A balloon catheter for aortic valve dilation

Abstract

A balloon catheter for aortic valve dilatation comprises an outer tube, an inner tube, a three-way tail seat and a balloon, wherein the inner tube passes through the outer tube, and one end of the inner tube and the outer tube is connected to the three-way tail seat, one end of the balloon is connected to the other end of the outer tube, and the other end of the balloon is connected to the other end of the inner tube, so that the balloon is wrapped outside the inner tube. The outer cover is designed to form a dense mesh structure at both ends of the outer cover, and a capture port with an aperture much larger than the particle size of calcification is formed in the middle. On the one hand, the balloon can be constrained when it is pressurized, so that the balloon after pressurization will not produce a dog bone phenomenon. On the other hand, after the balloon is depressurized, the calcification enters the capture port, and the dense parts at both ends wrap the calcification between the balloon and the outer cover, and finally it is taken out with the balloon catheter, thereby reducing the risk of complications such as stroke.

Description

Technical Field

[0001] The invention relates to the technical field of vascular interventional treatment, and in particular to a balloon catheter for aortic valve dilation. Background Art

[0002] Aortic stenosis is a common heart valve disease in the elderly. For severe aortic valve disease, surgical aortic valve replacement surgery was used to treat it in the past. However, surgical surgery is very traumatic. Transcatheter aortic valve implantation is characterized by less trauma and lower risk. This method has brought good news to patients with severe aortic valve stenosis, especially those who cannot tolerate open-chest surgery. Aortic balloon dilatation increases the mobility of the valve and the valve area by tearing the valve junction, thereby alleviating aortic valve stenosis. It has become a step in transcatheter aortic valve implantation, and aortic balloon dilatation catheters can also be used alone. At present, the aortic balloon dilatation catheters used in the market are mainly Z-MED balloon catheters and TyshakⅡ balloon catheters. When encountering a severely calcified aortic valve, the lesion is severely calcified. It is necessary to first use a small-sized balloon catheter to dilate the lesion, and then use a larger-sized balloon catheter to dilate. Multiple balloon dilatations may be required, which is cumbersome to operate, and the balloon dog bone is severely deformed during the balloon catheter dilatation process, and the calcified material may fall off and cause complications such as stroke. However, the existing balloon catheter cannot effectively remove the calcification that has fallen off the blood vessel when passing through the blood vessel wall, which increases the risk of stroke. Therefore, a balloon catheter for aortic valve dilation is proposed. Summary of the invention

[0003] The present invention solves the technical problem that the existing balloon catheter cannot remove the calcification on the blood vessel wall, and provides a balloon catheter for aortic valve dilation.

[0004] The technical solution provided by the present invention is as follows:

[0005] A balloon catheter for aortic valve dilatation comprises an outer tube, an inner tube, a three-way tail seat and a balloon, wherein the inner tube passes through the outer tube, and one end of the inner tube and the outer tube is connected to the three-way tail seat, one end of the balloon is connected to the other end of the outer tube, and the other end of the balloon is connected to the other end of the inner tube, so that the balloon is sleeved outside the inner tube, and further comprises an outer cover, which is wrapped around the outside of the balloon, and the two ends of the outer cover are connected to the two ends of the balloon, so that a middle part of the outer cover forms a plurality of mesh-shaped calcification capture ports, and the outer walls at both ends of the outer cover are dense parts to wrap the captured calcification.

[0006] In the present technical solution, an outer cover is provided so that a dense mesh structure is formed at both ends of the outer cover, and a calcification capture port is formed in the middle. When the balloon is pressurized, the expanded balloon will be squeezed out from the capture port to support the blood vessel wall. The outer cover constrains the two ends of the balloon, which not only prevents the dog bone phenomenon, but also removes plaques at the lesion site. Moreover, when the balloon is depressurized, the balloon contracts first and then the outer cover contracts, which can capture the calcified materials that fall off during the balloon expansion process. The calcification in the blood vessel enters the gap between the balloon and the fabric from the calcification capture port. After the outer cover contracts, the calcification is wrapped up and taken out of the body along with the balloon catheter, thereby reducing the occurrence of complications such as stroke.

[0007] Preferably, the outer cover comprises a metal bracket, the peripheral walls at both ends of the metal bracket are dense mesh structures, the middle portion is a plurality of mesh calcification capture ports, and the apertures of the meshes at both ends are smaller than the aperture of the meshes in the middle portion.

[0008] In the present technical solution, the metal stent is woven from metal wires, with dense meshes formed at both ends and metal wires crisscrossed in the middle to form a capture port, which can not only play a restraining role, but also play a role in capturing calcifications.

[0009] Preferably, the outer cover comprises woven fabric, two ends of the woven fabric are connected to two ends of the balloon, and a plurality of hole-shaped calcification capture openings are opened on the central peripheral wall of the woven fabric.

[0010] Preferably, the outer cover comprises a metal stent and two woven fabrics, the two woven fabrics are respectively connected to the two end peripheral walls of the metal stent to form a mesh-shaped calcification capture port in the middle, and the two ends of the metal stent are connected to the balloon through the woven fabrics.

[0011] Preferably, the outer cover comprises a metal bracket and two woven fabrics, the two woven fabrics are connected through the metal bracket, the two woven fabrics are respectively connected to two ends of the balloon to form a cylindrical structure sleeved outside the balloon, and the metal bracket has a calcification capture port.

[0012] Preferably, the metal wires on the metal stent located in the middle of the balloon are crisscrossed to form a calcification capture port.

[0013] Preferably, the woven fabric is connected to the inner wall sides or the outer wall sides of both ends of the metal bracket.

[0014] Preferably, the woven fabric and the metal bracket are connected by welding or sewing.

[0015] In the present technical solution, the woven cloth is welded or sewn onto the metal stent, and the two ends of the metal stent are fixed to the two ends of the balloon through the woven cloth. The material of the woven cloth is similar to that of the balloon, and the strength of the balloon catheter after welding is high. Compared with the prior art of directly welding the metal wire and the balloon together, the connection method in the present technical solution enables the metal stent to better play a restraining role after the balloon is expanded, and there is no risk of the metal wire breaking after the balloon is expanded.

[0016] Preferably, it also includes:

[0017] A tip portion, the tip portion being connected to the inner tube and an end of the balloon away from the three-way tailstock;

[0018] A developing ring is connected to a section of the outer wall of the inner tube located inside the balloon.

[0019] Compared with the prior art, the balloon catheter embodiment for aortic valve dilation provided by the present invention has the following beneficial effects:

[0020] 1. The present invention designs the outer cover to form a dense mesh structure at both ends of the outer cover, and a capture port with an aperture much larger than the particle size of the calcified material in the middle. On the one hand, the balloon can be constrained when the balloon is pressurized, so that the pressurized balloon will not produce a dog bone phenomenon. On the other hand, after the balloon is depressurized, the calcified material enters the capture port, and the dense parts at both ends wrap the calcified material between the balloon and the outer cover, and finally the calcified material is taken out together with the balloon catheter, thereby reducing the risk of complications such as stroke.

[0021] 2. In some embodiments of the present invention, by installing woven fabrics at both ends of a metal stent, the metal stent is installed outside a balloon. The material of the woven fabric and the balloon are similar. During welding, the woven fabric and the two ends of the balloon can be quickly welded together. The strength of the balloon catheter after installation is higher. Compared with the existing balloon catheter, the balloon is welded to the balloon through a metal wire. Therefore, after the balloon is expanded, since the material of the balloon is different from that of the metal wire, the strength after welding is not high, and there is a risk of the metal wire breaking after the balloon is expanded.

[0022] 3. The present invention installs woven fabrics at both ends of the metal stent so that the metal stent can be installed quickly. Since the materials of the woven fabric and the balloon are similar, they can be quickly welded together, which is easier than welding a metal wire and a balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The preferred implementation scheme will be described below in a clear and understandable manner in conjunction with the accompanying drawings to further illustrate the above-mentioned characteristics, technical features, advantages and implementation methods of a balloon catheter for aortic valve dilation.

[0024] Figure 1 It is a schematic structural diagram of an embodiment of a balloon catheter for aortic valve dilation according to the present invention;

[0025] Figure 2 It is a schematic structural diagram of another embodiment of a balloon catheter for aortic valve dilation of the present invention;

[0026] Figure 3 It is a schematic structural diagram of another embodiment of a balloon catheter for aortic valve dilation of the present invention;

[0027] Figure 4 It is a schematic structural diagram of another embodiment of a balloon catheter for aortic valve dilation of the present invention;

[0028] Figure 5 yes Figure 4 AA cross-sectional diagram of ;

[0029] Figure 6 It is a schematic structural diagram of another embodiment of a balloon catheter for aortic valve dilation of the present invention;

[0030] Figure 7 yes Figure 6 Schematic diagram of BB cross section.

[0031] Description of the accompanying drawings: tip portion 1, fabric 2, developing ring 3, balloon 4, metal bracket 5, inner tube 6, outer tube 7, three-way tailstock 8. DETAILED DESCRIPTION

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings and other implementation methods can be obtained based on these drawings without creative work.

[0033] In order to simplify the drawings, only the parts related to the invention are schematically shown in each figure, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some figures, only one of the parts with the same structure or function is schematically drawn or marked. In this article, "one" not only means "only one", but also means "more than one".

[0034] According to an embodiment provided by the present invention, Figure 1-7As shown, a balloon catheter for aortic valve dilatation includes an outer tube 7, an inner tube 6, a three-way tail seat 8 and a balloon 4. The inner tube 6 passes through the outer tube 7, and one end of the inner tube 6 and the outer tube 7 is connected to the three-way tail seat 8. During the specific implementation, one end of the outer tube 7 and the inner tube 6 are connected to the three-way tail tube, and are connected and fixed together by glue dispensing and curing. The other end of the inner tube 6 passes through the outer tube 7 and reaches the outside of the outer tube 7. One end of the balloon 4 is connected to the other end of the outer tube 7, and the other end of the balloon 4 is connected to the other end of the inner tube 6, so that the balloon 4 is sleeved on the outside of the inner tube 6. It also includes an outer cover. The shape of the outer cover is similar to that of the balloon 4. The outer cover is wrapped around the outside of the balloon 4 and matches the shape of the balloon 4, so that after the balloon 4 is pressurized and expanded, the outer cover can better fit the balloon 4. At the same time, the outer cover can also constrain the balloon 4, so that the expanded balloon 4 will not produce a dog bone phenomenon. During installation When the balloon 4 is inflated, the two ends of the outer cover are connected to the two ends of the balloon 4. In this embodiment, the connection method between the outer cover and the two ends of the balloon 4 is not limited. It is only necessary to connect the two ends of the balloon 4 to the outer cover, so that the middle part of the outer cover forms a calcification capture port with a plurality of meshes. The outer walls of the two ends of the outer cover are dense parts to wrap the captured calcification. When the balloon 4 is pressurized and expanded, the expanded balloon 4 is squeezed out from the calcification capture port to support the blood vessel wall. When the balloon 4 is depressurized and recovered, the balloon 4 will shrink quickly, and the shrinkage speed of the outer cover is slower than that of the balloon 4. At this time, the calcification falls from the capture port to the outer surface of the balloon 4. After the balloon is depressurized and shrinks, the outer cover also shrinks, wraps the calcification that falls into the capture port, and then takes it out of the body together with the balloon 4.

[0035] Specifically, it also includes a tip portion 1, which is connected to the inner tube 6 and the end of the balloon 4 away from the three-way tail seat 8. The tip portion 1 is connected to the balloon 4 and the inner tube 6 by welding, and the tip portion 1 is convenient for passing through blood vessels and crossing valves during surgery. The connection between the balloon 4 and the outer tube 7 and the balloon 4 and the tip portion 1 is welded to make the connection more secure. A section of the outer wall of the inner tube 6 located inside the balloon 4 is connected to a developing ring 3 so that the doctor can observe conveniently during surgery.

[0036] like Figure 1 As shown, in another specific embodiment of the present invention, the outer cover includes a metal bracket 5, and the metal bracket 5 is woven with metal wires. The surrounding walls woven with metal wires at both ends of the metal bracket 5 are in a dense mesh structure, so that the aperture of the mesh woven at both ends is smaller than the aperture of the calcification capture port, and the middle part is a plurality of mesh-like calcification capture ports woven with metal wires, and the aperture of the mesh in the middle part is much larger than the particle size of the calcification, and the dense parts at both ends are respectively connected to the two ends of the balloon 4 by welding.

[0037] The metal wires on the metal stent 5 located in the middle of the balloon 4 are crisscrossed to form a mesh-like calcification capture port. The crisscrossed metal wires form a uniformly distributed mesh, so that the expanded balloon 4 can be evenly extruded, ensuring the force balance of the metal stent 5.

[0038] like Figure 2 As shown, in another specific embodiment of the present invention, the outer cover includes a woven fabric 2, the two ends of the woven fabric 2 are connected to the two ends of the balloon 4, and a plurality of porous calcification capture ports are provided on the central peripheral wall of the woven fabric 2. In specific implementation, the material of the woven fabric 2 is selected to be close to that of the balloon 4, and it is necessary to ensure that the elasticity of the woven fabric 2 is weaker than that of the balloon 4. During welding, due to the similarity of the materials, the two are easily welded together, and the strength after welding is high. At the same time, the calcification capture ports are evenly distributed on the peripheral wall of the outer cover, so that the inflated balloon 4 can be squeezed out from the capture ports, so that the outer cover is subjected to balanced force and is not easily damaged. At the same time, the effect of wall support is also ensured. The dense parts at both ends of the woven fabric 2 have mesh holes smaller than those for capturing calcifications, so that the calcifications can be wrapped in the gap between the woven fabric 2 and the balloon 4 during use.

[0039] In another embodiment of the present invention, the outer cover includes a metal stent 5 and two woven fabrics 2, the two woven fabrics 2 are respectively connected to the two end walls of the metal stent 5 to form a mesh-shaped calcification capture port in the middle, and the two ends of the metal stent 5 are connected to the balloon 4 through the woven fabrics 2. In a specific implementation, the inner wall side or the outer wall side of the two ends of the metal stent 5 is connected to the woven fabrics 2. In a specific implementation, the woven fabrics 2 are connected to the inner wall of the metal stent 5 (such as Figure 6-7 As shown), or the fabric 2 is connected to the outer wall of the metal bracket 5 (as shown Figure 4-5 As shown), in this embodiment, the woven fabric 2 is connected to the inner wall of the metal bracket 5, and the connection between the woven fabric 2 and the metal bracket 5 is welding or suturing, and in this embodiment, the suturing method is adopted. At the same time, the connection between the metal bracket 5 and the balloon 4 is connected together by the woven fabric 2 connected to the metal bracket 5. The metal wires on the metal bracket 5 located in the middle of the balloon 4 are crisscrossed to form a mesh-like calcification capture port, and the calcification capture ports are evenly distributed on the peripheral wall of the outer cover, so that the balloon 4 after pressurization and expansion can be evenly extruded, and the metal bracket 5 can be balanced by force. In this embodiment, no excessive extension is made to other deformations.

[0040] like Figure 3As shown, in another embodiment of the present invention, the outer cover includes a metal bracket 5 and two woven fabrics 2, the two woven fabrics 2 are connected by the metal bracket 5, and the metal bracket 5 is located in the middle. In the specific implementation, the woven fabric 2 and the metal bracket 5 are connected by welding or suturing. In this embodiment, suturing is adopted, and the two woven fabrics 2 are respectively connected to the two ends of the balloon 4 to form a tubular structure that is sleeved outside the balloon 4. The metal wires on the metal bracket 5 located in the middle of the balloon 4 are crisscrossed to form a mesh-like calcification capture port.

[0041] The woven fabric in the above embodiment can be made of one of polyamide, polyether block polyamide, polypropylene, etc. There are no excessive restrictions on the specific selection of the woven fabric in the above embodiment, as long as it can be connected to the balloon and enhance the connection effect.

[0042] It should be noted that the above embodiments can be freely combined as needed. The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered as the protection scope of the present invention.

Claims

1. A balloon catheter for aortic valve dilatation, comprising an outer tube, an inner tube, a three-way tail seat and a balloon, wherein the inner tube passes through the outer tube, and one end of the inner tube and the outer tube is connected to the three-way tail seat, one end of the balloon is connected to the other end of the outer tube, and the other end of the balloon is connected to the other end of the inner tube, so that the balloon is sheathed outside the inner tube, characterized in that: It also includes an outer cover, which is wrapped around the balloon, and the outer cover includes a metal bracket and two woven fabrics. The peripheral walls at both ends of the metal bracket are dense mesh structures, and the middle part is a plurality of mesh calcification capture ports, and the mesh apertures at both ends of the metal bracket are smaller than the mesh apertures in the middle part; the woven fabric is connected to the balloon to connect the two ends of the metal bracket to the two ends of the balloon, so that the middle part of the outer cover is formed with a plurality of mesh calcification capture ports, and the outer walls at both ends of the outer cover are dense parts to wrap the captured calcifications.

2. A balloon catheter for aortic valve dilatation according to claim 1, characterized in that: The two woven fabrics are respectively connected to the two end peripheral walls of the metal bracket.

3. A balloon catheter for aortic valve dilatation according to claim 1, characterized in that: The two woven fabrics are connected through the metal bracket, and the two woven fabrics are respectively connected to two ends of the balloon. The metal bracket and the two woven fabrics together form a cylindrical structure sleeved outside the balloon.

4. A balloon catheter for aortic valve dilation according to any one of claims 1 to 3, characterized in that: The metal wires on the metal stent located in the middle of the balloon are crisscrossed to form a calcification capture port.

5. A balloon catheter for aortic valve dilation according to claim 2, characterized in that: The inner wall periphery or the outer wall periphery of both ends of the metal bracket is connected to the woven fabric.

6. A balloon catheter for aortic valve dilation according to any one of claims 1 to 3, characterized in that: The woven fabric and the metal support are connected by welding or sewing.

7. A balloon catheter for aortic valve dilation according to any one of claims 1 to 3, characterized in that: The calcification capturing openings are evenly distributed on the peripheral wall of the outer cover.

8. A balloon catheter for aortic valve dilatation according to claim 1, characterized in that: Also includes: A tip portion, the tip portion being connected to the inner tube and an end of the balloon away from the three-way tailstock; A developing ring is connected to a section of the outer wall of the inner tube located inside the balloon.

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