Compressible valve clamp and clamping system thereofTechnical Field
The present invention relates to valve clamps, and more particularly to a compressible valve clamp and a clamping system thereof.
Background
The mitral valve is a two-piece valve attached to the periphery of the left atrioventricular orifice (as shown in fig. 1), and chordally attached to the papillary muscles, has the effect of preventing blood from flowing back into the left atrium.
Mitral Regurgitation (MR) is a series of pathophysiological changes caused by poor anterior and posterior She Wenge of the mitral valve due to organic or functional changes in the mitral valve leaflets and their associated structures, and the regurgitation of blood flow from the left ventricle to the left atrium. Severe MR causes left ventricular enlargement, eventually leading to left heart contractile failure dysfunction and heart failure, while left atrial pressure also increases due to regurgitation, easily leading to left atrial enlargement, atrial fibrillation, and pulmonary hypertension. MR prognosis is poor, the annual mortality rate of symptomatic and non-operating persons is around 5%, and the 5-year mortality rate of severe heart failure patients reaches 60%. Meanwhile, MR is also one of the most common heart diseases. The incidence of people over the ages of 65 and 75 was counted as 6.4% and 9.3%, respectively. With the development of the economic society and the aging of the population, the incidence of mitral regurgitation is in a markedly rising state.
Surgical valve repair or replacement is considered a standard treatment for this disease. However, surgery has the disadvantages of large trauma, obvious postoperative pain, slow recovery, high risk, and the like, and in addition, some patients who are old, have history of chest opening, have poor cardiac function, and incorporate multiple organ insufficiency are often rejected from the surgery because of the large risk of the surgery. Therefore, there is a great social and market need to develop minimally invasive, low risk, interventional therapeutic devices for the treatment of MR. In recent years, with the breakthrough development of valve interventional therapy technology, an MR interventional instrument has become one of the important directions for developing domestic and foreign cardiovascular instruments.
Among them, the valve clamping mechanism developed according to the surgical valve edge-to-edge suturing technology principle is most affirmed at present because of high safety, simple technology principle and high feasibility. The surgical valve edge-to-edge sewing technique principle is shown in fig. 2: when the mitral valve is in regurgitation, the edges of two valve leaflets cannot be closed in a closing way in the systole, so that gaps exist, and blood flow of the left ventricle returns to the left atrium from the gaps; surgical edge-to-edge suturing sutures the middle points of the two leaflet edges of the mitral valve such that the inter-leaflet space disappears or becomes smaller during systole, thereby reducing mitral regurgitation (fig. 2 a), while the diastole mitral valve opens into a double orifice, leaving the flow of blood into the left ventricle unaffected (fig. 2 b). The only minimally invasive interventional instrument commercially available from International for therapeutic MR is MITRACLIP from Evalve, which is a valve clamping device.
Patent publication number CN106175986a discloses a valve clamp which discloses a valve clamp that captures the clamping operation from the ventricular side of the valve. The patent is developed and used, and the defects that the operation space required by capturing the valve is too large, the operation can only be performed through the ventricular side (the wound entering from the apex is still bigger), chordae tendineae are easy to wind, the top of a heart is easy to damage, the clamp is made of rigid materials and cannot be compressed and conveyed exist in the practical operation are found.
Accordingly, there is a need for effective innovations in the art that address the above shortcomings.
Disclosure of Invention
The invention aims to develop a compressible valve clamp and a clamp system thereof, the length of the valve clamp is shortened, the valve clamp can be conveyed after being compressed, the whole volume of the clamp system is greatly reduced, the space of the valve clamp occupying the ventricle side is reduced, the possible damage of the valve clamp to heart tissue is reduced, and the risk of thrombus formation is reduced. The operation space of the clamping system can be shortened, the operation direction is changed, capturing and clamping operations are carried out from the side of the atrium, intercostal and puncture of the apex of the heart are not needed to be cut, the operation wound is smaller, and the damage risk to the atrium and chordae tendineae in the operation process can be reduced.
In order to achieve the above purpose, the invention adopts the following technical scheme:
The compressible valve clamp comprises a base, a sliding block and a clamping component, wherein a butt joint part is arranged at the proximal end side of the base, a central hole penetrating through the sliding block is axially arranged at the center of the sliding block, the sliding block comprises a first connecting part arranged at the distal end, a second connecting part arranged at the proximal end and a middle part arranged 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 far away from the base in the axial direction of the sliding block, at least two groups of clamping components are arranged, each group of clamping components comprises a connecting arm, a first clamping arm and a second clamping arm, the distal end of the connecting arm is movably connected with the base, the proximal 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 second included angle, and the other end of the second clamping arm is movably connected with 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 a polymer film or a polymer material, wherein the polymer film or the polymer material comprises a PET film so as to promote endothelialization of the valve clamp after being implanted into a human body;
Correspondingly, the abutting part is provided with a first abutting structure, and the first connecting part is provided with a first connecting structure matched with the first abutting 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 is in clamping connection with the clamping groove, 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 for wrapping the middle part, the lantern ring is formed by weaving an elastic material, the elastic material comprises nickel-titanium alloy, the lantern ring can be compressed during conveying, the whole volume of the sliding block is reduced, and after the sliding block is conveyed in place, the limiting force is removed, so that the lantern ring can restore the shaping shape by itself;
Correspondingly, when the thickness of the proximal end of the middle part is larger than that of the distal end of the middle part, and the sliding block is pushed towards the direction of 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, and the thicker sliding block proximal end can make up for the gap of the included angle at the position, so that 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 elastic materials, the elastic materials comprise nickel-titanium alloy, and the valve clamp can be compressed and folded into smaller volume when being conveyed by adopting the nickel-titanium alloy, so that on one hand, the valve clamp can be conveyed by adopting a conveying device with smaller pipe diameter, the required operation space is reduced, on the other hand, the valve is not easy to damage when the valve clamp is used due to the softness of the woven materials, and in addition, the size of a first included angle and a second included angle can be conveniently and well adjusted;
correspondingly, the connecting arm, the first clamping arm and the second clamping arm in one group of the clamping components form a Z-shaped clamp;
Correspondingly, the distal end of the connecting arm is movably connected with the base, the proximal end of the connecting arm is movably connected with the first clamping arm, and the first clamping arm is movably connected with the sliding block by adopting 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 to the direction of the base so as to fold the first clamping arm, the groove can provide an accommodating space for the first clamping arm and at least one part of the second clamping arm, so that the firmness and the stability of clamping of the valve clamp are enhanced;
correspondingly, the width of the proximal arm of the connecting arm is smaller than that of the distal arm of the connecting arm, and the transition from the narrow of the proximal end to the wide of the distal end is convenient for the gradual retraction of the valve clamp into the delivery tube from the proximal end to the distal end;
correspondingly, the connecting arm is of a groove structure with a U-shaped outer contour;
Correspondingly, the side, facing the first clamping arm, of the second clamping arm is provided with clamping teeth, the clamping teeth facilitate the second clamping arm to capture valve tissues, friction force between the second clamping arm and the valve tissues can be enhanced, and the captured valve tissues are prevented from slipping out from the clamping arms;
Correspondingly, the first included angle and the second included angle are respectively provided with a shaping angle a1 and a2, and preferably, 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.
A compressible valve clip system comprising, in addition to the aforementioned valve clip:
the adjustable bending catheter sheath comprises a straight tube section at the proximal end and a bending adjustment section at the distal end, wherein the straight tube section and the bending adjustment section are provided with continuous first through holes communicated with two ends;
a dilator adapted to pass through the first throughbore, the dilator having an axial length greater than the axial length of the adjustable bend catheter sheath, and having a second throughbore communicating two ends, the second throughbore having an inner diameter adapted to pass through a guidewire;
A loader having a third through hole communicating two ends, the third through hole adapted to receive the valve clamp and at least a portion of the delivery tube, an outer wall of at least a portion of the third through hole sized to be able to enter the first through hole;
a delivery tube adapted to pass through the third through hole and the first through hole, the axial length of the delivery tube being greater than the total axial length of the adjustable catheter sheath and the loader, the delivery tube having a fourth through hole communicating two ends, the distal end of the delivery tube and the second connection portion being detachably connected;
The axial length of the pushing rod is greater than that of the conveying pipe, the pushing rod is suitable for axial movement along the fourth through hole, and the distal end of the pushing rod is detachably connected with the abutting part;
correspondingly, hemostatic valves are arranged at the inner proximal ends of the adjustable catheter sheath, the expander, the conveying pipe and the loader;
Correspondingly, the conveying pipe and the pushing rod are also provided with elastic sections, and the elastic sections can be bent along with the bending of the bending section;
Correspondingly, the distal end of the conveying pipe is provided with at least two extension arms, the extension arms are made of elastic materials, the extension arms are shaped into flaring structures, the proximal end of the inner side of each extension arm is provided with at least two clamping pieces, the two clamping pieces are arranged on opposite inner side walls of the extension arm in a staggered manner, and the two clamping pieces are provided with corresponding pore channels for pushing rods 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 arranged as a clamping hole or a bulge, and the connection and the disassembly of the second connecting structure and the third connecting structure are realized by clamping the bulge into the clamping hole or releasing the bulge from the clamping hole;
Correspondingly, the outer diameter of the pushing rod is smaller than the inner diameter of the central hole, so that the pushing rod can be inserted into the central hole;
Correspondingly, the butt joint part is also provided with a second butt joint structure, the pushing 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 an internal thread arranged at the proximal end of the butt joint part, the fourth connecting structure is an external thread arranged at the distal end of the push rod, and the second butt joint structure is in threaded connection with the external thread through the internal thread.
In the present invention, the terms "proximal" and "distal" refer to the end of the valve that is closer to the operator and the end that is farther from the operator, respectively, and are determined according to their relative positions with respect to the operator during normal use. The "shaping" refers to the shape or angle that the structure takes on under the natural structure without external force through the earlier process, for example, the "shaping angle" refers to the angle that the first or second clamping arms take on naturally without external force. The elastic material refers to a material which is deformed by force and returns to the original shape after the acting force is removed. The elastic section is elastically deformed under the action of external force, and the elastic section can be automatically restored to the original shape after the external force is removed.
The beneficial effects of the invention are as follows:
1) In the valve clamp, except that the base and the sliding block are of rigid structures so as to keep specific connection and shape, the rest parts are made of elastic materials and can be integrally woven, and due to the softness of the elastic materials, the possible damage of the valve clamp to heart tissues is reduced, the risk of thrombus formation is reduced, and the valve clamp can be compressed and conveyed, so that the conveying volume is greatly reduced;
2) The clamping components can be integrally arranged, the structure is simpler and more stable, as one end of the first clamping arm is movably arranged on the sliding block, the first included angle and the second included angle are controlled through the sliding of the sliding block, the valve can be captured by independently changing the second included angle through the pull wire, the required operation space is smaller, and the requirement of capturing the valve on one side or two sides simultaneously can be realized by independently or simultaneously tightening or loosening the pull wire;
3) The delivery system can penetrate the atrial 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 operation wound is smaller;
4) When the valve is captured, the first clamping arm, the connecting arm and the base are positioned at the left ventricle side, the second clamping arm is positioned at the left atrium side, the space where the structure is positioned is shared, the structure is prevented from being intensively placed in the space at the same side to increase the pressure of the space at the side, and 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, so that the operation range is small, and the damage risk to chordae tendineae and the left atrium top is greatly reduced;
5) The conveying pipe and the pushing rod are detachably connected with the base and the sliding block respectively, and the connecting structure is simple, so that the connection and the detachment of the conveying pipe and the pushing rod are simpler and more convenient.
Drawings
FIG. 1 is a schematic representation of the anatomy of a heart;
In the figure: 1 is an upper vena cava, 2 is a lower vena cava, 3 is a right atrium, 4 is a tricuspid valve, 5 is a right ventricle, 6 is a pulmonary valve, 7 is a pulmonary artery, 8 is a pulmonary vein, 9 is a left atrium, 10 is a mitral valve, 11 is a left ventricle, 12 is an aortic valve, 13 is an aorta, 14 is a descending aorta, 15 is an oxygenated blood flow direction, and 16 is an 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 closure and 2b is mitral valve patency;
FIGS. 3a-3c are schematic illustrations of the construction of a valve clip according to an embodiment of the present invention;
FIGS. 4a-4b are schematic views of a base according to an embodiment of the present invention;
FIGS. 5a-5c are schematic views illustrating a structure of a slider according to an embodiment of the present invention;
FIGS. 6a-6c are schematic illustrations of the structure of a connecting arm according to an embodiment of the present invention;
FIGS. 7a-7b are schematic views showing the 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 illustrations 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 in a first collapsed state according to an embodiment of the present invention;
FIG. 9b is a schematic view of a valve clip in a second collapsed state according to an embodiment of the present invention;
FIG. 10 is a schematic view of a bendable catheter sheath according to an embodiment of the present invention;
FIG. 11 is a schematic view of a dilator according to an embodiment of the present invention;
FIG. 12 is a schematic view of a loader according to an embodiment of the invention;
FIG. 13a is a schematic view showing the overall structure of a conveying pipe according to an embodiment of the present invention;
FIG. 13b is an enlarged schematic view of an extension arm on a delivery tube according to one embodiment of the present invention;
FIG. 13c is a schematic view illustrating a state of penetrating a pushing rod in a conveying pipe according to an embodiment of the present invention;
FIG. 14 is a schematic view of a push rod according to an embodiment of the present invention;
FIG. 15 is a schematic view of an assembly of an adjustable bend catheter sheath, dilator and guidewire;
FIG. 16 is a schematic illustration of the assembly of an adjustable bend catheter sheath, delivery tube, and push rod;
the bending illustrations of the structures in fig. 10-16 are merely meant to illustrate their flexible nature;
In the figure:
20. a base; 201. a butt joint part; 202. a clamping block; 203. an internal thread;
30. A slide block; 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. a bending section;
80. A dilator;
90. a guide wire;
100. A loader;
110. A delivery tube; 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 should 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", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present invention, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In one embodiment of the present invention, a compressible valve clamping system includes a valve clamp, an adjustable curved catheter sheath, a dilator 80, a loader 100, a delivery tube 110, and a push rod 120; wherein,
As shown in fig. 3a to 3c, the valve clamp comprises a base 20, a sliding block 30 and a clamping component, wherein the surfaces of the base 20, the sliding block 30 and the clamping component are coated with a polymer film or a polymer material, and in the embodiment, the surfaces of the base 20, the sliding block 30 and the clamping component are coated with a PET film to promote endothelialization of the valve clamp after being implanted into a human body;
As shown in fig. 4a and 4b, the proximal end side of the base 20 is provided with a docking portion 201, preferably, the docking portion 201 is disposed at a central position of the proximal end side of the base 20, the docking portion 20 has at least a first docking structure and a second docking structure, the first docking structure is connected with the distal end of the slider 30, the second docking structure is connected with the distal end of the push rod 120, in this embodiment, for simplicity of illustration, the first docking structure is a fixture block 202 disposed on the circumferential side of the docking portion 201, and the second docking structure is an internal thread 203 disposed on the inner side of the docking portion 201.
As shown in fig. 5a-5c, the center of the slider 30 is axially provided with a center hole 301 penetrating the slider 30, the center hole 301 is used for the pushing rod 120 to pass through, and the slider 30 can move in the axial direction to approach and separate from the base 20, so that two folding states exist for the clamping component by means of the movement of the slider 30, the slider 30 is in a first folding state when being close to the base 20 to the greatest extent, and is in a second folding state when being far away from the base 20 to the greatest extent, the first folding state is used for further clamping after the valve clamp captures valve tissue, and the outer diameter of the valve clamp in the second folding state is smaller, so that the valve clamp is more beneficial to conveying in the conveying pipe 110. The slider 30 includes a first connecting portion 302 disposed at a distal end, a second connecting portion 304 disposed at a proximal end, and a middle portion 303 disposed between the first connecting portion 302 and the second connecting portion 304, where the first connecting portion 302 is configured to connect with a first docking structure in the docking portion 201, and therefore, the first connecting portion 302 has a first connecting structure adapted to the first docking structure, and in this embodiment, the first docking structure is configured as the fixture block 202, and therefore, the first connecting structure is a clamping groove disposed inside the distal end of the first connecting portion 302. The second connecting portion 304 has a second connecting structure for detachably connecting with the distal end of the delivery tube 110, and in this embodiment, the second connecting structure is a protrusion 305 provided on the circumferential side of the second connecting portion 304 for simplicity of description. When the proximal end thickness of the middle portion 303 is greater than the distal end thickness thereof and the slider 30 is pushed toward the base 20 to fold the first clamping arm 402 and the second clamping arm 403, a certain included angle still exists between the second clamping arm 403 and the slider 30, and the thicker proximal end of the slider 30 can compensate for the gap of the included angle at the position, so that a supporting force is provided for the second clamping arm 403, and the clamping force between the two clamping arms is improved. The middle part 303 is also provided with a lantern ring wrapping the middle part 303, the lantern ring is woven by elastic materials, and when in conveying, the lantern ring is compressed and limited in pipe diameter for conveying, after conveying in place, the limiting force is removed, and the lantern ring can restore to the shaping shape by itself;
The clamping component is woven by elastic materials, and can be integrally woven, for example, a frame of the clamping component is woven by thick nickel titanium wires, and then thin nickel titanium wires are woven into the frame. At least two sets of clamping members are provided, and two sets are taken as examples in the embodiment. Each group of clamping components comprises a connecting arm 401, a first clamping arm 402 and a second clamping arm 403, wherein the distal end of the connecting arm 401 is movably connected with the base 20, the proximal end of the connecting arm 401 is movably connected with one end of the first clamping arm 402 to form a first included angle, the first included angle is provided with a shaping angle a1, preferably, 0 degrees is less than or equal to a1 and less than or equal to 15 degrees, the other end of the first clamping arm 402 is movably connected to the sliding block 30, one end of the second clamping arm 403 is connected with the other end of the first clamping arm 402 to form a second included angle, the shaping angle a2 is also arranged at the second included angle, preferably, 0 degrees is less than or equal to 15 degrees, and one side of the second clamping arm 403, facing the first clamping arm 402, is provided with clamping teeth 404. Briefly, the connecting arm 401, the first clamping arm 402 and the second clamping arm 403 constitute a "z" clamp. As shown in fig. 6c-7b, the movable connection structure between the distal end of the connecting arm 401 and the base 20, between the proximal end of the connecting arm 401 and the first clamping arm 402, and between the first clamping arm 402 and the slider 30 may be configured as a rotating shaft structure, for example, a support frame perpendicular to the base 20 is disposed on the proximal end side of the base 20, a transverse shaft 601 parallel to the proximal end side of the base 20 is disposed on the support frame, a shaft hole 602 is disposed on the inner side of an opposite groove on the distal end of the connecting arm 401, two ends of the transverse shaft 601 are disposed in the shaft hole 602 in a penetrating manner, and by means of the rotation of the transverse shaft 601 in the shaft hole 602, the movable connection between the connecting arm 401 and the base 20 can be achieved. Of course, this is just a relatively easy-to-understand manner of movable connection, and in addition, since the clamping component and the collar on the slider 30 can be both woven, the nickel-titanium wire at the other end of the first clamping arm 402 is tied to the collar, and the two can also implement movable connection similar to the rotation shaft, which is not illustrated herein;
the pull wires 50 are inserted into the other ends of the second clamping arms 403, and the two pull wires 50 respectively inserted into the two second clamping arms 403 extend from the conveying pipe 110 to the outside of the body, and the pull wires 50 are pulled or loosened by the outside of the body, so as to adjust the size of the second included angle a 2. As shown in fig. 6a-6c, the connecting arm 401 is a groove structure, and the width of the groove is larger than the width of each of the first clamping arm 402 and the second clamping arm 403, so that when the slider 30 is pushed toward the base 20 to fold the first clamping arm 402 and the second clamping arm 403, the groove can provide an accommodating space for the first clamping arm 402 and at least a part of the second clamping arm 403, thereby enhancing the firmness and stability of the clamping of the valve clamp. In addition, it is also possible to define a proximal arm width of the connecting arm 401 that is narrower than its distal arm width, the transition from the proximal narrow to the distal wide, facilitating the gradual retraction of the valve clip into the delivery tube 110 from proximal to distal, and in short, the connecting arm 401 is a groove structure having a "U" shaped profile;
the proximal ends of the adjustable bend catheter sheath, dilator 80, loader 100, and delivery tube 110 are each provided with a hemostatic valve 130, wherein,
As shown in fig. 10, the bendable catheter sheath further comprises a proximal straight tube section 701 and a distal bending section 702, and the straight tube section 701 and the bending section 702 have a continuous first through hole communicating two ends. The bending section 702 is a bendable catheter section, which is made of elastic material, and the bending principle is that: the bending of the bending section 702 is adjusted by tightening or loosening the traction wire, and for example, reference may be made to an adjustable bending sheath tube with a patent number 201310397312.6 and a delivery system having the same, because the bending structure and operation of the adjustable bending catheter sheath are already known in the art, and the invention is not described in more detail. The invention adopts the adjustable curved catheter sheath as the conveying device of the valve clamp, because the valve clamp is conveyed from the right atrium to the left atrium, the conveying direction of the valve clamp is inconsistent with the position of the mitral valve, and the output direction of the valve clamp is required to be adjusted to the position of the mitral valve through the adjustment of the curved section 702;
as shown in fig. 11, the dilator 80 is adapted to pass through the first throughbore, the axial length of the dilator 80 is greater than the axial length of the adjustable bend catheter sheath, and the dilator 80 has a second throughbore communicating the two ends, the inner diameter of the second throughbore being adapted to pass through the guidewire 90;
as shown in fig. 12, the loader 100 has a third through hole communicating the two ends, the third through hole is adapted to accommodate the valve clamp and at least a portion of the delivery tube 110, and at least a portion of the third through hole has an outer wall sized to enter the first through hole, and the loader 100 is merely a transit structure for the valve clamp;
As shown in fig. 13a, the conveying pipe 110 is suitable for passing through the third through hole and the first through hole, the conveying pipe 110 is also provided with an elastic section, the axial length of the conveying pipe 110 is larger than the total axial length of the adjustable catheter sheath and the loader 100, the conveying pipe 110 is provided with a fourth through hole communicated with two ends, the distal end of the conveying pipe 110 and the second connecting structure are detachably connected, whereas in the embodiment, the second connecting structure is provided with a protrusion 305, therefore, the distal end of the conveying pipe 110 needs to be provided with a connecting structure matched with the protrusion 305, in order to achieve the purpose, in the embodiment, as shown in fig. 13b and 13c, the distal end of the conveying pipe 110 is provided with at least two extension arms 1101, the extension arms 1101 are provided with clamping holes 1104, the clamping holes 1104 correspond to the protrusions 305 in number and positions, and the clamping holes 1104 are ensured to be suitable for clamping the protrusions 305, so that the connection between the conveying pipe 110 and the sliding blocks 30 is achieved. Meanwhile, considering that the connection relationship between the conveying pipe 110 and the sliding block 30 needs to be relieved after the sliding block 30 is conveyed in place, under the premise of the structure, the extension arm 1101 is made of elastic materials, the elastic materials comprise nickel-titanium alloy, spring steel and the like, the extension arm 1101 is shaped into a flaring structure, at least two clamping pieces 1102 are arranged at the near end of the inner side of the extension arm 1101, the two clamping pieces 1102 are arranged on the inner side walls of the opposite sides of the extension arm 1101 in a staggered mode, corresponding pore passages 1103 are arranged on the two clamping pieces 1102, the pore passages 1103 are used for enabling the push rod 120 to penetrate through, therefore, the extension arm 1101 is connected with the push rod 120 by the clamping pieces 1102, the two extension arms 1101 are kept at a certain distance, the fact that the protrusions 305 can be stably clamped in the clamping holes 1104 is ensured, when the connection relationship between the conveying pipe 110 and the sliding block 30 needs to be removed, the push rod 120 is withdrawn from the clamping holes 1103, the connection relationship between the push rod 120 and the conveying pipe 110 is removed, and the extension arm 1101 is restored to the shape, and the protrusions 305 are enabled to be separated from the clamping holes 1103, and the detachment work is realized;
As shown in fig. 14, the pushing rod 120 also has an elastic section, the axial length of the pushing rod 120 is greater than that of the conveying pipe 110, and is suitable for axial movement along the fourth through hole, and the outer diameter of the pushing rod 120 is smaller than the inner diameter of the central hole 301, so that the pushing rod 120 can be inserted into the central hole 301, the distal end of the pushing rod 120 has a fourth connection structure, and the pushing rod 120 is detachably connected with the second docking structure of the docking portion 201 through the fourth connection structure.
According to the valve clasper system of the present embodiment, the following embodiments can be obtained:
1) Assembly of push rod 120, delivery tube 110 and loader 100: inserting the push rod 120 from the distal end of the push rod 120 into the fourth through hole from the proximal end of the delivery tube 110, and inserting the delivery tube 110 from the proximal end of the loader 100 into the third through hole from the distal end of the delivery tube 110;
2) Assembly between slide 30 and delivery tube 110: as shown in fig. 8a and 8b, after the positions of the clamping holes 1104 on the extension arm 1101 of the conveying pipe 110 and the protrusions 305 on the sliding block 30 are corresponding, a push rod 120 is inserted into the fourth through hole of the conveying pipe 110, and the push rod 120 is ensured to simultaneously pass through the hole 1103 of the clamping piece 1102, and the extension arm 1101 in the flaring state is subjected to necking limitation, so that the protrusions 305 are just clamped into the clamping holes 1104;
3) Assembly between base 20 and push rod 120: as shown in fig. 8a and 8b, the pushing rod 120 is pushed along the axial direction of the conveying pipe 110 until the external thread on the pushing rod 120 is completely screwed into the internal thread 203 of the abutting portion 201 of the base 20;
4) Introducing an adjustable curved catheter sheath into the left atrium: as shown in fig. 15, the distal end of the guide wire 90 is first led into the body by using a puncture tool such as a puncture needle, the distal end of the guide wire 90 is continuously led into the left atrium, the puncture needle is then removed, the dilator 80 is penetrated in the first through hole of the adjustable curved catheter sheath, the proximal end of the guide wire 90 is penetrated from the distal end of the dilator 80 through the second through hole, so that the dilator 80 can redirect the adjustable curved catheter sheath into the left atrium under the guidance of the guide wire 90 (the distal end of the adjustable curved catheter sheath is a curved section, the material is softer, the hardness is low, the femoral vein cannot be directly penetrated, and the dilator 80 with a tapered head and higher hardness is required to guide the femoral vein, which is a medical routine operation), and then the distal end of the guide wire 90 is pulled into the dilator 80, and the guide wire 90 and the dilator 80 are withdrawn from the adjustable curved catheter sheath;
5) Folding operation of the clamping component: the clamping component has two furled states, as shown in fig. 9a, the sliding block 30 is in a first furled state when being furled to the base 20 to the greatest extent, and is in a second furled state when being away from the base 20 to the greatest extent, as shown in fig. 9b, the two furled states can be used for conveying, but in consideration of the fact that the outer diameter of the valve clamp in the second furled state is smaller, the conveying of the valve clamp in the conveying pipe 110 is facilitated, so the second furled state is adopted for conveying the clamp in the embodiment;
6) Transfer operation of loader: as shown in fig. 16, the valve clamp in the collapsed state is completely retracted into the loader 100, and then the distal end of the loader 100 is inserted into the first through hole of the adjustable curved catheter sheath, and the valve clamp is pushed into the first through hole of the adjustable curved catheter sheath by the loader 100 (the reason that the valve clamp is not directly pushed into the adjustable curved catheter sheath is that it is inconvenient to directly send the valve clamp into the adjustable curved catheter sheath from the proximal end because the hemostatic valve 130 and other components are provided at the proximal end of the adjustable curved catheter sheath);
7) Delivering the valve clamp to the mitral valve and capturing valve tissue: pushing the valve clamp into the left atrium along the adjustable curved catheter sheath, operating the curved section 702 of the adjustable curved catheter sheath to curve toward the mitral valve position, bending the delivery tube 110 and the pushing rod 120 along with the curved section, continuing to push until the clamping component is completely separated from the adjustable curved catheter sheath and returns to the shaping state from the folded state, then tightening the pull wire 50 penetrating through the second clamping arm 403 again, ensuring that the base 20, the connecting arm 401 and the first clamping arm 402 enter the left atrium, and simultaneously enabling at least a part of the second clamping arm 403 to be positioned in the left atrium, at the same time, loosening the pull wire 50 (the two pull wires 50 penetrating through the two second clamping arms 403 can be independently tightened or loosened, or simultaneously tightened or loosened), capturing valve tissue by the clamping teeth 404, and preventing the captured valve tissue from slipping out from the space between the clamping arms;
8) Further clamping of the captured valve tissue: the valve clamp is in a first furling state, specifically, the push rod 120 is kept at the current position unchanged, so that the base 20 connected with the push rod 120 is still, the conveying pipe 110 is continuously pushed, the sliding block 30 is gradually close to the base 20 under the pushing force of the conveying pipe 110, and finally, the connection between the sliding block 30 and the base 20 is realized through the clamping groove and the clamping block 202, at the moment, the clamping component is in the first furling state, so that the second included angle a2 between the first clamping arm 402 and the second clamping arm 403 is greatly reduced, the clamping force on valve tissues is greatly increased, and the clamping state at the moment is just in compliance with the shaping form because the shaping angle of the first included angle and the second included angle is set to be close to 0 degrees, and the current clamping state can be well maintained;
9) Releasing the connection state between the push rod 120 and the base 20, and between the delivery pipe 110 and the slider 30: the pushing rod 120 is reversely rotated, the external thread of the pushing rod 120 is screwed out of the internal thread 203 of the abutting part 201 and then is withdrawn from the conveying pipe 110, meanwhile, the extending arm 1101 immediately restores the flaring structure along with the withdrawal of the acting force of the extending arm 1101, the connection between the conveying pipe 110 and the sliding block 30 is released, the conveying pipe 110 and the pushing rod 120 are withdrawn from the adjustable bending catheter sheath together, and finally the adjustable bending catheter sheath is withdrawn.
It should be noted that the order of the operational steps described above is not unique, as long as it is feasible according to industry operational standards or common sense.
The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention by one of ordinary skill in the art without undue burden. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.