CN116509468B - Plugging system and knotting method of tightening piece - Google Patents
Plugging system and knotting method of tightening piece Download PDFInfo
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- CN116509468B CN116509468B CN202310235543.0A CN202310235543A CN116509468B CN 116509468 B CN116509468 B CN 116509468B CN 202310235543 A CN202310235543 A CN 202310235543A CN 116509468 B CN116509468 B CN 116509468B
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- 238000000034 method Methods 0.000 title claims abstract description 25
- 230000007547 defect Effects 0.000 claims abstract description 29
- 230000003014 reinforcing effect Effects 0.000 claims description 27
- 238000007789 sealing Methods 0.000 claims description 24
- 238000004804 winding Methods 0.000 claims description 13
- 210000005166 vasculature Anatomy 0.000 claims description 3
- 230000002792 vascular Effects 0.000 abstract description 2
- 230000002787 reinforcement Effects 0.000 description 51
- 230000008569 process Effects 0.000 description 14
- 210000004491 foramen ovale Anatomy 0.000 description 9
- 238000010276 construction Methods 0.000 description 8
- 229910001000 nickel titanium Inorganic materials 0.000 description 8
- 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 5
- 229920000291 Poly(9,9-dioctylfluorene) Polymers 0.000 description 4
- 230000000903 blocking effect Effects 0.000 description 4
- 210000005246 left atrium Anatomy 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 230000007246 mechanism Effects 0.000 description 4
- 210000003157 atrial septum Anatomy 0.000 description 3
- 210000002837 heart atrium Anatomy 0.000 description 3
- -1 polytetrafluoroethylene Polymers 0.000 description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 description 3
- 210000005245 right atrium Anatomy 0.000 description 3
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 2
- 210000003484 anatomy Anatomy 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000008094 contradictory effect Effects 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
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- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 description 1
- 208000035478 Interatrial communication Diseases 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 208000008883 Patent Foramen Ovale Diseases 0.000 description 1
- 229920000954 Polyglycolide Polymers 0.000 description 1
- 208000001910 Ventricular Heart Septal Defects Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 208000013914 atrial heart septal defect Diseases 0.000 description 1
- 206010003664 atrial septal defect Diseases 0.000 description 1
- 230000004323 axial length Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 238000009954 braiding Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 230000003750 conditioning effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 239000010410 layer Substances 0.000 description 1
- 210000001161 mammalian embryo Anatomy 0.000 description 1
- 238000002324 minimally invasive surgery Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 229920000747 poly(lactic acid) Polymers 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 239000004626 polylactic acid Substances 0.000 description 1
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- 238000006467 substitution reaction Methods 0.000 description 1
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00619—Locking means for locking the implement in expanded state
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
The embodiment of the application provides a plugging system and a knotting method of a tightening member, which relate to the field of interventional medical equipment, wherein the plugging system is used for plugging defects in a vascular system and comprises the following components: a first occlusion disk and a second occlusion disk for covering different openings of the defect; the tightening member comprises an adjusting wire loop, an adjusting section, a locking section and a knot, wherein the adjusting section and the locking section are connected to the proximal side of the knot, and the adjusting wire loop is connected to the distal side of the knot; the knot comprises at least one loop, the adjusting section passing through the knot and adjusting at least two of the loops; the locking section is used for driving the wire ring in the wire knot to shrink, and the wire knot locks the end part of the adjusting section.
Description
Technical Field
The application relates to the field of interventional medical equipment, in particular to a plugging system and a knotting method of a tightening member.
Background
The foramen ovale is an open area in the middle of the left and right atrial septum and is positioned at the junction of the primary septum and the secondary septum of the embryo. The foramen ovale is typically covered by a sheet of primary space. Before birth, the foramen ovale is continuously open because blood flow is from right to left. After birth, normal pulmonary circulation is established, forcing the thin sheet of the primary atrial septum to press against the surface of the foramen ovale, gradually forming a permanent atrial septum, due to the increase in pressure in the atrium. However, if the fusion is not complete over 3 years old, the remaining fissure-like channels are called PFOs, which range in length from 3 to 18mm and increase with age. To occlude the foramen ovale, PFO occlusion systems were invented.
The existing PFO plugging system comprises a first plugging disc and a second plugging disc, wherein the first plugging disc is connected with the second plugging disc through a wire ring, and two ends of the wire ring are fixed together through a wire knot. In some cases, since the two ends of the wire loop are not tied firmly enough, the wire knot on the wire loop is easy to loose, the first blocking disc and the second blocking piece are separated from the wire body, and the safety of the instrument cannot be guaranteed.
Disclosure of Invention
In view of the above-mentioned shortcomings of the prior art, the present application aims to provide a tying method for a plugging system and a tightening member, which improves the knot firmness in the plugging system and ensures the safety of the plugging system.
In order to achieve the above purpose, the following technical solutions are adopted in the embodiments of the present application:
an occlusion system for occluding a defect in a vasculature, comprising: a first occlusion disk and a second occlusion disk for covering different openings of the defect; the tightening member comprises an adjusting wire loop, an adjusting section, a locking section and a knot, wherein the adjusting section and the locking section are connected to the proximal side of the knot, the adjusting wire loop is connected to the distal side of the knot, the adjusting section, the locking section and the knot are arranged on one side of the second plugging disc, which is away from the first plugging disc, a part of the adjusting wire loop is connected between the first plugging disc and the second plugging disc, and the adjusting wire loop is used for being penetrated in the defect; the knot comprises at least one loop of wire, the adjustment section passing through the knot and at least two of the adjustment loops of wire; the locking section is used for driving the wire loop in the wire knot to shrink, and the wire knot locks the end part of the adjusting section.
A method of tying a fastener in a closure system as described above, comprising the steps of:
the knot is formed by winding a wire, and the adjustment wire loop is connected distal to the knot, the wire forming two sections including ends proximal to the knot, the adjustment section and the locking section, respectively.
The beneficial effects are that: the plugging system provided by the embodiment of the application comprises a first plugging disc, a second plugging disc and a tightening member for connecting the first plugging disc and the second plugging disc, wherein the tightening member comprises an adjusting wire loop, an adjusting section, a locking section and a wire knot, the adjusting section and the locking section are connected to the near side of the wire knot, the adjusting wire loop is connected to the far side of the wire knot, the adjusting section, the locking section and the wire knot are arranged on one side of the second plugging disc, which is far away from the first plugging disc, a part of the adjusting wire loop is connected between the first plugging disc and the second plugging disc, the locking section is pulled to enable the locking section to drive the wire loop in the wire knot to shrink, and the wire knot locks the end part of the adjusting section.
Drawings
Fig. 1 is a schematic view of the structure of a plugging system according to an embodiment of the present application.
FIG. 2 is a schematic illustration of one configuration of a tension member according to one embodiment of the present application.
FIG. 3 is a schematic view of another construction of a tension member according to a first embodiment of the present application.
FIG. 4 is a schematic illustration of another construction of a tension member according to a first embodiment of the present application.
FIG. 5 is a schematic view of another construction of a tension member according to a first embodiment of the present application.
FIG. 6 is a schematic illustration of another configuration of a tension member provided in accordance with a first embodiment of the present application.
FIG. 7 is a schematic illustration of another construction of a tension member according to a first embodiment of the present application.
FIG. 8 is a schematic illustration of another construction of a tension member according to a first embodiment of the present application.
FIG. 9 is a schematic illustration of one configuration of a fastener according to a second embodiment of the present application.
FIG. 10 is a schematic illustration of another construction of a tension member according to a second embodiment of the present application.
FIG. 11 is a schematic illustration of another construction of a tension member according to a second embodiment of the present application.
FIG. 12 is a schematic illustration of another construction of a tension member according to a second embodiment of the present application.
FIG. 13 is a schematic view of a tightening member according to a third embodiment of the present application.
FIG. 14 is a schematic view of a fourth embodiment of the present application.
Description of main reference numerals: 1-a first plugging disc; 2-a second plugging disc; 3-a tightening member; 31-adjusting the wire loop; 32-adjusting the segments; 33-locking section; 34-knot; 341-a base wire loop; 342-locking the wire loop; 343-a first connection section; 344-a second connection section; 345-reinforcing the wire loop; 346-locking space; 4-a conveying device; 41-a handle; 42-nickel titanium tube.
Detailed Description
The embodiment of the application provides a plugging system and a knotting method of a tightening member, and the application is further described in detail below with reference to the accompanying drawings and examples in order to make the purposes, the technical scheme and the effects of the application clearer and more definite. It should be understood that the detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the application.
It should be noted that, in the interventional medical field, along the transport path of the instrument, the end/side of the instrument that is closer to the operator is generally referred to as the proximal end/side, and the end/side of the instrument that is farther from the operator is generally referred to as the distal end/side. For a delivery device for delivering and releasing an implantable device into a patient, distal end/side refers to the end/side of the delivery device that is freely insertable into an animal or living being, and proximal end/side refers to the end/side of the delivery device for user or machine operation.
The plugging system provided by the embodiment of the application is used for plugging defects in vascular systems, including but not limited to, foramen ovale, arterial catheter, atrial septal defect, ventricular septal defect and the like, and the advantages of the plugging system for treating patent foramen ovale are described by taking the defects as examples, and the defects can be other defects.
Referring to fig. 1, the occlusion system comprises a first occlusion disc 1, a second occlusion disc 2, a tightening member 3 and a delivery device 4, the first occlusion disc 1 and the second occlusion disc 2 being arranged to cover different openings of said defect, the tightening member 3 being arranged to pass through said defect and to connect the first occlusion disc 1 and the second occlusion disc 2. After the plugging system is implanted into organisms, the first plugging disc 1 and the second plugging disc 2 are covered on different openings of the defect, and the distance between the first plugging disc 1 and the second plugging disc 2 is locked by the tightening member 3, so that the plugging system can plug the defect.
That is, after the plugging system is implanted into an organism, the first plugging disc 1 and the second plugging disc 2 are respectively covered at different openings of the defect, in this embodiment, as shown in fig. 1, the first plugging disc 1 and the second plugging disc 2 are respectively covered at two sides of the defect, that is, the first plugging disc 1 and the second plugging disc 2 are respectively covered at the primary space and the area adjacent to the foramen ovale, the first plugging disc 1 is used for being released at the left atrium for plugging the opening of the defect facing the left atrium, and the second plugging disc 2 is used for being released at the right atrium for plugging the opening of the defect facing the right atrium. The tightening means 3 passes through the defect and can thus be connected to both the first and second closure disc 1, 2. After the tightening piece 3 is tightened, the first blocking disc 1 and the second blocking disc 2 are respectively stuck to the circumferences of two sides of the defect, so that the defect is blocked; moreover, the occlusion system is secured in place at the defect occluding the vasculature.
Referring to fig. 2, the tightening member 3 is formed of a wire member, has flexibility, and may be made of a degradable material or a non-degradable material. The material of the tightening member 3 includes, but is not limited to, at least one of polytetrafluoroethylene, polyglycolide, polylactic acid, collagen, nylon suture, polyester suture. Preferably, the tightening member 3 is a suture made of polytetrafluoroethylene. The mechanical strength of the polytetrafluoroethylene material is high, so that the toughness of the tightening member 3 is improved.
The cinch 3 includes an adjustment wire loop 31, an adjustment segment 32, a locking segment 33, and a knot 34. The adjustment section 32 and the locking section 33 each comprise an end which is also the end of the tightening member 3, the ends of the adjustment section 32 and the locking section 33 being connected to the proximal side of the knot 34 for extending proximally of the knot 34 and thereby connecting the delivery device 4 (as shown in fig. 1). The adjustment wire loop 31 is connected to the distal side of the knot 34, and the adjustment section 32, the locking section 33 and the knot 34 are located proximal to the second occlusion disc 2. The adjusting wire ring 31 is in a U-shape ring shape, both ends of the adjusting wire ring 31 are connected to the wire knot 34 and located at the proximal side of the second sealing disk 2, and a portion between both ends of the adjusting wire ring 31 extends in the distal direction of both ends thereof with respect to both ends thereof and connects the first sealing disk 1 and the second sealing disk 2. Specifically, a portion between both ends of the adjustment wire loop 31 passes through the second occlusion disk 2 and extends distally and connects the first occlusion disk 1, and a portion of the adjustment wire loop 31 is connected between the first occlusion disk 1 and the second occlusion disk 2. After implantation of the occlusion system in a living being, the portion of the adjustment wire loop 31 between the first occlusion disc 1 and the second occlusion disc 2 passes through the defect. Wherein, one side of the second plugging disc 2 deviating from the first plugging disc 1 is the proximal side of the second plugging disc 2 and the first plugging disc 1, one side of the first plugging disc 1 deviating from the second plugging disc 2 is the distal side of the first plugging disc 1 and the second plugging disc 2, one side of the first plugging disc 1 and the second plugging disc 2 facing each other is the proximal side of the first plugging disc 1, and the distal side of the second plugging disc 2.
The knot 34 is a slip knot, in the process of assembling the tightening member 3 with the first plugging disc 1 and the second plugging disc 2, one end of the adjusting wire loop 31 is connected to the knot 34, the other end of the adjusting wire loop 31 is connected to the adjusting section 32, the end of the adjusting section 32 passes through the second plugging disc 2, is connected with the first plugging disc 1, passes through the second plugging disc 2 again and then passes through the knot 34, and the adjusting section 32 passes out from the proximal side of the knot 34.
When the knot 34 is not tensioned, the adjusting section 32 can drive one end of the adjusting wire loop 31 connected with the knot 32 to slide into the knot 34 and slide out from the proximal side of the knot 34, so that the axial length of the adjusting wire loop 31 is shortened, the length of the adjusting section 32 is increased, namely, a part of sections in the adjusting wire loop 31 are converted into the adjusting section 32, and the length of the adjusting wire loop 31 between the first plugging disc 1 and the second plugging disc 2 is adjusted; pulling on the locking section 33 may tighten the knot 34 such that the knot 34 tightens a portion of the adjustment loop 31 located therein to fix the length of the adjustment loop 31 between the first occlusion disk 1 and the second occlusion disk 2.
In the above, the length of the linear member between the first sealing disc 1 and the second sealing disc 2 is adjusted by pulling the adjusting section 32, so as to control the distance between the first sealing disc 1 and the second sealing disc 2, so as to adapt to the anatomical structure of the patient, and be favorable to improving the fitting degree of the tissues of the peripheral edges of the first sealing disc 1, the second sealing disc 2 and the oval foramen, thereby stably sealing the oval foramen.
After the first plugging disc 1 and the second plugging disc 2 are released respectively, the distance between the first plugging disc 1 and the second plugging disc 2 is adjusted, so that the deformation degree of the primary interval and the secondary interval after the instrument is implanted is ensured to be smaller, the endothelialization of the two diaphragms to the plugging discs is not influenced, the generation of residual shunt is reduced, the trouble that the plugging device is required to be customized due to the specificity of the oval hole structure of individual patients is avoided, the application range of the PFO plugging device is effectively widened, and more patients benefit from the minimally invasive surgery.
In embodiments where there are more than 2 openings in the defect, the occluding device is also used to occlude multiple openings in the defect on different sides or on the same side.
As shown in fig. 1, at least two holes for passing through the tightening member 3 are formed in the second sealing disc 2, the tightening member 3 passes through one of the holes on the second sealing disc 2 and is connected with the first sealing disc 1, and then passes through the other hole on the second sealing disc 2, so that the tightening member 3 is connected with the first sealing disc 1 and the second sealing disc 2, two ends of the tightening member 3 are located at one side (proximal side) of the second sealing disc 2 away from the first sealing disc 1, and an adjusting wire loop 31 in a U shape is formed at the distal end of the wire knot 34, and the opening of the adjusting wire loop 31 in the U shape faces the wire knot 34.
As shown in fig. 2-14, the knot 34 comprises at least one thread loop, the adjusting section 32 passes through the knot 34 and at least two thread loops of the adjusting thread loops 31, the end of the adjusting section 32 is connected with the end of the adjusting thread loop 31, and when the adjusting section 32 is pulled, the end of the adjusting thread loop 31 can be driven to move proximally through the knot 34, so as to adjust the distance between the first plugging disc 1 and the second plugging disc 2. The locking section 33 is connected to the wire loop of the knot 34, and the locking section 33 is used for driving the wire loop in the knot 34 to shrink, i.e. when the locking section 33 is pulled (by an operator or a conveying device), the locking section 33 can drive the wire loop of the knot 34 to shrink, so that the knot 34 locks the end of the adjusting section 32. After the knot 34 locks the adjustment section 32, the distance between the first and second closure discs 1, 2 is locked.
Briefly, the wire used to make the tightening element 3 is surrounded by a plurality of loops, the section between one end of the wire and the loop being the locking section 33; after the other end passes through the first occlusion disk 1, the second occlusion disk 2 and the wire loop of the knot 34, it passes out from the proximal side of the knot 34, wherein the section located at the proximal side of the knot 34 is the adjusting section 32, and the section located at the distal side of the knot 34 encloses the adjusting wire loop 31. Thus, pulling on the adjustment section 32 can bring the end (in particular one end) of the adjustment wire loop 31 proximally of the knot 34, enabling adjustment of the distance between the first occlusion disc 1 and the second occlusion disc 2.
In the present application, the adjustment segment 32 passes through the knot 34 and at least two of the adjustment loops 31, which in some embodiments are at least two of the knot 34, and in some embodiments include at least one of the knot 34 and the adjustment loop 31 outside of the knot 34. After the locking section 33 is pulled to shrink the plurality of wire loops (including the wire loops in the wire knot 34 and the adjusting wire loop 31 outside the wire knot 34), the adjusting section 32 or the end part of the adjusting section 32 can be locked by at least two wire loops in the wire knot 34, or at least one wire loop in the adjusting wire loop 31 and the wire knot 34, at least two wire loops are provided to lock the adjusting section 32, the number of wire loops used for locking the adjusting section 32 is increased, the locking is firmer, and the wire knot 34 is not easy to loosen because of the movement of the first plugging disc 1 and the second plugging disc 2 or the conveying device 4 pulls the adjusting section 32 and the locking section 33, so that the locking capability of the tightening member 3 on the adjusting section 32 and the locking performance of the distance between the first plugging disc 1 and the second plugging disc 2 are improved, and the safety and reliability of the plugging system are further ensured.
For the plugging system with the preset length of the adjusting wire ring 31, the distance between the first plugging disc 1 and the second plugging disc 2 is not required to be adjusted, and the locking of the adjusting section 32 can be realized by pulling the locking section 33. I.e. having a set locking position on the adjustment section 32, the knot 34 is located in the set locking position, and the closure system, after release, can lock the adjustment section 32 by pulling on the locking section 33.
In the plugging system of the present application, the wire knot 34 may pull the locking section 33 during the assembly process, so that the wire loop of the wire knot 34 locks the adjusting section 32, so that the first plugging disc 1, the second plugging disc 2 and the tightening member 3 are integrated, and the first plugging disc 1 and the second plugging disc 2 are prevented from being separated from the adjusting wire loop 31. In the process of releasing the plugging system into the living body, the whole formed by the first plugging disc 1, the second plugging disc 2 and the tightening piece 3 is directly released into the living body.
The plugging system of the application can also adjust the distance between the first plugging disc 1 and the second plugging disc 2 according to the anatomical structure of the living body in the process of releasing the plugging system in the living body, and then the length of the adjusting wire loop 31 between the first plugging disc 1 and the second plugging disc 2 is fixed by pulling the locking section 33 to lock the wire loop of the wire knot 34 to the adjusting section 32. In the description herein, this is described by way of example.
The proximal end of the locking segment 33 is connected to the delivery device 4, and the locking segment 33 can be pulled by the delivery device 4, causing the wire loop of the knot 4 to contract to lock the adjustment segment 32.
In an embodiment, the proximal end of the adjusting section 32 is also connected to the delivery device 4, and when the wire loop of the knot is in an untruncated state, the adjusting section can be pulled by the delivery device 4 to drive the adjusting wire loop to pass through the knot, so as to adjust the distance between the first plugging disc 1 and the second plugging disc 2.
In some embodiments, the proximal end of the adjustment section 32 and the proximal end of the locking section 33 are both manually pulled by an operator, and are not connected and pulled by the delivery device 4 by the proximal end of the adjustment section 32 and the proximal end of the locking section 33.
In some embodiments, the proximal end of the adjustment section 32 or the proximal end of the locking section 33 is connected to the delivery device 4; in the embodiment that the conveying device 4 is connected to the proximal end of the adjusting section 32, when the wire loop of the wire knot is in an untruncated state, the conveying device 4 can pull the adjusting section to drive the adjusting wire loop to pass through the wire knot, so that the distance between the first plugging disc 1 and the second plugging disc 2 is adjusted; in embodiments where the delivery device 4 is coupled to the locking segment 33, the locking segment 33 can be pulled by controlling the delivery device 4 such that the wire loop of the wire knot 4 contracts to lock the adjustment segment 32.
Because the adjusting section 32 and the locking section 33 are movable wires connected to the plugging disc, the plugging disc can be moved by independently operating the adjusting section 32 and the locking section 33, and the operability is poor; preferably, the delivery device 4 is further connected to the second occlusion disc 2, in particular, after the first occlusion disc 1 and the second occlusion disc 2 are released, the second occlusion disc 2 is fixed to the distal end of the delivery device 4 before the delivery device 4 is withdrawn from the atrium, thereby avoiding simultaneous shaking of the two occlusion discs when the adjustment segment 32 and the locking segment 33 are pulled, in order to adjust the length of the adjustment wire loop 31 and to lock the adjustment segment 32 by the knot 34.
Specifically, in the plugging system shown in fig. 1, the first plugging disc 1 and the second plugging disc 2 are of a single-layer net disc structure, each net disc is formed by braiding nickel titanium wires, and each plugging disc is sheet-shaped. Each plugging disc comprises a framework woven by nickel titanium wires and a coating film attached to the framework. In other embodiments, the specific structure of each plugging disc is not limited, and each plugging disc may be a double-layer net disc, or be columnar, or claw-shaped.
The delivery device 4 comprises a handle 41 and a nitinol tube 42 arranged at the distal end of the handle 41, the distal end of the nitinol tube 42 is connected with the second sealing disc 2, the adjusting section 32 penetrates into the nitinol tube 42 and is connected with a driving mechanism in the handle 41, the other end of the adjusting section is knotted on the nitinol tube 42 to form a knot 34, the knot 34 tied on the nitinol tube 42 is a sliding knot, two ends of the tightening member 3 penetrate through a cavity in the handle 41 to connect with the driving mechanism in the handle 41, the driving mechanism can adjust the distance between the two sealing discs by pulling the adjusting section 32 of the tightening member 3, and the driving mechanism can lock the knot 34 by pulling the locking section 33 so that the distance between the two sealing discs is locked.
Embodiment one:
referring to fig. 2, the knot 34 includes a base knot 341 and a locking knot 342, i.e., the knot 34 includes a plurality of knots including the base knot 341 and the locking knot 342. The locking section 33 is connected to one end of the locking wire loop 342, the adjusting section 32 is connected to one end of the adjusting wire loop 31, and the base wire loop 341 is connected between the end of the locking wire loop 342 and the end of the adjusting wire loop 31. Thus, when the locking segment 33 is pulled, both the locking wire loop 342 and the base wire loop 341 contract. The adjustment section 32 passes through at least one of the base wire loop 341 and the locking wire loop 342, and in this embodiment, the adjustment section 32 passes through the base wire loop 341 and the locking wire loop 342, so that both the locking wire loop 342 and the base wire loop 341 can lock the adjustment section 32 after pulling the locking section 33. In a modified embodiment, the adjustment section 32 passes through one of the base wire loop 341 and the locking wire loop 342, and at least through one reinforcement wire loop 345 (reinforcement wire loop 345 is illustrated in other embodiments).
In the embodiment shown in fig. 2, the base wire loop 341 is disposed proximal of the locking wire loop 342. In the plugging system of the application, the line knot 34 is locked by pulling the locking section 33 proximally, in the whole locking process of the line knot 34, the locking line loop 342 is driven by the locking section 33 to move proximally to lock, among a plurality of line loops penetrated by the adjusting section 32, the locking line loop 342 is positioned at the far side of the basic line loop 341 or at least one other line loop, so that other line loops penetrated by the adjusting section 32 are pushed to gather proximally in the process of locking the locking line loop 342 by moving proximally, and the positions of the line loops penetrated by the adjusting section 32 in the line knot 34 are relatively concentrated after the locking section 33 is tensioned, so that the line loops can be contracted at one place, and the locking function of the adjusting section 32 is realized; the problem that the plurality of wire loops through which the adjusting section 32 passes cannot be gathered together after the locking section 33 is tightened and the adjusting section 32 can slide in the plurality of wire loops through which the adjusting section 32 cannot be locked is avoided.
In other embodiments, the base wire loop 341 may also be disposed distally of the locking wire loop 342, with the base wire loop 341 being pulled by the end connected to the locking wire loop 342 and gathered with the locking wire loop 342. In some embodiments, the base wire loop 341 and the locking wire loop 342 are arranged side by side, i.e. the base wire loop 341 and the locking wire loop 342 are arranged in substantially the same axial position.
The knot 34 further comprises a first connecting section 343, the first connecting section 343 being connected between the base wire loop 341 and the locking wire loop 342. In this embodiment, two ends of the first connection section 343 are respectively connected to the ends of the base wire loop 341 and the locking wire loop 342, so that the locking section 33 drives the locking wire loop to move proximally during the process of locking the wire loop 34, the locking wire loop 342 pulls the proximal portion of the base wire loop 341 and moves all the way towards the locking wire loop 342 through the first connection section 343, and the locking wire loop 342 moves in opposite directions with the base wire loop 341, so that the locking wire loop 342 and the base wire loop 341 are gathered together and the adjusting section 32 is locked. In some embodiments, the two ends of the first connection section 343 are not connected to the ends of the base wire loop 341 and the locking wire loop 342 facing away from each other, and may be connected to the two ends of the base wire loop 341 and the locking wire loop 342 facing toward each other, or one end of the first connection section 343 is connected to any one end of the base wire loop 341, and the other end of the first connection section 343 is connected to any one end of the locking wire loop 342.
The adjoining first connecting section 343, part of the basic wire loop 341, part of the locking wire loop 342, and part of the adjusting section 32 passing through the wire loop 34 of the knot 34 enclose a locking space 346. The knot 34 further comprises a second connecting section 344, one end of the second connecting section 344 being connected to the base wire loop 341 and the other end being connected to the adjustment wire loop 31. In the present embodiment, the second connecting section 344 is penetrated from the locking space 346 such that when the locking section 33 is pulled, the locking space 346 contracts and tightens the end of the second connecting section 344, thereby locking the end of the adjustment wire loop 31.
The lock space 346 is a loop of wire defined by adjoining sections of the knot 34 and sections of the conditioning segment 32 passing through the knot 34. By definition, the section of the tuning wire loop 31 that passes through the knot 34 adjacent to the tuning section 32 in the loose condition of the knot 34 is part of the tuning section 32. In the locked state of the knot 34, the end of the adjustment section 32 and the end of the adjustment wire loop 31 are locked in the knot 34.
As shown in fig. 2, the adjacent sections of the knot 34 that enclose the locking space 346 include a first connecting section 343, a portion of the base wire loop 341 connected to the end of the first connecting section 343, and a portion of the locking wire loop 342 connected to the other end of the first connecting section 343, the three sections of wire are adjacent to each other and enclose a C-shaped split ring, the opening of which is directed upward in fig. 2, and is blocked by the portion of the adjustment section 32 that passes through the knot 34. Further, one end of the section of the base wire loop 341 enclosing the locking space 346 is connected to the first connecting section 343, and the other end is connected to (in particular wound around) the adjusting section 32; one end of the section of the locking wire loop 342 enclosing the locking space 346 is connected to the first connecting section 343 and the other end is connected to (in particular wound around) the adjusting section 32.
When the wire knot 34 is tightened by pulling the locking segment 33, the area of the locking space 346 is reduced and the end of the second connecting segment 344 is locked after the base wire loop 341 and the locking wire loop 342 are contracted. That is, after the adjustment section 32 is locked by the knot 34, the end of the second connection section 344 is clamped by the base wire loop 341, the locking wire loop 342, the first connection section 343 and the adjustment section 32, thereby locking both ends of the adjustment wire loop 31 and improving the locking strength of the knot 34 to the adjustment wire loop 31.
Preferably, as shown in fig. 2, the locking section 33 also passes through the locking space 346, so that after the adjusting section 32 is locked by the knot 34, the end of the locking section 33 is also tightened by the base wire loop 341, the locking wire loop 342, the first connecting section 343 and the adjusting section 32, thereby improving the locking strength of the knot 34 to the adjusting wire loop 31.
Referring to fig. 6, in a further embodiment, the locking segment 33 is threaded out of the locking space 346 and also through the adjustment wire loop 31, and after the locking space 346 is contracted, the wire loop 34 abuts against the second sealing disc 2 from the proximal side to the distal side to the tissue surface, and the locking segment 33 is clamped by the wire loop 34 and the second sealing disc 2 in addition to the base wire loop 341, the locking wire loop 342, the first connecting segment 343 and the adjustment segment 32, so that the locking strength of the wire loop 34 to the adjustment wire loop 31 is improved.
Referring to fig. 3-5 and 7-8, the knot 34 further comprises at least one reinforcement wire loop 345, with the adjustment member 32 passing through at least one reinforcement wire loop 345. By reinforcing the arrangement of the wire loops 345, the number of wire loops through which the tuning section 32 passes is increased, improving the locking performance of the knot 34.
In fig. 3 to 5 and fig. 7 to 8, the adjustment section 32 passes through the base wire loop 341 and the locking wire loop 342, and also passes through the reinforcing wire loop 345. It will be appreciated that the adjustment segment 32 may be selectively threaded through any of the base wire loop 341, the locking wire loop 342, and all of the reinforcement wire loops 345, e.g., the adjustment segment 32 may be threaded through at least one of the base wire loop 341 and the locking wire loop 342, and on the basis of this, may be selectively threaded through at least one reinforcement wire loop 345, thereby satisfying the condition that the adjustment segment 32 is threaded through at least two wire loops; or as in the previous embodiments, the adjustment segment 32 passes through the base wire loop 341 and the locking wire loop 342 and does not pass through the reinforcement wire loop 345 (no reinforcement wire loop 345 is provided in the knot 34, or no reinforcement wire loop 345 is provided in the knot 34 and the adjustment segment 32 does not pass through the reinforcement wire loop 345); or the knot 34 comprises a plurality of reinforcement loops 345, the adjustment section 32 passing through at least two reinforcement loops 345 and not through the base loop 341 and the locking loop 342.
The greater the number of reinforcement wire loops 345 that the adjustment section 32 passes through, the greater the locking strength of the adjustment section 32 by the knot 34, but if the number of reinforcement wire loops 345 is excessive, this may result in pulling the locking section 33 to tighten only a portion of the reinforcement wire loops 345 and not all of the reinforcement wire loops 345. In the embodiment shown in fig. 3-5, for example, a plurality of reinforcement wire loops 345 are wound around the adjustment section 32 in a helical arrangement and connected in sequence. Preferably, each reinforcement wire loop 345 is looped one turn (360 degrees) around the adjustment section 32, it being understood that in some embodiments, portions of the reinforcement wire loops 345 are looped more than one turn or less than one turn around the axial direction. One of the plurality of reinforcement wire loops 345, which is adjacent to the lock wire loop 342, is connected to an end of the lock wire loop 342. In the process of pulling the locking section 33, after tightening the locking wire loop 342, the locking wire loop 342 sequentially drives the reinforcing wire loops 345 connected with the locking wire loop 342, and if the number of the reinforcing wire loops 345 is too large, a larger friction force is generated between the locking wire loop 342 and a part of the reinforcing wire loops 345 which are already locked and the adjusting section 32 in the process of continuously pulling the locking section 33 to lock the not-yet-locked reinforcing wire loops 345, so that the locking section 33 cannot continue to move proximally, and the part of the reinforcing wire loops 345 cannot be locked. The same problems as described above apply to the embodiments shown in fig. 7-8.
Preferably, the number of the reinforcing wire loops 345 is 4-8, on one hand, the operation of an operator is convenient, on the other hand, the locking force can reach between 5N and 40N, and the locking wire knot 34 is prevented from being released under the action of pressure difference between the left atrium and the right atrium, so that the reliability and the safety of locking the wire knot 34 are improved. In the embodiments shown in fig. 3, 5 and 7, the number of reinforcement wire loops 345 is 2, and in the embodiments shown in fig. 4 and 8, the number of reinforcement wire loops 345 is 4.
In detail, the reinforcement wire loops 345 may be formed by winding first connection segments 343, as shown in fig. 3-5. The reinforcement wire loops 345 may also be formed by wrapping the second connecting section 344, as shown in fig. 7-8.
Preferably, as shown in fig. 3-5, and fig. 7-8, the reinforcement wire loop 345, the base wire loop 341 and the locking wire loop 342 are axially arranged, so that during the process of locking the wire knot 34, the locking wire loop 342 is convenient to push/pull the plurality of wire loops together in sequence along the axial direction and proximally, the positions of the wire loops penetrated by the adjusting section 32 in the wire knot 34 are relatively concentrated, the wire loops can be contracted in one place, and the locking function is played on the adjusting section 32; the problem that the plurality of wire loops through which the adjusting section 32 passes cannot be gathered together in the axial direction after the locking section 33 is tightened, the adjusting section 32 can slide in the plurality of wire loops through which the adjusting section 32 cannot be locked is avoided.
The arrangement mode of the reinforcing wire ring 345 includes:
a first mode: between two adjacent reinforcement wire loops 345, the distal end of the proximal reinforcement wire loop 345 is connected to the proximal end of the distal reinforcement wire loop 345 to facilitate smooth pulling of the locking segment 33, and each reinforcement wire loop 345 is contracted to lock the adjustment segment 32, as shown in fig. 3, 4, 7 and 8.
The second mode is as follows: between two adjacent reinforcement wire loops 345, the proximal end of the proximal reinforcement wire loop 345 is connected to the distal end of the distal reinforcement wire loop 345, i.e., the two adjacent reinforcement wire loops 345 are connected at their ends facing away from each other, such that the adjacent reinforcement wire loops 345 are locked to each other, increasing the locking strength of the knot 34, as shown in fig. 5.
In other embodiments, a mixture of the two arrangements of the reinforcement wire loops 345 may be used, for example, the reinforcement wire loop 345 near the locking wire loop 342 may be arranged in the second arrangement and the reinforcement wire loop 345 near the base wire loop 341 may be arranged in the first arrangement.
The arrangement order of the reinforcing wire ring 345, the locking wire ring 342, and the base wire ring 341 in the axial direction may be: the reinforcement wire ring 345, the locking wire ring 342 and the base wire ring 341 are sequentially arranged from far to near as shown in fig. 3 and 4, and accordingly, the adjustment section 32 sequentially passes through the reinforcement wire ring 345, the locking wire ring 342 and the base wire ring 341, so that the adjustment section 32 can be smoothly pulled.
The arrangement order of the reinforcing wire ring 345, the locking wire ring 342, and the base wire ring 341 in the axial direction may be: the locking wire loop 342, the reinforcing wire loop 345 and the base wire loop 341 are arranged in this order from far to near as in the embodiment shown in fig. 5, 7 and 8, and accordingly the adjustment section 32 passes through the locking wire loop 342, the reinforcing wire loop 345 and the base wire loop 341 in this order.
In some embodiments, the connection between the locking wire loop 342 and the reinforcement wire loop 345 and the base wire loop 341 may be in a first manner, i.e., the proximal end of the locking wire loop 342 is connected to the distal end of the reinforcement wire loop 345 located distally thereof, and the distal end of the base wire loop 341 is connected to the proximal end of the reinforcement wire loop 345 located proximally thereof, as shown in fig. 3, 4, 7 and 8. In some embodiments, the connection between the locking wire loop 342 and the reinforcement wire loop 345 and between the reinforcement wire loop 345 and the base wire loop 341 may also be in a second manner, i.e., the distal end of the locking wire loop 342 is connected to the proximal end of the reinforcement wire loop 345 located distally thereof, and the proximal end of the base wire loop 341 is connected to the distal end of the reinforcement wire loop 345 located proximally thereof, as shown in fig. 5.
In other embodiments, the arrangement order of the reinforcing wire ring 345, the locking wire ring 342, and the base wire ring 341 in the axial direction may be: the reinforcing wire loop 345, the base wire loop 341 and the locking wire loop 342 are arranged in this order from far to near, or the reinforcing wire loop 345 and the locking wire loop 342 are arranged in this order from far to near.
Embodiment two:
referring to fig. 9-12, the knot 34 includes a base knot 341, a locking knot 342, and a second connection section 344, the locking section 33 is connected to one end of the locking knot 342, the adjustment section 32 is connected to one end of the adjustment knot 31, and the base knot 341 is connected between the end of the locking knot 342 and the end of the adjustment knot 31.
The difference between the tightening member 3 of the second embodiment and the first embodiment is mainly that:
one end of the second connecting section 344 is connected with the base wire loop 341, and the other end is connected with the adjusting wire loop 31, in this embodiment, the second connecting section 344 at least passes through the locking wire loop 342, so that after the locking wire loop 342 is contracted, the ends of the second connecting section 344 and the adjusting section 32 are simultaneously locked, i.e. the two ends of the adjusting wire loop 31 are simultaneously locked, thereby improving the locking strength of the wire loop 34.
In the embodiment shown in fig. 9, the locking segment 33 is threaded out from the side of the locking wire loop 342 facing away from the adjusting wire loop 31, i.e. out between the locking wire loop 342 and the base wire loop 341, the locking segment 33 passing through the locking wire loop 342 and not through the base wire loop 341; the adjusting section 32 passes through the locking wire loop 342 and the base wire loop 341, after the knot is locked, the locking section 33 can be clamped between the locking wire loop 342 and the base wire loop 341, and the end part of the adjusting section 32 can be tightly tied in the locking wire loop 342 and the base wire loop 341, so that the locking strength of the knot is ensured.
In the embodiment shown in fig. 10 and 11, the adjustment section 32 passes through the locking wire loop 342 and the base wire loop 341, so that the adjustment section 32 is locked by both the locking wire loop 342 and the base wire loop 341. In a modified embodiment, the locking segment 33 may also be threaded out from between the base wire loop 341 and the locking wire loop 342, so that after the wire knot is tightened, the end of the locking segment 33 is locked to prevent the wire knot 34 from loosening.
Further, as shown in fig. 12, the adjusting section 32 may also pass through the adjusting wire loop 31, that is, pass through the adjusting wire loop 31 and be located at a position near the second plugging disc 2, so that after the knot 34 is tightened, the end of the adjusting section 32 is locked by the knot 34, and is clamped by the knot 34 and the second plugging disc 2, so as to improve the locking strength of the end of the adjusting section 32.
In an embodiment, as shown in fig. 11 and 12, at least one reinforcing wire ring 345 is formed between the base wire ring 341 and the locking wire ring 342, so as to increase the number of wire rings of the wire knot 34, and the adjusting section 32 and the locking section 33 are both penetrated out of the reinforcing wire ring 345, so that the locking strength of the wire knot 34 on the adjusting section 32 and the locking section 33 is improved, and the wire knot is prevented from loosening. The locking section 33 passes through at least one of the reinforcing wire ring 345 and the base wire ring 341, so that after the locking section 33 is pulled, the locking section 33 is locked by at least one of the reinforcing wire ring 345 and the base wire ring 341, thereby ensuring that the wire knot 34 cannot be loosened.
Embodiment III:
as shown in fig. 13, the wire knot 34 includes a base wire loop 341, an adjusting wire loop 31, and a second connecting section 344, the locking section 33 is connected to one end of the locking wire loop 342, the adjusting section 32 is connected to one end of the adjusting wire loop 31, the base wire loop 341 is connected between the end of the locking wire loop 342 and the end of the adjusting wire loop 31, one end of the second connecting section 344 is connected to the base wire loop 341, and the other end is connected to the adjusting wire loop 31. Wherein the locking wire loop 342 is sleeved on the base wire loop 341, specifically, one end of the locking section 33 connected with the locking wire loop 342 passes through the base wire loop 341; the locking wire loop 342 is mutually sleeved with the adjusting wire loop 31, namely, the locking wire loop 342 passes through the adjusting wire loop 31.
The second connecting section 344 is wound around the locking wire loop 342 to form at least one reinforcing wire loop 345, i.e. the second connecting section 344 passes through the locking wire loop 342, and the adjusting section 32 passes through the base wire loop 341 and the reinforcing wire loop 345. In some embodiments, the adjustment section 32 may pass through at least one of the base wire loop 341 and the reinforcement wire loop 345 such that the end of the adjustment section 32 can be locked after the knot 34 is locked.
In some embodiments, the locking wire loop 342 and the adjustment wire loop 31 are not nested with each other.
In this embodiment, the adjustment section 32 does not pass through the locking wire loop 342, but is locked by the base wire loop 341 and the reinforcement wire loop 345. Wherein, after pulling the locking section 33, the locking wire loop 342 is contracted such that the base wire loop 341 and the reinforcing wire loop 345 are gathered, and the base wire loop 341 and the reinforcing wire loop 345 are contracted to achieve locking of the adjusting section 32. In the present embodiment, the locking wire loop 342 is sleeved on the base wire loop 341 and the adjusting wire loop 31, and the locking wire loop 342 is gradually reduced in the process of pulling the locking section 33 to tighten the locking wire loop 342, so that the locking wire loop 342 and the base wire loop 341 are mutually gathered in the process of pulling the adjusting wire loop 31 to shrink, thereby improving the efficiency and reliability of wire knot locking.
Embodiment four:
as shown in fig. 14, the knot 34 includes a locking wire loop 342, the locking wire loop 342 is located proximal to the adjustment wire loop 31, one end of the adjustment wire loop 31 is connected to the locking wire loop 342, the other end is connected to the adjustment section 32, and the adjustment section 32 passes through the locking wire loop 342 and the adjustment wire loop 31. In this embodiment, during the process of forming the knot 34, the adjusting section 32 passes through the locking wire loop 342 (specifically, the end of the adjusting section 32 passes through the locking wire loop 342) and then passes through the adjusting wire loop 31, so when the locking section 33 is pulled, the locking wire loop 342 contracts to lock the adjusting section 32, and simultaneously, the locking wire loop 342 and the second plugging disc 2 clamp the adjusting section 32, so as to improve the locking performance of the adjusting wire loop 31.
The embodiment of the application provides a knotting method of a tightening member 3 in the plugging system, which comprises the following steps:
the knot 34 is formed by winding a wire, and the adjustment wire loop 31 is connected distally of the knot 34, the wire forming two sections including ends proximal of the knot 34, respectively an adjustment section 32 and a locking section 33. In detail, the wire comprises a locking section 33, a first section for winding into a knot 34, a second section for forming an adjustment wire loop 31, and an adjustment section 32, which are connected in sequence.
In one embodiment, the knot 34 is formed by winding a wire, and the adjusting wire loop 31 is connected to the distal side of the knot 34, the wire forms two sections with ends on the proximal side of the knot 34, namely an adjusting section 32 and a locking section 33, and the steps specifically include: s11: winding the first section to form a knot 34, the knot 34 comprising a plurality of loops; s12: the adjustment segment 32 is guided through at least two of the plurality of loops of the knot 34 such that the second segment forms the adjustment loop 31 resulting in the cinch member 3.
Wherein, in step S12, at least two wire loops through which the adjustment section 32 is guided may include a base wire loop 341 and a locking wire loop 342, such as the tightening member 3 shown in fig. 2, 6 and 9; reinforcing wire loops 345, such as the cinch member 3 shown in figures 3-5 and 7-8, may also be included; a base wire loop 341 and a reinforcement wire loop 345 may also be included, but not through the lock wire loop 342, such as the cinch member 3 shown in fig. 13. In alternative embodiments, the plurality of reinforcement wire loops 345 may be threaded without the base wire loops 341 and/or the locking wire loops 342.
In another embodiment, in the step of winding a wire to form the knot 34 and attaching the adjustment wire loop 31 distal to the knot 34, the wire forms a section having two ends proximal to the knot 34, an adjustment section 32 and a locking section 33, respectively, specifically comprising: s21: winding the first section to form a knot 34, the knot 34 comprising at least one loop of wire; s22: guiding the adjustment segment 32 through at least one wire loop in the knot 34 such that the second segment forms an adjustment wire loop 31 distal to the knot 34; s23: the adjustment segment 32 is guided through the adjustment wire loop 31, resulting in said tightening element 3.
Wherein, in step S22, the adjusting section 32 may pass through only the locking wire loop 342 and the adjusting wire loop 31 to obtain the tightening member 3 as shown in fig. 14, wherein the wire knot 34 comprises only one wire loop, which is the locking wire loop 342. In other embodiments, the adjustment segment 32 may also pass through the adjustment wire loop 31, as well as multiple wire loops in the knot 34, such as the lock wire loop 342 and other wire loops in the knot 34, for example, in fig. 12, the adjustment segment 32 passes through the base wire loop 341 and the reinforcement wire loop 345 in the knot 34 in addition to the lock wire loop 342 and the adjustment wire loop 31.
Note that, the above reference numerals S11, S12, S21, S22, S23 are only used to distinguish between different steps, and are not used to limit the execution sequence of the steps.
The plugging system needs to be matched with a guide wire, an expander and the like in the use process. For example: conveying the conveying device to the middle part of the left atrium through a guide wire; then the guide wire is withdrawn, the plugging system is conveyed into the atrium by utilizing the conveying device, so that two plugging discs of the plugging system are respectively released at two sides of the defect, and then the end part of the adjusting section 32 is pulled proximally by the conveying device, so that the length of the adjusting wire loop is reduced, and the two plugging discs are respectively stuck to two sides of the defect; the end of the locking section 33 is then pulled proximally by the delivery device, causing the knot 34 to contract to lock the adjustment section 32; finally, the redundant line segments are cut off through the line cutting device, and the conveying device and the line cutting device are withdrawn, so that implantation of the plugging system is completed.
It should be noted that, the specific technical solutions in each embodiment/mode of the present application may be mutually applicable under the condition that the technical principles are not contradictory, that is, the specific technical features in each embodiment/mode may be mutually combined under the condition that the technical principles are not contradictory, and the technical solutions obtained by mutually combining the technical features also belong to the protection scope of the present application.
It will be understood that equivalents and modifications will occur to those skilled in the art based on the present application and its application, and all such modifications and substitutions are intended to be included within the scope of the present application.
Claims (8)
1. A closure system for sealing a defect in the vasculature, comprising:
a first occlusion disk and a second occlusion disk for covering different openings of the defect;
the tightening piece comprises an adjusting wire loop, an adjusting section, a locking section and a wire knot, wherein the adjusting section and the locking section are connected to the proximal side of the wire knot, the adjusting wire loop is connected to the distal side of the wire knot, the adjusting section, the locking section and the wire knot are arranged on one side, away from the first plugging disc, of the second plugging disc, a part of the adjusting wire loop is connected between the first plugging disc and the second plugging disc, and the adjusting wire loop is used for being penetrated in the defect;
The knot comprises at least one loop of wire, the adjustment section passing through the knot and at least two of the adjustment loops of wire; the wire knot comprises a base wire loop and a locking wire loop; the locking section is connected with one end of the locking wire ring, the adjusting section is connected with one end of the adjusting wire ring, and the base wire ring is connected between the end of the locking wire ring and the end of the adjusting wire ring; the wire knot comprises a second connecting section, one end of the second connecting section is connected with the basic wire loop, the other end of the second connecting section is connected with the adjusting wire loop, and the second connecting section at least penetrates through the locking wire loop; the adjusting section passes through the locking wire loop and the base wire loop; the adjustment section also passes through the adjustment wire loop; and
the locking section is used for driving the wire loop in the wire knot to shrink so that the wire knot locks the end part of the adjusting section.
2. The occlusion system of claim 1, wherein said occlusion system comprises a delivery device coupled to a proximal end of said adjustment section for pulling said adjustment section to move said adjustment wire loop proximally through said wire knot to adjust a distance between said first occlusion disk and said second occlusion disk; and/or
The delivery device is coupled to the proximal end of the locking section and is configured to pull the locking section.
3. The occlusion system of claim 1, wherein said base wire loop is disposed proximal to said locking wire loop.
4. The occlusion system of claim 1, wherein the occlusion system comprises a plurality of occlusion devices,
the locking segment passes through the base wire loop.
5. The occlusion system of claim 1, wherein the occlusion system comprises a plurality of occlusion devices,
at least one reinforcing wire loop is formed between the base wire loop and the locking wire loop, and the locking section passes through at least one wire loop of the reinforcing wire loop and the base wire loop.
6. A method of knotting a tightener in a closure system according to any one of claims 1 to 5, comprising the steps of:
the knot is formed by winding a wire, and the adjustment wire loop is connected distal to the knot, the wire forming two sections including ends proximal to the knot, the adjustment section and the locking section, respectively.
7. The method of knotting a tightener according to claim 6, wherein the wire comprises the locking section, a first section, a second section and the adjustment section connected in sequence;
In the step of winding the wire knot with a wire to form the knot and the adjustment wire loop connected on the distal side of the knot, the wire knot forms two sections including ends on the proximal side of the knot, respectively the adjustment section and the locking section, specifically comprising:
winding the first section to form the knot, the knot comprising a plurality of loops;
the adjustment segment is guided through at least two wire loops of the plurality of wire loops of the wire knot such that the second section forms the adjustment wire loop resulting in the cinch member.
8. The method of knotting a tightener according to claim 6, wherein the wire comprises the locking section, a first section, a second section and the adjustment section connected in sequence;
in the step of winding the wire knot with a wire to form the knot and the adjustment wire loop connected on the distal side of the knot, the wire knot forms two sections including ends on the proximal side of the knot, respectively the adjustment section and the locking section, specifically comprising:
winding said first section to form said knot, said knot comprising at least one loop of wire,
Guiding the adjustment segment through at least one wire loop of the knot such that the second section forms the adjustment wire loop distal to the knot;
and guiding the adjusting section to pass through the adjusting wire ring to obtain the tightening piece.
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| CN202310235543.0A CN116509468B (en) | 2023-03-13 | 2023-03-13 | Plugging system and knotting method of tightening piece |
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