CN211485094U

Movatterモバイル変換

Info

Publication number: CN211485094U
Application number: CN201921263269.3U
Authority: CN
Inventors: 戴宇峰; 潘炳跃; 李涛
Original assignee: Shanghai Hanyu Medical Technology Co ltd
Current assignee: Shanghai Hanyu Medical Technology Co.,Ltd.
Priority date: 2019-08-06
Filing date: 2019-08-06
Publication date: 2020-09-15
Anticipated expiration: 2029-08-06

Abstract

A compressible valve clamping device comprises a base, a sliding block and clamping parts, wherein the near end side of the base is provided with a butt joint part, the center of the sliding block is axially provided with a center hole penetrating through the sliding block, the sliding block comprises a first connecting part arranged at the far end, a second connecting part arranged at the near end and a middle part positioned between the first connecting part and the second connecting part, the first connecting part is connected with the butt joint part, the sliding block can move close to and away from the base in the axial direction, at least two groups of clamping parts are arranged, each group of clamping parts comprises a connecting arm, a first clamping arm and a second clamping arm, the far end of the connecting arm is movably connected with the base, the near end of the connecting arm is movably connected with one end of the first clamping arm to form a first included angle, the other end of the first clamping arm is movably connected with the sliding block, one end of the second clamping arm is connected with the other end of the first clamping arm to form a, the other end of the second clamping arm is penetrated with a pull wire. The valve clip can be compressed, greatly reducing the overall volume of the clip system.

Description

Compressible valve clamping device and clamping system thereof

Technical Field

The present invention relates to a valve clip, and more particularly to a compressible valve clip and a clipping system thereof.

Background

The mitral valve is a two-piece valve attached to the periphery of the ostium of the left ventricle (as shown in fig. 1), attached to the papillary muscles by chordae tendineae, and functions to prevent blood from the left ventricle from flowing back into the left atrium.

Mitral Regurgitation (MR) is a series of pathophysiological changes caused by the organic or functional changes in the mitral leaflets and their associated structures that cause poor coaptation of the anterior and posterior leaflets of the mitral valve, with blood flowing back from the left ventricle to the left atrium. Severe MR causes enlargement of the left ventricle, ultimately leading to left systolic dysfunction and heart failure, while left atrial pressure also increases due to regurgitation, easily leading to enlargement of the left atrium, atrial fibrillation and pulmonary hypertension. The MR prognosis is poor, the annual death rate of patients with symptoms but without operation is about 5 percent, and the annual death rate of 5 patients with severe heart failure reaches 60 percent. Meanwhile, MR is also one of the most common cardiac diseases. The incidence rates of people over 65 and 75 years of age were statistically 6.4% and 9.3%, respectively. With the development of economic society and the aging of population, the incidence rate of mitral regurgitation is in a state of obviously rising.

Surgical valve repair or replacement is considered the standard treatment for this disease. However, the surgical operation has the disadvantages of large trauma, obvious postoperative pain, slow recovery, high risk, etc., and in addition, some patients who are elderly, have a history of chest-open disease, have poor cardiac function and have complicated multi-organ dysfunction are often rejected for surgical operation because of the high surgical risk. Therefore, there is a great social and market need to develop minimally invasive, low-risk interventional therapeutic devices for MR treatment. In recent years, with the breakthrough development of valve interventional therapy technology, MR interventional devices have become one of the key directions for the development of cardiovascular devices at home and abroad.

Among them, the valve forceps developed according to the technical principle of surgical valve edge-to-edge suturing is the most certain at present because of high safety, simple technical principle and great feasibility. The principle of the surgical valve edge-to-edge sewing technology is shown in fig. 2: when the mitral valve is in regurgitation, the edges of two valve leaflets cannot be closed together to form a gap in the systole, so that the blood flow of the left ventricle returns to the left atrium from the gap; surgical edge-to-edge suturing sutures the mitral valve at a point intermediate the two leaflet edges such that the inter-leaflet space disappears or becomes smaller during systole, thereby reducing mitral regurgitation (fig. 2a), while during diastole the mitral valve opens into a bi-porous shape and blood flow into the left ventricle remains unaffected (fig. 2 b). The only minimally invasive interventional instrument internationally approved for treatment of MR on the market is MitraClip, a valve-clamping device, by Evalve.

Patent publication CN106175986A discloses a valve clamp, which discloses a valve clamp that performs a trapping clamping operation from the ventricular side of the valve. The patent is developed and used, and the device still has the defects that the operation space required for capturing the valve is too large, the device can only be operated through the ventricle side (the entrance of a wound from the apex of the heart is still large), the chordae tendineae are easy to wind, the atrial roof of the heart is easy to damage, and the clamping device is made of a rigid material and cannot be compressed and conveyed through actual operation.

Therefore, effective innovation of the prior art is needed to address the above drawbacks.

SUMMERY OF THE UTILITY MODEL

The utility model provides a develop compressible valve clamping device and clamping system thereof, the length of valve clamping device is shortened to the valve clamping device can be carried after being compressed, and very big reduction clamping system's whole volume reduces the space that valve clamping device self accounts for the ventricle side, reduces the damage that the valve clamping device probably caused heart tissue, reduces the risk that forms the thrombus. The operating space of the clamping system can be shortened, the operating direction can be changed, the capturing and clamping operation can be performed from the atrium side, the intercostal incision and the puncture of the apex are not needed, the surgical trauma is smaller, and the risk of injury to the atrium and the chordae tendineae in the surgical operation process can be reduced.

In order to achieve the above purpose, the utility model adopts the following technical scheme:

a compressible valve clamping device comprises a base, a sliding block and clamping parts, wherein the near end side of the base is provided with a butt joint part, the central axis of the sliding block is axially provided with a center hole penetrating through the sliding block, the sliding block comprises a first connecting part arranged at the far end, a second connecting part arranged at the near end and a middle part positioned between the first connecting part and the second connecting part, the first connecting part is connected with the butt joint part, the sliding block can move close to and away from the base in the axial direction, the clamping parts are at least provided with two groups, each group of clamping parts comprises a connecting arm, a first clamping arm and a second clamping arm, the far end of the connecting arm is movably connected with the base, the near end of the connecting arm is movably connected with one end of the first clamping arm to form a first included angle, and the other end of the first clamping arm is movably connected onto the sliding block, one end of the second clamping arm is connected with the other end of the first clamping arm to form a second included angle, and a pull wire penetrates through the other end of the second clamping arm;

correspondingly, the surfaces of the base, the sliding block, the connecting arm, the first clamping arm and the second clamping arm are coated with polymer films or polymer materials, and the polymer films or the polymer materials comprise PET films so as to promote endothelialization of the valve clamp implanted into a human body;

correspondingly, the butt joint part is provided with a first butt joint structure, and the first connecting part is provided with a first connecting structure matched with the first butt joint structure;

correspondingly, the first butt joint structure is a clamping block or a clamping groove arranged on the circumferential side of the butt joint part, the first connecting structure is a clamping groove or a clamping block arranged on the inner side of the far end of the first connecting part, the clamping block and the clamping groove are in clamping connection, the clamping block is pushed into the clamping groove, and the fixed connection between the first connecting part and the base is realized by means of the clamping action between the clamping block and the clamping groove;

correspondingly, the middle part is provided with a lantern ring wrapping the middle part, the lantern ring is woven by elastic materials, the elastic materials comprise nickel-titanium alloy, the lantern ring can be compressed during conveying, the overall size of the sliding block is reduced, the limiting force is removed after the sliding block is conveyed in place, and the lantern ring can automatically recover to a set shape;

correspondingly, the thickness of the near end of the middle part is larger than that of the far end of the middle part, when the sliding block is pushed towards the base so as to fold the first clamping arm, a certain included angle still exists between the second clamping arm and the sliding block, the thicker near end of the sliding block can make up the gap of the included angle at the position, a supporting force is provided for the second clamping arm, and the clamping force between the two clamping arms is improved;

correspondingly, the clamping component is integrally woven by adopting an elastic material, the elastic material comprises nickel-titanium alloy, the valve clamping device can be compressed and folded into a smaller size when being conveyed by integrally weaving the nickel-titanium alloy, on one hand, a conveying device with a smaller pipe diameter can be adopted to convey the valve clamping device, the required operation space is reduced, on the other hand, the valve is not easy to damage when the valve clamping device is used due to the flexibility of the woven material, and in addition, the sizes of the first included angle and the second included angle can be conveniently and better adjusted;

correspondingly, the connecting arm, the first clamping arm and the second clamping arm in one group of clamping parts form a Z-shaped clamp;

correspondingly, the far end of the connecting arm and the base, the near end of the connecting arm and the first clamping arm, and the first clamping arm and the sliding block are movably connected, and the movable connection mode comprises a rotating shaft structure;

correspondingly, the connecting arm is of a groove structure, the width of the groove is larger than the width of each of the first clamping arm and the second clamping arm, and when the sliding block is pushed towards the base so as to fold the first clamping arm, the groove can provide accommodating space for the first clamping arm and at least one part of the second clamping arm, so that the clamping firmness and stability of the valve clamping device are enhanced;

correspondingly, the width of the proximal end arm of the connecting arm is narrower than that of the distal end arm of the connecting arm, and the width of the proximal end is transited from the width of the proximal end to the width of the distal end, so that the valve clamping device is gradually retracted into the conveying pipe from the proximal end to the distal end;

correspondingly, the connecting arm is of a groove structure with a U-shaped outer contour;

correspondingly, clamping teeth are arranged on one side, facing the first clamping arm, of the second clamping arm, the clamping teeth are convenient for the second clamping arm to capture valve tissues, the friction force between the second clamping arm and the valve tissues can be enhanced, and the captured valve tissues are prevented from slipping out of the clamping arms;

correspondingly, the first included angle and the second included angle are respectively provided with a shaping angle a1 and a2, preferably, the angle a1 is more than or equal to 0 degree and less than or equal to 15 degrees, and the angle a2 is more than or equal to 0 degree and less than or equal to 15 degrees.

A compressible valve clipping system comprising, in addition to the aforementioned valve clipping device:

the adjustable bending catheter sheath comprises a near-end straight pipe section and a far-end bending adjusting section, and the straight pipe section and the bending adjusting section are provided with continuous first through holes communicated with the two ends;

a dilator, wherein the dilator is suitable for passing through the first through hole, the axial length of the dilator is larger than that of the adjustable bending catheter sheath, the dilator is provided with a second through hole which is communicated with two ends, and the inner diameter of the second through hole is suitable for passing through a guide wire;

a shuttle having a third through-hole communicating the two ends, the third through-hole being adapted to receive the valve clamp and at least a portion of the delivery tube, at least a portion of the third through-hole having an outer wall sized to enter the first through-hole;

a delivery pipe, which is suitable for passing through the third through hole and the first through hole, has an axial length larger than the total axial length of the adjustable bending catheter sheath and the loader, and has a fourth through hole communicated with the two ends, and the far end of the delivery pipe is detachably connected with the second connecting part;

the axial length of the push rod is greater than that of the conveying pipe, the push rod is suitable for axially moving along the fourth through hole, and the far end of the push rod is detachably connected with the butt joint part;

correspondingly, the inner proximal ends of the adjustable bending catheter sheath, the dilator, the delivery pipe and the loader are provided with hemostatic valves;

correspondingly, the conveying pipe and the pushing rod are also provided with elastic sections which can bend along with the bending of the bending adjusting section;

correspondingly, the far end of the conveying pipe is provided with at least two extension arms which are made of elastic materials, the extension arms are shaped into flaring structures, the near ends of the inner sides of the extension arms are provided with at least two clamping pieces, the two clamping pieces are arranged on the inner side walls of the extension arms in a staggered mode, the two clamping pieces are provided with corresponding pore channels, and the pore channels are used for a pushing rod to pass through;

correspondingly, the second connecting part is provided with a second connecting structure, the extension arm of the conveying pipe is provided with a third connecting structure matched with the second connecting structure, and the third connecting structure is detachably connected with the second connecting structure;

correspondingly, the second connecting structure is a bulge or a clamping hole arranged on the circumferential side of the second connecting part, the third connecting structure is correspondingly provided with a clamping hole or a bulge, and the bulge is clamped into the clamping hole or pulled out of the clamping hole, so that the connection and the disassembly of the bulge and the clamping hole are realized;

correspondingly, the outer diameter of the push rod is smaller than the inner diameter of the central hole, so that the push rod can be inserted into the central hole;

correspondingly, the butt joint part is also provided with a second butt joint structure, the push rod is provided with a fourth connecting structure matched with the second butt joint structure, and the fourth connecting structure is detachably connected with the second butt joint structure;

correspondingly, the second butt joint structure is arranged in the internal thread at the near end of the butt joint part, and the fourth connecting structure is arranged in the external thread at the far end of the push rod, so that the internal thread and the external thread are in threaded connection.

It should be noted that, in the present invention, the terms "proximal end" and "distal end" refer to the relative position with the operator during the valve operation, and the judgment is made according to the relative position with the operator during the normal use process, wherein the proximal end refers to the end close to the operator, and the distal end refers to the end away from the operator. The term "shape-fixing" refers to the shape or included angle of a structure in a natural structure without external force after an earlier process, for example, the "shape-fixing included angle" refers to the angle naturally formed between a first clamping arm or a second clamping arm without external force. The elastic material is a material which is deformed by the stress of an object and the object restores the original shape after the acting force is removed. The elastic section is elastically deformed under the action of external force, and can automatically restore to the original shape after the external force is removed.

The utility model has the advantages that:

1) in the valve clamping device, except that the base and the sliding block are of rigid structures to keep specific connection and shape, the rest parts are made of elastic materials and can be integrally woven, so that the damage of the valve clamping device to heart tissues is reduced due to the flexibility of the elastic materials, the risk of forming thrombus is reduced, the valve clamping device can be compressed for conveying, and the conveying volume is greatly reduced;

2) the clamping components can be arranged integrally, the structure is simpler and more stable, one end of the first clamping arm is movably arranged on the sliding block, the sizes of the first included angle and the second included angle are controlled through the sliding of the sliding block, the size of the second included angle can be changed independently through the pull wire to realize the capture of the valve, the required operation space is smaller, and the requirement of simultaneously capturing the valve on one side or two sides is realized through independent or simultaneous tightening or loosening of the pull wire;

3) the delivery system can puncture the interatrial septum after entering the right atrium from the femoral vein and output from the left atrium, so that the existing delivery path is changed, and the surgical trauma is smaller;

4) when the valve is captured, the first clamping arm, the connecting arm and the base are positioned on the left ventricle side, the second clamping arm is positioned on the left atrium side, the space where the structure is positioned is shared, the structure is prevented from being intensively placed in the same side space to increase the pressure of the space on the side, when the valve is captured, the valve tissue can be captured by recovering the shaping angles of the first clamping arm and the second clamping arm, the operation range is small, and the risk of damage to chordae tendinae and the left atrium top is greatly reduced;

5) conveyer pipe and propelling movement pole can dismantle with base and slider respectively and be connected, and this connection structure is simple for connection between them is more simple and convenient with the dismantlement.

Drawings

FIG. 1 is a schematic view of a heart anatomy;

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

FIG. 2 is a schematic diagram of a surgical mitral valve edge-to-edge suturing technique, wherein 2a is mitral valve closing and 2b is mitral valve opening;

fig. 3a-3c are schematic structural views of a valve clip according to an embodiment of the present invention;

fig. 4a-4b are schematic structural views of a base according to an embodiment of the present invention;

fig. 5a-5c are schematic structural views of a slider according to an embodiment of the present invention;

fig. 6a-6c are schematic structural views of a connecting arm according to an embodiment of the present invention;

fig. 7a-7b are schematic views of a connection structure of a first clamping arm and a second clamping arm according to an embodiment of the present invention;

figures 8a-8b are schematic views of a delivery tube, push rod and valve clip according to an embodiment of the present invention when connected;

fig. 9a is a schematic view of a valve clip according to an embodiment of the present invention in a first closed state;

fig. 9b is a schematic view of a valve clip according to an embodiment of the present invention in a second collapsed state;

fig. 10 is a schematic structural view of an adjustable bendable catheter sheath according to an embodiment of the present invention;

fig. 11 is a schematic structural view of a dilator according to an embodiment of the present invention;

fig. 12 is a schematic structural view of a loader according to an embodiment of the present invention;

fig. 13a is a schematic view of the overall structure of the conveying pipe according to an embodiment of the present invention;

fig. 13b is an enlarged view of an extension arm of a carrier pipe according to an embodiment of the present invention;

fig. 13c is a schematic view illustrating a state of the push rod inserted into the conveying pipe according to an embodiment of the present invention;

fig. 14 is a schematic structural diagram of a push rod according to an embodiment of the present invention;

FIG. 15 is an assembled schematic view of the adjustable bending sheath, dilator and guidewire;

FIG. 16 is an assembled schematic view of the adjustable bending sheath, the delivery tube and the push rod;

the bending of the structure in FIGS. 10-16 is merely illustrative to show its flexible nature;

in the figure:

20. a base; 201. a docking portion; 202. a clamping block; 203. an internal thread;

30. a slider; 301. a central bore; 302. a first connection portion; 303. a middle part; 304. a second connecting portion; 305. a protrusion;

401. a connecting arm; 402. a first clamping arm; 403. a second clamping arm; 404. clamping teeth;

50. a pull wire;

601. a horizontal axis; 602. a shaft hole;

701. a straight pipe section; 702. bending section adjustment;

80. a dilator;

90. a guide wire;

100. a loader;

110. a delivery pipe; 1101. an extension arm; 1102. a clamping piece; 1103. a duct; 1104. a clamping hole;

120. a push rod;

130. a hemostatic valve.

Detailed Description

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and to simplify the description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the present invention.

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

In the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "fixed" are to be construed broadly and may, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art.

In one embodiment of the present invention, the compressible valve clamping system comprises a valve clamp, an adjustable curved catheter sheath, adilator 80, aloader 100, adelivery tube 110, and apush rod 120; wherein,

as shown in fig. 3a-3c, the valve clamping device includes abase 20, a slidingblock 30 and a clamping component, the surfaces of thebase 20, the slidingblock 30 and the clamping component are coated with a polymer film or a polymer material, in this embodiment, a PET film is coated on the surface to promote endothelialization of the valve clamping device after being implanted into a human body;

as shown in fig. 4a and 4b, thedocking portion 201 is disposed on the proximal side of thebase 20, preferably, thedocking portion 201 is disposed at the center of the proximal side of thebase 20, thedocking portion 20 at least has a first docking structure and a second docking structure, the first docking structure is connected to the distal end of theslider 30, the second docking structure is connected to the distal end of thepush rod 120, in this embodiment, for simplicity, the first docking structure is alatch 202 disposed on the circumferential side of thedocking portion 201, and the second docking structure is aninternal thread 203 disposed inside thedocking portion 201.

As shown in fig. 5a-5c, the central axis of the slidingblock 30 is provided with acentral hole 301 penetrating through the slidingblock 30, thecentral hole 301 is used for thepush rod 120 to pass through, and the slidingblock 30 can move towards and away from the base 20 in the axial direction, so that the clamping component has two folding states by virtue of the movement of the slidingblock 30, the slidingblock 30 is in a first folding state when being maximally closed to thebase 20, and is in a second folding state when being maximally away from thebase 20, the first folding state is used for further clamping the valve tissue after the valve clamp captures the valve tissue, and the valve clamp in the second folding state has a smaller outer diameter, thereby being more beneficial to the delivery of the valve clamp in thedelivery pipe 110. Theslider 30 includes a first connectingportion 302 disposed at the distal end, a second connectingportion 304 disposed at the proximal end, and amiddle portion 303 located between the first connectingportion 302 and the second connectingportion 304, the first connectingportion 302 is used for connecting with a first docking structure in thedocking portion 201, and therefore, the first connectingportion 302 has a first connecting structure adapted to the first docking structure, which is configured as alatch 202 in this embodiment, and therefore, the first connecting structure is a latch slot disposed at the inner side of the distal end of the first connectingportion 302. Thesecond coupling portion 304 has a second coupling structure for detachable coupling with the distal end of thedelivery tube 110, and in the present embodiment, the second coupling structure is aprotrusion 305 provided on the circumferential side of thesecond coupling portion 304 for the sake of simplicity of description. The thickness of the proximal end of themiddle portion 303 is greater than the thickness of the distal end thereof, and when theslider 30 is pushed toward the base 20 so as to draw thefirst clamping arm 402 and thesecond clamping arm 403 together, a certain included angle still exists between thesecond clamping arm 403 and theslider 30, and the thicker proximal end of theslider 30 can make up for the gap of the included angle at the position, so as to provide a supporting force for thesecond clamping arm 403 and improve the clamping force between the two clamping arms. Themiddle part 303 is also provided with a lantern ring wrapping themiddle part 303, the lantern ring is woven by elastic materials, during conveying, the lantern ring is compressed and limited in the pipe diameter for conveying, after the conveying is in place, the limiting force is removed, and the lantern ring can automatically recover the shaping shape;

the other end of thesecond clamping arm 403 is provided with the pullingwire 50, the two pullingwires 50 respectively arranged on the two second clampingarms 403 extend from the conveyingpipe 110 to the outside of the body, and the pullingwire 50 is tightened or loosened outside the body, so as to adjust the size of the second included angle a 2. As shown in fig. 6a to 6c, the connectingarm 401 is a groove structure, and the width of the groove is greater than the respective widths of thefirst clamping arm 402 and thesecond clamping arm 403, and when theslider 30 is pushed toward the base 20 to fold thefirst clamping arm 402 and thesecond clamping arm 403, the groove can provide a receiving space for thefirst clamping arm 402 and at least a portion of thesecond clamping arm 403, so as to enhance the clamping firmness and stability of the valve clamp. Furthermore, the proximal arm width of the connectingarm 401 can be limited to be narrower than the distal arm width thereof, and the transition from the proximal narrow to the distal wide facilitates the gradual retraction of the valve clip into thedelivery tube 110 from the proximal to the distal, in short, the connectingarm 401 is a groove structure with a "U" shaped outer profile;

the proximal ends of the adjustable bending sheath,dilator 80,shuttle 100, anddelivery tube 110 are each provided with ahemostasis valve 130, wherein,

as shown in fig. 10, the adjustable bending catheter sheath further comprises a proximalstraight pipe section 701 and adistal bending section 702, and thestraight pipe section 701 and thebending section 702 have a continuous first through hole communicating the two ends. The bend-adjustingsection 702 is a bendable conduit section, and is made of an elastic material, and the bend-adjusting principle is as follows: through a traction wire, the one end of this traction wire is fixed in the port department of transferringcurved section 702 through the stay wire ring, and the other end is worn out from adjustable curved pipe sheath near-end, through the elasticity operation to the traction wire, realizes adjusting the crookedness ofcurved section 702, for example, can refer to the adjustable curved sheath pipe that patent number is 201310397312.6 and have this adjustable curved sheath pipe's conveying system, because of the structure of transferring curved and the operation of adjustable curved pipe sheath have been prior art, the utility model discloses in just not explaining too much. The utility model adopts the adjustable bending conduit sheath as the conveying device of the valve clamping device, and the reason is that the conveying direction of the valve clamping device is not consistent with the position of the mitral valve because the valve clamping device is conveyed from the right atrium to the left atrium, and the output direction of the valve clamping device is adjusted to the position of the mitral valve through the adjustment of thebending section 702;

as shown in fig. 11, thedilator 80 is adapted to pass through the first through hole, the axial length of thedilator 80 is greater than that of the adjustable bending catheter sheath, and thedilator 80 has a second through hole communicating with both ends, the inner diameter of the second through hole is adapted to pass through theguide wire 90;

as shown in FIG. 12, thecartridge 100 has a third aperture therethrough, the third aperture being adapted to receive the valve clamp and at least a portion of thedelivery tube 110, at least a portion of the third aperture having an outer wall sized to pass into the first aperture, thecartridge 100 serving as only one of the transfer structures of the valve clamp;

as shown in fig. 13a, thedelivery tube 110 is adapted to pass through the third through hole and the first through hole, thedelivery tube 110 further has an elastic section, the axial length of thedelivery tube 110 is greater than the total axial length of the adjustable bending catheter sheath and theloader 100, and thedelivery tube 110 has a fourth through hole communicating two ends, the distal end of thedelivery tube 110 is detachably connected with the second connecting structure, whereas in the present embodiment, the second connecting structure is provided with theprotrusion 305, therefore, the distal end of thedelivery tube 110 needs to have a connecting structure matched with theprotrusion 305, for this purpose, in the present embodiment, as shown in fig. 13b and 13c, the distal end of thedelivery tube 110 is provided with at least twoextension arms 1101, and theextension arms 1101 are provided with the locking holes 1104, the number and positions of the locking holes 1104 and theprotrusion 305 are corresponding, so that the lockingholes 1104 are adapted to be locked by theprotrusion 305, thereby realizing the connection between the delivery. Meanwhile, considering that after the slider 30 is conveyed in place, the connection relationship between the conveying pipe 110 and the slider 30 needs to be released, on the premise of the aforementioned structure, the extension arm 1101 is made of an elastic material, the elastic material includes nickel-titanium alloy, spring steel, and the like, the extension arm 1101 is shaped into a flared structure, at least two clamping pieces 1102 are arranged at the proximal end of the inner side of the extension arm 1101, the two clamping pieces 1102 are arranged on the opposite inner side walls of the extension arm 1101 in a staggered manner, corresponding hole channels 1103 are arranged on the two clamping pieces 1102, the hole channels 1103 are used for the push rod 120 to pass through, therefore, the extension arm 1101 is connected with the push rod 120 by means of the clamping pieces 1102, so that the two extension arms 1101 keep a certain distance, and the protrusion 305 can be stably clamped in the clamping hole 1104, when the connection relationship between the conveying pipe 110 and the slider 30 needs to be removed, the push rod 120 is withdrawn from the hole 1103 to remove the connection relationship between the push rod, the extension arm 1101 recovers the shape of the extension arm, so that the protrusion 305 is disengaged from the clamping hole 1103, and the disassembly work is realized;

as shown in fig. 14, thepush rod 120 also has an elastic section, and the axial length of thepush rod 120 is greater than the axial length of the conveyingpipe 110, and is suitable for performing axial movement along the fourth through hole, and the outer diameter of thepush rod 120 is smaller than the inner diameter of thecentral hole 301, so that thepush rod 120 can be inserted into thecentral hole 301, the distal end of thepush rod 120 has a fourth connection structure, and thepush rod 120 is detachably connected with the second butt-joint structure of the butt-joint portion 201 through the fourth connection structure, and in this embodiment, the second butt-joint structure is aninternal thread 203, so that the fourth connection structure is set as an external thread, the external thread is matched with theinternal thread 203, and the threaded connection and the detachment of thepush rod 120 and the.

According to the valve clamping system of the embodiment, the following embodiments can be obtained:

1) assembly ofpush rod 120,delivery tube 110 and loader 100: inserting thepush rod 120 from the proximal end of thedelivery tube 110 into the fourth through hole from the distal end of thepush rod 120, and then inserting thedelivery tube 110 from the proximal end of theloader 100 into the third through hole from the distal end of thedelivery tube 110;

2) assembly between theslider 30 and the delivery tube 110: as shown in fig. 8a and 8b, after thefastening hole 1104 on theextension arm 1101 of the conveyingpipe 110 corresponds to theprotrusion 305 on theslider 30, thepush rod 120 is inserted into the fourth through hole of the conveyingpipe 110, and thepush rod 120 is ensured to simultaneously pass through the hole channel 1103 of thefastening member 1102, so as to perform necking limitation on theextension arm 1101 in the flaring state, so that theprotrusion 305 is just fastened into thefastening hole 1104;

3) assembling between the base 20 and the push rod 120: as shown in fig. 8a and 8b, the pushingrod 120 is further pushed along the axial direction of thedelivery tube 110 until the external thread of the pushingrod 120 is completely screwed into theinternal thread 203 of thedocking portion 201 of thebase 20;

4) introducing an adjustable curved catheter sheath into the left atrium: as shown in fig. 15, the distal end of theguide wire 90 is first introduced into the body by using a puncture tool such as a puncture needle, the distal end of theguide wire 90 is continuously introduced into the left atrium, then the puncture needle is removed, thedilator 80 is inserted into the first through hole of the adjustable bending sheath, the proximal end of theguide wire 90 is passed through the second through hole from the distal end of thedilator 80, so that thedilator 80 can introduce the adjustable bending sheath into the left atrium under the guidance of the guide wire 90 (the distal end of the adjustable bending sheath is an adjustable bending section, which is made of a flexible material and has low hardness, and cannot be directly inserted into the femoral vein, so that thedilator 80 with a conical head and high hardness is required to guide, which is a conventional medical operation), and then the distal end of theguide wire 90 is pulled into thedilator 80, and theguide wire 90 and thedilator 80 are withdrawn from the adjustable;

5) folding operation of the clamping component: the clamping component has two folding states, as shown in fig. 9a, the slidingblock 30 is in the first folding state when being drawn close to the base 20 to the maximum extent, as shown in fig. 9b, the slidingblock 30 is in the second folding state when being far away from the base 20 to the maximum extent, and both folding states can be used for conveying, but considering that the outer diameter of the valve clamp in the second folding state is smaller in practice, the conveying of the valve clamp in the conveyingpipe 110 is more facilitated, so the clamping device is conveyed in the second folding state in the embodiment;

6) transfer operation of the loader: as shown in fig. 16, the valve clip in the folded state is completely retracted into theloader 100, the distal end of theloader 100 is inserted into the first through hole of the adjustable bending catheter sheath, and the valve clip is pushed into the first through hole of the adjustable bending catheter sheath by the loader 100 (the reason why the valve clip is not pushed directly into the adjustable bending catheter sheath is that it is inconvenient to directly feed the valve clip into the adjustable bending catheter sheath from the proximal end because the proximal end of the adjustable bending catheter sheath is provided with ahemostatic valve 130 and the like);

7) delivering a valve clip to the mitral valve and performing capture of valve tissue: pushing the valve clamping device into the left atrium along the adjustable bending catheter sheath, operating thebending section 702 of the adjustable bending catheter sheath to bend to the position of the mitral valve, bending thedelivery pipe 110 and thepush rod 120 along with the adjustable bending catheter sheath, continuing to push until the clamping part completely detaches from the adjustable bending catheter sheath, recovering from the folded state to the shaped state, and then tightening thepull wires 50 penetrating through the second clampingarms 403, ensuring that thebase 20, the connectingarm 401 and the first clampingarms 402 enter the left ventricle, and simultaneously enabling at least a part of the second clampingarms 403 to be positioned in the left atrium, at the moment, loosening the pull wires 50 (the twopull wires 50 penetrating through the two second clampingarms 403 can be independently tightened or loosened, and can also be simultaneously tightened or loosened), simultaneously capturing valve tissues by means of the clampingteeth 404, and preventing the captured valve tissues from slipping out from the clamping arms;

8) further clamping of the captured valve tissue: the valve clamping device is in a first folding state, specifically, thepush rod 120 is kept in the current position, the base 20 connected with thepush rod 120 is kept still, thedelivery pipe 110 is continuously pushed, the slidingblock 30 gradually approaches thebase 20 under the pushing force of thedelivery pipe 110, and finally the slidingblock 30 is connected with the base 20 through the clamping groove and theclamping block 202, at the moment, the clamping component is in the first folding state, so that a second included angle a2 between the first clampingarms 402 and between the second clampingarms 403 is greatly reduced, the clamping force on valve tissues is greatly increased, and as the shaping angle of the first included angle and the second included angle is set to be close to 0 degree, the clamping state at the moment just conforms to the shaping form of the first included angle, and the current clamping state can be well kept;

9) the connection state between the pushingrod 120 and thebase 20 and between thedelivery pipe 110 and theslider 30 is released: and reversely rotating thepush rod 120, screwing the external thread of thepush rod 120 out of theinternal thread 203 of the buttjoint part 201 and withdrawing thedelivery pipe 110, simultaneously withdrawing the limitingextension arm 1101, immediately recovering the flaring structure of theextension arm 1101, then releasing the connection between thedelivery pipe 110 and theslider 30, withdrawing thedelivery pipe 110 and thepush rod 120 from the adjustable bent catheter sheath, and finally withdrawing the adjustable bent catheter sheath.

It should be noted that the order of the above-described operational steps is not exclusive, as long as it is feasible according to industry operational standards or common general knowledge.

The foregoing has described in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be devised by those skilled in the art in light of the teachings of the present invention without undue experimentation. Therefore, the technical solutions that can be obtained by a person skilled in the art through logic analysis, reasoning or limited experiments based on the prior art according to the concepts of the present invention should be within the scope of protection defined by the claims.

Claims

1. A compressible valve binder, comprising: the clamping mechanism comprises a base, a sliding block and clamping components, wherein a butt joint part is arranged on the near end side of the base, a center hole penetrating through the sliding block is axially arranged in the center of the sliding block, the sliding block comprises a first connecting part arranged at the far end, a second connecting part arranged at the near end and a middle part positioned between the first connecting part and the second connecting part, the first connecting part and the butt joint part are connected, the sliding block can move close to and away from the base in the axial direction, at least two groups of the clamping components are arranged, each group of the clamping components comprises a connecting arm, a first clamping arm and a second clamping arm, the far end of the connecting arm is movably connected with the base, the near end of the connecting arm is movably connected with one end of the first clamping arm to form a first included angle, the other end of the first clamping arm is movably connected with the sliding block, one end of the second clamping arm is connected with the other end of the first clamping arm, a second included angle is formed, and a pull wire penetrates through the other end of the second clamping arm.

2. The compressible valve clip of claim 1, wherein: the base, the slider, the linking arm, first clamp arm and the surface of second clamp arm all coats and has been coated with polymer film or macromolecular material, and polymer film or macromolecular material include the PET membrane.

3. The compressible valve clip of claim 1, wherein: the butt joint part is provided with a first butt joint structure, and the first connecting part is provided with a first connecting structure matched with the first butt joint structure.

4. A compressible valve clip according to claim 3 wherein: the first butt joint structure is a clamping block clamping groove formed in the circumferential side of the butt joint part, the first connecting structure is a clamping groove or a clamping block formed in the inner side of the far end of the first connecting part, and the clamping block and the clamping groove are connected in a buckling mode.

5. The compressible valve clip of claim 1, wherein: the middle part is provided with the parcel the lantern ring of middle part, the lantern ring adopts elastic material to weave to form, elastic material includes nickel titanium alloy.

6. The compressible valve clip of claim 1, wherein: the thickness of the proximal end of the middle portion is greater than the thickness of the distal end thereof.

7. The compressible valve clip of claim 1, wherein: the clamping component is integrally woven by elastic materials, and the elastic materials comprise nickel-titanium alloy.

8. The compressible valve clip of claim 1, wherein: the connecting arm, the first clamping arm and the second clamping arm in the group of clamping parts form a Z-shaped clamp.

9. The compressible valve clip of claim 1, wherein: the connecting arm distal end with between the base, the connecting arm near-end with between the first clamping arm with be swing joint between the slider, swing joint's mode is including adopting the pivot structure.

10. The compressible valve clip of claim 1, wherein: the connecting arm is of a groove structure, and the width of the groove is larger than the width of each of the first clamping arm and the second clamping arm.

11. The compressible valve clip of claim 1, wherein: the proximal arm of the connecting arm is wider than its distal arm.

12. The compressible valve clip of claim 1, wherein: the connecting arm is of a groove structure with a U-shaped outer contour.

13. The compressible valve clip of claim 1, wherein: and one side of the second clamping arm, which faces the first clamping arm, is provided with clamping teeth.

14. The compressible valve clip of claim 1, wherein: the first included angle and the second included angle are respectively provided with a shaping angle a1 and a2, a1 is more than or equal to 0 degree and less than or equal to 15 degrees, and a2 is more than or equal to 0 degree and less than or equal to 15 degrees.

15. A clamping system for a compressible valve clamp according to any one of claims 1 to 14, wherein: in addition to the valve holders described above, further comprising,

the axial length of the push rod is greater than that of the conveying pipe and is suitable for axial movement along the fourth through hole, and the far end of the push rod is detachably connected with the butt joint part.

16. The compressible valve clamping system of claim 15, wherein: hemostatic valves are arranged at the inner proximal ends of the adjustable bending catheter sheath, the dilator, the delivery pipe and the loader.

17. The compressible valve clamping system of claim 15, wherein: the conveying pipe and the pushing rod are also provided with elastic sections which can be bent along with the bending of the bending adjusting sections.

18. The compressible valve clamping system of claim 15, wherein: the distal end of conveyer pipe sets up two at least extension arms, the extension arm adopts elastic material, just the extension arm is stereotyped for the flaring structure, in the inboard near-end of extension arm is provided with two at least joint spare, two the joint spare stagger set up in on the inside wall that the extension arm is relative, two be provided with corresponding pore on the joint spare.

19. The compressible valve clamping system of claim 18, wherein: the second connecting part is provided with a second connecting structure, the extension arm of the conveying pipe is provided with a third connecting structure matched with the second connecting structure, and the third connecting structure is detachably connected with the second connecting structure.

20. The compressible valve clamping system of claim 19, wherein: the second connecting structure is a bulge or a clamping hole arranged on the circumferential side of the second connecting part, and the third connecting structure is correspondingly arranged into a clamping hole or a bulge.

21. The compressible valve clamping system of claim 15, wherein: the outer diameter of the push rod is smaller than the inner diameter of the central hole.

22. The compressible valve clamping system of claim 15, wherein: the butt joint part is further provided with a second butt joint structure, the push rod is provided with a fourth connecting structure matched with the second butt joint structure, and the fourth connecting structure is detachably connected with the second butt joint structure.

23. The compressible valve clamping system of claim 22, wherein: the second butt joint structure is arranged in an internal thread at the near end of the butt joint part, and the fourth connecting structure is arranged in an external thread at the far end of the push rod and is in threaded connection with the external thread through the internal thread.