A device that repairs tricuspid regurgitation by flexing the chordae tendineae

Abstract

The present invention discloses a device for repairing tricuspid regurgitation by accordion chordae tendineae, comprising: a chord-gathering member for wrapping around and accordion-gathering the chordae tendineae; a fixing member connected to the chord-gathering member for positioning the device for repairing tricuspid regurgitation by accordion chordae tendineae; and a counterweight block at the connection between the chord-gathering member and the fixing member for stabilizing the chord-gathering member. The present invention effectively prevents the device for repairing tricuspid regurgitation by accordion chordae tendineae from moving upward by adding a counterweight block between the accordion-gathering hollow rod of the chord-gathering member and the fixing member. The position of the counterweight block can be adjusted to adjust the center of gravity of the device for repairing tricuspid regurgitation by accordion chordae tendineae, further stabilizing the device and improving its fit with the heart, such as the atrial wall. Furthermore, the counterweight block is connected to the accordion-gathering hollow rod and the fixing hollow rod via threads, allowing the position of the counterweight block to be adjusted in advance according to the patient's heart shape.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a device for repairing tricuspid valve regurgitation by retracting chordae tendineae. Background Art

[0002] The heart's primary function is to guide blood flow into and out of its chambers by contracting or expanding the corresponding valves, opening or closing them. The tricuspid valve, located between the right atrium and right ventricle, functions properly. A normal tricuspid valve ensures that incoming blood flows from the right atrium to the right ventricle and prevents backflow.

[0003] Functional tricuspid regurgitation is often caused by valvular disease in the left heart system, leading to left atrial enlargement, which in turn causes pulmonary hypertension and right ventricular enlargement. This in turn causes the tricuspid annulus to expand, altering the mechanical direction of the chordae tendineae pulling on the valve, resulting in poor leaflet coaptation and tricuspid regurgitation. When moderate to severe tricuspid regurgitation is present before surgery, the tricuspid valve apparatus inevitably exhibits significant pathological structural changes.

[0004] Currently, the commonly used methods for repairing the tricuspid valve are edge-to-edge repair and repair through chordae tendineae. Among them, chordae tendineae repair is less damaging to the heart valve because it is in soft contact with the chordae tendineae and does not completely restrict their movement. However, the existing chordae tendineae generally use a spiral winding method to gradually gather the chordae tendineae near the center of the spiral disk to repair the tricuspid valve. For example, publication numbers CN110352045A, CN106901875B, and CN107072782B all involve tricuspid valve regurgitation repair devices with a spiral winding method. However, during the later use of these devices, on the one hand, due to the shaking of the heart valve, there is a situation where the tricuspid valve regurgitation repair device may fall out. On the other hand, there is a technical problem that the chordae tendineae will expand outward near the leaflet position, and during the opening and closing process of the leaflet, it will drive the repair device to move upward, so it is necessary to improve it. Summary of the Invention

[0005] The present invention addresses the technical problem in the prior art that the valve leaflets will drive the repair device to move upward during the opening and closing process, and aims to provide a new device for repairing tricuspid valve regurgitation by retracting the chordae tendineae. The device for repairing tricuspid valve regurgitation by retracting the chordae tendineae of the present invention prevents the device from moving upward by retracting the chordae tendineae by adding a counterweight block.

[0006] The device for repairing tricuspid valve regurgitation by folding the chordae tendineae is invented, comprising:

[0007] a tendon gatherer for winding the tendons and gathering the tendons;

[0008] The proximal end of the tendon cord gatherer is further provided with a counterweight block for stabilizing the tendon cord gatherer.

[0009] Preferably,

[0010] The center of the tendon cord gathering member is provided with a gathering rod in a nearly vertical state, and the proximal portion of the gathering rod is provided with a gathering rod thread;

[0011] The distal end of the counterweight can be freely configured to be connected to different positions of the furling rod thread of the furling rod.

[0012] Preferably, the device for repairing tricuspid valve regurgitation by retracting chordae tendineae further comprises a fixing member connected to the proximal end of the chordae tendineae retracting member for positioning the device for repairing tricuspid valve regurgitation by retracting chordae tendineae.

[0013] Preferably, the center of the fixing member has a fixing rod in a nearly vertical state, and the distal end of the fixing rod has a fixing rod thread;

[0014] The proximal end of the counterweight can be freely configured to be connected to different positions of the fixing rod thread of the fixing rod.

[0015] Preferably,

[0016] The center of the tendon cord gathering member is provided with a gathering rod in a nearly vertical state, and the proximal portion of the gathering rod is provided with a gathering rod thread;

[0017] The distal end of the counterweight can be freely configured to be connected to different positions of the furling rod thread of the furling rod.

[0018] Preferably, the retracting rod and the fixing rod are integrally formed.

[0019] The folding rod is a folding hollow rod; the fixing rod is a fixing hollow rod.

[0020] Preferably, a tendon cord anti-falling piece is further provided in the tendon cord gathering piece.

[0021] Preferably, the tendon chord anti-detachment member has a thread and barbs spaced apart on the thread, the thread is passed through the hollow interior of the tendon chord gathering member, and the barbs can freely pass through the side walls of the tendon chord gathering member to prevent the tendons from escaping during cardiac contraction and expansion.

[0022] Preferably,

[0023] The middle section of the tendon cord gathering member is a spirally wound ring with a hollow interior. The proximal end of the spirally wound ring is connected to a hollow gathering rod. The side wall of the spirally wound ring is penetrated by a plurality of through holes, which are connected to the interior of the spirally wound ring.

[0024] The silk thread is sequentially passed through the retracted hollow rod and the spirally wound ring, and the barbs can freely pass through the through holes of the spirally wound ring.

[0025] Preferably, the proximal end of the spiral winding ring has a spiral center, which is connected to the retracting hollow rod through the spiral center, and a spiral ring extends integrally with the spiral center as the starting point. A path for retracting the tendons is formed between the spiral rings, the silk thread is passed through the inside of the spiral ring, and the through hole is arranged on the side wall of the spiral ring.

[0026] Preferably, the distal end of the spirally wound ring has a safety cap, and an elastic member is fixed inside the safety cap.

[0027] Preferably, the proximal end of the wire is fixed to the proximal end of the counterweight or to the fixed hollow rod of the fixing member, and the distal end of the wire is connected to the distal end of the spiral winding ring through the elastic member.

[0028] Preferably, the fixing member has a rotating disk having a disk center, the rotating disk is connected to the fixed hollow rod via the disk center, and the proximal end of the wire is connected to the fixed hollow rod near the disk center.

[0029] Preferably, the turntable is a spiral disk structure that is approximately flat.

[0030] Preferably, the rotating disk is a spiral disk structure that is approximately spherical.

[0031] Preferably, the rotating disk is a spiral disk structure that is approximately conical.

[0032] The positive progress effect of the present invention is:

[0033] 1) The present invention effectively prevents upward movement of the device for repairing tricuspid regurgitation via chordae tendineae by adding a counterweight between the retracting hollow rod of the chordae tendineae retracting member and the fixed hollow rod of the fixing member. Furthermore, a retracting rod thread is provided at the proximal end of the retracting hollow rod, and a fixed rod thread is provided at the distal end of the fixed hollow rod. The position of the counterweight can be adjusted back and forth on the threads to adjust the center of gravity of the device for repairing tricuspid regurgitation via chordae tendineae retracting, further stabilizing the device and improving its fit with the heart, such as the atrial wall.

[0034] 2) The present invention, by providing a chordal retainer within the chordal retainer, can significantly prevent chordae from being dislodged during a device for repairing tricuspid regurgitation by retracting chordae. Specifically, the chordal retainer's thread controls the direction of movement of the barbs, preventing the chordae from escaping their intended position. Furthermore, the thread and barbs of the chordal retainer are movably positioned within the internal cavity of the chordal retainer, allowing the chordal retainer to be withdrawn from its spirally wound loop during subsequent use, depending on the patient's needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 This is a schematic diagram of the three-dimensional structure of a device for repairing tricuspid valve regurgitation by folding chordae tendineae according to an embodiment of the present invention;

[0036] Figure 2 Schematic diagram of the three-dimensional structure of the tendon cord anti-detachment member 20 of the present invention;

[0037] Figure 3 This is a schematic diagram of another configuration structure of the distal end of the spirally wound ring 12 of the present invention;

[0038] Figure 4 This is a schematic structural diagram of a configuration mode of the wire 21 of the present invention;

[0039] Figure 5 This is a schematic diagram of the three-dimensional structure of a device for repairing tricuspid valve regurgitation by folding chordae tendineae according to another embodiment of the present invention;

[0040] Figure 6 for Figure 5 A schematic diagram of the three-dimensional structure of the device for repairing tricuspid valve regurgitation by folding chordae tendineae in accordance with an embodiment of the present invention from another angle;

[0041] Figure 7 for Figure 5 A schematic diagram of the three-dimensional structure of the fixing member 30 of the embodiment;

[0042] Figure 8 A schematic diagram of the three-dimensional structure of the configuration of the wire 21;

[0043] Figure 9 for Figure 5 A schematic diagram of a three-dimensional structure of a device for repairing tricuspid regurgitation by folding chordae tendineae in an embodiment of the present invention in which a counterweight 40 is threadedly connected;

[0044] Figure 10 for Figure 5 A schematic diagram of the three-dimensional structure of the proximal installation design of the wire 21 of the embodiment;

[0045] Figure 11 for Figure 5 A schematic diagram of the three-dimensional structure of the fixing member 30 of the embodiment;

[0046] Figure 12 This is a schematic diagram of the three-dimensional structure of a device for repairing tricuspid valve regurgitation by folding chordae tendineae according to another embodiment of the present invention;

[0047] Figure 13 for Figure 12 A schematic diagram of the three-dimensional structure of the device for repairing tricuspid valve regurgitation by folding chordae tendineae in accordance with an embodiment of the present invention from another angle;

[0048] Figure 14 This is a schematic diagram of the three-dimensional structure of a device for repairing tricuspid valve regurgitation by folding chordae tendineae according to yet another embodiment of the present invention;

[0049] Figure 15 for Figure 14 A schematic diagram of the three-dimensional structure of the device for repairing tricuspid valve regurgitation by folding chordae tendineae in accordance with an embodiment of the present invention from another angle;

[0050] Figure 16 for Figure 14 A schematic cross-sectional view of the tendon cord preventing member 20 within the tendon cord gathering member 10 according to an embodiment. DETAILED DESCRIPTION

[0051] like Figures 1-2 As shown, in a preferred embodiment of the present invention, the device for repairing tricuspid valve regurgitation by gathering the chordae tendineae includes a chordae tendineae gathering member 10. The chordae tendineae gathering member 10 is a spiral structure that is generally approximately flat and is used to wind the chordae tendineae and gradually gather the chordae tendineae toward the center of the chordae tendineae gathering member 10. When in use, it is located in the ventricle of the heart. A chordae tendineae anti-detachment member 20 is also provided in the chordae tendineae gathering member 10.

[0052] Continue as Figures 1-2 As shown, the proximal center of the tendon gathering member 10 comprises a nearly vertical gathering hollow rod 11 and a spirally wound ring 12. The tendon gathering member 10 may be made of nickel-titanium alloy wire. The angle formed between the gathering hollow rod 11 and the spirally wound ring 12 can range from 60° to 120°, such as 70°, 80°, 90°, 100°, and so on. The cross-section of the gathering hollow rod 11 is elliptical. The spirally wound ring 12 is hollow within a hollow structure. The proximal end of the spirally wound ring 12 has a spiral center 121, which is connected to the gathering hollow rod 11 through the spiral center 121. A spiral ring 122 spirally extends outward from the proximal spiral center 121 of the spirally wound ring 12. The helix angle of the spiral ring 122 can be zero, positive, or negative. The diameter of the helix formed by the spiral ring 122 can range from 5 mm to 20 mm, preferably from 7 mm to 16 mm, and more preferably from 8 mm to 12 mm. A path 123 for gathering the tendons is formed between the spiral rings 122. During the gathering process of the tendons, the tendons are confined within the path 123 and are gathered by moving spirally along the path 123. For each circle of the spiral ring, the inner wall is the side with a smaller diameter, and the outer wall is the side with a larger diameter. A number of through holes are passed through the inner and outer walls of the spiral ring 122, and the through holes are connected to the interior of the spiral winding ring 12. The through holes are arranged on the inner or outer wall of the spiral ring and point to the path 123. A protective member is provided at the distal end of the spiral winding ring 12, which may be a safety cap 124, or may be formed by bending the distal end of the spiral ring 122 outward or inward to form a blunter end, such as Figures 3-4As shown, the spiral winding ring 12 is prevented from damaging the tendon due to the sharp tip when the tendon is wound around it; a better example is that the tail end of the safety cap 124 is tangent to the ring tube of the spiral winding ring 12 so that it can be connected without any obstacles. Figure 3 As shown, the safety cap 124 can be welded, threaded, or snap-fitted to the distal end of the spirally wound ring 12. In other embodiments, to ensure that the pull wire is in a tensioned state, an elastic member, such as a spring 125, can be fixed within the safety cap 124, which is connected to the wire 21 located within the spirally wound ring 12 via the spring 125.

[0053] The tendon cord anti-slip member 20 comprises a wire 21 and barbs 22 arranged at intervals on the wire. The wire 21 is sequentially inserted into the interior of the retracted hollow rod 11 and the hollow interior of the spiral ring 122 of the spiral winding ring 12. The barbs 22 can freely pass through the through holes of the spiral ring 122 on the spiral winding ring 12. During use, the barbs 22 can be partially pushed to the outside of the spiral winding ring 12 or pulled to the inside of the spiral winding ring 12 as needed. The deflection angle of the barbs 22 is 20° to 180°. The deflection direction of the barbs is the same as or opposite to the direction of the spiral winding ring 12. The distal end of the wire 21 is connected to the spring 125 in the distal safety cap 124 of the spiral winding ring 12. The proximal end of the wire 21 is fixedly connected to the limit block 112 of the proximal limit plate 111 of the retracted hollow rod 11 to fix the distal end of the wire 21. Another embodiment is that the proximal end of the wire 21 can be set on the counterweight 40, such as Figure 4 shown.

[0054] In order to fix the tendon chord anti-slip part 20, a limiting disk 111 can be provided at the proximal end of the hollow gathering rod 11 at the proximal end of the tendon chord gathering part 10. The limiting disk 111 can be conical, or a quadrilateral with an arc angle, or a cylindrical shape with an arc angle, or a sphere. The limiting disk 111 is rigidly connected to the proximal end of the hollow gathering rod 11. The limiting disk 111 has a groove. The shape of the groove can be circular, square, spherical, polygonal, rhombus or triangular. A limiting block 112 is provided in the groove. By providing the tendon chord anti-slip part 20 in the tendon chord gathering part 10, it is possible to effectively prevent the tendons from slipping out of the device during the process of the tendons shaking with the expansion and contraction of the heart. Specifically, the direction of movement of the barbs is controlled by the silk thread of the tendon chord anti-slip part 20. The tendons confined within the path 123 are blocked by the barbs 22, thereby preventing the tendons from escaping the predetermined position. Moreover, the silk thread 21 and the barb 22 of the tendon chord anti-detachment part 20 are movably arranged in the internal cavity of the tendon chord gathering part. During subsequent use, if the device needs to be withdrawn from the patient's body, the angle between the barb 22 and the spiral winding ring 12 can be changed by adjusting the tension of the silk thread to open the path 123, so that the device can be separated from the tendon.

[0055] Continue as Figures 5-11 and Figure 16As shown, in another embodiment of the present invention, the device for repairing tricuspid regurgitation by accordion traction includes a fixing member 30 connected to the chordal accordion accordion accordion member 10 for positioning the device for repairing tricuspid regurgitation by accordion accordion accordion. During use, the fixing member 30 is located in the atrium of the heart and can be made of a nickel-titanium alloy. A counterweight 40 is provided at the connection between the chordal accordion accordion member 10 and the fixing member 30 to stabilize the chordal accordion accordion member 10. The counterweight can be cylindrical, spherical, ellipsoidal, elliptical, quadrilateral with a corner safety feature, hexagonal with a corner safety feature, polygonal with a corner safety feature, etc. The counterweight is made of a self-expanding polyurethane material or a nickel-titanium alloy. A nearly vertical fixed hollow rod 31 is provided at the center of the fixing member 30. The ends of the counterweight 40 are fixedly connected to the accordion hollow rod 11 and the fixed hollow rod 31, respectively. Preferably, the distal end of the fixed hollow rod 31 has a fixed rod thread, and the proximal end of the counterweight 40 can be freely configured to be connected to different positions of the fixed rod thread of the fixed hollow rod 31. The proximal end of the folding hollow rod 11 has a folding rod thread, and the distal end of the counterweight 40 can be freely configured to be connected to different positions of the folding rod thread of the folding hollow rod 11. Moreover, the folding hollow rod 11 and the fixed hollow rod 31 can be integrally formed. A folding rod thread is provided at the proximal end of the folding hollow rod 11, and a fixed rod thread is provided at the distal end of the fixed hollow rod 31. The position of the counterweight 40 can be arbitrarily adjusted back and forth on the thread to achieve the purpose of adjusting the center of gravity of the device for repairing tricuspid valve regurgitation by folding chordae tendineae, further stabilizing the stability of the device for repairing tricuspid valve regurgitation by folding chordae tendineae, and increasing the fit between the device for repairing tricuspid valve regurgitation by folding chordae tendineae and the heart, such as the atrial wall. A counterweight 40 is added between the hollow collecting rod 11 of the tendon collecting member 10 and the hollow fixed rod 31 of the fixing member 30. This effectively prevents the device for repairing tricuspid regurgitation by collecting the tendons from moving upward during cardiac operation. The counterweight 40 can be located within the atrium or the ventricle.

[0056] The fixing member 30 has a rotating disk 32, which has a center. The rotating disk 32 is connected to the fixed hollow rod 31 through the center. The proximal end of the wire 21 is connected to the fixed hollow rod 31 near the center. The fixing member of the present invention also has multiple implementation schemes, such as Figures 3 to 9 As shown, the disk 32 is a spiral disk structure that is approximately flat. This structure is similar to the spiral winding ring 12. The end of the spiral disk structure also has a safety cap structure. The helical angle of the spiral line of the spiral disk structure can be 0°, a positive angle, or a negative angle. The helical angle at the farthest end of the spiral line is the largest. The spiral diameter of the spiral line of the spiral disk structure is 10 to 30 mm, preferably 15 to 20 mm, and more preferably 16 to 18 mm. Figure 12 、 13 As shown, the spiral disk 32 is a spiral disk structure that is approximately spherical, with two ends of the spiral disk. Figure 14 、 15 As shown, the rotating disk 32 is a spiral disk structure that is approximately conical.

[0057] The steps of a preferred embodiment of using the device provided by the present invention for repairing tricuspid valve regurgitation by folding chordae tendineae are as follows:

[0058] Step 1: The guidewire punctures the right femoral vein. The catheter sheath and catheter enter the right femoral vein along the guidewire and exit the catheter sheath to form a pathway.

[0059] Step 2: A delivery device, which is pre-pressed with the device for repairing tricuspid regurgitation by gathering chordae tendineae provided by the present invention, is introduced into the right atrium through a catheter. The distal end of the delivery device (the side away from the operator) is controlled in direction so that the distal end crosses the tricuspid valve and enters the right ventricle. The device is gradually released to a free state. The angle of the barbs on the silk thread is controlled by a handle so that the barbs are opened to a suitable position to facilitate the passage of the chordae tendineae. The operating handle is rotated to gradually gather the chordae tendineae in the right ventricle toward the center of the chordae tendineae gathering device. After the gathering is completed, the barbs are released so that the chordae tendineae will not escape due to the contraction or relaxation of the heart during operation.

[0060] Step 3: Gradually withdraw the conveyor, release the counterweight and the fixing piece, and fix the device on the inner wall of the right atrium.

[0061] Step 4: After confirming that the device is installed properly, withdraw the conveyor and complete the operation.

[0062] The present invention has been described in detail above with reference to the embodiments of the accompanying drawings. A person skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention. The scope of protection of the present invention shall be determined by the scope defined by the appended claims.

Claims

1. A device for repairing tricuspid valve regurgitation by flexing chordae tendineae, comprising: a tendon gatherer for winding the tendons and gathering the tendons; The feature is that the proximal end of the tendon cord gathering piece is further provided with a counterweight block for stabilizing the tendon cord gathering piece; A tendon cord anti-falling piece is also provided in the tendon cord gathering piece; The center of the tendon cord gathering member is provided with a gathering rod in a nearly vertical state, and the proximal portion of the gathering rod is provided with a gathering rod thread; The distal end of the counterweight block can be freely configured to be connected to different positions of the furling rod thread of the furling rod; The chordal anti-slip component has a thread and barbs spaced apart on the thread. The thread is passed through the hollow interior of the chordal gatherer, and the barbs can freely pass through the side walls of the chordal gatherer to prevent the chordae from escaping during cardiac contraction and expansion.

2. The device for repairing tricuspid valve regurgitation by folding the chordae tendineae as claimed in claim 1, characterized in that The device for repairing tricuspid valve regurgitation by retracting chordae tendineae also includes a fixing member connected to the proximal end of the chordae tendineae retracting member for positioning the device for repairing tricuspid valve regurgitation by retracting chordae tendineae.

3. The device for repairing tricuspid valve regurgitation by folding the chordae tendineae as claimed in claim 2, characterized in that The center of the fixing member is provided with a fixing rod in a nearly vertical state, and the distal end of the fixing rod is provided with a fixing rod thread; The proximal end of the counterweight can be freely configured to be connected to different positions of the fixing rod thread of the fixing rod.

4. The device for repairing tricuspid regurgitation by accumulating chordae tendineae according to claim 3, wherein: The folding rod is a folding hollow rod; and / or the fixing rod is a fixing hollow rod.

5. The device for repairing tricuspid regurgitation by accumulating chordae tendineae according to claim 3, wherein: The retracting rod and the fixing rod are integrally formed.

6. The device for repairing tricuspid regurgitation by accumulating chordae tendineae according to claim 1, wherein: The middle section of the tendon cord gathering member is a spirally wound ring with a hollow interior. The proximal end of the spirally wound ring is connected to a hollow gathering rod. The side wall of the spirally wound ring is penetrated by a plurality of through holes, which are connected to the interior of the spirally wound ring. The silk thread is sequentially passed through the retracted hollow rod and the spirally wound ring, and the barbs can freely pass through the through holes of the spirally wound ring.

7. The device for repairing tricuspid regurgitation by accumulating chordae tendineae according to claim 6, characterized in that: The proximal end of the spiral winding ring has a spiral center, which is connected to the retracted hollow rod through the spiral center. A spiral ring extends integrally with the spiral center as the starting point. A path for retracting the tendons is formed between the spiral rings. The silk thread is passed through the inside of the spiral ring, and the through hole is arranged on the side wall of the spiral ring.

8. The device for repairing tricuspid valve regurgitation by folding chordae tendineae as claimed in claim 7, characterized in that The distal end of the spirally wound ring is provided with a safety cap, and an elastic member is fixed inside the safety cap.

9. The device for repairing tricuspid valve regurgitation by folding chordae tendineae as claimed in claim 2, characterized in that The proximal end of the silk thread is fixed to the proximal end of the counterweight or to the fixed hollow rod of the fixing member.

10. The device for repairing tricuspid valve regurgitation by folding chordae tendineae according to claim 6, characterized in that The distal end of the silk thread is connected to the distal end of the spirally wound ring through an elastic member.

11. The device for repairing tricuspid valve regurgitation by folding chordae tendineae according to claim 4, characterized in that The fixing member has a rotating disk with a disk center. The rotating disk is connected to the fixed hollow rod via the disk center. The proximal end of the wire is connected to the fixed hollow rod near the disk center.

12. The device for repairing tricuspid valve regurgitation by folding chordae tendineae according to claim 11, characterized in that The rotating disk is a spiral disk structure that is approximately flat.

13. The device for repairing tricuspid valve regurgitation by folding chordae tendineae according to claim 11, characterized in that The rotating disk is a spiral disk structure that is approximately spherical.

14. The device for repairing tricuspid valve regurgitation by folding chordae tendineae according to claim 11, characterized in that The rotating disk is a spiral disk structure that is approximately conical.

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