KR20200052600A - Artificial cardiac valve and Artificial cardiac valve set comprising the same - Google Patents

Abstract

The present invention relates to an artificial heart valve for non-suturing aortic valve implantation, and an artificial heart valve set including the same. When non-suturing aortic valve implantation is performed by utilizing the artificial heart valve set of the present invention, an artificial heart valve which is in a state in which a skirt portion is tightened before insertion into a human body is provided so insertion into the human body can be performed very easily. In addition, the artificial heart valve and a mounting tool are separated very quickly and safely by cutting, by an operator, a connecting member during insertion into a human aortic tube, and thus a procedure time can be significantly shortened. Moreover, when the connecting member is cut, the skirt portion can be instantaneously expanded to be stably mounted to the aortic tube. Furthermore, as the skirt portion of the present invention is made of a shape memory alloy, the skirt portion can be stably restored to a predetermined shape under a human body inner condition to ensure more stable mounting of the artificial heart valve.

Description

Artificial heart valve and artificial cardiac valve set comprising the same}

The present invention relates to an artificial heart valve, and more particularly, to an artificial heart valve for non-sealing aortic valve replacement and a set of artificial heart valves including the same.

Sutureless Aortic Valve Replacement (SU-AVR) is a method in which an artificial valve is inserted without a suture process, making it difficult to perform conventional surgical aortic valve replacement (SAVR). It has been provided to patients with high-risk groups to perform an artificial valve insertion procedure to restore heart valve function in the shortest possible time.

According to the new medical technology evaluation report HTA-2014-35 (2014.9), the mean cross-clamp time (CCT) for valve replacement of SU-AVR is 38.9-66 minutes and the average cardiopulmonary bypass time is time, CPBT) takes 68.9 ~ 100 minutes, while the average aortic block time for valve replacement procedure of conventional SAVR procedure is 66 ~ 93 minutes and the average cardiopulmonary bypass time is reported to take 105 ~ 124 minutes, SU- It can be confirmed that the AVR procedure is performed faster than in the prior art.

As the risk of the prosthetic valve insertion procedure is greatly reduced by the shortening of the procedure time, the artificial heart valve insertion procedure of high-risk patients diagnosed with aortic valve stenosis, aortic insufficiency, or stenosis and dysfunction is facilitated. In addition, research and development are underway to perform faster, more stable and safer non-sealing aortic valve replacement.

As an example, U.S. Patent Publication No. 2010-0004727 discloses a valve prosthesis including a thread structure supporting means as an artificial heart valve that can be used for the treatment of aortic stenosis. As the procedure for expanding the valve prosthesis using a balloon catheter for stable fixation is separately performed, there is a limitation in that the procedure time of the entire aortic valve replacement procedure is significantly shortened.

As another example, in US Patent Publication No. 2015-0320556, a shape memory alloy material is applied to a metal support frame, and the artificial heart valve is inserted into the body in a compressed state, and then expanded to a functional size according to balloon expansion or self-expansion at a desired position. Although artificial heart valves have been disclosed, even for medical devices made of shape enterprise alloys, it takes a long time to self-expand to a functional size in a fully compressed state, and balloon expansion is performed to shorten the self-expansion time. Even if carried out, there is a disadvantage in that an additional surgical process for this is inevitable.

1. US Patent Publication No. 2010-0004727 (Jan. 2010) 2. US Patent Publication No. 2015-0320556 (Nov. 12, 2015)

An object of the present invention is to provide an artificial heart valve that enables rapid and safe aortic valve replacement by allowing the artificial heart valve to be stably mounted simultaneously with insertion into the aortic tube in non-sealed aortic valve replacement.

In addition, another object of the present invention is to provide a set configuration for inserting an artificial heart valve in an aortic canal that is optimized for performing a non-sealing aortic valve replacement.

An artificial heart valve according to an embodiment of the present invention for achieving the above object, in an artificial heart valve including an artificial valve and a stent, the stent is a hollow cylindrical body portion; and extending from the body portion It comprises a hollow conical skirt portion whose diameter is gradually increased in one direction, and at least the skirt portion is made of wires interwoven or cross-formed so that the entire structure can be self-restored by elastic deformation.

At this time, it may further include a tightening portion for fixing the skirt portion in a compressed state below the diameter of the main body portion.

At this time, the fastening portion is composed of a suture-shaped connecting member capable of binding the edges of the skirt portion in a compressed state, and the removal of the connecting member, the cutting state is released to release the compressed state, so that the skirt portion can be restored.

On the other hand, the main body portion and the skirt portion are made of wires interwoven or cross-formed in the form of a mesh, but the main body portion has a shape in which the wires are intertwined, and each of the bent portions is from top to bottom and from bottom to top. While crossing each other to include a structure intertwined to have a rhombic shape, the skirt portion may be configured to include a structure consisting of a weave-shaped weave so that the intertwined wires cross each other up and down once. On the other hand, the artificial heart valve set according to another embodiment of the present invention for achieving the above object, the artificial heart valve and the artificial heart valve in order to seat the desired position in the form of the artificial heart valve mounted A set of artificial heart valves comprising a mounting tool provided together, the artificial heart valves comprising a stent that is a fixed support means in the aortic canal of the heart connection site and an artificial valve fixed to the stent, wherein the stent is hollow It includes a cylindrical body portion and a skirt portion of a hollow conical shape extending from the body portion and gradually increasing in diameter in one direction, wherein at least the skirt portion is wired in a mesh shape or intersected so that it can be restored to its shape by elasticity. It consists of a formed structure,

The mounting tool comprises a center, a plurality of supports extending radially spaced apart from the center, and a first fixing member supporting the structure of the mounted artificial heart valve, and the artificial heart A second fixing formed at the center end of the position corresponding to the edge of the skirt part in a state in which the valve is mounted, and supporting a suture-type connecting member that fixes the diameter of the skirt part to a diameter less than or equal to the diameter of the body part. It may be configured to include a member.

At this time, the second fixing member, when the diameter of the edge of the skirt portion of the hollow conical shape is compressed to the diameter of the body portion or less by the connecting member, to serve as a central support for concentric compression of the edge of the skirt portion It may include at least one through-hole through the connecting member extending from the skirt portion.

At this time, the through-hole has a structure that receives the connecting member extending from the skirt portion and guides it in the direction of the first fixing member,

The tension generated in the connecting member to compress the skirt portion is extended from the edge of the skirt portion and the connecting member guided in the direction of the first fixing member via the second fixing member is connected to the first fixing member. It can be configured to be maintained.

At this time, the tension generated in the connecting member in order to compress the skirt part is caused by the knotting of the connecting member on the path of the connecting member connecting the edge of the skirt part, the second fixing member and the first fixing member to each other. On the other hand, the knot for maintaining the tension generated in the connecting member may be configured to be formed on the outer surface of the first fixing member.

At this time, on the outer surface of the first fixing member, a knotting hole through which the connecting member can be inserted is formed, and the knot is the first fixing member in a state where the connecting member inserts and penetrates the knotting hole. Formed on the outer surface of the, when cutting a point of the connecting member in order to release the compression of the skirt portion, the connecting member cut by the knot is caught in the knotted hole is separated from the mounting tool and lost In order to prevent being, the diameter of the knot hanging hole may be characterized in that it is formed to be smaller than the diameter of the knot.

According to the artificial heart valve according to an embodiment of the present invention, as a quick and stable and safe insertion of an artificial heart valve is performed during a non-sealed aortic valve replacement operation, the procedure time of the entire non-sealed aortic valve replacement procedure is shortened and the side effects of the procedure are reduced. There is an effect that can be made. In addition, according to this, there is an effect that a relatively safe operation can be performed on a high-risk group patient having difficulty in performing aortic valve replacement.

In addition, according to the artificial heart valve set according to another embodiment of the present invention, by providing an artificial heart valve set configuration for inserting an artificial heart valve in an aortic tube in an optimized state for performing a non-sealing aortic valve replacement, There is an effect that can improve the treatment convenience of the non-sealing aortic valve replacement.

1 is a photograph showing the overall shape of an artificial heart valve according to an embodiment of the present invention.
Figure 2 is a photograph showing the front of the artificial heart valve of Figure 1;
FIG. 3 is a cross-sectional view of part “A” of FIG. 2.
FIG. 4 is a cross-sectional view of part “B” of FIG. 2.
5 is a photograph showing the overall structure of the stent so as to confirm the wire length of the stent of the artificial heart valve according to an embodiment of the present invention.
Figure 6 (a) and Figure 6 (b) is a reference diagram showing the structure of a wire weave that can be applied to the artificial heart valve body portion and the skirt portion according to an embodiment of the present invention.
7 is a view showing the use of an artificial heart valve showing a state in which the skirt portion of FIG. 4 is tightened.
8 is a rear view of the fastening portion of the artificial heart valve according to an embodiment of the present invention.
9 is a perspective view showing the structure of the mounting tool in the artificial heart valve set according to an embodiment of the present invention.
FIG. 10 is a view showing the use of an artificial heart valve set for illustrating a state in which the artificial heart valve of FIG. 1 is fastened to the mounting tool of FIG. 9.
11 is a use diagram for explaining the state of the tightening portion and the path of the connecting member in the artificial heart valve set according to the embodiment of the present invention.
12 is a rear view showing the fastening portion of the artificial heart valve set according to an embodiment of the present invention.
FIG. 13 is a perspective view for showing an embodiment of the portion “C” of FIG. 10.
14 is a perspective view for showing another embodiment of part “C” of FIG. 10.

Hereinafter, various embodiments of the present invention will be described with reference to the accompanying drawings. It should be understood that the examples and terms used therein are not intended to limit the technology described in the present invention to specific embodiments, but include various modifications, equivalents, and / or substitutes of the examples. In connection with the description of the drawings, similar reference numerals may be used for similar components. Singular expressions may include plural expressions unless the context clearly indicates otherwise.

At this time, unless there are other definitions in the technical terms and scientific terms to be used, it has a meaning commonly understood by those of ordinary skill in the art to which this invention belongs, and the gist of the present invention in the following description and the accompanying drawings Descriptions of well-known functions and configurations that may be obscured are omitted.

As a surgical method for shortening the patient's recovery time and the recovery time of the prosthetic valve insertion procedure to restore the heart valve function in patients at high-risk groups who are difficult to perform surgical aortic valve replacement, a non-sutured aortic valve Substitutions are provided.

The present invention is to provide a configuration of an artificial heart valve 100 and an artificial heart valve set 200 in which the stability, safety, and surgical convenience are optimized in the non-sealing aortic valve replacement.

First, the artificial heart valve 100 of the present invention is a heart valve that serves as an opening door of blood between the left ventricle and the aorta, and includes an artificial valve 110 and a stent 130 as shown in FIGS. 1 to 8. The artificial heart valve 100, the stent 130 includes a body portion 135 and a skirt portion 137, and at least the skirt portion 137 of the stent 130 is wire 131 is woven in a mesh or It can be characterized in that it is formed by cross-forming. Here, the wire is intertwined or formed in the form of a mesh is called the weaving of the wire. At this time, a number of mesh-shaped spaces may be formed by the weaving of the wire.

Referring to Figures 1 to 4, the artificial valve 110 is a portion that refers to the valve portion of the artificial heart valve 100, it is preferable to be a biotissue valve to effectively prevent the retrograde flow while reducing rejection, more Specifically, a special chemically treated small pericardium or porcine pericardium valve such as acellularization may be used.

The stent 130 is a kind of frame on which the artificial valve 110 is mounted. Referring to FIGS. 5 and 6 (a) and 6 (b), the stent 130 according to the present invention is hollow It includes a cylindrical body portion 135 and a hollow conical skirt portion 137, and the body portion 135 is positioned on the side of the aortic vessel based on the position of the aortic valve and the skirt portion 137 is caught on the left ventricle side. It is characterized by being seated.

Here, the body portion 135 is a hollow cylindrical shape and the artificial valve 110 is located inside. Specifically, the main body portion 135 of the present invention is formed with three projections on one side to support three artificial valves 110, and each of the main body portions (110) is adjacent to the artificial valve 110 as a contact point. It is sewn and sewn with a thread such as a suture along the outer line of 135).

In addition, the skirt portion 137 is a hollow cone shape that gradually increases in diameter in one direction, and is connected to the body portion 135 in the opposite direction in which the artificial valve 110 is mounted. Here, the main body portion 135 and the skirt portion 137 of the stent 130 are connected to each other, but it is possible that the main body portion 135 and the skirt portion 137 are respectively or integrally formed. At this time, at least the skirt portion 137 may be characterized in that the entire structure is elastically deformable so that the elastically deformable wire 131 is woven in a mesh form or cross-formed.

That is, in the stent 130, the body portion 135 and the skirt portion 137 formed by intertwining the wire 131 are independently manufactured and connected, or the wire mesh structure interwoven in the same format is integrally the body portion 135 ) And the skirt part 137, and may have a stent 130 structure in which the main body part 135 and the skirt part 137 having different wires 131 in different forms and shapes are integrally connected. . At this time, while facilitating the manufacture of the artificial heart valve 100, in the aspect of minimizing the structural deformation or defect occurrence of the stent 130 during the procedure of the artificial heart valve 100, the body portion 135 and the skirt portion 137 It is most preferred to be integral.

For example, as shown in FIG. 5, in the case of the stent 130 in which the body portion 135 and the skirt portion 137 are integrally formed, the body portion 135 is easy to extend the length of the upper and lower axial axis in the aortic tube while the aortic tube One wire 131 and the other wire 131 may be cross-linked at least once and intertwined so as to be properly applied to the shape of the medial blood vessel. Specifically, the main body portion 135 is the first wire 10 and the second wire 11, which are two superelastic shape memory alloy materials, as disclosed in Patent Registration No. 457629 and FIG. As each of the wires 10 and 11 crosses each other from the top to the bottom and the bottom to the top while undergoing the process of cross-bending at different positions, the spaces of the lozenge-shaped spaces that are variable and the distances from each other are staggered. The crossing portion 70 is partially formed between the same circumferential direction and the staggered portion 60 in the longitudinal direction so as to have a repulsive force against the staggered portion 60 and the shrinkage in the longitudinal direction. It can be formed according to the manufacturing method of the variable-state maintenance type expansion mechanism.

The staggered portion 60 has a structure in which wires 10 and 11 traveling in different directions are interwoven with each other and progress in different directions, and is also referred to as a “hook”, and the stent 130 is a curved portion of the lumen It is constructed and acts to maintain the same shape without resistance.

On the other hand, the skirt portion 137 is a conical shape extending in the left and right direction, so that one wire 131 and the other wire 131 are intersected up and down once in order to stably rest at the position of the aortic valve. It is preferred to consist of a (woven) form of weaving. Specifically, as shown in the patent application No. 457629 and FIG. 6 (b) of the applicant's pre-applied patent, the skirt portion 137 does not involve bending stress or elongation, and ensures stable restoration in a preset form. It can be made to form a rhombus-shaped cell having only a straight cross section 70 by simple intersecting wires 10 and 11.

That is, the body portion 135 has a structure in which the bent portions of the bent wires 131 are formed to have a mesh structure in a locking form with each other, so that the shape is easy to deform according to the shape of the seated blood vessel rather than the elastic restoring force. , The skirt portion 137 has a woven mesh structure, and is excellent in elastic resilience, so as to not only maintain a stable locking position at the left ventricular aortic outlet, but also secure the locking position in a compressed state according to the characteristic configuration of the present invention. For the shape restoration for the quick and accurate to occur, this configuration and operation will be described in more detail later.

At this time, the wire 131 of the body portion 135 and the wire 131 of the skirt portion 137 may be the same wire extending without a short circuit, thereby integrally forming the body portion 135 and the skirt portion 137. It may be possible.

In addition, it is preferable that the wire 131 is made of a material having an elasticity guaranteed to be able to restore its own shape, and specifically, it may be made of a superelastic shape memory alloy such as Nitinol so as to be stably restored to a preset shape in human conditions. . The expansion mechanism manufactured to have a diameter and length set by using the superelastic shape memory alloy wire 131 has elastic force in the radial direction and the longitudinal direction to always return to an initial state unless it is forcibly suppressed by an external force. .

On the other hand, according to FIGS. 7 to 8, according to an embodiment of the present invention, the skirt portion 137 of the stent 130 is provided in a compressed state before an insertion procedure is performed in the human body, and accordingly, the body portion 135 ) It further includes a fastener 150 fixed in a compressed state to a diameter or less. That is, while the skirt portion 137 of the artificial heart valve 100 is extended outward as shown in FIG. 4, the tightening portion 150 is formed while being compressed inward by the tightening of the connecting member 151 as shown in FIG. 7. Will be.

The tightening part 150 is not greatly limited as long as it is a means to keep the edge of the skirt part 137 fixed in a compressed state, but is easy to apply to the skirt part 137 and enables custom design changes according to the procedure situation. In order to do so, it is characterized in that it consists of a connecting member 151 capable of tying the edges of the skirt portion 137 in a compressed state, wherein the connecting member 151 may be a thread in the form of a suture used during surgery in the human body.

In addition, the fastening part 150 is provided in a form in which at least one connecting member 151 is bound to the edge of the skirt part 137 and tightened to a diameter of the body part 135 or less, and preferably, a plurality of connecting members 151 ) Is preferably formed by balancing in a radially spaced apart form, and more preferably, as the basic shape of the stent 130 is cylindrical, the pair is positioned symmetrically to each other in order to balance the fastener 150. It is preferable that an even number of connecting members 151 are formed. As an example, as shown in FIG. 8, the six parts of the skirt portion 137 are tightened by radially three pairs (six) of connecting members 151 to maintain the balance of the tightening portion 150 most appropriately. It may be a knot 155 in a state.

On the other hand, as shown in Figures 2 to 4, the artificial heart valve 100 further includes an outer shell 170 surrounding the surface, and may further include a suture ring 180 to induce stable seating at the position of the aortic valve. . Accordingly, in the configuration of the artificial heart valve 100 of the present invention, in addition to the configuration of the stent 130, the body portion 135, the skirt portion 137, etc. without further mention, the outer shell 170 and the suture ring 180 It is natural that at least one component may be further included.

Here, the outer shell 170 is a cloth covered to wrap along the surface of the stent 130, and is a portion directly contacting the inside of the aortic blood vessel. The outer shell 170 can be used without limitation as long as it is a material having biocompatibility characteristics. For example, the biocompatibility characteristic is recognized and can be applied in the form of a polyester material commercially available as an implant material.

In addition, the suture ring 180 is configured to perform a function of allowing the artificial heart valve 100 to be supported without slipping in the lumen of the blood vessel without any discomfort in the lumen of the blood vessel because the skirt portion 137 is secured to the aortic valve position. It may be a catch formed in (130). Specifically, the suture ring 180 may be a hook in the form of a ring formed on the outside of the stent 130, and preferably, the artificial valve 110 of the stent 130 is positioned on the side of the aortic vessel based on the position of the aortic valve. It is preferred that the skirt portion 137 is formed in the central portion of the stent 130 to be suitable for positioning on the left ventricle side, more preferably between the body portion 135 and the skirt portion 137 of the stent 130 It is good to be located on.

In addition, the suture ring 180 may be formed by rolling a portion of the outer shell 170 in the form of a ring to fix it by sewing, or insert a morphological yarn made of the same material as the outer shell 170 into the outer ring 170 in a ring shape or It can also be configured by inserting the silicone ring 181. At this time, the suture ring 180 may be connected to the lumen of the aorta by using a suture in at least one portion to stably maintain a state of being seated in the position of the aortic valve.

On the other hand, briefly explaining the manufacturing method of the artificial heart valve 100 according to an embodiment of the present invention, first to prepare a stent 130 serving as a support. At this time, the stent 130 is woven so that one wire 131 and the other wire 131 cross at least once and cross each other, and the body portion 135 and the one wire 131 formed of a hollow cylindrical shape And the other one of the wire 131 is intertwined so as to cross each other up and down once and the skirt portion 137 made of a hollow conical shape is integrally formed with a short-circuited wire 131.

Subsequently, the artificial valve 110 and the outer shell 170 made of polyester material are placed on the stent 130 while the artificial valve 110 made of biological tissue or the like is positioned inside the body portion 135 of the stent 130. Suture and bond. At this time, in the middle portion of the outer shell 170, a ring made of a silicon material is placed and rolled with the outer shell 170 to form a suture ring 180.

Finally, the six parts spaced apart at regular intervals in the radial direction of the end of the skirt portion 137 of the stent 130 are sewn and tightened. At this time, in the state in which the sutures are tied to the six parts of the skirt portion 137, the skirt portions 137 are closed using a separate clamping mechanism, and each suture is maintained while the skirt portion 137 is tightened. By knotting it can form the fastener 150.

On the other hand, the artificial heart valve set 200 according to another embodiment of the present invention, as shown in Figures 9 and 10, the artificial heart valve 100 and the artificial heart valve 100 is mounted mounting tool 300 It includes. That is, the artificial heart valve set 200 has a configuration in which the mounting tool 300 is coupled to the artificial heart valve 100 described above, and the mounting tool 300 is seated at the desired position of the artificial heart valve 100. In order to do so, it is characterized in that the artificial heart valve 100 is provided together in a mounted form.

The mounting tool 300, as shown in Figure 9, the center portion 310 and the first fixing member 330 for fixedly supporting the above-described artificial heart valve 100 and the skirt portion of the artificial heart valve 100 ( 137) a second fixing member 350 for supporting the connecting member 151 to tighten.

Here, the center stage 310 is a rod shape of a certain length, and while being able to handle antibacterial and sterile while securing a certain degree of stiffness, it is not particularly limited as long as it is a material that can be used in human surgery. In addition, in the case of the artificial heart valve 100, the operator or the surgical assistant may directly hold the end of the center 310 and perform the artificial heart valve set 200 to a delivery aid such as a catheter or robot arm. It may be performed by binding, in which case the end of the center stage 310 may be provided in a shape that can be attached to each of the transmission aids.

In addition, the first fixing member 330 includes a plurality of supports 331 radially extending from the center 310, and the supports 331 are mounted and fixed to the artificial heart valve 100 and the artificial heart valve 100 ). At this time, in order to stably support the artificial heart valve 100, the center 310 is positioned at the inner center of the artificial heart valve 100 and the support 331 is positioned around the artificial heart valve 100. desirable. Further, a plurality of supports 331 may be radially spaced apart from the center 310 in order to support the cylindrical artificial heart valve 100 in a balanced manner.

Here, a plurality of support 331 is formed to support the artificial heart valve 100 is formed as shown in Fig. 9 or 10, the artificial heart valve 100 made of three artificial valve 110 to balance It can be desirable to have three supports 331 formed from the side for stably supporting and securing the operator's field of view.

The second fixing member 350 is fixedly formed at the end of the center 310, the skirt portion 137 to balance the skirt portion 137 of the artificial heart valve 100 fixed to the support 331 to balance The connecting member 151 extending from the edge is collected and supported in the center. Specifically, the artificial heart valve set 200 according to the present invention is provided in a state in which the diameter of the skirt portion 137 is tightened to a diameter equal to or less than the diameter of the body portion 135, and the second fixing member 350 is a skirt portion Supporting the connecting member 151, which is tightened in the compressed state (137), serves as a central feature that allows the tightened state of the skirt portion 137 to remain stable and balanced.

At this time, the second fixing member 350 is preferably located on the compression direction plane of the edge of the skirt portion 137 so as to efficiently receive and support the connecting member 151 extending from the skirt portion 137, Therefore, it is preferable to be formed at a position corresponding to the end of the skirt portion 137 in the longitudinal direction of the center stage 310. For example, the second fixing member 350 may be attached and fixed to the end of the center stage 310 formed at a position corresponding to the end of the skirt portion 137.

In addition, the second fixing member 350 is at least one through hole that is a path through which the connecting member 151 passes, in order to effectively collect and support the connecting member 151 extending from the artificial heart valve 100 to the center. It may include (351). That is, the through-hole 351 accommodates the connecting member 151 forming the fastening part 150 as shown in FIG. 12, thereby collecting the connecting member 151 extending from the edge of the skirt part 137 to the center. I can support.

Specifically, the fastening portion 150 is formed by tightening at least one portion along the edge of the skirt portion 137 with the connecting member 151 as described above, thereby penetrating the second fixing member 350 The hole 351 may be a path through which at least one strand of the connecting member 151 passes. In addition, at this time, one of the connecting members 151 is a thread (hereinafter referred to as a yam) that enters the skirt portion 137 of the artificial heart valve 100 from the outside and a thread (hereinafter referred to as a warp) that comes out from the skirt portion 137. It is included in a pair at the same time.

At this time, the through-hole 351 may collect and accommodate multiple strands of the connecting member 151 in a single through-hole 351, but several through-holes to prevent the multiple strands of the connecting member 151 from twisting each other It is preferable that the 351 is formed, and more preferably, each connecting member 151 is supported to prevent the twisting of each connecting member 151 while maintaining the shape of the balanced fastener 150. It is preferable that the number of the connecting members 151 and the number of through-holes 351 are the same so as to be accommodated in each through-hole 351.

In addition, as shown in Figure 11, the through-hole 351 may be formed with one-way so that the connecting member 151 is accommodated at the end portion of the skirt portion 137 and exits to the first fixing member 330 side. In this case, the connecting member 151 is guided in the direction of the first fixing member 330.

As an example, as shown in FIG. 12, the fastening part 150 may be formed in a form in which the six parts of the skirt part 137 are pulled to the six-member connection member 151 to be tightened, wherein the six-member connection member 151 Is received in each of the adjacent through-holes 351 among the six through-holes 351 and guided in the direction of the first fixing member 330 as shown in FIG. 11. Here, the one-strand connecting member 151 is a thread (hereinafter referred to as a yam) that enters the skirt portion 137 of the artificial heart valve 100 from the outside and a thread (hereinafter referred to as a warp) that comes out from the skirt portion 137. It is included in a pair at the same time.

The connecting member 151 guided from the skirt portion 137 through the through hole 351 to the first fixing member 330 is knotted in the first fixing member 330 as shown in FIGS. 13 and 14. (155) It is built. At this time, the connecting member 151 is made of a knot 155 on one side of the first fixing member 330 in a pulled state so that the tightening portion 150 of the artificial heart valve 100 is maintained. Specifically, the knot 155 may be formed around the support 331 of the first fixing member 330.

Here, the first fixing member 330, as shown in Figure 14, the connecting member 151 further comprises at least one knot hanging hole 335 to catch the knot 155 so as not to be separated from the mounting tool 300 Can be. The knot stiffening hole is at least one hole formed in the first fixing member 330 support 331, and may be formed to have a size through which the connecting member 151 passes but not the knot 155 of the connecting member 151. . Specifically, the diameter of the knot hanging hole 335 may be formed so as not to exceed twice the diameter of the connecting member 151 passing through the knot hanging hole 335. More specifically, at least one strand of the connecting member 151 may be passed through the knot hanging hole 335 according to an embodiment, and the connecting member 151 passing through the knot hanging hole 335 according to each embodiment If the diameter of the) is collected so that it is formed so as not to exceed twice the combined value, the passage of the connecting member 151 is possible, but the passing of the knot 155 of the connecting member 151 is impossible.

Accordingly, the connecting member 151 drawn out from the through-hole 351 passes through the knot-hanging hole 335 to form a knot 155, whereby the tension of the connecting member 151 generated by compressing the skirt portion 137 is At the same time, by cutting the connecting member 151 during the procedure, the compression of the skirt portion 137 is released, so that the extended skirt portion 137 can be quickly seated and fixed in the correct position, and the artificial heart valve 100 and When detaching the mounting tool 300, the knot 155 of the connecting member 151 is caught in the knot-hanging hole 335 to be separated from the mounting tool 300 and prevented from being lost. It is to help to be taken out from.

At this time, the knot 155 may be repeatedly knotted 155 several times to form a larger diameter than the diameter of the knot hanging hole 335. In addition, the position of the knot 155 is not limited as long as it is a position suitable for the operator to check the knot 155 during the procedure, but the operator knots when the artificial heart valve 100 and the mounting tool 300 are separated during the procedure. 155) It is preferable to be formed on the upper side of the first fixing member 330 from the side for easily checking the surroundings and cutting quickly and accurately, and specifically, the support 331 of the first fixing member 330 It is preferable to be formed on the upper side, and more preferably, it is good to be formed around the knot hole 335 of the first fixing member 330 in terms of improving procedure convenience and procedure stability.

In addition, the first fixing member 330 may further include a cutting groove 337 for cutting the connecting member 151. The cutting groove 337 is for cutting a portion of the extension line of the connecting member 151 passing through the first fixing member 330, specifically when the artificial heart valve 100 and the mounting tool 300 are separated during the procedure. At least one surface of the first fixing member 330 is concavely formed so that the operator can easily cut the connecting member 151 with a surgical cutter. At this time, the cutting groove 337 is preferably formed in the periphery of the knot hanging hole 335 so that the operator can easily determine the position of the knot 155 and cut the connecting member 151, and the knot 155 is the operator The cutting groove 337 is also formed on the upper side of the first fixing member 330 as it is formed on the upper side of the first fixing member 330 in consideration of the side for increasing the surgical stability by securing the field of view quickly and accurately. It is good. More specifically, it is preferably formed on the upper side of the support 331 of the first fixing member 330.

On the other hand, briefly according to an embodiment of the method of manufacturing the artificial heart valve set 200 of the present invention according to the above, first to prepare a stent 130 serving as a support 331. At this time, the stent 130 is woven so that one wire 131 and the other wire 131 cross at least once and cross each other, and is different from the body portion 135 made of a hollow cylindrical shape and one wire 131. One wire 131 is woven so that it intersects up and down once, and a skirt portion 137 made of a hollow conical shape is integrally formed with a wire 131 without a short circuit.

Subsequently, the artificial valve 110 and the outer shell 170 made of polyester are sealed to the stent 130 in a state where the special chemically treated artificial valve 110 is positioned inside the body portion 135 of the stent 130. Combine. At this time, in the middle portion of the outer shell 170, a ring made of a silicon material is placed and rolled with the outer shell 170 to form a suture ring 180.

Then, the ends of the skirt portion 137 of the artificial heart valve 100 are interwoven with each suture stitched into the needle at 6 intervals at regular intervals, and weaves each threaded thread extending from the skirt portion 137. Passing through the through hole 351 of the second fixing member 350 of 300 guides the upper side of the first fixing member 330 support 331. Thus, the artificial heart valve 100 and the mounting tool 300 are combined through the connection of the suture to form a set.

Here, the suture includes all of a pair of sutures in the direction of entering from the outside to the end of the skirt portion 137 and sutures in the direction from the skirt portion 137 to the outside when weaving through the end of the skirt portion 137.

Finally, in the state in which the suture weaving the six parts of the end of the skirt portion 137 is guided to the upper side of the support 331, the skirt portion 137 of the artificial heart valve 100 is clamped using a clamping mechanism, and thus Likewise, while holding the skirt portion 137 in a tightened state, each suture is knotted to form a tightening portion 150. Then, the remaining sutures around the knot 155 are cut off to finish.

On the other hand, briefly explaining the method of performing the aortic valve replacement of the human body using the artificial heart valve set 200 according to the present invention, first, the artificial heart valve set 200 of the present invention is prepared and placed on the position of the aortic valve as a surgical site. The artificial heart valve 100 is positioned. At this time, a part of the artificial heart valve 100 may be partially sealed to the lumen of the aortic tube in order to support and fix the artificial heart valve 100 and prevent separation.

Subsequently, the connecting member 151 around the knot 155 of the connecting member 151 formed on the first fixing member 330 of the mounting tool 300 is cut with a surgical cutter. At this time, the cutting is performed by cutting the connecting member 151 around each knot 155 in the cutting groove 337 of the first fixing member 330.

Finally, the mounting tool 300 is moved from the surgical site to the outside of the human body. At this time, while the artificial heart valve 100 is mounted at the position of the aortic valve, the mounting tool 300 is moved to the outside of the human body, and the connecting member 151 has the knot 155 hooked on the mounting tool 300 and naturally goes out of the human body. It is taken out. Thus, the separation procedure of the artificial heart valve 100 and the mounting tool 300 is performed.

On the other hand, since the present invention relates to the operation of the heart, which is a very important organ in the human body, it is natural that the present invention is a very important factor as well as convenience of manufacture and procedure, as well as securing stability. Accordingly, the present invention is characterized in knotting a suture according to a pre-designed knotting method in order to make a quick and safe separation procedure with minimal treatment during a separation procedure for separating an artificial heart valve from a mounting tool.

In detail, the knot according to the embodiment of the present invention is to prevent the sutures from being twisted by interlocking with each other as the fastener is formed by several strands of sutures and to prevent a dangerous situation in which the sutures remain in the human body after the separation procedure. , Several strands of sutures can be crossed and knotted according to a pre-designed method.

More specifically, the two parts of the sutures adjacent to each other in the fastener may be knotted so as to cross each other's warp yarns and warp yarns to be connected to one another.

Thus, when the non-sealing aortic valve replacement surgery is performed using the artificial heart valve set 200 of the present invention, the artificial heart valve 100 in which the skirt portion 137 is tightened before being inserted into the human body is provided and inserted into the human body. This can be done very easily. In addition, as the separation of the artificial heart valve 100 and the mounting tool 300 by the cutting of the connection member 151 of the operator upon insertion into the human aortic tube, the treatment time can be significantly shortened. . In addition, when the connecting member 151 is cut, the skirt portion 137 is instantaneously expanded, so that a stable attachment to the aortic canal can be achieved. In addition, as the skirt portion 137 of the present invention is made of a shape memory alloy, it can be stably restored to a preset shape in the human body condition to ensure the mounting of a more stable artificial heart valve 100.

The present invention described above is not limited by the above-described embodiments and the accompanying drawings, but is limited by the claims, which will be described later, and the configuration of the present invention is varied within a range not departing from the technical spirit of the present invention. Those of ordinary skill in the art to which the present invention pertains can readily appreciate that such changes and modifications can be made.

100: artificial heart valve 110: artificial valve
130: stent 131: wire
135: main body portion 137: skirt portion
150: fastener 151: connecting member
155: knot 170: outer shell
180: suture ring 181: silicone ring
190: sewing thread 191: sewing hole
200: artificial heart valve set
300: mounting tool 310: center
330: first fixing member 331: support
335: knot hanging hole 337: cutting groove
350: second fixing member 351: through hole
10, 11: wire 60: stagger
70: straight intersection 80: expansion mechanism

Claims (9)

In the artificial heart valve comprising an artificial valve and a stent,
The stent includes a hollow cylindrical body portion; and a hollow cone-shaped skirt portion extending from the body portion and gradually increasing in diameter in one direction.
At least the skirt portion is made of an artificial heart valve, characterized in that the wire is interwoven or cross-formed in a mesh form so that the entire structure can be self-restored by elastic deformation.
The method according to claim 1,
Further comprising a tightening portion for fixing the skirt portion in a compressed state below the diameter of the main body portion, artificial heart valve.
The method according to claim 2,
The fastening portion is composed of a suture-shaped connecting member capable of binding the edges of the skirt portion in a compressed state, characterized in that the compressed portion is released by removing, cutting or loosening the connecting member, thereby restoring the shape of the skirt portion. Heart valve.
The method according to claim 1,
The body portion and the skirt portion is made of wire is intertwined or cross-shaped in the form of a mesh,
Wherein the main body portion has a bent shape of the wires intertwined, and each bent portion includes a structure interwoven with a rhombic shape while crossing each other from top to bottom and bottom to top,
The skirt portion comprises a structure consisting of a weave-shaped weave so that the wires intertwined up and down once each time, artificial heart valve.
Artificial heart valve,
A set of artificial heart valves comprising a mounting tool provided with the artificial heart valve in a mounted form to seat the artificial heart valve in a desired position,
The artificial heart valve,
A stent, which is a fixed support means in the aortic canal of the heart connection site, and an artificial valve fixed to the stent,
The stent includes a hollow cylindrical body portion and a skirt portion of a hollow conical shape extending from the body portion and gradually increasing in diameter in one direction,
At least the skirt portion is made of a structure in which wires are woven in a mesh form or cross-formed so that the shape of the skirt can be restored by itself
The mounting tool,
With the center,
A first fixing member extending from the center and including a plurality of supports spaced radially apart, to support the structure of the mounted artificial heart valve,
It is formed at the center end of the position corresponding to the edge of the skirt part in the state where the artificial heart valve is mounted, and supports a suture-shaped connecting member that fixes the diameter of the skirt part to a diameter less than or equal to the diameter of the body part. An artificial heart valve set comprising a second fixing member.
The method according to claim 5,
The second fixing member, when the edge diameter of the skirt portion in the shape of a hollow cone is compressed below the diameter of the main body portion by the connecting member, the skirt to perform a central supporting role of concentric compression of the edge of the skirt portion The artificial heart valve set, characterized in that it comprises at least one through-hole through the connecting member extending from the part.
The method according to claim 6,
The through-hole has a structure that receives the connecting member extending from the skirt portion and guides it in the direction of the first fixing member,
The tension generated in the connecting member to compress the skirt portion is extended from the edge of the skirt portion and the connecting member guided in the direction of the first fixing member via the second fixing member is connected to the first fixing member. An artificial heart valve set, which is maintained.
The method according to claim 7,
The tension generated on the connecting member to compress the skirt portion is maintained by knotting the connecting member on the path of the connecting member that interconnects the edge of the skirt, the second fixing member, and the first fixing member. Meanwhile,
The artificial heart valve set, characterized in that the knot for maintaining the tension generated in the connecting member is formed on the outer surface of the first fixing member.
The method according to claim 8,
On the outer surface of the first fixing member, a knotting hole through which the connecting member can be inserted is formed,
The knot is formed on the outer surface of the first fixing member in a state in which the connecting member is inserted through the knot hanging hole,
When cutting one point of the connecting member in order to release the compression of the skirt portion, the knot is prevented from being separated from the mounting tool and lost due to the knot being caught in the knotting hole. The diameter of the engaging hole is characterized in that formed to be smaller than the diameter of the knot, artificial heart valve set.

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