CN111839644A - Device of self-adaptation cavity - Google Patents

Device of self-adaptation cavity Download PDF

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Publication number
CN111839644A
CN111839644A CN202010725676.2A CN202010725676A CN111839644A CN 111839644 A CN111839644 A CN 111839644A CN 202010725676 A CN202010725676 A CN 202010725676A CN 111839644 A CN111839644 A CN 111839644A
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adaptive
anchoring
self
support
spring
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李彪
张丽红
邵烨
李刚
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Ningbo Diochange Medical Technology Co Ltd
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Ningbo Diochange Medical Technology Co Ltd
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Priority to CN202010725676.2A priority Critical patent/CN111839644A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12031Type of occlusion complete occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Prostheses (AREA)

Abstract

The invention provides a device for a self-adaptive cavity, which comprises a central end part and an anchoring support, wherein the anchoring support is formed by a plurality of elastic supporting rods which are diverged from the central end part, a self-adaptive structure is arranged in a local or whole area of the supporting rods of the anchoring support, and when the anchoring support is extruded by the inner wall of the cavity, the self-adaptive structure immediately makes a bending deformation reaction so that the anchoring support is attached to the inner wall of the cavity in a self-adaptive manner. The device provided by the invention can be self-adapted to left atrial appendages of various different forms, has wider adaptability and greatly reduces the incidence rate of postoperative complications in the operation.

Description

Device of self-adaptation cavity
Technical Field
The invention relates to the field of medical instruments, in particular to a cavity self-adaptive device.
Background
Atrial fibrillation (hereinafter referred to as "atrial fibrillation") is the most common tachyarrhythmia. The atrial effective contraction is lost during atrial fibrillation, blood is caused to be retained in the left atrial appendage, in addition, the unique anatomical structure of the left atrial appendage and the unevenness of the inner musculature make the retained blood generate vortex, the formation of thrombus is promoted, the thrombus falls off from the left atrial appendage and enters the arterial system, pulmonary embolism, cerebral infarction, myocardial infarction and the like can be caused, the most serious result of the falling thrombus is cerebral obstruction, and the thrombus is retained in blood vessels of the brain to limit the blood flow and cause stroke. Once stroke occurs, it is disabled if mild and killed if severe.
The current preventive strategies for patients with high risk atrial fibrillation mainly include anticoagulation therapy, surgical left atrial appendage ligation and left atrial appendage occlusion, and the application of left atrial appendage occlusion to reduce embolic events due to atrial fibrillation is becoming the hot spot of current research. The left atrial appendage occlusion is different from other treatment schemes, and is an innovative operation for preventing stroke of patients with non-valvular atrial fibrillation. It prevents embolism caused by thrombus drop of the left auricle by plugging the left auricle, thereby avoiding cerebral arterial thrombosis and systemic embolism. The left atrial appendage occlusion can reduce the risk and trauma brought by surgical operation, can eliminate the dependence of patients on long-term anticoagulation treatment, avoids the problems of intolerance, bleeding incidents, compliance and the like of the patients caused by anticoagulation medicaments, and brings new hopes to the patients with contraindications to the anticoagulation medicaments.
The key equipment of left atrial appendage occlusion is an occluder. The anchoring frame of the plugging device in the market at present has various structures, but according to the product form, the anchoring frame has the following two types: the first is that the far ends of a plurality of rods which form the anchoring frame are in a free open state, the anchoring frame forms an umbrella-shaped or bowl-shaped structure, and is represented by a lamb product (patent number: CN201480073126.X) and a WATCHMAN product (patent number: CN 201280054920.0); the second is a cage-like structure formed by the distal ends of the closed and fixed connections, as represented by the Haipao LACbes product (patent number: CN201610565731. X).
The disadvantages of the first occluder anchor frame are:
1. the distal end is in an open state, the distal end of the rod can contact the inner wall of the conveying sheath, and the distal end of the rod is relatively sharp, so that the risks of scraping the sheath and possibly releasing the sheath from the sheath tube are easily caused, and therefore, the operation mode of installing and releasing the conventional occluder cannot be adopted (after the occluder is arranged in the short sheath, the short sheath is connected with the long sheath, then the occluder is pushed into the long sheath, and then the occluder is released), and the structure needs the occluder to be preinstalled in the long sheath, so that the diameter of the required conveying sheath is larger, and the range of adaptation diseases is limited;
2. the currently adopted measures are that a ball head is formed at the far end, but the defects that the resistance released from a sheath tube is large and the hand feeling experience of an operator is poor still exist, and the problems of poor corrosion resistance and the like exist when the ball head is connected with the far end of a rod in a welding mode and the like;
3. more importantly, the far end is in an open state, the far end of the rod is relatively sharp, the rod is particularly rigid, the inner wall of the left auricle is particularly thin, and even if the far end of the rod adopts a measure of a ball head, the left auricle can still be punctured in the process that an operator pushes the occluder out of the sheath tube and releases the occluder to a target position;
4. the far end of the rod is open and is not restrained at all, the anchoring frame has different shapes in the left auricle, and the anchoring effect is difficult to ensure effectively.
The disadvantages of the second occluder anchor frame are:
1. the distal end is in a closed state, and for manufacturers, the manufacturing process of closed connection is complicated, including the sleeve and the fixed connection process which need additional design, and the manufacturing cost is increased; the current commonly used fixed connection process is welding, the connection failure fault occurs frequently, and the phenomena of anchor frame wire falling or frame scattering often occur clinically;
2. the sheath diameter of the sheath compressed to enter the conveying sheath is larger due to the need of additionally designing connecting structures such as a sleeve and the like, so that the application range is limited;
3. more importantly, the distal rod is particularly rigid, and the inner wall of the left atrial appendage is particularly thin, so that even if the closed distal end (and the cannula) adopts measures such as a ball head and the like, the inner wall of the left atrial appendage can still be punctured in the process that an operator pushes the occluder out of a sheath tube and releases the occluder to a target position, and risks such as pericardial tamponade, perforation, pericardial effusion and the like are caused;
4. the anchoring frame is of a closed grid-shaped structure, and the radial supporting force is large, so that the adaptability of the anatomical form of the anchoring frame in the left auricle is poor, the form of the left auricle is easily over-corrected, and the waist of the anchoring frame easily causes local stimulation and inflammatory reaction to the contact area of the left auricle;
5. the anchoring frame can cause stress concentration and fatigue at the fixed connection point of the left auricle along with the beating of the heart, and because the rod of the anchoring frame adopts a rigid and hard structural design, the rod of the anchoring frame, particularly the far end of the anchoring frame can abrade the inner cavity tissue of the left auricle and even puncture the inner wall of the left auricle, so that the risks of pericardial stuffing, perforation, pericardial effusion and the like are caused;
6. the anchoring frame is a closed cage-like structure, the rod of the anchoring frame is of a rigid and stiff structural design, so that the position of the distal anchorage point is relatively constant with respect to the proximal end of the anchoring frame, while in the anatomical configuration of the left atrial appendage about 80% of the left atrial appendage is a bilobed or multilobal left atrial appendage, i.e. the left atrial appendage is of varying depth, and when the distance between the opening of the left atrial appendage and the ridge of the lobular inner leaflet of the left atrial appendage (i.e. the depth of the anchoring zone) is too small, especially at a height less than the waist of the anchoring frame, the anchoring frame is difficult to be inserted completely into the left atrial appendage, and thus this situation is not suitable for placing such an occluder.
In summary, there is an urgent need to design a device with a self-adaptive cavity, which facilitates the safe and smooth release during the operation and can self-adapt to various anatomical forms of the left auricle.
Disclosure of Invention
The invention aims to provide a cavity self-adaptive device to solve the problem that an anchoring device of an occluder in the prior art cannot adapt to various anatomical shapes of a left auricle.
In order to achieve the technical purpose, the invention adopts the following technical means:
the utility model provides a device of self-adaptation cavity, includes central tip and anchoring support, anchoring support by many that central tip was dispersed out have elastic bracing piece and enclose, anchoring support the local or whole region of bracing piece is provided with adaptive structure, works as anchoring support receives the cavity inner wall extrusion, adaptive structure makes the bending deformation reaction immediately, makes anchoring support adaptability laminate in cavity inner wall.
Preferably, the anchor support extends inwards from the central end part towards the far end to form a first bending part, extends outwards from one end of the first bending part far away from the central end part towards the near end to form a second bending part, and extends from one end of the second bending part far away from the first bending part towards the far end to form a transition part; the support rods are circumferentially and rotationally symmetrical along the central axis of the central end part to form the bowl-shaped anchoring support; in the transition part, a plurality of support rods are connected end to form a corrugated structure; an anchoring structure is arranged on the anchoring support.
Preferably, the device further comprises a collecting part which extends from the far end of the anchoring bracket along the direction close to the central axis of the central end part and collects at a collecting point, so that the device forms a cage shape, and the collecting part is provided with a self-adaptive structure.
Preferably, the flexural modulus of the adaptive structure is not more than 1/10 of the flexural modulus of the non-adaptive structure.
Preferably, the self-adaptive structure is a three-dimensional spiral structure, the three-dimensional spiral structure is a spring, the wire diameter of the spring is 0.05-0.2mm, and the overall diameter of the spring is 0.2-1 mm; or the self-adaptive structure is a two-dimensional S-shaped structure, and the solid rod width of the two-dimensional S-shaped structure is less than or equal to 1/2 of the whole width; or the adaptive structure is a linear structure, and the minimum cross-sectional area in the linear structure is not more than 1/2 of the cross-sectional area of the non-adaptive structure.
Preferably, the adaptive structure of the collecting part is a three-dimensional spiral structure, and the three-dimensional spiral structure is a spring; the supporting rods correspond to the springs in number and position one by one, the supporting rods are connected with one ends of the springs, and the other ends of the springs are converged to form a convergence point; or the quantity of bracing piece is the even number, the quantity of spring does the quantity of bracing piece is half, many the bracing piece is connected with many the both ends of spring, many the spring alternates each other in the middle zone of every spring and twines the realization and connect to form the collection point.
Preferably, the adaptive structure of the pooling portion is a two-dimensional S-shaped structure.
Preferably, a transitional connecting structure is arranged on the supporting rod, and part of the spring is wound on the transitional connecting structure, so that the transitional connecting structure and the spring form a buffer connecting area; or the supporting rod is provided with a reinforced connecting structure, and the spring forms limiting connection or fixed connection at the reinforced connecting structure.
Preferably, after one end of the adaptive structure is connected with the support rod, the adaptive structure extends out of the anchoring support to form an anchoring structure.
Preferably, the anchoring stent further comprises a first flow-resisting film, wherein the first flow-resisting film is composed of a plurality of coating films, and the support rod of the anchoring stent is coated by the plurality of coating films; the anchoring support is provided with a film connecting structure, the film connecting structure comprises at least one coil and/or limiting structure, and the coated film is fixedly connected with the anchoring support through the mutual matching of the coil and the limiting structure.
By adopting the technical scheme, compared with the prior art, the invention has the following technical effects:
(1) different from the existing occluder with a cage-shaped or bowl-shaped anchoring frame, the self-adaptive cavity device provided by the invention has excellent pressure transmission performance due to the self-adaptive structure when being subjected to certain pressure, so that the device has good introduction performance in the process of pushing from the near end to the far end in a sheath tube, is convenient to smoothly reach target positions such as left auricle and the like, and avoids the problems that the inner wall of the sheath is possibly scraped and the like in the introduction process of the traditional occluder in the sheath tube.
(2) The three-dimensional helical structure, being an adaptive structure, has very strong bending compliance characteristics, so that the collection portion as a whole can behave as a soft wire, just as the device is pushed from the sheath to the target site, with the collection point of the collection portion first pushed out of the sheath and being ellipsoid or spherical, as shown in fig. 2a, which shape makes the distal portion of the anchoring frame, including the collection portion, never damage the cavity tissue, both during unsheathing and during the complete push out of the device from the sheath until release to the target site so that the transition portion fits against the inner wall of the left atrial appendage, and therefore there is no risk of puncturing the inner wall of the left atrial appendage at all, which in turn reduces the psychological stress on the operator to release the device during surgery.
(3) The three-dimensional spiral structure has good elasticity when being subjected to the force within the allowable pulling force range, namely, the total length of the three-dimensional spiral structure can obtain a certain length of extension within a certain range, and when the distance between the opening of the left auricle and the ridge of the left auricle inner leaflet (namely the depth of the anchoring area) is too small, especially when the distance is less than the height of the waist of the device, the device can still be completely inserted into the left auricle as shown in figure 2b, so that the problems of reducing the anchoring effectiveness and the like caused by too shallow position of the device placed in the left auricle are solved, therefore, the collection part can adapt to the multi-leaf left auricle anatomical structure, and the three-dimensional spiral structure has a wide adaptation range and can almost cover all patient groups.
(4) The whole cross section area of the three-dimensional spiral structure is much larger than that of the support rod of the conventional occluder, so that the three-dimensional spiral occluder has an excellent developing effect in the operation, an operator can observe and recognize the three-dimensional spiral structure in time in the operation, the safety and the smoothness of the operation process are ensured, and the follow-up tracking of a patient after the operation is also facilitated.
(5) The three-dimensional spiral structure and the linear structure serving as the self-adaptive structure have very strong bending compliance characteristics, so that after the device is placed in biological cavities such as the left auricle and the like, the radial supporting force provided by the device is weakened to a certain extent, the device can be compressed randomly on the whole, and adaptive change can be performed along with the shape of the left auricle cavity, so that the contradiction that the radial supporting force of the traditional cage-shaped occluder cannot be adjusted with various left auricle anatomical structures is avoided, and the device can better adapt to the self internal shape of the left auricle on the basis of ensuring certain anchoring force.
(6) From the manufacturing mode, when the self-adaptive structure of the gathering part adopts the springs, the far-end gathering point does not need to be welded, only a plurality of springs need to be simply inserted and overlapped to complete the process, the process of inserting and overlapping the wires is firm in connection, the occurrence of wire falling is avoided, and the fatal problems of fatigue fracture, poor corrosion resistance and the like caused by the fact that the traditional cage-shaped plugging device needs to adopt the processes of welding and the like are further avoided.
(7) The two-dimensional S-shaped structure or linear structure as the self-adaptive structure ensures that the device has certain radial supporting force, the radial supporting force cannot excessively prop open the cavity of the left auricle, the shape of the left auricle cannot be excessively corrected, and the anchoring force of the device is further improved; in addition, the two-dimensional S-shaped structural design is convenient for adding a coil to be shaped on the first flow-resisting film, a limiting structure is not required to be additionally arranged, and the first flow-resisting film is fixed on the device and cannot slide or fall off randomly.
Drawings
Fig. 1a is a schematic structural diagram of an apparatus for adaptive cavity in embodiment 1 of the present invention;
FIG. 1b is an enlarged view of a portion I of FIG. 1 a;
FIG. 1c is a top view of an apparatus with an adaptive cavity according to embodiment 1 of the present invention;
fig. 1d is an enlarged view of a partial view ii in fig. 1c when a transition connection structure is provided on the support bar in embodiment 1 of the present invention;
fig. 1e is an enlarged view of a partial view ii in fig. 1c when the supporting rod is provided with a reinforcing connection structure in embodiment 1 of the present invention;
FIG. 1f is a schematic view of the manner in which the springs form a collection point in example 1 of the present invention;
FIG. 2a is a schematic diagram of the self-adaptive cavity device of the present invention in a release process in the left atrial appendage;
FIG. 2b is a schematic representation of the self-adaptive chamber device of the present invention in a released configuration in the left atrial appendage;
FIG. 3a is a schematic structural diagram of another embodiment of example 1 of the present invention;
FIG. 3b is an enlarged view of a portion III of FIG. 3 a;
fig. 4a is a schematic structural diagram of an apparatus for adaptive cavity in embodiment 2 of the present invention;
FIG. 4b is a schematic structural view of a membrane connection structure in example 2 of the present invention;
fig. 5a is a schematic structural diagram of an apparatus for adaptive cavity in embodiment 3 of the present invention;
FIG. 5b is an enlarged view of the detail view IV of FIG. 5 a;
FIG. 5c is a top view of an apparatus with an adaptive cavity according to embodiment 3 of the present invention;
fig. 5d is a schematic diagram of the two-dimensional S-shaped structure in embodiment 3 of the present invention functioning as a limiting structure in the membrane connection structure;
fig. 6a is a schematic structural diagram of an apparatus for adaptive cavity in embodiment 4 of the present invention;
FIG. 6b is a top view of an apparatus with adaptive cavity in embodiment 4 of the present invention;
FIG. 7 is a schematic structural diagram of another embodiment of example 4 of the present invention;
fig. 8a is a schematic structural diagram of an apparatus for adaptive cavity in embodiment 5 of the present invention;
FIG. 8b is a top view of an apparatus with adaptive cavity in embodiment 5 of the present invention;
FIG. 8c is an enlarged view of the detail view V of FIG. 8 b;
FIG. 8d is an enlarged view of detail VI of FIG. 8 b;
fig. 9a is a schematic structural diagram of an apparatus for adaptive cavity in embodiment 6 of the present invention;
FIG. 9b is a top view of an apparatus with adaptive cavity in embodiment 6 of the present invention;
FIG. 9c is an enlarged view of the detail view VII of FIG. 9 b;
FIG. 9d is an enlarged view of section VIII of FIG. 9 b;
FIG. 10a is a schematic structural diagram of an apparatus with an adaptive cavity according to embodiment 7 of the present invention;
FIG. 10b is a top view of an apparatus with adaptive cavity in example 7 of the present invention;
fig. 11 is a schematic structural diagram of an apparatus for adaptive cavity in embodiment 8 of the present invention;
the symbols in the drawings indicate the description:
10-anchoring stent, 11-first bend, 12-second bend, 13-transition, 14-anchoring structure, 141-J type hook, 142-fold line type barb, 15-coil, 16-limiting structure, 20-central end, 30-convergence part, 40-first flow-blocking membrane, 50-second flow-blocking membrane, 60-blocking disk.
Detailed Description
In this document, "proximal" and "distal" are relative orientations, relative positions, and directions of elements or actions with respect to each other from the perspective of an operator using the medical device, although "proximal" and "distal" are not intended to be limiting, but "proximal" generally refers to the end of the medical device that is closer to the surgeon during normal operation, and "distal" generally refers to the end that is further from the surgeon during surgery.
The self-adaptive structure has excellent pressure transmission performance, can endow the device with good introduction performance in the process of pushing from the near end to the far end in the sheath tube, is convenient for smoothly reaching a biological cavity, such as target positions of a left auricle and the like, and can also avoid the occurrence of the problems of scraping the inner wall of the sheath and the like which are possibly caused in the introduction process of the traditional occluder in the sheath tube.
Therefore, the present invention provides a device for adapting to a cavity, as shown in fig. 1a-1c, which includes a central end portion and an anchoring support, wherein the anchoring support is surrounded by a plurality of elastic supporting rods diverged from the central end portion, and a local or whole area of the supporting rods of the anchoring support is provided with an adaptive structure, and when the anchoring support is squeezed by the inner wall of the cavity, the adaptive structure immediately makes a bending deformation reaction, so that the anchoring support is adaptively attached to the inner wall of the cavity.
In one embodiment, as shown in FIG. 1a, the anchor stent extends from the central end portion to the distal end to form a first curved portion, extends from the end of the first curved portion away from the central end portion to the proximal end to form a second curved portion, and extends from the end of the second curved portion away from the first curved portion to the distal end to form a transition portion; the plurality of support rods are circumferentially and rotationally symmetrical along the central axis of the central end part to form a bowl-shaped anchoring support; in the transition part, a plurality of support rods are connected end to form a wavy structure; the anchoring support is provided with an anchoring structure.
Furthermore, as shown in fig. 1a, the device further comprises a collecting part which extends from the far end of the anchoring bracket along the direction of the central axis close to the central end part and collects at a collecting point, so that the device forms a cage shape, and the self-adaptive structure is arranged at the collecting part.
For the adaptive structure described above, in one particular embodiment, the flexural modulus of the adaptive structure is no more than 1/10 the flexural modulus of the non-adaptive structure. Furthermore, the self-adaptive structure is a three-dimensional spiral structure, the three-dimensional spiral structure is a spring, the wire diameter of the spring is 0.05-0.2mm, and the overall diameter of the spring is 0.2-1 mm; or the adaptive structure is a two-dimensional S-shaped structure, as shown in FIG. 5d, the width of the solid rod of the two-dimensional S-shaped structure is less than or equal to 1/2 of the whole width; or the adaptive structure is a linear structure, as in FIG. 1b, and the minimum cross-sectional area in the linear structure is ≦ 1/2 for the cross-sectional area of the non-adaptive structure. In a preferred embodiment, the spring is made of a medical implant-grade metal material, such as nitinol, tantalum, 316L, or the like.
The two-dimensional S-shaped structure or linear structure as the self-adaptive structure ensures that the device has certain radial supporting force, the radial supporting force cannot excessively prop open the cavity of the left auricle, the shape of the left auricle cannot be excessively corrected, and the anchoring force of the device is further improved; in addition, the two-dimensional S-shaped structural design is convenient for adding a coil to be shaped on the first flow-resisting film, a limiting structure is not required to be additionally arranged, and the flow-resisting film is fixed on the device and cannot slide or fall off randomly.
The three-dimensional spiral structure and the linear structure serving as the self-adaptive structure have very strong bending compliance characteristics, so that after the device is placed in biological cavities such as the left auricle and the like, the radial supporting force provided by the device is weakened to a certain extent, the device can be compressed randomly on the whole, and adaptive change can be performed along with the shape of the left auricle cavity, so that the contradiction that the radial supporting force of the traditional cage-shaped occluder cannot be adjusted with various left auricle anatomical structures is avoided, and the device can better adapt to the self internal shape of the left auricle on the basis of ensuring certain anchoring force.
When the adaptive structure of the gathering part adopts a three-dimensional spiral structure, the gathering part can be wholly expressed as soft like a silk thread, at the moment when the device is just pushed to a target position from the sheath, the gathering point of the gathering part is firstly pushed out of the sheath, and is in an ellipsoid shape or a spherical shape, as shown in fig. 2a, the shape ensures that the distal part of the anchoring frame, including the gathering part, can not damage the cavity tissue all the time in the process of taking out the sheath and the whole process from complete pushing out of the sheath to releasing to the target position so that the transition part is attached to the inner wall of the left auricle, therefore, the risk of puncturing the inner wall of the left auricle can not occur at all, and the psychological pressure of an operator releasing the device in the operation is reduced.
In addition, the three-dimensional spiral structure will have good elasticity when subjected to a force within an allowable pulling force range, in other words, the total length of the three-dimensional spiral structure can be extended to a certain length within a certain range, and when the distance between the opening of the left atrial appendage and the ridge of the inner leaflet of the left atrial appendage (i.e. the depth of the anchoring zone) is too small, especially smaller than the height of the waist of the device, the device can still be completely inserted into the left atrial appendage, as shown in fig. 2b, so as not to cause the problem that the position of the device placed in the left atrial appendage is too shallow, which reduces the anchoring effectiveness, and the like, therefore, the collecting part can adapt to the anatomy structure of the multi-lobal left atrial appendage, and further has a wide adaptation range, and can almost cover the whole patient population.
In addition to the above, in a specific embodiment of the present invention, as shown in fig. 1a, the adaptive structure of the collecting part is a three-dimensional spiral structure, and the three-dimensional spiral structure is a spring; as shown in fig. 5c, the supporting rods correspond to the springs in number and position one by one, the supporting rods are connected with one ends of the springs, and the other ends of the springs are collected to form a collection point; or the number of the supporting rods is even, as shown in fig. 1c, the number of the springs is half of the number of the supporting rods, the supporting rods are connected with two ends of the springs, and the springs are mutually inserted and wound in the middle area of each spring to realize connection and form a gathering point; further, as shown in fig. 1f, a straight line segment with a certain length is arranged in the middle area of the spring, so that each spring is wound and connected with each other at the position, and a collection point of a collection part is formed, which is convenient for manufacturers to wind, connect and manufacture more conveniently and more firmly; furthermore, the present invention can be applied to the clinical personalized requirements, for example, the difference of the anatomical structures of the left auricle of different patients is large, the shape holding ability of the gathering portion in some regions is required to be strong, and the shape holding ability of some regions, for example, the vicinity of the gathering point, is weak and can be slightly deformed, so that the spring can be set to be a reducing spring with a small diameter in the area of the gathering point and a large diameter in the peripheral area of the gathering portion. Furthermore, in some embodiments, the manner of collection of the springs further includes glue joining, mechanical clamping, laser welding, and the like.
In a preferred embodiment, each three-dimensional spiral structure of the collecting section emerges from its central point and diverges radially or spirally with respect to the central axis of the central end; wherein, when three-dimensional spiral structure is the spiral and diverges the form, as in fig. 5c, have more outstanding crooked compliance and tensile elasticity, just because the spring has more outstanding crooked compliance characteristic, make the support place back in biological cavity such as left auricle, the radial holding power that the support provided further weakens, anchor frame shows as compressing at will on the whole, and can make more outstanding adaptability change along with the form of left auricle cavity, consequently, the irreconcilable contradiction of traditional cage form occluder radial holding power and multiple left auricle anatomy structure has been avoided, on the basis of guaranteeing certain anchoring power, the device can adapt to the self internal form of left auricle better.
In a specific embodiment, a transitional connection structure is provided on the support rod, and a part of the spring is wound on the transitional connection structure, so that the transitional connection structure and the spring form a buffer connection area, for example, a snap structure, as shown in fig. 1 d; or a reinforced connecting structure is arranged on the supporting rod, and the spring forms a limiting connection or a fixed connection at the reinforced connecting structure, such as one or more connecting holes, as shown in fig. 1 e; in addition, in some embodiments, the fixing connection of the support rod and the spring further includes glue connection, mechanical clamping, laser welding, and the like.
In a specific embodiment, after one end of the adaptive structure is connected with the support rod, the adaptive structure extends out of the anchoring support and forms an anchoring structure, as shown in fig. 6a-6b, the anchoring structure is a J-shaped hook, and compared with a J-shaped hook manufactured by cutting, the J-shaped hook manufactured by the tail end wire of the spring has certain stress buffering and does not generate fatigue fracture.
In a specific embodiment, the anchoring structure is disposed on the anchoring support to enhance the anchoring effectiveness of the anchoring support in the left atrial appendage cavity, so as not to fall off, and as shown in fig. 5a, the anchoring structure may be a fold-line type barb disposed at the intersection of the first bending portion and the second bending portion, or as shown in fig. 1a, the anchoring structure may be a J-shaped hook disposed on the transition section. Further, the free end of the barb or hook is passivated, such as with a ball head, a hemispherical head, an oval head, etc. The J-shaped hook has the advantages that: the J-shaped hook can improve the anchoring force, and the J-shaped hook after passivation treatment can hook on the comb-shaped muscle in the release process to further improve the anchoring force, so that the inner wall tissue of the left auricle cannot be abraded along with the beating of the heart after the occluder is implanted, and the left auricle cannot be damaged or pierced. Further, in some embodiments, the anchor stent has one or more rows of anchor structures disposed thereon, the anchor structures having one or more of a dogleg shape, a hook shape, a J-shape, a flat shape, and a curved shape.
In a preferred embodiment, the self-adaptive cavity device further comprises a first flow-blocking film, wherein the first flow-blocking film is composed of a plurality of covering films, and the plurality of covering films cover the support rods on the anchoring support, as shown in fig. 4 a. The flow-resistant film has the advantages that: effective plugging can be achieved without the need for additional plugging disks. Specifically, the material of the coating film is polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane, polyamide, silica gel, polyolefin, or degradable materials such as polylactic acid, polyvinyl alcohol, or the like, or the coating film is selected from animal tissues.
Furthermore, the anchoring support is provided with a membrane connecting structure, the membrane connecting structure comprises one or more coils and a limiting structure, and as shown in fig. 4b, the coils and the limiting structure are mutually matched to connect the coating film on the anchoring support, so that the first flow blocking membrane of the device does not fall off or is not damaged in the process of entering and exiting the sheath. In addition, in some embodiments, the anchoring stent is connected with the covering film by hot-pressing, suture fixation, and the like. Further preferably, the anchoring stent and the coating film are connected in a hot-pressing covering mode, the fixing is firmer than that of a traditional suture, and the first flow blocking film is not easy to fall off and is not easy to damage when the device enters and exits the conveying sheath due to no seam holes.
In a particular embodiment, the central end portion is provided with a detachable connection structure for facilitating connection with a transmission cable.
In a specific embodiment, the device further comprises a blocking disc connected to the central end portion, the proximal end of the blocking disc being provided with a detachable connection structure facilitating connection to the delivery cable.
In order to make the objects, features and advantages of the present invention more apparent, the following detailed description is made with reference to fig. 1a to 11 and the embodiments. It should be understood that the embodiments described herein are intended to be illustrative in simplified form and not to be construed as limiting the invention.
Example 1
As shown in fig. 1a-1 f, the present embodiment provides a self-adaptive cavity device, which includes a central end portion 20 and an anchoring support 10, wherein the anchoring support 10 is surrounded by a plurality of elastic support rods diverged from the central end portion 20. As shown in fig. 1a and 1c, the support rod extends from the central portion 20 to the inner recess to form a first curved portion 11, extends from the end of the first curved portion 11 far away from the central portion 20 to the outer recess to form a second curved portion 12, and extends from the end of the second curved portion 12 far away from the first curved portion 11 to the distal direction to form a transition portion 13; the plurality of support rods are circumferentially and rotationally symmetrical along the central axis of the central end portion 20 to form a bowl-shaped anchoring support 10; in the transition part 13, a plurality of support rods are connected end to form a wave-shaped structure; the transition part 13 is provided with an anchoring structure, the first bending part 11 and/or the second bending part 12 are/is provided with a self-adaptive structure, when the anchoring support 10 is extruded by the inner wall of the cavity, the self-adaptive structure immediately makes a bending deformation reaction, so that the transition part 13 of the anchoring support 10 is adaptively attached to the inner wall of the cavity.
In the embodiment, as shown in fig. 1b, the adaptive structure provided by the first bending portion 11 and/or the second bending portion 12 is a linear structure, and the minimum cross-sectional area in the linear structure is less than or equal to 1/2 of the cross-sectional area of the non-adaptive structure, and the flexural modulus of the adaptive structure is not more than 1/10 of the flexural modulus of the non-adaptive structure.
In this embodiment, as shown in fig. 1a and 1c, a collecting portion 30 is further included, which extends from the distal end of the anchor stent 10 in a direction close to the central axis of the central portion 20 and collects at a collecting point, so that the device is formed into a cage shape, and an adaptive structure is arranged at the collecting portion 30, and the flexural modulus of the adaptive structure is not more than 1/10 of the flexural modulus of the non-adaptive structure. As shown in FIG. 1c, the adaptive structure is a three-dimensional spiral structure, the three-dimensional spiral structure is a spring, the wire diameter of the spring is 0.05-0.2mm, and the diameter of the spring is preferably 0.2-1 mm. The spring is made of medical implant-grade metal materials, such as nickel-titanium alloy, tantalum, 316L and the like.
In this embodiment, as shown in fig. 1a and 1c, the number of the support rods at the distal end of the anchoring support 10 is 6, and the number of the springs is 3, as shown in fig. 1f, the 3 springs are mutually inserted and wound in the middle area of each spring to realize connection, and form a collection point, and the 3 springs form a collection portion 30.
In this embodiment, in an implementation, a transition connection structure is arranged on the support rod, and the spring is wound on the transition connection structure, so that the transition connection structure and the spring form a buffer connection area, as shown in fig. 1d, the transition connection structure is a buckle, and two ends of each spring are respectively in limit connection with the buckle on the support rod. In another embodiment, the support rod is provided with a reinforcing connection structure, such as one or more connecting holes in fig. 1e, and for such a perforated connection, one or more connecting holes are provided in the distal region of the anchoring support 10 in advance, so that the two end wires of the spring can pass through the connecting holes.
In another embodiment, which differs from embodiment 1 in that the structure does not have a distal support bar of the anchor stent 10, as shown in fig. 3a and 3b, the two ends of the spring are directly connected to the ends of the transition section 13 of the anchor stent 10, as shown in fig. 3 b.
In this embodiment, the transition portion 13 is provided with an anchoring structure 14 in the form of a J-shaped hook 142.
Example 2
As shown in fig. 4a-4b, the adaptive cavity apparatus provided in this embodiment further includes a first flow-blocking film 40 based on the apparatus provided in embodiment 1, where the first flow-blocking film 40 is composed of a plurality of covering films, and the plurality of covering films cover the supporting rods of the anchor stent 10, as shown in fig. 4 a. The anchoring support 10 is provided with a membrane connecting structure which is one or more coils 15 and a limiting structure 16, as shown in fig. 4b, the coil 15 and the limiting structure 16 are mutually matched to connect the coating film on the anchoring support 10, so that the first current blocking membrane 40 does not fall off or be damaged in the process of entering and exiting the sheath.
In this embodiment, the central end 20 is provided with a detachable connection structure for connecting with a transmission cable.
In this embodiment, the anchoring support 10 and the coating film are connected by hot-pressing.
Example 3
As shown in fig. 5a to 5d, the apparatus with adaptive cavity provided in this embodiment is based on the apparatus provided in embodiment 1, and the first difference between embodiment 3 and embodiment 1 is that: each three-dimensional spiral structure of the convergence part 30, i.e., the springs, emanates from a central point thereof and diverges spirally with respect to the central axis of the central end part 20, rather than radially, as in fig. 5c, and the support rods and the springs correspond one-to-one in number and position, with 6 support rods connected to one end of 6 springs and the other ends of 6 springs converging to form a convergence point.
The second difference is that: the first bending part 11, the second bending part 12 and the transition section 13 of the anchoring stent 10 are provided with an adaptive structure, as shown in fig. 5b, which is a two-dimensional S-shaped structure, the solid rod width of which is less than or equal to 1/2 of the whole width, so that the two-dimensional S-shaped structure realizes three-dimensional bending, and the fold-line type barbs 142 are provided at the intersection of the first bending part 11 and the second bending part 12, and the transition section 13 is free of J-shaped hooks 141, as shown in fig. 5 a.
Example 4
As shown in fig. 6a-6b, the apparatus with adaptive cavity provided in this embodiment is based on the apparatus provided in embodiment 1, and the first difference between embodiment 4 and embodiment 1 is that: the three-dimensional helical structure, i.e. the spring, lengthens and winds all or part of the transition 13 to achieve its fixation to the anchoring support 10.
The second difference is that: the three-dimensional spiral type structure, i.e., the spring, as the adaptive structure, after both ends are connected to the support rod, further extends out of the anchoring bracket 10, and forms the anchoring structure 14, i.e., the J-shaped hook 141.
In another embodiment, the first and second bent portions 11 and 12 of the anchor bracket 10 of the device provided in embodiment 4 are provided with a two-dimensional S-shaped structure, as in fig. 7.
Example 5
The central end portion 20, the anchoring stent 10 (including the first bending portion 11, the second bending portion 12 and the transition section 13) of the self-adaptive lumen device provided in examples 1 to 4 are cut and shaped from a medical metal tube, however, in the present embodiment, as shown in fig. 8a to 8d, only the transition portion 13 of the anchoring stent 10 is cut and shaped from a medical metal tube, the central end portion 20, the first bending portion 11 and the second bending portion 12 are shaped from a three-dimensional spiral type structure (i.e., springs) in the self-adaptive structure, and the springs are wound around the transition portion 13 of the anchoring stent 10.
In this embodiment, one end of the spring of the first bending part 11 constitutes the central end part 20 of the device, the other end is connected with one end of the second bending part 12, and the other end of the second bending part 12 is wound on the wave band on one side of the transition part 13; the connection of the spring of the convergence part 30 and the anchor bracket 10 is the same as that of embodiment 4, both ends of the spring are respectively wound on the wave bands on the other side of the transition part 13, and the tail end wires of both ends of the spring of the convergence part 30 are made into J-shaped hooks 141.
The technical means in the embodiment has the following advantages: the spring has contraction ductility, so that the spring can adapt to a complex left auricle, such as a more developed left auricle with multi-lobe or comb-shaped muscles; the flexibility of the spring is better, and the inner wall of the left auricle is extremely thin, so the risk of damage to the left auricle is greatly reduced; the three-dimensional spiral structural design of the first bending part 11 or the second bending part 12 facilitates the addition of a coil to be shaped on the first current-blocking film 40, and the first current-blocking film 40 can be fixed on the device without additionally arranging the limiting structure 16, so that the first current-blocking film 40 can not slide or fall off randomly.
Example 6
As shown in fig. 9a to 9d, based on the device provided in embodiment 5, this embodiment is different from embodiment 5 in that the adaptive cavity device provided in this embodiment has only a three-dimensional spiral structure, i.e., a spring structure.
In this embodiment, as shown in fig. 9b, the collecting portion 30 is composed of 3 independent springs, each spring is formed by winding three medical metal wires together, and the manner of forming a collecting point by 3 springs is shown in fig. 1 f. The spring at the proximal end of the convergence portion 30 is split into two to form a wave-like structure of the transition section 13, wherein one wave band is a spring wound by 2 wires together, and the other wave band is a spring wound by 1 wire. The tail end of one of the 2 wires at the proximal end of the transition piece 13 is made as a J-hook 141, while the spring wound by the other wire merges with the spring on the other side of the adjacent wave structure to form the second bend 12, the first bend 11 and the central end 20 of the anchor stent 10.
In this embodiment, the self-adaptive cavity device has only one structure, which not only has the advantages of embodiments 1-5, but also is more flexible due to the whole spring structure, and can adapt to the left auricle with openings of various shapes without correcting the shape of the left auricle, thereby reducing the risk of postoperative complications such as pericardial effusion, pericardial tamponade and pericardial perforation.
Example 7
As shown in fig. 10a and 10b, based on the apparatus provided in embodiment 1, the present embodiment is different from embodiment 1 in that: the adaptive structures of the first bending part 11, the second bending part 12 and the collecting part 30 are two-dimensional S-shaped structures, and the device for the adaptive cavity provided by the embodiment is formed by cutting and shaping medical metal pipes.
In this embodiment, the advantage of two-dimensional S-shaped structural design has: compared with a three-dimensional spiral structure, the device is cut integrally and is simple to manufacture; secondly, a certain radial supporting force, namely shape retaining force, is provided; the two-dimensional S-shaped structure of the first bending part 11 is convenient for adding coils and shaping the coils to the first current-blocking film without additionally arranging a limiting structure; and compared with the three-dimensional spiral structure, the sheath retracting and exiting resistance is smaller.
Example 8
As shown in fig. 11, embodiment 8 is based on embodiment 1, and the difference between this embodiment and embodiment 1 is that: the self-adaptive lumen device further comprises a blocking disk 60, the blocking disk 60 being fixedly connected to the central end portion 20.
The occluding disk 60 is made of a material that has elasticity and/or shape memory and can be placed in or at the mouth of a biological cavity. The proximal disc surface of the blocking disc 60 is provided with a second flow blocking membrane 50, which further improves the blocking effect of the device for self-adapting cavities. The proximal end of the plugging disc 60 is provided with a detachable connection structure for facilitating connection with a transmission cable.
The embodiments of the present invention have been described in detail, but the embodiments are merely examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.

Claims (10)

1. A device of a self-adaptive cavity comprises a central end part and an anchoring support (10), wherein the anchoring support (10) is formed by surrounding a plurality of elastic supporting rods diverged from the central end part, and is characterized in that a self-adaptive structure is arranged on a local area or a whole area of each supporting rod of the anchoring support (10), and when the anchoring support (10) is extruded by the inner wall of the cavity, the self-adaptive structure immediately makes a bending deformation reaction, so that the anchoring support (10) is attached to the inner wall of the cavity in a self-adaptive manner.
2. The adaptive cavity device according to claim 1, wherein the anchor support (10) extends from the central end portion to a first curved portion (11) which is concave towards the distal end, extends from an end of the first curved portion (11) far away from the central end portion (20) to a second curved portion (12) which is convex towards the proximal end, and extends from an end of the second curved portion (12) far away from the first curved portion (11) to a transition portion (13) which is convex towards the distal end; the support rods are circumferentially and rotationally symmetrical along the central axis of the central end part (20) to form the bowl-shaped anchoring support (10); in the transition part (13), a plurality of support rods are connected end to form a wave-shaped structure; an anchoring structure (14) is arranged on the anchoring bracket (10).
3. The adaptive lumen device of claim 1, further comprising a collection portion (30) extending from the distal end of the anchor stent (10) in a direction near the central axis of the central end portion (20) and collecting at a collection point, such that the device is formed into a cage shape, wherein an adaptive structure is provided at the collection portion (30).
4. The adaptive cavity apparatus of any of claims 1-3, wherein the flexural modulus of the adaptive structure is no more than 1/10 of the flexural modulus of the non-adaptive structure.
5. The adaptive cavity device according to claim 4, wherein the adaptive structure is a three-dimensional spiral structure, the three-dimensional spiral structure is a spring, the wire diameter of the spring is 0.05-0.2mm, and the overall diameter of the spring is 0.2-1 mm; or the self-adaptive structure is a two-dimensional S-shaped structure, and the solid rod width of the two-dimensional S-shaped structure is less than or equal to 1/2 of the whole width; or the adaptive structure is a linear structure, and the minimum cross-sectional area in the linear structure is not more than 1/2 of the cross-sectional area of the non-adaptive structure.
6. The adaptive chamber device according to claim 5, wherein the adaptive structure of the pooling portion (30) is a three-dimensional spiral type structure, which is a spring; the supporting rods correspond to the springs in number and position one by one, the supporting rods are connected with one ends of the springs, and the other ends of the springs are converged to form a convergence point; or the quantity of bracing piece is the even number, the quantity of spring does the quantity of bracing piece is half, many the bracing piece is connected with many the both ends of spring, many the spring alternates each other in the middle zone of every spring and twines the realization and connect to form the collection point.
7. The adaptive chamber device according to claim 5, wherein the adaptive structure of the collection portion (30) is a two-dimensional S-shaped structure.
8. The adaptive cavity apparatus according to claim 1, wherein a transition connecting structure is disposed on the support rod, and a portion of the adaptive structure is wound around the transition connecting structure, such that the transition connecting structure and the adaptive structure form a buffer connecting region; or the support rod is provided with an enhanced connecting structure, and the self-adaptive structure forms limiting connection or fixed connection at the enhanced connecting structure.
9. A self-adapting chamber assembly according to any one of claims 5 to 8, wherein one end of the self-adapting structure, when connected to the support rod, extends beyond the anchoring support (10) and forms an anchoring structure (14).
10. The adaptive chamber device according to claim 1, further comprising a first fluid-blocking film (40), wherein the first fluid-blocking film (40) is composed of a multi-layer wrapping film, and the multi-layer wrapping film wraps the support rod of the anchor bracket (10); the anchoring support (10) is provided with a membrane connecting structure, the membrane connecting structure comprises at least one coil (15) and/or a limiting structure (16), the coil (15) and the limiting structure (16) are matched with each other, and the coated membrane is fixedly connected with the anchoring support (10).
CN202010725676.2A 2020-07-24 2020-07-24 Device of self-adaptation cavity Pending CN111839644A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114617603A (en) * 2020-12-10 2022-06-14 先健科技(深圳)有限公司 Plugging device

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114617603A (en) * 2020-12-10 2022-06-14 先健科技(深圳)有限公司 Plugging device
WO2022121630A1 (en) * 2020-12-10 2022-06-16 先健科技(深圳)有限公司 Occlusion device
CN114617603B (en) * 2020-12-10 2024-04-02 先健科技(深圳)有限公司 Plugging device

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