Medical device and method for reconstructing a heart valve

Abstract

A medical device and method for reconstructing a semilunar heart valve in a patient with a congenital or acquired cardiac disease using biological or synthetic tissue, suitable for adult and child patients.

Description

Technical Field

[0001] The present invention relates to a medical device and method for reconstruction of a semilunar heart valve in patients with congenital or acquired heart disease, using biological or synthetic tissue. In particular, the present invention is applicable to adult and pediatric patients. Background Art

[0002] Cardiovascular disease is the leading cause of death worldwide. Among them, diseases of the semilunar heart valves - the aortic and pulmonary valves - are particularly prevalent.

[0003] Aortic valve disease (congenital or acquired) affects more than 70 million people worldwide and is characterized by valvular stenosis and / or regurgitation. The most common cause of aortic valve disease is degenerative disease, followed by rheumatic heart disease. Among congenital malformations, bicuspid aortic valve is the most common congenital heart defect.

[0004] Aortic stenosis is usually the result of degenerative remodeling of a normal tricuspid aortic valve or a congenitally abnormal valve, especially a bicuspid aortic valve. Whether it occurs in a bicuspid or normal tricuspid aortic valve, the degenerative changes that lead to aortic stenosis are caused by an active remodeling process involving inflammation and calcification.

[0005] Although degenerative disease is the most common cause of aortic regurgitation, a bicuspid aortic valve also predisposes individuals to aortic regurgitation, although less frequently than aortic stenosis. Rheumatic heart disease remains the second most common cause of aortic regurgitation in developed countries and the most common cause in developing countries.

[0006] It is now thought that at least one-third of people with bicuspid or unicuspid aortic valves will experience serious complications. Of the cases of aortic valve disease detected early in life, 80-95% are caused by bicuspid or unicuspid aortic valves. This condition may cause more mortality and morbidity than all other congenital heart defects combined.

[0007] The pulmonary valve is damaged in several congenital heart diseases, such as tetralogy of Fallot, pulmonary valvular stenosis, or pulmonary atresia. Pulmonary regurgitation is common in the evolution of patients undergoing surgery for tetralogy of Fallot or persistent truncus arteriosus.

[0008] Treatment for valvular heart disease involves valve repair or replacement, sometimes at the same time as repair of other heart defects. Open heart surgery is one of the treatments of choice, but percutaneous approaches may also be used in some cases. Traditional surgery is performed under general anesthesia, usually through an incision in the breastbone, with the help of a cardiopulmonary bypass machine. This machine performs the functions of the heart and lungs, oxygenating the blood and distributing it throughout the body, allowing surgeons to stop the heart and repair it.

[0009] In cases where valve replacement is necessary, mechanical or biological valves can be used, the latter usually made from cow or pig tissue. Human pericardium can also be used for valve reconstruction.

[0010] According to the closest prior art, the heart valve replacement method includes the following steps: cutting a portion of the pericardium; if the pericardium is human, placing it in a substance that can fix it (if it is from another source, it is already fixed); based on previous measurement results, selecting a template or mold that fits the patient's required size; using the template as a guide, cutting the pericardium portion to form the valve leaflets; suturing the valve leaflets to the arteries to form a heart valve.

[0011] Ozaki Shigeyuki in his patent JP5106019B2 discloses a template perforated with leaflets of different sizes for drawing and cutting artificial or biological membranes to obtain leaflets for replacement.

[0012] The valve replacement procedure described by Ozaki is for the aortic valve, is designed for adult patients, and involves the individual replacement of each leaflet. The size of each replacement leaflet is calculated based on the size of the native leaflet to be replaced (measured by the intercommissural distance). When the native leaflets are asymmetric, which is often the case, the reconstruction using the method proposed by Ozaki is also asymmetric, so that the intersection of the three leaflets is not necessarily in the center of the artery. This results in asymmetric sizes of the three aortic sinuses and uneven pressure distribution between them.

[0013] On the other hand, this approach is not accurate for bileaflet valve replacements, since these valves have only two native leaflets inserted, not three. Therefore, reconstruction of trileaflet valves cannot be performed in a standardized manner.

[0014] Although various approaches have been tried to find the best way to rebuild a heart valve, prior art methods still have shortcomings.

[0015] None of the existing heart valve replacements are designed specifically for children. There are no replacement valves designed specifically for children because children grow rapidly and valves with these characteristics would be too small soon after implantation. For some children who reach the size of an adult heart structure, replacement valves are available, but many of these valves require lifelong anticoagulation therapy. In addition, as the patient grows, prosthetic valve replacements due to dysfunction or mismatch are very common and carry a high risk of morbidity and mortality because the metal frame of the valve secures the native aortic annulus, preventing it from growing.

[0016] Furthermore, none of the currently proposed methods teaches how to automate some steps of the valve reconstruction method to reduce time, standardize the procedure, improve accuracy, and minimize surgical risks.

[0017] Therefore, there is a need for a method and medical device that can be used in adults and children, which can replace each patient's semilunar heart valve (aortic valve or pulmonary valve) with a new valve of appropriate size and can maintain normal function as the child grows, without stunting the growth of the artery that houses the valve and without requiring anticoagulation therapy. Summary of the invention

[0018] In one aspect of the present invention, a method for reconstructing a semilunar heart valve is disclosed, comprising the steps of:

[0019] a) fixation of a portion of biological or synthetic tissue, stretching the tissue using a first medical device, thereby firmly and tightly fixing the portion of the tissue, the first medical device comprising a shaping and marking assembly, which comprises two surfaces, the outer structure of which is similar to a semilunar leaflet, for shaping the biological or synthetic tissue; the first surface is provided with a first groove for marking the position on the leaflet where the surgical suture should be placed; and a fastening device for holding the shaping and marking assembly in place, which fixes the tissue between the two surfaces in a stretched and fixed manner;

[0020] b) creating a replacement leaflet by cutting tissue around a shaped and marked component of a first medical device having a semilunar heart valve leaflet structure;

[0021] c) placing sutures on the replacement valve leaflets at the locations indicated by the first grooves of the first medical device;

[0022] d) opening the patient's artery and inserting a second medical device therein, the second medical device comprising a mold capable of indicating the location of sutures to be placed for insertion of replacement leaflets;

[0023] e) passing a suture through the replacement valve leaflet at the position indicated by the first groove of the first medical device, then through the position indicated by the second medical device, and then through the arterial wall;

[0024] f) suturing the lowest point of the replacement valve leaflet to the arterial wall to secure it;

[0025] g) removing the first medical device;

[0026] h) suturing sutures;

[0027] i) Implanting a second and third replacement leaflet by repeating steps a) through h).

[0028] In another aspect of the present invention, a first medical device suitable for a semilunar heart valve reconstruction method is provided, comprising:

[0029] A shaping and marking component, comprising two surfaces, the outer structure of which is similar to a semilunar heart valve leaflet, for shaping biological or synthetic tissue, wherein the first surface is provided with a first groove for marking the position on the leaflet where a surgical suture should be placed; and

[0030] A fastening device for holding the shaping and marking assembly in place secures the tissue between the two surfaces in a tensioned and secure manner.

[0031] In another aspect, a second medical device suitable for use in a semilunar heart valve reconstruction method is provided, comprising a mold capable of indicating locations for placement of sutures for insertion of replacement leaflets.

[0032] In another aspect of the present invention, a third medical device suitable for a semilunar heart valve reconstruction method is provided, wherein the device includes a suture forceps and a handle, the suture forceps including a first surface at one end thereof and a second surface having at least one opening at the other end, the first surface being provided with a fastening device suitable for receiving and fixing a suture needle, the fastening device being arranged at a position where the suture needle must penetrate the target tissue, the suture needle passing through the opening when passing through the tissue, and the handle being able to bring the tip surfaces of the suture forceps close together so that multiple suture needles can pass through the target tissue at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Compared with the prior art currently known in the art, the structural features and advantages of the present invention will be more obvious in this specification in conjunction with the accompanying drawings, in which:

[0034] Figure 1 A possible embodiment of the first medical device according to the present invention is shown.

[0035] Figure 2 A possible embodiment of the second medical device in the present invention is shown.

[0036] Figure 3 Another possible embodiment of the second medical device in the present invention is shown.

[0037] Figure 4 A possible embodiment of the third medical device in the present invention is shown.

[0038] Figure 5 is a schematic diagram of the patient's body parts with the thorax and pericardium opened.

[0039] Figure 6 is a schematic diagram of a portion of a patient's body in which a first medical device has been used to secure a portion of the pericardium.

[0040] Figure 7 is a schematic illustration of a portion of a patient's body with a replacement valve leaflet cut around a shaped and marked component of a first medical device.

[0041] Figure 8 is a schematic diagram of an opening in an artery (in this embodiment, the aorta) of a patient.

[0042] Fig. 9 Schematic diagram of an artery of a patient configured with a second medical device.

[0043] Fig.10 is a schematic diagram of a patient's artery (in this embodiment, the aorta), wherein a suture first passes through the position indicated by the first groove of the shaping and marking component of the first medical device, and also passes through the position indicated by the second groove of the second medical device, and then passes through the replacement valve leaflet. The suture passing through the lowest point of the replacement valve leaflet is fixed to the arterial wall.

[0044] Fig.11 is a schematic diagram of an artery of a patient after the first and second medical devices have been removed.

[0045] Fig.12 is a schematic diagram of a patient's arteries with a replaced valve leaflet sutured.

[0046] Fig.13 is a schematic diagram of a patient's artery with all three replacement valve leaflets in place. DETAILED DESCRIPTION

[0047] The present invention will now be described in more detail in conjunction with preferred embodiments which should be considered only as examples and not as limitations.

[0048] Normal semilunar heart valves consist of three leaflets with specific anatomical and histological features. They are mobile and attached to the root of the aorta or pulmonary artery 404 in a semicircular shape. However, when the valve is diseased, the number of leaflets is not fixed: one leaflet (unicuspid valve), two leaflets (mitral valve), three leaflets (tricuspid valve) or four leaflets (quadricuspid valve). In addition, the anatomical and histological features of the valve are pathological.

[0049] The semilunar heart valve reconstruction method of the present invention includes replacing a diseased native valve having one, two, three or four leaflets with a symmetrical replacement valve 402 having three leaflets to adapt to the growth of the patient.

[0050] Replacement leaflet 402 is made of biological or synthetic tissue 400. Biological tissue 400 can be from human or animal. By way of example and not limitation, biologically derived materials include pericardium, heart valves, arteries and veins. Biological derivatives such as extracellular matrix or collagen and heparin coatings are also contemplated.

[0051] On the other hand, the synthetic material may include polymeric materials such as polytetrafluoroethylene (ie, expanded polytetrafluoroethylene), polyethylene terephthalate, polyurethane, polyvinyl chloride, and the like.

[0052] Preferably, the replacement leaflets 402 are made from autologous pericardium 400, that is, from the same patient.

[0053] In one aspect, the present invention relates to a first medical device 10 comprising:

[0054] A shaping and marking assembly 100 comprising two leaflet-shaped surfaces shaped to shape biological or synthetic tissue 400, these surfaces being provided with first grooves 102 to mark the locations where surgical sutures 500 are to be placed on the leaflets 402, and

[0055] The fastening device 300 of the shaping and marking assembly 100 is used to tighten the tissue 400 and fix it therein in a secure and non-moving manner.

[0056] In one possible embodiment, the surface of the shaping and marking component 100 is flat. In another embodiment, the surface is a concave or convex surface.

[0057] The surface of the shaping and marking assembly 100 may be made of plastic, but other possible materials are also contemplated, such as alloys of different metals.

[0058] The first groove 102 is located on the surface of the shaping and marking component 100, preferably at a position corresponding to the connection, adjacent edge and lowest point of the leaflet 402.

[0059] In some embodiments, the first groove 102 located at a position corresponding to the connection and adjacent edge of the leaflet 402 is internal (located a few millimeters away from the edge of the leaflet 402), while the first groove 102 corresponding to the lowest point of the leaflet 402 (central groove) is external.

[0060] like Figure 1 As shown, the shaping and marking assembly 100 has a curved lower edge, which is opposite to the suture edge 104, for placing the suture 500 that fixes the leaflet 402 to the artery 404, and an upper edge, also called free edge 106, where no suture is placed. The latter corresponds to the active edge of the apposition area that contacts the adjacent leaflet 402 to close the valve during diastole.

[0061] It can be seen that there are two types of first grooves 102. Some are wider because two sutures 500 are placed, the higher one corresponds to the upper U-shape, and the lower one corresponds to the lower U-shape. Therefore, in the first grooves 102, the grooves located at the upper and lower parts are narrower (only one needle passes through there), and the middle one is wider because two sutures 500 pass through there.

[0062] Preferably, at least one surface of the shaping and marking component 100 has roughness or serrations on at least one of its faces for securing the biological or synthetic tissue 400 when pressure is applied by the fastening means 300 .

[0063] In some embodiments of the present invention, the surface of the shaping and marking assembly 100 is further provided with a second groove 108 , which is used to facilitate breaking and removal when the leaflet 402 is in place and partially sutured in the aorta or pulmonary artery 404 .

[0064] Preferably, four second grooves 108 are provided, in such a way that the breaking of the surface is achieved by separating the side and central parts of the surface. Thus, for example, the side of the surface can be removed outwards and the central part can be removed towards the center and upwards.

[0065] The fastening device 300 may include two ratchet pliers, each of which is connected to one surface of the shaping and marking component 100. Preferably, the fastening device 300 includes a box lock 302 and a pin, a handle 304, a ratchet 306, and a ring handle 308. Each jaw 310 is connected to one surface of the shaping and marking part 100.

[0066] In other embodiments, the fastening device 300 is coupled to the surfaces of the shaping and marking assembly 100 in order to lock them together and symmetrically compress the biological or synthetic tissue 400 that will be used to construct the leaflets 402. The fastening device 300 can be coupled to the surfaces of the shaping and marking assembly 100 by magnetizing the two surfaces in opposite ways (positive-negative).

[0067] In still other possible embodiments, a clamp is used as the fastening device 300 .

[0068] Preferably, at least one surface of the shaping and marking assembly 100 is provided with a conductive material along the edge of its inner surface, which can automatically cut tissue in the form of leaflets when an electric current is applied thereto.

[0069] In another aspect of the present invention, a second medical device is provided that includes a mold capable of indicating the exact location of surgical sutures 500 for implanting replacement leaflets 402.

[0070] In one possible embodiment, the mold of the second medical device 20A is a semi-ring for insertion or implantation, wherein the semi-ring comprises an arched surface, and the arched surface comprises:

[0071] at least one first groove 202 for indicating at least one location where at least one surgical suture 502 must be placed to secure the device 20A to the wall of the artery 404; and

[0072] The second groove 204 is used to indicate the position where the surgical suture 500 should be placed. The surgical suture 500 previously passed through the position indicated by the first groove 102 of the first medical device 10 .

[0073] Preferably, if Figure 2 As shown, the mold of the second medical device 20A is an arched surface in the shape of the letter "U".

[0074] Additionally, the arcuate surface may be planar or concave or convex.

[0075] In an embodiment, the mold of the second medical device 20A includes at least three first grooves 202, two of which are located at its ends and one at its lowest point. In other embodiments, the second medical device 20A includes a single first groove 202 located at the lowest point.

[0076] In an embodiment of the present invention, the second groove 204 is located at a position corresponding to the connection and the adjacent edge of the leaflet 402. Preferably, the second groove 204 is internal.

[0077] Next, the attachment half ring 20A may include at least one third groove 206 designed to break, so that after the leaflets 402 are in place and partially sutured in the artery 404, the broken portion of the device 20A can be removed immediately without being entangled with the suture 500. Preferably, it includes at least one third groove 206 located at the lowest point, which may be the same as the groove (first groove 202) used to fix the device 20A.

[0078] Alternatively, in other possible embodiments of the present invention, the mold of the second medical device 20B takes a three-dimensional tubular form similar to the tricuspid crown 201. The design of this hollow mold can accommodate the circulation of the dye fluid therein. The mold is provided with holes 203 to allow the dye fluid to drain out, thereby marking the artery 404 where the leaflets 402 should be placed. The tip 201 of the mold corresponds to the connection between different leaflets 402.

[0079] like Figure 3 As shown, this three-dimensional tubular mold can be connected to a fluid diversion device, such as a hollow conduit 205. For example, this conduit can be supplied with liquid by a syringe 207 filled with a dye liquid.

[0080] Thus, in these embodiments, once the second medical device 20B is positioned within the artery 404 and injected with dye fluid, it is possible to mark the interior of the artery 404 at the precise location where sutures should be positioned to secure the leaflets 402 to its wall.

[0081] The size of the leaflets 402 and their position within the artery 404 are selected based on the diameter of the patient's artery 404 (which may be the aorta or the pulmonary artery, depending on the pathology) at the level of the sinotubular junction, preferably measured preoperatively by echocardiography or computed tomography. Thus, the size of the first medical device 10 and the second medical device 20A or 20B will vary depending on the size of the patient's native artery 404 to be treated.

[0082] On the other hand, a third medical device 30 is optionally provided that can simultaneously pass multiple sutures through tissue. The device 30 includes a suture forceps having a first surface 31, at one end of which a fastening device (such as a hole) suitable for receiving and fixing a suture needle is provided. These fastening devices are arranged at the position where the suture needle must penetrate the target tissue. The other end of the third medical device 30 includes a second surface 32 having at least one opening, through which the suture needle passes when passing through the tissue. The device 30 also includes a handle that can bring the tip surfaces 31 and 32 close together.

[0083] In certain embodiments of the present invention, the third medical device 30 is used to pass surgical sutures anchored in the valve leaflets 402 through the artery 404. In this case, the fastening means on the first surface 31 receive and secure a suture needle corresponding to at least one connection of the valve leaflets 402 that was previously passed through the tissue in the first medical device 10. These fastening means are placed at the precise location where the suture needle must penetrate the artery 404.

[0084] Preferably, the grooves of the second surface 32 may include a suture reinforcement material (eg, Teflon felt) so that the suture can be placed without damaging the wall of the artery 404 .

[0085] The first surface 31 is located inside the artery 404, and the second surface 32 is located outside, referring to the markings made by the second medical device 20A or 20B. By pressing the forceps, the suture needle simultaneously passes through the wall of the artery 404 and through the second surface 32, and also pierces the reinforcing material if there is any.

[0086] In some embodiments, the third medical device 30 only anchors the suture of one connection of one leaflet 402, which results in six repetitions (two for each of the three leaflets 402) being required to implant the entire valve.

[0087] In other embodiments, the third medical device 30 simultaneously anchors the sutures of two connections of a leaflet 402, and this process only needs to be repeated three times (once for each leaflet 402) to implant the entire valve.

[0088] In other embodiments, the third medical device 30 can simultaneously anchor the sutures at the junctions of adjacent leaflets 402, so that this process only needs to be repeated three times (once at each valve junction) to implant the entire valve.

[0089] In an alternative embodiment, the third medical device 30 is used to pass sutures through the replacement leaflets 402. In this case, a fastening device that receives and secures the suture needle is placed at the exact location where the leaflets 402 must be penetrated.

[0090] In yet other embodiments, the third medical device 30 is used to sew the leaflets 402 to the artery 404 , wherein the distance between the fastening device receiving and securing the suture needle is adjustable to enable the device 30 to pass the suture in the replacement leaflet 402 and the artery 404 .

[0091] In another aspect of the present invention, a method for reconstruction of a semilunar heart valve is disclosed, comprising the following steps:

[0092] a) fixing a portion of a stretched biological or synthetic tissue 400 using a first medical device 10, thereby firmly and tautly fixing the portion of the tissue 400;

[0093] b) creating a replacement leaflet 402 by cutting tissue 400 around the shaping and marking component 100 of the first medical device 10 having a leaflet-shaped structure;

[0094] c) placing suture 500 on replacement leaflet 402 at the position indicated by first groove 102 of first medical device 10;

[0095] d) opening the patient's artery 404 and inserting a second medical device 20A or 20B;

[0096] e) passing the suture 500 through the replacement valve leaflet 402 located at the position indicated by the first groove 102 of the first medical device 10, and then through the artery 404 located at the position indicated by the second medical device 20A or 20B;

[0097] f) suturing the lowest point of the valve leaflet 402 to the arterial wall to fix it;

[0098] g) removing the first medical device 10;

[0099] h) suturing suture 500;

[0100] i) Implanting a second and third replacement leaflet 402 by repeating steps a) through h).

[0101] Removal of the first medical device 10 may be achieved by breaking it at the second groove 108 for removal purposes.

[0102] In a preferred embodiment of the present invention, suturing the sutures according to steps h) and j) includes suturing the sutures 500 that have passed through the outside of the artery 404, and completing the leaflet implantation using a continuous suturing technique from the center to the previously sutured sutures.

[0103] In one possible embodiment of the present invention, when placing the second medical device 20A in step d): fix it to the artery 404 by passing the suture 502 through at least one position indicated by at least one first groove 202 of the second medical device 20A; in step g), additionally cut and remove the suture 502 fixing the second medical device 20A; repeat at least steps a) to c) to implant the third replacement leaflet 402, and then suture the suture 500 previously passed through the position indicated by the first groove 102 of the first medical device 10 to the artery 404, remove the first medical device 10, and suture the suture 500 outside the artery 404 to complete the leaflet implantation.

[0104] Removal of the second medical device 20A may be achieved by breaking it at the third groove 206 for removal purposes.

[0105] Furthermore, implantation of a third replacement leaflet 402 may be performed by repeating steps a) to h).

[0106] According to another embodiment of the present invention, when placing the second medical device 20B in step d), the step further comprises introducing a dye liquid into the second medical device 20B to mark inside the artery 404 where the sutures of the leaflets 402 must be placed.

[0107] Optionally, after step c), the method may further include anchoring the suture needle passing through the replacement leaflet 402 in the hole of the third medical device 30. Step e) is performed by placing the third medical device 30 having the first surface 31 inside the artery 404 and the second surface 32 outside thereof, and then pressing the handle to allow the suture needle to pass through the wall of the artery 404 and the second surface 32 while being anchored in the first surface 31.

[0108] Optionally, step c) of the method is performed using a third medical device 30, wherein the shaping and marking component 100 of the first medical device 10 is located between the first surface 31 and the second surface 32 of the third medical device 30. This is achieved by aligning the position of the hole on the first surface 31 of the third medical device 30 with the first groove 102 of the first medical device 10 and pressing the handle so that the suture needle is anchored on the first surface 31 and passes through the replacement leaflet 402.

[0109] The steps of the method will be described in detail below according to a preferred embodiment of the present invention.

[0110] like Figure 5 As shown, in the first stage of the proposed method, after opening the thoracic cavity 406, the pericardium 408 is opened in a cranial to caudal direction proximal to the phrenic nerve (preferably on the right side).

[0111] When the valve leaflet 402 needs to be manufactured, a portion of the stretched pericardium 400 is fixed with the first medical device 10, so that the portion is firmly fixed and stretched, such as Figure 6 shown.

[0112] After fixing the biological tissue 400 with the first medical device 10, the replacement leaflet 402 is cut around the shaping and marking component 100 having its shape, such as Figure 7 shown.

[0113] This cutting can be done before placing the replacement leaflets 402. This is particularly useful when using fresh autologous pericardium 400 so that irrigation is not performed for the shortest possible time.

[0114] The cutting can be at least partially automated, for example, in some cases the first medical device 10 is designed to cut via a conductive wire that can be powered by an electrosurgical device, or manually using a scalpel or scissors. Preferably, the free edge 106 of the shaping and marking assembly 100 coincides with the edge of the pericardium 400.

[0115] Suture 500 is then passed through replacement leaflet 402 at the location indicated by first notch 102. This may be done manually, needle by needle, or using third medical device 30 to pass suture 500 simultaneously.

[0116] In the first inner groove 102, corresponding to the connection and adjacent edges of the leaflets 402, a surgical suture 500 is in the shape of the letter "U" with a needle at each end. At the lower central groove 102 of the shaping and marking assembly 100, the same type of suture 500 is used to connect the leaflets 402 to the wall of the artery 404, and then the implantation is completed using a continuous suturing technique.

[0117] In the later stages of the method, such as Figure 8 As shown, the patient's 404 artery is opened.

[0118] Subsequently, the second medical device 20A or 20B is used to mark the location in the artery 404 through which the surgical suture 500 must be passed.

[0119] When the second medical device 20A is used, it is placed in the artery 404, such as Fig. 9 As shown, the device 20A is anchored to the arterial wall using a thin suture threaded through the first groove 202. The exact position of the device 20A is determined to ensure that it does not block the coronary artery opening 410. Fig.10 As shown, the U-shaped needle 500 has passed through the junction and adjacent edges of the replacement leaflets 402 and then through the wall of the artery 404 at the location indicated by the second notch 204 .

[0120] In contrast, when the second medical device 20B is used, it is placed in the artery 404 and injected with dye liquid, thereby marking it at the location where the suture 500 will be placed to anchor the leaflet 402. Subsequently, the U-shaped needle 500 is passed through the connection and adjacent edges of the replacement leaflet 402 and then through the location indicated by the dye liquid.

[0121] The process of threading the suture 500 may be accomplished manually, needle by needle, or by using a third medical device 30 to thread multiple sutures 500 simultaneously.

[0122] The lowest point of the leaflet 402 is then sutured to the wall of the artery 404 to secure it. Both needles of the suture 500 come out of the aortic sinus, that is, between the leaflet 402 and the wall of the artery 404.

[0123] According to this method, the needle 502 connecting the second medical device 20A (if used) to the wall of the artery 404 is cut. The device 20A is removed, preferably by breaking it through the middle groove 206 designed for this purpose. The shaping and marking component 100 of the first medical device 10 is also removed, preferably by breaking it through the second groove 108 provided for this purpose, and the leaflets 402 are free to access the artery 404 by pulling the suture 500. Fig.11 The leaflets 402 and artery 404 are shown after the first medical device 10 and the second medical device 20 have been removed.

[0124] The order in which devices are removed is undefined.

[0125] Subsequently, the U-shaped suture 500 is secured to the outer surface of the artery 404. The nadir suture 500 is then used to complete the implantation of the valve leaflet 402 by a continuous suturing technique. Fig.12 An artery 404 is shown in which valve leaflets 402 have been implanted.

[0126] Two petals 402 are planted in a similar manner and the above steps are repeated.

[0127] With respect to the third leaflet 402, it may not be necessary to use a second medical device 20 because the junction of the adjacent leaflets 402 can be used as a reference.

[0128] Fig.13 The patient's artery 404 is shown with all three replacement leaflets 402 in place.

[0129] For children, the size of the shaping and marking assembly 100 takes into account the expected growth rate of the patient, so the replacement leaflets 402 are oversized relative to the size of the artery 404. The second medical device 20A or 20B, unlike the first medical device 10, is not oversized, that is, its size corresponds to the diameter 404 of the native artery.

[0130] The reason leaflets 402 are oversized is so that as the child grows and arteries 404 become larger, the valve can continue to function properly.

[0131] The first characteristic of this oversizing is that the replacement leaflets are pinwheel-shaped.

[0132] The second characteristic is the coaptation zone, which is an increase in the coaptation area between the leaflets 402. A higher than normal coaptation zone allows the valve to maintain normal function even if the coaptation height decreases as the diameter of the artery 404 increases.

[0133] A third feature is that when an oversizing condition exists, the leaflets 402 extend downwardly below the plane of the annulus (also known as valve prolapse).

[0134] Unlike the prior art methods, in the method of the present invention, a coordinated replacement of the three leaflets 402 is performed, the native valve is completely removed, and a symmetrical valve is always obtained, in which the three identical leaflets 402 meet during valve closure in the center of the artery 404. The three resulting aortic sinuses are equal in size, resulting in an identical diastolic pressure distribution.

[0135] The method and medical device for reconstruction of a semilunar heart valve described in the present invention contribute to the automation and efficiency of surgical procedures, thereby reducing their time consumption and minimizing possible risks. In addition, they have other advantages: a) they can be used for both adult and pediatric patients (children), b) autologous tissue 400 can be used for valve replacement, c) any characteristics and number of autologous leaflets can be replaced, always achieving a symmetrical trileaflet valve, d) no anticoagulation is required after surgery, and e) the new valve does not prevent the growth of the valve ring and does not interfere with future valve replacement.

[0136] Finally, it is clear that the invention is not limited to the constructions exactly as illustrated and described; various modifications are possible without changing the spirit of the scope of the present description. Therefore, when put into practice, modifications and / or improvements may be introduced, all of which must be considered as variants of embodiment included within the scope of protection of this patent application.

Claims

1. A method for reconstructing a semilunar heart valve, comprising the following steps: a) fixing a portion of a biological or synthetic tissue (400), stretching the tissue using a first medical device (10) so as to firmly and tightly fix the portion of the tissue (400), wherein the first medical device (10) comprises a shaping and marking component (100), wherein the shaping and marking component (100) comprises two surfaces and an external structure similar to a semilunar leaflet, and is used to shape the biological or synthetic tissue (400); wherein the first surface is provided with a first groove (102) for marking the position on the leaflet (402) where the surgical suture (500) should be placed; the first medical device (10) further comprises a fastening device (300) for holding the shaping and marking component (100) in place, wherein the fastening device (300) fixes the tissue (400) between the two surfaces in a stretched and fixed manner; b) creating a replacement leaflet by cutting tissue (400) around said shaping and marking component (100) of said first medical device (10) having a semilunar heart valve leaflet structure; c) placing the suture (500) on the replacement leaflet (402) at the position indicated by the first groove (102) of the first medical device (10); d) opening the patient's artery (404) and inserting a second medical device (20A or 20B) therein, the second medical device (20A or 20B) comprising a mold capable of indicating the location of the suture (500) to be placed in order to insert the replacement leaflet (402); e) passing the suture (500) through the replacement valve leaflet (402) at the position indicated by the first groove (102) of the first medical device (10), then through the position indicated by the second medical device (20A or 20B), and then through the wall of the artery (404); f) suturing the lowest point of the replacement valve leaflet (402) to the wall of the artery (404) to fix it; g) removing the first medical device (10); h) suturing the suture (500); i) Implanting a second and third replacement leaflet by repeating steps a) through h) (402).

2. The method of claim 1, wherein the surface of the shaping and marking component (100) of the first medical device (10) is flat.

3. The method of claim 1, wherein the surface of the shaping and marking component (100) of the first medical device (10) is curved.

4. The method of claim 1, wherein a surface of the shaping and marking component (100) of the first medical device (10) is made of a plastic material.

5. A method as claimed in claim 1, wherein at least one surface of the shaping and marking component (100) of the first medical device (10) has roughness or fine teeth on at least one face thereof for fixing the biological or synthetic tissue (400) when pressure is applied by the fastening device (300).

6. A method as claimed in claim 1, wherein the first groove (102) of the first medical device (10) is located on the surface of the shaping and marking component (100), and its position corresponds to the connection, adjacent edge and lowest point of the leaflet (402).

7. A method according to claim 6, wherein the groove (102) located at a position corresponding to the connection and adjacent edge of the leaflet (402) is internal, and the groove (102) corresponding to the lowest point of the leaflet (402) is external.

8. The method of claim 1, wherein the fastening means (300) of the first medical device (10) comprises two ratchet handles, each of which is connected to one of the surfaces of the shaping and marking assembly (100).

9. The method of claim 1, wherein the fastening means (300) of the first medical device (10) is coupled to a surface of a shaping and marking assembly (100).

10. The method of claim 1, wherein the surface of the shaping and marking component (100) of the first medical device (10) is further provided with a second groove (108) for facilitating severing and removal when the leaflet (402) is in place and partially sutured within the artery (404).

11. The method according to claim 10, wherein the second grooves (108) are four in number and are arranged in such a way that the side and central portions of the surface are separated to break them.

12. The method of claim 1, wherein the mold of the second medical device (20A) is an arcuate surface, comprising: at least one first groove (202) for indicating at least one location at which at least one surgical suture (502) must be placed to secure the device (20A) to the wall of the artery (404); and A second groove (204) is used to indicate a position where a suture (500) should be placed, the suture having previously passed through a position indicated by the first groove (102) of the first medical device (10).

13. The method of claim 12, wherein the mold is a U-shaped arched surface.

14. The method of claim 12, wherein at least one of said first grooves (202) is internal.

15. The method of claim 12, wherein at least one of the first grooves (202) is a single groove (202) located at its lowest point.

16. The method of claim 12, wherein the second groove (204) is located at a position corresponding to a connection and an adjacent edge of the leaflet (402).

17. The method of claim 12, wherein the mold further comprises at least one third groove (206) for facilitating breaking and removal once the leaflet (402) is in place and partially sutured within the artery (404).

18. The method of claim 17, wherein at least one of the third grooves (206) is a single groove (206) located at its lowest point.

19. A method as claimed in claim 12, wherein in step d), the second medical device (20A) is positioned and fixed to the artery (404) by placing a suture (502) at a position indicated by at least one first groove (202) of the second medical device (20A); in step g), at least one suture (502) fixing the second medical device (20A) is further cut and removed; by at least repeating steps a) to c), a third replacement leaflet (402) is implanted, and then the suture (500) is sutured to the artery (404), and the suture is previously passed through the first groove (102) of the first medical device (10) The position indicated; the first medical device (10) is removed, and the suture (500) is sutured outside the artery (404) to complete the implantation of the leaflet (402).

20. The method as claimed in claim 1, wherein the mold of the second medical device (2B) is a tubular three-dimensional mold of a tricuspid crown (201) in a crown shape, which corresponds to the connection between different leaflets (402), and the mold is hollow to facilitate the circulation of the dye solution therein, and a hole (203) is provided to discharge the dye solution, thereby marking the artery (404) at the position where the leaflet (402) should be placed.

21. The method of claim 20, wherein the mold is connectable to a fluid distribution device (205) which can be fed by a syringe (207) filled with a dye solution.

22. The method according to claim 20, wherein: In step d), the second medical device (2B) is positioned, and furthermore, this step includes injecting a dye solution into the second medical device (2B) to mark the interior of the artery (404), ie the location where the suture (500) of the valve leaflet (402) should be placed.

23. The method of claim 1, wherein suturing the suture (500) in steps h) and j) includes suturing a suture through the outside of the artery (404), positioning the suture (500) at the lowest point from the center toward the previously sutured suture using a continuous suture technique to complete leaflet implantation.

24. The method according to claim 1, wherein after step c), the method includes fixing the suture needle passing through the replacement leaflet (402) in a fastening device of a third medical device (30), the third medical device (30) including a suture forceps and a handle, the suture forceps including a first surface (31) at one end thereof and a second surface (32) having at least one opening at the other end, the first surface (31) having a fastening device suitable for receiving and fixing the suture needle, the fastening device being arranged at a position where the suture needle must penetrate the target tissue, the suture needle passing through the opening when passing through the tissue, the handle being able to make the tip surfaces abut against each other so that multiple sutures pass through the target tissue simultaneously; step e) by placing the third medical device (30), positioning the first surface (31) inside the artery (404), positioning the second surface (32) outside the artery (404), and pressing its handle so that the suture needle anchored in the first surface (31) passes through the wall of the artery (404) and the second surface (32) simultaneously.

25. The method of claim 24, wherein the opening of the second surface (32) of the third medical device (30) comprises a reinforcing material for suturing, enabling it to be sutured without damaging the wall of the artery (404).

26. The method according to claim 1, wherein step c) is performed using a third medical device (30), which includes a suture forceps and a handle, the suture forceps including a first surface (31) at one end thereof and a second surface (32) having at least one opening at the other end, the first surface (31) having a fastening device suitable for receiving and holding a suture needle, the fastening device being arranged at a position where the suture needle must penetrate the target tissue, the suture needle passing through the opening when passing through the tissue, the handle being able to make the tip surfaces abut against each other so that multiple sutures pass through the target tissue at the same time, the shaping and marking component (100) of the first medical device (10) is positioned between the first and second surfaces of the third medical device (30), the position of the fastening device of the first surface (31) of the third medical device (30) is aligned with the first groove (102) of the first medical device (100), and the handle is pressed so that the suture needle fixed on the first surface (31) passes through the replacement leaflet (402) at the same time.

27. A first medical device (10), adapted for use in the method for reconstructing a semilunar heart valve as claimed in claim 1, comprising: A shaping and marking assembly (100) comprises two leaflet-shaped surfaces for shaping biological or synthetic tissue (400), wherein the surfaces are provided with a first groove (102) for indicating the position where a suture (500) should be placed on the leaflet (402); and a fastening device (300) for holding the shaping and marking assembly (100) in place, thereby securing the tissue (400) between the two surfaces in a stretched and fixed manner.

28. The first medical device (10) of claim 27, wherein the surface of the shaping and marking component (100) is flat.

29. The first medical device (10) of claim 27, wherein the surface of the shaping and marking component (100) is curved.

30. The first medical device (10) according to claim 27, wherein the surface of the shaping and marking component (100) is made of plastic material.

31. A first medical device (10) as described in claim 27, wherein at least one surface of the shaping and marking component (100) has roughness or fine teeth on at least one face thereof for fixing biological or synthetic tissue (400) when pressure is applied by the fastening device (300).

32. A first medical device (10) as described in claim 27, wherein the first groove (102) is located on the surface of the shaping and marking component (100), and its position corresponds to the connection, adjacent edges and lowest point of the leaflet (402).

33. The first medical device (10) of claim 32, wherein: The grooves (102) located at positions corresponding to the connection and adjacent edges of the leaflets (402) are internal, and the grooves (102) corresponding to the lowest points of the leaflets (402) are external.

34. A first medical device (10) as described in claim 27, wherein the fastening device (300) includes two ratchet handles, each of which is connected to one of the surfaces of the shaping and marking component (100).

35. The first medical device (10) of claim 27, wherein the fastening means (300) is coupled to a surface of the shaping and marking assembly (100).

36. The first medical device (10) of claim 27, wherein the surface of the shaping and marking component (100) is further provided with a second groove (108) for facilitating breaking and removal when the leaflet (402) is in place and partially sutured within the artery (404).

37. The first medical device (10) as described in claim 36, wherein the second grooves (108) are four in number and are arranged in such a way that the side and central parts of the surface are separated to break them.

38. A second medical device (20A or 20B) adapted for use in the method of reconstructing a semilunar heart valve as described in claim 1 above, comprising a mold capable of indicating the location at which sutures (500) are to be placed for implanting replacement leaflets (402).

39. The second medical device (20A) of claim 38, wherein the mold is an arcuate surface comprising: at least one first groove (202) configured to indicate at least one location for placement of at least one suture (502) that secures the device (20A) to the wall of the artery (404); and A second groove (204) is provided to indicate a location where a suture (500) should be placed, the suture (500) having previously passed through the leaflet (402) at the location indicated by the first groove (102) of the first medical device (10).

40. The second medical device (20A) of claim 39, wherein the mold is a U-shaped arched surface.

41. The second medical device (20A) of claim 39, wherein the at least one first groove (202) is internal.

42. The second medical device (20A) of claim 39, wherein the at least one first groove (202) is a single groove 202 located at its lowest point.

43. The second medical device (20A) of claim 39, wherein the second groove (204) is located at a position corresponding to the connection and adjacent edge of the leaflet (402).

44. The second medical device (20A) of claim 39, wherein the mold further comprises at least one third groove (206) for facilitating breaking and removal once the leaflet (402) is in place and partially sutured within the artery (404).

45. The second medical device (20A) of claim 44, wherein the at least one third groove (206) is a single groove (206) located at its lowest point.

46. ​​A second medical device (2B) as described in claim 38, wherein the mold is a three-dimensional tubular mold in the shape of a tricuspid crown (201) corresponding to the connection between different leaflets (402), the mold is hollow so that the dye solution can circulate therein, and is provided with holes (203) to remove the dye solution, thereby marking the artery (404) at the position where the leaflet (402) should be placed.

47. The second medical device (2B) according to claim 46, wherein the mold is connectable to a fluid dispensing device (205) which can be supplied by a syringe (207) containing the dye solution.

48. A third medical device (30), which is suitable for a method for reconstructing a semilunar heart valve as described in any one of claims 24-26, wherein the device comprises a suture forceps and a handle, the suture forceps comprising a first surface (31) at one end thereof and a second surface (32) having at least one opening at the other end, the first surface (31) being provided with a fastening device suitable for receiving and fixing a suture needle, the fastening device being arranged at a position where the suture needle must penetrate the target tissue, the suture needle passing through the opening when passing through the tissue, and the handle being capable of making the tip surfaces of the suture forceps stick to each other so that a plurality of the suture needles can pass through the target tissue at the same time.

49. The third medical device (30) of claim 48, wherein the opening of the second surface (32) includes a suture reinforcement material, thereby enabling suture placement without damaging the wall of the artery (404).

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