CN113057708B - Left atrial appendage occlusion device - Google Patents
Left atrial appendage occlusion device Download PDFInfo
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- CN113057708B CN113057708B CN202110447440.1A CN202110447440A CN113057708B CN 113057708 B CN113057708 B CN 113057708B CN 202110447440 A CN202110447440 A CN 202110447440A CN 113057708 B CN113057708 B CN 113057708B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/1204—Type of occlusion temporary occlusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12036—Type of occlusion partial occlusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
- A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
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Abstract
本发明公开了一种左心耳封堵装置，包括：递送导管；抽吸导管设置在递送导管内，抽吸导管一端连接抽吸端口，抽吸端口能够与左心房壁贴合形成气密通道；抽吸端口的一端设有紧固件，紧固件用于将左心耳结扎；抽吸导管内设有可释放和收回的支撑架，支撑架用于支撑左心耳；支撑过滤器套设于支撑架的近心端，为可径向塌陷的网状支架，支撑过滤器用于支撑左心耳的内壁且能够捕获血栓。本发明使用支撑架配合抽吸装置使左心耳部分内陷，支撑架可根据释放位置的左心耳内侧壁的形态产生自适应变化，保证在施加抽吸压力过程中，左心耳内壁按照预定的方式有序地塌陷并进入左心房中。使用支撑过滤器有利于在回撤支撑架过程中捕获陷入其中的血栓。
The present invention discloses a left atrial appendage occlusion device, comprising: a delivery catheter; a suction catheter is arranged in the delivery catheter, one end of the suction catheter is connected to a suction port, and the suction port can be fitted with the left atrium wall to form an airtight passage; a fastener is provided at one end of the suction port, and the fastener is used to ligate the left atrial appendage; a releasable and retractable support frame is provided in the suction catheter, and the support frame is used to support the left atrial appendage; a support filter is sleeved on the proximal end of the support frame, and is a radially collapsible mesh support, and the support filter is used to support the inner wall of the left atrial appendage and can capture thrombus. The present invention uses a support frame to cooperate with a suction device to make the left atrial appendage partially inward, and the support frame can produce adaptive changes according to the morphology of the inner wall of the left atrial appendage at the release position, so as to ensure that during the process of applying suction pressure, the inner wall of the left atrial appendage collapses in an orderly manner and enters the left atrium in a predetermined manner. The use of a support filter is conducive to capturing the thrombus trapped in the support frame during the withdrawal of the support frame.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a left auricle plugging device.
Background
3300 Thousands of people worldwide suffer from stroke annually, 20% of which are caused by non-valvular atrial fibrillation (NVAF), a life threatening arrhythmia condition. Under the sinus rhythm of a normal person, the left auricle rarely forms thrombus due to the normal contractility, and when the auricle is in atrial fibrillation, the left auricle obviously increases, and the effective regular contraction is lost, so that blood is deposited on the left auricle, and thrombus is extremely easy to form. 90% of strokes in non-valvular atrial fibrillation patients are caused by these thrombi following blood passage through the aorta to the brain.
Anticoagulation is currently the standard method for preventing complications of atrial fibrillation and stroke, but there is a limit to anticoagulation, such as that some patients cannot be anticoagulated due to anticoagulation contraindication or relative contraindication, or that anticoagulants are easily affected by drugs and foods to increase detection trouble, so that some patients cannot adhere to anticoagulation for a long time. In addition, anticoagulation therapy itself has bleeding complications, which reduce the long-term anticoagulation adherence rate of patients and limit the effectiveness of anticoagulation therapy.
Cardiac surgery is simple and easy to remove or ligate the closed left atrial appendage simultaneously, so many doctors claim to remove or ligate the closed left atrial appendage simultaneously for such patients in need of cardiac surgical treatment. However, the surgical trauma is large for simply cutting or ligating the closed left atrial appendage and is not suitable for surgical procedures. Odell (Oracle) et al in 1996 reported a technique for preventing atrial fibrillation embolism by sealing the left atrial appendage via thoracoscopy, which has received great attention due to greatly reduced surgical trauma and risk. However, when performing a transthoracoscopic left atrial appendage closure procedure, an incision in the chest cavity is still required, which is more invasive.
The interventional left auricle plugging operation is a new method for preventing thromboembolism of patients with atrial fibrillation by non-drug, and has the action principle that a plugging device is delivered into the left auricle from a catheter through a blood vessel, the left auricle and the left auricle blood flow are blocked by the plugging device, thrombus generated by the left auricle is prevented from entering the atrium, and after a period of time, the surface of the plugging device is endothelialized, so that the problem that the thrombus of the left auricle enters the left atrium is solved, and the risk of stroke is reduced. As the inner wall of the left auricle is attached with rich pectinate muscles and myotrabeculae, the inner wall is thinner, the left auricle of different people is different in depth, the left auricle is mostly in a non-circular flat structure, and the left auricle and the inner cavity of the left auricle are at a certain bending angle. Due to the complex structure of the left atrial appendage, it is difficult to completely close it by means of the currently marketed instruments, and blood clots may leak from the gap between the instrument and the left atrial appendage to the brain. Another risk of these devices is that thromboembolism associated with the device may form due to foreign body implants left in the heart, and that some implanted occlusion devices also present a risk of falling off after implantation in the body, constituting a great safety hazard.
In view of this, there is an urgent need to improve the existing left atrial appendage occlusion device to ensure that the occlusion effect is good, the patient is less harmed and there is no risk of falling off.
Disclosure of Invention
The invention discloses a left auricle plugging device which is used for solving the problem that the left auricle plugging device is difficult to completely plug the left auricle in the prior art, and the plugging device has a falling risk.
In order to solve the problems, the invention adopts the following technical scheme:
there is provided a left atrial appendage occlusion device comprising:
A delivery catheter for introduction into a human body through a blood vessel;
The suction catheter is arranged in the delivery catheter, one end of the suction catheter is connected with a suction port, and the suction port can be attached to the left atrial wall to form an airtight channel;
The suction port is provided with a fastener at one end far away from the suction catheter, and the fastener is used for ligating the left atrial appendage;
a releasable and retractable support frame is arranged in the suction catheter and is used for supporting the left auricle;
The support filter is sleeved at the proximal end of the support frame and is a net-shaped support capable of collapsing radially, and the support filter is used for supporting the inner wall of the left auricle and can capture thrombus.
In the above scheme, the support frame is from gathering the state to the expansion state after releasing from the suction catheter, just the support frame can take place adaptive deformation when supporting left auricle, the support frame after expanding can with the inside wall laminating of left auricle.
In the above scheme, the support frame includes center pin and many connecting rods, the connecting rod diverges outward from the radial of center pin and extends.
In the above scheme, the connecting rod comprises a first supporting rod, a second supporting rod and a third supporting rod, wherein the first supporting rod is connected with the central shaft, the second supporting rod is connected with the first supporting rod, the third supporting rod is connected with the second supporting rod, two first supporting rods and two second supporting rods form a quadrilateral, and one end of the third supporting rod, which is far away from the central shaft, is bent.
In the above scheme, the support filter comprises a plurality of elastic rods, the elastic rods extend outwards in a radial direction and encircle to form the support filter, a through hole is formed in the bottom of the support filter, and a first film is arranged on the support filter.
In the above aspect, the support frame and the support filter may be movable in the axial direction, respectively.
In the scheme, a first guide piece is arranged in the suction catheter and is connected with the supporting frame for releasing and recovering the supporting frame, and a second guide piece is also arranged in the first guide piece and is connected with the supporting filter for releasing and recovering the supporting filter.
In the above scheme, the suction port is a net structure, the second film is arranged on the periphery of the suction port, and the suction port can collapse radially and be accommodated in the delivery catheter.
In the above aspect, the end of the suction port remote from the delivery catheter is flared.
In the above aspect, the fastener includes an elastic collar and a holding member, the elastic collar being releasably disposed on the suction port by the holding member.
In the above aspect, the elastic ferrule includes a suture thread, an engagement element and a locking element, the engagement element is disposed at one end of the suture thread, the locking element is disposed in a plurality and uniformly distributed on the suture thread, and each locking element is used for penetrating the engagement element and being fastened.
In the above aspect, the engagement element is a ring or a sleeve.
In the above aspect, the locking member includes a first end portion and a second end portion, the first end portion having a smaller dimension than the second end portion, the first end portion and the second end portion being capable of passing through the engagement member in sequence.
In the above-mentioned scheme, a breakpoint portion is arranged on the suture thread and is used for separating the suture thread portion after the fastener ligates the left atrial appendage.
In the above scheme, a cutting device is arranged in the delivery catheter.
The technical scheme adopted by the invention can achieve the following beneficial effects:
(1) The support frame is matched with the suction device to enable the left auricle to be partially sunken, the support frame has excellent shape self-adaptation, and can generate self-adaptation change according to the specific anatomical shape of the specific inner side wall of the left auricle at the release position, so that the support frame fully contacts the inner wall of the distal end of the left auricle, and the support frame is suitable for the left auricle with shallow opening or multi-leaf anatomical shape, thereby ensuring that the inner wall of the left auricle orderly collapses and enters the left atrium according to a preset mode in the process of applying suction pressure.
(2) The fastener adopts ligation type fastening to effectively prevent the fastener from falling off, and the fastening effect is good, and the left auricle of different shapes can be used, and the application scope is wide.
(3) The support frame is also provided with a support filter, so that thrombus trapped in the support frame is captured by the support filter in the process of withdrawing the support frame, and the effectiveness and safety of left auricle plugging are improved.
(4) Through the axial displacement of first guide piece and second guide piece control support frame and support filter respectively, when getting into left auricle, support frame and support filter interval increase, the interval reduces when retrieving support frame and support filter, is favorable to the thrombus of guide capture to get into the bottom of support filter, captures the effect better, and the safety in utilization of device obtains promoting.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments are briefly described below to form a part of the present invention, and the exemplary embodiments of the present invention and the description thereof illustrate the present invention and do not constitute undue limitations of the present invention. In the drawings:
FIG. 1 is a schematic view of a left atrial appendage occlusion device as disclosed in example 1 of the present invention;
fig. 2 is a schematic view of a support frame of a left atrial appendage occlusion device as disclosed in example 1 of the present invention;
FIG. 3 is a front view of a support filter of the left atrial appendage occlusion device disclosed in example 1 of the present invention;
FIG. 4 is a top view of a support filter of the left atrial appendage occlusion device disclosed in example 1 of the present invention;
FIG. 5 is a schematic view of an elastic collar of a left atrial appendage occlusion device as disclosed in another preferred embodiment of the present invention;
FIG. 6 is a schematic view of a delivery catheter of a left atrial appendage occlusion device as disclosed in another preferred embodiment of the present invention;
FIG. 7 is a schematic view of the left atrial appendage occlusion device of example 1 of the present invention placed in the left atrial appendage;
FIG. 8 is a schematic view of the left atrial appendage occlusion device of example 1 of the present invention in use;
FIG. 9 is a schematic illustration of the left atrial appendage ligation disclosed in example 1 of the present invention;
FIG. 10 is a schematic view of a left atrial appendage occlusion device as disclosed in example 2 of the present invention;
FIG. 11 is a schematic view of the left atrial appendage occlusion device of example 2 of the present invention placed in the left atrial appendage;
FIG. 12 is a schematic view of the left atrial appendage occlusion device of example 2 of the present invention in use;
fig. 13 is a schematic view showing the retraction of the support frame and the support filter in the left atrial appendage occlusion device disclosed in example 2 of the present invention.
The method specifically comprises the following reference numerals:
Suction catheter-10, left atrial appendage-20, scaffold-30, fastener-40, delivery catheter-50, support filter-60, suction port-11, central shaft-31, first strut-32, second strut-33, third strut-34, first guide-35, elastic collar-41, cutting device-51, first membrane-61, second guide-62 suture-411, engagement element-412, locking element-413, breakpoint-414.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to specific embodiments of the present invention and corresponding drawings. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1
As shown in fig. 1, 7 and 8, the left atrial appendage occlusion device provided by the present invention includes:
The device comprises a delivery catheter 50 for introducing into a human body through a blood vessel, a suction catheter 10 arranged in the delivery catheter 50, wherein one end of the suction catheter 10 is connected with a suction port 11, the suction port 11 can be attached with the left atrium wall to form an airtight channel, the suction port 11 is provided with a fastener 40 at one end far away from the suction catheter 10, and the fastener 40 is used for ligating the left atrial appendage 20. The suction catheter 10 is internally provided with a releasable and recyclable support frame 30, the support frame 30 is used for supporting the left auricle 20, the support frame 30 is changed into an unfolding state from a gathering state after being released from the suction catheter 10, the support frame 30 can be adaptively deformed when supporting the left auricle 20, and the unfolded support frame 30 can be attached to the inner side wall of the left auricle 20. The left auricle 20 is supported by the support frame 30, the left auricle 20 is not required to be sucked and sunk into the left atrium, the suction time is short, and the device is applicable to left auricles with different shapes. The central shaft 31 of the support frame 30 is sleeved with a support filter 60, and the support filter 60 can support the inner wall of the left atrial appendage 20 and can capture thrombus. The thrombus inside the left atrial appendage 20 can be prevented from entering the left atrium during the operation of the device, and the thrombus trapped therein can be captured by the support filter 60 during the retraction of the support frame 30, thereby improving the effectiveness and safety of the left atrial appendage occlusion.
A first guide 35 is provided in the suction catheter 10 in connection with the support frame 30 for releasing and retrieving the support frame 30.
Specifically, the support frame 30 extends through the suction port 11 into the left atrium and expands to a predetermined shape to effectively support the left atrial appendage wall. Thus, when pressure is applied to the left atrial appendage 20 by the suction device, the portion of the left atrial appendage wall of the distal end of the left atrial appendage 20 that is supported by the support frame 30 does not immediately collapse into the left atrium, the unsupported tissue of the distal end of the left atrial appendage 20 and tissue adjacent the left atrial appendage opening preferentially collapse, and the tissue adjacent the left atrial appendage 20 opening preferentially collapses into the left atrium, and more left atrial appendage tissue subsequently collapses in order during retraction of the support frame 30 by manipulation of the first guide 35.
The support 30 has excellent morphology adaptation and is adapted to the specific anatomical morphology of the specific inner sidewall of the left atrial appendage 20 in the released position such that the support 30 is in sufficient contact with the inner wall of the left atrial appendage, particularly for use with left atrial appendages having shallow or multi-lobular anatomical morphology, to ensure that the inner wall of the left atrial appendage collapses orderly and into the left atrium in a predetermined manner during the application of suction pressure.
As shown in fig. 2, the support frame 30 includes a central shaft 31 and a plurality of connecting rods divergently extending radially outward from the central shaft 31.
Specifically, the connecting rod includes a first strut 32, a second strut 33 and a third strut 34, the first strut 32 is connected with the central shaft 31, the second strut 33 is connected with the first strut 32, the third strut 34 is connected with the second strut 33, the two first struts 32 and the two second struts 33 form a quadrangle, so that the support 30 can be extended along the length direction of the suction catheter 10 or expanded outwards along the radial direction of the suction catheter 10, the support 30 can be received in the suction catheter 10, and the diameter of the support 30 can be expanded outwards to be larger than that of the suction catheter after the support is released. The third struts 34 are bent at one end away from the central axis 31 and the tips are curled inwardly to form a generally petal-shaped three-dimensional structure. The joint part of the left auricle 20 and the supporting frame 30 is curved, so that the tip is prevented from contacting the left auricle 20. The first strut 32, the second strut 33 and the third strut 34 are all formed by integrally laser cutting medical metal tubing with elasticity and shape memory characteristics and shaping by heat treatment.
In this embodiment, the flexibility of the first strut 32 is greater than or equal to the flexibility of the second strut 33, and the flexibility of the second strut 33 is greater than the flexibility of the third strut 34, so that the whole support 30 has both high flexibility and high resilience, can adapt to the inner cavities of the left atrial appendage in different anatomical forms, and has excellent shape adaptability. When the suction pressure applied in the inner cavity of the left auricle is received, the sequence of the adaptive deformation of each part of the support frame 30 is that the first support rod 32, the second support rod 33 and the third support rod 34 are adopted, so that tissues close to the opening of the left auricle 20 collapse preferentially into the left atrium, the unordered collapse of the tissues on the inner wall of the left auricle 20 into the left atrium is prevented, and the closing effect of the left auricle 20 is influenced.
As shown in fig. 3 and 4, the support filter 60 is configured such that a through hole is provided in the middle of the support filter 60, a plurality of elastic rods extend radially outward through the through hole and surround to form the support filter 60, a first film 61 is provided on the support filter 60, and the outer circumference can be bonded to the inner wall of the left atrial appendage 20. The first membrane 61 is a gas permeable membrane, and is capable of filtering blood in the left atrial appendage to intercept thrombus, and is suitable for the left atrial appendage 20 with different shapes and ensures the filtering effect.
The aspiration port 11 is a mesh structure peripherally provided with a second membrane and is configured to extend from the delivery catheter 50 or retract into the delivery catheter 50. The second membrane has good sealing performance, so that the suction port 11 can be attached to the left atrium wall to form an airtight channel.
In this embodiment, the suction port 11 is preferably flared away from the suction catheter 10. Which facilitates engagement to the left atrial wall around the left atrial appendage 20 opening.
The fastener 40 preferably comprises an elastic collar 41 and a retaining element (not shown in the figures) by means of which the elastic collar 41 is releasably arranged on the suction port 11. After the retaining element releases the elastic collar 41, the elastic collar 41 radially narrows and thickens, enabling fastening to the invaginated left atrial appendage tissue.
The application method of the left atrial appendage occlusion device provided by the embodiment is as follows:
The delivery catheter 50 is introduced into the human body through the blood vessel until reaching the left atrium, the suction catheter 10 is extended from the delivery catheter 50, the suction port 11 is extended from the suction catheter 10 and engaged to the left atrial wall around the opening of the left atrial appendage 20, the scaffold 30 and the supporting filter 60 are extended from the suction port 11, the suction device starts sucking, the left atrial appendage 20 is recessed with the profile of the scaffold 30, the scaffold 30 and the supporting filter 60 are withdrawn into the delivery catheter 50, the holding element on the fastener 40 is released, the elastic collar 41 is sleeved on the recessed left atrial appendage and becomes radially smaller under the elastic deformation restoration, and the left atrial appendage 20 is fastened and ligated. The suction port 11 is withdrawn into the delivery catheter 50 and the delivery catheter 50 is then removed from the body, as shown in fig. 9, completing the left atrial appendage occlusion procedure.
As shown in fig. 5, in another preferred embodiment, the elastic collar 41 includes a suture 411, an engaging element 412 and a locking element 413, the engaging element 412 is disposed at one end of the suture 411, the locking element 413 is disposed in plurality and uniformly distributed on the suture 411, and each locking element 413 can pass through the engaging element 412 and be snapped and fixed under a tensile force.
Preferably, the suture 411 is elastic in this embodiment. Has good ligature fastening effect. The engagement element 412 is a ring or sleeve. The locking element 413 comprises a first end and a second end, the first end having a smaller dimension than the second end, the first end and the second end being capable of passing through the engagement element in sequence. The locking element 413 is provided in the shape of a truncated cone or cone. The locking element 413 is facilitated to pass through the engagement element 412 and can be prevented from being disengaged after passing through the engagement element 412, i.e. the tightening process of the elastic collar 41 is irreversible, preventing disengagement.
In this embodiment, the suture 411 is preferably provided with a break 414 for separating the excess portion of the suture 411 after the fastener 40 ligates the left atrial appendage 20. And the excess suture 411 is withdrawn from the body, avoiding excess suture 411 remaining in the body. And the cutting is performed again without other devices, so that the operation is convenient.
Specifically, after the suction of the left atrial appendage 20 is completed, the supporting frame 30 and the supporting filter 60 are withdrawn into the delivery catheter 50, the holding element on the fastener 40 is released, the elastic collar 41 is sleeved on the recessed left atrial appendage, the suture 411 is pulled, and the locking element 413 passes through the engaging element 412 to be fastened and fixed, so that the fastening and ligation of the left atrial appendage are completed. The excess suture 411 is separated by the break point, the suture 411 and the suction port 11 are sequentially withdrawn into the delivery catheter 50, and then the delivery catheter 50 is removed from the human body, completing the occlusion process of the left atrial appendage.
In another preferred embodiment, as shown in fig. 6, a cutting device 51 is provided within the delivery catheter 50 for severing the suture 411. The break point part of the suture 411 is prevented from being broken carelessly during fastening, and the suture is safer.
Specifically, after the left atrial appendage 20 is tightly ligated by the elastic collar 41, the suture 411 is pulled at the cutting device 51, and the cutting device 51 cuts the excess suture 411.
Example 2
Unlike embodiment 1, as shown in fig. 10, a second guide 62 is also provided in this embodiment, connected to the support filter 60, for releasing and recovering the support filter 60. The second guide 62 is fitted in the first guide 35, and is capable of controlling the axial movement of the support frame 30 and the support filter 60, respectively.
As shown in fig. 11, when entering the left atrial appendage 20, the distance between the support frame 30 and the support filter 60 is increased, and in the process of aspiration, the thrombus in the left atrial appendage 20 is aspirated into the support filter, and because the distance between the support frame 30 and the support filter 60 is large, whether the thrombus falls into the support filter 60 thoroughly is easier to observe, so that the thrombus is prevented from falling onto the support frame 30 and being unable to be captured.
As shown in FIG. 12, the reduced spacing between the support stent 30 and the support filter 60 after thrombus capture facilitates aspiration of the left atrial appendage 20, allowing the distal end of the left atrial appendage 20 to more invaginate into the left atrium.
As shown in fig. 13, after the aspiration is completed, the first guide 35 controls the support frame 30 to retract, and then the first guide 35 and the second guide control the support frame 30 and the support filter 60 to retract together, respectively, because the thrombus has fallen into the bottom of the support filter, and simultaneously because the support frame 30 retracts to form a mutual clamping effect with the support filter 60, the effect of thrombus is better when retracting, the thrombus can be effectively prevented from accidentally falling off into the left atrium, the distance between the support frame 30 and the support filter 60 can be adjusted according to the shape of the left auricle 20, the operation is more flexible, the using effect is better, and the use safety of the device is improved.
The invention has the following advantages:
(1) The support frame is matched with the suction device to enable the left auricle to be partially sunken, the support frame has excellent shape self-adaptation, and can generate self-adaptation change according to the specific anatomical shape of the specific inner side wall of the left auricle at the release position, so that the support frame fully contacts the inner wall of the distal end of the left auricle, and the support frame is suitable for the left auricle with shallow opening or multi-leaf anatomical shape, thereby ensuring that the inner wall of the left auricle orderly collapses and enters the left atrium according to a preset mode in the process of applying suction pressure.
(2) The fastener adopts ligation type fastening to effectively prevent the fastener from falling off, and the fastening effect is good, and the left auricle of different shapes can be used, and the application scope is wide.
(3) The support frame is also provided with a support filter, so that thrombus trapped in the support frame is captured by the support filter in the process of withdrawing the support frame, and the effectiveness and safety of left auricle plugging are improved.
(4) Through the axial displacement of first guide piece and second guide piece control support frame and support filter respectively, when getting into left auricle, support frame and support filter interval increase, the interval reduces when retrieving support frame and support filter, is favorable to the thrombus of guide capture to get into the bottom of support filter, captures the effect better, and the safety in utilization of device obtains promoting.
The embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present invention and the scope of the claims, which are to be protected by the present invention.
Claims (14)
1. A left atrial appendage occlusion device comprising:
A delivery catheter for introduction into a human body through a blood vessel;
The suction catheter is arranged in the delivery catheter, one end of the suction catheter is connected with a suction port, and the suction port can be attached to the left atrial wall to form an airtight channel;
The suction port is provided with a fastener at one end far away from the suction catheter, and the fastener is used for ligating the left atrial appendage;
The suction catheter is internally provided with a releasable and retractable supporting frame which is used for supporting the left auricle, the supporting frame has shape self-adaption and can generate self-adaption change according to the specific anatomical shape of the inner side wall of the left auricle at a release position, so that the inner wall of the left auricle is sunken according to the outline of the supporting frame and orderly collapses into the left atrium according to a preset manner, and the preset collapse manner of the left auricle comprises that tissues close to the opening of the left auricle preferentially collapse into the left atrium;
The support filter is sleeved at the proximal end of the support frame, and the distance between the support frame and the support filter can be adjusted according to the shape of the left auricle; the support filter is a net-shaped support which can collapse radially, is used for supporting the inner wall of the left auricle and can capture thrombus;
The support frame and the support filter can move along the axial direction respectively, and the support frame and the support filter can be withdrawn into the delivery catheter after the left atrial appendage is depressed.
2. The left atrial appendage occlusion device of claim 1, wherein the scaffold changes from a gathered state to a deployed state upon release from the suction catheter, and wherein the scaffold is capable of undergoing an adaptive deformation upon supporting the left atrial appendage, and wherein the scaffold after deployment is capable of conforming to an inner sidewall of the left atrial appendage.
3. The left atrial appendage occlusion device of claim 1, wherein the support frame comprises a central shaft and a plurality of connecting rods, the connecting rods divergently extending radially outward from the central shaft.
4. The left atrial appendage occlusion device of claim 3, wherein said connecting rod comprises a first strut, a second strut and a third strut, said first strut being connected to said central shaft, said second strut being connected to said first strut, said third strut being connected to said second strut, two of said first struts and two of said second struts forming a quadrilateral, said third strut being curved at an end remote from said central shaft.
5. The left atrial appendage occlusion device of claim 1, wherein the support filter comprises a plurality of flexible rods extending radially outward and circumscribing the support filter, the support filter having a through hole in a bottom thereof, the support filter having a first membrane thereon.
6. The left atrial appendage occlusion device of claim 1, wherein a first guide member is disposed within the aspiration catheter and coupled to the support frame for release and retrieval, and a second guide member is disposed within the first guide member and coupled to the support filter for release and retrieval.
7. The left atrial appendage occlusion device of claim 1, wherein the suction port is a mesh structure having a second membrane disposed about its periphery and radially collapsible within the delivery catheter.
8. The left atrial appendage occlusion device of claim 7, wherein an end of the aspiration port remote from the delivery catheter is flared.
9. The left atrial appendage occlusion device of any one of claims 1-8, wherein the fastener comprises an elastic collar and a retaining element, the elastic collar being releasably disposed over the suction port by the retaining element.
10. The left atrial appendage occlusion device of claim 9, wherein the elastic loop comprises a suture, an engagement element disposed at one end of the suture, and a plurality of locking elements disposed uniformly distributed on the suture, each locking element configured to pass through the engagement element and to be snap-fitted.
11. The left atrial appendage occlusion device of claim 10, wherein the engagement element is a ring or sleeve.
12. The left atrial appendage occlusion device of claim 10, wherein the locking element comprises a first end and a second end, the first end having a smaller dimension than the second end, the first end and the second end being capable of passing through the engagement element in sequence.
13. The left atrial appendage occlusion device of claim 10, wherein the suture is provided with a break for separating the suture portions after the fastener ligates the left atrial appendage.
14. The left atrial appendage occlusion device of claim 9, wherein a cutting device is disposed within the delivery catheter.
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| CN114027913B (en) * | 2021-12-07 | 2024-04-19 | 云南省阜外心血管病医院 | Left auricle and heart external cerclage system for adsorption type cardiac surgery |
| EP4356847A1 (en) * | 2022-10-17 | 2024-04-24 | Biotronik Ag | Endovascular catheter system for inversion of the laa, particularly for resection of the laa |
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| CN106163422A (en) * | 2013-12-30 | 2016-11-23 | 阿特瑞克尔公司 | System and method for left atrial appendage occlusion |
| CN106473791A (en) * | 2016-09-22 | 2017-03-08 | 杭州诺茂医疗科技有限公司 | A kind of occluder for left auricle of adjustable distance |
| CN109381238A (en) * | 2017-08-07 | 2019-02-26 | 杭州诺茂医疗科技有限公司 | A kind of occluder for left auricle |
| WO2021001830A1 (en) * | 2019-07-02 | 2021-01-07 | Append Medical Ltd. | Left atrial appendage manipulation |
| CN215306341U (en) * | 2021-04-25 | 2021-12-28 | 上海纽脉医疗科技有限公司 | Left auricle plugging device |
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| WO2006110734A2 (en) * | 2005-04-07 | 2006-10-19 | Sentreheart, Inc. | Apparatus and method for the ligation of tissue |
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| CN106163422A (en) * | 2013-12-30 | 2016-11-23 | 阿特瑞克尔公司 | System and method for left atrial appendage occlusion |
| CN106473791A (en) * | 2016-09-22 | 2017-03-08 | 杭州诺茂医疗科技有限公司 | A kind of occluder for left auricle of adjustable distance |
| CN109381238A (en) * | 2017-08-07 | 2019-02-26 | 杭州诺茂医疗科技有限公司 | A kind of occluder for left auricle |
| WO2021001830A1 (en) * | 2019-07-02 | 2021-01-07 | Append Medical Ltd. | Left atrial appendage manipulation |
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