CN115381601A - A tricuspid valve prosthesis fixed on the interventricular septum with a sealing device - Google Patents
A tricuspid valve prosthesis fixed on the interventricular septum with a sealing deviceDownload PDFInfo
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- CN115381601A CN115381601ACN202211080784.4ACN202211080784ACN115381601ACN 115381601 ACN115381601 ACN 115381601ACN 202211080784 ACN202211080784 ACN 202211080784ACN 115381601 ACN115381601 ACN 115381601A
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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
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
- 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
Translated fromChinese
Description
Translated fromChinese技术领域technical field
本申请属于医疗器械领域，具体涉及一种固定在室间隔上带有密封装置的三尖瓣假体。The application belongs to the field of medical devices, in particular to a tricuspid valve prosthesis fixed on the interventricular septum with a sealing device.
背景技术Background technique
三尖瓣返流一般由肺动脉高压，右室扩大，三尖瓣环扩张引起，临床上常以三尖瓣返流的病因(左心衰，肺动脉高压等)的表现为常见，出现三尖瓣返流后，乏力，腹水，水肿，肝区疼痛，消化不良，纳差等右心衰症状加重。三尖瓣轻度返流并无明显的临床症状，但当严重返流时即需要手术治疗。Tricuspid regurgitation is generally caused by pulmonary hypertension, enlarged right ventricle, and dilation of the tricuspid valve ring. Clinically, the etiology of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.) After reflux, symptoms of right heart failure such as fatigue, ascites, edema, pain in the liver area, indigestion, and anorexia aggravate. Mild tricuspid regurgitation has no obvious clinical symptoms, but when severe regurgitation requires surgical treatment.
针对二尖瓣和三尖瓣疾病的传统治疗手段包括适用于轻度至重度反流的药物治疗，和有相对应手术指征的外科手术方法。其中，外科手术方法还包括瓣膜置换术和瓣膜修补术。在外科手术方法中，典型的开胸、开心手术侵入性过大，需要建立体外循环，具有较高的并发症发生率和感染风险。患者很多耐受不了巨大的外科风险而只能无奈等待死亡。Traditional treatments for mitral and tricuspid valve disease include medical therapy for mild to severe regurgitation and surgical approaches where appropriate. Among them, surgical methods also include valve replacement and valve repair. Among the surgical methods, typical thoracotomy and open-heart surgery are too invasive and require the establishment of extracorporeal circulation, which has a high complication rate and infection risk. Many patients cannot tolerate the huge surgical risk and can only wait for death helplessly.
专利CN201922307893.5公开了一种介入式人工心脏瓣膜及医用装置，包括瓣膜支架和锚固部，瓣膜支架具有本体段和流入端的裙边段；本体段包括多个周向设置支撑部；至少部分支撑部径向向外且朝向流入端方向延伸；锚固部包括至少两个锚固件；锚固件具有圆弧形区段、辅助区段以及连接部；圆弧形区段的自由端具有连接部，连接部能够与连接元件可拆卸地连接；辅助区段连接于圆弧形区段，辅助区段设置于相对圆弧形区段靠近流出端一侧且靠近本体部的一侧，用于约束人体心脏瓣膜。该技术方案中裙边段的外周边缘设有下翻结构，其用于配合锚固部锚定自体瓣环，虽然能起到一定的防止反流的效果，但由于裙边段由几根主要的支撑杆件组成，导致裙边段不能完全贴合自体瓣环，或者裙边段贴合自体瓣环后，由于相邻支撑杆件之间的间隙较大，导致心脏在跳动的过程中，其间隙部分会脱离自体瓣环，使其发生严重的血液反流；并且，自体瓣叶的两端区域与瓣叶的中心区域，其反流的程度也有所不同，例如：在瓣叶的中心区域，其反流程度要比瓣叶的两端区域大，而该方案中裙边段相邻的支撑杆件之间间隙较大，其支撑杆件没有落在瓣叶中心区域对应的瓣环上或者只有一个或两个支撑杆件落在瓣叶中心区域对应的瓣环上，这会导致裙边段与瓣叶中心区域对应的瓣环部分贴合不够紧密，在心脏不断泵血的过程中，其密封装置与心脏组织之间容易有间隙产生，导致发生反流的情况。Patent CN201922307893.5 discloses an interventional artificial heart valve and a medical device, including a valve support and an anchoring part. The valve support has a body section and a skirt section at the inflow end; the body section includes a plurality of circumferentially arranged support parts; at least partially supports The portion extends radially outward and toward the inflow end; the anchoring portion includes at least two anchoring pieces; the anchoring piece has an arc-shaped section, an auxiliary section and a connecting portion; the free end of the arc-shaped section has a connecting portion, connected The part can be detachably connected with the connecting element; the auxiliary section is connected to the arc-shaped section, and the auxiliary section is arranged on the side of the relative arc-shaped section near the outflow end and the side of the main body, for constraining the human heart valve. In this technical solution, the outer peripheral edge of the skirt section is provided with a downturned structure, which is used to cooperate with the anchoring part to anchor the native valve annulus. Although it can play a certain role in preventing reflux, the skirt section is composed of several main As a result, the skirt section cannot fully fit the native valve annulus, or after the skirt section fits the native valve annulus, due to the large gap between the adjacent support rods, the heart is beating. The gap part will break away from the native valve annulus, causing severe blood regurgitation; and, the degree of regurgitation is also different between the two end regions of the native valve leaflet and the central region of the valve leaflet, for example: in the central region of the valve leaflet , the degree of regurgitation is larger than that of the two ends of the valve leaflet, and in this scheme, the gap between the adjacent support rods of the skirt section is relatively large, and the support rod does not fall on the annulus corresponding to the central area of the leaflet or only One or two supporting rods fall on the valve annulus corresponding to the central area of the leaflet, which will cause the skirt segment to not fit tightly with the annulus corresponding to the central area of the valve leaflet. During the continuous pumping process of the heart, its There is a tendency for a gap to develop between the sealing device and the heart tissue, resulting in a reflux situation.
因此，本领域的技术人员致力于开发一种固定在室间隔上带有密封装置的三尖瓣假体，使得瓣膜假体在植入后能实时紧贴自体瓣环，避免心脏跳动过程中，由于心房壁挤压密封装置，导致其不能紧密贴合自体瓣环，出现血液反流等问题。Therefore, those skilled in the art are committed to developing a tricuspid valve prosthesis fixed on the interventricular septum with a sealing device, so that the valve prosthesis can cling to the native valve annulus in real time after implantation, avoiding the Due to the compression of the sealing device by the atrium wall, it cannot closely fit the native valve annulus, and problems such as blood regurgitation occur.
发明内容Contents of the invention
本发明所要解决的技术问题是提供一种固定在室间隔上带有密封装置的三尖瓣假体，使得瓣膜假体在植入后能实时紧贴自体瓣环，避免心房壁挤压密封装置时，导致其不能紧密贴合自体瓣环，出现血液反流等问题。The technical problem to be solved by the present invention is to provide a tricuspid valve prosthesis fixed on the interventricular septum with a sealing device, so that the valve prosthesis can closely adhere to the native valve annulus in real time after implantation, avoiding the atrial wall from squeezing the sealing device When it is used, it will not be able to fit closely to the native valve annulus, and problems such as blood regurgitation will occur.
为了解决上述技术问题，本申请通过下述技术方案得以解决：In order to solve the above technical problems, the application is solved through the following technical solutions:
根据本发明的一方面，一种固定在室间隔上带有密封装置的三尖瓣假体，包括支架、人工瓣叶、密封装置以及锚定件，所述人工瓣叶设置在支架内，并且所述支架的近端通过所述锚定件固定在患者的室间隔组织上，所述密封装置包括心房段，所述心房段的一端连接在位于支架远端的固定点，并向下延伸形成凸向支架外侧的心室段，在所述支架安装就位后，至少部分所述心房段贴于心房壁，自体瓣环位于所述心房段与心室段之间，当心房壁挤压所述的密封装置时，所述心房段的另一端以所述固定点为支点向所述支架的中心摆动，并且，所述心房段以所述固定点为支点进一步带动所述心室段向心房方向旋转。According to one aspect of the present invention, a tricuspid valve prosthesis with a sealing device fixed on the interventricular septum includes a bracket, an artificial valve leaflet, a sealing device and an anchor, the artificial valve leaflet is arranged in the bracket, and The proximal end of the stent is fixed on the patient's interventricular septal tissue through the anchor, the sealing device includes an atrium segment, one end of the atrium segment is connected to a fixed point at the far end of the stent, and extends downward to form a The ventricular segment protruding to the outside of the stent, after the stent is installed in place, at least part of the atrium segment is attached to the atrium wall, and the native valve ring is located between the atrium segment and the ventricular segment, when the atrium wall squeezes the When sealing the device, the other end of the atrium segment swings toward the center of the bracket with the fixed point as a fulcrum, and the atrium segment further drives the ventricular segment to rotate toward the atrium with the fixed point as a fulcrum.
本发明的目的还可以通过以下技术方案来进一步实现：The object of the present invention can also be further realized by the following technical solutions:
作为本发明的进一步改进，当所述的三尖瓣假体植入后，所述心房段紧贴自体瓣环和心房壁，并且，心房壁挤压所述心房段的游离缘部分，心房段的游离缘向支架的中心方向翻折，进一步地，所述心房段带动所述心室段向所述支架的远端方向翻折并贴紧自体瓣环的下方，可以有效防止心室内血液流向心房，从而有效防止瓣周漏。As a further improvement of the present invention, when the tricuspid valve prosthesis is implanted, the atrial segment is close to the native valve annulus and the atrium wall, and the atrial wall squeezes the free edge of the atrial segment, and the atrial segment The free edge of the stent is folded toward the center of the stent, and further, the atrial segment drives the ventricular segment to be folded toward the distal end of the stent and sticks to the bottom of the native valve annulus, which can effectively prevent the blood in the ventricle from flowing to the atrium , so as to effectively prevent paravalvular leakage.
作为本发明的进一步改进，所述心房段能顺应心房内壁的解剖形态，并且，所述的心房段还具备一定刚性，使得心房壁挤压所述的密封装置时，心房壁带动所述心房段的另一端向所述支架的中心靠拢，并且，所述心房段以所述固定点为支点带动所述心室段向所述支架的远端方向翻折。As a further improvement of the present invention, the atrial segment can conform to the anatomical shape of the inner wall of the atrium, and the atrium segment also has a certain rigidity, so that when the atrial wall squeezes the sealing device, the atrial wall drives the atrial segment The other end of the atrium moves closer to the center of the stent, and the atrial segment uses the fixed point as a fulcrum to drive the ventricular segment to fold toward the distal end of the stent.
作为本发明的进一步改进，所述心房段与所述心室段之间设有柔性的织物层，当所述的三尖瓣假体植入后，自体瓣环贴合所述织物层，并且，当心房收缩时，心房壁挤压所述的密封装置，所述心房段的另一端带动所述织物层向上提拉所述心室段，使得所述心室段向所述支架的远端方向翻折并贴紧自体瓣环。As a further improvement of the present invention, a flexible fabric layer is provided between the atrial segment and the ventricular segment, and after the tricuspid valve prosthesis is implanted, the native valve ring fits the fabric layer, and, When the atrium contracts, the atrial wall squeezes the sealing device, and the other end of the atrium segment drives the fabric layer to lift the ventricular segment upward, so that the ventricular segment is folded toward the distal end of the stent And close to the native annulus.
作为本发明的进一步改进，所述柔性的织物层可以采用延伸性较优的涤纶布，使得自体瓣环贴合织物层后可以有一定的弹性空间，保证自体瓣环能实时贴紧织物层，防止心脏运动过程出现瓣周漏。As a further improvement of the present invention, the flexible fabric layer can use polyester cloth with better extensibility, so that there can be a certain elastic space after the autologous valve annulus is attached to the fabric layer, ensuring that the autologous valve annulus can be tightly attached to the fabric layer in real time, Prevents paravalvular leaks during cardiac exercise.
作为本发明的进一步改进，在所述支架中轴线所在的截面上，所述密封装置呈弧形结构设置；弧形结构设置便于夹合自体瓣环，并且，弧形结构可以使得心房段受力翻折后带动心室段向上翻折，使得心室段能贴紧自体瓣环的下方。As a further improvement of the present invention, on the section where the central axis of the stent is located, the sealing device is arranged in an arc-shaped structure; the arc-shaped structure is convenient for clamping the native valve annulus, and the arc-shaped structure can make the atrial segment stressed After being folded, the ventricular segment is driven to be folded upward, so that the ventricular segment can be attached to the bottom of the native valve annulus.
作为本发明的进一步改进，所述密封装置的心房段被配置为适于贴靠自体瓣环和心房壁组织，并且，在垂直于所述支架中轴线的横截面上，所述心房段的横截面积大于自体瓣环的横截面积。As a further improvement of the present invention, the atrial segment of the sealing device is configured to fit against the native valve annulus and the atrial wall tissue, and, on a cross section perpendicular to the central axis of the stent, the atrial segment The cross-sectional area is larger than the cross-sectional area of the native valve annulus.
作为本发明的进一步改进，所述心室段设有第一凸起、第二凸起和第三凸起，当所述的三尖瓣假体植入后，所述的第一凸起、第二凸起和第三凸起分别位于自体瓣叶交界处，由于瓣叶交界处没有自体瓣叶阻挡更容易发生反流，因此心室段针对性的在相邻瓣叶的交界处设置第一凸起、第二凸起和第三凸起，使其能进一步填补到瓣叶的交界处，从而防止血液反流。As a further improvement of the present invention, the ventricular segment is provided with a first protrusion, a second protrusion and a third protrusion, and when the tricuspid valve prosthesis is implanted, the first protrusion, the second protrusion The second protrusion and the third protrusion are respectively located at the junction of the native valve leaflets. Since the junction of the valve leaflets is not blocked by the native valve leaflets, regurgitation is more likely to occur, so the ventricular segment is targeted to set the first protrusion at the junction of the adjacent leaflets. The protrusion, the second protrusion and the third protrusion allow it to further fill in the junction of the valve leaflets, thereby preventing blood backflow.
作为本发明的进一步改进，所述第一凸起设置在前瓣叶和后瓣叶的交界处，所述第二凸起设置在前瓣叶和隔瓣叶的交界处，所述第三凸起设置在后瓣叶和隔瓣叶的交接处。As a further improvement of the present invention, the first protrusion is arranged at the junction of the front leaflet and the rear leaflet, the second protrusion is arranged at the junction of the front leaflet and the septal leaflet, and the third protrusion It is located at the junction of the posterior leaflet and the septal leaflet.
作为本发明的进一步改进，所述支架的远端设有第一杆件、第二杆件和第三杆件，并且，所述第一杆件、第二杆件和第三杆件分别位于自体瓣叶交界处对应的自体瓣环上；第一杆件、第二杆件和第三杆件分别与第一凸起、第二凸起和第三凸起的位置轴向对应，能进一步对瓣叶交界处的位置进行补位，避免瓣叶交界处发生反流。As a further improvement of the present invention, the distal end of the bracket is provided with a first rod, a second rod and a third rod, and the first rod, the second rod and the third rod are respectively located at On the corresponding native valve annulus at the junction of the native valve leaflets; the first rod, the second rod and the third rod are respectively axially corresponding to the positions of the first protrusion, the second protrusion and the third protrusion, which can further The position of the leaflet junction is supplemented to avoid regurgitation at the leaflet junction.
作为本发明的进一步改进，所述第一杆件、第二杆件和第三杆件的游离端延伸至所述心房段的外侧，并且，所述第一杆件、第二杆件和第三杆件的游离端向所述支架的远端方向弯曲以适于贴靠心房壁；由于瓣叶交界处的反流相对严重，因此第一杆件、第二杆件和第三杆件的游离端延伸至心房段的外侧，可与第一凸起、第二凸起和第三凸起配合进一步对瓣叶交界处进行补位，使得密封装置能填充到瓣叶交界处，避免反流的发生。As a further improvement of the present invention, the free ends of the first rod, the second rod and the third rod extend to the outside of the atrium segment, and the first rod, the second rod and the third rod The free ends of the three rods are bent toward the distal end of the stent so as to be suitable for abutting against the atrium wall; since the regurgitation at the junction of the leaflets is relatively serious, the first rod, the second rod and the third rod The free end extends to the outside of the atrium segment, and can cooperate with the first protrusion, the second protrusion and the third protrusion to further supplement the junction of the leaflets, so that the sealing device can be filled to the junction of the leaflets to avoid regurgitation happened.
作为本发明的进一步改进，所述第一杆件、第二杆件和第三杆件的游离端部分设有缓冲结构，其缓冲结构不仅能避免戳伤心房壁，还能更好的顺应心房壁，达到良好的贴靠效果，避免出现缝隙，发生血液反流。As a further improvement of the present invention, the free ends of the first rod, the second rod and the third rod are provided with buffer structures, which can not only avoid piercing the atrial wall, but also better conform to the atrium The wall can achieve a good abutment effect, avoiding gaps and blood reflux.
作为本发明的进一步改进，所述第一杆件、第二杆件和第三杆件之间设有柔性裙边；在三尖瓣假体安装就位后，第一杆件、第二杆件和第三杆件贴靠心房壁，并且相邻的杆件之间有柔性的裙边，柔性裙边可以顺应并贴合心房壁。As a further improvement of the present invention, a flexible skirt is provided between the first rod, the second rod and the third rod; after the tricuspid valve prosthesis is installed in place, the first rod, the second rod The first member and the third rod are close to the wall of the atrium, and there is a flexible skirt between the adjacent rods, and the flexible skirt can conform to and fit the wall of the atrium.
作为本发明的进一步改进，在自然状态下，所述心室段的游离端向支架的远端方向弯曲；心室段的游离端与心房段配合能紧紧抵住自体瓣环组织，有效增加密封装置对自体瓣环的夹持力，实现更好的防漏效果。As a further improvement of the present invention, in the natural state, the free end of the ventricular segment bends toward the distal end of the stent; the free end of the ventricular segment cooperates with the atrium segment to tightly against the native valve annulus tissue, effectively increasing the sealing device The clamping force on the native valve ring achieves better leak-proof effect.
根据本发明的另一方面，一种固定在室间隔上带有密封装置的三尖瓣假体，包括支架、人工瓣叶、密封装置以及锚定件，所述人工瓣叶设置在支架内，并且所述支架的近端通过所述锚定件固定在患者的室间隔组织上，所述密封装置包括心房段和心室段，所述支架的远端设有支撑杆，其中，所述心房段与所述支撑杆固定连接，在所述支架安装就位后，至少部分所述心房段贴于心房壁，自体瓣环位于所述心房段与心室段之间，当心房壁挤压所述的密封装置时，所述支撑杆的游离端向所述支架的中心靠拢，并带动所述心室段向所述支架的远端方向翻折。According to another aspect of the present invention, a tricuspid valve prosthesis with a sealing device fixed on the interventricular septum includes a bracket, an artificial valve leaflet, a sealing device and an anchor, the artificial valve leaflet is arranged in the bracket, And the proximal end of the stent is fixed on the patient's interventricular septal tissue through the anchor, the sealing device includes an atrium segment and a ventricular segment, and a support rod is provided at the far end of the stent, wherein the atrial segment It is fixedly connected with the support rod. After the bracket is installed in place, at least part of the atrial segment is attached to the atrial wall, and the native valve ring is located between the atrial segment and the ventricular segment. When the atrial wall squeezes the When sealing the device, the free ends of the support rods move closer to the center of the stent, and drive the ventricular segment to fold toward the distal end of the stent.
与现有技术相比，本申请的优点在于：Compared with the prior art, the advantages of the present application are:
1.现有技术中，在垂直于支架中轴线的横截面方向上，密封装置的横截面积要大于自体瓣环的横截面积，使得密封装置能完全覆盖整个自体瓣环，并且心房段的游离缘部分要贴靠心房壁，才能达到较优的防漏效果，但心房的内壁面不是非常规整、平滑的，因此心房壁某些部位对心房段的挤压力较大，导致心房段产生褶皱并出现间隙，导致血液发生反流，此外，在假体长期植入后，由于瓣膜反流减小，心房会重构并缩小至病变前的尺寸，这同样会导致心房壁对密封装置的挤压力过大，导致心房段产生褶皱并出现缝隙，从而导致血液反流；区别于现有技术，本发明的一实施例中，支架利用锚定件固定在患者的室间隔组织上，可有效限制支架轴向移动，使得支架能牢靠的固定在心内，并且，密封装置包括心房段和心室段，当心房段受到心房壁挤压时，心室段会以固定点为支点向支架的远端翻折并贴紧自体瓣环的下方，有效避免因心房挤压心房段褶皱而出现缝隙，防止出现瓣周漏。1. In the prior art, in the cross-sectional direction perpendicular to the central axis of the stent, the cross-sectional area of the sealing device is larger than that of the native valve annulus, so that the sealing device can completely cover the entire native valve annulus, and the atrial segment The part of the free edge must be close to the atrial wall to achieve a better leak-proof effect, but the inner wall of the atrium is not very regular and smooth, so some parts of the atrial wall have a greater extrusion force on the atrial segment, resulting in a In addition, after long-term implantation, the atrium will remodel and shrink to the size before the disease due to the reduction of valve regurgitation, which will also cause the atrial wall to seal the device. Excessive extrusion force will cause folds and gaps in the atrial segment, resulting in blood reflux; different from the prior art, in one embodiment of the present invention, the stent is fixed on the patient's interventricular septal tissue with anchors, which can Effectively restrict the axial movement of the stent, so that the stent can be firmly fixed in the heart, and the sealing device includes the atrial segment and the ventricular segment. Folding and sticking to the bottom of the native valve ring can effectively avoid gaps caused by the atrium squeezing the folds of the atrial segment and prevent paravalvular leakage.
2.区别于现有技术，本发明的一实施例中，申请人通过对众多心脏解剖发现，右心室游离壁与三尖瓣瓣环之间存在较大凹陷，且不同患者凹陷程度存在差异，导致锚定位置因人而异，使得锚定效果无法得到保障；申请人根据发现的心脏结构特性进而设计出本申请的技术方案，当本申请的技术方案应用在三尖瓣，可以很好地利用室间隔与三尖瓣的隔瓣平直这一特性，将心脏瓣膜假体通过室间隔固定，解决了因病人心室游离壁与隔瓣之间有凹陷程度不同而锚定困难的这一难题，降低三尖瓣植入时锚定的难度，提高瓣膜假体植入的可靠性。2. Different from the prior art, in one embodiment of the present invention, the applicant found through dissection of many hearts that there is a large depression between the free wall of the right ventricle and the tricuspid valve annulus, and the degree of depression varies from patient to patient. As a result, the anchoring position varies from person to person, so that the anchoring effect cannot be guaranteed; the applicant then designed the technical solution of the application based on the discovered structural characteristics of the heart. When the technical solution of the application is applied to the tricuspid valve, it can be well Using the straight feature of the interventricular septum and the tricuspid valve, the heart valve prosthesis is fixed through the interventricular septum, which solves the difficult problem of anchoring due to the different degrees of depression between the ventricular free wall and the septal valve. , reduce the difficulty of anchoring during tricuspid valve implantation, and improve the reliability of valve prosthesis implantation.
3.区别于现有技术，本发明的一实施例中，房室瓣压差较大；申请人创造性的利用室间隔的肌肉纤维组织的厚度大于心室游离壁这一特性，将心脏瓣膜假体通过室间隔固定，避免心脏瓣膜假体锚定在脆弱的左心室游离壁导致心脏破裂等严重症状的发生。3. Different from the prior art, in one embodiment of the present invention, the atrioventricular valve pressure difference is relatively large; the applicant creatively uses the characteristic that the thickness of the muscle fiber tissue of the interventricular septum is greater than that of the ventricular free wall, and the heart valve prosthesis Through the fixation of the interventricular septum, the anchoring of the heart valve prosthesis on the fragile left ventricular free wall can avoid serious symptoms such as heart rupture.
4.区别于现有技术，本发明的一实施例中，心房段与所述心室段之间设有柔性的织物层，并且织物层具有较好的延展性，使得自体瓣环贴合织物层后可以有一定的弹性空间，保证自体瓣环能实时贴紧织物层，防止心脏运动过程出现瓣周漏。4. Different from the prior art, in one embodiment of the present invention, a flexible fabric layer is provided between the atrium segment and the ventricular segment, and the fabric layer has good ductility, so that the autogenous valve annulus fits the fabric layer Afterwards, there can be a certain amount of elastic space to ensure that the autogenous valve annulus can adhere to the fabric layer in real time to prevent paravalvular leakage during heart movement.
5.区别于现有技术，本发明的一实施例中，由于自体瓣叶交界处没有瓣叶隔挡，因此更容易发生反流，心室段设有第一凸起、第二凸起和第三凸起，当假体被植入后，第一凸起、第二凸起和第三凸起分别位于自体瓣叶的交界处，使其能进一步填补到瓣叶的交界处，从而防止血液反流。5. Different from the prior art, in one embodiment of the present invention, since there is no leaflet barrier at the junction of the native valve leaflets, regurgitation is more likely to occur, and the ventricular segment is provided with a first protrusion, a second protrusion and a second protrusion. Three protrusions, when the prosthesis is implanted, the first protrusion, the second protrusion and the third protrusion are respectively located at the junction of the native valve leaflets, so that it can further fill the junction of the valve leaflets, thereby preventing blood reflux.
6.区别于现有技术，本发明的一实施例中，支架的远端设有第一杆件、第二杆件和第三杆件，不仅能增加支架在心房内的锚定力，同时还能配合心室段的凸起进一步对瓣叶交界处的位置进行补位，避免瓣叶交界处发生反流。6. Different from the prior art, in an embodiment of the present invention, the distal end of the stent is provided with a first rod, a second rod and a third rod, which can not only increase the anchoring force of the stent in the atrium, but also It can also cooperate with the bulge of the ventricular segment to further supplement the position of the junction of the leaflets to avoid regurgitation at the junction of the leaflets.
7．区别于现有技术，本发明的一实施例中，支架的远端设有支撑杆，其密封装置的心房段与支撑杆固定连接，在假体植入后，自体瓣环被卡在心房段与心室段之间，并且，当心房壁挤压密封装置时，支撑杆的游离端向支架的中心靠拢，并带动心室段向支架的远端方向翻折并贴紧自体瓣环的下方，有效避免因心房挤压心房段褶皱而出现缝隙，防止出现瓣周漏。7. Different from the prior art, in one embodiment of the present invention, the distal end of the stent is provided with a support rod, and the atrial segment of the sealing device is fixedly connected with the support rod. After the prosthesis is implanted, the native valve ring is stuck in the atrium segment between the ventricle and the ventricular segment, and when the atrial wall squeezes the sealing device, the free end of the support rod moves closer to the center of the stent, and drives the ventricular segment to fold toward the distal end of the stent and stick to the bottom of the native valve annulus, effectively Avoid gaps due to atrial compression of atrial segment folds and prevent paravalvular leaks.
本申请的实施例能够实现其它未一一列出的有利技术效果，这些其它的技术效果在下文中可能有部分描述，并且对于本领域的技术人员而言在阅读了本申请后是可以预期和理解的。Embodiments of the present application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below, and are expected and understood by those skilled in the art after reading the present application of.
附图说明Description of drawings
通过参考下文的描述连同附图，这些实施例的上述特征和优点及其他特征和优点以及实现它们的方式将更显而易见，并且可以更好地理解本申请的实施例，在附图中：The above-mentioned and other features and advantages of these embodiments, and the manner in which they are achieved, will become more apparent and a better understanding of embodiments of the present application can be obtained by referring to the following description together with the accompanying drawings in which:
图1a～1c为本发明三尖瓣假体的整体结构示意图与三尖瓣假体设置在瓣环处的位置示意图。1a-1c are schematic diagrams of the overall structure of the tricuspid valve prosthesis of the present invention and a schematic diagram of the position of the tricuspid valve prosthesis at the valve annulus.
图2a～2d为本发明心房段、心室段、与支架的具体结构示意图。2a-2d are schematic structural views of the atrial segment, the ventricular segment, and the stent of the present invention.
图3a～3c为本发明心房壁发生挤压，心室段向所述支架的远端方向翻折并贴紧自体瓣环的示意图，其中，图3c中的箭头是血液的意思，心室段远端阻挡了血液朝心房流动。Figures 3a to 3c are schematic diagrams showing that the atrial wall of the present invention is squeezed, and the ventricular segment is folded toward the distal end of the stent and attached to the native valve annulus, wherein the arrow in Figure 3c means blood, and the ventricular segment is distally Blocking the flow of blood to the atrium.
图4a和4b为本发明的另一实施方式。Figures 4a and 4b illustrate another embodiment of the present invention.
具体实施方式Detailed ways
下面结合附图与实施例对本申请作进一步详细描述。The application will be further described in detail below in conjunction with the accompanying drawings and embodiments.
本申请所述的近端是指接近手术操作者的一端，所述的远端是指远离手术操作者的一端。The proximal end mentioned in this application refers to the end close to the operator, and the distal end refers to the end away from the operator.
具体实施例：Specific examples:
在以下对附图和具体实施方式的描述中，将阐述本申请的一个或多个实施例的细节。从这些描述、附图以及权利要求中，可以清楚本申请的其它特征、目的和优点。The details of one or more embodiments of the application are set forth in the following description of the accompanying drawings and the detailed description. Other features, objects and advantages of the present application will be apparent from the description, drawings and claims.
应当理解，所图示和描述的实施例在应用中不限于在以下描述中阐明或在附图中图示的构件的构造和布置的细节。所图示的实施例可以是其它的实施例，并且能够以各种方式来实施或执行。各示例通过对所公开的实施例进行解释而非限制的方式来提供。实际上，将对本领域技术人员显而易见的是，在不背离本申请公开的范围或实质的情况下，可以对本申请的各实施例作出各种修改和变型。例如，作为一个实施例的一部分而图示或描述的特征，可以与另一实施例一起使用，以仍然产生另外的实施例。因此，本申请公开涵盖属于所附权利要求及其等同要素范围内的这样的修改和变型。It should be understood that the illustrated and described embodiments are not limited in application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments are capable of other embodiments and of being practiced or carried out in various ways. Each example is provided by way of explanation, not limitation, of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the various embodiments of the present application without departing from the scope or spirit of the present disclosure. For example, features illustrated or described as part of one embodiment, can be used with another embodiment to still yield a further embodiment. Accordingly, it is intended that the present disclosure covers such modifications and alterations as come within the scope of the appended claims and their equivalents.
同样，可以理解，本文中所使用的词组和用语是出于描述的目的，而不应当被认为是限制性的。本文中的“包括”、“包含”或“具有”及其变型的使用，旨在开放式地包括其后列出的项及其等同项以及附加的项。Also, it is to be understood that the phrases and terms used herein are for the purpose of description and should not be regarded as limiting. The use of "comprising", "comprising" or "having" and variations thereof herein is intended to openly include the items listed thereafter and equivalents thereof as well as additional items.
下面将参考本申请的若干方面的不同的实施例和示例对本申请进行更详细的描述。The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.
本申请中，“近端”是指接近心尖的一端，“远端”是指远离心尖的一端。In this application, "proximal end" refers to the end close to the apex of the heart, and "distal end" refers to the end away from the apex of the heart.
第一实施例first embodiment
人体心脏的三尖瓣具有前瓣叶、后瓣叶和膈瓣叶。前瓣叶、后瓣叶和膈瓣叶在心脏收缩时处于关闭状态，当前瓣叶、后瓣叶和膈瓣叶中的一者在关闭状态下不能正常关闭时，即产生瓣膜返流。The tricuspid valve of the human heart has an anterior leaflet, a posterior leaflet, and a diaphragmatic leaflet. The anterior valve leaflet, the posterior valve leaflet and the diaphragm valve leaflet are in the closed state when the heart contracts, and when one of the anterior valve leaflet, the posterior valve leaflet and the diaphragm valve leaflet cannot close normally in the closed state, valvular regurgitation occurs.
在本实施例一中，一种具有密封装置3的三尖瓣假体，如图1a～1c所示，包括支架1、人工瓣叶2、密封装置3以及锚定件4，所述人工瓣叶2设置在支架1内，如图2d所示，并且所述支架1的近端通过所述锚定件4固定在患者的室间隔组织上，所述密封装置3包括心房段31，所述心房段31的一端连接在位于支架1远端的固定点32，并向下延伸形成凸向支架1外侧的心室段33，在所述支架1安装就位后，至少部分所述心房段31贴于心房壁，自体瓣环位于所述心房段31与心室段33之间，当心房壁挤压所述的密封装置3时，心房壁带动所述心房段31的另一端向所述支架1的中心靠拢，并且，所述心房段31以所述固定点32为支点带动所述心室段33向所述支架1的远端方向翻折并贴紧自体瓣环的下方，有效避免因心房挤压心房段31褶皱而出现缝隙，防止出现瓣周漏。In the first embodiment, a tricuspid valve prosthesis with a
本实施例中的锚定件4（又可称为“锚定针”、“锚针”，等等）的实施例的更多细节例如在同一申请人的专利申请No.202120566797.7中详细地描述过，该专利申请的内容通过援引加入结合于本申请中；支架1的近端通过锚定针固定在患者的室间隔上，该种锚定方式能避免支架1发生相对的轴向移动，并且，支架1植入后，密封装置3会相对发生径向的位移，而径向晃动的过程中，心房壁会对心房段31造成挤压，此时，心室段33会向上翘起并贴紧自体瓣环的下方，避免血液反流，如图3a～3c所示。More details of the embodiment of the anchor 4 (also called "anchor needle", "anchor needle", etc.) in this embodiment are described in detail in the patent application No. 202120566797.7 of the same applicant However, the content of this patent application is incorporated in this application by reference; the proximal end of the
但是支架1植入后，会随心脏的跳动发生径向的位移，导致密封装置3不能贴紧自体瓣环或心房组织，从而发生反流。However, after the
在本实施例一中，当所述的三尖瓣假体植入后，所述心房段31紧贴自体瓣环和心房壁，并且，心房壁挤压所述心房段31的游离缘部分，心房段31的游离缘向支架1的中心方向翻折，进一步地，所述心房段31带动所述心室段33向所述支架1的远端方向翻折并贴紧自体瓣环的下方，可以有效防止心室内血液流向心房，从而有效防止瓣周漏。In the first embodiment, after the tricuspid valve prosthesis is implanted, the
在本实施例一中，所述心房段31与所述心室段33之间设有柔性的织物层5，当所述的三尖瓣假体植入后，自体瓣环贴合所述织物层5，并且，当心房收缩时，心房壁挤压所述的密封装置3，所述心房段31的另一端带动所述织物层5向上提拉所述心室段33，使得所述心室段33向所述支架1的远端方向翻折并贴紧自体瓣环；所述柔性的织物层5可以采用延伸性较优的涤纶布，使得自体瓣环贴合织物层5后可以有一定的弹性空间，保证自体瓣环能实时贴紧织物层5，防止心脏运动过程出现瓣周漏，如图3c所示。In the first embodiment, a
在本实施例一中，在所述支架1中轴线所在的截面上，所述密封装置3呈弧形结构设置；弧形结构设置便于夹合自体瓣环，并且，弧形结构可以使得心房段31受力翻折后带动心室段33向上翻折，使得心室段33能贴紧自体瓣环的下方。In the first embodiment, on the section where the central axis of the
在本实施例一中，所述密封装置3的心房段31被配置为适于贴靠自体瓣环和心房壁组织，并且，在垂直于所述支架1中轴线的横截面上，所述心房段31的横截面积大于自体瓣环的横截面积。In the first embodiment, the
在本实施例一中，所述心室段33设有第一凸起331、第二凸起332和第三凸起333，如图2b所示，当所述的三尖瓣假体植入后，所述的第一凸起331、第二凸起332和第三凸起333分别位于自体瓣叶交界处，由于瓣叶交界处没有自体瓣叶阻挡更容易发生反流，因此心室段33针对性的在相邻瓣叶的交界处设置第一凸起331、第二凸起332和第三凸起333，使其能进一步填补到瓣叶的交界处，从而防止血液反流。In the first embodiment, the
在本实施例一中，所述第一凸起331设置在前瓣叶和后瓣叶的交界处，所述第二凸起332设置在前瓣叶和隔瓣叶的交界处，所述第三凸起333设置在后瓣叶和隔瓣叶的交接处。In the first embodiment, the
在本实施例一中，所述支架1的远端设有第一杆件311、第二杆件312和第三杆件313，如图2a所示，并且，所述第一杆件311、第二杆件312和第三杆件313分别位于自体瓣叶交界处对应的自体瓣环上；第一杆件311、第二杆件312和第三杆件313分别与第一凸起331、第二凸起332和第三凸起333的位置轴向对应，能进一步对瓣叶交界处的位置进行补位，避免瓣叶交界处发生反流。In the first embodiment, the distal end of the
所述第一杆件311、第二杆件312和第三杆件313的游离端延伸至所述心房段31的外侧，并且，所述第一杆件311、第二杆件312和第三杆件313的游离端向所述支架1的远端方向弯曲以适于贴靠心房壁；由于瓣叶交界处的反流相对严重，因此第一杆件311、第二杆件312和第三杆件313的游离端延伸至心房段31的外侧，可与第一凸起331、第二凸起332和第三凸起333配合进一步对瓣叶交界处进行补位，使得密封装置3能填充到瓣叶交界处，避免反流的发生。The free ends of the
在本实施例一中，所述第一杆件311、第二杆件312和第三杆件313的游离端部分设有缓冲结构315，如图2c所示，其缓冲结构315不仅能避免戳伤心房壁，还能更好的顺应心房壁，达到良好的贴靠效果，避免出现缝隙，发生血液反流。In the first embodiment, the free ends of the
在本实施例一中，所述第一杆件311、第二杆件312和第三杆件313之间设有柔性裙边314；在三尖瓣假体安装就位后，第一杆件311、第二杆件312和第三杆件313贴靠心房壁，并且相邻的杆件之间有柔性的裙边314，柔性裙边314可以顺应并贴合心房壁。In the first embodiment, a
在本实施例一中，在自然状态下，所述心室段33的游离端向支架1的远端方向弯曲；心室段33的游离端与心房段31配合能紧紧抵住自体瓣环组织，有效增加密封装置3对自体瓣环的夹持力，实现更好的防漏效果。In the first embodiment, in a natural state, the free end of the
第二实施例second embodiment
实施例二与实施例一大体上相同。不同之处在于，本实施例二中，支架1的远端设有支撑杆6，其密封装置3的心房段31与支撑杆6固定连接。
一种具有密封装置3的三尖瓣假体，包括支架1、人工瓣叶2、密封装置3以及锚定件4，所述人工瓣叶2设置在支架1内，并且所述支架1的近端通过所述锚定件4固定在患者的室间隔组织上，所述密封装置3包括心房段31和心室段33，所述支架1的远端设有支撑杆6，其中，所述心房段31与所述支撑杆6固定连接，在所述支架1安装就位后，至少部分所述心房段31贴于心房壁，自体瓣环位于所述心房段31与心室段33之间，当心房壁挤压所述的密封装置3时，所述支撑杆6的游离端向所述支架1的中心靠拢，并带动所述心室段33向所述支架1的远端方向翻折并贴紧自体瓣环的下方，有效避免因心房挤压心房段31褶皱而出现缝隙，防止出现瓣周漏，如图4a和4b所示。A tricuspid valve prosthesis with a
在本实施例二中，三尖瓣假体还设有用于夹持自体瓣叶的夹持构件7。In the second embodiment, the tricuspid valve prosthesis is further provided with a clamping member 7 for clamping the native valve leaflet.
实施例二的其余构造和构思类似于实施例一，因此在这里不再重复描述。The rest of the structure and idea of the second embodiment are similar to the first embodiment, so no repeated description is given here.
以上内容仅为本申请的较佳实施例，对于本领域的普通技术人员，依据本申请的思想，在具体实施方式及应用范围上均会有改变之处，本说明书内容不应理解为对本申请的限制。The above content is only the preferred embodiment of the present application. For those of ordinary skill in the art, according to the thinking of the present application, there will be changes in the specific implementation and application scope. limits.
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