Valve clamping system

Abstract

The present application belongs to the field of medical devices, and particularly relates to a valve clamping system, which comprises a valve clamping device and a delivery device. The valve clamping device comprises a fixed seat, a first proximal clamping piece and a second proximal clamping piece arranged on the fixed seat and capable of being folded or unfolded relative to the fixed seat. The delivery device is detachably connected to the valve clamping device, and comprises a delivery sheath, a wire guide, a first control wire and a second control wire. By symmetrically arranging two wire guides on the distal end of the delivery sheath relative to the central axis of the delivery sheath, when the corresponding proximal clamping piece is controlled to be folded relative to the fixed seat by the first control wire or the second control wire, the resultant force of the pulling force acting on the corresponding proximal clamping piece acts on the central axis of the delivery sheath through the two wire guides, so that the bending of the delivery sheath does not cause the valve clamping device to swing and shift, which facilitates the surgical operation and is beneficial to shorten the operation time and improve the operation efficiency.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a valve clamping system. BACKGROUND

[0002] Mitral regurgitation is one of the most common valvular lesions today, and the main causes are mitral annulus dilatation, chordal insufficiency, mitral valve myxomatous degeneration, leaflet prolapse, rheumatic valvular disease, ischemic lesions, etc. Mitral valve plasty and artificial valve replacement are the most effective methods for treating mitral regurgitation, but due to the need for extracorporeal circulation technology support, the trauma to the human body is relatively large, and there is a considerable high complication and mortality rate for elderly patients and patients with many complications.

[0003] In recent years, medical personnel and scientific researchers in various countries have explored transcatheter mitral valve repair techniques, and the main interventional treatment methods include annuloplasty, negative pressure suction suture technology, and mitral valve clipping, etc., among which the mitral valve clipping has the most reliable curative effect. The mitral valve clipping sends an implantable valve clamping device to the vicinity of the mitral valve through transseptal puncture, clamps and fixes the free edges of the anterior and posterior leaflets, so that the leaflets are well coapted at the end of systole, and the regurgitation is reduced. However, in the related technology, when the clamping action of each side of the clamping device is controlled separately, the tension of the control line on the clamping piece will generate a certain moment on the clamping device, which will further cause the clamping device to deflect towards the side where the tension is located, and further cause the delivery sheath to bend and the clamping device to shift, resulting in the need to reposition and adjust, which prolongs the operation time and reduces the operation efficiency. SUMMARY

[0004] The present application provides a valve clamping system to solve the problem that when the clamping action of each side of the clamping device is controlled separately, the tension of the control line causes the delivery sheath to bend and the clamping device to shift.

[0005] To achieve the above-mentioned purpose, the present application provides a valve clamping system, comprising:

[0006] a valve clamping device, comprising a fixed seat and a first proximal clamping piece and a second proximal clamping piece arranged on the fixed seat and capable of being folded or unfolded relative to the fixed seat; and

[0007] a delivery device, detachably connected to the valve clamping device, the delivery device comprising a delivery sheath, a wire guide, a first control line and a second control line, the two wire guides being arranged at the distal end of the delivery sheath, and the two wire guides being symmetrical about the central axis of the delivery sheath; the first control line is connected to the first proximal clamping piece, and the first control line extends to the proximal end of the delivery sheath after passing through the two wire guides; the second control line is connected to the second proximal clamping piece, and the second control line extends to the proximal end of the delivery sheath after passing through the two wire guides.

[0008] Optionally, the distal end of the delivery sheath is symmetrically provided with two insertion holes about the central axis of the delivery sheath, and the two wire guides are respectively in sliding connection with the two insertion holes.

[0009] Optionally, the wire guide comprises a guide member and a threading ring, the guide member is slidingly inserted into the insertion hole, and the guide member extends out of the insertion hole towards one end of the valve clamping device and is connected with the threading ring.

[0010] Optionally, both of the insertion holes extend from the distal end of the delivery sheath to the proximal end of the delivery sheath, the guide member is a hollow catheter, and the first control wire and the second control wire around the two wire guides can extend to the proximal end of the delivery sheath through the inside of the catheter and the insertion hole.

[0011] Optionally, the delivery sheath is provided with a hole cavity extending in the axial direction, and the first control wire and the second control wire around the two wire guides both extend to the proximal end of the delivery sheath through the hole cavity.

[0012] Optionally, the end of the first proximal clamping piece away from the fixed seat and the end of the second proximal clamping piece away from the fixed seat are both provided with a connecting hole, after the first control wire passes through the connecting hole on the first proximal clamping piece, the two active ends of the first control wire are correspondingly around the two wire guides and then extend to the proximal end of the delivery sheath through the hole cavity, and after the second control wire passes through the connecting hole on the second proximal clamping piece, the two active ends of the second control wire are correspondingly around the two wire guides and then extend to the proximal end of the delivery sheath through the hole cavity.

[0013] Optionally, the number of hole cavities is four, and the two active ends of the first control wire and the two active ends of the second control wire are respectively correspondingly threaded through the four hole cavities.

[0014] Optionally, the first proximal clamping piece and the second proximal clamping piece are symmetrically arranged about the fixed seat, and the end of the first proximal clamping piece close to the fixed seat is connected with the end of the second proximal clamping piece close to the fixed seat through a connecting frame.

[0015] Optionally, the first proximal clamping piece and the second proximal clamping piece are at least partially made of shape memory material.

[0016] Optionally, the valve clamping system further comprises a handle and a first operating rod and a second operating rod arranged on the handle, the handle is connected with the proximal end of the delivery sheath, the first operating rod is connected with the first control wire to control the first proximal clamping piece to be folded or unfolded relative to the fixed seat through the first control wire, and the second operating rod is connected with the second control wire to control the second proximal clamping piece to be folded or unfolded relative to the fixed seat through the second control wire.

[0017] The valve clamping system provided by the application has the beneficial effect that, compared with the prior art, the valve clamping system of the application is provided with two wire guides which are symmetrically arranged about the central axis of the delivery sheath tube at the distal end of the delivery sheath tube, the first control wire for controlling the first proximal clamping piece is connected to the first proximal clamping piece, the first control wire extends to the proximal end of the delivery sheath tube after passing through the two wire guides, the second control wire for controlling the second proximal clamping piece is connected to the second proximal clamping piece, the second control wire extends to the proximal end of the delivery sheath tube after passing through the two wire guides, when the corresponding proximal clamping piece is controlled to be folded relative to the fixed seat by the first control wire or the second control wire, the resultant force of the pulling force acting on the corresponding proximal clamping piece acts on the central axis of the delivery sheath tube through the two wire guides, so that the bending of the delivery sheath tube does not cause the valve clamping device to swing and shift, the operation is facilitated, and the operation time is shortened and the operation efficiency is improved. BRIEF DESCRIPTION OF DRAWINGS

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0019] Among them:

[0020] Figure 1 is a structural schematic diagram of the valve clamping system shown in an embodiment of the present application;

[0021] Figure 2 is a connection schematic diagram of the valve clamping device and the delivery device of the valve clamping system shown in an embodiment of the present application;

[0022] Figure 3 is a schematic diagram of the first proximal clamping piece and the second proximal clamping piece in the valve clamping device of the valve clamping system shown in an embodiment of the present application when being folded relative to the fixed seat;

[0023] Figure 4 is a schematic diagram of the first proximal clamping piece and the second proximal clamping piece in the valve clamping device of the valve clamping system shown in an embodiment of the present application when being unfolded relative to the fixed seat;

[0024] Figure 5 is a schematic diagram of the wire guide in the delivery device of the valve clamping system shown in an embodiment of the present application when extending out of the insertion hole;

[0025] Figure 6 is a schematic diagram of a structure of the wire guide in the valve clamping device of the valve clamping system shown in an embodiment of the present application;

[0026] Figure 7is another structure sectional view of the wire guide in the valve clamping device of the valve clamping system according to an embodiment of the present application;

[0027] Figure 8 is a schematic view of the first control wire and the second control wire passing through the insertion hole in the valve clamping system according to an embodiment of the present application;

[0028] Figure 9 is a schematic view of a passing mode of the first control wire and the second control wire and the cavity in the delivery sheath in the valve clamping system according to an embodiment of the present application;

[0029] Figure 10 is a schematic view of another passing mode of the first control wire and the second control wire and the cavity in the delivery sheath in the valve clamping system according to an embodiment of the present application;

[0030] Figure 11 is a schematic view of another passing mode of the first control wire and the second control wire and the cavity in the delivery sheath in the valve clamping system according to an embodiment of the present application;

[0031] Figure 12 is a schematic view of the connection of the first proximal clamping piece and the second proximal clamping piece in the valve clamping device of the valve clamping system according to an embodiment of the present application.

[0032] Main element symbol explanation:

[0033] 100, valve clamping device;

[0034] 110, fixed seat; 120, first proximal clamping piece; 130, second proximal clamping piece; 140, distal clamping piece; 150, connecting rod; 160, control rod; 101, connecting hole; 102, connecting frame;

[0035] 200, delivery device;

[0036] 210, delivery sheath; 211, fixed head; 220, wire guide; 221, guide; 222, wire passing ring; 230, first control wire; 240, second control wire; 250, connecting piece; 201, insertion hole; 202, hole cavity;

[0037] 300, handle;

[0038] 400, first operating rod;

[0039] 500, second operating rod. DETAILED DESCRIPTION

[0040] For the purpose of promoting an understanding of the application, the application will now be described in greater detail with reference to the figures. The preferred embodiments of the application are illustrated in the figures. However, the application can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and fully convey the scope of the application to those skilled in the art.

[0041] It should be noted that when an element is referred to as being "fixed" or "set" on another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or indirectly connected to the other element.

[0042] In addition, the terms "first", "second", and the like are used only to describe the purpose of distinguishing between different features, and should not be construed as indicating or implying relative importance or a quantity of the indicated technical features. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "a plurality of" is two or more, unless otherwise specifically limited.

[0043] It should be noted that in the field of interventional medical devices, the proximal end refers to the end of the medical device closer to the operator, and the distal end refers to the end of the medical device farther from the operator; the axial direction refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device in a natural state.

[0044] As described in the background, in the related art, when the clamping action of each side of the clip is controlled separately in the mitral valve clipping, the tension exerted by the control line on the clamping piece will generate a certain torque on the clip, which will further cause the clip to deflect towards the side where the tension is located, and further cause the delivery sheath 210 to bend and the clip to shift, resulting in the need to re-adjust the positioning, prolonging the operation time and reducing the operation efficiency.

[0045] To solve the above problems, the embodiments of the present application provide a valve clamping system, which aims to avoid the tension exerted by the control line causing the delivery sheath to bend and the clip to shift when the clamping action of each side of the clip is controlled separately, thereby facilitating the operation, shortening the operation time and improving the operation efficiency.

[0046] In the embodiments of the present application, as Figures 1-4As shown, the valve clamping system comprises a valve clamping device 100 and a delivery device 200, the valve clamping device 100 comprises a fixed seat 110 and a first proximal clamping piece 120 and a second proximal clamping piece 130 arranged on the fixed seat 110 and capable of being folded or unfolded relative to the fixed seat 110, the delivery device 200 is detachably connected to the valve clamping device 100, the delivery device 200 comprises a delivery sheath 210, two wire guides 220, a first control wire 230 and a second control wire 240, the two wire guides 220 are arranged at the distal end of the delivery sheath 210, and the two wire guides 220 are symmetrical about the central axis of the delivery sheath 210; the first control wire 230 is connected to the first proximal clamping piece 120, and the first control wire 230 extends to the proximal end of the delivery sheath 210 after bypassing the two wire guides 220; the second control wire 240 is connected to the second proximal clamping piece 130, and the second control wire 240 extends to the proximal end of the delivery sheath 210 after bypassing the two wire guides 220.

[0047] The valve clamping device 100 further comprises two distal clamping pieces 140 rotatably connected to the fixed seat 110 and a driving assembly for driving the distal clamping pieces 140 to open and close relative to the fixed seat 110, the two proximal clamping pieces (i.e. the first proximal clamping piece 120 and the second proximal clamping piece 130) and the two distal clamping pieces 140 correspond to each other to form two clamping jaws, the two clamping jaws can clamp the anterior leaflet and the posterior leaflet of the mitral valve respectively to reduce the inter-valve gap, and remain in the patient's body as an implant to alleviate or treat the patient's "mitral regurgitation". The driving assembly comprises a control rod 160 arranged in the fixed seat 110 to slide axially and a connecting rod 150 connecting the distal clamping pieces 140 and the control rod 160. When the push rod slides axially relative to the fixed seat 110, the distal clamping pieces 140 are opened relative to the fixed seat 110 under the pulling of the connecting rod 150. After the distal clamping pieces 140 are placed in the appropriate position under the valve, the control of the first control wire 230 and the second control wire 240 on the first proximal clamping piece 120 and the second proximal clamping piece 130 is released, the first proximal clamping piece 120 and the second proximal clamping piece 130 are released to unfold relative to the fixed seat 110, and the first proximal clamping piece 120 and the second proximal clamping piece 130 approach the respective distal clamping pieces 140 to clamp the valve between the proximal clamping pieces and the distal clamping pieces 140.

[0048] The first control wire 230 and the second control wire 240 are each a single wire or a plurality of wires wound together, and the wire can be selected from a nickel-titanium wire, a stainless steel wire or a high-strength polymer wire.

[0049] In the embodiment of the present application, the valve clamping system is provided with two wire guides 220 symmetrically arranged about the central axis of the delivery sheath 210, when the first proximal clamping piece 120 is controlled to be folded relative to the fixed seat 110 by the first control wire 230 or the second proximal clamping piece 130 is controlled to be folded relative to the fixed seat 110 by the second control wire 240, the resultant force of the pulling force acting on the first proximal clamping piece 120 or the second proximal clamping piece 130 is applied to the central axis of the delivery sheath 210 through the two wire guides 220, so that the moment generated by the resultant force on the valve clamping device 100 is zero, thereby avoiding the bending of the delivery sheath 210 causing the valve clamping device 100 to swing and shift, facilitating the surgical operation, and being beneficial to shorten the operation time and improve the operation efficiency.

[0050] In addition, as shown in Figure 3 when the first proximal clamping piece 120 and the second proximal clamping piece 130 are completely pulled up and folded relative to the fixed seat 110, due to the guiding effect of the wire guide 220, the first control wire 230 and the second control wire 240 are still at a certain angle with the first proximal clamping piece 120 and the second proximal clamping piece 130 respectively, so that the force of the first control wire 230 and the second control wire 240 acting on the first proximal clamping piece 120 and the second proximal clamping piece 130 respectively increases the component force of the first proximal clamping piece 120 and the second proximal clamping piece 130 to the fixed seat 110, so that the first proximal clamping piece 120 and the second proximal clamping piece 130 are more easily pulled up, and the stress of the first control wire 230 and the second control wire 240 is smaller.

[0051] It can be understood that since the first control wire 230 and the second control wire 240 are respectively connected to the first proximal clamping piece 120 and the second proximal clamping piece 130, pulling the first control wire 230 alone is suitable for controlling the folding or unfolding of the first proximal clamping piece 120, pulling the second control wire 240 alone is suitable for controlling the folding or unfolding of the second proximal clamping piece 130, and of course, pulling the first control wire 230 and the second control wire 240 simultaneously is suitable for controlling the simultaneous folding or unfolding of the first proximal clamping piece 120 and the second proximal clamping piece 130.

[0052] In order to ensure the safety of the valve clamping device 100 after implantation, the fixed seat 110, the first proximal clamping piece 120, the second proximal clamping piece 130 and the distal clamping piece 140 can be made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy; the control rod 160 and the connecting rod 150 can be made of biocompatible high polymer materials or metal materials such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy.

[0053] In one embodiment, as Figures 2-5As shown, the distal end of the delivery sheath 210 is symmetrically provided with two insertion holes 201 about the central axis of the delivery sheath 210, and the two wire guides 220 are respectively slidably connected with the two insertion holes 201.

[0054] By slidably connecting the wire guides 220 with the insertion holes 201 on the delivery sheath 210, when the first proximal clamping piece 120 and the second proximal clamping piece 130 are respectively controlled by the first control wire 230 and the second control wire 240, the wire guides 220 can be flexibly adjusted, automatically adjusting the force angle of the first control wire 230 and the second control wire 240, ensuring that the force of the first control wire 230 and the second control wire 240 is in a minimum state, thereby reducing the operating force applied to the first control wire 230 and the second control wire 240, making the control of the first proximal clamping piece 120 and the second proximal clamping piece 130 more flexible.

[0055] In a specific embodiment, as shown, Figures 2-7 The wire guide 220 includes a guide piece 221 and a threading ring 222, the guide piece 221 is slidably inserted into the insertion hole 201, and one end of the guide piece 221 extends out of the insertion hole 201 and is connected with the threading ring 222.

[0056] By providing the threading ring 222, after the first control wire 230 and the second control wire 240 are threaded through the threading hole in the middle of the threading ring 222, the first control wire 230 and the second control wire 240 will not slip off during the operation process, ensuring the stability of the control.

[0057] It should be noted that the insertion hole 201 and the guide piece 221 have a certain length, so that during the operation process, the guide piece 221 has enough extension stroke and will not completely come out of the insertion hole 201.

[0058] Specifically, as shown, Figures 6-7 The threading ring 222 can be made of a coil or directly have a ring structure, since the threading ring 222 is a closed loop structure, the first control wire 230 and the second control wire 240 will not slip off the wire guide 220, and the control is more stable, orderly and neat.

[0059] During production, the guide piece 221 and the threading ring 222 can be integrally formed by metal or high polymer material, or they can be separately processed and then connected by welding.

[0060] Further, to make the tightening and loosening of the first control wire 230 and the second control wire 240 more smooth, and to reduce the risk of wear of the first control wire 230 and the second control wire 240, the surface of the threading ring 222 is smooth, so as to reduce the friction between the first control wire 230 and the second control wire 240 and the threading ring 222.

[0061] In a more specific embodiment, as shown in Figures 7-8 The two insertion holes 201 extend from the distal end of the delivery sheath 210 to the proximal end of the delivery sheath 210, and the guide 221 is a hollow catheter. The first control wire 230 and the second control wire 240 bypassing the two wire guides 220 can extend to the proximal end of the delivery sheath 210 through the interior of the catheter and the insertion hole 201.

[0062] By extending the insertion hole 201 provided with the guide 221 to the proximal end of the delivery sheath 210, and setting the guide 221 as a hollow catheter, the interior of the catheter and the insertion hole 201 are used as a channel for the first control wire 230 and the second control wire 240 to extend to the distal end of the delivery sheath 210, which simplifies the structure of the device and reduces the production cost.

[0063] In an embodiment, as shown in Figures 1-5 and Figures 9-11 The delivery sheath 210 is provided with an axial hole 202, and the first control wire 230 and the second control wire 240 bypassing the two wire guides 220 extend to the proximal end of the delivery sheath 210 through the hole 202.

[0064] By providing the hole 202, a channel is provided for the first control wire 230 and the second control wire 240 to hide in the interior of the delivery sheath 210, which not only protects the first control wire 230 and the second control wire 240, but also makes the entire valve clamping system more simple and beautiful.

[0065] Specifically, the delivery sheath 210 can be a multi-lumen tube made of biocompatible metal materials or polymer materials by one-piece molding, or a multi-lumen tube formed by pressing, welding or bonding of several single tubes made of biocompatible metal materials or polymer materials. The metal material is selected from stainless steel, aluminum alloy or cobalt-chromium alloy; the polymer material is selected from polycarbonate, polyethylene or polyamide. In this embodiment, the delivery sheath 210 is a multi-lumen tube made by one-piece molding.

[0066] It should be noted that the number of holes 202 is at least one, as shown in Figure 11 The number of holes 202 can be designed to be one or two or four, which is not limited here.

[0067] The cross-sectional shape of the hole 202 can be circular, square, polygonal or other special-shaped. In this embodiment, the cross-section of the hole 202 is designed to be circular.

[0068] In a specific embodiment, as shown in Figures 2-5 and Figures 9-11As shown, the one end of the first proximal clamping piece 120 and the one end of the second proximal clamping piece 130 away from the fixed base 110 are provided with connecting holes 101, after the first control line 230 passes through the connecting hole 101 on the first proximal clamping piece 120, the two movable ends of the first control line 230 pass through the two wire guides 220 one by one, and then extend to the proximal end of the delivery sheath 210 through the hole cavity 202, after the second control line 240 passes through the connecting hole 101 on the second proximal clamping piece 130, the two movable ends of the second control line 240 pass through the two wire guides 220 one by one, and then extend to the proximal end of the delivery sheath 210 through the hole cavity 202.

[0069] By providing the connecting holes 101 on the one end of the first proximal clamping piece 120 and the one end of the second proximal clamping piece 130 away from the fixed base 110, it is convenient to apply tension to the proximal clamping piece by the control line to make it fold relative to the fixed base 110.

[0070] In a more specific embodiment, as shown in Figures 2-5 and Figures 9-11 As shown, the distal end of the delivery sheath 210 is symmetrically provided with two insertion holes 201 about the central axis of the delivery sheath 210, the wire guide 220 includes a guide piece 221 and a threading ring 222, the guide piece 221 is slidingly inserted into the insertion hole 201, and the one end of the guide piece 221 extends out of the insertion hole 201 and is connected with the threading ring 222, the one end of the first proximal clamping piece 120 and the one end of the second proximal clamping piece 130 away from the fixed base 110 are provided with connecting holes 101, after the first control line 230 passes through the connecting hole 101 on the first proximal clamping piece 120, the two movable ends of the first control line 230 pass through the threading ring 222 on the two wire guides 220 one by one, and then extend to the proximal end of the delivery sheath 210 through the hole cavity 202, after the second control line 240 passes through the connecting hole 101 on the second proximal clamping piece 130, the two movable ends of the second control line 240 pass through the threading ring 222 on the two wire guides 220 one by one, and then extend to the proximal end of the delivery sheath 210 through the hole cavity 202.

[0071] In this embodiment, when the first proximal clamping piece 120 and the second proximal clamping piece 130 are controlled by the first control line 230 and the second control line 240 respectively, the wire guide 220 can be flexibly adjusted, the force angle of the first control line 230 and the second control line 240 is automatically adjusted, the force of the first control line 230 and the second control line 240 is ensured to be in the minimum state, so as to reduce the operating force of the first control line 230 and the second control line 240, so that the control of the first proximal clamping piece 120 and the second proximal clamping piece 130 is more flexible, and after the first control line 230 and the second control line 240 pass through the threading ring 222, the first control line 230 and the second control line 240 will not slip during the operation process, so as to ensure the stability of the control.

[0072] In some embodiments, as shown in Figure 2 and Figure 9 the number of the hole cavities 202 is four, and two active ends of the first control line 230 and two active ends of the second control line 240 are respectively and correspondingly arranged in the four hole cavities 202.

[0073] The four hole cavities 202 are arranged, and four active ends of two control lines (i.e. the first control line 230 and the second control line 240) are respectively and correspondingly arranged in the four hole cavities 202, so that each active end has an independent hole cavity 202, and the first control line 230 and the second control line 240 are prevented from being entangled.

[0074] In an embodiment, as shown in Figures 2-5 and Figure 12 the first proximal clamping piece 120 and the second proximal clamping piece 130 are arranged in axial symmetry about the fixed seat 110, and an end of the first proximal clamping piece 120 close to the fixed seat 110 is connected with an end of the second proximal clamping piece 130 close to the fixed seat 110 through the connecting frame 102.

[0075] Thus, the two proximal clamping pieces (i.e. the first proximal clamping piece 120 and the second proximal clamping piece 130) and the two distal clamping pieces 140 are arranged in axial symmetry about the fixed seat 110, and the two clamps are arranged in axial symmetry about the fixed seat 110, which facilitates clamping the anterior leaflet and the posterior leaflet of the mitral valve to reduce the inter-leaflet gap.

[0076] Specifically, the proximal clamping piece is made of super-elastic nickel-titanium alloy as a whole, and the connecting frame 102 is also made of nickel-titanium alloy and is integrally formed with the proximal clamping piece, so as to reduce the production process difficulty, simplify the process flow, and reduce the production cost. In other embodiments, the connecting frame 102 can also be made of stainless steel and welded with the proximal clamping piece, so as to improve the connection strength between the connecting frame 102 and the first proximal clamping piece 120 and the second proximal clamping piece 130.

[0077] In a specific embodiment, the first proximal clamping piece 120 and the second proximal clamping piece 130 are at least partially made of shape memory material.

[0078] It can be understood that the natural state of the first proximal clamping piece 120 and the second proximal clamping piece 130 is unfolded relative to the fixed seat 110, and the free end of the corresponding proximal clamping piece is controlled by the control line to be folded relative to the fixed seat 110, so that the free end of the proximal clamping piece is attached to the surface of the fixed seat 110 for convenient transportation. After the control of the free end of the corresponding proximal clamping piece by the control line is released, the free end of the proximal clamping piece is released, the proximal clamping piece rebounds and recovers the natural state due to the elastic memory performance of the proximal clamping piece, and the free end of the proximal clamping piece is unfolded relative to the fixed seat 110 to press the leaflet towards the distal clamping piece 140, thereby achieving clamping of the leaflet.

[0079] In some embodiments, as shown in Figures 1-5 The valve clamping system further comprises a handle 300, and a first operating rod 400 and a second operating rod 500 arranged on the handle 300, the handle 300 is connected with the proximal end of the delivery sheath 210, the first operating rod 400 is connected with the first control wire 230 to control the first proximal clamping piece 120 to be folded or unfolded relative to the fixed seat 110 through the first control wire 230, and the second operating rod 500 is connected with the second control wire 240 to control the second proximal clamping piece 130 to be folded or unfolded relative to the fixed seat 110 through the second control wire 240.

[0080] The delivery device 200 further comprises a connecting piece 250 inserted into the distal end of the delivery sheath 210, a liner (not shown in the figure) movably coaxially sleeved in the lumen of the connecting piece 250, and a mandrel (not shown in the figure) movably coaxially sleeved in the liner. The operator can pull the first control wire 230 and the second control wire 240 through the first operating rod 400 and the second operating rod 500 arranged on the handle 300, and drive the liner and the mandrel to move or rotate relative to each other through the handle 300.

[0081] The delivery sheath 210 is provided with a lumen in the axial direction, the connecting piece 250 is inserted into the distal end of the lumen, and the liner and the mandrel extend through the lumen to the handle 300. Preferably, in the embodiment, the distal end of the delivery sheath 210 is provided with a fixed head 211, and the connecting piece 250, the liner and the mandrel coaxially sleeved together are inserted into the lumen of the delivery sheath 210 through the fixed head 211 to improve the connection strength. It can be understood that the fixed head 211 is provided with a bypass channel corresponding to the positions of the insertion hole 201, the hole cavity 202 and the lumen.

[0082] The connecting piece 250 is generally tubular, and two connecting rods (not shown in the figure) are symmetrically arranged on the distal end of the connecting piece 250, and the distal end of each connecting rod is provided with a buckle for detachable connection with the fixed seat 110. When the connecting rod is subjected to a radial outward pushing force along the connecting piece 250, the distal end of the connecting rod expands outward. The liner of the delivery device 200 is movably arranged in the lumen of the connecting piece 250, and the liner is driven to move towards the distal end, the liner pushes the connecting rod outward in the radial direction, the buckle of the connecting rod expands outward and is clamped into the clamping hole of the fixed seat 110, so that the delivery device 200 is in a connected state with the fixed seat 110 through the connecting piece 250. It can be understood that the liner is withdrawn towards the proximal end, the distal end of the connecting rod is collected towards the axial line of the connecting piece 250 due to the elastic rebound of the connecting rod, the buckle exits the corresponding clamping hole, and the connection state of the delivery device 200 and the fixed seat 110 is released.

[0083] The core shaft is detachably connected with the control rod 160 for driving the control rod 160 to slide along the axial direction of the fixed seat 110, so as to drive the distal clamping piece 140 to open and close relative to the fixed seat 110. In the embodiment, the core shaft is a circular rod body with an internally threaded hole (not shown in the figure) formed at the distal end, which is used for threaded connection with the external thread at the proximal end of the control rod 160.

[0084] In summary, the valve clamping system provided by the embodiment has at least the following beneficial technical effects:

[0085] The valve clamping system is provided with two wire guides symmetrically arranged about the central axis of the delivery sheath tube at the distal end of the delivery sheath tube, the first control wire for controlling the first proximal clamping piece is connected to the first proximal clamping piece, the first control wire extends to the proximal end of the delivery sheath tube after passing through the two wire guides, the second control wire for controlling the second proximal clamping piece is connected to the second proximal clamping piece, the second control wire extends to the proximal end of the delivery sheath tube after passing through the two wire guides, when the corresponding proximal clamping piece is controlled to be folded relative to the fixed seat by the first control wire or the second control wire, the resultant force of the pulling force acting on the corresponding proximal clamping piece acts on the central axis of the delivery sheath tube through the two wire guides, so that the moment generated by the resultant force on the valve clamping device is zero, thereby avoiding the bending of the delivery sheath tube causing the valve clamping device to swing and shift, facilitating the surgical operation, and being beneficial to shorten the operation time and improve the operation efficiency.

[0086] The technical features of the above embodiments can be combined in any manner. To make the description concise, all possible combinations of the technical features in the above embodiments are not described, but as long as the combinations of the technical features do not exist contradictory, they should be considered as the scope of the present application.

[0087] The above embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent application. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are all within the scope of the present application. Therefore, the protection scope of the present application patent should be subject to the appended claims.

Claims

1. A valve clamping system, characterized in that, include: A valve clamp includes a base and a first proximal clip and a second proximal clip disposed on the base and capable of being retracted or expanded relative to the base. as well as A delivery device, detachably connected to the valve clamp, includes a delivery sheath, a guide wire, a first control wire, and a second control wire. The two guide wires are located at the distal end of the delivery sheath and are symmetrical about the central axis of the delivery sheath. The first control wire is connected to the first proximal clip and extends to the proximal end of the delivery sheath after passing over the two guide wires. The second control wire is connected to the second proximal clip and extends to the proximal end of the delivery sheath after passing over the two guide wires. The guide wire includes a guide member and a threading ring slidably inserted into an insertion hole in the delivery sheath. The guide member is axially extendable along the insertion hole, and one end of the guide member extends out of the insertion hole towards the valve clamp and connects to the threading ring. The threading ring is formed by winding a coil to create a closed-loop structure. Both of the aforementioned insertion holes extend from the distal end of the delivery sheath to the proximal end of the delivery sheath.

2. The valve clamping system according to claim 1, characterized in that, The distal end of the delivery sheath is symmetrically provided with two insertion holes about the central axis of the delivery sheath, and the two guide wires are slidably connected to the two insertion holes respectively.

3. The valve clamping system according to claim 1, characterized in that, The guide is a hollow conduit that allows the first and second control lines, which bypass the two guide wires, to extend through the interior of the conduit and the insertion hole to the proximal end of the delivery sheath.

4. The valve clamping system according to any one of claims 1-3, characterized in that, The delivery sheath has an axially extending cavity, through which the first control line and the second control line, after passing around the two guide wires, extend to the proximal end of the delivery sheath.

5. The valve clamping system according to claim 4, characterized in that, Both the end of the first proximal clamp away from the fixed base and the end of the second proximal clamp away from the fixed base are provided with connecting holes. After the first control line passes through the connecting hole on the first proximal clamp, the two movable ends of the first control line are connected to the two guide wires one by one and then extend through the cavity to the proximal end of the delivery sheath. After the second control line passes through the connecting hole on the second proximal clamp, the two movable ends of the second control line are connected to the two guide wires one by one and then extend through the cavity to the proximal end of the delivery sheath.

6. The valve clamping system according to claim 5, characterized in that, The number of cavities is four, and the two movable ends of the first control line and the two movable ends of the second control line are respectively inserted into the four cavities one by one.

7. The valve clamping system according to any one of claims 1-3, characterized in that, The first proximal clamp and the second proximal clamp are symmetrically arranged about the fixing base, and the end of the first proximal clamp near the fixing base and the end of the second proximal clamp near the fixing base are connected by a connecting frame.

8. The valve clamping system according to any one of claims 1-3, characterized in that, Both the first proximal clip and the second proximal clip are at least partially made of shape memory material.

9. The valve clamping system according to any one of claims 1-3, characterized in that, The valve clamping system further includes a handle and a first operating lever and a second operating lever disposed on the handle. The handle is connected to the proximal end of the delivery sheath. The first operating lever is connected to the first control line to control the first proximal clamp to retract or expand relative to the fixation seat via the first control line. The second operating lever is connected to the second control line to control the second proximal clamp to retract or expand relative to the fixation seat via the second control line.

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