Patent Description:
Tricuspid regurgitation (TR) is a common heart valve disease. In severe cases, TR can lead to decreased cardiac output and systemic congestion, and it signifies poor prognosis in many cardiac diseases and is closely related to the prognosis of patients. Surgery is currently the mainstream method to treat TR, but it has the disadvantages of using large incisions, has many complications, has high mortality, etc. Therefore, considering the limitations of surgery, it is necessary to develop a TR treatment method that uses small incisions, is simple, and has fewer complications in this technical field.

In the past <NUM> years, with the development of biomedical materials and medical imaging, breakthroughs have been made in transcatheter valve replacement and repair, making it a hot spot in interventional cardiology. At present, the most developed interventional repair technology for tricuspid valve is edge-to-edge repair, which is found in <CIT> (<CIT>). However, TR mostly originates from the central region of the three leaflets, while the edge-to-edge repair technique can only clamp the peripheral region of the leaflets, which has a limited effect, and many clips are often required to be implanted. There are also some designs targeting the central regurgitation zone of the tricuspid valve, but these designs are flawed, and thus have not really been used clinically. In addition, there are some patents relating to mitral and tricuspid valve repair devices, as disclosed in <CIT> and in <CIT>, but the prior designs and products require complex structures and components to achieve edge-to-edge repair of valves. The complex design increases the difficulty of the device fabrication process and puts forward higher requirements for the surgeon, thereby introducing more risk points. Therefore, there is an urgent need for a repair device for treatment of tricuspid regurgitation, which is simple to fabricate and operate, safe and reliable, and has an excellent therapeutic effect.

In order to overcome the deficiencies of the prior art, an objective of the present disclosure is to provide a repair device for treatment of tricuspid regurgitation that has a simple fabrication process, few implants, firm fixation, and desired effect of reducing tricuspid regurgitation (TR).

In order to achieve the above objective, the present disclosure adopts the following technical solution. A repair device for treatment of tricuspid regurgitation is delivered to leaflets of a tricuspid valve through a delivery system and includes a support frame, an occlusive membrane, and a suture line, where the support frame includes a central shaft and anchoring members that are disposed around the central shaft and radially unfolded for anchoring the leaflets of the tricuspid valve. The anchoring members include a plurality of clamp arm sets, The occlusive membrane surrounds the connections between the anchoring members and the central shaft that are on an outer side wall of the central shaft, and the occlusive membrane is connected to the support frame through the suture line. A space surrounding the central shaft is formed by the outer side wall of the central shaft, the anchoring members, and the occlusive membrane and has a ventricle-side closed end and an atrium-side open end. The central shaft has a ventricle-side closed end. The occlusive membrane is an integrally formed membrane provided between any adjacent clamp arm sets around the central shaft and including a closed bottom cover for covering the ventricle-side end of the central shaft, a waist wrapping the outer side wall of the ventricle-side end of the central shaft, and branches between adjacent clamp arm sets.

Preferably, the anchoring members each have one end fixedly connected to the central shaft and the other end radially unfolded away from the central shaft. The end of the anchoring member fixedly connected to the central shaft may be provided with a hole for threading the suture line.

Preferably, the clamp arm sets may include two clamp arms, namely, an upper clamp arm and a lower clamp arm, which may be configured to cooperate with each other to open and close. The clamp arms may be provided with barbs. An edge of the clamp arms may be provided with a hole for threading the suture line. The clamp arms may be further provided with a pull hole for threading a pull string configured to fold and unfold the clamp arms.

Preferably, the clamp arm may include a fixed connection section with a ventricle-side end fixedly connected to the central shaft and a separation section extending from the fixed connection section in an atrium-side direction. An edge of each of the fixed connection section, the separation section, and a transition section between the fixed connection section and the separation section may be provided with a hole for threading the suture line.

Preferably, the hole for threading the suture line may include a plurality of round holes or a slot hole.

Preferably, the support frame may be integrally formed by cutting a metal tube, or by heat-setting a memory metal after laser cutting or wire cutting, and has a function of shape memory. Preferably, the occlusive membrane may be made of a flexible occlusive material and may include an animal pericardial membrane, an animal valve membrane, a polyethylene terephthalate (PET) membrane, a polytetrafluoroethylene (PTFE) membrane, a polyurethane (PU) membrane, or a polyester fiber braided membrane.

Preferably, the suture line may be made of nylon or a nitinol wire.

Preferably, a transition portion may be further provided between the waist and the branches of the occlusive membrane.

Preferably, the occlusive membrane may include a plurality of membrane sheets, and the plurality of membrane sheets may be sutured to the support frame through the suture line.

Compared with the prior art, the present disclosure has the following beneficial effects:
The repair device for treatment of tricuspid regurgitation of the present disclosure includes only the occlusive membrane and the support frame, which reduces the number of implants, thereby reducing the side effects caused by implantation. Through the anchoring members, the occlusive membrane is stabilized in the center of the leaflets of the tricuspid valve to effectively reduce regurgitation in the center of the leaflets of the tricuspid valve. In addition, the occlusive membrane can be flexibly tightly sutured to the support frame to improve the occlusion effect. In addition, the repair device for treatment of tricuspid regurgitation of the present disclosure has excellent elastic properties, is convenient for contraction and retrieval, and simplifies the actual surgical operation process.

Reference Numerals: <NUM>. support frame; <NUM>. anchoring member; <NUM>. lower clamp arm; <NUM>. upper clamp arm; <NUM>. barb; <NUM>. upper hole; <NUM>. middle hole; <NUM>. lower hole; <NUM>. slot hole; <NUM>. occlusive membrane; <NUM>. bottom cover; <NUM>. waist; <NUM>. branch; <NUM>. tapered section; <NUM>. membrane sheet; <NUM>. suture line; <NUM>. central shaft; <NUM>. pull string; <NUM>. heart; <NUM>. leaflet of tricuspid valve; and <NUM>. repair device for treatment of tricuspid regurgitation.

In order to make the present disclosure more understandable, the preferred embodiments of the present disclosure are described in detail below with reference to the drawings.

As shown in <FIG>, the present disclosure provides a repair device for treatment of tricuspid regurgitation, which is delivered to leaflets <NUM> of a tricuspid valve through a delivery system and includes a support frame <NUM>, an occlusive membrane <NUM>, and a suture line <NUM>. The support frame <NUM> includes a central shaft <NUM> and anchoring members <NUM> that are disposed around the central shaft <NUM> and radially unfolded for anchoring the leaflets <NUM> of the tricuspid valve. The occlusive membrane <NUM> surrounds the connections between the anchoring members <NUM> and the central shaft <NUM> that are on an outer side wall of the central shaft <NUM>, and the occlusive membrane <NUM> is connected to the support frame <NUM> through the suture line <NUM>. A semi-closed space surrounding the central shaft <NUM> is formed by the outer side wall of the central shaft <NUM>, the anchoring members <NUM> and the occlusive membrane <NUM> and has a ventricle-side closed end and an atrium-side open end. The central shaft <NUM> has a ventricle-side closed end. The anchoring members <NUM> each have one end fixedly connected to the central shaft <NUM> and the other end radially unfolded away from the central shaft <NUM>. The end of the anchoring member <NUM> fixedly connected to the central shaft <NUM> is provided with a hole for threading the suture line. The anchoring members <NUM> include a plurality of clamp arm sets. Each clamp arm set includes two clamp arms, namely an upper clamp arm <NUM> and a lower clamp arm <NUM>, which are configured to cooperate with each other to open and close. The upper clamp arm is provided with barbs <NUM>. The occlusive membrane <NUM> is provided between any adjacent clamp arm sets around the central shaft <NUM>. An edge of the clamp arms is provided with a hole for threading the suture line <NUM>. The clamp arms are further provided with a pull hole for threading a pull string <NUM> configured to fold and unfold the clamp arms. The clamp arms include a fixed connection section with a ventricle-side end fixedly connected to the central shaft <NUM> and a separation section extending from the fixed connection section in an atrium-side direction. An edge of each of the fixed connection section, the separation section, and a transition section between the fixed connection section and the separation section is provided with a hole for threading the suture line <NUM>. The hole for threading the suture line <NUM> includes a plurality of round holes or a slot hole <NUM>. The support frame <NUM> is integrally formed by cutting a metal tube, or by heat-setting a memory metal after laser cutting or wire cutting, and has a function of shape memory. The occlusive membrane <NUM> is made of a flexible occlusive material and includes an animal pericardial membrane, an animal valve membrane, a polyethylene terephthalate (PET) membrane, a polytetrafluoroethylene (PTFE) membrane, a polyurethane (PU) membrane, or a polyester fiber braided membrane, etc. The suture line <NUM> is made of nylon or a nitinol wire, etc. The occlusive membrane <NUM> is an integrally formed membrane. It includes a closed bottom cover <NUM> for covering the ventricle-side end of the central shaft <NUM>, a waist <NUM> wrapping the outer side wall of the ventricle-side end of the central shaft <NUM>, and branches <NUM> between adjacent clamp arm sets. Alternatively, a transition portion is further provided between the waist <NUM> and the branches <NUM>. The occlusive membrane <NUM> includes a plurality of membrane sheets, and the plurality of membrane sheets are sutured to the support frame <NUM> through the suture line <NUM>.

As shown in <FIG>, the present disclosure provides a repair device for treatment of tricuspid regurgitation <NUM>, which includes a support frame <NUM>, an occlusive membrane <NUM>, and a suture line <NUM> connecting the support frame and the occlusive membrane. The support frame <NUM> is integrally cut and shaped by a metal tube. The occlusive membrane <NUM> is made of a flexible occlusive material and may be an animal pericardial membrane, an animal valve membrane, a PET membrane, a PTFE membrane, a PU membrane, a polyester fiber membrane, or other braided membrane. The gaps at the center and the roots of the branches of the support frame <NUM> are completely covered by the occlusive membrane <NUM>. After the branches of the support frame <NUM> are grasped and fixed to the tricuspid valve, the occlusive membrane <NUM> is located at a central position surrounded by the leaflets of the tricuspid valve to fill the space to achieve the purpose of occlusion. The occlusive membrane <NUM> is fixed through round holes (including an upper hole <NUM>, a lower hole <NUM>, and a middle hole <NUM>, as shown in <FIG>) or a slot hole (a slot hole <NUM>, as shown in <FIG>) at a bent edge of the anchoring member <NUM> on the support frame <NUM>. The occlusive membrane <NUM> can completely cover the center of the support frame <NUM> and the root of the anchoring member <NUM> to repair the defective tricuspid valve. The occlusive membrane <NUM> is fixed to the support frame <NUM> by suturing. The suture line <NUM> may be made of nylon, a braided thread, or a nitinol wire. The occlusive membrane <NUM> can be formed by cutting and suturing a whole membrane sheet or a plurality of membrane sheets. The occlusive membrane <NUM> is sleeved onto a lower part of the support frame <NUM> and is sutured to the hole on the support frame <NUM> through the suture line <NUM> to achieve the purpose of occlusion. The support frame <NUM> includes <NUM> to <NUM> anchoring members <NUM>. The upper and lower clamp arms of the anchoring member <NUM> are cut from the same metal tube. The anchoring members <NUM> are radially unfolded, and an unfolding angle between the anchoring members <NUM> can be adjusted to <NUM>°, <NUM>°, <NUM>° and others according to time use situation. The upper clamp arm <NUM> and the lower clamp arm <NUM> of the anchoring member <NUM> are shaped to intersect each other by heat setting to secure the valve. The upper clamp arm <NUM> and the lower clamp arm <NUM> are provided with wire pull holes. A pull string <NUM> is threaded through the pull hole to fold and unfold the clamp arm, thereby grasping and fixing the tricuspid valve.

In order to overcome the deficiencies of the prior art, the present disclosure provides a repair device for treatment of tricuspid regurgitation, which can effectively reduce TR. Herein, "upper end" refers to an end of the implant, namely the repair device for treatment of tricuspid regurgitation facing an atrium, and "lower end" refers to an end of the repair device for treatment of tricuspid regurgitation facing a ventricle.

The repair device for treatment of tricuspid regurgitation <NUM> includes a support frame <NUM>, an occlusive membrane <NUM>, a central shaft <NUM>, a suture line <NUM>, and a pull string <NUM>. The support frame <NUM> is integrally cut and shaped by a metal tube. The occlusive membrane <NUM> is made of a flexible occlusive material and may be an animal pericardial membrane, an animal valve membrane, a PET membrane, a PTFE membrane, a PU membrane, a polyester fiber membrane, or other braided membrane. The pull string <NUM> has one end fixed to the clamp arms of an anchoring member <NUM> and the other end threaded through the hole in the central shaft <NUM> and controlled by a member through a delivery system. The clamp arms grasp and anchor the tricuspid valve by retracting and releasing the pull string <NUM>. The gaps at the center and the roots of the branches of the support frame <NUM> are completely covered by the occlusive membrane <NUM>. After the branches of the support frame <NUM> are grasped and fixed to the tricuspid valve, the occlusive membrane <NUM> is located at a central position surrounded by the leaflets of the tricuspid valve to fill the space to achieve the purpose of occlusion.

As shown in <FIG>, the repair device includes the support frame <NUM> and the occlusive membrane <NUM>. The support frame <NUM> includes anchoring members <NUM>, an upper hole <NUM>, a middle hole <NUM>, and a lower hole <NUM>. The support frame <NUM> is integrally cut from a nitinol tube. The anchoring member <NUM> is composed of an upper clamp arm <NUM> and a lower clamp arm <NUM>. The support frame is provided with three anchoring members <NUM>, and the anchoring members <NUM> are evenly distributed. The central shaft <NUM> is located inside the support frame <NUM> and is provided with a hole for threading the pull string <NUM>. One end of the pull string <NUM> is fixed to the clamp arms of the anchoring member <NUM>. In actual operation, the upper and lower clamp arms are pulled by the pull string <NUM> to grasp the leaflets. In a natural state, the upper and lower clamp arms are fixed to the tricuspid valve to achieve the purpose of repair. The occlusive membrane <NUM> may be an animal pericardial membrane, an animal valve membrane, a PET membrane, a PTFE membrane, a PU membrane, a polyester fiber membrane, or other braided membrane. The occlusive membrane is fixed to the support frame <NUM> through the upper hole <NUM>, the middle hole <NUM>, and the lower hole <NUM>. Within the coverage of the occlusive membrane <NUM>, the regurgitation in the gap among the leaflets <NUM> of the tricuspid valve can be prevented.

<FIG> shows a structure of an occlusive membrane. In this structure, the occlusive membrane <NUM> is composed of a bottom cover <NUM>, a waist <NUM>, and branches <NUM>. There are three branches <NUM>, the size of which is determined according to the gap of the anchoring members <NUM> of the support frame <NUM>. Optionally, the bottom cover <NUM>, the waist <NUM> and the branches <NUM> may be cut out of the same material. In this way, the assembly of the occlusive membrane is simplified, and the overall occlusion performance is improved. In other embodiments, the bottom cover <NUM> and the waist <NUM> may be made of a material with higher strength and better fit performance (such as a metal woven mesh or PTFE). The branches <NUM> can be made of a biological material with better occlusion performance or a polymer material such as PET. Then the two different materials are assembled into a desired shape by stitching.

<FIG> shows a suture connection between the occlusive membrane <NUM> and the support frame <NUM> shown in <FIG>. The occlusive membrane <NUM> is sleeved onto the lower end of the support frame <NUM> to completely cover the central part of the support frame <NUM>. The edge of the occlusive membrane <NUM> is sutured to the support frame <NUM> by the suture line <NUM>. The suture line <NUM> is threaded through the upper hole <NUM>, the middle hole <NUM>, and the lower hole <NUM> of the support frame <NUM> to suture the edge of the occlusive membrane <NUM>. The size of the occlusive membrane <NUM> is adjustable according to the support frame <NUM> to make it completely fit with the support frame to improve the occlusion effect.

<FIG> shows another optional occlusive membrane structure. A branch <NUM> has an upper end in the shape of an inverted triangle and a lower end provided with a rectangular protruding section. In actual assembly, the three branches <NUM> are assembled together. The occlusive membrane structure reduces the splicing between different membrane sheets and can be sutured to the support frame <NUM>. This design reduces damage to the occlusive membrane and simplifies the fabrication process.

<FIG> shows the suture connection between the branch <NUM> shown in <FIG> and the support frame <NUM>. In this design, the central part of the support frame <NUM> may be blocked mechanically or by other means. The branches <NUM> mainly cover the gaps between adjacent anchoring members <NUM>. The edge of the occlusive membrane <NUM> is sutured to the support frame <NUM> by the suture line <NUM>. Specifically, the suture line <NUM> is threaded through the upper hole <NUM>, the middle hole <NUM>, and the lower hole <NUM> of the support frame <NUM> and is sutured to the edges of the two sides of the inverted triangle of the occlusive membrane.

<FIG> shows another optional occlusive membrane structure. In this structure, a tapered section <NUM> is added on the basis of the occlusive membrane structure shown in <FIG>. This tapered section matches the arc of the root of the anchoring member <NUM> of the support frame <NUM>. When the occlusive membrane <NUM> and the support frame <NUM> are sutured, the tapered section <NUM> can fit with the support frame to improve the occlusion effect.

<FIG> shows the support frame <NUM> with the slot hole <NUM>. During assembly, the slot hole <NUM> for assembling the occlusive membrane <NUM> reduces the restriction on the number of stitches of the suture line <NUM>. Tighter stitches can be used to assemble the occlusive membrane <NUM> and the support frame <NUM> together.

<FIG> shows a first configuration of the repair device for treatment of tricuspid regurgitation <NUM> of the present disclosure during delivery, and <FIG> shows a second configuration of the repair device for treatment of tricuspid regurgitation that is naturally unfolded after being released from the delivery system. In the first configuration, the repair device for treatment of tricuspid regurgitation <NUM> is compressed into a strip and inserted into a delivery sheath. The flexible occlusive membrane <NUM> is foldable, and the upper clamp arm <NUM> and the lower clamp arm <NUM> are folded toward the central shaft <NUM> to be received into the delivery system. In the second configuration, the repair device for treatment of tricuspid regurgitation <NUM> is released from the delivery system and unfolded naturally. In this configuration, the three pairs of upper and lower clamp arms are radially unfolded at the outer periphery of the central shaft <NUM>, and the occlusive membrane <NUM> fills the gaps between adjacent pairs of upper and lower clamp arms.

<FIG> shows step-by-step clamping and fixation of the repair device for treatment of tricuspid regurgitation <NUM> during implantation. First, the repair device for treatment of tricuspid regurgitation is delivered to an intended location (a right ventricle) by the delivery system. One of the lower clamp arms <NUM> is released by a drive member of the delivery system. Then, the position of the repair device for treatment of tricuspid regurgitation in a heart <NUM> is adjusted by a control member of the delivery system, such that a target leaflet of the tricuspid valve is placed on the lower clamp arm <NUM>. The upper clamp arm <NUM> is released to a natural state, and the barbs <NUM> on the unfolded upper clamp arm <NUM> hook the leaflet of the tricuspid valve to prevent it from slipping out between the upper and lower clamp arms (<FIG>). Since the upper and lower clamp arms are integrally connected and shaped, the upper and lower clamp arms in the natural state clamp the corresponding leaflet of the tricuspid valve. In this way, the repair device for treatment of tricuspid regurgitation can be effectively anchored in the center of the leaflets of the tricuspid valve even when the heart is beating, as shown in <FIG>.

The repair device for treatment of tricuspid regurgitation <NUM> can be implanted at the center of the leaflets <NUM> of the tricuspid valve in the right ventricle through the delivery system in a transthoracic or transfemoral manner (<FIG>, delivery system not shown). In this embodiment, the occlusive membrane <NUM> may use a material and structure with desired biocompatibility and be able to promote endothelialization to accelerate the endothelialization of the leaflet and the repair device after operation and improve the safety of the device.

Claim 1:
A repair device for treatment of tricuspid regurgitation (<NUM>), configured to be delivered to leaflets of a tricuspid valve through a delivery system, comprising a support frame (<NUM>), an occlusive membrane (<NUM>), and a suture line (<NUM>), wherein the support frame (<NUM>) comprises a central shaft (<NUM>) and anchoring members (<NUM>), including a plurality of clamp arm sets, that are disposed around the central shaft (<NUM>) and radially unfolded for anchoring the leaflets of the tricuspid valve; the occlusive membrane (<NUM>) surrounds connections between the anchoring members (<NUM>) and the central shaft (<NUM>) that are on an outer side wall of the central shaft (<NUM>), and the occlusive membrane (<NUM>) is connected to the support frame (<NUM>) through the suture line (<NUM>); a space surrounding the central shaft (<NUM>) is formed by the outer side wall of the central shaft (<NUM>), the anchoring members (<NUM>) and the occlusive membrane (<NUM>), and has a ventricle-side closed end and an atrium-side open end; and the central shaft (<NUM>) has a ventricle-side closed end;
the repair device being characterized in that the occlusive membrane is an integrally formed membrane provided between any adjacent clamp arm sets around the central shaft and including a closed bottom cover for covering the ventricle-side end of the central shaft, a waist wrapping the outer side wall of the ventricle-side end of the central shaft, and branches between adjacent clamp arm sets.