Lumen flow regulator and coronary sinus constriction device

Abstract

The utility model provides a kind of lumen flow regulator and coronary sinus constriction device. Lumen flow regulator includes layer net structure, and layer net structure forms lumen passage along axial extension, and lumen passage includes first expansion part, narrowing part and second expansion part connected in turn, and the inner diameter of first expansion part and second expansion part is all greater than the inner diameter of narrowing part, wherein, narrowing part includes main body section and transition section located at both ends of main body section, two transition sections are connected with first expansion part and second expansion part respectively, and the mesh size of transition section is greater than the mesh size of main body section and the mesh size of first expansion part and second expansion part. The utility model solves the problem of poor postoperative adaptability of lumen flow regulator in the prior art.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to a lumen flow regulator and a coronary sinus constriction device. Background Technology

[0002] Angina pectoris is a clinical syndrome characterized by paroxysmal chest pain or discomfort, caused by insufficient blood supply to the coronary arteries and acute, temporary ischemia and hypoxia of the myocardium. Angina pectoris is pain felt on the body surface as a reflection of ischemic heart disease; it is characterized by paroxysmal, squeezing pain in the anterior chest, which may be accompanied by other symptoms. The pain is mainly located behind the sternum and can radiate to the precordial region and left upper limb. The direct cause of angina pectoris is insufficient blood supply to the myocardium, which is usually a symptom of coronary artery disease.

[0003] Of all patients with angina, an estimated 10% suffer from severe, persistent symptoms that cannot be controlled by conventional medical therapies. This severe debilitating condition is known as refractory angina. Lumen flow regulators are considered a promising solution for treating refractory angina. Their mechanism of action involves establishing an interventional pathway via minimally invasive surgery. The flow regulator is delivered through this pathway across the right atrium to the coronary sinus implantation site, narrowing the coronary sinus diameter, establishing a transsinus pressure gradient, increasing back pressure, improving the ratio of epicardial and subendocardial blood perfusion, and increasing the flow of oxygen-rich blood to previously abnormal areas of the heart, thereby alleviating myocardial ischemia.

[0004] Existing lumen flow regulators are generally hourglass-shaped structures with two ends for support and a narrow section in the middle for throttling. However, the pores in the narrow section of existing lumen flow regulators are small, resulting in a greater obstruction of blood flow after implantation. This can cause patients to experience discomfort immediately after implantation, thus affecting their postoperative adaptation.

[0005] As can be seen from the above, the existing technology has the problem of poor postoperative adaptability of lumen flow regulators. Utility Model Content

[0006] The main purpose of this invention is to provide a lumen flow regulator and a coronary sinus constriction device to solve the problem of poor postoperative adaptability of lumen flow regulators in the prior art.

[0007] To achieve the above objectives, according to one aspect of the present invention, a lumen flow regulator is provided, comprising a layered mesh structure extending axially to form a lumen channel. The lumen channel includes a first expansion portion, a narrowing portion, and a second expansion portion connected sequentially. The inner diameters of the first expansion portion and the second expansion portion are both larger than the inner diameter of the narrowing portion. The narrowing portion includes a main body section and transition sections located at both ends of the main body section. The two transition sections are respectively connected to the first expansion portion and the second expansion portion, and the mesh size of the transition sections is larger than the mesh size of the main body section and the mesh size of the first expansion portion and the second expansion portion.

[0008] Furthermore, the end of the transition section has a connecting pin extending toward the first expansion portion or the second expansion portion. There are multiple connecting pins, which are spaced apart circumferentially along the transition section and connected to the first expansion portion or the second expansion portion.

[0009] Furthermore, the layered structure is woven from interlaced elastic filaments, wherein the connecting pin is formed by at least two strands of elastic filaments wound together.

[0010] Furthermore, the transition section is an arc shape whose inner diameter gradually decreases along the direction closer to the main body section.

[0011] Furthermore, the inner diameter of the first expansion portion is larger than the inner diameter of the second expansion portion.

[0012] Furthermore, the layered structure is made of interwoven elastic filaments.

[0013] Furthermore, the elastic filament is a shape memory metal material.

[0014] According to another aspect of the present invention, a coronary sinus constriction device is provided, comprising the above-described lumen flow regulator.

[0015] Furthermore, the coronary sinus constriction device also includes a delivery assembly, with the lumen flow regulator detachably connected to the delivery assembly.

[0016] Furthermore, the delivery assembly includes: a delivery cable detachably connected to the lumen flow regulator; and a delivery sheath in which the lumen flow regulator is housed.

[0017] The present invention provides a lumen flow regulator comprising a layered mesh structure extending axially to form a lumen channel. The lumen channel includes a first expansion section, a narrowing section, and a second expansion section connected sequentially. The inner diameters of both the first and second expansion sections are larger than the inner diameter of the narrowing section. The narrowing section includes a main body segment and transition sections at both ends of the main body segment. The two transition sections are connected to the first and second expansion sections respectively, and the mesh size of the transition sections is larger than that of the main body segment, the first expansion section, and the second expansion section. By setting the transition sections at both ends of the narrowing section to have relatively large mesh sizes, the lumen flow regulator initially causes less obstruction to blood flow, preventing significant stress responses in patients. As the narrowing section gradually becomes endothelialized, the obstruction effect of the lumen flow regulator on blood flow gradually increases, and the therapeutic effect becomes more pronounced. This allows for a longer postoperative adaptation period for patients, greatly improving their postoperative recovery experience and solving the problem of poor postoperative adaptability of existing lumen flow regulators. Attached Figure Description

[0018] The accompanying drawings, which form 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 undue limitation of the present invention. In the drawings:

[0019] Figure 1 A schematic diagram of the structure of a lumen flow regulator in a specific embodiment of the present invention is shown;

[0020] Figure 2 A partially enlarged view of the transition section in a specific embodiment of the present invention is shown.

[0021] The above figures include the following reference numerals:

[0022] 10. First dilatation section; 20. Narrowing section; 21. Main body section; 22. Transition section; 221. Connecting pin; 30. Second dilatation section; 40. Blood vessel wall. Detailed Implementation

[0023] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0024] It should be noted that, unless otherwise specified, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0025] In this utility model, unless otherwise stated, directional terms such as "upper," "lower," "top," and "bottom" are generally used in relation to the direction shown in the accompanying drawings, or in relation to the vertical, perpendicular, or gravitational direction of the component itself; similarly, for ease of understanding and description, "inner" and "outer" refer to the inner and outer contours of each component itself, but the above directional terms are not used to limit this utility model.

[0026] Obviously, the embodiments described above are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort should fall within the protection scope of this utility model.

[0027] To address the problem of poor postoperative adaptability of existing lumen flow regulators, this invention provides a lumen flow regulator and a coronary sinus constriction device. The coronary sinus constriction device includes the lumen flow regulator described below.

[0028] like Figure 1 As shown, the lumen flow regulator includes a layered mesh structure that extends axially to form a lumen channel. The lumen channel includes a first expansion section 10, a narrowing section 20, and a second expansion section 30 connected in sequence. The inner diameters of the first expansion section 10 and the second expansion section 30 are both larger than the inner diameter of the narrowing section 20. The narrowing section 20 includes a main body section 21 and transition sections 22 located at both ends of the main body section 21. The two transition sections 22 are respectively connected to the first expansion section 10 and the second expansion section 30, and the mesh size of the transition section 22 is larger than the mesh size of the main body section 21 and the mesh size of the first expansion section 10 and the second expansion section 30.

[0029] By configuring the lumen flow regulator with a layered mesh structure that extends axially to form a lumen channel, the lumen channel includes a first expansion section 10, a narrowing section 20, and a second expansion section 30 connected sequentially. The inner diameters of the first expansion section 10 and the second expansion section 30 are both larger than the inner diameter of the narrowing section 20. The narrowing section 20 includes a main body section 21 and transition sections 22 located at both ends of the main body section 21. The two transition sections 22 are connected to the first expansion section 10 and the second expansion section 30, respectively. The mesh size of the transition sections 22 is larger than that of the main body section 21 and the first expansion section 10 and the second expansion section 30. By setting the transition sections 22 at both ends of the narrowing section 20 to have relatively large mesh sizes, the lumen flow regulator causes less obstruction to blood flow when it is first implanted, preventing a large stress response in the patient. As the narrowing section 20 gradually becomes endothelialized, the obstruction effect of the lumen flow regulator on blood flow gradually increases, and the therapeutic effect gradually becomes more obvious. This allows the patient a longer postoperative adaptation period and greatly improves the patient's postoperative recovery experience.

[0030] In this embodiment, the inner diameter of the first expansion portion 10 is larger than the inner diameter of the second expansion portion 30. That is, the overall structure of the released lumen flow regulator is a double-horn shape or hourglass shape with one large and one small component. Figure 1 As shown, when the lumen flow regulator is released and installed in the designated position, the first expansion section 10 and the second expansion section 30 are supported and attached to the blood vessel wall 40. When blood flows through the lumen flow regulator, it first enters the second expansion section 30, then undergoes throttling regulation at the narrowing section 20 before entering the first expansion section 10, and then continues to flow downwards, thereby increasing back pressure, improving the ratio of epicardial and subendocardial blood perfusion, and increasing the flow of oxygen-rich blood to previously abnormal cardiac areas, thereby achieving the purpose of relieving myocardial ischemia.

[0031] In this embodiment, the narrowing portion 20 is located at the center of the lumen flow regulator. This arrangement ensures that the length of blood flowing through the narrowing portion 20 remains consistent, resulting in a smoother blood flow rate and a better throttling effect. Alternatively, the narrowing portion 20 can be positioned closer to the second expansion portion 30 relative to the first expansion portion 10, or vice versa; the choice can be made based on actual needs.

[0032] In this embodiment, at least a portion of the first expansion portion 10 is a smooth section with an equal inner diameter, and further, the smooth section is located at the end of the first expansion portion 10. Correspondingly, the second expansion portion 30 can also adopt the above configuration, which will not be described in detail here. With the above configuration, the smooth section can fit against the blood vessel wall 40, so that the lumen flow regulator fits better against the blood vessel wall 40 and prevents displacement.

[0033] In this embodiment, the layered mesh structure is woven from interlaced elastic filaments. Specifically, the elastic filaments are shape memory metal materials, which have shape memory properties, allowing the flow regulator in the lumen to automatically return to its original shape during release, making it convenient and quick.

[0034] In this embodiment, the elastic filament can be a nickel-titanium alloy. Of course, the elastic filament can also be other medical shape memory metal materials that are harmless to the human body, possess excellent biocompatibility, and have good safety even after long-term implantation in the human body. It can achieve the purpose of treatment without causing inconvenience to the patient's daily life, such as going through security checks or general medical examinations. It can be selected according to actual needs.

[0035] More specifically, in this embodiment, the layered mesh structure is woven from a single elastic filament. This ensures that the entire flow regulator is made of interwoven elastic filaments, without any breaks or joints, resulting in high structural strength and stability.

[0036] In this embodiment, the transition section 22 is an arc shape whose inner diameter gradually decreases along the direction close to the main body section 21. Furthermore, the connection points between the first expansion section 10 and the second expansion section 30 and the narrowing section 20 are also arc shapes whose inner diameter gradually decreases along the direction close to the narrowing section 20, and are sequentially connected to the transition section 22 respectively. This makes the connection between the narrowing section 20 and the first expansion section 10 and the second expansion section 30 relatively smooth. With the total length of the lumen flow regulator remaining constant, the first expansion section 10 and the second expansion section 30 have a longer adjustable distance, thereby providing a stable radial support and fixation effect within the blood vessel.

[0037] Furthermore, such as Figure 2 As shown, the end of the transition section 22 has connecting pins 221 extending toward the first expansion portion 10 or the second expansion portion 30. Multiple connecting pins 221 are arranged at circumferential intervals along the transition section 22 and connect to the first expansion portion 10 or the second expansion portion 30. It is understood that there are mesh openings between adjacent connecting pins 221. This arrangement results in a single-row mesh at the transition section 22, which, compared to the denser woven mesh structure in other parts, has a larger mesh size and better bending performance.

[0038] In this embodiment, as Figure 2 As shown, the connecting pin 221 is made of at least two strands of elastic filaments wound together. That is to say, the connecting pin 221 is a braided structure similar to a twisted rope.

[0039] This application also provides a coronary sinus constriction device, including the aforementioned lumen flow regulator. Furthermore, the coronary sinus constriction device further includes a delivery assembly, and the lumen flow regulator is detachably connected to the delivery assembly.

[0040] In this embodiment, the delivery assembly includes a delivery cable and a delivery sheath. The delivery cable is detachably connected to a lumen flow regulator. The lumen flow regulator is housed within the delivery sheath.

[0041] In this embodiment, the lumen flow regulator also includes a connector disposed at the end of the first expansion portion 10, and the delivery cable is threadedly connected to the connector. The delivery cable has an external thread, and the connector has an internal thread that matches the external thread of the delivery cable. The delivery cable is connected to the lumen flow regulator via the connector, allowing for adjustments to the lumen flow regulator before it is completely detached from the delivery sheath. This prevents premature release or release beyond the designated location due to improper operation, thus avoiding the lumen flow regulator failing to perform its intended function. During the release process, medical staff can adjust the degree and position of the lumen flow regulator's release at any time, reducing intraoperative risks and the difficulty of emergency response.

[0042] The specific usage process of the coronary sinus constriction device in this embodiment is as follows:

[0043] First, the flow regulator is placed inside the delivery sheath by connecting the delivery cable to the connector. In the retracted state, the flow regulator is completely contained within the delivery sheath and compressed into an elongated shape, minimizing the size of the delivery sheath and reducing vascular damage caused by establishing the delivery pathway. The flow regulator is then moved to the target location. When switching from the retracted state to the release state, the delivery sheath gradually retracts, allowing one end of the flow regulator to extend out of the sheath and, due to its metal memory properties, return to its second expansion portion 30. As the delivery sheath gradually retracts, the flow regulator gradually protrudes from the sheath, continuing to return to its narrowed portion 20 and first expansion portion 10, gradually restoring the flow regulator to its original state. Once the flow regulator has returned to its original state, the connection between the delivery cable and the connector is released, allowing the flow regulator to detach from the delivery assembly and be supported and fixed at the target location. The delivery assembly is then withdrawn from the patient, completing the entire release process.

[0044] Furthermore, if the instrument is not in an ideal position or there are other issues before the flow regulator in the lumen is completely detached from the delivery sheath, the flow regulator in the lumen can be retrieved and released by retracting the delivery cable or pushing the delivery sheath backward.

[0045] From the above description, it can be seen that the above embodiments of this utility model achieve the following technical effects: by setting the lumen flow regulator to include a layered mesh structure, the layered mesh structure extends axially to form a lumen channel, the lumen channel includes a first expansion portion 10, a narrowing portion 20, and a second expansion portion 30 connected in sequence, the inner diameters of the first expansion portion 10 and the second expansion portion 30 are both larger than the inner diameter of the narrowing portion 20, wherein the narrowing portion 20 includes a main body section 21 and transition sections 22 located at both ends of the main body section 21, the two transition sections 22 are respectively connected to the first expansion portion 10 and the second expansion portion 30, and The mesh size of the transition section 22 is larger than that of the main body section 21, as well as the mesh size of the first expansion section 10 and the second expansion section 30. By setting the transition sections 22 at both ends of the narrowing section 20 to have relatively large mesh sizes, the obstruction to blood flow by the lumen flow regulator is small when it is first implanted, preventing the patient from experiencing a large stress response. As the narrowing section 20 gradually becomes endothelialized, the obstruction to blood flow by the lumen flow regulator gradually increases, and the therapeutic effect gradually becomes more obvious. This allows the patient to have a longer postoperative adaptation period and greatly improves the patient's postoperative recovery experience.

[0046] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0047] It should be noted that the terms "first," "second," etc., used in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this application described herein can be implemented in sequences other than those illustrated or described herein.

[0048] The above description is merely a preferred embodiment of this utility model and is not intended to limit the utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A lumen flow regulator, characterized in that, The system includes a layered network structure that extends axially to form a tubular channel. The tubular channel comprises a first expansion portion (10), a narrowing portion (20), and a second expansion portion (30) connected sequentially. The inner diameters of both the first expansion portion (10) and the second expansion portion (30) are larger than the inner diameter of the narrowing portion (20). The narrowing section (20) includes a main body section (21) and transition sections (22) located at both ends of the main body section (21). The two transition sections (22) are respectively connected to the first expansion section (10) and the second expansion section (30), and the mesh size of the transition section (22) is larger than the mesh size of the main body section (21) and the mesh size of the first expansion section (10) and the second expansion section (30).

2. The lumen flow regulator according to claim 1, characterized in that, The end of the transition section (22) has a connecting pin (221) extending toward the first expansion portion (10) or the second expansion portion (30). There are multiple connecting pins (221), which are spaced apart circumferentially along the transition section (22) and connected to the first expansion portion (10) or the second expansion portion (30).

3. The lumen flow regulator according to claim 2, characterized in that, The layered mesh structure is woven from interlaced elastic filaments, wherein the connecting pin (221) is formed by winding at least two strands of the elastic filaments.

4. The lumen flow regulator according to claim 1, characterized in that, The transition section (22) is an arc shape whose inner diameter gradually decreases along the direction close to the main body section (21).

5. The lumen flow regulator according to claim 1, characterized in that, The inner diameter of the first expansion portion (10) is larger than the inner diameter of the second expansion portion (30).

6. The lumen flow regulator according to claim 1, characterized in that, The layered mesh structure is made of elastic filaments interwoven together.

7. The lumen flow regulator according to claim 6, characterized in that, The elastic filament is a shape memory metal material.

8. A coronary sinus constriction device, characterized in that, Includes the lumen flow regulator according to any one of claims 1 to 7.

9. The coronary sinus constriction device according to claim 8, characterized in that, The coronary sinus constriction device also includes a delivery assembly, and the lumen flow regulator is detachably connected to the delivery assembly.

10. The coronary sinus constriction device according to claim 9, characterized in that, The conveying assembly includes: A conveying steel cable, wherein the conveying steel cable is detachably connected to the lumen flow regulator; A delivery sheath, wherein the lumen flow regulator is housed within the delivery sheath.

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