WO2018214826A1 - 一种改进密封效果的左心耳封堵器及其制备方法 - Google Patents
一种改进密封效果的左心耳封堵器及其制备方法 Download PDFInfo
- Publication number
- WO2018214826A1 WO2018214826A1 PCT/CN2018/087552 CN2018087552W WO2018214826A1 WO 2018214826 A1 WO2018214826 A1 WO 2018214826A1 CN 2018087552 W CN2018087552 W CN 2018087552W WO 2018214826 A1 WO2018214826 A1 WO 2018214826A1
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- WIPO (PCT)
- Prior art keywords
- sealing
- left atrial
- atrial appendage
- appendage occluder
- anchor
- Prior art date
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- 0 CC(C)(*)CS=CCCCC1CCCCC1 Chemical compound CC(C)(*)CS=CCCCC1CCCCC1 0.000 description 2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00597—Implements comprising a membrane
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00632—Occluding a cavity, i.e. closing a blind opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00955—Material properties thermoplastic
Definitions
- the invention relates to a medical device, in particular to an interventional treatment device for sealing a left atrial appendage and a preparation method thereof.
- Atrial fibrillation is the most common persistent arrhythmia. With the increasing incidence of atrial fibrillation, the number of people over the age of 75 can reach 10%. The frequency of atrial excitement during atrial fibrillation is 300-600 beats/min. The heart rate is often fast and irregular, and the atrium loses its effective contractile function. The left atrial appendage contraction force decreases during atrial fibrillation, and the morphological characteristics of the left atrial appendage and the trabecular convexity and concaveness in the left atrial appendage cause the blood flow in the left atrial appendage to vortex and slow down the flow rate, which promotes thrombosis.
- More than 90% of left atrial thrombus in patients with non-valvular atrial fibrillation is present in the left atrial appendage. After the thrombus falls off, it will enter the brain arteries through the aorta to form a cerebral embolism or stroke.
- Anticoagulant therapy refers to the inhibition of blood coagulation by taking anticoagulant drugs to reduce the risk of thrombosis in the left atrial appendage, thereby reducing the incidence of stroke.
- Clinical trials have shown that anticoagulant therapy can significantly reduce the incidence of stroke, but anticoagulant therapy is a long process, and there are also obvious complications, mainly as bleeding complications, and may be more serious.
- Surgical treatment includes surgical resection or suturing the left atrial appendage, but the surgical trauma is large, usually completed during other operations such as valve replacement or coronary artery bypass grafting.
- Percutaneous left atrial appendage occlusion treatment refers to the delivery of a left atrial appendage occluder to the left atrial appendage located in the right atrium of the heart by percutaneous puncture using a small diameter delivery sheath.
- the left atrial appendage occluder can block the opening position of the left atrial appendage, and the blood flow in the atrium cannot enter the left atrial appendage, so the thrombus cannot be formed, thereby achieving the purpose of preventing thromboembolism of atrial fibrillation.
- percutaneous left atrial appendage treatment has been put into use, and animal experiments and clinical trials have been carried out. Clinical trials have shown that left atrial appendage occlusion can effectively reduce the incidence of stroke in patients with atrial fibrillation.
- the residual shunt of the instrument is one of the main complications of the left atrial appendage occlusion.
- the left atrial appendage occluder of the double disc structure is usually composed of a sealing portion and an anchoring portion. After the release, the sealing portion blocks the opening position of the left atrial appendage, and the anchoring portion is released inside the left atrial appendage and has a barb. The role of the fixed seal. After release, the sealing portion of the left atrial appendage occluder should be closely attached to the left atrial appendage opening position to block the left atrial appendage. If the sealing portion cannot be closely fitted to the left atrial appendage, the sealing portion may be suspended in the left atrium, and the left atrial appendage may not be effectively blocked, and the risk of thrombosis may be further increased.
- a major factor that causes the seal to be ineffectively attached to the left atrial appendage is related to the connection between the seal and the anchor, ie, the anchor and the seal cannot be tightly connected together, product
- the overall length is long, and the anchor portion is radially compressed after release, further increasing the overall length of the product after release, and at the same time, the axial distance between the sealing portion and the anchor portion is increased, and the sealing portion cannot be effectively attached after being released.
- the left atrial appendage causing residual shunt.
- the invention provides a left atrial appendage occluder, which improves the connection manner between the sealing portion and the anchoring portion, can avoid and delay the axial lengthening of the left atrial appendage occluder as a whole, and further ensures that the sealing portion is attached and sealed to the left atrial appendage. mouth.
- a left atrial appendage occluder for improving the sealing effect includes an interconnecting seal portion and an anchor portion, the seal portion and the anchor portion abutting each other.
- the mutual abutment of the sealing portion and the anchoring portion can be understood as that at least a portion of the sealing portion and the anchoring portion are in contact with each other, and the sealing portion is deformed due to the abutting force.
- the tight connection between the sealing portion and the anchoring portion can be realized by applying a pre-tightening force, and the occlusion device can better attach and seal the left atrial appendage after being released, even if the anchoring portion or the sealing portion is radially By compressing and lengthening, the sealing portion and the anchoring portion can be kept in contact with each other to ensure the sealing effect.
- the left atrial appendage occluder of the invention can effectively improve the sealing performance and reduce the residual shunt.
- one or more baffles are disposed in the sealing portion; a coating may be applied to the periphery of the anchoring portion, such as a full or partial coating on the outer surface of the anchoring disk.
- the shape and positional relationship described in the present invention are the state in which the left atrial appendage occluder is released and expanded in the body, and may also be referred to as a released state or an expanded state, and the left atrial appendage occluder is released before release. Compressed in the delivery device, it can be referred to as a compressed state or a pre-release state.
- sealing portion and the anchoring portion are each independently a wire frame structure or a mesh structure.
- the sealing portion and the anchoring portion can be respectively processed by knitting or cutting, and the sealing portion (anchoring portion) can adopt a regular or irregular wire frame structure, and when the wire frame structure is adopted, the skeleton can be set at an appropriate position as needed.
- the skeleton may be an increase in the cross-sectional area relative to other portions, or at least have a higher strength
- the network structure may be a regular or irregular cell, preferably a diamond-shaped or approximately diamond-shaped cell, at least Compressed in the radial direction for recovery and release
- the mesh structure has a distinct warp and weft structure, and the warp and weft intersections may be fixed nodes, more preferably in a non-fixed manner, that is, misalignment between the warp and weft may be provided to provide compliance and Deformation ability.
- the sealing portion is a sealing disk or a sealing plug.
- disc and plug are understood to have a general shape characteristic, for example, the disc is flat, and its outer edge shape substantially conforms to the physiological structural features at the left atrial appendage, such as a circular shape or other shapes according to actual needs.
- the plug is a columnar shape having a certain thickness, for example, a cylinder, a circular table or the like, but the shape of the outer circumference or the bus bar is not strictly limited.
- the prior art can be referred to, and on the other hand, the sealing portion itself can be used according to actual needs.
- the shape of the invention is not an improvement of the present invention, and of course, the present invention provides a preferred or improved solution.
- the sealing portion is a sealing disk and has a predetermined state in which it is not in contact with the anchor portion and an abutting state in contact with the anchor portion; and a bottom portion of the sealing disk in the abutting state with respect to the predetermined state
- the middle portion has a deformation toward the anchor portion in the axial direction.
- the middle portion of the bottom of the sealing disk of the abutting state has a deformation axially convex toward the anchor portion with respect to the predetermined type.
- the sealing portion comprises a disk surface facing away from the anchoring portion, a disc bottom facing the anchoring portion, and a waist portion connecting the disc surface and the disc bottom, wherein the disc bottom is a flat bottom or the middle portion of the disc bottom is convex toward the anchor portion. Up or the middle of the bottom of the disc protrudes toward the side of the anchoring portion.
- the disc surface, the bottom of the disc and the waist form a cage structure as a whole, and one or more choke membranes may be disposed inside the cage structure, and the cage structure may be closed or partially open in addition to the necessary hollow portion, in the knitting process In the case of the sealing portion, there may be a converging end at the bottom of the disc and the surface of the disc.
- the cage structure has a certain space inside, the sealing effect can be ensured even if there is a certain deformation, and is particularly suitable for the feature that the anchor portion is abutted in the present invention.
- the diameter of the cage structure is mainly such that the diameter of the waist is substantially equal to the diameter of the anchor portion, and the diameter of the disk surface is slightly larger than the diameter of the waist portion to improve the sealing effect of the end portion.
- the sealing portion has a predetermined type state that is not in contact with the anchor portion and an abutting state in contact with the anchor portion, and the diameter of the disc bottom in the predetermined type state is larger than the bottom of the disc in the abutting state. diameter of.
- the diameter of the disk surface or the bottom of the disk described herein may be approximately circular. If it is other shapes, it can be understood as the relative relationship of the sectional area or the overall thickness. For example, the circular shape is larger than the bottom of the disk.
- the diameter of the whole is therefore a truncated cone shape, and the top surface of the upper portion is slightly larger, and the more the lower portion converges, the lower surface of the lower portion is slightly smaller, so that it conforms to the anchor portion when it abuts against the anchor portion.
- the sealing portion has a predetermined state that is not in contact with the anchor portion and an abutting state in contact with the anchor portion, and the sealing portion in the abutting state is at the waist and/or the bottom of the disk with respect to the predetermined state. Has a deformation.
- the predetermined state refers to a shape obtained by heat setting after the sealing portion itself is processed without being assembled or subjected to an external force, and is abutted against the anchoring portion after assembly, and in order to increase or maintain the pre-tightening force, The anchoring portion is deformed to be deformed.
- the sealing portion in the abutting state has a radially collapsed deformation at the waist with respect to the predetermined state.
- the deformation of the radial gather can offset or delay the tendency of the axial extension to ensure the sealing of the opening portion of the left atrial appendage.
- the deformation of the radial gather can make the waist produce a certain taper, and it is better to fit the left atrial appendage to improve the sealing effect.
- the sealing portion in the abutting state has a deformation in the disk bottom convex toward the anchor portion with respect to the predetermined state.
- the deformation of the axial projection toward the anchor portion can also counteract or delay the axial extension of the left atrial appendage occluder as a whole. Keep the sealing part and the anchoring part as close as possible to ensure the sealing effect.
- the sealing portion abuts the anchor portion at least at an outer edge portion of the bottom of the disk.
- the outer edge of the bottom of the disc is in contact with the anchoring portion to obtain a larger deformation of the seal portion under the same pre-tightening force, which is more advantageous for compensating and counteracting the axial extension.
- sealing portion and the anchor portion are staggered by respective connection ends.
- sealing portion and the anchor portion are each converged and connected by a connecting member.
- the constriction of the seal portion and the anchor portion can be regarded as a connection portion formed by the shape convergence, and the connection portion between the seal portion and the anchor portion is extended and displaced in a staggered manner.
- the connecting portion formed by the shape convergence is not limited to adopting a method of converging.
- the connecting portions of the sealing portion and the anchoring portion are generally aligned with each other, and if the direct connection is made, the end faces directly meet each other, of course, With a transitional connection, this configuration can result in an occluder that is too long in axial length overall, which is detrimental to sealing.
- the connecting portion of the sealing portion and the anchoring portion is arranged in a dislocation manner, which can avoid spatial interference in the process of approaching each other, greatly reduce the spacing between the sealing portion and the anchoring portion, and improve the sealing effect.
- sealing portion and the anchoring portion are integrally formed with the respective connecting portions, or are separated from each other.
- sealing portion and the anchor portion and the respective connecting portions may be integrally formed after cutting or knitting, or the connecting portion may be assembled as an independent member by means of welding or the like.
- the preferred form is a one-piece construction that facilitates processing as well as overall strength.
- the shape converges to global convergence or local convergence.
- the sealing portion and the anchoring portion have a certain diameter range because the left atrial appendage is to be blocked, and the diameter of the connecting portion is relatively thin, and the diameter change therebetween may be a gradual change or a sudden change, for example, the position of the diameter change is presented as a cone by the overall convergence method. Shape structure, and local convergence can be seen as a sudden change in diameter, such as a larger cross-sectional area mutated into a thinner rod or bundle.
- the connecting portions on the sealing portion and the anchoring portion are all in one place and connected to each other; or the connecting portion on the sealing portion and the anchoring portion are in multiple places, and one-to-one correspondence Interconnected.
- the number and position of the joints are not strictly limited. When only one place is used, it is generally in the middle of the seal or anchor.
- connecting portions of the sealing portion and the anchoring portion are directly connected or connected by a connecting member.
- the connector can be a single component or a component of multiple components.
- the connecting portion of the sealing portion and the anchor portion all extend in a straight line;
- One of the connections extends in a straight line and the other extends along the curve;
- the sealing portion and the anchoring portion are arranged opposite to each other, and the connecting portions of the two are connected to each other and are connected to each other, and the path is not strictly limited during the extending process.
- the preferred embodiment is the sealing portion and the anchoring portion.
- the connecting portions all extend in a straight line.
- the shape of the joint itself may be either a simple straight rod or a relatively complicated three-dimensional structure, so the straight line extension here should be understood as an overall trend, that is, the extension process does not have an overall meandering or bending.
- connection portions of both the sealing portion and the anchor portion extend in the axial direction of the left atrial appendage occluder.
- the connecting portions of the sealing portion and the anchoring portion are nested or offset from each other at the mutually mating portions.
- connection between the sealing portion and the anchoring portion may be abutting or having a certain gap.
- the connecting portions of the sealing portion and the anchor portion extend toward each other and pass over the end of the other end.
- one of the connecting portions passes over the end of the other end, it also means that the end of the other connecting portion passes over the distal end of the connecting portion, so that the connecting portions of the two portions are at the mutual fitting portion along the axis of the vertical left atrial appendage occluder
- the projections are arranged side by side or at least partially overlapping.
- the projections thereof When the connecting portions of the sealing portion and the anchoring portion are nested with each other, the projections thereof must also overlap. When they are deviated from each other, the projected shape is related to the angle of view, so that side by side or partial overlap is possible, if the sealing portion and the anchoring portion are possible. Despite the misalignment, but did not continue to extend across the other end, there is still room for further lifting near the seal and the anchor, and the product structure is not compact enough.
- the wires for braiding the seal or the anchoring portion are each converged and connected by a connecting member.
- the converging is reflected in the structural features, and also includes the corresponding steps in the processing, that is, the multiple wires are gathered into one tie.
- the sealing portion or the anchoring portion is generally cut by a pipe, and the end of the pipe can be understood as a converging portion.
- the sealing portion is a bottom toward the side of the anchoring portion, the bottom portion of the sealing portion has a first converging, and the middle portion in the radial direction of the anchoring portion has a second converging, the first converging and the second converging The opposite direction extends and is misaligned.
- the reverse pulling of the first constriction and the second constriction relative to the connector may cause the seal portion and the anchor portion body portion to be close to each other until they are abutted. Build separate channels to avoid interference during traction and to facilitate assembly.
- first converging and the second converging are arranged side by side in a staggered arrangement or in an inner and outer nesting staggered arrangement.
- the two channels are arranged offset from each other, further avoiding interference during traction and facilitating assembly.
- the anchoring portion extends from the connecting member toward the sealing portion to form an extending portion, and the extending portion is folded away from the side of the connecting portion to the bottom of the sealing portion to form a folded-back portion, and the folded-back portion and the bottom portion of the sealing portion Offset.
- the anchoring portion is an everted structure as a whole, and the folded-back section forms a double-layer structure around the periphery of the extending section, and the double-layered structure has a certain space inside, which can absorb and allow the anchoring portion to deform after abutting the sealing portion, but does not weaken the same. Anchor effect.
- the anchoring portion extends from the connecting member toward the sealing portion to form an extending portion, and the extending portion is folded away from the side of the connecting portion to the bottom of the sealing portion to form a folded-back portion, and the folded-back portion is at the sealing portion.
- the inner folding opening at the bottom position forms a closing section which abuts against the bottom of the sealing portion.
- the folded-back section forms a closing section at the bottom position of the sealing portion, and the closing section abuts against the bottom of the sealing portion.
- the closing section extends substantially inwardly in the radial direction and forms a surface contact with the bottom of the sealing portion, which is more advantageous for applying a pre-tightening force.
- the anchoring portion and the sealing portion are both hollowed out structures, the so-called surface contact can be understood as a net. The abutment between the faces does not require physical contact.
- the first constriction is located at the center of the bottom of the seal.
- the closing portion abuts against the outer edge portion of the bottom portion of the sealing portion such that the pulling of the pre-tightening force causes the bottom portion of the sealing portion to be inverted.
- the closing section is suspended at or connected to the extension of the extension.
- “Suspend” means that there is no connection or just contact with the periphery of the extension section, and it can move freely relative to each other when deformed. If there is a connection, it can be a fixed connection or a sliding connection, and the rotation fits both to some extent. Relative movement.
- the extension section is tapered, and a large-head side (ie, a side of the cone bottom) is disposed away from the connecting member and is open.
- the extension is horn-shaped for easy recycling, and the flaring can also improve strength and structural stability.
- the anchoring portion has a predetermined type of state that is not abutted against the sealing portion and an abutting state that is in contact with the sealing portion.
- the connecting member is closer to the closing portion in the axial direction of the anchoring portion. Farther away from the seal.
- the closing portion first contacts the bottom portion of the sealing portion, and since the connecting member is still far away from the sealing portion, the distance also leaves a space for further pulling to form the pre-tightening force. And maybe.
- the connecting member in the abutting state, is flush with the closing portion in the axial direction of the anchoring portion or farther from the sealing portion than the closing portion.
- the connecting member includes an inner ring and an outer ring that are nested with each other, and one of the first converging and the second converging, one of which penetrates and fixes in the inner ring, and the other penetrates and Fixed in the gap between the inner ring and the outer ring.
- the connecting member includes an inner ring and an outer ring that are nested with each other, and one of the first converging and the second converging penetrating and fixing one of the inner ring and the outer ring, wherein The other one penetrates the inner ring and is fixed at the piercing end with a retaining head that abuts the connecting member.
- the connecting member comprises a body having two channels side by side, the first converging and the second converging respectively penetrating through the corresponding passages, and respectively fixing the anti-offset against the body at the piercing end head.
- the connector and the anti-off head may be stainless steel, nickel titanium alloy or other metal material that meets biocompatibility requirements.
- the anchor portion has a pressing portion that abuts against the sealing portion, the anchor portion has a cylindrical structure in a compressed state, and the abutting portion is on the inner wall side of the tubular structure.
- the anchor portion has a cylindrical structure in a compressed state, and the inner wall side of the tubular structure abuts against the seal portion in the released state.
- the originally abutting portion on the inner wall side is turned to the outside and faces the sealing portion, and abuts against the sealing portion.
- the anchoring portion and the sealing portion have a state of use in direct contact and abutment.
- the anchoring portion and the sealing portion may be in direct contact and abutting, but the direct contact and the abutting are not the only state of use, under the action of a special physiological structure, or after a period of use, the anchoring portion and the sealing portion
- the parts may also be distant from each other or even create gaps.
- the sealing portion has a two-layer structure, the bottom layer facing the anchor portion, the top layer facing away from the anchor portion, and the sealing portion being connected to the anchor portion through the bottom layer.
- the anchor portion partially passes through the sealing portion and is connected to the top of the sealing portion.
- the anchor portion is connected to the bottom portion of the sealing portion, and the sealing portion is more easily obtained when the anchor portion and the sealing portion abut each other. Pre-deformation, or higher deformation gain efficiency.
- the inside of the two-layer structure is provided with one or more layers of a flow-blocking film.
- the present invention is also preferably applied to the sealing portion of the two-layer structure.
- Both the disc shape and the column shape can be regarded as a two-layer structure with a built-in choke film.
- the anchoring portion and the sealing portion are separate structures; the anchoring portion and the sealing portion abut each other during assembly.
- the split structure is used, heat treatment is set separately, and then assembled, and the pre-deformation effect after the tightening can be obtained during the assembly process. If the integral structure is used, although the pressing effect can be obtained, since there is no assembly process, it is necessary to obtain the pressing effect after the heat setting, so that the heat setting process is required to be higher, and the anchoring portion and the sealing portion are generally required respectively. Heat treatment to increase the difficulty of processing.
- the anchoring portions are continuously distributed in the circumferential direction.
- the mesh or rod-like structure has a gap in the axial direction, it should be continuously distributed in the axial direction in terms of the overall structure and distribution, in order to obtain a more uniform force distribution and stable support, and to avoid providing support only by the circumferential part. .
- the portion of the anchoring portion that abuts the sealing portion is adjacent the outer edge of the anchoring portion.
- the portion of the sealing portion that abuts the anchor portion is adjacent to the outer edge of the sealing portion.
- the outer edge portions are more easily offset by axial deformation or radial convergence, and the deformation force is increased under the same force.
- the sealing portion and the anchoring portion are assembled after being heat-set, and the sealing portion and the anchoring portion have a first state of initial contact during assembly;
- connection portion between the sealing portion and the anchor portion also has a second state after a predetermined distance in the axial direction.
- the sealing portion In the first state, the sealing portion has been in contact with the anchoring portion, and since both the sealing portion and the anchoring portion have been heat-set, if the two are further moved in the axial direction, one of them will be deformed and in the second state. Maintain the stress caused by deformation.
- connection portion between the sealing portion and the anchor portion is located at a middle portion in the radial direction of the two, and in the first state, the sealing portion and the anchor portion are in contact with each other at a peripheral region of the connection portion.
- the stress mentioned above is also the source of the pre-tightening force. If there is no heat setting before, but is heat-set after assembly, the stress will disappear during the heat treatment and the required pre-tightening force cannot be produced.
- the sealing portion and the anchor portion obtain the relative positional relationship after assembly, and the second state does not perform heat treatment.
- the anchor Since the anchor has a better stiffness, the general stress is mainly generated by the deformation of the seal.
- the portion of the sealing portion that is connected to the anchor portion is closer to the anchor portion side.
- the distance between the sealing portion and the anchoring portion in the axial direction moves, which affects the magnitude of the stress, and therefore needs to be expressed and controlled in an adaptive manner during assembly.
- the predetermined distance is expressed as:
- a shape variable of a portion of the seal portion that is connected to the anchor portion is a shape variable of a portion of the seal portion that is connected to the anchor portion.
- the deformation amount is an axial change amount of a predetermined portion of the seal portion, or an angle between a predetermined portion of the seal portion and the axis of the seal portion.
- the predetermined portion of the sealing portion is a portion where deformation occurs when the first state transitions to the second state, and a portion having a relatively large deformation amount may be selected for ease of expression and measurement.
- the predetermined portion of the sealing portion is a portion where the sealing portion comes into contact with the anchor portion in the first state.
- the magnitude of the obtained stress can be corresponded.
- the axial overall elongation of the left atrial appendage occluder can be better overcome in the subsequent use, through the sealing portion and the anchoring portion.
- the superposition of the elasticity of the material and the pre-tightening force improves the restoring force and ensures the sealing effect for long-term use.
- the present invention also provides a method for preparing a left atrial appendage occluder, wherein the sealing portion and the anchoring portion are assembled after being heat-set, and the sealing portion and the anchoring portion are close to each other when assembled and in a first state when initially contacting; On the basis of the first state, the connection portion between the sealing portion and the anchor portion moves toward the second state by a predetermined distance in the axial direction;
- the joint between the seal portion and the anchor portion is fixed to each other, and the joint portion is maintained in the second state to complete the assembly.
- the sealing portion and the anchor portion have been in partial contact with each other in the first state, the axial position between the sealing portion as a whole and the anchor portion does not change when the first state to the second state transition, only partial The stress generated by the deformation.
- the present invention also provides a method of preparing the left atrial appendage occluder of the improved sealing effect, comprising preparing a sealing portion and an anchoring portion, and the sealing portion and the anchoring portion are tightly connected and abutted against each other through the connecting member.
- the left atrial appendage occluder according to the present invention is used to prevent the atrial fibrillation from forming a thrombus in the left atrial appendage by percutaneous puncture and transporting it to the left atrial appendage of the heart through a sheath. The risk of a stroke.
- the invention realizes a compact connection between the sealing portion and the anchoring portion through an improved connection manner, and maintains a certain pre-tightening force to make the sealing portion and the left atrial appendage adhere more tightly and block the left atrial appendage opening to reduce the internal leakage and residual shunt The incidence.
- FIG. 1 is a schematic view of a left atrial appendage occluder in the first embodiment
- FIG. 2 is a schematic view showing the heat sealing of the sealing portion in the first embodiment
- Figure 3 is a schematic view showing the heat setting of the anchor portion in the first embodiment
- Figure 4a is a schematic view showing the process of connecting the anchor portion and the sealing portion (on the side of the anchoring portion) in the first embodiment
- Figure 4b is an enlarged view of a portion A of Figure 4a;
- Figure 5 is a schematic view showing the process of connecting the anchor portion and the sealing portion (the side of the sealing portion) in the first embodiment
- Figure 6 is a schematic view showing the beginning of the docking of the anchoring portion and the sealing portion in the first embodiment
- Figure 7a is a schematic view showing the completion of the connection between the anchoring portion and the sealing portion in the first embodiment
- Figure 7b is a schematic view showing the connection between the sealing portion and the anchoring portion in the prior art
- Figure 7c is a partially omitted schematic view of Figure 7a;
- Figure 8 is a schematic view showing the sealing of the left atrial appendage occluder into the left atrial appendage in the first embodiment
- Figure 9a is a schematic view of the left atrial appendage occluder in the second embodiment
- Figure 9b is an enlarged view of a portion A of Figure 9a;
- Figure 10 is a schematic view showing the process of connecting the anchor portion and the sealing portion in the second embodiment
- Figure 11a is a schematic view of the left atrial appendage occluder in the third embodiment
- Figure 11b is an enlarged view of a portion A of Figure 11a;
- Figure 12a is a schematic view showing the process of connecting the anchor portion and the sealing portion in the third embodiment
- Figure 12b is an enlarged view of a portion A of Figure 12a;
- Figure 13 is a schematic view showing the process of connecting the anchor portion and the sealing portion in the third embodiment
- Figure 14 is a schematic view of the left atrial appendage occluder in the fourth embodiment
- FIG. 15 to FIG. 17 are schematic diagrams showing the release process of the anchoring portion in the fifth embodiment, wherein the sealing portion is illustrated in a state after being released;
- FIG. 21 to FIG. 25 are schematic diagrams of comparison before and after deformation of the disk bottom in the fifth embodiment.
- FIG. 28 are schematic diagrams of comparisons before and after deformation of another shape of the disk in the fifth embodiment.
- FIG. 29 to FIG. 30 are schematic diagrams of comparison before and after deformation of the disk bottom in the sixth embodiment.
- 31 to 40 are schematic front and rear views of the assembly of different connection modes in the seventh embodiment.
- Embodiment 1 is a diagrammatic representation of Embodiment 1:
- a left atrial appendage occluder 1000 includes a sealing portion 1100 and an anchoring portion 1200 that are connected to each other. Both the sealing portion 1100 and the anchoring portion 1200 are woven using a nickel-titanium wire.
- the sealing portion 1100 comprises a disk surface 1110, a waist portion 1120 and a disk bottom 1170. There is a plug head 1130 at the end of the disk surface, a PET blocking film 1140 is stitched in the disk surface, and a blocking film 1150 is stitched in the middle portion of the waist.
- the inner slit has a layer of flow blocking film 1160.
- the anchor portion is composed of an inner layer mesh cone 1210, an outer layer mesh cylinder 1220, an outer layer end bent portion 1230, an inner layer mesh cone 1210, and an outer circular mesh 1220 arc transition portion 1240.
- the outer mesh cylindrical portion 1220 is formed with a circular arc transition portion 1250 of the end bent portion 1230, and an evenly distributed barb 1270 is circumferentially disposed on the outer surface of the outer mesh cylindrical portion 1220.
- the inner layer mesh cone 1210 corresponds to the extension section; the outer layer mesh cylinder 1220 corresponds to the foldback section; the outer layer end bend section 1230 corresponds to the closure section.
- the distal end of the bottom of the sealing portion is connected to the tapered proximal end of the inner layer of the anchoring portion, and the connecting manner can be connected by rigid sleeve fastening or laser welding.
- the cylindrical woven nickel-titanium mesh is respectively fixed by high-temperature heat treatment of the mold.
- 2 and 3 are respectively a sealing portion 1100 and an anchoring portion 1200 after heat treatment of the left atrial appendage occluder 1000 in the first embodiment of the present invention, wherein the sealing portion 1100 has a distal nickel-titanium wire bundle, and the anchoring portion 1200 is inside.
- the layered mesh cone 1210 has a proximal nickel-titanium wire bundle.
- 4a-7 are a connection manner of the sealing portion 1100 and the anchoring portion 1200 of the left atrial appendage occluder 1000 in the first embodiment of the present invention.
- the proximal nickel-titanium wire 1261 of the anchoring portion is bundled between an outer steel sleeve 1262 (corresponding to the outer ring) and an inner steel sleeve 1263 (corresponding to the inner ring), which can be seen for knitting anchoring.
- the nickel-titanium wire is bundled at the proximal end of the extension and connected to the inner and outer steel sleeves as connectors.
- the inner and outer steel sleeves as the connecting members are farther away from the sealing portion than the closing portion, and the anchoring portion of the rolled structure is substantially in the shape of a bowl (or nest), and the connecting member is located in the bowl and sinks in the bowl.
- the inner and outer steel sleeves and the proximal nickel-titanium wire 1261 between them are fixed by welding or pressing, and the inner steel sleeve 1263 is a hollow structure, and then the outer steel sleeve is cut by shearing or laser processing. Nickel-titanium wire other than the 1262 proximal end is removed.
- the distal end nickel-titanium wire 1171 of the sealing portion passes through the inner layer steel sleeve 1263 after being bundled in the middle of the bottom of the disk, and a certain pulling force is applied to tightly connect the sealing portion 1100 and the anchoring portion 1200 to form a compact connection.
- the structure of the sealing portion is shown; the distal nickel-titanium wire 1171 of the sealing portion is fixed together by a steel sleeve 1172 (corresponding to the anti-off head), and the steel sleeve 1172 should slide and abut against the inner steel sleeve 1263.
- the end is fixed to the distal nickel-titanium wire 1171.
- the outer diameter of the steel sleeve 1172 is larger than the inner diameter of the inner steel sleeve 1263 to prevent the distal nickel-titanium wire 1171 from coming off the inner steel sleeve 1263.
- the excess distal nickel-titanium wire 1171 at the distal end of the seal is then sheared off or laser processed.
- the steel sleeve material of the present invention may be stainless steel, nickel titanium alloy or other metal material that meets biocompatibility requirements. In this embodiment, a stainless steel material is selected.
- the first state can be regarded as the first contact
- the sealing portion 1100 faces the anchoring portion 1200 as the distal nickel-titanium wire 1171 is further pulled in the axial direction.
- One side will gradually abut against the anchoring portion 1200 to generate stress, that is, the pre-tightening force, and the distal nickel-titanium wire 1171 is axially pulled by a predetermined distance to reach the second state, and then the sealing portion 1100 and the anchoring portion are further passed through the steel sleeve 1172.
- the portion 1200 remains in the second state, ie, the presence of stress is maintained.
- the axial pulling of the predetermined distance may be directly measured, or may be obtained according to the shape change of the sealing portion 1100 toward the side of the anchoring portion 1200, that is, the shape of the disc bottom 1170, and the tensile force or the sealing portion of the distal nickel-titanium wire 1171 may be directly measured.
- the shape change of the disc bottom 1170 can refer to the shape of the first state in the first state, and can also refer to the angle between the waist 1120 or the axis of the seal 1100 in different states.
- a PET blocking film 1140 is sutured in the disk surface of the left atrial appendage occluder sealing portion by suturing, and a PET blocking film is sutured in the middle of the waist portion of the sealing portion and the bottom of the disk. 1150, 1 layer PET flow blocking film 1160, as shown in Figure 1.
- the sealing portion 1100 is a cage structure having a certain internal space as a whole.
- the waist portion In a predetermined state, the waist portion is substantially cylindrical.
- the bottom portion and the closing portion of the disk are pressed against each other after assembly.
- the radially-side deformation of the distal end side has a certain taper to form a substantially rounded table structure, and the middle portion of the bottom of the disk also protrudes toward the anchoring portion side under the action of the pre-tightening force.
- the sealing portion 1100 has a connecting portion 1180
- the anchoring portion 1200 has a connecting portion 1280.
- the connecting portions of the sealing portion 1100 and the anchoring portion 1200 extend toward each other and are aligned with each other and extend to each other. After contact, it is fixed by welding or a hoop.
- the converging portion of each of the sealing portion 1100 and the anchoring portion 1200 is used as a connecting portion.
- the connecting portion of the sealing portion 1100 that is, the bundled distal nickel-titanium wire 1171 is composed of the disc bottom 1170. The convergence is formed, and the large-area disc bottom 1170 abruptly converges to form a fine constriction.
- the connecting portion of the anchoring portion 1200 i.e., the bundled proximal nickel-titanium wire 1261, gradually converges from the inner layer of mesh taper 1210 to form a fine constriction.
- the connecting portion of the anchoring portion 1200 is fixed between the outer steel sleeve 1262 and the inner steel sleeve 1263, and the connecting portion of the sealing portion 1100 passes through the inner steel sleeve 1263 and is fixed by the steel sleeve 1172.
- the steel sleeve 1172 is abutted against the distal end side of the inner steel sleeve 1263.
- the connecting portion of the sealing portion 1100 is in the central region, and the connecting portion of the anchoring portion 1200 is in the peripheral region thereof.
- the connecting portions of the person are staggered inside and outside and pass over the end portions of each other.
- the connecting portion of the anchoring portion 1200 and the connecting portion of the sealing portion 1100 are nested with each other, and the respective extending paths are straight lines, that is, the left atrial appendage occluder
- the axial extension due to the misalignment arrangement, has no spatial interference when extending, and as close as possible to the distance between the sealing portion 1100 and the anchoring portion 1200 until the peripheral regions of the joints of the two are in mutual abutment.
- connection portion of the anchor portion 1200 and the connection portion of the sealing portion 1100 overlap each other, and the connection portion of the sealing portion 1100 is at the anchor portion 1200.
- the connection portion of the sealing portion 1100 is at the anchor portion 1200.
- the sealing portion 1100 and the anchoring portion 1200 are integrally formed with the respective connecting portions.
- the split form may be adopted, that is, there is no converging extending in opposite directions, but the two are opposite each other.
- the connecting rods are fixed in the middle of the side, and one of the connecting rods has a hollow structure, and the connecting rod of the other is passed through, so that the inner and outer staggered fixed joints can also be realized.
- the left atrial appendage occluder is anchored in the left atrial appendage, and the anchoring portion is connected to the sealing portion.
- a pre-tightening force is formed between the two parts, and the structure of the waist of the left atrial appendage occluder 1120 can be better attached to the opening position of the left atrial appendage, and the pre-tightening force can adhere the sealing plate surface 1110 to the left atrial appendage.
- the 3-layer membrane effectively blocks blood flow into the left atrial appendage to reduce the incidence of endoleak.
- Embodiment 2 is a diagrammatic representation of Embodiment 1:
- the left atrial appendage occluder 2000 is composed of a sealing portion 2100 and an anchoring portion 2200.
- the structural shape of the sealing portion and the anchoring portion after heat setting is the same as that of the first embodiment.
- the difference from the first embodiment is that the anchoring portion and the sealing portion are connected in a different manner. This is shown in Figure 9a and Figure 9b.
- the left atrial appendage occluder 2000 heat-treats the sealed portion 2100 and the anchoring portion 2200, wherein the sealing portion 2100 has a distal nickel-titanium wire bundle, and the anchor portion 2200 has a proximal nickel-titanium wire bundle.
- the distal nickel-titanium wire 2171 of the sealing portion and the nickel-titanium wire 2261 at the proximal end of the anchor portion are respectively bundled and passed through a steel sleeve 2272 from the opposite direction (opposite direction) (equivalent On the connector body).
- a tensile force is applied to the two nickel-titanium wires in the direction indicated by the arrow in FIG. 10, so that the sealing disk 2100 and the anchoring portion 2200 are tightly connected to form a certain pre-tightening force, and the waist portion 2120 of the sealing portion is pulled by the pre-tightening force.
- the steel sleeve 2263 is fixed by pressing or welding, it is stuck on both sides of the steel sleeve 2272, and the excess nickel-titanium wire is cut off or processed by laser treatment.
- the sealing portion 2100 and the anchoring portion 2200 are also in a manner similar to the first embodiment, and have a unitary structure and oppositely extending connecting portions, except that the connecting portions of the two are staggered with each other. Take the orientation in the figure as an example. One is to the left and the other is to the right.
- Embodiment 3 is a diagrammatic representation of Embodiment 3
- the left atrial appendage occluder 3000 is composed of a sealing portion 3100 and an anchoring portion 3200.
- the structural shape of the sealing portion 3100 and the anchoring portion 3200 after heat setting is the same as that of the first embodiment and the second embodiment.
- the difference from the first embodiment and the second embodiment is that the anchoring portion and the sealing portion are connected differently. As shown in Figure 11a and Figure 11b.
- the left atrial appendage occluder 3000 heat-treats the sealed portion 3100 and the anchoring portion 3200, wherein the sealing portion 3100 has a distal nickel-titanium wire bundle, and the anchor portion 3200 has a proximal nickel-titanium wire bundle.
- . 12a to 13 are another connection manner of the sealing portion 3100 and the anchoring portion 3200 of the left atrial appendage occluder 3000 in the third embodiment of the present invention.
- the distal nickel-titanium wire 3171 of the sealing portion 3100 is bundled and passed between the outer steel sleeve 3172 and the inner steel sleeve 3173, and then welded or pressed.
- the steel sleeve 3172 and the nickel-titanium wire of the inner steel sleeve 3173 are fixed together, and the inner steel sleeve 3173 is a hollow structure, and then the nickel-titanium wire other than the distal end is removed by shearing or laser processing.
- the proximal nickel-titanium wire 3261 of the anchoring portion is converged and passes through the inner layer steel sleeve 3173 at the distal end of the sealing portion, penetrates into the middle of the mesh of the sealing portion, and can apply a certain pulling force to compactly connect the sealing portion and the anchoring portion to form a tight connection.
- the waist of the sealing portion is stretched into a tapered structure; then the proximal nickel-titanium tow of the anchoring portion is fixed together by a steel sleeve 3162, which is outside the steel sleeve 3162
- the diameter is larger than the inner diameter of the inner steel sleeve 3173 of the sealing portion, and the excess nickel-titanium wire at the proximal end of the anchoring portion is sheared off or laser-treated.
- Embodiment 4 is a diagrammatic representation of Embodiment 4:
- the sealing portion 4100 has a flat disk shape, that is, a sealing disk, and the central portion of the sealing disk is convex toward the anchoring portion under the action of the pre-tightening force.
- Embodiment 5 is a diagrammatic representation of Embodiment 5:
- This embodiment focuses on the release of the anchoring portion and the change of the shape of the sealing portion during the assembly process, and the specific structure of the anchoring portion and the sealing portion can be at least with any of the first to third embodiments without special description. One is combined.
- the left atrial appendage occluder of the present embodiment includes an interconnecting sealing portion 5100 and an anchoring portion 5200.
- the anchoring portion 5200 is compressed in the sheath tube before being released to facilitate passage through the body into the lesion site, and compression.
- the anchoring portion 5200 is in the shape of a cylinder, and the portion A is in the cylindrical inner wall.
- the anchoring portion 5200 is rolled up and released (the direction of the scrolling can be seen in the direction indicated by the arrow), the portion A is gradually turned outward by the cylindrical inner wall, and finally the sealing portion The bottom of the 5100 is offset.
- the sealing portion 1100 includes a disk surface, a waist portion, and a disk bottom 5110.
- the central portion of the disk bottom 5110 is bundled to form a distal nickel-titanium wire 5120, and the distal nickel-titanium wire 5120 passes through the connecting portion 5210 of the anchor portion. (for example, in the form of steel sleeves, etc.).
- the central portion of the disc bottom 5110 can be raised away from the anchor portion, as shown in FIG. 18; the central portion of the disc bottom 5110 can be flat, as shown in FIG. 19; the central portion of the disc bottom 5110 can also be anchored toward the anchor.
- the protrusion is as shown in Figure 20.
- the sealing portion and the anchoring portion are respectively processed and heat-treated to form the assembly, and the distal nickel-titanium wire 5120 is first passed through the connecting portion 5210 of the anchoring portion.
- the seal portion and the anchor portion are adjacent to each other in the axial direction.
- the first state is when the pre-tightening force has not been applied, and the central portion C of the disc bottom 5110 has a tendency to protrude toward the anchor portion, and then the distal nitinol wire 5120 is along the arrow direction of Fig. 23. Pulling downward, and the connecting portion 5210 of the anchoring portion moves upward relative to the direction of the arrow, and the central portion C is deformed by force until a predetermined deformation or pre-tightening force requirement is reached, and then the distal nickel-titanium wire 5120 is fixed by the anti-dropping head 5130. At this time, it is the second state. As shown in FIG. 24, the central region C is deformed in a substantially flat state.
- the change of the angle B or the axial change amount H of the central region C can be monitored when the pre-tightening force is applied, and the deformation of the central region C can be more clearly reflected by the comparison of FIG. 25, and the dotted line expresses the first The position of the middle area C in the state.
- the sealing portion and the anchoring portion are in a first state when the pre-tightening force is not applied, and the central portion C of the disc bottom 5110 has a back anchoring portion convex.
- the tendency is that the distal nickel-titanium wire is pulled downward during assembly, and the joint of the anchoring portion moves relatively upward, and the central portion C is deformed until it reaches a predetermined deformation or pre-tightening force, and then is fixed by the anti-off head.
- the distal nickel-titanium wire is in the second state at this time, and the waist portion of the sealing portion radially converges in the direction of the arrow in FIG.
- the left atrial appendage occluder includes a sealing portion 6100 and an anchoring portion 6200.
- the sealing portion 6100 is an inverted cone-shaped disc bottom 6110 toward a side of the anchor portion in the first state.
- the central portion of the disc bottom 6110 is converged to form a distal nitinol wire 6120, and the distal nitinol wire 6120 passes through a joint portion 6210 of the anchor portion 6200 (eg, in the form of a steel sleeve or the like).
- the middle portion of the disc bottom 6110 is further tapered toward the joint portion 6210, and the distal nitinol wire 6120 is locked in the axial position by the anti-off head 6130.
- This embodiment focuses on the different connection modes of the anchoring portion and the sealing portion, and the specific structure of the anchoring portion and the sealing portion can be combined with at least one of the other embodiments without special description.
- the left atrial appendage occluder includes a sealing portion 7100 and an anchoring portion 7200 that are connected to each other, and the sealing portion 7100 includes a disk surface, a waist portion, and a disk bottom 7110.
- the central portion of the disc bottom 7110 is shaped to converge to form a connecting portion, that is, the central portion is converged to form the distal nitinol wire 7120, and the central portion of the anchor portion is integrally converged to form a connecting portion, and the end portion thereof is connected.
- the member 7210 is fixed (for example, by using a steel sleeve).
- the distal nickel-titanium wire 7120 passes through the hollow portion of the connecting portion 7210 of the anchor portion and is relatively tensioned to form a pre-tightening force, and the anchor portion and the sealing portion abut against each other.
- the deformation of the central portion of the bottom is further raised toward the anchor portion.
- the distal nickel-titanium wire 7120 is fixed by the anti-detent head 7130 (for example, using a steel hoop), and the excess portion of the distal nickel-titanium wire 7120 is cut off to complete the assembly.
- the central region of the disc bottom 7110 is shaped to converge to form a connecting portion, that is, the central region is converged to form a distal nickel-titanium wire 7120, and the central portion of the anchor portion is generally converged in shape.
- the bundle forms a proximal nickel-titanium wire 7220, with a connector 7210 having two channels arranged side by side such that the distal nickel-titanium wire 7120 and the proximal nickel-titanium wire 7220 pass through the corresponding channels in opposite directions and are relatively tensioned.
- the pre-tightening force, the anchoring portion and the sealing portion abut against each other, and the central portion of the bottom of the disk is deformed further toward the anchoring portion, and finally the distal nickel-titanium wire 7120 is fixed by the anti-dropping head 7130 (for example, using a steel hoop), and then the shearing is performed.
- the excess portion of the distal nickel-titanium wire 7120 is removed; the proximal nickel-titanium wire 7220 is secured by a retaining head 7230 (eg, using a steel hoop), and the excess portion of the proximal nickel-titanium wire 7220 is sheared to complete the assembly.
- the central portion of the disc bottom 7110 is shaped to converge to form a connecting portion, and the end portion thereof is fixed by a connecting member 7140 (for example, a steel sleeve), and the central portion of the anchor portion is integrally converged. That is, the bundle forms a proximal nickel-titanium wire 7220, and the proximal nickel-titanium wire 7220 passes through the hollow region of the connecting member 7140 and is relatively tensioned to form a pre-tightening force, and the anchor portion and the sealing portion abut each other to deform the central portion of the bottom of the disk.
- a connecting member 7140 for example, a steel sleeve
- the proximal nickel-titanium wire 7220 is fixed by the anti-off head 7230 (for example, using a steel hoop), and the excess portion of the proximal nickel-titanium wire 7220 is cut off to complete the assembly.
- the central region of the disc bottom 7110 is shaped to converge to form a connecting portion, that is, the central region is converged to form a distal nitinol wire 7120, and the central portion of the anchoring portion is generally converged in shape.
- the bundle forms a proximal nickel titanium wire 7220.
- the direct connection between the distal nickel-titanium wire 7120 and the proximal nickel-titanium wire 7220 is omitted, that is, the connecting member is omitted, and the proximal nickel-titanium wire 7220 bolt is wrapped around the outer periphery of the nickel-titanium wire 7120 at a distance.
- the end of the nickel-titanium wire 7120 may be provided with an anti-drop head 7130 (for example, a steel hoop), and the end of the proximal nickel-titanium wire 7220 may be fixed by welding at the bottom of the sealing portion of the sealing portion, or may be a spiral shape in advance.
- the heat setting process overcomes the elastic expansion and rewinds the outer circumference of the distal nickel-titanium wire 7120 during winding. Moreover, the distal nickel-titanium wire 7120 can also be spirally wound with the proximal nickel-titanium wire 7220.
- the overall shape of the disc bottom 7110 converges to form a connecting portion, that is, the entire bundle is formed to form a distal nickel-titanium wire 7120, and the central portion of the anchor portion is integrally converged to form a connecting portion.
- the portion is fixed by a connecting member 7210 (for example, using a steel sleeve).
- the distal nickel-titanium wire 7120 When assembled, the distal nickel-titanium wire 7120 passes through the hollow portion of the connecting portion 7210 of the anchoring portion and is relatively tensioned to form a pre-tightening force, and finally the anti-dropping head 7130 is utilized (for example, The distal nickel-titanium wire 7120 is fixed by a steel hoop, and the excess portion of the distal nickel-titanium wire 7120 is cut off to complete the assembly.
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Abstract
一种改进密封效果的左心耳封堵器(1000,2000,3000,4000,5000,6000,7000)及其制备方法,该左心耳封堵器,包括相互连接的密封部(1100,2100,3100,4100,5100, 6100,7100)和锚定部(1200,2200,3200,5200,6200,7200),该密封部(1100,2100, 3100,4100,5100,6100,7100)和锚定部(1200,2200,3200, 5200,6200,7200)相互抵紧。可以通过施加预紧力的方式实现密封部(1100,2100,3100,4100,5100,6100,7100)与锚定部(1200,2200,3200,5200,6200,7200)的紧凑连接,封堵器(1000, 2000,3000,5000,6000,7000)释放后能更好的贴附和封堵左心耳口,提高密封性能,降低残余分流,提高左心耳封堵器的临床应用价值。
Description
本发明涉及医疗器械,具体涉及一种用于封堵左心耳的介入治疗器械以及制备方法。
心房颤动(简称房颤)是最常见的持续性心律失常。随着年龄增长房颤的发生率不断增加,75岁以上人群可达10%。房颤时心房激动的频率达300-600次/分,心跳频率往往快而且不规则,心房失去有效的收缩功能。房颤时左心耳收缩力下降,再加上左心耳自身的形态特点及其内的肌小梁凸凹不平,使得左心耳内血流产生漩涡和流速减慢,促使血栓形成。非瓣膜病房颤患者左房血栓90%以上存在于左心耳。血栓脱落后会通过主动脉血管进入脑部动脉血管形成脑栓塞即脑卒中。
针对房颤患者脑卒中的风险,临床上目前主要采用三种方法进行预防治疗,即抗凝药物治疗、外科手术治疗和经皮左心耳封堵治疗。抗凝药物治疗是指通过服用抗凝药物来抑制血液凝固,以降低左心耳内血栓形成的风险,进而减少脑卒中的发生概率。临床试验表明抗凝药物治疗可显著降低脑卒中的发生概率,但是抗凝药物治疗是一个漫长的过程,同时也存在明显的并发症,主要表现为出血并发症,并且可能出现较严重的情况。外科手术治疗包括外科手术切除或者缝合左心耳,但是外科手术创伤大,一般是在行瓣膜置换或者冠状动脉搭桥等其他手术时完成,患者一般难以接受单纯的左心耳外科手术,特别是高龄患者。经皮左心耳封堵治疗是指通过经皮穿刺的方式,利用一直径较小的输送鞘管,将一左心耳封堵器输送到位于心脏右心房的左心耳并释放。左心耳封堵器可将左心耳的开口位置封堵,心房内血流不能进入左心耳,因此不能形成血栓,从而达到预防心房颤动血栓栓塞的目的。从2001年开始,经皮左心耳封堵治疗开始投入使用,先后进行了动物实验和临床试验。临床试验表明,左心耳封堵术可有效降低房颤患者脑卒中的发生概率。
从结构上分,目前市场上左心耳封堵器主要分两种类型:塞子结构和双盘结构。
因左心耳封堵器的应用时间相对较短,技术相对不成熟,术后会出现一些并发症影响病人的生活质量;其中器械残余分流是左心耳封堵术的主要并发症之一,其中就塞子结构,从其6个月随访结果看,8%的病人存在残余分流并发症,从12个月的随访结果显示,不同中心32%~34.5%的病人存在某些程度的残余分流并发症;而双盘结构的左心耳封堵器,其不同中心6个月的临床随访结果看,2%~16.2%的病人存在中度残余分流并发症;残余分流并发症发生率较高,这将影响病人的生活质量,因此降低左心耳封堵器术后残余分流是提高左心耳封堵器临床应用价值的主要目标之一。
双盘结构的左心耳封堵器,通常是由一个密封部和一个锚定部组成,释放后密封部封堵左心耳开口位置,锚定部释放在左心耳内部且带有倒刺,起到固定密封部的作用。释放后左心耳封堵器的密封部要紧密贴合在左心耳开口位置,将左心耳口部封堵。如果密封部不能与左心耳口紧密贴合,可能造成密封部悬挂在左心房内,不能有效起到左心耳口部封堵的效果,且可能进一步增加血栓形成的风险。而造成密封部不能有效的贴附在左心耳口位置的一个主要因素与密封部和锚定部之间的连接方式有关,即:锚定部与密封部之间不能紧凑的连接在一起,产品的整体长度较长,释放后锚定部被径向压缩,进一步增加产品释放后的整体长度,同时可造成密封部与锚定部轴向距离加大,密封部释放后不能有效的贴附在左心耳口部,造成残余分流。
发明内容
本发明提出了一种左心耳封堵器,改进了密封部与锚定部的连接方式,可避免和延缓左心耳封堵器整体上轴向变长,进一步保证密封部贴附和封堵左心耳口。
一种改进密封效果的左心耳封堵器,包括相互连接的密封部和锚定部,所述密封部和锚定部相互抵紧。
密封部与锚定部的相互抵紧可理解为,密封部和锚定部至少有一部分相互接触,且由于抵紧力,使得密封部具有形变。
本发明中,可以通过施加预紧力的方式实现密封部与锚定部的紧凑连接,封堵器释放后能更好的贴附和封堵左心耳口,即使锚定部或密封部被径向压缩而加长,仍可以保持密封部与锚定部的贴靠,保证密封效果。
本发明涉及的左心耳封堵器可有效提高密封性能,降低残余分流。
结合现有技术,在密封部内设置有一张或多张阻流膜;在锚定部的周缘还可以进行覆膜,比如在锚定盘外表面上全部或部分覆膜。
在未特殊说明的前提下,本发明中所描述的形状以及位置关系均是左心耳封堵器在体内释放膨胀后的状态,也可简称释放状态或膨胀状态,在释放之前左心耳封堵器被压缩在输送装置内,可称为压缩状态或释放前状态。
可选的,所述密封部与锚定部各自独立的为线框结构或网状结构。
密封部与锚定部可分别通过编织或切割的方式加工而成,密封部(锚定部)可以采用规则或不规则的线框结构,采用线框结构时可根据需要在适宜的位置设置骨架以提高强度,骨架相对于其他部分可以是截面积的增大,或至少具有更高的强度,网状结构可以为规则或不规则的单元格,优选菱形或近似菱形的单元格,至少是可以在径向进行压缩,以便于回收和释放,网状结构具有明显的经纬结构,经纬交汇处可以是固定节点更优选采用非固定的方式,即经纬之间可以错位滑移,以提供顺应性和形变能力。
可选的,所述密封部为密封盘或密封塞。
此处的“盘”、“塞”理解为大致的形状特点,例如盘为扁平状,其外缘形状基本符合左心耳处的生理构造特点,例如圆形或根据实际需求的其他形状。
例如塞为具有一定厚度的柱状,例如近似圆柱、圆台等,但无论其外周还是母线的形状并不严格限制,一方面可参照现有技术,另一方面也可根据实际需求,就密封部自身的形状而言并非本发明改进重点,当然,本发明体提供了优选或改进的方案。
作为优选,所述密封部为密封盘,且具有未与锚定部接触的预定型状态以及与锚定部相互接触的抵紧状态;相对于预定型状态,抵紧状态的密封盘的盘底中部具有轴向朝锚定部的形变。
作为优选,相对于预定型状态,抵紧状态的密封盘的盘底中部具有轴向朝锚定部凸起的形变。
作为优选,所述密封部包括背向锚定部的盘面、朝向锚定部的盘底以及连接盘面和盘底的腰部,其中所述盘底为平底或盘底中部朝锚定部一侧凸起或盘底中部背向锚定部一侧凸起。
盘面、盘底以及腰部整体上构成笼形结构,一张或多张阻流膜可以设置在笼形结构内部,笼形结构除必要的镂空部位外可以是封闭或部分开放形式的,在编织加工密封部时,可在盘底和盘面有一收束端。
笼形结构由于内部具有一定空间,因此即使有一定形变也可以保证密封效果,尤为适用于本发明中与锚定部抵紧这一特点。
笼形结构的直径主要是腰部的直径与锚定部直径基本相当,而盘面直径略大于腰部的直径以提高端部的封堵效果。
可选的,所述密封部具有未与锚定部接触的预定型状态以及与锚定部相互接触的抵紧状态,所述盘底在预定型状态下的直径大于盘底在抵紧状态下的直径。
此处所述的盘面或盘底的直径,两者可近似为圆形,若为其他形状,可理解为截面积或整体粗细的相对关系,以圆形为例,由于盘面的直径大于盘底的直径,因此整体上为圆台形,其上部的顶面略大,越往下越收敛,下部的底面略小,这样在与锚定部相抵时,可顺应的与锚定部贴合。
可选的,所述密封部具有未与锚定部接触的预定型状态以及与锚定部相互接触的抵紧状态,相对于预定型状态,抵紧状态的密封部在腰部和/或盘底具有形变。
预定型状态是指密封部自身加工完成后在没有组装或不受外力作用下通过热定型获得的形状,组装后由于与锚定部抵紧,且为了提高或保持这个预紧力,因此在与锚定部抵紧后产生形变。
可选的,相对于预定型状态,抵紧状态的密封部在腰部具有径向收拢的形变。
当密封部与锚定部相互远离或受径向压缩时,所述径向收拢的形变可抵消或延缓轴向延伸的趋势,以保证左心耳开口部位的密封性。径向收拢的形变可使腰部产生一定的锥度,也更好的与左心耳贴合以提高密封效果。
可选的,相对于预定型状态,抵紧状态的密封部在盘底具有轴向朝锚定部凸起的形变。
相似的原理,所述轴向朝锚定部凸起的形变也可以抵消或延缓左心耳封堵器整体上在轴向的延伸。尽可能的保持密封部与锚定部的贴靠,保证密封效果。
可选的,所述密封部至少在盘底的外缘部位与锚定部相抵。盘底的外缘部位与锚定部相抵在相同预紧力的情况下可获得更大的密封部形变,更利于补偿和抵消轴向的延伸。
可选的,密封部和锚定部通过各自连接端交错连接。
可选的,密封部和锚定部各自收束并通过连接件相连。
本发明中,密封部和锚定部的收束可视为通过形状收敛构成的连接部,密封部和锚定部两者的连接部相向延伸并错位固定。
但通过形状收敛构成的连接部并不限于采用收束的方式,现有技术中,密封部和锚定部两者的连接部一般是相互对正,若直接连接则端面直接相抵,当然也可以采用过渡的连接件,这种结构会导致封堵器在整体上轴向长度过长,不利于密封。
本发明中密封部与锚定部的连接部错位布置,可在相向凑近的过程中避免空间干涉,大幅度的降低密封部和锚定部间距,提高密封效果。
可选的,所述密封部和锚定部与各自的连接部之间为一体结构,或相互固定的分体结构。
密封部和锚定部与各自的连接部之间可以在切割或者编织后为一体结构,或者连接部作为独立的部件,通过焊接等手段装配固定。优选方式是一体结构,便于加工也保证了整体强度。
可选的,所述形状收敛为整体收敛或局部收敛。
密封部和锚定部由于要封堵左心耳,因此具有一定的直径范围,而连接部直径较细,其间的直径变化可以是渐变或突变,例如采用整体收敛的方式时直径变化的位置呈现锥形结构,而局部收敛可以视为直径的突变,例如由较大的截面积突变成较细的杆或束。
可选的,所述密封部和锚定部两者上的连接部均为一处,并相互连接;或所述密封部和锚定部两者上的连接部为多处,且一一对应的相互连接。
连接部的数量和位置并没有严格限制,仅采用一处时,一般处在密封部或锚定部 中部。
可选的,所述密封部和锚定部两者的连接部直接相连或通过连接件相连。
直接相连,即两者的连接部相互接触,通过焊接、抱箍、相互缠绕等方式相互固定,而通过连接件相连则两者的连接部可能是并不相互接触,而是分别相对于连接件固定,连接件可以是一个单独部件或多个部件构成的组件。
可选的,所述密封部和锚定部两者的连接部均沿直线延伸;或
其中一者的连接沿直线延伸,另一者的延伸部沿曲线延伸;或
两者的连接部均沿曲线延伸。
密封部和锚定部两者相对布置,两者的连接部相互延伸凑近而连接,在延伸的过程中并不严格限制其路径,为了简化结构,优选的方式是密封部和锚定部两者的连接部均沿直线延伸。
连接部本身的形状既可能是简单的直杆也可能是较为复杂的三维结构,因此这里的直线延伸应理解为整体趋势,即延伸过程并没有整体上的迂回或折弯。
作为进一步的优选,密封部和锚定部两者的连接部均沿左心耳封堵器轴线方向延伸。
可选的,所述密封部和锚定部两者的连接部在相互配合的部位处,相互嵌套或相互偏离。
密封部和锚定部两者的连接部由于是错位布置,而相互嵌套或相互偏离均可以实现在错位的前提下继续延伸,而不发生空间干涉,此处的相互偏离是相对于嵌套而言,不应理解为相互远离,例如在垂直左心耳封堵器轴线的截面上,密封部和锚定部两者的连接部可以是相互贴靠或具有一定间隙。
可选的,所述密封部和锚定部两者的连接部相向延伸且越过对方的端头。
其中一连接部越过对方的端头后,也意味着另一连接部的端头越过已方的端头,这样两者的连接部在相互配合的部位处,沿垂直左心耳封堵器轴线方向的投影并排布置或至少部分重叠。
密封部和锚定部两者的连接部相互嵌套时,其投影也一定是重叠的,在相互偏离时,投影形状与视角有关,因此并排或部分重叠均可能,若密封部和锚定部尽管错位,但并没有继续延伸越过对方端头,则尚有进一步提拉靠近密封部和锚定部的空间,产品结构也不够紧凑。
若为网状结构,则用于编织密封部或锚定部的丝各自收束并通过连接件相连。该收束即体现为结构特征,也包含了加工时的相应步骤,即将多根丝汇聚成一扎。
若为线框结构,密封部或锚定部一般采用管材切割的方式,那么管材的端头可理解为收束部位。
可选的,密封部朝向锚定部一侧为底部,密封部的底部具有第一收束,锚定部的径向上的中部具有第二收束,所述第一收束和第二收束相向延伸并错位固定。
第一收束和第二收束相对于连接件的反向牵引可使得密封部和锚定部主体部分相互靠近直至抵紧。构建各自独立的通道可避免牵引时的干涉,也便于组装。
可选的,第一收束和第二收束并排交错布置或内外嵌套交错布置。总体而言两个通道是彼此错位布置的,进一步避免牵引时的干涉,也便于组装。
可选的,所述锚定部由连接件处背向密封部延伸构成延伸段,延伸段远离连接段的一侧外翻折返至密封部的底部构成折返段,该折返段与密封部的底部相抵。
锚定部整体为外翻结构,折返段环绕在延伸段的外围形成双层结构,双层结构内部具有一定的空间,可以吸收并容许锚定部抵紧密封部之后发生形变,但不削弱其锚定效果。
可选的,所述锚定部由连接件处背向密封部延伸构成延伸段,延伸段远离连接段的一侧外翻折返至密封部的底部构成折返段,所述折返段在密封部的的底部位置处内折收口形成收口段,该收口段与密封部的底部相抵。
所述折返段在密封部的的底部位置处内折收口形成收口段,该收口段与密封部的底部相抵。
收口段大致沿径向朝内延伸,与密封部的底部形成面接触,更有利于施加预紧力,尽管锚定部与密封部均为镂空结构,但此处所谓的面接触可理解为网面之间的贴靠,并不要求实体上的面接触。
可选的,第一收束位于密封部的底部中央。而收口段向上抵靠密封部的底部的外缘部位,这样通过预紧力的牵拉可使得密封部的底部呈倒锥形。
可选的,所述收口段悬浮在延伸段的外围或与延伸段连接。
“悬浮”即与延伸段的外围并没有连接关系或仅仅是有所接触,彼此形变时可自由相对移动,若有连接,可以是固定连接或滑动,转动配合,均在一定程度上束缚两者相对运动方式。
可选的,所述延伸段为锥形,其大头一侧(即锥底一侧)远离连接件且开口设置。
延伸段为喇叭状可便于回收,扩口处也可以提高强度和结构的稳定性。
可选的,所述锚定部具有未与密封部抵紧的预定型状态以及与密封部相互接触的抵紧状态,预定型状态下,在锚定部轴向上所述连接件比收口段更远离密封部。
即密封部与锚定部相对靠近时,收口段与密封部的底部先接触,由于连接件与密封部较远仍有一段距离,这段距离也为进一步的牵拉形成预紧力留有空间和可能。
可选的,抵紧状态下,在锚定部轴向上所述连接件与收口段相平齐或比收口段更远离密封部。
可选的,所述连接件包括相互嵌套的内环和外环,所述第一收束和第二收束中,其中一者穿入并固定在内环中,另一者穿入并固定在内环与外环的间隙中。
可选的,所述连接件包括相互嵌套的内环和外环,所述第一收束和第二收束中,其中一者穿入并固定在内环与外环的间隙中,其中另一者贯穿内环并在穿出端固定有与连接件相抵的防脱头。
可选的,所述连接件包括具有并排两个通道的本体,所述第一收束和第二收束分别贯穿对应的通道,并在穿出端分别固定有与所述本体相抵的防脱头。
所述连接件以及防脱头可为不锈钢、镍钛合金或者其他符合生物相容性要求的金属材料。
作为优选,锚定部具有与密封部相抵紧的抵紧部位,锚定部在压缩状态下为筒状结构,且所述抵紧部位处在筒状结构的内壁侧。
作为优选,锚定部在压缩状态下为筒状结构,释放状态下筒状结构的内壁侧抵靠密封部。
在释放后,由于锚定部向外翻卷,因此原本处在的内壁侧抵紧部位经翻卷后处在外侧且朝向密封部,并与密封部相抵紧。
压缩状态下,若抵紧部位处在筒状结构的外壁侧则需要采用更为复杂的翻卷方式,否则难以兼顾在锚定部获大的外径以支撑和锚定左心耳内壁。
但在采用复杂翻卷的形式下,可以改变锚定部末端(压缩状态的远端)释放时外扩的趋势,可以避免戳伤左心耳内壁,相对提高安全性。
作为优选,所述锚定部和密封部具有直接接触并抵紧的使用状态。
正常使用状态下,锚定部与密封部可能是直接接触并抵紧,但直接接触并抵紧并非唯一的使用状态,在特殊生理构造的作用下,或使用一段时间后,锚定部与密封部 之间也可能相互远离甚至产生间隙。
作为优选,所述密封部为双层结构,朝向锚定部的为底层,背向锚定部的为顶层,密封部通过底层与锚定部相连。
相对的情况是锚定部局部穿过密封部并与密封部的顶部相连,本发明中锚定部与密封部的底部相连,在锚定部与密封部相互抵紧时更容易获得密封部的预形变,或者说具有更高的形变获得效率。
作为进一步优选,所述双层结构的内部设有一层或多层阻流膜。
由于密封部采用双层结构时更容易在轴向发生松溃拉长,因此本发明也优选适用在双层结构的密封部。无论是盘形还是柱状均可视为双层结构,且内置阻流膜。
作为优选,所述锚定部和密封部为分体结构;所述锚定部和密封部在装配过程中相互抵紧。
采用分体结构,分别热处理定型,再进行装配,并在装配过程中可以获得抵紧后的预形变效果。若采用一体结构虽然也可以获得抵紧效果,但由于并没有装配过程因此需要在热定型后就获得抵紧效果,因此对热定型工艺提出更高要求,一般需要对锚定部和密封部分别热处理,提高处理难度。
为了获得较好的支撑和锚定效果,所述锚定部在周向上连续分布。
尽管网或杆状结构在轴向上会有间隙,在整体结构和分布上看在轴向上应连续分布,以争取更均匀的受力分布和稳定支撑,避免仅靠周向的局部提供支撑。
作为优选,锚定部抵靠密封部的部位邻近锚定部的外边缘。
作为优选,密封部抵靠锚定部的部位邻近密封部的外边缘。
外边缘部位相抵更容易获得轴向的形变或径向的收敛,在同等受力下提高形变量。
作为优选,所述密封部与锚定部完成热定型后进行装配,装配时密封部与锚定部具有初始接触的第一状态;
密封部与锚定部之间的连接部位还具有沿轴向相向运动预定距离后的第二状态。
第一状态下密封部与锚定部已经且刚刚接触,由于密封部与锚定部都已经完成热定型,因此如果两者进一步沿轴向相向运动其中一者会产生形变并在第二状态下保持有形变带来的应力。
作为优选,所述密封部与锚定部之间的连接部位分别位于两者径向的中部,第一状态下所述密封部与锚定部之间在连接部位的外围区域相接触。
上述的应力也是所述预紧力的来源,若之前没有热定型,而是装配后再热定型,那么应力会在热处理的时候消失,无法产生所需要的预紧力。
因此需要强调的是,第二状态下,所述密封部与锚定部即获得装配后的相对位置关系,第二状态后不再进行热处理。
由于锚定部具有更好的刚度,因此一般应力的产生主要来源于密封部的形变。
作为优选,相对于第一状态,在第二状态中密封部上与锚定部连接的部位更朝向锚定部一侧凑近。
转入第二状态时,密封部与锚定部之间的连接部位沿轴向相向运动的距离,影响了应力的大小,因此在装配时需要以适应的方式进行表达并相应控制。
作为优选,所述预定距离的表达方式为:
密封部与锚定部之间的连接部位的轴向作用力;或
密封部与锚定部之间的接触部位的压力;或
密封部上与锚定部连接的部位的形变量。
所述形变量为密封部预定部位的轴向变化量、或密封部预定部位与密封部轴线的 夹角。
所述密封部预定部位为第一状态向第二状态转变时发生形变的部位,为了便于表达和测量,可以选择形变量相对较大的部位。例如所述密封部预定部位为第一状态下密封部与锚定部接触的部位。
装配时通过检测预定距离的表达方式的变化量,可以对应到所获得的应力大小。
若没有所述应力的存在,即使装配时密封部与锚定部有局部接触,但使用过程中当左心耳封堵器轴向整体拉长,即密封部与锚定部相互远离时,密封部与锚定部之间内在的回复力较小,仅仅是靠各自材料的弹性来克服轴向整体拉长。
本发明中,通过先热定型、后装配且装配时保留轴向应力的方式,可以在后续的使用过程中更好的克服左心耳封堵器轴向整体拉长,通过密封部与锚定部材料的弹性与预紧力的叠加来提高回复力,保证了长期使用的封堵效果。
相应的本发明还提供一种左心耳封堵器的制备方法,密封部与锚定部完成热定型后进行装配,装配时密封部与锚定部相互凑近且初始接触时为第一状态;在第一状态基础上,密封部与锚定部之间的连接部位沿轴向相向运动预定距离后达到第二状态;
将密封部与锚定部之间的连接部位相互固定,使连接部位保持在第二状态完成装配。
由于第一状态下密封部与锚定部已经相互局部接触,因此第一状态到第二状态转变时,密封部作为整体可能与锚定部之间的轴向位置并没有改变,仅仅是局部的形变产生的应力。
本发明还提供了一种所述的改进密封效果的左心耳封堵器的制备方法,包括制备密封部和锚定部,将密封部和锚定部通过连接件紧凑连接且相互抵紧。
本发明所述的左心耳封堵器,通过经皮穿刺的方式,通过输送鞘管将其输送到心脏左心耳的位置,将左心耳封堵,以预防房颤患者在左心耳内形成血栓进而导致中风的风险。
本发明通过改进的连接方式实现密封部与锚定部紧凑连接,并保持一定的预紧力能够让密封部与左心耳贴附的更加紧密和封堵左心耳开口,以降低内漏和残余分流的发生率。
图1为实施例一中的左心耳封堵器的示意图;
图2为实施例一中密封部热定型后的示意图;
图3为实施例一中锚定部热定型后的示意图;
图4a为实施例一中锚定部与密封部连接过程(锚定部一侧)的示意图;
图4b为图4a中A部分放大图;
图5为实施例一中锚定部与密封部连接过程(密封部一侧)的示意图;
图6为实施例一中锚定部与密封部开始对接的示意图;
图7a为实施例一中锚定部与密封部连接完成的示意图;
图7b为现有技术中密封部与锚定部的连接示意图;
图7c为图7a的局部省略示意图;
图8为实施例一中左心耳封堵器放入左心耳内封堵的示意图;
图9a为实施例二中的左心耳封堵器的示意图;
图9b为图9a中A部分放大图;
图10为实施例二中锚定部与密封部连接过程的示意图;
图11a为实施例三中的左心耳封堵器的示意图;
图11b为图11a中A部分放大图;
图12a为实施例三中锚定部与密封部连接过程的示意图;
图12b为图12a中A部分放大图;
图13为实施例三中锚定部与密封部连接过程的示意图;
图14为实施例四中的左心耳封堵器的示意图;
图15~图17为实施例五中锚定部释放过程示意图,图中密封部以释放后状态示意;
图18~图20为实施例五中不同盘底形状的密封部的示意图;
图21~图25为实施例五中盘底变形前后的对照示意图;
图26~图28为实施例五中另一形状盘底变形前后的对照示意图;
图29~图30为实施例六中盘底变形前后的对照示意图;
图31~图40为实施例七中不同连接方式的装配前后示意图。
实施例一:
如图1所示,本发明实施例一左心耳封堵器1000包括相互连接的密封部1100和锚定部1200。密封部1100与锚定部1200均采用镍钛丝编织而成。
密封部1100包括盘面1110、腰部1120和盘底1170组成,在盘面端部有栓头1130,盘面内缝有1层PET阻流膜1140,腰部中部内缝有1层阻流膜1150,盘底内缝有1层阻流膜1160。
锚定部由内层网状锥形1210、外层网状圆柱形1220、外层端部弯折部分1230、内层网状锥形1210与外层网状圆柱形1220的圆弧过渡部分1240、以及外层网状圆柱形1220与端部弯折部分1230的圆弧过渡部分1250组成,在外层网状圆柱形1220外表面周向有均匀分布的倒刺1270。
其中内层网状锥形1210相当于延伸段;外层网状圆柱形1220相当于折返段;外层端部弯折部分1230相当于收口段。
密封部盘底远端与锚定部内层网锥形近端连接在一起,该连接方式可以通过刚套紧固或激光焊接的方式连接在一起。
密封部与锚定部在连接之前,分别是采用圆柱形编织镍钛网通过模具高温热处理定型而成。图2、图3分别是本发明实施例一中左心耳封堵器1000热处理定型后的密封部1100和锚定部1200,其中密封部1100有一远端镍钛丝收束,锚定部1200内层网状锥形1210有一近端镍钛丝收束。
图4a~图7是本发明实施例一中左心耳封堵器1000的密封部1100和锚定部1200的一种连接方式。
锚定部的近端镍钛丝1261收束在一外层钢套1262(相当于外环)和一内层钢套1263(相当于内环)之间,图中可见即用于编织锚定部的镍钛丝在延伸段的近端收束,并与作为连接件的内外层钢套相连。图4a中可以看出,作为连接件的内外层钢套,比收口段更远离密封部,翻卷结构的锚定部大体上为碗(或巢)形,连接件位于碗内即沉在碗口下方。
然后通过焊接或者压紧方式将内外层钢套和其之间的近端镍钛丝1261固定在一起,内层钢套1263为一中空结构,然后通过剪掉或激光处理方式将外层钢套1262近端以外的镍钛丝去掉。
如图5和图6,密封部的远端镍钛丝1171在盘底的中部收束后穿过内层钢套1263,可施加一定的拉力将密封部1100和锚定部1200紧凑连接,形成一定的预紧力,并通 过这个预紧力使得密封部的腰部拉伸成一个锥度的结构,同时可降低左心耳封堵器的整体高度。
如图7所示密封部结构形态;将密封部的远端镍钛丝1171通过钢套1172(相当于防脱头)固定在一起,钢套1172应滑动并抵紧内层钢套1263的远端后与远端镍钛丝1171固定。此钢套1172外径大于内层钢套1263的内径,防止远端镍钛丝1171脱出内层钢套1263。
之后将密封部远端多余的远端镍钛丝1171剪掉或激光方式处理掉。本发明所述的钢套材料可为不锈钢、镍钛合金或者其他符合生物相容性要求的金属材料,本实施例选用不锈钢材料。
装配过程中,密封部1100和锚定部1200相互凑近时,刚刚接触时可视为第一状态,随着远端镍钛丝1171轴向的进一步牵拉,密封部1100朝向锚定部1200的一侧会与锚定部1200逐渐抵紧产生应力即预紧力,远端镍钛丝1171轴向牵拉预定距离后到达第二状态,此时再通过钢套1172将密封部1100和锚定部1200保持在第二状态,即保持应力的存在。
轴向牵拉预定距离即可以直接测量,也可以根据密封部1100朝向锚定部1200的一侧即盘底1170的形状变化表达获得,还可以直接测量远端镍钛丝1171的拉力或密封部1100和锚定部1200之间的拉力。
盘底1170的形状变化既可以参照自身在第一状态的形状,还可以参照不同状态下与腰部1120或密封部1100轴线的夹角。
对比图6与图7a可明显得知,第一状态下(在图6基础上密封部1100和锚定部1200进一步凑近接触,但由于是刚刚接触,因此密封部1100的形状并没有变化,因此可参照图6形状。)盘底1170与腰部1120大致垂直,而图7a的第二状态下,盘底1170与腰部1120的夹角增大,盘底1170径向的中部进一步朝锚定部1200一侧凸起,因此通过夹角变化也可以表达和控制远端镍钛丝1171轴向拉动的预定距离。
密封部1100与锚定部1200连接后,通过缝合的方式,在左心耳封堵器密封部盘面内缝合一层PET阻流膜1140,密封部腰部中间及盘底分别缝合1层PET阻流膜1150、1层PET阻流膜1160,如图1所示。
密封部1100整体上为具有一定内部空间的笼形结构,在预定型状态下,腰部大致为圆柱状,对比图2和图7可以看出,组装后盘底部位与收口段相互抵紧,腰部远端侧径向收拢变形带有一定锥度,形成大致为倒圆台结构,不仅如此在预紧力的作用下,盘底中部也朝锚定部一侧凸起。
参见图7b,现有技术中密封部1100带有连接部1180,锚定部1200带有连接部1280,密封部1100和锚定部1200两者的连接部相向延伸且相互对正,延伸至相互接触后通过焊接或环形箍等方式进行固定。
图中可见密封部1100和锚定部1200之间有较大间隙,密封效果有待改进。
本实施例中,密封部1100和锚定部1200各自的收束部位即作为连接部,结合图5可见,密封部1100的连接部,即收束后的远端镍钛丝1171由盘底1170收敛形成,由较大面积的盘底1170突变收敛,形成较细的收束。
结合图4a可见,锚定部1200的连接部,即收束后的近端镍钛丝1261由内层网状锥形1210逐渐收敛形成较细的收束。
参见图7c,完成装配后,锚定部1200的连接部固定在外层钢套1262和内层钢套1263之间,而密封部1100的连接部穿过内层钢套1263后由钢套1172固定,钢套1172抵紧内层钢套1263的远端一侧,从该连接方式可以看出,密封部1100的连接部处在 中央区域,锚定部1200的连接部处在其外围区域,两者的连接部内外交错,且越过彼此的端头部位。
沿左心耳封堵器轴向即图7c中A方向投影看,锚定部1200的连接部与密封部1100的连接部相互嵌套,各自的延伸路径均为直线,即沿左心耳封堵器轴向延伸,由于是错位布置,在各自延伸时没有空间上的干涉,尽可能的拉近密封部1100和锚定部1200的距离,直至相互在两者的连接部外围区域相互抵紧。
沿垂直左心耳封堵器轴线方向即图7c中B方向投影看,锚定部1200的连接部与密封部1100的连接部相互重叠,且密封部1100的连接部处在锚定部1200的连接部的投影区域内。
本实施例中,密封部1100和锚定部1200与各自的连接部都是一体结构,不仅如此,还可以采用分体形式,即并没有相向延伸的收束,而是两者在相向的一侧中部都固定有连接杆,其中一者的连接杆为空心结构,另一者的连接杆从中穿过,这样也可以实现内外交错的固定连接。
如图8所示,通过经皮导管输送系统将本实施例左心耳封器1000输送到左心耳内后,该左心耳封堵器锚定在左心耳内,锚定部与密封部的连接方式使得两部分之间形成一预紧力,该左心耳封堵器腰部1120锥度的结构能够更好的与左心耳的开口位置贴附,预紧力能够让密封部盘面1110与左心耳贴附的更加紧密,使得3层覆膜有效的阻挡血流流入左心耳内,以降低内漏的发生率。
实施例二:
本发明实施例二左心耳封堵器2000由密封部2100和锚定部2200组成,密封部与锚定部热定型后的结构形状与实施例一相同。与实施例一的不同在于锚定部与密封部的连接方式不同。如图9a和图9b所示。
本发明实施例二中左心耳封堵器2000热处理定型后的密封部2100和锚定部2200,其中密封部2100有一远端镍钛丝收束,锚定部2200有一近端镍钛丝收束。
如图10所示,本实施例中密封部的远端镍钛丝2171以及锚定部的近端的镍钛丝2261各自收束后从相对的方向(相向)穿过一钢套2272(相当于连接件本体)。
沿图10中箭头所示方向分别对两束镍钛丝施加拉力,使密封盘2100和锚定部2200紧凑连接,形成一定的预紧力,并通过这个预紧力使得密封部的腰部2120拉伸成一个锥度的结构;然后如图9b,可将锚定部的近端的镍钛丝2261经钢套2172通过压紧或者焊接方式固定在一起,将密封部的远端镍钛丝2171经钢套2263通过压紧或者焊接方式固定在一起后,再卡在钢套2272两侧,并将多余的镍钛丝剪掉或通过激光处理的方式处理掉。
参见图9b,本实施例中密封部2100和锚定部2200也采用与实施例一类似的方式,具有一体结构且相向延伸的连接部,不同在于两者的连接部是相互偏离的方式交错,以图中方位为例,一者靠左,另一者靠右。
同样可以避免相向延伸时的空间干涉,将密封部2100和锚定部2200尽可能的相互拉近。
实施例三:
本发明实施例三中左心耳封堵器3000由密封部3100和锚定部3200组成,密封部3100与锚定部3200热定型后的的结构形状与实施例一、实施例二相同。与实施例一、实施例二的不同在于锚定部与密封部的连接方式不同。如图11a和图11b所示。
本发明实施例三中左心耳封堵器3000热处理定型后的密封部3100和锚定部3200,其中密封部3100有一远端镍钛丝收束,锚定部3200有一近端镍钛丝收束。图12a~图13是本发明实施例三中左心耳封堵器3000的密封部3100和锚定部3200的另一种连接方式。
本实施例中左心耳封堵器3000中,密封部3100的远端镍钛丝3171收束并穿过外层钢套3172和内层钢套3173之间,然后通过焊接或者压紧方式将外层钢套3172和内层钢套3173的镍钛丝固定在一起,内层钢套3173为一中空结构,然后通过剪掉或激光处理方式将远端以外的镍钛丝去掉。
锚定部的近端镍钛丝3261收束并穿过密封部远端的内层钢套3173,穿入密封部的网中间,可施加一定的拉力将密封部和锚定部紧凑连接,形成一定的预紧力,并通过这个预紧力使得密封部的腰部拉伸成一个锥度的结构;然后将锚定部的近端镍钛丝束通过钢套3162固定在一起,此钢套3162外径大于密封部内层钢套3173的内径,并将锚定部近端多余的镍钛丝剪掉或激光处理掉。
实施例四:
本实施例与实施例一的不同在于密封部4100的形状,如图14所示。
本实施例中密封部4100为扁平的盘状,即密封盘,在预紧力的作用下,密封盘中部朝向锚定部一侧凸起。
实施例五:
本实施例重点示意了锚定部释放以及在装配过程中密封部形状的变化,锚定部以及密封部具体结构,在没有特殊说明的情况下,可与实施例一~实施例三中的至少一者相结合。
参见图15~图17,本实施例中左心耳封堵器包括相互连接的密封部5100以及锚定部5200,锚定部5200在释放前压缩在鞘管内以便于在体内穿行进入病灶部位,压缩状态下锚定部5200为筒状,部位A处在筒状内壁,随着锚定部5200翻卷释放(翻卷方向可参见箭头指示方向),部位A逐渐由筒状内壁外翻,最终与密封部5100的盘底部位相抵。
参见图18~图20,密封部1100包括盘面、腰部和盘底5110,盘底5110的中心区域收束形成远端镍钛丝5120,远端镍钛丝5120穿过锚定部的连接部位5210(例如采用钢套等形式)。
在不同的实施方式中,盘底5110的中部区域可以背向锚定部凸起,如图18;盘底5110的中部区域可以平底,如图19;盘底5110的中部区域还可以朝向锚定部凸起,如图20。
以上均为盘底5110没有装配完成,即尚未施加预紧力时的形状特点,施加预紧力后,盘底5110的中部区域均有不同程度的形变,总体上朝锚定部进一步靠拢。
参见图21~图25,以其中一种盘底形状为例,密封部与锚定部各自加工并热处理定型后开始装配,先将远端镍钛丝5120穿过锚定部的连接部位5210使得密封部与锚定部沿轴向相互靠近。
如图22,刚接触尚没有施加预紧力时为第一状态,此时盘底5110的中部区域C具有背向锚定部凸起的趋势,然后远端镍钛丝5120沿图23箭头方向向下拉动,而锚定部的连接部位5210则相对沿箭头方向向上运动,中部区域C受力形变直至达到预定的形变或预紧力要求,再利用防脱头5130固定远端镍钛丝5120,此时即为第二状态,如图24,中部区域C受力形变基本呈平底状态。
为了控制装配过程,可在施加预紧力的时候监控角度B的变化或中部区域C的轴向变化量H,中部区域C受力形变通过图25对比可更明显的体现,虚线表达了第一状态下中部区域C的位置。
参见图26~图28,在另一实施方式中,密封部与锚定部刚接触尚没有施加预紧力时为第一状态,此时盘底5110的中部区域C具有背向锚定部凸起的趋势,装配时远端镍钛丝向下拉动,而锚定部的连接部位则相对向上运动,中部区域C受力形变直至达到预定的形变或预紧力要求,再利用防脱头固定远端镍钛丝,此时即为第二状态,中部区域C受力形变时密封部的腰部沿图27箭头方向径向收敛,在第二状态下连同盘底部整体上呈倒锥状,通过图28对比可更明显的体现,虚线表达了第一状态下腰部以及中部区域C的位置。
实施例六:
参见图29和图30,本实施例中左心耳封堵器包括密封部6100与锚定部6200,密封部6100在第一状态下朝向锚形部的一侧为倒锥状的盘底6110,盘底6110中心区域收束形成远端镍钛丝6120,远端镍钛丝6120穿过锚定部6200的连接部位6210(例如采用钢套等形式)。
装配后的第二状态下,盘底6110的中部进一步凑近连接部位6210锥度加大,远端镍钛丝6120通过防脱头6130锁定轴向位置。
实施例七:
本实施例重点示意了锚定部以及密封部不同的连接方式,锚定部以及密封部具体结构,在没有特殊说明的情况下,可与其他实施例中的至少一者相结合。
本实施例附图中,左心耳封堵器包括相互连接的密封部7100以及锚定部7200,密封部7100包括盘面、腰部和盘底7110。
图31、图32中,盘底7110的中心区域形状收敛形成连接部,即中心区域收束形成远端镍钛丝7120,锚定部的中部整体上形状收敛形成连接部,其端部通过连接件7210(例如采用钢套)固定,装配时远端镍钛丝7120穿过锚定部的连接件7210的中空部位并相对拉紧形成预紧力,锚定部以及密封部相互抵紧后盘底的中部区域形变进一步朝锚定部凸起,最后利用防脱头7130(例如采用钢箍)固定远端镍钛丝7120,再剪去远端镍钛丝7120的多余部分完成装配。
另外的实施方式中,参见图33、图34,盘底7110的中心区域形状收敛形成连接部,即中心区域收束形成远端镍钛丝7120,锚定部的中部整体上形状收敛,即收束形成近端镍钛丝7220,利用带有两个并排布置的通道的连接件7210,使得远端镍钛丝7120和近端镍钛丝7220沿相反方向穿过对应的通道并相对拉紧形成预紧力,锚定部以及密封部相互抵紧后盘底的中部区域形变进一步朝锚定部凸起,最后利用防脱头7130(例如采用钢箍)固定远端镍钛丝7120,再剪去远端镍钛丝7120的多余部分;利用防脱头7230(例如采用钢箍)固定近端镍钛丝7220,再剪去近端镍钛丝7220的多余部分完成装配。
另外的实施方式中,参见图35、图36,盘底7110的中心区域形状收敛形成连接部,其端部通过连接件7140(例如采用钢套)固定,锚定部的中部整体上形状收敛,即收束形成近端镍钛丝7220,近端镍钛丝7220穿过连接件7140的中空区域并相对拉紧形成预紧力,锚定部以及密封部相互抵紧后盘底的中部区域形变进一步朝锚定部凸 起,利用防脱头7230(例如采用钢箍)固定近端镍钛丝7220,再剪去近端镍钛丝7220的多余部分完成装配。
另外的实施方式中,参见图37、图38,盘底7110的中心区域形状收敛形成连接部,即中心区域收束形成远端镍钛丝7120,锚定部的中部整体上形状收敛,即收束形成近端镍钛丝7220。
远端镍钛丝7120和近端镍钛丝7220之间采用直接连接的方式,即省去了连接件,图中可见近端镍钛丝7220螺栓缠绕在远端镍钛丝7120外周,在远端镍钛丝7120端部可设置防脱头7130(例如采用钢箍),近端镍钛丝7220的端部可以采用焊接的方式固定在密封部的盘底部位,还可以是其螺旋形状预先热定型处理,缠绕时克服其弹性展开并重新绕置在远端镍钛丝7120外周,不仅如此,远端镍钛丝7120也可以采用螺旋方式,与近端镍钛丝7220互绕。
另外的实施方式中,参见图39、图40,盘底7110整体形状收敛形成连接部,即整体收束形成远端镍钛丝7120,锚定部的中部整体上形状收敛形成连接部,其端部通过连接件7210(例如采用钢套)固定,装配时远端镍钛丝7120穿过锚定部的连接件7210的中空部位并相对拉紧形成预紧力,最后利用防脱头7130(例如采用钢箍)固定远端镍钛丝7120,再剪去远端镍钛丝7120的多余部分完成装配。
以上公开的仅为本发明的具体实施例,但是本发明并非局限于此,本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。显然这些改动和变型均应属于本发明要求的保护范围保护内。此外,尽管本说明书中使用了一些特定的术语,但这些术语只是为了方便说明,并不对本发明构成任何特殊限制。
Claims (34)
- 一种改进密封效果的左心耳封堵器,包括相互连接的密封部和锚定部,其特征在于,所述密封部和锚定部相互抵紧。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部与锚定部各自独立的为线框结构或网状结构。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部为密封盘或密封塞。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部包括背向锚定部的盘面、朝向锚定部的盘底以及连接盘面和盘底的腰部,其中所述盘底为平底或盘底中部朝锚定部一侧凸起或盘底中部背向锚定部一侧凸起。
- 如权利要求4所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部具有未与锚定部接触的预定型状态以及与锚定部相互接触的抵紧状态,所述盘底在预定型状态下的直径大于盘底在抵紧状态下的直径。
- 如权利要求4所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部具有未与锚定部接触的预定型状态以及与锚定部相互接触的抵紧状态,相对于预定型状态,抵紧状态的密封部在腰部和/或盘底具有形变。
- 如权利要求6所述的改进密封效果的左心耳封堵器,其特征在于,相对于预定型状态,抵紧状态的密封部在腰部具有径向收拢的形变。
- 如权利要求6所述的改进密封效果的左心耳封堵器,其特征在于,相对于预定型状态,抵紧状态的密封部在盘底具有轴向朝锚定部凸起的形变。
- 如权利要求6所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部至少在盘底的外缘部位与锚定部相抵。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,密封部和锚定部通过各自连接端交错连接。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,密封部和锚定部各自收束并通过连接件相连。
- 如权利要求11所述的改进密封效果的左心耳封堵器,其特征在于,密封部朝向锚定部一侧为底部,密封部的底部具有第一收束,锚定部的径向上的中部具有第二收束,所述第一收束和第二收束相向延伸并错位固定。
- 如权利要求12所述的改进密封效果的左心耳封堵器,其特征在于,第一收束和第二收束并排交错布置或内外嵌套交错布置。
- 如权利要求12所述的改进密封效果的左心耳封堵器,其特征在于,所述锚定部由连接件处背向密封部延伸构成延伸段,延伸段远离连接段的一侧外翻折返至密封部的底部构成折返段,所述折返段在密封部的底部位置处内折收口形成收口段,该收口段与密封部的底部相抵。
- 如权利要求14所述的改进密封效果的左心耳封堵器,其特征在于,第一收束位于密封部的底部中央。
- 如权利要求14所述的改进密封效果的左心耳封堵器,其特征在于,所述收口段悬浮在延伸段的外围或与延伸段连接。
- 如权利要求13所述的改进密封效果的左心耳封堵器,其特征在于,所述延伸段为锥形,其大头一侧远离连接件且开口设置。
- 如权利要求14所述的改进密封效果的左心耳封堵器,其特征在于,所述锚定部具有未与密封部抵紧的预定型状态以及与锚密封部相互接触的抵紧状态,预定型状态下,在锚定部轴向上所述连接件比收口段更远离密封部。
- 如权利要求18所述的改进密封效果的左心耳封堵器,其特征在于,抵紧状态 下,在锚定部轴向上所述连接件与收口段相平齐或比收口段更远离密封部。
- 如权利要求12所述的改进密封效果的左心耳封堵器,其特征在于,所述连接件包括相互嵌套的内环和外环,所述第一收束和第二收束中,其中一者穿入并固定在内环中,另一者穿入并固定在内环与外环的间隙中。
- 如权利要求12所述的改进密封效果的左心耳封堵器,其特征在于,所述连接件包括相互嵌套的内环和外环,所述第一收束和第二收束中,其中一者穿入并固定在内环与外环的间隙中,另一者贯穿内环并在穿出端固定有与连接件相抵的防脱头。
- 如权利要求12所述的改进密封效果的左心耳封堵器,其特征在于,所述连接件包括具有并排两个通道的本体,所述第一收束和第二收束分别贯穿对应的通道,并在穿出端分别固定有与所述本体相抵的防脱头。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部为密封盘,且具有未与锚定部接触的预定型状态以及与锚定部相互接触的抵紧状态;相对于预定型状态,抵紧状态的密封盘的盘底中部具有轴向朝锚定部的形变。
- 如权利要求23所述的改进密封效果的左心耳封堵器,其特征在于,相对于预定型状态,抵紧状态的密封盘的盘底中部具有轴向朝锚定部凸起的形变。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,锚定部在压缩状态下为筒状结构,释放状态下筒状结构的内壁侧抵靠密封部。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,锚定部抵靠密封部的部位邻近锚定部的外边缘。
- 如权利要求25所述的改进密封效果的左心耳封堵器,其特征在于,密封部抵靠锚定部的部位邻近密封部的外边缘。
- 如权利要求1所述的改进密封效果的左心耳封堵器,其特征在于,所述锚定部和密封部为分体结构;所述锚定部和密封部在装配过程中相互抵紧。
- 如权利要求28所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部与锚定部完成热定型后进行装配,装配时密封部与锚定部具有初始接触的第一状态;密封部与锚定部之间的连接部位还具有沿轴向相向运动预定距离后的第二状态。
- 如权利要求29所述的改进密封效果的左心耳封堵器,其特征在于,所述密封部与锚定部之间的连接部位分别位于两者径向的中部,第一状态下所述密封部与锚定部之间在连接部位的外围区域相接触。
- 如权利要求30所述的改进密封效果的左心耳封堵器,其特征在于,相对于第一状态,在第二状态中密封部上与锚定部连接的部位更朝向锚定部一侧凑近。
- 如权利要求29所述的改进密封效果的左心耳封堵器,其特征在于,所述预定距离的表达方式为:密封部与锚定部之间的连接部位的轴向作用力;或密封部与锚定部之间的接触部位的压力;或密封部上与锚定部连接的部位的形变量。
- [根据细则26改正12.06.2018]
如权利要求32所述的改进密封效果的左心耳封堵器,其特征在于,所述形变量为密封部预定部位的轴向变化量、或密封部预定部位与密封部轴线的夹角。 - 一种改进密封效果的左心耳封堵器的制备方法,其特征在于,密封部与锚定部完成热定型后进行装配,装配时密封部与锚定部相互凑近且初始接触时为第一状态;在第一状态基础上,密封部与锚定部之间的连接部位沿轴向相向运动预定距离后达到第二状态;将密封部与锚定部之间的连接部位相互固定,使连接部位保持在第二状态完成装配。
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EP18805444.9A EP3632349A4 (en) | 2017-05-23 | 2018-05-18 | LEFT ATRIAL APPENDIX OCCCLUSION DEVICE WITH IMPROVED SEALING PERFORMANCE AND ITS MANUFACTURING METHOD |
US16/693,007 US11540836B2 (en) | 2017-05-23 | 2019-11-22 | Left atrial appendage occluder for improving sealing effect and manufacturing method thereof |
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EP (1) | EP3632349A4 (zh) |
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EP2968878B1 (en) | 2013-03-13 | 2020-08-12 | Conformal Medical, Inc. | Devices for excluding the left atrial appendage |
JP7071350B2 (ja) | 2016-10-27 | 2022-05-18 | コンフォーマル・メディカル・インコーポレイテッド | 左心耳を排除するためのデバイスおよび方法 |
CN111870286B (zh) * | 2020-07-24 | 2024-07-16 | 广东脉搏医疗科技有限公司 | 一种无铆型封堵器 |
EP3949876A1 (en) * | 2020-08-03 | 2022-02-09 | St. Jude Medical, Cardiology Division, Inc. | Devices and methods for the treatment of vascular abnormalities |
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EP3632349A1 (en) | 2020-04-08 |
CN108938034A (zh) | 2018-12-07 |
US11540836B2 (en) | 2023-01-03 |
EP3632349A4 (en) | 2021-03-03 |
US20200085445A1 (en) | 2020-03-19 |
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