A forming device with locally contractible rings

Abstract

The application relates to the field of medical devices, in particular to a shaping device capable of locally shrinking a ring, which comprises a ring shrinking frame, a fixing unit, the fixing unit being used for piercing into a valve ring tissue to realize anchoring, at least two tissue pressing pieces, each of the tissue pressing pieces having a fixed end and a free end, the fixed end being connected to the ring shrinking frame, and the tissue pressing piece being configured to have a preset bending shape, in the preset shape, the free end deflects downward relative to the fixed end, and a control wire, the control wire being detachably connected with the tissue pressing piece, wherein the control wire controls the release of the tissue pressing piece, and when the control wire is disconnected with the tissue pressing piece, the tissue pressing piece restores to the preset bending shape, and the fixed ends of the tissue pressing pieces approach to each other; in the application, the shaping device can realize local ring shrinking, and the tissue pressing pieces press downward on the valve ring tissue, without affecting other heart tissues.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a forming device for locally shrinkable rings. Background Technology

[0002] In vertebrates, the heart is a hollow muscular organ with four pumping chambers: the left and right atria and the left and right ventricles, each equipped with its own one-way valve. Naturally occurring heart valves are identified as the aortic valve, mitral valve, tricuspid valve, and pulmonary valve, each anchored in an annulus comprising a dense fibrous ring directly or indirectly connected to the atrioventricular myocardial fibers. Each annulus defines a flow orifice.

[0003] The common treatment for mitral regurgitation is valvular repair surgery. Under cardiopulmonary bypass, surgeons repair the damaged heart valve and correct the enlarged annulus, thus treating mitral regurgitation. To maintain long-term therapeutic effects, after valvular repair surgery, surgeons often implant an artificial annuloplasty ring in the annulus location to ensure proper shaping of the original annulus and prevent further enlargement, thus maintaining the treatment effect. The annuloplasty ring is tightened using sutures. However, this suture tightening procedure only reduces the distance between anchoring / needle points, leading to noticeable wrinkles in the tissue above the tightening device, uneven annuloplasty, and potential torsion of the coronary arteries and other vessels attached to the outer wall of the heart, causing complications. For example, US patent 20210275306A1 discloses an exemplary method for performing a valve repair procedure, including introducing a catheter into the left atrium of the heart, deploying a first component from the catheter, anchoring the first component to the posterior side of the mitral valve annulus in the left atrium, deploying a second component from the catheter, anchoring the second component to the anterior side of the mitral valve annulus in the left atrium, deploying a flexible tensile member from the catheter, connecting the tensile member to the first and second components, and applying tension to the tensile member to pull the first and second components toward each other and bring the posterior and anterior sides of the mitral valve annulus closer together. This approach fails to uniformly reduce the distance between the anchor points during the annulus reduction operation, resulting in tortuosity of the blood vessels on the outer wall of the heart.

[0004] Patent application CN202111003575.5 proposes an alternative repair approach. This patent discloses a clamping device, mainly comprising a base, an anchoring structure, a clamping structure connected to the base and pivotable relative to the base to form different clamping angles, and a combined structure connecting the anchoring structure and the base. The anchoring structure is used to anchor the target tissue, the clamping structure is used to clamp the target tissue anchored to the anchoring structure, and the combined structure provides axial positioning and circumferential rotation of the anchoring structure relative to the base. In this patented solution, the threaded anchoring structure is inserted into the tissue and lifted upwards, causing the driving arm to drive the clamping arm to clamp towards the center. Therefore, the clamping angle of the clamping arm depends entirely on the stroke of the threaded anchoring structure. A large stroke of the threaded anchoring structure will inevitably affect other tissues within the heart, such as the coronary arteries. Furthermore, this solution has a highly complex structure and is difficult to assemble.

[0005] In summary, existing repair devices have problems such as causing coronary artery torsion during ring reduction and the device's excessive height affecting coronary flow. Therefore, it is necessary to improve the repair devices to achieve ring reduction repair while avoiding impact on the coronary arteries and other tissues within the heart, in order to meet clinical needs. Summary of the Invention

[0006] This application is made in view of the above and other ideas.

[0007] One of the purposes of this application is to overcome the shortcomings of the prior art and provide a forming device that can locally shrink the ring, addressing issues such as coronary artery torsion caused by the shrinking of the ring in the existing forming device and the impact of excessive height of the repair device on coronary artery flow.

[0008] The technical solution adopted to solve the technical problem of the present invention is to provide a forming device for locally shrinkable annulus, including an annulus shrinkage frame, a fixing unit disposed on the annulus shrinkage frame, the fixing unit being used to insert into the annulus tissue to achieve anchoring; at least two tissue pads disposed on the annulus shrinkage frame, each tissue pad having a fixed end and a free end, the fixed end being connected to the annulus shrinkage frame, and the tissue pad being configured to have a preset bending shape, in which the free end is deflected downward relative to the fixed end; and a control wire, the control wire being detachably connected to the tissue pads, wherein the control wire controls the release of the tissue pads, and when the control wire is decoupled from the tissue pads, the tissue pads return to the preset bending shape, and the fixed ends of the tissue pads move closer to each other.

[0009] As a preferred technical solution, when the control wire is connected to the tissue patch, the tissue patch is constrained into a horizontally extending shape, and the free ends of different tissue patches are arranged opposite to each other; during implantation, the fixation unit first inserts into the valve annulus tissue to complete anchoring, and then removes the control wire, causing the control wire to separate from the tissue patch; after the tissue patch is detached from the control wire, it returns to the preset curved shape, and the free end of the tissue patch rotates downward with the fixed end as the fulcrum and compresses the valve annulus tissue, while the fixed ends of the tissue patch move closer to each other, thereby achieving local annular constriction of the valve annulus.

[0010] As a preferred technical solution, the annular frame has a quadrilateral structure, and the annular frame includes two oppositely arranged rigid rods and two oppositely arranged elastic elements; the fixed ends of the tissue tablet are respectively connected to the rigid rods; when the control wire is connected to the tissue tablet and constrains the tissue tablet to a horizontally extended shape, the elastic elements are in a stretched state; when the control wire is disconnected from the tissue tablet and the tissue tablet returns to the preset bending shape, the elastic elements retract and drive the two rigid rods to move closer to each other.

[0011] As a preferred technical solution, the fixation unit includes at least two fixation needles, which are respectively fixedly connected to the two rigid rods, and the fixation needles have sharp ends for piercing the valve annulus tissue.

[0012] As a preferred technical solution, the free end of the tissue compress is blunt-shaped to avoid the tissue compressing the valve annulus tissue and puncturing it.

[0013] As a preferred technical solution, the free end of the tissue compress is provided with a rough surface or barbs to increase the friction between the tissue and the valve annulus.

[0014] As a preferred technical solution, the fixed end of the tissue compact is provided with an arc-shaped recovery section, which has a torsion spring-like structure; the free end of the tissue compact is detachably connected to the control wire; when the control wire is connected to the free end, the tissue compact is constrained to a horizontally extended shape; when the control wire is disconnected from the free end, the arc-shaped recovery section drives the free end to rotate downward to compress the valve annulus tissue.

[0015] As a preferred technical solution, the control wire and the free end of the tissue compress are connected by a detachable collar type. The control wire passes through the annular hole provided at the free end or goes around the free end, and is disengaged from the free end by pulling the control wire.

[0016] As a preferred technical solution, the elastic element is a helical spring or an elastic fabric filament, and the two ends of the elastic element are respectively connected to the corresponding ends of the two rigid rods, and the elastic element is in an axially stretched state when the tissue tablet is constrained to a horizontal state.

[0017] As a preferred technical solution, when the elastic element is a helical spring, a fabric layer is provided around the outer periphery of the elastic element.

[0018] Compared with the prior art, the advantages of the technical solution of this application include at least the following: This invention employs at least two tissue compression patches. After the control wire is released, the free ends of the tissue compression patches press downwards against the valve annulus tissue, while the fixed ends move closer together, achieving localized annular contraction. Unlike existing technologies that directly tighten each anchor point with a pull wire (which can easily lead to tissue wrinkling and torsion of the coronary arteries and blood vessels on the outer wall of the heart), this invention utilizes the downward pressure of the tissue compression patches and the convergence of the rigid rod driven by the elastic element to distribute the annular contraction force evenly along the valve annulus, avoiding stress concentration. This reduces adverse traction on the coronary arteries and attached blood vessels on the outer wall of the heart, thereby lowering the risk of complications.

[0019] In this invention, the tissue patch extends horizontally under constraint. After release, the free end rotates downward to compress the tissue, rather than achieving ring shrinkage by upward lifting or large-angle clamping. The overall structure has a small height after implantation, avoiding the device from protruding too high from the valve annulus surface, thereby reducing interference with coronary blood flow. It is especially suitable for valve repair near the coronary artery.

[0020] The free end of the tissue compress of the present invention adopts a blunt structure to prevent puncture of the valve annulus tissue during compression; at the same time, the free end can be provided with a rough surface or barbs to increase friction and prevent instrument displacement, thus balancing safety and fixation effect.

[0021] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0022] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1 This is a schematic diagram of the annular frame of the present invention.

[0023] Figure 2 This is a schematic diagram showing the state in which the tissue tablet of the present invention remains unpressurized under the action of the control wire.

[0024] Figure 3This is a schematic diagram of the tissue compress in its natural state according to the present invention.

[0025] Figure 4 This is a schematic diagram illustrating the principle of tissue compression of the present invention acting on the heart.

[0026] Figure 5 This is a schematic diagram of the present invention when the forming device is released from the delivery system and its fixing needle is inserted into the valve annulus tissue.

[0027] Figure 6 This is a schematic diagram illustrating how the tissue tablet of the present invention rotates downwards and compresses the valve annulus tissue, while simultaneously the elastic element retracts and the rigid rods on the left and right sides move closer together.

[0028] The features represented by the numbers in the attached diagram are as follows: 1-Circular frame, 11-Rigid rod, 12-Elastic element, 2-Fixing unit, 21-Fixing needle, 211-Sharp end, 3-Tissue compression, 31-Free end, 32-Fixing end, 33-Arc-shaped return segment, 4-Control wire. Detailed Implementation

[0029] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0030] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0031] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0032] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0033] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0034] Example 1: This example uses mitral valve repair as an example. A locally shrinkable annulus forming device includes an annulus frame 1, a fixing unit 2 disposed on the annulus frame 1, the fixing unit 2 being used to insert into the valve annulus tissue for anchoring; at least two tissue compression pieces 3 disposed on the annulus frame 1, such as... Figure 1 and 2 As shown, each tissue compression piece 3 has a fixed end 32 and a free end 31. The fixed end 32 is connected to the annular frame 1, and the tissue compression piece 3 is configured to have a preset bending shape. In this preset shape, the free end 31 is deflected downward relative to the fixed end 32. A control wire 4 is detachably connected to the tissue compression piece 3, wherein the control wire 4 controls the release of the tissue compression piece 3, and when the control wire 4 is disconnected from the tissue compression piece 3, the tissue compression piece 3 returns to the preset bending shape, and the fixed ends 32 of the tissue compression pieces 3 move closer together. Figure 3 As shown.

[0035] In this embodiment, when the control wire 4 is connected to the tissue compression piece 3, the tissue compression piece 3 is constrained into a horizontally extending shape, and the free ends 31 of different tissue compression pieces 3 are arranged opposite to each other. During implantation, the fixation unit 2 first inserts into the valve annulus tissue to complete the anchoring, and then removes the control wire 4, causing the control wire 4 to separate from the tissue compression piece 3. After the tissue compression piece 3 is separated from the control wire 4, it returns to the preset curved shape. The free end 31 of the tissue compression piece 3 rotates downward with the fixed end 32 as the fulcrum and compresses the valve annulus tissue. At the same time, the fixed ends 32 of the tissue compression pieces 3 move closer to each other, thereby achieving local annular contraction of the valve annulus.

[0036] In this embodiment, the control wire 4 is a medical stainless steel wire, which has good bending stiffness and can restrain tissue compression in a horizontally extending form.

[0037] In this embodiment, the annular frame 1 has a quadrilateral structure and includes two opposing rigid rods 11 and two opposing elastic members 12. The rigid rods 11 are made of medical-grade metal materials (such as nickel-titanium alloy or stainless steel) and have sufficient bending stiffness. The fixed ends 32 of the tissue compression tablet 3 are respectively connected to the rigid rods 11. When the control wire 4 is connected to the tissue compression tablet 3 and constrains the tissue compression tablet 3 into a horizontally extended shape, the elastic member 12 is in a stretched state. When the control wire 4 is disconnected from the tissue compression tablet 3 and the tissue compression tablet 3 returns to the preset bending shape, the elastic member 12 retracts and drives the two rigid rods 11 to move closer to each other.

[0038] In this embodiment, the fixing unit 2 includes at least two fixing pins 21, which are fixedly connected to the two rigid rods 11 respectively (e.g., by welding or integral molding), and the fixing pins 21 have sharp ends 211 for piercing the valve annulus tissue.

[0039] In this embodiment, the free end 31 of the tissue compress 3 is a blunt structure to avoid the tissue compressing the annular tissue from puncturing the annular tissue.

[0040] In this embodiment, the free end 31 of the tissue compress 3 is provided with a rough surface or barbs to increase the friction between the tissue and the valve annulus.

[0041] In this embodiment, the fixed end 32 of the tissue compress 3 is provided with an arc-shaped recovery section 33, which has a torsion spring-like structure. The tissue compress 3 is made of a superelastic nickel-titanium alloy. The free end 31 of the tissue compress 3 is detachably connected to the control wire 4. When the control wire 4 is connected to the free end 31, the tissue compress 3 is constrained to a horizontally extending shape. When the control wire 4 is disconnected from the free end 31, the arc-shaped recovery section 33 drives the free end 31 to rotate downward to compress the valve annulus tissue, such as... Figure 4 As shown.

[0042] In this embodiment, the control wire 4 and the free end 31 of the tissue compress 3 are connected by a collar-type detachable connection. The control wire 4 passes through the annular hole provided in the free end 31 or goes around the free end 31. The control wire 4 is pulled to detach from the free end 31.

[0043] In this embodiment, the elastic element 12 is an elastic fabric filament, and the two ends of the elastic element 12 are respectively connected to the corresponding ends of the two rigid rods 11. The elastic element 12 is in an axially stretched state when the tissue compression tablet 3 is constrained to a horizontal state.

[0044] The process of implanting a locally shrinkable ring forming device of the present invention into the left ventricle is as follows: 1. The forming device enters the left atrium via the delivery system through the interatrial septum or apex, aligning with a local area of ​​the posterior annulus of the mitral valve; 2. The forming device is released from the delivery system, and its fixing needle 21 is inserted into the annulus tissue to achieve positioning and anchoring; 3. The control wire 4 is withdrawn, disconnecting it from the free end 31 of the tissue compression plate 3. The tissue compression plate 3 rotates downward and compresses the annulus tissue. Simultaneously, the elastic element 12 retracts, and the rigid rods 11 on both sides move closer together, as... Figure 5 and 6 As shown, the annulus is reduced in a local area (if the annulus circumference needs to be further reduced, the above operation can be repeated, and one or two shaping devices can be implanted into the annulus tissue); 4. The delivery system is removed to complete the surgery.

[0045] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A forming device capable of locally shrinking rings, characterized in that: The device includes a constriction frame, a fixing unit disposed on the constriction frame, the fixing unit being used to insert into the valve annulus tissue for anchoring, and at least two tissue pads disposed on the constriction frame, each tissue pad having a fixed end and a free end, the fixed end being connected to the constriction frame, and the tissue pad being configured to have a preset bending shape, in which the free end is deflected downward relative to the fixed end; In addition, a control wire is detachably connected to the tissue compress, wherein the control wire controls the release of the tissue compress, and when the control wire is disconnected from the tissue compress, the tissue compress returns to a preset curved shape, and the fixed ends of the tissue compresses come together.

2. The forming apparatus for locally shrinkable rings according to claim 1, characterized in that: When the control wire is connected to the tissue patch, the tissue patch is constrained into a horizontally extending shape, and the free ends of different tissue patches are arranged opposite to each other. During implantation, the fixation unit first inserts into the valve annulus tissue to complete anchoring, and then removes the control wire, causing the control wire to separate from the tissue patch. After the tissue patch is detached from the control wire, it returns to the preset curved shape. The free end of the tissue patch rotates downward with the fixed end as the fulcrum and compresses the valve annulus tissue. At the same time, the fixed ends of the tissue patch move closer to each other, thereby achieving local annular constriction of the valve annulus.

3. The forming apparatus for locally shrinkable rings according to claim 1, characterized in that: The annular frame has a quadrilateral structure and includes two opposing rigid rods and two opposing elastic elements. The fixed ends of the tissue tablet are respectively connected to the rigid rods. When the control wire is connected to the tissue tablet and constrains the tissue tablet to a horizontally extended shape, the elastic elements are in a stretched state. When the control wire is disconnected from the tissue tablet and the tissue tablet returns to the preset bending shape, the elastic elements retract and drive the two rigid rods to move closer together.

4. The forming apparatus for locally shrinkable rings according to claim 3, characterized in that: The fixation unit includes at least two fixation pins, which are respectively fixedly connected to the two rigid rods, and the fixation pins have sharp ends for piercing the valve annulus tissue.

5. The forming apparatus for locally shrinkable rings according to claim 1, characterized in that: The free end of the tissue slice is blunt to prevent the tissue slice from puncturing the valve annulus tissue when compressing it.

6. The forming apparatus for partially shrinking rings according to claim 5, characterized in that: The free end of the tissue tablet is provided with a rough surface or barbs to increase friction with the valve annulus tissue.

7. The forming apparatus for locally shrinkable rings according to claim 1, characterized in that: The fixed end of the tissue compact has an arc-shaped return section, which has a torsion spring-like structure; the free end of the tissue compact is detachably connected to the control wire; when the control wire is connected to the free end, the tissue compact is constrained into a horizontally extended shape. When the control wire is disconnected from the free end, the arc-shaped recovery segment drives the free end to rotate downward to compress the valve annulus tissue.

8. The forming apparatus for partially shrinking rings according to claim 7, characterized in that: The control wire is detachably connected to the free end of the tissue tablet via a collar. The control wire passes through a ring hole at the free end or goes around the free end, and can be detached from the free end by pulling the control wire.

9. The forming apparatus for partially shrinking rings according to claim 3, characterized in that: The elastic element is a helical spring or an elastic fabric thread. The two ends of the elastic element are respectively connected to the corresponding ends of the two rigid rods, and the elastic element is in an axially stretched state when the tissue tablet is constrained to a horizontal state.

10. A forming apparatus for partially shrinking rings according to claim 9, characterized in that: When the elastic element is a helical spring, a fabric layer is provided around the outer periphery of the elastic element.

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