CN107496056B - Aortic valve stent delivery system and aortic valve system - Google Patents
Aortic valve stent delivery system and aortic valve system Download PDFInfo
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- CN107496056B CN107496056B CN201710810973.5A CN201710810973A CN107496056B CN 107496056 B CN107496056 B CN 107496056B CN 201710810973 A CN201710810973 A CN 201710810973A CN 107496056 B CN107496056 B CN 107496056B
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- 210000001765 aortic valve Anatomy 0.000 title claims abstract description 73
- 230000002093 peripheral effect Effects 0.000 claims abstract description 9
- 238000004873 anchoring Methods 0.000 claims description 24
- 239000000463 material Substances 0.000 claims description 12
- 238000007667 floating Methods 0.000 claims description 3
- 238000013461 design Methods 0.000 abstract description 8
- 238000000465 moulding Methods 0.000 abstract description 4
- 238000010992 reflux Methods 0.000 abstract description 4
- 230000002792 vascular Effects 0.000 abstract description 2
- 230000010339 dilation Effects 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- 238000007789 sealing Methods 0.000 description 6
- 206010002906 aortic stenosis Diseases 0.000 description 5
- 208000003017 Aortic Valve Stenosis Diseases 0.000 description 4
- 229920000642 polymer Polymers 0.000 description 4
- 210000005240 left ventricle Anatomy 0.000 description 3
- 230000002861 ventricular Effects 0.000 description 3
- 239000004677 Nylon Substances 0.000 description 2
- 210000000709 aorta Anatomy 0.000 description 2
- 201000002064 aortic valve insufficiency Diseases 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 210000003709 heart valve Anatomy 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
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- 206010002915 Aortic valve incompetence Diseases 0.000 description 1
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- 239000002250 absorbent Substances 0.000 description 1
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- 210000003291 sinus of valsalva Anatomy 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0065—Additional features; Implant or prostheses properties not otherwise provided for telescopic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0069—Sealing means
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention relates to an aortic valve stent, which comprises a stent and a prosthetic valve connected to the stent, wherein the stent is a double-layer stent, and particularly comprises a balloon expandable stent and a self-expanding stent, wherein the prosthetic valve is connected to the self-expanding stent, and when the stent is conveyed, the self-expanding stent is positioned at the inner periphery of the balloon expandable stent and tightly abuts against the balloon expandable stent in the peripheral direction; the balloon expandable stent is tightly abutted against the aortic valve of a human body to the periphery, and the stent balloon is expanded to the arterial valve of the stent by the balloon. The invention adopts the double-layer design of the bracket with the artificial valve, ensures the full expansion and full fixation of the aortic valve, ensures the molding and the area in the bracket, simultaneously ensures the compliance and the supporting force of the bracket, reduces the occurrence of paravalvular leakage and central reflux, does not expand the diameter of a sheath tube, and avoids the risk of vascular complications.
Description
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to an aortic valve system and a stent delivery system thereof.
Background
With the development trend of the aging society in China, the incidence rate of senile valve degenerative disease is continuously increased, wherein aortic valve stenosis is gradually the most common valve heart disease of the crowd. Surgical aortic valve replacement has been the only treatment for patients with severe aortic valve stenosis, but elderly patients often contraindicated for advanced age, weak constitution, severe lesions or complicated with other diseases. Statistics in developed countries indicate that about 1/3 of patients with severe aortic valve stenosis are not able to receive traditional surgical open chest surgery due to high surgical risk or contraindications. For patients with high risk or contraindicated cardiac surgery, transcatheter aortic valve implantation is now available as an effective treatment. The technology sends the artificial heart valve to the aortic valve area to open through the femoral artery to send the interventional catheter, thereby completing the implantation of the artificial valve and recovering the valve function. The operation does not need to open the chest, so the wound is small and the postoperative recovery is quick. However, the operation of the interventional operation is very complex, and the technical problems of high complications in the perioperative period and the like are also faced in clinical practice.
Aortic valve systems typically include a stent and a prosthetic valve attached to the stent. The stents of aortic valve systems currently in the market and in clinical studies are classified into self-expanding stents, balloon-expandable stents, and mechanically-expandable stents. The self-expanding stent has the advantages of small pressure difference across the valve after the valve is released, low occurrence rate of transfer to blockage and the like, and has the defects of poor coaxiality, poor expansion, difficult positioning, easy slipping and the like during release, thereby causing problems of paravalvular leakage, central leakage, conduction blockage, valve slipping and the like; the balloon expandable stent and the mechanical expandable stent are mainly difficult to position, and have the problems of small valve opening area, large valve-crossing pressure difference and the like after release. All valve stents are only suitable for aortic stenosis patients due to the fixation problem, and are not suitable for aortic insufficiency patients.
In the prior art, researchers have made various efforts to make improvements in aortic valve stents in an attempt to solve one or more of the above problems, however, none of the effects are ideal. For example, patent US7445631 discloses an aortic valve braided stent which is designed to provide some perivalvular leakage prevention by attaching a mesh to the bottom of the stent to secure a skirt made of polymer or pericardial material, but with a larger loading sheath, thereby limiting its application. Patent EP1980220, for example, discloses a transapically delivered aortic valve stent that achieves a reduction in paravalvular leakage by clamping the original calcified valve, but nevertheless, the design does not improve paravalvular leakage when the patient's original calcified valve is irregular or not closed in its gap; moreover, clinical effects also show that the design can lead to the increase of the pressure difference across the valve of the patient, and influence the curative effect. Patent CN201120022195 discloses an ascending aorta intra-luminal isolation stent with a filled-type fixing balloon, which is sewn or adhered with the filled-type fixing balloon on the outer side of the covered straight stent, and a water-absorbing material is filled in the balloon, which can absorb water and expand in the blood vessel, thereby playing a role of fixing the stent and preventing displacement. The water-absorbent materials can also be used in a solution to prevent paravalvular leakage, but have the disadvantage of not controlling the rate of water absorption and of presenting a great risk to the patient as soon as they leak outside the capsule. Patent WO2013012801 describes an interventional heart valve stent with a polymeric sealing unit fixed inside or outside the bottom mesh in order to be placed in the space between the stent and the tissue annulus after the stent has been expanded and released. The problems of the bracket are mainly that: the thickness of the high polymer sealing unit has a bottleneck, the loading is difficult due to the fact that the high polymer sealing unit is too thick, the shape restoring force is very limited due to the fact that the high polymer sealing unit is too thin, and the expected effect cannot be achieved; the adopted sealing unit has insufficient compliance, so that the concave part of an irregular tissue ring cannot be automatically filled, and the convex part of the tissue ring can press the valve frame through the sealing unit, thereby influencing the closing form and the hemodynamics of the valve and even causing more serious perivalvular leakage.
In summary, although various efforts have been made, the problems of positioning and perivalvular leakage of existing aortic valve stents have not been well resolved. Moreover, all the existing valve stents can only be suitable for patients with aortic valve stenosis due to the positioning problem, and are not suitable for patients with aortic valve insufficiency.
Disclosure of Invention
The invention aims to solve the positioning problem of the existing aortic valve stent and provides an improved aortic valve stent delivery system and an aortic valve system comprising the same.
In order to solve the technical problems, the invention adopts a technical scheme that:
The aortic valve stent delivery system comprises a push release device for delivering the aortic valve stent, in particular, the aortic valve stent delivery system further comprises a special-shaped balloon catheter arranged at the front end of the push release device, the special-shaped balloon catheter comprises a balloon, the balloon comprises a columnar connecting part and a balloon expanding part communicated with the columnar connecting part, the columnar connecting part is connected with the front end of the push release device, and the balloon is designed to: after the balloon expanding part is expanded, a positioning surface is formed on one side close to the columnar connecting part, and when the aortic valve stent delivery system is used, the balloon expanding part of the balloon is positioned in a left ventricle outflow channel and is tightly attached to the bottom of the aortic valve of a human body through the positioning surface, so that the functions of positioning and reducing and/or preventing perivalvular leakage are achieved. According to the invention, the locating surface may be substantially planar or substantially arcuate or otherwise. As a specific and preferred aspect of the present invention, the positioning surface is substantially planar. The plane may be a straight plane or an inclined plane.
According to a particular aspect of the invention, the positioning surface is substantially perpendicular to the axis of the cylindrical connection. According to still another specific aspect of the present invention, the positioning surface is an annular surface surrounding the outer periphery of the front end of the columnar connecting portion.
In a specific embodiment according to the invention, the balloon assumes a mushroom-like shape after being inflated. The balloon dilation presents an apple-like shape.
According to a preferred aspect of the invention, the columnar connection of the balloon is semi-compliant and may be made of a semi-compliant material; the balloon expandable portion is compliant and may be made of a compliant material. The compliance (compliance) refers to the corresponding change in the shape or volume of the balloon per one increase in the balloon inflation, and is an indicator of the balloon stretching force. The material of the semi-compliant balloon is typically nylon or the like, and the material of the compliant balloon (21) is typically rubber, for example.
The invention also provides an aortic valve system which comprises a bracket, a prosthetic valve connected to the bracket and the aortic valve bracket conveying system.
Preferably, the stent is a double-layer stent, and specifically comprises a balloon expandable stent and a self-expanding stent, wherein the artificial valve is connected to the self-expanding stent, and when the stent is conveyed, the self-expanding stent is positioned at the inner periphery of the balloon expandable stent and tightly abuts against the balloon expandable stent towards the outer periphery; the balloon expandable stent is peripherally tightened against the aortic valve of the human body. The double-layer stent design ensures the full expansion and full fixation of the aortic valve, ensures the molding and the area in the stent, and reduces the occurrence of perivalvular leakage and central reflux.
Further preferably, an anchoring structure for improving the bonding force between the self-expanding stent and the balloon-expandable stent is formed between the front end portion of the self-expanding stent and the balloon-expandable stent. The design of the anchoring structure ensures that the stent is well fixed and prevents paravalvular leakage.
The specific arrangement of the anchoring structures according to the invention may be varied. For example, the anchoring structure may include an anchoring portion at the front end of the self-expanding stent that is form-fitted with the balloon-expandable stent, which may enhance the coupling force therebetween. Or the anchoring structure can comprise a first matching part formed on the outer peripheral surface of the front end of the self-expanding stent and a second matching part formed on the inner peripheral surface of the balloon expanding stent, and the first matching part and the second matching part are matched and fixed. The first matching part and the second matching part are matched in a floating point matching mode, a tooth matching mode or a thread matching mode. Or the anchoring structure may be a combination of the two.
According to a specific and preferred aspect of the present invention, the balloon expandable stent has a length less than that of a self-expanding stent. When the stent delivery is completed, the balloon expandable stent is positioned at the outer periphery of the front end of the self-expanding stent. Further, the balloon expandable stent has a length of about 1/6 to 1/3 of the self-expanding stent.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
the aortic valve stent delivery system of the invention adopts the special-shaped balloon which is added at the front end of the pushing and releasing device, when in use, the balloon expansion part of the special-shaped balloon is released after the valve is approximately positioned and expanded, so that the special-shaped balloon is anchored in the left ventricular outflow tract, the whole delivery system is retracted, so that the balloon is anchored under the aortic valve, at the moment, the stent is firmly positioned, the coaxiality is good, and the stent can help to reduce or prevent the perivalve leakage due to the firm positioning and the good coaxiality. In addition, the aortic valve stent delivery system is simple to set, and the special-shaped balloon catheter is added on the basis of the original delivery system.
Drawings
FIG. 1 is a schematic view, partially in section, of an aortic valve system according to the invention;
FIG. 2 is a schematic cross-sectional view at A-A of FIG. 1;
FIG. 3 is a schematic cross-sectional view at B-B in FIG. 1;
FIG. 4 shows a schematic longitudinal cross-sectional view of a form one shaped balloon after inflation;
FIG. 5 shows a schematic longitudinal cross-sectional view of a form two shaped balloon after inflation;
FIGS. 6a-6f illustrate stent delivery using the aortic valve stent delivery system of the present invention, wherein FIG. 6a illustrates the delivery of the stent delivery system and stent delivery along a guidewire to a designated location; FIG. 6b shows a state in which the positioning surface of the balloon-expanding portion is closely adhered to the bottom surface of the sinus bottom of the aortic valve of the human body after the balloon-expanding portion is exposed and expanded and retracted; FIG. 6c shows a schematic view of the ballstent after it has been released; FIG. 6d shows a schematic view of the balloon being depressurized and the self-expanding stent being delivered to a designated location; FIG. 6e shows a schematic view of the self-expanding stent after being released; FIG. 6f shows the stent in position at the aortic valve of the human body after the delivery system has been withdrawn;
FIG. 7 is a schematic view of the loading position of the balloon expandable stent and the self-expanding stent;
FIG. 8 is a schematic illustration of the deployment process of a balloon expandable stent;
fig. 9 is an enlarged view of the deployment process of the balloon expandable stent.
Wherein: 1. a prosthetic valve; 2. a profiled balloon catheter; 21. a balloon; 211. a columnar connection portion; 212. a balloon dilation portion; 213. a positioning surface; 5. an aortic valve; 51. the bottom of the aortic valve; 3. a balloon expandable stent; 4. a self-expanding stent; 52. an aortic valve; 6. an inner sheath; 7. an outer sheath; 8. a guide wire.
Detailed Description
The technical scheme of the invention is further described below with reference to the accompanying drawings and the specific embodiments.
As shown in fig. 1, the present invention relates to an aortic valve system comprising a stent, a prosthetic valve 1 attached to the stent, and an aortic valve stent delivery system.
The aortic valve stent delivery system comprises a push release device for delivering the stent, and a special-shaped balloon catheter 2 arranged at the front end of the push release device.
The special-shaped balloon catheter 2 includes a balloon 21, as shown in fig. 4 and 5, the balloon 21 has a columnar connection portion 211 and a balloon dilatation portion 212 communicating with the columnar connection portion 211, the columnar connection portion 211 is connected with the front end of the push release device, and the balloon 21 is designed to: after the balloon expansion part 212 is expanded, a positioning surface 213 is formed on one side close to the columnar connecting part 211, and when the aortic valve stent delivery system is used, the balloon expansion part 212 of the balloon 21 is positioned in a left ventricle outflow tract and is tightly attached to the bottom 51 of the aortic valve 5 of the human body through the positioning surface 213, so that the functions of positioning and reducing and/or preventing perivalvular leakage are achieved.
The locating surface 213 may be generally planar or generally arcuate in shape or other forms in accordance with the present invention. In this embodiment, the positioning surface 213 is substantially planar, wherein the planar surface may be a straight plane or an inclined plane. According to the present invention, the positioning surface 213 is substantially perpendicular to the axis of the columnar connection portion 211, and the positioning surface 213 is an annular surface surrounding the outer periphery of the front end of the columnar connection portion 211. As shown in fig. 4, the balloon 21 assumes a mushroom-like shape after being inflated. As shown in fig. 5, balloon dilation 212 is apple-like in shape.
According to the present invention, the columnar connection 211 of the balloon 21 is semi-compliant and may be made of a semi-compliant material; balloon dilation portion 212 is compliant and may be made of a compliant material. The compliance (compliance) refers to the corresponding change in the shape or volume of the balloon 21 per one increase in the inflation of the balloon 21, and is an indicator of the tensile force of the balloon 21. The material of the semi-compliant balloon 21 is typically nylon or the like, and the material of the compliant balloon 21 is typically rubber, for example.
As shown in fig. 1 to 3 and fig. 6a to 6f, the stent is a double-layered stent, specifically comprises a balloon expandable stent 3 and a self-expandable stent 4, wherein the prosthetic valve 1 is connected to the self-expandable stent 4, and when the stent delivery is completed, the self-expandable stent 4 is positioned at the inner periphery of the balloon expandable stent 3 and tightly abuts against the balloon expandable stent 3 at the outer periphery; the balloon expandable stent 3 is peripherally tightened against the aortic valve 52 of the human body. The double-layer stent design ensures the full expansion and full fixation of the aortic valve 5, ensures the molding and the area in the stent, and reduces the occurrence of perivalvular leakage and central reflux.
Further preferably, an anchoring structure that improves the bonding force between the self-expanding stent 4 and the balloon-expandable stent 3 is formed between the front end portion of the self-expanding stent 4 and the balloon-expandable stent 3. The design of the anchoring structure ensures that the stent is well fixed and prevents paravalvular leakage. The specific arrangement of the anchoring structures may vary. For example, the anchoring structure may include an anchoring portion at the front end of the self-expanding stent 4, which is form-fitted with the balloon-expandable stent 3, so that the coupling force of the two can be enhanced. Alternatively, the anchoring structure may include a first fitting portion formed on the outer peripheral surface of the front end of the self-expanding stent 4, and a second fitting portion formed on the inner peripheral surface of the balloon-expandable stent 3, the first fitting portion being fitted and fixed with the second fitting portion. The first matching part and the second matching part are matched in a floating point matching mode, a tooth matching mode or a thread matching mode. Or the anchoring structure may be a combination of the two.
In this embodiment, the balloon expandable stent 3 has a length less than the self-expanding stent 4. When the stent delivery is completed, the balloon expandable stent 3 is positioned at the outer periphery of the front end of the self-expanding stent 4. Further, the balloon expandable stent 3 has a length of about 1/6 to 1/3 of the self-expanding stent 4.
In the present invention, the push release device is not essential to the protection of the present invention, and the push release device commonly used in the prior art can be used. The rest of the shaped balloon catheter 2 other than the balloon 21 is not essential to the protection of the present invention, and the rest of balloon catheters commonly used in the prior art, such as catheters, etc., may be used. The method of using the push release device, the method of using the balloon catheter, and the method of expanding the balloon 21 may be known methods.
As shown in fig. 1 and 7, the loaded aortic valve system of the present invention has the following structure: the self-expanding stent 4 is positioned in a lumen between an inner sheath 6 and an outer sheath 7 of the push release device, the special-shaped balloon catheter 2 is loaded at the front end of the inner sheath 6, the balloon expanding stent 3 is sleeved on a columnar connecting part 211 of the special-shaped balloon catheter 2, and the special-shaped balloon catheter 2 and the balloon expanding stent 3 are both positioned in the outer sheath 7.
In use, the loaded aortic valve system is first introduced along the guide wire 8 to the aortic valve 5, specifically, the balloon dilation 212 of the balloon 21 is made to reach the left ventricular outflow tract, and the balloon dilation stent 3 is positioned approximately at the bottom of the aortic sinus (as shown in fig. 6 a); then the outer sheath 7 is retracted, the balloon 21 is pressurized to expand the balloon expansion part 212, and then the aortic valve system is wholly retracted to tightly attach the positioning surface 213 of the balloon expansion part 212 to the bottom 51 of the aortic valve 5 of the human body, so that the aortic valve system is precisely positioned and coaxial with the aorta due to the action of the columnar connecting part 211 of the balloon 21 (as shown in fig. 6 b); then the outer sheath 7 is withdrawn while expanding the columnar connection portion 211 of the balloon 21 to passively expand and release the balloon expandable stent 3 and position the balloon expandable stent on the aortic valve 5 (as shown in fig. 6 c); then the balloon 21 is decompressed, the aortic valve system is integrally conveyed forwards, the decompressed balloon 21 reaches the left ventricle, and the self-expandable stent 4 is conveyed into the released balloon-expandable stent 3 (as shown in fig. 6 d); after the self-expanding stent 4 is precisely positioned, the outer sheath 7 is retracted, the self-expanding stent 4 is released, the anchoring part of the self-expanding stent 4 is matched with the balloon expandable stent 3, and then the pushing and releasing device and the pressure-relieved special-shaped balloon catheter 2 are retracted (shown in fig. 6 e).
In summary, firstly, the special-shaped balloon 21 with a specific design is added at the front end of the push release device, when the valve is used, the balloon expansion part 212 of the special-shaped balloon 21 is released and expanded after being positioned approximately, so that the valve is anchored in the left ventricular outflow tract, the whole delivery system is retracted to anchor the balloon 21 under the aortic valve 5, and at the moment, the stent is firmly positioned, has good coaxiality, and can help to reduce or prevent paravalvular leakage due to firm positioning and good coaxiality. Secondly, the stent with the artificial valve 1 is designed in a double-layer manner, so that the full expansion and full fixation of the aortic valve 5 are ensured, the molding and the area in the stent are ensured, the compliance and the supporting force of the stent are ensured, the occurrence of paravalvular leakage and central reflux is reduced, the diameter of a sheath tube is not enlarged, and the risk of vascular complications is avoided. Furthermore, the aortic valve stent delivery system is simple to set, and the special-shaped balloon catheter 2 is added on the basis of the original delivery system. Finally, the invention is suitable for patients with aortic valve 5 stenosis and patients with aortic valve 5 insufficiency, and has stronger applicability.
The present invention has been described in detail with the purpose of enabling those skilled in the art to understand and practice the present invention, but not to limit the scope of the present invention, and the present invention is not limited to the above-described embodiments, and all equivalent changes or modifications according to the spirit of the present invention should be covered in the scope of the present invention.
Claims (6)
1. An aortic valve system comprising an aortic valve stent comprising a stent body, a prosthetic valve (1) attached to the stent body, and an aortic valve stent delivery system, characterized in that:
The stent body is of a double-layer stent structure and comprises a balloon expandable stent (3) and a self-expanding stent (4), the artificial valve (1) is connected to the self-expanding stent (4), and after the aortic valve stent is conveyed, the self-expanding stent (4) is positioned at the inner periphery of the balloon expandable stent (3) and tightly abuts against the balloon expandable stent (3) towards the outer periphery; the balloon expandable stent (3) is tightly supported on the aortic valve (52) of the human body towards the periphery, an anchoring structure for improving the binding force between the self-expandable stent (4) and the balloon expandable stent (3) is formed between the front end part of the self-expandable stent (4) and the balloon expandable stent (3),
The aortic valve stent delivery system comprises a push release device for delivering the aortic valve stent and a special-shaped balloon catheter (2) arranged at the front end of the push release device,
The push release device comprises an inner sheath (6) and an outer sheath (7),
The special-shaped balloon catheter (2) comprises a balloon (21), the balloon (21) is provided with a columnar connecting part (211) positioned at the proximal side of the balloon (21) and a balloon expanding part (212) communicated with the columnar connecting part (211) and positioned at the distal side of the columnar connecting part (211), the columnar connecting part (211) is connected with the front end of the inner sheath (6), the columnar connecting part (211) is made of a semi-compliant material, the balloon expanding part (212) is made of a compliant material,
When the aortic valve system is loaded, the self-expanding stent (4) is positioned in a lumen between the inner sheath (6) and the outer sheath (7), the special-shaped balloon catheter (2) is loaded at the front end of the inner sheath (6), the balloon expanding stent (3) is sleeved on the columnar connecting part (211), the special-shaped balloon catheter (2) and the balloon expanding stent (3) are both positioned in the outer sheath (7), after the balloon (21) is expanded, the balloon expanding part (212) forms a positioning surface (213) at one side close to the columnar connecting part (211), the positioning surface (213) is a plane and is perpendicular to the axis of the columnar connecting part (211), when the aortic valve stent delivery system is used, the balloon expanding part (212) of the balloon (21) is positioned in a left outflow channel and is attached to the bottom part (51) of the human body valve (5) through the positioning surface (213), and the positioning surface is tightly surrounding the peripheral valve (213) and is a peripheral part of the columnar connecting part (211).
2. The aortic valve system according to claim 1, wherein:
The anchoring structure comprises an anchoring part positioned at the front end of the self-expanding stent (4), and the anchoring part is matched with the shape of the balloon expanding stent (3).
3. The aortic valve system according to claim 1, wherein:
The anchoring structure comprises a first matching part formed on the outer peripheral surface of the front end of the self-expanding bracket (4) and a second matching part formed on the inner peripheral surface of the balloon expanding bracket (3), and the first matching part and the second matching part are matched and fixed.
4. The aortic valve system according to claim 1, wherein:
the anchoring structure comprises an anchoring part positioned at the front end of the self-expanding stent (4), a first matching part formed on the outer circumferential surface of the anchoring part, and a second matching part formed on the inner circumferential surface of the balloon expanding stent (3), wherein the anchoring part is matched with the shape of the balloon expanding stent (3), and the first matching part is matched and fixed with the second matching part.
5. The aortic valve system according to claim 3 or 4, wherein:
The first matching part and the second matching part are matched in a floating point matching mode, a tooth matching mode or a thread matching mode.
6. The aortic valve system according to claim 1, wherein:
The length of the balloon expandable stent (3) is 1/6-1/3 of that of the self-expanding stent (4), and the balloon expandable stent (3) is positioned at the periphery of the front end of the self-expanding stent (4) after the stent is conveyed.
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| AU2022389638A1 (en) * | 2021-11-17 | 2024-06-06 | Beijing Balance Medical Technology Co., Ltd. | Split type precisely-anchorable interventional aortic valve system |
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| CN101180010A (en) * | 2005-05-24 | 2008-05-14 | 爱德华兹生命科学公司 | Rapid deployment prosthetic heart valve |
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