Limited aorta covered stent

Abstract

The invention relates to the technical field of medical instruments, and provides a limited aorta covered stent which comprises a stent body, the stent body is formed by weaving metal wires and is a hollow net-shaped cylinder, net-shaped intersections of the stent body are fixed through welding, the outer wall of the stent body is connected with a covering film through a connecting assembly, and the covering film is arranged on the outer wall of the stent body. In order to cover lesions of multiple angles and quadrants, identification marks are arranged on the periphery of the covering film, the inner peripheries of the identification marks are fixedly connected with the outer periphery of the frame body, and 8 marks are arranged on the outer peripheries of the identification mark at the left end and the identification marks at the front end and the rear end. Through local film covering, on the premise that circulation of branch blood vessels is not hindered on the basis of a stent hollowed-out structure, the blood vessel crevasse is effectively blocked; extra windowing and branch stent positioning are not needed, so that the stent is simple in structure, easy to operate, free of customization and applicable to aorta and branch vascular structures of various different physiological structures, and flexibility and convenience of the stent are greatly improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a limited aortic stent graft. Background Art

[0002] In recent years, aortic stent grafts have been widely used in the treatment of lesions such as aneurysms and arterial dissections of the descending and abdominal aorta, and have achieved good mid- and long-term results. However, since the implantation of the stent needs to ensure that the blood supply of the main branch vessels on the aorta is not blocked, aortic dissections and aortic aneurysms involving the branch arteries on the aortic arch (brachiocephalic trunk, left common carotid artery, left subclavian artery) and abdominal visceral arteries (celiac trunk, superior mesenteric artery, bilateral renal arteries) are difficult to treat with minimally invasive endovascular therapy. Although there are currently technologies such as in situ / pre-fenestrated, parallel stents, and branched stents, there are disadvantages such as complex operation, customization, and uncertain long-term efficacy.

[0003] In situ fenestration technology is to implant the traditional covered stent graft into the aorta without pre-opening the window, then locate the opening of the target artery, and open the window at the branch vessel by puncture with a puncture needle or laser perforation, or balloon expansion of the covered stent. The biggest disadvantage of this method is that the covered stent first covers the branch vessel, and then opens the window, which takes time and can easily cause severe ischemia in the branch vessel.

[0004] The pre-window and branch stent technology is to reserve the branch vessel opening aperture or branch stent on the coated stent in advance. However, because the physiological signs of the human body are different, the branch stent also has the problem of insufficient release space and the need for customization, so its scope of application is relatively limited.

[0005] Therefore, a new type of intra-aortic branched covered stent is urgently needed to solve the above problems. Summary of the invention

[0006] In view of the deficiencies in the prior art, the present invention provides a limited aortic covered stent, which solves the problem in the prior art that the aortic stent needs to reserve branch vessel opening apertures or branch stents on the covered stent in advance, and the problem that the application scope of the stent is relatively limited due to different physiological signs of the human body.

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] A limited aortic covered stent comprises a frame, which is woven with metal wires and has a shape of a hollow mesh cylinder. The mesh intersections of the frame are fixed by welding. The outer wall of the frame is connected to a film through a connecting component, so as to cover lesions at multiple angles and quadrants. Identification marks are arranged around the film, and the inner periphery of the identification marks is fixedly connected to the outer periphery of the frame. The outer periphery of the identification mark at the left end and the identification marks at the front and rear ends is marked with a mark of the number "8", and the outer periphery of the identification mark at the right end is marked with a mark of the number "0", so that medical staff can determine the boundary of the film through imaging equipment and adjust the angle of the stent to face the rupture of the blood vessel.

[0009] Preferably, the connecting assembly includes a connecting head 1 fixedly connected to the inner circumference of the coating, the connecting head is set on the metal wire part of the frame, and a fixing hoop is provided on the outer wall, the middle end of the fixing hoop is fixedly connected with a positioning part, the positioning part is located inside the opening of the connecting head 1, both ends of the fixing hoop are fixedly connected with a clamping joint, and grooves are provided on both sides of the outer wall of the connecting head 1, and the clamping joint is clamped inside the groove.

[0010] Preferably, the connecting assembly also includes a second connecting head fixedly connected to the inner circumference of the coating, the second connecting head is sleeved on the metal wire portion of the frame, both ends of the second connecting head are provided with limiting portions, the limiting portions are fixedly connected to the metal wire portion of the frame, and the inner circumference of the second connecting head is fixedly connected with a force-applying portion.

[0011] Preferably, the metal wire is prepared by using any one of high-strength shape memory alloys including nickel-titanium alloy or high-strength metals including cobalt-chromium alloy and stainless steel as raw material.

[0012] Preferably, the coating is made of either PTFE or polyester as a raw material.

[0013] Preferably, the inner circumference of the coating is 1 / 4 of the circumference of the cross section of the frame.

[0014] A method for using a limited aortic stent graft comprises the following steps:

[0015] Step 1: The frame remains in a contracted state, and the film remains folded;

[0016] Step 2: Work with auxiliary equipment equipped with mounting brackets, such as balloons, sleeves, etc.;

[0017] Step 3: Insert the stent into the patient's aorta and confirm the direction of the stent with the help of imaging equipment until it moves to the patient's site. The medical staff uses imaging equipment to determine the coating boundary and identification mark, adjust the angle of the stent so that it faces the rupture of the blood vessel, and use appropriate expansion methods to expand the stent;

[0018] Step 4: The membrane is unfolded as the frame expands and is attached to the ruptured blood vessel.

[0019] Preferably, in step one, the folding state includes two states: single-fold folding and multi-fold folding.

[0020] Preferably, the expansion method in step 3 is selected from:

[0021] For the frame made of high-strength shape memory alloy, the characteristics of the memory alloy are used to make the frame expand on its own;

[0022] For a frame made of high-strength metal, a balloon is used to inflate the frame to expand it.

[0023] Preferably, the determination of the bracket angle in step 4 is based on:

[0024] When you see two "8s", the lamination center is facing the developing device;

[0025] When an "8" is seen, the center of the coating is located to the left of the centerline of the stent's long axis;

[0026] When "0" is seen, the center of the coating is located to the right of the centerline of the stent's long axis;

[0027] When no mark is visible, the center of the film is facing away from the developer.

[0028] The present invention provides a limited aortic stent graft, which has the following beneficial effects:

[0029] The present invention uses local coating to effectively block the rupture of blood vessels based on the premise that the hollow structure of the stent does not hinder the circulation of branch blood vessels. There is no need for additional window opening and positioning of branch stents, so the stent structure is simple and easy to operate. It does not need to be customized and can be applied to a variety of aortic and branch blood vessel structures with different physiological structures, greatly improving the flexibility and convenience of the stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 A perspective view of the present invention;

[0031] Figure 2 It is a left structural schematic diagram of the present invention;

[0032] Figure 3 It is a schematic diagram of the right structure of the present invention.

[0033] Figure 4 The structure diagram of the stent contraction of the present invention is shown in FIG. Figure 1 ;

[0034] Figure 5 The connection structure of the stent and the coating of the present invention is shown in FIG. Figure 1 ;

[0035] Figure 6 It is a structural schematic diagram of a connector 1 of the present invention;

[0036] Figure 7 The structure diagram of the stent contraction of the present invention is shown in FIG. Figure 2 ;

[0037] Figure 8 The connection structure of the stent and the coating of the present invention is shown in FIG. Figure 2 ;

[0038] Fig. 9 It is a structural schematic diagram of the connector 2 of the present invention;

[0039] Fig.10 Schematic diagram of the wavy bare bracket structure.

[0040] Among them, 1. frame; 2. coating; 3. connector 1; 4. fixing hoop; 5. positioning part; 6. clamping joint; 7. connector 2; 8. force-applying part; 9. limiting part; 10. identification mark. DETAILED DESCRIPTION

[0041] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0042] Embodiment 1:

[0043] As one aspect of this application, please see the attached Figure 1 -Attached Figure 6The embodiment of the present invention provides a limited aortic covered stent, including a frame 1, which is woven by metal wires and has a hollow mesh cylinder shape, and the mesh intersection of the frame 1 is fixed by welding, and a connector 3 fixedly connected to the inner periphery of the covering 2 is sleeved on the metal wire part of the frame 1, and the outer wall is provided with a fixing hoop 4, and the middle end of the fixing hoop 4 is fixedly connected with a positioning part 5, and the positioning part 5 is located inside the opening of the connecting head 3, and both ends of the fixing hoop 4 are fixedly connected with a clamping joint 6, and both sides of the outer wall of the connecting head 3 are provided with grooves, and the clamping joint 6 is clamped in Inside the groove, the coating 2 covers lesions at multiple angles and quadrants. Identification marks 10 are set around the coating 2. The inner periphery of the identification mark 10 is fixedly connected to the outer periphery of the frame 1. The outer periphery of the left identification mark 10 and the front and rear identification marks 10 is set with a mark of the number "8", and the outer periphery of the right identification mark 10 is set with a mark of the number "0", so that medical staff can determine the boundary of the coating 2 through imaging equipment and adjust the angle of the stent to face the rupture of the blood vessel. The identification mark 10 will not fold with the contraction of the frame 1 to maintain visualization;

[0044] Specifically, the coating 2 has multiple fixing structures, which correspond to some metal wires on the frame 1 corresponding to the coating 2 area, so that the coating 2 can be folded and unfolded following the contraction and expansion of the frame 1. When fixing the coating 2 to the frame 1, the connector 3 is clamped on the metal wire part, and then aligned with the opening of the connector 3, the fixing hoop 4 is put on the outer wall of the connector 3, and the clamping joint 6 is clamped inside the groove, and the fixing hoop 4 is pressed and fixed along the position of the clamping joint 6.

[0045] The metal wire is made of any one of high-strength shape memory alloys including nickel-titanium alloy as a raw material to achieve a balloon-free self-expansion recovery method to expand the patient's aorta.

[0046] The coating 2 is made of PTFE or polyester as a raw material, and the inner circumference of the coating 2 is 1 / 4 of the circumference of the cross section of the frame 1 .

[0047] Based on the above-mentioned limited aortic stent graft, as another aspect of the present application, a method for using the limited aortic stent graft comprises the following steps:

[0048] Step 1: The frame 1 is kept in a contracted state, and the film 2 is kept in a single fold;

[0049] Step 2: Work with auxiliary equipment equipped with mounting brackets, such as balloons, sleeves, etc.;

[0050] Step 3: insert the stent into the patient's aorta, and confirm the direction of the stent with the help of imaging equipment until it moves to the patient's site. The medical staff uses the imaging equipment to determine the boundary of the coating 2 and the identification mark 10, adjust the angle of the stent so that it faces the rupture of the blood vessel, and use a suitable expansion method to expand the frame 1. The expansion method is selected as follows: for the frame 1 made of high-strength shape memory alloy, the characteristics of the memory alloy are used to make the frame 1 expand automatically;

[0051] The bracket angle is determined based on:

[0052] When two "8"s are seen, the center of the film 2 is facing the developing device;

[0053] When an "8" is seen, the center of the coating 2 is located to the left of the centerline of the stent's long axis;

[0054] When "0" is seen, the center of the coating 2 is located to the right of the centerline of the stent's long axis;

[0055] When no mark is visible, the center of the film 2 faces away from the developing device.

[0056] Step 4: The membrane 2 is unfolded along with the expansion of the frame 1, and the membrane 2 is attached to the rupture of the blood vessel.

[0057] Embodiment 2:

[0058] As one aspect of this application, please see the attached Figure 1 , Attachment Figure 2 , Attachment Figure 3 , Attachment Figure 7 , Attachment Figure 8 and attached Fig. 9 The embodiment of the present invention provides a limited aortic covered stent, including a frame 1, which is woven by metal wires and is shaped like a hollow mesh cylinder, and the mesh intersection of the frame 1 is fixed by welding, and the connector 2 7 fixedly connected to the inner periphery of the covering 2 is sleeved on the metal wire part of the frame 1, and both ends of the connector 2 7 are provided with a limiting part 9, and the limiting part 9 is fixedly connected to the metal wire part of the frame 1, and the inner periphery of the connector 2 7 is fixedly connected with a force-applying part 8, and the covering 2 covers multiple angles, such as For the limited lesions, the coating 2 is provided with identification marks 10 around, the inner periphery of the identification marks 10 is fixedly connected to the outer periphery of the frame 1, the outer periphery of the left end identification mark 10 and the front and rear end identification marks 10 is provided with a mark of the number "8", and the outer periphery of the right end identification mark 10 is provided with a mark of the number "0", so that the medical staff can determine the boundary of the coating 2 through the imaging equipment and adjust the angle of the stent to face the rupture of the blood vessel, wherein the identification mark 10 will not be folded with the contraction of the frame 1 to maintain visualization;

[0059] Specifically, the coating 2 has multiple fixing structures, which correspond to some metal wires in the corresponding coating 2 areas on the frame 1, so that the coating 2 can be folded and unfolded following the contraction and expansion of the frame 1. When fixing the coating 2 to the frame 1, the connector 2 is placed on the metal wire part and is positioned between the two limiting parts 9 for limiting. Then, the force applying part 8 is used as the force applying point to close the opening of the connector 7, and the metal wire is clamped to fix the connector 7.

[0060] The metal wire is made of any one of high-strength metals including cobalt-chromium alloy and stainless steel as a raw material so as to maintain the shape after being expanded by a balloon.

[0061] The coating 2 is made of PTFE or polyester as a raw material, and the inner circumference of the coating 2 is 1 / 4 of the circumference of the cross section of the frame 1 .

[0062] Based on the above-mentioned limited aortic stent graft, as another aspect of the present application, a method for using the limited aortic stent graft comprises the following steps:

[0063] Step 1: the frame 1 is kept in a contracted state, and the film 2 is kept in a multi-fold folded state;

[0064] Step 2: Work with auxiliary equipment equipped with mounting brackets, such as balloons, sleeves, etc.;

[0065] Step 3: Insert the stent into the patient's aorta and confirm the direction of the stent with the assistance of imaging equipment until it moves to the patient's site. Medical staff use imaging equipment to determine the boundary of the coating 2 and the identification mark 10, adjust the angle of the stent so that it faces the rupture of the blood vessel, and use a suitable expansion method to expand the frame 1. The expansion method selected is: for the frame 1 made of high-strength metal, use balloon inflation to expand the frame 1.

[0066] The bracket angle is determined based on:

[0067] When two "8"s are seen, the center of the film 2 is facing the developing device;

[0068] When an "8" is seen, the center of the coating 2 is located to the left of the centerline of the stent's long axis;

[0069] When "0" is seen, the center of the coating 2 is located to the right of the centerline of the stent's long axis;

[0070] When no mark is visible, the center of the film 2 faces away from the developing device.

[0071] Step 4: The membrane 2 is unfolded along with the expansion of the frame 1, and the membrane 2 is attached to the rupture of the blood vessel.

[0072] Since most of the local ruptures of the aorta are transverse, the coating 2 in both embodiments of the present invention is preferably of a rectangular structure, which can meet the function of sealing and repairing most transverse ruptures.

[0073] In addition, although the two embodiments of the present invention use a mesh-structured bare stent as an example to illustrate the principle and spirit of the present invention, the connecting assembly provided by the present invention is also applicable to other related bare stent structures in the field, including a wave-structured bare stent.

[0074] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A limited aortic stent graft, characterized in that: The invention comprises a frame (1), wherein the frame (1) is woven from metal wires and is in the shape of a hollow mesh cylinder, and the mesh intersection of the frame (1) is fixed by welding. The outer wall of the frame (1) is connected to a coating (2) through a connecting assembly, so as to cover lesions at multiple angles and quadrants. The coating (2) is provided with identification marks (10) on all sides, and the inner periphery of the identification mark (10) is fixedly connected to the outer periphery of the frame (1). The outer periphery of the identification mark (10) at the left end and the identification marks (10) at the front and rear ends is provided with a mark with the number "8", and the outer periphery of the identification mark (10) at the right end is provided with a mark with the number "0", so that medical personnel can determine the boundary of the coating (2) through imaging equipment and adjust the angle of the stent to face the rupture of the blood vessel.

2. The limited aortic stent graft according to claim 1, characterized in that: The connection assembly comprises a connection head (3) fixedly connected to the inner periphery of the coating (2); the connection head (3) is sleeved on the metal wire portion of the frame (1), and a fixing hoop (4) is provided on the outer wall; a positioning portion (5) is fixedly connected to the middle end of the fixing hoop (4); the positioning portion (5) is located inside the opening of the connection head (3); both ends of the fixing hoop (4) are fixedly connected to a clamping joint (6); grooves are provided on both sides of the outer wall of the connection head (3), and the clamping joint (6) is clamped inside the grooves.

3. The limited aortic stent graft according to claim 1, characterized in that: The connection assembly also includes a second connection head (7) fixedly connected to the inner periphery of the coating (2), the second connection head (7) being sleeved on the metal wire portion of the frame (1), and both ends of the second connection head (7) are provided with a limiting portion (9), the limiting portion (9) being fixedly connected to the metal wire portion of the frame (1), and the inner periphery of the second connection head (7) is fixedly connected with a force-applying portion (8).

4. The limited aortic stent graft according to claim 1, characterized in that: The metal wire is prepared by using any one of high-strength shape memory alloys including nickel-titanium alloy or high-strength metals including cobalt-chromium alloy and stainless steel as raw material.

5. The limited aortic stent graft according to claim 1, characterized in that: The coating (2) is prepared by using either PTFE or polyester as a raw material.

6. The limited aortic stent graft according to claim 1, characterized in that: The inner circumference length of the coating (2) is 1 / 4 of the circumference length of the cross section of the frame (1).

7. A method for using a limited aortic stent graft, using the limited aortic stent graft according to any one of claims 1 to 6, characterized in that: The following steps are involved: Step 1: shrink the frame (1) and fold the film (2) together; Step 2: Work with auxiliary equipment equipped with mounting brackets, such as balloons, sleeves, etc.; Step 3: insert the stent into the patient's aorta and confirm the direction of the stent with the help of imaging equipment until it moves to the patient's site. The medical staff uses the imaging equipment to determine the boundary of the coating (2) and the identification mark (10), adjust the angle of the stent so that it faces the rupture of the blood vessel, and use a suitable expansion method to expand the stent (1); Step 4: The membrane (2) is unfolded along with the expansion of the frame (1), and the membrane (2) is attached to the rupture of the blood vessel.

8. The method for using a limited aortic stent graft according to claim 7, characterized in that: In the step 1, the folding state includes two states: single-fold folding and multi-fold folding.

9. The method for using a limited aortic stent graft according to claim 7, characterized in that: The expansion method in step 3 is selected as follows: For a frame (1) made of a high-strength shape memory alloy, the characteristics of the shape memory alloy are utilized to enable the frame (1) to expand on its own; For a frame (1) made of high-strength metal, a balloon is inflated to expand the frame (1).

10. The method for using a limited aortic stent graft according to claim 7, characterized in that: The determination of the bracket angle in step 4 is based on: When two "8"s are seen, the center of the film (2) is facing the developing device; When an "8" is seen, the center of the coating (2) is located on the left side of the centerline of the long axis of the stent; When "0" is seen, the center of the coating (2) is located to the right of the centerline of the stent's long axis; When no mark is visible, the center of the coating (2) faces away from the developing device.

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