Mechanical expansion device

Abstract

The utility model provides a mechanical expansion device which comprises a head part, a guide wire cavity and a handle which are sequentially connected, the outer side of the guide wire cavity is sleeved with a pushing pipe capable of being controlled by the handle to slide, an expansion part is arranged between the head part and the pushing pipe, the first end of the pushing pipe is connected with the end of the expansion part, and the second end of the pushing pipe is connected with the end of the expansion part. The second end of the pushing tube is connected with a sliding piece in the handle, and the expansion and contraction of the expansion part are realized through the sliding of the pushing tube on the guide wire cavity. The embodiment of the utility model has the characteristic that the blood flow is not blocked in the dilation process, so that the positioning is simple due to no impact of double flow, the dilation degree and the dilation position can be accurately controlled due to no need of liquid compression and simple requirements on operation time, and in addition, different specifications can be set according to requirements, so that the operation is convenient. The problem that the expansion pressure is insufficient or time is prolonged does not exist, and meanwhile the problem that large-diameter size setting of a non-compliant balloon cannot be achieved is solved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and in particular to a mechanical expansion device. Background Art

[0002] As the population ages, the prevalence of heart disease continues to rise. Valvular disease is a disease with a high incidence in patients with heart disease, including congenital diseases and senile lesions. Senile lesions, for example, refer to valvular annular thickening, insufficiency or calcification.

[0003] An artificial heart valve is an implantable medical device used to treat heart valve disease or heart defects. By replacing the diseased valve in the human heart, the patient can restore the blood circulation function. Heart valve replacement here is a surgery that uses an artificial mechanical valve made of synthetic materials or an artificial biological valve made of biological tissue to replace the valve, which is referred to as valve replacement.

[0004] Among heart valve replacement surgeries, TAVR, or transcatheter aortic valve implantation, is a minimally invasive form of surgery that involves inserting an assembled aortic valve into the aortic root of a patient via a catheter. With the enrichment of clinical experience, the development of instruments, and the continuous improvement of technology, TAVR technology in China has become increasingly mature, with advantages such as no need for thoracotomy, less trauma, shorter operation time, and faster recovery.

[0005] During transcatheter aortic valve implantation, a biological valve or polymer valve needs to be implanted in the place of the original valve. Since the artificial valve is implanted in the place of the original valve, the original valve opening is not large enough to accommodate the new valve, because the new valve itself needs to occupy a certain space. Implanting the artificial valve directly in the place of the original valve will cause the new valve opening to be too small, resulting in insufficient blood flow.

[0006] In order to solve the problem that the valve opening is not large enough to place the new valve, a high-pressure balloon is currently used clinically to expand the original valve ring so that the valve ring can accommodate the new artificial valve. The existing technology uses a valve balloon to push the high pressure produced by the contrast agent through a balloon pump. Under high pressure, the front end of the valve balloon expands first, and then drags back to the valve ring to further expand the valve balloon. After the replacement valve balloon is fully expanded, it drives the valve ring to expand.

[0007] The existing technology uses valve balloons, for example, to expand the valve ring. Completely blocking blood flow with the balloon brings a series of problems. Because balloon expansion will cause complete blockage of blood flow, the expansion time needs to be as short as possible, otherwise the heart function will be damaged and intracranial ischemia will cause brain damage due to blood flow blockage; the balloon blocking blood flow process will be strongly impacted by the blood flow, and the small position of the valve ring makes it difficult to position the balloon; the positioning difficulty is too great and the expansion difficulty determines that the expansion time is difficult to control. These contradictory conditions limit the rapid promotion of TAVR surgery. At the same time, the valve balloon is required to achieve distributed expansion, the structural strength is easily affected, and there is a risk of rupture. Once the balloon ruptures under high pressure, it will cause an unbearable impact on the heart and the ascending aorta. It is precisely because of the above-mentioned difficulty in positioning, the complete blockage of blood flow, the rapid and complete expansion, the insufficient expansion of the valve ring or the need for multiple expansions, and the high technical requirements for the operator. In addition, the balloon has a risk of rupture. Once the balloon ruptures under high pressure, it will cause an unbearable impact on the heart and the ascending aorta. The larger the balloon, the less pressure it can withstand and the longer it takes to inflate the balloon, thus limiting the size of the balloon expansion.

[0008] When performing expansion operations using non-compliant balloons, existing non-compliant balloons have the problem of being unable to achieve large diameter size settings. In addition, since the non-compliant balloon will deform when obstructed, the balloon will move to areas with low pressure, so there is no way to control the expansion length, which results in insufficient expansion force of the non-compliant balloon (that is, the bursting pressure of the non-compliant balloon is low), thereby failing to block blood flow well, and the degree of expansion cannot be controlled, and the expansion position cannot be accurately controlled. Utility Model Content

[0009] In view of this, the utility model aims to provide a mechanical expansion device to solve the technical problems of the prior art.

[0010] On the one hand, the utility model provides a mechanical expansion device, including a head, a guide wire cavity and a handle connected in sequence, a push tube which can be controlled to slide by the handle is sleeved on the outer side of the guide wire cavity, an expansion part is arranged between the head and the push tube, a first end of the push tube is connected to an end of the expansion part, and a second end of the push tube is connected to a sliding member in the handle, and the expansion part is expanded and contracted by sliding the push tube on the guide wire cavity.

[0011] In some embodiments, the expansion portion adopts a basket structure, and the basket structure is formed by adopting a metal woven mesh tube structure, and the mesh tube structure is formed based on a single metal wire forming a spiral structure.

[0012] In some embodiments, the expansion portion adopts the structure of an expansion frame, and the expansion frame includes a first end, a second end, a third end and a fourth end which are arranged on the guide wire cavity and in sequence along the extension direction of the guide wire cavity, the first end is fixedly connected to the distal position of the guide wire cavity, the third end is arranged on the guide wire cavity and its position relative to the first end remains unchanged, the fourth end is connected to the first end of the push tube, and the second end moves on the guide wire cavity. When the push tube moves relative to the head, the push tube drives the fourth end to move, and at the same time drives the second end to move.

[0013] In some embodiments, the expansion frame further includes a plurality of connecting rod portions. When the fourth end moves toward the direction approaching the first end, the expansion frame can form a lantern-shaped structure after being unfolded through the plurality of connecting rod portions. When the fourth end moves toward the direction away from the first end, the plurality of connecting rod portions of the expansion frame shrink and fit into the guide wire cavity.

[0014] In some embodiments, the connecting rod portion includes a first connecting rod, a cross beam and a second connecting rod connected in sequence, wherein the first end of the first connecting rod is connected to the first end head, the second end of the first connecting rod is connected to the first end of the cross beam, the second end of the cross beam is connected to the first end of the second connecting rod, the second end of the second connecting rod is connected to the fourth end head, the second end head is connected to the first end of the cross beam through a third connecting rod, and the third end head is connected to the second end of the cross beam in the connecting rod portion through a fourth connecting rod.

[0015] In some embodiments, a linkage rod is disposed between the second end and the fourth end, and the third end is fixed to the guide wire cavity or connected to the first end via a linkage rod.

[0016] In some embodiments, connecting parts are respectively provided at the first end and the second end of the beam, and each of the connecting parts includes a first connecting hole and a second connecting hole, the first connecting hole is arranged near the end of the beam relative to the second connecting hole, the first connecting hole at the first end of the beam is used to connect with the first connecting rod, the second connecting hole at the first end of the beam is used to connect with the third connecting rod, the first connecting hole at the second end of the beam is used to connect with the second connecting rod, and the second connecting hole at the second end of the beam is used to connect with the fourth connecting rod.

[0017] In some embodiments, the first connecting hole and the second connecting hole adopt a single-hole or double-hole structure.

[0018] In some embodiments, a third connecting hole and a fourth connecting hole are respectively provided at two ends of the first connecting rod, the third connecting hole is used to connect with the first end head, and the fourth connecting hole is used to connect with the first end of the beam, and the third connecting hole and the fourth connecting hole adopt a single-hole or double-hole structure.

[0019] In some embodiments, the first terminal includes a main body and a plurality of connecting terminals, and the connecting terminals are provided with a terminal support groove, and the terminal support groove and the third connecting hole form a slot coaxial structure.

[0020] In some embodiments, a linkage rod connection hole is provided on the main body, and the linkage rod connection hole is arranged on the wall surface of the main body or on a protrusion on the wall surface of the main body.

[0021] In some embodiments, a terminal connection hole is provided on the connecting terminal of the first terminal.

[0022] In some embodiments, the handle includes a fixed part and a rotating part, the first part of the rotating part is accommodated in the fixed part and is rotatably connected to the fixed part, the second part of the rotating part is located on the outside of the fixed part, and the outer wall of the first part of the rotating part is sleeved with the inner wall of the fixed part; the push tube is arranged on the outside of the fixed part and penetrates into the fixed part from the distal end of the fixed part, the guide wire cavity penetrates from the proximal end of the handle and exits from the distal end of the handle, and a connector is arranged at the end of the guide wire cavity for flushing the guide wire cavity.

[0023] In some embodiments, a front end sliding member is disposed in the rotating part, and the front end sliding member is connected to the proximal end of the pushing tube. A first internal thread is disposed on the inner wall of the front end of the rotating part, and the front end sliding member is engaged with the first internal thread. A guide rail is disposed in the fixed part, and the guide rail is fixed in the fixed part by a guide rail lock. The guide rail passes through the front end sliding member to provide a guiding function for the movement of the front end sliding member.

[0024] In some embodiments, a front end sliding member and a rear end sliding member are arranged in the rotating part, the front end sliding member is connected to the proximal end of the pushing tube, a first internal thread is arranged on the inner wall of the front end of the rotating part, and a second internal thread is arranged on the inner wall of the rear end of the rotating part, and the front end sliding member and the rear end sliding member are respectively engaged with the first internal thread and the second internal thread.

[0025] The embodiment of the utility model has the characteristic of not blocking blood flow during the expansion process, so that positioning becomes simple because it will not be affected by the double-flow impact. Since there is no need to compress the liquid and the operation time requirement is simple, the expansion degree and expansion position can be accurately controlled. In addition, different specifications can be set according to needs, and there is no problem of insufficient expansion pressure or prolonged time. At the same time, the problem that non-compliant balloons cannot be set to large diameter sizes is solved.

[0026] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In the drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar parts. The drawings generally illustrate various embodiments by way of example and not limitation, and together with the specification and claims, are used to illustrate the disclosed embodiments. When appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present apparatus or method. The drawings described herein are used to provide a further understanding of the present invention and constitute a part of this application. The illustrative embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0028] Figure 1 It is a structural schematic diagram of the mechanical expansion device provided by the utility model;

[0029] Figure 2 It is a structural schematic diagram of the expansion part of the mechanical expansion device provided by the utility model in a contracted state;

[0030] Figure 3 It is a structural schematic diagram of the expansion part of the mechanical expansion device provided by the utility model in an expanded state;

[0031] Figure 4 It is a structural schematic diagram of the expansion frame in the mechanical expansion device provided by the utility model in the expanded state;

[0032] Figure 5 It is a structural schematic diagram of another angle in which the expansion frame of the mechanical expansion device provided by the utility model is in an expanded state;

[0033] Figure 6 It is a structural schematic diagram of a crossbeam in an expansion frame in a mechanical expansion device provided by the utility model;

[0034] Figure 7It is another structural schematic diagram of the crossbeam in the expansion frame of the mechanical expansion device provided by the utility model;

[0035] Figure 8 It is a structural schematic diagram of a connecting rod in an expansion frame in a mechanical expansion device provided by the utility model;

[0036] Fig. 9 It is another structural schematic diagram of the connecting rod in the expansion frame of the mechanical expansion device provided by the utility model;

[0037] Fig.10 It is another structural schematic diagram of the connecting rod in the expansion frame of the mechanical expansion device provided by the utility model;

[0038] Fig.11 It is a structural schematic diagram of the end of the expansion frame in the mechanical expansion device provided by the utility model;

[0039] Fig.12 It is a schematic projection diagram of the end of the expansion frame in the mechanical expansion device provided by the utility model;

[0040] Fig.13 It is another structural schematic diagram of the end of the expansion frame in the mechanical expansion device provided by the utility model;

[0041] Fig.14 It is another structural schematic diagram of the end of the expansion frame in the mechanical expansion device provided by the utility model;

[0042] Fig.15 It is a structural schematic diagram of a linkage rod in an expansion frame in a mechanical expansion device provided by the utility model;

[0043] Fig.16 It is a structural schematic diagram of another expansion frame in the mechanical expansion device provided by the utility model in an expanded state;

[0044] Fig.17 It is a structural schematic diagram of another expansion frame in the mechanical expansion device provided by the utility model in another angle in the expanded state;

[0045] Fig.18 It is a structural schematic diagram of another expansion frame in the mechanical expansion device provided by the utility model in a contracted state;

[0046] Fig.19 It is a structural schematic diagram of another expansion frame in the mechanical expansion device provided by the utility model in an expanded state;

[0047] Fig. 20 It is a structural schematic diagram of another expansion frame in the mechanical expansion device provided by the utility model in a contracted state;

[0048] Fig.21 It is a structural schematic diagram of another expansion frame in the mechanical expansion device provided by the utility model in an expanded state;

[0049] Fig. 22 It is a structural schematic diagram of another expansion frame in the mechanical expansion device provided by the utility model in another angle in the expanded state;

[0050] Fig.23 It is a structural schematic diagram of another expansion frame in the mechanical expansion device provided by the utility model in a contracted state;

[0051] Fig.24 It is a structural schematic diagram of a basket structure as an expansion part in a mechanical expansion device provided by the utility model in a natural state;

[0052] Fig.25 It is a structural schematic diagram of a basket structure as an expansion part in the mechanical expansion device provided by the utility model in an axially compressed state;

[0053] Fig.26 It is a structural schematic diagram of a handle in the mechanical expansion device provided by the utility model;

[0054] Fig. 27 It is a structural schematic diagram of a handle in the mechanical expansion device provided by the utility model.

[0055] The above drawings include the following reference numerals:

[0056] 1-expansion part; 2-head; 3-guidewire cavity; 4-push tube; 5-handle; 101a-first terminal; 101a1-main body; 101a2-connecting terminal; 101a3-terminal support groove; 101a4-link rod connecting hole; 101a5-terminal connecting hole; 101b-second terminal; 101c-third terminal; 101d-fourth terminal; 102-crossbeam; 102a-first connecting hole; 102b-second connecting hole ;103a-first connecting rod;103a1-third connecting hole;103a2-fourth connecting hole;103b-second connecting rod;103c-third connecting rod;103d-fourth connecting rod;104-linking rod;501-fixed part;502-rotating part;503 joint;504-guide rail lock;505-guide rail;506A-front end sliding piece;506B-rear end sliding piece;508A-first internal thread;508B-second internal thread. DETAILED DESCRIPTION

[0057] The specific embodiments of the present invention are described in detail below with reference to the accompanying drawings, but are not intended to limit the present invention.

[0058] It should be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be considered as limiting, but only as an example of an embodiment. Other modifications within the scope and spirit of the utility model will occur to those skilled in the art.

[0059] The accompanying drawings, which are included in and constitute a part of the specification, illustrate embodiments of the present invention and, together with the general description of the present invention given above and the detailed description of the embodiments given below, are used to explain the principles of the present invention.

[0060] These and other characteristics of the invention will become apparent from the following description of a preferred form of embodiment given as a non-limiting example, with reference to the accompanying drawings.

[0061] It should also be understood that although the present invention has been described with reference to some specific examples, those skilled in the art will be able to realize many other equivalent forms of the present invention that have the features described in the claims and are therefore within the scope of protection defined thereby.

[0062] The above and other aspects, features and advantages of the present invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

[0063] Specific embodiments of the present invention are described hereinafter with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely examples of the present invention, which may be implemented in a variety of ways. Well-known and / or repeated functions and structures are not described in detail to avoid unnecessary or redundant details that obscure the present invention. Therefore, the specific structural and functional details disclosed herein are not intended to be limiting, but merely serve as the basis and representative basis for the claims to teach those skilled in the art to use the present invention in a variety of ways with substantially any suitable detailed structure.

[0064] It should be noted that the terms "first", "second", etc. in the specification and claims of the utility model and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so that the embodiments of the utility model described here can be implemented in an order other than those illustrated or described here. In addition, the terms "including" and "having" and any of their variations are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0065] This specification may use the phrases "in one embodiment", "in another embodiment", "in yet another embodiment" or "in other embodiments", all of which may refer to one or more of the same or different embodiments according to the present invention.

[0066] The embodiment of the utility model provides a mechanical expansion device, which is suitable for expanding the valve ring in transcatheter aortic valve implantation surgery, and can also be used for re-expansion in aortic stents, expansion of aortic stenosis, etc. Figure 1-Figure 3 As shown, the mechanical expansion device includes a conical head 2, a guidewire cavity 3 and a handle 5, wherein the first end of the guidewire cavity 3 is connected to the head 2, and the second end of the guidewire cavity 3 is connected to the end of the handle 5. The head 2 here is used to provide a transitional head end portion, and the head 2 is set in a conical shape to facilitate the introduction of the mechanical expansion device into the human body and prevent the mechanical expansion device from damaging the blood vessel wall and the heart. The guidewire cavity 3 here is used to provide a guidewire channel, through which the mechanical expansion device can be delivered to the target position in the human body along the guidewire.

[0067] Furthermore, a push tube 4 is sleeved on the outside of the guide wire cavity 3 , and the push tube 4 can slide on the outside of the guide wire cavity 3 . The sliding of the push tube 4 here can be achieved by controlling the handle 5 .

[0068] Furthermore, an expansion part 1 is provided between the head 2 and the push tube 4, and the guidewire cavity 3 here can provide fixed support for the expansion part 1. In this way, the expansion part 1 can be expanded and contracted by sliding the push tube 4 on the guidewire cavity 3. Specifically, the push tube 4 can be controlled to slide by operating the handle 5, so that the expansion part 1 can be expanded and contracted smoothly and quickly, and finally the expansion operation can be realized in the human body.

[0069] Furthermore, since the push tube 4 is sleeved on the guide wire cavity 3, the first end of the push tube 4 is connected to the end of the expansion part 1, and the second end of the push tube 4 is connected to the sliding member in the handle 5. In this way, the end of the expansion frame 1 is connected to the sliding member in the handle 5 by the push tube 4, so that the unidirectional movement of the push tube 4 or the relative movement of the push tube 4 and the guide wire cavity 3 can be controlled by operating the sliding member in the handle 5, thereby realizing the operation control of the expansion part 1 to expand or contract.

[0070] In one embodiment, if Figure 24-25As shown, the expansion portion 1 can be a basket structure, wherein the basket structure is formed by adopting a metal woven mesh tube structure, wherein the mesh tube structure is formed based on a single metal wire to form a spiral structure, and when the basket structure is stretched, the metal wires in the mesh tube structure can be close to a straight state, so that the mesh tube structure can be contracted to a very small state, so that a thinner sheath can be delivered through a distal vascular access, thereby achieving minimally invasive intervention.

[0071] When the mesh tube structure formed by the metal wire is squeezed axially, the spiral metal wire can be squeezed into a shape close to a tightly wound spring, so that the entire mesh tube structure forms a tube with a tight circumference constrained at both ends. Furthermore, after the mesh tube structure woven by the metal wire is squeezed axially to form an outward squeezing force in the radial direction, it can achieve expansion of the valve ring, for example. At the same time, since the interior of the mesh tube structure is hollow, it is convenient for blood to flow smoothly in the frame, thereby avoiding the problem of blood flow blockage caused by expansion.

[0072] In another embodiment, the expansion portion 1 may also adopt an expansion frame structure. The expansion frame 1 can better achieve expansion and contraction compared to the basket structure. The structure of the expansion frame is described in detail below.

[0073] like Figure 4 and Figure 5 As shown, the expansion frame in this embodiment is a skeleton structure based on a connecting rod, so that the expansion frame can be easily expanded or contracted. Specifically, the expansion frame includes a first terminal 101a, a second terminal 101b, a third terminal 101c and a fourth terminal 101d arranged on the guidewire cavity 3 and arranged in sequence along the extension direction of the guidewire cavity 3, wherein the first terminal 101a is fixedly connected to the distal position of the guidewire cavity 3 and is located on the proximal side of the head 2, the third terminal 101c is arranged on the guidewire cavity 3 and remains unchanged relative to the first terminal 101a, the fourth terminal 101d is connected to the first end of the push tube 4, and the second terminal 101b can move on the guidewire cavity 3.

[0074] In this way, when the push tube 4 moves relative to the head 2, the expansion frame can be expanded or contracted. To this end, the push tube 4 drives the fourth end 101d to move, and at the same time drives the second end 101b to move, that is, the second end 101b and the fourth end 101d both move relative to the first end 101a.

[0075] Furthermore, in order to realize linkage between the second end 101b and the fourth end 101d relative to the first end 101a, the expansion frame also includes a plurality of connecting rods. Specifically, when the fourth end 101d moves toward the direction close to the first end 101a, the expansion frame can form a lantern-shaped structure through the plurality of connecting rods after being deployed, so as to realize expansion of the valve ring when the expansion frame 1 is deployed. When the fourth end 101d moves away from the first end 101a, the plurality of connecting rods of the expansion frame 1 can be contracted and fit the guidewire cavity 3, so that the mechanical expansion device can enter the human body.

[0076] The number of connecting rods in the expansion frame can be selected within the range of 3-20 to meet the expansion requirements of the valve ring. Preferably, the multiple connecting rods can be symmetrically arranged along the radial direction. In a specific embodiment, the radial diameter of the expansion frame 1 after expansion can reach 15-30 mm.

[0077] Specifically, each of the connecting rod portions includes a first connecting rod 103a, a cross beam 102 and a second connecting rod 103b connected in sequence, wherein the first end of the first connecting rod 103a is connected to the first end 101a, the second end of the first connecting rod 103a is connected to the first end of the cross beam 102, the second end of the cross beam 102 is connected to the first end of the second connecting rod 103b, and the second end of the second connecting rod 103b is connected to the fourth end 101d.

[0078] Furthermore, a hinged connection is adopted between the first end 101a and the first connecting rod 103a, between the first connecting rod 103a and the cross beam 102, between the cross beam 102 and the second connecting rod 103b, and between the second connecting rod 103b and the fourth end 101d, so that the first connecting rod 103a, the cross beam 102 and the second connecting rod 103b can rotate with each other to achieve the expansion or contraction of each connecting rod part.

[0079] In addition, the second end 101b is connected to the first end of the beam 102 through the third connecting rod 103c, and the third end 101c is connected to the second end of the beam 102 in the connecting rod portion through the fourth connecting rod 103d.

[0080] Furthermore, a linkage rod 104 is provided between the second end 101b and the fourth end 101d. The connection between the second end 101b and the fourth end 101d and the linkage rod 104 not only enables the movement of the second end 101b when the fourth end 101d moves, but also enables the expansion frame 1 to be more stable and adjust the degree of expansion of the expansion frame 1.

[0081] Here, the first end 101a is fixedly connected to the distal end of the guidewire cavity 3, and the third end 101c can be fixed to the guidewire cavity 3, and connected to the first end 101a through the linkage rod 104 so that the third end 101c can maintain a fixed position relative to the guidewire cavity 3. Figure 16-18 A structure using a linkage rod 104 is shown. Figure 2-Figure 5 The structure using two linkage rods 104 is shown. Here, the second end 101b and the fourth end 101d slide relatively on the guide wire cavity 3, and for this purpose, the spacing between the first end 101a and the fourth end 101d and between the second end 101b and the third end 101c is determined based on the degree of expansion of the link part, especially based on the relative rotation degree of the first link 103a, the second link 103b, the third link 103c, the fourth link 103d and the crossbeam 102. Preferably, the lengths of the first link 103a, the second link 103b, the third link 103c and the fourth link 103d can be the same, and the length of the crossbeam 102 here can be set within the range of 10-40mm.

[0082] In this way, when the first end 101a and the fourth end 101d move toward each other, the first connecting rod 103a and the second connecting rod 103b lift up the beam 102, and the linkage rod 104 makes the lifting and lowering amplitudes of the two ends of the beam 102 consistent, ensuring sufficient supporting force output to the outside and the stability of the structure during the output force process.

[0083] In order to realize the connection between the first connecting rod 103a and the second connecting rod 103b and the cross beam 102, and the connection between the third connecting rod 103c and the fourth connecting rod 103d and the cross beam 102, as shown in FIG. Figure 6 and Figure 7As shown, the first end and the second end of the crossbeam 102 are respectively provided with connecting parts, and the connecting parts can adopt a structure with connecting holes. Specifically, each of the connecting parts includes two groups of connecting holes, namely a first connecting hole 102a and a second connecting hole 102b. Here, the first connecting hole 102a is arranged near the end of the crossbeam 102 relative to the second connecting hole 102b. Here, the first connecting hole 102a and the second connecting hole 102b can be as shown in FIG. Figure 7 As shown, a single hole or Figure 6 The double-hole structure shown, wherein, in this embodiment, when the double-hole structure is adopted, the distances between the two holes in the first connecting hole 102a or the two holes in the second connecting hole 102b in each of the connecting parts are the same.

[0084] Specifically, the first connecting hole 102a at the first end of the beam 102 here is used to connect with the first connecting rod 103a, the second connecting hole 102b at the first end of the beam 102 is used to connect with the third connecting rod 103c, the first connecting hole 102a at the second end of the beam 102 is used to connect with the second connecting rod 103b, and the second connecting hole 102b at the second end of the beam 102 is used to connect with the fourth connecting rod 103d.

[0085] In order to realize the connection between different ends and the crossbeam 102 through multiple connecting rods, taking the first connecting rod 103a as an example, Figure 8 As shown, the two ends of the first connecting rod 103a are respectively provided with a third connecting hole 103a1 and a fourth connecting hole 103a2, the third connecting hole 103a1 of the first end of the first connecting rod 103a is used to connect with the first end 101a, and the fourth connecting hole 103a2 of the second end of the first connecting rod 103a is used to connect with the first end of the crossbeam 102, and can be connected with the first connecting hole 102a of the first end of the crossbeam 102. The third connecting hole 103a1 and the fourth connecting hole 103a2 here can be as shown in FIG. Figure 8 As shown, single hole or Fig.10 The double hole structure is used as shown. Fig. 9 As shown, one of the third connecting hole 103a1 and the fourth connecting hole 103a2 adopts a single hole structure, and the other adopts a double hole structure, wherein when the double hole structure is adopted, the spacing between the two holes in the third connecting hole 103a1 or the two holes in the fourth connecting hole 103a2 is the same. The structures of the second connecting rod 103b, the third connecting rod 103c and the fourth connecting rod 103d are the same as those of the first connecting rod 103a, and are not repeated here.

[0086] Specifically, regarding the connection between the second end of the first connecting rod 103a and the first end of the beam 102, the first connecting hole 102a at the first end of the beam 102 and the fourth connecting hole 103a2 at the second end of the first connecting rod 103a are arranged correspondingly, and the first connecting hole 102a and the fourth connecting hole 103a2 can adopt a single-hole structure or a double-hole structure. By setting different hole structures, the second end of the first connecting rod 103a and the first end of the beam 102 form a movable joint by having the beam axis pass through multiple coaxial holes.

[0087] Specifically, the first connection hole 102a and the fourth connection hole 103a2 of the first connecting rod 103a can adopt a single-hole structure or a double-hole structure. Specifically, the first connection hole 102a of the crossbeam 102 and the fourth connection hole 103a2 of the first connecting rod 103a can preferably form a three-hole coaxial structure, which can maximize the stability of the connection. For example, the first connection hole 102a of the crossbeam 102 can be set to a double-hole structure, and the fourth connection hole 103a2 of the first connecting rod 103a can be set to a single-hole structure; of course, it can also be the other way around, that is, the first connection hole 102a of the crossbeam 102 is set to a single-hole structure, and the fourth connection hole 103a2 of the first connecting rod 103a is a double-hole structure. In this way, by inserting the single-hole structure between the double-hole structures (so that the single-hole structure is on the inner side and the double-hole structure is located on both sides of the single-hole structure), three holes are coaxial and the beam axis is matched to pass through the three coaxial holes to realize the hinge between the second end of the first connecting rod 103a and the first end of the cross beam 102.

[0088] Furthermore, the beam axis here can be welded, bonded or anchored to the connecting hole located on the outside. Specifically, when the first connecting hole 102a of the cross beam 102 is a single-hole structure, the beam axis and the double-hole structure of the fourth connecting hole 103a2 of the first connecting rod 103a are fixedly connected. Conversely, if the first connecting hole 102a is a double-hole structure, the fourth connecting hole 103a2 of the first connecting rod 103a is a single-hole structure, then the beam axis and the double-hole structure of the first connecting hole 102a of the cross beam 102 are fixedly connected, so that the connecting hole located on the inside only needs to be put on the beam axis to form a movable joint structure.

[0089] In addition, since the first end and the second end of the beam 102 are respectively provided with connecting parts, each of the connecting parts, in addition to the connecting hole structure, can also adopt a connecting groove structure, and the two ends of the beam axis are welded and fixed to the connecting groove at the end of the beam 102. The second end of the first connecting rod 103a adopts a single hole structure to be sleeved on the connecting groove, and similarly, for example, the connection between the first connecting rod 103a and the beam 102 can be realized.

[0090] Furthermore, if Fig.11 and Fig.12 As shown, the first end of the first connecting rod 103a is connected to the first terminal 101a through the third connecting hole 103a1. Fig.13 As shown, the first terminal 101a here includes a main body 101a1 and a plurality of connecting terminals 101a2, the connecting terminals 101a2 are provided with terminal support grooves 101a3, and the main body 101a1 is provided with linkage rod connecting holes 101a4. The linkage rod connecting holes 101a4 here can be as follows Fig.11 As shown, it is arranged on the wall surface of the main body 101a1, and can also be arranged as shown in Fig.14 As shown, it is arranged on a raised portion on the main body 101a1.

[0091] Wherein, each of the end support grooves 101a3 of the first end 101a and the third connection hole 103a1 of the first connecting rod 103a preferably form a slot coaxial structure, for example, a beam axis is arranged on the end support groove 101a3, and the third connection hole 103a1 is sleeved on the beam axis, so as to maintain the stability of the connection. Specifically, a double-groove structure can also be adopted on the connecting end 101a2 of the first end 101a, and the third connection hole 103a1 of the first connecting rod 103a is a single-hole structure, which can increase the stability of the connection. If the connection between the first end 101a and the first connecting rod 103a adopts the structure of the end support groove 101a3, the two ends of the beam axis can be welded and fixed on the end support groove 101a3 of the first end 101a.

[0092] Furthermore, a link rod connection hole is provided on the side of each end, so as to facilitate setting a link rod 104 between the first end 101a and the third end 101c and between the second end 101b and the fourth end 101d. Fig.15As shown, taking the first end 101a as an example, when the linkage rod connection hole 101a4 on the main body 101a1 is used to connect the linkage rod 104, the rod body 1041 of the linkage rod 104 here is a rod-shaped structure, and connecting protrusions 1042 are provided at both ends thereof to be inserted into the linkage rod connection hole 101a4. The structure of the expansion frame of the first end 101a using the above-mentioned linkage rod connection hole 101a4 and its expansion and contraction states are shown in FIG. Figure 22-Figure 23 shown.

[0093] In this way, a movable joint is formed between the first end 101a and the first end of the first connecting rod 103a. Fig.13 As shown, of course, the structure of the end connection hole 101a5 is provided on the connecting end 101a2 of the first end 101a. The beam axis can be connected to the end connection hole 101a5 located on the outside by welding, bonding or anchoring, that is, the end connection hole 101a5 of the first end 101a is a single-hole structure, and the beam axis is fixed to the double-hole structure of the third connection hole 103a1 of the first connecting rod 103a. On the contrary, if the third connection hole 103a1 of the first connecting rod 103a is a single-hole structure, the beam axis is fixed to the third connection hole 101aB of the first end 101a. In this way, the end connection hole 101a5 located on the inner part is only sleeved on the beam axis to form a structure of a movable joint. The structure of the expansion frame of the first end 101a using the end connection hole 101a5 and its expanded and contracted states are shown in FIG. Figure 19-21 shown.

[0094] In this way, the first end 101a and the third end 101c form an isosceles trapezoid with a fixed base through the first connecting rod 103a, the crossbeam 102 and the fourth connecting rod 103d, and the second end 101b and the fourth end 101d form an isosceles trapezoid with a movable base through the third connecting rod 103c, the crossbeam 102 and the second connecting rod 103b. In this way, the fourth end 101d is driven to move toward or away from the first end 101a by the movement of the push tube 4 through the operation of the handle 5, which is equivalent to changing the length of the base of the isosceles trapezoid. In this way, when the length of the base is reduced, the height of the isosceles triangle or the isosceles trapezoid will increase, and when the length of the base is increased, the height of the isosceles triangle or the isosceles trapezoid will decrease.

[0095] Furthermore, if Fig.26 and Fig. 27 As shown, based on the structure of the expansion rack 1, the user can control the expansion or contraction of the expansion rack 1 by operating the handle 5, as shown in FIG. Fig.16As shown, when the crossbeam 102 in the expansion frame 1 is close to the guidewire cavity 3 (equivalent to the contracted state), the expansion frame 1 contracts to a smaller outer diameter, so that it can be delivered to the valve ring through the sheath from the distal vascular access to achieve minimally invasive intervention. Fig.17 As shown, after the expansion frame 1 reaches the valve ring and is positioned, the push tube 4 is moved forward by operating the handle 5 or the guide wire cavity 3 is moved backward while controlling the push tube 4 to move forward, thereby pushing the expansion frame 1 to expand outward to achieve expansion of the valve ring. It should be noted that the geometric structure of the expansion frame 1 here determines that the handle 5 pushes the push tube 4 forward or the guide wire cavity 3 moves backward while the push tube 4 moves forward, so that the crossbeam 102 will generate sufficient expansion force outward, thereby achieving expansion of the valve ring and creating space for artificial valve implantation. When the expansion frame 1 is being expanded, blood can flow smoothly through the expansion frame 1. The use of the expansion frame 1 can avoid the problems caused by blood flow blockage caused by balloon expansion, making the valve expansion process safe, simple and easy to promote.

[0096] In one embodiment, based on different expansion modes, the handle 5 adopts different structures. When it is necessary to push the push tube 4 to move in one direction, as shown in FIG. Fig.25 and Fig.26 As shown, the handle 5 includes a fixed portion 501 and a rotating portion 502, wherein the first portion of the rotating portion 502 is accommodated in the fixed portion 501 and rotates so as to be rotatably connected with the fixed portion 501, and the second portion of the rotating portion 502 is located outside the fixed portion 501, wherein the outer wall of the first portion of the rotating portion 502 is sleeved with the inner wall of the fixed portion 501; the push tube 4 is arranged outside the fixed portion 501 and penetrates into the fixed portion 501 from the distal end of the fixed portion 501. In addition, the guidewire cavity 3 penetrates from the proximal end of the handle 5 and exits from the distal end of the handle 5, and a joint 503 is arranged at the end of the guidewire cavity 3 for flushing the guidewire cavity 3.

[0097] Furthermore, a front end sliding member 506A is provided in the rotating part 502, and the front end sliding member 506A is connected to the proximal end of the pushing tube 4. A first internal thread 508A is provided on the inner wall of the front end of the rotating part 502, and the front end sliding member 506A is engaged with the first internal thread 508A. In addition, a guide rail 505 is provided in the fixing part 501, and the guide rail 505 is fixed in the fixing part 501 by the guide rail lock 504. The guide rail 505 passes through the front end sliding member 506A to provide a guiding function for the movement of the front end sliding member 506.

[0098] The expansion process of the expansion frame 1 here is a method in which the frame body is expanded toward the direction of the head 2. Specifically, the rotating part 502 rotates along the expansion direction of the expansion frame 1. Since the fixed part 501 prevents the guide rail 505 from rotating together with the rotating part 502 through the guide rail lock 504, the front end sliding member 506A can only move axially toward the distal end of the head 2, thereby driving the fourth end 101d to move toward the head 2 through the push tube 4. While the fourth end 101d moves, it drives the second end 101b to move forward together through the linkage rod 104. Here, the first end 101a and the third end 101c are fixed at the front end of the guide wire cavity 3 to keep their positions stationary or the first end 101a is fixed at the front end of the guide wire cavity 3, and the first end 101a and the third end 101c are kept stationary through the linkage rod 104. In this way, the relative movement of the first end 101a and the fourth end 101d causes the crossbeam 102 of the expansion frame 1 to expand outward quickly, thereby achieving the deployment of the expansion frame 1.

[0099] In another embodiment, the handle 5 is configured to enable the guidewire cavity 3 and the push tube 4 to move toward each other at the same time, so that the expansion frame 1 will remain in the center position after being positioned at the valve ring. In this embodiment, the handle 5 includes a fixed portion 501 and a rotating portion 502, the first part of the rotating portion 502 is accommodated in the fixed portion 501 and rotates so as to be rotatably connected with the fixed portion 501, and the second part of the rotating portion 502 is located outside the fixed portion 501, wherein the outer wall of the first part of the rotating portion 502 is sleeved with the inner wall of the fixed portion 501; the push tube 4 is arranged outside the fixed portion 501 and penetrates into the fixed portion 501 from the distal end of the fixed portion 501. In addition, the guidewire cavity 3 penetrates from the proximal end of the handle 5 and passes out from the distal end of the handle 5, and a joint 503 is arranged at the end of the guidewire cavity 3 for flushing the guidewire cavity.

[0100] A front end sliding member 506A and a rear end sliding member 506B are arranged in the rotating part 502, and the front end sliding member 506A is connected to the proximal end of the pushing tube 4. A first internal thread 508A is arranged on the inner wall of the front end of the rotating part 502, and a second internal thread 508B is arranged on the inner wall of the rear end of the rotating part 502. The front end sliding member 506A and the rear end sliding member 506B are respectively engaged with the first internal thread 508A and the second internal thread 508B.

[0101] The rotating part 502 rotates along the expansion direction of the expansion frame 1, and the fixed part 501 prevents the guide rail 505 from rotating together with the rotating part 502 through the guide rail lock 504, so that the front end sliding member 506A can only move axially toward the far end close to the head 2, thereby pushing the fourth end 101d to move in the direction of the head 2. While the fourth end 101d moves, it drives the second end 101b to move forward together through the linkage rod 104.

[0102] Considering that the rear end of the rotating part 502 is provided with a second internal thread 508B with a pattern opposite to the first internal thread 508A, similarly, when the guide rail 505 passes through the rear end sliding member 506B that matches the pattern of the second internal thread 508B. When the rotating part 502 rotates along the unfolding direction of the expansion frame 1, the rear end sliding member 506B can only move axially toward the rear end. The rear end portion of the guide wire cavity 3 here is connected to the rear end sliding member 506B, thereby pulling the first end 101a and the third end 101c to move backward. In this way, the relative movement of the first end 101a, the third end 101c and the second end 101b and the fourth end 101d causes the crossbeam 102 of the expansion frame 1 to expand outward rapidly.

[0103] In some other embodiments, the handle 5 can also be designed as a forward push type, a backward pull type or a bidirectional parallel structure. Among them, the forward push type or backward pull type structure can, for example, be provided with a button inside the handle 5 that extends to the outside of the handle, and the push tube 4 is moved by pushing the button forward or pulling it backward. Preferably, the forward push button is connected to the push tube 3, and the backward pull button is connected to the guide wire cavity 3.

[0104] In addition, the bidirectional parallel structure can, for example, be provided with a centrally fixed beam inside the handle 5, and the two sides of the beam are respectively connected to the guidewire cavity 3 and the push tube 4. Preferably, the rear side of the beam is connected to the guidewire cavity 3 and the front side is connected to the push tube 4. For example, the beam can be controlled by a button, and the expansion part 1 can be expanded by pushing the button forward and retracted; or an annular ring can be provided, and the rear end of one side of the ring is connected to the guidewire cavity 3, and the front end of the other side is connected to the push tube 4. In this way, through the connection between the button and the ring, the expansion part 1 can be expanded by pushing the button forward and retracted when retracted.

[0105] In order to solve the problems of excessively high operating requirements, short operating time, difficult positioning, difficult expansion, and limited expansion size brought about by balloon dilatation of the valve ring, the embodiment of the utility model has the characteristic of not blocking blood flow during the expansion process, thereby making positioning simple because it will not be affected by the double flow impact. Since there is no need to compress the liquid and the operating time requirements are simple, the expansion degree and expansion position can be accurately controlled. In addition, different specifications can be set according to needs, and there is no problem of insufficient expansion pressure or prolonged time. At the same time, the problem that non-compliant balloons cannot achieve large diameter size settings is solved.

[0106] In the above embodiments of the present invention, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0107] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used herein to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" may include both "above" and "below". The device may also be positioned in other different ways, rotated 90 degrees or in other orientations, and the spatially relative descriptions used herein are interpreted accordingly.

[0108] In addition to the above, it should be noted that "one embodiment", "another embodiment", "embodiment", etc. mentioned in this specification refer to the specific features, structures or characteristics described in conjunction with the embodiment included in at least one embodiment generally described in this application. The same expression appearing in multiple places in the specification does not necessarily refer to the same embodiment. Further, when describing a specific feature, structure or characteristic in conjunction with any embodiment, it is claimed that the realization of such feature, structure or characteristic in conjunction with other embodiments also falls within the scope of the present utility model.

[0109] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0110] The above description is only the preferred embodiment of the utility model, and is not intended to limit the utility model. For those skilled in the art, the utility model can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the utility model shall be included in the protection scope of the utility model.

Claims

1. A mechanical expansion device, characterized in that: It includes a head, a guide wire cavity and a handle which are connected in sequence. A push tube which can be controlled to slide by the handle is sleeved on the outer side of the guide wire cavity. An expansion part is arranged between the head and the push tube. The first end of the push tube is connected to the end of the expansion part. The second end of the push tube is connected to a sliding part in the handle. The expansion part can be expanded and contracted by sliding the push tube on the guide wire cavity.

2. The mechanical expansion device according to claim 1, characterized in that The expansion part adopts a basket structure, and the basket structure is formed by adopting a metal woven mesh tube structure, and the mesh tube structure is formed based on a single metal wire forming a spiral structure.

3. The mechanical expansion device according to claim 1, characterized in that The expansion part adopts the structure of an expansion frame, and the expansion frame includes a first end, a second end, a third end and a fourth end which are arranged on the guide wire cavity and in sequence along the extension direction of the guide wire cavity, the first end is fixedly connected to the distal end of the guide wire cavity, the third end is arranged on the guide wire cavity and its position relative to the first end remains unchanged, the fourth end is connected to the first end of the push tube, and the second end moves on the guide wire cavity. When the push tube moves relative to the head, the push tube drives the fourth end to move, and at the same time drives the second end to move.

4. The mechanical expansion device according to claim 3, characterized in that The expansion frame also includes a plurality of connecting rod portions. When the fourth end moves toward the direction approaching the first end, the expansion frame can form a lantern-shaped structure after being unfolded through the plurality of connecting rod portions. When the fourth end moves toward the direction away from the first end, the plurality of connecting rod portions of the expansion frame shrink and fit into the guidewire cavity.

5. The mechanical expansion device according to claim 4, characterized in that The connecting rod portion includes a first connecting rod, a cross beam and a second connecting rod connected in sequence, wherein the first end of the first connecting rod is connected to the first end head, the second end of the first connecting rod is connected to the first end of the cross beam, the second end of the cross beam is connected to the first end of the second connecting rod, the second end of the second connecting rod is connected to the fourth end head, the second end head is connected to the first end of the cross beam through a third connecting rod, and the third end head is connected to the second end of the cross beam in the connecting rod portion through a fourth connecting rod.

6. The mechanical expansion device according to claim 5, characterized in that A linkage rod is arranged between the second end and the fourth end, and the third end is fixed on the guide wire cavity or connected with the first end through the linkage rod.

7. The mechanical expansion device according to claim 6, characterized in that The first end and the second end of the crossbeam are respectively provided with connecting parts, each of the connecting parts includes a first connecting hole and a second connecting hole, the first connecting hole is arranged close to the end of the crossbeam relative to the second connecting hole, the first connecting hole at the first end of the crossbeam is used to connect with the first connecting rod, the second connecting hole at the first end of the crossbeam is used to connect with the third connecting rod, the first connecting hole at the second end of the crossbeam is used to connect with the second connecting rod, and the second connecting hole at the second end of the crossbeam is used to connect with the fourth connecting rod.

8. The mechanical expansion device according to claim 7, characterized in that The first connection hole and the second connection hole adopt a single-hole or double-hole structure.

9. The mechanical expansion device according to claim 7, characterized in that A third connecting hole and a fourth connecting hole are respectively provided at the two ends of the first connecting rod, the third connecting hole is used to connect with the first end head, and the fourth connecting hole is used to connect with the first end of the beam, and the third connecting hole and the fourth connecting hole adopt a single-hole or double-hole structure.

10. The mechanical expansion device according to claim 9, characterized in that The first terminal includes a main body and a plurality of connecting terminals, the connecting terminals are provided with a terminal support groove, and the terminal support groove and the third connecting hole form a slot-hole coaxial structure.

11. The mechanical expansion device according to claim 10, characterized in that A linkage rod connection hole is provided on the main body, and the linkage rod connection hole is arranged on the wall surface of the main body or on a protrusion on the wall surface of the main body.

12. The mechanical expansion device according to claim 11, characterized in that The connecting end of the first end is provided with an end connection hole.

13. The mechanical expansion device according to claim 1, characterized in that The handle includes a fixed part and a rotating part, the first part of the rotating part is accommodated in the fixed part and is rotatably connected to the fixed part, the second part of the rotating part is located on the outside of the fixed part, and the outer wall of the first part of the rotating part is sleeved with the inner wall of the fixed part; the pushing tube is arranged on the outside of the fixed part and penetrates into the fixed part from the distal end of the fixed part, the guide wire cavity penetrates from the proximal end of the handle and passes out from the distal end of the handle, and a joint is arranged at the end of the guide wire cavity for flushing the guide wire cavity.

14. The mechanical expansion device according to claim 13, characterized in that A front end sliding piece is arranged in the rotating part, and the front end sliding piece is connected to the proximal end of the pushing tube. A first internal thread is arranged on the inner wall of the front end of the rotating part, and the front end sliding piece is meshed with the first internal thread. A guide rail is arranged in the fixed part, and the guide rail is fixed in the fixed part by a guide rail lock. The guide rail passes through the front end sliding piece to provide a guiding function for the movement of the front end sliding piece.

15. The mechanical expansion device according to claim 14, characterized in that A front end sliding member and a rear end sliding member are arranged in the rotating part, the front end sliding member is connected to the proximal end of the pushing tube, a first internal thread is arranged on the inner wall of the front end of the rotating part, and a second internal thread is arranged on the inner wall of the rear end of the rotating part, and the front end sliding member and the rear end sliding member are respectively engaged with the first internal thread and the second internal thread.

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