 10.

[0096] The suture pushing assembly 22 includes a pushing handle 221, a pushing shaft 222, and a pushing catheter 223. The pushing handle 221 can be simply annular. One end of the pushing shaft 222 is fixedly connected to the pushing handle 221, and the other end extends into the puncture needle pushing handle 211 and is fixedly connected to the pushing catheter 223. The pushing catheter 223 is movably received in the puncture needle 213. The suture 225 can be loaded into the pushing catheter 223 and does not need to be fixed in the pushing catheter 223. The end of the suture 225 extends out of the pushing catheter 223 and is received in the puncture needle 213. The suture 225 can be threaded on a gasket 225a, which is placed at the end of the pushing catheter 223. The end of the suture 225 can be knotted. The gasket 225a can be a metal tube. The suture 225 and the gasket 225a are pushed out of the puncture needle 213 by the pushing catheter 223.

[0097] See also Figures 22 to 25The valve repair device 500 provided in the second embodiment of the present invention differs from the valve repair device 100 of the first embodiment in that two convex components 125a are provided on the first clamping member 11a, one on each side of the transmission channel 115, and two grooves 119a are provided on the second clamping member 12a, one corresponding to each of the two convex components 125a. The two convex components 125a are cylindrical, and the two grooves 119a are circular holes, both through-holes. Each of the two grooves 119a of this second embodiment is smaller than the grooves 119 of the first embodiment, making it less likely for leaflets to accumulate in the grooves 119a. If a leaflet covers a groove 119a, the convex components 125a will not fit in the grooves 119a, making them visible on medical imaging. In this case, the position of the leaflet within the leaflet capture assembly can be adjusted by the transmission assembly 13.

[0098] Please also refer to Figures 26 to 29 The delivery catheter 16 of the valve repair device 100 can be loaded into a bending adjustment sheath, and the bending adjustment sheath can include a first bending adjustment sheath 200 and a second bending adjustment sheath 200. The first bending adjustment sheath 200 and the second bending adjustment sheath 200 play a role in guiding and bending in the heart tissue during the delivery of the valve repair device. The first bending adjustment sheath 200, the second bending adjustment sheath 200 and the valve repair device 100 can be operated independently outside the body. Under the observation of medical imaging, the leaflet capture component 10 is delivered to the top of the heart valve leaflet 400 to be repaired. Then, the second clamping member of the leaflet capture component 10 is opened relative to the first clamping member. At this time, the operating handle of the valve repair device 100 can be fine-tuned so that the second clamping member is at an angle basically perpendicular to the leaflet to align with the leaflet and retract the leaflet. At this time, the leaflet capture component 10 is closed to clamp the leaflet. Then, the suture implantation component 20 can be operated to puncture the leaflet with the puncture needle 213 (see Figure 31 ), and pushing the suture to the other side of the leaflet.

[0099] Please also refer to Figure 6 、 Figure 9 、 Figure 30 and Figure 31When the leaflet capture assembly 10 of the valve repair device 100 of the embodiment of the present invention enters the heart valve to be repaired, such as the mitral valve, the second clamping member 12 opens relative to the first clamping member 11 to align with the leaflet of the mitral valve. At this time, the leaflet to be repaired, such as the anterior leaflet or the posterior leaflet, can fall between the first clamping member 11 and the second clamping member 12. Due to the curved design of the transmission connecting member 134 of the transmission assembly 13, during the closing process of the second clamping member 12 relative to the first clamping member 11, the curved portion 134a will push the leaflet from the arc surface 134d to the first flat surface 134e, so that the leaflet is basically clamped between the clamping area 114 of the first clamping member 11 and the clamping area 124 of the second clamping member 12, preventing too many leaflets from accumulating between the connecting portion 112 of the first clamping member 11 and the connecting portion 122 of the second clamping member 12. When the convex part 125 on the second clamping member 12 cannot close with the groove 119 on the first clamping member 11, it also serves as a prompt, prompting the leaflet capture component 10 to fine-tune the angle, and the second clamping member 12 can reopen the accommodating leaflet and reopen it relative to the first clamping member 11.

[0100] As mentioned above, the first clamping member 11 and the non-clamping area 116, 126 of the leaflet capture assembly 10 of the valve repair device 100 of the embodiment of the present invention just form a puncture area, and the tilt design of the non-clamping area 116, 126, the angle design of the guide groove 117 and the design of the limit groove 127 (see Figure 6-8 ) The puncture needle is basically perpendicular to the valve leaflet during puncture, making the puncture easier and more accurate.

[0101] After the suture implantation assembly 20 of the valve repair device 100 of the embodiment of the present invention pushes the suture 225 to the other side of the valve leaflet, another device can be used to secure the suture 225 to the heart tissue, thereby performing a suturing function. Alternatively, the suture 225 can be used as an artificial chordae tendineae to directly replace the natural chordae tendineae of the heart. The gasket 225a of the suture 225 can help secure the suture 225 to the papillary muscle. The suture can be made of PTFE, e-PTFE, PET, UHMWPE, etc.

[0102] After the suture implantation of the valve repair device 100 according to the embodiment of the present invention is completed, the suture is left in the heart tissue, the puncture needle is withdrawn, and then the leaflet capture assembly 10 is withdrawn, so that the valve repair device 100 is separated from the heart tissue and withdrawn.

[0103] It is understood that the above diagrams only illustrate the puncture direction of the valve leaflets from the atrial side to the ventricular side during suture implantation. The valve repair device of the present application can also be used to puncture the valve leaflets from the ventricular side to the atrial side, for example, using a delivery path through the right ventricle-ventricular septum-left ventricle-mitral valve, or a delivery path through the apex-left ventricle-mitral valve. Of course, the valve repair device of the present application can also be used for suture implantation of the tricuspid valve. Except for the difference in the path of the interventional surgery, the structure of the tricuspid valve repair device is the same as that of the mitral valve repair device, and will not be described in detail here.

[0104] The above is only a preferred embodiment of the present application and does not constitute any formal limitation to the present application. Although the present application has been disclosed as above in terms of a preferred embodiment, it is not intended to limit the present application. Any technician familiar with the art can, without departing from the scope of the technical solution of the present application, use the methods and technical contents disclosed above to make many possible changes and modifications to the technical solution of the present application, or modify it into an equivalent embodiment of an equivalent change. Therefore, any simple modification, equivalent change and modification made to the above embodiment based on the technical essence of the present application without departing from the content of the technical solution of the present application still falls within the scope of protection of the technical solution of the present application.

Claims

1. A valve repair device, characterized in that: It includes: a leaflet capture assembly, comprising a first clamping member, a second clamping member, and a transmission assembly, wherein the second clamping member can be opened relative to the first clamping member to form an angle, or closed to capture the leaflets of the valve between the first clamping member and the second clamping member, through transmission by the transmission assembly; and a suture puncture assembly, the suture puncture assembly comprising a puncture needle and a suture accommodated in the puncture needle and capable of being pushed; the first clamping member being provided with a guide groove; after the leaflet capturing assembly captures the leaflet, the puncture needle passes through the guide groove and punctures the leaflet, and the suture is pushed out of the puncture needle to the other side of the leaflet; The facing surfaces of the first clamping member and the second clamping member are both provided with a clamping area and a non-clamping area, at least one of the clamping areas is provided with clamping teeth to clamp the leaflet between the two clamping areas, the non-clamping areas of the first clamping member and the second clamping member are respectively inclined relative to the clamping areas, and the non-clamping areas of the first clamping member and the second clamping member are parallel to each other, the non-clamping areas of the first clamping member and the second clamping member have an inclination angle A relative to the corresponding clamping areas, the guide groove includes an inclination section adjacent to the non-clamping area of ​​the first clamping member, the inclination section has an inclination angle B relative to the inclination starting point of the guide groove in the first clamping member, and the angle C of the puncture needle puncturing the leaflet satisfies C=A+B.

2. The valve repair device according to claim 1, wherein: The guide groove is communicated with the non-clamping area of ​​the first clamping member. When the first clamping member and the second clamping member are relatively closed, a gap is provided between the non-clamping areas of the first clamping member and the second clamping member to accommodate a portion of the leaflet that is not clamped.

3. The valve repair device according to claim 2, characterized in that: The first clamping member and the second clamping member are respectively provided with a connecting portion, the connecting portion is located on the side of the clamping area away from the non-clamping area, the connecting portion of the second clamping member is hinged to the connecting portion of the first clamping member, and one end of the transmission assembly is connected to the connecting portion of the second clamping member to drive the second clamping member to open and close relative to the first clamping member.

4. The valve repair device according to claim 3, characterized in that: A transmission channel is provided in the first clamping member, the transmission channel is communicated with the clamping area of ​​the first clamping member and extends to the connecting portion, the transmission assembly includes a transmission shaft and a transmission connecting member, the transmission shaft is movably accommodated in the transmission channel, one end of the transmission connecting member is pivotally connected to the second clamping member through a first pivot shaft, and the other end of the transmission connecting member is movably accommodated in the transmission channel and is pivotally connected to one end of the transmission shaft through a second pivot shaft.

5. The valve repair device according to claim 4, characterized in that: The connecting portion of the second clamping member has two ribs arranged at relative intervals, and one end of the two ribs away from the clamping area is hinged to the two sides of the connecting portion of the first clamping member through a rotating shaft, and one end of the two ribs close to the clamping area is pivotally connected to the transmission connecting member through the first pivot shaft.

6. The valve repair device according to claim 4, characterized in that: The clamping areas of the first clamping member and the second clamping member are provided with a plurality of clamping teeth adapted to each other for clamping the leaflets. The transmission channel has an opening in the clamping area of ​​the first clamping member, and the opening partially interrupts the clamping teeth of the first clamping member.

7. The valve repair device according to claim 4, characterized in that: A limiting boss is provided at the connection between the transmission channel and the connection portion, and the limiting boss is used to limit the transmission connection member to limit the maximum angle at which the second clamping member opens relative to the first clamping member.

8. The valve repair device according to claim 7, characterized in that: The transmission channel includes a curved section, the limiting boss is located at the end position of the curved section at the connecting portion, the transmission connecting member includes a curved portion and a straight portion connected to the curved portion, the bottom surface of the curved portion close to the curved section has a rounded corner, the surface of the curved portion facing away from the curved section has an arc surface, the surface of the straight portion connected to the arc surface is a straight surface, at least a portion of the arc surface is located at the second clamping member, and at least a portion of the straight portion is located at the first clamping member.

9. The valve repair device according to claim 2, characterized in that: The non-clamping area of ​​the second clamping member is provided with a limiting groove which penetrates the second clamping member and is open at one end toward the end direction. The limiting groove is aligned with and lower than the guide groove. The puncture needle punctures the leaflet in the limiting groove.

10. The valve repair device according to claim 9, characterized in that: The length of the non-clamping area of ​​the first clamping member and the second clamping member from the distal end to the proximal end is between 2-5 mm, the gap between the non-clamping area of ​​the first clamping member and the second clamping member is between 0.5-2 mm, and the length of the clamping area of ​​the first clamping member and the second clamping member from the distal end to the proximal end is between 3-5 mm.

11. The valve repair device according to claim 1, wherein: The inclination angle A of the non-clamping area is between 45-70 degrees, the inclination angle B of the guide groove is between 0-20 degrees, and the angle C of the puncture needle puncturing the leaflet is between 45-90 degrees.

12. The valve repair device according to claim 4, wherein: An open groove is formed on a surface of the first clamping member facing away from the second clamping member, and the open groove is used to observe the connection status of the transmission shaft and the transmission connecting member.

13. The valve repair device according to claim 1, wherein: The first clamping member is further provided with a radiographic channel, which is communicated with the non-clamping area and is used for introducing a radiographic agent. The radiographic channel is located below the guide groove.

14. The valve repair device according to claim 13, wherein: The end of the first clamping member away from the second clamping member has a cylindrical end and a connecting head, the non-clamping area of ​​the first clamping member is formed on the side of the cylindrical end facing the second clamping member, and the connecting head is formed on the other side of the cylindrical end, the guide groove, the transmission channel and the radiography channel extend from the connecting head through the cylindrical end to the side of the non-clamping area, the guide groove is in an open state at the connecting head, and the connecting head is used to connect the delivery catheter.

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