Disclosure of Invention
The present invention aims to solve at least one of the technical problems existing in the prior art. Therefore, an object of the present invention is to provide a self-stabilized tricuspid valve support, which can be stably supported on the diaphragm of the tricuspid valve of a human body, and has a service life that can meet practical requirements, and a diaphragm is arranged on the inner periphery of the annular column structure of the self-stabilized tricuspid valve support to form a prosthetic valve, so that the function of the tricuspid valve of the human body can be stably exerted instead of the tricuspid valve of the human body.
A self-stabilizing tricuspid stent according to an embodiment of the present invention, comprising:
The annular column structure comprises a plurality of V-shaped frame members positioned on one side and a plurality of U-shaped frame members positioned on the other side, wherein the V-shaped frame members and the U-shaped frame members are sequentially and alternately staggered and connected along a circular arrangement to form the annular column structure with wavy characteristics, and the closed ends of the V-shaped frame members and the closed ends of the U-shaped frame members are far away from each other to form two ends of the annular column structure; the periphery of the annular column-shaped structure is used for being supported on the tricuspid valve of the human body;
the right ventricular side support pieces are distributed around the outer side of the annular column structure at intervals, one ends of the right ventricular side support pieces are respectively connected with the closed ends of the corresponding U-shaped frame members, and the other ends of the right ventricular side support pieces are arranged below the tricuspid valve diaphragm of the human body;
The right atrium side supporting pieces are arranged in a plurality, the right atrium side supporting pieces are distributed on the outer side of the annular column structure at intervals, one ends of the right atrium side supporting pieces are connected with the corresponding closed ends of the V-shaped frame members respectively, and the other ends of the right atrium side supporting pieces are arranged above the tricuspid valve diaphragm of the human body.
The self-stabilizing tricuspid valve support according to the embodiment of the invention has the following advantages: first, can guarantee that the relative position of self-stabilizing tricuspid valve support and human tricuspid valve diaphragm is fixed relatively between right atrium and right ventricle, can reduce the probability that self-stabilizing tricuspid valve support and human tricuspid valve diaphragm separate and drop by a wide margin, be favorable to promoting the operational reliability and the life of self-stabilizing tricuspid valve support. And secondly, the diaphragm is arranged on the inner periphery of the annular column-shaped structure of the self-stabilizing tricuspid valve support to form a prosthetic valve, so that the prosthetic valve can replace the tricuspid valve of a human body to stably play the function of the tricuspid valve of the human body.
In some embodiments, the number of right atrial side supports is consistent with the number of V-shaped frame members, the number of right atrial side supports being 10-20 and evenly distributed along the outside of the loop column structure; the number of the right ventricular side supporting pieces is less than or equal to that of the right atrium side supporting pieces, and the number of the right ventricular side supporting pieces is 5-20 and is uniformly distributed along the outer side of the annular column-shaped structure.
In some embodiments, each V-shaped frame member includes two connected sides, the two sides are equal in length and each is 5 mm-15 mm, the two sides are symmetrical with respect to respective first centerlines, and a first included angle between the two first centerlines is 30 ° to 60 °.
In some embodiments, each of the right ventricular side supports includes a coupling, a curved link, and a right ventricular side support curved surface, both ends of the coupling being connected to the closed end of the corresponding U-shaped frame member and one end of the curved link, respectively, and the other end of the curved link being connected to the right ventricular side support curved surface.
In some embodiments, the U-shaped frame member and the coupling are arcuate, with the concave arcuate surface of the U-shaped frame member and the concave arcuate surface of the coupling facing each other.
In some embodiments, the curved link is symmetrical about its own second centerline; the right ventricle side supporting curved surface is in a protruding umbrella-like shape and is symmetrical relative to the second central line.
In some embodiments, the second included angle between the second center line and the angular bisector of the corresponding nearest adjacent two of the side edges is 15 ° to 30 °.
In some embodiments, the right ventricular side support surface has a normal projected area along the second centerline of 20mm 2~35mm2, and the maximum principal curvature on the right ventricular side support surface is no more than 0.35mm -1.
In some embodiments, each of the right atrium side supports includes a crank link and a right atrium side support crank, both ends of the crank link being connected to the closed end of the V-shaped frame member and the right atrium side support crank, respectively.
In some embodiments, the right atrium side support crank is ring-shaped, and a third included angle between an upper surface of the right atrium side support crank and a tangential plane of the corresponding V-shaped frame member is 75 ° to 95 °.
Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.
Detailed Description
Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative only and are not to be construed as limiting the invention.
A self-stabilizing tricuspid stent 1000 according to an embodiment of the present invention is described below in connection with fig. 1-6.
As shown in fig. 1 to 6, the self-stabilized tricuspid valve stent 1000 according to the embodiment of the present invention is an integrally formed structure including a loop column structure 1, a right ventricular side support 2 and a right atrial side support 3.
Specifically, as shown in fig. 1 and 2, the annular columnar structure 1 is composed of a plurality of V-shaped frame members 101 located on one side and a plurality of U-shaped frame members 102 located on the other side, the plurality of V-shaped frame members 101 and the plurality of U-shaped frame members 102 are connected in a circular arrangement (as connected by a connecting section 1021 shown in fig. 5) alternately staggered in turn, forming the annular columnar structure 1 having a wavy feature, and the closed ends of the plurality of V-shaped frame members 101 and the closed ends of the plurality of U-shaped frame members 102 are spaced apart from each other to form both ends of the annular columnar structure 1. The annular column-shaped structure 1 is a main body part of the self-stabilizing tricuspid valve support 1000, has good compressibility and is uniformly stressed. The outer circumference of the annular cylindrical structure 1 is used for supporting on the tricuspid valve of the human body, that is, when the self-stabilized tricuspid valve support 1000 is installed in the tricuspid valve of the human body, the outer circumference of the annular cylindrical structure 1 is in contact with the tricuspid valve of the human body, and the inner circumference of the annular cylindrical structure 1 can be provided with a membrane made of biological material, and the function of the tricuspid valve of the human body can be exerted through the annular cylindrical structure 1 and the membrane on the inner side of the annular cylindrical structure 1.
The right ventricular side support members 2 are plural, the plural right ventricular side support members 2 are distributed around the outer side of the annular columnar structure 1 at intervals, one ends of the plural right ventricular side support members 2 are respectively connected with the closed ends of the corresponding U-shaped frame members 102, and the other ends of the plural right ventricular side support members 2 are arranged below the tricuspid valve membrane 4 of the human body (as shown in fig. 1 to 4). That is, when the self-stabilized tricuspid valve support 1000 is mounted in the tricuspid valve of the human body, the closed end of the U-shaped frame member 102 on the other side of the ring-shaped columnar structure 1 is directed to the right ventricle side, so that the other ends of the plurality of right ventricular side supports 2 are disposed under the tricuspid valve diaphragm 4 of the human body, when the self-stabilized tricuspid valve support 1000 is caused to move to the right atrium by contraction of the right ventricle (see upward moving arrow M in fig. 4), the plurality of right ventricular side supports 2 will come into contact with the lower surface portion of the tricuspid valve diaphragm 4 of the human body, preventing the self-stabilized tricuspid valve support 1000 from moving upward (i.e., to the right atrium), and the self-stabilized tricuspid valve support 1000 is stably held at the position of the tricuspid valve diaphragm 4 of the human body by the plurality of right ventricular side supports 2. Since the plurality of right ventricular side supporting pieces 2 are distributed around the outer side of the annular column-shaped structure 1, the whole self-stabilizing tricuspid valve support 1000 is favorable for uniform stress and good mechanical stability.
The right atrium side supporting pieces 3 are multiple, the right atrium side supporting pieces 3 are distributed on the outer side of the annular column-shaped structure 1 at intervals, one ends of the right atrium side supporting pieces 3 are respectively connected with the closed ends of the corresponding V-shaped frame members 101, and the other ends of the right atrium side supporting pieces 3 are used for being arranged above the tricuspid valve diaphragm 4 of the human body (as shown in fig. 1 and 4). That is, when the self-stabilized tricuspid valve support 1000 is mounted in the tricuspid valve of the human body, the closed end of the V-shaped frame member 101 on the side of the ring-shaped columnar structure 1 is directed to the right atrium side, so that the other ends of the plurality of right-atrium side supports 3 are disposed above the tricuspid valve diaphragm 4 of the human body, when the self-stabilized tricuspid valve support 1000 is caused to move to the right ventricle by the right ventricular diastole (see downward movement arrow N in fig. 4), the plurality of right-atrium side supports 3 will come into contact with the upper surface portion of the tricuspid valve diaphragm 4 of the human body, preventing downward (i.e., rightward ventricular) movement of the self-stabilized tricuspid valve support 1000, and the downward movement tendency of the self-stabilized tricuspid valve support 1000 is prevented by the plurality of right-atrium side supports 3, thereby being stably maintained at the position of the tricuspid valve diaphragm 4 of the human body. The right atrium side supporting pieces 3 are distributed around the outer side of the annular columnar structure 1, so that the whole self-stabilizing tricuspid valve support 1000 is favorable for uniform stress and good mechanical stability.
According to the self-stabilizing tricuspid valve support 1000 of the embodiment of the invention, a plurality of V-shaped frame members 101 and a plurality of U-shaped frame members 102 are connected in a circular arrangement in a staggered manner in sequence to form a ring column-shaped structure 1 with wavy characteristics, a plurality of right ventricular side supporting members 2 are arranged around the ring column-shaped structure 1 outside the ring column-shaped structure 1 and connected with the closed ends of the corresponding U-shaped frame members 102, and a plurality of right atrial side supporting members 3 are arranged around the ring-shaped structure and connected with the closed ends of the V-shaped frame members 101, so that the overall structure is simple and easy to process and shape.
Since the ventricle plays a far more important role than the atrium in cardiac pumping activity, the self-stabilizing tricuspid valve stent 1000 can be analyzed in terms of both the systolic and diastolic phases of the right ventricle of cardiac pumping activity in one cardiac cycle. In addition, prosthetic valves are intended to function in place of the human tricuspid valve, provided that the stent to which the prosthetic valve is mounted (e.g., the self-stabilizing tricuspid valve stent 1000 of embodiments of the present invention) must be able to maintain a relatively stable position during the cardiac cycle.
While the self-stabilizing tricuspid valve support 1000 according to the embodiment of the present invention is mounted in the tricuspid valve of the human body, the outer circumference of the annular columnar structure 1 is in contact with the tricuspid valve of the human body, and the closed end of the U-shaped frame member 102 on the other side of the annular columnar structure 1 is directed to the right ventricle side, so that the other ends of the plurality of right ventricle side supporting members 2 are disposed below the tricuspid valve diaphragm 4 of the human body, and the closed end of the V-shaped frame member 101 on the side of the annular columnar structure 1 is directed to the right atrium side, so that the other ends of the plurality of right atrium side supporting members 3 are disposed above the tricuspid valve diaphragm 4 of the human body.
When the right ventricle contracts, particularly in the isovolumetric contraction period and the rapid ejection period, the right ventricular internal pressure rapidly rises, and the self-stabilized tricuspid valve support 1000 moves in the right atrial direction (see upward movement arrow M in fig. 4) after being forced, the other end of the right ventricular side support 2 will come into contact with the lower surface portion of the tricuspid valve diaphragm 4 of the human body, preventing upward (i.e., rightward atrial direction) movement of the self-stabilized tricuspid valve support 1000. The self-stabilizing tricuspid stent 1000 is stably maintained in position at the tricuspid diaphragm 4 of the human body by the plurality of right ventricular side supports 2; similarly, upon relaxation of the right ventricle, particularly during rapid and slow filling phases, when the right ventricle is depressed below the intra-atrial pressure, the self-stabilizing tricuspid valve support 1000 is forced downwardly (i.e., in the right ventricular direction) toward the human tricuspid valve diaphragm 4 (see downward movement arrow N in fig. 4), the other end of the right atrial side support 3 will contact the upper surface of the human tricuspid valve diaphragm 4, preventing downward movement of the self-stabilizing tricuspid valve support 1000, and the tendency of downward movement of the self-stabilizing tricuspid valve support 1000 is prevented under the support of the plurality of right atrial side supports 3. Therefore, the relative positions of the self-stabilized tricuspid valve support 1000 and the human tricuspid valve diaphragm 4 can be ensured to be relatively fixed between the right atrium and the right ventricle, the probability of the self-stabilized tricuspid valve support 1000 separating from the human tricuspid valve diaphragm 4 and falling off can be greatly reduced, and the working reliability and the service life of the self-stabilized tricuspid valve support 1000 can be improved. On the premise of ensuring that the relative positions of the self-stabilized tricuspid valve support 1000 and the tricuspid valve diaphragm 4 of the human body are relatively fixed, the self-stabilized tricuspid valve support 1000 of the embodiment of the invention adopts the structure that a plurality of V-shaped frame members 101 and a plurality of U-shaped frame members 102 are sequentially and alternately staggered and are connected along a circular arrangement to form the annular column-shaped structure 1 with wavy characteristics, and the annular column-shaped structure 1 has good compressibility and uniform stress, and can stably play the function of the tricuspid valve of the human body after the inner periphery of the annular column-shaped structure 1 is provided with a diaphragm.
The self-stabilizing tricuspid stent 1000 according to the embodiments of the present invention has the following advantages: first, can guarantee that the relative position of self-stabilizing tricuspid valve support 1000 and human tricuspid valve diaphragm 4 is fixed relatively between right atrium and right ventricle, can reduce the probability that self-stabilizing tricuspid valve support 1000 separates and drops with human tricuspid valve diaphragm 4 by a wide margin, be favorable to promoting the operational reliability and the life of self-stabilizing tricuspid valve support 1000. Second, a diaphragm is arranged on the inner periphery of the annular column-shaped structure 1 of the self-stabilizing tricuspid valve support 1000 to form a prosthetic valve, so that the prosthetic valve can replace the tricuspid valve to stably play the function of the tricuspid valve.
In some embodiments, the number of right atrial side supports 3 corresponds to the number of V-shaped frame members 101, the number of right atrial side supports 3 being 10-20 and being evenly distributed along the outside of the ring-column structure 1; the number of right ventricular side supports 2 is less than or equal to the number of right atrial side supports 3, and the number of right ventricular side supports 2 is 5 to 20 and is uniformly distributed along the outer side of the annular columnar structure 1. It will be appreciated that the number of V-shaped frame members 101 and U-shaped frame members 102 constituting the ring column structure 1 is the same, and the number of the right atrium side supporting members 3 is the same as the number of the V-shaped frame members 101, that is, one V-shaped frame member 101 is connected to one U-shaped frame member 102, and a plurality of V-shaped frame members 101 are connected to a plurality of U-shaped frame members 102 in a one-to-one correspondence (as shown in fig. 1), so that when the number of the right atrium side supporting members 3 is 10-20, the number of the V-shaped frame members 101 and the U-shaped frame members 102 is 10-20, and the number of the V-shaped frame members 101 and the U-shaped frame members 102 can be selected to be matched according to the size of the tricuspid valve of the human body, which is beneficial for improving the adaptability of the self-stabilized tricuspid stent in the human body. The number of the right atrium side supporting pieces 3 is consistent with that of the V-shaped frame members 101 and the right atrium side supporting pieces are uniformly distributed, so that the uniformity and the stability of stress of the self-stabilizing three-tip support can be improved. The number of the right ventricular side supporting pieces 2 can be the same as that of the right atrial side supporting pieces 3 and are uniformly distributed, so that the uniformity and the stability of stress of the self-stabilizing three-point support can be improved. Preferably, as shown in fig. 1 and 2, the number of right ventricular side supports 2 may be smaller than the number of right atrial side supports 3 and uniformly distributed, so that not only uniformity and stability of stress of the self-stabilized tricuspid valve stent 1000 may be improved, but also interference between the other end of the right ventricular side support 2 and a large number of chordae in the right ventricle may be avoided.
In some embodiments, as shown in fig. 3, each V-shaped frame member 101 includes two connected sides 1011, the two sides 1011 may be connected by a connecting side 1012, the two sides 1011 may have equal lengths and may each be 5mm to 15mm, the two sides 1011 may be symmetrical with respect to respective first centerlines 10111, and a first angle α between the two first centerlines 10111 may be 30 ° to 60 °. In this way, the uniformity of stress of the self-stabilizing tricuspid valve support 1000 in all directions is ensured, and the structure that the two side edges 1011 of each V-shaped frame member 101 form the first included angle α with each other is convenient for compression and can ensure that the stress of the whole structure of the self-stabilizing tricuspid valve support 1000 is uniform.
In some embodiments, each right ventricular side support 2 includes a coupling 201, a curved link 202, and a right ventricular side support curved surface 203, where two ends of the coupling 201 are connected to the closed end of the corresponding U-shaped frame member 102 and one end of the curved link 202, respectively, and the other end of the curved link 202 is connected to the right ventricular side support curved surface 203. It will be appreciated that the right ventricular side supporting curve 203 is connected to the closed end of the U-shaped frame member 102 by the curved link 202 and the coupling member 201, and is capable of bypassing chordae tendineae in the right ventricle to contact the lower surface portion of the tricuspid valve membrane 4 of the human body, thereby providing a supporting function.
In some embodiments, as shown in fig. 4, the U-shaped frame member 102 and the coupling 201 are arcuate, with the concave arcuate surfaces of the U-shaped frame member 102 and the coupling 201 facing each other, which facilitates the right ventricular side support 2 to bypass chordae tendineae in the right ventricle.
In some embodiments, as shown in FIG. 4, curved link 202 is symmetrical with respect to its own second centerline 2021; the right ventricular-side supporting curved surface 203 is convex umbrella-like and symmetrical with respect to the second center line 2021. In this way, the right atrium side support member 3 can be uniformly stressed.
In some embodiments, the second included angle β between the second centerline 2021 and the bisector 1013 corresponding to the nearest adjacent two sides 1011 is 15 ° to 30 °. That is, the second angle β is understood here as the angle between the second center line 2021 of the curved link 202 of the right ventricular side support member 2 and the bisector 1013 of the two side edges 1011 of the right ventricular side support member 3 connected by the U-shaped frame member 102 as shown in fig. 4. When the second included angle beta is 15-30 degrees, the right ventricle side supporting piece 2 can bypass chordae tendineae in the right ventricle, so that the right ventricle side supporting curved surface 203 contacts the lower surface part of the tricuspid valve diaphragm 4 of the human body, and the supporting function is achieved.
In some embodiments, the normal projected area of the right ventricular side supporting curved surface 203 along the second centerline 2021 is 20mm 2~35mm2, and the maximum principal curvature on the right ventricular side supporting curved surface 203 is no more than 0.35mm -1. This increases the contact area between the right ventricular side supporting curved surface 203 and the lower surface portion of the tricuspid valve membrane 4, and reduces stress concentration.
In some embodiments, right atrium side support 3, fig. 3 and 4, includes a crank link 301 and a right atrium side support crank 302, with both ends of crank link 301 connected to the closed end of V-shaped frame member 101 and right atrium side support crank 302, respectively. It will be appreciated that right atrium side support crank 302 is connected to the closed end of V-shaped frame member 101 by crank link 301, and crank link 301 may be curved such that right atrium side support crank 302 contacts the upper surface of tricuspid valve membrane 4 for support.
In some embodiments, as shown in fig. 1,4 and 6, crank link 301 may be arcuate in shape, further facilitating right atrium side support crank 302 to contact the upper surface of tricuspid valve membrane 4.
In some embodiments, as shown in fig. 6, the right atrium side supporting crank 302 has a circular ring shape, and a third included angle γ between an upper surface of the right atrium side supporting crank 302 and a tangential plane 10112 of the corresponding V-shaped frame member 101 is 75 ° to 95 °. In this way, the right atrial side support crank 302 is advantageously supported on the upper surface portion of the tricuspid valve membrane 4.
In the description of the present specification, reference to the terms "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
While embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that: many changes, modifications, substitutions and variations may be made to the embodiments without departing from the spirit and principles of the invention, the scope of which is defined by the claims and their equivalents.