CN113116447A - Left auricle ablation plugging device - Google Patents
Left auricle ablation plugging device Download PDFInfo
- Publication number
- CN113116447A CN113116447A CN201911426001.1A CN201911426001A CN113116447A CN 113116447 A CN113116447 A CN 113116447A CN 201911426001 A CN201911426001 A CN 201911426001A CN 113116447 A CN113116447 A CN 113116447A
- Authority
- CN
- China
- Prior art keywords
- atrial appendage
- ablation
- left atrial
- occlusion device
- guide
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000002679 ablation Methods 0.000 title claims abstract description 117
- 230000002093 peripheral effect Effects 0.000 claims abstract description 16
- 210000005248 left atrial appendage Anatomy 0.000 claims description 141
- 229910000831 Steel Inorganic materials 0.000 claims description 54
- 239000010959 steel Substances 0.000 claims description 54
- 238000007789 sealing Methods 0.000 claims description 53
- 229910052751 metal Inorganic materials 0.000 claims description 50
- 239000002184 metal Substances 0.000 claims description 50
- 238000004873 anchoring Methods 0.000 claims description 36
- 238000005520 cutting process Methods 0.000 claims description 19
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 12
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 claims description 6
- 238000010276 construction Methods 0.000 claims description 3
- 238000012800 visualization Methods 0.000 claims description 3
- 229920001971 elastomer Polymers 0.000 claims description 2
- 208000014674 injury Diseases 0.000 claims description 2
- 239000000126 substance Substances 0.000 claims description 2
- 230000008733 trauma Effects 0.000 claims description 2
- 238000002604 ultrasonography Methods 0.000 claims description 2
- 239000000155 melt Substances 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 230000003247 decreasing effect Effects 0.000 claims 1
- 238000009413 insulation Methods 0.000 description 18
- 239000011248 coating agent Substances 0.000 description 14
- 238000000576 coating method Methods 0.000 description 14
- 206010003658 Atrial Fibrillation Diseases 0.000 description 11
- 230000006870 function Effects 0.000 description 11
- 230000000903 blocking effect Effects 0.000 description 8
- 239000012528 membrane Substances 0.000 description 8
- 238000000034 method Methods 0.000 description 8
- 239000004810 polytetrafluoroethylene Substances 0.000 description 8
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 8
- 230000001788 irregular Effects 0.000 description 7
- 239000008280 blood Substances 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 6
- 238000002513 implantation Methods 0.000 description 6
- 239000004813 Perfluoroalkoxy alkane Substances 0.000 description 5
- 230000009471 action Effects 0.000 description 5
- 229920000840 ethylene tetrafluoroethylene copolymer Polymers 0.000 description 5
- 229920009441 perflouroethylene propylene Polymers 0.000 description 5
- 229920011301 perfluoro alkoxyl alkane Polymers 0.000 description 5
- 238000005507 spraying Methods 0.000 description 5
- 210000001519 tissue Anatomy 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 238000009958 sewing Methods 0.000 description 4
- 238000007493 shaping process Methods 0.000 description 4
- 238000003466 welding Methods 0.000 description 4
- 238000007731 hot pressing Methods 0.000 description 3
- 239000011810 insulating material Substances 0.000 description 3
- 238000002955 isolation Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000007769 metal material Substances 0.000 description 3
- 230000010412 perfusion Effects 0.000 description 3
- 210000005077 saccule Anatomy 0.000 description 3
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 3
- 239000010902 straw Substances 0.000 description 3
- 208000007536 Thrombosis Diseases 0.000 description 2
- 206010003119 arrhythmia Diseases 0.000 description 2
- 230000006793 arrhythmia Effects 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 230000005611 electricity Effects 0.000 description 2
- 210000002837 heart atrium Anatomy 0.000 description 2
- 210000005246 left atrium Anatomy 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 2
- 229910052755 nonmetal Inorganic materials 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 229920000139 polyethylene terephthalate Polymers 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 238000009941 weaving Methods 0.000 description 2
- 238000004804 winding Methods 0.000 description 2
- 206010003662 Atrial flutter Diseases 0.000 description 1
- 229920002799 BoPET Polymers 0.000 description 1
- 206010014498 Embolic stroke Diseases 0.000 description 1
- 206010051814 Eschar Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 206010003668 atrial tachycardia Diseases 0.000 description 1
- 230000004323 axial length Effects 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 239000004020 conductor Substances 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 239000000110 cooling liquid Substances 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000002059 diagnostic imaging Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 210000001174 endocardium Anatomy 0.000 description 1
- 231100000333 eschar Toxicity 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 230000001121 heart beat frequency Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 239000012811 non-conductive material Substances 0.000 description 1
- 230000010355 oscillation Effects 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 229920000052 poly(p-xylylene) Polymers 0.000 description 1
- 238000007674 radiofrequency ablation Methods 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 230000037390 scarring Effects 0.000 description 1
- 238000004904 shortening Methods 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 238000009987 spinning Methods 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 229910052715 tantalum Inorganic materials 0.000 description 1
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Images
Classifications
-
- 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
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, 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
- 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
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1402—Probes for open surgery
-
- 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
-
- 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
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1407—Loop
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- Reproductive Health (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Physics & Mathematics (AREA)
- Plasma & Fusion (AREA)
- Otolaryngology (AREA)
- Surgical Instruments (AREA)
Abstract
The invention provides a left auricle ablation plugging device which comprises a supporting framework and an ablation piece arranged on the peripheral surface of the supporting framework, wherein a guide piece is arranged at the far end of the supporting framework, a connecting piece is arranged between the far end of the supporting framework and the guide piece, the connecting piece can swing relative to the axial lead of the supporting framework, the guide piece drives the connecting piece to bend until the ablation piece is attached to a proper position of the inner wall of the left auricle, the ablation piece is connected with an ablation energy source, and the ablation piece performs annular ablation on the inner wall of the left auricle.
Description
Technical Field
The invention relates to the technical field of interventional medical instruments, and relates to a left atrial appendage ablation plugging device.
Background
Atrial fibrillation (short for atrial fibrillation) is the most common persistent arrhythmia, and the incidence rate of atrial fibrillation is increased continuously with the increase of age, and the population over 75 years old can reach 10 percent. The exciting frequency of the atria during atrial fibrillation reaches 300-600 times per minute, the heartbeat frequency is often fast and irregular and sometimes reaches 100-160 times per minute, the heartbeat is much faster than that of a normal person and is absolutely irregular, and the atria lose effective contraction function. The incidence of atrial fibrillation is also closely related to coronary heart disease, hypertension, heart failure and other diseases.
The Left Atrial Appendage (LAA) is a small muscle pocket extending from the anterior lateral wall of the left atrium of the heart, and is not only the most prominent site for atrial fibrillation (atrial fibrillation) but also one of the critical areas for its occurrence and maintenance due to its special shape and structure. During a normal cardiac cycle, the left atrial appendage contracts with the left atrium to pump blood from the left atrial appendage, typically preventing blood from stagnating within the left atrial appendage. However, during cardiac cycles characterized by arrhythmias (e.g., atrial fibrillation), the left atrial appendage may not contract sufficiently, resulting in blood stagnation within the left atrial appendage. Stagnant blood within the left atrial appendage tends to clot and form a thrombus that falls out of the left atrial appendage and flows out of the heart blocking the vascular access that ultimately leads to embolic stroke and even death.
Some patients with atrial fibrillation benefit from active Left Atrial Appendage Isolation (LAAI). Such as atrial tachycardia, atrial flutter and atrial fibrillation. Energy is delivered from the ablation device to the endocardium and myocardial tissue. The delivered energy causes tissue scarring. The scar blocks the pulses emitted from within the tissue, thereby electrically disconnecting them or "isolating them from the heart. In some cases, the ablation procedure may thus provide for the restoration of a normal heart rhythm.
The position that present left atrial appendage occluder that has the function of melting can't melt the occluder according to the different forms of left atrial appendage, size adjustment left atrial appendage, consequently the position and the effect of difficult control ablation. In addition, abundant and thick pectinate muscles and small musculature are attached to the inner wall of the left auricle, and the anatomical morphology is complex, so that the stable plugging of the left auricle plugging device at the optimal position after release is difficult to guarantee by the existing left auricle ablation instrument.
Disclosure of Invention
The invention aims to provide a left atrial appendage ablation occlusion device stably released to a proper position, so as to ensure that the left atrial appendage ablation occlusion device is released to the optimal position in the left atrial appendage, so as to stably occlude an orifice of the left atrial appendage and enable ablation energy to form a complete at least one circle of ablation region on the inner wall of the left atrial appendage.
In order to solve the technical problem, the invention provides a left auricle ablation plugging device which comprises a supporting framework and an ablation piece arranged on the peripheral surface of the supporting framework, wherein a guide piece is arranged at the far end of the supporting framework, a connecting piece is arranged between the far end of the supporting framework and the guide piece, the connecting piece can swing relative to the axial lead of the supporting framework, the guide piece is inserted into the left auricle along the inner channel of the left auricle, the guide piece drives the connecting piece to bend until the ablation piece is attached to the proper position of the inner wall of the left auricle, the ablation piece is connected with an ablation energy source, and the ablation piece performs annular ablation on the inner wall of the left auricle.
The far end of the supporting framework of the left atrial appendage occlusion device is connected with a guide piece through a connecting piece, and the guide piece can swing relative to the axis of the supporting framework. Therefore, in the process of implanting the left auricle ablation plugging device into the inner cavity of the left auricle, the supporting framework can enter the inner cavity of the left auricle with irregular shape more smoothly under the guiding action of the guiding piece, so that the supporting framework can be stably released to the optimal position, the inner cavity of the left auricle can be stably plugged, and the implantation efficiency of the left auricle plugging device is improved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
Figure 1 is a schematic structural view of a left atrial appendage occlusion device provided in accordance with a first embodiment of the present invention;
figure 2 is an enlarged partial view of the left atrial appendage occlusion device of figure 1;
figure 3 is a schematic structural view of a left atrial appendage occlusion device provided in accordance with a second embodiment of the present invention;
figure 4 is an exploded schematic view of the left atrial appendage occlusion device of figure 3;
figure 5 is a schematic view of the left atrial appendage occlusion device of figure 3 in one of its states of use;
figure 6 is a schematic view of the left atrial appendage occlusion device of figure 3 in use;
figure 7 is a schematic structural view of a left atrial appendage occlusion device provided in accordance with a third embodiment of the present invention;
figure 8 is an enlarged partial view of the left atrial appendage occlusion device of figure 7;
figure 9 is a schematic view of a lead configuration of a left atrial appendage occlusion device provided in accordance with a fourth embodiment of the present invention;
FIG. 10 is a schematic structural diagram of a left atrial appendage occlusion device provided by a fifth embodiment of the invention
Figure 11 is a schematic structural view of the annular frame and the guide of a left atrial appendage occlusion device provided in accordance with a sixth embodiment of the present invention;
figure 12 is a schematic structural view of the ring frame and the guide of the left atrial appendage occlusion device of the seventh embodiment of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.
In the description of the present invention, the "proximal end" refers to the end relatively close to the operator during the operation, and the "distal end" refers to the end relatively far from the operator during the operation. Axial refers to the direction of the central axis of the device, and radial is the direction perpendicular to the central axis, and this definition is for convenience only and should not be construed as limiting the invention. The term "connection of component A to component B" means that component A is directly connected in contact with component B or component A is indirectly connected to component B through another component.
Referring to fig. 1 and 2, the present invention provides a left atrial appendage ablation occlusion device 100, which includes a support frame 20, an ablation element 40 disposed on an outer peripheral surface of the support frame 20, and a guide element 70 disposed at a distal end of the support frame 20, wherein a connecting element 72 is disposed between the distal end of the support frame 20 and the guide element 70, the connecting element 72 can swing relative to an axial line of the support frame 20, the guide element 70 is inserted into the left atrial appendage along an inner channel of the left atrial appendage, the guide element 70 drives the connecting element 72 to bend until the ablation element 40 is attached to an appropriate position of an inner wall of the left atrial appendage, so that the ablation element 40 is completely attached to the inner wall of the left atrial appendage, the ablation element 40 is connected with an ablation energy source, and the ablation element 40 is used for performing annular ablation on the inner wall of the left. The ablating member 40 is an ablation electrode that surrounds at least one turn in the circumferential direction of the support frame 20.
In this embodiment, the supporting framework 20 is formed by cutting and shaping a nickel-titanium alloy tube, and the supporting framework 20 is a "water drop" or "Mongolian" metal cutting stent in a completely released state; the guide part 70 is a hollow diamond-like structure, the radial dimension of the diamond-like structure is not more than 10mm, so that the guide part can reach the bottom of the left auricle along the inner wall of the left auricle, and the guide part 70 has a deviation rectifying and guiding function; the connecting piece 72 is the latch closure connecting portion of active connection tube structure, as shown in fig. 2, the connecting piece 72 includes two rings of cutting fashioned latch closures circle, leaves the space ground to seal and detain together, has both guaranteed the stability that guiding piece 70 is connected with support chassis 20 and has guaranteed the flexibility that guiding piece and support chassis 20 are connected for guiding piece 70 has preceding, back, left and right, upper and lower diversified dislocation swing, increases the flexibility of direction function. In other embodiments, the connecting member 72 can be a rotating shaft structure, a circular ring structure, a universal joint structure, a snap structure, a ball bearing structure, or the like.
The distal end of the support frame 20 of the left atrial appendage occlusion device 100 of the present invention is connected to the guide 70 by a swingable connection 72, so that the guide 70 can swing with respect to the axis of the support frame 20. Therefore, in the process of implanting the left atrial appendage ablation occlusion device 100 into the inner cavity of the left atrial appendage, the support framework 20 can enter the inner channel of the left atrial appendage with an irregular shape more smoothly under the guiding action of the guiding element 70, so that the support framework 20 can be stably released to an optimal position, thereby stably occluding and enabling the ablation element 40 to be completely attached to the inner wall of the left atrial appendage, and improving the implantation efficiency of the left atrial appendage occlusion device 100.
As shown in fig. 1, the support frame 20 is a self-expanding device, and the support frame 20 may be a resilient metal support frame or a resilient non-metal support frame. When the left atrial appendage occlusion device 100 is delivered through a sheath, the diameter of the support scaffold 20 may be contracted to a smaller state for delivery within the sheath; when the left atrial appendage occlusion device 100 is released in the heart, the guide member 70 guides the support frame 20 to smoothly enter the proper position in the inner cavity of the left atrial appendage, and the support frame 20 can be automatically expanded and the ablation member 40 on the outer wall of the support frame 20 can be completely attached to the inner wall of the opening of the left atrial appendage by adjusting the radial dimension of the support frame.
The supporting framework 20 can also be woven by silk material, or processed by combining local weaving with local tube cutting, and different parts can be welded or fixed with each other through connecting pieces. The tube is made of metal or nonmetal materials, the metal materials are preferably memory metal materials, and are preferably nickel-titanium alloy materials. The overall shape of the support frame 20 may be any suitable shape such as a straight cylinder, a disk, a cone, etc., and is not limited herein. The supporting skeleton 20 is provided with at least one blocking member for blocking blood flow, and preferably, the blocking member is a flow blocking film 50. The flow-blocking membrane 50 may be disposed at the distal end and/or the proximal end of the support frame 20; or the flow-blocking membrane 50 may be disposed in the lumen of the support frame 20. The flow-blocking membrane 50 is attached to the support frame 20 by sewing or heat-pressing. The flow blocking film 50 is a PET film or a PTFE film. In this embodiment, the flow-blocking membrane 50 is disposed at the proximal end of the supporting framework 20, and the flow-blocking membrane 50 is sealed at the opening of the left atrial appendage to prevent blood from flowing into the inner cavity of the left atrial appendage.
In this embodiment, in a state where the supporting frame 20 is completely released, the supporting frame 20 includes a cylindrical sealing portion 23, an anchoring portion 25 disposed at a distal end of the sealing portion 23, and a furling portion 26 disposed at a proximal end of the sealing portion 23, the connecting member 72 and the guiding member 70 are disposed at a distal end of the anchoring portion 25, and the outer cable connector 24 is disposed at a proximal end of the furling portion 26. The outer cable connector 24 is used for detachably connecting with an outer cable pipe of the conveying support framework 20. The sealing portion 23 is located at the maximum radial dimension of the supporting frame 20, i.e., the radial dimension of the sealing portion 23 is greater than the radial dimension of the anchoring portion 25 and the radial dimension of the converging portion 26, and the ablating member 40 is disposed on the sealing portion 23. When the supporting framework 20 is implanted into the inner cavity of the left atrial appendage, the sealing part 23 is supported on the inner wall of the left atrial appendage, and the ablation part 40 is attached to the inner surface of the left atrial appendage. The sealing part 23 is formed by a plurality of prismatic frames which surround a circle along the circumference of the supporting framework 20, the near end of the anchoring part 25 is connected with the far end of the sealing part 23, and the far end of the anchoring part 25 is obliquely converged towards the middle part and the far end and then is fixedly connected with the inner steel cable connector 22; the far end of the furled part 26 is connected to the near end of the sealing part 23, and the near end of the furled part 26 is inclined towards the middle part and the near end and then fixedly connected to the outer cable connector 24.
The anchoring portion 25, the gathering portion 26, and the sealing portion 23 constitute a metal-woven or cut net-like structure, a rod-like structure, or a frame structure. Specifically, as shown in fig. 1, the sealing portion 23 is formed by a corrugated annular structure and a plurality of connecting strips 230, the corrugated annular structure is circumferentially arranged and is connected to two circles of gaps, the corrugated annular structure is axially spaced, and the connecting strips 230 are respectively connected to the wave troughs and the corresponding wave crests of the corrugated annular structure. The proximal end of the anchoring portion 25 is connected to the crest of the distal wavy annular structure, and the distal end of the furling portion 26 is connected to the trough of the proximal wavy annular structure. In this embodiment, each ring of the wave-shaped ring structure is formed by sequentially arranging and connecting a plurality of V-shaped supporting rods end to end, each wave-shaped ring structure includes a wave crest 231, a wave trough 233 and wave rods 235, the wave rods 235 adjacent in the circumferential direction are connected at the far end to form the wave crest 231, and the wave rods 235 adjacent in the circumferential direction are connected at the near end to form the wave trough 233. The proximal end of the anchoring portion 25 is connected to the crest 231 of the distal wavy annular structure, and the distal end of the converging portion 26 is connected to the trough 233 of the proximal wavy annular structure. In this embodiment, the ablating member 40 is disposed on the outer wall of the proximal undulating annular structure.
At least one circle of anchoring thorns 252 are arranged on the outer surface of the supporting framework 20 along the circumferential direction, and the anchoring thorns 252 are adjacent to the ablation piece 40 and are turned outwards; preferably, the number of at least one ring of anchoring studs 252 is between 8 and 16. Specifically, a ring of anchors 252 is circumferentially disposed between the sealing portion 23 and the anchoring portion 25 of the support frame 20, each anchor 252 being a hook open toward the proximal end. The outer wall of the supporting framework 20 is provided with the anchoring thorn 252, when the supporting framework 20 is implanted into the inner cavity of the left atrial appendage, the anchoring thorn 252 can penetrate into the inner wall of the left atrial appendage, so that the whole plugging device 100 is anchored in the left atrial appendage without falling off, and meanwhile, the conveyor 60 is convenient to recover.
The outer surface of the supporting framework 20 is provided with at least one circle of developing points or developing wires along the circumferential direction, in this embodiment, a plurality of developing points 232 are arranged on the sealing portion 23 adjacent to the ablation piece 40, the developing points 232 surround the sealing portion 23 into a circle along the circumferential direction, and the developing points 232 are fixed in a manner of embedding and hot pressing. Specifically, one of each two adjacent connecting strips 230 is provided with a visualization point 232 adjacent to one end of the ablating member 40. Preferably, the number of the plurality of development sites 232 is between 8-16.
In other embodiments, one of the wave crest 231, the wave trough 233 and the wave rod 235 of each wave-shaped ring structure is provided with a circle of developing points on the sealing portion 23; or two of the wave crest 231, the wave trough 233 and the wave rod 235 are provided with developing points so as to enclose two circles of spaced developing points on the sealing part 23; or the wave crest 231, the wave trough 233 and the wave rod 235 are all provided with developing points so as to enclose three circles of spaced developing points on the sealing part 23, thereby facilitating the positioning of the sealing part 23 in the inner cavity of the left atrial appendage. The developing point can be made of gold, platinum, tantalum and other materials.
In other embodiments, at least one circle of flexible developing wire is disposed on the sealing portion 23, and the developing wire is fixed by winding, embedding, and hot pressing.
In this embodiment, the ablation energy source is a radio frequency ablation source and the ablating member 40 is configured as an ablation electrode. Specifically, the supporting framework 20 is made of a conductive material, and a part of the supporting framework 20 can be directly used as the ablating part 40, and preferably, one circle of the outer peripheral surface of the supporting framework 20 where the radial dimension is largest is set as the ablating part 40. The ablation part 40 is a part of the surface of the metal supporting framework 20 which is not subjected to insulation treatment, namely at least one circle of the outer peripheral surface of the sealing part 23 is an electrical exposed area; preferably, the outer peripheral surface of the wavy annular structure at the proximal end of the sealing portion 23 is provided as an ablation electrode, i.e., the surface of the supporting frame 20 is insulated except for the outer peripheral surface of the wavy annular structure at the proximal end. Only the metal on the outer peripheral surface of the wave-shaped annular structure at the near end is exposed, so that a circle of continuous wave-shaped ablation electrode can be formed. The outer surface of the supporting framework 20 except the outer peripheral surface of the near-end wave-shaped annular structure is insulated to prevent the other outer surfaces from contacting blood and conducting electricity, so that impedance is reduced, and complete annular ablation on the inner wall of the left atrial appendage cannot be completed. The ablating member 40 may be coupled to an ablation energy source via the outer cable connector 24.
The insulation treatment may be to coat the outer surface of the supporting framework 20 with an insulating coating or to thread an insulating sleeve on the supporting framework. Further, the insulating coating is a parylene insulating coating, and the insulating sleeve can be FEP or ETFE or PFA or PTFE sleeve. Because the support frame 20 is itself electrically conductive, the RF power source can be directly connected through an external lead to deliver RF energy to the ablating member 40 for further concentrating the energy on the tissue against which the ablating member 40 is engaged.
In other embodiments, the supporting frame 20 is a metal cutting supporting frame, and the surface of the supporting frame 20 except the outer surface of the connecting strip 230 is subjected to insulation treatment, so that the outer surface of the connecting strip 230 serves as an ablation piece; or the surface of the supporting framework 20 except the outer surfaces of the connecting strips 230 and the proximal wavy annular structures is subjected to insulation treatment, so that the outer surfaces of the connecting strips 230 and the proximal wavy annular structures are used as ablation pieces.
In other embodiments, the ablating member 40 may be a wire electrode disposed on the sealing portion 23, the wire electrode is electrically connected to the rf power source through an external conducting wire, and in order to concentrate the rf energy on the wire electrode, an insulation treatment, an insulation layer, or an insulation film or an insulation sleeve wrapped around the wire electrode at a position where the wire electrode contacts the sealing portion 23 may be performed.
In other embodiments, the supporting framework 20 may also be a supporting frame made of non-conductive material, and the ablating member 40 is a ring-shaped electrode that is circumferentially disposed at least one continuous or discontinuous turn along the outer surface of the sealing portion 23 of the supporting framework 20; or the ablation part is a plurality of point-like electrodes or strip-like electrodes, and the plurality of point-like electrodes or strip-like electrodes are arranged at least one circle along the circumferential direction of the outer wall surface of the sealing part 23 of the supporting framework 20. In other embodiments, ablating member 40 is a wire electrode disposed in a single or multiple continuous loops along the circumference of support frame 20; the electrode wires are connected to the supporting framework 20 through winding, welding or pressing; and the outer surface of the supporting framework 20 is subjected to insulation treatment in a manner that an insulation coating is coated on the outer surface of the supporting framework 20, or an insulation sleeve is sleeved on the supporting framework 20, or an insulation film is coated on the supporting framework 20. The insulating coating is at least one insulating material selected from FEP, ETFE, PFA and PTFE; the insulating sleeve is at least one insulating tube selected from FEP, ETFE, PFA, PTFE and silica gel; the insulating film is at least one insulating film selected from FEP, ETFE, PFA, PTFE and silicone rubber. The insulating film is connected with the annular framework through sewing, hot pressing, spraying or dipping.
In other embodiments, the source of ablative energy may also be any of microwaves, ultrasound, pulses, cryogens, or chemical ablators.
In other embodiments, the ablating member 40 is disposed in a single or multiple continuous loops along the circumference of the support frame 20. The guide 70 is a curved structure having an axial supporting force and a radial deforming force to slidably fit against the inner wall of the left atrial appendage; alternatively, the guide 70 is a curved structure having a distal end that prevents trauma to the inner wall of the left atrial appendage, and the guide 70 is used to guide the left atrial appendage occlusion device 100 into the left atrial appendage.
In this embodiment, as shown in fig. 1 and 2, the guiding element 70 is disposed at the distal end of the anchoring portion 25, and the supporting frame 20, the connecting element 72 and the guiding element 70 are a cutting stent formed by cutting and shaping a nitinol tube. The guide 70 is a hollow, lattice-cut diamond-like stent that is cut extending from the distal end of the cutting stent. Specifically, the guiding member 70 is a metal laser-cut hollow diamond-like balloon structure, the radial diameter of which is not more than 10mm, and the guiding member can reach the bottom of the left atrial appendage along the inner wall of the left atrial appendage, so that the left atrial appendage occlusion device 100 keeps good centering performance, the left atrial appendage occlusion device 100 is prevented from deviating in the left atrial appendage at a large angle, and anchoring and occlusion of the left atrial appendage occlusion device 100 are stable and ablation can be continuous in a ring shape.
In other embodiments, the guide 70 may be a nickel titanium wire mesh ellipsoid stent, an everted hemispherical metal cutting stent, an inverted drop-shaped metal stent or a diamond-like stent, or the like.
The guide member 70 is pivotally connected to the distal end of the inner cable connector 22 by a link 72, and the link 72 is pivotally movable relative to the axial direction to pivot the guide member 70 relative to the axis of the inner cable connector 22 to facilitate insertion of the guide member 70 along the inner wall of the left atrial appendage into the interior of the left atrial appendage.
The distal end of the connector 72 may be welded, sewn or otherwise attached to the guide 70; or the distal end of the connector is of unitary metal construction with the guide 70; the near end of the connecting piece 72 is welded, sewed or attached to the far end of the supporting framework 20; or the proximal end of the connector may be of unitary metal construction with the support frame 20.
In this embodiment, the connecting member 72 includes two cutting rings with enough space between them to make the connecting member 72 swing in at least 4 or 8 directions, and the proximal end of the connecting member 72 is welded to the distal end of the supporting frame 20 to provide more angle changes between the guiding member 70 and the supporting frame 20, so as to increase the flexibility of the guiding function.
The left atrial appendage occlusion device 100 can be smoothly and quickly implanted into the inner cavity of the left atrial appendage under the guiding action of the flexibly connected guiding piece 70, can be well centered, ensures that the left atrial appendage occlusion device 100 is implanted to a proper position, and enables the ablation piece 40 to be effectively attached to the inner wall of the left atrial appendage so as to achieve the expected annular continuous ablation effect
The distal end of the support framework 20 of the left atrial appendage ablation occlusion device 100 of the present invention is connected to a guide member 70 through a swingable connection member 72, and the guide member 70 can swing with respect to the axis of the support framework 20. Therefore, in the process of implanting the left atrial appendage ablation occlusion device 100 into the inner cavity of the left atrial appendage, the support framework 20 can enter the inner cavity of the left atrial appendage with irregular shape more smoothly under the guiding action of the guiding piece 70, so that the support framework 20 can be stably released to the optimal position, and the implantation efficiency of the left atrial appendage occlusion device 100 is improved. In addition, the inner cable 62 and the outer cable tube 64 of the delivery device 60 are relatively moved in the axial direction by manipulating the delivery device 60 during the operation to adjust the axial dimension and the radial dimension of the support frame 20 so that the ablation member 40 completely fits the inner wall of the left atrial appendage, and at least one complete circle of ablation region can be formed on the inner wall of the left atrial appendage to achieve one complete circle of electrical isolation, thereby treating atrial fibrillation.
Referring to fig. 3 to 5 together, the structure of a left atrial appendage occlusion device 100a provided by a second embodiment of the invention is similar to that of the first embodiment, except that the structure of the guide member 70a of the left atrial appendage occlusion device 100a and the structure of the connecting member 72a between the guide member 70a and the support frame 20 in the second embodiment are different from those in the first embodiment. Specifically, in the second embodiment, the guide 70a is a metal laser-cut hollow balloon stent, and preferably, the inner cable connector 22 and the guide 70a are cut stents formed by cutting and shaping a nitinol tube; the guide 70a is a hollow grid cut spherical stent that is cut extending from the distal end of the cutting stent. The radial diameter of the saccule support is not more than 10mm, and the saccule support can reach the bottom of the left auricle along the inner wall of the left auricle, so that the left auricle plugging device 100a can be quickly and accurately implanted into a proper position in the left auricle, the left auricle plugging device 100a can keep better centering performance, the left auricle plugging device 100a is prevented from deviating in the left auricle at a larger angle, and the anchoring and plugging of the left auricle plugging device 100a are stable and can be in annular continuity in ablation.
In this embodiment, the connection 72a between the guide 70a and the support frame 20 is a hypotube, and the connection 72a can swing in at least two directions, which are opposite in direction. Preferably, the connecting member 72a has at least 2 or 4 directions of oscillation, and the proximal end of the connecting member 72a is welded to the distal end of the support frame 20 to increase the flexibility of the guiding function.
In this embodiment, the proximal end of the connector 72a is provided with an inner cable connector 22, and in particular, the inner wall of the proximal end of the connector 72a is provided with threads for threaded connection with a cable. The left atrial appendage occlusion device 100a in this embodiment needs to be matched with a conveyor 60 when in use, the conveyor 60 comprises an inner steel cable 62 and an outer steel cable tube 64, and the inner steel cable 62 is inserted into the inner cavity of the outer steel cable tube 64; the inner cable 62 is axially movable relative to the outer cable tube 64 and is capable of spinning within the outer cable tube 64. The distal end of the inner cable 62 is detachably connected to the inner cable connector 22, the distal end of the outer cable tube 64 is detachably connected to the outer cable connector 24, and the inner cable 62 and the outer cable tube 64 are axially moved relative to each other, so that the radial dimension of the support frame 20 can be changed. Specifically, the inner cable 62 moves relative to the outer cable tube 64 in the axial direction, and when the inner cable connector 22 and the outer cable connector 24 are close to each other in the axial direction, the axial dimension of the support frame 20 decreases, and the radial dimension increases; when the inner cable connector 22 and the outer cable connector 24 are axially away from each other, the axial dimension of the support frame 20 increases and the radial dimension decreases.
The distal end of the support frame 20 of the left atrial appendage occlusion device 100a of the present invention is connected to the guide 70 by a swingable connection 72a so that the guide 70a can swing with respect to the axis of the support frame 20. Therefore, in the process of implanting the left atrial appendage ablation occlusion device 100a into the inner cavity of the left atrial appendage, the support framework 20 can enter the inner channel of the left atrial appendage with an irregular shape more smoothly under the guiding action of the guiding element 70a, so that the support framework 20 can be stably released to an optimal position, thereby stably occluding and enabling the ablation element 40 to be completely attached to the inner wall of the left atrial appendage, and improving the implantation efficiency of the left atrial appendage occlusion device 100. In addition, since the radial dimension of the supporting framework 20 can be adjusted, the left atrial appendage occlusion device 100a can adjust the dimension of the left atrial appendage occlusion device 100a according to the shape and the opening dimension of the inner channel of the left atrial appendage, thereby conveniently controlling the ablation position of the ablation member 40, so as to form at least one complete circle of ablation region in the inner channel of the left atrial appendage to achieve complete electrical isolation treatment effect.
As shown in fig. 4, in this embodiment, the inner cable connector 22 is connected to the inner cable 62 through a screw structure, and the outer cable connector 24 is connected to the outer cable tube 64 through a screw structure. The far end of the inner steel cable 62 is provided with an external thread matched with the internal thread of the inner steel cable connector 22; the outer cable connector 24 is provided with internal threads, and the distal end of the outer cable tube 64 is provided with external threads which are matched with the internal threads of the outer cable connector 24. Specifically, a connecting hole 221 is formed in the proximal end of the inner steel cable connector 22 along the axial direction, and an internal thread is formed in the inner circumferential surface of the connecting hole 221 of the inner steel cable connector 22; the inner steel cable 62 is a flexible pipe body with a closed far end, the far end of the inner steel cable 62 is provided with a connecting column 621 in a protruding mode along the axial direction, and the outer peripheral surface of the connecting column 621 is provided with an external thread matched with the internal thread of the inner steel cable connector 22. The outer steel cable connector 24 is a hollow pipe body, the inner steel cable 62 is movably inserted into an inner cavity of the outer steel cable connector 24, internal threads are arranged at the near end of the inner peripheral surface of the outer steel cable connector 24, the near end of the furling part 26 is connected to the periphery of the near end of the pipe body, the outer steel cable pipe 64 is a hollow flexible pipe body, and external threads matched with the internal threads of the outer steel cable connector 24 are arranged on the outer peripheral surface of the far end of the outer steel cable pipe 64. The proximal end of the outer cable connector 24 is convex proximally, i.e. the outer cable connector 24 extends proximally in the axial direction.
Referring to fig. 5, after the left atrial appendage ablation occlusion device 100a is released, the axial length of the support frame 20 can be adjusted by pulling the inner wire cable 62 while holding the outer wire cable 64 still, the radial diameter can be increased by shortening the axial distance due to the diamond-shaped nature of the support frame 20 in the form of "water drops" or "Mongolian bags", and the desired radial diameter of the left atrial appendage occlusion device 100 can be adjusted by varying the length of the pulled inner wire cable 62 to enable the ablation member 40 of the left atrial appendage occlusion device 100 to be attached more tightly to the left atrial appendage.
In this embodiment, as shown in fig. 5 and 6, the inner cable 62 is further provided with a perfusion channel 622 along the axial direction, and the outer wall of the inner cable 62 near the proximal end is provided with at least one circle of spraying holes 623 communicating with the perfusion channel 622 along the circumferential direction. Preferably, the outer peripheral wall of the inner cable 62 is axially provided with 1-4 circles of circumferentially and uniformly distributed spray holes 623, and the number of the spray holes 623 is between 4-16. When the inner steel cable 62 is connected to the inner steel cable connector 22, the outer steel cable pipe 64 is connected to the outer steel cable connector 24, the supporting framework 20 is completely released, the spraying holes 623 of the inner steel cable 62 are located in the inner cavity of the supporting framework 20, the spraying holes 623 are opposite to the ablation piece 40, when the ablation piece 40 ablates the left auricle, cooling liquid is sprayed onto the ablation piece 40 or tissues near the ablation piece 40 from the spraying holes 623 after the perfusion channel 622 of the inner steel cable 62, the ablation area of the left auricle can be uniformly cooled, eschar is prevented, and the ablation depth can be increased.
After the ablation of the ablation part 40 is completed in the channel, the left atrial appendage ablation occlusion device 100a enables the support framework 20 to be anchored in the left atrial appendage in a natural state by adjusting the inner steel cable 62 or the outer steel cable pipe 64, releases the connection between the inner steel cable connector 22 and the outer steel cable connector 24 and the inner steel cable 62 and the outer steel cable pipe 64 after confirming that the occlusion is stable, and withdraws the conveyor 60, as shown in fig. 6, only the support framework 20, the connecting part 72a and the guiding part 70a are left in the left atrial appendage to play a role in occluding the orifice of the left atrial appendage and preventing thrombus from falling out.
Referring to fig. 7 and 8, a left atrial appendage occlusion device 100b provided in a third embodiment of the present invention has a structure similar to that of the second embodiment, except that the structure of the guide member 70b and the connection manner of the connection member 72a and the support frame 20 in the third embodiment are different from those in the first embodiment, as follows: the proximal end of the guide 70b of the left atrial appendage closure device 100b is welded to the distal end of the connector 72a, and the proximal end of the connector 72a is welded to the distal end of the inner wire cable 62. The guide 70b is a metal cut, everted hemispherical structure, open towards the proximal end and curled inward. So that the guiding element 70b can penetrate into the bottom of the left atrial appendage without damaging the inner wall of the left atrial appendage, and after the deviation-correcting guiding function is completed, the guiding element 70b and the connecting element 72a can be retracted into the outer steel cable tube 64 under the retraction of the inner steel cable 62, and further can be withdrawn out of the body together with the outer steel cable tube 64.
The connection 72b connects between the guide 70a and the inner cable 62 so that the guide 70a has a certain angular swing, increasing the flexibility of the guiding function.
The left atrial appendage occlusion device 100b of the third embodiment reduces the number of components left in the patient after the procedure is completed, leaving only the support framework 20 to occlude the left atrial appendage cavity, reducing the risk after the procedure.
The other structures of the left atrial appendage occlusion device in the third embodiment are the same as those in the second embodiment, and are not described herein again.
Referring to fig. 9, a fourth embodiment of the present invention provides a left atrial appendage occlusion device having a structure similar to that of the third embodiment, except that the fourth embodiment has a structure in which a guide member 70c and a connecting member 72c are provided; specifically, in the fourth embodiment, the guide 70c is a wire-braided guide ball, and the guide 70c is connected to the inner cable 62 by a connecting member 72 c; preferably, the connector 72c and guide 70c at the distal end of the inner cable 62 are adapted to pass through the inner cable connector and the outer cable connector and to be withdrawn with the inner cable 62. Specifically, the connector 72c is a metal braided tube integrally braided with the guide 70 c. The metal wires are woven into elastic shape memory alloy nickel titanium wires, so that the guide piece 70c and the connecting piece 72c have good flexibility, the guiding function is enhanced, and the implantation balance and stability of the adjustable left atrial appendage occlusion device are improved.
The other structures of the left atrial appendage occlusion device in the fourth embodiment are the same as those in the third embodiment, and are not described herein again.
Referring to fig. 10, a left atrial appendage occlusion device 100c according to a fifth embodiment of the present invention has a structure similar to that of the second embodiment, except that a structure of a support frame 20a in the fifth embodiment is different from that of the second embodiment, as follows: the proximal end of the supporting framework 20a is a metal cutting stent in a shape of a 'straw hat', and the distal end is a hollow saccule stent, which are connected by a connecting piece 72 a. The support framework 20a comprises an anchoring portion 25a located at the far end, a sealing portion 23a located at the near end and an ablation portion 27 located between the anchoring portion 25a and the sealing portion 23a, an inner steel cable connector 22 is arranged at the far end of the anchoring portion 25a, an outer steel cable connector 24 is arranged at the near end of the sealing portion 23a, the inner steel cable connector 22 is detachably connected with the far end of an inner steel cable, and the outer steel cable connector 24 is detachably connected with an outer steel cable pipe.
The supporting framework 20a of the straw hat type is divided into a cone frame from the far end to the near end, a truncated cone frame and a circle of flanges form a hat brim which protrudes outwards.
The anchoring portion 25a includes the cone frame, the truncated cone frame, and 8-16 everted anchors 252 uniformly arranged in the circumferential direction at the outer distal end of the truncated cone frame. The anchor 252 enables the entire left atrial appendage closure device 100c to fit tightly within the left atrial appendage without falling off, while facilitating the retrieval of the inner and outer steel cables. The distal end of anchor portion 25a is towards the middle part and is buckled to the near-end for the distal end of interior steel cable connector 22 is the turn-up structure, thereby the distal end of support skeleton 20a that can avoid is sharp-pointed gradually, in order to prevent that sharp-pointed distal end from stabbing left atrial appendage inner wall, has also reduced simultaneously the whole height of left atrial appendage ablation plugging device 100 a.
The ablation piece 40 is arranged on a flange at the position of a hat brim at the far end of the straw hat-shaped metal cutting support, can be tightly attached to an ablation area on the inner wall of the auricle, and improves the ablation effect. In this embodiment, the ablating member 40 is a bare metal frame on the support frame 20a that can be connected to a radio frequency power source. The support framework 20a is used as the outer surface of the metal outside the metal frame of the ablation piece 40 for insulation treatment, and the insulation treatment mode comprises coating an insulation coating, coating an insulation film or inserting an insulation sleeve.
Referring to fig. 11, a left atrial appendage occlusion device 100d according to a sixth embodiment of the present invention has a structure similar to that of the first embodiment, except that the structures of the supporting framework 20b and the connecting member 72d in the sixth embodiment are different from those of the first embodiment, as follows: support chassis 20b is the elastic metal wire woven frame of cylinder type, the distal end of metal woven frame is provided with the guide piece 70 that is formed by nickel titanium alloy tubular product cutting design, and guide piece 70 is hollow class diamond-shaped support, the near-end of guide piece 70 with connect through connecting piece 72d between the distal end middle part of metal woven frame, the near-end welding of connecting piece 72d the distal end of metal woven frame.
The supporting framework 20b is a hollow structure, and comprises an anchoring part 25b at the far end, a sealing part 23b at the near end, and an ablation part 27 connected between the anchoring part 25b and the sealing part 23b, wherein the ablation part 27 is arranged at the position where the radial dimension of the anchoring part 25b and/or the sealing part 23a is maximum, and the ablation part 40 is arranged on the outer peripheral surface of the ablation part 27 for at least one circle. The distal end of anchor portion 25b is equipped with interior steel cable connector 22, and the near-end of sealing 23b is equipped with outer steel cable connector 24, and interior steel cable connector 22 can be dismantled with the distal end of interior steel cable and be connected, and outer steel cable connector 24 can be dismantled with outer steel cable pipe and be connected. The connecting piece 72d comprises a nickel titanium pipe with laser cutting buckle patterns, and can swing in a staggered manner in multiple directions, such as front, back, left, right, up and down, so that the flexibility of the guiding function is improved. The connecting piece 72d can deflect relative to the metal woven frame and the guide piece, so that the left atrial appendage occlusion device 100d can enter the left atrial appendage with an irregular shape more smoothly, and the implantation efficiency of the left atrial appendage occlusion device 100d is improved.
The anchor portion 25b, the ablation portion 27 and the sealing portion 23b have the same diameter, and the whole device has a cylindrical structure. The support framework 20b in the embodiment is integrally formed by weaving metal wires into three parts of an integral structure of an anchoring part 25b, an ablation part 27 and a sealing part 23b and then shaping, and an outer steel cable connector 24 arranged on the sealing part 23b is tied at the near end; the distal end of the anchor portion 25b is beam welded to the connection 72 d. The braided metal wire of the present embodiment may be nickel-titanium alloy, cobalt-chromium alloy, stainless steel, or other metal material with good biocompatibility. The super-elastic shape memory alloy nickel-titanium wire is preferably selected, and the manufacturing process is the same as that of the traditional left atrial appendage occluder, and the details are not repeated here. In addition to the above-mentioned integral structure, the anchoring portion 25b, the ablation portion 27, and the sealing portion 23b may be directly fixed together by welding or the like.
The anchoring portion 25b comprises the distal frame itself, two layers of the flow-blocking membrane 50, the anchoring thorn 252; the periphery of the choke membrane 50 is fixed inside the anchor portion 25b by sewing, and the choke membrane 50 is, for example, a PET or PTFE film. The anchoring thorns 252 are uniformly arranged on the outer wall of the cylindrical structure in a circle, and each anchoring thorn 252 extends towards the outer direction of the proximal end or is of a folded structure. The metal mesh skeleton of the anchor portion 25b is coated with an insulating coating (not shown) at least on the outer wall surface that is in contact with the left atrial appendage; the coating can be fixed on the metal framework of the anchoring part by coating, and an insulating sleeve, such as FEP or ETFE or PFA or PTFE sleeve, can be used to sleeve the insulating sleeve outside each metal wire.
The ablation part 40 is positioned in the area between the ablation part 27 and the sealing part 23b, and the ablation part 40 is provided with at least one circle of metal annular framework along the circumferential direction of the metal grid framework. Preferably, the metal annular framework is connected with an ablation energy source, and the annular outer wall surface of the metal annular framework is a conductive ablation surface. The surface of the ablation surface is not insulated and is a bare metal structure.
In other embodiments, the supporting frame 20 is insulated except for the ablation portion 27, and the ablation part 40 is a portion of the metal cutting stent that is not insulated, i.e. at least one circle of electrically exposed region on the outer circumferential surface of the ablation portion 27.
The sealing part 23b is positioned at the proximal end of the metal woven frame and is matched with the neck part of the left auricle in shape; in this embodiment, the sealing portion 23b is fitted into the neck portion of the left atrial appendage, and the diameter of the sealing portion 23b matches the inner diameter of the neck portion of the left atrial appendage. The metal grid framework of the sealing part 23b is coated with an insulating coating (not shown in the figure) at least on a sealing surface jointed with the left auricle, the insulating coating is one or more layers of insulating materials formed on the metal grid framework by adopting an insulating material coating mode, and the metal grid framework is isolated from being contacted with the left auricle for conducting electricity; the insulation of the sealing portion 23b may also be applied by means of an insulating sleeve over each wire of the metal grid skeleton. The sealing of the sealing portion 23b is performed by a flow blocking film 50 provided inside thereof, and the periphery of the flow blocking film 50 is fixed inside the sealing portion by sewing, for example, a PET or PTFE film.
Referring to fig. 12, a left atrial appendage occlusion device 100e according to a seventh embodiment of the present invention has a structure similar to that of the sixth embodiment, except that the structure of the guide member 70c and the structure of the connecting member 72c in the seventh embodiment are different from those in the sixth embodiment, as follows: the guide member 70c and the connecting member 72c of the seventh embodiment are of a wire integrally woven structure and can be connected to the distal end of the metal woven frame by welding, steel sleeve or integrally woven. The metal wire is an elastic shape memory alloy nickel titanium wire, so that the guide piece 70c and the connecting piece 72c have good flexibility and the guiding function is enhanced.
In other embodiments, the guide member, the connector member, and the support frame are woven as a unitary structure from wires.
In other embodiments, the connecting member may also be a spring, a coil, or an elastic rubber rod, etc.
The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.
Claims (18)
1. The utility model provides a plugging device is ablated to left auricle, its including the support chassis and set up in the piece that melts of support chassis outer peripheral face, its characterized in that, the distal end of support chassis sets up the guide piece, the distal end of support chassis with be equipped with the connecting piece between the guide piece, the connecting piece can for the axial lead swing of support chassis, through the guide piece drives the connecting piece is crooked, until it laminates to melt the piece the suitable position of the inner wall of left auricle, melt the piece and melt the energy and be connected, it melts the inner wall of left auricle and annularly to melt the piece.
2. The left atrial appendage ablation occlusion device of claim 1, wherein the guide is a curved structure having an axial support force and a radial deformation force to conform to an inner wall of the left atrial appendage; or the guide is a curved structure with a distal end for preventing trauma to the inner wall of the left atrial appendage, and the guide is used for guiding the left atrial appendage occlusion device into the left atrial appendage.
3. The left atrial appendage ablation occlusion device of claim 2, wherein the guide is a hollow mesh cutting spherical stent, a nickel titanium wire mesh grid ellipsoid stent, an everted hemispherical metal cutting stent, an inverted drop-shaped metal stent or a diamond-like stent.
4. The ablation occlusion device of claim 1, wherein the distal end of the connector is welded, sewn or otherwise attached to the guide member; or the distal end of the connector and the guide are of a unitary metal construction.
5. The ablation occlusion device of claim 1, wherein the proximal end of the connector is welded, sewn or otherwise attached to the support frame; or the near end of the connecting piece and the supporting framework are of an integral metal structure.
6. The ablation occlusion device of claim 1, wherein the connector is in the form of a rotating shaft structure, a circular buckle structure, a universal joint structure, a snap structure, or a ball bearing structure.
7. The ablation occlusion device of claim 1, wherein the connector can be a spring, a hypotube, a helical tube, an elastic wire braided structure, or an elastic rubber rod.
8. The left atrial appendage ablation occlusion device of claim 1, wherein the connector is a wire woven wire structure integrally woven with the guide member with a wire and/or integrally woven with the support armature wire.
9. The ablation occlusion device of claim 1, wherein the support frame comprises an anchoring portion at a distal end and a sealing portion at a proximal end, wherein the anchoring portion and the sealing portion are formed of a metal braided or cut mesh, rod, or frame structure.
10. The left atrial appendage ablation occlusion device of claim 9, wherein the support framework further comprises an ablation portion disposed at a maximum radial dimension of the anchoring portion and/or the sealing portion, and the ablation member is disposed on an outer peripheral surface of the ablation portion for at least one turn.
11. The ablation occlusion device of claim 10, wherein the ablating member delivers an ablative energy source to the left atrial appendage for ablating the inner wall of the left atrial appendage in a ring-like pattern, the ablative energy source being one of a radio frequency, microwave, ultrasound, pulse, cryogen, or chemical ablative agent.
12. The ablation occlusion device of claim 1, wherein the outer surface of the supporting framework is circumferentially provided with at least one ring of anchoring thorns, each anchoring thorn extending in a proximal-to-distal direction or being of a folded structure.
13. The left atrial appendage ablation occlusion device of claim 1, wherein the outer surface of the support framework is circumferentially provided with at least one ring of visualization points or visualization filaments.
14. The left atrial appendage ablation occlusion device of claim 1, wherein the proximal end of the support frame is provided with an outer cable connector for detachably connecting to an outer cable tube.
15. The left atrial appendage ablation and occlusion device of claim 14, wherein an inner cable connector is disposed at the junction of the support framework and the connector, the inner cable connector is configured to detachably connect with an inner cable, the inner cable is inserted into the inner cavity of the outer cable tube, and the inner cable is axially movable and rotatable with respect to the outer cable tube.
16. The left atrial appendage ablation occlusion device of claim 15, wherein the inner cable connector is connected to the inner cable by a threaded structure; the outer steel cable pipe is connected with the outer steel cable connector through a threaded structure.
17. The left atrial appendage ablation occlusion device of claim 16, wherein the inner cable moves axially relative to the outer cable tube to move the inner cable connector and the outer cable connector relatively closer together or further apart to change a radial dimension of the support frame.
18. The left atrial appendage ablation occlusion device of claim 17, wherein the inner cable connector and the outer cable connector are relatively close together, the support frame decreasing in axial dimension and increasing in radial dimension; interior steel cable connector with outer steel cable connector keeps away from relatively, the axial dimension increase and the radial dimension of support chassis diminishes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911426001.1A CN113116447A (en) | 2019-12-31 | 2019-12-31 | Left auricle ablation plugging device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911426001.1A CN113116447A (en) | 2019-12-31 | 2019-12-31 | Left auricle ablation plugging device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113116447A true CN113116447A (en) | 2021-07-16 |
Family
ID=76771545
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201911426001.1A Pending CN113116447A (en) | 2019-12-31 | 2019-12-31 | Left auricle ablation plugging device |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113116447A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023208002A1 (en) * | 2022-04-28 | 2023-11-02 | 杭州德诺电生理医疗科技有限公司 | Delivery device and medical instrument system |
-
2019
- 2019-12-31 CN CN201911426001.1A patent/CN113116447A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023208002A1 (en) * | 2022-04-28 | 2023-11-02 | 杭州德诺电生理医疗科技有限公司 | Delivery device and medical instrument system |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US20220110679A1 (en) | Atrial septostomy device | |
| US20200289196A1 (en) | Transcatheter device for interatrial anastomosis | |
| WO2019085841A1 (en) | Atrial septostomy device, atrial septostomy system, operating method for same, and opening-creation method | |
| CN212346704U (en) | Improved left auricle plugging device | |
| JP2010540198A (en) | System and method for transseptal heart treatment | |
| WO2020094087A1 (en) | Atrial septostomy device with improved ablation method and atrial septostomy system | |
| WO2020094085A1 (en) | Atrial septostomy device and atrial septostomy system having improved ablation effect | |
| CN215129380U (en) | Left auricle plugging device | |
| CN110215253A (en) | Left atrial appendage occlusion ablating device | |
| CN112754650A (en) | Heart interatrial septum shunt system with improved safety | |
| CN111166461A (en) | Interatrial septum stoma device and interatrial septum stoma system thereof | |
| CN212165887U (en) | Heart interatrial septum shunt system | |
| CN111166463A (en) | Interatrial septum ostomy device with improved ablation mode and interatrial septum ostomy system | |
| CN113116448A (en) | Improve left auricle of heart and melt plugging device of security | |
| CN111166462A (en) | Interatrial septum stoma device and interatrial septum stoma system with improved ablation effect | |
| CN212346621U (en) | Left auricle ablation plugging device | |
| CN212346703U (en) | Adjustable interatrial septum ostomy device | |
| CN111150483A (en) | Ablation plugging device | |
| JP7515568B2 (en) | HEART ANNULOPLASTY AND PACING PROCEDURES, ASSOCIATED DEVICES AND METHODS | |
| CN113116447A (en) | Left auricle ablation plugging device | |
| CN111329576A (en) | Ablation plugging device, ablation plugging conveying device and ablation plugging system | |
| CN211934176U (en) | Improve left auricle of heart and melt plugging device of security | |
| CN112754651A (en) | Heart interatrial septum shunt system | |
| WO2023125866A1 (en) | Ablation and occlusion system | |
| WO2019166017A1 (en) | Left atrial appendage occlusion and ablation device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20230512 Address after: Room 127, 1st Floor, Building 3, No. 96, Longchuanwu Road, Donghu Street, Linping District, Hangzhou City, Zhejiang Province, 311106 Applicant after: Hangzhou DeNO electrophysiological Medical Technology Co.,Ltd. Address before: 310051 301-014, 3rd floor, building 2, 88 Jiangling Road, Binjiang District, Hangzhou City, Zhejiang Province Applicant before: Hangzhou nori Medical Technology Co.,Ltd. |
|
| TA01 | Transfer of patent application right |