Lumen flow regulator and coronary sinus constriction device

Abstract

The utility model provides a lumen flow regulator and a coronary sinus constriction device. The lumen flow regulator comprises a layer net structure, the layer net structure is made of elastic wires, the layer net structure extends in the axial direction to form a lumen channel, the lumen channel comprises a first expansion section, a reducing section and a second expansion section which are sequentially connected, and the inner diameter of the first expansion section and the inner diameter of the second expansion section are both larger than the inner diameter of the reducing section. A hanging lug structure is arranged at the end of the first expansion section, and at least one part of a conveying steel cable of the coronary sinus constriction device extends into the hanging lug structure and is limited and blocked with the hanging lug structure, so that the lumen flow regulator is detachably connected with the conveying steel cable. The coronary sinus constriction device solves the problem that a coronary sinus constriction device in the prior art is inconvenient to use.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a lumen flow regulator and a coronary sinus constriction device. Background Art

[0002] Angina pectoris is a clinical syndrome characterized by paroxysmal chest pain or chest discomfort caused by insufficient blood supply to the coronary arteries, acute temporary myocardial ischemia and hypoxia. Angina pectoris is the pain felt when cardiac ischemia is reflected on the surface of the body. 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 area 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 symptoms that are severe, persistent, and uncontrollable with conventional medical therapies. This severe, debilitating condition is known as refractory angina. The coronary sinus constriction device is considered a promising solution for the treatment of refractory angina. Its working principle is: through minimally invasive surgery to establish an interventional pathway, the coronary sinus constriction device is delivered through the pathway through the right atrium to the coronary sinus implantation site, narrowing the inner diameter of the coronary sinus, establishing a trans-sinus pressure gradient, increasing back pressure, improving the ratio of epicardial and subendocardial blood perfusion, and increasing oxygen-rich blood flow to previously abnormal heart areas, thereby relieving myocardial ischemia.

[0004] Current coronary sinus constriction devices are generally made of a medical stainless steel cut frame that is expanded with a balloon. The device is delivered to the target location through a delivery device and expanded with a balloon to make it fit closely to the blood vessel wall, narrow the inner diameter of the coronary sinus, increase back pressure, and improve blood perfusion ratio. The delivery device that uses balloon expansion needs to be pre-installed with the instrument, the procedure is cumbersome, and it increases the operating steps and time of medical staff, which brings great inconvenience and increases the preparation time for surgery.

[0005] As can be seen from the above, the coronary sinus constriction device in the prior art is inconvenient to use. Utility Model Content

[0006] The main purpose of the utility model is to provide a lumen flow regulator and a coronary sinus constriction device to solve the problem that the coronary sinus constriction device in the prior art is inconvenient to use.

[0007] In order to achieve the above-mentioned purpose, according to one aspect of the utility model, a tubular cavity flow regulator is provided, including a layer mesh structure, the layer mesh structure is made of elastic wire material, the layer mesh structure extends axially to form a tubular cavity channel, the tubular cavity channel includes a first expansion section, a reduction section and a second expansion section connected in sequence, the inner diameter of the first expansion section and the inner diameter of the second expansion section are both larger than the inner diameter of the reduction section, and an ear structure is provided at the end of the first expansion section, at least a part of the delivery cable of the coronary sinus narrowing device extends into the ear structure and is limited by the ear structure, so that the tubular cavity flow regulator is detachably connected to the delivery cable.

[0008] Furthermore, the hanging ear structure includes a plurality of hanging ears, and the plurality of hanging ears are arranged at intervals along the circumferential direction of the first expansion section.

[0009] Furthermore, the hanging ear is a single wire structure or a multi-wire spirally wound structure made of elastic wire material.

[0010] Furthermore, the hanging ear comprises a first extension section, a curved section and a second extension section which are connected in sequence, the first extension section and the second extension section are respectively connected to the first expansion section, and the curved section is a rounded arc.

[0011] Furthermore, the ear-hanging structure and the layer net structure are woven integrally from a whole elastic wire; or the ear-hanging structure and the layer net structure are bonded; or the ear-hanging structure and the layer net structure are welded.

[0012] According to another aspect of the utility model, a coronary sinus constriction device is provided, comprising a delivery component and the above-mentioned lumen flow regulator, wherein the lumen flow regulator and the delivery component are detachably connected.

[0013] Furthermore, the delivery component includes: a delivery steel cable, on which a connector is provided, and the connector is detachably connected to the ear structure; and a delivery sheath, in which the lumen flow regulator is accommodated.

[0014] Furthermore, the connecting piece has a limiting protrusion which radially protrudes from the outer surface of the connecting piece, and the limiting protrusion extends into the hanging ear structure and the hanging ear structure limiting stop.

[0015] Furthermore, the connecting piece has an annular main body portion, which is sleeved on the conveying steel cable, and the limiting protrusion protrudes radially from the outer surface of the annular main body portion.

[0016] Furthermore, there are multiple limiting protrusions, and the multiple limiting protrusions are arranged in a one-to-one correspondence with the multiple hanging ears of the hanging ear structure.

[0017] By applying the technical solution of the utility model, the lumen flow regulator includes a layered mesh structure, which is made of elastic wire material. The layered mesh structure extends axially to form a lumen channel. The lumen channel includes a first expansion section, a diameter reduction section, and a second expansion section connected in sequence. The inner diameter of the first expansion section and the inner diameter of the second expansion section are both larger than the inner diameter of the diameter reduction section. An ear structure is provided at the end of the first expansion section. At least a portion of the delivery cable of the coronary sinus constriction device extends into the ear structure and is limited by the ear structure so that the lumen flow regulator is detachably connected to the delivery cable. In this way, throttling regulation is achieved by providing the diameter reduction section, so that the back pressure rises. The invention has high elasticity, strong compliance, and is easy to use, and does not require balloon dilatation, which simplifies the surgical procedure. The elastic wire has shape memory properties, so that the lumen flow regulator can automatically restore to its original shape during the release process, which is convenient and quick. Furthermore, a hook structure is provided on the first expansion section, and the delivery steel cable is detachably connected to the hook structure, so that the lumen flow regulator can be withdrawn and adjusted before release and the lumen flow regulator can be recovered after release, thereby reducing intraoperative risks and the difficulty of emergency treatment, greatly improving the convenience of use of the coronary sinus constriction device, and solving the problem of inconvenient use of the coronary sinus constriction device in the prior art. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The drawings constituting part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation on the present invention. In the drawings:

[0019] Figure 1 A schematic structural diagram showing an angle of a lumen flow regulator in a specific embodiment of the utility model; and

[0020] Figure 2 A schematic structural diagram showing another angle of a lumen flow regulator in a specific embodiment of the utility model;

[0021] Figure 3 A schematic diagram showing the structure of a lumen flow regulator in a specific embodiment of the utility model in a stored state;

[0022] Figure 4 A schematic diagram of the structure of a conveying steel cable in a specific embodiment of the utility model is shown;

[0023] Figure 5 It shows a schematic structural diagram of the lumen flow regulator starting to release in a specific embodiment of the utility model;

[0024] Figure 6 A schematic structural diagram showing the completion of release of a lumen flow regulator in a specific embodiment of the utility model is shown.

[0025] The above drawings include the following reference numerals:

[0026] 10. First expansion section; 20. Reduced diameter section; 30. Second expansion section; 50. Hanging ear structure; 51. Hanging ear; 60. Delivery cable; 61. Connector; 611. Limiting protrusion; 70. Delivery sheath. DETAILED DESCRIPTION

[0027] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present utility model will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0028] It should be noted that, unless otherwise specified, all technical and scientific terms used in this application have the same meanings as commonly understood by ordinary technicians in the technical field to which this application belongs.

[0029] In the present invention, unless otherwise specified, the directional words used, such as "up, down, top, bottom", usually refer to the directions shown in the drawings, or to the components themselves in the vertical, perpendicular or gravity directions; similarly, for ease of understanding and description, "inside and outside" refer to the inside and outside relative to the outline of each component itself, but the above-mentioned directional words are not used to limit the present invention.

[0030] Obviously, the embodiments described above are only some embodiments of the utility model, not all embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the utility model.

[0031] In order to solve the problem that the coronary sinus constriction device in the prior art is inconvenient to use, the utility model provides a lumen flow regulator and a coronary sinus constriction device. The coronary sinus constriction device includes the lumen flow regulator.

[0032] like Figure 1 to Figure 2 As shown, the lumen flow regulator includes a layered mesh structure, which is made of elastic wire material, and the layered mesh structure extends axially to form a lumen channel. The lumen channel includes a first expansion section 10, a diameter reduction section 20, and a second expansion section 30 connected in sequence, and the inner diameter of the first expansion section 10 and the inner diameter of the second expansion section 30 are both larger than the inner diameter of the diameter reduction section 20. In other words, the overall structure of the lumen flow regulator is a double trumpet shape of "one large and one small". An ear hanging structure 50 is provided at the end of the first expansion section 10, and at least a portion of the delivery cable 60 of the coronary sinus constriction device extends into the ear hanging structure 50 and is limited by the ear hanging structure 50, so that the lumen flow regulator is detachably connected to the delivery cable 60.

[0033] By setting the reduced diameter section 20 to achieve throttling regulation, the back pressure is increased, the compliance is strong, the use is convenient, and no balloon dilation is required, which simplifies the surgical procedure. The elastic wire has shape memory properties, so that the lumen flow regulator can automatically return to its original shape during the release process, which is convenient and quick. Furthermore, by setting a hook structure 50 on the first expansion section 10, the delivery steel cable 60 is detachably connected to the hook structure 50, so that the lumen flow regulator can be withdrawn and adjusted before release and the lumen flow regulator can be recovered after release, thereby reducing intraoperative risks and the difficulty of emergency treatment, and greatly improving the ease of use of the coronary sinus narrowing device.

[0034] like Figures 1 to 6 As shown, the lug structure 50 includes a plurality of lugs 51, and the plurality of lugs 51 are arranged at intervals along the circumference of the first expansion section 10. Further, the plurality of lugs 51 are arranged at equal intervals along the circumference of the first expansion section 10, thereby improving the connection stability between the lug structure 50 and the conveying steel cable 60.

[0035] Specifically, the lug 51 is a multi-wire spiral winding structure made of elastic wire. In this embodiment, the lug 51 is a double-wire spiral winding structure. The above structure can improve the structural strength of the lug 51, thereby improving the connection stability between the lug structure 50 and the conveying cable 60. Of course, the lug 51 can also be a single wire structure made of elastic wire, which can be selected according to actual needs.

[0036] In this embodiment, the layer net structure is woven from a whole elastic wire. Further, in order to improve the overall strength of the structure, the ear hanging structure 50 and the layer net structure are woven from a whole elastic wire. In this way, the entire intraluminal flow regulator is woven from elastic wire without breakpoints and interfaces, and has high structural strength and stability.

[0037] In an optional embodiment, the ear hanging structure 50 is bonded to the layer net structure. Of course, the ear hanging structure 50 and the layer net structure can also be welded or connected in other ways, which can be selected according to actual needs.

[0038] In this embodiment, the elastic wire is nickel-titanium alloy or other filamentary shape memory metal materials. By setting the lumen flow regulator to be woven from elastic wire, it has strong compliance, does not require balloon dilatation, is easy to use, simplifies the procedure, and the woven mesh structure during implantation can reduce the risk of damaging blood vessels and play a certain protective role on the inner wall of the blood vessel.

[0039] In this embodiment, the ear 51 includes a first extension section, a curved section, and a second extension section connected in sequence, the first extension section and the second extension section are respectively connected to the first expansion section 10, and the curved section is a rounded arc. In other words, the ear 51 in this embodiment is arched. The rounded curved section can reduce damage to the inner wall of the blood vessel when the ear 51 fits against the inner wall of the blood vessel.

[0040] In this embodiment, the edges of the first expansion section 10 and the second expansion section 30 of the lumen flow regulator are rounded without sharp edges and corners, which reduces the risk of damage to human tissue during surgery. Blood passes through the first expansion section 10, the reduced diameter section 20 and the second expansion section 30 of the lumen flow regulator in sequence. Since the inner diameter of the reduced diameter section 20 is the smallest, a throttling effect will be generated at the reduced diameter section 20. By providing the reduced diameter section 20 to achieve throttling regulation, the back pressure is increased, the blood perfusion ratio of the epicardium and the endocardium is improved, and the oxygen-rich blood is increased to flow to the heart area with abnormal blood flow, thereby achieving the purpose of alleviating myocardial ischemia.

[0041] In this embodiment, at least a portion of the first expansion section 10 is a flat section with an equal inner diameter. Furthermore, the flat section is located at the end of the first expansion section 10 and is connected to the hanging ear 51. Correspondingly, the second expansion section 30 can also adopt the above-mentioned configuration, which will not be described in detail here. Through the above-mentioned configuration, the flat section can fit the inner wall of the blood vessel, so that the lumen flow regulator can better fit the inner wall of the blood vessel to prevent displacement.

[0042] In this embodiment, the lumen flow regulator also includes a flow-blocking membrane, which is arranged on the inner surface of the lumen flow regulator. Specifically, the shape of the flow-blocking membrane is adapted to the shape of the lumen channel, i.e., a double trumpet shape. Through the above arrangement, relying on the flow-blocking property of the flow-blocking membrane, the immediacy of the throttling effect of the lumen flow regulator during the operation can be enhanced. Furthermore, the flow-blocking membrane can also be arranged on the outer surface of the lumen flow regulator to reduce the stimulation to the target lumen, which can be selected according to actual needs.

[0043] The utility model also provides a coronary sinus constriction device, which comprises a conveying component and the above-mentioned lumen flow regulator, wherein the lumen flow regulator and the conveying component are detachably connected.

[0044] like Figures 3 to 6 As shown, the delivery assembly includes a delivery cable 60 and a delivery sheath 70. The delivery cable 60 is provided with a connector 61, which is detachably connected to the ear structure 50. The lumen flow regulator is accommodated in the delivery sheath 70.

[0045] Specifically, the connecting piece 61 is arranged in the middle position of the delivery cable 60 , and the delivery cable 60 partially extends into the lumen flow regulator, and the lumen flow regulator extends along the axial direction of the delivery cable 60 . At this time, the lumen flow regulator is compressed and completely received in the delivery sheath 70 .

[0046] like Figures 4 to 6 As shown, the connecting member 61 has a limiting protrusion 611 radially protruding from the outer surface of the connecting member 61 , and the limiting protrusion 611 extends into the hanging ear structure 50 and is limited by the hanging ear structure 50 .

[0047] Specifically, the limiting protrusion 611 and the ear 51 of the ear structure 50 are limited and stopped, and the ear 51 is suspended on the limiting protrusion 611. Since the tubular cavity flow regulator is compressed in the delivery sheath 70, the first expansion section 10 is also attached to the surface of the connecting piece 61. The ear 51 is limited along the axial direction of the delivery cable 60 by the limiting protrusion 611 to prevent the ear 51 from detaching from the delivery sheath along the axial direction of the delivery cable 60 during the operation. At the same time, in the process of releasing the tubular cavity flow regulator, the position of the moving tubular cavity flow regulator can be achieved by moving the delivery cable 60.

[0048] In this embodiment, the connector 61 has an annular main body, which is sleeved and fixed on the delivery cable 60. The limiting protrusion 611 protrudes radially from the outer surface of the annular main body. The edge of the limiting protrusion 611 is passivated, has no sharp edges, and will not cause damage to the inner wall of the blood vessel.

[0049] Specifically, there are multiple limiting protrusions 611, and the multiple limiting protrusions 611 are arranged in a one-to-one correspondence with the multiple hanging ears 51 of the hanging ear structure 50. In this embodiment, there are two limiting protrusions 611, and the two limiting protrusions 611 are arranged opposite to each other. Correspondingly, the hanging ear structure 50 includes two hanging ears 51, and the two hanging ears 51 are also arranged opposite to each other. When the delivery steel cable 60 is connected to the tubular cavity flow regulator, the two limiting protrusions 611 extend into the two hanging ears 51 respectively to form limiting stops, thereby realizing the connection between the delivery steel cable 60 and the tubular cavity flow regulator.

[0050] In this embodiment, the limiting protrusion 611 on the connector 61 hooks the lumen flow regulator ears 51 one by one, so that the lumen flow regulator and the delivery cable 60 can be removably and reliably combined. Through the above arrangement, when releasing the lumen flow regulator, before the limiting protrusion 611 is separated from the delivery sheath 70, the lumen flow regulator can be withdrawn and adjusted to avoid improper operation causing the lumen flow regulator to be released in a poor position or other adverse conditions, thereby causing the lumen flow regulator to fail to achieve the intended function. During the release process, medical personnel can adjust the release degree and position of the lumen flow regulator at any time, reduce intraoperative risks and the difficulty of emergency treatment, and at the same time realize the recovery of the lumen flow regulator.

[0051] The specific use process of the coronary sinus constriction device in this embodiment is as follows:

[0052] First, by hooking the lugs 51 of the lumen flow regulator on the corresponding limiting protrusions 611 on the delivery cable 60, the delivery cable 60 is withdrawn backward, and the lumen flow regulator is placed in the delivery sheath 70 under the traction of the connector 61. Move the coronary sinus constriction device to the target position. When switching from the storage state to the release state, the delivery sheath 70 is withdrawn so that one end of the lumen flow regulator extends out of the delivery sheath 70 and returns to the second expansion section 30 under the action of the shape memory property. As the delivery sheath 70 is gradually withdrawn, the lumen flow regulator gradually returns to its original state. When the limiting protrusion 611 is completely withdrawn from the delivery sheath 70, the lug 51 is autonomously detached from the limiting protrusion 611. At this time, the lumen flow regulator is completely released, detached from the delivery component and supported and fixed at the target position. Then the delivery component is withdrawn from the human body to complete the entire release process.

[0053] Furthermore, before the limiting protrusion 611 is separated from the delivery sheath 70, if the position of the instrument is not ideal or there are other situations, the delivery sheath 70 is pushed forward to adjust the lumen flow regulator.

[0054] From the above description, it can be seen that the above-mentioned embodiments of the utility model achieve the following technical effects: by setting the lumen flow regulator including a layer mesh structure, the layer mesh structure is made of elastic wire material, the layer mesh structure extends axially to form a lumen channel, the lumen channel includes a first expansion section 10, a diameter reduction section 20 and a second expansion section 30 connected in sequence, the inner diameter of the first expansion section 10 and the inner diameter of the second expansion section 30 are both larger than the inner diameter of the diameter reduction section 20, and the end of the first expansion section 10 is provided with an ear structure 50, at least a part of the delivery cable 60 of the coronary sinus narrowing device extends into the ear structure 50 and is limited by the ear structure 50, so that the lumen flow regulator and the delivery The steel cable 60 is detachably connected, so that throttling adjustment can be achieved by setting the reduced diameter section 20, so that the back pressure is increased, the compliance is strong, the use is convenient, and no balloon dilation is required, which simplifies the surgical procedure. The elastic wire has shape memory properties, so that the lumen flow regulator can automatically return to its original shape during the release process, which is convenient and quick. Furthermore, by setting a hook structure 50 on the first expansion section 10, the delivery steel cable 60 and the hook structure 50 are detachably connected, so that the lumen flow regulator can be withdrawn and adjusted before release and the lumen flow regulator can be recovered after release, thereby reducing intraoperative risks and the difficulty of emergency treatment, and greatly improving the ease of use of the coronary sinus narrowing device.

[0055] 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, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0056] It should be noted that the terms "first", "second", etc. in the specification and claims of the present 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 should be understood that the numbers used in this way can be interchanged where appropriate, so that the embodiments of the present application described herein can be implemented in an order other than those illustrated or described herein.

[0057] The above description is only the preferred embodiment of the utility model, and is not intended to limit the utility model. For those skilled in the art, the utility model can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the utility model shall be included in the protection scope of the utility model.

Claims

1. A lumen flow regulator, characterized in that: The invention comprises a layered mesh structure, wherein the layered mesh structure is made of elastic wire material, and the layered mesh structure extends axially to form a tubular passage, wherein the tubular passage comprises a first expansion section (10), a diameter reduction section (20) and a second expansion section (30) which are connected in sequence, wherein the inner diameter of the first expansion section (10) and the inner diameter of the second expansion section (30) are both larger than the inner diameter of the diameter reduction section (20), and an ear structure (50) is provided at the end of the first expansion section (10), and at least a part of a delivery cable (60) of a coronary sinus constriction device extends into the ear structure (50) and is limited by the ear structure (50), so that the tubular flow regulator is detachably connected to the delivery cable (60).

2. The lumen flow regulator according to claim 1, characterized in that: The hanging ear structure (50) comprises a plurality of hanging ears (51), and the plurality of hanging ears (51) are arranged at intervals along the circumference of the first expansion section (10).

3. The lumen flow regulator according to claim 2, characterized in that: The hanging ear (51) is a single wire structure or a multi-wire spirally wound structure made of the elastic wire material.

4. The lumen flow regulator according to claim 2, characterized in that: The hanging ear (51) comprises a first extension section, a curved section and a second extension section which are connected in sequence; the first extension section and the second extension section are respectively connected to the first expansion section (10), and the curved section is in a rounded arc shape.

5. The lumen flow regulator according to claim 1, characterized in that: The ear hook structure (50) and the layered net structure are woven together from a whole piece of the elastic wire material; or The ear hanging structure (50) is bonded to the layered mesh structure; or The hanging ear structure (50) is welded to the layer mesh structure.

6. A coronary sinus constriction device, characterized in that: The invention comprises a delivery component and a lumen flow regulator according to any one of claims 1 to 5, wherein the lumen flow regulator and the delivery component are detachably connected.

7. The coronary sinus constriction device according to claim 6, characterized in that: The conveying assembly comprises: A conveying steel cable (60), wherein the conveying steel cable (60) is provided with a connecting piece (61), and the connecting piece (61) is detachably connected to the hanging ear structure (50); A delivery sheath tube (70), wherein the lumen flow regulator is accommodated in the delivery sheath tube (70).

8. The coronary sinus constriction device according to claim 7, characterized in that: The connecting piece (61) has a limiting protrusion (611) radially protruding from the outer surface of the connecting piece (61), and the limiting protrusion (611) extends into the hanging ear structure (50) and is a limiting stopper of the hanging ear structure (50).

9. The coronary sinus constriction device according to claim 8, characterized in that: The connecting member (61) has an annular main body, the annular main body is sleeved on the conveying steel cable (60), and the limiting protrusion (611) protrudes radially from the outer surface of the annular main body.

10. The coronary sinus constriction device according to claim 8, characterized in that: There are a plurality of the limiting protrusions (611), and the plurality of limiting protrusions (611) are arranged in a one-to-one correspondence with the plurality of hanging ears (51) of the hanging ear structure (50).

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