CN117224278B - Lumen flow regulator and coronary sinus constriction device - Google Patents
Lumen flow regulator and coronary sinus constriction device Download PDFInfo
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- CN117224278B CN117224278B CN202311493558.3A CN202311493558A CN117224278B CN 117224278 B CN117224278 B CN 117224278B CN 202311493558 A CN202311493558 A CN 202311493558A CN 117224278 B CN117224278 B CN 117224278B
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Abstract
The invention provides a lumen flow regulator and a coronary sinus constriction device. The lumen flow regulator comprises an inner layer net and an outer layer net which are nested, wherein the inner layer net and the outer layer net are made of elastic wires, a third end of the outer layer net is connected with a first end of the inner layer net, the inner layer net extends along the axial direction to form a lumen channel, and the inner layer net is gradually inwards recessed from two ends in opposite directions to form a reducing section; the lumen flow regulator has a storage state in which the outer layer mesh is separated from the outer surface of the inner layer mesh and extends in sequence with the inner layer mesh in the axial direction; when the storage state is switched to the release state, the fourth end of the outer layer net is turned outwards and gradually approaches the second end of the inner layer net until the outer layer net and the inner layer net are completely attached. The invention solves the problem of poor supporting effect of the lumen flow regulator in the prior art.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a lumen flow regulator and a coronary sinus constriction device.
Background
Angina pectoris is a clinical syndrome mainly manifested by episodic chest pain or chest discomfort caused by coronary insufficiency, acute ischemia of cardiac muscle and hypoxia. Angina pectoris is pain felt by heart ischemia reflected to the body surface, and is characterized by paroxysmal and squeezing pain of the chest, which may be accompanied by other symptoms, the pain is mainly located at the rear part of the sternum, and can radiate to the precordial region and the left upper limb, and the direct onset cause of angina pectoris is myocardial ischemia, usually symptoms of coronary artery disease.
Lumen flow regulators are considered as a solution highly desirable for the treatment of refractory angina, the principle of action of which is: an interventional passage is established through minimally invasive surgery, a lumen flow regulator is conveyed to a coronary sinus implantation position through a right atrium through the passage, the coronary sinus inner diameter is narrowed, a trans-sinus pressure gradient is established, the backpressure is increased, the epicardial and endocardial blood flow perfusion proportion is improved, and the oxygen-enriched blood flows to a heart region with abnormal blood flow before, so that the aim of relieving myocardial ischemia is fulfilled.
The existing lumen flow regulator is generally formed by expanding a cutting framework through a balloon, delivering the device to a target position through a delivery system, and expanding the device through the balloon to enable the device to be tightly attached to the wall of a blood vessel, narrow the inner diameter of the coronary sinus, raise back pressure and improve the perfusion proportion of blood flow. However, current lumen flow regulators require balloon dilation during release, which is cumbersome; a larger gap exists between the outer side of the central narrow section and the blood vessel, the contact area between the device and the wall of the blood vessel is small, the endothelialization speed is low and the support is lacking; the length of the device is longer, other branch blood vessels can be influenced, and the requirement on the placement position of the instrument is high; the instrument is not recoverable, the re-release is difficult to realize during operation, and the risk during operation and the emergency treatment are relatively difficult.
From the above, the prior art has a problem that the supporting effect of the lumen flow regulator is poor.
Disclosure of Invention
The invention mainly aims to provide a lumen flow regulator and a coronary sinus constriction device, which are used for solving the problem of poor supporting effect of the lumen flow regulator in the prior art.
To achieve the above object, according to one aspect of the present invention, there is provided a lumen flow regulator comprising: the inner layer net and the outer layer net are nested, the inner layer net and the outer layer net are made of elastic wires, the third end of the outer layer net is connected with the first end of the inner layer net, the inner layer net extends along the axial direction to form a lumen channel, and the inner layer net is recessed inwards gradually from two ends to form a reducing section; the lumen flow regulator has a storage state in which the outer layer mesh is separated from the outer surface of the inner layer mesh and extends in sequence with the inner layer mesh in the axial direction; when the storage state is switched to the release state, the fourth end of the outer layer net is turned outwards and gradually approaches the second end of the inner layer net until the outer layer net and the inner layer net are completely attached.
Further, the inner layer net and the outer layer net are both woven by elastic wires.
Further, the fourth end of the outer web has an inwardly folded edge.
Further, the second end of the inner web has an inwardly folded edge.
Further, the lumen channel comprises a first expansion section and a second expansion section, the first expansion section and the second expansion section are respectively communicated with the diameter reduction section in sequence, and the inner diameter of the first expansion section is larger than the inner diameter of the second expansion section.
Further, the reduced diameter section is located at a central location between the first end and the second end of the inner layer web; or the diameter-reducing section is close to the second end of the inner layer net relative to the first end of the inner layer net; or the reduced diameter section is adjacent to the first end of the inner layer web relative to the second end of the inner layer web.
Further, the lumen flow regulator further includes a connector disposed at the second end of the inner mesh for connection with a delivery assembly of the coronary sinus narrowing device.
In accordance with another aspect of the present invention, there is also provided a coronary sinus constriction device comprising a delivery assembly and the above-described lumen flow regulator, the lumen flow regulator being removably connected to the delivery assembly.
Further, the delivery assembly includes: the conveying steel cable is detachably connected with the connecting piece of the lumen flow regulator; the delivery sheath, the lumen flow regulator is housed within the delivery sheath.
Further, in the storage state, the lumen flow regulator is completely contained in the delivery sheath, and the outer layer net of the lumen flow regulator is separated from the outer surface of the inner layer net of the lumen flow regulator and extends along the axial direction sequentially with the inner layer net; when the storage state is switched to the release state, the conveying sheath tube is gradually retracted so that the fourth end of the outer layer net gradually extends out of the conveying sheath tube, the fourth end of the outer layer net is outwards folded and gradually approaches to the second end of the inner layer net, and when the lumen flow regulator is completely separated from the conveying sheath tube, the outer layer net is completely attached to the inner layer net.
By applying the technical scheme of the invention, the lumen flow regulator comprises an inner layer net and an outer layer net which are nested, wherein the inner layer net and the outer layer net are made of elastic wires, a third end of the outer layer net is connected with a first end of the inner layer net, the inner layer net axially extends to form a lumen channel, and the inner layer net is gradually inwards recessed from two ends towards each other to form a reducing section; the lumen flow regulator has a storage state in which the outer layer mesh is separated from the outer surface of the inner layer mesh and extends in sequence with the inner layer mesh in the axial direction; when the storage state is switched to the release state, the fourth end of the outer layer net is turned outwards and gradually approaches to the second end of the inner layer net until the outer layer net and the inner layer net are completely attached, so that throttling adjustment is realized by arranging the reducing section, back pressure is increased, the epicardial and endocardial blood flow perfusion proportion is improved, the lumen flow regulator is provided with a single-layer net shape and a double-layer net shape, the radial supporting force of the lumen flow regulator can be enhanced by the double-layer net structure, the supporting effect of the lumen flow regulator is improved, the diameter of a delivery sheath tube can be reduced as much as possible in the sheath collecting and delivering processes, the damage possibly occurring in the lumen flow regulator delivering process is reduced, and the problem that the supporting effect of the lumen flow regulator is poor in the prior art is solved. In addition, because the inner layer net and the outer layer net are made of elastic wires, the state of the double-layer net can be automatically recovered from the single-layer net state in the release process according to the metal memory attribute, and the release of the lumen flow regulator can be realized without other parts, thereby being convenient and quick.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention. In the drawings:
FIG. 1 illustrates a schematic diagram of a lumen flow regulator in one embodiment of the present invention;
FIG. 2 is a schematic diagram showing a lumen flow regulator in a stowed state in accordance with one embodiment of the present invention;
FIG. 3 illustrates a schematic view of the delivery sheath of the coronary sinus narrowing device in an embodiment of the present invention beginning to retract;
FIG. 4 is a schematic diagram of a lumen flow regulator in an embodiment of the present invention switched from a stowed condition to a released condition;
fig. 5 shows a schematic structural view of a lumen flow regulator in a released state in one embodiment of the present invention.
Wherein the above figures include the following reference numerals:
10. an inner layer mesh; 11. a first end; 12. a second end; 20. an outer layer mesh; 21. a third end; 22. a fourth end; 30. a reducing section; 40. a first expansion section; 50. a second expansion section; 60. a connecting piece; 70. a transport assembly; 71. conveying a steel cable; 72. a delivery sheath.
Detailed Description
It should be noted that, in the case of no conflict, the embodiments and features in the embodiments may be combined with each other. The invention will be described in detail below with reference to the drawings in connection with embodiments.
It is noted that all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs unless otherwise indicated.
In the present invention, unless otherwise indicated, terms of orientation such as "upper, lower, top, bottom" are used generally with respect to the orientation shown in the drawings or with respect to the component itself in the vertical, upright or gravitational direction; also, for ease of understanding and description, "inner and outer" refers to inner and outer relative to the profile of each component itself, but the above-mentioned orientation terms are not intended to limit the present invention.
It will be apparent that the embodiments described above are merely some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present invention without making any inventive effort, shall fall within the scope of the present invention.
In order to solve the problem of poor supporting effect of a lumen flow regulator in the prior art, the invention provides the lumen flow regulator and a coronary sinus constriction device. Wherein the coronary sinus constriction device described below includes the lumen flow regulator described below.
As shown in fig. 1-5, the lumen flow regulator includes an inner layer of mesh 10 and an outer layer of mesh 20 in a nested arrangement. Both the inner layer 10 and the outer layer 20 are made of elastic filaments. The third end 21 of the outer layer mesh 20 is connected to the first end 11 of the inner layer mesh 10, the inner layer mesh 10 extends in the axial direction to form a lumen channel, and the inner layer mesh 10 is gradually recessed inward from both ends toward each other to form a reduced diameter section 30. The lumen flow regulator has a housed state in which the outer layer net 20 is separated from the outer surface of the inner layer net 10 and extends in sequence in the axial direction with the inner layer net 10; when switching from the storage state to the release state, the fourth end 22 of the outer layer web 20 is folded outwardly and gradually approaches the second end 12 of the inner layer web 10 until the outer layer web 20 is fully attached to the inner layer web 10. It will be appreciated that the inner layer 10 and the outer layer 20 in this embodiment are formed by folding a single layer structure into a nested double layer structure, that is, the third end 21 of the outer layer 20 is connected to the first end 11 of the inner layer 10 in sequence.
By arranging the reducing section 30 to realize throttling adjustment, the backpressure is increased, the epicardial and endocardial blood perfusion proportion is improved, the lumen flow regulator is provided with a single-layer net shape and a double-layer net shape, the radial supporting force of the lumen flow regulator can be enhanced by the double-layer net structure, the supporting effect of the lumen flow regulator is improved, the diameter of a delivery sheath can be reduced as much as possible in the sheath collecting and delivering process, and the damage possibly occurring in the delivery process of the lumen flow regulator is reduced.
The outer layer 20 and the inner layer 10 in this embodiment can be matched in a manner similar to that of a real life person taking off the glove.
In this embodiment, the inner layer mesh 10 and the outer layer mesh 20 are each woven from elastic filaments. The elastic wire has shape memory, the lumen flow regulator does not need balloon expansion after implantation, the operation is simplified, and the woven mesh structure can play a certain role in protecting the vessel wall in the implantation process, and the lumen flow regulator cannot generate larger impact force at a certain point in the release process to scratch or even puncture the vessel wall. Further, since the lumen flow regulator is switched from the storage state to the release state and the layer mesh is required to be folded, the elastic metal woven mesh has higher flexibility, so that the lumen flow regulator can smoothly switch the single-layer and double-layer mesh structure. Specifically, the elastic wire in the embodiment is nickel-titanium alloy or other medical memory metal harmless to human body, and even if the elastic wire is left in the patient for a long time, the elastic wire does not have adverse effect on the human body, so that the aim of treatment is achieved, and inconvenience is not brought to the daily life of the patient such as security check, general medical check and the like.
In this embodiment, the fourth end 22 of the outer mesh 20 has an inwardly bent edge to form a rounded end that minimizes irritation and injury to the vessel wall from the lumen flow regulator release. That is, in the process of switching from the storage state to the release state, the fourth end 22 of the outer layer net 20 is folded outwardly and moved along the outer surface of the inner layer net 10 to finally reach the second end 12 of the inner layer net 10, and the rounded edge end does not scratch the vessel wall during the movement. Further, the second end 12 of the inner layer 10 also has an inwardly folded edge so that the second end 12 of the inner layer 10 does not damage the vessel wall during release. Specifically, the inward bending is a bending in a direction towards the central axis of the lumen flow regulator.
As shown in fig. 1, the lumen channel includes a first expansion section 40 and a second expansion section 50, the first expansion section 40 and the second expansion section 50 are sequentially communicated with the reduced diameter section 30, respectively, and the inner diameter of the first expansion section 40 is larger than the inner diameter of the second expansion section 50. That is, the overall structure of the released lumen flow regulator is a "one-large-small" double horn. When the lumen flow regulator is installed at a specified position, blood flows through the lumen flow regulator, firstly enters the first expansion section 40, then enters the second expansion section 50 after being throttled at the reducing section 30, and then continuously flows downwards, so that the back pressure is improved, the epicardial and endocardial blood flow perfusion proportion is improved, the oxygen-enriched blood is increased to flow to the heart region with abnormal blood flow before, and the purpose of relieving myocardial ischemia is achieved.
In this embodiment, the reduced diameter section 30 is located centrally between the first end 11 of the inner layer web 10 and the second end 12 of the inner layer web 10. Through the arrangement, the lengths of the blood flowing through the reducing section 30 are kept consistent, so that the flow velocity change of the blood is stable, and a better throttling effect is realized. Of course, the diameter-reduced section 30 may be close to the second end 12 of the inner layer 10 with respect to the first end 11 of the inner layer 10, or the diameter-reduced section 30 may be close to the first end 11 of the inner layer 10 with respect to the second end 12 of the inner layer 10, which may be selected according to practical requirements.
As shown in fig. 2-5, the lumen flow regulator further includes a connector 60. A connector 60 is provided at the second end 12 of the inner web 10 for connection to a delivery assembly 70.
As shown in Figs. 2-5, the present invention also provides a coronary sinus constriction device comprising a delivery assembly 70 and the above-described lumen flow regulator. The lumen flow regulator is removably coupled to the delivery assembly 70.
As shown in fig. 2-5, the delivery assembly 70 includes a delivery cable 71 and a delivery sheath 72. Delivery cable 71 is removably connected to lumen flow regulator connector 60. The lumen flow regulator is housed within a delivery sheath 72.
In this embodiment, the delivery cable 71 is threaded with the connector 60. The delivery cable 71 is provided with an external thread and the connector 60 is provided with an internal thread adapted to the external thread of the delivery cable 71. The delivery cable 71 is connected to the lumen flow regulator via the connector 60, so that the lumen flow regulator can be correspondingly adjusted before the lumen flow regulator is not completely separated from the delivery sheath 72, thereby avoiding that the lumen flow regulator cannot realize the predetermined function due to the advanced release or the exceeding of the release position of the lumen flow regulator beyond the designated place caused by improper operation. In the release process, medical staff can adjust the release degree and the release position of the lumen flow regulator at any time, so that the risk of operation and emergency treatment difficulty are reduced.
The coronary sinus constriction device in this embodiment is used as follows:
first, the lumen flow regulator is placed within the delivery sheath 72 of the delivery assembly 70 and connected to the connector 60 by the delivery cable 71. In the accommodated state, the lumen flow regulator is completely accommodated in the delivery sheath 72 and the outer layer mesh 20 of the lumen flow regulator is separated from the outer surface of the inner layer mesh 10 of the lumen flow regulator and sequentially extends in the axial direction with the inner layer mesh 10, that is, the lumen flow regulator in the accommodated state is of a completely stretched single layer mesh structure. The lumen flow regulator is then moved to the lesion. When switching from the stowed condition to the released condition, the delivery sheath 72 is gradually retracted such that the fourth end 22 of the outer web 20 gradually extends out of the delivery sheath 72, and the fourth end 22 of the outer web 20 is folded outwardly and gradually approaches the second end 12 of the inner web 10. When the lumen flow regulator is completely detached from the delivery sheath 72, the outer layer mesh 20 is completely attached to the inner layer mesh 10. That is, with the gradual retraction of the delivery sheath 72, the outer mesh 20 is gradually exposed from the delivery sheath 72, so that the restriction on the lumen flow regulator is released, and the lumen flow regulator gradually returns to the original state, i.e., from the single-layer mesh structure to the double-layer mesh structure, under the action of the shape memory effect and the pulling of the delivery cable 71. After the lumen flow regulator is restored to the double-layer net structure, the connection between the delivery cable 71 and the connecting member 60 is released, so that the lumen flow regulator is separated from the delivery assembly 70 and supported and fixed at the lesion, and then the delivery assembly 70 is withdrawn from the human body, thereby completing the whole release process.
Further, before the lumen flow regulator is not completely separated from the delivery sheath 72, if the instrument is not positioned properly or otherwise, the delivery cable 71 or push delivery sheath 72 may be retracted and the lumen flow regulator may be retracted and released.
From the above description, it can be seen that the above embodiments of the present invention achieve the following technical effects: by arranging the reducing section 30 to realize throttling adjustment, the backpressure is increased, the epicardial and endocardial blood perfusion proportion is improved, the lumen flow regulator is provided with a single-layer net shape and a double-layer net shape, the radial supporting force of the lumen flow regulator can be enhanced by the double-layer net structure, the supporting effect of the lumen flow regulator is improved, the diameter of a delivery sheath can be reduced as much as possible in the sheath collecting and delivering process, and the damage possibly occurring in the delivery process of the lumen flow regulator is reduced.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments in accordance with the present application. As used herein, the singular is also intended to include the plural unless the context clearly indicates otherwise, and furthermore, it is to be understood that the terms "comprises" and/or "comprising" when used in this specification are taken to specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof.
It should be noted that the terms "first," "second," and the like in the description and claims of the present application and the above figures are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate such that embodiments of the present application described herein may be implemented in sequences other than those illustrated or described herein.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (9)
1. The lumen flow regulator is characterized by comprising an inner layer net (10) and an outer layer net (20) which are nested, wherein the inner layer net (10) and the outer layer net (20) are made of elastic wires, a third end (21) of the outer layer net (20) is connected with a first end (11) of the inner layer net (10), the inner layer net (10) extends along the axial direction to form a lumen channel, and the inner layer net (10) is gradually inwards recessed from two ends towards each other to form a reduced diameter section (30);
the lumen flow regulator has a stowed condition in which the outer layer mesh (20) is disengaged from the outer surface of the inner layer mesh (10) and extends axially in sequence with the inner layer mesh (10); when switching from the storage state to the release state, the fourth end (22) of the outer layer net (20) is turned outwards and gradually approaches the second end (12) of the inner layer net (10) until the outer layer net (20) is completely attached to the inner layer net (10);
the lumen flow regulator further comprises a connector (60), the connector (60) being disposed at the second end (12) of the inner mesh (10) for connection with a delivery assembly (70) of a coronary sinus constriction device.
2. The lumen flow regulator according to claim 1, characterized in that both the inner layer mesh (10) and the outer layer mesh (20) are woven from the elastic wire.
3. The lumen flow regulator according to claim 1, characterized in that the fourth end (22) of the outer mesh (20) has an inwardly bent edge.
4. The lumen flow regulator according to claim 1, characterized in that the second end (12) of the inner layer mesh (10) has an inwardly bent edge.
5. The lumen flow regulator of claim 1, wherein the lumen channel comprises a first expansion section (40) and a second expansion section (50), the first expansion section (40) and the second expansion section (50) are in sequential communication with the reduced diameter section (30), respectively, and an inner diameter of the first expansion section (40) is greater than an inner diameter of the second expansion section (50).
6. The lumen flow regulator of claim 1 wherein,
the diameter-reducing section (30) is positioned at a central position between the first end (11) and the second end (12) of the inner layer net (10); or alternatively
The reduced diameter section (30) is adjacent to the second end (12) of the inner layer web (10) relative to the first end (11) of the inner layer web (10); or alternatively
The reduced diameter section (30) is adjacent to the first end (11) of the inner layer web (10) relative to the second end (12) of the inner layer web (10).
7. A coronary sinus constriction device comprising a delivery assembly (70) and the lumen flow regulator of any one of claims 1 to 6, the lumen flow regulator being detachably connected to the delivery assembly (70).
8. The coronary sinus narrowing device according to claim 7, wherein the delivery assembly (70) includes:
a delivery cable (71), the delivery cable (71) being detachably connected to the lumen flow regulator connector (60);
a delivery sheath (72), the lumen flow regulator being housed within the delivery sheath (72).
9. The coronary sinus narrowing device according to claim 8, characterized in that in the stowed state the lumen flow regulator is fully housed within the delivery sheath (72) and the outer layer mesh (20) of the lumen flow regulator is detached from the outer surface of the inner layer mesh (10) of the lumen flow regulator and extends axially in sequence with the inner layer mesh (10); when the storage state is switched to the release state, the conveying sheath (72) is gradually retracted so that the fourth end (22) of the outer layer mesh (20) gradually extends out of the conveying sheath (72), the fourth end (22) of the outer layer mesh (20) is outwards folded and gradually approaches to the second end (12) of the inner layer mesh (10), and when the lumen flow regulator is completely separated from the conveying sheath (72), the outer layer mesh (20) is completely attached to the inner layer mesh (10).
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| CN202311493558.3A CN117224278B (en) | 2023-11-10 | 2023-11-10 | Lumen flow regulator and coronary sinus constriction device |
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| US6120534A (en) * | 1997-10-29 | 2000-09-19 | Ruiz; Carlos E. | Endoluminal prosthesis having adjustable constriction |
| CN102098983A (en) * | 2008-07-24 | 2011-06-15 | Aga医药有限公司 | Multi-layered medical device for treating a target site and associated method |
| KR20110057514A (en) * | 2009-11-24 | 2011-06-01 | 김진태 | Double layer covered stent and implanting method of this stent |
| CN105188609A (en) * | 2013-03-15 | 2015-12-23 | 西美蒂斯股份公司 | Improvements relating to transcatheter stent-valves |
| WO2023088384A1 (en) * | 2021-11-17 | 2023-05-25 | 北京佰仁医疗科技股份有限公司 | Split type precisely-anchorable interventional aortic valve system |
| CN217366188U (en) * | 2022-03-03 | 2022-09-06 | 王建 | Flow self-adaptive coronary venous sinus current limiting device |
| CN219021785U (en) * | 2022-10-31 | 2023-05-16 | 上海微创医疗器械（集团）有限公司 | Vascular stent |
| CN116725732A (en) * | 2023-06-28 | 2023-09-12 | 广东脉搏医疗科技有限公司 | Lumen flow regulator and coronary sinus constriction device |
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