Pre-plastic sheathing canal, coronary artery angiography device and interventional therapy device

Abstract

The utility model discloses a pre-plasticized sheathing canal, a coronary angiography device and an interventional therapy device. The pre-plasticized sheathing canal comprises a catheter part, a bent leading-out part and a positioning part, wherein the catheter part is internally provided with a catheter cavity; the bent leading-out part is provided with a leading-out hole communicated with the catheter cavity; the conduit part is in smooth transition connection with the positioning part through the bent leading-out part; the positioning part can be placed in the internal area of the artificial aortic valve above the artificial valve leaflet for positioning; the plane where the positioning part in contact with the inner wall of the artificial aortic valve frame is located is obliquely arranged or vertically arranged at a certain angle relative to the catheter part; the bending leading-out part and the positioning part can be in an elastic deformation state when being subjected to external force, and after the external force is relieved, the bending leading-out part and the positioning part automatically recover to the original state. The guide-out position of the coronary angiography catheter or the coronary guide catheter can be guaranteed, and the convenience that the coronary angiography catheter or the coronary guide catheter enters the opening position of the coronary artery or extends into the coronary artery is improved.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of coronary angiography, especially to a pre-plastic sheath tube, a coronary angiography device and an interventional therapy device. BACKGROUND

[0002] Coronary angiography refers to placing a coronary angiography catheter to the opening part of the coronary artery, and then injecting contrast medium directly into the coronary artery, thereby clearly and dynamically displaying the position, degree and nature of coronary artery stenosis. Coronary artery intervention refers to the operation of sending a guide wire, balloon, stent and other interventional instruments through the coronary guide catheter, thereby treating coronary artery stenosis and occlusion.

[0003] During coronary angiography, the doctor will puncture the radial artery or femoral artery to place a vascular sheath, and then send a coronary angiography catheter to the coronary artery opening through the sheath tube. The profile of the coronary artery is displayed by injecting contrast medium through the tail end of the coronary angiography catheter.

[0004] During coronary artery intervention, the doctor will puncture the radial artery or femoral artery to place a vascular sheath, and then send a coronary guide catheter to the coronary artery opening through the sheath tube. The guide wire, balloon, stent and other interventional instruments are sent through the coronary guide catheter to achieve coronary artery intervention.

[0005] In clinical practice, it is found that after transcatheter aortic valve implantation surgery, the in-situ valve leaflet, metal stent net or semi-membrane area in the artificial aortic valve will block the coronary artery opening to some extent. During coronary angiography or coronary artery intervention, due to the blockage of the in-situ valve leaflet, metal stent net or semi-membrane area in the artificial aortic valve, the coronary angiography catheter or coronary guide catheter cannot reach the coronary artery opening part. In addition, due to the blockage of the in-situ valve leaflet, metal stent net or semi-membrane area in the artificial aortic valve, the coronary angiography catheter or coronary guide catheter cannot reach the coronary artery opening or cannot maintain good coaxiality with the coronary artery, which makes the coronary imaging unclear or the interventional therapy equipment cannot enter the coronary artery.

[0006] Therefore, it is necessary to provide a new technical solution to solve the above problems. UTILITY MODEL CONTENT

[0007] To solve the above technical problems, the application provides a pre-plastic sheath tube and a coronary angiography device, which can rely on the positioning of the positioning part in the artificial aortic valve to ensure the guide-out position of the coronary angiography catheter or the coronary guide catheter, thereby improving the convenience of the coronary angiography catheter or the coronary guide catheter entering the coronary artery opening position or extending into the coronary artery.

[0008] A pre-molded sheath, comprising: a catheter part, a curved leading-out part, and a positioning part;

[0009] The catheter part has a catheter cavity inside;

[0010] The catheter part is connected to the positioning part through the curved leading-out part, and the curved leading-out part is provided with a leading-out hole in communication with the catheter cavity;

[0011] The positioning part can be placed in the inner area of the artificial aortic valve above and contact the inner wall of the artificial aortic valve frame to realize the positioning of the pre-molded sheath;

[0012] The plane where the positioning part contacts the inner wall of the artificial aortic valve frame is arranged at an angle relative to the catheter part or is arranged vertically; the curved leading-out part and the positioning part can be in an elastically deformed state when subjected to external force, and automatically return to the original state after the external force is removed.

[0013] Preferably, when the pre-molded sheath is in an elastically deformed state, the catheter part, the curved leading-out part, and the positioning part can be inserted into the blood vessel.

[0014] Preferably, when the plane where the positioning part contacts the inner wall of the artificial aortic valve frame is arranged at an angle relative to the catheter part, the included angle is less than 90 degrees and not less than 70 degrees.

[0015] Preferably, the projection of the curved leading-out part on the plane where the positioning part is located does not exceed the outermost boundary of the positioning part.

[0016] Preferably, the positioning part is a circular ring structure with a number of turns not less than 1.

[0017] Preferably, the positioning part is a circular arc structure with a central angle greater than 180 degrees.

[0018] Preferably, the outer diameter of the circle where the positioning part is located ranges from 1 cm to 4 cm.

[0019] Preferably, the inner diameter of the catheter part ranges from 5F to 12F.

[0020] Preferably, the pre-molded sheath further comprises a visible band for developing and positioning the leading-out hole.

[0021] Preferably, the catheter part, the curved leading-out part, and the positioning part are integrally formed.

[0022] Preferably, the catheter part, the curved leading-out part, and the positioning part are made by splicing assembly.

[0023] According to another aspect of the utility model, provide a kind of coronary angiography device, including the pre-plastic sheath and coronary angiography catheter;The coronary angiography catheter can be inserted into the catheter cavity inside catheter portion, and can be worn by the export hole.

[0024] Preferably, the coronary angiography device further includes a contrast guide wire that can be inserted into the coronary angiography catheter.

[0025] According to another aspect of the utility model, provide a kind of coronary intervention treatment device, including the pre-plastic sheath and coronary guide catheter;The coronary guide catheter can be inserted into the catheter cavity inside catheter portion, and can be worn by the export hole.

[0026] Preferably, the coronary intervention treatment device further includes a contrast guide wire and / or a guide guide wire that can be inserted into the coronary guide catheter.

[0027] Compared with the prior art, the present application has at least the following beneficial effects:

[0028] 1. The pre-plastic sheath of the utility model can position the blood vessel length direction in the artificial aortic valve by the positioning part, so that the export hole is close to the coronary ostium position in the vertical direction, and the accuracy and convenience of the coronary angiography catheter or coronary guide catheter after being worn by the export hole are improved.

[0029] 2. The pre-plastic sheath of the utility model can be supported by the positioning part, and the catheter support force is increased when the pre-plastic sheath is used for coronary angiography or interventional therapy, and the system stability is improved.

[0030] 3. The pre-plastic sheath of the utility model has a circular ring transition curved export part, which can ensure the smoothness of the coronary angiography catheter or coronary guide catheter export and positioning, effectively improve the operation efficiency of coronary angiography or interventional therapy, and effectively reduce the amount of contrast agent.

[0031] 4. The positioning part of the utility model is a circular ring structure or a circular arc structure with a central angle greater than 180 degrees, which can rotate along the inner wall of the artificial aortic valve frame by twisting the catheter part, effectively control the position and distance of the export hole relative to the coronary ostium, and further improve the operation convenience of coronary angiography or interventional therapy.

[0032] 5. When performing imaging operation or interventional therapy, the pre-plastic sheath of the utility model is positioned above the artificial valve leaflet by the positioning part, which can effectively reduce the damage of the pre-plastic sheath to the artificial valve leaflet. BRIEF DESCRIPTION OF DRAWINGS

[0033] Some specific embodiments of the present application will be described in detail below with reference to the accompanying drawings, which are presented by way of illustration and not of limitation. The same reference numbers in the drawings indicate the same or similar components or parts. Those skilled in the art will appreciate that the drawings are not necessarily drawn to scale.

[0034] In the drawings:

[0035] Figure 1 Structure diagram of artificial aortic valve;

[0036] Figure 2 Heart aorta diagram with artificial aortic valve after artificial aortic valve implantation operation;

[0037] Figure 3 Heart aorta diagram of coronary artery opening position after artificial aortic valve implantation operation;

[0038] Figure 4 Schematic diagram of the stereoscopic structure of the pre-shaped sheath tube in Embodiment 1 of the present application;

[0039] Figure 5 Top view of the pre-shaped sheath tube in Embodiment 1 of the present application;

[0040] Figure 6 Structure diagram of the coronary angiography device in Embodiment 1 of the present application;

[0041] Figure 7 Schematic diagram of the stereoscopic structure of the pre-shaped sheath tube in Embodiment 2 of the present application;

[0042] Figure 8 Top view of the pre-shaped sheath tube in Embodiment 2 of the present application;

[0043] Figure 9 Structure diagram of the coronary angiography device in Embodiment 2 of the present application.

[0044] Among them, the above drawings include the following reference signs:

[0045] 1, catheter part; 2, curved guide-out part; 3, positioning part; 4, guide-out hole; 11, pre-shaped sheath tube; 12, coronary angiography catheter; 100, aorta; 200, artificial aortic valve; 201, stent frame strip; 202, artificial valve leaflet; 203, frame hole; 204, half-covered membrane area; 205, full-covered membrane area; 300, native aortic valve; 400, coronary artery opening. DETAILED DESCRIPTION

[0046] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0047] like Figures 1-3 As shown, aortic valve replacement surgery is a procedure in which an artificial aortic valve 200 is placed in the position of the native aortic valve 300, and the artificial aortic valve 200 replaces the native aortic valve 300.

[0048] Commercially available artificial aortic valves 200 generally include a stent frame 201, an artificial leaflet 202, and a partially covered area 204 and a fully covered area 205. The stent frame 201 forms the artificial aortic valve frame, which is used to fix and support the artificial leaflet 202. There are frame holes 203 between adjacent stent frames 201.

[0049] The inner wall of the frame formed by the stent frame 201 below the artificial valve leaflet 202 is covered with a semi-covered area 204 and a fully covered area 205. The fully covered area 205 is located below the semi-covered area 204, completely sealing the frame openings 203 formed between adjacent stent frame frames 201 within its covered area. This allows blood flowing from the heart to enter the closed area formed by the fully covered area 205 and flow out above the artificial valve leaflet 202, while preventing blood from flowing back into the heart through the frame openings 203. The semi-covered area 204 covers the connection area between the artificial valve leaflet 202 and the stent frame 201, and the area between adjacent artificial valve leaflets 202 is not covered. The frame openings 203 above the artificial valve leaflet 202 are not covered, ensuring that blood flowing from the aorta 100 can enter the coronary arteries.

[0050] Since the distance between the coronary artery opening 400 and the native aortic valve 300 is relatively close, the stent frame 201 or the half-covered membrane area 204 in the artificial aortic valve 200 can also block the coronary artery opening 400 after the patient receives the artificial aortic valve 200 replacement surgery. When the coronary angiography is performed, due to the blockage of the native aortic valve 300, the stent frame 201 or the half-covered membrane area 204 in the artificial aortic valve 200, when the angiography catheter is inserted into the coronary artery or placed in the coronary artery opening 400 for angiography, the outlet end of the angiography catheter is difficult to pass out of the frame hole 203 close to the coronary artery opening 400 and reach the coronary artery opening 400, or the outlet end of the angiography catheter passes out of the frame hole 203 far from the coronary artery opening 400, which is limited by the stent frame 201 and is not conducive to the outlet end of the angiography catheter to pass out to reach the coronary artery opening 400. The above-mentioned situation makes the operation of the coronary angiography catheter or the coronary guide catheter difficult and the operation time long during the coronary angiography or interventional treatment. At the same time, in the above-mentioned situation, the distance between the outlet end of the angiography catheter and the coronary artery opening 400 is far, which not only causes a large amount of developer, but also causes poor angiography effect, and cannot effectively perform coronary angiography.

[0051] The utility model provides a kind of pre-plastic sheath, comprising: catheter portion, curved guide-out portion and positioning portion;

[0052] The catheter portion has a catheter cavity inside;

[0053] The catheter portion is connected with the positioning portion through the curved guide-out portion and is smoothly connected;The curved guide-out portion is provided with a guide-out hole communicated with the catheter cavity;

[0054] The positioning portion can be placed in the internal area of artificial aortic valve above artificial valve leaflet, and contact with the inner wall of artificial aortic valve frame to realize the positioning of the pre-plastic sheath;

[0055] The plane where the positioning portion contacts with the inner wall of artificial aortic valve frame is inclined or vertically arranged relative to the catheter portion;The curved guide-out portion and the positioning portion can be in elastic deformation state when subjected to external force, and automatically restore to original state after the external force is removed.

[0056] It should be noted that the plane where the positioning portion contacts with the inner wall of artificial aortic valve frame is actually the outer side wall between the plane where the center of the positioning portion is located and the bottom surface of the positioning portion, or the bottom surface of the positioning portion. When the positioning portion is placed in the internal area of artificial aortic valve above artificial valve leaflet, the outer side wall directly contacts with the internal area of artificial aortic valve above artificial valve leaflet, so that the artificial aortic valve frame can support the positioning portion.

[0057] By relying on the positioning function of the positioning part within the artificial aortic valve 200 and the guiding function of the curved exit part, the pre-molded sheath of this invention can guide the angiography catheter, facilitating the catheter to pass through the frame hole 203 of the artificial aortic valve 200 at an appropriate position or allowing the catheter to enter the space between the artificial aortic valve 200 and the inner wall of the aorta 100 more easily. This allows the contrast agent outlet of the angiography catheter to enter the vicinity of the coronary artery opening 400 more quickly or to extend into the coronary artery more quickly for contrast agent supply, thereby improving the contrast effect of the coronary artery.

[0058] Example 1

[0059] like Figures 4-5 As shown, and refer to Figures 1-3 A pre-shaped sheath includes: a catheter portion 1, a curved exit portion 2, and a positioning portion 3. The catheter portion 1 has a catheter lumen inside. The catheter portion 1 is smoothly connected to the positioning portion 3 via the curved exit portion 2. The curved exit portion 2 has an exit hole 4 communicating with the catheter lumen. The positioning portion 3 can be inserted into the internal region of the artificial aortic valve 200 above the artificial valve leaflet 202 and contacts the inner wall of the artificial aortic valve frame to achieve positioning of the pre-shaped sheath.

[0060] In addition, it should be noted that the positioning part 3 is a tubular structure with an internal cavity, or it can be a solid tubular structure without a cavity.

[0061] It should be noted that when the positioning part 3 is a tubular structure with an internal cavity, it can be lighter and can effectively reduce the overall weight of the pre-plasticized sheath. When the positioning part 3 has a cavity, there is a barrier between the cavity and the catheter lumen inside the catheter part 1 and the outlet port 4 to prevent the coronary angiography catheter or coronary guidance catheter inside the catheter lumen from penetrating into the cavity of the positioning part 3.

[0062] Furthermore, when the positioning part 3 is a tubular structure with an internal cavity and there is no diaphragm or corresponding barrier structure between it and the curved outlet part 2, the cavity is connected to the catheter lumen inside the catheter part 1 and the outlet hole 4. Since the curved outlet part 2 is curved, when the coronary angiography catheter or coronary guidance catheter inside it is inserted into the inlet end of the outlet hole 4, it can pass through the outlet end of the outlet hole 4 under the guidance of the curved outlet part 2.

[0063] It should be noted that when the positioning part 3 is a solid tubular structure without a cavity, it can block the catheter lumen inside the catheter part 1, effectively preventing the coronary angiography catheter or coronary guidance catheter inside the catheter lumen from entering the wrong position instead of passing through the outlet hole 4.

[0064] The plane where the positioning part 3 in contact with the inner wall of the artificial aortic valve frame is arranged perpendicularly relative to the catheter part 1. This form enables the positioning part 3 to make good contact with the stent frame strip 201 after entering the internal area of the artificial aortic valve 200 above the artificial valve leaflet 202, thereby ensuring that the supporting and positioning functions are achieved.

[0065] It should be noted that when the plane where the positioning part 3 in contact with the inner wall of the artificial aortic valve frame is arranged perpendicularly relative to the catheter part 1, the angle between the plane and the catheter part 1 is not 90 degrees, i.e., not perpendicular, due to the natural curvature of the aorta 100 and the size limitation of the aorta 100 lumen after entering the aorta 100. In addition, due to processing errors or product deformation caused by internal stress or external force after processing, the angle between the plane where the positioning part 3 in contact with the inner wall of the artificial aortic valve frame and the catheter part 1 is not 90 degrees, i.e., not perpendicular. In this case, the pre-shaped sheath also meets the requirements of the present scheme and can solve the corresponding technical problems.

[0066] The curved leading-out part 2 and the positioning part 3 can be in an elastically deformed state when subjected to external force, and automatically return to the original state after the external force is removed.

[0067] When the pre-shaped sheath is in an elastically deformed state, the catheter part 1, the curved leading-out part 2, and the positioning part 3 can all be inserted into the blood vessel. In this form, the pre-shaped sheath can pass through the artery, especially the femoral artery or radial artery, and extend into the internal area of the artificial aortic valve 200 above the artificial valve leaflet 202 in the aorta 100, thereby guiding the contrast catheter to enter the coronary artery opening 400 or extend into the coronary artery.

[0068] The positioning part 3 is a circular arc structure with a central angle greater than 180 degrees. The circular arc structure with a central angle greater than 180 degrees can form a triangular support point on its plane, which has better stability. It should be noted that in the circular arc structure with a central angle greater than 180 degrees, the range of the arc angle is greater than 180 degrees and less than 360 degrees. When the central angle of the circular arc structure is 360 degrees, it actually forms a circular ring structure rather than a circular arc structure.

[0069] Preferably, the projection of the curved leading-out part 2 on the plane where the positioning part 3 is located does not exceed the outermost boundary of the positioning part 3. If the projection of the curved leading-out part 2 on the plane where the positioning part 3 is located exceeds the outermost boundary of the positioning part 3, it will affect the free rotation positioning of the positioning part 3 on the inner wall of the artificial aortic valve 200.

[0070] In the embodiment, the projection of the curved leading-out portion 2 on the plane where the positioning portion 3 is located is located on the annular ring where the positioning portion 3 is located.

[0071] Preferably, the outer diameter of the circle where the positioning portion 3 is located ranges from 1 cm to 4 cm. It should be noted that the outer diameter of the circle where the positioning portion 3 is located can be any size within the range from 1 cm to 4 cm, according to different models of the artificial aortic valve 200 and different production sizes of various manufacturers.

[0072] In the embodiment, the catheter portion 1, the curved leading-out portion 2, and the positioning portion 3 are integrally formed. The integrally formed processing mode can make the catheter portion 1, the curved leading-out portion 2, and the positioning portion 3 more smooth at the connection, and not easy to damage the inner wall of the blood vessel when entering the human body through the artery. At the same time, the integrally formed structure makes the pre-plastic sheath have better strength and toughness, preventing the catheter portion 1, the curved leading-out portion 2, and the positioning portion 3 from being broken when being inserted into the artery.

[0073] In another embodiment of the utility model, the catheter portion 1, the curved leading-out portion 2, and the positioning portion 3 are made by splicing assembly. Specifically, the catheter portion 1, the curved leading-out portion 2, and the positioning portion 3 are separately produced and assembled together according to the process requirements after being produced to form the pre-plastic sheath. The separate production of the catheter portion 1, the curved leading-out portion 2, and the positioning portion 3 can realize the different setting of the material, structure, and shape of the three, and can effectively reduce the process difficulty and production cost when the material, structure, and shape of each part are different.

[0074] In addition, the catheter portion 1 and the curved leading-out portion 2 can also be produced together, and the positioning portion 3 is separately produced. After the catheter portion 1 and the curved leading-out portion 2 are produced, and the positioning portion 3 is produced, they are assembled together according to the process requirements to form the pre-plastic sheath.

[0075] In addition, the curved leading-out portion 2 and the positioning portion 3 can also be produced together, and the catheter portion 1 is separately produced. After the curved leading-out portion 2 and the positioning portion 3 are produced, and the catheter portion 1 is produced, they are assembled together according to the process requirements to form the pre-plastic sheath.

[0076] Preferably, the outer diameter of the catheter portion 1 is not greater than 10F. The catheter portion 1 with an outer diameter not greater than 10F can better adapt to the size in the artery, so that the pre-plastic sheath has better adaptability.

[0077] At the same time, the inner diameter of the catheter portion 1 is not less than 5F. The catheter portion 1 with an inner diameter not less than 5F can have a larger operation space, so that the pre-plastic sheath has better accommodation, and various specifications and models of coronary angiography catheters or coronary guide catheters can be inserted therein to perform corresponding angiography or interventional surgery.

[0078] It should be noted that the outer diameter of the catheter portion 1, the curved leading portion 2 and the positioning portion 3 can be of different sizes according to the production process, production cost and the requirement of the support of the pre-shaped sheath tube wall after production. For example, the positioning portion 3 does not need to accommodate the passage of the contrast catheter or the guide catheter, so the influence of the outer diameter on the internal cavity does not need to be considered, and thus the outer diameter of the positioning portion 3 can be smaller than that of the catheter portion 1 and the curved leading portion 2.

[0079] In the embodiment, the sizes of the catheter portion 1, the curved leading portion 2 and the positioning portion 3 are the same, and the inner diameter of the catheter portion 1 is 6F. When performing coronary angiography or coronary intervention, the catheter portion 1 with an inner diameter of 6F can have a catheter lumen with a large size while having good adaptability, facilitating the insertion of the contrast catheter into the internal catheter lumen. At the same time, according to the current sheath processing technology, the catheter portion 1 with an inner diameter of 6F can be inserted into the radial artery, the femoral artery and the carotid artery, and coronary angiography can be performed through any one of the radial artery, the femoral artery and the carotid artery as an access, having wider adaptability.

[0080] In another embodiment of the utility model, when the pre-shaped sheath tube is inserted through the radial artery, the inner diameter of the catheter portion 1 is not less than 5F, and under this size, the pre-shaped sheath tube can have good adaptability with the radial artery. When the inner diameter of the catheter portion 1 is less than 5F, the support force is low, and it is difficult to pass the corresponding instrument through the internal portion.

[0081] In another embodiment of the utility model, when the pre-shaped sheath tube is inserted through the femoral artery or the carotid artery, the inner diameter of the catheter portion 1 is not less than 5F, and under this size, the pre-shaped sheath tube can have good adaptability with the femoral artery or the carotid artery. Similarly, when the inner diameter of the catheter portion 1 is less than 5F, the support force is low, and it is difficult to pass the corresponding instrument through the internal portion.

[0082] In addition, when the pre-shaped sheath tube is inserted through the femoral artery, the inner diameter of the catheter portion 1 can be as thick as 20F, but the catheter portion 1 with an inner diameter of 20F can cause great damage to the blood vessel. Therefore, in the embodiment, the inner diameter of the catheter portion 1 in the pre-shaped sheath tube is at most 12F. As a preferred embodiment of the utility model, the inner diameter of the pre-shaped sheath tube of the utility model is not more than 8F.

[0083] Preferably, the pre-shaped sheath tube comprises an outer layer, a middle layer and an inner layer, and has a three-layer structure. The inner and outer layers are made of commonly used medical plastic materials, and the middle layer is made of a metal woven mesh. It should be noted that the commonly used medical plastic materials can be nylon, polytetrafluoroethylene, polyethylene or polypropylene.

[0084] As an embodiment of the utility model, the outer layer is polyethylene plastic material, which determines the shape, hardness and friction force of the guide catheter with the blood vessel intima, the middle layer is a structure made of 12 to 16 steel wires, the weaving mode of the middle layer metal woven mesh determines the supporting force, inner diameter and torsion control property of the pre-shaped sheath, and the inner layer is a nylon PTEE coating layer, which reduces the friction force between the coronary angiography catheter, contrast guide wire, guide guide wire, balloon, stent and catheter lumen of the catheter part 1, and prevents thrombosis.

[0085] As another embodiment of the utility model, the positioning part 3 is a circular ring structure. The circular ring structure of the positioning part 3 has better adaptability with the internal area of the artificial aortic valve 200 above the artificial valve leaflet 202. The circular ring structure is a circular ring structure with 1 number of turns, and can also be a circular ring structure with more than 1 number of turns. When the positioning part 3 is a circular ring structure with more than 1 number of turns, multiple circular rings can be stacked in the axial direction. It should be noted that when the positioning part 3 is a circular ring structure with more than 1 number of turns, the diameters of the circular rings in the axial direction are the same. In addition, when the positioning part 3 is a circular ring structure with more than 1 number of turns, the outer diameters of the circular rings in the axial direction can also be different, especially to adapt to the internal area of the artificial aortic valve 200 above the artificial valve leaflet 202, the outer diameter of the upper circular ring is greater than that of the lower circular ring or the outer diameter of the lower circular ring is greater than that of the upper circular ring.

[0086] As another embodiment of the utility model, the positioning part 3 can also be a deformation body of a circular ring, for example, the positioning part 3 can have a protruding point or a protruding block in the axial direction of the circular ring, or can be twisted in the axial direction of the circular ring to protrude or have a protrusion on the upper and lower surfaces of the circular ring.

[0087] As another embodiment of the utility model, the pre-shaped sheath further comprises a visible band for developing and positioning the guide hole 4. The visible band can be fixed to the upper or lower part of the guide hole 4, or can be arranged on the side surface of the curved guide part 2 at the position of the guide hole 4.

[0088] Preferably, the visible band is a developing layer adhered to the outer wall or inner wall of the curved guide part 2, or a developing material coated on the outer wall or inner wall of the curved guide part 2.

[0089] As another embodiment of the utility model, the visible band is a metal ring, metal wire or metal sheet fixed to the outer wall or inner wall of the curved guide part 2 which can be developed.

[0090] As another embodiment of the utility model, the visible band can also be a metal ring, metal wire or metal sheet fixed to the inner part of the pipe body of the curved guide part 2 which can be developed.

[0091] As another embodiment of the utility model, as Figure 6As shown, the coronary angiography device also includes a pre-shaped sheath 11 and a coronary angiography catheter 12. The pre-shaped sheath 11 is any of the possible technical solutions in the above embodiments. The coronary angiography catheter 12 can be inserted into the catheter lumen and can be pulled out through the guide hole 4. The coronary angiography catheter 12 is used to inject a contrast agent into the coronary artery to achieve coronary angiography.

[0092] As another embodiment of the present application, the coronary angiography device further includes a contrast guide wire that can be inserted into the coronary angiography catheter 12. The contrast guide wire can be inserted into the coronary angiography catheter 12 to improve the mechanical properties of the pre-shaped sheath 11 and the coronary angiography catheter 12, and to guide the sheath into the aorta without damaging the blood vessel wall, thereby improving the operation convenience of the coronary angiography device. It should be noted that in use, the contrast guide wire, the coronary angiography catheter 12 and the pre-shaped sheath 11 are nested, i.e. the contrast guide wire is inserted into the coronary angiography catheter 12, the coronary angiography catheter 12 is inserted into the pre-shaped sheath 11, and the three are inserted into the artery of the human body as an integrated structure, and enter the pre-set diagnosis position of the artificial aortic valve through the artery. After the contrast guide wire, the coronary angiography catheter 12 and the pre-shaped sheath 11 enter the pre-set diagnosis position of the artificial aortic valve, the contrast guide wire can be pulled out, and then a contrast agent is injected through the coronary angiography catheter 12. In addition, it should be noted that in the case that the contrast guide wire and the inner wall of the coronary angiography catheter 12 have a large enough space, the injection of the contrast agent can be performed in the state that the contrast guide wire is inserted into the coronary angiography catheter 12.

[0093] As another embodiment of the present application, the coronary angiography device also includes a pre-shaped sheath 11 and a coronary angiography catheter 12. The pre-shaped sheath 11 is any of the possible technical solutions in the above embodiments. The coronary angiography catheter 12 can be inserted into the catheter lumen and can be pulled out through the guide hole 4. The coronary angiography catheter 12 is used to inject a contrast agent into the coronary artery to achieve coronary angiography.

[0094] Further, the coronary intervention device further comprises a contrast guide wire capable of being inserted into the coronary guide catheter. The contrast guide wire is capable of being inserted into the coronary guide catheter for improving the rigidity and other mechanical properties of the pre-shaped sheath 11 and the coronary guide catheter, and capable of guiding the coronary guide catheter to improve the operation convenience of the coronary intervention device. It should be noted that in use, the contrast guide wire, the coronary guide catheter and the pre-shaped sheath 11 are nested, that is, the contrast guide wire is inserted into the coronary guide catheter, the coronary guide catheter is inserted into the pre-shaped sheath 11, and the three are simultaneously inserted into the artery of the human body as an integrated structure, and enter the preset diagnosis position of the artificial aortic valve through the artery. After the end of the contrast guide wire, the coronary guide catheter and the pre-shaped sheath 11 enter the preset position of the artificial aortic valve, the contrast guide wire can be pulled out, and then the guide wire is sent into the diseased blood vessel through the coronary guide catheter, and the balloon and the stent are sent along the guide wire, and the balloon or the stent is released, and then the guide wire is withdrawn.

[0095] Embodiment 2

[0096] Embodiment 2 is the same as embodiment 1, except that as shown in Figures 7-9 the plane where the positioning portion 3 in contact with the inner wall of the artificial aortic valve frame is inclined at a certain angle relative to the catheter portion 1. This form also enables the positioning portion 3 to be in good contact with the stent frame strip 201 after entering the internal region of the artificial aortic valve 200 above the artificial valve leaflet 202, thereby ensuring that it can achieve the supporting and positioning effect. At the same time, since the aorta 100 has a natural curvature and is not in a straight line state, the positioning portion 3 in contact with the inner wall of the artificial aortic valve frame is inclined at a certain angle relative to the catheter portion 1, which enables the positioning portion 3 to be in good contact with the stent frame strip 201 after entering the internal region of the artificial aortic valve 200 above the artificial valve leaflet 202, and is less restricted by the catheter portion 1.

[0097] Preferably, when the plane where the positioning portion 3 in contact with the inner wall of the artificial aortic valve frame is inclined at a certain angle relative to the catheter portion 1, the included angle is less than 90 degrees and not less than 70 degrees. Within this angle range, the angle between the plane where the positioning portion 3 in contact with the inner wall of the artificial aortic valve frame and the catheter portion 1 can be pulled apart after the positioning portion 3 enters the internal region of the artificial aortic valve 200 above the artificial valve leaflet 202, and the positioning portion 3 can be in good contact with the stent frame strip 201, and is less restricted by the catheter portion 1.

[0098] In this embodiment, the curved guide-out portion 2 is located inside the circular ring where the positioning portion 3 is located.

[0099] For purposes of the description hereinafter, spatial

[0100] It is to be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments consistent with the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0101] It is to be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments consistent with the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0102] The preferred embodiments of the present application have been described above with the aid of drawing figures, and are not limited to those embodiments; instead, they will include any changes that do not constitute departures from the spirit and scope of the present application.

Claims

1. A pre-shaped sheath, characterized by, The pre-shaped sheath comprises: a catheter part, a curved leading-out part and a positioning part; the catheter part has a catheter cavity inside; the catheter part is connected to the positioning part through the curved leading-out part in a smooth transition; the curved leading-out part is provided with a leading-out hole in communication with the catheter cavity; the positioning part can be placed in the internal area of the artificial aortic valve above the artificial valve leaflet and contact the inner wall of the artificial aortic valve frame to realize the positioning of the pre-shaped sheath; the plane where the positioning part contacts the inner wall of the artificial aortic valve frame is arranged at an angle relative to the catheter part or is arranged vertically; the curved leading-out part and the positioning part can be in an elastically deformed state when subjected to external force, and automatically return to the original state after the external force is removed.

2. The pre-shaped sheath of claim 1, wherein, When the pre-shaped sheath is in an elastically deformed state, the catheter part, the curved leading-out part and the positioning part can be inserted into the blood vessel.

3. The pre-shaped sheath of claim 1, wherein, When the plane where the positioning part contacts the inner wall of the artificial aortic valve frame is arranged at an angle relative to the catheter part, the included angle is less than 90 degrees and not less than 70 degrees.

4. The pre-shaped sheath of claim 1, wherein, The projection of the curved leading-out part on the plane of the positioning part does not exceed the outermost boundary of the positioning part.

5. The pre-shaped sheath of claim 1, wherein, The positioning part is a circular ring structure with not less than 1 turn.

6. The pre-shaped sheath of claim 1, wherein, The positioning part is a circular arc structure with a central angle greater than 180 degrees.

7. A pre-shaped sheath according to claim 5 or 6, wherein, The outer diameter of the circle where the positioning part is located ranges from 1 cm to 4 cm.

8. The pre-shaped sheath of claim 1, wherein, The inner diameter of the catheter part ranges from 5F to 12F.

9. The pre-shaped sheath of claim 1, wherein, The pre-shaped sheath further comprises a visible band for developing and positioning the leading-out hole.

10. The pre-shaped sheath of claim 1, wherein, The catheter part, the curved leading-out part and the positioning part are integrally formed.

11. The pre-shaped sheath of claim 1, wherein, The catheter part, the curved leading-out part and the positioning part are made by splicing assembly.

12. A coronary angiography device, characterized by: The pre-shaped sheath according to any one of claims 1-11 and a coronary angiography catheter; the coronary angiography catheter can be inserted into the catheter cavity inside the catheter part and can be led out from the leading-out hole.

13. The coronary angiography device of claim 12, wherein, The coronary angiography device further comprises a contrast guide wire which can be inserted into the coronary angiography catheter.

14. A coronary intervention device, characterized by: The pre-shaped sheath according to any one of claims 1-11 and a coronary guide catheter; the coronary guide catheter can be inserted into the catheter cavity inside the catheter part and can be led out from the leading-out hole.

15. The coronary intervention device of claim 14, wherein the balloon is configured to be inflated to a diameter of about 1.5 mm to about 2.5 mm. The coronary intervention device further comprises a contrast guide wire and / or a guide guide wire which can be inserted into the coronary guide catheter.

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