WO2022083027A1 - Adjustable and removable valve clamping device - Google Patents

Adjustable and removable valve clamping device Download PDF

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Publication number
WO2022083027A1
WO2022083027A1 PCT/CN2021/074688 CN2021074688W WO2022083027A1 WO 2022083027 A1 WO2022083027 A1 WO 2022083027A1 CN 2021074688 W CN2021074688 W CN 2021074688W WO 2022083027 A1 WO2022083027 A1 WO 2022083027A1
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WO
WIPO (PCT)
Prior art keywords
valve
clamping device
balloon body
valve clamping
anchor
Prior art date
Application number
PCT/CN2021/074688
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French (fr)
Chinese (zh)
Inventor
郭扬
Original Assignee
江苏臻亿医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN202022358481.7U external-priority patent/CN214049225U/en
Priority claimed from CN202011132835.4A external-priority patent/CN114376766A/en
Application filed by 江苏臻亿医疗科技有限公司 filed Critical 江苏臻亿医疗科技有限公司
Publication of WO2022083027A1 publication Critical patent/WO2022083027A1/en

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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

Definitions

  • the invention relates to the field of medical devices, in particular to an adjustable and removable valve clamping device.
  • the heart contains four chambers, the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). Throughout the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs simultaneously.
  • the valve that separates the atrium from the ventricle is called the atrioventricular valve.
  • the atrioventricular valve acts as a one-way valve to ensure the normal flow of blood in the heart chambers.
  • the atrioventricular valve between the left atrium and the left ventricle is the mitral valve
  • the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve.
  • the pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs; blood returns to the left atrium through the pulmonary veins.
  • the aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.
  • the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricle.
  • the atrioventricular valve opens to allow unobstructed flow from the atrium into the corresponding ventricle.
  • the tricuspid and mitral valves close normally, forming a seal that prevents backflow from the ventricle into the corresponding atrium.
  • the mitral valve anatomy is unique.
  • the mitral valve consists of a pair of cusps or leaflets, the anterior and posterior leaflets.
  • the cusps or leaflets extend down from the annulus into the left ventricle.
  • the mitral valve annulus can be formed into a "D" shape, oval or other non-round cross-sectional shape with major and minor axes.
  • the anterior leaflets may be larger than the posterior leaflets, forming a generally "C"-shaped boundary between the adjoining sides of the leaflets when the leaflets are closed together.
  • the mitral valve also includes the annulus, which is the dense annular fibrous tissue surrounding the valve leaflets. The mitral valve is anchored to the wall of the left ventricle by the chordae tendineae.
  • the chordae tendineae are the band-like tendons that connect the papillary muscles to the mitral valve leaflets.
  • the papillary muscles are used to limit motion of the mitral valve and prevent mitral valve recovery.
  • the mitral valve opens and closes in response to pressure changes in the left atrium and left ventricle.
  • the papillary muscles and the chordae tendineae are collectively known as the subvalvular mechanism, which functions to maintain the mitral valve from prolapse into the left atrium when the mitral valve is closed.
  • native valves can malfunction in two different ways, valve stenosis and valve regurgitation. Valvular stenosis occurs when the native valve does not open fully and thus results in a blockage of blood flow.
  • valve stenosis results from the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impair the valve's ability to fully open to allow positive blood flow.
  • Valve regurgitation is the incomplete closure of valve leaflets causing blood to leak back into the previous chamber.
  • the anterior and posterior leaflets together act as a one-way valve to allow blood to flow only from the left atrium to the left ventricle.
  • the left atrium receives oxygenated blood from the pulmonary veins.
  • the oxygenated blood collected in the left atrium flows into the left ventricle.
  • the left atrial muscle relaxes and the left ventricular muscle contracts, the elevated blood pressure in the left ventricle drives the sides of the two valve leaflets together, closing the one-way mitral valve so that blood cannot flow back to the left atrium, but instead through the main valve
  • the aortic valve drains from the left ventricle.
  • chordae tendineae tie the leaflets to the papillary muscles of the left ventricle.
  • Mitral regurgitation occurs when the mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systole of the heart. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, papillary muscle dysfunction, and/or left ventricular dilatation causing mitral annular stretch. Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, reduced blood flow, lower blood pressure, and/or reduced oxygen flow to body tissues. Mitral regurgitation can also cause blood to flow back from the left atrium to the pulmonary veins, causing congestion. Severe valve regurgitation, which, if left untreated, can lead to permanent disability or death.
  • Traditional valvular disease treatment methods include drug therapy and surgical methods with corresponding surgical indications. Among them, surgical methods also include valve replacement and valve repair. Among the surgical approaches, typical thoracotomy is too invasive, requires the establishment of cardiopulmonary bypass, and has a high complication rate and infection risk. Many patients cannot tolerate the huge surgical risk and can only wait for death.
  • transcatheter treatment method in which leaflet clamps are delivered to the mitral valve through a pushing device, and then the anterior and posterior leaflets of the mitral valve are simultaneously clamped by the relative opening of the clamps, so that the mitral valve is closed. The anterior and posterior leaflets are fixed to reduce mitral regurgitation.
  • the purpose of the present invention is to provide an adjustable and removable valve clamping device for solving the problems in the prior art.
  • the present invention provides an adjustable and removable valve clamping device, the valve clamping device includes a fixing portion and a spacer portion, the fixing portion includes a support, an anchor and a connection
  • the spacer includes a connected balloon body and a reducing valve, and the support piece, the anchor and the balloon body are all connected with the connecting piece.
  • the valve clamping device of the present invention has the following beneficial effects: it can be adapted to anatomical structures of different sizes, and can be re-intervened when the anatomical size around the mitral valve changes after surgery; the clamping distance and tension can be adjusted , can alleviate the reflux caused by postoperative left ventricular remodeling; each component provides a reliable clamping structure at the beginning of implantation, reducing reflux, and some structures can be degraded after a period of time after surgery, so as to provide transcatheter artificial valve replacement. Surgery, etc. provide space; can still be removed many years after implantation.
  • FIG. 1 is an overall schematic diagram of the valve holding device of the present invention.
  • FIG. 2 is a schematic diagram showing the fixing part of the valve clamping device of the present invention.
  • Figure 3 shows a schematic diagram of the valve holding device of the present invention.
  • FIG. 4 is a schematic diagram showing the valve holding device of the present invention in different situations with balloons of different sizes, wherein the lower figures are the top views of the upper figures.
  • Fig. 5 is a schematic diagram of clamping the native valve leaflet after the valve clamping device of the present invention is implanted.
  • FIG. 6 is a schematic diagram showing the degradation of the connector after the valve holding device of the present invention is implanted in the body for a period of time.
  • Fig. 7 is a schematic diagram showing the separation of the balloon body from the native valve leaflet during replacement surgery after the valve clamping device of the present invention is implanted into the body.
  • the present application provides a valve clamping device
  • the valve clamping device includes a fixing part 1 and a spacer part 2
  • the fixing part 1 includes a support member 11 , an anchor member 12 and a connecting member 13
  • the spacer 2 includes a balloon body 21, the proximal end of the balloon body 21 is provided with a reducing valve 22, the support member 11, the anchor 12 and the distal end of the balloon body 21 are all connected with the connecting member 13 Connected, the support member 11 and the anchor member 12 are opposite to form a valve clamping structure.
  • the proximal end refers to the end of the balloon body 21 that is not connected to the connector 13
  • the distal end refers to the end that is connected to the connector 13 .
  • the support member 11 includes a sealing layer 111 and a support frame 112 , and the sealing layer 111 is provided on the surface of the support frame 112 .
  • the sealing layer 111 is a sealing film.
  • the material of the sealing film is selected from biodegradable materials.
  • biodegradable materials For example, chitin, polymalic acid, polylactic acid, L-polylactic acid, etc.
  • the material of the sealing film is L-polylactic acid.
  • L-polylactic acid has high strength, good plasticity, easy processing and molding, biodegradable absorption, and good biocompatibility.
  • the sealing membrane 111 can constrain the overall shape of the support frame 112 at the initial stage of implantation of the valve clamping device, which can help the support frame 112 to maintain a fixed position during the implantation process. During the endothelialization process after implantation, the sealing membrane 111 is gradually hydrolyzed into Carbon dioxide and water, at this time, only the support frame 112 exists on the leaflets of the native valve.
  • both supporting frames 112 are connected with the connecting member 13 .
  • the two supporting frames 112 are symmetrically arranged on both sides of the connecting member 13 .
  • the material of the support frame 112 is selected from metal materials. Nitinol is preferred.
  • the support frame 112 is a skeleton woven from fine metal wires (only sparse metal wires are used for illustration in the figure).
  • the support frame 112 provides force for clamping and supporting the native leaflets.
  • the anchors 12 are provided in plural. For example, there are two, which can be used for mitral valve and tricuspid valve repair.
  • FIGS. 2 and 3 there are two anchors 12 , and the two anchors 12 are symmetrically arranged on both sides of the connecting piece 13 .
  • the anchors 12 are used to anchor the native leaflets.
  • the anchor 12 is provided with barbs.
  • the number of barbs may be 2 to 5.
  • One end of the anchor piece 12 is connected with the connecting piece 13 .
  • the support member 11 is arranged on the outer side
  • the anchor member 12 is arranged on the inner side.
  • the inner side refers to the side close to the spacer 2, that is, the side close to the central axis of the valve holding device.
  • the outer side refers to the side away from the spacer 2 , that is, the side away from the central axis of the valve clamping device.
  • the support 11 and the anchor 12 can cooperate to support the native valve leaflet together, that is, the support 11 is located on one side of the native valve leaflet, and the anchor 12 is located on the other side of the native valve leaflet, and the two are clamped on the original valve leaflet. on the original leaflets.
  • the material of the connector 13 is selected from biodegradable materials.
  • biodegradable materials for example, chitin, polymalic acid, polylactic acid, L-polylactic acid, etc.
  • the material of the connecting piece 13 is preferably L-polylactic acid.
  • L-polylactic acid has good biocompatibility after being degraded in the body, and is cheap and low in cost.
  • the balloon body 21 has openings up and down, the upper opening is provided with a diameter reducing valve 22 , and the lower opening of the balloon body 21 is sealedly connected with the connector 13 . After the connector 13 is degraded, the lower opening of the balloon body 21 is blocked by endothelialized tissue, so as to avoid leakage of the liquid in the balloon body.
  • the balloon body 21 and the fixing part 1 are located on the same side of the connecting member 13 , the support member 11 and the anchor member 12 are provided on both sides of the balloon body 21 , and the support The piece 11 is on the outside and the anchor is on the inside. That is, the balloon body 21 is disposed on the side of the connecting member 13 on which the fixing portion 1 is disposed, and is disposed between the anchors 12 .
  • the arrangement of the balloon body 21 enables the anchor element 12 and the support element 11 to clamp the valve and the balloon body 21 is positioned within the heart valve orifice, helping to fill the space and form a more effective seal.
  • the balloon body 21 has only one specification, but its size can be adjusted. As shown in FIG. 4 , balloon bodies 21 of different sizes are shown. Those skilled in the art know that the size of the balloon body 21 can be adjusted according to the actual situation of the patient.
  • the shape of the balloon body 21 is not particularly limited in the present invention, for example, it can be selected from ellipsoid, spindle and other shapes.
  • the material of the balloon body 21 is selected from flexible materials.
  • the balloon body 21 made of nylon elastomer flexible material can be compressed and introduced into the delivery system for auxiliary implantation during implantation. The size of the balloon body 21 is adjusted.
  • the diameter reducing valve 22 is connected with the fluid passage chamber of the delivery system for auxiliary implantation, and the size of the upper opening of the balloon body 21 can be adjusted by rotating the diameter reducing valve 22, so that the fluid passage chamber can be opened or closed.
  • Liquid eg, physiological saline
  • the reducing valve 22 is rotated, the balloon body 21 is closed, and the connection with the liquid-passing chamber is disconnected.
  • the volume of the balloon body 21 is determined according to different anatomical structures of the patient, such as the size of the valve annulus and the length of the valve leaflet. During surgery, the optimal size can be adjusted in real time according to the results of hemodynamic performance under ultrasound.
  • the use of the reducing valve 22 provides an interface for reintervention. After the level of regurgitation is reduced, there may be a reduction in the size of the left or right ventricle in the long and short axes, and the size of the annulus may be reduced due to the size of the valve leaflets themselves. It will not change with the size of the valve annulus or the ventricle. The size of the balloon body selected during the operation can no longer achieve the best therapeutic effect. At this time, it can be re-intervened. The diameter reducing valve 122 adjusts the volume of the solution in the balloon body 21 to fit the reconstructed anatomical structure.
  • the reducing valve 22 is selected from Tuohy Borst Adapter.
  • the diameter of the reducing valve 22 can be adjusted by rotating.
  • the support 11 and the anchor 12 clamp the prolapsed parts on the anterior and posterior leaflets of the mitral valve, and the septum 2 is filled in the heart valve, effectively eliminating or improving valve insufficiency.
  • the method significantly changes the geometry of the mitral valve to form a bi-portal mitral valve, improves leaflet coaptation, and reduces or eliminates valve regurgitation.
  • the spacer 2 can reduce the tension of the clamping part, avoid the tearing of the valve leaflets at the clamping part, and at the same time can provide a good seal and eliminate the central regurgitation.
  • the valve clamping device further includes an actuating portion 3, the actuating portion 3 includes an actuating wire 31 and an actuating wire 32, and the actuating wire 31 passes through the fixing portion 1 and the actuating wire 32.
  • the actuating wire 32 is connected to one end of the anchor 12 .
  • the actuating wire 31 is passed through the reducing valve 22 , the balloon body 21 and the connecting piece 13 .
  • the actuating wire 31 is used for positioning the fixing part 1 and the spacer part 2 . That is, the arrangement of the actuating wire 31 can achieve the purpose of adjusting the positions of the fixing portion 1 and the spacer portion 2 as a whole by moving the actuating wire 31 during implantation.
  • the septum 2 is located between the original leaflet and the leaflet.
  • the actuation wire is a metal wire.
  • the metal wire has a certain hardness. When the metal wire is moved, the balloon body 21 and the connecting piece 13 connected in series can be moved conveniently, quickly and accurately, and then the support piece 11 and the anchor piece 12 can be moved.
  • the actuation wire 32 is connected to the barbed end of the anchor 12 .
  • the movement of the anchor 12 can be controlled by adjusting the actuation wire 32 to move the anchor 12 closer to or away from the native leaflets, thereby capturing or separating the native leaflets.
  • the valve holding device of the present invention can be used for the repair of heart valves. Such as mitral valve, tricuspid valve repair.
  • a delivery system is required to assist the implantation of the valve holding device, and the delivery system includes a delivery sheath, a fluid passage, and a fluid passage catheter.
  • the method of using the valve clamping device of the present invention is as follows: the balloon body 21 , the reducing valve 22 and the actuating wire 31 have been assembled before leaving the factory, and the anchor 12 is provided with a barbed end to connect the actuating wire 32 .
  • the anchor 12 is provided with a barbed end to connect the actuating wire 32 .
  • the reducing valve 22 When in use, it is not necessary to select the specifications of the balloon body 21 according to the patient's condition, connect the reducing valve 22 to the fluid-passage conduit, inject and aspirate the liquid to empty and fold the balloon body 21, and push the actuating wire 31 to fix the fixed part. 1 and the spacer 2 are axially stretched so that they are radially compressed and introduced into the delivery sheath.
  • both actuation wires 32 can open the anchors 12 individually or simultaneously to capture the leaflets.
  • the actuating wire 31 is moved along the axial direction of the actuating wire 31, thereby driving the fixing part 1 and the spacer part 2, the support frame 112 is arranged on the lower side of the valve leaflet, and the anchor 12 is arranged on the upper side of the valve leaflet, using
  • the actuation wire 32 makes the anchor 12 anchor the native valve leaflets, and the balloon body 21 is arranged between the native valve leaflets (as shown in FIG. 5 , the component between the anchor 12 and the support frame 112 in the figure is the native valve leaflet) .
  • the initial state of the reducing valve 22 is the open state, inject a suitable volume of liquid into the balloon body 21 through the liquid passage cavity, adjust the volume of the balloon body 21, and use an imaging device such as transesophageal ultrasound to confirm the reflux situation.
  • the actuating wire 31 is rotated to disengage the actuating wire 31 from the connector 13 , and the actuating wire 31 is withdrawn from the balloon body 21 and the reducing valve 22 in sequence.
  • the actuation wire 32 is cut and withdrawn.
  • Rotate the liquid-passing cavity catheter adjust the reducing valve 22 from the initial open state to the blocking state, withdraw the liquid-passing cavity catheter, and complete the release of the valve clamping device. After completing the implantation of the valve holding device, it can effectively reduce mitral regurgitation or tricuspid regurgitation.
  • the sealing layer 111 and the connecting member 13 will gradually degrade after implantation, and finally, only the support frame fixed on the original valve leaflet remains in the valve clamping device 112, the anchor 12 and the balloon body 21 (Fig. 6).
  • a delivery system without a valve holding device can be sent into the implantation site, with the aid of a snare or other tools, the reducing valve 22 is connected, the balloon body 21 is fixed, and the balloon body 21 All the liquid inside is sucked out of the body; use the radio frequency electrode catheter to cut the adhesion between the balloon body 21 and the native valve leaflet until the two are separated (as shown in Figure 7).
  • the septum 2 is withdrawn, and then the artificial valve is replaced, so as to further improve the quality of life of the patient and prolong the life of the patient.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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  • Prostheses (AREA)

Abstract

An adjustable and removable valve clamping device, comprising a fixing part (1) and a spacing part (2). The fixing part (1) comprises a supporting member (11), an anchoring member (12), and a connecting member (13); the spacing part (2) comprises a balloon body (21) and a diameter-changing valve (22) which are connected; and the supporting member (11), the anchoring member (12), and the balloon body (21) are all connected to the connecting member (13). The valve clamping device can be adaptive to anatomical structures of various nonlinear dimensions, so that the range of indications is expanded; after the anatomical dimension around the mitral valve is changed after an operation, a re-intervention interface is provided, and the clamping distance and tension are adjusted, so that regurgitation caused by left ventricular reconstruction after the operation is relieved, and the treatment effect is further prolonged; the parts provide reliable clamping structures at the beginning of implantation, regurgitation is reduced, some of the structures can be degraded after a period of time after the operation, and space is provided for replacement and other treatment means possibly needed by long-term prognosis.

Description

一种可调节可移除的瓣膜夹持装置An adjustable and removable valve clamping device 技术领域technical field
本发明涉及医疗器械领域，特别是涉及一种可调节可移除的瓣膜夹持装置。The invention relates to the field of medical devices, in particular to an adjustable and removable valve clamping device.
背景技术Background technique
心脏含有四个腔室，右心房(RA)、右心室(RV)、左心房(LA)和左心室(LV)。在整个心动周期中，心脏的左、右两侧的泵送作用一般同步发生。将心房与心室分开的瓣膜被称为房室瓣，房室瓣起到单向阀的作用，保证心腔内血液的正常流动。左心房与左心室之间的房室瓣是二尖瓣，右心房与右心室之间的房室瓣是三尖瓣。肺动脉瓣将血流导向肺动脉，并从那里流向肺部；血液通过肺静脉返回左心房。主动脉瓣引导血流通过主动脉并从那里流向周边。通常在心室之间或心房之间没有直接连接。在心室充盈(舒张)开始时，主动脉瓣和肺动脉瓣关闭，以防止从动脉进入心室的回流。此后不久，房室瓣打开以允许从心房进入相应心室的无阻碍流动。在心室收缩期开始后不久，三尖瓣和二尖瓣正常关闭，从而形成防止从心室回流进入相应心房的密封。The heart contains four chambers, the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). Throughout the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs simultaneously. The valve that separates the atrium from the ventricle is called the atrioventricular valve. The atrioventricular valve acts as a one-way valve to ensure the normal flow of blood in the heart chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs; blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria. At the onset of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricle. Shortly thereafter, the atrioventricular valve opens to allow unobstructed flow from the atrium into the corresponding ventricle. Shortly after the onset of ventricular systole, the tricuspid and mitral valves close normally, forming a seal that prevents backflow from the ventricle into the corresponding atrium.
二尖瓣解剖结构具有特殊性。二尖瓣包括一对尖瓣或瓣叶，即前叶和后叶。尖瓣或瓣叶从瓣环向下延伸到左心室中。二尖瓣环可形成“D”形、卵圆形或其他不圆的具有长轴和短轴的横截面形状。前叶可以比后叶更大，在瓣叶闭合在一起时在瓣叶的毗连侧之间形成大致“C”形的边界。二尖瓣还包括瓣环，瓣环是围绕瓣叶的致密纤维环组织。二尖瓣通过腱索锚固至左心室的壁。腱索是将***肌连接到二尖瓣瓣叶的带状腱。***肌用于限制二尖瓣的运动和防止二尖瓣复原。二尖瓣响应左心房和左心室的压力变化打开和闭合。***肌和腱索一起被称为瓣下机构，其作用为当二尖瓣闭合时维持二尖瓣不脱垂到左心房中。总体上，原生瓣膜可以两种不同的方式发生机能不良，瓣膜狭窄和瓣膜反流。瓣膜狭窄在天然瓣膜不完全打开并从而导致血流阻塞时发生。一般，瓣膜狭窄是钙化物质在瓣膜瓣叶上的积累造成的，这导致瓣叶增厚并削弱瓣膜完全打开以允许正向血液流动的能力。瓣膜反流是瓣膜瓣叶不完全闭合从而导致血液泄漏回先前的腔室。The mitral valve anatomy is unique. The mitral valve consists of a pair of cusps or leaflets, the anterior and posterior leaflets. The cusps or leaflets extend down from the annulus into the left ventricle. The mitral valve annulus can be formed into a "D" shape, oval or other non-round cross-sectional shape with major and minor axes. The anterior leaflets may be larger than the posterior leaflets, forming a generally "C"-shaped boundary between the adjoining sides of the leaflets when the leaflets are closed together. The mitral valve also includes the annulus, which is the dense annular fibrous tissue surrounding the valve leaflets. The mitral valve is anchored to the wall of the left ventricle by the chordae tendineae. The chordae tendineae are the band-like tendons that connect the papillary muscles to the mitral valve leaflets. The papillary muscles are used to limit motion of the mitral valve and prevent mitral valve recovery. The mitral valve opens and closes in response to pressure changes in the left atrium and left ventricle. The papillary muscles and the chordae tendineae are collectively known as the subvalvular mechanism, which functions to maintain the mitral valve from prolapse into the left atrium when the mitral valve is closed. In general, native valves can malfunction in two different ways, valve stenosis and valve regurgitation. Valvular stenosis occurs when the native valve does not open fully and thus results in a blockage of blood flow. Generally, valve stenosis results from the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impair the valve's ability to fully open to allow positive blood flow. Valve regurgitation is the incomplete closure of valve leaflets causing blood to leak back into the previous chamber.
对于正常的二尖瓣膜，前叶和后叶一起充当单向瓣膜，以允许血液仅从左心房流到左心室。左心房接收来自肺静脉的含氧血。当左心房肌肉收缩并且左心室舒张时，左心房中收集的含氧血液流入左心室。当左心房肌肉松弛并且左心室肌肉收缩时，左心室的升高血压将两个瓣叶的两侧驱使在一起，从而闭合单向二尖瓣，使得血液不能流回左心房，而是通过主动脉瓣从左心室排出。为了防止两个瓣叶在压力下脱出并朝向左心房反向折叠通过二尖瓣环， 多条纤维索(被称为腱索)将瓣叶系于左心室的***肌。With a normal mitral valve, the anterior and posterior leaflets together act as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrium muscle contracts and the left ventricle relaxes, the oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricular muscle contracts, the elevated blood pressure in the left ventricle drives the sides of the two valve leaflets together, closing the one-way mitral valve so that blood cannot flow back to the left atrium, but instead through the main valve The aortic valve drains from the left ventricle. To prevent the two leaflets from dislodging under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords (called chordae tendineae) tie the leaflets to the papillary muscles of the left ventricle.
当二尖瓣未能正常关闭并且血液在心脏收缩的收缩期从左心室流入左心房时，发生二尖瓣反流。二尖瓣反流是瓣膜心脏疾病的最常见形式。二尖瓣反流有不同的原因，如瓣叶脱垂、***肌功能失调和/或左心室扩张引起二尖瓣环拉伸。心脏瓣膜关闭不全可对患者产生严重的后果，往往导致心脏衰竭、减少血流量、降低血压，和/或减少到达人体组织的氧流量。二尖瓣关闭不全还可引起血液从左心房流回肺静脉，从而造成充血。严重的瓣膜关闭不全，如果不进行治疗，可导致永久性残疾或死亡。Mitral regurgitation occurs when the mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systole of the heart. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, papillary muscle dysfunction, and/or left ventricular dilatation causing mitral annular stretch. Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, reduced blood flow, lower blood pressure, and/or reduced oxygen flow to body tissues. Mitral regurgitation can also cause blood to flow back from the left atrium to the pulmonary veins, causing congestion. Severe valve regurgitation, which, if left untreated, can lead to permanent disability or death.
传统的瓣膜疾病治疗手段包括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。很多患者耐受不了巨大的外科风险而只能无奈等待死亡。现有一种经导管治疗的方法，将瓣叶夹钳通过推送装置输送至二尖瓣处，再通过夹钳的相对开合同时夹住二尖瓣的前叶和后叶，使得二尖瓣的前叶与后叶固定从而达到减少二尖瓣反流的目的。Traditional valvular disease treatment methods include drug therapy and surgical methods with corresponding surgical indications. Among them, surgical methods also include valve replacement and valve repair. Among the surgical approaches, typical thoracotomy is too invasive, requires the establishment of cardiopulmonary bypass, and has a high complication rate and infection risk. Many patients cannot tolerate the huge surgical risk and can only wait for death. There is an existing transcatheter treatment method, in which leaflet clamps are delivered to the mitral valve through a pushing device, and then the anterior and posterior leaflets of the mitral valve are simultaneously clamped by the relative opening of the clamps, so that the mitral valve is closed. The anterior and posterior leaflets are fixed to reduce mitral regurgitation.
虽然用于二尖瓣瓣膜修复的夹持类产品在不断优化升级，但是仍然存在一些改进的空间，比如：Although the clamping products for mitral valve repair are constantly being optimized and upgraded, there is still some room for improvement, such as:
1、由于二尖瓣反流的原因复杂多样，且患者的年龄、性别、人种、体重等差异引起的二尖瓣附近的解剖结构尺寸差别较大，而现有二尖瓣夹合器产品的尺寸型号有限，所以无法实现每位患者都得到最匹配的产品配置，这会影响手术效果。1. Due to the complex and diverse causes of mitral valve regurgitation, and the differences in the patient's age, gender, race, weight, etc., the size of the anatomical structure near the mitral valve is quite different, and the existing mitral valve clamp products There are limited sizes and models, so it is impossible to achieve the most matching product configuration for each patient, which will affect the surgical effect.
2、研究表明功能性二尖瓣反流发作后，许多患者会出现左心室扩大的症状，在行二尖瓣钳夹术后，由于反流情况得到缓解，原本扩张的左心室尺寸会发生变化，即左心室长轴和短轴的长度、瓣环直径、瓣叶夹合处的应力应变均会产生变化，这种现象可能导致反流情况重新出现，严重的需要再次进行手术干预。现有技术中夹合器植入后形成了双孔结构，无法实现微创方式(如经导管人工瓣膜置换等手术)的再次干预。2. Studies have shown that after the onset of functional mitral regurgitation, many patients will have symptoms of left ventricular enlargement. After mitral valve clamping, the size of the originally dilated left ventricle will change due to the relief of the regurgitation. , that is, the length of the long and short axes of the left ventricle, the diameter of the valve annulus, and the stress and strain at the leaflet clip will all change. This phenomenon may lead to the recurrence of regurgitation, and severe surgical intervention is required. In the prior art, a double-hole structure is formed after the clamp is implanted, and re-intervention by a minimally invasive method (such as transcatheter artificial valve replacement and other operations) cannot be realized.
发明内容SUMMARY OF THE INVENTION
鉴于以上所述现有技术的缺点，本发明的目的在于提供一种可调节可移除的瓣膜夹持装置，用于解决现有技术中的问题。In view of the above-mentioned disadvantages of the prior art, the purpose of the present invention is to provide an adjustable and removable valve clamping device for solving the problems in the prior art.
为实现上述目的及其他相关目的，本发明提供一种可调节可移除的瓣膜夹持装置，所述瓣膜夹持装置包括固定部和间隔部，所述固定部包括支撑件、锚固件和连接件，所述间隔部包括相连的球囊体和变径阀，所述支撑件、锚固件和球囊体均与连接件连接。In order to achieve the above object and other related objects, the present invention provides an adjustable and removable valve clamping device, the valve clamping device includes a fixing portion and a spacer portion, the fixing portion includes a support, an anchor and a connection The spacer includes a connected balloon body and a reducing valve, and the support piece, the anchor and the balloon body are all connected with the connecting piece.
如上所述，本发明的瓣膜夹持装置，具有以下有益效果：可适配不同尺寸的解剖结构，并且可以在术后二尖瓣周围解剖尺寸发生变化的时候再次介入；调整夹合距离和张力，可以缓解术后左室重构造成的反流；各部件在植入之初提供可靠的夹合结构、降低反流，部分结构可以在术后一段时间之后降解，从而为经导管人工瓣膜置换手术等提供空间；在植入多年后仍可以被移除。As mentioned above, the valve clamping device of the present invention has the following beneficial effects: it can be adapted to anatomical structures of different sizes, and can be re-intervened when the anatomical size around the mitral valve changes after surgery; the clamping distance and tension can be adjusted , can alleviate the reflux caused by postoperative left ventricular remodeling; each component provides a reliable clamping structure at the beginning of implantation, reducing reflux, and some structures can be degraded after a period of time after surgery, so as to provide transcatheter artificial valve replacement. Surgery, etc. provide space; can still be removed many years after implantation.
附图说明Description of drawings
图1显示为本发明的瓣膜夹持装置的整体示意图。FIG. 1 is an overall schematic diagram of the valve holding device of the present invention.
图2显示为本发明的瓣膜夹持装置固定部的示意图。FIG. 2 is a schematic diagram showing the fixing part of the valve clamping device of the present invention.
图3显示为本发明的瓣膜夹持装置的示意图。Figure 3 shows a schematic diagram of the valve holding device of the present invention.
图4显示为本发明的瓣膜夹持装置在不同情境下不同尺寸球囊体的示意图，其中下方的各图为上方各图的俯视图。FIG. 4 is a schematic diagram showing the valve holding device of the present invention in different situations with balloons of different sizes, wherein the lower figures are the top views of the upper figures.
图5显示为本发明的瓣膜夹持装置植入完毕后夹合原生瓣叶的示意图。Fig. 5 is a schematic diagram of clamping the native valve leaflet after the valve clamping device of the present invention is implanted.
图6显示为本发明的瓣膜夹持装置植入体内一段时间后连接件降解后的示意图。FIG. 6 is a schematic diagram showing the degradation of the connector after the valve holding device of the present invention is implanted in the body for a period of time.
图7显示为本发明的瓣膜夹持装置植入体内后，进行置换手术时将球囊体与原生瓣叶分离后的示意图。Fig. 7 is a schematic diagram showing the separation of the balloon body from the native valve leaflet during replacement surgery after the valve clamping device of the present invention is implanted into the body.
元件标号说明Component label description
1                      固定部1 Fixed part
11                     支撑件11 Supports
111                    密封层111 Sealing layer
112                    支撑架112 Support frame
12                     锚固件12 Anchors
13                     连接件13 Connectors
2                      间隔部2 Spacer
21                     球囊体21 Balloon body
22                     变径阀22 Reducer valve
3                      致动部3 Actuating part
31                     致动丝31 Actuating wire
32                     致动线32 Actuating wire
具体实施方式Detailed ways
以下由特定的具体实施例说明本发明的实施方式，熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效。The embodiments of the present invention are described below by specific embodiments, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.
请参阅图1至图7。须知，本说明书所附图式所绘示的结构、比例、大小等，均仅用以配合说明书所揭示的内容，以供熟悉此技术的人士了解与阅读，并非用以限定本发明可实施的限定条件，故不具技术上的实质意义，任何结构的修饰、比例关系的改变或大小的调整，在不影响本发明所能产生的功效及所能达成的目的下，均应仍落在本发明所揭示的技术内容能涵盖的范围内。同时，本说明书中所引用的如“上”、“下”、“左”、“右”、“中间”及“一”等的用语，亦仅为便于叙述的明了，而非用以限定本发明可实施的范围，其相对关系的改变或调整，在无实质变更技术内容下，当亦视为本发明可实施的范畴。See Figures 1 through 7. It should be noted that the structures, proportions, sizes, etc. shown in the drawings in this specification are only used to cooperate with the contents disclosed in the specification, so as to be understood and read by those who are familiar with the technology, and are not used to limit the implementation of the present invention. Restricted conditions, it does not have technical substantive significance, any structural modification, proportional relationship change or size adjustment, without affecting the effect that the present invention can produce and the purpose that can be achieved, should still fall within the present invention. The disclosed technical content can cover the scope. At the same time, the terms such as "up", "down", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and clarity, and are not used to limit this specification. The implementable scope of the invention, and the change or adjustment of the relative relationship thereof, shall also be regarded as the implementable scope of the present invention without substantially changing the technical content.
如图1-7所示，本申请提供一种瓣膜夹持装置，所述瓣膜夹持装置包括固定部1和间隔部2，所述固定部1包括支撑件11、锚固件12和连接件13，所述间隔部2包括球囊体21，所述球囊体21的近端设有变径阀22，所述支撑件11、锚固件12以及球囊体21的远端均与连接件13连接，所述支撑件11与锚固件12相对形成瓣膜夹持结构。As shown in FIGS. 1-7 , the present application provides a valve clamping device, the valve clamping device includes a fixing part 1 and a spacer part 2 , and the fixing part 1 includes a support member 11 , an anchor member 12 and a connecting member 13 . , the spacer 2 includes a balloon body 21, the proximal end of the balloon body 21 is provided with a reducing valve 22, the support member 11, the anchor 12 and the distal end of the balloon body 21 are all connected with the connecting member 13 Connected, the support member 11 and the anchor member 12 are opposite to form a valve clamping structure.
所述近端是指球囊体21不与连接件13连接的一端，远端是指与连接件13连接的一端。The proximal end refers to the end of the balloon body 21 that is not connected to the connector 13 , and the distal end refers to the end that is connected to the connector 13 .
如图2所示，所述支撑件11包括密封层111和支撑架112，所述密封层111设于支撑架112表面。As shown in FIG. 2 , the support member 11 includes a sealing layer 111 and a support frame 112 , and the sealing layer 111 is provided on the surface of the support frame 112 .
在一种实施方式中，所述密封层111为密封膜。In one embodiment, the sealing layer 111 is a sealing film.
在一种实施方式中，所述密封膜的材料选自生物可降解材料。例如甲壳素、聚苹果酸、聚乳酸、左旋聚乳酸等。在一较佳实施方式中所述密封膜的材料为左旋聚乳酸。左旋聚乳酸强度高、可塑性好、易加工成型，可生物降解吸收、具有良好的生物相容性。密封膜111在瓣膜夹持装置植入初期可约束支撑架112整体的形状，可以帮助支撑架112在植入过程中保持固定位置，在植入后的内皮化过程中，密封膜111逐渐水解成二氧化碳和水，此时原生瓣膜的瓣叶上只存在支撑架112。In one embodiment, the material of the sealing film is selected from biodegradable materials. For example, chitin, polymalic acid, polylactic acid, L-polylactic acid, etc. In a preferred embodiment, the material of the sealing film is L-polylactic acid. L-polylactic acid has high strength, good plasticity, easy processing and molding, biodegradable absorption, and good biocompatibility. The sealing membrane 111 can constrain the overall shape of the support frame 112 at the initial stage of implantation of the valve clamping device, which can help the support frame 112 to maintain a fixed position during the implantation process. During the endothelialization process after implantation, the sealing membrane 111 is gradually hydrolyzed into Carbon dioxide and water, at this time, only the support frame 112 exists on the leaflets of the native valve.
在一种实施方式中，所述支撑架112设有多个。例如所述支撑架112设有两个，可用于二尖瓣、三尖瓣的修复。In one embodiment, there are multiple supporting frames 112 . For example, there are two supporting frames 112, which can be used for the repair of the mitral valve and the tricuspid valve.
在如图2和3所示的实施方式中，所述支撑架112设有两个，两个支撑架112均与连接件13连接。两个支撑架112在连接件13两侧对称设置。In the embodiment shown in FIGS. 2 and 3 , there are two supporting frames 112 , and both supporting frames 112 are connected with the connecting member 13 . The two supporting frames 112 are symmetrically arranged on both sides of the connecting member 13 .
在一种实施方式中，所述支撑架112的材料选自金属材料。优选镍钛合金。In one embodiment, the material of the support frame 112 is selected from metal materials. Nitinol is preferred.
在一种实施方式中，所述支撑架112为由细密的金属丝编织而成的骨架(图中仅用稀疏 的金属丝示意)。所述支撑架112为夹合和支撑原生瓣叶提供作用力。In one embodiment, the support frame 112 is a skeleton woven from fine metal wires (only sparse metal wires are used for illustration in the figure). The support frame 112 provides force for clamping and supporting the native leaflets.
所述锚固件12设有多个。例如设有两个，可用于二尖瓣、三尖瓣的修复。The anchors 12 are provided in plural. For example, there are two, which can be used for mitral valve and tricuspid valve repair.
在如图2和3所示的实施方式中，所述锚固件12设有两个，两个锚固件12在连接件13两侧呈对称设置。In the embodiment shown in FIGS. 2 and 3 , there are two anchors 12 , and the two anchors 12 are symmetrically arranged on both sides of the connecting piece 13 .
所述锚固件12用于锚固原生瓣叶。在一种实施方式中，所述锚固件12上设有倒刺。倒刺的数目可以是2～5个。The anchors 12 are used to anchor the native leaflets. In one embodiment, the anchor 12 is provided with barbs. The number of barbs may be 2 to 5.
所述锚固件12一端与连接件13连接。One end of the anchor piece 12 is connected with the connecting piece 13 .
进一步的，所述支撑件11设于外侧，所述锚固件12设于内侧。所述内侧是指靠近所述间隔部2的一侧，即靠近所述瓣膜夹持装置中轴线的一侧。所述外侧是指远离所述间隔部2的一侧，即远离所述瓣膜夹持装置中轴线的一侧。植入后，所述支撑件11和锚固件12配合可以共同支撑原生瓣叶，即支撑件11位于原生瓣叶的一侧，锚固件12位于原生瓣叶的另一侧，二者夹合于原生瓣叶上。Further, the support member 11 is arranged on the outer side, and the anchor member 12 is arranged on the inner side. The inner side refers to the side close to the spacer 2, that is, the side close to the central axis of the valve holding device. The outer side refers to the side away from the spacer 2 , that is, the side away from the central axis of the valve clamping device. After implantation, the support 11 and the anchor 12 can cooperate to support the native valve leaflet together, that is, the support 11 is located on one side of the native valve leaflet, and the anchor 12 is located on the other side of the native valve leaflet, and the two are clamped on the original valve leaflet. on the original leaflets.
在一种实施方式中，所述连接件13的材料选自生物可降解材料。例如甲壳素、聚苹果酸、聚乳酸、左旋聚乳酸等。所述连接件13的材料优选为左旋聚乳酸。左旋聚乳酸在体内降解后的生物相容性好，且价格便宜成本较低。植入后，所述连接件13降解后，原生瓣叶上只留存极细金属丝的支撑架112和锚固件12，且原生瓣叶与原生瓣叶之间无硬质材料连接，只能通过内皮化组织相连。In one embodiment, the material of the connector 13 is selected from biodegradable materials. For example, chitin, polymalic acid, polylactic acid, L-polylactic acid, etc. The material of the connecting piece 13 is preferably L-polylactic acid. L-polylactic acid has good biocompatibility after being degraded in the body, and is cheap and low in cost. After implantation, after the connector 13 is degraded, only the support frame 112 and the anchor 12 of the ultra-fine metal wires are left on the native valve leaflet, and there is no hard material connection between the native valve leaflet and the native valve leaflet, and can only pass through the original valve leaflet. Endothelial tissue is connected.
在如图3所示的实施方式中，所述球囊体21上下均有开口，上开口处设有变径阀22，球囊体21的下开口处与连接件13密封连接。连接件13降解之后球囊体21的下开口通过内皮化组织封堵，避免球囊体内的液体漏出。In the embodiment shown in FIG. 3 , the balloon body 21 has openings up and down, the upper opening is provided with a diameter reducing valve 22 , and the lower opening of the balloon body 21 is sealedly connected with the connector 13 . After the connector 13 is degraded, the lower opening of the balloon body 21 is blocked by endothelialized tissue, so as to avoid leakage of the liquid in the balloon body.
所述球囊体21与所述固定部1位于所述连接件13的同一侧，所述球囊体21的两侧均设有所述支撑件11和所述锚固件12，且所述支撑件11位于外侧，所述锚固件位于内侧。亦即，所述球囊体21设于连接件13上设有固定部1的一侧且设于各锚固件12之间。The balloon body 21 and the fixing part 1 are located on the same side of the connecting member 13 , the support member 11 and the anchor member 12 are provided on both sides of the balloon body 21 , and the support The piece 11 is on the outside and the anchor is on the inside. That is, the balloon body 21 is disposed on the side of the connecting member 13 on which the fixing portion 1 is disposed, and is disposed between the anchors 12 .
所述球囊体21的设置使锚固件12和支撑件11夹持瓣膜后球囊体21被定位在心脏瓣口内，有助于填充空间并形成更有效的密封。The arrangement of the balloon body 21 enables the anchor element 12 and the support element 11 to clamp the valve and the balloon body 21 is positioned within the heart valve orifice, helping to fill the space and form a more effective seal.
所述球囊体21只有一种规格，但其尺寸可以调节，如图4所示为不同尺寸的球囊体21。本领域技术人员均知悉，球囊体21的尺寸根据患者的实际情况调节即可。The balloon body 21 has only one specification, but its size can be adjusted. As shown in FIG. 4 , balloon bodies 21 of different sizes are shown. Those skilled in the art know that the size of the balloon body 21 can be adjusted according to the actual situation of the patient.
所述球囊体21的形状本发明不做特别限定，例如可以选自椭球形、纺锤形等形态。The shape of the balloon body 21 is not particularly limited in the present invention, for example, it can be selected from ellipsoid, spindle and other shapes.
所述球囊体21的材料选自柔性材料。例如尼龙弹性体柔性材料制成的球囊体21可以在植入时被压缩导入辅助植入的递送***中，被递送***释放后球囊体21又可以扩张，而且可 以根据不同患者的实际情况调节球囊体21的大小。The material of the balloon body 21 is selected from flexible materials. For example, the balloon body 21 made of nylon elastomer flexible material can be compressed and introduced into the delivery system for auxiliary implantation during implantation. The size of the balloon body 21 is adjusted.
所述变径阀22与辅助植入的递送***的通液腔相连，可以通过旋转变径阀22调节所述球囊体21的上开口尺寸，使通液腔被打开或关闭。经由所述变径阀22向球囊体21内注入液体(如生理盐水)，通过注射液体的容量，调节所述球囊体21的体积。注入完毕后旋转变径阀22，球囊体21关闭，与通液腔断开连接。The diameter reducing valve 22 is connected with the fluid passage chamber of the delivery system for auxiliary implantation, and the size of the upper opening of the balloon body 21 can be adjusted by rotating the diameter reducing valve 22, so that the fluid passage chamber can be opened or closed. Liquid (eg, physiological saline) is injected into the balloon body 21 through the diameter reducing valve 22 , and the volume of the balloon body 21 is adjusted by the volume of the injected liquid. After the injection is completed, the reducing valve 22 is rotated, the balloon body 21 is closed, and the connection with the liquid-passing chamber is disconnected.
所述球囊体21的体积根据患者的不同瓣环尺寸、瓣叶长度等解剖结构决定。在手术过程中，可以随时根据超声下的血流动力学性能结果实时调节至最佳尺寸。The volume of the balloon body 21 is determined according to different anatomical structures of the patient, such as the size of the valve annulus and the length of the valve leaflet. During surgery, the optimal size can be adjusted in real time according to the results of hemodynamic performance under ultrasound.
变径阀22的使用为再介入提供了接口，在反流等级降低后，左心室或右心室长轴和短轴的尺寸可能出现缩小，瓣环尺寸可能会变小，由于瓣叶本身的尺寸不会随着瓣环或心室尺寸发生变化，手术时选定的球囊体尺寸已经不再能实现最佳的治疗效果，此时可以再次介入，将通液腔与变径阀22连接，打开变径阀122，调整球囊体21中溶液的体积，适配重构后的解剖结构。The use of the reducing valve 22 provides an interface for reintervention. After the level of regurgitation is reduced, there may be a reduction in the size of the left or right ventricle in the long and short axes, and the size of the annulus may be reduced due to the size of the valve leaflets themselves. It will not change with the size of the valve annulus or the ventricle. The size of the balloon body selected during the operation can no longer achieve the best therapeutic effect. At this time, it can be re-intervened. The diameter reducing valve 122 adjusts the volume of the solution in the balloon body 21 to fit the reconstructed anatomical structure.
在一种实施方式中，所述变径阀22选自Tuohy Borst Adapter。该变径阀22可通过旋转调节口径大小。In one embodiment, the reducing valve 22 is selected from Tuohy Borst Adapter. The diameter of the reducing valve 22 can be adjusted by rotating.
植入后，支撑件11和锚固件12将二尖瓣叶前叶和后叶上的脱垂部分夹合起来，间隔部2填充于心脏瓣口内，有效消除或改善了瓣膜关闭不全，这种方式明显地改变了二尖瓣的几何形态，形成一个双孔二尖瓣，改善了瓣叶的对合，减轻或消除了瓣膜的反流。间隔部2可以减少夹合部位的张力，避免夹合处瓣叶撕裂，同时可以提供良好的密封，消除中心反流。After implantation, the support 11 and the anchor 12 clamp the prolapsed parts on the anterior and posterior leaflets of the mitral valve, and the septum 2 is filled in the heart valve, effectively eliminating or improving valve insufficiency. The method significantly changes the geometry of the mitral valve to form a bi-portal mitral valve, improves leaflet coaptation, and reduces or eliminates valve regurgitation. The spacer 2 can reduce the tension of the clamping part, avoid the tearing of the valve leaflets at the clamping part, and at the same time can provide a good seal and eliminate the central regurgitation.
在一种实施例中，所述瓣膜夹持装置还包括致动部3，所述致动部3包括致动丝31和致动线32，所述致动丝31穿设于固定部1和间隔部2中，所述致动线32与锚固件12的一端连接。In one embodiment, the valve clamping device further includes an actuating portion 3, the actuating portion 3 includes an actuating wire 31 and an actuating wire 32, and the actuating wire 31 passes through the fixing portion 1 and the actuating wire 32. In the spacer 2 , the actuating wire 32 is connected to one end of the anchor 12 .
具体的，所述致动丝31穿设于变径阀22、球囊体21中直至连接件13。所述致动丝31用于定位固定部1和间隔部2。亦即，致动丝31的设置方式可以实现植入时通过移动致动丝31从而达到能整体调整固定部1和间隔部2位置的目的，植入完毕时使固定部1的支撑件11位于原生瓣叶下侧，使间隔部2位于原生瓣叶与瓣叶之间。Specifically, the actuating wire 31 is passed through the reducing valve 22 , the balloon body 21 and the connecting piece 13 . The actuating wire 31 is used for positioning the fixing part 1 and the spacer part 2 . That is, the arrangement of the actuating wire 31 can achieve the purpose of adjusting the positions of the fixing portion 1 and the spacer portion 2 as a whole by moving the actuating wire 31 during implantation. On the lower side of the original leaflet, the septum 2 is located between the original leaflet and the leaflet.
在一种实施方式中，所述致动丝为金属丝。金属丝有一定硬度，移动金属丝时可以方便迅速准确的移动其上串联的球囊体21和连接件13，再带动支撑件11、锚固件12移动。In one embodiment, the actuation wire is a metal wire. The metal wire has a certain hardness. When the metal wire is moved, the balloon body 21 and the connecting piece 13 connected in series can be moved conveniently, quickly and accurately, and then the support piece 11 and the anchor piece 12 can be moved.
在一种实施方式中，所述致动线32与锚固件12设有倒刺的一端连接。植入时，可以通过调整致动线32控制锚固件12运动，使锚固件12靠近或远离原生瓣叶，从而使其捕获原生瓣叶或与原生瓣叶分离。In one embodiment, the actuation wire 32 is connected to the barbed end of the anchor 12 . During implantation, the movement of the anchor 12 can be controlled by adjusting the actuation wire 32 to move the anchor 12 closer to or away from the native leaflets, thereby capturing or separating the native leaflets.
本发明的瓣膜夹持装置可用于心脏瓣膜的修复。例如二尖瓣、三尖瓣的修复。The valve holding device of the present invention can be used for the repair of heart valves. Such as mitral valve, tricuspid valve repair.
本领域技术人员均了解瓣膜夹持装置植入时需要递送***辅助植入，递送***包括递送鞘、通液腔、通液腔导管。Those skilled in the art all know that a delivery system is required to assist the implantation of the valve holding device, and the delivery system includes a delivery sheath, a fluid passage, and a fluid passage catheter.
本发明的瓣膜夹持装置使用方法如下：球囊体21、变径阀22和致动丝31在出厂前已经装配完成，锚固件12设有倒刺端连接致动线32。使用时，无需根据患者情况挑选球囊体21的规格，将变径阀22连通通液腔导管，注入和抽吸液体对球囊体21进行排空和折叠，推送致动丝31将固定部1和间隔部2轴向延展使其径向压缩并导入至递送鞘。经下腔静脉路径，从右心房或左心房推出，固定部1和间隔部2被释放，球囊体21被释放，此时处于径向折叠状态，支撑件11变为伸展状态，通过牵引一条或两条致动线32，可相应的单独或同时打开锚固件12，使其捕获瓣叶。沿着致动丝31的轴向移动致动丝31，从而带动固定部1和间隔部2，将支撑架112配置到瓣膜瓣叶下侧，将锚固件12配置在瓣膜瓣叶上侧，利用致动线32使锚固件12锚固原生瓣叶，将球囊体21配置到原生瓣叶之间(如图5所示，图中锚固件12与支撑架112之间的部件为原生瓣叶)。变径阀22初始状态为打开状态，通过通液腔向球囊体21注入合适容积的液体，调整球囊体21的体积，使用影像设备如经食道超声确认反流情况，当球囊体21的体积达到降低反流的最佳效果时，旋转致动丝31，使致动丝31与连接件13脱离，从球囊体21、变径阀22中依次撤出致动丝31。将致动线32切断后撤出。旋转通液腔导管，将变径阀22从初始打开状态调为封堵状态，撤出通液腔导管，完成瓣膜夹持装置的释放。完成瓣膜夹持装置的植入后，可有效减少二尖瓣反流或三尖瓣的反流。The method of using the valve clamping device of the present invention is as follows: the balloon body 21 , the reducing valve 22 and the actuating wire 31 have been assembled before leaving the factory, and the anchor 12 is provided with a barbed end to connect the actuating wire 32 . When in use, it is not necessary to select the specifications of the balloon body 21 according to the patient's condition, connect the reducing valve 22 to the fluid-passage conduit, inject and aspirate the liquid to empty and fold the balloon body 21, and push the actuating wire 31 to fix the fixed part. 1 and the spacer 2 are axially stretched so that they are radially compressed and introduced into the delivery sheath. Through the inferior vena cava route, it is pushed out from the right atrium or left atrium, the fixation part 1 and the spacer part 2 are released, and the balloon body 21 is released. At this time, it is in a radially folded state, and the support 11 becomes an extended state. Or both actuation wires 32, respectively, can open the anchors 12 individually or simultaneously to capture the leaflets. The actuating wire 31 is moved along the axial direction of the actuating wire 31, thereby driving the fixing part 1 and the spacer part 2, the support frame 112 is arranged on the lower side of the valve leaflet, and the anchor 12 is arranged on the upper side of the valve leaflet, using The actuation wire 32 makes the anchor 12 anchor the native valve leaflets, and the balloon body 21 is arranged between the native valve leaflets (as shown in FIG. 5 , the component between the anchor 12 and the support frame 112 in the figure is the native valve leaflet) . The initial state of the reducing valve 22 is the open state, inject a suitable volume of liquid into the balloon body 21 through the liquid passage cavity, adjust the volume of the balloon body 21, and use an imaging device such as transesophageal ultrasound to confirm the reflux situation. When the balloon body 21 When the volume reaches the best effect of reducing regurgitation, the actuating wire 31 is rotated to disengage the actuating wire 31 from the connector 13 , and the actuating wire 31 is withdrawn from the balloon body 21 and the reducing valve 22 in sequence. The actuation wire 32 is cut and withdrawn. Rotate the liquid-passing cavity catheter, adjust the reducing valve 22 from the initial open state to the blocking state, withdraw the liquid-passing cavity catheter, and complete the release of the valve clamping device. After completing the implantation of the valve holding device, it can effectively reduce mitral regurgitation or tricuspid regurgitation.
植入后按医嘱进行随访，如果发现产生新的反流，再次按上述植入方法，用不携带瓣膜夹持装置的递送***进入植入部位，在圈套器或其他工具的辅助下，重新将通液腔导管与变径阀22连接，旋转通液腔导管打开变径阀22，注射或抽吸液体调节球囊体的体积，消除新产生的反流。After implantation, follow up according to the doctor's order. If new regurgitation is found, follow the above implantation method again, enter the implantation site with a delivery system that does not carry a valve holding device, and with the aid of a snare or other tools, re-seal it. The liquid-passing cavity conduit is connected to the reducing valve 22, and the liquid-passing conduit conduit is rotated to open the reducing valve 22, and the volume of the balloon body is adjusted by injecting or aspirating liquid to eliminate newly generated reflux.
在连接件13和密封层111选自生物可降解材料的实施例中，植入后密封层111和连接件13会逐步降解，最终，瓣膜夹持装置仅剩固定在原生瓣叶上的支撑架112、锚固件12和球囊体21(如图6)。如需进行置换手术，可将不携带瓣膜夹持装置的递送***送入植入部位，在圈套器或其他工具的辅助下，连接变径阀22，固定球囊体21，将球囊体21内的液体全部抽吸至体外；使用射频电极导管切割球囊体21与原生瓣叶黏连处直至两者分离(如图7)。撤出间隔部2，再进行人工瓣膜的置换，进一步改善患者的生活质量，延长患者寿命。In the embodiment in which the connecting member 13 and the sealing layer 111 are selected from biodegradable materials, the sealing layer 111 and the connecting member 13 will gradually degrade after implantation, and finally, only the support frame fixed on the original valve leaflet remains in the valve clamping device 112, the anchor 12 and the balloon body 21 (Fig. 6). If replacement surgery is required, a delivery system without a valve holding device can be sent into the implantation site, with the aid of a snare or other tools, the reducing valve 22 is connected, the balloon body 21 is fixed, and the balloon body 21 All the liquid inside is sucked out of the body; use the radio frequency electrode catheter to cut the adhesion between the balloon body 21 and the native valve leaflet until the two are separated (as shown in Figure 7). The septum 2 is withdrawn, and then the artificial valve is replaced, so as to further improve the quality of life of the patient and prolong the life of the patient.
以上的实施例是为了说明本发明公开的实施方案，并不能理解为对本发明的限制。此外，本文所列出的各种修改以及发明中方法的变化，在不脱离本发明的范围和精神的前提下对本 领域内的技术人员来说是显而易见的。虽然已结合本发明的多种具体优选实施例对本发明进行了具体的描述，但应当理解，本发明不应仅限于这些具体实施例。事实上，各种如上所述的对本领域内的技术人员来说显而易见的修改来获取发明都应包括在本发明的范围内。The above examples are intended to illustrate the disclosed embodiments of the present invention, and should not be construed as limiting the present invention. Furthermore, various modifications and variations in the methods of the invention set forth herein will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the present invention has been described in detail in conjunction with various specific preferred embodiments of the present invention, it should be understood that the present invention should not be limited to these specific embodiments. Indeed, various modifications as described above which are obvious to those skilled in the art to obtain the invention are intended to be included within the scope of the present invention.

Claims (11)

  1. 一种瓣膜夹持装置，其特征在于，所述瓣膜夹持装置包括固定部(1)和间隔部(2)，所述固定部(1)包括支撑件(11)、锚固件(12)和连接件(13)，所述间隔部(2)包括球囊体(21)，所述球囊体(21)的近端设有变径阀(22)，所述支撑件(11)、锚固件(12)、球囊体(21)的远端均与连接件(13)连接，所述支撑件(11)与锚固件(12)相对形成瓣膜夹持结构。A valve clamping device, characterized in that the valve clamping device comprises a fixing part (1) and a spacing part (2), and the fixing part (1) comprises a support (11), an anchor (12) and A connecting piece (13), the spacer (2) comprises a balloon body (21), the proximal end of the balloon body (21) is provided with a diameter reducing valve (22), the support piece (11), the anchorage The distal ends of the component (12) and the balloon body (21) are all connected with the connecting component (13), and the supporting component (11) is opposite to the anchor (12) to form a valve clamping structure.
  2. 根据权利要求1所述的瓣膜夹持装置，其特征在于，所述支撑件(11)包括密封层(111)和支撑架(112)，所述密封层(111)设于支撑架(112)表面。The valve clamping device according to claim 1, wherein the support member (11) comprises a sealing layer (111) and a support frame (112), and the sealing layer (111) is provided on the support frame (112) surface.
  3. 根据权利要求2所述的瓣膜夹持装置，其特征在于，所述密封层(111)为密封膜，优选的，所述密封膜的材料为生物可降解材料。The valve clamping device according to claim 2, wherein the sealing layer (111) is a sealing film, and preferably, the material of the sealing film is a biodegradable material.
  4. 根据权利要求2所述的瓣膜夹持装置，其特征在于，所述固定部(1)包括多个支撑架(112)，优选的，所述固定部(1)包括两个支撑架(112)，两个支撑架(112)在连接件(13)两侧对称设置。The valve clamping device according to claim 2, wherein the fixing part (1) comprises a plurality of supporting frames (112), preferably, the fixing part (1) comprises two supporting frames (112) , the two supporting frames (112) are symmetrically arranged on both sides of the connecting piece (13).
  5. 根据权利要求1所述的瓣膜夹持装置，其特征在于，所述锚固件(12)一端与连接件(13)连接，另一端设有倒刺。The valve clamping device according to claim 1, wherein one end of the anchor member (12) is connected with the connecting member (13), and the other end is provided with a barb.
  6. 根据权利要求1所述的瓣膜夹持装置，其特征在于，所述固定部(1)包括多个锚固件(12)优选的，所述固定部(1)包括两个锚固件(12)，两个锚固件(12)在连接件(13)两侧呈对称设置。The valve clamping device according to claim 1, characterized in that, the fixing part (1) comprises a plurality of anchors (12) Preferably, the fixing part (1) comprises two anchors (12), The two anchors (12) are symmetrically arranged on both sides of the connecting piece (13).
  7. 根据权利要求1所述的瓣膜夹持装置，其特征在于，所述连接件(13)的材料选自生物可降解材料。The valve holding device according to claim 1, characterized in that, the material of the connecting member (13) is selected from biodegradable materials.
  8. 根据权利要求1所述的瓣膜夹持装置，其特征在于，所述球囊体(21)与所述固定部(1)位于所述连接件(13)的同一侧，所述球囊体(21)的两侧均设有所述支撑件(11)和所述锚固件(12)，且所述支撑件(11)位于外侧，所述锚固件(12)位于内侧。The valve clamping device according to claim 1, wherein the balloon body (21) and the fixing part (1) are located on the same side of the connecting piece (13), and the balloon body (21) is located on the same side of the connecting member (13). 21) Both sides are provided with the support (11) and the anchor (12), and the support (11) is located on the outside and the anchor (12) is located on the inside.
  9. 根据权利要求1所述的瓣膜夹持装置，其特征在于，所述球囊体(21)的材料选自柔性材料。The valve clamping device according to claim 1, characterized in that, the material of the balloon body (21) is selected from flexible materials.
  10. 根据权利要求1所述的瓣膜夹持装置，其特征在于，所述瓣膜夹持装置还包括致动部(3)，所述致动部(3)包括致动丝(31)和致动线(32)，所述致动丝(31)与连接件(13)和间隔部(2)连接，所述致动线(32)与锚固件(12)的近端连接。The valve clamping device according to claim 1, characterized in that, the valve clamping device further comprises an actuating part (3), and the actuating part (3) comprises an actuating wire (31) and an actuating wire (32), the actuating wire (31) is connected with the connecting piece (13) and the spacer (2), and the actuating wire (32) is connected with the proximal end of the anchor (12).
  11. 根据权利要求1所述的瓣膜夹持装置，其特征在于，所述致动丝(31)穿设于变径阀(22)和球囊体(21)中直至连接件(13)，优选的，所述致动丝(31)为金属丝。The valve clamping device according to claim 1, characterized in that, the actuating wire (31) is passed through the reducing valve (22) and the balloon body (21) up to the connecting piece (13), preferably , the actuating wire (31) is a metal wire.
PCT/CN2021/074688 2020-10-21 2021-02-01 Adjustable and removable valve clamping device WO2022083027A1 (en)

Applications Claiming Priority (4)

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CN202022358481.7U CN214049225U (en) 2020-10-21 2020-10-21 Adjustable removable valve clamping device
CN202011132835.4A CN114376766A (en) 2020-10-21 2020-10-21 Adjustable removable valve clamping device
CN202022358481.7 2020-10-21
CN202011132835.4 2020-10-21

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115153726A (en) * 2022-06-29 2022-10-11 四川大学华西医院 Releaser for releasing metal clip

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100298929A1 (en) * 2005-02-07 2010-11-25 Thornton Troy L Methods, systems and devices for cardiac valve repair
CN106604699A (en) * 2014-09-12 2017-04-26 米特拉尔维尔福科技有限责任公司 Mitral repair and replacement devices and methods
CN109771095A (en) * 2019-01-23 2019-05-21 科凯(南通)生命科学有限公司 A kind of film covering type valve reparation clamp
WO2019209871A1 (en) * 2018-04-24 2019-10-31 Raghuveer Basude Retrievable tissue grasping devices, spacers, artificial valves and related methods
CN110536656A (en) * 2017-04-18 2019-12-03 爱德华兹生命科学公司 Heart valve sealing device and its delivery apparatus
CN111050668A (en) * 2017-07-06 2020-04-21 拉古维尔·巴苏德 Tissue grasping device and related methods
CN111265341A (en) * 2020-03-31 2020-06-12 上海纽脉医疗科技有限公司 Tissue clamping device with locking mechanism
CN111904660A (en) * 2020-03-18 2020-11-10 杭州德晋医疗科技有限公司 Valve clamping device and valve clamping system

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100298929A1 (en) * 2005-02-07 2010-11-25 Thornton Troy L Methods, systems and devices for cardiac valve repair
CN106604699A (en) * 2014-09-12 2017-04-26 米特拉尔维尔福科技有限责任公司 Mitral repair and replacement devices and methods
CN110536656A (en) * 2017-04-18 2019-12-03 爱德华兹生命科学公司 Heart valve sealing device and its delivery apparatus
CN111050668A (en) * 2017-07-06 2020-04-21 拉古维尔·巴苏德 Tissue grasping device and related methods
WO2019209871A1 (en) * 2018-04-24 2019-10-31 Raghuveer Basude Retrievable tissue grasping devices, spacers, artificial valves and related methods
CN109771095A (en) * 2019-01-23 2019-05-21 科凯(南通)生命科学有限公司 A kind of film covering type valve reparation clamp
CN111904660A (en) * 2020-03-18 2020-11-10 杭州德晋医疗科技有限公司 Valve clamping device and valve clamping system
CN111265341A (en) * 2020-03-31 2020-06-12 上海纽脉医疗科技有限公司 Tissue clamping device with locking mechanism

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115153726A (en) * 2022-06-29 2022-10-11 四川大学华西医院 Releaser for releasing metal clip

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