WO2022083027A1 - Dispositif d'agrafage de valve réglable et amovible - Google Patents

Dispositif d'agrafage de valve réglable et amovible 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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English (en)
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.)
Filing date
Publication date
Priority claimed from CN202022358481.7U external-priority patent/CN214049225U/zh
Priority claimed from CN202011132835.4A external-priority patent/CN114376766A/zh
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/fr

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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.

Abstract

Un dispositif d'agrafage de valve réglable et amovible, comprenant une partie de fixation (1) et une partie d'espacement (2). La partie de fixation (1) comprend un élément de support (11), un élément d'ancrage (12), et un élément de liaison (13) ; la partie d'espacement (2) comprend un corps de ballonnet (21) et une valve de diamètre variable (22) qui sont reliés ; et l'élément de support (11), l'élément d'ancrage (12) et le corps de ballonnet (21) sont tous reliés à l'élément de liaison (13). Le dispositif d'agrafage de valve peut s'adapter à des structures anatomiques de diverses dimensions non linéaires, de façon à étendre la plage d'indications ; après modification de la dimension anatomique autour de la valve mitrale à l'issue d'une opération, une interface de ré-intervention est fournie, et la distance d'agrafage et la tension sont ajustées, de façon à soulager la régurgitation provoquée par la reconstruction ventriculaire gauche après l'opération, et à prolonger davantage l'effet de traitement ; les parties fournissent des structures d'agrafage fiables au début de l'implantation, la régurgitation est réduite, certaines des structures peuvent être dégradées après une période de temps après l'opération, et un espace est fourni pour un moyen de remplacement et autre traitement éventuellement nécessaire par un pronostic à long terme.
PCT/CN2021/074688 2020-10-21 2021-02-01 Dispositif d'agrafage de valve réglable et amovible WO2022083027A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202022358481.7U CN214049225U (zh) 2020-10-21 2020-10-21 一种可调节可移除的瓣膜夹持装置
CN202022358481.7 2020-10-21
CN202011132835.4 2020-10-21
CN202011132835.4A CN114376766A (zh) 2020-10-21 2020-10-21 一种可调节可移除的瓣膜夹持装置

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115153726A (zh) * 2022-06-29 2022-10-11 四川大学华西医院 一种用于释放金属夹的释放器

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US20100298929A1 (en) * 2005-02-07 2010-11-25 Thornton Troy L Methods, systems and devices for cardiac valve repair
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WO2019209871A1 (fr) * 2018-04-24 2019-10-31 Raghuveer Basude Dispositifs de préhension de tissu récupérables, éléments d'espacement, valvules artificielles et procédés associés
CN110536656A (zh) * 2017-04-18 2019-12-03 爱德华兹生命科学公司 心脏瓣膜密封装置及其递送装置
CN111050668A (zh) * 2017-07-06 2020-04-21 拉古维尔·巴苏德 组织抓取装置及相关方法
CN111265341A (zh) * 2020-03-31 2020-06-12 上海纽脉医疗科技有限公司 一种具有锁止机构的组织夹持装置
CN111904660A (zh) * 2020-03-18 2020-11-10 杭州德晋医疗科技有限公司 瓣膜夹合装置及瓣膜夹合系统

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* 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 (zh) * 2014-09-12 2017-04-26 米特拉尔维尔福科技有限责任公司 二尖瓣修复和替换设备及方法
CN110536656A (zh) * 2017-04-18 2019-12-03 爱德华兹生命科学公司 心脏瓣膜密封装置及其递送装置
CN111050668A (zh) * 2017-07-06 2020-04-21 拉古维尔·巴苏德 组织抓取装置及相关方法
WO2019209871A1 (fr) * 2018-04-24 2019-10-31 Raghuveer Basude Dispositifs de préhension de tissu récupérables, éléments d'espacement, valvules artificielles et procédés associés
CN109771095A (zh) * 2019-01-23 2019-05-21 科凯(南通)生命科学有限公司 一种覆膜式瓣膜修复夹体
CN111904660A (zh) * 2020-03-18 2020-11-10 杭州德晋医疗科技有限公司 瓣膜夹合装置及瓣膜夹合系统
CN111265341A (zh) * 2020-03-31 2020-06-12 上海纽脉医疗科技有限公司 一种具有锁止机构的组织夹持装置

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115153726A (zh) * 2022-06-29 2022-10-11 四川大学华西医院 一种用于释放金属夹的释放器

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