CN117224278B - Luminal flow regulator and coronary sinus constriction device - Google Patents

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

Luminal flow regulator and coronary sinus constriction device

Technical field

The present invention relates to the technical field of medical devices, and specifically to a lumen flow regulator and a coronary sinus constriction device.

Background technique

Angina pectoris is a clinical syndrome mainly characterized by paroxysmal chest pain or chest discomfort caused by insufficient coronary blood supply and acute temporary ischemia and hypoxia of the myocardium. Angina pectoris is pain that is reflected from cardiac ischemia to the surface of the body. It is characterized by paroxysmal, squeezing pain in the chest, which may be accompanied by other symptoms. The pain is mainly located at the back of the sternum and can radiate to the precordium and left upper limb. Angina pectoris The direct cause of the disease is insufficient blood supply to the heart muscle, usually a symptom of coronary artery disease.

The luminal flow regulator is considered a promising solution for the treatment of refractory angina. Its principle of action is to establish an interventional access through minimally invasive surgery, and the luminal flow regulator is delivered to the coronary sinus through the access through the right atrium. At the implantation site, the inner diameter of the coronary sinus is narrowed, a trans-sinus pressure gradient is established, which increases the back pressure, improves the ratio of epicardial and subendocardial blood flow perfusion, and increases the flow of oxygen-rich blood to the heart area where blood flow was previously abnormal. Thereby achieving the purpose of alleviating myocardial ischemia.

Existing luminal flow regulators are generally made by cutting a skeleton and expanding it with a balloon. The device is sent to the target position through a delivery system and expanded with a balloon to make it close to the blood vessel wall, narrow the inner diameter of the coronary sinus, and increase the flow rate of the coronary sinus. Back pressure improves blood perfusion ratio. However, the existing luminal flow regulator requires balloon expansion during the release process, which is cumbersome; there is a large gap between the outside of the central stenosis segment and the blood vessel, the contact area between the device and the blood vessel wall is small, the endothelialization rate is slow, and there is a lack of support. ; The length of the device is long, which may affect other branch blood vessels, and the device placement requirements are high; the device is not retrievable, and intraoperative adjustment and release are difficult to achieve, making intraoperative risks and emergency response difficult.

It can be seen from the above that there is a problem in the prior art that the support effect of the lumen flow regulator is poor.

Contents of the invention

The main purpose of the present invention is to provide a lumen flow regulator and a coronary sinus constriction device to solve the problem in the prior art that the support effect of the lumen flow regulator is poor.

In order to achieve the above object, according to one aspect of the present invention, a lumen flow regulator is provided, which includes: an inner layer of mesh and an outer layer of mesh arranged in a nested manner. The inner layer of mesh and the outer layer of mesh are both made of elastic wire. The third end of the outer mesh is connected to the first end of the inner mesh. The inner mesh extends along the axial direction to form a lumen channel, and the inner mesh gradually recesses inward from the two ends to form a reduced diameter section; the lumen flow is adjusted The device has a stowed state and a released state. In the stowed state, the outer net breaks away from the outer surface of the inner net and extends sequentially along the axial direction with the inner net; when switching from the stowed state to the released state, the third part of the outer net Fold the four ends outward and gradually approach the second end of the inner mesh until the outer mesh and the inner mesh are completely attached.

Further, both the inner layer mesh and the outer layer mesh are woven from elastic silk materials.

Further, the fourth end of the outer mesh has an inwardly bent edge.

Further, the second end of the inner mesh has an inwardly bent edge.

Further, the lumen channel includes a first expansion section and a second expansion section. The first expansion section and the second expansion section are respectively connected with the diameter reduction section in sequence, and the inner diameter of the first expansion section is greater than the inner diameter of the second expansion section.

Further, the reduced diameter section is located at a central position between the first end and the second end of the inner layer net; or the reduced diameter 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 The second end relative to the inner mesh is close to the first end of the inner mesh.

Further, the lumen flow regulator further includes a connecting piece, which is disposed at the second end of the inner mesh for connecting with the delivery component of the coronary sinus constriction device.

According to another aspect of the present invention, a coronary sinus constriction device is also provided, which includes a delivery component and the above-mentioned lumen flow regulator, and the lumen flow regulator is detachably connected to the delivery component.

Further, the delivery component includes: a delivery steel cable, the delivery steel cable is detachably connected to the connector of the lumen flow regulator; and a delivery sheath, and the lumen flow regulator is accommodated in the delivery sheath.

Further, in the stowed state, the lumen flow regulator is completely contained in the delivery sheath and the outer mesh of the lumen flow regulator is separated from the outer surface of the inner mesh of the lumen flow adjuster and is aligned with the inner mesh along the axis. Extend sequentially; when switching from the storage state to the release state, the delivery sheath gradually withdraws so that the fourth end of the outer mesh gradually extends out of the delivery sheath, and the fourth end of the outer mesh folds outward and gradually Near the second end of the inner mesh, when the lumen flow regulator is completely separated from the delivery sheath, the outer mesh is completely attached to the inner mesh.

Applying the technical solution of the present invention, the lumen flow regulator includes an inner mesh and an outer mesh that are nested. Both the inner mesh and the outer mesh are made of elastic wire. The third end of the outer mesh is connected to the inner mesh. The first end of the mesh is connected, and the inner mesh extends along the axial direction to form a lumen channel, and the inner mesh gradually recesses inward from the two ends to form a reduced diameter section; the lumen flow regulator has a stowed state and a released state. state, the outer net is separated from the outer surface of the inner net and extends along the axial direction sequentially with the inner net; when it is switched from the storage state to the release state, the fourth end of the outer net is folded outward and gradually approaches the inner net. The second end of the layer network until the outer layer network and the inner layer network are completely fitted, in this way, the throttling adjustment is achieved by setting the diameter reducing section, which increases the back pressure and improves the ratio of epicardial and subendocardial blood flow perfusion. The lumen flow regulator has a single-layer mesh form and a double-layer mesh form. The double-layer mesh structure can enhance the radial support force of the lumen flow regulator, thereby improving the support effect of the lumen flow regulator. The single-layer mesh form is in progress During the process of sheath retraction and delivery, the diameter of the delivery sheath can be reduced as much as possible, thereby reducing possible damage to the lumen flow regulator during delivery, and solving the problem of poor support effect of the lumen flow regulator in the prior art. . In addition, since both the inner and outer meshes are made of elastic wire, they can automatically return from a single-layer mesh to a double-layer mesh state during the release process based on the metal memory properties, and the lumen flow regulator can be realized without the need for other components. The release is convenient and quick.

Description of drawings

The description and drawings that constitute a part of this application are used to provide a further understanding of the present invention. The illustrative embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the attached picture:

Figure 1 shows a schematic structural diagram of a lumen flow regulator in a specific embodiment of the present invention;

Figure 2 shows a schematic structural diagram of the lumen flow regulator in a stowed state in a specific embodiment of the present invention;

Figure 3 shows a schematic structural diagram of the delivery sheath of the coronary sinus constriction device starting to retract in a specific embodiment of the present invention;

Figure 4 shows a schematic structural diagram of the lumen flow regulator switching from a storage state to a release state in a specific embodiment of the present invention;

Figure 5 shows a schematic structural diagram of the lumen flow regulator in a released state in a specific embodiment of the present invention.

Among them, the above-mentioned drawings include the following reference signs:

10. Inner mesh; 11. First end; 12. Second end; 20. Outer mesh; 21. Third end; 22. Fourth end; 30. Reducing section; 40. First expansion section; 50 , the second expansion section; 60. Connector; 70. Transport component; 71. Transport steel cable; 72. Transport sheath.

Detailed ways

It should be noted that, as long as there is no conflict, the embodiments and features in the embodiments of this application can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and embodiments.

It should be noted that, unless otherwise specified, all technical and scientific terms used in this application have the same meanings commonly understood by those of ordinary skill in the technical field to which this application belongs.

In the present invention, unless otherwise specified, the directional words used such as "up, down, top, bottom" usually refer to the direction shown in the drawings, or refer to the vertical or vertical position of the component itself. Vertically or in the direction of gravity; similarly, for ease of understanding and description, "inside and outside" refers to the inside and outside relative to the outline of each component itself, but the above directional terms are not used to limit the present invention.

Obviously, the above-described embodiments are only part of the embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts should fall within the scope of protection of the present invention.

In order to solve the problem in the prior art that the support effect of the lumen flow regulator is poor, the present invention provides a lumen flow regulator and a coronary sinus constriction device. Among them, the coronary sinus constriction device described below includes the following lumen flow regulator.

As shown in Figures 1 to 5, the lumen flow regulator includes an inner mesh 10 and an outer mesh 20 that are nested. Both the inner mesh 10 and the outer mesh 20 are made of elastic wire. The third end 21 of the outer mesh 20 is connected to the first end 11 of the inner mesh 10. The inner mesh 10 extends along the axial direction to form a lumen channel, and the inner mesh 10 gradually recesses inward from the two ends toward each other to form a reduced diameter. Section 30. The lumen flow regulator has a storage state and a release state. In the storage state, the outer mesh 20 is separated from the outer surface of the inner mesh 10 and extends sequentially along the axial direction with the inner mesh 10; when it is switched from the storage state to the release state At this time, the fourth end 22 of the outer mesh 20 is folded outward and gradually approaches the second end 12 of the inner mesh 10 until the outer mesh 20 and the inner mesh 10 are completely attached. It can be understood that the inner network 10 and the outer network 20 in this embodiment are formed by folding an entire single-layer network structure into a nested double-layer network structure. That is to say, the outer network 20 The third end 21 and the first end 11 of the inner network 10 are originally connected in sequence.

The throttling adjustment is achieved by setting the reduced diameter section 30, which increases the back pressure and improves the ratio of epicardial and subendocardial blood flow perfusion. The lumen flow regulator has a single-layer mesh form and a double-layer mesh form. The double-layer mesh form The structure can enhance the radial support force of the lumen flow regulator, thereby improving the support effect of the lumen flow regulator. The single-layer mesh form can reduce the diameter of the delivery sheath as much as possible during the sheath retraction and delivery process, reducing the need for Damage that may occur during the delivery process of the lumen flow regulator. In addition, because the inner mesh 10 and the outer mesh 20 are both made of elastic wire, they can automatically restore from a single mesh form to a double mesh shape during the release process based on the metal memory properties. In the layered network state, the lumen flow regulator can be released without other components, which is convenient and fast.

The way in which the outer mesh 20 and the inner mesh 10 cooperate in this embodiment can be analogous to the way people take off their gloves in real life.

In this embodiment, both the inner mesh 10 and the outer mesh 20 are woven from elastic wires. The elastic wire has shape memory. No balloon expansion is required after implantation of the luminal flow regulator, which simplifies the surgical procedure. Moreover, the braided mesh structure can protect the blood vessel wall to a certain extent during the implantation process. The luminal flow regulator is During the release process, there will be no point where a large impact force will occur to scratch or even puncture the blood vessel wall. Furthermore, since switching the lumen flow regulator from the storage state to the release state requires folding the layer mesh, the elastic metal braided mesh has high flexibility, allowing the lumen flow regulator to smoothly switch between single and double-layer mesh structures. Specifically, the elastic wire in this embodiment is a nickel-titanium alloy or other medical memory metal that is harmless to the human body. Even if it is left in the patient's body for a long time, it will not have an adverse effect on the human body. It not only achieves the purpose of treatment but also does not cause damage to the human body. It will bring inconvenience to patients’ daily life such as going through security check and general medical examination.

In this embodiment, the fourth end 22 of the outer mesh 20 has an inwardly bent edge, thereby forming a rounded end to minimize stimulation and damage to the blood vessel wall caused by the release of the lumen flow regulator. That is to say, during the process of switching from the storage state to the release state, the fourth end 22 of the outer mesh 20 is folded outward and moves along the outer surface of the inner mesh 10 to finally reach the second end of the inner mesh 10 12. The rounded edge end will not scratch the blood vessel wall during movement. Furthermore, the second end 12 of the inner mesh 10 also has an inwardly bent edge, so that the second end 12 of the inner mesh 10 will not cause damage to the blood vessel wall during the release process. Specifically, bending inward means bending in the direction of the central axis of the lumen flow regulator.

As shown in Figure 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 respectively connected with the reduced diameter section 30 in sequence, and the first expansion section 40 has The inner diameter is larger than the inner diameter of the second expansion section 50 . That is to say, the overall structure of the released lumen flow regulator is a double trumpet shape of "one large and one small". When the lumen flow regulator is installed at a designated position, when blood flows through the lumen flow regulator, it first enters the first expansion section 40, then throttles at the diameter reduction section 30, and then enters the second expansion section 50, and then Continue to flow downward, thereby increasing back pressure, improving the ratio of epicardial and subendocardial blood perfusion, and increasing the flow of oxygen-rich blood to the heart area where blood flow was previously abnormal, thereby achieving the purpose of alleviating myocardial ischemia.

In this embodiment, the reduced diameter section 30 is located at a central position between the first end 11 of the inner layer mesh 10 and the second end 12 of the inner layer mesh 10 . Through the above settings, the length of the blood flowing through the reduced diameter section 30 is kept consistent, making the blood flow rate change more smoothly and achieving a better throttling effect. Of course, the reduced diameter section 30 can also be closer to the second end 12 of the inner layer net 10 relative to the first end 11 of the inner layer net 10 , or the reduced diameter section 30 can be close to the inner layer relative to the second end 12 of the inner layer net 10 The first end 11 of the network 10 can be selected according to actual needs.

As shown in FIGS. 2 to 5 , the lumen flow regulator further includes a connecting piece 60 . The connecting piece 60 is provided at the second end 12 of the inner mesh 10 for connecting with the conveying assembly 70 .

As shown in Figures 2 to 5, the present invention also provides a coronary sinus constriction device, which includes a delivery component 70 and the above-mentioned lumen flow regulator. The lumen flow regulator is removably connected to the delivery assembly 70.

As shown in FIGS. 2 to 5 , the delivery assembly 70 includes a delivery cable 71 and a delivery sheath 72 . The delivery cable 71 is detachably connected to the connector 60 of the lumen flow regulator. The lumen flow regulator is housed within delivery sheath 72.

In this embodiment, the transmission steel cable 71 and the connector 60 are threaded. The conveying steel cable 71 is provided with external threads, and the connector 60 is provided with internal threads that match the external threads of the conveying steel cable 71 . The delivery steel cable 71 is connected to the lumen flow regulator through the connector 60, so that the lumen flow regulator can be adjusted accordingly before the lumen flow regulator is completely separated from the delivery sheath 72 to avoid damage to the lumen due to improper operation. The premature release or release position of the flow regulator beyond the designated location causes the lumen flow regulator to be unable to achieve its intended function. During the release process, medical staff can adjust the release degree and release position of the luminal flow regulator at any time, reducing intraoperative risks and the difficulty of emergency response.

The specific process of using the coronary sinus constriction device in this embodiment is as follows:

First, the luminal flow regulator is placed in the delivery sheath 72 of the delivery assembly 70 and connected by connecting the delivery cable 71 to the connector 60 . In the stowed state, the lumen flow regulator is completely accommodated in the delivery sheath 72 and the outer mesh 20 of the lumen flow regulator is separated from the outer surface of the inner mesh 10 of the lumen flow regulator and connected with the inner mesh 10 Extending sequentially along the axial direction, that is to say, the lumen flow regulator in the stowed state is a fully extended single-layer mesh structure. Then move the luminal flow regulator to the lesion. When switching from the storage state to the release state, the delivery sheath 72 gradually retracts so that the fourth end 22 of the outer mesh 20 gradually extends out of the delivery sheath 72, and the fourth end 22 of the outer mesh 20 is folded outward and Gradually approach the second end 12 of the inner mesh 10 . When the lumen flow regulator is completely separated from the delivery sheath 72, the outer mesh 20 and the inner mesh 10 are completely attached. That is to say, as the delivery sheath 72 gradually withdraws, the outer mesh 20 is gradually exposed to the delivery sheath 72 to release the constraints on the lumen flow regulator. Due to the shape memory effect and the movement of the delivery steel cable 71 Under pulling, the lumen flow regulator will gradually return to its original state, that is, it will return from a single-layer mesh structure to a double-layer mesh structure. After the lumen flow regulator returns to the double-layer mesh structure, the connection between the delivery steel cable 71 and the connector 60 is released, so that the lumen flow regulator is detached from the delivery component 70 and supported and fixed at the lesion, and then the delivery component 70 is removed from the It is extracted from the human body to complete the entire release process.

Furthermore, before the intraluminal flow regulator is completely separated from the delivery sheath 72, if the position of the instrument is not ideal or there are other circumstances, the delivery cable 71 can be withdrawn backward or the delivery sheath 72 can be pushed to adjust the intraluminal flow rate. The regulator is recycled and released.

From the above description, it can be seen that the above-mentioned embodiments of the present invention achieve the following technical effects: throttling adjustment is achieved by setting the reduced diameter section 30 to increase the back pressure and improve the epicardial and subendocardial blood flow. Perfusion ratio, the lumen flow regulator has a single-layer mesh form and a double-layer mesh form. The double-layer mesh structure can enhance the radial support force of the lumen flow regulator, thereby improving the support effect of the lumen flow regulator. The single-layer mesh structure can enhance the radial support force of the lumen flow regulator. The shape can reduce the diameter of the delivery sheath as much as possible during the sheath retraction and delivery process, thereby reducing possible damage during the delivery process of the lumen flow regulator. In addition, since both the inner mesh 10 and the outer mesh 20 are made of elastic Wire material, so that it can automatically return from a single-layer mesh form to a double-layer mesh state during the release process based on the metal memory properties. The release of the lumen flow regulator can be achieved without other components, which is convenient and fast.

It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, the singular forms are also intended to include the plural forms unless the context clearly indicates otherwise. Furthermore, it will be understood that when the terms "comprises" and/or "includes" are used in this specification, they indicate There are features, steps, work, means, components and/or combinations thereof.

It should be noted that the terms "first", "second", etc. in the description and claims of this application and the above-mentioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It is to be understood that the data so used are interchangeable under appropriate circumstances so that the embodiments of the application described herein can be practiced in sequences other than those illustrated or described herein.

The above descriptions are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and changes. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention shall be included in the protection scope of the present invention.

Claims (9)

1. A lumen flow regulator, characterized by comprising an inner network (10) and an outer network (20) arranged in a nested manner, the inner network (10) and the outer network (20) They are all made of elastic wire. The third end (21) of the outer mesh (20) is connected to the first end (11) of the inner mesh (10). The inner mesh (10) is The axial extension forms a lumen channel, and the inner mesh (10) gradually recesses inward from the two ends toward each other to form a reduced diameter section (30); The lumen flow regulator has a storage state and a release state. In the storage state, the outer mesh (20) is separated from the outer surface of the inner mesh (10) and connected with the inner mesh (10). ) extends sequentially along the axial direction; when switching from the storage state to the release state, the fourth end (22) of the outer mesh (20) is folded outward and gradually approaches the inner mesh ( The second end (12) of 10) until the outer mesh (20) and the inner mesh (10) are completely attached; The luminal flow regulator also includes a connecting piece (60), which is provided at the second end (12) of the inner mesh (10) and is used for delivery with the coronary sinus constriction device. Component (70) connection. 2. The lumen flow regulator according to claim 1, characterized in that the inner mesh (10) and the outer mesh (20) are both 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 mesh (10) has an inwardly bent edge. 5. The luminal flow regulator according to claim 1, wherein the luminal channel includes a first expansion section (40) and a second expansion section (50), and the first expansion section (40) and the second expansion section (50) are respectively connected with the diameter reduction section (30) in sequence, and the inner diameter of the first expansion section (40) is greater than the inner diameter of the second expansion section (50). 6. The lumen flow regulator according to claim 1, characterized in that, The reduced diameter section (30) is located at the center between the first end (11) and the second end (12) of the inner mesh (10); or The reduced diameter section (30) is close to the second end (12) of the inner mesh (10) relative to the first end (11) of the inner mesh (10); or The reduced diameter section (30) is close to the first end (11) of the inner layer net (10) relative to the second end (12) of the inner layer net (10). 7. A coronary sinus constriction device, characterized by comprising a delivery component (70) and the luminal flow regulator according to any one of claims 1 to 6, the luminal flow regulator being in contact with the delivery component The components (70) are removably connected. 8. The coronary sinus constriction device according to claim 7, wherein the delivery assembly (70) includes: Conveying steel cable (71), the conveying steel cable (71) is detachably connected to the connector (60) of the lumen flow regulator; A delivery sheath (72) within which the lumen flow regulator is housed. 9. The coronary sinus constriction device according to claim 8, characterized in that, in the stowed state, the lumen flow regulator is completely accommodated in the delivery sheath (72) and the tube The outer mesh (20) of the lumen flow regulator is separated from the outer surface of the inner mesh (10) of the lumen flow adjuster and extends sequentially along the axial direction with the inner mesh (10); when it is formed by the When the storage state is switched to the release state, the delivery sheath (72) gradually withdraws so that the fourth end (22) of the outer mesh (20) gradually extends out of the delivery sheath (72), The fourth end (22) of the outer mesh (20) is folded outward and gradually approaches the second end (12) of the inner mesh (10), and the lumen flow regulator is completely separated from the conveyor When the sheath tube (72) is sheathed, the outer mesh (20) and the inner mesh (10) are completely attached.