CN116570338A - Left auricle occluder and placement method - Google Patents
Left auricle occluder and placement method Download PDFInfo
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- CN116570338A CN116570338A CN202310855093.5A CN202310855093A CN116570338A CN 116570338 A CN116570338 A CN 116570338A CN 202310855093 A CN202310855093 A CN 202310855093A CN 116570338 A CN116570338 A CN 116570338A
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- 238000000034 method Methods 0.000 title claims abstract description 15
- 210000003205 muscle Anatomy 0.000 claims abstract description 46
- 210000005248 left atrial appendage Anatomy 0.000 claims description 37
- 230000000903 blocking effect Effects 0.000 claims description 16
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 4
- 239000013013 elastic material Substances 0.000 claims description 3
- 230000006378 damage Effects 0.000 abstract description 11
- 239000012528 membrane Substances 0.000 description 14
- 210000005246 left atrium Anatomy 0.000 description 12
- 230000006870 function Effects 0.000 description 10
- 208000007536 Thrombosis Diseases 0.000 description 8
- 208000027418 Wounds and injury Diseases 0.000 description 8
- 208000014674 injury Diseases 0.000 description 8
- 238000004873 anchoring Methods 0.000 description 6
- 206010003658 Atrial Fibrillation Diseases 0.000 description 4
- 230000009471 action Effects 0.000 description 4
- 230000008602 contraction Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- 208000006017 Cardiac Tamponade Diseases 0.000 description 2
- 208000005189 Embolism Diseases 0.000 description 2
- 208000005228 Pericardial Effusion Diseases 0.000 description 2
- 208000006011 Stroke Diseases 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 210000002837 heart atrium Anatomy 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 230000001746 atrial effect Effects 0.000 description 1
- 230000002457 bidirectional effect Effects 0.000 description 1
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- 239000008280 blood Substances 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- 230000001269 cardiogenic effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
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- 239000000463 material Substances 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- -1 polytetrafluoroethylene Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 238000002601 radiography Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12177—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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- Surgery (AREA)
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- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
The invention discloses a left auricle plugging device which comprises a plugging unit and a grapple unit, wherein the plugging unit can be contracted and expanded, when the plugging device is placed, the plugging unit is in a contracted state, and after the grapple unit is fixed on a comb muscle in a special form in a human left auricle, the plugging unit is expanded to plug the human left auricle. According to the left auricle plugging device, the grapple units are detachably connected with the plugging units, and the grapple units with proper specifications can be selected according to actual conditions so as to adapt to different patients, improve the flexibility and adaptability of the plugging device, and reduce the damage to the patients caused by placing the plugging device. Meanwhile, the grapple unit is fixed on the comb muscle in a special form in the left auricle of the human body, so that the placement stability of the left auricle occluder is improved, the situation that the left auricle occluder leaks or falls off is prevented, the occlusion reliability is improved, and meanwhile, the inner wall of the left auricle of the human body is prevented from being punctured and fixed. The invention also provides a placement method of the left auricle occluder.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a left auricle occluder and a placement method.
Background
For patients with atrial fibrillation or with high CHA 2 DS 2 A patient with a score of vacc (atrial fibrillation stroke risk score), a left atrial appendage occlusion device is typically used to occlude the left atrial appendage of the patient to isolate the left atrium and prevent thrombus from falling off the left atrial appendage from entering the blood circulation to initiate an embolic event. The left auricle occluder is made of a metal bracket and polymerThe metal structure of the device mainly comprises two parts, namely a plugging disc and a plugging net. The blocking disc and the blocking net are provided with blocking films. The shutoff dish is drum network structure, and the shutoff membrane is fixed and covers at shutoff dish inner wall, and the shutoff net is cake network structure, and the shutoff membrane is fixed and covers at shutoff net inner wall. The plugging disc and the plugging net are connected through the base at the center of each of the plugging disc and the plugging net by using a connecting rod or a bracket.
The plugging function of the left auricle plugging device is jointly realized by a plugging disc, a plugging net and a plugging film therein, wherein the plugging disc realizes the position fixation of the plugging device and the inside of the left auricle, the plugging net is positioned in an atrium, and the plugging net has the function of endothelializing the plugging device on the structural basis of the left atrium part by atrial endothelial cells and also has the fixation function. The combined action of the blocking disc and the blocking net enables the left auricle blocking device to realize bidirectional fixation at the opening of the left auricle at the left atrium, wherein the movement of the blocking device in the left auricle is blocked by the blocking net, and the movement in the left atrium is pulled by the anchoring hook. The sealing disc and the sealing net are made of polytetrafluoroethylene sealing films, which allow red blood cells to pass through and prevent the fallen thrombus from entering the left atrium from the left auricle.
When the left auricle plugging device is not placed, the folding umbrella shape is stored in the conveying sheath, the plugging disc plugging net is made of nickel-titanium alloy, has ductility and memory, and can be respectively unfolded into a plug-shaped structure and a net-shaped structure after being released.
In the left auricle occluder placing process, the conveying sheath conveys the folded occluder from the left atrium to the left auricle, the relative position of the top end of the conveying sheath and the left auricle is determined through the locating ring under real-time radiography, the bottom end of the occluder is pushed to the deep part of the left auricle to be connected with the guide wire, and meanwhile, the conveying sheath is retracted, so that the left auricle occluder is released from the conveying sheath. The plugging disc is unfolded in the left auricle and is in a plug-shaped structure, an anchoring hook is arranged on a metal supporting rod of the structure, and an operator pulls the guide wire plugging device to enable the anchoring hook on the plugging disc to penetrate into the inner wall of the left auricle so as to fix the plugging device. And continuing to withdraw the delivery sheath, unfolding the blocking net, and covering the left auricle opening from one side of the left atrium by the blocking net. If the placement position is poor and the replacement is needed, the conveying sheath is pushed forward, so that the left atrial appendage occlusion device loses the supporting function under the compression of the opening of the conveying sheath, and the umbrella-shaped device is folded back into the conveying sheath to realize the recovery function so as to be replaced. And after the placement is successful, the guide wire is screwed off, the delivery sheath is withdrawn, and the placement of the left atrial appendage occlusion device is completed.
The human left auricle has a complex and various structure, the inner wall of the left auricle is provided with a gully formed by comb muscles, and in the heart structure of part of patients, comb muscles with special forms, the two ends of which are connected with the inner wall of the left auricle, and the middle of which is not connected with the inner wall of the left auricle, exist. In the journal entitled headrest, articles published in 2013: anatomical characteristics of the left atrial appendage in cardiogenic stroke with low CHADS 2 The effect of this special form of comb muscle on the blood flow field in the left atrial appendage is shown in the final image of the score (DOI: 10.1016/j. Hrthm. 2013.01.036), which demonstrates the presence of this physiological structure, i.e. the special form of comb muscle. If the left atrial appendage occlusion device is not fully attached to the inner wall of the left atrial appendage due to the influence of the pectinate muscles when placed, a gap exists between the occlusion device and the inner wall of the left atrial appendage, and the risk that the detached thrombus enters the left atrium along with blood into the systemic blood vessel exists, so that an embolism event can occur to a patient.
Although various optimizations are carried out on structural design, the structure of the left auricle occluder is composed of an independent plug-shaped structure, an occluding disc and an occluding net, so that the success rate of blocking the fallen thrombus is further increased, and the endothelialization process of the left atrium on the left auricle occluder is optimized. At present, when the left auricle occluder is placed, in order to enable the anchoring hook to stably penetrate into the inner wall of the left auricle so as to achieve the effect of fixing the occluding disc, an operator is required to pull the left auricle outwards, the whole placement position of the left auricle occluder is deviated to one side of the left atrium in the left auricle of the left atrium, the occluding grid should be tightly attached to cover the opening Zuo Xiner originally, but because the pulling causes the imprecise covering, gaps exist between the occluding grid and the auricle wall, leakage is formed, and DRT (device-related thrombosis related thrombus) possibly occurs. Simultaneously, pull the shutoff dish with force, probably lead to the anchoring hook on the shutoff dish to lead to the fact tearing injury to left auricle inner wall. If the placement is not good, the plugging disc needs to be retracted, the anchoring hook is penetrated into the inner wall of the left auricle again, and the process of 'release deployment-traction-penetration' is performed again, so that more damage to a patient can be caused. The diameter of the plugging net and the plugging disc can be changed by the existing left auricle plugging device, but the problem of poor adaptability still exists because the structure of the left auricle of the human body is complex and various, and the placing process still easily causes injury to patients.
Therefore, how to change the current situation that the left atrial appendage occlusion device has poor adaptability and is easy to cause injury to patients in the prior art becomes a problem to be solved urgently by those skilled in the art.
Disclosure of Invention
The invention aims to provide a left auricle occluder and a placement method, which are used for solving the problems in the prior art, improving the adaptability of the left auricle occluder and reducing the injury to a patient caused by placing the occluder.
In order to achieve the above object, the present invention provides the following solutions: the invention provides a left auricle occluder, comprising:
the plugging unit can be contracted and expanded, and can plug the left auricle of the human body when being expanded;
the grapple unit is detachably connected with the plugging unit and can be fixed on the comb muscle in a special form in the left auricle of the human body.
Preferably, the plugging unit comprises a first plugging film, a bracket component and a second plugging film, wherein the first plugging film is connected with the second plugging film by the bracket component, the first plugging film, the bracket component and the second plugging film are made of elastic materials, in a free state, the first plugging film and the second plugging film are of bowl-shaped structures, and openings of the first plugging film and the second plugging film are arranged towards a direction far away from the bracket component.
Preferably, the bracket assembly comprises an inner bracket wire, an inner bracket base, an outer bracket wire and an outer bracket base, wherein the inner bracket base is positioned at the closing end of the first plugging film and is connected with the closing end of the first plugging film, one end of the inner bracket wire is connected with the opening end of the first plugging film, and the other end of the inner bracket wire is connected with the inner bracket base; the outer support base is located at the closing end of the second plugging film and is connected with the second plugging film, and the outer support wire is connected with the first plugging film and the outer support base.
Preferably, the number of the inner stent wires and the number of the outer stent wires are multiple, and the inner stent wires and the outer stent wires are circumferentially and uniformly distributed around the axis of the first blocking film and the second blocking film.
Preferably, the shape of the inner stent wire is consistent with the outline of the first plugging film; the outer support wires are also connected with auxiliary support wires, the auxiliary support wires are arranged between two adjacent outer support wires, and the auxiliary support wires are X-shaped.
Preferably, the plugging unit further comprises a plugging net, the plugging net cover is arranged outside the second plugging film, the shape of the plugging net is matched with that of the second plugging film, the closing end of the plugging net is connected with the outer support base, and the plugging net is woven by nickel-titanium alloy wires.
Preferably, the inner support base and the outer support base are both detachably connectable with the guide wire of the delivery sheath.
Preferably, the grapple unit includes grapple base, spring, grab pole and the shackle that link to each other in proper order, the grapple base with the shutoff unit can dismantle and be connected, the shackle can be hooked on the comb muscle of the special form in human left auricle and realize fixing.
Preferably, the shackle is of a ring-shaped structure with a notch, the number of the shackle is multiple, and the hooks are uniformly distributed circumferentially around the axis of the grabbing rod.
The invention also provides a placement method of the left auricle occluder, which is characterized in that the occluder unit is in a contracted state, the left auricle occluder is conveyed into the left auricle of a human body, one end of the grapple unit, which is far away from the occluder unit, is fixed on the comb muscle in a special form in the left auricle of the human body, so that the occluder unit is unfolded, and the occluder unit occludes the left auricle of the human body.
Compared with the prior art, the invention has the following technical effects:
according to the left auricle occluder disclosed by the invention, the occluding unit can be contracted and expanded, when the occluder is placed, the occluding unit is in a contracted state, and the grapple unit is fixed on the comb muscle in a special form in the left auricle of a human body, so that the occluding unit is expanded to occlude the left auricle of the human body. According to the left auricle plugging device, the grapple units are detachably connected with the plugging units, and the grapple units with proper specifications can be selected according to actual conditions so as to adapt to different patients, improve the flexibility and adaptability of the plugging device, and reduce the damage to the patients caused by placing the plugging device. Meanwhile, the grapple unit is fixed on the comb muscle in a special form in the left auricle of a human body, the comb muscle in a special form exists in the left auricle of a part of patients, under the condition of atrial fibrillation, the contraction function of the left auricle disappears, the comb muscle does not have the contraction function any more, and is one of reasons for increasing the risk of thrombus generation in the left auricle, but the position of the comb muscle is relatively fixed, and the grapple unit is a muscle tissue and has certain toughness, so that the grapple unit is used as a fixed point for fixing the left auricle occluder, improves the placement stability of the left auricle occluder, prevents the left auricle occluder from leaking or falling off, improves the occlusion reliability, and avoids puncturing and fixing the inner wall of the left auricle of the human body, thereby further reducing the injury to the patients caused by the placement of the left auricle occluder.
The invention also provides a placement method of the left auricle occluder, which utilizes the occluder unit to occlude the left auricle, and simultaneously utilizes the grapple unit to be fixed on the comb muscle of a special form in the left auricle of the human body, thereby avoiding the penetration of the inner skin of the left auricle and reducing the occurrence of pericardial effusion and cardiac tamponade complications in the occlusion operation.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is an isometric view of a left atrial appendage occlusion device as disclosed in embodiments of the present invention;
fig. 2 is a front view of a left atrial appendage occlusion device as disclosed in embodiments of the present invention;
FIG. 3 is a top view of a left atrial appendage occlusion device as disclosed in embodiments of the present invention;
FIG. 4 is a side view of a left atrial appendage occlusion device as disclosed in embodiments of the present invention;
fig. 5 is a schematic structural view of a grapple unit of the left atrial appendage occlusion device disclosed in the embodiment of the present invention;
fig. 6 is a schematic illustration of placement of a left atrial appendage occlusion device as disclosed in an embodiment of the present invention.
Wherein 100 is a plugging unit, and 200 is a grapple unit;
1 is a first plugging film, 2 is a bracket component, 3 is a second plugging film, 4 is an inner bracket wire, 5 is an inner bracket base, 6 is an outer bracket wire, 7 is an outer bracket base, 8 is an auxiliary bracket wire, 9 is a plugging net, 10 is a grapple base, 11 is a spring, 12 is a grab bar, 13 is a shackle, 14 is a binding wire, 15 is a conveying sheath, and 16 is a guide wire.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. 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.
The invention aims to provide a left auricle occluder and a placement method, which are used for solving the problems in the prior art, improving the adaptability of the left auricle occluder and reducing the injury to a patient caused by placing the occluder.
In order that the above-recited objects, features and advantages of the present invention will become more readily apparent, a more particular description of the invention will be rendered by reference to the appended drawings and appended detailed description.
The invention provides a left auricle occluder, which comprises an occluder unit 100 and a grapple unit 200, wherein the occluder unit 100 can be contracted and expanded, and the occluder unit 100 can occlude the left auricle of a human body when being expanded; the grapple unit 200 is detachably connected with the blocking unit 100, and the grapple unit 200 can be fixed on a specific form of comb muscle in the left atrial appendage of a human body.
According to the left auricle occluder disclosed by the invention, the occluding unit 100 can be contracted and expanded, when the occluder is placed, the occluding unit 100 is in a contracted state, the grapple unit 200 is fixed on the comb muscle in a special form in the left auricle of a human body, and the occluding unit 100 is expanded to occlude the left auricle of the human body. According to the left auricle occluder, the grapple unit 200 is detachably connected with the occluder unit 100, and the grapple unit 200 with proper specification can be selected according to actual conditions so as to adapt to different patients, so that the flexibility and adaptability of the occluder are improved, and the injury to the patients caused by placing the occluder is reduced. Meanwhile, the grapple unit 200 of the present invention is fixed on the comb muscle of a special form in the left auricle of a human body, in the left auricle of a part of patients, there is a comb muscle of a special form, in case of atrial fibrillation, the contraction function of the left auricle disappears, such comb muscle no longer has the contraction function, which is one of the reasons causing the increase of the risk of thrombus formation in the left auricle, but the position of the comb muscle is relatively fixed, and because it is a muscle tissue, the comb muscle has a certain toughness, which is used as a fixing point for fixing the left auricle occluder, the placement stability of the left auricle occluder is improved, the leakage or falling off of the left auricle occluder is prevented, the reliability of occlusion is improved, and the grapple unit 200 is fixed on the comb muscle of a special form in the left auricle of a human body, so that the puncture fixation of the inner wall of the left auricle of a human body is avoided, thereby further reducing the injury to the patient caused by the placement of the left auricle occluder.
Specifically, the plugging unit 100 includes a first plugging membrane 1, a support assembly 2 and a second plugging membrane 3, the first plugging membrane 1 is connected with the second plugging membrane 3 by utilizing the support assembly 2, the first plugging membrane 1, the support assembly 2 and the second plugging membrane 3 are made of elastic materials, so that the plugging unit 100 can shrink, the left atrial appendage plugging device is conveniently conveyed by utilizing the conveying sheath 15, under the free state, the first plugging membrane 1 and the second plugging membrane 3 are of bowl-shaped structures, openings of the first plugging membrane 1 and the second plugging membrane 3 are arranged in a direction far away from the support assembly 2, after the plugging device is conveyed in place, and after the grapple unit 200 is fixed on a comb muscle of a special form in the left atrial appendage of a human body, the conveying sheath 15 is removed, the plugging unit 100 is automatically unfolded under the elastic action, and the left atrial appendage of the human body is plugged.
More specifically, the bracket assembly 2 comprises an inner bracket wire 4, an inner bracket base 5, an outer bracket wire 6 and an outer bracket base 7, wherein the inner bracket base 5 is positioned at the closing end of the first plugging film 1 and is connected with the closing end of the first plugging film 1, one end of the inner bracket wire 4 is connected with the opening end of the first plugging film 1, the other end of the inner bracket wire is connected with the inner bracket base 5, and the first plugging film 1 is supported by the inner bracket wire 4; the outer support base 7 is located the binding off end of second shutoff membrane 3 and the two link to each other, and outer support wire 6 is utilized to first shutoff membrane 1 links to each other with outer support base 7, improves the overall structure intensity of plugging device.
In order to further enhance the structural stability of the plugging device, the number of the inner support wires 4 and the number of the outer support wires 6 are multiple, the inner support wires 4 and the outer support wires 6 are circumferentially and uniformly distributed around the axis of the first plugging film 1 and the axis of the second plugging film 3, the structural strength of the plugging unit 100 is ensured, and meanwhile, the stress uniformity of the first plugging film 1 and the outer support base 7 is improved.
In this embodiment, the shape of the inner stent wire 4 is consistent with the outline of the first plugging film 1, so as to enhance the supporting stability of the inner stent wire 4 on the first plugging film 1, and further improve the plugging reliability of the plugging device. In order to further improve the support stability and reliability of the support assembly 2, the outer support wire 6 is further connected with an auxiliary support wire 8, the auxiliary support wire 8 is arranged between two adjacent outer support wires 6, the auxiliary support wire 8 is in an X shape, one end of the auxiliary support wire 8 is connected with one end of the outer support wire 6, which is close to the first plugging film 1, the other end of the auxiliary support wire 8 is connected with one end of the outer support wire 6, which is close to the outer support base 7, the auxiliary support wire 8 is matched with the outer support wire 6 to form a support net frame, and when the support assembly 2 is ensured to shrink along with the first plugging film 1 and the second plugging film 3, the structural stability of the plugging unit 100 in an unfolding state is ensured. It should be noted that, in order to enhance the connection between the external stent wire 6 and the first plugging film 1, the edge of the first plugging film 1 is fixed on the external stent wire 6 by using the binding wire 14, so that the support function of the stent assembly 2 on the first plugging film 1 can be enhanced by using the binding wire 14 while the connection is ensured.
Simultaneously, the plugging unit 100 further comprises a plugging net 9, the plugging net 9 is covered outside the second plugging film 3, the shape of the plugging net 9 is matched with the second plugging film 3, the plugging net 9 can provide stable support for the second plugging film 3 so as to ensure that the first plugging film 1 and the second plugging film 3 are matched to plug the left auricle of a human body and avoid leakage, the closing end of the plugging net 9 is connected with the outer support base 7, in the specific embodiment, the plugging net 9 is woven by nickel-titanium alloy wires, so that the plugging net 9 can shrink and expand along with the second plugging film 3, the plugging net 9 has memory while having ductility, and can expand to form a net structure when the second plugging film 3 is expanded so as to support the second plugging film 3. In other specific embodiments of the invention, the plugging net 9 can be made of other materials, so as to meet different working conditions and further improve the flexibility and adaptability of the plugging device.
It should be noted that, the inner support base 5 and the outer support base 7 can be detachably connected with the guide wire 16 of the delivery sheath 15, so as to realize that the guide wire 16 of the delivery sheath 15 drives the occluder to smoothly reach the delivery position and complete the release of the occluder. In this embodiment, inner support base 5 and outer support base 7 all can with seal wire 16 threaded connection, connect fastening, the dismouting is convenient, when seal wire 16 and inner support base 5 screw thread link to each other, seal wire 16 passes outer support base 7, further improves the simple operation nature.
In addition, the grapple unit 200 includes a grapple base 10, a spring 11, a grab bar 12, and a shackle 13, which are sequentially connected, the grapple base 10 is detachably connected with the plugging unit 100, the shackle 13 can be hooked on a comb muscle of a special shape (the shackle 13 is hooked on a middle portion of the comb muscle of the special shape, which is not connected with an inner wall of a left auricle), so as to achieve fixation, in this embodiment, the grapple base 10 is detachably connected with the inner bracket base 5, the spring 11 is disposed between the grapple base 10 and the grab bar 12, the spring 11 can play a buffering role when the shackle 13 is fixed, and other types of elastic pieces can be selected according to actual operation needs in practical applications.
It should be emphasized that, the shackle 13 has a ring structure with a notch, so that the shackle 13 can hook the comb muscle with a special shape, and the grabbing stability is ensured as much as possible while the operation is convenient. The number of the shackles 13 is one or more, a plurality of shackles 13 are circumferentially and uniformly distributed around the axis of the grabbing rod 12, a plurality of grabbing hook units 200 can be arranged for meeting different fixing requirements, the number of shackles 13 of each grabbing hook unit 200 is different, the grabbing hook base 10 is in threaded connection with the inner support base 5, replacement is convenient, and flexible adaptability of the left auricle plugging device is improved.
Furthermore, the invention also provides a placement method of the left auricle occluder, which is characterized in that the occluder unit 100 is in a contracted state, the left auricle occluder is conveyed into the left auricle of a human body, one end of the grapple unit 200, which is far away from the occluder unit 100, is fixed on the comb muscle in a special form in the left auricle of the human body, the occluder unit 100 is unfolded, the occluder unit 100 occludes the left auricle of the human body, the occluder unit 100 is utilized to occlude the left auricle, and meanwhile, the grapple unit 200 is fixed on the comb muscle in the special form in the left auricle of the human body, so that the penetration of the endothelium of the left auricle is avoided, and the occurrence of pericardial effusion and cardiac tamponade complications in the occlusion operation is reduced.
When the left atrial appendage occlusion device of the present invention is placed, please refer to fig. 6, the delivery sheath 15 delivers the contracted left atrial appendage occlusion device into the left atrial appendage, the guide wire 16 is pushed to push the contracted left atrial appendage occlusion device out of the delivery sheath 15, the grapple unit 200 is exposed first, the guide wire 16 and the delivery sheath 15 are manipulated to make the grapple ring 13 hook on the comb muscle of the special form (the shackle 13 hooks on the middle of the comb muscle of the special form which is not connected to the inner wall of the left atrial appendage) to achieve fixation; after the grabbing is completed, the guide wire 16 is kept still, the conveying sheath 15 is retracted (the conveying sheath 15 is moved towards the direction away from the left auricle), the outer support wire 6 and the plugging net 9 are exposed, the guide wire 16 is rotated, the guide wire 16 is separated from the inner support base 5, the guide wire 16 and the outer support base 7 are connected by screwing, the conveying sheath 15 is retracted to the outer support base 7, at the moment, the conveying sheath 15 does not exert acting force on the contracted left auricle plugging device, but the plugging device cannot be unfolded under the constraint of the left auricle; the guide wire 16 is further retracted, so that the plugging net 9 is completely withdrawn from the left auricle, and the plugging net 9 and the second plugging film 3 are unfolded under the action of self elastic force. Simultaneously, the stent component 2 loses the constraint of the plugging net 9 and is fully opened, the six outer stent wires 6 pull the first plugging film 1 to be unfolded towards the inner wall of the left auricle, and simultaneously, the stretching force for unfolding the inner stent wires 4 is given, the auxiliary stent wires 8 are unfolded, and the outer stent wires 6 are supported; the inner support wire 4 is spread to the periphery under the action of self elasticity, the edges of the outer support wire 6 and the first plugging film 1 are tightly attached to the inner wall of the left auricle, and simultaneously, a pulling force towards the inside of the left auricle is applied to the left auricle plugging device, so that the plugging net 9 is tightly attached to one side of an atrium to plug the left auricle; and rotating the guide wire 16 to separate the guide wire 16 from the outer bracket base 7, so as to complete the placement of the left atrial appendage occlusion device. It should be noted that the delivery sheath 15 and the guide wire 16 are conventional methods for those skilled in the art, and will not be described in detail herein.
The left auricle plugging device can apply tension to the left auricle plugging device from the inside of the left auricle, the tension acts on the plugging net 9 to enable the left auricle plugging device to be tightly attached to one side of the left atrium to cover the left auricle opening, and the grapple unit 200 is fixed on the pectinate muscle in a special form in the left auricle of a human body, so that the left auricle plugging device is more stably fixed, and the situation that the left auricle plugging device leaks or falls off is prevented; the different grapple units 200 can be replaced according to individual differences of the comb muscles with special forms, the fitting effect of the left auricle occluder is enhanced, and the occlusion is tighter.
Noun interpretation:
comb muscle of special morphology: the inner wall of the left auricle of the human body is provided with comb muscles, in the left auricle of a part of the human body, the conditions that two ends of the comb muscles are connected with the inner wall of the left auricle and the middle part of the comb muscles is not connected with the inner wall of the left auricle exist, the comb muscles which are not connected with the inner wall of the left auricle in the middle part are called as comb muscles in special forms, and gaps are reserved between the middle parts of the comb muscles in special forms and the inner wall of the left auricle.
The principles and embodiments of the present invention have been described in detail with reference to specific examples, which are provided to facilitate understanding of the method and core ideas of the present invention; also, it is within the scope of the present invention to be modified by those of ordinary skill in the art in light of the present teachings. In view of the foregoing, this description should not be construed as limiting the invention.
Claims (10)
1. A left atrial appendage occlusion device comprising:
the plugging unit can be contracted and expanded, and can plug the left auricle of the human body when being expanded;
the grapple unit is detachably connected with the plugging unit and can be fixed on the comb muscle in a special form in the left auricle of the human body.
2. The left atrial appendage occlusion device of claim 1, wherein: the plugging unit comprises a first plugging film, a support assembly and a second plugging film, wherein the first plugging film is connected with the second plugging film by the support assembly, the first plugging film, the support assembly and the second plugging film are made of elastic materials, in a free state, the first plugging film and the second plugging film are of bowl-shaped structures, and openings of the first plugging film and the second plugging film are arranged towards a direction far away from the support assembly.
3. The left atrial appendage occlusion device of claim 2, wherein: the bracket assembly comprises an inner bracket wire, an inner bracket base, an outer bracket wire and an outer bracket base, wherein the inner bracket base is positioned at the closing end of the first plugging film and is connected with the closing end of the first plugging film, one end of the inner bracket wire is connected with the opening end of the first plugging film, and the other end of the inner bracket wire is connected with the inner bracket base; the outer support base is located at the closing end of the second plugging film and is connected with the second plugging film, and the outer support wire is connected with the first plugging film and the outer support base.
4. A left atrial appendage occlusion device as in claim 3, wherein: the number of the inner support wires and the number of the outer support wires are multiple, and the inner support wires and the outer support wires are circumferentially and uniformly distributed around the axis of the first blocking film and the second blocking film.
5. A left atrial appendage occlusion device as in claim 3, wherein: the shape of the inner support wire is consistent with the outline of the first plugging film; the outer support wires are also connected with auxiliary support wires, the auxiliary support wires are arranged between two adjacent outer support wires, and the auxiliary support wires are X-shaped.
6. A left atrial appendage occlusion device as in claim 3, wherein: the plugging unit further comprises a plugging net, the plugging net cover is arranged outside the second plugging film, the shape of the plugging net is matched with that of the second plugging film, the closing end of the plugging net is connected with the outer support base, and the plugging net is woven by nickel-titanium alloy wires.
7. The left atrial appendage occlusion device of any one of claims 3-6, wherein: the inner support base and the outer support base can be detachably connected with the guide wire of the conveying sheath.
8. The left atrial appendage occlusion device of any one of claims 1-6, wherein: the grapple unit comprises a grapple base, a spring, a grapple rod and a shackle which are sequentially connected, wherein the grapple base is detachably connected with the plugging unit, and the shackle can be hooked on the comb muscle of a special form in the left auricle of a human body and is fixed.
9. The left atrial appendage occlusion device of claim 8, wherein: the shackle is of a ring-shaped structure with a notch, the number of the shackle is multiple, and the hooks are circumferentially and uniformly distributed around the axis of the grabbing rod.
10. A method of placement of a left atrial appendage occlusion device as in any one of claims 1-9, wherein: the plugging unit is in a contracted state, the left auricle plugging device is conveyed into the left auricle of the human body, one end of the grapple unit, which is far away from the plugging unit, is fixed on the comb muscle in a special form in the left auricle of the human body, so that the plugging unit is unfolded, and the plugging unit plugs the left auricle of the human body.
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| CN202310855093.5A CN116570338B (en) | 2023-07-13 | 2023-07-13 | Left auricle occluder and placement method |
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| CN202310855093.5A CN116570338B (en) | 2023-07-13 | 2023-07-13 | Left auricle occluder and placement method |
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| CN212879439U (en) * | 2020-07-28 | 2021-04-06 | 宁波迪创医疗科技有限公司 | Left auricle occluder with bionic micro-thorn attachment structure |
| CN113116407A (en) * | 2019-12-31 | 2021-07-16 | 先健科技(深圳)有限公司 | Plugging device |
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| CN105434082A (en) * | 2014-09-16 | 2016-03-30 | 徐州亚太科技有限公司 | Left auricle plugging device |
| WO2016049991A1 (en) * | 2014-09-29 | 2016-04-07 | 上海形状记忆合金材料有限公司 | Left atrial appendage occlusion apparatus |
| WO2018219151A1 (en) * | 2017-06-02 | 2018-12-06 | 上海微创医疗器械（集团）有限公司 | Medical apparatus |
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| CN116570338B (en) | 2023-10-10 |
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