A constriction device for a valve annulus constrictor

Abstract

This invention belongs to the field of interventional medical device technology, specifically relating to a contraction device for a valve annulus retractor. The invention provides a contraction device for a valve annulus retractor, comprising: an implantable annulus body: the implantable annulus body is a hollow, flexible cylindrical structure; a contraction spring: the outer side of the annular structure of the contraction spring is fixedly connected to the inner wall of the hollow structure of the implantable annulus body; and a contraction pull cord: the distal end of the contraction pull cord is fixedly connected to the distal end of the contraction spring, and the contraction pull cord passes through the contraction spring. It is used for the contraction of heart valves during interventional surgery; by setting the spring structure, the contraction device is simplified and its weight is reduced; greatly reducing the burden on the patient's heartbeat.

Description

Technical Field

[0001] This invention belongs to the field of interventional medical device technology, specifically relating to a contraction device for a valve annulus constrictor. Background Technology

[0002] Minimally invasive interventional medical technology is a highly efficient diagnostic and treatment method that has gradually emerged in recent years. It boasts significant advantages such as minimal trauma, ease of operation, precise intervention site selection, and fewer complications, and has become one of the most important diagnostic and treatment methods for cardiovascular and oncological diseases. In interventional medical procedures, skilled physicians typically need to manually and mechanically manipulate one or more slender, flexible catheters of different shapes and functions to address the complex and ever-changing internal cavities of the patient's cardiovascular system and other organs. This allows them to deliver catheters, guidewires, stents, and other instruments to the intended lesion site for minimally invasive treatment.

[0003] The incidence of mitral valve disease remains high among adult heart valve diseases. Mitral regurgitation (MR) is particularly serious. Normally, the mitral valve in the human heart acts as a hemostatic valve, preventing oxygenated blood from the lungs from flowing back into the left atrium. When the mitral valve malfunctions, such as improper closure or misalignment, MR occurs, significantly reducing the heart's pumping efficiency and even leading to heart failure. Mitral regurgitation is divided into functional and degenerative types. Functional mitral regurgitation (FMR) is characterized by mitral annular dilation, inadequate leaflet junction, and mitral valve leaflet tethering, caused by left ventricular dysfunction and remodeling. In the context of FMR, the poor outcomes and unclear benefits of surgical mitral valve repair have encouraged the search for alternative, innovative catheter and minimally invasive solutions, such as percutaneous edge-to-edge repair, indirect annulus repair, direct annulus repair, and transcatheter mitral valve replacement. Mitral annulus repair (MVA), or valve replacement, is the most common surgical treatment for FMR. The Cardioband system (Edwards Lifescience, Irvine, USA) is a percutaneously adjustable surgical direct annulation device. Because it is implanted into the beating heart via a transvenous access through the septum, it can reduce the size of the mitral septum in real time and improve leaflet engagement on the beating heart. To date, more than 400 FMR patients have received Cardioband implantation. The Cardioband Delivery System (CDS) is a seamless suture band for annulation surgery that strictly replicates the surgical annulation procedure. It consists of three parts: (1) an implant delivery system for continuous navigation across the annulus; (2) an anchoring actuator for anchor placement and one-to-one torque transmission; and (3) an internal sizing tool and adjustment mechanism that provides uniform, progressive tightening. Cardioband uses a delivery sheath to deliver multiple anchoring screws and precisely screw them into specific positions to fix the polymer annulus around the valve. After all screws are screwed in, the annulus is tightened by pulling the suture to achieve valve shrinkage.

[0004] However, the current ring-contraction devices are very complex in structure, and the weight of the device that needs to be left in the body is relatively large, which is not conducive to reducing the burden on the patient's heart. At the same time, the current pull-wire contraction method lacks a simple and effective self-locking structure. As the heart continues to beat, the contraction effect may gradually weaken or even disappear during the continuous vibration, resulting in the inability to maintain the treatment effect for a long time. Summary of the Invention

[0005] To address the above problems, the present invention provides a constriction device for a valve annulus constrictor, comprising:

[0006] Implant ring: The implant ring is a hollow, flexible cylindrical structure;

[0007] Contraction spring: The outer side of the annular structure of the contraction spring is fixedly connected to the inner wall of the hollow structure of the implanted ring;

[0008] Retractable pull cord: The distal end of the retractable pull cord is fixedly connected to the distal end of the retractable spring, and the retractable pull cord passes through the retractable spring.

[0009] As a preferred technical solution, the retraction spring is provided with a limiting hole, and the retraction rope passes through the limiting hole and extends from the distal end to the proximal end of the retraction spring.

[0010] As a preferred technical solution, the retraction spring is provided with multiple limiting holes on the same cross section, and each of the multiple limiting holes on the same cross section is provided with an independent retraction rope.

[0011] As a preferred technical solution, each of the retractable pull ropes is fixedly provided with several blocks. The blocks are rotating bodies with a uniformly varying cross-sectional area. From the near end to the far end, the cross-sectional area of ​​the blocks increases uniformly. The maximum cross-sectional area of ​​the blocks is smaller than the area of ​​the limiting hole.

[0012] As a preferred technical solution, the retractable pull cord is provided with an adjusting buckle, which has a hollow structure in the middle. The retractable pull cord passes through the hollow structure in the middle of the adjusting buckle and is movably connected to the adjusting buckle. The diameter of the hollow structure in the middle of the adjusting buckle is variable, and the maximum cross-sectional diameter of the stop block is located between the maximum and minimum diameters of the hollow structure in the middle of the adjusting buckle.

[0013] As a preferred technical solution, the adjusting buckle includes a frame, a compression spring, and a slider; the slider is a split design, comprising several independent parts, the outer ring of the slider is fixedly connected to the frame by the compression spring, and the inner side of the slider is provided with a gap hole.

[0014] As a preferred technical solution, it also includes a plurality of push rods, wherein the push rods are hollow rods, the push rods are slidably disposed on the retractable pull rope, the hollow diameter of the push rods is larger than the maximum cross-sectional diameter of the stop block, and the hollow diameter of the push rods is smaller than the outer diameter of the adjusting buckle.

[0015] As a preferred technical solution, it also includes a compression rod, the diameter of which is smaller than the coil diameter of the contraction spring, for using to abut against the contraction spring.

[0016] As a preferred technical solution, the retractable pull rope is provided with an electric de-energizing point, which is located near the end of the stop block.

[0017] As a preferred technical solution, the implanted ring is provided with anchor pins.

[0018] Beneficial effects:

[0019] (1) The present invention provides a valve annulus contraction device for contraction of heart valves in interventional surgery; by setting a spring structure, the contraction device is simplified and the weight of the device is reduced; the burden on the patient's heartbeat is greatly reduced.

[0020] (2) Through the combination of limiting hole, stop block and adjustment buckle, a simple and reliable self-locking mechanism is provided, which can achieve self-locking at any time when the contraction spring is compressed to any position, thereby allowing the device to be used in the treatment process of different patients. It can provide feasible treatment methods for heart valves of different sizes, shapes and contraction requirements, thus expanding the scope of application of the device.

[0021] (3) By setting an electrolytic release point on the contraction cord, the contraction cord can be disconnected outside the body, allowing the contraction spring to drive the heart valve to contract by pulling the contraction cord outside the body during operation. At the same time, the contraction cord can be disconnected outside the body after the operation is completed, leaving the part that performs the contraction and locking functions inside the body, and recycling the part that does not play a key role, thus reducing the mass of the parts left inside the body. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the structure of a valve annulus contraction device provided by the present invention;

[0024] Figure 2 This is a schematic diagram of the adjusting buckle;

[0025] Figure 3 yes Figure 1 Enlarged view of point A in the middle;

[0026] 1-Implanted ring, 2-Retraction spring, 21-Limiting hole, 3-Retraction pull rope, 31-Stop block, 32-Electrical release point, 4-Adjusting buckle, 41-Frame, 42-Compression spring, 43-Slider, 44-Gap hole, 5-Propulsion rod, 6-Compression rod, 7-Anchor nail. Detailed Implementation

[0027] The invention can be further understood by referring to the following detailed description of preferred embodiments and included examples.

[0028] When describing embodiments of this application, the terms "preferred," "more preferably," "more preferably," etc., refer to embodiments of the invention that provide certain beneficial effects in certain circumstances. However, other embodiments may also be preferred in the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are unavailable, nor is it intended to exclude other embodiments from the scope of this invention.

[0029] In this document, relational terms such as first, second, etc., are used merely to distinguish one entity from another, without necessarily requiring or implying any such actual relationship or order between these entities. Moreover, the terms "comprising," "including," or any other such arguments cover non-exclusive inclusion, such that a component, apparatus, or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such component, apparatus, or device.

[0030] When a component, element, or layer is referred to as being "located in," "bonded to," "connected to," or "attached to" another component or layer, it may be directly located in, bonded to, connected to, or attached to that other component, element, or layer, or there may be intermediate elements or intermediate layers. Conversely, when an element is referred to as being "directly located in," "directly bonded to," "directly connected to," or "directly attached to" another component or layer, there may be no intermediate elements or intermediate layers. Other terms used to describe relationships between elements should be interpreted in a similar manner (e.g., "between" and "directly between," "adjacent" and "directly adjacent," etc.).

[0031] In this article, "proximal end" refers to the end of the medical device that is closer to the doctor when the doctor is using it; "distal end" refers to the end of the medical device that is farther away from the doctor when the doctor is using it. This terminology conforms to the conventional practice in the medical device industry.

[0032] according to Figures 1-3 The valve annulus constrictor shown includes a constriction device comprising:

[0033] Implantable ring 1: The implantable ring 1 is a hollow, flexible cylindrical structure;

[0034] Contraction spring 2: The outer side of the annular structure of the contraction spring 2 is fixedly connected to the inner wall of the hollow structure of the implanted ring 1;

[0035] Retractable pull cord 3: The distal end of the retractable pull cord 3 is fixedly connected to the distal end of the retractable spring 2, and the retractable pull cord 3 passes through the retractable spring 2.

[0036] Preferably, the implanted ring 1 is a polymer ring.

[0037] The retraction spring 2 is provided with a limiting hole 21, and the retraction pull rope 3 passes through the limiting hole 21 and extends from the distal end to the proximal end of the retraction spring 2.

[0038] Specifically, the limiting hole 21 penetrates all cross sections of the retraction spring 2, and the retraction cable passes through the limiting hole 21 from the furthest fixed point and extends towards the proximal end.

[0039] The retraction spring 2 has multiple limiting holes 21 on the same cross section, and each of the multiple limiting holes 21 on the same cross section has an independent retraction pull rope 3.

[0040] Each of the retractable pull ropes 3 is fixedly provided with a number of stops 31. The stops 31 are rotating bodies with a uniformly varying cross-sectional area. From the near end to the far end, the cross-sectional area of ​​the stops 31 increases uniformly. The maximum cross-sectional area of ​​the stops 31 is smaller than the area of ​​the limiting hole 21.

[0041] The stop 31 can freely pass through the limiting hole 21.

[0042] The retractable pull rope 3 is provided with an adjusting buckle 4, which is a hollow structure in the middle. The retractable pull rope 3 passes through the hollow structure in the middle of the adjusting buckle 4 and is movably connected to the adjusting buckle 4. The diameter of the hollow structure in the middle of the adjusting buckle 4 is variable, and the maximum cross-sectional diameter of the stop block 31 is located between the maximum and minimum diameters of the hollow structure in the middle of the adjusting buckle 4.

[0043] Specifically, the stop 31 can pass through the adjusting buckle 4 in the direction from the distal end to the proximal end, while the stop 31 cannot pass through the adjusting buckle 4 in the direction from the proximal end to the distal end, and the adjusting buckle 4 cannot pass through the limiting hole 21, thereby achieving the locking of the contraction spring 2 in the compressed state.

[0044] The adjusting buckle 4 includes a frame 41, a compression spring 42, and a slider 43. The slider 43 is a split design, consisting of several independent parts. The outer ring of the slider 43 is fixedly connected to the frame 41 by the compression spring 42, and a gap hole 44 is provided on the inner side of the slider 43.

[0045] Preferably, the slider 43 is configured as several independent sector-shaped structures;

[0046] When the independent structures in the slider 43 move closer to each other and come into contact with each other under the pressure of the compression spring 42, the gap hole 44 is in the minimum diameter state; when the gap hole 44 is in the minimum diameter state, the stop block 31 is prevented from passing through the adjusting buckle 4 in the direction from the proximal end to the distal end.

[0047] When the stop 31 passes through the adjusting buckle 4 in the direction from the distal end to the proximal end, the independent structures in the slider 43 move in the circumferential direction and separate from each other, thereby allowing the stop 31 to pass through the adjusting buckle 4 in the direction from the distal end to the proximal end.

[0048] It also includes several push rods 5, each push rod 5 being a hollow rod body. The push rod 5 is slidably mounted on the retractable pull rope 3. The hollow diameter of the push rod 5 is larger than the maximum cross-sectional diameter of the stop block 31, and the hollow diameter of the push rod 5 is smaller than the outer diameter of the adjusting buckle 4.

[0049] The push rod 5 is used to push the adjusting buckle 4 and provides a way to prevent the adjusting buckle 4 from moving when the stop block 31 passes through it.

[0050] It also includes a compression rod 6, the diameter of which is smaller than the coil diameter of the retraction spring 2, used to hold the retraction spring 2 in place. This prevents the retraction spring 2 from unfolding when the retraction rope 3 is pulled.

[0051] The retractable pull cord 3 is provided with an electro-disengagement point 32, which is located near the stop block 31. When the retractable pull cord 3 is energized from outside the body, the electro-disengagement point 32 disconnects, facilitating the retrieval of non-critical components, reducing the number of components remaining in the body, and alleviating the burden on the human body.

[0052] An anchor 7 is provided in the implanted ring 1; the anchor 7 is used to fix the implanted ring 1 and human tissue, especially the heart valve.

[0053] Working principle:

[0054] This invention relates to a retraction device for implanting a ring, comprising a braided implantable ring, a compressible retraction spring fixed to the ring, a retraction cord passing through the retraction spring, an anchor, an adjusting buckle, a compression rod, and a push rod. The retraction cord comprises multiple cords, evenly distributed along the circumference of the spring. The distal end of the retraction spring is fixed to the distal end of the retraction cord, and the proximal end is attached with multiple conical stops, the diameter of the conical base of the stops being slightly smaller than the diameter of the through hole in the spring. An electrolytic release point is provided at the nearest stop of the retraction cord, used to melt and break the retraction cord after external energization, allowing the remaining proximal portion to be pulled out of the body after surgery. The stops, in conjunction with the retraction cord, push rod, compression rod, and adjusting buckle, achieve the purpose of compressing the spring and retracting the implantable ring. The adjusting buckle consists of a frame, a slider, and a compression spring. When the adjusting buckle is inserted from the proximal end of the contraction cord and passes through the conical stop, the compression spring is compressed, the gap in the middle of the adjusting buckle widens, and the slider slides outward from the frame along the inclined surface of the stop until it passes through the stop. Then, the compression spring returns to its original length, the gap returns to its minimum, and the adjusting buckle is assembled to the distal end of the stop. The entire delivery process is as follows: With the assistance of the delivery catheter, the implanted ring reaches the designated location on the heart valve and is applied to the annular fibrous tissue. Multiple spiral pins are evenly screwed into the fibrous tissue using the anchoring delivery system. After all the anchors are in place, the proximal end of the contraction cord is pulled, and the compression rod is used to compress the contraction spring along the inner lumen of the catheter. As the length of the contraction spring shortens, multiple stops are exposed. Then, the adjusting buckle and the push rod are advanced into the body along the contraction cord, passing through the exposed stops one by one, until the annulus shrinks to the appropriate length. Finally, the contraction cord is energized, and the wire melts at the electrolytic decompression point, separating the traction wire and leaving the annular ring in the body.

Claims

1. A contraction device for a valve annulus constrictor, characterized in that, The utility model relates to a kind of implant ring body (1) and the structure of the implant ring body (1) is as follows: Implant ring body (1): the implant ring body (1) is hollow flexible cylindrical structure; Contraction spring (2): the annular structure outside of the contraction spring (2) is fixedly connected with the hollow structure inner wall of the implant ring body (1); Contraction pull rope (3): the distal end of the contraction pull rope (3) is fixedly connected with the distal end of the contraction spring (2), and the contraction pull rope (3) passes through the contraction spring (2); Limiting hole (21) is provided on the contraction spring (2), the contraction pull rope (3) passes through the limiting hole (21), and extends from the distal end to the proximal end of the contraction spring (2); The contraction spring (2) is provided with a plurality of limiting holes (21) on the same section, and a plurality of limiting holes (21) on the same section are respectively provided with independent contraction pull ropes (3); A plurality of stop blocks (31) are fixedly provided on each contraction pull rope (3), the stop block (31) is a rotary body with uniform cross-sectional area, and the cross-sectional area of the stop block (31) uniformly increases from the proximal end to the distal end. The maximum cross-sectional area of the stop block (31) is smaller than the area of the limiting hole (21). Adjusting buckle (4) is provided on the contraction pull rope (3), the adjusting buckle (4) is a hollow structure in the middle, the contraction pull rope (3) passes through the hollow structure in the middle of the adjusting buckle (4) and is movably connected with the adjusting buckle (4). The aperture of the hollow structure in the middle of the adjusting buckle (4) is variable, and the maximum cross-sectional diameter of the stop block (31) is between the maximum aperture and the minimum aperture of the hollow structure in the middle of the adjusting buckle (4). The adjusting buckle (4) comprises a frame (41), a compression spring (42) and a sliding block (43). The sliding block (43) is designed in a split type and comprises a plurality of independent parts. The outer side of the sliding block (43) is fixedly connected with the frame (41) through the compression spring (42), and the inner side of the sliding block (43) is provided with a gap hole (44). Further comprising a compression rod (6), the diameter of the compression rod (6) is smaller than the diameter of the contraction spring (2), and the compression rod (6) is used for abutting against the contraction spring (2).

2. The device of claim 1, wherein the at least one flexible member is a wire. Further comprising a plurality of propulsion rods (5), the propulsion rod (5) is a hollow rod, the propulsion rod (5) is slidably arranged on the contraction pull rope (3), the hollow aperture of the propulsion rod (5) is larger than the maximum cross-sectional diameter of the stop block (31), and the hollow aperture of the propulsion rod (5) is smaller than the outer diameter of the adjusting buckle (4).

3. The device of claim 1, wherein the at least one flexible member is a wire. Electrolytic release point (32) is provided on the contraction pull rope (3), and the electrolytic release point (32) is arranged at the proximal end of the stop block (31).

4. The device of claim 1, wherein the at least one flexible member is a wire. Anchors (7) are arranged in the implant ring body (1).

Images