A prosthetic valve unit, a prosthetic valve and a valve device

Abstract

The present application relates to a kind of artificial valve units, including skirt unit and valve leaflet unit, the upper end of the skirt unit has the notch that is concave downward, the lower end of the valve leaflet unit has the extension corresponding with the notch and protruding downward, the edge of the notch is sutured with the edge of the extension, the two sides of the valve leaflet unit have pull part, the lower end edge of the pull part is connected with the edge of the extension to form pull point, the pull point is sutured to the upper end of the notch, the lower end edge of the pull part extends to the direction away from the middle of the valve leaflet unit, it realizes the widening design of pull point, increases the tensile property of valve leaflet unit, makes the force point when valve leaflet works scattered to each side of pull part, strengthens its fatigue resistance, the present application also provides an artificial valve and valve device.

Description

Technical Field

[0001] This invention relates to the field of percutaneous interventional surgical equipment technology, specifically to an artificial valve unit, an artificial valve, and a valve device. Background Technology

[0002] Heart valve replacement surgery has become a routine surgical option for patients with valvular insufficiency or calcified stenosis. The current treatment method is still surgical. Although some procedures can be performed using minimally invasive techniques (i.e., the so-called "keyhole" technique), the vast majority of valve replacement surgeries still require open-heart surgery to perform cardiopulmonary bypass and stop the heartbeat. Although this open-heart surgery method is a mature surgical method, it causes great trauma to patients, requires a lot of recovery time, and can cause many life-threatening complications during the process.

[0003] Percutaneous interventional therapy has gained increasing attention due to its minimal invasiveness and minimal damage. Through persistent efforts, several problems encountered during percutaneous artificial heart valve repair have now been resolved. The specific procedure is as follows: First, the artificial heart valve prosthesis is compressed and placed into a delivery sheath. Then, an opening is made in the femoral artery, and the delivery sheath is advanced through this opening and into the desired valve location via the body's blood vessels. Finally, it is released.

[0004] The shape and structure of artificial heart valves are often determined by the biological shape and size of the valve being repaired (i.e., mitral, tricuspid, aortic, or pulmonary valve). Generally, prosthetic heart valves are designed to function like the original valve, and therefore include leaflet structures. In existing technologies, during continuous opening and closing, the connection point between the leaflet and the skirt is subjected to continuous tension or compression. To prevent structural damage, artificial valves require very high connection strength at this point. Due to structural design flaws, existing artificial valves have poor leaflet tensile and fatigue resistance, and valve devices incorporating artificial valves also suffer from poor tensile and fatigue resistance. Summary of the Invention

[0005] Based on the above description, the present invention provides an artificial valve unit, which solves the technical problem of poor tensile and fatigue performance of valve devices through the unique structure and connection design of the leaflet and skirt, as well as the design of the reinforcement.

[0006] The technical solution of the present invention to solve the above-mentioned technical problems is as follows:

[0007] An artificial valve unit includes a skirt unit and a leaflet unit. The upper end of the skirt unit has a downwardly recessed notch, and the lower end of the leaflet unit has an extension that corresponds to the notch and protrudes downward. The edge of the notch is sewn to the edge of the extension. The leaflet unit has lifting portions on both sides. The lower edge of the lifting portion is connected to the edge of the extension to form a lifting point. The lifting point is sewn to the upper end of the notch, and the lower edge of the lifting portion extends away from the center of the leaflet unit.

[0008] Compared with the prior art, the technical solution of this application has the following beneficial technical effects:

[0009] This application achieves a widened lifting point design by connecting the lower edge of the lifting portion with the edge of the extension portion to form a lifting point, and extending the lower edge of the lifting portion away from the center of the leaflet unit. This increases the tensile strength of the leaflet unit, distributes the force points of the leaflet during operation to each side of the lifting portion, and enhances its fatigue resistance.

[0010] Based on the above technical solution, the present invention can be further improved as follows.

[0011] Furthermore, the edge of the notch and the edge of the extension partially overlap, and the overlap width is no more than 1mm. The stitching method is an interlocking knot stitching method, and the stitch distance ranges from 0.7 to 1mm.

[0012] Furthermore, the upper end of the leaflet unit is a smooth, downward-concave curve, and the lower end of the skirt unit is serrated along the width direction.

[0013] The present invention also provides an artificial valve comprising at least three artificial valve units as described above, all of which are sequentially connected in a ring shape, wherein the outer edges of two adjacent skirt units are sutured together, and the lifting portions of two adjacent leaflet units are sutured together.

[0014] The beneficial effects of adopting the above-mentioned technical method are as follows:

[0015] Through the structural design and optimization of the above-mentioned artificial valve unit structure and connection method, the artificial valve composed of it has better tensile strength and fatigue resistance, and its service life is significantly improved.

[0016] Furthermore, the outer edges of two adjacent skirt units overlap, with an overlap width of no more than 1 mm. The stitching method is an interlocking knot stitch, with a stitch length range of 0.7-1 mm.

[0017] Based on the above, the present invention also provides a valve device, including a self-expanding stent and an artificial valve as described above. The self-expanding stent includes a stent body and several positioning members. The stent body has a through hole defined inside. The skirt unit forms an annular connection to the sidewall of the through hole. The positioning member has a root and a bottom. The root of the positioning member is connected to one end of the stent body. The bottom of the positioning member can be positioned and connected to the heart tissue. The sidewall of the stent body connected to the end of the positioning member is formed by multiple end grids. Two lifting parts of adjacent leaflet units respectively wrap around the two sides of the end grids and are sutured and fixed. A reinforcing member is provided on the root of the positioning member. One end of the reinforcing member is connected to the stent body or the valve prosthesis, and the other end is connected to the positioning member to prevent the positioning member from separating from the stent body.

[0018] After the artificial valve is sutured together with the leaflet unit and the skirt unit, it is then sutured and fixed to the stent body. This disperses the force when the leaflet opens and closes periodically, making the structure more stable. Secondly, by setting the reinforcement at the root of the positioning component, the connection between the root of the positioning component and the stent body can be effectively strengthened, preventing the positioning component from separating from the stent body and preventing the positioning component from falling off and causing further damage to the patient's body.

[0019] Furthermore, when the positioning member has two roots and forms a closed loop with the main body support, both roots of the positioning member are provided with reinforcement members, the bottom of the positioning member is located between the two roots, and when the bottom of the positioning member clamps or anchors the heart tissue, the bottom of the positioning member is connected with a buffer.

[0020] Furthermore, when the positioning element has a root, the positioning element forms an open loop with the stent body, the bottom of the positioning element and the root of the positioning element constitute the two ends of the positioning element, and the bottom of the positioning element is connected to a buffer when clamping or anchoring cardiac tissue.

[0021] Furthermore, both the reinforcing member and the buffer member are made of polyester fabric or ox heart bag, and their connection method is sewing. The sewing method is interlocking knot sewing, and the stitch distance ranges from 0.7 to 1 mm.

[0022] Furthermore, the suture trajectory of the artificial valve and the stent body coincides with the suture trajectory of the skirt unit and the leaflet unit, and they are sutured in a staggered manner; the suture points of two adjacent skirt units are located on the above-mentioned suture trajectory and are sutured in a staggered manner. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the structure of a valve device provided in an embodiment of the present invention;

[0024] Figure 2 This is a schematic diagram of the disassembled structure of an artificial valve unit;

[0025] Figure 3 This is a schematic diagram of the structure of an artificial valve;

[0026] Figure 4 This is a schematic diagram of the structure of a self-expanding stent;

[0027] Figure 5 This is a three-dimensional structural diagram of one embodiment of this application;

[0028] Figure 6 for Figure 5 A top-view structural diagram. Detailed Implementation

[0029] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate embodiments of the present application. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the disclosure of this application will be thorough and complete.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0031] It is understood that spatial relation terms such as "below," "under," "below," "below," "above," "over," etc., can be used here to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figure is flipped, the element or feature described as "below" or "under" or "below" of other elements or features will be oriented "over" of other elements or features. Therefore, the exemplary terms "below" and "under" can include both upper and lower orientations. Furthermore, the device may also include other orientations (e.g., rotated 90 degrees or other orientations), and the spatial descriptive terms used herein will be interpreted accordingly.

[0032] It should be noted that when one element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediary element. In the following embodiments, "connection" should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have the transmission of electrical signals or data between them.

[0033] When used herein, the singular forms of “a,” “an,” and “the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising,” “including,” or “having,” etc., specify the presence of the stated feature, whole, step, operation, component, part, or combination thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof.

[0034] like Figure 1 and combined Figure 5 and Figure 6 As shown, the application provides a valve device that is primarily designed to meet the needs of patients with regurgitation, while also taking into account aortic stenosis cases, and has the function of actively capturing aortic valve leaflets.

[0035] It includes a self-expanding stent 10 and an artificial valve 20.

[0036] like Figure 4 The self-expanding support 10 shown is one embodiment of the support. The self-expanding support 10 includes a support body 11 and a plurality of positioning elements 12. The support body 11 has a through hole 11a defined inside. According to the liquid flow direction inside the through hole 11a, the two ends of the through hole 11a are generally named the inflow end and the outflow end, respectively.

[0037] The positioning member 12 has a root 121 and a bottom 122. The root 121 of the positioning member 12 is connected to one end of the stent body 11. In some embodiments, the root 121 of the positioning member 12 is connected to the inflow end of the stent body 11. In other embodiments, the root 121 of the positioning member 12 is connected to the outflow end of the stent body 11. In this embodiment, the latter connection method is preferred, that is, the root 121 of the positioning member 12 is connected to the outflow end of the stent body 11. The bottom 122 of the positioning member 12 can be positioned and connected to the heart tissue. The bottom 122 of the positioning member 12 can be connected to the heart tissue by clamping, anchoring or inserting. The sidewall of the outflow end is formed by multiple end grids.

[0038] The structure of the stent body 11 and the positioning element 12 constitutes the basic support frame of the valve device.

[0039] The artificial valve 20 includes at least three artificial valve units 21. In this embodiment, the artificial valve 20 includes three artificial valve units 21. It is understood that in other embodiments, the artificial valve 20 may include more than three artificial valve units 21.

[0040] The artificial valve unit 21 includes a skirt unit 211 and a leaflet unit 212. The upper end of the skirt unit 211 has a downwardly recessed notch 211a, and the lower end of the leaflet unit 212 has an extension 2121 that corresponds to the notch 21a and protrudes downward. The edge of the notch 211a is sewn to the edge of the extension 2121. The inward concavity of the skirt unit 211 and the outward convexity of the leaflet unit 212 are matched and have a smooth arc design for easy sewing. The leaflet unit 212 has lifting portions 2122 on both sides. The lower edge of the lifting portion 2122 is connected to the edge of the extension 2121 to form a lifting point T. The lifting point T is sewn to the upper end of the notch 211a, and the lower edge of the lifting portion 2122 extends away from the middle of the leaflet unit 212.

[0041] The artificial valve unit 21 of this structural design realizes the widening design of the lifting point T, which increases the tensile strength of the leaflet unit 212 and distributes the force point of the leaflet during operation to each side of the lifting part 2122, thereby enhancing its fatigue resistance.

[0042] In this embodiment, the preferred stitching method for the skirt unit 211 and the leaflet unit 212 is as follows:

[0043] The edge of the notch 211a and the edge of the extension 2121 partially overlap, and the overlap width is no more than 1 mm. The stitching method is a ring-to-ring knot stitching method, and the stitch distance is controlled within the range of 0.7-1 mm. There are two ways to overlap the edges: overlapping the edges in successive layers and overlapping the two edges after folding and butting them together. In actual use, both overlapping methods can be selected according to actual needs. In this embodiment, the latter method, i.e., overlapping after butting, is preferred. The overlapping in the stitching methods mentioned later in this embodiment also adopts overlapping after butting.

[0044] The upper end of the leaflet unit 212 is a smooth curve that is concave downwards. After all three leaflet units 212 are fixedly installed, when the three leaflets open and close periodically, the movement trajectory of each leaflet does not overlap. That is, when closed, the three leaflets will not overlap, so they will not affect each other.

[0045] In actual use, the greater the thickness of the compression loading, the larger the size requirement of the sheath, and the less safe it is for human blood vessels. In this example, the lower end of the skirt unit 211 is designed as a serrated shape along the width direction, which can fit well with the diamond-shaped edge of the bottom of the stent body 11. When it is compressed and loaded into the sheath, the thickness of the compression loading can be reduced, making loading easier.

[0046] Three pre-connected artificial valve units 21 are connected into a ring, wherein the outer edges of two adjacent skirt units 211 are sutured together, and the lifting portions of two adjacent leaflet units 212 are sutured together.

[0047] Correspondingly, the outer edges of two adjacent skirt units 211 overlap, and the overlap width is no more than 1mm. The stitching method is interlocking knot stitching, and the stitch distance ranges from 0.7 to 1mm.

[0048] This constitutes the artificial valve structure of the valve device. Then, connecting the artificial valve structure with the basic support frame forms the valve device.

[0049] The skirt unit 211 forms an annular connection to the side wall of the through hole 11a, and the two lifting parts 2122 of the adjacent leaf unit 212 respectively wrap around the two sides of the end mesh and are sewn and fixed.

[0050] In the embodiments of this application, since the positioning member 12 can be connected to the heart tissue by clamping, anchoring or piercing, the positioning member 12 will inevitably be subjected to a large force, and the root of the positioning member 12 is the most vulnerable to breakage. The root of the positioning member 12, where it is connected to the stent body 11, has poor tensile strength and poor fatigue performance. Therefore, in order to enhance the connection stability between the positioning member 12 and the stent body 11, a reinforcing member 13 is provided on the root 121 of the positioning member 12. In some embodiments, the two ends of the reinforcing member 13 are respectively connected to the stent body 11 and the positioning member 12. In other embodiments, the two ends of the reinforcement 13 can also be connected to the artificial valve 20 and the positioning member 12 respectively. In the first connection method, the reinforcement 13 is an independent small component, which is the preferred solution. In another connection method, the reinforcement 13 can be a component extending from the leaflet or skirt. When the reinforcement 13 is a component extending from the leaflet or skirt, it can be understood that the reinforcement 13 and the leaflet or skirt are made of the same material, and the reinforcement 13 is connected to the leaflet or skirt by stitching. Alternatively, the reinforcement 13 can also extend directly from the leaflet or skirt, which can be understood as the reinforcement 13 being a part of the leaflet or skirt.

[0051] The design of the reinforcement member 13, depending on the specific structure of the positioning member 12, generally includes the following methods:

[0052] In the preferred embodiment of this application, such as Figure 5As shown, when the positioning member 12 has two roots 121 and forms a closed loop with the main body support 11, the bottom 122 of the positioning member 12 is located between the two roots 121. When the roots of the positioning member 12 are located at the outflow end of the support body 11, the positioning member 12 extends a short distance towards the outflow end and then folds back towards the inflow end. The positioning member 12 can be used to clamp or anchor the leaflets in the heart. In other embodiments, when the roots of the positioning member 12 are located at the outflow end of the support body 11, the bottom of the positioning member 12 directly points towards the inflow end. Positioning member 12 can be used to clamp or anchor the leaflets in the heart. Alternatively, when the root of positioning member 12 is located at the inflow end of stent body 11, the bottom of positioning member 12 can extend towards the inflow end or towards the outflow end. Positioning member 12 can be used to clamp or anchor the leaflets in the heart, or it can be inserted into the inner wall of the heart. In more embodiments, multiple positioning members 12 can be circumferentially connected into a ring and then connected to stent body 11, or they can be directly distributed at intervals around stent body 11. Positioning member 12 can be used to clamp or anchor the leaflets in the heart.

[0053] In the above embodiments, both roots 121 of the positioning member 12 are provided with reinforcement members 13. More preferably, the bottom 122 of the positioning member 12 is connected to a buffer member 14. During the release of the stent body 11, when the positioning member 12 clamps or anchors the heart valve leaflet, its bottom 122 is prone to damage to the heart tissue. Therefore, the buffer member 14 can effectively protect the heart tissue.

[0054] The reinforcement 13 and the buffer 14 are made of polyester fabric or ox heart, and are connected by sewing. The sewing method is a loop-to-loop knot sewing method with a stitch length range of 0.7-1mm.

[0055] In another embodiment of this application, when the positioning member 12 has a root 121, the bottom 122 and the root 121 of the positioning member 12 constitute the two ends of the positioning member 12. The positioning member 12 and the stent body 11 form an open loop. In this structure, when the bottom of the positioning member 12 is used to insert into the inner wall of the heart, the bottom 122 of the positioning member 12 may not be provided with a buffer 14. When the bottom 122 of the positioning member 12 is used to clamp or anchor the heart valve leaflets, the bottom 122 of the positioning member 12 may be provided with a buffer 14. This is also to prevent the bottom 122 of the positioning member 12 from scratching the heart tissue when clamping or anchoring the heart tissue in the open loop state.

[0056] The reinforcement component 13 is still made of polyester fabric or ox heart bag, and its connection method is sewing fixation. The sewing method is interlocking dead knot sewing, and the stitch distance ranges from 0.7 to 1 mm.

[0057] In addition to the above structure, regardless of whether the reinforcement 13 and the support body 11 are open-loop or closed-loop, when the reinforcement 13 is an independent small component, the reinforcement 13 can also be a reinforcing wire, such as a nickel-titanium wire structure, or a cloth-like or strip-like component connected by winding or binding.

[0058] The aforementioned heart valve leaflets are not limited to the mitral, tricuspid, aortic, or pulmonary valves, such as... Figure 4 , Figure 5 , Figure 6 As one embodiment applicable to the aortic valve, the above-mentioned scheme mentions that the root of the positioning element 12 is located at different positions on the stent body 11, the bottom orientation of the positioning element 12 is different, and the open-loop and closed-loop states of the positioning element 12 are different. It can be applied to the mitral valve, tricuspid valve and pulmonary valve. That is to say, the positioning element 12 is located on the stent body 11, and the positioning element 12 is used to clamp, anchor or insert into the heart tissue. It will be subjected to a large force, thus having the risk of breakage. The reinforcement element 13 can all achieve the function of preventing the positioning element 12 from detaching.

[0059] In a preferred embodiment of this application, the suture trajectory of the artificial valve 20 and the stent body 11 coincides with the suture trajectory of the skirt unit 211 and the leaflet unit 212, and they are sutured in a staggered manner. More preferably, the suture points of two adjacent skirt units 211 are located on the above-mentioned suture trajectory and are sutured in a staggered manner.

[0060] That is, the suture trajectory of the skirt unit 211 and the leaflet unit 212 after suturing is still on the same suture trajectory when the artificial valve 20 is sutured to the stent body 11, and the suture is staggered so as not to occupy other positions of the skirt unit 211 and the leaflet unit 212, so as to prevent the suture lines from being messy and causing leakage.

[0061] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A valve device, characterized in that, Including self-expanding stents and artificial valves; The artificial valve includes at least three artificial valve units. Each artificial valve unit includes a skirt unit and a leaflet unit. The upper end of the skirt unit has a downwardly recessed notch, and the lower end of the leaflet unit has an extension that corresponds to the notch and protrudes downward. The edge of the notch is sewn to the edge of the extension. The leaflet unit has lifting portions on both sides. The lower edge of the lifting portion is connected to the edge of the extension to form a lifting point. The lifting point is sewn to the upper end of the notch. The lower edge of the lifting portion extends away from the center of the leaflet unit. All the artificial valve units are connected in sequence to form a ring. The outer edges of two adjacent skirt units are sewn together, and the lifting portions of two adjacent leaflet units are sewn together. The self-expanding stent includes a stent body and several positioning elements. The stent body has an internal through hole, and a skirt unit is connected in a ring to the side wall of the through hole. The positioning element has a root and a bottom. The root of the positioning element is connected to one end of the stent body, and the bottom of the positioning element can be positioned and connected to the heart tissue. The side wall of the stent body connected to the end of the positioning element is formed by multiple end grids. Two lifting parts of the adjacent leaflet unit respectively wrap around the two sides of the end grids and are sutured and fixed. A reinforcement is provided on the root of the positioning element. One end of the reinforcement is connected to the stent body or the valve prosthesis, and the other end is connected to the positioning element to prevent the positioning element from separating from the stent body. When the positioning element is clamped or anchored to cardiac tissue, a buffer is connected to the bottom of the positioning element.

2. The valve device according to claim 1, characterized in that, The edge of the notch and the edge of the extension partially overlap, and the overlap width is no more than 1mm. The stitching method is the interlocking knot stitching method, and the stitch distance ranges from 0.7 to 1mm.

3. The valve device according to claim 1, characterized in that, The upper end of the leaflet unit is a smooth, downward-concave curve, and the lower end of the skirt unit is serrated along the width direction.

4. The artificial valve according to claim 1, characterized in that, The outer edges of two adjacent skirt units overlap, with an overlap width of no more than 1 mm. The stitching method is a loop-to-loop knot stitching method, with a stitch length range of 0.7-1 mm.

5. The valve device according to claim 1, characterized in that, When the positioning element has two roots and forms a closed loop with the main body support, both roots of the positioning element are provided with reinforcements, the bottom of the positioning element is located between the two roots, and the bottom of the positioning element is connected to a buffer when clamping or anchoring heart tissue.

6. The valve device according to claim 1, characterized in that, When the positioning element has a root, the positioning element forms an open loop with the stent body. The bottom of the positioning element and the root of the positioning element constitute the two ends of the positioning element. When the bottom of the positioning element clamps or anchors the heart tissue, a buffer element is connected to the bottom of the positioning element.

7. The valve device according to claim 6, characterized in that, Both the reinforcing member and the buffer member are made of polyester fabric or ox heart bag, and they are connected by sewing. The sewing method is a loop-to-loop knot sewing method with a stitch length range of 0.7-1mm.

8. The valve device according to claim 6, characterized in that, The suture trajectory of the artificial valve and the stent body coincides with the suture trajectory of the skirt unit and the leaflet unit, and they are sutured in a staggered manner; the suture points of two adjacent skirt units are located on the above suture trajectory and are sutured in a staggered manner.

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