38 results about "Paravalvular leakage" patented technology

The invention discloses a TAVR postoperative blood flow parameter complementing method based on CT-MRI fusion, and belongs to the technical field of crossing of medical image processing and computational fluid mechanics. A CT valve frame registration technology is adopted, an invisible artificial valve leaflet three-dimensional structure is reconstructed through valve frame information in a CT image and is coupled with a dynamic heart model, a complete valve mechanical and functional simulation platform is constructed, the problem of an imaging blind area is solved, hemodynamic parameters of an inlet and an outlet of a postoperative area are further collected in combination with 4D Flow MRI, and the artificial valve leaflet three-dimensional structure is obtained. The blood flow conditions of the upstream and the downstream of the artificial valve area at each stage of contraction and relaxation of the TAVR postoperative part are comprehensively restored, the temporal-spatial resolution and the physical authenticity of the boundary condition in fluid-solid coupling simulation are greatly improved, and the more real passive response of the valve leaflet under the action of the blood flow is obtained; and a reliable basis is provided for quantitative and mechanical risk analysis of postoperative complications such as thrombosis, perivalvular leakage and valve leaflet fatigue.

The application provides a kind of replacement valve device and its support by catheterization, it is related to heart valve technical field.The replacement valve support by catheterization includes support main body, anchoring structure, skirt support structure and sealing membrane.The sealing membrane is circumferentially closed cylindrical structure, sealing membrane includes the first sealing section and the second sealing section being arranged along the axial direction and being connected with each other, the first sealing section is tightly arranged on part or all of skirt support structure, the second sealing section is tightly arranged on part or all of support main body;Sealing membrane is arranged on the inner side and / or outer side of skirt support structure and support main body.The application can solve the problem that sealing membrane and valve support do not fit in the prior art, poor sealing, leading to sealing membrane in blood, leading to paravalvular leakage or causing other complications, with high degree of fit, good sealing, can avoid sealing membrane in blood, effectively avoid paravalvular leakage or cause other complications.

The application relates to the technical field of medical devices, in particular to a valve support for mitral valve replacement, which comprises an annular support formed integrally, one end of the support is provided with an anchoring part, and the other end is provided with a connecting part; the connecting part comprises a connecting arm, the connecting arm comprises a bending section and a connecting section which are connected to each other, the bending section is integrally extended from the support, and the connecting section is provided with a flexible section used for abutting against the atrial wall; the anchoring part comprises a bendable anchoring arm, one end of the anchoring arm away from the support is provided with a clamping part used for anchoring the valve, and a fixing part used for preventing the valve from rotating. The valve support has the beneficial effects that the anchoring performance of the valve support is enhanced, and the risk of paravalvular leakage is reduced.

A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

This invention discloses a valve prosthesis, including an inflow end and an outflow end. The valve prosthesis includes a support, a seal, and a cover. The cover at least covers the portion of the support near the inflow end. The seal includes a sealing material, a first fixing member, and a second fixing member. The sealing material includes a first side and a second side disposed opposite to each other. The first side or its vicinity is fixed to the cover with the first fixing member. Then, the second side is rolled or folded to approach the first side, forming an annular structure disposed on the outside of the cover. The second fixing member then fixes the annular structure to the cover. This invention provides a seal that is precisely positioned and shaped on the valve prosthesis support, thereby better adapting to the physiological environment in the body and greatly reducing the occurrence of paravalvular leakage.

The invention relates to the technical field of medical instruments, in particular to a forward torque self-locking mitral valve replacement valve stent which comprises an annular atrial umbrella disc and a plurality of flexible supporting parts which are sequentially connected in the circumferential direction to form the atrial umbrella disc. Due to the arrangement of the inner concave sections, the grid units form outer edge parts which are bent in the circumferential direction, and the bending direction of the outer edge parts is the instantaneous needle direction; the annular support anchoring disc is formed by sequentially connecting a plurality of anchoring arms in the circumferential direction, the circumferential bending direction of the anchoring arms is the same as the circumferential bending direction of the outer edge part, and the anchoring arms are matched with the grid units. The valve support has the advantages that the forward torque self-locking effect can be generated, the valve support continuously winds and hooks the chordae tendineae, the attaching force of the valve support and an original valve leaflet is kept, the valve is prevented from shifting and slipping, and the perivalvular leakage risk is reduced.

A transcatheter heart valve includes a paravalvular seal that is configured for transfemoral delivery. The valve includes a frame and the seal is formed from a plurality of outwardly extending fibers.

This invention discloses a novel valve stent and artificial heart valve, belonging to the field of medical device technology. The valve stent has a hollow, symmetrical, mesh-like tubular structure, with a first layer of hexagonal mesh groups, a second layer of polygonal mesh groups, and a third layer of polygonal mesh groups arranged sequentially from the outflow end to the inflow end. The stent has a small overall mesh count and symmetrical structure, resulting in uniform deformation during compression and expansion. It exhibits excellent radial support and minimal expansion rebound, significantly reducing the risk of paravalvular leakage. While maintaining radial support, this invention can reduce the stent strut width to 0.2–0.4 mm, and the minimum outer diameter of the valve after compression can reach 2.5–4.5 mm. Simultaneously, the overall length change during stent compression and expansion is minimal, greatly improving the smoothness of vascular delivery and the accuracy of valve implantation positioning. This meets the clinical needs of transcatheter aortic valve replacement surgery, enhancing the safety and effectiveness of artificial heart valve implantation.

The utility model relates to the technical field of medical instruments, in particular to an artificial valve clamping piece and a conveying system. The artificial valve clamping piece comprises a clamping piece body, a connecting wire and a traction structure, the clamping piece body comprises a pipe body and a plurality of through holes formed in the pipe body, the pipe body is in a wave shape, and the two ends of the pipe body are closed to form a ring shape; the connecting wire penetrates into the tube body, and the end part of the connecting wire penetrates through the through hole in the tube body and then is suitable for being connected with the artificial valve; the traction structure comprises a traction wire, the traction wire is arranged in the pipe body in a penetrating mode through a through hole in the pipe body, and the traction wire is suitable for being connected with a conveying system. The clamping piece is of a periodic wave-shaped or fluctuating annular structure, can be fixed to the periphery of the outer surface of the artificial valve, can be radially compressed and expanded according to the size of the internal artificial valve, and is matched with the artificial valve to clamp the autologous valve leaflet, so that the artificial valve can be stably anchored at an accurate position without displacement, and meanwhile, the clamping piece can be used for clamping the autologous valve leaflet. The clamping device can reduce the occurrence risk of perivalvular leakage.

The present application relates to a kind of artificial heart valve stents and artificial heart valve.The artificial heart valve stent includes inner support and outer support.Inclination from inflow end to outflow end, first portion and second portion are included in sequence in inner support, the radial dimension of first portion is greater than the radial dimension of second portion, at least a portion of second portion is nested in outer support, and at least a portion of first portion extends to inflow end relative to outer support, and the portion of first portion extending to inflow end relative to outer support covers flow blocking film.The artificial heart valve includes the artificial heart valve stent and artificial valve leaflet fixedly connected in inner support.The artificial heart valve stent and artificial heart valve can reduce the risk of paravalvular leakage while being stably positioned in heart.

Provided are an artificial intelligence AI-based simulation device and method for supporting procedure planning in transcatheter aortic valve implantation. The device receives patient-specific medical images, such as computed tomography data, and generates a three-dimensional (3D) model of the aortic root and native valve. An artificial valve is virtually inserted into the 3D model, and the virtual implantation model is automatically converted into mesh data suitable for Computational Fluid Dynamics (CFD) and Fluid-Structure Interaction (FSI) analysis. The processor performs CFD / FSI simulations to evaluate hemodynamic changes, structural stresses, and potential device-tissue interactions. Based on the analysis, the system outputs predicted risks of procedure-related complications (including coronary obstruction, annular rupture, paravalvular leakage, and valve deformation) and provides guideline data for selecting valve size, implantation depth, and insertion angle. The disclosed device and method enable accurate, patient-specific prediction and visualization, thereby assisting clinicians in establishing safe and optimized TAVI procedure plans.

A transcatheter heart valve includes a paravalvular seal that is configured for transfemoral delivery. The valve includes a frame and the seal is formed from a plurality of outwardly extending fibers.

Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, the prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved inner catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.

This invention provides a transcatheter valve prosthesis comprising a stent, a prosthetic valve component, and a paravalvular leakage prevention component. The paravalvular leakage prevention component is coupled to the stent and includes an inner skirt, an outer covering, a lumen, an opening, and a one-way valve. The inner skirt is disposed on an inner surface of the stent and has an inflow end and a downstream end. The outer covering surrounds an outer surface of the stent and has an inflow end and a downstream end, the inflow end being coupled to the inflow end of the inner skirt. The lumen is formed between the outer surface of the inner skirt and the inner surface of the outer covering. The opening is disposed between the inner skirt and the outer covering. The one-way valve includes a flap at the opening, the flap being configured to open to allow blood to flow into the lumen but prevent blood from flowing out of the lumen.

A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments.

This invention relates to a valve prosthesis, which includes a support body and an elastic element disposed outside the support body. The support body has a through-hole, and the elastic element is arranged circumferentially around the support body, forming an annular cavity structure with the support body. The through-hole communicates with the annular cavity structure. Thus, by providing a through-hole in the support body, the through-hole communicates with the semi-closed structure, allowing blood flow within the semi-closed structure to flow out through the through-hole, preventing blood from stagnating within the semi-closed structure and forming a thrombus, thus promoting smooth blood flow. Furthermore, blood flow in the opposite direction can flow into the elastic element, where it is buffered, preventing blood from directly overflowing from the sidewall of the stent due to the through-hole in the inner fabric, thus avoiding paravalvular leakage.

The application discloses a heart valve stent and a prosthesis thereof, and the heart valve stent comprises a stent body, the stent body has an inflow tract and an outflow tract which are axially connected, the inflow tract and the outflow tract are both composed of mesh structure units which are connected with each other, the stent body is provided with a grab ear structure which extends towards the proximal end of the inflow tract, the proximal end of the inflow tract is outwardly folded, and a gap is formed between the proximal end of the grab ear structure and the inflow tract. The heart valve prosthesis provided by the application has the advantages that the diameter of the valve leaflet is small, the fatigue resistance of the valve is good, the outflow tract obstruction and the paravalvular leakage can be avoided or reduced, the diameter of the catheter of the conveying system adapted to the application is small, the conveying difficulty and the risk of blood vessel injury are reduced, and the phenomenon of systolic anterior motion (SAM) can be reduced, so that the risk of left ventricular outflow tract obstruction is reduced.

A transcatheter heart valve includes a paravalvular seal that is configured for transfemoral delivery. The valve includes a frame and the seal is formed from a plurality of outwardly extending fibers.

Provided is a valve prosthesis (200), comprising an inflow end (242) and an outflow end (241). The valve prosthesis (200) comprises a stent (210), a sealing member (220), and a covering membrane (260). The covering membrane (260) covers at least a portion of the stent close to the inflow end. The sealing member (220) comprises a sealing material (2201), a first fixing member (2202), and a second fixing member (2203). The sealing material (2201) comprises a first edge (2201a) and a second edge (2201b) that are arranged opposite. The first edge (2201a) or a region near the first edge is fixed to the covering membrane (260) by the first fixing member (2202), then the second edge (2201b) is rolled or folded to approach the first edge (2201a) to form an annular structure (2201c) arranged on the outer side of the covering membrane (260), and then the annular structure (2201c) is fixed to the covering membrane (260) by the second fixing member (2203). Therefore, a sealing member that is accurately positioned on the valve prosthesis stent and shaped can be obtained, with reduced potential of paravalvular leakage.

This application belongs to the field of medical devices, specifically relating to a valve prosthesis and its delivery system for preventing paravalvular leakage. It includes a leak-proof device and a stent. The stent includes a valve suture segment. The leak-proof device is connected to the proximal portion of the stent. The leak-proof device has an irregular structure and has a first form and a second form. When the leak-proof device is in the first form, it is offset from the valve suture segment in the axial direction. When the leak-proof device changes from the first form to the second form, it returns to the preset form along a preset path towards the distal end of the stent, and at least a portion of the leak-proof device overlaps with the valve suture segment in the axial direction. This invention achieves a significant reduction in tube diameter and can specifically adapt to the physiological structure of the autologous valve, allowing it to better fit the autologous valve annulus and atrial tissue, effectively preventing regurgitation.

The application relates to a paravalvular leakage plugging device applied to a prosthetic valve with an annular body, comprising biodegradable foam attached to at least a section of the outer periphery of the annular body, which is water-swellable and has a first degradation rate; and a film wrapping the biodegradable foam, which is configured as a porous film and has a second degradation rate; when the biodegradable foam swells upon contact with water, the film does not constrain the swelling of the biodegradable foam, and the first degradation rate is different from the second degradation rate. The paravalvular leakage plugging device adopts biodegradable foam to plug the leakage, compared with a traditional metal plugging device, does not cause damage to the heart tissue and the valve, reduces the risk of complications, and meanwhile, the biodegradable foam gradually degrades after completing plugging, so that no residues are left in the human body, further reducing the long-term risk.

The invention discloses a balloon dilatation valve with a clamping piece, and relates to the technical field of medical instruments, the balloon dilatation valve comprises a valve support capable of expanding in the radial direction, a functional valve arranged on the inner side of the valve support and the clamping piece connected to the valve support; the clamping piece can move relative to the valve support and is matched with the valve support to clamp the autologous valve leaflet, the clamping piece comprises a plurality of rebounding components with deformation parts, and the rebounding components are converted between bunchy lines and fan-shaped distribution through deformation of the deformation parts. The valve stent further comprises a control sleeve which is used for restraining the clamping piece in the conveying state and adjusting and controlling the included angle between the clamping piece and the valve stent by changing the restraining degree. The mitral valve anterior leaflet is clamped and shortened through the clamping piece, and left ventricular outflow tract obstruction is effectively prevented; meanwhile, stable clamping force is formed by the clamping piece and the valve support, and displacement of the valve is prevented; in addition, the delivery system is small in outer diameter, good in trafficability and suitable for patients with small mitral valve openings and small heart cavities.

Embodiments herein include a cardiac stent-valve for transcatheter delivery being compressible to a compressed state for delivery, and expandable to an expanded state for implantation. The stent-valve including a stent with an axial inflow end and an axial outflow end, a plurality of leaflets arranged within the stent, and a sealing skirt for reduction or prevention of paravalvular leakage. In the expanded state, the sealing skirt includes a tubular inner wall and at least one pocket which is positioned on the tubular inner wall and comprises an outer wall which extends radially outward from the tubular inner wall. The pocket is configured to be distended radially outward in response to inflow of blood in the expanded state. In the expanded state, the outer wall of the pocket includes one or more pre-shaped bulges which extend radially outward from the outer wall of the pocket. Other embodiments are also included herein.

The application is a divisional application, and the application number of the original application is 2022105409207. The invention relates to an artificial heart valve which comprises a valve support, a first sealing film, a second sealing film and a valve leaf.The first sealing film is attached to the outer side of the valve support, can make contact with blood, gradually absorbs liquid and expands along with prolonging of the implantation time of the valve support and is used for reducing perivalvular leakage; the second sealing film is arranged on the outer side of the first sealing film, and after the first sealing film absorbs liquid and expands, the second sealing film can also expand to a certain degree and is used for increasing the friction force between the second sealing film and the native valve leaflet; the valve leaflet is arranged in the valve support and used for controlling one-way flow of blood. The first sealing film and the second sealing film are arranged, so that the artificial heart valve can be better matched with a native tissue after being implanted, and perivalvular leakage is effectively prevented.

The utility model provides an artificial valve anchoring device which comprises two clamping arms connected with each other and a carrying arm connected between the two clamping arms, and any clamping arm comprises a clamping part, an opening and closing part and a transition part which are connected with each other. The clamping parts on the two clamping arms are arranged in a crossed manner, so that a clamping space with an opening is formed between the two clamping parts; after the artificial valve anchoring device reaches a designated position and is released, in the valve expansion process, the intersection position of the clamping parts on the two clamping arms is changed so that the clamping space between the clamping parts can be reduced, and the native valve leaflet in the clamping space can be clamped. Under the condition that a valve smaller than a valve ring is selected, anchoring can still be well achieved, displacement of the valve is avoided, and the risk of perivalvular leakage can be effectively reduced by clamping reflux holes of adjacent valve leaflets through the artificial valve anchoring device.

A prosthetic mitral valve includes a stent frame and an anchor assembly coupled to and peripherally surrounding the stent frame. The anchor assembly includes atrial anchors on the inflow end, ventricular anchors on the outflow end, and a central waist portion disposed therebetween. The anchor assembly generally defines an hourglass shape wherein the atrial and ventricular anchors flare radially outward and the central waist portion has a relatively smaller diameter. The prosthetic valve may include a gasket disposed peripherally around the central waist portion to seal the space between the body of the valve and the native valve annulus to prevent paravalvular leakage without increasing the profile of the valve to allow for smooth insertion into and deployment from a delivery device. The prosthetic valve may alternatively include a sealing fabric surrounding the anchor assembly defining a radial protrusion around the central waist portion to seal the native annulus.

The present invention provides a prosthetic heart valve device with improved fit, apposition and / or paravalvular leakage mitigation. Thus, the prosthetic device comprises an anchoring structure for supporting prosthetic valve leaflets, wherein the anchoring structure comprises and / or is formed at least partially from a hydrophilic material designed to swell when contacted by the water solute in the patient's blood. Locating the hydrophilic material to provide swelling to improve the fit and / or apposition of the device to the patient's tissues results in, inter alia, improved paravalvular leakage mitigation. Some of the methods and mechanisms described herein may also be used to provide a seal against the septal hole created during transseptal delivery of the device.

The application relates to the technical field of medical devices, and provides a valve stent and a valve prosthesis, wherein the valve stent comprises a support main body for connecting artificial valve leaves and at least one abutting support group connected with the support main body, the abutting support group comprises a first abutting support and a second abutting support for abutting the same native valve leaf, and the first abutting support comprises an extension section located at the radial outer side of the support main body, having a gap in the radial direction with the support main body and having an overlapping area in the axial direction. Through the technical scheme, the elastic force of the valve stent can be improved, the valve stent is more easily attached to the native valve ring, and the problem of paravalvular leakage is reduced.

Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, the prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved inner catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.

This invention discloses a sealing skirt for a heart valve, a heart valve, and a method for its preparation. The sealing skirt is disposed circumferentially on the outside of the valve arch. The sealing skirt includes a sealing skirt body and at least one sealing portion surrounding the outside of the sealing skirt body. One edge of the sealing portion is sealed to the sealing skirt body circumferentially, and the other edge of the sealing portion is connected to the sealing skirt body at multiple spaced intervals along the circumferential direction of the sealing skirt. The resulting sealing portion has multiple pocket-shaped structures with openings facing the same side and arranged sequentially in the circumferential direction of the sealing skirt. These pocket-shaped structures can be expanded away from the valve arch by the action of regurgitated blood. In the event of regurgitation, the pocket-shaped structures can be expanded by the pressure of the regurgitated blood, resulting in a better sealing fit between the expanded pocket-shaped structures and the valve annulus, effectively solving the problem of paravalvular leakage.