Vascular flow limiter

Abstract

This invention relates to a vascular flow restrictor, comprising: a tubular body, a first fixing member, and at least one second fixing member; the tubular body includes an inflow end and an outflow end; the inflow end is provided with a first opening, and the outflow end is provided with a second opening, the continuous cavity defined between the first opening and the second opening forming a hollow cavity of the tubular body; the outflow end of the tubular body is constricted into at least two connecting bundles, the connecting bundles being fixed by the first fixing member or the second fixing member; the first fixing member has a connecting portion for connecting with an external connecting member; the second fixing member has a communicating hole for the external connecting member to pass through. The vascular flow restrictor of this invention, by constricting the outflow end into at least two connecting bundles, creates a tapered structure in the hollow cavity, reducing the blood flow rate, and allowing the connection of at least two connecting bundles to be achieved with a single connecting member, thus reducing the required inner diameter of the delivery sheath.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a vascular flow restrictor. Background Technology

[0002] The cardiovascular system is a closed transport system composed of the heart, arteries, capillaries, and veins. The continuous beating of the heart propels blood through this system, providing essential substances such as nutrients and oxygen to the body's cells and removing metabolic waste products like carbon dioxide. Simultaneously, many hormones and other signaling substances are transported via the blood to their target organs, coordinating the body's overall function. Therefore, maintaining a healthy circulatory system is crucial for the body's survival, with maintaining blood pressure at a normal level being paramount. Thus, the balance between blood supply and demand plays a vital role in the normal functioning of organs.

[0003] For example, when factors such as low blood pressure, reduced aortic blood supply, or coronary artery blockage cause an imbalance between myocardial blood supply and demand, and the body is unable to maintain a relatively constant blood supply and demand through normal self-regulation, the heart may malfunction. Similarly, congenital cardiovascular abnormalities, septal defects, and arterial vascular diseases leading to increased arterial blood flow and pulmonary hypertension can severely affect the normal functioning of organs such as the heart and lungs. One current treatment approach involves adjusting blood flow in local blood vessels to reconstruct blood flow distribution and restore a balance between blood supply and demand.

[0004] In addition, certain diseases can be treated by adjusting blood flow perfusion, such as reducing the digestive efficiency of the intestines by decreasing the arterial blood supply to the intestines, thus helping severely obese patients who cannot lose weight through individual weight loss.

[0005] Currently, adjusting blood flow by surgically ligating or narrowing target blood vessels is quite harmful to the human body, has a long recovery time, and may cause various complications, endangering the patient's health. Therefore, it is necessary to provide a blood flow adjustment device for interventional treatment. Summary of the Invention

[0006] The present invention aims to provide a vascular flow restrictor for interventional therapy, which can adjust the blood flow in the blood vessels and cause minimal trauma to the human body.

[0007] The vascular flow restrictor provided by the present invention includes a tubular body, a first fixing member, and at least one second fixing member;

[0008] The tubular body has an outlet end and an inlet end; the outlet end is provided with a first opening, and the inlet end is provided with a second opening, the continuous cavity between the first opening and the second opening forms the hollow cavity of the tubular body; the inlet end of the tubular body is constricted into at least two connecting bundles, and the connecting bundles are fixed by the first fixing member or the second fixing member.

[0009] The first fastener is used for detachable connection with an external connector;

[0010] The second fastener has a connecting hole for the distal end of the external connector to pass through.

[0011] In one embodiment, the first fastener is closer to the inflow end of the vascular restrictor than the second fastener.

[0012] In one embodiment, the tubular body includes an inner layer and an outer layer.

[0013] In one embodiment, the inner layer is folded outward to form the outer layer, and the inflow end is formed at the fold of the inner layer. The end of the outer layer away from the inflow end is constricted by the first or second fastener to form the outflow end.

[0014] In one embodiment, the inner layer has a narrowing portion located between the first opening and the second opening, the flow area defined by the narrowing portion being smaller than the flow area defined by the second opening.

[0015] In one embodiment, the vascular flow restrictor further includes a narrowing ring having a flow hole, the narrowing ring being sleeved outside the narrowing portion of the inner layer; and the flow hole connecting the first opening and the second opening.

[0016] In one embodiment, the end of the inner layer away from the first opening is converged together with the outer layer to form the outflow end; or the end of the inner layer away from the first opening is converged to the narrowing ring.

[0017] In one embodiment, the vascular restrictor has a spiral structure; the inner layer extends spirally from the inflow end to the narrowing portion to form the spiral structure.

[0018] In one embodiment, the vascular flow restrictor has a spiral structure; the spiral structure has a first end, a second end, and a spiral channel disposed between the first end and the second end; the first end is connected to the inflow end, the second end is connected to the outflow end, and the spiral channel communicates the first opening and the second opening.

[0019] In one embodiment, the maximum outer diameter of the spiral structure is equal to or greater than the maximum diameter of the outer layer in its natural state.

[0020] The outflow end of the vascular flow restrictor of the present invention is constricted into at least two connecting bundles, such that the diameter of the second opening at the outflow end is smaller than the diameter of the first opening at the inflow end. Consequently, the hollow cavity between the first and second openings has a tapered structure, which can narrow the local inner diameter of the blood vessel, achieving the effect of blood flow regulation. The at least two connecting bundles are respectively connected to the first and second fixing members. When delivering the vascular flow restrictor, the external connector can first pass through the second fixing member and then connect to the first fixing member. That is, at least two connecting bundles can be connected using a single external connector, reducing the required inner diameter of the delivery sheath and enabling the delivery system carrying the vascular flow restrictor to reach the target location through blood vessels with smaller diameters. Attached Figure Description

[0021] Figure 1 This is a front view of the vascular flow restrictor of Example 1.

[0022] Figure 2 This is a top view of the vascular flow restrictor of Example 1.

[0023] Figure 3 This is a schematic diagram of the assembly of the vascular flow restrictor and external connector in Example 1.

[0024] Figure 4 This is a schematic diagram of the vascular flow restrictor of Example 1 (the outer layer is transparent).

[0025] Figure 5 This is a schematic diagram of the vascular flow restrictor in Example 2 (the outer layer is transparent to hide the narrowing ring).

[0026] Figure 6 This is a front view of the vascular flow restrictor of Example 2 (the outer layer is transparent).

[0027] Figure 7 This is a front view of a vascular flow restrictor in another embodiment (the outer layer is transparent).

[0028] Figure 8 This is a front view of the vascular flow restrictor of Example 3 (the outer layer is transparent).

[0029] Figure 9 This is a front view of a vascular flow restrictor in another embodiment (the outer layer is partially transparent). Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0031] Unless otherwise defined, 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 invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0032] Example 1

[0033] like Figure 1 This embodiment provides a vascular flow restrictor 1, which includes: a tubular body 11, a first fixing member 12, and at least one second fixing member 13; the tubular body 11 includes an inflow end 111 and an outflow end 112; the inflow end 111 is provided with a first opening 113, and the outflow end 112 is provided with a second opening 114, such as... Figure 2 As shown, the continuous cavity defined between the first opening 113 and the second opening 114 forms the hollow cavity 115 of the tubular body 11; the outflow end 112 of the tubular body 11 is converged into at least two connecting bundles, which are fixed by the first fixing member 12 or the second fixing member 13.

[0034] The first fastener 12 is detachably connected to the external connector 2; the second fastener 13 has a through hole 131 for the distal end of the external connector 2 to pass through.

[0035] like Figure 1 As shown, for ease of understanding, Figure 1 The two connecting bundles are a first connecting bundle 112a and a second connecting bundle 112b, wherein the first connecting bundle 112a is fixedly connected to the first fixing member 12, and the second connecting bundle 112b is fixedly connected to the second fixing member 13. Figure 3 As shown, the external connector 2 (such as a steel cable, a guide wire, etc.) first passes through the connecting hole 131 of the second fixing member 13 and then connects to the first fixing member 12. The external connector 2 and the first fixing member 12 can be connected by a detachable connection method such as a threaded connection or a hook connection. This embodiment does not impose any restrictions.

[0036] The outflow end 112 of the vascular flow restrictor 1 of the present invention is bundled into at least two connecting bundles, such that the diameter of the second opening 114 at the outflow end 112 is smaller than the diameter of the first opening 113 at the inflow end 111. Furthermore, the hollow cavity 115 between the first opening 113 and the second opening 114 has a tapered structure, which can narrow the local inner diameter of the blood vessel, achieving the effect of regulating blood flow. When the vascular flow restrictor 1 of the present invention is implanted into the venous sinus, it can restrict the blood flow returning to the right atrium through the venous sinus, increasing the pressure of the blood flowing into the venous sinus. The increased pressure facilitates blood entering the capillaries of the myocardium, ensuring sufficient blood perfusion to the myocardium and restoring normal cardiovascular supply and demand and normal function. When the vascular flow restrictor 1 of the present invention is implanted into the pulmonary artery, it can effectively reduce the blood flow from the right atrium to the lungs, increase the right ventricular pressure, reduce left-to-right shunt, and alleviate the load on the left and right hearts, thereby controlling congestive heart failure. The vascular flow restrictor 1 of the present invention can also be used to restrict splenic artery blood flow to treat hypersplenism, and to restrict intestinal artery blood flow to help severely obese patients lose weight. The applicable conditions listed above are only used to illustrate the structure and technical effects of the vascular flow restrictor 1 of the present invention, and are not intended to limit the scope of use of the vascular flow restrictor 1 of the present invention. The vascular flow restrictor 1 of the present invention can be used in any lumen where flow regulation is required.

[0037] Understandably, since the tapered hollow cavity 115 of the vascular flow restrictor 1 is formed by dividing the outflow end 112 of the tubular body 11 into bundles, rather than by the tubular body 11 contracting inward as a whole, as... Figure 1 and Figure 2 As shown, the outer surface 1121 of the connecting bundle is slightly inclined inward or remains parallel to the central axis L of the vascular flow restrictor 1. This means that when the vascular flow restrictor 1 is implanted into a blood vessel, the connecting bundle can still contact the blood vessel wall, ensuring the anchoring performance of the vascular flow restrictor.

[0038] The at least two connecting bundles are respectively connected to the first fixing member 12 and the second fixing member 13. When delivering the vascular flow restrictor 1, the external connecting member 2 can first pass through the second fixing member 13 and then connect to the first fixing member 12. That is, at least two connecting bundles can be connected using only one external connecting member 2, reducing the required inner diameter of the delivery sheath and allowing the delivery system carrying the vascular flow restrictor to reach the target location through a smaller diameter blood vessel. This is especially important for pulmonary hypertension caused by congenital heart disease, where most patients are infants and young children, requiring a small-diameter delivery system for interventional procedures. Furthermore, as... Figure 3 As shown, after the connecting bundle is connected to the external connector 2, the outflow end 112 of the vascular flow restrictor 1 is generally formed into a tapered shape, so the vascular flow restrictor can be more easily bundled into the delivery sheath.

[0039] It should be noted that this embodiment and the accompanying drawings only provide an example of the vascular flow restrictor 1 including one second fixing member 13, but this does not represent a limitation on the number of second fixing members 13 of the vascular flow restrictor 1. In other embodiments, the vascular flow restrictor 1 may include two or more second fixing members 13. Accordingly, the number of the connecting bundles is the same as the total number of the first fixing members 12 and the second fixing members 13. The external connecting member 2 passes through all the second fixing members 13 in sequence and then connects to the first fixing member 12.

[0040] The tubular body is formed by weaving nickel-titanium wire or other shape-memory metal wire. The first fixing member 12 and the second fixing member 13 are made of a biocompatible metal material such as stainless steel. In this embodiment, the connecting bundle 112b of the tubular body 11 is directly welded or bonded to the inner wall of the second fixing member 13, so that the second fixing member 13 still has the communicating hole 131 after connecting the connecting bundle 112b. In other embodiments, the second fixing member 13 may have two holes, one for connecting the connecting bundle 112b and the other for forming the communicating hole 131.

[0041] The first fixing member 12 is closer to the inflow end 111 of the blood vessel restrictor 1 than the second fixing member 13.

[0042] During the connection process between the vascular flow restrictor 1 and the external connector 2, the external connector 2 is sequentially connected to the second fixing member 13 and the first fixing member 12 along the direction from the outflow end 112 to the inflow end 111 of the vascular flow restrictor 1. Therefore, the second fixing member 13, which needs to be connected to the external connector 2 first, is farther away from the inflow end 111 than the first connector, making it easier for the operator to assemble the vascular flow restrictor 1 and the external connector 2.

[0043] like Figure 4 As shown (for ease of understanding, Figure 4 The outer layer 117 is transparent, the dashed line represents the inner layer 116, and the solid arrow indicates the direction of blood flow. The tubular body 11 includes an inner layer 116 and an outer layer 117. The double-layer mesh structure not only enhances the supporting strength of the vascular flow restrictor 1, but also increases the wall density of the tubular body 11, reduces the size of the gaps, and increases the resistance for blood flow to directly cross the wall of the tubular body 11. This allows most of the blood to flow through the hollow cavity 115 of the tubular body 11, thereby reducing the blood flow rate by means of the gradually narrowing hollow cavity 115.

[0044] In this embodiment, the inner layer 116 is folded outward to form the outer layer 117. The folded portion of the inner layer 116 forms the inflow end 111, and the end of the outer layer 117 away from the inflow end 111 forms the outflow end 112. Specifically, the vascular flow restrictor 1 is made of a complete braided mesh tube. One section of the braided mesh tube is folded outward to form the outer layer 117 of the vascular flow restrictor 1, and the other section of the braided mesh tube forms the inner layer 116 of the vascular flow restrictor 1. The folded portion forms the inflow end 111 of the vascular flow restrictor 1. The folded inflow end 111 is smoother than the end of a single-layer mesh tube, which can prevent the vascular flow restrictor 1 from scratching the blood vessel wall. The two ends of the braided mesh tube overlap and are away from the inflow end 111. In this embodiment, both ends of the braided mesh tube are gathered in the first fixing member 12 or the second fixing member 13, thereby forming the outflow end 112 of the vascular flow restrictor 1. This makes the structure of the vascular flow restrictor 1 more stable. The inner layer 116 moves within the outer layer 117, which also prevents the inner layer 116 from moving away from the outflow end 112 or even gradually folding outward and deforming under the scouring of the reverse blood flow after the vascular flow restrictor 1 is implanted in the human body.

[0045] In other embodiments, the connection between the inner layer 116 and the outer layer 117 at the inflow end 113 can also be achieved by suture connection, adhesive connection, or welding connection. In other embodiments, the tubular body 11 may have only one layer. During weaving, each metal wire spirally winds upward around the cylindrical structure to a predetermined height and then folds back and winds downward. The folded-back section serves as the inflow end 111 of the vascular flow restrictor 1. All broken ends of the metal wires are gathered in the first fixing member 12 or the second fixing member 13 to prevent the broken ends of the metal wires from piercing the blood vessel wall.

[0046] Example 2

[0047] The main difference between the vascular flow restrictor 2 in this embodiment and the vascular flow restrictor 1 in embodiment 1 is that, Figures 5 to 7 As shown (for ease of understanding, Figures 5 to 7The outer layer 217 or outer layer 217a is transparent, the dashed part represents the inner layer 216 or inner layer 216a, and the solid arrow indicates the blood flow direction. The inner layer 216 has a narrowing portion 2161, which is located between the first opening 213 and the second opening 214. The flow area defined by the narrowing portion 2161 is smaller than the flow area defined by the second opening 214. The plane perpendicular to the central axis of the vascular flow restrictor 2 is the projection plane. The flow area defined by the narrowing portion 2161 is the area of ​​the inner cavity of the inner layer 216 at the narrowing portion 2161 on the projection plane, and the flow area of ​​the second opening 214 is the area of ​​the second opening 214 on the projection plane. The narrowing portion 2161 further narrows the hollow cavity of the vascular flow restrictor 2. When the vascular flow restrictor 2 is implanted into the coronary sinus, on the one hand, it can further increase the blood pressure at the inflow end of the vascular flow restrictor 2, allowing blood to be better perfused into the myocardium; on the other hand, as the blood pressure at the inflow end of the vascular flow restrictor 2 further increases, the blood at the outflow end of the vascular flow restrictor 2 is less likely to flow backward through the second opening 214 to the first opening 213, and the inner layer 216 becomes denser after narrowing, which has a blocking effect on the blood flowing backward through the second opening 214 to the first opening 213.

[0048] The narrowing portion 2161 is formed by a heat setting process or by a narrowing ring 24, such as... Figure 6 As shown, the narrowing ring 24 has a flow hole (not shown in the figure), and the narrowing ring 24 is sleeved on the outside of the narrowed portion 2161 of the inner layer 216; and the flow hole connects the first opening 213 and the second opening 214. Adding the narrowing ring 24 can prevent the narrowed portion 2161 from deforming or spreading out. The narrowing ring 24 can be a ring-shaped component made of polymer material or metal material, or it can be a ring structure formed by wrapping wire around the narrowed portion one or more times.

[0049] In this embodiment, the end of the inner layer 216 away from the first opening 213 is tapered together with the outer layer 217 to form the outflow end, that is, both ends of the inner layer 216 are connected to the outer layer 217, and the narrowing portion 2161 is provided in the middle.

[0050] In other embodiments, such as Figure 7 As shown, the end of the inner layer 216a away from the first opening 213a is constricted by the narrowing ring 24a, and only the outer layer 217a is connected to the first fixing member and the second fixing member. The connecting hole on the narrowing ring 24a connects the first opening 213a and the second opening 214a.

[0051] Example 3

[0052] The main difference between the vascular flow restrictor 3 in this embodiment and the vascular flow restrictor 2 in embodiment 2 is that, as Figure 8 and Figure 9 As shown (for ease of understanding, Figure 8 and Figure 9 The outer layer 317 or outer layer 317a is transparent, the dashed part represents the inner layer 316 or inner layer 316a, and the solid arrow indicates the direction of blood flow. The vascular flow restrictor 3 has a spiral structure 3162; the inner layer 316 extends spirally from the inflow end 313 to the narrowing part 3161 to form the spiral structure 3162. The spiral structure 3162 makes it more difficult for retrograde blood to flow from the second opening 314 back to the first opening 313, while normal antegrade blood can flow smoothly through the spiral structure 3162 through the vascular flow restrictor 3, preventing blood reflux. This is especially effective when the vascular flow restrictor 3 is used for the coronary sinus, preventing blood from the right atrium from flowing back into the coronary vein. The antegrade blood refers to blood flowing from the first opening 313 to the second opening 314 of the vascular flow restrictor 3. On the other hand, the mesh structure of the inner layer 316 after spiraling is more dense, which can prevent blood from passing through the inner layer 316 and causing the flow restriction function of the vascular flow restrictor 3 to fail.

[0053] Furthermore, the maximum outer diameter of the spiral structure 3162 is equal to or greater than the maximum diameter of the outer layer 317 in its natural state. Here, the outer layer 317 in its natural state refers to the state where it is not subject to external force. When the vascular flow restrictor 3 is released into the blood vessel, the spiral structure 3162 returns to its original shape, pressing the outer layer 317 outwards, causing it to tightly abut against the blood vessel wall, thus improving the anchoring performance of the vascular flow restrictor 3. The spiral structure 3162 can be formed by pre-shaping one section of the braided mesh tube using a heat-setting process, then flipping the other section of the braided mesh tube outwards to form the outer layer 317. Alternatively, an inner layer 316 with the spiral structure 3162 can be fabricated first, and then the outer layer 317 can be connected to the inner layer 316 using sutures, welding, or adhesive bonding.

[0054] In other embodiments, such as Figure 9As shown, the spiral structure 35a is independent of the inner layer 316a and the outer layer 317a. The spiral structure 35a has a first end 351a, a second end 352a, and a spiral channel (not shown in the figure) disposed between the first end 351a and the second end 352a. The first end 351a is connected to the inflow end 311a, and the second end 352a is connected to the outflow end 312a. The spiral channel connects the first opening 351a and the second opening 352a. In this embodiment, the spiral structure 35a is made of shape memory metal braided mesh, which, when added to the vascular flow restrictor with a double-layer structure, can further increase the support strength of the vascular flow restrictor, that is, improve the anchoring ability of the vascular flow restrictor in the blood vessel.

[0055] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0056] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A vascular flow restrictor, characterized in that, include: A tubular body, a first fastener, and at least one second fastener; The tubular body includes an inflow end and an outflow end; the inflow end is provided with a first opening, the outflow end is provided with a second opening, and the continuous cavity defined between the first opening and the second opening forms the hollow cavity of the tubular body. The outflow end of the tubular body is constricted into at least two connecting bundles, which are respectively connected to the first fixing member and the second fixing member, so that the hollow cavity located between the first opening and the second opening forms a tapered structure; The first fastener is used for detachable connection with an external connector; The second fastener has a communicating hole for the distal end of the external connector to pass through; The number of the connecting bundles is the same as the total number of the first and second fixing members, so that when the vascular flow restrictor is delivered, the external connector can pass through all the second fixing members first, and then connect to the first fixing member.

2. The vascular flow restrictor according to claim 1, characterized in that, The first fixing member is closer to the inflow end of the vascular flow restrictor than the second fixing member.

3. The vascular flow restrictor according to claim 1, characterized in that, The tubular body comprises an inner layer and an outer layer.

4. The vascular flow restrictor according to claim 3, characterized in that, The inner layer is folded outward to form the outer layer, and the inflow end is formed at the fold of the inner layer. The end of the outer layer away from the inflow end is constricted by the first or second fixing member to form the outflow end.

5. The vascular flow restrictor according to claim 3, characterized in that, The inner layer has a narrowed portion located between the first opening and the second opening, and the flow area defined by the narrowed portion is smaller than the flow area defined by the second opening.

6. The vascular flow restrictor according to claim 5, characterized in that, The vascular flow restrictor also includes a narrowing ring, which has a flow hole and is sleeved on the narrowing portion of the inner layer; and the flow hole connects the first opening and the second opening.

7. The vascular flow restrictor according to claim 6, characterized in that, The end of the inner layer away from the first opening is converged together with the outer layer to form the outflow end; or the end of the inner layer away from the first opening is converged to the narrowing ring.

8. The vascular flow restrictor according to claim 5, characterized in that, The vascular flow restrictor has a spiral structure; the inner layer extends spirally from the inflow end to the narrowing portion to form the spiral structure.

9. The vascular flow restrictor according to claim 3, characterized in that, The vascular flow restrictor has a spiral structure; the spiral structure has a first end, a second end, and a spiral channel disposed between the first end and the second end; the first end is connected to the inflow end, the second end is connected to the outflow end, and the spiral channel communicates with the first opening and the second opening.

10. The vascular flow restrictor according to any one of claims 8 or 9, characterized in that, The maximum outer diameter of the spiral structure is equal to or greater than the maximum diameter of the outer layer in its natural state.

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