A stent-made recyclable venous valve and method

Abstract

The present invention discloses a stent-made recyclable venous valve and method, comprising a valve area, a valve body and leaflets, wherein the valve body is located at the bottom end of the valve area, the leaflets are located at the bottom end of the valve body, a frame is provided at the top end of the valve area, a valve support body is provided inside the valve area, the frame is composed of a connecting rod, a recovery hook, a short rod, a connecting ring, a long rod and a barb, and the valve support body is composed of a long rod in the valve area, a valve skeleton and a valve mid-axis segment. Beneficial effects: It solves the two key problems of the instability of the inflow tract of the existing venous stent and the insufficient support range of the simple venous valve-type stent, and meets the three major requirements of venous reconstruction of radial support force, flexibility and stable inflow blood flow; and matches the existing venous stent system to meet the needs of patients with iliofemoral vein stenosis and occlusive lesions under various anatomical and pathological conditions.

Description

Technical Field

[0001] The present invention relates to the technical field of venous valves, and in particular to a stent-made recyclable venous valve and a method thereof. Background Art

[0002] Iliac vein stenosis and occlusive lesions, mainly including non-thrombotic iliac vein lesions, residual iliac vein stenosis after removal of acute deep vein thrombosis, and iliofemoral vein post-thrombotic syndrome, are one of the most common disease spectrums in vascular surgery. The symptoms of iliac vein stenosis and occlusive lesions are mild, such as lower limb swelling, varicose veins, and pain. In severe cases, they manifest as skin pigmentation, scleroderma, and even ulcers and other skin nutritional disorders. It not only significantly affects the quality of life of patients, but also consumes a lot of labor and medical expenses.

[0003] Traditional open surgical bypass was once the main treatment for this lesion, but open surgery is extremely traumatic and the patency rate of the bypass graft is not ideal, so it has now been abandoned clinically. With the innovation of endovascular technology and the development of interventional materials, percutaneous stent angioplasty has gradually completely replaced traditional open bypass surgery. It is not only less traumatic and has a fast recovery, but also has a much higher patency rate than traditional bypass grafts. The initial patency rate in 3 years has increased from 40% of the bypass graft to 70% of the stent angioplasty. However, the venous implant devices currently used in clinical practice are mainly implant devices of the transplanted arterial system, which have many defects and cannot meet the anatomical characteristics and hemodynamic characteristics of the iliofemoral vein.

[0004] Venous system lesions have many characteristics of their own and are very different from arterial lesions. The venous intracavitary implants previously used were either simple venous stents or simple artificial venous valves. At present, simple venous stents only have the function of expanding narrowed and occluded blood vessels, and cannot solve valve dysfunction, and cannot solve or even aggravate venous blood reflux; and the current transcatheter artificial valves are all stents with venous valves, which are suitable for patients with congenital avalvular disease and other patients who only have valvular dysfunction, but cannot solve the problem of stenosis and occlusion of long and short large veins such as long segments of the common iliac vein and the inferior vena cava, and cannot be used when the patient has already had a venous stent. At present, the main means of intracavitary treatment is the placement of venous stents, and there is no valve that matches the stent.

[0005] Iliofemoral venous endovascular stent implantation is a technique currently used in clinical practice. However, for patients with abnormal venous inflow anatomical structure and extensive venous lesions, it is often difficult to reconstruct the inflow tract using only venous stents. The inflow vein has a small diameter, and due to the limitations of the venous stent diameter and venous branch structure, it is difficult to solve this problem by simply changing the stent structure or extending the inflow tract of the venous stent. In addition, patients with venous valvular insufficiency have unobstructed venous blood return but no anti-reflux ability due to the failure to restore venous valve function, which may even lead to worsening of the condition after stent implantation.

[0006] For patients whose imaging examinations reveal venous valve insufficiency or severe damage (such as thrombotic sequelae involving the valve), autologous venous valve transplantation or artificial venous valve implantation is often performed clinically. However, simple venous valve implantation has limited effects and cannot solve the problem of long-segment stenotic and obstructive wall lesions in the veins, or the mismatch between the diameter of the stent and the diameter of the vein at the stenosis. At the same time, the existing simple valve reconstruction is not compatible with the iliofemoral vein stents. Even for some patients who have poor results after venous stent implantation and are preparing for a second venous valve reconstruction, the stenosis and occlusion of the distal vein make it impossible to implant a simple venous valve stent again.

[0007] Currently, no effective solution has been proposed for the problems in the related technologies. Summary of the invention

[0008] In view of the problems in the related art, the present invention proposes a stent-made recyclable venous valve and method to overcome the above-mentioned technical problems existing in the existing related art.

[0009] To this end, the specific technical solution adopted by the present invention is as follows:

[0010] A stent-made recyclable venous valve and method, comprising a valve area, a valve body and leaflets, wherein the valve body is located at the bottom end of the valve area, the leaflets are located at the bottom end of the valve body, a frame is provided at the top end of the valve area, a valve support body is provided inside the valve area, the frame is composed of a connecting rod, a recovery hook, a short rod, a connecting ring, a long rod and a barb, the recovery hook is fixedly connected to the top end of the connecting rod, the short rod is connected to the bottom end of the connecting rod, the long rod is matched and connected to the short rod through the connecting ring, the barb is connected to the bottom end of the long rod, the valve support body is composed of a valve area long rod, a valve skeleton and a valve central axis segment, the valve area long rod is connected to the valve skeleton, and the valve central axis segment is connected to the top end of the valve skeleton.

[0011] Furthermore, the valve body is a mesh structure, the leaflets are provided in three groups, the bottom of the leaflets forms a leaflet connection portion, and the leaflet connection portion is a tilted structure.

[0012] Furthermore, the connection point at the top end of the short rod forms a recovery point 1 that matches the connecting rod.

[0013] Furthermore, a plurality of recovery points 2 matching the short rod and the long rod are arranged on the side of the connecting ring.

[0014] Furthermore, the frame is made of self-expanding nickel-titanium alloy, and is an umbrella-shaped structure or an upper umbrella-shaped structure and a lower cylindrical structure.

[0015] Furthermore, the valve area is made of ePTFE medical polymer material, and an anticoagulant drug coating is coated on the valve area.

[0016] Furthermore, the method for inserting the stent-made recyclable venous valve comprises the following steps:

[0017] compressing the valve device along its longitudinal axis and inserting it into an intravenous delivery catheter;

[0018] The intracavitary delivery device is inserted into the venous cavity through jugular vein puncture, and the catheter is sent to the site where the venous valve is to be inserted, where contrast agent is injected for imaging to show the location and morphology of the lesion;

[0019] The valve device is delivered to run along the lumen of the vein or stent, and is delivered into the stent of the inferior vena cava or iliofemoral vein or other parts requiring treatment through a delivery catheter;

[0020] The compression valve outer sleeve is removed to allow the valve device to leave the sleeve and expand itself, the valve frame is oversized for the venous stent, and the barbs on the long rod of the frame are hooked together with the inner side of the venous stent cavity to fix the venous valve at a desired position in the stent;

[0021] Remove the delivery system along the vein cavity, press the puncture point to stop bleeding, and apply pressure to bandage the puncture point.

[0022] Furthermore, the method for recovering the stent-made recyclable venous valve comprises the following steps:

[0023] Prepare sterile intracavitary retrieval equipment, including catheter, guidewire with forceps or snare, etc.;

[0024] Insert the intracavitary retrieval device into the venous cavity through the jugular vein or a puncture point suitable for intracavitary treatment, run along the venous lumen or stent lumen, send the guide wire to the vicinity of the valve device, inject 5-10 ml of contrast agent to observe the guide wire, and make the guide wire reach the retrieval hook;

[0025] Use forceps or a snare to grab the valve retrieval hook, move it up and down to separate the barb on the frame from the stent, inject contrast medium, and deliver the frame into the catheter or snare under the guidance of a guide wire under visualization observation. The umbrella-shaped or upper umbrella-shaped plus lower cylindrical structure ensures that the valve device is compressed along the long axis and the diameter is reduced so that it can pass through the blood vessel cavity without damaging the blood vessel cavity;

[0026] Remove the delivery system along the vein cavity, press the puncture point to stop bleeding, and apply pressure to bandage the puncture point.

[0027] The beneficial effects of the present invention are: through the stent-specific recyclable venous valve, the two key problems of the existing venous stent instability and insufficient support range of the simple venous valve stent are solved, and the three major requirements of venous reconstruction of radial support force, flexibility, and stable inflow blood flow are met; and the existing venous stent system is matched to meet the needs of patients with iliac femoral vein stenosis and occlusive lesions under various anatomical and pathological conditions. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0029] Figure 1 This is one of the structural schematic diagrams of a stent-made recyclable venous valve according to an embodiment of the present invention;

[0030] Figure 2 This is the second structural schematic diagram of a stent-made recyclable venous valve according to an embodiment of the present invention.

[0031] In the figure:

[0032] 1. Valve area; 2. Valve body; 3. Leaflets; 4. Frame; 5. Valve support body; 6. Connecting rod; 7. Retrieval hook; 8. Short rod; 9. Connecting ring; 10. Long rod; 11. Barb; 12. Long rod in valve area; 13. Valve skeleton; 14. Valve mid-axis segment; 15. Leaflet connection; 16. Retrieval point one; 17. Retrieval point two. DETAILED DESCRIPTION

[0033] To further illustrate each embodiment, the present invention provides drawings, which are part of the disclosure of the present invention and are mainly used to illustrate the embodiments and can be used in conjunction with the relevant descriptions in the specification to explain the operating principles of the embodiments. With reference to these contents, ordinary technicians in the field should be able to understand other possible implementations and advantages of the present invention. The components in the figures are not drawn to scale, and similar component symbols are generally used to represent similar components.

[0034] According to an embodiment of the present invention, a stent-made retrievable venous valve and method are provided.

[0035] Embodiment 1:

[0036] like Figure 1-2As shown, a stent-made recyclable venous valve and method according to an embodiment of the present invention comprises a valve area 1, a valve body 2 and a leaflet 3, wherein the valve body 2 is located at the bottom end of the valve area 1, and the leaflet 3 is located at the bottom end of the valve body 2. A frame 4 is provided at the top of the valve area 1, and a valve support body 5 is provided inside the valve area 1. The frame 4 is composed of a connecting rod 6, a recovery hook 7, a short rod 8, a connecting ring 9, a long rod 10 and a barb 11. The recovery hook 7 is fixedly connected to the top end of the connecting rod 6, the short rod 8 is connected to the bottom end of the connecting rod 6, the long rod 10 is connected to the short rod 8 through the connecting ring 9, the barb 11 is connected to the bottom end of the long rod 10, and the valve support body 5 is composed of a valve area long rod 12, a valve skeleton 13 and a valve central axis segment 14, the valve area long rod 12 is connected to the valve skeleton 13, and the valve central axis segment 14 is connected to the top end of the valve skeleton 13.

[0037] With the help of the above technical solution, a recyclable venous valve specially made for the stent is used to solve the two key problems of the instability of the inflow tract of the existing venous stent and the insufficient support range of the simple venous valve stent. The three major requirements of venous reconstruction of radial support force, flexibility, and stable inflow blood flow are met; and the existing venous stent system is matched to meet the needs of patients with iliac femoral vein stenosis and occlusive lesions under various anatomical and pathological conditions.

[0038] Embodiment 2:

[0039] like Figure 1-2 As shown, the valve body 2 is located at the bottom end of the valve area 1, the leaflet 3 is located at the bottom end of the valve body 2, a frame 4 is provided at the top end of the valve area 1, a valve support body 5 is provided inside the valve area 1, the frame 4 is composed of a connecting rod 6, a recovery hook 7, a short rod 8, a connecting ring 9, a long rod 10 and a barb 11, the recovery hook 7 is fixedly connected to the top end of the connecting rod 6, the short rod 8 is connected to the bottom end of the connecting rod 6, the long rod 10 is connected with the short rod 8 through the connecting ring 9, and the barb 11 is connected to the valve body 2. 1 is connected to the bottom end of the long rod 10, the valve support body 5 is composed of a valve area long rod 12, a valve skeleton 13 and a valve central axis segment 14, the valve area long rod 12 is connected to the valve skeleton 13, the valve central axis segment 14 is connected to the top of the valve skeleton 13, the valve body 2 is a mesh structure, the leaflets 3 are provided with three groups, the bottom of the leaflets 3 forms a leaflet connection part 15, the leaflet connection part 15 is a tilting structure, and the connection at the top of the short rod 8 forms a recovery point 16 matching the connecting rod 6.

[0040] Embodiment three:

[0041] like Figure 1-2As shown, the valve body 2 is located at the bottom end of the valve area 1, the leaflet 3 is located at the bottom end of the valve body 2, a frame 4 is provided at the top end of the valve area 1, a valve support body 5 is provided inside the valve area 1, the frame 4 is composed of a connecting rod 6, a recovery hook 7, a short rod 8, a connecting ring 9, a long rod 10 and a barb 11, the recovery hook 7 is fixedly connected to the top end of the connecting rod 6, the short rod 8 is connected to the bottom end of the connecting rod 6, the long rod 10 is connected to the short rod 8 through the connecting ring 9, and the barb 11 is connected to the bottom end of the long rod 10 The valve support body 5 is composed of a valve area long rod 12, a valve skeleton 13 and a valve central axis segment 14. The valve area long rod 12 is connected to the valve skeleton 13, and the valve central axis segment 14 is connected to the top of the valve skeleton 13. The side of the connecting ring 9 is provided with a plurality of recovery points 17 matching the short rod 8 and the long rod 10. The frame 4 is made of self-expanding nickel-titanium alloy. The frame 4 is an umbrella-shaped structure or an upper umbrella-shaped structure plus a lower cylindrical structure. The valve area 1 is an ePTFE medical polymer material, and the valve area 1 is coated with an anticoagulant drug coating.

[0042] Embodiment 4:

[0043] The method for inserting a stent-made recyclable venous valve comprises the following steps:

[0044] compressing the valve device along its longitudinal axis and inserting it into an intravenous delivery catheter;

[0045] The intracavitary delivery device is inserted into the venous cavity through jugular vein puncture, and the catheter is sent to the site where the venous valve is to be inserted, where contrast agent is injected for imaging to show the location and morphology of the lesion;

[0046] The valve device is delivered to run along the lumen of the vein or stent, and is delivered into the stent of the inferior vena cava or iliofemoral vein or other parts requiring treatment through a delivery catheter;

[0047] The compression valve outer sleeve is removed to allow the valve device to leave the sleeve and expand itself, the valve frame is oversized for the venous stent, and the barbs on the long rod of the frame are hooked together with the inner side of the venous stent cavity to fix the venous valve at a desired position in the stent;

[0048] Remove the delivery system along the vein cavity, press the puncture point to stop bleeding, and apply pressure to bandage the puncture point.

[0049] Embodiment five:

[0050] The method for recovering a stent-made recoverable venous valve comprises the following steps:

[0051] Prepare sterile intracavitary retrieval equipment, including catheter, guidewire with forceps or snare, etc.;

[0052] Insert the intracavitary retrieval device into the venous cavity through the jugular vein or a puncture point suitable for intracavitary treatment, run along the venous lumen or stent lumen, send the guide wire to the vicinity of the valve device, inject 5-10 ml of contrast agent to observe the guide wire, and make the guide wire reach the retrieval hook;

[0053] Use forceps or a snare to grab the valve retrieval hook, move it up and down to separate the barb on the frame from the stent, inject contrast medium, and deliver the frame into the catheter or snare under the guidance of a guide wire under visualization observation. The umbrella-shaped or upper umbrella-shaped plus lower cylindrical structure ensures that the valve device is compressed along the long axis and the diameter is reduced so that it can pass through the blood vessel cavity without damaging the blood vessel cavity;

[0054] Remove the delivery system along the vein cavity, press the puncture point to stop bleeding, and apply pressure to bandage the puncture point.

[0055] To summarize, with the aid of the above-mentioned technical scheme of the present invention, a recyclable venous valve specially made for a stent is used to solve the two key problems of the instability of the inflow tract of the existing venous stent and the insufficient support range of the simple venous valve type stent, thereby meeting the three major requirements of venous reconstruction of radial support force, flexibility, and stable inflow blood flow; and matching the existing venous stent system to meet the needs of patients with iliac femoral vein stenosis and occlusive lesions under various anatomical and pathological conditions.

[0056] In the present invention, unless otherwise clearly stipulated and limited, the terms such as "installation", "setting", "connection", "fixation" and "screw-on" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be the internal connection of two elements or the interaction relationship between two elements. Unless otherwise clearly defined, ordinary technicians in this field can understand the specific meanings of the above terms in the present invention according to the specific circumstances.

[0057] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A stent-based recyclable venous valve, It is characterized in that The invention comprises a valve area (1), a valve body (2) and a leaflet (3), wherein the valve body (2) is located at the bottom end of the valve area (1), and the leaflet (3) is located at the bottom end of the valve body (2). A frame (4) is arranged at the top end of the valve area (1), and a valve support body (5) is arranged inside the valve area (1). The frame (4) is composed of a connecting rod (6), a recovery hook (7), a short rod (8), a connecting ring (9), a long rod (10) and a barb (11), wherein the recovery hook (7) is fixedly connected to the connecting rod (6). The top end of the connecting rod (6), the short rod (8) is connected to the bottom end of the connecting rod (6), the long rod (10) is connected to the short rod (8) through the connecting ring (9), the barb (11) is connected to the bottom end of the long rod (10), the valve support body (5) is composed of a valve area long rod (12), a valve frame (13) and a valve middle axis segment (14), the valve area long rod (12) is connected to the valve frame (13), and the valve middle axis segment (14) is connected to the top end of the valve frame (13); The valve body (2) is a mesh structure, the leaflets (3) are provided in three groups, the bottom of the leaflets (3) forms a leaflet connection portion (15), and the leaflet connection portion (15) is a tilted structure; The side of the connecting ring (9) is provided with a plurality of recovery points 2 (17) matching the short rod (8) and the long rod (10).

2. A stent-made recyclable venous valve according to claim 1, It is characterized in that The connection point at the top end of the short rod (8) forms a recovery point (16) that matches the connecting rod (6).

3. A stent-made recyclable venous valve according to claim 1, It is characterized in that The frame (4) is made of a self-expanding nickel-titanium alloy and is an umbrella-shaped structure or an upper umbrella-shaped structure plus a lower cylindrical structure.

4. A stent-made recyclable venous valve according to claim 1, It is characterized in that The valve area (1) is made of ePTFE medical polymer material, and an anticoagulant drug coating is coated on the valve area (1).

5. A stent-made recyclable venous valve according to claim 1, It is characterized in that The method for inserting a stent-made recyclable venous valve comprises the following steps: compressing the valve device along its longitudinal axis and inserting it into an intravenous delivery catheter; The intracavitary delivery device is inserted into the venous cavity through jugular vein puncture, and the catheter is sent to the site where the venous valve is to be inserted, where contrast agent is injected for imaging to show the location and morphology of the lesion; The valve device is delivered to run along the lumen of the vein or stent, and is delivered into the stent of the inferior vena cava or iliofemoral vein or other parts requiring treatment through a delivery catheter; The compression valve outer sleeve is removed to allow the valve device to leave the sleeve and expand itself, the valve frame is oversized for the venous stent, and the barbs on the long rod of the frame are hooked together with the inner side of the venous stent cavity to fix the venous valve in the desired position in the stent; Remove the delivery system along the vein cavity, press the puncture point to stop bleeding, and apply pressure to bandage the puncture point.

6. A stent-made recyclable venous valve according to claim 1, It is characterized in that The method for recovering a stent-made recoverable venous valve comprises the following steps: Prepare sterile intraluminal retrieval equipment, including a catheter and a guidewire with forceps or a snare; Insert the intracavitary retrieval device into the venous cavity through the jugular vein or a puncture point suitable for intracavitary treatment, run along the venous lumen or stent lumen, send the guide wire to the vicinity of the valve device, inject 5-10 ml of contrast agent to observe the guide wire, and make the guide wire reach the retrieval hook; Use forceps or a snare to capture the valve retrieval hook, move it up and down to separate the barb on the frame from the stent, inject contrast agent and, under visualization observation, deliver the frame into the catheter or snare with the help of a guide wire. The umbrella-shaped or upper umbrella-shaped plus lower cylindrical structure ensures that the valve device is compressed along the long axis and its diameter is reduced so that it can pass through the blood vessel lumen without damaging the blood vessel lumen.

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