Valve gap occlusion filler and filling mechanism

Abstract

The application discloses a valve gap plugging filler and mechanism, the filler comprising: a filler, which is elastically deformable, penetrates into and is positioned in a valve regurgitation gap; and a driving member, which drives and controls the whole filler to form an elastic deformation of twisting or bending, so as to plug the valve regurgitation gap. The filler can avoid damage to the valve and achieve the effect of blocking regurgitation, which is beneficial to the promotion of surgery. When the position or angle of the filler deviates from the middle of the valve or deviates from the predetermined position, the driving member can be adjusted to realize the targeted deformation of the filler in each direction, so as to achieve the purpose of plugging the valve gap and effectively blocking the blood regurgitation of the valve. The covering film on the surface of the filler can be attached to the valve, so as to further reduce the gap during attachment and achieve the effect of blocking the flow.

Description

Technical Field

[0001] This invention belongs to the field of medical device control technology, specifically relating to a valve gap occlusion filler and filling mechanism. Background Technology

[0002] The heart consists of four chambers: the left atrium, left ventricle, right atrium, and right ventricle, which connect to the aorta, aorta, pulmonary artery, and pulmonary vein, respectively. Valves exist between the ventricles and atria; the valve between the left atrium and left ventricle is called the mitral valve, and the valve between the right atrium and right ventricle is called the tricuspid valve. The heart repeatedly contracts and relaxes to move blood. During systole, blood moves from the heart to the blood vessels; in the right ventricle, blood moves towards the pulmonary artery, and in the left ventricle, blood moves towards the aorta. The heart valves have two states: when blood flows in one direction, the valves are open; when blood flows in one direction, the valves are closed. If the valves malfunction, during heart contraction, they may not close properly, potentially causing blood to flow back into the atria.

[0003] Currently, there are various solutions for abnormal heart valve function in clinical practice. The most common surgical valve repair method involves partially pulling adjacent valves together and suturing them. Specifically for the treatment of tricuspid regurgitation, existing interventional treatments for tricuspid regurgitation generally involve valve replacement or absolute margin suturing. Suturing can reduce the movement of the remaining valves, making it easier for the valves to close again and thus restoring the one-way blood flow function. However, the suturing procedure requires high precision and can cause irreversible damage to the original valves. Furthermore, mechanical and bioprosthetic valves have a limited lifespan; once problems occur, they can only be replaced or repaired surgically, which is extremely harmful to the body and significantly hinders the widespread adoption of this procedure. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a valve gap occlusion filler and mechanism to overcome the shortcomings of the prior art.

[0005] To achieve the above objectives, the present invention is accomplished through the following technical solution:

[0006] On the one hand, a valve gap occlusion packing device is provided, comprising:

[0007] The filler, which is elastically deformable, inserts into and is positioned within the valve regurgitation notch; and,

[0008] A driving element drives and controls the entire filler to form an elastic deformation of twisting or bending to seal the valve reflux gap.

[0009] The insulator deforms and bends (not simply expands) under the external force of the driving component, causing its occupied space between the valves to change.

[0010] As described in the valve gap occlusion filling mechanism, the driving member is abutted and fixed to or inside the sidewall of the filler to drive the sidewall to deform. The sidewall deformation causes the filler as a whole to undergo elastic deformation of torsion or bending.

[0011] As described in the valve gap sealing and filling mechanism, the driving component is a pull rope extending through the top end of the filler and connected to an external driving mechanism. When the pull rope is pulled, the side of the filler with the pull rope is compressed, causing the filler to bend concave towards that side, thereby adjusting the shape of the filler's cross-section between the valves to better adapt to the gap shape.

[0012] As described in the valve gap sealing and filling mechanism, the driving component is a flexible filling tube connected to an external filling mechanism. During the process of filling and emptying the filling tube, the filling tube expands and becomes firm while shrinking and becoming soft, causing the filler to bend either as a whole or partially.

[0013] As described in the valve gap sealing and filling mechanism, the driving component is a scissor-type telescopic structure, with its inner intersection point connected to the side wall of the filler. As the scissor-type telescopic structure extends and retracts, it causes the filler to bend either entirely or partially.

[0014] As described in the valve gap occlusion and filling mechanism, the driving component and the filler are integrally formed. In this case, the driving of the driving component and the deformation of the filler are maximized and synchronized.

[0015] As described in the valve gap sealing and filling mechanism, the filler is a long, thick strip or a spindle shape, which is more suitable for notch shapes.

[0016] As described in the valve gap occlusion filling mechanism, the filler is an elastomer woven from nickel-titanium wire or an inflatable elastomer. Both nickel-titanium wire weaving and inflatable molding have good resilience, allowing the deformed filler to rebound promptly after the loss of external driving force.

[0017] As described in the valve gap occlusion filling mechanism, the surface of the filler is coated to accelerate endothelialization.

[0018] As described in the valve gap occlusion and filling mechanism, the filler places the drug at the bottom end that penetrates into the valve gap, and the drug is flushed away by the turbulence of blood flow to avoid the drug being released too quickly.

[0019] On the other hand, a valve gap occlusion filling mechanism is provided, comprising a valve gap occlusion filler as described in any of the above claims, wherein the tip of the filler is anchored to the atrial wall or valve annulus tissue via an anchoring element. Anchoring assistance via the anchoring element can stabilize heart valve repair and replacement devices while minimizing damage to cardiac tissue, and avoids the use of device fixation methods that easily obstruct blood flow, thus adapting to more types of intracardiac devices.

[0020] As described in the valve gap closure and filling mechanism, the top of the filler is connected to an enlarged fixing plate, and the middle of the anchoring member has a receiving cavity. The fixing plate is fitted into the receiving cavity, and the bottom surface of the receiving cavity has a hole for the connecting part of the fixing plate to pass through. The receiving cavity also has a clamping and fixing block for pressing and fixing the fixing plate to its bottom. During installation, the disassembled fixing plate is placed into the receiving cavity, so that the connecting part of the fixing plate passes through and is fixed to the top of the filler. Then, the clamping and fixing block is installed to achieve rapid assembly of the anchoring member and the filler.

[0021] As described in the valve gap sealing and filling mechanism, the bottom surface of the receiving cavity is funnel-shaped, and the bottom surface of the fixing plate is a convex arc shape that fits the bottom surface of the receiving cavity. This allows the fixing plate to be quickly installed into the appropriate position within the receiving cavity, avoiding misalignment.

[0022] The beneficial effects of the technical solution of this invention are:

[0023] 1. Using a filler can avoid damage to the valve while simultaneously blocking regurgitation, which is conducive to the promotion of the surgery;

[0024] 2. When the position or angle of the filler deviates from the center of the valve or from the predetermined position, the filler can be adjusted by adjusting the drive component to achieve targeted deformation of the filler in various directions, thereby filling the valve gap and effectively blocking the backflow of valve blood.

[0025] 3. The coating on the surface of the filler can fit the valve, further reducing the gap during the fit and achieving a flow-blocking effect. Attached Figure Description

[0026] To further illustrate the above-mentioned objectives, structural features, and effects of the present invention, the present invention will be described in detail below with reference to the accompanying drawings.

[0027] Figure 1 This is a schematic diagram of the original structure of the filler during a tricuspid valve repair procedure according to a preferred embodiment of the present invention;

[0028] Figure 2 This is a schematic diagram of the structure of the filler after deformation and bending during a tricuspid valve repair procedure according to a preferred embodiment of the present invention (with the drive component exposed).

[0029] Figure 3 This is a schematic diagram of the structure of the filler with anchoring elements after it is deployed outside the sheath, according to a preferred embodiment of the present invention.

[0030] Figure 4 This is a schematic diagram of the working state of the filler with anchoring element inserted into the tricuspid valve according to a preferred embodiment of the present invention;

[0031] Figure 5This is a schematic diagram of the connection structure between the top of the filler and the anchor in a preferred embodiment of the present invention;

[0032] In the diagram: 1. Filler; 2. Drive unit; 3. Anchor unit; 4. Fixing plate; 5. Receiving cavity; 6. Hole; 7. Clamping block; 8. Sheath. Detailed Implementation

[0033] The terms “invention,” “this invention,” and “the present invention” used in this specification are intended to broadly refer to all subject matter of this specification and any of the following patent claims. Statements containing these terms should not be construed as limiting the subject matter described herein or limiting the meaning or scope of any of the following patent claims. Furthermore, this specification does not attempt to describe or limit the subject matter covered by any claim of any particular component, paragraph, statement, or drawing of this application. The subject matter should be understood with reference to the entire specification, all drawings, and any of the following claims. The invention may have other embodiments and be practiced or implemented in other ways. Moreover, it should be understood that the wording and terminology used herein are for illustrative purposes and should not be considered limiting.

[0034] The details of the invention will now be discussed with reference to the accompanying drawings, which are illustrated by way of example only. In the drawings, similar features or components may be labeled using the same reference numerals.

[0035] The use of the terms "comprising," "having," and "including," and variations thereof, herein means to include the items listed herein and their equivalents and additional items. While reference may be made in the description of the drawings to directions such as above, below, upward, downward, backward, bottom, top, front, rear, etc., for convenience, reference is made relative to the drawings (as in normal observation). These directions are not intended to literally accept or limit the invention in any form. Furthermore, terms such as "first," "second," "third," etc., are used herein for illustrative purposes and are not intended to indicate or imply importance or significance.

[0036] The overall design concept of this invention is to provide a control driving force to the filler to cause it to twist and / or bend. This can increase its projected area on the plane of the valve regurgitation notch after deformation, and adjust the projected position of the filler on the plane of the valve regurgitation notch.

[0037] See Figures 1 to 4As shown, the present invention provides a valve gap occlusion filler, specifically including a filler 1 and a driving member 2. The filler 1 is elastically deformable and is inserted into and positioned in the valve regurgitation gap (the gap space formed between abnormal valves after the valves come together is the regurgitation gap). The driving member 2 drives and controls the filler 1 to form an elastic deformation of torsion or bending. The filler 1 deforms and bends (not simply expands) under the external force of the driving member 2, so that the space it occupies between the valves changes, thereby sealing the valve regurgitation gap.

[0038] Furthermore, the driving component 2 is abutted and fixed to or inside the side wall of the filler 1 to drive the side wall to deform. The deformation of the side wall causes the filler as a whole to undergo elastic deformation of torsion or bending.

[0039] Regarding a preferred embodiment of the filler 1, in terms of shape, the filler 1 can be a long, thin strip or a spindle shape. In terms of material, the filler 1 can be an elastomer woven from nickel-titanium wire or an inflatable elastomer. Both nickel-titanium wire weaving and inflatable molding have good resilience, allowing the deformed filler 1 to rebound promptly after losing external driving force. It should be understood that the structural styles obtained by arranging and combining the above-mentioned shapes and materials of the filler 1 are all within the protection scope of this invention.

[0040] Furthermore, the surface of the inflator 1 is coated, such as with PET film, to accelerate endothelialization. The inflator 1 has a drug delivery positioned at its bottom end, which is penetrated into the valve space; the drug is flushed away by the turbulence of the blood flow, preventing excessively rapid drug release.

[0041] In a preferred embodiment of the drive element 2, the drive element 2 is a pull rope that extends through the top of the filler 1 and connects to an external drive mechanism. When the pull rope is pulled, the side of the filler 1 with the pull rope is compressed, causing the filler 1 to bend concave towards that side, thereby adjusting the shape of the cross-section of the filler 1 between the valves to better adapt to the notch shape.

[0042] In a preferred embodiment of the filler 1, applied in tricuspid valve repair, the filler 1 can be a long, thin elastomer surrounded by an expanded mesh with a surface coating. The expanded mesh can be a one-piece woven structure or composed of several woven structures spliced ​​together. The woven structure uses shape memory elastic material or a polymer. The one-piece structure allows the actuation of the drive element 2 and the deformation of the filler 1 to achieve maximum synchronization. The elastomer is vertically inserted between the valves. The sidewall of the elastomer is provided with at least one pull cord (as the drive element 2) for pulling the expanded mesh. One end of the pull cord is fixed to the middle or lower part of the elastomer, and the other end is connected to an external traction mechanism. Generally, the pull cord can extend along the length of the elastomer in a straight needle pattern between the meshes. When the pull cord is pulled, part of the affected mesh of the elastomer is compressed, causing the elastomer to bend towards that part, thereby adjusting the position of the elastomer's cross-section between the valves to better adapt to the notch shape.

[0043] In mitral valve repair, the filler 1 is spindle-shaped for transverse placement between the valves. The filler 1 is inserted between the valves. A pull cord (acting as a drive element 2) is provided on the sidewall of the elastomer for tightening and shrinking the filler. One end of the pull cord is fixed to the sidewall of the filler 1, and the cord extends approximately along the long axis of the spindle shape and connects to an external traction mechanism. When the pull cord is pulled, the side of the elastomer with the pull cord is compressed, causing the elastomer to bend concave towards that side, thereby adjusting the shape of the elastomer's cross-section between the valves to better adapt to the notch shape.

[0044] In a preferred embodiment of the driving component 2, the driving component 2 is a flexible filling tube connected to an external filling mechanism. During the filling and emptying process of the filling tube, the tube expands and becomes firm while shrinking and becoming soft, causing the filler 1 to bend either entirely or partially during the transformation. Here, the driving component 2 and the filler 1 are integrally formed, which allows the driving of the driving component 2 and the deformation of the filler 1 to achieve maximum synchronization.

[0045] In a preferred embodiment of the driving component 2, the driving component 2 is a scissor-type telescopic structure, with its inner intersection point connected to the side wall of the filler 1. As the scissor-type telescopic structure extends and retracts, it causes the filler 1 to bend, either entirely or partially.

[0046] The present invention also provides a valve gap sealing and filling mechanism, see below. Figure 5 As shown, the device includes a valve gap occlusion filler as described above. The tip of the filler 1 is anchored to the atrial wall or valve annulus tissue via an anchor 3. Anchoring with the anchor 3 helps stabilize heart valve repair and replacement devices while minimizing damage to cardiac tissue. It also avoids using device fixation methods that easily obstruct blood flow, and is compatible with a wider range of cardiac devices.

[0047] Continue reading Figure 5 As shown, the top of the filler 1 is connected to an enlarged fixing plate 4, and the middle of the anchor 3 is provided with a receiving cavity 5. The fixing plate 4 is snapped into the receiving cavity 5, and the bottom surface of the receiving cavity 5 has a hole 6 for the connecting part of the fixing plate 4 to pass through. The receiving cavity 5 is also provided with a clamping and fixing block 7 for pressing and fixing the fixing plate 4 to its bottom. During installation, the disassembled fixing plate 4 is placed into the receiving cavity 5, so that the connecting part of the fixing plate 4 passes through and is fixed to the top of the filler 1. Then, the clamping and fixing block 7 is installed to achieve quick assembly of the anchor 3 and the filler 1.

[0048] Furthermore, the bottom surface of the receiving cavity 5 is funnel-shaped, and the bottom surface of the fixing plate 4 is a convex arc shape that fits the bottom surface of the receiving cavity 5. This allows the fixing plate 4 to be quickly installed into the appropriate position within the receiving cavity 5, preventing misalignment. In addition, the funnel and convex arc shapes mentioned here may have corresponding edges or limits on their surface structure to facilitate positioning and prevent accidental rotation.

[0049] The working process of this invention is as follows:

[0050] In tricuspid valve repair surgery, an expanded filler 1, equipped with an anchor 3 and a drive 2, is inserted and deployed between the tricuspid valves. By observing the relative position of the filler 1 and the tricuspid valve space using ultrasound, the space not fully covered by the filler 1 is located. A pull-cord type drive 2 is selected near this space, and the drive 2 is adjusted by the pull cord, causing the tail of the filler 1 to swing towards that side, thereby increasing its projected area between the valves to further fill and cover the incomplete space.

[0051] The entire process of the device is as follows: the sheath 8 containing the filler 1 is inserted into the designated position, the filler 1 is pushed out of the sheath 8 and expands, and the filler 1 is further pushed so that the anchor 3 behind it is moved out of the sheath and anchored to the atrium or valve annulus by tension. After the shape of the filler 1 is stabilized to a better shape by the drive 2, the tail end of the pull rope drive 2 is fixed to the anchor 3, disengaging and withdrawing from the sheath 8, thus completing the operation.

[0052] This invention uses a filler that avoids damage to the valve while simultaneously blocking regurgitation, facilitating surgical application. When the filler's position or angle deviates from the center of the valve or from the predetermined position, the drive mechanism can be adjusted to achieve targeted deformation of the filler in various directions, effectively filling the valve gap and blocking blood regurgitation. The coating on the filler's surface can conform to the valve, further reducing the gap during conformation and achieving a flow-blocking effect.

[0053] The above are merely preferred embodiments of the present invention and are not intended to limit the implementation methods and protection scope of the present invention. Those skilled in the art should recognize that any equivalent substitutions and obvious changes made based on the description and illustrations of the present invention should be included within the protection scope of the present invention.

Claims

1. A valve gap occlusion packer, characterized in that, include: A long, thin strip or spindle-shaped filler (1) can be elastically deformed, inserted into and positioned in the valve regurgitation notch; as well as, The driving element (2) drives and controls the filler (1) to form an elastic deformation of twisting or bending to seal the valve reflux gap; The driving component (2) is attached to or fixed to the side wall of the filler (1) to drive the side wall to deform. When the position or angle of the filler deviates from the center of the valve or from the predetermined position, the filler (1) can be deformed in various directions by adjusting the drive (2).

2. The valve gap occlusion filler as described in claim 1, characterized in that, The drive element (2) is a pull rope that extends through the top of the filler (1) and connects to an external drive mechanism.

3. The valve gap occlusion packer as described in claim 1, characterized in that, The driving component (2) is a flexible filling tube that connects to an external filling mechanism.

4. The valve gap occlusion packer as described in claim 1, characterized in that, The drive unit (2) is a scissor telescopic structure, and its inner intersection point is connected to the side wall of the filler (1).

5. The valve gap occlusion packer as described in claim 1, characterized in that, The drive component (2) is integrally formed with the filler (1).

6. The valve gap occlusion packer as described in claim 1, characterized in that, The filler (1) is an elastomer woven from nickel-titanium wire or an inflatable elastomer.

7. The valve gap occlusion packer as described in claim 1, characterized in that, The surface of the filler (1) is coated.

8. The valve gap occlusion packer as described in claim 1, characterized in that, The filler (1) places the drug at the bottom end that penetrates the valve space.

9. A valve gap sealing and filling mechanism, characterized in that, Includes the valve gap occlusion filler as described in any one of claims 1 to 8, wherein the top of the filler (1) is anchored to the atrial wall or valve annulus tissue by an anchor (3).

10. The valve gap sealing and filling mechanism as described in claim 9, characterized in that, The top of the filler (1) is connected to an enlarged fixing plate (4), and the middle part of the anchor (3) is provided with a receiving cavity (5). The fixing plate (4) is locked in the receiving cavity (5). The bottom surface of the receiving cavity (5) is provided with a hole (6) for the connecting part of the fixing plate (4) to pass through. The receiving cavity (5) is also provided with a pressing and fixing block (7) for pressing and fixing the fixing plate (4) to its bottom.

11. The valve gap sealing and filling mechanism as described in claim 10, characterized in that, The bottom surface of the accommodating cavity (5) is funnel-shaped, and the bottom surface of the fixing plate (4) is a convex arc shape that fits the bottom surface of the accommodating cavity (5).

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